Heart failure therapy device and method

• US 20030229380A1
• Filed: 10/31/2002
• Published: 12/11/2003
• Est. Priority Date: 10/31/2002
• Status: Abandoned Application

• Current Assignee: Scout Medical Technologies LLC (Mpm Capital LLC)
• Original Assignee: Scout Medical Technologies LLC (Mpm Capital LLC)
• Inventors: Alferness, Clifton A., Adams, John M.
• Application Number:
  US10/287,254
• Publication Number:
  US 20030229380A1
• Time in Patent Office: Days
• US Class Current: 607/9
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

The heart rate of a patient with conditions such as chronic heart failure, ischemia, or acute myocardial infarction is reduced by electrically stimulating the right vagus nerve of the patient. A lead is implanted with electrodes in electrical communication with tissue proximate to the vagus nerve. A stimulator in electrical communication with the electrodes delivers electrical energy that stimulates the release of acetylcholine from the vagus nerve. The amount of energy may be determined in accordance with a difference between the patient'"'"'s actual heart rate and a maximum target heart rate for the patient. Delivery of energy to the lead electrodes is preferably synchronized with the detection of a P-wave. Automatic adjustment of the target heart rate may be based on current day and/or time of day information, and patient physical activity. The voltage, pulse width, or number of pulses in the stimulation may be controlled.

Claims

1. A device for reducing the normal sinus heart rate of a patient, comprising:

(a) a lead with electrodes configured for implantation in the patient such that the electrodes are in electrical communication with tissue proximate to a right vagus nerve of the patient;

(b) detection circuitry with electrodes configured to detect a complex in the patient'"'"'s normal sinus rhythm;

(c) stimulation circuitry in electrical communication with the lead for delivering electrical energy to the lead electrodes to stimulate the right vagus nerve of the patient; and

(d) control circuitry in communication with the stimulation circuitry for controlling the delivery of the electrical energy to the lead electrodes.

2. The device of claim 1, in which the lead electrodes are also the electrodes for the detection circuitry.

3. The device of claim 1, in which the lead electrodes are configured to be placed in or near an atrium of the patient'"'"'s heart.

4. The device of claim 3, in which the atrium is the right atrium, and in which the lead electrodes deliver electrical energy that stimulates the patient'"'"'s right vagus nerve.

5. The device of claim 4, in which the lead electrodes are configured to be placed proximate to the junction of the superior vena cava and the right atrium near the sinoatrial node of the patient.

6. The device of claim 3, in which the detection circuitry is configured to detect a P-wave in the patient'"'"'s normal sinus rhythm.

7. The device of claim 6, in which the delivery of electrical energy is synchronized with the detection of a P-wave.

8. The device of claim 7, in which the delivery of electrical energy is synchronized to occur during a refractory period following the detection of a P-wave.

9. The device of claim 1, in which the lead is a first lead, the device further comprising a second lead with electrodes implanted in a ventricle of the patient'"'"'s heart.

10. The device of claim 9, in which the electrodes of the second lead are also the electrodes for the detection circuitry.

11. The device of claim 9, in which the detection circuitry is configured to detect an R-wave in the patient'"'"'s normal sinus rhythm.

12. The device of claim 1, further comprising an activity sensor in communication with the control circuitry, the activity sensor being configured to sense physical activity of the patient.

13. The device of claim 12, in which the amount of electrical energy delivered to the lead electrodes is adjusted when the activity sensor senses increased physical activity in the patient.

14. The device of claim 1, in which an actual heart rate of the patient is determined from the detection of complexes in the patient'"'"'s normal sinus rhythm.

15. The device of claim 14, in which the electrical energy is delivered in one or more pulses, and in which the control circuitry is configured to control the voltage of the one or more pulses in accordance with the patient'"'"'s actual heart rate.

16. The device of claim 14, in which the electrical energy is delivered in one or more pulses, and in which the control circuitry is configured to control the duration of the one or more pulses in accordance with the patient'"'"'s actual heart rate.

17. The device of claim 14, in which the electrical energy is delivered in one or more pulses, and in which the control circuitry is configured to control the number of pulses in accordance with the patient'"'"'s actual heart rate.

18. The device of claim 14, in which the control circuitry is configured to control the ratio of stimulus to heart beats in accordance with the patient'"'"'s actual heart rate.

