Patent Description:
Chronic pain is a problem for millions of individuals throughout the world. One method of treating such pain is to provide microcurrent stimulation around or near the areas where the pain is occurring. Microcurrent, which typically is defined as current below one (<NUM>) milliamp, can provide rapid and long-lasting pain relief for a wide variety of pain syndromes. Generally, microcurrent stimulation therapy typically includes applying a current in the range of about <NUM> to about <NUM> microamps (~<NUM> to ~<NUM>µA) to the affected area. The current blocks neuronal transmission of pain signals and stimulates the release of endorphins to help relieve the pain in chronic and acute pain patients and suppress the inflammatory response.

In addition to chronic pain relief, microcurrent therapy is being used to treat a number of visual diseases, including macular degeneration, retinitis pigmentosa, macular edema, glaucoma, optic neuritis, Bell's Palsy and other diseases. It is believed, through secondary literature, that this microcurrent treatment stimulates blood flow, increases ATP (adenosine triphosphate) at the cellular level, and enhances cellular permeability. Further, it is believed such stimulation can re-establish functional neural pathways for muscle and brain, as well as for blood vessel and brain.

Age-related macular degeneration (AMD) is a very common eye disease, affecting more people than glaucoma. Macular degeneration is the most frequent cause of blindness for patients aged <NUM> and above in the United States, and is estimated to affect over <NUM> million Americans. (Source: National Health Institute). Macular degeneration results in the deterioration of various retinal tissues in the region of the macula, the central, most sensitive light-sensing area of the retina responsible for detailed central vision. Impaired blood circulation in the central retina, with partial to full corresponding vision loss, is a typical consequence of macular degeneration.

Because there is currently no approved treatment for dry AMD, little research has been done on the market potential. There is, however, significant data on the large numbers of people affected by AMD, which is estimated to cause about <NUM>% of blindness and low vision globally. According to a report from the World Health Organization, "AMD is the primary cause of blindness in the developed countries and the third leading cause worldwide. " The prevalence of AMD in Europe is estimated to be: <NUM> million people (excluding southeastern and eastern Europe), and in the United States <NUM> million people. Further, this increases to a combined total of <NUM> million cases when adding in Canada, Australia, New Zealand, Russia, and Japan. Ninety percent (<NUM>%) of these cases are dry AMD for which there is no currently approved treatment to restore vision.

Approximately <NUM>% of the population in the target markets (aged <NUM> to <NUM> years old) has AMD, and this increases to <NUM>% for ages <NUM> and older. Within the next <NUM> to <NUM> years, as "baby boomers" reach their mid-sixties and older, the prevalence of the disease is projected to dramatically increase. In a study funded by the U. Centers for Disease Control and Prevention, researchers reported that as many as <NUM> million people in the U. had AMD in <NUM> and <NUM> million would have it by <NUM> (<NPL>).

spends $<NUM> trillion in healthcare each year, of which eye care represents roughly three percent or $<NUM>-$<NUM> billion of the total. According to Eurostat, the European Union (EU) spends <NUM>% of that amount or about $<NUM> trillion. Expenditures for eye care are growing at six percent annually. According to the National Institute for Health (NIH), it is expected to continue to grow at least six percent over the next several decades, driven by the aging population.

Macular degeneration causes about $<NUM> billion in lost productivity each year and approximately $<NUM> billion is spent treating macular degeneration each year in the United States. Ninety percent (<NUM>%) of macular degeneration cases are the "dry" or non-bleeding form, termed "atrophic AMD" and about <NUM>% of cases are the "wet" or bleeding form, termed "exudative AMD".

<CIT> with the title "Method and apparatus for performing microcurrent stimulation (MSC) therapy," describes a method and apparatus for providing microcurrent stimulation (MSC) therapy. Patent <CIT> states: it has been determined that the application of microcurrent signals at particular frequencies to the eye for particular periods of time stabilizes and even improves conditions of macular degeneration and other ocular diseases.

<CIT> with the title "Multi-mode microcurrent stimulus system with safety circuitry and related methods," describes a microcurrent stimulation device with a power supply, two or more electrodes electronically coupled to the power supply, a microcontroller configured to generate an electromagnetic waveform, an impedance measurement module configured to measure electrical impedance of one or more biological tissues between the two or more electrodes. A first safety circuit monitors electric current flow through one or more components of the microcurrent stimulation device and interrupts electric current flow if the electric current flow through the one or more components is above a predetermined level. A second safety circuit interrupts electric current flow through the one or more components if a firmware failure occurs.

<CIT> with the title "Adherent device with multiple physiological sensors," describes an adherent device to monitor a patient for an extended period comprises a breathable tape. The breathable tape comprises a porous material with an adhesive coating to adhere the breathable tape to a skin of the patient. At least one electrode is affixed to the breathable tape and capable of electrically coupling to a skin of the patient. A printed circuit board is connected to the breathable tape to support the printed circuit board with the breathable tape when the tape is adhered to the patient. Electronic components electrically are connected to the printed circuit board and coupled to the at least one electrode to measure physiologic signals of the patient. A breathable cover and/or an electronics housing is disposed over the circuit board and electronic components and connected to at least one of the electronics components, the printed circuit board or the breathable tape.

<CIT> with the title "Nervous tissue stimulation device and method," describes a method using a precisely controlled, computer programmable stimulus for neuroselective tissue stimulation that does not leave a sufficient voltage or electrical artifact on the tissue being stimulated that would interfere or prevent a monitoring system from recording the physiological response is utilized to evaluate the physiological conduction of the tissue being studied. A computer controls both the waveform, duration and intensity of the stimulus. An output trigger to the nerve response recording component controls the timing of its operation. A neuroselective nervous tissue response latency and amplitude may be determined. The computer controlled stimulus may also be administered for therapeutic purposes.

<CIT> with the title "Multiple electrode assembly," describes multiple electrode assemblies that provide an electrical connection between a patient's body and monitoring equipment. A multiple electrode assembly requires only half as many assemblies as a conventional single electrode assembly to attach a patient to multiple pieces of equipment. Less time is required to attach the patient to the monitoring equipment. There is less patient discomfort since fewer assemblies are attached to the patient. The placement of fewer assemblies also leads to a reduced cost. The assemblies can take on a number of different shapes and lead attachment configurations to accommodate a wide range of monitoring functions.

<CIT> with the title "Method and arrangement for determining suitable treatment frequency and/or intensity," describes a method and arrangement for determining a suitable treatment frequency and/or intensity of a treatment signal used in electrical treatment. In the method, a stimulating electrical signal is directed to an object to produce different reaction types in the object at different intensities of the stimulating electrical signal. For at least three different reaction types, the intensity of the stimulating electrical signal at which a reaction type occurred is stored. The electrical signal intensities stored for the different reaction types at least at three different frequencies are compared with reference values and the frequency and/or signal intensity at which the signal intensity deviates sufficiently from one or more reference values is determined. The method utilizes the frequency and/or signal intensity found in the process in determining the suitable treatment frequency and/or signal intensity.

<CIT> with the title "Apparatus and method for determining cardiac output in a living subject," describes an improved apparatus and method for determining the cardiac output of a living subject. Their improved apparatus generally comprises one or more electrode assemblies or patches affixed to the skin of the subject in the vicinity of the thoracic cavity. The terminals of each electrode patch are in contact with an electrolytic gel, and are spaced a predetermined distance from one another within the patch. This predetermined spacing allows for more consistent measurements, and also allows for the detection of a loss of electrical continuity between the terminals of the patch and their associated electrical connectors in the clinical environment. The method generally comprises generating and passing a stimulation current through the terminals and the thoracic cavity of the subject, and measuring the impedance as a function of time. This impedance is used to determine cardiac muscle stroke volume, which is then used in conjunction with the subject's cardiac rate (also detected via the electrode patches) to determine cardiac output. A method of detecting a loss of electrical continuity in one or more of the terminals of the electrode patch is also disclosed.

