Closeable, disposable wound care system

A receptacle for controlling and containing irrigation fluids administered to clean and irrigate a wound on a patient's body. The receptacle comprises a thin flexible film selected from the group consisting of polyethylene and polyvinyl chloride, and having an adhesive portion for sealing to the patient. The receptacle is in the form of a bag member and is utilized for retaining fluids along with a spraying or irrigation member, thereby enabling the wound irrigation procedure to be carried out in a closed system, and wherein upon completion of the procedure, the receptacle may be completely sealed and disposed of in an appropriate manner so as to avoid cross-contamination from a patient being treated to another person such as a health care professional or another patient.

BACKGROUND OF THE INVENTION 
The present invention relates to receptacles, and more particularly, to 
receptacles used in the collecting, transporting, storing and disposing of 
fluids used in the medical field for cleaning and irrigation of acute and 
chronic wounds on the bodies of patients. 
The present medical practice is typically to wash or irrigate wounds with a 
stream of fluid. Such fluids are normally of sterile, normal saline, soap 
and water, a variety of povidone/iodine and/or other antiseptic, 
antibiotic, or anesthetic solutions. In the present practice, a stream of 
flow is directed to the wound from an arrangement comprising a standard 
medical type syringe or IV tubing. This arrangement may or may not have a 
stop cock attached thereto, and may be driven by a powered member in the 
form of a hydraulic system commonly referred to as a water pik. In the 
past, the irrigating fluid would be splashed onto the wound surface with a 
moderate amount of force sufficient to dislodge dirt, debris, bacteria, or 
dead tissue. In this procedure, some fluid would ricochet from the wound 
surface and drip either to an open waiting bag, or onto some absorbent 
cotton bandages. At the completion of the procedure, the cotton bandages 
would be disposed of by placing them within a bacterial and viral-proof 
bag usually consisting of polyethylene or other suitable non-porous or 
substantially impermeable film and disposed of in a safe and sterile 
manner. The advent of blood-borne diseases that can be transmitted by the 
transfer of body fluids from a patient to a health care professional or to 
another patient via contaminated airborne particles (fomites) makes a 
closed system for such irrigation procedures imperative. Further, OSHA 
(Occupational Safety and Health Act of 1970) 29CF.sctn. 1910.1030, 
requires universal precautions since all body fluids are to be considered 
potentially infectious. As such, they are characterized as regulated waste 
and must be placed in a closeable container. 
SUMMARY OF THE INVENTION 
In one typical configuration, the apparatus of the present invention 
consists of a bag or enclosure of thin plastic film such as polyethylene 
which is inherently heat sealable and having an outer perimeter that is 
welded along a continuous bead, and with a portion of the bag having an 
adhesive surface protected by a glazed paper to accommodate shipping and 
handling. A single hole is provided in the bag along the adhesive surface. 
In use, an irrigation or spraying member is passed through the hole and a 
source of irrigation fluid pressed through the film opposite said hole, so 
that attachment of the spraying member to the irrigation fluid source 
would form a reasonably sound seal. The gasket between the two members is 
formed from the perforated wall of the receptacle itself. After assembly, 
the protective glazed paper is peeled from the adhesive surface and the 
adhesive surface placed against an uninjured area or zone of the patient's 
body in such a way as to create a seal around and isolate the wound. The 
size of the fenestration may be increased by simply extending the 
fenestration by cutting a portion thereof, so that the hole would be 
slightly larger than the wound. After sealing to the surface of the skin 
of the patient, irrigation and spraying can commence with any ricocheting 
fluid or after-spray being retained within the receptacle member and 
collected by gravity at the bottom. After irrigation is complete, the 
receptacle member is separated from the patient. If the irrigation system 
were undertaken using a simple disposable tubing member, it is placed 
within the receptacle through the wound hole and thereafter the adhesive 
portion is folded over to adhere to the receptacle wall in such a way as 
to create a complete seal with the original hole being completely 
isolated. In this way, the entire contents of the receptacle remain 
isolated and sealed within the container for safe and sterile transport to 
appropriate disposal and incineration. 
