Abstract:
A low-profile self-charging and contouring bladder system assists circulation in a treatment region. Bladders capable of self-inflation and deflation incorporate entry and exit check valves having predetermined cracking pressures to maintain internal pressure above the ambient pressure of the ambient environment. Recharging check valves having low cracking pressures at or slightly above atmospheric pressure, combined with the self-inflation properties of the bladders promotes bladder pressurization. Bladders are disposed in sleeves designed to fit various parts of a wearer&#39;s body, and connected in series to allow the apparatus to work across a large region. The system is designed at pressures so that normal bodily movement, including skeletal bending and twisting, causes bladders to expel fluid and take in fluid in a manner causing pressure waves to move across the treatment region.

Description:
[0001]    This application is a continuation in part of application Ser. No. 11/701,625 entitled “Self Actuating Sequential &amp; Gradient Compression Apparatus,” filed Feb. 2, 2007, now abandoned. 
       BACKGROUND 
       [0002]    Many venous ailments such as result from diabetes or lymph and other types of edema often result in poor circulation which adversely affect quality of life, can result in gangrene, resulting in amputation, and may eventually may become life threatening over time. One method of treatment is to apply elastic compression garments or compression bandaging to force fluids through the body under static pressure. A more advanced technique involves sequential gradient pump therapy wherein overlapping cells promote movement of fluids. Current sequential pump devices in the art typically include powered systems which are elaborate. Users of such systems are unable to engage in normal activities during operation of the device. Importantly, this prevents such devices from being used as a preventative treatment. 
         [0003]    There is therefore needed a self-charging apparatus capable of carrying out sequential pump therapy that allows patients to engage in normal activities while the apparatus is in use. There is also a need for an apparatus that avoids problems associated with bladder leakage and recharging, and which can be adapted to large areas of the body and its extremities. It is therefore among the objects of the present apparatus to provide a self-contained, self-recharging, and modular inflatable bladder system to provide sequential pump therapy to areas of a user&#39;s body, while allowing the user to pursue normal activities and movement. In addition to circulatory improvement, it is anticipated that the apparatus will improve climate control when combined with articles of clothing, and will result in improved comfort and safety in prosthetic sockets. 
       SUMMARY 
       [0004]    An apparatus is disclosed for applying waves of fluid pressure to an area of a user&#39;s body using the user&#39;s own bodily movements to generate the pressure, including vector forces generated from bending movement. The apparatus includes a resilient bladder of a predetermined volume. The bladder has an entry check valve for fluid ingress, an exit check valve for fluid egress, and a recharging check valve for ingress of ambient fluid surrounding the bladder. In an exemplary embodiment, the fluid is air. A means for bearing the bladder against the user&#39;s body causes the bladder to apply pressure against the area. 
         [0005]    The bladder is adapted to deform responsive to a user&#39;s bodily movements, reducing the volume of the bladder, and elastically reform. To assist in the reforming process, a compressible extruded elastic member is incorporated into the bladder, helping to re-inflate the bladder after deformation. In one embodiment, the bladder is generally tube shaped and adapted to deform between 0.25 and 1 inch when compressed, thereby allowing the bladder to maintain a low profile as it fills with fluid. In bladders of this configuration, the extruded elastic member may include a series of fins radiating from a central axis. 
         [0006]    The bladder tubing is configured so that fluid movement generates a pressure wave moving from the treatment area toward a user&#39;s torso to assist normal circulation. Such a configuration may include several interconnected bladder tubes or a single tube arranged in a predetermined pattern such as a “S” shape. 
         [0007]    To apply pressure toward the area of the user&#39;s body, the bladder may be constructed to have a more elastic first surface adjacent the area, and a substantially inelastic second surface. In this manner, the side of the bladder facing the area to be treated deforms and reforms to a greater extent than the side of the bladder facing away from the user. The fins of the elastic extruded member should conform to the shape of the bladder when inflated to maximize reforming speed. 
