Patent Document

CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application claims priority under 35 U.S.C. §119(e) upon U.S. Provisional Patent Application No. 61/786,930, entitled “INTRAVENOUS CONNECTOR HAVING ANTIMICROBIAL TREATMENT” filed on Mar. 15, 2013, by Patrick E. Eddy, the entire disclosure of which is incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention generally relates to medical valves and needleless connectors for intravenous (IV) applications, more particularly to IV connectors having one end configured for attaching to an IV tube and another end configured to receive a syringe for administering medicine to a patient. 
         [0003]    Needleless IV connectors having valve mechanisms are known in the art, an example of which is the medical valve described in U.S. Pat. No. 5,685,866 assigned to ICU Medical, Inc. who also makes such needleless IV connectors under the trademark MicroClave®. One of the MicroClave® needleless IV connectors is available with an antimicrobial treatment, where the antimicrobial treatment consists of ionic silver. Such ionic silver, however, is subject to leaching over time. 
       SUMMARY OF THE INVENTION 
       [0004]    According to an embodiment of the present invention, an IV connector is provided comprising a valve body having an open first end configured to receive a syringe for administering medicine to a patient; and a silicone seal member disposed in the valve body and exposed at the open first end of said valve body configured to receive the syringe, wherein an antimicrobial material is incorporated on or within the silicone member and is coated on the valve body, wherein said antimicrobial material comprises a silane quaternary ammonium salt. 
         [0005]    According to another embodiment of the present invention, a method for making an IV connector having a valve body and a silicone seal member is provided, where the method comprises the steps of providing a silicone slurry including therein an antimicrobial material comprising a silane quaternary ammonium salt, processing the slurry to form the silicone member, and assembling the silicone member and the valve body. 
         [0006]    According to another embodiment of the present invention, an intravenous connector is provided comprising: a valve body having an open first end configured to receive a syringe for administering medicine to a patient, and a second end opposite the first end; a spike element having a tapered hollow spike terminating in a tip at a first end and having a second end configured for attaching to an intravenous tube, said spike element secured in said valve body such that said tip is disposed proximate the first end of said valve body and the second end of said spike element is located at the second end of said valve body; and a pliable seal member disposed in said valve body around said tapered hollow spike and exposed at the open first end of said valve body configured to receive the syringe, wherein an antimicrobial material is incorporated on or within said seal member and is coated on said valve body and said spike element, and wherein said antimicrobial material comprises a silane quaternary ammonium salt. 
         [0007]    In one or more of these embodiments, the silane quaternary ammonium salt may comprise 3-(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride. 
         [0008]    These and other features, advantages, and objects of the present invention will be further understood and appreciated by those skilled in the art by reference to the following specification, claims, and appended drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]    In the drawings: 
           [0010]      FIG. 1  is a perspective view of a needleless IV connector that may be treated according to one embodiment of the present invention; 
           [0011]      FIG. 2  is an exploded perspective view of the valve shown in  FIG. 1 ; 
           [0012]      FIG. 3  is a longitudinal cross-sectional view of the assembled valve of  FIG. 1 ; 
           [0013]      FIG. 4  is a schematic, longitudinal, cross-sectional view of the assembled valve of  FIG. 1  before compressing the seal; and 
           [0014]      FIG. 5  is a schematic, longitudinal, cross-sectional view similar to  FIG. 4  showing the valve during compression of the seal. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0015]    Reference will now be made in detail to the present preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numerals will be used throughout the drawings to refer to the same or like parts. In the drawings, the depicted structural elements are not to scale and certain components are enlarged relative to the other components for purposes of emphasis and understanding. 
         [0016]    As noted above, the embodiments described herein pertain to IV connectors/ports, with or without valves. Needleless IV connectors are connected to one end of an IV tube or luer and may remain in place for the duration of a patent&#39;s stay in the medical facility in which the IV is administered. Such needleless IV connectors may thus be handled by various staff members and may be used to administer numerous dosages of medication or to withdraw fluid. Because such needleless IV connectors provide a path into the patient&#39;s bloodstream, it is important that they do not harbor bacteria or other microbes. 
         [0017]    A novel needleless IV connector is disclosed herein that not only provides the requisite properties for a needleless IV connector, but also eliminates bacteria on contact. As discussed below, the components of the connector are either treated with or formed with an antimicrobial substance comprising a silane quaternary ammonium salt. One example of a needleless IV connector that may be so treated is shown in  FIGS. 1-5 , which correspond to  FIGS. 1-5  of the aforementioned U.S. Pat. No. 5,685,866, the entire disclosure of which is hereby incorporated herein by reference. 
