Pinch to open cuff electrode

• US 9,283,379 B2
• Filed: 09/30/2013
• Issued: 03/15/2016
• Est. Priority Date: 10/02/2012
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: True, Kyle, Soltis, Brian
• Primary Examiner(s): Lee, Erica
• Application Number:
  US14/041,020
• Publication Number:
  US 20140094887A1
• Time in Patent Office: 897 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0556 Cuff electrodes

Abstract

The present invention provides a cuff electrode assembly for implantation on a target nerve. The cuff electrode assembly can include a resilient cuff body configured to be disposed about the target nerve. The cuff body includes a first end portion having a first free end, and a second end portion having a second free end. The cuff electrode assembly further includes a first arm member and a second arm member each projecting radially outward from the cuff body and spaced from one another along the cuff body. The cuff body can be configured such that a force applied to urge the first and second arm members toward one another defines an open configuration of the cuff body configured to allow the cuff body to be positioned around the target nerve. The cuff electrode assembly further includes an electrode oriented to provide electrical stimuli to the target nerve.

Claims

1. A cuff electrode assembly for implantation on a target nerve, the cuff electrode assembly comprising:

a resilient cuff body configured to be disposed about the target nerve, the cuff body including a proximal end, a distal end, a first end portion having a first free end, and a second end portion having a second free end, the first free end and the second free end defining a gap in the cuff body between the first free end and the second free end, wherein the cuff body is pre-formed to assume a closed configuration having a generally annular cross-sectional shape, the gap extending straight along a longitudinal axis of the cuff body from the distal end of the cuff body to the proximal end of the cuff body;

a first arm member and a second arm member each projecting radially outward from the cuff body and spaced from one another along the cuff body, wherein each of the first and second arm members is disposed closer, as measured circumferentially around the cuff body in a first direction as compared to a second direction opposite the first direction, to the gap in the cuff body, and further wherein the cuff body is configured such that a force applied to urge the first and second arm members toward one another causes relative deflection of the second free end and the first free end away from one another to expand the gap and define an open configuration of the cuff body configured to allow the cuff body to be positioned around the target nerve; and

an electrode disposed at least partially within or on the cuff body oriented to provide an electrical stimuli to the target nerve when the cuff body is disposed about the target nerve.

2. The cuff electrode assembly of claim 1, wherein a length of the cuff extending from the first free end to the second free end spans an angle less than 360 degrees.

3. The cuff electrode assembly of claim 1, wherein the cuff body is pre-formed such that in the closed configuration the first free end and the second free end are spaced apart from one another without overlap so such that the cuff body further defines a generally circular cross-sectional.

4. The cuff electrode assembly of claim 1, wherein the first arm member is positioned closer than the second arm member to the first free end, and wherein the second arm member is positioned along the cuff body between the first arm member and the second free end.

5. The cuff electrode assembly of claim 1, wherein the cuff body is configured such that the first arm member remains relatively stationary and the second arm member deflects toward the first arm member upon application of a force to the second arm member in the direction of the first arm member so as to cause the cuff body to assume the open configuration.

6. The cuff electrode assembly of claim 1, wherein the cuff body is configured such that a length of the first end portion between the first arm member and the first free end remains relatively stationary upon application of a force to the second arm member urging the second arm member toward the first arm member.

7. The cuff electrode assembly of claim 1, wherein the cuff body is made substantially of a flexible, electrically insulating polymer.

8. The cuff electrode assembly of claim 7, wherein the flexible insulating polymer is silicone rubber.

9. The cuff electrode assembly of claim 7, wherein the cuff body further includes a reinforcing material in the flexible, electrically insulating polymer.

10. The cuff electrode assembly of claim 7, wherein the cuff body further includes a stiffening member within the flexible, insulating polymer.

11. The cuff electrode assembly of claim 1, further comprising a stiffening member configured to urge the cuff body to return to the pre-formed shape upon release of a force causing the cuff body to assume the open configuration.

12. The cuff electrode assembly of claim 11, wherein the stiffening member is embedded within a flexible insulating polymer and has a first end portion and an opposite second end portion, the first end portion disposed proximate the second arm member, and the second end portion disposed proximate the second free end of the cuff body.

13. The cuff electrode assembly of claim 1, wherein in the closed configuration the second end portion of the cuff body overlaps the first end portion of the cuff body.

