Abstract:
The present invention is directed to a wound splashguard which includes a wound cover for blocking fluid splatter, and an adjustable fluid source mount for allowing movement of a fluid source from a first position to at least a second position to re-direct a fluid spray relative to the wound while the splash guard is maintained in a substantially stationary position. The invention is further directed to a method of using the adjustable mount which allows the practitioner to move the fluid source so that the fluid spray can irrigate a larger portion of a wound without having to move the splashguard thereby increasing irrigation efficiency and reducing the risks of needle stick injury.

Description:
FIELD OF THE INVENTION  
         [0001]    This invention relates to a medical device used during medical procedures such as wound cleansing and irrigation. In particular, the invention relates to a handheld wound splashguard which prevents the patient&#39;s body fluids from contaminating medical personnel during these procedures.  
         BACKGROUND OF THE INVENTION  
         [0002]    Wounds such as lacerations, abrasions, puncture wounds, and deep cuts are often contaminated with particulate debris, including dirt or grass, as well as fragments of glass, metal or rock. These contaminates may harbor high levels of bacteria and other harmful microorganisms, and to prevent sepsis and infection, these wounds should be cleansed of the debris as a step in the treatment regime for the wound.  
           [0003]    In an clinic or emergency room setting, cleansing a patient&#39;s wounds is often accomplished by washing the wounds with a sterile/antiseptic irrigation fluid. The most common method of washing these wounds is to use a syringe containing the fluid or mechanical pump with a fluid reservoir attached to a hypodermic needle. Sufficient fluid is then injected through the needle and passed over the wound&#39;s surface to wash away the debris. Depending on the size of the wound and the amount of contamination in the wound, the amount of irrigation fluid used during wound irrigation can vary from about less than one hundred milliliters to several liters.  
           [0004]    The method can involve inserting a hypodermic syringe needle into the wound cavity, and using the syringe to force irrigation fluid across the wound&#39;s surface, thereby forcing out the debris or contaminated material. In addition, some large wounds, particularly abrasions, can require additional irrigation along multiple sites across the length of the wound. Additional irrigation can be accomplished by refilling/replacing the syringe and reusing the needle, or by replacing of both the syringe and needle.  
           [0005]    This irrigation procedure is not without its risks. First, upon contact with the wound, the irrigation fluid becomes contaminated with the patients blood and lymph. This contaminated fluid can then be splattered from the wound and onto adjacent medical personnel. The fluid can travel a significant distance from the wound, and depending in part on the pressure being used to irrigate the wound, the fluid can contaminate medical personnel. When the patient has a concurrent infectious disease, such as hepatitis C, hepatitis B or AIDS, this contaminated fluid can be of particular concern to the medical personnel.  
           [0006]    Also, the hypodermic needle used during the irrigation can also become contaminated by the patient&#39;s blood. When more than one syringe full of fluid is necessary to cleanse the wound, or if the syringe needs to be moved to a different site along the wound&#39;s surface, the removal and replacement of the needle represents a needle stick hazard. Since the needle is contaminated with the patient&#39;s blood, a needle stick is potentially a greater risk to medical personnel in terms of infectious disease transmission. In addition, the contaminated needles are typically disposed of in SHARPS containers. SHARPS containers are medical waste containers specifically designed for the disposal of this type of medical waste. Once the containers are filled, they are specially sealed and removed from the hospital. However, the removal and disposal of these containers is both hazardous and relatively expensive. Thus, there is a need during wound irrigation to reduce the chance of needle stick injuries and the number of contaminated hypodermic needles produced during medical procedures.  
           [0007]    At present, medical personnel are taking several measures to reduce the aforementioned risks of transmission of disease from patient to physician. These measures include the use of protective face shields and the use of hand-held wound guards. Face shields are clear plastic barriers attached to head pieces, and are worn by practitioners to prevent backsplash contamination. Although a face shield prevents contaminated fluid from reaching the practitioners face, the shields are cumbersome in use, can be slightly off-putting to patients, and offer no protection to the rest of the practitioners body or adjacent personnel. Nor do the shields address the aforementioned needle stick problems associated with the wound irrigation.  
