JP2024037783A - Sealing and cleaning device for needleless vascular access connectors - Google Patents

Abstract

To provide capping and cleansing devices for capping and cleansing needlefree connectors, particularly luer access devices such as needlefree vascular access connectors, and methods for using such devices.SOLUTION: Devices of the invention include: interconnected inner and outer housings that a user can transition between a locked or engaged position and an unlocked or disengaged position that allows the outer housing to rotate independently of the inner housing about the device's central axis; and a compressible cleansing matrix secured in the device (preferably in a well in the outer housing).SELECTED DRAWING: Figure 1A

Description

The present invention is directed to cleaning apparatus for cleaning and capping medical devices, particularly Luer access devices such as needleless valve connectors (NC), and methods for making and using such articles.

[1.First of all]
The following description contains information that may be useful in understanding the invention. Such information is
is prior art to, or is related to, the currently claimed invention;
nor does it constitute an admission that any description specifically or implicitly referred to is prior art.

[2. Background]
from potentially contaminated surfaces of medical devices, such as Luer access devices, e.g. needleless valve connectors (NC), in the medical field, particularly in the field of injecting fluids into or aspiration of fluids from patients. There remains a need to prevent the transmission of pathogens to patients. Pathogens include microorganisms such as bacteria, fungi, and viruses that, when transmitted to a patient, can cause potentially life-threatening infections. Specifically in a medical setting, the term "nosocomial infection" refers to an infection that originates or occurs in a hospital or hospital-like setting. In the United States, nosocomial infections are estimated to occur in at least 5% of all acute hospitalizations. The estimated incidence is more than 2 million cases per year, resulting in significant morbidity, mortality, and expense. In fact, nosocomial infections are estimated to more than double the risk of mortality and morbidity for any hospitalized patient, and are likely to cause approximately 100,000 deaths annually in the United States alone. Common sites for the transmission of contaminant microorganisms into a patient's bloodstream are on medical devices such as Luer access devices, vials, needleless (or needleless) valves, and injection ports on containers, tubing, and catheters. is found in The incidence of such infections in patients is increasing and infection control practitioners (ICPs)
often cite inadequate cleaning of the site as a major source of such infections.

As mentioned above, patient exposure to pathogens and infectious agents (e.g., pathogenic bacteria, viruses, fungi, etc.) in healthcare settings (e.g., hospitals, outpatient surgery centers, home health settings, etc.) is a serious concern. It is a matter. One route of exposure to such reagents is created in the epidermis, provided by the bore of a needle, cannula, or other similar device used to provide access to the patient's vasculature. It is an opening. Patients whose epidermis is damaged in this way are known to be at increased risk of developing serious bloodstream infections. In the United States alone, approximately 300,000 bloodstream infections annually result from peripheral venous catheter (PIVC) placement and use;
More than 1,000 hematologic infections have been associated with central venous catheter (CVC) use. All said: Approximately 28,000 patients die each year in the U.S. from hospital-acquired infections caused by PIVC and CVC use, and many remain critically ill but survive. It is. The costs associated with the care and treatment of patients who develop infections due to the use of PIVCs and CVCs are estimated to exceed $4 billion annually in the United States alone.

In today's hospital environment, occupational health and safety regulations designed to reduce the risk to healthcare workers from needle stick and similar injuries require that, whenever possible, needle-free medical valves (herein referred to as "needle-free connectors") ” (also known as “NC”)). Currently, more than 1 billion NCs are used annually in hospitals throughout the US needleless connectors, primarily with PIVC and CVC devices and associated IV administration and expansion sets, which are used in conjunction with only 1 May contain from 1 to 3, 4, 5, or more NCs. Figure 2A shows an example of a typical NC in use today.

The proliferation of needle-based connectors in acute care has contributed to a significant increase in the incidence of hospital-acquired infections (HAIs), particularly bloodstream infections (BSIs). To reduce the risk of infection from needleless connectors contaminated with microorganisms, standard practice today is that a nurse or other health care worker immediately before making the fluid connection to the NC, e.g. To deliver drug through a PIVC already connected to the patient, by attaching a syringe to the threaded valve portion of the NC, by vigorously rubbing the outer surface within the channel with a sterile alcohol swab or wipe. , clean the surface of the NC (
or "rubbing"). The magnitude of mortality and morbidity associated with HAIs, particularly central venous line-associated bloodstream infections (CLABSIs), and the use of PIVCs and CVCs (so-called peripheral bloodstream-associated infections (PLABSIs) and central venous line-associated bloodstream infections (PLABSIs), Given the large number of bloodstream infections that can result from each type of bloodstream infection (CLABSI), simply accessing a patient's vasculature through the needleless valve member of a PIVC or CVC inserted into a patient's blood vessel poses the risk of initiating an HAI. There is a long-recognized and still significant unmet need for articles or devices that can be used to reduce or eliminate.

Traditionally, and as described above, cleaning, cleaning, or disinfecting potentially contaminated NC surfaces has included an alcohol swabbing protocol before making the necessary connections to the site.
Alcohol swabs are typically small pads of cotton gauze soaked in isopropyl alcohol (IPA) and filled individually into foil packages to prevent IPA from evaporating from the swab before use. . When used properly, the package is opened at or near the area to be wiped. With gloved hands, a cotton swab is taken out by the nurse or other health care provider and used to rub the top and sides of the valve portion of the NC to which it will be connected. After use, the swab and foil package are discarded and the cleaned valve part of the NC is allowed to dry, usually for 20-30 seconds, just before making any connections. This "drying" period is important because as IPA dries, it breaks open the cell walls of microorganisms, thereby killing them.

Unfortunately, due to increased duties and responsibilities, reduced nursing staff, and inadequate training, alcohol swabbing (or scrubbing) is often not performed or is poorly performed. Poorly swabbed sites can carry microorganisms that, if allowed to enter a patient's body, can cause serious and potentially life-threatening infections. Also,
Without actually observing the swab, regulators will have no way of knowing whether or not the scrub was done properly, making oversight nearly impossible. In fact, reported compliance with such "hub cleaning" protocols is as low as 10%, and furthermore, "hub cleaning" is not performed without at least sufficient microscopic examination for microbial residues (e.g., biofilms). There may be no evidence that it is.

Therefore, clean the site on the medical device before use or connection with the patient, eliminate technique-related and training issues, and ensure that the site is clean before accessing the patient's vasculature. There remains a significant need for devices and techniques that provide indicators.

[3. Definition]
Before describing the present invention in detail, some terms used in the context of the present invention will be defined.
In addition to these terms, other terms are defined elsewhere herein, as appropriate.
Unless specifically defined herein, technical terms used herein have their art-recognized meanings.

As used herein, the singular forms "a,""an," and "the" include plural references unless the context clearly dictates otherwise.

The term "about" as used herein refers to a variation of about +/-10% from the stated value.
It is to be understood that such variations are always included in any given value provided herein, whether or not specifically mentioned.

A "patentable" composition, method, machine, or article of manufacture is one in which the subject matter in question satisfies all statutory requirements for patentability at the time the analysis was performed. It means that. For example, with regard to novelty, non-obviousness, etc., if a subsequent investigation reveals that one or more claims include one or more embodiments that deny novelty, non-obviousness, etc. , the claims are by definition limited to "patentable" embodiments and specifically exclude non-patentable embodiments. Additionally, the claims appended hereto should be construed to provide the broadest reasonable scope while retaining their validity.
In addition, if one or more of the statutory requirements for patentability are modified, or if the criteria for determining whether a patentability issue has been satisfied has changed since the time the patent was filed, the claim may be ( It will be interpreted in a manner that 1) maintains its validity and (2) provides the broadest interpretation under the circumstances.

"Plurality" means two or more.

The term "species", when used in the context of describing a particular compound or molecular species, refers to a chemically undefined population of molecules.

The purpose of the present invention is to address these long-standing but unmet needs. The present invention is particularly useful for luer access devices, particularly needleless connectors, and in particular for accessible surfaces of threaded valve portions of needleless connectors that may be contaminated with pathogens or other infectious reagents, and that may be contaminated with external fluid sources (e.g. , a drug-filled syringe with a male luer fitting, an IV bag, etc.) and a surface that forms part of a fluid communication pathway between the patient's bloodstream (valve surfaces, threads, etc.)
By providing a patentable single-use cleaning (disinfecting) and capping device or article that can be used to effectively and efficiently clean/disinfect and preferably sterilize exposed surfaces of , address these needs. In the context of the present invention, "cleaning" means
"Sealing" encompasses cleaning, disinfection, disinfection, and/or sterilization, and "sealing" involves the use of a device (i.e., "cap") to cover the surface or set of surfaces of the NC to the desired location of the needleless connector. Microbial flora present on such surfaces (e.g. air circulating in a hospital intensive care unit, patient skin, clothing, bedding, unclean fingers, etc.) for a longer period than is necessary to clean the surface.
means to limit or prevent exposure to the environment.

Accordingly, in one aspect, the present invention provides a cap and disinfection device for a medical device, such as a Luer access device, including a needleless valved vascular access connector (NC). Generally, such devices have an inner housing configured to allow the device to be screwed into and unscrewed from the threaded valve portion of the NC, and an inner housing that retains the inner housing, if desired. an outer housing that can be rotated independently of the inner housing to provide cleaning or disinfection action, if any;
Preferably a compressible cleaning matrix impregnated with a disinfectant, such as a 70% IPA solution. The device also preferably maintains sterility and is easily removable to prevent loss of disinfectant until used in the field to clean the NC's outer casing and after the device is assembled. Includes possible encapsulation.

The device of the invention includes an inner housing. In some preferred embodiments, the inner housing is bounded by a central internal (preferably cylindrical) bore between oppositely disposed first and second (top and bottom, respectively) openings. Consists of side walls. In many of these embodiments, the first
The (upper) opening of the compressible wash matrix resides at least partially within the matrix well or is otherwise attached to the inner surface of the outer housing, within and across the opening. The compressible cleaning matrix is sized to allow it to protrude through and into the central bore of the inner housing, such that the compressible cleaning matrix is May engage one or more external surfaces. The second (lower) opening of the inner housing is capped and/or cleaned by the threaded valve portion of the unnecessary connector for insertion into the sealing and cleaning device of the present invention. The size is such that it allows for The inner wall of the central bore of the inner housing is provided with one or more threaded engagement tabs (or threads), preferably two (or more) oppositely located (or otherwise spaced apart) preferably near the lower opening. The threaded engagement tabs are configured to engage, for example, complementary threaded areas on the outer surface of the needleless connector, such that the sealing and cleaning device is configured to engage a threaded region on the interior of the central bore of the inner housing. Through the association of a tab or thread with a complementary thread on the threaded portion of the needleless connector,
If desired, it can be screwed tightly onto (or otherwise removably connected to) the target threaded portion of the needleless connector for cleaning.

In some preferred embodiments, the outer surface of the inner housing is on the inner surface of the sidewall of the outer housing.
Enables the inner housing to be retained within the outer housing via association with one or more complementary structures (e.g., circumferential flanges (or spaced flange portions) or other suitable engagement portions) including one or more structures, such as an outer housing retention region including a circumferential flange (or spaced apart flange portions). Preferably, such configuration of complementary retainers also provides smooth, low-friction movement of the inner and outer housings relative to each other (i.e., during certain operations, e.g., during disinfection procedures of needleless connectors) , rotation). In some of these embodiments, the retainer on the inner housing may, for example, cause the user to apply sufficient force to the outer housing to compress or otherwise deform the outer housing. , allowing engagement areas on the inner surface of the outer housing to engage corresponding engagement areas on the outer surface of the inner housing, allowing the inner and outer housings to rotate in unison. (as occurs, for example, when a user attaches or removes a device from the NC), may mechanically engage an adjacent area on the inner surface of the sidewall of the outer housing. In some of these embodiments, the retainer(s) of the inner housing comprises:
as an engagement portion having a complementary area, feature, or structure on the inner surface of the sidewall of the outer housing;
It may also serve adjacent to or otherwise close to it. In other embodiments, the outer surface of the inner housing includes one or more outer housings designed to associate with one or more inner housing engaging features or regions disposed on or on the inner surface of the outer housing. It further includes a body engaging portion or region. Examples of such members include, for example, a circle of spaced teeth or tooth-like members projecting from the outer surface of the inner housing and positioned below the outer housing retention area (e.g., a circumferential flange). A circumferential band is included and these teeth (or other suitable engagement structures) are engaged by complementary structures arrayed on the inner surface of the outer housing when the housing is assembled into a functional subassembly. be able to.

In other preferred embodiments, the upper outer surface of the inner housing is such that the inner housing mechanically engages a complementary structure (e.g., a pawl or other suitable engagement feature) on the upper inner surface of the outer housing. an outer housing engagement region including one or more structures that allow the outer housing and the inner housing to The engaging portion engages, allowing the outer housing and the inner housing to rotate simultaneously. Certain preferred embodiments of the outer housing engagement structure include spaced teeth (or other suitable engagement features) arranged on or on the top surface of the preferably cylindrical sidewall of the inner housing. As will be appreciated, when such inner and outer housing engagement portions are disengaged or disengaged, the user may, for example, The outer housing can be rotated or rotated relative to the inner housing, such as during a cleaning or disinfection operation. Therefore, when a sealing and cleaning device is secured to a needleless connector, such engagement portions are not functionally associated (or mated or otherwise engaged). In this case, the user can rotate the outer housing (and the compressible cleaning matrix) relative to the inner housing and attached needleless connector. On the other hand, if the complementary members on the inner surface of the top of the outer housing and the upper surface of the top of the inner housing are engaged (in whole or even in part), e.g. In addition, when placing the device on or removing the device from the needleless connector, the inner and outer housings rotate together, e.g. when the sealing and cleaning device is attached to the NC. be installed or removed from the NC.

