Absorbable myocardial lead fixation system

• US 20050119718A1
• Filed: 10/22/2004
• Published: 06/02/2005
• 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 7,499,757 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

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:

a lead body;

an anchor mechanism for engaging the heart, said anchor mechanism coupled to the lead body and formed of a bioabsorbable or biodegradable polymer; 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.

2. The system of claim 1 wherein the anchor mechanism has a dissolution time greater than a time required to form scar tissue 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 polymer that are released in order to modify the healing response to the lead placement.

6. The system of claim 1 wherein the anchor mechanism further comprises a tether coupled at a distal end to an anchor.

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

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

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

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

11. 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.

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

13. The system of claim 11 wherein the surface feature is a rough surface finish on the electrode.

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

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

16. The system of claim 14 wherein the dissolvable coating has a smooth outer surface.

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

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

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:

a lead body; and

an anchor mechanism for engaging the heart, said anchor mechanism coupled to the lead body and formed of a bioabsorbable or biodegradable polymer.

20. The system of claim 19 wherein the anchor mechanism is made from a material selected from the group including:

Polyglycolide (“

PGA”

), Polylactide (“

PLA”

), Polydioxanone (“

PDA”

), and Polylactide-co-glycolide.

21. The system of claim 19 wherein the anchor mechanism further comprises a tether coupled at a distal end to an anchor.

22. The system of claim 21 wherein either or both of the anchor and tether are formed of a bioabsorbable or biodegradable polymer.

23. The system of claim 19 wherein the anchor mechanism has a dissolution time greater than a time required to form scar tissue around a portion of the lead body located within the myocardium.

24. The system of claim 19 wherein the anchor mechanism further includes biologic or pharmacological agents in the polymer that are released in order to modify the healing response to the lead placement.

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

a lead body;

an anchor mechanism coupled to the lead body for engaging the 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.

26. A method for attaching a myocardial lead within the myocardium with an anchor mechanism, the method comprising:

inserting a dissolvable anchor mechanism coupled to a lead having a porous surface feature into the myocardium;

allowing tissue to invade the porous surface feature; and

allowing the anchor mechanism to dissolve.

27. The method of claim 26 wherein inserting the anchor mechanism includes inserting an anchor mechanism including a biologic or pharmacologic agent and the method further includes allowing the release of the agent as the anchor mechanism dissolves.

28. The method of claim 26 wherein allowing the anchor mechanism to dissolve further includes allowing the anchor mechanism to dissolve after sufficient tissue invasion has occurred to fix the lead in place.

29. The method of claim 26 wherein inserting the anchor mechanism further includes inserting an anchor mechanism having a dissolvable outer coating and the method further includes allowing the coating to dissolve to reveal the anchor mechanism.