Sterilizing cap for fluid path element

Abstract

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

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to 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 incorporated herein by reference in their entireties. Technical Field

[0003] The present disclosure generally relates to features associated with multi-patient fluid path elements of a powered medical fluid injection system, and more particularly to caps for fluid path elements that prevent contamination with microbial contaminants prior to and between consecutive fluid injection procedures utilizing a universal multi-patent fluid path kit. Background Art

[0004] A syringe injection system is a medical device used in medical imaging procedures. To reduce the number of disposable components during a series of fluid injections, the system can combine a multi-patient portion, such as a multi-patient pump system and a multi-patient fluid path element, which can be used in a series of fluid injection procedures; and a single-patient fluid path element, including an associated check valve, which is only used for a single injection procedure and then discarded and replaced by a new sterile single-patient fluid path element for a subsequent fluid injection procedure.

[0005] Many syringe-based or peristaltic pump-based powered injectors have been developed for use in medical procedures such as cardiovascular angiography (CV), computed tomography (CT), and nuclear magnetic resonance (NMR) / magnetic resonance imaging (MRI). Some of these powered injectors may include the option of being used in a multi-patient configuration utilizing both multi-patient and single-patient units. An example of such a system is the Bayer Centargo CT fluid injection system, including multi-patient and single-patient components described in U.S. Patent Nos. 10,507,319 and 10,549,084, respectively, the disclosures of which are incorporated herein by reference. Another example of such a system is the Bayer Fluid injection system.

[0006] Because various multi-patient components are used in multiple fluid injection procedures, measures must be taken or component designs must include features to ensure that these components are not exposed to or are sterilized to remove microbial contaminants that could be harmful to subsequent patients prior to the next injection procedure. For example, many systems may include a swabable valve that can be sterilized by a technician wiping the valve with an alcohol-soaked wipe between injection procedures.

[0007] Conventional systems with replaceable valves include a standard Luer-type connector between the multi-patient and single-patient components, which is equipped with a readily replaceable valve on the female Luer component and may include a threaded connection mechanism. An example of a threaded connector for a multi-patient configuration is described in U.S. Patent No. 8,540,698, the disclosure of which is incorporated herein by reference. When performing multiple fluid injection procedures at high throughput, connecting and disconnecting the threaded connector and manually wiping the replaceable valve is time-consuming and may reduce the efficiency of the injection kit. In addition, such threaded connections may be easily over-tightened or under-tightened, resulting in potential leaks or connection defects.

[0008] When replacing used single-patient fluid path components between infusion procedures, active disinfection may be more desirable to ensure that surfaces of multi-patient fluid path components are not contaminated. A new system for actively disinfecting multi-patient fluid path components in an efficient and effective manner, including a simple connection method, is needed. Summary of the invention

[0009] The present disclosure provides a sterile fluid component cap for ensuring a sterile connection between two fluid path components injected with a power fluid during contrast enhanced imaging procedures such as computed tomography (CT), angiography (CV), and magnetic resonance imaging (MRI) imaging procedures.

[0010] In certain embodiments, a sterilization cap for a fluid path element is provided. The sterilization cap may include a housing configured to be assembled on at least a portion of 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 to define an internal volume. The sterilization cap may also include a compressible absorbent material at least partially soaked with disinfectant, and the compressible absorbent material is located in the internal volume of the housing. The sterilization cap may also include an insert located in the internal volume, which is connected to the compressible absorbent material, and the insert may move toward the closed distal end to compress the compressible absorbent material as the fluid path element moves toward the closed distal end. The insert may include a fluid path sealing portion and a circumferential flange extending around the fluid path sealing portion, the fluid path sealing portion being configured to seal the cavity on the fluid path element, the circumferential flange comprising one or more passages, and the one or more passages being configured to allow disinfectant to flow from the compressible absorbent material to the fluid path element when the insert is pushed toward the closed distal end by the fluid path element.

[0011] In some embodiments, the inner surface of the sidewall may include one or more radially inwardly projecting protrusions, the one or more radially inwardly projecting protrusions being configured to removably engage the fluid path element and retain the disinfection cap on the fluid path element. Movement of the insert toward the closed distal end by movement of the fluid path element may compress the compressible absorbent material and release at least a portion of the disinfectant fluid through the one or more passages so that the disinfectant 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 side wall of the housing. The fluid path sealing portion may include a rubber material, a flexible plastic material, or a silicone material configured to form a fluid tight seal with the cavity of the fluid path element. The absorbent material may be a sponge or cotton. The disinfectant may include isopropyl alcohol, ethanol, a combination thereof, or an aqueous solution thereof.

[0013] In some embodiments, the gripping flange may protrude distally from the closed distal end. The seal may be removably connected to the open proximal end, wherein the seal fluid seals the open proximal end. The seal may include a pull tab protruding radially outward relative to the side wall of the housing. The pull tab may be configured to remove the seal from the open proximal end.

[0014] In some embodiments, a second compressible absorbent material may be disposed on a proximal surface of the insert and around 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 to compress the compressible absorbent material and release at least a portion of the disinfectant solution.

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

[0016] In certain embodiments, the disinfection cap for fluid path element may include a housing, the housing being configured to be assembled on at least a portion of the fluid path element, the housing including 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 also include a flange extending through the inside of the housing between the open proximal end and the open distal end, the flange including one or more openings. The disinfection cap may also include a compressible absorbent material at least partially soaked with disinfectant, wherein the compressible absorbent material may be located at the distal end of the flange. The disinfection cap may also include a plunger connected to the housing to close the open distal end, the plunger may slide between the open distal end and the open proximal end relative to the housing. The movement of the plunger in the proximal direction may compress the compressible absorbent material and release at least a portion of the disinfectant by one or more openings.

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

[0018] In some embodiments, the plunger may include a collapsible fluid ball containing a disinfectant liquid, wherein the collapsible fluid ball can be collapsed by a pushing movement in a proximal direction to dispense the disinfectant liquid into the housing through one or more holes in the proximal end of the plunger. The inner surface of the sidewall may include one or more radially inwardly projecting protrusions, the one or more radially inwardly projecting protrusions being configured to removably engage the fluid path element and retain the disinfection cap on the fluid path element.

[0019] In some embodiments, a disinfection cap for a fluid path element, the fluid path element has an inner cavity and an outer cylindrical wall around the inner cavity, and the disinfection cap may include a housing, the housing being configured to receive the inner cavity and the outer cylindrical wall of 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 to define an internal volume. The disinfection cap may also include a sleeve protruding proximally from the inner surface of the closed distal end, the sleeve defining an opening, and the opening being configured to receive the inner cavity of the fluid path element. The disinfection cap may also include a compressible absorbent material at least partially impregnated with disinfectant, the compressible absorbent material being arranged in the inner volume of the housing, and surrounding at least a portion of the outside of the sleeve. The outer cylindrical wall of the fluid path element may be configured to be received in the disinfection space between the inner surface of the housing and the sleeve, so 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 into the disinfection space.

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

[0021] In some embodiments, the sleeve may include one or more radially outwardly projecting longitudinal ribs configured to engage the compressible absorbent material around the exterior of the sleeve to prevent the compressible absorbent material from rotating relative to the sleeve. The compressible absorbent material may have an axial groove 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 lumen of the fluid path element is fully inserted into the sleeve.

[0022] In some embodiments, a fluid path assembly is provided, which may include a fluid path element having an inner cavity and an outer cylindrical wall surrounding the inner cavity; and a disinfection cap configured to be connected to the fluid path element. The disinfection cap may include a housing, the housing being configured to receive the inner cavity and the outer cylindrical wall of the fluid path element, the housing comprising an open proximal end, a closed distal end, and a sidewall extending between the open proximal end and the closed distal end to define an internal volume. The disinfection cap may also include a sleeve protruding proximally from the inner surface of the closed distal end, the sleeve defining an opening, and the opening being configured to receive the inner cavity of the fluid path element. The disinfection cap may also include a compressible absorbent material at least partially impregnated with disinfectant, the compressible absorbent material being disposed in the inner volume of the housing and surrounding at least a portion of the outside of the sleeve. The outer cylindrical wall of the fluid path element may be configured to be received in the disinfection space between the inner surface of the housing and the sleeve, so 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 into the disinfection space.

[0023] In some embodiments, the fluid path element can be a Luer connector, a multi-patient fluid path element, or a single-patient fluid path element. In some embodiments, the fluid path element can include a first connector element having a body, a first cavity, a first flexible leg, and a second flexible leg. The fluid path element may also include a second connector element having a body defining an undercut, a second cavity, a channel defined in the body, and at least one sealing element positioned in the channel. The first flexible leg may include a first flange, and the second flexible leg includes a second flange. When the first connector element engages with the second connector element, the first flange and the second flange may engage with the undercut of the body of the second connector element to prevent the first connector element and the second connector element from disengaging. The sealing element may be configured to define a fluid-tight seal between the second cavity of the second connector element and the first cavity of the first connector element to form a fluid path when the first connector element and the second connector element engage with each other.

[0024] In addition to the illustrative aspects and features described above, further aspects and features will become apparent by reference to the drawings and the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The features of the various embodiments of the sterilization cap described herein are set forth with particularity in the appended claims. However, these features, both as to organization and method of operation, may be better understood by reference to the following description taken in conjunction with the accompanying drawings.

[0026] Figure 1A is a perspective view of a fluid path kit for use with a fluid injector according to one embodiment of the present disclosure;

[0027] Figure 1B is a perspective view of a fluid path element of a fluid path kit configured to be connected to a sterile cap as described herein having various embodiments of the present disclosure;

[0028] Figure 2A is a perspective view of a sterilization cap for use with a fluid path element of a fluid path kit according to one embodiment of the present disclosure;

[0029] Figure 2B for Figure 2A a side cross-sectional view of the disinfection cap shown;

[0030] Figure 2C for Figure 2A a perspective cross-sectional view of the sterilization cap shown;

[0031] Figure 2D for Figure 2A a perspective cross-sectional view of the sterilization cap shown, wherein the fluid path element is shown connected to the sterilization cap in a first position;

[0032] Figure 2E for Figure 2A a perspective cross-sectional view of the sterilization cap shown, wherein the fluid path element is shown connected to the sterilization cap in a second position;

[0033] Figure 2F for Figure 2B a perspective view of an insert of the sterilization cap shown;

[0034] Figure 3A is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0035] Figure 3B for Figure 3A a perspective cross-sectional view of the sterilization cap shown with a fluid path element connected to the sterilization cap;

[0036] Figure 3C for Figure 3A a front perspective view of an insert of the illustrated sterilization cap;

[0037] Figure 3D for Figure 3Aa rear perspective view of the insert of the illustrated disinfection cap;

[0038] Figure 4A is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0039] Figure 4B for Figure 4A a perspective cross-sectional view of the sterilization cap shown with a fluid path element connected to the sterilization cap;

[0040] Figure 4C for Figure 4A a rear perspective view of the compressible absorbent material on the insert of the illustrated disinfection cap;

[0041] Figure 5A is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0042] Figure 5B for Figure 5A a perspective cross-sectional view of the sterilization cap shown with a fluid path element connected to the sterilization cap;

[0043] Figure 5C for Figure 5A a front perspective view of the compressible absorbent material of the illustrated sterilization cap;

[0044] Fig. 6A is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0045] Figure 6B for Fig. 6A a side cross-sectional view of the sterilization cap shown with a fluid path element coupled to the sterilization cap;

[0046] Figure 6C for Fig. 6A A top view of the sliding member of the disinfection cap shown;

[0047] Fig.6D for Fig. 6A A side perspective view of a sliding member of the disinfection cap shown;

[0048] Fig. 7A is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0049] Figure 7B for Fig. 7A a perspective cross-sectional view of the sterilization cap shown with a fluid path element connected to the sterilization cap;

[0050] Fig. 8Ais a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0051] Figure 8B for Fig. 8A a perspective cross-sectional view of the sterilization cap shown with a fluid path element connected to the sterilization cap;

[0052] Fig. 9A is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0053] Fig. 9B for Fig. 9A A side cross-sectional view of the sterilization cap shown, wherein the sealing member is in an open state;

[0054] Fig. 10A is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0055] Fig. 10B For Fig. 10A A perspective view of a sleeve portion of a compressible absorbent material for use with the sterilization cap shown;

[0056] Fig.11A is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure, wherein the sterilization cap is in an off position;

[0057] Fig. 11B for Fig.11A a side cross-sectional view of the sterilization cap shown with the sterilization cap in an attached position;

[0058] Fig. 12A is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure, wherein the sterilization cap is in an off position;

[0059] Fig. 12B for Fig. 12A a side cross-sectional view of the sterilization cap shown with the sterilization cap in an attached position;

[0060] Fig.13A is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0061] Fig. 13B for Fig.13A a side cross-sectional view of the sterilization cap in combination with the fluid path element in a first position;

[0062] Fig. 13C for Fig.13A a side cross-sectional view of the sterilization cap in combination with the fluid path element in a first position;

[0063] Fig.14A is a perspective view of an outer shell of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0064] Fig. 14B is a perspective view of an inner sealing member of a sterilization cap;

[0065] Fig. 14C is a side cross-sectional view of an assembled sterilization cap with a fluid path element coupled to the sterilization cap and an inner sealing member shown in a first position;

[0066] Fig.14D is a side cross-sectional view of an assembled sterilization cap with a fluid path element coupled to the sterilization cap and an inner sealing member shown in a second position;

[0067] Fig.15A is a perspective cross-sectional view of a sterilization cap for use with and connected to a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0068] Fig. 15B for Fig.15A a perspective exploded view of the sterilization cap and fluid path components shown;

[0069] Fig. 15C for Fig.15A A perspective view of the outer shell of the disinfection cap shown;

[0070] Fig.15D for Fig.15A a rear perspective view of the compressible absorbent material of the illustrated sterilization cap;

[0071] Fig.15E for Fig.15A A perspective view of an insertable tray of the sterilization cap shown;

[0072] Fig.16A is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0073] Fig. 16B for Fig.16A a side cross-sectional view of the sterilization cap shown with a fluid path element coupled to the sterilization cap;

[0074] Fig.17A is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0075] Fig. 17B for Fig.17A a side cross-sectional view of the sterilization cap shown with a fluid path element coupled to the sterilization cap;

