WO2009122412A1 - Device and method for remodeling a heart valve leaflet - Google Patents

Device and method for remodeling a heart valve leaflet Download PDF

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Publication number
WO2009122412A1
WO2009122412A1 PCT/IL2009/000363 IL2009000363W WO2009122412A1 WO 2009122412 A1 WO2009122412 A1 WO 2009122412A1 IL 2009000363 W IL2009000363 W IL 2009000363W WO 2009122412 A1 WO2009122412 A1 WO 2009122412A1
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WO
WIPO (PCT)
Prior art keywords
valve
leaflet
leaflets
catheter
previous
Prior art date
Application number
PCT/IL2009/000363
Other languages
French (fr)
Inventor
Daniel Levine
Original Assignee
Daniel Levine
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 Daniel Levine filed Critical Daniel Levine
Publication of WO2009122412A1 publication Critical patent/WO2009122412A1/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
    • A61F2/2454Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • 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
    • A61F2/2448D-shaped rings
    • 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
    • A61F2/2463Implants forming part of the valve leaflets
    • 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
    • A61F2250/0007Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting length

Definitions

  • This invention relates to medical devices and methods, and more particular to such devices and methods for treating a heart valve.
  • Fig. 1 shows the structure of a normal mitral valve 2.
  • the valve 2 has a mitral annulus 4 made of fibrous tissue that surrounds the valve that is generally saddle shaped having a major axis CD extending from medial to lateral aspects of the valve, and an anterior-posterior minor axis AB.
  • the mitral annulus which is a saddle shaped elliptical region with the anterior leaflet 6 and the posterior leaflet 8 oriented in a medial to lateral direction, and the orifice 10 between the leaflets 6 and 8 is substantially parallel to the major axis CD of the annulus.
  • the anterior leaflet is larger than the posterior leaflet.
  • the combined area of both leaflets is 2.5 times the annulus area and when the leaflets coapt the zone of leaflet apposition results in leaflet overlap.
  • a heart valve may become defective or damaged from degeneration caused by congenital malformation, disease, aging, etc.
  • One common problem associated with a degenerating heart valve is an enlargement. If the annulus of the mitral valve enlarges or dilates to a point where the leaflets are unable to fully close the opening (malcoaptation), the leaflets fail to overlap during systole to effectively stop blood flow, a condition known as "valve regurgitation". Furthermore, valve prolapse, or the forcing of the valve annulus and leaflets into the left atrium by backpressure during ventricle contraction, may occur.
  • Fig. 2 shows a regurgitant heart valve 21 in which the leaflets 6 and 8 fail to overlap during systole due to furling and sagging of the leaflets.
  • Furling of the leaflets 6 and 8 has occurred in a region 20 and 22, respectively located near the edge of the leaflets.
  • Sagging of the leaflets 6 and 8 has occurred in a region 24 and 26, respectively, of the leaflets. Due to the furling and sagging, the leaflets fail to overlap during systole so that a gap 23 is present between the leaflets at systole through which valve regurgitation occurs.
  • Adverse clinical symptoms such as chest pain, cardiac arrhythmias, dyspnea, may manifest in response to regurgitation or valve prolapse.
  • surgical correction either by valve repair procedures or by valve replacement, may be required.
  • Surgical reconstruction or repair procedures may include plication, chordal shortening, or chordal replacement.
  • Another common repair procedure relates to remodelling of the valve annulus (e.g., annuloplasty), which may be accomplished by implantation of a prosthetic ring to help stabilize the annulus and to correct or help prevent valve insufficiency which may result from a defect or dysfunction of the valve annulus.
  • Properly sizing and implanting an annuloplasty ring may substantially restore the valve annulus to its normal, undilated, circumference.
  • the annulus is deformed so that the length of the minor axis AB has increased from its normal length shown in Fig. 1. This lengthening of the minor axis increases the separation between the two leaflets, so that the two leaflets fail to overlap during systole.
  • a variety of repair techniques have been developed for tutoring a deformed annulus to decrease the minor axis so as to bring the leaflet edges closer together.
  • the Alfieri technique involves suturing the anterior and posterior leaflets together in the central section of the leaflets.
