Abstract:
A splash-shield and related fluid delivery device is intended for medical irrigation or lavage of compromised areas of skin. The device includes a passage for fluid to exit into a bell. The passage exits into the bell closer to one edge of the bell, but is angled toward the other end of the bell, where there are bights defining drainage openings. The angled passage imparts a directional component to the fluid stream which, along with any available gravity drainage, encourages the irrigant to flow over the compromised area and out of the bell. The splash-shield is egg-shaped to cover a larger compromised area and to further enhance the distribution of irrigant. The rim of the bell is shaped to discourage unintended splashing of spent irrigant onto the administering personnel or the patient, while nonetheless allowing for efficient irrigation.

Description:
FIELD OF THE INVENTION 
     This invention relates to medical devices and, more particularly, to a splash-shield and related fluid delivery device for providing effective irrigation while also preventing the splash of contaminated irrigating fluids onto administering personnel. 
     BACKGROUND OF THE INVENTION 
     Irrigation and lavage (referred to collectively as “irrigation”) are commonly used in medicine to cleanse areas of the body of microscopic and macroscopic foreign contamination. Such areas of the body shall be referred to herein as “compromised areas.” Such compromised areas include skin or wounds contaminated with infectious organisms, such as hepatitis virus, human immunodeficiency virus, or with biologically or chemically toxic matter. In such cases, medical personnel endeavor to remove the contaminant through copious irrigation, often with a saline solution. The fluid used to irrigate such compromised areas, the so-called “irrigant,” will generally become contaminated itself after contact with and irrigation of the infected area. If this contaminated irrigant contacts other, uninfected areas of the patient, there is a risk of further infection, which is obviously undesirable. 
     Accordingly, there is a need to drain or remove the contaminated irrigant from unnecessary further contact with the uninfected or uncompromised areas of the patient. 
     There is also a risk that the contaminated irrigant will contaminate the administering medical personnel. Syringes and needles are commonly used in a variety of configurations to provide irrigation. As such, the irrigant generally exits from a fluid delivery nozzle toward the compromised area under pressure, and if the fluid stream is not properly directed, controlled, or circumscribed, the contaminated irrigant will “splash back” onto, or otherwise make unintended contact with the administering personnel. This undesirable risk of being splashed with contaminated irrigant is all the more acute when copious amounts of irrigant are used or delivered under high pressure. 
     There is, accordingly, a further need to protect the administering personnel from undue exposure to contaminated irrigant splashing back from the compromised area or otherwise contacting such personnel. 
     The syringes and needles typically used in irrigation generally do not themselves protect either the patient or administering personnel from splash back of contaminated irrigant or undesired contact therewith. The current art has attempted to overcome this disadvantage, but such attempts have there own drawbacks and disadvantages, or have been generally ineffective. 
     For example, administering personnel often take universal or general precautions against contamination, such as impermeable gloves, clothing barriers, eye protection, and face-masks. To assure adequate protection from such general precautions, however, they are generally combined, in hopes of synergistically enhancing protection from contamination. This approach has the disadvantage not only of greater expense, but also greater inconvenience to the administering personnel, as well as excessive time spent in taking precautionary measures. 
     Moreover, the use of syringes or needles risks causing further injury to soft tissue structures, such as vessels, nerves, tendons, or other subcutaneous structures often found within a wound or other compromised area during the irrigation process. In the case of sharp needles attached to a syringe for purposes of irrigation, there is also the risk of delivering irrigant at excessive pressure and thereby further damaging the area. There is likewise the risk of puncture with a contaminated needle, either to the administering personnel or the patient. 
     One approach to solve the above-described drawbacks and disadvantages is to provide the syringe or other fluid delivery device with a shield to prevent undesired splash back of contaminated irrigant. An example of this approach is found in U.S. Pat. No. 4,769,003 (Stamler). The shield in Stamler is designed to be tilted in proximity to the area being treated to allow drainage. One of the drawbacks of this approach, however, is that the exiting fluid stream may become, under certain circumstances, difficult to direct as desired, or may not be adequately controlled or circumscribed by the disclosed structure. Under such circumstances, it is possible for both the patient and the administering personnel to come into unnecessary contact with contaminated irrigant. 
     Further examples of shields on fluid delivery devices are found in U.S. Pat. No. 5,735,833 (Olson); U.S. Pat. No. 5,030,214 (Spector); and U.S. Pat. No. 4,692,140 (Olson). These approaches, however, also suffer from various drawbacks and disadvantages. For example, irrigant may be dispersed inefficiently by the structures disclosed in these references. Further, the disclosed prior art devices can be cumbersome to use in certain situations, or may likewise be cost prohibitive. As such, these devices may not be well suited for applications requiring either portability of the device, or disposal after use. 