         [0008]    The bladder has an entry check valve, an exit check valve and a recharging check valve in communication with the bladder&#39;s ambient environment. The exit check valve has a cracking pressure between 0 and 0.58 psi, and the recharging check valve has a cracking pressure above 0 psi. It is also anticipated that the bladder may include internal check valves to govern fluid movement within a single compartmentalized bladder. 
         [0009]    Due to the recharging check valve&#39;s low cracking pressure, any vacuum pressure in the reforming bladder greater than ambient environmental fluid pressure urges ambient fluid into the bladder. In this manner, fluid entering and exiting the bladder through the check valves generates pressure waves across the area as a user engages in normal bodily movement. It is also desirable, although not necessary to have recharging check valves located inside the bladder along its tubular length to urge fluid and a corresponding pressure wave across the bladder in one direction. 
         [0010]    As the bladder is charged by virtue of a user&#39;s bodily movements, pressure builds in the bladder until the cracking pressure of its exit valve is reached, at which point the bladder expels the fluid, reducing pressure against the exit valve. This process repeats, causing a constant stream of downstream pressure waves moving in a single direction. One advantage of this arrangement is that multiple bladders may be in fluid communication and connected in series by having the exit check valve of a first bladder serve as the entry check valve of a second bladder downstream from the first. 
         [0011]    Bodily circulation is best encouraged when the greatest pressure is exerted at the ends of the extremities, and successively lower pressures exerted toward a user&#39;s torso. In order to accomplish this goal, and to ensure bladders connected in series urge circulation in the proper direction, the bladders are preferably adapted to develop successively lower pressure waves from one bladder to the next as the bladders approach a user&#39;s torso. 
         [0012]    The apparatus is designed to have a maximum operational pressure of 0.58 psi, as pressures above this level may be harmful. In order to prevent the bladder, or series of bladders, from over pressurizing, an exhaust or safety check valve may be incorporated having a cracking pressure of between 0.58 and 1.0 psi. Further, in another exemplary embodiment, the final exit check valve in a series of bladders may be connected to a channel leading to the entry check valve of the first bladder in the series. In this manner, air exiting the last bladder will be immediately transferred to the first bladder, ensuring the continuity of pressure waves along the device. 
         [0013]    It is anticipated that a variety of check valves having the prescribed cracking pressures may be used in the apparatus. One exemplary embodiment that is contemplated includes a check valve having a tube with a seat and opening. The check in such a valve includes a spheroid shape adapted to block the valve&#39;s seat. Also included in the tube is a series of opposing and parallel helical steps, the steps being adjacent the opening and downstream from the check. The check also includes a retaining rod attached to the spheroid by a filament, adapted to engage the helical steps. By disposing the retaining rod on a pair of steps farther up or down the tube, the strength of the check valve can be set to an optimal pressure. 
         [0014]    More fluid pressure is required to dislodge the spheroid from the seat when the retaining rod is set closer to the seat, and less pressure is required when the retaining rod engages steps closer to the tube opening due to the rigidity of the material comprising the valve. It is anticipated that the tube may be made of a rigid thermoplastic material, or thermoset material, while the spheroid is elastomeric. In an exemplary embodiment, medical grade polymers are used to construct the check valves. 
         [0015]    Having provided the bladder system for urging waves of fluid pressure along the treatment area using entry, exit and recharging check valves, it may be necessary to provide a support structure adapted to preserve the bladder adjacent to and bearing against the treatment area. A sleeve is contemplated into which a bladder may be incorporated. In an exemplary embodiment, the sleeve is substantially tube shaped, surrounding a portion of the user&#39;s body and applying the bladder thereto. The bladder may extend partially or wholly around the inside of the sleeve. It is anticipated that bladders connected in series may be incorporated into either a series of sleeves, or into a single sleeve capable of holding several bladders. 
