WO2007029252A2 - Method and device for treatment of congestive heart failure and valve dysfunction - Google Patents

Method and device for treatment of congestive heart failure and valve dysfunction Download PDF

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Publication number
WO2007029252A2
WO2007029252A2 PCT/IL2006/001040 IL2006001040W WO2007029252A2 WO 2007029252 A2 WO2007029252 A2 WO 2007029252A2 IL 2006001040 W IL2006001040 W IL 2006001040W WO 2007029252 A2 WO2007029252 A2 WO 2007029252A2
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WO
WIPO (PCT)
Prior art keywords
tissue anchor
heart tissue
heart
posterior
anterior
Prior art date
Application number
PCT/IL2006/001040
Other languages
French (fr)
Other versions
WO2007029252A3 (en
Inventor
Victor Segalescu
Nathan Sela
Original Assignee
Vital Valve (Israel) Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vital Valve (Israel) Ltd. filed Critical Vital Valve (Israel) Ltd.
Publication of WO2007029252A2 publication Critical patent/WO2007029252A2/en
Publication of WO2007029252A3 publication Critical patent/WO2007029252A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445Annuloplasty rings in direct contact with the valve annulus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00407Ratchet means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00411Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like actuated by application of energy from an energy source outside the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00778Operations on blood vessels
    • A61B2017/00783Valvuloplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00862Material properties elastic or resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0412Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from suture anchor body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2478Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
    • A61F2/2487Devices within the heart chamber, e.g. splints
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0001Means for transferring electromagnetic energy to implants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0004Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable

Definitions

  • the disclosed technique relates to devices and methods for mitral valve repair and treatment of congestive heart failure, in general, and to devices and methods for reshaping the mitral valve annulus, or similar anatomical structures, in particular.
  • cardiomyopathy in which the left ventricle and the annulus of the mitral valve, are gradually dilated and the ventricular contraction becomes less efficient.
  • the dilatation of the left ventricle and mitral valve annulus reduces coaptation of the leaflets of the mitral valve, thus bringing about valve regurgitation.
  • Surgical treatment of the mitral valve or restoration of the dilated mitral valve annulus improves the condition of patients suffering from heart failure, reduces utilization of healthcare services, and increases their survival expectancy.
  • Such a procedure involves reduction of annular size by implantation of a prosthetic ring. This procedure restores the normal shape and size of the left ventricles, improves mitral valve leaflets coaptation, and eliminates mitral regurgitation.
  • Such a procedure requires open-heart surgery and entails high mortality, due to poor medical condition of the patient. Therefore, this procedure is beneficial only to a small group of patients.
  • An implant can be delivered via a catheter to the left atrium or the left ventricle, in order to reshape the mitral valve or the left ventricle.
  • the implant is anchored across the mitral valve, in adjacent anatomical structures (e.g., in the coronary sinus), or across the heart chamber.
  • the implant shrinks or reshapes the mitral valve annulus, or the heart chamber.
  • Such a procedure requires anchoring of the implant in order to ensure that it remains attached to the tissue to which it was originally anchored. This procedure is similar to surgical ring annuloplasty.
  • US Patent No. 6,626,930 B1 issued to Allen et al., and entitled “Minimally Invasive Mitral Valve Repair Method and Apparatus”, is directed to a system for repairing a mitral valve of a heart.
  • the system includes a catheter tube and a vacuum source.
  • the catheter tube includes a pair of vacuum ports which are connected to the vacuum source.
  • the catheter tube includes two needles located within the vacuum ports, at a flat distal end of the catheter tube.
  • Each of the needles includes a toggle and a pusher.
  • Each of the toggles is connected to a suture thread.
  • a user maneuvers the catheter tube to an opening of the mitral valve, and pushes the needles so that the sharp ends of the needles pierce the leaflets of the mitral valve.
  • the user displaces the toggles, in order to anchor the ventricular side of the leaflets.
  • the user ties off the suture threads on the atrial side, to secure the leaflets.
  • US Patent No. 6,485,489 B2 issued to Teirstein et al., and entitled “Catheter System for Repairing a Mitral Valve Annulus”, is directed to a catheter system for compressively sandwiching the inner wall of an annular organ structure of a heart valve.
  • the catheter system includes a tissue contactor deployment mechanism, an electrode deployment means, a catheter shaft, a high frequency current generator, a plurality of needle electrodes, a tissue contactor member, and a handle.
  • the tissue contactor member includes a plurality of internal channels.
  • the handle includes a steering mechanism.
  • the handle is located at a proximal end of the catheter shaft.
  • the tissue contactor deployment mechanism and the electrode deployment means are located at the handle.
  • the tissue contactor member In a stowed state, the tissue contactor member is located at a distal end of the catheter shaft, within a lumen of the catheter shaft.
  • the needle electrodes are connected to the high frequency current generator.
  • the tissue contactor member is connected to the tissue contactor deployment mechanism.
  • the user advances the needle electrodes out of the lumen of the catheter shaft, through the internal channels, by employing the electrode deployment means.
  • the user activates the high frequency current generator, to provide high frequency heat to the collagen of the tissue of the annular organ structure, via the needle electrodes.
  • the staple device is located within a deployment catheter.
  • the staple device includes a first and a second tissue piercing leg portions, and a connection portion.
  • the connection portion has an arcuate configuration, and is located between the first and second tissue piercing leg portions.
  • the first and second tissue piercing leg portions terminate at a first and a second piercing ends, respectively.
  • the deployment catheter includes a tubular wall in which a slot is formed.
  • the staple device is located within the deployment catheter, adjacent the slot.
  • the deployment catheter includes a tool, for forcing the staple device out through the slot.
  • the staple device is made of a shape memory material.
  • a user positions the deployment catheter within the coronary sinus adjacent the mitral valve, and inflates an inflatable balloon, to urge the deployment catheter against the wall of the coronary sinus.
  • the user forces the staple device out of the slot, by employing the tool.
  • the first and second tissue piercing leg portions pierce the mitral valve annulus, and transform from an initial configuration to a final configuration.
  • the staple device tightens the mitral valve annulus, thereby terminating mitral valve regurgitation.
  • the radius of curvature of the mitral valve annulus in the final configuration is much larger than in the case of the initial configuration.
  • US Patent No. 7,052,487 B2 issued to Cohn et al., and entitled “Method and Apparatus for Reducing Mitral Regurgitation”, is directed to a system which reduces mitral regurgitation by forcing the posterior annulus of a mitral valve anteriorly.
  • the system includes a guidewire, a delivery catheter, and a push rod.
  • the delivery catheter includes an adjustable valve and a balloon.
  • the push rod includes a rigid elongated body and a removable proximal stiffener.
  • the rigid elongated body is located proximal to a distal end of the push rod.
  • the removable proximal stiffener is located between the rigid elongated body and a proximal end of the push rod.
  • a user maneuvers the guidewire to a coronary sinus of the heart of a patient.
  • the user passes the delivery catheter down the guidewire, until the distal end of the delivery catheter is positioned at the coronary sinus. Due to its flexible nature, the delivery catheter assumes the curvature of the coronary sinus.
  • the user removes the guidewire, and inflates the balloon, in order to secure the distal end of the delivery catheter within the coronary sinus.
  • the user passes the push rod through a central lumen of the delivery catheter, until the rigid elongated body is located adjacent the posterior annulus of the mitral valve, by employing the removable proximal stiffener.
  • the presence of the rigid elongated body causes a portion of the coronary sinus to assume a straight configuration, so that the posterior annulus of the mitral valve is force anteriorly, to improve mitral valve leaflet coaptation, and reduce mitral valve regurgitation.
  • US Patent No. 5,201,880 issued to Wright et al., and entitled
  • Mitral and Tricuspid Annuloplasty is directed to a method to minimize valvular insufficiency following implantation of a ring, which was previously performed to reduce valve regurgitation.
  • a user passes two drawstrings through loops within the ring, and tightens the external portions of the drawstrings, to constrict the ring, and to correct the valvular insufficiency.
  • US Patent application No. 2005/0143811 issued to Realyvasquez, and entitled “Methods and Apparatus for Mitral Valve Repair”, is directed to a device for percutaneous mitral valve repair.
  • the device includes a plurality of wired stents, a plurality of trans-vascular delivered fasteners and a ratchet mechanism.
  • the wired stents are connected with the ratchet mechanism to form a V shape device, wherein one of the wired stents forms a posterior leg and another wired stent forms an anterior leg.
  • Each of the wired stents includes a plurality of tines located at the ends opposite to the ratchet mechanism.
  • the device is delivered to the heart of a patient using a percutaneous intravascular catheter.
  • the two wired stents are deployed.
  • the anterior leg and the posterior leg are attached to the anterior part and the posterior part of the mitral valve annulus, respectively, by the tines which are located at each end of the anterior part and the posterior part.
  • the attachment of the anterior leg and the posterior leg to the mitral valve annulus is a temporary one.
  • the trans-vascular delivered fasteners permanently anchor the wired stents to the mitral valve annulus.
  • the physician rotates the catheter in a counterclockwise direction, in order to activate the ratchet mechanism.
  • the ratchet mechanism reduces the dimension between the wired stents, in order to achieve mitral valve competence.
  • US Patent Application No. 2004/0260393 A1 to Rahdert et al., and entitled “Devices, Systems, and Methods for Reshaping a Heart Valve Annulus”, is directed to an implant for shortening the antero-posterior axis of the mitral valve of the heart of a patient.
  • the implant includes a pair of struts and an intermediate rail.
  • the struts are connected to the intermediate rail at opposite ends of the rail.
  • Each strut includes an array of tissue penetrating barbs.
  • the implant is made of an elastic material and is in a relaxed position when it is being implanted.
  • the struts are spaced apart closer than the antero-posterior dimension of the targeted heart valve annulus.
  • the implant is delivered by a catheter, via the femoral vain or artery.
  • the implant is constrained in a straightened position within the sheath of the catheter.
  • a physician frees the strut of the posterior end from the sheath, and manipulates the strut to the posterior side of the annulus.
  • the physician anchors the posterior end of the strut to the posterior side of the annulus by employing the tissue penetrating barbs.
  • the physician uses a balloon to place the rail in tension and to seat the anterior end of the strut at the anterior side of the annulus.
  • the physician anchors the anterior end of the strut to the anterior side of the annulus by employing the tissue penetrating barbs.
  • the tension in the rail pulls both ends of the strut inwardly to shorten the antero-posterior axis of mitral valve annulus.
  • US Patent No. 6,997,951 B2 issued to Solem et al., and entitled “Method and Device for Treatment of Mitral Valve Insufficiency”, is directed to a device for reduction of the mitral valve annulus using a catheter based technology.
  • the device includes a proximal stent section, a distal stent section, a central stent section and a biodegradable structure.
  • the central stent section is connected between the proximal section and with the distal section.
  • the biodegradable structure is disposed on the central section.
  • the central section is capable to decrease its length.
  • the biodegradable structure keeps the central section in tension, so that the central stent section maintains its original length.
  • the device has a contracted delivery configuration, wherein the device is radially stowed within a delivery sheath of a catheter.
  • the proximal and distal sections of the device radially expand to be engaged with a blood vessel wall of the patient.
  • the proximal and distal sections are biologically anchored to the blood vessel wall.
  • the biodegradable structure disintegrates.
  • the tension in the central stent section is relieved, and the central stent section transforms to its shorter length, and draws the proximal and distal sections close to one another.
  • the force created by the central stent section remodels the mitral valve annulus.
  • Figure 1 is a schematic illustration of a cross section of a heart whose mitral valve annulus and left ventricle are dilated;
  • Figure 2A is a schematic illustration of a top view of an implant to be attached to the mitral valve annulus of the heart of Figure 1 , in order to reduce the antero-posterior diameter of the mitral valve annulus and the volume of the left ventricle of the heart of Figure 1 ;
  • Figure 2B is a schematic illustration of a side view of the implant of Figure 2A;
  • Figure 3A is a schematic illustration of a top view of an implant, constructed and operative according to an embodiment of the disclosed technique, to be attached to the mitral valve annulus of the heart of Figure
  • Figure 3B is a schematic illustration of a side view of the implant of Figure 3A;
  • Figure 4A is a schematic illustration of a male portion of the heart tissue anchor assembly of the implant of Figure 3B;
  • Figure 4B is a schematic illustration of a female portion of the heart tissue anchor assembly of Figure 3B
  • Figure 4C is a schematic illustration of a perspective exploded view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively;
  • Figure 4D is a schematic illustration of a perspective view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively, during engagement
  • Figure 4E is a schematic illustration of a perspective view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively, after engagement;
  • Figure 5A is a schematic illustration of an implant, attached to the mitral valve annulus of Figure 1 , prior to decrease in the opening of the mitral valve annulus, and constructed and operative according to another embodiment of the disclosed technique;
  • Figure 5B is a schematic illustration of the implant of Figure 5A, after reducing the opening of the mitral valve annulus
  • Figure 6A is a schematic illustration of a bottom view of an implant, generally referenced 260, constructed and operative according to a further embodiment of the disclosed technique
  • Figure 6B is a schematic illustration of a top view of the implant of Figure 6A.
  • Figure 6C is a schematic illustration of a side view of the implant of Figure 6A;
  • Figure 7A is a schematic illustration of a bottom view of an implant, constructed and operative according to another embodiment of the disclosed technique
  • Figure 7B is a schematic illustration of a top view of the implant of Figure 7A;
  • Figure 7C is a schematic illustration of a side view of the implant of Figure 7A;
  • Figure 8A is a schematic illustration of a top view of an implant, constructed and operative according to a further embodiment of the disclosed technique
  • Figure 8B is a schematic illustration of a side view of the implant of Figure 8A;
  • Figure 8C is a schematic illustration of the implant of Figure 8A, in a contracted state
  • Figure 9A is a schematic illustration of a patient, subject to an external source of energy
  • Figure 9B is a schematic illustration of a patient, subject to an internal source of energy
  • Figure 1OA is a schematic illustration of a bottom view of an implant, constructed and operative according to another embodiment of the disclosed technique
  • Figure 1OB is a schematic illustration of a top view of the implant of Figure 10A;
  • Figure 10C is a schematic illustration of a side view of the implant of Figure 10A
  • Figure 11A is a schematic illustration of a bottom view of an implant, constructed and operative according to a further embodiment of the disclosed technique
  • Figure 11 B is a schematic illustration of a top view of the implant of Figure 11 A
  • Figure 11C is a schematic illustration of a side view of the implant of Figure 11 A;
  • Figure 12A is a schematic illustration of a bottom view of an implant, constructed and operative according to another embodiment of the disclosed technique;
  • Figure 12B is a schematic illustration of a top view of the implant of Figure 12A;
  • Figure 12C is a schematic illustration of a side view of the implant of Figure 12A;
  • Figure 13A is a schematic illustration of a system for deploying an implant from a sheath, to be implanted on a heart valve annulus, constructed and operative according to a further embodiment of the disclosed technique, the implant being in a stowed position within the sheath;
  • Figure 13B is a schematic illustration of the implant of Figure 13A, while being deployed
  • Figure 13C is a schematic illustration of the implant of Figure 13A, while being deployed
  • Figure 13D is a schematic illustration of a system for deploying an implant from a sheath, to be implanted on a heart valve annulus, constructed and operative according to another embodiment of the disclosed technique, the implant being in a stowed position within the sheath;
  • Figure 13E is a schematic illustration of the implant of Figure 13D, while being deployed;
  • Figure 14A is a schematic illustration of the implant of Figure
  • Figure 14B is a schematic illustration of the implant of Figure 13B in a deployed position, while being located within the left atrium;
  • Figure 14C is a schematic illustration of the implant of Figure
  • Figure 14D is a schematic illustration of the implant of Figure 14C, being permanently anchored to the mitral valve annulus and disengaged from the catheter;
  • Figure 15A is a schematic illustration of a system for deploying an implant from a sheath, to be implanted on a heart valve annulus of the heart of a patient, constructed and operative according to a further embodiment of the disclosed technique, the implant being in a stowed position within the sheath;
  • Figure 15B is a schematic illustration of the implant of Figure 15A, while being deployed;
  • Figure 15C is a schematic illustration of the implant of Figures 15A and 15B;
  • Figure 16 which is a schematic illustration of an implant constructed and operative according to another embodiment of the disclosed technique;
  • Figure 17 which is a schematic illustration of an implant constructed and operative according to a further embodiment of the disclosed technique
  • Figure 18A is a schematic illustration of a system for deploying an implant from a sheath, constructed and operative according to another embodiment of the disclosed technique, the implant being stowed within the sheath;
  • Figure 18B is a schematic illustration of the implant of Figure 18A, in a deployed position
  • Figure 19A is a schematic illustration of a system for deploying an implant from a sheath, constructed and operative according to a further embodiment of the disclosed technique, the implant being stowed within the sheath;
  • Figure 19B is a schematic illustration of the implant of Figure 19A, in a deployed position
  • Figure 2OA is a schematic illustration of a system for deploying an implant from a sheath, constructed and operative according to another embodiment of the disclosed technique, the implant being stowed within the sheath;
  • Figure 2OB is a schematic illustration of the implant of Figure 2OA, in a deployed position; and Figure 21 is a schematic illustration of a method for reducing the antero-posterior diameter of heart valve annulus of a malfunctioning heart valve of the heart of the body of a patient, operative according to a further embodiment of the disclosed technique.
  • DETAILED DESCRIPTION OF THE EMBODIMENTS
  • the disclosed technique overcomes the disadvantages of the prior art by providing a device and a method for reducing the displacement between two anchors of a heart valve implant, anchored to a heart valve, after anchoring the anchors to the heart valve annulus, and after completion of the heart valve implant procedure on the patient (i.e., removal of the catheter from the body of the patient, in case a catheter is employed for delivering the implant, suturing the incision of the chest of the body of the patient, in case of an open heart surgery, or removal of all the surgical instruments, in case of a minimal invasive surgery).
  • the displacement between the anchors is decreased at any desired time period after implanting the device, for example after days, weeks or months in one step or progressively reduced in steps, for example over the course of a few days, weeks or months.
  • the displacement between the anchors can be reduced either in one session or in several sessions.
  • the first displacement reduction session can be performed either immediately after the initial implant, or at a selected time thereafter.
  • the displacement between the anchors is decreased at a desirable time period after completion of the heart valve implant procedure. Therefore, heart tissue is allowed to heal and grow, and the anchors are allowed to gain better adherence to the attachment region (i.e., the heart valve annulus and other adjacent tissue), thereby reducing the probability of ruptures of the heart valve tissue at the site of the anchors, and reducing the probability of detachment of the anchors from the heart valve annulus. Performing the reduction of the displacement between the anchors gradually (e.g., in several sessions), further minimizes the probability of tissue rupture and of detachment of the anchors from the heart valve annulus.
  • the two anchors of the heart valve implant are deployed from a catheter which delivers the heart valve implant to the heart valve, simultaneously, thereby expediting the anchoring procedure of the anchors to the heart valve annulus.
  • This aspect of the disclosed technique is beneficial to the physician, since the implant procedure is performed while the heart of the patient keeps beating and blood continues to flow. Therefore, the physician has to be provided with a device, which minimizes the time necessary to perform the heart valve implant procedure, and furthermore, interferes with the normal function of the heart, as little as possible.
  • the direction of the force applied to the two heart tissue anchors of the heart valve implant when reducing the displacement between the heart tissue anchors, is substantially parallel to the inner heart contour wall to decrease the probability of ruptures in the heart tissue, or detachment of the heart tissue anchors from the heart valve annulus, while the two heart tissue anchors are being moved toward one another.
  • heart valve herein below, refers to an anatomical valve of a heart of a patient, such as the mitral valve or the tricuspid valve.
  • heart valve axis refers to a selected axis of a heart valve, for example, the antero-posterior axis of the mitral heart valve, or the axis defined by the posterior and septal leaflet portion of the tricuspid annulus, or the axis defined by septal leaflet annulus and the commissure between anterior and posterior leaflet of the tricuspid valve.
  • the following description shall refer mainly to the antero-posterior axis.
  • the disclosed technique can be implemented for any other axis within a heart valve.
  • the implant according to the disclosed technique includes a mechanism herein below referred to as "displacement reduction mechanism", which applies a force on the heart tissue anchors, to move the heart tissue anchors toward one another, thereby reducing the antero-posterior diameter of the heart valve.
  • the disclosed technique can be employed for repairing a mitral valve, a tricuspid valve, and other similar anatomical structures.
  • the disclosed technique can be employed in the body of humans as well as mammalians.
  • Figure 1 is a schematic illustration of a cross section of a heart generally referenced 100, whose mitral valve annulus and left ventricle are dilated.
  • Figure 2A is a schematic illustration of a top view of an implant generally referenced 130, to be attached to the mitral valve annulus of the heart of Figure 1 , in order to reduce the antero-posterior diameter of the mitral valve annulus and the volume of the left ventricle of the heart of Figure 1.
  • Figure 2B is a schematic illustration of a side view of the implant of Figure 2A.
  • a left ventricle 102 and a mitral valve annulus 104 are dilated. Due to increase in the antero-posterior diameter of mitral valve annulus 104, the coaptation between mitral valve leaflets 108 is poor, therefore causing mitral valve regurgitation.
  • the devices and methods according to the disclosed technique provide reduction of the antero-posterior diameter of mitral valve annulus 104, thus improving coaptation of leaflets 108, and reshaping left ventricle 102. Reduction of the antero-posterior diameter of mitral valve annulus 104 also improves the physical condition of a patient who suffers from dilated cardiomyopathy.
  • This improvement is brought about by reducing valve regurgitation, reducing the volume of left ventricle 102, reducing the mechanical stress in the tissue of left ventricle 102, reducing oxygen consumption, restoring the normal heart anatomy, improving backing of left ventricle shortening and torque, increasing cardiac output, increasing left ventricle hemodynamic efficiency, and the like.
  • implant 130 includes an elastic movement provider 132, at least a first heart tissue anchor 134A, and at least a second heart tissue anchor 134B.
  • Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B includes a set of anchors 136A ( Figure 2B) and 136B, respectively, to provide attachment of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B with mitral valve annulus 104.
  • Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B are coupled with two ends of elastic movement provider 132.
  • Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can slide relative to elastic movement provider 132, toward one another.
  • Implant 130 is to be implanted in a left atrium 106 ( Figure 1 ) and attached to mitral valve annulus 104, to reduce the antero-posterior diameter of mitral valve annulus 104.
  • Implant 130 can be implanted by various methods, such as percutaneous transluminal catheter delivery, minimal invasive catheter delivery, or open heart surgery.
  • Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B are attached to mitral valve annulus 104 across the antero-posterior axis (for example, attaching anterior heart tissue anchor 134A to the anterior region of mitral valve annulus 104, and attaching posterior heart tissue anchor 134B to the posterior region of mitral valve annulus 104), such that an axis (not shown) which connects anterior heart tissue anchor 134A and posterior heart tissue anchor 134B, is substantially parallel to the antero-posterior axis of mitral valve annulus 104.
  • Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be attached to mitral valve annulus 104 in different ways, such as employing the set of anchors 136A and 136B, respectively, an adhesive, vacuum, suture, staple, or a combination thereof.
  • anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be initially attached to mitral valve annulus 104 by applying vacuum or pressure, and then attached by employing the set of anchors 136A and 136B, respectively.
  • Each of the set of anchors 136A and 136B can be inclined to a surface (not shown), in order to increase the effective penetration depth in the tissue of mitral valve annulus 104.
  • Each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is constructed from a biocompatible material, such as Polytetrafluoroethylene, Silicone, Polyurethane, Nitinol, and the like. Additionally, anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be constructed in a form which promotes tissue in-growth, for example, by providing a plurality of perforations, in order to allow tissue in-growth, and the like. Each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be constructed from a biocompatible material which promotes tissue in-growth, in order to promote adherence of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to the tissue of mitral valve annulus 104. Alternatively, each of the bottom surfaces of the heart tissue anchors 134A and can be coated with a biocompatible material, which promotes tissue in-growth.
  • Each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is made of a rigid material.