     A solution is thus needed which better balances the often competing interests associated with irrigation of compromised areas of the body. 
     It is desirable to balance the need to cleanse the compromised area quickly and effectively, with the need to protect both the patient and the medical personnel from unnecessary contact with the irrigant. 
     A device is needed which delivers irrigant at sufficient volume to cleanse the area, but not at such high pressure as to damage the area. 
     Notwithstanding the copious volume of irrigant which may be required, a device is needed to prevent the irrigant from splashing back onto the administering personnel, but in so doing, the device should also minimize the undesirable contact of contaminated irrigant with uncontaminated areas of the patient. 
     Still further, it is desirable for the device to be easy to use in emergency situations, and adaptable for use with various different syringes or still other fluid delivery devices. 
     SUMMARY 
     A medical device according to the present invention delivers irrigating fluid to a wound or other compromised area of a patient and includes a splash-shield for controlling (or “circumscribing”) the flow of the irrigant to minimize undesired contact with spent or contaminated irrigant, especially irrigant that splashes off of the area being irrigated. The structure of the splash-shield which circumscribes the flow of irrigant keeps the spent or contaminated irrigant away from not only the administrating personnel, but also the patient. A bell on the splash-shield has a proximal and a distal end, and the bell terminates in a rim with a rounded lip formed thereon. A fitting is formed at the proximal end of the bell, and the fitting is designed with a passage therein to receive the exit end of a fluid delivery device. The passage extends through the surface of the bell at an angle relative to the plane of the rim. At least one, preferably two bights are formed in the rim of the bell to define a corresponding drainage opening or openings. 
     In one version of the invention, the rim can be thought of as having a leading edge and a trailing edge opposite the leading edge. The passage exits at a location on the inner surface of the bell which is closer to the trailing edge than the leading edge, and the passage is oriented toward the leading edge. The drainage opening, in contrast, is located on the opposite leading edge. In this way, the fluid exiting the passage, although directed at the compromised area for irrigation purposes, also has a directional component toward the leading edge. This directional component toward the drainage openings is thought to improve the efficacy of irrigation and encourage drainage of spent irrigant through the drainage opening. 
     In accordance with another aspect of the invention, the bell has a radius increasing from the proximal end to the distal end, but with the radius at the leading edge increasing more rapidly than the radius at the trailing edge. As such, the bell encloses a volume in the shape of a half egg, and the rim encloses an elongated, ovate or egg-shaped perimeter. 
     The splash-shield, in accordance with other aspects of the invention, is removably received on the exit nozzle of any of a variety of delivery devices for the irrigant. Such delivery devices have a reservoir of fluid irrigant in hydraulic communication with the exit nozzle, and a suitable structure for expelling the fluid from the nozzle. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     These and other aspects of the invention are explained by the description below, in conjunction with the drawing, in which: 
     FIG. 1 is perspective view of a splash-shield according to the present invention, shown positioned over a compromised area of a patient&#39;s body to be irrigated; 
     FIG.  2 . is a front elevational view of the splash-shield of FIG. 1; 
     FIG. 3 is a side elevational view of the splash-shield of FIG. 1; 
     FIGS. 4 through 6 are rear, top, and bottom views of the splash-shield of FIG. 1; 
     FIGS. 7 through 11 are cross-sectional views of portable medical devices according to the present invention in combination with the splash-shield of FIGS.  1 - 6 . 
    
    
     DESCRIPTION 
     Referring now to the drawing, and in particular to FIGS. 1-6, thereof, a fluid delivery device  21  of the present invention comprises a splash-shield  23  with certain structural features which control the flow of irrigating fluid, thereby keeping spent or contaminated irrigating fluid from undesired contact with either the administering personnel or the patient. In this embodiment, splash-shield  23  is shown removably mounted to a connector  25  at the exit end of a fluid delivery device, such as those shown in FIGS. 7-11. In particular, connector  25  has a nozzle end  27  which extends through a passage  29  of the splash-shield  23 . The passage  29  is formed in a fitting  31  at proximal end  33  of splash-shield  23 . As schematically shown in FIG. 1 by dark headed arrows, irrigating fluid exits from nozzle end  27  and irrigates compromised area  35  which is enclosed by splash-shield  23 . 
     Passage  29  is oriented by an angle α, preferably about 15°, toward a pair of bights  34 , which serve as drainage openings. The angle α of passage  29  imparts a directional component to the exiting fluid toward bights  34 . Thus, although the irrigating fluid is directed toward compromised area  35  for purposes of irrigation, it also is directed toward the drainage openings. As shown in FIG. 1, splash-shield  23  is preferably positioned so that the drainage openings are downward from the compromised area  35 , allowing gravity to assist in draining spent or contaminated irrigant from compromised area  35 . Nonetheless, the directional component toward the drainage openings imparted by the angle α of passage  29  is also believed to encourage spent irrigant to leave the compromised area under treatment more efficiently, thereby reducing risk of either recontaminating irrigated areas or contaminating areas not under treatment. The structures of splash-shield  23  described above also allow administering personnel to better anticipate the flow of irrigant, so that such flow can be directed generally away from the administering personnel. In this way, the administering personnel are less likely to come into contact with irrigant as it drains from bights  34 . 
