Implantable lead having self-locking suture sleeve

• US 5,476,493 A
• Filed: 05/19/1993
• Issued: 12/19/1995
• Est. Priority Date: 05/19/1993
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Muff, Diane M.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Parker, Marianne
• Application Number:
  US08/064,681
• Time in Patent Office: 944 Days
• Field of Search: 607/119, 607/132, 128/642, 128/639, 604/171, 604/174, 604/175, 604/178, 604/180
• US Class Current: 607/119
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0582 Suture sleeves

Abstract

A movable self-locking suture sleeve which can be securely positioned on the lead body of a pacing lead. The self-locking suture sleeve includes first and second cooperative rigid elements interconnected by a flexible tubing element. The tubing element is constructed from a woven mesh designed to constrict when stretched. A resilient element or spring is interposed between the first and second cooperative rigid elements, tending to force the cooperative rigid elements axially apart. Once the suture sleeve is moved into position, a self-locking feature allows the suture sleeve to secure itself to the lead body.

Claims

1. An implantable lead comprising:

a lead body extending between a proximal end and a distal end, the lead body having an outer diameter;

an electrical connector element positioned at the proximal end of the lead body;

an electrode assembly positioned at the distal end of the lead body; and

a self-locking suture sleeve having a first end and a second end, the suture sleeve movable about at least a portion of the lead body between the proximal end and the distal end, the self-locking suture sleeve comprising;

a tubing element having a first end and a second end, the tubing element axially disposed about the outer diameter of the lead body, the tubing element first and second ends being affixed to respective ones of the ends of the self-locking suture sleeve;

means for elongating the tubing element so that the tubing element constrictably grips the lead body.

2. The implantable lead of claim 1, wherein the tubing element comprises a cylindrical woven mesh of biocompatible material, the mesh being woven so that the mesh has a smaller inner diameter when the mesh is elongated and a wider inner diameter when the mesh is compressed.

3. The implantable lead of claim 2, wherein the biocompatible material comprises a polymer material.

4. The implantable lead of claim 2, wherein the biocompatible material comprises a metallic material.

5. The implantable lead of claim 1, wherein the tubing element comprises a cylindrical element formed from a resilient, biocompatible elastomeric material.

6. The implantable lead of claim 1, wherein the elongating means comprises:

a resilient element coupled to the tubing element and operable between a relaxed state and a compressed state such that when the resilient element is in a compressed state the tubing element is in a relaxed state, and when the resilient element expands to its relaxed state the tubing element constricts.

7. The implantable lead of claim 6, wherein the resilient element comprises a spring element.

8. The implantable lead of claim 7, wherein the resilient element comprises a compression spring.

9. The implantable lead of claim 7, wherein the resilient element comprises a torsion spring.

10. The implantable lead of claim 6, wherein the self-locking suture sleeve further comprises:

a first housing means for receiving the tubing element, the first housing means having a generally cylindrical configuration including an internal bore, the first housing means further having a first end and a second end;

a second housing means for receiving the tubing element, the second housing means having a first end and a second end and having a generally cylindrical portion, the generally cylindrical portion having an outer diameter allowing at least partial insertion of the first end of the second housing means into the internal bore of the first housing means at the first end of the first housing means; and

further

wherein the tubing element is axially disposed about the outer diameter of the lead body, the tubing element being affixed at its first and second ends to the second ends of the first and second housing means respectively.

11. The implantable lead of claim 10, wherein the resilient element is a spring positioned to bias the first and second housing means so that when the resilient element is in a compressed state the tubing element is in a relaxed state, and when the resilient element expands to its relaxed state the tubing element constricts.

12. The implantable lead of claim 1, wherein the elongating means includes means for causing relative rotation of the first and second housing means.

13. The implantable lead of claim 12, wherein the means for causing relative rotation of the first and second housing means comprises a torsion spring.

14. The implantable lead of claim 12, wherein the means for causing relative rotation of the first and second housing means comprises:

a projecting element extending from a surface of the first housing means;

a helical groove formed within an adjacent surface of the second housing means, whereby said projecting element extends into and helically tracks the helical groove; and

resilient means for biasing the first and second housing means causing relative motion therebetween.

15. The implantable lead of claim 12, wherein the means for causing relative rotation of the first and second housing means comprises:

a projecting element extending from a surface of the second housing means;

a helical groove formed within an adjacent surface of the first housing means, whereby said projecting element extends into and helically tracks the helical groove; and

resilient means for biasing the first and second housing means causing relative motion therebetween.

16. An implantable lead comprising:

a lead body having an outer diameter; and

a self-locking suture sleeve comprising;

a first rigid element having a generally cylindrical configuration including a stepped internal bore, the first rigid element having a first end and a second end;

a second rigid element having a generally cylindrical portion, the second rigid element having a first end and a second end, and having an outer diameter allowing at least partial insertion of the first end of the second rigid element into the internal bore of the first rigid element, at the first end of the first rigid element;

a tubing element axially disposed about the outer diameter of the lead body, the tubing element affixed at its first and second ends to the second ends of the first and second rigid elements respectively; and

means for elongating the tubing element so that the diameter of at least a portion of the tubing element constricts about the lead body.

17. The implantable lead of claim 16, wherein the elongating means comprises:

a resilient element operable between a relaxed state and a compressed state, wherein when the resilient element is in a compressed state the tubing element is in a relaxed state, and when the resilient element expands to its relaxed state the tubing element constricts.

18. The implantable lead of claim 17, wherein the resilient element comprises a compression spring.

19. The implantable lead of claim 16, wherein the tubing element comprises a cylindrical woven mesh of biocompatible material.