In some preferred embodiments, the inner housing also includes a sealing and cleaning device of the present invention;
An NC sealing member configured to provide a fluid-tight seal between the needleless connector and the needleless connector connected thereto. In some embodiments, the NC sealing member is an O-ring (or equivalent sealing body)
and preferably a channel formed in the inner surface of the wall of the inner housing proximate the second (lower) opening, typically below the threaded engagement tab(s). placed within.

The device of the invention also provides that, under certain conditions, when the device is attached to a needleless connector,
It includes an outer housing adapted or configured to retain the inner housing therein such that the outer housing can rotate relative to the inner housing (preferably about a central axis thereof). A suitable form of complementary mechanical or structural feature or member on the opposing surface or faces is used to provide retention of the inner housing within the main cavity of the outer housing so that the device can be connected to the needleless connector. installed and to allow the outer housing to be rotated relative to the inner housing when the user desires to clean the corresponding surface of the NC using the sealing and cleaning device of the present invention. Engagement and disengagement of the outer housing from the inner housing may be enabled.

In some embodiments, when a device of the present invention is attached to a needleless connector, the inner and outer housings may be rotated relative to each other by a user to rotate the outer housing relative to the inner housing to remove the device. Adopt an outer housing, neutral or rotating configuration, so that cleaning operations can be performed on the valve part of the NC where it is installed. Such disengaged, neutral, or rotated configurations may be achieved by any suitable approach, including, under certain conditions, e.g., when the outer housing is pulled up by the user relative to the inner housing. When pressed, pressed down, or squeezed, they engage each other; otherwise, the engaging parts remain disengaged, which means that when the device is secured to the NC, the outside against the inner housing including providing complementary engagement portions or structures on adjacent surfaces of the inner housing that allow rotation of the housing. Features that enable transition between the engaged and disengaged positions include springs or biasing or resilient portions or materials.
In other embodiments, when the device is attached to the needleless connector, the inner housing and the outer housing cause the engagement portion to disengage, such that the outer housing rotates independently of the inner housing. adopt an engaged configuration with respect to each other such that they rotate in unison unless the user applies sufficient force to the outer housing to allow the outer housing to rotate in unison.

The outer housing receives the inner housing, if desired, and with one or more features or members that allow the outer housing to be rotated relative to the inner housing, if desired. , including a cylindrical cavity designed to hold. The cavity is formed by a curved outer sidewall, which in some embodiments is joined to the top of the housing around its periphery, and also preferably includes a concentric central matrix well or matrix attachment area. having a compressible cleaning matrix attached thereto or therewith;
Although or otherwise related, in some embodiments some degree of eccentricity between the matrix well and the central axis of rotation of the outer housing may be desired. In some embodiments, the outer housing is formed by a sidewall that is tapered and/or has one or more steps.

In some preferred embodiments, the inner surface of the top of the outer housing has one or more internal surfaces designed to releasably engage complementary structures within the outer housing engagement region of the top of the inner housing. Inner housing engaging features or structures (eg, teeth). By engaging the inner housing engagement structure of the outer housing with that in the outer housing engagement region of the inner housing, for example, the cap and the inner housing of the cleaning device may be cleaned and/or capped. When screwed into the threaded portion of the needleless connector, the user can simultaneously rotate the outer housing and the inner housing. Once the device is releasably secured to the needleless connector via the inner housing, the inner housing engaging portion or structure of the outer housing may be compressed, e.g., by the biasing action or elasticity of the compressible irrigation matrix. The inner housing may be disengaged (or disengaged) from the engagement portion of the outer housing, thereby allowing the user to rotate the outer housing about its central axis relative to the inner housing. enable. A representative example of such an engagement structure is shown in US Patent Publication No. 2018/0304067, in which the outer casing is designed to allow contact with the surface of the needleless connector upon connection of the former to the latter. Features such as an inner housing having an opening in its top to allow a compressible cleaning matrix attached to the inner surface of the top of the inner housing to extend into the bore of the inner housing are also envisioned.

In some of these embodiments, the outer housing includes one or more vents that allow fluid and/or air from inside the device to escape when the sealing and cleaning device is secured to the needleless connector. A vent may be included, while in other embodiments no vent is provided. In embodiments with one or more vents, a membrane, filter, or other permeable or semipermeable barrier is used to permit unidirectional or bidirectional flow of air, gas, or vapor through the vents. However, microorganisms (eg, bacteria, fungi, viruses, etc.) can be prevented from migrating into the sealing and cleaning device of the present invention.

In certain preferred embodiments, the outer surface of the outer housing of the sealing and cleaning device according to the invention comprises:
including one or more grip-enhancing structures (eg, multiple vertical ridges) or coatings. Such a grip-enhancing structure or coating makes it easier for the user to grasp the seal and housing of the cleaning device between the fingers, and this is useful not only during insertion and removal of the needleless connector from the cap cleaning device. , which may also be useful during the cleaning process, in which the user rotates the outer housing relative to the inner housing to clean the surface of the inserted needleless connector with the device's compressible cleaning matrix. Rub, thereby cleanse or wash.

In some embodiments, the devices of the present invention include one or more members or features arranged on opposite surfaces of the inner and outer housings, so that the user can easily understand when the device is attached. ing
It can be sensed that the outer housing is rotating relative to the inner housing to provide a cleaning action on the valve surface of the NC. Such sensory feedback may include one or more of auditory, tactile, and/or visual stimuli generated from the device by rotation of the outer housing relative to the inner housing.

In the device of the invention, the inner and outer housings are manufactured separately by any suitable process, e.g., 3D printing, injection molding, etc., and then one or more complementary retainers on each housing A section, mechanism, or structure assembles the inner housing into a two-part subassembly held within the main cavity of the outer housing. The inner and outer housings may also be configured to allow the inner and outer housings to rotate together or to allow the outer housing to rotate independently of the inner housing. includes complementary mechanical or structural engagement features, features, or structures on one or more interface surfaces that can be engaged and disengaged. In this way, the inner and outer housings can be associated so that they can rotate in unison, allowing the user to place the device on the threaded valve portion of the NC if desired. or to remove (unscrew) the device from the threaded valve portion of the NC, while simultaneously allowing the user to rotate the outer housing relative to the inner housing. and thereby the compressible cleaning matrix is attached to the NC
allows the area of the threaded valve part to be effectively cleaned or cleaned. In certain preferred embodiments, the inner and outer housings have complementary mechanical or structural containment seals that enable the formation of a seal between adjacent surfaces of the inner and outer housings. further comprising a section, feature, or structure on the one or more interface surfaces, the seal preferably being substantially fluid-tight, but not capable of forming the inner housing during a cleaning procedure or performance of a process by a user. does not substantially impede or inhibit rotation of the outer housing relative to the outer housing. In some embodiments, the inner housing can also include a seal that interacts with the needleless connector to form an additional or alternative seal.

The sealing and cleaning device of the present invention also includes a compressible cleaning matrix disposed therein. In most embodiments, the compressible cleaning matrix is placed within the outer housing, such as in a matrix well, but the compressible cleaning matrix is rotated in conjunction with the rotation of the outer housing so that the compressible cleaning matrix becomes compressible. Any suitable retention configuration that allows the cleaning matrix to be used to provide the ability to scrub or otherwise clean, clean, or disinfect the surface of the valve area of the needleless connector. can be adopted. As will be appreciated, the compressible cleaning matrix is placed in contact with one or more external surfaces of the NC connected to the sealing and cleaning device. A compressible cleaning matrix, such as open cell or felt foam, is preferably held in the matrix well by one or more matrix retainers, which are used during the procedure for disinfecting or cleaning needleless connectors. In addition to transmitting rotational forces from the outer housing to the compressible cleaning matrix, such as occurs in the matrix wells, the compressible cleaning matrix assists in retaining the compressible cleaning matrix in the matrix wells. As will be appreciated, during such rotation (of the outer housing and compressible cleaning matrix), the compressible cleaning matrix also is rotated relative to the inner housing. A compressible cleaning matrix attached to or otherwise associated with the outer housing is axially compressed (i.e., compresses the matrix well of the outer housing) upon insertion of the needleless connector within such a sealing and cleaning device. (compression along the central axis).

The needle-free connector surface that is cleaned is free of microorganisms that form biofilms (i.e., a matrix of microorganisms and microorganisms, typically bacteria and/or fungi, that adhere to the surface and carry out specific biochemical processes). The compressible cleaning matrix also preferably has sufficient mechanical integrity when compressed and rolled, since it can become contaminated with extracellular material attached to the surface, allowing for example The surface of the needleless connector is removed by rotating the inner housing of the sealing and cleaning device and the outer housing (to which the compressible cleaning matrix is attached) relative to the needleless connector to which the inner housing is releasably attached. Remove any biofilm that may be present on the surface of the needle-free connector, such as by rotating, twisting, or otherwise moving any biofilm that may be present on the needle-free connector. Allows to destroy biofilms. The friction created between the compressed cleaning matrix and the surface of the needle-free connector disrupts the biofilm, thereby cleaning and preferably sterilizing the needle-free connector. After such cleaning operations, leaving the sealing and cleaning device secured (i.e., capping) the needleless connector will prevent biofilm regrowth and
Microbial recolonization of the cleaned surface (which remains in contact with the compressible cleaning matrix) is limited and preferably prevented.

In preferred embodiments, the compressible cleaning matrix includes one or more cleaning reagent species dispersed therein, preferably at the time the device is manufactured, but in some embodiments,
A wash reagent may be dispersed into the matrix just before the matrix contacts the needleless connector. In the latter type of embodiment, the cleaning reagent is preferably sealed and contained within the housing of the cleaning device in a reservoir configured to burst immediately prior to performance of the cleaning operation. In some embodiments, the sealing and cleaning device of the present invention includes a valve or opening that allows liquid in the cleaning reagent to evaporate.

In some preferred embodiments, the compressible cleaning matrix includes two or more components. In some such embodiments, one component of the matrix is attached to the inner surface of the outer housing and another component is fixed to the inner surface of the wall forming the inner housing, preferably with needles None between the protruding threaded areas adapted to engage complementary threads on the connector. If present, a compressible cleaning matrix component secured to the inner surface of the inner housing wall is preferably configured to compress radially in conjunction with the needleless connector to be capped and cleaned. .

In a preferred embodiment, the sealing and cleaning device of the present invention includes a removable lid or closure attached to the outer housing to seal the device, thus allowing the interior of the inner and outer housings to be sealed. Separate spaces and structures from the external environment. Such a lid or closure is
Typically, a removable (preferably peelable) The interior of the device, including the internal housing and compressible cleaning matrix, is prevented from being exposed to the environment until the lid or closure is removed. In preferred embodiments, such cleaning substantially destroys any microbial contamination, such as microbial biofilm or other microbial contamination, that may be present on the surfaces contacted by the compressible cleaning matrix. If desired, the sealing and cleaning device is placed in place (typically after cleaning the needleless connector attached to it) to cap the needleless connector until it is accessed further. can be left behind, thereby minimizing exposure of the capped external surface of the NC to potential pathogen contamination (and biofilm formation) from the surrounding environment.
The lid or closure is typically installed during manufacture of the sealing and cleaning device of the present invention. In embodiments where the cap and cleaning device are sterilized during manufacturing (eg, by irradiation, exposure to ethylene oxide, etc.), the lid or closure is preferably applied prior to packaging and sterilization.

In some preferred embodiments, the devices of the invention are individually sealed, while in other embodiments, 2 to 20 or more devices are sealed onto a single piece of lid or sealing stock, and then
They may be separated into individual sealed products or maintained in a band form, which is a band form with multiple devices all sealed in a single band. For example, it is a convenient format for use in a medical setting that can be hung from an IV pole at a patient's bedside. After sealing and packaging, devices of the invention may be sterilized using any suitable sterilization method compatible with the materials used to manufacture the particular device of the invention (e.g., gamma or electron beam irradiation, treatment with ethylene oxide, etc.). ) is used to sterilize.

Another aspect of the invention relates to a method of cleaning and/or sealing a needleless connector using a sealing and cleaning apparatus according to the invention. Such methods typically include disengaging the engagement portions of the outer housing and inner housing housings after being connected to the needleless connector, such that the user and allowing the outer housing to rotate or rotate relative to the needleless connector to which the device of the invention is fixed. Such disengagement does not compromise the contact between the compressible cleaning matrix of the device and the relevant surface of the needleless connector. The spinning or rotation of the outer housing relative to the inner housing and the associated surfaces of the needleless connector allows these surfaces to be rubbed, thereby cleaning them. Preferably, such a cleaning method provides for the destruction of any biofilm present on the surface of the needleless connector associated with the sealing and cleaning device. Also, in embodiments where the compressible cleaning cleaning matrix contains one or more antimicrobial reagents, microorganisms and pathogens present in such biofilms and/or on such surfaces, preferably , or rendered non-viable.

The features and advantages of the invention will be apparent from the following detailed description and appended claims.

These and other aspects are described in detail below with reference to the following figures. It is to be understood that, unless otherwise noted, the drawings are not to scale, and are not to scale, and are merely intended to facilitate an understanding of the invention. In the drawings, like numbers in two or more drawings represent similar elements.

