Abstract:
Placement of a vascular access device (intravenous, intra-arterial and/or intra-osseous vascular access) in a non-sterile environment greatly increases the risk of infection via the vascular access device. This invention provides an approach for accomplishing sterilization of the site where vascular access will be attempted under non-sterile field conditions. In addition, this invention provides a sterile vascular connector pre-loaded with an antimicrobial, e.g., Taurolidine. Use of the vascular connector provides the antimicrobial concurrently with achieving vascular access, which limits the risk of infection despite access placement under non-sterile field conditions.

Description:
REFERENCE TO PENDING PRIOR PATENT APPLICATION 
       [0001]    This patent application claims benefit of pending prior U.S. Provisional Patent Application Ser. No. 62/313,848, filed Mar. 28, 2016 by CorMedix Inc. and Bruce Reidenberg et al. for FIELD STERILIZER AND IV CONNECTOR KIT (Attorney&#39;s Docket No. CORMEDIX-15 PROV), which patent application is hereby incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to medical apparatus and methods in general, and more particularly to apparatus and methods for sterile vascular access in the field and prevention of catheter-related infection. 
       BACKGROUND OF THE INVENTION 
       [0003]    1. Field Trauma 
         [0004]    In many situations, an individual may require urgent medical care in the field, e.g., in a military combat situation, in a civilian disaster recovery situation, etc. And in many of these situations, it may be necessary to provide immediate access to the vasculature of the patient (e.g., intravenous, intra-arterial and/or intra-osseous vasculature) in primitive field conditions so that appropriate fluids (e.g., saline, plasma, medications, etc.) may be administered to the patient. For the purposes of the present invention, primitive field conditions may be considered to be those where pure water may not be available for cleansing, antiseptic solutions may not be available and/or sterile supplies are limited (such as frequently occurs in military combat situations, civilian disaster recovery situations, etc.). 
         [0005]    In these situations, immediate access to the vasculature of the patient is generally achieved by cutting through the skin of the patient and then installing a vascular connector (e.g., a catheter) which provides direct access to the vasculature of the patient. Since infection is a major concern during any procedure which opens the skin and directly accesses the vasculature of a patient, and since infection is a particularly serious concern where such access must be achieved in primitive field conditions, it is desirable to do everything possible to reduce the risk of infection. Among other things, ideally, the skin of the patient should be sterilized prior to incision, and the vascular connector (e.g., the catheter) should be resistant to catheter-related infection. 
         [0006]    2. The Desirability of a Field Sterilizer and Vascular Connector Kit 
         [0007]    It will be appreciated that where an individual requires urgent medical care in the field, and where such urgent medical care requires immediate access to the vasculature of the patient in primitive field conditions, it would be desirable to provide a pre-packaged kit containing a field sterilizer and a vascular connector, where the vascular connector is resistant to catheter-related infection. 
         [0008]    However, certain challenges are encountered when trying to provide a field sterilizer and vascular connector kit. 
         [0009]    3. Disinfections Systems 
         [0010]    It is known to disinfect water (and other liquids), gases (including air), devices and/or object surfaces, etc. using ultraviolet (UV) radiation and/or disinfectants. 
         [0011]    In many situations, it can be highly desirable to disinfect a target medium using UV radiation. For this reason, the present invention is configured to use UV radiation to disinfect the skin of a patient. 
       A. UV Disinfection Systems in General 
       [0012]    Drinking water is commonly treated with UV radiation to disinfect the drinking water—the number of microbes in the water can be reliably and greatly reduced depending on the UV dose which is applied to the drinking water. Exposure to UV radiation causes microorganisms (such as pathogens and other bacteria) to be killed and viruses to be inactivated. 
