Devices and methods for heart valve treatment

• US 20040148019A1
• 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., Mortier, Todd J., Schweich, Cyril J. Jr., Schroeder, Richard, Ekvall, Craig, Kalgreen, Jason, Matthees, Edward, Kusz, David
• Granted Patent: US 7,112,219 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
• CPC Class Codes: Y10S 623/904 Heart

Abstract

Devices and methods for improving the function of a valve (e.g., mitral valve) by positioning a spacing filling device outside and adjacent the heart wall such that the device applies an inward force against the heart wall acting on the valve. A substantially equal and opposite force may be provided by securing the device to the heart wall, and/or a substantially equal and opposite outward force may be applied against anatomical structure outside the heart wall. The inward force is sufficient to change the function of the valve, and may increase coaptation of the leaflets, for example. The space filling device may be implanted by a surgical approach, a transthoracic approach, or a transluminal approach, for example. The space filling portion may be delivered utilizing a delivery catheter navigated via the selected approach, and the space filling portion may be expandable between a smaller delivery configuration and a larger deployed configuration.

Claims

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

providing a device comprising at least one expandable protrusion; and

positioning the expandable protrusion in contact with an external surface of the heart wall such that the protrusion exerts an inward force against the heart wall proximate a valve, wherein the force is sufficient to alter valve function.

2. The method of claim 1, further comprising positioning the device such that the device exerts a force substantially opposite to the inward force as a result of securing the device to the heart wall.

3. The method of claim 1, further comprising positioning the device such that the device exerts a force substantially opposite to the inward force on anatomical structure external to the heart wall.

4. The method of claim 1, wherein the inward force is sufficient to draw leaflets of the valve together.

5. The method of claim 4, wherein the valve leaflets define a line of coaptation and positioning the expandable protrusion includes positioning the expandable protrusion such that the inward force is exerted substantially orthogonal to the line of coaptation.

6. The method of claim 1, wherein the valve is a mitral valve.

7. The method of claim 1, further comprising adjusting a position of the device while observing the valve function.

8. The method of claim 1, wherein the inward force is exerted on an annulus of the valve.

9. The method of claim 1, wherein the inward force is sufficient to reposition papillary muscles of the valve.

10. The method of claim 1, further comprising positioning the device outside the epicardium of the heart.

11. The method of claim 10, further comprising positioning the device between the epicardium and the pericardium of the heart.

12. The method of claim 11, further comprising attaching the device to the epicardium.

13. The method of claim 12, further comprising maintaining the device free of the pericardium.

14. The method of claim 1, further comprising delivering the device to the heart via a surgical approach.

15. The method of claim 1, further comprising delivering the device to the heart via a subthoracic approach.

16. The method of claim 15, wherein the subthoracic approach includes a subxiphoid approach.

17. The method of claim 15, wherein the subthoracic approach includes a posterior approach.

18. The method of claim 1, further comprising delivering the device via a transluminal approach.

19. The method of claim 18, wherein the transluminal approach is via the superior or inferior vena cava, the right atrium, the coronary sinus, and a cardiac vein.

20. The method of claim 18, wherein the transluminal approach is via the superior or inferior vena cava, into the right atrium or right atrial appendage, through the right atrial wall and into the pericardial space.

21. The method of claim 18, wherein the transluminal approach is via the aorta, into the left ventricle, through the left ventricular wall, and into the pericardial space.

22. The method of claim 18, wherein the transluminal approach is via the azygos vein.

23. The method of claim 18, wherein the transluminal approach is via the esophagus.

24. The method of claim 2, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

25. The method of claim 3, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

26. The method of claim 1, wherein the inward force is exerted throughout the cardiac cycle.

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

providing a device having at least one protrusion; and

positioning the device relative to the heart such that the at least one protrusion is in contact with an external surface of a heart wall and exerts an inward force against the heart wall proximate the valve and such that the device exerts a force substantially opposite to the inward force against an anatomical structure outside the heart wall.

28. The method of claim 27, wherein the at least one protrusion exerts an inward force sufficient to alter valve function.

29. The method of claim 27, wherein the inward force is sufficient to draw leaflets of the valve together.

30. The method of claim 29, 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.

31. The method of claim 27, wherein the valve is a mitral valve.

32. The method of claim 27, further comprising adjusting a position of the device while observing the valve function.

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

34. The method of claim 27, wherein the inward force is sufficient to reposition papillary muscles of the valve.

35. The method of claim 27, further comprising positioning the device outside the epicardium of the heart.

36. The method of claim 35, further comprising positioning the device between the epicardium and the pericardium of the heart.

