Method and apparatus for reduction of pain from electric shock therapies

• US 6,091,989 A
• Filed: 09/14/1998
• Issued: 07/18/2000
• Est. Priority Date: 04/08/1998
• Status: Expired due to Term

• Current Assignee: Imperception, Inc.
• Original Assignee: Imperception, Inc.
• Inventors: Brewer, James E., Swerdlow, Neal R., Swerdlow, Charles D.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/152,382
• Time in Patent Office: 673 Days
• Field of Search: 607/63, 607/5
• US Class Current: 607/5
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/395 for treating atrial fibrillation
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

A method and apparatus for pretreating a patient prior to a therapeutic painful stimulus, comprising the application of pain inhibiting stimuli to a patient prior to an application of the therapeutic painful stimulus. Applying pain inhibiting stimuli comprises the steps of sensing a need for the therapeutic painful stimulus, preparing to deliver the pain inhibiting stimuli to the patient prior to applying the therapeutic painful stimulus, and delivering the pain inhibiting stimuli to the patient prior to applying the therapeutic painful stimulus. The method and apparatus are embodied in modem, fully automatic, fully implantable, single or dual chamber atrial or ventricular cardioverter-defibrillators. The pain inhibiting prepulse method is intended primarily for use in conscious patients but may also be used in sleeping patients.

Claims

1. A therapeutic method, comprising the steps of applying a patient-perceptible preceding stimulus to a patient'"'"'s body and subsequently applying a painful therapeutic stimulus to the patient'"'"'s body, wherein said preceding stimulus comprises electrical stimulation initiated within a predetermined time period of 20-500 milliseconds prior to the painful therapeutic stimulus and having an amplitude of at least 10 volts, whereby the patient perceives pain associated with said painful therapeutic stimulus as being reduced and/or the patient physiologically responds to said painful therapeutic stimulus at a reduced level.

2. The method of claim 1, wherein said step of applying said electrical preceding stimulus comprises delivering said electrical preceding stimulus at an amplitude of 1000 volts or less.

3. The method of claim 2, wherein said step of applying said electrical preceding stimulus comprises delivering said electrical preceding stimulus at an amplitude of 100 volts or less.

4. The method of claim 1, wherein said painful therapeutic stimulus is an electrical painful stimulus and wherein said electrical preceding stimulus is monophasic and said electrical painful therapeutic stimulus is monophasic.

5. The method of claim 1, wherein said painful therapeutic stimulus is an electrical painful stimulus and wherein said electrical preceding stimulus is biphasic and said electrical painful therapeutic stimulus is monophasic.

6. The method of claim 1, wherein said painful therapeutic stimulus is an electrical painful stimulus and wherein said electrical preceding stimulus is monophasic and said electrical painful therapeutic stimulus is biphasic.

7. The method of claim 1, wherein said painful therapeutic stimulus is an electrical painful stimulus and wherein said electrical preceding stimulus is biphasic and said electrical painful therapeutic stimulus is biphasic.

8. The method of claim 1, wherein said preceding stimulus is a relatively small electrical shock applied to the patient prior to applying a relatively large electrical shock as said painful therapeutic stimulus to treat said patient'"'"'s arrhythmia.

9. The method of claim 1, wherein said painful therapeutic stimulus is a painful electrical stimulus, further comprising the steps, conducted prior to applying said preceding stimulus and said painful therapeutic stimulus, of:

(a) preparing a first energy source and circuitry to deliver said therapeutic painful electrical stimulus; and

(b) preparing a second energy source and circuitry to deliver said preceding electrical stimulus.

10. The method of claim 9, wherein said step of preparing said first energy source and circuitry occurs simultaneously with said step of preparing said second energy source and circuitry.

11. The method of claim 9, wherein said first energy source and circuitry and said second energy source and circuitry are unitary, whereby said electrical preceding stimulus is delivered using the same energy source and circuitry as said electrical painful therapeutic stimulus.

17. The method of claim 1 or claim 12 or claim 16, wherein said predetermined time period is between 50 and 250 milliseconds prior to the painful therapeutic stimulus.

18. The method of claim 1 or claim 12 or claim 16, wherein said step of applying said preceding stimulus comprises delivering said preceding stimulus for a duration from 0.1 millisecond to 25 milliseconds.

19. The method of claim 18, wherein said step of applying said preceding stimulus comprises delivering said preceding stimulus for a duration from 1 millisecond to 10 milliseconds.

20. The method of claim 1 or claim 12 or claim 16, wherein said preceding stimulus is applied to a first body part and wherein said painful therapeutic stimulus is applied to a second, distinct, body part.

