Bi-level charge pulse apparatus to facilitate nerve location during peripheral nerve block procedures

• US 6,325,764 B1
• Filed: 11/10/1997
• Issued: 12/04/2001
• Est. Priority Date: 08/05/1996
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Newell, Jonathan C., Messina, Ralph F., Griffith, Richard Lee, Houghton, Frederick Charles, Edic, Peter M., Strowe, Robert J.
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US08/967,054
• Time in Patent Office: 1,485 Days
• Field of Search: 600/546, 600/554, 600/373, 600/548, 606/36, 606/44, 607/116
• US Class Current: 600/554
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: Y10S 977/864 Electrostatic force probe
• CPC Class Codes: Y10S 977/875 with tip detail

Abstract

A self-contained electrolocation apparatus of the present invention includes an electrically conducting needle cannula having a proximal end, a distal end and a hollow bore therethrough. The invention further includes a non-conductive tube having a proximal end and a distal end, the tube being mounted over the needle cannula so that the distal end of the non-conductive tube is proximal to the distal end of the needle cannula. The non-conductive tube has a conductive layer thereon, whereby the needle cannula and the conductive layer respectively define first and second conductors coaxially spaced from one another by the non-conductive tube. There is a grip fixedly attached to the needle cannula for manipulating the apparatus. The grip has an electrical stimulus generator circuit within it that is electrically connected to the first conductor and the second conductor. The stimulus generator circuit is capable of applying a potential across the conductors so that when the needle is positioned in a patient'"'"'s tissue and the electrical stimulus generator circuit is activated, the potential is sufficient to induce a preselected current thereby providing a charge pulse between the distal end of the conductive layer and the distal end of said needle cannula through the patient'"'"'s tissue. The charge pulse is sufficient to induce a twitch response in the patient.

Claims

1. A self-contained electrolocation apparatus comprising:

an electrically conducting needle cannula having a proximal end, a distal end and a hollow bore therethrough;

a non-conductive tube having a proximal end and a distal end, said tube mounted over said needle cannula so that said distal end of said non-conductive tube is proximal to said distal end of said needle cannula;

a conductive layer having a distal end on said non-conductive tube, whereby said needle cannula and said conductive layer respectively define first and second conductors coaxially spaced from one another by said non-conductive tube;

a grip fixedly attached to said needle cannula for manipulating said apparatus; and

an electrical stimulus generator circuit within said grip and electrically connected to said first conductor and said second conductor, said stimulus generator being capable of applying a potential across said conductors so that when said needle is positioned in a patient'"'"'s tissue and said electrical stimulus generator circuit is activated, said potential is sufficient to induce a preselected current thereby providing a charge pulse between said distal end of said conductive layer and said distal end of said needle cannula through the patient'"'"'s tissue, said charge pulse being sufficient to induce a twitch response in the patient.

2. The electrolocation apparatus of claim 1 wherein said electrical stimulus generator circuit comprises a microprocessor.

3. The electrolocation apparatus of claim 2 wherein said electrical stimulus generator circuit provides said preselected charge pulses in at least one preselected repeatable pattern in at least one operating mode.

4. The electrolocation apparatus of claim 3 wherein said electrical stimulus generator circuit provides a plurality of repeatable patterns in a plurality of operating modes.

5. The electrolocation apparatus of claim 4 wherein said stimulus generator circuit further comprises an input device accessible by a practitioner'"'"'s finger pressure thereby allowing the practitioner to select one of said operating modes.

6. The electrolocation apparatus of claim 5 wherein said input device is a momentary contact switch.

7. The electrolocation apparatus of claim 6 wherein said momentary contact switch allows the practitioner to select sequentially from three preselected patterns of charge pulses and one quiescent mode.

8. The electrolocation apparatus of claim 7 wherein said preselected patterns include charge pulses of different currents.

9. The electrolocation apparatus of claim 8 wherein said currents associated with said charge pulses within one preselected pattern are constant.

10. The electrolocation apparatus of claim 9 wherein said preselected constant currents are between about 0.1 milliamps to about 2 milliamps.

11. The electrolocation apparatus of claim 10 wherein said preselected patterns include pulses of different durations.

12. The electrolocation apparatus of claim 11 wherein said durations of said pulses are between about 50 microseconds and 1,000 microseconds.

13. The electrolocation apparatus of claim 12 wherein said preselected pattern of charge pulses includes preselected time intervals between said pulses.

14. The electrolocation apparatus of claim 13 wherein said preselected time intervals are between about 0.25 seconds to about 2.0 seconds.

15. The electrolocation apparatus of claim 2 wherein said stimulus generator circuit includes means for ensuring that said electrolocation apparatus, once used for a procedure, is substantially prevented from being used for more than a preselected time period;

and said time period being sufficient for a practitioner to complete one procedure, thereby rendering said electrolocation apparatus substantially single-use.

16. The electrolocation apparatus of claim 15 wherein said means for ensuring that said electrolocation apparatus once used for a procedure is substantially prevented from being used for more than a preselected total operating time period comprises progrannning said microprocessor to direct said potential to a radiative element after said preselected total operating time has elapsed until said potential is substantially depleted.

17. The electrolocation apparatus of claim 1 wherein said electroconductive cannula projects proximally beyond said grip and includes a connector for connecting a medication delivery device to said bore of said electroconductive needle.

18. The electrolocation apparatus of claim 17 wherein said connector further includes a flexible tube.

19. The electrolocation apparatus of claim 1 wherein said stimulus generator circuit further comprises an indicator of said charge pulse.

