Abstract:
A method for combining the effective modalities of electrotherapy and phototherapy is provided. A medical electrode assembly is substantially transparent or translucent to visible, infrared and/or ultraviolet light so that light rays emitted by a phototherapy device can shine through and pass transversely across every layer of the medical electrode assembly to impinge upon the skin of the patient to which the assembly is attached. This includes an area of skin located directly underneath the medical electrode assembly and thereby enables the combination therapy to be achieved

Description:
BACKGROUND OF THE INVENTION 
       [0001]    The present invention relates to the therapeutic application of electrotherapy and the therapeutic application of phototherapy to a patient, and more particularly, the present invention relates to a medical electrode assembly for use in applying these therapies and a method in which the therapies can be applied to a patient simultaneously. 
         [0002]    Phototherapy and electrotherapy are two very different therapies. Phototherapy is a process where light and/or laser photons are directed onto the skin of the patient and enter the tissue of the skin of the patient for therapeutic purposes. The phototherapy light source is typically provided by a pad with a cluster of LEDs or a probe with LEDs and/or lasers or other light source. U.S. Patent Application Publication No. 2004/0166146 A1 of Holloway et al. provides an example of the use of phototherapy. 
         [0003]    In contrast, electrotherapy is the therapeutic application of electricity to the body. Stimulation wires have one end electrically connected to an electrical stimulation machine and the other end electrically connected to the skin of the body. Single or multiple channels with various frequencies can be utilized. Medical electrodes assemblies are used to connect the stimulation wires to the skin of the patient&#39;s body and are typically made of at least three separate layers. The three layers include an adhesive layer used to attach the medical electrode assembly to the body, a black rubber layer secured over the adhesive layer, and a foam or cloth backing layer attached to the rubber layer. Such medical electrode assemblies are not transparent with respect to visible, ultraviolet or infrared light, and one cannot visually see the skin of the patient through the electrode assembly. 
         [0004]    U.S. Pat. Nos. 5,450,845 and 5,785,040 issued to Axelgaard provide examples of the construction of a typical medical electrode assembly. Also see U.S. Patent Application Publication No. 2005/0010161 A1 of Sun et al. for applying electricity or light to the skin of a patient. Further, see U.S. Patent Application Publication No. 2002/0068861 A1 of Yang and U.S. Pat. No. 4,539,995 issued to Segawa, U.S. Pat. Nos. 4,674,511 and 4,838,273 issued to Cartrnell, U.S. Pat. No. 4,685,467 issued to Cartnell et al., U.S. Pat. No. 4,800,887 issued to Shigeta et al., U.S. Pat. Nos. 5,265,579 and 5,571,165 issued to Ferrari, U.S. Pat. No. 5,356,428 issued to Way, U.S. Pat. No. 5,499,628 issued to Wright, and U.S. Pat. No. 6,600,957 B2 issued to Gadsby for medical electrode assemblies that are radiolucent or transparent with respect to x-rays. U.S. Pat. No. 4,300,575 issued to Wilson, U.S. Pat. No. 6,907,299 B2 issued to Han, U.S. Pat. No. 6,999,822 B2 issued to Koike, U.S. Pat. No. 4,391,278 issued to Cahalan et al., U.S. Pat. No. 4,694,835 issued to Strand, U.S. Pat. Nos. 5,133,356 and 5,226,225 issued to Bryan et al., and U.S. Pat. No. 5,215,087 issued to Anderson et al. and U.S. Patent Application Publication No. 2006/0183989 A1 of Healy disclose other medical electrode assemblies. 
         [0005]    While the medical electrode assemblies and/or methods of use disclosed in the above referenced patents and published applications may function in a satisfactory manner for their intended purposes, there remains a need for a method of treatment and medical electrode assembly enabling the simultaneous therapeutic applications of electrotherapy and phototherapy to a patient. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention provides a method for combining the two above referenced very effective modalities of electrotherapy and phototherapy. It is submitted that the combination of electrotherapy and phototherapy will have advanced synergistic effects since these therapies have proven therapeutic effectiveness when used alone. The present invention also provides a medical electrode assembly. Substantially the entire medical electrode assembly is transparent or translucent so that the radiation or light rays emitted by a phototherapy device shines and passes through the medical electrode assembly and is applied to the skin of the patient, including skin located directly underneath the medical electrode assembly, to achieve the combination therapy. 
