Abstract:
A wound irrigation/fluid containment system having a flexible bag body defining a containment space, the bag body including walls and at least one opening with a seal, means for accessing through the bag body walls to the containment space and means for inflating portions of the walls to provide rigidity and strength to the walls. The containment device isolates a wound on a person and is capable of draining fluids away from the wound.

Description:
This application claims the benefit of priority to U.S. Provisional Application No. 60/437,444 filed Jan. 2, 2003. 

   FIELD OF THE INVENTION 
   The invention relates generally to surgical devices and more particularly to a wound irrigation/fluid containment system (WICS) that isolates a wound on a person upon which wound treatment is to be performed. 
   BACKGROUND OF THE INVENTION 
   Standard treatment for all wounds requires cleansing or washing to remove foreign material and to decrease bacterial contamination. Safety considerations require isolation of the wound-care-provider (first responder, nurse, physician, surgeon, assistants) from body fluids and any contaminated irrigation fluid. 
   Debridement is the removal of foreign matter such as dirt, glass or dead tissue, whereas irrigation is the flushing of fluid over the wound to remove smaller particles and bacteria to decrease the possibility of infection. A collection pan or receptacle is placed under the wound that is to be treated in order to collect the irrigation fluid used during the irrigation and debridement process. 
   It is not uncommon that during irrigation and debridement procedures that fluid can plash onto the wound-care-provider, equipment and surroundings. In other words, the collection pan placed under the wound usually will not catch all of the irrigation or wound fluids that are present during the irrigation and debridement procedure. This is of particular concern should the patient have blood-borne infection such as HIV, Hepatitis or Cytomegalovirus, thereby putting the wound-care-provider at risk of contracting an infectious disease. There are times when a patient may not be aware that they have contracted an infectious disease and hence the adoption of universal precautions has been recommended. 
   Therefore, there is a need for a fluid containment system that provides a barrier to the wound-care-provider to splash of contaminated irrigation fluids or body fluids. This system must contain body and irrigation fluids, as completely as possible, collect, enclosed and allow safe and complete drainage of said fluids, but yet allow freedom of movement of the wound-care-provider to be able to attend to the patients needs without undue restrictions. 
   DESCRIPTION OF THE PRIOR ART 
   U.S. Pat. No. 5,178,162 titled Splash and Spill Resistant Extremity Irrigation and Debridement Fluid containment device granted Jan. 12, 1993, filed by inventor William Jo. Bose on Apr. 14, 1992 describes a fluid containment device which attempts to isolate an extremity of the body and provide for a drainage means for fluids used during irrigation and to allow access by the surgeon to perform various functions. The fluid containment device depicted and described in U.S. Pat. No. 5,178,162 contemplates the use of fenestrations or access ports for the surgeon, including apertures for nozzles and as well a resealable slit or opening for access to the affected extremity during surgery. In addition, there is a drainage plug which is used for the removal of irrigation fluids as they are applied to the patient. 
   In practise this fluid containment device is impracticable because it tends to collapse particularly when any vacuum is applied to the drainage plug to remove the irrigation fluids. In order to prevent collapsing of this fluid containment device, the amount of suction applied to the drainage plug is minimized or avoided completely until after the surgery is complete, at which time a vacuum can be applied and the fluid removed. With this drape all fluids can not be removed because of pockets of fluid which become isolated from the vacuum source. 
   The present invention address these issues and provides for a bag which maintains some rigidity or shape and provides resistance to collapsing of the fluid containment device or drape itself and also provides for a more complete evacuation of irrigation fluids that may become trapped in between the membrane walls of the fluid containment device by use of special surface textures of the membrane itself 
   SUMMARY OF THE INVENTION 
   The present invention a fluid containment device comprises: 
   A fluid containment device comprising: 
   a) a flexible bag body defining a containment space; 
   b) said bag body including walls and at least one opening, said opening including a means for sealing off said end; 
   c) a means for accessing through said bag body walls and into said containment space; and 
   d) a means for inflating portions of said walls to provide rigidity and strength to said walls. 
   Preferably further including a means for draining fluids captured within said containment space. 
   Preferably wherein said bag body comprised of at least two flexible membranes. 
   Preferably wherein said bag body including an inner membrane and an outer membrane disposed adjacent each other to form a double layered wall. 
   Preferably wherein said inflating portions defined by the space between said inner and outer membranes. 
