Disinfection cap for medical device

Abstract

The present application relates to a disinfection cap for a medical device. The present application relates to a disinfection cap or device for disinfecting a medical connector. The cap includes a visual indicator that changes color after the clinician has spent sufficient scrubbing effort and time to disinfect the medical device, thereby providing positive visual feedback to the therapeutic clinician. The housing of the cap includes a disinfecting medium, such as a disinfecting sponge coupled to the rotating collar. The housing is oriented such that the sponge contacts the medical device to be cleaned. Rotation of the collar in turn causes the disinfection sponge to rotate against the VAD, providing a scrubbing action. A visualization chamber within the cap contains two different colors of isolation fluids. When the collar rotates, it mixes two isolated fluids, thereby changing the color of the mixture. When the visualization chamber displays a new third mixed color, the medical device is disinfected.

Description

Technical Field

[0001] The present disclosure generally relates to a sterilization cap for a medical device. More particularly, the present disclosure generally relates to a sterilization cap for a medical device that indicates that sterilization and disinfection of the medical device is complete. Background Art

[0002] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. There are two general classifications of VADs: peripheral catheters and central venous catheters. When delivering fluids or medications, bacteria and other microorganisms can enter the patient's vascular system from the access hub, port, or valve when connected to the VAD. Each access hub, port, valve, or connection carries the risk of spreading catheter-related bloodstream infection (CRBSI), which is costly and potentially fatal.

[0003] To reduce CRBSI cases and ensure proper use and maintenance of VADs, standards of practice have been developed that include sterilization and cleaning processes. Sterilization caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines, and sterilization caps have also been incorporated into the Infusion Nurses Standards (INS) guidelines.

[0004] In developed markets, when IV catheters are used, needleless connectors are often used to close the system and then administer medication or other necessary fluids to the patient through the catheter. The INS standard of practice recommends the use of needleless connectors and states that "continuous and thorough disinfection with alcohol, iodine, or a chlorhexidine gluconate / alcohol combination should be performed before each use." Disinfection of needleless connectors is ultimately intended to help reduce bacteria that can grow on surfaces and can cause various catheter-related complications, including CRBSI. Nurses often complete disinfection tasks using a 70% isopropyl alcohol (IPA) pad through the so-called "swabbing the hub." However, compliance with this practice is often low. In addition to non-compliance with the "swabbing the hub" rule, interviews with clinicians also noted that there is often variation in scrub time, drying time, and the number of times needleless connectors are scrubbed.

[0005] There are many risks of contact or contamination throughout the process associated with the transmission of microorganisms that can cause CRBSI. Contamination can occur during medication mixing, cannula attachment, and insertion into the access hub. Because the process of connecting a VAD is so common and simple, the risks associated with accessing the patient's vascular system are often overlooked. Currently, the risk to hospitals and patients depends substantially on the diligence of the clinician making the connection, which is largely uncontrollable. In particular, it has been found that healthcare providers may not fully understand the impact of not adhering to scrub protocols. Therefore, healthcare providers may not disinfect the hub within the recommended time. Utility Model Content

[0006] One aspect of the present disclosure relates to a disinfection cap or device for disinfecting VADs and other medical devices that provides positive visual feedback to a treating clinician when disinfection is complete. The cap includes a visual indicator that changes color after the clinician has spent sufficient scrubbing effort and time to disinfect the VAD. The outer housing of the cap includes a disinfection medium, such as a disinfection sponge impregnated with a disinfectant or antimicrobial agent, which is coupled to a rotating collar. The outer housing is oriented in a stationary position so that the sponge contacts the VAD to be cleaned. Repeated rotation of the collar rotates the disinfection sponge against the VAD, thereby providing a scrubbing action. The visualization chamber of the cap contains two isolated fluids of different colors. As the collar rotates, it mixes the two isolated liquids, changing the color of the resulting mixture to a third color to indicate that the medical device being cleaned has been disinfected. When the visualization chamber displays the third final mixed color, the clinician has sufficiently scrubbed the VAD to disinfect it and can remove the currently cleaned cap. The visualization chamber provides positive feedback to the treating clinician, eliminating uncertainty as to whether the cleaned device has been properly disinfected.

[0007] In an exemplary embodiment of the present disclosure, a disinfection cap for a medical device includes an outer shell having a disinfection medium, such as a disinfection sponge. A rotatable collar is coupled to the disinfection medium for rotating the medium. A visualization chamber is confined within the outer shell and visible outside the outer shell. The corresponding first and second different colored fluids are kept isolated from each other in the visualization chamber. A mixer in the visualization chamber is coupled to the collar for mixing the first and second colored fluids when the collar rotates. The rotation of the collar rotates the disinfection medium relative to the medical device to be disinfected. The collar rotation also mixes the first and second colored fluids and changes them to a third color visible outside the outer shell. The clinician receives visual feedback that the disinfection of the medical device is complete through the color change. In some embodiments, the first and second colored fluids in the visualization chamber are isolated from each other by a membrane. Then, during the rotation of the collar, the mixer destroys the membrane so that the previously separated pair of colored fluids can be mixed.

