Left ventricular conduits and methods for delivery

• US 6,638,237 B1
• Filed: 08/01/2000
• Issued: 10/28/2003
• 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: Melsky, Gerald, Guiles, Marvin
• Primary Examiner(s): Jacyna, J. Casimer
• Application Number:
  US09/630,385
• Time in Patent Office: 1,183 Days
• Field of Search: 604/8, 604/9
• US Class Current: 604/8
• 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 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/94 Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

Conduits are provided to direct blood flow from the left ventricle to a coronary artery at a location distal to a blockage in the coronary artery. Threaded and nonthreaded conduits are delivered using a guidewire delivered through the posterior and anterior walls of a coronary artery and into the heart wall. A dilator may be provided over the guidewire into the heart wall, and the conduit delivered over the dilator. An introducer sleeve may be provided over the dilator into the heart wall, the dilator removed, and the conduit delivered through the introducer sleeve. A hollow needle also may be inserted into the posterior and anterior walls of the coronary artery prior to inserting the guidewire. A depth measuring tool may determine the appropriate length of the conduit prior to delivery. The depth measuring tool can include the hollow needle with an access port on a proximal end of the needle and an opening on the distal end of the needle in flow communication with the access port so that when the needle is inserted through the heart wall and into the heart chamber, blood flow through the opening.

Claims

1. A method of delivering a conduit into a heart wall between a heart chamber and an adjacent blood vessel, comprising:

inserting a hollow needle through an anterior wall and a posterior wall of the blood vessel through the heart wall and into the heart chamber;

inserting a guidewire through the hollow needle into the heart chamber;

removing the hollow needle;

inserting a dilator over the guidewire into the heart wall;

removing the guidewire; and

placing a conduit over the dilator into the heart wall.

2. The method of claim 1, further comprising measuring a thickness of the heart wall;

prior to placing the conduit.

3. The method of claim 1, further comprising determining if the needle has entered the heart chamber.

4. The method of claim 3, wherein the determining includes providing an access port near a proximal end of the needle and an opening in flow communication with the access port near a distal end of the needle such that blood enters the access port and exits the opening when the access port on the needle has been inserted into the heart chamber.

5. A method of delivering a conduit into a heart wall between a heart chamber and an adjacent blood vessel, comprising:

inserting a hollow needle through an anterior wall and a posterior wall of the blood vessel through the heart wall and into the heart chamber;

inserting a guidewire through the hollow needle into the heart chamber;

removing the hollow needle;

inserting a dilator over the guidewire into the heart wall;

removing the guidewire; and

placing a conduit over the dilator into the heart wall,

wherein placing the conduit includes screwing the conduit into the heart wall.

6. The method of claim 5, further comprising measuring a thickness of the heart wall prior to placing the conduit.

7. The method of claim 5, further comprising determining if the needle has entered the heart chamber.

8. The method of claim 7, wherein the determining includes providing an access port near a proximal end of the needle and an opening in flow communication with the access port near a distal end of the needle such that blood enters the access port and exits the opening when the access port on the needle has been inserted into the heart chamber.

9. A method of providing direct blood flow between a heart chamber and a coronary vessel, the method comprising:

placing a guide device through an anterior wall and a posterior wall of the coronary vessel and through a heart wall between the heart chamber and the coronary vessel;

forming a passageway in the heart wall at a location defined by the guide device;

placing a conduit within the passageway; and

delivering via the guide device a first mechanism for forming the passageway and a second mechanism for placing the conduit within the passageway.

10. The method of claim 9, wherein the first and second mechanisms are delivered via the guide device to the heart simultaneously.

11. The method of claim 9, wherein the first mechanism is delivered via the guide device to the heart and, after the first mechanism is removed from the heart via the guide device, the second mechanism is delivered via the guide device to the heart.

12. The method of claim 9, further comprising measuring a distance from the anterior wall of the coronary vessel to the heart chamber prior to placing the guide device.

13. The method of claim 9, wherein the guide device is a guidewire.

14. A method for inserting a conduit into a heart wall between a heart chamber and the coronary artery, comprising:

screwing a stylet having a threaded tip and a nonthreaded body portion into the heart wall;

screwing an outer sleeve having a threaded exterior over the nonthreaded body portion of the stylet;

removing the stylet; and

inserting the conduit into the heart wall through the outer sleeve.

15. A method for advancing a device into the heart wall of a patient through a coronary artery, comprising:

screwing a threaded device into the coronary artery to open the artery;

pulling back on the artery; and

screwing the threaded device into the heart wall.

16. A method of delivering a conduit into a heart wall between a heart chamber and an adjacent blood vessel, comprising:

inserting a hollow needle into the heart wall through the blood vessel into the heart chamber;

inserting a guidewire through the hollow needle into the heart chamber;

removing the hollow needle;

inserting a dilator over the guidewire into the heart wall;

removing the guidewire; and

screwing a threaded conduit over the dilator into the heart wall.