   Preferably wherein said inflating portions comprising inflatable chambers extending between sealed locations where said outer and inner membranes are sealed together. 
   Preferably wherein said inflatable chambers including horizontal inflatable chambers and vertical inflatable chambers. 
   Preferably wherein said inflatable chambers being tubular in shape. 
   Preferably wherein said membranes including an inner dimpled surface such that when said bag body collapses onto itself voids are formed between said bag walls forming drainage pathways for any entrapped fluids in said fluid containment device. 
   Preferably wherein said sealing means including Velcro® male and female connectors for sealing off said collar around or against a body part. 
   Preferably wherein said sealing means including adhesive means for sealing off said collar around or against a body part. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The invention will now be described by way of example only with reference to the following drawings as follows: 
       FIG. 1  is a schematic perspective upright frontal view of the wound irrigation/fluid containment system. 
       FIG. 2  is a schematic partial cut away view of the fluid containment device taken along lines  2 — 2  of  FIG. 1 . 
       FIG. 3  is a schematic cross-sectional view taken along lines  3 — 3  of  FIG. 1 . 
       FIG. 4  is a schematic perspective upright view of the fluid containment device shown in  FIG. 1  together with placement of as a leg therein, 
       FIG. 5  is a schematic perspective upright view of the fluid containment device shown in  FIG. 1  together with placement of an extremity such as a leg therein and in addition showing an instrument and a hand being placed through the access ports. 
       FIG. 6  is a schematic perspective upright view of an alternate geometry of the fluid containment device wherein the bag takes on a rounded shape verses the square shape as shown in  FIG. 1 . 
       FIG. 7  is an enlarged cross-sectional view of the inner membrane showing a dimpled surface structure. 
       FIG. 8  is a schematic enlarged cross-sectional view of two inner membranes contacting each other showing the membranes in the collapsed position. 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
   Referring now to  FIGS. 1 through 6  in particular, the present invention a fluid containment device shown generally as  20  includes the following major components, namely bag body  22  having a lower section  24  and an upper tapered section  26 . Fluid containment device  20  includes bottom  28 , walls  31  including side walls  30  and tapered walls  32 , culminating and attached to a collar  34  defining an opening  36  which can be adjusted with velcro fastener  38 . 
   The shape of fluid containment device  20  is maintained with horizontal inflatable chambers  40  which are interconnected with vertical inflatable chambers  42 , wherein air can be injected into vertical inflatable chambers  42  as well as horizontal inflatable chambers  40  through air inlet/outlet  44 . Fluid containment device  20  defines a containment space  21  which can receive and house various appendages for subsequent surgical procedures. 
   Optionally fluid containment device  20  includes access ports  46  as well as sealable openings  48  and also is fitted with a drain plug  50  for draining of any liquids which find their way into fluid containment device  20 . 
   Referring now specifically to  FIG. 3  which shows the construction of side walls  30 , it is apparent that side walls  30  are comprised of double layered walls  52  which include an outer membrane  54  and an inner membrane  56 . Two membranes namely, inner and outer membranes  56  and  54  respectively, defines vertical inflatable chamber  42 . For example as shown in  FIG. 3  vertical inflatable chamber  42  is defined by the space between sealed locations  60 . In order to prevent escape of air or other gases from either vertical inflatable chambers  42  or horizontal inflatable chambers  40 , the outer and inner membranes  54  and  56  are sealed off at seal location  60  on either side of vertical inflatable chambers  42 . 
   Referring now to  FIG. 2 , the same structure is used to define both the tapered walls  32 , the bottom  28  as well as side walls  30 . Horizontal inflatable chambers  40  are defined in an analogous manner as vertical inflatable chambers  42 , namely by using an inner and outer membrane  56  and  54  which is sealed off at sealed locations  60  on either side of horizontal inflatable chambers  40 . In other locations other than the sealed locations, the inner and outer membranes  56  and  54  essentially lie adjacent each other to form a double layered wall  52  which defines the bottom  28 , side walls  30  and tapered walls  32 . 