37. The method of claim 36, further comprising attaching the device to the epicardium.

38. The method of claim 37, further comprising maintaining the device free of the pericardium.

39. The method of claim 27, further comprising delivering the device to the heart via a surgical approach.

40. The method of claim 27, further comprising delivering the device to the heart via a subthoracic approach.

41. The method of claim 40, wherein the subthoracic approach includes a subxiphoid approach.

42. The method of claim 40, wherein the subthoracic approach includes a posterior approach.

43. The method of claim 27, further comprising delivering the device via a transluminal approach.

44. The method of claim 43, wherein the transluminal approach is via the superior or inferior vena cava, the right atrium, the coronary sinus, and a cardiac vein.

45. The method of claim 43, wherein the transluminal approach is via the superior or inferior vena cava, into the right atrium or right atrial appendage, through the right atrial wall and into the pericardial space.

46. The method of claim 43, wherein the transluminal approach is via the aorta, into the left ventricle, through the left ventricular wall, and into the pericardial space.

47. The method of claim 43, wherein the transluminal approach is via the azygos vein.

48. The method of claim 43, wherein the transluminal approach is via the esophagus.

49. The method of claim 27, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

50. The method of claim 27, wherein the inward force is exerted throughout the cardiac cycle.

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

a first anchoring member;

a second anchoring member;

a flexible member configured to connect the first and second anchoring member, the flexible member being further configured to be positioned adjacent an external surface of a heart wall; and

at least one protrusion configured to be positioned in contact with an external surface of the heart wall such that the at least one protrusion exerts an inward force against the heart wall proximate a valve,

wherein the inward force is sufficient to alter valve function.

52. The device of claim 51, wherein the device is configured such that the device exerts a force substantially opposite to the inward force by securing the device to the heart wall.

53. The device of claim 51, wherein the device is configured such that the device exerts a force substantially opposite to the inward force against anatomical structure outside the heart wall.

54. The device of claim 51, wherein the protrusion is expandable.

55. The device of claim 54, wherein the protrusion is inflatable.

56. The device of claim 55, wherein the protrusion includes a balloon.

57. The device of claim 54, wherein the protrusion defines an interior.

58. The device of claim 57, further comprising a coil disposed in the interior of the protrusion.

59. The device of claim 57, further comprising a foam disposed in the interior of the protrusion.

60. The device of claim 57, further comprising a sponge disposed in the interior of the protrusion.

61. The device of claim 57, further comprising a liquid disposed in the interior of the protrusion.

62. The device of claim 61, wherein the liquid is a curable liquid.

63. The device of claim 57, further comprising a mechanical reinforcement member disposed in the interior of the protrusion.

64. The device of claim 57, further comprising means for selectively adding or removing material from the interior.

65. The device of claim 64, wherein the means is transdermally accessible.

66. The device of claim 51, wherein the at least one protrusion comprises a plurality of protrusions.

67. The device of claim 66, wherein the plurality of protrusions form an integral structure.

68. The device of claim 66, wherein the plurality of protrusions are separate from each other.

69. The device of claim 66, wherein the plurality of protrusions are arranged so as to avoid cardiac veins and coronary arteries when positioned in contact with the heart wall.

70. The device of claim 51, wherein the at least one protrusion protrudes from the flexible member.

71. The device of claim 51, wherein the at least one protrusion is expandable between a relatively small delivery configuration and a relatively large deployed configuration.

72. The device of claim 51, wherein the device is configured to be delivered to the heart via a delivery catheter.

73. The device of claim 72, wherein the device is configured to be releasably connected to the delivery catheter.

74. The device of claim 51, wherein the at least one protrusion is configured to exert an inward force sufficient to draw leaflets of the valve together.

75. The device of claim 51, wherein the anchoring members are configured to secure the device to the heart.

76. The device of claim 52, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

77. The device of claim 53, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

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

providing a device comprising a first anchoring member, a second anchoring member, a flexible member connecting the first and second anchoring member, and at least one protrusion between the first and second anchor;

positioning the flexible member adjacent an external surface of a heart wall; and

positioning the at least one protrusion in contact with an external surface of the heart wall such that the at least one protrusion exerts an inward force against the heart wall proximate a valve, wherein the inward force is sufficient to alter valve function.

79. The method of claim 78, further comprising positioning the device such that the device exerts a force substantially opposite to the inward force as a result of securing the device to the heart wall.

80. The method of claim 78, further comprising positioning the device such that the device exerts a force substantially opposite to the inward force on anatomical structure external to the heart wall.

81. The method of claim 78, wherein the inward force is sufficient to draw leaflets of the valve together.

82. The method of claim 81, 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.

83. The method of claim 78, wherein the valve is a mitral valve.

84. The method of claim 78, further comprising adjusting a position of the device while observing the valve function.

85. The method of claim 78, wherein the inward force is exerted on an annulus of the valve.

86. The method of claim 78, wherein the inward force is sufficient to reposition papillary muscles of the valve.

87. The method of claim 78, further comprising positioning the device outside the epicardium of the heart.

88. The method of claim 87, further comprising positioning the device between the epicardium and the pericardium of the heart.

