Automated disinfection of vascular access device connectors

Abstract

To provide a housing for disinfecting a vascular access device connector.SOLUTION: There is provided a housing for disinfecting a vascular access device connector includes: a body which includes a distal end, a proximal end, and a lumen extending through the distal end and the proximal end, in which the distal end is arranged so as to receive the vascular access device connector, the proximal end is arranged so as to receive an injection device, and which includes an access opening; and a cover which is connected to the body, covers the access opening, includes an antibacterial compound, is arranged so as to automatically close in response to removal of the injection device from the access opening, in which the antibacterial compound automatically comes into contact with the proximal end of the vascular access device connector, and which is arranged so as to perform scrubbing.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] Intravenous catheters are commonly used for a variety of infusion therapies. For example, intravenous catheters may be used to infuse fluids such as normal saline solution, various medications, and parenteral nutrients into a patient. Intravenous catheters may also be used to withdraw blood from a patient. [Background technology]

[0002] Common types of catheters are peripheral intravenous catheters ("PIVC"), peripherally inserted central catheters ("PICC"), or midline catheters. Venous catheters may comprise "over-the-needle" catheters, which may be mounted over an introducer needle with a sharp distal tip. The sharp distal tip may be used to puncture the skin and the patient's blood vessel. Insertion of the catheter into the blood vessel may follow puncture of the blood vessel with the needle. The needle and venous catheter are typically inserted through the skin at a shallow angle into the patient's vascular system, with the bevel of the needle facing away from the patient's skin. Once placement of the introducer needle within the vascular system is confirmed, the physician may temporarily block flow within the vascular system, withdraw the introducer needle, and leave the catheter in place within the blood vessel for subsequent blood withdrawal and / or fluid injection.

[0003] Needle connectors may be used to connect intravenous catheters with medical devices for fluid administration or blood withdrawal. The medical devices may include infusion bags, syringes, etc. Often, the proximal end of a needleless connector remains exposed to a non-sterile surface during infusion therapy. When the proximal end of a needleless connector is exposed, it may become contaminated by the physician, patient, bed, table, floor surface, or other contamination source.

[0004] Exposed needleless connectors are potential sites for intraluminal microbial contamination, which may result in catheter-related bloodstream infections ("CRBSIs"). CRBSIs are a significant cause of illness and increase healthcare costs, with approximately 250,000 CRBSIs occurring annually in U.S. intensive care units. Despite guidelines to help reduce healthcare-associated infections, CRBSIs continue to plague our healthcare system. During fluid administration, needleless connectors have been identified as a source of contamination resulting in CRBSIs.

[0005] Current standards encourage disinfection of needleless connectors through vigorous mechanical scrubbing and drying before each use, and suggest the use of passive antiseptic caps. Adherence to needleless connector disinfection protocols varies among physicians, and different manufacturers require different scrubbing lengths and drying times, complicating the process. This often results in inadequate disinfection of needleless connectors and increases the risk of bloodborne infection. The use of passive antiseptic caps is not widespread these days, and adherence to cap use protocols is often variable among physicians, depending on hospital policy, and increases physician time spent locating and using antiseptic caps.

[0006] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is merely provided to illustrate one example technology area where some implementations described herein may be practiced. Summary of the Invention

[0007] In some embodiments, a device for connecting a vascular access device to a medical device may include a body, a spring, and a housing. In some embodiments, the body may include a distal end, a proximal end, and a lumen extending through the distal end and the proximal end. In some embodiments, the proximal end of the body may include a connector, which may include a needleless connector or another connector. In some embodiments, the distal end of the body may include a luer connector or another suitable connector coupled to the vascular access device.

[0008] In some embodiments, a housing may be coupled to a proximal end of the spring and may enclose the connector. In some embodiments, a distal end of the spring may be coupled to the body. In some embodiments, the housing may include a flap, which may include an antimicrobial compound. In some embodiments, when the housing is disposed in a proximal position, the flap may cover the connector, the antimicrobial compound may contact the connector, and the spring may be uncompressed. In some embodiments, in response to movement of the housing from a proximal position to a distal position, the spring may be compressed and the flap may open.

[0009] In some embodiments, the device may include a support structure, which may include one or more extension guides. In some embodiments, the housing may include one or more flanges. In some embodiments, the flanges may be arranged to move distally along the extension guides in response to movement of the housing from a proximal position to a distal position.

[0010] In some embodiments, the extension guide may include one or more stops. In some embodiments, the flange may be proximally positioned and configured to move distally along the extension guide when spaced from the stop. In some embodiments, in response to distal movement of the housing and contact of the flange with the stop, the housing and support structure may be configured to move distally together.

[0011] In some embodiments, the proximal end of the support structure may include an opening, in some embodiments, the diameter of the opening may be smaller than the diameter of the flap, which may prevent the flap from fully opening when the housing is disposed in the proximal position.

[0012] In some embodiments, an apparatus for disinfecting a vascular access device connector may include an inner housing and an outer housing. In some embodiments, the inner housing may include a proximal opening and may be positioned to receive the vascular access device connector. In some embodiments, the outer housing may be movable relative to the inner housing between a proximal position and a distal position. In some embodiments, the outer housing may include a set of teeth.

[0013] In some embodiments, the device may include a ratchet wheel, which may include an inner set of teeth and an outer set of teeth. In some embodiments, the first mandrel may extend through the ratchet wheel and may include a pawl. In some embodiments, the second mandrel may be positioned on an opposite side of the inner housing as the first mandrel.

