Universal disposable caps for male and female connectors

Abstract

A device for connection to a medical connector includes an outer cap, an inner cap, and a peelable seal. The outer cap is configured to define a chamber for receiving absorbent material and a disinfectant or antimicrobial agent. The outer cap includes one or more threads adapted for engagement with a female Luer connector. The inner cap includes one or more threaded tabs adapted for engagement with a male Luer connector. The peelable seal prevents the disinfectant or antimicrobial agent from leaving the chamber.

Description

[0001] This application is a divisional application of Chinese patent application No. PCT / US2019 / 026482, Chinese application No. 201980035117.4, filed on April 9, 2019, entitled "Universal disposable caps for male and female connectors". Technical Field

[0002] This disclosure generally relates to an apparatus for sterilizing and disinfecting an inlet port using, for example, male and female Luer fittings, and particularly to a sterilization and disinfection apparatus capable of accommodating a variety of connector types. Background Technology

[0003] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. VADs are generally classified into two types: peripheral catheters and central venous catheters. Bacteria and other microorganisms can enter a patient's vascular system from the access seat and port / valve after being connected to a VAD to deliver fluids or medications. Each access seat (or port / valve or connector) carries the risk of spreading catheter-associated bloodstream infection (CRBSI), which can be costly and potentially fatal.

[0004] To reduce cases of catheter-related bloodstream infections (CRBSI) and ensure the proper use and maintenance of catheter-associated bloodstream infections (VADs), practice standards, including disinfection and cleaning procedures, have been established.

[0005] Sterilization caps have been added to the guidelines of the Society for Health Care Epidemiology (SHEA), and early indications suggest that they will also be included in the 2016 Infusion Nurse Standards (INS) guidelines.

[0006] In developed markets, when using IV catheters, needleless connectors are typically used to shut off the system, and then the connector is used via the catheter to administer medications or other necessary fluids to the patient. INS Practice Standards recommend the use of needleless connectors, stating that “they should be consistently and thoroughly disinfected with alcohol, iodine, or a chlorhexidine gluconate / alcohol mixture before each use.” Disinfection of needleless connectors ultimately aims to help reduce the proliferation of bacteria that may survive on the surface and potentially lead to various catheter-related complications, including the aforementioned CRBSI case. Nurses typically perform this disinfection task by using a 70% IPA alcohol pad and performing a known “swab seat.” However, compliance with this practice is generally low. In addition to the lack of compliance with the “swab seat,” interviews with clinicians have revealed discrepancies in wiping time, drying time, and the number of times the needleless connector is wiped.

[0007] Throughout procedures involving the spread of microorganisms that could lead to CRBSI, numerous risks of exposure or contamination exist. Contamination can occur during drug mixing, catheter connection, and insertion into the port. Because the procedure for connecting to a VAD is so common and straightforward, the risks associated with access to the patient's vascular system are often overlooked. Currently, the risks to the hospital and the patient are the primary concern of clinicians performing the connection, and this effort is largely uncontrollable.

[0008] Currently, caps for male needleless connectors, female needleless connectors, intravenous (IV) catheters, and hemodialysis catheters use different designs, thus limiting them to the types of connectors that can be attached to the cap. Existing sterilization caps are designed to fit only one type of connector and are specifically designed for connectors of a particular size and / or shape. Therefore, there is a need for a sterilization device that can accommodate multiple types of connectors to simplify the sterilization process. There is also a need for a sterilization device capable of continuous sterilization for several days. Summary of the Invention

[0009] One aspect of this disclosure relates to a device for connection to a medical connector. According to a first exemplary embodiment of this disclosure, the device generally includes an outer cap, an inner cap, and a peelable seal. In one or more embodiments, the outer cap includes a one-piece body, a closed end, and an annular wall having a length extending from the closed end to an open end defining a chamber. The chamber may contain absorbent material and a disinfectant or antimicrobial agent. The open end of the outer cap defines an end face. The annular wall of the outer cap includes an outer wall surface and an inner wall surface. The inner wall surface includes one or more threads. The inner cap includes a one-piece body having an annular wall having an outer wall surface and an inner wall surface, wherein a first end of the inner cap faces the closed end of the outer cap, and a second end of the inner cap faces the open end of the outer cap. The outer wall surface of the first end of the inner cap includes one or more threads that can engage with threads on the inner wall surface of the outer cap. The outer wall surface of the second end of the inner cap includes one or more threads adapted to engage a male Luer connector. When the threads of the inner cap engage with the male Luer connector, the threads of the outer cap will be inactive. Alternatively, the inner cap's threads will be inactive when the outer cap's threads engage with the female Luer connector. In one or more embodiments, a peelable seal may be placed on the end face to prevent disinfectant or antimicrobial agent from leaving the chamber.

[0010] When the device is removed from its packaging, in its initial state, the open end of the outer cap and the second end of the inner cap are on the same horizontal plane. To connect the device to the male Luer connector, the user applies an axial load to engage the male Luer connector with one or more threads on the outer wall surface of the second end of the inner cap and rotates it clockwise, causing the inner cap to partially extend from the open end of the outer cap. When the inner cap partially extends from the open end of the outer cap, there is no space between the device and the connector. When the male Luer connector engages with one or more threads on the outer wall surface of the second end of the inner cap and rotates it counterclockwise, the inner cap retracts into the chamber of the outer cap. When the female Luer connector engages with the device, the inner cap slides and retracts into the chamber of the outer cap. Once the device is engaged with the connector, it can be removed from the connector by rotating the device counterclockwise. After disengagement, the inner and outer caps remain attached to each other.

[0011] The device is designed to be compatible with a variety of disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent may include variants of alcohol or chlorhexidine. The disinfectant or antimicrobial agent may be a fluid or gel selected from the group consisting primarily of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexocide, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, oxytetracycline, antibiotics, and mixtures thereof.

[0012] In one or more embodiments, the outer wall surface of the cap includes a plurality of gripping members.

[0013] In one or more embodiments, the female connector may be a needleless connector, a stopcock valve, or a hemodialysis connector. In one or more embodiments, the male connector may be an intravenous catheter end or a stopcock valve.

[0014] Another aspect of this disclosure relates to a device for connection to a medical connector according to a second exemplary embodiment of this disclosure, the device typically including an outer cap, an inner cap, and a peelable seal.

[0015] The outer cap includes a body, a closed end, and an annular wall having a length extending from the closed end to an open end and defining a chamber for receiving absorbent material and a disinfectant or antibacterial agent. The open end defines an end face. The annular wall of the outer cap includes an outer wall surface and an inner wall surface. The inner wall surface includes one or more grooves and one or more threads adapted to engage with a female Luer connector. In one or more embodiments, the female connector may be in the form of a needleless connector, a stopcock valve, or a hemodialysis connector. In one or more alternative embodiments, the body of the outer cap may consist of two parts, wherein a rear end part having an inner cavity is screwed onto a front end part of the cap body by threads or welding.

[0016] The inner cap includes a body with an annular wall having an outer wall surface and an inner wall surface, wherein a first end of the inner cap faces the closed end of the outer cap. A second end of the inner cap faces the open end of the outer cap. The inner wall surface of the outer cap includes one or more grooves along which the inner cap can slide. The outer wall surface of the first end of the inner cap includes two axial wings to fit into one or more grooves on the inner wall surface of the outer cap to facilitate sliding movement while not allowing significant relative rotation of the inner cap relative to the outer cap. The outermost diameter of the thread of the inner cap is designed to have minimal interference with the thread of the outer cap (e.g., sliding fit or disassembly fit) to allow relatively linear movement and also facilitate assembly of the device. It is desirable that the tooth depth of the threads of the inner and outer caps is sufficient to engage with male and female Luer connectors. The outer wall surface of the second end of the inner cap includes one or more threaded tabs adapted to engage with a male Luer connector. In one or more embodiments, the outer wall surface of the second end of the inner cap includes two threaded tabs adapted to engage with a male Luer connector. The male Luer connector includes a collar with a female thread. In one or more embodiments, the male connector may be an intravenous (IV) tube end, a stopcock valve, or a male locking Luer.

