WO2003037171A9 - Focused compression mitral valve device and method - Google Patents
Focused compression mitral valve device and methodInfo
- Publication number
- WO2003037171A9 WO2003037171A9 PCT/US2002/035196 US0235196W WO03037171A9 WO 2003037171 A9 WO2003037171 A9 WO 2003037171A9 US 0235196 W US0235196 W US 0235196W WO 03037171 A9 WO03037171 A9 WO 03037171A9
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- force
- coronary sinus
- mitral valve
- expandable
- valve annulus
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2451—Inserts in the coronary sinus for correcting the valve shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1006—Balloons formed between concentric tubes
Definitions
- the present invention generally relates to a device and method for treating dilated cardiomyopathy of a heart.
- the present invention more particularly relates to a device and method for delivering a localized force to the mitral valve annulus to reshape the mitral valve annulus.
- the human heart generally includes four valves. Of these valves, a most critical one is known as the mitral valve.
- the mitral valve is located in the left atrial ventricular opening between the left atrium and left ventricle.
- the mitral valve is intended to prevent regurgitation of blood from the left ventricle into the left atrium when the left ventricle contracts . In preventing blood regurgitation the mitral valve must be able to withstand considerable back pressure as the left ventricle contracts.
- the valve cusps of the mitral valve are anchored to muscular wall of the heart by delicate but strong fibrous cords in order to support the cusps during left ventricular contraction. In a healthy mitral valve, the geometry of the mitral valve ensures that the cusps overlie each other to preclude regurgitation of the blood during left ventricular contraction.
- the normal functioning of the mitral valve in preventing regurgitation can be impaired by dilated cardiomyopathy caused by disease or certain natural defects.
- certain diseases may cause dilation of the mitral valve annulus. This can result in deformation of the mitral valve geometry to cause ineffective closure of the mitral valve during left ventricular contraction. Such ineffective closure results in leakage through the mitral valve and regurgitation.
- Diseases such as bacterial inflammations of the heart or heart failure can cause the aforementioned distortion or dilation of the mitral valve annulus. Needless to say, mitral valve regurgitation must not go uncorrected.
- One method of repairing a mitral valve having impaired function is to completely replace the valve.
- prostheses are annular or partially annular shaped members which fit about the base of the valve annulus.
- the annular or partially annular shaped members may be formed from a rigid material, such as a metal, or from a flexible material.
- the device includes a resilient member having a cross sectional dimension for being received within the coronary sinus of the heart and a longitudinal dimension having an unstressed arched configuration when placed in the coronary sinus.
- the device partially encircles and exerts an inward pressure on the mitral valve.
- the inward pressure constricts the mitral valve annulus, or at least a portion of it, to essentially restore the mitral valve geometry. This promotes effective valve sealing action and eliminates mitral regurgitation .
- the device may be implanted in the coronary sinus using only percutaneous techniques similar to the techniques used to implant cardiac leads such as pacemaker leads.
- One proposed system for implanting the device includes an elongated introducer configured for being releasably coupled to the device.
- the introducer is preferably flexible to permit it to advance the device into the heart and into the coronary sinus through the coronary sinus ostium.
- an elongated sheath is first advanced into the coronary sinus. Then, the device and introducer are moved through a lumen of the sheath until the device is in position within the coronary sinus. Because the device is formed of resilient material, it conforms to the curvatures of the lumen as it is advanced through the sheath.
- the sheath is then partially retracted to permit the device to assume its unstressed arched configuration.
- the introducer is then decoupled from the device and retracted through the sheath.
- the procedure is then completed by the retraction of the sheath.
- the device is left within the coronary sinus to exert the inward pressure on the mitral valve to restore mitral valve geometry.
- the human anatomy does impose some obstacles to this recently proposed procedure for treating mitral regurgitation. More specifically, the human heart includes a coronary artery which descends from the aorta. One branch of the coronary artery is the circumflex artery which, in turn, includes the left marginal branch of the circumflex artery. As used herein, the term "circumflex artery" is taken to include the circumflex artery itself or any branch therefrom.
