Delivery devices and methods for heart valve repair

• US 20060058817A1
• Filed: 07/27/2004
• Published: 03/16/2006
• Est. Priority Date: 06/13/2002
• Status: Active Grant

• Current Assignee: Guided Delivery Systems, Inc.
• Original Assignee: Guided Delivery Systems, Inc.
• Inventors: Starksen, Niel F., To, John, Morales, Rodolfo A., Fabro, Mariel, Wei, Michael F.
• Granted Patent: US 7,666,193 B2
• Time in Patent Office: Days
• US Class Current: 606/142
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres

Abstract

Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting the anchor delivery device with a length of the valve annulus, delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus, and drawing the anchors together to circumferentially tighten the valve annulus. Devices generally include an elongate catheter having at least one tensioning member and at least one tensioning actuator for deforming a distal portion of the catheter to help it conform to a valve annulus. The catheter device may be used to navigate a subannular space below a mitral valve to facilitate positioning of an anchor delivery device.

Claims

1. A device for performing a procedure on heart valve annulus, the device comprising:

a flexible, elongate catheter having a proximal portion and a shaped distal portion, the distal portion having at least one aperture for allowing passage of tissue anchors;

multiple tissue anchors releasably housed in the shaped distal portion;

at least one cinchable tether slidably coupled with the tissue anchors; and

at least one anchor delivery member housed in the distal portion for delivering the anchors out of the at least one aperture to engage tissue of the valve annulus.

2. A device as in claim 1, wherein the shaped distal portion comprises at least a first curve.

3. A device as in claim 2, wherein the first curve has a radius of curvature between 0.5 inches and 1.5 inches.

4. A device as in claim 2, wherein the shaped distal portion further comprises a second curve.

5. A device as in claim 4, wherein the first and second curves orient a distal-most portion of the catheter at an angle of between 45°

and 90°

, relative to the proximal portion of the catheter immediately adjacent the distal portion.

6. A device as in claim 4, wherein the second curve has a radius of curvature approximating a radius of curvature of the heart valve.

7. A device as in claim 4, wherein the second curve has a radius of curvature greater than a radius of curvature of the heart valve, wherein the greater radius of curvature causes the distal portion to press outward against the valve annulus.

8. A device as in claim 4, wherein at least one of the first and second curves has the same shape as a corresponding curve in a guide catheter used for delivering the elongate catheter into contact with the valve annulus.

9. A device as in claim 8, wherein at the first and second curves in the elongate catheter correspond to first and second corresponding curves in the guide catheter.

10. A device as in claim 8 or 9, wherein the elongate catheter, when advanced through the guide catheter, is oriented such that the at least one aperture contacts the valve annulus tissue.

11. A device as in claim 1, further comprising at least one stabilizing member coupled with the elongate catheter for maintaining the distal portion in contact with valve annulus tissue.

12. A device as in claim 11, wherein the at least one stabilizing member comprises a spiral-shaped member extending from the distal portion to press against heart wall tissue, thus urging the distal portion against the annulus tissue.

13. A device as in claim 12, wherein a distal end of the spiral-shaped member is adapted to engage and press against a junction of one or more papillary muscles and heart wall tissue.

14. A device as in claim 11, wherein the at least one stabilizing member comprises an arch-shaped shape-memory or spring-loaded member extending from the distal portion to press against heart wall tissue, thus urging the distal portion against the annulus tissue.

15. A device as in claim 14, wherein a portion of the arch-shaped member is adapted to engage and press against a junction of one or more papillary muscles and heart wall tissue.

16. A device as in claim 14, further comprising an expandable member coupled with the arch-shaped member for inflating to further press against the heart wall tissue.

17. A device as in claim 11, wherein the at least one stabilizing member comprises multiple springs extending from the distal portion to press against heart wall tissue, thus urging the distal portion against the annulus tissue.

18. A device as in claim 11, wherein the at least one stabilizing member comprises a curved balloon coupled with the distal portion of the catheter, the curved balloon having a greater radius of curvature than a radius of curvature of the valve annulus, wherein inflating the balloon urges the distal portion against the annulus tissue.

19. A device as in claim 1, further comprising at least one termination member for enhancing attachment of a terminal tissue anchor to the heart valve annulus.

20. A device as in claim 19, wherein the at least one termination member is slidably couplable with the tether.

21. A device as in claim 20, wherein the at least one termination member is coupled with the tether via a termination catheter device.

22. A device as in claim 20, wherein the at least one termination member comprises at least one deployable tissue attachment member deployable from a retracted configuration for delivery to an expanded configuration for attachment to the valve annulus tissue.

23. A device as in claim 22, wherein the at least one tissue attachment member comprises a plurality of members selected from the group consisting of barbs, points, needles, hooks, tines, rakes, wires and teeth.

24. A device as in claim 23, wherein the plurality of members comprise a shape-memory or super-elastic material.

25. A device as in claim 23, wherein the plurality of members are disposed circumferentially about a cylindrical member adapted to slide over the tether.

26. A device as in claim 23, wherein the plurality of members are disposed along a portion of a cylindrical member adapted to slide over the tether.

27. A device as in claim 22, wherein the at least one tissue attachment member further includes a pusher for pushing the tissue attachment member out of the elongate catheter and into the valve annulus tissue.

28. A device as in claim 22, wherein the at least one tissue attachment member is adapted to engage the terminal tissue anchor.