[0017] The inner cap can slide back and forth relative to the outer cap. In one or more embodiments, in the initial state, the open end of the outer cap and the second end of the inner cap are on the same horizontal plane. When the male Luer connector engages with one or more threads on the outer wall surface of the second end of the inner cap, the inner cap slides against the outer cap to partially extend from the open end of the outer cap. When the female Luer connector engages with the device, the inner cap slides relative to the outer cap and retracts into the chamber of the outer cap to allow the female Luer connector to engage with one or more threads on the inner wall surface of the outer cap.

[0018] Currently available sterilization caps can only sterilize one of three types of Luer connectors: female Luer connectors for needleless connectors, female Luer connectors for stopcock valves, and male Luer connectors for intravenous injection sites. Therefore, to avoid having to use different types of sterilization caps to clean different types of connectors, this device adapts to different types of Luer connectors due to a sliding mechanism between the inner cap, which engages with the male Luer connector, and the outer cap, which engages with the female Luer connector, allowing the user to clean different types of connectors using a single device. When the outer cap is installed onto the female Luer connector, the inner cap retracts towards the chamber at the closed end of the outer cap, thus providing space for inserting and screwing the female Luer connector onto the threads of the outer cap. When the inner cap of the device is installed onto the male Luer connector, one or more threaded tabs on the outer wall surface of the second end of the inner cap engage with the threads on the male Luer connector. Therefore, the disclosed cap can be installed on both male and female Luer connectors.

[0019] When used on a Luer connector, the device can achieve disinfection by integrating a disinfectant or antimicrobial agent into the chamber of the outer cap. The disinfectant or antimicrobial agent may be contained directly in the chamber, or it may be absorbed into a sponge or foam material filling the chamber of the outer cap. In one or more embodiments, the disinfectant or antimicrobial agent is substantially selected from the group consisting of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexadiazine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, ostinidine, antibiotics, and mixtures thereof.

[0020] The peelable seal on the end face is used to prevent disinfectants or antimicrobial agents from leaving the room.

[0021] In one or more embodiments, the outer wall surface of the cap includes a plurality of gripping members.

[0022] The outermost diameter of one or more threaded tabs of the inner cap has minimal interference with the thread of the outer cap to allow for relatively linear movement.

[0023] Another aspect of this disclosure relates to a device for connection to a medical connector according to a third exemplary embodiment of this disclosure, the device generally comprising an outer cap, an inner cap, and a peelable seal.

[0024] The outer cap comprises a one-piece body, a closed end, and an annular wall having a length extending from the closed end to the open end and defining a chamber for containing absorbent material and disinfectant or antimicrobial agent. The open end defines an end face.

[0025] The annular wall of the outer cap includes an outer wall surface and an inner wall surface. The inner wall surface includes one or more grooves and one or more threads adapted to engage with a female Luer connector, wherein at least a portion of the one or more threads on the inner wall surface includes a gap that does not engage the mating features of the inner cap.

[0026] The inner and outer caps are slidably engaged. The inner cap includes a one-piece body having an annular wall with an outer wall surface and an inner wall surface, wherein a first end of the inner cap faces the closed end of the outer cap, and a second end of the inner cap faces the open end of the outer cap. The outer wall surface of the first end of the inner cap includes two axial wings to fit into one or more grooves on the inner wall surface of the outer cap and facilitate sliding movement while preventing significant relative rotation of the inner cap with respect to the outer cap. The outer wall surface of the second end of the inner cap includes one or more threaded tabs adapted to engage with a male Luer connector. The inner and outer caps are slidably arranged.

[0027] The removable seal on the end face prevents disinfectants or antimicrobial agents from leaving the room.

[0028] In one or more embodiments, in the initial state, the open end of the outer cap and the second end of the inner cap are located on the same horizontal plane.

[0029] When the male Luer connector engages with one or more threads on the outer wall surface of the second end of the inner cap and rotates clockwise, the inner cap partially protrudes from the open end of the outer cap.

[0030] When the male Luer connector engages with one or more threads on the outer wall surface of the second end of the inner cap and rotates counterclockwise, the inner cap retracts into the chamber of the outer cap.

[0031] When the female Luer connector is engaged with the device, the inner cap slides against the outer cap and retracts into the chamber of the outer cap to allow the female Luer connector to engage one or more threads on the inner wall surface of the outer cap.

[0032] In one or more embodiments, the outer wall surface of the second end of the inner cap includes two threaded tabs adapted to engage a male Luer connector having a collar with a female thread.

[0033] In one or more embodiments, the outer wall surface of the cap includes a plurality of gripping members.

[0034] In one or more embodiments, the female connector may be selected from the group consisting essentially of needleless connectors, catheter Luer connectors, stopcock valves, and hemodialysis connectors.

[0035] In one or more embodiments, the male connector may be an intravenous catheter end, a stopcock valve, or a male locking Luer.

[0036] In one or more embodiments, the threads of the inner cap and the outer cap do not interfere with each other to achieve a sliding fit.

[0037] In one or more embodiments, the gaps of the one or more threads on the inner wall surface of the outer cap are arranged near the grooves on the inner wall surface of the outer cap to allow the inner cap to slide against the outer cap.

[0038] When the inner cap slides against the outer cap, the gap of the one or more threads on the inner wall surface of the outer cap accommodates the one or more threaded tabs on the outer wall surface of the second end of the inner cap.

[0039] In one or more embodiments, two axial wings on the outer wall surface of the first end of the inner cap further include one or more pouch-like members having a snap-fit ​​arrangement that engages with one or more protrusions disposed on the one or more grooves on the inner wall surface of the outer cap to fix the position of the inner cap relative to the outer cap.

[0040] When the male Luer connector engages with the one or more threads on the outer wall surface of the second end of the inner cap and rotates clockwise, the one or more pouches on the two axial wings of the inner cap disengage from the one or more protrusions on the inner wall surface of the outer cap, allowing the inner cap to partially protrude from the open end of the outer cap.

[0041] When the female Luer connector is engaged with the device, the inner cap will be pushed, and one or more pouches on the two axial wings of the inner cap will disengage from one or more protrusions on the inner wall surface of the outer cap, so that the inner cap moves toward the closed end of the chamber.

[0042] In one or more embodiments, two axial wings on the outer wall surface of the first end of the inner cap further include one or more protrusions having a snap-fit ​​arrangement that engages with one or more corresponding pouch-like snaps arranged on one or more grooves on the inner wall surface of the outer cap to fix the position of the inner cap relative to the outer cap.

[0043] When the male Luer connector engages with one or more threads on the outer wall surface of the second end of the inner cap and rotates clockwise, one or more pouches on the two axial wings of the inner cap disengage from one or more protrusions on the inner wall surface of the outer cap, so that the inner cap partially protrudes from the open end of the outer cap.

[0044] When the female Luer connector is engaged with the device, the inner cap will be pushed, and one or more pouches on the two axial wings of the inner cap will disengage from one or more protrusions on the inner wall surface of the outer cap, so that the inner cap moves toward the closed end of the chamber.

