Coaptation enhancement implant, system, and method

• US 8,845,717 B2
• Filed: 05/03/2011
• Issued: 09/30/2014
• Est. Priority Date: 01/28/2011
• Status: Active Grant

• Current Assignee: Polares Medical Inc. (Polares Medical SA)
• Original Assignee: Middle Park Medical Incorporated
• Inventors: Khairkhahan, Alex, Lesh, Michael D.
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/099,532
• Publication Number:
  US 20120197388A1
• Time in Patent Office: 1,246 Days
• Field of Search: 606/151, 623/2.11, 623/2.3, 623/2.38, 600/37, 128/831, 128/898
• US Class Current: 623/2.11
• 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 17/068 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 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle. An outer surface of the valve body may accommodate tissue ingrowth or endothelialization, while a fluid-absorbing matrix can swell after introduction into the heart. The valve body shape may be selected after an anchor has been deployed, and catheter-based deployment systems may have a desirable low profile.

Claims

1. A coaptation assist implant for treating mal-coaptation of a heart valve of a heart in a patient, the heart valve having an annulus, first and second leaflets, and first and second commissures, the annulus defining a valve axis extending along a blood flow path, the first and second leaflets having a coaptation zone defining a curve extending across the blood flow path, the implant comprising:

a coaptation assist body having an axis and first and second opposed major coaptation surfaces, each opposed major coaptation surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body introducible into the heart and supportable within the heart so that the axis of the coaptation assist body extends along the axis of the valve with the first and second lateral edges of the coaptation assist body extending along the curve of the coaptation zone of the heart valve;

the coaptation assist body deployable from a first configuration to a second configuration by removing the coaptation assist body from within a surrounding deployment catheter,

wherein the coaptation assist body has an insertion volume within the deployment catheter and a deployed volume greater than the insertion volume, and wherein the coaptation assist body is volumetrically expandable within the heart so as to increase a thickness of the coaptation assist body between the first and second opposed major coaptation surfaces,

wherein the coaptation assist body comprises a permeable material, and wherein the coaptation assist body is configured to volumetrically expand when released in the heart without the coaptation assist body being inflated using inflation fluid introduced from outside a vascular system of the patient.

2. The implant of claim 1, wherein coaptation assist body is deployable by laterally unrolling, unforcing, and/or unfolding the coaptation assist body within the heart.

3. The implant of claim 1, wherein the coaptation assist body comprises a tissue-ingrowth material layer disposed over a core material, the core material expanding when released inside the heart.

4. The implant of claim 1, wherein the coaptation assist body comprises a layer of ePTFE over a foam or other liquid absorbing matrix.

5. A coaptation assist system for treating mal-coaptation of a heart valve of a heart in a patient, the heart valve having an annulus, first and second leaflets, and first and second commissures, the annulus defining a valve axis extending along a blood flow path, the system comprising:

a catheter system including a catheter body having a proximal end and a distal end, the distal end being steerable within the heart from the proximal end;

a first anchor selectively deployable from within the heart with the catheter system at a first target location of the heart near the first commissure; and

a coaptation assist body having an axis and first and second opposed major coaptation surfaces, each opposed major coaptation surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body introducible into the heart and coupleable in vivo with the first anchor after the first anchor is deployed in the heart so that the first lateral edge extends toward the first commissure;

a second anchor selectively deployable from within the heart with the catheter system at a second target location of the heart near the second commissure, the second lateral edge of the coaptation assist body coupleable in vivo with the second anchor after the second anchor is deployed in the heart so that the coaptation assist body is supported by the second anchor with the second lateral edge extending toward the second commissure; and

a first crimp that recieves a portion of the anchor and a second crimp that recieves a portion of the second anchor, the first crimp and the second crimp operably connected to an atrial support extending laterally from the coaptation assist body.

6. The system of claim 5, further comprising a plurality of alternatively selectable coaptation assist bodies having differing geometries, each of the coaptation assist bodies coupleable with the first anchor after the first anchor is deployed in the heart so that the coaptation assist body is supported by the first anchor with the first lateral edge extending toward the first commissure to mitigate differing mal-coaptation characteristics.

