Cardiac lead with steroid eluting ring

• US 7,187,980 B2
• Filed: 10/28/2002
• Issued: 03/06/2007
• Est. Priority Date: 11/09/2001
• Status: Active Grant

• Current Assignee: Oscor Inc
• Original Assignee: Oscor Inc
• Inventors: Osypka, Thomas P., van den Nieuwenhof, Ronald
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US10/282,203
• Publication Number:
  US 20030093136A1
• Time in Patent Office: 1,590 Days
• Field of Search: 607/120, 607126-128, 607/122
• US Class Current: 607/120
• CPC Class Codes: A61N 1/0568 with drug delivery
• 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 cardiac lead is disclosed which includes an elongated lead body having opposed proximal and distal ends, a tip electrode operatively associated with the distal end of the elongated lead body, a connector operatively associated with the proximal end of the elongated lead body and electrically connected to the tip electrode, and a cylindrical eluting ring disposed proximate the tip electrode and formed from a compound including an elastomer and about 15% to 25% by weight medicament.

Claims

1. A cardiac lead comprising:

a) an elongated lead body having opposed proximal and distal ends;

b) a tip electrode operatively associated with the distal end of the elongated lead body and having an exposed distal end surface and a proximal reception bore;

c) a connector operatively associated with the proximal end of the elongated lead body and electrically connected to the tip electrode by a conductor coil received within the proximal reception bore of the tip electrode; and

d) a cylindrical eluting ring disposed at the distal end of the lead body proximate to the exposed distal end surface of the tip electrode, having an axial length of about 1 mm to 2 mm, surrounding the tip electrode and formed from a compound including silicone and about 15% to 25% by weight medicament, the eluting ring being dimensioned and configured in such a manner so as to control the rate at which the medicament is eluted from the silicone, and wherein the cylindrical eluting ring has;

(i) an exposed outer diametrical eluting surface; and

(ii) an exposed distal annular eluting surface in close proximity to the exposed distal end surface of the tip electrode for treating surrounding cardiac tissue over time, and wherein the axial distance between the exposed distal annular eluting surface of the eluting ring and the exposed distal end surface of the tip electrode is substantially less than the axial length of the eluting ring.

2. A cardiac lead as recited in claim 1, wherein the lead is adapted for active fixation and includes a retractable fixation screw operatively associated with a distal end portion of the lead body.

3. A cardiac lead as recited in claim 1, wherein the lead is adapted for passive fixation and includes a plurality of flexible tines associated with a distal end portion of the lead body.

4. A cardiac lead as recited in claim 1, wherein the lead is adapted for bipolar stimulation and includes a ring electrode spaced proximally from the tip electrode and electrically connected to the connector.

5. A cardiac lead as recited in claim 1, wherein the compound from which the eluting ring is formed includes about 15% to 25% by weight steroid.

6. A cardiac lead as recited in claim 1, wherein the compound from which the eluting ring is formed includes about 15% to 25% by weight dexamethasone sodium phosphate.

7. A cardiac lead as recited in claim 1, wherein the compound from which the eluting ring is formed includes about 15% to 25% by weight dexamethasone sodium acetate.

8. A cardiac lead as recited in claim 1, wherein the eluting ring has a durometer of about 65 to 90 Shore A.

9. A cardiac lead as recited in claim 1, wherein the conductor comprises a conductor coil which extends through the lead body for electrically connecting the tip electrode to the connector.

10. A cardiac lead configured for active fixation comprising:

a) an elongated lead body having opposed proximal and distal ends;

b) an annular tip electrode operatively associated with the distal end of the elongated lead body and having an exposed distal end surface and a proximal reception bore;

c) a retractable fixation screw operatively associated with a distal portion of the lead body;

d) a connector operatively associated with the proximal end of the elongated lead body and electrically connected to the tip electrode by a conductor coil received within the proximal reception bore of the tip electrode; and

e) a cylindrical eluting ring disposed at the distal end of the lead body proximate to the exposed distal end surface of the tip electrode, having an axial length of about 1 mm to 2 mm, surrounding the tip electrode and formed from a compound including silicone and about 15% to 25% by weight medicament, the eluting ring being dimensioned and configured in such a manner so as to control the rate at which the medicament is eluted from the silicone, and wherein the cylindrical eluting ring has;

(i) an exposed outer diametrical eluting surface; and

(ii) an exposed distal annular eluting surface in close proximity to the exposed distal end surface of the tip electrode, for treating surrounding cardiac tissue over time, and wherein the axial distance between the exposed distal annular eluting surface of the eluting ring and the exposed distal end surface of the tip electrode is substantially less than the axial length of the eluting ring.