     Splash-shield  23  includes additional structural features which control or circumscribe flow of irrigant, especially in regard to splash back of irrigant, and which are believed to render irrigation more efficient. Splash-shield  23  includes a bell  37  which extends from proximal end  33  in increasing radius r (FIG. 3) to terminate in rim  39  at distal end  41  of bell  37 . Rim  39  defines an egg-shaped or ovate perimeter  43 , best seen in FIG.  6 . 
     Passage  29  extends between outer surface  47  of bell  37  and its inner surface  45 , so that fluid can be transmitted from outside the bell  37  to the compromised area  35  enclosed by inner surface  45  of bell  37 , as discussed above. 
     Rim  39  has a rounded lip  49  formed over substantially all its perimeter. The rounded lip has a radius sufficiently large, preferably about {fraction (3/64)}″, to reduce the risk of damaging the already compromised area  35 . For purposes of better understanding the present invention, rim  39 , which extends through a 360° arc, can be divided into a leading edge  51  and a trailing edge  53  at opposite ends of such 360° arc. It is to be understood that the terms “leading” or “trailing” are not intended to limit such rim locations to particular orientations or functions relative to the compromised area  35 , as such orientations or functions will vary depending on the particular compromised area  35  being treated, as well as the sound judgment of the administering personnel operating the splash-shield  23 . Passage  29  exits on inner surface  45  at a location closer to trailing edge  53  than leading edge  51 , as best seen in FIG.  6 . 
     Bell  37  is symmetrical about a longitudinal plane  55  (FIG.  2 ). Passage  29  lies in longitudinal plane  55 . The bights  34  are located on respective sides of longitudinal plane  55 , and rim  39  has sides  52  extending substantially in a single plane from trailing edge  53  to respective ones of the bights  34 . 
     Radius r of bell  37  increases more rapidly at arcuate locations corresponding to leading edge  51  than at corresponding locations of the trailing edge, with the result that bell  37  encloses a volume in the shape of a half egg. Rim  39  can be thought of as having a major longitudinal axis  57  which extends between leading edge  51  and trailing edge  53 , and a minor transverse axis  59  perpendicular to major axis  57 . Major axis  57  is longer than minor axis  59 , so that bell  37  is elongated in the dimension between the leading and trailing edges  51 ,  53 , and the corresponding area of the body enclosed by bell  37  and subject to treatment is correspondingly lengthened and thereby enlarged. 
     The angle of passage  29  causes fluid to exit nozzle  27  not only downwardly toward compromised area  35 , but also in the elongated, longitudinal direction of bell  37  and toward the drainage openings. The lengthened area enclosed by rim  39 , the location of the passage  29  toward the trailing edge  53 , its angular orientation both toward the leading edge  55  and along the major, longitudinal axis, and the half-egg volume enclosed by bell  37 , are believed to efficiently distribute irrigant over the compromised area  35  enclosed by rim  39 , and are likewise believed to allow for efficient drainage of such irrigant through bights  34 . 
     In operation, of course, components of the fluid stream rebound from compromised area  35  not only toward the drainage openings, but in other random directions as well. The substantially planar sides  52  of rim  39 , and the coplanar trailing edge  53 , allow splash-shield  23  to be brought into substantial contact with the surface of the compromised area  35  during irrigation. The rounded lip  49  permits rim  39  to be brought into contact with, or close proximity to the area  35  being treated under most situations. The fluid rebounding in random directions is inhibited from exiting the volume enclosed by bell  37  by the contact of the planar sides  52  and trailing edge  53  with the surface of the area being treated. In this way, the administering personnel and the patient is spared undesired contact by spent irrigant. 
     Outer surface  47  has indicia located toward leading edge  51  along axis  57  for indicating the position of the fluid stream exiting passage  29  relative to the compromised area  35 . In this embodiment, such indicia comprise a raised region in the form of an arrow  61 . Outer surface  47  is also provided with means for assisting the administering personnel in placing his or her fingers on splash-shield  23  to hold bell  37  in position, such means here shown as a pair of protrusions  63  located on opposite sides of bell  37  between the leading and trailing edges  51 ,  53 . 
