Sterilizing device for female connector

Abstract

The invention relates to a sterilizing device for sterilizing a medical female connector. The sanitizing device includes an inner housing receiving the connector, the inner housing having an absorbent material containing a sanitizing or antibacterial agent. The disinfection device also includes an outer housing receiving the inner housing, the outer housing having an outer wall, where the inner housing is rotatable within the outer housing. An indicator is located between the outer wall and a transparent collar comprising at least one rib. The indicators include a first visual indicator and a second visual indicator hidden by the first visual indicator. The inner housing includes a boss element that extends through the outer wall and the indicator and is attached to the collar. Rotation of the collar causes rotation of the absorbent material and causes the rib to remove sufficient portions of the indicator to expose the second visual indicator to provide a visual indication that the connector is disinfected.

Description

Technical Field

[0001] The present disclosure generally relates to an apparatus for disinfecting and sterilizing a medical female connector, and more particularly, to a disinfection apparatus that includes an indicator element and a transparent collar having at least one rib, wherein rotation of the collar causes the at least one rib to remove a sufficient portion of the indicator element to expose a visual indicator, thereby providing a visual indication that the female connector has been disinfected. Background Art

[0002] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. VADs are generally divided into two categories: peripheral catheters and central venous catheters. When delivering fluids or medications, bacteria and other microorganisms can enter a patient's vascular system from access ports, ports, or valves when connected to a VAD. Each access port, port, valve, or connection is associated with a certain risk of transmitting catheter-related bloodstream infections (CRBSIs), which are costly to treat and can be life-threatening.

[0003] To reduce the number of CRBSI cases and ensure the proper use and maintenance of VADs, practice standards that include disinfection and cleaning procedures have been established. Disinfection caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines and are also incorporated into the Infusion Nurses Society (INS) guidelines.

[0004] In developed markets, when using an IV catheter, a needleless connector is typically used to close the system, and then the needleless connector is used to administer medications or other necessary fluids to the patient via the catheter. The INS practice standards recommend the use of needleless connectors and state that "prior to each use, it should be disinfected using ethanol, iodine, or a chlorhexidine gluconate / ethanol mixture in a consistent and thorough manner." The disinfection of needleless connectors ultimately aims to help reduce bacteria that may survive on the surface and may cause various catheter-related complications, including CRBSIs. Nurses typically use 70% isopropyl alcohol (IPA) pads to perform this disinfection task by performing the known "wipe the interface." However, compliance with this practice is typically low. In addition to the lack of compliance with "wipe the interface," it has also been noted through interviews with clinicians that the wipe time, dry time, and the number of times the needleless connector is wiped typically vary.

[0005] Throughout the course of procedures associated with the transmission of microorganisms that can cause CRBSI, there are numerous risks of contact or contamination. Contamination can occur during drug mixing, cannula attachment, and insertion into the access interface. Because the process of connecting to a VAD is very common and simple, the risks associated with accessing the patient's vascular system are often overlooked. Currently, the risks to the hospital and the patient are primarily a function of the efforts of the clinician performing the connection, and this effort is largely uncontrollable. In particular, it has been found that healthcare providers do not fully understand the implications of not following the wiping protocol. As a result, healthcare providers may not disinfect the interface within the recommended time.

[0006] Accordingly, there is a need for a disinfecting cap that can disinfect a needleless connector while also enhancing compliance with the clinical practice of "wiping the interface" prior to accessing the line. SUMMARY OF THE INVENTION

[0007] One aspect of the present disclosure relates to a disinfecting device for disinfecting a medical female connector. According to an exemplary embodiment of the present disclosure, the disinfecting device generally includes an absorbent material having a disinfectant or antibacterial agent, an inner housing, an outer housing, an indicator element, a transparent collar, and a boss element. The inner housing includes an inner wall and a first open end that receives the absorbent material, wherein the female connector is inserted into the first open end and contacts the absorbent material. The outer housing includes an outer wall and a second open end that receives the inner housing, wherein the inner housing and the absorbent material are rotatable within the outer housing. The indicator element is located between the outer wall and the transparent collar, wherein the indicator element includes a first visual indicator and a second visual indicator hidden by the first visual indicator. Additionally, the collar includes at least one rib element that contacts the indicator element. The boss element extends from the inner wall and extends through the outer wall and the indicator element, and is attached to the collar. Rotation of the collar causes a corresponding rotation of the absorbent material to disinfect the female connector. Rotation of the collar also causes the at least one rib element to remove a sufficient portion of the indicator element to expose the second visual indicator, thereby providing a visual indication that the female connector has been disinfected.

[0008] In one or more embodiments, the medical female connector is selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, or a hemodialysis connector.