11. A cardiac lead as recited in claim 10, wherein the lead is adapted for bipolar stimulation and includes a ring electrode spaced from the tip electrode and electrically connected to the connector.

12. A cardiac lead as recited in claim 11, wherein the conductor comprises at least one multifilar conductor coil extending through the lead body for electrically connecting the tip electrode and the ring electrode to the connector.

13. A cardiac lead as recited in claim 10, wherein the compound from which the eluting ring is formed includes about 15% to 25% by weight dexamethasone sodium phosphate.

14. A cardiac lead as recited in claim 10, wherein the compound from which the eluting ring is formed includes about 15% to 25% by weight dexamethasone sodium acetate.

15. A cardiac lead as recited in claim 10, wherein the eluting ring has a durometer of about 65 to 90 Shore A.

16. A cardiac lead as recited in claim 10, wherein the conductor comprises a conductor coil which extends through the lead body for electrically connecting the tip electrode and the connector.

17. A cardiac lead configured for bipolar stimulation comprising:

a) an elongated lead body having opposed proximal and distal ends;

b) a cathodic tip electrode operatively associated with the distal end of the elongated lead body and having an exposed distal end surface and a proximal reception bore;

c) an anodic ring electrode spaced proximally from the tip electrode;

d) a connector operatively associated with the proximal end of the elongated lead body and electrically connected to the tip electrode by a conductor coil received within the proximal reception bore of the tip electrode and electrically connected to the ring electrode; and

e) a cylindrical eluting ring disposed at the distal end of the lead body, having an axial length of about 1 mm to 2 mm, disposed proximate to the exposed distal end surface of the tip electrode and formed from a compound including silicone and about 15% to 25% by weight medicament, the eluting ring being dimensioned and configured in such a manner so as to control the rate at which the medicament is eluted from the silicone, and wherein the cylindrical eluting ring has;

(i) an exposed outer diametrical eluting surface; and

(ii) an exposed distal annular eluting surface in close proximity to the exposed distal end surface of the tip electrode, for treating surrounding cardiac tissue over time, and wherein the axial distance between the exposed distal annular eluting surface of the eluting ring and the exposed distal end surface of the tip electrode is substantially less than the axial length of the eluting ring.

18. A cardiac lead as recited in claim 17, wherein the lead is adapted for active fixation and includes a retractable fixation screw operatively associated with a distal end portion of the lead body.

19. A cardiac lead as recited in claim 17, wherein the lead is adapted for passive fixation and includes a plurality of flexible tines associated with a distal end portion of the lead body.

20. A cardiac lead as recited in claim 17, wherein the compound from which the eluting ring is formed includes about 15% to 25% by weight dexamethasone sodium phosphate.

21. A cardiac lead as recited in claim 17, wherein the compound from which the eluting ring is formed includes about 15% to 25% by weight dexamethasone sodium acetate.

22. A cardiac lead as recited in claim 17, wherein the eluting ring has a durometer of about 65 to 90 Shore A.

23. A cardiac lead as recited in claim 17, wherein the connector is an IS-1 type connector.

24. A cardiac lead as recited in claim 17, wherein the conductor comprises at least one multifilar conductor coil extending through the lead body for electrically connecting the tip electrode and the ring electrode to the connector.

25. A cardiac lead as recited in claim 17, further comprising at least one defibrillation coil spaced proximally from the ring electrode.

26. A cardiac lead as recited in claim 25, further comprising at least one additional connector operatively associated with the proximal end of the elongated lead body and electrically connected to the at least one defibrillation coil.

27. A cardiac lead as recited in claim 26, wherein the connector is a DF-1 type connector.