Wound irrigation device

Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...

Reexamination Certificate

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Details

C604S039000, C604S268000

Reexamination Certificate

active

06558344

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to the field of medical instruments and more particularly to a medical device to prevent splashing of possibly infectious patient bodily fluids and tissues onto medical personnel during wound irrigation.
BACKGROUND OF THE INVENTION
In the medical field, the treatment of lacerations frequently requires that the wound be cleansed prior to closure. This cleansing ensures the removal of any foreign matter such as glass, grass, gravel, dirt, metal particles and/or bacteria. Any and all of these contaminants foster infection if not properly removed from the wound. The cleansing process also removes blood from the wound such that the treating medical personnel may properly explore the wound to verify and complete necessary treatment prior to the closing of the wound.
The above cleansing of a wound is commonly performed by irrigation of the wound using a syringe and a hypodermic needle, or an intravenous catheter with a blunted stylet and where the catheter length has been cut. Typically, the catheter is of 18 gauge size. Typically, the syringe is filled with an irrigating fluid, the needle is directed toward the wound, and the plunger of the syringe is depressed. The irrigation stream from the syringe and catheter combination acts to mechanically dislodge any contaminants from the wound. One obvious drawback of this process is that inherent force of the irrigation stream necessary to cleanse the wound also creates splashing and misting of the irrigation fluid and the contaminated bodily fluid. This splashing increases the risk of infection from the patient to the medical personnel providing treatment.
One known syringe splash shield provides a circular cup with integral tap on the exterior portion for connecting to a standard syringe and integral threads on the interior for attachment of a standard needle hub. The size of the circular cup is such that the needle extends beyond the base plane of the cup. Thus, this design has the inherent disadvantage of being capable of only deflecting high-angle splashes from the wound area. Additionally, the use of a needle that extends beyond the base plane of a cup increases the possibility of stabbing the patient with the needle.
Another known syringe splash shield incorporates a bell-shaped housing for deflecting splashed fluids for use with a syringe but not a needle. While this design avoids the drawback of the aforementioned syringe splash shield with a needle, it too has disadvantages. The open, planar surface of the bell-shaped housing is such that if it is held above the surface of the skin, the housing only contains high-angle splash. As such, this design may fail to fully meet its objective. On the other hand, if the bell-shaped housing is used while contacting the patient, the contained fluid cannot escape and may linger in the wound area and frustrate the intended debridement.
Both of the above known syringe splash shields are defined by circular openings. While this shape may be more easily manufactured, they are less conducive to use on long, narrow portions of the body where lacerations often occur, i.e., forearms, biceps, or calves.
In view of these perceived deficiencies in known syringe splash shields, it would be beneficial to provide a splash shield that enables medical personnel to properly clean a wound while containing essentially all splashed irrigating fluid and contaminants. It would also be beneficial to provide a splash shield that allows the contained fluid to escape in a controlled manner. It would be additionally beneficial to provide a splash guard in a shape that would function ideally on all parts of the patient's anatomy where a laceration may occur.
SUMMARY OF THE INVENTION
In accordance with the present invention, a wound irrigation splash shield is disclosed. The wound irrigation splash shield allows medical personnel to properly cleanse a wound while confining the irrigating fluid within the shield. The wound irrigation splash shield of the present invention is intended to be used in contact with a patient's skin in the area surrounding the wound to prevent essentially all splashing of the irrigating fluid and other contaminants onto other parts of the patient's body or the attending medical personnel.
The wound irrigation splash shield of the present invention is essentially an inverted shell having an open bottom bordered by a rim or bottom edge. The top portion of the shell contains an orifice that allows for the irrigating fluid to pass into the center of the shell. The orifice can be positioned along the shell surface to optimize the direction of the irrigating fluid stream toward the wound. The top portion of the shell may take the shape of a truncated shell such that the top portion of the shell is substantially flat. The orifice may be positioned on this flat portion at the top of the shell. Further, the orifice may be centrally located within this flat portion.
The orifice of the splash shield may be designed to accommodate a syringe such that the syringe fits naturally into a receiver adjacent to the orifice. The receiver and/or the syringe may be designed in such a way that the syringe may be fixedly inserted into the receiver and yet remain removable by exerting a small amount of force. In this way, the syringe may be held to the splash shield without external force and yet be easily removed to re-fill the syringe with irrigating fluid as necessary. In fact, the splash shield of the present invention may be packaged, sold, stored, and/or used with the syringe as a set.
The orifice of the splash shield may also accommodate a luer tip of a bottle filled with saline solution or other irrigating fluid. The bottle may include a cap which may be removed from the bottle, e.g., by twisting or snapping. The removal of the cap may expose the luer tip. The luer tip has a similar geometry to the syringe tip. In this way, the luer tip of the bottle may be inserted directly into the orifice of the splash shield. The bottle may have collapsible sides, for example, bellows, such that attending personnel need only to squeeze the bottle to expel the irrigating fluid from the bottle through the luer tip.
The splash shield of the present invention may be shaped so as to be more readily used on long, narrow portions of the patient's body. For example, the shell may be substantially oval-shaped having a lateral dimension and a longitudinal dimension wherein the longitudinal dimension is greater than the lateral dimension. In one embodiment, the longitudinal dimension is at least 1.2 greater than the lateral dimension. The shape of the splash shield of the present invention may also be defined, at least in part, by the height of the splash shield relative to the longitudinal and/or lateral dimensions of the splash shield. In one embodiment of the present invention, the lateral width of the splash shield may be 1.5 times larger than the height of the splash shield. In another embodiment, the lateral width dimension could be about 2 times larger than height of the splash shield.
The bottom of the splash shield is formed with one or more outlet areas through which the combination of irrigating fluid and body fluids and/or tissues can escape for subsequent capture. In one embodiment, the outlet areas are defined using contoured portions. More specifically, the rim of the splash shield may include substantially flat portions and the contoured portions. The flat portions may be planar. The contoured portions can define channels or outlet area portions which allow the expended irrigating fluid to pass from the interior of the shell to the exterior of the shell. The irrigating fluid passing to the exterior of the shell may then be collected in various ways. For example, the fluid may be allowed to flow naturally to a pan or wound basin placed under the patient's body part or may be collected using a suction device. The contoured portions and the associated channels may be further defined in size relative to other dimensions of the splash shield. For exampl

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