[0009] In one embodiment, the medical female connector is a needleless connector having a passage surface, a septum, an interface surface, and interface threads.

[0010] In one or more embodiments, the indicator element is a scratch card having a removable scratch surface.

[0011] In one embodiment, the indicator element comprises an indicator surface made using a removable foil layer.

[0012] In one or more embodiments, the first visual indicator is a first color and the second visual indicator is a second color.

[0013] The outer housing may further comprise a plurality of flanges extending from the outer housing to facilitate user handling of the outer housing.

[0014] In one embodiment, the collar comprises a plurality of raised gripping members to facilitate user gripping of the collar.

[0015] In another exemplary embodiment of the present disclosure, the disinfection device generally includes an absorbent material having a disinfectant or antibacterial agent, an inner housing and an outer housing, an indicator element, a transparent collar, a boss element, and a ring member attached to the outer housing and coupled to the collar. The inner housing comprises an inner wall and a first open end for receiving the absorbent material, wherein the female connector is inserted into the first open end and contacts the absorbent material. The outer housing comprises an outer wall and a second open end for receiving the inner housing, wherein the inner housing and the absorbent material are rotatable within the outer housing. The outer housing further comprises a plurality of flanges extending from the outer housing to facilitate user handling of the outer housing. The indicator element is located between the outer wall and the transparent collar, wherein the indicator element comprises a first visual indicator and a second visual indicator hidden by the first visual indicator. Additionally, the collar comprises at least one rib element that contacts the indicator element. The boss element extends from the inner wall and extends through the outer wall and the indicator element and is attached to the collar. Rotation of the collar causes a corresponding rotation of the absorbent material to disinfect the female connector. Rotation of the collar also causes the at least one rib element to remove a sufficient portion of the indicator element to expose the second visual indicator, thereby providing a visual indication that the female connector has been disinfected. The ring member is coupled to the collar by a plurality of frangible elements to form a tamper-resistant structure, wherein the frangible elements are configured to break when the collar is rotated with sufficient torque, and wherein the broken finger-like elements indicate that the collar has been rotated.

[0016] In one embodiment, the second open end forms an annular engagement surface, and the disinfection device further comprises a peelable seal removably attached to the annular engagement surface to prevent the disinfectant or antibacterial agent from leaving the disinfection device.

[0017] In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of: isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, ethanol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0018] In one or more embodiments, the disinfectant or antimicrobial agent includes at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0019] In one embodiment, the disinfectant or antimicrobial agent is a fluid or a gel.

[0020] In another exemplary embodiment of the present disclosure, a method for disinfecting a medical female connector is disclosed. The method includes providing a rotatable inner housing that includes absorbent material having a disinfectant or antimicrobial agent. The method further includes providing an outer housing that receives the inner housing, wherein the inner housing and the absorbent material are rotatable within the outer housing. The method further includes providing an indicator element having a first visual indicator and a second visual indicator hidden by the first visual indicator. A transparent collar is also provided, wherein the collar includes at least one rib element that contacts the indicator element, and rotation of the collar causes a corresponding rotation of the absorbent material to disinfect the female connector. Rotation of the collar also causes the at least one rib element to remove a sufficient portion of the indicator element to expose the second visual indicator, thereby providing a visual indication that the female connector has been disinfected. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 Is an exploded view of a disinfection device according to the present disclosure.

[0022] Figure 2 Is a cross-sectional view of the assembled disinfection device.

[0023] Figure 3 Is an assembly view of the disinfection device, which is shown aligned with a female connector on a central axis.

[0024] Figure 4 Is a cross-sectional view of the disinfection device and the female connector, wherein the interface portion of the female connector is in an inserted position within the disinfection device.

[0025] Figure 5 Is of the transparent collar alongFigure 1 Enlarged view of the observation line 5-5.

[0026] Figures 6A-6D Depict an exemplary operation of the disinfection device. Detailed Description

[0027] Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of the configurations or process steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0028] Embodiments of the present disclosure relate to a disinfection device for disinfecting a medical female connector, such as a female needleless connector. The disinfection device generally includes an absorbent material having a disinfectant or antimicrobial agent, an inner housing and an outer housing, an indicator element, a transparent collar, and a boss element. The inner housing includes an inner wall and a first open end for receiving the absorbent material, where the female connector is inserted into the first open end and contacts the absorbent material. The outer housing includes an outer wall and a second open end for receiving the inner housing, where the inner housing and the absorbent material are rotatable within the outer housing. The indicator element is located between the outer wall and the transparent collar, where the indicator element includes a first visual indicator and a second visual indicator hidden by the first visual indicator. Additionally, the collar includes at least one rib element that contacts the indicator element. The boss element extends from the inner wall and extends through the outer wall and the indicator element and is attached to the collar. Rotation of the collar causes a corresponding rotation of the absorbent material to disinfect the female connector. Rotation of the collar also causes at least one rib element to remove a sufficient portion of the indicator element to expose the second visual indicator, thereby providing a visual indication that the female connector has been disinfected.