  • valve shield comprising a shaped sheet of material adapted to be affixed to the annulus of a valve and adapted to extend over at least a portion of at least one leaflet of the valve so as to assist or replace the closing function of that valve leaflet.
  • US Patent publication 20050004665 discloses implantable devices for the repair of a defective cardiac valve having an annuloplasty ring and a restraining or support structure or mechanism.
  • the annuloplasty ring functions to reestablish the normal size and shape of the annulus bringing the leaflet in proximity to each other.
  • the restraining structure functions to restrain the abnormal motion of at least a portion of the valve being repaired.
  • the restraining structure may include at least one restraining member across the interior of the circumference of the ring in a configuration consisting of a primary member to which secondary members are attached or one where all members traverse the ring.
  • US Patent Publication 20050075727 discloses a mitral valve prosthesis comprising flexible leaflet-like elements with curved coapting surfaces and means for maintaining continuity of the valve when inserted into the mitral annulus.
  • US Patent No. 7,160,322 discloses a device having a buttress extending from a base portion. The buttress permits flow of blood when the valve leaflets are not engaging the buttress.
  • the present invention provides a device and method for treating a regurgitant heart valve that may be a mitral valve or a tricuspid valve.
  • the device of the invention comprises one or more slender portions.
  • the device of the invention is adapted to be affixed to one of the leaflets of a heart valve. As explained below, affixing the device of the invention onto to a valve leaflet tends to decrease or eliminate a gap between the leaflet edges due to furling or sagging of the leaflets, and thus tends to prevent or reduce prolapse of the leaflet.
  • the invention provides a device for remodeling a heart valve leaflet comprising a slender portion and being adapted to be affixed to the leaflet.
  • the invention provides use of the device of the invention for the treatment of valve regurgitation.
  • the invention further provides a catheter having a proximal end and a distal end configured for deploying a device of the invention.
  • Also provided by the invention is a method for remodeling a heart valve leaflet comprising affixing to the leaflet a device of the invention.
  • Fig. 1 shows a normal mitral valve
  • Fig. 2 shows a regurgitant heart valve
  • Fig. 3 shows a device for treating a regurgitant heart valve in accordance with one embodiment of the invention
  • Fig. 4 shows a heart valve after deployment of several devices of the invention
  • Fig. 5 shows a device for treating a regurgitant heart valve in accordance with another embodiment of the invention
  • Fig. 6 shows a device for treating a regurgitant heart valve having an unstrained configuration (Fig. 6a) and a strained configuration (Fig. 6b) in accordance with yet another embodiment of the invention
  • Fig. 7 shows the device of Fig. 6 after deployment in a heart valve
  • Fig. 8 shows a catheter for delivering and deploying a device of the invention
  • Fig. 9 shows the catheter of Fig. 8 with a device of the invention mounted on the distal end of the catheter;
  • Fig. 10 shows a device for treating a regurgitant heart valve in accordance with another embodiment of the invention having an unstrained configuration (Fig. 10a) and a strained configuration (Fig. 10b); and
  • Fig. 11 shows the device of Fig. 10 after deployment in a heart valve.
  • Fig. 3 shows a device 32 for treating a regurgitant heart valve in accordance with one embodiment of the invention.
  • the device 32 comprises a slender portion 34, which may be straight, as shown in Fig. 3. Alternatively, the slender portion may be curved or looped, as shown below.
  • the slender portion 34 may be rigid or elastic, as required in any application.
  • At each end of the shaft is an eyelet 36 that serves for suturing the device 32 to a valve leaflet, as explained below.
  • the device 32 is made from a biocompatible rigid material, such as metal, plastic, Nitinol or synthetic collagen.
  • the device 32 is deployed using a suturing catheter having a distal end adapted to mounting a device of the invention.
  • the device 32 may be provided with angiographically visible markers 33 for assistance in positioning the device during deployment.
  • mitral regurgitation can be monitored by echocardiography, transesophageal echo-cardiography or Doppler cardiography.
  • the device of the invention may be deployed in any heart valve such as a mitral valve or a tricuspid valve.
  • Fig. 4 shows the heart valve 21 after deploying several devices 32 of the invention.
  • Three devices 32a, 32b, and 32c have been affixed to the leaflet 6 and three devices 32d, 32e, and 32f have been affixed to the leaflet 8.