<CIT> with the title "Methods and apparatus for electrical microcurrent stimulation therapy," describes an apparatus for supplying an electrical signal to a body part in order to provide microcurrent stimulation therapy to the body part. The apparatus preferably comprises a first sweep wave or sweep frequency signal generator configured to generate a first sweep wave signal, a buffer amplifier circuit configured to receive the first sweep wave signal from the first sweep signal generator and amplify and buffer the sweep wave signal creating a buffered sweep wave signal. In addition, the apparatus preferably includes a current limiting circuit configured to receive the buffered sweep wave signal from the buffer amplifier circuit and limit the amount of current supplied to the body part. Finally, the apparatus preferably comprises a probe for applying the sweep wave signal to the body part. The apparatus may further comprise a second signal generator for generating a second signal which may comprise either a sweep wave signal or a non-sweep wave signal. The apparatus also will include a signal combining circuit configured to receive the first and second signals from the first and second signal generators and combine the first and second signals into a composite sweep wave signal.

<CIT> with the title "Methods and apparatus for electrical microcurrent stimulation therapy," describes a method and apparatus for providing microcurrent stimulation therapy to a body part is disclosed. In one embodiment, a method allows digital control of the modulation frequency of the microcurrent signal. The method includes receiving a first digital data word which is used to produce a first frequency related to the first digital data word, whereupon, a first microcurrent signal at the first frequency is applied to the body part. A second digital data word is received and used to produce a second frequency related to the second digital data word. A second microcurrent signal at the second frequency is applied to the body part. In another embodiment, a method allows direct digital synthesis of the microcurrent stimulation signal. A first digital data word is used to produce a first analog voltage which is applied to the body part. A second digital data word is used to produce a second analog voltage which is also applied to the body part, where the first analog voltage is different from the second analog voltage. In yet another embodiment, an apparatus for providing microcurrent stimulation therapy includes a digital-to-analog converter, a controller and a plurality of data words. The controller is coupled to the digital-to-analog converter and supplies the digital-to-analog converter with digital data words in order to generate an electrical signal for the microcurrent stimulation therapy.

<CIT> with the title "Method and apparatus for performing microcurrent stimulation (MSC) therapy," describes a method and apparatus for providing microcurrent stimulation (MSC) therapy, and asserted: it has been determined that the application of microcurrent signals at particular frequencies to the eye for particular periods of time stabilizes and even improves conditions of macular degeneration and other ocular diseases and that experimental data from clinical trials shows that results of persons who underwent therapy are at least better than placebo, and that the therapy is safe and efficacious. Patent Publication <CIT> continued: experimental data from clinical trials showed that approximately <NUM>% of the patients who underwent the MCS therapy of the invention experienced either stabilization or improvement of macular degeneration within one year of starting therapy. Of this percentage, approximately <NUM>% of the patients subjected to the MCS therapy experienced improved vision, while approximately <NUM>% experienced stabilization of macular degeneration (i.e., no further loss of vision).

<CIT> with the title "Method for standardizing spacing between electrodes, and medical tape electrodes," describes Standardization between paired electrodes is maintained in a medical device without needing a Mylar spreader, such as by forming the paired electrodes integrally with a tape part.

<CIT> with the title "Method and apparatus for sleep induction," describes an apparatus and method to induce sleep in a patient that utilizes an oscillator to control the frequency of electric impulses received by the patient. First and second multivibrators generate the signals necessary to stimulate the central nervous system by conduction through the optic nerve tract, and also to generate a visual aura caused by stimulation of the retina of the eye. An amplifier amplifies the signals generated by the multivibrators and electrodes transmit the amplified signal to the patient. The various components of the apparatus may be stored in an eye frame structure wherein eye lid electrode pads are held in place contiguous the eyes of the patient, and wherein mastoid electrode pads are held in place by means of the frame ear hooks.

<CIT> with the title "Apparatus and method for ocular treatment," describes that macular degeneration and other ocular pathology in a subject are treated by the steps of: placing a positive electrode of a direct current source in electrical contact with a closed eyelid of a subject; placing a negative electrode of the source in electrical contact with the posterior neck of the subject; and causing a constant direct current of <NUM>µA to flow between the electrodes through the subject for about <NUM> minutes. The source can be a portable, battery powered constant direct current generator which is affixed to the subject. The subject can ambulate during treatment.

<CIT> with the title "Miniature wireless transcutaneous electrical neuro or muscular-stimulation unit," describes a miniature wireless transcutaneous electrical neuro or muscular stimulation unit. The unit has a housing attached to a plurality of electrodes. An electronics module containing an electrical circuit is contained within the housing and provides a sequence of monophasic or biphasic pulses to a patient's pain site via the electrodes. The electrodes can be disposable and come in a variety of shapes and sizes. The patient may select and control the intensity and the frequency of the pulses by choosing one of several TENS and microcurrent waveforms, as well as the orientation and quantity of the electrodes. The means for supplying power to the electronics module can be integrated with the electrodes in one detachable and disposable assembly. A worn-remote controller can send transmission signals to a receiver within the electronic module thereby allowing the patient to program specific units placed on the patient's body to perform operations in a specified series of waveforms. The electrodes may be embedded in a splint, bandage, brace or cast, where wires or flex-circuit material connect the electrodes to the unit. The electrodes can be arranged in a grid-like manner to allow for programming of a specific firing order which provides for greater therapeutic effect to a pain site, and may also be embedded in adhesive strips, similar to a conventional Band-Aid.

<CIT> shows an electrode apparatus for implanting in an eyelid. <CIT> shows a non-invasive magnetic and/or electric remedy placed near the eye for reducing vision problems caused by floaters (a condition of the vitreous humor in the human eye). <CIT> shows a device for electrostimulation of the eye, comprising a spectacles-like supporting frame which has a nose part and an arrangement, connected to the nose part, for holding the supporting frame on the head of the patient, wherein at least one stimulation electrode is arranged on the nose part. <CIT> shows a system for stimulating facial expressions and facial movements such as eye blinks, wherein an electrode support structure is affixed to the face of the user by an electrically conductive adhesive.

What is still needed is an improved apparatus for treating certain eye problems.

The present invention provides an apparatus according to claim <NUM>. The dependent claims define further features and embodiments.

In some embodiments, the present invention applies microcurrent stimulation therapy to key points around the eye (and/or other body parts) for treatment of diseases such as macular degeneration, retinitis pigmentosa, glaucoma, optic neuritis, optic neuropathy, diabetic retinopathy, macular edema, papilledema, and other eye or nerve related, as well as other diseases, such as Bell's Palsy, requiring localized stimulation on other body parts.

The present invention can be used in a non-claimed method that includes: applying the disposable strip of material to the patient's skin; generating prescribed microcurrent pulses by the microcurrent-stimulation controller; and delivering the microcurrent pulses to each respective electrode of the plurality of electrodes in a temporal sequence.

Although the following detailed description contains many specifics for the purpose of illustration, a person of ordinary skill in the art will appreciate that many variations and alterations to the following details are within the scope of the invention which is defined by the attached claims. Further, in the following detailed description of the preferred embodiments, reference is made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration specific embodiments in which the invention may be practiced. It is understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present as defiend by the appended claims.

The leading digit(s) of reference numbers appearing in the Figures generally corresponds to the Figure number in which that component is first introduced, such that the same reference number is used throughout to refer to an identical component which appears in multiple Figures. Signals and connections may be referred to by the same reference number or label, and the actual meaning will be clear from its use in the context of the description.

Normal retinal cell function is a photochemical reaction converting light energy to an electrical impulse which travels to the brain and vision occurs. With AMD and other visual system diseases, diseased and inflamed retinal cells eventually lose cell function. Adenosine triphosphate (ATP) levels drop, protein synthesis drops, the electrical resistance goes up, and cell membrane electrical potential goes down limiting a cell's ability to move substrates into and out of a cell. The cells, without normal metabolic activity, go temporarily dormant for a time before prior to apoptosis.

It is believed that, when electrical stimulation is provided to the cells before they die, blood vessel permeability is increased, normal cellular electrical potential is reestablished or achieved, the ATP levels increase, protein synthesis will occur again, immature cell regeneration is activated, and normal cell metabolism is restored thereby improving or restoring vision function. In addition, in vitro studies have demonstrated that electrical stimulation appears to have a healing effect on the small blood vessels in the retina, promoting a more efficient delivery of nutrients to the retinal cells and a more efficient elimination of metabolic by-products.

