Apparatus and method for locating a nerve

• US 5,775,331 A
• Filed: 06/07/1995
• Issued: 07/07/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Brigham and Women's Hospital Incorporated, UroMed Corporation
• Original Assignee: Brigham and Women's Hospital Incorporated, UroMed Corporation
• Inventors: Raymond, Stephen A., Coats, David E.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/484,390
• Time in Patent Office: 1,126 Days
• Field of Search: 128/741, 128/774, 128/782
• 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 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain

Abstract

An apparatus and method for stimulating and locating a nerve is described. The apparatus is closed-loop in nature in that the device is automated and is independent of the skill of the operator. The apparatus includes a stimulating probe having an array of electrodes, an automatic control means, and a response detecting means. Response feedback is analyzed according to an electrode selecting algorithm (incorporating a response interpreting algorithm) so that ongoing stimulation is restricted to a subset of the array which produces a criterion response with the least magnitude of stimulation. A method of use is also described. The device and method are also intended to permit optimal stimulation of a located nerve for therapeutic purposes.

Claims

1. An apparatus for stimulating and locating a nerve, comprising:

means for applying a stimulus to a plurality of sites within an area of tissue likely to contain the nerve to be located;

means for detecting a response to said stimulus;

means for automatically modifying the site of stimulation, said means for automatically modifying the site of stimulation including means for interpreting the response provided by said response detecting means; and

means for indicating the location of the nerve to the user;

wherein said modifying means automatically modifies the site of a stimulus applied to the area of tissue likely to contain the nerve based on an interpretation of the detected response by said interpreting means to further stimulate the nerve to determine its location.

2. The apparatus of claim 1, wherein said means for applying a stimulus to a plurality of sites within an area of tissue likely to contain the nerve to be located applies said stimulus transcutaneously.

3. The apparatus of claim 1, wherein said means for applying a stimulus comprises a probe for applying the stimulus to an operative site within the area of tissue likely to contain the nerve to be located.

4. The apparatus of claim 1, wherein said means for applying a stimulus to a plurality of sites within an area of tissue likely to contain the nerve to be located applies said stimulus to the plurality of sites via a natural body orifice.

5. The apparatus of claim 1, wherein said means for applying a stimulus to a plurality of sites within an area of tissue likely to contain the nerve to be located is a magnetic induction device capable of focusing a magnetic field to induce an electrical stimulating current.

6. The apparatus of claim 1, wherein said means for applying a stimulus to a plurality of sites within an area of tissue likely to contain the nerve to be located is an array of electrodes.

7. The apparatus of claim 1, wherein said means for applying a stimulus to a plurality of sites within an area of tissue likely to contain the nerve to be located is a patch comprising an array of electrodes.

8. The apparatus of claim 1, wherein said means for applying a stimulus to a plurality of sites within an area of tissue likely to contain the nerve to be located comprises an electrode movably positioned on a track.

9. The apparatus of claim 6, wherein said electrodes are arranged in a multi-dimensional configuration.

10. The apparatus of claim 6, wherein said array includes 20-50 electrodes.

11. The apparatus of claim 6, wherein said electrodes are spaced 0.1-4.0 mm apart.

12. The apparatus of claim 1 further comprising a stimulator circuit disposed in connection with said stimulus applying means for generating a stimulus comprising a train of multiple pulses.

13. The apparatus of claim 9, wherein said electrodes are activated in successive triplets to determine the longitudinal axis and symmetry of the nerve.

14. The apparatus of claim 1, wherein said modifying means further comprises:

memory for storing parameters of response states which correspond to successful and unsuccessful stimulation of the nerve, and recording means for recording and storing the response provided by said response detection means, wherein said interpreting means interprets data received from said response detection means and stored in said recording means, and wherein said interpreting means discriminates between states corresponding to periods of successful stimulation and states corresponding to periods of unsuccessful stimulation by comparing the response provided by said response detection means with the parameters stored in said memory.

15. The apparatus of claim 1, wherein said modifying means is a microprocessor comprising:

memory for storing parameters of response states which correspond to successful and unsuccessful stimulation of the nerve; and

recording means for recording and storing the response provided by said response detection means,

wherein said microprocessor is coupled to said stimulus applying means by a first coupling means and said microprocessor is coupled to said response detecting means by a second coupling means.

16. The apparatus of claim 1, wherein said modifying means further comprises memory for storing an electrode selecting algorithm and said modifying means modifies subsequent application of the stimulus applied by said stimulus applying means in accordance with said electrode selecting algorithm.

