Abstract:
A collapsible fluid containment bag for irrigating and cleaning wounds on extremities having semi-rigid support members and an elevated lower support member attached to the bottom of the proximal end of the containment bag creating a gradient for allowing irrigation fluids and biological tissue to drain to the distal end of the bag for removal. The containment bag is collapsible, making it a convenient size for storage, transport, and disposal.

Description:
FIELD OF THE DISCLOSURE 
       [0001]    The invention relates generally to a wound irrigation/fluid containment system that isolates a wound on a person on which wound treatment is to be performed. 
       BACKGROUND 
       [0002]    The cleaning and washing of wounds is required to remove foreign material and to decrease bacterial contamination. The wound-care provider, whether a first responder, nurse, physician, surgeon, or assistants, should be protected or isolated from bodily fluids and any contaminated irrigation fluids. 
         [0003]    A collection pan or receptacle is usually placed under the wound that is to be treated in order to collect the irrigation fluid used during the irrigation and debridement. Debridement is the removal of foreign matter such as dirt, contaminates, or dead tissue. Irrigation is the flushing of fluid over the wound to remove smaller particles and bacteria to decrease the possibility of infection. 
         [0004]    During irrigation and debridement procedures, often times the fluid is not received in a collection pan. Further, fluid can splash onto the wound-care provider, equipment, and surroundings. In other words, the collection pan placed under the wound usually does 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 infections 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. The spillage of contaminated irrigation fluid requires sterilization of the materials in the immediate environment, which could include carpeting, walls, bed coverings, etc. 
         [0005]    Therefore, there is a need for a fluid containment system that provides a barrier to the wound-care provider to the splash or spillage of contaminated irrigation fluids or body fluids. This system must contain and collect body and irrigation fluids. It must enclose them for the safety of the wound-care provider and provide adequate means for removing the irrigation fluids and biological tissue without restricting the activities of the wound-care provider. An additional need is evident for a containment device that can be reduced to a convenient size for storage, transport, and disposal. 
       DESCRIPTION OF THE PRIOR ART 
       [0006]    U.S. Pat. No. 5,312,385 describes a collapsible enclosure for covering a limb for providing pulse irrigation to a wound thereon. An enclosure with inflatable ribbing, at least one outlet port, one opening for insertion of a body part, and an opening in the enclosure for providing access for a pulse irrigation nozzle is disclosed. 
         [0007]    U.S. Pat. No. 5,316,541 describes a disposable, collapsible tent with a support structure for supporting the tent and an adhesive means for securing the tent to the patient&#39;s body. Gloves are formed from the wall of the tent so a surgeon may place his hands therein for manipulating surgical instruments and performing surgical procedures on the patient. A surgeon can operate on the patient by making an incision through the enclosure via use of the assembly on the patient&#39;s skin. The incision in the patient&#39;s body fluids are contained within the isolated cavity defined by the enclosure. 
         [0008]    U.S. Pat. No. 5,608,163 describes a metal basin including a grid for supporting a limb enclosed in a free-standing transparent plastic enclosure. The basin collects irrigation fluids that are dispensed by a care giver whose hands are inserted through apertures in the side walls of the enclosure. The irrigation fluids are collected in the bottom of the basin for disposal. 
         [0009]    U.S. Pat. No. 5,178,162 describes a fluid containment device that attempts to isolate an extremity of the body and provide drainage means for fluids used during irrigation and to allow access to the extremity by the surgeon to perform various functions. 
         [0010]    U.S. Pat. No. 5,437,602 describes a fluid containment device using fenestrations or access ports for the surgeon that has apertures for inserting nozzles and another resealable opening for access to the extremity being treated. Removal of irrigation fluids is accomplished by manipulating a drainage plug in the bottom of the device. Vacuuming is required to remove the irrigation fluids, which would effect the collapse of the containment device. 
         [0011]    It is desirable to provide a containment device for applying irrigation fluids and for debridement treatment that allows for the efficient drainage of the fluid or tissue to a drainage area for removal while providing protection to a wound-care provider. 
