Automatic disinfection of vascular access device connectors

Abstract

The invention relates to automatic disinfection of vascular access device connectors. The disclosure also relates to a coupling device for coupling a vascular access device to a medical device, which may include a body, a spring, and a housing. The body may include a distal end, a proximal end, and a lumen extending through the distal end and the proximal end. The proximal end of the body may include a connector. The housing may be coupled to the proximal end of the spring and may enclose the connector. The distal end of the spring may be coupled to the body. The housing may include a flap, which may include an antibacterial compound. When the housing is disposed in the proximal position, the tab may cover the connector, the antimicrobial compound may contact the connector, and the spring may not be compressed. In response to movement of the housing from the proximal position to the distal position, the spring may be compressed and the flap may open.

Description

[0001] This application is a divisional application of the Chinese patent application with international application number PCT / US2020 / 033964, Chinese application number 202080040209.4, application date May 21, 2020, and name “Automatic Disinfection of Vascular Access Device Connectors”. Technical Field

[0002] The present disclosure relates to the technical field of medical devices. Background Art

[0003] Intravenous catheters are commonly used for various infusion therapies. For example, intravenous catheters can be used to infuse fluids, such as saline solutions, various medications, and total parenteral nutrition, into a patient. Intravenous catheters can also be used to draw blood from a patient.

[0004] Common types of IV catheters are peripheral intravenous catheters ("PIVC"), peripherally inserted central catheters ("PICC"), and midline catheters. IV catheters may include an "over-the-needle" catheter that can be mounted on an introducer needle with a sharp distal tip. The sharp distal tip can be used to pierce the patient's skin and vasculature. The IV catheter can be inserted into the vasculature after the needle has pierced the vasculature. The needle and IV catheter are typically inserted through the skin into the patient's vasculature at a slight angle, with the bevel of the needle facing away from the patient's skin. Once placement of the needle in the vasculature is confirmed, the clinician can temporarily occlude blood flow in the vasculature and retract the needle, leaving the IV catheter in place for future blood draws and / or infusions.

[0005] Needleless connectors can be used to connect intravenous catheters to medical devices used to administer fluids or draw blood. Medical devices can include infusion bags, syringes, etc. Often, during infusion therapy, the proximal end of the needleless connector is exposed to non-sterile surfaces. When the proximal end of the needleless connector is exposed, it can become contaminated by the clinician, the patient, bedding, tables, floor surfaces, or any number of other sources of contamination.

[0006] Exposed needleless connectors are potential sites for intraluminal microbial contamination, which can lead to catheter-related bloodstream infections (“CRBSIs”). CRBSIs are a significant cause of morbidity and excessive healthcare costs, as approximately 250,000 CRBSIs occur annually in U.S. intensive care units. Despite guidelines to help reduce healthcare-associated infections, CRBSIs continue to plague our healthcare system. Needleless connectors have been identified as a source of contamination that leads to CRBSIs during infusions.

[0007] Current standards recommend sterilizing needleless connectors with vigorous mechanical scrubbing and drying time before each use and recommend the use of passive sterilization caps. Compliance with sterilization protocols for needleless connectors varies by clinician and is further complicated by different manufacturers requiring different lengths of scrubbing and drying times, which often results in incomplete sterilization of needleless connectors and increases the risk of bloodstream infection. Currently, the use of passive sterilization caps is not common, often due to differences in hospital policies, clinician compliance with cap use protocols, and increased clinician time to locate and place sterilization caps.

[0008] 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 embodiments described herein may be practiced. Summary of the invention

[0009] In some embodiments, a device for coupling 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 other suitable connector coupled to the vascular access device.

[0010] In some embodiments, the housing can be coupled to the proximal end of the spring and can surround the connector. In some embodiments, the distal end of the spring can be coupled to the body. In some embodiments, the housing can include a wing that can include an antimicrobial compound. In some embodiments, when the housing is disposed in the proximal position, the wing can cover the connector, the antimicrobial compound can contact the connector, and the spring can be uncompressed. In some embodiments, in response to the housing moving from the proximal position to the distal position, the spring can be compressed and the wing can be opened.

[0011] In some embodiments, the device may include a support structure that may include one or more elongated guides. In some embodiments, the housing may include one or more flanges. In some embodiments, in response to the housing moving from a proximal position to a distal position, the flange may be configured to move along the elongated guide in a distal direction.

[0012] In some embodiments, the elongated guide may include one or more stops. In some embodiments, the flange may be configured to move in a distal direction along the guide when the flange is proximal to and spaced from the stop. In some embodiments, in response to movement of the housing in the distal direction and the flange contacting the stop, the housing and the support structure may be configured to move together in the distal direction.

[0013] 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 fin, which may prevent the fin from fully opening when the housing is disposed in the proximal position.

[0014] In some embodiments, an apparatus for sterilizing a vascular access device connector may include an inner shell and an outer shell. In some embodiments, the inner shell may include a proximal opening and may be configured to receive the vascular access device connector. In some embodiments, the outer shell may be movable relative to the inner shell between a proximal position and a distal position. In some embodiments, the outer shell may include a set of teeth.

[0015] In some embodiments, the device may include a ratchet wheel that may include a set of internal teeth and a set of external teeth. In some embodiments, the first spindle may extend through the ratchet wheel and may include a pawl. In some embodiments, the second spindle may be disposed on a side of the inner housing opposite to the first spindle.

[0016] In some embodiments, the antimicrobial strip can be wrapped around the second spindle and coupled to the first spindle. In some embodiments, the antimicrobial strip can extend over the proximal opening of the inner shell. In some embodiments, in response to movement of the outer shell between the proximal position and the distal position, the pawl can snap onto the set of inner teeth, the set of teeth on the inner surface can continuously engage the set of outer teeth, and the ratchet and spindle can rotate such that the antimicrobial strip moves across the proximal opening of the inner shell.