Some drawings ((a)-( g)). An exploded view (a) of an exemplary sealing and cleaning device of the present invention and a needleless connector, and several cross-sectional views ((b)-(d) of a sealed exemplary sealing and cleaning device of the present invention ), as well as such sealing and cleaning devices (c) and (d)) for sealing needleless connectors. 6 shows six different views of a representative sealing and cleaning device of the present invention. Figures (a) to (c) show the device in a rest position, where the cap and the resilient inner body are arranged so that the cap, and therefore the associated compressible cleaning matrix, is against the resilient inner body of the device. Rotatably engaged. Figures (d)-(f) show the cap and elastic inner body in a movable relationship such that the cap (and its associated compressible cleaning matrix) can be rotated relative to the elastic inner body of the device. The same representative device is shown. Figure 3 shows a view of the cap portion of a representative sealing and cleaning device of the present invention. Figure (a) shows a top view of the cap portion. Figure (b) shows a side view of the cap portion. Figure (c) shows a bottom view of the cap portion. Figure (d) shows a cross-sectional view of the cap part. Representative measurements for this particular embodiment are shown in figures (b) and (d). 7 shows seven different views ((a)-(g)) of a resilient inner body portion of a representative sealing and cleaning device of the present invention; FIG. Representative measurements of this particular embodiment are shown in several figures. Five different views ((a)-(e)) are shown, three of which show the compressible cleaning matrix portion of a representative sealing and cleaning device of the present invention. Figures (a)-(c) show top, side, and bottom views of this particular compressible cleaning matrix. Figures (d) and (e) show bottom and side views of the sealing portion of a representative sealing and cleaning device of the present invention. 5 shows five different views of another exemplary sealing and cleaning device of the present invention. FIG. 7A is an exploded perspective view of the device (outer housing, compressible cleaning matrix, and inner housing) and the NC to which the device is connected (see FIGS. 7B, 7E). Figure 7B shows a perspective view of the assembled device depicted in Figure 7A secured to the threaded region of the valve portion of the NC depicted in Figure 7A. Figure 7C shows an exploded cross-sectional view of the component depicted in Figure 7A, while in Figure 7D a cross-sectional view shows the functional component ready for installation in the threaded area of the valve portion of the NC depicted in Figure 7A. Figure 3 shows the components of the device of the invention (outer housing, compressible cleaning matrix, and inner housing) assembled into a sealing and cleaning device. FIG. 7E is a cross-sectional view showing the sealing and cleaning device of the present invention threaded onto the NC resulting in compression of the compressible matrix against the valve surface of the NC. Figure 5 shows five different views of another exemplary sealing and cleaning device of the present invention. FIG. 8A shows an exploded perspective view of the device (outer housing, compressible cleaning matrix, and inner housing) and NC to which the device is connected (see FIGS. 8B, 8E). Figure 8B shows a perspective view of the assembled device depicted in Figure 8A secured to the threaded region of the valve portion of the NC depicted in Figure 8A. Figure 8C shows an exploded cross-sectional view of the component depicted in Figure 8A, while in Figure 8D the cross-sectional view shows the functional component ready for installation in the threaded area of the valve portion of the NC depicted in Figure 8A. Figure 3 shows the components of the device of the invention (outer housing, compressible cleaning matrix, and inner housing) assembled into a sealing and cleaning device. FIG. 8E is a cross-sectional view showing the sealing and cleaning device of the present invention threaded onto the NC resulting in compression of the compressible matrix against the valve surface of the NC. 9A shows a perspective view of the device secured to the threaded region of the valve portion of the NC; FIG. 9B and 9C respectively show exploded cross-sectional views of the device/NC assembly shown in FIG. 9A. The difference is that the view shown in FIG. 9C is slightly rotated about the central axis of the device/NC assembly compared to the view shown in FIG. 9B. FIG. 9D shows an exploded perspective view of the device depicted in FIGS. 9A-9C (outer housing, compressible cleaning matrix, and inner housing). FIG. 9E shows a side cross-sectional and bottom view of the device depicted in FIGS. 9A-9D. Figure 3 shows three different cutaway views of another exemplary sealing and cleaning device of the present invention. figure. 10B and 10C show the device secured to the threaded region of the valve part of the NC, and FIG. 10A shows the device detached from the NC. FIG. 10B shows the outer housing of the device in a neutral position (the engaging portions of the inner and outer housings are not engaged), from which the user can The outer housing (and compressible wash matrix) can be rotated relative to the fixed NC. As will be appreciated, the compressible matrix will push the outer housing up against the inner housing in the absence of a sufficient counteracting downward force, allowing the user to push the outer housing ( and compressible cleaning matrix) and can act as a spring to push up the outer housing if desired. Without such rotation, while connected to the NC, the sealing and cleaning device of the present invention acts as a cap to protect the threaded valve area of the NC from environmental contamination, including microbial contamination. FIG. 10C depicts the device when the engagement portions of the inner and outer housings are engaged, allowing the device to be screwed into or unscrewed from the NC.

The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features and advantages will be apparent from the description and drawings, and from the claims.

[Detailed explanation]
In the following detailed description, reference is made to the accompanying drawings (FIGS. 1-10), which form a part thereof. In the figures, like symbols typically identify similar components, unless the context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized and other changes may be made without departing from the spirit or scope of the subject matter presented herein.

The present invention relates to exposed surfaces of needleless connectors, particularly needleless pharmaceutical valves, etc., which sometimes become part of a fluid communication pathway for introducing fluids (e.g., IV fluids, blood, plasma, drugs, etc.) into a patient. Effectively and efficiently clean, disinfect, and preferably sterilize exposed surfaces of the Luer access device, as these surfaces are at risk of contamination with pathogens and infectious reagents such as bacteria, fungi, and viruses. and a patentable single-use cap and cleaning device that can be used for. "Single use" (or "single purpose") refers to an article or device suitable for only one use or purpose, as distinguished from "dual" or "multiple" use or purpose devices, and therefore , in the context of the present invention, a "single use" sealing and cleaning device is one that is useful, for example, for cleaning needleless medical valves. After the cleaning operation, to prevent recontamination of the cleaned surfaces of the connector, as would occur if the sealing and cleaning device of the invention were removed immediately after "cleaning" the connector without making a fluid connection. If desired, the device can be left in place on the needleless connector until subsequent fluid connections are made. After removal, the device of the invention is preferably discarded. However, before removal, the sealing and cleaning device can be used again to clean the capped surface of the needleless connector.

Generally, the sealing and cleaning device of the present invention has an inner housing configured to allow the device to be screwed onto and unscrewed from the threaded valve portion of the NC, and an inner housing that retains the inner housing if desired. , comprising an outer housing that can be rotated independently of the inner housing to provide a cleaning or disinfection action, and a compressible cleaning matrix preferably impregnated with a disinfectant, such as a 70% IPA solution. . The device also preferably maintains sterility and prevents loss of disinfectant until after the device is assembled and used in the field to clean the outer casing and the NC.
Contains an easily removable seal.

Generally, such devices have an inner housing configured to allow the device to be screwed into and unscrewed from the threaded valve portion of the NC, and an inner housing that retains the inner housing, if desired. an outer housing that can be rotated independently of the inner housing to provide cleaning or disinfection action, if any, and a compressible cleaning matrix preferably impregnated with a disinfectant, such as a 70% IPA solution. including. The device is also preferably maintained in a sterile condition and after the device is assembled.
The NC contains an easily removable seal to prevent loss of disinfectant until used in the field for outer casing and cleaning.

The device of the invention includes an inner housing. In some preferred embodiments, the inner housing is bounded by a central internal (preferably cylindrical) bore between oppositely disposed first and second (top and bottom, respectively) openings. Consists of side walls. In many of these embodiments, the first
The (upper) opening of the compressible wash matrix resides at least partially within the matrix well or is otherwise attached to the inner surface of the outer housing, within the opening, and across the opening. The compressible cleaning matrix is sized to allow it to protrude through and into the central bore of the inner housing, so that the compressible cleaning matrix can be removed from the needleless connector when the sealing and cleaning device is secured to the connector. May engage one or more external surfaces. The second (lower) opening of the inner housing is inserted into the sealing and cleaning device of the present invention so that the threaded valve portion of the unnecessary connector is sealed and/or cleaned. It is of such a size that it allows The inner wall of the central bore of the inner housing is provided with one or more threaded engagement tabs (or threads), preferably two (or more) oppositely located (or otherwise spaced apart) preferably near the lower opening. The threaded engagement tabs may be e.g.
The sealing and cleaning device is configured to engage a complementary threaded area on the exterior surface of the needleless connector, such that the sealing and cleaning device connects the threaded tab or thread on the interior of the central bore of the inner housing with the threaded tab or thread on the interior of the central bore of the inner housing. sealing and, if desired, through association with complementary threads on the threaded portion of the
For cleaning, it can be screwed tightly onto (or otherwise removably connected to) the target threaded portion of the needleless connector.

In some preferred embodiments, the outer surface of the inner housing includes one or more complementary structures on the inner surface of the sidewalls of the outer housing, such as circumferential flanges (or spaced flange portions) or other suitable one or more structures, such as a circumferential flange (or spaced apart flange portions), that enable the inner housing to be retained within the outer housing through association with a circumferential flange (or spaced apart flange portions); Includes housing holding area. Preferably, such configuration of complementary retainers also provides smooth, low-friction movement of the inner and outer housings relative to each other (i.e., during certain operations, e.g., during disinfection procedures of needleless connectors) , rotation). In some of these embodiments, the retainer on the inner housing may, for example, cause the user to apply sufficient force to the outer housing to compress or otherwise deform the outer housing. , allowing engagement areas on the inner surface of the outer housing to engage corresponding engagement areas on the outer surface of the inner housing, allowing the inner and outer housings to rotate in unison. (as occurs, for example, when a user attaches or removes a device from the NC), may mechanically engage an adjacent area on the inner surface of the sidewall of the outer housing. In some of these embodiments, the retaining feature(s) of the inner housing is adjacent thereto as an engaging feature with complementary areas, features, or structures on the inner surface of the sidewall of the outer housing. , or otherwise may serve in close proximity to it. In other embodiments, the outer surface of the inner housing includes one or more outer housings designed to associate with one or more inner housing engaging features or regions disposed on or on the inner surface of the outer housing. It further includes a body engaging portion or region. Examples of such members include, for example, a circle of spaced teeth or tooth-like members projecting from the outer surface of the inner housing and positioned below the outer housing retention area (e.g., a circumferential flange). A circumferential band is included and these teeth (or other suitable engagement structures) are engaged by complementary structures arrayed on the inner surface of the outer housing when the housing is assembled into a functional subassembly. be able to.

In other preferred embodiments, the upper outer surface of the inner housing is such that the inner housing mechanically engages a complementary structure (e.g., a pawl or other suitable engagement feature) on the upper inner surface of the outer housing. an outer housing engagement region including one or more structures that allow the outer housing and the inner housing to The engaging portion engages, allowing the outer housing and the inner housing to rotate simultaneously. Certain preferred embodiments of the outer housing engagement structure include spaced teeth (or other suitable engagement features) arranged on or on the top surface of the preferably cylindrical sidewall of the inner housing. As will be appreciated, when such inner and outer housing engagement portions are disengaged or disengaged, the user may, for example, The outer housing can be rotated or rotated relative to the inner housing, such as during a cleaning or disinfection operation. Therefore, when a sealing and cleaning device is secured to a needleless connector, such engagement portions are not functionally associated (or mated or otherwise engaged). In this case, the user can rotate the outer housing (and the compressible cleaning matrix) relative to the inner housing and connected needleless connector. On the other hand, if the complementary members on the inner surface of the top of the outer housing and the upper surface of the top of the inner housing are engaged (in whole or even in part), e.g. In addition, when placing the device on or removing the device from the needleless connector, the inner and outer housings rotate together, e.g. when the sealing and cleaning device is attached to the NC. be installed or removed from the NC.

In some preferred embodiments, the inner housing also includes a sealing and cleaning device of the present invention;
An NC sealing member configured to provide a fluid-tight seal between the needleless connector and the needleless connector connected thereto. In some embodiments, the NC sealing member is an O-ring (or equivalent sealing body)
and preferably a channel formed in the inner surface of the wall of the inner housing proximate the second (lower) opening, typically below the threaded engagement tab(s). placed within.

The device of the invention also provides that, under certain conditions, when the device is attached to a needleless connector,
It includes an outer housing adapted or configured to retain the inner housing therein such that the outer housing can rotate relative to the inner housing (preferably about a central axis thereof). A suitable form of complementary mechanical or structural feature or member on the opposing surface or faces is used to provide retention of the inner housing within the main cavity of the outer housing so that the device can be connected to the needleless connector. installed and to allow the outer housing to be rotated relative to the inner housing when the user desires to clean the corresponding surface of the NC using the sealing and cleaning device of the present invention. Engagement and disengagement of the outer housing from the inner housing may be enabled.

In some embodiments, when a device of the present invention is attached to a needleless connector, the inner and outer housings may be rotated relative to each other by a user to rotate the outer housing relative to the inner housing to remove the device. Adopt an outer housing, neutral or rotating configuration, so that cleaning operations can be performed on the valve part of the NC where it is installed. Such disengaged, neutral, or rotated configurations may be achieved by any suitable approach, including, under certain conditions, e.g., when the outer housing is pulled up by the user relative to the inner housing. When pressed, pressed down, or squeezed, they engage each other; otherwise, the engaging parts remain disengaged, which means that when the device is fixed to the NC, the outside against the inner housing including providing complementary engagement features or structures on adjacent surfaces of the inner housing that allow rotation of the housing. Features that enable transition between the engaged and disengaged positions include springs or biasing or resilient elements or materials. In other embodiments, when the device is attached to the needleless connector, the inner housing and the outer housing cause the engagement portion to disengage, such that the outer housing rotates independently of the inner housing. rotate in unison unless the user applies sufficient force to the outer housing to allow
They adopt an engaging configuration with respect to each other.

