ELECTRODE LEAD SYSTEM

• US 20110160827A1
• Filed: 05/01/2009
• Published: 06/30/2011
• Est. Priority Date: 05/02/2008
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Herbert, Timothy P., Christopherson, Mark A., Testerman, Roy L., Bonde, Eric H.
• Application Number:
  US12/990,705
• Publication Number:
  US 20110160827A1
• Time in Patent Office: Days
• US Class Current: 607/118
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An electrode lead assembly includes a cuff electrode, a first lead portion and an anchor with the first lead portion having a length and a shape configured to provide strain relief on a nerve, on the cuff electrode, or on the first lead portion.

Claims

1. A lead system comprising:

a cuff electrode;

a first lead portion extending from the cuff electrode and having a generally serpentine configuration;

a second lead portion having a generally serpentine configuration and having a length substantially greater than a length of the first lead portion;

a first anchor interposed between the first lead portion and the second lead portion and configured to be secured relative to a non-nerve body structure; and

a connector extending proximally from the second lead portion and configured to electrically connect to an implantable pulse generator,

wherein the first lead portion has a length substantially greater than a distance between a nerve, onto which the cuff electrode is attached, and the non-nerve body structure onto which the first anchor is secured such that at least a portion of the first lead portion retains the generally serpentine configuration.

2. The lead system of claim 1 wherein the generally serpentine configuration of the respective first and second lead portions comprises a generally sinusoidal pattern.

3. The lead system of claim 1 wherein the second lead portion has a length about seven times the length of the first lead portion.

4. The lead system of claim 1 and further comprising a second anchor connected to the second lead portion and interposed between the anchor and the connector, wherein the second anchor is configured to be secured relative to a second non-nerve bodily structure.

5. The lead system of claim 1, wherein the length of the first lead portion corresponds to an arcuate length that includes the length of the curved portion of the generally serpentine configuration.

6. The lead system of claim 1, wherein the cuff electrode comprises:

an elongate cuff body including;

a base; and

a pair of resilient arcuate-shaped flange members and including a second flange member and a third flange member, the respective flange members each including a proximal portion that extends from the base outwardly and away from the other respective proximal portion and a distal portion that extends toward the other respective distal portion, wherein the base and the two flange members define a lumen and wherein the distal portions define a substantially re-closable opening, and wherein both the flange members extend a length of the cuff body;

a row of three generally rigid electrode elements embedded within the cuff body and spaced apart from each other along the length of the cuff body.

7. The lead system of claim 6, wherein each electrode element includes:

a generally arcuate first portion extending along an inner surface of at least one of the respective flange members to be exposed at the lumen, wherein the exposed first portion of the electrode element is located generally opposite the substantially re-closable opening of the cuff body; and

a generally straight second portion extending into the base and away from the first portion at a generally obtuse angle relative to the first portion.

8. The electrode assembly of claim 1, further comprising:

a first flange member including a first end secured to an outer surface of the second flange member and extending from the secured first end to overlap, and be in releasable contact with, a portion of the second flange member, the substantially re-closable opening, and the third flange member, wherein the first flange member terminates in a second end at a location over the third flange member,

wherein the second end of the first flange member is located generally opposite the substantially re-closable opening of the cuff body.

9. The electrode assembly of claim 6 wherein, in a fully engaged configuration of the electrode assembly, the first flange member is slidably movable relative to, and in releasable contact with, the second flange member such that at least a portion of the first flange member extends across and covers the substantially re-closable opening.

10. A method of delivering a lead assembly to treat sleep apnea, the method comprising:

providing a lead assembly including a cuff electrode, a first lead portion with a generally serpentine configuration, an anchor, a second lead portion with a generally serpentine configuration, and a connector, wherein a length of the first lead portion is substantially greater than a distance between a hypoglossal nerve and a non-nerve bodily structure adjacent the nerve;

releasably securing the cuff electrode about the hypoglossal nerve;

maneuvering and arranging the first lead portion to extend proximally from the cuff electrode toward the non-nerve bodily structure;

securing the anchor to the non-nerve bodily structure adjacent the target nerve while maintaining at least a portion of the first lead portion in a generally serpentine configuration as the first lead portion extends between the cuff electrode and the anchor; and

maneuvering and arranging the second lead portion to extend proximally from the anchor toward an implantable pulse generator.

11. The method of claim 10, comprising:

arranging the generally serpentine configuration of the respective first and second lead portions to define a generally sinusoidal pattern.

12. The method of claim 10, comprising:

arranging the second lead portion to have a length about seven times the length of the first lead portion.

13. The method of claim 10 and further comprising:

arranging the lead assembly to include a second anchor connected to the second lead portion and interposed between the anchor and the connector; and

securing the second anchor to a second non-nerve bodily structure located between the non-nerve bodily structure and the pectoral region.

14. The method of claim 10, comprising:

arranging the secured cuff electrode and the secured anchor in substantially the same vertical plane such that a majority of the first lead portion extends generally perpendicular to the vertical plane.