Abstract:
A portable, wearable device for managing pain and promoting healing, a management assembly including such a device, and a method of using the same. The device includes a housing defining a cavity; a microprocessor situated within the cavity; a power source operatively connected with the microprocessor; and a pair of electrodes. The electrodes are mounted in apertures in a bottom wall of the housing and extend for a distance there beyond. One or more mounting assemblies are used with the device to provide a management assembly. The mounting assembly may be a strap having a retaining ring into which the device fits, or an adhesive patch configured to receive the device. The device is engaged with the mounting assembly and then positioned adjacent the patient&#39;s skin. When activated, the device generates a current which passes from one electrode through the patient&#39;s skin to the other electrode thereby mitigating pain.

Description:
BACKGROUND OF THE INVENTION 
     1. Technical Field 
     This invention relates generally to medical devices. More particularly, this invention relates to devices used to mitigate or control pain and promote healing. In particular, the invention relates to a device for delivering a low frequency, low voltage electrical charge to a patient&#39;s skin, which device comprises a portable, self-contained unit with built-in electrodes which is engaged in a mounting assembly and worn adjacent the patient&#39;s skin so that it is suitably positioned to deliver the charge thereto. 
     2. Background Information 
     Transcutaneous electrical neural stimulation (TENS) devices help manage pain utilizing electrical charge. TENS devices utilize FDA approved approaches to manage and relieve pain by cutting off pain signals before they have time to reach the brain. This form of pain management is also believed to release natural pain-fighting endorphins. A TENS device may be worn all day or on an as-needed basis, dependent upon what route the patient and their physician may choose to take. 
     There are many TENS units on the market today such as the EV807 which is accessible at the website http://mywellcare.ca/tens_units/ev-807p_digital_tens_ems_n.m.e.s These units are typically utilized by physical therapists to help patients recover from injuries. All of these units tend to work in substantially the same way and come with one or two channels. Each channel has two electrodes connected to the main unit by means of wires. The electrodes have a sticky-pad which is adhered to the patient&#39;s skin. The electrodes get placed on the patient&#39;s skin some distance apart from each other so that the current generated by the main unit of the device is able to flow through the body tissue. 
     Presently known devices, while they work well, have a downfall in that their wires and their bulk are not ideal for daily use if the patient is actively mobile. Additionally, many of these devices are fairly complex, making them more difficult for some patients to use by themselves. 
     There is therefore a need in the art for an improved device that is suitable for patients to utilize themselves in order to help manage their pain and help speed recovery from injury. 
     SUMMARY 
     A portable, wearable device for managing pain and promoting healing, a pain management assembly including such a device, and a method of using the same is disclosed. The device is a small and completely self-contained device including a housing defining a cavity; a microprocessor situated within the cavity; a power source operatively connected with the microprocessor; and a pair of electrodes. The electrodes comprise two spaced-apart metal contact plates which are mounted in apertures in a bottom wall of the housing. At least a portion of each contact plate extends for a distance outwardly beyond the housing&#39;s bottom wall. An electrical charge is delivered to the contact plates which thereby effectively become electrodes which deliver the charge to a patient&#39;s skin. The size of the device and lack of wires extending outwardly from its housing make the device easier for a patient to use themselves than was the case with previously known devices. 
     One or more mounting assemblies are used with the device to provide a management assembly. The mounting assembly may be a strap having a retaining ring into which the device fits, or an adhesive patch configured to receive the device. This renders the device fully portable and enables the patient to be reasonably active while wearing the device and simultaneously receiving treatment therewith. The device is engaged with the mounting assembly and then positioned adjacent the patient&#39;s skin. When activated, the device generates a current which passes from one electrode through the patient&#39;s skin to the other electrode thereby mitigating pain. 
     The device is thus more capable of being used discretely by a patient than was the case with previously known TENS devices. Additionally, since the present device does not require wires that connect the device to remotely placed electrodes, the present device is less prone to damage during use and easy to position on the body. The pain management assembly preferably is provided in a kit that includes the device itself with a variety of different mounting assemblies. The enables the patient to select the most appropriate mounting assembly for the region of the body to which they wish to apply the electrical charge. Thus, for a example, the kit may include the device, a strap type mounting assembly for securing the device to an arm or leg, and a variety of differently configured adhesive patches which can be selected based on the part of the body to which they need to be adhered. 