         [0018]    As illustrated, needleless IV connector  10  has a valve body  12 , a seal (or septum)  36 , and a spike element  24 . Valve body  12  includes an upper conduit  20 , a skirt  16 , an annular ring  14 , locking ears  22  (or optionally threads), and an annular lip  25  with an opening  25   a.  Valve body  12  provides an opening with threads  44  that may engage a cap or other medical device such as a container, IV tube, or luer. Valve body  12  is generally tubular as discussed further below. Valve body  12  may be formed of a thermal plastic. 
         [0019]    Seal  36  has a seal cap  40  with a generally flat top surface  40   b,  a lower lip  42 , and a tapered side-wall  38  having a plurality of longitudinal grooves  43  to facilitate compression of the seal. Seal  36  has an opening at the end where the lower lip  42  is located presenting a cavity  37  for receiving spike element  24 . The outer dimensions of seal  36  are chosen to allow seal  36  to be inserted within the inside of valve body  12 . Seal  36  may be formed of silicone or some other pliable material. 
         [0020]    Spike element  24  includes a hollow spike  26  terminating at a tip  32  at one end and an inner conduit  18  at the other end. An annular cuff  28  is positioned between hollow spike  26  and inner conduit  18 . Hollow spike  26  includes a longitudinal through hole  34  and protruding ridges  30 . Annular cuff  28  may include a rim  28   a  and an annular detent  28   b  for receiving lower lip  42  of seal  36 . Annular detent  28   b  snaps into an annular groove  14   b  in the underside of annular ring  14 . Seal  36  fits into annular cuff  28  and is held in place by an internal lip  27 . Spike element  24  may be formed of a thermal plastic. 
         [0021]    As shown in  FIGS. 4 and 5 , a syringe  46  may have its nose  48  pushed against flat top surface  40   b  of seal cap  40  so as to compress seal  36  until nose  48  receives the spike element  24  sufficiently deep that through hole  34  is exposed in syringe  46 . A plunger  49  may then be drawn outward to draw fluid. The valve may be rotated 180 degrees such that fluid flows in the opposite direction whereby medication may be injected from the syringe. 
         [0022]    In general, silicone such as that used for seal  36  is formed from a slurry processed at relatively low temperatures. The low temperatures at which the slurry is formed allow an antimicrobial material to be mixed in with the slurry and therefore integrated within the resulting silicone seal. Also, the outer surfaces of the thermal plastic portions (i.e., the valve body  12  and spike element  24 ) may be wiped, sprayed or dipped in the antimicrobial material. Thus, for example, an IV connector may be made having improved antimicrobial properties, not only on the outside of the connector, but also throughout the silicone seal. 
         [0023]    As mentioned above, the antimicrobial material includes a silane quaternary ammonium salt. Preferred commercially available silane quaternary ammonium salts include: MicrobeCare™ XLP, which is available from MicrobeCare, LLC of Allendale, Mich.; “PROMOFRESH X 105” from Piedmont Chemical Industries I, LLC of High Point, N.C.; and AEM 5772 Antimicrobial, which is available from Aegis Environments of Midland, Mich.. The antimicrobial could also be AEGIS Microbe Shield™ (from Aegis Environments, Midland, Mich.), which is a copolymer of chloropropyltrihydroxysilane and octadecylaminodimethyltrihydroxysilylpropyl ammonium chloride. 
         [0024]    Silane quaternary ammonium salts are particularly well-suited for the antimicrobial material as they are long lasting and capable of emitting ions that aid in the destruction of a microbe. In addition, they are organofunctional silanes that include a monomer including a silane, a positively charged nitrogen molecule, and a long molecular chain. The silane bases of these monomers can covalently and permanently bond to each other and any surface. In addition, silane quaternary ammonium salts are preferable as they are substantially free from arsenic, silver, tin, heavy metals and polychlorinated phenols. Also, they are safe to apply to the patient. In addition, it not only eliminates bacteria on contact, but it remains on the treated surfaces and kills any bacteria subsequently contacting these surfaces. Such treatment preferably lasts at least one week, more preferably several months, and most preferably indefinitely. 
