Devices and methods for heart valve treatment

• US 20040148020A1
• Filed: 11/10/2003
• Published: 07/29/2004
• Est. Priority Date: 11/12/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Vidlund, Robert M., Schweich, Cyril J. Jr., Ekvall, Craig, Kusz, David
• Granted Patent: US 7,247,134 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• 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 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• 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 2/2481 Devices outside the heart wall, e.g. bags, strips or bands

Abstract

Devices and methods for improving the function of a valve (e.g., mitral valve) by positioning an implantable device outside and adjacent the heart wall such that the device alters the shape of the heart wall acting on the valve. The implantable device may alter the shape of the heart wall acting on the valve by applying an inward force and/or by circumferential shortening (cinching). The shape change of the heart wall acting on the valve is sufficient to change the function of the valve, and may increase coaptation of the leaflets, for example, to reduce regurgitation.

Claims

1. A device for improving heart valve function, the device comprising:

a first anchor configured to be secured to heart tissue;

a second anchor configured to be secured to heart tissue; and

an interconnecting member connecting the first anchor and the second anchor,

wherein the interconnecting member is configured to be selectively adjustable so as to alter a tension of the interconnecting member between the first anchor and the second anchor, and

wherein at least a portion of the interconnecting member is configured to be positioned in contact with an external surface of a heart wall proximate a valve such that the device exerts an inward force on the heart wall sufficient to alter the valve function.

2. The device of claim 1, wherein the interconnecting member is flexible.

3. The device of claim 1, wherein the interconnecting member is made of a plurality of filaments.

4. The device of claim 3, wherein the plurality of filaments form a braided structure.

5. The device of claim 1, further comprising a covering provided on the interconnecting member.

6. The device of claim 5, wherein the covering is biocompatible.

7. The device of claim 5, wherein the covering is configured to promote tissue ingrowth.

8. The device of claim 5, wherein the covering comprises an atraumatic pad.

9. The device of claim 1, wherein each of the first and second anchors defines a vacuum chamber.

10. The device of claim 1, further comprising a tissue penetrating member associated with each of the first anchor and the second anchor.

11. The device of claim 10, wherein the tissue penetrating members comprise selectively actuatable pins.

12. The device of claim 1, wherein the first anchor and the second anchor are configured to be positioned to avoid coronary arteries and coronary veins when the device is implanted relative to the heart.

13. The device of claim 1, wherein the interconnecting member is configured to be adjustably connected to at least one of the first and second anchors.

14. The device of claim 13, wherein the interconnecting member is configured to be selectively lockable relative to the at least one first and second anchor.

15. The device of claim 14, further comprising a pin configured to selectively penetrate the interconnecting member so as to selectively lock the interconnecting member to the at least one first and second anchor.

16. The device of claim 13, wherein the interconnecting member is configured to be adjustably connected to the first anchor and to the second anchor.

17. The device of claim 13, wherein the interconnecting member is configured to be adjustably connected to one of the first anchor and the second anchor and fixedly connected to the other of the first anchor and the second anchor.

18. The device of claim 1, wherein the device is configured to be delivered to the heart via a delivery catheter.

19. The device of claim 1, wherein the first anchor and the second anchor are configured to be secured to an epicardial layer of the heart.

20. The device of claim 19, wherein the first anchor and the second anchor are configured to be secured to the epicardial layer while the anchors remain free from a pericardial layer of the heart.

21. The device of claim 19, wherein at least one of the first anchor and the second anchor is configured to be secured to the pericardial layer of the heart.

22. The device of claim 1, further comprising least one protrusion connected to the interconnecting member and configured to be positioned between the first anchor and the second anchor.

23. A method for improving heart valve function, the method comprising:

providing a device comprising a first anchor configured to be secured to heart tissue, a second anchor configured to be secured to heart tissue, and an interconnecting member connecting the first anchor and the second anchor; and

positioning at least a portion of the interconnecting member in contact with an external surface of a heart wall proximate a valve such that the device exerts an inward force on the heart wall sufficient to alter the valve function,

wherein the interconnecting member is configured to be selectively adjustable so as to alter a tension of the interconnecting member between the first anchor and the second anchor.

24. The method of claim 23, wherein the inward force is sufficient to draw leaflets of the valve together.

25. The method of claim 24, wherein the valve leaflets define a line of coaptation and positioning the portion of the interconnecting member includes positioning the portion such that the inward force is exerted substantially orthogonal to the line of coaptation.

