CN114401765A

CN114401765A - Capping and cleaning device for needleless vascular access connectors

Info

Publication number: CN114401765A
Application number: CN202080029883.2A
Authority: CN
Inventors: N·安德森; J·格兰特; D·M·钱伯斯; A·阿里艾利; D·G·松浦; P·J·辛普森
Original assignee: Cleansite Medical Inc
Current assignee: Cleansite Medical Inc
Priority date: 2019-02-19
Filing date: 2020-02-19
Publication date: 2022-04-26
Also published as: MA55036A; JP2022520491A; AU2020225386B2; CA3130950A1; AU2022204713A1; AU2020225386A1; EP3927415A4; JP2024037783A; EP3927415A1; WO2020172346A1; JP7402545B2

Abstract

Capping and cleaning devices for capping and cleaning needleless connectors, particularly luer access devices such as needleless vascular access connectors, and methods of using such devices are described. The apparatus of the present invention comprises: an inner housing and an outer housing connected to one another, the inner and outer housings being user-switchable between a locked or engaged position allowing them to rotate in unison and an unlocked or disengaged position allowing the outer housing to rotate about a central axis of the device independently of the inner housing; and a compressible cleaning matrix secured in the device, preferably in a well of the outer housing.

Description

Capping and cleaning device for needleless vascular access connectors

Technical Field

The present invention relates to cleaning devices for cleaning and capping medical devices, particularly luer access devices such as needleless valved connectors (NCs), and methods of making and using such articles.

Background

1. Introduction to the design reside in

The following description includes information that may be helpful in understanding the present invention. No admission is made that any such information is prior art or relevant to the presently claimed inventions, nor is any publication specifically or implicitly referenced as prior art.

2. Background of the invention

In the medical field, and particularly in the field of infusing fluids to or aspirating fluids from a patient, there remains a need to prevent the transmission of pathogens from potentially contaminating surfaces of medical devices, such as luer access devices, e.g., needleless valved connectors (NCs), into or onto the body of a patient. Pathogens include microorganisms (such as bacteria, fungi, and viruses), the transmission of which into a patient may result in potentially life-threatening infections. The term "nosocomial infection" describes, specific to a healthcare environment, an infection that originates or occurs in a hospital or hospital-like environment. In the united states, it is estimated that at least 5% of acute hospitalizations develop nosocomial infections. The estimated morbidity is over 200 million cases per year, resulting in significant morbidity, mortality, and expense. In fact, it is estimated that nosocomial infections double the mortality and morbidity risk of any hospitalized patient and may result in about 100,000 deaths in the united states for only a year. Common sites for the transmission of contaminating microorganisms into the bloodstream of patients are on medical devices such as luer access devices, vials, needleless (or needle-free) valves, and injection ports for blood vessels, tubing, and catheters. The incidence of such infections is increasing in patients, and improper cleaning of the site is often listed as a major source of such infections by Infection Control Practitioners (ICP).

As noted above, exposure of patients to pathogens and infectious agents (e.g., pathogenic bacteria, viruses, fungi, etc.) in medical environments (e.g., hospitals, outpatient surgery centers, home care environments, etc.) is a serious concern. One way of exposure to such agents is through an opening formed in the skin provided by a needle hole, cannula or other similar device for providing access to a patient's blood vessel. It is well known that patients with skin damaged in this way are at increased risk of developing serious bloodstream infections. In the united states alone, approximately 300,000 bloodstream infections per year are due to the installation and use of peripheral venous catheters (PIVCs), and over 80,000 bloodstream infections are associated with the use of Central Venous Catheters (CVCs). In summary, approximately 28,000 patients die annually in the united states from hospital acquired infections caused by PIVC and CVC use, and this figure (the patient referred to) is very often severely ill but still viable. In the united states alone, the costs associated with the care and treatment of patients infected by PIVC and CVC use are estimated to exceed $ 40 billion per year.

In today's hospital environment, occupational health and safety regulations designed to reduce the risk of healthcare workers experiencing needle sticks and similar injuries have led to the deployment of needleless medical valves (also referred to herein as "needleless connectors" or "NCs") whenever possible. Currently, hospitals in the united states use more than 10 million NCs per year. Needleless connectors are primarily used with PIVC and CVC devices and associated IV management and expansion equipment, which may contain as few as one, and as many as 3, 4, 5 or more NCs. FIG. 2A shows an example of a representative NC in use today.

The widespread use of needleless connectors in acute medicine has led to a significant increase in the incidence of Hospital Acquired Infections (HAI), particularly bloodstream infections (BSI). To reduce the risk of infection from microbially contaminated needleless connectors, current standard practice requires a nurse or other healthcare worker to clean (or "scrub") the surface of the NC as follows: those external surfaces thereof in the fluid path are rubbed vigorously with a sterile alcohol swab or wipe immediately prior to making a fluid connection with the NC (e.g., by attaching a syringe to a threaded valve portion of the NC to deliver medication via a PIVC already connected to the patient). In view of the severity of mortality and morbidity associated with HAI, particularly with respect to central venous cannulation related blood flow infection (CLABSI) and the massive blood flow infections caused by the use of PIVCs and CVCs, so-called "peripheral venous cannulation related blood flow infection (PLABSI) and central venous cannulation related blood flow infection (CLABSI), respectively, there is a long-recognized but significant unmet need for an article or device that can be used to reduce or eliminate the risk of causing HAI by merely entering a patient's blood vessel through a needle-free valve component of a PIVC or CVC inserted into the patient's blood vessel.

Traditionally, and as mentioned above, cleaning or disinfecting NC surfaces that may be contaminated includes protocols for alcohol wiping before making the necessary connections to the site. The alcohol swab is typically a small piece of cotton gauze soaked in isopropyl alcohol (IPA) which is individually packaged in an aluminum foil package to prevent evaporation of the IPA from the swab prior to use. A correct method of use is to open the package at or near the site to be wiped. The swab is removed by a gloved hand, nurse or other healthcare provider and used to scrub the top and side surfaces of the valve portion of the NC to be connected. After use, the swab and foil package will be discarded and the valve portion of the cleaned NC allowed to dry, typically for 20-30 seconds, before any connections are made. This "dry" period is important because as IPA dries, it destroys the cell walls of the microorganisms, thereby killing them.

Unfortunately, alcohol wipes for scrubbing) are often not or are not performed properly due to increased duties and responsibilities, reduced caregivers, and lack of training. An improperly wiped area may carry microorganisms that, if allowed to enter the patient, may cause a serious, potentially life-threatening infection. Furthermore, supervisory management is nearly impossible because unless a supervisor actually observes the scrub while executing, the supervisor cannot know whether the scrub program completed correctly or did not execute at all. In fact, compliance with this "scrub center (the hub)" protocol has been reported to be as low as 10%. Furthermore, if at least not enough microscopic examination of the microbial residue (e.g., biofilm) is performed, there may be no evidence of performing a "scrub center".

Accordingly, there remains a significant need for devices and techniques for cleaning a site on a medical device prior to use with or connection to a patient, and which eliminate technical-related and training issues and provide a clear indication that the "site is clean" prior to accessing the vascular system of the patient.

3. Definition of

Before describing the present invention in detail, several terms used in the context of the present invention will be defined. In addition to these terms, other terms are defined elsewhere in the specification as desired. Unless otherwise explicitly defined herein, technical terms used in the present specification will have their art-recognized meanings.

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

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

A "patentable" composition, process, machine, or article of manufacture according to the invention means that the subject matter in question satisfies all of the statutory requirements for patentability in performing an analysis. For example, with respect to novelty, non-obvious aspects, if subsequent investigation reveals that one or more claims encompass one or more embodiments that are not inventive, non-obvious aspects, etc. (which claims are to be limited by the definition of "patentable" embodiments), then such non-patentable embodiments are expressly excluded. Furthermore, the claims appended hereto should be construed to provide the broadest reasonable scope, and to preserve their validity. Furthermore, if one or more statutory requirements for patentability are amended, or if the criteria for evaluating whether a particular statutory requirement for patentability is met, from the time of filing or patent publication to the time when the validity of one or more appended claims is questioned, change occurs, the claims should be interpreted as follows: (1) maintaining its effectiveness; and (2) in this case to provide the broadest reasonable interpretation.

"plurality" means more than one.

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

Disclosure of Invention

The present invention aims to address these long-standing, but still unmet needs. The present invention addresses these needs by providing a patentable single use cleaning (disinfecting) and capping device or article that can be used to effectively and efficiently clean/disinfect and cap, and preferably sterilize, exposed surfaces of medical articles (such as luer access devices, particularly needleless connectors), particularly accessible surfaces of threaded valve portions of needleless connectors, particularly those surfaces (valve surfaces, threads, etc.) that may be contaminated with pathogens or other infectious agents and that constitute part of the fluid communication path between an external fluid source (e.g., a drug-filled syringe with a male luer connector, an IV bag, etc.) and the patient's bloodstream. In the context of the present invention, "cleaning" encompasses cleaning, disinfecting, decontaminating and/or sterilizing, whereas "capping" refers to the use of a device, i.e., a "cap", to cover one surface or a set of surfaces of an NC in order to limit or prevent exposure of such surfaces to the environment (e.g., air circulating in a hospital intensive care unit, microbial populations on the patient's skin, clothing, bedding, unclean fingers, etc.) longer than the time required to clean the desired surfaces of the needleless connector.

Accordingly, in one aspect, the present invention provides a capping and sterilizing device for a medical device, such as a luer access device, including a needleless valved vascular access connector (NC). Typically, such devices include: an inner housing configured to allow the device to be screwed onto and off of a threaded valve portion of an NC; an outer housing that holds the inner housing but which can be rotated by a user independently of the inner housing to provide a scrubbing or sanitizing action when desired; and a compressible cleaning matrix (matrix) preferably impregnated with a disinfectant (e.g., 70% IPA solution). The device also preferably includes an easily removable seal to maintain sterility and prevent loss of disinfectant after assembly of the device until it is used in the outer housing and cleaned NC in the field.

The device of the present invention comprises an inner housing. In some preferred embodiments, the inner housing is comprised of side walls defining a central internal (preferably cylindrical) bore spanning between oppositely disposed first and second (or upper and lower) openings, respectively. In many of these embodiments, the first (upper) opening is sized to allow a compressible cleaning substrate at least partially located in the substrate well of the outer housing or otherwise attached to the inner surface of the outer housing to protrude into the opening and through the opening into the central bore of the inner housing such that the compressible cleaning substrate can engage one or more outer surfaces of the needleless connector when the capping and cleaning device is secured to the connector. The second (lower) opening of the inner housing is sized to allow the threaded valve portion of a needleless connector to be capped and/or cleaned to be inserted into the capping and cleaning device of the present invention. The inner wall of the central bore of the inner shell includes one or more thread engaging tabs (or threads), preferably two (or more) oppositely disposed (or otherwise spaced apart) thread engaging tabs, preferably proximate the lower opening. The threaded engagement tabs (or threads) are configured to engage, for example, complementary threaded regions on the outer surface of the needleless connector, such that the capping and cleaning device can be fixedly threaded to (or otherwise removably connected to) a target threaded portion of the needleless connector via the threaded tabs or threads on the interior of the central bore of the inner housing in association with the complementary threads on the threaded portion of the needleless connector, to cap, and if desired, clean.

In some preferred embodiments, the outer surface of the inner housing comprises an outer housing retention area comprising one or more structures, such as a circumferential flange (or spaced apart flange elements) that allow the inner housing to be retained in the outer housing via association with one or more complementary structures (e.g., circumferential flanges (or spaced apart flange elements) or other suitable engagement elements) on the inner surface of the sidewall of the outer housing. Preferably, such a configuration of the complementary retaining elements also allows for a smooth, low-friction movement (i.e. rotation) of the inner and outer housing relative to each other during certain operations, e.g. during a sterilization procedure of the needleless connector. In some of these embodiments, the retention element of the inner housing may mechanically engage adjacent regions on the inner surface of the sidewall of the outer housing (e.g., when a user squeezes or otherwise applies sufficient force to the outer housing to deform it so as to allow the engagement regions on the inner surface of the outer housing to engage corresponding engagement regions on the outer surface of the inner housing), thereby allowing the inner and outer housings to rotate in unison (e.g., as may occur when a user attaches or removes a device to or from an NC). In some of these embodiments, the retaining element of the inner housing may also serve as an engagement element that abuts or is otherwise in close proximity to a complementary region, feature or structure on the inner surface of the sidewall of the outer housing. In other embodiments, the outer surface of the inner housing further comprises one or more outer housing engagement elements or regions designed to be associated with one or more inner housing engagement elements or regions disposed on the interior or inner surface of the outer housing. Examples of such elements include, for example, circumferential bands of spaced teeth or toothed elements protruding from the outer surface of the inner housing and positioned below an outer housing retention area (e.g., a circumferential flange), which teeth (or other suitable engagement structures) may be engaged by complementary structures arrayed on the inner surface of the outer housing when the housing is assembled as a functional subassembly.

