Systems and methods for making and using a side-loading operating room cable of an electrical stimulation system

• US 9,101,775 B2
• Filed: 10/19/2012
• Issued: 08/11/2015
• Est. Priority Date: 10/19/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John Michael
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US13/655,874
• Publication Number:
  US 20130098678A1
• Time in Patent Office: 1,026 Days
• Field of Search: 607/36, 607/115
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/0488 Details about the lead
• 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 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: H01R 13/502 composed of different pieces H01R13/514 takes precedence
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

An operating room cable for electrically coupling a lead to a trial stimulator includes a trial stimulator connector electrically coupleable with the trial stimulator and a lead connector for receiving the lead. The lead connector includes a housing. A first lead aperture is defined in a second end of the housing in proximity to a first side of the housing. A first inner passage extends along an interior of the housing from the first lead aperture to the second end of the housing. A first stylet slit is defined along the first side of the housing and extends from a first end of the housing to the second end of the housing. The first stylet slit is formed between upper and lower casings of the housing. The first stylet slit is continuous with the first lead aperture and the first inner passage.

Claims

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

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

a trial stimulator connector disposed at the first end of the body, and electrically coupleable with the trial stimulator; and

a lead connector disposed at the second end of the body and electrically coupled to the trial stimulator connector, the lead connector configured and arranged to mechanically receive a proximal end of at least one electrical stimulation lead, the lead connector comprising

a housing comprising an upper casing and a lower casing coupled to the upper casing, the upper casing having an upper major surface and the lower casing having a lower major surface that opposes the upper major surface, the upper and lower casings collectively forming a perimeter section extending between the upper major surface and the lower major surface, the perimeter section comprising an elongated first side, an elongated second side opposing the first side, a first end extending between the first side and the second side, and a second end opposing the first end,

a first lead aperture defined in the second end of the housing in proximity to the first side of the housing,

a first inner passage extending along an interior of the housing from the first lead aperture to the first end of the housing, and

a first stylet slit defined along the first side of the housing and extending from the first end of the housing to the opposing second end of the housing, the first stylet slit formed along an interface between the upper casing and the lower casing with the upper casing forming a first wall of the first stylet slit and the lower casing forming an opposing second wall of the first stylet slit, wherein the first stylet slit is continuous with the first lead aperture and the first inner passage.

2. The operating room cable of claim 1, further comprising a plurality of first upper ribs extending along an inner surface of the upper casing, each of the first upper ribs comprising a flat portion and a concave portion, wherein the plurality of flat portions collectively form the first wall of the first stylet slit, and wherein the plurality of concave portions form an upper longitudinal portion of a wall of the first inner passage.

3. The operating room cable of claim 2, further comprising a plurality of first lower ribs extending along an inner surface of the lower casing, each of the first lower ribs comprising a flat portion and a concave portion, wherein the plurality of flat portions collectively form the second wall of the first stylet slit, and wherein the plurality of concave portions form a lower longitudinal portion of the wall of the first inner passage.

4. The operating room cable of claim 1, further comprising a first end stop disposed along the first inner passage, the first end stop forming a surface configured and arranged to prevent a proximal end of a first electrical stimulation lead inserted into the first lead aperture from extending beyond the first end stop while enabling a first stylet extending from the proximal end of the first lead to extend beyond the first end stop and through the first end of the lead connector to a location external to the housing.

5. The operating room cable of claim 4, wherein the first end stop comprises an upper concave portion extending along an inner surface of the upper casing along the first side of the housing, and a lower concave portion extending along an inner surface of the lower casing along the first side of the housing.

6. The operating room cable of claim 1, further comprising a first locking feature disposed external to the housing and disposed over the upper major surface, the first locking feature configured and arranged to actuate an electrical connection between the lead connector and at least one lead when the lead is received by, the first lead aperture.

7. The operating room cable of claim 6, wherein the upper major surface defines a first locking slit, the first locking slit having a longitudinal axis that extends between the first end and the second end of the housing.

8. The operating room cable of claim 7, further comprising at least one strut coupled to the first locking feature and extending through the first locking slit to the interior of the housing.

9. The operating room cable of claim 8, further comprising a first slide assembly disposed in the housing, the first slide assembly defining at least one curved track that receives the at least one strut.

10. The operating room cable of claim 9, further comprising a first printed circuit board coupled to the slide assembly.

11. The operating room cable of claim 10, further comprising a plurality of first connector pins disposed on the first printed circuit board.

12. The operating room cable of claim 11, wherein the first locking feature and the at least one strut are configured and arranged such that when the first locking feature is moved along the first locking slit, the at least one strut moves with the first locking feature, the movement of the at least one strut causing a corresponding movement of the plurality of first connector pins towards the first side of the housing.

13. The operating room cable of claim 11, wherein the first locking feature and the at least one strut are configured and arranged such that when the first locking feature is moved along the first locking slit, the at least one strut moves with the first locking feature, the movement of the at least one strut causing a corresponding movement of the plurality of first connector pins in a direction that is perpendicular to the movement of the first locking feature along the first locking slit.

14. The operating room cable of claim 1, wherein the housing further comprises

a second lead aperture defined in the second end of the housing in proximity to the second side of the housing,

a second inner passage extending along an interior of the housing from the second lead aperture to the second end of the housing, and

a second stylet slit defined along the second side of the housing and extending from the first end of the housing to the opposing second end of the housing.

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

the operating room cable of claim 1;

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

a first electrical stimulation lead having a distal end, a proximal end, a longitudinal length, and a diameter, the first lead comprising

a plurality of electrodes disposed on the distal end of the first lead,

a plurality of terminals disposed on the proximal end of the first lead, and

a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals,

wherein the proximal end of the first lead is insertable into the first lead aperture of the operating room cable.

16. The trial stimulation arrangement of claim 15, further comprising a first stylet having a proximal end, a distal end, and a diameter, the distal end of the first stylet insertable into the proximal end of the first lead such that the proximal end of the first stylet extends from proximal end of the first lead.

17. The trial stimulation arrangement of claim 16, wherein the first stylet comprises a handle disposed at the proximal end of the first stylet, the handle having a diameter that is larger than the diameter of the first stylet.

18. The trial stimulation arrangement of claim 17, wherein first stylet slit of the lead connector has a width that is less than the diameter of the first lead and no less than the diameter of the first stylet.

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

providing the operating room cable of claim 1;

partially retracting a proximal end of a first stylet from a proximal end of a first electrical stimulation lead;

inserting the exposed portion of the partially retracted first stylet into the first stylet slit of the operating room cable such that the proximal end of the first lead is disposed in proximity to the second end of the lead connector and a first handle disposed on the proximal end of the first stylet extends from the first end of the lead connector;

inserting the proximal end of the first lead into the first lead aperture of the lead connector until the proximal end of the first lead contacts a first end stop disposed in the first inner passage of the lead connector;

moving a first locking feature of the operating room cable along a first locking slit to lock a plurality of first pin connectors to terminals disposed on the received portion of the first lead; and

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

20. The method of claim 19, further comprising

partially retracting a proximal end of a second stylet from a proximal end of a second electrical stimulation lead;

inserting the exposed portion of the second stylet into a second stylet slit of the operating room cable such that the proximal end of the second lead is disposed in proximity to the second end of the lead connector and a second handle disposed on the proximal end of the second stylet extends from the first end of the lead connector;

inserting the proximal end of the second lead into the second lead aperture of the lead connector until the proximal end of the second lead contacts a second end stop disposed in a second inner passage of the lead connector; and

moving a second locking feature of the operating room cable along a second locking slit to lock a plurality of second pin connectors to terminals disposed on the received portion of the second lead.