26. The method of claim 23, wherein the valve is a mitral valve.

27. The method of claim 23, wherein the inward force is exerted on an annulus of the valve.

28. The method of claim 23, wherein the inward force is sufficient to reposition papillary muscles of the valve.

29. The method of claim 23, further comprising positioning the device outside the epicardium of the heart.

30. The method of claim 23, further comprising selectively adjusting the tension of the interconnecting member.

31. The method of claim 23, further comprising adjusting a relative position of the first and second anchors so as to adjust the tension in the interconnecting member.

32. The method of claim 31, further comprising selectively locking the interconnecting member to at least one of the first anchor and the second anchor after adjusting the relative position.

33. The method of claim 32, wherein the selectively locking includes penetrating the interconnecting member with a pin.

34. The method of claim 23, further comprising securing the first anchor and the second anchor to an epicardial layer of the heart.

35. The method of claim 34, wherein the securing includes securing the first anchor and the second anchor to the epicardial layer while the anchors remain free from a pericardial layer of the heart.

36. The method of claim 34, further comprising securing at least one of the first anchor and the second anchor to a pericardial layer of the heart.

37. The method of claim 23, further comprising delivering the device to the heart via a delivery catheter.

38. The method of claim 23, further comprising securing the first and second anchors to the heart tissue via tissue penetrating members.

39. The method of claim 38, further comprising remotely actuating the tissue penetrating members.

40. The method of claim 23, further comprising exerting the inward force on the heart wall throughout a cardiac cycle.

41. The method of claim 23, further comprising delivering the device to the heart via one of a surgical, transluminal, and transthoracic approach.

42. The method of claim 41, wherein the delivering comprises delivering the device via a transthoracic subxiphoid approach.

43. The method of claim 23, wherein providing the device includes providing a device comprising at least one protrusion connected to the interconnecting member and disposed between the first anchor and the second anchor.

44. A device for improving heart valve function, the device comprising:

a first anchor configured to be secured to heart tissue;

a second anchor configured to be secured to heart tissue;

a protrusion disposed between the first anchor and the second anchor; and

an interconnecting member connecting the first anchor, the protrusion, and the second anchor,

wherein the interconnecting member is configured to be selectively adjustable so as to alter relative positions between at least one of the first and second anchor and the protrusion, and

wherein the protrusion is configured to be positioned adjacent an external surface of a heart wall proximate a valve so as to exert an inward force on the heart wall and alter the valve function.

45. The device of claim 44, wherein the interconnecting member is made of a plurality of filaments.

46. The device of claim 45, wherein the plurality of filaments form a braided structure.

47. The device of claim 44, further comprising a covering provided on the interconnecting member.

48. The device of claim 47, wherein the covering is biocompatible.

49. The device of claim 47, wherein the covering is configured to promote tissue ingrowth.

50. The device of claim 47, wherein the covering comprises an atraumatic pad.

51. The device of claim 44, wherein the protrusion is one of fixedly and adjustably connected to the interconnecting member.

52. The device of claim 44, wherein the protrusion comprises an expandable structure.

53. The device of claim 52, wherein the expandable structure is configured to be selectively expandable after implantation of the device relative to the heart.

54. The device of claim 52, wherein the protrusion comprises an inflatable structure.

55. The device of claim 54, wherein the protrusion comprises a balloon.

56. The device of claim 44, wherein the protrusion comprises an outer surface configured to promote tissue ingrowth.

57. The device of claim 44, further comprising a plurality of protrusions connected to the interconnecting member and disposed between the first and second anchors.

58. The device of claim 44, wherein each of the first and second anchors defines a vacuum chamber.

59. The device of claim 44, further comprising a tissue penetrating member associated with each of the first anchor and the second anchor.

60. The device of claim 59, wherein the tissue penetrating members comprise selectively actuatable pins.

61. The device of claim 44, wherein the interconnecting member defines a plurality of pockets.

62. The device of claim 61, wherein the pockets are configured to selectively receive a structure forming the protrusion.

63. The device of claim 44, wherein the first anchor, the second anchor, and the protrusion are configured to be positioned so as to avoid coronary arteries and coronary veins when the device is implanted relative to the heart.

