WO2020264263A1

WO2020264263A1 - Systems and interfaces for ocular therapy

Info

Publication number: WO2020264263A1
Application number: PCT/US2020/039776
Authority: WO
Inventors: Paul Rockley; James R. Chiapetta
Original assignee: Biovisics Medical, Inc.
Priority date: 2019-06-27
Filing date: 2020-06-26
Publication date: 2020-12-30

Abstract

Wearable therapy apparatus for delivering electrical therapy in the vicinity of the eye. A contact element on a wire is placed on the conjunctiva of the eye to facilitate delivery of electrical therapy to the vicinity of the eye. Some examples are adapted to place the contact element on the inner or outer canthus. A frame structure having an eyepiece and earpiece may be used or, instead, an earpiece may be used, or a neckpiece, or another wearable stimulator, to carry pulse generating circuitry. Systems for replaceable contact elements and wettable contact elements are described.

Description

SYSTEMS AND INTERFACES FOR OCULAR THERAPY

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of and priority to US Provisional Pat App. No. 62/867,421, filed June 27, 2019, and titled SYSTEMS AND INTERFACES FOR OCULAR THERAPY, the disclosure of which is incorporated herein by reference.

FIELD

The present invention relates generally to the field of delivery of therapeutic energy for treatment of a variety of conditions. More particularly, the present invention is directed to systems and methods adapted to delivery energy to the eye and/or tissue surrounding the eye.

BACKGROUND

Therapy to prevent, stop, slow the progression of, or reverse diseases of the eye is of great interest . As life expectancy extends, more and more of the population is at risk for diseases such as age related macular degeneration (AMD). Meanwhile, smaller populations of patients suffer from a variety of maladies, including Stargardfs disease, diabetic retinopathy, retinitis pigmentosa, and other degenerative conditions that affect the retina of the eye. A wide variety of other vision disorders exist which can lead to partial or total blindness. There is a continuing demand for new, adjunctive, and/or alternative systems and methods to treat such disorders including by preventing, arresting or reversing disease progress, or at least by alleviating ongoing symptoms.

A variety of proposed head worn apparatuses have been disclosed for the delivery of electrical stimulus (sometimes referred to as microcurrent therapy) to the eye. Patches, goggles, and devices resembling glasses have been proposed. However, there remains a continuing demand for improved head worn apparatuses for delivering therapy to persons afflicted with diseases of the eye, as well as other conditions (headaches, sleep disorders, fatigue) that may be treated by delivering therapy to the eye and/or surrounding tissue. OVERVIEW

The present inventors have recognized, among other things, that a problem to be solved is the need for new patient interfeces for delivering energy and/or therapy to the eye and surrounding tissues. One form of energy delivery is electrical therapy which, when applied to the eye may be referred to as“ocular modulation.” Such therapy may be electrocurrent therapy, microeurrent therapy or milhcurrent therapy, without intending to limit the scope of the invention to a particular range of current with such terms. Existing apparatuses and the patent arts show various apparatuses having a variety of drawbacks. Some products require a plurality of wires to be managed by the patient or user, who may need to use the product independently and/or outside of the clinical environment. For users suffering from impaired vision, adding the difficulty of managing numerous wires can lead to frustration and eventual non-use of therapy- products. Some known apparatuses are heavy and bulky, and prevent the user from comfortably relaxing during use. New, lightweight and efficient therapy delivery apparatuses are desired

A first illustrative and non-limiting example takes the form of a wearable therapy apparatus for placement about the eye of a user comprising: a frame wearable on the user's head; and a first electrode coupled to the frame and adapted to deliver current to the user's conjunctiva.

Additionally or alternatively to the first illustrative and non-limiting example, the frame comprises at least a nose rest and an ear rest, and the ear rest is coupled to or comprises a second electrode to be placed on the skin of the user. Additionally or alternatively to the first illustrative and non-limiting example, the nose rest comprises or is coupled to a third electrode for placement on the conjunctiva of the patient. Additionally or alternatively to the first illustrative and non-limiting example, the frame comprises electronics for driving a current or voltage through at least the first electrode.

Additionally or alternatively to the first illustrative and non-limiting example, the frame is coupled to a pulse generator comprising electronics for driving a current through at least the first electrode. Additionally or alternatively to the firs illustrative and non-limiting example, the electronics comprises sensing circuitry and a controller, wherein the controller is configured to deliver therapy by first using the sensing circuitry' to determine whether the first electrode is adequately in contact with the conjunctiva of the user to confirm placement, and if placement is confirmed, to then deliver a therapy output via at least the first electrode. Additionally or alternatively to the first illustrative and non-limiting example, the first electrode is contained within a contact element that is adapted to hold a conducting fluid therein while placed on the conjunctiva of a user, thereby conducting current from the first electrode to the user's conjunctiva. Additionally or alternatively to the first illustrative and non-limiting example, the first electrode is coupled to the frame by a first section of wire that couples to a contact patch which is adapted for securing to the skin of the user near the user^'s eye to hold the first electrode in a desired position.

Additionally or alternatively to the first illustrative and non-limiting example, the apparatus may further comprise a pivoting arm coupling the first electrode to the frame and having a first position and a second position, with the pivoting ami shaped so that, when the user is wearing the frame and tire pivoting arm is in the first position, the contact element contacts the conjuncti va, and when the pivoting arm is m the second position, the contact element does not contact the conjunctiva. Additionally or alternatively the pivoting arm is sbapeable. Additionally or alternatively, the pivoting arm comprises a wire surrounded by a light or heat curable polymer, to facilitate shaping of the pivoting arm for fiting a particular user followed by curing to retain a desired shape for the pivoting arm. Additionally or alternatively, the pivoting arm comprises an electrical switch that opens or closes as the arm is manipulated from the first position to the second position, thereby enabling therapy.

Additionally or alternatively to the first illustrative and non-limiting example, the contact element is replaceable.

Additionally or alternatively to the first illustrative and non-limiting example, the first electrode is replaceable.

Additionally or alternatively to the first illustrative and non-limiting example, the first electrode comprises a bar-shaped element sized for placement at the lateral eanthus.

Additionally or alternatively to the first illustrative and non-limiting example, the first electrode composes a bar-shaped element sized for placement at the medial eanthus.

Additionally or alternatively to the first illustrative and non-limiting example, the first electrode comprises a V-shaped element sized for placement at the lateral eanthus. Additionally or alternatively to the first illustrative and non-limiting example, the first electrode comprises a V-shaped element sized for placement at the medial canthus.

A second illustrative and non-limiting example takes the form of a method of treating an eye condition comprising: placing a frame on the head of a user, the frame having a nose rest and an ear rest connected together, the frame comprising at least one electrode on a pivoting arm thereof; pivoting the arm to bring the at least one electrode into contact the conjunctiva of the user; turd activating a pulse generator electrically connected to the frame and at least one electrode to deliver one or more electrical signals to the patient via the at least one electrode.

Additionally or alternatively to the second illustrative and non-limiting example, pivoting the arm enables the pulse generator, and the pulse generator activates itself after being enabled by determining an impedance between tire at one electrode and a second electrode also placed on the patient.

A third illustrative and non-limiting example takes the form of a method of treating an eye condition comprising: placing a frame on tire head of a user, the frame having a nose rest and an ear rest connected together, the frame comprising at least one electrode on a pivoting ami thereof, wherein the frame comprises or is electrically coupled to a pulse generator adapted for issuing electrical signals to the at least one electrode to treat the eye condition, the pulse generator comprising a sensing circuit coupled to at least a portion of the pivoting arm to sense when the at least one electrode is in a position for deliver}_' of therapy, further wherein the pulse generator is configured to determine whether the at least one electrode is in the position for delivery of therapy and, in response thereto, automatically issue one or more therapy signals; pivoting the arm to bring the at least one electrode into contact the conjunctiva of the user, wherein the position for delivery of therapy is defined by contact of the at least one electrode with the conjunctiva, such that the pivoting step causes tire pulse generator to deliver one or more electrical signals to the user via the at least one electrode

A fourth illustrative and non-limiting example takes the form of a method of operation in a system for treating eye conditions, the system comprising a pulse generator electrically coupled to a frame having a nose rest and an ear rest, the frame adapted for placement of the head of a user, the frame also comprising a pivoting arm having an electrode thereon, the pivoting arm configured to pivot between a first position and a second position, wherein the frame comprises a sensor determining whether the pivoting arm is in the first position or the second position, the first position causing the electrode to contact a user s tissue when the frame is on the head of a user, wherein the pulse generator is electrically coupled to the sensor and the electrode, the method comprising: the pulse generator sensing movement of the pivoting arm into the first position; the pulse generator issuing one or more test signals to the electrode on tire pivoting ami to determine whether contact of the electrode to user tissue meets a therapy delivery requi rement; the pulse generator determining that the therapy delivery requirement is met; and the pulse generator issuing one or more therapy signals to the electrode on the pivoting arm.

Additionally or alternatively to the fourth illustrative and non-limiting example, the electrode on the pivoting arm is a first electrode, the method further comprising placing a second electrode the conjunctiva, inner or outer canthus, or upper or lower eyelid of the user, and a return electrode on the patient, further wherein the test signals are delivered using the first and second electrodes, and the therapy signals are delivered using at least one of the first and second electrodes and the return electrode.

Additionally or alternatively to the fourth illustrative and non-limiting example, the electrode on the pivoting arm is a first electrode, the method further comprising placing a second electrode on the conjunctiva, inner or outer canthus, or upper or lower eyelid of the user, and a return electrode on the patient, further wherein the therapy signals comprise a first set of pulses delivered between the first and second electrodes, and a second set of pulses delivered between at least one of the first and second electrodes and the return electrode

A fifth illustrative and non-limiting example takes the form of a method of fitting a system for treating eye conditions, the system comprising a wearable therapy apparatus for placement about the eye of a user including: a frame wearable on the user’s head; surd an arm carrying a first electrode coupled to the frame, the first electrode adapted to deliver stimulus to tire vicinity of the eye of a user, the arm comprising a selectively adjustable polymer material; the method comprising: placing the frame on the user’s head; shaping the arm to bring the first electrode into contact with a target location for therapy delivery, and setting the polymer material to thereby retain the shape of the arm by the use of one or more of heat, light, or cooling.

Additionally or alternatively to the fifth illustrative and non-limiting example, the target location is the conjunctiva of the user. Additionally or alternatively to the fifth illustrative and non-limiting example, the arm is coupled to the frame by a pivot.

Additionally or alternatively to the fifth illustrative and non-limiting example, the first electrode is replaceable.

Additionally or alternatively to the fifth illustrative and non-limiting example, tire arm is removeable relative to the frame.

A sixth illustrative and non-limiting example takes the form of a combination ophthalmic contact element surd tray, the contact element adapted for use with an electrode, comprising: a contact element having a proximal end and a distal end, at least a portion of the distal end adapted to retain fluid and the proximal end adapted to receive a conducting portion of the electrode; and a tray having one or more wells therein for holding a fluid and the contact element, with a seal placed over one of the wells, wherein the seal prevents remo val of the contact element and leaking of the fluid until the peel- off seal is removed.

Additionally or alternatively to the sixth illustrative and non-limiting example, the contact element distal end is closed to prevent passage of the electrode therethrough and adapted for placement on or against tissue of a user.

Additionally or alternatively to the sixth illustrative and non-limiting example, the contact element proximal end comprises a bore having one or more indentations or ridges placed and adapted to snap fit onto corresponding structures of the electrode.

Additionally or alternatively to the sixth illustrative and non-limiting example, the contact element comprises a collar adapted to sit beneath a seal over one of the wells, and the tray comprise a collar seat adapted to receive the collar at the top of a well.

Additionally or alternatively to the sixth illustrative and non-limiting example, the distal end of the contact element has an outer dimension, and the one or more wells have a lower end and an upper end with a neck therebetween, tire neck having an inner diameter that is less than the outer dimension of the contact element such that in order to remove the contact element from a well, the outer dimension of the contact element must be deformed.

Additionally or alternatively to the sixth illustrative and non-limiting example, the contact element comprises first and second sections separated by a dielectric such that the contact element defines two separately addressable electrical contacts. A seventh illustrative and non-limiting example takes the form of an arm for carrying an electrode for delivery of therapy to the vicinity of the eye of a user, the arm adapted for use in conjunction with a frame adapted to receive the arm in a receptacle thereof, the receptacle having at least one electrical contact, the arm comprising: a distal end configured to removeably receive a contact element for contacting a target location for therapy delivery, including a conductive element for insertion into the contact element; a proximal end configured to mate with the receptacle, the proximal end comprising at least one contact, and an outer profile adapted to be received in the receptacle; and a body extending between the first end and the second end, the body including a conductive element within a selectively adjustable polymer material .

