Disinfection cap for fluid path element

Abstract

A disinfection cap is provided for a fluid path element having an inner lumen and an outer cylindrical wall surrounding the inner lumen. The disinfection cap includes a housing configured to receive the inner lumen and the outer cylindrical wall of the fluid path element. The housing has an open proximal end, a closed distal end, and a side wall extending between the open proximal end and the closed distal end and defining an internal volume. A sleeve projects proximally from the inner surface of the closed distal end and defines an opening configured to receive the inner lumen of the fluid path element. A compressible absorbent material at least partially saturated with a disinfection fluid is disposed within the internal volume of the housing and surrounds at least a portion of the sleeve.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 351,882, filed on June 14, 2022, and U.S. Provisional Application No. 63 / 409,300, filed on September 23, 2022, the disclosures of which are hereby incorporated by reference in their entirety.

[0002] The present disclosure generally relates to mechanisms associated with multiple - patient fluid path elements for powered medical fluid injection systems, and more particularly, to caps for fluid path elements that prevent contamination by microbial contaminants before and during continuous fluid injection procedures that utilize a common set of multiple - patient fluid paths.

Background Art

[0003] Syringe injection systems are among the medical devices used in medical imaging procedures. To reduce the number of disposable components during a series of fluid injections, the system may incorporate multiple - patient parts such as a multiple - patient pump system and multiple - patient fluid path elements that can be used over a series of fluid injection procedures, and single - patient fluid path elements that include associated check valves and are used only for a single injection procedure and then discarded and replaced with a new sterile single - patient fluid path element for subsequent fluid injection procedures.

[0004] For use in medical procedures, several syringe-based or peristaltic pump-based powered injectors have been developed, such as angiography (CV), computed tomography (CT), and nuclear magnetic resonance (NMR) / magnetic resonance imaging (MRI). Some of these powered injectors may include options for use in a multi-patient configuration that utilizes multiple patient components and single patient components. An example of such a system is the Bayer MEDRAD® Centargo CT Fluid Injection System, which includes multiple patient and single patient components as described in Patent Documents 1 and 2, respectively, the disclosures of which are incorporated herein by reference. Another example of such a system is the Bayer AVANTA® Fluid Injection System.

[0005] Since various multi-patient elements are used over several fluid injection procedures, a series of steps need to be implemented, or element design needs to be incorporated into the mechanism, to ensure that these elements are not exposed or that microbial contaminants that may be harmful to subsequent patients are removed by sterilization prior to the next injection procedure. For example, many systems may include swappable valves that can be disinfected by a skilled person wiping the valve with an alcohol-soaked wipe between injection procedures.

[0006] Conventional systems with swappable valves include a standard luer-type connector between multi-patient components and single-patient components that is adapted to a pre-made swappable valve on a female luer component and may include a threaded connection mechanism. Examples of threaded connectors for use in a multi-patient configuration are described in Patent Document 3, the disclosure of which is incorporated herein by reference. When performing multiple fluid injection procedures in a high-throughput situation, connecting, disconnecting, and manually wiping the swappable valve of a threaded connector can be time-consuming and may reduce the efficiency of the injection set. Furthermore, such threaded connections are susceptible to the effects of over-tightening or under-tightening, which can result in potential leaks or connection defects.

Prior Art Documents

Patent Documents

[0007]

Patent Document 1

Patent Document 2

Patent Document 3

Summary of the Invention

Problems to be Solved by the Invention

[0008] Positive disinfection when replacing a single patient fluid path element that has been used during an infusion procedure may be further desirable to reliably prevent contamination of the surfaces of multiple patient fluid path elements. There is a need for a novel system for positively disinfecting multiple patient fluid path components in an efficient and effective manner, including simple connection methods.

Means for Solving the Problems

[0009] The present disclosure provides a disinfected fluid component cap for use in ensuring a sterile connection between two fluid path components of a powered fluid infusion in a contrast imaging procedure, such as a computed tomography (CT), angiography (CV), and magnetic resonance imaging (MRI) imaging procedure.

[0010] In some embodiments, a disinfection cap for a fluid path element is provided. The disinfection cap may include a housing configured to fit at least partially over the fluid path element. The housing may include an open proximal end, a closed distal end, and a sidewall extending between the open proximal end and the closed distal end and defining an internal volume. The disinfection cap may further include a compressible absorbent material that is at least partially saturated with a disinfection fluid and disposed within the internal volume of the housing. The disinfection cap may further include an insert disposed within the internal volume and connected to the compressible absorbent material, the insert being movable toward the closed distal end to compress the compressible absorbent material as the insert moves toward the closed distal end of the fluid path element. The insert may include a fluid path sealing portion configured to seal a lumen on the fluid path element and a circumferential flange extending around the fluid path sealing portion, the circumferential flange comprising one or more passages configured to allow flow of the disinfection fluid from the compressible absorbent material to the fluid path element when the insert is biased toward the closed distal end by the fluid path element.

[0011] In some embodiments, the inner surface of the sidewall may comprise one or more radially inwardly projecting protrusions configured to removably engage the fluid path element and hold the disinfection cap on the fluid path element. Movement of the insert toward the closed distal end via movement of the fluid path element may compress the compressible absorbent material and release at least a portion of the disinfection fluid through one or more passages such that the disinfection fluid contacts at least a portion of the fluid path element.

[0012] In some embodiments, the circumferential flange may be attached to the inner surface of the sidewall of the housing. The fluid path sealing portion may include a rubber material, a flexible plastic material, or a silicone material configured to create a fluid-tight seal with the lumen of the fluid path element. The absorbent material may be a sponge or cotton. The disinfection fluid may include isopropyl alcohol, ethanol, a combination thereof, or an aqueous solution thereof.

[0013] In some embodiments, the gripping flange may project distally from the closed distal end. The sealing portion may be removably connected to the open proximal end, and the sealing portion fluidly seals the open proximal end. The sealing portion may include a pull tab that projects radially outward relative to the sidewall of the housing. The pull tab may be configured to remove the sealing portion from the open proximal end.

[0014] In some embodiments, a second compressible absorbent material may be provided on the proximal surface of the insert and may surround the fluid path sealing portion. The insert may be threadedly connected to the housing such that rotation of the insert relative to the housing moves the insert toward the closed distal end, compressing the compressible absorbent material and releasing at least a portion of the disinfection fluid.

[0015] In some embodiments, the fluid path sealing portion may include a key configured to engage a fluid path element to rotate the insert relative to the housing as the disinfection cap rotates. The inner surface of the closed distal end may include one or more ribs configured to prevent rotation of the compressible absorbent material relative to the housing. The proximal end of the compressible absorbent material may include a groove configured to receive at least a portion of the sidewall of the fluid path element.

[0016] In some embodiments, a disinfection cap for a fluid path element may include a housing configured to fit over at least a portion of the fluid path element, the housing having an open proximal end, an open distal end, and a sidewall extending between the open proximal end and the open distal end. The disinfection cap may further include a flange extending across the interior of the housing between the open proximal end and the open distal end, the flange having one or more openings. The disinfection cap may further include a compressible absorbent material at least partially saturated with a disinfection fluid, the compressible absorbent material being at the distal end of the flange. The disinfection cap may further include a plunger connected to the housing so as to surround the open distal end, the plunger being slidably movable relative to the housing between the open distal end and the open proximal end. Movement of the plunger in the proximal direction may compress the compressible absorbent material and discharge at least a portion of the disinfection fluid through the one or more openings.

[0017] In some embodiments, the flange may include a sealing surface configured to seal a lumen on the fluid path element. A second compressible absorbent material may be provided at the proximal end of the flange and may surround the sealing surface.

[0018] In some embodiments, the plunger may include a collapsible fluid bulb containing a disinfection fluid, the collapsible fluid bulb being collapsible by a pressing operation in the proximal direction to distribute the disinfection fluid into the housing through one or more holes at the proximal end of the plunger. The inner surface of the sidewall may include one or more radially inwardly projecting protrusions, the protrusions being configured to removably engage the fluid path element and hold the disinfection cap on the fluid path element.

[0019] In some embodiments, a disinfection cap for a fluid path element having an inner lumen and an outer cylindrical wall surrounding the inner lumen may include a housing configured to receive the inner lumen and the outer cylindrical wall of the fluid path element. The housing may include an open proximal end, a closed distal end, and a side wall extending between the open proximal end and the closed distal end and defining an internal volume. The disinfection cap may further include a sleeve protruding proximally from the inner surface of the closed distal end, the sleeve defining an opening configured to receive the inner lumen of the fluid path element. The disinfection cap may further include a compressible absorbent material at least partially saturated with a disinfection fluid, the compressible absorbent material being disposed within the internal volume of the housing and surrounding at least a portion of the outer portion of the sleeve. The outer cylindrical wall of the fluid path element may be configured to be received within a disinfection space between the inner surface of the housing and the sleeve such that movement of the fluid path element toward the closed distal end compresses the compressible absorbent material and releases at least a portion of the disinfection fluid into the disinfection space.

[0020] In some embodiments, the inner surface of the sleeve may be configured to sealingly engage the inner lumen of the fluid path element. The compressible absorbent material may extend substantially from the closed distal end to the proximal end of the housing.

[0021] In some embodiments, the sleeve may include one or more longitudinal ribs, the longitudinal ribs protruding radially outward and engaging the compressible absorbent material surrounding the outer portion of the sleeve to prevent rotation of the compressible absorbent material relative to the sleeve. The compressible absorbent material may have an axial slot configured to receive the outer cylindrical wall of the fluid path element. The sleeve may include a tab configured to provide tactile or audible feedback when the inner lumen of the fluid path element is fully inserted within the sleeve.

[0022] In some embodiments, there is provided a fluid path assembly that may include a fluid path element having an inner lumen and an outer cylindrical wall surrounding the inner lumen, and a disinfection cap configured to connect to the fluid path element. The disinfection cap may include a housing configured to receive the inner lumen and the outer cylindrical wall of the fluid path element, the housing including an open proximal end, a closed distal end, and a side wall extending between the open proximal end and the closed distal end and defining an internal volume. The disinfection cap may further include a sleeve protruding proximally from the inner surface of the closed distal end, the sleeve defining an opening configured to receive the inner lumen of the fluid path element. The disinfection cap may further include a compressible absorbent material at least partially saturated with a disinfection fluid, the compressible absorbent material being disposed within the internal volume of the housing and surrounding at least a portion of the outer portion of the sleeve. The outer cylindrical wall of the fluid path element may be configured to be received within a disinfection space between the inner surface of the housing and the sleeve such that movement of the fluid path element toward the closed distal end compresses the compressible absorbent material and releases at least a portion of the disinfection fluid into the disinfection space.

[0023] In some embodiments, the fluid path element may be a luer connector, a plurality of patient fluid path elements, or a single patient fluid path element. In some embodiments, the fluid path element may include a first connector element having a body, a first lumen, a first flexible leg, and a second flexible leg. The fluid path element may further include a second connector element having a body defining an undercut, a second lumen, a channel defined within the body, and at least one sealing element disposed within the channel. The first flexible leg may include a first flange, and the second flexible leg may comprise a second flange. When the first connector element engages the second connector element, the first flange and the second flange may engage the undercut of the body of the second connector element to prevent disengagement of the first connector element and the second connector element. When the first connector element and the second connector element engage each other, the sealing element may be configured to define a fluid-tight seal between the second lumen of the second connector element and the first lumen of the first connector element to form a fluid path.

[0024] In addition to the exemplary aspects and features described above, further aspects and features will become apparent by reference to the drawings and the following detailed description.

[0025] The features of the various embodiments of the disinfection cap described herein are specifically set forth in the appended claims. However, such features can be preferably understood by reference to the following description in conjunction with the accompanying drawings, both as to construction and method of operation.

Brief Description of the Drawings

[0026]

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DETAILED DESCRIPTION OF THE INVENTION

[0027] In FIGS. 1 to 34B, like characters refer to the same components and elements, where appropriate, unless otherwise specified.

[0028] The following description is provided to enable one of ordinary skill in the art to make and use the described embodiments contemplated for carrying out the present disclosure. However, various modifications, equivalents, variations, and alternative forms will be readily apparent to one of ordinary skill in the art. Any and all such modifications, variations, equivalents, and alternative forms are intended to fall within the spirit and scope of the present disclosure.

[0029] As used herein, the singular forms "a", "an", and "the" include plural referents unless otherwise specified. With respect to the use of any plural and / or singular terms herein, one of ordinary skill in the art can convert from plural to singular and / or from singular to plural, depending on the context and / or use. Various singular / plural substitutions are not explicitly set forth herein for clarity.

[0030] Spatial or directional terms such as "left", "right", "inner", "outer", "above", and "below" are related to the embodiments or aspects as shown in the drawings and should not be considered limiting since the embodiments or aspects can take various alternative orientations.

[0031] All numbers used in this specification and the claims should be understood to be modified in all cases by the term "about". "About" means ±25% of the recited value, for example, ±10% of the recited value. However, this should not be considered as limiting the analysis of values under the doctrine of equivalents.

[0032] Unless otherwise indicated, all ranges or ratios disclosed in this specification should be understood to include the starting and ending values, as well as every sub-range or sub-ratio subsumed therein. For example, a range or ratio described as "from 1 to 10" should be considered to include every sub-range or sub-ratio between and including the minimum value 1 and the maximum value 10, that is, every sub-range or sub-ratio that starts at a value greater than or equal to the minimum value 1 and ends at a value less than or equal to the maximum value 10. The ranges and / or ratios disclosed in this specification represent the average value over the specified range and / or ratio.

[0033] The term "includes" is synonymous with "comprises". Terms such as "first", "second", etc. are not intended to refer to a particular order or time series and refer to different conditions, characteristics, or elements.

[0034] All documents referred to in this specification are hereby incorporated by reference in their entirety.

[0035] The term "at least" is synonymous with "greater than or equal to". The term "not greater than" is synonymous with "less than or equal to". Some non-limiting embodiments or aspects may be described herein in relation to a threshold value. As used herein, meeting a threshold value may refer to a value that is greater than, higher than, greater than or equal to, less than, lower than, less than or equal to, equal to, etc. the threshold value.

[0036] In some examples, one or more components may be referred to herein as "configured", "operable", "adapted", etc. It should be understood by those skilled in the art that "configured", generally speaking, may include components in an operating state and / or non-operating state, and / or standby state, unless otherwise required by the context.