64. The device of claim 44, wherein the protrusion is rotatably connected to the interconnecting member.

65. The device of claim 64, wherein the protrusion is rotatable relative to the interconnecting member between a relatively low profile delivery configuration and a larger profile deployed configuration.

66. The device of claim 65, wherein the protrusion extends substantially along an axis of the interconnecting member in the delivery configuration and extends substantially perpendicular to the axis of the interconnecting member in the deployed configuration.

67. The device of claim 66, further comprising a pair of protrusions disposed on opposite sides of the rotatable protrusion.

68. The device of claim 44, wherein the interconnecting member is configured to be adjustably connected to at least one of the first and second anchors.

69. The device of claim 68, wherein the interconnecting member is configured to be selectively lockable relative to the at least one first and second anchor.

70. The device of claim 69, further comprising a pin configured to selectively penetrate the interconnecting member so as to selectively lock the interconnecting member to the at least one first and second anchor.

71. The device of claim 68, wherein the interconnecting member is configured to be adjustably connected to the first anchor and to the second anchor.

72. The device of claim 68, wherein the interconnecting member is configured to be adjustably connected to one of the first anchor and the second anchor and fixedly connected to the other of the first anchor and the second anchor.

73. The device of claim 44, wherein the interconnecting member is configured to be adjustably connected to the protrusion and fixedly connected to the first anchor and to the second anchor.

74. The device of claim 44, wherein the device is configured to be delivered to the heart via a delivery catheter.

75. The device of claim 44, wherein the interconnecting member comprises a first interconnecting member connecting the protrusion to the first anchor and a second interconnecting member connecting the protrusion to the second anchor.

76. A method for improving heart valve function, the method comprising:

providing a device having a first anchor configured to be secured to heart tissue, a second anchor configured to be secured to heart tissue, a protrusion disposed between the first anchor and the second anchor, and an interconnecting member connecting the first anchor, the protrusion, and the second anchor; and

positioning the protrusion adjacent an external surface of a heart wall proximate a valve so as to exert an inward force on the heart wall and alter the valve function,

wherein the interconnecting member is configured to be selectively adjustable so as to alter relative positions between at least one of the first and second anchor and the protrusion.

77. The method of claim 76, wherein the inward force is sufficient to draw leaflets of the valve together.

78. The method of claim 77, wherein the valve leaflets define a line of coaptation and positioning the protrusion includes positioning the protrusion such that the inward force is exerted substantially orthogonal to the line of coaptation.

79. The method of claim 76, wherein the valve is a mitral valve.

80. The method of claim 76, wherein the inward force is exerted on an annulus of the valve.

81. The method of claim 76, wherein the inward force is sufficient to reposition papillary muscles of the valve.

82. The method of claim 76, further comprising positioning the device outside the epicardium of the heart.

83. The method of claim 76, further comprising selectively adjusting the tension of the interconnecting member.

84. The method of claim 83, wherein the selectively adjusting the tension includes adjusting the relative position of the first anchor, the second anchor, and the protrusion.

85. The method of claim 84, further comprising selectively locking the interconnecting member to at least one of the first anchor, the second anchor, and the protrusion after adjusting the relative position.

86. The method of claim 85, wherein the selectively locking includes penetrating the interconnecting member with a pin.

87. The method of claim 76, further comprising securing the first anchor and the second anchor to an epicardial layer of the heart.

88. The method of claim 87, wherein the securing includes securing the first anchor and the second anchor to the epicardial layer while the anchors remain free from a pericardial layer of the heart.

89. The method of claim 87, further comprising securing at least one of the first anchor and the second anchor to a pericardial layer of the heart.

90. The method of claim 76, further comprising delivering the device to the heart via a delivery catheter.

91. The method of claim 76, further comprising securing the first and second anchors to the heart tissue via tissue penetrating members.

92. The method of claim 91, further comprising remotely actuating the tissue penetrating members.

93. The method of claim 76, further comprising exerting the inward force on the heart wall throughout a cardiac cycle.

94. The method of claim 76, further comprising delivering the device to the heart via one of a surgical, transluminal, and transthoracic approach.

95. The method of claim 94, wherein the delivering comprises delivering the device via a transthoracic subxiphoid approach.

96. The method of claim 76, wherein the protrusion is expandable and the method further comprises selectively expanding the protrusion.

