Implantable electroacupuncture system and method for treating depression and similar mental conditions

• US 9,173,811 B2
• Filed: 09/28/2012
• Issued: 11/03/2015
• Est. Priority Date: 09/29/2011
• Status: Active Grant

• Current Assignee: Valencia Bioscience, Inc.
• Original Assignee: Valencia Technologies Corporation
• Inventors: Greiner, Jeffrey H., Peterson, David K. L., Thenuwara, Chuladatta, Greiner, Stacy O.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): KIMBALL, JEREMIAH T
• Application Number:
  US13/630,522
• Publication Number:
  US 20140214118A1
• Time in Patent Office: 1,131 Days
• Field of Search: 607/2, 607 44- 46, 607/72, 128/907
• US Class Current: 1/1
• CPC Class Codes: A61H 2201/5005 for controlling frequency distribution, modulation or interference of a driving signal
• 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 1/36096 Mood disorders, e.g. depression, anxiety or panic disorder
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• 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 1/37223 Circuits for electromagnetic coupling
• 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
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

An implantable electroacupuncture device (IEAD) treats mental illness through application of stimulation pulses applied at a specified tissue location, including at least one of acupoints GV20 and EXHN3, or their underlying nerves. In one embodiment, the IEAD comprises an implantable, coin-sized, self-contained, leadless electroacupuncture device having at least two electrodes attached to an outside surface of its housing. The device generates stimulation pulses in accordance with a specified stimulation regimen. Power management circuitry within the device allows a primary battery, having a high internal impedance, to be used to power the device. The stimulation regimen generates stimulation pulses during a stimulation session of duration T3 minutes applied every T4 minutes. The duty cycle, or ratio T3/T4 is very low, no greater than 0.05. The low duty cycle and careful power management allow the IEAD to perform its intended function for several years.

Claims

1. An Implantable ElectroAcupuncture System (IEAS) adapted for treating depression through application of electroacupuncture (EA) stimulation pulses at a specified tissue location of a patient, comprising:

an implantable electroacupuncture (EA) device comprising a small, thin, leadless, hermetically-sealed coin-sized and coin-shaped housing containing self-contained circuitry including a primary power source having an internal impedance greater than 5 ohms, pulse generation circuitry powered by the primary power source, and a sensor that wirelessly senses the presence or absence of a magnetic field external to the housing, and uses the magnetic-field present/absent information to turn-on, turn-off and adjust the amplitude of the stimulation pulses generated by the pulse generation circuitry, wherein the self-contained pulse generation circuitry once turned on continuously generates stimulation sessions in accordance with a specified stimulation regimen;

a plurality of electrode arrays arranged in a symmetrical pattern, where an electrode array comprises an array of n conductive contacts electrically joined together to function jointly as one electrode, where n is an integer, on an outside surface of the EA device housing electrically coupled to the pulse generation circuitry on the inside of the EA device housing through at least one feed-through terminal passing through a wall of the hermetically-sealed housing, whereby stimulation pulses generated by the pulse generation circuitry are directed to the electrode arrays on the outside of the EA device housing in accordance with the specified stimulation regimen, which results in corresponding electrical fields being created around the electrode arrays that cause EA stimulation pulses to be directed to the specified tissue location in accordance with the specified stimulation regimen;

wherein the specified stimulation regimen defines how often a stimulation session comprising a stream of stimulation pulses is applied to the patient, the stimulation regimen requiring that the stimulation session have a duration of T3 minutes and a rate of occurrence of once every T4 minutes, wherein T3 is at least 10 minutes and the ratio of T3/T4 is no greater than 0.05; and

wherein the specified tissue location at which EA stimulation pulses are applied comprises at least one of acupoints GV20 and EXHN3, or their underlying nerves, or at least one of the three branches of the Trigeminal nerve known as the supratrochlear, supraorbital and infraorbital nerves.

2. The IEAS of claim 1 wherein the plurality of electrode arrays are located on a bottom surface of the housing of the implantable EA device.