[0014] In some embodiments, the antimicrobial strip may be wrapped around a second mandrel and connected to the first mandrel. In some embodiments, the antimicrobial strip may extend beyond the proximal opening of the inner housing. In some embodiments, in response to movement of the outer housing between the proximal and distal positions, the pawl may grip the inner set of teeth, one set of teeth on the inner surface may sequentially engage the outer set of teeth, and the ratchet wheel and mandrel may rotate to move the antimicrobial strip across the proximal opening of the inner housing.

[0015] In some embodiments, in response to movement of the outer housing between the proximal and distal positions, the antimicrobial strip may wrap around the first mandrel and / or unwrap from the second mandrel. In some embodiments, the antimicrobial strip may include a plurality of holes positioned to allow connection of a medical device to a vascular access device connector for infusion or blood withdrawal.

[0016] In some embodiments, the outer housing may include a flap that may open in response to movement of the outer housing between a proximal position and a distal position. In some embodiments, the outer housing may be positioned to surround the vascular access device connector.

[0017] In some embodiments, the device may include a separate ratchet wheel. In some embodiments, the first mandrel may extend through the ratchet wheel. In some embodiments, the antimicrobial strip may be disposed between the ratchet wheel and the separate ratchet wheel. In some embodiments, the device may include an arm extending through the mandrel. In some embodiments, the mandrel may be arranged to rotate relative to the arm. In some embodiments, the arm may be connected to the inner housing.

[0018] The object and advantages of the embodiments will be realized and achieved at least by the elements, features, and combinations particularly pointed out in the claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention, as claimed. [Brief explanation of the drawings]

[0019] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings.

[0020] [Figure 1]FIG. 1 is a top perspective view of an exemplary catheter system, according to some embodiments. [Figure 2A] FIG. 1 is a top perspective view of an exemplary device for coupling a catheter system to a medical device, showing an exemplary housing of the device positioned in a proximal position, according to some embodiments. [Figure 2B] 2B is another top perspective view of the device of FIG. 2A showing the housing positioned in a first distal position, according to some embodiments. [Figure 2C] 2B is another top perspective view of the device of FIG. 2A showing the housing positioned in a second distal position, according to some embodiments. [Figure 3A] 2B is a cross-sectional view of the device of FIG. 2A showing the housing disposed in a proximal position and with an outer portion, according to some embodiments. [Figure 3B] 2C is a cross-sectional view of the device of FIG. 2B showing the housing positioned at a first distal position, according to some embodiments. [Figure 3C] 2D is a cross-sectional view of the device of FIG. 2C showing the housing positioned in a second distal position, according to some embodiments. [Figure 4A] FIG. 1 is an expanded view of another exemplary catheter system, according to some embodiments. [Figure 4B] FIG. 4B is a top perspective view of an exemplary housing of the catheter system of FIG. 4A, showing the housing in a closed position, according to some embodiments. [Figure 4C] 4C is another top perspective view of the housing of FIG. 4B, showing the housing in an open position, according to some embodiments. [Figure 4D] FIG. 4C is another top perspective view of the housing of FIG. 4B connected to an exemplary needleless connector, according to some embodiments. [Figure 4E] FIG. 10 is a bottom view of an exemplary cover, according to some embodiments. [Figure 5A] FIG. 1 is an expanded view of another exemplary catheter system, according to some embodiments. [Figure 5B]FIG. 5B is a top perspective view of an exemplary housing of the catheter system of FIG. 5A, showing the housing in a closed position, according to some embodiments. [Figure 5C] FIG. 5C is another top perspective view of the housing of FIG. 5B, showing the housing in an open position, according to some embodiments. [Figure 5D] FIG. 5C is another top perspective view of the housing of FIG. 5B connected to an exemplary needleless connector, according to some embodiments. [Figure 5E] FIG. 5C is a proximal end view of the housing of FIG. 5B, according to some embodiments. [Figure 6A] FIG. 1 is an expanded view of another exemplary catheter system, according to some embodiments. [Figure 6B] FIG. 6B is a top perspective view of an exemplary housing of the catheter system of FIG. 6A, showing the housing in a closed position, according to some embodiments. [Figure 6C] FIG. 6C is another top perspective view of the housing of FIG. 6B, showing the housing in an open position, according to some embodiments. [Figure 6D] FIG. 6C is another top perspective view of the housing of FIG. 6B coupled to an exemplary needleless connector, according to some embodiments. [Figure 7A] FIG. 1 is an expanded view of another exemplary catheter system, according to some embodiments. [Figure 7B] FIG. 7B is a top perspective view of an exemplary housing of the catheter system of FIG. 7A showing the housing in an open position, according to some embodiments. [Figure 7C] 7C is another top perspective view of the housing of FIG. 7B, showing the housing in a partially closed position, according to some embodiments. [Figure 7D] FIG. 7C is another top perspective view of the housing of FIG. 7B connected to an exemplary needleless connector, according to some embodiments. [Figure 8A] FIG. 1 is a partial cross-sectional view of an exemplary device showing an exemplary outer housing positioned in a proximal position, according to some embodiments. [Figure 8B] FIG. 10 is another partial cross-sectional view of the device showing the outer housing moved to a distal position, according to some embodiments. [Figure 8C] FIG. 10 is another partial cross-sectional view of the device showing the outer housing moved back to the proximal position, according to some embodiments. [Figure 8D] FIG. 8B is a top perspective view of an exemplary first mandrel of the ratchet mechanism of the apparatus of FIG. 8A, according to some embodiments. [Figure 8E] FIG. 8B is a top perspective view of an exemplary second mandrel of the apparatus of FIG. 8A, according to some embodiments. [Figure 8F] FIG. 8E is a top perspective view of the example ratchet wheel of FIG. 8D showing the example pawl in a relaxed position, according to some embodiments. [Figure 8G] FIG. 8E is a top perspective view of the ratchet wheel of FIG. 8D, showing the gripped position, according to some embodiments. [Figure 9A] 2B is a top perspective view of the device of FIG. 2A showing the device in a retracted position, according to some embodiments. [Figure 9B] 2B is a top perspective view of the device of FIG. 2A showing the housing and body sliding axially relative to one another to move the device from a retracted position to an extended position, according to some embodiments. FIG. [Figure 9C] 2B is a top perspective view of the device of FIG. 2A showing the device in an extended position, according to some embodiments. [Figure 9D] 2B is a side view of the device of FIG. 2A showing the device in an extended position, according to some embodiments. [Figure 9E] 2B is a cross-sectional view of the device of FIG. 2A showing the device in an extended position, according to some embodiments. [Figure 9F] 2B is a cross-sectional view of the device of FIG. 2A showing the device in a retracted position, according to some embodiments. [Figure 10A] 2B is an enlarged top perspective view of a portion of the device of FIG. 2A showing the housing and body in a first position, according to some embodiments. [Figure 10B]2B is an enlarged top perspective view of a portion of the device of FIG. 2A showing the housing and body in a second position, according to some embodiments. [Figure 10C] 2B is an enlarged top perspective view of a portion of the device of FIG. 2A, showing the device locked in a retracted position, according to some embodiments. [Figure 10D] 2B is an enlarged top perspective view of a portion of the device of FIG. 2A showing the housing and body in a third position, according to some embodiments. [Figure 10E] 2B is an enlarged top perspective view of a portion of the device of FIG. 2A showing the housing and body in a fourth position, according to some embodiments. [Figure 10F] 2B is an enlarged top perspective view of a portion of the device of FIG. 2A showing the housing and body in a fifth position, according to some embodiments. [Figure 10G] 2B is an enlarged top perspective view of a portion of the device of FIG. 2A, showing the device in a retracted position, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0021] Referring now to FIG. 1 , an exemplary catheter system 14 is shown, according to some embodiments. In some embodiments, the catheter system 14 may include a catheter assembly 16. In some embodiments, the catheter assembly 16 may include a catheter adapter 18 and a catheter 20 extending distally from the catheter adapter 18. In some embodiments, the catheter adapter 18 may include a side port 22 in fluid communication with a lumen of the catheter adapter 18. In some embodiments, the catheter adapter 18 may include a proximal end 23, a distal end 24, and a lumen extending therebetween. In some embodiments, the catheter 20 may include a PIVC, PICC, or midline catheter.

