Stimulator systems and methods for selectively recruiting fascicles in hypoglossal nerve trunk

Patent metadata

Field	Value
Publication number	US-10967178-B2
Application number	US-201816118348-A
Country	US
Kind code	B2
Filing date	Aug 30, 2018
Priority date	Aug 30, 2017
Publication date	Apr 6, 2021
Grant date	Apr 6, 2021

Abstract

An electrode lead comprises a lead body, connector contacts affixed to the proximal end of the lead body, and a cuff body affixed to the distal end of the lead body. The cuff body is pre-shaped to transition from an unfurled state to a furled state, wherein the cuff body, when in the furled state has an inner surface for contacting a nerve and an overlapping inner cuff region and an outer cuff region. The electrode lead further comprise electrode contacts circumferentially disposed along the cuff body when in the furled state, such that at least one of the electrode contacts is located on the inner surface of the cuff body, and at least another of the electrode contacts is located between the overlapping inner and outer cuff regions. The electrode lead further comprises electrical conductors extending through the lead body respectively between the connector contacts and the electrode contacts.

First claim

What is claimed is:

1. An electrode lead, comprising:
an elongated lead body having a proximal end and a distal end;
an array of connector contacts affixed to the proximal end of the lead body;
a biologically compatible, elastic, electrically insulative cuff body affixed to the distal end of the lead body, the cuff body pre-shaped to transition from an unfurled state to a furled state, wherein the cuff body, when in the furled state has an inner surface for contacting a nerve and an overlapping inner cuff region and an outer cuff region;
an array of electrode contacts circumferentially disposed along the cuff body when in the furled state, such that at least one of the electrode contacts is located on the inner surface of the cuff body, and at least another of the electrode contacts is located between the overlapping inner and outer cuff regions; and
a plurality of electrical conductors extending through the lead body respectively between the array of connector contacts and the array of electrode contacts.

2. The electrode lead of claim 1 , wherein only one of the electrode contacts is located between the overlapping inner and outer cuff regions.

3. The electrode lead of claim 1 , wherein the inner surface of the furled cuff body has a diameter in the range of 2.5 mm to 4.0 mm.

4. The electrode lead of claim 1 , wherein the array of electrode contacts numbers at least three.

5. The electrode lead of claim 1 , wherein the array of electrode contacts numbers at least six.

6. The electrode lead of claim 1 , wherein, when the cuff body is in the unfurled state, a center-to-center spacing of each pair of adjacent ones of electrode contacts is equal to or less than twice a width of each electrode contact of the respective pair of electrode contacts.

7. A neurostimulation system, comprising:
the electrode lead of claim 1 ; and
a neurostimulator comprising a connector configured for receiving the proximal contacts of the electrode lead, and stimulation circuitry configured for generating and delivering an electrical stimulation pulse train to at least one of the electrode contacts of the electrode lead.

8. A method of using the electrode lead of claim 1 , comprising:
maintaining the cuff body in the unfurled state while placing the cuff body in contact with the nerve; and
placing the cuff body from the unfurled state into the furled state, such that the cuff body wraps around the nerve.

9. The method of claim 8 , wherein the size of the nerve allows the cuff body to wrap upon itself, such that the at least one electrode contact is in contact with the nerve, and the at least other electrode contact is between the overlapping inner and outer cuff regions without contacting the nerve.

10. The method of claim 8 , wherein the size of the nerve prevents the cuff body from wrapping upon itself, such that all of the electrode contacts are in contact with the nerve.

11. The method of claim 8 , wherein the nerve is a trunk of a hypoglossal nerve (HGN).

12. The method of claim 8 , wherein the array of electrode contacts numbers at least three.

13. The method of claim 8 , wherein the array of electrode contacts numbers at least six.

14. The method of claim 8 , wherein, when the cuff body is wrapped around the nerve, a center-to-center spacing of each pair of adjacent ones of electrode contacts is equal to or less than twice a width of each electrode contact of the respective pair of electrode contacts.

15. The method of claim 8 , further comprising delivering electrical stimulation energy to one or more of the electrode contacts to stimulate the nerve.

16. The method of claim 8 , further comprising delivering electrical stimulation energy between a pair of adjacent ones of the electrode contacts to stimulate the nerve in a bipolar mode.

17. A method of implanting an electrode lead in a patient, the electrode lead comprising a biologically compatible, elastic, electrically insulative cuff body and an array of electrode contacts disposed along the cuff body, the method comprising:
wrapping the cuff body upon itself around a nerve of the patient, such that there exists an inner surface that contacts the nerve and an overlapping inner cuff region and an outer cuff region, at least one of the electrode contacts being on the inner surface in contact with the nerve, and at least another of the electrode contacts being between the inner and outer overlapping regions of the cuff body without contacting the nerve.

18. The method of claim 17 , wherein the cuff body is pre-shaped to transition from an unfurled state to a furled state, the method further comprising:
maintaining the cuff body in the unfurled state while placing the cuff body in contact with the nerve; and
placing the cuff body from the unfurled state into the furled state, such that the cuff body wraps upon itself around the nerve.

19. The method of claim 17 , wherein only one of the electrode contacts is located between the overlapping inner and outer cuff regions.

20. The method of claim 17 , wherein the diameter of the nerve is in the range of 2.5 mm to 4.0 mm.

21. The method of claim 17 , wherein the nerve is a trunk of a hypoglossal nerve (HGN).

22. The method of claim 17 , wherein the array of electrode contacts numbers at least three.

23. The method of claim 17 , wherein the array of electrode contacts numbers at least six.

24. The method of claim 17 , wherein, when the cuff body is wrapped around itself around the nerve, a center-to-center spacing of each pair of adjacent ones of electrode contacts is equal to or less than twice a width of each electrode contact of the respective pair of electrode contacts.

Assignees

• The Alfred E Mann Foundation For Scient Research

Inventors

• NG Boon Khai
• Calderon Joseph L

Classifications

• A61N1/0556 Primary

  Cuff electrodes · CPC title

• A61B5/4818

  Sleep apnoea · CPC title

• A61N1/36139

  with automatic adjustment · CPC title

• A61B5/394

  specially adapted for electroglottography or electropalatography · CPC title

• A61N1/37211

  Means for communicating with stimulators · CPC title