Leads for electrostimulation of peripheral nerves and other targets

• US 10,493,269 B2
• Filed: 05/30/2017
• Issued: 12/03/2019
• Est. Priority Date: 06/02/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Stoffregen, William Conrad, Govea, Michael X., Clark, Bryan Allen
• Primary Examiner(s): Wehrheim, Lindsey G
• Application Number:
  US15/608,573
• Publication Number:
  US 20170348522A1
• Time in Patent Office: 917 Days
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36 for stimulation
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An electrical stimulation lead includes at least one lead body having a distal end portion, a proximal end portion, and a longitudinal length. The lead further includes a paddle body extending from the distal end portion of the at least one lead body, electrodes disposed along the paddle body, terminals disposed along the proximal end portion of the at least one lead body, and conductors electrically coupling the terminals to the electrodes. The lead further includes an anchoring device threadably disposed in at least a portion of the paddle body. The anchoring device has a head element and a tissue-engagement element fixed to the head element such that actuation of the head element urges the tissue-engagement element away from or toward the paddle body.

Claims

1. An electrical stimulation lead comprising:

at least one lead body having a distal end portion, a proximal end portion, and a longitudinal length;

a paddle body extending from the distal end portion of the at least one lead body;

a plurality of electrodes disposed along the paddle body;

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

a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes; and

an anchoring device threadably disposed in at least a portion of the paddle body, the anchoring device having a head element and a tissue-engagement element fixed to the head element,

wherein rotation of the head element in a first direction urges the tissue-engagement element to extend out of the paddle body and rotation of the head element in a second direction, opposite the first direction, urges the tissue-engagement element to retract into the paddle body.

2. The lead of claim 1, wherein the paddle body includes a protuberance extending from a remainder of the paddle body, wherein at least a portion of the anchoring device is disposed in the protuberance.

3. The lead of claim 1, wherein the head element includes a recessed region configured to be engaged by a tool.

4. The lead of claim 3, wherein the recessed region is hexagonally shaped.

5. The lead of claim 1, further comprising at least one additional anchoring device threadably disposed in a different portion of the paddle body.

6. The lead of claim 1, wherein the tissue-engagement element is a helical member.

7. The lead of claim 1, wherein the anchoring device is disposed along a side portion of the paddle body.

8. The lead of claim 1, wherein the anchoring device is disposed along an end portion of the paddle body.

9. The lead of claim 1, wherein the paddle body includes a curved section located between the anchoring device and at least one additional anchoring devices, the curved section configured for placement over a target tissue.

10. The lead of claim 1, further comprising a plug or septum disposed over the head element of the anchoring device.

11. The lead of claim 1, wherein the tissue-engagement element is configured so that the tissue-engagement element cannot fully disengage from the paddle body.

12. The lead of claim 1, wherein the tissue-engagement element is a spiraling, helical rod.

13. 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 portion 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.

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

15. An arrangement for electrical stimulation of a target tissue, the arrangement comprising:

an electrical stimulation lead comprising

a lead body having a distal end portion, a proximal end portion, and a longitudinal length,

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, and

a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes; and

a stylet configured for insertion into the lead body, wherein the stylet is helically shaped;

wherein, when the stylet is inserted into the lead body and the lead is implanted in the target tissue, at least the distal end portion of the lead body forms a helical shape that variably locates the plurality of electrodes around the target tissue in both a longitudinal and circumferential direction.

16. The lead of claim 15, wherein the stylet is nitinol wire.

17. A method of implanting an electrical stimulation lead, the method comprising:

moving a distal end portion of the lead of the arrangement of claim 15 to be within a vicinity of a target tissue;

from a proximal end portion of the lead, inserting the stylet longitudinally into the lead; and

manipulating the stylet to urge the distal end portion of the lead body of the lead to helically wrap around the target tissue.

18. The method of claim 17, wherein inserting the stylet includes inserting a nitinol guidewire.

19. An electrical stimulation lead for stimulating a target tissue, the lead comprising:

a lead body having a distal end portion, a proximal end portion, and a longitudinal length;

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 electrically coupling the plurality of terminals to the plurality of electrodes;

a sheath configured for locating over at least a section of the distal end portion of the lead body, wherein the sheath includes a slit for sliding the sheath over the lead body and the target tissue,

wherein at least the distal end portion of the lead body includes a helical shape that, when implanted in the target tissue, variably locates the plurality of electrodes around the target tissue in both a longitudinal and circumferential direction.

20. The lead of claim 19, wherein the distal end portion of the lead body is molded into the helical shape.