Patent Publication Number: US-2021162194-A1

Title: Antiseptic cap

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 16/162,106, filed Oct. 16, 2018, which is a continuation of U.S. patent application Ser. No. 13/803,289, filed on Mar. 14, 2013, now U.S. Pat. No. 10,166,381, which is a continuation-in-part of U.S. patent application Ser. No. 13/113,777, filed on May 23, 2011, now U.S. Pat. No. 9,867,975, the entire disclosure of each of which is expressly incorporated herein by reference. 
    
    
     BACKGROUND 
     Technical Field 
     The present invention relates to an antiseptic cap, and more particularly, to an antiseptic dead-end cap for a medical connector. 
     Background Art 
     Catheters are widely used to treat patients requiring a variety of medical procedures. Catheters can either be acute, or temporary, for short-term use or chronic for long-term treatment. Catheters are commonly introduced into central veins (such as the vena cava) from peripheral vein sites to provide access to a patient&#39;s vascular system. 
     In an IV dispensing system, a luer connector, e.g., a male luer connector, can have a first end and a second end. The first end of the male luer connector can be connected to a fluid line that is connected to a fluid source, such as an IV bag filled with fluid. The second end of the male luer connector can be removably attached to a first end of a female needleless luer connector. The second end of the female needleless luer connector can be attached to a catheter that has been introduced into a patient. 
     When the male luer connector and the female needleless luer connector are attached to each other, fluid from the IV bag can flow into the patient. These connectors are often separated from each other at various times, for example, when a patient needs to use restroom facilities. When the connectors are disengaged from each other, the connectors are exposed and are prone to contamination. Current procedures to reduce contamination of the connectors involve swabbing the connectors with a disinfection. These procedures are prone to human error and are often not implemented. Furthermore, when a male luer connector is disengaged from a female needleless connector, there is no standard manner in which to store and protect the male luer connector until it is reattached to the female connector. 
     SUMMARY 
     The present invention relates to an antiseptic dead-end cap for use with a connector that includes a base having first and second sides, a first annular wall extending from the first side of the base, a cylindrical center plug extending from the first side of the base, and a second annular wall extending from the second side of the base. The first annular wall has an outer surface and an inner surface. The cylindrical center plug has an outer surface and an inner surface, and is positioned within the first annular wall to form an annular chamber. The second annular wall has an outer surface and an inner surface, and defines a second chamber having an open end. An antiseptic material is on at least one of the inner surface of the first annular wall, the inner surface of the second annular wall, the outer surface of the second annular wall, and the outer surface of the cylindrical center plug. 
     The present invention further relates to an antiseptic dead-end cap for use with a connector that includes a base having first and second sides, a male connector portion extending from the first side of the base and configured to be connectable to a female luer, and a female connector portion extending from the second side of the base and configured to be connectable to a male luer. An antiseptic material is on at least a portion of the male luer connector portion or the female luer connector portion. 
     In some aspects, the male connector portion includes a first annular wall extending from the first side of the base and having an outer surface and an inner surface, and a cylindrical center plug extending from the first side of the base. The cylindrical center plug has an outer surface and an inner surface, and is positioned within the first annular wall to form an annular chamber. In such aspects, the female connector portion includes a second annular wall extending from the second side of the base, has an outer surface and an inner surface, and defines a second chamber having an open end. 
     In some aspects, the antiseptic material is a metal, while in other aspects, the antiseptic material can be an alcohol. 
     In other aspects, the first annular wall includes one or more threads. In still another aspect, the second annular wall includes one or more threads. 
     In yet another aspect, the antiseptic material is formed in at least one of the inner surface of the first annular wall, the inner surface of the second annular wall, the outer surface of the second annular wall, and the outer surface of the cylindrical center plug. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a more complete understanding of the present invention, reference is made to the following Detailed Description of the Invention, considered in conjunction with the accompanying drawings, in which: 
         FIG. 1  is a cross-sectional view of an antiseptic cap assembly engaged to a luer connector according to the present invention; 
         FIG. 2  is a perspective view of a sealed antiseptic cap assembly; 
         FIG. 3  is an exploded perspective view showing the antiseptic cap assembly of  FIG. 1  and a luer connector; 
         FIG. 4  is a perspective view of the antiseptic cap assembly of  FIG. 1  engaged to a luer connector; 
         FIG. 5  is a cross-sectional view showing an antiseptic cap assembly, wherein a cap has an outer wall; 
         FIG. 6  is a cross-sectional view showing an antiseptic cap assembly, wherein the cap includes a center insert; 
         FIG. 7  is a cross-sectional view showing an antiseptic cap assembly, wherein the cap includes a center plug; 
         FIG. 8  is a cross-sectional view showing an antiseptic cap assembly, wherein a cap holder includes an inner-facing flange; 
         FIG. 9  is a cross-sectional view showing an antiseptic cap assembly, wherein a center plug is provided and the cap holder includes an inner-facing flange; 
         FIG. 10  is a cross-sectional view showing an antiseptic cap assembly, wherein a cap includes an annular portion without threads; 