  • each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is made of a flexible material.
  • anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be made from a flexible material, in order to allow anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to be folded within a sheath (not shown).
  • anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to conform to the contour of atrial wall 114, when implant 130 is deployed from the sheath, by forcing implant 130 out from the sheath (e.g., by employing an inflatable balloon).
  • the contour of each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is in form of a closed curve, such as circle, ellipse, and the like.
  • the contour of each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is in form of a polygon, such as rectangle, square, trapezoid, triangle, pentagon, hexagon, and the like.
  • the shape of each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is flat.
  • the shape of each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is in form of a curved surface.
  • each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be constructed such that a width W thereof, is greater than a width (not shown) of mitral valve annulus 104 (i.e., between several millimeters and a few centimeters).
  • a width W thereof is greater than a width (not shown) of mitral valve annulus 104 (i.e., between several millimeters and a few centimeters).
  • Employing anterior heart tissue anchor 134A and posterior heart tissue anchor 134B of such a width increases the probability of a stronger bond.
  • the surface area, which includes mitral valve annulus 104, and adjacent tissue either of atrial wall 114 above and of leaflets 108 below, is herein below referred to as "attachment region".
  • anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be with a width W equal or smaller that the width of mitral valve annulus 108. In this case, a higher level of precision is required on the part of the physician, in order to attach anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to mitral valve annulus 104, in an accurate manner.
  • anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be stowed within the sheath during the delivery, and deployed from the sheath.
  • a flexible element such as elastic movement provider 132 is employed to fold anterior heart tissue anchor 134A and posterior heart tissue anchor 134B, in a stowed position within the sheath.
  • Elastic movement provider 132 is employed for the deployment of implant 130.
  • elastic movement provider 132 can be employed for catheter based delivery of implant 130, as well as for deployment of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B, and attachment of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to mitral valve annulus 104.
  • Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B are coupled to elastic movement provider 132 and can slide towards its center. This movement is provided for example, by providing a groove (not shown), in each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B, within which elastic movement provider 132 can move, thereby allowing relative movement between each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B and elastic movement provider 132.
  • the cross section of elastic movement provider 132 is in form of a closed curve (e.g., circle, ellipse), or a polygon (e.g., square, rectangle, triangle, trapezoid, hexagon, pentagon).
  • Elastic movement provider 132 can be in form of a ribbon, wire, and the like.
  • Elastic movement provider 132 includes two connected wings, the flexibility of which enables deployment of implant 130, such that an angle between the two wings is between 120° to180°. Other deployment angles can be selected according to the application.
  • the arrangement of implant 130 as set forth in Figure 2B, enables simultaneous deployment and anchoring of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to mitral valve annulus 104.
  • Elastic movement provider 132 can be substantially rigid at a central portion thereof, and substantially flexible (e.g., radial flexibility) at regions away from the central portion (i.e., at the distal ends).
  • Elastic movement provider 132 ensures that implant 130 conforms to the curvature of left atrium 106, mitral valve annulus 104 and leaflets 108, and that a desired force is acting on the attachment region of mitral valve annulus 104, during the deployment,
  • Elastic movement provider 132 can be constructed such that it is substantially elastic along a longitudinal axis 562 thereof.
  • Elastic movement provider 132 can be constructed from a biocompatible material which inhibits tissue in-growth.
  • elastic movement provider 132 can be coated with a biocompatible material which inhibits tissue in-growth.
  • the physician can employ a plurality of implants similar to implant 130.
  • the implant can include more than two heart tissue anchors.
  • the heart tissue anchors are attached to an anterior portion and to a posterior portion of the mitral valve annulus, such that the axis connecting the heart tissue anchors is substantially parallel with the antero-posterior axis of the mitral valve annulus.
  • the implant can include more than one elastic movement provider, each coupled with a plurality of heart tissue anchors.
  • the elastic movement provider can be constructed in a star topology (e.g., an elastic movement provider having a plurality of legs, meeting at a common point, for example, in form of the letter Y or X).
  • the physician can select the quantity of heart tissue anchors, the size of each of the heart tissue anchors, and the length of each of the heart tissue anchors, among a given set of heart tissue anchors, of different sizes, and different lengths.
  • Figure 3A is a schematic illustration of a top view of an implant generally referenced 160, constructed and operative according to an embodiment of the disclosed technique, to be attached to the mitral valve annulus of the heart of Figure 1 , in order to reduce the antero-posterior diameter of the mitral valve annulus and the volume of the left ventricle of the heart of Figure 1.
  • Figure 3B is a schematic illustration of a side view of the implant of Figure 3A.
  • Figure 4A is a schematic illustration of a male portion of the heart tissue anchor assembly of the implant of Figure 3B.
  • Figure 4B is a schematic illustration of a female portion of the heart tissue anchor assembly of Figure 3B.
  • Figure 4C is a schematic illustration of a perspective exploded view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively.
  • Figure 4D is a schematic illustration of a perspective view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively, during engagement.
  • Figure 4E is a schematic illustration of a perspective view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively, after engagement.
  • Implant 160 includes an elastic movement provider 162 and heart tissue anchor assemblies 164A and 164B. Implant 160 is similar to implant 130 ( Figure 2A), except that each of heart tissue anchor assemblies 164A and 164B is constructed such that implant 160 provides mechanical protection to mitral valve annulus 104 ( Figure 1 ) and the heart tissue in the vicinity of the deployment site.
  • each of heart tissue anchor assemblies 164A and 164B includes a male portion 166 and a female portion 168.
  • Male portion 166 includes a plurality of barbs 170 protruding from a surface 172 of male portion 166. Each of barbs 170 is slanted to surface 172.
  • Female portion 168 includes a plurality of perforations 174.
  • the quantity, diameter and location of perforations 174 matches those of barbs 170.
  • the contour of male portion 166 is substantially identical with that of female portion 168.
  • the contour of each of male portion 166 and female portion 168 can be either a polygon (e.g., square, rectangle, trapezoid, triangle), or a closed curve (e.g., circle, ellipse).
  • male portion 166 and female portion 168 are slidably coupled together.
  • female portion 168 can include a longitudinal groove (not shown), and male portion 166 can include a longitudinal protrusion (not shown), to match the longitudinal groove, such that male portion 166 can slide on female portion 168 along a direction designated by an arrow 176 ( Figure 4D).
  • the longitudinal protrusion is locked with the longitudinal groove, in order to prevent disengagement of male portion 166 from female portion 168, in a direction perpendicular to the direction of arrow 176.
  • barbs 170 are located outside of perforations 174, and thus, a bottom surface 178 of female portion 168 provides mechanical protection of mitral valve annulus 104, leaflets 108, and atrial wall 114, from barbs 170. This provision allows the physician to position heart tissue anchor assemblies 164A and 164B, at the desired location, and then to adjust the position of heart tissue anchor assemblies 164A and 164B, to a desired location, without injuring the heart tissue.
  • male portion 166 Following deployment and upon being placed at a required position, male portion 166 is moved relative to female portion 168, along the direction of arrow 176, wherein barbs 170 enter the respective perforations 174, male portion 166 locks into female portion 168, and barbs 170 pierce the tissue of mitral valve annulus 104, thereby implanting implant 160 on mitral valve annulus 104, leaflets 108, and atrial wall 114 during deployment and positioning of the implant. It is noted that the description herein above is one example to provide protection of mitral valve annulus 104, and that other methods can be employed to protect the heart tissue. Reference is now made to Figures 5A, and 5B.
  • Figure 5A is a schematic illustration of an implant, generally referenced 220, attached to the mitral valve annulus of Figure 1 , prior to decrease in the opening of the mitral valve annulus, and constructed and operative according to another embodiment of the disclosed technique.
  • Figure 5B is a schematic illustration of the implant of Figure 5A, after reducing the opening of the mitral valve annulus.
  • Implant 220 includes an elastic movement provider 222, an anterior heart tissue anchor 224A, and a posterior heart tissue anchor 224B.
  • Anterior heart tissue anchor 224A and posterior heart tissue anchor 224B are coupled to elastic movement provider 222 and can slide towards its center.
  • a first thread 230A connects heart tissue anchor 224A , to a manifold (not shown) located outside the body of the patient.
  • a second thread 230B connects heart tissue anchor 224B to the manifold.
  • first thread 230A and second thread 230B are employed by employing the manifold, thereby moving heart tissue anchor 224A in a direction designated by an arrow 232A, and heart tissue anchor 224B, in a direction designated by an arrow 232B and reduces the displacement between anterior heart tissue anchor 224A and posterior heart tissue anchor 224B.
  • This action reduces the antero-posterior diameter of mitral valve annulus 228 by a desired amount ( Figure 5B), thereby improving coaptation of mitral valve leaflets 234.
  • first thread 230A or second thread 230B can be pulled only one of first thread 230A or second thread 230B to reduce the displacement between anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, and to reduce the probability of detachment of heart tissue anchors 224A and 224B from the attachment region.
  • Such a selection can be made in order to reduce the probability of ruptures in the tissue of mitral valve annulus 228, and the probability of detachment of heart tissue anchors 224A and 224B from the attachment region.
  • the physician can reduce the antero-posterior diameter of mitral valve annulus 228, after completion of the heart valve implant procedure (e.g., days, weeks, or months thereafter), in a percutaneous transluminal catheter delivery procedure, via first thread 230A and second thread 230B.
  • the catheter includes a position fixation mechanism 236 located at a tip thereof.
  • Position fixation mechanism 236 can be reversibly coupled with the catheter, for example, by a screw thread, a latch, and the like.
  • Position fixation mechanism 236 is a device, which is employed for maintaining the antero-posterior diameter of mitral valve annulus 228, at the desired value.
  • position fixation mechanism 236 can be in form of a clamp, which is coupled with the manifold by a position fixation thread (not shown).
  • the physician locks first thread 230A and second thread 230B together, after pulling them by the desired amount, and then maintains the diameter of mitral valve annulus 228 at the desired value, by clamping first thread 230A and second thread 230B together, by position fixation mechanism 236.
  • Anterior heart tissue anchor 224A and posterior heart tissue anchor 224B can be maintained in the desired position, without employing position fixation mechanism 236, for example, by twisting first thread 230A and second thread 230B and then tying them together. Position fixation mechanism 236 can be employed additionally, to secure the tie.
  • the procedure of maintaining heart valve anchors 224A and 224B at the desired position, as described herein above, can be performed in an open heart surgery, as well as percutaneous transluminal catheter intervention, and minimal invasive surgery.
  • first thread and the second thread can merge together to a single thread, to enable the physician to pull the first thread and the second thread, by pulling only the single thread.
  • catheter is directly coupled with a surface of elastic movement provider 222. Therefore, tensions in first thread 230A and second thread 230B acting on anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, are substantially tangent with the surface of mitral valve annulus 228, and hence forces which tend to tear mitral valve annulus 228
  • Decreasing the anter-posterior diameter of mitral valve annulus 228 in one step induces a large amount of stress to the heart wall, and imposes a sudden adjustment of the heart to its sudden change of shape o and volume.
  • Decreasing the antero-posterior diameter of mitral valve s annulus 228 after days to months following the implant procedure also increases the adherence of anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, to the adjacent tissue before exerting on anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, significant forces during the reshaping process.
  • the physician can perform a first contraction step immediately after anchoring implant 220, to achieve an initial reduction in the length of antero-posterior diameter of mitral valve annulus 228.
  • the physician reduces the 5 antero-posterior diameter of mitral valve annulus 228 by a percutaneous transluminal catheter procedure.
  • a catheter (not shown) is introduced in the left atrium, for example by methods described herein below.
  • the catheter includes a device for grabbing either of first thread 230A and second thread 230B, or both, or for grabbing position fixation mechanism o 236.
  • the physician can then pull first thread 230A and second thread 230B, in order to move anterior heart tissue anchor 224A and posterior heart tissue anchor 224B toward one another, and reduce the antero-posterior diameter of mitral valve annulus 228.
  • implant 220 can include a device for automatically securing the required distance between anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, once anterior heart tissue anchor 224A and posterior heart tissue anchor 224B have been manually brought to that required position, for example as described herein below in connection with Figure 6A.
  • implant 220 can include a grabbing element (not shown - e.g., a hook) coupled with each of anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, to allow the physician to grab each of anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, in order to move anterior heart tissue anchor 224A and posterior heart tissue anchor 224B toward one another.
  • a grabbing element (not shown - e.g., a hook) coupled with each of anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, to allow the physician to grab each of anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, in order to move anterior heart tissue anchor 224A and posterior heart tissue anchor 224B toward one another
  • Figure 6A is a schematic illustration of a bottom view of an implant, generally referenced 260, constructed and operative according to a further embodiment of the disclosed technique.
  • Figure 6B is a schematic illustration of a top view of the implant of Figure 6A.
  • Figure 6C is a schematic illustration of a side view of the implant of Figure 6A.
  • Implant 260 includes an elastic movement provider 262, and two heart tissue anchors 264A and 264B.
  • Elastic movement provider 262 includes a plurality of protrusions 266.
  • Each of heart tissue anchors 264A and 264B includes a plurality of perforations 268. Protrusions 266 and perforations 268 together constitute a position fixation mechanism.
  • Heart tissue anchors 264A and 264B can slide along a longitudinal axis 270 of elastic movement provider 262.
  • the size and position of each of protrusions 266 match those of perforations 268.
  • the shape of protrusions 266 is such that the movement of heart tissue anchors 264A and 264B relative to elastic movement provider 262, is irreversible (i.e., once heart tissue anchors 264A and 264B are moved in directions designated by arrows 272A and 272B, respectively, they are locked in position, and can not move back in opposite directions).
  • each of protrusions 266 a saw-tooth form, and each of perforations 268 a compatible rectangular contour.
  • the protrusions can be formed inside each of the heart tissue anchors, and the perforations on the elastic movement provider.
  • Each of heart tissue anchors 264A and 264B can be moved relative to elastic movement provider 262, as described herein above in connection with Figure 5A, as described herein below, or by other methods known in the art.
  • Figure 7A is a schematic illustration of a bottom view of an implant, generally referenced 290, constructed and operative according to another embodiment of the disclosed technique.
  • Figure 7B is a schematic illustration of a top view of the implant of Figure 7A.
  • Figure 7C is a schematic illustration of a side view of the implant of Figure 7A.
  • Implant 290 includes an elastic movement provider 292, heart tissue anchors 294A and 294B, and a displacement reduction mechanism 296.
  • Elastic movement provider 292 includes a plurality of protrusions 298.
  • Each of heart tissue anchors 294A and 294B includes a plurality of perforations 300.
  • Protrusions 298 and perforations 300 are similar to protrusions 266 ( Figure 6C) and perforations 268, respectively.
  • Protrusions 298 and perforations 300 together constitute a position fixation mechanism similar to the position fixation mechanism described herein above in connection with Figure 6A.
  • Displacement reduction mechanism 296 includes an atemporal elastic element 302 and temporal elements 304A and 304B.
  • Atemporal elastic element 302 is coupled between heart tissue anchors 294A and 294B.
  • Temporal elastic element 304A is coupled between heart tissue anchor 294A and one end of elastic movement provider 292.
  • Temporal elastic element 304B is coupled between heart tissue anchor 294B and the other end of elastic movement provider 292. It is noted that implant 290 can be operational with only one of temporal elements 304A and 304B.
  • Atemporal elastic element 302 is made of an elastic material, whose spring constant is substantially constant over time.
  • Atemporal elastic element 302 is made of a polymer or metal spring, and the like.
  • Each of temporal elements 304A and 304B can be an elastic element whose spring constant reduces and loses potential energy (i.e., either tension or compression force) over time (i.e., each of temporal elements 304A and 304B undergoes a physical degradation).
  • each of temporal elements 304A and 304B can be made of a non-elastic element, such as a biodegradable material, and the like, which disintegrates over time (i.e., each of temporal elements 304A and 304B undergoes a biological degradation).
  • each of temporal elements 304A and 304B can include a plurality of temporal elements, each made of a biodegradable material.
  • Atemporal elastic element 302 can be a tension element (i.e., resists a tensile force applied thereto).
  • atemporal elastic element 302 applies forces (i.e., permanent forces) on heart tissue anchors 294A and 294B, to move heart tissue anchors 294A and 294B, in directions designated by arrows 306A and 306B, respectively.
  • Temporal elements 304A and 304B apply forces (i.e., temporary forces) on heart tissue anchors 294A and 294B, respectively, in directions opposite to arrows 306A and 306B, respectively.
  • atemporal elastic elements 302 can be regarded as the permanent portion of displacement reduction mechanism 296, and temporal elements 304A and 304B, as the degradable portion of displacement reduction mechanism 296.
  • each of temporal elements 304A and 304B can be made of a non-elastic element, such as a biodegradable material, and the like, which disintegrates over time.
  • each of temporal elements 304A and 304B can include a plurality of temporal elements, each made of a biodegradable material.
  • the plurality of temporal elements can include biodegradable elements of different lengths, which disintegrate sequentially, causing a gradual reduction of the displacement between heart tissue anchors 294A and 294B.
  • the disintegration rate can be controlled by employing an external energy source, which emits energy, thus causing disintegration of temporal elements 304A and 304B, by heating or by inducing an electric current, as described herein below.
  • the disintegration rate can also be controlled by employing an external energy source, which generates a mechanical wave (e.g., ultrasonic wave, shock wave), thus causing disintegration of temporal elements 304A and 304B.
  • a mechanical wave e.g., ultrasonic wave, shock wave
  • this disintegration rate can be controlled by injecting a catalyst through the vascular system of the body of the patient.
  • a temporal compressive type elastic element i.e., an elastic element which resists a compressive force applied thereto
  • two atemporal compressive elastic elements are coupled between the respective heart tissue anchor, and the respective end of the elastic movement provider.
  • the temporal compressive elastic element is an elastic element whose spring constant reduces and loses potential energy over time.
  • the implant can be devoid of the elastic movement provider.
  • the two heart tissue anchors are coupled together by a temporal element and an atemporal elastic element.
  • the atemporal elastic element is an elastic element which applies a constant force on the two heart tissue anchors, to pull the two heart tissue anchors toward each other.
  • the atemporal elastic element can be for example, in form of a tension spring, and the like.
  • the temporal element is an element which initially applies a force on the two heart tissue anchors, to force the two heart tissue anchors away from one another.
  • the temporal element can be for example, in form of a biodegradable element, a compression spring which loses the spring property thereof, over time, and the like.
  • the tension force of the atemporal elastic element acts on the two heart tissue anchors, thereby pulling the two heart tissue anchors toward one another, and reducing the antero-posterior diameter of the heart valve annulus.
  • Figure 8A is a schematic illustration of a top view of an implant, generally referenced 330, constructed and operative according to a further embodiment of the disclosed technique.
  • Figure 8B is a schematic illustration of a side view of the implant of Figure 8A.
  • Figure 8C is a schematic illustration of the implant of Figure 8A, in a contracted state.
  • Implant 330 includes heart tissue anchors 334A and 334B, a displacement reduction mechanism 336, and an energy converter 338.
  • Displacement reduction mechanism 336 is coupled between heart tissue anchors 334A and 334B.
  • Energy converter 338 is coupled with displacement reduction mechanism 336.
  • Displacement reduction mechanism 336 is an element which changes shape when the temperature thereof is changed.
  • displacement reduction mechanism 336 is an element which changes shape when an electric current flows there through.
  • Displacement reduction mechanism 336 can be for example, in form of a shape memory element, made of a shape memory alloy (SMA) such as Nitinol, and the like.
  • Energy converter 338 is an element which converts the energy emitted by an energy source (not shown) located external to the heart of the body of a patient, to heat. Alternatively, energy converter 338 is an element which converts the energy to electric current.
  • the energy source emits electromagnetic radiation (e.g., radio frequency, microwave). Alternatively, the energy source emits acoustic energy (e.g., ultrasound).
  • the energy source can be part of a medical imaging device, such a magnetic resonance imager (MRI), an MRI coil, an ultrasound probe, and the like.
  • displacement reduction mechanism 336 changes shape due to the change in temperature.
  • the change in the shape of displacement reduction mechanism 336 causes heart tissue anchors 334A and 334B to move toward one another, thereby reducing the antero-posterior diameter of a heart valve annulus.
  • energy converter 338 converts the electromagnetic radiation to an electric current
  • energy converter 338 transfers the electric current to displacement reduction mechanism 336
  • displacement reduction mechanism 336 changes shape due to the electric current flowing there through.
  • the change in the shape of displacement reduction mechanism 336 causes heart tissue anchors 334A and 334B to move toward one another, thereby reducing the antero-posterior diameter of a heart valve annulus.
  • displacement reduction mechanism 336 changes shape due to the change in temperature.
  • the change in the shape of displacement reduction mechanism 336 causes heart tissue anchors 334A and 334B to move toward one another, thereby reducing the antero-posterior diameter of a heart valve annulus.
  • the displacement reduction mechanism can be made, of a material and in a shape, which converts the energy emitted by the energy source, to heat. Further alternatively, the displacement reduction mechanism can be made of a material, which converts the energy emitted by the energy source to an electric current. Alternatively, the displacement reduction mechanism is coated with a material which converts the energy emitted by the energy source to heat. Further alternatively, the displacement reduction mechanism can be coated with a material which converts the energy emitted by the energy source to an electric current. Alternatively, the displacement reduction mechanism can be constructed from a first element which changes shape due to a change in temperature, and a second element which converts the energy emitted by the energy source to heat (i.e., the energy converter is integrated with the displacement reduction mechanism.
  • the second element can convert the energy to an electric current.
  • the energy converter can be eliminated from the implant.
  • the energy source can emit electromagnetic radiation in the range of MHz to tens of MHz
  • energy converter 338 can be a ferrite encapsulated within a biocompatible shell, wherein converter 338 converts the electromagnetic radiation to heat.
  • the energy source can generate an ultrasonic wave in the range of MHz to tens of MHz
  • energy converter 338 can be made of a material highly absorbs ultrasonic energy, such as encapsulated Hysol, wherein converter 338 converts the absorbed ultrasonic energy to heat.
  • displacement reduction mechanism 336 is bent due to the energy emitted by the external energy source.
  • the bending of displacement reduction mechanism 336 reduces the displacement between heart tissue anchors 334A and 334B. In this manner it is ensured that displacement reduction mechanism 336 does not make contact with the leaflets (not shown) of the heart valve, while displacement reduction mechanism 336 is contracted.
  • displacement reduction mechanism 336 can contract in a linear manner, to reduce the displacement between heart tissue anchors 334A and 334B.
  • displacement reduction mechanism 336 can contract in a non-linear manner, to reduce the displacement between heart tissue anchors 334A and 334B.
  • Displacement reduction mechanism 336 maintains the displacement between heart tissue anchors 334A and 334B, after moving heart tissue anchors 334A and 334B toward one another, and after the cessation of the energy emission by the energy source.
  • the energy source can be located for example, in the esophagus (transesophageal) of the body of the patient.
  • the energy source emits energy in short cycles, in order to minimize sharp changes in temperature, and injury to the tissue of the body of the patient.
  • energy converter 338 is located in such a location (for example midway between heart tissue anchors 334A and 334B), so that no damage is induced to the tissue, and the generated heat is readily dissipated by the blood flow.
  • the physician exposes implant 330 to the energy source during the heart valve implant procedure, in order to reduce the antero-posterior diameter of the heart valve of the heart of the body of the patient.
  • the physician exposes implant 330 to the energy source after completion of the heart valve implant procedure (e.g., hours, days, week, or months thereafter).
  • the procedure of reducing the displacement between heart tissue anchors 334A and 334B, as described herein above, can be performed in a single session. Alternatively, the procedure can be performed in several sessions.
  • displacement mechanism 336 can be made of a shape memory alloy which changes shape, when reaching the body temperature of the body of the patient.
  • displacement reduction mechanism 336 is maintained at a temperature lower than that of the body temperature, before anchoring implant 330 to the heart valve annulus.
  • displacement reduction mechanism 336 can be made of a shape memory alloy, which changes shape, when reaching a temperature higher than that of the body temperature.