The outer housing receives the inner housing, if desired, and with one or more features or elements that allow the outer housing to be rotated relative to the inner housing, if desired. , including a cylindrical cavity designed to hold. The cavity is formed by a curved outer sidewall, which in some embodiments is joined to the top of the housing around its periphery, and also preferably includes a concentric central matrix well or matrix attachment area. having a compressible cleaning matrix attached thereto or therewith;
Although otherwise related, in some embodiments some degree of eccentricity between the matrix well and the central axis of rotation of the outer housing may be desired. In some embodiments, the outer housing is formed by a sidewall that is tapered and/or has one or more steps.

In some preferred embodiments, the inner surface of the top of the outer housing has one or more internal surfaces designed to releasably engage complementary structures within the outer housing engagement region of the top of the inner housing. Inner housing engaging features or structures (eg, teeth). By engaging the inner housing engagement structure of the outer housing with that in the outer housing engagement region of the inner housing, for example, the cap and the inner housing of the cleaning device may be cleaned and/or capped. When screwed into the threaded portion of the needleless connector, the user can simultaneously rotate the outer housing and the inner housing. Once the device is releasably secured to the needleless connector via the inner housing, the inner housing engaging portion or structure of the outer housing may be compressed, e.g., by the biasing action or elasticity of the compressible irrigation matrix. The inner housing may be disengaged (or disengaged) from the outer housing engagement portion, thereby allowing the user to rotate the outer housing about its central axis relative to the inner housing. enable. A representative example of such an engagement structure is shown in US Patent Publication No. 2018/0304067, in which the outer casing is designed to allow contact with the surface of the needleless connector upon connection of the former to the latter. Features such as an inner housing having an opening in its top to allow a compressible cleaning matrix attached to the inner surface of the top of the inner housing to extend into the bore of the inner housing are also envisioned.

In some of these embodiments, the outer housing includes one or more vents that allow fluid and/or air from inside the device to escape when the sealing and cleaning device is secured to the needleless connector. A vent may be included, while in other embodiments no vent is provided. In embodiments with one or more vents, a membrane, filter, or other permeable or semipermeable barrier is used to permit unidirectional or bidirectional flow of air, gas, or vapor through the vents. However, microorganisms (eg, bacteria, fungi, viruses, etc.) can be prevented from migrating into the sealing and cleaning device of the present invention.

In certain preferred embodiments, the outer surface of the outer housing of the sealing and cleaning device according to the invention comprises:
Includes one or more grip-enhancing structures (eg, multiple vertical ridges) or coatings. Such grip-enhancing structures or coatings make it easier for the user to grasp the seal and housing of the cleaning device between their fingers, and this is useful not only during insertion and removal of the needleless connector from the cap cleaning device. , which may also be useful during the cleaning process, in which the user rotates the outer housing relative to the inner housing to clean the surface of the inserted needleless connector with the device's compressible cleaning matrix. Rub, thereby cleanse or wash.

In some embodiments, devices of the present invention include one or more elements or features arranged on opposing surfaces of the inner and outer housings, which allow a user to view the device when it is attached. ing
It can be sensed that the outer housing is rotating relative to the inner housing to provide a cleaning action on the valve surface of the NC. Such sensory feedback may include one or more of auditory, tactile, and/or visual stimuli generated from the device by rotation of the outer housing relative to the inner housing.

In some of these embodiments, the device of the invention comprises a resilient inner body that is disposed within the cap and rotated or can be rotated relative to the cap when the cap and cleaning device are secured to the needleless connector; a compressible matrix portion containing one or more antimicrobial reagents and having a structure that allows the capped surface of the needleless connector to be cleaned. More specifically, the elastic inner body has oppositely arranged first and second (respectively, or upper and lower)
It has walls defining a central internal (preferably cylindrical) bore extending between the openings. The inner wall of the central bore near the second (lower) opening has two threaded engagement tabs located opposite each other.
(or a plurality of threads). The threaded engagement tab, for example, is configured to engage a complementary threaded region on the outer surface of the needleless medical valve. This allows the cap and cleaning device to be screwed tightly onto the targeted threaded portion of the needleless connector for cleaning and to be capped onto that portion of the needleless connector if desired. The outer surface of the resilient inner body includes one or more structures that allow it to be mechanically engaged and disengaged with complementary structures disposed on the inner surface of the cap.

In many embodiments, the outer surface of the resilient inner body includes spaced convexities (e.g.,
a cap-engaging region including one or more structures such as teeth); A preferred embodiment of the cap engagement structure includes alternating teeth and grooves (or channels) arranged around the circumference of the resilient inner body, the teeth and grooves being disposed on the inner surface of the outer wall of the cap. Complementary with one or more spaced apart engagement structures (eg, teeth). In other embodiments, the cap engagement region of the resilient inner body is configured to engage one or more complementary engagement structures (e.g., teeth) disposed on or on the exterior surface of the matrix well wall. placed on the inner surface. As will be appreciated, in configurations that include teeth and channels, the "teeth" may be raised protrusions, and the "channels" may be spaces or gaps between the raised protrusions.

The resilient inner body also includes a compressible region. In many preferred embodiments, the threaded engagement tab(s) and cap engagement area are positioned above the cap engagement area. The compressible region is optionally capable of compressing the elastic inner body to bring the first and second openings closer together to enable disengagement of the engagement structure of the cap and the elastic inner body. It can be a structure. In a preferred embodiment, the compressible region is a torsion spring, which in certain particularly preferred embodiments is made of plastic or other sufficiently flexible or A molded torsion spring made from a resilient material.

In some embodiments, the resilient inner body is made from two or more parts that are then assembled to form the completed inner body. For example, the resilient inner body can be formed as two or more separate parts that are assembled one above the other during manufacture of the sealing and cleaning device of the present invention. For example, in embodiments where the resilient inner body is made of two parts, the upper part preferably includes a compressible region (e.g., a threaded spring formed during injection molding of the upper part), while the lower part comprises a cap. including an engagement region and threaded engagement tab(s). In contrast, a typical three-part embodiment of a resilient inner body includes an upper section containing a first (upper) opening and a compressible region, an intermediate section containing a cap engagement region, and a threaded inner body. Engagement tab (
one or more) and a lower section comprising a second (lower) opening. In an alternative three-part embodiment, the upper part includes a first (upper) opening and a cap engagement region, the middle part includes a compressible region, and the lower part includes a threaded engagement tab (single or plural) and
Including 2 (lower) openings. As will be appreciated, the present invention encompasses all possible combinations of components having a cap-engaging region, a compressible region, and a region that engages the threaded portion of the threaded portion of the needleless connector, such that: The cap and inner body can rotate together about their central axis when the final combination is compressed and the corresponding structures on the cap and inner body are engaged; When the corresponding structure of the compressible region is disengaged by compression of the compressible region, the user can rotate the cap about its central axis or independently of the resilient inner body (i.e., the resilient inner body (the cap spins while not engaged), demonstrating that the resilient inner body can be rotated out of engagement or independently.

In embodiments of the invention in which the resilient inner body is made of two or more parts, these parts, once assembled, preferably include, for example, a sealing and cleaning device of which they are a part, a needleless connector, For example, they are mechanically connected so that when screwed into the threaded part of the needleless connector, they also move at the same time. Any suitable mechanical lock and corresponding set of mechanical structures can be used to link such parts together.

In some preferred embodiments, the inner housing or resilient inner body also includes a sealing member configured to provide a fluid-tight seal between the sealing and cleaning device of the present invention and the NC connected thereto. (i.e., a sealed body). The seal preferably has a threaded engagement tab (
(singular or plural).

Each device of the invention also includes an outer housing or cap operably associated with an inner housing, such as a resilient inner body. The cap typically has an outer cavity formed by a curved outer wall joined to the top, preferably around the periphery of the top, and a preferably concentric central matrix well extending into the outer cavity from the inner surface of the top. including. The walls forming the matrix well are spaced apart from the outer wall of the cap and form a resilient member housing accessible through the opening created by the gap between the cap wall and the matrix well wall. In many preferred embodiments, the inner surface of the outer wall of the cap has one or more engaging or locking structures (e.g. , teeth) (i.e., corresponding structures can be engaged and disengaged as desired). In other embodiments, a cap engagement or locking structure is disposed on the outer surface of the matrix well wall, and the locking structure is releasably engaged with a complementary structure in the cap engagement region on the inner wall of the resilient inner body. designed to engage. By engaging the cap engagement or locking structure with that in the cap engagement region of the resilient inner body, the user can, for example, attach the cap and cleaning cap to the threaded needleless connector to be cleaned and/or capped. When screwed into the part, the cap and the elastic inner body can be rotated simultaneously. Once the device is removably secured to the needleless connector, the locking structure of the cap can be disengaged from those within the cap engagement area of the resilient inner body, thereby allowing the user to The cap can be rotated about its central axis. In some embodiments, the cap may include one or more vents that allow fluid and/or air from inside the device to escape when the cap and cleaning device are secured to the needleless connector. However, in other embodiments, no vents are provided.

The sealing and cleaning device of the present invention also includes a compressible cleaning matrix within the matrix well of the outer housing. The compressible cleaning matrix may be, for example, an open cell foam. The cleaning matrix is preferably fixed to the inner surface of the outer housing so as to limit or limit its rotation independently of the outer housing during rotation of the outer housing. The compressible cleaning matrix is configured to contact and clean one or more surfaces of the needleless connector that contact the matrix upon association of the needleless connector with the sealing and cleaning apparatus of the present invention. A compressible cleaning matrix attached to or otherwise associated with the outer housing comprises:
When the needleless connector is inserted into the sealing and cleaning device, it can be compressed axially (ie, compressed along the central axis of the matrix well of the outer housing).

The needleless connector surface that is cleaned is free of biofilms (i.e., microorganisms attached to the surface that allow microorganisms, typically bacteria and/or fungi, to adhere to the surface and carry out specific biochemical processes. The compressible cleaning matrix preferably has sufficient mechanical integrity when compressed so that the materials contacted by the cleaning matrix can become contaminated with microorganisms forming Allowing its use to destroy any biofilm that may be present on the surface of the needle connector. Disruption of the biofilm can be achieved, for example, by using an outer housing (e.g., a compressible cleaning matrix) as opposed to an inner housing (e.g., a resilient inner body) of a sealing and cleaning device and a needleless connector to which the inner housing is removably attached. The compressed irrigation matrix is then rotated relative to the needleless connector (e.g., a needleless medical valve) by rotating the attached or otherwise associated or retained , by twisting or otherwise moving. The friction created between the compressed cleaning matrix and the surface of the needle-free connector disrupts the biofilm, thereby cleaning and preferably sterilizing the needle-free connector. After such cleaning, leaving the sealing and cleaning device secured to (i.e., sealing) the needleless connector may result in biofilm regrowth of the needleless connector and/or the cleaned surface (compressible cleaning matrix). microbial recolonization (remaining in contact with) is limited and preferably prevented.

In preferred embodiments, the compressible cleaning matrix includes one or more cleaning reagent species dispersed therein, preferably at the time the device is manufactured, but in some embodiments,
A wash reagent may be dispersed into the matrix just before the matrix contacts the needleless connector. In the latter type of embodiment, the cleaning reagent is preferably contained within the body of the seal and cleaning device in a reservoir configured to rupture upon mating of the needleless connector for cleaning. Such a reservoir may be placed between the matrix and the needleless connector, or more preferably between the rotatable cap and the compressible irrigation matrix. Preferred cleaning reagents include antimicrobial reagents such as isopropyl alcohol, chlorhexidine, and silver ions. In some embodiments, the sealing and cleaning apparatus of the present invention comprises:
Contains a valve or opening to allow liquid in the wash reagent to evaporate.

In some preferred embodiments, the compressible cleaning matrix is comprised of two or more components. In some such embodiments, a portion of the matrix is attached to the inner surface of the outer housing and another portion is secured to the inner surface of the wall forming the matrix well. If present, the portion of the compressible cleaning matrix secured to the inner surface of the matrix well wall is preferably configured to radially compress in conjunction with the needleless connector that is capped and cleaned. If the cleaning matrix is composed of two or more components, the matrix components can be made from the same different materials.

As mentioned above, the central matrix well is adapted to receive a compressible wash matrix. The surface of the central matrix that is in sufficient contact with the matrix is preferably disengaged such that, in particular, the cap's engagement structure and resilient inner body allow rotation of the cap during the needleless connector cleaning procedure. and one or more retention structures for retaining the compressible cleaning matrix so as to couple its rotation or movement to the rotation or movement of the cap when the cleaning matrix is compressed. Such retention structures include ridges and other protrusions from the surface of the central matrix that are in substantial contact with the compressible cleaning matrix. An adhesive can also be used to adhere the portion of the compressible wash matrix to the desired location within the matrix well.

In various embodiments, the exterior surface of the outer housing of a sealing and cleaning device according to the present invention includes one or more grip-enhancing structures or coatings, such as a plurality of vertical ridges. Such grip-enhancing structures or coatings make it easier for the user to grasp the body of the sealing and cleaning device between their fingers, and this is useful not only during insertion and removal of the needleless connector from the cap cleaning device. , may also be useful during the cleaning process where the user rotates the outer housing relative to the inner housing to rub the surface of the inserted needleless connector with a compressible cleaning matrix, thereby cleaning/cleaning. .