         [0013]    The efficiency of a UV disinfection system is, to a large extent, determined by the UV dose and the homogeneity of the radiation field in which the target medium (e.g., drinking water) is exposed. More particularly, with UV disinfection systems equipped with only a few sources of ultraviolet light, it is difficult to achieve a sufficient homogeneity of the generated UV radiation field for effective disinfecting of the target medium (and, in addition, such systems tend to suffer from high power losses). For disinfecting purposes, it is therefore preferred to provide a highly homogeneous distribution of the UV radiation intensity. In this respect it should be appreciated that a locally-increased UV intensity is generally not detrimental to the disinfecting process, since excess UV intensity typically does not harm the target medium. However, a locally-reduced UV intensity can lead to microorganisms and/or viruses being insufficiently irradiated as they are exposed to the UV disinfection system, thereby undermining the disinfecting process. 
         [0014]    In addition to the foregoing, where there are spatial limitations, it may be important for the UV disinfection system to have a compact design (but without compromising system efficiency). In many cases, it may be necessary to reduce the number of UV radiation sources as much as possible for reasons of space (and usually also of cost). 
         [0015]    There are two basic approaches for producing UV disinfection systems. 
       B. Coaxial Geometry Approach for UV Disinfection Systems 
       [0016]    A first approach for producing a UV disinfection system uses a coaxial geometry. This coaxial geometry approach is highly compact, but it tends to suffer from radiation homogeneity problems. In a typical configuration, a rod-shaped UV light source is used to create a “UV reactor” in which UV disinfection is carried out. More particularly, the rod-shaped UV light source extends perpendicularly to the plane of the UV disinfection system, within a UV-transparent cover tube, and is arranged so that the target medium (e.g., drinking water) flows around the UV-transparent cover tube which contains the rod-shaped UV light source. Here, the UV light source, covered by the UV-transparent cover tube, is protected from the flowing target media (e.g., drinking water) by the UV-transparent cover tube. Since the radiation intensity of the UV light source decreases exponentially with distance, and since the radiation intensity of the UV light source is also weakened by absorption in the target medium, this results in a non-homogeneous radiation field. Strongly-non-homogeneous radiation fields result in a strong deviation of the UV dosage delivered across the area being treated. If there is a strongly-non-homogeneous radiation field, there will likely be areas in which existing microorganisms and viruses in the target medium cannot be irradiated sufficiently due to the low UV radiation intensity. The disinfection performance is therefore insufficient. 
       C. Elliptical Reflectors Approach for UV Disinfection Systems 
       [0017]    A second approach for producing a UV disinfection system uses elliptical reflectors to create the UV reactor. More particularly, in these UV disinfection systems, UV light sources are arranged outside of the UV reactor (i.e., the UV radiation zone) and then the UV radiation is transmitted to the UV reactor via an arrangement of elliptical reflectors. These elliptical reflectors produce a relatively homogeneous radiation field in the UV reactor, but they generally require a relatively large space to produce the relatively homogenous radiation field. For this reason, UV disinfection systems using elliptical reflectors are generally not suitable for applications which must be compact. 
       D. Deficiencies of UV Disinfection Systems 
       [0018]    Therefore, current UV disinfection systems generally provide either (i) a compact design but insufficient radiation homogeneity (e.g., UV disinfection systems using a coaxial geometry approach); or (ii) a high radiation homogeneity but require a large installation space (e.g., UV disinfection systems using elliptical reflectors). 
         [0019]    3. Catheter-Related Infection 
         [0020]    It is well known that vascular connectors (e.g., catheters) are highly susceptible to catheter-related infection. The source of the infection can be microorganisms and/or viruses present at the time of the installation of the vascular connector (e.g., catheter), or the source of the infection can be microorganisms and/or viruses which are introduced to the vascular connector (e.g., the catheter) after installation of the vascular connector (e.g., catheter). In either case, such infection is always of significant concern due to the direct access of the vascular connector (e.g., the catheter) to the vasculature of the patient. 
         [0021]    4. Primary Object of the Invention 
         [0022]    Accordingly, the primary object of the present invention is to provide a pre-packaged kit for use in rapidly accessing the vasculature of a patient in primitive field conditions, wherein the pre-packaged kit contains a field sterilizer and a vascular connector, and wherein the vascular connector is resistant to catheter-related infection. 