Additionally or alternatively to the seventh illustrative and non-limiting example, the proximal end comprises one of a magnet or a ferrous element or material, wherein the receptacle further comprises a corresponding magnet or ferrous element or material adapted to atract to, and hold in place, the proximal end of the arm.

Additionally or alternatively to the seventh illustrative and non-limiting example, the distal end comprises a hub for abutting against the contact element, the conductive element extending from the hub to a distal tip that remains inside the contact element when the contact element abuts the hub.

Additionally or alternatively to foe seventh illustrative and non-limiting example, the selectively adjustable polymer material is a light or heat curable material.

Another example takes the form of a combination of a frame having an earpiece and a nosepiece and a receptacle having at least one electrical contact and a first attractive element, and an arm as in the seventh illustrative and non-limiting example and the noted alternatives thereto.

An eighth illustrative and non-limiting example takes the form of a wearable therapy apparatus comprising a frame having an earpiece and a nosepiece, with an arm extending from the frame and carrying a first wire having a first contact tip, tire first wire and ami sized and shaped to place the first contact tip into contact with the conjunctiva of a user when the earpiece is in contact with the ear of the user and the nosepiece is in contact with the nose of the user.

Additionally or alternatively to the eighth illustrative and non-limiting example, foe apparatus may further comprise a second wire coupled to the nosepiece having a second contact tip sized and shaped to place foe second contact tip into contact with the conjunctiva of the user when the nosepiece is in contact with the nose of the user. Additionally or alternatively, the second wire comprises a tissue pad adapted to adhere to the skin of the user and placed between the arm and the second contact tip.

Additionally or alternatively to the eighth illustrative and non-limiting example, the first wire comprises a tissue pad adapted to adhere to the skin of the user and placed between the arm surd the first contact tip.

A ninth illustrative and non-limiting example takes the form of a wearable therapy apparatus comprising a frame having an earpiece and a noscpicee, with a wire coupled to the nosepiece having a contact tip sized and shaped to place the second tip into contact with the conjunctiva of the user when the nosepiece is m contact with the nose of the user. Additionally or alternatively to the ninth illustrative and non-limiting example, the wire comprises a tissue pad adapted to adhere to the skin of the user and placed between the nosepiece turd the contact tip.

Additionally or alternatively to the eighth or ninth illustrative and non-limiting examples, the frame carries a pulse generator adapted to deliver therapy outputs to the user via one or more of the contact tips.

Additionally or alternatively to the eighth or ninth illustrative and non-limiting examples, the apparatus may include a return electrode coupled to the caipiece of the frame.

Additionally or alternatively to the eighth or ninth illustrative and non-limiting examples, the apparatus may include a pulse generator contained in a housing and coupled via an electrical connector to the frame.

A tenth illustrative and non-limiting example takes the form of a wearable therapy apparatus comprising a neckpiece coupled to at least a first wire, the first wire comprising a contact tip adapted for placement on the conjunctiva of a user, the first wire further comprising a tissue pad adapted to adhere to the skin of the user to be placed near the eye of the patient to hold the contact tip in a desired position, wherein the neckpiece is also a housing containing a pulse generator for issuing therapy pulses to the user when the contact tip is placed on the con_junctiva. Additionally or alternatively the apparatus may comprise a return electrode coupled to the neckpiece.

An eleventh illustrative and non-limiting example takes the form of a wearable therapy apparatus comprising an earpiece adapted to be worn on the ear of a user and housing a pulse generator for outputting therapy pulses, at least one first wire coupling to a first tissue pad having extending therefrom at least a second wire carrying a first contact tip adapted for placement on a conjunctiva of the user, the tissue pad adapted for placement on the forehead of a user such that the second wire will hold the first contact tip in contact the conjunctiva. Additionally or alternatively to the eleventh illustrative and non-limiting example, the first tissue pad has extending therefrom a third wire earning a second contact tip adapted for placement on the conjunctiva of the user. Additionally or alternatively to the eleventh illustrative and non-limiting example, the first tissue pad comprises an electrode for contacting patient tissue.

Additionally or alternatively to any of the eighth through eleventh illustrative and non-limiting examples, the contact tip comprises a V-shaped element adapted for placement on a canthus of the user.

Additionally or alternatively to any of the eighth through eleventh illustrative and non-limiting examples, the contact tip comprises a bar shaped element adapted for placement on a canthus of the user.

Additionally or alternatively to any of the eighth through eleventh illustrative and non-limiting examples, the contact tip comprises a wettable polymer.

Additionally or alternatively to any of the eighth through eleventh illustrative and non -limiting examples, the contact tip comprises a cellulose material adapted to soak up and at least partly retain a conductive liquid.

Additionally or alternatively to any of the eighth through eleventh illustrative and non-limiting examples, the contact tip comprises a replaceable outer portion and an inner conductive member shaped to insert into and retain the replaceable outer portion, wherein the outer portion is adapted to be weted.

Another illustrative and non-limiting example takes the form of a method comprising placing a wearable therapy apparatus as in any of the eighth through eleventh illustrative and non-limiting examples on a user, including placing one or more contact tips on the conjunctiva of the user, and activating a pulse generator of the wearable therapy apparatus to deliver therapy to the eye of the riser.

This overview is intended to provide an introduction to the subject matter of the present patent application . It ss not intended to provide an exclusive or exhaustive explanation of the invention. Tire detailed description is included to provide further information about the present patent application.

BRIEF DESCRIPTION OF THE DRAWINGS

In tire drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different leter suffixes may represent different instances of similar components. Tire drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

Figure 1 illustrates a DTL electrode used on the eye of a patient;

Figure 2 shows select anatomy of the human eye and face;

Figures 3A-3C show ocular therapy apparatuses in use configurations;

Figures 4A-4D show ocular therapy apparatuses in use configurations;

Figures 5A-5C illustrate various electrodes with fluid retaining structures;

Figure 6 shows a replaceable electrode;

Figures 7A-7F show ocular therapy apparatuses in use configurations;

Figure 8 shows another ocular therapy apparatus in a use configuration;

Figures 9A-9B show an ocular therapy apparatus having a pivoting arm;

Figures IGA- IOC show a replaceable fluid retaining contact on an electrode;

Figures 1 lA-1 ID show a tray and method of replacing a contact on an electrode;

Figures 12A-12B show replaceable arms for eye-stimulation electrodes;

Figures 13-14 illustrate, in block form, methods of treatment; and

Figures 15-17 show electrical topologies.

DETAILED DESCRIPTION

lire present invention is generally directed to systems for delivering stimulus to the eye of a patient or user. Some patients may have a disease of the eye, such as one or more of the follow ing: dry or wet macular degeneration, inherited retinal disease, presbyopia, diabetic retinopathy, glaucoma, retinitis pigmentosa, Stargardfs, CMV- retmitis, Best's disease, macular dystrophy, optic neuritis, ischemic anterior optic neuritis, Usher's syndrome, Leber's congenital amaurosis, cone-rod dystrophy, cone dystrophy, choroideremia and gyrate atrophy, central retinal artery occlusion, central retinal vein occlusion, branch retinal artery occlusion, branch retinal vein occlusion, central serous chorioretinopathy, cystoid macular edema, ocular histoplasmosis, ocular toxoplasmosis, retinopathy of prematurity, amblyopia, strabismus, and nystagmus. Some patients suffer from traumatic injuries (such as optic nerve crush), or from vascular insufficiencies that can also negatively affect vision. Other patients may have different conditions that may be treatable by delivery of therapeutic energy to the eye and tissue near the eye. In addition or alternative to vision disorders, some illustrative conditions may include dry eye, headaches, migraine headaches, sleep disorders, fatigue, difficulty focusing or concentrating, problems with blinking, undesired movements (tics or twitching, for example). In some examples, a preventative therapy may be provided for persons who have not been diagnosed with a condition but who may be predisposed for such conditions, such as for patients with genetic markers, family history, or other medical conditions such as diabetes that increase the risk of vision disorders.

In some examples, new systems and methods for delivering electrical stimulus to a user, may be used as a stand-alone therapy or may be combined with other stimuli or therapy, such as light stimulus and/or the provision of cellular, biological, and/or pharmaceutical agents, for therapeutic or preventive reasons. Some examples are suitable for use in ocular modulation. As used herein,“ocular modulation” includes the application to the eye of an electrical signal, delivered non-invasively, or minimally- invasively, to achieve a therapeutic benefit. Therapeutic benefit may include, for example and without limitation, impi-oving or altering blood flow, upicguiating or downregulating synthesis, degradation, binding, release or activity of proteins, enzymes, DNA, RNA, polysaccharides or other endogenous physiological or pathological biomolecules; and/or upregulating, downregulating, activating, deactivating physiological or pathological biopathways, etc. Ocular modulation may be combined with the administration of pharmaceuticals, exogenously derived biomolecules, cell therapy, or photo-, electro- or magneto-reactive or active particles, such as nanoparticles, before, during or after an electrical signal is applied.

In some examples, the devices and systems disclosed herein are suited for use in conjunction with exogenous and/or endogenous stem cell transplantation therapies. For example, a method may comprise delivery of electrical stimulation before, during, or after stem cell transplantation to improve cell survival, repair and/or replacement. In illustrations, the use of methods and systems disclosed herein may enhance native cell survival, transplanted cell survival, transplanted cell integration, and functional synapse formation and/or axon regeneration. Non-limiting examples of endogenous stem cell types which may be suitable tor transplantation in combination with systems or devices of the present invention include Muller cells, retinal pigment epithelial cells (RPE cells) and ciliary pigmented epithelial cells (CPE). Non-limiting examples of exogenous stem cells suitable for transplantation according to some embodiments of the invention include neural stem cells (NSCs), mesenchymal stem cells (MSCs) derived from bone marrow, adipose tissue or dental pulp and stem cells from the inner cell mass of tire blastocyst and induced pluripotent stem cells (iPSCs). See, for example, “Using Electrical Stimulation to Enhance the Efficacy of Cell Transplantation Therapies for Neurodegenerative Retinal Diseases: Concepts, Challenges, and Future Perspectives^"', Abby Leigh Manthey, et al., Cell Transplantation, Vol. 26, pp 949-965, 2017.

In some examples, combination of therapy systems of the invention with biological or pharmaceutical agents may provide improved efficacy or reduced side effects associated with such biological or pharmaceutical agents when administered alone. Pharmaceutical agents currently used to reduce the growth of new blood vessels in wet AMD include anti-angiogenics such Bevacizumab (Avastin®), Ranibizumab (Lucentis®) and Afiibereept (Eylea®), etc. While the benefit of these agents for mitigating symptoms associated with wet AMD are well-known, these agents also may- have side effects including increased eye pressure, inflammation of the eye and others. A benefit of systems disclosed herein includes modulation of cytokines and other endogenous inflammatory- factors involved in the inflammation process. In some embodiments it is foreseen that administration of anti-angiogenic agents listed above or other pharmaceuticals in combination with electrical therapy applied simultaneously with, before (e g 1, 2, 12, 24, 36, 48 and/or 96 hours before), or after (e.g. 1, 2, 12, 24, 36, 48 and/or 96 hours after), injection of such anti-angiogenics, at stimulation parameters used herein, may beneficially improve the efficacy and/or reduce the likelihood of side effects associated with administration of such agents.

Several different modes of energy delivery can be used including mechanical deliver}- (such as sonic energy, including for example, ultrasound), light-based delivery (such as by the delivery of collimated or non-collimated light of selected wavelengths, for example using a laser, a light emitting diode, etc.), electrical delivery (such as by the deliver}- of an electrical signal), and/or magnetic delivery (such as by generating a magnetic field or fields). In some examples, one mode of therapy delivery is used, while the same or a different mode is used to monitor therapy delivery. One component of several examples is the use of configurations that are adapted to provide enhanced tissue contact, enhanced therapy deliver}_', improved efficiency of energy deliver_}', targeted therapy locations, improved user comfort and/or compliance, and/or reduced likelihood of tissue injury or irritation.

Various features for delivering therapy may be understood by review of, for example and without intending limitation, US Patent 7,251,528 to Harold, US PG Pat. Pub. No. 2020/01012.90, titled SYSTEM AND METHODS FOR CONTROLLED ELECTRICAL MODULATION FOR VISION THERAPY, US Patent App. No. 16/697,689, filed on November 27, 2019, titled HEAD WORN APPARATUSES FOR VISION THERAPY, US Patent App. No 16/844,421 , filed on April 9, 2020, titled SYSTEMS AND INTERFACES FOR OCULAR THERAPY, and US Patent App. No. 16/900,115, filed June 12, 2020, titled WEARABLE; MEDICAL DEVICE, the disclosures of which are incorporated herein by reference as showing waveforms, structures, apparatuses and systems for delivery of ocular modulation.