The inner and outer housings may be made from any suitable material or combination of different materials. Plastics are particularly preferred. The material used to manufacture the outer casing is
The material may be the same or different from that used to manufacture the inner housing.

The outer housing and its various components are preferably manufactured during manufacturing (e.g., by injection molding).
Formed as a single integral unit. The inner and outer housings can be manufactured by any suitable process including extrusion, injection molding, and additive manufacturing (eg, 3D printing). After manufacturing, the inner housing is inserted into the outer housing to form the sealing and cleaning device of the present invention. the inner and outer housings as functional subassemblies capable of transitioning between engaged and disengaged configurations to provide single or independent rotation of the outer housing relative to the inner housing; Any suitable retention structure or structures that provide for movement, ie rotation, of the outer housing relative to the inner housing may be used to secure the outer housing together. Such structures include attachment mechanisms such as "snap-fit" mechanisms in which the interacting parts are sufficiently flexible and preferably have tapered surfaces to facilitate assembly.

A compressible cleaning matrix can be placed within the matrix well after the inner and outer housings are operably associated. In a preferred embodiment, a suitable adhesive is used to attach the compressible cleaning matrix, or, if the matrix includes more than one part, its various parts, to one of the matrix wells of the outer housing. Glue firmly to the inner surface of the above. In some embodiments, the surfaces of the matrix wells that contact the compressible matrix include structures that help securely retain the matrix within the wells so that the outer housing is rotated during the cleaning procedure. and ensure that it moves in relation to the cap.

In a preferred embodiment, the sealing and cleaning device includes a removable lid or closure attached to the outer housing to seal the device, thus isolating the internal space and structure of the device from the external environment. . Such a lid or closure is designed to ensure that the interior of the device, including the internal housing and compressible cleaning matrix, is removed by a health care professional, typically by a healthcare professional immediately prior to use of the cap and cleaning device on the cap. It is removed and then, if necessary, prevented from being exposed to the environment until the needle-free connector (e.g., needle-free medical valve) to which it is connected is cleaned/cleaned. In preferred embodiments, such cleaning substantially destroys any biofilm that may be present on the surfaces contacted by the compressible cleaning matrix. If desired, the sealing and cleaning device is placed in place (typically after cleaning the needleless connector attached to it) to cap the needleless connector until it is accessed further. can be left behind, thereby minimizing exposure of the capped exterior surface of the connector to potential pathogen contamination (and biofilm formation) from the surrounding environment. The seal is typically installed during manufacture of the sealing and cleaning device of the present invention. In embodiments where the cap and cleaning device are sterilized during manufacture (eg, by irradiation, exposure to ethylene oxide, etc.), it is preferred to apply the seal prior to sterilization.

Another aspect of the invention relates to a method of cleaning and/or sealing a needleless connector using a sealing and cleaning apparatus according to the invention. Such methods typically involve connecting the inner and outer housings after the device is connected to the needleless connector to allow the outer housing to spin or rotate relative to the inner housing. including transitioning the body from an engaged configuration to a disengaged configuration. Such compression facilitates contact between the compressible cleaning matrix of the device and the associated surface of the needleless connector. The spinning or rotation of the outer housing relative to the inner housing and the associated surfaces of the needleless connector allows these surfaces to be rubbed, thereby cleaning them. Preferably, such a cleaning method provides for the destruction of any biofilm present on the surface of the needleless connector associated with the sealing and cleaning device. and, in embodiments where the compressible cleaning matrix includes one or more antimicrobial reagents, microorganisms and pathogens present in such biofilms and/or on such surfaces are destroyed or rendered non-viable. be made into

As used herein, the compressible cleaning matrix of the sealing and cleaning device of the present invention includes one or more cleaning reagent species dispersed within a substrate. The cleaning matrix substrate covers the top surface of the site,
Allows effective friction-based cleaning of the site or portion of the needleless connector, including the sides and any threads or grooves if present, to be cleaned and provides a cleaning reagent at least at surface level. It can be any material that can be conformed, molded, or compressed in a fashion. Examples of compressible cleaning matrices include cotton, open or closed cell foam such as polyethylene foam, or other materials capable of holding or transporting cleaning reagents.

In some embodiments, the cleaning reagent species are dispersed or otherwise dispersed in a compressible cleaning matrix during the processing used to manufacture the seal and cleaning device.
In combination with a compressible cleaning matrix, while in other embodiments the device is configured such that the cleaning reagent is released for dispersion into the compressible cleaning matrix after manufacture, but the matrix is free of cleaning agents. The needle connector is configured to be released upon or prior to contact with the needle connector. The cleaning reagent can be any chemical, substance, or material that cleans a site of bacterial or viral microorganisms, biofilms, etc., or any carrier containing such a chemical, substance, or material. Examples of cleaning reagents include isopropyl alcohol,
Examples include chlorhexidine, chlorhexidine digluconate, povidone iodine, hydrogen peroxide, soap, and hydrochloric acid, silver ions and salts (eg, silver acetate, silver lactate, silver nitrate, etc.).

According to the invention, the cleaning reagent contains an active ingredient that is capable of cleaning the surface of the needleless connector. Any active ingredient that can be effectively used to quickly clean medical fittings or medical line connectors (e.g., needleless connectors) can be adapted for use in practicing the present invention, and Generally classified as antimicrobial and/or antimicrobial reagents, disinfectants or antimicrobial reagents, broad-spectrum disinfectants, and/or parasiticides, and combinations of such reagents. Since the device of the invention is intended for human and/or veterinary use, biocompatible cleaning reagents are particularly preferred, including alcohols, antibiotics, oxidizing reagents, and metal salts. Representative examples of such active ingredients include bleach, chlorhexidine, ethanol, isopropyl alcohol, hydrogen peroxide, sodium hydroxide, and iodophor, which may be prepared in a suitable solution, suspension, or emulsion. dissolved or dispersed in Other active ingredients with suitable cleansing effects can also be used. These are alcohols (e.g. ethanol, benzyl alcohol, isopropyl alcohol, phenoxyethanol, phenethyl alcohol, etc.); antibiotics (e.g. aminoglycosides (e.g. amikacin, apramycin, kanamycin, neomycin, netilmicin, paromomycin, streptomycin, and tobramycin); bacitracin; erythromycin; tetracycline; quinolones (e.g., oxolinic acid, norfloxacin, nalidixic acid, pefloxacin, enoxacin, and ciprofloxacin); penicillins (e.g., oxacillin and pipra conjugates); nonoxynol 9; fucid acid; cephalosporins Such)
including. Quaternary ammonium chloride, quaternary ammonium chloride, chlorinated phenol, fatty acid monoesters of glycerin and propylene glycol, iodine-containing compounds (3-iodo-
2-propynylbutyl carbamate (IPBC), etc.), iodophors (100% containing providine iodine as an active ingredient), hydantoins (dimethylhydantoin and halogenated hydantoin, etc.)
, parabens (methylparaben, ethylparaben, propylparaben, etc.), chloroxylene and its salts; chlorhexidine/silver acetate sulfadiazine; chlorhexidine (e.g. hibichlorlens); chlorhexidine hydrochloride; chlorhexidine sulfate; benzoic acid and its salts; benzethonium chloride ;Methylbenzethonium chloride;Chlorobutanol;Sorbic acid and its salts;
Butocoazole nitrate; Mafenide acetate; Nitromerzole; Triclocarban; Phenylmercuric nitrate or acetate (0.002%); Chlorocresol; Clindamycin; CAE (Anjinomoto) L-
DL-pyrrolidone carboxylate of cocoyl arginine ethyl ester; 0.2%, 0.02% and 0.0
02% concentration of cetylpyridinium chloride (CPC); 9.8% isopropyl alcohol; 1% ZnEDTA; mupirocin; and polymyxin (polymyxin b-bacitracin sulfate). Additionally, other beneficial compounds and compositions include miconazole, econazole, ketoconazole, oxiconizole, haloprogin, clotrimazole, butenafine HCl, naftifine, rifampicin, terbinafine, ciclopirox, tolnaftate, lindane, ramycaptate, Fluconazole, amphotericin B, ciprofloxecin, octenidine, triclosan (2,4,
4'-trichloro-2'-hydroxydiphenyl ether), microban (5-chloro-2phenol (
2,4 dichlorophenoxy)). Useful metals include silver acetate, silver benzoate, silver carbonate, silver citrate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein, and silver sulfadiazine. including silver and its salts. Cleaning reagents are often compositions containing the desired active ingredients mixed with other ingredients such as carriers and liquid solvents.

The particular active ingredient selected as the cleaning reagent for a given application is the compressible cleaning matrix and the compressible cleaning matrix used to form the outer housing, inner housing, and other components of a particular device. Material and compatibility. In some embodiments, the cleaning reagent is dispersed within the compressible cleaning matrix after the matrix is formed. For example, the cleaning reagent can be dispersed by saturating or supersaturating the compressible cleaning matrix during device manufacture, preferably before being sealed. In other embodiments, cleaning reagents may be dispersed during the process used to manufacture the compressible cleaning matrix. As understood, the materials used to prepare the cleaning reagents are needleless connectors
Before being used for cleaning (e.g., needleless medical valves), the substrate is compressible so that it does not appreciably degrade or otherwise suffer a loss of structural integrity. It should be compatible with one or more components including the cleaning matrix. Similarly, cleaning reagents should not harm the patient if they come into contact with needle-free medical devices, as well as materials used to form needle-free medical valves (or other needle-free connectors). It should be biocompatible so that a volume of cleaning reagent can be placed in the fluid carrying portion of the valve.

In preferred embodiments, the material used to form the compressible cleaning matrix can be wetted and/or impregnated with cleaning reagents, e.g., to engage upon contact with the needleless medical valve being cleaned. Any suitable absorbent, pliable, pliable, elastic, fibrous material that can easily and easily adapt to potentially complex surface contours (e.g. luer threads, concave and convex surfaces, flanges, etc.) , or a porous material, or a combination of materials. Such materials include those of composition or naturally occurring, and they may be of homogeneous or heterogeneous composition. Preferred synthetic materials include fibrous, foam (eg, felt foam), and gel compositions, particularly those having directionally oriented natural or synthetic fibers, or combinations thereof. Preferred natural materials useful as substrates include fibrous natural materials, including plant-based materials such as cotton and paper products, and animal-based textiles such as wool. Another preferred natural material is sponge.

As understood, to achieve the desired cleaning effect, a compressible cleaning matrix,
or a component thereof designed to come into contact with a needleless connector such as a needleless medical valve or a needleless connector such as a needleless medical valve. made of a material (or a combination of materials) that makes it possible to thoroughly clean surfaces exposed to and therefore at risk of contamination with infectious or pathogenic reagents, and biofilms containing them; It is also intended to form part of a fluid flow path for fluids introduced into the patient, such as IV solutions, drugs, blood and blood products.

Preferably, the material used to manufacture the compressible cleaning matrix is typically It should be sufficiently flexible to allow it to deform under the pressures experienced during use. This ensures close cleaning contact between the compressible cleaning matrix and at least those exposed surfaces of needleless connectors designed to come into contact with fluids entering the valve, such as, for example, IV fluids. . Furthermore, the compressible cleaning matrix preferably allows retention of liquid cleaning reagents within the void volume of, for example, capillary spaces, foams, sponges, and the like. The compressible cleaning matrix may also be engineered to include cleaning reagents such as silver ions and/or other suitable materials.

Preferred natural materials that can form compressible cleaning matrices include those derived from cotton and naturally occurring sponges. As those skilled in the art will appreciate, processed cotton fibers are composed almost entirely of natural polymeric cellulose. In such fibers, 20 to 30 layers of cellulose are coiled into a series of spring configurations, which makes the fibers absorbent and gives them a high degree of durability and strength. For example, woven cotton sheets, such as those often used in the manufacture of sterile cleaning pads that are saturated with a 70% isopropyl alcohol (IPA) solution, can be used as a substrate for cleaning elements according to the invention. Any suitable form can be used. For example, a woven cotton sheet can be cut into a number of similarly sized pieces, each of which can be used as a substrate. In many embodiments, (e.g., adhesive,
After attaching to the inner surface of the container layer (through the use of double-sided tape, etc.), the matrix is ready for the addition of appropriate cleaning reagents. Alternatively, cotton fibers can be spun onto the inner surface of the cap. Other fibers with similar properties, natural, synthetic, or a combination of natural and synthetic materials, can also be readily adapted for use as compressible cleaning matrices.

Another class of materials for compressible cleaning matrix production is directionally oriented fiber materials. These include, but are not limited to, materials consisting of cellulose fibers, glass fibers, and polyester fibers, as well as materials consisting of combinations of two or more of these and/or other materials. Such bonded synthetic fibers use capillary action to absorb, retain, transfer, and/or release liquids or vapors in precisely the desired amounts. A wide range of synthetic polymers can be used to form fibers and, if desired, they can be treated for functional purposes, e.g. to contain cleaning reagents dispersed therein, to improve the quality of the product. A vapor barrier or other coating may be provided over a portion of the surface, etc. Additionally, the geometries of these materials can be customized for specific applications, thereby allowing easy integration into substrate configurations with desired device thickness, width, length, diameter, etc. enable.

Other representative classes of materials suitable for use as compressible cleaning matrices include gel-forming polymers and foams (e.g., agarose, agar, polyacrylamide, and layers, sheets, etc. compatible with the practice of the present invention). , columns, or other synthetic porous materials that can be formed into other shapes). Typical gelatinous materials include hydrogels (i.e., cross-linked polymers that absorb and retain water), particularly those made from agarose, (2-hydroxyethyl) methacrylate and its derivatives, and the synthetic carbohydrate acrylamide. It will be done.

