Acupuncture is an ancient medical art dating back more than 2000 years.

Traditionally, points in the human body (herein called acupuncture points) were reached by piercing the body with fine wires or needles. The needles were then rotated or oscillated about their longitudinal axes, for example by rubbing an exposed end of a needle between a thumb and finger, to stimulate the acupuncture points.

Stimulation of specific acupuncture points has been shown in several studies to have great utility as adjuvant therapy to conventional medical treatments such as nausea and vomiting, postoperative pain, headache, smoking cessation, erectile dysfunction, depression, male fertility, dysmenorrhea, and stomach acid secretion. Great impetus to the use of acupuncture was generated when the National Institutes of Health Consensus Conference on Acupuncture in 1997 showed efficacy of acupuncture in adult postoperative and chemotherapy nausea and vomiting and in postoperative dental pain, and that there were other situations, such as addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma, in which acupuncture may be useful as an adjunct treatment or an acceptable alternative or be included in a comprehensive management program.

The publications described above and listed below are incorporated herein by reference: Hyde, E., Acupressure therapy for morning sickness. A controlled clinical trial. J Nurse Midwifery, 1989.34 (4): p. 171-8.

Schlager, A., T. Offer, and I. Baldissera, Laser stimulation of acupuncture point P6 reduces postoperative vomiting in children undergoing strabismus

surgery. Br J Anaesth, 1998.81 (4): p. 529-32.

De Aloysio, D. and P. Penacchioni, Morning sickness control in early pregnancy by Neiguan point acupressure. Obstet Gynecol, 1992.80 (5): p. 852-4.

Dundee, J. W., et al., Acupuncture prophylaxis of cancer chemotherapy- induced sickness. J R Soc Med, 1989.82 (5): p. 268-71.

Chen, S. C., et al., Aqueous acupuncture for postoperative pain-a matched controlled trial. Kao Hsiung I Hsueh Ko Hsueh Tsa Chih, 1991.7 (9): p. 466-70.

Chen, L., et al., The effect of location of transcutaneous electrical nerve stimulation on postoperative opioid analgesic requirement: acupoint versus nonacupoint stimulation. Anesth Analg, 1998. 87 (5): p. 1129-34.

Christensen, P. A., et al., Electroacupuncture and postoperative pain. Br J Anaesth, 1989.62 (3): p. 258-62.

Vincent, C. A., A controlled trial of the treatment of migraine by acupuncture. Clin J Pain, 1989.5 (4): p. 305-12.

Waite, N. R. and J. B. Clough, A single-blind, placebo-controlled trial of a simple acupuncture treatment in the cessation of smoking [see comments]. Br J Gen Pract, 1998. 48 (433): p. 1487-90.

Kho, H. G., et al., The use of acupuncture in the treatment of erectile dysfunction. Int J Impot Res, 1999.11 (1): p. 41-6.

Luo, H., et al., Clinical research on the therapeutic effect of the electro- acupuncture treatment in patients with depression. Psychiatry Clin Neurosci, 1998.

52 Suppl : p. S338-40.

Siterman, S., et al., Effect of acupuncture on sperm parameters of males suffering from subfertility related to low sperm quality. Arch Androl, 1997.39 (2): p. 155-61.

Helms, J. M., Acupuncture for the management of primary dysmenorrhea.

Obstet Gynecol, 1987.69 (1) : p. 51-6.

Tougas, G., et al., Effect of acupuncture on gastric acid secretion in healthy male volunteers. Dig Dis Sci, 1992.37 (10): p. 1576-82.

NIH Consensus Conference. Acupuncture. Jama, 1998. 280 (17): p. 1518-

24.

Omura, Y., Simple custom-made disposable surface electrode system for non-invasive"electro-acupuncture"or TNS and its clinical applications including treatment of cephalic hypertension and hypotension syndromes as well as temporo- mandibular joint problems, tintinitus, shoulder and lower back pain, etc. Acupunct Electrother Res, 1981.6 (2-3): p. 109-34.

