TRANSAPICAL DELIVERY SYSTEM WITH VENTRUCULO-ARTERIAL OVERLFOW BYPASS

• US 20110112631A1
• Filed: 10/16/2007
• Published: 05/12/2011
• Est. Priority Date: 10/16/2006
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Corevalve LLC (Medtronic Plc)
• Inventors: Tuval, Yosi, Benary, Raphael
• Granted Patent: US 8,784,478 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067

Abstract

Apparatus is provided for implanting a prosthetic device (108) in a patient, the apparatus includes a trocar tube (101), a first portion of which is configured to be placed in a left ventricle (12) of the patient during a procedure for implantation of the prosthetic device (108), and a second portion of which is configured to be placed in an extracardiac location during the procedure. The first portion is shaped so as to define at least one opening to an interior thereof. One or more flexible bypass tubes (103, 104, 106), each of which is coupled to the second portion, and each of which is configured to be coupled to at least one artery (20, 21, 30) of the patient, so as to create a blood flow bypass path during the procedure, from the left ventricle (12), via the opening and the bypass tubes (103, 105, 106), to the at least one artery (20, 21, 30). Other embodiments are also described.

Claims

1. Apparatus for implanting a prosthetic device in a patient, the apparatus comprising:

a trocar tube,

a first portion of which is configured to be placed in a left ventricle of the patient during a procedure for implantation of the prosthetic device, and

a second portion of which is configured to be placed in an extracardiac location during the procedure, the first portion being shaped so as to define at least one opening to an interior thereof; and

one or more flexible bypass tubes, each of which is coupled to the second portion, and each of which is configured to be coupled to at least one artery of the patient, so as to create a blood flow bypass path during the procedure, from the left ventricle, via the opening and the bypass tubes, to the at least one artery.

2. The apparatus according to claim 1, comprising one or more unidirectional valves configured to prevent backflow of blood into the left ventricle.

3. The apparatus according to claim 1, wherein a distal end of the first portion is shaped so as to define the at least one opening therethrough to the interior of the first portion, and wherein the trocar tube is configured to enable introduction of the prosthetic device via the at least one opening.

4. The apparatus according to claim 1, wherein the apparatus is configured to allow for passive blood flow through the at least one opening of the trocar tube in response to force generated by the left ventricle.

5. The apparatus according to claim 1, further comprising an external source of power, wherein the source of power is configured to facilitate active blood flow through the at least one opening of the trocar tube.

6. The apparatus according to claim 1, wherein the trocar tube is configured for transmyocardial delivery through a free wall of a heart of the patient.

7. The apparatus according to claim 1, wherein the trocar tube is configured for transapical delivery through an apex of a heart of the patient, into the left ventricle of the patient.

8. The apparatus according to claim 1, wherein the valve includes an aortic valve, and wherein the one or more bypass tubes are configured to create a blood flow bypass to a descending aorta of the patient.

9. The apparatus according to claim 1, wherein the valve includes an aortic valve, and wherein the one or more bypass tubes are configured to create a blood flow bypass to a femoral artery of the patient.

10. The apparatus according to claim 1, wherein the valve includes an aortic valve, and wherein the one or more bypass tubes are configured to create a blood flow bypass to an iliac artery of the patient.

11. The apparatus according to any one of claims 1-10, wherein the first portion is shaped to define a wall, the wall being shaped so as to define the at least one opening to the interior of the first portion.

12. The apparatus according to claim 11, wherein the wall of the first portion is shaped to provide a plurality of openings.

13. The apparatus according to any one of claims 1-10, wherein the first portion of the trocar tube is configured to house therein the prosthetic device in a compressed state thereof.

14. The apparatus according to claim 13, wherein the prosthetic device is configured to be pushed through a valve of the patient from within the first portion.

15. The apparatus according to claim 14, wherein the prosthetic device is configured to expand from the compressed state once the prosthetic device is pushed through the valve.

