Device and method for retaining a medical device within a vessel

• US 20040249431A1
• Filed: 06/04/2003
• Published: 12/09/2004
• Est. Priority Date: 06/04/2003
• Status: Active Grant

• Current Assignee: Nuxcel2 LLC
• Original Assignee: Synecor LLC
• Inventors: Williams, Michael S., Ransbury, Terrance
• Granted Patent: US 8,239,045 B2
• Time in Patent Office: Days
• US Class Current: 607/126
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

A method and apparatus for retaining a medical device within a blood vessel are described. A medical device (e.g. a pulse generator or a lead) is positioned within a blood vessel. An expandable the retention sleeve is passed into the vessel adjacent to the medical device and expanded to an expanded position to engage the medical device between an exterior surface of the retention sleeve and a surface of the vessel.

Claims

1. A method for retaining a medical device within a blood vessel, comprising the steps of:

providing a retention sleeve, the retention sleeve expandable from a compressed position to an expanded position;

introducing a medical device into a blood vessel;

with the retention sleeve in the compressed position, positioning the retention sleeve in the vessel adjacent to the medical device; and

expanding the retention sleeve to the expanded position to engage the medical device between an exterior surface of the retention sleeve and a surface of the vessel.

2. The method of claim 1 wherein the retention sleeve substantially minimizes blood flow between the retention sleeve and the medical device.

3. The method of claim 1 wherein the retention sleeve includes a tubular member having end sections and an intermediate section between the end sections, and wherein the method includes positioning the intermediate section adjacent to the device, and radially expanding at least a portion of the end sections into contact with the vessel.

4. The method of claim 3 wherein at least one of the end sections forms a seal against the vessel wall.

5. The method of claim 3 further including the step of causing at least a portion of the intermediate section to conform to a surface of the device.

6. The method of claim 3, wherein the method includes the step of positioning the retention sleeve in the compressed position within a positioning sheath, and wherein the expanding step includes releasing the retention sleeve from the positioning sheath.

7. The method of claim 6 wherein the expanding step includes causing the retention sleeve to self-expand after being released from the positioning sheath.

8. The method of claim 6 wherein the expanding step includes positioning an expansion device within the retention sleeve and expanding the expansion device.

9. The method of claim 8 wherein the expansion device is a balloon.

10. The method of claim 1 wherein the medical device is a pulse generator.

11. The method of claim 1 wherein the medical device is a lead.

12. The method of claim 1, further including the steps of positioning a liner within the vessel and positioning the medical device within the liner, and wherein the expanding step include expanding the retention sleeve within the liner to engage the medical device between the retention sleeve and the liner.

13. The method of claim 12 wherein the liner is an elongate tubular liner.

14. The method of claim 13 wherein the step of positioning the liner within the vessel includes the steps of passing the liner in a compressed position into the vessel, and expanding the liner into contact with the vessel wall.

15. The method of claim 14 wherein the step of passing the liner in a compressed position into the vessel includes the step of positioning the liner within a sheath, and wherein the expanding step includes releasing the liner from the sheath.

16. The method of claim 15, including the step of causing the liner to self-expand after being released from the sheath.

17. The method of claims 14, including the step of positioning an expansion device within the liner and expanding the expansion device.

18. The method of claim 17 wherein the expansion device is a balloon.

19. The method of claim 14:

wherein the method includes the step of, prior to introducing the liner, medical device and retention device into the vessel, inserting the medical device and retention device into the liner, causing the medical device to be sandwiched between the liner and retention device; and

wherein the liner and retention device, with the medical device sandwiched between them, are simultaneously positioned within the vessel.

20. The method of claim 12 wherein the liner has a length that is longer than a length of the medical device.

21. The method of claim 12 wherein expanding the retention sleeve within the liner causes the medical device to be sandwiched between the liner and the retention sleeve.

22. A retention device for retaining a medical device within a blood vessel, comprising:

a tubular member proportioned for receipt within a vessel adjacent to a medical device to be retained within the vessel, at least a portion of the tubular member being radially expandable to radially engage a vessel wall and to thereby retain the medical device against the vessel wall.

23. The retention device of claim 22, wherein the tubular member includes radially expandable end sections proportioned to radially engage a vessel wall.

24. The retention device of claim 22 wherein the tubular member includes end sections and a conformable intermediate section between the end sections.

25. The retention device of claim 22 wherein the tubular member includes a blood-impermeable barrier.

26. The retention device of claim 25 wherein the barrier includes a non-thrombogenic surface.

27. The retention device of claim 26 wherein the non-thrombogenic surface is configured to elute a non-thrombogenic or anti-platelet agent.

28. The retention device of claim 25 wherein the barrier includes an anti-profilferative surface.

29. The retention device of claim 27 wherein the anti-proliferative surface is configured to elute an anti-proliferative agent.

30. The retention device of claim 25 wherein the barrier includes a surface configured to elute an immunosupressive agent.

31. The retention device of claim 33 wherein each of the end sections includes a framework.

32. The retention device of claim 25 wherein the blood-impermeable barrier is on the exterior surface of the tubular member.

33. The retention device of claim 25 wherein the blood-impermeable barrier is on the interior surface of the tubular member.

34. The retention device of claim 31 wherein the intermediate section includes a second framework, the second framework having less rigidity than the framework of the end sections.

35. The retention device of claim 22, further including a tubular vessel liner, wherein the tubular member is proportioned to be received within the vessel liner within a vessel, such that the retention device retains the medical device between the retention device and the liner.

36. A system for retaining a medical device within a blood vessel, the system comprising:

a fluid impermeable vessel liner proportioned to be received with a vessel;

a medical device positionable within the vessel liner; and

an expandable retention device proportioned to be telescopically received within the vessel liner, the tubular member radially expandable within the vessel liner into contact with medical device to thereby retain the medical device between the tubular member and the vessel liner.

37. The system of claim 36 wherein the vessel liner is a radially expandable tubular member.

38. The system of claim 37 wherein the vessel liner has a length that is longer than the length of the medical device.

39. The system of claim 38 wherein the length of the vessel liner is longer than the length of the retention device.

40. The system of claim 36 wherein the retention device is a radially expandable tubular member.

41. The system of claim 36 wherein the retention device includes at a pair of end sections configured to make sealing contact against the liner.

42. The system of claim 36 wherein the medical device is a pulse generator.

43. The system of claim 36 wherein the medical device is a lead.

44. The system of claim 40 wherein the tubular member includes a blood-impermeable barrier.

45. The system of claim 44 wherein the barrier includes a non-thrombogenic surface.

46. The system of claim 45 wherein the non-thrombogenic surface is configured to elute a non-thrombogenic or anti-platelet agent.

47. The system of claim 44 wherein the barrier includes an anti-proliferative surface.

48. The system of claim 47 wherein the anti-proliferative surface is configured to elute an anti-proliferative agent.

49. The system of claim 44 wherein the barrier includes a surface configured to elute an immunosupressive agent.

50. The system of claim 36 wherein the liner includes a non-thrombogenic surface.

51. The system of claim 50 wherein the non-thrombogenic surface is configured to elute a non-thrombogenic or anti-platelet agent.

52. The system of claim 36 wherein the liner includes an anti-proliferative surface.

53. The system of claim 52 wherein the anti-proliferative surface is configured to elute an anti-proliferative agent.

54. The system of claim 36 wherein the liner includes a surface configured to elute an immunosupressive agent.