Obstructive sleep apnea treatment devices, systems and methods

• US 8,639,354 B2
• Filed: 10/03/2011
• Issued: 01/28/2014
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Bolea, Stephen L., Hoegh, Thomas B., Persson, Bruce J., Atkinson, Robert E., Mazar, Scott T.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Sarcione, Jessica
• Application Number:
  US13/252,028
• Publication Number:
  US 20120022626A1
• Time in Patent Office: 848 Days
• Field of Search: 607/118, 607115-116, 607/42
• US Class Current: 607/118
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna

Abstract

In an embodiment, a lead system includes a cuff electrode to secure to a nerve, a first lead portion defining a longitudinal axis, and a second lead portion. An anchor may be between the first lead portion and the second lead portion to secure to non-nerve structure. A connector may extend from the second lead portion to connect to a pulse generator. Electrode elements are spaced apart along the cuff body. The cuff electrode may include a first resilient arcuate-shaped portion extending in a first circumferential direction and having a first arc length; and a second resilient arcuate-shaped portion integrally formed with the first arcuate-shaped portion, extending in a second circumferential direction, and having a second arm length greater that the first arc length. The second arcuate-shaped portion overlaps the first arcuate-shaped portion, The first and second arcuate-shaped portions define a lumen having a substantially re-closable opening.

Claims

1. A lead system comprising:

a cuff electrode configured to be secured to a nerve of a patient;

a first lead portion extending from the cuff electrode and having a distal end coupled to the cuff electrode, the first lead portion including a first flexible undulation disposed proximally of the distal end;

a second lead portion having a second flexible undulation, wherein an entirety of the second flexible undulation is disposed proximally of an entirety of the first flexible undulation;

an 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 cuff electrode comprises;

a first resilient arcuate-shaped portion extending in a first circumferential direction away from a longitudinal axis of the first lead portion and having a first arc length in the first circumferential direction when secured to the nerve, wherein a substantial entirety of the first resilient arcuate-shaped portion defines a first substantially constant cross-sectional dimension; and

a second resilient arcuate-shaped portion integrally formed of a one-piece construction with the first resilient arcuate-shaped portion, extending in a second circumferential direction away from the longitudinal axis of the first lead portion opposite the first circumferential direction, and having a second arc length in the second circumferential direction when secured to the nerve, wherein the second arc length is greater than the first arc length, wherein the second resilient arcuate-shaped portion overlaps the first resilient arcuate-shaped portion, wherein the first and second resilient arcuate-shaped portions define a lumen having a substantially re-closable opening, wherein the lumen includes an inner surface that transitions seamlessly from the first resilient arcuate-shaped portion to the second resilient arcuate-shaped portion, wherein the inner surface includes at least one electrode disposed therein, wherein a substantial entirety of the second resilient arcuate-shaped portion defines a second substantially constant cross-sectional dimension, and wherein the first substantially constant cross-sectional dimension is equal to the second substantially constant cross-sectional dimension.

2. The lead system of claim 1, wherein each of the first and second flexible undulations includes a plurality of flexible undulations forming a generally serpentine configuration having a sinusoidal pattern.

3. The lead system of claim 2, wherein a length of the first lead portion corresponds to an arcuate length that includes a length of a curved portion of the generally serpentine configuration.

4. The lead system of claim 1, wherein the first lead portion defines a longitudinal axis, and wherein the at least one electrode includes a plurality of electrode elements on the cuff electrode proximate the longitudinal axis of the first lead portion and spaced apart from each other along a length of the cuff electrode.

5. The lead system of claim 4, wherein each electrode element includes:

a first portion extending along the inner surface proximate at least one of the first and second resilient arcuate-shaped portions to be exposed at the lumen, wherein the exposed first portion of the electrode element is generally spaced from the substantially re-closable opening of the cuff body; and

a second portion extending into the at least one of the first and second resilient arcuate-shaped portions and away from the first portion at an angle relative to the first portion.

6. The lead system of claim 4, wherein one of the first and second resilient arcuate-shaped portions includes an extension configured to overlap and be in releasable contact with a portion of the other of the first and second resilient arcuate-shaped portions.