[0029] Regarding the terms used in the present disclosure, the following definitions are provided.

[0030] As used herein, the use of "a", "an", and "the" includes both singular and plural.

[0031] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection caused by the presence of a catheter or IV line.

[0032] As used herein, the term "Luer connector" refers to a connecting collar that is a standard way of attaching syringes, catheters, needles with fittings, IV tubes, etc. to each other. A Luer connector consists of male and female interlocking tubes that are slightly tapered to hold together even better through a simple press / twist fit. Luer connectors can optionally include additional threaded outer edges to make them more secure. The male end of a Luer connector is typically associated with a flush syringe and can interlock and connect to the female end located on a vascular access device (VAD). A Luer connector includes a distal end, a proximal end, an outer wall of irregular shape, and a molded central passage for fluid communication from the chamber of the barrel of a syringe to the fitting of a vascular access device (VAD). The Luer connector also has a distal end passage and a proximal end passage, the distal end passage releasably attaching the Luer connector to the fitting of the VAD, and the proximal end passage releasably attaching the Luer connector to the barrel of the syringe.

[0033] Reference Figure 1 , shows an exploded perspective view of a disinfection device 100 according to the present disclosure, the disinfection device being arranged relative to a central axis 102 of the disinfection device 100. Figure 2 Shows a cross-sectional view of the assembled disinfection device 100. In combination Figure 2 Reference Figure 1 , the disinfection device 100 includes a peelable seal 104, an absorbent material 108, an inner housing 110 having a generally cylindrical shape and an outer housing 112, a fixed indicator element 114, and a rotatable collar element 116 having a generally cylindrical shape located at a second end 118 of the disinfection device 100.

[0034] The inner housing 110 includes a first cavity 120 defined by a first inner wall 122 having a first diameter. The first cavity 120 extends through the first end of the inner housing 110 to form a first open end 124. As described below, the first open end 124 provides access to the absorbent material 108. The inner housing 110 further includes an inner wall 126 located at a second end 128 opposite the first open end 124, the inner wall closing the first cavity 120.

[0035] The absorbent material 108 includes a disinfectant or antibacterial agent 130 for disinfecting the female connector. In one or more embodiments, the absorbent material 108 can be a non-woven material, a foam, or a sponge having a porous structure. In a particular embodiment, the foam is a polyurethane foam. In a particular embodiment, the absorbent material 108 is a sponge.

[0036] The absorbent material 108 retains the disinfectant or antimicrobial agent 130 in its porous structure due to surface tension and releases the disinfectant or antimicrobial agent 130 when squeezed or compressed by the inserted female connector. The disinfection device 100 is designed to be compatible with and interact with a variety of disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent 130 may include variants of ethanol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent 130 is selected from the group consisting essentially of: isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, ethanol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In a particular embodiment, the disinfectant or antimicrobial agent 130 includes at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent 130 is a fluid or a gel. In one or more particular embodiments, the disinfectant or antimicrobial agent 130 is 70% isopropyl alcohol (IPA).

[0037] The outer housing 112 includes a second cavity 132 defined by a second inner wall 134 having a second diameter. The second cavity 132 extends through a first end of the outer housing 112 to form a second open end 136 having an annular engagement surface 138. The shape and dimensions of the second cavity 132 are configured to receive the inner housing 110 and to enable the inner housing 110 to rotate within the second cavity 132 about a central axis 102. The outer housing 112 further includes an outer wall 140 having an outer wall opening 142 aligned with the central axis 102. The outer wall 140 is located at a second end 144 opposite the second open end 136 and is used to enclose the second cavity 132. The outer housing 112 also includes a plurality of flange elements 146 extending from the outer housing 112 to facilitate grasping or manipulation of the outer housing 112 by a user, such as a clinician, nurse, or other healthcare provider.

[0038] The seal 104 is removably attached to the engagement surface 138 to seal the disinfection device 100. The seal 104 minimizes the entry of potential particulate hazards and also provides a substantially impermeable outer shell for the disinfection device 100, providing leak protection and a protective outer shell, protecting the contents of the absorbent material 130 housed within the first cavity 120, and / or maintaining a sealed, sterile environment. The seal 104 provides sufficient sealing over a range of temperature, pressure, and humidity levels. In one or more embodiments, the seal 104 includes an aluminum or multi-layer polymer film peel top. In a particular embodiment, the seal 104 is heat sealed or induction sealed to the engagement surface 138.