- the circumflex artery extends distally generally along the coronary sinus but at a point proximal to the coronary artery, it passes under the coronary sinus.
- the circumflex artery supports blood flow important to the viability of the heart. Hence, reduction in this blood flow must be avoided.
- a device placed in the coronary sinus must not be permitted to extend within the coronary sinus beyond the crossover point of the circumflex artery and the coronary sinus in a way which impedes blood flow in the circumflex artery.
- the therapy still contemplates the general reshaping of the mitral valve annulus.
- the devices encircle more than half of the mitral valve annulus in an attempt to provide generalized mitral valve annulus reshaping. While this indeed may be successful, it may be unnecessary.
- the invention provides a mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus.
- the device includes a force applier that applies an applied force to a discrete portion of the atrial wall of the coronary sinus adjacent to the mitral valve annulus to concentrate the applied force on a discrete portion of the mitral valve annulus.
- the force applier preferably has a cross-sectional dimension greater than the unstressed cross-sectional dimension of the coronary sinus to change the shape of the mitral valve annulus.
- the force applier also preferably has an axial length substantially less than half the circumference of the mitral valve annulus.
- the device may be an expandable structure that expands from a collapsed condition to an expanded condition defining a deployed transverse dimension greater than the unstressed diameter of the coronary sinus.
- the device may be a frame structure.
- the device may be balloon expandable, mechanically expandable, or self-expandable .
- the device may further include a force distributor that distributes the applied force along a pericardial wall of the coronary sinus.
- the force applier may be configured to apply the applied force to a plurality of discrete portions of the atrial wall of the coronary sinus.
- the surface area of the force distributor is preferably substantially greater than the surface area of the force applier.
- the present invention further provides a mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device including a force distributor and a force applier.
- the force distributor distributes an applied force along a pericardial wall of the coronary sinus and the force applier applies the applied force to at least one discrete portion of a wall of the coronary sinus adjacent to the mitral valve annulus to concentrate the applied force on at least one discrete portion of the mitral valve annulus.
- the force applier has a length substantially less than one half the mitral valve annulus circumference. The force applier may apply the applied force to a plurality of discrete portions of the wall of the coronary sinus adjacent to the mitral valve annulus.
- the force distributor may include an elongated first member configured to substantially continuously contact the pericardial wall of the coronary sinus and the force applier may include a second member extending from the first member at an angle and having an end that applies the applied force.
- the second member may be resiliently connected to the first member.
- the first and second members may be integrally formed from a same elongated member which may be formed from a resilient material. The second member extend from the first member intermediate opposed ends of the first member .
- the force applier may further include at least one additional member extending from the first member intermediate the opposed ends of the first member.
- the at least one additional member may extend from the first member substantially parallel to the second member.
- the first and second members may form an integral structure.
- the force distributor may be an elongated frame structure and the force applier may be at least one columnar frame structure extending from the elongated frame structure.
- the at least one columnar frame structure is preferably expandable from a collapsed condition to an expanded columnar condition.
- the at least one columnar frame structure may be balloon expandable or self-expandable.
- the elongated frame structure may also be expandable from a collapsed condition to an expanded condition.
- the elongated frame structure may be balloon expandable or self- expandable .
- the force applier may include a plurality of columnar frame structures.
- the plurality of columnar frame structures preferably are expandable from a collapsed condition to an expanded columnar condition.
- the plurality of columnar frame structures may be balloon expandable or self- expandable .
- the device may be an elongated frame structure.
- the elongated frame structure may have a portion of increased transverse dimension to form the force applier.
- the elongated frame structure may be expandable in transverse dimension and be balloon expandable.
- the device may be an elongated member having outwardly curved end portions that engage the pericardial wall of the coronary sinus to form the force distributor and an inwardly curved portion between the outwardly curved end portions to form the force applier.