[0017] In some embodiments, the antimicrobial strip can be wrapped around the first mandrel and / or unwound from the second mandrel in response to movement of the housing between the proximal position and the distal position. In some embodiments, the antimicrobial strip can include a plurality of apertures configured to allow a medical device to be coupled to a vascular access device connector for infusion or blood withdrawal.

[0018] In some embodiments, the housing can include a flap. In some embodiments, the flap can be opened in response to movement of the housing between the proximal position and the distal position. In some embodiments, the housing can be configured to surround the vascular access device connector.

[0019] In some embodiments, the device may include another ratchet. In some embodiments, the first spindle may extend through the other ratchet. In some embodiments, the antimicrobial strip may be disposed between the ratchet and the other ratchet. In some embodiments, the device may include an arm extending through the spindle. In some embodiments, the spindle may be configured to rotate relative to the arm. In some embodiments, the arm may be coupled to the inner housing.

[0020] The purpose and advantages of the embodiment will be realized and obtained at least by the elements, features and combinations particularly pointed out in the claims.It should be understood that the foregoing summary and the following detailed description are exemplary and explanatory, rather than limiting on the invention claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which: Figure 1 is an upper perspective view of an example catheter system according to some embodiments; Figure 2A is an upper perspective view of an example device for coupling a catheter system to a medical device showing an example housing of the device disposed in a proximal position according to some embodiments; Figure 2B According to some embodiments Figure 2A another upper perspective view of the device showing the housing disposed in a first distal position; Figure 2C According to some embodiments Figure 2A another upper perspective view of the device of claim 1, showing the housing disposed in a second distal position; Figure 3A According to some embodiments Figure 2A A cross-sectional view of a device showing a housing disposed in a proximal position and including an outer portion; Figure 3B According to some embodiments Figure 2B A cross-sectional view of the device showing the housing disposed in a first distal position; Figure 3C According to some embodiments Figure 2C a cross-sectional view of the device showing the housing disposed in a second distal position; Figure 4A is an exploded view of another example catheter system according to some embodiments; Figure 4B According to some embodiments Figure 4A An upper perspective view of an example housing of a catheter system of FIG. 1 , showing the housing in a closed position; Figure 4C According to some embodiments Figure 4B Another upper perspective view of the housing showing the housing in an open position; Figure 4D According to some embodiments Figure 4B Another upper perspective view of a housing coupled to an example needleless connector; Figure 4E is a bottom view of an example cover according to some embodiments; Figure 5A is an exploded view of another example catheter system according to some embodiments; Figure 5B According to some embodiments Figure 5A An upper perspective view of an example housing of a catheter system of FIG. 1 , showing the housing in a closed position; Figure 5C According to some embodiments Figure 5B Another upper perspective view of the housing showing the housing in an open position; Figure 5D According to some embodiments Figure 5B Another upper perspective view of a housing coupled to an example needleless connector; Figure 5E According to some embodiments Figure 5B A proximal view of the housing; Fig. 6A is an exploded view of another example catheter system according to some embodiments; Figure 6B According to some embodiments Fig. 6A An upper perspective view of an example housing of a catheter system of FIG. 1 , showing the housing in a closed position; Figure 6C According to some embodiments Figure 6B Another upper perspective view of the housing showing the housing in an open position; Fig.6D According to some embodiments Figure 6B Another upper perspective view of a housing coupled to an example needleless connector; Fig. 7A is an exploded view of another example catheter system according to some embodiments; Figure 7B According to some embodiments Fig. 7A An upper perspective view of an example housing of a catheter system of FIG. 1 , showing the housing in an open position; Figure 7C According to some embodiments Figure 7B Another upper perspective view of the housing of , showing the housing in a partially closed position; Fig.7D According to some embodiments Figure 7B Another upper perspective view of a housing coupled to an example needleless connector; Fig. 8A is a partial cross-sectional view of an example device according to some embodiments, showing an example housing disposed in a proximal position; Figure 8B According to some embodiments Fig. 8AAnother partial cross-sectional view of the device, with the housing moved to a distal position; Figure 8C According to some embodiments Fig. 8A another partial cross-sectional view of the device showing the housing moved back to the proximal position; Fig.8D According to some embodiments Fig. 8A An upper perspective view of an exemplary first spindle of a ratchet mechanism of a device; Fig. 8E According to some embodiments Fig. 8A An upper perspective view of an exemplary second mandrel of the apparatus; Figure 8F According to some embodiments Fig.8D An upper perspective view of an exemplary ratchet showing an exemplary pawl in a relaxed position; Figure 8G According to some embodiments Fig.8D An upper perspective view of the ratchet wheel shown in a locked position; Fig.9A According to some embodiments Figure 2A An upper perspective view of the device of FIG. 1 , showing the device in a retracted position; Fig. 9B According to some embodiments Figure 2A An upper perspective view of the device of , showing the housing and the body sliding axially toward each other to move the device from a retracted position to an extended position; Fig. 9C According to some embodiments Figure 2A An upper perspective view of the device of FIG. 1 , showing the device in an extended position; Fig.9D According to some embodiments Figure 2A A side view of the device showing the device in an extended position; Fig.9E According to some embodiments Figure 2A A cross-sectional view of the device showing the device in an extended position; Fig.9F According to some embodiments Figure 2A A cross-sectional view of the device showing the device in a retracted position; Fig. 10A According to some embodiments Figure 2A an enlarged upper perspective view of a portion of the device showing the housing and body in a first position; Fig. 10B According to some embodiments Figure 2A an enlarged upper perspective view of a portion of the device showing the housing and body in a second position; Fig. 10C yes Figure 2A an enlarged upper perspective view of a portion of the device of , showing the device locked in the extended position; Fig. 10D According to some embodiments Figure 2A an enlarged upper perspective view of a portion of the device showing the housing and body in a third position; Fig.10E According to some embodiments Figure 2A an enlarged upper perspective view of a portion of the device showing the housing and body in a fourth position; Fig.10F According to some embodiments Figure 2A an enlarged upper perspective view of a portion of the device showing the housing and body in a fifth position; and Figure 10G According to some embodiments Figure 2A An enlarged upper perspective view of a portion of the device showing the device in a retracted position. DETAILED DESCRIPTION

[0022] Reference now Figure 1 , an example catheter system 14 is illustrated, 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 the 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, a PICC, or a midline catheter.