[0039] The indicator element 114 is generally annular and includes an indicator element opening 148 that is aligned with the outer wall opening 142. The indicator element 114 is located between the outer wall 140 of the outer housing 112 and the collar 116 and may be attached to the outer wall 140 or formed integrally or monolithically with the outer housing 112 to form a single-piece structure. The collar 116 is generally transparent to enable a user to observe the indicator element 114. The collar 116 also includes a plurality of raised gripping members 150 on the outer surface of the collar 116 to facilitate a user's gripping of the collar 116. In one or more embodiments, the collar 116 may include additional features, such as a textured surface, which also enhances the gripping of the collar 116. The collar 116 further includes a collar wall 154 that defines a collar opening 156 that is aligned with the indicator element opening 148 and the outer wall opening 142 along the central axis 102.

[0040] The inner wall 126 of the inner housing 110 further includes an extended boss element 152 that extends through the outer wall 142, the indicator element opening 148, and the collar opening 156 and is attached or bonded to the collar wall 154 using an adhesive or other attachment method. In one or more embodiments, the boss element 152 may be attached to other portions of the collar 116. According to one aspect of the present disclosure, rotation of the collar 116 causes a corresponding rotation of the inner housing 110 within the outer housing 112 about the central axis 102. Rotation of the inner housing 110 also causes the absorbent material 108 to rotate, which in turn disinfects the female connector, as will be described. During rotation of the inner housing 110, the outer housing 112 is stationary.

[0041] Reference Figure 3 , an assembled view of the disinfection device 100 is shown, which is aligned with the female connector 155 on the central axis 102. In one or more embodiments, the female connector 155 may be a needleless connector, a catheter luer connector, a stopcock, or a hemodialysis connector. For illustrative purposes, the present disclosure will now be described in connection with the needleless connector 158. The needleless connector 158 includes an interface portion 160 that has a generally cylindrical outer interface surface 162 that is oriented generally parallel to the central axis 102. The interface portion 160 further includes a passage surface 164 that includes a septum 166. The passage surface 164 and the septum 166 are oriented generally transverse to the interface surface 162. The interface surface 162 further includes an interface thread 168 for threadedly engaging the needleless connector 158 with a known male connector of a syringe or other medical device or instrument.

[0042] According to one aspect of the present disclosure, the interface portion 160 of the needleless connector 158 is first inserted into the disinfection device 100 through the first open end 124 (see arrow 165) until the interface portion 160 contacts the absorbent material 108. Figure 4 A cross-sectional view depicting the disinfection device 100 and the connector 158, where the interface portion 160 is in the inserted position. In this inserted position, the interface portion 160 is inserted into the absorbent material 108 such that the absorbent material 108 contacts the access surface 164, the septum 166, and the side of the interface portion 160 that includes the interface surface 162 and the interface thread 168. This compresses the absorbent material 108 and releases the disinfectant or antimicrobial agent 130 from the absorbent material 108 such that the disinfectant or antimicrobial agent 130 contacts the access surface 164, the septum 166, the interface surface 162, and the interface thread 168 to provide passive disinfection of the access surface 164, the septum 166, the interface surface 162, and the interface thread 168.

[0043] As previously described, rotation of the collar 116 causes a corresponding rotation of the inner housing 110 and thus causes rotation of the absorbent material 108. According to one aspect of the present disclosure, when the interface portion 160 is in the inserted position, the user rotates the collar 116. Rotation of the collar 116 frictionally engages the absorbent material 108 with the interface portion 160 to provide a wiping action on the access surface 164, the septum 166, the interface surface 162, and the interface thread 168, which actively disinfects the access surface 164, the septum 166, the interface surface 162, and the interface thread 168. In one or more embodiments, in addition to passive disinfection of the interface portion 160 due to contact between the disinfectant or antimicrobial agent 130 and the access surface 164, the septum 166, the interface surface 162, and the interface thread 168, active disinfection is also performed due to rotation of the collar 116.

[0044] Reference Figure 5 , an enlarged view of the transparent collar 116 along the Figure 1 observation line 5-5 is shown. The collar 116 includes at least one rib 170 that extends or protrudes from the inner surface 172 of the collar 116 and contacts the indicator element 114. In one embodiment, the collar 116 includes a first rib 174, a second rib 176, a third rib 178, and a fourth rib 180 that are equally spaced around the interior 182 of the collar 116.