           [0008]    Prior wound guards provide a barrier between medical personnel and the contaminated fluid. However, the currently available wound guards are less efficient to use than is desirable. To use such wound guards, the practitioner typically must hold the wound guard with one hand while inserting the needle of the irrigation syringe through an aperture or mount in the guard, or through the guard itself. When the syringe is empty, it must be removed, refilled and replaced. Replacing the syringe typically requires the practitioner to reinsert the syringe through the wound guard which brings the hypodermic needle into close proximity to the practitioner&#39;s hand holding the wound guard. This proximity creates an additional risk of a needle stick injury for the practitioner. Frequently, particularly when treating large or elongated wounds, the practitioner must move the syringe to repeatedly irrigate a different portion of the wound. In such cases, the practitioner either leaves the syringe in the wound guard, and moves both guard and syringe at once, or the physician removes the syringe from the guard, moves the guard, and replaces the syringe. Moving both the syringe and guard at once requires the practitioner to use both hands, which can be relatively cumbersome and inefficient in some instances and may involve additional risk of needle stick injury. Removing and replacing the syringe, while less cumbersome, can create a higher risk of needle stick injury.  
           [0009]    Finally, the production and storage costs associated with typical disposable wound guards can be higher than is desired. Typical guards incorporate multiple parts, which increases production costs. Also, some guards cannot be easily stacked for efficient shipping and storage. Therefore, a need exists for a wound splash guard that can irrigate a larger portion of a wound or abrasion without being moved. There is also a need for a wound splash guard that can retain a hypodermic needle and thereby minimize needle stick injury due to the necessity of repeatedly inserting the syringe into the guard. There is also a need for a wound guard that can be economically manufactured and efficiently shipped and stored.  
         SUMMARY OF THE INVENTION  
         [0010]    The present invention is directed to a wound splashguard which includes a wound cover for blocking fluid splatter, and an adjustable fluid source mount for allowing movement of the fluid source from a first position to other positions to redirect the fluid spray relative to the wound while the splash guard is maintained in a substantially stationary position. The adjustable mount allows the practitioner to move the fluid source so that the fluid spray can irrigate a larger portion of a wound without having to move the splashguard, thereby increasing efficiency and reducing the risks of needle stick injury. Preferably, the mount of the wound guard includes a cup member which snugly retains a fluid source of a predetermined dimension. Use of such a cup member can ease the movement of the splashguard from position to position and further reduce the risk of needle stick injuries when a syringe is used as a fluid source.  
           [0011]    In one embodiment of the invention, the wound cover forms a dome for covering the wound, and the adjustable fluid source mount is located on the surface of the wound cover. The adjustable fluid source mount preferably includes a corrugated tube for moving the fluid source from a first position to at least a second position and thereby re-directing the fluid spray around the wound. The preferred fluid source mount includes a cup member which is dimensioned to receive and retain by friction fit the needle support portion or base of a syringe. The cup defining at least a portion of the passageway extending through the wound cover for receiving a needle attached to the syringe. In this preferred embodiment, the wound cover and adjustable fluid source mount are integrally formed from a generally transparent plastic material and include a conical section. The wound cover also includes at least one drainage aperture to channel the flow of blood and irrigation fluid away from the wound site.  
           [0012]    In another embodiment of the invention, the splashguard includes a wound cover and an adjustable fluid source mount having a ball-in-socket arrangement. Preferably, the socket is integrally formed in the wound cover and the ball member is rotatably mounted in the socket. The ball member includes a cup member having a cup aperture for retaining the fluid source and a passageway communicating with the interior of the splashguard. Other alternative embodiments of the invention are contemplated in which the adjustable fluid source mount may include a pivot member and hinge, a sliding member in slot arrangement or flexible tube. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0013]    [0013]FIG. 1 depicts a perspective view of one embodiment of the wound splashguard of the invention shown with a syringe and needle inserted into the splashguard.  
         [0014]    [0014]FIG. 2 depicts a side view of the splashguard of FIG. 1.  
         [0015]    [0015]FIG. 3 depicts a plan view of the splashguard of FIG. 1.  