[0022] In some embodiments, the catheter assembly 16 may be movably connected to a needle assembly, which may include a needle hub 26 and an introducer needle 28. In some embodiments, the introducer needle 28 may include a sharpened distal tip 30. In some embodiments, the proximal end of the introducer needle 28 may be fixed within the needle hub 26. In some embodiments, the introducer needle 28 may extend through the catheter 20 when the catheter assembly 16 is in an insertion position ready for insertion into a patient's blood vessel, as shown in FIG. 1 , for example. In some embodiments, in response to the introducer needle 28 being inserted into a patient's blood vessel, a flashback of blood may flow through the sharpened distal tip 30 of the introducer needle 28 and may be visible to a physician between the introducer needle 28 and another location within the catheter 20 and / or catheter assembly 16.

[0023] In some embodiments, in response to confirming via blood flashback that the catheter 20 is positioned within the patient's blood vessel, the needle assembly may be removed from the catheter assembly 16. In some embodiments, when the needle assembly is connected to the catheter assembly 16, the introducer needle 28 of the needle assembly may extend through a septum disposed within the lumen of the catheter adapter 18.

[0024] In some embodiments, the catheter system 14 may include an extension set 32, which may include extension tubes 34 and / or clamps (not shown). In some embodiments, the distal end of the extension tubes 34 may be integral with the catheter adapter 18. For example, the extension tubes 34 may be integral with the side ports 22 of the catheter adapter 18. In some embodiments, the extension tubes 34 may be movably connected to the catheter adapter 18. In some embodiments, a clamp may selectively block the extension tubes 34 to prevent the flow of blood or other fluids through the extension tubes 34.

[0025] In some embodiments, the extension set 32 ​​may include an adapter 38 connected to the proximal end of the extension tube 34. In some embodiments, the adapter 38 may include a Y-adapter or another suitable adapter. In some embodiments, a device 40 may be connected to the adapter 38. In some embodiments, the device 40 may be used to connect the catheter system 14 to a medical device for administering fluids or drawing blood. In some embodiments, the medical device may include an infusion bag, a syringe, or any other suitable medical device. In some embodiments, the device 40 may be configured to prevent contamination of connectors within the device 40, as described in more detail below.

[0026] In some embodiments, the device 40 may be used with the catheter system 14 of Figure 1 or any other suitable catheter system. In some embodiments, the catheter system 14 may be integrated with an integrated extension tube, such as, for example, the BD NEXIVA™ Closed IV Catheter System, the BD NEXIVA™ DIFFUSICS™ Closed IV Catheter System, the BD PEGASUS™ Safety Closed IV Catheter System, or another integrated catheter system.