[0076] Fig. 17C for Fig.17A a perspective cross-sectional view of the cylindrical fluid volume feature of the sterilization cap shown;

[0077] Fig.18A is a perspective cross-sectional view of a sterilization cap engaged with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0078] Fig.18B for Fig.18A a side cross-sectional view of the sterilization cap shown without a fluid path element connected to the sterilization cap;

[0079] Fig.19A is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0080] Fig.19B for Fig.19A a perspective cross-sectional view of the sterilization cap shown without the compressible absorbent material;

[0081] Fig. 20A is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0082] Fig. 20B for Fig. 20A a perspective cross-sectional view of the sterilization cap shown without the compressible absorbent material;

[0083] Fig. 20C for Fig. 20A a perspective cross-sectional view of the sterilization cap shown, wherein the fluid path element is shown connected to the sterilization cap in a first position;

[0084] Fig.20D for Fig. 20A a perspective cross-sectional view of the sterilization cap shown, wherein the fluid path element is shown connected to the sterilization cap in a second position;

[0085] Fig.21 is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0086] Fig.22A is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0087] Fig. 22B for Fig.22Aa perspective cross-sectional view of the sterilization cap shown without the compressible absorbent material;

[0088] Fig.23A is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0089] Fig. 23B For Fig.23A A perspective view of a compressible absorbent material for use with the sterilization cap shown;

[0090] Fig.23C is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0091] Fig.23D For Fig.23C A perspective view of a sealing insert and a compressible absorbent material used with the sterilization cap shown;

[0092] Fig.24A is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0093] Fig. 24B for Fig.24A a perspective view of the compressible absorbent material of the sterilization cap shown;

[0094] Fig.24C for Fig.24A a side cross-sectional view of the sterilization cap shown with a fluid path element coupled to the sterilization cap;

[0095] Figures 24D-24E for Fig.24A A perspective cross-sectional view of an alternative configuration of the sterilization cap shown;

[0096] Fig.24F for Fig.24D A front view of the disinfection cap shown;

[0097] Fig.25 is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0098] Fig.26A is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0099] Fig.26B for Fig.26A a perspective cross-sectional view of the sterilization cap shown without the compressible absorbent material;

[0100] Fig.27Ais a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0101] Fig.27B for Fig.27A a perspective cross-sectional view of an alternate configuration of the sterilization cap shown, wherein the fluid path element is shown connected to the sterilization cap in a first position;

[0102] Fig.27C for Fig.27B a perspective cross-sectional view of the sterilization cap shown with the fluid path element shown connected to the sterilization cap in a second position;

[0103] Fig.28A is a perspective view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0104] Fig.28B for Fig.28A a side perspective view of the sterilization cap shown;

[0105] Fig.28C for Fig.28A a side cross-sectional view of the disinfection cap shown;

[0106] Fig.29 is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0107] Fig. 30A is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0108] Fig. 30B For Fig. 30A A perspective view of an elastic reservoir for use with the sterilization cap shown;

[0109] Fig.31A is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0110] Fig.31B for Fig.31A a perspective cross-sectional view of the sterilization cap shown without the compressible absorbent material;

[0111] Fig.32A is a perspective cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0112] Fig.32B for Fig.32A Exploded side cross-sectional view of the sterilization cap shown.

[0113] Fig.33A is a side cross-sectional view of a sterilization cap for use with a fluid path element of a fluid path kit according to another embodiment of the present disclosure;

[0114] Fig.33B for Fig.33A A perspective cross-sectional view of an alternative configuration of the sterilization cap shown;

[0115] Fig.34A is a perspective view of a strip having multiple sterilization caps according to another embodiment of the present disclosure; and

[0116] Fig.34B For receiving Fig.34A A perspective view of a package of multiple strips of sterilization caps is shown.

[0117] In Figures 1 to Fig.34B In the drawings, unless otherwise specified, like characters designate the same parts and elements as appropriate. DETAILED DESCRIPTION

[0118] The following description is provided to enable those skilled in the art to make and use the aspects contemplated for carrying out the present disclosure. However, various modifications, equivalents, variations and alternatives will still be apparent to those skilled in the art. Any and all such modifications, variations, equivalents and alternatives are intended to fall within the spirit and scope of the present disclosure.

[0119] 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, those skilled in the art may translate from the plural to the singular and / or from the singular to the plural, as appropriate, depending on the context and / or application. For the sake of clarity, the various singular / plural arrangements are not explicitly set forth herein.

[0120] Spatial or directional terms, such as "left", "right", "inner", "outer", "upper", "lower", etc., relate to the embodiments or aspects shown in the drawings and should not be considered limiting as the embodiments or aspects may assume various alternative orientations.

[0121] All numbers used in the specification and claims should be understood as being modified by the term "about" in all cases. "About" means plus or minus 25% of the stated value, for example, plus or minus 10% of the stated value. However, this should not be considered as a limitation on any numerical analysis under the doctrine of equivalents.

[0122] Unless otherwise stated, all ranges or ratios disclosed herein should be understood to include starting and ending values ​​and any and all subranges or subratios contained therein. For example, a specified range or ratio of "1 to 10" should be considered to include any and all subranges or subratios between a minimum value of 1 and a maximum value of 10 (including the end values); that is, all subranges or subratios start with a minimum value of 1 or greater and end with a maximum value of 10 or less. The ranges and / or ratios disclosed herein represent average values ​​of specific ranges and / or ratios.

[0123] The term “comprising” is synonymous with “including.” The terms “first,” “second,” etc. are not intended to refer to any particular order or sequence, but rather to different conditions, attributes, or elements.

[0124] All documents mentioned herein are "incorporated by reference" in their entirety.

[0125] 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 conjunction with a threshold value. As used herein, satisfying a threshold value may refer to a value greater than a threshold value, above a threshold value, greater than or equal to a threshold value, less than a threshold value, below a threshold value, less than or equal to a threshold value, equal to a threshold value, etc.

[0126] In some cases, one or more components may be referred to herein as "configured," "operable," "adapted," etc. Those skilled in the art will recognize that "configured to" may generally encompass active state components and / or inactive state components and / or standby state components, unless the context requires otherwise.

[0127] "Coupled" and "connected" and their derivatives may be used to describe certain aspects. It should be understood that these terms are not intended to be synonymous with 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.

[0128] The subject matter described herein sometimes illustrates that different components are contained in different other components, or are connected to different other components. It should be understood that the architecture described in this way is merely exemplary, and in fact many other architectures can be implemented to achieve the same function. Conceptually, any arrangement of components that implement the same function is effectively "associated" to achieve the desired function. Therefore, any two components combined here to achieve a specific function can be regarded as "associated" with each other to achieve the desired function, regardless of the architecture or intermediate components. Any two components so associated can also be regarded as "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 regarded as "operably coupled" to each other to achieve the desired function. Specific examples of operable coupling include, but are not limited to, physically matchable and / or physically interacting components.

[0129] Furthermore, even if specific numbers of an introduced claim recitation are explicitly recited, those skilled in the art will recognize that such recitations should generally be interpreted to mean at least the number recited (e.g., a simple recitation of "two recitations" without other modifiers generally means at least two recitations, or two or more recitations). Furthermore, in those cases where the convention is similar to "at least one of A, B, and C, etc.", generally, such construction is intended to allow those skilled in the art to understand the convention (e.g., "a system having at least one of A, B, and C" would include but is not limited to systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In those cases where the convention is similar to "at least one of A, B, or C, etc.", generally, such construction is intended to allow those skilled in the art to understand the convention (e.g., "a system having at least one of A, B, or C" would include but is not limited to systems having A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will further understand that disjunctive words and / or phrases that generally represent two or more optional terms, whether in the specification, claims or drawings, should be understood to include the possibility of one term, one term or both terms, unless the context dictates otherwise. For example, the phrase "A or B" will be understood to include the possibility of "A" or "B" or "A and B".

[0130] When used relative 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 the component closest to the patient. When used relative to a component of an injector system, such as a fluid reservoir, syringe, connector, disinfectant cap, or fluid line, the term "proximal" refers to the portion of the component closest to the injector of the injector system (i.e., the portion of the component farthest from the patient). When used relative to a component of a fluid delivery system (such as a fluid reservoir, syringe, connector, disinfectant cap, or fluid line), the term "upstream" refers to the direction away from the patient and toward the injector relative to the normal fluid flow of the injector system. When used relative to a component of a fluid delivery system (such as a fluid reservoir, syringe, connector, disinfectant cap, or fluid line), the term "downstream" refers to the direction toward the patient and away from the injector relative to the normal fluid flow of the fluid delivery system.

[0131] The term "radial" and related terms generally refer to the direction perpendicular to the longitudinal axis of the syringe, connector, dust cap or other components of the injector system. However, it should be understood that the present disclosure may adopt various alternative variations and step sequences unless otherwise expressly provided. It should also be understood that the specific equipment and processes shown in the drawings and described in the following specification are merely exemplary aspects of the present disclosure. Therefore, specific dimensions and other physical characteristics related to the aspects disclosed herein should not be considered limiting.

[0132] It should be noted that any reference to "an embodiment," "one aspect," or "aspects" means that a particular feature, structure, or characteristic described in conjunction with the embodiment or aspect is included in at least one embodiment or aspect. Thus, the phrases "in one embodiment," "in one aspect," or "in aspects" appearing in various places throughout the specification are not necessarily all referring to the same aspect or embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments or aspects.

[0133] Those skilled in the art will recognize that, for the sake of conceptual clarity, the components (e.g., operations), devices, objects, and the accompanying discussions thereof described herein are intended to be examples only, and various configuration modifications are contemplated. Therefore, as used herein, the specific examples and accompanying discussions set forth are intended to be representative of their more general categories. In general, the use of any particular example is intended to be representative of its category, and the exclusion of a particular component (e.g., operation), device, and object should not be considered limiting.

[0134] Before explaining in detail the various aspects of the disinfection cap and its various features, it should be noted that the application or use of the various aspects disclosed herein is not limited to the details of the structure and arrangement of the components shown in the drawings and the specification. On the contrary, the disclosed device can be positioned or incorporated into other devices, its variations and modifications, and can be practiced or executed in various ways. Therefore, the aspects and features of the disinfection cap disclosed herein are illustrative in nature and are not meant to limit their scope or application. In addition, unless otherwise stated, the terms and expressions adopted herein are selected to describe the various aspects and features of the syringe for the convenience of the reader and do not limit their scope. In addition, it should be understood that any one or more components and features of the disinfection cap, its expression and / or its examples can be combined with any one or more other components, its expression and / or its examples without limitation.

[0135] The present disclosure relates to a design of a sterilization cap for use with a fluid path element 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 medium or contrast agent that highlights certain features in a medical image. This process is known as contrast enhanced medical imaging and typically includes the injection of a contrast medium (e.g., saline) with a suitable flushing agent prior to the imaging process. Powered fluid injectors have been used to control the injection of fluids and are typically designed with one or more (typically two) syringes for containing and dispensing contrast media, flushing fluids, and other medical fluids prior to or during the imaging process. For example, U.S. Patent No. 5,383,858 discloses a front-loading syringe and powered injector in a pressure sheath and a sheathless example, and the disclosure is incorporated herein by reference. Common contrast enhanced medical imaging procedures include computed tomography (CT), magnetic resonance imaging (MR), positron emission tomography (PET, SPECT), and angiography (CV). Due to viscosity and the need to deliver large amounts of contrast media in a short period of time, in order to provide a "tight bolus injection", certain injection procedures may be performed at high injection pressures, such as injection pressures of up to 300 psi for CT and MR and up to 1200 psi for CV procedures. The injector can be configured to inject or dispense the fluid medium contained in the first, second and / or additional syringes in a controlled manner, for example, as can be used 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 disclose front-loading injectors and power injectors in pressure sheathed and sheathless examples, and these disclosures are incorporated herein by reference.

[0136] The fluid injection system may include a configuration for multi-patient injections, wherein a portion of the disposable elements of the fluid path kit, such as the pumping mechanism (syringe, components of the peristaltic pump system, etc.) and the upstream components of the fluid path kit are used in a series of injection procedures before disposal (multi-patient elements); and another portion of the disposable elements of the fluid path kit (single-patient elements) are used once for a single patient and then discarded. For example, in U.S. Patents Nos. 10,507,319 and 10,549,084 and International PCT Publications Nos. WO 2021 / 173743; No. WO 2022 / 119837; and No. WO 2022 / 182935, the disclosures of which are incorporated herein by reference. Upon completion of the fluid injection procedure, the single-patient element is separated from the multi-patient element of the fluid path and discarded, and a new, sterile single-patient element is attached for the next injection procedure. This arrangement can reduce the cost of each fluid injection procedure and reduce the amount of medical waste generated by the injection kit. Between injection procedures, care must be taken to ensure that the distal connection(s) of the multi-patient element are not contaminated with microorganisms and are sterile when a new single-patient element is attached. The sterility of the single-patient element is ensured by storage and removal from associated sterile packaging immediately prior to connection with the multi-patient element. The present disclosure provides components that can be used with the multi-patient element to ensure that the connection features of the multi-patient element are sterile when connected with the single-patient element in preparation for a subsequent injection procedure.

[0137] refer to Figure 1A , shows an exemplary fluid path kit 100 according to some embodiments. The fluid path kit 100 may include at least one fluid reservoir 102, such as a syringe or peristaltic pump mechanism (not shown), which may be connected to a fluid injector for delivering fluid from the fluid reservoir 102 to a multi-patient fluid path kit 104, and / or for filling the fluid reservoir 102 with fluid from a bulk fluid source. The multi-patient fluid path kit 104 includes a fluid path element 106 for connecting to the fluid reservoir 102 at one end and a single-patient fluid path kit 108 at the opposite end. The single-patient fluid path kit 108 is configured to be disconnected from the multi-patient fluid path kit 104 and discarded after each use; and a new, sterile single-patient fluid path kit 108 is configured to be attached to the fluid path element of the multi-patient fluid path kit 104 for the next injection procedure. After a predetermined amount of time and / or a predetermined number of fluid delivery procedures, the multi-patient fluid path kit 104 is configured to be discarded.