- the invention further provides a method of treating dilated cardiomyopathy of a heart including the step of applying a force to a discrete localized portion of an atrial wall of a coronary sinus to concentrate the force on a corresponding localized portion of a mitral valve annulus to change the shape of the mitral valve annulus.
- the applying step may include the step of implanting a force applying device in the coronary sinus, the device applying the force to the discrete localized portion of the coronary sinus.
- the device is preferably expandable from a collapsed condition to a deployed condition.
- the implanting step is preferably carried out while the device is in the collapsed condition, and the device is preferably expanded to the deployed condition after the device is implanted.
- the device may be self-expandable, expanded with a balloon, or be mechanically expandable .
- the method may further include the step of distributing the applied force along a pericardial wall of the coronary sinus .
- the applying step may include the step of applying the force to a plurality of discrete localized portions of the atrial wall of the coronary sinus while the applied force is distributed along the pericardial wall of the coronary sinus.
- the applying step may include the step of implanting a force applying device in the coronary sinus, the device applying the force to the plurality of discrete localized portions of the coronary sinus.
- the device is preferably expandable from a collapsed condition to a deployed condition and the implanting step is preferably carried out while the device is in the collapsed condition.
- FIG. 1 is a superior view of a human heart with the atria removed
- FIG. 2 is a superior view of a human heart similar to FIG. 1 illustrating a deployed mitral valve device embodying the present invention
- FIG. 3 is a superior view of a human heart similar to FIG. 1 illustrating another deployed mitral valve device embodying the present invention
- FIG. 4 is another superior view of a human heart similar to FIG. 1 illustrating a still further mitral valve device embodying the present invention
- FIG. 5 is a further superior view of a human heart similar to that of FIG. 1 illustrating a still further mitral valve device embodying the present invention
- FIG. 6 is a perspective view of another mitral valve device embodying the present invention.
- FIG. 7 is another perspective view of a further mitral valve device structured in accordance with the present invention.
- FIG. 8 is another superior view of a human heart similar to FIG. 1 illustrating a still another implanted mitral valve device embodying the present invention;
- FIG. 9 is a side view of the device of FIG. 8 being expanded by a balloon into a deployed condition in accordance with the present invention;
- FIG. 10 is a perspective view of another mitral valve device shown in a collapsed condition in accordance with the present invention.
- FIG. 11 is another perspective view of the device of FIG. 9 shown in an expanded deployed condition in accordance with the present invention.
- FIG. 12 is a perspective view of still another mitral valve device embodying the present invention.
- FIG. 1 it is a superior view of a human heart 10 with the atria removed to expose the mitral valve 12, the coronary sinus 14, the coronary artery 15, and the circumflex artery 17 of the heart 10 to lend a better understanding of the present invention. Also generally shown in FIG. 1 are the pulmonary valve 22, the aortic valve 24, and the tricuspid valve 26 of the heart 10.
- the mitral valve 12 includes an anterior cusp 16, a posterior cusp 18 and an annulus 20.
- the annulus encircles the cusps 16 and 18 and maintains their spacing to provide a complete closure during a left ventricular contraction.
- the coronary sinus 14 partially encircles the mitral valve 12 adjacent to the mitral valve annulus 20.
- the coronary sinus is part of the venus system of the heart and extends along the AV groove between the left atrium and the left ventricle. This places the coronary sinus essentially within the, same plane as the mitral valve annulus making the coronary sinus available for placement of the mitral valve therapy device of the present invention therein.
- the circumflex artery 17 branches from the coronary artery 15 and supplies blood flow to critical tissue of the heart 10.
- the circumflex artery passes beneath the coronary sinus 14 at a crossover point 19.
- the devices of the present invention avoid constriction of blood flow through the circumflex artery 17 when deployed in the coronary sinus 14.
- FIG. 2 shows a mitral valve therapy device 30 embodying the present invention.