In other preferred embodiments, the upper outer surface of the inner housing includes an outer housing engagement area that includes one or more structures that allow the inner housing to mechanically engage complementary structures (e.g., detents or other suitable engagement elements) on the inner surface of the top of the outer housing such that when the complementary engagement elements of the outer and inner housings are brought into close proximity, the engagement elements of the outer and inner housings engage, allowing the outer and inner housings to rotate in unison. Certain preferred embodiments of the outer housing engagement structure include spaced teeth (or other suitable engagement elements) arrayed on the top or upper surface of the preferably cylindrical sidewall of the inner housing. It will be appreciated that when such inner and outer housing engagement elements are disengaged or disengaged, a user may rotate or turn the outer housing relative to the inner housing, such as during a cleaning or sterilization operation of a needleless connector to which the device of the present invention is attached. Thus, when the capping and cleaning device is secured to the needleless connector, the user can rotate the outer housing (and the compressible cleaning substrate) relative to the inner housing and the connected needleless connector when such engagement elements are not functionally associated (or mated or otherwise engaged). On the other hand, when the inner surface of the top of the outer housing engages with complementary elements (all or at least in part) on the upper surface of the top of the inner housing, such as when a user applies downward pressure on the device to place it on or remove it from the needleless connector, the inner and outer housings rotate together, allowing, for example, for attaching or removing a capping and cleaning device to or from the NC.

In some preferred embodiments, the inner housing further comprises an NC sealing member configured to provide a fluid tight seal between the capping and cleaning device of the present invention and the needleless connector connected thereto. In some embodiments, the NC sealing member is an O-ring (or similar seal) preferably disposed in a channel formed in the inner surface of the wall of the inner housing proximate the second (lower) opening, typically below the thread engaging tabs (threads).

The device of the present invention further comprises an outer housing adapted or configured to retain the inner housing therein such that when the device is attached to the needleless connector, the outer housing can be rotated (preferably about its central axis) relative to the inner housing under certain conditions. Any suitable configuration of complementary mechanical or structural features or elements on facing or opposing surfaces may be used to provide retention of the inner housing within the main cavity of the outer housing and to allow engagement and disengagement of the outer housing with the inner housing so as to allow rotation of the outer housing relative to the inner housing when the device is attached to the needleless connector and a user desires to clean a corresponding surface of the NC using the capping and cleaning device of the present invention.

In some embodiments, when the device of the present invention is attached to a needleless connector, the inner housing and the outer housing are in a disengaged, neutral, or rotational configuration relative to each other such that a user can rotate the outer housing relative to the inner housing to perform a cleaning operation on a valve portion of an NC to which the device is attached. This disengaged, neutral or rotated configuration may be achieved by any suitable method, including by providing complementary engagement elements or structures on adjacent surfaces of the inner and outer housings that engage one another under certain conditions, for example, when a user pulls, pushes or squeezes the outer housing upwardly relative to the inner housing; otherwise, the engagement elements remain disengaged, which allows the outer housing to rotate relative to the inner housing when the device is secured to the NC. Features that allow for transitioning between the engaged and disengaged positions include a spring or biasing or resilient element or material. In other embodiments, when the device is attached to a needleless connector, the inner housing and the outer housing are in an engaged configuration relative to each other such that they rotate in unison unless a user applies sufficient force to the outer housing to disengage the engagement elements and thus allow the outer housing to rotate independently of the inner housing.

The outer housing includes a cylindrical cavity designed to receive and retain the inner housing using one or more features or elements that allow the outer housing to rotate relative to the inner housing if and when desired. The cavity is formed by a curved outer sidewall that, in some embodiments, is joined to the top portion of the housing about its periphery, and also preferably has a concentric central substrate well or substrate attachment area to which a compressible cleaning substrate is attached or otherwise associated, although some eccentricity between the substrate well and the central axis of rotation of the outer housing may be desired in some embodiments. In some embodiments, the outer housing is formed from a tapered and/or one or more stepped side walls.

In some preferred embodiments, the inner surface of the top of the outer housing includes one or more inner housing engagement elements or structures (e.g., teeth) designed to releasably engage complementary structures in the outer housing engagement area on the top of the inner housing. The engagement of the inner housing engagement structures of the outer housing with those in the outer housing engagement area of the inner housing allows a user to rotate the outer and inner housings in unison (e.g., when the inner housing of the capping and cleaning device is threaded onto the threaded portion of the needleless connector to be cleaned and/or capped). Once the device is releasably secured to the needleless connector via the inner housing, the inner housing engagement element or structure of the outer housing can be disengaged from (or from) the outer housing engagement element of the inner housing (e.g., by a biasing action or resiliency of the compressible cleaning substrate), thereby allowing a user to rotate the outer housing about its central axis relative to the inner housing. A representative example of such a joining structure is shown in published U.S. patent application publication No. 2018/0304067, although features such as: the inner housing has an opening at a top thereof to allow a compressible cleaning substrate attached to an inner surface of the top of the outer housing to extend into the aperture of the inner housing such that the compressible cleaning substrate is able to contact a surface of the needleless connector when the inner housing is connected to the needleless connector.

In some of these embodiments, the outer housing may include one or more vents to allow fluid and/or air inside the device to escape when the capping and cleaning device is secured to the needleless connector, while in other embodiments, no vents are provided. In embodiments having one or more vents, a membrane, filter, or other permeable or semi-permeable barrier may be employed to allow one-way or two-way flow of air, gas, or vapor through the vent, but prevent movement of microorganisms (e.g., bacteria, fungi, viruses, etc.) into the capping and cleaning device of the present invention.

In certain preferred embodiments, the outer surface of the outer housing of a capping and cleaning device according to the present invention comprises one or more grip enhancing structures (e.g., a plurality of vertical ridges) or coatings. Such grip enhancing structures or coatings facilitate a user grasping the housing of the capping and cleaning device between her/his fingers, which is useful not only during insertion and removal of the needleless connector from the capped cleaning device, but also during a cleaning process in which the user rotates the outer housing relative to the inner housing to scrub with the compressible cleaning matrix of the device to clean or sanitize the surfaces of the inserted needleless connector.

In some preferred embodiments, the device of the present invention includes one or more elements or features arrayed on facing surfaces of the inner and outer housings that allow a user to feel that the outer housing is rotating relative to the inner housing in order to provide a cleaning action on the valve surface of the NC to which the device is attached. Such sensory feedback may include one or more of audible, tactile, and/or visual stimuli generated from the device by rotation of the outer housing relative to the inner housing.

In the device of the present invention, the inner and outer housings are separately manufactured by any suitable process (e.g., 3D printing, injection molding, etc.) and then assembled into a two-part subassembly, wherein the inner housing is retained within the main cavity of the outer housing by one or more complementary retaining elements, features, or structures on each housing. The inner and outer housings also include complementary mechanical or structural engagement elements, features, or structures on one or more engagement surfaces that can be engaged and disengaged to allow the inner and outer housings to rotate together or to allow the outer housing to rotate independently of the inner housing. In this manner, the inner and outer housings can be associated such that they can be rotated in unison, allowing a user to thread (or screw) the device onto or remove (unscrew) from the threaded valve portion of the NC if and when desired, while also enabling the user to rotate the outer housing relative to the inner housing, allowing the compressible cleaning substrate to effectively scrub 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 housings further comprise complementary mechanical or structural housing seal elements, features or structures on one or more engagement surfaces that allow a seal to be formed between adjacent surfaces of the inner and outer housings, which seal is preferably a substantially fluid tight seal, but does not substantially impede or inhibit rotation of the outer housing relative to the inner housing during a cleaning procedure or procedure performed by a user. In some embodiments, the inner housing may also include a seal that interacts with the needleless connector to form an additional or alternative seal.

The capping and cleaning device of the present invention further comprises a compressible cleaning matrix disposed therein. In most embodiments, the compressible cleaning matrix is disposed in a matrix well or the like inside the outer housing, although any suitable retention configuration may be employed that allows the compressible cleaning matrix to rotate with the rotation of the outer housing so as to provide the ability to use the compressible cleaning matrix to scrub or otherwise clean, clean or disinfect the surface of the valve area of the needleless connector. It should be understood that the compressible cleaning substrate is positioned to contact one or more outer surfaces of the NC connected to the capping and cleaning device. A compressible cleaning matrix (e.g., an open cell or felted foam) is preferably retained in the matrix well by one or more matrix retaining elements that assist in retaining the compressible cleaning matrix in the matrix well in addition to transferring rotational forces from the outer housing to the compressible cleaning matrix (as occurs during procedures to disinfect and clean needleless connectors). It will be appreciated that during such rotation (of the outer housing and the compressible cleaning substrate), when the outer housing is rotated during a procedure to disinfect or clean the needleless connector, the compressible cleaning substrate also rotates relative to the inner housing. Upon insertion of the needleless connector into such capping and cleaning devices, the compressible cleaning matrix attached to or otherwise associated with the outer housing may be axially compressed (i.e., compressed along a central axis of the matrix well of the outer housing).

Because the surface of the needleless connector to be cleaned may be contaminated with microorganisms that form biofilms (i.e., a matrix of microorganisms and extracellular material attached to the surface that causes the microorganisms (typically bacteria and/or fungi) to adhere to the surface and perform certain biochemical processes), the compressible cleaning matrix also preferably has sufficient mechanical integrity when compressed and rotated to allow it to break any biofilm that may be present on the surface of the needleless connector, as may occur by rotating, twisting, or otherwise moving the subsequently compressed cleaning matrix relative to the needleless connector, such as by rotating the outer housing (to which the compressible cleaning matrix is attached) relative to the inner and inner housings of the capping and cleaning device. The friction generated between the compressed cleaning substrate and the surface of the needleless connector destroys the biofilm, thereby cleaning and preferably sterilizing the needleless connector. Leaving the capping and cleaning device secured to (i.e., capped) the needleless connector after such cleaning operation will limit and preferably preclude biofilm regrowth and/or microbial re-colonization of the cleaned surface (which remains in contact with the compressible cleaning substrate).

In a preferred embodiment, the compressible cleaning matrix includes one or more cleaning agent species dispersed therein, preferably at the time of manufacture of the device, although in some embodiments the cleaning agent may be dispersed into the matrix immediately prior to contact with the needleless connector. In the latter class of embodiments, the cleaning agent is preferably contained in a reservoir in the outer housing of the capping and cleaning device, the reservoir being configured to rupture immediately prior to performing the cleaning operation. In some embodiments, the capping and cleaning devices of the present invention will include a valve or opening to allow evaporation of the liquid in the cleaning agent.

In some preferred embodiments, the compressible cleaning substrate 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, while the other component is secured to the inner surface of the wall forming the inner housing (preferably between protruding threaded regions adapted to engage complementary threads on the needleless connector). If present, the member of compressible cleaning matrix secured to the inner surface of the inner housing wall is preferably configured to compress radially when associated with a needleless connector to be capped and cleaned.

In a preferred embodiment, the capping and cleaning device of the present invention comprises a removable cap or seal attached to the outer housing to seal the device, thereby isolating the interior space and structures of the inner and outer housings from the external environment. Such a cap or seal prevents the interior of the device (including the inner housing and the compressible cleaning matrix) from being exposed to the environment until the removable (preferably peelable) cap or seal is removed, typically by a healthcare worker before s/he uses the capping and cleaning device to clean, clean or sterilize the needleless connector to which a fluid connection is to be made. In preferred embodiments, such cleaning substantially destroys any microbial contamination (e.g., microbial biofilm or other microbial contamination that may be present on the surface in contact with the compressible cleaning substrate). If desired, the capping and cleaning device may be left in place (typically after cleaning the needleless connector attached thereto) to cap the needleless connector until it is further accessed, thereby minimizing exposure of the capped outer surface of the NC to potential pathogen contamination (and biofilm formation) from the surrounding environment. The cap or seal is typically installed during manufacture of the capping and cleaning device of the present invention. In those embodiments where the capped and cleaned device is sterilized (e.g., by irradiation, exposure to ethylene oxide, etc.) during manufacture, the cap or seal is preferably applied prior to packaging and sterilization.