19. The device of claim 1, in which the control circuitry is configured to control the delivery of electrical energy to the lead electrodes in accordance with a difference between an actual heart rate of the patient and a target heart rate for the patient.

20. The device of claim 19, in which the control circuitry is further configured to measure day information and to automatically adjust the target heart rate for the patient based on current day information.

21. The device of claim 20, in which the current day information reflects the number of days since the control circuitry began to measure day information.

22. The device of claim 21, in which the current day information is measured from when the lead was implanted in the patient.

23. The device of claim 20, in which the current day information reflects an amount of time since the control circuitry began to measure day information.

24. The device of claim 19, in which the control circuitry is further configured to measure time of day information and to automatically adjust the target heart rate for the patient based on current time of day information.

25. The device of claim 24, in which the control circuitry is configured to automatically adjust the target heart rate downward when the current time of day information reflects a time in which the patient is normally sleeping.

26. The device of claim 19, further comprising an activity sensor in communication with the control circuitry, the activity sensor being configured to sense physical activity of the patient.

27. The device of claim 26, in which the control circuitry is configured to automatically adjust the target heart rate for the patient based on the physical activity sensed in the patient.

28. The device of claim 19, in which the electrical energy is delivered in one or more pulses, and in which the control circuitry is configured to control the voltage of the one or more pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

29. The device of claim 19, in which the electrical energy is delivered in one or more pulses, and in which the control circuitry is configured to control the duration of the one or more pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

30. The device of claim 19, in which the electrical energy is delivered in one or more pulses, and in which the control circuitry is configured to control the number of pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

31. The device of claim 19, in which the control circuitry is configured to control the ratio of stimulus to heart beats in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

32. The device of claim 1, in which the electrical energy is delivered to the lead electrodes over a period of days to gradually reduce the normal sinus heart rate of the patient.

33. The device of claim 1, in which the electrical energy delivered to the lead electrodes is increased over a period of days to gradually reduce the normal sinus heart rate of the patient.

114. The method of claim 1, further comprising delivering the electrical stimulation to the lead electrodes in an amount that is increased over a period of days to gradually reduce the normal sinus heart rate of the patient.

34. A device for treating heart failure or ischemia in a patient, comprising:

(a) a power source for providing electrical energy;

(b) a stimulator connected to the power source for delivering electrical energy in one or more pulses shaped for stimulation of the right vagus nerve of the patient; and

(c) a processor in communication with the stimulator, the processor being configured to control the delivery of the one or more pulses from the stimulator, wherein the stimulation of the right vagus nerve by the one or more pulses produces a reduction of the normal sinus heart rate of the patient.

35. The device of claim 34, in which the processor is comprised of basic logic circuitry that causes the stimulator to deliver the one or more pulses of electrical energy.

36. The device of claim 34, further comprising detection circuitry configured to receive an electrogram signal from the patient and produce a control signal identifying the detection of a complex in the electrogram signal.

37. The device of claim 36, in which the detection circuitry is a P-wave detector that produces a control signal identifying the detection of a P-wave in the electrogram signal.

38. The device of claim 37, in which the control signal is delivered to the processor which causes the stimulator to deliver the one or more pulses synchronized with the detection of a P-wave.

39. The device of claim 38, in which the delivery of the one or more pulses is synchronized to occur during a refractory period following the detection of a P-wave.

40. The device of claim 37, further comprising a counter for counting the number of P-waves with which stimulation of the right vagus nerve occurred.

41. The device of claim 37, further comprising a counter for counting the number of P-waves with which no stimulation of the right vagus nerve occurred.

42. The device of claim 36, in which the detection circuitry is an R-wave detector that produces a control signal identifying the detection of an R-wave in the electrogram signal.

43. The device of claim 36, in which an actual heart rate of the patient is determined from the detection of complexes in the electrogram signal.

44. The device of claim 43, in which the processor is configured to control the voltage of the one or more pulses in accordance with the patient'"'"'s actual heart rate.

45. The device of claim 43, in which the processor is configured to control the duration of the one or more pulses in accordance with the patient'"'"'s actual heart rate.

46. The device of claim 43, in which the processor is configured to control the number of pulses in accordance with the patient'"'"'s actual heart rate.

47. The device of claim 43, in which the processor is configured to control the ratio of stimulus to heart beats in accordance with the patient'"'"'s actual heart rate.

