Techniques for providing a replacement valve and transseptal communication

• US 10,531,866 B2
• Filed: 02/15/2017
• Issued: 01/14/2020
• Est. Priority Date: 02/16/2016
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Cardiovalve Ltd.
• Inventors: Hariton, Ilia, Reich, Tal, Kaye, Paul
• Primary Examiner(s): Ton, Martin T
• Application Number:
  US15/433,547
• Publication Number:
  US 20170231766A1
• Time in Patent Office: 1,063 Days
• Field of Search: 623 211
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/249 Device completely embedded in the heart wall
• CPC Class Codes: A61F 2210/0057 stretchable
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202

Abstract

A method is provided, comprising: (1) making a transapical puncture into a left ventricle of the heart; (2) making a transseptal fenestration in the heart; (3) delivering a prosthetic valve via the transapical puncture and implanting the prosthetic valve at a mitral valve of the heart; and (4) subsequently to delivering the prosthetic valve and making the transseptal fenestration, closing the transapical puncture. Other embodiments are also described.

Claims

1. A method for use with a heart of a subject, the method comprising:

making a transapical puncture into a left ventricle of the heart;

making a transseptal fenestration in the heart via the transapical puncture;

delivering a prosthetic valve via the transapical puncture and implanting the prosthetic valve at a mitral valve of the heart; and

subsequently to delivering the prosthetic valve and making the transseptal fenestration, closing the transapical puncture.

2. The method according to claim 1, wherein the subject has not been identified as suffering from heart failure, and wherein performing the method comprises performing the method on the subject that has not been identified as suffering from heart failure.

3. The method according to claim 1, wherein making the transseptal fenestration comprises making a fenestration in the interventricular septum.

4. The method according to claim 1, wherein making the transseptal fenestration comprises making a fenestration in the interatrial septum.

5. The method according to claim 1, wherein making the transseptal fenestration comprises making the transseptal fenestration after implanting the prosthetic valve.

6. The method according to claim 1, wherein making the transseptal fenestration comprises making the transseptal fenestration before implanting the prosthetic valve.

7. The method according claim 1, further comprising advancing a distal end of a tube through the transapical puncture, and wherein delivering the prosthetic valve via the transapical puncture comprises delivering the prosthetic valve via the tube.

8. The method according to claim 7, wherein making the transseptal fenestration comprises making the transseptal fenestration via the tube.

9. The method according to claim 1, further comprising implanting a shunt device into the transseptal fenestration.

10. The method according to claim 9, wherein the shunt device includes a check valve, and implanting the shunt device comprises implanting the shunt device such that the check valve facilitates one-way blood flow from a chamber of the left side of the heart, via the transseptal fenestration, to a chamber of the right side of the heart.

11. The method according to claim 9, wherein implanting the shunt device comprises implanting a shunt device that is shaped to define a lumen, and includes a membrane that regulates blood flow through the lumen.

12. The method according to claim 11, wherein implanting the shunt device comprises implanting a shunt device that includes a membrane that (a) has (i) a closed position in which the membrane inhibits blood flow through the lumen, and (ii) an open position in which the inhibiting of the blood flow is reduced, resides in the closed position while a blood pressure difference across the membrane is lower than a threshold blood pressure difference of 4-6 mmHg (e.g., 5 mmHg), and moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference.

13. The method according to claim 12, wherein the membrane moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane, and implanting the shunt device that includes the membrane comprises implanting the shunt device that includes the membrane that moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane.

14. The method according to claim 11, wherein the membrane is transected by intersecting slits, and implanting the shunt device comprises implanting the shunt device that includes the membrane that is transected by intersecting slits.

15. The method according to claim 1, further comprising implanting at the transseptal fenestration, a balloon device that includes a balloon having an interior and an opening into the interior, such that (i) the interior is in fluid communication, via the opening, with a chamber of the left side of the heart, and (ii) a greater blood pressure in the chamber of the left side of the heart relative to a blood pressure in a corresponding chamber of the right side of the heart inflates the balloon such that the balloon reversibly expands into the corresponding chamber of the right side of the heart.

16. The method according to claim 15, wherein the balloon is elastic, and implanting the balloon device comprises implanting the balloon device such that the balloon automatically deflates in response to a reduction in the greater blood pressure in the chamber of the left side of the heart.

