SYSTEMS AND METHODS FOR TRANSCATHETER AORTIC VALVE TREATMENT

• US 20110213459A1
• Filed: 02/24/2011
• Published: 09/01/2011
• Est. Priority Date: 02/26/2010
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Garrison, Michi E., Hyde, Gregory M., Chou, Tony M.
• Granted Patent: US 8,545,552 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• 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 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0067 conical

Abstract

Devices and methods are configured to allow transcervical or subclavian access via the common carotid artery to the native aortic valve, and implantation of a prosthetic aortic valve into the heart. The devices and methods also provide means for embolic protection during such an endovascular aortic valve implantation procedure.

Claims

1. A system for aortic valve treatment, comprising:

an arterial access sheath adapted to be introduced into an access site at the left common carotid artery, right common carotid artery, left subclavian artery, or right subclavian artery, wherein the arterial access sheath includes an internal lumen sized and shaped to receive a valve delivery system configured to deliver a prosthetic valve into the heart through the arterial access sheath;

an occlusion element on the arterial access sheath, the occlusion element adapted to occlude an artery.

2. A system as in claim 1, further comprising a valve delivery system configured to deliver a prosthetic valve into the heart through the arterial access sheath.

3. A system as in claim 1, wherein the occlusion element is a balloon.

4. A system as in claim 1, wherein the sheath has an aspiration port.

5. A system as in claim 1, further comprising a collection reservoir fluidly coupled to the access sheath and adapted to receive fluid from the sheath.

6. A system as in claim 1, further comprising a venous return shunt fluidly coupled to the access sheath and adapted to receive fluid from the sheath for passing to a vein.

7. A system as in claim 4, further comprising an aspiration source coupled to the aspiration port.

8. A system as in claim 1, further comprising a filter coupled to the arterial access sheath to provide embolic protection.

9. A system as in claim 8, wherein the filter is sized and shaped to be deployed across the ostium of the artery.

10. A system as in claim 8, wherein the filter is sized and shaped to be deployed across at least one of the innominate artery, left common carotid artery, or left subclavian artery.

11. A system as in claim 8, wherein the filter is configured to be deployed across the aorta.

12. A system as in claim 8, wherein the filter is integral with the sheath.

13. A system as in claim 8, wherein the filter is removably attached to the sheath.

14. A system as in claim 2, wherein the valve delivery system includes an elongated catheter.

15. A system as in claim 14, wherein the catheter has a length of 60, 70, or 80 cm.

16. A system for aortic valve treatment, comprising:

an arterial access sheath adapted to be introduced into an access site at the left common carotid artery, right common carotid artery, left subclavian artery, or right subclavian artery, wherein the arterial access sheath has an internal lumen sized and shaped to receive a valve delivery system configured to deliver a prosthetic valve into the heart through the arterial access sheath;

a filter coupled to the arterial access sheath to provide embolic protection.

17. A system as in claim 16, further comprising a valve delivery system configured to deliver a prosthetic valve into the heart through the arterial access sheath.

18. A system as in claim 16, further comprising an occlusion element on the arterial access sheath, the occlusion element adapted to occlude an artery.

19. A system as in claim 18, wherein the occlusion element is a balloon.

20. A system as in claim 16, wherein the sheath has an aspiration port.

21. A system as in claim 16, further comprising a collection reservoir fluidly coupled to the access sheath and adapted to receive fluid from the sheath.

22. A system as in claim 16, further comprising a venous return shunt fluidly coupled to the access sheath and adapted to receive fluid from the sheath for passing to a vein.

23. A system as in claim 20, further comprising an aspiration source coupled to the aspiration port.

24. A system as in claim 16, wherein the filter is configured to be deployed across the ostium of the artery.

25. A system as in claim 16, wherein the filter is configured to be deployed across at least one of the innominate artery, left common carotid artery, or left subclavian artery.