In some preferred embodiments, the devices of the present invention are individually sealed, while in other embodiments, 2-20 or more devices are sealed to a single piece of cover or sealing stock, after which they can be separated into individual sealed products or maintained in a strip form, as a strip form having multiple devices all sealed to a single strip is a convenient form for use in a healthcare environment, where such a strip can be hung from an IV pole, for example, at a patient's bedside. After sealing and packaging, the devices of the present invention are sterilized using any suitable sterilization method (e.g., gamma or electron beam irradiation, treatment with ethylene oxide, etc.) that is compatible with the materials used to make the particular devices of the present invention.

Other aspects of the invention relate to methods of cleaning and/or capping a needleless connector using capping and cleaning devices according to the invention. Such methods generally include disengaging the engagement elements of the outer housing and the inner housing after the device has been connected to the needleless connector, thereby allowing a user to rotate or turn the outer housing relative to the inner housing and the needleless connector to which the device of the present invention is secured. Such disengagement does not impair contact between the compressible cleaning matrix of the device and the associated surface of the needleless connector. Rotation or spinning of the outer housing relative to the associated surfaces of the inner housing and the needleless connector allows these surfaces to be scrubbed, thereby cleaning them. Preferably, such a cleaning method provides for the disruption of any biofilm present on the surface of the needleless connector associated with the capping and cleaning device. And in those embodiments where the compressible cleaning substrate comprises one or more antimicrobial agents, microorganisms and pathogens present in such biofilms and/or on such surfaces are preferably destroyed or rendered non-viable.

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

Drawings

These and other aspects will now be described in detail with reference to the following drawings. Unless otherwise specified, it should be understood that the drawings are not to scale, as they are merely for ease of understanding the invention, and are not specifically dimensioned and so forth. In the drawings, like numerals in two or more drawings represent like elements.

Fig. 1 shows several views ((a) - (g)) of a representative capping and cleaning device of the present invention, its components (views (b) - (g)), and the device associated with a needleless connector (view (a)).

Fig. 2 shows an exploded view (a) of a representative capping and cleaning device of the present invention and a needleless connector, as well as several cross-sectional views (b) - (d)) of a sealed representative capping and cleaning device of the present invention (view (b)) and a capped needleless connector of such capping and cleaning device (views (c) and (d)).

Figure 3 shows six different views of a representative capping and cleaning device of the present invention. Views (a) - (c) show the device in a resting position, wherein the cap and the resilient inner body are engaged such that the cap, and thus the compressible cleaning substrate associated therewith, cannot rotate relative to the resilient inner body of the device. Views (d) - (f) show the same representative device having the cover and the resilient inner body in a movable relationship such that the cover (and the compressible cleaning substrate associated therewith) can rotate relative to the resilient inner body of the device.

Figure 4 shows a view of the lid portion of a representative capping and cleaning device of the present invention. View (a) shows a top view of the cover portion. View (b) shows a side view of the lid portion. View (c) shows a bottom view of the cover portion. View (d) shows a cross-sectional view of the lid portion. Representative measurement results for this particular embodiment are shown on views (b) and (d).

Fig. 5 shows seven different views ((a) - (g)) of the resilient inner body portion of a representative capping and cleaning device of the present invention. Representative measurements for this particular embodiment are displayed in several of the views.

Fig. 6 shows five different views ((a) - (e)) of a representative capping and cleaning device of the present invention, three of which show the compressible cleaning matrix portion thereof. Views (a) - (c) show top, side and bottom views of this particular compressible cleaning substrate. Views (d) and (e) show bottom and side views of the sealing portion of a representative capping and cleaning device of the present invention.

Figure 7 shows five different views of another representative capping and cleaning device of the present invention. Figure 7A shows an exploded perspective view of the device (outer housing, compressible cleaning substrate and inner housing) and the NC (see figures 7B, 7E) to which the device is to be attached. FIG. 7B shows a perspective view of the assembly device depicted in FIG. 7A secured to the threaded area of the valve portion of the NC depicted in FIG. 7A. Fig. 7C shows an exploded cross-sectional view of the components depicted in fig. 7A, while in fig. 7D, the cross-sectional view shows the assembly of the components of the device of the present invention (outer housing, compressible cleaning substrate and inner housing) into a functional capping and cleaning device ready for attachment to the threaded region of the valve portion of the NC depicted in fig. 7A. Figure 7E is a cross-section showing the capping and cleaning device of the present invention threaded onto the NC, which results in compression of the compressible substrate against the valve surface of the NC.

Figure 8 shows five different views of another representative capping and cleaning device of the present invention. Figure 8A shows an exploded perspective view of the device (outer housing, compressible cleaning substrate and inner housing) and the NC to which the device is to be attached (see figures 8B, 8E). FIG. 8B shows a perspective view of the assembly device depicted in FIG. 8A secured to the threaded area of the valve portion of the NC depicted in FIG. 8A. Fig. 8C shows an exploded cross-sectional view of the components depicted in fig. 8A, while in fig. 8D, the cross-sectional view shows the assembly of the components of the device of the present invention (outer housing, compressible cleaning substrate and inner housing) into a functional capping and cleaning device ready for attachment to the threaded region of the valve portion of the NC depicted in fig. 8A. Figure 8E is a cross-section showing the capping and cleaning device of the present invention threaded onto the NC, which results in compression of the compressible substrate against the valve surface of the NC.

Fig. 9 shows five different views of another representative capping and cleaning device of the present invention, where fig. 9A shows a perspective view of the device secured to the threaded area of the valve portion of the NC. Fig. 9B and 9C show exploded cross-sectional views of the device/NC assembly shown in fig. 9A, respectively, except that the view depicted in fig. 9C is slightly rotated about the central axis of the device/NC assembly as compared to the view depicted in fig. 9B. Figure 9D shows an exploded perspective view of the device depicted in figures 9A-9C (outer housing, compressible cleaning substrate, and inner housing). Fig. 9E shows a side cross-sectional view and a bottom view of the device depicted in fig. 9A-9D.

Figure 10 shows three different cross-sectional views of another representative capping and cleaning device of the present invention. Fig. 10B and 10C show the device secured to the threaded area of the valve portion of the NC, while fig. 10A shows the device disconnected from the NC. Figure 10B shows the outer housing of the device in a neutral position (the engagement elements of the inner and outer housings are not engaged) from which the user can rotate the outer housing (and compressible cleaning substrate) relative to the NC to which the inner and inner housings are secured. It will be appreciated that the compressible substrate may act as a spring which, in the absence of sufficient downward reaction force, urges the outer housing upwardly relative to the inner housing, thereby allowing the user to rotate the outer housing (and compressible cleaning substrate) relative to the inner housing and NC as and when desired. Without such rotation, the capping and cleaning device of the present invention, when connected to the NC, acts as a cap to protect the threaded valve area of the NC from environmental contamination (including microbial contamination). Fig. 10C depicts the device when the engagement elements of the inner and outer housings are engaged, allowing the device to be screwed onto or off the NC.

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

Detailed Description

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

The present invention relates to a patentable single use capping and cleaning device that can be used to effectively and efficiently clean, disinfect, and preferably sterilize exposed surfaces of needleless connectors, particularly those surfaces of luer access devices such as needleless medical valves that sometimes become part of the fluid communication path for introducing fluids (e.g., IV fluids, blood, plasma, medications, etc.) into a patient, as these surfaces are at risk of contamination by pathogens and infectious agents, such as bacteria, fungi, and viruses. "Disposable" (or "single-use") refers to articles or devices that are adapted for only one use or use, as distinguished from "dual" or "multi-use" devices. Thus, in the context of the present invention, a "single-use" capping and cleaning device is a useful device for cleaning, for example, a needleless medical valve. After the cleaning operation, if desired, the device may be left on the needleless connector until a subsequent fluid connection is made to prevent recontamination of the cleaned surfaces of the connector, as would occur if the capping and cleaning device of the present invention were removed immediately following the "scrubbing" of the connector without a subsequent fluid connection. After removal, the device of the invention is preferably discarded. However, prior to removal, the capping and cleaning device may be used again to clean the capping surface of the needleless connector.

In general, the capping and cleaning device of the present invention comprises: an inner housing configured to allow the device to be screwed onto and off of a threaded valve portion of an NC; an outer housing that holds the inner housing but which can be rotated by a user independently of the inner housing when desired to provide a scrubbing or sanitizing action; and a compressible cleaning matrix, preferably impregnated with a disinfectant (e.g., 70% IPA solution). The device also preferably includes an easily removable seal to maintain sterility and prevent loss of disinfectant after assembly of the device until it is used in the outer housing and cleaned NC in the field.

Generally, such devices include: an inner housing configured to allow the device to be screwed onto and off of a threaded valve portion of an NC; an outer housing that holds the inner housing but which can be rotated by a user independently of the inner housing when desired to provide a scrubbing or sanitizing action; and a compressible cleaning matrix, preferably impregnated with a disinfectant (e.g., 70% IPA solution). The device also preferably includes an easily removable seal to maintain sterility and prevent loss of disinfectant after assembly of the device until it is used in the outer housing and cleaned NC in the field.

The device of the present invention comprises an inner housing. In some preferred embodiments, the inner housing is comprised of side walls defining a central internal (preferably cylindrical) bore spanning between oppositely disposed first and second (or upper and lower) openings, respectively. In many of these embodiments, the first (upper) opening is sized to allow a compressible cleaning substrate at least partially located in the substrate well or otherwise attached to the inner surface of the outer housing to protrude into the opening and through the opening into the central bore of the inner housing such that the compressible cleaning substrate can engage one or more outer surfaces of the needleless connector when the capping and cleaning device is secured to the connector. The second (lower) opening of the inner housing is sized to allow the threaded valve portion of a needleless connector to be capped and/or cleaned to be inserted into the capping and cleaning device of the present invention. The inner wall of the central bore of the inner shell includes one or more thread engaging tabs (or threads), preferably two (or more) oppositely disposed (or otherwise spaced apart) thread engaging tabs, preferably proximate the lower opening. The threaded engagement tabs (or threads) are configured to engage, for example, complementary threaded regions on the outer surface of the needleless connector, such that the capping and cleaning device can be fixedly threaded to (or otherwise removably connected to) a target threaded portion of the needleless connector via the association of the threaded tabs or threads on the interior of the central bore of the inner housing with the complementary threads on the threaded portion of the needleless connector, to cap, and if desired, clean.

In some preferred embodiments, the outer surface of the inner housing comprises an outer housing retention area comprising one or more structures, such as a circumferential flange (or spaced apart flange elements) that allow the inner housing to be retained in the outer housing via association with one or more complementary structures (e.g., circumferential flanges (or spaced apart flange elements) or other suitable engagement elements) on the inner surface of the sidewall of the outer housing. Preferably, such a configuration of the complementary retaining elements also allows for a smooth, low-friction movement (i.e. rotation) of the inner and outer housing relative to each other during certain operations, e.g. during a sterilization procedure of the needleless connector. In some of these embodiments, the retention element of the inner housing may mechanically engage adjacent regions on the inner surface of the sidewall of the outer housing (e.g., when a user squeezes or otherwise applies sufficient force to the outer housing to deform it so as to allow the engagement regions on the inner surface of the outer housing to engage corresponding engagement regions on the outer surface of the inner housing), thereby allowing the inner and outer housings to rotate in unison (e.g., as may occur when a user attaches or removes a device to or from an NC). In some of these embodiments, the retaining element of the inner housing may also serve as an engagement element that abuts or is otherwise in close proximity to a complementary region, feature or structure on the inner surface of the sidewall of the outer housing. In other embodiments, the outer surface of the inner housing further comprises one or more outer housing engagement elements or regions designed to be associated with one or more inner housing engagement elements or regions disposed on the interior or inner surface of the outer housing. Examples of such elements include, for example, circumferential bands of spaced teeth or toothed elements protruding from the outer surface of the inner housing and positioned below an outer housing retention area (e.g., a circumferential flange), which teeth (or other suitable engagement structures) may engage by complementary structures arrayed on the inner surface of the outer housing when the housing is assembled as a functional subassembly.