Still other types of materials include porous polymer sponges. Such sponges can be formed from any suitable material, including polyethylene, polypropylene, polytetrafluoroethylene, polyvinylidine difluoride, polynitrile, and polystyrene. Many such porous polymer sponges are commercially available in a wide variety of shapes, pore densities, sizes, etc. Additionally, polymeric sponges can be made by polymerizing appropriate monomers according to conventional foam forming techniques. Generally, sponges have an open pore structure to allow the movement of solvents, such as liquid cleaning reagents. The sponge surface should contain apertures to provide entry for liquid cleaning reagents (e.g., alcohol, iodine-containing solutions, etc.) and, like the other materials used to form the matrix, should be The particular material used is preferably inert, i.e., does not react with the components of the cleaning reagent, the body of the sealing and cleaning device, or the materials used to manufacture needleless connectors, such as needleless medical valves. .

Surgical foam is another preferred type of material that can be used to manufacture compressible irrigation matrices. Materials can be natural or synthetic, as desired. Suitable foams include rubber latex, polyurethane, polyethylene and vinyl foams. Preferably, such foams are made from any suitable biocompatible polymer, such as polyvinyl alcohol (PVA) or polyurethane. One preferred foam material is Microbisan, a hydrophilic polyurethane foam impregnated with silver ions.
(Trademark) (Lendell Manufacturing, St. Charles, MI). Preferably, such foams are highly absorbent and therefore suitable for use with liquid cleaning reagents. In other embodiments, the materials used to form the foam are well suited for dispersing dry cleaning reagents such as silver ions. Again, the foam material is preferably inert when used as a substrate. Additionally, these are preferably compatible with a variety of different shapes and surface configurations encountered in the art, given the large number of medical valve shapes, sizes, and configurations (e.g., dual seal fluid access points, luer threaded It is flexible enough to conform to mountains (e.g. mountains). In this way, sufficient contact between the cleaning surface of the sealing and cleaning device and the surface of the needleless connector to be cleaned can be ensured. Another advantage of some synthetic foams (as well as certain other polymeric materials from which the substrate may be formed) is that they can be easily injected at the desired volume into a shell or enclosure during manufacturing, after which they are expanded. The objective is to exhibit the desired substrate size, density, porosity, etc.

In addition, the compressible cleaning matrix may, for example, use a color change to indicate a change from wet to dry state, or alternatively, the matrix material may By being suitably wetted with a liquid cleaning reagent that is dispersed onto the substrate by a medical professional, the substrate can contain chemicals that exhibit a functional change therein. therefore,
Depending on the system used, a change in the color of the matrix can be used to indicate that the cleaning reagent in the compressible cleaning matrix has evaporated before use, thus possibly sealing and cleaning equipment storage containers. Certain cleaning equipment should not be used due to leakage inside. Alternatively, for example, if a colored liquid cleaning reagent is used, the user can visually confirm the dispersion of the reagent in the matrix by assessing whether the colored cleaning reagent is dispersed throughout the matrix. can. If colored cleaning reagents are used, the material is coated with the elastic inner body of the sealing and cleaning device and/or to allow easy visualization of any color changes before or during use of the sealing and cleaning device. Preferably, the cap is used to be transparent or translucent or contains one or more transparent or translucent windows.

The caps and cleaning devices of the present invention and their component parts (e.g., resilient inner bodies, caps, compressible cleaning matrices, sealing rings, sealing bodies, etc.) may be made from any suitable material and may be made from any suitable material. Can be assembled using any suitable process.

Preferably, the outer surface of the outer housing of the sealing and cleaning device that is intended to be grasped by the user has a non-slip surface, i.e. the outer part of the sealing and cleaning device is held in the user's fingers, and has a needleless connector. When the outer housing is rotated relative to the inner housing and the needleless connector, slippage between the device and the user's fingers (gloved or ungloved) is minimized. It has a high coefficient of friction so that it can be worn with or without gloves (with or without gloves). Examples of such non-slip (or high friction) surfaces include ridges, valleys, dimples, ridges, or other features designed to increase friction, as well as combinations of two or more such features. Includes those who have. Such features can be introduced on the exterior of the device as part of the manufacturing process. Alternatively, a non-slip coating may be applied to one or more of the outer surfaces of the outer housing.

Generally, the sealing and cleaning device of the present invention is provided to the user in a sealed and sterile condition. If desired, labeling information, logos, artwork, manufacturing, and/or regulatory data (e.g., lot number, expiration date, or "use by" date, etc.) can also be printed on individual sealing and cleaning devices. , or otherwise may be applied. Additionally, information such as a barcode (eg, to enable tracked device use) may also be included on individual sealing and cleaning devices.

As will be understood, the cleaning equipment may be packaged as a kit, individually or in groups of two or more units, and the kits may include instructions for use of the sealing and cleaning equipment, as well as other information, logos, May further include artwork, manufacturing, and/or regulatory data.

In a preferred embodiment, the packaged sealing and cleaning device is sterilized using a suitable process such as irradiation. In particularly preferred implementations, the sealing and cleaning device of the present invention is sterilized as part of the manufacturing process. Here, "sterilization" refers to effectively killing or eliminating transferable reagents (e.g. bacteria, viruses, fungi, prions, spores, etc.) that may be present on any component of the device according to the invention. Refers to any process. In preferred embodiments, sterilization may be achieved by heating, chemical treatment, irradiation, and other processes. In fact, any sterilization process compatible with the materials used to make the sealing and cleaning device can be used. A particularly preferred sterilization treatment is irradiation treatment. Such processes include irradiation with X-rays, gamma rays, or subatomic particles (eg, electron beams). Generally, when a sterilization process is used in the context of the present invention, this process is used for cleaning articles after they have been sealed and/or packaged. Chemical sterilization, e.g. ethylene oxide (EtO)
Sterilization can also be used.

The present invention also relates to a method of using the disposable sealing and cleaning device of the present invention. Such methods include using the device to clean and, if desired, cap a needleless connector, such as a luer access device. To perform such methods, the portion of the needleless connector that is cleaned is typically sealed and cleaned by a user (e.g., a nurse) after the user (e.g., a nurse) removes the seal over the opening of the device. is screwed into the central bore of the inner housing of the Such insertion brings the portion of the needleless connector into contact with (ie, irrigates) the compressible irrigating matrix portion of the device. In a preferred implementation, when the compressible cleaning matrix contacts the surface of the needleless connector to be cleaned, the outer housing automatically disengages the inner housing and the engagement portion within the outer housing, and the inner housing allowing rotation of the outer housing relative to the body;
Allows for needleless connectors to be releasably connected to pre-sealing and cleaning equipment. Such contact and cleaning action can be of any desired duration, with periods of about 1 second to about 10-20 seconds being particularly preferred.

After cleaning, the needleless connector can be removed from the sealing and cleaning device, after which the sealing and cleaning device can be discarded. Alternatively, after cleaning, the sealing and cleaning device can remain attached to the needleless connector, sealing a portion of it, sealing it, and cleaning it until the time that access to the needleless connector is desired. protect from contamination. At that point, the seal and cleaning device can be removed and discarded. If desired, the cleaning process can be repeated immediately prior to removal.

Immediately connect a medical reservoir containing fluid (e.g., a syringe containing a drug, an IV bag, etc.) to the cleaned needle-free connector after removing the seal and cleaning device from the cleaned needle-free connector. Can be done. In preferred embodiments where the cleaning reagent is a solution, the surface of the needleless connector is preferably dried (
or dry, for example by wiping with a sterile absorbent cloth or wipe
) (or dry) and this cloth or wipe can be dried or
(can be moistened with a volatile compatible solution such as ~100% alcohol). In preferred implementations, such cleaning methods result in at least a 2-fold, 5-fold, or 10-fold or more reduction in microbial contamination on the accessible surface(s) being cleaned. Even more preferably, the level of reduction is 100x, 103x, 104x, 105x of microbial contamination on accessible fitting surfaces.
It may exceed a 106-fold, 106-fold, or 107-fold reduction.

In addition to methods for cleaning accessible surfaces such as Luer access devices, the devices of the present invention can be used to clean peripheral IV lines, central IV lines, etc. configured to deliver fluid directly into a patient's bloodstream. or a method of reducing the risk of infection in a patient connected to a device such as a peripherally inserted central catheter. The risk reduction provided by the device of the invention is dependent on the age and condition of the patient, the condition being treated, the location where medical services are being delivered, the density of patients, the amount of contaminating microorganisms in the environment, and the air treatment within the healthcare facility. the quality of the equipment, the degree of training of the medical personnel responsible for cleaning the access devices, the methods used to periodically clean the medical instruments, the intervals between cleaning procedures, the specifics of the sealing and cleaning equipment. It may vary depending on many factors, such as the configuration, the specific configuration of the needleless connector, whether a sealing and cleaning device is left in the cleaned area of the needleless connector to provide a seal. Risk reduction can be established using any suitable method, for example by evaluating the HAI frequency in the presence and absence of a cleaning device according to the invention. A reduction in the risk of HAI infection of 1 to 100% or more (including up to 1000% or more) is envisioned through the use of the sealing and cleaning device according to the present invention. As will be appreciated, a reduction in infection risk (eg, HAI risk) translates into improved patient outcomes (through reduced morbidity and mortality) and reduced consumption in treating HAIs.

[Representative embodiment]
To further illustrate and explain certain preferred representative embodiments of the present invention, the reader will refer to the accompanying drawings, figures, which illustrate various particularly preferred embodiments of the sealing and cleaning apparatus of the present invention.
Targets 1-10. These preferred representative embodiments will be described below.

Figure 1 shows a representative sealing and cleaning device (10) of the present invention, its component parts (Figures (b) to (g)), and some of the devices related to the needleless connector (Figure (a)). The drawings ((a) to (g)) are shown. The component includes a cap portion (11) adapted to receive and retain a compressible cleaning matrix (80).
and a resilient inner body (30) associated with the cap portion (11), wherein the cap portion and the resilient inner body move independently of each other under some conditions while moving independently of each other under other conditions. Now, allow the cap parts (11) and prevent them from moving independently of each other.
Adapted to engage one or more complementary features of the cap portion. For example, after attaching the device (10) to the needleless connector (100) (creating a capped needleless connector (200)), the user applies pressure to attach the cap (10) to the needleless connector (100). By compressing against the device (
Compress the elastic inner body (30) of 10) and attach the cap (10) to the elastic inner body (30) and the needleless connector (
100). Such action brings the compressible cleaning matrix (80) into contact with the surface of the needleless connector (100) that is desired to be cleaned, such as, for example, the valve surface of a needleless medical valve. The rotation of the cap (10) relative to the connector (100) is
For example, creating friction that can disrupt biofilms that may be present on the valve surface of needleless medical valves;
This surface may be in the flow path of fluid traveling through the medical valve.

FIG. 2(a) is an exploded view of a representative sealing and cleaning device (10) and needleless connector (100) of the present invention. Visible is a cap (10), including a cap portion (11), in which a compressible irrigation matrix (80) and a resilient inner body (30) are disposed, and also a Luer base, which is a needle-free medical valve. includes a needleless connector (100) whose male end (105) has a collar (101) and a female threaded portion for connecting the valve to a complementary luer fitting female threaded portion of another needleless connector (not shown). It has a screw (102). Figure (b) shows the cap (10) shown in Figure (a) while still being sealed with the sealing body (90).
) is a cross-sectional side view of. As shown, the cap portion (11), the compressible cleaning matrix (
80), and the resilient inner body (30) are operably assembled. A compressible cleaning matrix (80) is preferably disposed within a matrix well (12) formed on the inner surface of the cap portion (11) and protruding therefrom. The height of the matrix well (12) should allow for retention of the compressible wash matrix (80), which in some embodiments is such that the cap is compressed by the user and the needleless connector (100) The needleless connector (100) may be sized to act as a stop that can be supported against the collar of the needleless connector (100) to which the cap is attached when rotated to clean a desired surface of the needleless connector (100).

Figures (c) and (d) of Figure 2 show a cap (10) threaded onto a medical valve (100) in a cap and flush configuration (Figures (c) and (d), respectively). Cap (1
The compressible irrigation matrix (80) of 0) compresses the valve surface of the valve stem portion (103) of the medical valve (100). In the sealed view, view (c), the cap (and compressible cleaning matrix (80)) is uncompressed. The diameter of the matrix well (12) is such that when the cap is pushed towards the medical valve (100) by a user wishing to clean the surface of the valve stem portion (103), the cap will Enables sliding on the mountain (102). Figure (d)
shows the cap (10) compressed against the medical valve (100). User-induced compression is
By compression of the elastic inner body (30) and the compressible cleaning matrix (80), the cap portion
Bring (11) close to the main body of the medical valve (100). This movement also results in the disengagement of the complementary mechanical retention features of the cap portion (11) and the resilient inner body (30), thus allowing the user to
(11) and the compressible cleaning matrix (80) of the cap to allow rotation relative to the valve surface, thereby allowing cleaning of that surface.