17. A method of providing direct blood flow between a heart chamber and a coronary vessel, the method comprising:

placing a guide device through an anterior wall and a posterior wall of the coronary vessel and through a heart wall between the heart chamber and the coronary vessel;

forming a passageway in the heart wall at a location defined by the guide device by inserting a dilator over the guide device at the location; and

placing a conduit within the passageway,

wherein the conduit is positioned over the dilator for placement within the passageway.

18. The method of claim 17, further comprising inserting a hollow needle through the anterior wall and posterior wall of the coronary vessel and the heart wall prior to placing the guide device.

19. The method of claim 18, wherein the guide device is a guidewire and placing the guide device includes inserting the guidewire through the hollow needle until an end of the guidewire rests in the heart chamber.

20. The method of claim 19, further comprising removing the hollow needle after inserting the guidewire through the hollow needle.

21. The method of claim 18, further comprising measuring a depth of insertion of the hollow needle.

22. The method of claim 21, wherein measuring the depth of insertion includes viewing a depth indication mechanism on the exterior of the needle.

23. The method of claim 22, wherein the depth indication mechanism includes at least one marking.

24. The method of claim 17, further comprising placing the guide device at an angle relative to the posterior wall of the coronary vessel.

25. The method of claim 24, wherein placing the guide device at the angle includes inserting a hollow needle at the angle through the anterior wall and the posterior wall of the coronary vessel and the heart wall prior to placing the guide device.

26. The method of claim 25, further comprising inserting the hollow needle through a guide template when inserting the hollow needle at the angle.

27. The method of claim 17, wherein the dilator is configured as a sleeve.

28. The method of claim 27, further comprising inserting a sheath over the dilator.

29. The method of claim 28, wherein placing the conduit includes inserting the conduit into the sheath.

30. The method of claim 17, further comprising inserting a sheath in the passageway.

31. The method of claim 30, wherein placing the conduit includes inserting the conduit into the sheath.

32. The method of claim 17, further comprising measuring a distance from the anterior wall of the coronary vessel to the heart chamber prior to placing the guide device.

33. The method of claim 17, wherein the guide device is a guidewire.

34. The method of claim 17, wherein the dilator includes a bleed hole.

35. The method of claim 17, wherein the dilator includes a depth indication mechanism.

36. The method of claim 17, wherein the conduit is threaded.

37. The method of claim 17, wherein the conduit is nonthreaded.

38. The method of claim 17, wherein the conduit is in position over the dilator during the inserting of the dilator.

39. A method of providing direct blood flow between a heart chamber and a coronary vessel, the method comprising:

placing a guide device through an anterior wall and a posterior wall of the coronary vessel and through a heart wall between the heart chamber and the coronary vessel;

forming a passageway in the heart wall at a location defined by the guide device; and

placing a conduit within the passageway by screwing the conduit into the heart wall.

40. The method of claim 39, further comprising inserting a hollow needle through the anterior wall and posterior wall of the coronary vessel and the heart wall prior to placing the guide device.

41. The method of claim 39, further comprising placing the guide device at an angle relative to the posterior wall of the coronary vessel.

42. The method of claim 39, wherein forming the passageway includes dilating the heart wall.

43. The method of claim 39, further comprising measuring a distance from the anterior wall of the coronary vessel to the heart chamber prior to placing the guide device.

44. The method of claim 39, wherein the guide device is a guidewire.

45. A method of providing direct blood flow between a heart chamber and a coronary vessel, the method comprising:

positioning a guide device external to the coronary vessel and moving a distal tip of the guide device toward an external surface of an anterior wall of the coronary vessel;

placing the guide device through at least one wall of the coronary vessel and through a heart wall between the heart chamber and the coronary vessel;

forming a passageway in the heart wall at a location defined by the guide device by inserting a dilator over the guide device at the location; and

placing a conduit within the passageway,

wherein the conduit is positioned over the dilator for placement within the passageway.

46. The method of claim 45, wherein the guide device is placed through the anterior wall of the coronary vessel and a posterior wall of the coronary vessel.

47. The method of claim 45, further comprising inserting a hollow needle through the at least one wall and the heart wall prior to placing the guide device.

48. The method of claim 45, further comprising placing the guide device at an angle relative to a posterior wall of the coronary vessel.

49. The method of claim 45, wherein the guide device is a guidewire.

50. The method of claim 45, wherein the dilator includes a bleed hole.

51. The method of claim 45, wherein the dilator includes a depth indication mechanism.

52. The method of claim 45, wherein the conduit is threaded.

53. The method of claim 45, wherein the conduit is nonthreaded.

54. The method of claim 45, wherein the conduit is in position over the dilator during the inserting of the dilator.