Slotted sleeve neurostimulation device

• US 10,814,127 B2
• Filed: 02/03/2017
• Issued: 10/27/2020
• Est. Priority Date: 02/05/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Nageri, Ranjan Krishna Mukhari, Shen, Tiffany
• Primary Examiner(s): Holmes, Rex R
• Assistant Examiner(s): Ghand, Jennifer L
• Application Number:
  US15/424,481
• Publication Number:
  US 20170224982A1
• Time in Patent Office: 1,362 Days
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

An electrical stimulation lead for a target nerve includes a sleeve having an inner surface and an outer surface, the inner surface defines a nerve channel. A longitudinal slit extends from the outer surface to the nerve channel and along an entire length of the sleeve. A width of the slit retains the target nerve within the nerve channel when the sleeve is closed and releases the target nerve when open. A plurality of electrodes are disposed on the inner surface of the sleeve. A flexible transition element electrically couples a lead body to the plurality of electrodes. Upper and lower sections of the sleeve rotates about a common hinge line (e.g., like a clam shell) located directly opposite the longitudinal slit. The material along the common hinge line remains “elastic” when the sleeve is moved from closed to open, and vice-versa.

Claims

1. An electrical stimulation lead for stimulating a target nerve, the electrical stimulation lead comprising:

an elongated sleeve having a first portion and a second portion, the first portion hingedly coupled to the second portion, the elongated sleeve having an inner surface that continually extends from the first portion to the second portion and an outer surface that continually extends from the first portion to the second portion, the inner surface defining a nerve channel to receive the target nerve, the elongated sleeve further having a longitudinal slit extending from the outer surface to the nerve channel, the longitudinal slit extending along an entire length of the elongated sleeve, wherein a section of the first portion hingedly moves relative to a section of the second portion to receive the target nerve into the nerve channel, wherein the elongated sleeve includes tapered end portions;

a plurality of electrodes disposed on the inner surface of the elongated sleeve;

a lead body;

a plurality of conductors extending along the lead body; and

a ribbon cable extending from the elongated sleeve and attached to the lead body to electrically couple the conductors extending along the lead body to the plurality of electrodes, wherein the ribbon cable includes a bellowed portion for strain relief.

2. The electrical stimulation lead of claim 1, wherein the section of the first portion rotates relative to the section of the second portion relative to a common hinge line located opposite the longitudinal slit.

3. The electrical stimulation lead of claim 2, wherein material along the common hinge line remains in a mechanically elastic range when the elongated sleeve is moved from a closed position to an open position.

4. The electrical stimulation lead of claim 1, further comprising at least one suture tab extending from the elongated sleeve.

5. The electrical stimulation lead of claim 4, wherein the at least one suture tab includes a pre-made suture hole.

6. The electrical stimulation lead of claim 4, wherein the at least one suture tab includes a suture slit that cooperates with the longitudinal slit of the elongated sleeve.

7. The electrical stimulation lead of claim 1, wherein the plurality of electrodes have a shape complementary to the inner surface of the elongated sleeve.

8. The electrical stimulation lead of claim 1, wherein a width of the longitudinal slit is configured to retain the target nerve within the nerve channel when the elongated sleeve is in a closed position and configured to receive or release the target nerve when the elongated sleeve is in an open position.

9. The electrical stimulation lead of claim 1, wherein the plurality of electrodes are arranged in two or more parallel rows or columns.

10. The electrical stimulation lead of claim 1, wherein an inward facing surface of each of the electrodes is flush with the inner surface of the elongated sleeve.

11. The electrical stimulation lead of claim 1, wherein an inward facing surface of each of the electrodes is recessed relative to the inner surface of the elongated sleeve.

12. An electrical stimulation system comprising:

the electrical stimulation lead of claim 1;

a control module coupleable to the electrical stimulation lead, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the electrical stimulation lead, the connector having a proximal end, a distal end, and a longitudinal length, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving a proximal end of the lead body of the electrical stimulation lead, and

a plurality of connector contacts disposed in the connector housing, a plurality of connector contacts configured and arranged to couple to at least one of a plurality of terminals disposed on the proximal end of the lead body of the electrical stimulation lead.

13. The electrical stimulation system of claim 12, further comprising a lead extension coupleable to both the electrical stimulation lead and the control module.

14. The electrical stimulation system of claim 12, further comprising at least one suture tab extending from the elongated sleeve.

15. The electrical stimulation system of claim 14, wherein the at least one suture tab includes a suture slit that cooperates with the longitudinal slit of the elongated sleeve, wherein the suture slit separates one of the at least one suture tab into two separate portions that are each attached to a different portion of the elongated sleeve and align with each other when the elongated sleeve is in a closed position.

16. An electrical stimulation lead for stimulating a target nerve, the electrical stimulation lead comprising:

an elongated sleeve having a first portion and a second portion, the first portion hingedly coupled to the second portion, the elongated sleeve having an inner surface that continually extends from the first portion to the second portion and an outer surface that continually extends from the first portion to the second portion, the inner surface defining a nerve channel to receive the target nerve, the elongated sleeve further having a longitudinal slit extending from the outer surface to the nerve channel, the longitudinal slit extending along an entire length of the elongated sleeve, wherein a section of the first portion hingedly moves relative to a section of the second portion to receive the target nerve into the nerve channel, wherein the elongated sleeve includes tapered end portions;

a plurality of electrodes disposed on the inner surface of the elongated sleeve;

a lead body;

a plurality of conductors extending along the lead body;

a ribbon cable extending from the elongated sleeve and attached to the lead body to electrically couple the conductors extending along the lead body to the plurality of electrodes; and

at least one suture tab extending from the elongated sleeve, wherein the at least one suture tab includes a suture slit that cooperates with the longitudinal slit of the elongated sleeve, wherein the suture slit separates at least one of the at least one suture tab into two separate portions that are each attached to a different portion of the elongated sleeve and align with each other when the elongated sleeve is in a closed position.

17. The electrical stimulation lead of claim 16, wherein each of the two separate portions of the at least one of the at least one suture tab includes a suture hole.

18. The electrical stimulation lead of claim 17, wherein the suture holes of the two separate portions align with each other when the elongated sleeve is in a closed position.

19. An electrical stimulation system comprising:

the electrical stimulation lead of claim 16;

a control module coupleable to the electrical stimulation lead, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the electrical stimulation lead, the connector having a proximal end, a distal end, and a longitudinal length, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving a proximal end of the lead body of the electrical stimulation lead, and

a plurality of connector contacts disposed in the connector housing, a plurality of connector contacts configured and arranged to couple to at least one of a plurality of terminals disposed on the proximal end of the lead body of the electrical stimulation lead.

20. The electrical stimulation system of claim 19, wherein the ribbon cable includes a bellowed portion for strain relief.