Single use caps and covers for vascular access devices, and kits and methods for using the same

Abstract

This invention concerns improved single use caps or covers for vascular access devices such as needlefree connectors that are used, for example, in intravenous administration sets and extension sets. Removal of a single use cap or cover according to the invention from a vascular access device destroys the cap such that it cannot be reused. Such single use caps and covers will help ensure compliance with infection prevention protocols in healthcare settings, which will assist in reducing the incidence of healthcare-associated infections (HAIs), particularly catheter-related blood stream infections. Assemblies and kits its including such caps and covers, for example, IV administration and extension sets that include one or more needlefree connectors, as well as methods for using such caps and covers, are also described.

What is claimed is: 
     
         1 . A single use vascular access port cap configured to prevent reuse of the single use cap after removal from a vascular access port of a vascular access device, the single use cap comprising:
 a. a cap body comprising an optionally substantially cylindrical sidewall that, with a closed end wall, forms a cavity, wherein the sidewall is configured to cover an exterior portion of a vascular access port of a vascular access device to which the cap is attached and wherein the closed end wall is connected to the sidewall so as to form the cavity and prevent access to a needlefree valve portion or injection portion of the vascular access port when the cap is attached to the vascular access port;   b. an opening defined by a first edge of the sidewall and opposite the closed end wall, which opening is sized to allow the single use cap to be placed over the vascular access port such that at least a needlefree valve portion or injection portion of the vascular access port is disposed inside the cavity when the cap is removably attached to the vascular access port;   c. at least one separating region in the cap body, optionally a tear strip bounded by two spaced tearable regions, configured to allow the sidewall to be separated as so to allow the cap to be removed from the vascular access port to which it has been attached and to prevent functional reattachment to the same or different vascular access port; and   d. a pull tab connected to a portion of the sidewall proximate to the first edge of the sidewall and at least one separating region, wherein the pull tab is configured for grasping by a user and, when pulled, to cause the sidewall to separate in at least a portion of the separating region so as to allow the user to then remove the cap from the vascular access port.   
     
     
         2 . A single use cap according to  claim 1  wherein the cavity is substantially cylindrical. 
     
     
         3 . A single use cap according to  claim 1  configured to be press-fit to the vascular access port. 
     
     
         4 . A single use cap according to  claim 4  that further comprises a (i) a circumferential channel formed into an interior surface of the sidewall and configured to matingly engage a complementary collar or flange on the vascular access port, (ii) a plurality of protrusions extending from an interior surface of the sidewall, or (iii) threads or thread tabs to engage complementary threads on the vascular access port. 
     
     
         5 . A single use cap according to  claim 4  wherein the plurality of protrusions extend toward the closed end wall, wherein at least some of the protrusions optionally are configured to engage portions of threads or thread tabs disposed on an outer surface of the vascular access port. 
     
     
         6 . A single use cap according to  claim 1  wherein the separating region comprises a tear strip bounded by a pair of spaced, optionally substantially parallel, separating lines, the tear strip extending at least from the first edge of the sidewall toward, and optionally into, the closed end wall and wherein the pull tab is connected to the tear strip. 
     
     
         7 . A single use cap according to  claim 1  comprised of a thermoplastic resin, wherein the cap optionally is formed by injection molding. 
     
     
         8 . A single use cap according to  claim 1  further comprising a vent, wherein the vent optionally includes a gas-permeable barrier to allow gas but not microorganisms to pass through the vent. 
     
     
         9 . A single use cap according to  claim 1  that further comprises a port-engaging element that engages the needlefree valve portion or injection portion of the vascular access port, wherein the port-engaging element optionally provides continuing antimicrobial action when the cap is attached to a vascular access port. 
     
     
         10 . A single use cap according to  claim 1  wherein the vascular access device is selected from the group consisting of a needlefree connector, a Y-site comprising a needlefree connector portion, a Y-site comprising a needle injection port, a T-site comprising a needlefree connector portion, and a T-site comprising a needle injection port. 
     
     
         11 . An assembly that comprises a single use cap according to  claim 1  attached to a vascular access port of a vascular access device. 
     
     
         12 . An assembly according to  claim 11  wherein the vascular access device is included in an IV set, optionally a primary IV administration set, a secondary IV administration set, an IV extension set, a needlefree connector, or a vascular access connector that comprises a needle injection port. 
     
     
         13 . A kit that comprises an assembly according to  claim 11  packaged in a sealed container, wherein the kit optionally is sterilized, optionally by gamma irradiation, an electron beam, or by a sterilizing gas, optionally ethylene oxide. 
     
     
         14 . A method of capping, covering, or protecting a vascular access port of a vascular access device, comprising attaching a single use cap according to  claim 1  to the vascular access port to be capped, covered, or protected, thereby capping, covering, or protecting the vascular access port. 
     
     
         15 . A method of uncapping, uncovering, or de-protecting the vascular access port of an assembly according to  claim 11 , comprising using the pull tab to tear a seam in the single use cap's sidewall and removing the cap to thereby uncap, uncover, or de-protect the vascular access port.