CA2407761A1

CA2407761A1 - Assembly for transferring fluid from a flexible container

Info

Publication number: CA2407761A1
Application number: CA002407761A
Authority: CA
Inventors: Jessica L. Gwozdz; William L. Rudzena; Suellen M. Bigaj; Samuel F. Spitz
Original assignee: Individual
Current assignee: Hospira Inc
Priority date: 2000-06-09
Filing date: 2001-06-08
Publication date: 2001-12-20
Also published as: AU2001266799A1; WO2001095957A2; WO2001095957A3; EP1289578A2; JP2004503302A

Abstract

An assembly suitable for transferring fluid from a flexible container to a wound irrigation site. The assembly comprises a connector having an end capable of being joined to a flexible container containing a fluid, a nozzle end, and a valve between the end capable of being joined to the flexible container and the nozzle end. The nozzle end of the connector is preferably joined to a splashback shield. The end of the connector that is capable of being joined to the flexible container preferably comprises a spike that serves to pierce a seal on the flexible container. In the preferred embodiments, the valve is actuated by pressure, which is typically supplied by a medical practitioner. The pressure actuatable valve is preferably a ball valve. The splashback shield is preferably substantially hemispherical in shape. The splashback shield preferably contains at least one passageway, preferably a plurality of passageways, for allowing spent irrigation fluid to drain from the wound site.

Description

ASSEMBLY FOR TRANSFERRING FLUID FROM A FLEXIBLE CONTAINER
BACKGROUND OF THE INVENTION
1. Field of the Invention This invention relates to the protection of health care personnel from potentially contaminated fluids. More particularly, the invention relates to an assembly for transferring fluid from a flexible container to a wound site. The assembly is capable of utilizing a splashback shield for containing spent irrigation fluids and wound drainage fluids from the wound site.