         [0016]    [0016]FIG. 4 depicts an end view of the splashguard of FIG. 1 illustrating the bending of the adjustable fluid source mount in phantom.  
         [0017]    [0017]FIG. 5 is an enlarged cross-sectional view taken along lines  5 — 5  of FIG. 2.  
         [0018]    [0018]FIG. 6 is an alternate embodiment of the splashguard invention in cross-section.  
         [0019]    [0019]FIG. 7 is a perspective view of another alternate embodiment of the splashguard of the invention.  
         [0020]    [0020]FIG. 8 is a fragmentary plan view of the splashguard.  
         [0021]    [0021]FIG. 9 is a cross-sectional view taken along lines  9 — 9  of FIG. 8.  
         [0022]    [0022]FIG. 10 is a cross-sectional view taken along lines  10 — 10  of FIG. 9. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]    The present invention relates to a wound splashguard for use during wound irrigation procedures. FIGS.  1 - 5  generally depict a wound splashguard  20  in accordance with one embodiment of the invention. The splashguard  20  generally includes a wound cover  30  and an adjustable fluid source mount  40  (hereinafter “the mount  40 ”), which includes a corrugated tube  42  and cup member  43 . As can be best seen in FIG. 1, the mount  40  is preferably integrally formed with the wound cover  30 . It is contemplated that the splashguard  20  may be fashioned from more than one piece. For example, the adjustable mount could be adhered to or snap fit onto the wound cover.  
         [0024]    The wound splashguard  20  is preferably made from a generally transparent, plastic resin so that the wound and hypodermic needle can be clearly visualized through the wound cover  30 . The splashguard of the invention be made from a variety of plastic resins commonly used in disposable surgical devices by conventional injection molding or blow molding techniques. For example, the wound cover can be formed from transparent materials such as polyvinyl chloride or polypropylene injected into a suitable mold. Although in the embodiment depicted in FIGS.  1 - 5  it is preferred that the splashguard be semi-rigid and hemispherical in shape, it is further contemplated that the splashguard of the invention may range from flexible to substantially rigid, and from substantially transparent to slightly opaque, depending on the materials selected for the splashguard&#39;s manufacture.  
         [0025]    For the purpose of this description, the exterior surface of the splashguard  20  is defined as the surface which faces the practitioner during the application and use of the wound cover, and the interior surface of the splashguard  20  is defined as the surface of the wound cover which faces the patient. The space between the interior surface of the splashguard and the patient is defined as the “interior shield space.” 
         [0026]    The splashguard  20  of FIG. 1 and FIG. 2, includes a wound cover  30  for blocking the splatter or backsplash of irrigation fluid which has a generally oval shaped base  32  (FIG. 2), from which extends a generally transparent dome  36 . The generally oval shaped base  32  and dome  36  depicted are configured to provide greater coverage for elongated laceration wounds and cuts. It is contemplated that the wound cover may be configured with different shapes, as long as the shapes provide a barrier to prevent splatter and can be readily held by the practitioner. For example, but without limitation, a generally round base and hemispherical dome may also be employed to provide a more efficient barrier for irrigating deep puncture wounds, or a generally polygonal base and rounded box shaped dome may be employed for general wound irrigation.  
         [0027]    As best seen in FIG. 1, the base  32  has two raised areas located along the elongated axis of the perimeter which define a pair of drainage apertures  31 ,  33  (FIG. 2). These drainage apertures are shaped to channel irrigation fluid and blood to flow away from the wound, but are sized to prevent or reduce the amount of fluid splatter through these apertures  31 ,  33 . Also, a rim  35  of thickened transparent plastic for improving the dome&#39;s rigidity is located at the periphery of the base  32  of the generally transparent dome  36 .  
