US-20260124449-A1 - OCULAR THERAPY MODES AND SYSTEMS

US20260124449A1US 20260124449 A1US20260124449 A1US 20260124449A1US-20260124449-A1

Abstract

Methods, systems and apparatuses for delivering electrical or other therapy in the vicinity of the eye. One or more electrodes are positioned on or near the eye, such as contacting the superior or inferior eyelids, on the conjunctiva or medial or lateral canthus, on or inside the nose, or on the forehead. A remote or return electrode is optionally positioned elsewhere on the patient on the torso, neck, back, a limb, an extremity, on the back or side of the head, or near the ear, mandible or temple. A variety of pulse generator positions and support apparatuses are disclosed as well. The pulse generator is used to deliver one or more of therapy or diagnostic electrical pulses to the patient to address a condition of the eye.

Inventors

Paul Rockley
James R. Chiapetta

Assignees

I-LUMEN SCIENTIFIC, INC.

Dates

Publication Date: 20260507
Application Date: 20251230

Claims (20)

1 . An apparatus for treating a condition of the eye of a patient, the apparatus comprising: a lens-less, open spectacles-type frame configured to be worn on a patient's head, the frame having two ear pieces and a nose piece; a pulse generator carried by the frame; a first electrode connected to the frame, operatively connected to the pulse generator, and positioned to contact an area on or near the patient's eye; and a second electrode comprising one or more return electrodes operatively connected to the pulse generator and configured to contact the patient's skin at a location on the patient's body away from the eye; wherein the pulse generator is configured to deliver electrical stimulation between the first and second electrodes.
2 . The apparatus of claim 1 , further comprising a flexible arm or a lead wire that connects the first electrode to the frame, the arm enabling positioning of the first electrode on an eyelid of the patient.
3 . The apparatus of claim 2 , wherein the flexible arm or the lead wire is connected to the frame in a position adjacent to the eye.
4 . The apparatus of claim 1 , further comprising a wire that connects the second electrode to the frame, wherein the second electrode is positioned to contact the patient's skin on the back or side of the patient's neck.
5 . The apparatus of claim 1 , wherein at least one of the first electrode or the second electrode is replaceable and removably attached to the frame.
6 . The apparatus of claim 1 , wherein the control circuitry is further programmed to monitor at least one physiological characteristic of the patient in a vicinity of the first electrode and the second electrode.
7 . The apparatus of claim 6 , wherein the at least one physiological characteristic is selected from the group consisting of: contact impedance between the first electrode and the second electrode, tissue temperatures, and an electrophysiological response to the electrical stimulation.
8 . The apparatus of claim 1 , wherein the pulse generator comprises a microcontroller and a memory storing program instructions, the microcontroller being configured to execute the instructions to control delivery of the electrical stimulation according to a predetermined protocol.
9 . The apparatus of claim 1 , further comprising a third electrode connected to the frame and positioned for placement at the patient's other eye, wherein the pulse generator is configured to deliver electrical stimulation concurrently or alternatingly to both eyes for bilateral treatment.
10 . The apparatus of claim 1 , wherein the pulse generator is configured to deliver the electrical stimulation as a monophasic or biphasic pulse train between the first electrode and the second electrode.
11 . A head-mounted stimulation apparatus for ocular therapy, comprising: a lens-less, open spectacles-type frame, including a nose piece and two ear pieces and is configured to reproducibly locate on a patient's head; a stimulation module housed within the frame, the stimulation module including: a rechargeable battery, a pulse generator having a microcontroller and configured to generate electrical stimulation, and a wireless communication transceiver; an adhesive active electrode patch connected to the frame through a flexible arm or a lead wire and electrically connected to the stimulation module, the active electrode patch being configured to adhere to an external surface of at least one eyelid of the patient when the frame is worn; and wherein the control circuitry is programmed to: measure a contact impedance between the active electrode patch and a return electrode patch comprising one or more return electrodes, and in response to the impedance exceeding a predetermined threshold, inhibit delivery of the electrical stimulation, and deliver selectable monophasic or biphasic pulse trains between the active electrode patch and return electrode patch.
12 . The apparatus of claim 11 , wherein the frame comprises an upper rim and lacks a lower rim, thereby creating an open configuration along a bottom portion of the frame.
13 . The apparatus of claim 11 , wherein the frame comprises a lower rim and lacks an upper rim, thereby creating an open configuration along a top portion of the frame.
14 . The apparatus of claim 11 , wherein the flexible arm or the lead wire is connected to the frame in a position adjacent to the eye.
15 . The apparatus of claim 11 , wherein at least one of the active electrode patch or the return electrode patch is replaceable and removably attached to the frame.
16 . The apparatus of claim 11 , wherein the wireless communication transceiver provides wireless electronic communication including Bluetooth or Wi-Fi with an external host device.
17 . The apparatus of claim 11 , wherein the pulse generator is further configured to deliver the electrical stimulation a monophasic or biphasic pulse train between the first electrode and the second electrode.
18 . The apparatus of claim 11 , further comprising an additional active electrode patch connected to the frame and positioned for placement at the patient's other eye, wherein the pulse generator is configured to deliver electrical stimulation concurrently or alternatingly to both eyes for bilateral treatment.
19 . An apparatus for ocular therapy, the apparatus comprising: a spectacles-type frame that lacks an upper or lower rim, thereby creating an open configuration along a top or bottom or portion of the frame; a stimulation module carried by the frame, the module comprising a rechargeable battery, a wireless communication transceiver, and control circuitry having a pulse generator; a first electrode connected to the frame through a flexible arm or a lead wire and configured to be positioned on or near a patient's eyelid; a second electrode configured to contact the patient's skin at a location on the patient's body away from the eye and be connected to the frame through a wire; wherein the control circuitry is programmed to: measure the electrical impedance of a current path between the first and second electrodes; generate an alert if the measured impedance exceeds a predetermined threshold; and deliver electrical stimulation between the electrodes according to a predetermined therapy protocol.
20 . The apparatus of claim 19 , further comprising: a third electrode connected to the frame through a flexible arm or a lead wire and positioned for placement at the patient's other eye; wherein the pulse generator is configured to deliver the electrical stimulation concurrently or alternatingly to the first and third electrodes for bilateral treatment.