         FIG. 11  is a cross-sectional view showing an antiseptic cap assembly that includes an antiseptic chamber; 
         FIG. 12  is a perspective view of the antiseptic cap assembly shown in  FIG. 11 ; 
         FIG. 13  is a perspective view showing an antiseptic cap assembly, wherein a cap holder includes retainers; 
         FIG. 14  is a cross-sectional view, taken along section lines  14 - 14  and looking in the direction of the arrows, of the antiseptic cap assembly shown in  FIG. 13 ; 
         FIG. 15  is a cross-sectional view, taken along section lines  15 - 15 , of the antiseptic cap assembly shown in  FIG. 13 ; 
         FIG. 16  is a cross-sectional view showing an antiseptic cap assembly that includes a ratchet assembly; 
         FIG. 17  is an exploded view of the antiseptic cap assembly shown in  FIG. 16  and a luer connector; 
         FIG. 18  is a partially cut away perspective view of the antiseptic cap assembly shown in  FIG. 16  showing the ratchet assembly; 
         FIG. 19  is a perspective view showing an antiseptic cap assembly without a cap holder; 
         FIG. 20  is a cross-sectional view showing the antiseptic cap assembly of  FIG. 19  having hydrophobic and hydrophilic sections; 
         FIG. 21  is a perspective view showing an antiseptic cap assembly, wherein a cap holder has a flange with a recess for receiving a line; 
         FIG. 22  is a cross-sectional view showing an antiseptic cap assembly, wherein a plug is supported by an arm; 
         FIGS. 23-27  are perspective views showing an antiseptic cap assembly with various fastening mechanisms; 
         FIG. 28  is a perspective view of an antiseptic dead-end cap; 
         FIG. 29  is a front view of the antiseptic dead-end cap; 
         FIG. 30  is a side view of the antiseptic dead-end cap; 
         FIG. 31  is another perspective view of the antiseptic dead-end cap; 
         FIG. 32  is another perspective view of the antiseptic dead-end cap; and 
         FIG. 33  is a cross-sectional view of the antiseptic dead-end cap of  FIG. 28  taken along line  33 - 33 . 
     
    
    
     DETAILED DESCRIPTION 
     The present invention relates to an antiseptic cap assembly that engages a male end of a luer connector. It should be understood, however, that the teachings herein can be used with other types of medical connectors. 
       FIG. 1  is a cross-sectional view of an antiseptic cap assembly  10  engaged to a luer connector  12 . A proximal end  14  of the luer connector  12  is attached to a fluid line  16  which is connected to a fluid source (not shown), such as a IV bag filled with fluid. The luer connector  12  includes an annular threaded portion  18  with internal threads  20  and a frustoconical male luer  22  positioned for insertion into a female luer connector (not shown). The male luer  22  includes a tip  26  having an opening  24  in fluid communication with the fluid line  16 . The male luer  22  is arranged substantially concentrically within the threaded portion  18 . As a result of their generally coaxial arrangement, the male luer  22  and the threaded portion  18  cooperate to form an annular space therebetween. 
     The antiseptic cap assembly  10  includes a cap holder  28  and a cap  30  sized to be positioned within the cap holder  28 . The cap  30  includes a base  32  and an annular threaded portion  34  extending from the base  32 . The base  32  could include a substantially flat surface  36  and an outer flange  38 . 
     The threaded portion  34  of the cap  30  includes a rim  40  that defines an open end  42  (see  FIG. 3 ). The base  32  closes the opposite end of the threaded portion  34 . The threaded portion  34  could be formed with a tapered inner surface  46  that compliments the male luer  22  of the luer connector  12 . In particular, the tapered inner surface  46  narrows from the rim  40  toward the base  32 . The threaded portion  34  defines a chamber  48  (see  FIG. 3 ) sized to receive the male luer  22 . The threaded portion  34  includes external threads  50  for engaging the threads  20  of the luer connector  12 . The external threads  50  and the threads  20  of the luer connector  12  cooperate with each other so as to allow the cap  30  to be securely threadedly connected to the luer connector  12  and also to allow relative movement between the cap  30  and the luer connector  12 , as the cap  30  is rotated relative to the luer connector  12 . The external threads  50  extend between the base  32  and the rim  40 . 
     The configuration of the cap  30  is shown in perspective in  FIG. 3 . It should be noted that this configuration is exemplary. For example, the cap  30  could be configured without threads and sized to engage the luer connector  12  with a push-on friction fit, as will be described hereinafter. 
     The cap  30  could be made from an absorbent material. The cap  30  could be made from porous plastic, for example, a medical grade sintered porous plastic material which is available from Porex Corporation, based in Fairburn, Ga. Other suitable manufacturers of the porous plastic material include Filtrona, Genpore, and Thermopore. It is desirable that the material can absorb and retain a fluid such as an antiseptic fluid. It is also desirable that the material is sufficiently rigid to maintain its structure. It is also desirable that the material is compressible and that the absorbed fluid is released on compression. The porous plastic material could be made of any suitable polymer, such as polyethylene, polypropylene, nylon, etc. 
     The use of the porous plastic material is only exemplary. It will be understood that the cap  30  could be made from any other suitable material, such as bonded fiber, cotton, silicone, urethane, polyester, cellulose, etc. The material could be natural or synthetic. 
     The threaded portion  34  of the cap  30  could be coated or impregnated with an antiseptic fluid, an anticoagulant fluid, and/or an antimicrobial fluid. An example of a suitable antiseptic fluid is isopropyl alcohol. The concentration of the isopropyl alcohol could vary, and is preferably 70% v/v. The concentration of alcohol could be in a range from 20% to 100%. It will be understand that other materials could be used, such as other alcohols, including ethanol, propanol, and/or butanol, or iodine, hydrogen peroxide, chlorhexidine gluconate, chlorhexidine acetate, etc. The antiseptic, anticoagulant, and/or antimicrobial agent could be in liquid or solid form. 