[0037] Some aspects may be described using the expressions "coupled" and "connected" along with their derivatives. It should be understood that these terms are not intended to be synonyms of each other. For example, some aspects may be described using the term "connected" to indicate that two or more elements are in direct physical or electrical contact with each other. In another example, some aspects may be described using the term "coupled" to indicate that two or more elements are in direct physical or electrical contact with each other. However, the term "coupled" may also mean that two or more elements are not in direct contact with each other but still cooperate or interact with each other.

[0038] The subject matter described in this specification may refer to various components that are included within or connected to other various components. It should be understood that the architectures shown in this way are merely illustrative, and in fact, many other architectures that achieve the same function may be implemented. In a conceptual sense, any configuration of components for achieving the same function is effectively "associated" so that the desired function is achieved. Therefore, any two components of this specification combined to achieve a particular function can be considered to be "associated" with each other so that the desired function is achieved, regardless of the architecture or intermediate components. Any two components so associated can also be considered to be "operably connected" or "operably coupled" to each other to achieve the desired function, and any two components that can be so associated can also be considered to be "operably coupled" to each other to achieve the desired function. Specific examples of operable coupling include, but are not limited to, components that are physically mating and / or physically interacting.

[0039] Furthermore, even if the description of a specific number of introduced claims is explicitly stated, one of ordinary skill in the art will recognize that such description should typically be construed to mean at least the number stated (e.g., a bare recitation of "two listings" without other modifiers typically means at least two listings, or two or more listings). Further, when using conventions similar to "at least one of A, B, and C," generally, such a construction is intended in a sense that one of ordinary skill in the art will understand the convention (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, a system having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together). When using conventions similar to "at least one of A, B, or C," generally, such a construction is intended in a sense that one of ordinary skill in the art will understand the convention (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, a system having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together). Disjunctive words and / or phrases presenting two or more alternative terms will typically be understood by one of ordinary skill in the art to contemplate the possibility of including one of the terms, any of the terms, or both terms, regardless of whether in the specification, claims, or drawings, unless the context indicates otherwise. For example, the phrase "A or B" is understood to include the possibilities of "A" or "B" or "A and B."

[0040] When used in reference to a component of a fluid delivery system, such as a fluid reservoir, syringe, connector, dust cap, or fluid line, the term "distal" refers to the portion of that component that is closest to the patient. When used in reference to a component of an injector system, such as a fluid reservoir, syringe, connector, disinfection cap, or fluid line, the term "proximal" refers to the portion of that component that is closest to the injector of the injector system (i.e., the portion of that component that is farthest from the patient). When used in reference to a component of a fluid delivery system, such as a fluid reservoir, syringe, connector, disinfection cap, or fluid line, the term "upstream" refers to the direction away from the patient and toward the injector with respect to the normal flow of fluid in the injector system. When used in reference to a component of a fluid delivery system, such as a fluid reservoir, syringe, connector, disinfection cap, or fluid line, the term "downstream" refers to the direction toward the patient and away from the injector with respect to the normal flow of fluid in the fluid delivery system.

[0041] The terms "radial" and related terms generally refer to a direction perpendicular to the longitudinal axis of a syringe, connector, dust cap, or other component of an injector system. However, it should be understood that the present disclosure may contemplate various alternative variations and step sequences, except where explicitly specified to the contrary. It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary aspects of the present disclosure. Accordingly, the specific dimensions and other physical characteristics related to the aspects disclosed herein should not be considered limiting.

[0042] Any reference to "an embodiment", "one aspect", or "an aspect" should be noted to mean that the particular features, structures, or characteristics described in connection with that embodiment or aspect are included in at least one embodiment or aspect. Thus, the appearances of the phrases "in one embodiment", "in one aspect", or "in an aspect" in various places throughout this specification are not necessarily all referring to the same embodiment and aspect. Further, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments or aspects.

[0043] One of ordinary skill in the art will recognize that the components (e.g., operations), devices, objects, and accompanying descriptions set forth herein are used as examples for clarity of concepts, and that various configuration changes are contemplated. Thus, as used herein, the particular examples described and the accompanying descriptions are intended to represent their general classes. In general, the use of any particular exemplification is intended to represent that class and should not be construed as limiting to the exclusion of particular components (e.g., operations), devices, and objects.

[0044] Before detailing the various aspects and features of the disinfection cap, it should be noted that the various aspects disclosed herein are not limited to the details of the structure and arrangement of the components shown in the accompanying drawings and description in their application or use. Rather, the disclosed devices may be arranged or incorporated into other devices, their variants, and modified forms, and may be implemented or executed in various ways. Thus, the aspects of the disinfection cap and features disclosed herein are exemplary in nature and do not mean to limit their scope or application. Further, unless otherwise indicated, the terms and expressions used herein are selected for the purpose of explaining the various aspects of the syringe and syringe mechanism for the convenience of the reader and do not limit its scope. Further, it should be understood that any one or more of the components and mechanisms of the disinfection cap, its expressions, and / or its examples, without limitation, may be combined with any one or more of other components, their expressions, and / or their examples.

[0045] The present disclosure relates to the design of a disinfection cap for use with fluid path elements associated with a powered fluid injector used in medical imaging procedures. According to various embodiments, certain medical imaging procedures may include the injection of a contrast agent or drug that emphasizes certain features within a medical image. A process known as contrast medical imaging generally includes the injection of a contrast agent with a suitable flushing agent, such as saline, prior to the imaging process. A powered fluid injector is used to control the injection of fluid and typically is designed using one or more, generally two, syringes for holding and dispensing a contrast agent, a flushing fluid, and other medical fluids administered before or during an imaging procedure. For example, U.S. Patent No. 5,383,858, which is incorporated herein by reference, discloses front-loading syringes and powered injectors in examples with and without a pressure jacket. Common contrast medical imaging procedures include computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET, SPECT), and conventional angiography (CV). Due to viscosity, it may be necessary to deliver the volume of contrast agent in a short period of time to provide a "tight bolus", so specific injection procedures may be performed at high injection pressures, such as up to 300 psi for CT and MR and up to 1200 psi for CV procedures. The injector may be configured to inject or dispense a fluid medium contained in a first, second, and / or additional syringe in a controlled manner such that it can be utilized in medical procedures such as angiography, CT, PET, and NMR / MRI. For example, U.S. Patent No. 5,383,858 and PCT International Publication No. WO 2022 / 035791, which are incorporated herein by reference, disclose front-loading syringes and powered injectors in examples with and without a pressure jacket.

[0046] A fluid injection system may include a configuration for multiple patient injections (multiple patient elements) in which some disposable elements of the fluid path set, such as a pumping mechanism (such as a syringe, components of a peristaltic pump system), and upstream components of the fluid path set, are used over a series of injection procedures prior to disposal, and another part of the disposable elements of the fluid path set (single patient elements) that are used once for a single patient and then discarded. Suitable examples of multiple patient elements and single patient elements are described, for example, in U.S. Patent Nos. 10,507,319 and 10,549,084, and International PCT Publication Pamphlets WO 2021 / 173743, WO 2022 / 119837, and WO 2022 / 182935, the disclosures of which are incorporated herein by reference. When the fluid injection procedure is completed, the single patient elements are disconnected from the multiple patient elements of the fluid path and discarded, and a new sterile single patient element is attached for the next injection procedure. Such a configuration can reduce the cost per fluid injection procedure and the amount of medical waste generated by the injection kit. Care must be taken to ensure that one or more distal connections of the multiple patient elements are not contaminated with microbial contaminants between injection procedures and are sterile when attaching a new single patient element. The sterility of the single patient elements is ensured by storage and removal from the associated sterile packaging immediately prior to connection to the multiple patient elements. The present disclosure provides components that can be used with the multiple patient elements to ensure that the connection mechanism of the multiple patient elements is sterile when connected to the single patient elements in preparation for subsequent injection procedures.

[0047] Referring to FIG. 1A, an exemplary fluid path set 100 according to some embodiments is shown. The fluid path set 100 may include at least one fluid reservoir 102, which may be a syringe or a peristaltic pump mechanism (not shown) connectable to a fluid injector to deliver fluid from the fluid reservoir 102 to a plurality of patient fluid path sets 104 and / or to fill the fluid reservoir 102 with fluid from a bulk fluid source. The plurality of patient fluid path sets 104 includes a fluid path element 106 for connecting to the fluid reservoir 102 at one end and a single patient fluid path set 108 at the opposite end. The single patient fluid path set 108 is configured to be disconnected from the plurality of patient fluid path sets 104 and discarded after each use, and a new sterile single patient fluid path set 108 is configured to be attached to the fluid path element of the plurality of patient fluid path sets 104 for the next injection procedure. After a predetermined time and / or a predetermined number of fluid delivery procedures, the plurality of patient fluid path sets 104 is configured to be discarded.

[0048] Referring to FIG. 1B, the fluid path element 106 (shown in FIG. 1B) of the plurality of patient fluid path sets 104 may include a body 110 having a lumen 112 extending therethrough configured to connect to a corresponding connector on the fluid reservoir 102 and / or the single patient fluid path set 108. The body 110 has a proximal end 111 configured to connect to a tube and a distal end 113 configured to connect to a corresponding connector on the fluid reservoir 102 and / or the single patient fluid path set 108, which can be protected and sterilized by a sterilization cap 200 as described herein. In an example of the present disclosure, the body 110 is configured to be substantially cylindrical in shape. The body 110 may define at least one opening 114 extending through an outer skirt 116 surrounding the outer surface of the lumen 112. The outer skirt 116 may help maintain the sterility of the fluid path, for example, by preventing inadvertent contact and contamination of the inner lumen 112 by a technician during operation of the fluid path element 106. In a particular embodiment of the present disclosure, the body 110 may not have an opening defined in the outer skirt 116. Further details of the structure of the fluid path element 106 are described in International PCT Application Publication No. WO 2021 / 168076, which is hereby incorporated by reference in its entirety.

[0049] Although not intended to be limited by any particular theory, if microbial contamination occurs, it is thought to be primarily on the "accessible" surfaces outside the fluid path element 106 assembly and on the outer surface of the lumen 112, and not on the inner surface of the lumen 112. Due to the shrouding effect of the outer skirt 116 that surrounds the lumen 112 and extends beyond the end face of the lumen 112, contact contamination on the surface of the inner face of the lumen 112 is unlikely to occur. However, environmental contamination may occur over long exposure times, for example, by interaction with airborne contaminants or movement of microorganisms. The outer surfaces external to the fluid path defined by the lumen 112 are unlikely to facilitate the movement of microbial contaminants into the lumen 112 during connection or disconnection. By use of the disinfection cap 200 described herein, disinfection of these surfaces, for example, the outer surface of the lumen 112 and the inner surface of the wall of the fluid path element 106, can prevent the movement of microbial contamination into the inner lumen 112 and its fluid contact surfaces.

[0050] The present disclosure provides an embodiment of a disinfection cap 200 configured to be removably attached to a fluid path element 106 of a multi-patient fluid path set 104 during transportation and / or after removal of a single-patient fluid path set 108. The disinfection cap 200 may perform several functions including, but not limited to: i) covering the fluid path element 106 of the multi-patient fluid path set 104 to prevent inadvertent contamination, for example, by contact of the fluid path element 106 of the multi-patient fluid path set 104 with a contaminated surface (e.g., surfaces of an infusion set or accidental contact with a healthcare provider's hand); and disinfecting a portion of the fluid path element 106 of the multi-patient fluid path set 104 by contact with a disinfecting, bactericidal and / or sterilizing fluid (e.g., isopropyl alcohol solution, ethanol solution, mixtures thereof, and aqueous solutions) stored within or added to the disinfection cap 200 prior to removal of the disinfection cap 200 and connection to the single-patient fluid path set 108. Ethanol solution may be used as it is an effective antibacterial agent, is compatible within the human bloodstream, and has been shown to reduce the need to seal the inner lumen of the fluid path from contact with the disinfecting fluid. Isopropyl alcohol is known to be bactericidal, tuberculocidal, fungicidal and virucidal. In certain embodiments, one or more sensors may be incorporated into the fluid injector to monitor the contact time between the fluid path element and the disinfection cap 200 to ensure complete disinfection is achieved.

[0051] The disinfection cap 200 may be configured for a standard connection mechanism such as a luer type connector, or may be designed to interact with a non-standard connection mechanism such as, but not limited to, a connector described in International PCT Application Publication No. WO 2021 / 168076, International Publication No. WO 2016 / 112163, International Publication No. WO 2015 / 106107, and International Publication No. WO 2006 / 060688, the disclosures of which are incorporated herein by reference, or a non-standard syringe nozzle such as that described in International Publication No. WO 2019 / 055497.

[0052] According to various embodiments, the disinfection cap 200 of the present disclosure may include an absorbent material, such as a polymer sponge, a cotton material, etc., in an inner portion of the disinfection cap 200, and the absorbent material is at least partially saturated with a disinfection fluid. When the disinfection cap 200 is engaged with the fluid path element 106 of the plurality of patient fluid path sets 104 and the working surface is pressed by a user, the disinfection cap and the absorbent material are pressed against the plurality of patient fluid path elements 106, compressing the absorbent material and bringing the disinfection fluid into contact with at least a portion of one or more surfaces of the plurality of patient fluid path elements 106, thereby disinfecting the one or more surfaces. In certain embodiments, at least a portion of the sponge may include an open-cell matrix for releasably capturing the disinfection fluid. In various embodiments, at least a portion of the sponge may include a closed-cell matrix that is non-absorbent to the disinfection fluid. For example, the closed-cell portion may be incorporated into a portion of the sponge that contacts the rim of the lumen 112 to prevent the release of the disinfection fluid into the interior of the lumen 112, while a portion of the sponge that does not contact the area abutting the lumen may include an open-cell matrix for releasing the disinfection fluid to the outer surface of the lumen upon compression.

[0053] In certain embodiments, the disinfection cap 200 may include a fluid path sealing portion or protrusion that sealingly engages with the lumen 112 of the plurality of patient fluid path sets 106 to prevent the inflow of the disinfection fluid into the lumen 112 and / or to prevent any fluid from dripping out of the interior of the lumen 112. By preventing the inflow of the disinfection fluid into the lumen 112, for example, when the disinfection fluid flows through the passage and contacts at least a portion of one or more surfaces of the plurality of patient fluid path sets 104, contamination of the lumen and any medical fluid therein is avoided by preventing the flushing of any microbial contaminants into the lumen 112. For example, the sealing portion or protrusion may include a sealable material (such as silicone, a polymer material, a closed-cell foam, etc.) that engages and seals with the rim of the lumen to prevent the entry of the disinfection fluid into the lumen 112.