[0023] In some embodiments, the catheter assembly 16 can be removably coupled to a needle assembly, which can include a needle hub 26 and an introducer needle 28. In some embodiments, the introducer needle 28 can include a sharp distal tip 30. In some embodiments, the proximal end of the introducer needle 28 can be fixed within the needle hub 26. In some embodiments, when the catheter assembly 16 is in an insertion position ready for insertion into the patient's vascular system, the introducer needle 28 can extend through the catheter 20, for example, as shown in FIG. Figure 1 In some embodiments, in response to inserting the introducer needle 28 into the patient's vasculature, blood flashback may flow through the sharp distal tip 30 of the introducer needle 28 and the clinician may observe the blood flashback between the introducer needle 28 and the catheter 20 and / or at another location within the catheter assembly 16.

[0024] In some embodiments, in response to confirming that catheter 20 is located within the patient's vasculature via blood flashback, the needle assembly can be removed from catheter assembly 16. In some embodiments, when the needle assembly is coupled to catheter assembly 16, the introducer needle 28 of the needle assembly can extend through a septum disposed within the lumen of catheter adapter 18.

[0025] In some embodiments, the catheter system 14 may include an extension set 32, which may include an extension tube 34 and / or a clamp (not shown). In some embodiments, the distal end of the extension tube 34 may be integrated with the catheter adapter 18. For example, the extension tube 34 may be integrated with the side port 22 of the catheter adapter 18. In some embodiments, the extension tube 34 may be removably coupled to the catheter adapter 18. In some embodiments, the clamp may selectively close the extension tube 34 to prevent blood or another fluid from flowing through the extension tube 34.

[0026] In some embodiments, the extension group 32 may include an adapter 38 coupled to the proximal end of the extension tube 34. In some embodiments, the adapter 38 may include a Y-shaped adapter or another suitable connector. In some embodiments, a device 40 may be coupled to the adapter 38. In some embodiments, the device 40 may be used to connect the catheter system 14 to a medical device for fluid administration or blood drawing. 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 the connector within the device 40, as will be explained in further detail.

[0027] In some embodiments, the device 40 may be used with Figure 1 In some embodiments, the catheter system 14 can be integrated with an integrated extension tube, such as BDNEXIVA™ closed intravenous catheter system, BDNEXIVA™DIFFUSICS™ closed intravenous catheter system, BDPEGASUS™ safe closed intravenous catheter system, or other integrated catheter systems.

[0028] Reference now Figure 2A -3C, the device 40 may include one or more of the following: a body 42, a spring 44, and a housing 46. In some embodiments, the housing 46 may include an inner portion 46a, which may be coupled to an outer portion 46b. According to some embodiments, for illustration purposes, the outer portion is Figure 1 - Removed in 2C, but in Figure 3A-3C. In some embodiments, the body 42 may include a distal end 48, a proximal end 50, and an inner cavity 52 extending through the distal end 48 and the proximal end 50. In some embodiments, the proximal end 50 of the body 42 may include a connector 54. In some embodiments, the connector 54 may include a male or female Luer connector having a Luer-slip or Luer-lock feature configured to connect the connector 54 to a medical device, such as the medical device 102 shown in Figures 4-7 or other suitable medical devices.

[0029] In some embodiments, connector 54 may include any suitable needleless connector. An exemplary needleless connector may be described in U.S. Pat. No. 8,066,670, filed on Nov. 5, 2007, entitled “VASCULAR ACCESS DEVICE SEPTUM VENTING,” which is incorporated herein by reference. In some embodiments, the needleless connector may include a SMARTSITE 1000 connector provided by Becton Dickinson, Inc. TM Needleless connector.

[0030] In some embodiments, the connector 54 may include a body 55, a septum 56 disposed within the body 55, and an internal blunt cannula 58. In some embodiments, the septum 56 may include a split septum. In some embodiments, the internal blunt cannula 58 may provide an internal fluid path 60 in fluid communication with the lumen 52 of the body 42. In some embodiments, an access luer connector of a medical device (e.g., an infusion device) may contact the proximal end 62 of the septum 56 and compress the septum 56, thereby opening the internal fluid path 60. In some embodiments, when the access luer connector is removed, the septum 56 may return to cover the internal blunt cannula 58 and once again close the internal fluid path 60. In some embodiments, the proximal end 62 may include a generally flat proximal surface 64, which may facilitate wiping or scrubbing of the proximal end 62. In some embodiments, the septum 56 may include a slit 65.

[0031] In some embodiments, at least a portion of the connector 54 and the proximal end 50 can be integrally formed as a single unit. In some embodiments, the connector 54 can be coupled to the proximal end 50 via a Luer connector, which can include a Luer slide lock feature, a Luer twist lock feature (e.g., Figure 3A as shown), or other suitable connections.

[0032] In some embodiments, the distal end 48 of the body 42 may include a Luer connector 66 or another suitable connector that can be coupled to the catheter assembly 16. In some embodiments, the Luer connector 66 can include a slide-lock or twist-lock male Luer connector. In some embodiments, the distal end 48 of the body 42 can be coupled to an adapter 38, which can include a female Luer adapter.

