System and method for medical device

Abstract

To provide a cable-holder system for physically supporting connections to a medical device used on a patient.SOLUTION: There is provided a cable-holder system, the system including a first portion configured to be supported at the patient's head 99; a second portion movably coupled to the first portion; and an electrical connector configured to electrically connect to the medical device, where the electrical connector is physically connected to the second portion.SELECTED DRAWING: Figure 19A

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This international application claims priority to U.S. Design Patent Application No. 29 / 754,410, entitled "MEDICAL DEVICE," filed on October 9, 2020 by Marshall T. Masko et al., and U.S. Utility Patent Application No. 17 / 180,669, entitled "SYSTEM AND METHOD FOR A MEDICAL DEVICE," filed on February 19, 2021 by Marshall T. Masako et al., each of which is incorporated herein by reference in its entirety.

[0002] This application is U.S. Patent No. 10,391,312, entitled “APPARATUS AND METHOD FOR OCULAR MICROCURRENT STIMULATION THERAPY,” issued on August 27, 2019 to Blair P. Mowery et al.; PCT Application No. PCT / US2016 / 051550, entitled “APPARATUS AND METHOD FOR OCULAR MICROCURRENT STIMULATION THERAPY,” filed on September 13, 2016 (International Publication No. WO2017 / 048731); PCT Application No. PCT / US2019 / 063404 (International Publication No. WO2020 / 131329), entitled “APPARATUS AND METHOD FOR MICROCURRENT STIMULATION THERAPY,” filed on November 26, 2019 by Marshall T. Masko et al.; PCT Application No. PCT / US2019 / 067627 (International Publication No. WO 2020 / 132337), entitled “MICROCURRENT-STIMULATION-THERAPY APPARATUS AND METHOD,” filed on December 19, 2019 by Marshall T. Masko et al.; PCT Application No. PCT / US2020 / 021267 (International Publication No. WO 2021 / 177968), entitled “VISION TESTING AND TREATMENT SYSTEM AND METHOD,” filed on March 5, 2020 by Marshall T. Masko et al.; U.S. Provisional Patent Application No. 62 / 283,870, entitled “APPLIANCE FOR MICROCURRENT STIMULATION THERAPY USING A DISPOSABLE MATERIAL AFIXED TO THE UPPER AND LOWER, EYE LID & OTHER BODY PARTS,” filed on September 15, 2015 by Mowery et al.; U.S. Provisional Patent Application No. 62 / 283,871, entitled “APPARATUS FOR A METHOD OF APPLICATION OF MICROCURRENT STIMULATION THERAPY, CONSISTING OF A GOGGLE DEVICE AFFIXED TO & ENCIRCLING THE UPPER AND / OR LOWER EYELIDS, AS WELL AS OTHER BODY PARTS,” filed on September 15, 2015 by Masko et al.; U.S. Provisional Patent Application No. 62 / 365,838, entitled “APPLIANCE FOR MICRO-CURRENT STIMULATION,” filed on July 22, 2016 by Tapp et al.; U.S. Provisional Patent Application No. 62 / 783,116, entitled “APPARATUS AND METHOD FOR MICROCURRENT STIMULATION THERAPY,” filed on December 20, 2018 by Masko et al. This is a related application to U.S. Provisional Patent Application No. 63 / 025,987, entitled “ELECTRODE SYSTEM FOR VISION TREATMENT AND METHOD,” filed May 15, 2020 by Duncan et al., each of which is incorporated by reference in its entirety. [Background technology]

[0003] No. 4,018,218, entitled "Method and Apparatus for Sleep Induction," issued to Carlson et al. on April 19, 1977, is incorporated herein by reference. U.S. Pat. No. 4,018,218 describes an apparatus and method for inducing sleep that utilizes an oscillator to control the frequency of electrical stimulation received by the patient. First and second multivibrators generate the signals necessary to stimulate the central nervous system through conduction down the optic nerve and stimulate the retina of the eye to produce a visual aura. An amplifier amplifies the signal generated by the multivibrator, and the electrodes transmit the amplified signal to the patient. The various components of the apparatus may be housed within an eye frame structure, with the eyelid electrode pads held in place along the patient's eyes and the mastoid electrode pads held in place by ear hooks on the frame.

[0004] U.S. Patent No. 5,522,864, entitled "Apparatus and method for ocular treatment," issued to Wallace et al. on June 4, 1996, is incorporated herein by reference. U.S. Patent No. 5,522,864 describes that macular degeneration and other ocular conditions in a subject are treated by electrically contacting the positive electrode of a direct current power source to the closed eyelid of the subject, electrically contacting the negative electrode of the direct current power source to the back of the neck of the subject, and passing a single constant direct current of 200 μA between the two electrodes through the subject for about 10 minutes. The power source can be a portable, battery-powered constant current direct current generator that is attached to the subject. The subject can be mobile during treatment.

[0005] U.S. Patent No. 6,035,236, entitled "Methods and apparatus for electrical microcurrent stimulation therapy," issued to Jarding et al. on March 7, 2000, is incorporated herein by reference. Patent No. 6,035,236 describes an apparatus for providing an electrical signal to a body part to administer microcurrent stimulation therapy to the body part. The apparatus preferably includes a first sweep wave or sweep frequency signal generator configured to generate a first sweep wave signal, and a buffer amplifier circuit configured to receive the first sweep wave signal from the first sweep wave signal generator, amplify and buffer the sweep wave signal to create a buffered sweep wave signal. Additionally, the apparatus preferably includes a current limiting circuit configured to receive the buffered sweep wave signal from the buffer amplifier circuit and limit the amount of current provided to the body part. Finally, the apparatus preferably includes a probe for applying the sweep wave signal to the body part. The apparatus may further comprise a second signal generator for generating a second signal, which may comprise either a swept wave signal or a non-swept wave signal. The apparatus will also comprise a signal combining circuit configured to receive the first and second signals from the first and second signal generators and to combine the first and second signals into a composite swept wave signal.

