Abstract:
A medical device for use in connection with a connector of an indwelling line for cleansing a surface of a septum of the connector is provided. The medical device includes a housing including a proximal portion defining a cavity containing a quantity of microbial reducing agent, a distal portion defining a cavity for selective coupling with the connector of the indwelling line, and a partition separating the proximal and distal cavities, wherein the proximal and distal cavities are in fluid communication with one another; and a deformable member overlying an end of the proximal portion for maintaining the microbial reducing agent within the proximal cavity thereof. The microbial reducing agent being dispensable into the distal cavity, at least when the medical device is connected to the connector of the indwelling line, to awash a surface of the connector of the indwelling line and reduce microbes present thereon.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     The present application claims the benefit of U.S. Provisional Application No. 60/992,539, filed on Dec. 5, 2007, the entire content of which is incorporated herein by reference. 
    
    
     BACKGROUND 
     1. Technical Field 
     The present application relates to medical devices and, more particularly, to medical devices for use in connection with needleless connectors and the like for reducing the incidents of microbial contaminations on an external surface thereof. 
     2. Background of Related Art 
     Needleless connectors, commonly used with indwelling catheters, are typically accessed repeatedly by medical devices, such as, syringes, for the withdrawal of blood from a patient and/or the delivery/administration of medicaments to a patient. During entry of a syringe into a needleless connector, any microbes located on an external surface of the needleless connector, in particular on the access surface, may gain entry into the fluid path and then be introduced into the indwelling catheter, potentially resulting in bloodstream infections. Since conventional needleless connectors contain valve mechanisms that open a flow path upon connection of the syringe and close the flow path upon disconnection of the syringe, capping of needleless connectors between medical interventions is not commonplace. 
     As a result of these practices and in view of the concern for bloodstream infections, cleansing of the needleless connector prior to a medical intervention is recommended. The traditional cleansing method makes use of an alcohol swab which is wiped over the external access surface of the needleless connector. However, several factors, including a lack of convenience, lead to gaps in the usage of alcohol swabs and an increase in the potential for bloodstream infections. 
     Accordingly, a need exists for a more efficient system for reducing the potential of microbial contamination associated with needleless connectors. 
     SUMMARY 
     The present application relates to medical devices for use in connection with needleless connectors and the like for reducing the incidents of microbial contaminations on an external surface thereof. 
     According to an aspect of the present disclosure, a medical device for use in connection with a connector of an indwelling line is provided and includes a housing having a proximal portion and a distal portion separated from one another by a partition, wherein each of the proximal portion and the distal portion defines a respective proximal cavity and a distal cavity, wherein the proximal and distal cavities are in fluid communication with one another, and wherein the distal portion includes structure for selectively coupling with the connector of the indwelling line. The medical device further includes a microbial reducing agent disposed within the proximal cavity of the proximal portion; and a deformable member overlying an end of the proximal portion for maintaining the microbial reducing agent within the proximal cavity of the proximal portion. 
     The medical device may further include a valve member supported by the partition for enabling selective fluid communication between the proximal cavity and the distal cavity. The medical device may still further include an absorbent member disposed within the distal cavity. 
     The absorbent member may be dimensioned to contact the connector of the indwelling line when the medical device is connected thereto. The absorbent member may be in contact with the partition. The absorbent member may be axially slidably disposed within the distal cavity. 
     The medical device may further include a biasing member interposed between the partition and the absorbent member. The biasing member may maintain the absorbent member at a distal-most location. 
     The medical device may further include a backing member supporting the absorbent member. The backing member may be at least one of porous and permeable. 
     The absorbent member may be resilient. The absorbent member may contact an outer surface of the connector of the indwelling line when the medical device is connected to the connector of the indwelling line. The absorbent member may exert a mechanical cleansing action on at least a portion of the outer surface of the connector of the indwelling line upon a disconnection of the medical device from the connector of the indwelling line. 
     The microbial reducing agent may be transferable from the proximal cavity to the distal cavity upon exertion of a sufficient force on the deformable member. The microbial reducing agent may be transferred through the partition. The microbial reducing agent may be transferred through the valve member. The valve member may be a duck-bill valve. 
