Absorbable myocardial lead fixation system

• US 7,499,757 B2
• Filed: 10/22/2004
• Issued: 03/03/2009
• 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
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): LEE, YUN H
• Application Number:
  US10/971,577
• Publication Number:
  US 20050119718A1
• Time in Patent Office: 1,593 Days
• Field of Search: 607/120
• US Class Current: 607/120
• 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

A myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient'"'"'s heart. The system includes a lead body, an anchor mechanism formed of a bioabsorbable or biodegradable polymer for engaging a surface of the patient'"'"'s heart and a surface feature formed on a portion of the lead body for promoting formation of scar tissue around said portion of the lead body.

Claims

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

an anchor mechanism configured formed of a bioabsorbable or biodegradable polymer, the anchor mechanism configured to advance through myocardial tissue in a first orientation and configured to anchor against an epicardial surface in a second orientation;

a tether having a proximal end and a distal end, wherein the anchor mechanism is coupled to the distal end of the tether; and

a lead body having a proximal end, a distal end, a surface feature formed on a portion of the lead body for promoting formation of scar tissue around the portion, and a lumen extending through the lead body, wherein the lead body and the lumen are configured such that the lead body can be threaded over the proximal end of the tether and slideably advanced over the tether toward the anchor mechanism during implantation;

wherein the anchor mechanism and the tether are configured to couple to the lead body, thereby chronically retaining the distal end of the lead body in the heart after implantation.

2. The system of claim 1 wherein the anchor mechanism is configured to dissolve after scar tissue forms around a portion of the lead body located within the myocardium.

3. The system of claim 1 wherein the anchor mechanism is made from a material selected from the group including:

Polyglycolide (“

PGA”

), Polylactide (“

PLA”

), Polydioxanone (“

PDA”

), and Polylactide-co-glycolide.

4. The system of claim 1 wherein the anchor mechanism is made of a combination of bioabsorbable or biodegradable and non-bioabsorbable and non-biodegradable materials.

5. The system of claim 1 wherein the anchor mechanism further includes biologic or pharmacological agents in the bioabsorbable or biodegradable polymer that are released in order to modify the healing response to the lead placement.

6. The system of claim 1 wherein at least a portion of the tether is formed of a biodegradable or bioabsorbable polymer.

7. The system of claim 1 wherein the surface feature is a rough surface finish on the lead body.

8. The system of claim 1 wherein a portion of the lead body adapted to reside within the myocardium has the surface feature.

9. The system of claim 1 wherein substantially the entire lead body has the surface feature.

10. The system of claim 1 wherein the lead body further includes an electrode and wherein the surface feature is formed on at least a portion of the electrode.

11. The system of claim 10 wherein the surface feature is a conductive coating provided on the electrode.

12. The system of claim 10 wherein the surface feature is a rough surface finish on the electrode.

13. The system of claim 1 and further comprising a dissolvable coating applied over the surface feature.

14. The system of claim 13 wherein the dissolvable coating is water soluble.

15. The system of claim 13 wherein the dissolvable coating has a smooth outer surface.

16. The system of claim 1 and further comprising a dissolvable coating applied over the anchor mechanism, said coating having a trauma-reducing outer profile.

17. The system of claim 1 and further comprising a dissolvable coating applied over the anchor mechanism, said coating having a tissue-dissecting edge.

18. The myocardial lead attachment system of claim 1 wherein the first orientation of the anchor mechanism is substantially orthogonal to the second orientation of the anchor mechanism.

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

an anchor mechanism formed of a bioabsorbable or biodegradable polymer, the anchor mechanism configured to advance through myocardial tissue in a first orientation and configured to anchor against an epicardial surface in a second orientation;

a tether having a proximal end and a distal end, wherein the anchor mechanism is coupled to the distal end of the tether; and

a lead body having a proximal end, a distal end, and a lumen extending through the lead body, wherein the lead body and the lumen are configured such that the lead body can be threaded over the proximal end of the tether and slideably advanced over the tether toward the anchor mechanism during implantation;

wherein the anchor mechanism and the tether are configured to couple to the lead body, thereby chronically retaining the distal end of the lead body in the heart after implantation; and

wherein the anchor mechanism is configured to dissolve after scar tissue forms around a portion of the lead body located within the myocardium.

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

an anchor mechanism configured to advance through myocardial tissue in a first orientation and configured to anchor against an epicardial surface in a second orientation;

a tether having a proximal end and a distal end, wherein the anchor mechanism is coupled to the distal end of the tether; and

a lead body having a proximal end, a distal end, a surface feature formed on a portion of the lead body for promoting formation of scar tissue around the portion, and a lumen extending through the lead body, wherein the lead body and the lumen are configured such that the lead body can be threaded over the proximal end of the tether and slideably advanced over the tether toward the anchor mechanism during implantation;

wherein the anchor mechanism and the tether are configured to couple to the lead body, thereby chronically retaining the distal end of the lead body in the heart after implantation.

21. The myocardial lead attachment system of claim 20 wherein first orientation of the anchor mechanism is substantially orthogonal to the second orientation of the anchor mechanism.