BAROREFLEX ACTIVATION THERAPY WITH CONDITIONAL SHUT OFF

• US 20090132002A1
• Filed: 05/07/2008
• Published: 05/21/2009
• Est. Priority Date: 05/11/2007
• Status: Abandoned Application

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Kieval, Robert S.
• Application Number:
  US12/116,435
• Publication Number:
  US 20090132002A1
• Time in Patent Office: Days
• US Class Current: 607/44
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate

Abstract

An exemplary embodiment of the present invention provides systems, devices, and methods for using the same for activating (stimulating) the baroreflex system of a patient using a baroreflex activation system which may be automatically shut off or discontinue therapy by sensing/monitoring/interpreting sensed data which is indicative of a physiological condition of a patient.

Claims

1. A method for treating a patient, comprising:

activating a baroreflex system of the patient with a baroreflex activation device according to a baroreflex activation therapy;

establishing a threshold range for a parameter indicative of a physiological condition;

monitoring the parameter; and

adjusting the baroreflex therapy in response to a value of the monitored parameter if the parameter value is outside of the threshold range.

2. The method of claim 1, wherein the threshold range is stored in a memory of the baroreflex activation device.

3. The method of claim 1, further comprising comparing a value of the monitored parameter to the threshold range of the parameter.

4. The method of claim 3, wherein the adjusting comprises discontinuing the baroreflex activation therapy if the monitored parameter is outside of the threshold range.

5. The method of claim 3, wherein the adjusting comprises discontinuing the baroreflex therapy if the value of the monitored parameter is below the parameter threshold range.

6. The method of claim 3, further comprising continuing the baroreflex therapy if the value of the monitored parameter is at or above the threshold range.

7. The method of claim 3, wherein the monitoring of the monitored parameter continues and the parameter value is compared to the threshold range to determine whether baroreflex activation therapy should continue.

8. The method of claim 5, wherein the monitoring of the monitored parameter continues and the parameter value is compared to the threshold range to determine whether baroreflex activation therapy should resume.

9. The method of claim 8, wherein the therapy is resumed once the value of the parameter is at or above the threshold range.

10. The method of claim 1, wherein the baroreflex activation therapy continues as long as the value of the monitored parameter is greater than or equal to the threshold range.

11. The method of claim 1, wherein the activation of the baroreflex system comprises activating at least one of a baroreceptor, one or more nerves emanating from a baroreceptor, and a carotid nerve.

12. The method of claim 1, wherein the activation of the baroreflex system comprises activating at least one of a baroreceptor, a mechanoreceptor, a pressoreceptor, or another receptor which affects blood pressure, nervous system activity, or neurohormonal activity in a manner analogous to baroreceptors in the arterial vasculature.

13. The method of claim 1, wherein the activation of the baroreflex system comprises activating at least one of an afferent nerve emanating from a baroreceptor, a baroreceptor, a mechanoreceptor, a pressoreceptor, or another receptor which affects blood pressure, nervous system activity, or neurohormonal activity in a manner analogous to baroreceptors in the arterial vasculature.

14. The method of claim 1, wherein the baroreflex activation therapy comprises activating a baroreceptor located in at least one of a carotid sinus, aortic arch, heart, common carotid artery, subclavian artery, and brachiocephalic artery.

15. The method of claim 1, wherein the baroreflex activation therapy comprises activating a baroreceptor located in at least one of an inferior vena cava, superior vena cava, portal vein, jugular vein, subclavian vein, iliac vein, and femoral vein.

16. The method of claim 1, wherein the baroreflex activation device is implanted in the patient.

17. The method of claim 1, wherein the activation comprises at least one of electrical activation, mechanical activation, thermal activation, chemical activation, and biological activation.

18. The method of claim 1, wherein the parameter comprises any one or more of heart rate, blood pressure, ECG, oxygen saturation, blood pH, activity level, prone posture, supine posture, core body temperature, respiration rate, respiration depth, and blood CO2 level.

19. The method of claim 1, wherein the baroreflex therapy comprises a plurality of therapy regimens at least one of which provides therapy at substantially no energy to the patient.

