JP2022520491A - Sealing and cleaning device for needleless vascular access connectors - Google Patents

Abstract

Sealing and cleaning devices for sealing and cleaning luer access devices such as needleless connectors, in particular needleless vascular access connectors, and methods for using such devices are described. The device of the invention is a locked or engaged position that allows the user to rotate about the center axis of the device independently of the inner housing from the locked or engaged position. Interconnected inner and outer enclosures capable of transitioning between unengaged or disengaged positions, and a compressive cleaning matrix secured within the device (preferably wells within the outer enclosure). Includes). [Selection diagram] FIG. 1A

Description

The present invention covers medical devices, in particular cleaning devices for cleaning and capping luer access devices such as needleless valve connectors (NCs), as well as methods for making and using such articles.

[1.First of all]
The following description contains information that may be useful in understanding the present invention. All such information acknowledges that the invention currently claimed is prior art or related, or that the description specifically or implicitly referred to is prior art. It's not something to do.

[2. Background]
From potentially contaminated surfaces of luer access devices, such as needleless valve connectors (NCs), in the medical field, especially in the field of injecting fluid into a patient or inhaling fluid from a patient. There is still a need to prevent the transmission of pathogens to patients with. Pathogens include microorganisms such as bacteria, fungi, and viruses that, when transmitted to a patient, can cause potentially life-threatening infections. Specific to the medical setting, the term "nosocomial infection" means an infection that originates from or occurs in a hospital or hospital-like situation. 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, leading to significant morbidity, mortality, and costs. In fact, nosocomial infections are estimated to be more than double the risk of mortality and morbidity in all inpatients, with a high likelihood of about 100,000 deaths annually in the United States alone. Common sites for the transmission of contaminating microorganisms into the patient's bloodstream are on luer access devices, vials, needleless (or needleless) valves, and medical devices such as containers, tubes, and catheter inlets. Found in. The incidence of such infections in patients is increasing, and infection control practitioners (ICPs) often cite improper cleaning of the site as the primary source of infection for such infections.

As mentioned above, exposure of patients to pathogens and infectious reagents (eg, pathogenic bacteria, viruses, fungi, etc.) in medical settings (eg, hospitals, outpatient surgery centers, home care settings, etc.) is a serious concern. It is a matter. One route of exposure to such reagents is made 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 with impaired epidermis 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 the installation and use of peripheral venous catheters (PIVCs), and more than 80,000 bloodstream infections are associated with the use of central venous catheters (CVCs). All said that about 28,000 patients die each year in the United States from nosocomial infections resulting from the use of PIVCs and CVCs, a number of which are severe but alive. 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 professionals from needle sticks and similar injuries are, wherever possible, needleless medical valves (in this specification, "needleless connectors". Or "NC") brought about a deployment. Currently, over 1 billion NCs are used annually in hospitals throughout the US needleless connector, primarily with PIVC and CVC devices, as well as related IV dosing and expansion sets, which are only 1 It can contain from one to three, four, five, or more NCs. FIG. 2A shows an example of a typical NC used today.

The widespread use of needle-based connectors in acute care has contributed to a significant increase in the incidence of nosocomial infections (HAIs), especially bloodstream infections (BSIs). To reduce the risk of infection from microbially contaminated needleless connectors, today's standard practice is, for example, just before a nurse or other healthcare professional makes a fluid connection to the NC, for example. By attaching a syringe to the threaded valve portion of the NC to deliver the drug via PIVC already connected to the patient, by violently rubbing the outer surface in the flow path with a sterile alcohol cotton swab or wiping cloth. Needs to clean (or "rub") the surface of the NC. The magnitude of HAI-related mortality and morbidity, especially central venous line-related blood flow infection (CLABSI), and the use of PIVC and CVC (so-called "peripheral blood flow-related infection (PLABSI) and central venous line-related blood flow infection). (CLABSI) ”Given the large number of bloodstream infections resulting from each, the risk of initiating HAI simply by accessing the patient's vasculature via a PIVC or CVC needleless valve member inserted into the patient's blood vessels. There is still a long-recognized and significant unmet need for moldings or equipment that can be used to reduce or eliminate.

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

Unfortunately, alcohol swabbing (or scrubbing) is often inadequate or inadequate due to increased duties and responsibilities, reduced nursing staff, and inadequate training. Inadequate swabs can carry microorganisms that cause infections that can be serious and life-threatening if they can enter the patient's body. Also, supervision by supervisors is almost impossible, as it is not possible to know if scrubbing was done properly or if it was not done without actually observing the swab. In fact, reports of compliance with such a "hub cleaning" protocol are as low as 10%, and "hub cleaning" is performed without at least sufficient microscopic examination of microbial residues (eg, biofilms). There may be no evidence of it.

Therefore, it is clear that the site on the medical device is cleaned before use with the patient or before connection with the patient, eliminating technical and training issues and cleaning the site before accessing the patient's vasculature. There is still a significant need for equipment and technology to provide indicators.

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

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

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

A "patentable" composition, method, machine, or manufactured article according to an invention is one in which the subject matter in question meets all statutory requirements for patentability at the time the analysis was performed. Means that. For example, when it becomes clear that one or two or more claims include one or two or more embodiments denying novelty, non-obviousness, etc. with respect to novelty, non-obviousness, etc. , The claims are limited by definition to "patentable" embodiments, specifically excluding non-patentable embodiments. Also, the claims attached to this specification should be construed to maintain their validity and provide the broadest reasonable scope. In addition, if one or more of the statutory requirements for patentability have been amended, or if the criteria for determining whether a patent issue has been met have changed from the time the patent was filed, the claim shall be ( It will be interpreted in a way that 1) maintains its effectiveness and (2) provides the broadest interpretation under the circumstances.

"Multiple" means more than one.

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

An object of the present invention is to address these long-standing but unmet needs. The present invention can be contaminated with accessible surfaces of luer access devices, especially needleless connectors, especially the threaded valve portions of needleless connectors, especially pathogens or other infectious reagents, and external fluid sources (eg, eg). Effective and efficient on exposed surfaces of surfaces (valve surfaces, screws, etc.) that form part of the fluid communication path between the patient's blood flow (drug-filled syringe with male luer fitting, IV bag, etc.) These needs are addressed by providing a patentable single-use cleaning (disinfection) and cap device or article that can be used for cleaning / disinfecting and preferably sterilizing. In the context of the present invention, "cleaning" includes cleaning, disinfection, disinfection, and / or sterilization, and "sealing" is a device (ie, "cap") to cover a surface or set of surfaces of NC. For a longer period of time than required to clean the desired surface of the needleless connector, such a surface (eg, air circulating in a hospital intensive care room, patient's skin, clothing, bedding, etc.) It means limiting or preventing exposure to the environment (microbial flora present on unclean fingers, etc.).

Accordingly, in one aspect, the invention provides a cap and disinfectant device for a medical device such as a luer access device including a needleless valved vascular access connector (NC). Generally, such a device holds an inner enclosure configured to allow the apparatus to be screwed into and unscrewed from a threaded valve portion of the NC, and optionally. If there is an outer enclosure that can rotate independently of the inner enclosure to provide cleaning or disinfecting action, and preferably with a compressible cleaning matrix impregnated with a disinfectant, eg 70% IPA solution. including. The device is also preferably maintained sterile and easily removed to prevent loss of disinfectant after the device has been assembled until it is used in the field to clean the NC outer housing. Includes possible encapsulants.

The apparatus of the present invention includes an inner housing. In some preferred embodiments, the inner enclosure is bounded by an internal (preferably cylindrical) bore in the middle of the period between the opposed first and second (top and bottom, respectively) openings. It consists of side walls. In many of these embodiments, the first (upper) opening has a compressible wash matrix present at least partially within the matrix well, or otherwise attached to the inner surface of the outer enclosure. The compressible cleaning matrix is sized to allow it to project into and through the opening into the central bore of the inner enclosure, so that the sealable and cleaning device is attached to the connector. When secured, it may engage one or more outer surfaces of a needleless connector. The second (lower) opening of the inner enclosure is capped and / or cleaned of the threaded valve portion of the unwanted connector for insertion into the sealing and cleaning device of the present invention. It is a size that enables. The inner wall of the central bore of the inner enclosure is located (or otherwise spaced) on the opposite side of one or more thread engagement tabs (or threads), preferably two (or more). (Placed) thread engagement tabs are preferably included near the lower opening. The thread engagement tab is configured to engage, for example, a complementary thread area on the outer surface of the needleless connector so that the sealing and cleaning device is threaded on the interior of the central bore of the inner enclosure. Through the association of the tab or thread with the complementary thread on the thread portion of the needleless connector, on the target thread portion of the needleless connector for sealing and, if desired, cleaning. Can be screwed in firmly (or otherwise detachably connected to it).

In some preferred embodiments, the outer surface of the inner enclosure is one or more complementary structures (eg, circumferential flanges (or spaced flanges) or other) on the inner surface of the side wall of the outer enclosure. Includes one or more structures, eg, circumferential flanges (or spaced flanges), that allow the inner enclosure to be retained within the outer enclosure through association with the appropriate engagement portion). Includes outer housing holding area. Preferably, such a configuration of the complementary retainer also provides a smooth, low friction transfer (ie,) of the inner and outer enclosures to each other during certain operations, eg, disinfection of the needleless connector. , Rotation) is possible. In some of these embodiments, the retainer of the inner enclosure applies, for example, sufficient force to the outer enclosure for the user to press or otherwise deform the outer enclosure. Allows the engagement area on the inner surface of the outer housing to engage with the corresponding engagement area on the outer surface of the inner housing, allowing the inner and outer housings to rotate in unison. (For example, as it happens when the user attaches the device to the NC or removes the device from the NC), it can be mechanically engaged with an adjacent area on the inner surface of the side wall of the outer housing. In some of these embodiments, the holding portion (s) of the inner enclosure is adjacent to it as an engaging portion having complementary regions, features, or structures on the inner surface of the sidewall walls of the outer enclosure. Or else it can be useful in close proximity to it. In other embodiments, the outer surface of the inner enclosure is one or more outer casings designed to be associated with one or more inner enclosure engagement portions or regions located on the inner or inner surface of the outer enclosure. Further includes a body engagement portion or area. Examples of such members include, for example, a circle of separated teeth or members such as teeth that project from the outer surface of the internal containment and are positioned below the outer housing holding area (eg, circumferential flange). Circumferential bands are included and these teeth (or other suitable engagement structures) are engaged by a complementary structure arrayed on the inner surface of the outer enclosure when the containment is assembled into a functional subassembly. be able to.

In another preferred embodiment, the upper outer surface of the inner enclosure is mechanically engaged with a complementary structure (eg, a claw or other suitable engagement portion) on the inner surface of the upper portion of the outer enclosure. Includes an outer housing engagement area containing one or more structures that allow the outer and inner housings to be in close proximity to the outer and inner housings. The engaging portions engage, allowing the outer and inner enclosures to rotate simultaneously. Certain preferred embodiments of the outer housing engagement structure include separated teeth (or other suitable engagement portions) arranged on the top or top surface of the preferably cylindrical side wall of the inner housing. As will be appreciated, when such inner housing engaging portions and outer housing engaging portions are disengaged or disengaged, the user can use, for example, a needleless connector to which the device of the invention is attached. The outer enclosure can be rotated or rotated relative to the inner enclosure as is done during a cleaning or disinfection operation. Therefore, when the sealing and cleaning device is secured to the needleless connector, such engaging parts are not functionally associated (or not fitted or otherwise engaged). If so, the user can rotate the outer enclosure (and the compressible wash matrix) with respect to the inner enclosure and the connected needleless connector. On the other hand, if the inner surface of the top of the outer housing and the complementary members on the upper surface of the top of the inner housing are engaged (totally or even partially), for example, the user exerts downward pressure on the device. If the device is placed on the needleless connector or the device is removed from the needleless connector, the inner and outer enclosures rotate together and, for example, a sealing and cleaning device is attached to the NC. Allows it to be removed or removed from the NC.

In some preferred embodiments, the inner enclosure is also configured to provide a fluid-sealed sealant between the sealing and cleaning device of the present invention and a needleless connector connected thereto. Including members. In some embodiments, the NC encapsulant is an O-ring (or equivalent encapsulant), preferably in close proximity to the second (lower) opening, typically screwing. Under the combined tab (s), it is placed within a channel formed on the inner surface of the wall of the inner enclosure.