[0006] U.S. Patent No. 6,275,735, entitled "Methods and apparatus for electrical microcurrent stimulation therapy," issued to Jarding et al. on August 14, 2001, is incorporated herein by reference. Patent No. 6,275,735 discloses a method and apparatus for administering microcurrent stimulation therapy to a body part. In one embodiment, the method allows digital control of the modulation frequency of the microcurrent signal. The method includes receiving a first digital data word that is used to generate a first frequency that correlates to the first digital data word, after which a first microcurrent signal of the first frequency is applied to the body part. A second digital data word is received and used to generate a second frequency that correlates to the second digital data word. A second microcurrent signal of the second frequency is applied to the body part. In another embodiment, the method allows direct digital synthesis of the microcurrent stimulation signal. The first digital data word is used to generate a first analog voltage that is applied to the body part. The second digital data word is used to generate a second analog voltage that is also applied to the body site, where the first analog voltage is different from the second analog voltage. In yet another embodiment, an apparatus for administering microcurrent stimulation therapy comprises a digital-to-analog converter, a controller, and a plurality of data words. The controller is coupled to the digital-to-analog converter and provides the digital data words to the digital-to-analog converter to generate an electrical signal for microcurrent stimulation therapy.

[0007] U.S. Patent No. 6,445,955, entitled "Miniature wireless transcutaneous electrical nerve or muscular-stimulation unit," issued to Michelson et al. on September 3, 2002, is incorporated herein by reference. U.S. Patent No. 6,445,955 describes a miniature wireless transcutaneous nerve or muscle electrical stimulation unit. The unit has a housing attached to a number of electrodes. An electronic module containing electrical circuitry is housed within the housing and delivers a series of monophasic or biphasic pulses to the patient's pain site via the electrodes. The electrodes are disposable and may come in a variety of shapes and sizes. The patient may select and control the intensity and frequency of the pulses, as well as the orientation and number of electrodes, by selecting one of several TENS and microcurrent waveforms. Means for powering the electronic module may be integrated into the electrodes in one disposable, removable assembly. A wearable remote control sends a transmission signal to a receiver in the electronic module, allowing the patient to program a particular unit placed on the body to operate with a specified series of waveforms. The electrodes may be embedded in splints, bandages, braces, and casts, where wires or flexible circuitry connect the electrodes to the unit. The electrodes may be arranged in a grid so that a specific firing sequence can be programmed to provide a more therapeutic effect on the pain site, or may be embedded in an adhesive strip, similar to a traditional "Band-Aid."

[0008] U.S. Patent No. 6,636,754, entitled "Apparatus and method for determining cardiac output in a living subject," issued to Baura et al. on Oct. 21, 2003, is incorporated herein by reference. Patent No. 6,636,754 describes an improved apparatus and method for determining cardiac output in a living subject. The improved apparatus of the invention generally comprises one or more electrode assemblies, or patches, that are applied to the skin adjacent the subject's thoracic cavity. The terminals of each electrode patch contact an electrolytic gel and are spaced apart from one another within the patch at a predetermined distance. This predetermined spacing allows for more stable measurements in a clinical environment and also allows for detection of a lack of electrical continuity between the patch terminals and their associated electrical connectors. The method generally includes generating and passing a stimulation current through the terminals and the subject's thoracic cavity and measuring impedance as a function of time. The impedance is used to determine myocardial output, which is then used along with the subject's heart rate (also sensed via the electrode patch) to determine cardiac output. A method for detecting a lack of electrical continuity at one or more terminals of an electrode patch is also disclosed.

[0009] U.S. Patent No. 7,062,319, entitled "Method and arrangement for determining suitable treatment frequency and / or intensity" issued to Ihme et al. on June 13, 2006, is incorporated herein by reference. Patent No. 7,062,319 describes a method and apparatus for determining a suitable treatment frequency and / or intensity of a treatment signal used in electrical therapy. In the method, when a stimulating electrical signal is sent to a subject, different intensities of the stimulating electrical signal generate different response types in the subject. For at least three different response types, the intensities of the stimulating electrical signal at which the response types are generated are stored. The stored electrical signal intensities for the different response types at at least three different frequencies are compared with reference values, and frequencies and / or signal intensities that deviate sufficiently from one or more reference values ​​are determined. The method uses the frequencies and / or signal intensities obtained in the process when determining a suitable treatment frequency and / or signal intensity.

[0010] U.S. Patent No. 7,158,834, entitled "Method and apparatus for performing microcurrent stimulation (MSC) therapy," issued to Paul, Jr. on January 2, 2007, is incorporated herein by reference. Patent No. 7,158,834 describes a method and apparatus for performing microcurrent stimulation (MSC) therapy. Patent No. 7,158,834 states that application of a microcurrent signal of a specific frequency to the eye for a specific period of time has been found to stabilize or even improve the condition of macular degeneration and other eye diseases.

[0011] U.S. Patent No. 7,215,989, entitled "Multiple electrode assembly," issued to Burks on May 8, 2007, is incorporated herein by reference. Patent No. 7,215,989 describes a multiple electrode assembly that provides electrical connection between a patient's body and a monitoring device. With multiple electrode assemblies, only half the number of assemblies are required to connect a patient to multiple devices compared to conventional single electrode assemblies. It takes less time to connect a patient to a monitoring device, and fewer assemblies are connected to the patient, which reduces discomfort. Fewer assemblies to deploy also reduces costs. The assemblies can be in many different shapes and lead attachment configurations to accommodate a wide range of monitoring functions.

[0012] U.S. Patent No. 7,326,181, entitled "Nervous tissue stimulation device and method," issued to Katims on February 5, 2008, is incorporated herein by reference. Patent No. 7,326,181 describes a method using precisely controlled computer programmable stimulation for neural selective tissue stimulation that does not leave sufficient voltage or electrical artifacts in the stimulated tissue to interfere with or obscure the recording of physiological responses used by a monitoring system to assess the physiological conductivity of the tissue under study. The computer controls both the waveform, duration, and intensity of the stimulation. Output triggers to the neural response recording component control the timing of the actions. Neuroselective neural tissue response latency and amplitude can be determined. Computer controlled stimulation can also be administered for therapeutic purposes.

