Pinch to open cuff electrode

• US 9,114,250 B2
• Filed: 09/30/2013
• Issued: 08/25/2015
• 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:
  US14/041,402
• Publication Number:
  US 20140094888A1
• Time in Patent Office: 694 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0556 Cuff electrodes

Abstract

The invention describes a cuff electrode assembly and method for implanting that includes a resilient cuff body configured to be disposed about a nerve. The cuff body includes a first end portion and a second end portion. The cuff body can be pre-formed to define a closed configuration having a generally annular cross-sectional shape such that, in the closed configuration, the cuff body extends helically with the first and second end portions overlapping on different planes. The cuff electrode assembly 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 force applied to urge the first and second arm members toward one another causes relative deflection of the first end portion and the second end portion to define an open configuration of the cuff body.

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 having a proximal opening and a distal opening and including a first end portion having a first free end, a second end portion having a second free end, and a pinch hinge portion that extends from the proximal opening to the distal opening and connects the first end portion to the second end portion, wherein the proximal opening is defined at least in part by the pinch hinge portion and the first end portion, wherein the distal opening is defined at least in part by the pinch hinge portion and the second end portion, wherein the cuff body is pre-formed to define a closed configuration having a generally helical shape in which the cuff body is wound about a longitudinal axis, wherein the longitudinal axis extends through the distal opening and the proximal opening in a proximal-distal orientation, and wherein in the closed configuration the cuff body extends helically with the first and second end portions overlapping one another in different planes such that the first free end is proximal of the pinch hinge portion with respect to the longitudinal axis while the second free end is distal of the pinch hinge portion with respect to the longitudinal axis;

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 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 so as to 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 the cuff body is configured to extend greater than 360 degrees about the target nerve when placed thereon in the closed configuration.

3. The cuff electrode assembly of claim 1, wherein the force applied to urge the first and second arm members toward one another is operable to reduce a degree of circumferential overlap of the first end portion and the second end portion.

4. The cuff electrode assembly of claim 1, wherein the first arm member and the second arm member form a hinge angle with the pinch hinge portion, and wherein the hinge angle is less than 180 degrees while the cuff body is in the closed configuration.

5. The cuff electrode assembly of claim 1, wherein the pinch hinge portion is located substantially equidistant from the first free end and the second free end.

6. The cuff electrode assembly of claim 1, wherein the pinch hinge portion is located closer to the first free end than to the second free end.

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 closed configuration upon release of the force causing the cuff body to assume the open configuration.

12. An implantable lead assembly for stimulating a target nerve, the lead assembly comprising:

at least one cuff electrode assembly comprising;

a resilient cuff body configured to be disposed about the target nerve, the cuff body having a proximal opening and a distal opening and including a first end portion having a first free end, a second end portion having a second free end, and a pinch hinge portion that extends from the proximal opening to the distal opening and is located between the first and second end portions along a length of the cuff body, wherein the proximal opening is defined at least in part by the pinch hinge portion and the first end portion, wherein the distal opening is defined at least in part by the pinch hinge portion and the second end portion, wherein the cuff body is pre-formed to define a closed configuration having a generally helical shape in which the cuff body is wound about a longitudinal axis, wherein the longitudinal axis extends through the proximal opening and the distal opening in a proximal-distal orientation, and wherein in the closed configuration the cuff body extends helically with the first and second end portions overlapping one another in different planes such that the first free end is proximal of the pinch hinge portion with respect to the longitudinal axis while the second free end is distal of the pinch hinge portion with respect to the longitudinal axis;

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 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 so as to 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; and

a flexible lead body made of an insulative 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.

13. The lead assembly of claim 12, wherein the at least one cuff 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.

14. The lead assembly of claim 13, wherein the plurality of cuff electrode assemblies are configured to be opened and implanted simultaneously.

15. The lead assembly of claim 12, wherein the cuff body is made substantially of a flexible, electrically insulating polymer.

16. The lead assembly of claim 15, wherein the cuff body further includes a stiffening member within the flexible, insulating polymer.

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

inserting the 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 having a proximal opening and a distal opening and including a first end portion having a first free end, a second end portion having a second free end, and a pinch hinge portion that extends from the proximal opening to the distal opening and connects the first end portion to the second end portion, wherein the proximal opening is defined at least in part by the pinch hinge portion and the first end portion, wherein the distal opening is defined at least in part by the pinch hinge portion and the second end portion, wherein the cuff body is pre-formed to define a closed configuration having a helical shape in which the cuff body is wound about a longitudinal axis, wherein the longitudinal axis extends through the proximal opening and the distal opening in a proximal-distal orientation, and wherein in the closed configuration the cuff body extends helically with the first and second end portions overlapping one another in different planes such that the first free end is proximal of the pinch hinge portion with respect to the longitudinal axis while the second free end is distal of the pinch hinge portion with respect to the longitudinal axis;

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 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 so as to 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 the force to at least one of the first and second arm members to urge together the first and second arm members thereby causing the first and second free ends to deflect such that the cuff body assumes 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 to cause or allow the cuff body to close and thereby wrap substantially 360 degrees around the target nerve.

18. The method of claim 17, wherein the cuff electrode assembly further includes a stiffening member within the cuff body configured to:

stiffen the cuff body while being opened upon application of the force;

allow the cuff body to return to its closed configuration upon removal of the force; and

maintain the cuff body in its closed configuration around the target nerve upon removal of the force such that the first end portion and the second end portion overlap with each other in different planes.

19. The method of claim 17, 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.