Abstract:
A fluid filled applicator conformed to position a source of electromagnetic radiation adjacent a portion of human anatomy to interpose a fluid of known characteristics between the source and the adjacent tissue includes in its first form a generally resilient envelope rendered conformable to the body surface to which it is applied by adjusting the internal pressure therein. In an alternative form the fluid is confined to a selected depth of a vertical container and the limb or body part is then immersed therein while contained in a flexible sheath. The source may then be applied to any selected exterior portion of the container.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The present invention relates to resiliently conformable devices and more particularly to resilient charge applicators pressurized for conforming fit with selected surfaces and portions of the human anatomy. 
         [0003]    2. Description of the Prior Art 
         [0004]    Devices that in one manner or another selectively direct an electromagnetic field or charge to parts of human anatomy have been known in the past, including devices that apply pulsed signals useful in stimulating bone tissue repair like those described in U.S. Pat. Nos. 5,217,009 to Kronberg; and 4,430,999 to Brighton, et al.; devices for stimulating muscle by electrical charge or current like that exemplified in U.S. Pat. No. 4,249,537 to Lee et al.; and devices that apply beneficial light like that described in U.S. Pat. Nos. 5,913,883 to Alexander et al., 6,069,066 to Chen et al., 6,471,716 to Pecukonis; or those described in U.S. Pat. Nos. 6,378,760 and 7,130, 689 issued earlier to this inventor. In each instance these fields, currents or other electromagnetic charges are delivered to the treated body site by a hand-held or mechanically mounted device brought generally proximate the patient&#39;s limb or area of interest. As result of this general placement imprecise and uneven distance distributions are inherent between the face of the emitting source and the receiving body surface portions which, because of the exponential field strength effect with distance, often affect the efficacy of treating process. 
         [0005]    To overcome these geometric imprecisions some devices in the above described prior art like the &#39;883 and &#39;066 patents, or devices like those described in U.S. Pat. No. 6,443,978 issued to Zharov, distribute an array of emitting sources over convolved surfaces that generally conform, or are conformable, to the anatomy that is to be treated. While suitable for the purposes intended, these prior art structures either entail plastically conformable surfaces, or an array of surface shapes adapted for various surface matching, that are either numerically burdensome or require manipulative strength and dexterity to effect the desired matching panel conformation. 
         [0006]    Moreover, many charge devices, including those described in my previous &#39;760 and &#39;689 patents, interpose a controlled volume of liquid or gas between the charge source and the body surface, a configuration that may be masked or affected by the air gaps therebetween that variably attenuate any electromagnetic transmission into the treated tissue. This variability adversely affect the treating efficacy of the device while also encumbering the treating staff with the repeating need for device re-positioning as the patient&#39;s posture changes in the course of any treatment regimen. A mechanism that conveniently fixes the charge source and its associated intervening liquid or gas volumes relative the treated body portion is therefore extensively desired and it is one such mechanism that is described herein. 
       SUMMARY OF THE INVENTION 
       [0007]    Accordingly, it is the general purpose and object of the present invention to provide a resiliently deformable applicator enclosure conformed for selected internal pressurization. 
         [0008]    Other objects of the invention are to provide a resilient envelope dimensioned to surround a selected portion of the anatomy of a person. 
         [0009]    Further objects of the invention are to provide a closed liquid volume between the applicator electrodes of a electrical stimulation device and the treated portion of a person. 
         [0010]    Yet additional objects of the invention are to provide a compliant fluid containment envelope provided with an electrode on one surface thereof and internally pressurized for conformable contact with selected portions of a human anatomy. 
         [0011]    Briefly, these and other objects are accomplished within the first embodiment of the present invention by providing a first resilient pouch or envelope defined by a first and a second membrane each of a generally rectangular planform joined at their respective peripheries to the other to form an enclosure or envelope confining a volume fluid therebetween. Preferably the fluid pressure within the enclosure is maintained at a level at which compliant contact can be effected between one of the membranes thereof and a selected portion of human anatomy so that any field or radiation pattern from an electrode on the exterior of the other opposed membrane encounters few or no air gaps in its propagation path to the body surface. In this manner the interposing matter between the electrode and the tissue that is treated comprises primarily the two membranes themselves and the fluid confined therebetween, thus assuring the conductivity and any electropotential effects in the transmission to the treated site. To assure this envelope compliance a fluid transfer path may be provided across a pressure relieving valve into the interior of a collapsed second storage envelope, the relief valve further including a manually operable mechanism to allow the fluid stored therein to drain back, by gravity, into the first envelope. By selecting the vertical drop between the first and second envelopes in the course of this draining process the internal pressure bias and the resulting compliance of the first envelope are conveniently adjusted. 