  • displacement reduction mechanism 336 can be heated by direct contact with a heating element (not shown), during the heart valve implant procedure.
  • displacement reduction mechanism 336 can be heated by inducing an electric current there through, during the heart valve implant procedure.
  • displacement reduction mechanism 336 can be heated by direct contact with a heating element (not shown), by introducing a catheter in the left atrium, after completing the heart valve implant procedure, as described herein above.
  • displacement reduction mechanism 336 can be heated by inducing an electric current there through, by introducing a catheter in the left atrium, after completing the heart valve implant procedure, as described herein above.
  • Figure 9A is a schematic illustration of a patient, generally referenced 340, subject to an external source of energy.
  • Figure 9B is a schematic illustration of a patient, generally referenced 350, subject to an internal source of energy.
  • an external energy source 342 emits electromagnetic radiation, through a coil 344 located external to the body of patient 340.
  • external energy source 342 can be an acoustic source which emits an acoustic wave, via an acoustic probe 344, located external to the body of patient 340.
  • a plurality of probes 344 located external to the body of patient 340 can be employed to emit the energy generated by external energy source 342.
  • an external energy source 352 is coupled with a probe 354 located within the body of patient 350. Probe 354 is similar to probe 344 ( Figure 9A) as described herein above.
  • the energy source can employ a probe to direct and focus the emitted energy toward the energy converter.
  • the waveform and frequency of the energy source is selected to minimize heating and potential damage to tissue of the body of the patient.
  • Figure 10A is a schematic illustration of a bottom view of an implant, generally referenced 370, constructed and operative according to another embodiment of the disclosed technique.
  • Figure 10B is a schematic illustration of a top view of the implant of Figure 10A.
  • Figure 10C is a schematic illustration of a side view of the implant of Figure 10A.
  • Implant 370 includes an elastic movement provider 372, heart tissue anchors 374A and 374B, a displacement reduction mechanism 376, and an energy converter 378. Displacement reduction mechanism 376 and energy converter 378, are similar to displacement reduction mechanism 336 ( Figure 8A), and energy converter 338, respectively, as described herein above.
  • Elastic movement provider 372 includes a plurality of protrusions 380.
  • Each of heart tissue anchors 374A and 374B includes a plurality of perforations 382.
  • Protrusions 380 and perforations 382 are similar to protrusions 266 ( Figure 6C) and perforations 268, respectively. Protrusions 380 and perforations 382 together constitute a position fixation mechanism similar to the position fixation mechanism described herein above in connection with Figure 6A.
  • FIG. 11A is a schematic illustration of a bottom view of an implant, generally referenced 410, constructed and operative according to a further embodiment of the disclosed technique.
  • Figure 11 B is a schematic illustration of a top view of the implant of Figure 11 A.
  • Figure 11C is a schematic illustration of a side view of the implant of Figure 11A.
  • Implant 410 includes an elastic movement provider 412, heart tissue anchors 414A and 414B, a flexible connector 416, and a displacement reduction mechanism 418.
  • Flexible connector 416 can be in form of a wire, a thread, and the like.
  • Displacement reduction mechanism 418 includes one or more actuators (not shown), which provides rotary motion. Alternatively, the actuators provide linear motion.
  • Displacement reduction mechanism 418 is an element (e.g., microelectromechanical system - MEMS) whose temperature changes when subjected to an electromagnetic field (e.g., radio frequency, microwave). Displacement reduction mechanism 418 produces a mechanical motion (i.e., rotary, linear) due to this change in temperature.
  • displacement reduction mechanism 418 is an element (e.g., MEMS) which generates an electric current (e.g., Eddy currents), when subjected to the electromagnetic field.
  • Displacement reduction mechanism 418 produces a mechanical motion, due to this electric potential.
  • displacement reduction mechanism 418 produces a mechanical motion when exposed to an acoustic energy.
  • displacement reduction mechanism 418 is made for example, from a piezoelectric material.
  • Implant 410 can include a controller (not shown) to control the displacement reduction mechanism by a predetermined control signal, in order to prevent activation thereof by other signals, such as noise.
  • Displacement reduction mechanism 418 can be an element which accumulates energy.
  • Displacement reduction mechanism 418 is coupled with heart tissue anchor 414A.
  • Displacement reduction mechanism can include a pulley (not shown) mounted on a shaft thereof.
  • One end of flexible connector 416 is wound around the pulley, and another end thereof is coupled with heart tissue anchor 414B.
  • Displacement reduction mechanism 418 can include a stop (not shown), which prevents displacement reduction mechanism 418 to move in an opposite direction, once it has moved in a given direction.
  • displacement reduction mechanism 418 rotates in a direction designated by an arrow 420.
  • This rotation applies a pull on heart tissue anchor 414B via flexible connector 416, and causes heart tissue anchor 414B to move in a direction designated by an arrow 422, against the tension in the mitral valve annulus (not shown), which tends to keep the mitral valve annulus at an increased diameter.
  • the stop prevents displacement reduction mechanism 418 to rotate in a direction opposite to that of arrow 420, thereby maintaining the mitral valve annulus at the reduced diameter.
  • implant 410 can include another displacement reduction mechanism 424 similar to displacement reduction mechanism 418.
  • Displacement reduction mechanism 424 is coupled with heart tissue anchor 414B.
  • One end of flexible connector 416 is wound around the pulley of displacement reduction mechanism 418, and the other end thereof is wound around another pulley of displacement reduction mechanism 424.
  • Figure 12A is a schematic illustration of a bottom view of an implant, generally referenced 450, constructed and operative according to another embodiment of the disclosed technique.
  • Figure 12B is a schematic illustration of a top view of the implant of Figure 12A.
  • Figure 12C is a schematic illustration of a side view of the implant of Figure 12A.
  • Implant 450 includes an elastic movement provider 452, heart tissue anchors 454A and 454B, a flexible connector 456, and a displacement reduction mechanism 458.
  • Elastic movement provider 452 includes a plurality of protrusions 460.
  • Each of heart tissue anchors 454A and 454B includes a plurality of perforations 462.
  • Protrusions 460 and perforations 462 are similar to protrusions 266 ( Figure 6C) and perforations 268, respectively.
  • Protrusions 460 and perforations 462 together constitute a position fixation mechanism similar to the position fixation mechanism described herein above in connection with Figure 6A.
  • implant 450 can include a displacement reduction mechanism 464 coupled with heart tissue anchor 454B.
  • two heart tissue anchors of an implant are simultaneously anchored to a heart valve of the heart of a patient, after being deployed from a catheter which a physician passes to the heart valve region, through a blood vessel of the body of the patient. Since the implant is implanted while the heart is beating, and blood flow is intact, this simultaneous anchoring is crucial in order to perform the operation as quickly as possible, and to interrupt the normal function of the heart as little as possible.
  • the length of the implant according to one aspect of the disclosed technique is reduced only once, after being implanted. Alternatively, the length of the implant according to another aspect of the disclosed technique, can be reduced multiple times after being implanted.
  • This option allows the physician to reduce the heart valve annulus diameter, at selected intervals after the implant, according to the physical condition of the patient. In this manner, the physician ensures that the heart properly adjusts to the desired diameter of the heart valve annulus, and furthermore, preventing rupture of the heart valve annulus, which can occur due to sudden reduction in the heart valve annulus diameter.
  • Figure 13A is a schematic illustration of a system generally referenced 540, for deploying an implant from a sheath, to be implanted on a heart valve annulus, constructed and operative according to a further embodiment of the disclosed technique, the implant being in a stowed position within the sheath.
  • Figure 13B is a schematic illustration of the implant of Figure 13A, while being deployed.
  • Figure 13C is a schematic illustration of the implant of Figure 13A, while being deployed.
  • Figure 13D is a schematic illustration of a system generally referenced 541 , for deploying an implant from a sheath, to be implanted on a heart valve annulus, constructed and operative according to another embodiment of the disclosed technique, the implant being in a stowed position within the sheath.
  • Figure 13E is a schematic illustration of the implant of Figure 13D, while being deployed.
  • System 540 includes a catheter 542, a sheath 544, and an implant 546.
  • Implant 546 is similar for example, to either of implants 130 or 160, as described herein above in connection with Figures 2A and 3A, respectively, as well other implants as described herein above.
  • Implant 546 includes an anterior heart tissue anchor 548A and a posterior heart tissue anchor 548B, and an elastic movement provider 550.
  • Each of anterior heart tissue anchor 548A and posterior heart tissue anchor 548B includes a set of anchors 552.
  • Anterior heart tissue anchor 548A is coupled with one end of elastic movement provider 550.
  • Posterior heart tissue anchor 548B is coupled with another end of elastic movement provider 550.
  • Catheter 542 is located within sheath 544, and can freely move back and forth through sheath 544.
  • Sheath 544 is made of a rigid material. Alternatively, sheath 544 is made of a flexible material. Alternatively, a proximal section of sheath 544 is substantially rigid and a distal end thereof is substantially flexible. Further alternatively, sheath 544 is originally in a flexible form, and then changes to a more rigid form, for example, by employing a mechanism similar to articulating arm Estech (not shown), and the like.
  • Elastic movement provider 550 is made of a material, which can reversibly bend about an axis perpendicular to a longitudinal axis (not shown) thereof. Elastic movement provider 550 can be made of an elastic material, such as metal leaf spring, polymer, shape memory alloy (e.g., Nitinol), and the like.
  • elastic movement provider 550 is bent over a tip 554 of catheter 542, within sheath 544, in a folded configuration.
  • Elastic movement provider 550 is reversibly coupled with tip 554 of catheter 542, for example by a screw thread (not shown), and the like. Due to a bending moment which acts in elastic movement provider 550, heart tissue anchors 548A and 548B apply forces in directions designated by arrows 556A and 556B on an inner wall of sheath 544. These forces are resisted by the inner wall of sheath 544. In this manner, implant 546 is stowed within sheath 544.
  • the elastic movement provider can be kept in the folded configuration within the sheath, by employing a restraining device, for example, a thread, a clamp, and the like.
  • the physician can release the restraining device to move the elastic movement provider from the folded configuration, to a deployment configuration, out of the sheath.
  • implant 546 can include in addition, a first hinge 560A, a second hinge 560B, a first elastic element (not shown) and a second elastic element (not shown).
  • Anterior heart tissue anchor 548A can rotate by approximately ninety degrees on first hinge 560A, about a first axis (not shown) perpendicular to a longitudinal axis 562, wherein the first axis is perpendicular to the sheet of Figure 2A.
  • posterior heart tissue anchor 548B can rotate by approximately ninety degrees on second hinge 560B, about a second axis (not shown) perpendicular to longitudinal axis 562, wherein the second axis is perpendicular to the sheet of Figure 2A.
  • the first elastic element and the second elastic element are coupled with first hinge 560A and with second hinge 560B, respectively.
  • anterior heart tissue anchors 548A and posterior heart tissue anchor 548B are rotated about first hinge 560A and 560B, respectively, against the elastic force of the first elastic element and the second elastic element, respectively, while implant 546 is stowed within sheath 544, such that length dimensions L 1 ( Figure 2A) and L 2 of heart tissue anchors 548A and 548B, respectively, are substantially parallel with longitudinal axis 562.
  • anterior heart tissue anchors 548A and posterior heart tissue anchor 548B turn by approximately ninety degrees about first hinge 560A and second hinge 560B, to the state illustrated in Figure 2A. This option allows the physician to stow implant 546 within sheath 544, in a more compact configuration.
  • implant 546 moves from the folded configuration to a deployment configuration, to deploy completely to an angle between 120 and 240 degrees, in order to match the inner contour of the heart (the atrial wall, the heart valve annulus and the leaflets). This movement also deploys anchors 552 to penetrate the tissue of the heart valve annulus, simultaneously.
  • a system similar to system 540 ( Figure 13A) is employed to anchor two heart tissue anchors of a heart valve implant, to a heart valve annulus of a heart valve, and to reduce the antero-posterior diameter of the heart valve annulus, by applying forces to the two heart tissue anchors, in such directions, that minimal injury is imparted to the heart valve annulus.
  • the expander moves the heart valve implant from the folded configuration to the deployment, out of the sheath, the expander applies a first force to each heart tissue anchor, against the heart valve annulus, in a first direction substantially normal to a surface of the heart valve annulus. This first force anchors each of the heart tissue anchors to the heart valve annulus.
  • the physician applies a second force on each of the heart tissue anchors, by employing the displacement reduction mechanism, to move the two heart tissue anchors toward one another.
  • the second force is applied in a direction (i.e., a second direction), toward a center of the heart valve annulus, and away from the first direction and a tangent to the surface of the heart valve annulus.
  • the vectorial sum of the first force and the second force i.e., a third force
  • the physician reduces the probability of detachment of the heart tissue anchors from the heart valve annulus, and minimizes the probability of tissue rupture during the procedure of reducing the antero-posterior diameter of the heart valve annulus.
  • system 541 includes a catheter 543, a sheath 545, and an implant 547.
  • Implant 547 is similar to implant 546 as described herein above.
  • Implant 547 includes a first heart tissue anchor 549A 1 a second heart tissue anchor 549B, and an elastic movement provider 551.
  • Each of first heart tissue anchor 549A and second heart tissue anchor 549B includes a set of anchors (not shown).
  • First heart tissue anchor 549A and second heart tissue anchor 549B are coupled with the two ends of elastic movement provider 551 , and can slide relative to elastic movement provider 551 , toward one another.
  • Catheter 543 is located within sheath 545, and can freely move back and forth through sheath 545.
  • Elastic movement provider 551 includes two wings 559A and 559B of different lengths. Wing 559A is longer than wing 559B enabling to position heart tissue anchor 549A further away from the distal end of catheter 543 than heart tissue anchor 549B. Relative to the configuration illustrated in Figure 13A, this configuration enables to increase the size of each of heart tissue anchor 549A and 549B for the same lumen diameter of sheath 545. Alternately, wing 559A is shorter wing 559B. Although, the deployment of heart tissue anchor 549A and 549B is quasi-simultaneous, their positioning and attachment can be simultaneous according to the techniques illustrated below herein.
  • Figure 14A is a schematic illustration of the implant of Figure 13A, in a deployed position, while being located within a left atrium of the heart of a patient by percutaneous transluminal catheter delivery.
  • Figure 14B is a schematic illustration of the implant of Figure 13B in a deployed position, while being located within the left atrium.
  • Figure 14C is a schematic illustration of the implant of Figure 13C, while being anchored to a mitral valve annulus of the heart, and still engaged with the catheter.
  • Figure 14D is a schematic illustration of the implant of Figure 14C, being permanently anchored to the mitral valve annulus and disengaged from the catheter.
  • catheter 542 is located within a left atrium 566 of a heart 568 of the body of a patient (not shown), and implant 546 is stowed within sheath 544 ( Figure 13A).
  • Catheter 542 can be delivered to a right atrium (not shown) of heart 568, for example, by being introduced into the venous system (not shown) of the body of the patient, either through the jugular vein via the superior vena cava and then into the right atrium, or through the femoral vein via the inferior vena cava into the right atrium.
  • catheter 542 is introduced from the right atrium into left atrium 566 trans-septally via a septum 578 which separates the right atrium and left atrium 566.
  • trans-septal introduction of catheter 542 is known in the art, and used for other medical procedures as well.
  • Catheter 542 can be delivered through sheath 544 ( Figure 13A).
  • the usage of sheath 544 provides a tunnel for delivery of catheter 542.
  • Sheath 544 is made of a rigid material.
  • sheath 544 is made of a flexible material.
  • the proximal portion of sheath 544 is substantially rigid and a distal end thereof is substantially flexible.
  • the rigid portion of sheath 544 provides the counterforce force necessary to transform the force exerted by the physician at a proximal end of catheter 542, to a force in the appropriate direction, in order to force the implant 546 against the mitral valve annulus.
  • sheath 544 is originally in a flexible form, and then changes to a more rigid form, for example, by employing a mechanism similar to articulating arm Estech (not shown), and the like.
  • Catheter 542 is then maneuvered to substantially point towards the center of the mitral valve, and then rotated to ensure that in its deployed state the long dimension of implant 546 is substantially parallel to the antero-posterior axis of a mitral valve annulus 570 of heart 568.
  • implant 546 is deployed from sheath 544, and still coupled with catheter 542 at tip 554 thereof.
  • the long dimension of implant 546 is substantially parallel to the antero-posterior axis of a mitral valve annulus 570 of heart 568.
  • the deployment force which springs open implant 546 simultaneously anchors both heart tissue anchors 548A and 548B to mitral valve annulus 570.
  • a displacement reduction mechanism 572 moves heart tissue anchors 548A and 548B toward one another, thereby reducing the antero-posterior diameter of mitral valve annulus 570.
  • the physician can disengage implant 546 from catheter 542, for example, by unscrewing the screw thread located at tip 554 of catheter 542.
  • the reduction of the antero-posterior diameter of mitral valve annulus 570 brings about improved coaptation of mitral valve leaflets of heart 568, and reshaping of a left ventricle 574 of heart 568.
  • Reduction of the antero-posterior diameter of mitral valve annulus 570 also reduces the volume of a left ventricle 574 of heart 568, in order to treat for example, congestive heart failure.
  • the entire procedure i.e., delivery and deployment of the catheter, anchoring and reduction of the mitral valve annulus diameter
  • can be performed with the assistance of medical imaging device such as an external ultrasound imager, transesophageal ultrasound imager, and the like.
  • Displacement reduction mechanism 572 can be constructed as described herein above.
  • the antero-posterior diameter can be reduced a multiple number of times, after anchoring implant 546 to mitral valve annulus, as described herein above.
  • the reduction of antero-posterior diameter of the mitral valve can be performed either before or after disengaging implant 546 from catheter 542.
  • the physician can deliver implant 546 to left atrium 566, in a minimal invasive procedure.
  • the physician can implant heart valve implant 546 intra-operatively by puncturing the free wall of left atrium 566.
  • the physician can place a purse-string stitch on the left atrial wall around the place of insertion, in order to prevent bleeding during the insertion of implant 546.
  • the physician can perform this operation by employing either a minimal invasive method, or totally endoscopycally through the right pleural space with a thoracoscope and manipulators.
  • the physician can perform this procedure either with or without cardiopulmonary bypass, through midstemotomy.
  • the entire procedure i.e., delivery and deployment of the catheter, anchoring, and reduction of the mitral valve annulus diameter
  • a medical imaging device such as an external ultrasound imager, transesophageal ultrasound imager, and the like.
  • the physician can deliver implant 546 through a surgical procedure. The physician can perform this procedure either with or without cardiopulmonary bypass, through midsternotomy.
  • the physician can deliver and deploy the implant in several steps.
  • the physician delivers and deploys the first heart tissue anchor, positions, and then anchors the anterior heart tissue anchor on the anterior side of the mitral valve annulus.
  • the physician delivers and deploys the second heart tissue anchor, and then positions and anchors the second heart tissue anchor to the mitral valve annulus, opposite the first heart tissue anchor such the axis connecting the first and the second heart tissue anchors is substantially parallel with the antero-posterior axis of the mitral valve annulus.
  • Figure 15A is a schematic illustration of a system generally referenced 590, for deploying an implant from a sheath, to be implanted on a heart valve annulus of the heart of a patient, constructed and operative according to a further embodiment of the disclosed technique, the implant being in a stowed position within the sheath.
  • Figure 15B is a schematic illustration of the implant of Figure 15A, while being deployed.
  • Figure 15C is a schematic illustration of the implant of Figures 15A and 15B.
  • System 590 includes a catheter 592, a sheath 594, and an implant 596.
  • Implant 596 includes heart tissue anchors 598A and 598B, and an elastic movement provider 600.
  • Implant 596 can be deployed in a manner similar to the one described herein above in connection with Figures 13A 1 13B, and 13C.
  • Each of heart tissue anchors 598A and 598B is made of a self-expandable wire mesh, made of a material which expands as a result of a change in temperature, such as Nitinol, and the like.
  • Heart tissue anchors 598A and 598B are coupled with elastic movement provider 600 by a plurality of elastic connectors 602A and 602B, respectively.
  • Each of elastic connectors is in form of a wire made from an elastic material, such as polymer, elastic metal, and the like.
  • Implant 620 includes heart tissue anchors 622A and 622B, an elastic movement provider 624, and a plurality of elastic connectors 626A and 626B.
  • Each of heart tissue anchors 622A and 622B is made of a flexible material which includes a plurality of self-expandable wires 628A and 628B.
  • Self-expandable wires 628A and 628B are made of a material which can expand when subjected to a change in temperature, such as Nitinol, and the like.
  • Heart tissue anchors 622A and 622B are coupled with elastic movement provider 624, by elastic connectors 626A and 626B, respectively.
  • FIG 17 is a schematic illustration of an implant generally referenced 650, constructed and operative according to a further embodiment of the disclosed technique.
  • Implant 650 includes heart tissue anchors 652A and 652B, an elastic movement provider 654, and a plurality of elastic connectors 656A and 656B.
  • Each of heart tissue anchors 652A and 652B is made of a flexible material, such as a polymer, and the like.
  • Each of elastic connectors 656A and 656B is made of an elastic material, such as polymer, metal wire spring, and the like.
  • Heart tissue anchors 652A and 652B are coupled with elastic movement provider 654, by elastic connectors 656A and 656B, respectively. While implant 650 is delivered by a catheter (not shown) to a region of a heart valve annulus (not shown) of the heart of a patient, implant 650 is stowed within a sheath of the catheter. When implant 650 exits the sheath and springs open, elastic connectors 656A and 656B spring open too, thereby spreading open each of heart tissue anchors 652A and 652B, in order to be anchored simultaneously to the heart valve annulus of the heart.
  • Figure 18A is a schematic illustration of a system generally referenced 680, for deploying an implant from a sheath, constructed and operative according to another embodiment of the disclosed technique, the implant being stowed within the sheath.
  • Figure 18B is a schematic illustration of the implant of Figure 18A, in a deployed position.
  • System 680 includes a catheter 682, a sheath 684, an implant 686, and an expander 688.
  • Implant 686 includes heart tissue anchors 690A and 690B, and an elastic movement provider 692.
  • Catheter 682, sheath 684, and implant 686 are similar to catheter 542 ( Figure 13A), sheath 544, and implant 546, as described herein above.
  • expander 688 is in form of a balloon. Balloon 688 is located at a distal end 694 of catheter 682.
  • implant 686 is stowed within sheath 684, with elastic movement provider 692 bent over distal end 694, and heart tissue anchors 690A and 690B located between the periphery of balloon 688 and an inner wall of sheath 684.
  • the physician withdraws sheath 684, thereby exposing balloon 688, and inflates balloon 688.
  • Balloon 688 expands and forces implant 692 open against a heart valve annulus (not shown) of the heart of the patient, thereby simultaneously anchoring heart tissue anchors 690A and 690B, to the heart valve annulus.
  • the physician can inflate balloon 688 until balloon 688 occupies the entire volume of the left atrium of the heart of the patient.
  • implant 692 can include a stop (not shown) coupled with elastic movement provider, in order to prevent return of implant 692 from the deployed position toward the stowed position. It is noted that the physician employs system 680 while the heart of the body of the patient is beating and blood flow in the heart is intact. Hence, balloon 688 and accompanying elements, such as a remote inflating device (not shown), have to be constructed in such a manner that rapid inflation and deflation is ensured. This is necessary in order to incur least damage to the heart.
  • Figure 19A is a schematic illustration of a system generally referenced 720, for deploying an implant from a sheath, constructed and operative according to a further embodiment of the disclosed technique, the implant being stowed within the sheath.
  • Figure 19B is a schematic illustration of the implant of Figure 19A, in a deployed position.
  • System 720 includes a catheter 722, a sheath 724, an implant 726, and an expander 728.
  • Implant 726 includes heart tissue anchors 730A and 730B, and an elastic movement provider 732.
  • Catheter 722, sheath 724, and implant 726 are similar to catheter 542 ( Figure 13A), sheath 544, and implant 546, as described herein above.