17. The method according to claim 15, wherein implanting the balloon device comprises implanting the balloon such that the balloon inflates only when blood pressure in the chamber of the left side of the heart is more than 4-6 mmHg greater than blood pressure in the chamber of the right side of the heart.

18. The method according to claim 15, wherein implanting the balloon device comprises sealing the transseptal fenestration with the balloon device.

19. The method according to claim 1, further comprising implanting at the transseptal fenestration, an elastic membrane that elastically expands in response to a difference in blood pressure across the membrane.

20. The method according to claim 19, wherein implanting the elastic membrane comprises sealing the transseptal fenestration with the elastic membrane.

21. The method according to claim 1, further comprising implanting at the transseptal fenestration, a cell having an interior and an opening into the interior, such that (i) the interior is in fluid communication, via the opening, with a chamber of the left side of the heart, and (ii) a greater blood pressure in the chamber of the left side of the heart relative to a blood pressure in a corresponding chamber of the right side of the heart increases a volume of the interior that is disposed within the corresponding chamber of the right side of the heart.

22. The method according to claim 21, wherein the cell includes an elastic membrane, and implanting the cell comprises implanting the cell that includes the elastic membrane, such that the elastic membrane elastically expands into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

23. The method according to claim 21, wherein the cell is a balloon, and implanting the cell comprises implanting the balloon, such that the balloon expands into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

24. The method according to claim 21, wherein implanting the cell comprises implanting a cell that is slidably mounted in a mount, such that the mount is fixed at the transseptal fenestration, and the cell slides into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

25. The method according to claim 21, wherein implanting the cell comprises implanting the cell such that the volume of the interior that is disposed within the corresponding chamber of the right side of the heart increases only when the blood pressure in the chamber of the left side of the heart is greater than the blood pressure in the chamber of the right side of the heart by more than a threshold difference of 4-6 mmHg.

90. The method according to claim 11, wherein the membrane is transected by intersecting slits, and implanting the shunt device comprises implanting the shunt device that includes the membrane that is transected by intersecting slits.

26. A method for use with a heart of a subject, the method comprising:

making a transapical puncture into a left ventricle of the heart;

making a transseptal fenestration in the heart in the interventricular septum;

delivering a prosthetic valve via the transapical puncture and implanting the prosthetic valve at a mitral valve of the heart; and

subsequently to delivering the prosthetic valve and making the transseptal fenestration, closing the transapical puncture.

27. The method according to claim 26, wherein the subject has not been identified as suffering from heart failure, and wherein performing the method comprises performing the method on the subject that has not been identified as suffering from heart failure.

28. The method according to claim 26, wherein making the transseptal fenestration comprises making the transseptal fenestration via the transapical puncture.

29. The method according to claim 26, wherein making the transseptal fenestration comprises making the transseptal fenestration via a transfemoral route.

30. The method according to claim 26, wherein making the transseptal fenestration comprises making the transseptal fenestration after implanting the prosthetic valve.

31. The method according to claim 26, wherein making the transseptal fenestration comprises making the transseptal fenestration before implanting the prosthetic valve.

32. The method according claim 26, further comprising advancing a distal end of a tube through the transapical puncture, and wherein delivering the prosthetic valve via the transapical puncture comprises delivering the prosthetic valve via the tube.

33. The method according to claim 32, wherein making the transseptal fenestration comprises making the transseptal fenestration via the tube.

34. The method according to claim 26, further comprising implanting a shunt device into the transseptal fenestration.

35. The method according to claim 34, wherein the shunt device includes a check valve, and implanting the shunt device comprises implanting the shunt device such that the check valve facilitates one-way blood flow from a chamber of the left side of the heart, via the transseptal fenestration, to a chamber of the right side of the heart.

36. The method according to claim 34, wherein implanting the shunt device comprises implanting a shunt device that is shaped to define a lumen, and includes a membrane that regulates blood flow through the lumen.

37. The method according to claim 36, wherein implanting the shunt device comprises implanting a shunt device that includes a membrane that (a) has (i) a closed position in which the membrane inhibits blood flow through the lumen, and (ii) an open position in which the inhibiting of the blood flow is reduced, resides in the closed position while a blood pressure difference across the membrane is lower than a threshold blood pressure difference of 4-6 mmHg (e.g., 5 mmHg), and moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference.

38. The method according to claim 37, wherein the membrane moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane, and implanting the shunt device that includes the membrane comprises implanting the shunt device that includes the membrane that moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane.