21. The method of claim 1 or claim 12 or claim 16 wherein said preceding stimulus and said painful therapeutic stimulus are applied to the same body part.

22. The method of claim 1 or claim 12 or claim 16, wherein said preceding stimulus is applied to at least one first body part selected from the group of the patient'"'"'s body parts consisting of the heart, a blood vessel, an ear, at least one skeletal muscle, a bone, and at least one nerve.

23. The method of claim 1 or claim 12 or claim 16, wherein said painful therapeutic stimulus is applied to at least one second body part selected from the group of the patient'"'"'s body parts consisting of the heart, at least one skeletal muscle, and a blood vessel.

24. The method of claim 23, wherein said at least one second body part includes at least one atrium of the patient'"'"'s heart.

25. The method of claim 23, wherein said at least one second body part includes the patient'"'"'s superior vena cava.

26. The method of claim 23, wherein said at least one second body part includes at least one ventricle of the patient'"'"'s heart.

27. The method of claim 1 or claim 12 or claim 16, wherein said painful therapeutic stimulus comprises an electrical shock for treatment of an atrial or ventricular tachyarrhythmia in the patient.

28. The method of claim 27, wherein said preceding stimulus is synchronous with an electrical signal which is simultaneous with the QRS complex of an electrocardiogram of the patient.

29. The method of claim 1 or claim 12 or claim 16, wherein said preceding stimulus and said painful therapeutic stimulus have the same sensory modality.

30. The method of claim 1 or claim 12 or claim 16, wherein said step of applying said preceding stimulus and said painful therapeutic stimulus have different sensory modalities.

31. The method of claim 1 or claim 12 or claim 16, wherein said step of applying said preceding stimulus includes at least one first stimulus which has a sensory modality which is the same as that of said painful therapeutic stimulus and at least one second stimulus which has a different sensory modality than that of said painful therapeutic stimulus.

33. The method of claim 1 or claim 12 or claim 16, further comprising the step of administering a predetermined medication which is pharmacologically effective at enhancing said reduction in pain the patient perceives associated with said painful therapeutic stimulus and/or at enhancing said reduction in the patient'"'"'s physiological response to said painful therapeutic stimulus due to said preceding stimulus, prior to said step of applying a preceding stimulus.

12. A therapeutic method, comprising the steps of applying a patient-perceptible preceding stimulus to a patient'"'"'s body and subsequently applying a painful therapeutic stimulus to the patient'"'"'s body, wherein said preceding stimulus includes an auditory stimulus initiated within a predetermined time period of 20-500 milliseconds prior to the painful therapeutic stimulus, whereby the patient perceives pain associated with said painful therapeutic stimulus as being reduced and/or the patient physiologically responds to said painful therapeutic stimulus at a reduced level.

13. The method of claim 12, wherein said step of applying said auditory preceding stimulus comprises delivering said auditory preceding stimulus at an intensity from 0.1 dB(A) to 100 dB(A) above an existing ambient noise level.

14. The method of claim 13, wherein said step of applying said auditory preceding stimulus further comprises delivering said auditory preceding stimulus at an intensity from 5 dB(A) to 15 dB(A) above said existing ambient noise level.

15. The method of claim 12, wherein said preceding stimulus is an auditory prepulse adapted to be audible by said patient prior to applying a relatively large electrical shock as said painful therapeutic stimulus to treat said patient'"'"'s arrhythmia.

16. A therapeutic method, comprising the steps of applying a patient-perceptible preceding stimulus to a patient'"'"'s body and subsequently applying a painful therapeutic stimulus to the patient'"'"'s body, wherein said preceding stimulus includes a vibro-tactile stimulus initiated within a predetermined time period of 20-500 milliseconds prior to the painful therapeutic stimulus, whereby the patient perceives pain associated with said painful therapeutic stimulus as being reduced and/or the patient physiologically responds to said painful therapeutic stimulus at a reduced level.

32. The method of claim 16, wherein said preceding stimulus is a vibro-tactile prepulse adapted to be felt by said patient prior to applying a relatively large electrical shock as said painful therapeutic stimulus to treat said patient'"'"'s arrhythmia.