In some of these embodiments, the apparatus of the present invention comprises: a resilient inner body disposed within the cap, the resilient inner body being rotatable or swiveling relative to the cap when the capping and cleaning device is secured to the needleless connector; and a compressible matrix member containing one or more antimicrobial agents and having a structure that allows the capped surface of the needleless connector to be cleaned. More specifically, the resilient inner body has a wall defining a central inner (preferably cylindrical) bore extending between oppositely disposed first and second (or upper and lower, respectively) openings. The inner wall of the central bore closer to the second (lower) opening comprises one or more thread engaging tabs (or threads), which are preferably two thread engaging tabs disposed opposite each other. The threaded engagement tabs (or threads) are configured to engage complementary threaded regions on the outer surface of, for example, a needleless medical valve. This allows the capping and cleaning device to be fixedly threaded onto the target threaded portion of the needleless connector for cleaning and, if desired, capping that portion of the needleless connector. The outer surface of the resilient inner body includes one or more structures that allow the resilient inner body to mechanically engage and disengage complementary structures provided on the inner surface of the cap.

In many embodiments, the outer surface of the resilient inner body includes a cap engagement region that includes one or more features that allow the resilient inner body to mechanically engage and disengage complementary engagement features on the inner surface of the cap, such as spaced apart projections (e.g., teeth). A preferred embodiment of the cap engagement structure includes alternating teeth and grooves (or channels) arrayed around the outer circumference of the resilient inner body that are complementary to one or more spaced apart engagement structures (e.g., teeth) provided on the inner surface of the outer wall of the cap. In other embodiments, the cover engagement region of the resilient inner body is provided on an inner surface thereof for engagement with one or more complementary engagement structures (e.g., teeth) arrayed on an outer or exterior surface of the substrate well wall. It should be understood that in configurations that include teeth and channels, the "teeth" may be raised projections and the "channels" may be spaces or gaps between raised projections.

The resilient inner body also includes a compressible region. In many preferred embodiments, it is located above the thread engaging tab (or thread) and the cap engaging region. The compressible region can be any structure that allows the resilient inner body to be compressed to bring the first and second openings closer together to allow disengagement of the engaging structures of the cap and the resilient inner body. In preferred embodiments, the compressible region is a torsion spring, which in certain particularly preferred embodiments is a molded torsion spring formed from plastic or other sufficiently flexible or resilient material (preferably formed as part of the resilient inner body during injection molding).

In some embodiments, the resilient inner body is made of two parts, which are then assembled to form the complete inner body. For example, during manufacture of the capping and cleaning device of the present invention, the resilient inner body may be formed as two or more separate parts that are assembled together (one on top of the other). For example, in embodiments where the resilient inner body is made of two parts, the upper part preferably comprises a compressible region (e.g., a torsion spring formed during injection molding of the upper part), while the lower part comprises a cap engagement region and a thread engagement tab (or thread). In contrast, a representative three-part embodiment of the resilient inner body comprises: an upper section comprising a first (upper) opening and a compressible region; a middle section comprising a lid engagement region; and a lower section comprising a threaded engagement tab (or thread) and a second (lower) opening. In an alternative three-part embodiment, the upper section includes a first (upper) opening and a cover engagement region, the middle section includes a compressible region, and the lower section includes a threaded engagement tab (or thread) and a second (lower) opening. It should be understood that the present invention encompasses all possible combinations of portions having a cap engagement region, a compressible region, and a region of threaded engagement with the threaded portion of the needleless connector, provided that the final combination can be compressed to provide the cap engagement and disengagement function, such that when the cap and corresponding structure on the inner body are engaged, the cap and inner body can rotate together about their central axes, and when the cap and corresponding structure on the inner body are disengaged by compression of the compressible region, the user can rotate the cap about its central axis relative to or independent of the resilient inner body (i.e., the cap rotates without the resilient inner body rotating).

In embodiments of the invention where the resilient inner body is made of two or more parts, the parts are preferably mechanically connected after assembly so that they also move in unison, for example when capping and cleaning devices (of which the parts are a part) are screwed onto a threaded portion of a needleless connector, such as a needleless connector. Any suitable mechanical lock and corresponding set of mechanical structures may be used to link the parts together.

In some preferred embodiments, the inner housing or the resilient inner body further comprises a sealing member (i.e., a seal) configured to provide a fluid tight seal between the capping and cleaning device of the present invention and the NC connected thereto. The seal is preferably disposed in a channel formed in the inner surface of the wall of the resilient inner body proximate the second (lower) opening, generally below the thread engaging tabs (or threads).

Each device of the present invention further includes an outer housing or cover operatively associated with the inner housing, such as the resilient inner body. The cover generally comprises: an outer cavity formed by a curved outer wall joined to the top portion, preferably around the periphery of the top portion; and a preferably concentric central matrix well extending from the inner surface of the top into the outer chamber. The walls forming the matrix wells are spaced from the outer walls of the cover to form resilient member receptacles accessible through openings formed by gaps between the walls of the cover and the matrix well walls. In many preferred embodiments, the inner surface of the outer wall of the cap includes one or more engagement or locking structures (e.g., teeth) that are designed to releasably engage (i.e., corresponding structures can engage and disengage as desired) complementary structures in the cap engagement region of the resilient inner body. In other embodiments, an engagement or locking structure of the cover is provided on the outer surface of the substrate well wall, the locking structure being designed to releasably engage a complementary structure in the cover engagement region on the inner wall of the resilient inner body. For example, when the capping and cleaning cap is screwed onto the threaded portion of the needleless connector to be cleaned and/or capped, the engagement of the engagement or locking structures of the cap with those in the cap engagement region of the resilient inner body allows the user to rotate the cap and resilient inner body in unison. Once the device is releasably secured to the needleless connector, the locking structures of the cap can be disengaged from those in the cap engagement region of the resilient inner body, thereby allowing the user to rotate the cap relative to the resilient inner body about its central axis. In some embodiments, the cap may include one or more vents to allow fluid and/or air inside the device to escape as the capping and cleaning device is secured to the needleless connector, while in other embodiments, no vents are provided.

The capping and cleaning device of the present invention further comprises a compressible cleaning matrix in the matrix well of the outer housing. The compressible cleaning substrate may be, for example, an open cell foam. The cleaning substrate is preferably secured to the inner surface of the outer housing to limit or impede its rotation independent of the outer housing during rotation of the outer housing. The compressible cleaning substrate is configured to contact and clean one or more surfaces of the needleless connector that contact the substrate when the needleless connector is associated with the capping and cleaning device of the present invention. Upon insertion of the needleless connector into the capping and cleaning device, the compressible cleaning matrix attached to or otherwise associated with the outer housing may be axially compressed (i.e., compressed along a central axis of the matrix well of the outer housing).

Because the needleless connector surface to be cleaned may be contaminated with microorganisms that form biofilms (i.e., a matrix of microorganisms and extracellular material attached to the surface that causes the microorganisms (typically bacteria and/or fungi) to adhere to the surface and perform certain biochemical processes), the compressible cleaning matrix preferably has sufficient mechanical integrity when compressed to allow it to be used to disrupt any biofilm that may be present on the surface of the needleless connector in contact with the cleaning matrix. Disruption of the biofilm may occur by rotating, twisting, or otherwise moving the subsequently compressed cleaning substrate relative to the needleless connector (e.g., a needleless medical valve), for example, by rotating an outer housing (to which the compressible cleaning substrate is attached or otherwise associated or held) relative to an inner housing (e.g., an elastomeric inner body) of the capping and cleaning device and the needleless connector to which the inner housing is releasably attached. The friction generated between the compressed cleaning substrate and the surface of the needleless connector destroys the biofilm, thereby cleaning and preferably sterilizing the needleless connector. Having the capping and cleaning device secured to (i.e., capped) the needleless connector after such cleaning will limit and preferably preclude biofilm regrowth and/or microbial re-colonization of the cleaned surface of the needleless connector, which remains in contact with the compressible cleaning substrate.

In a preferred embodiment, the compressible cleaning matrix includes one or more cleaning agent species dispersed therein, preferably at the time of manufacture of the device, although in some embodiments the cleaning agent may be dispersed into the matrix immediately prior to contact with the needleless connector. In the latter class of embodiments, the cleaning agent is preferably contained in a reservoir in the body of the capping and cleaning device, the reservoir being configured to rupture when associated with the needleless connector for cleaning. Such a reservoir may be disposed between the substrate and the needleless connector, or more preferably, between the rotatable cap and the compressible cleaning substrate. Preferred cleaning agents include antimicrobial agents (such as isopropyl alcohol, chlorhexidine, and silver ions). In some embodiments, the capping and cleaning devices of the present invention will include a valve or opening to allow evaporation of the liquid in the cleaning agent.

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

As described above, the central substrate well is adapted to receive a compressible cleaning substrate. The surface of the central substrate well that is in contact with the substrate preferably includes one or more retaining structures to retain the compressible cleaning substrate, linking its rotation or movement with the rotation or movement of the cover, particularly when the engaging structures of the cover and the resilient inner body are disengaged so as to allow the cover to rotate during the needleless connector cleaning procedure. Such retaining structures include ridges and other protrusions that protrude from the surface of the central substrate well that is in contact with the compressible cleaning substrate. An adhesive may also be used to bond the portion of the compressible cleaning matrix to a desired location in the matrix well.

In various embodiments, the outer surface of the outer housing of a capping and cleaning device according to the present invention comprises one or more grip enhancing structures or coatings (e.g., a plurality of vertical ridges). Such grip enhancing structures or coatings facilitate a user gripping the body of the capping and cleaning device between her/his fingers, which is useful not only during insertion and removal of the needleless connector from the capped cleaning device, but also during a cleaning process in which the user rotates the outer housing relative to the inner housing to scrub with the compressible cleaning substrate to clean/sanitize the surfaces of the inserted needleless connector.

The inner and outer housings may be made of any suitable material or combination of different materials. Particularly preferred is plastic. The material used to manufacture the outer shell may be the same as or different from the material used to produce the inner shell.

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

The compressible cleaning matrix may be positioned in the matrix well before or after the inner and outer housings are operably associated. In a preferred embodiment, the compressible cleaning substrate (or individual portions of the substrate if the substrate comprises two or more portions) is fixedly bonded to one or more interior surfaces of the substrate well of the outer housing using a suitable adhesive. In some embodiments, the surface of the matrix well in contact with the compressible matrix includes structure to help hold the matrix securely in the well, ensuring that it moves with the lid as the outer housing is rotated during the cleaning procedure.

In a preferred embodiment, the capping and cleaning device comprises a removable cap or seal attached to the outer housing to seal the device, thereby isolating the interior space and structure of the device from the external environment. Such a cap or seal prevents the interior of the device (including the inner housing and the compressible cleaning substrate) from being exposed to the environment until the seal is removed, typically by a healthcare worker before she/he is to cap the needleless connector (e.g., needleless medical valve) to which it is connected using a capping and cleaning device, and then clean/clean the needleless connector if desired. In a preferred embodiment, such cleaning substantially disrupts any biofilm that may be present on the surface in contact with the compressible cleaning substrate. If desired, the capping and cleaning device may be left in place (typically after cleaning the needleless connector attached thereto) to cap the needleless connector until it is further accessed, thereby minimizing exposure of the capped outer surface of the connector to potential pathogen contamination (and biofilm formation) from the surrounding environment. The seal is typically installed during manufacture of the capping and cleaning device of the present invention. In those embodiments where the capping and cleaning device is sterilized (e.g., by irradiation, exposure to ethylene oxide, etc.) during manufacture, it is preferred that the seal be applied prior to sterilization.

Other aspects of the invention relate to methods of cleaning and/or capping a needleless connector using capping and cleaning devices according to the invention. Such methods generally involve transitioning the inner and outer housings from an engaged configuration to a disengaged configuration after the device has been connected to the needleless connector to allow the outer housing to be turned or rotated relative to the inner housing. This compression facilitates contact between the compressible cleaning matrix of the device and the associated surface of the needleless connector. Rotation or spinning of the outer housing relative to the inner housing and associated surfaces of the needleless connector allows these surfaces to be scrubbed, thereby cleaning them. Preferably, such a cleaning method provides for the disruption of any biofilm present on the surface of the needleless connector associated with the capping and cleaning device. And in those embodiments where the compressible cleaning substrate comprises one or more antimicrobial agents, microorganisms and pathogens present in such biofilms and/or on such surfaces are destroyed or rendered non-viable.

In this context, the compressible cleaning matrix of the capping and cleaning device of the present invention comprises one or more cleaning agent species dispersed in a base material. The cleaning substrate can be any of the following: which can be conformed, shaped or compressed in a manner that is effective to enable friction-based cleaning of the portion or portion of the needleless connector to be cleaned, including the top surface, side surfaces of the portion, and any threads or grooves, if present, and to provide a cleaning agent at least at the surface level. Examples of compressible cleaning substrates include cotton, open or closed cell foam (such as polyethylene foam), or other substances that can contain or carry a cleaning agent.