However, many patients resist acupuncture primarily due to a fear of its needling or a contraindication for acupuncture using acupuncture needles (e. g., bleeding disorders, active infection). The needle phobic pediatric patient, in particular, is extremely reluctant. Therefore, electric stimulation of acupuncture points from the skin or surface of a body without invasive needles has been tried.

The following patents on electric stimulation inside a human body from the skin or surface of the body at least acupuncture-like without needles and considered to be the references most pertinent to my invention are also incorporated herein by reference.

Wilson U. S. Pat. No. 4,398,545, issued on August 16,1983, illustrates a bandage type device designed to block pain impulses originating from an injury.

From its Abstract: A bandage to be applied adjacent to an injured portion of a patient's body contains electronic circuitry which delivers electric pulses into the body to block or mask the pain arising from the injury. The bandage includes an inner unit adapted to be applied directly onto the patient's skin and a removable outer unit adapted to be applied upon the inner unit. The inner unit includes spaced apart conductive portions which contact the patient's skin. The outer unit includes a power source and an electronic circuit which applies a voltage output to the conductive portions of the inner unit. The voltage output is transmitted through the conductive portions to the patient's skin to cause low current electrical pulses within the patient's body to block or mask the pain arising from the injury.

The device includes: 1) an inner and outer unit, the inner unit including two flat electrodes with

opening for electrolyte (conductive) solution and the outer unit containing electronic circuitry; and 2) two large electrodes patches which are used for skin contact and to direct current flow.

The device does not include: 1) an indication or application for stimulation of acupuncture points; it is designed to be used for muscular pain and is applied directly to the affected area; and 2) concentric electrodes about a center electrode and an outer circumferential electrode, both electrodes using an electrolytic gel, which allows a low resistance connection between the electrode and the skin.

The Bertolluci U. S. Pat. No. 4,981,146 issued on January 1, 1991, illustrates a watch like device designed to alleviate nausea. From its Abstract : A nausea control device is provided in the form of a watch-like housing and related attachment band for mounting onto the human wrist, wherein the device includes electronic circuitry for imparting electrical impulses via positive and negative electrodes to the pericardium six (P6 a. k. a. MH6) acupuncture point for alleviating nausea. Batteries within the housing power the electric circuitry, and a manually operable switch on the housing controls on/off and pulse amplitude.

The device includes: 1) an inner and outer unit, the inner unit including linear arranged electrodes for a specified frequency (70Hz) and pulse width (80ns) and the outer unit containing electronic circuitry; 2) surface stimulation of an acupuncture point; and 3) variable amplitude adjustment.

The device does not include: 1) a self-adhering device which can be positioned anywhere on the body, including many other acupuncture points in addition to MH6.

2) concentric electrodes; and 3) provisions for variable frequencies and pulse widths as required for the

specific acupuncture point to be stimulated.

The references cited in the Bertolluci patent include: the Hoffmann U. S. Pat. No. 3, 107,672, and the Moss U. S. Pat. No.

3,424,165, which are directed toward stimulating and firming the muscles for cosmetic purposes; the Oseau U. S. Pat. No. 3,911,910, which teaches devices designed to relieve involuntary muscle spasticity; the Crossley U. S. Pat. No. 4,715,367, which teaches devices to assist in refraining from undesirable habits by utilizing painful or alarming electrical stimulation; and the Hathaway U. S. Pat. No. 2,223,447, which illustrates a non-portable radiotherapy system designed for treatment of certain diseases.

None of these are designed for use specific to acupuncture points, none use a concentric arrangement of outer and inner electrode contacts filled with a gel electrolytic solution and none are able to be used without assistance.

However, the Omura publication incorporated above describes a disposable flat surface electrode to be constructed by the practitioner out of adhesive tape, aluminum foil and thumb tacks for use in electro-acupuncture. It is similar to the Wilson U. S. Pat. No. 4,398,545 in design and application and, therefore, has the same differences from my invention.

SUMMARY OF THE INVENTION My device provides a non-invasive means for stimulating a selected acupuncture point. It can be used to stimulate almost all acupuncture points.