     The cap holder  28  includes a cylindrically shaped sidewall  52  that defines a chamber  54  sized to receive the cap  30  and accommodate the male luer  22 . The cap holder  28  could include an outer flange  56  that protrudes radially outwardly from a distal end  58  of the sidewall  52 . The outer flange  56  defines an open end  60 . The cap holder  28  could include a substantially flat surface  62  that defines the opposite, closed end. The cap holder  28  could be made from a thermoplastic elastomer, such as the thermoplastic elastomer sold by ExxonMobil under the trademark SANTOPRENE, or any other suitable material. The cap holder  28  could be made from a more rigid material, such as a high-density polyethylene. The cap holder  28  and the cap  30  could be bonded to each other, or attached to each other by any suitable method, such as by adhesive or by molding. 
     When the cap  30  is attached to the cap holder  28 , a gap  64  may exist between the flange  38  of the cap  30  and the cap holder  28 , and between the threaded portion  34  of the cap  30  and the cap holder  28 . Also, the cap  30  is attached to the cap holder  28  such that the cap  30  rotates conjointly with the cap holder  28 . 
     As shown in  FIG. 2 , the cap holder  28  could be sealed with a material, such as a film  66 , a foil material or lid stock material, which can be attached to the flange  56  by any suitable method such as by adhesive or by conductive or inductive heat sealing techniques. A pull tab  68  could be provided to facilitate removal of the film  66  to provide access to the antiseptic cap  10 . 
     Generally, the cap  30  may be hydrophobic. However, because the hydrophobic material could serve to inhibit or minimize an antiseptic fluid, such as isopropyl alcohol, from passing through the cap  30 , it may be desirable to make at least a portion of the cap  30  hydrophilic. For example, it may be desirable to treat at least a portion of the cap  30  with a hydrophilic surfactant. In this manner, the hydrophilic portion could allow the alcohol to pass therethrough, whereas the hydrophobic portion could serve to inhibit or minimize an antiseptic fluid, such as isopropyl alcohol, from passing therethrough. In one embodiment, the threaded portion  34  could be treated with a hydrophilic surfactant whereas the base  32  could remain hydrophobic, so as to be resistant to an antiseptic fluid, such as alcohol. The hydrophobic section could also act as a plug to prevent IV fluid from leaking through the tubing to go past the cap  30 . 
     Referring to  FIG. 1 , the antiseptic cap assembly  10  is shown attached to the luer connector  12  such that the threaded portion  34  of the cap  30  mates with the threads  20  of the luer connector  12  and the base  32  is positioned adjacent the opening  24  of the male luer  22 . Also, in this position, the inner surface  46  of the threaded portion  34  is adjacent the male luer  22  and the male luer  22  compresses the cap  30  to release at least a portion of the antiseptic fluid to disinfect the luer connector  12 . The antiseptic cap assembly  10  can be allowed to remain attached to the luer connector  12  for any suitable period of time. When the antiseptic cap assembly  10  is attached to the luer connector  12 , as shown in the perspective view of  FIG. 4 , the luer connector  12  is exposed to the antiseptic fluid. 
     The cap holder  28  could be configured to remain on the cap  30  after the antiseptic cap assembly  10  engages the luer connector  12 . Alternatively, the cap holder  28  could be configured to be removably attached to the cap  30 . For example, the cap holder  28  could be removed from the cap  30  after the antiseptic cap assembly  10  engages the luer connector  12 . 
       FIG. 5  shows an antiseptic cap assembly, indicated generally as  110 , that is sized to engage and disinfect the male luer  22 . The antiseptic cap assembly  110  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-4 , unless stated otherwise. Like the antiseptic cap assembly  10 , the antiseptic cap assembly  110  includes a cap holder  128  and a cap  130  sized to be positioned within the cap holder  128 . 
     Cap  130  includes an annular sidewall  111  extending from an outer flange  138  and substantially concentric with the threaded portion  134 . When the cap holder  128  is used, the annular sidewall  111  is positioned proximate an outer surface of the cap holder  12 . When the antiseptic cap assembly  110  is attached to the luer connector  12 , the annular sidewall  111  bears against the outer surface of the threaded portion  18  of the luer connector  12 . The annular sidewall  111  can be made from porous plastic like the remainder of the cap  130  or any other suitable material. The annular sidewall  111  covers and protects the outer surface of the threaded portion  18  of the luer connector  12 . The annular sidewall  111  may contain antiseptic fluid and release at least a portion of an antiseptic fluid. 
       FIG. 6  shows an antiseptic cap assembly, indicated generally as  210 , that is sized to engage and disinfect a male luer  22 . The antiseptic cap assembly  210  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-4 , unless stated otherwise. Like the antiseptic cap assembly  10 , the antiseptic cap assembly  210  includes a cap holder  228  and a cap  230  sized to be positioned within the cap holder  228 . 
     Cap  230  includes a center insert  211  that is integrally connected therewith. Alternatively, the cap  230  and the center insert  211  could be separate components. The center insert  211  may be made from porous plastic like the remainder of the cap  230  or any other suitable material, and may contain antiseptic fluid and release at least a portion of an antiseptic fluid. The center insert  211  could be treated with a hydrophilic surfactant, or otherwise made hydrophilic. 