[0138] refer to Figure 1B , the fluid path element 106 (e.g., Figure 1B102 and 106. The present invention relates to a method for treating a patient's fluid path element 106 in a manner that is suitable for treating a patient's fluid path element 106. The method of treating a patient's fluid path element 106 in a manner that is suitable for treating a patient's fluid path element 106 is shown in Figure 102. The method of treating a patient's fluid path element 106 in a manner that is suitable for treating a patient's fluid path element 106 is shown in Figure 102. The method of treating a patient's fluid path element 106 in a manner that is suitable for treating a patient's fluid path element 106 is shown in Figure 102. The method of treating a patient's fluid path element 106 in a manner that is suitable for treating a patient's fluid path element 106 is shown in Figure 106. The method of treating a patient's fluid path element 106 in a manner that is suitable for treating a patient's fluid path element 106 is shown in Figure 106. The method of treating a patient's fluid path element 106 in a manner that is suitable for treating a patient's fluid path element 106 is shown in Figure 106. The method of treating a patient's fluid path element 106 in a manner that is suitable for treating a patient's fluid path element 106 is shown in Figure 106. The method of treating a patient's fluid path element 106 in a manner that is suitable for treating a patient's fluid path element 106 In certain embodiments of the present disclosure, the body 110 may not have apertures defined on the outer skirt 116. Additional details of the construction 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.

[0139] Without being limited by any particular theory, it is believed that microbial contamination (if it occurs) will mainly occur on the outer "contactable" surfaces of the fluid path element 106 components and the outer surface of the cavity 112, rather than the inner surface of the cavity 112. Due to the shielding effect of the outer cover 116 surrounding the cavity 112 and extending beyond the end face of the cavity 112, contact contamination on the surface of the inner surface of the cavity 112 is unlikely. However, with the extension of exposure time, environmental contamination is also possible, such as through interaction with air pollutants or microbial migration. The surface outside the fluid path defined by the cavity 112 is unlikely to promote the transfer of microbial contaminants to the cavity 112 during connection or disconnection. By using the disinfection cap 200 described herein to disinfect these surfaces (such as the outer surface of the cavity 112 and the inner surface of the wall of the fluid path element 106), microbial contaminants can be prevented from being transferred to the inner cavity 112 and its fluid contact surfaces.

[0140] The present disclosure provides embodiments of a disinfection cap 200 that is configured to be removably attached to the fluid path elements 106 of a multi-patient fluid path kit 104 during transport and / or after removal of a single-patient fluid path kit 108. The disinfection cap 200 can perform a variety of functions, including, but not limited to: i) covering the fluid path elements 106 of the multi-patient fluid path kit 104 to prevent inadvertent contamination, such as through contact of the fluid path elements 106 of the multi-patient fluid path kit 104 with contaminated surfaces (e.g., surfaces in the injection kit or accidental contact with the hands of a technician); and i) disinfecting portions of the fluid path elements 106 of the multi-patient fluid path kit 104 by contact with a disinfecting, antiseptic, and / or sterilizing fluid (e.g., isopropyl alcohol solution, ethanol solution, mixtures thereof, aqueous solution, etc.), which is stored within or added to the disinfection cap 200 before removal of the disinfection cap 200 and connection with the single-patient fluid path kit 108. Ethanol solutions can be used because they have been shown to be effective antimicrobial agents and are compatible in the human bloodstream, reducing the need to seal the lumen of the fluid path to prevent contact with the disinfectant. Isopropyl alcohol is known to have bactericidal, antituberculotic, fungicidal, and virucidal effects. In certain embodiments, one or more sensors can be incorporated into the fluid injector to monitor the contact time of the fluid path components with the disinfection cap 200 to ensure that complete disinfection is achieved.

[0141] The disinfection cap 200 can be configured as a standard connection feature, such as a Luer-type connector, or can be designed to interact with a non-standard connection feature, such as, but not limited to, the connectors described in International PCT Application Publications No. WO 2021 / 168076, No. WO 2016 / 112163, No. WO2015 / 106107, and No. WO 2006 / 060688; or, for example, a non-standard syringe nozzle described in No. WO 2019 / 055497, the disclosure of which is incorporated herein by reference.

[0142] According to various embodiments, the disinfection cap 200 of the present disclosure may include an absorbent material (e.g., a polymer sponge, a cotton material, etc.) located inside the disinfection cap 200, wherein the absorbent material is at least partially saturated with disinfectant. When the disinfection cap 200 is attached to the fluid path element 106 of the multi-patient fluid path kit 104 and the user presses the activation surface, the disinfection cap and the absorbent material are pressed against the multi-patient fluid path element 106, compressing the absorbent material, and causing the disinfectant to contact at least a portion of one or more surfaces of the multi-patient fluid path element 106, thereby disinfecting one or more surfaces. In certain embodiments, at least a portion of the sponge may include an open-cell matrix to releasably capture the disinfectant. In various embodiments, at least a portion of the sponge may include a closed-cell matrix that does not absorb the disinfectant. For example, the closed-cell portion may be incorporated into the portion of the sponge that contacts the edge of the cavity 112 to prevent the disinfectant from being released into the interior of the cavity 112, while the portion of the sponge that does not contact the region adjacent to the cavity may include an open-cell matrix to release the disinfectant to the surface of the outside of the cavity when compressed.

[0143] In certain embodiments, the disinfection cap 200 may include a fluid path sealing portion or protrusion that sealingly engages the cavity 112 of the multi-patient fluid path kit 106 to prevent disinfection fluid from entering the cavity 112 and / or to prevent any fluid from dripping from the interior of the cavity 112. By preventing disinfection fluid from entering the cavity 112, contamination of the cavity and any medical fluid therein is avoided, for example, by preventing any microbial contaminants from being flushed into the cavity 112 when the disinfection fluid flows through the passageway and contacts at least a portion of one or more surfaces of the multi-patient fluid path kit 104. For example, the sealing portion or protrusion may include a sealable material (e.g., silicone, a polymeric material, a closed-cell foam, etc.) that engages with the edge of the cavity and seals and prevents disinfection fluid from entering the cavity 112.

[0144] refer to Figure 2A-2C , shows a disinfection cap 200 according to one embodiment of the present disclosure. The disinfection cap 200 may include a housing 202 configured to be assembled on at least a portion of the fluid path element 106 (eg, Figure 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 sidewall 208 extending between the open proximal end 204 and the closed distal end 206 to form an interior volume 210 (eg, Figure 2B-2C106). In some embodiments, the housing 202 can have a shape corresponding to the shape of at least a portion of the fluid path element 106. For example, the housing 202 can be constructed and designed to fit over at least a portion of the fluid path element 106, such as the cavity 112 and the outer skirt 116. The exterior of the closed distal end 206 can include a gripping element 212, such as a tab, for manipulation by a user to allow the disinfection cap 200 to be easily attached to and removed from the fluid path element 106. The gripping element 212 can protrude distally from the closed distal end 206. In some embodiments, the gripping element 212 can be formed on an outer surface of the housing 202, such as the sidewall 208. For example, the gripping element 212 can be one or more protrusions that protrude radially outward from the outer surface of the housing 202.

[0145] refer to Figure 2B-2C , a compressible absorbent material 214 can be disposed within the interior volume 210 of the housing 202. In some embodiments, the compressible absorbent material 214 can be adjacent to or connected to the closed distal end 206. As described herein, the compressible absorbent material 214 can be at least partially impregnated with a disinfectant solution. In some embodiments, the compressible absorbent material 214 can have an annular shape with a central opening 216. In other embodiments, the compressible absorbent material 214 is made into a cylindrical shape to fill at least a portion of the interior volume 210. The compressible absorbent material 214 can be made of a sponge material (open cell and / or closed cell), a cotton material, other medical grade absorbent materials, etc.

[0146] Other embodiments of the disinfection cap 200 may provide a dry, sterile form to which a disinfection fluid may be added, such as from a body-phase disinfection fluid source, before or after the disinfection cap 200 is attached to the fluid path element 106. In this manner, problems associated with sealing the disinfection cap 200 with a fluid and the possibility of the fluid drying out may be avoided.

[0147] refer to Figure 2D-2E , when the disinfection cap 200 is in the first position ( Figure 2D ) is engaged with fluid path element 106 of multi-patient fluid path kit 104, and fluid path element 106 is pushed toward closed distal end 206, disinfection cap 200 and compressible absorbent material 214 are in the second position ( Figure 2E ) is pressed against the multi-patient fluid path element 106, thereby compressing the compressible absorbent material 214 and causing the disinfectant fluid to contact at least a portion of one or more surfaces of the multi-patient fluid path element 106, thereby disinfecting the one or more surfaces. Figure 2D and 2E A different sterilization cap 200 is shown, but the engagement mechanism in both sterilization caps 200 is the same.

[0148] refer to Figure 2B-2C, the disinfection cap 200 may include a slidable insert 218 that is adjacent to the compressible absorbent material 214 within the interior volume 210. For example, the slidable insert 218 may abut a proximal surface 220 of the compressible absorbent material 214. The slidable insert 218 may include a fluid path sealing surface 222 that is configured to mate with a distal surface 118 (e.g., a distal surface 118) of the cavity 112 of the fluid path element 106. Figure 1B As shown) Figure 2D-2E As shown, the fluid path sealing surface 222 is configured to seal the cavity 112 of the fluid path component 106, thereby preventing fluid communication and disinfectant fluid from entering the cavity 112, and preventing the medical fluid in the cavity 112 from flowing into the interior volume 210 of the disinfection cap 200. In some embodiments, the fluid path sealing surface 222 may include a rubber, a flexible plastic, a closed-cell sponge, or a silicone material configured to form a fluid-tight seal with the cavity 112 of the fluid path component 106.

[0149] refer to Figure 2C , the slidable insert 218 may further include a circumferential flange 224 extending radially around the fluid path sealing surface 222. The circumferential flange 224 may include one or more passages 226, such as slots or holes, extending through the slidable insert 218 to provide fluid communication therethrough. In some embodiments, the one or more passages 224 may be made of or coated with a flexible material that maintains the passages in a normally closed position (no fluid communication) and then is configured to deform and open under fluid pressure, such as when the fluid path element 106 is pushed toward the closed distal end 206, to allow fluid communication between the disinfectant fluid in the compressible absorbent material 214 and the fluid path element 106. Optionally, the passages 226 may include a covering material, such as by covering over the holes, or by adhesively attaching a film, that will at least partially release or rupture when the disinfectant fluid applies sufficient pressure.

[0150] When the slidable insert 218 is engaged with the distal end of the fluid path element 106, for example, by pressing the disinfection cap 200 against the fluid path element 106 or moving the disinfection cap 200 from an unactivated first position, in which the disinfection cap 200 only covers the distal end of the fluid path element 106, to an activated second position, in which the disinfection cap 200 is further pressed against 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. 2 ). Figure 2E ), which releases disinfectant from the compressible absorbent material 214 through one or more passageways 226 and into contact with the surface of the fluid path element 106, allowing disinfection of the contacted surface.

[0151] The at least partial compression of the compressible absorbent material 214 is configured to release the disinfectant liquid from the compressible absorbent material 214, and the disinfectant liquid flows through the 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 cavity 112 and the inner and outer surfaces of the outer skirt 116. The disinfectant liquid contacts the various surfaces of the fluid path element 106 and the sealing elements (e.g., O-rings, etc.) for an appropriate time, such as from a few seconds to 7 days, and can effectively disinfect any microbial contaminants on the contacted surfaces, such as germs, bacteria, viral particles, bodily fluids of previous patients, and other disease-causing pathogens. In some embodiments, the disinfection cap 200 and the corresponding compressible absorbent material 214 can be rotated about the longitudinal axis of the fluid path element 106 to generate a frictional effect to further assist in disinfecting the contacted surfaces. After disinfection cap 200 has been in sterile engagement with fluid path element 106 for a predetermined period of time, and when the technician is ready to begin the next injection procedure, disinfection cap 200 can be removed, such as by grasping grip element 212 and pulling disinfection cap 200 away from fluid path element 106, and a new single-patient fluid path set 108 (e.g., Figure 1A ) can be connected to the sterile distal end of the multi-patient fluid path element 106.

[0152] According to an alternative embodiment, disinfectant can be contained in disinfection cap 200, without compressible absorbent material 214, so that disinfectant can be kept sealingly by the circumferential flange of sliding insert 224. In such an embodiment, circumferential flange 224 can be sealingly connected to the inner surface 228 of sidewall 208. Pressing disinfection cap 200 against the distal end of fluid path element 106 will produce pressure on disinfectant, and pressure will overcome the seal between circumferential flange 224 and the inner surface 228 of sidewall 208 of disinfection cap 200. Then, disinfectant can flow through sliding insert 218 and contact fluid path element 106, as described herein. In addition, when insert 218 is pressed against the distal end surface of fluid path element 106, fluid path sealing surface 222 forms a fluid tight seal with cavity 112, preventing the fluid communication between the internal volume 210 of disinfection cap 200 and cavity 112.

[0153] refer to Figure 2B-2C , the inner surface 228 of the disinfection cap 200 may include one or more radially inwardly projecting protrusions 230 or retaining protrusions located at the proximal end 204. The one or more radially inwardly projecting protrusions 230 may be configured to removably engage with a corresponding engagement feature 120, such as a flange, a top surface, at least a portion of an edge (Lip) and / or at least a portion of a circumferential groove around the proximal end 111 of the fluid path element 106, or Figure 2D-2EThe one or more indentations on the surface of the outer skirt 116 of the fluid path element 106 are shown. The engagement of the one or more protrusions 230 with the corresponding engagement features 120 on the fluid path element 106 can releasably retain the disinfection cap 200 on the fluid path element 106 and prevent accidental removal of the disinfection cap 200, such as due to impact or gravity during storage or transportation.

[0154] The interaction between one or more radially inwardly protruding projections 230 on the disinfection cap 200 and the corresponding engagement features 230 on the fluid path element 106 can be configured to provide an audible and / or visual indicator to indicate to the technician that the disinfection cap 200 has been fixed to the fluid path element 106 and / or that the disinfection cap 200 has moved to the second activation state and the fluid path element 106 has been in contact with the disinfectant. Features for generating audible and / or visual indicators can be located on the disinfection cap 200, the fluid path element 106, or can be located on both, wherein, when the disinfection cap 200 is attached and / or moved to the second activation state, they are configured to interact. The audible and / or visual indicator can also include one or more colors, lines, permanent deformation, audible clicks or snaps, etc. To indicate to the technician that the disinfectant has been dispensed and the fluid path element 106 has been disinfected.