     The microbial reducing agent may be transferable to the absorbent member at least prior to an attachment of the medical device to the connector of the indwelling line and/or after an attachment of the medical device to the connector of the indwelling line. As such, the absorbent member may exert a chemical/biological and a mechanical cleansing action on an outer surface of the connector of the indwelling line upon at least connection and/or disconnection of the medical device to and/or from the connector of the indwelling line. 
     According to a further aspect of the present disclosure, a medical device for use in connection with a connector of an indwelling line for cleansing a surface of a septum of the connector is provided. The medical device includes a housing including a proximal portion defining a cavity containing a quantity of microbial reducing agent, a distal portion defining a cavity configured and dimensioned for selective coupling with the connector of the indwelling line, and a partition separating the proximal cavity and the distal cavity, wherein the proximal and distal cavities are in fluid communication with one another. The medical device further includes a deformable member overlying an end of the proximal portion for maintaining the microbial reducing agent within the proximal cavity of the proximal portion. In use, the microbial reducing agent is dispensable into the distal cavity, at least when the medical device is connected to the connector of the indwelling line, to awash a surface of the connector of the indwelling line and reduce microbes present thereon. 
     The medical device may further include an absorbent member disposed within the distal cavity. The absorbent member may be configured and dimensioned to contact the surface of the connector of the indwelling line when the medical device is connected thereto and to exert a mechanical cleansing action of the outer surface of the connector of the indwelling line when the medical device is at least connected to the connector of the indwelling line and/or disconnected from the connector of the indwelling line. 
    
    
     
       DETAILED DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a schematic, longitudinal, cross-sectional view of a medical device, for use with a needleless connector, according to an embodiment of the present disclosure, shown in a first, un-used and pre-connected condition; 
         FIG. 1B  is a schematic, longitudinal, cross-sectional view of the medical device of  FIG. 1 , shown connected to the needleless connector and in an un-used condition; 
         FIG. 1C  is a schematic, longitudinal, cross-sectional view of the medical device of  FIGS. 1A and 1B , shown in a primed condition; 
         FIG. 1D  is a schematic, longitudinal, cross-sectional view of the medical device of  FIGS. 1A-1C , shown in a used condition, disconnected from the needleless connector; 
         FIG. 2A  is a schematic, longitudinal, cross-sectional view of a medical device according to another embodiment of the present disclosure, shown disconnected from the needleless connector and in an un-used condition; 
         FIG. 2B  is a schematic, longitudinal, cross-sectional view of the medical device of  FIG. 2A , shown in a primed condition; 
         FIG. 3A  is a schematic, longitudinal, cross-sectional view of a medical device according to yet another embodiment of the present disclosure, shown connected to the needleless connector and in an un-used condition; 
         FIG. 3B  is a schematic, longitudinal, cross-sectional view of the medical device of  FIG. 3A , shown in a primed condition; 
         FIG. 4A  is a schematic, longitudinal, cross-sectional view of a medical device according to still another embodiment of the present disclosure, shown connected to the needleless connector and in an un-used condition; and 
         FIG. 4B  is a schematic, longitudinal, cross-sectional view of the medical device of  FIG. 4A , shown in a primed condition. 
     
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
     The following description is not intended to limit the claimed invention to the described embodiments and the disclosed combination of features in the various embodiments may not be absolutely necessary for the inventive solution. 
     Referring initially to  FIGS. 1A-1D , a medical device, for reducing the incidents of microbial contaminations on an external surface of a needleless connector  10 , is generally designated as  100 . As used herein, and as is common in the art, the term “distal” will refer to those elements located further from a user and the term “proximal” will refer to those elements located closer to a user. Unless otherwise specified, each of the devices disclosed herein will have a generally circular transverse cross-sectional profile. 
     In general, a needleless connector, such as needleless connector  10 , includes thickened septum  12  and a housing  14  to radially compress the septum  12  to thereby seal a slit  16  extending through the septum  12 . Alternatively, needleless connectors with any type of septum configuration known in the art, such as a generally solid septum, may be used. Accordingly, in use, when a male luer tip of a syringe (not shown) is pressed against an outer surface  18  of the septum  12  to open the slit  16 , an outer surface of the male luer tip disturbs the outer surface  18  of the septum  12 , thereby potentially carrying with it any microbes present on the outer surface  18  of the septum  12  into the connector  10  (i.e., beyond the septum  12 ). 