         [0012]    In a second embodiment the internal pressure of the fluid within the enclosure may be controlled by a manually adjustable accumulator structure in which the accumulator pressure is adjusted by pneumatically increasing the pressure on the exterior of the accumulator surface. In this manner the internal pressure of the fluid in the envelope may be controlled to meet the compliance needs of the body surface that is treated. 
         [0013]    A third embodiment of the invention utilizes an open container having the electrode or emitting source adhered to the exterior of one wall thereof with the limb that is to be treated then inserted into a closely compliant sheath and thus covered then immersed in the fluid in the container. The pressure head obtained by the depth of the limb immersion then assures close contact between the sheath and the limb thereby limiting any air gaps between the source and the area treated. 
         [0014]    Those skilled in the art will appreciate that each of the foregoing embodiments limits the incidence of unwanted gaps along the transmission path of a charge or current through human tissue. In this manner only the normal variations in the insulative or dielectric properties of human skin provide the operational variables and these can be controlled by hydrating ointments or other creams that either promote or reduce conductivity. In consequence the charge potential and also the current levels and densities can be accurately determined, an advantage particularly useful in the functional modalities taught in this inventor&#39;s prior U.S. Pat. Nos. 6,378,760 and 7,130,689. Thus while broadly useful the above summarized inventive embodiments are particularly advantageous in the processes described in the &#39;760 and &#39;689 patents and similarly operating processes. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]      FIG. 1  is a perspective illustration of the first embodiment of the inventive applicator structure in place on a limb of a person; 
           [0016]      FIG. 2  is a diagrammatic illustration of the structure useful with the first embodiment of the inventive applicator structure; 
           [0017]      FIG. 3  is a sectional detail of the inventive relief valve shown in  FIGS. 1 and 2 ; 
           [0018]      FIG. 4  is a further diagrammatic illustration of the first embodiment of the inventive applicator structure having portions thereof positioned at various selected relative elevations for controlling the internal fluid pressure therein; 
           [0019]      FIG. 5  is yet another perspective illustration including portions in partial section, illustrating a second embodiment of the inventive applicator structure; 
           [0020]      FIG. 6  is a sectional side view taken along line  6 - 6  of  FIG. 5 , illustrating an inventive accumulator useful herein; 
           [0021]      FIG. 7  is a further perspective illustration, including portions in partial section, illustrating a third embodiment of the inventive applicator structure; and 
           [0022]      FIG. 8  is a further sectional side view detail taken along line  8 - 8  of  FIG. 7 . 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0023]    As shown in  FIGS. 1-4  the inventive applicator structure, in accordance with its first embodiment generally designated by the numeral  10 , comprises an applicator envelope  11  defined by a resilient upper membrane  12  and a substantially equally dimensioned lower resilient membrane  13  joined to each other at their respective peripheries  12   p  and  13   p  to form a fluid impervious enclosure. Preferably membranes  12  and  13  are each of a rectangular planform having the longer dimension thereof equal or greater than the larger peripheral arcs of the major areas of human anatomy such that the weight of any fluid in the envelope will result in a conforming contact between the lower membrane  13  and the adjacent body surface BS. By eliminating most air gaps this conforming contact then assures a repeatable transmission path between a planar electrode  15  adhered to the exterior of the lower membrane  13  and the subjacent body surface, a path that includes the upper membrane, the height of the fluid FL confined in the envelope  11  and the lower membrane  13 , but very little else. 
         [0024]    To further assure conforming compliance of envelope  11  with the body surface BS on which it rests the first embodiment  10  is provided with a gravity assisted pressurization arrangement including a closed, resilient overflow pouch  21  in which an excess of the fluid FL is stored. A flexible fluid transfer hose  22  provided with a manually releasable check valve mechanism  25  connects pouch  21  to envelope  11  to allow the deployment of the pouch at various elevations relative the envelope and thereby modify the internal fluid pressure in the envelope. This transfer may be effected by providing an enlarged handle  27  on a valve pindle  26  opposed by the relief spring  29 . Handle  27  can then be manipulated through the resilient walls of the hose  22  to lift the pindle  26  from its seat  28  while the pouch  21  is raised or lowered to heights I, II or III to raise or lower the internal fluid pressure within envelope  11 . Once the desired pressure level is obtained the valve handle  27  is released, re-seating pindle  26  on its seat  28  which then fixes the interior pressure in envelope  11 . 
