Patent Publication Number: US-2005124946-A1

Title: Wound irrigation apparatus and method

Description:
FIELD OF THE INVENTION  
      This invention relates to wound irrigation and cleansing. More particularly, the present invention relates to a portable wound irrigation liquid dispenser apparatus for delivering a pressurized stream of wound cleansing liquid, and to a method of making and operating such an apparatus.  
     RELATED TECHNOLOGY  
      Wounds, lacerations, abrasions, and other traumatic injuries to the skin are among the most common problems treated in emergency departments. To prevent infection wounds must be cleaned of bacteria, dirt, and other foreign material before repair (i.e., suturing) is attempted. Unfortunately, traditional methods for cleaning wounds frequently result in one or more of: further trauma to injured tissue, inadequate cleansing, safety hazards for the patient, and safety hazards for the healthcare provider. An ideal wound cleansing system would be characterized by: 
          Efficacy in cleaning wounds of bacteria and foreign material,     Ease and efficiency of use,     Patient and healthcare provider safety, and     Low cost        

      A common and long-employed method of wound cleaning involves scrubbing a wound with an antiseptic solution, using gauze or a brush to scrub dirt, debris, and bacterial contamination out of the open wound.  
      However, most antiseptics are toxic to open tissue, and brushes and gauze cause further tissue injury. Deficiencies of this method include impaired healing, increased incidence of infection, and unnecessary scarring.  
      In recent years, wound irrigation has emerged as the standard of care for wound cleaning. This method is recognized and recommended by most experts and emergency medical textbooks. Wound irrigation involves directing a stream of liquid into the open wound. Sterile saline solution, several hundred milliliters in volume, at pressures of 8-15 psig, is most commonly used. The fluid stream dislodges foreign material from wounds with minimal tissue trauma.  
      Several irrigation systems and devices are known. One of the most common methods involves attaching an I.V. catheter tip to the end of a 20-60 ml syringe. The healthcare provider pours irrigation fluid into a basin, then repeatedly draws up, directs, and sprays the fluid from the syringe, through the catheter tip, and into the wound. Principle deficiencies of this method include inefficiency of the repeated drawing and spraying action, and potential for backsplash of fluid onto healthcare providers.  
      Another common, but deficient, irrigation method involves simply puncturing the cap or lid of a plastic bottle of irrigation solution (i.e., saline solution) with a large bore needle, then spraying liquid directly from the punctured bottle. Although this method is quick and easy to perform, deficiencies of this method include a significant potential for injury when puncturing bottles with the needle, and backsplash of contaminated liquid from the wound onto the healthcare worker. Additionally, this method seems to encourage the use of leftover fluid on other patients. This is the case because most saline bottles contain 1000 ml, and wounds generally require less than 500 ml. for adequate cleansing. However, these common saline bottles are not intended for multiple use, a practice which carries risks of cross contamination with viral and bacterial organisms.  
      A number of devices have been developed to address the problem of backsplash of contaminated liquid onto the healthcare worker. These devices commonly feature a small conical shield around a central nozzle. The devices attach to a luer tip syringe. Although liquid backsplash from a wound is effectively reduced or even eliminated, these devices still suffer from an undesirable inefficiency. That is, these devices require repeated removal of the splash shield, drawing up of the irrigation fluid, replacing the shield, then spraying the irrigation fluid into the wound.  
      Newer adaptations of some of these conventional devices utilize tubing to connect the syringe setup to either a bag or basin containing the fluid, in order to permit easier refilling of the syringe, without removal of the splash shield. That is, a check valve arrangement in the tubing allows the syringe to by filled, and then allows the irrigation fluid to be discharged into the wound without removal or replacement of a splash shield. Although efficiency of wound treatment is enhanced (albeit at the expense of additional parts and procedural complexity) the need for the repeated actions of aspiration and expulsion of fluid into and from a syringe still remains.  