       SUMMARY OF THE INVENTION 
       [0023]    The present invention comprises the provision and use of a novel field sterilizer and vascular connector kit which comprises (i) a UV sterilizer, and (ii) a vascular connector pre-filled with an antimicrobial solution that is safe for injection into the patient. The UV sterilizer is compact in size and comprises at least one UV light source disposed in a reflective chamber so that UV sterilization of a skin surface can be achieved without threatening the vision of a caregiver who is conducting the treatment. The UV sterilization of the patient&#39;s skin is then followed by vascular access using the vascular connector (which is preferably in the form of a 3-way hub connector), wherein the vascular connector comprises a supply of the antimicrobial Taurolidine to prevent future catheter-related infection. 
         [0024]    In one preferred form of the invention, there is provided a field sterilizer and vascular connector kit comprising: 
         [0025]    a UV sterilizer comprising a UV light source and a power source, wherein the UV light source and the power source are configured so as to provide a UV dosage to the skin of a patient which is sufficient to effectively disinfect the skin of the patient without burning the skin of the patient; and 
         [0026]    a vascular connector releasably mounted to the UV sterilizer, wherein the vascular connector contains a supply of an antimicrobial. 
         [0027]    In another preferred form of the invention, there is provided a method for providing sterile access to the vasculature of a patient, the method comprising: 
         [0028]    providing a field sterilizer and vascular connector kit comprising:
       a UV sterilizer comprising a UV light source and a power source, wherein the UV light source and the power source are configured so as to provide a UV dosage to the skin of a patient which is sufficient to effectively disinfect the skin of the patient without burning the skin of the patient; and   a vascular connector releasably mounted to the UV sterilizer, wherein the vascular connector contains a supply of an antimicrobial;       
 
         [0031]    using the UV sterilizer to disinfect the skin of the patient; and 
         [0032]    using the vascular connector to provide access to the vasculature of the patient. 
         [0033]    In another preferred form of the invention, there is provided a UV sterilizer comprising a UV light source, a portable power source and a reflective chamber, the UV light source being positioned within the reflective chamber so that the UV light source can effect UV sterilization of a skin surface without light leakage. 
         [0034]    In another preferred form of the invention, there is provided a vascular connector comprising a hollow body pre-filled with a solution comprising Taurolidine. 
         [0035]    In another preferred form of the invention, there is provided a method for sterilizing a skin surface, the method comprising: 
         [0036]    providing a UV sterilizer comprising a UV light source, a portable power source and a reflective chamber, the UV light source being positioned within the reflective chamber so that the UV light source can effect UV sterilization of the skin surface without light leakage; and 
         [0037]    using the UV sterilizer to disinfect the skin surface. 
         [0038]    In another preferred form of the invention, there is provided a method for providing sterile access to the vasculature of a patient, the method comprising: 
         [0039]    providing a vascular connector comprising a hollow body pre-filled with a solution comprising Taurolidine; and 
         [0040]    using the vascular connector to provide access to the vasculature of the patient. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0041]    These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein: 
           [0042]      FIG. 1  is a schematic view showing the exterior of a field sterilizer and vascular connector kit formed in accordance with the present invention; 
           [0043]      FIG. 2  is a schematic view showing the underside of the field sterilizer and vascular connector kit shown in  FIG. 1 ; 
           [0044]      FIG. 3  is a schematic view showing details of the vascular connector which is mounted to the underside of the field sterilizer and vascular connector kit shown in  FIG. 1 ; and 
           [0045]      FIG. 4  is a schematic view of another vascular connector which may be used with the field sterilizer and vascular connector kit of  FIG. 1 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0046]    In accordance with the present invention, and looking now at  FIGS. 1-3 , there is provided a novel UV sterilizer and vascular connector kit  5  which may be used for sterilizing a patient&#39;s skin and then providing sterile vascular access to the vasculature of a patient. UV sterilizer and vascular connector kit  5  generally comprises (i) a UV sterilizer  10 , and (ii) a vascular connector  15  with enhanced antimicrobial action. 