In some embodiments, the cleaning agent species is dispersed in or otherwise combined with the compressible cleaning matrix during the process for manufacturing the capping and cleaning device, while in other embodiments, the device is configured such that the cleaning agent is released to disperse into the compressible cleaning matrix at a time after manufacture, but at or before the time when the matrix is in contact with the needleless connector to be cleaned. The cleaning agent may be any chemical, substance or material that cleans up bacteria or even sites of viral microorganisms, biofilms, etc., or any carrier that contains such a chemical, substance or material. Examples of cleaning agents include isopropyl alcohol, chlorhexidine digluconate, povidone iodine, hydrogen peroxide, soap, and hydrochloric acid, silver ions and salts (e.g., silver acetate, silver lactate, silver nitrate, etc.), and the like.

According to the present invention, the cleaning agent includes an active ingredient capable of cleaning the surface of the needleless connector. Any active ingredient that is effective for quick cleaning of medical connectors or medical line connectors (e.g., needleless connectors) can be suitable for practicing the present invention and is generally classified as an antibacterial and/or antifungal agent, a preservative or antimicrobial agent, a broad spectrum disinfectant and/or parasiticide, and combinations of these agents. Particularly preferred are biocompatible cleaning agents, as the device of the invention is intended for human and/or veterinary use, including alcohols, antibiotics, oxidants and metal salts. Representative examples of such active ingredients include bleach, chlorhexidine, ethanol, isopropanol, hydrogen peroxide, sodium hydroxide, and iodophors dissolved or otherwise dispersed in a suitable solution, suspension, or emulsion. Other active ingredients with suitable cleaning effect may also be used. These ingredients include: alcohols (e.g., ethanol, benzyl alcohol, isopropyl alcohol, phenoxyethanol, phenylethyl alcohol, etc.); antibiotics (e.g., aminoglycosides such as amikacin, apramycin, gentamicin, kanamycin, neomycin, netilmicin, paromomycin, streptomycin, and tobramycin; bacitracin, chloramphenicol, erythromycin, minocycline/rifampin; tetracyclines; quinolones such as oxalic acid, norfloxacin, nalidixic acid, pefloxacin, enoxacin, and ciprofloxacin; penicillins such as oxacillin and piperacillin; nonanol 9; fusidic acid; cephalosporins; etc.), quaternary ammonium chlorides; a quaternary ammonium carbonate salt; benzalkonium chloride; chlorinated phenols; fatty acid monoesters of glycerol and propylene glycol; iodine; iodine-containing compounds: such as 3-iodo-2-propynyl butyl carbamate (IPBC); iodophor: such as povidone iodine (Betadine 100%, which contains, as an active ingredient, a natural iodine); hydantoin: such as dimethylhydantoin and halogenated hydantoin; isothiazolinones; p-hydroxybenzoic esters: such as methyl, ethyl and propyl parabens; chloroxylenol; chlorhexidine and salts thereof; chlorhexidine/silver sulfadiazine; chlorhexidine acetate; chlorhexidine gluconate (e.g., Hibidens); chlorhexidine hydrochloride; chlorhexidine sulfate; benzoic acid and salts thereof; benzalkonium chloride; benzethonium chloride; methylbenzyl ammonium chloride; chlorobutanol; sorbic acid and its salts; imidazole antifungals (e.g., miconazole); butoconazole nitrate; (ii) a mefenamate acetate; furacilin; nitrobenzene; triclocarban; phenylmercuric nitrate or acetate (0.002%); chlorocresol; chlorobutanol; clindamycin; CAE (Anjinomoto co., inc., DL-pyrrolidone carboxylic acid salt with ethyl L-cocoyl arginine); ethyl pyridinium chloride (CPC) at concentrations of 0.2%, 0.02%, and 0.002%; 9.8% isopropyl alcohol; 1% ZnEDTA; mupirocin; and polymyxins (polymyxin b sulfate-bacitracin). Additionally, other useful compounds and compositions include miconazole, econazole, ketoconazole, oxyconazole, halopropanes, clotrimazole, butenafine hydrochloride, naftifine, rifampin, terbinafine, ciclopirox, tolnaftate, lindane, lamilast, fluconazole, amphotericin B, ciclopirox, asperginine, triclosan (2,4,4 '-trichloro-2' -hydroxydiphenyl ether), miazino (5-chloro-2 phenol (2,4 dichlorophenoxy), useful metals include silver and its salts, including silver acetate, silver benzoate, silver carbonate, silver citrate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein, and silver sulfadiazine the cleaning agents are generally compositions that include the desired active ingredient in admixture with other ingredients, such as carriers and liquid solvents.

The particular active ingredient selected as a cleaning agent for a given application will be compatible with the compressible cleaning matrix and materials used to form the outer housing, inner housing, and other components of the particular device. In some embodiments, the cleaning agent is dispersed in the compressible cleaning matrix after the matrix is formed. For example, the cleaning agent may be dispensed during manufacture of the device, preferably before it is sealed, by saturating or over saturating the compressible cleaning matrix. In other embodiments, the cleaning agent may be dispersed during the process for making the compressible cleaning matrix. It will be appreciated that the materials used to prepare the cleaning agent should be compatible with the one or more components comprising the compressible cleaning matrix such that the substrate does not significantly degrade or otherwise suffer loss of structural integrity before being used to clean a needleless connector (e.g., a needleless medical valve). Also, the cleaning agent should be biocompatible so that it does not harm the patient when it contacts the patient or when a quantity of cleaning agent enters the fluid carrying portion of the needle-free medical valve, and should also be biocompatible with the material used to form the needle-free medical valve (or other needle-free connector).

In preferred embodiments, the material used to form the compressible cleaning matrix is any suitable absorbent, compliant, flexible, resilient, fibrous or porous material, or combination of such materials, that can be wetted and/or impregnated with cleaning agents and that can easily and quickly conform to complex surface contours (e.g., luer threads, concave and convex surfaces, flanges, etc.) that may engage upon contact with, for example, a needleless medical valve to be cleaned. Such materials include synthetic or naturally occurring materials, and they may have homogeneous or heterogeneous compositions. Preferred synthetic materials include fibers, foams (e.g., felted foams), and gel compositions, particularly those having oriented natural or synthetic fibers or combinations thereof. Preferred naturally occurring materials for use as the substrate include fibrous naturally occurring materials, including materials of plant origin (such as cotton and paper products), and animal-based fibrous products (such as wool). Other preferred natural materials are sponges.

It will be appreciated that in order to achieve the desired cleaning effect, the compressible cleaning matrix or component parts thereof that are designed to contact a needleless connector, such as a needleless medical valve, are preferably made of the following materials (or combination of materials): they allow the cleaning element to thoroughly clean the surfaces of needleless connectors, such as needleless valves or luer access devices, particularly those surfaces that are exposed to air and therefore at risk of contamination by infectious or pathogenic agents and biofilms containing them, as well as those surfaces intended to form part of a fluid flow path for introducing fluids (e.g., IV solutions, drugs, blood and blood products, etc.) into a patient.

Preferably, the material used to produce the compressible cleaning substrate should be sufficiently compliant to allow the compressible cleaning substrate to deform under the pressures experienced during normal use to conform to the external structures present on the surface of the needleless connector to be cleaned. This ensures intimate cleaning contact between the compressible cleaning matrix and at least those exposed surfaces of, for example, a needleless connector that are designed to be in contact with fluid entering the valve (such as IV fluid). Furthermore, the compressible cleaning matrix preferably allows for the liquid cleaning agent to be held in a capillary space of void volume, such as a foam, sponge, or the like. The compressible cleaning matrix may also be designed such that it includes a cleaning agent (such as silver ions and/or other suitable materials).

Preferred natural materials from which the compressible cleansing base can be formed include those derived from cotton and naturally occurring sponges. As understood by those skilled in the art, processed cotton fibers consist almost entirely of natural polymer cellulose. In such fibers, 20-30 layers of cellulose are coiled into a series of spring configurations, which make the fibers absorbent and impart a high degree of durability and strength to them. For example, a woven cotton sheet commonly used to make sterile cleaning pads that are then saturated with a 70% isopropyl alcohol (IPA) solution may be used as the substrate for the cleaning elements according to the present invention. Any suitable configuration may be used. For example, a woven cotton sheet may be cut into a number of similarly sized pieces, each of which may be used as a substrate. In many embodiments, after attachment to the inner surface of the layer of the container (e.g., by using an adhesive, double-sided tape, etc.), the substrate is ready for addition of a suitable cleaning agent. Alternatively, cotton fibers may be spun onto the inner surface of the lid. Other fibers having similar properties, whether they are naturally occurring, synthetic, or a combination of natural and synthetic materials, may also be readily adapted for use as a compressible cleaning matrix.

Another class of materials used in the manufacture of compressible cleaning matrices are oriented fiber materials. These materials include, but are not limited to, materials composed of cellulose fibers, glass fibers, and polyester fibers, as well as materials composed of combinations of two or more of these and/or other materials. Such bonded synthetic fibers precisely absorb, hold, transfer and/or release a desired amount of liquid or vapor by capillary action. A variety of synthetic polymers may be used to form the fibers and, if desired, they may be treated for functional purposes, e.g., to contain a cleaning agent dispersed therein, to provide a vapor barrier or other coating on a portion of the surface of the product, etc. The geometry of these materials can also be tailored for specific applications, allowing for easy integration into substrate configurations having desired device thicknesses, widths, lengths, diameters, and the like.

Other representative classes of materials suitable for use as a compressible cleaning substrate include gel-forming polymers and foams (such as agarose, agar, polyacrylamide) and other synthetic porous materials, which can be formed into layers, sheets, columns or other shapes compatible with the practice of the present invention. Representative gel materials include hydrogels (i.e., crosslinked polymers that absorb and retain moisture), particularly those made from agarose, (2-hydroxyethyl) methacrylate and its derivatives, and the synthetic carbohydrate acrylamide.

Still other classes of materials include porous polymer sponges. Such a sponge may be formed from any suitable material including polyethylene, polypropylene, polytetrafluoroethylene, polyvinylidene fluoride, polynitrile, and polystyrene. Many such porous polymer sponges are commercially available in a variety of shapes, pore densities and sizes, etc. Additionally, the polymer sponge may be manufactured by polymerizing suitable monomers according to conventional foam forming techniques. Typically, the sponge has an open cell structure to allow for the movement of a solvent (such as a liquid cleaning agent). The sponge surface should include openings to provide access to liquid cleaning agents (e.g., alcohol, iodine-containing solutions, etc.), and the particular material selected is preferably inert, i.e., non-reactive with the components of the cleaning agent, the body of the capping and cleaning device, or the material used to produce the needleless connector, such as a needleless medical valve, as with other materials used to form the matrix.

Surgical foam (surgical foam) is another preferred class of materials that can be used to make compressible cleansing matrices. The material may be natural or synthetic, as desired. Suitable foams include rubber latex, polyurethane, polyethylene, and vinyl foams. Preferably, such foam is made of any suitable biocompatible polymer, such as polyvinyl alcohol (PVA) or polyurethane. A preferred foam material is Microbisan^TMIt is a hydrophilic polyurethane foam impregnated with silver ions (Lendell Manufacturing, st. charles, MI). Preferably, such foams are highly absorbent and are therefore suitable for use with liquid cleaning agents. In other embodiments, the material used to form the foam is well suited to disperse dry cleaning agents (such as silver ions). Also, the foam material, if used as a substrate, is preferably inert. Moreover, given the wide variety of shapes, sizes, and configurations of medical valves, they are preferably flexible enough to conform to the various different shapes and surface configurations encountered in the field (e.g., dual seal fluid access points, luer threads, etc.). In this way, sufficient contact between the cleaning surface of the capping and cleaning device and the surface of the needleless connector to be cleaned can be ensured. Another advantage of some synthetic foams (and certain other polymeric materials that may form the substrate) is that they can be easily injected into a shell or casing at a desired volume during manufacture, after which they expand to assume a desired substrate size, density, porosity, etc.