The apparatus of the present invention can also rotate the outer enclosure with respect to the inner enclosure (preferably around its central axis) under certain conditions when the apparatus is attached to a needleless connector. As such, it includes an outer housing adapted or configured to hold the inner housing therein. Using a facing or complementary mechanical or structural feature on the facing or a suitable form of a member, the device provides needleless connector to hold the inner housing within the main cavity of the outer housing. To allow the outer enclosure to rotate relative to the inner enclosure if attached and the user wishes to clean the corresponding surface of the NC using the sealing and cleaning equipment of the present invention. It is possible to engage and disengage the outer housing from the inner housing.

In some embodiments, when the device of the invention is attached to a needleless connector, the inner and outer enclosures rotate the outer enclosure with respect to each other and the user with respect to the inner enclosure. Adopt an outer housing, neutral or rotating configuration so that the cleaning operation can be performed on the valve portion of the NC to which the is attached. Such disengagement, neutral, or rotational configurations can be achieved by any suitable approach, which, under certain conditions, eg, the outer enclosure is pulled up by the user relative to the inner enclosure. When pressed, pushed down, or squeezed, they engage with each other; otherwise, the engagement remains disengaged, which is the outside relative to the inner enclosure when the device is secured to the NC. Includes providing a complementary engagement or structure on the adjacent surface of the inner enclosure that allows rotation of the enclosure. Features that allow transitions between engaging and disengaging positions include springs or urging or elastic parts or materials. In another embodiment, when the device is attached to a needleless connector, the inner and outer enclosures disengage the engagement and thus the outer enclosure rotates independently of the inner enclosure. Adopt an engagement configuration with each other so that they rotate in unison unless the user applies sufficient force to the outer housing to enable.

The outer enclosure accepts the inner enclosure, if desired, and if desired, using one or more features or members that allow the outer enclosure to rotate relative to the inner enclosure. Includes a cylindrical cavity designed to hold. The cavity is formed by a curved outer side wall, which in some embodiments is joined to the top of the enclosure around its perimeter and is also preferably concentric central matrix wells or matrix mounting areas. Has, or is attached to it, or otherwise associated with a compressible wash matrix, but in some embodiments, to some extent between the matrix well and the central axis of rotation of the outer enclosure. Eccentricity may be desired. In some embodiments, the outer enclosure 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 is designed to releasably engage complementary structures within the outer housing engagement area of the top of the inner housing. Includes inner housing engagement or structure (eg, teeth). By engaging the inner housing engagement structure of the outer housing with that within the outer housing engaging area of the inner housing, for example, the inner housing of the cap and cleaning device is cleaned and / or capped. The user can rotate the outer and inner enclosures simultaneously when screwed into the threaded portion of the needleless connector. When the device is releasably secured to the needleless connector via the inner enclosure, the inner enclosure engagement or structure of the outer enclosure is, for example, by the urging action or elasticity of a compressible cleaning matrix. The inner enclosure may be disengaged (or disengaged) from the engaging portion of the outer enclosure, thereby allowing the user to rotate the outer enclosure around its central axis with respect to the inner enclosure. Enables. A representative example of such an engagement structure is shown in U.S. Patent Publication No. 2018/0304067, but the outer housing allows contact with the surface of the needleless connector when the former is connected to the latter. Features such as an inner enclosure with an opening at the apex are also envisioned to allow the compressible cleaning matrix attached to the inner surface of the apex to extend into the bore of the inner enclosure.

In some of these embodiments, the outer enclosure is one or more vents that allow fluid and / or air to escape from inside the device when the sealing and cleaning device is secured to the needleless connector. A mouth can be included, while in other embodiments no vent is provided. In embodiments with one or more vents, a membrane, filter, or other permeable or semi-permeable barrier is used to allow unidirectional or bidirectional flow of air, gas, or vapor through the vents. Although it is possible, it is possible to prevent microorganisms (eg, bacteria, fungi, viruses, etc.) from moving into the sealing and cleaning device of the present invention.

In certain preferred embodiments, the outer surface of the outer enclosure of the sealing and cleaning device according to the invention comprises one or more grip reinforced structures (eg, multiple vertical ridges) or coatings. Such a grip-enhanced structure or coating makes it easier for the user to grasp the containment of the sealing and cleaning device between the fingers, not only during the insertion and removal of the needleless connector from the cap cleaning device. It can also be useful during the cleaning process, in which case the user rotates the outer housing relative to the inner housing to expose the surface of the inserted needleless connector with the device's compressible cleaning matrix. Rubbing, thereby cleaning or cleaning.

In some embodiments, the apparatus of the invention comprises one or more members or features arranged on facing surfaces of the inner and outer enclosures, whereby the user is fitted with the device. It is possible to detect that the outer housing is rotating with respect to the inner housing in order to give a cleaning action on the valve surface of the NC. Such sensory feedback can include one or more of auditory, tactile, and / or visual stimuli generated from the device by rotation of the outer enclosure with respect to the inner enclosure.

In the apparatus of the present invention, the inner and outer enclosures are manufactured separately by any suitable process, such as 3D printing, injection molding, etc., followed by one or more complementary retention on each enclosure. A part, mechanism, or structure assembles the inner enclosure into a two-part subassembly that is held within the main cavity of the outer enclosure. The inner and outer enclosures also allow the inner and outer enclosures to rotate together, or allow the outer enclosure to rotate independently of the inner enclosure. Includes complementary mechanical or structural engagements, features, or structures on one or more interface surfaces that can be engaged and disengaged. In this way, the inner and outer enclosures can be associated so that they can rotate in harmony, and the user can optionally device on the threaded valve portion of the NC. Allows the device to be screwed (or screwed in) or removed (unscrewed) from the threaded valve portion of the NC, while allowing the user to rotate the outer enclosure with respect to the inner enclosure. And thereby allowing the compressible wash matrix to effectively clean or clean the area of the threaded valve portion of the NC to which it is attached. In certain preferred embodiments, the inner and outer enclosures are complementary mechanical or structural containment seals that allow the formation of a seal between adjacent surfaces of the inner and outer enclosures. Further comprising parts, features, or structures on one or more interface surfaces, the encapsulation is preferably substantially fluid-tight, but during the performance of the user's cleaning procedure or process, the inner enclosure. It does not substantially obstruct or suppress the rotation of the outer housing with respect to. In some embodiments, the inner enclosure may also include a sealant that interacts with a needleless connector to form an additional or alternative sealant.

The sealing and cleaning device of the present invention also includes a compressible cleaning matrix placed therein. In most embodiments, the compressible wash matrix is placed in a matrix well or the like inside the outer enclosure, but the compressible wash matrix is rotated in conjunction with the rotation of the outer enclosure and is compressible. Any suitable retention configuration that allows the cleaning matrix to be used to rub the surface of the valve area of the needleless connector, or otherwise to provide the ability to clean, clean, or disinfect. Can be adopted. As will be appreciated, the compressible cleaning matrix is placed in contact with one or more outer surfaces of the NC connected to the sealing and cleaning equipment. A compressible wash matrix, such as open cells or felt foam, is preferably held in the matrix well by one or more matrix retainers, which members are during the procedure for disinfecting or cleaning the needleless connector. In addition to the transfer of rotational force from the outer enclosure to the compressible wash matrix, as it occurs in, aids in the retention of the compressible wash matrix in the matrix wells. As will be appreciated, during such rotations (of the outer enclosure and compressible wash matrix), the compressible wash matrix will also disinfect or clean the needleless connector during the outer enclosure. When is rotated, it rotates with respect to the inner housing. The compressible cleaning matrix attached to or otherwise associated with the outer enclosure compresses axially (ie, the matrix wells of the outer enclosure when a needleless connector is inserted into such a sealing and cleaning device. Can be compressed along the central axis).

The surface of the needleless connector to be cleaned adheres the biofilm-forming microorganisms (ie, a matrix of microorganisms and microorganisms, typically bacteria and / or fungi, to the surface and performs certain biochemical processes. The compressible wash matrix also preferably has sufficient mechanical integrity when compressed and rotated, eg, because it can be contaminated with an extracellular material attached to the surface that allows it, for example. The surface of the needleless connector by rotating the outer housing (where the compressible cleaning matrix is attached) to the needleless connector to which the inner and inner housings of the sealing and cleaning device are releasably attached. Any biofilm that can be present on the surface of the needleless connector, as can be produced by rotating, twisting, or otherwise moving any biofilm that may be on the needleless connector. Allows the destruction of biofilms. The friction that occurs between the compressed wash matrix and the surface of the needleless connector destroys the biofilm, thereby cleaning and preferably sterilizing the needleless connector. After such a cleaning operation, leaving the sealing and cleaning device secured (ie, capped) to the needleless connector will cause the biofilm to re-grow and / or contact the cleaned surface (contact with a compressible cleaning matrix). The re-colonization of the microorganisms (which remain) is restricted and preferably hindered.

In a preferred embodiment, the compressible wash matrix preferably comprises one or more wash reagent species dispersed therein at the time the device is manufactured, whereas in some embodiments the wash reagent is. The matrix may be dispersed in the matrix just before it contacts the needleless connector. In the latter type of embodiment, the cleaning reagents are preferably housed within the enclosure of a sealing and cleaning device in a reservoir configured to burst immediately prior to performing the cleaning operation. In some embodiments, the sealing and cleaning apparatus of the present invention includes a valve or opening that allows the liquid in the cleaning reagent to evaporate.

In some preferred embodiments, the compressible wash matrix comprises two or more components. In some of 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 a needle. None Between the protruding thread areas adapted to engage the complementary threads on the connector. If present, the components of the compressible wash matrix secured to the inner surface of the inner housing wall are preferably configured to compress radially in association with the needleless connector to be capped and washed. ..

In a preferred embodiment, the sealing and cleaning device of the present invention comprises a removable lid or seal attached to the outer housing to seal the device, and thus the interior of the inner and outer housings. Separate space and structure from the external environment. Such lids or seals are typically removed by a healthcare professional just prior to using the seal and cleaning device to clean, clean, or disinfect the needleless connector through which the fluid connection is made. Prevents the interior of the device, including the internal enclosure and compressible wash matrix, from being exposed to the environment until the possible (preferably removable) lid or seal is removed. In a preferred embodiment, such cleaning substantially destroys any microbial contamination that may be present on the surface contacted by the compressible cleaning matrix, such as microbial biofilms or other microbial contamination. If desired, the sealing and cleaning device is in place (typically after cleaning the needleless connector attached to it) to cap the needleless connector until the needleless connector is further accessed. It can be left behind, thereby minimizing the exposure of the NC's capped external surface to potential pathogen contamination (and biofilm formation) from the surrounding environment. The lid or seal is typically attached during the manufacture of the sealing and cleaning equipment of the present invention. In embodiments where the cap and cleaning device are sterilized during production (eg, by irradiation, exposure to ethylene oxide, etc.), the lid or encapsulation 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 on a single piece of lid or sealed stock, and then they are sealed. May be separated into individual sealed products or maintained in band form, it is a band form having multiple devices all sealed in a single band, such a band, eg. Because it is a convenient form for use in a medical environment, it can be hung from the IV pole of the patient's bedside. After encapsulation and packaging, the device of the invention is any suitable sterilization method suitable for the material used to manufacture the particular device of the invention (eg, gamma or electron beam irradiation, treatment with ethylene oxide, etc.) ) Is sterilized.

Another aspect of the invention relates to a method of cleaning and / or sealing a needleless connector using the sealing and cleaning apparatus according to the invention. Such a method typically involves disengaging the engaging portions of the outer and inner housing enclosures after being connected to the needleless connector, thus allowing the user to disengage the inner housing. And the device of the present invention makes it possible to rotate or rotate the outer housing with respect to the needleless connector to which it is fixed. Such detachment does not impair the contact between the device's compressible cleaning matrix and the associated surface of the needleless connector. The spin or rotation of the outer enclosure with respect to the inner enclosure, and the associated surfaces of the needleless connector allow these surfaces to be rubbed, thereby cleaning them. Preferably, such a cleaning method provides 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 wash wash matrix contains one or more antibacterial reagents, microorganisms and pathogens present in and / or on such surfaces in such biofilms, is it preferably destroyed? , Or be made unsurvivable.

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

These and other embodiments will be described in detail below with reference to the drawings below. Unless otherwise noted, it should be understood that the drawings are not in scale, as they are intended merely to facilitate understanding of the invention, not to specific dimensions or the like. In drawings, similar numbers in more than one drawing represent similar components.