[0155] refer to Figure 2A , the disinfection cap 200 may further include a seal 232. In some embodiments, the seal 232 may extend through the open proximal end 204 to seal the interior volume 210 (eg, Figure 2B 204). The seal 232 can be an adhesive and / or frangible seal that is removably attached and covers the open proximal end 204 of the disinfection cap 200. The seal 232 allows for the transport and storage of the disinfection cap 200 without loss (e.g., evaporation) and / or contamination of the disinfection liquid in the interior volume 210 of the housing 202. The seal 232 can be a single seal, i.e., a seal that covers only a single disinfection cap 200, or can be a multi-cap seal, such as an extended rectangular or square surface with multiple sealing portions for storing and sealing multiple disinfection caps 200, as described herein with reference to Fig.34A The plurality of sterilization caps 230 may be removed from the multi-cap seal 232 one by one as needed without affecting the sterility or condition of the remaining sterilization caps 200 .

[0156] Disinfection cap 200 can be coupled to fluid path element 106 in a first inactive state in which the disinfectant does not contact the surface of fluid path element 106 and in a second active state in which the disinfectant contacts the surface of fluid path element 106. In some embodiments, disinfection cap 200 can be coupled to fluid path element 106 in a first inactive state in which the disinfectant does not contact the surface of fluid path element 106 and in a second active state in which the disinfectant contacts the surface of fluid path element 106. Figure 2B and 2C As shown) and / or by a rotational movement about the longitudinal axis L, the disinfection cap 200 can be switched from the inactive state to the active state.

[0157] In certain embodiments, the disinfection cap 200 may be configured to twist about the longitudinal axis L after the disinfection cap 200 and the compressible absorbent material 214 are pushed into engagement with the fluid path element 106 to provide a scrubbing action between the compressible absorbent material 214 and the various surfaces of the fluid path element 106, thereby further engaging the disinfectant fluid with the surfaces of the fluid path element 106 and providing enhanced disinfection. The twisting may be achieved by manually rotating the gripping element 212 during or after the disinfection cap 200 is engaged with the fluid path element 106.

[0158] After activation, disinfection cap 200 can remain engaged with fluid path element 106 in the activated state for a sufficient period of time to disinfect any microorganisms or pathogenic materials on all contact surfaces. Disinfection cap 200 can also serve as a dust cap to prevent contamination of distal end 113 of fluid path element 106 by dust particles that may be floating in the air of the injection kit. Disinfection cap 200 can remain in place until the next patient and injector are ready for the subsequent patient injection procedure, at which time they can be removed and the disinfected / sterilized distal end of multi-patient fluid path element 106 can be engaged with the proximal end of single-patient fluid path kit 108 (e.g., Figure 1A shown).

[0159] refer to Figures 3A-34B , shows a disinfection cap 200 according to an additional embodiment of the present disclosure. Figures 3A-34B The components of the disinfection cap 200 shown are similar to those described herein. Figures 2A-2F The components of the disinfection cap 200 described above are substantially similar or identical. Figures 3A-34B The reference numerals in the figure are used to indicate Figures 2A-2F The same parts as the corresponding reference numerals are shown in FIG. Figures 2A-2F The discussion of the sterilization cap 200 shown is applicable to Figures 3A-34B The sterilization caps 200 are shown, and therefore only the relative differences between the sterilization caps 200 are discussed below.

[0160] refer to Figure 3A-3B, the disinfection cap 200 may include a dual compressible absorbent material arrangement, with compressible absorbent material 214 on both sides of a sliding insert 218. Specifically, a first compressible absorbent material 214a is disposed on the distal side of the insert 218, and a second compressible absorbent material 214b is disposed on the proximal side of the insert 218. The first compressible absorbent material 214a is used to release disinfectant to 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 that is configured to receive the cavity 112 of the fluid path element 106 so that the cavity 112 can contact the fluid path sealing surface 222 of the sliding insert 218 to seal the cavity 112 from the interior volume 210 of the disinfection cap 200. As shown in FIG. Figure 3B As shown, the second compressible absorbent material 214b is configured to be received within the outer skirt 116 of the fluid path element 106. In this manner, rotation of the disinfection cap 200 relative to the fluid path element 106 about the longitudinal axis L will scrub the inner surface of the outer skirt 116 and the outer surface of the cavity 112 with the second compressible absorbent material 214b.

[0161] refer to Figure 3C-3D , insert 218 may have a threaded distal end 234, which may be threadedly engaged with the housing 202 of the disinfection cap 200. For example, the disinfection cap 200 may include an internal threaded portion, which is configured to engage the threaded distal end 234 of the slidable insert 218, so that when the disinfection cap 200 rotates around the longitudinal axis L, the slidable insert 218 moves distally toward the closed distal end 206 to compress the compressible absorbent material 214 and release the disinfectant. The proximal end 236 of the insert 218 may have a key 238, which is configured to engage with the fluid path element 106 (e.g., chamber 112). In this way, when the disinfection cap 200 is connected to the fluid path element 106, the corresponding feature engagement key 238 on the end of the chamber 112 makes the disinfection cap 200 move the sliding insert 218 in the distal direction by the threaded engagement between the threaded distal end 234 and the housing 202 around the rotation of the longitudinal axis L. This distal movement compresses the compressible absorbent material 214 to release the disinfectant fluid to disinfect the fluid path element 106 .

[0162] In an alternative embodiment, a threaded portion may be located on the sliding insert 218 and may be configured to interact with an associated protrusion on an inner surface portion of the disinfection cap 200 to screw 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 with corresponding features on the end of the fluid path element 106, such as a fluid diverter element (see, e.g., International PCT Application No. PCT / US2021 / 018523), to maintain the slidable insert 218 in a non-rotated position when the disinfection cap 200 is rotated.

[0163] In another embodiment, the disinfection cap 200 may include a slidable insert 218 that is a one-touch screw structure. According to this embodiment, the action of pushing the disinfection cap 200 onto the fluid path element 106 in the direction of the longitudinal axis L causes the slidable insert 218 to engage with the threaded portion of the disinfection cap 200 and spin / rotate the slidable insert 218 during the engagement process, thereby compressing the compressible absorbent material 214 and releasing the disinfectant liquid from the compressible absorbent material 214 to disinfect the surface of the fluid path element 106.

[0164] refer to Figures 4A-4C , the disinfection cap 200 may have a keyed anti-rotation compressible absorbent material 214. For example, the disinfectant-saturated compressible absorbent material 214 may have one or more anti-rotation grooves 242 (e.g., Figure 4C ), the anti-rotation groove 242 is configured to engage with one or more corresponding anti-rotation protrusions 244 (such as Figure 4A One or more anti-rotation grooves 242 may be configured to receive one or more anti-rotation protrusions 244 so that the compressible absorbent material 214 rotates as the disinfection cap 200 rotates about the longitudinal axis L (as shown). Figure 4A In some embodiments, the positions of the one or more anti-rotation grooves 242 and the one or more anti-rotation protrusions 244 can be reversed, such that the one or more anti-rotation grooves 242 are disposed on the inner surface 228 of the housing 202, and the one or more anti-rotation protrusions 244 are disposed on the compressible absorbent material 218.

[0165] Because the compressible absorbent material 218 is keyed to and rotates with the disinfection cap 200, when the disinfection cap 200 is pushed toward the fluid path element 106, the keying elements (i.e., one or more anti-rotation grooves 242 and one or more anti-rotation protrusions 244) engage, so that the absorbent material 218 rotates with the disinfection cap 200. In this way, when the disinfection cap 200 rotates about the longitudinal axis L, the compressible absorbent material 218 scrubs one or more surfaces of the fluid path element 106 while releasing disinfectant, thereby enhancing the disinfecting action. Although the keying arrangement is described as including one or more anti-rotation grooves 242 and one or more anti-rotation protrusions 244, other complementary keying features can be incorporated into the disinfection cap 200 and the compressible absorbent material 218 and still be within the scope of the present embodiment.

[0166] refer to Figure 5A Various embodiments of the compressible absorbent material 218 may have an annular groove 246 recessed into the proximal surface 248 (see Figures 4A-4C Circumferential groove 246 may be configured to engage a distal edge of outer skirt 116 of fluid path element 106 ( Figure 5B ), such that the compressible absorbent material 218 engages the inner and outer surfaces of the outer skirt 116. In certain embodiments, the compressible absorbent material 218 may be keyed to engage with the inner surface 228 of the housing 202, as described herein, such that the compressible absorbent material 218 rotates with the disinfection cap 200 during the disinfection process, thereby scrubbing and disinfecting the engaging surfaces 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 disinfection solution and are effectively disinfected due to contact with the compressible absorbent material 218 during the scrubbing process. Alternatively, in another embodiment, the compressible absorbent material 218 having the circumferential grooves 246 may be used as a stand-alone disinfection element without a keyed connection to the housing 202. According to this alternative embodiment, the user would simply engage the compressible absorbent material 218 with the fluid path element 106 and rotate the absorbent element to scrub and disinfect the inner and outer surfaces of the outer skirt 116 of the fluid path element 106.

[0167] refer to Figures 6A-6D According to another embodiment of the present disclosure, the disinfection cap 200 may include a slidable plunger 250 that can move relative to the housing 202 in the direction of the longitudinal axis L (eg, Fig. 6A218 to compress the compressible absorbent material 218 and release the disinfectant therefrom. The disinfection cap 200 may include a housing 202 configured to fit over at least a portion of the fluid path element 106, wherein 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 allow a user to attach, activate, and remove the disinfection cap 200 by gripping the gripping element 212. Other configurations of the gripping element 212 are also contemplated.

[0168] Continue to refer Fig. 6A , the inner flange 254 can extend radially inward from the inner surface 228 of the housing 202 to the inner volume 210. The inner flange 254 can include one or more fluid passages 255 extending therethrough to allow disinfectant 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 can include a sealing surface 258 on the proximal side 262. In certain embodiments, the sealing surface 258 can be on a proximal extending protrusion 256 located at a central portion of the inner flange 254 and surrounded by the one or more fluid passages 255. The sealing surface 258 can be configured to seal the cavity 112 of the fluid path element 106 to prevent any disinfectant fluid from entering the interior volume of the cavity 112 when the disinfection cap 200 is connected to the fluid path element 106.

[0169] Continue to refer Fig. 6A , the disinfection cap 200 may have a compressible absorbent material 218 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 218 is compressed, thereby releasing the disinfectant fluid therefrom. The disinfectant fluid can then flow through one or more fluid passages 255 to contact the fluid path element 106. One or more radially inwardly projecting protrusions 230 or retaining protrusions may be provided on the inner surface 228 of the housing 202 at the open proximal end 204 to interact with corresponding features or grooves on the fluid path element 106, as described herein with reference Figures 2A-2F described.

[0170] According to another embodiment, the compressible absorbent material 218 may be located on each side of the inner flange 254. For example, the compressible absorbent material 218 may have a first compressible absorbent material 218a on the distal side 260 of the inner flange 254 and a second compressible absorbent material 218b on the proximal side 262 of the inner flange 254. This arrangement of the first and second compressible absorbent materials 218a, 218b is similar to the arrangement of the first and second compressible absorbent materials 218a, 218b described herein with reference to Figure 3A-3BThe second compressible absorbent material 218b adjacent to the fluid path element 106 may have a circumferential groove 246 to engage the internal features and the outer surface of the outer skirt 116, as described herein with reference Figures 5A-5C described.

[0171] refer to Figure 6C-6D , the slidable plunger 250 may include a pressing surface 264, which is configured to allow a user to press and activate the disinfection cap 200 to release the disinfectant. For example, the user can grasp the gripping element 212 of the housing 202 with the index and middle fingers of his hand, and press the pressing surface 264 of the slidable plunger 250, such as with his thumb, to start 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 rounded ribs or flat surfaces.

[0172] In certain embodiments, the pressing surface 264 can be configured to allow the slidable plunger 250 to rotate about the longitudinal axis L (eg, Figure 6B 264 ). According to this embodiment, the gripping feature on the pressing surface 264 can be in the form of one or more flat radially extending wings that can be grasped by the user's other hand to assist in the rotational activation of the disinfection cap 200. In such an embodiment, the slidable plunger 250 can be threadedly engaged with the inner flange 254 so that the rotational movement of the slidable plunger 250 about the longitudinal axis L moves the slidable plunger 250 axially toward the inner flange 254. Therefore, the activation of the disinfection cap 200 includes rotating the slidable plunger 250 clockwise or counterclockwise to thread the slidable plunger 250 in the proximal direction to the activated state, thereby pressurizing and forcing the disinfectant fluid through one or more fluid passages 255.

[0173] 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 can be configured to define an internal volume 210 ( Fig. 6A ). The interior volume 210 of the disinfection cap 200 can be configured to contain disinfectant liquid therein. In certain embodiments, the disinfectant liquid can be at least partially absorbed into the compressible absorbent material 214 retained in the interior volume 210, such that during activation of the disinfection cap 200, compression of the compressible absorbent material 214 releases at least a portion of the disinfectant liquid. Alternatively, the interior volume 210 can contain only primarily disinfectant liquid within the volume, such that movement of the slidable plunger 250 toward the proximal end 204 of the housing 202 forces the disinfectant liquid through one or more passages 256 in the inner flange 254.

[0174] The slidable plunger 250 may be retained within the housing 202 by a tapered fit, a friction fit, or one or more protrusions 268 on the peripheral surface of the slidable plunger 250 or the inner surface 228 of the housing 202, so that the slidable plunger 250 remains stationary unless a predetermined force is applied to the pressing surface 264 to overcome the friction of the one or more protrusions 268. In some embodiments, the sliding of the slidable plunger 250 may be prevented unless a minimum force is applied to the pressing surface 264, such as 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. Activation of the disinfection cap 200 will then require application of sufficient force to the slidable plunger 250 to move the slidable plunger 250 past or over the one or more protrusions 268 or flexible tabs. The slidable plunger 250 is slidable between a first inactive state, in which the slidable plunger 250 is located at the open distal end 252 of the housing 202 and defines the interior volume 210, and a second active state, in which the slidable plunger 250 is axially moved in a proximal direction by applying pressure to the pressing surface 264. When the slidable plunger 250 moves to the active state, the proximal end 266 of the slidable plunger 250 compresses the compressible absorbent material 214 and / or the disinfectant fluid in the interior volume 210, resulting in an increase in the pressure of the disinfectant fluid in the interior volume 210. Once the pressure of the disinfectant fluid in the interior volume 210 reaches a threshold pressure, the disinfectant fluid is forced through one or more fluid passages 256 in the inner flange 254 and contacts one or more surfaces of the fluid path element 106, thereby disinfecting the surfaces. Other embodiments may include a one-way valve extending through the inner flange 254 so that the disinfectant fluid flows through the one-way valve to contact the fluid path element 106.