FIG. 3 shows six different views of a representative sealing and cleaning device of the present invention. Figures (a) to (c) are
The cap portion (11) and the resilient inner body (30) engage to rotate the cap (10) and therefore its associated compressible cleaning matrix (80) relative to the resilient inner body (30) of the device. The device (10) is shown in a static, uncompressed, non-rotatable position where it cannot be rotated.
Figures (d)-(f) show the cap portion (11) and its associated compressible cleaning matrix (80).
The same representative device (10) is shown with the cap portion (11) and the resilient inner body (30) in a movable relationship such that the cap portion (11) and the resilient inner body (30) can rotate relative to the resilient inner body (30) of the device. The inner surface of the resilient inner body (30) includes one or more (preferably two) tabs (35) that engage the threads of the needleless connector (100). In the embodiment shown, the outer surface of the resilient inner body (30) is designed to engage complementary spaced apart structures (e.g., ribs (18)) spaced on the inner surface of the cap portion (11). , including a plurality of teeth (33) or other structures spaced around the circumference of the resilient inner body. When the cap (10) is uncompressed, the teeth (33) engage the ribs (18) and effectively lock the cap portion (11) and the resilient inner body (30) together so that they Let them rotate together. This allows the cap (10) to be screwed onto the complementary Luer fitting of the needleless connector, for example using the tabs (35) on the inner surface of the resilient inner body (30), sealing Function (to remove the cap from the needleless connector, the process is reversed) is provided. Once secured to the needleless connector, the cap (10) can then be compressed by the user, which pushes the cap portion (11) towards the fitting of the needleless connector to provide a cleaning action. to compress the compressible cleaning matrix (80) against the surface of the connector (100) to be cleaned.

FIG. 4 shows a view of the cap portion (11) of a representative sealing and cleaning device (10) of the present invention. figure(
a) shows a top view of the cap part (11). In addition, on the outer surface of the cap portion (11),
Ridges and valleys are visible that enhance friction and allow the user to better grip or grasp the cap (10). Figure (b) shows a side view of the cap portion (11). Figure (c) shows a bottom view of the cap portion (11). In this embodiment, equidistant intervals (here:
Six ribs (or protrusions) (18) arranged at about 60 degrees in the center are visible. Ribs (18) are positioned and dimensioned to engage complementary features on the outer surface of resilient inner body (30) (not shown). The walls forming the matrix wells (12) can also be seen in this figure. Figure (d) shows a cross-sectional view of the cap part (11). Also shown is a well (20) formed by a matrix well wall (12) extending from the inner surface of the top of the cap portion (11), with a compressible cleaning matrix (80)
is designed to be accepted and retained. In a preferred embodiment, an adhesive (not shown) or other binding reagent is used to adhere the compressible wash matrix (80) to the inside of the well (20). The well (20) is spaced from the outer wall of the cap portion (11). The resulting space is sized and adapted for the insertion of the elastic inner body (30), and when complementary retaining features (e.g. ribs (18) and teeth (33)) of the cap portion (11) The cap part (11) can be rotated around it. In the exemplary embodiment of the sealing and cleaning device (10) of the invention depicted in the drawings, the upper surface (19) of the retaining part (18) present in the cap part (11) is located between the teeth (33). It is designed to engage with the lower surface of the lock groove (34).

FIG. 5 shows seven different views of the resilient inner body (30) of a representative sealing and cleaning device (10) of the present invention.
((a) to (g)) are shown. Representative measurements of this particular embodiment are shown in several figures. In this embodiment, two threaded tabs (
35) are shown, with twelve spaced teeth (33) engaging twelve complementary retainers (eg ribs (18)) on the inner surface of the cap portion (11). The resilient inner body (30) is adapted to be compressed by the user upon application of an appropriate force and rebound upon release of such pressure.

Figure 6 shows five different views ((a)-(e)), three of which depict the compressible cleaning matrix portion (80) of a representative sealing and cleaning device (10) of the present invention. show. Figures (a)-(c) show top, side, and bottom views of this particular compressible cleaning matrix (80). Preferably, the compressible cleaning matrix (80) is adhered to the surface of the matrix well (20) of the cap portion (11) using an adhesive. Figures (d) and (e) of Figure 6 show bottom and side views of the sealing portion (90) of a representative sealing and cleaning device of the present invention. The seal (90) is typically sized to seal or cover the opening that allows access to the interior of the cap (10). Preferably, the seal is such that it allows for gripping by the user so that the seal can be removed just before the device is used to cap and/or clean the needleless connector (100). Contains one or more configured removal tabs (91). Preferably, the sealing body has an inner surface (
It is adhered to the cap (10) using a suitable adhesive (94) applied to the cap (92). Outer surface of the sealing body (93
) often contains alphanumeric characters, barcode information, etc.

FIG. 7 (FIGS. 7A-7E) shows five different views of another exemplary sealing and cleaning device (300) of the present invention, in which a user squeezes (or (applying pressure using two or more fingers) to engage the inner housing (320) and the outer housing (301), slightly deforming the outer housing (301) and deforming the outer housing. The inner casing engaging part (311) present on the inner surface of the side wall is moved, so that the inner casing below the inner casing retaining part (322) on the outer surface of the side wall (321) of the inner casing The top of the outer casing (309), which is present on the outer surface of the body (320), is integrated with the side wall (302) of the outer casing. Figures 7B and 7E show exploded perspective views of the device to which the NC is connected (outer housing (301), compressible cleaning matrix (305), and inner housing (320)) and the NC (100).
reference). The NC (100) has a threaded valve region (105) that includes a collar (101) below the threaded portion (102).
A valve surface (110) is located on top of the threaded valve region (105). In Figures 7A-7E, the valves are not shown.

Figure 7B shows a perspective view of the assembled device (300) depicted in Figure 7A secured to the threaded region of the valve portion (105) of the NC (100) depicted in Figure 7A. Preferably, the plastic used to injection mold the outer housing (301) of the device (300) shown in this embodiment is the same as that of the inner housing (302).
) is softer than the plastic used to mold it. Preferably, the plastic used to form the outer housing is compatible with the inner housing to enable engagement between the inner housing and the outer housing engaging portions (326, 311). Flexible enough to be compressed by the user for the purpose of attaching and removing the outer housing engagement portion (300) from the NC (100), but allowing the outer housing (301) to return to its original shape and is therefore sufficiently resilient to allow the engagement portions (326, 311) of the inner and outer housings to be disengaged. This allows the user to, for example, rotate the engaging portions (326, 311) of the inner casing for a sufficient amount of time (e.g., 1 to 15 seconds or more) and/or a desired amount of rotation (e.g., 360 to 3,600 degrees or more). ) only without engaging in the same or different directions.
By rotating the device (300), the outer housing (301) and matrix 305 can be rotated relative to the NC (100) to clean its valve surface (110) when the cleaning operation is performed. can.

FIG. 7C is an exploded cross-sectional view of the components shown in FIG. 7A. Additionally, a tapered thin flexible lip seal (324) integrated into the top surface of the inner housing (320) includes a matrix cavity (303) from which a matrix retention rib (307) projects; User device (300)
is designed to engage a sealing surface (308) at the bottom of the matrix well that allows rotational forces applied to the compressible cleaning matrix (305) to be translated. Threads (326) on the inner surface of inner housing (320) are designed to engage complementary threads (102) on threaded region (105) of NC (100).

As understood and as shown in the figure. 7C-7E, compressible cleaning matrix (
305) is inserted into the matrix well (303) during manufacturing. The matrix (305) can be impregnated with a cleaning reagent (eg, silver ions) and, in a preferred embodiment, a liquid disinfectant, such as a 70% IPA solution. The bearing surface (323) of the outer housing retainer (322), here a tapered flange formed as part of the inner housing (320) during manufacturing, is connected to the main cavity (30) of the outer housing.
4) is designed to ride on a complementary bearing surface (310) located on the inner surface of. The inner housing retainer (306) of the outer housing (301) is inserted into the main cavity (304) of the outer housing after the inner housing is assembled with the outer housing into a functional subassembly during manufacturing. Hold the casing (320). For example, the inner housing may be inserted with a compressible cleaning matrix (305) followed by a liquid disinfectant (305).
For example, a 70% IPA solution) may be instilled, sealed, packaged, and pushed into the outer housing with sufficient force to join the functional subassembly ready for sterilization. The inner case engaging portion (311) present on the inner surface of the side wall (302) of the outer case is such that the outer case (302) is connected to the outer case engaging portion (311) on the adjacent outer surface of the inner case (320). 326).

FIG. 7D shows a cross-sectional view of the device of the present invention (outer housing ( 301), a compressible cleaning matrix (305), and an inner housing (320)). When the device (300) is attached to the NC (100), the NC contact surface of the matrix (305) contacts the valve surface (110) of the NC, causing the device (300) to
Its surface can be cleaned by the user rotating it against C. Figure 7E is a cross-section of screwing the sealing and cleaning device (300) of the present invention onto the NC, showing the compressible cleaning matrix (300).
5) resulting in compression against the valve surface (110) of the NC.

FIG. 8 (FIGS. 8A-8E) shows five different views of another exemplary sealing and cleaning device of the present invention.
This embodiment differs from the embodiment shown in FIG. 8 in that the seal is not a lip seal (324) located on the inner housing (320), but rather a matrix well (403) in the outer housing (401). ) in that the tapered downwardly extending encapsulant (408) is disposed on the bottom surface of the component forming the component shown in FIG.
(Figures 7A-7E) Similar to that depicted in m.

FIG. 8A shows an exploded perspective view of an embodiment (400) of the device (outer housing (401), compressible cleaning matrix (405), and inner housing (420)) and the device (400) is connected. NC (100) (see Figures 8B and 8E)
shows. Figure 8B shows a perspective view of the assembled device (400) depicted in Figure 8A secured to the threaded region of the valve portion (105) of the NC depicted in Figure 8A. Figure 8C shows an exploded cross-sectional view of the component depicted in Figure 8A, while in Figure 8D the cross-sectional view shows the functional component ready for installation in the threaded area of the valve portion of the NC depicted in Figure 8A. Figure 3 shows the components of the device of the invention (outer housing, compressible cleaning matrix, and inner housing) assembled into a sealing and cleaning device. FIG. 8E is a cross-sectional view showing the sealing and cleaning device of the present invention threaded onto the NC resulting in compression of the compressible matrix against the valve surface of the NC.

Specifically, FIG. 8 (FIGS. 8A-8E) shows that the inner and outer housings (420 , 401), slightly deforms and moves the inner casing engaging part (411) present on the inner surface of the side wall of the outer casing, and moves one or more (
Typically, the side opposite the outer housing (401) is attached to the inner housing retainer (42) on the outer surface of the side wall (421) of the inner housing.
The present invention (400) engages with the outer case engaging portion (426) present on the outer surface of the inner case (420) under 2).
5 shows five different diagrams of another representative sealing and cleaning device. The top of the outer casing (409) is integrated with the side wall (402) of the outer casing. FIG. 8A shows a device (outer casing (401)) to which the device (400) is connected;
An exploded perspective view of the compressible cleaning matrix (405) and the inner housing (420) and NC (100) is shown (see Figures 8B, 8E). NC (100) is a threaded valve area that includes a collar (101) below its threaded portion (102).
(105). A valve surface (110) is located on top of the threaded valve region (105). Figures 8A-8
In E, the NC (100) valve is not shown.

Figure 8B shows a perspective view of the assembled device (400) depicted in Figure 8A secured to the threaded region of the valve portion (105) of the NC (100) depicted in Figure 8A. Preferably, the plastic used to injection mold the outer housing (401) of the device (400) shown in this embodiment is the same as the inner housing (402).
) is softer than the plastic used to mold it. Preferably, the plastic used to form the outer housing is compatible with the inner housing to enable engagement between the inner housing and the outer housing engaging portions (426, 411). Flexible enough to be compressed by the user for the purpose of attaching and removing the outer housing engagement portion (400) from the NC (100), but allowing the outer housing (401) to return to its original shape and is therefore sufficiently resilient to allow the engagement portions (426, 411) of the inner and outer housings to be disengaged. As a result, the user can, for example, hold the engaging part (426) of the inner casing and the engaging part (411) of the outer casing for a sufficient period of time (for example, 1 to 15 seconds or more).
NC (100 ) by rotating the outer housing (401) and matrix 405 relative to its valve surface (1
10) Can be washed.

FIG. 8C is an exploded cross-sectional view of the components shown in FIG. 8A. In this embodiment (400),
A tapered, downwardly extending seal (408) is disposed on the bottom surface of the component forming the matrix well (403) within the outer housing (401). This sealing body (408) is attached to the holding part (422) of the inner casing (420).
) has a sealing surface 409 designed to seal against the sealing surface (423) of the tapered flange. As in the embodiment depicted in FIG. 7, for example, the inner housing (420) is inserted into the main cavity (404) of the outer housing so that the inner housing (401) is easily assembled with the outer housing (401). ),
By applying sufficient pressure at the point where the inner housing (420) passes past the inner housing retainer (406) of the outer housing, the inner housing (420) is forced into the main cavity (404) of the outer housing. ) is tapered to prevent it from being pulled out and to provide a smooth interface for easy access. Low friction rotation between inner and outer housing (420, 401) if required.

As understood and as shown in the figure. 8C-8E, compressible cleaning matrix (
405) is inserted into the matrix well (404) during manufacturing. The matrix (405) can be impregnated with a cleaning reagent (eg, silver ions) and, in a preferred embodiment, a liquid disinfectant, such as a 70% IPA solution. The bearing surface (424) of the outer housing retainer (422), here a tapered flange formed as part of the inner housing (420) during manufacturing, also connects to the main cavity (424) of the outer housing (
404) is designed to ride on a complementary bearing surface (410) located on the inner surface of the bearing surface (404). The inner housing retainer (411) of the outer housing (401) attaches the inner housing (420) to the main cavity of the outer housing after the inner housing is assembled into a functional subassembly with the outer housing during manufacturing. (404). For example, the inner housing may be pushed into the outer housing with sufficient force to join them into a functional subassembly ready for insertion of the compressible cleaning matrix 405, followed by a liquid disinfectant (e.g. 70% IPA solution), sealed, packaged, and sterilized. The inner casing engaging portion (411) present on the inner surface of the side wall (402) of the outer casing is such that the outer casing (401) is connected to the outer casing engaging portion (411) on the adjacent outer surface of the inner casing (420). 426).