     The center insert  211  protrudes from a base  232  of the cap  230  and is positioned within a threaded portion  234  of the cap  230 . The center insert  211  has a distal end  213  that may have angled edges  215 , thereby giving the center insert  211  a generally trapezoidal shape. The center insert  211  could define other shapes such as conical, square, rectangle, etc. 
     When the cap  230  is attached to a luer connector  12 , the center insert  211  is positioned within the opening  24  formed in the male luer  22  and allows the antiseptic fluid to enter the male luer  22  to apply the antiseptic fluid to the inner tip  26  of the male luer  22 . 
       FIG. 7  shows an antiseptic cap assembly, indicated generally as  310 , that is sized to engage and disinfect a male luer  22 . The antiseptic cap assembly  310  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-3 , unless stated otherwise. Like the antiseptic cap assembly  10 , the antiseptic cap assembly  310  includes a cap holder  328  and a cap  330  sized to be positioned within the cap holder  328 . 
     A sealing mechanism, such as a center plug  311 , is sized to extend from a base  332  of the cap  330  and is sized to be positioned within the threaded portion  334  of the cap  330 . The cap  330  and the center plug  311  could be separate components as shown or, alternatively, the cap  330  and the center plug  311  could be integrally formed. Alternatively, the center plug  311  could be an extension of the cap holder  328  molded in. 
     The center plug  311  has a distal end  313  that may have angled edges  315 , thereby giving the center plug  311  a generally trapezoidal shape. The center plug  311  could define other shapes such as conical, square, rectangle, etc. 
     The center plug  311  bears against the opening  24  formed in the male luer  22  to prevent the antiseptic fluid from entering the male luer  22 . The center plug  311  extends a distance from the base  332  sufficient to engage the opening  24  in the male luer  22  before the threaded portion  334  of the cap  330  is compressed by the male luer  22 , to seal the opening  24  in the male luer  22 . 
     The center plug  311  could be made of a non-porous material, such as rubber, or any other suitable material. The center plug  311  could be made of porous plastic and left in a hydrophobic state, i.e., not treated with a surfactant like the threaded portion  334  of the cap  330 , thereby inhibiting or minimizing antiseptic fluid from passing therethrough and into the opening  24  formed in the male luer  22 . In this manner, the center plug  311  serves to limit or prevent alcohol from entering the fluid line  316  of the luer connector  312 . Also the center plug  311  could act as a plug to prevent IV fluid from dripping out of the line. 
     The configuration of the sealing mechanism is only exemplary. It will be understood that the present invention could employ other sealing mechanisms. For example, the sealing mechanism could be a center pin (not shown) sized to extend further into the opening  24  formed in the male luer  22  than the center plug  311 . The center plug  311  may extend past the threads on the threaded portion  324  and inserted prior to thread engagement. 
       FIG. 8  shows an antiseptic cap assembly, indicated generally as  410 , that is sized to engage and disinfect a male luer  22 . The antiseptic cap assembly  410  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-4 , unless stated otherwise. Like the antiseptic cap assembly  10 , the antiseptic cap assembly  410  includes a cap holder  428  and a cap  430  sized to be positioned within the cap holder  428 . 
     The cap holder  428  includes an inner-facing flange  411  that may form a protective seal that closes off the interior of the cap holder  428  when the antiseptic cap assembly  410  is engaged to the luer connector  12 . The inner flange  411  extends radially inward from a distal end  458  of the sidewall  452  of the cap holder  428 . When the antiseptic cap assembly  410  is engaged to the luer connector  12 , the inner-facing flange  411  of the cap holder  428  may contact the threaded portion  18  of the luer connector  12  to seal the interior of the cap holder  428 . 
     The inner-facing flange  411  of the cap holder  428  may provide a physical barrier to the ingress of pathogens, dust or other contaminants into the cap holder  428 . The inner-facing flange  411  may serve to retain at least a portion of the antiseptic fluid from the antiseptic cap assembly  410  from leaking out. The inner-facing flange  411  may prevent evaporation of at least a portion of the antiseptic fluid that is retained. 
     The configuration of the cap holder  428  could vary. For example, the cap holder  428  could include an outer flange (not shown), such as the outer flange  56  ( FIG. 1 ) that protrudes radially outwardly from the distal end  458  of the sidewall  452 , as well as the inner-facing flange  411  that protrudes radially inward from the distal end  458  of the sidewall  452 . 
       FIG. 9  shows an antiseptic cap assembly, indicated generally as  510 , that is sized to engage and disinfect a male luer  22 . The antiseptic cap assembly  510  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-4 , unless stated otherwise. Like the antiseptic cap assembly  10 , the antiseptic cap assembly  510  includes a cap holder  528  and a cap  530  sized to be positioned within the cap holder  528 . 
     The antiseptic cap assembly  510  includes a center plug  511 , such as the center plug  311  shown in  FIG. 7 . In addition, the cap holder includes an inner-facing flange  513 , such as the flange  411  shown in  FIG. 8 . 
     It should be understood that various features of various embodiments disclosed herein could be used together without departing from the spirit or scope of the present invention. 
       FIG. 10  shows an antiseptic cap assembly, indicated generally as  610 , that is sized to engage and disinfect a male luer  22 . The antiseptic cap assembly  610  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-4 , unless stated otherwise. Like the antiseptic cap assembly  10 , the antiseptic cap assembly  610  includes a cap holder  628  and a cap  630  sized to be positioned within the cap holder  628 . 
