Distal or proximal fixation of over-the-tether myocardial leads

• US 20050137674A1
• Filed: 10/22/2004
• Published: 06/23/2005
• Est. Priority Date: 10/24/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Westlund, Randy W., Heil, Ronald W. Jr., Kelley, Peter T., Shiroff, Jason Alan, Coe, M. Sean, Palme, Donald F. II
• Granted Patent: US 7,499,759 B2
• Time in Patent Office: Days
• US Class Current: 607/130
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

The present invention is a myocardial lead attachment system for securing a lead within the myocardium. The attachment system includes an anchor configured to engage the heart, a tether coupled to the anchor and a lead body. The lead body has a proximal end, a distal end, a lumen for accepting the tether and a lock housing in the lumen. A lock structure is on the tether and mates with the lock housing and restrains motion of the lead with respect to the tether in either of a proximal or a distal direction.

Claims

1. A myocardial lead attachment system for securing a lead within the myocardium, the system comprising:

an anchor configured to engage the heart;

a tether coupled to the anchor and a lock structure on the tether; and

a lead body having;

a proximal end and a distal end,

a lumen for accepting the tether, and

a lock housing in the lumen, wherein the lock structure mates, with the lock housing and restrains motion of the lead body with respect to the tether in either of a proximal or a distal direction.

2. The system of claim 1 wherein the lock structure has a diameter greater than a diameter of the lumen and wherein at least a portion of the lead body is resiliently deflectable to accept the lock structure into the lumen and return to an undeflected state when the lock structure is advanced into the lock housing.

3. The system of claim 1 wherein the lock structure is generally shaped as a wedge having an angled leading face and a trailing face extending perpendicular to the tether.

4. The system of claim 1 wherein the lock structure is a knot tied in the tether.

5. The system of claim 1 further comprising:

a through-hole extending from the lumen through the lead body at a location the same as or proximal to the housing for receiving a portion of the tether proximal to the lock structure; and

a second lock structure on the tether coupling the tether to the lead body adjacent the through-hole.

6. The system of claim 5 wherein the second lock structure is a knot tied in the tether.

7. The system of claim 5 wherein the second lock structure is a slidable cinch crimped onto the tether.

8. The system of claim 5 wherein the lead body further includes a pocket for receiving the second lock structure.

9. The system of claim 1 wherein the tether further includes a proximal lock adapted to mate with the proximal end of the lead body, such that the lead body is restrained from longitudinal motion with respect to the tether.

10. The system of claim 9 wherein the proximal lock is a wedge inserted into the lead lumen at the proximal end of the lead body in frictional engagement with the tether.

11. The system of claim 9 wherein the proximal lock is a knot tied in the tether and sized larger than a diameter of the lumen.

12. The system of claim 11 wherein a proximal portion of the lumen tapers outwardly to receive the knot.

13. The system of claim 11 wherein a proximal portion of the lumen angles outwardly to receive the knot.

14. The system of claim 11 wherein a proximal portion of the lumen is chamfered to form a proximal region having a first diameter that is sized to receive the knot and a distal region having a second diameter that is sized to prevent entry of the knot further into the lumen.

15. The system of claim 9 wherein the proximal lock comprises:

a lock pin at the proximal end of the lead body, the lock pin having a first channel for receiving the tether and a side groove for receiving the tether under tension; and

an insert pin received in the lock pin for retaining the tether under tension.

16. A myocardial lead attachment system for securing a lead within the myocardium, the system comprising:

an anchor configured to engage the heart;

a tether coupled to the anchor;

a lead body having;

a proximal end and a distal end, and

a lumen for accepting the tether;

a distal lock for engaging the tether to the distal end of the lead body, the distal lock comprising;

a lock structure formed on a distal end of the tether, and

a lock housing in the lumen, wherein the lock structure mates with the lock housing and restrains motion of the lead body with respect to the tether in either of a proximal or a distal direction; and

a proximal lock for engaging the tether to the lead body proximal to the distal lock, the proximal lock comprising;

a through-hole extending from the lumen through the lead body at a location the same as or proximal to the lock housing for receiving a portion of the tether proximal to the distal lock, and

a second lock structure on the tether coupling the tether to the lead body adjacent the through-hole.

17. A myocardial lead attachment system for securing a lead within the myocardium, the system comprising:

an anchor configured to engage the heart;

a tether coupled to the anchor;

a lead body having;

a proximal end and a distal end, and

a lumen for accepting the tether;

a distal lock for engaging the tether to the distal end of the lead body, the distal lock comprising;

a lock structure formed on a distal end of the tether, and

a lock housing in the lumen, wherein the lock structure mates with the lock housing and restrains motion of the lead body with respect to the tether in either of a proximal or a distal direction; and

a proximal lock formed on the tether and adapted to mate with the proximal end of the lead body, the proximal lock comprising a second lock structure formed on the tether for fixing the tether in frictional engagement to the proximal end of the lead body.

18. A method of securing a myocardial lead in the myocardium, the method comprising:

advancing an anchor coupled to a distal end of a tether through the myocardium to an implant location;

threading a myocardial lead onto the tether;

advancing the lead over the tether to the implant location;

locking a distal end of the lead onto the distal end of the tether at a first attachment site;

tensioning the tether; and

securing the tether to the lead at a second attachment site proximal to the first attachment site.

19. The method of claim 18 wherein securing the tether to the lead at the second attachment site further includes:

threading the tether through a hole in the lead positioned proximal to the first attachment site;

tensioning the tether; and

forming a knot in the tether having a diameter greater than a diameter of the hole to retain the tensioned knot outside of the hole.

20. The method of claim 18 wherein securing the tether to the lead at the second attachment site further includes:

threading the tether through a hole in the lead positioned proximal to the first attachment site;

tensioning the tether;

sliding a cinch over the tether to a position adjacent the hole; and

crimping the cinch onto the tether.

21. The method of claim 18 wherein the step of securing the tether to the lead at the second attachment site further includes securing a proximal end of the tether in frictional engagement with a proximal end of the lead.

22. The method of claim 21 wherein the step of securing the tether to the lead at the second attachment site further includes forming a knot at a proximal end of the tensioned tether of a size sufficient to retain the knot outside of a lumen extending through the lead.

23. The method of claim 21 wherein the step of securing the tether to the lead at the second attachment site further includes inserting a wedge into lumen of the lead in frictional engagement with the tether.

24. The method of claim 18 further comprising discarding a trailing end of the tether proximal to the second attachment site.