[0013] U.S. Patent No. 8,116,841, entitled "Adherent device with multiple physiological sensors," issued to Bly et al. on February 14, 2012, is incorporated herein by reference. Patent No. 8,116,841 describes an adhesive device for long-term monitoring of a patient comprising a breathable tape. The breathable tape includes a porous material coated with an adhesive for adhering the breathable tape to the patient's skin. At least one electrode is affixed to the breathable tape and can be electrically coupled to the patient's skin. A printed circuit board is connected to the breathable tape for supporting the printed circuit board with the breathable tape when the tape is adhered to the patient. An electronic component is electrically connected to the printed circuit board and coupled to the at least one electrode for measuring a physiological signal of the patient. A breathable cover and / or electronics housing is disposed over the circuit board and electronic component and connected to at least one of the electronic component, the printed circuit board, or the breathable tape.

[0014] U.S. Patent No. 8,731,657, entitled “Multi-mode microcurrent stimulus system with safety circuitry and related methods,” issued to Shambayati et al. on May 20, 2014, is incorporated herein by reference. Patent No. 8,731,657 describes a microcurrent stimulation device that includes a power source, two or more electrodes electronically coupled to the power source, a microcontroller configured to generate an electromagnetic waveform, and an impedance measurement module configured to measure the electrical impedance of one or more biological tissues between the two or more electrodes. A first safety circuit monitors current flow through one or more components of the microcurrent stimulation device and interrupts the current flow when the current through the one or more components exceeds a predetermined amount. A second safety circuit interrupts current flow through the one or more components when a firmware failure occurs.

[0015] U.S. Patent No. 9,283,371, entitled "Electro-stimulation system," issued to Thu-Ha Duncan on March 15, 2016, and is incorporated herein by reference. Patent No. 9,283,371 describes an electrical stimulation system with a miniature power supply and control assembly, and multiple molded gel electrode patches with instructions to facilitate administration of therapy by the user.

[0016] U.S. Patent Publication No. 2005 / 0137649, entitled "Method and apparatus for performing microcurrent stimulation (MSC) therapy" by Paul, Jr., published June 23, 2005, is incorporated herein by reference. Patent Publication No. 2005 / 0137649 describes a method and apparatus for administering microcurrent stimulation (MCS) therapy and asserts that "application of microcurrent signals of specific frequencies to the eye for specific durations has been found to stabilize and even improve the pathology of macular degeneration and other eye diseases, and experimental data from clinical trials indicates that the treatment is safe and effective, with outcomes in treated individuals being at least superior to placebo." Patent Publication No. 2005 / 0137649 continues, "Experimental data from clinical trials indicates that approximately 98% of patients who received the MCS treatment of the invention experienced stabilization or improvement in their macular degeneration within one year of initiating treatment." Of this percentage, approximately 65% ​​of MCS-treated patients experience improvement in vision, while approximately 32% experience stabilization of their macular degeneration (without further loss of vision).

[0017] U.S. Patent Publication No. 2008 / 0171929, entitled "Method for standardizing spacing between electrodes, and medical tape electrodes" by Katims, published July 17, 2008, is incorporated herein by reference. Patent Publication No. 2008 / 0171929 describes maintaining standardization between electrode pairs in medical devices without the need for a Mylar spreader, such as by forming the electrode pairs integrally with the tape portion. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 is a perspective view of a decorative medical device. [Diagram 2] FIG. 1 is a top view of a decorative medical device. [Diagram 3] FIG. 13 is a bottom view of a decorative medical device. [Figure 4] FIG. 13 is a left side view of a decorative medical device. [Diagram 5] FIG. 13 is a right side view of the decorative medical device. [Figure 6] FIG. 1 is a front view of a decorative medical device. [Figure 7] FIG. 13 is a rear view of a decorative medical device. [Figure 8] FIG. 1 is a perspective view of a medical device assembly. [Figure 9] FIG. 1 is a top view of a medical device assembly. [Figure 10] FIG. 2 is a bottom view of the medical device assembly. [Figure 11] FIG. 2 is a left side view of the medical device assembly. [Figure 12] FIG. 13 is a right side view of the medical device assembly. [Figure 13] FIG. 2 is a front view of a medical device assembly. [Figure 14] FIG. 2 is a rear view of the medical device assembly. [Figure 15A]FIG. 15 is a perspective view of a cable holder system (1501) according to some embodiments of the present invention. [Figure 15B] FIG. 1 is a perspective view of a stimulation therapy system (1502) according to some embodiments of the present invention. [Figure 15C] FIG. 15 is a perspective view of a cable holder system (1503) according to some embodiments of the present invention. [Figure 16A-1] FIG. 16 is a perspective view of a cable holder system (1601) according to some embodiments of the present invention. [Figure 16A-2] FIG. 1 is an oblique view of a cable holder system (1601) showing movable portion (1620) rotated so that electrical connection portion (1627) is fully extended away from the cable holder system (1601), according to some embodiments of the present invention. [Figure 16B] FIG. 16 is a perspective view of a stimulation therapy system (1602) according to some embodiments of the present invention. [Figure 17A] FIG. 17 is a perspective view of a cable holder system (1701) according to some embodiments of the present invention. [Figure 17B] FIG. 17 is a perspective view of a stimulation therapy system (1702) according to some embodiments of the present invention. [Figure 18A] FIG. 1 is a schematic front view of a treatment device system (1801) having two substrates (1850) positioned around the left and right eyes of a human (99), respectively, according to some embodiments of the present invention. [Figure 18B] FIG. 1 is a front view of a system (1802) showing a therapeutic device substrate (1850) positioned about a human eye (98), according to some embodiments of the present invention. [Figure 19A] FIG. 1 is a schematic front view of a treatment device system (1901) having two substrates (1950) positioned around the left and right eyes, respectively, of a human (99), according to some embodiments of the present invention. [Figure 19B] FIG. 1 is a front view of a system (1902) showing a therapeutic device substrate (1950) positioned around a human eye (98), according to some embodiments of the present invention. [Figure 20]FIG. 1 is a first perspective view of a medical device apparatus (2001). [Figure 21] A second perspective view of the device (2001) showing the device in the "rotated" position. [Figure 22] FIG. 2 is a top view of the device (2001). [Figure 23] FIG. 2 is a bottom view of the device (2001). [Figure 24] FIG. 2 is a left side view of the device (2001). [Diagram 25] FIG. 2 is a right side view of the device (2001). [Figure 26] FIG. 2 is a front view of the device (2001). [Figure 27] FIG. 2 is a rear view of the device (2001). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Although the following detailed description includes many specific details for purposes of illustration, those skilled in the art will appreciate that many variations and modifications to the following details are within the scope of the present invention. Although specific examples are used to illustrate certain embodiments, the claimed invention is not intended to be limited to only these specific examples, but rather to include the full scope of the appended claims. Accordingly, the following preferred embodiments of the present invention are described without any loss of generality to, and without imposing limitations on, the claimed invention. Furthermore, in the following detailed description of the preferred embodiments, reference is made to the accompanying drawings, which form a part of the description, and which show, by way of illustration, specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be used and structural changes may be made without departing from the scope of the present invention. The embodiments shown in the figures and described herein may include features not included in all specific embodiments. A specific embodiment may include only a subset of all of the described features, or a specific embodiment may include all of the described features.