[0008] Another exemplary embodiment of the present disclosure relates to a disinfection cap for a medical device, which includes an outer shell having a proximal end and a disinfection cavity in the open distal end of the shell. The inner shell in the disinfection cavity can rotate around a first rotation axis. The inner shell has an open distal end and a proximal end that are communicated with the open distal end of the outer shell. The disinfection medium is oriented in the inner shell. The collar is rotatably coupled to the proximal end of the outer shell around a second rotation axis coaxial with the first rotation axis. A shaft oriented coaxially with the first and second rotation axes is coupled to the proximal end of the inner shell and coupled to the collar. The disinfection cap includes a visualization chamber, which is defined in the proximal end of the outer shell and the inner surface of the collar. The visualization chamber is visible outside the collar. The first chamber and the second chamber are oriented in the visualization chamber, respectively containing corresponding different first and second colored fluids. The diaphragm is inserted between the first chamber and the second chamber and isolates them from each other. The mixer in the visualization chamber is coupled to the inner surface of the collar. The mixer destroys the membrane when the collar rotates, causing the first and second colored fluids that are no longer isolated to mix with each other. The rotation of the collar scrubs the medical device being cleaned with the disinfecting medium and also mixes the first and second colored fluids. When the first and second colored fluids mix, they change to a third color, which is visible outside the outer housing. When the clinician observes the third color within the visualization chamber, he or she knows that the medical device being cleaned is now disinfected and no further rotation of the collar is required.

[0009] Another exemplary embodiment of the present disclosure relates to a method for sterilizing a medical device by contacting the medical device with a sterilizing medium held within an outer housing of a sterilizing cap. The outer housing is held in a stationary position, wherein a sterilizing medium, such as a sterilizing sponge, is held in contact with the medical device. The medical device is sterilized by rotating a collar coupled to the sterilizing medium so that the sterilizing medium scrubs the medical device. The collar is rotatably coupled to the outer housing. A visualization chamber defined within the outer housing is observed from the outside of the outer housing. The visualization chamber holds respective first and second colored fluids isolated from each other therein. The second colored fluid is a different color from the first colored fluid. The first colored fluid and the second colored fluid are mixed together within the visualization chamber by a mixer, which is coupled to the collar. As the collar rotates, the first and second colored fluids are mixed to change to a third color different from the first and third colors, because the sterilizing medium also rotates against and scrubs the medical device. The treating clinician stops the collar rotation when the third color is seen, giving visual feedback that the medical device is now sterilized.

[0010] Another exemplary embodiment of the present disclosure relates to a method for sterilizing a medical device, characterized in that the method includes: contacting the medical device with a sterilizing medium held within an outer shell of a sterilizing cap while holding the outer shell in a stationary position relative thereto; sterilizing the medical device by rotating the sterilizing medium, wherein the sterilizing medium has a collar coupled thereto, the collar being rotatably coupled to the outer shell; observing a visualization chamber at least partially defined within the outer shell from outside the outer shell, the visualization chamber holding corresponding different first and second colored fluids therein and isolating them from each other, the first and second colored fluids having a first color and a second color, respectively, the second color being different from the first color; mixing the first and second colored fluids together using a mixer directed within the visualization chamber, the mixer being coupled to the collar, so that the mixed first and second colored fluids become a third color different from the first and second colors; and stopping the collar rotation when the third color within the visualization chamber is observed.

[0011] The method further includes: capturing the medical device in the sterilization cavity formed in the open distal end of the outer shell before contacting the medical device with the sterilization medium oriented in the sterilization cavity; sterilizing the medical device by contacting the medical device with the sterilization medium while rotating the sterilization medium, wherein the collar is coupled to the visualization cavity by an axis passing through it, and the collar is rotatably coupled to the proximal end of the outer shell; observing the visualization cavity defined in the open distal end of the outer shell and in the collar from outside the outer shell, the visualization cavity containing respective first and second chambers isolated from each other by a membrane, wherein the respective first and second chambers retain respective first and second colored fluids therein; disrupting the membrane with the mixer by rotating the collar, thereby mixing the first and second colored fluids together with the mixer and causing them to become the third color; stopping the collar rotation when the third color in the visualization cavity is observed; and then separating the sterilization cavity from the medical device.

[0012] The method further includes repeatedly rotating the collar clockwise and counterclockwise to scrub the medical device and mix the first colored fluid and the second colored fluid together.

[0013] One aspect of the present disclosure relates to a disinfection cap for a medical device, characterized in that the disinfection cap comprises:

[0014] an outer housing having an open distal end;

[0015] a disinfecting medium within the outer housing in communication with the open distal end of the outer housing;

[0016] a rotatable collar coupled to the disinfecting medium;

[0017] a visualization chamber defined at least in part within the outer housing and visible outside the outer housing;

[0018] corresponding different first and second colored fluids, having first and second colors, respectively, maintained in isolation from one another within the visualization chamber; and

[0019] and a mixer within the visualization chamber, the mixer being coupled to the rotatable collar for mixing the respective first and second colored fluids as the rotatable collar rotates, wherein the rotation of the rotatable collar mixes the respective first and second colored fluids and changes them to a third color visible outside the outer housing.

[0020] The disinfection cap also includes:

[0021] a first chamber and a second chamber within the visualization chamber, which contain the first coloring fluid and the second coloring fluid, respectively;

[0022] a membrane that is interposed between the first chamber and the second chamber and isolates the first chamber and the second chamber from each other; and

[0023] The mixer disrupts the film and mixes the respective different first and second colored fluids with each other as the rotatable collar rotates.