[0045] The indicator element 114 includes a removable top indicator surface 184 that includes a first visual indicator visible through a transparent collar 116. The indicator surface 184 is made of a known opaque coating material that cannot be seen through but can be scraped off. The indicator surface 184 is formed on a substrate 186 that includes a second visual indicator that is hidden by and thus invisible through the indicator surface 184. According to one aspect of the present disclosure, due to the contact between the first rib 174, the second rib 176, the third rib 178, and the fourth rib 180 and the indicator surface 184, portions of the indicator surface 184 are removed when the collar 116 and thus the first rib 174, the second rib 176, the third rib 178, and the fourth rib 180 are rotated against the indicator surface 184. For example, when the collar 116 is rotated, the first rib 174, the second rib 176, the third rib 178, and the fourth rib 180 can scrape, wipe, or abrade the indicator surface 184. The collar 116 is rotated until a sufficient amount of the indicator surface 184 is removed to fully expose the second visual indicator and make it visible through the transparent collar 116. According to one aspect of the present disclosure, the number of rotations of the collar 116 required to fully expose the second visual indicator corresponds to the amount of wiping action required to disinfect a portion of the female connector 155, such as the passage surface 164, the diaphragm 166, the interface surface 162, and the interface threads 168 of the connector 158. Thus, the disinfection device 100 provides the user with a passive visual indication that the disinfection of the interface portion 160 has been completed.

[0046] The indicator element 114 can be configured as a scratch card having a scratchable indicator surface 184 that is removed when the collar 116 is rotated and the first rib 174, the second rib 176, the third rib 178, and the fourth rib 180 scrape off the scratchable indicator surface 184. In one or more embodiments, the indicator surface 184 can be made of a thin layer of a known opaque removable foil, ink, or other known opaque coating material that cannot be seen through but can be scraped off. Further, the first rib 174, the second rib 176, the third rib 178, and the fourth rib 180 can include abrasive surfaces or raised edges to facilitate the removal of the indicator surface 184. In one embodiment, the substrate 186 can be made of a material having a suitable hardness such that the indicator surface 184 can be removed by the first rib 174, the second rib 176, the third rib 178, and the fourth rib 180.

[0047] Before the ferrule 116 rotates, the first visual indicator of the indicator element 114 is visible through the transparent ferrule 116. As the ferrule 116 rotates, portions of the indicator surface 184 and thus portions of the first visual indicator are removed until only the second visual indicator formed on the substrate 186 is visible. In one or more embodiments, the first visual indicator may be a first color and the second visual indicator may be a second color. The indicator element 114 may be configured such that when the indicator surface 184 is completely removed, the indicator element 114 completely changes color to indicate that the amount of wiping action required to disinfect a portion of the female connector 155, such as the needleless connector 158, has occurred. For example, when viewed through the transparent ferrule 116, the color of the indicator element 114 may change from black to white to indicate that the needleless connector 158 has been disinfected. Thus, the disinfection device 100 provides a passive visual indication of the completion of the disinfection of the interface portion 160 to the user. In one or more embodiments, the indicator element 114 may be configured to display markings, graphics, symbols, charts, and / or text in addition to or instead of a color change to indicate the disinfection of the female connector.

[0048] Return reference Figure 1 , the disinfection device 100 further includes a tamper-proof structure 188 that indicates whether the ferrule 116 has rotated. In particular, the tamper-proof structure 188 includes a ring member 190 that is fixed relative to the outer housing 112. In one or more embodiments, the ring member 190 may be attached to the outer housing 112 by an interference fit, an adhesive, or formed monostructurally or integrally with the outer housing to form a single-piece structure. The tamper-proof structure 188 also includes a plurality of frangible elements 192, such as frangible finger elements or rod elements, that are coupled between the ferrule 116 and the ring member 90. The frangible elements 192 are configured to break when the ferrule 116 is rotated by hand with sufficient torque, thereby separating the ferrule 116 from the ring member 188 to enable the user to rotate the ferrule 116. The tamper-proof structure 188 indicates whether the ferrule 116 has been rotated. In particular, if the frangible elements 192 have broken, the tamper-proof structure 188 will indicate to the user that the disinfection device 100 may have been used for disinfection. The tamper-proof structure 188 also inhibits accidental rotation of the ferrule 116.

[0049] The disinfection device may be made of any of a variety of types of plastic materials, such as polycarbonate, polypropylene, polyethylene, ethylene glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene copolymer, or any other moldable plastic material used in medical devices. In one or more embodiments, the disinfection device includes a polypropylene or polyethylene material.