[0054] Referring to FIGS. 2A-2C, a disinfection cap 200 according to an embodiment of the present disclosure is shown. The disinfection cap 200 may include a housing 202 configured to fit at least a portion of the fluid path element 106 (shown in FIG. 1B). In some embodiments, the housing 202 may be made of a medical grade plastic material. The housing 202 may include an open proximal end 204, a closed distal end 206, and a side wall 208 extending between the open proximal end 204 and the closed distal end 206 to form an internal volume 210 (shown in FIGS. 2B-2C). In some embodiments, the housing 202 may have a shape corresponding to at least a portion of the shape of the fluid path element 106. For example, the housing 202 may be configured and designed to fit at least a portion of the fluid path element 106, such as the lumen 112 and the outer skirt 116. The exterior of the closed distal end 206 may include a gripping element 212, such as a tab for the user to handle, to enable easy attachment and removal of the disinfection cap 200 to the fluid path element 106. The gripping element 212 may project distally from the closed distal end 206. In some embodiments, the gripping element 212 may be formed on the outer surface of the housing 202, such as the side wall 208. For example, the gripping element 212 may be one or more protrusions projecting radially outward from the outer surface of the housing 202.

[0055] Referring to FIGS. 2B-2C, a compressible absorbent material 214 may be disposed within the internal volume 210 of the housing 202. In some embodiments, the compressible absorbent material 214 may be in contact with or connected to the closed distal end 206. The compressible absorbent material 214 may be at least partially saturated with a disinfection fluid as described herein. In some embodiments, the compressible absorbent material 214 may have an annular shape with a central opening 216. In other embodiments, the compressible absorbent material 214 may be made in a cylindrical shape to fill at least a portion of the internal volume 210. The compressible absorbent material 214 may be made of a sponge material (continuous and / or independent cells), a cotton material, or other medical grade absorbent materials.

[0056] Other embodiments of the disinfection cap 200 may be provided in a dried and sterilized form, and disinfection fluid may be added to the disinfection cap 200, for example, immediately before or when the disinfection cap 200 is attached to the fluid path element 106 from a bulk disinfection fluid source. In this way, the problems associated with sealing the disinfection cap 200 with fluid and the possibility of the fluid drying can be avoided.

[0057] Referring to FIGS. 2D-2E, when the disinfection cap 200 is engaged with the fluid path element 106 of the multi-patient fluid path set 104 in a first position (FIG. 2D) and the fluid path element 106 is biased toward the closed distal end 206, the disinfection cap 200 and the compressible absorbent material 214 are pressed against the multi-patient fluid path elements 106 in a second position (FIG. 2E), thereby compressing the compressible absorbent material 214 and bringing the disinfection fluid into contact with at least a portion of one or more surfaces of the multi-patient fluid path elements 106, thereby disinfecting the one or more surfaces. FIGS. 2D and 2E show different disinfection caps 200, but the engagement mechanism is the same for both disinfection caps 200.

[0058] Referring to FIGS. 2B-2C, the disinfection cap 200 may include a slidable insert 218 that is proximally adjacent to the compressible absorbent material 214 within the internal volume 210. For example, the slidable insert 218 may abut the proximal surface 220 of the compressible absorbent material 214. The slidable insert 218 may include a fluid path sealing surface 222 configured to engage the distal surface 118 (shown in FIG. 1B) of the lumen 112 of the fluid path element 106. As shown in FIGS. 2D-2E, the fluid path sealing surface 222 is configured to seal the lumen 112 of the fluid path element 106, thereby preventing fluid communication and the entry of disinfection fluid into the lumen 112 and preventing the medical fluid within the lumen 112 from flowing into the internal volume 210 of the disinfection cap 200. In certain embodiments, the fluid path sealing surface 222 may include a rubber, flexible plastic, closed-cell sponge, or silicone material configured to create a fluid-tight seal with the lumen 112 of the fluid path element 106.

[0059] Referring to FIG. 2C, the slidable insert 218 can further include a circumferential flange 224 that extends radially around the fluid path sealing surface 222. The circumferential flange 224 may include one or more passages 226, such as slots or holes, that extend through the slidable insert 218 and are in fluid communication there through. In some embodiments, the passages are configured to be held in a normally closed position (not in fluid communication there through) and then deform and open under fluid pressure, such as when the fluid path element 106 is biased toward the closed distal end 206, allowing fluid communication between the disinfection fluid in the compressible absorbent material 214 and the fluid path element 106. The one or more passages 226 may be made of or coated with a flexible material. Alternatively, the passages 226 may include a cover material, for example, by flushing over the holes or by attaching an adhesive film that at least partially releases or breaks when sufficient pressure is applied by the disinfection fluid.

[0060] For example, by pressing the disinfection cap 200 onto the fluid path element 106 or by moving the disinfection cap 200 from an inactive first position where the disinfection cap 200 merely covers the distal end of the fluid path element 106 to an active second position where the disinfection cap 200 is further pressed against the distal end of the fluid path element 106, when the slidable insert 218 engages the distal end of the fluid path element 106, the circumferential flange 224 is pressed against the compressible absorbent material 214, thereby compressing the compressible absorbent material 214 (see FIG. 2E), which releases the disinfection fluid from the compressible absorbent material 214 through one or more passages 226 into contact with the surface of the fluid path element 106, enabling disinfection of the contacted surface.

[0061] At least partial compression of the compressible absorbent material 214 is configured to release the disinfection fluid from the compressible absorbent material 214, and the disinfection fluid flows through one or more passages 226 of the circumferential flange 224 and contacts one or more surfaces of the fluid path element 106, such as the outer surface of the lumen 112 and the inner and outer surfaces of the outer skirt 116. Contact between the disinfection fluid and the various surfaces of the fluid path element 106 and the sealing elements (e.g., O-rings, etc.) for an appropriate time, e.g., from a few seconds to a maximum of 7 days, effectively disinfects the contact surfaces of any microbial contaminants, such as pathogenic bacteria, viruses, particles of former patient body fluids, and other disease-causing pathogens. In certain embodiments, the disinfection cap 200 and the corresponding compressible absorbent material 214 may rotate about the longitudinal axis of the fluid path element 106, providing a polishing action to further assist in disinfecting the contacted surfaces. When the disinfection cap 200 has completed the disinfected engagement with the fluid path element 106 for a predetermined time and the technician is ready to initiate the next injection procedure, the disinfection cap 200 may be removed, for example, by gripping the gripping element 212 and pulling the disinfection cap 200 away from the fluid path element 106, and a new single-patient fluid path set 108 (shown in FIG. 1A) may be connected to the disinfected distal end of the multi-patient fluid path element 106.

[0062] According to one alternative embodiment, the disinfection fluid may be housed within the disinfection cap 200 without the compressible absorbent material 214, whereby the disinfection fluid is sealably retained by the circumferential flange 224 of the slidable insert. In such an embodiment, the circumferential flange 224 may be sealably connected to the inner surface 228 of the side wall 208. When the disinfection cap 200 is pressed against the distal end of the fluid path element 106, pressure is generated in the disinfection fluid up to the point where the pressure overcomes the seal between the circumferential flange 224 and the inner surface 228 of the side wall 208 of the disinfection cap 200. The disinfection fluid may then flow through the slidable insert 218 and contact the fluid path element 106 as described herein. Further, when the insert 218 is pressed against the distal face of the fluid path element 106, the fluid path sealing surface 222 creates a fluid-tight seal with the lumen 112 and prevents fluid communication between the internal volume 210 of the disinfection cap 200 and the lumen 112.

[0063] Referring to FIGS. 2B - 2C, the inner surface 228 of the disinfection cap 200 may include one or more radially inwardly projecting protrusions 230 or retaining bumps at the proximal end 204. The one or more radially inwardly projecting protrusions 230 may be configured to removably engage a corresponding engagement mechanism 120 such as a flange, top surface, at least partial lip, and / or at least partial circumferential groove around the proximal end 111 of the fluid path element 106 shown in FIGS. 2D - 2E, or one or more indentations on the surface of the outer skirt 116 of the fluid path element 106. Engagement of the one or more protrusions 230 with the corresponding engagement mechanism 120 on the fluid path element 106 releasably holds the disinfection cap 200 on the fluid path element 106 and may prevent inadvertent removal of the disinfection cap 200 due to impacts or gravity during storage or transportation, for example.

[0064] The interaction between one or more radially inwardly projecting protrusions 230 on the disinfection cap 200 and corresponding engagement mechanisms 230 on the fluid path element 106 may be configured to provide an auditory and / or visual indicator to indicate to a skilled person that the disinfection cap 200 is fixed to the fluid path element 106 and / or that the disinfection cap 200 has been moved to a second operating state and the fluid path element 106 has been contacted with the disinfection fluid. The mechanism for generating the auditory and / or visual indicator may be located on the disinfection cap 200, the fluid path element 106, or both, which are configured to interact when the disinfection cap 200 is attached and / or moved to the second operating state. The auditory and / or visual indicator may further include one or more colors, lines, permanent deformations, audible clicks, or snaps, etc., to indicate to a skilled person that the disinfection fluid has been dispensed and the fluid path element 106 has been disinfected.

[0065] Referring to FIG. 2A, the disinfection cap 200 may further include a sealing portion 232. In some embodiments, the sealing portion 232 may extend across the open proximal end 204 and surround the internal volume 210 (shown in FIG. 2B). The sealing portion 232 may be removably attached to and cover the open proximal end 204 of the disinfection cap 200 and may be an adhesive and / or frangible seal. The sealing portion 232 enables the transportation and storage of the disinfection cap 200 without loss (e.g., evaporation) and / or contamination of the disinfection fluid within the internal volume 210 of the housing 202. The sealing portion 232 may be a single sealing portion, i.e., a sealing portion that covers only a single disinfection cap 200, or a multi-cap sealing portion, e.g., an extended rectangular or square surface having a plurality of sealing sections for storing and sealing a plurality of disinfection caps 200, as described herein with reference to FIG. 34A. The plurality of disinfection caps 200 may be removed one by one from the multi-cap sealing portion 232, if necessary, without affecting the sterility or condition of the remaining disinfection caps 200.

[0066] The disinfection cap 200 may be connectable to the fluid path set 106 in a first non-operating state where the disinfection fluid is not in contact with the surface of the fluid path element 106, and in a second operating state where the disinfection fluid is in contact with the surface of the fluid path element 106. In some embodiments, the disinfection cap 200 may transition from the non-operating state to the operating state by axial movement along the longitudinal axis L (shown in FIGS. 2B and 2C) and / or by rotational movement about the longitudinal axis L, such as by movement of the disinfection cap 200 relative to the fluid path element 106.

[0067] In certain embodiments, the disinfection cap 200 is configured to twist about the longitudinal axis L after being pressed, engaging the disinfection cap 200 and the compressible absorbent material 214 with the fluid path element 106 to provide a polishing action between the compressible absorbent material 214 and various surfaces of the fluid path element 106, further contacting the disinfection fluid with the surface of the fluid path element 106, and increasing the disinfection effect. The twisting may be achieved by manually rotating the gripping element 212 during or after engaging the disinfection cap 200 with the fluid path element 106.

[0068] After activation, the disinfection cap 200 may remain engaged with the fluid path element 106 in the operating state for a time sufficient to disinfect all contact surfaces from any microorganisms or pathogenic substances. The disinfection cap 200 may also act as a dust cap and prevent contamination of the distal end 113 of the fluid path element 106 by dust particles that may float in the air within the injection set. The disinfection cap 200 may remain in place until the next patient and injector are prepared for the subsequent patient's injection procedure, at which point they may be removed, and the disinfected / sterilized distal ends of the plurality of patient fluid path elements 106 may be engaged with the proximal end of a single patient fluid path set 108 (shown in FIG. 1A).

[0069] Referring to FIGS. 3A - 34B, a disinfection cap 200 according to an additional embodiment of the present disclosure is shown. The components of the disinfection cap 200 shown in FIGS. 3A - 34B are substantially similar or identical to the components of the disinfection cap 200 described herein with reference to FIGS. 2A - 2F. Accordingly, the reference numerals in FIGS. 3A - 34B are used to indicate the same components as the corresponding reference numerals in FIGS. 2A - 2F. The foregoing description regarding the disinfection cap 200 generally shown in FIGS. 2A - 2F is applicable to the disinfection cap 200 shown in FIGS. 3A - 34B, so only the relative differences between the disinfection caps 200 will be described below.

[0070] Referring to FIGS. 3A - 3B, the disinfection cap 200 may include a double compressible absorbent material configuration having compressible absorbent materials 214 on both sides of the slidable insert 218. Specifically, a first compressible absorbent material 214a is provided on the distal side of the insert 218, and a second compressible absorbent material 214b is provided on the proximal side of the insert 218. The first compressible absorbent material 214a acts to release a disinfection fluid and contact various outer surfaces of the fluid path element 106, such as the surface of the outer skirt 116 of the fluid path element 106. The second compressible absorbent material 214b has a central opening 216 configured to receive the lumen 112 of the fluid path element 106, whereby the lumen 112 can contact the fluid path sealing surface 222 of the slidable insert 218 to seal the lumen 112 from the internal volume 210 of the disinfection cap 200. As shown in FIG. 3B, the second compressible absorbent material 214b is configured to be received inside the outer skirt 116 of the fluid path element 106. In this way, rotation of the disinfection cap 200 about the longitudinal axis L with respect to the fluid path element 106 will abrade the inner surface of the outer skirt 116 and the outer surface of the lumen 112 via the second compressible absorbent material 214b.

[0071] Referring to FIGS. 3C-3D, the insert 218 may have a threaded distal end portion 234 configured to threadedly engage the housing 202 of the disinfection cap 200. For example, the disinfection cap 200 may include an inner threaded portion configured to engage the threaded distal end portion 234 of the slidable insert 218 such that when the disinfection cap 200 rotates about the longitudinal axis L, the slidable insert 218 moves distally toward the closed distal end 206, compressing the compressible absorbent material 214 and releasing the disinfection fluid. The proximal end portion 236 of the insert 218 may have a key 238 configured to engage a fluid path element 106, such as the lumen 112. In this way, when the disinfection cap 200 is connected to the fluid path element 106, the corresponding mechanism at the end of the lumen 112 engages the key 238, whereby rotation of the disinfection cap 200 about the longitudinal axis L moves the slidable insert 218 distally via the threaded engagement between the threaded distal end portion 234 and the housing 202. Such distal movement compresses the compressible absorbent material 214 to release the disinfection fluid and disinfects the fluid path element 106.