Electrons tinography (ERG) is a technique for determining how the eye responds to light. ERG may be performed using a DTE electrode (so named for Dawson, Trick and Litzkow, who authored a 1979 article disclosing the electrode and its use for ERG) as shown in Figure 1, which shows a DTE electrode used for ERG in the prior art. The DTE electrode, includes a first adhesive patch 12 and a second adhesive patch 14 with a thread 16 therebetween. The thread 16 is conductiv e such as by including one or more conductive (often metal, such as silver) filaments. A connector wire 18 is coupled to the second adhesive patch 14, which is larger than the first adhesive patch 12 In use, the smaller, first adhesive patch 12 is placed medial of the patient A eye, on the nose, and the thread 16 is draped onto the conjunctiva by having the patient look up while gently pulling the lower eyelid out and away from the eye, thus placing the thread 18 behind the lower eyelid. The larger, second adhesive patch 14 is then placed lateral of tire eye, with care taken to avoid placing the thread 16 under tension. The connector wire 18 is then coupled to a reader, and the patient is exposed to varying or flashing lights. Electrical signals are captured from the thread 16 and charted to observe light response of the eye. A DTL electrode as shown in Figure 1 is generally used in a clinical setting after placement of numbing eye drops, and is used to sense electrical signals rather than to deliver them . Home use of such a device would be quite difficult for most low' vision persons.

Understanding how a DTL electrode is used, by reference to Figure 1, is helpful to an understanding of how electrical signals for therapy purposes can be routed to the eye. It is also helpful to refer to the DTI, electrode usage as a contrast to the present invention.

Figure 2 illustrates the eye of a patient. A nasal or medial edge 32 at the inner canthus, and a temporal or lateral edge 34 at the outer eanthus are marked, as are the inferior edge 36 and superior edge 38 of the eye opening. Hie conjunctiva 40 is the mucous membrane that cov ers the front of the eye and lines the inside of the eyelids. Figure 2 exaggerates the conjunctiva 40, in particular on the superior edge 38. Placement of an electrode on the sclera, cornea 42 or pupil may not be particularly useful for a patient to use at home however, an electrode can be placed on the conjunctiva 40 with relative comfort for the patient. In several examples of the present invention, a wet or dry electrode is used to contact the conjunctiva 40. The nasal bridge and nose 46 define the region medial to the eye, while the supraorbital ridge 44 is also shown. Such surrounding facial features can be useful for fixing a therapy apparatus, such as a patch and therapy electrode, in a desired position relative to the eye.

As used herein, the conjunctiva 40 will generally refer to tire palpebral conjunctiva that cover the back side of the eyelids. The palpebral conjunctiva is shown in an exaggerated form throughout the figures of the present application. Electrodes may also be configured to be placed at the inner and outer canthus, as shown below. Medial canthus placement may Involve placement of an electrode in contact with one or more of the conjunctiva, the plica semilunaris and the lacrimal caruncle.

Figure 3A shows a first illustrative embodiment. Here, the user is wearing a frame 100 having a nose rest 120 and an ear rest 130. A lateral portion 1 10 of the frame 100 extends in a downward direction and has extending therefrom a fi rst electrode 112, which is shown contacting the conjunctiva 102 of the user. In some embodiments, the electrode may be flexible. If desired, a swivel, pivot or spring may be used in addition or instead to bring tire first electrode 112 into contact with the target tissue from a wearable frame . A return electrode is shown at 132 extending from the ear rest 130 In any of the examples herein, unless otherwise expressly excluded, the return electrode may be placed anywhere that is suitable tor use, such as on, in front of, or behind the ear, or on the temple, the mandible, the forehead, the back of tire head, the neck, or on the torso (chest, thorax) or on an extremity (arm, wrist, hand, leg or foot, for example) of the user.

An electronics module 134 may be attached or integrated with the ear rest 130, as shown. In the alternative, the electronics module 134 may be replaced with a remote module 1342 which can be coupled by one or more wires to the frame 100, if desired. Hie electronics module 134 or 134" may be as illustrated in Figures 15-17, such as by having an internal power source, or having an external power source. In an example, the electronics module 134, 134’ may comprise a battery, which may be a primary cell or a rechargeable cell. In smother example, the electronics module may comprise a receiver, such as an antenna, an inductor, an optical sensor, or a mechanical transducer, to receive power from a remote power source wirelessly to be stored in a rechargeable battery or to be used directly on the patient.

In an example, the electronics module 134 or 134^" is configured to provide a therapy output for delivery_' via the first electrode 1 12. The electronics module 134 or 134’ may also be configured to sense or otherwise determine whether the first electrode 112 is in a desired position relative to user tissue for therapy delivery. For example, the electronics module may be a signal or pulse generator adapted to output electrical current or voltage in the form of a test pulse or a therapy pulse, and may be further configured to sense the impedance such an output encounters at the interface of the first electrode to tissue. A measured impedance may be compared to one or more thresholds (such as a low threshold to sense shorting or potential high current problems, and/or a high threshold to sense open circuit or high impedance problems) to determine the desired positioning. When desired positioning is not maintained, the user may be alerted to the issue by having a light or sound output generated, or via a user controller (not showm in Figure 3A; see Figures 15-17).

The first electrode 112 may take the form of a conductive element, such as a wire, coupled to or contained at least partly within a piece of conductive polymer, a cellulose wicking material (such as WeckCel®), a cotton covering, a natural or synthetic felt covering, or a foam material. In some examples, the surrounding or containing material is selected to be lint-free or otherwise preventing dropping or shedding small particles during use, to avoid irritation or other adverse outcome. The first electrode 1 12 preferably has a first portion closer to the lateral portion 1 10 that is relatively more stiff to provide a relatively fixed position from which a second portion of higher flexibility extends to contact tissue, such as the conjunctiva, adjacent the eye. Rather than providing an electrode placed on the dry skin, the implementation here is targeting the wet tissue that the eyelids protect. Preferably the first electrode 112, in whole or in part, is sufficiently flexible to stay in contact with the conjunctiva when the user opens and doses the eyelid.

The first electrode 112 may be described as having a proximal end attached to the lateral portion 110 of frame 100, and a distal end for contacting the conjunctiva. In some examples, the first electrode 112 may have a blunted, rounded, looped or curled back distal tip, to limit tissue irritation. In an example the first electrode 112 has a distal contacting region proximal of the distal tip that would contact tissue. The example shown in Figure 3 A shows only the left eye of a user. A single eye is shown to provide greater clarity with respect to the device relative to that eye. The other, right eye, may also have the same structures, provided in mirror fashion, as that shown. Thus in the example of Figure 3A, another electrode may also be provided on the right eye of the user. In this and ail other examples showing a single eye, the structure shown and method described may simultaneously be present and/or used on the other eye. Still further, rather than simultaneous use, alternating use may be performed, such as by delivery of therapy to one eye, then the other, in alternating fashion. In use, an electrode on one eye may output current that is received by an electrode on the other eye, or an electrode elsewhere on the patient such as on the nose, forehead, or temple, or more distant such as behind the ear or neck or on the torso or a limb. Also in use, two electrodes on one eye may he electrically in common, may be used independent of one another relative to an electrode elsewhere, or may be used m an anode/cathode relationship in which the current is delivered to the conjunctiva of an eye and also sunk from the conjunctiva of the same eye. Each such configuration may be used, and in some examples, it may be useful to combine these configurations into a therapy pattern or regimen.

Though not shown, a clip or retainer may be provided to hold the lateral portion 1 10 of the frame 100 away from the eye until application of the electrode 112 to the conjunctiva is desired. The user can first prepare the electrode 112, then don the frame 100, then release the lateral portion 110 and/or electrode 112 from the clip or retainer and place the electrode 1 12 Similar structure and method of use can apply in each of the following examples having a frame.

Figure 3B shows an alternative configuration. Here, the frame 100 having the nose rest 120 and ear rest 130 and first electrode 112 also includes a second electrode 122 that extends from the nose rest toward the inner canthus, coming into contact with the conjunctiva and/or the plica semilunaris or lacrimal caruncle. A third electrode 132 is also shown associated with the ear rest 130. Tire design of the second electrode 122 may be similar to that of the first electrode 112, described above. The signal or pulse generator circuitry may be provided in any suitable manner, such as illustrated above with respect to Figure 3A.

In this example, stimulus may be provided and/or electrical diagnostics may be obtained using any of multiple electrical vectors between electrodes 112, 122 surd 132. A monopolar signal, as that term is used herein, ma be between one or more of the electrodes at/near the eye (that is. electrodes 112, 122), as a first pole, and a distant electrode 132 which may be elsewhere on the head (such as on the temple, behind the ear or by the other eye), the mandible, the forehead, or on the neck, torso or a limb of the user. A bipolar signal, as that term is used herein, occurs between two electrodes on the same eye, such as between electrodes 112 and 122. Monopolar signals and bipolar signals may be delivered at different amplitude or intensity levels. In an example, which is not intended to be limiting, a monopolar signal may be a monopolar therapy signal, while a bipolar signal may be a bipolar diagnostic signal, such as by delivering a bipolar test signal at low amplitude and/or short pulse width, to determine localized tissue contact characteristics, and a monopolar therapy signal at higher amplitude and/or wider pulse width.

In the example of Figure 3B, as well as in each of the other examples herein, the electrodes 112, 122, 132 may be used m pairs or other combinations to sense various signals or characteristics. For example, a sensing circuit may be coupled to one or more of electrodes 1 12, 122, 132, such as by having a dedicated circuit for each electrode 112, 122, 132 or by having one or more switches in a matrix or multiplexed structure to select electrodes or electrode combinations to use as the positive and negative poles for a sensed circuit. Bipolar sensing may be performed using electrode pairs such as 1 12/122, 112/132, or 122/132, while monopolar sensing may be performed relative to a return electrode placed elsewhere. Sensing may be performed to determine tissue contact characteristics, impedance (which can include both bulk impedance and tissue contact impedance), to sense electrical ou tputs and model or measure field propagation, and/or to sense physiological data or activity, such as by sensing for electrical impulses indicative of phosphene-related neural activity, sensing motion as indicated by myopotentials, sensing impedance changes that suggest movement either in a gross sense or in a more focused manner, such as by detecting localized movement (eyelid or eyeball motion, for example, or for any other desired purpose. While it is not necessary to have such sensing capability within the context of the present invention, it is an option in any example shown herei

Figure 3C shows another alternative configuration. Here, the second electrode 122 is still shown coupling to the inner canthus, while the first electrode has been omitted. The signal or pulse generator circuitry may be provided in any suitable manner, such as illustrated above with respect to Figure 3 A. Figure 4A shows another illustration. Here a frame 200 includes a nose rest 220 and an ear rest 230. A remote electrode 232 may connect to the ear rest 230 for placement on the head, neck, forehead, mandible, temple, torso, limb or extremity of the patient. At a lateral portion, an electrode is provided near the outer canthus by- having a contact patch 210, which may be for example a gel patch or adhesive patch configured to attach to the skin near the eye, such as on the temple or upper cheek. The contact patch 210 holds the first electrode 214 in a desired position, while also being coupled by a wire 212 to the frame. The first electrode 214 may be similar to that described above for the first electrode 112 in Figure 3A. Hie contact patch 210 may include a replaceable adhesive or gel element that will secure to the skin of the patient and can be removed/discarded and replaced when desired fixation is no longer provided. The signal or pulse generator circuitry may be provided in any suitable manner, such as illustrated above with respect to Figure 3A.

Figure 4B shows an alternative to Figure 4A. The frame 200, ear rest 230, contact patch 210 and first electrode are as in Figure 4A. Here, a second electrode 224 is provided on the inner canthus by the use of a contact patch 222 that is coupled by a wire to the nose rest 220 Figure 4C shows another configuration in which the first electrode of Figures 4A-4B is omitted, leaving the second electrode 224 coupled to the contact patch 222 and nose rest 220.