[0020] The first digit of a reference number appearing in the figures generally corresponds to the number of the figure in which the element is first introduced, and the same reference number is used throughout to refer to the same element appearing in multiple figures. Signals and connections may also be referred to by the same reference number or label, with the actual meaning becoming clear from use in the context of the description.

[0021] FIG. 1 is a perspective view of a decorated medical device.

[0022] FIG. 2 is a top view of a decorated medical device.

[0023] FIG. 3 is a bottom view of the decorated medical device.

[0024] FIG. 4 is a left side view of the decorated medical device.

[0025] FIG. 5 is a right side view of the decorated medical device.

[0026] FIG. 6 is a front view of a decorated medical device.

[0027] FIG. 7 is a rear view of the decorated medical device.

[0028] FIG. 8 is a perspective view of a medical device assembly.

[0029] FIG. 9 is a top view of a medical device assembly.

[0030] FIG. 10 is a bottom view of the medical device assembly.

[0031] FIG. 11 is a left side view of the medical device assembly.

[0032] FIG. 12 is a right side view of the medical device assembly.

[0033] FIG. 13 is a front view of the medical device assembly.

[0034] FIG. 14 is a rear view of the medical device assembly.

[0035] 15A is a perspective view of a cable holder system (1501) according to some embodiments of the present invention. In some embodiments, the cable holder system (1501) comprises a base (1510) configured to fit around a patient's ear and a movable part (1520) (sometimes referred to herein as a "sliding part") coupled to the base (1510) at a "top" of the base (i.e., the portion of the base (1510) that is located near the top of the ear when the base (1510) is in place on the patient). In some embodiments, the slide (1520) comprises an electrical connector (1525) configured to electrically couple to one or more stimulation devices located on the patient (e.g., electrodes, light emitters, magnetic pulse sources, and / or heat sources located around the patient's eyes). In some embodiments, the slide (1520) fits within the hollow portion (1511) of the base (1510) such that it can be moved to multiple horizontal positions relative to the base (1510) to provide a patient head size adjustment mechanism. In some such embodiments, the desired horizontal position of the slide (1520) is selected based on the distance between the electrical connector (1525) and the electrical connection of the patient stimulation device, thereby allowing the cable holder system (1501) to accommodate multiple patient head sizes. In some embodiments, the slide (1520) comprises a flange (1521) that prevents the slide (1520) from being completely pulled through the hollow portion (1511) of the base (1510). In some embodiments, the base (1510) and the slide (1520) are fabricated from a polymer (e.g., an injection molded polymer, a 3D printed polymer, etc.), a metal, carbon fiber, and / or any other suitable material. In some embodiments, the cable holder system (1501) is reusable across multiple treatment sessions, for example, in some embodiments, the cable holder system (1501) is covered with a disinfecting film that is discarded after each use.

[0036] In some embodiments, the electrical connector (1525) is electrically coupled to a cable / electrical conduit (1531) that exits the slider (1520) near the flange (1521) and enters into the body of the base (1510). In some embodiments, the base (1510) comprises cable exits (1512) and (1513). In some embodiments, the cables / wires (1532) and (1533) exit the base (1510) via cable exits (1512) and (1513), respectively. In some embodiments, the cables / wires (1532) and (1533) provide electrical connections to a ground electrode, a second cable holder system (1501) located on the patient's other ear, and / or other electronic devices associated with the stimulation therapy system, such as a therapy controller. In some embodiments, the therapy controller is affixed to the patient's temple and operably coupled to the stimulation device on a first side of the therapy controller and to a cable holder system (1501) on a second side of the therapy controller. In some embodiments, the therapy controller is housed within the base (1510) (or affixed to the exterior of the base (1510)) and the cable holder system (1501) provides a device that physically supports the connection between the stimulation device located on the patient and the therapy controller (in some such embodiments, the cable holder system (1501) includes the therapy controller within the base (1510) and the therapy controller is operably coupled (via electrical connections (1525) and cables / wires (1531), (1532), and / or (1533)) to one or more electrode stimulation devices located around the patient's eyes and one or more ground electrodes located on the patient's head).

[0037] In some embodiments, the cable holder system (1501) (and / or a therapy control device located in or on the cable holder system (1501)) comprises wireless communication electronics that enable the system (1501) to communicate wirelessly with other systems (1501), such as a mobile device (e.g., a smartphone), a base station (e.g., a laptop computer), and / or a second system (1501) located on the patient's other ear. In some such embodiments, the system (1501) is configured to communicate wirelessly using Bluetooth, Near Field Communication (NFC), a cellular network (e.g., Global System for Mobile Communications (GSM)), Wi-Fi, and / or any other suitable wireless communication protocol / standard. In some embodiments, a system (1501) is located on each ear of the patient, respectively, and is operably coupled to a corresponding ocular stimulation device, and each of the systems (1501) communicates with each other (wirelessly or via a wired connection) to provide sequential or simultaneous ocular stimulation to the patient.