  • expander 728 can be in form of a shape memory alloy, such as Nitinol, and the like, which expands (i.e., the volume thereof increases), when subjected to a change in temperature. Expander 728 is located at a distal end 734 of catheter 722. Except the type of the expander, system 720 is similar to system 680 ( Figures 18A and 18B) as described herein above.
  • Figure 2OA is a schematic illustration of a system generally referenced 760, for deploying an implant from a sheath, constructed and operative according to another embodiment of the disclosed technique, the implant being stowed within the sheath.
  • Figure 2OB is a schematic illustration of the implant of Figure 2OA, in a deployed position.
  • System 760 includes a catheter 762, a sheath 764, an implant 766, and an expander 768.
  • Implant 766 includes heart tissue anchors 770A and 770B, and an elastic movement provider 772.
  • Catheter 762, sheath 764, and implant 766 are similar to catheter 542 ( Figure 13A), sheath 544, and implant 546, as described herein above.
  • expander 768 includes a plurality of elastic elements 774A and 774B, such as leaf springs made from a sheet metal, polymer, and the like (i.e., an elastic material). Expander 768 is located at a distal end 776 of catheter 762, and coupled therewith.
  • heart tissue anchors 770A and 770B are located between the tips of the leaf springs (i.e., expander 768), and the inner wall of sheath 764.
  • expander 768 is in a compressed state.
  • elastic elements 774A and 774B i.e., the leaf springs
  • FIG 21 is a schematic illustration of a method for reducing the antero-posterior diameter of heart valve annulus of a malfunctioning heart valve of the heart of the body of a patient, operative according to a further embodiment of the disclosed technique.
  • a heart valve implant is delivered to a malfunctioning heart valve of the heart of the body of the patient.
  • the physician delivers implant 546 to left atrium 566, via catheter 542, for implanting on mitral valve annulus 570 of heart 568 of the patient.
  • an anterior heart tissue anchor of the heart valve implant is anchored to an anterior region of the heart valve annulus of the malfunctioning heart valve.
  • heart tissue anchor 548A is anchored to an anterior region of mitral valve annulus 570.
  • a posterior heart tissue anchor of the heart valve implant is anchored to a posterior region of the heart valve annulus of the malfunctioning heart valve.
  • heart tissue anchor 548B is anchored to a posterior region of mitral valve annulus 570.
  • the displacement between the anterior heart tissue anchor and the posterior heart tissue anchor is reduced, by exposing the heart valve implant to an energy source, to move the anterior heart tissue anchor and the posterior heart tissue anchor, toward one another, wherein the energy source is located external to the heart of the body of the patient.
  • energy converter 338 converts this energy to heat, and this heat causes a reduction in the length of displacement reduction mechanism 336.
  • This reduction in length moves heart tissue anchors 334A and 334B toward one another, thereby reducing the antero-posterior diameter of a mitral valve annulus (not shown), on which implant 330 is implanted.
  • the physician can repeat procedure 806 any number of times, in order to ensure proper adjustment of the heart to implant 546, and furthermore, to decrease the probability of ruptures in the anchoring region of mitral valve annulus 570, by allowing sufficient time for the mitral valve tissue to heal and grow.

Abstract

Device for reducing the antero posterior diameter of a heart valve annulus of a heart valve of the heart of the body of a patient, the device including at least one anterior heart tissue anchor, to be anchored to an anterior region of the heart valve annulus, at least one posterior heart tissue anchor, to be anchored to a posterior region of the heart valve annulus, and a displacement reduction mechanism, coupled with the anterior heart tissue anchor and with the posterior heart tissue anchor, the displacement reduction mechanism moving at least one of the anterior heart tissue anchor and the posterior heart tissue anchor, toward one another, when the displacement reduction mechanism is exposed to an energy emitted by an energy source located external to the heart.

Description

METHOD AND DEVICE FOR TREATMENT OF CONGESTIVE HEART
FAILURE AND VALVE DYSFUNCTION
FIELD OF THE DISCLOSED TECHNIQUE
The disclosed technique relates to devices and methods for mitral valve repair and treatment of congestive heart failure, in general, and to devices and methods for reshaping the mitral valve annulus, or similar anatomical structures, in particular.
BACKGROUND OF THE DISCLOSED TECHNIQUE
Five million people in the US are afflicted with congestive heart failure with approximately 500,000 new cases diagnosed every year. This progressive disease causes degradation of the ability of the heart to pump oxygenated blood through the body, and eventually leading to the death of the patient within a few years after the diagnosis.
One of the most prevalent forms of heart failure is cardiomyopathy in which the left ventricle and the annulus of the mitral valve, are gradually dilated and the ventricular contraction becomes less efficient. The dilatation of the left ventricle and mitral valve annulus reduces coaptation of the leaflets of the mitral valve, thus bringing about valve regurgitation.
Surgical treatment of the mitral valve or restoration of the dilated mitral valve annulus, especially reduction of the antero-posterior diameter, improves the condition of patients suffering from heart failure, reduces utilization of healthcare services, and increases their survival expectancy. Such a procedure involves reduction of annular size by implantation of a prosthetic ring. This procedure restores the normal shape and size of the left ventricles, improves mitral valve leaflets coaptation, and eliminates mitral regurgitation. Such a procedure requires open-heart surgery and entails high mortality, due to poor medical condition of the patient. Therefore, this procedure is beneficial only to a small group of patients.
An implant can be delivered via a catheter to the left atrium or the left ventricle, in order to reshape the mitral valve or the left ventricle. The implant is anchored across the mitral valve, in adjacent anatomical structures (e.g., in the coronary sinus), or across the heart chamber. The implant shrinks or reshapes the mitral valve annulus, or the heart chamber. Such a procedure requires anchoring of the implant in order to ensure that it remains attached to the tissue to which it was originally anchored. This procedure is similar to surgical ring annuloplasty.
US Patent No. 6,626,930 B1 issued to Allen et al., and entitled "Minimally Invasive Mitral Valve Repair Method and Apparatus", is directed to a system for repairing a mitral valve of a heart. The system includes a catheter tube and a vacuum source. The catheter tube includes a pair of vacuum ports which are connected to the vacuum source. The catheter tube includes two needles located within the vacuum ports, at a flat distal end of the catheter tube. Each of the needles includes a toggle and a pusher. Each of the toggles is connected to a suture thread. A user maneuvers the catheter tube to an opening of the mitral valve, and pushes the needles so that the sharp ends of the needles pierce the leaflets of the mitral valve. The user displaces the toggles, in order to anchor the ventricular side of the leaflets. The user ties off the suture threads on the atrial side, to secure the leaflets.
US Patent No. 6,485,489 B2 issued to Teirstein et al., and entitled "Catheter System for Repairing a Mitral Valve Annulus", is directed to a catheter system for compressively sandwiching the inner wall of an annular organ structure of a heart valve. The catheter system includes a tissue contactor deployment mechanism, an electrode deployment means, a catheter shaft, a high frequency current generator, a plurality of needle electrodes, a tissue contactor member, and a handle. The tissue contactor member includes a plurality of internal channels. The handle includes a steering mechanism.
The handle is located at a proximal end of the catheter shaft. The tissue contactor deployment mechanism and the electrode deployment means are located at the handle. In a stowed state, the tissue contactor member is located at a distal end of the catheter shaft, within a lumen of the catheter shaft. The needle electrodes are connected to the high frequency current generator. The tissue contactor member is connected to the tissue contactor deployment mechanism. A user percutaneously maneuvers the tip of the catheter shaft through a blood vessel of a patient, toward a site of the heart valve, by manipulating the steering mechanism. The user deploys the tissue contactor member out of the lumen of the catheter shaft, by employing the tissue contactor deployment mechanism. The user advances the needle electrodes out of the lumen of the catheter shaft, through the internal channels, by employing the electrode deployment means. The user activates the high frequency current generator, to provide high frequency heat to the collagen of the tissue of the annular organ structure, via the needle electrodes. . US Patent No. 7,004,958 B2 issued to Adams et al., and entitled
"Transvenous Staples, Assembly and Method for Mitral Valve Repair", is directed to a mitral valve therapy staple device, for repairing a mitral valve of a heart. The staple device is located within a deployment catheter. The staple device includes a first and a second tissue piercing leg portions, and a connection portion. The connection portion has an arcuate configuration, and is located between the first and second tissue piercing leg portions. The first and second tissue piercing leg portions terminate at a first and a second piercing ends, respectively. The deployment catheter includes a tubular wall in which a slot is formed. The staple device is located within the deployment catheter, adjacent the slot. The deployment catheter includes a tool, for forcing the staple device out through the slot. The staple device is made of a shape memory material.
A user positions the deployment catheter within the coronary sinus adjacent the mitral valve, and inflates an inflatable balloon, to urge the deployment catheter against the wall of the coronary sinus. The user forces the staple device out of the slot, by employing the tool. The first and second tissue piercing leg portions pierce the mitral valve annulus, and transform from an initial configuration to a final configuration. In this final configuration, the staple device tightens the mitral valve annulus, thereby terminating mitral valve regurgitation. The radius of curvature of the mitral valve annulus in the final configuration is much larger than in the case of the initial configuration.
US Patent No. 7,052,487 B2 issued to Cohn et al., and entitled "Method and Apparatus for Reducing Mitral Regurgitation", is directed to a system which reduces mitral regurgitation by forcing the posterior annulus of a mitral valve anteriorly. The system includes a guidewire, a delivery catheter, and a push rod. The delivery catheter includes an adjustable valve and a balloon. The push rod includes a rigid elongated body and a removable proximal stiffener. The rigid elongated body is located proximal to a distal end of the push rod. The removable proximal stiffener is located between the rigid elongated body and a proximal end of the push rod.
A user maneuvers the guidewire to a coronary sinus of the heart of a patient. The user passes the delivery catheter down the guidewire, until the distal end of the delivery catheter is positioned at the coronary sinus. Due to its flexible nature, the delivery catheter assumes the curvature of the coronary sinus. The user removes the guidewire, and inflates the balloon, in order to secure the distal end of the delivery catheter within the coronary sinus.
The user passes the push rod through a central lumen of the delivery catheter, until the rigid elongated body is located adjacent the posterior annulus of the mitral valve, by employing the removable proximal stiffener. The presence of the rigid elongated body causes a portion of the coronary sinus to assume a straight configuration, so that the posterior annulus of the mitral valve is force anteriorly, to improve mitral valve leaflet coaptation, and reduce mitral valve regurgitation. US Patent No. 5,201,880 issued to Wright et al., and entitled
"Mitral and Tricuspid Annuloplasty", is directed to a method to minimize valvular insufficiency following implantation of a ring, which was previously performed to reduce valve regurgitation. A user passes two drawstrings through loops within the ring, and tightens the external portions of the drawstrings, to constrict the ring, and to correct the valvular insufficiency.
US Patent application No. 2005/0143811 issued to Realyvasquez, and entitled "Methods and Apparatus for Mitral Valve Repair", is directed to a device for percutaneous mitral valve repair. The device includes a plurality of wired stents, a plurality of trans-vascular delivered fasteners and a ratchet mechanism. The wired stents are connected with the ratchet mechanism to form a V shape device, wherein one of the wired stents forms a posterior leg and another wired stent forms an anterior leg. Each of the wired stents includes a plurality of tines located at the ends opposite to the ratchet mechanism. The device is delivered to the heart of a patient using a percutaneous intravascular catheter. Once the percutaneous intravascular catheter is delivered to the heart through the inter-atrial septum, the two wired stents are deployed. The anterior leg and the posterior leg are attached to the anterior part and the posterior part of the mitral valve annulus, respectively, by the tines which are located at each end of the anterior part and the posterior part. The attachment of the anterior leg and the posterior leg to the mitral valve annulus, is a temporary one. When the physician determines that each of the wired stents is in the proper position, the trans-vascular delivered fasteners permanently anchor the wired stents to the mitral valve annulus. After the device has been anchored, using the trans-vascular delivered fasteners, the physician rotates the catheter in a counterclockwise direction, in order to activate the ratchet mechanism. The ratchet mechanism reduces the dimension between the wired stents, in order to achieve mitral valve competence.
US Patent Application No. 2004/0260393 A1 to Rahdert et al., and entitled "Devices, Systems, and Methods for Reshaping a Heart Valve Annulus", is directed to an implant for shortening the antero-posterior axis of the mitral valve of the heart of a patient. The implant includes a pair of struts and an intermediate rail. The struts are connected to the intermediate rail at opposite ends of the rail. Each strut includes an array of tissue penetrating barbs. The implant is made of an elastic material and is in a relaxed position when it is being implanted. The struts are spaced apart closer than the antero-posterior dimension of the targeted heart valve annulus.
The implant is delivered by a catheter, via the femoral vain or artery. The implant is constrained in a straightened position within the sheath of the catheter. Initially, a physician frees the strut of the posterior end from the sheath, and manipulates the strut to the posterior side of the annulus. The physician anchors the posterior end of the strut to the posterior side of the annulus by employing the tissue penetrating barbs. The physician uses a balloon to place the rail in tension and to seat the anterior end of the strut at the anterior side of the annulus. The physician anchors the anterior end of the strut to the anterior side of the annulus by employing the tissue penetrating barbs. The tension in the rail pulls both ends of the strut inwardly to shorten the antero-posterior axis of mitral valve annulus.
US Patent No. 6,997,951 B2 issued to Solem et al., and entitled "Method and Device for Treatment of Mitral Valve Insufficiency", is directed to a device for reduction of the mitral valve annulus using a catheter based technology. The device includes a proximal stent section, a distal stent section, a central stent section and a biodegradable structure. The central stent section is connected between the proximal section and with the distal section. The biodegradable structure is disposed on the central section. The central section is capable to decrease its length. The biodegradable structure keeps the central section in tension, so that the central stent section maintains its original length. The device has a contracted delivery configuration, wherein the device is radially stowed within a delivery sheath of a catheter. After the deployment of the device at the coronary sinus of the heart of a patient, the proximal and distal sections of the device radially expand to be engaged with a blood vessel wall of the patient. Over the course of several weeks or months, the proximal and distal sections are biologically anchored to the blood vessel wall. When the proximal and distal sections are anchored, the biodegradable structure disintegrates. As a result, the tension in the central stent section is relieved, and the central stent section transforms to its shorter length, and draws the proximal and distal sections close to one another. The force created by the central stent section remodels the mitral valve annulus.
BRIEF DESCRIPTION OF THE DRAWINGS
The disclosed technique will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which:
Figure 1 is a schematic illustration of a cross section of a heart whose mitral valve annulus and left ventricle are dilated;
Figure 2A is a schematic illustration of a top view of an implant to be attached to the mitral valve annulus of the heart of Figure 1 , in order to reduce the antero-posterior diameter of the mitral valve annulus and the volume of the left ventricle of the heart of Figure 1 ;
Figure 2B is a schematic illustration of a side view of the implant of Figure 2A;
Figure 3A is a schematic illustration of a top view of an implant, constructed and operative according to an embodiment of the disclosed technique, to be attached to the mitral valve annulus of the heart of Figure
1 , in order to reduce the antero-posterior diameter of the mitral valve annulus and the volume of the left ventricle of the heart of Figure 1 ;
Figure 3B is a schematic illustration of a side view of the implant of Figure 3A;
Figure 4A is a schematic illustration of a male portion of the heart tissue anchor assembly of the implant of Figure 3B;
Figure 4B is a schematic illustration of a female portion of the heart tissue anchor assembly of Figure 3B; Figure 4C is a schematic illustration of a perspective exploded view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively;
Figure 4D is a schematic illustration of a perspective view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively, during engagement; Figure 4E is a schematic illustration of a perspective view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively, after engagement;
Figure 5A is a schematic illustration of an implant, attached to the mitral valve annulus of Figure 1 , prior to decrease in the opening of the mitral valve annulus, and constructed and operative according to another embodiment of the disclosed technique;
Figure 5B is a schematic illustration of the implant of Figure 5A, after reducing the opening of the mitral valve annulus; Figure 6A is a schematic illustration of a bottom view of an implant, generally referenced 260, constructed and operative according to a further embodiment of the disclosed technique;
Figure 6B is a schematic illustration of a top view of the implant of Figure 6A. Figure 6C is a schematic illustration of a side view of the implant of Figure 6A;
Figure 7A is a schematic illustration of a bottom view of an implant, constructed and operative according to another embodiment of the disclosed technique;
Figure 7B is a schematic illustration of a top view of the implant of Figure 7A;
Figure 7C is a schematic illustration of a side view of the implant of Figure 7A;
Figure 8A is a schematic illustration of a top view of an implant, constructed and operative according to a further embodiment of the disclosed technique;
Figure 8B is a schematic illustration of a side view of the implant of Figure 8A;
Figure 8C is a schematic illustration of the implant of Figure 8A, in a contracted state; Figure 9A is a schematic illustration of a patient, subject to an external source of energy; Figure 9B is a schematic illustration of a patient, subject to an internal source of energy;
Figure 1OA is a schematic illustration of a bottom view of an implant, constructed and operative according to another embodiment of the disclosed technique;
Figure 1OB is a schematic illustration of a top view of the implant of Figure 10A;
Figure 10C is a schematic illustration of a side view of the implant of Figure 10A; Figure 11A is a schematic illustration of a bottom view of an implant, constructed and operative according to a further embodiment of the disclosed technique;
Figure 11 B is a schematic illustration of a top view of the implant of Figure 11 A; Figure 11C is a schematic illustration of a side view of the implant of Figure 11 A;
Figure 12A is a schematic illustration of a bottom view of an implant, constructed and operative according to another embodiment of the disclosed technique; Figure 12B is a schematic illustration of a top view of the implant of Figure 12A;
Figure 12C is a schematic illustration of a side view of the implant of Figure 12A;
Figure 13A is a schematic illustration of a system for deploying an implant from a sheath, to be implanted on a heart valve annulus, constructed and operative according to a further embodiment of the disclosed technique, the implant being in a stowed position within the sheath;
Figure 13B is a schematic illustration of the implant of Figure 13A, while being deployed; Figure 13C is a schematic illustration of the implant of Figure 13A, while being deployed;
Figure 13D is a schematic illustration of a system for deploying an implant from a sheath, to be implanted on a heart valve annulus, constructed and operative according to another embodiment of the disclosed technique, the implant being in a stowed position within the sheath;
Figure 13E is a schematic illustration of the implant of Figure 13D, while being deployed; Figure 14A is a schematic illustration of the implant of Figure
13A, in a deployed position, while being located within a left atrium of the heart of a patient by percutaneous transluminal catheter delivery;
Figure 14B is a schematic illustration of the implant of Figure 13B in a deployed position, while being located within the left atrium; Figure 14C is a schematic illustration of the implant of Figure
13C, while being anchored to a mitral valve annulus of the heart, and still engaged with the catheter;
Figure 14D is a schematic illustration of the implant of Figure 14C, being permanently anchored to the mitral valve annulus and disengaged from the catheter;
Figure 15A is a schematic illustration of a system for deploying an implant from a sheath, to be implanted on a heart valve annulus of the heart of a patient, constructed and operative according to a further embodiment of the disclosed technique, the implant being in a stowed position within the sheath;
Figure 15B is a schematic illustration of the implant of Figure 15A, while being deployed;
Figure 15C is a schematic illustration of the implant of Figures 15A and 15B; Figure 16 which is a schematic illustration of an implant constructed and operative according to another embodiment of the disclosed technique;
Figure 17 which is a schematic illustration of an implant constructed and operative according to a further embodiment of the disclosed technique;
Figure 18A is a schematic illustration of a system for deploying an implant from a sheath, constructed and operative according to another embodiment of the disclosed technique, the implant being stowed within the sheath;
Figure 18B is a schematic illustration of the implant of Figure 18A, in a deployed position;
Figure 19A is a schematic illustration of a system for deploying an implant from a sheath, constructed and operative according to a further embodiment of the disclosed technique, the implant being stowed within the sheath;
Figure 19B is a schematic illustration of the implant of Figure 19A, in a deployed position;
Figure 2OA is a schematic illustration of a system for deploying an implant from a sheath, constructed and operative according to another embodiment of the disclosed technique, the implant being stowed within the sheath;
Figure 2OB is a schematic illustration of the implant of Figure 2OA, in a deployed position; and Figure 21 is a schematic illustration of a method for reducing the antero-posterior diameter of heart valve annulus of a malfunctioning heart valve of the heart of the body of a patient, operative according to a further embodiment of the disclosed technique. DETAILED DESCRIPTION OF THE EMBODIMENTS
The disclosed technique overcomes the disadvantages of the prior art by providing a device and a method for reducing the displacement between two anchors of a heart valve implant, anchored to a heart valve, after anchoring the anchors to the heart valve annulus, and after completion of the heart valve implant procedure on the patient (i.e., removal of the catheter from the body of the patient, in case a catheter is employed for delivering the implant, suturing the incision of the chest of the body of the patient, in case of an open heart surgery, or removal of all the surgical instruments, in case of a minimal invasive surgery).
The displacement between the anchors is decreased at any desired time period after implanting the device, for example after days, weeks or months in one step or progressively reduced in steps, for example over the course of a few days, weeks or months. The displacement between the anchors can be reduced either in one session or in several sessions. The first displacement reduction session can be performed either immediately after the initial implant, or at a selected time thereafter. This device enables the heart, the vascular system, as well as the patient, to adjust itself over time to the change of shape and volume of the heart and heart chambers.
The displacement between the anchors is decreased at a desirable time period after completion of the heart valve implant procedure. Therefore, heart tissue is allowed to heal and grow, and the anchors are allowed to gain better adherence to the attachment region (i.e., the heart valve annulus and other adjacent tissue), thereby reducing the probability of ruptures of the heart valve tissue at the site of the anchors, and reducing the probability of detachment of the anchors from the heart valve annulus. Performing the reduction of the displacement between the anchors gradually (e.g., in several sessions), further minimizes the probability of tissue rupture and of detachment of the anchors from the heart valve annulus.
According to another aspect of the disclosed technique, the two anchors of the heart valve implant are deployed from a catheter which delivers the heart valve implant to the heart valve, simultaneously, thereby expediting the anchoring procedure of the anchors to the heart valve annulus. This aspect of the disclosed technique is beneficial to the physician, since the implant procedure is performed while the heart of the patient keeps beating and blood continues to flow. Therefore, the physician has to be provided with a device, which minimizes the time necessary to perform the heart valve implant procedure, and furthermore, interferes with the normal function of the heart, as little as possible.
According to another aspect of the disclosed technique the direction of the force applied to the two heart tissue anchors of the heart valve implant, when reducing the displacement between the heart tissue anchors, is substantially parallel to the inner heart contour wall to decrease the probability of ruptures in the heart tissue, or detachment of the heart tissue anchors from the heart valve annulus, while the two heart tissue anchors are being moved toward one another. The term "heart valve" herein below, refers to an anatomical valve of a heart of a patient, such as the mitral valve or the tricuspid valve. The term "heart valve axis" herein below, refers to a selected axis of a heart valve, for example, the antero-posterior axis of the mitral heart valve, or the axis defined by the posterior and septal leaflet portion of the tricuspid annulus, or the axis defined by septal leaflet annulus and the commissure between anterior and posterior leaflet of the tricuspid valve. For simplicity purposes, the following description shall refer mainly to the antero-posterior axis. However, it is noted that the disclosed technique can be implemented for any other axis within a heart valve. The term "complete heart valve implant procedure" herein below, refers to the final stage in a implant procedure on a heart valve of the heart of the body of the patient (i.e., removal of the catheter from the body of the patient, in case a catheter is employed to deliver the implant, suturing the incision of the chest of the body of the patient, in case of an open heart surgery, or removal of all the surgical instruments, in case of a minimal invasive surgery). The implant according to the disclosed technique includes a mechanism herein below referred to as "displacement reduction mechanism", which applies a force on the heart tissue anchors, to move the heart tissue anchors toward one another, thereby reducing the antero-posterior diameter of the heart valve. The disclosed technique can be employed for repairing a mitral valve, a tricuspid valve, and other similar anatomical structures. The disclosed technique can be employed in the body of humans as well as mammalians.