[0175] After activation, disinfection cap 200 remains engaged with fluid path element 106 in an activated state for a predetermined length of time sufficient to sterilize all exterior surfaces from any microorganisms or pathogenic substances. Disinfection cap 200 may also serve as a dust cap to prevent contamination of the distal end of fluid path element 106 by dust particles that may be floating in the air of the infusion set. Disinfection cap 200 may remain in place until the next patient and infuser are ready for the subsequent patient infusion procedure, at which time they may be removed and the disinfected / sterilized distal end of multi-patient fluid path element 106 may be engaged with the proximal end of single-patient fluid path element 108.

[0176] refer to Figure 7A-7B, the slidable plunger 250 and the inner flange 254 are threadedly connected by a thread arrangement 270. In some embodiments, the thread arrangement 270 has corresponding threaded surfaces that, when rotated, cause the slidable plunger 250 to slide axially between an inactive state and an activated state. The slidable plunger 250 may include a fluid reservoir 272 for containing a certain amount of disinfectant. The distal wall 274 of the slidable plunger 250 is made of a flexible, deformable elastic material. In some embodiments, the fluid reservoir 272 may also include a compressible absorbent material at least partially impregnated with disinfectant.

[0177] Continue to refer Figure 7A-7B , the proximal end 262 of the slidable plunger 250 has one or more pressure-activated passages 276 so that the disinfectant can flow through the pressure-activated passages 276 when pressurized. In this embodiment, the disinfection cap 200 does not need to include compressible absorbent material and / or disinfectant in the internal volume 210 defined between the slidable plunger 250 and the inner flange 254. Instead, during the rotatable movement of the slidable plunger 250 from the inactive state to the activated state, the user can apply pressure to the distal wall 274 of the slidable plunger 250 during or after the slidable plunger 250 has rotatably contacted the inner flange 254. Therefore, the disinfectant in the fluid reservoir 272 is pressurized and flows through the pressure-activated passage 276 and the one or more passages 255 in the inner flange 254 to contact and any outer surface of the disinfectant path element 106 (such as Figure 7B 276 . In some embodiments, the pressure activated passage 276 can be in a normally closed position before the slidable plunger 250 is activated by pushing the distal wall 274 in the proximal direction. The disinfection cap 200 can include a fluid path sealing surface 222 as described herein that forms a fluid tight seal with the cavity 112 of the fluid path element 106 and prevents any disinfection fluid or other contaminants from entering the cavity 112.

[0178] In some embodiments, the fluid reservoir 272 may include a membrane on the pressure-activated passage 276 to retain the disinfectant. When sufficient pressure is applied to the distal wall 274 in the proximal direction, the disinfectant in the fluid reservoir 272 is pressurized to a pressure sufficient to break the membrane and allow the disinfectant to flow out of the fluid reservoir 272.

[0179] refer to Figures 8A-8BThe disinfection cap 200 has a housing 202, the housing 202 including an open proximal end 204, a closed distal end 206, and a sidewall 208, the open proximal end 204 being configured to releasably engage the outer surface of the fluid path element 106, the closed distal end 206 being closed by a flexible, deformable elastic membrane 278, and the sidewall 208 extending between the open proximal end 204 and the closed distal end 206. The disinfection cap 200 also includes an internal fluid reservoir 280 defined by a flexible, deformable elastic membrane 280, an inner surface 228 of a distal portion of the sidewall 208, and an inner flange 254 extending radially inward from the sidewall 208 to define the internal fluid reservoir 280. The internal fluid reservoir 280 can be filled with a disinfectant. In some embodiments, the internal fluid reservoir 280 can also include a compressible absorbent material, such as described herein with reference to Figures 2A-2F The compressible absorbent material described herein is at least partially saturated with a disinfectant solution. In certain embodiments, the compressible absorbent material, such as a sponge, can act as a spring to maintain the flexible, deformable elastic membrane 278 in an expanded state when no pressure is applied, and release the disinfectant solution when a user applies pressure to the flexible, deformable elastic membrane 278. After the user releases the pressure on the elastic membrane 278, the compressible absorbent material can return to its original uncompressed state. When the compressible absorbent material returns to the non-compressed state, it can absorb excess disinfectant solution and return the elastic membrane 278 to the extended state, at which time the elastic material can be compressed again.

[0180] The inner flange 254 may include a fluid path sealing surface 222 (eg, Fig. 8A The fluid path sealing surface 222 may be configured to seal the cavity 112 of the fluid path element 106 (eg, Figure 8B 106 when the disinfection cap 200 is activated, or to prevent any disinfection liquid from entering the interior volume of the cavity 106, or to prevent any liquid from dripping from the interior of the cavity 112. The inner flange 254 may also include one or more fluid passages 255 as described herein, which allow fluid communication between the internal fluid reservoir 280 and the proximal interior volume 210 of the disinfection cap 200.

[0181] Once engaged with the fluid path element 106, such as after removing a used single-patient fluid path element, the disinfection cap 200 can be activated by applying pressure to the flexible, deformable elastic membrane 278 in a proximal direction. For example, the user can apply pressure by pressing the elastic membrane 278 with a thumb or other finger. Once the disinfectant fluid therein reaches a predetermined pressure, one or more fluid passages 276 can open, allowing the disinfectant fluid to flow through the fluid passages 255 and contact one or more surfaces of the fluid path element 106. After activation, the disinfection cap 200 can remain engaged with the fluid path element 106 in an activated state for a period of time sufficient to disinfect the outer surface of the fluid path element 106 to remove any microorganisms or pathogenic substances.

[0182] refer to Figures 9A-9B , the disinfection cap 200 may include a housing 202, the housing 202 having an open proximal end 204, a closed distal end 206 and a sidewall 208 extending between the open proximal end 204 and the closed distal end 206. The disinfection cap 200 may also include a sealing member 282 attached to an inner surface 228 of the sidewall 208. When the fluid path element 106 is connected to the disinfection cap 200, the sealing member 282 may be configured to seal the internal volume of the cavity 112 of the fluid path element 106 to prevent the entry of contaminants or the outflow of fluid therefrom. A thin deflectable material 284 extends radially outward from the sealing member 282 toward the inner surface 228 of the sidewall 208. The deflectable material 284 in a non-deflected state defines the proximal end of the internal volume 210 of the disinfection cap 200 together with the sealing member 282 and the closed distal end 206.

[0183] The near end of internal volume 210 may include compressible absorbent material 214, which is at least partially soaked with disinfectant. By pressing the far end of disinfection cap 200 or otherwise moving disinfection cap 200 to the proximal direction, disinfection cap can move from the first inactive state to the second activated state. When disinfection cap 200 is activated, for example, by pushing fluid path element 106 to the far end 206 of disinfection cap 200, the far end of the cavity 112 of fluid path element 106 pushes sealing member 282, thereby the inside of sealing cavity 112, and deflects thin deflectable material 284. This movement reduces the volume of internal fluid volume, and compresses compressible absorbent material 214 and the disinfectant contained therein. Then, pressurized fluid is pressed against thin deflectable material 284, material is deflected to the proximal direction, and allows disinfectant to flow through thin deflectable material, and contacts one or more outer surfaces of fluid path element 106. The disinfectant fluid contacts various surfaces of fluid path element 106 for a predetermined length of time, such as from a few seconds to seven days, effectively disinfecting the contacted surfaces.

[0184] refer to Fig. 10A, the disinfection cap 200 may include a proximal end 204 having an inner diameter D1 that is greater than an inner diameter D2 of a closed distal end 206. As described herein, the distal end 206 may include an internal fluid reservoir 280 defined by the closed distal end 206, a distal portion of the sidewall 208, and a sealing member 282. As described herein, the internal fluid reservoir 280 may be filled with a disinfection liquid or an absorbent material 214 at least partially impregnated with a disinfection liquid.

[0185] The sealing member 282 can include a flexible flange 286 extending around at least a portion of the circumference of the fluid path sealing portion 222. The sealing member 280 can seal against an edge 288 formed at the transition between the larger inner diameter D1 and the smaller inner diameter D2, thereby preventing the release of disinfectant from the internal fluid reservoir 280 when the disinfection cap 280 is in an inactive state. As described herein, the pressure of the cavity 112 of the fluid path element 106 on the proximal sealing surface of the sealing member 282 can create a fluid tight seal between the interior of the cavity 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 can break the seal between the sealing member 282 and the edge 288 and push the sealing member 282 into the interior volume of the distal end 206 as the flexible flange 286 bends. As pressure increases on the disinfectant liquid or the compressible absorbent material at least partially impregnated with the disinfectant liquid, the disinfectant liquid is released toward the fluid path element 106 around the perimeter of the curved flexible flange 286, coating the cavity 112 and one or more of the outer surfaces of the fluid path element 106 surface, and disinfecting the end 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 larger diameter proximal portion of the disinfection cap 200. The ring 290 of absorbent material (see Fig. 10B ) can help maintain the seal between the sealing member 282 and the edge 288 and can contact the outer surface of the fluid path element 106 to absorb excess disinfectant and ensure that the fluid path member 106 is completely coated with the disinfectant.

[0186] refer to Figures 11A-11B , the distal end 113 of the fluid path element 106 may include features to prevent one or more movable elements from causing microbial or pathogen contamination of the cavity 112 of the fluid path element 106. For example, in a first embodiment, the fluid path element 106 may include a cover 130 to prevent contamination of the cavity 112 and to prevent fluid from dripping from the end of the fluid path element 106. The cover 130 may include a hood 160 with a movable protective support 162 and a compressible side cover 166. Figures 11A-11BAs shown, the distal end 113 of the fluid path element 106 has a cover 160 surrounding the fluid path element 106. The distal end of the cover 160 has a movable two-piece structure having a seal protection support 162 positioned on the cavity 112. The single-patient fluid path kit 108 can have a pair of flexible legs 121 that are configured to pivot radially outward about a pivot point 123. When the ends of the extended flexible legs 121 of the single-patient fluid path kit 108 contact the distal surface of the cover 160, the seal protection support 162 moves from a covering position ( Fig.11A ) to an uncovered position ( Fig. 11B When lumen 129 of single-patient fluid path kit 108 engages lumen 106 of fluid path element 106, compressible side cover 166 is then in an uncompressed position ( Fig.11A ) is compressed to the compressed position ( Fig. 11B ).

[0187] refer to Figures 12A-12B , cover 130 may be disposed at the distal end of single-patient fluid path kit 108. For example, compressible side cover 166 may extend around cavity 129 of single-patient fluid path kit 108 and may be configured to be compressed in the proximal direction when cavity 112 of fluid path element 106 contacts seal protection support 162, thereby causing the two-piece structure to be compressed from a covering position ( Fig. 12A ) to an uncovered position ( Fig. 12B When lumen 112 of fluid path element 106 is engaged with lumen 129 of single-patient fluid path kit 108, compressible side cover 166 is in an uncompressed position ( Fig. 12A ) is compressed to the compressed position ( Fig. 12B ).

[0188] When single-patient fluid path kit 108 is engaged with multi-patient fluid path element 106, single-patient fluid path kit 108 moves flexible engagement legs 121 in a radially outward direction. As engagement legs 121 flex outwardly, silicone sealing members move apart, thereby allowing access to lumen 106 of multi-patient fluid path element 106 so that single-patient fluid path kit 108 can engage therewith.

[0189] refer to Figures 13A-13C, the housing 202 of the disinfection cap 200 may include a sealing edge 292 extending radially inward from the inner surface 228 of the side wall 208. The sealing edge 292 is located 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 can be sealingly seated proximal to the sealing edge 292, so 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, which define a fluid passage through which the disinfectant flows. 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 one described herein with reference to Figures 2A-2F The compressible absorbent material 214 is depicted as being at least partially saturated with an antiseptic solution. Alternatively, the distal fluid volume 294 may simply contain a volume of antiseptic solution that is sealingly retained within the distal fluid volume 294 by the slidable plunger 250 .

[0190] When the disinfection cap 200 is releasably engaged with the distal end of the fluid path element 106, the fluid path element 106 contacts the slidable plunger 250 in the first inactive state. In certain embodiments, the slidable plunger 250 can form a fluid tight seal against the distal end of the cavity 112 of the fluid path element 106, as described herein, thereby sealing the cavity 112 and preventing contamination of the cavity 112 and / or fluid from dripping from the cavity 112. Moving the disinfection cap 200 from the first inactive state to the second active state includes further pressing the disinfection cap 200 onto the fluid path element 106, so that the fluid path element 106 is further inserted into the interior volume 210 of the housing 202 toward the closed distal end 206. Additional movement of the disinfection cap 200 relative to the fluid path element 106 can push the slidable plunger 250 past the sealing edge 292, thereby reducing the volume of the distal fluid volume 294 and pressurizing the disinfectant contained therein.

[0191] When the slidable plunger 250 is pushed through the proximal end of the plurality of longitudinal grooves or longitudinal protrusions 296 by the movement of the fluid path element 106 ( Fig. 13C ), the disinfectant can flow through the plurality of longitudinal grooves or around the plurality of longitudinal protrusions 296 through the slidable plunger so that the disinfectant can contact the outer surface of the fluid path component 106. The disinfectant contacts the various surfaces of the fluid path component 106 for a predetermined length of time, such as from a few seconds to 7 days, effectively disinfecting the contacted surfaces.