         [0007]    Preferably, the medical electrode assembly according to the present invention comprises or consists of an upper flexible gel layer secured over a lower flexible gel layer with an exposed end of an electrically-conductive lead wire sandwiched therebetween. The lower flexible gel layer is electrically conductive for electrically coupling the assembly to the skin of the patient and is self-adhesive for adhering the assembly to the skin of the patient. Both the upper and lower flexible gel layers are transparent or translucent relative to visible, ultraviolet and/or infrared light to permit passage or transmission of visible, ultraviolet and/or infrared light rays through the assembly. 
         [0008]    Preferably, the method of therapy using the medical electrode assembly of the present invention comprises the steps of adhering the medical electrode assembly to the skin of patient and applying electrotherapy to a patient via the medical electrode assembly while simultaneously applying phototherapy to the skin of the patient with a light source. The step of applying phototherapy preferably includes directing visible, ultraviolet and/or infrared light emitted by the phototherapy light source through the medical electrode assembly and onto the skin of the patient including the skin of the patient located directly underneath the medical electrode assembly. 
         [0009]    In one contemplated embodiment, the light source emits electromagnetic radiation within a wavelength range of 280 nm to 50,000 nm, and the medical electrode assembly includes upper and lower flexible transparent layers that are transparent or translucent to, and permit passage of, electromagnetic radiation of a wavelength of 280 nm to 50,000 nm. In another contemplated embodiment, the light source emits electromagnetic radiation within a wavelength range of 400 nm to 1,000 nm, and the upper and lower ble transparent layers are transparent or translucent to, and permit passage of, electromagnetic radiation of a wavelength of 400 nm to 1,000 nm. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    The features and advantages of the present invention should become apparent from the following description when taken in conjunction with the accompanying drawings, in which: 
           [0011]      FIG. 1  is a perspective view of a series of separate medical electrode assemblies adhered to a release sheet according to the present invention; 
           [0012]      FIG. 2  is a perspective view of a single medical electrode assembly adhered to the skin of a patient according to the present invention; 
           [0013]      FIG. 3  is a cross-sectional view of the medical electrode assembly taken along line  3 - 3 ; 
           [0014]      FIG. 4  is a schematic view of a first embodiment of a combination of a medical electrode assembly and a light source according to the present invention; and 
           [0015]      FIG. 5  is a schematic view of a second embodiment of a combination of a medical electrode assembly and a light source according to the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0016]      FIGS. 1-3  illustrate the medical electrode assembly  10  according to the present invention. The assembly includes dual layers,  12  and  14 , that can be provided as patches, pads, or the like and be of substantially any size desired. The assembly  10  can include more than two layers; however, in its preferred embodiment, the assembly  10  of the present invention consists of a pair of opposed continuous layers. A free exposed end  16  of carbon fiber, steel fiber, copper fiber or any other type of electrically-conductive stimulation lead wire  18  is attached to the assembly  10  by being secured and sandwiched between the dual layers,  12  and  14 . 
         [0017]    Both of the dual layers,  12  and  14 , are transparent or translucent to visible light, ultraviolet light, and/or infrared light. For example, with respect to the preferred embodiment, the dual layers,  12  and  14 , are substantially clear and a person can visual see directly through the dual layers,  12  and  14 , to objects located on the other side of the dual layers,  12  and  14 . Preferably, each of the dual layers,  12  and  14 , are continuously transparent or translucent throughout their entire body so as not to block, absorb, reflect, or prevent substantially any transmission of light through any part of the assembly  10  and therefore, enable maximum passage of light to the patient&#39;s skin  20  lying directly underneath the assembly  10 . The only exception is the relatively small and thin lead wire  18  which may not be transparent and may absorb and/or reflect rays of light. Otherwise, the entire assembly  10  is transparent or translucent to light and permits light rays “R” emitted by a phototherapy device, or light source,  22  to shine through the layers,  12  and  14 , onto the skin  20  of the patient. See  FIGS. 4 and 5 . 