7. The system of claim 6, wherein, for at least some of the coaptation assist bodies, flanges of the deployed coaptation assist bodies protrude laterally from the opposed major coaptation surface so as to inhibit leaflet prolapse, and wherein geometries of the flanges differ among the coaptation assist bodies so as to mitigate differing leaflet prolapse characteristics of different patients.

8. The system of claim 6, wherein, for at least some of the coaptation assist bodies, a thickness of the deployed coaptation assist body between the first opposed major coaptation surface and the second opposed major coaptation surface varies along a curve, and wherein localized enhancements in the thickness are at different locations along the curves of the coaptation assist bodies so as to mitigate differing localized mal-coaptation characteristics of different patients.

9. The system of claim 5, wherein the coaptation assist body further comprises axial struts which inhibit axial bending.

10. The system of claim 5, wherein the coaptation assist body further comprises a ventricular anchor.

11. The system of claim 10, wherein a coupler is located between the coaptation assist body and the ventricular anchor.

12. The system of claim 10, wherein the ventricular anchor extends through a hub, the hub operably connected along the axis of the coaptation assist body.

13. The system of claim 5, wherein the coaptation assist body further comprises a fluid absorbing core.

14. The system of claim 13, wherein the fluid absorbing core has a small volume configuration prior to implantation.

15. The system of claim 5, further comprising a structural mounting to facilitate in situ assembly of the coaptation assist body and the first anchor.

16. A coaptation assist implant for treating mal-coaptation of a heart valve of a heart in a patient, the heart valve having an annulus, first and second leaflets, and first and second commissures, the annulus defining a valve axis extending along a blood flow path, the first and second leaflets having a coaptation zone with a mal-coaptation geometry, the implant comprising:

a coaptation assist body having an axis and first and second opposed major coaptation surfaces, each opposed major coaptation surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body supportable within the heart so that the axis of the implant extends along the axis of the valve with the first and second lateral edges of the coaptation assist body extend along the coaptation zone;

a first anchor selectively deployable from within the heart with a catheter system at a first target location of the heart near the first commissure, and a second anchor selectively deployable from within the heart with the catheter system at a second target location of the heart near the second commissure; and

a first crimp that receives a portion of the first anchor and a second crimp that recieves a portion of the second anchor, the first crimp and the second crimp operably connected to an atrial support extending laterally from the coaptation assist body,

wherein the coaptation assist body of the implant is sufficiently conformable that engagement between the implant and the leaflets of the heart significantly conforms a shape of the coaptation assist body between the leaflets toward the mal-coaptation geometry of the leaflets.

17. The system of claim 16, wherein the atrial support is disposed between the first anchor and the second anchor.

18. The system of claim 16, wherein the coaptation assist body further comprises axial struts which inhibit axial bending.

19. The system of claim 16, wherein the coaptation assist body further comprises a ventricular anchor.

20. The system of claim 19, wherein a coupler is located between the coaptation assist body and the ventricular anchor.

21. The system of claim 19, wherein the ventricular anchor extends through a hub, the hub operably connected along the axis of the coaptation assist body.

22. The system of claim 16, wherein the coaptation assist body further comprises a fluid absorbing core.

23. The system of claim 22, wherein the fluid absorbing core has a small volume configuration prior to implantation.

24. The system of claim 16, further comprising structural mountings to facilitate in situ assembly of the coaptation assist body and the first anchor.

25. A coaptation assist device for treating mal-coaptation of a heart valve of a heart in a patient, the heart valve having an annulus, first and second leaflets, and first and second commissures, the annulus defining a valve axis, the first and second leaflets having a coaptation zone, the device comprising:

a coaptation assist body having an axis and first and second opposed major coaptation surfaces, wherein the coaptation assist body defines a channel within the coaptation assist body, the coaptation assist body introducible into the heart and coupleable in vivo within the heart valve;

a tether disposed within the channel and coupled to the coaptation assist body near a first end of the channel; and

a curvature lock attached to the tether near a second end of the channel, the tether being lockable by the curvature lock to constrain the distance between the first and second ends of the channel so as to define a curvature of the coaptation assist body.

26. The coaptation assist device of claim 25, further comprising:

a central atrial anchor affixed to an upstream end of the coaptation assist body and deployable to fix the upstream end of the coaptation assist body to the heart.

