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

• US 8,380,324 B2
• Filed: 08/20/2009
• Issued: 02/19/2013
• 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:
  US12/544,903
• Publication Number:
  US 20110046700A1
• Time in Patent Office: 1,279 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. A method for forming an implantable lead, the method comprising:

disposing an elongated conductor in a lead body of the lead;

disposing at least one safety element entirely within at least one lumen defined within an outer layer of the lead body, the safety element 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, wherein the at least one safety element is disposed on or in a stylet insertable into the at least one lumen of the lead body, and wherein the at least one safety element is configured and arranged to remain disposed within the at least one lumen after the lead is implanted into a patient;

coupling a first end of the conductor to an electrode disposed on a distal end of the lead;

coupling a second end of the conductor to a terminal disposed on a proximal end of the lead; and

electrically coupling the terminal to a control module configured and arranged to generate electrical signals for stimulating patient tissue via the electrode.

2. An implantable lead comprising:

lead body having a distal end, a proximal end, an outer layer and a longitudinal length, the lead body defining at least one lumen within the outer layer of the lead body, the at least one lumen extending along at least a portion of the lead body. the lead body comprising

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;

at least one safety element disposed entirely within at least a portion of the at least one lumen the at least one safety element 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, wherein the at least one safety element is configured and arranged to remain disposed within the at least one lumen after the lead is implanted; and

a stylet insertable into the at least one lumen of the lead body, wherein the at least one safety element is disposed on or in the stylet.

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

4. The lead of claim 3, 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.

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

6. The lead of claim 2, further comprising at least one conductor shunt coupling at least one of the conductors, at least one of the electrodes, or at least one of the terminals to the at least one safety element.

7. The lead of claim 6, wherein at least one of the conductor shunts, the electrode shunts, or the terminal shunts is configured and arranged to shunt electrical signals within a selected frequency range.

8. The lead of claim 6, wherein the at least one conductor shunt couples at least one of the conductors, at least one of the electrodes, or at least one of the terminals to the at least one safety element via at least one of a direct electrical connection via a filter, capacitive coupling, or inductive coupling.

9. The lead of claim 8, wherein the filter comprises at least one of a high-Pass filter or a bandpass filter.

10. The lead of claim 2, wherein the at least one safety element has a heat capacity that is substantially greater than the heat capacity of the lead body.

11. The lead of claim 2, wherein the at least one safety element is configured and arranged to alter one or more antenna characteristics of the lead.

12. The lead of claim 2, wherein at least one of the conductors is disposed in the lead body in a substantially straight configuration.

13. The lead of claim 2, wherein at least one of the conductors comprises a plurality of units, each of the units comprising

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

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

a third conductor segment extending along the elongated member 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.

14. The lead of claim 2, wherein the at least one safety element comprises a first section of conductive material physically separated from a second section of conductive material along a length of the stylet by a section of non-conductive material.

15. The lead of claim 2, wherein, the at least one safety element is configured and arranged to distribute heat along substantially the entire longitudinal length of the lead body.

16. An electrical stimulating system comprising:

an implantable lead with a lead body having a distal end, a proximal end, an outer layer, and a longitudinal length, the lead body defining at least one lumen within the outer layer of the lead body, the at least one lumen extending along at least a portion of the lead body, the lead body comprising

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; and

at least one safety element disposed entirely within at least a portion of the at least one lumen, the at least one safety element 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, wherein the at least one safety element is configured and arranged to remain disposed within the at least one lumen after the lead is implanted;

a stylet insertable into the at least one lumen of the lead body, wherein the at least one safety element is disposed on or in the stylet;

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

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the lead, the connector having a proximal end and a distal end 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 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 of the lead body.

17. The electrical stimulating system of claim 16, further comprising a lead extension having a proximal end and a distal end, the connector disposed on the distal end of the lead extension.

18. The electrical stimulating system of claim 17, wherein the proximal end of the lead extension is configured and arranged for insertion into another connector,

19. The electrical stimulating system of claim 17, wherein the lead extension comprises:

a lead extension body having a distal end, and a proximal end, the lead extension body defining at least one lumen extending along at least a portion of the lead extension body, the lead extension body comprising

a plurality of conductive contacts disposed on the distal end of the lead extension body,

a plurality of lead extension terminals disposed on the proximal end of the lead extension body, and

a plurality of conductors disposed in the lead extension body, each conductor electrically coupling at least one of the conductive contacts to at least one of the lead extension terminals; and

at least one safety dement disposed along at least a portion of the at least one lumen, the at least one safety element configured and arranged to reduce damage to patient tissue adjacent to the plurality of conductive contacts due to heating, induced electrical signals, or both when the lead extension is exposed to radio frequency irradiation, wherein the at least one safety element is configured and arranged to remain disposed within the at least one lumen after the lead extension is implanted.

20. The electrical stimulating system of claim 16, wherein the connector is disposed on the control module.