Reference is now made to Figures 1 , 2A, and 2B. Figure 1 is a schematic illustration of a cross section of a heart generally referenced 100, whose mitral valve annulus and left ventricle are dilated. Figure 2A is a schematic illustration of a top view of an implant generally referenced 130, to be attached to the mitral valve annulus of the heart of Figure 1 , in order to reduce the antero-posterior diameter of the mitral valve annulus and the volume of the left ventricle of the heart of Figure 1. Figure 2B is a schematic illustration of a side view of the implant of Figure 2A.
With reference to Figure 1 , a left ventricle 102 and a mitral valve annulus 104 are dilated. Due to increase in the antero-posterior diameter of mitral valve annulus 104, the coaptation between mitral valve leaflets 108 is poor, therefore causing mitral valve regurgitation. The devices and methods according to the disclosed technique, provide reduction of the antero-posterior diameter of mitral valve annulus 104, thus improving coaptation of leaflets 108, and reshaping left ventricle 102. Reduction of the antero-posterior diameter of mitral valve annulus 104 also improves the physical condition of a patient who suffers from dilated cardiomyopathy. This improvement is brought about by reducing valve regurgitation, reducing the volume of left ventricle 102, reducing the mechanical stress in the tissue of left ventricle 102, reducing oxygen consumption, restoring the normal heart anatomy, improving backing of left ventricle shortening and torque, increasing cardiac output, increasing left ventricle hemodynamic efficiency, and the like.
With further reference to Figures 2A and 2B, implant 130 includes an elastic movement provider 132, at least a first heart tissue anchor 134A, and at least a second heart tissue anchor 134B. The terms "at least one anterior heart tissue anchor" and "at least one posterior heart tissue anchor" in regard to a mitral valve implant procedure, in the description herein below, refer to "at least one first heart tissue anchor" and "at least one second heart tissue anchor", respectively. Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B includes a set of anchors 136A (Figure 2B) and 136B, respectively, to provide attachment of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B with mitral valve annulus 104. Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B are coupled with two ends of elastic movement provider 132. Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can slide relative to elastic movement provider 132, toward one another.
Implant 130 is to be implanted in a left atrium 106 (Figure 1 ) and attached to mitral valve annulus 104, to reduce the antero-posterior diameter of mitral valve annulus 104. Implant 130 can be implanted by various methods, such as percutaneous transluminal catheter delivery, minimal invasive catheter delivery, or open heart surgery. Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B are attached to mitral valve annulus 104 across the antero-posterior axis (for example, attaching anterior heart tissue anchor 134A to the anterior region of mitral valve annulus 104, and attaching posterior heart tissue anchor 134B to the posterior region of mitral valve annulus 104), such that an axis (not shown) which connects anterior heart tissue anchor 134A and posterior heart tissue anchor 134B, is substantially parallel to the antero-posterior axis of mitral valve annulus 104.
Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be attached to mitral valve annulus 104 in different ways, such as employing the set of anchors 136A and 136B, respectively, an adhesive, vacuum, suture, staple, or a combination thereof. For example, anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be initially attached to mitral valve annulus 104 by applying vacuum or pressure, and then attached by employing the set of anchors 136A and 136B, respectively. Each of the set of anchors 136A and 136B can be inclined to a surface (not shown), in order to increase the effective penetration depth in the tissue of mitral valve annulus 104.
Each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is constructed from a biocompatible material, such as Polytetrafluoroethylene, Silicone, Polyurethane, Nitinol, and the like. Additionally, anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be constructed in a form which promotes tissue in-growth, for example, by providing a plurality of perforations, in order to allow tissue in-growth, and the like. Each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be constructed from a biocompatible material which promotes tissue in-growth, in order to promote adherence of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to the tissue of mitral valve annulus 104. Alternatively, each of the bottom surfaces of the heart tissue anchors 134A and can be coated with a biocompatible material, which promotes tissue in-growth.
Each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is made of a rigid material. Alternatively, each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is made of a flexible material. In case implant 130 is delivered to the anchoring region of heart 100 by employing a catheter, anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be made from a flexible material, in order to allow anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to be folded within a sheath (not shown). This flexibility allows anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to conform to the contour of atrial wall 114, when implant 130 is deployed from the sheath, by forcing implant 130 out from the sheath (e.g., by employing an inflatable balloon). The contour of each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is in form of a closed curve, such as circle, ellipse, and the like. Alternatively, the contour of each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is in form of a polygon, such as rectangle, square, trapezoid, triangle, pentagon, hexagon, and the like. The shape of each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is flat. Alternatively, the shape of each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B is in form of a curved surface.
In order to relieve the physician of the burden of having to accurately locate implant 130 relative to mitral valve annulus 104, each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be constructed such that a width W thereof, is greater than a width (not shown) of mitral valve annulus 104 (i.e., between several millimeters and a few centimeters). Employing anterior heart tissue anchor 134A and posterior heart tissue anchor 134B of such a width, increases the probability of a stronger bond. The surface area, which includes mitral valve annulus 104, and adjacent tissue either of atrial wall 114 above and of leaflets 108 below, is herein below referred to as "attachment region". Alternatively, anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be with a width W equal or smaller that the width of mitral valve annulus 108. In this case, a higher level of precision is required on the part of the physician, in order to attach anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to mitral valve annulus 104, in an accurate manner.
In case implant 130 is delivered to the anchoring region of heart 100 by employing a catheter, anterior heart tissue anchor 134A and posterior heart tissue anchor 134B can be stowed within the sheath during the delivery, and deployed from the sheath. For example, a flexible element such as elastic movement provider 132 is employed to fold anterior heart tissue anchor 134A and posterior heart tissue anchor 134B, in a stowed position within the sheath. Elastic movement provider 132 is employed for the deployment of implant 130. Hence, elastic movement provider 132 can be employed for catheter based delivery of implant 130, as well as for deployment of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B, and attachment of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to mitral valve annulus 104.
Anterior heart tissue anchor 134A and posterior heart tissue anchor 134B are coupled to elastic movement provider 132 and can slide towards its center. This movement is provided for example, by providing a groove (not shown), in each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B, within which elastic movement provider 132 can move, thereby allowing relative movement between each of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B and elastic movement provider 132. The cross section of elastic movement provider 132 is in form of a closed curve (e.g., circle, ellipse), or a polygon (e.g., square, rectangle, triangle, trapezoid, hexagon, pentagon). Elastic movement provider 132 can be in form of a ribbon, wire, and the like. The physician can select an elastic movement provider of a desired length, among a plurality of different elastic movement providers of different lengths, according to the size of the heart valve annulus. Elastic movement provider 132 includes two connected wings, the flexibility of which enables deployment of implant 130, such that an angle between the two wings is between 120° to180°. Other deployment angles can be selected according to the application. The arrangement of implant 130 as set forth in Figure 2B, enables simultaneous deployment and anchoring of anterior heart tissue anchor 134A and posterior heart tissue anchor 134B to mitral valve annulus 104. Elastic movement provider 132 can be substantially rigid at a central portion thereof, and substantially flexible (e.g., radial flexibility) at regions away from the central portion (i.e., at the distal ends). This construction of elastic movement provider 132, ensures that implant 130 conforms to the curvature of left atrium 106, mitral valve annulus 104 and leaflets 108, and that a desired force is acting on the attachment region of mitral valve annulus 104, during the deployment, Elastic movement provider 132 can be constructed such that it is substantially elastic along a longitudinal axis 562 thereof. Elastic movement provider 132 can be constructed from a biocompatible material which inhibits tissue in-growth. Alternatively, elastic movement provider 132 can be coated with a biocompatible material which inhibits tissue in-growth.
It is noted that during a heart valve implant procedure on heart 100, the physician can employ a plurality of implants similar to implant 130. It is also noted that the implant can include more than two heart tissue anchors. The heart tissue anchors are attached to an anterior portion and to a posterior portion of the mitral valve annulus, such that the axis connecting the heart tissue anchors is substantially parallel with the antero-posterior axis of the mitral valve annulus. It is furthermore noted that the implant can include more than one elastic movement provider, each coupled with a plurality of heart tissue anchors. Alternatively, the elastic movement provider can be constructed in a star topology (e.g., an elastic movement provider having a plurality of legs, meeting at a common point, for example, in form of the letter Y or X). The physician can select the quantity of heart tissue anchors, the size of each of the heart tissue anchors, and the length of each of the heart tissue anchors, among a given set of heart tissue anchors, of different sizes, and different lengths.
Reference is now made to Figures 3A, 3B, 4A, 4B, 4C, 4D, and 4E. Figure 3A is a schematic illustration of a top view of an implant generally referenced 160, constructed and operative according to an embodiment of the disclosed technique, to be attached to the mitral valve annulus of the heart of Figure 1 , in order to reduce the antero-posterior diameter of the mitral valve annulus and the volume of the left ventricle of the heart of Figure 1. Figure 3B is a schematic illustration of a side view of the implant of Figure 3A. Figure 4A is a schematic illustration of a male portion of the heart tissue anchor assembly of the implant of Figure 3B. Figure 4B is a schematic illustration of a female portion of the heart tissue anchor assembly of Figure 3B. Figure 4C is a schematic illustration of a perspective exploded view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively. Figure 4D is a schematic illustration of a perspective view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively, during engagement. Figure 4E is a schematic illustration of a perspective view of the male portion and the female portion of the heart tissue anchor assembly of Figures 4A and 4B, respectively, after engagement.
Implant 160 includes an elastic movement provider 162 and heart tissue anchor assemblies 164A and 164B. Implant 160 is similar to implant 130 (Figure 2A), except that each of heart tissue anchor assemblies 164A and 164B is constructed such that implant 160 provides mechanical protection to mitral valve annulus 104 (Figure 1 ) and the heart tissue in the vicinity of the deployment site. For this purpose, each of heart tissue anchor assemblies 164A and 164B includes a male portion 166 and a female portion 168. Male portion 166 includes a plurality of barbs 170 protruding from a surface 172 of male portion 166. Each of barbs 170 is slanted to surface 172. Female portion 168 includes a plurality of perforations 174. The quantity, diameter and location of perforations 174 matches those of barbs 170. The contour of male portion 166 is substantially identical with that of female portion 168. The contour of each of male portion 166 and female portion 168 can be either a polygon (e.g., square, rectangle, trapezoid, triangle), or a closed curve (e.g., circle, ellipse).
Male portion 166 and female portion 168 are slidably coupled together. For example, female portion 168 can include a longitudinal groove (not shown), and male portion 166 can include a longitudinal protrusion (not shown), to match the longitudinal groove, such that male portion 166 can slide on female portion 168 along a direction designated by an arrow 176 (Figure 4D). The longitudinal protrusion is locked with the longitudinal groove, in order to prevent disengagement of male portion 166 from female portion 168, in a direction perpendicular to the direction of arrow 176.
Initially barbs 170 are located outside of perforations 174, and thus, a bottom surface 178 of female portion 168 provides mechanical protection of mitral valve annulus 104, leaflets 108, and atrial wall 114, from barbs 170. This provision allows the physician to position heart tissue anchor assemblies 164A and 164B, at the desired location, and then to adjust the position of heart tissue anchor assemblies 164A and 164B, to a desired location, without injuring the heart tissue. Following deployment and upon being placed at a required position, male portion 166 is moved relative to female portion 168, along the direction of arrow 176, wherein barbs 170 enter the respective perforations 174, male portion 166 locks into female portion 168, and barbs 170 pierce the tissue of mitral valve annulus 104, thereby implanting implant 160 on mitral valve annulus 104, leaflets 108, and atrial wall 114 during deployment and positioning of the implant. It is noted that the description herein above is one example to provide protection of mitral valve annulus 104, and that other methods can be employed to protect the heart tissue. Reference is now made to Figures 5A, and 5B. Figure 5A is a schematic illustration of an implant, generally referenced 220, attached to the mitral valve annulus of Figure 1 , prior to decrease in the opening of the mitral valve annulus, and constructed and operative according to another embodiment of the disclosed technique. Figure 5B is a schematic illustration of the implant of Figure 5A, after reducing the opening of the mitral valve annulus.
Implant 220 includes an elastic movement provider 222, an anterior heart tissue anchor 224A, and a posterior heart tissue anchor 224B. Anterior heart tissue anchor 224A and posterior heart tissue anchor 224B are coupled to elastic movement provider 222 and can slide towards its center.
A first thread 230A connects heart tissue anchor 224A , to a manifold (not shown) located outside the body of the patient. A second thread 230B connects heart tissue anchor 224B to the manifold.
After implanting implant 220 on mitral valve annulus 228, the physician pulls each of first thread 230A and second thread 230B, through the catheter, by employing the manifold, thereby moving heart tissue anchor 224A in a direction designated by an arrow 232A, and heart tissue anchor 224B, in a direction designated by an arrow 232B and reduces the displacement between anterior heart tissue anchor 224A and posterior heart tissue anchor 224B. This action reduces the antero-posterior diameter of mitral valve annulus 228 by a desired amount (Figure 5B), thereby improving coaptation of mitral valve leaflets 234. Alternatively, the physician can pull only one of first thread 230A or second thread 230B to reduce the displacement between anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, and to reduce the probability of detachment of heart tissue anchors 224A and 224B from the attachment region. Such a selection can be made in order to reduce the probability of ruptures in the tissue of mitral valve annulus 228, and the probability of detachment of heart tissue anchors 224A and 224B from the attachment region. It is noted that the physician can reduce the antero-posterior diameter of mitral valve annulus 228, after completion of the heart valve implant procedure (e.g., days, weeks, or months thereafter), in a percutaneous transluminal catheter delivery procedure, via first thread 230A and second thread 230B.
The catheter includes a position fixation mechanism 236 located at a tip thereof. Position fixation mechanism 236 can be reversibly coupled with the catheter, for example, by a screw thread, a latch, and the like. Position fixation mechanism 236 is a device, which is employed for maintaining the antero-posterior diameter of mitral valve annulus 228, at the desired value.
In the example set forth in Figures 5A and 5B, position fixation mechanism 236 can be in form of a clamp, which is coupled with the manifold by a position fixation thread (not shown). The physician locks first thread 230A and second thread 230B together, after pulling them by the desired amount, and then maintains the diameter of mitral valve annulus 228 at the desired value, by clamping first thread 230A and second thread 230B together, by position fixation mechanism 236.
Anterior heart tissue anchor 224A and posterior heart tissue anchor 224B can be maintained in the desired position, without employing position fixation mechanism 236, for example, by twisting first thread 230A and second thread 230B and then tying them together. Position fixation mechanism 236 can be employed additionally, to secure the tie. The procedure of maintaining heart valve anchors 224A and 224B at the desired position, as described herein above, can be performed in an open heart surgery, as well as percutaneous transluminal catheter intervention, and minimal invasive surgery.
Alternatively, the first thread and the second thread can merge together to a single thread, to enable the physician to pull the first thread and the second thread, by pulling only the single thread. It is noted that the catheter is directly coupled with a surface of elastic movement provider 222. Therefore, tensions in first thread 230A and second thread 230B acting on anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, are substantially tangent with the surface of mitral valve annulus 228, and hence forces which tend to tear mitral valve annulus 228
5 apart, or decouple anterior heart tissue anchor 224A and posterior heart tissue anchor 224B from mitral valve annulus 228, are minimized.
Decreasing the anter-posterior diameter of mitral valve annulus 228 in one step, induces a large amount of stress to the heart wall, and imposes a sudden adjustment of the heart to its sudden change of shape o and volume. In many cases, for example for patients with significant heart problems (e.g., severe congestive heart failure), it is beneficial to decrease the antero-posterior diameter of mitral valve annulus 228 in several steps, during a period of days to months, according to the physical condition of the patient. Decreasing the antero-posterior diameter of mitral valve s annulus 228 after days to months following the implant procedure, also increases the adherence of anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, to the adjacent tissue before exerting on anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, significant forces during the reshaping process. o The physician can perform a first contraction step immediately after anchoring implant 220, to achieve an initial reduction in the length of antero-posterior diameter of mitral valve annulus 228. At a later stage after the implantation and completion of the heart valve implant procedure (e.g., days, weeks, or months thereafter), the physician reduces the 5 antero-posterior diameter of mitral valve annulus 228 by a percutaneous transluminal catheter procedure. A catheter (not shown) is introduced in the left atrium, for example by methods described herein below. The catheter includes a device for grabbing either of first thread 230A and second thread 230B, or both, or for grabbing position fixation mechanism o 236. The physician can then pull first thread 230A and second thread 230B, in order to move anterior heart tissue anchor 224A and posterior heart tissue anchor 224B toward one another, and reduce the antero-posterior diameter of mitral valve annulus 228.
Additionally, implant 220 can include a device for automatically securing the required distance between anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, once anterior heart tissue anchor 224A and posterior heart tissue anchor 224B have been manually brought to that required position, for example as described herein below in connection with Figure 6A. Additionally, implant 220 can include a grabbing element (not shown - e.g., a hook) coupled with each of anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, to allow the physician to grab each of anterior heart tissue anchor 224A and posterior heart tissue anchor 224B, in order to move anterior heart tissue anchor 224A and posterior heart tissue anchor 224B toward one another.
Reference is now made to Figures 6A, 6B, and 6C. Figure 6A is a schematic illustration of a bottom view of an implant, generally referenced 260, constructed and operative according to a further embodiment of the disclosed technique. Figure 6B is a schematic illustration of a top view of the implant of Figure 6A. Figure 6C is a schematic illustration of a side view of the implant of Figure 6A. Implant 260 includes an elastic movement provider 262, and two heart tissue anchors 264A and 264B. Elastic movement provider 262 includes a plurality of protrusions 266. Each of heart tissue anchors 264A and 264B includes a plurality of perforations 268. Protrusions 266 and perforations 268 together constitute a position fixation mechanism. Heart tissue anchors 264A and 264B can slide along a longitudinal axis 270 of elastic movement provider 262. The size and position of each of protrusions 266 match those of perforations 268. The shape of protrusions 266 is such that the movement of heart tissue anchors 264A and 264B relative to elastic movement provider 262, is irreversible (i.e., once heart tissue anchors 264A and 264B are moved in directions designated by arrows 272A and 272B, respectively, they are locked in position, and can not move back in opposite directions).
This arrangement can be provided for example, by providing each of protrusions 266 a saw-tooth form, and each of perforations 268 a compatible rectangular contour. Alternatively, the protrusions can be formed inside each of the heart tissue anchors, and the perforations on the elastic movement provider. Each of heart tissue anchors 264A and 264B can be moved relative to elastic movement provider 262, as described herein above in connection with Figure 5A, as described herein below, or by other methods known in the art.
Reference is now made to Figures 7A, 7B, and 7C. Figure 7A is a schematic illustration of a bottom view of an implant, generally referenced 290, constructed and operative according to another embodiment of the disclosed technique. Figure 7B is a schematic illustration of a top view of the implant of Figure 7A. Figure 7C is a schematic illustration of a side view of the implant of Figure 7A.
Implant 290 includes an elastic movement provider 292, heart tissue anchors 294A and 294B, and a displacement reduction mechanism 296. Elastic movement provider 292 includes a plurality of protrusions 298. Each of heart tissue anchors 294A and 294B includes a plurality of perforations 300. Protrusions 298 and perforations 300 are similar to protrusions 266 (Figure 6C) and perforations 268, respectively. Protrusions 298 and perforations 300 together constitute a position fixation mechanism similar to the position fixation mechanism described herein above in connection with Figure 6A.
Displacement reduction mechanism 296 includes an atemporal elastic element 302 and temporal elements 304A and 304B. Atemporal elastic element 302 is coupled between heart tissue anchors 294A and 294B. Temporal elastic element 304A is coupled between heart tissue anchor 294A and one end of elastic movement provider 292. Temporal elastic element 304B is coupled between heart tissue anchor 294B and the other end of elastic movement provider 292. It is noted that implant 290 can be operational with only one of temporal elements 304A and 304B.
Atemporal elastic element 302 is made of an elastic material, whose spring constant is substantially constant over time. Atemporal elastic element 302 is made of a polymer or metal spring, and the like. Each of temporal elements 304A and 304B can be an elastic element whose spring constant reduces and loses potential energy (i.e., either tension or compression force) over time (i.e., each of temporal elements 304A and 304B undergoes a physical degradation). Alternatively, each of temporal elements 304A and 304B can be made of a non-elastic element, such as a biodegradable material, and the like, which disintegrates over time (i.e., each of temporal elements 304A and 304B undergoes a biological degradation). Further alternatively, each of temporal elements 304A and 304B, can include a plurality of temporal elements, each made of a biodegradable material. Atemporal elastic element 302 can be a tension element (i.e., resists a tensile force applied thereto).
In case both atemporal elastic element 302 and temporal elements 304A and 304B are a tension type elastic element, atemporal elastic element 302 applies forces (i.e., permanent forces) on heart tissue anchors 294A and 294B, to move heart tissue anchors 294A and 294B, in directions designated by arrows 306A and 306B, respectively. Temporal elements 304A and 304B apply forces (i.e., temporary forces) on heart tissue anchors 294A and 294B, respectively, in directions opposite to arrows 306A and 306B, respectively. In this sense, atemporal elastic elements 302 can be regarded as the permanent portion of displacement reduction mechanism 296, and temporal elements 304A and 304B, as the degradable portion of displacement reduction mechanism 296.
As each of temporal elements 304A and 304B gradually loses the tension forces thereof, over time, the tension forces thereof normally acting on heart tissue anchors 294A and 294B, are gradually reduced below that of atemporal elastic element 302. This lack of balance in forces, causes heart tissue anchors 294A and 294B to move in directions 306A and 306B, respectively, thereby reducing the antero-posterior diameter of a mitral valve annulus (not shown), to which heart tissue anchors 294A and 294B are anchored.
Alternatively, each of temporal elements 304A and 304B can be made of a non-elastic element, such as a biodegradable material, and the like, which disintegrates over time. Further alternatively, each of temporal elements 304A and 304B, can include a plurality of temporal elements, each made of a biodegradable material. The plurality of temporal elements can include biodegradable elements of different lengths, which disintegrate sequentially, causing a gradual reduction of the displacement between heart tissue anchors 294A and 294B. The disintegration rate can be controlled by employing an external energy source, which emits energy, thus causing disintegration of temporal elements 304A and 304B, by heating or by inducing an electric current, as described herein below. The disintegration rate can also be controlled by employing an external energy source, which generates a mechanical wave (e.g., ultrasonic wave, shock wave), thus causing disintegration of temporal elements 304A and 304B. Alternatively, this disintegration rate can be controlled by injecting a catalyst through the vascular system of the body of the patient.
Alternatively, a temporal compressive type elastic element (i.e., an elastic element which resists a compressive force applied thereto), is coupled between the two heart tissue anchors, and two atemporal compressive elastic elements are coupled between the respective heart tissue anchor, and the respective end of the elastic movement provider. The temporal compressive elastic element is an elastic element whose spring constant reduces and loses potential energy over time.
Further alternatively, the implant can be devoid of the elastic movement provider. In this case, the two heart tissue anchors are coupled together by a temporal element and an atemporal elastic element. The atemporal elastic element is an elastic element which applies a constant force on the two heart tissue anchors, to pull the two heart tissue anchors toward each other. The atemporal elastic element can be for example, in form of a tension spring, and the like. The temporal element is an element which initially applies a force on the two heart tissue anchors, to force the two heart tissue anchors away from one another. The temporal element can be for example, in form of a biodegradable element, a compression spring which loses the spring property thereof, over time, and the like. When the temporal element degrades and ceases to apply the repelling force on the two heart tissue anchors, the tension force of the atemporal elastic element, acts on the two heart tissue anchors, thereby pulling the two heart tissue anchors toward one another, and reducing the antero-posterior diameter of the heart valve annulus.