      Another conventional wound irrigation device addresses the disadvantage of repeatedly having to fill and discharge a syringe by use of an adapter that allows a splash shield to be “spiked” directly into an IV bag. With this device, healthcare providers need only squeeze the IV bag to expel the solution. However, deficiencies still remain. With this apparatus, spillage of the irrigation liquid may occur whenever the bag is set down during a procedure, or afterwards when the bag and leftover fluid are discarded into a waste container. Additionally, this device requires “spiking” a sharp tip into an IV bag, creating an injury hazard for the healthcare provider.  
      Yet another version of irrigation involves an aerosolized or pressurized canister of irrigation fluid. Deficiencies of this apparatus and method include a lack of backsplash protection, an inability to monitor amount of fluid expelled, and a potential for reuse of the apparatus on multiple patients.  
     SUMMARY OF THE INVENTION  
      In view of the deficiencies of the conventional technology, an object for this invention is to avoid or reduce at least one of these deficiencies.  
      It is an object of this invention to provide a portable wound cleansing device that includes a nozzle and splash shield which directs a pressurized jet or stream of wound cleaning liquid upon and into a wound with good control and accuracy of the delivered stream of cleaning liquid.  
      It is yet another object of this invention to provide a wound cleansing apparatus that effectively removes foreign materials, including for example particles and bacteria, from a wound.  
      It is yet another object of this invention to provide a wound cleansing apparatus that attaches directly to standard plastic bottles of irrigation fluid (i.e., saline solution), thus eliminating the need to repeatedly aspirate and eject fluid into and from a syringe.  
      It is yet another object of this invention to provide a wound cleansing device that protects the healthcare provider from fluid splashing off the wound during irrigation.  
      It is yet another object of this invention to provide a wound cleansing device that does not required the use of syringes, needles, spike adapters, or other hazardous objects.  
      It is yet another object of this invention to provide a portable wound cleansing device that provides visual indication of how much wound cleansing liquid remains in the device.  
      It is yet another object of this invention to provide a portable wound cleansing device which provides visual indication that the bottle of fluid has already been used on a prior patient.  
      It is yet another object of this invention to provide a portable wound cleansing device that prevents spillage of irrigation fluid during procedural interruptions as well as after the procedure.  
      Accordingly, this invention provides: a portable, manually-operated, wound cleansing liquid dispenser apparatus consisting of: a manually-squeezable saline irrigation solution container for holding and selectively delivering sterile wound irrigation cleansing liquid, the container having a threaded neck; a cap threadably engaging at the threaded neck. The cap carries a nozzle from which wound cleansing liquid issues as a jet in response to manual squeezing of the container. The cap defines a liquid flow path leading to the nozzle; and a splash shield surrounds the nozzle for protecting a user of the apparatus from splashing liquid. Further, a valve is disposed in the flow path. This valve may be configured for opening and closing the flow path in response to manual movement of the splash shield between a first and a second position.  
      These and other objects of the invention will become apparent to those working in the art by reference to the following description, including the accompanying drawings which illustrate two preferred exemplary embodiments of the invention. 
    
    
     BRIEF DESCRIPTION OF THE DRAWING FIGURES  
       FIG. 1  is a diagrammatic side elevation view, partially in cross section, of a wound irrigation apparatus embodying the present invention, and which is shown during its use to clean a wound;  
       FIG. 2  is an enlarged fragmentary view of a portion of  FIG. 1  and showing the apparatus according to this invention;  
       FIG. 3  is an exploded perspective view of the apparatus seen in  FIGS. 1-2A ;  
       FIG. 4  provides a fragmentary cross sectional view of an apparatus as seen in  FIGS. 1-3 , but with the apparatus shown in a storage or shipping configuration prior to use.  
       FIG. 5  is an enlarged fragmentary view similar to  FIG. 2 , but showing an apparatus according to an alternative embodiment of the present invention;  
       FIG. 6  provides an exploded perspective view of the apparatus seen in  FIG. 5 ;  
       FIG. 7  is a fragmentary cross sectional view of the apparatus seen in  FIGS. 5 and 6 , and is illustrated in a use configuration of the apparatus;  
       FIG. 7A  is a fragmentary cross sectional view of the apparatus seen in  FIGS. 5 and 6 , and is illustrated in an alternative use configuration of the apparatus;  
       FIG. 8  is a fragmentary cross sectional view of the apparatus seen in  FIGS. 5-7 , but is shown in a storage or shipping configuration prior to its use; and  
       FIG. 9  provides a fragmentary cross sectional view of the apparatus according to  FIGS. 5-7 , in a configuration it may have in the event of an attempt to make an improper use of the apparatus. 