Figure 4D shows another alternative. Here, the giasses-type frame of Figures 4A-4C is omitted. A neck worn apparatus 280 is provided as the pulse generator and/or controller for the system and may include an electrode 270 for further remote placement on the neck, head, torso and/or extremity' of the patient. If desired, the separate electrode 270 may be omitted and made integral to the neck worn apparatus 280. A first electrode 252 is placed near the outer canthus with a contact patch 250 used to hold the first electrode 252 in place surd isolate it from any forces applied by a wire that extends from the contact patch 250 to the neck w orn apparatus 280. Likew ise, a second electrode 262 is held in place near the inner canthus using a contact patch 260

In a further alternative, wired connection to the neck worn apparatus 280 may be omitted, and instead a wireless power approach may be used, in which a carrier signal (sonic, magnetic or electrical) is provided by the neck worn apparatus and received by a transducer (for mechanical or sonic power), inductive coil (for magnetic power), or antenna (for electrical power) in an electrical module carried by the contact patches 250, 260. Figure 15, below, provided details for such an example. Figures 5A-5C illustrate various electrodes with fluid retaining structures. Hie examples shown in Figure 5A-5C generally take the form of electrodes having a conductive element, such as a wire, coupled to or contained at least partly within a piece of conductive polymer, a cellulose wicking material (such as WeckCel®), a cotton covering, a natural or synthetic felt covering, or a foam material.

Figure 5A shows a first example in which an electrode has a conductive wire 300 terminating at a distal end. The distal end comprises a huh 302 with a pin 306 having a ring 304 thereon. The fluid retaining structure 310 is a cylindrical element having a bore extending partly therein, and may be made of, for example, an outer portion comprising piece of conductive polymer, a cellulose wicking material (such as WeckCel®), a cotton covering, a natural or synthetic felt covering, or a foam material Hie fluid retaining structure 310 has a bore for receiving the pin 306 with an inner diameter that is less than the outer diameter of the ring 304, such that the ring 304 serves to retain the fluid retaining structure on the pin 306. In an example, the pin 306 is conductive, while the hub 302 and wire 300 are coated or covered by an insulator, so that any current flowing out must go through the pin 306 and the fluid retaining structure 310. By wetting the fluid retaining structure with a conductive gel or fluid, such as saline, fake tears, or any other biocompatible and conductive gel or liquid, the electrode will provide a relatively low impedance tissue interface. When assembled, the electrode may appear as shown at 315. Once assembled, the fluid retaining structure 310 may be ready for use, or, in the alternative, an additional preparation step of dipping or soaking in a conductive fluid such as saline may be performed. The fluid retaining structure 310 may, for example, he used by having it contact the eye itself, the conjunctiva, or canthus, or even by contacting the skin (as the conductive fluid would aid in conductivity of each of these positions). In some examples the fluid retaining structure 310 would be used on one of tire various positioning apparatuses shown in any of Figures 3A-3C, 4A-4D, 6, 7A-7E, 8 and/or 9A-9B.

Figure 5B shows another example. The electrode has a conductive wire 320 terminating at a distal end. The distal end comprises a hub 322 with a pin 324 having an expanded tip, which may be round as shown or may be more of a ring structure instead, if desired. Hie fluid retaining structure 330 is a spherical element having a bore extending partly therein, and may be made of, for example, an outer portion comprising piece of conductive polymer, a cellulose wicking material (such as WeckCel®), a cotton covering, a natural or synthetic felt covering, or a foam material. The fluid retaining structure 330 has a bore for receiving the pin 324 with an inner diameter that is less than the outer diameter of expanded tip, such that the expanded tip serves to retain the fluid retaining structure on the pin 324 In an example, the pin 324 is conductive, while the hub 322 and wire 320 are coated or covered by an insulator, so that any current flowing out must go through the pin 324 and the fluid retaining structure 330. By wetting the fluid retaining structure with a conductive gel or fluid, such as saline, fake tears, or any other biocompatible and conductive gel or liquid, the electrode will provide a relatively low impedance tissue interface. When assembled, the electrode may appear as shown at 335. Once assembled, the fluid retaining structure 330 may be ready for use, or, in the alternative, an additional preparation step of dipping or soaking in a conductive fluid such as saline in ay be performed. The fluid retaining structure 330 may, for example, be used by having it contact the eye itself, the conjunctiva, or canthus, or even by contacting tire skin (as the conductive fluid would aid in conductivity of each of these positions). In some examples the fluid retaining structure 330 would be used on one of the various positioning apparatuses shown in any of Figures 3A-3C, 4A-4D, 6, 7A-7E, 8 and/or 9A-9B.

Figure 5C shows another example. In this example, the electrode has a conductive ware 350 terminating at a distal end. The distal end comprises a port 352 having a release button 354. A tissue contacting element 360 include a conductive wire 362 at its proximal end adapted for insertion into tire port 352, with a fluid retaining structure 364 on its distal end. The fluid retaining structure 364 may be any suitable shape and may be formed on, adhered to, molded with, welded or melted onto, or otherwise secured to the conductive wire 362. The fluid retaining structure 364 may be made of, for example, an outer portion comprising piece of conductive polymer, a cellulose wicking material (such as WeckCel®), a cotton covering, a natural or synthetic felt covering, or a foam material. Hie release button 354 opens the port, which may have a spring loaded catch that releasably secures to the wire 362. To assemble the electrode, the user holds the port 352, depresses the buton 354, and inserts the wire 362. To remove the electrode, the user again holds the port, depresses the button 354, and removes the wire 362. In an example, the wire 362 is conductive, while the port 352 and wire 350 are coated or covered by an insulator, so that any current flowing out must go through the pin wire 362 and the fluid retaining structure 364. By wetting the fluid retaining structure 364 with a conductive gel or fluid, such as saline, fake tears, or any other biocompatible and conductive gei or liquid, the electrode will provide a relatively low impedance tissue interface. Once assembled, the fluid retaining structure 364 may be ready for use, or, in the alternative, an additional preparation step of dipping or soaking in a conductive fluid such as saline may be performed. The fluid retaining structure 364 may, for example, be used by having it contact the eye itself, the conjunctiva, or canthus, or even by contacting the skin (as the conductive fluid would aid in conductivity' of each of these positions). In some examples tire fluid retaining structure 364 would be used on one of the various positioning apparatuses shown in any of Figures 3A-3C, 4A-4D, 6, 7A-7E, 8 and/or 9A-9B.

Figure 6 shows a replaceable electrode apparatus. In this example, the electrode apparatus includes a proximal plug 372, a wire 370 going to a contact patch 374. The electrode apparatus has a tissue contacting part 376 extending from die contact patch in use, the proximal plug 372 can replaceably couple with a port on a pulse generator. The pulse generator may be a wearable product, such as a product that is held on a headband, on glasses-type frames, a neck -worn device, or a pulse generator that can be carried on a belt, pocket or harness by the user. The contact patch 374 includes a tissue adhering surface and is used to secure a position near the target tissue, such as on the temple, forehead, nose or check of the user, avoiding displacement of the tissue contacting part 376 due to movement of the patient and/or the wire 370 tugging on the tissue contacting part 376. Because the electrode apparatus can be removeabiy plugged into the pulse generator, the user can readily replace it after one or more uses. If desired, the contact patch 374 may also be replaceable.

In an example, the electrode apparatus of Figure 6 may be a siugle use device that is packaged with the tissue contacting part 376 impregnated and/or immersed in a conductive fluid or gel, simplifying use for the user who can simply plug the new electrode apparatus in the pulse generator, place the patch, place the tissue contact, and turn the system on, without having to take steps to wet the tissue contacting part 376 prior to use. In another example, a storage tray may be provided and the user may receive instructions on how to place the electrode apparatus in the storage tray with the tissue contacting part 376 exposed to a conductive fluid or gel. In still another example, a storage tray is provided with a replaceable well containing conductive fluid or gel. In some examples, a multipurpose contact solution, which gently disinfects while still being usable directly in the eye (unlike hydrogen peroxide contact solutions) may be used as the conductive fluid or gel, so that between uses the tissue contacting part 376 can be maintained in a hygienic fashion. In still another example, a stronger disinfectant solution, such as a hydrogen peroxide contact solution, may he used to store the tissue contacting part, with tire storage tray/well containing a neutralizing disk for the hydrogen peroxide solution.

Figures 7A-7D show ocular therapy apparatuses in use configurations. Stalling in Figure 7A, a first electrode 400 is shown on the outer canthus and extending to the palpebral conjunctiva 402. of the user. A first lead 404 connects the first electrode 400 to a wearable frame 410 in this example, with the frame 410 further connected to a return electrode 420 by second lead 422. The wearable frame 410 may cany or be connected to a pulse generator for delivering electrical stimulus via at least the first electrode 400. Though portions are omitted, the wearable frame in Figures 7A-7D may in each example resemble, more or less, an ordinary' eyeglasses frame without the lenses, surd may include first and second earpieces attached to first and second aims which each couple to a front portion which extends from one temple to the other of tire user and may include a nose rest. Flexible designs may be used having a unitary' frame; in some examples the front portion of the frame 410 may couple in pivoting fashion to the tw o arms that extend to the earpieces. In some examples, electronics may be housed m the earpieces, such as by having a batten,_' in one earpiece and electronics and a switch in the other earpiece, or by inclusion in the front portion or nose rest are of a frame, examples of each of which are also shown in US Patent App. No. 16/900, 115, filed June 12, 202.0, titled WEARABLE MEDICAL DEVICE, the disclosure of which is incorporated herein by reference.

In an example, the first electrode 400 may have the V-shape shown in Figure 7A, with two arms extending from a junction point. The aims may be flexible to allow movement with the eyelid when the user opens and closes the eye. in some examples, the arms are shorter than the V-shape shown, so that the first electrode 400 is essentially on the outer canthus alone. In another example, a bar-shape is used, rather than a V- shape, and may be placed in contact with the outer canthus and either the superior or inferior palpebral conjunctiva.

In use, in the example shown, the user may first place the frame 410 on his or her head, and then place the first electrode 400. In some examples, the first electrode may be a wet electrode, such as a wettable polymer, or a piece of cellulose, cotton or other natural fiber, carried on a conductive element such as a flexible wire, which has been stored, dipped, or sprayed with a conductive liquid such as saline. If desired, the conductive liquid may include an additive with analgesic properties to add to patient comfort.

Once the frame 410 and first electrode 400 are placed, the user can activate a pulse generator to deliver therapy. The pulse generator may instead sense placement of the first electrode and automatically initiate therapy delivery. In another example, the user places the frame 410 and first electrode and activates the pulse generator, and the pulse generator may confirm suitable tissue contact with the first electrode 400 using, for example, an impedance measurement, prior to initiating therapeutic stimulus delivery.

Figure 7B shows another example. Here, the first electrode 401 is shown as a bar electrode which would contact the outer can thus and a portion palpebral conjunctiva 402. Again the first electrode 401 is coupled to the frame 410 by first wire 404. A second wire 422 couples the (optional) return electrode 420 to the frame 410 as well. A third electrode 432 is coupled to a nose rest 430 The third electrode is placed on the inner can thus.

In the example shown, the third electrode has a V-shape and extends to the superior and inferior palpebral conjunctiva. The V-shape may include flexible arms and/or a flexing coupling of the arms so that the electrode will move with the eyelids when the user opens and closes the eye. The V-shape may be replaced with a bar shape similar to that of the first electrode 401. A button or dot electrode may be used instead, limiting contact to the inner or outer canthus, if desired

In the example of Figure 7B, a plurality of stimulus vectors are defined. In some examples, a pulse generator may deliver a patterned therapy using the multiple available vectors in distinct fashion and/or with distinct aims. For example, a monitoring impedance (or other measurable parameter) while issuing bipolar stimulus between electrodes 401, 432 may provide diagnostic information about tissue/electrode interface, as well as the amount of liquid in or on tire eye (that is, whether dry eye is occurring) A bipolar therapy between electrodes 401, 432 may be useful to stimulate tear production, as it would affect (dilate) the local tear ducts, for example, or to encourage fluid flow in the anterior eye to aid in the regulation of pressure in the interior of tlie eye (for example to treat glaucoma). A monopolar therapy between one or both of electrodes 401, 432 and the return electrode 420 may be used to more effectively target deeper regions in the eye such as the retina or optic nerve. Figure 7€ shows another example. Here, the frame 410 is coupled to the return electrode 420 by wire 422, and is also coupled to an inner canthus electrode 432, winch has a wire 434 leading to the nose rest 430. The example is generally similar to that of Figure 7.4. As noted, the electrode 432 may have a different design or shape. Electrode 432 may be configured as a wet electrode, similar to electrode 400 of Figure 7A.