Alternatively, and in another configuration, the device consists of a bag 
member with an adhesive means covering a portion of the surface, and with 
a protective glazed paper over the adhesive for shipping and handling. In 
approximately the middle of this adhesive portion, a fenestration or a 
window is created by partial perforation of the glazed paper adhesive and 
the receptacle member to permit ease of removal at the time of use. In 
this configuration, instead of having the welding bead formed along the 
entire perimeter, a portion is left unwelded. The enclosure is then open 
mouthed, such as a common bag, but a sealable means is provided adjacent 
the opening so that, in this configuration, the device can be adherent to 
the skin surface around a wound. The opening gives ready access to the 
wound for suturing, disinfecting, irrigation, or otherwise treating the 
wound. Items such as used sutures, bandages, dressings and irrigation 
fluid are then collected in the receptacle portion and after completion of 
the suturing and/or irrigation process, the mouth of the bag may be 
sealably closed. 
Therefore, it is a primary object of the present invention to provide an 
improved device which functions as a closed wound irrigation system and 
sealable fluid retaining receptacle to prevent cross-contamination from a 
patient being treated to another person. 
It is yet a further object of the present invention to provide an improved 
wound irrigation system fabricated from a pair of flexible wall film 
members, heat sealed or otherwise welded about their periphery, having an 
adhesive surface with a hole therein to allow the attachment of an 
irrigation system, with the irrigation system being a simple intravenous 
fluid tubing member and stop cock or needle, a simple irrigating syringe, 
or a syringe with a renewable source of irrigating fluid, or a hydraulic 
or pneumatic mechanically or electrically operated pumping system. 
It is yet another object of the invention to provide a single receptacle 
that is acceptable for virtually all routine wound irrigations. 
Still a further object of the invention is a provision of a receptacle that 
is closable and disposable but not susceptible to breakage. 
It is yet a further object of the invention to provide a receptacle that is 
easily hermetically sealed to avoid leaking and contamination. 
Still an additional object of the present invention is to provide a 
receptacle that comprises a sealable, closeable, attachable receptacle 
means having an opened end to allow access to the wound for debridement, 
suture, or other wound care such that following such care, an irrigation 
system may be attached to the wall of a device having a sealable means to 
allow all of the debris of the suture debridement and irrigation collected 
in the receptacle member and sealed for appropriate disposal and 
decontamination. 
It is yet another object of the present invention to provide a labeling 
identification system for identifying and disposing of certain types of 
medical waste. 
Various other objects and advantages will appear from the following 
description of several embodiments of the invention, and the most novel 
features will be particularly pointed out hereinafter in connection with 
the appended claims.

DESCRIPTION OF THE PREFERRED EMBODIMENTS 
In accordance with the preferred embodiment of the present invention, and 
with particular attention being directed to FIGS. 1 and 5, there is 
illustrated a receptacle generally indicated at (10), constructed of film 
or other flexible sheet-like material, preferably polyethylene. Typically, 
polyethylene film is used having a thickness of between one-half and two 
mils, with one mil polyethylene being generally preferred. The receptacle 
(10) is heat welded or otherwise joined at its periphery (11) to form a 
continuous seal. An adhesive material (12) is disposed along an upper 
periphery of one surface of the receptacle (10) for adhering the 
receptacle (10) to a patient. This surface, referred to hereinafter as the 
adhesive patient surface (12), is protected and covered prior to use by a 
sheet of glazed paper (13). A single fenestration or hole (14) is formed 
through the receptacle (10) within the adhesive patient surface (12). In 
FIG. 1, the protective glazed paper (13) is shown partially peeled back at 
the corner (see peeled back portion (131)) exposing the adhesive patient 
surface (12). In FIG. 5, spent irrigation fluid (52) is shown at the 
bottom portion of the receptacle (10) and with the adhesive patient 
surface (12) being placed in juxtaposition to the outer surface of the 
receptacle (10) at the end opposite the reservoir fluid (52). This permits 
the fenestration (14) and the irrigator puncture site (15) to be 
completely sealed, thereby preventing leakage or escape of the fluids (52) 
and other items contained therein. 