2. Discussion of the Art In medicine, lacerations must be cleansed prior to closure for two reasons.
First, many lacerations are contaminated by foreign matter, including grass, road parfiicles, grease, animal or human saliva, and the like, and all lacerations are soon colonized by harmful bacteria. These contaminants can foster infection if debridement is not effective. Second, after the initial cleansing to remove the aforementioned 2o contaminants, the constant ingress of blood hinders wound exploration and closure by obscuring the visualization of vital structures. Thus, during wound exploration and again during closure of the wound, meticulous cleansing of the wound is essential.
Accordingly, wounds are cleansed, typically by means of irrigation, in order to create an irrigation stream to mechanically dislodge and remove contaminants, including bacteria, and blood.
Body fluids resulting from procedures such as wound irrigation are frequently splashed or squirted back onto the physician or health care personnel performing the procedure. This is undesirable, especially if the irrigation fluid is contaminated by Human Immunodeficiency Virus, hepatitis Type B or C viruses, or other pathogens 3o capable of transmitting disease by contact with mucous membranes or openings in the skin. Thus, these fluids present infectious hazards to health care personnel.
Methods to cope with this problem have included protective face shields, goggles, or stationary plastic sheeting erected between the operator and his patient. The various goggles and face shields have failed to gain wide acceptance and use due to discomfort, cost, and a need for cleaning between use. The plastic sheet barriers also require cleaning or replacement, lack mobility, and do not prevent the splash of body fluids onto the s forearms of the health care personnel:
Several United States patents disclose splashback shields of one type or another for use in containing spent irrigation fluids and wound drainage fluids.
U. S. Patent No. 4,769,003 discloses an instrument for preventing the splashback of potential infectious fluids and body tissues during wound irrigation as well as for preventing needle impalement injury to patient or ancillary medical personnel.
The instrument comprises a hub having a central bore the proximal end of which will accept the tip of a syringe and which is integrally joined to a narrow diameter tubule extending from the distal end, said tubule being directed down the central longitudinal axis of a transparent, dome-shaped shield. The shield is integrally joined at its proximal end around the hub and gradually enlarges in diameter towards its distal end, terminating in a circular rim. The shield, when placed adjacent to a wound to be irrigated, will effectively contain potentially infectious splashback and prevent the splashback from contacting irrigator or other personnel, as well as profiecting the patient and medical personnel from impalement injury due to contact with a needle. U. S. Patent No.
20 5,224,940 discloses a splash shield for containing contaminated fluids from a wound.
The shield is a transparent dome-shaped body made from a plastic film. The shield can be pierced by a sharp medical instrument, such a hypodermic syringe or scalpel, and the wound cleansing or draining operation takes place under the shield as it is held against the patient. The shield can be held above and spaced from the wound 25 site white the cleansing or draining operation takes place, to intercept and provide protection from splashed or squirted fluids. U. S. Patent No. 5,496,290 discloses a device for the prevention of contamination of medical personnel from a patient's body secretions that may splash back during wound irrigation. The splash shield is substantially circular and made of a transparent rigid material. The splash shield has a 3o flat center region encircled by an outer concave region and a hollow conical protrusion adapted to receive the tip of a syringe. U. S. Patent No. 4,898,588 discloses a splashback shield for use with a hypodermic syringe to prevent high-angle back-splashback, from syringe lavage, into the user's face. The splashback shield comprises a preferably circular sheet of stiff material which is preferably colorless and transparent, having a central tube which is attached thereto and which passes through the center of said sheet and projects on at least one side of said sheet sufficiently to have one end adapted to receive a standard syringe fitting and the other end adapted to receive a standard hypodermic needle. U. S. Patent No. 5,133,701 discloses a disposable pressure wound irrigation device having a reservoir of cleansing solution disposed therein and a pressure chamber for providing a force upon the reservoir such that a liquid stream of cleansing solution is expelled at a constant pressure therefrom.