Through use of its novel electrode configuration, electrical impulses are delivered to the selected acupuncture point with limited current loss, thus lowering the power requirements of the device. The electrode configuration also provides for easy measurement of a body dimension unit termed a cun (defined as the length of the middle phalangeal bone of the middle finger) that is used in acupuncture procedures. The low power requirements will allow for a small self-contained power and/or control unit (e. g., a stimulator) as well as use of a standard external

power supply or entire stimulator.

Although many of these devices can be used together at separate acupuncture points for what is often referred to as an energetic treatment, a major intent of this device is stimulation of one acupuncture point at a time.

The device, which is preferably disc shaped, has two primary electrically insulative layers. A first layer has one side, which is the lower side in use, for adhering to, e. g., a patient's skin surface and through which holes are provided and, on the opposite side, a second, upper layer which consists of a plastic (e. g., polyester) disc on the underside of which electrical circuitry is preferably printed so that the electrical circuitry is sandwiched between the layers. The first, lower layer is preferably a foam with non-conductive adhesive on both sides: the bottom side for adhering to the skin and the top side for adhering to the upper polyester disc. The holes through this lower foam layer include, preferably, eight holes spaced concentrically about one central hole in the middle of the lower foam layer.

All these holes are, preferably, overfilled with an electrically conductive gel that projects from the lower foam layer. The conductive circuitry preferably printed on the underside of the upper layer provides a series connection to the gel in each of the eight concentric holes and a separate connection to the gel in the center hole when the upper layer is adhered to the lower layer. The printed circuitry may be a silver/silver chloride polymer film, also provides for a tab (s) which can be permanently or temporarily affixed to an integral or remote simulator through direct contact or wire leads.

The electrode disc may be received on the base of a power and/or control unit for holding the unit thereon, whereby the electrode disc can be adhered at an acupuncture point on a body and the power and/or control unit mounted thereon for providing a self-contained acupuncture treatment thereto.

Examples of several acupuncture points for which this device is applicable include (but not limited to): MH6 (Nei Guan): Location: On the anterior antebrachial region, 2 cun proximal to the anterior

crease of the wrist, on the ulnar side of the tendon of the flexor carpi radialis, between this tendon and the tendon of the panaris longus (when it exists); Indications: Important for mental-emotional symptoms, asthma, gastritis, nausea, motion sickness, hiccoughs, heartburn, or tennis elbow; Frequency: 2.5 Hz to 100 Hz; CV-12 (Zhon Guan): Location: On the anterior midline, 4 cun above the umbilicus, midway between the umbilicus and the xiphisternal synchondrosis; Indications: Stomach pain, vomiting, gastritis, stomach or duodenal ulcers, abdominal distension, diarrhea, anorexia, dysentery, malnutrition, loss of appetite, belching, or retention of food in stomach; Frequency: 2.5 Hz to 100 Hz; LI-4 (He Gu): Location: On the dorsum of the first interosseus space of the hand, at the level of the midpoint of the shaft of the 2nd metacarpal bone, on the belly of the first interosseus dorsalis muscle; Indications: headaches, sinus problems, toothaches, mouth and tooth disorders, urticaria and skin problems, tonsillitis, pharyngitis, epistaxis, rhinitis, sinusitis, nose diseases, nosebleed, conjunctivitis and eye problems, facial paralysis, tintinitus, hearing loss, diarrhea, constipation, insomnia, emotional agitation, or depression; Frequency: 2.5 Hz to 100 Hz; TH-5 (Wai Guan): Location: On the posterior antebrachial region, 2 cun proximal to the dorsal crease of the wrist, on the line connecting TH-4 and the tip of the olecranon; Indications: stiffness in elbow, forearm and wrist, shoulder problems. occipital headaches, migrating to forehead and eyes, tintinitus, ENT problems, deafness, otitis, abdominal pain, constipation or tennis elbow; Frequency: 2.5 Hz to 100 Hz; SP-6 (San Yin Jiao) :