27. The coaptation assist device of claim 25, further comprising a ventricular anchor affixed to a downstream end of the coaptation assist body and deployable to fix the downstream end of the coaptation assist body to ventricular a tissue of the heart.

28. The coaptation assist device of claim 25, further comprising a first lateral anchor affixed proximate a first lateral edge of an upstream end of the coaptation assist body and a second lateral anchor affixed proximate a second lateral edge of the upstream end of the coaptation assist body, the first lateral anchor and the second lateral anchor deployable to fix the upstream end to the heart proximate the first and second commissures of the heart valve.

29. The coaptation assist device of claim 25, wherein the tether comprises a wire or a suture, and wherein the curvature lock comprises a crimp on the wire or suture.

30. A coaptation assist system for treating mal-coaptation of a heart valve of a heart in a patient, the heart valve having an annulus, first and second leaflets, and first and second commissures, the annulus defining a valve axis, the system comprising:

a catheter system including a catheter body having a proximal end and a distal end, the distal end being steerable within the heart from the proximal end;

a coaptation assist body having an axis and first and second opposed major coaptation surfaces, each opposed major coaptation surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body introducible into the heart and coupleable in vivo within the heart valve, wherein the coaptation assist body defines a channel;

a tether extending through the channel such that a curvature of the coaptation assist body is adjustable by varying the distance between the ends of the channel along the tether; and

a curvature lock on the tether operable to constrain the distance between the ends of the channel so as to define a curvature of the coaptation assist body.

31. The system of claim 30, further comprising a central anchor deployable to anchor an upstream end of the coaptation assist body to the annulus of the heart valve.

32. The system of claim 31, further comprising a first lateral anchor affixed proximate the first lateral edge of the upstream end of the coaptation assist body and a second lateral anchor affixed proximate the second lateral edge of the upstream end of the coaptation assist body, the first lateral anchor and the second lateral anchor deployable to fix the upstream end to the heart proximate the first and second commissures of the heart valve.

33. The system of claim 31, further comprising a ventricular anchor affixed proximate a downstream end of the coaptation assist body and deployable to fix the downstream end to ventricular tissue of the heart.

34. The system of claim 31, wherein the tether comprises a wire or a suture, and wherein the curvature lock comprises a crimp on the wire or suture.

35. A coaptation assist system for treating mal-coaptation of a heart valve of a heart in a patient, the heart valve having an annulus, first and second leaflets, and first and second commissures, the annulus defining a valve axis extending along a blood flow path, the system comprising:

a catheter system including a catheter body having a proximal end and a distal end, the distal end being steerable within the heart from the proximal end;

a first anchor selectively deployable from within the heart with the catheter system at a first target location of the heart near the first commissure; and

a coaptation assist body having an axis and first and second opposed major coaptation surfaces, each opposed major coaptation surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body introducible into the heart and coupleable in vivo with the first anchor after the first anchor is deployed in the heart so that the first lateral edge extends toward the first commissure,

wherein the coaptation assist body further comprises a ventricular anchor, the ventricular anchor extending through a hub, the hub operably connected along the axis of the coaptation assist body.

36. The system of claim 35, further comprising a plurality of alternatively selectable coaptation assist bodies having differing geometries, each of the coaptation assist bodies coupleable with the first anchor after the first anchor is deployed in the heart so that the coaptation assist body is supported by the first anchor with the first lateral edge extending toward the first commissure to mitigate differing mal-coaptation characteristics.

37. The system of claim 36, wherein, for at least some of the coaptation assist bodies, a thickness of the deployed coaptation assist body between the first opposed major coaptation surface and the second opposed major coaptation surface varies along a curve, and wherein localized enhancements in the thickness are at different locations along the curves of the coaptation assist bodies so as to mitigate differing localized mal-coaptation characteristics of different patients.

38. The system of claim 36, wherein, for at least some of the coaptation assist bodies, flanges of the deployed coaptation assist bodies protrude laterally from the opposed major coaptation surface so as to inhibit leaflet prolapse, and wherein geometries of the flanges differ among the coaptation assist bodies so as to mitigate differing leaflet prolapse characteristics of different patients.