An aimable outlet nozzle is provided through which the cleansing solution is expelled, the nozzle directing the flow of the cleansing solution to the wound surface.
A release valve is further provided in order to selectively couple the nozzle with the reservoir, such that the cleansing solution may be evacuated therefrom through a passageway formed by a depression of the valve. U. S. Patent No. 5,735,833 discloses a lavage tip for use with a lavage system irrigate living tissue. A fluid tip includes a fluid port and a suction or vacuum port, with the fluid port and vacuum port defining across-sectional area. A shield is connected to the fluid tip which has an open end with a surface area which is substantially larger than the cross-sectional area of the fluid tip.
2o The open end of the shield is configured for placement against the tissue to be irrigated. U. S. Patent No 5,931,820 discloses an apparatus and method for performing gastric lavage utilizing a connector that has a spiked end shaped to mate with a self-sealing outlet of a compressible bag of sterile irrigation fluid and a nozzle end having the shape of a syringe tip. The spiked end of the connector is spiked into the bag of irrigation fluid and an intravenous (IV) catheter attached to the nozzle end.
The bag of irrigation fluid is held and squeezed to direct a stream of irrigation fluid .
through the IV catheter and into the wound. U. S. Patent No. 5,860,947 discloses a device for irrigating a wound wherein a syringe fitted with a two-way check valve is filled via a short fill stem that is dipped into irrigant contained in a basin and expelled 3o through a discharge port. The use of a basin allows the irrigant to be positioned immediately adjacent the wound to minimize movement and allows the irrigant to be drawn into the syringe with minimal effort and concentration.
Several of the devices in the foregoing patents utilize syringes. It would be desirable to avoid the use of syringes because syringes require refilling, which consumes too much time. In a trauma center, excessive consumption of time increases costs. It would also be desirable to provide an irrigation device in which the flow of irrigation fluid can be controlled, so that irrigation fluid, or any other type of fluid, is not wasted. It would also be desirable to develop a splashback shield that does not hinder the wound irrigation process. Some splashback shields known in the art tend to form a seal against the skin. This seal hinders the wound irrigation process.
SUMMARY OF THE INVENTION
~5 This invention provides an assembly suitable for transferring fluid from a flexible container to a wound irrigation site. The assembly comprises a connector having an end capable of being joined to a flexible container containing a fluid, a nozzle end, and a valve between the end capable of being joined to the flexible container and the nozzle end. The nozzle end of the connector is preferably joined to a splashback 2o shield. The end of the connector that is capable of being joined to the flexible container preferably comprises a spike that serves to pierce a seal on the flexible container.
In the preferred embodiments, the valve is actuated by pressure, which is typically supplied by a medical practitioner, such as, for example, a physician or a 25 nurse. The pressure actuatable valve is preferably a ball valve. The splashback shield is preferably substantially hemispherical in shape. The splashback shield preferably contains at least one passageway, preferably a plurality of passageways, for allowing spent irrigation fluid to drain from the wound site.
This invention provides several advantages over wound irrigation devices 3o known in the art. First, the valve mechanism allows the medical practitioner to restrain the flow of fluid until the assembly is in place over the wound. Second, the at least one passageway in the splashback shield allow the medical practitioner to remove spent irrigation fluid without removing the assembly from the vicinity of the wound.
Third, the assembly eliminates the need for a syringe to propel the irrigation fluid under pressure to the wound. Fourth, the assembly allows the medical practitioner to irrigate the wound without pausing to refill a syringe, thereby saving time. Fifth, the valve allows the medical practitioner to position the assembly without wasting an excessive amount of fluid. Finally, by employing a translucent or transparent splashback shield, the view of a wound site by the medical practitioner will be unobstructed during the wound irrigation process.
1o While this invention is directed primarily to the field of wound irrigation, the connector can be used to transfer any type of fluid from a flexible container to the end from which the fluid is applied. For example, the connector can be used to transfer a topical medication from a flexible container to the surface of the skin.