Some drawings ((a)-()) of a representative sealing and cleaning device of the present invention, its components (FIGS. (B)-(g)), and an apparatus related to a needleless connector (FIG. (A)). g)) is shown. An exploded view (a) and a needleless connector of a typical sealing and cleaning device of the present invention, and some cross-sectional views of a typical sealed and cleaning device of the present invention ((b)-(d)). ), As well as such sealing and cleaning devices (c) and (d)) that seal the needleless connector. Six different figures of a representative sealing and cleaning device of the present invention are shown. Figures (a)-(c) show the device in a stationary position, where the cap and elastic inner body are the cap, and thus the compressible cleaning matrix associated therewith is relative to the elastic inner body of the device. Engaged so that it cannot rotate. Figures (d)-(f) show that the cap and the elastic internal body are in a movable relationship so that the cap (and its associated compressible cleaning matrix) can be rotated with respect to the elastic internal body of the device. The same representative device is shown. The figure of the cap part of the typical sealing and cleaning apparatus of this invention is shown. FIG. (A) shows a top view of the cap portion. FIG. (B) shows a side view of the cap portion. FIG. (C) shows a bottom view of the cap portion. FIG. (D) shows a cross-sectional view of the cap portion. Representative measurements of this particular embodiment are shown in Figures (b) and (d). Seven different views ((a)-(g)) of the elastic inner body portion of a typical sealing and cleaning device of the present invention are shown. Representative measurements of this particular embodiment are shown in some figures. Five different figures ((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 wash matrix. FIGS. (D) and (e) show a bottom view and a side view of a sealing portion of a typical sealing and cleaning device of the present invention. Five different figures of another representative sealing and cleaning device of the present invention are shown. 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). FIG. 7B shows a perspective view of the assembled device depicted in FIG. 7A secured to the threaded region of the valve portion of the NC depicted in FIG. 7A. Figure 7C shows an exploded cross-section of the components depicted in Figure 7A, while in Figure 7D the cross-section is functionally ready to be attached to the threaded area of the valve portion of the NC depicted in Figure 7A. The components of the device of the invention (outer housing, compressible cleaning matrix, and inner housing) assembled into a sealing and cleaning device are shown. FIG. 7E is a cross-sectional view showing a sealing and cleaning device of the invention screwed into an NC resulting in compression of the compressible matrix against the valve surface of the NC. Five different figures of another representative sealing and cleaning device of the present invention are shown. FIG. 8A shows an exploded perspective view of the equipment to which the equipment is connected (outer enclosure, compressible cleaning matrix, and inner enclosure) and NC (see FIGS. 8B, 8E). FIG. 8B shows a perspective view of the assembled device depicted in FIG. 8A secured to the threaded region of the valve portion of the NC depicted in FIG. 8A. FIG. 8C shows an exploded cross-section of the components depicted in FIG. 8A, while in FIG. 8D, the cross-section is functionally ready to be attached to the threaded area of the valve portion of the NC depicted in FIG. 8A. The components of the device of the invention (outer housing, compressible cleaning matrix, and inner housing) assembled into a sealing and cleaning device are shown. FIG. 8E is a cross-sectional view showing a sealing and cleaning device of the invention screwed into an NC resulting in compression of the compressible matrix against the valve surface of the NC. Five different views of another representative sealing and cleaning device of the invention are shown, with FIG. 9A showing a perspective view of the device secured to the threaded region of the valve portion of the NC. 9B and 9C show exploded sections of the appliance / NC assembly shown in FIG. 9A, respectively. The difference is that the figure shown in Figure 9C is slightly rotated about the central axis of the device / NC assembly compared to the figure shown in Figure 9B. FIG. 9D shows an exploded perspective view of the device (outer housing, compressible cleaning matrix, and inner housing) depicted in FIGS. 9A-9C. FIG. 9E shows the side cross section and bottom view of the device depicted in FIGS. 9A-9D. Three different notches are shown for another representative sealing and cleaning device of the present invention. figure. 10B and 10C show the device fixed to the threaded area of the valve part of NC, and FIG. 10A shows the device separated from NC. FIG. 10B shows the outer enclosure of the device in the neutral position (the engagements of the inner and outer enclosures are not engaged), from which the user can see the inner and inner enclosures. The outer enclosure (and compressible wash matrix) can be rotated relative to the fixed NC. As will be appreciated, the compressible matrix pushes the outer housing up against the inner housing in the absence of sufficient reaction downward force, allowing the user to relate to the inner housing and NC the outer housing (the outer housing (). And the compressible wash matrix) can be rotated and, if desired, act as a spring to push up the outer housing. In the absence of such rotation, the sealing and cleaning equipment of the present invention acts as a cap to protect the threaded valve region of the NC from environmental pollution, including microbial contamination, while connected to the NC. FIG. 10C illustrates a device when the engaging portions of the inner and outer enclosures are engaged, allowing the device to be screwed into or unscrewed from the NC.

Details of one or more embodiments will be revealed in the accompanying drawings and the following description. Other features and advantages will become apparent from the description and drawings, as well as the claims.

[Detailed explanation]
In the following detailed description, the attached drawings (FIGS. 1 to 10) forming a part thereof are referred to. In the figure, similar symbols typically identify similar components unless the context dictates otherwise. The detailed description, drawings, and exemplary embodiments described in the 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, especially needleless pharmaceutical valves that are sometimes part of a fluid communication path for introducing fluid (eg, IV fluid, blood, plasma, drugs, etc.) into a patient. Since the exposed surfaces of the luer access device are at risk of contamination by pathogens and infectious fluids such as bacteria, fungi, and viruses, these exposed surfaces are effectively and efficiently cleaned, disinfected, and preferably sterilized. With respect to patentable single-use caps and cleaning equipment 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 "double" or "multiple" use or purpose device. In the context of the present invention, a "single-use" sealing and cleaning device is useful, for example, for cleaning needleless medical valves. To prevent recontamination of the cleaned surface of the connector, as would occur if, after a cleaning operation, the sealing and cleaning device of the present invention was removed immediately after "cleaning" the connector without fluid connection. And, 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, prior to 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 holds an inner housing configured so that the device can be screwed into a threaded valve portion of the NC and unscrewed, and an inner housing, if desired. Includes an outer enclosure that can rotate independently of the inner enclosure to provide cleaning or disinfecting action, and a compressible cleaning matrix impregnated with a disinfectant, eg, a 70% IPA solution. .. The device is also preferably maintained sterile and easily removed to prevent loss of disinfectant after the device has been assembled until it is used in the field to clean the NC outer housing. Includes possible encapsulants.

Generally, such a device holds an inner enclosure configured to allow the apparatus to be screwed into and unscrewed from a threaded valve portion of the NC, and optionally. If there is an outer enclosure that can rotate independently of the inner enclosure to provide cleaning or disinfecting action, and preferably with a compressible cleaning matrix impregnated with a disinfectant, eg 70% IPA solution. including. The device is also preferably maintained sterile and easily removed to prevent loss of disinfectant after the device has been assembled until it is used in the field to clean the NC outer housing. Includes possible encapsulants.

The apparatus of the present invention includes an inner housing. In some preferred embodiments, the inner enclosure is bounded by an internal (preferably cylindrical) bore in the middle of the period between the opposed first and second (top and bottom, respectively) openings. It consists of side walls. In many of these embodiments, the first (upper) opening has a compressible wash matrix present at least partially within the matrix well, or otherwise attached to the inner surface of the outer enclosure. The compressible cleaning matrix is sized to allow projection into the opening and through the opening into the central bore of the inner enclosure, so that the seal and cleaning device is attached to the connector. When secured, it may engage one or more outer surfaces of the needleless connector. The second (lower) opening of the inner enclosure is such that the threaded valve portion of the unwanted connector is sealed and / or cleaned for insertion into the sealing and cleaning device of the present invention. It is a size that enables. The inner wall of the central bore of the inner enclosure is located (or otherwise spaced) on the opposite side of one or more thread engagement tabs (or threads), preferably two (or more). (Placed) thread engagement tabs are preferably included near the lower opening. The thread engagement tab is configured to engage, for example, a complementary thread area on the outer surface of the needleless connector, whereby the sealing and cleaning device is a thread tab on the interior of the central bore of the inner enclosure. Or through the association of the thread with a complementary thread on the thread portion of the needleless connector, tightly on the target thread portion of the needleless connector for sealing and, if desired, cleaning. Can be screwed in (or otherwise detachably connected to it).

In some preferred embodiments, the outer surface of the inner enclosure is one or more complementary structures on the inner surface of the sidewalls of the outer enclosure (eg, circumferential flanges (or spaced flanges) or other suitable. An outer side including a circumferential flange (or a spaced flange part) that allows the inner case to be held inside the outer case through an association with the outer case. Includes housing holding area. Preferably, such a configuration of the complementary retainer also provides a smooth, low friction transfer (ie,) of the inner and outer enclosures to each other during certain operations, eg, disinfection of the needleless connector. , Rotation) is possible. In some of these embodiments, the retainer of the inner enclosure applies, for example, sufficient force to the outer enclosure for the user to press or otherwise deform the outer enclosure. Allows the engagement area on the inner surface of the outer housing to engage with the corresponding engagement area on the outer surface of the inner housing, allowing the inner and outer housings to rotate in unison. (Eg, as it happens when the user attaches the device to the NC or removes the device from the NC), it can be mechanically engaged with the adjacent area on the inner surface of the side wall of the outer housing. In some of these embodiments, the holding portion (s) of the inner enclosure is adjacent to it as an engaging portion having complementary regions, features, or structures on the inner surface of the sidewall of the outer enclosure. , Or otherwise it can be useful in close proximity to it. In other embodiments, the outer surface of the inner enclosure is one or more outer casings designed to be associated with one or more inner enclosure engagement portions or regions located on the inner or inner surface of the outer enclosure. Further includes a body engagement portion or area. Examples of such members include, for example, a circle of separated teeth or members such as teeth that project from the outer surface of the internal containment and are positioned below the outer housing holding area (eg, circumferential flange). Circumferential bands are included and these teeth (or other suitable engagement structures) are engaged by a complementary structure arrayed on the inner surface of the outer enclosure when the containment is assembled into a functional subassembly. be able to.

In another preferred embodiment, the upper outer surface of the inner enclosure is mechanically engaged with a complementary structure (eg, a claw or other suitable engagement portion) on the inner surface of the upper portion of the outer enclosure. Includes an outer housing engagement area containing one or more structures that allow the outer and inner housings to be in close proximity to the outer and inner housings. The engaging portions engage, allowing the outer and inner enclosures to rotate simultaneously. Certain preferred embodiments of the outer housing engagement structure include separated teeth (or other suitable engagement portions) arranged on the top or top surface of the preferably cylindrical side wall of the inner housing. As will be appreciated, when such inner housing engaging portions and outer housing engaging portions are disengaged or disengaged, the user can use, for example, a needleless connector to which the device of the invention is attached. The outer enclosure can be rotated or rotated relative to the inner enclosure as is done during a cleaning or disinfection operation. Therefore, when the sealing and cleaning device is secured to the needleless connector, such engaging parts are not functionally associated (or not fitted or otherwise engaged). If so, the user can rotate the outer enclosure (and the compressible wash matrix) with respect to the inner enclosure and the connected needleless connector. On the other hand, if the inner surface of the top of the outer housing and the complementary members on the upper surface of the top of the inner housing are engaged (totally or even partially), for example, the user exerts downward pressure on the device. If the device is placed on the needleless connector or the device is removed from the needleless connector, the inner and outer enclosures rotate together and, for example, a sealing and cleaning device is attached to the NC. Allows it to be removed or removed from the NC.

In some preferred embodiments, the inner enclosure is also configured to provide a fluid-sealed sealant between the sealing and cleaning device of the present invention and a needleless connector connected thereto. Including members. In some embodiments, the NC encapsulant is an O-ring (or equivalent encapsulant), preferably in close proximity to the second (lower) opening, typically screwing. Under the combined tab (s), it is placed within a channel formed on the inner surface of the wall of the inner enclosure.

The apparatus of the present invention can also rotate the outer enclosure with respect to the inner enclosure (preferably around its central axis) under certain conditions when the apparatus is attached to a needleless connector. As such, it includes an outer housing adapted or configured to hold the inner housing therein. Using a facing or complementary mechanical or structural feature on the facing or a suitable form of a member, the device provides needleless connector to hold the inner housing within the main cavity of the outer housing. To allow the outer enclosure to rotate relative to the inner enclosure if attached and the user wishes to clean the corresponding surface of the NC using the sealing and cleaning equipment of the present invention. It is possible to engage and disengage the outer housing from the inner housing.

