Implantable stimulation lead having an advanceable therapeutic drug delivery system

• US 5,833,715 A
• Filed: 06/27/1995
• Issued: 11/10/1998
• Est. Priority Date: 09/03/1992
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Moaddeb, Shahram, Vachon, David J.
• Primary Examiner(s): Bahr, Jennifer
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US08/495,767
• Time in Patent Office: 1,232 Days
• Field of Search: 128/642, 607/119-128
• US Class Current: 607/120
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0575 with drug delivery

Abstract

A pacing lead having a stylet introduced anti-inflammatory drug delivery element advanceable from the distal tip electrode. The element is preferably formed as a moldable biocompatible composite material. The element has a biocompatible matrix material which may be combined with drugs and therapeutic agents to deliver the drugs and agents by co-dissolution or diffusion to the point of either passive or active fixation. The drug delivery element may be rigid and serve to center an active fixation mechanism, preferably a helix, which penetrates the myocardium.

Claims

1. An implantable endocardial pacing lead for use with a cardiac pacemaker, the pacing lead including an electrical conductor encased in an insulation sheath extending from a proximal end to a distal end of the pacing lead and an connector affixed to said proximal end of said conductor, said pacing lead further comprising:

an active fixation electrode assembly affixed to said distal end of said conductor, said active fixation electrode assembly being capable of axial advancement relative to the distal end of said pacing lead to penetrate myocardial tissue, said active fixation electrode assembly having an active fixation electrode; and

stabilizing means extending beyond the active fixation electrode and axially advanceable simultaneously with the advancing of said active fixation electrode assembly, for stabilizing the distal end of the pacing lead at a desired location in the myocardial tissue as the electrode penetrates into the myocardial tissue, wherein said stabilizing means comprises a biocompatible matrix material.

2. The pacing lead of claim 1, wherein the active fixation electrode comprises:

a helical electrode adapted to be rotated into the myocardium to thereby provide the active fixation.

3. The pacing lead of claim 2, wherein the stabilizing means comprises:

means being of sufficient rigidity to penetrate the myocardium.

4. An implantable endocardial pacing lead for use with a cardiac pacemaker, the pacing lead including an electrical conductor encased in an insulation sheath extending from a proximal end to a distal end of the pacing lead and an electrical connector affixed to said proximal end of said conductor, said pacing lead further comprising:

an active fixation electrode assembly affixed to said distal end of said conductor, said active fixation electrode assembly being capable of axial advancement relative to the distal end of said pacing lead to penetrate myocardial tissue, said active fixation electrode assembly having an active fixation electrode; and

stabilizing means extending beyond the active fixation electrode and axially advanceable simultaneously with the advancing of said active fixation electrode assembly, for stabilizing the distal end of the pacing lead as the electrode penetrates into the myocardial tissue, wherein said stabilizing means comprises therapeutic delivery means.

5. The pacing lead of claim 4, wherein the active fixation electrode comprises:

a helical electrode adapted to be rotated into the myocardium to thereby provide the active fixation.

6. The pacing lead of claim 4, wherein the stabilizing means further comprises:

means being of sufficient rigidity to penetrate the myocardium.

7. The pacing lead of claim 4, wherein the stabilizing means further comprises:

a rigid pin.

8. The pacing lead of claim 4, wherein the therapeutic delivery means further comprises:

a biocompatible matrix material.

9. The pacing lead of claim 8, wherein said biocompatible matrix material is a material selected from the group consisting of polylactic acid, polyglycolic acid, polylactic/glycolic acid copolymers, polyorthoesters, polyesters, polyurethanes, polyanhydrides, polyamino acids and ion exchange resins.

10. The pacing lead of claim 9, wherein said ion exchange resin is sulfonated polytetrafluoroethylene.

11. The pacing lead of claim 8, wherein said biocompatible matrix material is a material selected from the group of proteins consisting of collagen, gelatin, and albumin.