     The disclosed device, which is a small, compact, portable and self-contained transcutaneous electrical neural stimulation (TENS) device operates at a much lower voltage than previously known device—preferably from about 20V to 25V and delivers around 900 μA (900 micro amps) of current. A typical previously known TENS unit operates at a voltage of up to 50 volts, i.e., about twice as much voltage as the present device; and delivers around 100 mA (100 milliamps) of current, i.e., about one hundred times more amps than the present device. 
     The earth&#39;s electromagnetic field generates frequencies of around 10 Hz. Humans exhibit ALPHA brainwaves between 7 and 12 Hz. It has been postulated that the body heals better if it is subjected to frequencies that are in the same frequency range as the earth&#39;s electromagnetic field and those of human brain waves. The present device is configured so that it will generate frequencies in this desired range. This is unlike previously known TENS units Because the present device is so portable, it can be worn daily, so the device&#39;s beneficial effects to tissues are able to take place over a period of time. 
     In one aspect, the invention may provide a device for managing pain and promoting healing, said device comprising:
         a housing;   a cavity defined in the housing;   a microprocessor provided within the housing&#39;s cavity;   a power source operatively connected with the microprocessor; and   a pair of electrodes mounted on the housing and being operatively connected with the microprocessor and the power source; said electrodes being configured to deliver a charge to a patient&#39;s skin.       

     In another aspect, the invention may provide a pain management and healing assembly comprising:
         a device including:   a housing;   a cavity defined in the housing;   a microprocessor provided within the housing&#39;s cavity;   a power source operatively connected with the microprocessor; and   a pair of electrodes mounted directly on the housing and being operatively connected with the microprocessor and the power source; and   a mounting assembly configured to engage the device and retain the device adjacent a patient&#39;s skin; and wherein the device is operable to cause current from the electrodes to flow through the patient&#39;s skin.       

     In yet another aspect, the invention may provide a method of relieving pain and promoting healing; said method including the steps of: 
     providing a portable transcutaneous electrical neural stimulation (TENS) device having a housing; a cavity defined in the housing; a microprocessor provided within the housing&#39;s cavity; a power source operatively connected with the microprocessor; and a pair of electrodes mounted directly on the housing and being operatively connected with the microprocessor and the power source; and 
     engaging the TENS device in a mounting assembly; 
     positioning the TENS device adjacent the patient skin and retaining the same there against by means of the mounting assembly; and 
     generating a current through the patient&#39;s skin using the electrodes. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       A sample embodiment of the invention, illustrative of the best mode in which Applicant contemplates applying the principles, is set forth in the following description, is shown in the drawings and is particularly and distinctly pointed out and set forth in the appended claims. 
         FIG. 1  is a perspective view of a healing disc in accordance with an aspect of the present invention; 
         FIG. 2  is a top view of the healing disc; 
         FIG. 3  is a side view of the healing disc; 
         FIG. 4  is a bottom view of the healing disc; 
         FIG. 5  is an exploded perspective view of the healing disc; 
         FIG. 6  is a perspective view of a first mounting assembly showing the healing disc separated therefrom and ready for insertion into the assembly; 
         FIG. 7  is a perspective top view of the first mounting assembly with the healing disc engaged therewith; 
         FIG. 8  is a perspective view showing the first mounting assembly with the healing disc engaged therewith worn on a patient&#39;s arm; 
         FIG. 9  is a perspective top view of a second mounting assembly with the healing disc engaged therewith; 
         FIG. 10  is a perspective view showing the second mounting assembly with the healing disc engaged therewith being worn on a patient&#39;s arm; 
         FIG. 11  is a perspective top view of a third mounting assembly with the healing disc engaged therewith; and 
         FIG. 12  is a perspective view of the third mounting assembly with the healing disc engaged therewith being worn on a patient&#39;s back. 
     
    
    
     Similar numbers refer to similar parts throughout the drawings. 
     DETAILED DESCRIPTION 
     Referring to  FIGS. 1-12  there is shown a healing disc or device in accordance with an aspect of the present invention, generally indicated at  10 . 
     Disc  10  includes an upper housing  12  and a lower housing  14  which are configured to matingly engage each other and define an interior cavity (not shown but formed between the upper and lower housing&#39;s interior surfaces). Various components are housed within this cavity, as will be described hereafter. 
     Upper and lower housings  12 ,  14  preferably are fabricated from polycarbonate plastic, although any other suitable materials may be used instead. Upper housing  12  is gently curved toward its outer edge (as shown at  12   b  in  FIG. 5 ) so that disc  10  does not present any sharp edges which may injure the patient. Upper and lower housings  12 ,  14  together form a unit that is generally circular in shape when viewed from the top or bottom and is relatively thin. Disc  10  preferably has a diameter of approximately 1½ inches and the overall thickness of disc  10  is about 3/62 inch. 