[0050] Now in connection with Figures 6A-6DDescribe an exemplary operation of the disinfection device 100 for disinfecting a female connector. For purposes of illustration, the operation of the disinfection device 100 will be described in connection with the connector 158, but the disinfection device 100 is also applicable to another type of female connector 155, such as a catheter luer connector, a stopcock, or a hemodialysis connector. Refer to Figure 6A , the seal 104 is removed to provide access to the absorbent material 108 for the connector 158 (see also Figure 1 ), and the disinfection device 100 is generally aligned with the connector 158 on the central axis 102. Refer to Figure 6B , the interface portion 160 of the connector 158 is inserted into the disinfection device 100 through the first open end 124 until the interface portion 160 contacts the absorbent material 108 in the inserted position. In this position, the interface portion 160 is inserted into the absorbent material 108 such that the absorbent material 108 contacts the access surface 164, the diaphragm 166, and the sides of the interface portion 160 including the interface surface 162 and the interface thread 168. This compresses the absorbent material 108 and releases the disinfectant or antimicrobial agent 130 from the absorbent material 108 such that the disinfectant or antimicrobial agent 130 contacts the access surface 164, the diaphragm 166, the interface surface 162, and the interface thread 168 to provide passive disinfection of the access surface 164, the diaphragm 166, the interface surface 162, and the interface thread 168 (see also Figure 4 ).

[0051] Refer to Figure 6C , the user then grasps the connector 158 and the flange element 146 with one hand and begins to rotate the collar 116 about the central axis 102 in a first direction, such as in a clockwise direction (see arrow 196). When this occurs, the frangible element 192 of the tamper-proof structure 188 (see Figure 1 ) breaks to allow the collar 116 to rotate. During the rotation of the collar 116, portions of the indicator surface 184 are removed due to the contact between the collar 116 and thus the first rib 174, the second rib 176, the third rib 178, and the fourth rib 180 against the indicator surface 184 as the collar 116 rotates. The rotation of the collar 16 also frictionally engages the absorbent material 108 with the interface portion 160 to provide a wiping action on the access surface 164, the diaphragm 166, the interface surface 162, and the interface thread 168, which actively disinfects the access surface 164, the diaphragm 166, the interface surface 162, and the interface thread 168.

[0052] Refer to Figure 6D, the collar 116 can then be rotated in the opposite direction, such as counterclockwise (see arrow 198). Rotate the collar 116 until a sufficient amount of the indicator surface 184 is removed to fully expose the second visual indicator and make it visible through the transparent collar 116. According to one aspect of the present disclosure, the number of rotations of the collar 116 required to fully expose the second visual indicator corresponds to the amount of wiping action required to disinfect a portion of the female connector 155, such as the access surface 164, diaphragm 166, interface surface 162, and interface threads 168 of the connector 158.

[0053] For example, when viewed through the transparent collar 116, the color of the indicator element 114 can change from black to white to indicate that the connector 158 has been disinfected. Thus, the disinfection device 100 provides a passive visual indication of the completion of the disinfection of the interface portion 160 to the user. In one or more embodiments, the indicator element 114 can be configured to display marks, graphics, symbols, charts, and / or text in addition to or instead of a color change to indicate the disinfection of the female connector. Thus, the combination of passive disinfection and active disinfection improves the disinfection effect.

[0054] Embodiment

[0055] Embodiment (a): A disinfection device for disinfecting a medical female connector, the disinfection device comprising: an absorbent material having a disinfectant or antibacterial agent; an inner housing having an inner wall and a first open end for receiving the absorbent material, wherein the female connector is inserted into the first open end and contacts the absorbent material; an outer housing having an outer wall and a second open end for receiving the inner housing, wherein the inner housing and the absorbent material are rotatable within the outer housing; an indicator element located between the outer wall and a transparent collar, the transparent collar having at least one rib element contacting the indicator element, wherein the indicator element includes a first visual indicator and a second visual indicator hidden by the first visual indicator; and a boss element extending from the inner wall and passing through the outer wall and the indicator element and attached to the collar, wherein rotation of the collar causes a corresponding rotation of the absorbent material to disinfect the female connector, and wherein rotation of the collar also causes the at least one rib element to remove a sufficient portion of the indicator element to expose the second visual indicator, thereby providing a visual indication that the female connector has been disinfected.

[0056] Embodiment (b): The disinfection device according to embodiment (a), wherein the medical female connector is selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, or a hemodialysis connector.

[0057] Example (c): The disinfection device according to Example (a), wherein the medical female connector is a needleless connector, and the needleless connector has a passage surface, a diaphragm, an interface surface, and an interface thread.

[0058] Example (d): The disinfection device according to Example (a), wherein the indicator element is a scratch card having a removable scratch surface.

[0059] Example (e): The disinfection device according to Example (a), wherein the indicator element includes an indicator surface made using a removable foil layer.

[0060] Example (f): The disinfection device according to Example (a), wherein the first visual indicator is a first color, and the second visual indicator is a second color.

[0061] Example (g): The disinfection device according to Example (a), further comprising a plurality of flanges extending from the outer housing to facilitate a user in handling the outer housing.