[0024] The mixer includes a cutter for disrupting the film.

[0025] The cutter is coupled to an interior surface of the rotatable collar, wherein the interior surface of the rotatable collar forms at least a portion of the visualization chamber.

[0026] At least a portion of the rotatable collar includes a translucent or transparent material for externally observing the color of the fluid within the visualization chamber.

[0027] said outer housing having a sterile cavity in said open distal end thereof and a proximal end;

[0028] The sterilization medium is directed within the sterilization cavity;

[0029] The rotatable collar is rotatably coupled to the proximal end of the outer housing and to the sterilizing medium via a shaft; and

[0030] The visualization lumen is defined within the proximal end of the outer housing and an interior surface of the rotatable collar and is visible outside of the rotatable collar.

[0031] The visualization chamber defines therein a first chamber for holding the first colored fluid and a second chamber for holding the second colored fluid, the first chamber and the second chamber being separated by a membrane within the visualization chamber, the mixer destroying the membrane when the rotatable ring rotates and causing the corresponding different first colored fluid and second colored fluid to mix with each other and become the third color.

[0032] The sterilization cap also includes wherein the membrane is oriented within the visualization chamber at an acute angle relative to an axis of rotation of the rotatable collar.

[0033] The first coloring fluid includes glycerin and a first coloring dye, and the second coloring fluid includes glycerin and a second coloring dye.

[0034] The disinfection cap also includes:

[0035] an inner housing disposed within the sterilization cavity and holding the sterilization medium; and

[0036] A shaft is coupled to the inner housing and the rotatable collar for rotating the inner housing.

[0037] The shaft passes through the visualization chamber.

[0038] The disinfection medium includes a disinfection sponge.

[0039] The sterilization cap further includes a peelable tear sheet covering the open distal end of the outer shell to isolate the sterilization cavity from the surrounding environment.

[0040] One aspect of the present disclosure relates to a disinfection cap for a medical device, characterized in that the disinfection cap comprises:

[0041] an outer housing having a proximal end and a sterile cavity in an open distal end thereof;

[0042] an inner housing within the sterile cavity rotatable about a first axis of rotation, the inner housing having an open distal end communicating with the open distal end of the outer housing and a proximal end; and

[0043] a disinfecting medium within the inner housing;

[0044] a collar rotatably coupled to the proximal end of the outer housing about a second rotational axis coaxial with the first rotational axis;

[0045] a shaft coaxial with the first and second rotational axes, the shaft coupled to the proximal end of the inner housing and to the collar;

[0046] a visualization chamber defined within the proximal end of the outer housing and an interior surface of the collar and visible outside the collar;

[0047] a first chamber and a second chamber within the visualization chamber, the first chamber and the second chamber respectively containing corresponding different first colored fluids and second colored fluids;

[0048] a membrane that is interposed between the first chamber and the second chamber and isolates the first chamber and the second chamber from each other; and

[0049] and a mixer within the visualization chamber, the mixer being coupled to the interior surface of the collar, the mixer disrupting the membrane and mixing the corresponding different first colored fluid and second colored fluid with each other when the collar is rotated, wherein the rotation of the collar mixes the corresponding different first colored fluid and second colored fluid and changes them to a third color visible outside the outer housing.

[0050] The disinfection medium includes a disinfection sponge.

[0051] The disinfectant or antimicrobial agent includes at least one of chlorhexidine gluconate and chlorhexidine diacetate. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Exemplary embodiments of the present disclosure are further described in the following detailed description in conjunction with the accompanying drawings, in which:

[0053] Figure 1 is an isometric view of a disinfection cap of the present disclosure;

[0054] Figure 2 yes Figure 1 An axial cross-sectional view of a disinfection cap;

[0055] Figure 3 yes Figure 1 An exploded view of the disinfection cap;

[0056] Figure 4 yes Figure 1 An isometric view of the collar of a sterilization cap;

[0057] Figure 5yes Figure 1 An axial cross-sectional view of a sterilization cap of FIG. 1 having an empty visualization chamber showing the collar in a first rotational position;

[0058] Figure 6 yes Figure 5 an axial cross-sectional view of a sterilization cap showing isolated first and second fluids in a visualization chamber separated by a membrane;

[0059] Figure 7 yes Figure 6 axial cross-sectional view of the sterilization cap of , showing the collar in a second rotational position, rupture of the diaphragm, and partial mixing of the first and second fluids;

[0060] Figure 8 yes Figure 7 An axial cross-sectional view of a disinfection cap of FIG. 1, which shows complete mixing of the first and second fluids and the resulting color change;

[0061] Fig. 9 Before cleaning catheter port medical devices Figure 1 Isometric view of a sterilization cap;

[0062] Fig.10 yes Fig. 9 An isometric view of a sterilization cap after cleaning a catheter port type medical device before removing the cap; and

[0063] Fig.11 is a flow chart depicting a method of the present disclosure for sterilizing a medical device utilizing a sterilization cap.

[0064] To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. The figures are not drawn to scale. DETAILED DESCRIPTION

[0065] Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and can be practiced or carried out in various ways.