- the device 30 has an elongated base or first member 32 having an arched configuration to substantially continuously contact the pericardial wall 13 of the coronary sinus 14.
- the base 32 forms an applied force distributor that distributes a force applied to the atrial wall 21 of the coronary sinus 14 and the adjacent mitral valve annulus 20 that reshapes the mitral valve annulus for terminating mitral regurgitation.
- the device includes a second member 34 which extends from the first member 32 at an angle 36. The second member 34 extends from the base 32 intermediate the ends 38 and 40 of the base.
- the second member contacts the atrial wall 21 of the coronary sinus 14 to apply an applied force to a localized discrete portion 23 thereof and a corresponding localized discrete portion 25 of the mitral valve annulus 20.
- the force applying second member 34 may take a configuration of a loop as shown or other configuration providing an end 42 which will apply the applied force without piercing or otherwise damaging the coronary sinus 14 or mitral valve annulus.
- the device 32 is preferably formed of a resilient biocompatible material. To that end, the device 32 may be formed of, for example, Nitinol, a nickel titanium alloy, well known in the art.
- the first and second members 32 and 34 may be formed of the same material as an integral structure or may be formed of different materials.
- the distal end 38 of the base 32 terminates proximally of the crossover point 19 of the circumflex artery 17 and coronary sinus 14. Hence, the device 32 avoids adversely effecting the blood supply provided by the circumflex artery.
- FIG. 3 it illustrates another mitral valve device 50 embodying the present invention implanted in the coronary sinus 14 of the heart 10.
- the device 50 is formed from a single elongated member of material which may be any one of the materials previously referred to.
- the device 50 includes a pair of outwardly curved end portions 52 and 54 that substantially continuously engage the pericardial wall 13 of the coronary sinus 14.
- the end portions 52 and 54 thus form the force distributor of the device 50 that distributes an applied force along the pericardial wall 13 of the coronary sinus 14.
- the device 50 further includes an inwardly curved portion 56 between the outwardly curved end portions 52 and 54 to form the force applier.
- the force applier 56 applies an applied force to a localized discrete portion 23 of the atrial wall 21 of the coronary sinus 14. This in turn applies the applied force to the corresponding localized discrete portion 25 of the mitral valve annulus 20.
- the foregoing results in the reshaping of the mitral valve annulus 20 for treating dilated cardiomyopathy.
- the distal end 58 of the device 50 is proximal to the crossover point 19 of the circumflex artery 17 and the coronary sinus 14. Hence, in accordance with this embodiment, the blood supply of the circumflex artery is not effected by the device 50.
- FIG. 4 shows another mitral valve device 60 embodying the present invention implanted and deployed in the coronary sinus 14 of the heart 10.
- the device 60 takes the form of an expandable frame structure 62 which may be formed from Nitinol, for example.
- the device 60 may be first implanted in the coronary sinus 14 in a collapsed condition and then thereafter expanded to a deployed condition as illustrated.
- the device may be expanded by a balloon as known in the art, for example.
- the device 60 may be self-expanding.
- the frame structure may be formed from Nitinol or other similar titanium based elastic material known in the art and heat treated as is known in the art while the device is in its expanded deployment condition. This sets the device.
- the device may then be collapsed and advanced into the coronary sinus with a catheter. After reaching a desired location within the coronary sinus, the collapsed device may be released from the catheter. Upon being released, the device will spring or self-expand to its expanded set and deployed condition.
- the device 60 When deployed, the device 60 has a transverse cross- sectional dimension 64 greater than the unstressed cross- sectional dimension 66 of the coronary sinus 14. As a result, the device 60, when deployed, applies an applied force to a discrete portion 23 of the atrial wall 21 of the coronary sinus 14. This in turn applies the applied force to a discrete portion 25 of mitral valve annulus 20 to reshape the mitral valve annulus.