         [0016]    To assist the bladder in providing the waves of fluid pressure, the sleeve ideally is constructed of a material making it circumferentially inelastic and longitudinally elastic. The selective elasticity of the sleeve is adapted to modify the pressure waves generated by the apparatus, intensifying them in appropriate areas. In addition to the sleeve material applying the bladder to the treatment area, the sleeve also comprises a material between the bladder and the treatment area permitting the assembly to be easily attached and removed, and when worn, to prevent the bladder or bladders from binding the user&#39;s skin. 
         [0017]    In order to use the apparatus, a sleeve containing at least one elastic bladder is placed over the treatment area. In an exemplary embodiment, an extremity such as an arm may be slid into the sleeve in a manner similar to a conventional article of clothing. As the sleeve reaches the treatment area, and the user begins to engage the area in skeletal movements, pressure on a bladder between the sleeve and the user&#39;s body causes the bladder to deform and reform, thereby causing fluid to move through the bladder. As bladder pressure meets the cracking pressure of an exit check valve, fluid moves downstream into another bladder, equalizing bladder pressure, completing the cycle. 
         [0018]    Cycles of bladder pressurization and depressurization cause pressure waves to move over the treatment area in a pattern designed to urge circulation of the user&#39;s internal fluids. By connecting bladders in series with bladders of the greatest cracking pressure first, and bladders of gradually lower cracking pressure downstream from the first bladder, a user&#39;s internal fluids are directed toward the user&#39;s torso. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0019]      FIG. 1  shows a single bladder having entry, exit and recharging check valves. 
           [0020]      FIG. 2  shows a single bladder having interconnected tubes. 
           [0021]      FIG. 3  shows a single bladder having a single tube configured in an “S” shape. 
           [0022]      FIG. 4  shows an elastic extruded member having fins to re-inflate a bladder. 
           [0023]      FIG. 5  shows an array of bladders in fluid connection and arranged in series. 
           [0024]      FIG. 6  shows a bladder array in a closed-loop system. 
           [0025]      FIG. 7  shows a cross section of a check valve. 
           [0026]      FIG. 8  shows a cross section of a check valve rotated 90 degrees. 
           [0027]      FIG. 9  shows a bladder incorporated into a sleeve. 
           [0028]      FIG. 10  shows a series of sleeves adapted to connect together. 
           [0029]      FIG. 11  shows an apparatus having multiple sleeves adapted to treat a user&#39;s arm. 
       
    
    
     DESCRIPTION 
       [0030]    Referring to  FIG. 1 , a resilient bladder  100  of a predetermined volume has an entry check valve  110  for fluid ingress, an exit check valve  120  for fluid egress, and a recharging check valve  130  for ingress of ambient fluid surrounding the bladder  100 . In an exemplary embodiment, the fluid is air. In another exemplary embodiment, the bladder  100  is generally tube-shaped and adapted to deform between 0.25 and 1 inch when compressed, thereby allowing the bladder  100  to maintain a low profile as it refills. 
         [0031]    Still referring to  FIG. 1 , to apply pressure toward the area of the user&#39;s body, the bladder  100  may be constructed to have a more elastic first surface  140  adjacent the area, and a substantially inelastic second surface  150 . In this manner, the first surface  140  side of the bladder  100  facing the area to be treated deforms and reforms to a greater extent than the second surface  150  side of the bladder  100  facing away from the user. 
         [0032]    Referring to  FIGS. 2 and 3 , the bladder  100  tubing is configured so that fluid movement generates pressure waves to assist normal circulation. Such a configuration may include several interconnected bladder  100  tubes as shown in  FIG. 2 , or a single bladder  100  tube arranged in a predetermined pattern such as an “S” shape as shown in  FIG. 3 . It is also anticipated that bladders may be tacked to an inelastic surface, allowing them to completely inflate relative to the inelastic surface. In this arrangement, the bladders are positioned so that when deflated, there is no overlap between the bladders to preserve the low profile of the apparatus. 