F1G. 1A is a perspective view of one embodiment of the assembly of this invention.
FIG. 1 B is a side view in elevation of one embodiment of the assembly of this invention, showing a hood for covering the spike.
FIG. 2 is an exploded perspective view of the embodiment shown in FIGS. 1A
and 1 B.
FIG. 3 is a side view in elevation of a cross section of the embodiment shown in FIGS. 1A and 1 B.
3o FIG. 4 is a bottom plan view of the splashback shield shown in FIGS. 1A and 1 B.

FIG. 5 is a top plan view of the splashback shield shown in FIGS. 1A and 1 B.
FIG. 6 is a side view in elevation of a cross section of the embodiment shown in FIGS. 1A and 1 B, further showing one end of the assembly connected to a flexible container and the splashback shield of the assembly in contact with the skin.
FIG. 7A is a top plan view of a splashback shield of another embodiment of the assembly of this invention.
FIG. 7B is a front view in elevation of the embodiment shown in FIG. 7A.
FIG. 7C is a side view in elevation of a cross section taken along line C-C of the embodiment shown in FIG. 7A
FIG. 7D is a rear view in elevation of the embodiment shown in FIG. 7A.

DETAILED DESCRIPTION
As used herein, the term "diameter" means a straight line segment passing through the center of a figure, such as, for example, a circle, and terminating at the periphery. In this invention, inlets, outlets, and bores of various components that are described as being circular are substantially circular in shape; however, on account of the difficulty encountered in forming inlets, outlets, and bores that are perfectly circular in shape, the inlets, outlets, and bores may not be perfectly circular in shape, in which case, the term "diameter" refers to a.measured value that approximates the diameter of a circle. The expression "flexible container" means any container that is capable of being bent or flexed. The expression "flexible container" is also intended to include semirigid containers, i. e., containers that are partially rigid, that is, having some rigid components. In other words, the wall or walls of a "flexible container" can be bent or have their shape changed without undergoing breakage. Representative examples of ~5 flexible containers suitable for use with the connector of this invention include, but are not limited to, flexible bags containing intravenous fluids, flexible bags containing irrigation fluids, semirigid bottles containing intravenous fluids, and semirigid bottles containing irrigation fluids. Examples of flexible containers suitable for use in this invention are described in U. S. Patent Nos. 5,492,531; 5,795,324, and 5,931,820, all of which are incorporated herein by reference. The term "fluid" means liquid, such as, for example, water, aqueous-based liquids. Representative examples of fluids suitable for use with the connector of this invention include, but are not limited to, sterile water, injectable saline solutions, and saline solutions for irrigation.
Referring now to FIGS. 1A, 1 B, 2, 3, and 6, an assembly 10 suitable for irrigating a wound site comprises a connector 12 having an end 14 that is capable of being joined to a flexible container and a nozzle end 16. A valve 18 is located between the end 14 and the end 16 of the connector 12. Attached to the end 16 of the connector 12 is a splashback shield 20. The connector 12 has a wall 12a that encloses a bore 12b.
3o In the embodiment shown iri FIGS. 1A, 1 B, 2, 3, and 6, the connector 12 is actually a composite of two components that are joined together by means of welding or some other means of adhesion. The first component of the connector 12 comprises a component 22 that is capable of being joined to a flexible container, and the second component of the connector 12 is a component 24 that contains a nozzle.
However, it is possible to make the connector 12 a unitary component and join that unitary s component to the splashback shield 20. It is even possible to make the entire splashback shield 20 and connector assembly 10 out of one component so long as the valve 18 is inserted in the proper position therein.
The connector 12, i. e., the components thereof, is preferably made of plastic, more preferably injection molded plastic, but may be made of other materials suitable 1o for the purpose intended. The linear dimensions of the various portions of the components of the connector 12 can vary, and the linear dimensions of the various portions of the components of the connector 12 are not critical to the operation of the invention. However, in order to simplify discussion of the assembly 10, suitable dimensions for a preferred embodiment will be described. The length of the portion ~5 12c of the connector 12 that extends from the tip 14a of the end 14 to the shoulder 12d is preferably about 1.06 inches. The outside diameter of the portion 12c of the connector 12 is preferably about 0.220 inch. The inside diameter of the bore 12b of the portion 12c of the connector 12 is preferably about 0.130 inch. The portion 12c is preferably tapered. A tapered construction is not critical to the operation of the 2o connector assembly 12, but the tapered shape facilitates the removal of the component 12c from the mold used to form it. In the preferred embodiment, the end 14 is characterized as having a bevel angle a, which angle is preferably approximately 25°. The purpose of the bevel angle a is to form a spike at the tip 14a of the end 14.
The purpose of the spike 14 is to allow the medical practitioner to puncture a seal that 25 covers the mouth of a flexible container so that the connector 12 will have access to the fluid in the container. The end 14 need not have a spike if the connector 12 can have access to the fluid in the container by other means, such as, for example, a Luer fitting or a threaded fitting. In the emergency room or trauma center environment, a spike is preferred for considerations of speed and convenience. When the tip 14a has 3o a spiked configuration, the tip 14a preferably has a plurality of facets (not shown) so that the seal that covers the mouth of a flexible container can be pierced with a minimal amount of insertion force. The inside diameter of the bore 12b of the portion 12e of the connector 12 extending from the nozzle end 16 to the point where the portion 12e contacts the flange 12f of the connector 12 is preferably about 0.350 inch.
The outside diameter of the portion 12e of the connector 12 is preferably about 0.440 inch. The length of the portion 12e of the connector 12 is preferably about 0.600 inch.
The length of the portion 12g extending from the shoulder 12d to the point where the portion 12g contacts the flange 12f of the connector 12 is preferably about 0.270 inch.
