Blood flow conduit delivery system and method of use

• US 6,302,892 B1
• Filed: 08/04/1999
• Issued: 10/16/2001
• Est. Priority Date: 08/04/1999
• Status: Expired due to Fees

• Current Assignee: Horizon Technology Funding Co. LLC (Horizon Technology Finance Management LLC)
• Original Assignee: Percardia, Inc.
• Inventors: Wilk, Peter J.
• Primary Examiner(s): Smith, Jeffrey A.
• Assistant Examiner(s): Robert, Eduardo C.
• Application Number:
  US09/368,644
• Time in Patent Office: 804 Days
• Field of Search: 606/108, 606/194, 606/195, 606/198, 623/1.11, 128/898, 604/96.01, 604/164.01, 604/528
• US Class Current: 606/108
• 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: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices

Abstract

Described herein is a catheter system for delivering an L-shaped conduit into the body of a patient between the left ventricle and coronary artery. A shunt preferably made of semirigid material is inserted into the lumen of a delivery catheter. The delivery catheter is advanced within the patient until its distal end is located adjacent to the desired insertion site, which is preferably the junction between a coronary artery and passageway formed in the myocardium between the left ventricle and coronary artery. A proximal section of the shunt is first advanced out of the delivery catheter into the myocardial passageway. A distal section of the shunt is advanced into the coronary artery, preferably by advancing the distal section of the shunt into the myocardial passageway and then pulling the distal section back into the coronary artery, or by pushing the distal section of the shunt in a folded configuration out of the delivery catheter into the coronary artery. In one embodiment, the shunt is made of a collapsible material for insertion into the delivery catheter, the shunt expanding upon removal from the delivery catheter.

Claims

1. A method of delivering a conduit into a portion of a patient'"'"'s body having a first passageway and a second passageway joined generally at an angle, comprising:

providing a delivery catheter having a proximal end and a distal end and a lumen extending therethrough;

placing the delivery catheter in the patient such that the proximal end extends outside of the patient and the distal end is located substantially adjacent a location where the first passageway and the second passageway are joined;

providing a conduit in the lumen of the delivery catheter, the conduit having a proximal section and a distal section;

advancing the proximal section of the conduit out of the lumen at the distal end of the delivery catheter into the first passageway; and

advancing the distal section of the conduit into the second passageway,

wherein the first passageway is a myocardial passageway formed through the myocardium of the heart between the left ventricle and a coronary artery.

2. The method of claim 1, wherein the second passageway is in a portion of the coronary artery downstream from the myocardial passageway.

3. The method of claim 2, wherein the conduit is provided in the lumen at the distal end of the delivery catheter in a substantially linear configuration, the conduit while provided in the lumen having a proximal end located nearer to the distal end of the delivery catheter and a distal end located nearer to the proximal end of the delivery catheter.

4. The method of claim 3, further comprising, after advancing the proximal section of the conduit out of the lumen into the myocardial passageway, advancing the distal section of the conduit into the myocardial passageway such that the conduit is substantially completely outside of the lumen of the delivery catheter and the proximal end of the conduit extends into the left ventricle.

5. The method of claim 4, wherein advancing the distal section of the conduit into the second passageway comprises moving the distal section out of the myocardial passageway and into the coronary artery.

6. The method of claim 2, wherein the conduit is provided in the lumen at the distal end in a folded configuration, wherein the distal section of the conduit is folded over the proximal section, the conduit having a proximal end and a distal end that both face the distal end of the delivery catheter, the proximal end of the conduit being located closer to the distal end of the delivery catheter than the distal end of the conduit is located to the distal end of the delivery catheter.

7. The method of claim 6, wherein the proximal section of the conduit is advanced into the first passageway by pushing the conduit out of the lumen.

8. The method of claim 7, wherein the distal section of the conduit is advanced into the second passageway by pushing the conduit out of the lumen.

9. The method of claim 1, further comprising collapsing the conduit prior to providing the conduit in the lumen.

10. The method of claim 1, wherein, prior to advancing the proximal section out of the delivery catheter, the delivery catheter is placed such that the lumen at the distal end faces at least partially into the first passageway.

11. The method of claim 1, further comprising forming the first passageway.

12. The method of claim 11, wherein forming the passageway includes inserting a dilation mechanism into the myocardial wall and dilating the myocardial wall.

13. The method of claim 12, wherein the dilation mechanism is a balloon and dilating the myocardial wall includes inflating the balloon.

14. The method of claim 1, further comprising, prior to advancing the conduit into the first passageway, releasably attaching a rod to the conduit.