Figure 7D shows another example. A first electrode 450 is placed on the outer canthus, coupled by a wire 454 to a nearby contact patch 452 to aid in holding the desired position. A second electrode 460 is placed on the inner canthus, coupled by a wire 464 to another contact patch 462. In this example, a wire 466 couples the contact patches together, and another wire 468 connects to a more distant pulse generator 470. In this example, the pulse generator 470 is provided as an ear rest that wraps around and holds to the ear of the user. A return electrode 472 may he coupled to the pulse generator 470. A headband, shoulder harness, or neck worn apparatus may instead hold the pulse generator 470.

In some examples, the contact patches 452, 462 may be replaceable elements of the system. In some examples, the electrodes 450, 460, as well as the coupling wires 454, 464 may be replaceable, for example, by having each contact patch 452, 462 cany a port for removeable coupling to the coupling wires 454, 464. In still other examples, the wire 466 may be removeably coupled to the pulse generator 470, allowing the entire eye electrode assembly (elements 450, 452, 454, 460, 462, 464, 466, 468) to be replaced as one unit.

Figure 7E shows another example. Here, a contact pad 480 is placed on the forehead of the user, with a wire 482 coupled to a pulse generator 484 that may, again be worn at the ear or elsewhere. The contact pad 480 carries an adhesive to hold position on the forehead of a user. The user may be instructed to first clean the site where the contact pad (of this or any other example) rising, for example, an alcohol or salme wipe to remove oil that could otherwise impair adhesion. The contact pad 480 is to be placed on the forehead of the user, preferably above the eyebrow, and provides support to two wires 486, 488 that lead to looped, atraumatic tips adapted to be placed on the lateral and medial canthus 490, 492 as shown. If desired, the contact pad 480 may integrate one or more electrical contacts thereon to serve as additional therapy or diagnostic electrodes. The wires 486, 488 may be resilient but shapeable, such as by using a shape memory material if desired, and are draped down from the contact pad 480 to the desired positions 490, 492 for use. Figure 7F shows one of the wires 486, 488 (here, 486, though 488 may be of like construction) in isolation. The wire includes a first portion 495 having an insulator thereon, with a distal loop at 496 where the conductive wire is exposed. The conductive loop 496 is atraumatic by virtue of having a terminus as shown at 497 where the end of tiie wire itself may be constrained in a shrink-tube, wrapping (such as a tape), or embedded in the insulator of the first portion 495 of the wire 486. Preferably the first portion 495 is relatively stiff but shapeab!e, while the loop 496 is very flexible, and may be made of a material otherwise used as the thread of a DTL electrodes, of which various types are known to the skilled person. Other designs may replace that shown in Figure 7E in some examples.

Figure 8 sho 's another ocular therapy apparatus in a use configuration. Here, an electrode 500 is adapted for placement on the outer (or inner, if desired) can thus. In tins example, the electrode 500 is a button or dot electrode, having dimensions that allow_' placement on the canthus itself or on the canthus and some portion of adjacent tissue such as the palpebral conjunctiva. Electrode 500 is couple via a wire 504 to a contact patch 502. The contact patch 502 prevents patient movement from causing wire 504 to tug on the electrode 500 and displace it. In other examples, an arm or frame may be used instead. Tire electrode 500 may be a w¾t electrode, such as a weltable polymer or natural fiber that is soaked, coated, sprayed or impregnated with a conductive fluid or gel.

Figures 9A-9B show_' an ocular therapy apparatus having a pivoting arm. An electrode 550 is shown on an arm 552 that is atached to a frame 556 by a pivot 554. The frame 556 is shown as having an integrated return electrode 558, which is optional; the return electrode 558 may instead be tethered to the frame 556 by a wire (not shown). The pivot 554 may be spring loaded with at least two "‘stable” positions. One of the positions may be as shown in Figure 9A, which may be called a deployed configuration, in which the arm 552 is directed toward the eye to bring the electrode 550 into contact with the conjunctiva and/or canthus. The electrode 550 may be a wet electrode, such as a wettable polymer or natural fiber that is soaked, coated, sprayed or impregnated with a conductive fluid or gel.

The arm 552 may be an adjustable piece. In an example, a fitting process is performed by a physician, ophthalmologist, optometrist, nurse, clinician, or even by the user, in which the arm 552 is shaped while the user wears the frame 556 turd with the pivot 554 in a deployed position, to bring the electrode 550 into a desired contact position on the target tissue. The shape may then be set by the application of curing light, heat, or similar forming method, if desired, to set a polymer used in the construction of the ami 552, using materials and techniques known, for example, from dental or other arts. For example, materials used in dental implants or replacement products can he cured in place by the application of light: the arm may be provided in a malleable form that can then be shaped and set once shaped using a light source.

In an example, the arm 552 includes a ware extending therethrough, providing stiffness and shapeabiiity, with a curable resin around the wire inside of an outer layer of durable polymer such as a polyurethane, polyamide, or any other suitable material. The arm can be shaped by a clinician and, once a desired shape is achieved, the wire holds the desired shape until a curing light can be applied. Some curable materials usable in tills context include bisphenol A-glycidyl methacrylate (BISGMA), urethane dimethacrylate (IIDMA) or semi-crystalline polyeeram (PEX), which may be combined with a filler such as silicon dioxide, or any other suitable material. In another example, rather than a light or heat curable material, a material may be used which can be generally rigid or stiff w hen cool or at room temperature, and heat may be applied to increase the material flexibility to allow forming the arm to a desired shape, such that the desired shape is retained as the material returns to room temperature.

As shown in Figure 9B, the pivot 554 preferably holds a second, retracted position in addition to the deployed position shown in Figure 9A. In some examples, the pivot 554 is linked to a pulse generator to act as an enable switch in such an example, the pulse generator may have an enable circuit that is closed when the pivot is moved to the deployed position of Figure 9A, and opened (disabled) when the pivot is moved to the retracted position of Figure 9A. When enabled, the pulse generator may begin therapy delivery, may wait for a further signal from a user before starting therapy, and/or may issue one or more test pulses to determine whether tissue contact has been effected and, if tissue contact is effected, therapy begins or, if tissue contact is not effected, therapy is withheld. Electrode 550, alone or alone with some portion of the arm 552, may be a replaceable element.

Figures 1 QA-10C show a replaceable fluid retaining contact on an electrode assembly. In Figure 10A, a tissue interface in the form of a contact member 600 is provide as a wettahie matrix, such as a cellulose or foam, which is to be atached to an arm 610 having a proximal hub 618 and a distal hub 616. The distal huh 616 carries the electrical conductor 612 that will reside inside the contact member 600 when fully assembled. One or more rings 614 are provided to use in securing the contact member 600 onto the electrical conductor 612. The distal hub 616 may itself be insulated on the outer surface thereof to prevent inadvertent shock or stimulus diversion . The proximal hub 618 may be configured to be removably secured in a corresponding bore on a pivot or frame that carries the electrode assembly. The contact member 600 may, for example, be used by having it contact the eye itself, the conjunctiva, or canthus, or even by contacting the skin (as the conductive fluid would aid in conductivity of each of these positions). As illustrated the overall assembly may be used in particular in the example of Figures 9A-9B. In other examples the contact member 600 may be used on one of the various positioning apparatuses shown in any of Figures 3 A-3C, 4A-4D, 6, 7A-7E, and/or 8.

Figure 10B shows the contact member 600 in section view. The contact member 600 defines a bore 602 for receiving the electrical conductor 612 (Figure 10A). For purposes of securing the contact member 600, the bore 602. may include one or more indents 604 for receiving the rings 614. In some examples, the contact member 600 may include a first portion of a flexible polymer to define a portion of the bore and indents, while a second portion is made of the wettab!e material, including at least the distal tip 606 Such a construction may also be used in the example of Figures 1 1 A- 1 ID, below, as contact member 660.

Figure IOC illustrates the complete assembly, with the contact member 600 advanced over the electrical conductor (not shown). The contact member 600, when fully placed on the arm 610, may abut against the distal hub 616. The process may be performed manually, however, it is anticipated that with users who need therapy for a vision disorder, a manual process may be difficult if it requires manipulation of small parts. If the contact member 600 is pre-wetted, manual placement may be inconvenient as it will cause some of the fluid to be expelled during manipulation of the contact member 600, requiring cleanup and reducing the fluid present during therapy.

Figures 1 lA-1 ID show a tray and method of replacing a contact on an electrode that may make for an easier process and less mess. Starting with Figure 1 1A, a tray 640 contains a number of w'ells 642, 644, 646. As illustrated with well 644, each well contains a reservoir 650 of conductive fluid m which tissue interface in the form of a contact member 660 is held, with a collar 654 attached to the top end of the contact member 660, and a removeable seal 652 provided over each well to maintain a hygienic and water tight seal. The tray 640 is shown with three wells 642, 644, 646; it will be understood that the tray 640 may have a single well or may have as many wells as desired, for example, 7, 14, 30, 60, or more or fewer wells may be provided on a single tray 640. The fluid in each well may be, for example, a conductive fluid such as saline. The fluid is preferably chosen to be one which does not irritate the eye and/or the conjunctiva.

As shown in Figure 11B, the seal 652 has been removed to expose the upper end of the contact member 660. The collar 654 will generally retain the fluid in the well 650 as it rests in a collar seat at the top of the well. For illustrative purposes, the contact member 660 is shown in Figure 1 IB in a section view, to allow the bore 662 to be seen. An arm 670 for earning the contact member 660 as part of an electrode assembly is shown. The arm 670 includes a distal hub 672 from which the electrical conductor 674 extends, again with one or more rings or other retaining members 676 provided on the electrical conductor 674. As indicated by arrow 680, the user is to advance the arm 670 toward the tray 640, and will insert the electrical conductor 674 into the bore 662 of the contact member 660.

An optional feature highlighted in Figure 1 IB is that the well 650 may comprise a neck 656 that has an inner diameter that is less than the outer diameter of the distal end of the contact member 660.

As shown in Figure 11C, the arm 670 can be advanced until the distal hub 672 is in contact with the collar 654. Again for illustrative purposes tire contact member 660 is shown in Figure 11C in section view. This full insertion will engage the retention members (such as the rings shown in Figure 1 IB) of the arm 670 with the interior of the bore of the contact member 660. During this insertion step, the collar 654 prevents the fluid withm the reservoir 650 from escaping. Next, the user will withdraw tire arm 670 from the tray 640, as indicated by arrow 680.

Figure 11D shows the product now ready for use. Again, the contact member 660 is shown in section view for illustrative purposes. The arm 670 now carries the contact member 660, which is wetted by virtue of having been held in the reservoir. Tire collar 654 abuts the distal hub 672. The arm 670 may now be placed on a pivot or frame for use, as shown in Figures 12A-B, below. The user may replace tire seal 652 to prevent any remaining fluid in the reservoir 650 from spilling, if desired. The seal 652 may be transparent to allow the user to readily determine which wells of the tray 640 still contain contact members. It may be easier to simply turn over the tray 640 and diimp any remaining fluid down a sink, if desired, so that the user does not have to bother with replacing a used seal 652.

Figure I2A shows a replaceable arm for carrying an eye-stimulation electrode. The arm 700 is shown having a proximal hub 710 and a distal hub 720, with a shaft extending therebetween. In one example, the proximal hub 710 may contain a magnet 712 that aids retention in a receptacle 730 that is provided on a frame or pivot for use therewith. The receptacle 730 may include an irregular shape, such as the offset, scalene triangle shown at 732 to receive the proximal hub 710, which would have a shape to match the receptacle in only one orientation. Other shapes may be used. As a result, the user can only place the arm 700 relative to the receptacle 730 in a single orientation, avoiding user error by misplacing the arm . If a frame has more than one receptacle (for delivering therapy to both eye as once, for example.) each receptacle would have a unique shape, ensuring that, for example, only left arm coidd be placed in the left receptacle. The receptacle 730 may include one or more magnets to atract magnets 712 or, in the alternative, may compose a ferrous material to which the magnet 712 will be attracted. In another example, the receptacle 730 comprises the magnet, while the proximal hub 710 comprises corresponding magnets or a ferrous material to which the magnet of the receptacle would be attracted. In some examples, the construction may be described as having a first attractive element in the proximal hub, and a second attractive element m the receptacle, wherein at least one of the first and second attractive element is a magnet and the other is either a magnet or a ferrous material.