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       FIG. 1  shows a portable wound cleansing apparatus  10  for dispensing a pressurized (i.e., of selected or controlled velocity) jet or stream of sterile wound cleansing liquid upon and into an open wound. Particularly, the apparatus  10  is generally illustrated in  FIG. 1  as it would appear in a use configuration while being held in the squeezing hand  12  of a user  14  (only the hand and wrist of the user  14  being seen in the drawing Figures), who is directing a stream  16  of wound cleaning liquid upon and into a wound  18  of a patient  20  (only a small portion of whom is seen in the drawing Figures).  
      As is seen in  FIGS. 1-4  the apparatus  10  includes a flexible container or plastic bottle  22 , which preferable is a standard transparent or translucent plastic saline bottle containing sterile saline irrigation solution, and which is well known and common in the medical field at this time. Threadably attached to the externally threaded neck  22   a  of the bottle  22  is a dispenser apparatus (generally referenced with the numeral  24 ) according to a preferred embodiment of this invention.  
      Viewing  FIGS. 1-4  in conjunction with one another, and particularly viewing  FIGS. 2 and 3 , it is seen that dispenser apparatus  24  includes a cap portion  26  defining a collar portion  28  with internally formed (i.e., female) threads  30  for threadably engaging onto the threads of the neck  22 A of the bottle  22 . Most preferably, the thread  30  is a buttress thread form having a minor diameter of substantially 1.347 inches, and a pitch dimension of 0.164 inch. The female buttress thread shape is preferably formed with the one thread form surface which is disposed toward the container  22  being truly radial (i.e., at an angle of 90° to the axis of the cap) and the other thread form surface at an angle of 46.1° relative to the first surface. Thus, the female thread  30  can threadably engage onto an industry-standard 45° male buttress thread form on the container  22 .  
      Further, the cap portion  26  includes an end wall section  32  inwardly defining an axially extending and slightly tapering sealing collar portion  34 . This collar portion  34  is sealingly received inwardly of the neck  22 A of the bottle  22 , and cooperates with this bottle neck to contain pressurized liquid within the cap  26 . That is, the inside of the cap  26  communicates with a cavity  22 ′ of the bottle  22 , and with sterile cleansing liquid in this bottle  22 , which is pressurized as seen in  FIG. 1  because of the user  14  forcefully squeezing with the hand  12 .  
      Outwardly, the wall section  32  of cap  26  includes a tubular neck section  36  defining a through bore  38 . A conical bore section  40  is formed on the through bore  38 , and the purpose of this conical section  40  will be explained below. Outwardly, the tubular neck section  36  defines an external cylindrical surface  42 , defining a retention collar feature  44  at its distal (i.e., forward) end or termination. Behind the retention collar feature  44 , this external surface  42  of the neck section  36  also defines an annular axially extending radial recess  46 .  
      Slidably and captively received on the tubular neck section  36  is a closure and splash guard member, generally indicated with the numeral  48  (hereinafter, “splash guard”). This splash guard  48  includes a tubular section  50  which is slidably and captively received over the neck section  36 . Consequently, the splash guard  48  is movable manually between the use position seen in  FIGS. 1-3 , and a closed (i.e., storage or transport) position seen in  FIG. 4 . Further considering the splash guard  48  and its tubular section  50 , it is seen (particularly in  FIGS. 2 and 4 ) that this tubular section  50  terminates in an annular radially inwardly extending retention collar  52 . The retention collar  52  is received on the neck section  36  behind the collar  44  and in the recess  46 . In the recess  46  the collar  52  defines a movable sealing interference fit with the tubular section. Accordingly, the splash guard  48  is slidably movable manually between the two positions seen in  FIGS. 2 and 4 , but is not removable from the neck section  36 .  