[0027] 2A-3C, device 40 may comprise one or more of the following: body 42, spring 44, and housing 46. In some embodiments, housing 46 may comprise inner portion 46a, which may be connected to outer portion 46b. The outer portion has been moved to FIGS. 1-2C for illustrative purposes, but is shown in FIGS. 3A-3C, according to some embodiments. In some embodiments, body 42 may comprise a distal end 48, a proximal end 50, and a lumen 52 extending through distal end 48 and proximal end 50. In some embodiments, proximal end 50 of body 42 may comprise a connector 54. In some embodiments, connector 54 may comprise a male or female luer connector 54 with a luer-strip or luer-lock feature configured to connect connector 54 to a medical device, such as medical device 102 shown in FIGS. 4-7 or another suitable medical device.

[0028] In some embodiments, connector 54 may comprise any suitable needleless connector. An exemplary needleless connector may be described in U.S. Patent No. 8,066,670, filed November 5, 2007, entitled "Vascular Access Device Septum Venting," which is incorporated herein by reference. In some embodiments, the needleless connector may comprise a SMARTSITE™ needleless connector offered by Becton, Dickinson, and Company.

[0029] In some embodiments, the connector 54 may comprise a body 55, a septum 56 disposed within the body, and an inner blunt cannula 58. In some embodiments, the septum 56 may comprise a split septum. In some embodiments, the inner blunt cannula 58 may provide an inner fluid path 60 in fluid communication with the lumen 52 of the body 42. In some embodiments, an access luer of a medical device, such as an infusion set, may contact the proximal end 62 of the septum 56 and open the inner fluid path 60. In some embodiments, when the access luer is removed, the septum 56 may return to cover the inner blunt cannula 58 and once again close the inner fluid path 60. In some embodiments, the proximal end 62 may comprise a generally flat proximal surface 64, which may facilitate wiping or scrubbing the proximal end 62. In some embodiments, the septum 56 may include a slit 65 .

[0030] In some embodiments, connector 54 and proximal end 50 may be integrally molded as a single unit. In some embodiments, connector 54 may connect to proximal end 50 via a luer connector, which may include a luer-slip feature, a luer-lock feature (e.g., as shown in FIG. 3), or another suitable connector.

[0031] In some embodiments, the distal end 48 of the body 42 may include a luer connector 66 or another suitable connector, which may be connected to the catheter assembly 16. In some embodiments, the luer connector 66 may include a slip or threaded male luer connector. In some embodiments, the distal end 48 of the body 42 may be connected to an adapter 38, which may include a female luer adapter.

[0032] In some embodiments, the housing 46 may be movable relative to the connector 54. In some embodiments, the connector 54 may be disposed within the housing 46 when the housing 46 is disposed in a proximal position. In some embodiments, the connector 54 may be disposed proximal to the housing 46 in response to movement of the housing 46 from the proximal position to the distal position. In some embodiments, the device 40 may not include the spring 44, and the housing 46 may be manually returned to the proximal position and / or moved to the distal position.

[0033] In some embodiments, the inner portion 46a may be connected to the outer portion 46b at one or more flanges 76. In some embodiments, the inner portion 46a and the outer portion 46b may be integrally molded or co-molded as a single unit.

[0034] In some embodiments, housing 46 may be connected to proximal end 68 of spring 44. In some embodiments, connector 54 may be sealed within housing 46. In some embodiments, distal end 70 of spring 44 may be connected to body 42. In some embodiments, housing 46 may include flap 71, which may include antimicrobial compound 73. In some embodiments, housing 46 may not include flap 71.

[0035] As an example, one or more of the following: body 55, flap 71, and housing 46 may be comprised of a thermoplastic material that may include functional moieties, such as fluoro or silicone, that may be prone to migration onto the surface of the thermoplastic material. The functional moieties on the surface of the thermoplastic material may potentially reduce microbial adhesion by creating a hydrophobic and slippery environment. In another embodiment, one or more of the following: body 55, housing 46, and flap 71 may be provided with an antimicrobial compound 73, which may be provided as an antimicrobial coating. Furthermore, in another embodiment, flap 71 may include a pad or fabric, which may be provided with the antimicrobial compound 73.

[0036] In certain embodiments, antimicrobial agents used as the antimicrobial compound contained in the fabric or antimicrobial coating of pad or flap 71 may include chlorhexidine diacetate (CHA) and chlorhexidine gluconate (CHG). However, any other antimicrobial agent widely reported in the literature may be used. Non-limiting examples of antimicrobial coatings and related application methods may be found in U.S. Pat. No. 8,691,887, entitled "Antimicrobial Coating Composition," filed June 2, 2009; U.S. Pat. No. 8,754,020, entitled "Antimicrobial Lubricating Composition," filed April 22, 2013; U.S. Pat. No. 4,731,402, entitled "Method for Preparing Antithrombogenic / Antibiotic Polymeric Plastic Materials," filed August 30, 1985; and U.S. Pat. No. 4,442,133, entitled "Antibiotic Conjugation to Vascular Prostheses and Other Implants," filed February 22, 1982. No. 3, U.S. Pat. No. 4,678,660, filed August 14, 1985, entitled "Thermoplastic Polyurethane Anticoagulant Incorporated Coating," U.S. Pat. No. 5,013,306, filed March 21, 1990, entitled "Anti-infective and Anti-thrombogenic Medical Articles and Methods for Preparing the Same," U.S. Pat. No. 6,261,271, filed January 13, 1998, entitled "Anti-infective and Anti-thrombogenic Medical Articles and Methods for Preparing the Same," and U.S. Pat. No. 5,322,659, filed September 21, 1990, entitled "Method for Rendering a Surface of a Material Anti-thrombogenic and / or Anti-infective," each of which is incorporated herein by reference.