  • the devices 32 have been affixed to the leaflets 6 and 8 in an orientation that is substantially perpendicular to the edge of the leaflets adjacent to the orifice 10 of the valve 21. Attachment of the devices 32 to the leaflets tends to reduce or eliminate furling and sagging of the leaflets.
  • any number of the devices 32 may be deployed on each leaflet as required in any application to reduce or eliminate furling and sagging of the leaflets.
  • the devices 32 have been sutured to the leaflet by sutures 40 at each eyelet 36. Affixing the devices 32 to the leaflets has reduced or eliminated furling and sagging of the leaflets, thereby returning to the leaflets their original conformation as shown in Fig. 1. In this conformation, the edges of the leaflets 6 and 8 are brought closer together so as to reduce or eliminate the gap 23 (Fig. 2). In this conformation, valve regurgitation is reduced or eliminated.
  • Fig. 5 shows a device 50 in accordance with another embodiment of the invention.
  • the device 50 has an elongated first section 52 and an elongated second section 54. At the end of the section 52 and 54 is an eyelet 56 for suturing the device 50 to a valve leaflet, as explained above with reference to Fig. 4.
  • the second section 54 has a lumen 58 dimensioned to receive the first section 52. The length of the device 50 may thus be selected as required in any application.
  • the device 50 is made from a biocompatible rigid material, such as metal, plastic, Nitinol or synthetic collagen.
  • Fig. 6 shows a device 62 in accordance with yet another embodiment of the invention.
  • the device 62 has an elongated shaft 64. Along the length of the shaft 64 are two or more eyelets 66 for suturing the device 62 to a valve leaflet.
  • the device 64 is made from an elastic material so that the shaft 64 is elastically deformable from a slightly curved, unstrained, configuration shown in Fig. 6a to strained configuration of higher curvature shown in Fig. 6b.
  • Fig. 7 shows the device 62 after deployment in the heart valve 21. The device 62 was strained into the high curvature configuration shown in Fig. 6b and then sutured to the leaflet 6 by sutures 68 at each of the eyelets 66.
  • the device 62 is thus affixed to the leaflet 6 in a strained configuration in an orientation substantially parallel to the edge of the valve adjacent to the orifice 10 of the valve. In this orientation, the device 62 tends to stretch the leaflet 6 and bring it closer to the leaflet 8 as the device 62 tends to curve back to the slightly curved configuration, as shown in Fig. 7. In this conformation, the edges of the leaflets 6 and 8 are brought closer together so as to reduce or eliminate the gap 23 (Fig. 2). In this conformation, valve regurgitation is reduced or eliminated.
  • Fig. 10 shows a device 92 in accordance with yet another embodiment of the invention.
  • the device 92 has a closed loop structure.
  • the device 92 is made from an elastic material so that the device 92 is elastically deformable from a slightly curved, unstrained, configuration shown in Fig. 1 Oa to strained configuration of higher curvature shown in Fig. 10b.
  • Fig. 11 shows the device 92 after deployment in the heart valve 21.
  • the device 92 has a closed loop structure.
  • the device 92 is made from an elastic material so that the device 92 is elastically deformable from a slightly curved, unstrained, configuration shown in Fig. 1 Oa to strained configuration of higher curvature shown in Fig. 10b.
  • Fig. 11 shows the device 92 after deployment in the heart valve 21.
  • the device 92 has a closed loop structure.
  • two or more eyelets 66 for suturing the device 62 to a valve leaflet.
  • the device 92 is made from an elastic material
  • FIGS. 8 and 9 show a catheter 70 for delivering and deploying a device of the invention in an atrium adjacent to a mitral valve to be treated by the device.
  • the catheter 70 has a slender flexible shaft 72 having a proximal end 74 and a distal end 76.
  • the distal end 76 is configured to have mounted upon it a device of the invention for treating a mitral valve.
  • Fig. 9 shows the device 50 mounted on the distal end 76 of the catheter 70. This is by way of -example only, and the distal end 76 can be adapted to mount any device of the invention for treating a mitral valve.
  • a control wire 80 extends along the interior of the shaft from the proximal end to the distal end that allows an operator to release the device 50 from the distal end 76 when the device 50 is deployed adjacent to a mitral valve.
  • the distal end is also provided with a suture assembly 78 for suturing the device 50 at the site of deployment of the device.
  • the suture assembly may be used with spring sutures or cords.
  • the distal end 76 of the catheter 70 may be delivered to the mitral valve via a transseptal approach.