[0066] Embodiments of the present disclosure relate to a disinfection cap or device for disinfecting a medical connector, such as a vascular access device (VAD) or other medical device. Various exemplary types of medical devices are described below, which will be cleaned using the disinfection cap of the present disclosure. The disinfection cap of the present disclosure includes a visual indicator that changes color after the clinician has spent enough scrubbing effort and time to disinfect the medical device, thereby providing positive visual feedback to the treating clinician. The housing of the cap includes a disinfection medium, such as a disinfection sponge coupled to a rotating collar. The housing is oriented so that the sponge contacts the medical device to be cleaned. The collar rotates (e.g., by repeatedly rotating in a clockwise and counterclockwise sequence) to rotate the disinfection sponge against the VAD, thereby providing a scrubbing action. A visualization chamber in the cap contains two different colors of isolation fluids that can be observed outside the cap. When the collar rotates, it mixes the two separated fluids, changing the color of the resulting mixture to a third color. When the visualization chamber displays a new third mixed color, the medical device is disinfected.

[0067] In the present disclosure, a convention is followed wherein the distal end of a device is the end closest to the patient, e.g., for delivering one or more drugs to the patient, and the proximal end of the device is the end away from the patient and closest to a clinician or other medical practitioner. With respect to the terms used in the present disclosure, the following definitions are provided.

[0068] As used herein, the use of “a,” “an,” and “the” includes both the singular and the plural.

[0069] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection caused by the presence of a catheter or intravenous line.

[0070] As used herein, the term "Luer connector" refers to a connecting collar of a medical device (e.g., a VAD), which is a standard method of attaching syringes, catheters, collared needles, IV tubing, etc. to each other. The Luer connector consists of interlocking tubes of convex and concave types, slightly tapered to better hold together even with a simple press / twist fit. The Luer connector can optionally include an additional threaded outer edge to make it safer. The convex end of the Luer connector is generally associated with a flushing syringe and can be interlocked and connected to a concave 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 barrel of the syringe to the hub of the vascular access device (VAD). The Luer connector also has a distal end channel and a proximal end channel, the distal end channel attaching the Luer connector to the hub of the VAD in a releasable manner, and the proximal end channel attaching the Luer connector to the barrel of the syringe in a releasable manner.

[0071] As used herein, ISO 80369-7:2016 defines specifications for standard Luer connectors, including a 6% taper between the distal end and the proximal end. The male standard Luer connector increases from the open distal end to the proximal end. The female standard Luer connector decreases from the open proximal end to the distal end. According to ISO 80369-7:2016, the male standard Luer connector has an outer cross-sectional diameter of 0.75 mm measured between 3.970 mm and 4.072 mm from the distal end of the tip. The length of the male standard Luer taper is between 7.500 mm and 10.500 mm. The outer cross-sectional diameter of 7.500 mm is measured between 4.376 mm and 4.476 mm from the distal end of the tip. As used herein, the terms "male standard Luer connector" and "female standard Luer connector" shall refer to connectors having the dimensions described in ISO 80369-7, which is hereby incorporated by reference in its entirety.

[0072] As will be readily understood by those skilled in the relevant art, although descriptive terms such as "tip", "hub", "thread", "protrusion / insertion", "tab", "inclined surface", "wall", "top", "side", "bottom" and others are used throughout the specification to facilitate understanding, they are not intended to limit any components that can be used in combination, or used alone, or require a specific spatial orientation to implement the various aspects of the embodiments of the present disclosure.

[0073] According to another exemplary embodiment of the present disclosure, a needleless connector type medical device to be cleaned may include internal threads and / or external threads, the internal threads being of a specific size and having a thread pattern to engage with a standard ISO594-2 type male fitting, and the external threads being of a specific size and having a thread pattern to engage with a standard ISO 594-2 type female fitting. An example of an ISO594-2 type fitting is a Q-type fitting.

[0074] In one or more embodiments, the female connector type medical device to be cleaned can be selected from the group consisting of: a needle connector (for direct injection into a patient or insertion into a vial for drawing a dose of medicine therefrom), a needleless connector, a catheter Luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the needleless connector is selected from the group consisting of a Q-type TM connector, a MaxPlus, a MaxPlus Clear, a MaxZeroTM, OneLink, V-Link, ClearLink, NeutraClearTM, Clave, Clear, Clave Neutron, KendallTM、Nexus、

[0075] In one or more embodiments, the male connector type medical device to be cleaned may be an IV line end or a stopcock.

[0076] The following non-limiting examples illustrate the principles of one or more embodiments of the present disclosure. Referring now to the drawings, Figures 1 to 6 1 is a diagram showing a first aspect of the present disclosure illustrating its structural components and their interactions. The disinfection cap 20 of the present disclosure may also be referred to herein alternatively as a disinfection device or cap. Figures 1 to 3 , the disinfection cap 20 includes an outer shell 22, which has a first open distal end 24 and a first proximal end 26. A collar 28 is coupled to the first proximal end 26 and is rotatable in clockwise and counterclockwise directions (see arrows CW and CCW) around an axis coaxial with the centerline of the outer shell 22, wherein the collar may be cup-shaped. The first open distal end 24 of the outer shell 22 is sealed with a peelable tear-off sheet 30, which is removable in the direction of the arrow P, and the peelable tear-off sheet isolates the disinfection cap from the surrounding (external) environment until it is removed.