       SUMMARY OF THE INVENTION 
       [0012]    The present invention describes a collapsible fluid containment device allowing for isolation of those in the vicinity of the irrigation of a patient or debridement of wound tissue on a patient from contaminated irrigation fluid or tissue. Generally, the collapsible fluid containment device of the present invention includes a flexible bag body for defining a containment space, the bag body comprising a wall having a proximal end, a distal end, and a drainage area at the distal end, the wall including semi-rigid structural support members and an elevated lower support member positioned under the proximal end to create a gradient so that fluids and dislodged biological matter will migrate by gravity to the drainage area at the distal end for removal and disposal. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]    The invention will now be described by way of example only with reference to the following drawings: 
           [0014]      FIG. 1  is a side view of a fluid containment device in a folded position for storage or disposal. 
           [0015]      FIG. 2  is a top view of a fluid containment device surrounding a patient&#39;s leg. 
           [0016]      FIG. 3  is a cross-sectional side view of a fluid containment device showing that the proximal support is in a position that is elevated from the distal support to allow draining of fluids collected in the device. 
           [0017]      FIG. 4  is a cross-sectional view of a fluid containment device taken along lines  4 - 4  of  FIG. 3 . 
           [0018]      FIG. 5  is a cross-sectional view of a containment device taken along lines  5 - 5  of  FIGS. 3 and 6 . 
           [0019]      FIG. 6  is a side view of another embodiment of a fluid containment device showing a single collection tube for receiving irrigation fluid, thereby allowing the fluid to drain from the containment device. 
           [0020]      FIG. 7  is a perspective view of a folded or collapsed fluid containment device placed in a package for storage and/or transport. 
       
    
    
     DETAILED DESCRIPTION 
       [0021]    Referring now to  FIGS. 1-7 , the present invention is a fluid containment device  10  illustrated in the figures and including the following components, namely, bag body  12 , having a lower section  14  and an upper section  16 . The fluid containment device  10  includes bottom  18  and continuous wall  20 . The fluid containment device  10  can be made from one-piece clear plastic, such as polyvinylchloride, or can be manufactured from multiple pieces, including a separate floor, sidewalls, and top. The bottom and sidewalls define a proximal opening  22  in which a patient&#39;s limb may be inserted for care and treatment at proximal end  23 . Distal portion  24  defines an area where tubing, hosing, or other means enter bag body  12  for removal of irrigation fluids and biological tissue from drainage area  25 . 
         [0022]    The shape of the fluid containment device  10  is maintained with flexible, semi-rigid supports  26 , which support the bag body and fluid containment device so that the patient&#39;s limb may be inserted therein. The flexible support members define containment space  28 , which can receive the patient&#39;s limb for irrigation, wound treatment, debridement, or subsequent surgical procedures. Semi-rigid flexible structural support member  26  may engage fluid containment device  10  in any practical or conventional manner. However, it is preferred that the walls  20  and the lower section  14  and the upper section  16  of bag body  12  contain a double-wall sleeve  27  defining an opening for insertion of the flexible support member  26 . The two-sided sleeve comprises an outside wall  30  comprising the bag body  12  and wall  20 . It also comprises a lower side  32  defining open space  34  for insertion of the semi-rigid flexible support member  26  as illustrated in  FIG. 4 . The structural support member has a rounded shape approximately a semicircle when operatively associated with continuous wall  20  and bottom  18 . The semi-rigid flexible support member  26  is made from suitable material for providing flexibility for opening the containment device  10  from a collapsed position  72  and an open position for supporting containment device  10  creating containment space  28 . The structural support member  26  also must be sufficiently flexible to be compressed into a collapsed position  72  for storage in a container or package  74 . Further, the material utilized in manufacturing the structural support member  26  must be an approved material that can withstand sterilization treatment of the containment device  10  prior to use. Many conventional materials, including various plastics may be utilized, however, polypropylene is preferred. 