[0038] In some embodiments, the cable holder system (1501) (and / or a therapy controller located in or on the cable holder system (1501)) provides a touch pad or touch screen that allows a patient or other person (e.g., a medical professional) to adjust the stimulation level provided by a stimulation device operably coupled to the system (1501). In some embodiments, the system (1501) and / or a therapy controller coupled to the system (1501) also includes audio electronics and lights configured to provide audio / visual cues to indicate the progress and / or status of the stimulation therapy provided by a stimulation device operably coupled to the system (1501).

[0039] FIG. 15B is a perspective view of a stimulation therapy system (1502) according to some embodiments of the present invention. In some embodiments, the slide (1520) of the system (1502) is coupled via an electrical connector (1557) to an electrical conductor (1554), which is operably coupled to an eye stimulation device (1550) (e.g., in some embodiments, the eye stimulation device (1550) includes one or more stimulation electrodes configured to provide a therapeutic level of electrical stimulation to an eye of the patient (99)). In some embodiments, the system (1502) is also operably coupled to one or more ground electrodes (1541) located on the back of the patient's (99) head (in some embodiments, the ground electrode (1541) is placed against the skin on the patient's (99) neck, and in some embodiments, the ground electrode (1541) is placed against the skin of any other suitable location of the patient (99)). In some embodiments, the mating system of system (1502) is located on the opposite side of the patient (99) and is configured to communicate (wirelessly or via a wired connection) with system (1502). In some embodiments, system (1502) and its mating system on the opposite side of the patient (99) each include a respective therapy controller coupled to a respective cable holder system (1501) (in some such embodiments, each therapy controller is housed within a respective cable holder system (1501)). In other embodiments, system (1502) and its mating system are controlled by a single therapy controller coupled to one of the respective cable holder systems (1501).

[0040] FIG. 15C is a perspective view of a cable holder system (1503) according to some embodiments of the present invention. In some embodiments, the system (1503) is substantially similar to the system (1501), except that the base (1516) includes a top (1517) over which the slide (1526) slides (in the direction of the arrow (1599)) rather than the slide moving through a hollow portion of the base as shown in FIG. 15A. In some embodiments, the slide (1526) includes an extension (1534) having an electrical connection (1527) (e.g., a USB connector or other suitable electrical connector) configured to electrically couple to one or more stimulation devices (e.g., electrodes, light emitters, magnetic pulse sources, and / or heat sources located around the patient's eye) located on the patient. In some embodiments (not shown), the electrical connection (1527) is directly coupled to the slide (1526) and the extension (1534) is not present.

[0041] 16A-1 is a perspective view of a cable holder system (1601) according to some embodiments of the present invention. In some embodiments, the cable holder system (1601) is similar to the cable holder system (1501), except that the patient head size adjustment mechanism on the system (1601) involves a rotational motion rather than a water-smooth motion. In some embodiments, the cable holder system (1601) comprises a base (1610) coupled to the cables / wires (1632) and (1633) and configured to fit around the patient's ears, a movable part (1620) coupled to a flexible extension (1634) having an electrical connection (1627) (e.g., a USB connection or other suitable electrical connection), and a rotation mechanism (1611) operably coupled to the base (1610) and the movable part (1620) (e.g., in some embodiments, a pin forming a pivot point between the base (1610) and the movable part (1620)). In some embodiments (not shown), the electrical connection (1627) is directly coupled to the movable portion (1620) and there is no flexible extension (1634). In some embodiments, the distance between the electrical connection (1627) and the electrical connection of the patient stimulation device is adjusted by rotating the movable portion (1620) about the rotation mechanism (1611) such that the movable portion (1620) moves in the direction of the arrow (1699) and the electrical connection (1627) moves closer or farther from the patient stimulation device.

[0042] FIG. 16A-2 is a perspective view of the cable holder system (1601) showing the movable part (1620) rotated so that the cable / wire (1631) is fully extended away from the system (1601) in some embodiments of the present invention.

[0043] 16B is a perspective view of a stimulation therapy system (1602) according to some embodiments of the present invention. In some embodiments, the system (1602) is substantially similar to the system (1502) of FIG. 15B, except that the cable holder system (1501) is replaced with a cable holder system (1601).

[0044] 17A is a perspective view of a cable holder system (1701) according to some embodiments of the present invention. In some embodiments, the system (1701) is substantially similar to the system (1501) of FIG. 15A, except that the base (1510) is replaced with a head connector (1710) configured to be positioned at least partially around the patient's head, rather than being positioned at least partially around the patient's ear.

[0045] 17B is a perspective view of a stimulation therapy system (1502) according to some embodiments of the present invention. In some embodiments, the head connector (1710) comprises a strap or band that fits around the top of the patient's head such that the sliders (1520) are respectively coupled to each end of the head connector (1710) just above the corresponding ears of the patient (99). In some embodiments, the head connector is configured to fit tightly around the patient's head such that the cable holder system (1701) is held in place during use.

[0046] 18A is a schematic front view of a treatment device system (1801) having two substrates (1850) positioned around the left and right eyes of a human (99), respectively, according to some embodiments of the present invention, showing exemplary locations of electrodes (1851), ring electrodes (1852), and connections to a treatment control device (1890). In some embodiments, each substrate (1850) fits within each eye socket and overlies an outer portion of the eye. In some embodiments, for each substrate (1850), each electrode (1851) of the plurality of individually actuatable electrodes (1851) is coated with a conductive gel and encased in an electrically insulating adhesive. As a result, when an electrical signal is applied to a first selected electrode (1851), if a signal from the therapy controller (1890) is active to the first electrode (and one or more other electrodes (1851) if the one or more other electrodes (1851) are also activated at the time), current enters the tissue of the patient (99) only under that first electrode (and, in some embodiments, said one or more other electrodes (1851)). In some embodiments, the area of ​​tissue under each of the plurality of electrodes (1851) is approximately 1 mm 2 ~ approx. 50mm 2 (For example, each electrode has a square electrical contact to the skin measuring about 1 mm x 1 mm to about 7 mm x 7 mm, or a circle having a diameter of about 1.125 mm to about 8 mm.) In some embodiments, the area of ​​tissue under each of the plurality of electrodes (1851) is any other suitable size.