Reference is now made to Figures 8A, 8B, and 8C. Figure 8A is a schematic illustration of a top view of an implant, generally referenced 330, constructed and operative according to a further embodiment of the disclosed technique. Figure 8B is a schematic illustration of a side view of the implant of Figure 8A. Figure 8C is a schematic illustration of the implant of Figure 8A, in a contracted state. Implant 330 includes heart tissue anchors 334A and 334B, a displacement reduction mechanism 336, and an energy converter 338. Displacement reduction mechanism 336 is coupled between heart tissue anchors 334A and 334B. Energy converter 338 is coupled with displacement reduction mechanism 336. The physician delivers and anchors implant 330 to heart valve annulus (not shown), while displacement reduction mechanism 336 is in a relaxed state. Displacement reduction mechanism 336 is an element which changes shape when the temperature thereof is changed. Alternatively, displacement reduction mechanism 336 is an element which changes shape when an electric current flows there through. Displacement reduction mechanism 336 can be for example, in form of a shape memory element, made of a shape memory alloy (SMA) such as Nitinol, and the like. Energy converter 338 is an element which converts the energy emitted by an energy source (not shown) located external to the heart of the body of a patient, to heat. Alternatively, energy converter 338 is an element which converts the energy to electric current. The energy source emits electromagnetic radiation (e.g., radio frequency, microwave). Alternatively, the energy source emits acoustic energy (e.g., ultrasound). The energy source can be part of a medical imaging device, such a magnetic resonance imager (MRI), an MRI coil, an ultrasound probe, and the like.
In case the energy source emits electromagnetic radiation, energy converter 338 converts the electromagnetic radiation to heat, energy converter 338 transfers the heat to displacement reduction mechanism 336, and displacement reduction mechanism 336 changes shape due to the change in temperature. The change in the shape of displacement reduction mechanism 336 causes heart tissue anchors 334A and 334B to move toward one another, thereby reducing the antero-posterior diameter of a heart valve annulus.
In case the energy source emits electromagnetic radiation, energy converter 338 converts the electromagnetic radiation to an electric current, energy converter 338 transfers the electric current to displacement reduction mechanism 336, and displacement reduction mechanism 336 changes shape due to the electric current flowing there through. The change in the shape of displacement reduction mechanism 336 causes heart tissue anchors 334A and 334B to move toward one another, thereby reducing the antero-posterior diameter of a heart valve annulus.
In case, the energy source emits acoustic energy, energy converter 338 converts the acoustic energy to heat, energy converter 338 transfers the heat to displacement reduction mechanism 336, and displacement reduction mechanism 336 changes shape due to the change in temperature. The change in the shape of displacement reduction mechanism 336 causes heart tissue anchors 334A and 334B to move toward one another, thereby reducing the antero-posterior diameter of a heart valve annulus.
Alternatively, the displacement reduction mechanism can be made, of a material and in a shape, which converts the energy emitted by the energy source, to heat. Further alternatively, the displacement reduction mechanism can be made of a material, which converts the energy emitted by the energy source to an electric current. Alternatively, the displacement reduction mechanism is coated with a material which converts the energy emitted by the energy source to heat. Further alternatively, the displacement reduction mechanism can be coated with a material which converts the energy emitted by the energy source to an electric current. Alternatively, the displacement reduction mechanism can be constructed from a first element which changes shape due to a change in temperature, and a second element which converts the energy emitted by the energy source to heat (i.e., the energy converter is integrated with the displacement reduction mechanism. Further alternatively, the second element can convert the energy to an electric current. In these cases, the energy converter can be eliminated from the implant. For example, the energy source can emit electromagnetic radiation in the range of MHz to tens of MHz, and energy converter 338 can be a ferrite encapsulated within a biocompatible shell, wherein converter 338 converts the electromagnetic radiation to heat. For example, the energy source can generate an ultrasonic wave in the range of MHz to tens of MHz, and energy converter 338 can be made of a material highly absorbs ultrasonic energy, such as encapsulated Hysol, wherein converter 338 converts the absorbed ultrasonic energy to heat.
With reference to Figure 8C, displacement reduction mechanism 336 is bent due to the energy emitted by the external energy source. The bending of displacement reduction mechanism 336 reduces the displacement between heart tissue anchors 334A and 334B. In this manner it is ensured that displacement reduction mechanism 336 does not make contact with the leaflets (not shown) of the heart valve, while displacement reduction mechanism 336 is contracted. Alternatively, instead of the bending motion, displacement reduction mechanism 336 can contract in a linear manner, to reduce the displacement between heart tissue anchors 334A and 334B. Further alternatively, displacement reduction mechanism 336 can contract in a non-linear manner, to reduce the displacement between heart tissue anchors 334A and 334B. Displacement reduction mechanism 336 maintains the displacement between heart tissue anchors 334A and 334B, after moving heart tissue anchors 334A and 334B toward one another, and after the cessation of the energy emission by the energy source.
The energy source can be located for example, in the esophagus (transesophageal) of the body of the patient. The energy source emits energy in short cycles, in order to minimize sharp changes in temperature, and injury to the tissue of the body of the patient. Additionally, energy converter 338 is located in such a location (for example midway between heart tissue anchors 334A and 334B), so that no damage is induced to the tissue, and the generated heat is readily dissipated by the blood flow.
The physician exposes implant 330 to the energy source during the heart valve implant procedure, in order to reduce the antero-posterior diameter of the heart valve of the heart of the body of the patient. Alternatively, the physician exposes implant 330 to the energy source after completion of the heart valve implant procedure (e.g., hours, days, week, or months thereafter). The procedure of reducing the displacement between heart tissue anchors 334A and 334B, as described herein above, can be performed in a single session. Alternatively, the procedure can be performed in several sessions. Alternatively, displacement mechanism 336 can be made of a shape memory alloy which changes shape, when reaching the body temperature of the body of the patient. In this case displacement reduction mechanism 336 is maintained at a temperature lower than that of the body temperature, before anchoring implant 330 to the heart valve annulus. Further alternatively, displacement reduction mechanism 336 can be made of a shape memory alloy, which changes shape, when reaching a temperature higher than that of the body temperature. In this case, displacement reduction mechanism 336 can be heated by direct contact with a heating element (not shown), during the heart valve implant procedure. Alternatively, displacement reduction mechanism 336 can be heated by inducing an electric current there through, during the heart valve implant procedure. Further alternatively, displacement reduction mechanism 336 can be heated by direct contact with a heating element (not shown), by introducing a catheter in the left atrium, after completing the heart valve implant procedure, as described herein above. Alternatively, displacement reduction mechanism 336 can be heated by inducing an electric current there through, by introducing a catheter in the left atrium, after completing the heart valve implant procedure, as described herein above. Reference is now made to Figures 9A and 9B. Figure 9A is a schematic illustration of a patient, generally referenced 340, subject to an external source of energy. Figure 9B is a schematic illustration of a patient, generally referenced 350, subject to an internal source of energy.
With reference to Figure 9A, an external energy source 342 emits electromagnetic radiation, through a coil 344 located external to the body of patient 340. Alternatively, external energy source 342 can be an acoustic source which emits an acoustic wave, via an acoustic probe 344, located external to the body of patient 340. Further alternatively, a plurality of probes 344 located external to the body of patient 340 can be employed to emit the energy generated by external energy source 342. With reference to Figure 9 B, an external energy source 352 is coupled with a probe 354 located within the body of patient 350. Probe 354 is similar to probe 344 (Figure 9A) as described herein above.
The energy source can employ a probe to direct and focus the emitted energy toward the energy converter. The waveform and frequency of the energy source is selected to minimize heating and potential damage to tissue of the body of the patient.
Reference is now made to Figures 10A, 1OB, and 1OC. Figure 10A is a schematic illustration of a bottom view of an implant, generally referenced 370, constructed and operative according to another embodiment of the disclosed technique. Figure 10B is a schematic illustration of a top view of the implant of Figure 10A. Figure 10C is a schematic illustration of a side view of the implant of Figure 10A.
Implant 370 includes an elastic movement provider 372, heart tissue anchors 374A and 374B, a displacement reduction mechanism 376, and an energy converter 378. Displacement reduction mechanism 376 and energy converter 378, are similar to displacement reduction mechanism 336 (Figure 8A), and energy converter 338, respectively, as described herein above. Elastic movement provider 372 includes a plurality of protrusions 380. Each of heart tissue anchors 374A and 374B includes a plurality of perforations 382. Protrusions 380 and perforations 382 are similar to protrusions 266 (Figure 6C) and perforations 268, respectively. Protrusions 380 and perforations 382 together constitute a position fixation mechanism similar to the position fixation mechanism described herein above in connection with Figure 6A. The position fixation mechanism maintains displacement reduction mechanism 376 at the reduced length, once the heat causes a reduction in the length of displacement reduction mechanism 376, and thus a reduction in the antero-posterior diameter of the mitral valve annulus. Reference is now made to Figures 11 A, 11 B, and 11 C. Figure
11A is a schematic illustration of a bottom view of an implant, generally referenced 410, constructed and operative according to a further embodiment of the disclosed technique. Figure 11 B is a schematic illustration of a top view of the implant of Figure 11 A. Figure 11C is a schematic illustration of a side view of the implant of Figure 11A. Implant 410 includes an elastic movement provider 412, heart tissue anchors 414A and 414B, a flexible connector 416, and a displacement reduction mechanism 418. Flexible connector 416 can be in form of a wire, a thread, and the like. Displacement reduction mechanism 418 includes one or more actuators (not shown), which provides rotary motion. Alternatively, the actuators provide linear motion. Displacement reduction mechanism 418 is an element (e.g., microelectromechanical system - MEMS) whose temperature changes when subjected to an electromagnetic field (e.g., radio frequency, microwave). Displacement reduction mechanism 418 produces a mechanical motion (i.e., rotary, linear) due to this change in temperature. Alternatively, displacement reduction mechanism 418 is an element (e.g., MEMS) which generates an electric current (e.g., Eddy currents), when subjected to the electromagnetic field. Displacement reduction mechanism 418 produces a mechanical motion, due to this electric potential. Further alternatively, displacement reduction mechanism 418 produces a mechanical motion when exposed to an acoustic energy. In this case, displacement reduction mechanism 418 is made for example, from a piezoelectric material. Implant 410 can include a controller (not shown) to control the displacement reduction mechanism by a predetermined control signal, in order to prevent activation thereof by other signals, such as noise. Displacement reduction mechanism 418 can be an element which accumulates energy.
Displacement reduction mechanism 418 is coupled with heart tissue anchor 414A. Displacement reduction mechanism can include a pulley (not shown) mounted on a shaft thereof. One end of flexible connector 416 is wound around the pulley, and another end thereof is coupled with heart tissue anchor 414B. Displacement reduction mechanism 418 can include a stop (not shown), which prevents displacement reduction mechanism 418 to move in an opposite direction, once it has moved in a given direction. In the example set forth in Figure 11A1 displacement reduction mechanism 418 rotates in a direction designated by an arrow 420. This rotation applies a pull on heart tissue anchor 414B via flexible connector 416, and causes heart tissue anchor 414B to move in a direction designated by an arrow 422, against the tension in the mitral valve annulus (not shown), which tends to keep the mitral valve annulus at an increased diameter. The stop prevents displacement reduction mechanism 418 to rotate in a direction opposite to that of arrow 420, thereby maintaining the mitral valve annulus at the reduced diameter.
Additionally, implant 410 can include another displacement reduction mechanism 424 similar to displacement reduction mechanism 418. Displacement reduction mechanism 424 is coupled with heart tissue anchor 414B. One end of flexible connector 416 is wound around the pulley of displacement reduction mechanism 418, and the other end thereof is wound around another pulley of displacement reduction mechanism 424.
Reference is now made to Figures 12A, 12B, and 12C. Figure 12A is a schematic illustration of a bottom view of an implant, generally referenced 450, constructed and operative according to another embodiment of the disclosed technique. Figure 12B is a schematic illustration of a top view of the implant of Figure 12A. Figure 12C is a schematic illustration of a side view of the implant of Figure 12A.
Implant 450 includes an elastic movement provider 452, heart tissue anchors 454A and 454B, a flexible connector 456, and a displacement reduction mechanism 458. Elastic movement provider 452 includes a plurality of protrusions 460. Each of heart tissue anchors 454A and 454B includes a plurality of perforations 462. Protrusions 460 and perforations 462 are similar to protrusions 266 (Figure 6C) and perforations 268, respectively. Protrusions 460 and perforations 462 together constitute a position fixation mechanism similar to the position fixation mechanism described herein above in connection with Figure 6A. Flexible connector 456 and displacement reduction mechanism
458, are similar to flexible connector 416 (Figure 11A) and displacement reduction mechanism 418, as described herein above. The position fixation mechanism maintains the distance between heart tissue anchors 454A and 454B, at a reduced value, once displacement reduction mechanism 458 pulls heart tissue anchors 454A and 454B, toward one another. In this manner the mitral valve annulus is maintained at the reduced diameter, thereby preventing movement of heart tissue anchors 454A and 454B, in reverse direction. Additionally, implant 450 can include a displacement reduction mechanism 464 coupled with heart tissue anchor 454B.
According to another aspect of the disclosed technique, two heart tissue anchors of an implant are simultaneously anchored to a heart valve of the heart of a patient, after being deployed from a catheter which a physician passes to the heart valve region, through a blood vessel of the body of the patient. Since the implant is implanted while the heart is beating, and blood flow is intact, this simultaneous anchoring is crucial in order to perform the operation as quickly as possible, and to interrupt the normal function of the heart as little as possible. The length of the implant according to one aspect of the disclosed technique, is reduced only once, after being implanted. Alternatively, the length of the implant according to another aspect of the disclosed technique, can be reduced multiple times after being implanted. This option allows the physician to reduce the heart valve annulus diameter, at selected intervals after the implant, according to the physical condition of the patient. In this manner, the physician ensures that the heart properly adjusts to the desired diameter of the heart valve annulus, and furthermore, preventing rupture of the heart valve annulus, which can occur due to sudden reduction in the heart valve annulus diameter.
Reference is now made to Figures 13A, 13B, 13C, 13D, and 13E. Figure 13A is a schematic illustration of a system generally referenced 540, for deploying an implant from a sheath, to be implanted on a heart valve annulus, constructed and operative according to a further embodiment of the disclosed technique, the implant being in a stowed position within the sheath. Figure 13B is a schematic illustration of the implant of Figure 13A, while being deployed. Figure 13C is a schematic illustration of the implant of Figure 13A, while being deployed. Figure 13D is a schematic illustration of a system generally referenced 541 , for deploying an implant from a sheath, to be implanted on a heart valve annulus, constructed and operative according to another embodiment of the disclosed technique, the implant being in a stowed position within the sheath. Figure 13E is a schematic illustration of the implant of Figure 13D, while being deployed.
System 540 includes a catheter 542, a sheath 544, and an implant 546. Implant 546 is similar for example, to either of implants 130 or 160, as described herein above in connection with Figures 2A and 3A, respectively, as well other implants as described herein above. Implant 546 includes an anterior heart tissue anchor 548A and a posterior heart tissue anchor 548B, and an elastic movement provider 550. Each of anterior heart tissue anchor 548A and posterior heart tissue anchor 548B includes a set of anchors 552. Anterior heart tissue anchor 548A is coupled with one end of elastic movement provider 550. Posterior heart tissue anchor 548B is coupled with another end of elastic movement provider 550. Catheter 542 is located within sheath 544, and can freely move back and forth through sheath 544.
Sheath 544 is made of a rigid material. Alternatively, sheath 544 is made of a flexible material. Alternatively, a proximal section of sheath 544 is substantially rigid and a distal end thereof is substantially flexible. Further alternatively, sheath 544 is originally in a flexible form, and then changes to a more rigid form, for example, by employing a mechanism similar to articulating arm Estech (not shown), and the like. Elastic movement provider 550 is made of a material, which can reversibly bend about an axis perpendicular to a longitudinal axis (not shown) thereof. Elastic movement provider 550 can be made of an elastic material, such as metal leaf spring, polymer, shape memory alloy (e.g., Nitinol), and the like.
With reference to Figure 13A, elastic movement provider 550 is bent over a tip 554 of catheter 542, within sheath 544, in a folded configuration. Elastic movement provider 550 is reversibly coupled with tip 554 of catheter 542, for example by a screw thread (not shown), and the like. Due to a bending moment which acts in elastic movement provider 550, heart tissue anchors 548A and 548B apply forces in directions designated by arrows 556A and 556B on an inner wall of sheath 544. These forces are resisted by the inner wall of sheath 544. In this manner, implant 546 is stowed within sheath 544. Alternatively, the elastic movement provider can be kept in the folded configuration within the sheath, by employing a restraining device, for example, a thread, a clamp, and the like. The physician can release the restraining device to move the elastic movement provider from the folded configuration, to a deployment configuration, out of the sheath.
With reference to Figure 13B, the physician withdraws sheath 544 over catheter 542, in a direction designated by an arrow 558, thereby allowing the bending moment in elastic movement provider 550, to spring open implant 546, over tip 554 of catheter 542. It is noted that instead of withdrawal of sheath 544, the physician can move tip 554 of catheter 542 forward in a direction designated by an arrow 564, in order to deploy implant 546. With reference back to Figure 2A, implant 546 can include in addition, a first hinge 560A, a second hinge 560B, a first elastic element (not shown) and a second elastic element (not shown). Anterior heart tissue anchor 548A can rotate by approximately ninety degrees on first hinge 560A, about a first axis (not shown) perpendicular to a longitudinal axis 562, wherein the first axis is perpendicular to the sheet of Figure 2A. Similarly, posterior heart tissue anchor 548B can rotate by approximately ninety degrees on second hinge 560B, about a second axis (not shown) perpendicular to longitudinal axis 562, wherein the second axis is perpendicular to the sheet of Figure 2A. The first elastic element and the second elastic element are coupled with first hinge 560A and with second hinge 560B, respectively.
Each of anterior heart tissue anchors 548A and posterior heart tissue anchor 548B are rotated about first hinge 560A and 560B, respectively, against the elastic force of the first elastic element and the second elastic element, respectively, while implant 546 is stowed within sheath 544, such that length dimensions L1 (Figure 2A) and L2 of heart tissue anchors 548A and 548B, respectively, are substantially parallel with longitudinal axis 562. When the physician withdraws sheath 544, anterior heart tissue anchors 548A and posterior heart tissue anchor 548B turn by approximately ninety degrees about first hinge 560A and second hinge 560B, to the state illustrated in Figure 2A. This option allows the physician to stow implant 546 within sheath 544, in a more compact configuration.
With reference to Figure 13C, implant 546 moves from the folded configuration to a deployment configuration, to deploy completely to an angle between 120 and 240 degrees, in order to match the inner contour of the heart (the atrial wall, the heart valve annulus and the leaflets). This movement also deploys anchors 552 to penetrate the tissue of the heart valve annulus, simultaneously.
According to another aspect of the disclosed technique, a system similar to system 540 (Figure 13A) is employed to anchor two heart tissue anchors of a heart valve implant, to a heart valve annulus of a heart valve, and to reduce the antero-posterior diameter of the heart valve annulus, by applying forces to the two heart tissue anchors, in such directions, that minimal injury is imparted to the heart valve annulus. When the expander moves the heart valve implant from the folded configuration to the deployment, out of the sheath, the expander applies a first force to each heart tissue anchor, against the heart valve annulus, in a first direction substantially normal to a surface of the heart valve annulus. This first force anchors each of the heart tissue anchors to the heart valve annulus.
Simultaneously, the physician applies a second force on each of the heart tissue anchors, by employing the displacement reduction mechanism, to move the two heart tissue anchors toward one another. The second force is applied in a direction (i.e., a second direction), toward a center of the heart valve annulus, and away from the first direction and a tangent to the surface of the heart valve annulus. The vectorial sum of the first force and the second force (i.e., a third force), is in a third direction, substantially parallel to the heart inner contour. It is noted that by applying the first force on each of the heart tissue anchors while applying the second force, the physician reduces the probability of detachment of the heart tissue anchors from the heart valve annulus, and minimizes the probability of tissue rupture during the procedure of reducing the antero-posterior diameter of the heart valve annulus.
With respect to Figures 13D and 13E, system 541 includes a catheter 543, a sheath 545, and an implant 547. Implant 547 is similar to implant 546 as described herein above. Implant 547 includes a first heart tissue anchor 549A1 a second heart tissue anchor 549B, and an elastic movement provider 551. Each of first heart tissue anchor 549A and second heart tissue anchor 549B includes a set of anchors (not shown). First heart tissue anchor 549A and second heart tissue anchor 549B are coupled with the two ends of elastic movement provider 551 , and can slide relative to elastic movement provider 551 , toward one another. Catheter 543 is located within sheath 545, and can freely move back and forth through sheath 545.
Elastic movement provider 551 includes two wings 559A and 559B of different lengths. Wing 559A is longer than wing 559B enabling to position heart tissue anchor 549A further away from the distal end of catheter 543 than heart tissue anchor 549B. Relative to the configuration illustrated in Figure 13A, this configuration enables to increase the size of each of heart tissue anchor 549A and 549B for the same lumen diameter of sheath 545. Alternately, wing 559A is shorter wing 559B. Although, the deployment of heart tissue anchor 549A and 549B is quasi-simultaneous, their positioning and attachment can be simultaneous according to the techniques illustrated below herein.
Reference is now made to Figures 14A, 14B, 14C, and 14D. Figure 14A is a schematic illustration of the implant of Figure 13A, in a deployed position, while being located within a left atrium of the heart of a patient by percutaneous transluminal catheter delivery. Figure 14B is a schematic illustration of the implant of Figure 13B in a deployed position, while being located within the left atrium. Figure 14C is a schematic illustration of the implant of Figure 13C, while being anchored to a mitral valve annulus of the heart, and still engaged with the catheter. Figure 14D is a schematic illustration of the implant of Figure 14C, being permanently anchored to the mitral valve annulus and disengaged from the catheter.
With reference to Figure 14A, catheter 542 is located within a left atrium 566 of a heart 568 of the body of a patient (not shown), and implant 546 is stowed within sheath 544 (Figure 13A). Catheter 542 can be delivered to a right atrium (not shown) of heart 568, for example, by being introduced into the venous system (not shown) of the body of the patient, either through the jugular vein via the superior vena cava and then into the right atrium, or through the femoral vein via the inferior vena cava into the right atrium. Subsequently, catheter 542 is introduced from the right atrium into left atrium 566 trans-septally via a septum 578 which separates the right atrium and left atrium 566. Such trans-septal introduction of catheter 542 is known in the art, and used for other medical procedures as well.
Catheter 542 can be delivered through sheath 544 (Figure 13A). The usage of sheath 544 provides a tunnel for delivery of catheter 542. Sheath 544 is made of a rigid material. Alternatively, sheath 544 is made of a flexible material. Further alternately, the proximal portion of sheath 544 is substantially rigid and a distal end thereof is substantially flexible. The rigid portion of sheath 544 provides the counterforce force necessary to transform the force exerted by the physician at a proximal end of catheter 542, to a force in the appropriate direction, in order to force the implant 546 against the mitral valve annulus. Alternatively, sheath 544 is originally in a flexible form, and then changes to a more rigid form, for example, by employing a mechanism similar to articulating arm Estech (not shown), and the like.
Catheter 542 is then maneuvered to substantially point towards the center of the mitral valve, and then rotated to ensure that in its deployed state the long dimension of implant 546 is substantially parallel to the antero-posterior axis of a mitral valve annulus 570 of heart 568. With reference to Figure 14B, implant 546 is deployed from sheath 544, and still coupled with catheter 542 at tip 554 thereof. The long dimension of implant 546 is substantially parallel to the antero-posterior axis of a mitral valve annulus 570 of heart 568. With reference to Figure 14C, the deployment force which springs open implant 546, simultaneously anchors both heart tissue anchors 548A and 548B to mitral valve annulus 570. With reference to Figure 14D, a displacement reduction mechanism 572 moves heart tissue anchors 548A and 548B toward one another, thereby reducing the antero-posterior diameter of mitral valve annulus 570. The physician can disengage implant 546 from catheter 542, for example, by unscrewing the screw thread located at tip 554 of catheter 542. The reduction of the antero-posterior diameter of mitral valve annulus 570 brings about improved coaptation of mitral valve leaflets of heart 568, and reshaping of a left ventricle 574 of heart 568. Reduction of the antero-posterior diameter of mitral valve annulus 570, also reduces the volume of a left ventricle 574 of heart 568, in order to treat for example, congestive heart failure. The entire procedure (i.e., delivery and deployment of the catheter, anchoring and reduction of the mitral valve annulus diameter), can be performed with the assistance of medical imaging device such as an external ultrasound imager, transesophageal ultrasound imager, and the like.