[0045] The inner cap can slide back and forth relative to the outer cap. In one or more embodiments, in the initial state, the open end of the outer cap and the second end of the inner cap are on the same horizontal plane. When the male Luer connector engages with one or more threads on the outer wall surface of the second end of the inner cap, the inner cap slides against the outer cap to partially protrude from the open end of the outer cap. When the female Luer connector is engaged with the device, the inner cap slides against the outer cap and retracts into the chamber of the outer cap to allow the female Luer connector to engage with one or more threads on the inner wall surface of the outer cap. The threads of the inner cap and the outer cap are essentially non-interfering and no longer subject to interference constraints, enabling a sliding fit.

[0046] Currently available sterilization caps can only sterilize one of three types of Luer connectors: female Luer connectors for needleless connectors, female Luer connectors for stopcock valves, and male Luer connectors for intravenous injection sites. Therefore, to avoid having to use different types of sterilization caps to clean different types of connectors, this device adapts to different types of Luer connectors due to a sliding mechanism between the inner cap, which engages with the male Luer connector, and the outer cap, which engages with the female Luer connector, allowing the user to clean different types of connectors using a single device. Thus, to avoid having to use different types of sterilization caps to clean different types of connectors, the device disclosed herein and other embodiments provide a single device for cleaning different types of connectors. When the outer cap is installed onto the female Luer connector, the inner cap retracts towards the chamber at the closed end of the outer cap, thus providing space for inserting and screwing the female Luer connector onto the threads of the outer cap. When the inner cap of the device is installed onto the male Luer connector, one or more threaded tabs on the outer wall surface of the second end of the inner cap engage with the threads on the male Luer connector. Therefore, the disclosed cap can be installed on both male and female Luer connectors. The threads of the inner cap and the outer cap rarely interfere with each other or do not interfere with each other, and while meeting the Lur standard, the dimensions of the inner cap thread and the outer cap thread are independent of each other.

[0047] When used on a Luer connector, the device can achieve disinfection by integrating a disinfectant or antimicrobial agent into the chamber of the outer cap. The disinfectant or antimicrobial agent may be contained directly in the chamber, or it may be absorbed into a sponge or foam material filling the chamber of the outer cap. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexadiazine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanidine, antibiotics, and mixtures thereof. In one or more embodiments, the disinfectant or antimicrobial agent may be a fluid or a gel. In one or more embodiments, the absorbent material is compressed toward the closed end of the chamber when connected to the female or male Luer connector. The compression of the absorbent material sterilizes the female or male Luer connector.

[0048] The peelable seal on the end face prevents disinfectants or antimicrobial agents from leaving the room.

[0049] In one or more embodiments, the outer wall surface of the cap includes a plurality of gripping members.

[0050] Another aspect of this disclosure relates to a device for connection to a medical connector according to a fourth exemplary embodiment of this disclosure, the device generally comprising an outer cap, an inner cap, and a peelable seal.

[0051] The outer cap comprises a one-piece body, a closed end, and an annular wall having a length extending from the closed end to the open end and defining a chamber for containing absorbent material and disinfectant or antimicrobial agent. The open end of the outer cap defines an end face.

[0052] The annular wall of the outer cap includes an outer wall surface and an inner wall surface. The inner wall surface includes one or more pouch-like elements.

[0053] The inner cap includes a one-piece body having an annular wall with an outer wall surface and an inner wall surface, wherein a first end of the inner cap faces the closed end of the outer cap, and a second end of the inner cap faces the open end of the outer cap. The outer wall surface of the first end of the inner cap includes a flexible hinge adapted to engage one or more pouch-like elements on the inner wall surface of the outer cap to fix the position of the inner cap relative to the outer cap. The outer wall surface of the second end of the inner cap includes one or more threads adapted to engage a male Luer connector.

[0054] The removable seal on the end face prevents disinfectants or antimicrobial agents from leaving the room.

[0055] In one or more embodiments, in the initial state, the open end of the outer cap and the second end of the inner cap are located on the same horizontal plane.

[0056] In one or more embodiments, when the male Luer connector engages with one or more threads on the outer wall surface of the second end of the inner cap and rotates clockwise, the flexural hinge on the inner cap disengages from the pouch-like element on the inner wall surface of the outer cap to allow the inner cap to partially protrude from the open end of the outer cap.

[0057] In one or more embodiments, when the male Luer connector engages with one or more threads on the outer wall surface of the second end of the inner cap and rotates counterclockwise, the inner cap retracts into the chamber of the outer cap.

[0058] In one or more embodiments, when the female Luer connector is engaged with the device, the inner cap is pushed and the interlock between the flexural hinge on the inner cap and the pouch on the outer cap disengages, allowing the inner cap to move toward the closed end of the chamber.

[0059] In one or more embodiments, the disinfectant or antibacterial agent is selected from the group consisting of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexocide, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanidine, antibiotics, and mixtures thereof.

[0060] In one or more embodiments, the outer wall surface of the cap includes a plurality of gripping members.

[0061] In one or more embodiments, the female Luer connector is selected from the group consisting of needleless connectors, stopcock valves, and hemodialysis connectors.

[0062] In one or more embodiments, the male Luer connector may be an intravenous catheter end, a stopcock valve, or a male locking Luer.

[0063] Another aspect of this disclosure relates to a device for connection to a medical connector according to a fifth exemplary embodiment of this disclosure, the device generally comprising an outer cap, an inner cap, and a peelable seal.

[0064] The outer cap includes a one-piece body, a closed end, and an annular wall having a length extending from the closed end to an open end and defining a chamber for receiving absorbent material and a disinfectant or antimicrobial agent. The open end of the annular wall defines an end face. In one or more embodiments, the annular wall includes a flared curvature portion at the open end of the defined end face of the body. The annular wall of the outer cap includes an outer wall surface and an inner wall surface, the inner wall surface having one or more protrusions. The inner cap includes a one-piece body having an annular wall having an outer wall surface and an inner wall surface, wherein a first end of the inner cap faces the closed end of the outer cap, and a second end of the inner cap faces the open end of the outer cap. The outer wall surface of the first end of the inner cap includes a recess adapted to engage with one or more protrusions of the inner wall surface of the outer cap to fix the position of the inner cap relative to the outer cap. The outer wall surface of the second end of the inner cap includes one or more threaded tabs adapted to engage with a male Luer connector. A peelable seal on the end face prevents the disinfectant or antimicrobial agent from leaving the chamber.

[0065] In one or more embodiments, the outer surface of the cap may include markings, graphics, symbols, charts, text, or other instructions.

[0066] In one or more embodiments, in the initial state, the open end of the outer cap may be on the same horizontal plane as the second end of the inner cap.

[0067] When the male Luer connector engages with one or more threads on the outer wall surface of the second end of the inner cap and rotates clockwise, the inner cap partially protrudes from the open end of the outer cap.

[0068] When the male Luer connector engages with one or more threads on the outer wall surface of the second end of the inner cap and rotates counterclockwise, the inner cap retracts into the chamber of the outer cap.

[0069] When the female Luer connector engages with the device, the inner cap slides and retracts into the chamber of the outer cap.

[0070] In one or more embodiments, the disinfectant or antibacterial agent is selected from the group consisting of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexocide, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanidine, antibiotics, and mixtures thereof.

[0071] In one or more embodiments, the outer wall surface of the cap includes a plurality of gripping members.

[0072] In one or more embodiments, the female connector is selected from the group consisting of needleless connectors, stopcock valves, and hemodialysis connectors.

[0073] In one or more embodiments, the male connector may be an intravenous catheter end, a stopcock valve, or a male locking Luer. Attached Figure Description

[0074] Figure 1 A top perspective view of the device according to the first embodiment is shown;

[0075] Figure 2 It shows Figure 1 A bottom perspective view of the device shown.