[0047] In some embodiments, each treatment device substrate (1850) includes electrical conductors (1854) electrically coupled to a treatment controller (1890). In some embodiments, the treatment controller (1890) is located locally (e.g., in a battery-powered unit carried by the person (99), such as in a shirt pocket or in an elastic band attached to the head, or in or on a cable holder, such as the cable holder system (1501) of FIGS. 15A-15B), while in other embodiments, the treatment controller (1890) is attached to or is part of a computer-controlled device, such as a laptop personal computer, tablet computer, or desktop computer. Treatment signals from the treatment controller (1890) are carried by connecting wire bundles (1854) to the electrodes (1851), which apply a current load to the patient's tissue.

[0048] In some embodiments, the system (1801) comprises one or more electrodes (1841) that are placed in contact with the skin of the patient (99) (e.g., in some embodiments, one or more electrodes (1841) are placed in contact with the skin at the back of the patient's (99) head, in some embodiments, one or more electrodes (1841) are placed in contact with the skin at the neck of the patient (99), and in some embodiments, one or more electrodes (1841) are placed in contact with the skin at any other suitable location of the patient (99)) and is attached to the body device (treatment control device (1890)) by electrical conductors (1842) (e.g., in some embodiments, wires). In some embodiments, treatment electrical stimulation pulses are applied to electrodes (1851) and / or ring electrodes (1852) on a treatment substrate (1850) surrounding each eye, and a return path (i.e., a ground signal) is provided via the electrodes (1841).

[0049] 18B is a front view of a system (1802) showing a therapy device substrate (1850) positioned about a human eye (98) according to some embodiments of the present invention, illustrating exemplary locations of electrodes and connections to a therapy controller (1890). In some embodiments, the therapy controller (1890) includes a battery-powered microprocessor (μP) and is optionally controlled and / or programmed by a nearby laptop personal computer, tablet computer, desktop computer, or the like. In some embodiments, the substrate (1850) includes electrical conductors (1854) electrically coupled to an electrical connector (1857) that plugs into or otherwise electrically connects to a corresponding connector (1825) on the therapy controller (1890).

[0050] In some embodiments, the ring electrode (1852), when activated by the therapy controller (1890), provides electrical stimulation that occurs around the entire circumference of the ring electrode (1852) such that the entire circumference of the eye (98) receives electrical stimulation. In other embodiments, the ring electrode (1852) is configured to provide electrical stimulation only at selected locations along the circumference of the ring electrode (1852). In some embodiments, during a therapy session provided to the eye (98), a first level of stimulation is provided by the ring electrode (1852) and at least a second level of stimulation is provided at one or more selected electrodes (1851) located at one or more different locations around the eye (98) (in some such embodiments, the first level of stimulation provided by the ring electrode (1852) is provided simultaneously with the second level of stimulation provided by the one or more selected electrodes (1851). In other such embodiments, the second level of stimulation provided by the one or more selected electrodes (1851) occurs subsequent to the first level of stimulation provided by the ring electrode (1852). In some embodiments, the first level of stimulation acts as a sub-threshold stimulation to prime the eye (98) such that actual electrical stimulation occurs to the eye (98) only when one or more selected electrodes (1851) deliver their electrical signals to the eye (98). In some embodiments, the ring electrode (1852) and the one or more electrodes (1851) each provide the same level of electrical stimulation. In some embodiments, the electrodes (1851) are individually actuatable such that each electrode (1851) is capable of providing a different, selectable level of stimulation.

[0051] FIG. 19A is a schematic front view of a therapy device system (1901) having two substrates (1950) positioned around the left and right eyes of a person (99), respectively, according to some embodiments of the present invention, showing a ring electrode (1952) and a connection to a therapy controller (1890). In some embodiments, the ring electrode (1952) provides electrical stimulation that occurs around the entire circumference of the ring electrode (1952) such that the entire circumference of the eye (98) receives electrical stimulation when activated by the therapy controller (1890). In other embodiments, the ring electrode (1952) is configured to provide electrical stimulation only at a selected location or selected locations along the circumference of the ring electrode (1952). Various other reference numbers in FIG. 19A are as described above with respect to FIG. 18A.

[0052] Figure 19B is a front view of a system (1902) showing a treatment device substrate (1950) positioned about a human eye (98), showing ring electrodes (1952) and connections to a treatment control device (1890), according to some embodiments of the present invention. Various other reference numerals in Figure 19B are as described above with respect to Figure 18B.

[0053] 20 is a first perspective view of a medical device apparatus (2001). In some embodiments, the apparatus (2001) is functionally similar to the cable holder system (1601), except that the apparatus (2001) does not include a flexible extension (1634).

[0054] FIG. 21 is a second perspective view of the device (2001) showing the device in the "rotated" position.

[0055] FIG. 22 is a top view of the device (2001).

[0056] FIG. 23 is a bottom view of the device (2001).

[0057] FIG. 24 is a left side view of the device (2001).

[0058] FIG. 25 is a right side view of the device (2001).

[0059] FIG. 26 is a front view of the device (2001).

[0060] FIG. 27 is a rear view of the device (2001).

[0061] In some embodiments, the present invention provides a cable holder system for physically supporting a connection to a medical device for use on a patient, the system comprising a first portion configured to be supported on the patient's head, a second portion movably coupled to the first portion, and an electrical connector configured to electrically connect to the medical device, the electrical connector being physically connected to the second portion. In some embodiments of the system, the first portion is configured to fit at least partially around a first ear of the patient. In some embodiments, the first portion is configured to be supported by the first ear of the patient. In some embodiments, the first portion is configured to at least partially cover the patient's head. In some embodiments, the first portion is configured to extend across the top of the patient's head.