         [0023]    In addition, fluid containment device  10  may contain access ports  36  wherein one or more may be placed on the upper section of the bag body or in any other convenient location. The access ports  36  provide access to the body for the care provider and can be resealed. Zippers are illustrated. However, any conventional closure means is acceptable. 
         [0024]    Fluid is drained or withdrawn from the bag body  12  by tube  38 , which may have one or more extension tubes. The tubes enter the bag through port  40  at distal end  24 . One tube  42  may enter the bag for collection of fluids that may drain through that area of the bag. Indeed, one or more perforated tubes  44  descending into the bag, preferably to the proximal end  23  or opening  22  for collection of fluids, may be utilized. It is preferred to have perforations  46  in the tubes for collecting fluids and tissue as they drain toward tube  42  and drain  48 . Drain  48  includes a funnel device  50  having a set diameter  52  connected to hose  54 . The large diameter  52  of the funnel and large diameter  56  of hose  54  allows for the insertion of tube  42  or perforated tube  44  therein, creating a double-walled tube  58 . A vacuum pump (not shown) can be attached to double-walled tube  58  to remove liquid and biological tissue through perforated tube  44 . Further, drain  48  may capture liquids and tissue as they collect in the bottom  18  of distal portion  24  of bag body  12 . The funnel shaped device  50  assists in the collection of liquids and tissue. When vacuum is applied, it assists in the removal of liquids and tissue through hose  54  also, which is surrounding perforated tube  44 , as well as through perforated tube  44 . 
         [0025]    An especially useful feature of the present invention is lower support  60 , which is attached to bottom  18  in the lower section  14  of the fluid containment device  10  for elevating the limb of the patient at the proximal end  23  of the device. Support  60  runs the width of bottom  18 . By elevating the limb, a gradient is created allowing gravity to assist the flow of irrigation fluids and tissue to the port  40  for removal from the bag. To assist in the removal of irrigation fluids and tissue from the bag, the tube  36  and perforated tubes  44  may be subjected to vacuum pressure. 
         [0026]    Lower support  60  may be made from any lightweight, sturdy material, for example, polystyrene, that is fitted within sleeve  62  and the floor  18  of the fluid containment device  10  as shown in  FIG. 5 . Sleeve  62  has outer wall  64  defining open space  66  wherein lower support member  60  is inserted. Lower support  60  also provides comfort to the patient by providing support to the limb. Any suitable means for closing the device at its proximal end to secure the device to the patient&#39;s limb may be utilized. It is preferable, however, to use hook and loop fastening means  29  for convenience. 
         [0027]    Referring to  FIG. 1 , fluid containment device  10  is shown in a collapsed or folded position  72 . In position  72 , the device may be stored for transportation.  FIG. 7  shows a container or package  74  that has a flat bottom  76  and rounded surface wall  78  that matches the contour of the folded fluid containment device  10 . More specifically, wall  78  matches the contour of the folded structural support members  26 . The package  74  provides convenient, sterile and secure storage of fluid containment device  10  for transport. The folded position  72  of the containment device provides less space for transportation of sterile devices. In addition, package  74  may be used to transport a contaminated fluid containment device  10  with irrigation fluid and tissue for disposal. The combination of the containment device  10  and storage package  74  provides a convenient solution for proper handling and disposal of contaminated irrigation fluid and biological tissue. 
         [0028]      FIG. 2  illustrates a top view of the fluid containment device  10  with a patient&#39;s leg inserted therein to illustrate perforated tubes  44  extending from the distal end of the bag body  12  to the proximal end  23  for the collection of fluids and other materials. Drain  48  is shown for collecting fluid at the distal portion  24  in bottom  18  of the bag because of the gradient created by the use of lower support  60  (not shown) at the proximal end  23  of the fluid containment device. 
         [0029]      FIG. 6  illustrates a shorter version  11  of containment device  10  with two semi-rigid support members  26 . 
         [0030]    It should be apparent to those skilled in the art that various modifications and adaptation of the structure described above are possible without departing from the spirit of the invention, the scope of which is defined in the appended claims.