[0033] In some embodiments, housing 46 may be movable relative to connector 54. In some embodiments, connector 54 may be disposed within housing 46 when housing 46 is disposed in the proximal position. In some embodiments, connector 54 may be disposed proximal to housing 46 in response to housing 46 moving from the proximal position to the distal position. In some embodiments, device 40 may not include spring 44, and housing 46 may be manually returned to the proximal position and / or moved to the distal position.

[0034] In some embodiments, the inner portion 46a may be coupled 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 formed or monolithically formed as a single unit.

[0035] In some embodiments, housing 46 can be coupled to proximal end 68 of spring 44 and can surround connector 54. In some embodiments, connector 54 can be sealed within housing 46. In some embodiments, distal end 70 of spring 44 can be coupled to body 42. In some embodiments, housing 46 can include tab 71, which can include antimicrobial compound 73. In some embodiments, housing 46 can exclude tab 71.

[0036] As an example, one or more of the following: body 55, fins 71, and shell 46 can be made of a thermoplastic material that can incorporate functional moieties, such as fluorine or silicone, that may tend to migrate to the surface of the thermoplastic material. The functional moieties on the surface of the thermoplastic material may reduce bacterial adhesion by creating a hydrophobic and lubricious environment. As another example, one or more of the following: body 55, shell 46, and fins 71 can include an antimicrobial compound 73 that can be applied as an antimicrobial coating. As yet another example, fins 71 can include a pad or cloth that can include an antimicrobial compound 73.

[0037] In a specific embodiment, the antimicrobial agent used as the antimicrobial compound 73 included in the pad or cloth or antimicrobial coating of the wing 71 may include chlorhexidine, including chlorhexidine diacetate (CHA) and chlorhexidine gluconate (CHG). However, any other antimicrobial agent widely reported in the literature may also be used. Non-limiting examples of antimicrobial coatings and related application methods are described in: U.S. Pat. No. 8,691,887, filed on June 2, 2009, entitled “ANTIMICROBIAL COATING COMPOSITIONS”; U.S. Pat. No. 8,754,020, filed on April 22, 2013, entitled “ANTIMICROBIAL LUBRICANT COMPOSITIONS”; U.S. Pat. No. 4,713,402, filed on August 30, 1985, entitled “PROCESS FOR PREPARING ANTITHROMBOGENIC / ANTIBIOTIC POLYMERIC PLASTIC MATERIALS”; U.S. Pat. No. 4,442,133, filed on February 22, 1982, entitled “ANTIBIOTIC BONDING OF VASCULAR PROSTHESES AND OTHER IMPLANTS”; U.S. Pat. No. 4,713,402, filed on August 30, 1985, entitled “PROCESS FOR PREPARING ANTITHROMBOGENIC / ANTIBIOTIC POLYMERIC PLASTIC MATERIALS”; U.S. Pat. No. 4,442,133, filed on February 22, 1982, entitled “ANTIBIOTIC BONDING OF VASCULAR PROSTHESES AND OTHER IMPLANTS”; U.S. Pat. No. 4,713,402, filed on August 30, 1985, entitled “ No. 4,678,660, filed on March 21, 1990, entitled “ANTI-INFECTIVE AND ANTITHROMBOGENIC MEDICAL ARTICLES AND METHOD FOR THEIR PREPARATION”; No. 6,261,271, filed on January 13, 1998, entitled “ANTI-INFECTIVE AND ANTITHROMBOGENIC MEDICAL ARTICLES AND METHOD FOR THEIR PREPARATION”; and No. 5,322,659, filed on September 21, 1990, entitled “METHOD FOR RENDERING A SUBSTRATE SURFACE ANTITHROMBOGENIC AND / OR ANTI-INFECTIVE,” each of which is incorporated herein by reference.

[0038] In some embodiments, when the housing 46 is disposed in a proximal position, for example Figure 2A and 3AAs shown, the flap 71 can cover the connector 54, the antimicrobial compound 73 can contact the connector 54, and the spring 44 can be uncompressed. In some embodiments, the flap 71 can be responsive to the flap 71 being moved from a closed position (e.g. Figure 2A ) to an open position (e.g. Figure 2B or Figure 2C ) and automatically wipe connector 54. In some embodiments, antimicrobial compound 73 can be transferred from fin 71 to septum 56 in response to fin 71 contacting and / or wiping septum 56.

[0039] In some embodiments, in response to the housing 46 moving from the proximal position to the distal position, the spring 44 can be compressed and the flap 71 can open. In some embodiments, the distal position can include, for example Figure 2B and 3B The first distal position shown in or for example Figure 2C and 3C The second distal position shown in .

[0040] In some embodiments, the device 40 may include a support structure 72, which may include one or more elongated guides 74. In some embodiments, the housing 46 may include one or more flanges 76. In some embodiments, the flanges 76 may be configured to move along the elongated guides 74 in a distal direction in response to the housing 46 moving from a proximal position to a distal position.

[0041] In some embodiments, the elongated guide 74 can include one or more stops 78. In some embodiments, the flange 76 can be configured to move in the distal direction along the elongated guide 74 when the flange 76 is proximal to the stop 78 and spaced apart from the stop 78. In some embodiments, in response to the movement of the housing 46 in the distal direction and the flange 76 contacting the stop 78, for example, Figure 2B As shown, the housing 46 and the support structure 72 can be configured to move together in the distal direction. For example, in response to the housing 46 moving in the distal direction and the flange 76 contacting the stop 78, the housing 46 and the support structure 72 can be configured to move together in the distal direction. Figure 2B 2C. In some embodiments, flange 76 can facilitate holding or gripping of housing 46 by a clinician.

[0042] In some embodiments, the proximal end 80 of the support structure 72 can include an opening 82. In some embodiments, the diameter of the opening 82 can be smaller than the diameter of the flap 71, which can prevent the flap 71 from opening and / or fully opening when the housing 46 is disposed in the proximal position.

