Apparatus for neurostimulation

Various systems and methods related to the design and manufacturing of wearable patches for long-term, controlled stimulation of highly-localized regions on the skin of a wearer, including for the practice of acupuncture, are disclosed and claimed.

This invention is not the subject of federally sponsored research or development.

RESERVATION OF COPYRIGHTS

Portions of the disclosure of this document contain material that is subject to copyright protection. The copyright owner has no objection to any reproduction of the document or disclosure as it appears in official records, but reserves all remaining rights under copyright.

BACKGROUND OF THE INVENTION

The practice of acupuncture relies upon the application of a mechanical and/or electrical stimulus at a highly localized region of a patient's skin. Acupuncture is carried out by trained practitioners who direct stimuli to specific areas, and it is generally practiced in an acute manner, meaning that therapy is applied by the practitioner for the duration of a session, after which it is terminated.

It has been postulated that the ability to deliver acupuncture chronically and continuously, that is for periods of hours, days or weeks, could improve the outcomes for the practice of acupuncture.

Current methods, which employ needles placed by a practitioner to stimulate acupuncture points, and through which (optionally) an electrical current is applied, are not practical for long term use since the needles interfere with normal clothing and pose a hazard for injury if left in place outside of the acupuncture session. In addition, current methods for stimulating acupuncture points do not allow for periodic, intermittent or otherwise controlled stimuli over long durations. An acupuncture needle introduced in the skin, for example, continuously stimulates a response for as long as it is in place. Electrical stimulation, when applied, must be controlled by some device connected to the recipient, which necessitates a wired connection between recipient and some external electronics, as well as intervention from an operator or practitioner if stimulation conditions (i.e. current on/off, or current intensity) are to be varied.

Acupuncture applied in a controlled and chronic basis may have applications to treating a wide variety of disorders including depression and anxiety, musculoskeletal pain, drug and alcohol addiction, menstrual cramping, and other causes of pain. In addition such a system may be useful for inducing or terminating a pregnancy.

There is a need for systems and methods that address shortcomings in the art. Specifically, it is desirable to provide stimuli to one or more acupuncture points for long periods of time, spanning hours or days. During such long-term treatment, it would be desirable to control or manipulate the duty cycle, intensity, waveform, frequency, and other stimulation parameters automatically during the application of the stimuli. Accordingly, a device for providing such therapy should be small (i.e. thin and occupy a small area), fully autonomous (i.e. not connected or wired to other units or components) and capable of operating autonomously for days or weeks without any operator intervention. The device should also contain a practical, compact and integrated device for providing highly localized stimulation to the acupuncture point.

The invention provides improved elements and arrangements thereof, for the purposes described, which are inexpensive, dependable and effective in accomplishing intended purposes of the invention.

Other features and advantages of the invention will become apparent from the following description of the preferred embodiments, which refers to the accompanying drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

This disclosure is not limited in application to the details of construction and the arrangement of components set forth or illustrated in the drawings herein. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Phraseology and terminology used herein is for description and should not be regarded as limiting. Uses of “including,” “comprising” or “having” and variations thereof herein are meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless limited otherwise, “connected,” “coupled” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. “Connected” and “coupled” and variations thereof are not restricted to physical or mechanical or electrical connections or couplings. Furthermore, and as described in subsequent paragraphs, the specific mechanical or electrical configurations described or illustrated are intended to exemplify embodiments of the disclosure. However, alternative mechanical or electrical configurations are possible, which are considered to be within the teachings of the disclosure. Furthermore, unless otherwise indicated, “or” is to be considered inclusive.

The invention provides stimuli to one or more acupuncture points for long periods of time, spanning hours or days. During long-term treatment, the invention controls or manipulates the duty cycle, intensity, waveform, frequency, and other stimulation parameters automatically during the application of the stimuli. The invention provides a device for providing such therapy that is small (i.e. thin and occupy a small area), fully autonomous (i.e. not connected or wired to other units or components) and capable of operating autonomously for days or weeks without any operator intervention. The invention provides a practical, compact and integrated device for providing highly localized stimulation to an acupuncture point.

Referring toFIG. 1, an embodiment of an apparatus10for neurostimulation configured according to principles of the invention includes at least an electrode6mounted on an electrical connector5. Electrical connector5is connected to a circuit board4on which various electrical components are mounted. A backing2mounts on circuit board4and can be adhered to a skin S. A cover7adhesively mounts on patient's skin S and potentially, but not necessarily on backing2, circuit board4, the electrical components or electrical connector5.

Circuit board4essentially provides a communications circuit (not shown) with which controller14and the various electrical components mounted thereon communicate, and an energy circuit (not shown) for delivering electrical or electrically-induced stimulus to electrode6.