In addition, the compressible cleaning matrix may include chemicals to indicate a functional change therein, for example, by using a color change to signify a change from a wet to a dry state, or, alternatively, the matrix material has been properly wetted by a healthcare worker with a liquid cleaning agent dispersed into the substrate prior to use (rather than during manufacture of the device). Thus, depending on the system used, the color change of the substrate can be used to indicate that the cleaning agent in the compressible cleaning substrate has evaporated prior to use (possibly due to leakage from the storage container of the capping and cleaning device) and that the particular cleaning device should not be used. Alternatively, when using a colored liquid cleaning agent, for example, the user can visually confirm the dispersion of the agent in the matrix by assessing whether the colored cleaning agent is dispersed throughout the matrix. When a coloured cleaning agent is used, it is preferred that the material used to make the resilient inner body and/or the cap of the capping and cleaning device is transparent or translucent, or comprises one or more transparent or translucent windows, so as to allow any colour change to be readily observed before or during use of the capping and cleaning device.

The capping and cleaning devices of the present invention and their components (e.g., resilient inner body, cap, compressible cleaning matrix, sealing ring, seal, etc.) may be made of any suitable material and assembled using any suitable process.

Preferably, the outer surface of the outer housing of the capping and cleaning device intended to be gripped by the user has a non-slip surface (i.e., a surface with a high coefficient of friction) such that when the outer portion of the capping and cleaning device is held in the user's fingers and positioned to clean the needleless connector, the outer housing can rotate relative to the inner housing and the needleless connector with minimal or no slip between the device and the user's fingers (gloved or ungloved). Examples of such non-slip (or high friction) surfaces include those having ridges, valleys, dimples, ridges or other features designed to enhance friction, as well as combinations of two or more of these features. These features may be introduced into the outer surface of the device as part of the manufacturing process. Alternatively, a non-slip coating may be applied to one or more of the outer surfaces of the outer housing.

Generally, the capping and cleaning device of the present invention is provided to the user in a sealed, sterile manner. Label information, logos, artwork, manufacturing and/or regulatory data (e.g., lot number, expiration date or "use date", etc.) may also be printed or otherwise applied to the respective capping and cleaning devices, if desired. In addition, information such as bar codes (e.g., to allow for tracking of the use of the device) may also be included on the respective capping and cleaning devices.

It will be appreciated that the cleaning device may be packaged individually or in sets of two or more units, which may further include instructions for use of the capping and cleaning devices, as well as other information, logos, illustrations, manufacturing, and/or regulatory data.

In a preferred embodiment, the lidding and cleaning devices of the packages are sterilized using a suitable process, such as irradiation. In a particularly preferred practice, the capping and cleaning device of the present invention is sterilized as part of the manufacturing process. Here, "sterilization" refers to any process effective to kill or eliminate transmissible agents (e.g., bacteria, viruses, fungi, prions, spores, etc.) that may be present in any component of a device according to the present invention. In a preferred embodiment, sterilization may be accomplished by heat, chemical treatment, irradiation, and other processes. Indeed, any sterilization process compatible with the materials used to manufacture the capping and cleaning devices may be employed. A particularly preferred sterilisation process is an irradiation process. Such processes include irradiation with X-rays, gamma rays, or sub-atomic particles (e.g., electron beams). Generally, when a germicidal process is used in the context of the present invention, the process is employed on a cleaning article after it has been sealed and/or packaged. Chemical sterilization processes, such as sterilization using ethylene oxide (EtO), may also be used.

The present invention also relates to methods of using the instant single use capping and cleaning devices of the present invention. Such methods include using the device for cleaning and, if desired, capping a needleless connector (such as a needleless connector, a luer access device, etc.). To perform such a method, typically after a user (e.g., a nurse) removes a seal across an opening in the device, a portion of the needleless connector to be cleaned is screwed into the central bore of the inner housing of the capping and cleaning device. This insertion brings the portion of the needleless connector into contact with (i.e., into cleaning association with) the compressible cleaning substrate portion of the device. In preferred practice, once the compressible cleaning substrate comes into contact with the surface of the needleless connector to be cleaned, the outer housing automatically disengages the engagement elements in the inner and outer housings to allow the outer housing to rotate relative to the inner housing and the needleless connector previously releasably connected to the capping and cleaning device. This contacting and cleaning action may last for any desired period of time, with a period of about one second to about ten to twenty seconds being particularly preferred.

After cleaning, the needleless connector can be removed from the capping and cleaning device, after which the capping and cleaning device can be discarded. Alternatively, after cleaning, the capping and cleaning device may remain attached to the needleless connector, capping a portion thereof until such time as access to the needleless connection is desired, thereby capping it and protecting it from contamination. At that point, the capping and cleaning device may be removed and discarded. If desired, the cleaning process can be repeated just prior to removal.

Immediately after removing the capping and cleaning device from the cleaned needleless connector, a medical reservoir containing a fluid (e.g., a syringe containing a medication, an IV bag, etc.) may be connected to the cleaned needleless connector. In preferred embodiments where the cleaning agent is a solution, the surface of the needleless connector is preferably allowed to dry (or dried) prior to connecting the needleless connector to the reservoir, for example by wiping with a sterile absorbent cloth or wipe, which may be dry or wetted with a volatile, compatible solution (e.g., 70-100% alcohol). In preferred practice, this cleaning method results in at least a 2-fold, 5-fold, or 10-fold or more reduction in microbial contamination on the accessible surfaces that have been cleaned. Even more preferably, the level of reduction of microbial contamination reduction on the accessible joint surface may be more than 100-fold, 10-fold³10 times of⁴10 times of⁵10 times of⁶Multiple or 10 times⁷And (4) doubling.

In addition to methods for cleaning accessible surfaces of luer access devices and the like, the devices of the present invention also provide methods of reducing the risk of infection in a patient connected to a device configured to deliver fluid directly into the bloodstream of the patient, such as a peripheral IV line, a central IV line, or a peripherally inserted central catheter. The risk reduction provided by the device of the present invention may vary depending on a number of factors, such as the age and condition of the patient, the condition being treated, the location where the medical services are provided, the density of the patient, the level of contaminating microorganisms in the environment, the quality of the air handling equipment in the medical facility, the level of training on the medical personnel responsible for cleaning the access device, the method used to periodically clean the medical connectors, the spacing between cleaning procedures, the particular configuration of the capping and cleaning devices, the particular configuration of the needleless connector, whether the capping and cleaning devices are left in the cleaned portion of the needleless connector to provide capping, and the like. Any suitable method may be used to reduce the risk, for example by assessing the HAI frequency with and without the use of the cleaning device according to the invention. It is expected that by using capping and cleaning devices according to the present invention, the risk of HAI infection will be reduced by 1-100% or more (including up to 1000% or more). It will be appreciated that a reduction in the risk of infection (e.g., risk of HAI) will translate into improved patient outcomes (through reduced morbidity and mortality) and reduced expenditure for treatment of HAI.

Representative examples

To further illustrate and describe certain preferred and representative embodiments of the present invention, the reader is referred to the accompanying drawings (fig. 1-10), which illustrate various particularly preferred embodiments of the capping and cleaning devices of the present invention. A description of these preferred, representative embodiments follows.

Fig. 1 shows several views ((a) - (g)) of a representative capping and cleaning device (10) of the present invention, its constituent parts (views (b) - (g)), and the device associated with the needleless connector (view (a)). The component parts include a lid having a lid portion (11) adapted to receive and retain a compressible cleaning substrate (80) and a resilient inner body (30), the resilient inner body (30) being associated with the lid portion (11) and adapted to engage one or more complementary features of the lid portion to prevent the lid portion and the resilient inner body from moving independently of one another under certain conditions and to allow the lid portion (11) and the resilient inner body to move independently of one another under other conditions. For example, after attaching the device (10) to the needleless connector (100) (resulting in a capped needleless connector (200)), a user may compress the resilient inner body (30) of the device (10) by applying pressure to compress the cap (10) against the needleless connector (100) so as to allow the cap (10) to rotate relative to the resilient inner body (30) and the needleless connector (100). This action brings the compressible cleaning substrate (80) into contact with a surface of the needleless connector (100) that is desired to be cleaned (e.g., a valve surface of a needleless medical valve), and rotation of the cap (10) relative to the needleless connector (100) can generate friction that can damage, for example, a biofilm that may be present on the valve surface of the needleless medical valve (which surface can be in the fluid path of fluid moving through the medical valve).

Fig. 2(a) is an exploded view of a representative capping and cleaning device (10) and needleless connector (100) of the present invention. Visible are: a cover (10) including a cover portion (11) thereof, a compressible cleaning substrate (80) and a resilient inner body (30) being positioned in the cover portion (11); and a luer-based needleless connector (100) as a needleless medical valve, the male end (105) of which has a collar (101) and a thread (102) for connecting the valve to the female threaded portion of a complementary luer fitting of another needleless connector (not shown). View (b) is a cross-sectional side view of the cap (10) shown in view (a) while it is still sealed with the seal (90). As shown, the lid portion (11), compressible cleaning substrate (80), and resilient inner body (30) are operably assembled. The compressible cleaning substrate (80) is preferably positioned in a substrate well (12) formed in the lid portion (11) and protruding from an inner surface of the lid portion (11). The height of the substrate well (12) should allow for retention of a compressible cleaning substrate (80) and, in some embodiments, may be sized to act as a stop that may bear against a collar of the needleless connector (100) to which the cap is attached when the cap is compressed and rotated by a user to clean a desired surface of the needleless connector (100).

Views (c) and (d) of fig. 2 show cap (10) threaded onto medical valve (100) in a capped and cleaned configuration (views (c) and (d), respectively). As these views show, the compressible cleaning matrix (80) of the cap (10) bears against the valve surface of the valve stem portion (103) of the medical valve (100). In the capped view (c)), the cap (and compressible cleaning matrix (80)) is uncompressed. The diameter of the substrate well (12) allows the cap to slide over the threads (102) of the medical valve (100) when a user who wishes to clean the surface of the valve stem portion (103) pushes the cap toward the medical valve (100). View (d) shows the cap (10) compressed against the medical valve (100). The user-induced compression causes the cap portion (11) to move closer to the body of the medical valve (100) by virtue of the compression of the resilient inner body (30) and the compressible cleaning matrix (80). This movement also causes the complementary mechanical retention elements of the cap portion (11) and the resilient inner body (30) to disengage, thus allowing the user to rotate the cap portion (11) and the compressible cleaning substrate (80) of the cap relative to the valve surface, thereby allowing the surface to be cleaned.

Figure 3 shows six different views of a representative capping and cleaning device of the present invention. Views (a) - (c) show the device (10) in a static, non-compressed, non-rotated position, in which the cover portion (11) and the resilient inner body (30) are engaged such that the cover (10), and hence the compressible cleaning substrate (80) associated therewith, cannot rotate relative to the resilient inner body (30) of the device. Views (d) - (f) show the same representative device (10) with the lid portion (11) and the resilient inner body (30) in a moveable relationship such that the lid portion (11) and the compressible cleaning substrate (80) associated therewith can be rotated relative to the resilient inner body (30) of the device. The inner surface of the resilient inner body (30) includes one or more (preferably two) tabs (35) to engage the threads of the needleless connector (100). In the embodiment shown in the figures, the outer surface of the resilient inner body (30) includes a plurality of teeth (33) or other structures spaced around the outer circumference of the resilient inner body that are designed to engage complementary spaced structures (e.g., ribs (18)) spaced on the inner surface of the lid portion (11). When the lid (10) is uncompressed, the teeth (33) engage the ribs (18) and effectively lock the lid portion (11) and the resilient inner body (30) together so that they rotate together. This enables the cap (10) to be screwed onto a complementary luer of a needleless connector, for example using tabs (35) on the inner surface of the resilient inner body (30), to provide a capping function (to remove the cap from the needleless connector, the process being reversed). To provide a cleaning action, once secured to the needleless connector, the cap (10) may then be compressed by the user, which pushes the cap portion (11) towards the junction of the needleless connector and compresses the compressible cleaning substrate (80) against the surface of the connector (100) to be cleaned.

Figure 4 shows a view of the lid portion (11) of a representative capping and cleaning device (10) of the present invention. View (a) shows a top view of the lid portion (11). Also visible on portions of the outer surface of the lid portion (11) are ridges and valleys that provide enhanced friction, allowing a user to better grip or grasp the lid (10). View (b) shows a side view of the lid portion (11). View (c) shows a bottom view of the lid portion (11). Visible in this embodiment are six ribs (or projections) (18) evenly spaced around the circumference of the inner surface of the lid portion (here about 60 degrees centered). The ribs (18) are positioned and dimensioned to engage complementary features on the outer surface of the resilient inner body (30) (not shown). The walls forming the matrix wells (12) are also visible in this view. View (d) shows a cross-sectional view of the lid part (11). A well (20) formed by a substrate well wall (12) extending from an inner surface of an upper portion of the lid portion (11) is also present and adapted to receive and retain a compressible cleaning substrate (80). In a preferred embodiment, an adhesive (not shown) or other bonding agent is used to bond the compressible cleaning matrix (80) within the well (20). The well (20) is spaced from the outer wall of the lid portion (11). The resulting space is sized and adapted for insertion of the resilient inner body (30), the lid portion (11) being rotatable about the resilient inner body (30) upon complementary retaining elements (e.g., ribs (18) and teeth (33)) of the lid portion (11). In the representative embodiment of the capping and cleaning device (10) of the present invention depicted in the figures, the upper surface (19) of the retaining element (18) present in the lid portion (11) is designed to engage the lower surface of the locking groove (34) between the teeth (33).