15. The method of claim 14, wherein advancing the conduit into the first passageway comprises pushing the rod distally to move the conduit out of the lumen.

16. The method of claim 14, wherein advancing the conduit out of the distal end of the lumen and into the second passageway comprises pushing the rod into the second passageway.

17. The method of claim 1, further comprising positioning the delivery catheter such that the distal end of the lumen faces at least partially toward the first passageway while advancing the proximal section of the conduit into the first passageway.

18. The method of claim 1, further comprising positioning the delivery catheter such that the distal end of the lumen substantially faces downstream in the coronary artery while advancing the distal section of the conduit into the second passageway.

19. The method of claim 1, wherein the conduit is made of a shape memory material having a collapsible shape when provided in the delivery catheter and an expanded shape when advanced into the first passageway and into the second passageway.

20. The method of claim 1, wherein placing the delivery catheter includes advancing the delivery catheter through a blood vessel.

21. A method of delivering a conduit into a portion of a patient'"'"'s body having a first passageway and a second passageway joined generally at an angle, comprising:

forming the first passageway;

providing a delivery catheter having a proximal end and a distal end and a lumen extending therethrough;

placing the delivery catheter in the patient such that the proximal end extends outside of the patient and the distal end is located substantially adjacent a location where the first passageway and the second passageway are joined;

providing a conduit in the lumen of the delivery catheter, the conduit having a proximal section and a distal section;

advancing the proximal section of the conduit out of the lumen at the distal end of the delivery catheter into the first passageway; and

advancing the distal section of the conduit into the second passageway,

wherein the first passageway is formed in a myocardial wall of a heart between a heart chamber and a blood vessel, and the second passageway is in the blood vessel.

22. The method of claim 21, wherein the dilation mechanism is a balloon and dilating the myocardial wall includes inflating the balloon.

23. The method of claim 22, wherein the dilation mechanism is a balloon and dilating the myocardial wall includes inflating the balloon.

24. The method of claim 21, wherein the second passageway is in a portion of the blood vessel downstream from the myocardial passageway.

25. The method of claim 24, wherein the conduit is provided in the lumen at the distal end of the delivery catheter in a substantially linear configuration, the conduit while provided in the lumen having a proximal end located nearer to the distal end of the delivery catheter and a distal end located nearer to the proximal end of the delivery catheter.

26. The method of claim 25, further comprising, after advancing the proximal section of the conduit out of the lumen into the myocardial passageway, advancing the distal section of the conduit into the myocardial passageway such that the conduit is substantially completely outside of the lumen of the delivery catheter and the proximal end of the conduit extends into the heart chamber.

27. The method of claim 26, wherein advancing the distal section of the conduit into the second passageway comprises moving the distal section out of the myocardial passageway and into the blood vessel.

28. The method of claim 24, wherein the conduit is provided in the lumen at the distal end in a folded configuration, wherein the distal section of the conduit is folded over the proximal section, the conduit having a proximal end and a distal end that both face the distal end of the delivery catheter, the proximal end of the conduit being located closer to the distal end of the delivery catheter than the distal end of the conduit is located to the distal end of the delivery catheter.

29. The method of claim 28, wherein the proximal section of the conduit is advanced into the first passageway by pushing the conduit out of the lumen.

30. The method of claim 26, wherein the distal section of the conduit is advanced into the second passageway by pushing the conduit out of the lumen.

31. The method of claim 21, wherein, prior to advancing the proximal section out of the delivery catheter, the delivery catheter is placed such that the lumen at the distal end faces at least partially into the first passageway.

32. The method of claim 21, wherein placing the delivery catheter includes advancing the delivery catheter through a blood vessel.

33. A method of delivering a conduit into a portion of a patient'"'"'s body having a first passageway and a second passageway joined generally at an angle, comprising:

providing a delivery catheter having a proximal end and a distal end and a lumen extending therethrough;

placing the delivery catheter in the patient such that the proximal end extends outside of the patient and the distal end is located substantially adjacent a location where the first passageway and the second passageway are joined;

providing a conduit in the lumen of the delivery catheter, the conduit having a proximal section and a distal section;

advancing the proximal section of the conduit out of the lumen at the distal end of the delivery catheter into the first passageway; and

advancing the distal section of the conduit into the second passageway,

wherein delivering the conduit includes creating a bypass between a chamber of a heart and a blood vessel adjacent to the chamber.

34. The method of claim 33, wherein the first passageway is a myocardial passageway formed through the myocardium of the heart between a left ventricle and a coronary artery.

35. The method of claim 34, wherein the second passageway is in a portion of the coronary artery downstream from the myocardial passageway.