7. The lead system of claim 4, wherein, in a fully engaged configuration of the cuff electrode, one of the first and second resilient arcuate-shaped portions is movable relative to, and in releasable contact with, the other of the first and second resilient arcuate-shaped portions such that at least a portion of the one of the first and second resilient arcuate-shaped portions extends across and covers the substantially re-closable opening.

8. A method of delivering a lead assembly, the method comprising:

releasably securing a cuff electrode about a hypoglossal nerve,

the cuff electrode extending from a lead assembly comprising;

a first lead portion having a distal end coupled to the cuff electrode;

a second lead portion having a second plurality of flexible undulations, wherein an entirety of the second plurality of flexible undulations is disposed proximally of an entirety of the first lead portion; and

an anchor interposed between the first and second lead portions and configured to be secured relative to a digastric tendon;

wherein the cuff electrode comprises;

a first resilient arcuate-shaped portion extending in a first circumferential direction away from a longitudinal axis of the first lead portion and having a first arc length in the first circumferential direction, wherein a substantial entirety of the first resilient arcuate-shaped portion defines a first substantially constant cross-sectional dimension; and

a second resilient arcuate-shaped portion integrally formed of a one-piece construction with the first resilient arcuate-shaped portion, extending in a second circumferential direction away from the longitudinal axis of the first lead portion opposite the first circumferential direction, and having a second arc length in the second circumferential direction, wherein the second arc length is greater than the first arc length, wherein the second resilient arcuate-shaped portion overlaps the first resilient arcuate-shaped portion, and wherein the first and second resilient arcuate-shaped portions define a lumen having a substantially re-closable opening, wherein the lumen includes an inner surface that transitions seamlessly from the first resilient arcuate-shaped portion to the second resilient arcuate-shaped portion, wherein the inner surface includes at least one electrode disposed therein, wherein a substantial entirety of the second resilient arcuate-shaped portion defines a second substantially constant cross-sectional dimension, and wherein the first substantially constant cross-sectional dimension is equal to the second substantially constant cross-sectional dimension;

extending the first lead portion from the cuff electrode toward the digastric tendon;

securing the anchor to the digastric tendon adjacent the hypoglossal nerve; and

extending the second lead portion from the anchor toward an implantable pulse generator.

9. The method of claim 8, comprising:

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

10. The method of claim 8, wherein the first lead portion includes a first plurality of flexible undulations disposed proximally of the distal end.

11. The method of claim 10, wherein each of the first and second plurality of flexible undulations includes a generally serpentine configuration having a sinusoidal pattern.

12. The method of claim 8, wherein the cuff electrode is releasably secured about the hypoglossal nerve without sutures.

13. An electrode assembly comprising:

an elongate cuff body;

a lead body having a longitudinal axis and connected to the cuff body at an end of the cuff body; and

a plurality of electrode elements on the cuff body proximate the longitudinal axis of the lead body and spaced apart from each other along a length of the cuff body;

wherein the cuff body includes;

a first resilient arcuate-shaped portion extending in a first circumferential direction away from the longitudinal axis of the lead body and having a first arc length in the first circumferential direction, wherein a substantial entirety of the first resilient arcuate-shaped portion defines a first substantially constant cross-sectional dimension; and

a second resilient arcuate-shaped portion integrally formed of a one-piece construction with the first resilient arcuate-shaped portion, extending in a second circumferential direction away from the longitudinal axis of the lead body opposite the first circumferential direction, and having a second arc length in the second circumferential direction, wherein the second arc length is greater than the first arc length, wherein the second resilient arcuate-shaped portion overlaps the first resilient arcuate-shaped portion, and wherein the first and second resilient arcuate-shaped portions define a lumen having a substantially re-closable opening, wherein the lumen includes an inner surface that transitions seamlessly from the first resilient arcuate-shaped portion to the second resilient arcuate-shaped portion, wherein at least one of the plurality of electrodes is disposed in the inner surface, wherein a substantial entirety of the second resilient arcuate-shaped portion defines a second substantially constant cross-sectional dimension, and wherein the first substantially constant cross-sectional dimension is equal to the second substantially constant cross-sectional dimension.

14. The electrode assembly of claim 13, wherein each electrode element includes:

a first portion extending along the inner surface proximate at least one of the first and second resilient arcuate-shaped portions 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 second portion extending into the at least one of the first and second resilient arcuate-shaped portions and away from the first portion at an angle relative to the first portion.