The retinal pigment epithelium (RPE) is the support cell complex for the photosensitive rod and cone cells which make up the light-sensing structure of the retina. The RPE is the first to be affected by circulation impairment. Once affected by poor circulation, the RPE cannot efficiently assist the rods and cones in removing the metabolic and photochemical response by-products, which are essential for cellular function. Yellowish-colored sub-retinal deposits called "drusen" form when extracellular by-products are not carried away by blood circulating through the eye. As a result, the photoreceptor cells in the macula lose access to good blood flow and enter a dormant, toxic state and do not respond to light. If normal retinal cellular metabolism is not restored, the cells die and visual acuity is permanently lost. Thus, it is believed that micro-current stimulation will help rejuvenate the cells in the retina to slow or stop degeneration and in many cases trigger regeneration of retinal cells of the eye due to AMD.

While microcurrent stimulation therapy has been used to treat AMD and other visual system diseases, the methods and apparatus used in the prior art do not appear to maximize the therapeutic effect. Clinical studies have demonstrated that with the proper microcurrent stimulation waveform and therapy procedure, AMD may be slowed or stopped in a large number of people suffering from the disease, and in some patient groups vision can be restored. However, the efficacy of these therapies can be affected by the manual techniques medical professionals use to administer the therapy, or by the inefficient design and function of the medical device. When patients have significant skin impedance, or where there is a poor electrical conductivity, uptake of the stimulation level is limited and this may limit the treatment efficacy.

The present invention includes a disposable adhesive therapy appliance that replaces the need for long manual applications of the microcurrent electrostimulation therapy currently used or being envisioned as used by a clinical professional. Furthermore, the present invention also enables the clinician or physician to deliver stimulation to a particular designated point on the body, as opposed to a broader coverage or blanketed area of the body. Conventional technologies have two major drawbacks. First, when stimulation is delivered with a conventional probe or pointer, the probe or pointer is applied to the patient's skin manually and this takes a large amount of clinician time to administer the stimulation and properly deliver it. Secondly, when conventional gel strip or semi-circle or circles are used in any kind of electrostimulation or microcurrent therapy, the conventional gel strip or semi-circle or circles cover and deliver stimulation affecting a broad part of the human body, usually well in excess of <NUM> millimeters across. These conventional gel strips, semi-circles or circles do not permit the delivery of stimulation to a "pinpointed" area of two-to-fifteen (<NUM>-<NUM>) millimeters diameter. In contrast, the present invention allows for stimulation to a sequence of such "pinpointed" areas, and the present invention can, in certain treatment therapies, be more efficacious due to a greater stimulation level delivered on a smaller surface area, which penetrates more deeply and improves treatment performance.

<FIG> is a schematic front-view diagram of a disposable therapy-appliance strip system <NUM> having four disposable adhesive curved linear therapy strips <NUM> positioned on the upper and lower eyelids of the left and right eyes of a person <NUM>, showing exemplary positions of electrodes <NUM> and connections to treatment-control apparatus <NUM>. In some embodiments, for each disposable adhesive curved linear therapy strips <NUM>, each electrode <NUM> of a plurality of individually activatable electrodes <NUM> is coated with an electrically conductive gel and surrounded by an electrically insulating adhesive, in order that when an electrical signal is applied to a first selected electrode <NUM>, the current goes into the tissue of the patient <NUM> only under that first electrode (and, in some embodiments, one or more other electrodes <NUM>) when the signal from treatment-control apparatus <NUM> is active to the first electrode (and the one or more other electrodes <NUM> if those electrodes are also driven at that time). In some embodiments, the area of tissue under each one of a plurality of electrodes is between about <NUM><NUM> and about <NUM><NUM> (e.g., each electrode having electrical contact to skin in a square of about <NUM> by <NUM> to a square of about <NUM> by <NUM>, or a circle having a diameter of about <NUM> to about <NUM>). In some embodiments, each of a plurality of the electrodes <NUM> in disposable adhesive curved linear therapy strip <NUM> has a skin-contact area of about <NUM><NUM> (e.g., a square of <NUM> by <NUM> or other suitable shape with that area). In some embodiments, each of a plurality of the electrodes <NUM> in disposable adhesive curved linear therapy strip <NUM> has a skin-contact area of about <NUM><NUM> (e.g., a square of <NUM> by <NUM>, or a circle having a diameter of about <NUM>, or other suitable shape with that area). Some other embodiments include a plurality of the electrodes <NUM> in disposable adhesive curved linear therapy strip <NUM> wherein each electrode has a skin-contact area of between about <NUM><NUM> and about <NUM><NUM>, a plurality of the electrodes <NUM> in disposable adhesive curved linear therapy strip <NUM> wherein each electrode has a skin-contact area of about <NUM><NUM>, a plurality of the electrodes <NUM> in disposable adhesive curved linear therapy strip <NUM> wherein each electrode has a skin-contact area of between about <NUM><NUM> and about <NUM><NUM>, a plurality of the electrodes <NUM> in disposable adhesive curved linear therapy strip <NUM> wherein each electrode has a skin-contact area of about <NUM><NUM>, a plurality of the electrodes <NUM> in disposable adhesive curved linear therapy strip <NUM> wherein each electrode has a skin-contact area of between about <NUM><NUM> and about <NUM><NUM>, a plurality of the electrodes <NUM> in disposable adhesive curved linear therapy strip <NUM> wherein each electrode has a skin-contact area of about <NUM><NUM>, and/or a plurality of the electrodes <NUM> in disposable adhesive curved linear therapy strip <NUM> wherein each electrode has a skin-contact area of between about <NUM><NUM> and about <NUM><NUM> (e.g., a square of <NUM> by <NUM> or other suitable shape with that area). In some other embodiments, each of a plurality of the electrodes <NUM> in disposable adhesive curved linear therapy strip <NUM> is substantially circular with a diameter of about <NUM> (a skin-contact area of about <NUM><NUM>), while some other embodiments include a plurality of substantially circular electrodes <NUM> each having a diameter of about <NUM> (a skin-contact area of about <NUM><NUM>), a plurality of substantially circular electrodes <NUM> each having a diameter of about <NUM> (a skin-contact area of about <NUM><NUM>), a plurality of substantially circular electrodes <NUM> each having a diameter of about <NUM> (a skin-contact area of about <NUM><NUM>), a plurality of substantially circular electrodes <NUM> each having a diameter of about <NUM> (a skin-contact area of about <NUM><NUM>), a plurality of substantially circular electrodes <NUM> each having a diameter of about <NUM> (a skin-contact area of about <NUM><NUM>), and/or a plurality of substantially circular electrodes <NUM> each having a diameter of about <NUM> (a skin-contact area of about <NUM><NUM>). In some embodiments, each electrode is no larger than <NUM><NUM> (e.g., each electrode sized as a square about <NUM> by <NUM>, or a circle having a diameter of about <NUM>) and wherein the strip is shaped to be positioned to place electrodes on an upper eyelid and a lower eyelid of a the patient's skin, and wherein each one of the plurality of electrodes is configured to be individually activated at a time for microcurrent stimulation without activation of any other ones of the plurality of electrodes during that time. In some embodiments, each electrode is between about <NUM><NUM> and about <NUM><NUM>. In other embodiments, each electrode is no larger than <NUM><NUM> (e.g., each electrode sized as a square no larger than about <NUM> by <NUM>, or a circle having a diameter of no larger than about <NUM>). In some embodiments, each electrode is between about <NUM><NUM> and about <NUM><NUM>. In other embodiments, each electrode is no larger than <NUM><NUM> (e.g., each electrode sized as a square no larger than about <NUM> by <NUM>, or a circle having a diameter of no larger than about <NUM>).

In some embodiments, each disposable therapy-appliance strip <NUM> includes electrical conductors <NUM> electrically coupled to treatment-control apparatus <NUM>. In some embodiments, treatment-control apparatus <NUM> is located locally (e.g., in a battery operated unit that is carried by person <NUM>, such as in a shirt pocket or head-mounted elastic band), while in other embodiments, treatment-control apparatus <NUM> is attached to or part of a computer-controlled apparatus such as a laptop personal computer, a tablet computer, a desktop computer or the like. Therapy signals from the signal source <NUM> are carried by the connection wire bundle <NUM> to electrodes <NUM>, which deliver the current load to the patient's tissue.

