Abstract:
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.

Description:
REFERENCE TO EARLIER APPLICATION 
       [0001]    This Application incorporates by reference and, under 35 U.S.C. §119(e), claims priority to U.S. Provisional Patent Application Ser. No. 61/984,065 filed on Apr. 25, 2014. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    This invention is not the subject of federally sponsored research or development. 
       RESERVATION OF COPYRIGHTS 
       [0003]    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 
       [0004]    The practice of acupuncture relies upon the application of a mechanical and/or electrical stimulus at a highly localized region of a patient&#39;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. 
         [0005]    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. 
         [0006]    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. 
         [0007]    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. 
         [0008]    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. 
         [0009]    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. 
         [0010]    Other features and advantages of the invention will become apparent from the following description of the preferred embodiments, which refers to the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    The invention is described in detail below with reference to the following figures, throughout which similar reference characters denote corresponding features consistently, wherein: 
           [0012]      FIG. 1  is a cross-sectional detail view of embodiments of an apparatus for neurostimulation configured according to principles of the invention; 
           [0013]      FIG. 2  is a cross-sectional detail view drawn along line II-II in  FIG. 1 ; 
           [0014]      FIG. 3A  is a cross-sectional detail view of another embodiment of an apparatus for neurostimulation configured according to principles of the invention; 
           [0015]      FIG. 3B  is an side elevational view of section IIIB of  FIG. 3A ; 
           [0016]      FIG. 4A  is a cross-sectional detail view of another embodiment of an apparatus for neurostimulation configured according to principles of the invention; 
           [0017]      FIG. 4B  is a top, front, left perspective view of section IVB of  FIG. 4A ; 
           [0018]      FIG. 5A  is a cross-sectional detail view of human skin; 
           [0019]      FIG. 5B  is an enlarged view of section VB of  FIG. 5A  shown with the embodiment of  FIG. 1  emplaced; 
           [0020]      FIG. 6  is an environmental perspective view of the embodiment of  FIG. 1  emplaced in skin; and 
           [0021]      FIG. 7  is a schematic diagram of a waveform pertaining to stimulus exhibited by the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0022]    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. 
         [0023]    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. 
         [0024]    Referring to  FIG. 1 , an embodiment of an apparatus  10  for neurostimulation configured according to principles of the invention includes at least an electrode  6  mounted on an electrical connector  5 . Electrical connector  5  is connected to a circuit board  4  on which various electrical components are mounted. A backing  2  mounts on circuit board  4  and can be adhered to a skin S. A cover  7  adhesively mounts on patient&#39;s skin S and potentially, but not necessarily on backing  2 , circuit board  4 , the electrical components or electrical connector  5 . 
         [0025]    Circuit board  4  essentially provides a communications circuit (not shown) with which controller  14  and the various electrical components mounted thereon communicate, and an energy circuit (not shown) for delivering electrical or electrically-induced stimulus to electrode  6 . 
         [0026]    Electrode  6  has a needle  6   b  with an anchor  6   a.  Needle  6   b  has a length  26  extending from anchor  6   a  that 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. 
         [0027]    Electrode  6  is constructed, arranged and configured to be insulated from circuit board  4 , or at least the communications circuit (not shown) thereof, and have needle  6   b  operatively connected or in communication with the energy circuit (not shown). To this end, anchor  6   a  may be constructed of non-conductive material. Needle  6   b  is constructed of metal or other material, such as a polymer, that is responsive to communications, signals or stimuli from circuit board  4 , and capable of providing electrical and/or magnetic stimulation to the tissue in which it is emplaced. 
         [0028]    One embodiment of the invention provides two electrodes  6  arranged and configured for relatively close emplacement at an acupuncture site such that the one of electrodes  6  provides a return path for electrical and/or magnetic energy originating from the other of electrodes  6 . 
         [0029]    Electrical connector  5  may be formed integral with, hence as an extension of needle  6   b,  or configured to be in electrical communication therewith. 
         [0030]    Electrical components on circuit board  4  may include a controller  14 , battery  15 , power switch  19 , lamp  20 , attenuator(s)  3  and a capacitor (not shown). Controller  14  includes 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 electrode  6 . 
         [0031]    Battery  15  should be sized and configured to provide sufficient energy to apparatus  10  to support its operation for a pre-determined duration, ranging from hours to days. Preferably, battery  15  is rechargeable and/or replaceable. 
