Self expanding electrode cuff

• US 8,340,785 B2
• Filed: 05/02/2008
• Issued: 12/25/2012
• 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): Layno, Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US12/114,352
• Publication Number:
  US 20090276024A1
• Time in Patent Office: 1,698 Days
• Field of Search: None
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An expandable electrode cuff of an implantable stimulation system that includes a base member, a first flange member extending from a proximal end along a first side wall of the base member to a first distal end, and a second flange member extending from a proximal end along a second side wall of the base member to a second distal end. The first flange member extends over both a top wall of the base member and the second flange member, and the second flange member extends over the top wall to form a lumen. The electrode cuff is capable of being advanced between a first position corresponding to both flange members extending over the top wall, a second position corresponding to the first flange member not extending over the top wall and the second flange member extending over the top wall, and a third position corresponding to both of the flange members not extending over the top wall.

Claims

1. An expandable electrode cuff of an implantable stimulation system, comprising:

a base member including a first side wall, a second side wall, a top wall and a bottom wall, wherein the first side wall is spaced apart from and generally opposite the second side wall, the top wall is spaced apart from and generally opposite to the bottom wall, and wherein the bottom wall extends from the first side wall to the second side wall; and

a first flange member including a proximal end and a first distal end;

a second flange member including a second distal end and a proximal end extending from the second side wall, wherein the second flange member is tapered such that the proximal end of the second flange member has a first thickness substantially greater than a second thickness of the second distal end of the second flange member; and

a third flange member including a third distal end and a proximal end extending from the first side wall, wherein the third distal end is positioned above the first side wall of the base member without extending over the top wall of the base member, and wherein the third flange member is tapered such that the proximal end of the third flange member has a first thickness substantially greater than a second thickness of the third distal end of the third flange member,

wherein the third flange member, the second flange member, and the base member are formed as a single unitary molded piece,

wherein the proximal end of the first flange member is fixedly engaged against the third flange member and the first flange member is biased to extend, from the third flange member, over both the top wall of the base member and the second flange member, and wherein the second flange member is biased to extend over the top wall of the base member to cause the second distal end to be spaced above, and in releasable contact with, the third distal end so that the third flange member and the second flange member form a lumen with the first flange member overlapping both the second and third flange members, and

wherein a cross-sectional length of each respective first and second flange member is substantially greater than a cross-sectional length of the third flange member.

2. The expandable electrode cuff of claim 1, wherein the electrode cuff is capable of being advanced between a first position, a second position, and a third position, the first position corresponding to both of the second flange member and the first flange member extending over the top wall of the base member with the first flange member extending in an opposite direction as the second flange member and the first flange member overlapping substantially the entire length of the second flange member, the second position corresponding to the first flange member not extending over the top wall of the base member and the second flange member extending over the top wall of the base member, and the third position corresponding to both of the second flange member and the first flange member not extending over the top wall of the base member.

3. The expandable electrode cuff of claim 1, wherein the first flange member and the second flange member are capable of being advanced between a first position, corresponding to a first diameter of the lumen at initial positioning of the electrode cuff about a nerve, and a second position corresponding to a second diameter greater than the first diameter subsequent to the initial positioning of the electrode cuff about the nerve,

wherein in the first position, the first distal end is positioned a first distance above the second side wall of the base member and the second distal end is positioned a second distance above the third distal end, and

wherein in the second position, the first distal end is positioned a third distance greater than the first distance above the second side wall of the base member and the second distal end is positioned a fourth distance greater than the second distance above the third distal end.

4. The expandable electrode cuff of claim 1, wherein the first thickness is at least one order of magnitude greater than the second thickness.

5. The expandable electrode cuff of claim 1, further comprising means for pulling one or both of the first flange member and the second flange member under a nerve during positioning of the expandable electrode cuff about the nerve.

6. The expandable electrode cuff of claim 1, and further comprising an implantable stimulation system comprising:

an implantable pulse generator;

a stimulation lead having a lead body extending from a lead body proximal end to a lead body distal end; and

a connector positioned at the lead body proximal end for electrically connecting the stimulation lead and the implantable pulse generator,

wherein the expandable electrode cuff is positioned at, and supported by, the lead body distal end.

7. The expandable electrode cuff of claim 1, wherein the point of releasable contact between the third distal end and the second distal end is located laterally of the first side wall of the base member.

8. The expandable electrode cuff of claim 1, wherein at least the third and second flange members are formed of a memory-based material and in a shape that biases the third and second flange members to form, prior to engagement about a nerve, a lumen in which the second distal end is in releasable contact with the third distal end.

9. The expandable electrode cuff of claim 1, wherein the length of the first flange member is configured to position the first flange member to overlap substantially the entire length of the second flange member.

10. The expandable electrode cuff of claim 1, wherein a portion of the base member, including a portion of the respective first and second side walls, extends generally outward and away from a proximal end of the third flange member and from a proximal end of the second flange, respectively.