Fig. 5 shows seven different views ((a) - (g)) of the resilient inner body (30) of a representative capping and cleaning device (10) of the present invention. Representative measurements for this particular embodiment are shown in several views. Depicted in this embodiment are two threaded tabs (35) disposed on the inner surface of the wall (36) of the resilient inner body (30) for engaging 12 spaced apart teeth (33) of 12 complementary retaining elements (e.g., ribs (18)) on the inner surface of the lid portion (11). The resilient inner body (30) is adapted to be compressed by a user upon application of a suitable force and to rebound upon release of such pressure.

Fig. 6 shows five different views ((a) - (e)), three of which show the compressible cleaning substrate portion (80) of a representative capping and cleaning device (10) of the present invention. Views (a) - (c) show top, side and bottom views of this particular compressible cleaning substrate (80). Preferably, the compressible cleaning matrix (80) is bonded to the surface of the matrix well (20) of the lid portion (11) using an adhesive. Views (d) and (e) of fig. 6 show bottom and side views of the sealing portion (90) of a representative capping and cleaning device of the present invention. The seal (90) is typically sized to seal or cover the opening that allows access to the interior of the lid (10). Preferably, the seal comprises one or more removable tabs (91) configured to allow a user to grasp so that the seal can be removed immediately before the device is used to cap and/or clean the needleless connector (100). Preferably, the seal is bonded to the lid (10) using a suitable adhesive (94) applied to the inner surface (92) of the seal (90). The outer surface (93) of the seal will typically contain alphanumeric characters, bar code information, and the like.

Fig. 7 (fig. 7A-7E) show five different views of another representative capping and cleaning device (300) of the present invention, in which a user engages the inner and outer housings (320, 301) by squeezing (or applying pressure using two or more fingers) the outer housing (301), slightly deforming it and moving the inner housing engagement elements (311) present on the inner surface of the side walls of the outer housing such that one or more of them (typically on opposite sides of the outer housing (301)) engage the outer housing engagement elements (326) present on the outer surface of the inner housing (320) below the inner housing retaining elements (322) on the outer surface of the inner housing side walls (321). The top of the outer housing (309) is integral with the side wall (302) of the outer housing. Fig. 7A shows an exploded perspective view of the device (outer housing (301), compressible cleaning substrate (305), and inner housing (320)) and the NC (100) to which the device (300) is to be connected (see fig. 7B, 7E). The NC (100) has a threaded valve area (105) comprising a collar (101) located below the threaded portion (102). A valve surface (110) is disposed on top of the threaded valve region (105). In fig. 7A-7E, the valves are not depicted.

Fig. 7B shows a perspective view of the assembly device (300) depicted in fig. 7A secured to the threaded region of the valve portion (105) of the NC (100) depicted in fig. 7A. Preferably, the plastic used to injection mold the outer housing (301) of the device (300) shown in this embodiment is softer than the plastic used to mold the inner housing (302). Preferably, the plastic used to form the outer housing is sufficiently flexible to allow it to be squeezed by a user to allow engagement between the engagement elements (326, 311) of the inner and outer housings for attaching and removing the device (300) to and from the NC (100), but sufficiently resilient to allow the outer housing (301) to return to its original shape to allow the engagement elements (326, 311) of the inner and outer housings to disengage. This allows a user to rotate the outer housing (301) and substrate 305) relative to the NC (100) in order to clean its valve surface (110) when performing a cleaning operation, for example by rotating the device (300) without engaging elements (326, 311) of the inner and outer housings for a sufficiently long period of time (e.g., 1-15 seconds or more) and/or for a desired amount of rotation (e.g., 360 to 3,600 degrees or more) in the same or different directions.

Fig. 7C shows an exploded cross-sectional view of the component depicted in fig. 7A. Further, a thin, flexible lip seal (324) with a tapered profile integrated into the top surface of the inner housing (320) is designed to engage with the sealing surface (308) of the bottom of the substrate well, which includes a substrate cavity (303) into which the substrate retention rib (307) protrudes and allows the rotational force applied by the user to the device (300) to be transferred to the compressible cleaning substrate (305). The threads (326) on the inner surface of the inner housing (320) are designed to engage with complementary threads (102) in the threaded region (105) of the NC (100).

It should be understood, and as shown in fig. 7C-7E, that the compressible cleaning matrix (305) is inserted into the matrix well (303) during manufacture. The substrate (305) may be impregnated with a cleaning agent (e.g., silver ions) and, in a preferred embodiment, a liquid disinfectant, such as a 70% IPA solution. A bearing surface (323) of an outer housing retaining element (322), here a tapered flange moulded as part of the inner housing (320) during manufacture, is designed to ride over a complementary bearing surface (310) provided on the inner surface of the main cavity (304) of the outer housing. An inner housing retaining element (306) of the outer housing (301) is used to retain the inner housing (320) in the main cavity (304) of the outer housing after the inner and outer housings are assembled into a functional subassembly during manufacture. For example, the inner housing may be pushed into the outer housing with sufficient force to join them into a functional subassembly ready for insertion of the compressible cleaning substrate (305), followed by instillation of a liquid sterilant (e.g., 70% IPA solution), sealing, packaging, and sterilization. An inner housing engagement element (311) present on an inner surface of a sidewall (302) of the outer housing allows the outer housing (302) to engage an outer housing engagement element (326) on an adjacent outer surface of the inner housing (320).

Fig. 7D (cross-sectional view) shows the components of the device of the present invention (outer housing (301), compressible cleaning substrate (305) and inner housing (320)) assembled into a functional capping and cleaning device (300) ready for attachment to the threaded region of the valve portion (105) of the NC depicted in fig. 7A. When the device (300) is attached to the NC (100), the NC-contacting surface of the substrate (305) contacts the valve surface (110) of the NC, allowing the surface to be cleaned by a user rotating the device (300) relative to the NC. Fig. 7E is a cross-section showing a capping and cleaning device (300) of the present invention, the capping and cleaning device (300) being screwed onto the NC, which results in compression of the compressible cleaning substrate (305) against the valve surface (110) of the NC.

Fig. 8 (fig. 8A-8E) shows five different views of another representative capping and cleaning device of the present invention. This embodiment is similar to the embodiment depicted in fig. 7 (fig. 7A-7E), except that in the embodiment shown in fig. 8, the seal is not a lip seal (324) on the inner housing (320), but rather is a tapered downwardly extending seal (408) disposed on the bottom surface of the components forming the substrate well (403) in the outer housing (401).

Fig. 8A shows an exploded perspective view of an embodiment of the device (400) (outer housing (401), compressible cleaning substrate (405), and inner housing (420)) and NC (100) to which the device (400) is to be attached (see fig. 8B, 8E). Fig. 8B shows a perspective view of the assembly device (400) depicted in fig. 8A secured to the threaded area of the valve portion (105) of the NC depicted in fig. 8A. Fig. 8C shows an exploded cross-sectional view of the components depicted in fig. 8A, while in fig. 8D, the cross-sectional view shows the components of the device of the present invention (outer housing, compressible cleaning substrate and inner housing) assembled into a functional capping and cleaning device ready for attachment to the threaded region of the valve portion of the NC depicted in fig. 8A. Figure 8E is a cross-sectional view showing the capping and cleaning device of the present invention threaded onto the NC, which results in compression of the compressible substrate against the valve surface of the NC.

Specifically, fig. 8 (fig. 8A-8E) shows five different views of another representative capping and cleaning device (400) of the present invention in which a user engages the inner and outer housings (420, 401) by squeezing (or applying pressure using two or more fingers) the outer housing (401), slightly deforming it and moving the inner housing engagement elements (411) present on the inner surface of the side walls of the outer housing so that one or more of them (typically on opposite sides of the outer housing (401)) engage the outer housing engagement elements (426) present on the outer surface of the inner housing (420) below the inner housing retention elements (422) on the outer surface of the inner housing side walls (421). The top of the outer shell (409) is integral with the side walls (402) of the outer shell. Fig. 8A shows an exploded perspective view of the device (outer housing (401), compressible cleaning substrate (405), and inner housing (420)) and the NC (100) to which the device (400) is to be connected (see fig. 8B, 8E). The NC (100) has a threaded valve region (105) which includes a collar (101) below its threaded portion (102). A valve surface (110) is disposed on top of the threaded valve region (105). In fig. 8A to 8E, the valve of the NC (100) is not depicted.

Fig. 8B shows a perspective view of the assembly device (400) depicted in fig. 8A secured to the threaded region of the valve portion (105) of the NC (100) depicted in fig. 8A. Preferably, the plastic used to injection mold the outer housing (401) of the device (400) shown in this embodiment is softer than the plastic used to mold the inner housing (402). Preferably, the plastic used to form the outer housing is sufficiently flexible to allow it to be squeezed by a user to allow engagement between the engagement elements (426, 411) of the inner and outer housings for attaching and removing the device (400) to and from the NC (100), but sufficiently resilient to allow the outer housing (401) to return to its original shape to allow the engagement elements (426, 411) of the inner and outer housings to disengage. This allows a user to rotate the outer housing (401) and substrate (405) relative to the NC (100) in order to clean its valve surface (110) when performing a cleaning operation, e.g., by rotating the device (400) without engaging the engagement elements (426, 411) of the inner and outer housings for a sufficiently long period of time (e.g., 1-15 seconds or more) and/or for a desired amount of rotation (e.g., 360 to 3,600 degrees or more) in the same or different directions.

Fig. 8C shows an exploded cross-sectional view of the component depicted in fig. 8A. In this embodiment (400), a tapered, downwardly extending sealing element (408) is provided on the bottom surface of the component forming the substrate well (403) in the outer housing (401). The seal (408) has a sealing surface 409, the sealing surface 409 being designed to seal against a sealing surface (423) of a conical flange of a holding element (422) of the inner housing (420). As with the embodiment depicted in fig. 7, the embodiment depicted in fig. 8 is tapered so as to allow the inner housing to be easily assembled with the outer housing (401), for example, by applying sufficient pressure to the components to expand the pliable, resilient outer housing sufficiently to allow the inner housing (420) to be inserted into the main cavity (404) of the outer housing to the point where the bearing surfaces (424) of the retention elements (422) of the inner housing exceed the inner housing retention elements (406) of the outer housing, at which point the outer housing (401) contracts and the bearing surfaces (424, 410) of the retention elements (422, 406) of the inner and outer housings come into contact to prevent the inner housing (420) from being pulled out of the main cavity (404) of the outer housing, and to provide a smooth interface that allows for easy, if and when desired, between the inner and outer housings (420, 401), Low friction rotation.

It should be understood, and as shown in fig. 8C-8E, that the compressible cleaning matrix (405) is inserted into the matrix well (404) during manufacture. The substrate (405) may be impregnated with a cleaning agent (e.g., silver ions) and, in a preferred embodiment, a liquid disinfectant (such as a 70% IPA solution). A bearing surface (424) of an outer housing retaining element (422), here also a tapered flange moulded as part of the inner housing (420) during manufacture, is designed to ride over a complementary bearing surface (410) provided on the inner surface of the main cavity (404) of the outer housing. An inner housing retaining element (411) of the outer housing (401) is used to retain the inner housing (420) in the main cavity (404) of the outer housing after assembly of the inner and outer housings into a functional subassembly during manufacture. For example, the inner housing may be pushed into the outer housing with sufficient force to join them into a functional subassembly ready for insertion of the compressible cleaning substrate (405), followed by instillation of a liquid sterilant (e.g., 70% IPA solution), sealing, packaging, and sterilization. An inner housing engagement element (411) present on an inner surface of a sidewall (402) of the outer housing allows the outer housing (402) to engage an outer housing engagement element (426) on an adjacent outer surface of the inner housing (420).

