SELF EXPANDING ELECTRODE CUFF

• US 20110147046A1
• Filed: 05/01/2009
• Published: 06/23/2011
• Est. Priority Date: 05/02/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Geroy, Jesse D., Christopherson, Mark A., Testerman, Roy L., Bonde, Eric H., Herbert, Timothy P.
• Granted Patent: US 9,227,053 B2
• Time in Patent Office: Days
• US Class Current: 174/126.1
• 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 is described. The lead assembly includes an expandable cuff electrode that includes a series of spaced apart electrode elements and a substantially re-closable opening.

Claims

1. An electrode assembly comprising:

an elongate cuff body including;

a base; and

a pair of resilient arcuate-shaped flange members that includes 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; and

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

2. The electrode assembly of claim 1 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.

3. The electrode assembly of claim 2 wherein the first portion of each electrode element has an arcuate length that generally corresponds to a 45 degree arc of the lumen.

4. The electrode assembly of claim 3 wherein the obtuse angle is about 130 degrees.

5. The electrode assembly of claim 2 wherein the generally arcuate shape of the first portion substantially matches a radius of curvature of the inner surface of second flange member, wherein the first portion includes a distal hook portion extending generally away from the inner surface of the second flange member, and wherein the distal hook portion defines a recess that receives a molded portion of the cuff body to secure the respective electrode element relative to the cuff body.

6. 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.

7. The electrode assembly of claim 6, wherein the first flange member has a length sufficient for the second end to extend distally beyond the third flange member and at least around a bottom wall of the base.

8. The electrode assembly of claim 6, wherein the first flange member has a length sufficient to wrap the first flange member at least two times about the circumference of the cuff body before the second end terminates at a position overlapping the first end of the first flange member.

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. The electrode assembly of claim 9 wherein a diameter of the lumen defined by the electrode cuff body is automatically expandable, in response to an increasing diameter of a nerve in the lumen, via rotation of the distal portion of the second flange member away from the distal portion of the third flange member and via slidable movement of the first flange member relative to the second flange member with the first flange member having a length sufficient to maintain overlap with the substantially re-closable opening and with a majority of a length of the second flange member during the automatic expansion.

11. The electrode assembly of claim 1, wherein the second flange member has a length substantially greater than a length of the third flange member such that the substantially re-closable opening laterally relative to, and not directly opposite, the base.

12. The electrode assembly of claim 1 wherein the proximal portions of the respective second and third flange members have a thickness substantially greater than the respective distal portions, and wherein the thickness of the proximal portion of the second flange member is substantially greater than the thickness of the third flange member such that the relative thicknesses of the second and third flange members are asymmetric.

13. The electrode assembly of claim 12 wherein each respective electrode element is positioned within the proximal portion of the second flange member generally at a region of maximum thickness of the second flange member.

14. The electrode assembly of claim 1 wherein the inner surface of the second flange member in the region of the first portion of the respective electrode elements is recessed relative to remaining portions of the inner surface of the second flange member.

15. The electrode assembly of claim 14 wherein the generally straight second portion extends generally parallel to a cross-sectional longitudinal axis of the base of the cuff body, wherein each electrode element further comprises a generally straight third portion extending within the base of the cuff body and outwardly from the second portion in a generally opposite direction from the first portion, and wherein the third portion is generally perpendicular to the second portion.

16. An electrode assembly comprising:

an elongate cuff body including;

a base; and

a pair of resilient arcuate-shaped flange members 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 at least partially define a lumen and wherein the distal portions define an opening providing access to the lumen, and wherein both the flange members extend a length of the cuff body; and

a row of resilient electrode elements at least partially embedded within the cuff body and spaced apart from each other along the length of the cuff body.

17. The electrode assembly of claim 16, wherein each electrode element includes:

a generally semi-circular first portion extending along an inner surface of the respective flange members 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 base.

18. The electrode assembly of claim 17, wherein the second portion of the electrode elements comprises a generally U-shaped portion defining a recess between two spaced apart legs and an apex pointing away from the first portion, wherein each respective leg is connected to and extends from the first portion.

19. The electrode assembly of claim 18, wherein the first portion defines a first segment and a second segment with the first and second segments extending outward and away in opposite directions from the second portion of the electrode element, each respective first and second segment connected a respective one of the legs of the generally U-shaped second portion, and wherein the first segment is exposed at the lumen along the second flange member and the second segment is exposed at the lumen along the third flange member, and wherein the second portion extends within the base of the cuff body.

20. The electrode assembly of claim 19, wherein the respective first and second segments, which are generally exposed along the inner surface of the respective second and third flange members, each have a distal end and the respective distal ends are embedded within the distal portion of the respective second and third flange members.

21. The electrode assembly of claim 19, wherein the cuff body comprises a protrusion that extends into the recess of the generally U-shaped second portion to embed the second portion within the base of the cuff body and that is exposed at the lumen.

22. The electrode assembly of claim 17, 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 be in releasable contact with both a portion of the second flange member and the third flange member and to overlap the 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.

23. The electrode assembly of claim 22 wherein the first flange member has a length sufficient for the second end to extend distally beyond the third flange member and at least around a bottom wall of the base of the cuff body.

24. The electrode assembly of claim 22, wherein the first flange member has a length sufficient to wrap the first flange member at least two times about the circumference of the cuff body before the second end terminates at a position overlapping the first end of the first flange member.

25. The electrode assembly of claim 22 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.

26. The electrode assembly of claim 25 wherein a diameter of the lumen defined by the electrode cuff body is automatically expandable, in response to an increasing diameter of a nerve in the lumen, via rotation of the distal portion of the second flange member away from the distal portion of the third flange member and via slidable movement of the first flange member relative to the second flange member with the first flange member having a length sufficient to maintain overlap with the substantially re-closable opening and with a majority of a length of the second flange member during the automatic expansion.

27. The electrode assembly of claim 26, wherein the distal portions of the respective second and third flange members are in releasable contact with each other.

28. The electrode assembly of claim 27, wherein the respective distal portions include reciprocating beveled ends.

29. The electrode assembly of claim 16, wherein the second flange member has a length substantially greater than a length of the third flange member such that the substantially re-closable opening is laterally relative to, and not directly opposite, the base of the cuff body.