34. A medical therapeutic apparatus, comprising:

(a) at least one transmission element adapted for connection to a patent'"'"'s body;

(b) a pulse generator coupled to said at least one transmission element; and

(c) a controller coupled to said pulse generator and to said at least one transmission element for applying, via said at least one transmission element, a patient-perceptible preceding stimulus to the patient'"'"'s body and for applying, via said at least one transmission element, a painful therapeutic stimulus to the patient'"'"'s body after application of said preceding stimulus, wherein said preceding stimulus includes electrical stimulation initiated within a predetermined time period of 20-500 milliseconds prior to the painful therapeutic stimulus and having an amplitude of at least 10 volts, whereby the patient perceives pain associated with said painful therapeutic stimulus as being reduced and/or the patient physiologically responds to said painful therapeutic stimulus at a reduced level.

35. The apparatus of claim 34, wherein said preceding stimulus includes an electrical stimulus and said at least one transmission element includes an electrode.

36. The apparatus of claim 34, wherein said preceding stimulus is applied to the patient'"'"'s body for a duration from 0.1 millisecond to 25 milliseconds.

37. The apparatus of claim 34, wherein said preceding stimulus is a relatively small electrical shock applied to the patient prior to applying a relatively large electrical shock as said painful therapeutic stimulus to treat said patient'"'"'s arrhythmia.

38. The apparatus of claim 37, wherein said electrical preceding stimulus is monophasic and said electrical painful therapeutic stimulus is monophasic.

39. The apparatus of claim 37, wherein said electrical preceding stimulus is biphasic and said electrical painful therapeutic stimulus is monophasic.

40. The apparatus of claim 37, wherein said electrical preceding stimulus is monophasic and said electrical painful therapeutic stimulus is biphasic.

41. The apparatus of claim 37, wherein said electrical preceding stimulus is biphasic and said electrical painfull therapeutic stimulus is biphasic.

42. The apparatus of claim 34, wherein said painful therapeutic stimulus is an electrical painful therapeutic stimulus and wherein said pulse generator includes:

(a) a first energy source for applying said electrical painful therapeutic stimulus; and

(b) a second energy source for applying said preceding electrical stimulus.

43. The apparatus of claim 42, wherein said first energy source is activated simultaneously with activating said second energy source.

44. The apparatus of claim 42, wherein said first energy source and said second energy source are unitary, whereby said electrical preceding stimulus is delivered using the same energy source and circuitry as said electrical painful therapeutic stimulus.

52. The apparatus of claim 34 or claim 47 or claim 51, wherein said predetermined time period is between 50 and 250 milliseconds.

53. The apparatus of claim 34 or claim 47 or claim 51, wherein said preceding stimulus is applied to the patient'"'"'s body for a duration from 1 millisecond to 10 milliseconds.

54. The apparatus of claim 34 or claim 47 or claim 51, wherein said electrical preceding stimulus is applied to the patient'"'"'s body at an amplitude of 1000 volts or less.

55. The apparatus of claim 54, wherein said electrical preceding stimulus is applied to the patient'"'"'s body at an amplitude of 100 volts or less.

56. The apparatus of claim 34 or claim 47 or claim 51, wherein said preceding stimulus is applied to a first body part and wherein said painful therapeutic stimulus is applied to a second, distinct, body part.

57. The apparatus of claim 34 or claim 47 or claim 51, wherein said preceding stimulus and said painful therapeutic stimulus are applied to the same body part.

58. The apparatus of claim 34 or claim 47 or claim 51, wherein said preceding stimulus is applied to at least one first body part selected from the group of the patient'"'"'s body parts consisting of the heart, a blood vessel, an ear, at least one skeletal muscle, a bone, and at least one nerve.

59. The apparatus of claim 34 or claim 47 or claim 51, wherein said painful therapeutic stimulus is applied to at least one second body part selected from the group of the patient'"'"'s body parts consisting of the heart, at least one skeletal muscle, and a blood vessel.

60. The apparatus of claim 59, wherein said at least one second body part includes at least one atrium of the patient'"'"'s heart.

61. The apparatus of claim 59, wherein said at least one second body part includes the patient'"'"'s superior vena cava.

62. The apparatus of claim 59, wherein said at least one second body part includes at least one ventricle of the patient'"'"'s heart.

63. The apparatus of claim 34 or claim 47 or claim 51, wherein said painful therapeutic stimulus comprises an electrical shock for treatment of an atrial or ventricular tachyarrhythmia in the patient.

64. The apparatus of claim 63, wherein said preceding stimulus is synchronized to an electrical signal which is simultaneous with the QRS complex of an electrocardiogram of the patient.

65. The apparatus of claim 34 or claim 47 or claim 51, wherein said preceding stimulus and said painful therapeutic stimulus have the same sensory modality.

66. The apparatus of claim 34 or claim 47 or claim 51, wherein said preceding stimulus and said painful therapeutic stimulus have different sensory modalities.

