Myocardial lead with fixation mechanism

• US 20050113900A1
• Filed: 10/22/2004
• Published: 05/26/2005
• 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, Yingling, David B.
• Granted Patent: US 7,418,298 B2
• Time in Patent Office: Days
• US Class Current: 607/130
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/0608 J-shaped
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61N 1/0568 with drug delivery
• 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
• CPC Class Codes: A61N 2001/058 Fixing tools

Abstract

The present invention is a myocardial lead attachment system and method for securing a distal end of a lead within the myocardium of a patient'"'"'s heart. The system includes an anchor, a tether coupled at a distal end to the anchor and a lead body. The lead body has a proximal end, a distal end, and a lumen extending therethrough for receiving the tether. A fixation mechanism is at the distal end of the lead body, and is adapted to collapse to a first configuration during implantation and deploy to a second configuration after implantation.

Claims

1. A myocardial lead attachment system for securing a distal end of a lead within the myocardium of a patient'"'"'s heart, the system comprising:

an anchor;

a tether coupled at a distal end to the anchor;

a lead body having a proximal end, a distal end, and a lumen extending therethrough for receiving the tether; and

a fixation mechanism at the distal end of the lead body, wherein the fixation mechanism is adapted to collapse to a first configuration during implantation and deploy to a second configuration after implantation.

2. The attachment system of claim 1 wherein the fixation mechanism is comprised of a number of tines radiating out from the distal end of the lead body in the second configuration.

3. The attachment system of claim 1 wherein the fixation mechanism is shaped like a disc in the second configuration.

4. The attachment system of claim 1 wherein the fixation mechanism is shaped like a ribbed tent in the second configuration.

5. The attachment system of claim 1 wherein the fixation mechanism is an inflatable balloon.

6. The attachment system of claim 5 wherein balloon deployment fluid is delivered to the fixation mechanism through the lumen.

7. The attachment system of claim 1 wherein the fixation mechanism has a first diameter in the first configuration and a second diameter in the second configuration greater than the first diameter.

8. The attachment system of claim 1 further comprising a cellular attachment feature on the fixation mechanism.

9. The attachment system of claim 1 further comprising a rapidly dissolvable coating on the fixation mechanism formed in such a manner as to retain the fixation mechanism in the first configuration.

10. The attachment system of claim 9 wherein the coating has a rounded shape.

11. The attachment system of claim 9 wherein the coating has a tissue dissecting shape.

12. The attachment system of claim 1 wherein the fixation mechanism includes a through hole for receiving the tether.

13. The attachment system of claim 12 further comprising a lock formed on the tether, wherein the through hole is sized to accept the lock.

14. The attachment system of claim 1 wherein the lead body includes a bias region adapted to absorb an axial force applied to the proximal end of the lead body.

15. The attachment system of claim 1 further comprising a drug collar coupled to the lead body near the distal end.

16. A method of implanting a myocardial lead attachment system, the method comprising:

providing a lead body having a proximal end, a distal end and a fixation mechanism positioned at the proximal end;

advancing the lead body and fixation mechanism over a tether through the myocardium while the fixation mechanism is in a first collapsed configuration; and

deploying the fixation mechanism to a second configuration on an epicardial surface of the heart to retain the lead body at a chosen location.

17. The method of claim 16 wherein deploying the fixation mechanism includes exerting a proximally directed axial force on the lead body.

18. The method of claim 16 wherein the method further includes:

rotating the fixation mechanism in a first direction to retain the fixation mechanism in the first configuration; and

deploying the fixation mechanism further includes rotating the fixation mechanism in a second direction.

19. The method of claim 16 wherein deploying the fixation mechanism further includes inflating the fixation mechanism with a deployment fluid.

20. The method of claim 16 wherein the method further comprises allowing a rapidly dissolvable coating on the fixation mechanism to dissolve before deploying the fixation mechanism to the second configuration.

21. The method of claim 16 wherein the method further includes fixing the fixation mechanism to the heart through cellular attachment.

22. The method of claim 16 wherein the method further includes:

delivering an anchor mechanism coupled to the tether into the heart;

threading the lead body onto the tether; and

advancing the lead body over the tether into the heart.

23. The method of claim 22 further comprising allowing of the anchor mechanism or the tether to dissolve.

24. The method of claim 16 wherein the method further includes:

coupling a proximal end of a pull-through type tether to the lead body and a distal end of the tether to a needle;

advancing the needle through the heart; and

advancing the lead further includes pulling the lead body behind the needle with the tether.