39. The system of claim 35, further comprising a second anchor selectively deployable from within the heart with the catheter system at a second target location of the heart near the second commissure, the second lateral edge of the coaptation assist body coupleable in vivo with the second anchor after the second anchor is deployed in the heart so that the coaptation assist body is supported by the second anchor with the second lateral edge extending toward the second commissure.

40. The system of claim 39, wherein the coaptation assist body further comprises a lateral atrial support disposed between the first anchor and the second anchor.

41. The system of claim 39, further comprising a first crimp that receives a portion of the first anchor and a second crimp that receives a portion of the second anchor, the first crimp and the second crimp operably connected to an atrial support extending laterally from the coaptation assist body.

42. The system of claim 35, wherein the coaptation assist body further comprises axial struts which inhibit axial bending.

43. The system of claim 35, wherein a coupler is located between the coaptation assist body and the ventricular anchor.

44. The system of claim 35, wherein the coaptation assist body further comprises a fluid absorbing core.

45. The system of claim 44, wherein the fluid absorbing core has a small volume configuration prior to implantation.

46. The system of claim 35, further comprising a structural mounting to facilitate in situ assembly of the coaptation assist body and the first anchor.

47. The system of claim 35, further comprising a first crimp that receives a portion of the first anchor, the first crimp operably connected to an atrial support extending laterally from the coaptation assist body.

48. A coaptation assist system for treating mal-coaptation of a heart valve in a patient, the heart valve of a heart having an annulus, first and second leaflets, and first and second commissures the annulus defining a valve axis extending along a blood flow path, the system comprising:

a catheter system including a catheter body having a proximal end and a distal end, the distal end being steerable within the heart from the proximal end;

a first anchor selectively deployable from within the heart with the catheter system at a first target location of the heart near the first commissure; and

a coaptation assist body having an axis and first and second opposed major coaptation surfaces, each opposed major coaptation surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body introducible into the heart and coupleable in vivo with the first anchor after the first anchor is deployed in the heart so that the first lateral edge extends toward the first commissure; and

a first crimp that receives a portion of the first anchor, the first crimp operably connected to an atrial support extending laterally from the coaptation assist body.

49. The system of claim 48, further comprising a plurality of alternatively selectable coaptation assist bodies having differing geometries, each of the coaptation assist bodies coupleable with the first anchor after the first anchor is deployed in the heart so that the coaptation assist body is supported by the first anchor with the first lateral edge extending toward the first commissure to mitigate differing mal-coaptation characteristics.

50. The system of claim 49, wherein, for at least some of the coaptation assist bodies, a thickness of the deployed coaptation assist body between the first opposed major coaptation surface and the second opposed major coaptation surface varies along a curve, and wherein localized enhancements in the thickness are at different locations along the curves of the coaptation assist bodies so as to mitigate differing localized mal-coaptation characteristics of different patients.

51. The system of claim 49, wherein, for at least some of the coaptation assist bodies, flanges of the deployed coaptation assist bodies protrude laterally from the opposed major coaptation surface so as to inhibit leaflet prolapse, and wherein geometries of the flanges differ among the coaptation assist bodies so as to mitigate differing leaflet prolapse characteristics of different patients.

52. The system of claim 48, further comprising a second anchor selectively deployable from within the heart with the catheter system at a second target location of the heart near the second commissure, the second lateral edge of the coaptation assist body coupleable in vivo with the second anchor after the second anchor is deployed in the heart so that the coaptation assist body is supported by the second anchor with the second lateral edge extending toward the second commissure.

53. The system of claim 52, further comprising a second crimp that receives a portion of the second anchor, the second crimp operably connected to the atrial support extending laterally from the coaptation assist body.

54. The system of claim 48, wherein the coaptation assist body further comprises axial struts which inhibit axial bending.

55. The system of claim 48, wherein the coaptation assist body further comprises a ventricular anchor.

56. The system of claim 55, wherein a coupler is located between the coaptation assist body and the ventricular anchor.

57. The system of claim 55, wherein the ventricular anchor extends through a hub, the hub operably connected along the axis of the coaptation assist body.

58. The system of claim 48, wherein the coaptation assist body further comprises a fluid absorbing core.

59. The system of claim 58, wherein the fluid absorbing core has a small volume configuration prior to implantation.

60. The system of claim 48, further comprising a structural mounting to facilitate in situ assembly of the coaptation assist body and the first anchor.

