Abstract:
An apparatus for stimulating auricular points on the human ear is provided using low voltage pulses that are generated and delivered by portions of the apparatus that may be readily removed from the neck and ear, and then easily replaced by the patient to continue therapy.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part of U.S. patent application Ser. No. 12/719,343 filed Mar. 8, 2010 and claims the benefit of U.S. Provisional Application Ser. No. 61/252,338 filed Oct. 16, 2009 under 35 U.S.C. §119(e) for all commonly disclosed subject matter which is expressly incorporated herein by reference in its entirety to form part of the present disclosure. 
    
    
     FIELD OF THE INVENTION 
     This invention relates to an apparatus for stimulating auricular points on the human ear, and, more particularly, to an apparatus having a number of treatment devices coupled to an electronic circuit carried by a housing removably attached to the neck near the ear via a mounting pad wherein the treatment devices may be retained at selected auricular points on the ear, temporarily removed with or without the housing, and then later reattached. 
     BACKGROUND OF THE INVENTION 
     Auricular therapy is based on the concept that nerves in the external ear connect to parts of the brain which have reflex connections to the body. According to auricular therapy, each area of the ear is related to a different anatomical portion of the body. A large number of sites on the ear have been identified which exhibit changes in tenderness and altered blood circulation in response to the presence of disease, injury or other problems in corresponding parts of the body. Auricular therapy has been utilized to treat conditions in distant parts of the body by stimulating the particular point(s) on the ear corresponding to the injured or diseased body part using acupuncture, massage or electric pulses. The most common health conditions treated by auricular therapy including the control of chronic pain, detoxification from addictions, relief from nausea, high blood pressure, arthritis, asthma, indigestion, migraines, urinary problems and nervous disorders. Clinical studies on humans have shown that stimulation of auricular points on the ear appear to cause the systemic release of endogenous morphine or “endorphins” which are particularly effective in the control of chronic pain. 
     SUMMARY OF THE INVENTION 
     This invention is directed to an apparatus for stimulating auricular points on the human ear using electric pulses that are generated and delivered by portions of the apparatus that may be readily removed from the head and ear, and then easily replaced by the patient to continue therapy. 
     In one presently preferred embodiment of this invention, a mounting pad having a reference electrode is attached to the neck near the back of the ear. The mounting pad supports a housing that contains an electronic circuit coupled to the reference electrode and to a wire connected to a number of treatment devices. The circuit is effective to deliver electrical pulses to the treatment devices at a voltage level that may be adjusted. Each treatment device may be held in position at a selected auricular point on the ear by either a backing magnet, located on the side of the ear opposite the treatment device, or a needle assembly having a needle inserted into the ear. 
     An important advantage of the apparatus of this invention is that the housing which contains the electronic circuit, and the treatment devices, may be removed by the patient while the mounting pad and the backing magnet or needle assembly remain in place. This allows the patient to shower, wash his or her hair etc. without damaging the apparatus. Thereafter, the housing may be reattached to the mounting pad and the treatment devices placed back in position, without the assistance of a physician, to resume treatment of the selected auricular area(s). Additionally, unlike prior art devices, the magnitude of the voltage output from the electronic circuit may be adjusted depending upon whether the treatment device is held in place on the ear by a backing magnet or by a needle inserted into the ear. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The structure, operation and advantages of the presently preferred embodiment of this invention will become further apparent upon consideration of the following description, taken in conjunction with the accompanying drawings, wherein: 
         FIG. 1  is schematic, side view of a human head depicting the location at which the mounting pad and circuit housing may be attached to the human body, and the positioning of treatment devices at selected auricular points on an ear; 
         FIG. 2  is an enlarged view of one of the treatment devices shown in  FIG. 1 ; 
         FIG. 3  is a view in partial cross section depicting the side of an ear with a treatment device held in place on the ear by a backing magnet; 
         FIG. 4  is a view in partial cross section illustrating the side of an ear with a treatment device held in place on the ear by a needle assembly; 
         FIG. 5  is an exploded, side view of the components forming the circuit housing of this invention; 
         FIG. 6  is an assembled, side view of the circuit housing depicting the port for connection of the wire coupled to the treatment devices; 
         FIG. 7  is a plan view of the middle plate portion of the circuit housing schematically depicting a printed circuit board in place in the center area thereof; and 
         FIG. 8  is a schematic, block diagram of the electronic circuit employed in the device herein. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring initially to  FIGS. 1 and 2 , the auricular device  10  of this invention comprises a mounting pad  12  having a ground or reference electrode  14 , a circuit housing  16  and treatment devices  18 ,  20  and  22  each connected by a common wire  24  to the housing  16 . The device  10  is schematically depicted with the housing  16  attached to the neck of a patient, just below his or her ear  28 , with each of the treatment devices  18 ,  20  and  22  positioned at a selected auricular point on the exterior surface of the skin of the ear  28 . Each of the components of the auricular device  10  is described separately below, followed by a discussion of the operation of the device  10 . 