[0037] In some embodiments, when housing 46 is disposed in a proximal position, for example, as shown in Figures 2A and 3A, flap 71 may cover connector 54, antimicrobial compound 73 may contact connector 54, and spring 44 may be uncompressed. In some embodiments, in response to movement of flap 71 from a closed position, for example, as shown in Figure 2A, to an open position, for example, as shown in Figure 2B or 2C, flap 71 may automatically wipe connector 54. In some embodiments, in response to flap 71 contacting and / or wiping septum 56, antimicrobial compound 73 may be transferred from flap 71 to septum 56.

[0038] In some embodiments, in response to movement of housing 46 from a proximal position to a distal position, spring 44 may be compressed and flap 71 may open. In some embodiments, the distal position may comprise a first distal position, e.g., as shown in Figures 2B and 3B, or a second distal position, e.g., as shown in Figures 2C and 3C.

[0039] In some embodiments, device 40 may include a support structure 72, which may include one or more extension guides 74. In some embodiments, housing 46 may include one or more flanges 76. In some embodiments, flanges 76 may be arranged to move distally along extension guides 74 in response to movement of housing 46 from a proximal position to a distal position.

[0040] In some embodiments, the extension guide 74 may include one or more stops 78. In some embodiments, the flange 76 may be configured to move distally along the extension guide 74 when the flange 76 is proximal and spaced from the stop 78. In some embodiments, for example, as shown in FIG. 2B , the housing 46 and support structure 72 may be configured to move together distally in response to movement of the housing 46 distally and the flange 76 contacting the stop 78. For example, in response to movement of the housing 46 distally and the flange 76 contacting the stop 78, the housing 46 and support structure 72 may be configured to move together distally from the position shown in FIG. 2B to the position shown in FIG. 2C . In some embodiments, the flange 76 may facilitate holding or grasping the housing 46 by the physician.

[0041] In some embodiments, the proximal end 80 of the support structure 72 may include an opening 82. In some embodiments, the diameter of the opening 82 may be smaller than the diameter of the flap 71, which may prevent the flap 71 from opening and / or fully opening when the housing 46 is disposed in the proximal position.

[0042] In some embodiments, as shown in Figures 2C and 3C, connector 54 may be exposed for connection to an access lumen of a medical device. In some embodiments, as shown in Figures 2C and 3C, threading 84 may be exposed. In response to connection of an access luer of a medical device to connector 54, flap 71 may be maintained in a fully open position, as shown in Figures 2C and 3C, for example. In some embodiments, in response to the physician releasing his or her hold on housing 46 and / or support structure 72, spring 44 may return housing 46 and / or support structure 72 to a proximal position.

[0043] 4A-4E, in some embodiments, a housing 86 for sterilizing a connector 88 may include a body 90, which may include a distal end 92, a proximal end 94, and a lumen 96 extending through the distal end 92 and the proximal end 94. In some embodiments, the distal end 92 may be configured to receive the connector 88. In some embodiments, the connector 88 may include or correspond to the connector 54 discussed with respect to FIGS. 2A-3C. In some embodiments, the proximal end 94 may include an access opening 98 configured to receive a medical device 102, such as an infusion set or syringe. In some embodiments, the housing 86 may be used with the catheter system 14 of FIG. 1 or any other catheter system.

[0044] In some embodiments, the housing 86 may include a cover 100 connected to the proximal end 94 of the body 90 and covering the opening 98. In some embodiments, the cover 100 may include the antimicrobial compound 73. In some embodiments, in response to removal of the medical device 102 from the access opening 98, the cover 100 may automatically close, and the antimicrobial compound 73 may be positioned to contact the proximal end of the connector 88. In some embodiments, the cover 100 may be spring-loaded, which may facilitate closing the cover 100 in response to removal of the medical device 102 from the access opening 98. In some embodiments, the cover 100 may include a torsion spring. In some embodiments, the connector 88 may be encased or sealed within the housing 86 when the cover 100 is closed.

[0045] In some embodiments, in response to movement of the cover 100 from, for example, a closed position as shown in FIG. 4B to, for example, an open position as shown in FIG. 4C , the cover 100 may wipe the connector 88. In some embodiments, in response to movement of the cover 100 from an open position to a closed position, the cover 100 may wipe the connector 88. In some embodiments, a medical device 102 may be connected to the connector 88 when the cover 100 is in the open position. In some embodiments, automatically closing the cover 100 and wiping the connector 88 in response to removal of the medical device from the access opening 98 may protect the connector 88 from microbial contamination.

[0046] In some embodiments, the cover 100 may be connected to the proximal end 94 at a pivot 104. In some embodiments, the cover 100 may be arranged to rotate about the pivot 104 between an open position and a closed position. In some embodiments, the cover 100 may be arranged to rotate about the pivot 104 on an axis generally parallel to a central axis 106 of the body 90. In some embodiments, the pivot 104 may comprise a pin or another rotation mechanism. In some embodiments, in response to opening the cover 100, a new cleaning pad may be exposed and an old cleaning pad may be removed.

[0047] 5A-5E, in some embodiments, a housing 108 for flushing a connector 88 may comprise a body 110, which may comprise a distal end 112, a proximal end 114, and a lumen 116 extending through the distal end 112 and the proximal end 114. In some embodiments, the distal end 112 may be configured to receive the connector 88. In some embodiments, the proximal end 114 may comprise an access opening 118 configured to receive a medical device 102, such as an injection set or syringe. In some embodiments, the access opening 118 may be spaced from a proximal end 119 of the connector 88 such that the medical device 102 and the connector 88 connect directly together. In some embodiments, the housing 108 may comprise or correspond to the housing 86, as described with respect to FIGS. 4A-4E.