      Also seen best in  FIGS. 2 and 4 , it will be noted that the splash guard  48  tubular section  50  defines a bore  56  (i.e., on which the retention collar  52  appears), and that this bore  56  cooperates with the neck section  36  of the cap  26  to define a chamber  58 . The chamber  58  communicates with the chamber  22 ′ of the bottle  22  via the tubular neck section  36 . At the chamber  58 , the tubular section  50  defines a pair of oppositely axially disposed annular shoulders (or abutments)  60   a  and  60   b . It will be noted that chamber  58  also communicates via the annular abutment surface  60   b  to a conical converging section  62  of the bore  56  with a nozzle opening or aperture  64 . The nozzle opening  64  is defined by the splash guard  48  on a nozzle protrusion  66  defined within a surrounding annular transparent splash shield portion  68  of the splash guard  48 . The splash shield  68  extends radially outwardly of and forwardly of the nozzle opening  64  and nozzle protrusion  66 . As is seen in  FIG. 1 , this splash shield  68  is effective to prevent or reduce liquid from the jet  16  and wound  18  from splashing back toward and upon the user  14 .  
      Turning again to  FIGS. 3 and 4 , it is seen that movably received in the chamber  58  (that is, in bores  38  and  56  of the neck section  36  and of tubular section  50 , respectively) is a valve member  70 . This valve member includes a stem portion  72  extending through the bore  38  to (in the position seen in  FIG. 4 ) extend slightly into the chamber  22 ′ of bottle  22 . In the conical bore portion  40 , the stem portion  72  defines a matchingly shaped conical valve portion  74 . Forwardly of the conical valve portion  74 , the valve member  70  includes a plurality of radially outwardly and axially extending fin members  76  (best seen in  FIG. 3 , and only two of which are seen in  FIGS. 2 and 4 ). These fin members  76  each engage at respective oppositely axially disposed end edges  76   a  and  76   b  with the annular abutment surface  60   a  and  60   b . Consequently, the valve member  70  moves axially with the splash guard member  48 , and in the position of the splash guard member  48  seen in  FIG. 2 a  liquid flow path (indicated by the arrowed numeral  80 ) is maintained from chamber  22 ′ along bore  38  to chamber  58 , along bore  56 , past the annular abutment surface  60   b  (i.e., between the plural fins  76 ), along the conical section  62 , and to nozzle opening  64 . Thus, as is seen in  FIGS. 1 , and  2 , liquid can flow from the bottle  22  (i.e., because of the squeezing pressure manually applied by the user, as is seen in  FIG. 1 ) to be ejected from the nozzle opening  64  as a jet or stream of cleansing liquid.  
      Accordingly, the user of the apparatus  10  may cleanse and irrigate a wound as is seen in  FIG. 1 , by applying manual pressure to the bottle  22 , ejecting a stream or jet of cleansing liquid  16  from the nozzle  64 . The transparent splash shield  68  allows the user to see the direction and effect of the jet  16  of cleansing liquid, while substantially reducing back splash of contaminated liquid toward the user of the apparatus  10 .  
      Turning now to  FIG. 4 , the configuration of the apparatus  10  during transport or storage (i.e., prior to use) is illustrated. In this configuration the splash guard member  48  is disposed axially along the tubular neck  36  toward the cap  26 , and is retained in its closed position by the sliding interference fit of the collar portion  52  in recess  46 , as illustrated. Further, the valve member  70  is retained in its closed position by the splash guard  48  in a closed position along neck  36 , because the annular abutment surface  60   a  engages against the ends  76   a  of the fins  76  and holds the valve  70  in its closed position, viewing  FIG. 4 . Additionally, in this storage or transport configuration of the apparatus  10 , an indicator disk member  82  (i.e., a tell-tale member) is received in the chamber  22 ′ of the bottle  22  and is captively but releasably retained on the stem portion  72 . This indicator disk  82  defines a central hole or aperture  84  surrounded by a radially extending plurality of slots  84   a . Consequently, between the slots  84   a , the disk  82  defines a radial plurality of resilient finger portions  84   b . The finger portions  84   b  captively but releasably engage about an end portion feature  86  (to be further described below) of the stem  72 . The disk member  82  also engages against a surrounding shoulder  88  within the cap  24 . Further, the disk  84  defines a pair of flow path notches  84   c . These flow notches are important because they insure that the disk member  82  does not block liquid flow from the bottle  22  in the event that the apparatus  10  is quickly brought into use (i.e., the splash guard  48  is pulled to its open position essentially simultaneously with the application of squeezing pressure on the bottle  22 ).  
