System and method for omni-directional bipolar stimulation of nerve tissue of a patient via a surgical tool

• US 10,039,915 B2
• Filed: 04/03/2015
• Issued: 08/07/2018
• Est. Priority Date: 04/03/2015
• Status: Active Grant

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: McFarlin, Kevin L., Courtney, Bryan L., Cantwell, Matthew L.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US14/678,485
• Publication Number:
  US 20160287861A1
• Time in Patent Office: 1,222 Days
• CPC Class Codes: A61B 17/28 Surgical forceps for holding suture needles or materials A61B17/0483; for removing or smashing calculi A61B17/221; surgical scissors A61B17/3201 ; obstetrical forceps A61B17/44; for inserting intraocular lenses A61F2/1662; hand-held gripping tools in general B25B7/00 ]
• CPC Class Codes: A61B 17/2812 with a single pivotal connection A61B17/29 takes precedence
• CPC Class Codes: A61B 17/2816 Pivots
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/32 Surgical cutting instruments A61B18/042 takes precedence; suture cutters A61B17/0467; instruments for ligaturing or cutting A61B17/128; instruments for rupturing the amniotic membrane A61B17/4208; specially adapted knives for eye surgery A61F9/0133
• CPC Class Codes: A61B 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2017/2825 Inserts of different material in jaws
• CPC Class Codes: A61B 2017/2945 Curved jaws
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin

Abstract

A surgical tool including first connecting elements, contacting elements, and conductive elements. The contacting elements are configured to contact nerve tissue of a patient. The conductive elements extend from the connecting elements to the contacting elements. The conductive elements have respective insulative outer layers. The insulative outer layers isolate the conductive elements from each other. The first connecting elements are configured to connect to and receive monophasic stimulation pulses from second connecting elements on a modular stimulation module. The modular stimulation module is configured to connect to the tool and other tools via the second connecting elements. The conductive elements are configured to transfer the monophasic stimulation pulses from the connecting elements to the contacting elements.

Claims

1. A surgical tool comprising:

a first arm and a second arm;

a first tip extending from the first arm and having a first inner side and an opposed first exterior side;

a second tip extending from the second arm and having a second inner side and an opposed second exterior side;

a first plurality of connecting elements, the first plurality of connecting elements comprises a first connecting element extending from the first arm and a second connecting element extending from the second arm;

a plurality of contacting elements that are conductive and configured to contact tissue of a patient in proximity of a nerve, the plurality of contacting elements including a first contacting element associated with the first tip and a second contacting element associated with the second tip; and

a plurality of conductive elements distinct from the first plurality of connecting elements and extending from the first plurality of connecting elements to the plurality of contacting elements, wherein the plurality of conductive elements have respective insulative outer layers, wherein the insulative outer layers isolate the plurality of conductive elements from each other,

wherein the first plurality of connecting elements are configured to connect to and receive a plurality of monophasic stimulation pulses from a second plurality of connecting elements on a modular stimulation module, wherein the modular stimulation module is configured to connect to the tool and a plurality of other tools via the second plurality of connecting elements,

wherein the plurality of conductive elements are configured to transfer current from the plurality of monophasic stimulation pulses from the first plurality of connecting elements to the plurality of contacting elements,

wherein the first inner side of the first tip faces the second inner side of the second tip,

wherein the first contacting element is on the first exterior side of the first tip and the second contacting element is on the second exterior side of the second tip such that the first and second contacting elements are on the opposite exterior sides of the first and second tips and do not face each other.

2. The surgical tool of claim 1, wherein:

the plurality of contacting elements comprises the first contacting element on the first tip and the second contacting element on the second tip;

a first portion of the plurality of conductive elements being a core of the first arm that extends from the first connecting element to the first contacting element; and

a second portion of plurality of conductive elements being a core of the second arm that extends from the second connecting element to the second contacting element.

3. The surgical tool of claim 1, wherein the tool is a forceps, and the first and second arms and the first and second tips form a part of the forceps.

4. The surgical tool of claim 1, wherein the insulative outer layers comprise a diamond like carbon (DLC) coating material.

5. The surgical tool of claim 1, wherein the insulative outer layers comprise a polymide bioplastic material, boron glass, a polymer material, or polytetrafluroethylene.

6. The surgical tool of claim 1, wherein the insulative outer layers coat the plurality of conductive elements except in areas of the first plurality of connecting elements and in areas of the plurality of contacting elements.

7. The surgical tool of claim 1, wherein:

the plurality of contacting elements are exposed portions of the plurality of conductive elements formed by the first and second arms; and

the exposed portions are not coated by the insulative outer layers.

8. The surgical tool of claim 1, wherein the plurality of contacting elements include a tip patch or a helical trace.

9. The surgical tool of claim 1, wherein:

the plurality of contacting elements comprise a plurality of conductive traces; and

the plurality of conductive traces extend around inner sides of the first and second tips and are isolated from each other.

10. An instrument comprising:

the tool of claim 1; and

the modular stimulation module configured to generate the plurality of monophasic stimulation pulses, the modular stimulation module configured to be disposed on and carried and supported by the tool.

