Bipolar electrical stimulus probe with planar electrodes

• US 6,292,701 B1
• Filed: 07/29/1999
• Issued: 09/18/2001
• Est. Priority Date: 08/12/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Prass, Richard L., Hacker, David C.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/362,891
• Time in Patent Office: 782 Days
• Field of Search: 607/115, 607/116, 607/145, 607/149, 607/150
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A hand-held bipolar electrical stimulus probe includes first and second insulated conductors having unequal diameters and a stable side-by-side orientation. The conductors are provided with visually perceptible indicia such as color coding for identification. The conductors are carried within a flexible jacket and the terminal portions thereof are deformable. The conductors are each insulated substantially up to their tips to prevent current shunting. The probe may include a momentary contact switch permitting selective monopolar or bipolar operation.

Claims

1. A hand-held instrument for monitoring or electrically stimulating exposed, subcutaneous tissue of a living body, comprising:

an elongate cannula having an open proximal end, an open distal end and a lumen there between;

a handle carried on said cannula proximal end;

an elongate cathode conductor including a proximal end and a distal end having a distal end surface having a first diameter, said cathode conductor having sufficient rigidity to provide resistance to bending when in operable contact with subcutaneous tissue;

said cathode conductor being disposed within a first flexible insulating sheath;

an elongate anode conductor including a proximal end and a distal end having a planar distal end surface having a second diameter larger than said cathode conductor distal end first diameter, said anode conductor having sufficient rigidity to provide resilient resistance to bending when in operable contact with subcutaneous tissue;

said anode conductor being disposed within a second flexible insulating sheath;

said cathode conductor and said anode conductor being carried within said cannula lumen, wherein said cathode conductor distal end and said anode conductor distal end project distally beyond said cannula open distal end.

2. The hand-held instrument of claim 1, said first flexible insulating sheath including a colored surface.

3. The hand-held instrument of claim 2, said first flexible insulating sheath including a black surface.

4. The hand-held instrument of claim 1, said cathode conductor and said anode conductor being carried within an elongate non-conductive, flexible jacket having a distal end, wherein said cathode conductor distal end and said anode conductor distal end project distally beyond said jacket distal end;

and

said flexible jacket, cathode conductor and said anode conductor being carried within said cannula lumen, wherein said flexible jacket distal end, said cathode conductor distal end and said anode conductor distal end project distally beyond said cannula open distal end.

5. The hand-held instrument of claim 4, said flexible segment extending beyond said cannula distal end in an unsupported malleable length;

said jacket unsupported malleable length being in the range of one half inch to one inch.

6. The hand-held instrument of claim 1, wherein said cathode and anode distal end surfaces lie in a plane disposed at an angle to the elongate cathode conductor axis.

7. The hand-held instrument of claim 6, wherein said plane is disposed at an angle fifteen degrees from normal to the elongate cathode conductor axis.

8. A hand-held instrument for monitoring or electrically stimulating exposed, subcutaneous tissue of a living body, comprising:

an elongate cannula having an open proximal end, an open distal end and a lumen there between;

a handle carried on said cannula proximal end;

an elongate, flexible, cathode conductor including a proximal end and a distal end having a substantially planar distal end surface, said cathode conductor being malleably deformable and having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

said cathode conductor being disposed within a first flexible insulating sheath extending distally to and substantially flush with the distal end of said cathode conductor, said sheath leaving said cathode conductor planar distal end surface exposed;

an elongate, flexible anode conductor including a proximal end and a distal end having a planar distal end surface, said anode conductor being malleably deformable and having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

said anode conductor being disposed within a second flexible insulating sheath extending distally to and substantially flush with the distal end of said anode conductor, said sheath leaving said anode conductor planar distal end surface exposed;

wherein at least one of said cathode conductor and said anode conductor include visible identifying indicia; and

said cathode conductor and said anode conductor being carried within said cannula lumen, wherein said cathode conductor distal end and said anode conductor distal end project distally beyond said cannula open distal end.