Abstract

The invention provides a device for remodeling a heart valve leaflet such as a mitral valve leaflet or a tricuspid valve in the treatment of valve regurgitation. The device has a slender portion (34) adapted to be affixed to the leaflet. In one embodiment, the device is provided with one or more eyelets for affixing to the leaflet by suturing. The slender portion may be straight or curved, rigid or elastic. The invention also provides a catheter for deploying a device of the invention

Description

DEVICE AND METHOD FOR REMODELING A HEART VALVE
LEAFLET
FIELD OF THE INVENTION
This invention relates to medical devices and methods, and more particular to such devices and methods for treating a heart valve.
BACKGROUND OF THE INVENTION
Fig. 1 shows the structure of a normal mitral valve 2. The valve 2 has a mitral annulus 4 made of fibrous tissue that surrounds the valve that is generally saddle shaped having a major axis CD extending from medial to lateral aspects of the valve, and an anterior-posterior minor axis AB. The mitral annulus which is a saddle shaped elliptical region with the anterior leaflet 6 and the posterior leaflet 8 oriented in a medial to lateral direction, and the orifice 10 between the leaflets 6 and 8 is substantially parallel to the major axis CD of the annulus. I
The anterior leaflet is larger than the posterior leaflet. The combined area of both leaflets is 2.5 times the annulus area and when the leaflets coapt the zone of leaflet apposition results in leaflet overlap. Thus, when a heart valve functions properly, the valve prevents regurgitation of blood from the ventricle into the atrium when the ventricle contracts. In order to withstand the substantial backpressure and prevent regurgitation of blood into the left atrium during the ventricular contraction, the cordae tendinae hold the anterior and posterior leaflets in place across the opening of the annulus ring. The cordae tendinae are fibrous cords that anchor the leaflets to the muscular wall of the heart and thus control the movement of the leaflets.
A heart valve may become defective or damaged from degeneration caused by congenital malformation, disease, aging, etc. One common problem associated with a degenerating heart valve is an enlargement. If the annulus of the mitral valve enlarges or dilates to a point where the leaflets are unable to fully close the opening (malcoaptation), the leaflets fail to overlap during systole to effectively stop blood flow, a condition known as "valve regurgitation". Furthermore, valve prolapse, or the forcing of the valve annulus and leaflets into the left atrium by backpressure during ventricle contraction, may occur.
Fig. 2 shows a regurgitant heart valve 21 in which the leaflets 6 and 8 fail to overlap during systole due to furling and sagging of the leaflets. Furling of the leaflets 6 and 8 has occurred in a region 20 and 22, respectively located near the edge of the leaflets. Sagging of the leaflets 6 and 8 has occurred in a region 24 and 26, respectively, of the leaflets. Due to the furling and sagging, the leaflets fail to overlap during systole so that a gap 23 is present between the leaflets at systole through which valve regurgitation occurs.
Adverse clinical symptoms, such as chest pain, cardiac arrhythmias, dyspnea, may manifest in response to regurgitation or valve prolapse. As a result, surgical correction, either by valve repair procedures or by valve replacement, may be required. Surgical reconstruction or repair procedures may include plication, chordal shortening, or chordal replacement. Another common repair procedure relates to remodelling of the valve annulus (e.g., annuloplasty), which may be accomplished by implantation of a prosthetic ring to help stabilize the annulus and to correct or help prevent valve insufficiency which may result from a defect or dysfunction of the valve annulus. Properly sizing and implanting an annuloplasty ring may substantially restore the valve annulus to its normal, undilated, circumference.
In one type of valve deformation, the annulus is deformed so that the length of the minor axis AB has increased from its normal length shown in Fig. 1. This lengthening of the minor axis increases the separation between the two leaflets, so that the two leaflets fail to overlap during systole. A variety of repair techniques have been developed for tutoring a deformed annulus to decrease the minor axis so as to bring the leaflet edges closer together. The Alfieri technique, involves suturing the anterior and posterior leaflets together in the central section of the leaflets. Other methods include mitral valve repair with left ventricle remodeling and reshaping techniques to re-orient the papillary muscles and the chordae and leaflets such that the approximation of the edges improves and closure of the valve is obtained. US Patent Publication discloses a valve shield comprising a shaped sheet of material adapted to be affixed to the annulus of a valve and adapted to extend over at least a portion of at least one leaflet of the valve so as to assist or replace the closing function of that valve leaflet.