29. A device as in claim 22, wherein the at least one tissue attachment member is adapted to enter into the valve annulus tissue in a direction from the terminal tissue anchor toward the other tissue anchors.

30. A device as in claim 22, wherein the at least one tissue attachment member further comprises a fiber, matrix, textile or mesh disposed on at least a portion of the tissue attachment member for enhancing tissue in-growth over the tissue attachment member.

31. A device as in claim 1, wherein each of the tissue anchors comprises at least one tissue engagement feature for preventing the anchors from being pulled out of the valve annulus tissue when the tether is cinched.

32. A device as in claim 31, wherein the at least one tissue engagement feature comprises a barb on each end of each tissue anchor.

33. A device as in claim 32, wherein the barb faces inward toward a center of the anchor.

34. A device as in claim 32, wherein the barb faces outward away from a center of the anchor.

35. A device as in claim 31, wherein the at least one tissue engagement feature comprises a plurality of bends in each anchor.

36. A device as in claim 1, wherein each of the tissue anchors comprises at least one support member for preventing the anchors from being pulled out of the valve annulus tissue when the tether is cinched.

37. A device as in claim 36, wherein the support member comprises an attachment point of one arm of each anchor to another arm of each anchor, the attachment point positioned adjacent an eyelet of the anchor.

38. A device as in claim 37, further comprising a constraining member disposed over the attachment point.

39. A device as in claim 38, wherein the constraining member is selected from the group consisting of a band, tie, sleeve and belt.

40. A device as in claim 1, wherein each of the tissue anchors comprises at least one tissue adhesion feature adapted to enhance attachment of the tissue anchors to the valve annulus tissue.

41. A device as in claim 40, wherein the tissue adhesion feature comprises one or more materials disposed over at least part of each anchor, the material(s) selected to promote encapsulation of the anchors within the valve annulus tissue.

42. A device as in claim 1, wherein the at least one anchor delivery member comprises:

an anchor contacting member for contacting and urging the anchors out of the at least one aperture; and

a pull cord coupled with the anchor contacting member for applying force to the anchor contacting member to contact and urge the anchors.

43. A device for constricting a valve annulus in a heart, the device comprising:

a plurality of slidably coupled tissue anchors, each anchor including at least one tissue attachment feature for enhancing attachment of the anchor to valve annulus tissue; and

at least one cinchable tether slidably coupled with at least some of the tissue anchors and fixedly attached to at least a first of the anchors.

44. A device as in claim 43, wherein the at least one attachment feature comprises a porous surface along at least a portion of each anchor.

45. A device as in claim 43, wherein the at least one attachment feature comprises a textured surface along at least a portion of each anchor.

46. A device as in claim 43, wherein the at least one attachment feature comprises a coated surface along at least a portion of each anchor.

47. A device as in claim 43, wherein the at least one attachment feature comprises at least one circular or hooked portion of each anchor having a small radius of curvature.

48. A device as in claim 43, wherein the at least one attachment feature comprises a barb at each end of each anchor.

49. A method of constricting a valve annulus in a heart, the method comprising:

contacting a shaped distal portion of an anchor delivery catheter device with a length of the valve annulus;

delivering a plurality of slidably coupled anchors from the anchor delivery device to secure the anchors to the annulus;

drawing the anchors together to circumferentially tighten the valve annulus; and

promoting attachment of the anchors to valve annulus tissue to help secure the anchors to the tissue over time.

50. A method as in claim 49, wherein contacting the distal portion comprises advancing the catheter device through a shaped introducer device, a shape of the shaped distal portion corresponding to a shape of the introducer device.

51. A method as in claim 50, wherein advancing the catheter device through the introducer devices orients one or more apertures on the catheter device with the valve annulus tissue, so that the anchors are delivered into the tissue.

52. A method as in claim 49, further comprising stabilizing the distal portion of the catheter device against the valve annulus tissue.

53. A method as in claim 52, wherein stabilizing comprises deploying at least one stabilizing member from the distal portion of the catheter device to contact heart wall tissue of the heart.

54. A method as in claim 49, further comprising securing at least one termination member to the valve annulus tissue, to help maintain attachment of the coupled anchors to the tissue.

55. A method as in claim 54, wherein securing the termination member comprises:

sliding the termination member along a tether slidably coupled with the anchors; and

deploying tissue engagement means on the termination member from an unexpanded to an expanded configuration to engage the valve tissue.

56. A method as in claim 55, further comprising engaging the tissue engagement means with at least a terminal anchor of the plurality of anchors.

57. A method as in claim 49, wherein promoting attachment of the anchors to the tissue comprises contacting at least one surface feature of each anchor with the tissue.

58. A method as in claim 57, wherein contacting the surface feature comprises contacting at least one of a porous surface, a roughened surface, a coated surface and an abrasive surface with the tissue.

59. A method for contacting a shaped distal portion of an anchor delivery catheter with a mitral valve annulus of a heart, the method comprising advancing the anchor delivery catheter through a shaped guide catheter into the left ventricle to contact the mitral valve, wherein at least one bend in the shaped distal portion of the delivery device has approximately the same radius of curvature at least one corresponding bend in the guide catheter, and wherein advancing the distal portion of the delivery catheter through the at least one corresponding bend positions one or more anchor delivery apertures of the anchor delivery catheter in contact with the mitral valve annulus.