In some embodiments, when the device of the invention is attached to a needleless connector, the inner and outer enclosures rotate the outer enclosure with respect to each other and the user with respect to the inner enclosure. Adopt an outer housing, neutral or rotating configuration so that the cleaning operation can be performed on the valve portion of the NC to which the is attached. Such disengagement, neutral, or rotational configurations can be achieved by any suitable approach, which, under certain conditions, eg, the outer enclosure is pulled up by the user relative to the inner enclosure. When pressed, pushed down, or squeezed, they engage with each other; otherwise, the engagement remains disengaged, which is the outside relative to the inner enclosure when the device is secured to the NC. Includes providing a complementary engagement or structure on the adjacent surface of the inner enclosure that allows rotation of the enclosure. Features that allow transitions between engaging and disengaging positions include springs or urging or elastic elements or materials. In another embodiment, when the device is attached to a needleless connector, the inner and outer enclosures disengage the engagement and thus the outer enclosure rotates independently of the inner enclosure. Adopt an engagement configuration with each other so that they rotate in unison unless the user applies sufficient force to the outer housing to enable.

The outer enclosure accepts the inner enclosure, if desired, and if desired, using one or more features or elements that allow the outer enclosure to rotate relative to the inner enclosure. Includes a cylindrical cavity designed to hold. The cavity is formed by a curved outer side wall, which in some embodiments is joined to the top of the enclosure around its perimeter and is also preferably concentric central matrix wells or matrix mounting areas. Has, or is attached to it, or otherwise associated with a compressible wash matrix, but in some embodiments, to some extent between the matrix well and the central axis of rotation of the outer enclosure. Eccentricity may be desired. In some embodiments, the outer enclosure 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 is designed to releasably engage complementary structures within the outer housing engagement area of the top of the inner housing. Includes inner housing engagement or structure (eg, teeth). By engaging the inner housing engagement structure of the outer housing with that within the outer housing engaging area of the inner housing, for example, the inner housing of the cap and cleaning device is cleaned and / or capped. The user can rotate the outer and inner enclosures simultaneously when screwed into the threaded portion of the needleless connector. When the device is releasably secured to the needleless connector via the inner enclosure, the inner enclosure engagement or structure of the outer enclosure is, for example, by the urging action or elasticity of a compressible cleaning matrix. It can be disengaged (or disengaged) from the outer housing engagement portion of the inner housing, thereby allowing the user to rotate the outer housing around its central axis with respect to the inner housing. enable. A representative example of such an engagement structure is shown in U.S. Patent Publication No. 2018/0304067, but the outer housing allows contact with the surface of the needleless connector when the former is connected to the latter. Features such as an inner enclosure with an opening at the apex are also envisioned to allow the compressible cleaning matrix attached to the inner surface of the apex to extend into the bore of the inner enclosure.

In some of these embodiments, the outer enclosure is one or more vents that allow fluid and / or air to escape from inside the device when the sealing and cleaning device is secured to the needleless connector. A mouth can be included, while in other embodiments no vent is provided. In embodiments with one or more vents, a membrane, filter, or other permeable or semi-permeable barrier is used to allow unidirectional or bidirectional flow of air, gas, or vapor through the vents. Although it is possible, it is possible to prevent microorganisms (eg, bacteria, fungi, viruses, etc.) from moving into the sealing and cleaning device of the present invention.

In certain preferred embodiments, the outer surface of the outer enclosure of the sealing and cleaning device according to the invention comprises one or more grip reinforced structures (eg, multiple vertical ridges) or coatings. Such a grip-enhanced structure or coating makes it easier for the user to grasp the containment of the sealing and cleaning device between the fingers, not only during the insertion and removal of the needleless connector from the cap cleaning device. It can also be useful during the cleaning process, in which case the user rotates the outer housing relative to the inner housing to expose the surface of the inserted needleless connector with the device's compressible cleaning matrix. Rubbing, thereby cleaning or cleaning.

In some embodiments, the apparatus of the invention comprises one or more elements or features arranged on facing surfaces of the inner and outer enclosures, whereby the user is fitted with the device. It is possible to sense that the outer housing is rotating with respect to the inner housing in order to give a cleaning action on the valve surface of the NC. Such sensory feedback can include one or more of auditory, tactile, and / or visual stimuli generated from the device by rotation of the outer enclosure with respect to the inner enclosure.

In some of these embodiments, the device of the invention is an elastic inner body that is located within the cap and can rotate or rotate with respect to the cap when the cap and cleaning device are secured to a needleless connector. It comprises a compressible matrix portion comprising one or more antibacterial reagents and having a structure that allows the capped surface of the needleless connector to be cleaned. More specifically, the elastic inner body forms a central internal (preferably cylindrical) bore extending between the first and second (each or above) openings located opposite each other. Has a wall to do. The inner wall of the central bore closer to the second (lower) opening preferably contains two thread engagement tabs (or threads) that are located opposite each other. The thread engagement tab is configured to engage, for example, a complementary thread area on the outer surface of a needleless medical valve. This allows the cap and cleaning device to be securely screwed into the target threaded portion of the needleless connector for cleaning and, if desired, capped to that portion of the needleless connector. The outer surface of the elastic inner body contains one or more structures that allow mechanical engagement and disengagement with complementary structures located on the inner surface of the cap.

In many embodiments, the outer surface of the elastic inner body is a spaced convex (eg, for example) that allows the elastic inner body to mechanically engage and disengage with a complementary engaging structure on the inner surface of the cap. Includes a cap engagement area containing one or more structures such as teeth). A preferred embodiment of the cap engagement structure comprises alternating teeth and grooves (or channels) arranged around the outer perimeter of the elastic inner body, the teeth and grooves arranged on the inner surface of the outer wall of the cap. Complementary to one or more spaced engagement structures (eg, teeth). In another embodiment, the cap engagement region of the elastic inner body is to engage with one or more complementary engagement structures (eg, teeth) arranged on the outer surface or outer surface of the matrix well wall. It is 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 elastic inner body also contains a compressible region. In many preferred embodiments, it is located above the threaded engagement tabs (s) and cap engagement area. The compressible region allows the elastic inner body to be compressed so that the first and second openings are close to each other to allow disengagement of the engagement structure between 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 preferably plastic or other fully flexible as part of an elastic inner body, preferably during injection molding. A molded torsion spring made of an elastic material.

In some embodiments, the elastic inner body is made up of two or more parts that are then assembled to form the finished inner body. For example, the elastic inner body can be formed as two or more separate parts assembled up and down during the manufacture of the sealing and cleaning device of the present invention. For example, in embodiments where the elastic inner body is made up of two parts, the top preferably comprises a compressible region (eg, a screw spring formed during injection molding of the top), while the bottom is a cap. Includes engagement area and thread engagement tab (s). In contrast, a three-part representative embodiment of an elastic inner body consists of an upper section containing a first (upper) opening and a compressible area, an intermediate section containing a cap engagement area, and a screw. Includes engagement tabs (s) and a lower section containing a second (lower) opening. In an alternative three-part embodiment, the upper portion comprises a first (upper) opening and cap engagement region, the middle portion comprises a compressible region, and the lower portion is a threaded engagement tab (singular or). Includes multiple) and second (lower) openings. As will be appreciated, the invention includes all possible combinations of components having a cap engagement area, a compressible area, and an area that engages the threaded portion of the threaded portion of the needleless connector, and as a result, When the final combination is compressed and the cap and the corresponding structure on the inner body are engaged, the cap and inner body can rotate together around their central axis, on the cap and inner body. When the corresponding structure of is disengaged by compression of the compressible region, the user can rotate the cap around its central axis, or independently of the elastic inner body (ie, the elastic inner body). (The cap spins while it is not engaged), demonstrating that the elastic inner body can be rotated so that it does not engage or independently.

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

In some preferred embodiments, the inner enclosure or elastic inner body is also a sealing member configured to provide a fluid sealed seal between the sealing and cleaning device of the invention and the NC connected thereto. Includes (ie, encapsulant). The encapsulation is preferably in a channel formed on the inner surface of the wall of the elastic inner body close to the second (lower) opening, typically screw engagement tabs (s). Placed under.

Each device of the invention also includes an inner enclosure such as an elastic inner body and an outer enclosure or cap operably associated with it. The cap typically has an outer cavity formed by a curved outer wall joined to the apex, preferably around the perimeter of the apex, and a preferably concentric central matrix well extending from the inner surface of the apex into the outer cavity. including. The walls forming the matrix wells are located away from the outer wall of the cap and form an elastic member containment accessible through an opening created by the gap between the walls of the cap and the walls of the matrix wells. In many preferred embodiments, the inner surface of the outer wall of the cap is one or more engagement or locking structures designed to releasably engage with complementary structures within the cap engagement area of the elastic inner body (eg,). , Teeth) (ie, the corresponding structure can be engaged and disengaged, if desired). In other embodiments, the cap engagement or locking structure is placed on the outer surface of the matrix well wall, which locking structure is releasable with complementary structures within the cap engagement area on the inner wall of the elastic inner body. Designed to engage. By engaging the cap engagement or locking structure with what is in the cap engagement area of the elastic inner body, the user can, for example, screw a needleless connector into which the cap and cleaning cap are cleaned and / or capped. The cap and elastic inner body can be rotated simultaneously when screwed into the portion. Once the device is removably secured to the needleless connector, the locking structure of the cap can be disengaged from within the cap engagement area of the elastic inner body, whereby the user can with respect to the elastic inner body. The cap can be rotated around its central axis. In some embodiments, the cap may include one or more vents that allow fluid and / or air to escape from inside the device when the cap and cleaning device are secured to the needleless connector. However, in other embodiments, vents are not provided.

The sealing and cleaning device of the present invention also includes a compressible cleaning matrix in the matrix wells of the outer enclosure. The compressible wash matrix may be, for example, open cell foam. The cleaning matrix is preferably secured to the inner surface of the outer housing so as to limit or limit its rotation independently of the outer housing during the rotation of the outer housing. The compressible cleaning matrix is configured to contact and clean one or more surfaces of the needleless connector that comes into contact with the matrix during the association of the needleless connector with the sealing and cleaning equipment of the present invention. The compressible wash matrix attached to or otherwise associated with the outer enclosure compresses axially (ie, along the central axis of the matrix wells of the outer enclosure when the needleless connector is inserted into the sealing and cleaning device. Can be compressed).

The surface of the needleless connector to be cleaned is a surface-attached microorganism that allows biofilms (ie, microorganisms, typically bacteria and / or fungi, to adhere to the surface and carry out specific biochemical processes. And since it can be contaminated with microorganisms that form the matrix of extracellular material), the compressible wash matrix preferably has sufficient mechanical integrity when compressed and is not contacted by the wash matrix. Allows its use to destroy any biofilm that may be present on the surface of the needle connector. Biofilm destruction includes, for example, the inner enclosure of the sealing and cleaning device (eg, the elastic inner body) and the needleless connector to which the inner enclosure is detachably attached, while the outer enclosure (compressible cleaning matrix). Whether to rotate the next compressed wash matrix relative to the needleless connector (eg, needleless medical valve) by rotating the attached, otherwise associated, or held) It can be caused by twisting, or otherwise moving. The friction that occurs between the compressed wash matrix and the surface of the needleless connector destroys the biofilm, thereby cleaning and preferably sterilizing the needleless connector. After such cleaning, if the sealing and cleaning device is left fixed (ie, sealed) to the needleless connector, the biofilm regrowth and / or the cleaned surface of the needleless connector (compressible cleaning matrix). Microbial recolonization (which remains in contact with) is restricted and preferably hindered.

In a preferred embodiment, the compressible wash matrix preferably comprises one or more wash reagent species dispersed therein at the time the device is manufactured, whereas in some embodiments the wash reagent is. The matrix may be dispersed in the matrix just before it contacts the needleless connector. In the latter type of embodiment, the cleaning reagent is preferably housed within the body of a sealing and cleaning device in a reservoir configured to rupture upon coupling of a needleless connector for cleaning. Such reservoirs can be placed between the matrix and the needleless connector, or more preferably between the rotatable cap and the compressible wash matrix. Preferred cleaning reagents include antibacterial reagents such as isopropyl alcohol, chlorhexidine, and silver ions. In some embodiments, the sealing and cleaning apparatus of the present invention includes a valve or opening that allows the liquid in the cleaning reagent to evaporate.

In some preferred embodiments, the compressible wash matrix is composed of two or more components. In some of such embodiments, one portion of the matrix is attached to the inner surface of the outer housing and the other portion is secured to the inner surface of the wall forming the matrix well. If present, a portion of the compressible wash matrix secured to the inner surface of the matrix well wall is preferably configured to compress radially in association with the needleless connector to be capped and washed. If the wash matrix is composed of two or more components, the matrix components can be made from the same different material.