Displacement reduction mechanism 572 can be constructed as described herein above. The antero-posterior diameter can be reduced a multiple number of times, after anchoring implant 546 to mitral valve annulus, as described herein above. The reduction of antero-posterior diameter of the mitral valve can be performed either before or after disengaging implant 546 from catheter 542.
Alternately, the physician can deliver implant 546 to left atrium 566, in a minimal invasive procedure. The physician can implant heart valve implant 546 intra-operatively by puncturing the free wall of left atrium 566. The physician can place a purse-string stitch on the left atrial wall around the place of insertion, in order to prevent bleeding during the insertion of implant 546. The physician can perform this operation by employing either a minimal invasive method, or totally endoscopycally through the right pleural space with a thoracoscope and manipulators. The physician can perform this procedure either with or without cardiopulmonary bypass, through midstemotomy. The entire procedure (i.e., delivery and deployment of the catheter, anchoring, and reduction of the mitral valve annulus diameter), can be performed with the aid of a medical imaging device (not shown) such as an external ultrasound imager, transesophageal ultrasound imager, and the like. Further alternately, the physician can deliver implant 546 through a surgical procedure. The physician can perform this procedure either with or without cardiopulmonary bypass, through midsternotomy.
Alternative methods can be employed to deliver and anchor implants described herein above to a heart valve annulus. For example, the physician can deliver and deploy the implant in several steps. At the first stage, the physician delivers and deploys the first heart tissue anchor, positions, and then anchors the anterior heart tissue anchor on the anterior side of the mitral valve annulus. At the second stage, the physician delivers and deploys the second heart tissue anchor, and then positions and anchors the second heart tissue anchor to the mitral valve annulus, opposite the first heart tissue anchor such the axis connecting the first and the second heart tissue anchors is substantially parallel with the antero-posterior axis of the mitral valve annulus..
Reference is now made to Figures 15A, 15B, and 15C. Figure 15A is a schematic illustration of a system generally referenced 590, for deploying an implant from a sheath, to be implanted on a heart valve annulus of the heart of a patient, constructed and operative according to a further embodiment of the disclosed technique, the implant being in a stowed position within the sheath. Figure 15B is a schematic illustration of the implant of Figure 15A, while being deployed. Figure 15C is a schematic illustration of the implant of Figures 15A and 15B.
System 590 includes a catheter 592, a sheath 594, and an implant 596. Implant 596 includes heart tissue anchors 598A and 598B, and an elastic movement provider 600. Implant 596 can be deployed in a manner similar to the one described herein above in connection with Figures 13A1 13B, and 13C. Each of heart tissue anchors 598A and 598B is made of a self-expandable wire mesh, made of a material which expands as a result of a change in temperature, such as Nitinol, and the like. Heart tissue anchors 598A and 598B are coupled with elastic movement provider 600 by a plurality of elastic connectors 602A and 602B, respectively. Each of elastic connectors is in form of a wire made from an elastic material, such as polymer, elastic metal, and the like.
Reference is now made to Figure 16 which is a schematic illustration of an implant generally referenced 620, constructed and operative according to another embodiment of the disclosed technique. Implant 620 includes heart tissue anchors 622A and 622B, an elastic movement provider 624, and a plurality of elastic connectors 626A and 626B. Each of heart tissue anchors 622A and 622B is made of a flexible material which includes a plurality of self-expandable wires 628A and 628B. Self-expandable wires 628A and 628B are made of a material which can expand when subjected to a change in temperature, such as Nitinol, and the like. Heart tissue anchors 622A and 622B are coupled with elastic movement provider 624, by elastic connectors 626A and 626B, respectively. Reference is now made to Figure 17 which is a schematic illustration of an implant generally referenced 650, constructed and operative according to a further embodiment of the disclosed technique. Implant 650 includes heart tissue anchors 652A and 652B, an elastic movement provider 654, and a plurality of elastic connectors 656A and 656B. Each of heart tissue anchors 652A and 652B is made of a flexible material, such as a polymer, and the like. Each of elastic connectors 656A and 656B is made of an elastic material, such as polymer, metal wire spring, and the like.
Heart tissue anchors 652A and 652B are coupled with elastic movement provider 654, by elastic connectors 656A and 656B, respectively. While implant 650 is delivered by a catheter (not shown) to a region of a heart valve annulus (not shown) of the heart of a patient, implant 650 is stowed within a sheath of the catheter. When implant 650 exits the sheath and springs open, elastic connectors 656A and 656B spring open too, thereby spreading open each of heart tissue anchors 652A and 652B, in order to be anchored simultaneously to the heart valve annulus of the heart.
Reference is now made to Figures 18A and 18B. Figure 18A is a schematic illustration of a system generally referenced 680, for deploying an implant from a sheath, constructed and operative according to another embodiment of the disclosed technique, the implant being stowed within the sheath. Figure 18B is a schematic illustration of the implant of Figure 18A, in a deployed position.
System 680 includes a catheter 682, a sheath 684, an implant 686, and an expander 688. Implant 686 includes heart tissue anchors 690A and 690B, and an elastic movement provider 692. Catheter 682, sheath 684, and implant 686 are similar to catheter 542 (Figure 13A), sheath 544, and implant 546, as described herein above. In the example set forth in Figures 18A and 18B, expander 688 is in form of a balloon. Balloon 688 is located at a distal end 694 of catheter 682.
With reference to Figure 18A, implant 686 is stowed within sheath 684, with elastic movement provider 692 bent over distal end 694, and heart tissue anchors 690A and 690B located between the periphery of balloon 688 and an inner wall of sheath 684. With reference to Figure 18B, the physician withdraws sheath 684, thereby exposing balloon 688, and inflates balloon 688. Balloon 688 expands and forces implant 692 open against a heart valve annulus (not shown) of the heart of the patient, thereby simultaneously anchoring heart tissue anchors 690A and 690B, to the heart valve annulus. The physician can inflate balloon 688 until balloon 688 occupies the entire volume of the left atrium of the heart of the patient. The physician can maintain balloon 688 in the inflated state, until she ensures that heart tissue anchors 690A and 690B are anchored to the heart valve annulus. Alternatively, implant 692 can include a stop (not shown) coupled with elastic movement provider, in order to prevent return of implant 692 from the deployed position toward the stowed position. It is noted that the physician employs system 680 while the heart of the body of the patient is beating and blood flow in the heart is intact. Hence, balloon 688 and accompanying elements, such as a remote inflating device (not shown), have to be constructed in such a manner that rapid inflation and deflation is ensured. This is necessary in order to incur least damage to the heart.
Reference is now made to Figures 19A and 19B. Figure 19A is a schematic illustration of a system generally referenced 720, for deploying an implant from a sheath, constructed and operative according to a further embodiment of the disclosed technique, the implant being stowed within the sheath. Figure 19B is a schematic illustration of the implant of Figure 19A, in a deployed position.
System 720 includes a catheter 722, a sheath 724, an implant 726, and an expander 728. Implant 726 includes heart tissue anchors 730A and 730B, and an elastic movement provider 732. Catheter 722, sheath 724, and implant 726 are similar to catheter 542 (Figure 13A), sheath 544, and implant 546, as described herein above. In the example set forth in Figures 19A and 19B, expander 728 can be in form of a shape memory alloy, such as Nitinol, and the like, which expands (i.e., the volume thereof increases), when subjected to a change in temperature. Expander 728 is located at a distal end 734 of catheter 722. Except the type of the expander, system 720 is similar to system 680 (Figures 18A and 18B) as described herein above.
Reference is now made to Figures 2OA and 2OB. Figure 2OA is a schematic illustration of a system generally referenced 760, for deploying an implant from a sheath, constructed and operative according to another embodiment of the disclosed technique, the implant being stowed within the sheath. Figure 2OB is a schematic illustration of the implant of Figure 2OA, in a deployed position.
System 760 includes a catheter 762, a sheath 764, an implant 766, and an expander 768. Implant 766 includes heart tissue anchors 770A and 770B, and an elastic movement provider 772. Catheter 762, sheath 764, and implant 766 are similar to catheter 542 (Figure 13A), sheath 544, and implant 546, as described herein above. In the example set forth in Figures 2OA and 2OB, expander 768 includes a plurality of elastic elements 774A and 774B, such as leaf springs made from a sheet metal, polymer, and the like (i.e., an elastic material). Expander 768 is located at a distal end 776 of catheter 762, and coupled therewith.
When implant 766 is stowed within sheath 764, heart tissue anchors 770A and 770B are located between the tips of the leaf springs (i.e., expander 768), and the inner wall of sheath 764. In this state, expander 768 is in a compressed state. When the physician withdraws sheath 764 over catheter 762, the tension in elastic elements 774A and 774B is released and elastic elements 774A and 774B (i.e., the leaf springs), force open heart tissue anchors 770A and 770B, respectively, against the mitral valve annulus. The fact that expander 768 is in form of leaf springs, it is ensured that blood continues to flow within the heart, while the physician performs the implant, thereby allowing more time for the physician to perform the operation.
Reference is now made to Figure 21 , which is a schematic illustration of a method for reducing the antero-posterior diameter of heart valve annulus of a malfunctioning heart valve of the heart of the body of a patient, operative according to a further embodiment of the disclosed technique. In procedure 800, a heart valve implant is delivered to a malfunctioning heart valve of the heart of the body of the patient. With reference to Figure 14A, the physician delivers implant 546 to left atrium 566, via catheter 542, for implanting on mitral valve annulus 570 of heart 568 of the patient.
In procedure 802, an anterior heart tissue anchor of the heart valve implant is anchored to an anterior region of the heart valve annulus of the malfunctioning heart valve. With reference to Figure 14C, heart tissue anchor 548A is anchored to an anterior region of mitral valve annulus 570. In procedure 804, a posterior heart tissue anchor of the heart valve implant is anchored to a posterior region of the heart valve annulus of the malfunctioning heart valve. With reference to Figure 14C, heart tissue anchor 548B is anchored to a posterior region of mitral valve annulus 570.
In procedure 806, the displacement between the anterior heart tissue anchor and the posterior heart tissue anchor is reduced, by exposing the heart valve implant to an energy source, to move the anterior heart tissue anchor and the posterior heart tissue anchor, toward one another, wherein the energy source is located external to the heart of the body of the patient. With reference to Figures 8A, 8B and 8C when the energy source emits energy toward implant 330, energy converter 338 converts this energy to heat, and this heat causes a reduction in the length of displacement reduction mechanism 336. This reduction in length moves heart tissue anchors 334A and 334B toward one another, thereby reducing the antero-posterior diameter of a mitral valve annulus (not shown), on which implant 330 is implanted.
The physician can repeat procedure 806 any number of times, in order to ensure proper adjustment of the heart to implant 546, and furthermore, to decrease the probability of ruptures in the anchoring region of mitral valve annulus 570, by allowing sufficient time for the mitral valve tissue to heal and grow.
It will be appreciated by persons skilled in the art that the disclosed technique is not limited to what has been particularly shown and described hereinabove. Rather the scope of the disclosed technique is defined only by the claims, which follow.

Claims

1. Device for reducing the antero-posterior diameter of a heart valve annulus of a heart valve of the heart of the body of a patient, the device comprising: at least one anterior heart tissue anchor, to be anchored to an anterior region of said heart valve annulus; at least one posterior heart tissue anchor, to be anchored to a posterior region of said heart valve annulus; and a displacement reduction mechanism, coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor, said displacement reduction mechanism moving at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, when said displacement reduction mechanism is exposed to an energy emitted by an energy source located external to said heart.
2. The device according to claim 1 , further comprising an energy converter coupled with said displacement reduction mechanism, wherein said displacement reduction mechanism comprises at least one shape memory element coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor, wherein said energy source emits an electromagnetic radiation, wherein said energy converter converts said electromagnetic radiation to heat,
, wherein said energy converter transfers said heat to said displacement reduction mechanism, wherein the temperature of said at least one shape memory element changes due to said heat, wherein the shape of said at least one shape memory element changes due to said change in said temperature, and wherein said at least one shape memory applies a force on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, due to said change in said shape, to move said at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another.
3. The device according to claim 2, wherein said energy converter is in form of a coating which coats said displacement reduction mechanism.
4. The device according to claim 2, wherein said energy converter is integrated with said displacement reduction mechanism.
5. The device according to claim 1 , further comprising an energy converter coupled with said displacement reduction mechanism, wherein said displacement reduction mechanism comprises at least one shape memory element coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor, wherein said energy source emits an acoustic energy, wherein said energy converter converts said acoustic energy to heat, wherein said energy converter transfers said heat to said displacement reduction mechanism, wherein the temperature of said at least one shape memory element changes due to said heat, wherein the shape of said at least one shape memory element changes due to said change in said temperature, and wherein said at least one shape memory applies a force on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, due to said change in said shape, to move said at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another.
6. The device according to claim 1 , further comprising an energy converter coupled with said displacement reduction mechanism, wherein said displacement reduction mechanism comprises at least one shape memory element coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor, wherein said energy source emits an electromagnetic radiation, wherein said energy converter converts said electromagnetic radiation to an electric current, wherein said energy converter transfers said electric current to said displacement reduction mechanism, wherein the temperature of said at least one shape memory element changes due to said electric current, wherein the shape of said at least one shape memory element changes due to said change in said temperature, and wherein said at least one shape memory applies a force on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, due to said change in shape, to move said at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another.
7. The device according to claim 1 , wherein said displacement reduction mechanism comprises: at least one actuator coupled with said at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor; and a flexible connector coupled with said at least one actuator, and 5 wherein said at least one actuator converts an electromagnetic radiation emitted by an energy source to heat, wherein said energy source is located external to said heart, and wherein said at least one actuator converts said heat to mechanical motion, to move said at least one of said at least one o anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, via said flexible connector.
8. The device according to claim 7, wherein said mechanical motion is rotary. 5
9. The device according to claim 7, wherein said mechanical motion is linear.
10. The device according to claim 1 , wherein said displacement reduction o mechanism comprises: at least one actuator coupled with at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor; and a flexible connector coupled with said at least one actuator, 5 wherein said at least one actuator converts an electromagnetic radiation emitted by an energy source to an electric current, wherein said energy source is located external to said heart, and wherein said at least one actuator converts said electric current to mechanical motion, to move said at least one of said at least one 0 anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, via said flexible connector.
11. The device according to claim 1 , wherein said displacement reduction mechanism comprises: at least one actuator coupled with at least one of said at least 5 one anterior heart tissue anchor and said at least one posterior heart tissue anchor; and a flexible connector coupled with said at least one actuator, wherein said at least one actuator converts an acoustic energy emitted by an energy source, to mechanical motion, to move said at io least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, via said flexible connector, and wherein said energy source is located external to said heart.
i5 12. The device according to claim 11 , wherein said at least one actuator is a piezoelectric element.
13. The device according to claim 1 , wherein a heart tissue anchor width of said at least one anterior heart tissue anchor and said at least one
20 posterior heart tissue anchor, is greater than a heart valve annulus width of said heart valve annulus.
14. The device according to claim 1 , further comprising at least one position fixation mechanism coupled with said at least one of said at
25 least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor, said at least one position fixation mechanism enabling fixation of said at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, at a selected position, after said displacement
30 reduction mechanism moves at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, to said selected position.
15. The device according to claim 1 , wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, is made of substantially flexible material.
16. The device according to claim 1 , wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor is made of a biocompatible material, to promote tissue in-growth.
17. The device according to claim 1 , wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor is coated by a biocompatible material, to promote tissue in-growth.
18. The device according to claim 1 , wherein said heart valve is a mitral valve.
19. The device according to claim 1 , wherein said heart valve is a tricuspid valve.
20. Device for reducing the antero-posterior diameter of a heart valve annulus of a heart valve of the heart of the body of a patient, the device comprising: at least one anterior heart tissue anchor, to be anchored to an anterior region of said heart valve annulus; at least one posterior heart tissue anchor, to be anchored to a posterior region of said heart valve annulus; and a degradable displacement reduction mechanism, coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor, said displacement reduction mechanism moving at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, as said displacement reduction mechanism exhibits degradation.
21. The device according to claim 20, wherein said displacement reduction mechanism comprises: at least one atemporal elastic element coupled between said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, said at least one atemporal elastic element applying a substantially permanent force on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, said permanent force forcing said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another; and at least one temporal element coupled between said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, said at least one temporal element applying a temporary force on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, to move said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, away from one another, a temporary force value of said temporary force being substantially equal to a vectorial sum of a permanent force value of said substantially permanent force, and an expanding force value of a heart valve annulus expanding force of said heart valve annulus, keeping said antero-posterior diameter at an enlarged value, wherein said temporary force value changes to a value less than said vectorial sum, when said at least one temporal element degrades, and wherein said substantially permanent force causes said at least 5 one anterior heart tissue anchor and said at least one posterior heart tissue anchor, to move toward one another.
22. The device according to claim 20, further comprising an elastic movement provider coupled between said at least one anterior heart io tissue anchor and said at least one posterior heart tissue anchor, said elastic movement provider providing movement of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, said displacement reduction mechanism comprising: i5 at least one atemporal elastic element, a respective one of said at least one atemporal elastic element being coupled with a respective one of said at least one anterior heart tissue anchor, and with said elastic movement provider, another respective one of said at least one atemporal elastic element being coupled with another
20 respective one of said at least one posterior heart tissue anchor, and with said elastic movement provider, said at least one atemporal elastic element applying a substantially permanent force on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, said permanent force forcing said at
25 least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another; and at least one temporal element coupled between said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, said at least one temporal element applying a
30 temporary force on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, to move said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, away from one another, a temporary force value of said temporary force being substantially equal to a vectorial sum of a permanent force value of said substantially permanent force, and an expanding force value of a heart valve annulus expanding force of said heart valve annulus, keeping said antero-posterior diameter at an enlarged value, wherein said temporary force value changes to a value less than said vectorial sum, when said at least one temporal element degrades, and wherein said substantially permanent force causes said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, to move toward one another.
The device according to claim 20, further comprising an elastic movement provider coupled between said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, said elastic movement provider providing movement of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, said displacement reduction mechanism comprising: at least one atemporal elastic element coupled between said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, said at least one atemporal element applying a permanent force on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, to move said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, and at least one temporal elastic element, a respective one of said at least one temporal elastic element being coupled with a respective one of said at least one anterior heart tissue anchor, and with said elastic movement provider, another respective one of said at least one temporal elastic element being coupled with another respective one of said at least one posterior heart tissue anchor, and with said elastic movement provider, said at least one temporal elastic element applying a substantially temporary force on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, said temporary force forcing said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, away from one another, a temporary force value of said temporary force being substantially equal to a vectorial sum of a permanent force value of said substantially permanent force, and an expanding force value of a heart valve annulus expanding force of said heart valve annulus, keeping said antero-posterior diameter at an enlarged value, wherein said temporary force value changes to a value less than said vectorial sum, when said at least one temporal element degrades, and wherein said substantially permanent force causes said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, to move toward one another.
24. The device according to claim 20, wherein said displacement reduction mechanism degrades biologically.
25. The device according to claim 20, wherein said displacement reduction mechanism degrades physically.
26. The device according to claim 20, wherein a heart tissue anchor width of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, is greater than a heart valve annulus width of said heart valve annulus.
27. The device according to claim 20, wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, is made of substantially flexible material.
28. The device according to claim 20, wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor is made of a biocompatible material, to promote tissue in-growth.
29. The device according to claim 20, wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor is coated by a biocompatible material, to promote tissue in-growth.
30. Device for deploying and anchoring a heart valve implant to a heart valve annulus of a heart valve of the heart of the body of a patient, the device being delivered to the heart valve annulus, by employing a catheter, the device comprising: at least one anterior heart tissue anchor, to be anchored to an anterior region of said heart valve annulus; at least one posterior heart tissue anchor, to be anchored to a posterior region of said heart valve annulus; and at least one elastic movement provider coupled with said at least one anterior heart tissue anchor, said at least one posterior heart tissue anchor and with a distal end of said catheter, said at least one elastic movement provider being in a folded configuration while being delivered by said catheter toward said heart valve, when in the vicinity of said heart valve, said at least one elastic movement provider moving from said folded configuration to a deployment configuration, simultaneously moving said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward said heart valve annulus, to position and to anchor said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, simultaneously, to said heart valve annulus, said at least one elastic movement provider providing movement of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another.
31. The device according to claim 30, further comprising a sheath within which said catheter passes through, wherein said at least one elastic movement provider is stowed within said sheath in said folded configuration, while being delivered by said catheter toward said heart valve annulus, wherein said at least one elastic movement provider applies an expansion force against an inner wall of said sheath, while being delivered by said catheter toward said heart valve annulus, and wherein said expansion force forces said at least one elastic movement provider to move from said folded configuration to said deployment configuration, when said at least one elastic movement provider is moved out of said sheath.
32. The device according to claim 31 , wherein said at least one elastic movement provider comprises: a first hinge coupled with said at least one anterior heart tissue anchor and with a first distal end of said at least one elastic movement provider, said first hinge enabling said at least one anterior heart tissue anchor to rotate by approximately ninety degrees, about a first axis passing through said first hinge, said first axis being substantially perpendicular to a surface of said at least one elastic movement provider and to a longitudinal axis of said at least one elastic movement provider; a second hinge coupled with said at least one posterior heart tissue anchor and with a second distal end of said at least one elastic movement provider, said second hinge enabling said at least one posterior heart tissue anchor to rotate by approximately ninety 5 degrees, about a second axis passing through said second hinge, said second axis being substantially perpendicular to said surface and to said longitudinal axis; a first elastic element coupled with said first hinge and with said first distal end; and io a second elastic element coupled with said second hinge and with said second distal end, wherein said first hinge and said first elastic element enable said at least one anterior heart tissue anchor to be stowed within sheath in said folded configuration, i5 wherein said second hinge and said second elastic element enable said at least one posterior heart tissue anchor to be stowed within sheath in said folded configuration, wherein said first hinge and said first elastic element enable said at least one anterior heart tissue anchor to rotate by approximately
20 ninety degrees about said first hinge, when said at least one elastic movement provider moves from said folded configuration to said deployment configuration, and wherein said second hinge and said second elastic element enable said at least one posterior heart tissue anchor to rotate by
25 approximately ninety degrees about said second hinge, when said at least one elastic movement provider moves from said folded configuration to said deployment configuration.
33. The device according to claim 31 , further comprising a plurality of
30 elastic connectors coupled with said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, said elastic connectors providing movement of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, relative to said at least one elastic movement provider, wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, is made of a shape memory alloy, and wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, moves from an anchor folded configuration, when said at least one elastic movement provider is in said folded configuration, to an anchor deployment configuration, when said at least one elastic movement provider moves from said folded configuration to said deployment configuration, and when each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, is subjected to a selected temperature.
34. The device according to claim 33, wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, is in form of a self-expandable wire mesh.
35. The device according to claim 33, wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, is in form of a self-expandable wire.
36. The device according to claim 33, wherein said selected temperature is below a body temperature of said body of said patient.
37. The device according to claim 33, wherein said selected temperature is above a body temperature of said body of said patient.
38. The device according to claim 31 , further comprising a plurality of elastic connectors coupled with said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, said elastic connectors providing movement of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, relative to said at least one elastic movement provider, wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, is made of a flexible material, and wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, moves from an anchor folded configuration, when said at least one elastic movement provider is in said folded configuration, to an anchor deployment configuration, when said at least one elastic movement provider moves from said folded configuration to said deployment configuration.