<FIG> is a front view of a system <NUM> showing one eye having two disposable therapy-appliance strips <NUM>, one each positioned on the upper and lower eyelid of a person's eye <NUM>, showing exemplary position of electrodes and connections to a micro-current stimulation controller apparatus <NUM>. In some embodiments, micro-current stimulation controller apparatus <NUM> includes a microprocessor (µP) operated by a battery, and optionally is controlled and/or programmed by a nearby laptop personal computer, a tablet computer, a desktop computer or the like. In some embodiments, each disposable therapy-appliance strip <NUM> includes electrical conductors <NUM> electrically coupled to an electrical connector <NUM> that plugs into or otherwise electrically connects to a corresponding connector <NUM> on controller apparatus <NUM>.

<FIG> is a side cross-section view of a disposable therapy-appliance strip <NUM>. As noted above, in some embodiments, each one of a plurality of individually activatable electrodes <NUM> is coated with an electrically conductive gel and surrounded by an electrically insulating adhesive, in order that when an electrical signal is applied only to a first selected electrode <NUM>, the current goes into the tissue of the patient <NUM> only under that first electrode. In some embodiments, only one selected electrode <NUM> is activated (driven by a pulsed electrical signal) at any one time, and each of a plurality of the electrodes <NUM> is sequentially driven by temporally separated pulses. In some embodiments, two or more of a plurality of the electrodes <NUM> are driven by simultaneous pulses or by pulses that at least partially overlap in time. In some embodiments, each one or a plurality of subsets of the electrodes is tested to determine which are most effective at relieving symptoms and/or which, when driven by pulsed signals, may cause a worsening of symptoms. Based on the empirical results of such testing of subsets of the electrodes, the system (e.g., system <NUM> of <FIG>) selectively activates those set(s) of electrodes <NUM> and the sequences of pulses that have been determined empirically to be effective and avoids activation of those set(s) of electrodes <NUM> and the sequences of pulses that have been determined empirically to worsen symptoms. The connection wire bundle (e.g., a cable having a plurality of electrical conductors) <NUM> is shown leading to the strip substrate <NUM> containing the electrodes <NUM>.

<FIG> is a schematic enlarged cross-section view of a disposable therapy-appliance strip subsystem <NUM> including therapy-appliance strip <NUM> and peel-away cover <NUM>. In some embodiments, disposable therapy-appliance strip <NUM> includes electrodes <NUM> that are equivalent to those in disposable therapy-appliance strip <NUM> described above, however, disposable therapy-appliance strip subsystem <NUM> further includes one or more light emitting features <NUM> (such as light-emitting diodes (LEDs) mounted in or on disposable therapy-appliance strip <NUM>, or light-conducting optical fibers connected to LEDs in micro-current stimulation controller apparatus <NUM> or treatment-control apparatus <NUM> described above) and/or one or more vibration units <NUM>. In some embodiments, light emitting features <NUM> are activated to emit light pulses at the same time that electrical treatment signals are applied to one or more electrodes <NUM> to provide feedback to patient <NUM> and/or to the medical care professional who is monitoring the procedure, in order to provide to them feedback to indicate that the procedure is in process. In some embodiments, vibration units <NUM> are activated to gently vibrate the eyelids of patient <NUM> at the same time that electrical treatment signals are applied to one or more electrodes <NUM> to provide feedback to patient <NUM>, in order to provide to them feedback to indicate that the procedure is in process. In some embodiments, therapy-appliance strip subsystem <NUM> includes the optional addition of one or more motors <NUM> and/or one or more LEDs <NUM> for feedback. In some embodiments, the LED(s) provide a visually perceivable indication of the functioning operation of therapy strip <NUM> as feedback to patient <NUM> and/or to the medical professional supervising the treatment that the device is functioning and/or an indication of which therapy protocol (e.g., one of a plurality of selectable protocols) is being applied and/or an indication of how much time is remaining in the present session (or how much time has elapsed since the start of the present session). In some embodiments, the one or more motors <NUM> drive an off-balance shaft that provides a tactile vibration to the patient's eyelid). In some embodiments, the light emitter(s) <NUM> on the strip indicates, via a single light or multiple lights, what the apparatus status is: off, in-treatment, intermittent connections, inappropriate electrical impedance, and/or insufficient stimulation, and/or progress status of therapy (e.g., whether the session is <NUM>/<NUM>, <NUM>/<NUM>, <NUM>/<NUM>, or <NUM>/<NUM> finished). In some embodiments, the light from LED(s) <NUM> is made to be visible through the patient's closed eyes to indicate that the therapy session is "in treatment and working," or whether the session is finished. In some embodiments, the light emission from LED(s) <NUM> is also visible externally so that the clinician can assess the status of the treatment therapy in session on a patient-by-patient basis without referring to a display screen on base station <NUM>. In some embodiments, the application of an amount of microcurrent into one of the electrodes (e.g., in some embodiments, about <NUM> microamps or more may cause some patients to perceive a microcurrent-caused flash of light and/or a sensation of vibration) from the microcurrent applied into and around the eye, even in the absence of LED light emission from LEDs <NUM>, and thus the emission of light from the LED(s) <NUM>, and/or the vibration from motors <NUM>, can be used to mask from the patient whether or not microcurrent pulses were applied through one of the electrodes <NUM>. For the purposes of testing the efficacy (wherein efficacy can be defined as the performance of a therapy under ideal and controlled circumstances) and/or effectiveness (wherein effectiveness refers to the therapy's performance under "real-world" conditions) of the pulsed microcurrent therapy, it can be useful to supply a subset of patients with actual therapy along with light from the LED(s) <NUM>, and/or vibration from motors <NUM> while presenting a different subset of patients with sham or placebo therapy with the difference (between the actual and sham sessions) masked, from the patient as well as from the medical professional supervising the treatment by light from the LED(s) <NUM>, and/or vibration from motors <NUM> (i.e., using double-blind experiments). In some embodiments, the conductive gel <NUM> on each electrode <NUM> is kept moist and separated from the gel <NUM> on other electrodes <NUM> by cover <NUM> until therapy-appliance strip <NUM> is prepared for use by removing cover <NUM>, thus exposing the gel <NUM>.

<FIG> is a schematic enlarged cross-section view of a disposable therapy strip <NUM>, (i.e., disposable therapy-appliance strip subsystem <NUM> with the peel-away cover <NUM> having been removed) connected to a micro-current stimulation controller apparatus <NUM> to form therapy system <NUM>. This therapy system <NUM>, in contrast to just therapy-appliance strip <NUM> of therapy-appliance strip subsystem <NUM>, includes the addition of the micro-current stimulation controller apparatus <NUM> connected by signal cable <NUM>, wherein controller <NUM> drives the light signal <NUM>, which goes toward the operator, and light signal <NUM>, which goes toward the patient <NUM> (e.g., in some embodiments, through the patient's eyelid).

<FIG> is a schematic enlarged front view of a disposable therapy system <NUM>. As noted above, one or more light emitting features <NUM> and/or one or more vibration units <NUM> are provided in each disposable therapy-appliance strip <NUM>. In some embodiments, one LED <NUM> is provided for each electrode <NUM> and each LED <NUM> is activated at the same time as the corresponding electrode <NUM>. In some embodiments, each LED <NUM> is located adjacent to, or directly above or below, the corresponding electrode <NUM>. This view of the device <NUM> also shows the connector <NUM> for the wire bundle <NUM>.