[0043] In some embodiments, Figure 2C and 3CAs shown, connector 54 can be exposed for connection to a passage Luer connector of a medical device. In some embodiments, threads 84 can be exposed, such as Figure 2C and 3C In response to the connection of the access luer connector of the medical device to the connector 54, the wing 71 can be maintained in the fully open position, for example, as shown. Figure 2C and 3C In some embodiments, in response to the clinician releasing his or her hold on the housing 46 and / or the support structure 72, the spring 44 can return the housing 46 and / or the support structure 72 to the proximal position.

[0044] Reference now Figure 4A -4E, in some embodiments, the housing 86 for sterilizing the 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 Figure 2A -3C discussed connector 54. In some embodiments, the proximal end 94 may include an access opening 98 configured to receive a medical device 102 (eg, an infusion set or a syringe). In some embodiments, the housing 86 may be connected to Figure 1 The catheter system 14 or any other suitable catheter system may be used together.

[0045] In some embodiments, the housing 86 may include a cover 100 coupled to the proximal end 94 of the body 90 and covering the access opening 98. In some embodiments, the cover 100 may include an antimicrobial compound 73. In some embodiments, the cover 100 may be configured to automatically close in response to the removal of the medical device 102 from the access opening 98, and the antimicrobial compound 73 may be configured to contact the proximal end of the connector 88. In some embodiments, the cover 100 may be spring loaded, which may help close the cover 100 in response to the 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, when the cover 100 is closed, the connector 88 may be enclosed or sealed within the housing 86.

[0046] In some embodiments, the cover 100 may be responsive to the cover 100 being moved from, for example, Figure 4B The closed position shown is moved to e.g. Figure 4CIn some embodiments, the cover 100 can wipe the connector 88 in response to the cover 100 being moved from the open position to the closed position. In some embodiments, the medical device 102 can be connected to the connector 88 when the cover 100 is in the open position. In some embodiments, the automatic closing of the cover 100 and the wiping of the connector 88 in response to the removal of the medical device 102 from the access opening 98 can protect the connector 88 from bacterial contamination.

[0047] In some embodiments, the cover 100 can be coupled to the proximal end 94 at a pivot 104. In some embodiments, the cover 100 can be configured to pivot about the pivot 104 between an open position and a closed position. In some embodiments, the cover 100 can be configured to pivot about the pivot 104 on an axis generally parallel to a central axis 106 of the body 90. In some embodiments, the pivot 104 can include a pin or other suitable pivot mechanism. In some embodiments, in response to the opening of the cover 100, a new cleaning pad can be exposed and an old cleaning pad can be removed.

[0048] Reference now Figure 5A -5E, in some embodiments, a housing 108 for sterilizing a connector 88 may include a body 110, which may include 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 include an access opening 118, which is configured to receive a medical device 102, such as an infusion set or a syringe. In some embodiments, the access opening 118 may be spaced apart from the proximal end 119 of the connector 88 so that the medical device 102 and the connector 88 can be directly coupled together. In some embodiments, the housing 108 may include or correspond to Figure 4A - Housing 86 described in -4E.

[0049] In some embodiments, housing 108 may include a cover 120 coupled to body 110 and covering access opening 118. In some embodiments, cover 120 may include antimicrobial compound 73. In some embodiments, cover 120 may be configured to automatically close in response to removal of medical device 102 from access opening 118, and antimicrobial compound 73 may be configured to contact proximal end 119 of connector 88. In some embodiments, cover 120 may be spring loaded, which may help close cover 120 in response to removal of medical device 102 from access opening 118. In some embodiments, cover 120 may include a torsion spring. In some embodiments, connector 88 may be enclosed or sealed within housing 108 when cover 120 is closed.

[0050] In some embodiments, the cover 120 may be responsive to the cover 120 being moved from, for example, Figure 5B The closed position shown is moved to e.g. Figure 5C In some embodiments, the cover 120 can wipe the connector 88 in response to the cover 120 moving from the open position to the closed position. In some embodiments, the medical device 102 can be coupled to the connector 88 when the cover 120 is in the open position. In some embodiments, the automatic closing of the cover 120 and the wiping of the connector 88 in response to the removal of the medical device 102 from the access opening 118 can protect the connector 88 from bacterial contamination.

[0051] In some embodiments, the cover 120 can be coupled to the body 110 at one or more pivots 122. In some embodiments, the cover 120 can be configured to pivot about the pivots 122 between an open position and a closed position. In some embodiments, the cover 120 can be configured to pivot about the pivots 122 between an open position and a closed position on an axis that is substantially perpendicular to a central axis 124 of the body 110. In some embodiments, the pivots 122 can each include a pin or other suitable pivot mechanism.

[0052] In some embodiments, a first distal arm 128a and a second distal arm 128b (which may be collectively referred to as "distal arms 128" in the present disclosure) may extend from a first pivot 122a and a second pivot 122b (which may be collectively referred to as "pivot 122" in the present disclosure), respectively. In some embodiments, a first proximal arm 130a and a second proximal arm 130b (which may be collectively referred to as "proximal arms 130" in the present disclosure) may be coupled to a cover 120, which may be configured to contact the proximal end of the connector 88 when the cover 120 is in a closed position. In some embodiments, a semicircular portion 132 may be disposed between the distal arm 128 and the proximal arm 130. In some embodiments, the semicircular portion 132 may be configured to be mounted around the body 110 when the cover is in an open position, such that the semicircular portion and the body 110 contact each other and are not spaced apart.