As mentioned above, the central matrix well is adapted to accept a compressible wash matrix. The surface of the central matrix, which is in good contact with the matrix, is preferably disengaged so that, in particular, the cap engagement structure and elastic inner body allow rotation of the cap during the needleless connector cleaning procedure. Includes one or more holding structures to hold the compressible wash matrix so that its rotation or movement is linked to the rotation or movement of the cap, if done. Such retention structures include ridges and other protrusions from the surface of the central matrix that are in good contact with the compressible wash matrix. Adhesives can also be used to glue that portion of the compressible wash matrix to the desired location within the matrix well.

In various embodiments, the outer surface of the outer enclosure of the sealing and cleaning device according to the invention comprises one or more grip-enhanced structures or coatings, eg, a plurality of vertical ridges. Such a grip-enhanced structure or coating makes it easier for the user to grasp the body of the sealing and cleaning device between the fingers, not only during the insertion and removal of the needleless connector from the cap cleaning device. The user can also rotate the outer enclosure relative to the inner enclosure and rub the surface of the inserted needleless connector with a compressible cleaning matrix, thereby helping during the cleaning / cleaning process. ..

The inner and outer enclosures can be made from any suitable material or a combination of different materials. Plastic is particularly preferred. The material used to make the outer housing may be the same as or different from the material used to make the inner housing.

The outer housing and its various components are preferably formed as a single integral unit during manufacturing (eg, by injection molding). The inner and outer enclosures 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. With the inner and outer enclosures as a functional subassembly that can be transitioned between engaging and disengaging configurations to provide single or independent rotation of the outer enclosure with respect to the inner enclosure. Any suitable holding structure or group of structures can be used to provide movement, i.e., rotation of the outer housing relative to the inner housing to secure them together. Such structures include mounting mechanisms such as "snap-fitting" mechanisms where the interacting parts are flexible enough and preferably have tapered surfaces to facilitate assembly.

The compressible wash matrix can be placed in the matrix well after the inner and outer enclosures are operably associated. In a preferred embodiment, using a suitable adhesive, a compressible cleaning matrix, or if the matrix contains more than one component, its various parts, one of the matrix wells of the outer enclosure. Firmly adheres to the above inner surface. In some embodiments, the surface of the matrix well in contact with the compressible matrix comprises a structure that assists in retaining the matrix within the well, thus rotating the outer enclosure during the cleaning procedure. And ensure that it moves in connection with the cap.

In a preferred embodiment, the sealing and cleaning device comprises a removable lid or seal attached to the outer enclosure to seal the device, thus separating the interior space and structure of the device from the external environment. .. Such lids or seals are placed inside the device, including the internal enclosure and compressible cleaning matrix, by a healthcare professional just prior to the use of the seal, typically the cap and cleaning device, on the cap. It is removed and, if necessary, prevented from being exposed to the environment until the needleless connector to which it is connected (eg, a needleless medical valve) is cleaned / cleaned. In a preferred embodiment, such cleaning substantially destroys any biofilm that may be present on the surface contacted by the compressible cleaning matrix. If desired, the sealing and cleaning device is in place (typically after cleaning the needleless connector attached to it) to cap the needleless connector until the needleless connector is further accessed. It can be left behind, thereby minimizing the exposure of the capped outer surface of the connector to potential pathogen contamination (and biofilm formation) from the surrounding environment. The sealant is typically attached during the manufacture of the sealing and cleaning equipment of the present invention. In embodiments where the cap and cleaning device are sterilized during production (eg, by irradiation, exposure to ethylene oxide, etc.), it is preferred to apply the encapsulant prior to sterilization.

Another aspect of the invention relates to a method of cleaning and / or sealing a needleless connector using the sealing and cleaning apparatus according to the invention. Such methods typically allow the outer housing to spin or rotate with respect to the inner housing so that the inner and outer housings are typically connected after the device is connected to a needleless connector. Includes transitioning the body from an engaging configuration to a disengaging configuration. Such compression facilitates contact between the compressible wash matrix of the device and the associated surface of the needleless connector. The spin or rotation of the outer enclosure with respect to the inner enclosure, and the associated surfaces of the needleless connector allow these surfaces to be rubbed, thereby cleaning them. Preferably, such a cleaning method provides 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 wash matrix comprises one or more antibacterial reagents, the microorganisms and pathogens present in and / or on such surfaces in such biofilms are destroyed or incapacitated. Be made.

As used herein, the compressible cleaning matrix of the sealing and cleaning equipment of the present invention comprises one or more cleaning reagent species dispersed in a substrate. The cleaning matrix substrate allows effective friction-based cleaning of the site or portion of the needleless connector, including the top surface, sides, and any threads or grooves of the site, if present. It can be any material that can be adapted, molded, or compressed in a manner that provides a cleaning reagent, at least at the surface level. Examples of compressible cleaning matrices include open or closed cell foams such as cotton, polyethylene foam, or other substances capable of retaining or carrying cleaning reagents.

In some embodiments, the wash reagent species are dispersed in a compressible wash matrix during the process used to make the seal and wash device, or otherwise compressible wash. Combined with the matrix, while in other embodiments, the instrument is released for dispersion of the cleaning reagent into a compressible cleaning matrix after manufacture, but the matrix contacts the needleless connector to be cleaned. It is configured to be released when or before. The cleaning reagent can be any chemical, substance, or material that cleans sites such as bacterial or viral microorganisms, biofilms, or any carrier that contains such chemical, substance, or material. Examples of cleaning reagents include isopropyl alcohol, 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 present invention, the cleaning reagent contains an active ingredient capable of cleaning the surface of a needleless connector. Any active ingredient that can be effectively used to quickly clean medical fittings or medical line connectors (eg, needleless connectors) can be adapted for use in carrying out the invention, and Generally classified as antibacterial and / or antibacterial reagents, disinfectants or antibacterial reagents, broad disinfectants, and / or parasite repellents, and combinations of such reagents. Biocompatible cleaning reagents are particularly preferred as the devices of the invention are intended for human and / or veterinary use, 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, suitable solutions, suspensions, or emulsions. Dissolved or dispersed in. Other active ingredients with appropriate cleaning effects can also be used. These are alcohols (eg, ethanol, benzyl alcohol, isopropyl alcohol, phenoxyethanol, phenethyl alcohol, etc.); antibiotics (eg, aminoglycosides (eg, amicacin, apramycin, canamycin, neomycin, netylmycin, paromomycin, streptomycin, and tobramycin); Bacitracin; erythromycin; tetracycline; quinolone (eg, oxolinic acid, norfloxacin, nalidixic acid, pefoxacin, enoxacin, and ciprofloxacin); penicillin (eg, oxacillin and pipla encapsulant); nonoxynol 9; fusidic acid; cephalosporin Etc.). Quartic ammonium chloride, quaternary ammonium chloride, chlorinated phenol, fatty acid monoesters of glycerin and propylene glycol, iodine-containing compounds (3-iodo-2-propynylbutylcarbamate (IPBC), etc.), iodophore (active ingredient of providin iodine) 100%), Hydantin (dimethyl hydantine and halogenated hydantin, etc.), Paraben (methylparaben, ethylparaben, propylparaben, etc.), chloroxylene and its salts; Chlorhexidine hydrochloride; Chlorhexidine sulfate; benzoic acid and its salts; benzethonium chloride; methylbenzethonium chloride; chlorobutanol; sorbic acid and its salts; buttocoazole nitrate; maphenide acetate; nitromerzole; triclocarban; phenylmercuric nitrate or acetate (0.002%); Chlorocresol; Clindamycin; CAE (Anzinomoto) DL-pyrrolidone carboxylate of L-cocoyl arginine ethyl ester; 0.2%, 0.02% and 0.002% concentrations of cetylpyridinium chloride (CPC); 9.8% Isopropyl alcohol; 1% ZnEDTA; mupyrosine; and polymixin (polymixin b-basitrasin sulfate). In addition, other beneficial compounds and compositions include miconazole, econazole, ketoconazole, oxyconazole, haloprogine, clotrimazole, butenafine HCl, naftifine, riphanpicin, terbinafine, ciclopirox, tornafutate, lindan, lami-encapsulated, etc. Examples include fluconazole, amphotericin B, cyprofloxesin, octenidin, triclosan (2,4,4'-trichloro-2'-hydroxydiphenyl ether), microvan (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 sulfaziazine. Examples include silver and its salts, including. Cleaning reagents are often compositions containing the desired active ingredient 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 used to form the outer housing, inner housing, and other components of the particular device. Material and compatibility. In some embodiments, the wash reagent is dispersed in a compressible wash matrix after the matrix has been formed. For example, the cleaning reagents can be dispersed by saturated or supersaturating the compressible cleaning matrix during the manufacture of the appliance, preferably prior to sealing. In other embodiments, the cleaning reagents may be dispersed during the process used to produce a compressible cleaning matrix. As will be appreciated, the materials used to prepare the cleaning reagents do not perceptibly degrade the substrate before being used to clean needleless connectors (eg, needleless medical valves). Or it should be compatible with one or more components, including a compressible wash matrix, so as not to suffer a loss of structural integrity otherwise. Similarly, cleaning reagents are needleless medical, as are materials used to prevent harm to the patient in case of contact or to form needleless medical valves (or other needleless connectors). It should be biocompatible so that a certain amount of cleaning reagent can be placed in the fluid carrier portion of the valve.

In a preferred embodiment, the material used to form the compressible wash matrix can be wetted and / or impregnated with a wash reagent and engages, for example, on contact with a needleless medical valve to be washed. Any suitable absorbent, flexible, flexible, elastic, fibrous that can be easily and easily adapted to complex surface contours that are likely to be complex (eg, luer threads, concave and convex, flanges, etc.) , Or a porous material, or a combination of materials. Such materials include compositions or naturally occurring ones, which may have a homogeneous or heterogeneous composition. Preferred synthetic materials include fibrous, foam (eg, felt foam), and gel compositions, in particular those having directionally oriented natural or synthetic fibers, or a combination thereof. Preferred natural materials useful as substrates include plant-derived materials such as cotton and paper products, as well as fibrous natural materials, including animal-based textile products such as wool. Another preferred natural material is sponge.

As will be appreciated, in order to achieve the desired cleaning effect, a compressible cleaning matrix, or its component designed to contact a needleless connector such as a needleless medical valve, is preferably cleaned. Parts on the surface of needleless connectors such as needleless valves or luer access devices, especially surfaces that are exposed to air and therefore at risk of contamination with infectious or pathogenic reagents, and biofilms containing them. Part of the fluid flow path for fluids made from materials (or combinations of materials) that allow complete cleaning and also introduced into the patient, such as IV solutions, drugs, blood and blood products. Is also intended to form.

Preferably, the material used to make the compressible wash matrix is usually to allow the compressible wash matrix to adapt to the external structure present on the surface of the needleless connector to be cleaned. It should be flexible enough to allow it to deform under the pressure experienced during use. This ensures close cleaning contact between the compressible cleaning matrix and at least their exposed surfaces of needleless connectors designed to contact fluid entering the valve, such as IV fluids. .. In addition, the compressible wash matrix preferably allows the liquid wash reagent to be retained within the void volume of, for example, in the capillary space, foam, sponge, etc. The compressible wash matrix may also be engineered to include wash reagents such as silver ions and / or other suitable materials.

Preferred natural materials capable of forming a compressible wash matrix include those derived from cotton and naturally occurring sponges. As those skilled in the art will understand, processed cotton fibers are almost entirely composed of natural polymeric cellulose. In such fibers, 20-30 layers of cellulose are coiled into a series of spring configurations, which make the fibers absorbent and give them a high degree of durability and strength. For example, a woven cotton sheet such as that often used in the manufacture of sterile cleaning pads saturated with 70% isopropyl alcohol (IPA) solution can be used as a substrate for the cleaning elements according to the invention. Suitable forms can be used. For example, a woven cotton sheet can be cut into a large number of similarly sized pieces, each of which can be used as a substrate. In many embodiments, after attachment to the inner surface of the layer of the container (eg, via the use of adhesives, double-sided tape, tape, etc.), the matrix is ready for the addition of suitable cleaning reagents. Alternatively, cotton fibers can be spun onto the inner surface of the cap. Other fibers with similar properties are natural, synthetic, or a combination of natural and synthetic materials and can be easily adapted for use as a compressible cleaning matrix.