Electrode6has a needle6bwith an anchor6a. Needle6bhas a length26extending from anchor6athat ranges from 0.5 mm to 25 mm or otherwise appropriately configured to provide sufficient penetration depth to pass the epidermis without posing a health hazard to the patient.

Electrode6is constructed, arranged and configured to be insulated from circuit board4, or at least the communications circuit (not shown) thereof, and have needle6boperatively connected or in communication with the energy circuit (not shown). To this end, anchor6amay be constructed of non-conductive material. Needle6bis constructed of metal or other material, such as a polymer, that is responsive to communications, signals or stimuli from circuit board4, and capable of providing electrical and/or magnetic stimulation to the tissue in which it is emplaced.

One embodiment of the invention provides two electrodes6arranged and configured for relatively close emplacement at an acupuncture site such that the one of electrodes6provides a return path for electrical and/or magnetic energy originating from the other of electrodes6.

Electrical connector5may be formed integral with, hence as an extension of needle6b, or configured to be in electrical communication therewith.

Electrical components on circuit board4may include a controller14, battery15, power switch19, lamp20, attenuator(s)3and a capacitor (not shown). Controller14includes a memory and other hardware elements sufficient to permit programming thereof, execute a treatment program and control necessary electrical components for administering electrical and/or magnetic stimuli via electrode6.

Battery15should be sized and configured to provide sufficient energy to apparatus10to support its operation for a pre-determined duration, ranging from hours to days. Preferably, battery15is rechargeable and/or replaceable.

Power switch19provides for energizing apparatus10for effecting treatment. Preferably, power switch19is configured to require minimal physical force for its actuation so as to minimize dislocation or agitation of apparatus relative to the patient. Power switch19also should be configured to be insensitive to unanticipated contact with objects during the course of ordinary living. For example, power switch19may possess sensitivity to touch comparable to the screens of many portable electronic devices, such as that of an iPhone®.

Lamp20should be a very low-power LED or other light-emitting source for indicating that apparatus10is energized or operational. Lamp20also may emit light in a manner that corresponds with the stimuli being expressed through electrode6, as described in greater detail below.

One or more attenuator3may be operatively connected with controller14for controlling attributes of the stimulus provided during treatment, such as intensity, duration and/or frequency.

Capacitor (not shown) provides for building up sufficient electrical charge for administering stimuli at a desired level.

Energy circuit (not shown) of circuit board4is operatively connected with electrical connector5.

Backing2, preferably, is constructed of a soft and flexible material that molds to the contours of the human body. Backing2should be small and unobtrusive with a relatively flat profile. Backing2may be skin-toned.

An embodiment of the invention provides for incorporating electrode6, specifically anchor6a, in backing2. Such construction simplifies emplacement of needle6band adherence of backing2, and assures accurate and reliable location and penetration of the skin through the epidermis into the dermis and/or hypodermis below.

An embodiment of the invention provides for eliminating circuit board4and instead embedding or mounting necessary electrical components and interconnects or circuitry onto backing2. In combination with the foregoing embodiment, the electrical components and electrode6would be integral with backing2.

Cover7provides for protecting apparatus10from contaminants and discouraging its dislodgment during treatment. Preferably, cover7has adhesive at least along a peripheral band18for adhering to skin S. Cover7and adhesive should be configured to provide a water tight enclosure to prevent moisture from damaging electrical components3or other potentially corruptible components of apparatus10. Alternatively, the entire underside of cover7may include adhesive for adhering to backing2, circuit board4, electrical components and/or electrical connector5.

An embodiment of apparatus10provides cover7with sufficient pliability to manipulate controls on circuit board4, such as power switch19and attenuator(s)3.

An embodiment of apparatus10provides cover7with openings (not shown) for receiving, hence revealing, and sealing around the aforementioned controls and/or lamp20on circuit board4.

An embodiment of apparatus10provides cover7that is constructed of a material that is clear or sufficiently translucent to perceive light emitted from lamp20.

An embodiment of apparatus10includes a reinforcement boss21mounted on cover, preferably centered on an axis of electrode6. Boss21protects the delicate electronics on circuit board4and aids in accurate emplacement of apparatus10. Preferably, boss21includes indicia, such as “push here,” to aid a practitioner with emplacement without damaging apparatus10.

An embodiment of apparatus10includes a mechanism16for rotating electrode6relative to circuit board4. Mechanism16may include an electric motor (not shown) having an output shaft (not shown) terminating with a gear (not shown) that drives a second gear (not shown) mounted on electrode6.

Referring also toFIG. 2, an embodiment of apparatus10includes a surface electrode22operatively connected with energy circuit (not shown) circuit board4and disposed between circuit board4or backing2, as shown, and skin S. Surface electrode22may be used in concert with needle6bto stimulate localized dermal areas. Surface electrode22may be designed with features and geometries to enhance the localization of the delivered current, or to carefully control the path of current from a source electrode through the skin to a second return electrode.