[0077] Sterilization cap 20 comprises inner housing 32, and it is oriented in the sterilization cavity 46 of outer housing 22.Inner housing 32 can rotate in clockwise and counterclockwise direction (referring to arrow CW and CCW) around the axis coaxial with the center line of outer housing 22 and the axis of rotation of collar 28.Inner housing 32 has second open distal end 34 and has second proximal end 38, and second open distal end 34 is communicated with inner housing cavity 36.Inner housing cavity comprises sterilization medium, such as sterilization sponge 39, and it is penetrated by disinfectant or antimicrobial agent.Axle 40 (also referred to as mounting stud) couples second proximal end 38 and collar 28 of inner housing 32, so that the rotation of collar also makes inner housing rotate.Axle 40 is oriented to be coaxial with the center line of the axis of rotation of collar 28, inner housing 32 and outer housing 22. The shaft 40 extends axially toward the collar 28 , through an open-ended fluid cavity 42 and a through hole 44 formed in the first proximal end 26 of the outer housing 22 .

[0078] A tear seal 48 (also referred to herein as a membrane) is sealed around the shaft 40 and along the axial peripheral edge of the fluid cavity 42, wherein the tear seal 48 may be membrane-shaped. The tear seal is made of a hydrophobic plastic material. The tear seal 48 is oriented at an acute angle relative to the centerline of the outer housing 22 and the common coaxial rotation axis of the collar 28 and the inner housing 32.

[0079] Specific reference Figure 2 , Figure 3 and Figure 6 , the disinfection cap 20 forms a visualization chamber 49 in the fluid cavity 42 inside the first proximal end 26 of the outer shell 22 and the collar 28. In certain embodiments, the collar 28 is made of clear or transparent material so that the visualization chamber 49 is visible outside the disinfection cap 20 and its outer shell 22. In other embodiments, the collar is configured with a clear or transparent window for observing the visualization chamber. The visualization chamber 49 includes a first chamber 50 and a second chamber 54, the first chamber 50 being oriented on the distal side of the tear seal 48 in the fluid cavity 42, and the second chamber being located on the proximal side of the tear seal, in the inside of the collar 28. The first chamber 50 contains a first colored fluid 52 (e.g., red), and the second chamber 54 contains a second colored fluid 56 (e.g., blue) that is different from the first colored fluid. Therefore, the first colored fluid 52 is isolated from the second colored fluid 56 by the tear seal 48.

[0080] refer to Figure 4 and Figure 5 , the inner wall surface 58 of the collar 28 includes a mixer or cutter 60 that protrudes axially toward the fluid cavity 42 within the visualization chamber 49. In a new, unused sterilization cap 20, the cutter 60 is positioned within the second chamber 54, out of contact with the tear seal 48. The inner wall surface 58 of the collar 28 also includes a collar mounting stud 68 that is coupled to the mounting shaft 40 so that rotation of the collar simultaneously rotates the inner housing 32 within which the sterilization sponge 39 is secured and the cutter 60 relative to the tear seal 48.

[0081] Figures 5 to 8 The interaction of the rotating mixer / cutter 60 with the tear seal 48 is shown, and how this interaction results in a visual color change within the visualization chamber 49 . Figure 5 The visualization chamber 49 is shown without any colored fluid in the first chamber 50 and the second chamber 54, which are isolated from each other by an intact tear seal 48. Figure 6 , the isolated first chamber 50 and the second chamber 54 are filled with a first colored fluid 52 (e.g., red) and a second colored fluid 56 (e.g., blue), respectively. When the intact tear seal 48 maintains the isolation of the colored fluids, only the second colored fluid 56 is visible through the proximal axial end of the collar 28. Figure 6 In the color example of FIG. 4 , a clinician viewing the transparent or translucent collar 28 sees only the blue colored visualization chamber 49 .

[0082] Reference now Figure 7As the clinician rotates the collar 28 while maintaining the remainder of the sterilization cap 20 stationary, the arcuate cutting motion of the mixer / cutter 60 cuts or otherwise disrupts the structural integrity of the tear seal 48, thereby allowing mixing of the first colored fluid 52 and the second colored fluid 56. Repeated clockwise and counterclockwise rotation of the collar 28, as indicated by the bidirectional arrow R, continues mixing and homogenizing the first colored fluid 52 and the second colored fluid 56.

[0083] Reference now Figure 8 After repeated rotations of the collar 28, the homogenized fluid becomes a fluid of a third color, namely a mixed secondary color 70. Using the example of a red-colored first colored fluid 52 and a blue-colored second colored fluid 56, as shown in FIG. Figure 8 As shown, their mixture produces a purple fluid as the mixed secondary color 70. In other embodiments, different pairs of first and second fluid primary colors are selected; when mixed, they become other secondary colors. For example, in another embodiment, a pair of primary colors selected for each corresponding first chamber 50 and second chamber 54 in the visualization chamber 49 is yellow and blue, which mix to form a secondary color green. In other embodiments, the primary color pair is red and yellow, which mix to form a secondary color orange. In one aspect of the present disclosure, different primary color pairs / secondary color combinations are selected for the visualization chamber 49 for different disinfection scrubbing times of the disinfection sponge 39. For example, one color combination is used for a 10-second disinfection cycle and another is used for a 30-second disinfection cycle.

