Method and device for electronically controlling the beating of a heart

• US 6,542,774 B2
• Filed: 07/02/2001
• Issued: 04/01/2003
• Est. Priority Date: 04/30/1996
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Jonkman, Kenneth R., Hill, Michael R. S.
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/897,630
• Publication Number:
  US 20020026221A1
• Time in Patent Office: 638 Days
• Field of Search: 607/2, 607/9, 607/39-41, 607/10, 607/118, 607/119, 607/142
• US Class Current: 607/9
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00969 used for transplantation
• CPC Class Codes: A61B 2017/0243 for immobilizing local areas of the heart, e.g. while it beats trocars attached to inner organs or inner body tissue A61B2017/3488
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2017/3449 whereby the instrument channels merge into one single channel
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/385 Devices for inducing an abnormal cardiac function, e.g. fibrillation
• CPC Class Codes: A61N 1/3962 in combination with another heart therapy
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

An electro-stimulation device includes a pair of electrodes for connection to at least one location in the body that affects or regulates the heartbeat. The electro-stimulation device both electrically arrests the heartbeat and stimulates the heartbeat. A pair of electrodes are provided for connection to at least one location in the body that affects or regulates the heartbeat. The pair of electrodes may be connected to an intravenous catheter for transvenous stimulation of the appropriate nerve. A first switch is connected between a power supply and the electrodes for selectively supplying current from the power supply to the electrodes to augment any natural stimuli to the heart and thereby stop the heart from beating. A second switch is connected between the power supply and the electrodes for selectively supplying current from the power supply to the electrodes to provide an artificial stimulus to initiate heartbeating. In another aspect, the invention is directed to a method for arresting the beat of a heart in a living body comprising the steps of connecting the pair of electrodes to at least one location in the body that affects or regulates the heartbeat and supplying an electrical current to the electrodes of sufficient amplitude and duration to arrest the heartbeat. The device may also serve to still the lungs by input to a respirator or by stimulation of the phrenic nerve during surgical procedures.

Claims

1. A method for selectively destimulating and stimulating a heart within a patient during a medical procedure comprising:

a. connecting a first set of at least two electrodes to at least one first location within the patient that regulates the heart;

b. connecting a second set of at least two electrodes to at least one second location within the patient that regulates the heart;

c. selectively supplying electrical energy from a power supply to the first set of electrodes during the medical procedure, the supply of the electrical energy to the first set of electrodes being of sufficient amplitude and duration to destimulate the heart; and

,

d. selectively supplying electrical energy from the power supply to the second set of electrodes during the medical procedure, the supply of the electrical energy to the second set of electrodes being of sufficient amplitude and duration to stimulate the heart.

2. The method of claim 1 wherein at least one switch is connected between the power supply and at least one set of electrodes, the switch controlling the supply of the electrical energy from the power supply to the electrodes, the supply of the electrical energy to the electrodes being of sufficient amplitude and duration to stimulate or destimulate the heart.

3. The method of claim 2 wherein the at least one switch is operated manually.

4. The method of claim 2 wherein the at least one switch is operated automatically.

5. The method of claim 2 wherein the at least one switch is a hand switch.

6. The method of claim 2 wherein the at least one switch is a foot switch.

7. The method of claim 2 wherein the at least one switch is controlled by a timer which actuates the at least one switch when the selected amount of time has been reached.

8. The method of claim 7 wherein the timer sets off an audible signal to indicate when the selected amount of time has been reached is included.

9. The method of claim 1 wherein the at least one switch intermittently changes between stimulation and destimulation each time the switch is actuated.

10. The method of claim 2 wherein a foot pedal is included to selectively actuate the at least one switch.

11. The method of claim 1 wherein a first switch is connected between the power supply and the first set of electrodes and a second switch is connected between the power supply and the second set of electrodes, the first switch controlling the supply of the electrical energy from the power supply to the first set of electrodes, the supply of the electrical energy to the first set of electrodes being of sufficient amplitude and duration to destimulate the heart, the second switch being connected between the power supply and the second set of electrodes, the second switch controlling the supply of the electrical energy from the power supply to the second set of electrodes, the supply of the electrical energy to the second set of electrodes being of sufficient amplitude and duration to stimulate the heart.

12. The method of claim 1 wherein at least one electrode of the first set of electrodes is placed adjacent a nerve that regulates the heart.

13. The method of claim 12 wherein the nerve is a parasympathetic nerve.

14. The method of claim 13 wherein the parasympathetic nerve is a vagal nerve.

15. The method of claim 12 wherein the at least one electrode of the first set of electrodes is placed within an organ adjacent the nerve.