20. The method of claim 1, wherein the therapy regimen comprises at least one or more intensity regimens responsive to one or more characteristics of pulses generated by the baroreflex activation device.

21. The method of claim 20, wherein the pulse characteristic includes one or more of duty cycle, pulse amplitude, pulse width, pulse frequency, pulse separation, pulse waveform, pulse polarity, and pulse phase.

22. The method of claim 1, wherein the monitoring of the patient'"'"'s condition comprises sensing the physiological response with one or more sensors over a period of time.

23. The method of claim 1, wherein the monitored parameter comprises heart rate.

24. The method of claim 1, wherein the monitored parameter comprises blood pressure.

25. The method of claim 22, wherein, the sensing is performed by a device comprising any one or more of extracardiac electrocardiogram, intracardiac electrocardiogram, pressure sensor, and accelerometer.

26. The method of claim 22, wherein, the activation of the baroreflex activation device is controllable by at least one of the patient and the healthcare provider.

27. The method of claim 1, wherein, the monitoring of the parameter comprises measuring at least one electrical potential difference occurring within the body.

28. The method of claim 1, wherein, the monitoring of the parameter comprises measuring a voltage difference between a first conductive element of the baroreflex activation therapy device and a second conductive element of the baroreflex activation device.

29. The method of claim 28, wherein the first conductive element comprises an electrode of the baroreflex activation device and the second conductive element comprises a conductive housing of the baroreflex activation device.

30. The method of claim 28, wherein the first conductive element comprises a first electrode of the baroreflex activation device and the second conductive element comprises a second electrode of the baroreflex activation device.

31. The method of claim 28, further comprising repeatedly measuring at least one electrical potential difference to obtain a digitized electrocardiogram waveform.

32. The method of claim 28, further identifying at least one R-wave in the electrocardiogram.

33. The method of claim 32, further comprising measuring a time interval between at least one pair of R-waves.

34. The method of claim 28, further comprising identifying at least one R-wave peak in the electrocardiogram.

35. The method of claim 34, further comprising measuring a time interval between at least one pair of R-wave peaks.

36. The method of claim 1, further comprising repeatedly measuring the value of the parameter to provide a digitized parameter waveform.

37. The method of claim 36, further comprising repeatedly measuring the value of the parameter;

comparing the measured value to a second threshold value; and

resuming application of baroreflex activation therapy if the measured value is greater than the second threshold value.

38. The method of claim 37, wherein the second threshold value is different than the threshold value.

39. The method of claim 37, wherein the second threshold value is greater than the threshold value.

40. A method for treating a patient, comprising:

activating a baroreflex system of the patient with a baroreflex activation device according to a baroreflex therapy comprising a plurality of baroreflex stimulation regimens wherein at least one of the regimens provides therapy at an intensity level different from another regimen;

establishing a target range for a patient parameter indicative of a physiological condition;

establishing a threshold range for the patient parameter;

monitoring the patient'"'"'s parameter; and

adjusting the baroreflex therapy in response to a value of the monitored parameter if the parameter value is outside of the threshold range.

41. The method of claim 40, wherein baroreflex therapy is delivered at an initial intensity level.

42. The method of claim 40, wherein the parameter is monitored over a period of time.

43. The method of claim 40, further comprising comparing the monitored parameter to the threshold range of the parameter.

44. The method of claim 40, wherein the monitored response comprises any one or more of heart rate;

blood pressure, ECG, oxygen saturation, blood pH, activity level, prone posture, supine posture, core body temperature, respiration rate, respiration depth, and blood CO2 level.

45. The method of claim 40, wherein the at least one or more intensity regimens comprises changing one or more characteristics of pulses generated to activate the baroreflex system of the patient.

46. The method of claim 40, wherein the delivery of the baroreflex therapy is by way of an open loop system, wherein the therapy is controllable by the patient or the healthcare provider.

47. The method of claim 40, wherein the delivery of the baroreflex therapy is by way of a closed loop system, wherein the therapy is controllable by a pre-programmed instructions.

