Electrical stimulation cuff devices and systems

• US 10,485,969 B2
• Filed: 02/17/2017
• Issued: 11/26/2019
• Est. Priority Date: 02/19/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Govea, Michael X., Orinski, William George, Stoffregen, William Conrad
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US15/436,544
• Publication Number:
  US 20170239462A1
• Time in Patent Office: 1,012 Days
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

An electrical stimulation lead includes a stimulation cuff having an exterior surface and an interior surface that defines a nerve channel having a nerve channel axis. A plurality of electrodes are disposed on the interior surface of the cuff. A longitudinal opening extends through the cuff and further extends along an entire length of the cuff, wherein the opening is operable to receive a target nerve from a region outside of the cuff to within the nerve channel. A mount is disposed on the exterior surface of the cuff and radially offset from the nerve channel axis. A lead body is radially offset from the nerve channel axis and a plurality of conductors extend through the lead body, mount and cuff, with the plurality of conductors electrically coupled to the electrodes. The electrical stimulation lead may include a plurality of slots to permit tissue ingrowth.

Claims

1. An electrical stimulation lead comprising:

a stimulation cuff having a cuff length, an exterior surface, and an interior surface that defines a nerve channel having a nerve channel axis, wherein the stimulation cuff defines at least one slot extending through the stimulation cuff with the stimulation cuff defining a perimeter around an entirety of each of the at least one slot at both the exterior surface and the interior surface of the stimulation cuff, wherein each of the at least one slot has a slot length that extends more than 50%, but less than 100%, of the cuff length;

a plurality of electrodes disposed on the interior surface of the stimulation cuff, wherein the plurality of electrodes is arranged into a plurality of rows with each row extending parallel to the nerve channel axis, wherein each of the rows comprises at least two of the electrodes, wherein each of the at least one slot is disposed between two of the rows of the electrodes with at least two of the electrodes of each of the two rows disposed adjacent opposing sides of the respective slot;

a longitudinal opening extending through the stimulation cuff and further extending along the entire cuff length of the stimulation cuff, the longitudinal opening operable to receive a target nerve from a region outside of the stimulation cuff to within the nerve channel;

a mount disposed on the exterior surface of the stimulation cuff and radially offset from the nerve channel axis;

a lead body having a lead body axis radially offset from the nerve channel axis; and

a plurality of conductors extending through the lead body, mount and cuff, with the plurality of conductors electrically coupled to the electrodes.

2. The electrical stimulation lead of claim 1, wherein the stimulation cuff includes end portions configured to receive sutures.

3. The electrical stimulation lead of claim 1, further comprising cuff stiffeners embedded in the stimulation cuff proximate the longitudinal opening, wherein the cuff stiffeners are made of rigid plastic.

4. The electrical stimulation lead of claim 3, wherein at least one of the cuff stiffeners extends less than the entire cuff length of the stimulation cuff.

5. The electrical stimulation lead of claim 3, wherein at least one of the cuff stiffeners extends the entire cuff length of the stimulation cuff.

6. The electrical stimulation lead of claim 3, wherein the cuff stiffeners are cylindrical.

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

8. The electrical stimulation system of claim 7, further comprising a lead extension coupleable to both the electrical stimulation lead and the control module.

9. The electrical stimulation lead of claim 1, wherein each of the at least one slot has a rectangular shape.

10. The electrical stimulation lead of claim 1, wherein the slot length of each of the at least one slot is more than 70% of the cuff length.

11. The electrical stimulation lead of claim 1, wherein the electrodes of at least one of the rows of electrodes are longitudinally staggered relative to the electrodes of another one of the rows.

12. An electrical stimulation lead comprising:

a stimulation cuff having a cuff body with a cuff length, an interior surface, and an exterior surface, the interior surface defining a nerve channel having a nerve channel axis;

a plurality of electrodes disposed on the interior surface of the cuff body, wherein the plurality of electrodes is arranged into a plurality of rows with each row extending parallel to the nerve channel axis, wherein each row comprises at least two of the electrodes;

a longitudinal opening extending through the cuff body and further extending along an entire length of the cuff body, the longitudinal opening operable to receive a target nerve from a region outside of the stimulation cuff to within the nerve channel;

a plurality of slots each extending through the cuff body and each having a slot length that extends more than 50%, but less than 100%, of the cuff length, wherein each of the slots is disposed between two of the rows of the electrodes with at least two of the electrodes of each of the two rows disposed adjacent opposing sides of the respective slot, wherein each of the slots is configured to permit tissue ingrowth, wherein the cuff body defines a perimeter around an entirety of each of the slots at both the interior surface and the exterior surface of the cuff body;

a lead body having a lead body axis; and

a plurality of conductors extending through the lead body, mount and cuff, with the plurality of conductors electrically coupled to the electrodes.

13. The electrical stimulation lead of claim 12, wherein the slot length of each of the slots is more than 70% of the cuff length.

14. The electrical stimulation lead of claim 12, wherein each of the slots has a rectangular shape.

15. The electrical stimulation lead of claim 12, further comprising a mount disposed on the exterior surface of the cuff body and coupled to the lead body, wherein the lead body axis is radially offset from the nerve channel axis of the cuff body.

16. The electrical stimulation lead of claim 12, wherein the cuff body includes end portions configured to receive sutures.

17. The electrical stimulation lead of claim 12, further comprising cuff stiffeners embedded in the cuff body proximate the longitudinal opening, wherein the cuff stiffeners are made of rigid plastic.

18. The electrical stimulation lead of claim 17, wherein the cuff stiffeners are cylindrical.

19. An electrical stimulating system comprising:

the electrical stimulation lead of claim 12;

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

20. The electrical stimulation system of claim 19, further comprising a lead extension coupleable to both the electrical stimulation lead and the control module.