[0053] Reference now Fig. 6A-6D, in some embodiments, a housing 134 for sterilizing the 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, which is configured to receive a medical device 102, such as an infusion set or a syringe. In some embodiments, the access opening 144 may be spaced apart from the proximal end 119 of the connector 88 so that the medical device 102 and the connector 88 can be directly coupled together. In some embodiments, the housing 134 may include or correspond to Figure 4A -4E described housing 86 and / or Figure 5A - Housing 108 described in -5E.

[0054] In some embodiments, housing 134 can include a cover 120 coupled to body 136 and covering access opening 144. In some embodiments, cover 120 can include antimicrobial compound 73. In some embodiments, cover 120 can be configured to automatically close in response to removal of medical device 102 from access opening 144, and antimicrobial compound 73 can be configured to contact proximal end 119 of connector 88. In some embodiments, an antimicrobial strip (e.g., Fig. 7A -7D) can be disposed over access opening 144. In some embodiments, cover 120 can be spring loaded, which can facilitate closing of cover 120 in response to removal of medical device 102 from access opening 144. In some embodiments, connector 88 can be enclosed or sealed within housing 134 when cover 120 is closed.

[0055] In some embodiments, the cover 120 may be responsive to the cover 120 being moved from, for example, Figure 6B The closed position shown is moved to e.g. Figure 6C In some embodiments, the cover 120 can wipe the connector 88 in response to the cover 120 moving from the open position to the closed position. In some embodiments, the medical device 102 can be coupled to the connector 88 when the cover 120 is in the open position. In some embodiments, the automatic closing of the cover 120 and the wiping of the connector 88 in response to the removal of the medical device 102 from the access opening 144 can protect the connector 88 from bacterial contamination.

[0056] In some embodiments, the cover 120 can be coupled to the body 136 at one or more pivots 148. In some embodiments, the cover 120 can be configured to pivot about the pivots 148 between an open position and a closed position. In some embodiments, the cover 120 can be configured to pivot about the pivots 148 between an open position and a closed position on an axis that is substantially perpendicular to a central axis 149 of the body 136. In some embodiments, the pivots 148 can each include a pin or another suitable pivot mechanism.

[0057] In some embodiments, the cover 120 may include a distal tab 150 and an L-shaped portion 152 coupled 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 depression of the distal tab 150, the L-shaped portion 152 may rise and the access opening 144 may be exposed.

[0058] Reference now Fig. 7A -7D, in some embodiments, the housing 154 for sterilizing the connector 88 may include a body 156, which may include a distal end 158, a proximal end 160, and an inner cavity 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: Figure 4A - Shell 86 described in 4E, about Figure 5A -5E describes the housing 108, and Fig. 6A - Housing 134 described in -6D.

[0059] In some embodiments, body 156 can include a distal piece 166 and a proximal piece 168 that can rotate relative to distal piece 166. In some embodiments, antimicrobial strip 170 can be disposed over access opening 164. In some embodiments, antimicrobial strip 170 can be advanced and across access opening 164 in a conveyor-like manner in response to rotation of proximal piece 168 relative to distal piece 166. In some embodiments, proximal piece 168 can be rotated relative to distal piece 166 in a first direction to automatically pull antimicrobial strip 170 across proximal end 119 of connector 88 prior to use of connector 88. In some embodiments, aperture 172 in antimicrobial strip 170 can allow medical device 102 to access and couple to connector 88.

[0060] In some embodiments, after medical device 102 is disconnected from connector 88 and removed from body 156, proximal member 168 can be rotated in a first direction to pull antimicrobial strip 170 across proximal end 119 and wipe proximal end 119 of connector 88. In some embodiments, antimicrobial strip 170 can include antimicrobial compound 73. In some embodiments, a color change of antimicrobial strip 170 can indicate that antimicrobial strip 170 is used up and housing 154 can be replaced.

[0061] In some embodiments, rotating distal member 166 and / or proximal member 168 can rotate a set of gears that translate the rotational motion into movement of antimicrobial strip 170 across aperture 172, thereby allowing exposure of a fresh portion of antimicrobial strip 170. In some embodiments, the set of gears can be part of a differential mechanism, which can include a crown wheel, pinion gear, sun gear, planetary gear, differential shaft, etc., as understood in the art. In some embodiments, antimicrobial strip 170 can move across aperture 172 in response to distal member 166 and / or proximal member 168 rotating in a first direction.

[0062] Reference now Fig. 8A -8G, in some embodiments, the apparatus 174 for sterilizing the connector 88 may include an inner shell 176 (which may be annular) and an outer shell 178 (which may be annular). In some embodiments, the inner shell 176 may include a proximal opening 179 and may be configured to receive the connector 88. In some embodiments, the connector 88 may be configured to snap fit with the inner shell 176. In some embodiments, the outer shell 178 may be positioned relative to the inner shell 176 in a proximal position (e.g., Fig. 8A and 8C ) and distal locations (e.g. Figure 8B In some embodiments, the housing 178 may include a set of teeth 180.

[0063] In some embodiments, the device 174 can include a ratchet 182, which can include a set of internal teeth 184 and a set of external teeth 186. In some embodiments, a first spindle 188 can extend through the ratchet 182 and can include a pawl 190. In some embodiments, a second spindle 192 can be disposed on an opposite side of the inner housing 176 from the first spindle 188.

[0064] In some embodiments, antimicrobial strip 194 can be wrapped around second spindle 192 and coupled to first spindle 188. In some embodiments, antimicrobial strip 194 can extend across proximal opening 179 of inner shell 176. In some embodiments, in response to movement of outer shell 178 between the proximal position and the distal position, pawl 190 can be caught on the set of internal teeth 184, a set of teeth 180 on the inner surface can continuously engage the set of external teeth 186, and ratchet 182 and first spindle 188 can be rotated so that antimicrobial strip 194 moves across proximal opening 179 of inner shell 176. In some embodiments, antimicrobial strip 194 can include cloth, tape, or other suitable material. In some embodiments, antimicrobial strip 194 can include antimicrobial compound 73.