17. The apparatus of claim 1, wherein said stimulus applying means is a probe used intraoperatively.

18. The apparatus of claim 1, wherein said means for detecting a response to a stimulus is an ultrasonic density gauge.

19. An apparatus for stimulating and locating the cavernosal nerve, comprising:

a stimulator circuit for generating a stimulus;

a probe disposed in connection with said stimulator circuit, said probe having a handle portion and a stimulating tip for applying a stimulus to an area of tissue likely to contain the nerve to be located, said stimulating tip comprising an array of electrodes;

a control means for governing activation of said array of electrodes, said control means comprising;

memory for storing an electrode selecting algorithm which activates the electrodes of said array based on an evaluation of a change in a tumescence response to successful stimulation of the cavernosal nerve; and

means for employing the electrode selecting algorithm; and

a response detection means for detecting and measuring a tumescence response, wherein said response detection means provides tumescence response information to said control means for evaluation by said electrode selecting algorithm to further stimulate the nerve to determine its location.

20. The apparatus of claim 19, wherein said stimulator circuit generates a stimulus comprising a train of pulses.

21. The apparatus of claim 19, wherein said electrodes are spaced 1.0 mm apart.

22. The apparatus of claim 19, wherein said array of electrodes comprises 4-16 electrodes.

23. The apparatus of claim 19, wherein said response detection means is a tumescence monitor comprising distensible tubing filled with a conductive fluid in electrical contact with said control means.

24. The apparatus of claim 19, wherein said stimulator circuit generates a stimulus having parameters which range between 0.5-25 mA, 100-2000 μ

s, 4-50 Hz.

25. The apparatus of claim 19 further comprising a suction port for the removal of bodily fluids from the surgical field.

26. The apparatus of claim 19, further comprising a filter to isolate the change in the tumescence response from changes induced by surgical intervention while locating the nerve with the apparatus.

27. The apparatus of claim 19, wherein said probe includes a longitudinal axis and the most distal electrode of said array is angled at approximately 45°

with respect to the longitudinal axis of said probe to position the most distal electrode below the prostate gland or urethra of a patient.

28. The apparatus of claim 19, wherein said handle of said probe is flexible to enable positioning of the probe within the body tissue.

29. The apparatus of claim 19, wherein said apparatus further includes a means for indicating the location of the nerve to the user.

30. An apparatus for locating and optimally stimulating a nerve, comprising:

an implant comprising an array of electrodes for delivering a stimulus to a nerve;

a control means for governing activation of said electrodes of said array, said array of electrodes being activated in accordance with an electrode selecting algorithm which evaluates a response to successful stimulation of the nerve; and

a response detection means for detecting and measuring a response, said response detection means providing response feedback information to said control means for evaluation by said electrode selecting algorithm.

31. The apparatus of claim 30, wherein said electrodes are positioned in a multi-dimensional formation.

32. The apparatus of claim 30, wherein said electrodes are spaced 0.1-4.0 mm apart.

33. The apparatus of claim 30, wherein a selected subset of said electrodes are determined to be near the nerve and are activated in rapid sequence to optimally stimulate the nerve.

34. The apparatus of claim 30, wherein said nerve is the cavernosal nerve.

35. The apparatus of claim 30, wherein said implant is a stent inserted within a natural body cavity of the patient.

36. The apparatus of claim 34, wherein said response detection means is a tumescence monitor.

37. A method for stimulating the cavernosal nerve comprising the step of:

applying a stimulus, said stimulus being capable of initiating sub-maximal tumescence of the penis such that subsequent tumescence responses to subsequently applied stimuli occur with shorter delay from the onset of successful stimulation.

38. The method of claim 37, wherein said stimulus is a train of electrical pulses.

39. The method of claim 38, wherein the parameters of said stimulus are within the range of 0.5-25 mA, 100-2000 μ

s, 4-50 Hz.

40. The method of claim 38, wherein said stimulus is applied to the nerve by a probe having an array of electrodes.

41. The method of claim 40, wherein said array comprises 4-16 electrodes.

42. The method of claim 37, wherein said stimulus is a drug capable of evoking a tumescence response.

43. The method of claim 42, wherein said drug is papaverine.

44. The method of claim 37, wherein said stimulus is a vibrating pulse.

45. A method for stimulating and locating the cavernosal nerve, comprising the steps of:

(a) applying a stimulus to a tissue site likely to contain the nerve to be located to evoke a tumescence response, the stimulus having an intensity known to stimulate the nerve when the site of stimulation is within a known distance from the nerve;

(b) detecting a tumescence response to stimulation of the nerve;

(c) evaluating the tumescence response to stimulation of the nerve; and

(d) automatically modifying the site of subsequent stimulation based on the evaluation of the tumescence response to further stimulate the nerve to determine its location.