     As seen in  FIGS. 1A-1D , medical device  100  includes a housing  110  having a proximal end  112  and a distal end  114  separated from one another by a partition  116 . Proximal end  112  defines a cavity or chamber  112   a  having an open proximal end  112   b  that is covered by a deformable member in the form of an impermeable membrane  118  or the like. It is contemplated that other configurations for proximal end  112  may be used, such as, for example, a closed configuration having at least one domed surface or deformable member located along the length of proximal end  112  and unitarily formed with housing  110 . It is further contemplated that at least a portion of the wall thickness of the at least one domed surface or deformable member may be thinner than the adjacent structure of housing  110  which would facilitate the collapsing of the domed structure. 
     A microbial reducing agent “MRA” in liquid or gel form is retained within proximal cavity  112   a . Suitable microbial reducing agents include and are not limited to alcohol, povidone iodine, ethylenediaminetetraacetic acid (EDTA), or any other agent or any combination of agents typically used for cleansing medical devices and/or inhibiting microbial contamination thereon. A sufficient quantity of microbial reducing agent “MRA” is retained within proximal cavity  112   a  such that membrane  118  projects from medical device  100  when medical device  100  is new and/or un-used. 
     Distal end  114  defines a cavity or chamber  114   a  having an open distal end  114   b  and being configured and dimensioned to selectively receive and engage needleless connector  100 . Distal end  114  includes a coupling member  114   c  formed on or in an inner surface thereof for selectively engaging a complementary coupling member  14   a  provided on or in housing  14  of needleless connector  10 . Coupling member  114   c  may include and is not limited to a helical thread, a bayonet-type connector, or any other suitable formation capable of establishing a mechanical connection between medical device  100  and housing  14  of needleless connector  10 . 
     Partition  116  defines at least one opening  116   a  therein for fluidly interconnecting proximal cavity  112   a  and distal cavity  114   a . Medical device  100  includes a valve member  120  disposed within each opening  116   a . Valve member  120  may be a unidirectional valve, such as, for example, a duckbill valve, which allows for fluid flow in substantially a single direction from proximal cavity  112   a  to distal cavity  114   a . It is contemplated that other types of valve members may be used, such as, for example, bi-direction valves which allow for fluid flow between proximal cavity  112   a  and distal cavity  114   a . It is further contemplated that any element capable of maintaining the microbial reducing agent “MRA” within proximal cavity  112   a  and selectively releasing the microbial reducing agent “MRA” from within proximal cavity  112   a  may be used to occlude each opening  116   a , such as, for example, a breakthrough seal or the like. When medical device  100  is new and/or un-used, valve member  120  maintains substantially all of the microbial reducing agent “MRA” within proximal cavity  112   a.    
     Medical device  100  further includes an absorbent member  122 , such as, for example, a sponge, a pad or the like disposed within distal cavity  114   a  of distal portion  114 . Absorbent member  122  may be supported on a backing member  124  or the like. Backing member  124  may be porous, permeable or, alternatively, may include at least one aperture  124   a  formed therethrough. It is contemplated that apertures  124   a  may extend at least partially or completely through absorbent member  124  to more directly “wet out” the surface of septum  12 . 
     A biasing member  126  may be interposed between partition  116  and absorbent member  122  for maintaining absorbent member  122  at a distal-most position within distal cavity  114   a  of distal end  114  when medical device  100  is not connected to needleless connector  10 . 
     With continued reference to  FIGS. 1A-1D , a method of using medical device  100  is provided below. In use, upon completion of a medical intervention, distal portion  114  of medical device  100  is connected to needleless connector  10 . Medical device  100  remains connected to needleless connector  10  via the inter-engagement of respective coupling members  114   c  and  14   a.    
     As seen in  FIG. 1B , as medical device  100  is coupled to needleless connector  10 , outer surface  18  of septum  12  thereof contacts and presses against absorbent member  122 . Additionally, as medical device  100  is fully and/or completely coupled to needleless connector  10 , biasing member  126  becomes compressed within distal cavity  114   a  and thus creates an increasing frictional force between absorbent member  122  and outer surface  18  of septum  12 . 
