Abstract:
A portable lavage apparatus for irrigating or washing wounds is disclosed. The apparatus includes a fluid bag, a spring bias mechanism, and a hose. The spring bias mechanism is typically configured to store potential energy or produce kinetic energy used for urging fluid from the fluid bag, through the hose, and toward a wound. The invention has particular advantages in military or civilian environments in that it allows prompt treatment of wounds. Additionally, the lavage apparatus is small enough to be carried by individuals and does not require an external source of power. Accordingly, the portable lavage apparatus may be employed even on battle fields or in remote areas to treat wounds.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the priority benefit of provisional application No. 61/397,628 filed Jun. 14, 2009, entitled “Portable Lavage Apparatus,” the disclosure of which is hereby incorporated by reference. 
     
    
     BACKGROUND 
       [0002]    1. Field of the Invention 
         [0003]    The invention relates generally to portable medical devices, and more particularly to a medical irrigating and/or washing device. 
         [0004]    2. Background Art 
         [0005]    In battle, wounds to the extremities are the most common type of injury. Treatment of such wounds should begin in the field, well before professional expertise is available. Typically for every group of 10-12 soldiers, one specially trained person is available who carries a medical kit. For example, within a few hundred feet behind the front lines, triage units are set up for immediate care of wounded soldiers. In addition to wounds from a variety of weapons, soldiers may also be exposed to chemicals, biological agents, snakes, and other venomous creatures. Regardless of the source of injury, wounded soldiers all need immediate, appropriate care to minimize or prevent death and disabilities. 
         [0006]    Historically, from the era of the Trojan War to the Persian Gulf War, injury patterns have more or less remained the same. An estimate of the mortality rate during the Trojan War era is approximately 77%. Most of these casualties may be attributed to wound shock. During European wars in the 18th and 19th century, wounded soldiers died from collapse of vital functions. Amputation was performed to prevent gangrene and death during the American Civil War (1861-1865). During World War I (1914-1918), excisional debridement replaced amputation for prevention of infection and gangrene. During World War II (1939-1945), common fatalities were classified as hemorrhagic, traumatic, and septic. Mortality decreased from 20% in World War II to 1.8% in the Vietnam War (1955-1975). This may be attributable to improvements in support care through the Korean War (1950-1953), and to the discovery of penicillin in 1928 and its clinical use in 1940. Debridement with drainage and leaving wounds open for healing occur by secondary intention. Recent data from the Persian Gulf War (1990-1991) indicate that wounds to the extremities lead to the highest disability rate. Although the mortality rates have been substantially reduced, still the morbidity and long term disabilities associated with any wound treated by debridement and drainage and leaving the wound open remain the same. 
         [0007]    Regardless of setting (e.g., civilian or military), wounds and infections are treated in a similar manner, with antibiotics, debridement or incision, and drainage. These procedures require expensive dressing changes by trained health care personnel, and may require multiple secondary surgical procedures with potentially poor outcomes (e.g., permanent disabilities). As indicated by war-time experiences dating from ancient times to the present day, an important aspect of care is attending to serious wounds in the battle field. 
         [0008]    When treating infected wounds, open fractures, and wounds contaminated with chemicals and dirt—similar to what soldiers may encounter in a battle field—a better outcome may be attained if the injury is treated with adequate irrigation, debridement, and immediate wound closure. Several hundred cases treated by this unconventional method demonstrate that it can be an effective procedure for caring for injuries (e.g., wounds and open fractures) and may lead to excellent results with full functional recovery (i.e., minimal or no disability). However, current medical devices do not easily attain comparable results for soldiers wounded in the field or even civilians in an optimal environment with a skilled surgeon. 
         [0009]    Wounds are typically cleansed with saline solution, using different types of tubing and syringes. Surgeons may use a pulsed irrigator to irrigate wounds. However, current medical devices may cause harm even in the hands of a well-trained surgeon. Pulsatile flow of solution even under low pressure (e.g., low flow and speed) may cause a significant amount of trauma to tissues and vital structures such as arteries, veins, and nerves. Present medical devices may also cause trauma due to pressure on the tissues, and they may provide inadequate irrigation of the tissues, defeating the intended purpose. If wounds are left open for secondary healing to occur, further expensive care (e.g., systems of dressing changes and treatments such as wound vac (negative pressure wound therapy) frequently administered by nurses) may be required. Complications (e.g., desiccation of tissues, tendons, blood vessels, nerves) causing loss of an extremity or impaired function may also result. Pulsatile flow also depends on a battery and/or air pressured pump. Present medical devices are large (i.e., not portable) and require a fair amount of storage space. 