39. The method according to claim 36, wherein the membrane is transected by intersecting slits, and implanting the shunt device comprises implanting the shunt device that includes the membrane that is transected by intersecting slits.

40. The method according to claim 26, further comprising implanting at the transseptal fenestration, a balloon device that includes a balloon having an interior and an opening into the interior, such that (i) the interior is in fluid communication, via the opening, with a chamber of the left side of the heart, and (ii) a greater blood pressure in the chamber of the left side of the heart relative to a blood pressure in a corresponding chamber of the right side of the heart inflates the balloon such that the balloon reversibly expands into the corresponding chamber of the right side of the heart.

41. The method according to claim 40, wherein the balloon is elastic, and implanting the balloon device comprises implanting the balloon device such that the balloon automatically deflates in response to a reduction in the greater blood pressure in the chamber of the left side of the heart.

42. The method according to claim 40, wherein implanting the balloon device comprises implanting the balloon such that the balloon inflates only when blood pressure in the chamber of the left side of the heart is more than 4-6 mmHg greater than blood pressure in the chamber of the right side of the heart.

43. The method according to claim 40, wherein implanting the balloon device comprises sealing the transseptal fenestration with the balloon device.

44. The method according to claim 26, further comprising implanting at the transseptal fenestration, an elastic membrane that elastically expands in response to a difference in blood pressure across the membrane.

45. The method according to claim 44, wherein implanting the elastic membrane comprises sealing the transseptal fenestration with the elastic membrane.

46. The method according to claim 26, further comprising implanting at the transseptal fenestration, a cell having an interior and an opening into the interior, such that (i) the interior is in fluid communication, via the opening, with a chamber of the left side of the heart, and (ii) a greater blood pressure in the chamber of the left side of the heart relative to a blood pressure in a corresponding chamber of the right side of the heart increases a volume of the interior that is disposed within the corresponding chamber of the right side of the heart.

47. The method according to claim 46, wherein the cell includes an elastic membrane, and implanting the cell comprises implanting the cell that includes the elastic membrane, such that the elastic membrane elastically expands into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

48. The method according to claim 46, wherein the cell is a balloon, and implanting the cell comprises implanting the balloon, such that the balloon expands into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

49. The method according to claim 46, wherein implanting the cell comprises implanting a cell that is slidably mounted in a mount, such that the mount is fixed at the transseptal fenestration, and the cell slides into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

50. The method according to claim 46, wherein implanting the cell comprises implanting the cell such that the volume of the interior that is disposed within the corresponding chamber of the right side of the heart increases only when the blood pressure in the chamber of the left side of the heart is greater than the blood pressure in the chamber of the right side of the heart by more than a threshold difference of 4-6 mmHg.

51. A method for use with a heart of a subject, the method comprising:

making a transapical puncture into a left ventricle of the heart;

delivering a prosthetic valve via the transapical puncture and implanting the prosthetic valve at a mitral valve of the heart;

subsequently to implanting the prosthetic valve, making a transseptal fenestration in the heart; and

subsequently to making the transseptal fenestration, closing the transapical puncture.

52. The method according to claim 51, wherein the subject has not been identified as suffering from heart failure, and wherein performing the method comprises performing the method on the subject that has not been identified as suffering from heart failure.

53. The method according to claim 51, wherein making the transseptal fenestration comprises making the transseptal fenestration via the transapical puncture.

54. The method according to claim 51, wherein making the transseptal fenestration comprises making the transseptal fenestration via a transfemoral route.

55. The method according to claim 51, wherein making the transseptal fenestration comprises making a fenestration in the interventricular septum.

56. The method according to claim 51, wherein making the transseptal fenestration comprises making a fenestration in the interatrial septum.

57. The method according claim 51, further comprising advancing a distal end of a tube through the transapical puncture, and wherein delivering the prosthetic valve via the transapical puncture comprises delivering the prosthetic valve via the tube.

58. The method according to claim 57, wherein making the transseptal fenestration comprises making the transseptal fenestration via the tube.

59. The method according to claim 51, further comprising implanting a shunt device into the transseptal fenestration.

60. The method according to claim 59, wherein the shunt device includes a check valve, and implanting the shunt device comprises implanting the shunt device such that the check valve facilitates one-way blood flow from a chamber of the left side of the heart, via the transseptal fenestration, to a chamber of the right side of the heart.