The inside diameter of the bore 12b of the portion 12g of the connector 12 is preferably about 0.177 inch. The outside diameter of the portion 12g of the connector 12 is preferably about 0.268 inch. The outside diameter of the flange 12f is preferably about 0.513 inch. The inside diameter of the bore 12b of the flange 12f is preferably about 0.453 inch. The length of the flange 12f is preferably about 0.122 inch.
In the preferred embodiment, the valve 18 is of the type that is actuated by pressure, the pressure being supplied by the user's compressing the flexible container containing the fluid, which container is attached to the connector 12 during use. As shown in FIGS. 2, 3, and 6, the valve 18 comprises a reseal ball 26 that is biased to the closed position by a resiliently biasing element 28, such as, for example, a helically coiled spring. When the valve 18 is closed, the reseal ball 26 is restrained by the portion 12h of the wall 12b that surrounds the passageway between the portion 12e 2o and the portion 12g of the connector 12. Other types of valves can be used, such as, for example, a duckbill valve, a sleeve valve, a flex valve, a diaphragm valve. It is even contemplated that valves actuated by means other than pressure can be used.
Such alternate valves include valves that are actuated by rotational movement, such as, for example, a stopcock, a spool valve. The reseal ball 26 is preferably made of 25 latex free elastomeric material. However, the material of the reseal ball 26 is not critical, and other materials, such as, for example, plastic, can be used. The spring 28 is preferably made of stainless steel. However, the material of the spring 28 is not critical, and other materials, such as, for example, plastic, can be used. A
pressure of at least about 0.5 psig is typically required to overcome the resistance of the spring 28 3o and unseat the reseal ball 26 from its closed position. The diameter of the spring 28 should be less than the inside diameter of the portion 12e of the connector 12 that houses the spring 28, so that fluid can flow between the inside wall of that portion 12e of the connector 12 and the spring 28. The diameter of the spring 28 is preferably about 0.25 inch and the uncompressed length of the spring 28 is preferably about 0.435 -inch. The diameter of the reseal ball 26 must be of sufficient size to block the passageway between the portion 12e of the connector 12 and the portion 12g of the connector 12 when the valve 18 is in the closed position or when the assembly 10 is not in use. The diameter of the reseal ball 26 is preferably about 0.315 inch.
At the nozzle end 16 of the connector 12 are located a nozzle 30 and a plurality of channels 32 extending radially from the inlet 30a of the nozzle 30. The purpose of 1o the channels 32 is to allow the fluid from the flexible container to flow to the inlet 30a of the nozzle 30. Ribs 32a separate channels 32 that are adjacent. If the spring 28 is compressed to its solid height (i. e., compressed as much as possible), the fluid from the flexible container will flow in the space between the spring 28 and the wall of the portion 12e of the connector 12 to the channels 32. The channels 32 also function to ~5 reduce resistance to the flow of the fluid. The width of the channels 32, at the point where the channels are adjacent to the nozzle 30, is preferably about 0.08 inch and the depth of the channels 32 is preferably about 0.03 inch. As shown in FIG.
5, the number of channels 32 is eight. However, the number of channels 32 can be greater or lesser than eight. The length of the nozzle 30 is preferably about 0.1 inch. The tip 20 30b of the nozzle preferably extends below the uppermost portion of the splashback shield 20. The nozzle 30 is preferably tapered. A typical angle of taper from the inlet 30a of the nozzle 30 to the tip 30b of the nozzle 30 is about 15°. The inside diameter of the nozzle 30 at the inlet 30a thereof is preferably about 0.070 inch. The inside diameter of the nozzle 30 at the tip 30b thereof is preferably about 0.045 inch. The 25 outside diameter of the nozzle 30 is not critical to the operability of the assembly 10.
However, it is preferably tapered to facilitate the removal of the splashback shield 20 from the mold used to form it.
As shown in FIGS. 3, 4, 5, and 6, the splashback shield 20 comprises a wall 34 enclosing a substantially hemispherical volume 36. The wall 34 is preferably made of so a translucent or transparent polymeric material. Suitable polymeric materials for forming the splashback shield include, but are not limited to, acrylic polymers and polycarbonates. It is preferred that the material of the wall 34 be translucent or transparent so that the medical practitioner can observe the condition of the wound during the irrigation procedure. The portion 34a of the wall 34 where the connector 12 joins the splashback shield 20 is shown as being planar rather than curved, but this portion need not be planar. The splashback shield 20 has a rim 38. The rim 38 is the portion of the splashback shield 20 that contacts the skin of the patient during the wound irrigation procedure. The rim 38 of the splashback shield 20 is shown to have a plurality of passageways 40, but the rim 38 need not have such passageways 40.
It is preferred that the rim 38 have at least one passageway 40, preferably a plurality of passageways 40, in order to allow escape of fluid from the enclosed volume 36, without the necessity of lifting the assembly 10. It has been discovered that the use of at least one passageway 40 improves the performance of the wound irrigation process, by preventing the splashback shield 20 from being sealed to the skin of the patient. In FIGS. 1A, 1 B, 2, 3, and 6, the passageways 40 are sinusoidal in shape.
However, the ~5 passageways 40 may have different shapes including, but not limited to, rectangles, triangles, semicircles, and semiellipses.
The volume 36 enclosed by the wall 34 of the splashback shield 20 need not be hemispherical or substantially hemispherical. However, it is preferred that volume 36 enclosed by the wall 34 of the splashback shield 20 have the shape of a regular 2o geometric structure. While it is impossible to list all of the regular geometric structures that can be enclosed by the splashback shield 20, some of the preferred regular geometric structures include, but are not limited to, conical, frusto-conical, cylindrical, paraboloidal, cubic, and pyramidal structures.
The assembly 10 shown in FIGS. 1A, 1 B, 2, 3, and 6 can be constructed in 25 numerous ways. A preferred method of making the assembly 10 will now be described. The components required to assemble the embodiment shown in FIGS.
1A, 1 B, 2, 3, and 6 include the splashback shield 20, the spring 28, the reseal ball 26, and the component 22, which includes the portions 12c, 12d, 12f, 12g, 14, and 14a of the connector 12. The splashback shield 20 and the component 22 can be prepared so by a process of injection molding. Processes of injection molding are described in, for example, Encyclopedia of Polymer Science and Engineering Volume 8, John Wiley &