20. The implantable lead of claim 19, wherein the biocompatible material comprises a polymer material.

21. The implantable lead of claim 19, wherein the biocompatible material comprises a metallic material.

22. The implantable lead of claim 16, wherein the tubing element comprises a cylindrical element formed from a resilient, biocompatible elastomeric material.

23. The implantable lead of claim 16, wherein the elongating means comprises:

means for causing relative rotation of the first and second rigid elements.

24. The implantable lead of claim 23, wherein the means for causing relative rotation of the first and second rigid elements comprises a torsion spring.

25. The implantable lead of claim 23, wherein the means for causing relative rotation of the first and second rigid elements comprises:

a projecting element extending from a surface of the first rigid element;

a helical groove formed within an adjacent surface of the second rigid element, whereby said projecting element extends into and helically tracks the helical groove; and

resilient means for biasing the first and second rigid elements causing relative motion therebetween.

26. The implantable lead of claim 23, wherein the means for causing relative rotation of the first and second rigid elements comprises:

a projecting element extending from a surface of the second rigid element;

a helical groove formed within an adjacent surface of the second rigid element, whereby said projecting element extends into and helically tracks the helical groove; and

resilient means for biasing the first and second rigid elements causing relative motion therebetween.

27. A method of securing an suture sleeve onto an implantable lead, the suture sleeve having a first end and a second end, and further having a cylindrical woven mesh of biocompatible material affixed to the first and second ends, the implantable lead comprising a lead body having an outer diameter, comprising the steps of:

placing the suture sleeve on the implantable lead whereby such that the cylindrical woven mesh of biocompatible material is axially disposed about the outer diameter of the lead body; and

forcibly constricting at least a portion of the cylindrical woven mesh of biocompatible material, thereby frictionally securing the suture sleeve onto the lead body.

28. A method for forming a suture sleeve comprising the steps of:

forming a first rigid element having a generally cylindrical configuration including an internal bore, the first rigid element having a first end and a second end;

forming a second rigid element having a generally cylindrical portion, the second rigid element having a first end and a second end;

partially inserting the first end of the second rigid element into the internal bore of the first rigid element at the first end of the first rigid element;

affixing a first end and a second end of a cylindrical woven mesh of biocompatible material to the second ends of the first and second rigid elements respectively; and

biasing the first and second rigid elements with a resilient element so that when the resilient element is forced into a compressed state the cylindrical woven mesh of biocompatible material is in a relaxed state and the suture sleeve is slidable about a lead body, and when the resilient element is released the cylindrical woven mesh of biocompatible material grips the lead body.

29. The method as recited in claim 28, wherein the biasing step comprises:

rotating the first and second rigid elements along a helical track thereby causing relative rotation therebetween.

30. An implantable lead comprising:

a lead body having an outer diameter, the lead body extending between a proximal end and a distal end;

an electrical connector element positioned at a proximal end of the lead body;

an electrode assembly positioned at the distal end of the lead body; and

a self-locking suture sleeve movable about at least a portion of the lead body between the proximal end and the distal end the self-locking suture sleeve having a first end and a second end, the self-locking suture sleeve comprising;

a tubular woven mesh of biocompatible material axially disposed about the outer diameter of the lead body, the tubular woven mesh being affixed at its ends to the first and second ends of the self-locking suture sleeve, the tubular woven mesh having a smaller inner diameter when the tubular woven mesh is elongated and a wider inner diameter when the tubular woven mesh is compressed;

whereby the suture sleeve frictionally grips the lead body when the tubular woven mesh is elongated and enables the suture sleeve to slide when the tubular woven mesh is compressed.

31. The implantable lead of claim 30, wherein the biocompatible material comprises a polymer material.

32. The implantable lead of claim 30, wherein the biocompatible material comprises a metallic material.

33. The implantable lead of claim 30, wherein the self-locking suture sleeve further comprises:

a first cylindrical housing means for receiving the tubular woven mesh the first cylindrical housing means having an internal bore, a first end and a second end;

a second cylindrical housing means for receiving the tubular woven mesh, the second cylindrical housing means having a first end and a second end and further having an outer diameter dimensioned to fit within the internal bore of the first cylindrical housing means;

wherein the tubular woven mesh is affixed at its first and second ends to the second ends of the first and second cylindrical housing means respectively, the mesh being axially disposed about the outer diameter of the lead body; and

a spring element positioned to bias the first and second cylindrical housing means so that when the spring element is in a compressed state the tubular woven mesh is in a relaxed state, and when the spring element is in its relaxed state the tubular woven mesh constricts.

34. The implantable lead of claim 33, wherein the spring element comprises a compression spring.

35. The implantable lead of claim 33, wherein the first and second cylindrical housing means comprise:

a projecting element extending from a surface of the first cylindrical housing means;

a helical groove formed within an adjacent surface of the second cylindrical housing means, whereby said projecting element extends into and helically tracks the helical groove; and

wherein the spring element comprises a torsion spring for biasing the first and second cylindrical housing means causing relative motion therebetween.

36. The implantable lead of claim 33, wherein the spring element comprises a torsion spring.

37. The implantable lead of claim 33, wherein the first and second cylindrical housing means comprise:

a projecting element extending from a surface of the second cylindrical housing means;

a helical groove formed within an adjacent surface of the first cylindrical housing means, whereby said projecting element extends into and helically tracks the helical groove; and

wherein the spring element comprises a torsion spring for biasing the first and second cylindrical housing means causing relative motion therebetween.