36. The method of claim 35, wherein the conduit is provided in the lumen at the distal end of the delivery catheter in a substantially linear configuration, the conduit while provided in the lumen having a proximal end located nearer to the distal end of the delivery catheter and a distal end located nearer to the proximal end of the delivery catheter.

37. The method of claim 36, further comprising, after advancing the proximal section of the conduit out of the lumen into the myocardial passageway, advancing the distal section of the conduit into the myocardial passageway such that the conduit is substantially completely outside of the lumen of the delivery catheter and the proximal end of the conduit extends into the left ventricle.

38. The method of claim 37, wherein advancing the distal section of the conduit into the second passageway comprises moving the distal section out of the myocardial passageway and into the coronary artery.

39. The method of claim 35, wherein the conduit is provided in the lumen at the distal end in a folded configuration, wherein the distal section of the conduit is folded over the proximal section, the conduit having a proximal end and a distal end that both face the distal end of the delivery catheter, the proximal end of the conduit being located closer to the distal end of the delivery catheter than the distal end of the conduit is located to the distal end of the delivery catheter.

40. The method of claim 39, wherein the proximal section of the conduit is advanced into the first passageway by pushing the conduit out of the lumen.

41. The method of claim 40, wherein the distal section of the conduit is advanced into the second passageway by pushing the conduit out of the lumen.

42. The method of claim 33, wherein, prior to advancing the proximal section out of the delivery catheter, the delivery catheter is placed such that the lumen at the distal end faces at least partially into the first passageway.

43. The method of claim 33, wherein placing the delivery catheter includes advancing the delivery catheter through a blood vessel.

44. The method of claim 33, further comprising forming the first passageway.

45. The method of claim 44, wherein the heart chamber is a left ventricle and the blood vessel is a coronary artery, and the first passageway is formed in a myocardial wall of a heart between the left ventricle and the coronary artery, and the second passageway is in the coronary artery.

46. A method of delivering a conduit into a portion of a patient'"'"'s body having a first passageway and a second passageway joined generally at an angle, comprising:

providing a delivery catheter having a proximal end and a distal end and a lumen extending therethrough;

placing the delivery catheter in the patient such that the proximal end extends outside of the patient and the distal end is located substantially adjacent a location where the first passageway and the second passageway are joined;

providing a conduit in the lumen of the delivery catheter, the conduit having a proximal section and a distal section;

releasably attaching a rod to the conduit;

advancing the proximal section of the conduit out of the lumen at the distal end of the delivery catheter into the first passageway; and

advancing the distal section of the conduit into the second passageway by pushing the rod into the second passageway.

47. The method of claim 46, wherein the first passageway is a myocardial passageway formed through the myocardium of the heart between the left ventricle and a coronary artery.

48. The method of claim 47, wherein the second passageway is in a portion of the coronary artery downstream from the myocardial passageway.

49. The method of claim 48, wherein the conduit is provided in the lumen at the distal end of the delivery catheter in a substantially linear configuration, the conduit while provided in the lumen having a proximal end located nearer to the distal end of the delivery catheter and a distal end located nearer to the proximal end of the delivery catheter.

50. The method of claim 49, further comprising, after advancing the proximal section of the conduit out of the lumen into the myocardial passageway, advancing the distal section of the conduit into the myocardial passageway such that the conduit is substantially completely outside of the lumen of the delivery catheter and the proximal end of the conduit extends into the left ventricle.

51. The method of claim 50, wherein advancing the distal section of the conduit into the second passageway comprises moving the distal section out of the myocardial passageway and into the coronary artery.

52. The method of claim 48, wherein the conduit is provided in the lumen at the distal end in a folded configuration, wherein the distal section of the conduit is folded over the proximal section, the conduit having a proximal end and a distal end that both face the distal end of the delivery catheter, the proximal end of the conduit being located closer to the distal end of the delivery catheter than the distal end of the conduit is located to the distal end of the delivery catheter.

53. The method of claim 52, wherein the proximal section of the conduit is advanced into the first passageway by pushing the conduit with the rod out of the lumen.

54. The method of claim 46, wherein, prior to advancing the proximal section out of the delivery catheter, the delivery catheter is placed such that the lumen at the distal end faces at least partially into the first passageway.

55. The method of claim 46, wherein placing the delivery catheter includes advancing the delivery catheter through a blood vessel.

56. The method of claim 46, further comprising forming the first passageway.

57. The method of claim 56, wherein the first passageway is formed in a myocardial wall of a heart between a heart chamber and a blood vessel, and the second passageway is in the blood vessel.