     The mounting pad  12  may be a standard electrode of the type employed in electrocardiogram machines including a circular-shaped section  30  of flexible plastic which mounts the reference electrode  14 . The plastic section  30  has adhesive on one side that may be placed against the skin of the patient, preferably on the neck just below the ear  28  as noted above. As discussed in more detail below, the mounting pad  12  functions to support the housing  16  and its reference electrode  14  provides a ground connection for electronic circuit located within the housing  16 . 
     As best seen in  FIG. 2 , each of the treatment devices  18 - 20  comprises a casing  31  within which a magnet  32  or metallic element having magnetic properties is mounted. The term “metallic element” as used herein refers to an alloy containing a magnetic metal such as iron, nickel or cobalt which is attracted to a magnet. The wire  24  is coupled to the casing  31  so that it electrically contacts the magnet  32 , for purposes discussed in detail below. 
     As noted above, each of the treatment devices  18 - 22  is positioned at a selected auricular point on the ear  28  so that they may deliver a pulsed voltage for treatment purposes. With reference to  FIGS. 3 and 4 , two methods are contemplated in this invention for positioning the treatment devices  18 - 22 . In the embodiment depicted in  FIG. 3 , a permanent, backing magnet  34  is placed on the side of the ear  28  opposite one of the treatment devices  18 - 22 , e.g. the treatment device  18  as illustrated in  FIG. 3 . Preferably, the backing magnet  34  is held in place on the ear by a strip  36  of medical tape, such as “Medipore” surgical tape commercially available from the Minnesota Mining and Manufacturing Company of St. Paul, Minn. The metallic element or magnet  32  of the treatment device  18  is held in place on the ear  28  by the magnetic field produced by the permanent, backing magnet  34  located on the opposite side of the ear  28 . 
     Alternatively, a needle assembly  38  is employed to retain the treatment devices  18 - 22  in place. As shown in  FIG. 4 , each needle assembly  38  includes a needle  40  having a shaft  42  with a point  44  and one end and a plate  46  connected at its opposite end. The plate  46  has a seat  48  that receives a cover  50  forming a cavity  52  within which a permanent magnet  54  is mounted. The needle  40  is extended into the ear  28  so that the plate  46  rests against one side of the ear  28 . The size of needle  40  and its depth of penetration into the ear  28  are exaggerated in  FIG. 4  for purposes of illustration. If desired, a strip of surgical tape (not shown) may be placed along the plate  46  to help hold the needle  40  in place. The cover  50  encloses the end of the plate  46  and permanent magnet  54 , but it is relatively thin and allows the magnetic field produced by the permanent magnet  54  to attract the treatment device  18  which rests against the outside surface of the cover  50 . 
     It is contemplated that the backing magnet  34  and needle assembly  38  may be positioned at the appropriate auricular point on the ear  28  by a physician or other health care professional. Both are intended to remain in position during the useful life of the device  10  of this invention while allowing the patient to shower, wash his or her hair etc. without damaging either. As discussed below, the treatment device  18  may be readily removed from the opposite side of the ear ( FIG. 3 ) or from the cover  50  of needle assembly  38  ( FIG. 4 ) when the device  10  is not operating or when the patient wishes to shower etc. 