48. The device of claim 43, in which the processor is configured to control the delivery of the one or more pulses in accordance with a difference between the actual heart rate and a target heart rate for the patient.

49. The device of claim 48, in which the processor is further configured to automatically adjust the target heart rate for the patient based on a programmed heart rate reduction curve.

50. The device of claim 48, in which the processor is further configured to automatically adjust the target heart rate for the patient based on time of day.

51. The device of claim 48, further comprising an activity sensor in communication with the processor, the activity sensor being configured to sense physical activity of the patient.

52. The device of claim 51, in which the processor is configured to automatically adjust the target heart rate for the patient based on physical activity sensed in the patient.

53. The device of claim 48, in which the processor is configured to control the voltage of the one or more pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

54. The device of claim 48, in which the processor is configured to control the duration of the one or more pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

55. The device of claim 48, in which the processor is configured to control the number of pulses in the one or more pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

56. The device of claim 48, in which the processor is configured to control the ratio of stimulus to heart beats in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

57. The device of claim 34, in which stimulation is delivered to the patient over a period of days to gradually reduce the normal sinus heart rate of the patient.

58. The device of claim 34, in which the stimulation delivered to the lead electrodes is increased over a period of days to gradually reduce the normal sinus heart rate of the patient.

59. A vagal nerve stimulator, comprising:

(a) electrodes configured for implanting in a patient such that the electrodes are proximate to tissue next to or surrounding the patient'"'"'s right vagus nerve in the area of the sinoatrial node of the patient'"'"'s heart;

(b) a detector for receiving a physiological signal from the patient and producing a detection signal signifying detection of a contraction in the patient'"'"'s heart;

(c) a stimulator configured to receive the detection signal and deliver electrical energy to the electrodes during a refractory period following the contraction of the patient'"'"'s heart.

60. The vagal nerve stimulator of claim 59, in which the detector is configured to detect a P-wave and produce a detection signal signifying detection of a contraction of an atrium in the patient'"'"'s heart.

61. The vagal nerve stimulator of claim 60, in which delivery of electrical energy is synchronized with the detection of a P-wave.

62. The vagal nerve stimulator of claim 59, in which the detector is configured to detect an R-wave and produce a detection signal signifying detection of a contraction of an ventricle in the patient'"'"'s heart.

63. The vagal nerve stimulator of claim 59, in which the stimulator is configured to determine the patient'"'"'s heart rate from the detection signal and control the voltage of the electrical energy delivered to the electrodes in accordance with the patient'"'"'s heart rate.

64. The vagal nerve stimulator of claim 59, in which the stimulator is configured to determine the patient'"'"'s heart rate from the detection signal and control the duration of the electrical energy delivered to the electrodes in accordance with the patient'"'"'s heart rate.

65. The vagal nerve stimulator of claim 59, in which the stimulator is configured to determine the patient'"'"'s heart rate from the detection signal and control the ratio of stimulus to heart beats in accordance with the patient'"'"'s heart rate.

66. A method for reducing the normal sinus heart rate of a patient, comprising:

(a) implanting a lead with electrodes in the patient such that the electrodes are in electrical communication with tissue proximate to a right vagus nerve of the patient;

(b) detecting a complex in the patient'"'"'s normal sinus rhythm;

(c) stimulating the right vagus nerve of the patient by delivering electrical energy to the lead electrodes synchronized with the detection of a complex in the patient'"'"'s normal sinus rhythm.

67. The method of claim 66, further comprising placing the lead electrodes in or near an atrium of the patient'"'"'s heart.

68. The method of claim 67, in which the atrium is the right atrium, and in which the electrical energy stimulates the patient'"'"'s right vagus nerve in the vicinity of the sinoatrial node and superior vena cava of the patient.

69. The method of claim 66, in which the complex is a P-wave in the patient'"'"'s normal sinus rhythm and the delivery of electrical energy is synchronized with the detection of a P-wave.

70. The method of claim 69, in which the delivery of electrical energy is synchronized to occur during a refractory period following the detection of a P-wave.

71. The method of claim 66, in which the lead is a first lead, the method further comprising implanting a second lead with electrodes in a ventricle of the patient'"'"'s heart.

72. The method of claim 71, further comprising detecting an R-wave in the patient'"'"'s normal sinus rhythm.

73. The method of claim 66, further comprising sensing physical activity of the patient and increasing the amount of electrical energy delivered to the lead electrodes when increased physical activity is sensed in the patient.