16. The apparatus according to claim 13, wherein a portion of the first portion is configured to be advanced through a valve of the subject, and wherein the prosthetic device is configured to be pushed from within the first portion once the first portion is advanced through the valve.

17. The apparatus according to claim 16, wherein the prosthetic device is configured to expand from the compressed state once the prosthetic device is pushed from within the first portion of the tube.

18. The apparatus according to any one of claims 1-10, wherein the prosthetic device comprises a prosthetic valve.

19. The apparatus according to claim 18, wherein the prosthetic valve is configured to be advanced through a native valve of the patient.

20. The apparatus according to claim 19, wherein the one or more bypass tubes are configured to create the blood flow bypass path during advancement of the prosthetic valve through the native valve of the patient.

21. A method for implanting a prosthetic device in a patient, the method comprising:

transmyocardially advancing a trocar tube housing a prosthesis into a left ventricle of a subject;

advancing the prosthesis through a valve of the patient; and

during the advancing of the prosthesis, providing a blood flow bypass path from the left ventricle of the patient, through at least a portion of the trocar tube, and to an extracardiac arterial site downstream from the valve.

22. The method according to claim 21, wherein transmyocardially advancing the trocar tube comprises transmyocardially advancing the trocar tube through a free wall of the heat.

23. The method according to claim 21, wherein transmyocardially advancing the trocar tube comprises transapically advancing the tube into the left ventricle of the patient.

24. The method according to claim 21, wherein advancing the prosthesis comprises pushing a distal end of the trocar tube through the valve of the patient.

25. The method according to claim 21, further comprising allowing the prosthesis to expand following the advancing of the prosthesis through the valve.

26. The method according to claim 21, wherein the valve includes an aortic valve, wherein advancing the prosthesis through the valve comprises advancing the prosthesis through the aortic valve, and wherein providing the blood flow bypass path comprises providing the blood flow bypass path from the left ventricle to a descending aorta of the patient.

27. The method according to claim 21, wherein the valve includes an aortic valve, wherein advancing the prosthesis through the valve comprises advancing the prosthesis through the aortic valve, and wherein providing the blood flow bypass path comprises providing the blood flow bypass path from the left ventricle to a femoral artery of the patient.

28. The method according to claim 21, wherein the valve includes an aortic valve, wherein advancing the prosthesis through the valve comprises advancing the prosthesis through the aortic valve, and wherein providing the blood flow bypass path comprises providing the blood flow bypass path from the left ventricle to an iliac artery of the patient.

29. The method according to any one of claims 21-28, further comprising restricting blood flow through the valve during the advancing of the prosthesis therethrough.

30. The method according to claim 29, wherein providing a blood flow bypass path comprises draining blood from the left ventricle to the extracardiac site in response to the restricting.

31. The method according to claim 30, wherein draining the blood comprises actively draining the blood.

32. The method according to claim 30, wherein restricting the blood flow comprises increasing a contractile force of the left ventricle, and wherein draining the blood comprises allowing the blood to be passively drained through the trocar tube in response to the increasing.

33. Apparatus for implanting a prosthetic device in a patient, the apparatus comprising:

a trocar tube,

a first portion of which is configured to be placed in a right ventricle of the patient during a procedure for implantation of the prosthetic device, and

a second portion of which is configured to be placed in an extracardiac location during the procedure, the first portion being shaped so as to define at least one opening to an interior thereof; and

one or more flexible bypass tubes, each of which is coupled to the second portion, and each of which is configured to be coupled to at least one artery of the patient, so as to create a blood flow bypass path during the procedure, from the right ventricle, via the opening and the bypass tubes, to the at least one artery.

34. The apparatus according to claim 33, comprising one or more unidirectional valves configured to prevent backflow of blood into the right ventricle.

35. The apparatus according to claim 33, wherein a distal end of the first portion is shaped so as to define the at least one opening therethrough to the interior of the first portion, and wherein the trocar tube is configured to enable introduction of the prosthetic device via the at least one opening.