     Upper housing  12  has an exterior surface  12   a  and an interior surface (not shown). A generally circular central aperture  18  is defined in upper housing  12  and extends between the exterior and interior surfaces thereof. Upper housing  12  further defines four generally rectangular slots  20  which are spaced outwardly from aperture  18  and are preferably equidistant from each other. Slots  20  extend between the exterior and interior surfaces of upper housing  12  and are arranged to circumscribe aperture  18 . Any other configuration of aperture  18  and slots  20  may be utilized. 
     Lower housing  14  has an exterior surface  14   a  and an interior surface  14   b . A pair of spaced-apart apertures  22  is defined in a bottom wall  14   c  of lower housing  14 . Apertures  22  extend between the exterior and interior surfaces  14   a ,  14   b  of lower housing  14  and preferably are generally semi-circular in shape. A hole  24  is defined in a side region of lower housing  14  and extends between the exterior and interior surfaces  14   a ,  14   b . A pair of posts  26  extends upwardly from the interior surface of bottom wall  14   c . Posts  26  and disposed generally at right angles to bottom wall  14   c  and extend toward upper housing  12  when upper and lower housings  12 ,  14  are engaged with each other. Disc  10  further includes a pair of contact plates  32 , which are complementary in shape and size to apertures  22  in lower housing  14 . Contact plates  32  are engaged in apertures  22  so that they project for a slight distance outwardly beyond the exterior surface of bottom wall  14   c  of lower housing  14 . This ensures that plates  32  will contact the patient&#39;s skin when disc  10  is worn on the body, as will be described later herein. Contact plates  32  are electrodes that will pass a current to the patient&#39;s skin in order to block pain. Contact plates  32  preferably are fabricated from metal. In previously known TENS units, the electrodes are connected via wires to components within the housing and those wires extend for a distance outside of the unit&#39;s housing. Disc  10  is differently configured in that electrodes  32  are mounted directly to housing  12 / 14  and disc  10  is free of any wires which extend outwardly from the housing. 
     A printed circuit board (PCB)  36  is provided within the housing formed by upper and lower housing  12 ,  14 . PCB  36  is planar and generally circular in shape, and defines a pair of holes  38  therein and through which posts  26  extend to retain PCB  36  in place. PCB  36  is operatively connected with contact plates  32  via conductive springs  40 . A USB charger  42  extends through hole  24  in lower housing  14  and is operatively connected with PCB  36 . 
     A power source is also provided within disc  10 . As shown in  FIG. 5 , this power source comprises two rechargeable batteries  34 , each of which fits inside a recessed region of one of contact plates  32 . Batteries  34  are operatively connected to all components within disc  10  that require power. Although not illustrated herein, it will be understood that batteries  34  may be recharged by plugging a cord into a wall transformer or into a USB port.  FIG. 5  shows disc  10  including USB charger  42  which will permit disc  10  to be recharged by plugging it into a computer. Batteries  34  are sized so that together they will provide an output voltage of from about 20V to about 25V and an amperage of about 900 micro amps or less. Disc  10  is able to selectively generate current at four different frequencies, namely, about 4 Hz, 6.8 Hz, 7.83 Hz, and 11 Hz. It will be understood that only one battery could be utilized in disc  10  or more than two batteries could be utilized therein. Furthermore, any other suitable power source may be used instead of batteries  34 . 
     PCB  36  also includes a plurality of LEDs  44 . Disc  10  further includes four indicator lightpipes  46 , each of which being shaped and sized so that a portion thereof is received through one of slots  20  in upper housing  12 . Each indicator lightpipe  46  is positioned to be disposed over one of LEDs  44 . Each LED  44  positioned adjacent one of the indicator lightpipes  46  is able to be activated to indicate the one of four output frequencies that is being generated by device. As shown in  FIG. 2 , upper housing  12  preferably includes an indicator  47  are associated with each lightpipe  46 . Indicators  47  identify the frequency being outputted by disc  10  when the associated lightpipe  46  is illuminated. The indicators  47  may take any form.  FIG. 2  illustrates numerical markings placed on exterior surface  12   a  of upper housing  12 . Alternatively, indicators  47  may be digital readouts displayed on a screen window provided on upper housing  12 . 