16. The method of claim 15 wherein the organ is a blood vessel.

17. The method of claim 16 wherein the blood vessel is an artery.

18. The method of claim 17 wherein the blood vessel is a carotid artery.

19. The method of claim 16 wherein the blood vessel is a vein.

20. The method of claim 19 wherein the blood vessel is a jugular vein.

21. The method of claim 19 wherein the blood vessel is a superior vena cava.

22. The method of claim 19 wherein the blood vessel is an azygous vein.

23. The method of claim 19 wherein the blood vessel is a hemizygous vein.

24. The method of claim 1 wherein the nerve is located in an epicardial fat pad.

25. The method of claim 24 wherein the epicardial fat pad is located at the right atrium.

26. The method of claim 24 wherein the epicardial fat pad is located at the superior vena cava.

27. The method of claim 24 wherein the epicardial fat pad is located at the right pulmonary vein.

28. The method of claim 1 wherein at least one location is at least one point located on a nerve fiber.

29. The method of claim 1 wherein at least one location is at least one point located on an organ wall.

30. The method of claim 1 wherein at least one location is at least one point located adjacent a nerve fiber.

31. The method of claim 1 wherein the electrical energy is an alternating current.

32. The method of claim 1 wherein the electrical energy is a waveform current.

33. The method of claim 1 wherein the electrical energy is a direct current.

34. The method of claim 33 wherein the direct current is a pulsed current.

35. The method of claim 1 wherein the electrical energy is a continuous pulse train of about 10 to 30 seconds.

36. The method of claim 1 wherein the electrical energy is a constant current of about 10 to 100 milliamps.

37. The method of claim 1 wherein the electrical energy is a constant pulse width.

38. The method of claim 1 wherein the electrical energy comprises a frequency between about 6 and 50 hertz.

39. The method of claim 1 wherein the electrical energy comprises a burst pulse width of current.

40. The method of claim 39 wherein the burst pulse width of current is programmably controlled.

41. The method of claim 1 wherein the power supply is a regulated power source.

42. The method of claim 1 wherein the power supply comprises a battery and a regulator.

43. The method of claim 1 wherein at least one set of electrodes are located bilaterally.

44. The method of claim 1 wherein at least one set of electrodes are nerve cuff electrodes.

45. The method of claim 1 wherein at least one set of electrodes are impalement electrodes.

46. The method of claim 1 wherein at least one set of electrodes are attached to a transvenous lead.

47. The method of claim 1 wherein at least one set of electrodes are attached to an electrode pad.

48. The method of claim 1 wherein at least one set of electrodes are attached to a catheter.

49. The method of claim 48 wherein the electrodes are positioned circumferentially around the catheter.

50. The method of claim 48 wherein the electrodes are positioned axially along the catheter.

51. The method of claim 48 wherein the electrodes are positioned both axially along the catheter and circumferentially around the catheter.

52. The method of claim 1 wherein at least one electrode is used for sensing.

53. The method of claim 1 wherein at least one electrode is connected to a sinoatrial region of a heart.

54. The method of claim 1 wherein at least one electrode is connected to an atrioventricular region of the heart.

55. The method of claim 1 wherein at least one set of electrodes are connected in a unipolar arrangement.

56. The method of claim 1 wherein at least one set of electrodes are connected in a bipolar arrangement.

57. The method of claim 1 wherein at least one electrode comprises a corkscrew.

58. The method of claim 1 wherein at least one electrode comprises a clip.

59. The method of claim 1 wherein at least one electrode comprises a pad.

60. The method of claim 1 wherein at least one electrode comprises a tine.

61. The method of claim 1 wherein at least one electrode comprises a barb.

62. The method of claim 1 wherein at least one electrode comprises a needle.

63. The method of claim 1 wherein at least one set of electrodes are controlled by a sensor.

64. The method of claim 1 wherein at least one electrode comprises a lead.

65. The method of claim 1 wherein at least one set of electrodes comprise an electrode array.

66. The method of claim 1 wherein the medical procedure is a diagnostic procedure.

67. The method of claim 1 wherein the medical procedure is a therapeutic procedure.

68. The method of claim 1 wherein the medical procedure is a minimally-invasive surgical procedure.

69. The method of claim 1 wherein the medical procedure is an open-heart surgical procedure.

70. The method of claim 1 wherein the medical procedure is a coronary artery bypass graft procedure.

71. The method of claim 1 wherein the medical procedure is an endoscopic surgical procedure.

72. The method of claim 1 wherein the medical procedure is a minithorascopic surgical procedure.

73. The method of claim 1 wherein a drug is supplied to the heart from a drug dispenser.

74. The method of claim 1 wherein a sensor that regulates the supply of electrical energy to at least one set of electrodes is included.

