Apparatus and method for ocular microcurrent stimulation therapy

• US 10,391,312 B2
• Filed: 09/13/2016
• Issued: 08/27/2019
• Est. Priority Date: 09/15/2015
• Status: Active Grant

• Current Assignee: I-Lumen Scientific, Inc.
• Original Assignee: I-Lumen Scientific, Inc.
• Inventors: Mowery, Blair P., Masko, Marshall T., Jarding, John B., Tapp, Gary A.
• Primary Examiner(s): Fairchild, Mallika D
• Application Number:
  US15/759,515
• Publication Number:
  US 20190143116A1
• Time in Patent Office: 1,078 Days
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0496 characterised by using specific chemical compositions, e.g. hydrogel compositions, adhesives
• CPC Class Codes: A61N 1/36014 External stimulators, e.g. with patch electrodes external pacemakers A61N1/3625
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36046 of the eye

Abstract

Devices and methods to deliver microcurrent stimulation therapy to the human body, when connected to a micro-stimulation current-generating apparatus. The method of applying microcurrent stimulation therapy to key points around the eye for treatment of problems such as macular degeneration, retinitis pigmentosa, glaucoma, optic neuritis and other eye-related or nerve-related conditions, as well as other diseases, such as Bell'"'"'s Palsy, requiring localized stimulation to the eyes and/or on other body parts.

Claims

1. An apparatus comprising:

a disposable therapy appliance that includes;

a strip of material containing a plurality of electrodes configured to apply microcurrent stimulation therapy to a patient, wherein each electrode is no larger than 36 mm², wherein the strip is shaped to be positioned to place electrodes on an upper eyelid and a lower eyelid of the patient'"'"'s skin for a treatment session, wherein the strip is bifurcated such that the strip includes a first elongated portion that is adapted to be placed on the upper eyelid and a second elongated portion that is adapted to be placed on the lower eyelid, and wherein each one of the plurality of electrodes is configured to be individually activated at a time for microcurrent stimulation without activation of any other ones of the plurality of electrodes during that time.

2. The apparatus of claim 1, wherein the strip of material includes an adhesive suitable to adhere the strip to the skin.

3. The apparatus of claim 1, wherein the strip of material includes an amount of conductive gel on a skin-contact point of each one of the plurality of electrodes, the apparatus further including:

a removable protective layer that separately encloses each amount of conductive gel such that the amounts of conductive gel do not touch each other when the strip is applied to the patient'"'"'s skin.

4. The apparatus of claim 1, further comprising:

a microcurrent-stimulation controller, wherein the electrodes are spaced at predetermined location points along the strip of material, and are wired individually and separately to the microcurrent-stimulation controller, and wherein the microcurrent-stimulation controller generates a prescribed microcurrent delivered to each electrode of the plurality of electrodes in a temporal sequence.

5. The apparatus of claim 4, wherein the microcurrent-stimulation controller apparatus contains a software system that is programmed to sequence pulses delivered to the plurality of electrodes for the microcurrent stimulation therapy based on a set of parameters selected for the patient.

6. The apparatus of claim 4, wherein the microcurrent-stimulation controller apparatus is configured to detect electrical impedance between the electrodes and the patient, and thereby provide feedback to the controller to automatically adjust the amount of microcurrent simulation, in order to deliver the amount of microcurrent stimulation originally pre-selected for the patient'"'"'s treatment session by a clinician to achieve improved therapy.

7. The apparatus of claim 4,

wherein the microcurrent-stimulation controller apparatus includes a current controller circuit operative to control an amount of current;

wherein the microcurrent-stimulation controller apparatus includes a current sensing circuit operative to provide a first feedback signal indicative of the amount of current delivered to one of the plurality of electrodes; and

wherein the software system in the microcurrent-stimulation controller apparatus adjusts the current controller circuit based on the first feedback signal and on the set of parameters selected for the patient.

8. The apparatus of claim 4, wherein the microcurrent-stimulation controller apparatus includes a patient-activatable switch, and wherein the microcurrent-stimulation controller apparatus is configured to stop therapy upon activation of the switch.

9. The apparatus of claim 4, wherein the microcurrent-stimulation controller apparatus includes a patient-activatable switch, and wherein the microcurrent-stimulation controller apparatus is configured to record a timestamp associated with activation of the switch.

