HELICAL FIXATION MEMBER WITH CHEMICAL ELUTION CAPABILITIES

• US 20100004723A1
• Filed: 06/23/2009
• Published: 01/07/2010
• Est. Priority Date: 07/03/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Foster, Arthur J., Miller, Matthew J.
• Granted Patent: US 8,275,468 B2
• Time in Patent Office: Days
• US Class Current: 607/127
• CPC Class Codes: A61N 1/0575 with drug delivery

Abstract

The lead includes a helical fixation member coupled to the distal end of the lead body. The helical fixation member has at least one internal reservoir and a plurality of elution ports in fluid communication with the internal reservoir. A therapeutic agent composition is disposed within the internal reservoir. Additionally, the helical fixation member includes a sealed distal end to prevent coring of the cardiac tissue.

Claims

1. A medical electrical lead for use in a cardiac rhythm management system and adapted to be implanted within a patient'"'"'s heart, the lead comprising:

a lead body including a proximal end configured to be coupled to a pulse generator and a distal end adapted to be implanted at an implantation site within a patient'"'"'s heart;

at least one conductor extending within the lead body from the proximal end to the distal end;

at least one electrode located along the lead body and operatively coupled to the at least one conductor;

a helical fixation member coupled to the distal end of the lead body, the helical fixation member comprising at least a first internal reservoir, a plurality of elution ports located along a length of the helical fixation member in fluid communication with the first internal reservoir, and a sealed distal tip that is not in communication with the plurality of elution ports, wherein the tip is configured to engage cardiac tissue at the implantation site; and

a first therapeutic agent composition comprising at least one therapeutic agent and a carrier contained within the first internal reservoir.

2. The lead according to claim 1, wherein the carrier comprises a gel.

3. The medical electrical lead according to claim 1, wherein the therapeutic agent comprises at least one steroid selected from the group consisting of dexamethasone, betamethasone, paramethasone, beclomethasone, clobetasol, trimcinolone, prednisone, prednisolone and derivatives thereof.

4. The medical electrical lead according to claim 1, wherein the therapeutic agent comprises dexamethasone or derivatives thereof.

5. The medical electrical lead according to claim 1, wherein the therapeutic agent comprises beclomethasone or derivatives thereof.

6. The medical electrical lead according to claim 1, wherein the helical fixation member comprises a second internal reservoir comprising a second therapeutic agent composition disposed therein, wherein a first plurality of elution ports are in fluid communication with the first internal reservoir and a second plurality of elution ports are in fluid communication with the second internal reservoir.

7. The medical electrical lead according to claim 6, wherein the first therapeutic agent composition comprises a steroid disposed in a first carrier selected for rapid release of the steroid and the second therapeutic agent composition comprises the steroid disposed in a second carrier selected for extended release of the steroid.

8. The medical electrical lead according to claim 6, wherein the first therapeutic agent composition comprises a first steroid and the second therapeutic agent composition comprises a second steroid.

9. The medical electrical lead according to claim 6, wherein the first plurality of elution ports comprises a greater number or elution ports than the second plurality of elution ports.

10. The medical electrical lead according to claim 1, wherein the helical fixation member is electrically active.

11. A medical electrical lead for use with a cardiac rhythm management system and adapted to be implanted in a patient'"'"'s heart, the lead comprising:

a lead body including a proximal end configured to be coupled to a pulse generator and a distal end adapted to be implanted at an implantation site within a patient'"'"'s heart;

at least one conductor extending within the lead body from the proximal end to the distal end;

at least one electrode located along the lead body and operatively coupled to the at least one conductor;

a helical fixation member coupled to the distal end of the lead body, the helical fixation member comprising a first internal reservoir having a first therapeutic agent composition disposed therein and a second internal reservoir having a second therapeutic agent composition disposed therein, a plurality of elution portions located along a length of the helical fixation member comprising a first plurality of elution ports in fluid communication with the first internal reservoir and a second plurality of elution ports in fluid communication with the second internal reservoir.

12. The medical electrical lead according to claim 11, wherein the helical fixation member comprises a sealed distal tip configured to engage cardiac tissue.

13. The medical electrical lead according to claim 11, wherein the helical fixation member is operatively coupled to at least one conductor and is electrically active.

14. The medical electrical lead according to claim 11, wherein the first therapeutic agent composition comprises a steroid disposed in a first carrier selected for rapid release of the steroid and the second therapeutic agent composition comprises the steroid disposed in a second carrier selected for extended release of the steroid.

15. The medical electrical lead according to claim 11, wherein the first therapeutic agent composition comprises a first steroid disposed in a first carrier to provide an initial burst of the first steroid at the implantation site and the second therapeutic agent composition comprises a second steroid disposed in a second carrier to provide for extended release of the second steroid.

16. The medical electrical lead according to claim 11, wherein the first therapeutic agent composition comprises a first steroid and the second therapeutic agent comprises a second steroid.

17. The medical electrical lead according to claim 11, wherein the first internal reservoir is located in a distal region of the helical fixation member and the second internal reservoir is located in a proximal region of the helical fixation member.

18. The medical electrical lead according to claim 11, further comprising a physical barrier extending along a length of the helical fixation member separating the first internal reservoir from the second internal reservoir such that the first and second internal reservoirs are parallel to one another.

19. The medical electrical lead according to claim 11, wherein the first plurality of elution ports differ in size, shape and/or number from the second plurality of elution ports.

20. The medical electrical lead according to claim 11, wherein the first plurality of elution ports are greater in number than the second plurality of elution ports.

21. The medical electrical lead according to claim 11, wherein the helical fixation member comprises a third internal reservoir comprising a third therapeutic agent composition disposed therein, wherein a third plurality of elution ports is in fluid communication with the third internal reservoir.