Abstract:
A luer cleaner ( 100 ) including a generally hollow body ( 112 ) having an open first end ( 104 ), a closed second end ( 106 ), and a longitudinal axis extending therethrough between the first end and the second end. The first end ( 104 ) is sized to receive therein a luer connector ( 190 ) proximal end and includes a plurality of bristles ( 134 ) extending generally toward the longitudinal axis sufficiently to engage the outer surfaces of the luer proximal end disposed therein. The second end comprises a compressible reservoir ( 166 ) containing a fluid ( 168 ), wherein, when the second end is compressed, the fluid is transmitted from the reservoir toward the first end through passageways to wet the luer proximal end. A method for cleaning luer connectors is also disclosed.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This relates to and claims priority from Provisional U.S. Patent Application Ser. No. 60/587,790 filed Jul. 14, 2004. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to medical device, and more particularly to an apparatus for cleaning a luer connector that is attached to a catheter assembly implanted on a patient. 
     BACKGROUND OF THE INVENTION 
     In catheter assemblies such as are used in hemodialysis, proximal ends of the catheters are terminated in luer connectors that are disposed outside of the patient, and the luer connectors enable easy and rapid connection to respective fluid lines of the hemodialysis apparatus in a manner permitting easy and rapid disconnect. Of course, when unconnected to the fluid lines, the ends of the luer connectors are exposed to debris and contamination and they require cleaning and decontamination prior to each connection. 
     SUMMARY OF THE INVENTION 
     The present invention is a cleaner for a medical device such as a luer connector, or luer, that includes a generally hollow body having an open first end, a closed second end, and a longitudinal axis extending therethrough between the first end and the second end. The first end is sized to receive therein the proximal end of the luer connector, and includes a scrubber to engage the luer connector disposed therein. The second end comprises a compressible reservoir containing a fluid, wherein, when the second end is compressed, the fluid is transmitted from the reservoir toward the first end. When the luer cleaner is inserted over the proximal end of the luer connector and preferably is rotated reciprocally several times about the luer&#39;s axis, the scrubber engages and mildly scrubs the outer surfaces of the luer&#39;s proximal end, including the male connector threads, to dislodge debris, and the fluid washes and thus cleans and decontaminates the luer connector end when the luer cleaner is removed from the luer connector. Preferably, the scrubber includes a plurality of generally pointed flexible projections or bristles, extending generally radially inwardly toward the longitudinal axis sufficiently to engage the luer. The scrubber may comprise at least one disc, or preferably a plurality of discs, each having a plurality of flexible projections or bristles on a ring thereof. 
     The present invention further includes a scrubber having a peripheral body and a plurality of flexible generally pointed projections extending radially inwardly therefrom, to engage outer surfaces of a medical device inserted therethrough. Even further, the present invention includes a cleaner for a medical device including a hollow body containing one or more scrubbers each having flexible projections extending radially inwardly to engage and scrub outer surfaces of a medical device inserted into the hollow body. 
     The method of the present invention includes: inserting a luer proximal end into a luer cleaner open end so that a scrubber within the luer cleaner engages the luer proximal end outer surfaces to scrub them; compressing the luer cleaner&#39;s closed second end to force fluid toward the open first end through passageways to wash the luer&#39;s proximal end. The method preferably includes the step of rotating or reciprocally rotating the luer cleaner about the thus-inserted luer to scrub and clean it. 
     Other embodiments of the luer cleaner provide a frangible capsule within the reservoir at the second luer cleaner end that contains the fluid and that expresses the fluid when crushed; and provide a pair of frangible capsules within the reservoir, that contain the fluid and together express the fluid. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings: 
         FIG. 1  is a perspective view of a luer cleaner according to a first preferred embodiment of the present invention, with a luer being inserted into the luer cleaner; 
         FIG. 2  is an exploded view of the luer cleaner shown in  FIG. 1 ; 
         FIG. 3  is a sectional view of the luer cleaner shown in  FIG. 1 ; 
         FIG. 4  is an enlarged front view of a scrubber disc shown inside the luer cleaner; 
         FIG. 5  is a sectional view of the scrubber disc of  FIG. 4 , taken along line  5 - 5  of  FIG. 4 ; and 
         FIGS. 6 and 7  are sectional views of luer cleaners according to second and third embodiments of the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The words “proximal” and “distal” refer to directions away from and closer to, respectively, the inserted portion of the catheter assembly within the patient&#39;s vasculature. The terminology includes words specifically mentioned, derivatives thereof, and words of similar import. The following describes preferred embodiments of the invention. However, it should be understood based on this disclosure that the invention is not limited by the preferred embodiments described herein. 