39. The device according to claim 30, further comprising: a sheath within which said catheter passes through; and an expander coupled with said distal end, wherein said at least one elastic movement provider is stowed within said sheath in said folded configuration, while being delivered by said catheter toward said heart valve annulus, said expander forcing said at least one elastic movement provider from said folded configuration to said deployment configuration, when said at least one elastic movement provider is moved out of said sheath.
40. The device according to claim 39, wherein said expander is in form of an inflatable balloon.
41. The device according to claim 39, wherein said expander is made of a shape memory alloy, which expands when subjected to a selected temperature.
5 42. The device according to claim 41 , wherein said selected temperature is below a body temperature of said body of said patient.
43. The device according to claim 41 , wherein said selected temperature is above a body temperature of said body of said patient.
10
44. The device according to claim 39, wherein said expander is made of an elastic material.
45. The device according to claim 30, wherein each of said at least one i5 anterior heart tissue anchor and said at least one posterior heart tissue anchor, includes a heart tissue assembly, said heart tissue assembly comprising: a male portion including a plurality of protrusions coupled at an oblique angle, to a male portion surface of said male portion; and
20 a female portion slidably coupled with said male portion, said female portion including a plurality of perforations, the quantity, diameter, and location of said protrusions matching those of said protrusions, the contour of said male portion surface matching a female portion surface of said female portion, and
25 wherein said male portion moves relative to said female portion, after said at least one elastic movement provider moves from said folded configuration to said deployment configuration, said protrusions protruding said perforations, said protrusions piercing the tissue of said heart valve annulus, to anchor said at least one anterior
30 heart tissue anchor and said at least one posterior heart tissue anchor, to said heart valve annulus.
46. The device according to claim 30, further comprising: a displacement reduction mechanism coupled with at least one of said catheter, and said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, said displacement reduction mechanism enabling irreversible movement of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, to a selected position, after said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, are anchored to said heart valve annulus; and at least one position fixation mechanism coupled with at least one of said catheter, and said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor, said at least one position fixation mechanism enabling irreversible fixation of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, at said selected position.
47. The device according to claim 46, wherein said displacement reduction mechanism comprises at least one thread coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor, said at least one thread passing through said catheter, from a distal end thereof to a proximal end thereof located external to said body of said patient, and wherein said displacement reduction mechanism provides said irreversible movement by enabling pulling of said at least one thread through said catheter.
48. The device according to claim 47, wherein said at least one position fixation mechanism comprises: a clamp coupled with a distal end of said catheter; and a thread coupled with said clamp, said thread passing through said catheter from said distal end to a proximal end of said catheter, wherein said at least one position fixation mechanism provides said irreversible fixation, by enabling pulling of said thread through said catheter and closing said clamp on said at least one thread.
49. The device according to claim 46, wherein said at least one position fixation mechanism comprises: a plurality of perforations located on said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor; and a plurality of protrusions located on said at least one elastic movement provider, the quantity, size, and location of said protrusions matching those of said perforations, said protrusions to be engaged with respective ones of said perforations, each of said protrusions having a saw-tooth form, to enable said irreversible fixation.
50. The device according to claim 46, further comprising an energy converter coupled with said displacement reduction mechanism, wherein said displacement reduction mechanism comprises at least one shape memory element, said at least one shape memory element being coupled with at least one of said at least one elastic movement provider, and said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, wherein said energy converter converts an electromagnetic radiation emitted by an energy source to heat, wherein said energy source is located external to said heart, wherein said energy converter transfers said heat to said displacement reduction mechanism, wherein the temperature of said at least one shape memory element changes due to said heat, wherein the shape of said at least one shape memory element changes due to said change in said temperature, and wherein said at least one shape memory applies a force on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, due to said change in said shape, to move said at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another.
51. The device according to claim 50, wherein said energy converter is in form of a coating which coats said displacement reduction mechanism.
52. The device according to claim 50, wherein said energy converter is integrated with said displacement reduction mechanism.
53. The device according to claim 46, further comprising an energy converter coupled with said displacement reduction mechanism, wherein said displacement reduction mechanism comprises at least one shape memory element coupled with at least one of said at least one elastic movement provider, and with said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, wherein said energy converter converts an acoustic energy emitted by an energy source to heat, wherein said energy source is located external to said heart, wherein said energy converter transfers said heat to said displacement reduction mechanism, wherein the temperature of said at least one shape memory element changes due to said heat, wherein the shape of said at least one shape memory element changes due to said change in said temperature, and
5 wherein said at least one shape memory applies a force on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, due to said change in said shape, to move said at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward io one another.
54. The device according to claim 46, further comprising an energy converter coupled with said displacement reduction mechanism, wherein said displacement reduction mechanism comprises at i5 least one shape memory element coupled with at least one of said at least one elastic movement provider, and with said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, wherein said energy converter converts an electromagnetic 20 radiation emitted by an energy source to an electric current, wherein said energy source is located external to said heart, wherein said energy converter transfers said electric current to said displacement reduction mechanism, wherein the temperature of said at least one shape memory 25 element changes due to said electric current, wherein the shape of said at least one shape memory element changes due to said change in said temperature, and wherein said at least .one shape memory applies a force on said at least one anterior heart tissue anchor and on said at least one
30 posterior heart tissue anchor, due to said change in shape, to move said at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another.
55. The device according to claim 46, wherein said displacement reduction mechanism comprises: at least one actuator coupled with at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor; and a flexible connector coupled with said at least one actuator, wherein said at least one actuator converts an electromagnetic radiation emitted by an energy source to heat, wherein said energy source is located external to said heart, and wherein said at least one actuator converts said heat to mechanical motion, to move said at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, via said flexible connector.
56. The device according to claim 55, wherein said mechanical motion is rotary.
57. The device according to claim 55, wherein said mechanical motion is linear.
58. The device according to claim 46, wherein said displacement 5 reduction mechanism comprises: at least one actuator coupled with at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor; and a flexible connector coupled with said at least one actuator, o wherein said at least one actuator converts an electromagnetic radiation emitted by an energy source to an electric current, wherein said energy source is located external to said heart, and wherein said at least one actuator converts said electric current to mechanical motion, to move said at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, via said flexible connector.
59. The device according to claim 46, wherein said displacement reduction mechanism comprises: at least one actuator coupled with at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor; and a flexible connector coupled with said at least one actuator, wherein said at least one actuator converts an acoustic energy emitted by an energy source, to mechanical motion, to move said at least one of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, via said flexible connector, and wherein said energy source is located external to said heart.
60. The device according to claim 30, wherein said at least one elastic movement provider is made from a material selected from the list consisting of: metal leaf spring; polymer; and shape memory alloy.
61. The device according to claim 30, wherein a central portion of said at least one elastic movement provider is substantially rigid in a central portion thereof, and substantially flexible at distal ends thereof.
62. The device according to claim 30, wherein said at least one elastic movement provider is substantially elastic along a longitudinal axis thereof.
63. The device according to claim 30, wherein said at least one elastic movement provider is made of a biocompatible material, to inhibit tissue in-growth.
64. The device according to claim 30, wherein said at least one elastic movement provider is coated by a biocompatible material, to inhibit tissue in-growth.
65. The device according to claim 30, wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor is made of a biocompatible material, to promote tissue in-growth.
66. The device according to claim 30, wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor is coated by a biocompatible material, to promote tissue in-growth.
67. Method for reducing the antero-posterior diameter of a heart valve annulus of a heart valve of the heart of the body of a patient, the method comprising the procedures of: anchoring at least one anterior heart tissue anchor of a heart valve implant, to an anterior region of said heart valve annulus; anchoring at least one posterior heart tissue anchor of said heart valve implant, to a posterior region of said heart valve annulus; and reducing the displacement between said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor to a selected value, irreversibly, by exposing said heart valve implant to an energy emitted by an energy source located external to said heart, to move said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another.
68. The method according to claim 67, further comprising a preliminary procedure of delivering said heart valve implant toward said heart valve.
69. The method according to claim 68, wherein said procedure of delivering comprises the sub-procedures of: coupling said heart valve implant to a distal end of a catheter; moving said heart valve implant to a folded configuration, within a sheath encompassing said catheter; and passing said catheter through said sheath, toward said heart valve.
70. The method according to claim 69, further comprising a procedure of moving said heart valve implant from said folded configuration to a deployment configuration.
71. The method according to claim 70, wherein said procedures of anchoring are performed simultaneously.
72. The method according to claim 70, wherein said procedure of moving said heart valve implant from said folded configuration to said deployment configuration, is performed by moving said heart valve implant out of said sheath; and inflating an inflatable balloon coupled with said distal end.
73. The method according to claim 70, wherein said procedure of moving said heart valve implant from said folded configuration to said deployment configuration, is performed by moving said heart valve implant out of said sheath; and subjecting a shape memory element coupled with said distal end, to a selected temperature.
74. The method according to claim 73, wherein said selected temperature is below a body temperature of said body of said patient.
75. The method according to claim 73, wherein said selected temperature is above a body temperature of said body of said patient.
76. The method according to claim 70, wherein said procedure of moving said heart valve implant to said folded configuration, includes a sub-procedure of coupling an elastic element to said distal end, said elastic element applying an expansion force on said heart valve implant, said expansion force forcing said heart valve implant against an inner wall of said sheath.
77. The method according to claim 76, wherein said procedure of moving said heart valve implant from said folded configuration to said deployment configuration, is performed by moving said heart valve implant out of said sheath.
78. The method according to claim 69, wherein said procedure of moving comprises a sub-procedure of folding each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, to an anchor folded configuration within sheath, by rotating said at least one anterior heart tissue anchor, by approximately ninety degrees, about a first axis passing through a first distal end of at least one elastic movement provider, coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor together, said first axis being substantially perpendicular to a surface of said at least one elastic movement provider and to a longitudinal axis of said at least one elastic movement provider; and by rotating said at least one posterior heart tissue anchor, by approximately ninety degrees about a second axis passing through a second distal end of said at least one elastic movement provider, said second axis being substantially perpendicular to said surface and to said longitudinal axis.
79. The method according to claim 78, further comprising a procedure of moving each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, from said anchor folded configuration to an anchor deployment configuration, by moving said heart valve implant out of said sheath; rotating said at least one anterior heart tissue anchor, about said first axis, by approximately ninety degrees; and rotating said at least one posterior heart tissue anchor, about said second axis, by approximately ninety degrees.
80. The method according to claim 69, wherein said procedure of moving comprises a sub-procedure of folding each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, to an anchor folded configuration within sheath, at a predetermined temperature.
81. The method according to claim 80, further comprising a procedure of moving each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, from said anchor folded configuration to an anchor deployment configuration, by moving said heart valve implant out of said sheath; and subjecting each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, to a selected temperature.
82. The method according to claim 81 , wherein said selected temperature is below a body temperature of said body of said patient.
83. The method according to claim 81 , wherein said selected temperature is above a body temperature of said body of said patient.
84. The method according to claim 69, wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, is made of an elastic material.
85. The method according to claim 84, wherein said procedure of moving comprises a sub-procedure of folding each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, to an anchor folded configuration within sheath.
86. The method according to claim 85, further comprising a procedure of moving each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, from said anchor folded configuration to an anchor deployment configuration, by moving said heart valve implant out of said sheath.
87. The method according to claim 68, wherein said procedure of delivering is performed in a percutaneous transluminal catheter delivery procedure.
88. The method according to claim 68, wherein said procedure of delivering is performed in a minimal invasive catheter delivery procedure.
89. The method according to claim 68, wherein said procedure of delivering is performed during an open heart surgery.
90. The method according to claim 67, wherein each of said procedures of anchoring is performed by employing an adhesive.
91. The method according to claim 67, wherein each of said procedures of anchoring is performed by employing a vacuum.
92. The method according to claim 67, wherein each of said procedures of anchoring is performed by employing a suturing procedure.
93. The method according to claim 67, wherein each of said procedures of anchoring is performed by employing at least one staple.
94. The method according to claim 67, further comprising a procedure of fixing said at least one anterior heart tissue anchor and said at least one posterior anchor, at said selected value.
95. The method according to claim 67, wherein said energy is in form of electromagnetic radiation.
96. The method according to claim 95, wherein said procedure of reducing comprises the sub-procedures of: converting said electromagnetic radiation to heat; and converting said heat to mechanical motion.
97. The method according to claim 95, wherein said procedure of reducing comprises the sub-procedures of: converting said electromagnetic radiation to electric current; and converting said electric current to mechanical motion.
98. The method according to claim 67, wherein said energy is in form of acoustic energy.
99. The method according to claim 98, wherein said procedure of reducing comprises the sub-procedures of: converting said acoustic energy to heat; and converting said heat to mechanical motion.
100. The method according to claim 98, wherein said procedure of reducing comprises the sub-procedure of converting said acoustic energy to mechanical motion.
101. Method for reducing the antero-posterior diameter of a heart valve annulus of a heart valve of the heart of the body of a patient, the method comprising the procedures of: anchoring at least one anterior heart tissue anchor of a heart valve implant, to an anterior region of said heart valve annulus; anchoring at least one posterior heart tissue anchor of said heart valve implant, to a posterior region of said heart valve annulus; and reducing the displacement between said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, over time, as a displacement reduction mechanism exhibits degradation.
102. The method according to claim 101 , further comprising a preliminary procedure of delivering said heart valve implant toward said heart valve.
103. The method according to claim 102, wherein said procedure of delivering comprises the sub-procedures of: coupling said heart valve implant to a distal end of a catheter; moving said heart valve implant to a folded configuration, within a sheath encompassing said catheter; and passing said catheter through said sheath, toward said heart valve.
104. The method according to claim 103, further comprising a procedure of moving said heart valve implant from said folded configuration to a deployment configuration.
105. The method according to claim 104, wherein said procedures of anchoring are performed simultaneously.
106. The method according to claim 104, wherein said procedure of moving said heart valve implant from said folded configuration to said deployment configuration, is performed by moving said heart valve implant out of said sheath; and inflating an inflatable balloon coupled with said distal end.
107. The method according to claim 104, wherein said procedure of moving said heart valve implant from said folded configuration to said deployment configuration, is performed by moving said heart valve implant out of said sheath; and subjecting a shape memory element coupled with said distal end, to a selected temperature.
108. The method according to claim 107, wherein said selected temperature is below a body temperature of said body of said patient.
5 109. The method according to claim 107, wherein said selected temperature is above a body temperature of said body of said patient.
110. The method according to claim 104, wherein said procedure of moving said heart valve implant to said folded configuration, includes io a sub-procedure of coupling an elastic element to said distal end, said elastic element applying an expansion force on said heart valve implant, said expansion force forcing said heart valve implant against an inner wall of said sheath.
i5 111. The method according to claim 110, wherein said procedure of moving said heart valve implant from said folded configuration to said deployment configuration, is performed by moving said heart valve implant out of said sheath.
20 112. The method according to claim 103, wherein said procedure of moving comprises a sub-procedure of folding each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, to an anchor folded configuration within sheath, by rotating said at least one anterior heart tissue anchor, by
25 approximately ninety degrees, about a first axis passing through a first distal end of at least one elastic movement provider, coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor together, said first axis being substantially perpendicular to a surface of said at least one elastic
30 movement provider and to a longitudinal axis of said at least one elastic movement provider; and by rotating said at least one posterior heart tissue anchor, by approximately ninety degrees about a second axis passing through a second distal end of said at least one elastic movement provider, said second axis being substantially perpendicular to said surface and to said longitudinal axis.
113. The method according to claim 112, further comprising a procedure of moving each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, from said anchor folded configuration to an anchor deployment configuration, by moving said heart valve implant out of said sheath; rotating said at least one anterior heart tissue anchor, about said first axis, by approximately ninety degrees; and rotating said at least one posterior heart tissue anchor, about said second axis, by approximately ninety degrees.
114. The method according to claim 103, wherein said procedure of moving comprises a sub-procedure of folding each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, to an anchor folded configuration within sheath, at a predetermined temperature.
115. The method according to claim 114, further comprising a procedure of moving each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, from said anchor folded configuration to an anchor deployment configuration, by moving said heart valve implant out of said sheath; and subjecting each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, to a selected temperature.
116. The method according to claim 115, wherein said selected temperature is below a body temperature of said body of said patient.
117. The method according to claim 115, wherein said selected 5 temperature is above a body temperature of said body of said patient.
118. The method according to claim 103, wherein each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, is made of an elastic material. 0
119. The method according to claim 118, wherein said procedure of moving comprises a sub-procedure of folding each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, to an anchor folded configuration within sheath. 5
120. The method according to claim 119, further comprising a procedure of moving each of said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, from said anchor folded configuration to an anchor deployment configuration, by o moving said heart valve implant out of said sheath.
121. The method according to claim 102, wherein said procedure of delivering is performed in a percutaneous transluminal catheter delivery procedure. 5
122. The method according to claim 102, wherein said procedure of delivering is performed in a minimal invasive catheter delivery procedure.
0 123. The method according to claim 102, wherein said procedure of delivering is performed during an open heart surgery.
124. The method according to claim 101 , wherein each of said procedures of anchoring is performed by employing an adhesive.
5 125. The method according to claim 101 , wherein each of said procedures of anchoring is performed by employing a vacuum.
126. The method according to claim 101 , wherein each of said procedures of anchoring is performed by employing a suturing procedure.
10
127. The method according to claim 101 , wherein each of said procedures of anchoring is performed by employing at least one staple.
128. The method according to claim 101 , further comprising a procedure i5 of fixing said at least one anterior heart tissue anchor and said at least one posterior anchor, at said selected value.
129. The method according to claim 101 , wherein said procedure of reducing comprises the sub-procedure of applying at least one
20 permanent force on each of said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, to move said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, and wherein at least one degradable portion of said displacement
25 reduction mechanism, applies a temporary force, on said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, in a direction opposite to that of said permanent force.
130. Method for reducing the antero-posterior diameter of a heart valve 30 annulus of a heart valve of the heart of the body of a patient, the method comprising the procedures of: passing a catheter through said body of said patient, toward said heart valve annulus, after completion of a procedure for implanting a heart valve implant in said heart, said heart valve implant including a displacement reduction mechanism, at least one anterior heart tissue
5 anchor, and at least one posterior heart tissue anchor, said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, being anchored to said heart valve annulus, said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, being coupled with said displacement reduction io mechanism; coupling a distal end of said catheter with said displacement reduction mechanism; and reducing the displacement between said at least one anterior heart tissue anchor and said at least one posterior heart tissue i5 anchor, irreversibly, to a selected value, by manipulating said distal end, and by activating said displacement reduction mechanism.
131. The method according to claim 130, further comprising a preliminary procedure of implanting said heart valve implant.
20
132. The method according to claim 131 , wherein said procedure of implanting is performed in a percutaneous transluminal catheter delivery procedure.
25 133. The method according to claim 131 , wherein said procedure of implanting is performed in a minimal invasive catheter delivery procedure.
134. The method according to claim 131 , wherein said procedure of 30 implanting is performed during an open heart surgery.
135. The method according to claim 130, further comprising a procedure of fixing said relaxed displacement at said selected value.
136. Method for anchoring a heart valve implant to a heart valve annulus of a heart valve of the heart of the body of a patient, and for reducing the antero-posterior diameter of the heart valve annulus, the method comprising the procedures of: applying a first force on at least one anterior heart tissue anchor of said heart valve implant, and on at least one posterior heart tissue anchor of said heart valve implant, in a first direction substantially normal to a tissue of said heart, to which said at least one anterior heart tissue and said at least one posterior heart tissue are anchored; applying a second force on at least one of said at least one anterior heart tissue anchor and on said at least one posterior heart tissue anchor, in a second direction away from said first direction, and toward the center of said heart valve annulus, to move said at least one anterior heart tissue anchor and said at least one posterior heart tissue anchor, toward one another, to a selected position, wherein said procedures of applying said first force and applying said second force, are performed simultaneously.
137. The method according to claim 136, wherein said procedure of applying said first force, is performed by inflating an inflatable balloon coupled with a distal end of a catheter, wherein said heart valve implant is coupled with said distal end, wherein said heart valve implant is folded in a folded configuration, within a sheath through which said catheter passes, wherein said catheter and said sheath are passed through said body of said patient, toward said heart valve, and wherein said heart valve implant is moved from said folded configuration to a deployment configuration, by moving said heart valve implant out of said sheath.
138. The method according to claim 136, wherein said procedure of applying said first force, is performed by changing the temperature of a shape memory element coupled with a distal end of a catheter, to a value different than that of said body of said patient, said catheter being passed through said body of said patient toward said heart valve, wherein said heart valve implant is coupled with said distal end, wherein said heart valve implant is folded in a folded configuration, within a sheath through which said catheter passes, and wherein said heart valve implant is moved from said folded configuration to a deployment configuration, by moving said heart valve implant out of said sheath.
139. The method according to claim 138, wherein said selected temperature is below a body temperature of said body of said patient.
140. The method according to claim 138, wherein said selected temperature is above a body temperature of said body of said patient.
141. The method according to claim 136, wherein said procedure of applying said second force is performed by pulling at least one thread, coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor.
142. The method according to claim 136, wherein said procedure of applying said second force comprises the sub-procedures of: exposing a displacement reduction mechanism of said heart valve implant, to an electromagnetic radiation, emitted by an energy source located external to said heart; converting said electromagnetic radiation to heat; and converting said heat to said second force, wherein said displacement reduction mechanism is coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor.
143. The method according to claim 136, wherein said procedure of applying said second force comprises the sub-procedures of: exposing a displacement reduction mechanism of said heart valve implant, to an electromagnetic radiation, emitted by an energy source located external to said heart; converting said electromagnetic radiation to electric current; and converting said electric current to said second force, wherein said displacement reduction mechanism is coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor.
144. The method according to claim 136, wherein said procedure of applying said second force comprises the sub-procedures of: exposing a displacement reduction mechanism of said heart valve implant, to an acoustic energy, emitted by an energy source located external to said heart; converting said acoustic energy to heat; and converting said heat to said second force, wherein said displacement reduction mechanism is coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor.
145. The method according to claim 136, wherein said procedure of applying said second force comprises the sub-procedures of: exposing a displacement reduction mechanism of said heart valve implant, to an acoustic energy, emitted by an energy source located external to said heart; and converting said acoustic energy to said second force, wherein said displacement reduction mechanism is coupled with said at least one anterior heart tissue anchor and with said at least one posterior heart tissue anchor.
146. Device for reducing the antero-posterior diameter of a heart valve annulus of a heart valve of the heart of the body of a patient, according to any of claims 1-29 substantially as described hereinabove.
147. Device for reducing the antero-posterior diameter of a heart valve annulus of a heart valve of the heart of the body of a patient, according to any of claims 1-29 substantially as illustrated in any of the drawings.
148. Device for deploying and anchoring a heart valve implant to a heart valve annulus of a heart valve of the heart of the body of a patient, according to any of claims 30-66 substantially as described hereinabove.
149. Device for deploying and anchoring a heart valve implant to a heart valve annulus of a heart valve of the heart of the body of a patient, according to any of claims 30-66 substantially as illustrated in any of the drawings.
150. Method for reducing the antero-posterior diameter of a heart valve annulus of a heart valve of the heart of the body of a patient, according to any of claims 67-135 substantially as described hereinabove.
151. Method for reducing the antero-posterior diameter of a heart valve annulus of a heart valve of the heart of the body of a patient, according to any of claims 67-135 substantially as illustrated in any of the drawings.
152. Method for anchoring a heart valve implant to a heart valve annulus of a heart valve of the heart of the body of a patient, according to any of claims 136-145 substantially as described hereinabove.
153. Method for anchoring a heart valve implant to a heart valve annulus of a heart valve of the heart of the body of a patient, according to any of claims 136-145 substantially as illustrated in any of the drawings.
PCT/IL2006/001040 2005-09-06 2006-09-06 Method and device for treatment of congestive heart failure and valve dysfunction WO2007029252A2 (en)

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WO2023232544A1 (en) 2022-06-02 2023-12-07 Mitralshape Apparatus and kit of parts for annuloplasty of the mitral valve

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