      When the splash guard member  48  is moved from its first or closed position of  FIG. 4 , and to its second or opened position as seen in  FIG. 2 , then a snap fit feature  86  of the stem portion  72  which is captively received in this aperture  84  among the finger portions  84   b  is pulled from the disk  82 . Because the disk member  82  is engaged against the shoulder  88 , it is then released into the chamber  22 ′, thereafter clearly indicating that the apparatus  10  has been used.  
      Once the apparatus  10  has been thus opened and used or prepared for use, the tell-tale aspect of the member  82  comes into play. Because the member  82  is dislodged from the end of stem  72 , and because this member is preferably formed of plastic having a specific gravity slightly less than water (i.e., less than saline solution), the member  82  floats freely on the surface of any cleansing liquid remaining in the apparatus  10 . Thus, the member  82  is preferably made of a plastic which is brightly colored and easily visible. And, the presence of the floating member  82  on the liquid in an apparatus  10  indicates that the apparatus has been used or opened previously, and is to be used only for the patient for which it was opened, and is not to be used on a subsequent different patient. Again, and in view of the above, it will be understood that a user of the apparatus  10  preparatorily grasps the splash shield  48  and pulls it outwardly along the neck  36  from its position of  FIG. 4  and to the position of  FIG. 2 . This preparatory move of the splash shield  48  allows squeezing pressure to move liquid past valve member  70  and along flow path  80  so that the user can discharge a stream of cleansing liquid upon and into a wound as is seen in  FIG. 1 . And this preparatory move of the splash shield member  48  also and simultaneously releases the disk member  82  inside of the bottle  22  so that thereafter the apparatus is recognizable as “used,” and not suitable for use on another patient.  
      Turning now to  FIGS. 5-8 , an alternative embodiment of the present invention is illustrates. In order to obtain reference numerals for use in describing the alternative embodiment of  FIGS. 5-8  features of this embodiment which are the same as or analogous to those illustrated and described earlier with respect to  FIGS. 1-4  are referenced on  FIGS. 5-8  using the same numeral increased by one-hundred (100).  
       FIG. 5  is similar to  FIG. 2 , and shows the apparatus  110  during its use to discharge a jet or stream of cleansing liquid  116 .  FIG. 6  illustrates the apparatus  110  in cross section, and shows that this apparatus includes a flexible container or plastic bottle  122 . Threadably attached to the externally threaded neck  122   a  of the bottle  122  is a dispenser apparatus  124  according to an alternative embodiment of this invention. The dispenser apparatus  124  includes a cap portion  126  defining a collar portion  128  with internally formed (i.e., female) threads  130  for threadably engaging onto the threads of the neck  122 A of the bottle  122 . In this alternative embodiment, the cap portion  126  includes an end wall section  132 , including a tubular neck section  136  defining a through bore  138 . The bore portion  138  includes an inwardly tapering portion  138   a , leading to a slightly enlarged generally cylindrical section  138   b . An annular disk member  100  is received against the end wall  132 , and defines a slightly tapering sealing collar portion  134 , which is sealingly received inwardly of the neck  122 A of the bottle  122 . That is, this collar portion  134  sealingly cooperates with the bottle neck  122 A of the bottle  122 .  
      The disk member  100  cooperates with the wall  132  of the cap member  126  to define a pair of radially spaced radially extending and annular recesses  102 A and  102 B. Communicating with the inner one (i.e.,  102 A) of these annular recesses, the disk member  100  cooperates with the cap member  126  to define also a chamber  104  having a conical front wall section  138   c  (i.e., defined by a conical portion of the bore  138 ). In the annular recess  102 A, and captively received between the cap member  126  and the disk member  100  is a non-reversion resilient slit-valve member  170 . In contrast to the poppet valve type of construction used for the non-reversion valve  70 , the slit-valve member  170  employs a resilient disk  170 A defining at least one slit  170 B.  
