ELECTRICAL STIMULATION SYSTEM WITH OPERATING ROOM CABLE/WOUND BANDAGE AND METHODS OF MAKING AND USING

• US 20160166836A1
• Filed: 12/08/2015
• Published: 06/16/2016
• Est. Priority Date: 12/12/2014
• Status: Abandoned Application

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Shanahan, Christopher, Howard, Joshua Dale
• Application Number:
  US14/962,938
• Publication Number:
  US 20160166836A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

An operating room cable assembly for electrically coupling at least one implantable electrical stimulation lead to a trial stimulator includes an elongated body; a trial stimulator connector disposed at one end of the elongated body; and a lead connector disposed at another end of the elongated body. The lead connector includes a connector body, a connector cover, a cover fastener disposed on the connector body, at least one lead channel to each receive a lead or lead extension, conductors coupled to the elongated body to make electrical contact with terminals disposed on the lead or lead extension, and a layer of medical adhesive disposed along a bottom surface of the lead connector. The layer of medical adhesive and the lead connector are configured and arranged for disposition over an exit wound from which the at least one lead or lead extension extends out of a skin of a patient.

Claims

1. An operating room cable assembly for electrically coupling at least one implantable electrical stimulation lead to a trial stimulator, the operating room cable assembly comprising:

an elongated body having a first end portion and an opposing second end portion;

a trial stimulator connector disposed along the second end portion of the elongated body; and

a lead connector disposed along the first end portion of the elongated body and electrically coupled to the trial stimulator connector, the lead connector having a top surface and a bottom surface, opposite the top surface, and configured and arranged to mechanically receive a proximal end portion of at least one electrical stimulation lead or lead extension, the lead connector comprising

a connector body,

a connector cover coupled to the connector body,

a cover fastener disposed on the connector body and configured and arranged to receive a portion of the connector cover and to hold the connector cover closed over the connector body,

at least one lead channel configured and arranged to receive the at least one electrical stimulation lead or lead extension,

a plurality of conductors coupled to the elongated body and configured and arranged to make electrical contact with terminals disposed on the at least one electrical stimulation lead or lead extension when the at least one electrical stimulation lead or lead extension is received in the at least one lead channel, and

a layer of medical adhesive disposed along a bottom surface of the lead connector, wherein the layer of medical adhesive and the lead connector are configured and arranged for disposition over an exit wound from which the at least one electrical stimulation lead or lead extension extends out of a skin of a patient.

2. The operating room cable assembly of claim 1, wherein the at least one lead channel is two lead channels, wherein each lead channel is configured and arranged to receive a proximal end portion of a different electrical stimulation lead or lead extension.

3. The operating room cable assembly of claim 1, wherein the lead connector comprises an exterior surface with at least a portion of the exterior surface of the lead connector coated with a soft polymer material.

4. The operating room cable assembly of claim 1, wherein the lead connector further comprises a water-resistant cover configured and arranged to be disposed over the connector cover and connector body and to permit the patient to take a shower with the lead connector covering the exit wound.

5. The operating room cable assembly of claim 1, wherein the connector body defines at least one lead aperture through the bottom surface of the lead connector.

6. The operating room cable assembly of claim 1, wherein the lead connector further comprises a sidewall disposed between the top and bottom surface of the lead connector, wherein the lead connector defines at least one lead aperture through the sidewall of the lead connector.

7. The operating room cable assembly of claim 1, wherein the lead connector is water-resistant when the connector cover is closed to permit the patient to take a shower with the lead connector covering the exit wound.

8. The operating room cable assembly of claim 1, wherein the cover fastener is slidable along the connector body.

9. The operating room cable assembly of claim 1, wherein the connector cover is sufficiently flexible to allow a portion of the connector cover to be folded underneath the cover fastener.

10. The operating room cable assembly of claim 1, wherein the connector cover is hingedly coupled to the connector body.

11. The operating room cable assembly of claim 1, wherein a portion of each of the lead channels is defined in both the connector body and the connector cover.