Location: On the medial side of the leg, posterior to the medial margin of the tibia, 3 cun above the prominence of the medial malleolus; Indications: immune and endocrine stimulation, reproductive problems, dysmenorrhea, leukorrhea, orchitis, hernia, spermatorrhea, urinary problems (incontinence or obstruction), lower abdominal pain, diarrhea and abdominal distension, or borborygmus; Frequency: 2. 5 Hz to 500 Hz; LR-3 (Tai Chong): Location: On the dorsum of the foot, on the first interosseus space of the metatarsus, in a depression distal to the intermetatarsal joint between the 1st and 2nd metatarsal bones; Indications: anxiety, insomnia, all foot problems, liver or gall bladder disease, abdominal pain and swelling, nausea and vomiting, all eye problems, nasal congestion due to allergies, allergic headaches, particularly ocular or at top of head, myopia, glaucoma, and visual disorders, insomnia, migrane headaches, irritability, dizziness, seizures in children, sore throat, menstrual disorders, slow labor, genital pain, testicular pain and swelling, hernia pain, thoracic fullness, abdominal pain, diarrhea, enuresis, urinary block, or endocrine and metabolic disorders; Frequency: 2. 5 Hz to 100 Hz; ST-36 (Zu San Li): Location: On the superolateral aspect of the anterior surface of the leg, 3 cun distal to the apex of the patella and one finger-breadth lateral to the tibial tuberosity; Indications: abdominal pain, appendicitis, nausea and vomiting, gastritis, pain, diarrhea, constipation, dyspepsia, gastric ulcer. hepatitis and cholecystitis. all pain problems, fatigue, dizziness, convulsions, needle shock, asthma and respiratory problems, weight loss, febrile diseases, arterial hypertension, hemiplegia, edema, or epilepsy; Frequency: 2. 5 Hz to 500 Hz; and

ST-43 (Xian Gu): Location: On the dorsum of the foot, on the 2nd interosseus space of the metatarsus, in a depression distal to the intermetatarsal joint between the 2nd and 3rd metatarsal bones; Indications: agitation, insomnia, nightmares, night sweats, fever, or redness of face or eyes; Frequency: 2.5 Hz to 100 Hz.

BRIEF DESCRIPTION OF THE DRAWING The above and other features of the invention will now be described with reference to a drawing of embodiments that illustrate but do not limit the invention and in which: Fig. 1 is a top plan view of a first embodiment of the device in a shipping condition; Fig. 2 is a top plan view of a second embodiment of the device; Fig. 3 is a top plan view of a third embodiment of the device; Fig. 4 is a front and sides elevational view of the first embodiment of the device in the shipping condition, the rear and sides elevational view being a mirror image and, therefore, not shown; Fig. 5 is a front and sides elevational view of the second and third embodiments, the rear and sides elevational view being a mirror image and, therefore, not shown; Fig. 6 is a bottom plan view of the first embodiment of the device in the shipping condition; Fig. 7 is an enlarged sectional elevational view of the first embodiment of the device line 7-7 in Fig. 1 in the shipping condition and showing in phantom tabs being raised into a use condition; Fig. 8 is a front and sides elevational view of the first embodiment of the device in a use condition together with electrode clamps and wire leads therefor, the rear and sides elevational view being a mirror image and, therefore, not shown; Fig. 9 is a front and sides elevational view of the first embodiment of the

device in the use condition together with a complementary power and/or control unit therefor; Fig. 10 is an enlarged rear elevational view, partly cut away and partly in section, of the first embodiment of the device in the use condition with the power and/or control unit; Fig. 11 is a top plan view of the power and/or control unit; and Fig. 12 is a bottom plan view of the power and/or control unit without the first embodiment of the device.

DESCRIPTION OF THE INVENTION Each preferred embodiment of the device has an electrode disc 10, 1 Oa or 10b shown by itself in Figs. 1-7. Each electrode disc has an electrically insulating disc-shaped transparent polyester layer 12,12a, 12b about 3-7 mil thick on one surface that is the top in use. The underside at least of the polyester layer may be adhesion treated. A congruent, electrically insulating polyethylene foam disc with skin contact pressure sensitive adhesive on both sides forms a lower layer 14,14a, 14b of each embodiment. The adhesive on one side adheres to the polyester layer 12,12a, 12b and the adhesive on the opposite surface that is on the bottom in use contacts and removably adheres to a patient's skin. The polyethylene foam may be about 32 mil thick with an adhesive tack in gm/sq cm of about 400 on both sides.