[0076] Figure 3 A side view of the device according to the first embodiment is shown;

[0077] Figure 4 A side view of the outer cap is shown;

[0078] Figure 5 It shows Figure 1 A perspective side view of the inner cap of the device shown;

[0079] Figure 6 It shows Figure 1 A perspective bottom view of the inner cap of the device shown;

[0080] Figure 7 It shows Figure 1 Side view of the inner cap of the device shown;

[0081] Figure 8 It shows a material with absorbent material Figure 1 A cross-sectional view of the device shown;

[0082] Figure 9 The initial state is shown. Figure 1 A cross-sectional view of the device shown;

[0083] Figure 10 The Luer connector is shown when activated. Figure 1 A cross-sectional view of the device shown;

[0084] Figure 11 A bottom perspective view of the device according to the second embodiment is shown;

[0085] Figure 12 It shows Figure 11 Top perspective view of the device shown;

[0086] Figure 13 An exploded side perspective view of the device according to the second embodiment is shown;

[0087] Figure 14An exploded side view of the device according to the second embodiment is shown;

[0088] Figure 15 An exploded bottom perspective view of the device according to the second embodiment is shown;

[0089] Figure 16 A top perspective view of the outer cap of the device according to the second embodiment is shown;

[0090] Figure 17 A bottom perspective view of the outer cap of the device according to the second embodiment is shown;

[0091] Figure 18 A perspective view of the inner cap of the device according to the second embodiment is shown;

[0092] Figure 19 A perspective view of the device according to the second embodiment is shown;

[0093] Figure 20 A cross-sectional view of the inner cap of the device according to the second embodiment is shown;

[0094] Figure 21 A perspective view of the outer cap according to the third embodiment is shown;

[0095] Figure 22 A cross-sectional view of the device according to the third embodiment is shown;

[0096] Figure 23 A cross-sectional view of the outer cap of the device according to the third embodiment is shown;

[0097] Figure 24 A cross-sectional view of the device according to the third embodiment is shown;

[0098] Figure 25 A perspective view of the device according to the fourth embodiment is shown;

[0099] Figure 26 A cross-sectional view of the device according to the fourth embodiment is shown;

[0100] Figure 27 A cross-sectional view of the device according to the fourth embodiment is shown;

[0101] Figure 28 A perspective view of the device according to the fifth embodiment is shown;

[0102] Figure 29 A cross-sectional view of the device according to the fifth embodiment is shown;

[0103] Figure 30 A cross-sectional view of an apparatus having an absorbent material according to a fifth embodiment is shown;

[0104] Figure 31A perspective view of a device connected to a male Luer connector according to a fifth embodiment is shown;

[0105] Figure 32 A perspective view of a device connected to a female Luer connector according to a fifth embodiment is shown;

[0106] Figure 33 A perspective view of a device connected to a male Luer connector according to a fifth embodiment is shown;

[0107] Figure 34 A perspective view of a device connected to a female Luer connector according to a fifth embodiment is shown;

[0108] Figure 35 A perspective view of a female Luer connector with a diaphragm according to the prior art is shown;

[0109] Figure 36 A perspective view of a female Luer connector with a plug valve according to the prior art is shown;

[0110] Figure 37 A perspective view of a public Luer connector according to the prior art is shown;

[0111] Figure 38 A perspective view of a hemodialysis connector according to the prior art is shown. Detailed Implementation

[0112] Before describing several exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the details of the construction or process steps set forth in the following description. This disclosure can be other embodiments and can be practiced or implemented in different ways.

[0113] Embodiments of this disclosure relate to a universal disposable device for connecting to and sterilizing medical connectors, including male and female Luer connectors, wherein the device includes an outer cap and an inner Luer. The device provides a mechanical barrier for the connector and contains an antimicrobial agent for sterilization. The device of this disclosure allows practitioners to streamline the sterilization process.

[0114] The following definitions are provided for the terms used in this disclosure.

[0115] As used herein, the use of “a,” “an,” and “the” includes both singular and plural forms.

[0116] As used herein, the term “catheter-related bloodstream infection” or “CRBSI” refers to any infection resulting from the presence of a catheter or IV line.

[0117] As used herein, the term "Luer connector" refers to a connecting collar, a standard method of attaching syringes, catheters, hubed needles, IV tubing, etc., to each other. A Luer connector consists of male and female interlocking tubes that are slightly tapered to better hold them together, even through a simple pressure / torsion fit. Luer connectors may optionally include additional threaded outer edges for added strength. The male end of the Luer connector is typically associated with a flushing syringe and can interlock with and connect to the female end located on a vascular access device (VAD). The Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, and a molded central channel for fluid communication from the chamber of the syringe barrel to the seat of the VAD. The Luer connector also has a distal channel for releasably attaching the Luer connector to the seat of the VAD and a proximal channel for releasably attaching the Luer connector to the syringe barrel.

[0118] Reference Figure 1 -10, a device 100 for connection to a medical connector according to a first exemplary embodiment of the present disclosure generally includes an outer cap 102, an inner cap 132, and a peelable seal 150. In one or more embodiments, such as Figure 2 and Figure 4 As shown, the outer cap 102 includes an integral body 104, a closed end 106, and an outer cap annular wall 108, the outer cap annular wall having a length L extending from the closed end 106 to the open end 110 of the limiting chamber 112. O1 Chamber 112 may contain absorbent material 114 and disinfectant or antibacterial agent. The open end 110 of the outer cap 102 defines an end face 116. The annular wall 108 of the outer cap 102 includes an outer wall surface 118 and an inner wall surface 120. The inner wall surface 120 includes one or more threads 122 adapted to engage a female Luer connector. The inner cap 132 includes a one-piece body 134 having an annular wall 136 with an outer wall surface 138 and an inner wall surface 140, wherein a first end 142 of the inner cap faces the closed end 106 of the outer cap 102, and a second end 144 of the inner cap faces the open end 110 of the outer cap 102. The annular wall 136 of the inner cap has a length L extending from the first end 142 to the second end 144. I1 And less than the length L of the outer cap. O1The outer wall surface 138 of the first end 142 of the inner cap 132 includes one or more threads 146 to engage with threads 122 on the inner wall surface 120 of the outer cap 102. The outer wall surface 138 of the second end 144 of the inner cap 132 includes one or more threads 148 adapted to engage a male Luer connector. When the threads of the inner cap engage with the male Luer connector, the threads of the outer cap will be inactive. Alternatively, when the threads of the outer cap engage with the female Luer connector, the threads of the inner cap will be inactive. In one or more embodiments, a peelable seal 150 may be placed on the end face to prevent disinfectant or antimicrobial agent from leaving the chamber 112. In one or more embodiments, the peelable seal includes an aluminum or multilayer polymer film peelable top component. In one or more embodiments, the peelable seal 150 includes a moisture barrier.

[0119] When device 100 is removed from its packaging, in its initial state, the open end 110 of outer cap 102 lies on a horizontal plane P that is approximately the same as the second end 144 of inner cap 132. As used herein, the phrase "approximately the same horizontal plane P" refers to a position where the outer and inner caps are close to each other but the inner cap does not protrude relative to the outer cap. To connect the device to the male Luer connector, the user applies an axial load such that the male Luer connector engages one or more threads 148 on the outer wall surface 138 of the second end 144 of inner cap 132 and rotates clockwise, causing inner cap 132 to partially protrude from the open end of outer cap. When inner cap 132 partially protrudes from the open end 110 of outer cap 102, there is no space between the device and the connector. When the male Luer connector engages one or more threads 148 on the outer wall surface 138 of the second end 144 of inner cap 132 and rotates counterclockwise, inner cap 132 retracts into the chamber 112 of outer cap. In one or more embodiments, the male Luer connector can be detached from the device 100 by counterclockwise rotation without forcing the inner cap 132 to retract. When the female Luer connector is engaged with the device, the inner cap 132 slides and retracts into the chamber 112 of the outer cap 102. Once the device is engaged with the connector, it can be removed from the connector by counterclockwise rotation. Upon disengagement, the inner cap 132 and the outer cap 102 remain intact and attached to each other.