- the force applier has an axial length substantially less than one-half the circumference of the mitral valve annulus 20.
- FIG. 5 shows another mitral valve device 70 embodying the present invention implanted in the coronary sinus 14 of the heart 10.
- the device 70 is an elongated frame structure 72.
- the device 70 has a portion 74 of increased transverse dimension 76.
- the portion of increased transverse dimension 76 cause an applied force to be applied to a discrete portion 23 of the atrial wall of the coronary sinus 14. This in turn causes the applied force to be applied to a discrete portion 25 of the mitral valve annulus 20 to reshape the mitral valve annulus 20.
- the frame structure 72 is preferably expandable from a collapsed condition permitting the device 70 to be implanted to an expanded deployed condition as illustrated to apply the applied force.
- the frame structure 72 is preferably self- expanding as previously described or may be expanded by other means such as by mechanical expansion or balloon expansion.
- the frame structure is preferably formed from Nitinol or another titanium based elastic material.
- the frame structure 72 may be formed from stainless steel, for example.
- FIG. 6 is a perspective view of another mitral valve device 80 embodying the present invention.
- the device has an elongated semi-tubular base 82 having cut-out portions 84 to allow bending of the base 82. Between the cut-out portions 84 are semi-cylindrical surfaces 86 arranged to continuously contact the pericardial wall of the coronary sinus when the device 80 is implanted in the coronary sinus to distribute the applied force.
- the device 80 further includes a force applying member 88 which extends from opposed sidewalls 90 and 92 intermediate the ends of the base 82.
- the member 88 has an end 94 for engaging a discrete portion of the atrial wall of the coronary sinus to apply the applied force to a discrete portion of the mitral valve annulus to reshape the mitral valve annulus.
- the device 80 may be formed by laser cutting a Nitinol tube or from another suitable material.
- the member 88 may be set in the illustrated position by heat treating but capable of resiliently bending in line with the sidewalls 90 and 92 for implanting and thereafter self expand to return to the deployed condition shown.
- FIG. 7 is a perspective view of another mitral valve device 100 embodying the present invention which is similar to the device 80 of FIG. 6.
- the device 100 has an elongated semi-tubular base 102 having cut-out portions 104 to allow bending of the base 102. Between the cut-out portions 104 are semi-cylindrical surfaces 106 arranged to continuously contact the pericardial wall of the coronary sinus when the device 100 is implanted in the coronary sinus to distribute the applied force.
- the device 100 further includes a pair of force applying members 108 and 109 which extend substantially parallel to each other from opposed sidewalls 110 and 112 intermediate the ends of the base 102.
- the members 108 and 109 each have an end 114 and 116 for engaging the atrial wall of the coronary sinus to apply the applied force to a plurality of discrete portions of the atrial wall of the coronary sinus to in turn apply the applied force to corresponding discrete portions of the mitral valve annulus to reshape the mitral valve annulus.
- the device 100 may also be formed by laser cutting a Nitinol tube or from another suitable material.
- the members 108 and 109 may be set in the illustrated position by heat treating but capable of resiliently bending in line with the sidewalls 110 and 112 for implanting and to thereafter spring to the deployed condition as shown.
- FIG. 8 shows still another mitral valve device 120 embodying the present invention implanted in the coronary sinus 14 of the heart 10. Like the device 100 of FIG. 7, it applies an applied force to a plurality of discrete portions 23 of the atrial wall of the coronary sinus 14 to in turn apply the force to a corresponding plurality of discrete portions 25 of the mitral valve annulus 20 to reshape the mitral valve annulus 20.
- the device 120 takes the form of a frame structure 122 having an elongated base 124 that makes substantially continuous contact with the pericardial wall 13 of the coronary sinus 14.
- the base 124 is semi-tubular. Extending from the base 124 are integral columnar structures 126 and 128. The columnar structures 126 and 128 form the force applier to apply the applied force to the plurality of discrete portions of the atrial wall of the coronary sinus.