36. The apparatus according to claim 33, wherein the apparatus is configured to allow for passive blood flow through the at least one opening of the trocar tube in response to force generated by the right ventricle.

37. The apparatus according to claim 33, further comprising an external source of power, wherein the source of power is configured to facilitate active blood flow through the at least one opening of the trocar tube.

38. The apparatus according to claim 33, wherein the trocar tube is configured for transmyocardial delivery through a free wall of a heart of the patient.

39. The apparatus according to claim 33, wherein the trocar tube is configured for transapical delivery through a right ventricular apex of a heart of the patient, into the right ventricle of the patient.

40. The apparatus according to claim 33, wherein the valve includes a pulmonary valve, and wherein the one or more bypass tubes are configured to create a blood flow bypass to a pulmonary artery of the patient.

41. The apparatus according to any one of claims 33-40, wherein the first portion is shaped to define a wall, the wall being shaped so as to define the at least one opening to the interior of the first portion.

42. The apparatus according to claim 41, wherein the wall of the first portion is shaped to provide a plurality of openings.

43. The apparatus according to any one of claims 33-40, wherein the first portion of the trocar tube is configured to house therein the prosthetic device in a compressed state thereof.

44. The apparatus according to claim 43, wherein the prosthetic device is configured to be pushed through a valve of the patient from within the first portion.

45. The apparatus according to claim 44, wherein the prosthetic device is configured to expand from the compressed state once the prosthetic device is pushed through the valve.

46. The apparatus according to claim 43, wherein a portion of the first portion is configured to be advanced through a valve of the subject, and wherein the prosthetic device is configured to be pushed from within the first portion once the first portion is advanced through the valve.

47. The apparatus according to claim 46, wherein the prosthetic device is configured to expand from the compressed state once the prosthetic device is pushed from within the first portion of the tube.

48. The apparatus according to any one of claims 33-40, wherein the prosthetic device comprises a prosthetic valve.

49. The apparatus according to claim 48, wherein the prosthetic valve is configured to be advanced through a native valve of the patient.

50. The apparatus according to claim 49, wherein the one or more bypass tubes are configured to create the blood flow bypass path during advancement of the prosthetic valve through the native valve of the patient.

51. A method for implanting a prosthetic device in a patient, the method comprising:

transmyocardially advancing a trocar tube housing a prosthesis into a right ventricle of a patient;

advancing the prosthesis through a valve of the patient; and

during the advancing of the prosthesis, providing a blood flow bypass path from the right ventricle of the patient, through at least a portion of the trocar tube, and to an extracardiac arterial site downstream from the valve.

52. The method according to claim 51, wherein transmyocardially advancing the trocar tube comprises transmyocardially advancing the trocar tube through a free wall of the heat.

53. The method according to claim 51, wherein transmyocardially advancing the trocar tube comprises transapically advancing the tube through a right ventricular apex and into the right ventricle of the patient.

54. The method according to claim 51, wherein advancing the prosthesis comprises pushing a distal end of the trocar tube through the valve of the patient.

55. The method according to claim 51, further comprising allowing the prosthesis to expand following the advancing of the prosthesis through the valve.

56. The method according to claim 51, wherein the valve includes a pulmonary valve, wherein advancing the prosthesis through the valve comprises advancing the prosthesis through the pulmonary valve, and wherein providing the blood flow bypass path comprises providing the blood flow bypass path from the right ventricle to a pulmonary artery of the patient.

57. The method according to any one of claims 51-56, further comprising restricting blood flow through the valve during the advancing of the prosthesis therethrough.

58. The method according to claim 57, wherein providing a blood flow bypass path comprises draining blood from the right ventricle to the extracardiac site in response to the restricting.

59. The method according to claim 58, wherein draining the blood comprises actively draining the blood.

60. The method according to claim 58, wherein restricting the blood flow comprises increasing a contractile force of the right ventricle, and wherein draining the blood comprises allowing the blood to be passively drained through the trocar tube in response to the increasing.