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

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.

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.

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.

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.