     Referring now to  FIGS. 5-7 , the circuit housing  16  of this invention is shown in more detail. In one presently preferred embodiment, the housing  16  comprises a base  56 , a cap  58  and a middle plate  60  connected between the base  56  and cap  58 . The base  56  is formed with a central bore  62  which engages the reference electrode  14  of the mounting pad  12 , as schematically shown in  FIG. 1 , and a recess  64  in its side edge. The middle plate  60  has a mating recess  66  along its side edge, which, when the base  56  and middle plate  60  are connected, forms a port  68  with the recess  64  in base  56 . The port  68  connects to a coupler  70  at the end of wire  24 , as seen in  FIG. 1 , or to a serial interface described below in connection with a discussion of the electronic circuit of device  10 . As best seen in  FIG. 7 , the middle plate  60  is formed with an opening  72  at either end, each of which mounts a battery (not shown). A central area of the middle plate  60  mounts a printed circuit board  74  which carries the electronic circuit of device  10  schematically illustrated in  FIG. 8 . The base  56  and cap  58  capture and support the middle plate  60  between them, as seen in  FIG. 6 . 
     A schematic, block diagram of the electronic circuit  76  employed in the auricular device  10  of this invention is shown in  FIG. 8  wherein each block is representative of a circuit element. The block identified with the reference  78  is denoted as a “power source,” which may comprise one, two or more batteries. The power source  78  is coupled to a power converter  80 , which, in turn, is coupled to a microprocessor  82 , to an adjustable voltage power converter and current limit  84 , and, to an adjustment module  86 . The adjustment module  86 , having schematically depicted “up” and “down” controls  88 ,  90 , respectively, is coupled to the power convertor  80 . A buzzer driver  89  is coupled to the microprocessor  82  and to a buzzer  92 . Both the adjustable voltage power convertor and current limit  84  and the microprocessor  82  are coupled to an output driver  94 , and the adjustable voltage power convertor and current limit  84  is coupled to the adjustment module  86 . The output driver  94 , in turn, is coupled to the wire  24  and to the reference electrode  14  of the mounting pad  12  which functions as a ground or reference for the electronic circuit  76 . A serial interface  96  may be coupled to the microprocessor  82 , as discussed below. 
     The auricular device  10  is operated as follows. Initially, auricular points on the outer part of the ear  28  are identified depending upon the symptoms or other conditions of a particular patient. The identification of auricular points and/or their correlation with different health conditions forms no part of this invention and is therefore not discussed herein. However, once such points are identified by a health care professional, the device  10  of this invention is employed to deliver a pulsed voltage to such points. 
     As noted above, the mounting pad  12  is adhered to the neck of a patient, preferably in the area beneath the ear  28 , with the reference electrode  14  exposed. The housing  16  may be removably attached to the mounting pad  12  by insertion of the reference electrode  14  though the central bore  62  in the base  56  of the housing  16 . The output driver  94  of electronic circuit  76  is connected to each of the treatment devices  18 ,  20  and  22  by the wire  24 . As discussed above, each treatment device  18 - 20  is held in position at one of the selected auricular points on the ear  28  either by a backing magnet  34  or a needle assembly  38 . 
     One important aspect of this invention is the removable nature of both the housing  16  and the treatment devices  18 - 22  from their positions on the patient. Water from bathing or other sources can damage the electronic circuit  76  and treatment devices  18 - 22 . Before taking a shower, for example, the housing  16  may be removed from the mounting pad  12  and the treatment devices  18 - 22  may be disengaged from the backing magnets  34  or needle assemblies  38 . The wire  24  may remain attached to the housing  16  or unplugged at the connection of the coupler  70  at one end of wire  24  to the port  62  in housing  16 . While the backing magnets  34  and needle assemblies  38  would remain in place, they are not harmed in any way by contact with water. Once the patient has dried from a shower or other exposure to water, he or she may reinsert the housing  16  onto the mounting pad  12  and reposition the treatment devices  18 - 22  relative to the backing magnets  34  or needle assemblies  38 , as described above, in order to continue treatment without the assistance of a physician or other health car professional. 