[0062] Example (h): The disinfection device according to Example (a), wherein the collar includes a plurality of raised gripping members to facilitate a user in gripping the collar.

[0063] Example (i): A disinfection device for disinfecting a medical female connector, the disinfection device comprising: an absorbent material having a disinfectant or antibacterial agent; an inner housing having an inner wall and a first open end for receiving the absorbent material, wherein the female connector is inserted into the first open end and contacts the absorbent material; an outer housing having an outer wall and a second open end for receiving the inner housing, wherein the inner housing and the absorbent material are rotatable within the outer housing, wherein a plurality of flanges extend from the outer housing to facilitate a user in handling the outer housing; an indicator element located between the outer wall and a transparent collar, the transparent collar having at least one rib element contacting the indicator element, wherein the indicator element comprises a first visual indicator and a second visual indicator hidden by the first visual indicator; a boss element extending from the inner wall and extending through the outer wall and the indicator element and attached to the collar, wherein rotation of the collar causes a corresponding rotation of the absorbent material to disinfect the female connector, wherein rotation of the collar also causes the at least one rib element to remove a sufficient portion of the indicator element to expose the second visual indicator, thereby providing a visual indication that the female connector has been disinfected; and a ring member attached to the outer housing and coupled to the collar by a plurality of frangible elements to form a tamper-proof structure, wherein the frangible elements are configured to break when the collar is rotated with sufficient torque, wherein the broken finger-like elements indicate that the collar has been rotated.

[0064] Example (j): The disinfection device according to example (i), wherein the medical female connector is selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, or a hemodialysis connector.

[0065] Example (k): The disinfection device according to example (i), wherein the medical female connector is a needleless connector having a passage surface, a septum, an interface surface, and an interface thread.

[0066] Example (l): The disinfection device according to example (i), wherein the indicator element is a scratch card having a removable scratch surface.

[0067] Example (m): The disinfection device according to example (i), wherein the indicator element comprises an indicator surface manufactured using a removable foil layer.

[0068] Example (n): The disinfection device according to example (i), wherein the collar comprises a plurality of raised gripping members to facilitate a user in gripping the collar.

[0069] Example (o): The disinfection device according to Example (i), wherein the first visual indicator is a first color and the second visual indicator is a second color.

[0070] Example (p): The disinfection device according to Example (i), wherein the second open end forms an annular engagement surface, and the disinfection device further comprises a peelable seal removably attached to the annular engagement surface to prevent the disinfectant or antimicrobial agent from leaving the disinfection device.

[0071] Example (q): The disinfection device according to Example (i), wherein the disinfectant or antimicrobial agent is selected from the group consisting essentially of: isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tertiary butyl hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, ethanol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0072] Example (r): The disinfection device according to Example (q), wherein the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0073] Example (s): The disinfection device according to Example (r), wherein the disinfectant or antimicrobial agent is a fluid or a gel.

[0074] Example (t): A method for disinfecting a medical female connector, the method comprising: providing a rotatable inner housing comprising absorbent material having a disinfectant or antimicrobial agent; providing an outer housing receiving the inner housing, wherein the inner housing and the absorbent material are rotatable within the outer housing; providing an indicator element having a first visual indicator and a second visual indicator hidden by the first visual indicator; providing a transparent collar having at least one rib element that contacts the indicator element; performing rotation of the collar, wherein rotation of the collar causes corresponding rotation of the absorbent material to disinfect the female connector, wherein rotation of the collar also causes the at least one rib element to remove a sufficient portion of the indicator element to expose the second visual indicator, thereby providing a visual indication that the female connector has been disinfected.

[0075] Throughout the specification, references to "one embodiment", "certain embodiments", "one or more embodiments", or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, phrases such as "in one or more embodiments", "in certain embodiments", "in one embodiment", or "in an embodiment" that appear throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Moreover, in one or more embodiments, the particular features, structures, materials, or characteristics may be combined in any suitable manner.

[0076] Although the disclosure herein has been provided with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and apparatuses of the present disclosure without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to embrace modifications and variations that fall within the scope of the appended claims and their equivalents.

Claims

1. A disinfection device for disinfecting a medical female connector, the disinfection device comprising: An absorbent material having a disinfectant or antibacterial agent; An inner housing having an inner wall and a first open end for receiving the absorbent material, wherein the medical female connector is inserted into the first open end and contacts the absorbent material; An outer housing having an outer wall and a second open end for receiving the inner housing, wherein the inner housing and the absorbent material are rotatable within the outer housing; An indicator element located between the outer wall and a transparent collar, the transparent collar having at least one rib element contacting the indicator element, wherein the indicator element includes a first visual indicator and a second visual indicator hidden by the first visual indicator; And A boss element extending from the inner wall and extending through the outer wall and the indicator element and attached to the collar, wherein rotation of the collar causes a corresponding rotation of the absorbent material to disinfect the medical female connector, and wherein rotation of the collar also causes the at least one rib element to remove a sufficient portion of the indicator element to expose the second visual indicator, thereby providing a visual indication that the medical female connector has been disinfected.

