Cardiac lead with steroid eluting ring

• US 20030093136A1
• Filed: 10/28/2002
• Published: 05/15/2003
• Est. Priority Date: 11/09/2001
• Status: Active Grant

• Current Assignee: Oscor Inc
• Original Assignee: Oscor Inc
• Inventors: Osypka, Thomas P., Nieuwenhof, Ronald van den
• Granted Patent: US 7,187,980 B2
• Time in Patent Office: Days
• 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) an annular tip electrode operatively associated with the distal end of the elongated lead body;

c) a connector operatively associated with the proximal end of the elongated lead body and electrically connected to the tip electrode; and

d) a cylindrical eluting ring surrounding the tip electrode and formed from a compound including an elastomer and about 15% to 25% by weight medicament.

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 silicone and about 15% to 25% by weight medicament.

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

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

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

9. A cardiac lead as recited in claim 1, wherein the eluting ring has an axial length of about 1 mm to 2 mm.

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

11. A cardiac lead as recited in claim 1, further comprising a conductor coil extending through the lead body for electrically connecting the tip electrode to the connector.

12. A cardiac lead configured for passive 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;

c) a plurality of flexible tines 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; and

e) a cylindrical eluting ring surrounding the tip electrode and formed from a compound including an elastomer and about 15% to 25% by weight medicament.

13. A cardiac lead as recited in claim 12, 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.

14. A cardiac lead as recited in claim 12, wherein the compound from which the eluting ring is formed includes silicone and about 15% to 25% by weight dexamethasone sodium phosphate.

15. A cardiac lead as recited in claim 12, wherein the compound from which the eluting ring is formed includes silicone and about 15% to 25% by weight dexamethasone sodium acetate.

16. A cardiac lead as recited in claim 12, wherein the eluting ring has an axial length of about 1 mm to 2 mm.

17. A cardiac lead as recited in claim 12, wherein the eluting ring has a durometer of about 65 to 90 Shore A.

18. A cardiac lead as recited in claim 12, further comprising a conductor coil extending through the lead body for electrically connecting the tip electrode and the connector.

19. A cardiac lead as recited in claim 13, further comprising at least one multifilar conductor coil extending through the lead body for electrically connecting the tip electrode and the ring electrode to the connector.

20. 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;

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; and

e) a cylindrical eluting ring surrounding the tip electrode and formed from a compound including an elastomer and about 15% to 25% by weight medicament.

21. A cardiac lead as recited in claim 20, wherein the lead is adapted for bipolar stimulation and includes a ring electrode spaced from the tip electrode and electrically connected to the connector.

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

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

24. A cardiac lead as recited in claim 20, wherein the eluting ring has an axial length of about 1 mm to 2 mm.

25. A cardiac lead as recited in claim 20, wherein the eluting ring has a durometer of about 65 to 90 Shore A.

26. A cardiac lead as recited in claim 20, further comprising a conductor coil extending through the lead body for electrically connecting the tip electrode and the connector.

27. A cardiac lead as recited in claim 21, further comprising at least one multifilar conductor coil extending through the lead body for electrically connecting the tip electrode and the ring electrode to the connector.

28. 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;

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 and the ring electrode; and

e) a cylindrical eluting ring disposed proximate to the tip electrode and formed from a compound including an elastomer and about 15% to 25% by weight medicament.

29. A cardiac lead as recited in claim 28, 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.

30. A cardiac lead as recited in claim 28, 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.

31. A cardiac lead as recited in claim 28, wherein the compound from which the eluting ring is formed includes silicone and about 15% to 25% by weight dexamethasone sodium phosphate.

32. A cardiac lead as recited in claim 28, wherein the compound from which the eluting ring is formed includes silicone and about 15% to 25% by weight dexamethasone sodium acetate.

33. A cardiac lead as recited in claim 28, wherein the eluting ring has an axial length of about 1 mm to 2 mm.

34. A cardiac lead as recited in claim 28, wherein the eluting ring has a durometer of about 65 to 90 Shore A.

35. A cardiac lead as recited in claim 28, wherein the connector is an IS-1 type connector.

36. A cardiac lead as recited in claim 28, further comprising at least one multifilar conductor coil extending through the lead body for electrically connecting the tip electrode and the ring electrode to the connector.

37. A cardiac lead as recited in claim 28, further comprising at least one defibrillation coil spaced proximally from the ring electrode.

38. A cardiac lead as recited in claim 37, 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.

39. A cardiac lead as recited in claim 38, wherein the connector is a DF-1 type connector.