Closed Loop Chronic Electroacupuncture System Using Changes in Body Temperature or Impedance

• US 20140214134A1
• Filed: 02/27/2013
• Published: 07/31/2014
• Est. Priority Date: 03/12/2012
• Status: Abandoned Application

• Current Assignee: Valencia Technologies Corporation
• Original Assignee: Valencia Technologies Corporation
• Inventors: Peterson, David K. L.
• Application Number:
  US13/779,155
• Publication Number:
  US 20140214134A1
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61H 2201/5005 for controlling frequency distribution, modulation or interference of a driving signal
• CPC Class Codes: A61H 2201/5035 Several programs selectable
• CPC Class Codes: A61H 2201/5038 freely programmable by the user
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• CPC Class Codes: A61N 1/3782 producing a voltage above the power source level

Abstract

A closed loop electroacupuncture (EA) system monitors any change in sympathetic drive within the body of a patient undergoing EA stimulation. The sensed change in sympathetic drive is then used to adjust at least one parameter of the EA stimulation regimen in an appropriate manner that assists regulation of the patient'"'"'s autonomic nervous system (ANS). One manner of determining an increase in sympathetic drive is to monitor the body temperature at the skin. A decrease in skin temperature is indicative of increased sympathetic drive and/or exercise stress due to vasoconstriction in the subcutaneous vascular bed. An adjunct to monitoring skin temperature is to monitor subcutaneous tissue impedance. Subcutaneous tissue impedance increases during vasoconstriction. Thus, a sensed change in tissue impedance may be used by itself, or as a compliment to sensed changes in temperature, to provide feedback within the closed loop EA system to adjust the stimulation regimen.

Claims

1. An implantable electroacupuncture (EA) device adapted to be implanted at a specified acupoint of a patient, the electroacupuncture device including:

a housing;

a pair of electrodes formed as an integral part of the housing;

stimulation circuitry residing inside the housing and electrically coupled to the pair of electrodes, wherein the stimulation circuitry generates stimulation pulses that are delivered to body tissue through the pair of electrodes in accordance with a prescribed stimulation regimen;

at least one sensor residing within the housing, the sensor including means for sensing at least one physiological parameter of the patient; and

feedback means responsive to changes in the sensed physiological parameter for modifying the stimulation regimen in a way that maintains functionality of the patient'"'"'s autonomic nervous system (ANS).

2. The EA device of claim 1, wherein the at least one sensor comprises a temperature sensor that senses the temperature at or near the skin of the patient, and wherein the temperature sensed by the temperature sensor comprises the at least one physiological parameter used by the feedback means to modify the prescribed stimulation regimen.

3. The EA device of claim 2, further including a second sensor that includes means for measuring the impedance of the patient'"'"'s subcutaneous tissue at or near the housing, and wherein the feedback means monitors the tissue impedance measured by the second sensor, as well as the skin temperature sensed by the temperature sensor, and in response to specified changes in the skin temperature and tissue impedance adjusts when and how the prescribed stimulation regimen is modified.

4. The EA device of claim 3, wherein the stimulation regimen is modified by the feedback means only if the temperature sensed by the temperature sensor over a prescribed time period and the impedance sensed by the impedance means over the prescribed time period both indicate a need to modify the patient'"'"'s ANS in the same direction.

5. The EA device of claim 4, wherein the temperature sensed by the temperature sensor over the prescribed time period is weighted more than the impedance sensed by the second sensor over the prescribed time period in determining the magnitude of the adjustment made to the prescribed stimulation regimen.

6. The EA device of claim 4, wherein the temperature sensed by the temperature sensor over the prescribed time period is weighted less than the impedance sensed by the second sensor over the prescribed time period in determining the magnitude of the adjustment made to the prescribed stimulation regimen.

7. A method of operating an implantable electroacupuncture (EA) device, the EA device including a housing, at least two electrodes formed as an integral part of the housing, and stimulation circuitry residing within the housing coupled to the at least two electrodes, the method comprising:

implanting the EA device at a specified acupoint of a patient the wording in the doc submitted to the PTO, “

implanting the EA device at a specified target tissue stimulation point that is near an acupoint of a patient;

controlling the EA device so that it generates stimulation pulses that are delivered through the at least two electrodes to the patient'"'"'s body tissue at the specified acupoint in accordance with a specified stimulation regimen;

sensing a physiological condition of the patient that is related to the patient'"'"'s autonomic nervous system (ANS); and

adjusting the stimulation regimen in response to changes that are sensed in the patient'"'"'s physiological condition in a way that maintains functionality of the patient'"'"'s ANS.

8. The method of claim 7, further including sensing a second physiological condition of the patient that is also related to the patient'"'"'s ANS;

and adjusting the stimulation regimen in response to changes that are sensed in both the first and second physiological conditions.

9. The method of claim 8, wherein adjusting the stimulation regimen comprises adjusting the stimulation regimen only when the changes sensed in both the first and second physiological conditions both indicate a need to increase the output delivered by the stimulation regimen.

10. The method of claim 9, further including increasing the output of the stimulation regimen by an amount determined by a weighted combination of the changes sensed in the first and second physiological parameters.

11. The method of claim 10, wherein the step of increasing the output of the stimulation regimen comprises weighting changes sensed in the first and second physiological parameters equally in order to determine how much the output of the stimulation regimen is to be increased.

12. The method of claim 10, wherein the step of increasing the output of the stimulation regimen comprises weighting changes sensed in the first physiological parameter more than changes in the second physiological parameter in order to determine how much the output of the stimulation regimen is to be increased

13. The method of claim 10, wherein the step of increasing the output of the stimulation regimen comprises weighting changes sensed in the first physiological parameter less than changes in the second physiological parameter in order to determine how much the output of the stimulation regimen is to be increased.

14. The method of claim 8, wherein adjusting the stimulation regimen comprises adjusting the stimulation regimen only when the changes sensed in both the first and second physiological conditions both indicate a need to decrease the output delivered by the stimulation regimen.

15. The method of claim 14, further including decreasing the output of the stimulation regimen by an amount determined by a weighted combination of the changes sensed in the first and second physiological parameters.

16. The method of claim 15, wherein the step of decreasing the output of the stimulation regimen comprises weighting changes sensed in the first and second physiological parameters equally in order to determine how much the output of the stimulation regimen is to be decreased.

17. The method of claim 15, wherein the step of decreasing the output of the stimulation regimen comprises weighting changes sensed in the first physiological parameter more than changes in the second physiological parameter in order to determine how much the output of the stimulation regimen is to be decreased.

18. The method of claim 15, wherein the step of decreasing the output of the stimulation regimen comprises weighting changes sensed in the first physiological parameter less than changes in the second physiological parameter in order to determine how much the output of the stimulation regimen is to be decreased.

19. The method of claim 8, wherein sensing the first physiological condition comprises sensing skin temperature at or near the location of the implanted EA device.

20. The method of claim 8, wherein sensing the second physiological condition comprises sensing subcutaneous tissue impedance at or near the location of the two electrodes of the implanted EA device.