74. The method of claim 66, further comprising detecting an actual heart rate of the patient from the detection of complexes in the patient'"'"'s normal sinus rhythm.

75. The method of claim 73, in which the electrical energy is delivered in one or more pulses, the method further comprising controlling the voltage of the one or more pulses in accordance with the patient'"'"'s actual heart rate.

76. The method of claim 73, in which the electrical energy is delivered in one or more pulses, the method further comprising controlling the duration of the one or more pulses in accordance with the patient'"'"'s actual heart rate.

77. The method of claim 73, in which the electrical energy is delivered in one or more pulses, the method further comprising controlling the number of pulses in accordance with the patient'"'"'s actual heart rate.

78. The method of claim 73, further comprising controlling the ratio of stimulus to heart beats in accordance with the patent'"'"'s actual heart rate.

79. The method of claim 66, further comprising controlling the delivery of electrical energy to the lead electrodes in accordance with a difference between an actual heart rate of the patient and a target heart rate for the patient.

80. The method of claim 79, further comprising measuring day information and automatically adjusting the target heart rate for the patient based on current day information.

81. The method of claim 80, in which the current day information reflects the number of days since beginning to measure day information.

82. The method of claim 81, in which the current day information is measured from when the lead was implanted in the patient.

83. The method of claim 80, in which the current day information reflects an amount of time since beginning to measure day information.

84. The method of claim 79, further comprising measuring time of day information and automatically adjusting the target heart rate for the patient based on current time of day information.

85. The method of claim 84, in which the target heart rate is automatically adjusted downward when the current time of day information reflects a time in which the patient is normally sleeping.

86. The method of claim 79, further comprising sensing physical activity of the patient and automatically adjusting the target heart rate for the patient based on physical activity sensed in the patient.

87. The method of claim 79, in which the electrical energy is delivered in one or more pulses, the method further comprising controlling the voltage of the one or more pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

88. The method of claim 79, in which the electrical energy is delivered in one or more pulses, the method further comprising controlling the duration of the one or more pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

89. The method of claim 79, in which the electrical energy is delivered in one or more pulses, the method further comprising controlling the number of pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

90. The method of claim 79, further comprising controlling the ratio of stimulus to heart beats in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

91. The method of claim 66, further comprising delivering the electrical energy to the lead electrodes over a period of days to gradually reduce the normal sinus heart rate of the patient.

92. The method of claim 66, further comprising delivering the electrical energy the lead electrodes in an amount that is increased over a period of days to gradually reduce the normal sinus heart rate of the patient.

93. A method for treating heart failure or ischemia, comprising:

(a) providing a power source;

(b) delivering electrical energy from the power source in one or more pulses shaped for stimulation of the right vagus nerve of a patient; and

(c) controlling the delivery of the one or more pulses such that the stimulation of the right vagus nerve by the one or more pulses produces a reduction of the normal sinus heart rate of the patient.

94. The method of claim 93, further comprising receiving an electrogram signal from the patient and producing a control signal identifying the detection of a complex in the electrogram signal.

95. The method of claim 94, in which the complex is a P-wave, the method further comprising delivering the one or more pulses synchronized with the detection of a P-wave.

96. The method of claim 95, in which the delivery of the one or more pulses is synchronized to occur during a refractory period following the detection of a P-wave.

97. The method of claim 94, further comprising counting the number of complexes with which stimulation of the right vagus nerve occurred.

98. The method of claim 94, further comprising counting the number of complexes with which no stimulation of the right vagus nerve occurred.

99. The method of claim 94, in which the complex is an R-wave in the electrogram signal.

100. The method of claim 94, further comprising determining an actual heart rate of the patient from the detection of complexes in the electrogram signal.

101. The method of claim 100, further comprising controlling the voltage of the one or more pulses in accordance with the patient'"'"'s actual heart rate.

102. The method of claim 100, further comprising controlling the duration of the one or more pulses in accordance with the patient'"'"'s actual heart rate.

103. The method of claim 100, further comprising controlling the number of pulses in accordance with the patient'"'"'s actual heart rate.

104. The method of claim 100, further comprising controlling the ratio of stimulus to heart beats in accordance with the patient'"'"'s actual heart rate.

105. The method of claim 100, in which the delivery of the one or more pulses is controlled in accordance with a difference between the actual heart rate and a target heart rate for the patient.