[0120] Device 100 is designed to be compatible with a variety of disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent may include a variant of alcohol or chlorhexidine. The disinfectant or antimicrobial agent may be a fluid or gel selected from the group consisting essentially of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexocide, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, oxytetracycline, antibiotics, and mixtures thereof.

[0121] In one or more embodiments, the absorbent material is compressed toward the closed end of the chamber when connected to the female or male Luer connector. The compression of the absorbent material sterilizes the female or male Luer connector.

[0122] The inner cap 132 and / or the outer cap 102 are made of any of a variety of plastic materials, such as polycarbonate, polypropylene, polyethylene, ethylene glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices.

[0123] In one or more embodiments, the outer wall surface 118 of the cap includes a plurality of gripping members 119.

[0124] In one or more embodiments, the female connector may be a needleless connector, a stopcock valve, or a hemodialysis connector. In one or more embodiments, the needleless connector is selected from Q-SYTLE connectors, MAXPLUS, MAXPLUS CLEAR, MAXZERO, ULTRASITE, CARESITE, INVISION-PLUS, SAFELINE, ONELINK, V-LINK, CLEARLINK, NEUTRACLEAR, CLAVE, MICROCLAVE, MICROCLAVE CLEAR, NEUTRON, NANOCLAVE, KENDALL, NEXUS, INVISION, VADSITE, BIONECTOR, etc. In one or more embodiments, the male connector may be an intravenous catheter tip or a stopcock valve.

[0125] Reference Figure 11-20, A device 200 for connection to a medical connector according to a second exemplary embodiment of this disclosure typically includes an outer cap 202, an inner cap 232, and a peelable seal. As further discussed herein, the device 200 is suitable for a wide range of Luer fittings, including closed female Luer, open female Luer, and male Luer fittings, while being capable of sterilizing medical devices, such as inlet ports including needleless connectors, male connectors on intravenous lines, stopcock valves, and hemodialysis connectors. The inner cap 232 is slidably arranged with the outer cap 202.

[0126] like Figure 12 As shown in -15, the outer cap 202 includes a main body 204, a closed end 206, and an outer cap annular wall 208, wherein the outer cap annular wall has a length L extending from the closed end 206 to the open end 210. O2 It defines a chamber 212 for containing absorbent material and disinfectant or antibacterial agent. An open end 210 defines an end face 216. The outer cap annular wall 208 includes an outer cap outer wall surface 218 and an outer cap inner wall surface 220. The outer cap inner wall surface 220 includes one or more grooves 224 and one or more threads 222 adapted to engage with a female Luer connector. In one or more embodiments, the female connector may be in the form of a needleless connector, a stopcock valve, and a hemodialysis connector. In one or more alternative embodiments, such as... Figure 12 As shown, the body 204 of the outer cap 202 may include two parts, wherein a rear end part having an inner cavity is screwed onto the front end part of the cap by threads or welding.

[0127] The inner cap 232 includes a body 234 having an annular wall 236 with an outer wall surface 238 and an inner wall surface 240, wherein a first end 242 of the inner cap faces the closed end 206 of the outer cap 202. A second end 244 of the inner cap 232 faces the open end 210 of the outer cap 202. The inner wall surface 220 of the outer cap includes one or more grooves 224 along which the inner cap 232 can slide. The outer wall surface 238 of the first end 242 of the inner cap 232 includes two axial wings 247 for fitting into the one or more grooves 224 of the inner wall surface 220 of the outer cap and facilitating sliding movement without causing significant relative rotation of the inner cap 232 relative to the outer cap 202. The outermost diameter of the thread of the inner cap is designed to have minimal interference with the thread of the outer cap, such as a slip fit or strip fit, to allow relatively linear movement and also facilitate the assembly of the device 200. The thread depth of the inner and outer caps should be sufficient to engage with the male and female Luer connectors. The outer wall surface 238 of the second end 244 of the inner cap 232 includes one or more threaded tabs 248 adapted to engage with the male Luer connector. In one or more embodiments, the outer wall surface 238 of the second end 244 of the inner cap 232 includes two threaded tabs 248 adapted to engage with the male Luer connector. The male Luer connector includes a collar with female threads. In one or more embodiments, the male connector may be an intravenous (IV) catheter tip, a stopcock valve, or a male-locking Luer.

[0128] The inner cap 232 is slidable relative to the outer cap 202. In one or more embodiments, in the initial state, the open end 210 of the outer cap 202 and the second end 244 of the inner cap 232 are located on the same horizontal plane P. When the male Luer connector engages with the one or more threaded tabs 248 on the outer wall surface 238 of the second end 244 of the inner cap 232, the inner cap 232 slides against the outer cap 202 to partially protrude from the open end of the outer cap 202. When the female Luer connector engages with the device 200, the inner cap 232 slides against the outer cap 202 and retracts into the chamber 212 of the outer cap 202 to allow the female Luer connector to engage with the one or more threads 222 on the inner wall surface 220 of the outer cap 202.

[0129] The inner cap 232 and / or the outer cap 202 are made of any of a variety of plastic materials, such as polycarbonate, polypropylene, polyethylene, ethylene glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices.

[0130] Currently available sterilization caps can only sterilize one of three types of Luer connectors: female Luer connectors for needleless connectors, female Luer connectors for stopcock valves, and male Luer connectors for intravenous injection sites. Therefore, to avoid having to use different types of sterilization caps to clean different types of connectors, the device 200 adapts to different types of Luer connectors due to a sliding mechanism between the inner cap that engages with the male Luer connector and the outer cap that engages with the female Luer connector, allowing the user to clean different types of connectors using a single device. As described above, when the outer cap 202 is installed onto the female Luer connector, the inner cap 232 retracts towards the chamber 212 at the closed end 206 of the outer cap 202, thus providing space for the female Luer connector to be inserted and screwed onto the threads 222 of the outer cap 202. When the inner cap 232 of the device 200 is installed onto the male Luer connector, the one or more threaded tabs 248 on the outer wall surface 238 of the second end 244 of the inner cap 232 engage with the threads on the male Luer connector. Therefore, the disclosed cap can be installed on both male and female Ruhr.

[0131] When the device 200 is used on the Luer connector, disinfection can be achieved by integrating a disinfectant or antimicrobial agent into the chamber of the outer cap. The disinfectant or antimicrobial agent may be contained directly in the chamber, or it may be absorbed into a sponge or foam material filling the chamber of the outer cap. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexadiazine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, ostinidine, antibiotics, and mixtures thereof.

[0132] The peelable seal on end face 216 is used to prevent disinfectant or antimicrobial agent from leaving chamber 212.

[0133] In one or more embodiments, the outer wall surface 218 of the cap includes a plurality of gripping members.

[0134] The outermost diameter of the one or more threaded tabs of the inner cap has minimal interference with the threads of the outer cap to allow for relative linear movement.

[0135] Reference Figure 21-24. A device 300 for connection to a medical connector according to a third exemplary embodiment of this disclosure typically includes an outer cap 302, an inner cap 332, and a peelable seal. As further discussed herein, the device 300 is suitable for a wide range of Luer fittings, including closed female Luer, open female Luer, and male Luer fittings, while being capable of sterilizing medical devices, such as inlet ports including needleless connectors, male connectors on intravenous lines, stopcock valves, and hemodialysis connectors. The inner cap 332 is slidably arranged with the outer cap 302.