9. The hand-held instrument of claim 8, said visible identifying indicia comprising a color coded flexible insulating sheath.

10. The hand-held instrument of claim 9, said color coded flexible insulating sheath comprising a black plastic insulating sheath disposed on said cathode conductor.

11. The hand-held instrument of claim 10, said handle further including a tactile salient feature aligned with said cathode conductor.

17. The hand-held instrument of claim 10, wherein said instrument operates in a bipolar mode when said switch is actuated.

12. A hand-held instrument for monitoring or electrically stimulating exposed, subcutaneous tissue of a living body, comprising:

a handle having a proximal end and a distal end;

an elongate, flexible, cathode conductor including a proximal end and a distal end having a distal end surface, said cathode conductor having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

said cathode conductor being disposed within an insulating sheath, said sheath leaving said cathode conductor distal end surface exposed;

an elongate, flexible anode conductor including a proximal end and a distal end having a distal end surface, said anode conductor having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

said anode conductor being disposed within an insulating sheath, said sheath leaving said anode conductor distal end surface exposed;

said handle further including a switch having first and second terminals;

said first switch terminal being connected to one of said cathode conductor and said anode conductor; and

said cathode conductor and said anode conductor being carried by said handle, wherein said cathode conductor distal end and said anode conductor distal end project distally beyond said handle distal end.

13. The hand-held instrument of claim 12, said first switch terminal being connected to said anode conductor.

14. The hand-held instrument of claim 13, further including a remote anode electrode;

said second switch terminal being connected to said remote anode electrode.

15. The hand-held instrument of claim 14, said switch being actuable by a pushbutton carried externally on said handle.

16. The hand-held instrument of claim 12, said switch being a momentary contact, single-pole single-throw switch.

18. An instrument for monitoring or electrically stimulating exposed, subcutaneous tissue of a living body, comprising:

an elongate cathode conductor including a proximal end and a distal end having a distal end surface, said cathode conductor having sufficient resilience to resist bending when in operable contact with subcutaneous tissue, said cathode conductor having a diameter;

said cathode conductor being disposed within a first insulating sheath, said first sheath extending substantially to the cathode conductor distal end and leaving said cathode conductor distal end surface exposed;

said cathode conductor distal end surface defining a substantially planar distally exposed cathode tip;

an elongate anode conductor including a proximal end and a distal end having a distal end surface, said anode conductor having sufficient resilience to resist bending when in operable contact with subcutaneous tissue, said anode conductor having a diameter different from said diameter of said cathode conductor;

said anode conductor being disposed within a second insulating sheath, said second sheath extending substantially to the anode conductor distal end and leaving said anode conductor distal end surface exposed; and

said anode conductor distal end surface defining a substantially planar distally exposed anode tip, wherein said substantially planar distally exposed anode tip and said substantially planar distally exposed cathode tip are in a substantially coplanar flush distal tip configuration.

19. The instrument of claim 18, said cathode conductor including a selectively bendable malleable terminal portion proximate said distal end, said malleable portion adapted to resiliently retain a selected bent shape;

said anode conductor including a selectively bendable malleable terminal portion proximate said distal end, said malleable portion adapted to resiliently retain a selected bent shape; and

said cathode and anode conductors being disposed in a flexible jacket, said jacket extending over a selected fraction of the length of the cathode and anode malleable terminal portion and maintaining a selected spacing between said flush distal tips of said anode and cathode conductors.

20. The instrument of claim 18, said cathode conductor having a first diameter and said anode conductor having a second diameter larger than said first diameter.