[0072] In an alternative embodiment, the threaded portion may be on the slidable insert 218 and may be configured to interact with the associated protrusions on the inner surface portion of the disinfection cap 200 to thread the disinfection cap 200 onto the fluid path element 106. The rear portion of the slidable insert 218 may include one or more rotation keys configured to engage the corresponding mechanism at the end of the fluid path element 106, such as a fluid diverter element (see, e.g., International PCT Application No. PCT / US2021 / 018523 pamphlet), to hold the slidable insert 218 in a non-rotating position when the disinfection cap 200 rotates.

[0073] In another embodiment, the disinfection cap 200 may include a slidable insert 218 having a push-to-screw configuration. According to this embodiment, the act of pressing the disinfection cap 200 onto the fluid path element 106 in the direction of the longitudinal axis L engages the slidable insert 218 with the threaded portion of the disinfection cap 200 and self-screws / rotates the slidable insert 218 during the engagement process, thereby compressing the compressible absorbent material 214 and releasing the disinfection fluid from the compressible absorbent material 214 to disinfect the surface of the fluid path element 106.

[0074] Referring to FIGS. 4A-4C, the disinfection cap 200 may have a keyed anti-rotation compressible absorbent material 214. For example, the compressible absorbent material 214 saturated with the disinfectant may have one or more anti-rotation slots 242 (shown in FIG. 4C) configured to engage with one or more corresponding anti-rotation protrusions 244 (shown in FIG. 4A) on the inner surface 228 of the housing 202. The one or more anti-rotation slots 242 may be configured to receive the one or more anti-rotation protrusions 244 such that the compressible absorbent material 214 rotates with the rotation about the longitudinal axis L of the disinfection cap 200 (shown in FIG. 4A). In some embodiments, the positions of the one or more anti-rotation slots 242 and the one or more anti-rotation protrusions 244 may be reversed such that the one or more anti-rotation slots 242 are provided on the inner surface 228 of the housing 202 and the one or more anti-rotation protrusions 244 are provided on the compressible absorbent material 214.

[0075] The compressible absorbent material 214 is keyed to the sterilization cap 200 and rotates with the sterilization cap 200. Thus, when the sterilization cap 200 is pressed toward the fluid path element 106, the keying elements (i.e., one or more anti-rotation slots 242 and one or more anti-rotation protrusions 244) engage such that the compressible absorbent material 214 rotates with the sterilization cap 200. In this way, as the sterilization cap 200 rotates about the longitudinal axis L, the compressible absorbent material 214 abrades one or more surfaces of the fluid path element 106 while releasing the sterilizing fluid, thereby improving the sterilization effect. The keying configuration has been described as including one or more anti-rotation slots 242 and one or more anti-rotation protrusions 244, but other complementary keying mechanisms may be incorporated into the sterilization cap 200 and the compressible absorbent material 214 and still remain within the scope of the present embodiment.

[0076] Referring to FIG. 5A, various embodiments of the compressible absorbent material 214 may have circumferential grooves 246 that are recessed with respect to the proximal surface 248 (shown with reference to the embodiments of FIGS. 4A-4C, but not limited thereto). The circumferential grooves 246 may be configured to engage the distal rim of the outer skirt 116 of the fluid path element 106 (FIG. 5B) such that the compressible absorbent material 214 engages both the inner and outer surfaces of the outer skirt 116. In certain embodiments, the compressible absorbent material 214 may be keyed to engage the inner surface 228 of the housing 202 as described herein such that the compressible absorbent material 214 rotates with the sterilization cap 200 during the sterilization process, thereby abrading and sterilizing the engagement surface of the fluid path element 106. In this embodiment, both the inner and outer surfaces of the outer skirt 116 are in contact with the sterilizing fluid and are effectively sterilized during the abrasion process due to contact with the compressible absorbent material 214. Alternatively, in another embodiment, the compressible absorbent material 214 having the circumferential grooves 246 may be used as a stand-alone sterilization element without a keyed connection to the housing 202. According to this alternative embodiment, the user simply engages the compressible absorbent material 214 with the fluid path element 106 and rotates the absorbent element to abrade and sterilize the inner and outer surfaces of the outer skirt 116 of the fluid path element 106.

[0077] Referring to FIGS. 6A-6D, according to another embodiment of the present disclosure, the disinfection cap 200 may include a slidable plunger 250 (shown in FIG. 6A) movable relative to the housing 202 in the direction of the longitudinal axis L to compress the compressible absorbent material 214 and release the disinfection fluid therefrom. The disinfection cap 200 may include a housing 202 configured to fit at least partially over the fluid path element 106. The housing 202 has an open proximal end 204, an open distal end 252, and a sidewall 208 extending between the open proximal end 204 and the open distal end 252. The gripping element 212 is shown as a flange extending radially outward from at least a portion of the outer surface of the sidewall 208 of the housing 208 to enable the user to attach, actuate, and remove the disinfection cap 200 by gripping the gripping element 212. Other configurations of the gripping element 212 are also contemplated.

[0078] Continuing to refer to FIG. 6A, the inner flange 254 may extend radially inward from the inner surface 228 of the housing 202 into the internal volume 210. The inner flange 254 may include one or more fluid passages 255 extending therethrough to allow the disinfection fluid to flow from the distal side 260 of the inner flange 254 to the proximal side 262 of the inner flange 254. In some embodiments, the inner flange 254 may include a sealing surface 258 on the proximal side 262. In certain embodiments, the sealing surface 258 may be on a projection 256 extending in the proximal direction, located in the central portion of the inner flange 254 and surrounded by one or more fluid passages 255. The sealing surface 258 may be configured to seal the lumen 112 of the fluid path element 106 to prevent entry of any of the disinfection fluids into the internal volume of the lumen 112 when the disinfection cap 200 is connected to the fluid path element 106.

[0079] Continuing to refer to FIG. 6A, the disinfection cap 200 may have a compressible absorbent material 214 between the proximal side 262 of the inner flange 254 and the slidable plunger 250. When the slidable plunger 250 moves axially in a direction toward the proximal side 262 of the inner flange 254, the compressible absorbent material 214 is compressed, thereby releasing the disinfection fluid therefrom. The disinfection fluid can then flow through one or more fluid passages 255 so as to contact the fluid path element 106. As described herein with reference to FIGS. 2A-2F, one or more radially inwardly projecting protrusions 230 or retaining bumps may be provided on the inner surface 228 of the housing 202 at the open proximal end 204 to interact with corresponding mechanisms or grooves on the fluid path element 106.

[0080] According to another embodiment, the compressible absorbent material 214 may be disposed on each side of the inner flange 254. For example, the compressible absorbent material 214 may have a first compressible absorbent material 214a on the distal side 260 of the inner flange 254 and a second compressible absorbent material 214b on the proximal side 262 of the inner flange 254. This configuration of the first and second compressible absorbent materials 214a, 214b is similar to that described herein with reference to FIGS. 3A and 3B. As described herein with reference to FIGS. 5A-5C, the second compressible absorbent material 214b that abuts the fluid path element 106 may have a circumferential groove 246 for engaging both the internal mechanism and the outer surface of the outer skirt 116.

[0081] Referring to FIGS. 6C-6D, the slidable plunger 250 may include a pressing surface 264 configured to be actuated by a user pressing the disinfection cap 200 to enable the release of the disinfection fluid. For example, the user may grip the gripping element 212 of the housing 202 with the index finger and middle finger of the hand and press the pressing surface 264 of the slidable plunger 250, for example, with the thumb, to actuate the disinfection cap 200. In certain embodiments, the pressing surface 264 may include one or more longitudinal ribs to provide a uniform pressing surface. Other configurations of the pressing surface 264 include circular ribs or flat surfaces.

[0082] In some embodiments, the pressing surface 264 may be configured to allow rotation of the slidable plunger 250 about the longitudinal axis L (shown in FIG. 6B). According to this embodiment, the gripping mechanism on the pressing surface 264 may be in the form of one or more flat, radially extending wings that can be gripped by the other hand of the user to assist in the rotational actuation of the sterilization cap 200. In such an embodiment, the slidable plunger 250 may be threaded with the inner flange 254 such that the rotational movement of the slidable plunger 250 about the longitudinal axis L axially moves the slidable plunger 250 towards the inner flange 254. Thus, the actuation of the sterilization cap 200 includes rotating the slidable plunger 250 clockwise or counterclockwise to threadedly move the slidable plunger 250 proximally to an actuated state, thus forcing the sterilization fluid under pressure through one or more fluid passages 255.

[0083] When the slidable plunger 250 is connected to the open distal end 252 of the housing 202, the proximal end 266 of the slidable plunger 250 may be configured to define an internal volume 210 between the inner flange 254 and the proximal end 266 of the slidable plunger 250 (FIG. 6A). The internal volume 210 of the sterilization cap 200 may be configured to contain a sterilization fluid therein. In certain embodiments, the sterilization fluid may be at least partially absorbed by a compressible absorbent material 214 held in the internal volume 210 such that compression of the compressible absorbent material 214 during actuation of the sterilization cap 200 releases at least a portion of the sterilization fluid. Alternatively, the internal volume 210 may simply contain mainly the sterilization fluid therein such that movement of the slidable plunger 250 towards the proximal end 204 of the housing 202 forces the sterilization fluid through one or more passages 255 within the inner flange 254.

[0084] The slidable plunger 250 may be retained within the housing 202 by a taper fit, friction fit, or one or more protrusions 268 on the outer peripheral surface of the slidable plunger 250 or the inner surface 228 of the housing 202, whereby the slidable plunger 250 remains stationary unless a predetermined force is applied to the pressing surface 264 and overcomes the frictional force of the one or more protrusions 268. In certain embodiments, the sliding of the slidable plunger 250 can be prevented by one or more protrusions 268 or flexible tabs extending radially inward from the inner surface of the open distal end 252 of the housing 202, unless a minimal force is applied to the pressing surface 264. Then, actuation of the sterilization cap 200 requires applying sufficient force to the slidable plunger 250 to move the slidable plunger 250 past or beyond one or more protrusions 268 or flexible tabs. The slidable plunger 250 is slidable between a first non-operating state in which the slidable plunger 250 is positioned at the open distal end 252 of the housing 202 and defines an internal volume 210, and a second operating state in which the slidable plunger 250 moves axially in the proximal direction by applying pressure to the pressing surface 264. When the slidable plunger 250 is moved to the operating state, the proximal end 266 of the slidable plunger 250 compresses the compressible absorbent material 214 and / or the sterilization fluid within the internal volume 210, resulting in an increase in the pressure of the sterilization fluid within the internal volume 210. When the pressure of the sterilization fluid within the internal volume 210 reaches a threshold pressure, the sterilization fluid is forced to pass through one or more fluid passages 255 within the inner flange 254 and contact one or more surfaces of the fluid path element 106, thereby sterilizing those surfaces. Other embodiments may include a one-way valve extending through the inner flange 254, whereby the sterilization fluid flows through the one-way valve and contacts the fluid path element 106.

[0085] After activation, the disinfection cap 200 remains engaged with the fluid path element 106 in the activated state for a predetermined length of time sufficient to disinfect all outer surfaces from any microorganisms or pathogenic substances. The disinfection cap 200 may also act as a dust cap to prevent contamination of the distal end of the fluid path element 106 by dust particles that may float in the air within the injection set. The disinfection cap 200 may remain in place until the next patient and injector are prepared for the subsequent patient's injection procedure, at which point they may be removed, and the disinfected / sterilized distal ends of the plurality of patient fluid path elements 106 may be engaged with the proximal end of the single patient fluid path element 108.

[0086] Referring to FIGS. 7A-7B, the slidable plunger 250 and the inner flange 254 are screw-connected via a threaded configuration 270. In some embodiments, the threaded configuration 270 has corresponding threaded surfaces that, when rotated, axially slide the slidable plunger 250 between a non-activated state and an activated state. The slidable plunger 250 may include a fluid reservoir 272 for containing any volume of disinfection fluid. The distal wall 274 of the slidable plunger 250 is made of a flexible and deformable elastomeric material. In certain embodiments, the fluid reservoir 272 may also include a compressible absorbent material at least partially saturated with the disinfection fluid.

[0087] Continuing to refer to FIGS. 7A-7B, the proximal side 262 of the slidable plunger 250 has one or more pressure-actuated passages 276, such that when pressurized, the disinfection fluid can flow through the pressure-actuated passages 276. In this embodiment, the disinfection cap 200 need not contain a compressible absorbent material and / or disinfection fluid within the internal volume 210 defined between the slidable plunger 250 and the inner flange 254. Instead, when the slidable plunger 250 is rotatably moved from the non-operating state to the operating state, the user can apply pressure to the distal wall 274 of the slidable plunger 250 during rotation or after the slidable plunger 250 has rotatably contacted the inner flange 254. Thus, the disinfection fluid within the fluid reservoir 272 is pressurized and moves through the pressure-actuated passages 276 and one or more passages 255 within the inner flange 254 to contact and disinfect any outer surface of the fluid path element 106 (shown in FIG. 7B). In some embodiments, the pressure-actuated passages 276 may be in a normally closed position prior to actuating the slidable plunger 250 by pressing the distal wall 274 in the proximal direction. The disinfection cap 200 may include a fluid path sealing surface 222, as described herein, which creates a fluid-tight seal against the lumen 112 of the fluid path element 106 and prevents the entry of disinfection fluid or other contaminants into the lumen 112.

[0088] In certain embodiments, the fluid reservoir 272 may include a thin film over the pressure-actuated passages 276 to hold the disinfection fluid. When sufficient pressure is applied in the proximal direction to the distal wall 274, the disinfection fluid within the fluid reservoir 272 is pressurized to a sufficient pressure to break the thin film and allow the disinfection fluid to exit the fluid reservoir 272.