         [0047]    1. UV Sterilizer  10   
         [0048]    UV sterilizer  10  is compact in size and generally comprises (i) a housing  20 , (ii) a UV light source  25 , and (iii) a power source  30  for powering UV light source  25 . See  FIGS. 1 and 2 . 
         [0049]    More particularly, in one preferred form of the invention, housing  20  generally comprises a panel  35  having a top surface  40  and a bottom surface  45 ; a front wall  50  having an outside surface  55  and an inside surface  60 ; a back wall  65  having an outside surface  70  and an inside surface  75 ; a left side wall  80  having an outside surface  85  and an inside surface  90 ; and a right side wall  95  having an outside surface  100  and an inside surface  105 . Panel  35 , front wall  50 , back wall  65 , left side wall  80  and right side wall  95  cooperate with one another as shown in  FIGS. 1 and 2  so as to form a concave recess  110  on the underside of housing  20 . 
         [0050]    Housing  20  is compact in size, e.g., it is preferably approximately 10 cm long×6 cm wide×3 cm high. 
         [0051]    Bottom surface  45  of panel  35 , inside surface  60  of front wall  50 , inside surface  75  of back wall  65 , inside surface  90  of left side wall  80  and inside surface  105  of right side wall  95  preferably all comprise a UV light-reflecting material (e.g., a high reflectance metal), such that concave recess  110  constitutes a UV light-reflecting chamber. In one preferred form of the invention, panel  35 , front wall  50 , back wall  65 , left side wall  80  and right side wall  95  are all formed out of a material which is UV light-reflecting. In another preferred form of the invention, panel  35 , front wall  50 , back wall  65 , left side wall  80  and right side wall  95  are formed out of a material which is not UV light-reflecting, and they are all coated with a material which is UV light-reflecting. 
         [0052]    In one preferred form of the invention, left side wall  80  also comprises a light baffle  115  and right side wall  95  comprises a light baffle  117 . More particularly, left side wall  80  comprises an opening  120  which is normally closed off by a UV-opaque structure  125 . However, UV-opaque structure  125  is constructed so that it may be pushed aside when desired (e.g., UV-opaque structure  125  may comprise a curtain, a plurality of bristles, etc.). Similarly, right side wall  95  comprises an opening  130  which is normally closed off by a UV-opaque structure  135 . However, UV-opaque structure  135  is constructed so that it may be pushed aside when desired (e.g., UV-opaque structure  135  may comprise a curtain, a plurality of bristles, etc.). 
         [0053]    In one preferred form of the invention, housing  20  may comprise a frame carrying one or more Mylar® (or other plastic) sheets, e.g., so that the housing can be folded along its long axis to provide a more compact shape for packaging. In another preferred form of the invention, housing  20  may comprise a plurality of self-standing Mylar® (or other plastic) sheets, etc. 
         [0054]    UV light source  25  and power source  30  (for powering UV light source  25 ) are mounted to bottom surface  45  of panel  35  so that UV light may be directed on a skin surface opposing bottom surface  45  of panel  35 . UV light source  25  and power source  30  are configured so as to provide a UV dosage to the skin of the patient which is sufficient to effectively disinfect the skin of the patient without burning the skin of the patient. UV light source  25  and power source  30  are also configured so as to provide the disinfecting UV dosage in a relatively short period of time, e.g., 30-60 seconds. UV light source  25  preferably comprises a plurality of UV light-emitting diodes (LEDs)  140  of the sort well known in the art of UV disinfection systems. Power source  30  comprises an appropriate battery (e.g., a 9V battery) for powering UV light source  25 , and may include a capacitor  145  and various control circuitry (including an on/off button  150 ), etc. of the sort well known in the art of electrical power systems. 
         [0055]    Vascular connector  15  is releasably mounted in concave recess  110  of housing  20  (e.g., vascular connector  15  is mounted to bottom surface  45  of panel  35 ) so that vascular connector  15  is readily available to be installed in a patient after UV sterilizer  10  has been used to sterilize the skin of a patient. In one preferred from of the invention, vascular connector  15  is releasably secured to bottom surface  45  of panel  35  by mounting vascular connector  15  to bottom surface  45  of panel  35  with easily-released clips of the sort well known in the art of packaging, or with other releasable securement mechanisms of the sort well known in the art of packaging. 