In FIG. 2, the receptacle member (10) is shown with an irrigation source, 
shown generally at (24), comprising an irrigation spray nozzle (30) in 
line to be attached to an irrigation source lock (22) having a plurality 
of inlet ports (27) and an outlet port (25). As shown in FIG. 2, the inlet 
ports (27) are coupled to a syringe (20) and a fluid supply tube (23), 
while the outlet port (25) is in line to be attached to the irrigation 
spray nozzle (30). The irrigation source lock (22) may be any one of 
several commercially available stop cocks or syringe fittings. In use, the 
outlet port (25) of the irrigation source lock (22) is piercingly forced 
through the wall of the receptacle (10) opposite the fenestration (14) as 
at (15) to interlock with a flange member (31) of the spray nozzle (30) 
such that the stretched wall of the receptacle (10) serves as a gasket. 
The fluid supply tube (23) is disposed to provide fluid communication 
between the irrigation source lock (22) and a fluid source (not shown). 
The fluid source may be a simple sterile irrigation fluid bag or bottle 
which may traverse under the influence of gravity through the irrigation 
source lock (22) into the spray nozzle (30) to be sprayed upon the wound 
(not shown). Alternatively, the fluid source may simply be the syringe 
(20) having a plunger mechanism (21) that can be manually or mechanically 
operated to provide the necessary and appropriate force to spray the 
irrigating fluid through the spray nozzle (30). 
With attention now being directed to FIG. 3, the assembled wound irrigation 
system as illustrated is adherent to a patient (40) for a wound (41) on 
the patient's hip. 
With attention now being directed to FIG. 4, the alternative preferred 
embodiment of the invention illustrated is shown in place with the 
adhesive patient surface (12) being disposed adjacent the patient's arm 
(40). In this case, the adhesive patient surface (12) encompasses the 
entire wrist wherein the hand has been placed through the fenestration 
(14). The irrigation fluid, shown entering the fluid supply tube (23) as 
at (50) passes through the outlet port (not shown) of the irrigation 
source lock (22) and further through the irrigation spray nozzle (30) 
after being directed between the fluid supply tube (23) and the syringe 
(20) by the irrigation source lock (22). In the preferred embodiments 
shown in FIGS. 2-4, the irrigation source lock (22) is a commercially 
available fitting for attachment to the syringe (20) and the fluid supply 
tube (23). The irrigation source lock (22) is thus capable of directing 
the fluid from the fluid source (not shown) into the syringe (20) 
responsive to the outward movement of the syringe plunger (21), as well as 
directing the fluid within the syringe (20) out the nozzle (30) responsive 
to the inward movement of the syringe plunger (21). After coming in 
contact with the wound (41), the irrigation fluid is sprayed as droplets 
(51) and collected at the lower periphery of the receptacle (10), as shown 
at (52). 
In actual operation and in carrying out the procedure with the use of the 
present invention, the protective releasable glazed paper member or film 
(13) is removed from the adhesive patient surface (12), with that portion 
of the receptacle (10) being placed into an appropriate area of the 
patient surrounding the wound (41). The size or length of fenestration 
(14) may be adjusted or otherwise modified to accommodate the 
configuration of the wound (41). After use, the receptacle (10) is removed 
from the patient (40) and folded in such a way that the adhesive patient 
surface (12) is removed from the skin of the patient and then doubled over 
and attached to the wall of the receptacle (10) so that the fenestration 
(14) and puncture hole (15) are isolated and sealed from the inner portion 
of the receptacle (10), thereby isolating its contents (52). 