<FIG> is a schematic enlarged cross-section view of a disposable therapy-appliance strip subsystem <NUM> including therapy-appliance strip <NUM>. In some embodiments, disposable therapy-appliance strip subsystem <NUM> is a single-use product that includes a built-in microprocessor-and-battery unit <NUM> in the disposable therapy-appliance strip subsystem <NUM>. In some embodiments, the battery in unit <NUM> is air-activated via vent <NUM> and removal of the protective air-barrier peel-away cover <NUM> activates the battery by letting air into vent <NUM>. In some embodiments, an auxiliary disposable therapy-appliance strip <NUM> (i.e., a strip without the built-in microprocessor-and-battery unit <NUM> that is applied to one eyelid) can be connected to an activated disposable therapy-appliance strip <NUM> attached to the other eyelid such that the single microprocessor-and-battery unit <NUM> controls operation (sends treatment signals to, and receives feedback signals from, the electrodes <NUM>, LEDs <NUM>, and/or vibration units <NUM>) in both disposable therapy-appliance strip <NUM> and the connected disposable therapy-appliance strip <NUM>. In some embodiments, the micro-current stimulation controller apparatus <NUM> is attached to (and is part of) the strip <NUM>, with an air vent <NUM> that passes through substrate <NUM> to allow air to contact and activate the battery in controller apparatus <NUM>. In some embodiments, controller apparatus <NUM> is actively controlled wirelessly, during operation (e.g., using protocol and circuitry such as Bluetooth®, near-field communications (NFC), or the like) from a nearby computer (such as a tablet, desktop or laptop), while in other embodiments, controller apparatus <NUM> is similarly wirelessly programmed before operation, and thereafter operates autonomously based on the program. In some such embodiments, controller apparatus <NUM> transmits, back to the nearby computer, sensed signals that are then used to determine therapy efficaciousness and/or to control the therapy stimulation signals. In some embodiments, the sensed signals transmitted to the nearby computer include sensed electrical impedance measurements for safety monitoring and control, and/or sensed nerve electrical signals, sensed from the patient's skin, that might indicate patient discomfort or pain and that are then used to limit the stimulation signals that would cause such a reaction in the patient. In some embodiments, one or more of the electrodes <NUM> that are not at the time being used to deliver therapy stimulation signals are instead used to sense nerve electrical signals from the patient's eyelid, and to deliver the sensed signals to an attached controller apparatus.

<FIG> is a schematic front-view diagram of a disposable appliance partially encircling eye strip system <NUM>, using, on each eye, a single partially encircling eye strip <NUM> with electrodes for both upper and lower eye lid showing position of electrodes <NUM> and cable <NUM> to a micro-current stimulation controller apparatus (not shown here - see <FIG> for an example). In some embodiments, a single partially encircling eye strip <NUM> is functionally the same as a pair of curved linear therapy strip <NUM> as described for <FIG>, however single partially encircling eye strip <NUM> provides the advantage that the upper-lid portion and the lower-lid portion are automatically aligned relative to one another, and the connections to the current stimulation controller apparatus is simpler. The various reference numbers in <FIG> are as described above for <FIG>.

<FIG> is an enhanced detail view on eye of disposable appliance partially encircling eye strip <NUM> positioned on the upper and lower eyelid showing position of electrodes and connections to micro-current stimulation controller apparatus. In some embodiments, the single connector <NUM> shown here replaces the two connectors <NUM> of <FIG>. The other various reference numbers in <FIG> are as described above for <FIG>.

<FIG> is a side cross-section view of a disposable partially encircling therapy-appliance strip <NUM>, including a micro-current stimulation controller apparatus <NUM> on the strip <NUM>. The other various reference numbers in <FIG> are as described above for <FIG>.

<FIG> is a schematic front-view diagram of two single encircling strip disposable therapy strips <NUM> forming a system <NUM>. In some embodiments, each of the disposable therapy strips <NUM> is functionally the same as a pair of curved linear therapy strip <NUM> as described for <FIG>, or a single partially encircling eye strip <NUM>, but each of the disposable therapy strips <NUM> provides the advantage that the upper-lid portion and the lower-lid portion are automatically aligned relative to one another at both ends. The various reference numbers in <FIG> are as described above for <FIG>.

<FIG> is an enhanced detail view on eye of disposable eye-encircling therapy strip <NUM> positioned on the upper and lower eye lid showing position of electrodes and connections to micro-current stimulation controller apparatus. In some embodiments, the single connector <NUM> shown here replaces the two connectors <NUM> of <FIG>. The other various reference numbers in <FIG> are as described above for <FIG>.

<FIG> is a side cross-section view of a disposable therapy strip <NUM>, including a micro-current stimulation controller apparatus <NUM> included on the strip <NUM>. The other various reference numbers in <FIG> are as described above for <FIG>.

<FIG> is a schematic back-side-view diagram of an electrode-containing eye-glass-frame <NUM> having two encircling frame members <NUM> each having a plurality of electrodes <NUM> positioned on strips on the periphery of each frame member <NUM>. In some embodiments, eye-glass-frame <NUM> includes mechanical connectors <NUM> and <NUM> on the temple tips of elastic side members <NUM> that provide an adjustable-length holding mechanism to snugly hold frame members <NUM> against the orbital bone and/or eyelids of the patient, and a stretchy (elastic) bridge <NUM> that provides an adjustable inter-ocular distance between the left and right eye of the patient. In some embodiments, each one of a plurality of conductors in cable <NUM> is electrically connected to a corresponding one of the plurality of electrodes <NUM>. In some embodiments, each encircling frame member <NUM> differs from the single encircling strip disposable therapy strips <NUM> in that no adhesive is used to hold the electrodes against the eyelids of the patient; rather, the elastic side members <NUM> wrap around the head of the patient to snugly hold the electrodes <NUM> against the skin of the patient around the patient's eyes. The absence of adhesive is an advantage in removing the electrodes from the patient as compared to, for example, removing two single encircling strip disposable therapy strips <NUM> of a system <NUM>. The absence of adhesive is also an advantage for patients who may be allergic or sensitive to the adhesive. The other various reference numbers in <FIG> are as described above for <FIG>.

<FIG> is a schematic back-side-view diagram of an electrode-containing eye-goggle-frame <NUM> having two face-conforming eye-encircling strips <NUM>.

<FIG> is a schematic top-side-view diagram of eye-goggle-frame <NUM> having two face-conforming encircling strips <NUM>. In some embodiments, eye-goggle-frame <NUM> includes a stiff two-part frame member <NUM> having an elastic bridge connector <NUM> flexibly and stretchily holding the two parts to one another while providing the stretch capability to vary the distance between to match the eyes of the patient. In some embodiments, each face-conforming eye-encircling strip <NUM> is positioned on a flexible compressible elastic extension <NUM> that extends backward (toward the patient's face) from a corresponding base <NUM> that is attached to the two-part frame member <NUM>. The flexible compressible elastic extension <NUM> allows each eye-encircling strip <NUM> to better conform to the patient's face. In some embodiments, a cable <NUM> (connecting to, or extending as, electrical wiring within electrode-containing eye-goggle-frame <NUM> to connect to the electrodes <NUM>) extends from one side or both sides of two-part frame member <NUM>, and conducts electrical stimulation and/or sensing signals between an external controller (not shown here) and the electrodes <NUM>. In some embodiments, each eye-encircling strip <NUM> is more flexible than encircling frame member <NUM>, and again differs from the single encircling strip disposable therapy strips <NUM> in that no adhesive is used to hold the electrodes against the eyelids of the patient; rather, the elastic side members <NUM> wrap around the head of the patient to snugly hold the electrodes <NUM> against the skin of the patient around the patient's eyes. The other various reference numbers in <FIG> are as described above for <FIG>.