         [0033]    Referring to  FIG. 4 , an extruded member  160  assists in reforming the bladder  100  once compressed. The extruded member  160  is compressible and elastic, helping to re-inflate the bladder  100  after deformation. In bladders  100  having a tube shape, the extruded elastic member  160  may include a series of fins  170  radiating from a central axis  180 . In cases where the bladder  100  has a first side  140  that deforms to a greater extent than the second side  150 , the fins  170  of the elastic extruded member  160  should conform to the shape of the bladder  100  when inflated by selectively altering the length of the fins  170 . The strength of the extruded member  160  may be determined by the thickness of the fins  170 . It is anticipated that a variety of resilient porous elastic materials may be used in place of the extruded member  160 . 
         [0034]    Still referring to  FIG. 1 , the bladder  100  has an entry check valve  110 , an exit check valve  120  and a recharging check valve  130  in communication with the bladder&#39;s  100  ambient environment. The exit check valve  120  has a cracking pressure between 0 and 0.58 psi, and the recharging check valve  130  has a cracking pressure above 0 psi. As shown in  FIG. 3 , it is also anticipated that the bladder  100  may include internal check valves  190  to govern fluid movement within a single compartmentalized bladder  100 . 
         [0035]    Due to the recharging check valve&#39;s  130  low pressure, any vacuum pressure in the reforming bladder  100  greater than ambient environmental fluid pressure urges ambient fluid into the bladder  100  assisting re-inflation. In this manner, fluid entering and exiting the bladder  100  through the entry  110  and exit  120  check valves generates pressure waves across the area as a user engages in normal bodily movement. As mentioned above, it is also possible to have recharging check valves  190  located inside the bladder  100  along its tubular length to urge fluid and the corresponding pressure wave across the bladder  100  in one direction. 
         [0036]    As the bladder  100  is charged by virtue of a user&#39;s bodily movements, bending and flexing, pressure builds in the bladder  100  until the cracking pressure of its exit valve  120  is reached, at which point, the bladder  100  expels the fluid, reducing pressure in the exit  120  valve. This process repeats, causing waves of repeated downstream pressure moving in a single direction through the bladder  100 . One advantage to this arrangement is that multiple bladders  100  may be in fluid communication and connected in series by having the exit check valve  120  of a first bladder serve as the entry check valve  110  of a second bladder  100  downstream from the first bladder  100 . 
         [0037]    Referring to  FIG. 5 , a series of bladders  100  are connected in series to form a bladder array  200  adapted to cover a larger treatment area. As shown in the drawing, adjacent bladders  100  share entry  110  and exit  120  check valves. Each bladder  100  also incorporates a recharging check valve  130 , to allow any of the bladders  100  to recharge individually. 
         [0038]    Bodily circulation is best encouraged when the greatest pressure is exerted at the ends of the extremities, and successively lower pressures exerted toward a user&#39;s torso. In order to accomplish this goal, and to ensure bladders  100  connected in series  200  urge circulation in the proper direction, the bladders  100  are preferably adapted to develop successively lower pressure waves from one bladder  100  to the next as the bladders  100  approach a user&#39;s torso. 
         [0039]    The apparatus is designed to have a maximum operational pressure of 0.58 psi, as pressures above this level may be harmful. In order to prevent a bladder  100  or series  200  of bladders, from over pressurizing, an exhaust or safety check valve  210  may be incorporated into the series  200  having a cracking pressure of between 0.58 and 1.0 psi. In any event, pressure in the apparatus should never exceed 5.0 psi. Referring to  FIG. 6 , in one exemplary embodiment, the final exit check valve  120  in a series of bladders  100  may be connected to a channel  220  leading to the entry check valve  110  of the first bladder  100  in the series. In this manner, air exiting the last bladder  100  will be immediately transferred to the first bladder  100 , ensuring the continuity of pressure waves along the device. 
