Medical fluid access device with antiseptic indicator

Abstract

A medical device, such as a vascular access device, is disclosed for providing access to a medical fluid flow path for the introduction or withdrawal of medical fluids to and from the flow path. The access device includes an indicator for providing a visual indication when the access device has been exposed to an antiseptic agent. The indicator includes a substrate and a microporous layer disposed on the substrate. The microporous layer is made from a polymer material having an index of refraction from about 1.25 to about 1.6 and is configured to change from a substantially opaque state to a substantially transparent state upon exposure to an antiseptic solution. The microporous layer resumes the substantially opaque state after a period of time.

The invention is claimed as follows: 
     
         1 . An antiseptic indicator comprising:
 a substrate; and   a microporous layer disposed on the substrate, the microporous layer made from a polymer material having an index of refraction from about 1.25 to about 1.6 and configured to change from a substantially opaque state to a substantially transparent state upon exposure to an antiseptic solution, and wherein the microporous layer resumes the substantially opaque state after a period of time.   
     
     
         2 . The indicator of  claim 1 , wherein the microporous layer includes a membrane configured to be resistant to blood staining. 
     
     
         3 . The indicator of  claim 1 , wherein the microporous layer includes a membrane having a morphology with particle-like structures. 
     
     
         4 . The indicator of  claim 1 , wherein the microporous layer is a membrane made by a liquid/liquid phase separation process. 
     
     
         5 . The indicator of  claim 1 , wherein the microporous layer is directly formed on a housing of a medical fluid access device. 
     
     
         6 . The indicator of  claim 5 , wherein the substrate is formed in proximity to a connector attached to the housing, and wherein wiping or swabbing the connector with an antiseptic agent also exposes the microporous layer to the antiseptic agent. 
     
     
         7 . The indicator of  claim 1 , further including one of an anti-microbial coating, an anti-infective agent or a polyacrylic coating. 
     
     
         8 . The indicator of  claim 1 , further including a dye encapsulated in or carried by the microporous layer. 
     
     
         9 . The indicator of  claim 1 , wherein the polymer material is selected from the group consisting of polyvinylidene fluoride, polytetrafluoroethylene, ethylene tetrafluoroethylene, polychlorotrifluoroethylene, polydimethyl siloxane, polyvinylidene fluoride, polyvinyl acetate, cellulose acetate, ethylene vinyl acetate copolymer, poly methyl methacrylate, polypropylene, polyethylene, polyacrylic acid, polyvinyl chloride, and polycarbonate. 
     
     
         10 . The indicator of  claim 1 , wherein the microporous polymer material includes a plurality of porous polymer particles. 
     
     
         11 . The indicator of  claim 10 , wherein the porous polymer particles are selected from the group consisting of polyhexafluoropropyleneoxide (PHFPO); alginic acid, the sodium salt of alginic acid, and derivatives thereof; hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxymethyl cellulose, cellulose acetate butyrate, cellulose acetate, and cellulose derivatives; polytetrafluoroethylene (PTFE); e-PTFE (expanded PTFE); fluorinated ethylene propylene (FEP); perfluoroalkoxy polymer (PFA); ethylene-tetrafluoroethylene (ETFE); polyvinylidenefluoride (PVDF); polychlorotrifluoroethylene (PCTFE); poly(methylhydrosiloxane); polydimethysiloxane; acrylic and methacrylic acid, salts and derivatives thereof; and THV. 
     
     
         12 . The indicator of  claim 1 , further including a luminescent material between the substrate and the microporous layer, the luminescent material configured to emit light, wherein the microporous layer is configured to obscure the emitted light while in the substantially opaque state and to transmit the emitted light therethrough while in the transparent state. 
     
     
         13 . The indicator of  claim 12 , wherein the luminescent material is selected from the group consisting of photoluminescent compounds and chemiluminescent compounds. 
     
     
         14 . The indicator of  claim 12 , wherein the luminescent material comprises two containers with a first solution and a second solution that are mixed to emit light when swabbed with the antiseptic solution. 
     
     
         15 . The indicator of  claim 1 , wherein the substrate includes an adhesive having a color, wherein the microporous layer is configured to obscure the color while in the substantially opaque state, and wherein the microporous layer is configured so that the color is visible through the microporous layer in the transparent state. 
     
     
         16 . A medical fluid access device comprising:
 a housing;   a connector attached to the housing and defining an access site for introduction or withdrawal of a medical fluid through the housing; and   an antiseptic indicator attached to the housing, the antiseptic indicator including an exposure indicator layer and a microporous layer, the microporous layer made from a polymer material having an index of refraction from about 1.25 to about 1.6 and configured to change from a substantially opaque state to a substantially transparent state upon exposure to an antiseptic solution, and wherein the microporous layer resumes the substantially opaque state after a period of time.   
     
     
         17 . The medical fluid access device of  claim 16 , wherein the connector is one of a septum, a valve member or a gland. 
     
     
         18 . The medical fluid access device of  claim 16 , wherein the exposure indicator layer is located between the housing and the microporous layer. 
     
     
         19 . The medical fluid access device of  claim 16 , wherein a pore size of the microporous layer is smaller than a pore size of the exposure indicator layer. 
     
     
         20 . The medical fluid access device of  claim 16 , wherein the exposure indicator layer includes a substrate having a perceptible difference in appearance from the housing. 
     
     
         21 . The medical fluid access device of  claim 16 , wherein the antiseptic indicator is formed in proximity to the connector, and wherein wiping or swabbing the connector with an antiseptic agent also exposes the antiseptic indicator to the antiseptic agent. 
     
     
         22 . The medical fluid access device of  claim 16 , wherein the antiseptic indicator includes microcracks or micropatterns that change in appearance upon wetting with an antiseptic agent. 
     
     
         23 . The medical fluid access device of  claim 16 , wherein the antiseptic indicator is adhered to the housing. 
     
     
         24 . The medical fluid access device of  claim 16 , wherein the antiseptic indicator is laser welded to the housing. 
     
     
         25 . The medical fluid access device of  claim 16 , wherein the antiseptic indicator is chemically bonded to the housing. 
     
     
         26 . The medical fluid access device of  claim 16 , wherein the antiseptic indicator is attached to the housing by radiant energy. 
     
     
         27 . The medical fluid access device of  claim 16 , wherein the antiseptic indicator is molded to the housing. 
     
     
         28 . A method of detecting an antiseptic solution on a medical fluid access device having a housing and a connector, the method comprising:
 preparing an antiseptic indicator including a substrate and a microporous layer, the microporous layer made from a polymer material having an index of refraction from about 1.25 to about 1.6 and configured to change from a substantially opaque state to a substantially transparent state upon exposure to an antiseptic solution, and wherein the microporous layer resumes the substantially opaque state after a period of time;   attaching the antiseptic indicator to the housing of the medical fluid device in proximity to the connector of the medical fluid device;   wiping the connector with the antiseptic solution; and   causing the appearance of the antiseptic indicator to change upon exposure to the antiseptic solution.   
     
     
         29 . The method of  claim 28 , including attaching the antiseptic indicator to the housing with an adhesive. 
     
     
         30 . The method of  claim 28 , including attaching the antiseptic indicator to the housing laser welding. 
     
     
         31 . The method of  claim 28 , including attaching the antiseptic indicator to the housing chemical reactions or chemical bonds. 
     
     
         32 . The method of  claim 28 , including attaching the antiseptic indicator to the housing radiant energy. 
     
     
         33 . The method of  claim 28 , including attaching the antiseptic indicator to the housing an insert molding or two-shot molding process.