[0089] Referring to FIGS. 8A-8B, a housing 202 includes an open proximal end 204 configured to releasably engage the outer surface of the fluid path element 106, a closed distal end 206 surrounded by a flexible and deformable elastomeric membrane 278, and a side wall 208 extending between the open proximal end 204 and the closed distal end 206. The disinfection cap 200 has the housing 202. The disinfection cap 200 further includes an inner fluid reservoir 280 defined by a flexible and deformable elastomeric membrane 278, an inner surface 228 of the distal portion of the side wall 208, and an inner flange 254 extending radially inward from the side wall 208 to define the inner fluid reservoir 280. The inner fluid reservoir 280 may be filled with a disinfection fluid. In certain embodiments, the inner fluid reservoir 280 may also include a compressible absorbent material, such as the compressible absorbent material described herein with reference to FIGS. 2A-2F, that is at least partially saturated with the disinfection fluid. In certain embodiments, the compressible absorbent material, such as a sponge, may act as a spring to keep the flexible and deformable elastomeric membrane 278 in an inflated state when no pressure is applied and to release the disinfection fluid when pressure is applied by the user to the flexible and deformable elastomeric membrane 278. After the user releases the pressure on the elastomeric membrane 278, the compressible absorbent material may return to its original uncompressed state. When the compressible absorbent material returns to its uncompressed state, it can absorb excess disinfection fluid and return the elastomeric membrane 278 to its extended state, at which point the elastomeric material can be recompressed a second time.

[0090] The inner flange 254 may include a fluid path sealing surface 222 (shown in FIG. 8A) on its proximal side. The fluid path sealing surface 222 may be configured to seal the lumen 112 of the fluid path element 106 (shown in FIG. 8B) to prevent any of the disinfection fluid from entering the internal volume of the lumen 112 or to prevent fluid from dripping from the inside of the lumen 112 when the disinfection cap 200 is actuated. The inner flange 254 may further include one or more fluid passages 255 as described herein to allow fluid communication between the inner fluid reservoir 280 and the proximal internal volume 210 of the disinfection cap 200.

[0091] For example, after removing a used single patient fluid path element, when engaging with the fluid path element 106, the disinfection cap 200 may be actuated by applying pressure proximally to the flexible and deformable elastomeric membrane 278. For example, the user may apply pressure with a thumb or other finger by pressing on the elastomeric membrane 278. When the internal disinfection fluid reaches a predetermined pressure, one or more fluid passages 276 may open such that the disinfection fluid flows through the fluid passage 255 and contacts one or more surfaces of the fluid path element 106. After actuation, the disinfection cap 200 may remain engaged with the actuated fluid path element 106 for a sufficient time to disinfect the outer surface of the fluid path element 106 from any microorganisms or pathogenic substances.

[0092] Referring to FIGS. 9A-9B, the disinfection cap 200 may include a housing 202 having an open proximal end 204, a closed distal end 206, and a side wall 208 extending between the open proximal end 204 and the closed distal end 206. The disinfection cap 200 may further include a sealing member 282 attached to the inner surface 228 of the side wall 208. When the fluid path element 106 is connected to the disinfection cap 200 to prevent the ingress of contaminants or the outflow of fluid therefrom, the sealing member 282 may be configured to fluidly seal the inner volume of the lumen 112 of the fluid path element 106. A thin flexible material 284 extends radially outward from the sealing member 282 toward the inner surface 228 of the side wall 208. The non-flexed flexible material 284, together with the sealing member 282 and the closed distal end 206, defines the proximal end of the internal volume 210 of the disinfection cap 200.

[0093] The proximal end of the internal volume 210 may include a compressible absorbent material 214 that is at least partially saturated with a disinfecting fluid. The disinfecting cap may be moved from a first non-operating state to a second operating state by pressing on the distal end of the disinfecting cap 200 or otherwise moving the disinfecting cap 200 in the proximal direction. When the disinfecting cap 200 is actuated, such as by pressing on the fluid path element 106 toward the distal end 206 of the disinfecting cap 200, the distal end of the lumen 112 of the fluid path element 106 presses on the sealing member 282, thereby sealing the inner portion of the lumen 112 and deflecting the thin flexible material 284. This movement reduces the volume of the internal fluid volume and compresses the compressible absorbent material 214 and the disinfecting fluid contained therein. The pressurized fluid then presses on the thin flexible material 284, deflecting the material in the proximal direction and allowing the disinfecting fluid to flow through the thin flexible material and contact one or more outer surfaces of the fluid path element 106. Contact of the disinfecting fluid with the various surfaces of the fluid path element 106 for a predetermined length of time, such as from a few seconds to a maximum of 7 days, effectively disinfects the contacted surfaces.

[0094] Referring to FIG. 10A, the disinfecting cap 200 may include a proximal end 204 having an inner diameter D1 that is larger than the inner diameter D2 of the closed distal end 206. As described herein, the distal end 206 may include an inner fluid reservoir 280 defined by the closed distal end 206, the distal portion of the side wall 208, and the sealing member 282. The inner fluid reservoir 280 may be filled with a disinfecting fluid or an absorbent material 214 that is at least partially saturated with a disinfecting fluid, as described herein.

[0095] The sealing member 282 may include a flexible flange 286 that extends around at least a portion of the circumference of the fluid path sealing portion 222. The sealing member 280 may be sealingly seated against a lip 288 formed at the transition from the large inner diameter D1 to the small inner diameter D2, and thus prevent the release of the disinfection fluid from the inner fluid reservoir 280 when the disinfection cap 280 is in the inoperative state. As described herein, the pressure in the lumen 112 of the fluid path element 106 on the proximal sealing surface of the sealing member 282 may create a fluid-tight seal between the interior of the lumen 112 and the fluid path sealing surface 222. Further pressure on the fluid path element 106 against the sealing member 282 in the distal direction may break the seal between the sealing member 282 and the lip 288, and with the bending of the flexible flange 286, press the sealing member 282 into the internal volume of the distal end 206. Due to the accompanying pressure increase on the disinfection fluid or on the compressible absorbent material at least partially saturated with the disinfection fluid, the disinfection fluid is released towards the fluid path element 106 around the circumference of the bent flexible flange 286, coats one or more outer surfaces of the lumen 112 and the surface of the fluid path element 106, and sterilizes the ends of the fluid path element 106. In certain embodiments, the disinfection cap 200 may further include a ring 290 of absorbent material disposed around at least a portion of the inner circumference of the large-diameter proximal section of the disinfection cap 200. The ring 290 of absorbent material (see FIG. 10B) can help hold the seal between the sealing member 282 and the lip 288, contact the outer surface of the fluid path element 106, absorb excess disinfection fluid, and ensure that the fluid path element 106 is completely coated with the disinfection fluid.

[0096] Referring to FIGS. 11A - 11B, the distal end 113 of the fluid path element 106 may include a mechanism for preventing microbial or pathogenic contamination of the lumen 112 of the fluid path element 106 by one or more movable elements. For example, in a first embodiment, the fluid path element 106 may include a cover 130 for preventing contamination of the lumen 112 and preventing fluid dripping from the end of the fluid path element 106. The cover 130 may include a shroud 160 having a movable protective abutment 162 and a compressible side cover 166. As shown in FIGS. 11A - 11B, the distal end 113 of the fluid path element 106 has a shroud 160 surrounding the fluid path element 106. The distal end of the shroud 160 has a movable two - piece structure with a sealing protective abutment 162 disposed on the lumen 112. The single - patient fluid path set 108 may have a pair of flexible legs 121 configured to pivot radially outwardly about a pivot point 123. When the ends of the extending flexible legs 121 of the single - patient fluid path set 108 contact the distal surface of the shroud 160 and the flexible legs 121 press the sealing protective abutment 162, the sealing protective abutment 162 moves from a covered position (FIG. 11A) to an uncovered position (FIG. 11B). Then, when the lumen 129 of the single - patient fluid path set 108 engages the lumen 112 of the fluid path element 106, the compressible side cover 166 is compressed from an uncompressed position (FIG. 11A) to a compressed position (FIG. 11B).

[0097] Referring to FIGS. 12A - 12B, the cover 130 may be provided at the distal end of the single - patient fluid path set 108. For example, the compressible side cover 166 may extend around the lumen 129 of the single - patient fluid path set 108 and may be configured to be compressed in the proximal direction when the lumen 112 of the fluid path element 106 contacts the sealing protective abutment 162, thereby shifting the two - piece structure from a covered position (FIG. 12A) to an uncovered position (FIG. 12B). When the lumen 112 of the fluid path element 106 engages the lumen 129 of the single - patient fluid path set 108, the compressible side cover 166 is compressed from an uncompressed position (FIG. 12A) to a compressed position (FIG. 12B).

[0098] When the single-patient fluid path set 108 engages with the multi-patient fluid path elements 106, the single-patient fluid path set 108 moves the flexible engagement leg 121 radially outward. When the engagement leg 121 flexes outward, the silicone sealing member moves radially apart, enabling access to the lumen 112 of the multi-patient fluid path elements 106, and as a result, the single-patient fluid path set 108 can be engaged therewith.

[0099] Referring to FIGS. 13A-13C, the housing 202 of the sterilization cap 200 may include a sealing lip 292 that extends radially inward from the inner surface 228 of the side wall 208. The sealing lip 292 is disposed between the open proximal end 204 and the closed distal end 206 within the internal volume 210 of the housing 202. The slidable plunger 250 may be sealingly seated proximal to the sealing lip 292 such that a distal fluid volume 294 is defined by the distal portion of the side wall 208, the slidable plunger 250, and the closed distal end 206. The inner surface 228 of the side wall 208 may include a plurality of longitudinal grooves or protrusions 296 that define a fluid passage for the sterilization fluid to flow. In some embodiments, the plurality of longitudinal grooves or protrusions 296 may be spaced at equal or unequal angular intervals. The distal fluid volume 294 may include a compressible absorbent material, such as the compressible absorbent material 214 that is at least partially saturated with the sterilization fluid as described herein with reference to FIGS. 2A-2F. Alternatively, the distal fluid volume 294 may simply contain a volume of the sterilization fluid that is sealingly retained within the distal fluid volume 294 by the slidable plunger 250.

[0100] When the disinfection cap 200 releasably engages the distal end of the fluid path element 106, the fluid path element 106 contacts the slidable plunger 250 in a first non-operating state. In certain embodiments, the slidable plunger 250 may form a fluid-tight seal against the distal end of the lumen 112 of the fluid path element 106, as described herein, thereby sealing the lumen 112 and preventing contamination of the lumen 112 and / or dripping of fluid from the lumen 112. Moving the disinfection cap 200 from the first non-operating state to the second operating state includes pressing the disinfection cap 200 further onto the fluid path element 106 such that the fluid path element 106 is further inserted into the internal volume 210 of the housing 202 towards the closed distal end 206. Further movement of the disinfection cap 200 relative to the fluid path element 106 may press the slidable plunger 250 beyond the sealing lip 292, thereby reducing the volume of the distal fluid volume 294 and pressurizing the disinfection fluid contained therein.

[0101] When the slidable plunger 250 is pressed beyond the proximal ends of the plurality of longitudinal grooves or longitudinal protrusions 296 via the movement of the fluid path element 106 (FIG. 13C), the disinfection fluid can flow past the slidable plunger through the plurality of longitudinal grooves or around the plurality of longitudinal protrusions 296 so that the disinfection fluid can contact the outer surface of the fluid path element 106. Contact of the disinfection fluid with the various surfaces of the fluid path element 106 over a predetermined length of time, such as from a few seconds to a maximum of 7 days, effectively disinfects the contacted surfaces.

[0102] Referring to FIGS. 14A - 14D, the disinfection cap 200 may have a slidable plunger 250 (shown in FIGS. 14B - 14D) having an inner sealing member 298 that forms a circumferential seal with an inner surface sealing seat 300 defined by the inner surface 228 of the housing 202. When the disinfection cap 200 is pressed towards the fluid path element 106 to the operating position, the inner sealing member 298 moves towards the closed distal end 206 of the housing 202 so as not to contact the inner surface sealing seat 300. Similar to the embodiments described herein with reference to FIGS. 13A - 13C, the inner surface 228 of the distal sidewall 208 of the inner surface sealing seat 300 may include a plurality of longitudinal grooves or protrusions 296 that define a fluid passage for the disinfection fluid to flow. When the slidable plunger 250 is pressed distally from the inner surface sealing seat 300, the disinfection fluid contained in the distal fluid volume 294 can flow proximally towards the fluid path element 106 through the plurality of longitudinal grooves or protrusions 296.

[0103] As preferably shown in FIG. 14B, in both the non - operating position when the lumen 112 first contacts the slidable plunger 250 and the operating position when the fluid path element 106 presses the slidable plunger 250 distally towards the closed distal end 206, the slidable plunger 250 has an extension mechanism 302 that defines a fluid path sealing surface 222 configured to seal the lumen 112 of the fluid path element 106.

[0104] Referring to FIGS. 15A - 15E, a disinfection cap 200 according to another embodiment of the present disclosure is shown. As preferably shown in FIG. 15C, the housing 202 of the disinfection cap 200 has a lateral opening 304 between an open proximal end 204 and a closed distal end 206. The lateral opening 304 extends through the side wall 208 of the housing 202 into the internal volume 210 of the housing 202. In some embodiments, the lateral opening 304 may be configured to receive an insertable tray 306 (shown in FIGS. 15B and 15E) that houses a compressible absorbent material 214. The lateral opening 304 has at least one lateral groove 308 configured to receive at least a portion of the insertable tray 306 that enables a pivoting movement of the tray 306 relative to the housing 202 to provide a polishing action between the compressible absorbent material 214 and the surface of the fluid path element 106 when the tray 306 is inserted into the housing 202 and contacts the surface of the fluid path element 106.

[0105] Referring to FIG. 15E, the insertable tray 306 has a receiving portion 310 configured to receive a compressible absorbent material 214 (shown in FIG. 15D) at least partially saturated with a disinfecting material, and a handling tab 312 extending radially outward from the receiving portion 310. The receiving portion 310 may be sized to be received within the lateral opening 304, while the handling tab 312 may be configured to be received within the lateral groove 308 of the lateral opening 304 during the pivoting operation. The insertable tray 306 may be inserted into the internal volume 210 of the housing 202 through the lateral opening 304 by sliding the insertable tray 306 in a direction perpendicular to the longitudinal axis L (shown in FIG. 15B). Once inserted, the insertable tray 306 may be reciprocally pivoted or rotated in a direction about the longitudinal axis L by the user gripping the handling tab 312 to provide a rubbing action between the compressible absorbent material 214 and the fluid path element 106. The compressible absorbent material 214 and the insertable tray 306 may have corresponding anti-rotation slots 242 and anti-rotation protrusions 244 as described herein to prevent rotation of the compressible absorbent material 214 relative to the insertable tray 306.

