Device and method for retaining a medical device within a vessel

• US 8,239,045 B2
• Filed: 06/04/2003
• Issued: 08/07/2012
• Est. Priority Date: 06/04/2003
• Status: Active Grant

• Current Assignee: Nuxcel2 LLC
• Original Assignee: Synecor LLC
• Inventors: Ransbury, Terrance, Williams, Michael S.
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US10/453,971
• Publication Number:
  US 20040249431A1
• Time in Patent Office: 3,352 Days
• Field of Search: 607/119, 607/122, 607126-128
• US Class Current: 607/119
• 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:

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

introducing a medical device into a blood vessel, wherein the medical device comprises an elongated pulse generator having a generally cylindrical construction with a circular cross-section that forms a hermetically sealed housing containing circuitry and a battery, the elongated pulse generator being configured to be flexible about a longitudinal axis such that the step of introducing the medical device includes bending of the pulse generator in response to passage of the device through curved regions of the vasculature;

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, further including the steps of positioning a liner within the vessel and subsequently positioning the medical device within the liner, and wherein the expanding step includes expanding the retention sleeve within the liner to engage the medical device between the retention sleeve and the liner.

11. The method of claim 10 wherein the liner is an elongate tubular liner.

12. The method of claim 11 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.

13. The method of claim 12 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.

14. The method of claim 13, including the step of causing the liner to self-expand after being released from the sheath.

15. The method of claim 12, including the step of positioning an expansion device within the liner and expanding the expansion device.

16. The method of claim 15 wherein the expansion device is a balloon.

17. The method of claim 12:

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.

18. The method of claim 10 wherein the liner has a length that is longer than a length of the medical device.

19. The method of claim 10 wherein expanding the retention sleeve within the liner causes the medical device to be sandwiched between the liner and the retention sleeve.

20. 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, wherein the medical device comprises an elongated pulse generator having a generally cylindrical construction with a circular cross-section that forms a hermetically sealed housing containing circuitry and a battery, the elongated pulse generator being configured to be flexible about a longitudinal axis such that the medical device bends in response to passage of the pulse generator through curved regions of the vasculature; and

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

21. The system of claim 20 wherein the vessel liner is a radially expandable tubular member.

22. The system of claim 21 wherein the vessel liner has a length that is longer than the length of the medical device.

23. The system of claim 22 wherein the length of the vessel liner is longer than the length of the retention device.

24. The system of claim 20 wherein the retention device is a radially expandable tubular member.

25. The system of claim 20 wherein the retention device includes a pair of end sections configured to make sealing contact against the liner.

26. The system of claim 24 wherein the tubular member includes a blood impermeable barrier.

27. The system of claim 20, wherein the liner includes a surface selected from the group consisting of a non-thrombogenic surface, a non-thrombogenic surface configured to elute a non-thrombogenic or anti-platelet agent, an anti-proliferative surface, an anti-proliferative surface configured to elute an anti-proliferative agent, and a surface configured to elute an immunosuppressive agent.

28. The system of claim 26, wherein the barrier includes a surface selected from the group consisting of a non-thrombogenic surface, a non-thrombogenic surface configured to elute a non-thrombogenic or anti-platelet agent, an anti-proliferative surface, an anti-proliferative surface configured to elute an anti-proliferative agent, and a surface configured to elute an immunosuppressive agent.

29. A method for providing a medical device and providing instructions for retaining the medical device within the vasculature of a patient, comprising:

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

providing an elongated medical device, the medical device comprising a pulse generator having a generally cylindrical construction with a circular cross-section that forms a hermetically sealed housing containing circuitry and a battery, the medical device having a longitudinal length that is longer than the longitudinal length of the retention sleeve and being configured to be flexible about a longitudinal axis; and

providing instructions to implant the medical device in the vasculature of the patient, including;

positioning the medical device entirely within the vasculature of a patient, including bending the pulse generator in response to passage of the device through curved regions of the vasculature;

with the retention sleeve in the compressed position, positioning the retention sleeve in the vasculature adjacent to a portion of 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 an interior surface of the vasculature.

30. 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 having a generally cylindrical construction with a circular cross-section and a longitudinal length section that forms a hermetically sealed housing containing circuitry and a battery, the elongated pulse generator being configured to be flexible about a longitudinal axis such that the medical device bends in response to passage of the pulse generator through curved regions of the vasculature; and

an expandable retention device proportioned to be compressibly received within the vessel liner, the retention device having a longitudinal length that is less than the longitudinal length of the medical device, the retention device expandable within the vessel liner into contact with a portion of the medical device to thereby retain the medical device between the retention device and the vessel liner.