         [0010]    In addition to irrigation issues and trauma caused by irrigation, the irrigated fluid—contaminated with body fluids, blood, pathogenic organisms—may not be adequately contained or disposed of safely. In the process of administering treatments such as described above, a health care provider may be exposed to dangerous contaminated fluid. 
       SUMMARY OF THE INVENTION 
       [0011]    Various embodiments of the present invention, a portable lavage apparatus, may include a case, a fluid bag, a spring bias mechanism, and a hose. The fluid bag holds a fluid, and the spring bias mechanism may apply pressure to the fluid bag to urge fluid from the bag. The apparatus may further include a tension member configured to extend or compress springs in the spring bias mechanism. 
         [0012]    Other embodiments of the present invention may include a fluid bag, a bias mechanism, and a hose. A base plate may be coupled to an upper plate by a hinge. When the upper plate is pushed toward the base plate by the bias mechanism, the fluid bag is compressed to urge fluid through the hose. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]      FIG. 1  is a diagram showing an embodiment of the portable lavage apparatus in a closed position. 
           [0014]      FIG. 2  shows the lavage apparatus in an open position. 
           [0015]      FIG. 3  shows the lavage apparatus in an open position in readiness for use. 
           [0016]      FIG. 4  shows the lavage apparatus in a closed position. 
           [0017]      FIG. 5  is a perspective view of an embodiment of the portable lavage apparatus. 
           [0018]      FIG. 6  is a perspective view of another embodiment of the portable lavage apparatus. 
           [0019]      FIG. 7  is a perspective view of still another embodiment of the portable lavage apparatus. 
           [0020]      FIG. 8  is a perspective view of a further embodiment of the portable lavage apparatus. 
           [0021]      FIGS. 9A-B  illustrate a still further embodiment of the portable lavage apparatus, depicting it in both relaxed and compressed positions. 
           [0022]      FIG. 10  is a fragmentary side elevation view of the apparatus of  FIG. 9 . 
           [0023]      FIG. 11  is a schematic perspective view of the apparatus of  FIG. 9 . 
           [0024]      FIG. 12  is a perspective view of another embodiment of the portable apparatus of the present invention. 
           [0025]      FIG. 13  is a perspective view of still another embodiment of the lavage apparatus of the present invention. 
           [0026]      FIGS. 14A-C  show the device used as an IV apparatus. 
       
    
    
     DETAILED DESCRIPTION 
       [0027]    A medical device according to various embodiments of the present invention may include (but not be limited to) the following advantageous features: portability, consumes minimal storage space, may operate without an external source of power source (e.g., by using batteries and pneumatic power), substantial portion of device is biodegradable, can be used by lay person without significant medical training (i.e., easy to operate), avoids harm (e.g., trauma from suction and irrigation, traction injury, and pressure injection) caused by current medical devices, variable speed and flow control, may be used on most (if not all) body parts, and works with spray shields and fluid disposal systems (e.g., a universal spray shield with expandable chamber for safe collection and disposal of contaminated fluids). 
         [0028]    For wounds treated according to the present invention, a patient&#39;s (e.g., soldier or civilian) skin may be immediately closed, and healing begun in a triage unit, in the battle field, or in the wilderness or other remote area. Patients may potentially return full time to their original employment with no loss of function or deficits. A patient receives immediate care by irrigating his or her wounds, where adequate irrigation may be used to avoid and prevent infection. After adequate irrigation, hemostasis with appropriate agents or mechanical devices (e.g., clips or sutures) may be applied and the skin may be closed, protecting vital structures. Patients can then be transferred to a specialty medical facility (e.g., hospital or clinic) for further care. 
         [0029]    The portable lavage apparatus  100  according to embodiments of the present invention is illustrated in  FIGS. 1-5 . Referring first to  FIG. 1 , portable lavage apparatus  100  may include a case (or housing)  110 . Case  110  may include two halves  125  and  130  (see  FIGS. 2 and 3 ). Halves  125  and  130  may be coupled to each other by a hinge  155 , and may be secured by a latch  120 . When latch  120  secures halves  125  and  130  together, case  110  is closed as depicted in  FIGS. 1 and 4 . When latch  120  does not couple halves  125  and  130  together and halves  125  and  130  are positioned side-by-side, case  110  is open as shown in  FIGS. 2 and 3 . 