     In use, prior to a subsequent medical intervention, as seen in  FIG. 1C , membrane  118  is pressed, in the direction of arrow “A”, to create a fluid pressure within proximal cavity  112   a  of proximal portion  112 . In so doing, the pressure increase causes valve member  120  to open, releasing microbial reducing agent “MRA” into distal cavity  114   a.    
     It is contemplated that an indicator window (not shown) may be provided in distal portion  114  to provide the user with a visual indication that the microbial reducing agent “MRA” has been pressed or squeezed into distal cavity  114   a . Alternatively, housing  110  may be partially or completely formed of a transparent or translucent material enabling a user to visually notice the release of the microbial reducing agent “MRA” into distal cavity  114   a.    
     As the microbial reducing agent “MRA” is released into distal cavity  114   a  of distal portion  114 , the microbial reducing agent “MRA” is directly absorbed into absorbing member  122  or passed through backing member  124  and then into absorbing member  122  as well as transported through at least one aperture  124   a  to directly contact outer surface  18  of septum  12 . As the microbial reducing agent “MRA” is absorbed into the absorbing member  122  the microbial reducing agent “MRA” further comes into contact with outer surface  18  of septum  12  exerting a chemical/biological cleansing action thereon and thus reducing any microbial contamination that may exist on outer surface  18  of septum  12 . 
     Any air present in distal cavity  114   a , during the pressing of membrane  118 , may be vented through the coupling members  14   a  and  114   c . In this manner, filling of distal cavity  114   a  with the microbial reducing agent “MRA” is facilitated. Alternatively, venting may be provided through a vent or port (not shown) formed in distal portion  114 . 
     In order to further reduce the potential existence of microbial contaminants on the outer surface  18  of septum  12 , an appropriate period of time, commensurate in scope with the type of microbial reducing agent “MRA” being used, is permitted to lapse prior to the removal of medical device  100  from needleless connector  10 . Additionally, the microbial reducing agent “MRA” may be released into distal cavity  114   a  of distal portion  114  immediately following the connection of medical device  100  to needleless connector  10  to achieve an instantaneous microbial reducing environment for outer surface  18  of septum  12 . In this manner, medical device  100  provides further prevention of microbial contamination of septum  12  throughout the period of time in between medical interventions. 
     In operation, as seen in  FIG. 1D , as medical device  100  is removed or disconnected from needleless connector  10 , for example, as by rotation, biasing member  126  maintains absorbent member  122  in contact with outer surface  18  of septum  12 . In so doing, the rotation of medical device  100  relative to needleless connector  10  and, in particular, the outer surface  18  of septum  12 , imparts a mechanical cleansing action by the absorbent member  122  against the outer surface  18  of septum  12 . 
     Once medical device  100  has been completely removed or disconnected from needleless connector  10 , medical device  100  may be appropriately discarded. 
     Turning now to  FIGS. 2A-2B , a medical device, according to another embodiment of the present disclosure, is generally designated as  200 . Medical device  200  is substantially similar to medical device  100  and thus will only be discussed in detail herein to the extent necessary to identify differences in construction and operation thereof. 
     As seen in  FIGS. 2A-2B , medical device  200  does not include a biasing member interposed between partition  216  and absorbent member  222 , in the manner of medical device  100 . Instead, medical device  200  includes a resilient absorbent member  222  disposed within distal cavity  214   a  of distal portion  214 . It is contemplated that absorbent member  222  may be relatively thicker than absorbent member  122  and may include at least one aperture formed therethrough (not shown). 
     In use, as medical device  200  is connected to needleless connector  10 , absorbent member  222  is compressed, as seen in  FIG. 2B . Prior to accessing needleless connector  10 , membrane  218  is pressed, thus expelling the microbial reducing agent “MRA” from proximal cavity  212   a , through valve member  220 , into absorbent member  222  disposed within distal cavity  214   a . As the microbial reducing agent “MRA” is absorbed into the absorbing member  222  the microbial reducing agent “MRA” comes into contact with outer surface  18  of septum  12  exerting a chemical/biological cleansing action thereon and thus reducing any microbial contamination that may exist on outer surface  18  of septum  12 . 