US Patent publication 20050004665 discloses implantable devices for the repair of a defective cardiac valve having an annuloplasty ring and a restraining or support structure or mechanism. The annuloplasty ring functions to reestablish the normal size and shape of the annulus bringing the leaflet in proximity to each other. The restraining structure functions to restrain the abnormal motion of at least a portion of the valve being repaired. The restraining structure may include at least one restraining member across the interior of the circumference of the ring in a configuration consisting of a primary member to which secondary members are attached or one where all members traverse the ring.
US Patent Publication 20050075727 discloses a mitral valve prosthesis comprising flexible leaflet-like elements with curved coapting surfaces and means for maintaining continuity of the valve when inserted into the mitral annulus.
US Patent No. 7,160,322 discloses a device having a buttress extending from a base portion. The buttress permits flow of blood when the valve leaflets are not engaging the buttress.
SUMMARY OF THE INVENTION
In its first aspect, the present invention provides a device and method for treating a regurgitant heart valve that may be a mitral valve or a tricuspid valve. The device of the invention comprises one or more slender portions. The device of the invention is adapted to be affixed to one of the leaflets of a heart valve. As explained below, affixing the device of the invention onto to a valve leaflet tends to decrease or eliminate a gap between the leaflet edges due to furling or sagging of the leaflets, and thus tends to prevent or reduce prolapse of the leaflet.
Thus, in its first aspect, the invention provides a device for remodeling a heart valve leaflet comprising a slender portion and being adapted to be affixed to the leaflet.
In another of its aspects, the invention provides use of the device of the invention for the treatment of valve regurgitation. The invention further provides a catheter having a proximal end and a distal end configured for deploying a device of the invention.
Also provided by the invention is a method for remodeling a heart valve leaflet comprising affixing to the leaflet a device of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
In order to understand the invention and to see how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:
Fig. 1 shows a normal mitral valve;
Fig. 2 shows a regurgitant heart valve;
Fig. 3 shows a device for treating a regurgitant heart valve in accordance with one embodiment of the invention;
Fig. 4 shows a heart valve after deployment of several devices of the invention;
Fig. 5 shows a device for treating a regurgitant heart valve in accordance with another embodiment of the invention;
Fig. 6 shows a device for treating a regurgitant heart valve having an unstrained configuration (Fig. 6a) and a strained configuration (Fig. 6b) in accordance with yet another embodiment of the invention;
Fig. 7 shows the device of Fig. 6 after deployment in a heart valve;
Fig. 8 shows a catheter for delivering and deploying a device of the invention;
Fig. 9 shows the catheter of Fig. 8 with a device of the invention mounted on the distal end of the catheter;
Fig. 10 shows a device for treating a regurgitant heart valve in accordance with another embodiment of the invention having an unstrained configuration (Fig. 10a) and a strained configuration (Fig. 10b); and
Fig. 11 shows the device of Fig. 10 after deployment in a heart valve.
DETAILED DESCRIPTION OF EMBODIMENTS
Fig. 3 shows a device 32 for treating a regurgitant heart valve in accordance with one embodiment of the invention. The device 32 comprises a slender portion 34, which may be straight, as shown in Fig. 3. Alternatively, the slender portion may be curved or looped, as shown below. The slender portion 34 may be rigid or elastic, as required in any application. At each end of the shaft is an eyelet 36 that serves for suturing the device 32 to a valve leaflet, as explained below. The device 32 is made from a biocompatible rigid material, such as metal, plastic, Nitinol or synthetic collagen. The device 32 is deployed using a suturing catheter having a distal end adapted to mounting a device of the invention. The device 32 may be provided with angiographically visible markers 33 for assistance in positioning the device during deployment. During deployment of the device of the invention, mitral regurgitation can be monitored by echocardiography, transesophageal echo-cardiography or Doppler cardiography.