In another embodiment (not shown) the layers are not congruent and/or disc shaped.

An electrically conductive gel 16,16a, 16b overfills a central hole through the adhesive foam layer to project from the lowermost (in use), skin-contacting surface thereof. Further gel 18, 18a, 18b overfills a series of further holes (eight in the drawn embodiments) through the adhesive foam layer spaced about a circle centered on the hole for the central gel 16,16a, 16b. A suitable gel comprises a conductive hydrogel polymer as for example provided for skin contact devices by First Water Limited of Ramsbury, Marlborough, U. K.

The central gel filled hole 16,16a, 16b is connected to one end of a silver/silver chloride polymer film electrical conductor 20,20a, 20b that is printed

on the underside of the polyester layer 12, 12a, 12b to be sandwiched between the polyester layer and the adhesive foam layer 14,14a, 14b. The conductor 20,20a, 20b projects radially from the one end connected to the central gel-filled hole to an opposite, tab end 22,22a, 22b. In the first embodiment, the plastic layer is cut away over the tab end, whereby the tab end can be raised from a layer-parallel shipping condition shown in Figs. 1,6 and 7 to a projecting use condition shown in Figs. 7,8 and 10 by a folding movement indicated by the arrow 24 in Fig. 7. In the second and third embodiments, the top polyester layer 12a, 12b projects radially from the disc in tabs to support the silver/silver chloride polymer film electrical conductor tab ends 22a, 22b printed on the undersurface of the tabs of the polyester layers 12a, 12b as shown in Fig. 2,3 and 5.

One end of another, similar silver/silver chloride conductor 26,26a, 26b is connected to one of the further gel filled holes 18,18a, 18b and projects radially to a separate tab end 28, 28a, 28b. In the first embodiment, the polyester layer 12 is cut away over the tab end 28 so that it, too, may be folded as shown by arrow 30 in Fig. 7 from a layer-parallel shipping condition to a projecting, use condition. In the second and third embodiments, the tab ends 28a, 28b are supported by the tabs of the polyester layer in spaced parallel relation to the tab ends 22a, 22b of the conductors from the central gel filled holes.

The further gel filled holes 18,18a, 18b are also connected to each other by silver/silver chloride polymer film conductors 32,32a, 32b printed on the polyester layer between and over the holes and sandwiched between the layers.

In the first embodiment, the conductor 32 extends diagonally from a radially inward portion of one gel filled hole 18 to a radially outward portion of a successive gel filled hole 18 about the circular spacing therebetween and over each gel filled hole. This diagonal arrangement between the gel filled holes and the circular arrangement of the gel filled holes define at about longitudinal centers of the gel filled holes 18 an effective circle that is an integral multiple (including of 1) of an average cun radially from the central gel filled hole 16. In this way, the device provides a visual cun-measuring tool for positioning it in cun dimensions

relative to an acupuncture point.

In the second embodiment, the conductor 32a extends from the one end of the conductor 26a connected to one gel filled holes 18a across and over each of the gel filled holes 18a to an opposite end on the tab of the polyester layer. Since the resulting circle of the conductor 32a is narrower than the diameters of the holes, a cun-indicating circle from the central gel filled hole is clearly defined and since both opposite sides of the tab of the polyester layer effectively have a tab end 28a of the conductor, the device is adapted for right-or left-handed electrical connection to the circle of gel filled holes with the central hole being visually conspicuously connected to a tab end 22a in the middle. Therefore, the tab ends 22a, 28a cannot be confused if, for example, relative positive and negative connections thereto are desired.

In the third embodiment, the circle of the conductor 32b is wide enough to cover the gel filled holes. Circumferential alignment between portions of the conductor and the gel filled holes is, therefore, not needed. Also, only the tab end 28b of the connected conductor 26b extends onto the tab of the polyester layer.