         [0032]    Power switch  19  provides for energizing apparatus  10  for effecting treatment. Preferably, power switch  19  is configured to require minimal physical force for its actuation so as to minimize dislocation or agitation of apparatus relative to the patient. Power switch  19  also should be configured to be insensitive to unanticipated contact with objects during the course of ordinary living. For example, power switch  19  may possess sensitivity to touch comparable to the screens of many portable electronic devices, such as that of an iPhone®. 
         [0033]    Lamp  20  should be a very low-power LED or other light-emitting source for indicating that apparatus  10  is energized or operational. Lamp  20  also may emit light in a manner that corresponds with the stimuli being expressed through electrode  6 , as described in greater detail below. 
         [0034]    One or more attenuator  3  may be operatively connected with controller  14  for controlling attributes of the stimulus provided during treatment, such as intensity, duration and/or frequency. 
         [0035]    Capacitor (not shown) provides for building up sufficient electrical charge for administering stimuli at a desired level. 
         [0036]    Energy circuit (not shown) of circuit board  4  is operatively connected with electrical connector  5 . 
         [0037]    Backing  2 , preferably, is constructed of a soft and flexible material that molds to the contours of the human body. Backing  2  should be small and unobtrusive with a relatively flat profile. Backing  2  may be skin-toned. 
         [0038]    An embodiment of the invention provides for incorporating electrode  6 , specifically anchor  6   a,  in backing  2 . Such construction simplifies emplacement of needle  6   b  and adherence of backing  2 , and assures accurate and reliable location and penetration of the skin through the epidermis into the dermis and/or hypodermis below. 
         [0039]    An embodiment of the invention provides for eliminating circuit board  4  and instead embedding or mounting necessary electrical components and interconnects or circuitry onto backing  2 . In combination with the foregoing embodiment, the electrical components and electrode  6  would be integral with backing  2 . 
         [0040]    Cover  7  provides for protecting apparatus  10  from contaminants and discouraging its dislodgment during treatment. Preferably, cover  7  has adhesive at least along a peripheral band  18  for adhering to skin S. Cover  7  and adhesive should be configured to provide a water tight enclosure to prevent moisture from damaging electrical components  3  or other potentially corruptible components of apparatus  10 . Alternatively, the entire underside of cover  7  may include adhesive for adhering to backing  2 , circuit board  4 , electrical components and/or electrical connector  5 . 
         [0041]    An embodiment of apparatus  10  provides cover  7  with sufficient pliability to manipulate controls on circuit board  4 , such as power switch  19  and attenuator(s)  3 . 
         [0042]    An embodiment of apparatus  10  provides cover  7  with openings (not shown) for receiving, hence revealing, and sealing around the aforementioned controls and/or lamp  20  on circuit board  4 . 
         [0043]    An embodiment of apparatus  10  provides cover  7  that is constructed of a material that is clear or sufficiently translucent to perceive light emitted from lamp  20 . 
         [0044]    An embodiment of apparatus  10  includes a reinforcement boss  21  mounted on cover, preferably centered on an axis of electrode  6 . Boss  21  protects the delicate electronics on circuit board  4  and aids in accurate emplacement of apparatus  10 . Preferably, boss  21  includes indicia, such as “push here,” to aid a practitioner with emplacement without damaging apparatus  10 . 
         [0045]    An embodiment of apparatus  10  includes a mechanism  16  for rotating electrode  6  relative to circuit board  4 . Mechanism  16  may 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 electrode  6 . 
         [0046]    Referring also to  FIG. 2 , an embodiment of apparatus  10  includes a surface electrode  22  operatively connected with energy circuit (not shown) circuit board  4  and disposed between circuit board  4  or backing  2 , as shown, and skin S. Surface electrode  22  may be used in concert with needle  6   b  to stimulate localized dermal areas. Surface electrode  22  may 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. 
         [0047]    Referring to  FIGS. 3A and 3B , an embodiment of the invention includes an electromagnetic coil  23  mounted on and operatively connected with energy circuit (not shown) of circuit board  4 . Electromagnetic coil  23  is arranged and configured to conduct electrical current so as to generate a transient magnetic field in sub-dermal tissue. 