106. The method of claim 105, further comprising automatically adjusting the target heart rate for the patient based on a preprogrammed heart rate reduction curve.

107. The method of claim 105, further comprising automatically adjusting the target heart rate for the patient based on time of day.

108. The method of claim 105, further comprising sensing physical activity of the patient and automatically adjusting the target heart rate for the patient based on physical activity sensed in the patient.

109. The method of claim 105, further comprising controlling the voltage of the one or more pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

110. The method of claim 105, further comprising controlling the duration of the one or more pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

111. The method of claim 105, further comprising controlling the number of pulses in the one or more pulses in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

112. The method of claim 105, further comprising controlling the ratio of stimulus to heart beats in accordance with the difference between the patient'"'"'s actual heart rate and the target heart rate.

113. The method of claim 93, further comprising delivering the electrical stimulation to the patient over a period of days to gradually reduce the normal sinus heart rate of the patient.

115. A device for treating cardiovascular disease in a patient, comprising:

(a) a lead with electrodes configured for implantation in the patient near the sinoatrial node of the patient'"'"'s heart; and

(b) a pulse generator in electrical communication with the lead electrodes for delivering one or more electrical pulses to the electrodes that stimulate cholinergic fibers to release acetylcholine which is taken up by the patient'"'"'s sinoatrial node.

116. The device of claim 115, in which the lead electrodes are configured for placement at the junction of the superior vena cava and the right atrium of the patient'"'"'s heart.

117. The device of claim 115, in which the acetylcholine that is taken up by the sinoatrial node causes a time delay to the next heart beat in the patient.

118. The device of claim 117, in which the pulse generator controls the time delay to the next heart beat by controlling the electrical pulses delivered to the patient.

119. The device of claim 117, in which increasing the time delay to the next heart beat causes a reduction of blood pressure in the patient.

120. The device of claim 119, in which the reduction of blood pressure is determined from a difference between the patient'"'"'s current blood pressure and a target blood pressure.

121. The device of claim 115, further comprising detection circuitry configured to detect a heart beat in the patient and cause the pulse generator to deliver an electrical pulse during a refractory period in the heart beat.

122. A method of treating cardiovascular disease in a patient, comprising:

(a) implanting a lead with electrodes in the patient near the sinoatrial node of the patient'"'"'s heart; and

(b) delivering to the lead electrodes one or more electrical pulses that stimulate cholinergic fibers to release acetylcholine which is taken up by the patient'"'"'s sinoatrial node.

123. The method of claim 122, in which the lead electrodes are implanted at the junction of the superior vena cava and the right atrium of the patient'"'"'s heart.

124. The method of claim 122, in which the acetylcholine that is taken up by the sinoatrial node causes a time delay to the next heart beat in the patient, the method further comprising controlling the time delay to the next heart beat by controlling the electrical pulses delivered to the patient.

125. The method of claim 124, further comprising causing in a reduction of blood pressure in the patient by increasing the time delay to the next heart beat.

126. The method of claim 125, further comprising determining the reduction of blood pressure from a difference between the patient'"'"'s current blood pressure and a target blood pressure.

127. The device of claim 122, further comprising detecting a heart beat in the patient and delivering an electrical pulse to the lead electrodes during a refractory period in the heart beat.

128. An electrical lead configured for implantation in a patient'"'"'s heart, comprising:

(a) a length of electrically conductive material in an insulating substrate; and

(b) a plurality of electrodes attached to the insulating substrate and electrically connected to the conductive material, in which a first electrode is disposed along the length of the insulating substrate and a second electrode is disposed near a distal end of the lead, the first and second electrodes having sufficient distance between them to allow the first electrode to be located in the superior vena cava while the second electrode is located in the atrium near the sinoatrial node when implanted in the heart of the patient.

129. The electrical lead of claim 128, further comprising a hook-shaped bend in the insulating substrate between the first and second electrodes.

130. The electrical lead of claim 128, further comprising one or more helical windings of the insulating substrate that places the first electrode in the superior vena cava and the second electrode near the sinoatrial node when the lead is implanted in the heart of the patient.

131. The electrical lead of claim 128, in which the lead includes three or more electrodes attached to the insulating substrate and electrically connected to the conductive material, wherein when implanted, all of the electrodes are disposed proximal to tissue containing right vagus nerves that innervate the sinoatrial node of the patient.