         [0056]    Concave recess  110  of housing  20  is preferably closed off with a sterile seal  155  which is removed in the field at the time of use. By way of example but not limitation, sterile seal  155  may comprise a pull sheet which is releasably secured to front wall  50 , back wall  65 , left side wall  80  and right side wall  95 . As a result of this construction, the various components housed in concave recess  110  (e.g., vascular connector  15 , UV light source  25  and power source  30 ) may all be maintained in a sterile condition until the time of use. 
         [0057]    2. Vascular Connector  15   
         [0058]    Vascular connector  15  preferably comprises a standard 3-way stopcock-controlled connector (see  FIG. 3 ). More particularly, vascular connector  15  preferably comprises a hollow tube  160  having a distal end  165  and a proximal end  170 . Proximal end  170  is in fluid communication with a hollow housing  175 . Hollow housing  175  preferably comprises 3 ports  180  which are in fluid communication with hollow housing  175 . Ports  180  are preferably stopcock-controlled ports. As is well known in the art, vascular connector  15  is intended to have its distal end  165  positioned within the vasculature of a patient and ports  180  used to deliver appropriate fluids (e.g., saline, plasma, medications, etc.) to the vasculature of the patient. 
         [0059]    In accordance with the present invention, vascular connector  15  is pre-filled with an antimicrobial which is safe to be injected into a patient. In the preferred form of the invention, the antimicrobial is Taurolidine, and the Taurolidine is in solution form (e.g., such as the Taurolidine catheter lock solution sold by CorMedix Inc. of Bridgewater, N.J. under the trade name Neutrolin®). The Taurolidine is contained within hollow tube  160  and hollow housing  175  of vascular connector  15  by a removable cap  185  positioned on distal end  165  of hollow tube  160  and by setting the stopcocks of ports  180  in their closed positions. Additionally, if desired, removable caps  190  may be positioned on the 3 ports  180 . Alternatively, removable cap  185  and/or removable caps  190  may be replaced by easily-punctured diaphragms of the sort well known in the art. 
         [0060]    If desired, a vascular access guidewire  195  of the sort well known in the art of catheter access may be included with, but not disposed within, vascular connector  15 . 
         [0061]    3. Use 
         [0062]    1. The site of the intended vascular access is cleaned of debris—note that there is no requirement of alcohol or betadine or other antiseptics, the site may be cleaned with local impure water, or even spit or urine, or simply brushed off with a cloth or by hand. 
         [0063]    2. Housing  20  of UV sterilizer  10  is unfolded (if it was packaged in a folded condition) and then sterile seal  155  is removed from the bottom of housing  20  of UV sterilizer  10 , thereby exposing concave recess  110  of housing  20 . 
         [0064]    3. Power source  30  is connected to UV light source  25  (if UV sterilizer  10  was packaged with power source  30  disconnected from UV light source  25 ). 
         [0065]    4. UV sterilizer  10  is placed against the skin of the patient at the site of the intended vascular access so that UV light source  25  is directed toward the site of the intended vascular access. UV sterilizer  10  makes a firm connection with the anatomy of the patient (i.e., the “rim” of concave recess  110  makes a firm connection with the skin of the patient) so as to avoid any light leakage, with UV opaque structures  125  and  135  closing off openings  120  and  130  of housing  20 , respectively. Note that if UV sterilizer  10  is being placed on a limb of the patient, openings  120  and  130  in left side wall  80  and right side wall  95 , respectively, of housing  20  can receive a portion of the patient&#39;s limb so that UV sterilizer  10  will seat in a stable manner on the limb. As this occurs, UV-opaque structures  125  and  135  may be pushed aside to the extent required to accommodate the anatomy of the patient, however, UV-opaque structures  125  and  135  will prevent UV light leakage through light baffles  115  and  117 , respectively. 