89. The method of claim 88, further comprising attaching the device to the epicardium.

90. The method of claim 89, further comprising maintaining the device free of the pericardium.

91. The method of claim 78, further comprising delivering the device to the heart via a surgical approach.

92. The method of claim 78, further comprising delivering the device to the heart via a subthoracic approach.

93. The method of claim 92, wherein the subthoracic approach includes a subxiphoid approach.

94. The method of claim 92, wherein the subthoracic approach includes a posterior approach.

95. The method of claim 78, further comprising delivering the device via a transluminal approach.

96. The method of claim 95, wherein the transluminal approach is via the superior or inferior vena cava, the right atrium, the coronary sinus, and a cardiac vein.

97. The method of claim 95, wherein the transluminal approach is via the superior or inferior vena cava, into the right atrium or right atrial appendage, through the right atrial wall and into the pericardial space.

98. The method of claim 95, wherein the transluminal approach is via the aorta, into the left ventricle, through the left ventricular wall, and into the pericardial space.

99. The method of claim 95, wherein the transluminal approach is via the azygos vein.

100. The method of claim 95, wherein the transluminal approach is via the esophagus.

101. The method of claim 79, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

102. The method of claim 80, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

103. The method of claim 78, wherein the inward force is exerted throughout the cardiac cycle.

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

at least one protrusion configured to be placed in contact with an external surface of a heart wall and to exert an inward force against the heart wall proximate the valve,

wherein the device is configured to exert a force substantially opposite to the inward force against an anatomical structure outside the heart wall.

105. The device of claim 104, wherein the at least one protrusion is configured to exert an inward force sufficient to alter valve function.

106. The device of claim 104, wherein the inward force is sufficient to draw leaflets of the valve together.

107. The device of claim 104, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

116. The device of claim 104, wherein the elongate member is configured to be positioned adjacent the external surface of the heart when the device is secured relative to the heart.

117. The device of claim 104, wherein the vacuum chambers are configured to be selectively placed in fluid communication with vacuum tubes of a delivery catheter.

118. The device of claim 104, wherein the piercing members are configured to be remotely actuatable.

119. The device of claim 118, wherein the piercing members are configured to be releasably connectable to push-pull wires of a delivery catheter for remote actuation.

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

a substantially elongate member having a first end and a second end;

an anchoring member associated with each of the first end and the second end and configured to secure the device relative to the heart,

wherein each of the anchoring members includes

a vacuum chamber, and

a piercing member configured to pierce tissue.

109. The device of claim 108, wherein the piercing member includes a pin.

110. The device of claim 108, wherein the piercing member is remotely actuatable.

111. The device of claim 108, further comprising a protrusion disposed between the anchoring members and configured to be disposed adjacent an external surface of a heart wall when the device is secured with respect to the heart.

112. The device of claim 111, wherein the protrusion is configured to exert an inward force on the heart wall when the device is secured with respect to the heart.

113. The device of claim 112, wherein the protrusion is configured to exert an inward force on the heart wall proximate a valve, the inward force being sufficient to alter a function of the valve.

114. The device of claim 111, wherein the protrusion is expandable.

115. The device of claim 114, wherein the protrusion is inflatable.

120. A catheter for transthoracic delivery of an implant to the heart, the catheter comprising:

an elongate shaft having a proximal end and a distal end;

a vacuum lumen extending through the elongate shaft;

a suction cup disposed proximate the distal end, the suction cup defining an interior configured to be in fluid communication with the vacuum lumen;

a guide wire tube extending through the suction cup and configured to slidably receive a first guide wire; and

a second guide wire extending alongside the elongate shaft and having an end connected to the suction cup.

121. A delivery catheter comprising:

an inflation tube defining an inflation lumen configured to be placed in fluid communication with an inflation source at a proximal end and with an inflatable structure at a distal end;

first and second vacuum tubes disposed on opposite sides of the inflation tube, each vacuum tube defining a vacuum lumen configured to be placed in fluid communication with a vacuum source at a proximal end and with a vacuum chamber at a distal end; and

a wire extending through each vacuum tube, each wire being configured to be selectively advanced or retracted through the vacuum tube so as to actuate an actuatable member.

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

means for exerting an inward force on an external surface of a heart wall proximate a valve, the inward force being sufficient to alter valve function; and

means for exerting a force substantially opposite the inward force on anatomical structure outside the heart wall.

123. The device of claim 122, wherein the means for exerting a force substantially opposite the inward force includes a means for exerting a force substantially equal to the inward force.

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

a substantially elongate member having a first end and a second end and configured to be positioned external to a heart chamber; and

an anchoring member associated with each of the first end and the second end and configured to secure the device relative to the heart,

wherein the anchoring members are configured to be remotely securable to a wall of heart.