21. An instrument for monitoring or electrically stimulating exposed, subcutaneous tissue of a living body, comprising:

an elongate cathode conductor including a wire having a proximal end and a distal end having a distal end surface, said wire of said cathode conductor having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

said wire of said cathode conductor being malleable along a selectively bendable malleable terminal portion proximate said distal end, said malleable terminal portion being adapted to resiliently retain a selected bent shape;

an elongate anode conductor including a wire having a proximal end and a distal end having a distal end surface, said wire of said anode conductor having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

said wire of said anode conductor being malleable along a selectively bendable malleable terminal portion proximate said distal end of said wire of said anode conductor, said malleable terminal portion of said anode conductor being adapted to resiliently retain a selected bent shape; and

said wires being sheathed in a flexible jacket, said jacket extending over a selected fraction of the length of said malleable terminal portions and maintaining a selected side by side spacing between said distal end surfaces of said wires.

22. The instrument of claim 21, said flexible jacket extending over four-fifths of said malleable terminal portions.

23. The instrument of claim 21, said wire of said cathode conductor having a first diameter and said wire of said anode conductor having a second diameter larger than said first diameter.

24. The instrument of claim 21, said wire of said cathode conductor carrying an insulating sheath having a first color and said wire of said anode conductor carrying an insulating sheath having a second color visually distinguishable from said first color.

25. The instrument of claim 21, said cathode conductor distal end surface defining a substantially planar exposed cathode tip and said anode conductor distal end surface defining a substantially planar exposed anode tip in a substantially coplanar, flush distal tip configuration with said cathode tip.

26. An instrument for monitoring or electrically stimulating exposed, subcutaneous tissue of a living body, comprising:

an elongate cathode conductor including a proximal end and a distal end having a distal end surface, said cathode conductor having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

an elongate anode conductor including a proximal end and a distal end having a distal end surface, said anode conductor having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

said cathode conductor having a first diameter and said anode conductor having a second diameter different than said cathode first diameter.

27. The instrument of claim 26, said anode conductor second diameter being larger than said cathode first diameter.

28. The instrument of claim 27, said anode conductor second diameter being approximately twice said cathode conductor first diameter.

29. The instrument of claim 27, said anode conductor second diameter being 24 AWG and said cathode conductor first diameter being 30 AWG.

30. The instrument of claim 26, said cathode conductor carrying an insulating sheath having a first color and said anode conductor carrying an insulating sheath having a second color visually distinguishable from said cathode insulating sheath first color.

31. The instrument of claim 26, said cathode conductor distal end surface defining a substantially planar exposed cathode tip and said anode conductor distal end surface defining a substantially planar exposed anode tip in a substantially coplanar, flush distal tip configuration with said cathode tip.

32. The instrument of claim 26, further including a bipolar electrical cord having first and second flexible conductors, said first flexible conductor having a first diameter and said second flexible conductor having a second diameter different than said first flexible conductor first diameter.

33. A hand-held instrument for monitoring or electrically stimulating exposed, subcutaneous tissue of a living body, comprising:

an elongate cannula having an open proximal end, an open distal end and a lumen there between;

a handle carried on said proximal end;

a flexible, non-conductive, elongate jacket projecting distally from said cannula distal end to terminate at a jacket distal end;

an elongate, flexible cathode conductor disposed within said jacket and extending distally from said cannula distal end to terminate at a cathode conductor distal end disposed distally of said jacket distal end, said cathode conductor distal end having a planar distal end surface, said cathode conductor being malleably deformable and having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

said cathode conductor being disposed within a first flexible insulating sheath extending distally from said jacket distal end to terminate substantially flush with said distal end of said cathode conductor, said first sheath leaving said cathode conductor planar distal end surface exposed;

an elongate, flexible anode conductor disposed within said jacket and extending distally from said cannula distal end to terminate at an anode conductor distal end disposed distally of said jacket distal end, said anode conductor distal end having a planar distal end surface, said anode conductor being malleably deformable and having sufficient resilience to resist bending when in operable contact with subcutaneous tissue; and

said anode conductor being disposed within a second flexible insulating sheath extending distally from said jacket distal end to terminate substantially flush with said distal end of said anode conductor, said second sheath leaving said anode conductor planar distal end surface exposed.

