Electrical stimulation system with intraoperative cable and methods of making and using

• US 10,195,446 B2
• Filed: 01/11/2016
• Issued: 02/05/2019
• Est. Priority Date: 01/16/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Howard, Joshua Dale, Shanahan, Christopher, Villarta, Geoffrey Abellana, Yoo, Peter J.
• Primary Examiner(s): Marlen, Tammie K
• Application Number:
  US14/992,931
• Publication Number:
  US 20160206891A1
• Time in Patent Office: 1,121 Days
• 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 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0595 Temporary leads
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: H01R 4/28 Clamped connections, spring connections made by means of terminals specially adapted for contact with, or insertion into, printed circuits H01R12/00

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 can include one or more buttons that can be pushed to load a lead into the lead connector and released to retain the lead. Alternatively, the lead connector can include a lever that can be operated to load the lead. A further alternative is a slider with a lead engagement element that can be slid between positions allowing loading of a lead and engagement of the lead. Other alternatives include a lead connector with doors that can swing open to allow loading of a lead or a collet/sleeve that can be tightened on the lead.

Claims

1. An operating room cable assembly for electrically coupling an 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 configured and arranged to mechanically receive a proximal end portion of a first electrical stimulation lead or lead extension, the lead connector comprising

a connector body,

a first lead channel defined within the connector body and configured and arranged to receive a first portion of the first electrical stimulation lead or lead extension,

a first button defining a first button lead channel configured and arranged to receive a second portion of the first electrical stimulation lead or lead extension,

a first spring disposed within the connector body and biasing the first button outwards from the connector body, wherein the first spring biases the first button so that the first button lead channel is misaligned with the first lead channel and so that the first button can be pushed to align the first button lead channel with the first lead channel so that the first and second portions of the first electrical stimulation lead or lead extension can be received in the first lead channel and the first button charnel, respectively, and so that when the first button is released the first spring biases the first button outward to hold the first electrical stimulation lead or lead extension within the lead connector,

a plurality of first connector contacts disposed within the connector body and arranged along the first lead channel and configured and arranged to make electrical contact with terminals disposed on the first electrical stimulation lead or lead extension when the first electrical stimulation lead or lead extension is received in the first lead channel; and

a first side-loading lead aperture associated with the first lead channel and sufficiently sized so that the first portion of the first electrical stimulation lead or lead extension can be laterally loaded into the first lead channel.

2. The operating room cable assembly of claim 1, wherein the lead connector further defines a first side-loading stylet aperture associated with the first lead channel and extending from the first side-loading lead aperture and sufficiently sized so that a portion of a stylet extending out of the first electrical stimulation lead or lead extension can be laterally loaded into the first lead channel.

3. The operating room cable assembly of claim 1, wherein the connector body further defines a recess and the first button comprises a protrusion disposed within the recess, wherein the recess and protrusion are configured and arranged to limit upward or downward movement of the first button.

4. The operating room cable assembly of claim 1, wherein the first button comprises at least one lead retention element associated with the first button lead channel to facilitate retention of the first electrical stimulation lead or lead extension within the first button lead channel.

5. The operating room cable assembly of claim 1, wherein the lead connector is further configured and arranged to mechanically receive a proximal end portion of a second electrical stimulation lead or lead extension, wherein the lead connector further comprises

a second lead channel defined within the connector body and configured and arranged to receive a first portion of the second electrical stimulation lead or lead extension,

a second button lead channel defined by the first button and configured and arranged to receive a second portion of the second electrical stimulation lead or lead extension, wherein the first spring biases the first button so that the second button lead channel is misaligned with the second lead channel and so that the first button can be pushed to align the second button lead channel with the second lead channel so that the first and second portions of the second electrical stimulation lead or lead extension can be received in the second lead channel and the second button lead channel, respectively, and so that when the first button is released the first spring biases the first button outward to hold the second electrical stimulation lead or lead extension within the lead connector, and

a plurality of second connector contacts disposed within the connector body and arranged along the second lead channel and configured and arranged to make electrical contact with terminals disposed on the second electrical stimulation lead or lead extension when the second electrical stimulation lead or lead extension is received in the second lead channel.

