Methods and systems for electrical stimulation including a shielded sheath

• US 9,782,581 B2
• Filed: 06/23/2015
• Issued: 10/10/2017
• Est. Priority Date: 06/27/2014
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Howard, Joshua Dale, Steinke, G. Karl
• Primary Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/748,071
• Publication Number:
  US 20150374977A1
• Time in Patent Office: 840 Days
• Field of Search: 607115, 607116, 607117, 607119, 607122, 607139
• 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 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads

Abstract

An electrical stimulation system includes an electrical stimulation lead with at least one lead body, electrodes disposed along the distal end portion of the lead body(ies), terminals disposed along the proximal end portion of the lead body(ies), and conductors electrically coupling the terminals to the electrodes. The electrical stimulation system also includes a lead extension coupleable to the electrical stimulation lead. The lead extension includes a connector for receiving the proximal end portion of the electrical stimulation lead. The electrical stimulation system further includes a sheath defining a sheath lumen to slidingly receive a portion of the electrical stimulation lead or a portion of the lead extension or a portion of both the electrical stimulation lead and the lead extension. The sheath includes a flexible sheath body and an elongate RF shield disposed within the sheath body and extending along the sheath.

Claims

1. An electrical stimulation system, comprising:

an electrical stimulation lead comprising at least one lead body having a distal end portion and a proximal end portion, a plurality of electrodes disposed along the distal end portion of the at least one lead body, a plurality of terminals disposed along the proximal end portion of the at least one lead body, and a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes; and

a first sheath defining a sheath lumen and configured and arranged to slide over and along the electrical stimulation lead to cover a selected portion of the electrical stimulation lead, the first sheath comprising a flexible sheath body and an elongate RF shield disposed within the sheath body and extending along the first sheath, wherein the first sheath is configured and arranged to radially stretch to cover a connector of a lead extension which has a diameter greater than a diameter of the electrical stimulation lead.

2. The electrical stimulation system of claim 1, further comprising a control module coupleable to the electrical stimulation lead.

3. The electrical stimulation system of claim 1, further comprising a lead extension coupleable to the electrical stimulation lead, the lead extension comprising a connector for receiving the proximal end portion of the at least one lead body of the electrical stimulation 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 portion of the at least one 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 at least on lead body of the electrical stimulation lead.

4. The electrical stimulation system of claim 3, further comprising a second sheath defining a sheath lumen configured and arranged to slide over and along the electrical stimulation lead to cover a selected portion of the lead extension, the second sheath comprising a flexible second sheath body and a second elongate RF shield disposed within the second sheath body and extending along the second sheath.

5. The electrical stimulation system of claim 3, wherein the first sheath is also configured and arranged to slide over and cover a portion of the lead extension including the connector.

6. The electrical stimulation system of claim 1, wherein the RF shield is a conductive braided tube.

7. The electrical stimulation system of claim 1, wherein the RF shield is a conductive coiled tube.

15. A method of implanting an electrical stimulation lead, the method comprising:

providing the electrical stimulation system of claim 1;

implanting a distal portion of the electrical stimulation lead;

forming a tunnel through patient tissue using a tunneling tool with the first sheath disposed over a portion of the tunneling tool;

removing the tunneling tool from the patient tissue leaving the first sheath in the patient tissue; and

sliding a portion of the electrical stimulation lead into the first sheath.

16. The method of claim 15, further comprising coupling the proximal end portion of the electrical stimulation lead to a control module leaving the first sheath within the patient tissue.

17. The method of claim 15, further comprising

forming another tunnel through patient tissue using the tunneling tool with a second sheath disposed over a portion of the tunneling tool, the second sheath comprising a flexible second sheath body and a second elongate RF shield disposed within the second sheath body and extending along the second sheath;

removing the tunneling tool from the patient tissue leaving the second sheath in the patient tissue;

sliding a portion of a lead extension into the second sheath; and

coupling the electrical stimulation lead to the lead extension.

18. The method of claim 15, further comprising coupling the electrical stimulation lead to a connector of a lead extension,

wherein sliding a portion of the electrical stimulation lead into the first sheath comprises sliding the portion of the electrical stimulation lead and a portion of the lead extension, including the connector, into the first sheath.

8. An electrical stimulation system, comprising:

an electrical stimulation lead comprising at least one lead body having a distal end portion and a proximal end portion, a plurality of electrodes disposed along the distal end portion of the at least one lead body, a plurality of terminals disposed along the proximal end portion of the at least one lead body, and a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes;

a lead extension coupleable to the electrical stimulation lead, the lead extension comprising a connector for receiving the proximal end portion of the electrical stimulation 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 portion of the at least one 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 at least one lead body of the electrical stimulation lead; and

a sheath defining a sheath lumen and configured and arranged to slide over and along the electrical stimulation lead or the lead extension to cover a selected portion of the electrical stimulation lead or a selected portion of the lead extension or a selected portion of both the electrical stimulation lead and the lead extension, the sheath comprising a flexible sheath body and an elongate RF shield disposed within the sheath body and extending along the sheath, wherein the sheath is configured and arranged to radially stretch to cover the connector of the lead extension which has a diameter greater than a diameter of the electrical stimulation lead.

9. The electrical stimulation system of claim 8, further comprising a control module coupleable to the lead extension.

10. The electrical stimulation system of claim 8, wherein the RF shield is a conductive braided tube.

11. The electrical stimulation system of claim 8, wherein the RF shield is a conductive coiled tube.

19. A method of implanting an electrical stimulation lead, the method comprising:

providing the electrical stimulation system of claim 8;

implanting a distal portion of the electrical stimulation lead;

forming a tunnel through patient tissue using a tunneling tool with the sheath disposed over a portion of the tunneling tool;

removing the tunneling tool from the patient tissue leaving the sheath in the patient tissue;

sliding a portion of the lead extension into the sheath; and

coupling the electrical stimulation lead to the lead extension.

20. The method of claim 19, further comprising coupling a proximal end portion of the lead extension to a control module leaving the sheath within the patient tissue.

12. An electrical stimulation system, comprising:

an implantable control module defining a port for receiving a proximal end of an electrical stimulation lead, the control module comprising a power source and an electronic subassembly coupled to the power source and configured and arranged to provide electrical stimulation current to the electrical stimulation lead for stimulation of patient tissue; and

a sheath defining a sheath lumen and configured and arranged to slide over and along the electrical stimulation lead to cover a selected portion of the electrical stimulation lead, the sheath comprising a flexible sheath body and an elongate RF shield disposed within the sheath body and extending along the sheath, wherein the sheath is configured and arranged to radially stretch to cover a connector of a lead extension which has a diameter greater than a diameter of the electrical stimulation lead.

13. The electrical stimulation system of claim 12, wherein the RF shield is a conductive braided tube.

14. The electrical stimulation system of claim 12, wherein the RF shield is a conductive coiled tube.