     A button switch  48  is provided centrally on PCB  36  and a button lightpipe  50  is disposed over button switch  48  and over two LEDs  44 . A button bezel  52  is disposed over button lightpipe  50 . Bezel  52  is shaped and sized so that a portion thereof extends through aperture  18  in upper housing  12 . Bezel  52  defines a slot  54  therein. A portion  50   a  of button lightpipe  50  extends through slot  54  in bezel  52 . Bezel  52  preferably is fabricated from an elastomer. Bezel  52  is engaged with button switch  48 . When depressed, button switch  48  will switch the device on or off and portion  50   a  of button lightpipe  50  will light up (if the device is on) or will cease to be illuminated (if the device is switched off). 
     PCB  36  includes a microprocessor and other electronics similar to a TENS device. Microprocessor includes programming which will control the operation of disc  10 . In particular, the programming controls the charge outputted by contact plates  32  and controls the timing and duration of that output. Preferably, the microprocessor activates contact plates  32  for repeating cycles of 15 seconds on followed by 5 seconds off, i.e., 15 seconds of delivering a charge to the patient&#39;s skin followed by 5 seconds of no charge being delivered to the patient&#39;s skin. This on/off cycle is repeated for a pre-determined time period, preferably 20 minutes and then disc  10  shuts off automatically. 
     As indicated previously, button switch  48  is used to switch disc on and off. The patient will depress bezel  52  and hold for 2 seconds to step through four standard pre-set frequencies. When the desired frequency is indicated by the illumination of the LED  44  adjacent the indicator  47  which represents that desired frequency, the patient will stop depressing bezel  52 . Disc  10  will then generate the frequency indicated by the illuminated LED  44  for the 20 minute cycle and will then shut off automatically. When the patient next switches disc  10  on, the previously set frequency is remembered and the device will operate at that frequency. If the patient wishes to change the frequency, they will continue to hold down the button switch  48  to cause the device to step through the pre-set frequencies as previously described and will stop depressing switch  48  when the desired frequency is reached (i.e., when the LED  44  adjacent the appropriate indicator  47  is illuminated). 
     Disc  10  is configured to be worn adjacent the patient&#39;s skin.  FIGS. 6 through 12  show various ways in which disc  10  can be retained adjacent a patient&#39;s skin.  FIGS. 6-8  show a first pain management assembly which comprises a first mounting assembly and the disc  10 . This first mounting assembly is a holder  58  which is configured to wrap around and be secured to a patient&#39;s arm  58  or leg (not shown). Holder  56  includes a strap  60  configured to encircle the arm  58  or leg. Strap  60  may be fabricated from an elastic type material so that it can be stretched in order to place it on the patient&#39;s arm or leg. Alternatively, strap  60  may be fabricated from a non-elastic material and be provided with a locking mechanism (not shown) which is operable to secure strap  60  to arm  58  (or leg). Holder  56  further includes a retainer ring  62 . Retaining ring  62  includes a peripheral wall  62   a  which bounds and defines a central aperture  64 . Aperture  64  is slightly larger in diameter than the exterior diameter of lower housing  14 . A lip (not numbered) formed on the upper edge of retainer ring  62  bounds aperture  64  and is provided to keep disc  10  retained therein, as will be further described. A pair of C-shaped flanges  66  extends outwardly from peripheral wall  62   a  and each flange  66  is disposed generally at right angles to wall  62   a . An slot  68  is defined between each flange  66  and peripheral wall  62   a  of retaining ring  62 . Each end of strap  60  is threaded through one of slots  68  and is secured back upon itself. Disc  10  is inserted into holder  56  from the bottom as indicated by the arrow shown in  FIG. 6 . Disc  10  snap-fits into retainer ring  62  and is retained therein by frictional contact with the interior surface of wall  62   a  and by the lip which bounds aperture  64 . Although not numbered, it can be seen that several ridges are provided on the interior surface of wall  62   a  to aid in frictionally retaining disc  10  therein. When disc  10  is retained in ring  62 , the bottom wall  14   c  of lower housing  14  is positioned so that contact plates  32  will project beyond a lower edge  62   b  of ring  62  so that plates  32  are able to contact the patient&#39;s skin. Strap  60  is placed around the patient&#39;s arm  58  and is moved along the arm to the position adjacent where the patient is experiencing pain. The patient will then depress bezel  52  to activate switch  48  and switch disc  10  on, holding bezel  52  down to select the desired frequency, and then disc  10  will generate current and deliver a charge to the skin below disc  10  via electrodes  32  as has been previously described. When disc  10  switches off automatically, the patient may continue to wear the assembly until they next wish to administer another treatment. If the patient wishes to remove disc  10  from holder  58  they will remove strap  60  from their arm and simply apply pressure to the upper surface  12   a  of upper housing  12  and push disc  10  out of retaining ring  62 . 