The device of the invention may be deployed in any heart valve such as a mitral valve or a tricuspid valve. Fig. 4 shows the heart valve 21 after deploying several devices 32 of the invention. Three devices 32a, 32b, and 32c have been affixed to the leaflet 6 and three devices 32d, 32e, and 32f have been affixed to the leaflet 8. The devices 32 have been affixed to the leaflets 6 and 8 in an orientation that is substantially perpendicular to the edge of the leaflets adjacent to the orifice 10 of the valve 21. Attachment of the devices 32 to the leaflets tends to reduce or eliminate furling and sagging of the leaflets. Any number of the devices 32 may be deployed on each leaflet as required in any application to reduce or eliminate furling and sagging of the leaflets. The devices 32 have been sutured to the leaflet by sutures 40 at each eyelet 36. Affixing the devices 32 to the leaflets has reduced or eliminated furling and sagging of the leaflets, thereby returning to the leaflets their original conformation as shown in Fig. 1. In this conformation, the edges of the leaflets 6 and 8 are brought closer together so as to reduce or eliminate the gap 23 (Fig. 2). In this conformation, valve regurgitation is reduced or eliminated.
Fig. 5 shows a device 50 in accordance with another embodiment of the invention. The device 50 has an elongated first section 52 and an elongated second section 54. At the end of the section 52 and 54 is an eyelet 56 for suturing the device 50 to a valve leaflet, as explained above with reference to Fig. 4. The second section 54 has a lumen 58 dimensioned to receive the first section 52. The length of the device 50 may thus be selected as required in any application. After adjusting the device 50 to a desired length with two rows of diametrically apposed apertures 60 on the first section 52 aligned with two rows of diametrically apposed apertures 63 on the second section 54, the length of the device is fixed by suturing though the aligned apertures 58 and 60. The device 50 is made from a biocompatible rigid material, such as metal, plastic, Nitinol or synthetic collagen.
Fig. 6 shows a device 62 in accordance with yet another embodiment of the invention. The device 62 has an elongated shaft 64. Along the length of the shaft 64 are two or more eyelets 66 for suturing the device 62 to a valve leaflet. The device 64 is made from an elastic material so that the shaft 64 is elastically deformable from a slightly curved, unstrained, configuration shown in Fig. 6a to strained configuration of higher curvature shown in Fig. 6b. Fig. 7 shows the device 62 after deployment in the heart valve 21. The device 62 was strained into the high curvature configuration shown in Fig. 6b and then sutured to the leaflet 6 by sutures 68 at each of the eyelets 66. The device 62 is thus affixed to the leaflet 6 in a strained configuration in an orientation substantially parallel to the edge of the valve adjacent to the orifice 10 of the valve. In this orientation, the device 62 tends to stretch the leaflet 6 and bring it closer to the leaflet 8 as the device 62 tends to curve back to the slightly curved configuration, as shown in Fig. 7. In this conformation, the edges of the leaflets 6 and 8 are brought closer together so as to reduce or eliminate the gap 23 (Fig. 2). In this conformation, valve regurgitation is reduced or eliminated.
Fig. 10 shows a device 92 in accordance with yet another embodiment of the invention. The device 92 has a closed loop structure. Along the device 92 are two or more eyelets 66 for suturing the device 62 to a valve leaflet. The device 92 is made from an elastic material so that the device 92 is elastically deformable from a slightly curved, unstrained, configuration shown in Fig. 1 Oa to strained configuration of higher curvature shown in Fig. 10b. Fig. 11 shows the device 92 after deployment in the heart valve 21. The device
92 was strained into the high curvature configuration shown in Fig. 10b and then sutured to the leaflet 6 by sutures 68 at each of the eyelets 66. The device 92 is thus affixed to the leaflet 6 in a strained configuration which tends to stretch the leaflet 6 and bring it closer to the leaflet 8 as the device 92 tends to revert to the slightly curved configuration, as shown in Fig. 11. In this conformation, the edges of the leaflets 6 and 8 are brought closer together so as to reduce or eliminate the gap 23 (Fig. 2). In this conformation, valve regurgitation is reduced or eliminated. Figs. 8 and 9 show a catheter 70 for delivering and deploying a device of the invention in an atrium adjacent to a mitral valve to be treated by the device. The catheter 70 has a slender flexible shaft 72 having a proximal end 74 and a distal end 76. The distal end 76 is configured to have mounted upon it a device of the invention for treating a mitral valve. Fig. 9 shows the device 50 mounted on the distal end 76 of the catheter 70. This is by way of -example only, and the distal end 76 can be adapted to mount any device of the invention for treating a mitral valve. A control wire 80 extends along the interior of the shaft from the proximal end to the distal end that allows an operator to release the device 50 from the distal end 76 when the device 50 is deployed adjacent to a mitral valve. The distal end is also provided with a suture assembly 78 for suturing the device 50 at the site of deployment of the device. The suture assembly may be used with spring sutures or cords. The distal end 76 of the catheter 70 may be delivered to the mitral valve via a transseptal approach.

