PERCUTANEOUS TRANSCATHETER REPAIR OF HEART VALVES

• US 20120123531A1
• Filed: 08/04/2011
• Published: 05/17/2012
• Est. Priority Date: 08/04/2010
• Status: Active Grant

• Current Assignee: ValCare Medical, Inc.
• Original Assignee: MiCardia Corporation
• Inventors: Tsukashima, Ross, Shaolian, Samuel M., Buchbinder, Maurice, Gray, Brian C., Packham, Victor S., Cao, Hung H.
• Granted Patent: US 8,518,107 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers

Abstract

Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer hollow member including a plurality of segments. Adjacent segments cooperate with one another to change the outer hollow member from an elongate insertion geometry to an annular operable geometry. The annuloplasty ring also includes an internal anchor member located at least partially within the outer hollow member. The internal anchor member includes a plurality of anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus. The internal anchor member is configured to move the plurality of anchors with respect to a plurality of windows in the outer hollow member to selectively deploy the plurality of anchors through the respective windows.

Claims

1. An annuloplasty ring for transcatheter heart valve repair, the annuloplasty ring comprising:

an outer hollow member comprising a plurality of segments, wherein adjacent segments cooperate with one another to change the outer hollow member from an elongate insertion geometry to an annular operable geometry; and

an internal anchor member located at least partially within the outer hollow member, the internal anchor member comprising a plurality of anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus, the internal anchor member configured to move the plurality of anchors with respect to a plurality of windows in the outer hollow member to selectively deploy the plurality of anchors through the respective windows.

2. The annuloplasty ring of claim 1, wherein the plurality of hollow segments allow the outer hollow member to be flexible in a first plane so as to be transitionable between the elongate insertion geometry and the annular operable geometry, and wherein the plurality of hollow segments in the annular insertion geometry are at least semi-rigid in a second plane that is perpendicular to the first plane.

3. The annuloplasty ring of claim 1, wherein the outer hollow member comprises a first end and a second end, and wherein the first end is configured to couple to the second end in the annular operable geometry.

4. The annuloplasty ring of claim 3, further comprising:

a female snap-lock connector attached to the first end of the outer hollow member; and

a male snap-lock connector attached to the second end of the outer hollow member.

5. The annuloplasty ring of claim 4, further comprising a suture or wire including a distal end configured to draw the male snap lock connector into the female snap lock connector by applying tension to a proximal end of the suture or wire.

6. The annuloplasty ring of claim 1, further comprising a pivot configured to removably couple the annuloplasty ring to a catheter, the pivot further configured to automatically rotate a plane of the annuloplasty ring upon exiting a catheter within a heart chamber.

7. The annuloplasty ring of claim 1, wherein the outer hollow member comprises a superelastic shape memory material configured to automatically transition from the elongate insertion geometry to the annular operable geometry upon exiting a catheter within a heart chamber.

8. The annuloplasty ring of claim 7, wherein the outer hollow member comprises a shape memory tube cut in a pattern to form the plurality of segments in a continuous series of connected segments.

9. The annuloplasty ring of claim 8, wherein

in the elongate insertion geometry, the cut shape memory tube include gaps partially separating adjacent connected segments, and wherein

in the annular operable geometry, one or more of the gaps close.

10. The annuloplasty ring of claim 1, wherein the internal anchor member comprises a superelastic shape memory material configured to automatically transition at least a portion of the internal anchor member from the elongate insertion geometry to the annular operable geometry upon exiting a catheter within a heart chamber.

11. The annuloplasty ring of claim 10, wherein the internal anchor member comprises a first shape memory ribbon having the plurality of anchors cut therein, wherein the plurality of anchors are configured to automatically transition to a curved shape upon exiting the respective windows in the outer hollow member, and wherein the transition to the curved shape self-propels the plurality of anchors into the tissue of the heart valve annulus.

12. The annuloplasty ring of claim 11, further comprising a second shape memory ribbon within the outer hollow member, the second shape memory ribbon configured to reduce friction between the first shape memory ribbon and the outer hollow member to assist in deploying the anchors.

13. The annuloplasty ring of claim 12, wherein the second shape memory ribbon is superelastic and is configured to automatically transition from the elongate insertion geometry to the annular operable geometry upon exiting the catheter within the heart chamber.

14. The annuloplasty ring of claim 12, wherein the second shape memory ribbon comprises a selectively adjustable member configured to be activated postoperatively by application of external energy to change the shape of the annuloplasty ring.

15. The annuloplasty ring of claim 10, wherein the internal anchor member comprises a shape memory tube cut to form a plurality of prongs between tubular portions of the tube, wherein the prongs are transition to linear configurations of respective anchors upon exiting the respective windows in the outer hollow member.

16. The annuloplasty ring of claim 15, further comprising a selectively adjustable member passing through the tubular portions of the shape memory tube, the selectively adjustable member configured to be activated postoperatively by application of external energy to change the shape of the annuloplasty ring.

17. The annuloplasty ring of claim 15, further comprising one or more barbs attached to each of the plurality of prongs.

18. The annuloplasty ring of claim 1, further comprising a suture or wire including a distal end removably coupled to the internal anchor member, the suture or wire configured to slide the internal anchor member within the outer hollow member, by applying tension to a proximal end of the suture or wire, so as to deploy the plurality of anchors from the respective windows.