26. A system as in claim 16, wherein the filter is configured to be deployed across the aorta.

27. A system as in claim 16, wherein the filter is integral with the sheath.

28. A system as in claim 16, wherein the filter is removably attached to the sheath.

29. A system as in claim 17, wherein the valve delivery system includes an elongated catheter.

30. A system as in claim 29, wherein the catheter has a length of 60, 70, or 80 cm.

31. A system for transcervical aortic valve treatment, comprising:

an arterial access sheath adapted to be introduced into an access site at the left common carotid artery, right common carotid artery, left subclavian artery, or right subclavian artery, wherein the arterial access sheath has an internal lumen sized and shaped to receive a valve delivery system adapted to deliver a prosthetic valve into the heart through the arterial access sheath;

a return shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access sheath to a return site.

32. A system as in claim 31, further comprising a valve delivery system adapted to delivery a prosthetic valve into the heart through the arterial access sheath.

33. A system as in claim 31, further comprising an occlusion element on the arterial access sheath, the occlusion element adapted to occlude an artery.

34. A system as in claim 33, wherein the occlusion element is a balloon.

35. A system as in claim 31, wherein the sheath has an aspiration port.

36. A system as in claim 31, further comprising a collection reservoir fluidly coupled to the access sheath via the shunt and adapted to receive fluid from the sheath.

37. A system as in claim 31, further comprising a venous return shunt fluidly coupled to the access sheath and adapted to receive fluid from the sheath for passing to a vein.

38. A system as in claim 35, further comprising an aspiration source coupled to the aspiration port.

39. A system as in claim 31, further comprising a filter coupled to the arterial access sheath to provide embolic protection

40. A system as in claim 39, wherein the filter is configured to be deployed across the ostium of the artery.

41. A system as in claim 39, wherein the filter is configured to be deployed across at least one of the innominate artery, left common carotid artery, or left subclavian artery.

42. A system as in claim 39, wherein the filter is configured to be deployed across the aorta.

43. A system as in claim 39, wherein the filter is integral with the sheath.

44. A system as in claim 39, wherein the filter is removably attached to the sheath.

45. A system as in claim 32, wherein the valve delivery system includes an elongated catheter.

46. A system as in claim 45, wherein the catheter has a length of 60, 70, or 80 cm.

47. A system for aortic valve treatment, comprising:

an arterial access sheath adapted to be introduced into an access site at the left or right common carotid artery, or left or right subclavian artery, wherein the arterial access sheath has a first lumen sized and shaped to receive a valve delivery system configured to deliver a prosthetic valve into the heart through the arterial access sheath;

a Y-arm disposed at a proximal region of the arterial access sheath; and

a flow shunt fluidly connected to the Y-arm, wherein the flow shunt is adapted to perfuse the distal carotid artery.

48. A system as in claim 47, further comprising:

a second lumen in the arterial access sheath, the second lumen having a proximal and a distal end, wherein the proximal end is connected to the flow shunt and the distal end has an opening which is positioned proximal to the distal end of the access sheath

49. A system as in claim 47, wherein the flow shunt is connected to a second catheter adapted to be inserted in the carotid artery distal to the access site of the arterial access sheath

50. A system as in claim 47, further comprising:

an active pump which will pump blood through the flow shunt

51. A system for aortic valve treatment, comprising:

an arterial access sheath adapted to be introduced into an access site at the left or right common carotid artery, or left or right subclavian artery, wherein the arterial access sheath has an internal lumen sized and shaped to receive a valve delivery system configured to deliver a prosthetic valve into the heart through the arterial access sheath;

a side opening in the arterial access sheath adapted to allow blood flow antegrade into the tip of the access sheath and out the side opening to perfuse the distal carotid artery; and

a dilator which is inside the access sheath during insertion of the access sheath into the artery and which prevents flow through the sheath and out the side opening during access sheath insertion.

52. A system as in claim 51, further comprising a filter over the side opening which bulges outward so as not to be disrupted during insertion of the prosthetic valve through the sheath, wherein the filter is configured to entrap embolic debris from the blood which is flowing out the side opening of the sheath.