[0106] As shown in FIG. 15E, a compressible absorbent material 214 can be sealed within a tray 306, and a removable seal 314 for holding a disinfection fluid can be provided on the insertable tray 306. The removable seal 314 may be removed before inserting the insertable tray 306 into the disinfection cap 200. In another embodiment, the insertable tray 306 and the compressible absorbent material 214 may be provided without a disinfection fluid, and the removable seal 314 may be provided to maintain the sterility of the internal volume of the insertable tray 306. Before inserting into the disinfection cap 200, the removable seal 314 may be removed, and the compressible absorbent material 214 may be saturated with a disinfection fluid from a bulk fluid source. In certain embodiments, the compressible absorbent material 214 may be provided in a form that defines a central opening 216 that substantially corresponds to the outer diameter of the lumen 112 of the fluid path element 106. While the compressible absorbent material 214 is in contact with the fluid path element 106, the lumen 112 of the fluid path element 106 may not be in contact with the compressible absorbent material 214. In other embodiments, the compressible absorbent material 214 may not include a central opening 216.

[0107] Referring to FIGS. 16A-16B, the disinfection cap 200 may include a slidable plunger 250 having an internal chamber 316 configured to contain any volume of disinfection fluid. The slidable plunger 250 may be configured to reciprocate in a direction along the longitudinal axis L within the internal volume 210 of the housing 202. The slidable plunger 250 has a cylindrical body 318 having a pair of retaining flanges 320 that interact with a distal flange 322 at the open distal end 252 of the housing 202 to define movement of the slidable plunger 250 relative to the housing 202. In some embodiments, the slidable plunger 250 may be further configured for rotational movement about the longitudinal axis L.

[0108] Continuing to refer to FIGS. 16A-16B, the proximal end portion 324 of the slidable plunger 250 is connected to the compressible absorbent material 214. For example, the compressible absorbent material 214 may have a groove 326 configured to receive the proximal retaining flange 320 of the slidable plunger 250. In this way, the compressible absorbent material 214 is movable along with the movement of the slidable plunger 250. When the sterilization cap 200 is connected to the fluid path element 106, the internal volume 316 of the slidable plunger 250 may be filled with the sterilization fluid so that the sterilization fluid at least partially saturates the compressible absorbent material 214. When the user grips the distal retaining flange 320 and the gripping element 212, etc., and the slidable plunger 250 moves axially in a direction toward and away from the fluid path element 106 along the longitudinal axis L, the compressible absorbent material 214 contacts the fluid path element 106 to sterilize the fluid path element 106. In some embodiments, the slidable plunger 250 may be further rotated about the longitudinal axis L to abrade the fluid path element 106.

[0109] Referring to FIGS. 17A-17C, a sterilization cap 200 according to another embodiment, which is a variation of the embodiment shown in FIGS. 16A-16B, is shown. As shown in FIGS. 16A-16B, instead of a cylindrical body 318 having a uniform diameter throughout its length, the proximal end portion 324 of the slidable plunger 250 may have a wider diameter compared to the diameter of the cylindrical body 318. In some embodiments, the proximal end portion 324 may define a receiving cavity 328 for receiving the compressible absorbent material 214 therein. As described herein, the compressible absorbent material 214 may include a circumferential groove 246 for engaging the outer skirt 116 of the fluid path element 106. The wider diameter of the portion of the side wall 208 of the sterilization cap 200 may further act as the gripping element 212 when compressing the slidable plunger 250.

[0110] Referring to FIGS. 18A - 18B, the disinfection cap 200 may include a housing 202 having an open proximal end 204, a closed distal end 206, and a side wall 208 extending between the open proximal end 204 and the closed distal end 206 and defining an internal volume 210 (shown in FIG. 18B). The compressible absorbent material 214 is held within the internal volume 210 and is connected to the closed distal end 206 via an adhesive pad 330. In some embodiments, the adhesive pad 330 may include a low - melting polymer. The proximal end of the compressible absorbent material 214 may include a fluid - impermeable coating configured to sealingly engage the lumen 112 of the fluid path element 106 to prevent the entry of the disinfection fluid into the fluid path of the lumen 112. For example, the fluid - impermeable coating may include a layer of closed - cell polymer, a silicone layer, a polymer layer, or other suitable material adhered to the proximal end of the compressible absorbent material 214. The closed distal end 206 may have a retainer 331, such as a peripheral wall protruding proximally from the closed distal end 206, to hold the compressible absorbent material 214.

[0111] Referring to FIGS. 19A - 19B, a disinfection cap 200 according to another embodiment of the present disclosure is shown. The inner surface 228 of the housing 202 may have one or more protrusions 332 protruding radially inward from the inner surface 228. The one or more protrusions 332 may extend along at least a portion of the longitudinal length of the housing 202 in the direction of the longitudinal axis L. In some embodiments, the one or more protrusions 332 may be configured as helical threads configured to threadedly engage corresponding threads on the compressible absorbent material 214. In other embodiments, the one or more protrusions 332 may be configured to compressively hold the compressible absorbent material 214, such as by an interference fit. As described herein, the proximal end of the compressible absorbent material 214 may include a fluid - impermeable coating configured to sealingly engage the lumen 112 of the fluid path element 106 to prevent the entry of the disinfection fluid into the fluid path of the lumen 112.

[0112] Referring to FIGS. 20A - 20D, a disinfection cap 200 according to another embodiment of the present disclosure is shown. The closed distal end portion 206 may have a retaining pocket 334 configured to hold the compressible absorbent material 214. In some embodiments, the retaining pocket 334 may have an inner diameter that is smaller compared to the diameter of the inner surface 228 of the housing 202. The inner diameter of the retaining pocket 334 may be substantially the same as the outer diameter of the compressible absorbent material 214. The retaining pocket 334 may have one or more undercut portions 336, for example, at the transition from the retaining pocket 334 and the inner surface 228 of the housing 202 or at other locations within the retaining pocket 334, to securely engage and hold the distal end portion of the compressible absorbent material 214 within the retaining pocket 334.

[0113] In some embodiments, the retaining pocket 334 may include one or more longitudinal ribs 338 that extend radially inward and are configured to engage the side surfaces of the compressible absorbent material 214. The one or more longitudinal ribs 338 may prevent rotation of the compressible absorbent material 214 when the disinfection cap 200 is rotated relative to the fluid path element 106 (shown in FIGS. 21C - 21D) to create a rubbing effect between the fluid path element 106 and the compressible absorbent material 214 so as to affect the disinfection action of the fluid path element 106. In certain embodiments, a fluid - impermeable coating or film 340 may be attached to the proximal surface of the compressible absorbent material 214 to act as a blocker to prevent the disinfection fluid from the compressible absorbent material 214 from moving into the lumen 112 of the fluid path element 106. According to these embodiments, the film 340 may be attached or adhered to the surface of the compressible absorbent material 214 by an adhesive, co - molding, or melting process on the front surface of the compressible absorbent material 214, for example, to close the continuous cells of the compressible absorbent material 214 and block the flow of fluid through that portion of the surface of the compressible absorbent material 214.

[0114] Referring to FIG. 21, the disinfection cap 200 may include an outer cylindrical sleeve 342 that surrounds the compressible absorbent material 214. The outer cylindrical sleeve 342 may be made of the same material as the compressible absorbent material 214. In this embodiment, the compressible absorbent material 214 can provide a polishing and disinfection effect to the inner portion of the fluid path element 106 (shown in FIG. 1B), while the outer cylindrical sleeve 342 can provide a polishing and disinfection effect to the outer portion of the fluid path element 106. The outer cylindrical sleeve 342 may be held by one or more retaining undercuts 336 that project from the inner surface 228 of the housing 202. As described herein, a fluid-impermeable coating configured to sealingly engage the lumen 112 of the fluid path element 106 to prevent the entry of disinfection fluid into the fluid path of the lumen 112 may include the proximal end of the compressible absorbent material 214.

[0115] Referring to FIGS. 22A-22B, the disinfection cap 200 may have a uniform inner diameter between the open proximal end 204 and the closed distal end 206. At least a portion of the inner surface 228 of the housing 202 may have one or more longitudinal ribs 338 that project radially inward from the inner surface 228. In some embodiments, the one or more longitudinal ribs 338 are configured to engage the compressible absorbent material 214 to prevent rotation of the compressible absorbent material 214 relative to the housing 202 during the twisting action of the disinfection cap 200 relative to the fluid path element 106 (shown in FIG. 1B) that affects the polishing action on the fluid path element 106. As described herein, a fluid-impermeable coating configured to sealingly engage the lumen 112 of the fluid path element 106 to prevent the entry of disinfection fluid into the fluid path of the lumen 112 may include the proximal end of the compressible absorbent material 214.

[0116] Referring to FIGS. 23A - 23D, a disinfection cap 200 according to another embodiment of the present disclosure is shown. The compressible absorbent material 214 in FIGS. 23A - 23B has a central opening 216, while the compressible absorbent material 214 in FIGS. 23C - 23D has a protruding fluid path sealing surface 222. The compressible absorbent material 214 in either of the two embodiments may have a fluid - impermeable coating, film, or laminated material 344 adhered or otherwise attached to the proximal surface 248 of the compressible absorbent material 214 as described herein. In some embodiments, the film or laminated material 344 may cover the entire proximal surface 248 such that the film or laminated material 344 extends substantially to the outer periphery of the compressible absorbent material 214. According to certain embodiments, the film or laminated material 344 may include one or more perforations 346 that allow a disinfection fluid to flow from the compressible absorbent material 214 through the film or laminated material 344 and contact the fluid path element 106 to disinfect the surface of the fluid path element 106.

[0117] In other embodiments, a first portion of the film or laminated material 344 may be adhered to the central region of the compressible absorbent material 214, and it is desirable that the remaining portion of the film or laminated material 344 is not adhered to the compressible absorbent material 214. According to these embodiments, when the fluid path element 106 (shown in FIG. 1B) is inserted into the disinfection cap 200 and compresses the compressible absorbent material 214, the non - adhered portion of the film or laminated material 344 (i.e., the peripheral portion) moves away from the compressible absorbent material 214 and folds around the fluid path element 106. When the film or laminated material 344 is folded, a passage is defined between the fluid path element 106 and the inner surface 228 of the disinfection cap 200, thereby allowing the disinfection fluid to flow from the compressible absorbent material 214 toward at least a portion of the fluid path element 106 and contact the fluid path element 106 for disinfection.

[0118] Referring to FIGS. 24A - 24C, a disinfection cap 200 according to another embodiment of the present disclosure is shown. As shown in FIG. 24A, the disinfection cap 200 includes a housing 202 having an open proximal end 204, a closed distal end 206, and a side wall 208 extending between the open proximal end 204 and the closed distal end 206 and defining an internal volume 210. The disinfection cap 200 has an inner sleeve 348 protruding from the inner surface 350 of the closed distal end 206. In some embodiments, the inner sleeve 348 has a cylindrical shape and extends into the internal volume 210 over at least a portion of the longitudinal length of the housing 202. In certain embodiments, the distal end of the inner sleeve 348 is recessed with respect to the open proximal end 204. The inner sleeve 348 defines a receiving space 352 (shown in FIG. 24C) for receiving the lumen 112 of the fluid path element 106. The space 354 between the inner cylindrical sleeve 348 and the inner surface 228 of the side wall 208 is configured to receive the compressible absorbent material 214. In some embodiments as shown in FIG. 24A, the compressible absorbent material 214 may be recessed within the space 354, while in other embodiments as shown in FIG. 24D, the compressible absorbent material 214 may protrude proximally from the space 354 with respect to the distal end of the inner sleeve 348. In another embodiment, the compressible absorbent material 214 may terminate distally of the proximal end of the inner sleeve 348. According to this aspect, the disinfection fluid may be shielded by the inner sleeve 348 of the disinfection cap 200 and prevented from being squeezed from the compressible absorbent material 214 before the lumen 112 of the fluid path element 106 can be sealingly received in the receiving space 352, for example, by an interface between a sealing O - ring on the lumen 112 and the inner side wall of the inner sleeve 348.

[0119] In some embodiments, the inner sleeve 348 may be configured to effect a seal with the lumen 112 of the fluid path element 106 to prevent contact of the disinfection fluid with the lumen 112. In some embodiments, the outer surface of the lumen 112 may have a seal portion 140 configured to contact the inner surface of the inner sleeve 348 to prevent the ingress and egress of fluid to and from the lumen 112.

[0120] Referring to FIG. 24F, the outer surface 356 of the inner sleeve 348 contacts at least a portion of the compressible absorbent material 214 and may have one or more retaining ribs 358 configured to hold the compressible absorbent material 214 in a fixed position relative to the inner sleeve 348 during rotation of the disinfection cap 200 relative to the fluid path element 106 (shown in FIG. 24C). The one or more retaining ribs 358 may extend axially along the longitudinal length of the inner sleeve 348.

[0121] According to another embodiment of the disinfection cap 200 having an inner sleeve 348, the compressible absorbent material 214 may be held within the space 354 between the inner sleeve 348 and the side wall 208, and the proximal end of the compressible absorbent material 214 is in the same plane as the proximal end of the disinfection cap, enabling disinfection of the fluid path element 106 without moving any microbial substances towards the rear of the fluid path element 106.

[0122] Referring to FIG. 25, the disinfection cap 200 may include an outer cylindrical sleeve 342 surrounding the compressible absorbent material 214. The outer cylindrical sleeve 342 may be made of the same material as the compressible absorbent material 214 and may be divided by a cylindrical cut substantially along the length of the outer cylindrical sleeve 342, the cut being configured to receive the outer skirt 116 of the fluid path element 106. In this embodiment, the compressible absorbent material 214 can provide a polishing and disinfection effect on the inner portion of the fluid path element 106, while the outer cylindrical sleeve 342 can provide a polishing and disinfection effect on the outer portion of the fluid path element 106. The outer cylindrical sleeve 342 may be held by one or more retaining undercuts protruding from the inner surface 228 of the housing 202. Further, in other embodiments, when the disinfection cap 200 is twisted relative to the fluid path element 106, the divided compressible absorbent material 214 can provide a rotational polishing effect. Certain embodiments may include one or more longitudinal ribs to prevent relative movement of the compressible absorbent material 214 and / or the outer cylindrical sleeve 342 during twisting and polishing movements, as described herein.