61. The method according to claim 59, wherein implanting the shunt device comprises implanting a shunt device that is shaped to define a lumen, and includes a membrane that regulates blood flow through the lumen.

62. The method according to claim 61, wherein implanting the shunt device comprises implanting a shunt device that includes a membrane that (a) has (i) a closed position in which the membrane inhibits blood flow through the lumen, and (ii) an open position in which the inhibiting of the blood flow is reduced, resides in the closed position while a blood pressure difference across the membrane is lower than a threshold blood pressure difference of 4-6 mmHg (e.g., 5 mmHg), and moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference.

63. The method according to claim 62, wherein the membrane moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane, and implanting the shunt device that includes the membrane comprises implanting the shunt device that includes the membrane that moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane.

64. The method according to claim 61, wherein the membrane is transected by intersecting slits, and implanting the shunt device comprises implanting the shunt device that includes the membrane that is transected by intersecting slits.

65. The method according to claim 51, further comprising implanting at the transseptal fenestration, a balloon device that includes a balloon having an interior and an opening into the interior, such that (i) the interior is in fluid communication, via the opening, with a chamber of the left side of the heart, and (ii) a greater blood pressure in the chamber of the left side of the heart relative to a blood pressure in a corresponding chamber of the right side of the heart inflates the balloon such that the balloon reversibly expands into the corresponding chamber of the right side of the heart.

66. The method according to claim 65, wherein the balloon is elastic, and implanting the balloon device comprises implanting the balloon device such that the balloon automatically deflates in response to a reduction in the greater blood pressure in the chamber of the left side of the heart.

67. The method according to claim 65, wherein implanting the balloon device comprises implanting the balloon such that the balloon inflates only when blood pressure in the chamber of the left side of the heart is more than 4-6 mmHg greater than blood pressure in the chamber of the right side of the heart.

68. The method according to claim 65, wherein implanting the balloon device comprises sealing the transseptal fenestration with the balloon device.

69. The method according to claim 51, further comprising implanting at the transseptal fenestration, an elastic membrane that elastically expands in response to a difference in blood pressure across the membrane.

70. The method according to claim 69, wherein implanting the elastic membrane comprises sealing the transseptal fenestration with the elastic membrane.

71. The method according to claim 51, further comprising implanting at the transseptal fenestration, a cell having an interior and an opening into the interior, such that (i) the interior is in fluid communication, via the opening, with a chamber of the left side of the heart, and (ii) a greater blood pressure in the chamber of the left side of the heart relative to a blood pressure in a corresponding chamber of the right side of the heart increases a volume of the interior that is disposed within the corresponding chamber of the right side of the heart.

72. The method according to claim 71, wherein the cell includes an elastic membrane, and implanting the cell comprises implanting the cell that includes the elastic membrane, such that the elastic membrane elastically expands into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

73. The method according to claim 71, wherein the cell is a balloon, and implanting the cell comprises implanting the balloon, such that the balloon expands into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

74. The method according to claim 71, wherein implanting the cell comprises implanting a cell that is slidably mounted in a mount, such that the mount is fixed at the transseptal fenestration, and the cell slides into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

75. The method according to claim 71, wherein implanting the cell comprises implanting the cell such that the volume of the interior that is disposed within the corresponding chamber of the right side of the heart increases only when the blood pressure in the chamber of the left side of the heart is greater than the blood pressure in the chamber of the right side of the heart by more than a threshold difference of 4-6 mmHg.

76. A method for use with a heart of a subject, the method comprising:

making a transapical puncture into a left ventricle of the heart;

making a transseptal fenestration in the heart;

advancing a distal end of a tube through the transapical puncture;

delivering a prosthetic valve via the tube disposed through the transapical puncture and implanting the prosthetic valve at a mitral valve of the heart; and

subsequently to delivering the prosthetic valve and making the transseptal fenestration, closing the transapical puncture.

77. The method according to claim 76, wherein the subject has not been identified as suffering from heart failure, and wherein performing the method comprises performing the method on the subject that has not been identified as suffering from heart failure.

78. The method according to claim 76, wherein making the transseptal fenestration comprises making the transseptal fenestration via the transapical puncture.

79. The method according to claim 76, wherein making the transseptal fenestration comprises making the transseptal fenestration via a transfemoral route.