<FIG> is a schematic exploded top-side-view diagram of an eye-goggle-frame <NUM> having two yet-to-be-attached disposable adhesive eye-encircling strips <NUM>. In some embodiments, the adhesive on the removable and replaceable eye-encircling strips <NUM> is on the frame side (not on the side that touches the patient's face) and adheres eye-encircling strips <NUM> to surface <NUM> on the elastic cups <NUM>. In some embodiments, electrical connectors <NUM> on the strips <NUM> electrically connect to matching cup-side connectors <NUM> on surface <NUM> of the flexible compressible elastic extension <NUM>. As with the device of <FIG>, in some embodiments, eye-goggle-frame <NUM> includes a stiff two-part frame member <NUM> having an elastic bridge connector <NUM> flexibly and stretchily holding the two parts of frame member <NUM> to one another while providing the stretch capability to vary the eye-to-eye distance between the two parts to match the eyes of the patient. In other embodiments, frame <NUM> is a single stiff piece (omitting elastic bridge connector <NUM>) and the flexible compressible elastic extensions <NUM> provide the lateral eye-to-eye distance compensation. In some embodiments, each face-conforming eye-encircling strip-receiving surface <NUM> is positioned on a flexible compressible elastic extension <NUM> that extends backward (toward the patient's face) from a corresponding base <NUM> that is attached to the frame member <NUM>. The flexible compressible elastic extension <NUM> allows each eye-encircling strip <NUM> (which is adhered to flexible surface <NUM>) to better conform to the patient's face. In some embodiments, each eye-encircling strip <NUM> includes a double-sided pressure-sensitive-adhesive-coated foam layer <NUM>, adhered on one of its faces to a hypo-allergenic substrate <NUM> on which are deposited a plurality of electrodes <NUM> each individually electrically connected by a conductor (also deposited on substrate <NUM>) to a separate corresponding contact on electrical connector <NUM>. In some embodiments, a first peel-away protective layer on the frame side of double-sided pressure-sensitive-adhesive-coated foam layer <NUM> is removed so that eye-encircling strip <NUM> can be stuck (adhered) to strip-receiving surface <NUM>. In some embodiments, a small glob of electrically conductive gel is deposited on each electrode <NUM>, and a second peel-away adhesive-coated protective layer is provided on the patient-skin side of eye-encircling strip <NUM> that covers electrodes <NUM> and the gel, wherein the second peel-away protective layer keeps each glob of gel on its corresponding electrode <NUM> and separated from neighboring electrodes until the second peel-away protective layer is removed immediately prior to use. In some embodiments, a vibration motor such as vibrator <NUM> of <FIG> is incorporated in disposable strip <NUM>. In some embodiments, one or more LEDs <NUM> (such as those of <FIG>) are incorporated in disposable strip <NUM>. In some embodiments, a vibration motor such as vibrator <NUM> of <FIG> is instead incorporated in eye-goggle-frame <NUM> rather than being part of the disposable strip <NUM>. In some embodiments, one or more LEDs <NUM> (such as those of <FIG>) are instead incorporated in eye-goggle-frame <NUM> rather than being part of the disposable strip <NUM>.

In some embodiments, a controller <NUM> (e.g., a microprocessor (optionally including an RF (radio-frequency) transceiver that communicates with a remote PC (personal computer), tablet, laptop or the like) and battery) is mounted to, or is built-in and part of, one side or both sides of two-part frame member <NUM>, and conducts electrical stimulation and/or sensing signals between an external controller (not shown here) and the electrodes <NUM>. In some embodiments, each eye-encircling strip <NUM> and its mounting surface <NUM> is more flexible than encircling frame member <NUM> of <FIG>, and again differs from the single encircling strip disposable therapy strips <NUM> in that no adhesive is used to hold the electrodes against the eyelids of the patient; rather, in some embodiments, an elastic band (not shown here, but similar to band <NUM> of <FIG>) wraps around the head of the patient to snugly hold the electrodes <NUM> against the skin of the patient around the patient's eyes (e.g., on the upper and lower eyelids, and/or on the supraorbital bone (the supraorbital foramen of the frontal bone of the skull) and/or infraorbital bone (the front of the zygomatic bone and/or maxilla)).

<FIG> is a schematic assembled top-side-view diagram of an assembled eye-goggle-frame <NUM> having two disposable adhesive eye encircling strips <NUM>. In some embodiments, the two disposable adhesive eye encircling strips <NUM> are removably adhered to the mounting surfaces <NUM> of eye-goggle-frame <NUM> and the electrical contacts <NUM> and <NUM> are connected to one another. Note that reference number <NUM> refers to each eye-encircling strip <NUM> after it is adhered to and electrically connected to eye-goggle-frame <NUM>, and reference number <NUM> refers to the combination of eye-goggle-frame <NUM> after the two eye-encircling strips <NUM> are adhered to and electrically connected to eye-goggle-frame <NUM>. In some embodiments, a small amount of electrically conductive gel is deposited on each electrode <NUM>. In some embodiments, a through-hole opening all the way through eye-goggle-frame <NUM> is left in front of each of the patient's eyes (wherein one of the adhesive eye encircling strips <NUM> surrounds each of these through-hole openings) such that the patient can see the surrounding environment during the therapy session, in order to reduce claustrophobia, fear or other stress conditions for the patient. In other embodiments, a translucent or opaque covering is provided in order the encourage the patient to minimize eye movement so that the sequence of therapy stimulation pulses continue to stimulate the desired tissue volumes throughout the therapy session. In some embodiments, one or both of adhesive eye encircling strips <NUM> further include one or more LEDs (such as, for example, LEDs <NUM> of <FIG>) that provide the optical indicator function described above, and/or one or more vibration units (such as, for example, vibration units <NUM> of <FIG>) that provide the tactile-feedback function described above. The other various reference numbers in <FIG> are as described above for <FIG>.

<FIG> is a schematic front-view diagram of a system <NUM> that includes two single semi-encircling disposable therapy strips <NUM> that together with controller <NUM> and its elastic head strap <NUM> forming a system <NUM>.

In some embodiments, system <NUM> includes one or more electrodes <NUM>, which are placed in contact with skin on the neck of patient <NUM>, and attached to the main device (controller <NUM>) by conductor (e.g., in some embodiments, wire) <NUM>. In some embodiments, a nose-pad and pad-arm unit <NUM> is provided to support the controller <NUM> on the forehead of patient <NUM> over the patient's eyes <NUM>. In some embodiments, the therapeutic electrical-stimulation pulses are applied in a sequence (one at a time) to the electrodes <NUM> on therapy strips <NUM> surrounding each eye, wherein the return path (i.e., the ground signal) is provided through electrodes <NUM> (in some embodiments, one or more electrodes <NUM> is adhesively a coupled to the neck of patient <NUM>; e.g., one to each side of the neck as shown). In some embodiments, uniphasic signals are applied to the eye electrodes (either all positive voltages relative to ground electrode(s) <NUM>, or all negative relative to ground electrode(s) <NUM>) in order to accumulate the desired ionic molecules in or near the retinas of the patient). In other embodiments, balanced biphasic signals are applied to the eye electrodes (alternating with some positive voltages and some negative voltages relative to ground electrode(s) <NUM>, or by applying differential signals to selected pairs of electrodes <NUM> without using a ground signal to ground electrode(s) <NUM>, and in some such embodiments, ground electrode(s) <NUM> are omitted) in order to prevent accumulation of undesired ionic molecules in or near the retinas of the patient). In other embodiments, uniphasic or biphasic signals are applied between pairs of electrodes <NUM> wherein the current is applied between one electrode <NUM> near one eye (on, say, the left-hand disposable therapy strip <NUM>) and one electrode <NUM> near the other eye (on, say, the right-hand disposable therapy strip <NUM>). In other embodiments, uniphasic or biphasic signals are applied between pairs of electrodes <NUM> wherein the current is applied between one electrode <NUM> and another electrode <NUM> on the same disposable therapy strip <NUM>.

<FIG> is a plan-view diagram of a disposable set <NUM> of electrodes including a single semi-encircling strip disposable therapy strip <NUM> and a single "ground" electrode <NUM>. In some embodiments, two such sets <NUM> of electrodes are adhered to the patient <NUM> in the desired positions; then a controller unit <NUM> (e.g., mounted to a headband such as shown in <FIG>, or mounted to eyeglasses (such as in <FIG>, or mounted to a neck-mounted or other suitably positioned controller)) worn by patient <NUM> is electrically (and/or optically, in the case where optical fibers couple light from LEDs in the controller unit to emission points on therapy strip <NUM>) connected to each unit of the sets <NUM> of electrodes. In some embodiments, electrode <NUM> is connected to the device by conductor cable <NUM>. Some embodiments include a tab or connector unit located between parts of the controller <NUM> to allow for modular assembly and replacement of parts of the device.