[0123] Referring to FIGS. 26A-26B, a disinfection cap 200 according to another embodiment of the present disclosure is shown. The inner surface 360 of the inner sleeve 348 may include one or more clip mechanisms 362 configured to project radially inward and releasably engage at least a portion of the lumen 112 of the fluid path element 106. In some embodiments, the one or more clip mechanisms 362 may be configured as continuous or discontinuous ribs extending around the inner circumference of the inner sleeve 348. The one or more clip mechanisms 362 can hold the disinfection cap 200 connected to the fluid path element 106 and resist the restoring force from the compressed absorbent material 214, whereby the disinfection cap 200 is held on the fluid path element 106 for at least an appropriate amount of time for the disinfection fluid to disinfect any microbial contaminants on the surface of the fluid path element 106. In certain embodiments, the one or more clip mechanisms 362 may also provide the user with tactile and / or audible feedback that the disinfection cap 200 is properly installed on the fluid path element 106.

[0124] Referring to FIGS. 27A - 27B, the outer surface 356 of the inner sleeve 348 may include one or more clip mechanisms 362 configured to project radially outward and releasably engage at least a portion of the lumen 112 of the fluid path element 106. In some embodiments, the one or more clip mechanisms 362 may be configured as continuous or discontinuous ribs extending around the outer periphery of the inner sleeve 348. The one or more clip mechanisms 362 may be configured to engage a ledge 152 on an opening 114 of the outer skirt 116 of the fluid path element 106. The one or more clip mechanisms 362 can hold a disinfection cap 200 connected to the fluid path element 106 and resist the restoring force from the compressed absorbent material 214, whereby the disinfection cap 200 is held on the fluid path element 106 for at least an appropriate time for the disinfection fluid to disinfect any microbial contaminants on the surface of the fluid path element 106. In certain embodiments, the one or more clip mechanisms 362 may also provide tactile and / or audible feedback to the user that the disinfection cap 200 is properly installed on the fluid path element 106.

[0125] Referring to FIG. 27C, the inner sleeve 348 may have a width that substantially corresponds to the width of the space 354 between the lumen 112 and the outer skirt 116 of the fluid path element 106. In some embodiments, the outer surface 354 of the inner sleeve 348 may have a piloting feature similar to one or more retaining ribs 358 extending in the longitudinal direction of the inner sleeve 348. The piloting feature can help prevent soiling or movement of microbial contaminants from the end portion of the fluid path element 106 towards the inner lumen 112.

[0126] Referring to FIGS. 28A-28B, the disinfection cap 200 may include a housing 202 having an inner sleeve 348 that projects proximally from the distal end 206. In some embodiments, the internal volume 210 may not include a compressible absorbent material, for example, according to any of the various non-limiting embodiments described herein. Two or more arms 364 extend proximally from the housing 202 and are configured to connect the housing 202 to the fluid path element 106. In some embodiments, the proximal end of each arm 364 has a retaining clip 366 (shown in FIG. 28B) configured to engage at least a portion of the fluid path element 106, such as the proximal end of the fluid path element 106, to hold the disinfection cap 200 on the fluid path element 106. The lumen 112 of the fluid path element 106 may be sized to fit within the internal volume 210 of the housing 202 such that the disinfection fluid within the internal volume 210 can contact the lumen 112.

[0127] Continuing to refer to FIGS. 28A-28B, the distal end 206 of the housing 202 has an opening 368 configured to fluidly connect to a reservoir. In some embodiments, the reservoir may be configured to contain any volume of disinfection fluid that can be delivered to the internal volume 210 of the housing 202 via the opening 368. The reservoir may be removably connectable to the housing 202 via one or more connecting legs 372. The reservoir may have a squeezable pouch made of a flexible material such that when the squeezable pouch is squeezed by the user, the disinfection fluid exits the reservoir, enters the internal volume 210 of the housing 202 via the opening 368, and disinfects the lumen 112.

[0128] Referring to FIGS. 28C - 28D, the disinfection cap 200 may include a housing 202 having an inner sleeve 348 that projects proximally from the distal end 206. In some embodiments, the internal volume 210 may not include a compressible absorbent material, for example, as according to any of the various non - limiting embodiments described herein. The lumen 112 of the fluid path element 106 may be sized to fit within the internal volume 210 of the housing 202 such that the disinfection fluid within the internal volume 210 can contact the lumen 112. The distal end 206 of the housing 202 has an opening similar to the opening 368 shown in FIGS. 28A - 28B, which is configured to be in fluid connection with the reservoir 370. In some embodiments, the reservoir 370 may be configured to contain any volume of disinfection fluid that can be delivered to the internal volume 210 of the housing 202 through the opening. The reservoir 370 may be removably connectable to the housing 202. In some embodiments, the reservoir 370 may be formed integrally (e.g., monolithically) with the housing 202. The reservoir 370 may have a squeezable pouch 374 made of a flexible material. In some embodiments, the reservoir 370 may be provided with a seal to initially seal the disinfection fluid within the reservoir 370. The seal may be configured to break when the squeezable pouch 374 is squeezed so that sufficient fluid pressure is built up within the reservoir 370. When the squeezable pouch 374 is squeezed by the user, the disinfection fluid exits the reservoir 370, enters the internal volume 210 of the housing 202, and disinfects the lumen 112.

[0129] Referring to FIG. 29, a disinfection cap 200 according to another embodiment is shown. The disinfection cap 200 has a housing 202 having an open proximal end 204 and an open distal end 252, each sealed by a sealing portion 232. The sealing portion 232 of the proximal end 204 may be removable by the user before connecting the disinfection cap 200 to the fluid path element 106 (shown in FIG. 1B). The sealing portion 232 of the open distal end 252 may be non-removably connected to the open distal end 252 to surround one or more windows 376 formed in the housing 202 to enable easy manufacture of the housing 202, such as by injection molding. The inner surface 228 of the housing 202 at the open distal end 252 may have one or more return mechanisms 378 configured to hold the compressible absorbent material 214 within the internal volume 210 of the housing 202. In use, the user first removes the sealing portion 232 at the open proximal end 204 of the disinfection cap 200 and attaches the disinfection cap 200 to the fluid path element 106 to disinfect the connector, for example, by a polishing and / or twisting action. In certain embodiments, the entire disinfection cap 200 may be made of a foam or adsorbent material and may be disposed within a foil or fluid-proof pouch, such as a container with a removable foil seal. The user removes the foil seal to access the foam cap and then uses the disinfection cap 200, for example, made of foam but having one or more of the mechanisms described herein, to disinfect the fluid path element 106. As described herein, the proximal end of the compressible absorbent material 214 may include a fluid-impermeable coating configured to sealingly engage the lumen 112 of the fluid path element 106 to prevent entry of the disinfection fluid into the fluid path of the lumen 112.

[0130] According to another embodiment as shown in FIGS. 30A - 30B, the disinfection cap 200 may include an elastic reservoir 380 that surrounds the inner sleeve 348. The elastic reservoir 380 may be filled with any volume of disinfection fluid. When the disinfection cap 200 is installed on the fluid path element 106 (shown in FIG. 1B), the elastic reservoir 380 can be compressed, thereby pressurizing the disinfection fluid within the elastic reservoir 380. When the disinfection fluid is compressed, the disinfection fluid may be forced to pass through the interface between the elastic reservoir 380 and the inner or outer surface of the inner sleeve 348. When the disinfection fluid exits the elastic reservoir 380, the fluid fills the space 354 between the housing 202 and the inner sleeve 348 and disinfects a portion of the fluid path element 106 held in the space 354. The proximal surface 382 of the elastic reservoir 380 may be configured to seal the lumen 112 of the fluid path element 106 (shown in FIG. 1B) and prevent the entry of disinfection fluid into the lumen 112.

[0131] In a particular embodiment as shown in FIGS. 31A - 31B, the disinfection cap 200 is shown according to another embodiment. The inner surface 228 of the side wall 208 of the disinfection cap 200 may include an oval rim 384 and / or an overall shape. The oval rim 384 may be defined by one or more protrusions at the proximal end 204 that define the proximal end 204 to have an oval shape. The oval rim 384 enables an improved snap function between the protrusions or retaining bumps 230 (shown in FIG. 2C) on the inner surface 228 of the disinfection cap 200 and the fluid path element 106 (shown in FIG. 1B). The oval rim 384 may be configured to bend into a circular shape when the disinfection cap 200 first contacts the fluid path element 106, allows passage of the fluid path element 106 during connection between the fluid path element 106 and the disinfection cap 200, and then bends back to its original oval shape to engage the protrusions or retaining bumps 230 with the fluid path element 106.

[0132] Referring to FIGS. 32A - 32B, a disinfection cap 200 according to another embodiment is shown. The sealing portion 232 of the housing 202 may have a guard 386, and a part of the guard is configured to be received within the interior 349 of the inner sleeve 348 when the sealing portion 232 is connected to the open proximal end portion 204 of the housing 202. The guard 386 may be formed as a separate component from the sealing portion 232 and then attached to the sealing portion 232 via an adhesive or the like. In other embodiments, the guard 386 may be integrally formed with the sealing portion 232 by molding or the like.

[0133] The compressible absorbent material 214 is received within the space 354 between the inner surface 228 of the housing 202 and the outer surface of the inner sleeve 348. In some embodiments, the guard 386 is configured to prevent the disinfection fluid contained within the compressible absorbent material 214 from entering the interior 349 of the inner sleeve 348, such as during transportation and / or storage of the disinfection cap 200. The guard 386 may have a stepped design having a first portion 351 configured to fit within the interior of the side wall 208 and having a first diameter, and a second portion 353 having a second diameter that is smaller than the first diameter and that projects distally from the first portion 351. The second portion 353 may be configured to be received within the interior 349 of the inner sleeve 348. A void 359 may be provided between the first portion 351 and the inner surface of the sealing portion 232 such that the guard 386 has a substantially uniform thickness between the first portion 351 and the second portion 353.

[0134] The inclined portion 357 may be provided at the transition between the first portion 351 and the second portion 353. The inclined portion 357 of the guard 386 engages with the proximal edge portion 355 of the inner sleeve 348 to form a fluid-tight seal, for example, to prevent the entry of the disinfection fluid from the compressible absorbent material 214 during transportation or storage. In this way, when the sealing portion 232 and the guard 386 are removed from the housing 202, there is no disinfection fluid inside the inner sleeve 348 that could normally enter the lumen 112 of the fluid path element 106 (shown in FIG. 1B) when the disinfection cap 200 is connected to the fluid path element 106. When the lumen 112 is inserted into the inner sleeve 348, a fluid-tight seal is formed between the sealing elements, for example, between the outer surface of the lumen 112 and the O-ring around the inner wall of the inner sleeve 348. As described herein, the compression of the compressible absorbent material 214 by the outer skirt 116 of the fluid path element 106 releases the disinfection fluid to disinfect the various exposed surfaces of the fluid path element 106. In certain embodiments, the side wall 202 of the proximal end portion 204 of the disinfection cap 200 may include an enlarged portion 395 to increase the surface area contact and adhesion between the proximal end of the side wall 202 and the sealing portion 232. The increased surface area contact and adhesion can prevent the unintentional breakage of the fluid-tight connection between the sealing portion 232 and the proximal end of the side wall 202, for example, during packaging, transportation, unpacking, and / or storage.

[0135] Referring to FIGS. 33A - 33B, the guard 386 may be held at the proximal end of the inner sleeve 348, for example, by a notch 388. In certain embodiments, the interior of the inner sleeve 348 may be filled with a disinfection fluid prior to the operation of the disinfection cap 200, and the guard 386 may seal the disinfection fluid within the interior 349 of the inner sleeve 348. In some embodiments, a compressible absorbent material similar to the compressible absorbent material 214 described herein with reference to FIGS. 2A - 2F and at least partially saturated with the disinfection fluid may fill at least a portion of the interior 349 of the inner sleeve 348. The proximal end of the guard 386 may include a fluid-impermeable coating configured to sealingly engage the lumen 112 of the fluid path element 106 to prevent the entry of the disinfection fluid into the fluid path of the lumen 112, as described herein.

[0136] When the fluid path element 106 is first connected to the disinfection cap 200 (FIG. 33B), the lumen 112 of the fluid path element 106 contacts the guard 386 such that the interior of the lumen 112 is sealed by the proximal surface of the guard 386. As the fluid path element 106 is further pressed distally into the interior volume 210 of the disinfection cap 200, the guard 386 is displaced from the notch 388 and moves toward the distal end 206 of the housing 202. Such movement of the guard 386 displaces the disinfection fluid from the interior 349 of the inner sleeve 348 around the guard 386 into the space 354, disinfecting the surface of the fluid path element 106.

[0137] In another embodiment, as described in accordance with various embodiments herein, the interior of the inner sleeve 348 may not contain the disinfection fluid, and the interior volume 210 may contain the disinfection fluid, such as being substantially absorbed by the cylindrically oriented compressible absorbent material 214 in the space 354 between the inner sleeve 348 and the inner surface 228 of the side wall 208. When the lumen 112 contacts the guard 386, the lumen 112 is sealed from the entry of the disinfection fluid. Further installation of the cap compresses the compressible absorbent material 214, releasing the disinfection fluid and bringing it into contact with portions of the fluid path element 106.