         [0030]    Case  110  surrounds a fluid bag  310  (see  FIG. 3 ) with a coupled dispensing hose  150 . The case  110  may include a spring bias or tension mechanism which urges fluid in fluid bag  310  out through the dispensing hose  150  to outlet nozzle  145 . Outlet nozzle  145  may include a finger- or thumb-operated lever  140  which controls flow of the fluid from fluid bag  310 . For example, the finger- or thumb-operated lever  140  may be coupled to a valve (not shown) in outlet nozzle  145 .  FIG. 2  illustrates hose  150  in a coiled position within half  125  of case  110 .  FIG. 3  illustrates hose  150  extended out of case  110 . 
         [0031]    The spring bias mechanism, as illustrated in  FIGS. 2 and 3 , includes pressure plate  155 . One or more springs  135  may be disposed in case  110 . The springs  135  may be connected at a first end to pressure plate  155  and at a second end to case  110 . As depicted in  FIG. 2 , pressure plate  155  may be in a rest position when springs  135  are at rest, i.e. not extended or compressed. The spring bias mechanism may also include a tension member  165 , which includes tension line  170  and tension ring  175 .  FIG. 2  illustrates tension member  165  in a relaxed state, where most of the tension line  170  is disposed within case  110 .  FIG. 3  shows fluid bag  310  disposed within case  110  after the tension member  165  has been moved to a position as shown in  FIG. 3 . Tension member  165  may additionally or alternatively include a ratchet arrangement (not shown) that enables pressure plate  155  to be withdrawn to and selectively held in the position shown in  FIG. 3 . 
         [0032]    In operation, when the ratchet arrangement is engaged, the ratchet allows pressure plate  155  to move in one direction (e.g., towards a location in half  12  of case  110  where hose  150  extends from case  110 ). When released, the ratchet arrangement does not restrict movement of pressure plate  155 . The spring bias mechanism may store potential energy in the springs  135 —load the springs  135 —when springs  135  are extended (or compressed) by tension member  165 . When springs  135  are extended and tension member  165  is released, pressure plate  15  applies pressure to the fluid bag  310 . When nozzle  145  is moved to its open position by the finger- or thumb-operated lever  140  (for example during cleaning of a wound area), the pressure from pressure plate  155  urges fluid from fluid bag  310  through the nozzle  145 . 
         [0033]    Many materials may be advantageously employed in the apparatus. Case  110  may be formed from any suitable rigid material. Examples of suitable materials include metals (e.g., aluminum, titanium, etc.), polymers (e.g., polyvinyl chloride, polyethylene, etc.), and the like. Case  110  may fit, for example, in a soldier&#39;s or hiker&#39;s first aid kit. In some embodiments, case  110  is smaller than 7 inches long by 6 inches wide by 6 inches tall. Springs  135  maybe formed from, for example, hardened steel, non-ferrous metals (e.g., phosphor bronze, titanium, etc.), beryllium copper, and the like. Pressure plate  155  may, for example, be made from metals, polymers, and the like. In some embodiments, pressure plate  155  is made from thermoplastic acrylic-polyvinyl chloride alloy. Hose  150  may, for example, be made from silicone rubber, latex, and the like. Fluid bag  310  may be made from polyvinyl chloride, ethylene vinyl acetate, copolyester ether, and the like. The fluid used in the fluid bag  310  may be, for example, saline (e.g., normal saline solution 0.90% w/v NaCl), iodine (e.g., 1% povidone-iodine solution), or other antiseptic solutions such as Pluronic F-68, and the like. The fluid in fluid bag  310  may be sterilized (e.g., by autoclaving). 
