Devices and methods for heart valve treatment

• US 20060247491A1
• Filed: 04/27/2005
• Published: 11/02/2006
• Est. Priority Date: 04/27/2005
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Inventors: Ekvall, Craig A., Vidlund, Robert M., Schweich, Cyril J. Jr., Kusz, David A., Santer, Jeffrey D.
• Application Number:
  US11/115,409
• Publication Number:
  US 20060247491A1
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• 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 securing an implant to body tissue, the device comprising:

a cup defining a chamber and an opening leading to the chamber; and

a tissue piercing mechanism configured to rotate relative to the cup such that the tissue piercing mechanism rotates from a first position wherein the tissue piercing mechanism is substantially within the chamber to a second position wherein the tissue piercing mechanism lies substantially over the opening.

2. The device of claim 1, wherein the chamber includes a suction chamber.

3. The device of claim 1, wherein the tissue piercing mechanism comprises a plurality of tissue piercing pins.

4. The device of claim 3, wherein the pins are curved.

5. The device of claim 4, wherein an inner surface of the cup substantially opposite the opening and defining the chamber is curved such that the inner surface and the pins have substantially the same curvature.

6. The device of claim 3, wherein the tissue piercing mechanism comprises an arm connecting the plurality of tissue piercing pins.

7. The device of claim 6, wherein the arm extends in a direction substantially transverse the plurality of tissue piercing pins.

8. The device of claim 6, wherein the arm is connected to a pivot mechanism configured to rotate the arm and tissue piercing mechanism relative to the cup.

9. The device of claim 1, wherein in the first position, the tissue piercing mechanism is configured so as to allow tissue to enter the chamber.

10. The device of claim 1, wherein in the second position, the tissue piercing mechanism is configured to secure the device to the tissue.

11. The device of claim 1, wherein the tissue piercing mechanism is configured to pierce heart wall tissue.

12. The device of claim 1, wherein the tissue piercing mechanism is configured to be lockable in the second position so as to prevent rotation back to the first position.

13. The device of claim 1, wherein in the first position, a portion of the tissue piercing mechanism is configured to lie adjacent an inner surface of the cup defining the chamber.

14. The device of claim 1, wherein the tissue piercing mechanism is remotely actuatable.

15. The device of claim 1, wherein the tissue piercing mechanism is remotely actuatable via a torque cable.

16. The device of claim 1, further comprising a tissue ingrowth promoting material in cover relation to at least a portion of the device.

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

an elongate member having a first end and a second end; 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 each of the anchoring members comprises

a cup defining a chamber and an opening leading to the chamber; and

a tissue piercing mechanism configured to rotate relative to the cup such that the tissue piercing mechanism rotates from a first position wherein the tissue piercing mechanism is substantially within the chamber to a second position wherein the tissue piercing mechanism lies substantially over the opening.

18. The device of claim 17, wherein the tissue piercing mechanism includes a plurality of tissue piercing pins.

19. The device of claim 17, wherein the tissue piercing mechanism is remotely actuatable.

20. The device of claim 19, wherein the tissue piercing mechanism is remotely actuatable via a torque cable.

21. The device of claim 17, 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.

22. The device of claim 21, wherein the protrusion is configured to exert an inward force on the heart wall proximate a valve when the device is secured relative to the heart, the inward force being sufficient to alter a function of the valve.

23. The device of claim 17, wherein the chambers are suction chambers.

24-36. -36. (canceled)

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

a first catheter configured to simultaneously deliver to the heart an elongate member and a first anchor mechanism attached to a first end of the elongate member;

a second catheter configured to advance an intermediate component along the elongate member until the intermediate component is adjacent the first anchor mechanism; and

a third catheter configured to advance a second anchor mechanism along the elongate member to a position adjacent the intermediate component and on a side of the intermediate component opposite the first anchor mechanism.

38. The delivery system of claim 37, wherein the first catheter comprises a tube defining a lumen configured to receive the elongate member and a shaft configured to releasably connect to the first anchor mechanism.

39. The delivery system of claim 38, wherein the shaft defines a suction lumen.

40. The delivery system of claim 39, wherein the suction lumen is configured to be placed in fluid communication with a chamber defined by the first anchor mechanism.

41. The delivery system of claim 38, wherein the tube comprises a slit along a length of the tube configured to permit removal of the elongate member from the tube lumen.

42. The delivery system of claim 37, wherein the first catheter comprises an actuator for releasing the first anchor mechanism.

43. The delivery system of claim 37, wherein the first catheter comprises an actuator configured to actuate the first anchor mechanism such that it becomes secured to the heart.

44. The delivery system of claim 37, wherein the third catheter comprises a tube defining a lumen and a shaft configured to releasably connect to the second anchor mechanism.

45. The delivery system of claim 44, wherein the shaft defines a suction lumen.

46. The delivery system of claim 45, wherein the suction lumen is configured to be placed in fluid communication with a chamber defined by the second anchor mechanism.