97. The method of claim 76, wherein providing the device includes providing a device further comprising a first interconnecting member portion connecting the first anchor to the protrusion and a second interconnecting member connecting the second anchor to the protrusion.

98. A device for improving valve function, the device comprising:

a first anchor, at least a portion of the first anchor being remotely actuatable so as to embed into heart tissue;

a second anchor, at least a portion of the second anchor being remotely actuatable so as to embed into heart tissue;

an interconnecting member connecting the first anchor and the second anchor,

wherein the interconnecting member is configured to be selectively adjustable so as to alter a tension of the interconnecting member between the first anchor and the second anchor, and

wherein the device is configured to be positioned adjacent an external surface of a heart wall proximate a valve so as to exert an inward force on the heart wall sufficient to alter the valve function.

99. The device of claim 98, wherein the portion of the first anchor and the portion of the second anchor comprise tissue penetrating members.

100. The device of claim 99, wherein the tissue penetrating members are pins.

101. The device of claim 98, wherein the portion of the first anchor and the portion of the second anchor are configured to be remotely actuable via push-pull members associated with a catheter.

102. The device of claim 98, wherein the first anchor and the second anchor define vacuum chambers.

103. A securement device, the device comprising:

a pin configured to penetrate a structure to be secured, the pin comprising a shaft and a piercing tip, wherein a recess is defined between the shaft and the piercing tip; and

a multifilament material associated with the pin,

wherein the multifilament material and pin are configured to permit the piercing tip to pass through the material in a first direction and prevent the piercing tip from passing through the material in a second direction opposite to the first direction.

104. The device of claim 103, wherein the material is configured to be disposed in the recess so as to prevent the piercing tip from passing through the material in the second direction.

105. The device of claim 103, wherein the material has a braided configuration.

106. A delivery system for delivering an implant to a heart, the delivery system comprising:

at least one anchor catheter, the anchor catheter comprising;

a shaft defining a vacuum lumen;

at least one actuatable push rod configured to actuate a securing member associated with the implant;

a side tube extending alongside the shaft and configured to receive an elongate member for implanting relative to the heart; and

a releasable connection configured to be releasably connected to a portion of the implant.

107. The delivery system of claim 106, further comprising two anchor catheters.

108. The delivery system of claim 106, wherein a distal end of the shaft is configured to be bi-directionally laterally deflectable.

109. A delivery system for delivering an implant to a heart, the delivery system comprising:

a delivery catheter configured to be releasably connected to the implant, the delivery catheter comprising

a shaft defining an inflation lumen and two cable lumens, and

a pair of push tubes extending alongside the shaft and configured to

slidably receive push rods configured to actuate an actuatable member associated with the implant; and

two anchor catheters each disposed on opposite sides of the delivery catheter and configured to be releasably connected to anchors associated with the implant, each anchor catheter comprising

a shaft defining a vacuum lumen,

a push rod configured to be slidably received in the vacuum lumen and configured to actuate an actuatable member associated with a respective anchor, and

a guide lumen extending alongside the shaft and configured to receive a cable.

110. A device for adjusting tension of an elongate member, the device comprising:

a receiving tube for receiving the elongate member, the receiving tube having a proximal end and a distal end;

an engagement mechanism on the distal end of the receiving tube;

a measuring tube having markings thereon connected to the proximal end of the receiving tube;

an inner tube disposed in the measuring tube and configured to be connected to a proximal end of the elongate member for tensioning; and

a lock mechanism connected to the proximal end of the measuring tube configured to selectively lock the inner tube to the measuring tube,

wherein the inner tube is configured to be moved relative to the measuring tube so as to adjust the tension of the elongate member when the elongate member is connected to the inner tube.

111. A device for accessing pericardial space around a heart, the device comprising:

an outer tube defining a lumen and having a handle and a vacuum port;

a securement tube defining a lumen and comprising a plurality of piercing members disposed at a distal end of the securement tube, the securement tube being configured to be received in the lumen of the outer tube; and

a cutter tube defining a lumen and being configured to be received in the lumen of the securement tube, the cutter tube comprising a cutting edge on a distal end thereof and a plurality of vacuum holes proximate the distal end, the cutter tube being advanceable within the securement tube.

112. The device of claim 111, further comprising a visualization device.

113. The device of claim 111, wherein the cutter tube further comprises an annular fluid seal so as to provide a seal between the securement tube and the cutter tube.