         [0034]      FIG. 5  is a perspective view of portable lavage apparatus  100 . Portable lavage apparatus  100  may include case  110  (comprising case halves  125  and  130 ), pressure plate  155 , tension line  170 , tension ring  175 , springs  135 , outlet hose  150 , and nozzle  145 . Hose  150  may be connected to coupler or outlet  510 , which may in turn be coupled to fluid bag  310 .  FIG. 5  illustrates the spring bias mechanism in its extended position with tension ring  175  moved away from case  110 . Portable lavage apparatus  100  may be provided with a detent arrangement that enables pressure plate  155  to be held in an open position depicted in  FIG. 5 . The detent arrangement may also be selectively releasable, and pressure plate  155  may be urged against bag  310  to discharge fluid in fluid bag  310  through coupler or outlet  510 , hose  150 , and nozzle  145 . 
         [0035]    The apparatus as depicted in  FIG. 6  may include a support plate  625  with the fluid bag  310  disposed thereon. Outlet  510  is coupled to the fluid bag  310  and to hose (or tube)  150 . A nozzle may be disposed at the distal end of the hose  150 .  FIG. 6  illustrates a cylindrical wound (or coiled) spring  610  (e.g., torsion spring) which may be supported at approximately its center by support mechanism  635  which extends from support plate  625 . An end of wound spring  610  is securely coupled at points  620  to support plate  625 . Support plate  625  may also be coupled to lock  615 . Lock  615  may be attached to an end of fluid bag  310  and hold fluid bag  310  in a (fixed) position when cylindrical coiled spring  610  is unwound. Cylindrical coiled spring  610  may be unwound by manually activating latch release  630 . Latch release  630  may enable cylindrical coiled spring  610  to unwind, urging an outer surface of cylindrical coiled spring  610  against fluid bag  310 , as illustrated in  FIG. 6 . As cylindrical coiled spring  610  urges fluid, from pressure resulting from the contact of cylindrical wound spring  610  against a surface of fluid bag  310 , the fluid in fluid bag  310  may be discharged through outlet  510 . 
         [0036]    The apparatus as shown in  FIG. 7  may include base plate  715 , upper plate  710 , and pressure member  725 . Upper plate  710  is coupled to base plate  715  by hinge  740 . One or more springs  720  each have an end coupled to base plate  715  and another end coupled to pressure member  725 . Springs  720  apply force to pressure member  725 . Fluid bag  310  is shown in a partially compressed position with upper plate  710  being urged downward by pressure member  725 . Latch release button  730  may enable pressure member  725  to rotate and change position along a top surface of upper plate  710 . Pressure member  725  may urge upper plate  710  toward base plate  715 . When compressed between base plate  715  and upper plate  710 , fluid bag  310  releases fluid. Pressure member  725  may include a roller which applies downward pressure on a top surface of upper plate  710 . Latch release button  730  may control movement of pressure member  725 . One or more tie wires  735 , coupled to base plate  715  and upper plate  710 , may limit the separation distance of ends of base plate  715  and upper plate  710  opposite hinge  740 . 
         [0037]    The apparatus, as depicted in  FIG. 8 , may also include a ratchet handle  830 . Ratchet handle  830  may include base  840  which may be coupled to a surface of upper plate  710 . A series of cords (or wires)  810  may be disposed between base plate  715  and upper plate  710 . An end of each of cords  810  may be coupled to a surface of base plate  715  and extend about portions of fluid bag  310 . Another end of each of cords  810  may be passed through guide  815  and attached to ratchet strap  825 . Ratchet strap  825  may engage with a pawl arrangement (not shown) at base  840  of ratchet handle  830 . Ratchet handle  830  may be moved back and forth, and when ratchet handle  830  pivots to the right in  FIG. 8 , ratchet handle  830  may tighten ratchet strap  825  in the direction depicted by arrow  835 . As ratchet strap  825  moves in the direction depicted by arrow  835 , this motion may pull cords  810 , causing upper plate  710  to pivot toward base plate  715  and compress fluid bag  310 . 
         [0038]      FIGS. 9A-B  show separate perspective views of portable lavage apparatus  900  in two different positions.  FIG. 9A  depicts portable lavage apparatus  900  with pressure block  940  in an open position with spring  945  is compressed.  FIG. 9B  depicts portable lavage apparatus  900  with pressure block  940  in a closed position when single spring  945  is extended. Portable lavage apparatus  900  may include a base plate  950  with the fluid bag  310  disposed on base plate  950 . Pivot member  915  may be coupled to base plate  950  and include side legs  930  each having respective elongated slots  920  that receive pins  955  of pressure block  940 . One end of spring  945  may be coupled to base plate  950  and an opposite end of spring  945  is coupled to pressure block  940 . 