   In Use 
   Referring now to  FIGS. 4 and 5  in particular, in order to use fluid containment device  20 , first of all air is injected into air inlet  44  in order to inflate horizontal inflatable chambers  40  as well as vertical inflatable chambers  42  in order to give rigidity and shape to fluid containment device  20 . Horizontal inflatable chambers  40  and vertical inflatable chambers  42  are all interconnected in the embodiment shown in the attached drawings so that only one air inlet  44  is required to inflate all of the vertical inflatable chambers  42  and horizontal inflatable chambers  40 . In practise it is possible to isolate some or all of the vertical inflatable chambers and horizontal inflatable chambers by supplying them with individual air inlet and outlets as is practical. The horizontal inflatable chambers  40  and vertical inflatable chambers  42  are tube like in structure. Supplying sufficient air pressure within the inflatable chambers provides rigidity to the fluid containment device giving it a certain structure and shape, thereby preventing collapse of fluid containment device  20  during its use in operations. 
   Once fluid containment device  20  is inflated by injecting air through inlet/outlet  44  and into the inflatable chambers, one can then place the extremity of a body as for example a leg  70  as shown in  FIG. 4  into the opening  36  defined by collar  34  of fluid containment device  20 . The hook and loop fasteners  38  can be used to then seal off the upper portion of the extremity or leg  70  as shown in  FIG. 4  such that fluid is prevented from leaking past and out the top of fluid containment device  20 . 
   It is possible to have other sealing arrangements for collar  34 . For example adhesive tape  38   a  may be used to augment or replace hook and loop fasteners, as shown in  FIG. 5 . The collar may be so designed so as to seal off against a flat portion of the body such as a torso or chest with little or no portion of the body entering into containment space  21 . The collar may also be made of rubber or flexible material for sealing off opening  36  or may have some type of draw string mechanism. Persons skilled in the art will recognize that opening  36  may sealed off in many different manners that are known in the art with some examples described above. 
   It is also possible to have two openings namely one at each end of the bag. This variation is not shown in the drawings but would be useful for placing an arm through the bag to work on an upper portion of an arm for example. In this case the bag would be sealed off at an upper portion of the arm and at a lower portion of the arm. 
   Referring now to  FIG. 5 , one can see that various instruments  72  or a hand  74  can be placed through access ports  46  or even through sealable opening  48  in order to work on the injured extremity or leg  70  as shown in  FIG. 5 . 
   Referring now to  FIGS. 1 and 5 ,  46  represents a sealable access port that allows approach by hand  74  but will otherwise remain sealed, preventing exit of fluids. Also, upon withdrawal of hand  74 , port  46  can again become sealed, again, minimizing risk of fluid leakage. 
   In use a vacuum can be applied to drain plug  50  such that during debridement and/or irrigation operations, any liquid that enters fluid containment device  20  can be collected in the bottom  28  of fluid containment device  20  and once the liquid reaches drain plug  50  it can be drained out or evacuated from fluid containment device  20 . The inflatable chambers  40  and  42  resist, collapse of fluid containment device  20  thereby allowing one to continuously drain fluid from fluid containment device  20  during its use in an operation. 
     FIG. 6  depicts a fluid containment device  120  that is not necessarily square or rectangular in shape as shown in  FIGS. 1 through 5 , but can take on other shapes including rounded as shown in  FIG. 6  and any other shape that is practically usable including an elongated bag having various lengths and widths to be able to accommodate various extremities of different shapes. The features and mode of operation of surgical bag  120  are analogous to surgical bag  20 . 
   Referring now to  FIGS. 7 and 8 ,  FIG. 7  depicts a magnified cross-sectional view of inner membrane  56  showing the inner surface  58  having a dimpled or ridged surface  80 .  FIG. 8  shows two inner membranes  56  which have impinged upon each other in a collapsed position  90  showing two dimpled surfaces  80  contacting each other. This will occur for example should a fluid containment device  20  collapse under the suction which is applied to drain plug  50  being so great that it collapses fluid containment device  20  thereby two inner membranes  56  come in contact with each other upon collapse. Two dimpled surfaces  80  contact each other and thereby form voids  82  between the dimples of dimpled surface  80  such that any vacuum applied to drain plug  50  would still be able to extract any liquid found between the two inner membranes  56  and collapsed position  90 . 
   In other words dimpled surface  80  ensures that even if two inner membranes  56  collapse one onto each other as shown in  FIG. 8 , there always remains some voids  82  as shown in  FIG. 8  in collapsed position  90 , such that liquid can be extracted. 
   It should be apparent to persons skilled in the arts that various modifications and adaptation of this structure described above are possible without departure from the spirit of the invention the scope of which defined in the appended claim.