48. The method of claim 40, wherein the monitoring of the patient'"'"'s condition comprises sensing the parameter with one or more sensors over a period of time.

49. The method of claim 45, wherein the pulse characteristic includes one or more of duty cycle, pulse amplitude, pulse width, pulse frequency, pulse separation, pulse waveform, pulse polarity, and pulse phase.

50. The method of claim 40, wherein the monitored parameter comprises heart rate.

51. The method of claim 40, wherein the monitored parameter comprises blood pressure.

52. The method of claim 43, further comprising discontinuing the baroreflex therapy if the monitored parameter is outside the threshold range.

53. The method of claim 43, further comprising comparing the monitored parameter to the parameter target range if the monitored parameter is greater than the threshold range.

54. The method of claim 52, wherein the patient parameter is continuously monitored over a period of time and compared to the threshold range to determine whether baroreflex therapy should resume.

55. The method of claim 53, wherein if the monitored parameter is at least equal to the target range, baroreflex therapy and the monitoring of the parameter continues.

56. The method of claim 53, wherein if the monitored parameter is not equal to the target range, the baroreflex therapy is delivered according to a baroreflex activation therapy regimen responsive to the value of the monitored parameter and the monitoring of the parameter continues.

57. The method of claim 53, wherein if the monitored parameter is greater than the target range, the baroreflex therapy is delivered according to a regimen delivering baroreflex activation therapy at a higher intensity.

58. The method of claim 53, wherein if the monitored parameter is less than the target range, the baroreflex therapy is delivered according to a regimen delivering therapy at a lower intensity.

59. A system for treating a patient, comprising:

a therapy circuitry for delivering baroreflex activation therapy to the patient;

a controller circuitry configured for applying the baroreflex activation therapy to the patient, the controller connectable to the therapy circuitry; and

a memory circuitry in communication with the controller and configured for storing information regarding the baroreflex activation therapy.

60. The system of claim 59, wherein the therapy circuitry comprises a pulse generator configured for generating stimulation pulses to activate the baroreflex system of the patient, wherein the pulse generator is configured for delivery of a plurality pulses having different intensity levels.

61. The system of claim 59, wherein the baroreflex activation therapy comprises a plurality of therapy regimens comprising different intensity levels, wherein at least one of the intensity levels is at or close to zero.

62. The system of claim 60, wherein the baroreflex activation therapy includes a plurality therapy regimens at least one of which is different than another regimen.

63. The system of claim 60, wherein the system further comprises at least one electrode assembly.

64. The system of claim 63, wherein the electrode assembly is locatable proximate one or more baroreceptors of the patient.

65. The system of claim 59, wherein the system further comprises a monitoring circuitry connectable to the controller circuitry.

67. The system of claim 65, wherein the sensor comprises one or more of extracardiac electrocardiogram, intracardiac electrocardiogram, pressure sensor, and accelerometer.

69. The system of claim 65, further comprising a switching circuitry connectable to the monitoring circuitry and the therapy circuitry for adjusting the baroreflex activation therapy based on the information received from the monitoring circuitry and the therapy circuitry.

70. The system of claim 69, wherein the switching circuitry is connectable to at least one electrode assembly locatable proximate one or more baroreceptors of the patient.

71. The system of claim 59, wherein the system is housed within a single housing.

72. The system of claim 59, wherein the system is implantable in the patient.

73. The system of claim 59, wherein the system is further configured for communication with other devices comprising:

cardiac rhythm management devices comprising cardiac resynchronization therapy (“

CRT”

) devices, cardioverters, defibrillators, pacemakers, and combinations thereof.

66. The system of system 65, wherein the system further comprises a sensor connectable to the monitoring circuitry and which is configured for sensing of the patient parameter which is indicative of a physiological condition.

68. The system of system 66, wherein the controller circuitry is configured to adjust the baroreflex activation therapy based on information received by way of the sensor.