80. The method according to claim 76, wherein making the transseptal fenestration comprises making a fenestration in the interventricular septum.

81. The method according to claim 76, wherein making the transseptal fenestration comprises making a fenestration in the interatrial septum.

82. The method according to claim 76, wherein making the transseptal fenestration comprises making the transseptal fenestration after implanting the prosthetic valve.

83. The method according to claim 76, wherein making the transseptal fenestration comprises making the transseptal fenestration before implanting the prosthetic valve.

84. The method according to claim 76, wherein making the transseptal fenestration comprises making the transseptal fenestration via the tube.

85. The method according to claim 76, further comprising implanting a shunt device into the transseptal fenestration.

86. The method according to claim 85, wherein the shunt device includes a check valve, and implanting the shunt device comprises implanting the shunt device such that the check valve facilitates one-way blood flow from a chamber of the left side of the heart, via the transseptal fenestration, to a chamber of the right side of the heart.

87. The method according to claim 85, wherein implanting the shunt device comprises implanting a shunt device that is shaped to define a lumen, and includes a membrane that regulates blood flow through the lumen.

88. The method according to claim 87, wherein implanting the shunt device comprises implanting a shunt device that includes a membrane that (a) has (i) a closed position in which the membrane inhibits blood flow through the lumen, and (ii) an open position in which the inhibiting of the blood flow is reduced, resides in the closed position while a blood pressure difference across the membrane is lower than a threshold blood pressure difference of 4-6 mmHg (e.g., 5 mmHg), and moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference.

89. The method according to claim 88, wherein the membrane moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane, and implanting the shunt device that includes the membrane comprises implanting the shunt device that includes the membrane that moves from the closed position into the open position in response to the blood pressure difference exceeding the threshold blood pressure difference in either direction across the membrane.

91. The method according to claim 76, further comprising implanting at the transseptal fenestration, a balloon device that includes a balloon having an interior and an opening into the interior, such that (i) the interior is in fluid communication, via the opening, with a chamber of the left side of the heart, and (ii) a greater blood pressure in the chamber of the left side of the heart relative to a blood pressure in a corresponding chamber of the right side of the heart inflates the balloon such that the balloon reversibly expands into the corresponding chamber of the right side of the heart.

92. The method according to claim 91, wherein the balloon is elastic, and implanting the balloon device comprises implanting the balloon device such that the balloon automatically deflates in response to a reduction in the greater blood pressure in the chamber of the left side of the heart.

93. The method according to claim 91, wherein implanting the balloon device comprises implanting the balloon such that the balloon inflates only when blood pressure in the chamber of the left side of the heart is more than 4-6 mmHg greater than blood pressure in the chamber of the right side of the heart.

94. The method according to claim 91, wherein implanting the balloon device comprises sealing the transseptal fenestration with the balloon device.

95. The method according to claim 76, further comprising implanting at the transseptal fenestration, an elastic membrane that elastically expands in response to a difference in blood pressure across the membrane.

96. The method according to claim 95, wherein implanting the elastic membrane comprises sealing the transseptal fenestration with the elastic membrane.

97. The method according to claim 76, further comprising implanting at the transseptal fenestration, a cell having an interior and an opening into the interior, such that (i) the interior is in fluid communication, via the opening, with a chamber of the left side of the heart, and (ii) a greater blood pressure in the chamber of the left side of the heart relative to a blood pressure in a corresponding chamber of the right side of the heart increases a volume of the interior that is disposed within the corresponding chamber of the right side of the heart.

98. The method according to claim 97, wherein the cell includes an elastic membrane, and implanting the cell comprises implanting the cell that includes the elastic membrane, such that the elastic membrane elastically expands into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

99. The method according to claim 97, wherein the cell is a balloon, and implanting the cell comprises implanting the balloon, such that the balloon expands into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

100. The method according to claim 97, wherein implanting the cell comprises implanting a cell that is slidably mounted in a mount, such that the mount is fixed at the transseptal fenestration, and the cell slides into the chamber of the right side of the heart in response to the greater blood pressure in the chamber of the left side of the heart.

101. The method according to claim 97, wherein implanting the cell comprises implanting the cell such that the volume of the interior that is disposed within the corresponding chamber of the right side of the heart increases only when the blood pressure in the chamber of the left side of the heart is greater than the blood pressure in the chamber of the right side of the heart by more than a threshold difference of 4-6 mmHg.