         [0039]    As pivot member  915  pivots downwardly, pressure block  940  moves along the slots  935  and applies force to fluid bag  310 . As the fluid bag  310  is compressed, the fluid in fluid bag  310  flows through the outlet tubing  135 . 
         [0040]    As shown in  FIG. 10 , a yoke  910  may be rotatably coupled to base plate  950 , and may comprise upper piece  1110  and lower piece  1120  as illustrated in  FIG. 11 . Yoke  910  may retain outlet  510  of fluid bag  310 , holding outlet  510  and thus the fluid bag  310  in a given position. Yoke  910 , as illustrated in  FIG. 10 , may preferably fold downward in a direction shown by arrow  1010 , providing a compact and relatively thin support apparatus. Upper piece  1110  of yoke  910  may be removed or pivoted away from lower piece  1120  (i.e., to an open position). When yoke  910  is in the open position, fluid bag  310  may be inserted into or removed from yoke  910 . When upper piece  1110  of yoke  910  is in a closed position, yoke  910  holds fluid bag  310  in position as shown in  FIG. 11 . 
         [0041]    In various embodiments as illustrated in  FIG. 12 , the mechanism used to compress the fluid bag  310  may include one or more straps or cords  1210 . Cords  1210  may be disposed about fluid bag  310  and may be tightened by manual or mechanical mechanisms. One exemplary tightening mechanism is a ratchet member  1220 . Ratchet member  1220  may be used to advance cords  1210 , so that cords  1210  are tightened around fluid bag  310 . Cords  1210  may comprise, for example, a flexible or elastic material (e.g., nylon) and may comprise an interior core (i.e., kern) and an exterior sheath (i.e., mantle). 
         [0042]    As depicted in  FIG. 13 , the apparatus may further include a ratcheting buckle  1310  coupled to upper plate  710 . The ratcheting buckle  1310  may be activated to draw ratchet strap  1320  through ratcheting buckle  1310 . Activating ratcheting buckle  1310  may pull cords  1340  and move upper plate  1340  toward base plate  715  to apply pressure to the fluid bag  310 . Ratcheting strap  1320  may not be coupled to base plate  715 , but may be ratcheted through a lower portion of ratcheting buckle  1310 . In operation, an upper portion of ratcheting buckle  1310  may be activated by hand, foot, or knee to draw ratcheting strap  1320  in the direction indicated by arrow  1325 . 
         [0043]    An important element of first aid procedure in the field is the intravenous (IV) replacement of fluids. In some instances, the injured/wounded person may be losing fluids at such a high rate that a high pressure IV is required. So while 100 cm head pressure is adequate for low pressure IV, high pressure IV may require  300  cm head pressure or more. It will be recognized by those skilled in the art that these pressures are illustrative only. Operating conditions and requirements will determine the actual pressures that may be used. 
         [0044]    Because of the variable pressures that may be required, a pressure variation and control mechanism may be included in the fluid flow line.  FIGS. 14A-C  illustrate several mechanisms by which this may be accomplished.  FIG. 14A  shows the fluid bag  310  coupled to an in-line pressure reducer  1401 . The spring bias mechanism of the lavage apparatus may still be used to apply pressure to the fluid bag  310 . The in-line pressure reducer  1401  may be used to reduce the pressure to a usable level. Because the fluid in fluid bag  310  may be under pressure, fluid bag  310  does not necessarily have to be hung in an elevated position to be used. 
         [0045]      FIG. 14B  shows another example of a pressure control mechanism. The pressure reducer  1402  includes a thumb roller  1403  which allows the user to vary the pressure of the fluid flowing through dispensing hose  150  by manipulating the thumb roller  1403 .  FIG. 14C  illustrates another pressure control mechanism, a pressure reducer  1404  that may be adjusted by manually twisting the reducer  1404 . 
         [0046]    The above examples are set forth for illustrative purposes and are not intended to limit the spirit and scope of the invention. One having skill in the art will recognize that deviations from the aforementioned examples can be created which substantially perform the same tasks and obtain similar results. For example, instead of compressing a fluid bag to release fluid, the embodiments described above may distend the fluid bag to create suction or vacuum. The vacuum may, for example, be used for negative pressure wound therapy (NPWT).