         [0028]    As seen best in FIG. 1, wound cover  30  has a generally frusto-conical portion  38  located at the approximate apex of the generally transparent dome  36 . As depicted in this embodiment, this frusto-conical portion  38  is integrally formed with the transparent dome  36  of the wound cover  30 . The frusto-conical portion  38  raises mount  40  above the exterior surface of the transparent dome  36 , and encompasses a corresponding frusto-conical, interior space defined by the interior surface of the frusto-conical portion  38  of the dome  36 . When several wound splashguards are stacked on top of each other for storage or packaging, the fluid source mount  40  fits within the conical space, enabling the wound splashguards  20  to be more efficiently stacked. As can be seen in FIG. 5, the wound cover  30  has an aperture  37  which passes through the wound cover to receive at least a portion of the fluid source so that at least a portion of the fluid source projects into the interior shield space to provide fluid spray to the wound.  
         [0029]    In the embodiment shown in FIGS.  1 - 5 , the mount  40  is located on top of the conical section  38  and includes the corrugated plastic tube  42  and the cup member  43 . The corrugated plastic tube is formed by alternating ridges and grooves of plastic material. The corrugated tube  42  is flexible so that the tube  42  can be bent by the practitioner to change the position of the fluid source to direct the fluid spray to different sections of the wound without substantial movement of the wound cover  30 . Bending the corrugated tube  42  causes the ridges and grooves on the surface on the interior angle to collapse and the ridges and grooves on the exterior angle to expand as best illustrated in FIG. 4. It is contemplated that non-corrugated, flexible tubes may be used which are made of a resilient plastic material that bends laterally with pressure to allow the position of the fluid source to be altered to redirect the fluid spray. Of course, it is contemplated that the would splashguard of the present invention may be moved to more than one position if all portions of the wound cannot be reached by the fluid spray from a single position. Even in such a case, the splashguard of the invention will cut down considerably the number of times the splashguard must be moved when compared with conventional splashguards having a static mount.  
         [0030]    The cup member  43  includes a cylindrical wall  44 , stop surface  45 , and passageway  47 . The cylindrical wall  44  extends from the corrugated tube  42  and defines the periphery of cup aperture  48 . Cup member  43  further includes a bottom wall or stop surface  45  which acts to prevent over-insertion of the fluid source into the passageway  47  and defines the bottom of the cup aperture. The passageway  47  extends through the cup member  43 , tube  42 , and opens into and is in fluid communication with the aperture  37  of the wound shield  30 . The passageway  47  is dimensioned to receive and pass through to the interior of the shielded space the narrow portion of the fluid source which ejects the fluid spray (typically a needle). In the embodiment shown in FIGS.  1 - 5 , cup member  43  is dimensioned and shaped to receive a standard cylindrical syringe with attached needle in cup aperture  48 . It is contemplated that the cup member may be dimensioned and shaped to receive and retain fluid sources with a wide variety of shapes and sizes, including, for example, those having square, rectangular, pentagonal, hexagonal, or octagonal cross-sections.  
         [0031]    The cylindrical wall  44  extends slightly laterally outwardly from stop surface  45  to upper edge  50  of cup  43  so that the preferred cup member aperture  48  of the cup member  43  has a slightly larger internal diameter at upper edge  50  than near the stop surface  45 . As a result, the cup aperture is slightly tapered when viewed from upper edge  50  to stop surface  45  which provides a friction fit with an enlarged diameter portion of the syringe, typically, a needle support or reservoir portion, depending upon the syringe design. It is also contemplated that the cylindrical wall  44  may include an internal spiral flange which corresponds to a spiral ridge on the base of common LUER-LOCK needle support which is used to mount the needle of a syringe to a protective cover. By such friction fit, the needle and needle support of a fluid source may be retained by the splashguard  20  and it may be decoupled from the syringe or other fluid reservoir to refill the syringe. Then, the syringe can be recoupled with the retained needle portion so that the syringe may be refilled without having to re-insert the needle in the splashguard thereby reducing the risk of needle stick injury to the practitioner.  
         [0032]    The fluid source may be any of the fluid sources provided to irrigate wounds in an emergency room or surgical suite. Typically, in an emergency room setting as shown in FIG. 1, a simple syringe  52  with a detachable needle is the fluid source. The needle has an 18 gauge or smaller opening to provide sufficient pressure to the fluid spray and typically has an exterior thread on an enlarged diameter needle support. Such exterior needle support threads are typically twisted onto an interior thread on the syringe to form a detachable coupling of needle support and syringe. In surgical suites, more elaborate fluid sources may be used which have a fluid pump or similar device to provide the pressurized irrigation spray to a needle or similar structure having an opening with a relatively small interior diameter.  
