Systems and methods for inputting fluid into a lead of an electrical stimulation system

• US 9,205,251 B2
• Filed: 02/12/2014
• Issued: 12/08/2015
• Est. Priority Date: 03/13/2013
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Govea, Michael, McDonald, Matthew Lee, Barker, John Michael
• Primary Examiner(s): Kahelin, Michael
• Assistant Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US14/179,305
• Publication Number:
  US 20140277314A1
• Time in Patent Office: 664 Days
• US Class Current: 1/1
• 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 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads

Abstract

An insertion kit for an electrical stimulation system includes a lead with a lead body and a jacket disposed over at least a portion of the lead body. Apertures are defined along an outer surface of the lead body with each of the apertures extending completely through the jacket to an inner surface. The apertures include at least one first aperture. Conductors electrically couple electrodes and terminals disposed along the lead. Conductor insulation is disposed over each of the conductors. At least a portion of the conductor insulation is in fluid communication with the local environment external to the lead via the apertures. A fluid-insertion assembly is configured and arranged for inputting fluid into the lead, via the at least one first aperture, prior to implantation of the lead into the patient.

Claims

1. An insertion kit for an electrical stimulation system, the insertion kit comprising:

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

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

a jacket disposed over at least a portion of the longitudinal length of the lead body, the jacket having an outer surface and an opposing inner surface, at least a portion of the outer surface of the jacket forming at least a portion of an outer surface of the lead body, at least a portion of the inner surface of the jacket open to the lead body,

a plurality of apertures defined along the outer surface of the lead body with each of the plurality of apertures extending completely through the jacket to the inner surface, the plurality of apertures comprising at least one first aperture,

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

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

a plurality of conductors electrically coupling the plurality of electrodes to the plurality of terminals, and

conductor insulation disposed over each of the plurality of conductors,

wherein at least a portion of the conductor insulation is in fluid communication with the local environment external to the lead via the plurality of apertures; and

a fluid-insertion assembly configured and arranged for inputting fluid into the lead, via the at least one first aperture, prior to implantation of the lead into the patient, wherein the fluid-insertion assembly is configured and arranged for disposing over a portion of the jacket to completely cover the at least one first aperture.

2. The insertion kit of claim 1, wherein the at least one first aperture is defined along one of the distal end portion or the proximal end portion of the lead body.

3. The insertion kit of claim 1 wherein the fluid-insertion assembly is configured and arranged for inputting fluid into the lead to facilitate reaching an electrical equilibrium between the lead and interstitial fluid of the patient at a target stimulation location.

4. The insertion kit of claim 1, wherein the fluid-insertion assembly comprises a mounting body configured and arranged for disposing over a portion of the jacket and forming a watertight seal between the fluid-insertion assembly and the lead body.

5. The insertion kit of claim 4, wherein the fluid-insertion assembly comprises at least one fluid-insertion port coupled to the mounting body.

6. The insertion kit of claim 4, wherein the fluid-insertion assembly comprises a fluid reservoir with an adjustable volume coupled to the mounting body, the fluid reservoir configured and arranged to empty its contents into the at least one first aperture via the mounting body.

7. The insertion kit of claim 1, wherein the fluid-insertion assembly comprises a syringe.

8. The insertion kit of claim 1, wherein the fluid-insertion assembly comprises at least one piston.

9. The insertion kit of claim 1, wherein the fluid input to the lead is a saline solution.

10. An electrical stimulating system comprising:

the insertion kit of claim 1;

a control module coupleable to the lead of the insertion kit, 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 portion of the lead body of the 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 lead body.

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

providing a lead that comprises a jacket that is disposed over at least a portion of a longitudinal length of a lead body of the lead and that forms at least a portion of an outer surface of the lead body, the lead defining a plurality of apertures disposed along the outer surface of the lead body with each of the plurality of apertures extending completely through the jacket, the plurality of apertures comprising at least one first aperture, the lead further comprising a plurality of electrodes disposed along a distal end portion of the lead body, a plurality of terminals disposed along a proximal end portion of the lead body, a plurality of conductors electrically coupling the plurality of electrodes to the plurality of terminals, and conductor insulation disposed over each of the plurality of conductors, wherein at least a portion of the conductor insulation is in fluid communication with the local environment external to the lead via the plurality of apertures;

inputting fluid into the at least one first aperture using a fluid-insertion assembly; and

advancing the lead with input fluid to a target stimulation location within a patient.

12. The method of claim 11, wherein inputting fluid into the at least one first aperture comprises inputting fluid into the at least one first aperture until an equilibrium is reached between the lead and interstitial fluid of the patient at the target stimulation location.

13. The method of claim 12, wherein inputting fluid into the at least one first aperture comprises inputting fluid into the at least one first aperture until open spaces in the lead are at least 30% filled, but less than completely filled.

14. The method of claim 12, wherein inputting fluid into the at least one first aperture comprises inputting fluid into the at least one first aperture until open spaces in the lead are at least 50% filled, but less than completely filled.

15. The method of claim 12, wherein inputting fluid into the at least one first aperture comprises inputting fluid into the at least one first aperture until open spaces in the lead are at least 70% filled, but less than completely filled.

16. The method of claim 12, wherein inputting fluid into the at least one first aperture comprises inputting fluid into the at least one first aperture until some of the input fluid flows out from the lead through at least one second aperture of the plurality of apertures, and wherein the at least one first aperture and the at least one second aperture are defined along opposing end portions of the lead body.

17. The method of claim 11, wherein inputting fluid into the at least one first aperture comprises inputting fluid directly into the at least one first aperture using a syringe.

18. The method of claim 11, wherein inputting fluid into the at least one first aperture comprises pushing fluid from a fluid reservoir into the at least one first aperture, the fluid reservoir coupled to a mounting body disposed over a portion of the lead body with the mounting body completely covering the at least one first aperture.

19. The method of claim 11, wherein inputting fluid into the at least one first aperture comprises inputting fluid into a fluid-input port coupled to a mounting body, the mounting body disposed over a portion of the lead body and completely covering the at least one first aperture.