6. The operating room cable assembly of claim 5, wherein the lead connector further defines a second side-loading lead aperture associated with the second lead channel and sufficiently sized so that the first portion of the second electrical stimulation lead or lead extension can be laterally loaded into the second lead channel.

7. The operating room cable assembly of claim 6, wherein the lead connector further defines a second side-loading stylet aperture associated with the second lead channel and extending from the second side-loading lead aperture and sufficiently sized so that a portion of a stylet extending out of the second electrical stimulation lead or lead extension can be laterally loaded into the second lead channel.

8. The operating room cable assembly of claim 5, wherein the lead connector further defines a second side-loading stylet aperture associated with the second lead channel and sufficiently sized so that a portion of a stylet extending out of the second electrical stimulation lead or lead extension can be laterally loaded into the second lead channel.

9. The operating room cable assembly of claim 1, wherein the lead connector is further configured and arranged to mechanically receive a proximal end portion of a second electrical stimulation lead or lead extension, wherein the lead connector further comprises

a second lead channel defined within the connector body and configured and arranged to receive a first portion of the second electrical stimulation lead or lead extension,

a second button defining a second button lead channel configured and arranged to receive a second portion of the second electrical stimulation lead or lead extension,

a second spring disposed within the connector body and biasing the second button outwards from the connector body, wherein the second spring biases the second button so that the second button lead channel is misaligned with the second lead channel and so that the second button can be pushed to align the second button lead channel with the second lead channel so that the first and second portions of the second electrical stimulation lead or lead extension can be received in the second lead channel and the second button lead channel, respectively, and so that when the second button is released the second spring biases the second button outward to hold the second electrical stimulation lead or lead extension within the lead connector, and

a plurality of second connector contacts disposed within the connector body and arranged along the second lead channel and configured and arranged to make electrical contact with terminals disposed on the second electrical stimulation lead or lead extension when the second electrical stimulation lead or lead extension is received in the second lead channel.

10. The operating room cable assembly of claim 9, wherein the lead connector further defines a second side-loading lead aperture associated with the second lead channel and sufficiently sized so that the first portion of the second electrical stimulation lead or lead extension can be laterally loaded into the second lead channel.

11. The operating room cable assembly of claim 10, wherein the lead connector further defines a second side-loading stylet aperture associated with the second lead channel and extending from the second side-loading lead aperture and sufficiently sized so that a portion of a stylet extending out of the second electrical stimulation lead or lead extension can be laterally loaded into the second lead channel.

12. The operating room cable assembly of claim 9, wherein the lead connector further defines a second side-loading stylet aperture associated with the second lead channel and sufficiently sized so that a portion of a stylet extending out of the second electrical stimulation lead or lead extension can be laterally loaded into the second lead channel.

13. The operating room cable assembly of claim 1, wherein the lead connector further comprises a first stylet channel extending from the first lead channel and a first side-loading stylet aperture associated with the first stylet channel and extending from the first side-loading lead aperture and sufficiently sized so that a portion of a stylet extending out of the first electrical stimulation lead or lead extension can be laterally loaded into the first stylet channel.

14. The operating room cable assembly of claim 13, wherein the first stylet channel is narrower than the first lead channel.

15. The operating room cable assembly of claim 13, wherein the first side-loading stylet aperture is narrower than the first side-loading lead aperture.

16. A kit comprising:

the operating room cable assembly of claim 1; and

an 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.

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

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

the kit of claim 16; 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 kit.

19. A kit comprising:

the operating room cable assembly of claim 1; and

a lead extension having a distal end portion and a proximal end portion and comprising a connector disposed on the distal end portion of the lead extension 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.

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

the kit of claim 19; 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 kit.