10. The apparatus of claim 4, wherein the microcurrent-stimulation controller apparatus is configured to visibly show status of the treatment session.

11. The apparatus of claim 4, wherein the microcurrent-stimulation controller apparatus is configured to capture data parameters of the treatment session and to transmit the captured data to a base station for analysis to refine later treatment sessions and to confirm the apparatus is working properly and being administered properly, and to ensure consistency of results.

12. The apparatus of claim 4, wherein the microcurrent-stimulation controller apparatus is configured to adjust protocol for a treatment session in a clinic via the software system based on a received WIFI signal.

13. The apparatus of claim 4, wherein the microcurrent-stimulation controller apparatus is configured to adjust protocol for a treatment session in a clinic via the software system based on a signal received from a remote system via the internet.

14. The apparatus of claim 4, wherein the microcurrent-stimulation controller apparatus is configured to adjust protocol for a treatment session based on data received from a USB-connected storage device directly connected to the microcurrent-stimulation controller apparatus.

15. The apparatus of claim 4, wherein the microcurrent-stimulation controller apparatus is configured to adjust protocol for a treatment session based on data wirelessly received from a base station having a USB-connected storage device directly connected to the base station.

16. The apparatus of claim 1, further comprising a vibrator connected to the strip to convey a gentle level of vibration as the microcurrent stimulation therapy is being applied.

17. The apparatus of claim 1, further comprising at least one light emitter device on the strip.

18. The apparatus of claim 1, further comprising at least one light emitter device on the strip, wherein the strip is transparent or translucent such that light from the at least one light emitter device is visible to both the patient and to an outside observer.

19. The apparatus of claim 1, further comprising:

a plurality of light emitter devices on the strip, wherein each respective one of the plurality of electrodes has an associated one of the plurality of light emitter devices in a vicinity of the respective electrode; and

a microcurrent-stimulation controller, wherein the electrodes spaced at predetermined location points along the strip of material, and are wired individually and separately to the microcurrent-stimulation controller, wherein the microcurrent-stimulation controller generates a prescribed microcurrent pulse delivered to each electrode of the plurality of electrodes in a temporal sequence, and wherein the microcurrent-stimulation controller activates the respective associated one of the plurality of light emitter devices during the delivered microcurrent pulse to the respective electrode.

20. The apparatus of claim 19, wherein the microcurrent-stimulation controller is configured to receive activation data from a USB storage device, and wherein the activation data is encrypted, and wherein the encrypted activation data is required to be received by the microcurrent-stimulation controller before a microcurrent stimulation therapy session is initiated.

21. The apparatus of claim 1, wherein the strip of material includes an adhesive suitable to adhere the strip to a goggle device;

the apparatus further comprising;

the goggle device, wherein the goggle device is shaped to hold the plurality of electrodes against the patient'"'"'s skin without any adhesive touching the patient'"'"'s skin.

22. The apparatus of claim 21, further comprising a vibrator connected to the goggle device to convey a gentle level of vibration as the microcurrent stimulation therapy is being applied.

23. The apparatus of claim 1, wherein the upper eyelid and the lower eyelid are associated with a first eye of the patient, and wherein the strip of material is configured to partially encircle the first eye of the patient.

24. The apparatus of claim 1, wherein the upper eyelid and the lower eyelid are associated with a first eye of the patient, and wherein the strip of material is configured to encircle the first eye of the patient.

25. The apparatus of claim 1, wherein the first elongated portion of the strip includes a first plurality of the plurality of electrodes, and wherein the second elongated portion of the strip includes a second plurality of the plurality of electrodes.

26. A method comprising:

providing a disposable strip of material containing a plurality of electrodes configured to apply microcurrent stimulation therapy to a patient, wherein each electrode is no larger than thirty-six (36) mm², wherein the strip is shaped to be positioned to place electrodes on an upper eyelid and a lower eyelid of the patient'"'"'s skin, wherein the strip is bifurcated such that the strip includes a first elongated portion that is adapted to be placed on the upper eyelid and a second elongated portion that is adapted to be placed on the lower eyelid, wherein the electrodes are spaced at predetermined location points along the strip of material, and wherein each one of the plurality of electrodes is configured to be individually activated at a time for microcurrent stimulation without activation of any other ones of the plurality of electrodes during that time;

providing a microcurrent-stimulation controller, wherein the electrodes are wired individually and separately to the microcurrent-stimulation controller;

applying the disposable strip of material to the patient'"'"'s skin;

generating prescribed microcurrent pulses by the microcurrent-stimulation controller; and

delivering the microcurrent pulses to each respective electrode of the plurality of electrodes in a temporal sequence.