[0136] The outer cap 302 includes an integral body 304, a closed end 306, and an annular wall 308, the annular wall having a length L extending from the closed end 306 to the open end 310. O3 It also defines a chamber 312 for containing absorbent material and disinfectant or antimicrobial agent. The open end defines an end face 316.

[0137] The annular wall of the outer cap includes an outer wall surface 318 and an inner wall surface 320. The inner wall surface includes one or more grooves 324 and one or more threads 322 adapted to engage with a female Luer connector, wherein at least a portion of the one or more threads 322 on the inner wall surface 320 includes one or more gaps 326 that do not engage with the mating features of the inner cap 332.

[0138] The inner cap 332 and the outer cap 302 are slidably engaged. The inner cap 332 includes an integral body 334 having an annular wall 336 with an outer wall surface 338 and an inner wall surface 340. A first end 342 of the inner cap 332 faces the closed end 306 of the outer cap 302, and a second end 344 of the inner cap 332 faces the open end 310 of the outer cap 302. The outer wall surface 338 of the first end 342 of the inner cap 332 includes two axial wings 347 for fitting into one or more grooves 324 of the inner wall surface 320 of the outer cap and facilitating sliding movement without allowing significant relative rotation between the inner cap 332 and the outer cap 302. The outer wall surface 338 of the second end 344 of the inner cap 332 includes one or more threaded tabs 348 adapted for engagement with a male Luer connector. The inner cap 332 and the outer cap 302 are in a slidably arranged configuration.

[0139] The function of the one or more gaps 326 is to accommodate one or more threaded tabs 348 adapted to engage the male Luer connector on the inner cap 332 during sliding motion. The positions of the one or more gaps 326 and the threads on the inner cap should be adjacent to the groove 324 to minimize the gap size and utilize the width of the groove 324 as part of the accommodating space. The threaded tabs 348 of the inner cap 332 and the threads 322 of the outer cap 302 are no longer constrained by interference, thus enabling a sliding fit. The thread dimensions can be optimized to maximize the engagement between the threaded tabs 348 of the inner cap 332 and the outer cap 302 with the corresponding connectors. This improves the mechanical properties of the device in terms of resistance to overload torque and axial separation forces when used with the connector, thus allowing the device to be more securely attached to the Luer connector.

[0140] The inner cap 332 and / or the outer cap 302 are made of any of a variety of plastic materials, such as polycarbonate, polypropylene, polyethylene, ethylene glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices.

[0141] The peelable seal on the end face is used to prevent disinfectants or antimicrobial agents from leaving the room.

[0142] In one or more embodiments, in the initial state, the open end 310 of the outer cap 302 and the second end 344 of the inner cap 332 are located on the same horizontal plane.

[0143] When the male Luer connector engages with one or more threads on the outer wall surface of the second end of the inner cap and rotates clockwise, the inner cap 332 partially protrudes from the open end 310 of the outer cap 302.

[0144] When the male Luer connector engages with one or more threaded tabs 348 on the outer wall surface 338 of the second end 344 of the inner cap 332 and rotates counterclockwise, the inner cap 332 retracts into the chamber 312 of the outer cap 302.

[0145] When the female Luer connector is engaged with the device 300, the inner cap 332 slides against the outer cap 302 and retracts into the chamber 312 of the outer cap 302 to allow the female Luer connector to engage the one or more threads 322 on the inner wall surface 320 of the outer cap 302.

[0146] In one or more embodiments, the outer wall surface 338 of the second end 344 of the inner cap 332 includes two threaded tabs 348 adapted to engage a male Luer connector having a collar with a female thread.

[0147] In one or more embodiments, the outer wall surface 318 of the cap includes a plurality of gripping members.

[0148] In one or more embodiments, the female connector may be selected from the group consisting of needleless connectors, catheter Luer connectors, stopcock valves, and hemodialysis connectors.

[0149] In one or more embodiments, the male connector may be an intravenous catheter, a stopcock valve end, or a male locking Luer.

[0150] In one or more embodiments, the threads of the inner cap and the outer cap do not interfere with each other to allow for a sliding fit.

[0151] In one or more embodiments, the gap 326 of the one or more threads 322 of the inner wall surface 320 of the outer cap is arranged near the groove 324 of the inner wall surface 320 of the outer cap to allow the inner cap 332 to slide against the outer cap 302.

[0152] When the inner cap 332 slides against the outer cap 302, the gap 326 of the one or more threads 322 on the inner wall surface 320 of the outer cap accommodates the one or more threaded tabs 348 on the outer wall surface 338 of the second end 344 of the inner cap 332.

[0153] In one or more embodiments, a snap-fit ​​mechanism may be introduced at the rear end of the inner cap 332 to lock it in place with the outer cap 302 so that it remains in place during assembly. This mechanism has interference such that the force generated by tightening the inner cap onto the male connector can displace the inner cap, and the force generated by pushing the inner cap through the female connector can also displace the inner cap.

[0154] In one or more embodiments, the two axial wings 347 on the outer wall surface 338 of the first end 342 of the inner cap further include one or more pouches 349 having a snap-fit ​​arrangement, wherein one or more protrusions 380 are arranged on one or more grooves 324 on the inner wall surface 320 of the outer cap to fix the position of the inner cap 332 relative to the outer cap 302.

[0155] When the male Luer connector engages with one or more threaded tabs 348 on the outer wall surface 338 of the second end 344 of the inner cap 332 and rotates clockwise, one or more pouches 349 on the two axial wings 347 of the inner cap 332 disengage from one or more protrusions 380 on the inner wall surface 320 of the outer cap, allowing the inner cap 332 to partially protrude from the open end 310 of the outer cap 302.

[0156] When the female Luer connector is engaged with the device, the inner cap 332 will be pushed, and one or more pouches 349 on the two axial wings 347 of the inner cap 332 will disengage from one or more protrusions 380 on the inner wall surface 320 of the outer cap, so as to allow the inner cap 332 to move toward the closed end 306 of the outer cap and into the chamber 312.

[0157] In one or more embodiments, the two axial wings 347 on the outer wall surface 338 of the first end 342 of the inner cap 332 further include one or more protrusions 380 having a snap-fit ​​arrangement, wherein one or more corresponding pouch-like elements 349 are arranged on one or more grooves 324 on the inner wall surface 320 of the outer cap to fix the position of the inner cap 332 relative to the outer cap 302.

[0158] The inner cap 332 is slidable relative to the outer cap 302. In one or more embodiments, in the initial state, the open end 310 of the outer cap 302 and the second end 344 of the inner cap 332 are located on the same horizontal plane P. When the male Luer connector engages with one or more threaded tabs 348 on the outer wall surface 338 of the second end 344 of the inner cap 332, the inner cap 332 slides against the outer cap 302 to partially protrude from the open end 310 of the outer cap 302. When the female Luer connector engages with the device 300, the inner cap 332 slides against the outer cap 302 and retracts into the chamber 312 of the outer cap 302 to allow the female Luer connector to engage with one or more threads 322 on the inner wall surface 320 of the outer cap 302. The threaded tabs 348 of the inner cap 332 and the threads 322 of the outer cap 302 are essentially non-interfering with each other and are no longer constrained by interference, enabling a sliding fit.

