Myocardial lead with fixation mechanism

• US 7,418,298 B2
• Filed: 10/22/2004
• Issued: 08/26/2008
• Est. Priority Date: 10/24/2003
• Status: Expired due to Fees

• 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.
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): PATEL, NATASHA
• Application Number:
  US10/971,549
• Publication Number:
  US 20050113900A1
• Time in Patent Office: 1,404 Days
• Field of Search: 607/126, 607/128, 607/125, 607/116, 607/122, 607/119, 607/123, 600/375
• US Class Current: 607/126
• 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 method of implanting a myocardial lead attachment system, the method comprising:

delivering an anchor mechanism coupled to a distal end of a tether to an epicardial surface;

threading a lead body having a proximal end, a distal end, a lumen extending through the lead body, and a fixation mechanism positioned at the distal end over a proximal end of the tether;

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

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

2. The method of claim 1 wherein deploying the fixation mechanism includes exerting a proximally directed axial force on the lead body.

3. The method of claim 1 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.

4. The method of claim 1 wherein deploying the fixation mechanism further includes inflating the fixation mechanism with a deployment fluid.

5. The method of claim 1 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.

6. The method of claim 1 wherein the method further includes fixing the fixation mechanism to the heart through cellular attachment.

7. The method of claim 1 further comprising allowing the anchor mechanism or the tether to dissolve.

8. The method of claim 1 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.

9. The method of claim 1 wherein the method further includes:

coupling the proximal end of the lead body to a pulse generator; and

delivering electrical signals from the pulse generator to an electrode positioned on the lead body.

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

delivering an anchor mechanism coupled to a distal end of a tether to an epicardial surface;

threading a lead body having a proximal end, a distal end, a lumen extending through the lead body, and a fixation mechanism positioned at the distal end over a proximal end of the tether;

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

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

coupling the lead body to the anchor mechanism and the tether.

11. The method of claim 10 wherein deploying the fixation mechanism includes exerting a proximally directed axial force on the lead body.

12. The method of claim 10 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.

13. The method of claim 10 wherein deploying the fixation mechanism further includes inflating the fixation mechanism with a deployment fluid.

14. The method of claim 10 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.

15. The method of claim 10 wherein the method further includes fixing the fixation mechanism to the heart through cellular attachment.

16. The method of claim 10 further comprising allowing the anchor mechanism or the tether to dissolve.

17. The method of claim 10 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.

18. The method of claim 10 wherein the method further includes:

coupling the proximal end of the lead body to a pulse generator and

delivering electrical signals from the generator to an electrode positioned on the lead body.