Force-decoupled and strain relieving lead and methods of making and using

• US 10,576,269 B2
• Filed: 12/29/2017
• Issued: 03/03/2020
• Est. Priority Date: 01/03/2017
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Steinke, G. Karl, Govea, Michael X.
• Primary Examiner(s): Voorhees, Catherine M
• Application Number:
  US15/859,136
• Publication Number:
  US 20180185633A1
• Time in Patent Office: 795 Days
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37514 Brain implants
• CPC Class Codes: A61N 1/378 Electrical supply

Abstract

An electrical stimulation lead includes a lead body having a distal end portion, a proximal end portion, and a longitudinal length; terminals disposed along the proximal end portion of the lead body; electrodes disposed along the distal end portion of the lead body; and conductors extending along the lead body and electrically coupling the terminals to the electrodes. The lead body includes an intermediate portion disposed between the proximal end portion and the distal end portion. The intermediate portion includes at least one separation element that extends longitudinally along the intermediate portion and the intermediate portion is deployable from an undeployed configuration to a deployed configuration responsive to operation of the at least one separation element.

Claims

1. An electrical stimulation lead, comprising:

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

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

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

a plurality of conductors extending along the lead body and electrically coupling the terminals to the electrodes;

wherein the lead body comprises an intermediate portion disposed between the proximal end portion and the distal end portion, wherein the intermediate portion comprises at least one separation element that extends longitudinally along the intermediate portion, wherein the intermediate portion is deployable from an undeployed configuration to a deployed configuration responsive to operation of the at least one separation element, wherein, in the undeployed configuration, the intermediate portion defines a central lumen with the conductors arranged concentrically about the central lumen of the intermediate portion, wherein, in the deployed configuration, the intermediate portion defines at least one row of the conductors, wherein each of the at least one row comprises at least two of the conductors, wherein each of the at least one row is linear or arc-shaped when the intermediate portion is in the deployed configuration.

2. The lead of claim 1, wherein the at least one separation element comprises at least two separation elements, wherein the intermediate portion further comprises at least two sections that are separated from each other by the at least two separation elements, wherein the at least two sections, when the intermediate portion is in the deployed configuration, are spaced apart from each other.

3. The lead of claim 1, wherein the at least one separation element is configured and arranged for operation by a stylet inserted into the lead and into the intermediate portion to deploy the intermediate portion from the undeployed configuration to the deployed configuration.

4. The lead of claim 1, wherein the at least one separation element comprises at least one material configured and arranged, responsive to application of a chemical reactant, a solvent, or light having a predefined wavelength, to deploy the intermediate portion from the undeployed configuration to the deployed configuration.

5. The lead of claim 1, wherein the at least one separation element comprises a pull strip configured to peel away from opposing sides of the intermediate portion when pulled to deploy the intermediate portion from the undeployed configuration to the deployed configuration.

6. The lead of claim 1, wherein the at least one separation element comprises a cutting groove that defines a path that, when cut, deploys the intermediate portion from the undeployed configuration to the deployed configuration.

7. The lead of claim 1, wherein the at least one separation element comprises a series of perforations that defines a path for separation to deploy the intermediate portion from the undeployed configuration to the deployed configuration.

14. An electrical stimulation system, comprising:

the lead of claim 1; and

a control module coupleable to the lead and comprising a housing and an electronic subassembly disposed in the housing.

8. An electrical stimulation lead, comprising:

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

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

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

a plurality of conductors extending along the lead body and electrically coupling the terminals to the electrodes;

wherein the lead body comprises an intermediate portion disposed between the proximal end portion and the distal end portion, wherein the intermediate portion comprises at least one separation element that extends longitudinally along the intermediate portion, wherein the intermediate portion is deployable from an undeployed configuration to a deployed configuration responsive to operation of the at least one separation element, wherein the at least one separation element comprises a slider operable by sliding the slider to deploy the intermediate portion from the undeployed configuration to the deployed configuration.

9. The lead of claim 8, wherein the slider is configured and arranged to cut the intermediate portion as the slider is moved along the at least one separation element to separate opposing edges of the intermediate portion.

10. The lead of claim 8, wherein the slider is configured and arranged for grasping by a user or tool to operate the slider.

11. The lead of claim 8, wherein the slider is configured and arranged for receiving a portion of a tool to operate the slider using the tool.

12. An electrical stimulation system, comprising:

the lead of claim 8; and

a control module coupleable to the lead and comprising a housing and an electronic subassembly disposed in the housing.

13. The lead of claim 8, further comprising a stylet having a barb to catch the slider and move the slider along the intermediate portion to deploy the intermediate portion from the undeployed configuration to the deployed configuration.

15. An electrical stimulation lead, comprising:

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

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

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

a plurality of conductors extending along the lead body and electrically coupling the terminals to the electrodes;

wherein the lead body comprises a cylindrical portion and a non-cylindrical portion, wherein the cylindrical portion comprises the distal end portion and the proximal end portion and the non-cylindrical portion is disposed between the proximal end portion and the distal end portion, wherein, in the non-cylindrical portion, the conductors are arranged in at least one row, wherein each of the at least one row comprises at least two of the conductors and wherein each of the at least one row is linear or arc-shaped, wherein the cylindrical portion comprises a central lumen in both the proximal end portion and the distal end portion, wherein the cylindrical portion further comprises a plurality of first conductor lumens disposed concentrically around the central lumen, wherein part of the conductors are disposed in the first conductor lumens, wherein the non-cylindrical portion defines at least one row of second conductor lumens with the conductors extending through the second conductor lumens, wherein each of the at least one row of the second conductor lumens comprises at least two of the second conductor lumens, wherein each of the at least one row of the second conductor lumens is linear or arc-shaped, and a number of the second conductor lumens equals a number of the first conductor lumens.

16. The lead of claim 15, wherein the lead is configured and arranged to permit a stylet to extend from the central lumen of the proximal end portion to the central lumen of the distal end portion while the stylet bypasses the non-cylindrical portion.

17. The lead of claim 15, wherein the non-cylindrical portion further comprises a stylet lumen that permits a stylet to extend from the central lumen of the proximal end portion, through the stylet lumen of the non-cylindrical portion, to the central lumen of the distal end portion.

18. The lead of claim 17, wherein the stylet lumen is disposed in one of the at least one row.

19. The lead of claim 17, wherein the non-cylindrical portion defines an attachment element and the attachment element comprises the stylet lumen and is adjacent to at least one of the at least one row of the conductors.

20. An electrical stimulation system, comprising:

the lead of claim 15; and

a control module coupleable to the lead and comprising a housing and an electronic subassembly disposed in the housing.