12. An insertion kit comprising:

the operating room cable assembly of claim 1; and

at least one electrical stimulation lead, each electrical stimulation lead having a distal end portion and a proximal end portion and comprising

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

a plurality of terminals disposed along the proximal end portion of the electrical stimulation lead, and

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

wherein the proximal end portion of the electrical stimulation lead is insertable into the lead connector of the operating room cable assembly.

13. The insertion kit of claim 12, further comprising at least one lead extension, each lead extension having a distal end portion and a proximal end portion and comprising a connector disposed on the distal end portion to receive the proximal end portion of the electrical stimulation lead, a plurality of terminals disposed along the proximal end portion of the lead extension, and a plurality of conductors electrically coupling the connector to the plurality of terminals of the lead extension, wherein the proximal end portion of the lead extension is insertable into the lead connector of the operating room cable assembly.

14. An insertion kit comprising:

the operating room cable assembly of claim 1; and

at least one lead extension, each lead extension having a distal end portion and a proximal end portion and comprising a connector disposed on the distal end portion to receive the proximal end portion of an electrical stimulation lead, a plurality of terminals disposed along the proximal end portion of the lead extension, and a plurality of conductors electrically coupling the connector to the plurality of terminals of the lead extension, wherein the proximal end portion of the lead extension is insertable into the lead connector of the operating room cable assembly.

15. A trial stimulation arrangement for an electrical stimulation system, the trial stimulation arrangement comprising:

the insertion kit of claim 12; and

a trial stimulator configured and arranged to generate electrical stimulation signals, the trial stimulator disposed external to a patient and coupleable to the trial stimulator connector of the operating room cable assembly of the insertion kit.

16. A trial stimulation arrangement for an electrical stimulation system, the trial stimulation arrangement comprising:

the insertion kit of claim 14; and

a trial stimulator configured and arranged to generate electrical stimulation signals, the trial stimulator disposed external to a patient and coupleable to the trial stimulator connector of the operating room cable assembly of the insertion kit.

17. A method for performing a trial stimulation on a patient, the method comprising:

providing the operating room cable assembly of claim 1;

advancing a distal end portion of a first electrical stimulation lead into the patient with a proximal end portion of the first electrical stimulation lead extending outward from the patient, wherein the distal end portion of the first electrical stimulation lead is advanced to a position where a plurality of electrodes disposed along the distal end portion of the first electrical stimulation lead are in proximity to a target stimulation location;

placing the proximal end portion of the first electrical stimulation lead into a one of the at least one lead channel of the lead connector of the operating room cable assembly while the connector cover is in an open position;

closing the connector cover with the cover fastener receiving a portion of the connector cover; and

electrically coupling the trial stimulator connector of the operating room cable assembly to a trial stimulator.

18. The method of claim 17, further comprising placing the lead connector over an exit wound in the skin of the patient with the layer of medical adhesive adhering to the skin.

19. A method for performing a trial stimulation on a patient, the method comprising:

providing the operating room cable assembly of claim 1;

advancing a distal end portion of a first electrical stimulation lead into the patient with a proximal end portion of the first electrical stimulation lead extending outward from the patient, wherein the distal end portion of the first electrical stimulation lead is advanced to a position where a plurality of electrodes disposed along the distal end portion of the first electrical stimulation lead are in proximity to a target stimulation location;

coupling the proximal end portion of the first electrical stimulation lead to a connector of a lead extension;

placing a proximal end portion of the lead extension into a one of the at least one lead channel of the lead connector of the operating room cable assembly while the connector cover is in an open position;

closing the connector cover with the cover fastener receiving a portion of the connector cover; and

electrically coupling the trial stimulator connector of the operating room cable assembly to a trial stimulator.

20. The method of claim 19, further comprising placing the lead connector over an exit wound in the skin of the patient with the layer of medical adhesive adhering to the skin.