[0138] Referring to FIG. 34A, a plurality of disinfection caps 200 may be connected to a sealing strip 390. For example, in any of the embodiments described where the disinfection cap 200 has a sealing portion 232, such as those described with reference to FIGS. 32A and 32B, the sealing portion 232 may be in the form of a sealing strip 390. FIG. 34A shows a disinfection cap 200 without a gripping element 212, but in some embodiments, a gripping element 212 may be provided on the disinfection cap 200. In some embodiments, the sealing strip 390 may extend across the open proximal end 204 of each disinfection cap 200 and surround its internal volume. The sealing strip 390 may be removably attached to and cover the open proximal end 204 of the disinfection cap 200, and may be an adhesive and / or frangible sealing portion. The sealing strip 390 enables the transportation and storage of the disinfection cap 200 without loss (e.g., evaporation) and / or contamination of the disinfection fluid within the internal volume of the housing 202. Each of the plurality of disinfection caps 230 may be removed one by one from the sealing strip 390, if desired, without affecting the sterility or condition of the remaining disinfection caps 200. As shown in FIG. 34A, each disinfection cap 200 may include an enlarged portion 395 at the proximal end of the side wall 202 to increase surface area contact and adhesion between the proximal end of the side wall 202 and the sealing portion 232. The increased surface area contact and adhesion may prevent unintentional breakage of the fluid tight connection between the sealing portion 232 and the proximal end of the side wall 202, for example, during packaging, transportation, unpacking, and / or storage. The sealing strip 390 may further include a hole 397 for suspending the sealing strip 390, for example, on a fluid injector or an IV pole, to enable easy access to the disinfection cap 200 during the setup of subsequent fluid injection procedures. Each sealing strip 390 may include any number of disinfection caps 200, but since the disinfection caps 200 are typically used in pairs for the disinfection of the corresponding ends of the contrast fluid line and the saline fluid line associated with the plurality of patient fluid path sets 104, each sealing strip 390 is considered to include an even number of disinfection caps 200.As shown in FIG. 34B, a plurality of sealing strips 390 having a plurality of disinfection caps 200 each connected thereto may be packaged in a box 392 for transportation and bulk storage.

[0139] Although various examples of the present disclosure have been provided in the foregoing description, those skilled in the art can make modifications and changes to these examples without departing from the scope and spirit of the present disclosure. Therefore, the foregoing description is intended to be illustrative rather than limiting. The above disclosure is defined by the appended claims, and all changes to the present disclosure that are within the meaning and equivalent scope of the claims shall be included within the scope of those claims.

Description of Reference Numerals

[0140] 100 Fluid path set, 102 Fluid reservoir, 104 Multiple patient fluid path set, 106 Fluid path element, 108 Single patient fluid path set, 110 Body, 111 Proximal end, 112 Lumen, 113 Distal end, 114 Opening, 116 Outer skirt, 118 Distal surface, 120 Corresponding engagement mechanism, 121 Flexible leg, 123 Pivot point, 129 Lumen, 130 Cover, 140 Sealing portion, 152 Ridge, 160 Shroud, 162 Movable protective abutment, 166 Compressible side cover, 200 Disinfection cap, 202 Housing, 204 Open proximal end, 206 Closed distal end, 208 Side wall, 210 Internal volume, 212 Gripping element, 214 Compressible absorbent material, 214a First compressible absorbent material, 214b Second compressible absorbent material, 216 Central opening, 218 Slidable insert, 220 Proximal surface, 222 Fluid path sealing surface, 224 Circumferential flange, 226 One or more passages, 228 Inner surface, 230 One or more protrusions, 232 Sealing portion, 234 Threaded distal end, 236 Proximal end, 238 Key, 242 One or more anti-rotation slots, 244 One or more anti-rotation protrusions, 246 Circumferential groove, 248 Proximal surface, 250 Slidable plunger, 252 Open distal end, 254 Inner flange, 255 One or more fluid passages, 256 Protrusion extending in the proximal direction, 258 Sealing surface, 260 Distal side, 262 Proximal side, 264 Pressing surface, 266 Proximal end, 268 One or more protrusions, 270 Threaded configuration, 272 Fluid reservoir, 274 Distal wall, 276 One or more pressure-operated passages, 278 Flexible and deformable elastomeric membrane, 280 Inner fluid reservoir, 282 Sealing member, 284 Thin flexible material, 286 Flexible flange, 288 Lip, 290 Ring, 292 Sealing lip, 294 Distal fluid volume, 296 Multiple longitudinal grooves or protrusions, 298 Inner sealing member, 300 Inner surface sealing seat, 302 Extension mechanism, 304 Lateral opening, 306 Insertable tray, 308 Lateral groove, 310 Receiving portion, 312 Handling tab, 314 Removable sealing portion, 316 Internal chamber, 318 Cylindrical body, 320 Pair of retaining flanges, 322 Distal flange, 324 Proximal end, 326 Groove, 328 Receiving cavity, 330 Adhesive pad, 331Retainer, 332 one or more protrusions, 334 holding pocket, 336 one or more undercut portions, 338 one or more longitudinal ribs, 340 fluid-impermeable coating or film, 342 outer cylindrical sleeve, 344 film or laminated material, 346 one or more perforations, 348 inner sleeve, 349 interior, 350 inner surface, 351 first portion, 352 receiving space, 353 second portion, 354 space, 355 proximal edge, 356 outer surface, 357 inclined portion, 358 one or more retaining ribs, 359 void, 360 inner surface, 362 one or more clip mechanisms, 364 arm, 366 retaining clip, 368 opening, 370 reservoir, 372 one or more connecting legs, 374 squeezable pouch, 376 one or more windows, 378 one or more return mechanisms, 380 elastic reservoir, 382 proximal face, 384 elliptical rim, 386 guard, 388 notch, 390 sealing strip, 392 box, 395 widened portion, 397 hole, D1 inner diameter, D2 inner diameter

Claims

1. A disinfection cap for a fluid path element, wherein the disinfection cap is A housing configured to fit into at least a portion of the fluid path element, wherein the housing comprises an open proximal end, a closed distal end, and a side wall extending between the open proximal end and the closed distal end to define the internal volume. A compressible absorbent material that is at least partially saturated with a disinfectant fluid, wherein the compressible absorbent material is located within the internal volume of the housing, An insert within the internal volume connected to the compressible absorbent material, wherein the insert is movable toward the closed distal end in order to compress the compressible absorbent material as the fluid path element moves toward the closed distal end, and the insert is A fluid path sealing portion configured to seal the lumen on the fluid path element, A circumferential flange extending around the fluid path sealing portion, wherein the circumferential flange has one or more passages configured to allow the flow of the disinfectant fluid from the compressible absorbent material to the fluid path element when the insert is biased toward the closed distal end by the fluid path element, An insert equipped with, A disinfectant cap equipped with this feature.

2. The disinfectant cap according to claim 1, wherein the inner surface of the side wall is provided with one or more radially inwardly projecting projections, the projections being configured to removably engage with the fluid path element and to hold the disinfectant cap on the fluid path element.

3. The disinfectant cap according to claim 1 or 2, wherein the movement of the insert toward the closed distal end via the movement of the fluid path element compresses the compressible absorbent material and releases at least a portion of the disinfectant fluid through one or more passages so that the disinfectant fluid comes into contact with at least a portion of the fluid path element.

4. The disinfection cap according to any one of claims 1 to 3, wherein the circumferential flange is attached to the inner surface of the side wall of the housing.

5. The disinfectant cap according to any one of claims 1 to 4, wherein the fluid path sealing portion comprises a rubber material, a flexible plastic material, or a silicone material, configured to create a fluid seal between the fluid path element and the lumen.

6. The disinfection cap according to any one of claims 1 to 5, further comprising a gripping flange protruding distally from the closed distal end.

7. The disinfectant cap according to any one of claims 1 to 6, further comprising a sealing portion removably connected to the open proximal end, wherein the sealing portion fluidly seals the open proximal end.

8. A disinfection cap for a fluid path element, wherein the disinfection cap is A housing configured to fit into at least a portion of the fluid path element, wherein the housing comprises an open proximal end, an open distal end, and a side wall extending between the open proximal end and the open distal end, A flange extending across the interior of the housing between the open proximal end and the open distal end, wherein the flange has one or more openings, A compressible absorbent material at least partially saturated with a disinfectant fluid, wherein the compressible absorbent material is located at the distal end of the flange, A plunger connected to the housing so as to surround the open distal end, wherein the plunger is slidably movable relative to the housing between the open distal end and the open proximal end, Equipped with, The proximal movement of the plunger compresses the compressible absorbent material and releases at least a portion of the disinfectant fluid through one or more openings. Disinfectant cap.

9. The disinfectant cap according to claim 8, wherein the plunger comprises a foldable fluid sphere for containing the disinfectant fluid, and the foldable fluid sphere is foldable by a proximal pressing motion to distribute the disinfectant fluid into the housing through one or more holes at the proximal end of the plunger.

10. The disinfectant cap according to claim 8 or 9, wherein the inner surface of the side wall is provided with one or more radially inwardly projecting projections, the projections being configured to removably engage with the fluid path element and to hold the disinfectant cap on the fluid path element.

11. The disinfectant cap according to any one of claims 8 to 10, further comprising a sealing portion that is detachably connected to the open proximal end.

12. A disinfection cap for a fluid path element having an inner lumen and an outer cylindrical wall surrounding the inner lumen, wherein the disinfection cap is A housing configured to receive the inner lumen and outer cylindrical wall of the fluid path element, wherein the housing comprises an open proximal end, a closed distal end, and a side wall extending between the open proximal end and the closed distal end to define the internal volume. A sleeve protruding proximally from the inner surface of the closed distal end, the sleeve defining an opening configured to receive the inner lumen of the fluid path element, A compressible absorbent material at least partially saturated with a disinfectant fluid, wherein the compressible absorbent material is placed within the internal volume of the housing and surrounds at least a portion of the outer part of the sleeve, Equipped with, The outer cylindrical wall of the fluid path element is configured to receive the disinfection space such that the movement of the fluid path element toward the closed distal end compresses the compressible absorbent material and releases at least a portion of the disinfectant fluid into the disinfection space between the inner surface of the housing and the sleeve. Disinfectant cap.

13. The disinfection cap according to claim 12, wherein the inner surface of the sleeve is configured to seal and engage with the inner lumen of the fluid path element.

14. The disinfectant cap according to claim 12 or 13, wherein the compressible absorbent material substantially extends from the closed distal end to the open proximal end of the housing.

15. The disinfectant cap according to any one of claims 12 to 14, wherein the sleeve comprises one or more longitudinal ribs, the longitudinal ribs protruding radially outward and engaging with the compressible absorbent material surrounding the outer portion of the sleeve to prevent rotation of the compressible absorbent material relative to the sleeve.

16. The disinfectant cap according to any one of claims 12 to 15, wherein the compressible absorbent material has an axial slot configured to receive the outer cylindrical wall of the fluid path element.

17. The disinfectant cap according to any one of claims 12 to 16, wherein the sleeve comprises a tab configured to provide tactile or auditory feedback when the inner lumen of the fluid path element is fully inserted into the sleeve.

18. The disinfectant cap according to any one of claims 12 to 17, wherein the inner surface of the side wall is provided with one or more radially inwardly projecting projections, the projections being configured to removably engage with the outer cylindrical wall and to hold the disinfectant cap on the fluid path element.

19. The disinfectant cap according to any one of claims 12 to 18, wherein the compressible absorbent material is a sponge.

20. The disinfectant cap according to any one of claims 12 to 18, wherein the compressible absorbent material is cotton.

21. The disinfectant cap according to any one of claims 12 to 20, wherein the disinfectant fluid comprises isopropyl alcohol, ethanol, a combination thereof, or an aqueous solution thereof.

22. The disinfection cap according to any one of claims 12 to 21, further comprising a gripping flange protruding distally from the closed distal end.

23. The disinfectant cap according to any one of claims 12 to 22, further comprising a sealing portion removably connected to the open proximal end, wherein the sealing portion fluidly seals the open proximal end.

24. The disinfectant cap according to claim 23, wherein the sealing portion includes a pull tab that protrudes radially outward from the side wall of the housing, and the pull tab is configured to remove the sealing portion from the open proximal end.

25. A fluid path element having an inner lumen and an outer cylindrical wall surrounding the inner lumen, A disinfection cap configured to connect to the fluid path element, wherein the disinfection cap is A housing configured to receive the inner lumen and outer cylindrical wall of the fluid path element, wherein the housing comprises an open proximal end, a closed distal end, and a side wall extending between the open proximal end and the closed distal end to define the internal volume. A sleeve protruding proximally from the inner surface of the closed distal end, the sleeve defining an opening configured to receive the inner lumen of the fluid path element, A compressible absorbent material at least partially saturated with a disinfectant fluid, wherein the compressible absorbent material is placed within the internal volume of the housing and surrounds at least a portion of the outer part of the sleeve, A disinfection cap equipped with, Equipped with, The outer cylindrical wall of the fluid path element is configured to receive the disinfection space such that the movement of the fluid path element toward the closed distal end compresses the compressible absorbent material and releases at least a portion of the disinfectant fluid into the disinfection space between the inner surface of the housing and the sleeve. Fluid path assembly.

26. The fluid path assembly according to claim 25, wherein the inner surface of the sleeve is configured to engage in a sealing manner with the inner lumen of the fluid path element.

27. The fluid path assembly according to claim 25 or 26, wherein the compressible absorbent material extends from the closed distal end to the open proximal end of the housing.

28. The fluid path assembly according to any one of claims 25 to 27, wherein the sleeve comprises one or more ribs, the ribs protruding radially outward and configured to engage with the compressible absorbent material to prevent rotation of the compressible absorbent material relative to the sleeve.

29. The fluid path assembly according to any one of claims 25 to 28, wherein the compressible absorbent material has an axial slot configured to receive the outer cylindrical wall of the fluid path element.

30. The fluid path assembly according to any one of claims 25 to 29, wherein the sleeve comprises a tab configured to provide tactile or auditory feedback when the inner lumen of the fluid path element is fully inserted into the sleeve.

31. The fluid path assembly according to any one of claims 25 to 30, wherein the inner surface of the side wall is provided with one or more radially inwardly projecting projections, the projections being configured to removably engage with the fluid path element and to hold the disinfection cap on the fluid path element.

32. The fluid path assembly according to any one of claims 25 to 31, further comprising a gripping flange projecting distally from the closed distal end.

33. The fluid path assembly according to any one of claims 25 to 32, further comprising a sealing portion removably connected to the open proximal end, wherein the sealing portion fluidly seals the open proximal end.

34. The aforementioned fluid path element is A first connector element comprising a main body, a first lumen, a first flexible leg, and a second flexible leg, A second connector element comprising a body defining an undercut, a second lumen, a channel defined within the body, and at least one sealing element disposed within the channel, Equipped with, The first flexible leg portion comprises a first flange, and the second flexible leg portion comprises a second flange. When the first connector element engages with the second connector element, the first flange and the second flange engage with the undercut of the body of the second connector element in order to prevent the first connector element and the second connector element from disengaging. The sealing element is configured to define a fluid seal between the second lumen of the second connector element and the first lumen of the first connector element in order to form a fluid path when the first connector element and the second connector element engage with each other. A fluid path assembly according to any one of claims 25 to 33.

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