[0192] refer to Figures 14A-14D , the disinfection cap 200 may have a slidable plunger 250 (eg Figures 14B-14D), the slidable plunger 250 has 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 pushed toward the fluid path element 106 to the activated position, the inner sealing member 298 moves out of contact with the inner surface sealing seat 300 and moves toward the closed distal end 206 of the housing 202. Similar to the present invention, the inner sealing member 298 is similar to the inner sealing member 298 of the present invention. Figures 13A-13C In the embodiment discussed, the inner surface 228 of the side wall 208 at the distal end of the inner surface seal seat 300 may include a plurality of longitudinal grooves or protrusions 296 that define a fluid path through which the disinfectant fluid flows. Once the slidable plunger 250 is pushed distally away from the inner surface seal seat 300, the disinfectant fluid contained in the distal fluid volume 294 may flow toward the fluid path element 106 in a proximal direction through the plurality of longitudinal grooves or protrusions 296.

[0193] like Fig. 14B As shown, the slidable plunger 250 has an extended feature 302 that defines a fluid path sealing surface 222 that is used to seal the cavity 112 of the fluid path element 106 in an unactivated position (when the cavity 112 first contacts the slidable plunger 250) and in an activated position (when the fluid path element 106 pushes the slidable plunger 250 distally toward the closed distal end 206).

[0194] refer to Figures 15A-15E , shows a disinfection cap 200 according to another embodiment of the present disclosure. Fig. 15C As shown, the housing 202 of the disinfection cap 200 has a lateral opening 304 between the open proximal end 204 and the closed distal end 206. The lateral opening 304 extends through the side wall 208 of the housing 202 into the interior volume 210 of the housing 202. In some embodiments, the lateral opening 304 can be configured to receive an insertable tray 306 (e.g., a disposable tray) containing a compressible absorbent material 214. Fig. 15B and 15E 106 ). The lateral opening 304 has at least one lateral groove 308 configured to receive at least a portion of an insertable tray 306 that allows rotational movement of the tray 106 relative to the housing 202 to provide a scrubbing action between the compressible absorbent material 214 and the fluid path element 106 when the tray 106 is inserted into the housing 202 and contacts a surface of the fluid path element 106.

[0195] refer to Fig.15E The insertable tray 306 has a receiving portion 310 and a handle tab 312, the receiving portion 310 being configured to receive the compressible absorbent material 214 (e.g., Fig.15D304 ), the handle tab 312 extends radially outward from the receiving portion 310. The receiving portion 310 can be sized to be received within the lateral opening 304, and the handle tab 312 can be configured to be received within the lateral recess 308 of the lateral opening 304 during the rotational action. The insertable tray 306 can be inserted into the interior 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 (as shown in FIG. Fig. 15B Once inserted, the insertable tray 306 can be reciprocated or rotated in a direction about the longitudinal axis L by the user grasping the handle tab 312 to provide a scrubbing action between the compressible absorbent material 214 and the fluid path element 106. As described herein, the compressible absorbent material 214 and the insertable tray 306 can have corresponding anti-rotation grooves 242 and anti-rotation protrusions 244 for preventing the compressible absorbent material 214 from rotating relative to the insertable tray 306.

[0196] like Fig.15E As shown, the insertable tray 306 may be provided with a removable seal 314 to seal the compressible absorbent material 214 in the tray 306 and retain the disinfectant. The removable seal 314 can be removed before the insertable tray 306 is inserted into the disinfection cap 200. In another embodiment, the insertable tray 306 and the compressible absorbent material 214 can be provided without the disinfectant, and the removable seal 314 can be provided to maintain the sterility of the internal volume of the insertable tray 306. Before inserting the disinfection cap 200, the removable seal 314 can be removed, and the compressible absorbent material 214 can be saturated with the disinfectant from the body fluid source. In certain embodiments, the compressible absorbent material 214 can be provided in the form of defining a central opening 216, which substantially corresponds to the outer diameter of the cavity 112 of the fluid path element 106. During the contact between the compressible absorbent material 214 and the fluid path element 106, the cavity 112 of the fluid path element 106 may not contact the compressible absorbent material 214. In other embodiments, the compressible absorbent material 214 may not include the central opening 216 .

[0197] refer to Figures 16A-16B, the disinfection cap 200 may include a slidable plunger 250 having an internal chamber 316 configured to contain a certain volume of disinfectant. The slidable plunger 250 may be configured to reciprocate in the direction along the longitudinal axis L within the internal volume 210 of the housing 202. The slidable plunger 250 has a cylindrical body 318 with a pair of retaining flanges 320, which interact with the distal flange 322 at the open distal end 252 of the housing 202, and the retaining flange 320 defines the travel of the slidable plunger 250 relative to the housing 202. In some embodiments, the slidable plunger 250 may also be configured to rotate around the longitudinal axis L.

[0198] Continue to refer Figures 16A-16B , the proximal end 324 of the slidable plunger 250 is connected to the compressible absorbent material 214. For example, the compressible absorbent material 214 can have a groove 326 that is configured to receive the proximal retaining flange 320 of the slidable plunger 250. In this way, the compressible absorbent material 214 can move with the movement of the slidable plunger 250. Once the disinfection cap 200 is connected to the fluid path element 106, the internal volume 316 of the slidable plunger 250 can be filled with disinfectant so that the disinfectant at least partially saturates the compressible absorbent material 214. When the slidable plunger 250 is axially moved toward and away from the fluid path element 106 in the direction along the longitudinal axis L, such as by a user grasping the distal retaining flange 320 and the gripping element 212, the compressible absorbent material 214 contacts the fluid path element 106 to disinfect the fluid path element 106. In some embodiments, the slidable plunger 250 can also be rotated about the longitudinal axis L to scrub the fluid path element 106.

[0199] refer to Figures 17A-17C , shows a disinfection cap 200 according to another embodiment, which is Figures 16A-16B A variation of the embodiment shown. Figures 16A-16B As shown, the proximal end 324 of the slidable plunger 250 can have a wider diameter than the diameter of the cylindrical body 318, rather than the cylindrical body 318 having a uniform diameter throughout its length. In some embodiments, the proximal end 324 can define a receiving cavity 328 for receiving the compressible absorbent material 214 therein. As described herein, the compressible absorbent material 214 can include a circumferential groove 246 for interfacing with the outer skirt 116 of the fluid path element 106. The wider diameter of the portion of the sidewall 208 of the disinfection cap 200 can also serve as a gripping element 212 when the slidable plunger 250 is compressed.

[0200] refer to Figures 18A-18BThe disinfection cap 200 may include a housing 202 having an open proximal end 204 and a closed distal end 206, wherein a side wall 208 extends between the open proximal end 204 and the closed distal end 206 to define an interior volume 210 (eg, Fig.18B 330). The compressible absorbent material 214 is retained within the interior volume 210 and is connected to the closed distal end 206 by an adhesive pad 330. In some embodiments, the adhesive pad 330 may include a low temperature melting polymer. The proximal end of the compressible absorbent material 214 may include a fluid-impermeable coating that is configured to sealably engage the cavity 112 of the fluid path element 106 to prevent the disinfectant solution from entering the fluid path of the cavity 112. For example, the fluid-impermeable coating may include a layer of a closed cell polymer, a silicone layer, a polymer layer, or other suitable material that is adhered to the proximal end of the compressible absorbent material 214. The closed distal end 206 may have a retainer 331, such as a circumferential wall protruding proximally from the closed distal end 206, for retaining the compressible absorbent material 214.

[0201] refer to Figures 19A-19B , shows a disinfection cap 200 according to another embodiment of the present disclosure. The inner surface 228 of the shell 202 can have one or more protrusions 332 protruding radially inward from the inner surface 228. One or more protrusions 332 can extend along at least a portion of the longitudinal length of the shell 202 in the direction of the longitudinal axis L. In some embodiments, one or more protrusions 332 can be configured as a helical thread that is configured to threadably engage with a corresponding thread on the compressible absorbent material 214. In other embodiments, one or more protrusions 332 can be configured to compressively retain the compressible absorbent material 214, for example due to an interference fit. The proximal end of the compressible absorbent material 214 may include a fluid-impermeable coating that is configured to sealably engage the cavity 112 of the fluid path element 106 to prevent disinfectant from entering the fluid path of the cavity 112, as described herein.

[0202] refer to Figures 20A-20D , shows a disinfection cap 200 according to another embodiment of the present disclosure. The closed distal end 206 may have a retaining pocket 334 that is configured to retain the compressible absorbent material 214. In some embodiments, the retaining pocket 334 may have a smaller inner diameter than 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, such as at the transition between the retaining pocket 334 and the inner surface 228 of the housing 202 or elsewhere in the retaining pocket 334, to securely engage and contain the distal end of the compressible absorbent material 214 in the retaining pocket 334.

[0203] In some embodiments, the retaining pocket 334 may include one or more longitudinal ribs 338 extending radially inwardly and configured to engage the side surfaces of the compressible absorbent material 214. Fig.21 C-21D), one or more longitudinal ribs 338 can prevent the compressible absorbent material 214 from rotating to create a scrubbing effect between the fluid path element 106 and the compressible absorbent material 214, thereby affecting the disinfection effect of the fluid path element 106. In certain embodiments, as described herein, a fluid-impermeable coating or film 340 can be attached to the proximal surface of the compressible absorbent material 214 to act as a barrier to prevent the disinfectant fluid from the compressible absorbent material 214 from moving into the cavity 112 of the fluid path element 106. According to these embodiments, the film 340 can be attached or otherwise adhered to the surface of the compressible absorbent material 214, such as by an adhesive, co-molding, or melting process on the front surface of the compressible absorbent material 214, to close the open pores of the compressible absorbent material 214 and prevent fluid from flowing through a portion of the surface of the compressible absorbent material 214.

[0204] refer to Fig.21 , 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. In this embodiment, the compressible absorbent material 214 may provide a scrubbing and disinfecting effect (e.g., Figure 1B 228 of the housing 200), while the outer cylindrical sleeve 342 can provide a scrubbing and disinfecting action on the exterior of the fluid path element 106. The outer cylindrical sleeve 342 can be retained by one or more retaining undercuts 336 protruding from the inner surface 228 of the housing 200. The proximal end of the compressible absorbent material 214 can include a fluid-impermeable coating that is configured to sealingly engage the lumen 112 of the fluid path element 106 to prevent disinfecting fluid from entering the fluid path of the lumen 112, as described herein.

[0205] refer to Figures 22A-22B , the disinfection cap 200 may have a consistent 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 protruding radially inward from the inner surface 228. In some embodiments, the one or more longitudinal ribs 338 may be configured to engage with the compressible absorbent material 214 to prevent the disinfection cap 200 from being displaced relative to the fluid path element 106 (e.g., Figure 1BDuring the twisting action of the compressible absorbent material 214 (as shown), the compressible absorbent material 214 rotates relative to the housing 202, thereby affecting a scrubbing action on the fluid path element 106. 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 disinfectant fluid from entering the fluid path of the lumen 112, as described herein.

[0206] refer to Figures 23A-23D , shows a disinfection cap 200 according to other embodiments of the present disclosure. Figures 23A-23B The compressible absorbent material 214 has a central opening 216, and Figures 23C-23D The compressible absorbent material 214 in the embodiment has a protruding fluid path sealing surface 222. As described herein, the compressible absorbent material 214 in either embodiment can have a fluid-impermeable coating, film, or laminate 344 adhered or otherwise attached to the proximal surface 248 of the compressible absorbent material 214. In some embodiments, the film or laminate 344 can cover the entire proximal surface 248 such that the film or laminate 248 extends substantially to the outer circumference of the compressible absorbent material 214. According to certain embodiments, the film or laminate 344 can include one or more perforations 346 that allow disinfectant fluid to flow from the compressible absorbent material 214 through the film or laminate 344 and contact the fluid path element 106 to disinfect the surface of the fluid path element 106.

[0207] In other embodiments, a first portion of the film or laminate 344 may be adhered to a central region of the compressible absorbent material 214, and the remainder of the film or laminate 344 is preferably not adhered to the compressible absorbent material 214. According to these embodiments, when the fluid path element 106 (e.g., Figure 1B When the film or laminate 344 (shown in FIG. 1 ) is inserted into the disinfection cap 200 and compresses the compressible absorbent material 214, the unadhered portion (i.e., the perimeter) of the film or laminate 344 is folded away from the compressible absorbent material 214 and around the fluid path element 106. When the film or laminate 344 is folded, a passage is defined between the fluid path element 106 and the inner surface 228 of the disinfection cap 200, which allows disinfectant fluid to flow from the compressible absorbent material 214 to at least a portion of the fluid path element 106 where the disinfectant fluid can contact and disinfect the fluid path element 106.

[0208] refer to Figures 24A-24C , shows a disinfection cap 200 according to another embodiment of the present disclosure. Fig.24AAs shown, the disinfection cap 200 may include a housing 202 having an open proximal end 204 and a closed distal end 206, with a sidewall 208 extending between the open proximal end 204 and the closed distal end 206 to define an interior volume 210. The disinfection cap 200 has an inner sleeve 348 protruding from an inner surface 350 of the closed distal end 206. In some embodiments, the inner sleeve 348 has a cylindrical shape and extends into the interior volume 210 over at least a portion of the longitudinal length of the housing 202. In some embodiments, the terminal end of the inner sleeve 348 is recessed relative to the open proximal end 204. The inner sleeve 348 defines a receiving space 352 (e.g., a receiving space 352) for receiving the cavity 112 of the fluid path element 106. Fig.24C ). The space 354 between the inner cylindrical sleeve 348 and the inner surface 228 of the sidewall 208 is configured to receive the compressible absorbent material 214. In some embodiments, for example Fig.24A As shown, the compressible absorbent material 214 may be recessed into the space 354, while in other embodiments, for example Fig.24D As shown, the compressible absorbent material 214 can protrude proximally from the space 354 relative to the terminal end of the inner sleeve 348. In another embodiment, the compressible absorbent material 214 can terminate distally of the proximal end of the inner sleeve 348. According to this aspect, before the cavity 112 of the fluid path element 106 seals into the receiving space 352, the disinfectant liquid can be prevented from being squeezed out of the compressible absorbent material 214 and shielded by the inner sleeve 348 of the disinfection cap 200, for example, by the interface between the sealing O-ring on the cavity 112 and the inner side wall of the inner sleeve 348.

[0209] In some embodiments, inner sleeve 348 can be configured to provide a seal with lumen 112 of fluid path element 106 to prevent disinfectant fluid from contacting lumen 112. In some embodiments, the outer surface of lumen 112 can have a seal 140 configured to contact the inner surface of inner sleeve 348 to prevent fluid from entering or exiting lumen 112.

