Leads for electrostimulation of peripheral nerves and other targets

Patent metadata

Field	Value
Publication number	US-2017348522-A1
Application number	US-201715608573-A
Country	US
Kind code	A1
Filing date	May 30, 2017
Priority date	Jun 2, 2016
Publication date	Dec 7, 2017
Grant date	—

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.

First claim

What is claimed as new and desired to be protected by Letters Patent of the United States is:

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 actuation of the head element urges the tissue-engagement element away from or toward 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 . 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.

11 . The electrical stimulation system of claim 10 , further comprising a lead extension coupleable to both the electrical stimulation lead and the control module.

12 . 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; and a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes, wherein at least the distal end portion of the lead body includes a helical shape that variably locates the plurality of electrodes around the target tissue in both a longitudinal and circumferential direction.

13 . The lead of claim 12 , further comprising a stylet extending through at least the distal end portion of the lead body, wherein the stylet is helically shaped.

14 . The lead of claim 13 , wherein the stylet is nitinol wire.

15 . The lead of claim 12 , wherein the distal end portion of the lead body is molded into the helical shape.

16 . The lead of claim 12 , further comprising a sheath located over at least a section of the distal end portion of the lead body.

17 . The lead of claim 16 , wherein the sheath includes a slit for sliding the sheath over the lead body and the target tissue.

18 . A method of implanting an electrical stimulation lead, the method comprising:
moving a distal end portion of the lead of claim 12 to be within a vicinity of a target tissue; from a proximal end portion of the lead, inserting a stylet longitudinally into the lead, wherein a distal end portion of the stylet includes a helical shape; and manipulating the stylet to urge the distal end portion of the lead to helically wrap around the target tissue.

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

20 . 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 element manipulatable to extend through at least a portion of the paddle body, the anchoring element having a distal end portion adaptable to become a tissue-engaging element when the distal end portion is urged out of the paddle body.

Assignees

• Boston Scient Neuromodulation Corp

Inventors

• Stoffregen William Conrad
• Govea Michael X
• Clark Bryan Allen

Classifications

• A61N1/36071

  Pain · CPC title

• A61N1/36

  for stimulation · CPC title

• A61N1/0553 Primary

  Paddle shaped electrodes, e.g. for laminotomy · CPC title

• A61N1/36017

  with leads or electrodes penetrating the skin · CPC title

• A61N1/0558

  Anchoring or fixation means therefor · CPC title