     The circuit  76  of this invention functions to produce a pulsed, low voltage output to stimulate the auricular points at which the treatment devices  18 - 22  are located. Power is supplied from the power source  78  via the power convertor  80  to the microprocessor  82  which has a self-contained circuit (not shown) that generates an output pulse train in the form of a square wave having alternately a plus and minus component represented by the lines  98  and  100  from microprocessor  82  connected to the output driver  94 , and lines  102  and  104  output from the output driver  94 . One of the lines  102 ,  104  is connected to the wire  24 , and the other of the lines  102 ,  104  is coupled to the ground electrode  14  of mounting pad  12  to act as a reference or ground. The magnitude of the voltage output from the output driver  94  is controlled by the adjustable voltage power convertor and current limit  84  and the adjustment module  86 . In the presently preferred embodiment, a manually operated dial or switches associated with the adjustment module  86 , which are schematically illustrated in  FIG. 8  as the “up” control  88  and “down” control  90 , may be operated to adjust the voltage up or down depending upon whether the treatment devices  18 - 22  are located on the ear  28  using a backing magnet  34  or a needle assembly  38 . It has been found that less voltage is required for effective treatment, and also desired for comfort purposes, when using a needle assembly  38  to retain a treatment device  18 - 22  in place compared to a backing magnet  34 . Preferably, when using a needle assembly  38  the voltage output to the treatment devices  18 - 22  is in the range of about 4 volts to 6 volts, whereas the voltage output to treatment devices  18 - 22  when using a backing magnet  34  is in the range of about 9 volts to 24 volts. 
     The circuit  76  is designed to operate for a one to three hour treatment cycle, automatically shut down for a similar period of time and then start again for another treatment cycle. The buzzer driver  89  and buzzer  92  are provided to notify the patient of these events. The buzzer driver  89  consists of a timed oscillator-driven piezoelectric element designed for minimal power consumption. The microprocessor  82  controls the buzzer driver  89  such that it is activated at the beginning of each treatment cycle to cause the buzzer  92  to produce a number of short sound bursts, e.g. three, for example. This alerts the patient to the onset of a treatment cycle. The removable nature of the components of this invention allows the patient, if desired, to detach the housing  16  from the mounting pad  12  and the treatment devices  18 - 22  from the ear  28  during periods in between treatment cycles for enhanced comfort. The housing  16  and treatment devices  18 - 22  may be repositioned when the patient is alerted by the buzzer  92  to the start of another treatment cycle, in the manner described above. 
     The embodiment of the invention discussed above provides the patient with the ability to adjust the voltage output to the treatment devices  18 - 22  by manipulation of the “up” and “down” controls  88 ,  90 . It should be understood that such voltage levels could be set at the factory, allowing for no adjustment by the patient or healthcare professional, in which case the housing  16  and treatment devices  18 - 22  would be intended for use only with backing magnets  34  or with needle assemblies  38  depending on the magnitude of the set voltage as discussed above. 
     It is contemplated that in some instances the healthcare professional may wish to make changes to the voltage output to the treatment devices  18 - 22 , such as the pulse frequency, the pulse width, the provision of sequential pulses, the output of more than one pulse at a time and the like. These variations in the operation of device  10  are made possible using the serial interface  96 . The term “serial interface” as used herein refers to device that may be coupled to the electronic circuit  76  via port  62 , and to a computer or the like having software capable of being downloaded to the microprocessor  82  of the circuit  76 . Once downloaded to the microprocessor  82 , such software would control the voltage output to the treatment devices  18 - 22 , as desired. 
     While the invention has been described with reference to a preferred embodiment, it should be understood by those skilled in the art that various changes may be made and equivalents substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. 
     For example, three treatment devices  18 ,  20  and  22  are depicted in the drawings but it should be understood that a different number of such treatment devices may be employed, as desired. 
     Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.