67. The apparatus of claim 34 or claim 47 or claim 51, wherein said preceding stimulus includes a stimulus which has the same sensory modality as that of said painful therapeutic stimulus and a stimulus which has a different sensory modality than that of said painful therapeutic stimulus.

45. A medical therapeutic apparatus for pretreating a patient prior to a painful therapeutic electrical shock delivered from an implantable cardioverter-defibrillator to treat an arrhythmia, comprising:

(a) at least one first electrode adapted for location in a portion of the patient'"'"'s body selected from the group of portions consisting of the right atrium, superior vena cava, and coronary sinus;

(b) a second electrode adapted for location in the right ventricle of the patient'"'"'s heart;

(c) a pulse generator coupled to said first and second electrodes; and

(d) a controller coupled to said pulse generator and to said first and second electrodes for applying, via said first and second electrodes, preceding patient-perceptible electrical stimulation and a painful therapeutic electrical shock to the patient'"'"'s body after application of said preceding electrical stimulation, wherein said preceding electrical stimulation is initiated within a predetermined time period of 20-500 milliseconds prior to the painful therapeutic shock and has an amplitude of at least 10 volts, whereby the patient perceives pain associated with said painful therapeutic electrical shock as being reduced and/or the patient physiologically responds to said painful therapeutic electrical at a reduced level.

46. An implantable cardioverter-defibrillator apparatus for pretreating a patient prior to a painful therapeutic electrical shock delivered to treat an arrhythmia, which reduces the patient'"'"'s perception of and/or response to the therapeutic electrical shock, comprising:

(a) at least one first electrode adapted for location in a portion of the patient'"'"'s body selected from the group of portions consisting of the right atrium, superior vena cava, and coronary sinus;

(b) at least one second electrode adapted for location in a portion of the patient'"'"'s body selected from the group of portions consisting of the right atrium, superior vena cava, and coronary sinus, but not in said body part in which said at least one first electrode is located;

(c) a third electrode adapted for location in the right ventricle of the patient'"'"'s heart;

(d) a pulse generator coupled to said first, second and third electrodes; and

(e) a controller coupled to said pulse generator and to said first, second and third electrodes for applying, via said first, second and third electrodes, patient-perceptible preceding electrical stimulation of at least 10 volts for a time period between 0.1 and 25 milliseconds to the patient'"'"'s body, wherein said preceding electrical stimulation is initiated within a predetermined time period of 20-500 milliseconds prior to the painful therapeutic shock.

47. A medical therapeutic apparatus, comprising:

(a) at least one transmission element adapted for connection to a patent'"'"'s body;

(b) a pulse generator coupled to said at least one transmission element; and

(c) a controller coupled to said pulse generator and to said at least one transmission element for applying, via said at least one transmission element, a patient-perceptible preceding stimulus to the patient'"'"'s body and for applying, via said at least one transmission element, a painful therapeutic stimulus to the patient'"'"'s after application of said preceding stimulus, wherein said preceding stimulus includes an auditory stimulus initiated within a predetermined time period of 20-500 milliseconds prior to the painful therapeutic stimulus and said at least one transmission element includes a speaker device whereby the patient perceives pain associated with said painful therapeutic stimulus as being reduced and/or the patient physiologically responds to said painful therapeutic stimulus at a reduced level.

48. The apparatus of claim 47, wherein said auditory preceding stimulus is applied to the patient'"'"'s body at an intensity from 0.1 dB(A) to 100 dB(A) above an existing ambient noise level.

49. The apparatus of claim 48, wherein said auditory preceding stimulus is applied to the patient'"'"'s body at an intensity from 5 dB(A) to 15 dB(A) above said existing ambient noise level.

50. The apparatus of claim 47, wherein said preceding stimulus is an auditory prepulse adapted to be audible by said patient prior to applying a relatively large electrical shock as said painful therapeutic stimulus to treat said patient'"'"'s arrhythmia.

51. A medical therapeutic apparatus, comprising:

(a) at least one transmission element adapted for connection to a patent'"'"'s body;

(b) a pulse generator coupled to said at least one transmission element; and

(c) a controller coupled to said pulse generator and to said at least one transmission element for applying, via said at least one transmission element, a patient-perceptible preceding stimulus to the patient'"'"'s body and for applying via said at least one transmission element, a painful therapeutic stimulus to the patient'"'"'s after application of said preceding stimulus, wherein said preceding stimulus includes a vibro-tactile stimulus initiated within a predetermined time period of 20-500 milliseconds prior to the painful therapeutic stimulus and said at least one transmission element includes a vibrator device, whereby the patient perceives pain associated with said painful therapeutic stimulus as being reduced and/or the patient physiologically responds to said painful therapeutic stimulus at a reduced level.