         [0040]    It is anticipated that a variety of check valves having the prescribed cracking pressures may be used in the apparatus. Referring to  FIGS. 7 and 8 , one exemplary embodiment includes a check valve  300  having a tube  305  with a seat  310  and opening  315 . The check  325  in such a valve  300  includes a spheroid  330  adapted to engage the seat  310 . Also included in the tube  305  is a series of opposing and parallel helical steps  320 , the steps  320  being adjacent the opening  315  and upstream from the check  325 . The check  325  also includes a retaining rod  350  attached to the spheroid  330  by a tensile filament  360 , adapted to engage the helical steps  320 . By engaging the retaining rod  350  against a given pair of helical steps  320 , the strength of the check valve  300  can be set to an ideal pressure, as the tensile filament  360  will exert more or less pressure on the spheroid  330 , anchoring it closed in the check  325 . 
         [0041]    Less fluid pressure is required to dislodge the spheroid  330  from the seat  310  when the retaining rod  350  is set closer to the seat  310 , and more pressure is required when the retaining rod  350  engages the helical steps  320  closer to the tube  305  opening due to the greater tensile load on the filament  360 , and pressure of the spheroid  330  against the material comprising the valve  300 . It is anticipated that the tube  305  may be made of a rigid thermoplastic material, or thermoset material, while the spheroid  330  is elastomeric. In an exemplary embodiment, medical grade polymers are used to construct the check valves  300 . 
         [0042]    Having provided the bladder  100  or series  200  of bladders  100  for urging waves of fluid pressure along the treatment area using entry  110 , exit  120  and recharging  130  check valves, it may be necessary to provide a support structure adapted to preserve the bladder  100  adjacent to and bearing against the treatment area. Referring to  FIG. 9 , a sleeve  400  is shown into which a bladder may be incorporated. In an exemplary embodiment, the sleeve  400  is substantially tube shaped, adapted to surround a portion of the user&#39;s body and apply the bladder  100  thereto. The bladder  100  may extend partially or wholly around the inside of the sleeve  400 . It is anticipated that bladders  100  connected in series  200  may be incorporated into either a series of sleeves  400  as shown in  FIG. 10 , or into a single sleeve  400  capable of holding several bladders  100 . 
         [0043]    To assist the bladder in providing the waves of fluid pressure, the sleeve  400  is ideally constructed of a first material  410  making it substantially circumferentially inelastic and longitudinally elastic. The selective elasticity of the sleeve  400  is adapted to modify the pressure waves generated by the apparatus, intensifying them in appropriate areas. In addition to the first sleeve material  410  forcing the bladder against the treatment area, the sleeve  400  also comprises a second material  420  between the bladder and the treatment area permitting the assembly to be smoothly put on and taken off, and when worn, to prevent the bladder  100  or bladder series  200  from binding the user&#39;s skin. 
         [0044]    As shown in  FIG. 11 , a series of sleeves  400  may be arranged in series and fluidly connected. In order to use the apparatus, a sleeve  400  containing at least one elastic bladder  100  is placed over the treatment area. In an exemplary embodiment, an extremity such as an arm may be slid into the sleeve in a manner similar to a conventional article of clothing. It is also contemplated that the sleeve may be incorporated into a conventional article of clothing. As the sleeve  400  reaches the treatment area, and the user begins to engage the area in skeletal movements, pressure on a bladder  100  between the sleeve  400  and the user&#39;s body causes the bladder  100  to deform and reform, causing fluid to move through the bladder  100 . As bladder pressure meets the cracking pressure of an exit check valve  120 , fluid moves downstream into another bladder, equalizing bladder  100  pressure, completing the cycle. 
         [0045]    Cycles of bladder  100  pressurization and depressurization case pressure waves to move over the treatment area in a pattern designed to increase circulation of the user&#39;s internal fluids. By connecting bladders  100  in series  200  with bladders  100  of the greatest cracking pressure first, and bladders  100  of gradually lower cracking pressure downstream from the first bladder  100 , a user&#39;s internal fluids are directed toward the user&#39;s torso. 
         [0046]    While the present invention has been described with regards to a particular embodiment, it is recognized that additional variations of the present invention may be devised by persons skilled in the art without departing from the inventive concepts disclosed herein.