     Splash-shield  23  is preferably molded from clear, polymeric material suitable for medical devices, to enable administering personnel to visualize the fluid stream with respect to the compromised area  35 . Although the exact dimensions of the structural features of the splash-shield  23  may be varied to suit different applications, in the preferred embodiment, the major, longitudinal axis  57  extends about 2 inches and the minor, transverse axis  59  is about 1.5 inches. Though the rim  39  lies preferably in a single plane with the exception of the bights  34 , the present invention is not limited thereto. The bights  34  are positioned at about 40° from the longitudinal plane and have radii of about 0.25 inches. The passage  29  exits on inner surface  45  of bell  37  at a height above rim  39  of between about 0.75 inches to about 1 inch. Passage  29  is tapered from a diameter of about {fraction (17/64)} of an inch to about {fraction (11/64)} of an inch, to enable friction fit of nozzle end  27  in a variety of forms as discussed below. 
     Referring now to FIGS. 7-11, a splash-shield is part of a medical device according to the present invention for irrigating compromised areas  35 . Such medical devices as shown in FIGS. 7-11 and described herein are preferably portable, suitable for irrigation under emergency department conditions, and include a reservoir of fluid irrigant, a fluid exit nozzle or tube, a splash shield mounted to such nozzle, and suitable structures to expel the fluid from the reservoir through the nozzle or exit end of the tube. 
     In one preferred embodiment shown in FIG. 7, a squeeze bottle  124  includes a delivery fitting  126  with one connector side mounted to a cap  130  of the bottle  124  and a second, opposite male connector  128  received in a friction fit into fitting  131  of bell  137  of splash-shield  123 , which splash-shield has the structural features described and shown in FIGS. 1-6. The delivery fitting  126 , bottle  124 , and cap  130  are further described in U.S. Pat. No. 5,795,324 issued to the same inventor, and the teachings of such disclosure are incorporated herein by reference. 
     A second embodiment of a fluid delivery device of the present invention is shown in FIG. 8, in which a syringe  224  has a blunt nose  226  received into fitting  231  of splash-shield  223 , which splash-shield has the structural features previously described and shown in FIGS. 1-6. FIG. 9 shows a further variation, in which an extension tube  330  is connected between the blunt nose  326  of syringe  324  and splash-shield  323 . This variation allows for more flexible placement of splash-shield  323  in relation to syringe  324 , as may be needed, for example, to treat compromised areas (not shown) which are less accessible or inconveniently located in relation to the administering personnel. 
     Still further embodiments of the present invention are shown in FIGS. 10 and 11. One end of delivery fitting  426  is a male-type connector adapted to “spike” into an IV bag  424 . The other end of delivery fitting  426  is a male-type connector adapted to frictionally insert into fitting  431  of splash-shield  423  in the case of FIG. 10, or into the appropriate end of extension tubing  430  in the case of FIG.  11 . The structure and use of delivery fitting  426  is further described in U.S. Pat. No. 5,931,820 issued to the same inventor, and its teachings are incorporated herein by reference. 
     Operation of the splash-shield and associated fluid delivery device is readily apparent from the foregoing description. A suitable configuration of fluid reservoir is selected, and an appropriate connector with or without extension tubing is interconnected between the fluid reservoir and the splash-shield. The administering personnel place the splash-shield against or very close to the compromised area to be treated. The splash-shield is preferably oriented so that drainage through bights  34  is gravity-assisted and, where possible, so that the flow of irrigant is away from the administering personnel. Fluid exiting splash shield  23  through bights  34  may be contained by absorbent material such as towels or collected by a suitable container. The portability of the device obviously allows the splash-shield to be applied in any orientation so as to substantially enclose the compromised area to be treated. 
     Once the splash-shield has been appropriately positioned, the administering personnel expels the fluid as appropriate to the particular situation, typically saline solution, by whatever means are appropriate to the fluid reservoir selected, namely, movement of a plunger in the case of a syringe, or squeezing the flexible sides of a squeeze bottle or IV bag. 
     In addition to the advantages apparent from the foregoing description, the fluid delivery device of the present invention accomplishes efficient irrigation or lavage, while at the same time minimizing undesired contact of the administering personnel or patient with spent or contaminated irrigant. In particular, the device minimizes “splashing” of the irrigant outside the treatment area. 
     The splash-shield can be advantageously placed against most compromised areas with less risk of further compromising the area. 
     As still another advantage, the irrigation device is cost effective and easy to operate quickly, such as may be required in emergency interventions. 
     The present invention has been described with reference to particular preferred embodiments. Such description is for purposes of setting out the best mode of practicing the invention for one skilled in the art, and is not intended to limit the invention to the particular instrumentalities disclosed. Still further variations to the described invention may be appreciated by those skilled in the art, or as skill or fancy may suggest, the invention thus being defined only by the appended claims and encompassing equivalent structures thereto.