Sons, Inc. (New York:1987), pp. 102-138, incorporated herein by reference. The reseal ball 26 and the spring 28 are commercially available and methods for manufacturing them are well known to those skilled in the art. In this embodiment, the portion 12e of the connector 12 is unitary with the splashback shield 20.
Referring now to FIG. 2, the assembly 10 can be prepared by inserting the spring 28 into the portion 12e of the connector 12, whereby the spring 28 rests on the ribs 32a that separate the channels 32 of the splashback shield 20. Then the reseal ball 26 is placed at the end 28a of the spring 28. Then the component 22 is placed over the rim 12i of the portion 12e of the connector 12. Then, ultrasonic energy is applied to the interface of the rim 12i of the portion 12e of the connector 12 and the flange 12f in the vicinity of an energy director 12j located on a surface of the flange 12f (see FIG. 3). The ultrasonic energy fuses the end 14 to the rim 12i of the portion 12e of the connector 12.
Instead of ultrasonic welding, the rim 12i of the portion 12e of the connector 12 can be joined to the flange 12f of component 22 by means of adhesive bonding, solvent bonding, snap fitting, or the like. A hood 42 can be employed to cover the end 14 of the assembly 10 in order to protect the medical practitioner and the flexible container from being punctured. The hood 42 is an elongated, tapered tube, closed at one end 42a and open at the other end 42b. The end 14 of the assembly 10 is inserted into the open end 42b of the hood 42 and guided therein until stopped by the flange 12f of the 2o connector 12. The hood 42 is preferably made of a polymeric material, such as, for example, polyethylene.
An alternative embodiment of the assembly of this invention is shown in FIGS.
7A, 7B, 7C, and 7D. This embodiment allows the medical practitioner to orient the flexible container in a different position relative to the splashback shield for dispensing fluid. The flexible container and the segments of the connector extending from (a) the end capable of being joined to the flexible container and running to (b) the valve are not shown in FIGS. 7A, 7B, 7C, and 7D, because these components do not differ significantly from like components shown in the embodiment of FIGS. 1A, 1 B, 2, 3, and 6. In this embodiment, the nozzle 50 has a tip 52 that is flush with one end 54 of a 3o splashback shield 56. The nozzle 50 and tip 52 thereof is elongated to allow the fluid to flow in a broad stream (see FIG. 7B). As in the embodiment shown in FIGS.
1A, 1 B, 2, 3, and 6, the assembly has a plurality of passageways 40 in order to allow escape of fluid from the enclosed volume 58, without the necessity of lifting the splashback shield 56 from the skin of the patient. In addition, the splashback shield 56 contains at least one, and preferably a plurality of, fluid deflectors to direct the fluid stream to the wound site. The fluid deflectors 60a and 60b at equal distances from the tip 52 of the nozzle 50 preferably have a gap 62 between them to allow the fluid to project to a greater distance from the nozzle 50. Likewise, the fluid deflectors 64a and 64b preferably have a gap 66 between them to allow the fluid to project to a greater distance from the nozzle 50. The fluid deflector 68 is shown as not having a gap. In other respects, the 1o components of FIGS. 7A, 7B, 7C, and 7D are substantially similar to those components described for the first embodiment, except that the splashback shield 56 has a shape that differs from the shape of the splashback shield 20.
OPERATION
In order to use the assembly 10 of this invention to clean a wound, the hood is first removed from the end 14 of the assembly 10. Then the tip 14a of the end 14 is inserted into the seal covering the mouth of a flexible container "C" of fluid, e. g., sterilized irrigation fluid. The seal is not shown. At this point, the fluid does not flow out of the nozzle 30 because no pressure is being applied to the flexible container "C"
and the spring 28 has sufficient potential energy to counteract the pressure thereon provided by the gravity of the fluid. The combination of the container "C" and the assembly 10 is then transported to the wound site "S". There, the splashback shield 20 is placed over the wound site "S" so that the center of the splashback shield 20 is approximately over the center of the wound. The medical practitioner applies pressure to the flexible container "C" by squeezing the container with one hand or two, whichever is preferable to the medical practitioner. When sufficient pressure is applied to the container "C", the force of the fluid overcomes the force exerted by the valve 18, thereby causing the valve 18 to open, whereby the fluid is allowed to emerge from the 3o nozzle 30. The emerging fluid cleanses the wound. The passageways 40 allow spent irrigation fluid, blood, debris, and the like to be flushed out of the enclosed volume 36 of the splashback shield 20 so that fresh fluid can take the place of the spent fluid without having to move the assembly 10 from its position over the wound.
This invention provides several advantages over wound irrigation devices known in the art. First, the valve mechanism allows the medical practitioner to restrain the flow of fluid until the assembly is in place over the wound. Second, the passageways in the splashback shield allow the medical practitioner to remove spent irrigation fluid without removing the assembly from the vicinity of the wound.
Third, the assembly eliminates the need for a syringe to propel the irrigation fluid under pressure to the wound. Fourth, the assembly allows the medical practitioner to irrigate the 1o wound without pausing to refill a syringe. Fifth, the valve allows the medical practitioner to position the assembly without wasting an excessive amount of fluid.
Finally, by employing a translucent or transparent splashback shield, the view of a wound site by the medical practitioner will be unobstructed during the wound irrigation process.
Various modifications and alterations of this invention will become apparent to those skilled in the art without departing from the scope and spirit of this invention, and it should be understood that this invention is not to be unduly limited to the illustrative embodiments set forth herein.