The shaft is illustrated in section view' in Figure 12.4. Here, the conductive ware 702 is shown within a shaft body 704 which may, as noted above, be a flexible polymer capable of light curing when a desired shape is achieved. The shaft body may instead be a polymer that is rigid w'hiie cold but which allows reshaping w'hen heat is applied, if desired. The distal hub 720 comprises a retaining member 722 for securing a contact member on the electrical conductor 724

If a single conductor 702 is used, the proximal contact 714 will be a single contact, and the electrical conductor 724 may be a single contact as well, coupling to a contact member. Figure 12B shows a multi-conductor alternative. Here, the arm 740 has two conductors 742A, 742B passing therethrough and coupling to first and second output contact nodes 744 A, 744B. At the proximal end of the arm 740, first and second contacts 746A, 746B are provided, which would couple to first and second contact regions in the receptacle, separated by an insulating region. The tissue contact itself may have first and second conducting regions 749A, 749B, separated by an insulating portion 749C. In this way, for example, superior and inferior contacts may be provided at the inner or outer canthus, or first and second contacts may be provided along the superior or inferior lid margin of a user/patient.

Figures 13-14 illustrate, in block form, methods of treatment. Starting with Figure 13, an illustrative method comprises preparing a therapy apparatus 750, a step the patient may perform on him self /herself, or which may be performed by another person. In some examples, a skin or tissue contact may be pre-weted, such as by application of a liquid by spraying, dipping or soaking m a conductive liquid, as indicated at 752. Additionally or alternatively the skin interface, such as a gel or adhesive pad, may be replaced as indicated at 754, whether in the context of single use skin contacts, or reusable skin contacts that are replaced from time to time. In some examples, preparing the therapy apparatus comprises only preparing the electrodes, while m other examples a pulse generator is also“prepared^”. For example, the pulse generator may be turned on or enabled using a physical switch, if desired, it may be charged to replenish a rechargeable power source (battery or capacitor for example), and/or it may be paired with a user remote control such as, tor example, if the remote control for the user is provided as an application run on a smartphone or tablet computer, radiofrequency pairing of a pulse generator and the remote control may be performed to prepare for therapy. Once enabled or turned on, the pulse generator may go through diagnostic and/or initialization procedures prior to therapy being available, if desired.

The user then positions the apparatus for therapy delivery', as indicated at 760. Alternatively a caregiver or other person may perform step 760 This placement may include direct placement as indicated 762, in which the electrical contact itself adheres to tissue to hold a position. Additionally or alternatively, a frame, such as an eyeglasses frame, nosepiece, earpiece, headband, visor, cap or hat, may be used to support the electrode position as indicated at 764. In still other examples, a separate adhesive patch 766 may be provided to augment positioning of the electrical contact. In some examples, the apparatus may be placed on the head, neck or torso, for example.

Next, the system is activated, as indicated at 770. Activation may be performed by the user actuating a switch as indicated at 772 on, tor example, a frame, patch, or signal generator housing. Additionally or alternatively, the apparatus may be equipped to sense positioning 774, such as to sense temperature at the tissue interface, to sense impedance between electrical contacts, or to sense the galvanic skin potential without injecting a current. Additionally or alternatively, a remote control, such as a user^'s smartphone, may be used to activate, as indicated at 776. In some examples, both a user input, such as via a switch 772 or remote 776, and device sensing 774 may be used to activate the device.

A therapy session ensues, as indicated at 780. In some examples, a therapy session may be performed to generate phosphenes as a marker of whether therapy is being correctly delivered both m terms of spatial targeting and intensity (which may encompass frequency, pulse width and/or amplitude), as indicated at 782. For example, the patient may be provided with a remote control or other feedback device to allow the patient to report observation, or lack of, phosphenes. In another example, electrical signals in and around the eye may be monitored to determine whether phosphenes arc occurring as part of block 782.

In some examples, a therapy target may be“subthreshold,” 784 wherein the subthreshold approach calls for setting intensity below a phosphene-generating intensity by adjusting one or more of frequency, pulse width, and/or amplitude to prevent, eliminate, and/or avoid phosphene generation.

There may be several approaches to configuring a subthreshold therapy regimen. In one example, a user undergoes phosphene threshold-setting periodically under clinical supervision, and one or more of amplitude, pulse width or frequency is then modified to stay below a determined threshold. In another example, during a given therapy session 780, the user may undergo a phosphene thresholding exercise in which therapy is turned on and one or more parameters are varied (such as by raising amplitude or pulse width) until the user observes phosphenes and provides feedback via a remote control, a pulse generator, or by taking an action such as touching a button on a supporting frame. The user may be instructed to blink several times, for example, to provide a feedback that does not require use of the bands during phosphene threshold seting. Next, one or more control parameters are modified to reduce intensity, such as by one or more of using a narrower pulse width or setting a lower amplitude for a therapy output, or by modifying frequency.

Phosphene threshold setting may be performed separately for each eye, if desired. In addition, phosphene threshold setting may be periodically performed during a session, or it may be performed at the start of a session, or even less frequently as in once a day, once a week, etc. The patient may be allowed to trigger phosphene threshold setting by pressing a button, for example, on a patient controller or on a therapy delivery apparatus, if desired, in response to the patient observing phosphenes during what is supposed to be a sub-threshold therapy session.

For example, once a phosphene threshold is determined, one or more parameters may be adjusted by some percentage (10%, 20%, 30%, 40%, 50%) or fixed amount (increase or decrease pulse width by 1 to 100 microseconds, decrease amplitude by 1 to 100 millivolts or 0.1 to 10 milliamps, or a different amount). A phosphene threshold may be determined at more than one frequency to allo a multiple frequency therapy, such as by establishing the phosphene threshold at two or more frequencies, thereby enabling a therapy regimen that uses each two or more frequencies in an alternating or other patterned manner. A software solution may automatically perform each of thresholding and subsequent parameter setting, for example. By using a subthreshold therapy regimen, the user is allowed ordinary_' vision during therapy, as the phosphenes generated by a supra-threshold therapy may be distracting or may interfere with performing desired activity such as light chores, watching television, reading, etc.

A therapy session 780 may include the provision of one or more programs 786 that combine more than one therapy type in a sequential or interleaved manner. A sequential therapy program may deliver an output at, for example, a first combination of frequency, pulse width, and/or amplitude, followed by second, third or more combinations. For example, therapy may be delivered at several frequencies over time, such as by delivering a first therapy at a first frequency for a first duration, followed by a second therapy at a second frequency for a second duration, etc. In some examples a program may use different electrode combinations to provide a spatially diverse output, such as by using two close-placed electrodes in a monopolar fashion to target structures in the anterior eye (to enhance tear generation or to encourage fluid flow through the trabeculae), and a bipolar approach with one or more electrodes on the conjunctiva of the eye and a remote electrode to target structures deeper in the eye, such as the retina or optic nerve. Such therapy may be interleaved by delivering one or more monopolar pulses betw een bipolar pulses.

A therapy session is then closed, as indicated at 790. Session closing may include testing the patient 792 such as by requesting the patient perform a skill test of visual acuity, for example, and requesting the patient answer one or more questions that may be helpful to understanding therapy success or disease progress. Closing a session may comprise recording diagnostic data 794 related to the output therapy provided (frequency, amplitude, pulse width), measurable parameters during such therapy (impedance being one such measurable, as well as measured/observed phosphenes), and any patient test data. In some examples, a system may comprise a motion sensor to detect eye movements during a therapy session, and such motion may be recorded as well. Any such data may further be offloaded as part of a therapy session by sending to a remote site via the internet through wired, WiFi, or cellular connection, or to another device using, for example, WiFi or Bluetooth communication; in an example, a patient data repository may be provided and accessed via the internet, and closing a session may comprise sending device usage, history and/or diagnostic data to the repository_'. Optionally a physician may be provided access to the patient data repository' for purposes of tracking patient compliance, response to therapy, or any other desirable use .

Figure 14 shows another method of treatment. Here, the device is first enabled, either automatically 802 or by user input 804. Automatic enablement 802 of the device may comprise, for example, placing the device and in so doing actuating a switch, such as by donning an eyeglasses frame that carries a moveable arm with a tissue contact thereon and then moving the arm to close (or open) a circuit which enables a therapy output. Automatic enablement may instead use a temperature sensor to detect that the tissue contact, or other part of the wearable apparatus, is being worn on the patient, by- sensing the galvanic skin potential, or by sensing a change in impedance between therapy electrodes. User enablement 804 may be performed by the user pressing a button or toggling a switch on a wearable apparatus or a pulse generator coupled to a wearable apparatus, or by entering an input on a remote control device.

Next, the wearable device or system confirms correct placement at 810. This may include checking impedance 812 between the various possible therapy delivery- vectors or between any pair of contacts coupled to patient tissue. Thus, for example, a gross check of impedance may be performed between a remote electrode and a tissue contact placed near the eye to provide an enable signal at block 800, with a finer check performed next between each electrode of a system (which may include right and left eye electrodes, or plural electrodes placed near or on one or both eyes) to confirm 810 that all electrodes are in appropriate places, and/or to eliminate any electrodes that do not show good conduction to the tissue. Stimulus is then provided as indicated at 820. A user may adjust stimulus by providing feedback via a remote control or via a user interface on a pulse generator, as indicated at 822. A closed loop system 824 may be provided that adjusts stimulus intensity in response to detection of phosphenes occurring, or by detecting changes in impedance such as would be expected if a tear-inducing therapy output is generated as part of a program (block 786 of Figure 13). For example, if impedance is within an acceptable range for therapy delivery, but is not optimal, a program for bipolar therapy targeting the anterior eye and tear production may be enabled until the sensed impedance is reduced by the added fluid being generated in and around the eye, leading to cessation of the bipolar therapy targeting tear production while keeping a second therapy targeting the retina operating.

In addition to the feedback loops at 822, 824, the system may continuously or non-continuous!y recheck the tissue interface, as indicated at 830, by returning to block 810 and checking a set of impedance measurements. In some examples, therapy outputs are generated and monitored (i.e., a fixed current is generated and voltages are monitored, or a voltage is generated and current is monitored) to obtain gross impedance characteristics during monopolar outputs for therapeutic purposes, and the recheck 830 may include monitoring more impedance values to confirm continued appropriate device placement. For example, if the user has two electrodes on the inner and outer canthus of one eye, and a return electrode is elsewhere on the patient, a stimulus-based impedance measurement will provide information about impedance that may be subject to variation due to patient postural changes, making it difficult to ensure that the two canthus-located electrodes each remain in good contact. Therefore therapy may be interrupted from time to time to deliver a local current between the two canthus- located electrodes to confirm good contact tor each of those electrodes.

If electrode contact is not confirmed during recheck 830, therapy may be interrupted to request the user reposition, rewet, or replace one or more of tire tissue contacts. Confirmation is again performed at 810, and the stimulus 820 can restart. The session continues until a target is reached, which may be, tor example, to deliver the therapy for as few as a few minutes up to an hour. In some examples, therapy may be delivered for 15 to 30 minutes. The session is then closed as indicated at 840, which may include storing and/or uploading session details as well as performing diagnostic or patient test activities as described relative to block 790 in Figure 13. Figures 15-17 show illustrative electrical component architectures. In Figure 8, a power block 870 is provided and can be a rechargeable or non-reeliargeabie battery. An application specific integrated circuit (ASIC) is included at 874 and couples the power 870 to input/output (I/O) 872, which may alternatively be integrated in the ASIC 874, if desired. The ASIC 874 may include control circuitry, memory', and various operational circuits such as current or voltage sources, operational amplifiers, filtering circuitry, etc. as the skilled artisan will recognize may be used to control device operation. For example, the ASIC 874 may comprise circuitry defining a state machine, or may include a microprocessor. The ASIC 874 may include memory for storing instructions, diagnostic data, usage history , or any other suitable data to be retained or used . In other examples, an ASIC 874 may be omited and replaced with discrete electronic componentry, such as, for example, a microprocessor or microcontroller with associated memory' and any suitable electronic hardware. A field programmable gate array package may be used as well, if desired, to provide additional circuitry .

The I/O 872 can couple to the wires that attach to the electrodes. A set of switches, for example, may be included in I/O as well as buffering or protective circuits such as DC blocking capacitors. A communications block is shown at 876 and may be, for example, MedRadio telemetry block, an inductive telemetry circuit, or a Bluetooth™ circuit, such as a Bluetooth™ Low Energy (BLE) circuit, having an antenna and related circuitry (such as a crystal oscillator) for performing telemetry- using RF energy. In this example, a programmer 878 can be a programming device that provides a set of instructions executable on the ASIC 874, which may include or be implemented as a field programmable gate array or other field programmable element to deliver a planned therapy regimen. In oilier examples, therapy output may be commanded by the programmer 878, such that the product itself stores no information about the desired therapy and simply receives commands to issue outputs of duration, amplitude, frequency, etc. set by programmer 878. lire programmer 878 may be a dedicated device or may be a multiuse device, such as a smartphone or tablet computer.