With attention now being directed to FIG. 6 of the drawings, shown is an 
alternate embodiment of the present invention, wherein the receptacle (10) 
is provided with heat sealed or welded seams (11) that extend a 
predetermined distance along the lateral edges of the receptacle (10) to 
provide an opening, shown generally at (18), capable of receiving spent 
irrigation fluid or debris (52) disposed and retained in the bottom of the 
receptacle (10). In this embodiment, flap member (16) has an adhesive 
surface (17) which faces the fenestration (14). In practice, releasable 
glazed paper or film (13) is disposed on the adhesive surface (17) for 
isolation and protection until after use. At that time, adhesive patient 
surface (12) may be separated from a patient and rolled into the opening 
(18) of the receptacle (10). When the protective glazed paper (13) is 
removed from the adhesive surface (17), the flap member (16) may be folded 
down to be sealably and closeably attached to the opposite side of the 
receptacle (10), thereby isolating and retaining the contents (52) 
therein. 
With attention now being directed to FIG. 7, shown is a side view of the 
alternative embodiment in FIG. 6 prior to use with the glazed releasable 
paper (13) remaining disposed on both the adhesive patient surface (12) 
and the adhesive surface (17) of flap member (16). The sealable, closeable 
opening (18) is illustrated here in its open position. 
With attention now being directed to FIGS. 8 and 9 of the drawings, shown 
is another preferred embodiment of the present invention, wherein the 
adhesive patient surface (12) extends along a portion of the receptacle 
(10) surrounding the fenestration (14) and further along the underside of 
a flap member (16) that extends away from the top edge of the receptacle 
(10). Following use, this flap member (16) may be folded downwardly to 
cover the lower portion of the adhesive patient surface (12), as shown in 
dotted lines below the fenestration (14), to thereby create a seal over 
the fenestration (14). An interdigitating and mutually coupling closeable 
lock (60) is provided so that the contents of the receptacle (10) may be 
sealed and isolated by obstructing the opening (18). Such interdigitating 
lock means are, of course, commercially available and, as shown in FIG. 9, 
provide selective access to the interior of the receptacle (10) and, 
hence, the wound via the coupling relationship between an outer engaging 
portion (61) and an inner engaging portion (62) of the interdigitating 
lock (60) for suturing, cleaning, and the like. 
With attention now being directed to FIG. 10 of the drawings, there is 
illustrated the device of FIG. 6 during use, wherein the adhesive patient 
surface (12) allows the receptacle (10) to be attached to the surface of 
the skin of the patient (40), giving full and clear access to the wound 
(41) through the fenestration (14). As illustrated herein, flap member 
(16) may be folded downwardly to give full and clear access to the wound 
(41) for suturing, debridement, and/or other indicated wound care. After 
use and collection of all wound related refuse (52), protective glazed 
paper (not shown) is removed from a covering relationship over the 
adhesive surface (17) of the flap member (16). The adhesive patient 
surface (12) is then peeled away from the patient, rolled upon itself and 
stuffed into the opening (18), so that the flap member (16) may be folded 
over onto the opposite surface of the receptacle (10), thereby completely 
sealing the contents (52) and the opening (18) of receptacle (10). 
With attention now being directed to FIG. 11, there is illustrated a 
perspective view of an alternative preferred embodiment of the present 
invention, with the receptacle (10) attached to a patient (40). In this 
embodiment, a sealable, closeable surface or flap member (16) is disclosed 
having an adhesive sealing surface (17) disposed thereon which, during 
use, is covered with a removable protective glazed paper (not shown). 
Following use, the adhesive patient surface (12) is folded upon itself and 
placed within the receptacle (10). The glazed paper (not shown) is then 
removed from the adhesive surface (17) of the flap member (16) so that the 
flap member (16) may be folded over to completely seal and isolate the 
contents (52). 
Another feature of the invention is that it can be fabricated of a material 
such as, for example, vinyl, the surface of which can be modified to 
accept ink and thereby can be easily written upon so as to designate such 
information as the patient's name, source of the material, or bar code or 
other identifying means for tracking of medical waste as currently 
required in many jurisdictions. Other films, including polyethylene, may 
be treated so as to accept certain types of inks, and are, of course, 
commercially available. 
It will be understood that variations, and various and other changes in the 
details, materials, steps and arrangements of parts which have been herein 
described and illustrated in order to explain the nature of the invention 
may be made by those skilled in the art within the principle and scope of 
the invention.