3. The IEAS of claim 2 wherein a first one of the plurality of electrode arrays is centrally located on the bottom surface of the housing of the implantable EA device and a second one of the plurality of electrode arrays surrounds the first array.

4. The IEAS of claim 1 wherein the dimensions of the coin-sized and coin-shaped EA device are L×

W×

H, where L is a longest linear dimension, W is a shortest linear dimension measured in substantially the same plane as L, and H is a maximum height or thickness of the housing measured in a plane orthogonal with the plane where L and W are measured, and wherein L is no greater than about 25 mm, W is no less than about 15 mm and H is no greater than about 3 mm.

5. The IEAS of claim 1 wherein the primary power source of the EA device comprises a thin, coin-cell battery having a nominal output voltage of no more than 3.0 volts and an internal impedance of no less than about 5 ohms.

6. The IEAS of claim 5 wherein the pulse generation circuitry includes:

a boost converter circuit that boosts the nominal voltage of the primary battery to an output voltage V_OUT that is at least three times the nominal battery voltage;

a control circuit that selectively turns the boost converter circuit OFF and ON to limit the amount of current that may be drawn from the primary battery; and

an output circuit powered by V_OUT and controlled by the control circuit that generates the stimulation pulses as defined by the specified stimulation regimen.

7. The IEAS of claim 6 wherein the stimulation pulses generated by the pulse generation circuit and delivered through the plurality of electrode arrays into a load at the specified tissue location comprise voltage pulses having a voltage amplitude of no less than about 1 V and no greater than about 15 V.

8. The IEAS of claim 6 wherein the stimulation pulses generated by the pulse generation circuit and delivered through the plurality of electrode arrays into a load at the specified tissue location comprise current pulses having a current amplitude of no less than about 1 milliampere (mA) and no greater than about 15 mA.

9. The IEAS of claim 8 wherein the primary battery has sufficient capacity to power the pulse generation circuitry in accordance with the specified stimulation regimen for a minimum of 2 years.

10. The IEAS of claim 1 wherein the duration of the stimulation session T3 varies between 20 minutes and 72 minutes if the rate of occurrence of the stimulation session T4 is set to a value between 1,440 minutes and 20,160 minutes;

and wherein T3 varies between 10 minutes and a maximum T3 value, T3(max) if T4 is set to a value between 720 minutes and 1,440 minutes, wherein the value of T3(max) varies as a function of T4 as defined by the equation;

T3(max)=0.05*T4.

11. The IEAS of claim 1 further including an external magnetic field generation device adapted to selectively generate an external magnetic field of sufficient magnitude to be sensed by the sensor within the implantable EA device.

12. The IEAS of claim 11 wherein the sensor within the implantable EA device comprises a magnetic field sensor, and wherein the external control device comprises a magnet.

13. A method for treating at least one of the following mental disorders of a patient:

major depression disorder (MDD), generalized anxiety disorder (Anxiety), bipolar disorder, post-traumatic stress disorder (PTSD), schizophrenia, and obsessive compulsive disorder (OCD), comprising the steps of;

(a) implanting a small, thin, leadless, self-contained electroacupuncture (EA) device in the patient below the patient'"'"'s skin at or near at least one specified target tissue location, the EA device being housed within an hermetically-sealed case that is coin-sized and coin-shaped, having a diameter of no more than about 25 mm and a thickness of no more than about 2.5 mm, the EA device further having a symmetrical electrode configuration integrally formed on an outside surface of its case;

(b) enabling the EA device to generate stimulation sessions at a duty cycle that is less than or equal to 0.05, wherein each stimulation session comprises a series of stimulation pulses, wherein the duty cycle is the ratio of T3/T4, where T3 is the duration of each stimulation session, and T4 is the duration between stimulation sessions;

(c) delivering the stimulation pulses of each stimulation session to the at least one specified target tissue location through the symmetrical electrode configuration located on its case; and

(d) continuing to deliver stimulation sessions of duration T3 minutes at a rate of once every T4 minutes in a slow, methodical and prolonged manner that is adapted to gradually condition and remodel the patient'"'"'s central nervous system so as to produce a sustained therapeutic benefit for the treatment of the patient'"'"'s mental disorder.