[0062] In some embodiments of the system, the second portion is configured to adjustably slide between a plurality of horizontal positions relative to the first portion, each of the plurality of horizontal positions being located at a respective distance from the medical device. In some embodiments, the second portion comprises a rotation mechanism (e.g., a hinge) such that the second portion can be rotated relative to the first portion to change the distance between the electrical connector and the medical device. In some embodiments, the system further comprises a medical device, the medical device comprising a plurality of electrodes configured to apply electrical stimulation to the patient and a therapy controller operably coupled to the plurality of electrodes, the therapy controller attached to the first portion of the cable holder system.

[0063] In some embodiments, the system further comprises a signal cable extending from the electrical connector of the second portion to the first portion and a controller located on the second portion operably coupled to the signal cable. In some embodiments, the system further comprises a controller located away from the second portion and a signal cable operably connecting the controller to the electrical connector of the second portion.

[0064] In some embodiments, the second portion is configured to adjustably slide between a plurality of horizontal positions relative to the first portion, and the system further includes a medical device comprising a ring electrode configured to surround the patient's eye and apply electrical stimulation to the patient's eye, a ground electrode, and a therapy controller operably coupled to the ring electrode and the ground electrode, each of the plurality of horizontal positions being located at a respective distance from the medical device, and the therapy controller is attached to the first portion of the cable holder system and configured to control the electrical stimulation applied by the ring electrode.

[0065] In some embodiments, the system further comprises a medical device comprising a ring electrode surrounding the patient's eye, a plurality of individually actuated electrodes surrounding the eye, a ground electrode, and a therapy controller operably coupled to the ring electrode and the plurality of individually actuated electrodes, the ring electrode configured to deliver a first level of electrical stimulation to the eye and each of the plurality of individually actuated electrodes configured to deliver at least a second level of electrical stimulation, the therapy controller attached to a first portion of the cable holder system and configured to control the electrical stimulation delivered by the ring electrode and the plurality of individually actuated electrodes such that the first level of electrical stimulation is delivered simultaneously (or sequentially) with the second level of electrical stimulation.

[0066] In some embodiments, the medical device comprises a first stimulation device positioned at least partially around a first eye of the patient and a second stimulation device positioned at least partially around a second eye of the patient, an electrical connector of the second part configured to electrically connect to the first stimulation device, the first and second parts together forming a first holder, the system further comprises a third part configured to be supported on the patient's head, a fourth part movably coupled to the third part, and an electrical connector configured to electrically connect to the second stimulation device, the electrical connector being physically connected to the fourth part, the third and fourth parts together forming a second holder, and the first and second holders comprising electronics configured to wirelessly communicate with each other.

[0067] In some embodiments, the present invention provides a method for physically supporting a connection to a medical device for use on a patient, the method comprising the steps of providing a first cable holder part, providing a second cable holder part, the second cable holder part including an electrical connector, coupling the second cable holder part to the first cable holder part such that the second cable holder part is movable relative to the first cable holder part, supporting the first cable holder part on the patient's head, adjusting the distance between the electrical connector and the medical device, and connecting the electrical connector of the second cable holder part to the medical device.

[0068] In some embodiments of the method, supporting the first cable holder portion includes fitting the first cable holder portion at least partially around a first ear of the patient. In some embodiments, supporting the first cable holder portion includes extending the first cable holder portion across a top of the patient's head. In some embodiments, adjusting the distance between the electrical connector and the medical device includes sliding the second cable holder portion to a selected one of a plurality of horizontal positions relative to the first cable holder portion. In some embodiments, adjusting the distance between the electrical connector and the medical device includes rotating the second cable holder portion to a selected one of a plurality of rotational positions relative to the first cable holder portion. In some embodiments, the method further includes providing a signal cable, extending the signal cable from the electrical connector of the second cable holder portion to the first cable holder portion, providing a controller located on the first cable holder portion, and operably coupling the controller to the signal cable.

[0069] It should be understood that the above description is illustrative and not restrictive. Although many of the features and advantages of the various embodiments described herein have been set forth in the foregoing description in the details of the structure and function of the various embodiments, many other embodiments and changes in detail will be apparent to those skilled in the art upon reference to the above description. Therefore, 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. In the appended claims, the terms "including" and "in which" are used as the plain English equivalents of the respective terms "comprising" and "wherein," respectively. Furthermore, terms such as "first," "second," and "third" are used merely as labels and do not impose numerical requirements on their objects.

Claims

1. 1. A system comprising an electrical stimulation device, the electrical stimulation device comprising: a first electrode substrate configured to surround a first eye of a patient without obstructing a view of the first eye; a first ring electrode on the first electrode substrate, the first ring electrode configured to surround the first eye of the patient without obstructing a view of the first eye and to provide electrical stimulation to the first eye; a therapy controller operably coupled to the first ring electrode and configured to control the electrical stimulation provided by the first ring electrode; The system comprises:

2. 2. The system of claim 1, wherein the first ring electrode comprises one or more electrical connections, the system further comprising a conductor holder configured to be supported by a first ear of the patient and to provide a position-variable conductive connector configured to receive the one or more electrical connections of the first ring electrode at one of a plurality of positions between the first eye and the first ear of the patient.

3. 2. The system of claim 1, wherein the electrical stimulation device is operably coupled to the therapy controller and further comprises at least a first ground electrode configured to be placed in contact with the patient's skin at a location away from the first eye of the patient and configured to provide a return path for the electrical stimulation.

4. The system of claim 1 , wherein the first ring electrode, when activated by the therapy controller, delivers the electrical stimulation around an entire circumference of the first ring electrode.

5. The system of claim 1 , wherein the first ring electrode, when activated by the therapy controller, delivers the electrical stimulation to one or more selected locations on the first ring electrode.