         [0048]    An embodiment of the invention includes an electrode  24  having a needle  24   b  and an anchor  24   a  mounted relative to and operatively connected with energy circuit (not shown) of circuit board  4 . Needle  24   b  is arranged and configured to be responsive to a transient magnetic field that electromagnetic coil  23  generates to provide a highly localized, deep magnetic field, or combination of electrical and magnetic stimulation in sub-dermal tissue. 
         [0049]    An embodiment of the invention provides for integrating an electromagnetic coil (not shown) with needle  24   b.    
         [0050]    Referring to  FIGS. 4A and 4B , an embodiment of the invention includes a flat, spiral electromagnetic coil  25  mounted on and operatively connected with energy circuit (not shown) of circuit board  4 . Electromagnetic coil  24  is arranged and configured to conduct electrical current so as to generate a transient magnetic field in sub-dermal tissue. 
         [0051]    An embodiment of the invention includes an electrode (not shown) comparable to electrode  24  mounted relative to and operatively connected with energy circuit (not shown) of circuit board  4 , and arranged and configured to be responsive to a transient magnetic field that electromagnetic coil  24  generates. 
         [0052]    An embodiment of the invention provides for integrating the active elements of apparatus  10  into 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. 
         [0053]    Referring again to  FIG. 1  and to  FIGS. 5A and 5B , in practice, an acupuncture practitioner, having located an acupuncture site on a patient, selects an appropriately-sized apparatus  10 . An embodiment of the invention provides for the practitioner removing any release sheet that protect adhesive portions of backing  2  and cover  7  from premature adherence. After positioning the distal end of needle  6   b  proximate to the acupuncture site, the practitioner presses against boss  21 , thereby urging needle  6   b  into skin S. Upon needle  6   b  attaining full emplacement, backing  2  and periphery  18  of cover  7  contact and adhere to skin S, securing needle  6   b  therein until it is no longer needed for treatment. 
         [0054]    Referring also to  FIG. 6 , once emplaced, apparatus  10  presents a low-profile, temporary fixture on skin S not unlike an ordinary bandage. 
         [0055]    Once emplaced, if apparatus  10  employs controls, such as attenuator(s)  3 , located on controller  14  or circuit board  4  for tailoring the program of stimulation desired for treatment, the practitioner would manipulate those controls accordingly. 
         [0056]    An embodiment of the invention does not rely on controls located on apparatus  10 , but rather a second controller (not shown), such as a computer or mobile device, connected to controller  14  via 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 controller  14  for subsequent execution by the electrical components. In these embodiments, apparatus  10  itself would execute the programmed instructions after its disconnection from second controller (not shown). 
         [0057]    Once the initial programming is performed, there would be no need for further (human) intervention to allow apparatus  10  to function. However, an embodiment of the invention provides for monitoring apparatus  10  via wireless connectivity with a second controller (not shown). This would allow a practitioner or patient to monitor the current health and functioning of apparatus  10 , such as battery levels. 
         [0058]    An embodiment of the invention provides for managing multiple apparatuses  10  emplaced 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 apparatuses  10 . 
         [0059]    An embodiment of the invention also provides for managing and coordinating the stimuli expressed by multiple apparatuses  10 , but via non-centralized, networked communications among the apparatuses  10 . In other words, controllers  14  of each apparatus  10  would communicate and coordinate stimuli expressions among all of the apparatuses  10 . 
         [0060]    Referring to  FIG. 7 , according to whatever treatment program is initiated, controller  14  would maintain in a register/memory thereof the out configuration of the desired output, stimuli having specified intensities  11 , durations  13  and frequencies  12 , defining a waveform  17 . Waveform  17  may 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. 
         [0061]    In embodiments of apparatus  10  including mechanism  16 , controller  14  also is programmable to rotate electrodes  6  clockwise and/or counterclockwise at designated times. 
         [0062]    The digital outputs of controller  14 , preferably through intermediate logic gates, control the analog portion of the communications circuit (not shown), which would produce the appropriate waveform  17  defining energizing of and stimuli expressed by needle  6   b . 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. Controller  14  configures the inputs of the driver or tunes aspects of the discrete components to achieve waveform  17 . 
         [0063]    Where magnetic stimulation is desired, with or without an electrode, the basic input to the coil/needle also would be a pulsed waveform  17 . 
         [0064]    The invention is not limited to the particular embodiments described and depicted herein, rather only to the following claims.