[0048] In some embodiments, the housing 108 may include a cover 120 connected to the body 110 and covering the opening 118. In some embodiments, the cover 120 may include the antimicrobial compound 73. In some embodiments, in response to removal of the medical device 102 from the access opening 118, the cover 120 may automatically close, and the antimicrobial compound 73 may be positioned to contact the proximal end 119 of the connector 88. In some embodiments, the cover 120 may be spring-loaded, which may facilitate closing the cover 120 in response to removal of the medical device 102 from the access opening 118. In some embodiments, the cover 120 may include a torsion spring. In some embodiments, the connector 88 may be encased or sealed within the housing 86 when the cover 120 is closed.

[0049] In some embodiments, in response to movement of the cover 120 from, for example, a closed position shown in FIG. 5B to, for example, an open position shown in FIG. 5C , the cover 120 may wipe the connector 88. In some embodiments, in response to movement of the cover 120 from the open position to the closed position, the cover 120 may wipe the connector 88. In some embodiments, the medical device 102 may be connected to the connector 88 when the cover 120 is in the open position. In some embodiments, the automatic closing of the cover 120 and wiping the connector 88 in response to removal of the medical device from the access opening 98 may protect the connector 88 from microbial contamination.

[0050] In some embodiments, the cover 120 may be connected to the body 110 at one or more pivots 122. In some embodiments, the cover 120 may be arranged to rotate about the pivots 122 between an open position and a closed position. In some embodiments, the cover 120 may be arranged to rotate about the pivots 122 between the open position and the closed position on an axis generally perpendicular to a central axis 124 of the body 110. In some embodiments, the pivots 122 may comprise a pin or another rotation mechanism.

[0051] In some embodiments, a first distal arm 128a and a second distal arm 128b (collectively referred to in this disclosure as “distal arms 128”) may extend from a first pivot 122a and a second pivot 122b (collectively referred to in this disclosure as “pivot 122”), respectively. In some embodiments, a first proximal arm 130a and a second proximal arm 130b (collectively referred to in this disclosure as “proximal arms 130”) may be coupled to the cover 120 and may be positioned to connect with the proximal end of the connector 88 when the cover 120 is in the closed position. In some embodiments, a semicircular portion 132 may be positioned between the distal arm 128 and the proximal arm 130. In some embodiments, the semicircular portion 132 may be positioned to fit around the body 110 when the cover is in the open position such that the semicircular portion 132 and the body contact each other and do not create a space between them.

[0052] 6A-6D, in some embodiments, a housing 134 for flushing a connector 88 may include a body 136, which may include a distal end 138, a proximal end 140, and a lumen 142 extending through the distal end 138 and the proximal end 140. In some embodiments, the distal end 138 may be configured to receive the connector 88. In some embodiments, the proximal end 140 may include an access opening 144 configured to receive a medical device 102, such as an injection set or syringe. In some embodiments, the access opening 144 may be spaced apart from the proximal end 119 of the connector 88 such that the medical device 102 and the connector 88 connect directly together. In some embodiments, the housing 134 may include or correspond to the housing 86 described with respect to FIGS. 4A-4E or the housing 108 described with respect to FIGS. 5A-5E.

[0053] In some embodiments, the housing 134 may include a cover 120 connected to the body 136 and covering the access opening 144. In some embodiments, the cover 120 may include an antimicrobial compound 73. In some embodiments, the cover 120 may be configured to automatically close in response to removal of the medical device 102 from the access opening 144, and the antimicrobial compound 73 may be configured to contact the proximal end 119 of the connector 88. In some embodiments, an antimicrobial strip (e.g., antimicrobial strip 170 shown in FIGS. 7A-7D ) may be disposed over the access opening 144. In some embodiments, the cover 120 may be spring-loaded, which may facilitate closing the cover 120 in response to removal of the medical device 102 from the access opening 144. In some embodiments, the connector 88 may be encased or sealed within the housing 134 when the cover 120 is closed.

[0054] In some embodiments, in response to movement of the cover 120 from, for example, a closed position as shown in FIG. 6B to, for example, an open position as shown in FIG. 6C , the cover 120 may wipe the connector 88. In some embodiments, in response to movement of the cover 120 from an open position to a closed position, the cover 120 may wipe the connector 88. In some embodiments, the medical device 102 may be connected to the connector 88 when the cover 120 is in the open position. In some embodiments, the automatic closing of the cover 120 and wiping the connector 88 in response to removal of the medical device from the access opening 144 may protect the connector 88 from microbial contamination.

[0055] In some embodiments, cover 120 may be connected to body 136 at one or more pivots 148. In some embodiments, cover 120 may be arranged to rotate about pivot 148 between an open position and a closed position. In some embodiments, cover 120 may be arranged to rotate about pivot 122 between an open position and a closed position on an axis generally perpendicular to a central axis 149 of body 136. In some embodiments, pivots 148 may each comprise a pin or any other suitable rotation mechanism.

[0056] In some embodiments, the cover 100 may include a distal tab 150 and an L-shaped portion 152 connected to the distal tab 150. In some embodiments, the pivot 148 may be disposed between the distal tab 150 and the L-shaped portion 152. In some embodiments, in response to the depression of the distal tab 150, the L-shaped portion may rise and the access opening 144 may be exposed.