15. The electrode assembly of claim 14, wherein the first portion of each electrode element includes an arcuate length of less than 180 degrees.

16. The electrode assembly of claim 14, wherein the generally arcuate shape of the first portion substantially matches a radius of curvature of the inner surface, wherein the first portion includes a hook portion extending generally away from the inner surface, and wherein the hook portion defines a recess configured to secure the respective electrode element relative to the cuff body.

17. The electrode assembly of claim 14, wherein the inner surface in the region of the first portion of the respective electrode elements is recessed relative to remaining portions of the inner surface.

18. The electrode assembly of claim 13, wherein the electrode assembly is operably connected to the lead body, wherein the lead body comprises:

a first lead portion having a distal end coupled to the elongate cuff body, the first lead portion including a first plurality of flexible undulations forming a generally serpentine configuration having a sinusoidal pattern, wherein the first plurality of flexible undulations is disposed proximally of the distal end;

a second lead portion having a second plurality of flexible undulations forming a generally serpentine configuration having a sinusoidal pattern, wherein an entirety of the second plurality of flexible undulations is disposed proximally of an entirety of the first plurality of flexible undulations; and

an anchor interposed between the first and second plurality of flexible undulations and configured to be secured relative to a non-nerve body structure.

19. The electrode assembly of claim 13, wherein a diameter of the lumen defined by the first and second resilient arcuate-shaped portions is expandable, in response to an increasing diameter of a nerve in the lumen.

20. A method of delivering an electrode assembly comprising:

releasably securing a cuff about a hypoglossal nerve, the cuff extending from a lead body, the lead body defining a longitudinal axis and comprising;

a first lead portion extending from the cuff and having a distal end coupled to the cuff;

a second lead portion; and

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

wherein a plurality of electrode elements are on the cuff proximate the longitudinal axis of the lead body and are spaced apart from each other along a length of the cuff;

wherein the cuff includes an elongate cuff body comprising;

a first arcuate-shaped portion having a first arc length and extending in a first circumferential direction away from the longitudinal axis of the lead body, wherein a substantial entirety of the first arcuate-shaped portion defines a first substantially constant cross-sectional dimension; and

a second arcuate-shaped portion having a second arc length greater than the first arc length and extending in a second circumferential direction away from the longitudinal axis of the lead body, wherein the second arcuate-shaped portion overlaps the first arcuate-shaped portion, wherein the first arcuate-shaped portion and the second arcuate-shaped portion are formed of a one-piece construction, and wherein the first and second arcuate-shaped portions define a lumen having a substantially re-closable opening, wherein the lumen includes an inner surface that transitions seamlessly from the first resilient arcuate-shaped portion to the second resilient arcuate-shaped portion, wherein at least one of the plurality of electrode elements is disposed in the inner surface, wherein a substantial entirety of the second arcuate-shaped portion defines a second substantially constant cross-sectional dimension, and wherein the first substantially constant cross-sectional dimension is equal to the second substantially constant cross-sectional dimension;

extending the first lead portion from the cuff toward the non-nerve body structure;

securing the anchor to the non-nerve body structure adjacent the hypoglossal nerve; and

extending the second lead portion from the anchor toward an implantable pulse generator.

21. The method of claim 20, wherein each electrode element includes:

a first portion extending along the inner surface proximate at least one of the first and second arcuate-shaped portions and arranged to be exposed at the lumen, wherein the exposed first portion is located generally opposite the opening of the cuff body; and

a second portion generally extending outward and away from a midpoint of the first portion into the at least one of the first and second arcuate-shaped portions.

22. The method of claim 21, wherein the second portion of the electrode elements comprises a generally U-shaped portion defining a recess between two spaced apart portions.

23. The method of claim 22, wherein the cuff body comprises a protrusion that extends into the recess of the generally U-shaped portion to embed the second portion within the cuff body.

24. The method of claim 20, wherein each of the first and second lead portions includes a plurality of flexible undulations.

25. The method of claim 20, wherein a diameter of the lumen defined by the elongate cuff body is expandable, in response to an increasing diameter of a nerve in the lumen.

26. The method of claim 20, wherein the cuff is releasably secured about the hypoglossal nerve without sutures.