47. The delivery system of claim 44, wherein the tube comprises a slit along a length of the tube.

48. The delivery system of claim 37, wherein the third catheter comprises an actuator for releasing the second anchor mechanism.

49. The delivery system of claim 37, wherein the third catheter comprises an actuator configured to actuate the second anchor mechanism such that it becomes secured to the heart.

50. The delivery system of claim 37, wherein the second catheter comprises a shaft having a distal end configured to abut the intermediate component so as to push the intermediate component along the elongate member.

51. The delivery system of claim 50, wherein the shaft defines a lumen configured to receive the elongate member.

52. The delivery system of claim 37, further comprising a tightening device for adjusting a length of the elongate member between the first and second anchor mechanisms when implanted in the heart.

53. The delivery system of claim 52, wherein the tightening device comprises an actuator to actuate a securing member to secure the second anchor mechanism to the elongate member.

54. The delivery system of claim 37, further comprising an access device for providing access to the pericardial space.

55. The delivery system of claim 37, wherein the system is configured to access the pericardial space so as to deliver the implant to the pericardial space.

56. The delivery system of claim 37, wherein the system is configured to deliver an implant configured to treat a heart valve.

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

an 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 such that the device provides a compressive force to an exterior portion of the heart sufficient to alter valve function; and

an intermediate component comprising a sleeve configured to be advanced over the elongate member and to be positioned between each anchoring member when the device is implanted in the heart, the sleeve being configured to distribute the force applied by the elongate member to the heart.

58. The device of claim 57, wherein the sleeve comprises expanded polytetrafluoroethylene (ePTFE).

59. The device of claim 57, wherein the intermediate component comprises two sleeves.

60. The device of claim 59, wherein the intermediate component comprises a protrusion configured to be positioned between the two sleeves.

61. The device of claim 60, wherein the protrusion is configured to at least partially provide the compressive force sufficient to alter valve function.

62. The device of claim 57, wherein the intermediate component comprises a protrusion, the protrusion being configured to at least partially provide the compressive force sufficient to alter valve function.

63. The device of claim 57, wherein the sleeve is deformable.

64. The device of claim 57, wherein the sleeve is configured to conform to coronary vasculature.

65. The device of claim 57, wherein the sleeve is a tubular sleeve.

66. The device of claim 62, wherein the height of the sleeve approximates the height of the protrusion as measured in a direction substantially transverse to the elongate member.

67-83. -83. (canceled)

84. A system for treating a heart valve, the system comprising:

an access device configured to access the pericardial space from a remote location, a portion of the access device being configured to be automatically inserted through the pericardium to a predetermined depth beyond the pericardium and to separate the pericardium from the epicardium; and

an implant configured to be delivered to the pericardial space and to be secured relative to the heart so as to exert a compressive force on the heart sufficient to alter valve function.

85. The system of claim 84, wherein the access device is configured to separate the pericardium from the epicardium without the use of suction.

86. The system of claim 84, wherein the portion of the access device includes a distal portion of the access device.

87. The system of claim 86, wherein the distal portion comprises a dilation member and a region of reduced cross-section proximal the dilation member.

88. The system of claim 87, wherein the access device includes a shoulder proximal the region of reduced cross-section, the shoulder being configured to abut the pericardium such that the shoulder cannot be inserted past the pericardium.

89. The system of claim 87, wherein the access device is configured such that once the dilation member is inserted past the pericardium, moving the access device in a proximal direction causes the dilation member to separate the pericardium from the epicardium.

90. The system of claim 87, wherein the dilation member is configured to elastically dilate the pericardium.

91. The system of claim 90, wherein the dilation member is configured to elastically dilate the pericardium by an amount such that the dilation member can separate the pericardium from the epicardium without tearing the pericardium upon moving the access device in a proximal direction.

92. The system of claim 87, wherein the dilation member is configured to dilate the pericardium during insertion by an amount such that the pericardium elastically recoils around the region of reduced cross-section.

93. The system of claim 84, further comprising a dilating tool configured to dilate the pericardium prior to delivering the implant to the pericardial space.

94. The system of claim 84, wherein the portion of the access device includes a region of enlarged cross-section configured to engage the pericardium to separate the pericardium from the epicardium upon moving the portion in a proximal direction.

95. The system of claim 84, further comprising a stylet configured to pierce the pericardium.

96. The system of claim 95, wherein the access device includes a trocar and the stylet is configured to carry the trocar during insertion of the trocar through the pericardium.

97. The system of claim 84, wherein the access device includes a trocar and the system further comprises a stylet configured to carry the trocar during insertion of the trocar through the pericardium.

98. The system of claim 97, wherein the stylet is configured to be removed from the trocar prior to delivering the implant.

99. The system of claim 84, further comprising a guidewire configured to be delivered to the pericardial space via the access device.

100. The system of claim 99, wherein the guidewire is configured to deliver the implant to the pericardial space.