[0057] Referring now to Figures A7-7D, in some embodiments, a housing 154 for flushing a connector 88 may include a body 156, which may include a distal end 158, a proximal end 160, and a lumen 162 extending through the distal end 158 and the proximal end 160. In some embodiments, the housing 154 may include or correspond to one or more of the following: the housing 86 described with reference to Figures 4A-4E, the housing 108 described with reference to Figures 5A-5E, or the housing 134 described with reference to Figures 6A-6D.

[0058] In some embodiments, the body 156 may include a distal piece 166 and a proximal piece 168, which may rotate relative to the distal piece 166. In some embodiments, an antimicrobial strip 170 may be disposed over the access opening 164. In some embodiments, in response to rotation of the proximal piece 168 relative to the distal piece 166, the antimicrobial strip 170 may advance and move across the access opening 164 in a conveyor belt-like manner. In some embodiments, the proximal piece 168 may be rotated in a first direction relative to the distal piece 166, automatically pulling the antimicrobial strip 170 across the proximal end 119 of the connector 88 prior to use of the connector 88. In some embodiments, an aperture 172 in the antimicrobial strip 170 may allow the medical device 102 to access and connect to the connector 88.

[0059] In some embodiments, following disconnection of medical device 102 from connector 88 and removal of medical device 102 from body 156, proximal piece 168 may be rotated in a first direction to automatically pull antimicrobial strip 170 across proximal end 119 and wipe proximal end 119 of connector 88. In some embodiments, antimicrobial strip 170 may comprise antimicrobial compound 73. In some embodiments, a color change in antimicrobial strip 170 may indicate that antimicrobial strip 170 is worn and that housing 154 may be replaced.

[0060] In some embodiments, rotating the distal piece 166 and / or the proximal piece 168 may turn a gear set that translates the rotational movement into movement of the antimicrobial strip 170 across the aperture 172, exposing a new portion of the antimicrobial strip 170. In some embodiments, the gear set may be part of a different mechanism, which may include a crown wheel, pinion gears, sun gears, planetary gears, different shafts, etc., as understood in the art. In some embodiments, in response to rotation of the distal piece 166 and / or the proximal piece 168 in a first direction, the antimicrobial strip 170 may move across the aperture 172.

[0061] 8A-8G, in some embodiments, an apparatus 174 for sterilizing a connector 88 may include an inner housing 176, which may be annular, and an outer housing 178, which may also be annular. In some embodiments, the inner housing 176 may include a proximal opening 179 and may be positioned to receive the connector 88. In some embodiments, the connector 88 may be positioned to snap fit with the inner housing 176. In some embodiments, the outer housing 178 may be movable relative to the inner housing 176 between, for example, a proximal position shown in FIGS. 8A and 8C and a distal position shown in, for example, FIG. 8B. In some embodiments, the outer housing 178 may include one set of teeth 180 .

[0062] In some embodiments, the device 174 may include a ratchet wheel 182, which may include an inner set of teeth 184 and an outer set of teeth 186. In some embodiments, a first mandrel 188 may extend through the ratchet wheel 182 and may include a pawl 190. In some embodiments, a second mandrel 192 may be positioned on the opposite side of the inner housing 176 as the first mandrel 188.

[0063] In some embodiments, the antimicrobial strip 194 may be wrapped around the second mandrel 192 and connected to the first mandrel 188. In some embodiments, the antimicrobial strip 194 may extend beyond the proximal opening 179 of the inner housing 176. In some embodiments, in response to movement of the outer housing 178 between the proximal and distal positions, the pawl 190 may grip the inner set of teeth 184, the inner surface set of teeth 180 may continue to engage the outer set of teeth 186, and the ratchet wheel 182 and first mandrel 188 may rotate such that the antimicrobial strip 194 moves across the proximal opening 179 of the inner housing 176. In some embodiments, the antimicrobial strip 194 may comprise a cloth, tape, or other suitable material. In some embodiments, the antimicrobial strip 194 may comprise the antimicrobial compound 73.

[0064] In some embodiments, in response to movement of the outer housing 178 between the proximal and distal positions, the antimicrobial strip 194 may be wrapped around the first mandrel 188 and / or unwrapped from the second mandrel 192. In some embodiments, the antimicrobial strip 194 may include a plurality of holes positioned to allow the medical device 102 to extend through and connect to the connector 88 for infusion or blood collection. In some embodiments, the distal end of the connector 88 may be connected to the extension tube 34 or adapter 38.

[0065] In some embodiments, the outer housing 178 may include a flap 198. In some embodiments, the flap 198 may open in response to movement of the outer housing 178 between a proximal position and a distal position. In some embodiments, the outer housing 178 may be positioned to encase the connector.

[0066] In some embodiments, the device 174 may include another ratchet wheel 200, which may include an inner set of teeth 184 and an outer set of teeth 186. In some embodiments, a first mandrel 188 may extend through the other ratchet wheel 200. In some embodiments, an antimicrobial strip 194 may be disposed between the ratchet wheel 182 and the other ratchet wheel 200. In some embodiments, the device 174 may include an arm 202 extending through the first mandrel 188. In some embodiments, the first mandrel 188 may be disposed to rotate relative to the arm 202. In some embodiments, the arm 202 may be connected to the inner housing 176.

[0067] 9A , according to some embodiments, the device 40 is shown in a retracted position. In some embodiments, when the device 40 is in the retracted position, the housing 46 may be in a proximal position. In some embodiments, the housing 46 and the body 42 may be arranged to slide axially relative to one another to move the device 40 from a retracted position, in which the connector 54 is enclosed within the housing 46, to an extended position, in which the connector 54 is exposed at a proximal end of the housing 46. For example, the housing 46 may slide axially distally from the retracted position, and / or the body 42 may slide axially proximally from the retracted position. In some embodiments, the housing 46 may slide axially distally to open the flap 71, and after the flap 71 is opened, the connector 54 may move proximally and out of the housing 46. In some embodiments, the housing 46 may be disposed in a distal position when the device 40 is in the extended position.