[0210] refer to Fig.24F The outer surface 356 of the inner sleeve 348 may have one or more retaining ribs 358 configured to contact at least a portion of the compressible absorbent material 214 to maintain the compressible absorbent material 214 in a fixed position relative to the inner sleeve 348 (e.g., Fig.24C One or more retaining ribs 358 may extend axially along the longitudinal length of the inner sleeve 348.

[0211] According to another embodiment of a disinfection cap 200 having an inner sleeve 348, the compressible absorbent material 214 can be retained in the space 354 between the inner sleeve 348 and the sidewall 208, and the proximal end of the compressible absorbent material 214 can be flush with the proximal end of the disinfection cap to allow disinfection of the fluid path element 106 without moving any microbial material to the rear of the fluid path element 106.

[0212] refer 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 split by a cylindrical cutout substantially along the length of the outer cylindrical sleeve 342, wherein the cutout is configured to receive the outer skirt 116 of the fluid path element 106. In this embodiment, the compressible absorbent material 214 may provide a scrubbing and disinfecting action on the interior of the fluid path element 106, while the outer cylindrical sleeve 342 may provide a scrubbing and disinfecting action on the exterior of the fluid path element 106. The outer cylindrical sleeve 342 may be retained by one or more retaining undercuts protruding from the inner surface 228 of the housing 200. Additionally, in other embodiments, the split compressible absorbent material 214 may provide a rotational scrubbing action when the disinfection cap 200 is twisted relative to the fluid path element 106. Certain embodiments may include one or more longitudinal ribs, as described herein, to prevent relative movement of the compressible absorbent material 214 and / or the outer cylindrical sleeve 342 during the twisting and scrubbing motion.

[0213] refer to Figures 26A-26B , shows a disinfection cap 200 according to another embodiment of the present disclosure. The inner surface 360 ​​of the inner sleeve 348 may include one or more clamping features 362, which protrude radially inward and are configured to releasably engage at least a portion of the cavity 112 of the fluid path element 106. In some embodiments, one or more clamping features 362 may be configured as continuous or discontinuous ribs extending around the inner circumference of the inner sleeve 348. One or more clamping features 362 may remain connected to the disinfection cap 200 of the fluid path element 106, and resist the restoring force of the compressed absorbent material 214, so that the disinfection cap 200 remains on the fluid path element 106 for at least a suitable period of time, so that the disinfectant disinfects any microbial contaminants on the surface of the fluid path element 106. In certain embodiments, one or more clamping features 362 may also provide tactile and / or auditory feedback to the user, that the disinfection cap 200 has been properly installed on the fluid path element 106.

[0214] refer to Figures 27A-27B, the outer surface 356 of the inner sleeve 348 may include one or more clamping features 362 protruding radially outward, which are configured to releasably engage at least a portion of the cavity 112 of the fluid path element 106. In some embodiments, the one or more clamping features 362 may be configured as continuous or discontinuous ribs extending around the outer circumference of the inner sleeve 348. The one or more clamping features 362 may be configured to engage with the boss 152 on the hole 114 of the outer skirt 116 of the fluid path element 106. The one or more clamping features 362 can maintain the disinfection cap 200 connected to the fluid path element 106 and resist the restoring force from the compressed absorbent material 214, so that the disinfection cap 200 remains on the fluid path element 106 for at least a suitable period of time so that the disinfectant fluid disinfects any microbial contaminants on the surface of the fluid path element 106. In certain embodiments, the one or more clamping features 362 can also provide tactile and / or audible feedback to the user that the disinfection cap 200 has been properly installed on the fluid path element 106.

[0215] refer to Fig.27C , the width of inner sleeve 348 is substantially consistent with the width of space 354 between lumen 112 and outer skirt 116 of fluid path element 106. In some embodiments, outer surface 354 of inner sleeve 348 can have guiding features, such as one or more retaining ribs 358 extending in the longitudinal direction of inner sleeve 348. The guiding features can help prevent smearing or transfer of microbial contaminants from the end of fluid path element 106 to lumen 112.

[0216] refer to Figures 28A-28B , the disinfection cap 200 may include a housing 202 having an inner sleeve 348 protruding from the distal end 206 to the proximal end. In some embodiments, the internal volume 210 may be free of compressible absorbent material, such as 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 may have a retaining clip 366 (such as Fig.28B 2 ), the retaining clip 366 is 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 retain the disinfection cap 200 on the fluid path element 106. The cavity 112 of the fluid path element 106 can be sized to fit within the interior volume 210 of the housing 202 so that the disinfectant within the interior volume 210 can contact the cavity 112.

[0217] Continue to refer Figures 28A-28B, the distal end 206 of the housing 202 has an opening 368 configured to be fluidly connected to the reservoir. In some embodiments, the reservoir can be configured to hold a volume of disinfectant that can be delivered to the interior volume 210 of the housing 202 through the opening 368. The reservoir can be removably connected to the housing 202 via one or more connecting legs 372. The reservoir can have a squeezable bag made of a flexible material so that when the squeezable bag is squeezed by a user, the disinfectant flows out of the reservoir and enters the interior volume 210 of the housing 202 through the opening 368 to disinfect the cavity 112.

[0218] refer to Figures 28C-28D , the disinfection cap 200 may include a housing 202 having an inner sleeve 348 protruding proximally from a distal end 206. In some embodiments, the interior volume 210 may be free of compressible absorbent material, such as according to any of the various non-limiting embodiments described herein. The cavity 112 of the fluid path element 106 may be sized to fit within the interior volume 210 of the housing 202 so that disinfectant within the interior volume 210 may contact the cavity 112. The distal end 206 of the housing 202 has an opening, similar to Figures 28A-28B 202 , the housing 202 may be provided with an opening 368, which is configured to be fluidly connected to a reservoir 370. In some embodiments, the reservoir 370 may be configured to contain a volume of disinfectant that can be delivered to the interior volume 210 of the housing 202 through the opening. The reservoir 370 may be removably connected to the housing 202. In some embodiments, the reservoir 370 may be non-removably (e.g., integrally) formed with the housing 202. The reservoir 370 may have a squeezable bag 374 made of a flexible material. In some embodiments, a seal may be provided on the reservoir 370 to initially seal the disinfectant within the reservoir 370. The seal may be configured to break when the squeezable bag 374 is squeezed, thereby establishing sufficient fluid pressure in the reservoir 370. When the squeezable bag 374 is squeezed by the user, the disinfectant flows out of the reservoir 370 and into the interior volume 210 of the housing 202 to disinfect the cavity 112.

[0219] refer to Fig.29 , shows a disinfection cap 200 according to another embodiment. The disinfection cap 200 has a housing 202 having an open proximal end 204 and an open distal end 252, both of which are sealed by a seal 232. Figure 1B252 ), the seal 232 at the proximal end 204 can be removed by the user.The seal 232 at the open distal end 252 can be irremovably connected to the open distal end 252, to close one or more windows 376 formed in the housing 202, thereby allow the simple manufacture of housing 202, for example, by injection molding.The inner surface 228 of the housing 202 at the open distal end 252 can have one or more barb features 378, which are configured to be maintained in the internal volume 210 of the housing 202 by compressible absorbent material 214. In use, the user first removes the seal 232 at the open proximal end 204 of the sterilizing cap 200, and the sterilizing cap 200 is attached on the fluid path element 106, to sterilize the connector, for example, by scrubbing and / or twisting action.In certain embodiments, whole sterilizing cap 200 can be made of foam or absorbent material, and is placed in foil or anti-fluid bag, for example, has a container that can remove foil seal. The user would remove the foil seal to access the foam cap and then use a sterilization cap 200, such as one made of foam but having one or more of the features described herein, to sterilize fluid path element 200. The proximal end of compressible absorbent material 214 may include a fluid-impermeable coating configured to sealingly engage lumen 112 of fluid path element 106 to prevent sterilization fluid from entering the fluid path of lumen 112, as described herein.

[0220] According to other embodiments, Figures 30A-30B As shown, the disinfection cap 200 may include an elastic reservoir 380 that encloses the inner sleeve 348. The elastic reservoir 380 may be filled with a certain volume of disinfectant. When the disinfection cap 200 is installed on the fluid path element 106 (such as Figure 1B 348 ), the elastic reservoir 380 can be compressed, thereby pressurizing the disinfectant liquid in the elastic reservoir 380. When the disinfectant liquid is compressed, the disinfectant liquid can be forced through the interface between the elastic reservoir 380 and the inner surface or outer surface of the inner sleeve 348. When the disinfectant liquid flows out of the elastic reservoir 380, the liquid fills the space 354 between the housing 202 and the inner sleeve 348 to disinfect the portion of the fluid path element 106 held in the space 354. The proximal surface 382 of the elastic reservoir 380 can be configured to seal the cavity 112 of the fluid path element 106 (as shown in FIG. 1 ). Figure 1B As shown), to prevent disinfectant from entering cavity 112.

[0221] In certain embodiments, such as Figures 31A-31B, a disinfection cap 200 according to another embodiment is shown. The inner surface 228 of the side wall 208 of the disinfection cap 200 may include an elliptical edge 384 and / or an overall shape. The elliptical edge 384 may be defined by one or more protrusions at the proximal end 204, which define the proximal end 204 as having an elliptical shape. The elliptical edge 384 may improve the protrusion or retaining protrusion 230 (such as Figure 2C ) and fluid path element 106 (as shown Figure 1B When the disinfection cap 200 initially contacts the fluid path element 106, the elliptical edge 384 can be configured to bend into a circle to allow passage of the fluid path element 106 during connection of the fluid path element 106 to the disinfection cap 200, and then bend back to the original elliptical shape to allow the protrusion or retention protrusion 230 to engage with the fluid path element 106.

[0222] refer to Figures 32A-32B , shows a disinfection cap 200 according to another embodiment. The seal 232 of the housing 202 can have a guard 386, a portion of which is configured to be received in the interior 349 of the inner sleeve 348 when the seal 232 is connected to the open proximal end 204 of the housing 202. The guard 386 can be formed as a separate component from the seal 232 and then attached to the seal 232, for example, by an adhesive. In other embodiments, the guard 386 can be integrally formed with the seal 232, for example, by molding.

[0223] The compressible absorbent material 214 is received in a 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 disinfectant contained in the compressible absorbent material 214 from entering the interior 349 of the inner sleeve 348, for example during transportation and / or storage of the disinfection cap 200. The guard 386 may have a stepped design having a first portion 351 and a second portion 353, the first portion 351 having a first diameter and configured to fit inside the sidewall 208, and the second portion 353 having a second diameter less than the first diameter and protruding distally from the first portion 351. The second portion 353 may be configured to be received in the interior 349 of the inner sleeve 348. A gap 359 may be provided between the first portion 351 and the inner surface of the seal 232 so that the guard 386 has a substantially uniform thickness between the first portion 351 and the second portion 353.

[0224] A beveled portion 357 may be provided at the transition between the first portion 351 and the second portion 353. The beveled portion 357 of the guard 386 meets the proximal inner edge 355 of the inner sleeve 348 to form a fluid tight seal, thereby preventing the entry of disinfectant fluid from the compressible absorbent material 214, such as during shipping or storage. In this manner, when the seal 232 and the guard 386 are removed from the housing 202, the interior of the inner sleeve 348 will be free of disinfectant fluid that could otherwise enter the cavity 112 (e.g., the cavity 112 of the fluid path element 106) when the disinfection cap 200 is attached to the fluid path element 106. Figure 1B 394). When the cavity 112 is inserted into the inner sleeve 348, a fluid tight seal is formed between the sealing elements, such as an O-ring around the outer surface of the cavity 112 and the inner wall of the inner sleeve 348. As described herein, the outer skirt 116 of the fluid path element 106 releases the disinfectant liquid in response to the compression of the compressible absorbent material 214 to disinfect the various exposed surfaces of the fluid path element 106. In certain embodiments, the sidewall 202 at the proximal end 204 of the disinfection cap 200 may include a widened portion 395 to increase the surface area contact and adhesion between the proximal end of the sidewall 202 and the seal 232. The increased surface area contact and adhesion can prevent accidental disruption of the fluid tight connection between the seal 232 and the proximal end of the sidewall 202, such as during packaging, shipping, unpacking, and / or storage.

[0225] refer to Figures 33A-33B , the guard 386 can be retained at the proximal end of the inner sleeve 348, for example, by the notch 388. In some embodiments, before activating the disinfection cap 200, the interior of the inner sleeve 348 can be filled with disinfectant, and the guard 386 can seal the disinfectant in the interior 349 of the inner sleeve 348. In some embodiments, similar to the embodiments described herein with reference to Figures 2A-2F The depicted compressible absorbent material 214, at least partially saturated with an antiseptic fluid, can fill at least a portion of the interior 349 of the inner sleeve 348. The proximal end of the guard 386 can include a fluid-impermeable coating configured to sealingly engage the lumen 112 of the fluid path element 106 to prevent the antiseptic fluid from entering the fluid path of the lumen 112, as described herein.

[0226] When the fluid path element 106 is initially connected to the sterilization cap 200 ( Fig.33B), cavity 112 of fluid path element 106 contacts guard 386, such that the interior of cavity 112 is sealed by the proximal surface of guard 386. As fluid path element 106 is pushed further distally into interior volume 210 of disinfection cap 200, guard 386 moves away from recess 388 and toward distal end 206 of housing 202. This movement of guard 386 transfers disinfectant from interior 349 of inner sleeve 348 around guard 386 into space 354 to disinfect the surface of fluid path element 106.

[0227] In another embodiment, the interior of the inner sleeve 348 can be free of disinfectant fluid, and the interior volume 210 can include disinfectant fluid, such as substantially absorbed in the cylindrically oriented compressible absorbent material 214 in the space 354 between the inner sleeve 348 and the inner surface 228 of the sidewall 208, as described according to various embodiments herein. When the cavity 112 contacts the guard 386, the cavity 112 is sealed to prevent the ingress of any disinfectant fluid. Further installation of the cap compresses the compressible absorbent material 214 to release the disinfectant fluid from contacting a portion of the fluid path element 106.