     The cap  630  includes an annular portion  611  extending from a base  632 . The annular portion  611  is configured without threads but is sized to engage the luer connector  12  with a push-on friction fit. The antiseptic cap assembly  610  could be removed by pulling out of the luer connector  12 . 
     The annular portion  611  of the cap  630  could be configured such that the inner surface contacts the male luer  22  and is compressed by the male luer  22  to release antiseptic fluid when the cap  630  is pushed on to the male luer  22 . The outer surface of the annular portion  611  could also contact against the inner threads  18  of the threaded portion  18  of the male luer  22  and could also release antiseptic fluid on this side. Alternatively, the annular portion  611  could be configured to avoid contact with the threads  20  of the luer connector  12 . The annular portion  611  does not need to be tapered as shown. 
       FIGS. 11 and 12  show an antiseptic cap assembly, indicated generally as  710 , that is sized to engage and disinfect a male luer  22 . The antiseptic cap assembly  710  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-3 , unless stated otherwise. The antiseptic cap assembly  710  includes an antiseptic chamber  715  and a cap  730 . 
     The cap  730  includes an annular portion  711  extending from a base  732 . The annular portion  711  is configured and sized to engage the luer connector  12  with a push-on friction fit. 
     The antiseptic chamber  715  is attached to the base  732  of the cap  730  and is formed by a continuous sidewall  713  and an end wall  723 . The sidewall  713  includes an inner flange  717  that extends radially inward from the sidewall  713 . The flange  717  defines an open end  721 . 
     The base  732  of the cap  730  is keyed to the antiseptic chamber  715 . The base  732  of the cap  730  is positioned within the antiseptic chamber  715  such that the outer flange  738  of the base  732  is captured in the antiseptic chamber  715  by the inner flange  717  of the antiseptic chamber  715  which extends over the base  732 . The base  732  closes off the disinfectant chamber  715  and the annular portion  711  of the cap  730  is in contact with the inner flange  717  of the antiseptic chamber  715 . The cap  730  could be attached to the antiseptic chamber  715  such that the cap  730  rotates conjointly with the antiseptic chamber  715 . In one embodiment, the base  732  of the cap  730  does not need to be keyed to the antiseptic chamber  715  in a push-on design. 
     The antiseptic chamber  715  can include an absorbent material  725 , such as a pad, sponge, or elastomeric foam, configured to retain an antiseptic fluid. The absorbent material  725  could be wetted or soaked with the antiseptic fluid. The absorbent material  725  could be deformable. The cap  730  could be made from a porous plastic material that serves as a carrier for the transfer of antiseptic fluid from the disinfectant chamber  715 . When the cap holder  728  is compressed, the absorbent material  725  releases at least a portion of the antiseptic fluid. The fluid can then flow through the base  732  and along the annular portion  711  to be delivered to the male luer  22 .  FIG. 12  shows a perspective view of the antiseptic cap assembly  710 . 
     It will be understood that the present invention could employ other mechanisms that involve pushing on a component of an antiseptic cap assembly to activate or release the antiseptic fluid. 
       FIGS. 13-15  show an antiseptic cap assembly, indicated generally as  810 , that is sized to engage and disinfect a male luer  22 . The antiseptic cap assembly  810  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-3 , unless stated otherwise. Like the antiseptic cap assembly  10 , the antiseptic cap assembly  810  includes a cap holder  828  and a cap  830  sized to be positioned within the cap holder  828 . 
     The cap  830  includes an annular portion  811  extending from a base  832 . The annular portion  811  is configured without threads and sized to engage the luer connector  12  with a push-on friction fit. The antiseptic cap assembly  810  could be removed by pulling out of the luer connector  12 . 
     The cap holder  828  includes retainers  813  that serve to retain or secure the cap  830  on the luer connector  12 . The retainers  813  include a pair of shoulders  815 ,  817  that extend perpendicularly from opposite sides of the outer flange  856  of the cap holder  828  and a pair of arms  823 ,  825  that extend radially inward from the shoulders  815 ,  817 . 
     When the antiseptic cap assembly  810  is engaged to the luer connector  12 , the arms  823 ,  825  of the retainers  813  extend over the male luer  22  to retain the cap  830 . The retainers  813  could be made from a thermoplastic elastomer, such as SANTOPRENE, or any other suitable material. The retainers  813  could be made from a flexible material. 
     The cap holder  828  may include gripping areas defined by a recessed portion  827  ( FIGS. 13 and 15 ) and a recessed portion  829  ( FIGS. 13 and 15 ) on opposite sides of the outer sidewall  852 . The recessed portions  827 ,  829  are configured for gripping the cap  830  to attach the cap  830  to the male luer  22 . 
       FIGS. 16-18  show an antiseptic cap assembly, indicated generally as  910 , that is sized to engage and disinfect a male luer  22 . The antiseptic cap assembly  910  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-4 , unless stated otherwise. Like the antiseptic cap assembly  10 , the antiseptic cap assembly  910  includes a cap holder  928  and a cap  930  inserted within the cap holder  928 . This embodiment includes a mechanism to prevent overtightening of the cap  930  on the male luer  22  which could damage the male luer  22 . This is addressed with a ratchet assembly. 