Figure 16 shows another example, except in this case the charger/programmer 888 provides both telemetry and power to the device. In tins example, the I/O block 880 is configured to receive therapy output signals from the ASIC 882. The ASIC 882 receives both power 884 and communications 886 from a charger/programmer 888. The components for each of 880, 882, and 886 may be similar to those of Figure 15. In this example, the power receiving circuitry may include, for example, a rectifier and capacitor configured to receive electrical power from a receiving element, such as an inductive coil and/or an RF antenna, or a transducer such as a piezoelectric element or ultrasound or optical receiver, any of which may be powered by the charger/controller 888

lire signal that carries power may also carry data and/or commands from the charger/programmer 888, and so there may be shared components between the power 884 and communications circuit 886. For example, if an RF signal is generated by the charger/programmer 888, an antenna may be shared by the power and communication 884, 886 blocks, with the communication block 886 having demodulation circuitry configured to extract data from tire carrier signal of the RF signal, while the power circuit captures the power from die carrier signal. Likewise, an inductive communication and power signal may be generated by the charger/programmer 888. In other examples the eharger/programmer 888 may provide more than one signal, such as an inductive signal captured by an inductive coil in the power block 884 and an RF or optical signal received by the communication circuit 886. The communicated data or commands may, for example, set parameters for therapy delivery (amplitude, pulse width, shape, frequency, pattern, electrode selection, etc.), and the ASIC 882 can then cooperate with the I/O 880 and power block 884 to provide the commanded therapy to tire user. For this example, the system may omit a separate power storage element in the form of a rechargeable battery, and include instead a shorter term electrical storage element such as a relatively simple capacitor circuit, or capacitor block, as needed, to provide therapy only during a communication session with the charger/programmer 888 or only for a limited period of time after the charger/programmer 188 ceases to deliver a signal .

Figure 17 shows another example. Here, the separate device is now a controller 890 that provides an output signal that is received by a transducer circuit 892, which directly feeds a signal to the I/O The transducer circuit 892 may directly convert received signals into output electrical signals, for example, by passing a received inductive, RF, optical, or mechanical signal (such as ultrasound) directly to the user through tlie I/O after conversion to electrical energy/current. The transducer 892 may serve to condition the received power, such as by smoothing, rectifying, and/or limiting power passed through. The example shown in Figure 17 may use principles similar to those used by an RFID chip, for example. For therapies disclosed herein, waveshape may vary. If desired, sinusoidal triangular, ramped (up or down), exponential (up or deeaying/down), or square waves may be delivered in any of current, voltage, or power controlled outputs. For example, a current controlled output may provide a square wave of constant current for its duration. In another example, a voltage controlled output may take the form of an exponentially decaying output. Other combinations and shapes may be used if desired. In some examples, an output circuitry of the electronics module may be configurable between a first configuration that delivers current controlled outputs and a second configuration that delivers voltage controlled outputs. For example, a first feedback loop may be provided that monitors voltage across the output electrodes (for voltage control), while a second feedback loop monitors voltage across a resistor (for current control) that is in series with the output electrodes, and the controlling circuitry such as a microprocessor, ASIC, or state machine, can be programmed to select one or the other of the output types and feedback loops to use.

In some examples, the output waveform may comprise a modulated carrier wave, such as a modulated 1 Hz to 1 MHz output, shaped as a sinusoid or square wave, higher or lower frequencies may be used In an example, a carrier wave takes the form of a square wave with a frequency of 1 kHz to 40 kHz and 50% duty cycle, modulated by a signal of a lower frequency, as discussed in US Patent No. 7,251,528, the disclosure of which is incorporated herein by reference. The duty cycle may be anywhere from I% to 100%, if desired. The modulating signal may be a square wave in the range of about 1 to about 100 kHz, more preferably about 1 to abou t 1000 Hz, or about 1 to 400 Hz. In another example, the envelope may be at a selected one of 10, 20, 30, 40, 50, 100, 200, 300, 500 or 1000 Hz; other envelope frequencies may be used. In still another example, the user may receive a series of different frequency outputs, by varying the modulating frequency and/or varying the carrier frequency. Tire carrier wave or tire modulating signal may be sinusoidal instead, if desired, or may have a different shape such as triangular, ramped, etc. In some examples, additional factors may be programmable parameters, such as duty cycle, pulse width of the carrier signal or envelope signal. In an example, a monopolar output is provided, with periodic changing of the polarity to maintain charge balance at the tissue interface. For example, some embodiments of a wearable therapy apparatus provide a stimulus output as a first train of monophasic output pulses of a first polarity, and a second train of monophasic output pulses of polarity opposite the first train. In other examples therapy output may be allowed to leave a residual charge imbalance.

In another example, a therapy signal is provided with a frequency of about 1 Hz to about 1 MHz, and the combination of earner and modulator or envelope is omitted . For example an output may be provided as a biphasic square w ave with a frequency in the range of 10 Hz to 20 kHz, or about 100 Hz to about 15 kHz, with the output delivered for a fixed period of time such as 1 millisecond to about 1 hour, or about 100 milliseconds to about 30 minutes. Tire waveform may be delivered repeatedly, at fixed or random intervals, or in bursts, and may take other shapes including triangular, sinusoid, etc. Therapy signals may be delivered with a soft turn-on or ramp, in which the therapy output signal is ramped up from a starting level {such as 0 volts or 0 a ps) up to the desired therapy level over the course of a few' milliseconds to a few seconds, or longer. Other parameters including pulse width, off time, polarity switching frequency (if used), etc may vary as well. In another example, an output therapy may be delivered in a frequency range of about 1 to about 300 Hz, or 10-30 Hz, or 20 Hz. In some examples, the envelope/modulation approach is used with a carrier frequency of about 10 kHz and a modulation frequency of about 1 to about 300 Hz, or 10-30 Hz, or 20 Hz.

A programmable amplitude may be set as well using, for example, power, current or voltage as the controlled variable. In some examples, current may be delivered in the range of about 0.1 to 2000 microamperes, or in the range of about 1 to about 1000 microamperes, or in the range of about 300 to 500 microamperes, using any of the above noted parameters for waveshape, frequency, duty cycle, etc. Pulse width may be selectable in the range of about 1 nanosecond to about 1 second, though longer or shorter pulse width may be used. In some examples, the pulse width is defined in a microsecond range, for example, between 10 and 100 microseconds.

For example, an output of less than one volt, or less than one milliamp of controlled current, may be provided, with a pulse rate in the range of 0.05 Hertz up to as much as 20,000 Hertz, or 0.1 Hertz up to 1 ,000 Hertz. Outputs may be in the range of 100 nanoamps, or 100 nanowatts, or 100 nano volt, or lower, if desired, up to the range of microamps, microwatts, or microvolts, or up to the range of mdliamps, milliwatts, or millivolts, or higher. In some examples, the impedance encountered may call for voltage or power to exceed 1 volt and/or 1 watt, though current in many eases will remain below 1 amp. In an example, the maximum current may be 10 miiliamps; other limits may be set as needed for patient or user safety. In some examples, voltage may be as high as 1 volt, or as high as 50 volts.

The duty cycle of any therapy output may be controlled as well for example between 1% to 100% duty cycle may be use. As used herein, duty cycle refers to the duration of time a selected frequency output is ongoing, including quiescent time during such frequency output, referenced to total time. Thus, a 50% duty cycle may be achieved with a 1000 Hz signal delivering a 50 microsecond monopolar output on for one second and off tor one second, even though the active output time period in that example would be far less than 50%. As used herein, the frequency measure“Hertz” is used to refer to pulse repetition rate in pulses per second.

A sequence of therapy may be delivered with one or more of frequency, amplitude, pulse width, waveform type (i.e. monophasic or biphasic, current controlled or voltage controlled, etc.) changing within different parts of a session. The output waveform may be tailored to a range of expected impedances such as between 10 ohms and 1 gigaohm, or 500 ohms to 10 megaohms, or 1 to 100 kilohms, tor example. In some examples, the output waveform may be defined in part by a maximum charge per pulse, for example, less than a set quantity of coulombs (such as less than 500 n€ at a load of 500 ohms, tor example).

The user may be allowed to freely modify parameters, or access may be restricted to a clinician user, or it may be that the user can modify parameters within a narrower range controlled by a clinician. For example, a clinician may be enabled to set current in a range of 1 to about 1000 microamperes, while the user can only modify the current, once set by the clinician, within a range of plus/minus 100 microamperes, or more or less. Thus there may be separate clinician programmer devices or user interfaces and patient controller devices or interfaces. Other specific settings may be used. In some examples, the user may not be allowed to change parameters.

In some examples, a closed loop approach may be taken wherein sensing circuitry in the apparatus is configured to sense select parameters of therapy delivery or sense other parameters, such a biological events. For example, it has been shown that users may experience flashes of light, known as phosphenes, during therapy. To allow a user to perform ambulatory or other activities, phosphenes may be avoided by having the device sense for phosphenes and reduce power output when phosphenes are sensed to limit the impact to a user s visual experience. Another approach may be to occasionally or periodically test a user’s phosphene threshold, such as at the start of a therapy session, and then set therapy parameters to use duty cycle, amplitude, current density, or other factor so therapy stimuli is delivered at a level that is below the phosphene threshold. Such testing may further include having a user move his or her eye to different positions during threshold testing l i e. looking up, down, left or right) by issuing one or more commands to the user to modify eye position during phosphine threshold testing.

An optical interrogation can be used to capture an image of the retina or other structures in the eye, or may be used to detect eye movement either generally or as part of diagnostic or user performance testing. Such information may be captured a part of the overall testing and diagnostic activity.

The ability to select from various pairing of electrodes may be useful to provide therapy targeting separate conditions by selective use of the electrodes. For example, glaucoma is typically associated with fluid transport structures in the eye that are more superficial, anatomically, than structures associated with a condition such as macular degeneration. Therefore, in an example, relatively more closely spaced electrodes, or bipolar therapy regimens, may be used to treat conditions in the anterior region of the eye, such as by modulating fluid outflow rates to treat glaucoma, or to trigger tear production, while more distantly spaced electrodes, and/or monopolar therapy regimens may be used to effectively target deeper structures in the eye such as the retina, for example to treat macular degeneration, for a user having or at risk for multiple conditions. Such regimens may be combined in a single therapy session in sequential or interleaving fashion, as desired.

In a still further example, a current flowing between two electrodes on one eyepiece may be useful in glaucoma patients to cause contraction or expansion of the ciliar muscle regions, opening the iris root and facilitating drainage through the trabecular meshwork. In some examples, a current applied by an eyepiece may energize a stent placed in the trabecular meshwork to aid fluid flow, or to energize a device placed elsewhere in the eye to cause other beneficial therapeutic effects such as heating, light or electrical stimulus affecting neural structures in the eye. In examples it is envisioned the bipolar electrode positioning around an eyepiece can provide selected stimulation to rehabilitate an atrophied ciliary muscle before or after implantation of an artificial intraocular lens. In still other examples, other structures in the head may be targeted, such as the optic nerve and/or targets in or around the brain, the sinuses, or the eye. Multiple therapy patterns or programs may be set for a single device. For example, the electrical components may comprise a state machine or microprocessor architecture with stored states or stored instructions, respectively, to deliver pre selected therapy patterns or types. Therapy paterns may be defined according to which electrodes are selected for use (and in which role - ground, indifferent, isolated, anode, cathode, etc.), as well as waveform characteristics for each output channel (pulse width, frequency, amplitude, relative amplitude, pulse shape, duty cycle, inter-pulse intervals, burst patterns, etc.). Such patterns or programs may be set by a physician during a programming session using, for example, a clinician device such as a mobile phone, table or computer, or a dedicated programmer device, as desired.

US Patent 7,251,528 to Harold, US PG Pat. Pub. No 2020/0101290, titled SYSTE AND METHODS FOR CONTROLLED ELECTRICAL MODULATION FOR VISION THERAPY, US Patent App. No. 16/697,689, filed on November 27, 2019, titled HEAD WORN APPARATUSES FOR VISION THERAPY, US Patent App. No. 16/844,421 , filed on April 9, 2020, titled SYSTEMS AND INTERFACES FOR OCULAR THERAPY, and US Patent App. No. 16/900,115, filed June 12, 2020, titled WEARABLE MEDICAL DEVICE, are each incorporated herein by reference as showing various features electrical therapy (and other modes of energy delivery') directed to the eye. Hie designs and features discussed herein may be implemented in combination with the features of any of the apparatuses and methods in any of these patents and patent applications. Other structural approaches to electrode placement may be used, as shown, tor example, in any of these patents and/or patent applications.

