High impedance drug eluting cardiac lead

• US 6,671,562 B2
• Filed: 10/28/2002
• Issued: 12/30/2003
• Est. Priority Date: 11/09/2001
• Status: Active Grant

• Current Assignee: Oscor Inc
• Original Assignee: Oscor Inc
• Inventors: van den Nieuwenhof, Ronald, Osypka, Thomas P.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US10/281,744
• Publication Number:
  US 20030093138A1
• Time in Patent Office: 428 Days
• Field of Search: 607/120-123, 607/126-128, 600/374-381
• 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 high impedance bipolar cardiac lead is disclosed that includes a lead body with a distal electrode assembly that includes an anodic ring electrode and a coaxially disposed cathodic tip electrode, wherein the anodic ring electrode and the cathodic tip electrode are separated from one another by a drug eluting insulating member.

Claims

1. A high impedance bipolar cardiac lead comprising:

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

b) a ring electrode operatively associated with the distal end of the lead body and defining an inner peripheral surface;

c) a tip electrode coaxially disposed within the ring electrode and defining an (outer peripheral surface such that an annular gap is formed between the inner peripheral surface of the ring electrode and the outer peripheral surface of the tip electrode;

d) a drug eluting insulating member disposed within the annular gap formed between the outer peripheral surface of the tip electrode and the inner peripheral surface of the ring electrode;

e) a connector operatively associated with the proximal end of the lead body and electrically connected to the ring and tip electrodes; and

f) conductor means extending through the lead body for delivering energy from the connector to the ring and tip electrodes to stimulate cardiac tissue.

2. A high impedance bipolar cardiac lead as recited in claim 1, wherein the ring electrode serves as an anode and the tip electrode serves as a cathode.

3. A high impedance bipolar cardiac lead as recited in claim 2, wherein the cathodic tip electrode has an exposed surface with a convex configuration.

4. A high impedance bipolar cardiac lead as recited in claim 3, wherein the cathodic tip electrode has an exposed surface area in the range of about between 0.50 mm² and 0.70 mm².

5. A high impedance bipolar cardiac lead as recited in claim 3, wherein the axial length of the ring electrode is about thrice the axial length of the tip electrode, and the axial length of the insulating member is about twice the axial length of the tip electrode.

6. A high impedance bipolar cardiac lead as recited in claim 1, wherein the insulating member is formed from a compound comprising an elastomer and a medicament.

7. A high impedance bipolar cardiac lead as recited in claim 6, wherein the compound from which the drug eluting insulating member is formed includes silicone and a steroid.

8. A high impedance bipolar cardiac lead as recited in claim 7, wherein the steroid forms about 15% to 20% of the weight of the compound from which the insulating member is formed.

9. A high impedance bipolar 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.

10. A high impedance bipolar cardiac lead as recited in claim 1, wherein the conductor means includes a multifilar conductor coil having a number of filaments associated with the ring electrode and a number of filaments associated with the tip electrode.

11. A high impedance bipolar cardiac lead as recited in claim 1, wherein the connector is defined by a bipolar IS-1 type connector.

12. A high impedance bipolar cardiac lead, comprising:

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

b) an anodic ring electrode operatively associated with the distal end of the lead body and defining an inner peripheral surface;

c) a cathodic tip electrode coaxially disposed within the ring electrode and defining an outer peripheral surface such that an annular gap is formed between the inner peripheral surface of the ring electrode and the outer peripheral surface of the tip electrode;

d) a drug eluting insulating member disposed within the annular gap formed between the outer peripheral surface of the cathodic tip electrode and the inner peripheral surface of the anodic ring electrode;

e) a connector operatively associated with the proximal end of the lead body and electrically connected to the ring and tip electrodes; and

f) conductor means extending through the lead to deliver electrical energy from the connector to the ring and tip electrodes to stimulate cardiac tissue.

13. A high impedance bipolar cardiac lead as recited in claim 12, wherein the cathodic tip electrode has an exposed surface with a convex configuration.

14. A high impedance bipolar cardiac lead as recited in claim 13, wherein the cathodic tip electrode has an exposed surface area in the range of about between 0.50 mm² and 0.70 mm².

15. A high impedance bipolar cardiac lead as recited in claim 12, wherein the drug eluting insulating member is formed from a compound comprising an elastomer and an anti-inflammatory drug.

16. A high impedance bipolar cardiac lead as recited in claim 15, wherein the compound from which the insulating member is formed includes silicone and a steroid.

17. A high impedance bipolar cardiac lead as recited in claim 16, wherein the steroid forms about 15% to 20% of the weight of the compound from which the insulating member is formed.

18. A high impedance bipolar cardiac lead as recited in claim 12, 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.

19. A high impedance bipolar cardiac lead as recited in claim 12, wherein the conductor means includes a multifilar conductor coil having a number of filaments associated with the anodic ring electrode and a number of filaments associated with the cathodic tip electrode.

20. A high impedance bipolar cardiac lead as recited in claim 12, wherein the connector is defined by a bipolar IS-1 type connector.

21. A high impedance bipolar cardiac lead as recited in claim 12, wherein the axial length of the ring electrode is about thrice the axial length of the tip electrode, and the axial length of the insulating member is about twice the axial length of the tip electrode.

22. A high impedance bipolar cardiac lead, comprising:

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

b) an electrode assembly operatively associated with the distal end of the lead body and including an anodic ring electrode defining a leading edge and a coaxially disposed cathodic tip electrode defining a leading surface, wherein the anodic ring electrode and the cathodic tip electrode are separated from one another by a drug eluting insulating member having a leading edge, and wherein the leading edges of the ring electrode and insulating member are coincident, and cooperate with the leading surface of the tip electrode to form an atraumatic pacing surface for the lead.

23. A high impedance bipolar cardiac lead as recited in claim 22, further comprising a connector operatively associated with the proximal end of the lead body and electrically connected to the ring and tip electrodes.

24. A high impedance bipolar cardiac lead as recited in claim 23, further comprising a multifilar conductor coil extending through the lead body to deliver electrical energy from the connector to the ring and tip electrodes to stimulate cardiac tissue.