     Referring now to  FIG. 1 , a luer cleaner  100  according to a first embodiment of the present invention is shown. The luer cleaner  100  is insertable over the proximal end of a luer connector  190  and rotatable axially about the luer. Luer connector, or luer,  190  is preferably connected to a medical device, such as a hemodialysis catheter  194 . The proximal end of luer  190  includes male threads  192  that are used to secure luer  190  to a second medical device (e.g., a hemodialysis apparatus) having fluid lines each terminating in a corresponding luer connector that incorporates internal female threads. Prior to connection of the luer  190  with the second medical device, the proximal end of luer  190  is inserted into an open end of the luer cleaner  100 . As the luer cleaner  100  is rotated about the luer  190 , antiseptic fluid contained in the luer cleaner  100  is forced from a reservoir in the luer cleaner  100  such as by manually applied pressure, over the luer  190 , to clean debris and other contaminants that may be present on or around the luer threads  192 . Also shown, along with  FIGS. 2 and 3 , is a body  160  defining a reservoir  166  for a fluid  168 . 
     Referring now to  FIGS. 2 and 3 , the luer cleaner  100  includes an open end  104 , a closed end  106 , and a longitudinal axis  107  extending therethrough between the open end  104  and the closed end  106 . The open end  104  includes a generally tubular body  108  having a longitudinal passage  110  that extends toward the closed end  106 . Preferably, the body  108  is constructed from polyvinyl chloride or some other suitable biocompatible material. The body  108  includes an exterior portion  112  that may optionally include a plurality of gripping ribs  114  extending therefrom, away from the longitudinal axis  107 . The gripping ribs  114  allow a user to grip the body  108  during use of the cleaner  100 . The interior of the body  108  includes at least one, and preferably two, diametrically opposed alignment notches  116  that extend from the longitudinal passage  110  away from the longitudinal axis  107 . 
     The body  108  further includes a guide member  117  that extends partially into the longitudinal passage  110  along the longitudinal axis  107  toward the open end  104 . The guide member  117  preferably includes a male luer taper  118  to engage a female luer connection on the luer  190 . The guide member  117  prevents fluid from entering the catheter  194  through the interior of the luer  190  after the fluid has been forced into the longitudinal passage  110  from the reservoir. The guide member  117  is preferably integrally molded with the body  108 , as seen in the cross-section view of  FIG. 3 . 
     At least one and preferably four passages  119  are disposed within the body  108  between the exterior portion  112  of the body  108  and the guide member  117  (although only two passages  119  are shown in  FIG. 3 ). The passages  119  are preferably parallel to the longitudinal axis  107  and each passage  119  is disposed ninety degrees apart from each adjacent passage  119 . 
     The body  108  also includes an annular flange  120  that extends from the body  108 , away from the open end  104  of the luer cleaner  100 . The flange  120  extends outwardly of the passages  119 , with a lip  122  being formed between the flange  120  and the exterior portion  112  of the body  108 . 
     A tubular collar  123 , having an approximately “T-shaped” cross section, is fixedly connected to the body  108 , distal from the open end  104  of the luer connector  100 . The collar  123  includes a corresponding lip  124  that extends circumferentially therearound and that is sized to surround and engage with the flange  120  of the body  108 , as is seen in  FIG. 3 . The connection between the collar  123  and the body  108  may be an interference fit, a threaded connection, an adhesive-based connection, or some other suitable connection known to those skilled in the art. 
     The collar  123  also includes a connecting passage  125  that extends through the collar  123 , generally along the longitudinal axis  107 , with the connecting passage having a small diameter, as seen in  FIG. 3 . When the collar  123  and the body  108  are engaged with each other, a generally circular throughway  126  is formed between the body  108  and the collar  123  that provides fluid communication between the connecting passage  125  and the very small diameter passages  119  in the body  108 . 