Another class of material for the production of compressible wash matrices is directional oriented fiber material. These include, but are not limited to, materials consisting of cellulose fibers, glass fibers, and polyester fibers, as well as materials consisting of two or more combinations of these and / or other materials. Such bound synthetic fibers use capillary action to accurately absorb, retain, move, and / or release the liquid or vapor in the desired amount. Fibers can be formed using a wide range of synthetic polymers, and if desired, they can be treated for functional purposes, eg, containing the cleaning reagents dispersed therein, of the product. A vapor barrier or other coating that covers a portion of the surface can be provided and the like. Also, the geometry of these materials can be customized for specific applications, thereby making it easy to integrate into substrate configurations with the desired device thickness, width, length, diameter, etc. Enables.

Other representative classes of materials suitable for use as compressible cleaning matrices include gel-forming polymers and foams (eg, agarose, agar, polyacrylamide, and layers, sheets suitable for the practice of the present invention. , Columns, or other synthetic porous materials that can be formed into other shapes). Typical gelatinous materials include hydrogels (ie, crosslinked polymers that absorb and retain water), in particular those made from agarose, (2-hydroxyethyl) methacrylate and its derivatives, and synthetic carbohydrate acrylamide. Is done.

Yet other types of materials include porous polymer sponges. Such sponges can be formed from any suitable material, including polyethylene, polypropylene, polytetrafluoroethylene, polybinylidinedifluoride, polynitrile, and polystyrene. Many such porous polymer sponges are commercially available in a wide variety of shapes, pore densities and sizes. Further, the polymer sponge can be produced by polymerizing a suitable monomer according to a conventional foam forming technique. In general, sponges have an open pore structure to allow the transfer of solvents such as liquid cleaning reagents. The sponge surface should contain openings to provide entry of liquid cleaning reagents (eg, alcohol, iodine-containing solutions, etc.) and, like any other material used to form the matrix, is selected. Certain materials are preferably inert, i.e., do not react with the components of the cleaning reagents, the body of the sealing and cleaning equipment, or the materials used to make needleless connectors such as needleless medical valves. ..

Surgical foam is another preferred type of material that can be used to make a compressible wash matrix. The material can be natural or synthetic, if 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 of the preferred foam materials is Microbisan ™ (Lendell Manufacturing, St. Charles, MI), a hydrophilic polyurethane foam impregnated with silver ions. Preferably, such foams are highly absorbent and are therefore suitable for use with liquid cleaning reagents. In other embodiments, the material used to form the foam is well suited for dispersion of dry cleaning reagents such as silver ions. Again, the foam material is preferably inert when used as a substrate. Also, they are preferably given a large number of medical valve shapes, sizes, and configurations, and various different shapes and surface configurations encountered in the art (eg, double-sealed fluid access points, luer threads). It is flexible enough to fit (mountains, etc.). In this way, sufficient contact can be ensured between the cleaning surface of the sealing and cleaning device and the surface of the needleless connector to be cleaned. Another advantage of some synthetic foams (as well as certain other polymeric materials from which a substrate can be formed) can be easily injected into the shell or enclosure in the desired volume during manufacture, after which they expand. The desired substrate size, density, porosity, etc. are exhibited.

In addition, the compressible wash matrix indicates, for example, a change from wet to dry state using a color change, or instead, the matrix material is immediately before use, as opposed to during the manufacture of the device. Can contain chemicals that exhibit functional changes in the substrate by being properly moistened with a liquid cleaning reagent dispersed by a healthcare professional. Therefore, depending on the system used, the color change of the matrix can be used to indicate that the cleaning reagents in the compressible cleaning matrix have evaporated before use, and thus perhaps of the sealing and cleaning equipment. No particular cleaning device should be used due to leaks in the storage vessel. Alternatively, for example, when a colored liquid cleaning reagent is used, the user may visually confirm the dispersion of the reagent in the matrix by assessing whether the colored cleaning reagent is dispersed throughout the matrix. can. When a colored cleaning reagent is used, the material is an elastic inner body of the sealing and cleaning device and / or to allow easy visualization of any color change before or during use of the sealing and cleaning device. Used to make the cap transparent or translucent, or preferably include one or more transparent or translucent windows.

The caps and cleaning devices of the present invention, as well as their components (eg, elastic inner bodies, caps, compressible cleaning matrices, encapsulation rings, encapsulants, etc.) are made from any suitable material and can be of any suitable material. It can be assembled using the appropriate process.

Preferably, the outer surface of the outer enclosure of the sealing and cleaning device intended to be gripped by the user is a non-slip surface, i.e., the outer portion of the sealing and cleaning device is held by the user's finger and is a needleless connector. When placed to wash, the outer enclosure is rotated relative to the inner enclosure and needleless connector, minimizing slippage (with or without gloves) between the device and the user's fingers. Have one with a high coefficient of friction so that it can be with or without gloves (with or without gloves). Examples of such non-slip (or high friction) surfaces include ridges, valleys, depressions, ridges, or other features designed to increase friction, as well as two or more combinations of such features. Includes what you have. Such features can be introduced on the outer surface of the device as part of the manufacturing process. Alternatively, the non-slip coating may be applied to one or more of the outer surfaces of the outer enclosure.

Generally, the sealing and cleaning device of the present invention is provided to the user in a sealed and sterile state. If desired, can labeling information, logos, artwork, manufacturing, and / or regulatory data (eg, lot number, expiration date, or "expiration date") also be printed on individual sealing and cleaning equipment? , Or otherwise applicable. In addition, information such as barcodes (eg, to allow the use of tracked equipment) may also be included in the individual sealing and cleaning equipment.

As will be appreciated, the cleaning equipment may be packaged as a kit individually or in groups of two or more units, and the kit may include instructions for sealing and cleaning equipment, as well as other information, logos, etc. It 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 a particularly preferred practice, the sealing and cleaning equipment of the present invention is sterilized as part of the manufacturing process. Here, "sterilization" effectively kills or eliminates transmissible reagents (eg, bacteria, viruses, fungi, prions, spores, etc.) that may be present in any component of the apparatus according to the invention. Refers to any process. In a preferred embodiment, sterilization can be achieved by heating, chemical treatment, irradiation, and other processes. In fact, any sterility process compatible with the materials used to make the sealing and cleaning equipment can be used. A particularly preferable sterilization treatment is an irradiation treatment. Such processes include irradiation with X-rays, gamma rays, or subatomic particles (eg, electron beams). Generally, when sterility treatment is used in the context of the present invention, this treatment is used for cleaning articles after sealing and / or packaging. Chemical sterilization treatments, such as sterilization using ethylene oxide (EtO), can also be used.

The present invention also relates to a method of using the disposable sealing and cleaning apparatus of the present invention of the present invention. Such methods include using the device to clean and cap the needleless connectors, such as needleless connectors, luer access devices, etc., if desired. To perform such a method, the portion of the needleless connector that is cleaned is typically a sealing and cleaning device after the user (eg, a nurse) has removed the seal over the opening of the device. Screwed into the central bore of the inner housing. Such insertion brings the site of the needleless connector into contact with (ie, wash-bonds) the compressible wash matrix portion of the device. In a preferred practice, when the compressible wash matrix comes into contact with the surface of the needleless connector to be cleaned, the outer enclosure automatically disengages the engaging portions in the inner and outer enclosures and the inner casing. Allows rotation of the outer enclosure with respect to the body, allowing a needleless connector pre-sealed and releasably connected to the cleaning device. Such contact and cleaning action can be any desired period, with a period of about 1 second to about 10-20 seconds particularly preferred.

After cleaning, the needleless connector can be removed from the sealing and cleaning device and then the sealing and cleaning device can be discarded. Alternatively, after cleaning, the sealing and cleaning device may remain attached to the needleless connector, sealing a portion thereof, sealing it, and then until access to the needleless connector is desired. Protect from pollution. At that point, the sealing and cleaning device can be removed and disposed of. If desired, the cleaning process can be repeated immediately prior to removal.

Immediately connect a medical reservoir containing fluid (eg, a syringe containing a drug, an IV bag, etc.) to the cleaned needleless connector after removing the sealing and cleaning device from the cleaned needleless connector. Can be done. In a preferred embodiment where the cleaning reagent is a solution, the surface of the needleless connector is preferably dried (or wiped with, for example, a sterile absorbent cloth or wipe) before connecting the needleless connector to the fluid reservoir. Can be dried) (or dried), and this cloth or wipe can be dried or moistened with a volatile compatible solution such as 70-100% alcohol). In a preferred practice, such cleaning methods result in at least 2-fold, 5-fold, or 10-fold reduction in microbial contamination on the washed accessible surface (s). Even more preferably, the level of reduction may exceed 100-fold, 103-fold, 104-fold, 105-fold, 106-fold, or 107-fold reduction of microbial contamination on accessible fitting surfaces.

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

[Representative Embodiment]
To further illustrate and illustrate specific preferred representative embodiments of the invention, the reader will reference the accompanying drawings, FIGS. 1-10, illustrating various particularly preferred embodiments of the sealing and cleaning apparatus of the present invention. set to target. These preferred representative embodiments will be described below.

FIG. 1 shows some of the typical sealing and cleaning devices (10) of the present invention, their components (Figures (b)-(g)), and devices related to needleless connectors (Figure (a)). The drawings ((a) to (g)) are shown. The component includes a cap having a cap portion (11) adapted to receive and hold the compressible cleaning matrix (80) and an elastic inner body (30) associated with the cap portion (11). So that the cap portion and the elastic inner body move independently of each other under certain conditions, while allowing the cap portion (11) under other conditions to prevent them from moving independently of each other. Fitted to engage with one or more complementary features of the cap portion. For example, after attaching the device (10) to the needleless connector (100) (creating a needleless connector (200) with a cap), the user applies pressure to make the cap (10) into the needleless connector (100). By compressing against it, the elastic inner body (30) of the device (10) can be compressed and the cap (10) can be rotated with respect to the elastic inner body (30) and the needleless connector (100). do. Such an operation brings the compressible wash matrix (80) into contact with the surface of a needleless connector (100) that is desired to be cleaned, for example, the valve surface of a needleless medical valve, and is needleless. The rotation of the cap (10) with respect to the connector (100) creates, for example, a friction that can destroy the biofilm that may be present on the valve surface of the needleless medical valve, which surface is the fluid moving through the medical valve. Can be in the flow path of.

FIG. 2 (a) is an exploded view of a typical sealing and cleaning device (10) and needleless connector (100) of the present invention. Visible is the cap (10), which includes the cap portion (11), in which a compressible cleaning matrix (80) and an elastic inner body (30) are placed, and a lure base, which is a needleless medical valve. Includes a needleless connector (100), the male end (105) of which is a collar (101) and a collar (101) for connecting the valve to the female thread portion of the complementary luer fitting of another needleless connector (not shown). Has a screw (102). FIG. (B) is a cross-sectional side view of the cap (10) shown in FIG. (A) in a state of being sealed with the sealed body (90). As shown, the cap portion (11), the compressible cleaning matrix (80), and the elastic inner body (30) are operably assembled. The compressible wash matrix (80) is preferably formed in the inner surface of the cap portion (11) and placed in a matrix well (12) protruding from it. The height of the matrix well (12) should allow the retention of the compressible wash matrix (80), and in some embodiments it is a needleless connector (100) with the cap compressed by the user. It can be sized to act as a stopper that can be supported against the collar of the needleless connector (100) to which the cap is attached when rotated to clean the desired surface of the.