20. The electrolocation apparatus of claim 19 wherein said indicator fiurther comprises a transducer to produce a sound audible to the practitioner using said apparatus.

21. The electrolocation apparatus of claim 19 wherein said indicator further comprises a radiative element to produce a light emission visible to a practitioner using said apparatus.

22. The electrolocation apparatus of claim 1 wherein said stimulus generator circuit further comprises a battery.

23. The electrolocation apparatus of claim 22 wherein said battery has a maximum potential of about three volts.

24. The electrolocation apparatus of claim 23 wherein said stimulus generator circuit further comprises a voltage doubler circuit to provide about six volts maximum potential between said first conductor and said second conductor.

25. The electrolocation apparatus of claim 1 wherein said stimulus generator circuit is always operating once powered thereby providing a substantially inherently safe circuit, and further comprises a sleep mode having a minimum power draw so that said apparatus has a shelf life substantially limited by a shelf life of the battery.

26. The electrolocation apparatus of claim 1 being sealed in a package formed from a material substantially resistant to the passage of microorganisms and exposed to conditions rendering any microorganisms therein substantially non-viable, thereby providing said apparatus in a substantially sterile state until said package is opened.

27. A self-contained electrolocation apparatus comprising:

an electrically conducting needle cannula having a proximal end, a distal end and a hollow bore therethrough;

a non-conductive tube having a proximal end and a distal end, said tube mounted over said electroconductive needle so that said distal end of said non-conductive tube is proximal to said distal end of said needle cannula;

a conductive layer on said non-conductive tube whereby said needle cannula and said conductive layer respectively define first and second conductors coaxially spaced from one another by said non-conductive tube;

a grip fixedly attached to said needle cannula for manipulating said apparatus; and

an electrical stimulus generator circuit including a battery within said grip and electrically connected to said first conductor and said second conductor, said stimulus generator circuit including an input device accessible by a practitioner'"'"'s finger pressure to select an operating mode from a plurality of operating modes of said stimulus generator circuit, said stimulus generator being capable of applying a potential across said conductors sufficient to generate charge pulses, said circuit further including indications visible and audible to a practitioner of said preselected charge pulses, so that when said needle is positioned in a patient'"'"'s tissue the practitioner can initiate and terminate one of said patterns of charge pulses and is informed of the status of said generator circuit, and wherein said charge pulses are sufficient to induce preselected constant currents between said distal end of said conductive layer and said distal end of said conductive needle through the patient'"'"'s tissue, said currents being sufficient to induce a twitch response in the patient.

28. An electrolocation apparatus comprising:

an electrically conducting needle cannula having a proximal end, a distal end and a hollow bore therethrough; and

an electrical stimulus generator circuit electrically connected to the needle for generating charge pulses of electrical energy alternating between high and low charge pulses, wherein the alternating charge pulses are generated by varying the time duration of the pulses.

29. The electrolocation apparatus of claim 28, wherein the charge pulses are approximately constant.

30. The electrolocation apparatus of claim 29, wherein the time duration of the low charge pulse is between about 95 to 150 microseconds.

31. The electrolocation apparatus of claim 30, wherein the time duration of the high charge pulse is between about 375 to 600 microseconds.

32. An electrolocation apparatus comprising:

an electrically conducting needle cannula having a proximal end, a distal end and a hollow bore therethrough; and

an electrical stimulus generator circuit electrically connected to the needle for generating charge pulses of electrical energy alternating between high and low charge pulses, wherein the alternating change pulses are generated by varying the current level of the charge pulses.

33. The electrolocation apparatus of claim 32, wherein the time duration of the charge pulses are approximately the same duration.

34. The electrolocation apparatus of claim 33, wherein the low current pulses are less than or equal to about 0.2 mA.

35. The electrolocation apparatus of claim 34, wherein the high current pulses are greater than or equal to about 0.5 mA.

36. The electrolocation apparatus of claim 33, wherein the pulses are of the same duration and generated at approximately uniform intervals.

37. The electrolocation apparatus of claim 36, wherein the duration of the pulses is between about 0.1 to 0.2 milliseconds and the pulse intervals are between about 0.25 to 2.0 seconds.

38. A method of locating a nerve comprising the steps of:

providing an electrically conducting needle cannula having a proximal end, a distal end and a hollow bore therethrough;

inserting the needle into a patient and towards the nerve; and

alternatively generating charge pulses of electrical energy alternating between high and low charge pulses for stimulating the nerve and generating muscle twitches.

39. The method of claim 38, wherein the alternating charge pulses are generated by varying the time duration of the charge pulses.

40. The method of claim 39, wherein the time duration of the low charge pulse is between about 95 to 150 microseconds.

41. The method of claim 40, wherein the time duration of the high charge pulse is between about 375 to 600 microseconds.

42. The method of claim 38, wherein the alternating charge pulses are generated by varying the current level of the charge pulses.

43. The method of claim 42, wherein the time duration of the charge pulses is approximately the same duration.

44. The method of claim 43, wherein the low current pulses are less than or equal to about 0.2 mA.

45. The method of claim 44, wherein the high current pulses are greater than or equal to about 0.5 mA.

46. The method of claim 45, wherein the pulses are of the same duration and generated at approximately uniform intervals.

47. The method of claim 46, wherein the duration of the pulses is between about 0.1 to 0.2 milliseconds and the pulse intervals is between about 0.25 to 2.0 seconds.

48. The method of claim 38, further comprising the step of moving needle towards a targeted nerve wherein the muscle twitches elicited by the alternating charges become substantially indistinguishable.