2. The disinfection device according to claim 1, wherein, The medical female connector is selected from the group consisting essentially of a needleless connector, a catheter Luer connector, a stopcock, or a hemodialysis connector.

3. The disinfection device according to claim 1, wherein, The medical female connector is a needleless connector having a passage surface, a septum, an interface surface, and an interface thread.

4. The disinfection device according to claim 1, wherein, The indicator element is a scratch card having a removable scratch surface.

5. The disinfection device according to claim 1, wherein, The indicator element includes an indicator surface manufactured using a removable foil layer.

6. The disinfection device according to claim 1, wherein The first visual indicator is a first color, and the second visual indicator is a second color.

7. The disinfection device according to claim 1, further comprising a plurality of flanges extending from the outer housing to facilitate user handling of the outer housing.

8. The disinfection device according to claim 1, wherein, The collar includes a plurality of raised gripping members to facilitate user gripping of the collar.

9. A disinfection device for disinfecting a medical female connector, the disinfection device comprising: An absorbent material having a disinfectant or antibacterial agent; An inner housing having an inner wall and a first open end for receiving the absorbent material, wherein the medical female connector is inserted into the first open end and contacts the absorbent material; An outer housing having an outer wall and a second open end for receiving the inner housing, wherein the inner housing and the absorbent material are rotatable within the outer housing, and wherein a plurality of flanges extend from the outer housing to facilitate user handling of the outer housing; An indicator element located between the outer wall and a transparent collar, the transparent collar having at least one rib element contacting the indicator element, wherein the indicator element includes a first visual indicator and a second visual indicator hidden by the first visual indicator; A boss element that extends from the inner wall and extends through the outer wall and the indicator element and is attached to the collar, wherein rotation of the collar causes corresponding rotation of the absorbent material to disinfect the medical female connector, and wherein rotation of the collar also causes the at least one rib element to remove a sufficient portion of the indicator element to expose the second visual indicator, thereby providing a visual indication that the medical female connector has been disinfected; and A ring member that is attached to the outer housing and is coupled to the collar by a plurality of frangible elements to form a tamper-resistant structure, wherein the frangible elements are configured to break when the collar is rotated with sufficient torque, and wherein the broken finger elements indicate that the collar has been rotated.

10. The disinfection device according to claim 9, wherein, The medical female connector is selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, or a hemodialysis connector.

11. The disinfection device according to claim 9, wherein, The medical female connector is a needleless connector having a passage surface, a septum, an interface surface, and interface threads.

12. The disinfection device according to claim 9, wherein, The indicator element is a scratch card having a removable scratch surface.

13. The disinfection device according to claim 9, wherein, The indicator element includes an indicator surface made using a removable foil layer.

14. The disinfection device according to claim 9, wherein, The collar includes a plurality of raised gripping members to facilitate a user in gripping the collar.

15. The disinfection device according to claim 9, wherein, The first visual indicator is a first color and the second visual indicator is a second color.

16. The disinfection device according to claim 9, wherein, The second open end forms an annular engagement surface, and the disinfection device further includes a peelable seal removably attached to the annular engagement surface to prevent the disinfectant or antimicrobial agent from leaving the disinfection device.

17. The disinfection device according to claim 9, wherein, The disinfectant or antimicrobial agent is selected from the group consisting essentially of: isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tertiary butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, ethanol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

18. The disinfection device according to claim 17, wherein, The disinfectant or antimicrobial agent includes at least one of chlorhexidine gluconate and chlorhexidine diacetate.

19. The disinfection device according to claim 18, wherein, The disinfectant or antimicrobial agent is a fluid or a gel.

20. A method for disinfecting a medical female connector, the method comprising: Providing a rotatable inner housing that includes an absorbent material having a disinfectant or antimicrobial agent; Providing an outer housing that receives the inner housing, wherein the inner housing and the absorbent material are rotatable within the outer housing; Providing an indicator element having a first visual indicator and a second visual indicator hidden by the first visual indicator; Providing a transparent collar having at least one rib element that contacts the indicator element; Perform rotation of the ferrule, wherein rotation of the ferrule causes corresponding rotation of the absorbent material to disinfect the medical female connector, and wherein rotation of the ferrule also causes the at least one rib element to remove a sufficient portion of the indicator element to expose the second visual indicator, thereby providing a visual indication that the medical female connector has been disinfected.

Images