[0065] In some embodiments, in response to the movement of housing 178 between the proximal position and the distal position, antimicrobial strip 194 can be wrapped around first mandrel 188 and / or unwound from second mandrel 192. In some embodiments, antimicrobial strip 194 can include a plurality of holes 196 configured to allow medical device 102 to extend through connector 88 and be coupled to connector 88 for infusion or blood draw. In some embodiments, the distal end of connector 88 can be coupled to extension tube 34 or adapter 38.

[0066] In some embodiments, the housing 178 can include a flap 198. In some embodiments, the flap 198 can be opened in response to movement of the housing 178 between the proximal position and the distal position. In some embodiments, the housing 178 can be configured to enclose the connector 88.

[0067] In some embodiments, the device 174 can include another ratchet 200, which can also include a set of internal teeth 184 and a set of external teeth 186. In some embodiments, the first spindle 188 can extend through the other ratchet 200. In some embodiments, the antimicrobial strip 194 can be disposed between the ratchet 182 and the other ratchet 200. In some embodiments, the device 174 can include an arm 202 extending through the first spindle 188. In some embodiments, the first spindle 188 can be configured to rotate relative to the arm 202. In some embodiments, the arm 202 can be coupled to the inner housing 176.

[0068] Reference now Fig.9AAccording to some embodiments, the device 40 is illustrated as being 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 configured to slide axially toward each other to move the device 40 from a retracted position in which the connector 54 is enclosed in the housing 46 to an extended position in which the connector 54 is exposed proximal to the housing. For example, the housing 46 may slide axially in a distal direction from the retracted position, and / or the body 42 may slide axially in a proximal direction from the retracted position. In some embodiments, the housing 46 may slide axially in a distal direction 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, when the device 40 is in the extended position, the housing 46 may be disposed in a distal position.

[0069] In some embodiments, the device 40 may include a spring 210, which may include a proximal end and a distal end. In some embodiments, the proximal end of the spring 210 may be coupled to the body 42. In some embodiments, the distal end of the spring 210 may push a cam body 212 of the device 40 distally. In some embodiments, the inner surface of the outer portion 46b may include one or more tracks 214. In some embodiments, the outer surface of the cam body 212 may include one or more slots 216, which may extend completely or partially through the cam body 212. In some embodiments, when the device 40 is in the retracted position, such as Fig.9A As shown, the track 214 can be disposed within a slot 216 , which can prevent rotation of the cam body 212 .

[0070] Reference now Fig. 9B In some embodiments, when the device 40 moves from the retracted position to the extended position, the body 42 can slide axially in the proximal direction and / or the housing 46 can slide axially in the distal direction. In these embodiments, the track 214 can slide within the slot 216. In some embodiments, when the housing 46 slides axially in the distal direction, the flange 76 can move along the elongated guide 74, or the flange 76 and the support structure 72 can move together in the distal direction.

[0071] Reference now Fig. 9C-9E, according to some embodiments, the device 40 is shown in an extended position. In some embodiments, in response to the housing 46 and the body 42 sliding axially toward each other, the track 214 can be removed from the slot 216, which can allow the cam body 212 to rotate. In some embodiments, one or more inclined surfaces of the cam body 212 and / or one or more teeth 218 coupled to the body 42 can cause the cam body 212, which can be urged distally by the spring 210, to rotate. In some embodiments, the cam body 212 can rotate until the track 214 contacts the stop surface 220 of the cam body 212, for example, as shown in FIG. Fig. 9C shown.

[0072] In some embodiments, the device 40 can be locked in the extended position. In some embodiments, when the device 40 is in the extended position, the track 214 and / or the teeth 218 can contact the cam body 212, which can lock the device 40 in the extended position. In some embodiments, in response to the body 42 moving proximally beyond the extended position, the device 40 can be configured to unlock and return to the retracted position. For example, the track 214 can no longer contact the stop surface 220, and the cam body 212 can be rotated so that the track 214 can slide through the slot 216.

[0073] Reference now Fig.9F In some embodiments, flap 71 can cover connector 54 and / or antimicrobial compound 73 can contact connector 54 when device 40 is in the retracted position. In some embodiments, flap 71 can be responsive to flap 71 being moved from a closed position (e.g., Fig.9F ) to the open position (e.g. Fig. 9C -9E) automatically wipes connector 54. In some embodiments, antimicrobial compound 73 can be transferred from flap 71 to septum 56 in response to flap 71 contacting and / or wiping septum 56.

[0074] Reference now Fig. 10A 10G, according to some embodiments, the position sequence of the device 40 is shown in the order from 10A to 10G. Fig. 10A As shown, in some embodiments, in response to the housing 46 and the body 42 sliding axially toward each other to the first position, the track 214 can be partially removed from the slot 216.

[0075] like Fig. 10B As shown, in some embodiments, in response to the housing 46 and the body 42 sliding axially toward each other to the second position, the track 214 can be removed from the slot 216, which can allow the cam body 212 to rotate. In some embodiments, the inclined surface 222 of the cam body 212 and / or one or more teeth 218 coupled to the body 42 can cause the cam body 212 to rotate, which can be urged distally by the spring 210.

[0076] like Fig. 10C As shown, in some embodiments, the cam body 212 can be rotated until the track 214 contacts the stop surface 220 of the cam body 212. In some embodiments, the track 214 and / or the teeth 218 can contact the cam body 212 when the device 40 is in the extended position, which can lock the device 40 in the extended position.

[0077] like Fig. 10D As shown in FIG. 10E , in some embodiments, in response to the body 42 moving proximally beyond the extended position, or the connector 54 moving further away from the housing 46 than in the extended position, the device 40 can be configured to unlock and return to the retracted position. For example, the track 214 can no longer contact the stop surface 220, and the cam body 212 can be rotated so that the track 214 can slide through the slot 216, for example, as shown in FIG. Fig.10F - As shown in 10G.