         [0025]    Microbes may include bacteria, mold, mildew, algae, etc. The cell membranes of the microbes are attracted to, and then are punctured by, the long molecular chains of the monomers. As the microbes are drawn closer because of the positive-negative ion exchanges, the monomers penetrate further into the cell membranes. Once the cell membranes are penetrated deeply, they are physically ruptured by a sword-like action and then electrocuted by positively charged nitrogen molecules of the monomers, thus destroying the microbes. Thus, the microbes are eliminated without “using up” any of the antimicrobial active ingredients, which remain on and within the IV connector ready to continue protecting the patient against further microbial contamination. 
         [0026]    If the antimicrobial material used in the silicone slurry is a 3-(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride material available from MicrobeCare, LLC, it includes an active ingredient of about 43% by weight 3-(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride and about 57% by weight inert ingredients. 
         [0027]    The antimicrobial substance may then be mixed into the silicone slurry in various amounts of anywhere from about 0.001% to about 50% by weight to achieve the desired degree of antimicrobial activity while not compromising the desirable properties of the silicone sea I. 
         [0028]    To coat the thermal plastic components they may be sprayed or dipped in a solution containing the antimicrobial material. Alternatively, the antimicrobial treatment solution may be applied using wipes soaked in such a solution. Suitable wipes and solutions are disclosed in commonly-assigned U.S. Pat. No. 8,491,922, the entire disclosure of which is incorporated herein by reference. In this case, the antimicrobial material is again one of the silane quaternary ammonium salts described above. 
         [0029]    In a preferred form, the antimicrobial treatment solution contains 30-50 percent by volume isopropyl alcohol and 50-70 percent by volume antimicrobial treatment substance, which is preferably a silane quaternary ammonium salt having an unreacted organofunctional silane. If the antimicrobial treatment solution is applied by spraying or dipping, the solution most preferably includes 50 percent by volume isopropyl alcohol and 50 percent by volume of the unreacted antimicrobial treatment substance. If the solution is applied using the wipes, the solution is preferably 30 percent by volume isopropyl alcohol and 70 percent by volume of the unreacted antimicrobial treatment substance. 
         [0030]    The isopropyl alcohol may have a concentration of 70-90 percent by volume. By providing the unreacted organofunctional silane in isopropyl alcohol, the organofunctional silane does not react with the wipe substrates or the inside of the wipe container such that it is free to later react and permanently covalently bond with the inner and outer surfaces of the plastic components. Isopropyl alcohol is preferred as it evaporates quickly once the solution is wiped onto the treated surface to allow the unreacted organofunctional silane to more quickly react with the treated surface. 
         [0031]    The preferred organofunctional silane quaternary ammonium salt also prevents odor, staining and product deterioration that may be associated with microbe contamination. The preferred organofunctional silane quaternary ammonium salt is also beneficial because it permanently bonds to a treated surface, covers a broad spectrum of activity with no negative effects or drawbacks, and is easily incorporated and easily verifiable. 
         [0032]    The preferred organofunctional silane quaternary ammonium salt is designed to react and create a covalent bond with the surfaces of the plastic components. The reacted substance is held onto those surfaces until the covalent bond is broken. Tests have shown that most industrial cleaners or disinfectants will not remove the preferred antimicrobial treatment substance. The method of removal is by abrasion. 
         [0033]    In addition to treating the plastic components of the connector, male and female luer caps that may be placed on either ends of the connector may also be treated with the antimicrobial solution. Examples of caps that may be treated include the DualCap™ caps for use on needleless luer access valves, which is available from Catheter Connections, Inc. of Salt Lake City Utah. 
         [0034]    Although the invention is described with respect to a particular construction of a needleless IV connector shown in  FIGS. 1-5 , the construction thereof may vary. For example, the valve portion in the seal may include a duck bill-type valve. An example of such a needleless catheter connector with a duck bill valve is available from ICU Medical, Inc. under the trademark Neutron™. Also, the present invention may be applied to arterial connectors, catheter connectors, and dialysis connectors. 
         [0035]    The above description is considered that of the preferred embodiments only. Modifications of the invention will occur to those skilled in the art and to those who make or use the invention. Therefore, it is understood that the embodiments shown in the drawings and described above are merely for illustrative purposes and not intended to limit the scope of the invention, which is defined by the claims as interpreted according to the principles of patent law, including the doctrine of equivalents.

Technology Category: 1