Self expanding electrode cuff

• US 9,227,053 B2
• Filed: 05/01/2009
• Issued: 01/05/2016
• Est. Priority Date: 05/02/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bonde, Eric H., Testerman, Roy L., Herbert, Timothy P., Christopherson, Mark A., Geroy, Jesse D.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Bays, Pamela M
• Application Number:
  US12/990,702
• Publication Number:
  US 20110147046A1
• Time in Patent Office: 2,440 Days
• Field of Search: 607115-119
• US Class Current: 1/1
• 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 member including a top wall and at least one side wall; and

a first flange member including a first end and a second end;

a pair of resilient arcuate-shaped flange members that includes a second flange member and a third flange member,

wherein the respective second and third flange members each include a proximal portion and a distal end portion, with each respective proximal portion extending from the base outwardly and away from the other respective proximal portion, and

wherein the respective distal end portions are biased to extend toward each other and to be in releasable contact with each other when the cuff body is in a nerve-engaging position such that the respective second and third flange members define, in combination with the top wall of the base member, a lumen releasably enclosing a nerve and having a substantially re-closable opening, wherein the at least one side wall of the base member protrudes in first orientation away from the lumen, and

wherein the first end of the first flange member is secured to an outer surface of the third flange member and has a cross-sectional length sufficient to extend from its secured first end to overlap an outer surface of the third flange member and to overlap an outer surface of a portion of the second flange member when the distal end portions of the respective second and third flange members of the cuff body are in the nerve-engaging position, and wherein, when the cuff body is in the nerve-engaging position, at least the second end of the first flange member is in releasable slidable contact against the second flange member and the first flange member also overlaps the substantially re-closable opening between the second and third flange members,

wherein each of the first, second, and third 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, wherein in a cross-sectional orientation, each electrode element includes;

a generally arcuate first portion extending along an inner surface of the second flange member 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 member away from the lumen at a generally obtuse angle relative to the first portion, wherein the second portion is separate from, and independent of, a lead extending from the base member of the cuff body with the second portion being electrically coupled to the lead.

2. The electrode assembly of claim 1 wherein the first portion of each electrode element has an arcuate length limited to a 45 degree arc of the lumen, and wherein the obtuse angle is about 130 degrees.

3. The electrode assembly of claim 1 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.

4. The electrode assembly of claim 1, wherein the cross-sectional length of the first flange member is sufficient for the second end of the first flange member to extend distally beyond the second flange member and at least around a bottom wall of the base member.

5. The electrode assembly of claim 1, wherein the cross-sectional length of the first flange member is sufficient to wrap the first flange member at least two times about the circumference of the cuff body before the second end of the first flange member terminates at a position overlapping the secured first end of the first flange member.

6. The electrode assembly of claim 1 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 end portion of the second flange member away from the distal end 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.

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

8. 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 end 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.

9. The electrode assembly of claim 8 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.

10. 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.

11. The electrode assembly of claim 10 wherein the generally straight second portion of the respective electrode elements extends generally parallel to a cross-sectional longitudinal axis of the base member of the cuff body, wherein each electrode element further comprises a generally straight third portion extending within the base member 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.

24. The electrode assembly of claim 1, wherein the at least one side wall of the base member includes a first side wall and a second side wall, and wherein the base member includes a bottom wall extending between the first and second side walls.

25. The electrode assembly of claim 24, wherein the base member, the second flange member, and the third flange member are formed as a single, unitary molded piece.

12. An electrode assembly comprising:

an elongate cuff body including;

a base member including a top wall and at least one side wall;

a first flange member including a first end and an opposite second end; 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 member outwardly and away from the other respective proximal portion and a distal end portion that extends toward the other respective distal end portion, wherein the top wall of the base member and the two flange members at least partially define a lumen and wherein the distal end portions define an opening providing access to the lumen, wherein the at least one side wall of the base member protrudes in a first orientation away from the lumen and

wherein each of the first, second, and third flange members extend a length of the cuff body,

wherein the first end of the first flange member is secured to an outer surface of the second flange member and has a cross-sectional length sufficient to extend from the secured first end to overlap, and releasably contact, an outer surface of both the second flange member and the third flange member when at least the distal end portions of the respective second and third flange members are in a nerve-engaging position, wherein in the nerve-engaging position the second end of the first flange member terminates at a location over the third flange member the first flange member overlaps an opening between the distal end portions of the respective second and third flange members; 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, 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, wherein the first portion defines a first segment and a second segment that extend outwardly in opposite directions from each other; and

a second portion generally extending outward and away from a midpoint of the first portion, wherein the second portion extends into the base member away from the lumen,

wherein the second portion of each electrode element is separate from, and independent of, a lead extending from the base member of the cuff body with the second portion electrically couplable to the lead.

13. The electrode assembly of claim 12, 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.

14. The electrode assembly of claim 13, wherein each respective first and second segment is connected to a respective one of the legs of the generally U-shaped second portion, and wherein the second portion extends within the base of the cuff body.

15. The electrode assembly of claim 14, 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 end portion of the respective second and third flange members.

16. The electrode assembly of claim 14, 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.

17. The electrode assembly of claim 12 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.

18. The electrode assembly of claim 12, 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.

19. The electrode assembly of claim 12, 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.

20. The electrode assembly of claim 19 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 end portion of the second flange member away from the distal end 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.

21. The electrode assembly of claim 20, wherein the distal end portions of the respective second and third flange members are in releasable contact with each other.

22. The electrode assembly of claim 21, wherein the respective distal end portions include reciprocating beveled ends.

23. The electrode assembly of claim 12, 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.

26. The electrode assembly of claim 12, wherein the at least one side wall of the base member includes a first side wall and a second side wall, and wherein the base member includes a bottom wall extending between the first and second side walls.

27. The electrode assembly of claim 26, wherein the base member, the second flange member, and the third flange member are formed as a single, unitary molded piece.

28. The electrode assembly of claim 12, wherein the second and third flange members have generally equal cross-sectional lengths.