Systems and methods for altering one or more RF-response properties of electrical stimulation systems

• US 8,818,526 B2
• Filed: 02/15/2013
• Issued: 08/26/2014
• Est. Priority Date: 08/20/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: McDonald, Matthew Lee, Venook, Ross Daniel
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US13/769,002
• Publication Number:
  US 20130158642A1
• Time in Patent Office: 557 Days
• Field of Search: 607/63, 607115-117, 607/119, 607/121, 607/122, 600372-374, 600/377, 600/378
• US Class Current: 607/116
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: H01R 2201/12 for medicine and surgery
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

An implantable lead includes a lead body and at least one safety element. The lead body has a distal end and a proximal end. The lead body defines at least one lumen extending along at least a portion of the lead body. The lead body includes a plurality of electrodes disposed on the distal end of the lead body, a plurality of terminals disposed on the proximal end of the lead body, and a plurality of conductors disposed in the lead body, each conductor electrically coupling at least one of the electrodes to at least one of the terminals. The at least one safety element is disposed along at least a portion of the lead body and is configured and arranged to reduce damage to patient tissue adjacent to the plurality of electrodes due to heating, induced electrical signals, or both when the lead is exposed to radio frequency irradiation.

Claims

1. An electrical stimulation lead assembly comprising:

a lead configured and arranged for insertion into a body of a patient, the lead comprising

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

at least one lumen extending along the longitudinal length of the lead body, the at least one lumen configured and arranged to receive a stylet,

a plurality of electrodes disposed along the distal end portion of the lead body external to the at least one lumen,

a plurality of terminals disposed along the proximal end portion of the lead body external to the at least one lumen, and

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

at least one safety element disposed in the at least one lumen, the at least one safety element configured and arranged to reduce damage to patient tissue adjacent to the lead body due to heating, induced electrical signals, or both when the lead is exposed to radio frequency irradiation by drawing heat inwardly from the outer surface of the lead body;

wherein the at least one safety element is configured and arranged to draw heat inwardly from the outer surface of the lead body by actively altering heat conduction within the lead body.

2. The lead assembly of claim 1, wherein the at least one safely element comprises a cooling device configured and arranged for reducing the temperature of the lead.

3. The lead assembly of claim 2, wherein the cooling device comprises a heat pump configured and arranged for transferring heat from the lead body to the at least one safety element against a temperature gradient.

4. The lead assembly of claim 3, wherein the heat pump is configured and arranged to receive power from a control module coupled to the lead body.

5. The lead assembly of claim 1, wherein the at least one safety element is configured and arranged to draw heat from the outer surface of the lead body to the at least one lumen.

6. The lead assembly of claim 5, wherein the at least one safety element is configured and arranged to distribute heat drawn from the outer surface of the lead body along substantially an entire longitudinal length of the at least one lumen.

7. The lead assembly of claim 1, wherein the at least one safety element has a heat capacity that is substantially greater than a heat capacity of the lead body.

8. The lead assembly of claim 1, wherein the at least one safety element is formed as a solid.

9. The lead assembly of claim 8, wherein the at least one safety element comprises at least one of a metal, an alloy, a composite, or a polymer.

10. The lead assembly of claim 1, wherein the at least one safety element is formed as a fluid.

11. The lead assembly of claim 1, wherein at least one of the plurality of conductors is disposed in the lead body in a substantially-straight configuration.

12. The lead assembly of claim 1, wherein at least one of the plurality of conductors comprises a plurality of units, each unit comprising

a first conductor segment extending along the lead body from a beginning point to a first position,

a second conductor segment extending front the first position to a second position, and

a third conductor segment extending along the elongated lumber from the second position to an endpoint,

wherein the conductor segments are arranged so as to form alternating single-coil regions and multi-coil regions.

13. An electrical stimulating system comprising:

the lead assembly of claim 1;

to control module configured and arranged to electrically couple to the proximal end of the lead body of the lead assembly, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the lead body, the connector having a proximal end portion and a distal end portion, the connector comprising

a connector housing defining a port along the distal end portion of the connector, the port configured and arranged for receiving the proximal end portion of the lead body, and

a plurality of connector contacts disposed in the connector housing the 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.

14. The electrical stimulating system of claim 13, further comprising a lead extension having a proximal end portion and a distal end portion, the connector disposed on the distal end portion of the lead extension.

15. The electrical stimulating system of claim 14, wherein the proximal end portion of the lead extension is configured and arranged for insertion into another connector.

16. The electrical stimulating system of claim 14, wherein the at least one safety element is configured and arranged to distribute heat drawn from the outer surface of the lead body to at least a portion of the lead extension.

17. The electrical stimulating system of claim 13, wherein the connector is disposed on the control module.

18. The electrical stimulating system of claim 13, wherein the at least one safety element is configured and arranged to distribute heat drawn from the outer surface of the lead body to a least a portion of the control module.