74. A system for treating a patient, comprising:

a therapy circuitry for providing baroreflex activation therapy (BAT) to a body of a patient;

a monitoring circuitry that is capable of measuring a biopotential within the body of the patent for producing an electrocardiogram signal;

a switching circuitry coupled to the therapy circuitry and the measurement circuitry; and

a control circuitry coupled to the switching circuitry, the control circuitry configured for directing the switching circuitry to periodically connect one or more electrodes to the therapy circuitry for providing baroreflex activation therapy (BAT) to the body of the patient, and the control circuitry configured for directing the switching circuitry to periodically connect the one or more electrodes to the monitoring circuitry for measuring the biopotential within the body of the patent for producing the electrocardiogram signal.

75. A baroreflex activation therapy (BAT) system, comprising:

a therapy circuitry connected to a first therapy terminal and a second therapy terminal for producing a baroreflex activation therapy signal;

a measurement circuitry that is capable of measuring a voltage between a first measurement terminal and a second terminal; and

a switching circuitry connected to the first measurement terminal, the second terminal, the first therapy terminal, and the second therapy terminal;

the switching circuitry selectively coupling a first electrode and a second electrode to the first therapy terminal and the second therapy terminal, respectively, for providing baroreflex activation therapy to a body of a patient.

76. The system of claim 75, wherein the switching circuitry selectively couples the first electrode and a conductive housing of the BAT system to the first measurement terminal and the second measurement terminal, respectively, for measuring an electric potential difference within the body of the patient.

77. The system of claim 76, wherein the conductive housing comprises a hermetically sealed housing defining an interior.

78. The system of claim 77, wherein the therapy circuitry, the measurement circuitry, and the switching circuitry are all disposed in the interior of the housing.

79. The system of claim 75, wherein the switching circuitry selectively couples the first electrode and a third electrode to the first measurement terminal and the second measurement terminal, respectively, for measuring an electric potential difference within the body of the patient.

80. The system of claim 75, wherein the first electrode comprises an inner electrode of a BAT electrode assembly.

81. The system of claim 75, wherein the first electrode comprises an outer electrode of a BAT electrode assembly.

82. The system of claim 81, wherein the BAT electrode assembly comprises a sheet of flexible material and a plurality of electrodes secured over a first surface of the sheet.

83. The system of claim 82, wherein the plurality of electrodes comprises:

an inner electrode, a first outer electrode, and a second outer electrode, wherein

each electrode has a proximal end and a distal end, and wherein the inner electrode is located between the first outer electrode and the second outer electrode;

a first lead electrically connected to the proximal ends of the first outer electrode and the second outer electrode; and

a second lead electrically connected to the proximal end of the inner electrode.

84. The system of claim 83, wherein the plurality of electrodes are positioned on the sheet such that the proximal end of the first outer electrode and the distal end of the inner electrode are positioned proximate one another;

and the distal end of the first outer electrode and the proximal end of the inner electrode are positioned proximate one another.

85. A baroreflex activation therapy device, comprising:

a memory storing a threshold value associated with a physiological parameter of a patient;

a therapy circuitry for delivering baroreflex activation therapy to a body of the patient;

a sensor for measuring a value of a physiological parameter of the patient; and

a disable circuitry that disconnects the therapy circuitry from at least one patient electrode if the measured value is below the threshold value.

86. The system of claim 85, wherein the sensor comprises a pressure sensor.

87. The system of claim 85, wherein the sensor comprises a measurement circuitry connected to one or more electrodes for measuring a biopotential in the body of the patient.

88. A baroreflex activation therapy (BAT) system, comprising:

a therapy circuitry connected to a first therapy terminal and a second therapy terminal for producing a baroreflex activation therapy signal;

a controller connected to the therapy circuitry;

a sensor connected to the controller;

a switching circuitry connected to the controller; and

the switching circuitry being connected to the first sensor terminal and the second terminal, wherein the switching circuitry selectively couples a first electrode and a second electrode to the first therapy terminal and the second therapy terminal, respectively, for providing baroreflex activation therapy to a body of a patient.

89. The system of claim 88, wherein the sensor comprises a pressure sensor.