61. A coaptation assist implant for treating mal-coaptation of a heart valve of a heart in a patient, the heart valve having an annulus, first and second leaflets, and first and second commussures, the annulus defining a valve axis extending along a blood flow path, the first and second leaflets having a coaptation zone with a mal-coaptation geometry, the implant comprising:

a coaptation assist body having an axis and first and second opposed major coaptation surfaces, each opposed major coaptation surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body supportable within the heart so that the axis of the implant extends along the axis of the valve with the first and second lateral edges of the coaptation assist body extend along the coaptation zone;

wherein the coaptation assist body of the implant is sufficiently conformable that engagement between the implant and the leaflets of the heart significantly conforms a shape of the coaptation assist body between the leaflets toward the mal-coaptation geometry of the leaflets,

wherein the coaptation assist body further comprises a ventricular anchor extending through a hub, the hub operably connected along the axis of the coaptation assist body.

62. The system of claim 61, further comprising a first anchor selectively deployable from within the heart with a catheter system at a first target location of the heart near the first commissure.

63. The system of claim 62, further comprising a second anchor selectively deployable from within the heart with the catheter system at a second target location of the heart near the second commissure.

64. The system of claim 63, wherein the coaptation assist body further comprises an atrial support disposed between the first anchor and the second anchor.

65. The system of claim 63, further comprising a first crimp that receives a portion of the first anchor and a second crimp that receives a portion of the second anchor, the first crimp and the second crimp operably connected to an atrial support extending laterally from the coaptation assist body.

66. The system of claim 62, further comprising structural mountings to facilitate in situ assembly of the coaptation assist body and the first anchor.

67. The system of claim 61, wherein the coaptation assist body further comprises axial struts which inhibit axial bending.

68. The system of claim 61, wherein a coupler is located between the coaptation assist body and the ventricular anchor.

69. The system of claim 61, wherein the coaptation assist body further comprises a fluid absorbing core.

70. The system of claim 69, wherein the fluid absorbing core has a small volume configuration prior to implantation.

71. A coaptation assist implant for treating mal-coaptation of a heart valve of a heart in a patient, the heart valve having an annulus, first and second leaflets,and first and second commissures, the annulus defining a valve axis extending along a blood flow path, the first and second leaflets having a coaptation zone with a mal-coaptation geometry, the implant comprising:

a coaptation assist body having an axis and first and second opposed major coaptation surfaces, each opposed major coaptation surface extending laterally between a first lateral edge and a second lateral edge of the coaptation assist body, the coaptation assist body supportable within the heart so that the axis of the implant extends along the axis of the valve with the first and second lateral edges of the coaptation assist body extend along the coaptation zone;

a first anchor selectively deployable from within the heart with a catheter system at a first target location of the heart near the first commissure; and

a first crimp that receives a portion of the first anchor, the first crimp operably connected to an atrial support extending laterally from the coaptation assist body,

wherein the coaptation assist body of the implant is sufficiently conformable that engagement between the implant and the leaflets of the heart significantly conforms a shape of the coaptation assist body between the leaflets toward the mal-coaptation geometry of the leaflets.

72. The system of claim 71, further comprising a second anchor selectively deployable from within the heart with the catheter system at a second target location of the heart near the second commissure.

73. The system of claim 72, wherein the atrial support is disposed between the first anchor and the second anchor.

74. The system of claim 72, further comprising a second crimp that receives a portion of the second anchor, the second crimp operably connected to the atrial support extending laterally from the coaptation assist body.

75. The system of claim 71, wherein the coaptation assist body further comprises axial struts which inhibit axial bending.

76. The system of claim 71, wherein the coaptation assist body further comprises a ventricular anchor.

77. The system of claim 76, wherein a coupler is located between the coaptation assist body and the ventricular anchor.

78. The system of claim 76, wherein the ventricular anchor extends through a hub, the hub operably connected along the axis of the coaptation assist body.

79. The system of claim 71, wherein the coaptation assist body further comprises a fluid absorbing core.

80. The system of claim 79, wherein the fluid absorbing core has a small volume configuration prior to implantation.

81. The system of claim 71, further comprising structural mountings to facilitate in situ assembly of the coaptation assist body and the first anchor.