DUAL SPIRAL LEAD CONFIGURATIONS

• US 20080183254A1
• Filed: 01/30/2007
• Published: 07/31/2008
• Est. Priority Date: 01/30/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Koop, Brendan, Westlund, Randy W., Bly, Mark J., Caparso, Anthony V., Heil, Ronald W.
• Granted Patent: US 7,949,409 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

A medical electrical lead for transvascularly stimulating a nerve, muscle or other tissue from an adjacent vessel is described. The lead includes a bifurcated distal portion including a first elongate member forming a first spiral and a second elongate member forming a second spiral. The spirals can be in parallel or serial alignment with one another.

Claims

1. An intravascular lead adapted to be deployed to a stimulation site within a vessel adjacent a nerve to be stimulated, the lead comprising:

a lead body including a proximal end adapted to be connected to a pulse generator;

a bifurcated distal portion for securing and stabilizing the lead in the vessel, the distal portion comprising at least a first elongated member forming a first spiral and a second elongated member forming a second spiral, wherein the spirals are adapted to transition from a collapsed configuration for inserting the lead through a patient'"'"'s vasculature system to an expanded configuration, wherein the spirals frictionally engage at least one wall of the vessel in which the distal portion is deployed; and

one or more electrodes located on the distal portion, wherein at least one electrode is adapted to deliver an electrical pulse transvascularly to the nerve.

2. The intravascular lead according to claim 1, wherein the vessel is selected from the group consisting of an internal jugular vein, a superior vena cava, and a brachiocephalic vein, and wherein the nerve is the vagus nerve.

3. The intravascular lead according to claim 1, wherein the distal portion includes a generally straight portion occurring between the first spiral and the second spiral.

4. The intravascular lead according to claim 3, wherein the first spiral is in serial alignment with the second spiral.

5. The intravascular lead according to claim 3, wherein the distal portion comprises one or more electrodes located on the first spiral, the second spiral, the generally straight portion or a combination thereof.

6. The intravascular lead according to claim 1, wherein at least one spiral has an outer effective diameter that is about 2 percent to about 20 percent greater than an inner diameter of the vessel in which the distal portion is deployed.

7. The intravascular lead according to claim 1, wherein one or more electrodes are in close proximity to the nerve to be stimulated.

8. The intravascular lead according to claim 1, wherein a distance between one or more electrodes and the nerve to be stimulated is less than 2 mm.

9. The intravascular lead according to claim 1, wherein the first and second spirals are congruent, anti-parallel spirals having a same longitudinal axis forming a double helix.

10. The intravascular lead according to claim 1, wherein the distal portion comprises a superelastic material selected from the group consisting of Nitinol and MP35N.

11. The intravascular lead according to claim 1, wherein one or more electrodes are located on the distal portion such that they are aligned in parallel with the nerve to be stimulated.

12. The intravascular lead according to claim 1, further comprising a pull wire attached to a distal portion of the lead.

13. An intravascular lead adapted to be deployed to a stimulation site within a vessel adjacent a nerve to be stimulated, the lead comprising:

a conductive lead body including a proximal end adapted to be connected to a pulse generator; and

a distal portion comprising at least a first elongated member forming a first spiral and a second elongated member forming a second spiral, wherein each of the first and second spirals are adapted to secure and stabilize the distal portion within the vessel.

14. The intravascular lead according to claim 13, wherein the distal portion is bifurcated.

15. The intravascular lead according to claim 13, wherein the second elongated member is a super-elastic wire.

16. The intravascular lead according to claim 13, further comprising one or more electrodes adapted to deliver an electrical pulse transvascularly to the nerve to be stimulated.

17. The intravascular lead according to claim 16, wherein the electrodes are in parallel alignment with the nerve to be stimulated.

18. The intravascular lead according to claim 13, comprising a generally straight portion occurring between the first spiral and the second spiral.

19. The intravascular lead according to claim 13, wherein the first spiral is in serial alignment with the second spiral.

20. The intravascular lead according to claim 13, wherein the spirals are configured to expand and frictionally engage at least one vessel wall upon deployment in a vessel.

21. The intravascular lead according to claim 13, wherein the first and second spirals are congruent, anti-parallel spirals having a same longitudinal axis and form a double helix.

22. The intravascular lead according to claim 13, wherein the distal portion comprises a superelastic material selected from the group consisting of Nitinol and MP35N.

23. A method of providing a therapy to a nerve or muscle from an adjacent vessel, the method comprising:

providing an intravascular medical lead including a lead body having a proximal end connected to a pulse generator and a bifurcated distal portion comprising at least a first elongated member forming a first spiral and a second elongated member forming a second spiral;

transitioning the distal portion of the lead from an expanded configuration to a collapsed configuration;

delivering the distal portion of the lead to a stimulation site located within the adjacent vessel;

deploying the distal portion to an expanded configuration such that the distal portion secures and stabilizes the lead within the vessel; and

stimulating the adjacent vagus nerve.

24. The method according to claim 23, further comprising detecting an optimal stimulation threshold.

25. The method according to claim 23, further comprising rotating the lead body to orient at least one electrode located on at least one spiral towards the nerve or muscle to be stimulated.

26. (canceled)

27. (canceled)

28. (canceled)

29. (canceled)