     The cap  930  includes a base  932  and an annular threaded portion  934  extending from the base  932 . The base  932  includes an outer flange  938  with a plurality of teeth  911  (see  FIGS. 17 and 18 ), along the outer perimeter that allows for rotation in only one direction. Alternatively, it could be configured to allow for rotation in both directions by angling both surfaces of the teeth. The teeth  911  have angled faces  912  and generally perpendicular faces  914 . 
     The cap holder  928  includes a retaining mechanism for retaining the cap  930  in the cap holder  928 . The retaining mechanism could include a first protrusion  913  that extends from one section of the sidewall  952  of the cap holder  928 , and a second protrusion  915  that extends from an opposite section of the sidewall  952  of the cap holder  928 . The first and second protrusions  913 ,  915  are configured to extend over the base  932  of the cap  930 . Alternatively, the retaining mechanism could include a single ring around the interior of the cap holder  928 . 
     The cap holder  928  includes a plurality of teeth  917  that mate with the teeth  911  to form a ratchet mechanism. The teeth  917  interact with the teeth  911  to allow the cap  930  to rotate in the cap holder  928  in only one direction, and have angled faces  916  and generally perpendicular faces  918 , like the teeth  911  of the base  932 . Alternatively, it could be configured to allow for rotation in both directions. 
     The ratchet mechanism provides an audible or a tactile feedback to indicate that the antiseptic cap assembly  910  is properly secured. Also, the ratchet mechanism could limit torque to prevent damage to the luer connector  12  or to the cap  930 . The cap  930  is threaded on the male luer  22  in accordance with other embodiments of the cap  930 . If the cap  930  is turned beyond the limit of the threads, instead of damaging the male luer  22 , the cap  930  will slide with respect to the cap holder  928 , the angled teeth  911 ,  917  of the base  932  of the cap  930  and the cap holder  930  respectively sliding past one another to prevent further tightening of the cap  930  onto the male luer  22 . When removing the cap  930  from the male luer  22 , the generally perpendicular faces  914 ,  918  engage and do not permit sliding. 
       FIG. 19  shows an antiseptic cap assembly, indicated generally as  1010 , that is sized to engage and disinfect a male luer  22 . The antiseptic cap assembly  1010  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-4 , unless stated otherwise. 
     The cap  1030  is used without a cap holder. The cap  1030  includes a base  1032  and an annular threaded portion  1034  extending from the base  1032 . Antiseptic fluid can be associated with the interior surface of the annular threaded portion  1034 . 
     The configuration of the cap  1030  is only exemplary. For example, the cap  1030  could be configured without threads and sized to engage the luer connector  12  with a push-on friction fit. Likewise, the cap  1030  could also include a sidewall, like that shown in  FIG. 5 . 
       FIG. 20  shows an antiseptic cap assembly, indicated generally as  1110 , that is sized to engage and disinfect a male luer. The antiseptic cap assembly  1110  operates and is constructed in manners consistent with the antiseptic cap assembly  1010  shown in  FIG. 18 , unless stated otherwise. 
     At least a portion of the cap  1130  could be treated with a hydrophilic surfactant, or otherwise made hydrophilic. The threaded portion  1134  could be treated with a hydrophilic surfactant whereas the base  1132  could remain hydrophobic, so as to be resistant to and non-absorbent of an antiseptic fluid. 
     A center plug  1111  could bear against the opening  24  formed in the male luer  22  to prevent the antiseptic fluid from entering the male luer  22 . The center plug  1111  could be made of porous plastic and left in a hydrophobic state, thereby inhibiting or minimizing antiseptic fluid from passing therethrough and into the opening  24  formed in the male luer  22 . The hydrophobic section could also act as a plug in the IV line to prevent ingress of antiseptic fluid or to stop leakage of IV fluid. 
       FIG. 21  shows an antiseptic cap assembly, indicated generally as  1210 , that is sized to engage and disinfect a male luer  22 . The antiseptic cap assembly  1210  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-4 , unless stated otherwise. 
     The cap holder  1228  has a notch  1211  in an outer flange  1256  that is configured to attached to a supporting surface, such as a fluid line  1213 . As shown, the cap holder  1228  has a plurality of ribs  1215  extending along a sidewall  1252  from one end  1217  of the cap holder  1228  to the opposite end  1219  of the cap holder  1228 . The ribs  1215  facilitate gripping of the cap holder  1228 . 
       FIG. 22  shows an antiseptic cap assembly, indicated generally as  1310 , that is sized to engage and disinfect a male luer. The antiseptic cap assembly  1310  operates and is constructed in manners consistent with the antiseptic cap assembly  10  shown in  FIGS. 1-3 , unless stated otherwise. Like the antiseptic cap assembly  10 , the antiseptic cap assembly  1310  includes a cap holder  1328  and a cap  1330  sized to be positioned within the cap holder  1328 . 
     A sealing mechanism, such as a center plug  1311 , is sized to extend from the cap holder  1328  through the base  1332  and is sized to be positioned within the threaded portion  1334  of the cap  1330 . As such, the center plug  1311  is made of a non-porous material such as SANTOPRENE, or any other suitable material. In particular, the center plug  1311  includes an arm  1313  with one end  1315  extending from the base  1332 , and a sphere  1317  attached to an opposite end  1319  of the arm  1313 . The sphere  1317  is configured to bear against the opening  24  formed in the male luer  22  to limit the distance that the antiseptic fluid can travel into the male luer  22 . Alternatively, the center plug  1311  could extend from the base  1332  and be made of another material such as rubber. The sphere  1317  could be replaced with a non-spherical device. 