46. The method of claim 45, wherein said applying step comprises the step of generating a stimulus of an intensity known to stimulate the cavernosal nerve when the site of stimulation is within 1 mm of the nerve.

47. The method of claim 45 further comprising the step of repeating steps (a)-(d) until localization of the nerve is achieved.

48. The method of claim 47 further comprising the step of indicating to the user the location of the nerve.

49. The method of claim 45, wherein said applying step is performed by a probe having an array of electrodes.

50. The method of claim 45, wherein said applying step is performed by an implant having an array of electrodes positioned in a multi-dimensional arrangement.

51. The method of claim 50, wherein said applying step further comprises the step of activating the electrodes of said implant in successive triplets to determine the longitudinal axis of the nerve to optimally stimulate the nerve.

52. The method of claim 45, wherein said applying step comprises the step of generating a stimulus comprising a current pulse of 0.5-25 mA.

53. The method of claim 45, wherein said applying step comprises the step of generating a stimulus comprising a train of pulses.

54. The method of claim 45, wherein said detecting step is performed by a tumescence monitor which detects successful stimulation of the cavernosal nerve.

55. The method of claim 54, wherein said evaluating step is performed by a response interpreting means which interprets a change in the tumescence response.

56. The method of claim 49, wherein said modifying step is performed by a modifying means comprising a memory which automatically modifies the site of stimulation among the electrodes of said array in accordance with an electrode selecting algorithm stored in said memory.

57. The method of claim 45 further comprising the step of priming the nerve by applying a stimulus to the nerve, said stimulus being capable of initiating sub-maximal tumescence of the penis such that subsequent tumescence responses to subsequently applied stimuli occur with shorter delay from the onset of successful stimulation, and

wherein said priming step is performed prior to step (a).

58. A method for locating a nerve, comprising the steps of:

(a) applying a stimulus to a tissue site likely to contain the nerve to be located;

(b) detecting a response to stimulation of the nerve;

(c) evaluating the response to successful stimulation of the nerve; and

(d) automatically modifying the site of subsequent stimulation based on the evaluation of the response to further stimulate the nerve to determine its location.

59. The method of claim 58, wherein said applying step comprises the step of generating a stimulus of an intensity known to stimulate the nerve when the site of stimulation is within a known distance from the nerve.

60. The method of claim 58 further comprising the step of repeating said steps (a)-(d) until localization of the nerve is achieved.

61. The method of claim 60, further comprising the step of indicating to the user the location of the nerve.

62. The method of claim 58, wherein said applying step is performed by an instrument including an array of electrodes.

63. The method of claim 58, wherein said modifying step is performed by a modifying means which automatically modifies the site of stimulation in accordance with a site selecting algorithm which is based on information provided by a response detecting means and stimulation input means.

64. An apparatus for locating a nerve, comprising:

a source of electricity;

a stimulus applying means coupled to said source of electricity for applying a stimulus to an area of tissue likely to contain the nerve to be located, said stimulus applying means including an array of electrodes;

means for detecting a response to said stimulus;

means for varying activation of the electrodes of said array; and

indicating means for indicating location of the nerve to the user,

wherein said activation means varies activation of the electrodes of said array based on the detected response to the stimulus applied by said stimulus applying means to further stimulate the nerve to determine its location.

65. A method for stimulating and locating the cavernosal nerve, comprising the steps of:

(a) applying a low intensity stimulus to a tissue site likely to contain the nerve to evoke a sub-maximal tumescence response, said stimulus having an intensity known to stimulate the nerve when the site of stimulation is within a minimal distance from the nerve;

(b) detecting a tumescence response to stimulation of the nerve;

(c) evaluating the differential of the tumescence response to stimulation of the nerve;

(d) automatically modifying the site of subsequent stimulation based on the evaluation of the differential of the tumescence response to further stimulate the nerve to determine its location.

66. The method of claim 65 further comprising the step of repeating steps (a)-(d) until localization of the nerve is achieved.

67. The method of claim 66, further comprising the step of indicating to the user the location of the nerve.

68. The method of claim 65, wherein said applying step is performed by an array of electrodes, each electrode of said array having a diameter less than 2 mm.

69. An apparatus for stimulating and locating a nerve, comprising:

means for applying a stimulus to a plurality of sites within an area of tissue likely to contain the nerve to be located;

means for detecting and measuring a response to said stimulus;

means for automatically modifying the site of stimulation within the area of tissue likely to contain the nerve to be located;

means for determining the location of the nerve to be located, wherein said means for determining the location of the nerve evaluates the responses elicited by application of a stimulus to each of said plurality of sites to determine the location of the nerve; and

means for indicating the location of the nerve to the operator.