     A scrubber  130  is disposed within the longitudinal passage  110  and is preferably constructed from at least one, and preferably a plurality, of scrubber discs  131 . Details of a scrubber disc  131  are shown in  FIGS. 4 and 5 ; each scrubber disc  131  includes an annular ring  132 , with each ring  132  having a plurality of flexible generally pointed projections or scrubber bristles  134  extending radially inwardly therefrom toward the longitudinal axis  107 . Preferably, the rings  132  and flexible projections  134  are constructed from polypropylene or some other suitable biocompatible material, and are non-abrasive to mildly scrub the luer surfaces. The flexible projections  134  extend sufficiently far toward the center of each ring  132  so as to engage the luer threads of the luer when the luer is inserted into the luer cleaner  100 . As seen in  FIG. 3 , the guide member  117 , which also is referred to herein as a centering post, extends longitudinally within a channel  133  defined by the scrubber  130  at the end of the projections  134 . 
     Preferably, the ring  132  for each scrubber disc  131  includes at least one, and preferably two diametrically opposed, alignment posts  136  that extend from the outer perimeter of the ring  132  away from the center of the ring  132 . Each post  136  is sized and shaped to fit into a respective alignment notch  116  cut into the body  108 . Each post  136  engages the alignment notch  116  in a generally tight, frictional fit so that each ring  132  remains within the longitudinal passage  110  after insertion thereinto. 
     Each ring  132  also includes at least one, and preferably, a plurality of through-passages  140  that allow fluid to pass from one side of each ring  132  to an opposing side of each ring  132 . Four through-passages  140  are preferred, as shown in  FIG. 4 , with each through-passage  140  being disposed at ninety-degree spacings from each adjacent through-passage  140 , although those skilled in the art will recognize that more or less than four through-passages  140  may be used. However, it is preferred that each through-passage  140  fluidly communicates with a passage  119  in the body  108 , so that fluid communication exists between all of the passages  140  and the connecting passage  125 . 
     Further, a plurality of radially extending channels  142  extends along transverse surfaces of each ring  132  from the outer perimeter of the ring  132  to the inner diameter of the ring  132 , with each channel  142  fluidly communicating with a through-passage  140 . As can be discerned from  FIGS. 4 and 5 , four channels  142  are disposed at ninety-degree spacings apart from each adjacent channel  142 , with channels  142  disposed on either side of each ring  132 , although those skilled in the art will recognize that, for each through-passage  140 , a channel  142  is preferably disposed on either face of the ring  132 . 
     With a plurality of rings  132  disposed adjacent one another, as shown in  FIG. 3 , the radially extending channels in adjacent rings  132  form radial passages  146  that provide fluid communication between each through-passage  140  and the longitudinal passage  110  to allow fluid to be transmitted through the radial passages  146  to the longitudinal passage  110 . Fluid communication is now present between the longitudinal passage  110  and the connector passage  125 . 
     Again referring to  FIG. 3 , sealing ring  150  is disposed between the array of rings  132  and the open end  104  of the luer cleaner  100 . The sealing ring  150  preferably has an internal diameter that is approximately the same as the external diameter of the luer  190  (see  FIG. 1 ) to prevent fluid forced manually from the reservoir  168  within bulbous body  160  and into the longitudinal passage  110 , from flowing out of the luer cleaner  100  between the luer and the body  108  of the cleaner  100 . The sealing ring  150  is preferably constructed from KRATON™ or other suitable, flexible material, so that the sealing ring  150  generally provides a seal around the luer when the luer is inserted into the luer cleaner  100 . 
     A cap  152  is disposed on the open end  104  of the luer cleaner  100  to retain the sealing ring  150  and the array of scrubber rings  132  within the luer cleaner  100 . The cap  152  is preferably annular, with a generally circular central opening  154  that is sized to allow the luer to be inserted therethrough. The cap  152  is preferably fixedly connected to the body  108 , such as with an adhesive, although those skilled in the art will recognize that the cap  152  may be retained by other methods, such as by interference fit, or a threaded connection. 