In any of the above examples, an electronics module may be provided as a separate pulse generator that is coupled by wire, or by a wireless coupling such as an inductive or RF link allowing power transmission to a wearable device. Such electronics may comprise signal generators such as are known in the art, including constant current supply circuits, voltage supply circuits, frequency modulators and/or generators, etc , which may be provided as part of an application specific integrated circuit (ASIC) or via discrete components on a circuit board or flex circuit. Sensing elements and/or transducers for outputting therapy (sonic, optical, magnetic) may be included in place of or along with electrodes that contact the tissue. Power may be provided by non-reehargeable or rechargeable batteries. For example, the electronics may include a rechargeable battery that can be recharged by plugging in a charging plug, which may be a standard plug such as mini-USB, or other standard design, type, or size, or may be a custom plug. In another example, a storage ease may be provided that has contacts or a transducer for inductively recharging a batery.

For battery power, any suitable chemistry_' or structure may be used for the batteries. For example, batteries similar to those used for hearing aid devices may be used, in either rechargeable or non-recharg cable forms. Chemistries such as Zinc -air, Nickel metal hydride (NiMH), Lithium-ion (Li-ion), and Silver-zinc (AgZn), may all be suitable in various embodiments. Recharge of batteries may be performed by direct, wired connection or by wireless coupling of an inductive element or antenna, or any other suitable method. In some examples, a batery_' may be omited and a capacitor or supercapacitor used instead, allowing charging and discharging over time. For example, a receiving antenna or inductive coil may receive energy output by a remote device and the received power can be used to charge a capacitor. Once the capacitor is charged to a desired level, the capacitor can be discharged to deliver therapy to the user. A determination that the capacitor is at the desired level may be made by, for example, having a comparator in the system to compare to a reference voltage, or by having a silicon-controlled rectifier that, once the desired voltage level is reached, will close a switch allowing discharge of the capacitor and open again once the capacitor is discharged to at least a threshold amount.

In still other examples, therapy output may be generated by a separate power source with transmits power wirelessly, such as by RF or inductive power transfer, to power and trigger therapy outputs by the device. Here, the receiving element in the device may be more or less directly coupled to the output electronics and electrode(s).

Total mass of the eyepiece may be kept relatively small, such as in the range of less than about 50 grams, or less than about 25 grams, or less than about 15 grams, or less than about 10 grams, in order to make it easier for a mechanical and/or adhesive approach to securing the eyepiece in place readily achieved. In one example, the total mass of the eyepiece is in the range of about 5 to about 15 grams. In another example the total mass is about 3 to about 10 grams. Such masses may exclude the mass associated with liquid or gel-based contact enhancements.

As a numerical and non-limiting example, the typical output for the system may be in the range of less than about two milliamps, delivered over the course of a 20 to 30 minute treatment session, into a load of 3000 ohms or less. The duty cycle may be in the range of 50% or less, even down to less than 10%, if desired. For example and without limiting the invention to these quantities/numbers, a 30 minute session at 2 milliamps average battery current would deliver current at a peak output amplitude of 6 volts. Batteries suitable to such requirements are commercially available, such as zinc-air, or zinc-silver chemistries, and/or Lithium chemistries.

In some examples, a battery' circuit comprises a plurality of rechargeable battery cells, either in one battery or in a battery stack, configured, at full charge, to provide about 10 to about 20 milliamp hours of current capacity at an output voltage of 6 volts or more, capable of providing at least two milliamps of constant current for a duration of at least 30 minutes, which would, in this non-limiting example, provide a system able to deliver therapy for a full week on one charge. Other examples may use different capacities and metrics, as well as different battery types, or no battery at all.

In another example, parameters such as stimulus frequency, pulse width, amplitude, electrode selection, and combinations thereof may be reprogrammable. In some examples, wireless reprogramming may be used, such as via any suitable wireless protocol and frequency (Medradio, Bluetooth, Bluetooth Low Energy, WiFi, cellular, inductive telemetry', IEEE 802 protocols, etc.), or by using, for example, optical (such as infrared communication) or magnetic coupling, or mechanical coupling (ultrasound, for example). Wired reprogramming may be used, for example, if the device comprises a port for plugging a USB or micro-USB plug, or any other suitable coupling including both electrical and optical cables. Reprogramming may include selecting, or changing therapy parameters such as amplitude, pulse width, frequency, duty cycle, shape, ramping, electrode selection, pulse shape, pulse type (current controlled or voltage controlled, for example), and any other suitable characteristic. A communication session may include retrieval of diagnostic information as well, such as electrical signal feedback, motion, impedance sensed at tire electrodes, optical interrogation results, patient performance test results, etc.

In some examples, the electrical components used to deliver electrical therapy via the electrodes may include a multi-channel topology. Separately addressable voltage and/or current sources may be used, having one source, two sources, or as many such sources as there are electrodes, if desired, or even with more sources than electrodes. Some sources may output current (current sources) or drain current (current sinks), while others may provide positive or negative voltages relative to system ground/reference. In some examples, there may be dedicated voltage or current circuits for each electrode while in other examples, a bank of voltage or current generating circuits may be coupled by an array of switches or a multiplexor to the output electrodes, allowing therapy generating circuits to be ganged together on a single output electrode or spread out across several electrodes.

Miniaturization of a neural stimulator has been taken to great lengths including providing communicat on, pulse output, power storage and/or control circuitr ' in implantable devices of just a few grams and cubic centimeters, such as shown in US Patents 5,193,540 and 8,612,002, the disclosures of which are incorporated herein by- reference . Moreover, the provision of multiple channel outputs has been shown as well, including for example in US Patents 5,643,330 surd 6,516,227, the disclosures of which are incorporated herein by reference. If therapy is configured to be subthreshold or imperceptible to the user, it may be useful to provide a non-therapy indicator or annunciator to the user. In some examples, the user may use a switch or user remote control to turn therapy on and, to confirm the on state, a speaker, light, or other annunciator may be used to indicate that therapy has been turned on to the user. Such annunciation may again be used if therapy is turned off by the user, or when a therapy- session is completed. For any of the examples herein, a remote power source may be provided around the neck of the user using examples as shown in U S Patent Application No. 16/697,689, titled HEAD WORN APPARATUSES FOR VISION THERAPY, the disclosure of which is incorporated herein by reference. Remote power may instead be worn on the head, on a garment, on the shoulder of a user, or any other suitable position.

In still further examples, a shape memory material such as Nitinol™, or other known shape memory alloy/material, may be used . The two most prevalent shape- memory- alloys are copper-aluminium-nickel, and nickel-titanium (NiTi) alloys, additional compositions with shape memory' characteristics can be had with alloys of zinc, copper, gold and iron, as well as iron or copper based alloys such as Fe-Mn-Si, Cu-Zn-Al and Cu-Al-Ni. Because nitinol contains nickel, which may cause a biological reaction in some users (i.e., nickel allergy), the material may be coated with an inert layer of biocompatible polymer or an extra coating of a biocompatible metal. In one example, a shape memory material is selected such that, when not on the user’s body, the material is elastic, and when placed in contact with the user’s skin, the shape memory material transitions to its“memory” shape and serves to apply radial forces to mechanically hold a device in place about the eye. As will be understood, any of the eyepieces disclosed herein having two or more shape configurations provided by elastic or hinged materials for compression and release can also be provided by shape memory- materials such as Nitinol. If using a shape memory alloy, such as Nitinol™ or other shape memory alloy, in some examples the alloy can be selected and conditioned to have an austenite temperature in the range of about 80 to 100 degrees Fahrenheit, more preferably in the range of about 85 to 95 degrees Fahrenheit. With such a temperature range, the user can reshape the device prior to placement in the eye socket region while the alloy is quite shapeable. On placement in the region of the eye socket, the alloy will be wanned with proximity to the user’s tissue and cross its austenite threshold and create spring tension to hold the eyepiece in position.

Each of these non-limiting examples can stand on its own, or can be combined m various permutations or combinations with one or more of the other examples. The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by w ay of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as“examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein in the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. In this document, the terms“a” or“an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or“one or more.” Moreover, in the following claims, tire terms“first,”“second,” and“third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine- readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, in an example, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, such as during execution or at other times. Examples of these tangible computer-readable media can include, but are not limited to, hard disks, removable magnetic or optical disks, magnetic cassettes, memory cards or sticks, random access memories (RAMs), read only memories (ROMs), and the like.

The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. §1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.

Also, in the above Detailed Description, various features may be grouped together to streamline die disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each oilier in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

The Claimed Invention Is:

1. A wearable therapy apparatus for delivering electrical therapy to the eye of a user comprising:

a frame wearable on the user's head; and

a first electrode coupled to the frame and adapted to deliver current to the user’s conjunctiva.

2. The wearable therapy apparatus of claim 1 further comprising a second electrode coupled to the frame and adapted to deliver current to the user’s conjunctiva associated with the same eye as the first electrode.

3. Tire wearable therapy apparatus of claim 1 further comprising a second electrode coupled to the frame and adapted to deliver current to the user’s conjunctiva associated with the opposite eye as the first electrode.

4. The wearable therapy apparatus of any preceding claim wherein the frame comprises at least a nose rest and an ear rest, and the ear rest is coupled to or comprises a skin electrode to be placed on the skin of the user.

5. The wearable therapy apparatus of any of claims 1-3 wherein the frame comprises at least a nose rest and an ear rest, and the nose rest is coupled to or comprises a skin electrode to be placed on the skin of the user.

6. The wearable therapy apparatus of any preceding claim wherein the frame comprises electronics tor driving a current or applying a voltage through at least the first electrode .

7. The wearable therapy apparatus of any of claims 1 -5 wherein the frame is coupled to a pulse generator comprising electronics tor driving a current through at least the first electrode.

8. The wearable therapy apparatus as in either of claims 6-7 wherein the electronics comprises sensing circuitry and a controller, wherein die controller is configured to deliver therapy by first using the sensing circuitry to determine whether the first electrode is adequately in contact with the conjunctiva of the user to confirm placement, and if placement is confirmed, to then deliver a therapy output via at least the first electrode.

9. Hie wearable therapy apparatus of any preceding claim wherein the first electrode is coupled to the frame by a first section of wire that couples to a contact patch which is adapted for securing to the skin of the user near the user’s eye to hold the first electrode in a desired position.

10. The wearable therapy apparatus of any of claims 1-8 further comprising a pivoting arm coupling the first electrode to the frame and having a first position and a second position, with the pivoting arm shaped so that, when the user is wearing the frame and the pivoting arm is in the first position, the first electrode contacts the conjunctiva, and when the pivoting arm is in the second position, the first electrode does not contact the conj unctiva.

1 1. The wearable therapy apparatus of claim 10 wherein the pivoting arm comprises an electrical switch that opens or closes as the arm is manipulated from the first position to the second position, thereby enabling therapy.

12. A wearable therapy apparatus comprising a neckpiece coupled to at least a first wire, the first wire comprising a first electrode adapted for placement on the conjunctiva of a user, the first wire further comprising a tissue pad adapted to adhere to the skin of the user to be placed near the eye of the patient to hold the first electrode in a desired position, wherein the neckpiece is also a housing containing a pulse generator for issuing therapy pulses to the user when the first electrode is placed on the conjunctiva.

13. A wearable therapy apparatus comprising an earpiece adapted to be worn on the ear of a user and housing a pulse generator for outputting therapy pulses, at least one first wire coupling to a first tissue pad having extending therefrom a first electrode adapted for placement on a conjunctiva of the user, the tissue pad adapted for placement on the forehead of a user so as to hold the first electrode in contact the conjunctiva.

14. A wearable therapy apparatus as m any of claims 1-13 wherein the first electrode comprises a V-shaped element adapted for placement on a canthus of the user.

15. A wearable therapy apparatus as in any of claims 1-13 wherein the first electrode comprises a bar shaped element adapted for placement on a canthus of the user.

16. The apparatus of any of the preceding claims wherein the first electrode comprises a conducti ve contact contained within a contact element that is adapted to hold a conducting fluid therein while placed on the conjunctiva of a user, thereby conducting current from the conductive contact to the user’s conjunctiva.

17. A wearable therapy apparatus as in claim 16 wherein the contact element comprises a wettable polymer.

18. A wearable therapy apparatus as in claim 16 wherein the contact element comprises a cellulose material adapted to soak up and at least partly retain the conductive liquid.

19. A wearable therapy apparatus as in any of claims 16 -18, wherein the contact element is removeable and replaceable relative to the conductive contact.