6. The electrical stimulation device comprises: a second electrode substrate configured to surround a second eye of the patient; and a second ring electrode on the second electrode substrate, the second ring electrode surrounding the second eye of the patient and configured to deliver electrical stimulation to the second eye, the second ring electrode being further operably coupled to the therapy controller; The system of claim 1 further comprising:

7. 2. The system of claim 1, wherein the first eye includes a first orbit and a first eyeball, and the first electrode substrate is configured to fit within the first orbit of the first eye such that it overlies an outer portion of the first eyeball of the first eye.

8. 1. A system comprising an electrical stimulation device, the electrical stimulation device comprising: a first electrode substrate configured to surround a first eye of a patient without covering the first eye; a first ring electrode on the first electrode substrate, the first ring electrode configured to surround but not cover the first eye of the patient and to provide electrical stimulation to the first eye; a therapy controller operably coupled to the first ring electrode and configured to control the electrical stimulation provided by the first ring electrode, the therapy controller comprising a microprocessor, the electrical stimulation device further comprising a first plurality of individually actuatable electrodes on the first electrode substrate, each of the first plurality of individually actuatable electrodes being operably coupled to the microprocessor of the therapy controller; The system comprises:

9. 1. A system comprising an electrical stimulation device, the electrical stimulation device comprising: a first electrode substrate configured to surround a first eye of a patient without covering the first eye; a first ring electrode on the first electrode substrate, the first ring electrode configured to surround but not cover the first eye of the patient and to provide electrical stimulation to the first eye; a therapy controller operably coupled to the first ring electrode and configured to control the electrical stimulation provided by the first ring electrode; a first plurality of individually actuatable electrodes on the first electrode substrate, the first plurality of individually actuatable electrodes operably coupled to the therapy controller, the electrical stimulus being formed by a combination of a first level of therapeutic stimulation provided by the first ring electrodes and at least a second level of therapeutic stimulation provided by one or more of the first plurality of individually actuatable electrodes; The system comprises:

10. 1. A system comprising an electrical stimulation device, the electrical stimulation device comprising: a first electrode substrate configured to surround a first eye of a patient without covering the first eye; a first ring electrode on the first electrode substrate, the first ring electrode configured to surround but not cover the first eye of the patient and to provide electrical stimulation to the first eye; a therapy controller operably coupled to the first ring electrode and configured to control the electrical stimulation provided by the first ring electrode; a first plurality of individually actuatable electrodes on the first electrode substrate, the first plurality of individually actuatable electrodes operably coupled to the therapy controller, the first plurality of individually actuatable electrodes positioned within a circumference defined by the first ring electrode, and the electrical stimulus formed by a combination of a first subthreshold level of therapeutic stimulation provided by the first ring electrode and a simultaneous second level of therapeutic stimulation provided by one or more of the first plurality of individually actuatable electrodes; The system comprises:

11. 1. A method for providing electrical stimulation to a patient, comprising: providing a first electrode substrate, the first electrode substrate comprising a first ring electrode; applying the first electrode substrate to the patient's skin, the application of the first electrode substrate including surrounding the first eye with the first electrode substrate and the first ring electrode without obstructing a view of the first eye of the patient; applying an electrical stimulus to the first eye via the first ring electrode; The method includes:

12. providing at least a first ground electrode; applying the at least a first ground electrode to the patient's skin, the application of the electrical stimulation including controlling a treatment current between the first ring electrode and the at least a first ground electrode; The method of claim 11 further comprising:

13. The method of claim 11 , wherein applying the electrical stimulus comprises generating the electrical stimulus around an entire circumference of the first ring electrode.

14. The method of claim 11 , wherein applying the electrical stimulus comprises generating the electrical stimulus at one or more selected locations on the first ring electrode.

15. providing a second electrode substrate, the second electrode substrate comprising a second ring electrode; applying the second electrode substrate to the patient's skin, the application of the second electrode substrate comprising surrounding a second eye of the patient with the second electrode substrate and the second ring electrode; applying an electrical stimulus to the second eye via the second ring electrode; The method of claim 11 further comprising:

16. 12. The method of claim 11 , wherein the first eye comprises a first orbit and a first eyeball, and applying the first electrode substrate comprises fitting the first electrode substrate within the first orbit of the first eye such that the first electrode substrate overlies an outer portion of the first eyeball of the first eye.

17. 12. The method of claim 11, further comprising the step of providing a battery powered microprocessor, and applying the electrical stimulus comprises controlling generation of the electrical stimulus using the microprocessor.

18. 1. A method for providing electrical stimulation to a patient, comprising: providing a first electrode substrate, the first electrode substrate comprising a first ring electrode; applying the first electrode substrate to the patient's skin, the application of the first electrode substrate including surrounding the first eye of the patient with the first electrode substrate and the first ring electrode without covering the first eye; applying an electrical stimulus to the first eye via the first ring electrode; providing a first plurality of individually actuatable electrodes on the first electrode substrate, the application of the electrical stimulus including generating a combination of a first level of therapeutic stimulation provided by the first ring electrode and at least a second level of therapeutic stimulation provided by one or more of the first plurality of individually actuatable electrodes; The method includes:

19. 1. A method for providing electrical stimulation to a patient, comprising: providing a first electrode substrate, the first electrode substrate comprising a first ring electrode; applying the first electrode substrate to the patient's skin, the application of the first electrode substrate including surrounding the first eye of the patient with the first electrode substrate and the first ring electrode without covering the first eye; applying an electrical stimulus to the first eye via the first ring electrode; providing a first plurality of individually actuatable electrodes on the first electrode substrate, the application of the electrical stimulation including generating a combination of a first subthreshold level of therapeutic stimulation provided by the first ring electrode and a simultaneous second level of therapeutic stimulation provided by one or more of the first plurality of individually actuatable electrodes; The method includes:

20. 1. A system for delivering electrical stimulation to a first eye of a patient, comprising: A first substrate; means for applying a first subthreshold level and a simultaneous second level of therapeutic electrical stimulation to the first eye of the patient on the first substrate; means for controlling the first threshold level and the simultaneous second level of therapeutic electrical stimulation, the means being electrically coupled to the means for applying; A system comprising:

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