14. The method of treating at least one of the mental disorders MDD, Anxiety, bipolar disorder, PTSD, schizophrenia, and OCD of claim 13 wherein the at least one specified target tissue location at which the stimulation pulses are applied is selected from the group of target tissue locations consisting of acupoints EXHN3 and GV20, the nerves underlying acupoints EXHN3 and GV20, and the three branches of the Trigeminal nerve called the infraorbital, the supraorbital and the supratroclear.

15. The method of treating at least one of the mental disorders MDD, Anxiety, bipolar disorder, PTSD, schizophrenia, and OCD of claim 13 further comprising forming the symmetrical electrode configuration to include a central electrode array, and an annular electrode array that surrounds the central electrode array, and wherein the closest spacing between an edge of the central electrode array and an edge of the annular electrode array comprises at least 5 mm.

16. The method of treating at least one of the mental disorders MDD, Anxiety, bipolar disorder, PTSD, schizophrenia, and OCD of claim 13 further including setting the time T4, the time between stimulation sessions, to be at least 1440 minutes but no longer than 20,160 minutes.

17. The method of treating at least one of the mental disorders MDD, Anxiety, bipolar disorder, PTSD, schizophrenia, and OCD of claim 16 further including setting T3, the duration of the stimulation session, to toggle between a first value T3₁ for a first stimulation session duration and a second value T3₂ for a second stimulation session duration, with the value T3₁ being used every other stimulation session, whereby a time line of the method of treating mental illness follows a sequence T3₁-T4-T3₂-T4-T3₁-T4-T3₂-T4-. . . and so on, where T4 is the time period between stimulation sessions.

18. The method of treating at least one of the mental disorders MDD, Anxiety, bipolar disorder, PTSD, schizophrenia, and OCD of claim 17 where T3₁ is set to a value that ranges between 10 minutes and 40 minutes, and T3₂ is set to a value that ranges between 30 minutes and 60 minutes.

19. The method of treating at least one of the mental disorders MDD, Anxiety, bipolar disorder, PTSD, schizophrenia, and OCD of claim 16 further including dividing T3, the duration of the stimulation session, into smaller segments of time, T31, T32, T33 . . . T3n, where n is an integer, such that T3=T31+T32+T33+. . . T3n, and wherein during each segment of time the stimulus pulse is delivered at a different frequency than is delivered during the other segments of time, whereby over the total time of the stimulation session T3, the stimulation pulses are delivered at n different frequencies.

20. The method of treating at least one of the mental disorders MDD, Anxiety, bipolar disorder, PTSD, schizophrenia, and OCD of claim 13 further including setting the time T3, the duration of the stimulation sessions, to be at least 10 minutes but no longer than a maximum value, T3(max), where the value of T3(max) is adjusted, as needed, to maintain the duty cycle, the ratio of T3/T4, at a value no greater than 0.05, wherein T3(max) is equal to 72 minutes if T4, the time period between stimulation sessions, is between 1,440 minutes and 20,160 minutes;

and setting T3(max) to a value set by the equation T3(max)=0.05*T4 when T4 is between 720 minutes and 1,440 minutes.

21. The method of treating at least one of the mental disorders MDD, Anxiety, bipolar disorder, PTSD, schizophrenia, and OCD of claim 20 further comprising setting T4, the time period between stimulation sessions, to toggle between a first value T4₁ and a second value T4₂, with the value T4₁ being used after every other stimulation session, whereby a time line of the method of treating mental illness follows a sequence T3-T4₁-T3-T4₂-T3-T4₁-T3-T4₂-T3-T4₁. . . and so on, where T3 is the duration of the stimulation sessions.

22. The method of treating at least one of the mental disorders MDD, Anxiety, bipolar disorder, PTSD, schizophrenia, and OCD of claim 21 where T4₁ is set to a value that ranges between 720 minutes and 10,080 minutes, and T4₂ is set to a value that ranges between 1,440 minutes and 20,160 minutes.