[0078] Figures 9-10 show example mechanisms for moving the device 40 from a retracted position to an extended position and back to a retracted position according to some embodiments. It should be understood that variations of this mechanism or other mechanisms may be used. All examples and conditional language cited herein are intended for teaching purposes to help the reader understand the present invention and the concepts contributed by the inventors to further develop the art, and should be interpreted as not being limited to these specifically cited examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and modifications may be made thereto without departing from the spirit and scope of the invention.

Claims

1. A coupling device for coupling a vascular access device to a medical device, the coupling device include: case; and a body partially disposed within the housing, wherein the body includes a distal end, a proximal end, and a lumen extending through the distal end and the proximal end, wherein the proximal end includes a connector, Wherein, the housing and the body are configured to slide axially toward each other to move the coupling device from a retracted position in which the connector is enclosed within the housing to an extended position in which the connector is exposed proximally of the housing.

2. The coupling device according to claim 1, in, The housing includes a flap, wherein the flap covers the connector when the coupling device is in the retracted position, wherein the flap opens in response to the housing moving distally from the retracted position.

3. The coupling device according to claim 1, further comprising a spring, in, The spring includes a distal end and a proximal end, wherein the distal end of the spring is coupled to the body, and wherein the proximal end of the spring urges the housing proximally.

4. The coupling device according to claim 2, in, The flap includes an antimicrobial compound, wherein the antimicrobial compound contacts the connector when the device is in the retracted position.

5. The coupling device according to claim 1, in, The distal end of the body includes a Luer connector.

6. The coupling device of claim 1 further comprising a support structure comprising an elongated guide member, in, The housing includes a flange, wherein the flange is configured to move in a distal direction along the elongated guide in response to distal movement of the housing from the retracted position.

7. The coupling device according to claim 6, in, The elongated guide includes a stop, wherein the flange is configured to move in the distal direction along the elongated guide when the flange is proximal to and spaced apart from the stop, wherein in response to the shell moving from the retracted position in the distal direction and the flange contacting the stop, the shell and the support structure are configured to move together in the distal direction.

8. The coupling device according to claim 1, in, The coupling device is configured to lock in the extended position.

9. The coupling device according to claim 8, in, In response to the body moving proximally beyond the extended position, the coupling device is configured to unlock and return to the retracted position.

10. A housing for sterilizing a vascular access device connector, the housing include: a body comprising a distal end, a proximal end, and a lumen extending through the distal end and the proximal end, wherein the distal end is configured to receive a vascular access device connector, wherein the proximal end includes an access opening configured to receive an infusion device; and A cover is coupled to the body and covers the access opening, wherein the cover includes an antimicrobial compound, wherein, in response to removal of the infusion set from the access opening, the cover is configured to automatically close and the antimicrobial compound is configured to automatically contact and scrub the proximal end of the vascular access device connector.

11. The housing according to claim 10, in, The cover is spring loaded.

12. The housing according to claim 10, in, The cover is coupled to the body at a pivot, wherein the cover is configured to pivot about the pivot between an open position and a closed position, wherein the cover is configured to pivot about the pivot on an axis generally perpendicular to a central axis of the body.

13. The housing according to claim 10, in, The cover is coupled to the body at a pivot, wherein the cover is configured to pivot about the pivot between an open position and a closed position, wherein the cover is configured to pivot about the pivot on an axis generally parallel to a central axis of the body.

14. The housing according to claim 13, in, The movable portion of the body includes a distal end, wherein The distal end of the movable portion includes a first arm extending from the pivot and a second arm extending from another pivot aligned with the pivot.

15. The housing according to claim 14, in, The movable portion of the body includes a proximal end and a semicircular portion disposed between a distal end of the movable portion and the proximal end of the movable portion, wherein the distal end of the movable portion includes the first arm and the second arm, wherein the proximal end of the movable portion includes a contact portion configured to contact the proximal end of the vascular access device connector when the cover is in the closed position, wherein the semicircular portion is configured to fit around the body when the cover is in the open position.

16. The housing according to claim 13, in, The cover includes a distal tab and an L-shaped portion coupled to the distal tab, wherein in response to depression of the distal tab, the L-shaped portion rises and the access opening is exposed.

17. A disinfection device for disinfecting a vascular access device connector, the disinfection device include: an inner housing including a proximal opening and configured to receive a vascular access device connector; an outer shell movable between a proximal position and a distal position relative to the inner shell, wherein the outer shell includes a set of teeth; a ratchet comprising a set of internal teeth and a set of external teeth; and a first spindle extending through the ratchet wheel and including a pawl; a second mandrel disposed on a side of the inner shell opposite to the first mandrel; an antimicrobial strip wrapped around the second mandrel and coupled to the first mandrel, wherein the antimicrobial strip extends over the proximal opening of the inner shell; Wherein, in response to the movement of the outer shell between the proximal position and the distal position, the pawl is clamped on the set of internal teeth, the set of teeth on the inner surface successively engages the set of external teeth, and the ratchet and the spindle rotate, so that the antimicrobial strip moves across the proximal opening of the inner shell.

18. The disinfection device according to claim 17, in, The antimicrobial strip is wrapped around the first mandrel and unwound from the second mandrel in response to movement of the housing between the proximal position and the distal position.

19. The disinfection device according to claim 17, further comprising another ratchet, in, The first spindle extends through the other ratchet, wherein the antimicrobial strip is disposed between the ratchet and the other ratchet.

20. The sterilizing device of claim 17, further comprising an arm extending through the spindle, in, The spindle is configured to rotate relative to the arm, wherein the arm is coupled to the inner housing.

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