         [0033]    Another embodiment of the invention is shown in FIG. 6 which includes a splashguard  120  having a wound cover  130  and adjustable fluid source mount  140  (hereinafter “mount  140 ”). The splashguard  120  is similar in most respects to that shown in FIGS.  1 - 5  with the exception of the mount  140 . As shown in FIG. 6, the mount  140  includes a ball portion  142  which is received in a socket portion  141 . As shown in FIG. 5, the socket  141  is integrally formed with the wound cover  130 . The wound cover  130  and socket portion  141  are preferably integrally formed by injection molding or blow molding a plastic resin of the type discussed previously above. The socket portion  141  defines an aperture  137  formed in the wound cover  130 .  
         [0034]    The ball member  142  is preferably molded as a separate piece and has a cup member  143  defining a cup aperture  148  which receives a fluid source (not shown). The ball portion  142  is preferably dimensioned so that it can be snap-fit into the socket portion  141 . The ball portion  142  is further designed and dimensioned to pivot and rotate within the socket so that the position of the fluid source can be altered to direct the fluid spray to different portions of the wound without movement of the shield  120 . The ball  142  is preferably provided with an upper rim  154  which prevents the ball member  142  from over-pivoting or over-rotating such that the cup aperture  148  of the cup member  143  is obstructed by the socket  141 .  
         [0035]    The cup member  143  includes a cylindrical wall  144 , stop surface  145 , and passageway  147  similar to those described above for the embodiment of FIGS.  1 - 5 . Cup aperture  143  is likewise tapered from near the upper rim  154  of the cylindrical wall  144  to the stop surface  145  to provide a friction fit with a portion of the fluid source of predetermined dimensions. As shown in FIG. 6, the splashguard  120  lacks a fructo-conical portion such as that shown in the embodiment of FIGS.  1 - 5 . Such a structure may optionally be included, but is not preferred with the ball-in-socket adjustable mount since it is not deemed to be necessary to facilitate stacking as the ball-in-socket adjustment has a lower profile than the tube mount of FIGS.  1 - 5 . The splashguard  120  is otherwise similar to the embodiment of FIGS.  1 - 5  having similar drainage base, apertures, rim, and dome  136  portions.  
         [0036]    It should be noted that the change in position of the adjustable fluid source mount and fluid source, as shown for example in the embodiments of the invention of FIGS.  1 - 6 , can also change the angle at which the fluid spray meets the wound. This can be advantageous when attempting to remove foreign material from a wound by irrigation. The design of prior splashguards typically directed the spray perpendicularly at the wound and made it difficult to alter the angle without either re-sticking the needle or moving the splashguard. It is further contemplated that the ball-in-socket arrangement of the mount  140  could be replaced with a pivoting cup (not shown) having pivot arms and receiving cavities formed in the wound cover. However, the ball-in-socket arrangement is preferred because it provides redirection of the fluid spray in multiple axis to accommodate wider wounds or abrasions with less movement of the splashguard.  
         [0037]    Another embodiment of the invention is shown in FIGS.  7 - 10 , in which a splashguard  220  including a wound cover  230  and adjustable fluid source mount  240  (hereinafter “the mount  240 ”). The wound cover  230  is similar to those shown above in the embodiments of FIGS.  1 - 6 , with the exception of some changes to accommodate the mount  240 . The mount  240  includes a sliding member  242  having a cup member  243  which, similar to previously described embodiments, has a cylindrical wall  244 , a stop surface  245  and passageway  247 . As can be seen in FIG. 7, the sliding member  242  includes longitudinally extending arms  242   a  and  242   b  preferably made of a flexible resilient material. As shown in FIGS.  8 - 10 , the wound cover  230  has slots or channels  234   a  and  234   b  positioned on the internal walls  239   a  and  239   b  defining aperture  237  which are dimensioned to receive guide members  249   a  and  249   b  located along the lateral edges of the sliding member  242 . The guide members  249   a  and  249   b  are preferably continuous projections extending along both lateral edges of the sliding member from the longitudinal end of one arm  242   a  through the cup member  243  to the end of the other arm  242   b . The guide members  249   a  and  249   b  retain the sliding member  242  within the slots  234   a  and  234   b  such that the cup member  243  and thereby fluid source may be slid along a substantial portion of the length of the splashguard  220  to direct the fluid spray to different portions of the wound without substantially moving the guard.  