Figures (c) and (d) of FIG. 2 show the cap (10) screwed into the medical valve (100) in a cap and cleaning configuration (Figures (c) and (d), respectively). As shown in these figures, the compressible wash matrix (80) of the cap (10) presses against the valve surface of the valve stem portion (103) of the medical valve (100). In sealed view, view (c), the cap (and compressible wash matrix (80)) is uncompressed. The diameter of the matrix well (12) is that when the cap is pushed towards the medical valve (100) by a user who wants to clean the surface of the valve stem portion (103), the cap is screwed on the medical valve (100). Allows sliding on the mountain (102). Figure (d) shows a cap (10) compressed against a medical valve (100). User-induced compression brings the cap portion (11) closer to the body of the medical valve (100) by compressing the elastic inner body (30) and the compressible wash matrix (80). This movement also results in the disengagement of the complementary mechanical holdings of the cap portion (11) and the elastic inner body (30), thus allowing the user to disengage the cap portion (11) and the cap's compressive cleaning matrix (80). ) Allows to rotate 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. In figures (a)-(c), the cap portion (11) and the elastic inner body (30) are engaged and the cap (10), and thus the compressible cleaning matrix (80) associated with it, is of the device. Shown is a device (10) in a static, uncompressed, non-rotatable position that cannot rotate with respect to the elastic inner body (30). Figures (d)-(f) show the cap portion (11) and the cap portion (11) so that the cap portion (11) and its associated compressible cleaning matrix (80) can rotate with respect to the elastic inner body (30) of the device. The same typical device (10) in which the elastic inner body (30) is movable is shown. The inner surface of the elastic inner body (30) includes one or more (preferably two) tabs (35) that engage the threads of the needleless connector (100). In the embodiment shown in the figure, the outer surface of the elastic inner body (30) was designed to engage a complementary separation structure (eg, rib (18)) separated on the inner surface of the cap portion (11). Includes multiple teeth (33) or other structures spaced around the outer perimeter of the elastic inner body. When the cap (10) is not compressed, the teeth (33) engage the ribs (18) and effectively lock the cap portion (11) and the elastic inner body (30) together so that they Let it rotate together. This allows the cap (10) to be screwed onto the complementary luer fitting of the needleless connector, for example, using the inner tab (35) of the elastic inner body (30) and sealed. The function (the process is reversed to remove the cap from the needleless connector) is provided. Once secured to the needleless connector to provide cleaning action, the cap (10) can then be compressed by the user, which directs the cap portion (11) towards the fitting of the needleless connector. Press to compress the compressible cleaning matrix (80) against the surface of the connector (100) to be cleaned.

FIG. 4 shows a diagram of a cap portion (11) of a typical sealing and cleaning device (10) of the present invention. FIG. (A) shows a top view of the cap portion (11). Also, on the outer surface portion of the cap portion (11), ridges and valleys that enhance friction are visible, allowing the user to better grip or grip the cap (10). FIG. (B) shows a side view of the cap portion (11). FIG. (C) shows a bottom view of the cap portion (11). In this embodiment, six ribs (or protrusions) (18) arranged at equal intervals (here, about 60 degrees in the center) are visible around the circumference of the inner surface of the cap portion. The rib (18) is positioned and sized to engage complementary features on the outer surface of the elastic inner body (30) (not shown). The walls forming the matrix well (12) can also be seen in this figure. FIG. (D) shows a cross-sectional view of the base portion (11). Wells (20) formed by matrix well walls (12) extending from the inner surface of the top of the cap portion (11) are also shown to accommodate and hold the compressible wash matrix (80). In a preferred embodiment, an adhesive (not shown) or other binding reagent is used to bond the compressible wash matrix (80) inside the wells (20). The well (20) is separated 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 the complementary retainer of the cap portion (11) (eg, ribs (18) and teeth (33)). The cap portion (11) can be rotated around it. In a exemplary embodiment of the sealing and cleaning device (10) of the invention depicted in the drawings, the upper surface (19) of the holding portion (18) present in the cap portion (11) is between the teeth (33). Designed to engage the underside of the lock groove (34).

FIG. 5 shows seven different views ((a)-(g)) of the elastic inner body (30) of a representative sealing and cleaning device (10) of the present invention. Representative measurements of this particular embodiment are shown in some figures. In this embodiment, two thread tabs (35) located on the inner surface of the wall (36) of the elastic inner body (30) are shown, with twelve separated teeth (33) being the cap portion ( Engage with 12 complementary holdings (eg, ribs (18)) on the inner surface of 11). The elastic inner body (30) is designed to be compressed by the user when an appropriate force is applied and rebound when such pressure is released.

FIG. 6 shows five different figures ((a)-(e)), three of which are the compressible cleaning matrix portions (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 wash matrix (80). Preferably, the compressible wash matrix (80) is adhered to the surface of the matrix well (20) of the cap portion (11) with an adhesive. Figures (d) and (e) of FIG. 6 show a bottom view and a side view of a sealing portion (90) of a typical sealing and cleaning device of the present invention. The sealant (90) is typically sized to seal or cover an opening that allows access to the interior of the cap (10). Preferably, the encapsulant allows the user to grip so that the encapsulant can be removed just before the device is used to cap and / or clean the needleless connector (100). Includes one or more configured removal tabs (91). Preferably, the encapsulant is adhered to the cap (10) with a suitable adhesive (94) applied to the inner surface (92) of the encapsulant (90). The outer surface (93) of the enclosure often contains alphanumericals, bar code information, and the like.

FIG. 7 (FIGS. 7A-7E) show five different views of another representative sealing and cleaning device (300) of the invention, where the user squeezes (or squeezes) the outer enclosure (301). By applying pressure using two or more fingers), the inner housing (320) and the outer housing (301) are engaged, the outer housing (301) is slightly deformed, and the outer housing (301) is slightly deformed. The inner casing engaging portion (311) present on the inner surface of the side wall is moved, resulting in an inner casing under the inner enclosure holding portion (322) on the outer surface of the inner casing side wall (321). The top of the outer housing engaging portion (326 outer housing (309)) present on the outer surface of the body (320) is integrated with the side wall (302) of the outer housing. FIG. 7A shows the device (300). An exploded perspective view of the device to which the device is connected (outer housing (301), compressible cleaning matrix (305), and inner housing (320)) and NC (100) is shown (see FIGS. 7B, 7E). (100) has a threaded valve region (105) including a collar (101) below the threaded portion (102); the valve surface (110) is located at the top of the threaded valve region (105). . Valves are not shown in Figures 7A-7E.

FIG. 7B shows a perspective view of the assembled device (300) depicted in FIG. 7A, secured to the threaded region of the valve portion (105) of NC (100) depicted in FIG. 7A. Preferably, the plastic used for injection molding the outer housing (301) of the apparatus (300) shown in this embodiment is softer than the plastic used for molding the inner housing (302). .. Preferably, the plastic used to form the outer housing is with the inner housing to allow engagement between the inner housing and the engaging portion (326, 311) of the outer housing. Flexible enough to be squeezed by the user for the purpose of attaching and detaching the outer housing engagement (300) from the NC (100), but allowing the outer housing (301) to return to its original shape. Therefore, it is elastic enough to allow the engagement portion (326, 311) of the inner housing and the outer housing to be disengaged. This allows the user to, for example, engage the inner enclosure (326, 311) for a sufficient amount of time (eg, 1-15 seconds or longer) and / or a desired amount of rotation (eg, 360-3,600 degrees or higher). Rotate the outer enclosure (301) and matrix 305 relative to NC (100) when the cleaning operation is performed by rotating the device (300) without engaging only in the same or different directions. The valve surface (110) can be cleaned.

FIG. 7C is an exploded cross-sectional view of the components shown in FIG. 7A. In addition, the thin, flexible lip sealant (324) with a tapered shape integrated into the top surface of the inner enclosure (320) includes a matrix cavity (303) with a protruding matrix holding rib (307). It is designed to engage the sealing surface (308) at the bottom of the matrix well, which allows the user to translate the rotational force applied to the device (300) to the compressible cleaning matrix (305). The thread (326) on the inner surface of the inner housing (320) is designed to engage the complementary thread (102) of the thread area (105) of the NC (100).

As understood and as shown in the figure. 7C-7E, Compressible wash matrix (305) is inserted into matrix wells (303) during manufacturing. The matrix (305) can be impregnated with a cleaning reagent (eg, silver ion) and, in a preferred embodiment, a liquid disinfectant such as a 70% IPA solution. The bearing surface (323) of the outer housing holder (322), here the tapered flange formed as part of the inner housing (320) during manufacture, is on the inner surface of the main cavity (304) of the outer housing. It is designed to ride on an arranged complementary bearing surface (310). The inner housing holder (306) of the outer housing (301) is inside the main cavity (304) of the outer housing after the inner housing is assembled into a functional subassembly with the outer housing during manufacturing. Holds the housing (320). For example, the inner enclosure is ready to be infused with a compressible wash matrix (305) followed by a liquid disinfectant (eg, 70% IPA solution), sealed, packaged and sterilized. It may be pushed into the outer enclosure with sufficient force to bond to the functional subassembly. The inner housing engaging portion (311) existing on the inner surface of the side wall (302) of the outer housing is such that the outer housing (302) is on the outer surface adjacent to the inner housing (320). Allows engagement with 326).

FIG. 7D is a device of the invention assembled in a functional sealing and cleaning device (300) whose cross section can be attached to the threaded area of the valve portion (105) of the NC depicted in FIG. 7A (outer housing (outer housing (outer housing)). 301), compressible cleaning matrix (305), and inner enclosure (320)) components are shown. 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, which is surfaced by the user rotating the device (300) with respect to the NC. Can be washed. FIG. 7E is a cross section of the sealing and cleaning device (300) of the present invention screwed onto the NC, resulting in compression of the compressible cleaning matrix (305) against the valve surface (110) of the NC.

8 (8A-8E) show five different figures of another representative sealing and cleaning device of the present invention. In this embodiment, in the embodiment shown in FIG. 8, the matrix well (403) in the outer housing (401) is not the lip sealing body (324) in which the sealing body is located on the inner housing (320). ) Is similar to that depicted in FIG. 7 (FIGS. 7A-7E) m in that it is a tapered downwardly extending encapsulation (408) located on the bottom surface of the component forming the). ..

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

Specifically, FIG. 8 (FIGS. 8A-8E) shows the inner and outer enclosures (420) by the user squeezing the outer enclosure (401) (or applying pressure using two or more fingers). , 401) to slightly deform and move the inner housing engaging portion (411) present on the inner surface of the side wall of the outer housing to one or more (typically the outer housing (401)). Is engaged with the outer housing engaging portion (426) present on the outer surface of the inner housing (420) below the inner housing holding portion (422) on the outer surface of the side wall (421) of the inner housing. Five different figures of another representative sealing and cleaning device of the present invention (400) that fit together are shown. The top of the outer housing (409) is integrated with the side wall (402) of the outer housing. FIG. 8A shows an exploded perspective view of the device to which the device (400) is connected (outer housing (401), compressible cleaning matrix (405), and inner housing (420)) and NC (100) ( See Figures 8B and 8E). NC (100) has a threaded valve region (105) containing a collar (101) below its threaded portion (102). The valve surface (110) is located at the top of the threaded valve region (105). In Figures 8A-8E, the NC (100) valve is not shown.

FIG. 8B shows a perspective view of the assembled device (400) depicted in FIG. 8A, secured to the threaded region of the valve portion (105) of NC (100) depicted in FIG. 8A. Preferably, the plastic used for injection molding the outer housing (401) of the apparatus (400) shown in this embodiment is softer than the plastic used for molding the inner housing (402). .. Preferably, the plastic used to form the outer housing is with the inner housing to allow engagement between the inner housing and the engaging portions (426, 411) of the outer housing. Flexible enough to be squeezed by the user for the purpose of attaching and detaching the outer housing engagement (400) from the NC (100), but allowing the outer housing (401) to return to its original shape. Therefore, it is elastic enough to allow the engagement portions (426, 411) of the inner housing and the outer housing to be disengaged. Thereby, the user can, for example, hold the engaging portion (426) of the inner housing and the engaging portion (411) of the outer housing for a sufficient time (for example, 1 to 15 seconds or more) and / or desired. Outside the NC (100) when the cleaning operation is performed by rotating the device (400) without engaging in the same or different directions by the amount of rotation (eg, 360-3,600 degrees or more). The housing (401) and matrix 405 can be rotated to clean their valve surface (110).

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 placed on the bottom surface of the component forming the matrix well (403) within the outer housing (401). The sealant (408) has a sealing surface 409 designed to seal against the sealing surface (423) of the tapered flange of the holding portion (422) of the inner housing (420). As in the embodiment depicted in FIG. 7, the inner housing (420) is the main cavity (404) of the outer housing so that, for example, the inner housing (401) can be easily assembled with the outer housing (401). ), And by applying sufficient pressure to the point where the inner housing (420) passes over the inner housing holding portion (406) of the outer housing, the inner housing (420) becomes the outer housing. It is tapered so that it does not pull out of the body's main cavity (404) and provides a smooth interface that can be easily done. Low friction rotation between inner and outer enclosures (420, 401) If necessary,

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

FIG. 8D is a device of the invention assembled in a functional sealing and cleaning device (400) whose cross section can be attached to the threaded area of the valve portion (105) of the NC depicted in FIG. 8A (outer housing (outer housing (outer housing)). 401), compressible cleaning matrix (405), and inner enclosure (420)) components are shown. 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, which is surfaced by the user rotating the device (400) with respect to the NC. It becomes possible to wash. FIG. 8E is a cross section of the sealing and cleaning device (400) of the present invention screwed 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) show five different views of another representative sealing and cleaning device of the present invention. This embodiment is similar to that shown in FIGS. 8A-8E, with the difference being that in the embodiment shown in FIG. 9, the outer housing (501) is the embodiment shown in FIG. The side wall (502) forming the structural part of the device (500) has a step in it, giving the exterior the appearance of a layered "wedding cake". .. A series of outer ribs (535) are provided on the outer upper part of the outer housing to make the device (500) easier for the user to grip.