11. The instrument of claim 10, wherein the modular stimulation module comprises:

the second plurality of connecting elements configured to connect to the first plurality of connecting elements; and

a bipolar stimulation module configured to generate the plurality of monophasic stimulation pulses.

12. A system comprising:

the instrument of claim 11; and

a nerve integrity monitoring device configured to generate a first request signal,

wherein the bipolar stimulation module is configured to, based on the first request signal, generate the plurality of monophasic stimulation pulses.

13. The instrument of claim 10, wherein the modular stimulation module is carried by the tool and wirelessly communicates with a monitoring device or a console interface module.

14. The surgical tool of claim 1, further comprising a first holding member extending from the first arm and a second holding member extending from the second arm, the first connecting element connected to the first holding member and the second connecting element connected to the second holding member.

15. The surgical tool of claim 14, wherein the first arm is pivotably coupled to the second arm at a pivot point and the modular stimulation module is configured to be carried by at least one of the first arm or the second arm of the surgical tool.

16. The surgical tool of claim 1, wherein the first connecting element is spaced apart from the second connecting element.

17. The surgical tool of claim 1, wherein each of the plurality of conductive elements extends between respective ends of a respective one of the first arm and the second arm.

18. The surgical tool of claim 1, wherein each of the plurality of conductive elements is a core of a respective one of the first arm and the second arm.

19. The surgical tool of claim 1, wherein the first plurality of connecting elements are implemented as connectors that connect to the modular stimulation module.

20. The surgical tool of claim 1, wherein the first plurality of connecting elements comprise:

a first connecting element directly connected to the first arm; and

a second connecting element directly connected to the second arm.

21. A surgical tool, comprising:

a first arm extending from a first holding member at a first proximal end to a first tip at a first distal end;

a second arm extending from a second holding member at a second proximal end to a second tip at a second distal end;

a first connecting element coupled to the first holding member at the first proximal end and a second connecting element connected to the second holding member at the second proximal end; and

a first contacting element at the first tip and configured to contact tissue to a patient in proximity of a nerve and a second contacting element at the second tip and configured to contact tissue of the patient in proximity of a nerve, wherein the first contacting element and the second contacting element are conductive,

wherein the first arm is a first conductive element extending from the first connecting element at the first proximal end to the first contacting element at the first distal end,

wherein the second arm is a second conductive element extending from the second connecting element at the second proximal end to the second contacting element at the second distal end,

wherein the first and second connecting elements are configured to connect to a modular stimulation module to deliver a plurality of stimulation pulses to the first and second contacting elements at the first and second tips, and

wherein the first arm is pivotably connected to the second arm at a pivot point such that the first holding member is on a first side of the pivot point and the first tip is on a second opposite side of the pivot point and the second holding member is on the first side of the pivot point and the second tip is on the second opposite side of the pivot point.

22. The surgical tool of claim 21, wherein the surgical tool is a surgical forceps.

23. The surgical tool of claim 21, wherein the first and second arms each have insulated outer layers to isolate the first and second conductive elements formed by the first and second arms.

24. The surgical tool of claim 23, wherein the insulative outer layers comprise a diamond like carbon (DLC) coating material.

25. The surgical tool of claim 21, wherein the first contacting element and the second contacting element are on opposite exterior sides of the first and second tips and do not face each other.

26. An instrument comprising:

the tool of claim 21; and

the modular stimulation module configured to generate the plurality of stimulation pulses, the modular stimulation module configured to be disposed on and carried by the tool.

27. The surgical tool of claim 21, wherein:

the first connecting element is distinct from the first conductive element; and

the second connecting element is distinct from the second conductive element.

28. A surgical tool, comprising:

a first plurality of connecting elements;

a plurality of contacting elements configured to contact tissue of a patient to deliver a current in proximity of a nerve, wherein the plurality of contacting elements are conductive; and

a plurality of conductive elements extending from the first plurality of connecting elements to the plurality of contacting elements, wherein the plurality of conductive elements have respective insulated outer layers, wherein the insulated outer layers isolate the plurality of conductive elements from each other,

wherein the first plurality of connecting elements are configured to detachably connect to a second plurality of connecting elements on a modular stimulation module, wherein the modular stimulation module is configured to connect to and be disposed on and carried and supported by the tool, and

wherein the plurality of conducting elements are configured to transfer current from an internal power source in the modular stimulation module from the first plurality of connecting elements to the plurality of contacting elements, where the plurality of contacting elements are configured to deliver the current sourced by the internal power source and adjusted by a user interface on the modular stimulation module to the tissue of the patient.

29. The surgical tool of claim 28, wherein the first plurality of connecting elements comprises a first connecting element and a second connecting element, wherein the first connecting element extends from the surgical tool and is spaced apart from the second connecting element extending from the surgical tool.

30. An instrument comprising:

the tool of claim 28; and

the modular stimulation module configured to generate a plurality of monophasic stimulation pulses.

31. The surgical tool of claim 28, wherein the plurality of conductive elements are distinct from the first plurality of connecting elements.