Description

CROSS REFERENCE TO RELATED APPLICATIONS The present application is a continuation of U.S. patent application Ser. No. 18/679,964, filed May 31, 2024, which is a continuation of U.S. patent application Ser. No. 17/626,787, filed Jan. 12, 2022, now U.S. Pat. No. 12,023,498, which is a national stage application of PCT Application No. PCT/US2020/041166, filed Jul. 8, 2020, which claims the benefit of and priority to U.S. Provisional Patent Application No. 62/873,450, filed Jul. 12, 2019, titled OCULAR THERAPY MODES AND SYSTEMS, the disclosures of which are incorporated herein by reference. FIELD The present invention relates generally to the delivery of therapeutic energy for treatment of a variety of conditions. More particularly, the present invention is directed to systems and methods adapted to deliver energy to the eye and/or tissue around the eye. BACKGROUND Therapy to prevent, stop or slow the progression of, or to reverse diseases of the eye is of great interest. As life expectancy expands, more and more of the population is at risk for age related macular degeneration (AMD). Meanwhile, smaller populations of patients suffer from a variety of maladies, including Stargardt's 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 interfaces 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, microcurrent therapy or millicurrent therapy, without intending to limit the scope of the invention to a particular range of current with such terms. New and alternative approaches to therapy delivery for targets in and around the eye are desired. A first illustrative and non-limiting example takes the form of an apparatus for treating a condition of the eye comprising a pulse generator coupled to a plurality of electrodes, the pulse generator comprising circuitry including a controller configured to perform a method of treating an eye condition by delivery of therapy between at least first and second electrodes. Additionally or alternatively, the apparatus may further comprise a headband that holds the pulse generator. In another alternative, the headband further holds the first and second electrodes in desired positions on the forehead of the patient. Additionally or alternatively, the apparatus may further comprise an earpiece adapted to couple onto the ear of the patient, the pulse generator being carried by the earpiece. Additionally or alternatively, the apparatus may further comprise an armband adapted to be carried on an arm of the patient, the pulse generator being carried by the armband. Additionally or alternatively, the apparatus may further comprise a neckpiece adapted to be worn on the neck of the patient, the pulse generator being carried by the neckpiece. Additionally or alternatively, the apparatus may further comprise a frame having an earpiece and a noserest, the pulse generator being carried by the frame. Additionally or alternatively, the apparatus may further comprise a harness wearable on the torso of the patient, pulse generator being carried by the harness. Additionally or alternatively, the apparatus may further comprise a third electrode, wherein the controller is further configured to deliver therapy in a spatial pattern using the first second and third electrodes to issue therapy with at least first and second steps, wherein utilization of the first, second and third electrodes varies from the first to the second step. Additionally or alternatively, the utilization varies as follows: in the first stage, first total current is issued by the first and second electrodes to the third electrode, with the first electrode issuing a first percentage of the first total current and the second electrode issuing a second percentage of the first total current; and in the second stage, second total cur