23. The method of treating at least one of the mental disorders MDD, Anxiety, bipolar disorder, PTSD, schizophrenia, and OCD of claim 13 further including manually starting and stopping the stimulation sessions within parameter boundaries that set a minimum duration, T3(min), for the stimulation session and a maximum duration, T3(max), for the stimulation session;

as well as a minimum time period, T4(min), between stimulation sessions and a maximum time period, T4(max), between stimulation sessions, the method comprising;

(a) manually starting a stimulation session at any time after an initialization event;

(b) manually stopping the stimulation session started in step (a) at any time after T3(min) has elapsed, or allowing the stimulation session started in step (a) to automatically stop after T3(max) has elapsed;

(c) manually starting a new stimulation session at any time after T4(min) has elapsed since the stopping of the stimulation in step (b), or allowing a new stimulation session to automatically start after T4(max) has elapsed;

(d) repeating steps(b) and (c) for so long as the method for treating mental illness is to be continued, or aborting the treatment by manually shutting down the treatment.

24. A method of treating at least one of the following mental disorders of a patient:

major depression disorder (MDD), generalized anxiety disorder (Anxiety), bipolar disorder, post-traumatic stress disorder (PTSD), schizophrenia, and obsessive compulsive disorder (OCD);

the method using a small, leadless, coin-sized and coin-shaped implantable electroacupuncture device (IEAD) powered by a small disc primary battery having a specified nominal output voltage of about 3 volts, and having an internal impedance of at least 5 ohms, the IEAD being configured, using electronic circuitry within the IEAD, to generate stimulation pulses in accordance with a specified stimulation regimen and apply the stimulation pulses through at least two electrodes formed in a symmetrical configuration on an outside surface of the IEAD, said at least two electrodes comprising at least one cathode electrode and at least one anode electrode, said method comprising;

(a) implanting the IEAD below a skin surface of the patient at or near a target tissue location selected from the group of target tissue locations consisting of;

acupoint EXHN3, acupoint GV20, the nerves underlying acupoints EXHN3 and GV20, and the three branches of the Trigeminal nerve known as the infraorbital, the supraorbital and the supratrochlear nerves,

(b) enabling the lEAD to provide electroacupuncture (EA) stimulation pulses in accordance with a stimulation regimen that provides a stimulation session having a duration of T3 minutes at a rate of once every T4 minutes, where the ratio of T3/T4 is no greater than 0.05, and wherein T3 is at least 10 minutes and no greater than 60 minutes, and

(c) continuing to apply the EA stimulation pulses in accordance with the specified stimulation regimen by continuously delivering stimulation sessions of duration T3 minutes at a rate of once every T4 minutes in a slow, methodical and prolonged manner that gradually conditions and remodels the patient'"'"'s central nervous system so as to produce a sustained therapeutic benefit for the treatment of the patient'"'"'s mental disorder.

25. The method of claim 24 further including setting the stimulation pulses during a stimulation session to have a duration of T1 seconds, that occur at a rate of once every T2 seconds, wherein T1 is 0.1 to 2.0 milliseconds, and T2 is 100 to 1000 milliseconds.

26. The method of claim 25 wherein the time T2 varies during a stimulation session, whereby a frequency of the stimulation pulses varies during the stimulation session.

27. The method of claim 24 further including controlling the electronic circuits within the IEAD to limit an instantaneous current drawn from the small disc primary battery so that the output voltage of the primary battery does not drop more than about 11% below the output voltage of the primary battery when current is being drawn from the primary battery, where the output voltage of the primary battery is equal to the specified nominal output voltage of the primary battery less the voltage drop caused by the instantaneous current flowing through the internal impedance of the primary battery.

28. The method of claim 27 wherein the electronic circuitry within the IEAD includes a boost converter circuit, and wherein the method of controlling the electronic circuits within the IEAD to limit the instantaneous current drawn from the battery comprises switching the boost converter circuit between an ON state and an OFF state.