     Any of the antiseptic cap assemblies  10 ,  110 ,  210 ,  310 ,  410 ,  510 ,  610 ,  710 ,  810 ,  910 ,  1010 ,  1110 ,  1210 , and  1310  disclosed herein could be configured to be removably attached to a suitable surface (not shown), such as a IV bag, IV pump, or IV pole, etc., for use. For example, in  FIG. 23 , the substantially flat surface  62  of the cap holder  28  includes a clip  80  sized to removeably secure the antiseptic cap assembly  10  to a supporting surface (not shown), such as a IV bag. In  FIG. 24 , a hook  82  could be provided extending from the substantially flat surface  62  of the cap holder  28  and sized to removeably secure the antiseptic cap assembly  10  to a supporting surface (not shown). 
     In  FIG. 25 , a horseshoe-shaped clip  84  could be provided extending from the substantially flat surface  62  of the cap holder  28  and sized to releasably fasten an antiseptic cap assembly  10  to a supporting surface (not shown). The location of a fastening member could vary. For example, in  FIG. 26 , the sidewall  52  of the cap holder  28  includes a clip  86 . 
     In  FIG. 27 , the end surface  62  of the cap holder  28  includes an adhesive  88  that could be covered by a release sheet  89 . The adhesive  88  could be used to attach the antiseptic cap assembly  10  to a supporting surface, such as a IV pole. A pull tab  90  could be provided to remove the release sheet  89  to expose the adhesive  88 . 
     Alternative fastening mechanisms could be provided. For example, the antiseptic cap assembly could include a ring (not shown). 
     The antiseptic cap assembly could be incorporated in kits with flush syringes, caps for treating a catheter or needleless connector, and line access devices, etc. The antiseptic fluid used could include an anticoagulant material, and/or an antimicrobial material. Examples of antiseptic fluid that could be used are disclosed in U.S. patent application Ser. No. 11/821,190, filed on Jun. 22, 2007, and Ser. No. 12/214,526, filed on Jun. 19, 2008. The entire disclosures of U.S. patent application Ser. Nos. 11/821,190 and 12/214,526 are incorporated herein by reference in their entirety. 
       FIG. 28  is a perspective view of a multifunction antiseptic dead-end cap  1410 . The antiseptic dead-end cap  1410  includes a first portion  1412 , e.g., a male connector portion, that connects to a female luer (not shown) and a second portion  1414 , e.g., a female connector portion, that connects to a male luer (not shown). The male luer or the female luer may, respectively, be attached to a fluid source (not shown), such as an IV bag filled with fluid. For example, the male luer may be the male luer  22  illustrated in  FIGS. 1 and 3-27  and described with respect thereto. 
     As shown in  FIGS. 28-33 , the first portion  1412  includes a first annular wall  1416  extending from a base  1418 . The first annular wall  1416  includes one or more threads  1420  positioned on an interior wall of the first annular wall  1416 . The threads  1420  of the first portion  1412  are configured to engage and cooperate with threads of a female luer to allow the dead-end cap  1410  to be securely threadedly connected to the female luer. 
     The first annular wall  1416  defines an open end  1422 . The base  1418  closes the opposite end of the first annular wall  1416 . A cylindrical center plug  1430  extends from the base  1418  in the direction of the first annular wall  1416  and is closed by an end wall  1432 . The first annular wall  1416  and the cylindrical center plug  1430  are coaxial with one another and the cylindrical center plug  1430  is smaller in diameter than the first annular wall  1416 . The first annular wall  1416 , the base  1418 , and the cylindrical center plug  1430  define a first chamber  1424  that is annular, accessible by the open end  1422 , and sized to receive the female luer. When a female luer is inserted through the open end  1422  of the first portion  1412 , the cylindrical center plug  1430  and the end wall  1432  are inserted into a portion of the female luer. 
     The second portion  1414  includes a second annular wall  1426  extending from the base  1418  opposite the direction of the first annular wall  1416 , and forms an internal shoulder  1428  with the base  1418 . The second annular wall  1426  has an open end  1434  and forms a second chamber  1436 , while the cylindrical center plug  1430  and the end wall  1432  form a third chamber  1438 . The second chamber  1436  and the third chamber  1438  are in fluidic communication, and the second chamber  1436  is accessible by the open end  1434 . The second chamber  1436  is sized to receive a male luer. 
     One or more threads  1440  are positioned on an exterior wall of the second annular wall  1426 . The threads  1440  are configured to engage and cooperate with threads of a male luer connector, such as luer connector  12  shown in  FIG. 1 . The threads  1440  and the threads of the male luer connector cooperate with each other so as to allow the dead-end cap  1410  to be securely threadedly connected to the male luer connector. The dead-end cap  1410  may include a plurality of external ridges  1442  provided on the first portion  1412  to facilitate gripping of the dead-end cap  1410  during handling and connecting with a connector. 
     Using the male luer connector  12  shown in  FIG. 1  as an example, when the male luer connector  12  engages the second portion  1414 , the male luer  22  of the male luer connector  12  is inserted into the open end  1434  and into the second chamber  1436 . As the threads  20  of the male luer connector  12  engage the threads  1440  of the second portion  1414 , the male luer  22  traverses further into the second chamber  1436  and may traverse into the third chamber  1428 . The second annular wall  1426  could be formed with a tapered shape that compliments the male luer  22  of the luer connector  12 . In such a configuration, the second annular wall  1426  may narrow from the open end  1434  to the base  1418 . 