      Movable received captively in the chamber  104  is a flow-responsive safety valve  90  having a poppet type of valve member  90 A confronting and sealingly engageable with the conical front wall section  138 C. Opposite to the front wall section  138 C, the valve member  90   a  defines a plurality of axially extending legs  90 B. These legs  90 B are engageable with an outer peripheral portion of the non-reversion valve member  170  and define flow path sections therebetween so that the safety valve member  90 A does not sealingly engage with the non-reversion valve member.  
      As is further seen particularly in  FIG. 7 , a splash guard member  148  is sealingly retained in the forward inwardly tapered portion  138 A of bore  138  by the sealing and retaining cooperation of an outwardly tapered stem portion  150  of the splash guard member  148 . At its inward distal end termination, this tapered stem portion  150  defines a crenellated end structure  150 A, defining plural flow path crenellations  150 B. As is seen in  FIG. 7 , when the splash guard member  148  is properly and fully inserted and sealingly seated at its stem portion  150  in the bore portion  138 A, then the crenellation feature  150 A engages against the safety valve member  90 A, keeping this valve member from engaging against the conical wall section  138 C. Accordingly, a flow path  180  is maintained through valve member  170  (which is pressure and flow responsive to open when the bottle  122  is squeezed with sufficient force), between the legs  90 B of the valve member  90 A, along chamber  104 , through the crenellations  150 B, and to the nozzle orifice  164 . Thus, as is seen in  FIG. 7 , a stream of cleansing liquid issues from the orifice  164  on nozzle protrusion  166  within the transparent splash shield portion  168 .  
      Now, when the user of the apparatus  110  relaxes manual squeezing on the bottle  122 , the resilient nature of the bottle itself results in a slight negative pressure being developed within the bottle  122 . However, this slight negative pressure is not sufficient to open the non-reversion slit-type valve  170 . Thus, back flow of contaminated liquid from the front surface of the splash shield  168  is substantially avoided. However, in order to provide for the bottle  122  to aspirate ambient air (which assists in further discharging cleansing liquid from the bottle  122  upon a subsequent squeezing of the bottle) the cap member  126  and disk member  100  each define respective ones of a plurality of vent passages  106 A and  106 B. And, within the annular recess  104 B a resilient annular disk valve member  108  is disposed to cover the passages  106 A. Thus, when the bottle  122  contains a negative (i.e., sub-ambient) pressure, as is seen in  FIG. 7A , the disk valve  108  is lifted slightly off the passages  106 A, and allows the bottle to aspirate ambient air. On the other hand, as is seen in  FIG. 7 , when the bottle  122  is being squeezed the disk valve  108  covers the passages  106 A, preventing cleansing liquid from being squeezed out of the vent passages. Thus, it is seen that the disk valve  108  serves as a check valve.  
      Viewing now  FIGS. 8 and 9 , and considering first  FIG. 8 , this Figure shows the apparatus  110  during a storage or shipping condition. That is, during storage and shipping, a closure member  90  covers the tubular portion  136 , and the opening of the bore  138 . In order to use the apparatus  110 , the user grasps an extending tang  90 A of the cap  90  and pulls to fracture the cap, thus ripping this cap off. The user then inserts the splash shield  148  as explained earlier in order to place the apparatus  110  in the use configuration. However, in the event that a user attempts to use the apparatus improperly and without the splash shield  148 , as is illustrated hypothetically in  FIG. 9 , then the safety valve  90  prevents such misuse. That is, the safety valve  90  is pressure and flow responsive, and engages sealingly upon the tapered wall section  138 C to prevent cleansing liquid outflow from the bottle  122 , as is seen in  FIG. 9 . Accordingly, the apparatus  110  cannot be used by the user until the splash shield  148  is properly installed.  
      The present invention is not limited to the embodiments described above, and it is to be understood that the invention is limited only by the spirit and scope of the appended claims, which provide a definition of the invention.