[0084] The time and number of rotation cycles required to sufficiently homogenize the first fluid 52 and the second fluid 56 to change them to the third color, the mixed secondary color 70 varies depending on the selected fluid composition, density, and viscosity. The homogenization time and number of rotation cycles required to change the color of the liquid to the mixed secondary color 70 corresponds to the selected time and the scrubbing effort required to sterilize the medical device while rotating the disinfection sponge 39. According to one aspect of the present disclosure, the number of revolutions of the collar 28 required to homogenize the first colored fluid 52 and the second colored fluid 56 corresponds to the amount of scrubbing action of the disinfection sponge 39 required to sterilize a portion of the medical device. Thus, the visualization chamber 49 of the disinfection cap 20 provides a passive visual indication to the medical clinician user that the disinfection of the medical device to be cleaned is complete.

[0085] When using the disinfection cap 20, during the relative rotation of the coupled inner shell 33 / sponge 39 and the collar 28, the outer shell 22 is maintained in a stationary position. In order to assist the stationary positioning of the outer shell 22, it combines the shell gripping ribs 62 and the shell gripping wings 64, so that the disinfection cap 20 can be held without slipping by the treating clinician's single hand. Similarly, the collar 28 includes the collar gripping ribs 66, so that it can be rotated with the clinician's other hand. For example, the treating clinician maintains the outer shell 22 in a stationary position by maintaining the shell gripping ribs 62 and / or the gripping wings 64, and selectively rotates the collar 28 by gripping the collar gripping ribs 66. In one or more embodiments, the outer shell 22 and / or the collar 28 include additional gripping enhancement features, such as a textured surface.

[0086] like Figures 1 to 5 As shown, after generally describing the structural components of the disinfection cap 20 and the interaction of these components, various embodiments of each component are described in more detail below. The more detailed description of specific components is exemplary in nature and is not intended to limit the overall description and understanding of the present disclosure.

[0087] In one or more embodiments, the tear-off tab 30 is a peelable seal including an aluminum peel-off top or a multi-layer polymer film peel-off top. The tear-off tab 30 minimizes potential particulate hazards and also provides a substantially impermeable enclosure for the outer housing 22, providing a leak-proof and protective closure to protect the absorbed, infiltrated contents of the disinfectant sponge 39 or other disinfectant medium contained in the disinfection cavity 46, and / or maintain a sealed, sterile environment. The tear-off tab 30 provides sufficient sealing within the range of expected temperature, pressure, and humidity levels in the medical treatment facility. In one or more embodiments, the tear-off tab 30 includes an aluminum peel-off top or a multi-layer polymer film peel-off top. In some embodiments, the tear-off tab 30 is heat-sealed or induction-sealed to the first open distal end 24 of the outer housing 22.

[0088] The disinfection sponge 39 or other alternative absorbent material held within the inner housing 32 includes an absorbed or permeated liquid or gel, disinfectant or antimicrobial agent for disinfecting the medical device to be cleaned with the disinfection cap 20. In one or more embodiments, the absorbent material is a nonwoven material, foam or sponge having a porous structure. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment, the absorbent material is a sponge.

[0089] The disinfectant sponge 39 is held in its porous structure by surface tension and releases the disinfectant or antimicrobial agent when being squeezed or compressed by contacting with the medical device to be cleaned by the disinfection cap 20. The disinfection cap 20 is compatible with the interaction of various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent may include a variant of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent is substantially selected from the group including the following: isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics and mixtures thereof. In certain embodiments, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or gel. In one or more specific embodiments, the disinfectant or antimicrobial agent is 70% isopropyl alcohol (IPA).

[0090] In aspects of the present disclosure, the density of the first colored fluid 52 and the second colored fluid 56, and their mixing properties are changed into a third color, a mixed secondary color 70, to determine both the mixing time and the corresponding time for disinfection by the disinfection medium / sponge 39. The density and other chemical properties of the first colored fluid 52 and the second colored fluid 56 are adjusted as required to achieve the required disinfection scrubbing time of the disinfection cap 20. In aspects of the present disclosure, glycerol fluid is used as a mixed fluid in the visualization chamber 49 due to its higher density and miscible properties. Glycerol also has antimicrobial and antiviral properties. Glycerol is widely used in medical, pharmaceutical and personal care products. Glycerol is easily miscible with water and alcohol, and can be well mixed with color dyes. Its density is relatively high, about 1.26g / cc, low price, biodegradable, non-toxic, and non-irritating to the human digestive system, skin and mucous membranes.

[0091] The components of the disinfection cap 20 are made of any of a variety of medical grade plastic materials, such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile-butadiene-styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the disinfection cap 20 includes polypropylene or polyethylene materials.

[0092] refer to Figure 3 and Figures 9 to 11Various aspects of the present disclosure relate to methods for disinfecting surfaces of medical devices, such as needleless connectors (NFC), any other type of needleless connector, catheter Luer connectors, stopcocks, hemodialysis connectors, and other types of vascular access devices (VADs), including, but not limited to peripheral catheters and central venous catheters. For the purpose of illustrating these methods, a method of disinfecting surfaces of medical devices such as needleless connectors (NFC), any other type of needleless connector, catheter Luer connectors, stopcocks, hemodialysis connectors, and other types of vascular access devices (VADs) will now be described. Fig. 9 The exemplary disinfection cap 20 of the present disclosure when used to disinfect a catheter port 72 includes a hub portion having an outer hub surface that is generally frustoconical or cylindrical and axially symmetrical about a central axis. The hub portion of the catheter port 72 also includes an access surface that includes a septum 74. The access surface and the septum 74 are oriented substantially transverse to the central axis of the catheter port 72. Fig. 9 In the embodiment shown in FIG. 1 , the central axis of the disinfection cap 20 is coaxially aligned with the central axis of the catheter port 72 in a spaced relationship.