[0159] Currently available sterilization caps can only sterilize one of three types of Luer connectors: female Luer connectors for needleless connectors, female Luer connectors for stopcock valves, and male Luer connectors for intravenous injection sites. Therefore, to avoid having to use different types of sterilization caps to clean different types of connectors, the device 300 adapts to different types of Luer connectors due to a sliding mechanism between the inner cap 332, which engages with the male Luer connector, and the outer cap 302, which engages with the female Luer connector, allowing the user to clean different types of connectors with a single device. Thus, to avoid having to use different types of sterilization caps to clean different types of connectors, the device 300 and other embodiments of this disclosure provide a single device for cleaning different types of connectors. When the outer cap 302 is installed onto the female Luer connector, the inner cap 332 retracts towards the chamber 312 at the closed end 306 of the outer cap 302, thus providing space for inserting and tightening the female Luer connector onto the threads 322 of the outer cap. When the inner cap of device 300 is installed onto a male Luer connector, one or more threaded tabs 348 on the outer wall surface 338 of the second end 344 of the inner cap 332 engage with the threads on the male Luer connector. Therefore, the disclosed cap can be installed on both male and female Luer connectors. The threads of the inner cap and the outer cap are essentially independent of each other, and the dimensions of the threads of the inner cap and the outer cap are independent of each other while simultaneously meeting the Luer standard.

[0160] When used on a Luer connector, device 300 can achieve disinfection by integrating an absorbent material containing a disinfectant or antimicrobial agent into the chamber 312 of the outer cap 302. The disinfectant or antimicrobial agent may be contained directly in the chamber, or it may be absorbed into a sponge or foam material filling the chamber of the outer cap. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chlorobenzylphenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexadiazine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, ostinidine, antibiotics, and mixtures thereof. In one or more embodiments, the disinfectant or antibacterial agent may be a fluid or a gel. In one or more embodiments, the absorbent material is compressed toward the closed end of the chamber when connected to the female or male Luer connector. The female or male Luer connector is disinfected by compressing the absorbent material.

[0161] A peelable seal on end face 316 prevents disinfectant or antimicrobial agent from leaving chamber 312.

[0162] In one or more embodiments, the outer wall surface 318 of the cap includes a plurality of gripping members.

[0163] Reference Figure 25 -27. A device 400 for connecting to a medical connector according to a fourth exemplary embodiment of the present disclosure generally includes an outer cap 402, an inner cap 432, and a peelable seal.

[0164] The outer cap 402 includes an integral body 404, a closed end 406, and an outer cap annular wall 408, the outer cap annular wall having a length L extending from the closed end 406 to the open end 410. O4 It defines a chamber 412 for containing absorbent material and disinfectant or antimicrobial agent. The open end 410 of the outer cap 402 defines an end face 416.

[0165] The outer cap annular wall 408 includes an outer cap outer wall surface 418 and an outer cap inner wall surface 420. The outer cap inner wall surface 420 includes one or more pouch-like elements 460.

[0166] The inner cap 432 includes a one-piece body 404 having an annular wall 436 having an outer wall surface 438 and an inner wall surface 440, wherein a first end 442 of the inner cap faces the closed end of the outer cap, and a second end 444 of the inner cap faces the open end of the outer cap. The outer wall surface of the first end of the inner cap includes a flexible hinge 470 adapted to engage one or more pouch-like pieces 460 of the inner wall surface 420 of the outer cap to fix the position of the inner cap 432 relative to the outer cap 402. The outer wall surface 438 of the second end 444 of the inner cap includes one or more threaded tabs 448 adapted to engage with a male Luer connector.

[0167] In one or more embodiments, the inner cap 432 is connected to the inner surface 420 of the outer cap via an elastic element designed as a flexible hinge 470, such as... Figure 26 As shown. The flexural hinge is a relatively long cantilever hinge connected to the inner cap. The hinge assembly also includes two flexural members configured to hold the inner cap 432 to the outer cap 402 together. Each flexural member includes a first portion connected to the inner cap and a second portion connected to one or more pouch-like members 449 formed in the inner surface 420 of the annular wall of the outer cap 402. As used herein, the flexural hinge 470 is a hinge that allows movement by bending the load element. In one embodiment, the flexural hinge 470 is made of any suitable plastic material capable of moving the inner cap 432 relative to the outer cap 402. In one or more embodiments, the flexural hinge 470 is made of a recurvature material that does not degrade or fail.

[0168] In one or more embodiments, the flexural hinge 470 may be made of a plastic material, preferably such as injection-molded polypropylene or ultra-high molecular weight polyethylene (UHMW-PE), whose material properties allow for short flex lengths while allowing for a large number of flexural motion cycles.

[0169] A peelable seal on end face 416 prevents disinfectant or antimicrobial agent from leaving chamber 412.

[0170] In one or more embodiments, in the initial state, the open end 410 of the outer cap 402 and the second end 444 of the inner cap 432 are located on the same horizontal plane.

[0171] When the male Luer connector engages one or more threaded tabs 448 on the outer wall surface 438 of the second end 444 of the inner cap 432, and the connector is rotated clockwise when viewed from the open end of the cap, the flexural hinge 470 on the inner cap disengages from the pouch 449 on the inner wall surface 420 of the outer cap, allowing the inner cap 432 to partially protrude from the open end 410 of the outer cap 402. When the male Luer connector engages one or more threaded tabs 448 on the outer wall surface 438 of the second end 444 of the inner cap 432 and rotates counterclockwise, the inner cap 432 retracts into the chamber 412 of the outer cap 402.

[0172] When the female Luer connector is engaged with the device, the inner cap 432 will be pushed, and the interlock between the flexural hinge 470 on the inner cap and the pouch 449 on the outer cap will disengage, allowing the inner cap 432 to move toward the closed end 406 of the outer cap and into the chamber 412.

[0173] The inner cap 432 and / or the outer cap 402 are made of any of a variety of plastic materials, such as polycarbonate, polypropylene, polyethylene, ethylene glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices.

[0174] In one or more embodiments, the disinfectant or antibacterial agent is selected from the group consisting of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexocide, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanidine, antibiotics, and mixtures thereof.

[0175] In one or more embodiments, the outer wall surface 418 of the cap includes a plurality of gripping members 419.

[0176] In one or more embodiments, the female Luer connector may be selected from the group consisting of a needleless connector, a stopcock valve, and a hemodialysis connector.

[0177] In one or more embodiments, the male Luer connector may be an intravenous catheter end, a stopcock valve, or a male locking Luer.

[0178] Reference Figure 28 -34. A device 500 for connecting to a medical connector according to a fifth exemplary embodiment of the present disclosure generally includes an outer cap, an inner cap, and a peelable seal.

[0179] The outer cap 502 includes an integral body 504, a closed end 506, and an annular wall 508, the annular wall having a length L extending from the closed end 506 to the open end 510. O5 The body defines a chamber 512 for containing absorbent material 514 and a disinfectant or antibacterial agent. An open end of the body defines an end face 516. In one or more embodiments, the annular wall includes a flared curvature at the open end of the defining end face 516 of the body. In one or more embodiments, the integral body 504 of the outer cap has a geometry modified to reduce the outer diameter and height of the outer cap. This reduction in size and weight lowers the risk of interfering with patient movement and irritating the patient's skin. The Luer threads on the inner cap are designed not to interfere with the threads on the outer cap, while simultaneously not additionally cutting into the outer cap threads, thereby simplifying the molding process.

[0180] The outer cap annular wall 508 includes an outer cap outer wall surface 538 and an outer cap inner wall surface 540, the inner wall surface 540 having one or more protrusions 580. The inner cap 532 includes an integral body 534 having an annular wall 536 having an outer wall surface 538 and an inner wall surface 540, wherein a first end 542 of the inner cap faces the closed end of the outer cap, and a second end 544 of the inner cap faces the open end of the outer cap. The outer wall surface of the first end of the inner cap includes a recess 590 adapted to engage with one or more protrusions on the inner wall surface of the outer cap to fix the position of the inner cap relative to the outer cap. The outer wall surface of the second end of the inner cap includes one or more threaded tabs 548 adapted to engage with a male Luer connector. A peelable seal 550 on the end face 516 prevents disinfectant or antimicrobial agent from leaving the chamber 512.