[0228] refer to Fig.34A , a plurality of sterilization caps 200 may be connected to the sealing strip 390. For example, in any embodiment describing a sterilization cap 200 having a sealing member 232, such as with reference to Fig.32A and 32B Those described, may be provided where the seal 232 is in the form of a sealing strip 390. Although Fig.34A The disinfection cap 200 is shown without the gripping element 212, but in some embodiments, the disinfection cap 200 can be provided with the gripping element 212. In some embodiments, a sealing strip 390 can extend through the open proximal end 204 of each disinfection cap 200 to close its internal volume. The sealing strip 390 can be an adhesive and / or a frangible seal that is removably attached and covers the open proximal end 204 of the disinfection cap 200. The sealing strip 390 allows the disinfection cap 200 to be transported and stored without loss (e.g., evaporation) and / or contamination of the disinfectant in the internal volume of the housing 202. Each of the multiple disinfection caps 230 can be removed from the sealing strip 390 one by one as needed without affecting the sterility or condition of the remaining disinfection caps 200. As shown in FIG. Fig.34AAs shown, each disinfection cap 200 can include a widened portion 395 located 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 seal 232. The increased surface area contact and adhesion can prevent accidental disruption of the fluid-tight connection between the seal 232 and the proximal end of the side wall 202, such as during packaging, shipping, unpacking and / or storage. The sealing strip 390 can also include a hole 397 to suspend the sealing strip 390 from, for example, a fluid injector or IV pole to allow easy access to the disinfection cap 200 during setup of a subsequent fluid injection procedure. Although each sealing strip 390 can include any number of disinfection caps 200, it is contemplated that each sealing strip 390 will include an even number of disinfection caps 200 because the disinfection caps 200 are typically used in pairs for disinfection of corresponding ends of contrast fluid lines and saline fluid lines associated with a multi-patient fluid path kit 104. As shown in FIG. Fig.34B As shown, a plurality of sealing strips 390, each having a plurality of sterilization caps 200 attached thereto, may be packaged in a box 392 for shipping and bulk storage.

[0229] Although various examples of the present disclosure are provided in the foregoing description, those skilled in the art may modify and change these examples without departing from the scope and spirit of the present disclosure. Therefore, the foregoing description is intended to illustrate rather than limit. The disclosure described above is limited by the appended claims, and all changes to the disclosure that fall within the meaning and equivalent scope of the claims will be included within their scope.

Claims

1. A sterilization cap for a fluid path element, the sterilization cap comprising: a housing configured to fit over at least a portion of the fluid path element, the housing comprising an open proximal end, a closed distal end, and a sidewall extending between the open proximal end and the closed distal end to define an interior volume; a compressible absorbent material at least partially impregnated with a disinfecting fluid, wherein the compressible absorbent material is located within the interior volume of the housing; an insert within the interior volume connected to the compressible absorbent material, the insert movable toward the closed distal end to compress the compressible absorbent material as the fluid path element moves toward the closed distal end, the insert comprising: a fluid path sealing portion configured to seal a cavity on the fluid path element; and A circumferential flange extends around the fluid path sealing portion, the circumferential flange including one or more passages configured to allow the disinfecting fluid to flow from the compressible absorbent material to the fluid path element when the insert is urged toward the closed distal end by the fluid path element.

2. The disinfection cap according to claim 1, wherein: The inner surface of the sidewall includes one or more radially inwardly projecting protrusions configured to removably engage the fluid path element and retain the sterilization cap on the fluid path element.

3. The disinfection cap according to claim 1 or 2, wherein: Movement of the insert toward the closed distal end compresses the compressible absorbent material and releases at least a portion of the antiseptic fluid through the one or more passageways through movement of the fluid path element such that the antiseptic fluid contacts 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 an inner surface of a side wall of the housing.

5. The disinfection cap according to any one of claims 1 to 4, wherein: The fluid path sealing portion includes a rubber material, a pliable plastic material, or a silicone material configured to form a fluid tight seal with the cavity of the fluid path element.

6. The disinfection cap according to any one of claims 1 to 5, wherein the absorbent material is a sponge.

7. The sterilization cap according to any one of claims 1 to 5, wherein the absorbent material is cotton.

8. The disinfection cap according to any one of claims 1 to 7, wherein the disinfectant comprises isopropyl alcohol, ethanol, a combination thereof or an aqueous solution thereof.

9. The disinfection cap of any one of claims 1 to 8, further comprising a gripping flange projecting distally from the closed distal end.

10. The sterilization cap of any one of claims 1 to 9, further comprising a seal removably connected to the open proximal end, wherein the seal fluidly seals the open proximal end.

11. The disinfection cap of claim 10, wherein the seal includes a pull tab projecting radially outwardly relative to a side wall of the housing, wherein the pull tab is configured to remove the seal from the open proximal end.

12. The antiseptic cap of any one of claims 1 to 11, further comprising a second compressible absorbent material located on a proximal surface of the insert and surrounding the fluid pathway sealing portion.

13. The disinfection cap of any one of claims 1 to 12, wherein the insert is threadably connected to the housing such that rotation of the insert relative to the housing moves the insert toward the closed distal end to compress the compressible absorbent material and release at least a portion of the disinfectant solution.

14. The disinfection cap of claim 13, wherein the fluid path sealing portion includes a key configured to engage the fluid path element to rotate the insert relative to the housing as the disinfection cap is rotated.

15. The disinfection cap of any one of claims 1 to 14, wherein an inner surface of the closed distal end comprises one or more ribs configured to prevent rotation of the compressible absorbent material relative to the housing.

16. The disinfection cap according to any one of claims 1 to 15, wherein: The proximal end of the compressible absorbent material includes a groove configured to receive at least a portion of a sidewall of the fluid path element.

17. A sterilization cap for a fluid path element, the sterilization cap comprising: a housing configured to fit over at least a portion of the fluid path element, the housing comprising an open proximal end, an open distal end, and a sidewall extending between the open proximal end and the open distal end; a flange extending through the interior of the housing between the open proximal end and the open distal end, the flange including one or more openings; a compressible absorbent material at least partially impregnated with a disinfecting fluid, wherein the compressible absorbent material is located distal to the flange; and a plunger connected to the housing to close the open distal end, the plunger being slidable relative to the housing between the open distal end and the open proximal end, Wherein movement of the plunger in the proximal direction compresses the compressible absorbent material and releases at least a portion of the disinfecting fluid through the one or more openings.

18. The disinfection cap according to claim 17, wherein: The flange includes a sealing surface configured to seal a cavity on the fluid path element.

19. The antiseptic cap of claim 18, further comprising a second compressible absorbent material located proximal to the flange and surrounding the sealing surface.

20. The disinfection cap of any one of claims 17 to 19, further comprising a gripping flange projecting radially outwardly from the housing.

21. The disinfection cap according to any one of claims 17 to 20, wherein: The plunger includes a collapsible fluid ball containing the antiseptic fluid, wherein the collapsible fluid ball can be collapsed by a pushing movement in a proximal direction to dispense the antiseptic fluid into the housing through one or more holes in the proximal end of the plunger.

22. The disinfection cap according to any one of claims 17 to 21, wherein: The inner surface of the sidewall includes one or more radially inwardly projecting protrusions configured to removably engage the fluid path element and retain the sterilization cap on the fluid path element.

23. The sterilization cap of any one of claims 17 to 22, wherein the absorbent material is a sponge.

24. The sterilization cap of any one of claims 17 to 22, wherein the absorbent material is cotton.

25. The disinfection cap according to any one of claims 17 to 24, wherein the disinfection solution comprises isopropyl alcohol, ethanol, a combination thereof, or an aqueous solution thereof.

26. The disinfection cap of any one of claims 17 to 25, further comprising a gripping flange projecting distally from the closed distal end.

27. The sterilization cap of any one of claims 17 to 26, further comprising a seal removably connected to the open proximal end.

28. The disinfection cap of claim 27, wherein the seal comprises a pull tab that projects radially outwardly relative to a side wall of the housing.

29. A sterilization cap for a fluid path element, the fluid path element having an inner cavity and an outer cylindrical wall surrounding the inner cavity, the sterilization cap comprising: a housing configured to receive the lumen and outer cylindrical wall of the fluid path element, the housing including an open proximal end, a closed distal end, and a sidewall extending between the open proximal end and the closed distal end to define an interior volume; a sleeve protruding proximally from an inner surface of the closed distal end, the sleeve defining an opening configured to receive the lumen of the fluid path element; and a compressible absorbent material at least partially impregnated with a disinfectant solution, the compressible absorbent material disposed within the interior volume of the housing and surrounding at least a portion of the exterior of the sleeve, wherein the outer cylindrical wall of the fluid path element is configured to be received in a sterile space between an 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 sterile fluid into the sterile space.

30. The disinfection cap of claim 29, wherein: The inner surface of the sleeve is configured to sealingly engage the inner cavity of the fluid path element.

31. The sterilization cap of claim 29 or claim 30, wherein the compressible absorbent material extends substantially from the closed distal end of the housing to the proximal end of the housing.

32. The disinfection cap according to any one of claims 29 to 31, wherein: The sleeve includes one or more radially outwardly projecting longitudinal ribs configured to engage the compressible absorbent material surrounding an exterior of the sleeve to prevent rotation of the compressible absorbent material relative to the sleeve.

33. The disinfection cap according to any one of claims 29 to 32, wherein: The compressible absorbent material has an axial groove configured to receive an outer cylindrical wall of the fluid path element.

34. The antiseptic cap of any one of claims 29 to 33, wherein the sleeve includes a tab configured to provide tactile or audible feedback when the lumen of the fluid path element is fully inserted into the sleeve.

35. The disinfection cap according to any one of claims 29 to 34, wherein: The inner surface of the sidewall includes one or more radially inwardly projecting protrusions configured to removably engage the outer cylindrical wall and retain the sterilization cap on the fluid path element.

36. The sterilization cap of any one of claims 29 to 35, wherein the absorbent material is a sponge.

37. The sterilization cap of any one of claims 29 to 35, wherein the absorbent material is cotton.

38. The disinfection cap of any one of claims 29 to 37, wherein the disinfection solution comprises isopropyl alcohol, ethanol, a combination thereof, or an aqueous solution thereof.

39. The disinfection cap of any one of claims 29 to 38, further comprising a gripping flange projecting distally from the closed distal end.

40. The sterilization cap of any one of claims 29 to 39, further comprising a seal removably connected to the open proximal end, wherein the seal fluidly seals the open proximal end.

41. The antiseptic cap of claim 40, wherein the seal includes a pull tab that projects radially outwardly relative to a sidewall of the housing, and wherein the pull tab is configured to remove the seal from the open proximal end.

42. A fluid path assembly comprising: a fluid path element having an inner cavity and an outer cylindrical wall surrounding the inner cavity; and a sterilization cap configured to be coupled to the fluid path element, the sterilization cap comprising: a housing configured to receive the lumen and outer cylindrical wall of the fluid path element, the housing including an open proximal end, a closed distal end, and a sidewall extending between the open proximal end and the closed distal end to define an interior volume; a sleeve protruding proximally from an inner surface of the closed distal end, the sleeve defining an opening configured to receive the lumen of the fluid path element; and a compressible absorbent material at least partially impregnated with a disinfectant solution, the compressible absorbent material disposed within the interior volume of the housing and surrounding at least a portion of the exterior of the sleeve, wherein the outer cylindrical wall of the fluid path element is configured to be received in a sterile space between an 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 sterile fluid into the sterile space.

43. The fluid path assembly of claim 42, wherein: The inner surface of the sleeve is configured to sealingly engage the inner cavity of the fluid path element.

44. A fluid path assembly according to claim 42 or 43, wherein: The compressible absorbent material extends from the closed distal end of the housing to the proximal end of the housing.

45. A fluid path assembly according to any one of claims 42 to 44, wherein: The sleeve includes one or more ribs projecting radially outwardly, the one or more ribs being configured to engage the compressible absorbent material to prevent rotation of the compressible absorbent material relative to the sleeve.

46. ​​A fluid path assembly according to any one of claims 42 to 45, wherein: The compressible absorbent material has an axial groove configured to receive an outer cylindrical wall of the fluid path element.

47. A fluid path assembly according to any one of claims 42 to 46, wherein: The sleeve includes a tab configured to provide tactile or audible feedback when the lumen of the fluid path element is fully inserted into the sleeve.

48. A fluid path assembly according to any one of claims 42 to 47, wherein: The inner surface of the sidewall includes one or more radially inwardly projecting protrusions configured to removably engage the fluid path element and retain the sterilization cap on the fluid path element.

49. A fluid path assembly according to any one of claims 42 to 48, wherein: The absorbent material is a sponge.

50. A fluid path assembly according to any one of claims 42 to 48, wherein: The absorbent material is cotton.

51. A fluid path assembly according to any one of claims 42 to 50, wherein: The disinfectant comprises isopropyl alcohol, ethanol, a combination thereof or an aqueous solution thereof.

52. The fluid path assembly of any one of claims 42 to 51 further comprising a gripping flange projecting distally from the closed distal end.

53. The fluid path assembly of any one of claims 42 to 52, further comprising a seal removably connected to the open proximal end, wherein the seal fluidly seals the open proximal end.

54. The fluid path assembly of claim 53, wherein the seal includes a pull tab that projects radially outwardly relative to a sidewall of the housing, and wherein the pull tab is configured to remove the seal from the open proximal end.

55. A fluid path assembly according to any one of claims 42 to 54, wherein: The fluid path element is a Luer connector.

56. A fluid path assembly according to any one of claims 42 to 55, wherein: The fluid path element is a multi-patient fluid path element.

57. A fluid path assembly according to any one of claims 42 to 55, wherein: The fluid path element is a single-patient fluid path element.

58. A fluid path assembly according to any one of claims 42 to 57, wherein: The fluid path element comprises: a first connector element comprising a body, a first cavity, a first flexible leg, and a second flexible leg; and a second connector element including a body defining an undercut, a second cavity, a channel defined in the body, and at least one sealing element positioned within the channel, wherein the first flexible leg comprises a first flange and the second flexible leg comprises a second flange, wherein, when the first connector element is engaged with the second connector element, the first flange and the second flange engage with the undercut of the body of the second connector element to prevent the first connector element and the second connector element from being disengaged, and Wherein the sealing element is configured to define a fluid tight seal between the second cavity of the second connector element and the first cavity of the first connector element to form a fluid path when the first connector element and the second connector element are engaged with each other.

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