53. A system as in claim 51, further comprising a positioning feature which maintains the position of side opening with respect to the insertion site once the access sheath has been positioned in the artery

54. A method of treating an aortic valve, comprising:

forming a penetration at the neck of a patient in a wall of a common carotid artery;

introducing an access sheath through the penetration;

occluding the artery;

inserting a guide wire through the access sheath and across the native aortic valve;

introducing a prosthetic valve through the access sheath and percutaneously deploying the prosthetic valve at or near the position of the native aortic valve.

55. A method as in claim 54, further comprising:

removing the access sheath;

closing the penetration.

56. A method as in claim 54, further comprising applying a closure device at a site of the penetration before introducing the arterial access sheath through the penetration.

57. A method as in claim 56, wherein the closure device comprises a suture-based closure device.

58. A method as in claim 54, further comprising applying aspiration to the artery through the access sheath.

59. A method as in claim 54, further comprising establishing passive blood flow from the artery such that blood flows into a lumen of the arterial access sheath and into a shunt connected to the access sheath.

60. A method as in claim 59, further comprising fluidly connecting the shunt to a collection reservoir or a venous return site in the patient.

61. A method as in claim 59, further comprising regulating the rate of passive flow from the artery.

62. A method as in claim 58, further comprising regulating a rate of the aspiration.

63. A method as in claim 54, further comprising deploying a filter to provide embolic protection in an artery.

64. A method as in claim 62, wherein the filter is coupled to the arterial access sheath.

65. A method as in claim 62, wherein the filter is configured to be deployed across the ostium of the artery.

66. A method as in claim 62, wherein the filter is configured to be deployed across at least one of the innominate artery, left common carotid artery, or left subclavian artery.

67. A method as in claim 62, wherein the filter is configured to be deployed across the aorta.

68. A method as in claim 62, wherein the filter is integral with the sheath.

69. A method as in claim 62, wherein the filter is removably attached to the sheath.

70. A method as in claim 54, further comprising establishing retrograde blood flow through the artery such that blood flows into a lumen of the arterial access sheath and into a shunt connected to the access sheath.

71. A method as in claim 54, wherein occluding the artery comprises inflating an occlusion balloon.

72. A method of treating an aortic valve, comprising:

forming a penetration at the neck of a patient in a wall of a common carotid artery;

introducing an access sheath through the penetration;

deploying a filter to provide embolic protection in an artery;

inserting a guide wire through the access sheath and across the native aortic valve;

introducing a prosthetic valve through the access sheath and deploying the prosthetic valve at or near the position of the native aortic valve.

73. A method as in claim 72, further comprising:

removing the access sheath;

closing the penetration.

74. A method as in claim 72, further comprising applying a closure device at a site of the penetration before introducing the arterial access sheath through the penetration.

75. A method as in claim 74, wherein the closure device comprises a suture-based closure device.

76. A method as in claim 72, wherein the filter is coupled to the arterial access sheath.

77. A method as in claim 72, wherein the filter is configured to be deployed across the ostium of the artery.

78. A method as in claim 72, wherein the filter is configured to be deployed across at least one of the innominate artery, left common carotid artery, or left subclavian artery.

79. A method as in claim 72, wherein the filter is configured to be deployed across the aorta.

80. A method as in claim 72, wherein the filter is integral with the sheath.

81. A method as in claim 72, wherein the filter is removably attached to the sheath.

82. A method as in claim 72, further comprising occluding the artery.

83. A method as in claim 72, further comprising establishing passive blood flow from the artery such that blood flows into a lumen of the arterial access sheath and into a shunt connected to the access sheath

84. A method as in claim 83, further comprising fluidly connecting the shunt to a collection reservoir or a venous return site in the patient.

85. A method as in claim 83, further comprising regulating the rate of passive flow from the artery.

86. A method as in claim 82, further comprising applying aspiration to the artery through the access sheath.

87. A method as in claim 85, further comprising regulating a rate of the aspiration.

88. A method as in claim 82, wherein occluding the artery comprises inflating an occlusion balloon.