         [0038]    Depending on the thickness of the wound cover  230 , a thickened ridge  257  adjacent to aperture  237  may be required to accommodate the slots  234  in the interior of the wound cover  230  as shown in FIG. 10. The guide members  249   a  and  249   b  of the sliding member  242  are preferably snap fit into channels  234   a  and  234   b.    
         [0039]    As can be best seen in FIGS. 9 and 10, the interior surface of the cylindrical wall  244  has a spiral groove  256  formed therein which may be engaged by a spiral flange on the exterior surface of a needle support (not shown) to securely retain the needle in the mount. The spiral flange on the needle support can be screwed down into the spiral groove  256  of the cup  243  to firmly secure the needle in the cup  243 . The splashguard  220  is otherwise similar to the embodiment of FIGS.  1 - 5  above having a similar base  232 , drain apertures  231  and  233 , rim  235  and dome  236  portions.  
         [0040]    To use the wound splashguard to assist in wound irrigation, the practitioner places the splashguard over the wound and inserts a fluid source containing irrigation fluid into the adjustable fluid source mount so that at least a portion of the fluid source passes through the aperture in the wound cover to the interior shielded space. Preferably, the practitioner pushes a portion of the fluid source, typically a needle support, downwardly into the tapered cup until it is retained by a friction fit. However, if a fluid source with an external spiral flange is selected, it may be screwed down into the cup member of the adjustable fluid source mount.  
         [0041]    If the wound is large, elongated or the irrigation process would be facilitated by directing the fluid source from more than one angle, the practitioner can move the adjustable mount from a first position to at least a second position to re-direct the fluid spray along the wound without having to move the splashguard. Movement or adjustment of the position of the adjustable fluid source mount or fluid source as used herein means any change in position or orientation of the fluid source whether by sliding, pivoting, rotating or bending the mount which causes a significant redirection of the fluid spray. For example, this movement may be by the practitioner bending the tube  42  of the mount  40  of the embodiment of FIGS.  1 - 5 , rotating or pivoting the ball member  142  of the embodiment of FIG. 6, or sliding the sliding member  242  of the embodiment of FIGS.  7 - 10 .  
         [0042]    If a refillable fluid source such as a syringe is used, the practitioner can refill or replace it with a full fluid reservoir. This can be accomplished by the practitioner decoupling the needle support portion of the fluid source (typically by unscrewing it from the fluid reservoir), refilling or replacing it with a full reservoir, and recoupling it to the retained needle support portion. As the fluid ejecting portion of the fluid source is preferably retained by the cup member of the splashguard, the practitioner can avoid re-sticking the splashguard when refilling or replenishing the fluid source. This feature can reduce the likelihood of needle stick injury to the practitioner.  
         [0043]    After irrigation is complete, the wound splashguard is removed from the wound and the fluid source is disengaged from the splashguard. Preferably, in the emergency room setting, both the fluid source and splashguard are made of relatively inexpensive plastic resins and both may be disposed of by the practitioner. However, in the surgical suite setting, it may be desirable to have a reusable fluid source and splashguard that are made of a material which can withstand disinfection by autoclave or other suitable means. In this case, the practitioner removes the fluid source from the splashguard and places the wound guard in an appropriate location for disinfection with other surgical implements.  
         [0044]    The applicant has provided description and figures which are intended as an illustration of certain embodiments of the invention, and are not intended to be construed as containing or implying limitation of the invention to those embodiments. It will be appreciated that, although applicant has described various aspects of the invention with respect to the specific embodiments, various alternatives and modifications will be apparent from the present disclosure which are within the spirit and scope of the present invention as set forth in the following claims.