     The closed end  106  of the luer cleaner  100  includes a generally bulbous body  160  constructed from KRATON™, 1064 PVC, or some other suitable, compressible material. The body  160  includes an open end  162  that is fixedly and sealingly connected to the collar  123  and a closed end  164  disposed away from the open end  162 . The interior of the bulbous body  160  defines a compressible reservoir  166 . A fluid  168  is disposed within the reservoir  166  such that the reservoir  166  fluidly communicates with the longitudinal passage  110  of the generally tubular body  108  through the connecting passage  125 , the circular throughway  126 , the passages  119 , the through-passages  140 , and the radial passages  146 . 
     Preferably, the fluid  168  is a fluid having antiseptic properties, such as alcohol. More preferably, the fluid  168  is sufficiently viscous to remain in the reservoir  166  in the absence of a compressive force on the body  160  of the reservoir  166 , considering the small diameter of connecting passage  125 . Such a preferred fluid  168  is isopropyl alcohol in a polymer suspension, such as polyvinyl alcohol, sold commercially by GOJO Industries as PURELL®, although those skilled in the art will recognize that other fluids, including, but not limited to, povodine iodine or hydrogen peroxide, or any combination thereof, may be used instead. 
     In use, and referring to  FIGS. 1 and 3 , the luer  190 , such as on a proximal end of a catheter  194 , is inserted into the open end  104  of the luer cleaner  100 . The sealing ring  150  engages the external portion of the luer  190 , restricting fluid  166  from being forced out of the open end  104  of the luer cleaner  100 . 
     After the luer  190  is fully inserted into the open end  104  of the luer cleaner  100 , the bulbous body  160  is then compressed, forcing the fluid  168  in the reservoir  166  from the reservoir  166  and eventually into the longitudinal passage  110  of the generally tubular body  108  by way of being forced through the connecting passage  125 , the circular throughway  126 , the passages  119 , the through-passages  140 , and the radial passages  146 , to the longitudinal passage  110  and thus to the exterior of the luer  190 . The luer  190  is rotated about the longitudinal axis  107  of the luer cleaner  100 , in a preferably back-and-forth motion, so that the bristles  134  on the scrubber discs  131 , in conjunction with the fluid  168 , clean contaminants from the exterior of the luer  190 , including the luer threads  192 . After several seconds of scrubbing, the luer is removed from the luer cleaner  100 , and the luer cleaner  100  may be discarded. Luer  190  is now disinfected and may be connected to an external medical device. 
     In an alternate embodiment of a luer cleaner  200 , shown in  FIG. 6 , a fluid  268  may be retained in a frangible container  270  disposed within the reservoir  166 . The fluid  268  may be significantly less viscous than the fluid  168  described above with respect to the luer cleaner  100  ( FIG. 1 ). The frangible container  270  prevents the fluid  268  from flowing out of the reservoir  166  prior to use. 
     To use the luer cleaner  200 , the luer is inserted into the open end  104  as described above with respect to the luer cleaner  100 . The user compresses the reservoir  166  toward the longitudinal axis  107 , breaking the frangible container  270 , and allowing the fluid  268  to flow from the reservoir  166  and to the longitudinal passage  110  as described above with respect to the luer cleaner  100 . 
     The frangible container  270  may be constructed from a material that is easily broken open under compression. The fluid  268  may be the same as the fluid  168  described above, or the fluid  268  may be a less viscous fluid, such as, for example, isopropyl alcohol without any suspension. 
     In  FIG. 7 , a third embodiment of luer cleaner  300  is shown. A pair of frangible containers  370  are secured to opposite sides of a tab  372 , each containing quantities of fluid  368  that will be expressed into and forwardly through channel  376  of tab  372 , as with the other luer cleaner embodiments. Luer cleaner  300  preferably provides visible indicators such as raised areas  374  on opposed outside surfaces of closed end  360  associated with respective ones of frangible containers  370 , to enable the user to compress those indicated surfaces toward each other to crush the frangible containers  370  against tab  372 , thus opening them for fluid  368  to enter tab channel  376  and forwardly into passageways of the luer cleaner open end. 
     It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.