- the frame structure like the other frame structures described herein, is expandable from a collapsed condition to permit implanting of the device to an expanded condition, once implanted, as shown.
- the frame structure 122 may be expanded by balloon expansion, mechanical expansion, or self expansion.
- the base 124 When deployed as illustrated, the base 124 has a greater surface area than the columnar structures 126 and 128 to distribute the applied force along the pericardial wall 13 of the coronary sinus 14.
- FIG. 9 shows how the device 120 of FIG. 8 may be expanded with a balloon from its collapsed condition to its expanded condition.
- a balloon 130 is inserted into the device 120. Thereafter, the balloon 130 is inflated. As the balloon 130 inflates, it forces the frame structure 122 to expand to its expanded condition to form the deployed base 124 and then deployed columnar structures 126 and 128.
- FIGS. 10 and 11 show a still further device 140 embodying the present invention and which may be mechanically expanded to a deployed condition. As best seen in FIG. 10, the device 140, when in the collapsed condition, takes the form of a hollow cylinder 142 having slits 144 along its axial length.
- FIG. 12 shows a still further device 160 embodying the present invention.
- the device is expandable as it takes the form of a balloon 162.
- the balloon when inflated to a deployed condition has a hollow core 164 to permit blood flow through the coronary sinus.
- the device 160 is expanded for applying a force to a discrete portion of the coronary sinus to reshape the mitral valve annulus .
- the balloon 162 is inflated by a balloon catheter 166 which carries the balloon 162.
- the balloon when deflated, and the catheter 166 are guided into position within the coronary sinus by a guide wire 168 upon which the catheter 166 is mounted.
- the balloon When the balloon is positioned within the coronary sinus as desired, the balloon is inflated by the introduction of a fluid or gas into an inflation port 170 of the balloon catheter 166 for applying an applied force to a discrete portion of the mitral valve annulus.
- the device of FIG. 12 is particularly well suited for temporary use, for example, to measure the effectiveness of a device in various positions or of various sizes.
- the present invention provides a mitral valve device and method for reshaping the mitral valve annulus to treat dilated cardiomyopathy.
- the devices apply an applied force to one or more desirable discrete portions of the atrial wall of the coronary sinus to reshape the adjacent mitral valve annulus in a localized, as opposed to a generalized, manner. Further, all of the embodiments disclosed herein avoid the crossover point of the circumflex artery and the coronary sinus.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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AU2002353983A AU2002353983A1 (en) | 2001-11-01 | 2002-10-31 | Focused compression mitral valve device and method |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US10/003,910 | 2001-11-01 | ||
US10/003,910 US6949122B2 (en) | 2001-11-01 | 2001-11-01 | Focused compression mitral valve device and method |
Publications (3)
Publication Number | Publication Date |
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WO2003037171A2 WO2003037171A2 (en) | 2003-05-08 |
WO2003037171A3 WO2003037171A3 (en) | 2003-11-20 |
WO2003037171A9 true WO2003037171A9 (en) | 2003-12-31 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US2002/035196 WO2003037171A2 (en) | 2001-11-01 | 2002-10-31 | Focused compression mitral valve device and method |
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US (2) | US6949122B2 (en) |
AU (1) | AU2002353983A1 (en) |
WO (1) | WO2003037171A2 (en) |
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US9510829B2 (en) | 1999-04-09 | 2016-12-06 | Evalve, Inc. | Fixation devices, systems and methods for engaging tissue |
Also Published As
Publication number | Publication date |
---|---|
US7608102B2 (en) | 2009-10-27 |
US20040249452A1 (en) | 2004-12-09 |
US6949122B2 (en) | 2005-09-27 |
WO2003037171A3 (en) | 2003-11-20 |
WO2003037171A2 (en) | 2003-05-08 |
AU2002353983A1 (en) | 2003-05-12 |
US20030083538A1 (en) | 2003-05-01 |
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