Spring fixation mechanism for epicardial leads

• US 7,496,410 B2
• Filed: 01/10/2005
• Issued: 02/24/2009
• Est. Priority Date: 01/10/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Heil, Ronald W. Jr.
• Primary Examiner(s): Bockelman; Mark W
• Assistant Examiner(s): Dinga; Roland
• Application Number:
  US11/032,445
• Publication Number:
  US 20060155353A1
• Time in Patent Office: 1,506 Days
• Field of Search: 607/116, 607/119, 607/126, 607/127, 607/122, 600/375, 600/374, 600/373
• US Class Current: 607/126
• CPC Class Codes: A61N 1/0575 with drug delivery
• CPC Class Codes: A61N 1/059 Anchoring means

Abstract

A spring fixation mechanism is adapted for fixing the distal end of an epicardial lead in a myocardium of the heart. The spring fixation mechanism is positioned at a distal end of the lead and includes a spring member and a stop. The spring member is formed about the lead and extends from a proximal end slidable relative to the lead to a distal end fixed to the lead. The stop is coupled to the proximal end of the spring member and is sized to be retained outside of an epicardium of the heart. The distal end of the lead, including the spring fixation mechanism, is inserted into the myocardium with a stylet and/or a pusher tube. The spring member is loaded and released, grasping tissue between adjacent coils of the spring member, fixing the lead within the myocardium.

Claims

1. A lead for insertion into a myocardium of a heart, the lead comprising:

a lead body defining a lumen extending therethrough, the lead body having a proximal end, a distal end and one or more conductors disposed therein, the lead body distal end having an exit port for the lumen;

a stylet slidably disposed in the lumen and having a sharpened distal end, the stylet having a size and length sufficient to pass through the lumen and exit the lumen through the distal port such that the sharpened distal end can be extended from the lead body distal end to pierce the myocardium, providing a pilot hole for the lead body;

an electrode coupled near the distal end of the lead body; and

a spring fixation mechanism including a spring member and a stop, the spring member formed about the lead body and extending from a spring proximal end slidable relative to the lead body to a spring distal end fixed to the lead body, the stop coupled to the spring proximal end and sized to be retained outside of an epicardium of the heart such that as the lead body is advanced into the epicardium using a distally directed axial force, the spring is stretched between the stop and the distal end of the spring, and, upon removal of the axial force, the spring retracts, capturing epicardial tissue between coils of the spring.

2. The lead of claim 1 further comprising a dilator slidably received over the stylet.

3. The lead of claim 1 further comprising a rigid tube slidably received in the lumen, and wherein a distal end of the lumen is formed with an internal stop for transmitting a longitudinally directed force from the tube to the distal end of the lead.

4. The lead of claim 1 further comprising a tensioning member having a distal end coupled to the stop and extending proximally therefrom.

5. The lead of claim 4 wherein the tensioning member is formed from either of a biodegradable or bioabsorbable material.

6. The lead of claim 4, wherein the tensioning member is a cord.

7. The lead of claim 1 wherein the spring fixation mechanism further comprises an attachment ring coupling the spring distal end to the lead body.

8. The lead of claim 1 wherein the spring member is a close-wound extension coil spring.

9. The lead of claim 1 wherein the spring member is provided with a texturized outer surface.

10. The lead of claim 1 wherein the spring member is provided with an outer surface adapted to promote tissue ingrowth.

11. The lead of claim 1 wherein the spring member is a second electrode.

12. The lead of claim 1 wherein the spring member has a length of from about 5 mm to about 10 mm.

13. The lead of claim 1 further comprising a drug collar positioned on the distal end of the lead body.

14. The lead of claim 1 wherein the spring fixation mechanism further comprises at least one tine member pivotably coupled to the lead and deployable from a collapsed configuration to a protruding configuration upon elongation of the spring member.

15. The lead of claim 1 wherein the spring fixation mechanism further includes a wedge-shaped member positioned on the lead distal to the stop, the wedge-shaped member having a smaller end facing distally and a larger end facing proximally.

16. A lead for insertion through an epicardium and into a myocardium of a heart, the lead comprising:

a lead body defining a lumen extending therethrough, the lead body having a proximal end, a distal end and one or more conductors disposed therein, the lead body distal end having an exit port for the lumen;

a stylet slidably disposed in the lumen and having a sharpened distal end, the stylet having a size and length sufficient to pass through the lumen and exit the lumen through the distal port such that the sharpened distal end can be extended from the lead body distal end to pierce the myocardium, providing a pilot hole for the lead body;

an electrode coupled near the distal end of the lead body;

a spring fixation mechanism including a spring member and a stop, the spring member formed about the lead body and extending from a spring proximal end to a spring distal end fixed to the lead body, the spring proximal end slidable relative to the lead body such that the lead body can be held immobile while the proximal end is slid along the lead body, the stop coupled to the spring proximal end and sized to be retained outside of an epicardium of the heart, wherein the stop has a first position along the lead body corresponding to a contracted configuration of the spring and a second position along the lead body corresponding to an extended configuration of the spring, the first position being distal of the second position; and

a tensioning member having a distal end coupled to the stop and extending proximally therefrom, the tensioning member slidable relative to the lead body such that placing tension on the tensioning member while holding the lead body immobile causes the proximal end of the spring member to be moved proximally along the lead body, stretching the spring member.

17. The lead of claim 16 wherein adjacent windings of the spring are abutting one another in the contracted configuration.

18. The lead of claim 16 wherein adjacent windings of the spring are spaced apart from one another in the contracted configuration.

19. The lead of claim 16 further comprising a rigid tube slidably received in the lumen, and wherein a distal end of the lumen is formed with an internal stop for transmitting a longitudinally directed force from the tube to the distal end of the lead.

20. The lead of claim 16 wherein the spring fixation mechanism further comprises at least one tine member pivotably coupled to the lead and deployable from a collapsed configuration to a protruding configuration upon elongation of the spring member.

21. The lead of claim 16 wherein the spring fixation mechanism further includes a wedge-shaped member positioned on the lead distal to the stop, the wedge-shaped member having a smaller end facing distally and a larger end facing proximally.

22. The lead of claim 16 wherein the spring member is a second electrode.

23. The lead of claim 16, wherein the tensioning member is a cord.