Referring toFIGS. 3A and 3B, an embodiment of the invention includes an electromagnetic coil23mounted on and operatively connected with energy circuit (not shown) of circuit board4. Electromagnetic coil23is arranged and configured to conduct electrical current so as to generate a transient magnetic field in sub-dermal tissue.

An embodiment of the invention includes an electrode24having a needle24band an anchor24amounted relative to and operatively connected with energy circuit (not shown) of circuit board4. Needle24bis arranged and configured to be responsive to a transient magnetic field that electromagnetic coil23generates to provide a highly localized, deep magnetic field, or combination of electrical and magnetic stimulation in sub-dermal tissue.

An embodiment of the invention provides for integrating an electromagnetic coil (not shown) with needle24b.

Referring toFIGS. 4A and 4B, an embodiment of the invention includes a flat, spiral electromagnetic coil25mounted on and operatively connected with energy circuit (not shown) of circuit board4. Electromagnetic coil24is arranged and configured to conduct electrical current so as to generate a transient magnetic field in sub-dermal tissue.

An embodiment of the invention includes an electrode (not shown) comparable to electrode24mounted relative to and operatively connected with energy circuit (not shown) of circuit board4, and arranged and configured to be responsive to a transient magnetic field that electromagnetic coil24generates.

An embodiment of the invention provides for integrating the active elements of apparatus10into an article of clothing, such as a sock or a hat, for stimulating dermal tissue on the foot or head, respectively, or in another area of the body in intimate contact with the article of clothing.

Referring again toFIG. 1and toFIGS. 5A and 5B, in practice, an acupuncture practitioner, having located an acupuncture site on a patient, selects an appropriately-sized apparatus10. An embodiment of the invention provides for the practitioner removing any release sheet that protect adhesive portions of backing2and cover7from premature adherence. After positioning the distal end of needle6bproximate to the acupuncture site, the practitioner presses against boss21, thereby urging needle6binto skin S. Upon needle6battaining full emplacement, backing2and periphery18of cover7contact and adhere to skin S, securing needle6btherein until it is no longer needed for treatment.

Referring also toFIG. 6, once emplaced, apparatus10presents a low-profile, temporary fixture on skin S not unlike an ordinary bandage.

Once emplaced, if apparatus10employs controls, such as attenuator(s)3, located on controller14or circuit board4for tailoring the program of stimulation desired for treatment, the practitioner would manipulate those controls accordingly.

An embodiment of the invention does not rely on controls located on apparatus10, but rather a second controller (not shown), such as a computer or mobile device, connected to controller14via a hard wire interconnect (not shown) or, preferably, wireless communication, such as bluetooth, wi-fi or cellular connectivity. With such embodiments, the practitioner or patient would establish through an interface the stimulation protocols and values that would be relayed to controller14for subsequent execution by the electrical components. In these embodiments, apparatus10itself would execute the programmed instructions after its disconnection from second controller (not shown).

Once the initial programming is performed, there would be no need for further (human) intervention to allow apparatus10to function. However, an embodiment of the invention provides for monitoring apparatus10via wireless connectivity with a second controller (not shown). This would allow a practitioner or patient to monitor the current health and functioning of apparatus10, such as battery levels.

An embodiment of the invention provides for managing multiple apparatuses10emplaced in a patient via a central second controller (not shown). In such embodiment, the second controller interface would allow for coordination of the stimuli expressed by the diverse apparatuses10.

An embodiment of the invention also provides for managing and coordinating the stimuli expressed by multiple apparatuses10, but via non-centralized, networked communications among the apparatuses10. In other words, controllers14of each apparatus10would communicate and coordinate stimuli expressions among all of the apparatuses10.

Referring toFIG. 7, according to whatever treatment program is initiated, controller14would maintain in a register/memory thereof the out configuration of the desired output, stimuli having specified intensities11, durations13and frequencies12, defining a waveform17. Waveform17may be irregular, for example, where stimuli are only desired at certain times of the day or for intensity or waveform to be varied among or between a set of stimulation parameters.

In embodiments of apparatus10including mechanism16, controller14also is programmable to rotate electrodes6clockwise and/or counterclockwise at designated times.

The digital outputs of controller14, preferably through intermediate logic gates, control the analog portion of the communications circuit (not shown), which would produce the appropriate waveform17defining energizing of and stimuli expressed by needle6b. This analog portion might be a current driver or a voltage driver from a dedicated integrated circuit or a configuration of discrete components, including resistors and capacitors. Controller14configures the inputs of the driver or tunes aspects of the discrete components to achieve waveform17.

Where magnetic stimulation is desired, with or without an electrode, the basic input to the coil/needle also would be a pulsed waveform17.

The invention is not limited to the particular embodiments described and depicted herein, rather only to the following claims.