[0068] In some embodiments, device 40 may include spring 210, which may have a proximal end and a distal end. In some embodiments, the proximal end of spring 210 may be connected to body 42. In some embodiments, the distal end of spring 210 may urge distally against cam body 212 of device 40. In some embodiments, the inner surface of outer portion 46b may include one or more rails 214. In some embodiments, the outer surface of cam body 212 may include one or more slots 216, which may extend completely or partially through cam body 212. In some embodiments, rails 214 may be disposed within slots 216, which may prevent rotation of cam body 212 when device 40 is in the retracted position, as shown in FIG. 9A .

[0069] 9B, in some embodiments, as the body 42 moves from the retracted position to the extended position, the body 42 may slide axially in the proximal direction and / or the housing 46 may slide axially in the distal direction. In these embodiments, the rails 214 may slide within the slots 216. In some embodiments, as the housing 46 slides axially in the distal direction, the flange 76 may move along the extension guide 74 or the flange 76, and the support structure 72 may move together in the distal direction.

[0070] 9C-9E, device 40 is shown in an extended position, according to some embodiments. In some embodiments, in response to housing 46 and body 42 sliding axially toward one another, rail 214 may be removed from slot 216, which may cause cam body 212 to rotate. In some embodiments, one or more angled surfaces of cam body 212 and / or one or more teeth 218 connected to body 42 may rotate cam body 212, which may be urged distally by a spring. In some embodiments, cam body 212 may rotate until rail 214 contacts stop surface 220 of cam body 212, as shown in FIG. 9C, for example.

[0071] In some embodiments, device 40 may be locked in the extended position. In some embodiments, rail 214 and / or teeth 218 may engage cam body 212 when device 40 is in the extended position, which may lock device 40 in the extended position. In some embodiments, in response to movement of body 42 beyond the proximally extended position, device 40 may be unlocked and positioned to return to the retracted position. For example, rail 214 may no longer contact stop surface 220 and cam body 212 may rotate such that rail 214 can slide through slot 216.

[0072] 9F, in some embodiments, when device 40 is in the retracted position, flap 71 may cover connector 54 and / or antimicrobial compound 73 may contact connector 54. In some embodiments, in response to movement of flap 71 from, for example, a closed position shown in FIG. 9F to, for example, an open position shown in FIGS. 9C-9E, flap 71 may automatically wipe connector 54. In some embodiments, in response to contact and / or wiping of flap 71 with septum 56, antimicrobial compound 73 may be transferred from flap 71 to septum 56.

[0073] 10A-10G, according to some embodiments, a sequence of positions of device 40 is shown in order from Figure 10A to 10G. As shown in Figure 10A, in some embodiments, rail 214 may be partially removed from slot 216 in response to housing 46 and body 42 sliding axially relative to one another toward a first position.

[0074] 10B, in some embodiments, in response to housing 46 and body 42 sliding axially relative to one another toward the second position, rail 214 may be removed from slot 216, which may rotate cam body 212. In some embodiments, angled surface 22 of cam body 212 and / or one or more teeth associated with body 42 may rotate cam body 212, which may be urged distally by a spring.

[0075] 10C, in some embodiments, cam body 212 may rotate until rail 214 contacts a stop surface on cam body 212. In some embodiments, rail 214 and / or teeth 218 may engage with cam body 212 when device 40 is in the extended position, which may lock device 40 in the extended position.

[0076] 10D-10E, in some embodiments, in response to movement of body 42 beyond the proximally extended position or movement of connector 54 further from housing 46 than in the extended position, device 40 may be unlocked and positioned to return to the retracted position. For example, rail 214 no longer contacts stop surface 220, and cam body 212 may rotate, allowing rail 214 to slide through slot 216, as shown in FIGS. 10F-10G, for example.

[0077] 9-10 illustrate an exemplary mechanism for moving device 40 from a retracted position to an extended position and back to the retracted position, according to some embodiments. All examples and conditional language described herein are intended for educational purposes to assist the reader in understanding the concepts contributed by the inventors to further the invention and the art, and should be construed as without limitation to such specifically described examples and conditions. While embodiments of the invention have been described in detail, it should be understood that various modifications, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention.

Claims

1. 1. A housing for disinfecting a vascular access device connector, comprising: a body having a distal end, a proximal end, and a lumen extending through the distal end and the proximal end, the distal end being positioned to receive a vascular access device connector and the proximal end being positioned to receive an infusion device; a cover connected to a proximal end of the body at a pivot defining an axis generally parallel to a central axis of the body, the cover comprising an antimicrobial compound and spring biased to close; In response to removal of the infusion device from the access opening, the cover automatically rotates from an open position to a closed position so that the antimicrobial compound contacts and scrubs the proximal end of the vascular access device connector; and The housing, wherein the cover comprises a movable portion having a first arm and a second arm extending from a pivot, and a semicircular portion disposed between the first arm and the second arm, the semicircular portion being disposed to fit around the body when the cover is in an open position and to uniformly contact the connector when the cover is in a closed position.

2. A housing as described in claim 1, wherein the semicircular portion and arm form a hinge assembly that maintains axial alignment of the body and cover during rotation.

3. 10. The housing of claim 1, wherein the cover comprises a distal tab and an L-shaped portion connected to the distal tab, and depression of the distal tab causes the L-shaped portion to rise and expose the opening.

Images