<FIG> is a schematic block diagram of a therapy system <NUM> including a controller <NUM> and electrodes <NUM>. In some embodiments, therapy system <NUM> includes base station <NUM>, controller <NUM>, FLASH drive <NUM>, disposable electrodes <NUM>, and (as needed) disposable ground patches, conductive gel and cleaning wipes. In some embodiments, base station <NUM> is a device, such as a laptop personal computer (PC), tablet computer, desktop computer or the like, for selecting parameters, monitoring performance, data collection and storage and communication with the control unit (controller <NUM>). In some embodiments, controller <NUM> is a control unit that contains the electronics that deliver current to the electrode contacts on the eye. In some embodiments, the electrode contacts are part of a disposable strip, goggles or an individual probe or the like. In some embodiments, FLASH drive <NUM> is a USB "thumb drive" that includes encrypted data and program code to provide a fixed number of prepaid patient therapies, wherein each time a successful therapy is completed one therapy unit is deducted from the flash drive. In some embodiments, FLASH drive <NUM> is a USB "thumb drive" that includes encrypted data and program code to provide prescriptions for specific patient therapies, wherein each time a successful therapy is completed one therapy unit is deducted from the flash drive. In some embodiments, once all available therapy unit sessions are completed, the FLASH drive <NUM> can be discarded and a new prepaid flash drive is used. In other embodiments, the FLASH drive <NUM> is also used to gather and record session data and parameters that can be later analyzed to determine long-term effectiveness of various different therapy variations, so once all available therapy unit sessions are completed, the FLASH drive <NUM> is returned to the analysis facility and in exchange for the data and a per-therapy-session fee, a new prepaid flash drive is sent out to the treatment facility. In some embodiments, the patient identification data is anonymized and encrypted for patient privacy and/or legal requirements, while keeping each session with enough information to analyze what works and what does not work. In some embodiments, disposable electrodes <NUM> include a plurality of electrode contacts in the form of an adhesive strip, disposable handheld probe tip or goggle, that includes, for example, six to twelve contacts (or other suitable number), split with some on the upper eyelid portion and others on the lower eyelid portion. In some embodiments, a kit is provided wherein, in addition to the above-mentioned disposable electrodes <NUM> (contact strips), one or more handheld probe tips, and/or goggles and the flash drive, the kit also includes such items as disposable ground patches, conductive gel and cleaning wipes.

In some embodiments, controller <NUM> includes a microprocessor <NUM>, a power system (such as a battery, ultra-capacitor or the like) <NUM> that supplies electrical power to the rest of the controller <NUM>, a current-source <NUM> that is controlled by microprocessor <NUM> based on signals from current and impedance sensor <NUM>, an electrode sequencer <NUM> that selects, for example, which one of six possible electrodes to which to send the electrical pulse signal at any moment in time, as controlled by microprocessor <NUM>, and these pulses are sent through electrode connector <NUM> to the set of electrodes <NUM>. In some embodiments, the set of disposable electrodes <NUM> also includes one or more LEDs (e.g., such as <NUM> of <FIG>) embedded in or on the strip, wherein these LEDs are driven by electrical signals sent through connector <NUM> and provide a status and patient-feedback function to tell the medical-professional person and/or the patient that the system is functioning and active. In other embodiments, one or more status LEDs <NUM> are located in the controller <NUM> and emit light to indicate status directly from controller <NUM>, and/or through optical fibers <NUM> or the like embedded in or on the strip to emission points on the electrode strip, wherein these LEDs <NUM> are driven by electrical signals from microprocessor <NUM> and, as described above, provide a status and patient-feedback function to tell the medical-professional person and/or the patient that the system is functioning and active. In some embodiments, a wireless communications device <NUM> (such as Bluetooth®, NFC, infrared optical communications, or the like) provides one-way or two-way communications to a base station <NUM>. In some embodiments, base station <NUM>, based on a prepaid therapy authorization from, e.g., FLASH drive <NUM>, transmits <NUM> programming information specific for the particular patient, wherein the authorization optionally includes authorization based on a fee having been paid, as well as patient-specific therapy control information that has been customized for the particular identified patient to be treated this session based on a treatment regimen prescribed by an eye doctor or the like. In some embodiments, session parameters are communicated <NUM> back to the base station (with parameters such as the actual number, polarity, sequence and strength of pulses, the measured impedance and/or current, indicated patient discomfort, and the like). In some embodiments, system <NUM> includes a patient-activatable switch (e.g., on system <NUM> or via a separate handheld switch that is wirelessly or in wired communication with system <NUM>) that the patient is instructed to press if and when the patient feels discomfort or concern, and upon activation of that switch, electrical output from system <NUM> or even the entire system <NUM> is immediately shut off, and/or the timing of the activation of the switch by the patient is recorded and transmitted in the communication <NUM> of parameters from the session. Thus, this feedback from the patient herself or himself, in some embodiments, is used to fully shut down the device (for patient comfort and peace-of-mind, as well as a further enhancement to patient safety just in case the current source <NUM> has a fault and is sending too much current), and is then correlated to a particular time or other aspect of the treatment to allow design of better therapy sessions in the future, and/or can be used to immediately terminate the session (wherein microcontroller <NUM> will immediately change all connections to "OFF" (or high impedance) to block any further current to the patient, and/or the entire system <NUM> is then (i.e., after storing the timestamp of the switch press by the patient) shut down and disconnected from power source (e.g., battery) <NUM>. In some embodiments, system <NUM> and/or base station <NUM> include an audio-output unit <NUM> that provides a sound (beep, chime, ding, or the like) associated with therapy session status, to indicate, e.g., "ON/session starting," in therapy, an alert as to insufficient or inappropriate treatment, and "OFF/session ending.

In some embodiments, system <NUM> is a software-driven system that provides programmability of all parameters including frequency, waveform, current level, duration of therapy and number of "cycles" around the eye (wherein, in some embodiments, one cycle is the independent activation of each of the six to twelve electrode contacts). In some embodiments, these parameters are programmed during manufacturing, while in other embodiments, the parameters are programmed in the field by the clinician or a company representative. In some embodiments, modifications to the programming parameters and/or software (e.g., as customized by the prescription for the treatment protocol provided by a licensed medical professional for a specific identified patient) are stored in a plug-in storage device <NUM> (such as a USB FLASH storage device or the like) and the parameters and/or program and loaded (by plugging-in device <NUM>) into base station <NUM> (and then transmitted <NUM> (e.g., wirelessly or by wired connection) to system <NUM> to be stored in the memory of microprocessor <NUM>). In other embodiments, plug-in storage device <NUM> is plugged directly into system <NUM> to load and store the parameters and/or program into the memory of microprocessor <NUM> (in some such embodiments, the base station <NUM> is omitted, while in other embodiments, base station <NUM> is retained to provide the technician/medical professional with status of each session in real time). In some embodiments, base station <NUM> is used to provide the technician/medical professional with status of each session of a plurality of simultaneous patient sessions in real time (e.g., in some embodiments, a laptop computer used as base station <NUM> is programmed to provide a split-screen progress monitor (e.g., wherein the display screen is split into, e.g., quadrants if up to four patients were simultaneously treated) for a plurality of treatment sessions for each of a plurality of patients). In some embodiments, the software may also be modified remotely using the wireless connection to the base station <NUM>. In some embodiments, a prescription for a treatment session (the protocol, parameters and the like for controlling current amount, pulse duration, inter-pulse spacing and how many pulses are to be sent and the like) for each individual patient is prepared and checked by a licensed professional, and this prescription is downloaded and/or stored in base station <NUM>, or into USB device <NUM> along with the prepaid activation code to enable only authorized treatments for specific patients. In some embodiments, the software in base station <NUM> and/or the software in system <NUM> verifies the match between a specific patient's prescription associated with a specific identified patient and patient-identification information of the specific identified patient in order to verify that the correct prescription is used for that patient.

Some embodiments include a large memory in the system <NUM> and/or in the base station to capture and record all pertinent patient and clinic data, including the treatment protocol such as the number of pulses applied to each electrode, the amount of current, and all other relevant parameters of what the treatment session involved (including, for example, whether an actual or sham treatment session was provided to the particular patient). In some embodiments, the recorded data are stored in a permanent-memory portion of USB storage device <NUM> (e.g., using a portion of memory that allows only a single write operation that may be followed by many read operations, in order that the data are permanently stored and later available). In some embodiments, these data are collected remotely and summarized by company and/or clinic personnel. In some embodiments, data is summarized to provide comparisons between patients and clinics and may be used in research. Over time, this data will allow the company or analysis facility to optimize the design and the clinical protocol, thus improving outcomes.