Specifically, FIG. 9 (FIGS. 9A-9E) shows five different views of another representative sealing and cleaning apparatus (500) of the present invention, wherein the user is in use of the outer enclosure (501). ) Is squeezed (or pressure is applied using two or more fingers) to engage the inner housing (520) and the outer housing (501) and slightly deform the outer housing (501). Move the inner engagement portion (511) of the side wall of the outer housing, and as a result, the inner housing (520) under the inner housing holding portion (522) on the outer surface of the side wall (521) of the inner housing. The top of the outer housing engaging portion (526 outer housing (509)) present on the outer surface of the outer housing is integrated with the side wall (502) of the outer housing. FIG. 9D shows the device (500) connected. An exploded perspective view of the outer enclosure (501), compressible cleaning matrix (505), and inner enclosure (520), as well as NC (100) (see FIGS. 9B, 9C). Has a threaded valve region (105) including a collar (101) below its threaded portion (102). The valve surface (110) is located at the top of the threaded valve region (105). For 9A-9E, NC (100) valves are not shown.

FIG. 9A shows a perspective view of the assembled device (500) depicted in FIG. 9D, secured in the threaded region of the valve portion (105) of NC (100) depicted in FIG. 9A. Preferably, the plastic used for injection molding the outer housing (501) of the apparatus (500) shown in this embodiment is softer than the plastic used for molding the inner housing (502). .. Preferably, the plastic used to form the outer housing is with the inner housing to allow engagement between the inner housing and the engaging portion (526, 511) of the outer housing. It is flexible enough for the user to attach and remove the outer housing engagement (500) from the NC (100), but allows the outer housing (501) to return to its original shape. Therefore, it is elastic enough to allow the engagement portion (526, 511) of the inner housing and the outer housing to be disengaged. Thereby, the user can, for example, hold the engaging portion (526) of the inner housing and the engaging portion (511) of the outer housing for a sufficient time (for example, 1 to 15 seconds or more) and / or desired. Outside the NC (100) when the cleaning operation is performed by rotating the device (500) without engaging in the same or different directions by the amount of rotation (eg, 360-3,600 degrees or more). The housing (501) and matrix 505 can be rotated to clean the valve surface (110).

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 placed on the bottom surface of the component forming the matrix well (503) within the outer housing (501). Be placed. The sealant (508) has a sealing surface 509 designed to seal against the sealing surface (523) of the tapered flange of the holding portion (522) of the inner housing (520). As in the embodiments depicted in FIGS. 7 and 8, for example, the inner casing (501) is up to the point where the inner casing (520) passes over the holding portion (506) of the outer casing. By applying enough pressure to the part to inflate the body (520) enough, the inner enclosure is tapered for easy assembly, in which respect the outer enclosure (401) contracts. However, the holdings (524, 510) of the inner and outer housings (522) prevent the 506 from pulling out the inner housing (520) from the outer housing (504) and the inner housing. Contact with the outer housing (520) to allow easy and low friction rotation 501) as needed and as needed.

As understood and as shown in the figure. 9B-9E, Compressible wash matrix (505) is inserted into matrix wells (504) during manufacturing. The matrix (505) can be impregnated with a cleaning reagent (eg, silver ion) and, in a preferred embodiment, a liquid disinfectant such as a 70% IPA solution. The bearing surface (524) of the outer housing holder (522), here also a tapered flange formed as part of the inner housing (520) during manufacturing, is the main cavity (504) of the outer housing. It is designed to ride on a complementary bearing surface (510) located on the inner surface. The inner housing holder (511) of the outer housing (501) allows the inner housing (520) to be the main cavity of the outer housing after the inner housing is assembled into a functional subassembly with the outer housing during manufacturing. Provided to be kept within (504). For example, the inner enclosure is ready to be infused with a compressible wash matrix (505) followed by a liquid disinfectant (eg, 70% IPA solution), sealed, packaged and sterilized. It may be pushed into the outer enclosure with sufficient force to bond to the functional subassembly. The inner housing engaging portion (511) existing on the inner surface of the side wall (502) of the outer housing is such that the outer housing (501) has an outer housing engaging portion on the adjacent outer surface of the inner housing (520). Allows engagement with (526).

FIG. 9D, cross section, shows the device of the invention (outer housing (501), compressible cleaning matrix) assembled into a functional sealing and cleaning device (500) that can be attached to the threaded area of the valve portion (105) of the NC. (505), and the components of the inner housing (520)) are shown. When the device (500) is attached to the NC (100), the NC contact surface of the matrix (505) contacts the valve surface (110) of the NC, which is surfaced by the user rotating the device (500) with respect to the NC. Can be washed. FIG. 8E is a cross section of the sealing and cleaning device (500) of the present invention screwed onto the NC so that the compressible cleaning matrix (505) is compressed against the valve surface (110) of the NC.

FIG. 10 shows that when the device (600) is screwed into the threaded valve region (105) of the needleless connector (100), the outer enclosure (601) is pushed upward by the compressible wash matrix (605). Three different cut views of another representative sealing and cleaning device (600) of the present invention are shown. To move upward, the outer housing (601) is placed in a neutral position where the engaging portions (611, 626) of the outer housing and the inner housing (601, 620) are disengaged, and the outer housing is placed. Allows (601) to rotate relative to the inner housing (620). figure. 10B and 10C show the device (600) fixed in the threaded region of the valve portion (105) of the NC, while FIG. 10A shows the device (600) disconnected from the NC (100). FIG. 10B shows the outer enclosure of the device in the neutral position (the engagements of the inner and outer enclosures are not engaged), from which the user can see the inner and inner enclosures. The outer enclosure (and compressible wash matrix) can be rotated relative to the fixed NC. As will be appreciated, the compressible wash matrix (605) pushes the outer enclosure (601) against the inner enclosure (620) in the absence of sufficient reaction downward force, which is required by the user. Depending on the inner housing (620) and NC, it can act as a spring or urging portion that allows the outer housing (and compressible cleaning matrix) to rotate. Without such rotation, the sealing and cleaning device (600) of the present invention is used to protect the threaded valve region (105) of the NC from environmental pollution, including microbial contamination, while connected to the NC. Works as a cap. Figure 10C shows the device (600) when the engaging parts (626,611) of the interior and exterior (620,601) are engaged, allowing screws to be inserted and removed on the NC (100). ..

In the embodiment shown in FIG. 10, the apparatus (600) also includes a sealant (630) disposed on the outer surface of the inner enclosure (620). The purpose of this encapsulation is preferably to keep the device according to the invention attached to the NC for at least 7 days, thus preventing rapid loss of liquid cleaning reagents from the device after the device is attached to the NC. It is to be.

As you can see, in the figure. 7-10, The lower surface (340, 440, 540, 640) of the side wall of the outer housing (301, 401, 501, 601) seals the internal space of the device (300, 400, 500, 600) from the external environment. A surface adapted to accept a lid or seal (not shown). This allows the cleaning reagents to be retained in the compressible cleaning matrix (320, 420, 520, 620) until certain ones are used to cap and / or clean the needleless connector. Not only does it make it possible to maintain the sterility of the device.

Unless the context explicitly requires otherwise, the terms "prepared", "prepared", etc. are to be construed in a comprehensive sense rather than an exclusive or exhaustive sense throughout the claims and attachments above. Words that use singular or plural in the sense that they should, i.e., include, but are not limited to, also include plural or singular, respectively. Moreover, the terms "here", "below", "above", "below", and similar meanings refer to the entire application and not to any particular part of the application. When the word "or" is used with reference to a list of two or more items, the word includes all of the following word interpretations: any of the items in the list, all of the items in the list. , And any combination of items in the list.

The above description has been described with reference to specific embodiments for purposes of explanation. However, the above exemplary discussion is not intended to be exhaustive or to limit the invention to the exact form disclosed. In view of the above description, many modifications and modifications are possible. Embodiments have been selected and described to best illustrate the principles of the invention and its practical uses, thereby accompanying various modifications suitable for other skilled skill in the art for the particular intended use. It has made it possible to make the best use of the present invention and various embodiments. Accordingly, the invention spans all functionally equivalent structures, methods, and uses, such as within the appended claims, and the invention is required by applicable legal rules. It is intended to be limited to a certain range.

Claims (12)

A sealing and cleaning device for needleless vessel access connectors with threaded valve portions.
(a) An inner housing configured so that the device can be screwed into the threaded valve portion of the needleless vessel access connector and the device can be unscrewed from the valve portion.
(b) Provided with a cavity in which the internal housing is located, configured to hold and engage the internal housing, but independently of the internal housing when not engaged with the internal housing. With an outer housing that can rotate,
(c) With a compressible wash matrix held in the outer enclosure and rotated with the outer enclosure, optionally impregnated with a disinfectant, optionally a 70% isopropyl alcohol solution.
A device equipped with. The device according to claim 1, further comprising a removable sealing body that seals the inside from the external environment. The apparatus according to claim 1, wherein the cleaning reagent optionally contains isopropyl alcohol, which is a 70% isopropyl alcohol solution. The device according to claim 1, wherein the outer housing includes an outer surface having a plurality of vertical ridges. A method of cleaning the needleless vessel access connector,
(A) By connecting the needleless vessel access connector to the sealing and cleaning device of claim 1, one or more surfaces of the connector engage with the compressible cleaning matrix and are compressible. The stage of compressing a part of the cleaning matrix and
(B) If necessary, the outer housing can be rotated with respect to the inner housing, and the outer housing can be rotated with respect to the inner housing and the connector to compress the outer housing. The step of cleaning the surface connected by the cleaning matrix and
How to have. 5. The method of claim 5, further comprising sealing the needleless vessel access connector by removing the needleless vessel access connector connected to the sealing and cleaning device after cleaning. A sealing and cleaning device for needleless vessel access connectors with threaded valve portions.
With inner and outer enclosures and a compressible cleaning matrix,
The inner enclosure comprises a substantially cylindrical sidewall forming a central bore opening at the upper and lower ends, an outer enclosure engaging region, and optionally an inner enclosure holding region.
One or more thread engagement tabs configured to hold the needleless vascular access connector and engage the threaded valve portion of the needleless vascular access connector to release the needleless connector if necessary. Alternatively, the thread is located close to the lower end opening and on the central bore.
The outer housing engagement area is configured to allow mechanical engagement and disengagement of the outer housing of the device.
The outer housing holding region holds the inner housing in the cavity of the outer housing and the inner housing of the outer housing when the outer housing engaging region is disengaged. Configured to allow rotation with respect to the body,
The outer enclosure is configured to releasably engage and hold a cavity formed by an outer wall and an upper wall, optionally concentric matrix wells, and the inner enclosure into the cavity. With the above engagement and holding structure,
When the engaging structure engages with the inner housing, the inner housing and the outer housing can rotate integrally, and when the engaging structure is disengaged from the inner housing. , The outer housing can rotate with respect to the inner housing,
The compressible wash matrix contains cleaning reagents that are internally located and secured to the matrix wells of the outer enclosure.
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 enclosure and the matrix are rotated relative to the inner enclosure. Configured to clean,
The cleaning reagent is optionally a 70% isopropyl alcohol solution.
Device. The device according to claim 7, further comprising a removable sealing body that seals the inside from the external environment. The apparatus according to claim 7, wherein the cleaning reagent optionally contains isopropyl alcohol, which is a 70% isopropyl alcohol solution. The device according to claim 7, wherein the outer housing includes an outer surface having a plurality of vertical ridges. A method of cleaning the needleless vessel access connector,
(A) By connecting the needleless vessel access connector to the sealing and cleaning device of claim 7, one or more surfaces of the connector engage with the compressible cleaning matrix and are compressible. The stage of compressing a part of the cleaning matrix and
(B) If necessary, the outer housing can be rotated with respect to the inner housing, and the outer housing can be rotated with respect to the inner housing and the connector to compress the outer housing. The step of cleaning the surface connected by the cleaning matrix and
How to have. 11. The method of claim 11, further comprising sealing the needleless vessel access connector by removing the needleless vessel access connector connected to the sealing and cleaning device after cleaning.

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