12. The pacing lead of claim 4, wherein said therapeutic delivery means comprises a therapeutic eluting reservoir.

13. The pacing lead of claim 12, wherein said therapeutic eluting reservoir contains a therapeutic solution having a temperature dependent flow property, said therapeutic solution for preventing inflammation of said myocardial tissue.

14. The pacing lead of claim 13, wherein said therapeutic solution includes dexamethasone sodium phosphate.

15. The pacing lead of claim 14, wherein said therapeutic delivery means further comprises means for sealing said at least one therapeutic eluting opening.

16. The pacing lead of claim 13, wherein said therapeutic solution includes Polysorbate 80.

17. The pacing lead of claim 4, wherein said therapeutic delivery means has a plurality of therapeutic eluting openings.

18. The pacing lead of claim 17, wherein said therapeutic eluting openings comprise ports.

19. The pacing lead of claim 17, wherein said therapeutic eluting openings comprise vertical slots.

20. The pacing lead of claim 17, wherein said therapeutic eluting openings comprise horizontal slots.

21. The pacing lead of claim 17, wherein said therapeutic delivery means further comprises means for sealing said therapeutic eluting openings.

22. The pacing lead of claim 21, wherein said means for sealing comprises a bioabsorbable material.

23. The pacing lead of claim 17, wherein said therapeutic delivery means further comprises a therapeutic eluting reservoir in fluid communication with said plurality of therapeutic eluting openings.

24. The pacing lead of claim 4, wherein said stabilizing means further comprises an electrically conductive material and wherein said stabilizing means is electrically connected to said electrical conductor.

25. The pacing lead of claim 4, wherein said therapeutic delivery means further comprises a therapeutic agent.

26. The pacing lead of claim 25, wherein said therapeutic agent is selected from the group consisting of fluoro-trihydroxyl-methyl pregna diene/dione, fluoromethylprednisolone, sodium phosphate, a sodium salt of methoxymethyl-napthalene-acetic-acid, sodium, and a sodium salt of isobutylphenyl-propionic acid.

27. The pacing lead of claim 26, wherein said therapeutic delivery means includes a mixture of at least two different forms of said therapeutic agent which have different rates of dissolution or diffusion.

28. The pacing lead of claim 25, wherein said therapy delivery means is a composition wherein said therapeutic agent constitutes between about 0.01% to 50% by weight of the therapy delivery means and said composition has a structural rigidity in the range of between about 50A Shore hardness and 95D Shore hardness.

29. The pacing lead of claim 4, wherein said therapeutic delivery means has at least one therapeutic eluting opening and said therapeutic delivery means further comprises a therapeutic eluting reservoir in fluid communication with said at least one therapeutic eluting opening.

30. The pacing lead of claim 29, wherein said at least one therapeutic eluting opening comprises at least one port.

31. The pacing lead of claim 29, wherein said at least one therapeutic eluting opening comprises at least one vertical slot.

32. The pacing lead of claim 29, wherein said at least one therapeutic eluting opening comprises at least one horizontal slot.

33. An implantable endocardial pacing lead for use with a cardiac pacemaker, the pacing lead including an electrical conductor encased in an insulation sheath extending from a proximal end to a distal end of the pacing lead and an electrical connector affixed to said proximal end of said conductor, said pacing lead further comprising:

an active fixation electrode assembly affixed to said distal end of said conductor, said active fixation electrode assembly being capable of axial advancement relative to the distal end of said pacing lead to penetrate myocardial tissue, said active fixation electrode assembly having an active fixation electrode in the form of a rigid helix rotatable into myocardial tissue; and

stabilizing means extending beyond the active fixation electrode and axially advanceable simultaneously with the advancing of said active fixation electrode assembly, for providing an axis about which the rigid helix is rotatable thereby stabilizing the distal end of the pacing lead as the active fixation electrode penetrates and then rotates about said axis into the myocardial tissue, wherein said stabilizing means comprises therapeutic delivery means.