         [0025]    Those in the art will appreciate that the foregoing arrangement fully and completely confines the whole of the fluid FL within the common interiors of envelope  11 , hose  22  and the pouch  21 . In this manner the chemical constituents of the fluid FL remain uncontaminated, allowing for the accurate transmission therethrough of the charges, fields or currents issued from circuit  30  like that earlier described by this inventor in the U.S. Pat. Nos. 6,378,760 and 7,130,689. Moreover, for those instances where the gaseous nature of the fluid FL precludes effective pressure, and therefore compliance, control by gravity gradient the instant teachings include a second embodiment, shown in  FIGS. 5 and 6  and generally designated by the numeral  110 , in which a resilient envelope  111  is connected by a hose  122  to an accumulator  121 . Accumulator  121 , in turn, includes a pressure biasing chamber  126  separated by a flexible wall  127  from the common interior  123  communicating into envelope  111 , the biasing chamber  126  further including a manually operable pump  128  by which its internal pressure can be raised. This added pressure in the biasing chamber  126 , together with the elastic tension in wall  127 , then determine the pressure in the envelope. 
         [0026]    Like numbered parts functioning in a like manner to that previously described, the foregoing arrangement insures a compliant contact between the lower membrane  13  of envelope  111  and the adjacent body surface. Moreover, the fluid constituents confined within envelope  111  between membranes  12  and  13 , and therefore the medium through which any emission-absorption cascades may occur, remain uncontaminated thereby insuring the efficacy of the process. As before, this cascade or other charge originates at electrode  15  radiating along a path that includes the fluid FL with its desired constituents and then into the tissue. 
         [0027]    It will be appreciated that both the foregoing embodiments conveniently conform to various body shapes by simply adjusting the internal fluid pressure in either envelope  11  or  111 . Then, once the desired surface contact is achieved either the handle  27  on the relief valve is released, reseating the valve, or the desired biasing pressure is achieved in cavity  126  by manipulating pump  128 . This conforming alignment can then be retained by a set of straps  18  and  19  extending from the peripheral edge  13   p , each provided with selectively engageable hook and pile surfaces  18   v  and  19   v  like those sold under the mark or style VELCRO. In this manner long treatment periods can be comfortably sustained. 
         [0028]    Those skilled in the art will further appreciated that other treatment regimens either using light or laser sources or even a heat source are easily accommodated in these same structures. For example, in those instances where the treatment entails small current or heat flows into the treated tissue delivered from electrode or source  15  then its positioning is best effected on the exterior of the lower membrane  13 . Of course, the designation of ‘lower’ and ‘upper’ when referring to the membranes here is for descriptive purposes only as the envelopes  11  and  111  and their securement may be rendered fully reversible, the intent being that both direct skin contact with the electrode or a mediated path that includes propagation through fluid FL are easily accommodated in the same structure. 
         [0029]    By reference to  FIGS. 7 and 8  a third embodiment of the present invention, generally designated by the numeral  210 , is conformed generally as a container in which an extremity can be immersed. This fluid container appears as a hollow, generally rigid, enclosure  211  defined by a lower chamber  212  communicating into a vertical, somewhat narrower, stack  213 , chamber  212  and stack  213  then in combination defining a volume useful to store fluid FL into which a limb LB of a patient can be extended through an upper opening  214  to be immersed. Of course, the height of the fluid FL and its density will then define the pressure gradient around the immersed limb either to determine the local fluid pressure on the patient&#39;s skin or to provide sufficient external pressure on the surfaces of an impervious flexible bag  216  covering the limb so that all the folds thereof are fully collapsed to drive any trapped air therefrom. Once again, the electrode  15  may be then affixed at any desired exterior surface portion of the lower exterior surfaces  215  of chamber  212 , thereby defining a repeatable transmission configuration between the electrode and the treated part of the person. 
         [0030]    Those skilled in the art will appreciate that each of the foregoing embodiments seeks to minimize the volumes trapped within the spurious foldings of a membrane as it conforms with the various anatomical topographies of the patient by selecting the desired pressure differential thereacross. These benefits are particularly significant in a setting where the patient&#39;s skin, itself, has lost its local integrity by injury, disease or condition and a high skin impedance is necessary to insure effective treatment. Where higher current densities are a preferred part of the regimen direct immersion is then obtained. In this manner a widely useful application arrangement is obtained that is useful with a wide range of regimens. 
         [0031]    Obviously many modifications and variations of the instant invention can be effected without departing from the spirit of the teachings herein. It is therefore intended that the scope of the invention be determined solely by the claims appended hereto.