14. A lead assembly configured for stimulating a target nerve, the lead assembly comprising:

at least one cuff electrode assembly configured for implantation about the target nerve, the cuff electrode assembly comprising;

a resilient cuff body configured to be disposed about the target nerve, the cuff body including a proximal end, a distal end, a first end portion having a first free end, and a second end portion having a second free end, the first free end and the second free end defining a gap in the cuff body between the first free end and the second free end, wherein the cuff body is pre-formed to assume a closed configuration having a generally annular cross-sectional shape, the gap extending straight along a longitudinal axis of the cuff body from the distal end of the cuff body to the proximal end of the cuff body;

a first arm member and a second arm member each projecting radially outward from the cuff body and spaced from one another along the cuff body, wherein each of the first and second arm members is disposed closer, as measured circumferentially around the cuff body in a first direction as compared to a second direction opposite the first direction, to the gap in the cuff body and further wherein the cuff body is configured such that a force applied to urge the first and second arm members toward one another causes relative deflection of the second free end and the first free end away from one another to expand the gap and define an open configuration of the cuff body configured to allow the cuff body to be positioned around the target nerve;

an electrode disposed at least partially within or on the cuff body oriented to provide an electrical stimuli to the target nerve when the cuff body is disposed about the target nerve;

a flexible lead body made of an insulating material, the lead body having a proximal end portion and a distal end portion;

an insulated flexible conductor member at least partially disposed within the lead body, the conductor member including a distal end electrically and mechanically coupled to the electrode of the cuff electrode assembly; and

a connector assembly coupled to the proximal end portion of the lead body and to the conductor member, the connector assembly configured to electrically couple the conductor member to an implantable stimulator.

15. The lead assembly of claim 14, wherein the at least one cuff electrode assembly includes a plurality of cuff electrode assemblies, and wherein the lead further includes a plurality of insulated, flexible conductor members at least partially disposed within the lead body, and wherein an electrode of each of the plurality of cuff electrode assemblies is electrically and mechanically coupled to one of the plurality of conductor members.

16. The lead assembly of claim 14, wherein the cuff electrode assembly further comprises a stiffening member configured to urge the cuff body to return to the pre-formed shape upon release of a force causing the cuff body to assume the open configuration.

17. The lead assembly of claim 14, wherein in the closed configuration the second end portion of the cuff body overlaps the first end portion of the cuff body.

18. A method for implanting a cuff electrode assembly on a target nerve, the method comprising:

inserting an implantable cuff electrode assembly within a patient'"'"'s body, the cuff electrode assembly including;

a resilient cuff body configured to be disposed about the target nerve, the cuff body including a proximal end, a distal end, a first end portion having a first free end, and a second end portion having a second free end, the first free end and the second free end defining a gap in the cuff body between the first free end and the second free end, wherein the cuff body is pre-formed to assume a closed configuration having a generally annular cross-sectional shape, the gap extending straight along a longitudinal axis of the cuff body from the distal end of the cuff body to the proximal end of the cuff body;

a first arm member and a second arm member each projecting radially outward from the cuff body and spaced from one another along the cuff body, wherein each of the first and second arm members is disposed closer, as measured circumferentially around the cuff body in a first direction as compared to a second direction opposite the first direction, to the gap in the cuff body, and further wherein the cuff body is configured such that a force applied to urge the first and second arm members toward one another causes relative deflection of the second free end and the first free end away from one another to expand the gap and define an open configuration of the cuff body configured to allow the cuff body to be positioned around the target nerve; and

an electrode disposed at least partially within or on the cuff body oriented to provide an electrical stimuli to the target nerve when the cuff body is disposed about the target nerve;

applying a force to at least one of the first and second arm members to urge the first and second arm members toward one another thereby causing the first and second free ends to deflect away from one another such that the cuff body widens the gap to assume the open configuration;

with the cuff body in the open configuration, placing the cuff electrode assembly proximate the target nerve such that the cuff body at least partially surrounds the target nerve; and

releasing the force urging the first and second arm members together to narrow the gap.

19. The method of claim 18, wherein the cuff electrode assembly is a first cuff electrode assembly of an implantable lead assembly including one or more additional cuff electrode assemblies, the one or more additional cuff electrode assemblies being coupled to the first cuff electrode assembly.

20. The method of claim 19, wherein the method further comprises simultaneously opening the first cuff electrode assembly and the one or more additional cuff electrode assemblies.