Claims

CLAIMS:
1. A device for remodeling a heart valve leaflet comprising a slender portion and being adapted to be affixed to the leaflet.
2. The device according to Claim 1 wherein the slender portion is straight.
3. The device according to Claim 2 being dimensioned and configured to be affixed to a valve leaflet in an orientation substantially perpendicular to an edge of the valve adjacent to an orifice of the valve.
4. The device according to any one of the previous claims having one or more eyelets.
5. The device according to any one of the previous claims comprising one or more angiographic markers.
6. The device according to any one of the previous claims adapted for affixing to the leaflet by suturing.
7. The device according to any one of the previous claims wherein the slender portion has an adjustable length.
8. The device according to Claim 7 comprising a first member and a second member, the first member having an interior configured to slidably receive a portion of the second member.
9. The device according to Claim 7 or 8 wherein the length of the device is fixed using one or more sutures.
10. The device according to any one of the previous claims, wherein the slender poriton is rigid.
11. The device according to any one of Claims 1 to 10 wherein the slender portion is elastic.
12. The device according to Claim 11 wherein the slender portion has a curved unstrained shape.
13. The device according to Claim 12 being dimensioned and configured to be affixed to a valve leaflet in an orientation substantially parallel to an edge of the valve adjacent to an orifice of the valve.
14. The device according to Claim 11 wherein the device has a closed loop structure.
15. Use of the device according to any one of the previous claims for the treatment of valve regurgitation.
16. A catheter having a proximal end and a distal end configured for deploying a device according to any one of the previous claims.
17. The catheter according to Claim 16 adapted for mounting a device according to any one of Claims 1 to 11 at the distal end of the catheter.
18. The catheter according to Claim 16 or 17 further comprising a suturing assembly at the distal end of the catheter.
19. A method for remodeling a heart valve leaflet comprising affixing to the leaflet a device according to any one of Claims 1 to 13.
20. The method according to Claim 19 comprising suturing the device to the leaflet.
PCT/IL2009/000363 2008-03-31 2009-04-05 Device and method for remodeling a heart valve leaflet WO2009122412A1 (en)

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US6485608P 2008-03-31 2008-03-31
US61/064,856 2008-03-31

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EP2785276A4 (en) * 2011-12-01 2015-08-12 Woodstock Man Pty Ltd Endoluminal prosthesis
CN105520792A (en) * 2016-02-02 2016-04-27 上海纽脉医疗科技有限公司 D-shaped invasive prosthetic heart valve
CN105726167A (en) * 2016-02-02 2016-07-06 上海纽脉医疗科技有限公司 Involved artificial heart valve prosthesis

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CN105520792A (en) * 2016-02-02 2016-04-27 上海纽脉医疗科技有限公司 D-shaped invasive prosthetic heart valve
CN105726167A (en) * 2016-02-02 2016-07-06 上海纽脉医疗科技有限公司 Involved artificial heart valve prosthesis

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