29. A method of assembling an implantable electroacupuncture device (IEAD) in a coin-sized and coin-shaped hermetically-sealed, housing having a diameter of no more than 25 mm and a thickness of no more than 2.5 mm, the housing having at least one feed-through pin assembly radially passing through an edge wall of the coin-sized and coin-shaped thin housing, the IEAD being adapted for use in treating mental disorders of a patient, the method comprising the steps of:

(a) forming a thin coin-sized and coin-shaped housing having a bottom case and a top cover plate, the bottom case having an edge wall around its perimeter that extends at right angles from the bottom case, the edge wall having a height no more than 2.5 mm, the top cover plate being adapted to fit over an upper edge of the edge wall;

(b) forming a recess in the edge wall of the coin-sized and coin-shaped housing;

(c) placing a feed-through assembly within the recess so that a feed-through pin of the feed-through assembly electrically passes through the edge wall of the recess at a location that is separated from where the edge wall of the housing is designed to contact the top cover plate;

(d) placing electronic pulse generation circuitry and a primary battery within the space bounded by the bottom case and the perimeter edge wall, including electrically connecting the pulse generation circuitry to one end of the feed-through pin; and

(e) welding the top cover plate to the upper edge of the edge wall, thereby hermetically sealing the pulse generation circuitry and primary battery within the coin-sized and coin-shaped housing.

30. An Implantable ElectroAcupuncture System (IEAS) adapted for treating at least one of the following mental disorders of a patient:

major depression disorder (MDD), generalized anxiety disorder (Anxiety), bipolar disorder, post-traumatic stress disorder (PTSD), schizophrenia, and obsessive compulsive disorder (OCD);

the IEAS comprising

(a) an external component comprising an electromagnetic field generator, and

(b) a coin-sized and coin-shaped implantable component having a diameter of less than 25 mm, and a thickness of no more than 2.5 mm, wherein the coin-sized and coin-shaped implantable component comprises;

a coin-sized and coin-shaped housing made of a bottom part, a top part and a side wall that are welded together to create an hermetically-sealed, closed container,

at least one feed-through terminal that passes through a portion of the side wall, and which allows electrical connection to be made between the inside of the closed container and a location on the outside of the closed container,

self-contained electronic circuitry inside of the closed container that, once enabled and powered, generates stimulation pulses during a stimulation session, the stimulation session having a duration of T3 minutes, wherein T3 is at least 10 minutes, and wherein the electronic circuitry generates a new stimulation session at a rate of once every T4 minutes, where the ratio of T3/T4 is no greater than 0.05, wherein the stimulation pulses are coupled to the at least one feed-through terminal,

a sensor on the inside of the closed container adapted to sense a presence or absence of an electromagnetic field,

a primary power source inside of the closed container that provides operating power for the electronic circuitry, the primary power source having an internal impedance greater than 5 ohms, and

a symmetrical electrode configuration formed on an outside surface of the bottom part and side wall of the hermetically-sealed, closed container, the symmetrical electrode configuration including a central electrode surrounded by a ring electrode, the ring electrode being located on the side wall and being electrically connected to the at least one feed-through terminal, whereby the stimulation pulses contained in the stimulation sessions are made available through the symmetrical electrode configuration to stimulate body tissue in contact with or near the plurality of electrodes on the outside of the closed housing when the coin-sized and coin-shaped implantable component is implanted in body tissue; and

wherein, the coin-sized and coin-shaped implantable component of IEAS is adapted to be implanted at a specified tissue location and the external component of the IEAS is adapted to generate an electromagnetic field which, when sensed by the sensor inside of the implantable component, conveys information to the electronic circuitry inside of the implantable component that controls when the stimulation sessions are applied through the symmetrical electrode configuration.

31. The IEAS of claim 30 further including at least one recess in the side wall of the coin-sized and coin-shaped housing where the at least one feed-through terminal passes, the recess providing thermal and mechanical isolation for the feed-through terminal when the top and bottom parts and side wall of the housing are welded together.

32. The IEAS of claim 30 wherein the central electrode has a surface area of at least 12.6 mm², and wherein the spacing between the closest edges of the central electrode and the ring electrode is at least 5 mm.