       FIGS. 9 and 10  show a second pain management assembly in accordance with an aspect of the invention. This second pain management assembly includes a second mounting assembly and the disc  10 . The second mounting assembly comprises an adhesive patch  70  which is configured to engage and retain disc  10  adjacent the patient&#39;s skin. Patch  70  is generally circular and includes an upper surface  70  and a lower surface (not shown). An adhesive layer is applied to the lower surface of patch  70 . A central aperture  72  is defined in patch  70  and is dimensioned so that it is slightly smaller than the exterior diameter of disc  10 . When disc  10  is engaged in patch  70 , a portion of the lower surface of patch  70  contacts an upper exterior surface  12   a  of upper housing  12  of disc  10  and the adhesive layer on the lower surface of patch  70  adheres disc  10  to patch  70 . Patch  70  extends for a distance outwardly beyond disc  10  and this additional portion of patch  70  is placed in contact with the patient&#39;s skin and adheres thereto. 
     Patch  70  preferably includes a plurality of slits  74  which are spaced a distance outwardly of aperture  72 . Slits  74  extend radially outwardly away from aperture  72  and are spaced apart from each other. Slits  74  are provided so that patch  70  is able to conform to the shape of the part of the body to which the patient wishes to apply patch  70 . This configuration of patch  70  enables the patient to position the disc  10  adjacent almost any injured part of the body.  FIG. 11  illustrates patch  70  with disc  10  engaged therewith adhesively secured to the upper region of a patient&#39;s arm  76 . 
       FIGS. 11 and 12  show a third pain management assembly comprising a third embodiment of a mounting assembly which is able to engage disc  10  and to retain the same adjacent a patient&#39;s skin. The third embodiment of the mounting assembly comprises an adhesive patch  78 . Patch  78  is generally H-shaped and includes a central region  78   a  from which extend outwardly pairs of legs  78   b ,  78   c ,  78   d , and  78   e . Preferably, central region  78   a  is generally circular in shape and defines an aperture  80  therein. Aperture  80  extends between an exterior surface and an interior surface of patch  78  and is sized to be just slightly smaller in diameter than disc  10 . An adhesive layer (not shown) is applied to interior surface of central region  78   a  and to the interior surfaces of legs  78   b ,  78   c ,  78   d , and  78   e . Thus, a portion of patch  78  overlays portion of the exterior surface of upper housing  12  of disc  10  and the adhesive layer disposed between patch  78  and disc  10  keeps disc  10  engaged with patch  78 . The adhesive layer on the legs  78   b ,  78   c ,  78   d , and  78   e  retain the disc  10  on the patient&#39;s skin.  FIG. 12  shows patch  78  being utilized to secure disc  10  to a patient&#39;s back  82 . 
     It will be understood that with both patch  70  and patch  78  the adhesive regions thereof are preferably initially covered with a non-adhesive protective layer that is peeled off immediately prior to use. Patches  70  and  78  are used in much the same manner as an adhesive plaster. If patch  70  or  78  is to be applied in a region of the patient&#39;s body that is easily accessed once applied, disc  10  may be activated (as previously described) after application of the patch. If, patch  70  or  78  is to be applied in a region of the patient&#39;s body that will not be easily accessed after application of the patch, then disc  10  is activated prior to application of the patch on the body. Once the patient is finished treatment, the adhesive patch  70  or  78  is simply pulled off the skin and disposed of. 
     It will be understood that disc  10  could be supplied in a kit which includes the first mounting assembly  58  and one or both of the second mounting assembly  70  and third mounting assembly  78 . This kit would enable a patient to select which mounting assembly is most appropriate for using for treatment of a particular region of their body. The kit may include additional or other differently configured mounting assemblies which will enable the patient to wear disc  10  adjacent their skin. 
     In the foregoing description, certain terms have been used for brevity, clearness, and understanding. No unnecessary limitations are to be implied therefrom beyond the requirement of the prior art because such terms are used for descriptive purposes and are intended to be broadly construed. 
     Moreover, the description and illustration of the preferred embodiment of the invention are an example and the invention is not limited to the exact details shown or described.