Pacing lead stabilizer

• US 7,184,841 B1
• Filed: 08/19/2004
• Issued: 02/27/2007
• Est. Priority Date: 08/19/2004
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bodner, Jeffrey P., Finlay, Matthew S., Yingling, David B., Laabs, Matthew C., Yrimia, Yvo A., Rodriguez, Luis M.
• Primary Examiner(s): Pezzuto; Robert E.
• Assistant Examiner(s): Gedeon; Brian T.
• Application Number:
  US10/921,520
• Time in Patent Office: 922 Days
• Field of Search: 607/119, 607/122, 607/125, 607/132
• US Class Current: 607/122
• 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 lead assembly for use with an implantable cardiac function management system. The lead assembly includes an elongated flexible pacing lead having a proximal end and a distal end. A terminal connector is connected to the proximal end of the pacing lead and has a distal end formed with a first coupling feature. A pacing lead stabilizer having a central bore is mounted on the pacing lead and is slidable along the pacing lead. The pacing lead stabilizer has a stabilizer proximal end formed with a mating feature complementary to the first coupling feature, such that the pacing lead stabilizer is releasably coupleable to the terminal connector.

Claims

1. A lead assembly for use with an implantable cardiac function management system, the lead assembly comprising:

an elongated flexible pacing lead having a proximal end and a distal end;

a terminal connector connected to the proximal end of the pacing lead and having a distal end formed with a first coupling feature; and

a pacing lead stabilizer having a central bore mounted on the pacing lead and slidable along the pacing lead, the pacing lead stabilizer having a stabilizer proximal end formed with a mating feature complementary to the first coupling feature, such that the pacing lead stabilizer is releasably coupleable to the terminal connector.

2. The lead assembly of claim 1 wherein the pacing lead stabilizer includes a plurality of grooves formed on an outer surface for receiving suture threads.

3. The lead assembly of claim 1 wherein the first coupling feature is an annular ridge and the mating feature is an annular recess formed in the bore at the stabilizer proximal end, wherein the annular ridge is receivable in the annular recess.

4. The lead assembly of claim 3 wherein the recess includes a lip adapted to contact a trailing surface of the annular ridge.

5. The lead assembly of claim 1 wherein the first coupling feature and the second surface are complementary threads, such that the pacing lead stabilizer is threadably coupleable to the terminal connector.

6. The lead assembly of claim 1 wherein the central bore includes at least one radial protrusion, the protrusion adapted to contact an outer surface of the pacing lead.

7. A lead assembly for use with an implantable cardiac function management system, the lead assembly comprising:

an elongated flexible pacing lead having an electrode at a distal end and a terminal connector at a proximal end;

a pacing lead stabilizer having a central bore, the stabilizer coupled to the lead such that the lead extends through the central bore; and

separable anchor mechanism means for restricting linear movement of the pacing lead stabilizer with respect to the pacing lead wherein the anchor mechanism means comprises a separable mechanical interlock coupling the pacing lead stabilizer to the terminal connector.

8. The lead assembly of claim 7 wherein the mechanical interlock comprises a recess formed on a proximal end of the pacing lead stabilizer and a matching recess formed on a distal end of the terminal connector.

9. The lead assembly of claim 7 wherein the anchor mechanism means further comprises a threaded feature formed on a distal end of the terminal connector and a complementary threaded feature formed on a proximal end of the pacing lead stabilizer.

10. The lead assembly of claim 7 wherein the mechanical interlock further includes a member selected from the group consisting of:

a hook and eye, a bayonet, a snap-fit, and an inflatable bladder.

11. The lead assembly of claim 7 wherein the anchor mechanism means further comprises a separable adhesive bond coupling the pacing lead stabilizer to the pacing lead.

12. The lead assembly of claim 7 wherein the anchor mechanism means further comprises a separable adhesive bond coupling the proximal end of the pacing lead stabilizer to the terminal connector.

13. The lead assembly of claim 7 wherein the anchor mechanism means further comprises an elastic ring encircling the pacing lead stabilizer, the elastic ring exerting sufficient force on the pacing lead stabilizer to compress the pacing lead stabilizer about the pacing lead and generate a frictional force sufficient to retain the pacing lead stabilizer with respect to the pacing lead.

14. The lead assembly of claim 13 wherein the pacing lead stabilizer further comprises a proximal end overlapping a distal end of the terminal connector, wherein the elastic ring is positioned around the region of overlap to compress the pacing lead stabilizer onto the terminal connector.

15. The lead assembly of claim 7 wherein the anchor mechanism means further comprises a detachable tab extending from the pacing lead stabilizer, the tab sized to prevent the pacing lead stabilizer from entering an opening in an access vessel.

16. The lead assembly of claim 15 wherein the tab laterally extends from the pacing lead stabilizer a distance of from about 1 cm to about 2 cm.

17. The lead assembly of claim 15 wherein the tab has a length of from about 1 cm to about 2 cm and a width of from about 1 cm to about 2 cm.

18. The lead assembly of claim 15 wherein the anchor mechanism means further comprises a detachable C-ring supporting the tab and positioned on the pacing lead stabilizer to obscure a plurality of suture grooves.

19. A method of implanting a pacing lead assembly, the pacing lead assembly including a pacing lead having a surface electrode at a distal end, a terminal connector at a proximal end, a pacing lead stabilizer having a central bore slidably mounted to the pacing lead, and an anchor mechanism for restricting linear motion of the pacing lead stabilizer with respect to the pacing lead, the method comprising:

inserting the distal end of the pacing lead through an aperture in an access vessel to the heart;

advancing the pacing lead through the access vessel until the distal end of the pacing lead is positioned in or near the heart;

separating the anchor mechanism to allow full linear motion of the pacing lead stabilizer with respect to the pacing lead;

locating the pacing lead stabilizer at an appropriate position along the pacing lead for securing the pacing lead to the surrounding tissue; and

suturing the pacing lead stabilizer to the surrounding tissue and to the pacing lead to resist dislocation of the pacing lead retaining the pacing lead stabilizer adjacent the terminal connector throughout insertion and advancement of the pacing lead through the access vessel.

20. The method of claim 19 further comprising sliding the pacing lead stabilizer distally from the terminal connector to detach the pacing lead stabilizer from the terminal connector.

21. The method of claim 19 further comprising rotating the pacing lead stabilizer with respect to the terminal connector to detach the pacing lead stabilizer from the terminal connector.

22. The method of claim 19 further comprising removing a tab extending laterally from the pacing lead stabilizer.

23. The method of claim 19 further comprising removing a tab extending from the pacing lead.

24. The method of claim 19 further comprising breaking an adhesive bond between the pacing lead stabilizer and the terminal connector.

25. The method of claim 19 further comprising breaking an adhesive bond between the pacing lead stabilizer and the pacing lead.

26. The method of claim 19 further comprising separating the anchor mechanism to allow full linear motion of the pacing lead stabilizer with respect to the pacing lead then locating the pacing lead stabilizer at an appropriate position along the pacing lead for securing the pacing lead to the surrounding tissue.

27. The method of claim 19 further comprising locating the pacing lead stabilizer at an appropriate position along the pacing lead for securing the pacing lead to the surrounding tissue then separating the anchor mechanism to allow full linear motion of the pacing lead stabilizer with respect to the pacing lead.