         [0066]    5. UV sterilizer  10  is activated (e.g., by pushing on/off button  150 ). When this occurs, UV light is directed onto the skin of the patient, whereby to sterilize the skin of the patient, without threatening the vision of the caregiver who is conducting the treatment (and without allowing light to escape and reveal the location of the patient, which may be important in military applications). 
         [0067]    6. When UV sterilization is completed, UV sterilizer  10  is turned off (e.g., by pushing on/off button  150  again), UV sterilizer  10  is removed from the site of the vascular access, and vascular connector  15  is removed from bottom surface  45  of panel  35 . 
         [0068]    7. Removable cap  185  is removed from distal end  165  of vascular connector  15 , distal end  165  of vascular connector  15  is advanced through the now-sterile skin surface, and distal end  165  of vascular connector  15  introduced into the vasculature of the patient. Note that the Taurolidine contained within the hollow body of vascular connector  15  provides antimicrobial action to limit catheter-related infection. Note that, if desired, vascular access guidewire  195  may be used to assist in the deployment of vascular connector  15 , in which case vascular access guidewire  195  is first passed through the skin of the patient and into the vasculature of the patient, and then vascular connector  15  is passed over vascular access guidewire  195  and through the skin of the patient and into the vasculature of the patient (note also that where the proximalmost port  180  of vascular connector  15  comprises a stopcock and/or a cap  190 , the stopcock will need to be opened and/or the cap  190  will need to be removed in order for the vascular connector  15  to be loaded over vascular access guidewire  195 ). Then vascular access guidewire  195  is withdrawn from vascular connector  15 . 
         [0069]    8. Once vascular connector  15  has been deployed in the patient, one or more of ports  180  may be connected to an appropriate fluid source for delivery of appropriate fluids (e.g., saline, plasma, medications, etc.) to the vasculature of the patient. Note that the Taurolidine contained within the body of vascular connector  15  may be pushed safely into the vasculature of the patient ahead of the fluid which is to be delivered to the patient. Alternatively, some or all of the Taurolidine contained within the body of vascular connector  15  may be removed from the body of the vascular connector  15  via one or more of the ports  180  prior to introducing a desired fluid into the vasculature of the patient. 
         [0070]    9. Once vascular connector  15  has been deployed in the vasculature of the patient, UV sterilizer  10  may be used to sterilize another tissue surface (e.g., of the same patient or of another patient). 
         [0071]    4. Alternative Vascular Connector  15 A 
         [0072]    In an alternative form of the invention, a vascular connector  15 A ( FIG. 4 ) may be provided. Vascular connector  15 A is substantially the same as vascular connector  15  described above, except that a porous disc  200  may be disposed within hollow housing  175  of vascular connector  15 A. Porous disc  200  is formed out of a material which is capable of containing and releasing an antimicrobial (e.g., porous disc  200  may be in the form of a hydrogel web or mesh). Porous disc  200  is impregnated with an antimicrobial. In the preferred form of the invention, the antimicrobial is a solution of Taurolidine, such as the Neutrolin®-heparin 100 unit catheter lock solution sold by CorMedix Inc., which is a Taurolidine solution containing low-dose heparin (heparin can be helpful to prevent clotting in vascular connector  15 A, but low-dose heparin may be preferred since the patient may be bleeding in the field). If desired, the remaining spaces within the interior of vascular connector  15 A (i.e., the spaces not taken up with porous disc  200 ) may also be filled with the Taurolidine solution. 
         [0073]    In addition, the ante-chamber of each port  180  may be filled with a gel formulation which must be removed or pierced in order to enable flow through that port. In this way, there are two lines of defense to prevent infection and biofilm. 
         [0074]    Furthermore, a port  180  may have a length of intravenous tubing pre-connected to that port and pre-filled with an antimicrobial, e.g., a catheter lock solution comprising Taurolidine such as that sold by CorMedix Inc. 
       Modifications of the Preferred Embodiments 
       [0075]    It should be understood that many additional changes in the details, materials, steps and arrangements of parts, which have been herein described and illustrated in order to explain the nature of the present invention, may be made by those skilled in the art while still remaining within the principles and scope of the invention.