Fig. 8D (cross-sectional view) shows the components of the device of the present invention (outer housing (401), compressible cleaning substrate (405), and inner housing (420)) assembled into a functional capping and cleaning device (400) ready for attachment to the threaded region of the valve portion (105) of the NC depicted in fig. 8A. When the device (400) is attached to the NC (100), the NC-contacting surface of the substrate (405) contacts the valve surface (110) of the NC, allowing the surface to be cleaned by a user rotating the device (400) relative to the NC. Fig. 8E is a cross-section showing a capping and cleaning device (400) of the present invention, the capping and cleaning device (400) being screwed onto the NC, which results in compression of the compressible cleaning substrate (405) against the valve surface (110) of the NC.

Fig. 9 (fig. 9A-9E) shows five different views of another representative capping and cleaning device of the present invention. This embodiment is similar to the embodiment depicted in fig. 8 (fig. 8A-8E), except that in the embodiment shown in fig. 9, the outer housing (501) has a different external configuration than the embodiment depicted in fig. 8. Here, the side wall (502) forming part of the structure of the device (500) has a step therein, giving it a layered "wedding cake" appearance in outline. To make the device (500) easy for the user to grip, a series of external ribs (535) are provided at the upper portion of the exterior of the outer housing.

Specifically, fig. 9 (fig. 9A-9E) shows five different views of another representative capping and cleaning device (500) of the present invention in which a user engages the inner and outer housings (520, 501) by squeezing (or applying pressure using two or more fingers) the outer housing (501), slightly deforming it and moving the inner housing engagement elements (511) present on the inner surface of the sidewall of the outer housing so that one or more of them (typically on opposite sides of the outer housing (501) engage the outer housing engagement elements (526) present on the outer surface of the inner housing (520) below the inner housing retention elements (522) on the outer surface of the inner housing sidewall (521)). The top of the outer housing (509) is integral with the side walls (502) of the outer housing. Fig. 9D shows an exploded perspective view of the device (outer housing (501), compressible cleaning substrate (505), and inner housing (520)) and the NC (100) (see fig. 9B, 9C) to which the device (500) is to be connected. The NC (100) has a threaded valve region (105) which includes a collar (101) below its threaded portion (102). A valve surface (110) is disposed on top of the threaded valve region (105). In fig. 9A to 9E, the valve of the NC (100) is not depicted.

Fig. 9A shows a perspective view of the assembly device (500) depicted in fig. 9D secured to the threaded region of the valve portion (105) of the NC (100) depicted in fig. 9A. Preferably, the plastic used to injection mold the outer housing (501) of the device (500) shown in this embodiment is softer than the plastic used to mold the inner housing (502). Preferably, the plastic used to form the outer housing is sufficiently flexible to allow it to be squeezed by a user to allow engagement between the engagement elements (526, 511) of the inner and outer housings for attaching and removing the device (500) to and from the NC (100), but sufficiently resilient to allow the outer housing (501) to return to its original shape to allow the engagement elements (526, 511) of the inner and outer housings to disengage. This allows a user to rotate the outer housing (501) and substrate (505) relative to the NC (100) in order to clean its valve surface (110) when performing a cleaning operation, for example, by rotating the device (500) without engaging the engagement elements (526, 511) of the inner and outer housings for a sufficiently long period of time (e.g., 1-15 seconds or more) and/or for a desired amount of rotation (e.g., 360 to 3,600 degrees or more) in the same or different directions.

Fig. 9D shows an exploded cross-sectional view of the components depicted in fig. 9A-9C. In this embodiment (500), a tapered, downwardly extending sealing element (508) is provided on the bottom surface of the component forming the substrate well (503) in the outer housing (501). The seal (508) has a sealing surface 509, the sealing surface 509 being designed to seal against a sealing surface (523) of a tapered flange of a retaining element (522) of an inner housing (520). As with the embodiments depicted in fig. 7 and 8, the embodiment depicted in fig. 9 is tapered to allow the inner housing to be easily assembled with the outer housing (501), for example, by applying sufficient pressure to the components to expand the pliable, resilient outer housing sufficiently to allow the inner housing (520) to be inserted into the main cavity (504) of the outer housing to the point where the bearing surfaces (524) of the retention elements (522) of the inner housing exceed the inner housing retention elements (506) of the outer housing, at which point the outer housing (401) contracts and the bearing surfaces (524, 510) of the retention elements (522, 506) of the inner and outer housings come into contact to prevent the inner housing (520) from being pulled out of the main cavity (504) of the outer housing, and to provide a smooth interface that allows for easy, if and when desired, between the inner and outer housings (520, 501), Low friction rotation.

It should be understood, and as shown in fig. 9B-9E, that a compressible cleaning matrix (505) is inserted into the matrix well (504) during manufacture. The substrate (505) may be impregnated with a cleaning agent (e.g., silver ions) and, in a preferred embodiment, a liquid disinfectant (such as a 70% IPA solution). A bearing surface (524) of an outer housing retaining element (522), here also a tapered flange molded as part of the inner housing (520) during manufacture, is designed to ride over a complementary bearing surface (510) provided on an inner surface of a main cavity (504) of the outer housing. An inner housing retaining element (511) of the outer housing (501) is used to retain the inner housing (520) in the main cavity (504) of the outer housing after the inner and outer housings are assembled into a functional subassembly during manufacture. For example, the inner housing may be pushed into the outer housing with sufficient force to join them into a functional subassembly ready for insertion of the compressible cleaning substrate (505), followed by instillation of a liquid sterilant (e.g., 70% IPA solution), sealing, packaging, and sterilization. An inner housing engagement element (511) present on an inner surface of a sidewall (502) of the outer housing allows the outer housing (501) to engage an outer housing engagement element (526) on an adjacent outer surface of the inner housing (520).

Fig. 9D (cross-sectional view) shows the components of the device of the present invention (outer housing (501), compressible cleaning substrate (505), and inner housing (520)) assembled into a functional capping and cleaning device (500) ready for attachment to the threaded region of the valve portion (105) of the NC. When the device (500) is attached to the NC (100), the NC-contacting surface of the substrate (505) contacts the valve surface (110) of the NC, allowing the surface to be cleaned by a user rotating the device (500) relative to the NC. Fig. 8E is a cross-section showing a capping and cleaning device (500) of the present invention, the capping and cleaning device (500) being screwed onto the NC, which results in compression of the compressible cleaning substrate (505) against the valve surface (110) of the NC.

Fig. 10 shows three different cross-sectional views of another representative capping and cleaning device (600) of the present invention, wherein the outer housing (601) is pushed upward by the compressible cleaning matrix (605) as the device (600) is threaded onto the threaded valve region (105) of the needleless connector (100). This upward movement places the outer housing (601) in a neutral position in which the engagement elements (611, 626) of the outer and inner housings (601, 620) are disengaged, thereby allowing the outer housing (601) to rotate relative to the inner housing (620). Fig. 10B and 10C show the device (600) fixed to the threaded area of the valve portion (105) of the NC, while fig. 10A shows the device (600) disconnected from the NC (100). Figure 10B shows the outer housing of the device in a neutral position (the engagement elements of the inner and outer housings are not engaged) from which the user can rotate the outer housing (and compressible cleaning substrate) relative to the NC to which the inner and inner housings are secured. It will be appreciated that the compressible cleaning substrate (605) may act as a spring or biasing element which, in the absence of sufficient downward reaction force, pushes the outer housing (601) upwardly relative to the inner housing (620), thereby allowing the user to rotate the outer housing (and compressible cleaning substrate) relative to the inner housing (620) and NC (if and when desired). Without such rotation, the capping and cleaning device (600) of the present invention, when connected to the NC, acts as a cap to protect the threaded valve area (105) of the NC from environmental contamination, including microbial contamination. Fig. 10C depicts the device (600) when the engagement elements (626, 611) of the inner and outer housings (620, 601) engage, allowing the device to be screwed onto or off the NC (100).

In the embodiment depicted in fig. 10, the device (600) further comprises a seal (630) disposed on an outer surface of the inner housing (620). The purpose of this seal is to prevent liquid cleaning agent from being quickly lost from the device after it is attached to the NC, as it is preferred that the device according to the invention can remain attached to the NC for up to 7 or more days.

It should be appreciated that in fig. 7-10, the lower surface (340, 440, 540, 640) of the sidewall of the outer housing (301, 401, 501, 601) is a surface adapted to receive a lid or seal (not shown) to seal the interior space of the device (300, 400, 500, 600) from the external environment. This not only allows for the preservation of the cleaning agent in the compressible cleaning matrix (320, 420, 520, 620) until the particular device is used to cap and/or clean the needleless connector, but also maintains the sterility of the device.

In the foregoing specification and the appended claims, the words "comprise", "comprising", and the like, are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense, unless the context clearly requires otherwise; that is, in the sense of "including, but not limited to". Words using the singular or plural number also include the plural or singular number, respectively. Additionally, "herein," "below," "above," "below," and words of similar import refer to this application as a whole and not to any particular portions of this application. When the word "or" is used to refer to a list of two or more items, the word encompasses all of the following interpretations of the word: any item in the list, all items in the list, and any combination of items in the list.

The foregoing description, for purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. Accordingly, the invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims, and is intended to be limited only by the scope of the applicable legal rules.

Claims

1. A capping and cleaning device for a needleless vascular access connector having a threaded valve portion, the device comprising:

(a) an inner housing configured to allow the device to be screwed onto and off of the threaded valve portion of the needleless vascular access connector;

(b) an outer housing comprising a cavity in which the inner housing is disposed, wherein the outer housing is configured to retain and engage the inner housing but is rotatable independently of the inner housing when the outer housing is not engaged with the inner housing; and

(c) a compressible cleaning matrix held in and rotating with the outer housing, the matrix optionally impregnated with a disinfectant, optionally a 70% isopropyl alcohol solution.

2. The device of claim 1, further comprising a removable seal for sealing the interior of the device from the external environment.

3. The device of claim 1, wherein the cleaning agent comprises isopropyl alcohol, optionally a 70% isopropyl alcohol solution.

4. The device of claim 1, wherein the outer housing comprises an outer surface having a plurality of vertical ridges.

5. A method of cleaning a needleless vascular access connector, comprising:

(a) connecting a needleless vascular access connector to the capping and cleaning device of claim 1 such that one or more surfaces of the connector engage and at least partially compress the compressible cleaning substrate; and

(b) if necessary, the outer housing is rotated relative to the inner housing and connector to clean the surface of the connector in contact with the compressible cleaning substrate.

6. The method of claim 2, further comprising leaving the needleless connector connected to the capping and cleaning device after cleaning, thereby capping the needleless connector.

7. A capping and cleaning device for a needleless vascular access connector having a threaded valve portion, the device comprising:

(a) an inner housing, comprising: a generally cylindrical sidewall forming a central bore that is open at its top and bottom ends, wherein disposed on an inner surface of the central bore proximate the bottom opening is one or more threaded engagement tabs or threads configured to engage a threaded valve portion of a needleless vascular access connector to retain, and if and when desired, release the needleless connector; an outer housing engagement area configured to allow mechanical engagement with and disengagement from an outer housing of the apparatus; and optionally an outer housing retention area configured to allow retention of the inner housing in the cavity of the outer housing and rotation of the outer housing relative to the inner housing when the outer housing engagement area is disengaged;

(b) an outer housing, comprising: a cavity formed by an outer wall and a top wall; optionally a concentric matrix well; one or more engagement and retention structures configured to releasably engage and retain the inner housing in the cavity, wherein the inner and outer housings are rotatable in unison when the engagement structures engage the inner housing, and wherein the outer housing is rotatable relative to the inner housing when the engagement structures disengage from the inner housing; and

(c) a compressible cleaning matrix comprising a cleaning agent disposed therein and secured in a matrix well of the outer housing, wherein the matrix is configured to contact and clean one or more surfaces of a needleless vascular access connector when the device is secured to the connector and the outer housing and matrix are rotated relative to the inner housing, wherein the cleaning agent is optionally a 70% isopropyl alcohol solution.

8. The device of claim 7, further comprising a removable seal for sealing the interior of the device from the external environment.

9. The apparatus of claim 7, wherein the cleaning agent comprises isopropanol, optionally a 70% isopropanol solution.

10. The device of claim 7, wherein the outer housing includes an outer surface having a plurality of vertical ridges.

11. A method of cleaning a needleless vascular access connector, comprising:

(a) connecting a needleless vascular access connector to the capping and cleaning device of claim 7 such that one or more surfaces of the connector engage and at least partially compress the compressible cleaning substrate; and

12. The method of claim 11, further comprising leaving the needleless connector connected to the capping and cleaning device after cleaning, thereby capping the needleless connector.