FIG. 8D shows a cross-sectional view of the device of the present invention (outer housing ( 401), a compressible cleaning matrix (405), and an inner housing (420)). When the device (400) is attached to the NC (100), the NC contact surface of the matrix (405) contacts the valve surface (110) of the NC, causing the device (400) to
It is possible to clean its surface by the user rotating it against C. FIG. 8E is a cross-section of screwing the sealing and cleaning device (400) of the present invention onto the NC, resulting in compression of the compressible cleaning matrix (405) against the valve surface (110) of the NC.

FIG. 9 (FIGS. 9A-9E) shows five different views of another exemplary sealing and cleaning device of the present invention.
This embodiment is similar to that shown in FIG. 8 (FIGS. 8A-8E), the difference being that in the embodiment shown in FIG. 9, the outer housing (501) is wherein the sidewall (502) forming the structural part of the device (500) has a step therein, giving the exterior a layered "wedding cake" appearance. . To facilitate the user's grip of the device (500), a series of outer ribs (535) are provided on the outer top of the outer housing.

Specifically, FIG. 9 (FIGS. 9A-9E) shows five views of another exemplary sealing and cleaning apparatus (500) of the present invention.
2 different views, where the user has removed the inner casing (520) and outer casing (501) by squeezing (or applying pressure using two or more fingers) the outer casing (501). ), slightly deforming the outer casing (501) and moving the inner surface engaging portion (511) of the side wall of the outer casing, so that the outer surface of the side wall (521) of the inner casing The top of the outer casing (509) is located on the outer surface of the inner casing (520) below the inner casing holding part (522) of the outer casing (502). ). FIG. 9D shows an exploded perspective view of the device (outer housing (501), compressible cleaning matrix (505), and inner housing (520) to which the device (500) is connected, and the NC (100) (see Figures 9B and 9C).
The NC (100) has a threaded valve area (105) below its threaded portion (102) that includes a collar (101). A valve surface (110) is located on top of the threaded valve region (105). In Figures 9A-9E, the NC (100) valve is not shown.

Figure 9A shows a perspective view of the assembled device (500) depicted in Figure 9D secured to the threaded region of the valve portion (105) of the NC (100) depicted in Figure 9A. Preferably, the plastic used to injection mold the outer housing (501) of the device (500) shown in this embodiment is the same as that of the inner housing (502).
) is softer than the plastic used to mold it. Preferably, the plastic used to form the outer housing is compatible with the inner housing to enable engagement between the inner housing and the outer housing engaging portions (526, 511). For the purpose of attaching and removing the engagement portion (500) of the outer housing from the NC (100), the outer housing (501) is flexible enough to be used as a compression device by the user, but allows the outer housing (501) to return to its original shape. and is therefore sufficiently resilient to allow the engagement portions (526, 511) of the inner and outer housings to be disengaged. As a result, the user can, for example, hold the engaging part (526) of the inner casing and the engaging part (511) of the outer casing for a sufficient time (for example, 1 to 15 seconds or more) and/or for a desired time. outward relative to the NC (100) when the cleaning operation is performed by rotating the device (500) by an amount of rotation (e.g., 360 to 3,600 degrees or more) without engaging in the same or different directions. Rotate the housing (501) and matrix 505 so that its valve surface (110
) can be washed.

FIG. 9D shows an exploded cross-sectional view of the components depicted in the figure. 9A-9C. In this embodiment (500),
A tapered, downwardly extending seal (508) is disposed on the bottom surface of the component forming the matrix well (503) within the outer housing (501). This sealing body (508) is attached to the holding part (522) of the inner casing (520).
) has a sealing surface 509 designed to seal against the sealing surface (523) of the tapered flange. As in the embodiments depicted in FIGS. 7 and 8, for example, the inner housing (501) is removed from the inner housing to the point where the inner housing (520) passes beyond the retaining portion (506) of the outer housing. The inner housing is tapered for easy assembly by applying sufficient pressure to the parts to sufficiently inflate the body (520), at which point the outer housing (401) is deflated. Inner casing and outer casing (522)
The retaining parts (524, 510) 506 prevent the inner casing (520) from being pulled out from the outer casing (504), and prevent the inner casing (520) from being pulled out from the outer casing (520). contact to allow low-friction rotation, 501) as and when required.

As understood and as shown in the figure. 9B-9E, compressible cleaning matrix (
505) is inserted into the matrix well (504) during manufacturing. The matrix (505) can be impregnated with a cleaning reagent (eg, silver ions) and, in a preferred embodiment, a liquid disinfectant, such as a 70% IPA solution. The bearing surface (524) of the outer housing retainer (522), here also a tapered flange formed as part of the inner housing (520) during manufacturing, is connected to the outer housing main cavity (504). It is designed to ride on a complementary bearing surface (510) located on the inner surface.
The inner housing retainer (511) of the outer housing (501) attaches the inner housing (520) to the main cavity of the outer housing after the inner housing is assembled into a functional subassembly with the outer housing during manufacturing. (504). For example, the inner enclosure is ready for insertion of a compressible cleaning matrix (505), followed by instillation of a liquid disinfectant (e.g., 70% IPA solution), sealed, packaged, and sterilized. It may be pushed into the outer housing with sufficient force to couple the functional subassembly. The inner case engaging portion (511) present on the inner surface of the side wall (502) of the outer case is such that the outer case (501)
Enables engagement with an outer housing engagement portion (526) on an adjacent outer surface of the inner housing (520).

FIG. 9D, cross-sectional view shows the device of the present invention (outer housing (501), compressible cleaning matrix (505)
, and components of the inner casing (520)). When the device (500) is attached to the NC (100),
The NC contacting surface of the matrix (505) contacts the valve surface (110) of the NC and can be cleaned by the user rotating the device (500) relative to the NC. Figure 8E is a cross section of screwing the sealing and cleaning device (500) of the present invention onto the NC, resulting in a compressible cleaning matrix (505).
Compressed against the valve surface (110) of the NC.

Figure 10 shows that when the device (600) is screwed into the threaded valve area (105) of the needleless connector (100), the outer housing (601) is pushed upwardly by the compressible cleaning matrix (605). 3 shows three different cutaway views of another exemplary sealing and cleaning device (600) of the present invention. FIG. The upward movement is performed by placing the outer casing (601) in a neutral position where the engaging portions (611, 626) of the outer casing and the inner casing (601, 620) are disengaged; (601) can be rotated relative to the inner housing (620). figure. 10B and 10C show the device (600) fixed in the threaded area of the valve part (105) of the NC;
On the other hand, FIG. 10A shows the device (600) disconnected from the NC (100). FIG. 10B shows the outer housing of the device in a neutral position (the engagement portions of the inner and outer housings are not engaged), from which
The user can rotate the outer housing (and the compressible cleaning matrix) relative to the inner housing and the NC to which the inner housing is fixed. As will be appreciated, the compressible cleaning matrix (605) will push the outer housing (601) up against the inner housing (620) in the absence of sufficient counteracting downward force, allowing the user to may act as a spring or biasing member that allows the outer housing (and the compressible cleaning matrix) to rotate relative to the inner housing (620) and the NC. Without such rotation, while connected to the NC, the sealing and cleaning device (600) of the present invention is designed to protect the threaded valve area (105) of the NC from environmental contamination, including microbial contamination. Works as a cap. FIG. 10C shows the engaging portion (626,
611) is shown when engaged, allowing for screwing in and out of the NC (100).

In the embodiment shown in FIG. 10, the device (600) includes an encapsulant (630) disposed on the outer surface of the inner housing (620).
) is also included. The purpose of this seal is to prevent rapid loss of liquid cleaning reagent from the device after it has been attached to the NC, as the device according to the invention preferably remains attached to the NC for up to 7 days or more. It is to be.

As may be understood, in fig. 7-10, Lower surface of side wall of outer casing (301, 401, 501, 601) (3
40, 440, 540, 640) is a surface adapted to receive a lid or seal (not shown) to seal the interior space of the device (300, 400, 500, 600) from the external environment. This allows cleaning reagents to be retained in a compressible cleaning matrix (320, 420, 520, 620) until a specific one is used to cap and/or clean the needleless connector. It also makes it possible to maintain the sterility of the device.

Unless the context clearly requires otherwise, throughout the above description and the appended claims, the words "comprising", "comprising" and the like are to be interpreted in an inclusive rather than an exclusive or exhaustive sense. and words using the singular or plural number in the meaning "including, but not limited to," also include the plural or singular number, respectively. Furthermore, “this specification”
, "hereinafter,""above,""below," and words of similar meaning refer to this application as a whole and not to any particular portion of this application. When the word "or" is used in reference to a list of two or more items, it encompasses all of the following interpretations of the word: any of the items in the list, all of the items in the list. , and any combination of items in the list.

The foregoing description has been described with reference to specific embodiments for purposes of explanation. However, the above illustrative discussion is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many modifications and variations are possible in light of the above description. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, and will allow others skilled in the art to make various modifications as appropriate to the particular use contemplated. has enabled the invention and its various embodiments to be best utilized. Accordingly, this invention extends to all functionally equivalent structures, methods, and uses as come within the scope of the appended claims and as required by the rules of applicable law. is intended to be limited only to the extent that

Claims (12)

A sealing and cleaning device for a needleless vascular access connector having a threaded valve portion, the device comprising:
(a) an inner housing configured to allow the device to be screwed into and unscrewed from the threaded valve portion of the needleless vascular access connector;
(b) comprising a cavity in which said internal housing is arranged and configured to retain and engage said internal housing, but independent of said internal housing when not engaged with said internal housing; an outer housing that can be rotated;
(c) a compressible cleaning matrix retained within the outer housing, rotating with the outer housing and optionally impregnated with a disinfectant, optionally a 70% isopropyl alcohol solution;
A device comprising: 2. The device of claim 1, further comprising a removable seal sealing the interior from the external environment. 2. The device of claim 1, wherein the cleaning reagent comprises isopropyl alcohol, optionally a 70% isopropyl alcohol solution. 2. The device of claim 1, wherein the outer housing includes an outer surface having a plurality of vertical ridges. A method of cleaning a needleless vascular access connector, the method comprising:
(a) connecting a needleless vascular access connector to the sealing and irrigation device of claim 1, such that one or more surfaces of the connector engage the compressible irrigation matrix and the compressible compressing a portion of the cleaning matrix;
(b) if necessary, the outer housing is rotatable relative to the inner housing, and the outer housing is rotated relative to the inner housing and the connector to cleaning the surfaces connected by a cleaning matrix;
How to have. 6. The method of claim 5, further comprising sealing the needleless vascular access connector after cleaning by removing the needleless vascular access connector connected to the sealing and cleaning device. A sealing and cleaning device for a needleless vascular access connector having a threaded valve portion, the device comprising:
Comprising an inner housing, an outer housing, and a compressible cleaning matrix,
the inner housing has a substantially cylindrical sidewall defining a central bore open at upper and lower ends, an outer housing engagement region, and optionally an inner housing retention region;
Hold the needleless vascular access connector and, if necessary, release the needleless connector.
one or more threaded engagement tabs or threads configured to engage a threaded valve portion of a needleless vascular access connector are disposed proximate the lower end opening and on the central bore;
the outer housing engagement region is configured to allow mechanical engagement and disengagement of an outer housing of the device;
The outer housing holding area is configured to retain the inner housing within the cavity of the outer housing and retain the inner housing of the outer housing when the outer housing engagement area is disengaged. configured to allow rotation relative to the body;
The outer housing has a cavity formed by an outer wall and a top wall, optionally a concentric matrix well, and one configured to releasably engage and retain the inner housing within the cavity. Equipped with the above engagement and retention structure,
When the engagement structure engages with the inner casing, the inner casing and the outer casing can rotate together, and when the engagement structure is disengaged from the inner casing. , the outer housing is rotatable relative to the inner housing,
the compressible wash matrix includes wash reagents disposed therein and fixed to matrix wells of the outer housing;
The matrix contacts and contacts one or more surfaces of the needleless vascular access connector when the device is secured to the connector and the outer housing and the matrix are rotated relative to the inner housing. configured to wash;
the cleaning reagent is optionally a 70% isopropyl alcohol solution;
Device. 8. The device of claim 7, further comprising a removable seal sealing the interior from the external environment. 8. The device of claim 7, wherein the cleaning reagent comprises isopropyl alcohol, optionally a 70% isopropyl alcohol solution. 8. The apparatus of claim 7, wherein the outer housing includes an outer surface having a plurality of vertical ridges. A method of cleaning a needleless vascular access connector, the method comprising:
(a) connecting a needleless vascular access connector to the sealing and irrigation device of claim 7, such that one or more surfaces of the connector engage the compressible irrigation matrix and the compressible compressing a portion of the cleaning matrix;
(b) if necessary, the outer housing is rotatable relative to the inner housing, and the outer housing is rotated relative to the inner housing and the connector to cleaning the surfaces connected by a cleaning matrix;
How to have. 12. The method of claim 11, further comprising sealing the needleless vascular access connector after cleaning by removing the needleless vascular access connector connected to the sealing and cleaning device.