34. The hand-held instrument of claim 33, said anode conductor and said cathode conductor in said flexible jacket defining a malleable distal probe segment;

said malleable distal probe segment being plastically deformable to a selected angular position, wherein said malleable distal probe segment will, after deformation, resiliently maintain said selected angular position.

35. The hand-held instrument of claim 34, wherein said distal probe segment has a length in the range of one half inch to one inch.

36. The hand-held instrument of claim 35, wherein said length is three quarters of an inch.

37. The hand-held instrument of claim 33, said elongate cathode conductor having a first diameter.

38. The hand-held instrument of claim 37, said elongate anode conductor having a second diameter larger than said first diameter.

39. The hand-held instrument of claim 37, wherein said cathode and anode planar distal end surfaces lie in a plane disposed at an angle to the elongate cathode conductor axis.

40. The hand-held instrument of claim 39, wherein said plane is disposed at an angle fifteen degrees from normal to the elongate cathode conductor axis.

41. A hand-held instrument for monitoring or electrically stimulating exposed, subcutaneous tissue of a living body, comprising:

an elongate cannula having an open proximal end, an open distal end and a lumen there between;

a handle carried on said cannula proximal end;

an elongate, flexible, cathode conductor including a proximal end and a distal end having a substantially planar distal end surface, said cathode conductor being malleably deformable and having sufficient resilience to resist bending when in operable contact with subcutaneous tissue, said elongate cathode conductor having a first diameter;

said cathode conductor being disposed within a first flexible insulating sheath extending distally to and substantially flush with said distal end of said cathode conductor, said first sheath leaving said cathode conductor planar distal end surface exposed, said first sheath including a colored surface;

an elongate, flexible anode conductor including a proximal end and a distal end having a planar distal end surface, said anode conductor being malleably deformable and having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

said anode conductor being disposed within a second flexible insulating sheath extending distally to and substantially flush with said distal end of said anode conductor, said second sheath leaving said anode conductor planar distal end surface exposed;

said cathode conductor and said anode conductor being carried within an elongate non-conductive, flexible jacket having a distal end, wherein said cathode conductor distal end and said anode conductor distal end project distally beyond said jacket distal end; and

said flexible jacket, said cathode conductor and said anode conductor being carried within said cannula lumen, wherein said flexible jacket distal end, said cathode conductor distal end and said anode conductor distal end project distally beyond said cannula open distal end.

42. The hand-held instrument of claim 41, said first flexible insulating sheath including a black surface.

43. An instrument for monitory or electrically stimulating exposed, subcutaneous tissue of a living body, comprising:

an elongate cathode conductor including a proximal end and a distal end having a distal end surface, said cathode conductor having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

said cathode conductor being disposed within a first insulating sheath, said first sheath extending substantially to the cathode conductor distal end and leaving said cathode conductor distal end surface exposed, said first sheath having a first color;

said cathode conductor distal end surface defining a substantially planar distally exposed cathode tip;

an elongate anode conductor including a proximal end and a distal end having a distal end surface, said anode conductor having sufficient resilience to resist bending when in operable contact with subcutaneous tissue;

said anode conductor being disposed within a second insulating sheath, said second sheath extending substantially to the anode conductor distal end and leaving said anode conductor distal end surface exposed, said second sheath having a second color visually distinguishable from said first color; and

said anode conductor distal end surface defining a substantially planar distally exposed anode tip, wherein said substantially planar distally exposed anode tip and said substantially planar distally exposed cathode tip are in a substantially coplanar flush distal tip configuration.

44. A method for depolarization and stimulation of nerve tissue, providing repeatable stimulation with greater efficacy, comprising

a) providing an anode having a first selected wire diameter and a cathode with a second wire diameter smaller than said anode wire diameter, wherein the current density proximate the cathode conductive tip surface is greater than the current density proximate the anode tip;

and

b) stimulating the nerve tissue with said cathode and said anode.