Electrical stimulation leads and systems with anchoring units having struts and methods of making and using

• US 9,649,489 B2
• Filed: 05/29/2015
• Issued: 05/16/2017
• Est. Priority Date: 06/02/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John M., Wechter, David Ernest, Leven, Jacob B., Baca, Ryan Michael
• Primary Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US14/726,233
• Publication Number:
  US 20150343199A1
• Time in Patent Office: 718 Days
• Field of Search: 607116, 607128
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An anchoring unit is disposed on a lead body of an electrical stimulation lead. The anchoring unit has a first end and a second end and includes a first attachment ring disposed at the first end, a second attachment ring disposed at the second end, and longitudinal struts extending linearly between, and coupled to, the first and second attachment rings. At least a portion of each longitudinal strut rests against the lead body in a retracted position, and each anchoring unit has a deployed position in which the first and second attachment rings are positioned closer together with the longitudinal struts extending away from the lead body to contact patient tissue and anchor the lead within the patient tissue.

Claims

1. An electrical stimulation lead, comprising:

a lead body having a distal end portion and a proximal end portion;

a plurality of electrodes disposed along the distal end portion of the lead body;

a plurality of terminals disposed along the proximal end portion of the lead body;

a plurality of conductors disposed within the lead body, each conductor of the plurality of conductors electrically coupling each of the plurality of terminals to at least one of the plurality of electrodes; and

an anchoring unit disposed along the distal end portion of the lead body, the anchoring unit having a first end and a second end and comprising

a first attachment ring disposed at the first end,

a second attachment ring disposed at the second end, wherein one of the first attachment ring or second attachment ring is fixed to the lead body and another one of the first attachment ring and the second attachment ring is slidably engaged around the lead body, and

a plurality of longitudinal struts extending linearly between, and coupled to, the first and second attachment rings, wherein at least a portion of each longitudinal strut rests against the lead body in a retracted position, and each anchoring unit is configured and arranged to have a deployed position in which the first and second attachment rings are positioned closer together with the longitudinal struts extending away from the lead body to contact patient tissue and anchor the lead within the patient tissue.

2. The electrical stimulation lead of claim 1, wherein the anchoring unit is disposed proximal to all of the plurality of electrodes.

3. The electrical stimulation lead of claim 1, wherein the anchoring unit is configured and arranged such that, in the deployed position, the longitudinal struts extend perpendicularly away from the lead body.

4. The electrical stimulation lead of claim 1, wherein the first attachment ring comprises an outer ring surface, an interior surface, and a side surface extending between the outer ring surface and the interior surface and the second attachment ring comprises an outer ring surface, an interior surface, and a side surface extending between the outer ring surface and the interior surface;

wherein at least one of the longitudinal struts comprises a biasing portion attached to the outer ring surface of the first attachment ring and extending outwardly away from the outer ring surface of the first attachment ring, the at least one of the longitudinal struts further comprising an attachment portion attached to the side surface of the second attachment ring.

5. The electrical stimulation lead of claim 1, wherein at least one of the longitudinal struts comprises a thinner portion having a smaller lateral width than an adjacent portion of the longitudinal strut and attached to the first attachment ring, wherein, in the deployed position, the longitudinal strut preferentially bends at the thinner portion.

6. The electrical stimulation lead of claim 1, wherein each of the longitudinal struts comprises a longitudinal edge and serrations extending along the longitudinal edge.

7. The electrical stimulation lead of claim 1, wherein each of the longitudinal struts comprises two opposing longitudinal edges and serrations extending along each of the two opposing longitudinal edges.

8. The electrical stimulation lead of claim 7, wherein each longitudinal strut of the anchoring unit is configured and arranged to form, in the deployed position, a corrugated region using the serrations.

9. The electrical stimulation lead of claim 1, wherein the anchoring unit further comprises an extension portion extending from the first attachment ring to the proximal end portion of the lead body and configured and arranged for manual operation by a user when the distal end portion of the lead body is implanted.

10. The electrical stimulation lead of claim 1, wherein one of the first and second attachment rings has a flared shape and is spaced apart from the lead body at one end.

12. The electrical stimulation lead of claim 1, wherein the anchoring unit is configured and arranged to preferentially adopt the deployed position unless constrained to adopt the retracted position.

14. The electrical stimulation lead of claim 1, wherein the longitudinal struts are configured and arranged to angle toward the proximal end portion of the lead body in the deployed position.

15. 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 the proximal end portion 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 the plurality of terminals disposed on the proximal end portion of the lead body of the electrical stimulation lead.

11. An electrical stimulation lead, comprising:

a lead body having a distal end portion and a proximal end portion;

a plurality of electrodes disposed along the distal end portion of the lead body;

a plurality of terminals disposed along the proximal end portion of the lead body;

a plurality of conductors disposed within the lead body, each conductor of the plurality of conductors electrically coupling each of the plurality of terminals to at least one of the plurality of electrodes; and

an anchoring unit disposed along the distal end portion of the lead body, the anchoring unit having a first end and a second end and comprising

a first attachment ring disposed at the first end,

a second attachment ring disposed at the second end,

a plurality of longitudinal struts extending linearly between, and coupled to, the first and second attachment rings, wherein at least a portion of each longitudinal strut rests against the lead body in a retracted position, and each anchoring unit is configured and arranged to have a deployed position in which the first and second attachment rings are positioned closer together with the longitudinal struts extending away from the lead body to contact patient tissue and anchor the lead within the patient tissue, and

a spring coupled to at least one of the first and second attachment rings and configured and arranged to bias the anchoring unit to the deployed position.

13. The electrical stimulation lead of claim 11, wherein one of the first attachment ring or second attachment ring is fixed to the lead body and another one of the first attachment ring and the second attachment ring is slidably engaged around the lead body.

17. The electrical stimulation lead of claim 11, wherein the first attachment ring comprises an outer ring surface, an interior surface, and a side surface extending between the outer ring surface and the interior surface and the second attachment ring comprises an outer ring surface, an interior surface, and a side surface extending between the outer ring surface and the interior surface;

wherein at least one of the longitudinal struts comprises a biasing portion attached to the outer ring surface of the first attachment ring and extending outwardly away from the outer ring surface of the first attachment ring, the at least one of the longitudinal struts further comprising an attachment portion attached to the side surface of the second attachment ring.

16. An anchoring unit having a first end and a second end, the anchoring unit comprising:

a first attachment ring disposed at the first end and configured and arranged to receive a first portion of a lead within the first attachment ring, wherein the first attachment ring comprises an outer ring surface, an interior surface, and a side surface extending between the outer ring surface and the interior surface;

a second attachment ring disposed at the second end and configured and arranged to receive a second portion of the lead within the second attachment ring, wherein the second attachment ring comprises an outer ring surface, an interior surface, and a side surface extending between the outer ring surface and the interior surface; and

a plurality of longitudinal struts extending linearly between, and coupled to, the first and second attachment rings, wherein at least one of the longitudinal struts comprises a biasing portion attached to the outer ring surface of first attachment ring and extending outwardly away from the outer ring surface of the first attachment ring, the at least one of the longitudinal struts further comprising an attachment portion attached to the side surface of the second attachment ring.

18. The anchoring unit of claim 16, wherein at least one of the longitudinal struts comprises a thinner portion having a smaller lateral width than an adjacent portion of the longitudinal strut and attached to the first attachment ring, wherein the longitudinal strut is configured and arranged to preferentially bend at the thinner portion.

19. The anchoring unit of claim 16, wherein each of the longitudinal struts comprises a longitudinal edge and serrations extending along the longitudinal edge.