FIELD STERILIZER AND VASCULAR CONNECTOR KIT

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.

Claims

1. 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.

2. A field sterilizer and vascular connector kit according to claim 1 wherein the UV sterilizer comprises a housing defining a reflective chamber, and further wherein the UV light source is disposed in the reflective chamber.

3. A field sterilizer and vascular connector kit according to claim 2 wherein the housing comprises at least one opening communicating with the interior of the reflective chamber, and further wherein the at least one opening comprises a UV-opaque structure for adjustably closing off that at least one opening.

4. A field sterilizer and vascular connector kit according to claim 2 wherein the housing comprises a panel and at least one wall connected to the panel, and further wherein the panel and the at least one wall define the reflective chamber.

5. A field sterilizer and vascular connector kit according to claim 2 wherein the housing comprises a frame and at least one sheet of material connected to the frame.

6. A field sterilizer and vascular connector kit according to claim 5 wherein the at least one sheet of material is reflective.

7. A field sterilizer and vascular connector kit according to claim 6 wherein the at least one sheet of material is selected from the group consisting of Mylar® and other plastics.

8. A field sterilizer and vascular connector kit according to claim 5 wherein the at least one sheet of material is coated with a reflective material.

9. A field sterilizer and vascular connector kit according to claim 1 wherein the UV light source comprises at least one UV light-emitting diode.

10. A field sterilizer and vascular connector kit according to claim 1 wherein the power source comprises a battery.

11. A field sterilizer and vascular connector kit according to claim 2 wherein the vascular connector is releasably mounted within the reflective chamber.

12. A field sterilizer and vascular connector kit according to claim 11 wherein the reflective chamber is closed off by a removable sterile seal.

13. A field sterilizer and vascular connector kit according to claim 1 wherein the vascular connector comprises a body having a hollow interior, a distal opening and at least one proximal opening, and further wherein the distal opening and the at least one proximal opening are selectively sealed so as to releasably contain the supply of the antimicrobial within the hollow interior of the body.

14. A field sterilizer and vascular connector kit according to claim 1 wherein the antimicrobial comprises Taurolidine.

15. A field sterilizer and vascular connector kit according to claim 14 wherein the Taurolidine is in solution form.

16. A method for providing sterile access to the vasculature of a patient, the method comprising: 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; using the UV sterilizer to disinfect the skin of the patient; and using the vascular connector to provide access to the vasculature of the patient.

17. 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.

18. A UV sterilizer according to claim 17 wherein the UV light source is specifically selected to deliver sterilizing radiation without producing a skin burn on the patient.

19. A UV sterilizer according to claim 17 wherein the UV sterilizer comprises a housing defining the reflective chamber, and further wherein the housing is constructed of a frame and at least one sheet of material connected to the frame.

20. A UV sterilizer according to claim 19 wherein the at least one sheet of material comprises Mylar®.

21. A vascular connector comprising a hollow body pre-filled with a solution comprising Taurolidine.

22. A vascular connector according to claim 21 wherein the vascular connector comprises a 3-way intravenous hub connector with luer locks.

23. A vascular connector according to claim 21 wherein the solution comprises Taurolidine and low dose heparin.

24. A vascular connector according to claim 21 wherein the hollow body comprises a port and a length of intravenous tubing pre-filled with a solution comprising Taurolidine.

25. A method for sterilizing a skin surface, the method comprising: 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 using the UV sterilizer to disinfect the skin surface.

26. A method for providing sterile access to the vasculature of a patient, the method comprising: providing a vascular connector comprising a hollow body pre-filled with a solution comprising Taurolidine; and using the vascular connector to provide access to the vasculature of the patient.

Description

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'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'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 15A

[0072] In an alternative form of the invention, a vascular connector 15A (FIG. 4) may be provided. Vascular connector 15A 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 15A. 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 15A, 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 15A (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.