         [0018]    Preferably, the dual layers,  12  and  14 , include a lower flexible layer  12  intended to engage the skin  20  of the patient and an upper flexible layer  14  that faces outward of the skin  20  toward the phototherapy, or light source, device  22 . The flexibility of the layers  12  and  14  enable the assembly  10  to conform to the contour of the skin  20  on which it is attached. Flexibility is particularly important for relatively large assemblies having a relatively large surface area. Alternatively, the layers,  12  and  14 , can be substantially rigid if the assembly is relatively small and has only a small surface area. 
         [0019]    As an example, the lower layer  12  can be a sticky, tacky, or self-adhesive gel-like substance. Such a gel layer  12  can be electrically-conductive such that it electrically couples the lead wire  18  to the skin  20 . In addition, the gel layer  12  can have an exterior relative-tacky surface enabling the gel layer  12  to be removably self-adhered directly to the skin  22  of the patient. The upper face  24  of the gel layer  12  can also be tacky for purposes of self-adhering the lead wire  18  thereto and for adhering the upper layer  14  thereto. Alternatively, separate adhesive layers can be used. 
         [0020]    The upper flexible layer  14  can be made of the same gel material as the lower flexible layer  12 . If desired, the upper gel layer  14  can made of a conductive gel material, or more preferably, a non-conductive gel material. Its surfaces can be tacky to enable it to form a strong bond with the lower gel layer  12  and lead wire  18 . Its upper face  26  can also be tacky to enable the separate phototherapy, or light source, device  22  to be removably adhered thereto. See  FIG. 5 . Alternatively, the upper layer  14  may not have a self-adherent property. 
         [0021]    Preferably, the assembly  10  is provided as a disposable medical electrode assembly. For instance, as best illustrated in  FIG. 1 , the assembly  10  can initially be provided on a release sheet  28  that can be peeled away from the underside of the assembly  10 . Also, the lead wire  18  can have a proximal free end forming a connection tip  30 . In this manner, a lead wire of an electrical stimulation device  32  can be connected to tip  30 . However, when discarding a used assembly  10 , the assembly can be disconnected and only the short portion  34  of the lead wire need be discarded. 
         [0022]    A method of treatment according to the present invention includes adhering lower layer  12  to the skin  20  of the patient. The proximal end of the lead wire  18  can be electrically connected to the electrical stimulation device  32  for electrically stimulating the patient via the medical electrode assembly  10 . As an example, electrotherapy is typically given for about a period of 8 to 12 minutes depending upon the purpose of the application. 
         [0023]    Simultaneously with the electrotherapy treatment, a phototherapy light source  22  can be used to provide phototherapy to the skin  22  of the patient, including the skin located directly underneath the medical electrode assembly. Phototherapy treatment typically is longer in duration then electrotherapy treatment. Thus, there may be periods of time where only phototherapy treatment or only electrotherapy treatment is applied. However, the use of the medical electrode assembly  10  enables the treatments to be applied simultaneously or sequentially without any disconnection or re-connection of the electrode assembly to the patient. 
         [0024]    According to one contemplated embodiment, the phototherapy light source  22  comprises a small lightweight light emitting diode (LED) cluster that can be adhered directly to the upper tacky face  26  of the upper layer  14  of the assembly  10 . Thus a phototherapy treatment and an electrotherapy treatment can be given simultaneously to substantially the same region of the body. Alternatively, the light source can be a large bank of lights not supported on the assembly or connected to the assembly. 
         [0025]    The type of light rays used during phototherapy depends upon the purpose of the application. Visible or optical light having a wavelength of about 400 nm to 700 nm could be used, and the assembly  10  could permit such electromagnetic radiation to pass through the layers,  12  and  14 , of the assembly. Alternatively, ultraviolet rays could be used, including UV-A, UV-B, or UV-C rays. This would correspond to electromagnetic radiation of a wavelength within the range of about 10 to 400 nm. Still further, infrared rays could be used, including near or far infrared. This would correspond to electromagnetic radiation of a wavelength within the range of about 700 nm to 1,000,000 nm. According to one contemplated embodiment the medical electrode assembly would permit passage of light rays having a wavelength of between 280 nm to 50,000 nm, or alternatively, between 400 nm and 1000 nm. 
         [0026]    While preferred electrodes and methods of treatment have been described in detail, various modifications, alterations, and changes may be made without departing from the spirit and scope of the electrode assembly and method according to the present invention as defined in the appended claims.