68. The apparatus of claim 51, wherein said preceding stimulus is a vibro-tactile prepulse adapted to be felt by said patient prior to applying a relatively large electrical shock as said painful therapeutic stimulus to treat said patient'"'"'s arrhythmia.

69. A method of cardioverting or defibrillating a patient'"'"'s heart, comprising:

applying a set of cardioversion electrodes to the patient'"'"'s body;

initiating application of a patient-perceptible stimulus to a portion of the patient'"'"'s body other than the patient'"'"'s heart, employing means other than the set of cardio-version electrodes; and

within 20 to 500 milliseconds following initiation of the patient perceptible stimulus, delivering a high voltage shock to the patient'"'"'s heart by means of electrodes within the set of cardioversion electrodes.

70. The method of claim 69 wherein initiating application of a patient-perceptible stimulus comprises initiating application of electrical stimulation.

71. The method of claim 70 wherein initiating application of patient-perceptible stimulation comprises initiating application of stimulation to a body part selected from the group of the patient'"'"'s body parts comprising the patient'"'"'s ear, skeletal muscle, bone, or nerve.

72. The method of claim 70 wherein initiating application of electrical stimulation comprises initiating application of electrical stimulation of at least 10 volts.

73. The method of claim 72 wherein initiating application of electrical stimulation comprises initiating application of electrical stimulation of less than 1000 volts.

74. The method of claim 72 wherein initiating application of electrical stimulation comprises initiating application of electrical stimulation of less than 100 volts.

75. The method of claim 72 wherein initiating application of electrical stimulation comprises initiating application of electrical stimulation for a period of 0.05 to 25 milliseconds.

76. The method of claim 69 wherein initiating application of patient-perceptible stimulation comprises initiating application of auditory stimulation.

77. The method of claim 76, wherein initiating application of auditory stimulation comprises delivering auditory stimulation at an intensity from 0.1 dB(A) to 100 dB(A) above an existing ambient noise level.

78. The method of claim 76, wherein initiating application of auditory stimulation comprises delivering auditory stimulation at an intensity from 5 dB(A) to 15 dB(A) above said existing ambient noise level.

79. The method of claim 69 wherein initiating application of patient-perceptible stimulation comprises initiating application of tactile stimulation.

80. A method of delivering a painful treatment to a portion of a patient'"'"'s body comprising:

applying means for delivery of the painful therapy to a first portion of the patient'"'"'s body;

initiating application of a patient perceptible stimulus to a second portion of the patient'"'"'s body other than the first portion, employing means other than the means for delivery of the painful therapy; and

within 20 to 500 milliseconds following initiation of the patient-perceptible stimulus, delivering the painful therapy.

81. The method of claim 80 wherein initiating application of a patient-perceptible stimulus comprises initiating application of electrical stimulation.

82. The method of claim 81 wherein initiating application of electrical stimulation comprises initiating application of electrical stimulation of at least 10 volts.

83. The method of claim 82 wherein initiating application of electrical stimulation comprises initiating application of electrical stimulation of less than 1000 volts.

84. The method of claim 82 wherein initiating application of electrical stimulation comprises initiating application of electrical stimulation of less than 100 volts.

85. The method of claim 82 wherein initiating application of electrical stimulation comprises initiating application of electrical stimulation for a period of 0.05 to 25 milliseconds.

86. The method of claim 80 wherein initiating application of patient-perceptible stimulation comprises initiating application of auditory stimulation.

87. The method of claim 86, wherein initiating application of auditory stimulation comprises delivering auditory stimulation at an intensity from 0.1 dB(A) to 100 dB(A) above an existing ambient noise level.

88. The method of claim 86, wherein initiating application of auditory stimulation comprises delivering auditory stimulation at an intensity from 5 dB(A) to 15 dB(A) above said existing ambient noise level.

89. The method of claim 80 wherein initiating application of patient-perceptible stimulation comprises initiating application of tactile stimulation.

90. The method of claim 80 wherein initiating application of patient-perceptible stimulation comprises initiating application of stimulation to a body part selected from the group of the patient'"'"'s body parts comprising the patient'"'"'s ear, skeletal muscle, bone, or nerve.

91. The method of claim 80 or claim 90 wherein delivering the painful therapy comprises delivering a cardioversion or defibrillation pulse.