     As mentioned above, the antiseptic dead-end cap  1410  has a dual operability wherein it is configured to not only attach to a male luer connector, but also a female luer connector. Generally, a female luer connector can include a circumferential wall that defines a chamber and has external threads. When attaching the dead-end cap  1410  to a female luer connector, the circumferential wall of the female luer connector is inserted through the open end  1422  and into the first chamber  1424 , such that the cylindrical center plug  1420  is inserted into the circumferential wall of the female luer connector. The dead-end cap  1410  can be twisted so that the one or more threads  1420  engage the female luer connector, securing the dead-end cap  1410  with the female luer connector. 
       FIG. 33  is a cross-section of the multifunction antiseptic dead-end cap  1410  of  FIG. 28  taken along line  33 - 33 .  FIG. 33  shows the configuration of the dead-end cap  1410  in greater detail. It should be noted that this configuration is exemplary. For example, the dead-end cap  1410  could be configured without the first portion threads  1420  and/or the second portion threads  1440 . In such a configuration, the first annular wall  1416  and the cylindrical center plug  1430  may be sized to engage a female luer connector with a push-on friction fit. Similarly, the second annular wall  1426  may be sized to engage a male luer connector with a push-on friction fit. 
     The dead-end cap  1410  functions to cap a male luer connector and/or a female luer connector so that fluid does not leak from a fluid source. The dead-end cap  1410  may be used for a temporary disconnect of male and female luers so that they do not warrant disposal. 
     While the antiseptic cap disclosed herein includes male and female connector portions, it could also be provided having just a male or just a female portion. In an arrangement where the antiseptic dead-end cap  1420  includes only a male connector portion, the dead-end cap  1420  could include the base  1418 , the first annular wall  1416  extending from the base  1418 , the cylindrical center plug  1430  extending from the base  1418  in the direction of the first annular wall  1416  and closed by the end wall  1432 , and the plurality of threads  1420 . The second annular wall  1426 , and the female side of the cap can be eliminated. In an arrangement where the antiseptic dead-end cap  1420  includes only a female connector portion, the dead-end cap  1420  could include the base  1418 , the second annular wall  1426  and the threads  1440 , with the base  1418  and the second annular wall  1426  defining the second chamber  1436 . The first annular wall  1416 , and the cylindrical center plug  1430  could be eliminated. 
     Portions of the antiseptic dead-end cap  1410 , such as an inner surface of the first annular wall  1416 , the plurality of threads  1420 , an outer surface of the second annular wall  1426 , an inner surface of the second annular wall  1426 , and the second portion threads  1440 , could be coated or impregnated with an antiseptic fluid, an anticoagulant fluid, and/or an antimicrobial fluid. An example of a suitable antiseptic fluid is isopropyl alcohol. The concentration of the isopropyl alcohol could vary, and is preferably 70%. The concentration of alcohol could be in a range from 20% to 100%. It will be understand that other materials could be used, such as other alcohols, including ethanol, propanol, and/or butanol, or iodine, hydrogen peroxide, chlorhexidine gluconate, chlorhexidine acetate, etc. The antiseptic, anticoagulant, and/or antimicrobial agent could be in liquid or solid form. 
     The antiseptic dead-end cap  1410  may be constructed of a material having a 40-60 durometer hardness value on a Shore A scale. The material may be a medium soft to medium hard rubber that is plyable and malleable for purposes of engagement with a luer. 
     Antiseptic Coatings 
     It is contemplated that the devices described herein can be coated with an antiseptic coating by any suitable technique such as immersion of the part into an antiseptic solution, by spray coating the part with the antiseptic solution, by blending the antiseptic solution or material into the polymeric material used to fabricate the device. 
     A quantity of physiological, antimicrobial metal compound is added to the resin for direct molding of an article. Physiological, antimicrobial metals are meant to include the precious metals, such as silver, gold and platinum, and copper and zinc. Physiological, antimicrobial metal compounds used herein include oxides and salts of preferably silver and also gold, for example: silver acetate, silver benzoate, silver carbonate, silver citrate, silver chloride, silver iodide, silver nitrate, silver oxide, silver sulfa diazine, silver sulfate, gold chloride and gold oxide. Platinum compounds such as chloroplatinic acid or its salts (e.g., sodium and calcium chloroplatinate) may also be used. Also, compounds of copper and zinc may be used, for example: oxides and salts of copper and zinc such as those indicated above for silver. Single physiological, antimicrobial metal compounds or combinations of physiological, antimicrobial metal compounds may be used. 
     Preferred physiological, antimicrobial metal compounds used in this invention are silver acetate, silver oxide, silver sulfate, gold chloride and a combination of silver oxide and gold chloride. The particles of the silver compounds are sufficiently able to be extracted to form a zone of inhibition to prevent and kill bacteria growth. 
     In another preferred form of the invention the devices herein are impregnated with triclosan and silver compounds or triclosan and chlorhexidine, or chlorhexidine gluconate, or chlorhexidine acetate. 
     It will be understood that the embodiments described herein are merely exemplary and that a person skilled in the art may make many variations and modifications without departing from the spirit and scope of the invention. All such variations and modifications are intended to be included within the scope of the invention as defined by the appended claims.