70. The apparatus of claim 69, wherein said applying means is a probe.

71. The apparatus of claim 70, wherein said probe comprises an array of electrodes.

72. The apparatus of claim 71 further comprising memory and wherein said modifying means automatically modifies the site of stimulation by activating said array of electrodes in accordance with a predefined electrode activating program stored in said memory.

73. The apparatus of claim 72, wherein said array comprises 8 electrodes.

74. The apparatus of claim 69, wherein the nerve to be located is the cavernosal nerve and said means for detecting and measuring a response is a tumescence monitor.

75. The apparatus of claim 69, wherein said modifying means automatically modifies the site of stimulation in accordance with a predefined program.

76. The apparatus of claim 75 further comprising memory for storing said predefined program for automatically modifying the site of stimulation.

77. The apparatus of claim 76, wherein said memory contains at least one predefined program.

78. The apparatus of claim 69 further comprising recording means for recording and storing the responses provided by said response detecting and measuring means and wherein the differential of the responses stored in said recording means is evaluated and compared by said location determining means.

79. A method for locating a nerve, comprising the steps of:

(a) applying a stimulus to a site within an area of tissue likely to contain the nerve to be located;

(b) detecting a response to stimulation of the nerve;

(c) measuring the detected response; and

(d) automatically modifying the site of subsequent stimulation in accordance with a predefined site selecting program.

80. The method of claim 79 further comprising the steps of:

(e) applying a subsequent stimulus to the tissue site as modified in accordance with said predefined site selecting program;

(f) detecting a response to the subsequent stimulus; and

(g) comparing the differential of the detected responses to determine the location of the nerve.

81. The method of claim 80 further comprising the step of:

(h) repeating steps (a)-(g).

82. The method of claim 81 further comprising the step of:

(i) indicating the location of the nerve to the operator.

83. The method of claim 80 further comprising the step of:

(h) indicating the location of the nerve to the operator.

84. The method of claim 79, wherein said applying step is performed by an array of electrodes positioned on a probe.

85. The method of claim 84, wherein the nerve to be located is the cavernosal nerve and wherein said detecting step is performed by a tumescence monitor.

86. The method of claim 79, wherein said modifying step is performed by a modifying means comprising memory for storing said predefined site selecting program.

87. An apparatus for stimulating and locating a nerve, comprising:

means for applying a stimulus to a plurality of sites within an area of tissue likely to contain the nerve to be located;

means for detecting and measuring a response to said stimulus;

means for determining the location of the nerve to be located, wherein said means for determining the location of the nerve evaluates the responses elicited by application of a stimulus to each of said plurality of sites within the area of tissue likely to contain the nerve to determine the location of the nerve; and

means for indicating the location of the nerve to the user.

88. The apparatus of claim 87, wherein said applying means is a probe comprising at least one electrode.

89. The apparatus of claim 87, wherein the nerve to be located is the cavernosal nerve and said means for detecting and measuring a response is a tumescence monitor.

90. The apparatus of claim 87 further comprising recording means for recording and storing the responses provided by said response detecting and measuring means and wherein the differential of the responses stored in said recording means is evaluated and compared by said location determining means.

91. A method for locating a nerve, comprising the steps of:

(a) applying a stimulus to a site within an area of tissue likely to contain the nerve to be located;

(b) detecting a response to stimulation of the nerve;

(c) measuring the detected response;

(d) modifying the site of subsequent stimulation;

(e) applying a subsequent stimulus to the modified site of stimulation; and

(f) evaluating the detected responses elicited by application of a stimulus to each of the stimulation sites to determine the location of the nerve.

92. The method of claim 91 further comprising the step of:

(g) repeating steps (a)-(f).

93. The method of claim 92 further comprising the step of:

(h) indicating the location of the nerve.

94. The method of claim 91 further comprising the step of:

(g) indicating the location of the nerve.

95. The method of claim 91, wherein said applying step is performed by an array of electrodes positioned on a probe.

96. The method of claim 95, wherein said modifying step is performed automatically by a modifying means comprising memory for storing a predefined site selecting program and wherein the electrodes of said array are activated in accordance with said site selecting program.

97. The method of claim 91, wherein the nerve to be located is the cavernosal nerve and wherein said detecting step is performed by a tumescence monitor.

98. The method of claim 91, wherein said applying step is performed by a single electrode positioned on a probe.

99. The method of claim 98, wherein said modifying step is performed manually.