75. The method of claim 74 wherein the sensor is an electrical sensor.

76. The method of claim 74 wherein the sensor is a pressure sensor.

77. The method of claim 75 wherein the sensor is a temperature sensor.

78. The method of claim 1 further comprising connecting a third set of at least two electrodes to at least one third location within the patient that regulates breathing, selectively supplying electrical energy from the power supply to the third set of electrodes during the medical procedure, the supply of the electrical energy to the third set of electrodes being of sufficient amplitude and duration to control the patient'"'"'s breathing.

79. The method of claim 78 wherein at least one electrode of the third set of electrodes is placed adjacent a nerve that regulates the heart.

80. The method of claim 79 wherein the nerve is a phrenic nerve.

81. The method of claim 79 wherein the at least one electrode of the third set of electrodes is placed within an organ adjacent the nerve.

82. The method of claim 1 further comprising connecting an electrical lead connected to the power supply having a connector that interfaces with a respirator and upon stimulation or destimulation of the heart supplies a signal to the respirator to activate or deactivate the respirator.

83. A method for selectively destimulating and stimulating a heart within a patient during a medical procedure comprising:

a. placing at least one electrode of a first set of at least two electrodes adjacent a nerve within the patient that regulates the heart;

b. placing at least one electrode of a second set of at least two electrodes adjacent the surface of the heart within the patient;

c. selectively supplying electrical energy from a power supply to the first set of electrodes during the medical procedure, the supply of the electrical energy to the first set of electrodes being of sufficient amplitude and duration to stimulate the nerve; and

,

d. selectively supplying electrical energy from the power supply to the second set of electrodes during the medical procedure, the supply of the electrical energy to the second set of electrodes being of sufficient amplitude and duration to stimulate the heart.

84. The method of claim 83 wherein the nerve is a parasympathetic nerve.

85. The method of claim 84 wherein the parasympathetic nerve is a vagal nerve.

86. The method of claim 83 wherein the at least one electrode of the first set of electrodes is placed within an organ adjacent the nerve.

87. The method of claim 86 wherein the nerve is a parasympathetic nerve.

88. The method of claim 87 wherein the parasympathetic nerve is a vagal nerve.

89. The method of claim 86 wherein the organ is a blood vessel.

90. The method of claim 89 wherein the blood vessel is an artery.

91. The method of claim 89 wherein the blood vessel is a vein.

92. The method of claim 83 wherein stimulation of the nerve causes the heart to beat slower.

93. The method of claim 83 wherein stimulation of the nerve causes the heart to stop beating.

94. A method for selectively destimulating and stimulating a heart within a patient during a medical procedure comprising:

a. placing at least one electrode of a first set of at least two electrodes adjacent a nerve within the patient that regulates the heart;

b. placing at least one electrode of a second set of at least two electrodes on the surface of the heart within the patient;

c. selectively supplying electrical energy from a power supply to the first set of electrodes during the medical procedure, the supply of the electrical energy to the first set of electrodes being of sufficient amplitude and duration to stimulate the nerve;

d. selectively supplying electrical energy from the power supply to the second set of electrodes during the medical procedure, the supply of the electrical energy to the second set of electrodes being of sufficient amplitude and duration to stimulate the heart; and

,

e. sending a signal upon stimulation of the nerve or heart to activate or deactivate a respirator.

95. The method of claim 94 wherein the nerve is a parasympathetic nerve.

96. The method of claim 95 wherein the parasympathetic nerve is a vagal nerve.

97. The method of claim 94 wherein the at least one electrode of the first set of electrodes is placed within an organ adjacent the nerve.

98. The method of claim 97 wherein the nerve is a parasympathetic nerve.

99. The method of claim 98 wherein the parasympathetic nerve is a vagal nerve.

100. The method of claim 97 wherein the organ is a blood vessel.

101. The method of claim 100 wherein the blood vessel is an artery.

102. The method of claim 100 wherein the blood vessel is a vein.

103. The method of claim 94 wherein stimulation of the nerve causes the heart to beat slower.

104. The method of claim 94 wherein stimulation of the nerve causes the heart to stop beating.