19. The annuloplasty ring of claim 1, wherein the annular operable geometry comprises a D-shape corresponding to an anatomical geometry of a human mitral valve annulus, wherein the annuloplasty ring in the annular operable geometry comprises a first dimension corresponding to an anterior-posterior dimension of the mitral valve annulus and a second dimension corresponding to a commissure-commissure dimension of the mitral valve annulus, and wherein a ratio of a distance of the first dimension to a distance of the second dimension is in a range between about 0.60 and about 0.70.

20. A method for percutaneous transcatheter repair of a mitral valve in a heart, the method comprising:

percutaneously introducing a distal end of a first catheter into a left atrium of the heart;

inserting a segmented annuloplasty ring, attached to a second catheter, through the first catheter into the left atrium, the ring including a superelastic shape memory material that transforms the ring from an elongate insertion geometry to an annular operable geometry as the ring exits the distal end of the first catheter;

automatically rotating the ring to change a plane of the ring from a first direction that is parallel to the second catheter to a second direction that is parallel to a plane of a mitral valve annulus;

pulling a first suture, connected to the ring through the second catheter, to couple the ends of the ring together;

pulling a second suture, connected to the ring through the second catheter, to deploy a plurality of tissue anchors from the ring; and

inserting an expansion device through the first catheter into the left atrium and activating the expansion device to press the ring against the mitral valve annulus so as to drive the anchors into the surrounding tissue.

21. The method of claim 20, further comprising:

detaching the ring from the second catheter and the first and second sutures; and

removing the first and second catheters from the heart.

22. The method of claim 20, wherein percutaneously introducing the distal end of the first catheter into the left atrium of the heart comprises a trans-septal approach through the inferior vena cava, right atrium, and interatrial septum into the left atrium.

23. The method of claim 20, wherein percutaneously introducing the distal end of the first catheter into the left atrium of the heart comprises a retrograde approach through the aorta, aortic valve, left ventricle, and mitral valve into the left atrium.

24. The method of claim 20, wherein percutaneously introducing the distal end of the first catheter into the left atrium of the heart comprises a trans-apical approach through the apex of the heart, left ventricle, and mitral valve into the left atrium.

25. A method for percutaneous transcatheter repair of a mitral valve in a heart, the method comprising:

percutaneously introducing a distal end of a first catheter into a left atrium of the heart;

inserting a segmented annuloplasty ring, attached to a second catheter, through the first catheter into the left atrium, the ring including a superelastic shape memory material that transforms the ring from an elongate insertion geometry to an annular operable geometry as the ring exits the distal end of the first catheter;

automatically rotating the ring to change a plane of the ring from a first direction that is parallel to the second catheter to a second direction that is parallel to a plane of a mitral valve annulus;

inserting an expansion device through the first catheter into the left atrium and activating the expansion device to press the ring against the mitral valve annulus;

pulling a first suture, connected to the ring through the second catheter, to deploy a plurality of tissue anchors from the ring as it is pressed against the mitral valve annulus, wherein each of the plurality of anchors includes a superelastic shape memory material that self-propels the superelastic anchors into the tissue of the mitral valve annulus; and

pulling a second suture, connected to the ring through the second catheter, to couple the ends of the ring together and cinch the mitral valve annulus to a desired size.

26. The method of claim 25, further comprising:

detaching the ring from the second catheter and the first and second sutures; and

removing the first and second catheters from the heart.

27. The method of claim 26, wherein percutaneously introducing the distal end of the first catheter into the left atrium of the heart comprises a trans-septal approach through the inferior vena cava, right atrium, and interatrial septum into the left atrium.

28. The method of claim 26, wherein percutaneously introducing the distal end of the first catheter into the left atrium of the heart comprises a retrograde approach through the aorta, aortic valve, left ventricle, and mitral valve into the left atrium.

29. The method of claim 26, wherein percutaneously introducing the distal end of the first catheter into the left atrium of the heart comprises a trans-apical approach through the apex of the heart, left ventricle, and mitral valve into the left atrium.

30. A delivery system for percutaneous transcatheter delivery of an annuloplasty ring to repair a heart valve of a body of a patient, the delivery apparatus comprising:

an outer jacket delivery catheter;

a catheter shaft sized and configured to pass through the outer jacket delivery catheter;

a ring shuttle attached to a distal end of the catheter shaft, the ring shuttle configured to be removably coupled to a segmented annuloplasty ring;

a first deployment lumen sized and configured to pass through the outer jacket delivery catheter, the first deployment lumen configured to provide a pathway for a first suture for coupling together first and second ends of the ring;

a second deployment lumen sized and configured to pass through the outer jacket delivery catheter, the second deployment lumen configured to provide a pathway for a second suture for deploying anchors from the ring; and

a third deployment lumen sized and configured to pass through the outer jacket delivery catheter, the third deployment lumen configured to provide a pathway for a ring deployment wire for automatically orienting the ring within the heart and selectively releasing the ring from the ring shuttle.

31. The delivery system of claim 30, further comprising:

a hemostatic connector coupled to a proximal end of the outer jacket delivery catheter;

a first torque controller coupled to the hemostatic connector for selectively controlling the first suture for coupling together first and second ends of the ring;

a second torque controller coupled to the hemostatic connector for selectively controlling the second suture for deploying the anchors from the ring; and

a third torque controller coupled to the hemostatic connector for selectively controlling the ring deployment wire for releasing the ring from the ring shuttle.

32. The delivery system of claim 30, wherein the ring deployment wire comprises a superelastic shape memory material biased as the ring shuttle passes through the outer jacket delivery catheter for automatically orienting the ring within the heart upon pushing the ring from the outer jacket delivery catheter.