Claims

What is claimed is:

1. A connector suitable for use in transferring fluid from a flexible container, said connector comprising an end capable of being joined to an outlet of a flexible container containing a fluid, an end containing a nozzle, and a valve for regulating the flow of said fluid from said flexible container to said nozzle.

2. The connector of claim 1, wherein said end capable of being joined to an outlet for a flexible container of fluid is a spiked end.

3. The connector of claim 1, wherein said fluid is sterile fluid.

4. The connector of claim 1, wherein said valve is capable of being actuated by pressure.

5. The connector of claim 1, wherein said valve is a ball valve.

6. The connector of claim 1, wherein said valve is a duckbill valve.

7. The connector of claim 1, wherein said valve is a spool valve.

8. The connector of claim 1, wherein said valve is a sleeve valve.

9. The connector of claim 1, wherein said valve is capable of being actuated by rotation.

10. The connector of claim 1, wherein said valve is a stopcock valve.

11. An assembly for use in wound irrigation comprising the connector of claim 1 and a splashback shield located adjacent to said end containing said nozzle.

12. The assembly of claim 11, wherein said splashback shield comprises a wall that encloses a volume.

13. The assembly of claim 12, wherein said wall has a rim that contacts the skin of a patient.

14. The assembly of claim 13, wherein said rim is formed so that there is at least one passageway between said wall and said skin of said patient when said splashback shield is placed in contact with said skin of said patient.

15. The assembly of claim 14, wherein said at least one passageway is sinusoidal in shape.

16. The assembly of claim 14, wherein said at least one passageway is rectangular in shape.

17. The assembly of claim 14, wherein said at least one passageway is triangular in shape.

18. The assembly of claim 14, wherein said at least one passageway is semicircular in shape.

19. The assembly of claim 12, wherein said volume has a shape of at least a portion of a regular geometric figure.

20. The assembly of claim 19, wherein said regular geometric figure is a sphere.

21. The assembly of claim 19, wherein said regular geometric figure is a pyramid.

22. The assembly of claim 19, wherein said regular geometric figure is a cone.

23. The assembly of claim 12, wherein said wall of said splashback shield is translucent.

24. The assembly of claim 12, wherein said wall of said splashback shield is transparent.

25. The assembly of claim 11, wherein at least one channel is located adjacent to said valve in order to allow fluid to flow into said nozzle.

26. The assembly of claim 11, wherein said valve comprises a reseal ball and a spring.

27. A method for irrigating a wound site comprising the steps of:
(a) providing a flexible container containing a wound irrigation fluid;
(b) providing an assembly for use in wound irrigation comprising the connector of claim 1 and a splashback shield located adjacent to said end containing said nozzle;
(c) connecting said assembly to said flexible container;
(d) positioning said assembly so that said splashback shield covers said wound site;
(e) applying a sufficient amount of pressure to said flexible container so that said valve opens and said wound irrigation fluid flushes said wound site.

28. The method of claim 27, wherein said connector has a spiked end.

29. The method of claim 27, wherein said pressure applied is at least about 0.5 psig.

30. A method for transferring fluid from a flexible container comprising the steps of:
(a) providing a flexible container containing a fluid;
(b) providing an assembly comprising the connector of claim 1;
(c) connecting said assembly to said flexible container;
(d) applying a sufficient amount of pressure to said flexible container so that said valve opens and said fluid emerges from said nozzle.

31. The method of claim 30, wherein said connector has a spiked end.

32. The method of claim 30, wherein said pressure applied is at least about 0.5 psig.