Nerve cuff with pocket for leadless stimulator

• US 9,700,716 B2
• Filed: 11/03/2015
• Issued: 07/11/2017
• Est. Priority Date: 06/09/2009
• Status: Active Grant

• Current Assignee: Setpoint Medical Corporation
• Original Assignee: Setpoint Medical Corporation
• Inventors: Loeb, Gerald E., Faltys, Michael A., Martin, Roy C., Scott, Steven E.
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US14/931,711
• Publication Number:
  US 20160051813A1
• Time in Patent Office: 616 Days
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An extravascular nerve cuff that is configured to hold a leadless, integral, implantable microstimulator. The nerve cuff may include a cuff body having a pocket or pouch for removably receiving the implantable device within. The nerve cuff can be secured around the nerve such that the electrodes of the device are stably positioned relative to the nerve. Furthermore, the nerve cuff drives the majority of the current from the stimulation device into the nerve, while shielding surrounding tissues from unwanted stimulation.

Claims

1. A nerve cuff for enclosing a leadless microstimulator in stable communication with a nerve, the nerve cuff comprising:

a flexible cuff body having a first end, a second end, and a nerve channel extending within the length of the cuff body from the first end to the second end for passage of a nerve;

a pocket within the cuff body, configured to removably hold the leadless microstimulator; and

an elongate opening slit extending the length of the cuff body configured to be opened to provide access to the pocket and the channel, and configured to be closed around the pocket and channel, enclosing the cuff body around the nerve.

2. The nerve cuff of claim 1, further comprising an external electrical contact on the outer surface of the cuff body configured to couple with the microstimulator.

3. The nerve cuff of claim 1, wherein the cuff body has a uniform thickness.

4. The nerve cuff of claim 1, wherein the cuff body has a non-uniform thickness.

5. The nerve cuff of claim 4, wherein the cuff body has a thickness between about 5 and about 20 mils.

6. The nerve cuff of claim 1, wherein the outer surface of the nerve cuff is substantially smooth and atraumatic.

7. The nerve cuff of claim 1, wherein the outer surface of the nerve cuff is contoured.

8. The nerve cuff of claim 1, wherein the channel comprises a support channel configured to support the nerve within therein, to prevent pinching of the nerve.

9. The nerve cuff of claim 1, wherein the elongate opening slit extends the length of the cuff body in an interlocking pattern.

10. The nerve cuff of claim 1, further comprising attachment sites in the elongate opening slit configured to help secure the slit closed.

11. The nerve cuff of claim 1, wherein the cuff body is formed of a flexible and biocompatible polymer.

12. The nerve cuff of claim 11, wherein the flexible and biocompatible polymer is a silicone based polymer.

13. The nerve cuff of claim 1, further comprising a conductive surface within the nerve channel configured to engage one or more electrical contacts on the microstimulator.

14. The nerve cuff of claim 1, wherein the first end and the second end of the cuff body each have a strain relief element.

15. The nerve cuff of claim 14, wherein the strain relief element is configured to coil around the nerve.

16. The nerve cuff of claim 14, wherein the strain relief element is tapered.

17. The nerve cuff of claim 1, wherein the cuff body further comprises one or more connection elements configured to secure the cuff body to the nerve.

18. The nerve cuff of claim 17, wherein the one or more connection elements is a suture hole or tab.