Some embodiments provide greater current-drive capacity via current source <NUM>, as well as better current and impedance measurements via sensor unit <NUM>. This allows the system <NUM> to deliver greater, and more-carefully controlled, current levels that overcome any unexpected higher impedance levels. In some embodiments, apparatus <NUM> has a governor (e.g., current controller) to prevent delivery of more than <NUM> microamps (µA) to the patient during therapy. In some embodiments, base station <NUM> and/or system <NUM> may be activated only via an appropriately encoded message from flash drive <NUM>, or via an authentic encrypted code (e.g., in some embodiments, received from a company website on the internet) that enables the laptop to signal, via WI-FI in some embodiments, the micro stimulation controller <NUM> to conduct the therapy session for a particular identified patient. In some embodiments, the micro stimulation controller <NUM> and system <NUM> is implemented on the goggle (e.g., unit <NUM> in <FIG>), and apparatus <NUM> may be activated via a flash drive <NUM> plugged into system <NUM> or by any other suitable type of connection (such as a USB cable to base station <NUM>).

Some embodiments provide automatic adjustment to changes in impedance. As impedance changes during treatment, from contact to contact and from eye to eye, the control unit <NUM> will automatically adjust to maintain a consistent current level. This improves performance and outcomes. The treatment has been automated to minimize clinician involvement. The system <NUM> automatically manages the therapy to ensure uniform and repeatable results.

In some embodiments, the control unit <NUM> is designed to fit and connect nicely on the left and right ground patches (e.g., <NUM> of <FIG>). This eliminates the potential of losing signal to the left and right set of contacts due to patient movement during therapy. The small size of the control unit reduces clutter, improves patient comfort, and improves device consistency and compliance.

In some embodiments, the control unit is designed to be tamper proof (both physically and electronically), and to provide encryption on the programming and the sensed parameters to prevent hacking.

In some embodiments, the base station <NUM> communicates with the control unit <NUM> via a wireless connection eliminating the need to tether the patient to the base station. This improves compliance and makes the setup and therapy session easier to manage.

In some embodiments, the base station can communicate with multiple control units at one time reducing the number of base stations required, therefore reducing set-up time and the clinician's time to manage multiple patients.

In some embodiments, multiple levels of protection help ensure that the electrical current delivered to the contacts cannot exceed the programmed current. The design ensures that an unsafe level of current cannot be achieved even if the output was shorted (zero impedance). In some embodiments, the control unit <NUM> is powered by a small direct-current (DC) button cell and is not connected to the base station during therapy, reducing or eliminating the possibility of injury to the patient.

In some embodiments, the low cost of the design allows most or all of the system to be single-use and disposable.

In some embodiments, the base station can communicate with a device such as a goggle device and or strips partially or completely encircling the upper and or lower eyelids, as well as other body parts.

<FIG> is a schematic block diagram of a therapy system <NUM> including a controller <NUM> and a plurality of light sensors <NUM> mounted to an eyeglass frame or goggle-type fixture. The other various reference numbers in <FIG> are as described above for <FIG>. In some embodiments, the plurality of light sensors <NUM> are used to sense the amount and/or direction of the ambient light in the room where the therapy is provided, and these data are recorded during some or all sessions, in order to determine whether or not ambient room light during the session makes any difference to the efficacy or effectiveness of treatment (i.e., this provides one additional parameter that is recorded, just in case the ambient light during the therapy session affects outcome and/or whether the patient feels less anxiety or boredom during therapy under differing ambient light conditions).

In some examples the present disclosure includes combinations of two or more features that are individually and/or collectively shown and described above in <FIG>. One non-limiting example of such a combination is to include one or more vibrators, and/or one or more LEDs and/or one or more electrode contact points in the goggle-type fixture of <FIG>. In some other examples the present disclosure provides subcombinations that include most features of the various embodiments, but omit one or more features that are individually shown and described above in <FIG>.

Some examples of the present disclosure include a disposable therapy appliance that preferably includes a curved linear strip, semi-encircling strip, or encircling strip of material containing a plurality of electrodes for applying the microcurrent therapy, and optionally one or more sensors and/or other transducers. In some embodiments, the linear, semi-encircling, or encircling strip of material is positioned to place electrodes on the upper eye lid and the lower eye lid. In some embodiments, the curved linear, semi-encircling, or encircling strip of material includes a mild adhesive to make the strip adhere to the skin, and/or includes a conductive gel at the electrode contact points. Within or on the linear, semi-encircling, or encircling strip are electrodes spaced at specific points that are wired individually and separately to a controller apparatus that generates the prescribed microcurrent in a sequence to the plurality of electrode points on the material. In some embodiments, the microcurrent-stimulation controller apparatus to which the disposable therapy appliance is connected also contains a software system that is programmed to sequence the therapy to the various electrode points on the material, and to also detect electrical impendence from the patient, and thereby provide feedback to the controller apparatus to automatically adjust the level of microcurrent simulation, in order to deliver the amount of stimulation originally pre-selected for that treatment session by the clinician to achieve improved/optimum therapy.

In some embodiments, the disposable therapy appliance includes one or more "light-delivery" filaments threaded through or LEDs embedded in or on the strip material to convey a low level of light signal, indicating to the patient that the appliance/strip is functioning as intended. This low level of light signal is of a selected intensity and a selected spectrum chosen to penetrate the patient's closed eyelid and be received by those photoreceptor cells functioning in the back of the retina. In some embodiments, the light signal will resemble a dull flash or pulsating light, and may be either a white light or a specially colored light (such as red or green).

In some embodiments, the disposable therapy appliance includes a vibrating filament threaded through the strip or vibrator embedded in or on the strip material or simply connected to the strip, to convey a gentle level of vibration as the microcurrent stimulation therapy is being applied. Again, in some embodiments, this provides the function of conveying to the patient that the stimulation is being delivered for those instances where the electrostimulation of the microcurrent, itself, is simply unfelt by the patient. The benefit of this is that the patient can feel that the system is working, and the patient will then be more willing to sit still and complete the full treatment session, versus a session where the patient has no marker to indicate that anything is happening.

In some embodiments, the disposable therapy appliance is positioned and affixed to the patient by the attending physician or clinician in the clinic. The patient's eyelid is cleaned with sterile solution contained in a wipe or similar material. The clinician, using sterile surgical gloves, then opens the packet containing the disposable therapy appliance(s). In some embodiments, the disposable therapy strips have a crack-open, peel-off backing that is removed just prior to user. In some embodiments, the clinician then applies the strip(s) in the following manner:.

In some embodiments, when the therapy is finished, a beeper sounds, a light turns on or flashes, and/or other indication of completion is provided. The clinician then disconnects the strips from the micro-current stimulation controller apparatus generating the micro-current stimulation. The clinician then gently peels back the strips (from whatever configuration is used). The strips will be disposed of in accordance with company instructions as guided by any government directives. The patient's eye is re-cleansed with a sterile wipe or pad.

Advantages of the new technology of the present invention's micro-current stimulation curved linear strip, semi-encircling strip, or encircling strip include:.

Details in some embodiments of the disposable adhesive appliances include one or more of the following:.

Claim 1:
An apparatus comprising a therapy device (<NUM> or <NUM> or <NUM> or <NUM> or <NUM>) that includes a controller (<NUM>) and a strip substrate (<NUM>) containing a plurality of electrodes (<NUM>), characterized in that:
the strip substrate (<NUM>) containing the plurality of electrodes (<NUM>) forms a disposable therapy appliance, wherein the strip substrate has an adhesive for adhering the strip substrate to the skin of a patient and
the controller (<NUM>) is a microcurrent-stimulation controller that is configured to apply microcurrent stimulation therapy to the patient, wherein each electrode (<NUM>) is no larger than <NUM><NUM>, wherein the strip substrate (<NUM>) is shaped to be positioned to place electrodes (<NUM>) on at least one of an upper eyelid and a lower eyelid of the patient's skin for a treatment session, and wherein the controller (<NUM>) is configured to activate each one of the plurality of electrodes (<NUM>) for microcurrent stimulation such that one or more of the plurality of electrodes (<NUM>) is selectively activated at a time without activation of any other ones of the plurality of electrodes (<NUM>) during that time.