When the device is adhered on a patient's skin over an acupuncture point, the tabs 22,28 of the first embodiment can be raised from the layer-parallel shipping condition to a projecting, use condition that is vertical (perpendicular to the disc) as shown in Fig. 8 but could be at other projecting use angles in other embodiments (not shown), as suggested in Fig. 7. In the use condition, the tabs can be engaged by electric supply clamps 34 and wire leads of a known stimulator (not shown) to provide electric pulses for a pulsed electric field 36 as shown in Fig.

8 that stimulates an acupuncture point in the electric-field-penetrated patient's body (not shown) below the device. Similar clamps and wire leads (not shown) may engage the tab ends 22a, 22b, 28a, 28b of the second and third embodiments.

Preferably, however, the tabs 22,28 of the first embodiment in the perpendicular raised, use condition shown in Fig. 8 slip between electric contacts 38 in slots 39 (Fig. 12) in a power and/or control unit 40 shown in Figs. 9-12. For this, the power and/or control unit of the device has a base 42 the same diameter as

the disc 10 with a lip 44 about it that is the same or slightly less deep as the disc is thick, whereby the adhesive foam layer 14 can adhere the electrode disc 10 to a patient's skin as described above while the lip and tabs hold the power and/or control unit on the adhered disc.

As shown in Fig. 11, the power and/or control unit 40 has on a surface opposite the base a variety of on/off, frequency, pulse width, intensity and/or like controls known for known stimulators.

As shown in Fig. 12, the power and/or control unit 40 includes a battery 46 for power. The battery is accessible through a battery hatch cover 48 in the base 42 of the power and/or control unit.

However, as shown in Figs. 10 and 12, the power and/or control unit also has a port 50 in its rear elevation of receiving a power jack 52 that can supply power in place of or in addition to the battery. Other embodiments (not shown) may have only one or the other of the battery 46 or port 50 for power.

As thus descried, a self-contained, self-adhesive device is attached to electronic circuitry either directly as in Fig. 10 or through wire leads as in Fig. 8 to provide electrical impulses to a specific acupuncture point under the patient's skin.

The disc has a fixed central gel electrode with an outer circular gel electrode arrangement spaced from the central gel in cun units to assist in location at the acupuncture point.

The foam layer also provides in this case elasticity to assure adequate pressure the central gel electrode with the patient's skin at the acupuncture point while the adhesive secures the rest of the disc to the skin for providing a low resistance circuit with the acupuncture point.

This electrode complex is attached to an impulse stimulator consisting of a power source and electronic circuitry with controls for impulse intensity and frequency. The electronic impulse stimulator allows for a stimulation frequency between about 2 Hz and 500 Hz, a pulse width between about 40 as and 260 as, and a pulse amplitude between about 1 mili-ampere and 50 mili-amperes. It is designed to attach directly to the electrode disc at least in the first embodiment of

Fig. 1.

The disc is applied to the skin over a specific acupuncture point. The distance between the center and outer circular gel electrodes is designed to provide a convenient ruler for proper placement of the device. A single unit can be used alone to provide a therapeutic effect or a combination of several units can be employed for what is often referred to as an energetic therapeutic approach. When in place, the device is activated at the specified frequency as described above. The current is then increased until the pulsation is at an intensity level comfortable for the patient.

Particular features thus are: self contained, self adhesive device providing single non-invasive acupuncture point stimulation; elasticity of electrode disc material that provides for proper pressure of the center electrode at the acupuncture point for a low resistance pathway; circular outer electrode pattern around a central electrode to produce a uniform current field that minimizes loss as well as providing for latitude in placement of the electrode disc; a concentric electrode arrangement that assures proper orientation of the electromagnetic field; the distance between the center electrode and outer circumferential electrode is a"cun" (a term referring to a body unit which is the units used to measure the precise location of the acupuncture point from specific anatomical landmarks) to incorporate a ruler for locating the specific location of the acupuncture point of interest, which may be on the trunk or extremities of the patient's body; and application for needle phobic and pediatric population.

These and other features in equivalence, combination or permutation as may occur to those of ordinary skill in the art are contemplated as within the scope of the following claims.