27. The method of claim 26, wherein the strip of material includes a pressure-sensitive adhesive suitable to adhere the strip to the skin, and wherein the applying the disposable strip of material to the patient'"'"'s skin includes contacting the adhesive to the patient'"'"'s skin.

28. The method of claim 26, wherein the strip of material includes an amount of conductive gel on a skin-contact point of each one of the plurality of electrodes, and a removable protective layer that separately encloses each amount of conductive gel such that the amounts of conductive gel do not touch each other when the strip is applied to the patient'"'"'s skin.

29. The method of claim 26, further comprising:

sequencing the therapy to the plurality of electrodes under software control;

detecting electrical impedance between the electrodes and the patient; and

providing feedback to automatically adjust a level of microcurrent simulation, in order to deliver the amount of stimulation originally pre-selected for that treatment session to achieve improved and/or optimum therapy.

30. The method of claim 26, further comprising:

conveying a gentle level of vibration as the microcurrent stimulation therapy is being applied.

31. The method of claim 26, further comprising:

emitting light from a goggle; and

holding the strip to the goggle, wherein the goggle presses the electrodes of the strip against the patient'"'"'s skin.

32. The method of claim 26, further comprising:

emitting light from a plurality of light-emitting locations on the strip, wherein each light-emitting location is in a vicinity of an associated respective one of the plurality of electrodes; and

wherein the emitting light from the respective associated one of the plurality of light-emitting locations is during the delivering of the microcurrent pulse to the respective electrode.

33. An apparatus comprising:

a disposable strip of material containing a plurality of electrodes configured to apply microcurrent stimulation therapy to a patient, wherein each electrode is no larger than 36 mm², wherein the strip is shaped to be positioned to place electrodes on an upper eyelid and a lower eyelid of the patient'"'"'s skin, wherein the strip is bifurcated such that the strip includes a first elongated portion that is adapted to be placed on the upper eyelid and a second elongated portion that is adapted to be placed on the lower eyelid, wherein the electrodes are spaced at predetermined location points along the strip of material, and wherein each one of the plurality of electrodes is configured to be individually activated at a time for microcurrent stimulation without activation of any other ones of the plurality of electrodes during that time;

means for applying the disposable strip of material to the patient'"'"'s skin such that each one of the plurality of electrodes is in electrical communication with the patient'"'"'s skin;

means for generating prescribed microcurrent pulses; and

means for delivering the microcurrent pulses to each respective electrode of the plurality of electrodes in a temporal sequence.

34. The apparatus of claim 33, wherein the strip of material includes a pressure-sensitive adhesive suitable to adhere the strip to the skin, and wherein the means for applying the disposable strip of material to the patient'"'"'s skin includes means for contacting the adhesive to the patient'"'"'s skin.

35. The apparatus of claim 33, wherein the strip of material includes an amount of conductive gel on a skin-contact point of each one of the plurality of electrodes, and removable means for separately enclosing each amount of conductive gel such that the amounts of conductive gel do not touch each other when the strip is applied to the patient'"'"'s skin.

36. The apparatus of claim 33, further comprising:

means for sequencing the therapy to the plurality of electrodes under software control;

means for detecting electrical impedance between the electrodes and the patient; and

means for providing feedback to automatically adjust a level of microcurrent simulation, in order to deliver the amount of stimulation originally pre-selected for that treatment session to achieve improved and/or optimum therapy.

37. The apparatus of claim 33, further comprising:

means for conveying a gentle level of vibration as the microcurrent stimulation therapy is being applied.

38. The apparatus of claim 33, further comprising:

means for emitting light from the strip.

39. The apparatus of claim 33, further comprising:

means for emitting light from a plurality of light-emitting locations on the strip, wherein each light-emitting location is in a vicinity of an associated respective one of the plurality of electrodes; and

wherein the means for emitting light from the respective associated one of the plurality of light-emitting locations emits light during the delivering of the microcurrent pulse to the respective electrode.