     In operation, similar to medical device  100 , as medical device  200  is removed or disconnected from needleless connector  10 , for example, as by rotation, the resiliency of absorbent member  222  helps to maintain absorbent member  222  in contact with outer surface  18  of septum  12  as absorbent member  222  expands upon the disconnection of medical device  200  from needleless connector  10 . In so doing, the rotation of medical device  200  relative to needleless connector  10  and, in particular, the outer surface  18  of septum  12 , imparts a mechanical cleansing action by the absorbent member  222  against the outer surface  18  of septum  12 . 
     Turning now to  FIGS. 3A-3B , a medical device, according to another embodiment of the present disclosure, is generally designated as  300 . Medical device  300  is substantially similar to medical devices  100  or  200  and thus will only be discussed in detail herein to the extent necessary to identify differences in construction and operation thereof. 
     As seen in  FIGS. 3A-3B , medical device  300  does not include a biasing member interposed or an absorbent member disposed within a distal cavity  314   a  of distal portion  314  thereof, in the manner of medical device  100 . Instead, distal cavity  314   a  of medical device  300  is an open and/or empty cavity. 
     In use, prior to accessing needleless connector  10 , membrane  318  is pressed, thus expelling the microbial reducing agent “MRA” from proximal cavity  312   a , through valve member  320 , into distal cavity  314   a . As the microbial reducing agent “MRA” is expressed into distal cavity  314   a  the microbial reducing agent “MRA” comes into contact with outer surface  18  of septum  12  exerting a chemical/biological cleansing action thereon and thus reducing any microbial contamination that may exist on outer surface  18  of septum  12 . 
     Turning now to  FIGS. 4A-4B , a medical device, according to another embodiment of the present disclosure, is generally designated as  400 . Medical device  400  is substantially similar to medical device  200  and thus will only be discussed in detail herein to the extent necessary to identify differences in construction and operation thereof. 
     As seen in  FIGS. 4A-4B , medical device  400  includes an absorbent member  422  disposed within distal cavity  414   a  and in contact with partition  416 . It is contemplated that absorbent member  422  may be dimensioned such that absorbent member  422  does not contact outer surface  18  of septum  12  when medical device  400  is connected to needleless connector  10 . Absorbent member  422  functions to direct the initial amount of microbial reducing agent “MRA” to outer surface  18  of septum  12  as well as to minimize the amount of microbial reducing agent “MRA” that may exit distal cavity  414   a  upon the disconnection of medical device  400  from needleless connector  10 . 
     In use, prior to accessing needleless connector  10 , membrane  418  is pressed, thus expelling the microbial reducing agent “MRA” from proximal cavity  412   a , through valve member  420 , into distal cavity  414   a . As the microbial reducing agent “MRA” is expressed into distal cavity  414   a  some microbial reducing agent “MRA” is absorbed into absorbent member  422  and some microbial reducing agent “MRA” comes into contact with outer surface  18  of septum  12  exerting a chemical/biological cleansing action thereon and thus reducing any microbial contamination that may exist on outer surface  18  of septum  12 . 
     As medical device  400  is removed or disconnected from needleless connector  10 , some microbial reducing agent “MRA” remains absorbed in absorbent member  422  and thus relatively less microbial reducing agent “MRA” is spilled. 
     While chemical/biological and/or mechanical cleansing actions have been described during the disconnection of the medical devices from the needleless connectors, it is contemplated and within the scope of the present disclosure that the absorbent members may be pre-soaked with microbial reducing agent “MRA” prior to connection of the medical device to the needleless connectors. In this manner, a chemical/biological and/or mechanical cleansing action of the outer surface of the septum of the needleless connector may take place upon either the connection of the medical device to the needleless connector or the disconnection of the medical device from the needleless connector due to the frictional engagement of the absorbent member against the outer surface of the needleless connector. 
     It will be understood that the embodiments of the present disclosure which have been described are illustrative of some of the applications of the principles of the present invention. Various modifications may be made by those skilled in the art without departing from the true spirit and scope of the invention.