[0093] refer to Figure 3 and Fig. 9 as well as Fig.11 100, in step 102, a treating clinician who is to sterilize a catheter port 72 and its septum 74 peels off the tear-off tab 30 from the first open distal end 24 of the outer shell 22 of the sterilization cap 20, as indicated by arrow P. The intact tear-off tab 30 indicates that the sterilization cap 20 has not been previously used to clean a medical device. By observing the visualization chamber 49 through the rotatable collar 28 comprising a translucent or transparent material, the initial visible color of the second colored fluid 56 is the primary blue color. This means that the second colored fluid 56 remains isolated from the first colored fluid 52 in the visualization chamber 49. In addition to the intact tear-off tab 30, the blue color of the second colored fluid 56 indicates to the clinician that the sterilization cap 20 has not been previously used to clean a medical device. Fig.10 In step 104 of flowchart 100, the clinician advances the axially aligned sterilization cavity 46 of the sterilization cap 20 onto the catheter port 72 type medical device using the gripping ribs 62 and / or gripping wings 64 of the outer housing 22 until the sterilization sponge 39 contacts and presses against the septum 74. The clinician holds the outer housing 22 of the sterilization cap 20 in a stationary position relative to the catheter port 72, such as by gripping the housing gripping ribs 62 and / or gripping wings 64. According to aspects of the present disclosure, compression of the sterilization sponge 39 releases the sterilant or antimicrobial agent from the sponge or other absorbent material, allowing the sterilant or antimicrobial agent to contact the septum 74 and the surrounding surfaces of the port 72.

[0094] As previously described, the rotation of the collar 28 of the disinfection cap 20, such as Fig.10As shown by the double arrow R in the flowchart 100 and step 106, by virtue of their mechanical coupling through the shaft 40, a corresponding rotation of the inner housing 32 is caused, thereby causing a rotation of the disinfectant sponge 39. According to one aspect of the present disclosure, in steps 106 and 108, the collar 28 is sequentially and repeatedly rotated clockwise and counterclockwise by the clinician grasping the collar gripping ribs 66 while observing the color of the fluid in the visualization chamber 49. The rotation of the collar 28 causes the disinfectant sponge 39 to frictionally engage against the septum 74 and related surfaces to provide a scrubbing action that actively disinfects them. The twisting, rotational motion of the disinfectant sponge 39 increases the disinfection activity compared to using a 70% isopropyl alcohol (IPA) impregnated pad alone. In one or more embodiments, in addition to the passive chemical disinfection of the septum 74 and related surfaces due to contact between the liquid or gel disinfectant or the antimicrobial agent extruded by the disinfectant sponge 39, there is also active disinfection due to the rotation of the collar 28. The advantage of using the disinfection cap 20 of the present disclosure is that it utilizes the chemical disinfectant squeezed out by the disinfection sponge 39 (passive disinfection) and the scrubbing action of the sponge (active mechanical disinfection) to disinfect the medical device. Therefore, the combination of passive disinfection and active disinfection leads to an improvement in the disinfection effect. The washing step of the medical device can be performed for about 10-15 seconds to achieve a minimum log reduction (>4log) of microorganisms. In various aspects of the present disclosure, after performing the desired amount of disinfectant scrubbing (e.g., the number of seconds of mechanical mixing and scrubbing activity of a specific amount of scrubbing by the collar 28 rotation), the visualization chamber 49 changes color.

[0095] As previously described, the rotation of the collar 28 simultaneously causes the mixer / cutter 60 within the visualization chamber 49 to break the tear seal 48, thereby mixing the first colored fluid 52 and the second colored fluid 56 together, causing the mixed first colored fluid and the second colored fluid to become a third color, which is a mixed secondary color 70 different from the first color and the second color.

[0096] Referring to step 110 of flowchart 100, the clinician stops the rotation of the collar 28 when the visible color in the visualization chamber 49 changes from the initial primary color of the second colored fluid 56 to the mixed secondary color 70. According to aspects of the present disclosure, the number of rotations of the collar 28 required to change the visible color in the visualization chamber 49 from the initial primary color of the second colored fluid 56 to the mixed secondary color 70 corresponds to the amount of scrubbing action and scrubbing time required to disinfect the septum 74 and its associated surfaces. Thus, the visualization chamber 49 of the disinfection cap 20 device provides a passive visual indication to the treating clinician that disinfection of the septum 74 is complete. At step 112 of flowchart 100, the clinician removes the disinfection cap 20 from the now cleaned catheter port 72 after observing that the mixed secondary color 70 is visible in the visualization chamber 49 in step 110.

[0097] In some embodiments, the disinfection cap 20 further comprises a tamper-proof structure 23 that indicates whether the collar 28 has been rotated. The tamper-proof structure 23 according to some embodiments comprises a sticker or a peel-off label or a tearable label.