[0181] In one or more embodiments, in the initial state, the open end of the outer cap may be on the same horizontal plane as the second end of the inner cap.

[0182] When the male Luer connector engages with one or more threaded tabs 548 on the outer wall surface 538 of the second end 544 of the inner cap 532 and rotates clockwise, the inner cap 532 partially protrudes from the open end 510 of the outer cap 502.

[0183] When the male Luer connector engages with one or more threaded tabs 548 on the outer wall surface of the second end of the inner cap and rotates counterclockwise, the inner cap 532 retracts into the chamber 512 of the outer cap 502.

[0184] When the female Luer connector is engaged with the device, the inner cap 532 slides and retracts into the chamber 512 of the outer cap 502.

[0185] In one or more embodiments, the disinfectant or antibacterial agent is selected from the group consisting of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexocide, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanidine, antibiotics, and mixtures thereof.

[0186] In one or more embodiments, the outer surface 518 of the cap may include markings, graphics, symbols, diagrams, text, or other instructions.

[0187] In one or more embodiments, a curvature portion is added to the outer wall surface 518 of the cap. In one or more embodiments, a plurality of gripping members 519 are added to the outer wall surface 518 of the cap to enhance grip. In one or more embodiments, the plurality of gripping members 519 may be in the form of ribs.

[0188] The inner cap 532 and / or the outer cap 502 are made of any of a variety of plastic materials, such as polycarbonate, polypropylene, polyethylene, ethylene glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices.

[0189] like Figure 32 and 34 As shown, in one or more embodiments, the female connector 620 is selected from the group consisting of a needleless connector, a stopcock valve, and a hemodialysis connector.

[0190] like Figure 31 and 33 As shown, in one or more embodiments, the male connector 610 may be an intravenous catheter end, a stopcock valve, or a male locking Luer.

[0191] Reference Figures 35 to 38 In one or more embodiments, the cap of the device of this disclosure forms a fluid-impermeable seal with the female Luer connector 700, the male Luer connector 800, or the hemodialysis connector 900. See also... Figures 35 to 38In one or more embodiments, the cap of the device disclosed herein is tapered to form a fluid-impermeable seal with the male Luer connector 800. In certain embodiments, the cap conforms to ISO standards (e.g., ISO 594-1:1986 and ISO 594-2:1998) for forming a seal with the male Luer.

[0192] In one or more embodiments, the cap of the device disclosed herein has threads sized and pitched to engage a threadable segment of a female connector, such as a female Luer connector. In medical applications, such connectors are typically and generally used as protective connectors for catheters and other fluid-impermeable devices. In some embodiments, the cap provides a protective cover for the female Luer connector when engaged with the connector, as the threads from the female Luer connector engage the threads of the cap and form a releasable connection with the cap's threads.

[0193] In some embodiments, the connector includes a needleless injection portion, which may sometimes be referred to as a needleless injection port, seat, valve, or device, or as a needleless entry portion, port, seat, valve, or device, and may include brands such as... (Available from ICU Medical Ltd.) (Available from Cardinal Health Ltd.) and Q-Syte TM (Available from BD). In some embodiments, the cap can be attached to any of a variety of different needle-free injection sites (such as those previously listed). In one or more embodiments, after the cap is attached to the connector, it is not necessary to sterilize the connector (e.g., treat it with an alcohol swab) before each reconnection to another connector, because the connector is kept uncontaminated and simultaneously attached to the cap. The cap is used instead of the standard wiping protocol for cleaning the connector.

[0194] In one or more embodiments, the thread size and pitch of the cap are configured to engage with the thread of a male Luer lock connector. For example, the connector may include an end of a venous tubing assembly disconnected from the needleless injection site of a venous catheter.

[0195] Throughout this specification, references to "one embodiment," "some embodiments," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with that embodiment is included in at least one embodiment of this disclosure. Therefore, phrases appearing throughout the specification such as "in one or more embodiments," "in some embodiments," "in one embodiment," or "in one embodiment" do not necessarily refer to the same embodiment of this disclosure. Furthermore, in one or more embodiments, particular features, structures, materials, or characteristics may be combined in any suitable manner.

[0196] While this disclosure provides a description with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of this disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and apparatus of this disclosure without departing from the spirit and scope of this disclosure. Therefore, it is intended that this disclosure include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A device for connecting to a medical connector, the device comprising: An outer cap comprising a unitary body, a closed end, an outer cap annular wall having a length L extending from the closed end to an open end O1 and defining a chamber, the chamber containing an absorbent material, and the chamber containing a disinfectant or an antiseptic, the open end defining an end face; the outer cap annular wall having an outer cap outer wall surface and an outer cap inner wall surface, the outer cap inner wall surface having one or more threads, wherein the one or more threads on the outer cap inner wall surface of the outer cap have threads adapted to engage with a female luer connector; an inner cap comprising a unitary body having an inner cap annular wall having an outer wall surface and an inner wall surface, wherein a first end of the inner cap faces a closed end of the outer cap, a second end of the inner cap faces the open end of the outer cap, the outer wall surface of the first end of the inner cap has one or more threads to engage with the threads on the outer cap inner wall surface of the outer cap, the outer wall surface of the second end of the inner cap has one or more threads adapted to engage with a male luer connector; and a peelable seal on the end face to prevent the sterilizing or antiseptic agent from exiting the chamber.

2. The apparatus of claim 1, wherein, The inner cap annular wall has an inner cap length L I1 extending from the first end to the second end and is less than a length L O1 of the outer cap.

3. The apparatus of claim 1, wherein, In an initial state, the open end of the outer cap is at approximately the same horizontal plane as the second end of the inner cap.

4. The apparatus of claim 1, wherein, When a male luer connector engages the one or more threads of the outer wall surface of the second end of the inner cap and is rotated in a clockwise direction, the inner cap partially protrudes from the open end of the outer cap.

5. The apparatus of claim 1, wherein, When a male luer connector engages the one or more threads of the outer wall surface of the second end of the inner cap and is rotated in a counter-clockwise direction, the inner cap retracts into the chamber of the outer cap.

6. The apparatus of claim 1, wherein, When a female luer connector engages the device, the inner cap slides and retracts into the chamber of the outer cap.

7. The apparatus of claim 1, wherein, the sterilizing or antiseptic agent is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole, butylated hydroxytoluene, tert-butyl hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzethonium chloride, octenidine, antibiotics, and mixtures thereof.

8. The apparatus of claim 1, wherein, the sterilizing or antiseptic agent is a fluid or a gel.

9. The apparatus of claim 1, wherein, Upon connection to the female luer connector or the male luer connector, the absorbent material is compressed towards the closed end of the chamber.

10. The apparatus of claim 9, wherein, The female luer connector or the male luer connector is sterilized by compressing the absorbent material.

11. The apparatus of claim 1, wherein, the outer cap outer wall surface comprises a plurality of gripping members.

12. The apparatus of claim 1, wherein, the female luer connector is a needleless connector.

13. The apparatus of claim 1, wherein, the male luer connector is an intravenous tubing end or a stopcock valve.

14. The apparatus of claim 1, wherein, the peelable seal comprises an aluminum or a multi-layer polymeric film peel top.

15. The apparatus of claim 1, wherein, the female luer connector is a stopcock valve.

16. The apparatus of claim 1, wherein, the female luer connector is a hemodialysis connector.

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