Systems and methods for making and using electrical stimulation systems with improved RF compatibility

• US 8,868,207 B2
• Filed: 01/25/2012
• Issued: 10/21/2014
• Est. Priority Date: 01/26/2011
• 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:
  US13/357,910
• Publication Number:
  US 20120191167A1
• Time in Patent Office: 1,000 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 1/086 Magnetic resonance imaging [MRI] compatible leads

Abstract

An implantable electrical stimulation lead includes a plurality of conductors that extend along a lead body and that electrically couple electrodes to terminals. A first tissue coupler is electrically coupled to a first conductor of the plurality of conductors. The first tissue coupler includes a conductive first inner member, a non-conductive member disposed adjacent to at least a portion of the first inner member, and a conductive outer member disposed adjacent to at least a portion of the non-conductive member such that at least a portion of the non-conductive member is sandwiched between the first inner member and the outer member. The first inner member is electrically coupled to the first conductor. The outer member is disposed along a portion of an outer surface of the lead body such that the conductive outer member is exposed to patient tissue when the lead is implanted in a patient.

Claims

1. An implantable electrical stimulation lead comprising:

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

a plurality of stimulation electrodes disposed on the distal end of the lead body, wherein the plurality of stimulation electrodes are configured and arranged to stimulate patient tissue during normal operation of the electrical stimulation lead, the plurality of stimulation electrodes comprising a first stimulation electrode;

a plurality of terminals disposed on the proximal end of the lead body, the plurality of terminals comprising a first terminal;

a plurality of conductive wires extending along the longitudinal length of the lead body and electrically coupling the plurality of electrodes to the plurality of terminals, the plurality of conductive wires comprising a first conductive wire electrically coupling the first electrode to the first terminal;

a stylet lumen extending along the longitudinal length of the lead body, the stylet lumen configured and arranged for receiving a stylet; and

a first tissue coupler disposed along the lead body between the plurality of stimulation electrodes and the plurality of terminals such that the first tissue coupler is physically separate from each of the plurality of stimulation electrodes, the first tissue coupler electrically coupled to the first conductive wire, the first tissue coupler comprising

a first inner member that is cylindrically-shaped or C-shaped and that is conductive, wherein the first inner member is disposed concentrically over at least a portion of the stylet lumen,

a non-conductive member disposed adjacent to at least a portion of the conductive first inner member, and

an outer member that is conductive and that is disposed adjacent to at least a portion of the non-conductive member such that at least a portion of the non-conductive member is sandwiched between the first inner member and the outer member to completely physically separate the outer member from the first inner member, from each of the plurality of conductive wires, and from each of the stimulation electrodes;

wherein both the first stimulation electrode and the first inner member are conductively coupled to the first conductive wire, and wherein the outer member is disposed along a portion of the outer surface of the lead body such that the outer member is exposed to patient tissue when the lead is implanted in a patient;

wherein the first conductive wire forms less than one revolution around the stylet lumen.

2. The lead of claim 1, wherein the first tissue coupler is one of a plurality of tissue couplers disposed along, the longitudinal length of the lead body, each of the plurality of tissue couplers electrically coupled to a different conductive wire of the plurality of conductive wires.

3. The lead of claim 2, wherein the plurality of tissue couplers are intermittently disposed along the longitudinal length of the lead body.

4. The lead of claim 2, wherein the plurality of tissue couplers comprises a second tissue coupler electrically coupled to a second conductor wire of the plurality of conductor wires, and wherein the second conductive wire extends along the longitudinal length of the lead body such that the first inner member is peripheral to the second conductive wire along the lead body.

5. The lead of claim 4, wherein the first tissue coupler is configured and arranged to operate as a first capacitive element for facilitating propagation of energy at a first frequency through the first tissue coupler from the first conductive wire to patient tissue, wherein the second tissue coupler is configured and arranged to operate as a second capacitive element for facilitating propagation of energy at a second frequency through the second tissue coupler from the second conductive wire to patient tissue, and wherein the first frequency is different than the second frequency.

6. The lead of claim 5, wherein the first frequency and the second frequency are both no less than 20 MHz.

7. The lead of claim 4, wherein the outer member is a first outer member and the non-conductive member is a first non-conductive member, and wherein the second tissue coupler comprises a second non-conductive member.

8. The lead of claim 7, wherein the second tissue coupler comprises a second inner member that is conductive, wherein at least one of the first non-conductive member or the second non-conductive member is disposed adjacent to at least a portion of the second inner member, and wherein the first outer member is disposed adjacent to at least a portion of at least one of the first non-conductive member or the second non-conductive member.

9. The lead of claim 7, wherein the second tissue coupler comprises a second inner member that is conductive, wherein the second non-conductive member is disposed adjacent to at least a portion of the second inner member, and wherein a second outer member that is conductive is disposed adjacent to the second non-conductive member.

10. An electrical stimulation system comprising

the lead of claim 1;

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, a distal end, and a longitudinal length, 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.

11. The electrical stimulation system of claim 10, further comprising a lead extension electrically coupling the proximal end of the lead body to the control module, the lead extension comprising

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

a plurality of connector 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;

a plurality of conductors electrically coupling at least one of the connector contacts to at least one of the lead extension terminals, the plurality of conductors extending along the longitudinal length of the lead extension body; and

a first tissue coupler electrically coupled to a first conductor of the plurality of conductors, the first tissue coupler comprising a conductive first inner member, a non-conductive member disposed adjacent to at least a portion of the first inner member, and a conductive outer member disposed adjacent to at least a portion of the non-conductive member such that at least a portion of the non-conductive member is sandwiched between the first inner member and the outer member, wherein the first inner member is electrically coupled to the first conductor, and wherein the outer member is disposed along a portion of the outer surface of the lead extension body such that the outer member is exposed to patient tissue when the lead extension is implanted in a patient.

12. The lead of claim 1, wherein at least a portion of the first conductive wire is coiled longitudinally along at least a portion of the lead body, the coiled portion of the first conductive wire forming an inductive element.

13. The lead of claim 12, further comprising an additional coil that is co-wound with the coiled first conductive wire and that couples with patient tissue when the lead is implanted in the patient.

14. The lead of claim 1, wherein the first tissue coupler is configured and arranged to operate as a capacitive element that is configured and arranged to facilitate propagation of energy through the first tissue coupler from the first conductive wire to patient tissue adjacent to the outer member when the energy has a frequency that is no less than 20 MHz.

15. The lead of claim 1, wherein the first conductive wire is the sole conductive wire of the plurality of conductive wires that is coupled to the first inner member.

16. The lead of claim 1, wherein at least one of the plurality of conductive wires other than the first conductive wire extends through a center of the first inner member.

17. The lead of claim 1, wherein the non-conductive member is disposed concentrically over at least a portion of the first inner member, and the outer member is disposed concentrically over at least a portion of the non-conductive member.

18. The lead of claim 1, wherein the outer member is disposed over a portion of the outer surface of the lead body.

19. The lead of claim 1, wherein the outer member has a surface area that is different from a surface area of the first inner member.

20. The lead of claim 1, wherein the lead body is isodiametric.