[0098] In this 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 conjunction with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearance of phrases such as "in one or more embodiments," "in certain embodiments," "in an embodiment," or "in an embodiment" in various places throughout the specification does not necessarily refer to the same embodiment of the present disclosure. Furthermore, in one or more embodiments, the particular features, structures, materials, or characteristics may be combined in any suitable manner.

[0099] Although the disclosure herein has provided a description with reference to embodiments, it should be understood that these specific embodiments are merely illustrations of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and changes may be made to the methods and facilities of the present disclosure without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to include modifications and changes within the scope of the appended claims and their equivalents.

Claims

1. A disinfection cap for medical devices, characterized in that: The disinfection cap comprises: an outer housing having an open distal end; a disinfecting medium within the outer housing in communication with the open distal end of the outer housing; a rotatable collar coupled to the disinfecting medium; a visualization chamber defined at least in part within the outer housing and visible outside the outer housing; corresponding different first and second colored fluids, having first and second colors, respectively, maintained in isolation from one another within the visualization chamber; and and a mixer within the visualization chamber, the mixer being coupled to the rotatable collar for mixing the respective first and second colored fluids as the rotatable collar rotates, wherein the rotation of the rotatable collar mixes the respective first and second colored fluids and changes them to a third color visible outside the outer housing.

2. The disinfection cap according to claim 1, characterized in that: The disinfection cap also includes: a first chamber and a second chamber within the visualization chamber, which contain the first coloring fluid and the second coloring fluid, respectively; a membrane that is interposed between the first chamber and the second chamber and isolates the first chamber and the second chamber from each other; and The mixer disrupts the film and mixes the respective different first and second colored fluids with each other as the rotatable collar rotates.

3. The disinfection cap according to claim 2, characterized in that: The mixer includes a cutter for disrupting the film.

4. The disinfection cap according to claim 3, characterized in that: The cutter is coupled to an interior surface of the rotatable collar, wherein the interior surface of the rotatable collar forms at least a portion of the visualization chamber.

5. The disinfection cap according to claim 4, characterized in that: At least a portion of the rotatable collar includes a translucent or transparent material for externally observing the color of the fluid within the visualization chamber.

6. The disinfection cap according to claim 1, characterized in that in: said outer housing having a sterile cavity in said open distal end thereof and a proximal end; The sterilization medium is directed within the sterilization cavity; The rotatable collar is rotatably coupled to the proximal end of the outer housing and to the sterilizing medium via a shaft; The visualization lumen is defined within the proximal end of the outer housing and an interior surface of the rotatable collar and is visible outside of the rotatable collar.

7. The disinfection cap according to claim 6, characterized in that The visualization chamber defines a first chamber for holding the first colored fluid and a second chamber for holding the second colored fluid, the first chamber and the second chamber being separated by a membrane within the visualization chamber, the mixer destroying the membrane when the rotatable ring rotates, and causing the corresponding different first colored fluid and second colored fluid to mix with each other and become the third color.

8. The disinfection cap according to claim 7, characterized in that wherein the membrane is oriented within the visualization chamber at an acute angle relative to an axis of rotation of the rotatable collar.

9. The disinfection cap according to claim 7, characterized in that: The first coloring fluid includes glycerin and a first coloring dye, and the second coloring fluid includes glycerin and a second coloring dye.

10. The disinfection cap according to claim 6, characterized in that: The disinfection cap also includes: an inner housing disposed within the sterilization cavity and holding the sterilization medium; and A shaft is coupled to the inner housing and the rotatable collar for rotating the inner housing.

11. The disinfection cap according to claim 10, characterized in that Wherein the shaft passes through the visualization chamber.

12. The disinfection cap according to claim 10, characterized in that: The disinfection medium includes a disinfection sponge.

13. The disinfection cap according to claim 6, characterized in that: The sterilization cap further includes a peelable tear sheet covering the open distal end of the outer shell to isolate the sterilization cavity from the surrounding environment.

14. A disinfection cap for a medical device, characterized in that: The disinfection cap comprises: an outer housing having a proximal end and a sterile cavity in an open distal end thereof; an inner housing within the sterile cavity rotatable about a first axis of rotation, the inner housing having an open distal end communicating with the open distal end of the outer housing and a proximal end; and a disinfecting medium within the inner housing; a collar rotatably coupled to the proximal end of the outer housing about a second rotational axis coaxial with the first rotational axis; a shaft coaxial with the first and second rotational axes, the shaft coupled to the proximal end of the inner housing and to the collar; a visualization chamber defined within the proximal end of the outer housing and an interior surface of the collar and visible outside the collar; a first chamber and a second chamber within the visualization chamber, the first chamber and the second chamber respectively containing corresponding different first colored fluids and second colored fluids; a membrane that is interposed between the first chamber and the second chamber and isolates the first chamber and the second chamber from each other; and and a mixer within the visualization chamber, the mixer being coupled to the interior surface of the collar, the mixer disrupting the membrane and mixing the corresponding different first colored fluid and second colored fluid with each other when the collar is rotated, wherein the rotation of the collar mixes the corresponding different first colored fluid and second colored fluid and changes them to a third color visible outside the outer housing.

15. The disinfection cap according to claim 14, characterized in that: The disinfection medium includes a disinfection sponge.

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