Fluid connector assembly

Abstract

A fluid connector assembly is disclosed that seals the flow paths of each connector. When the connectors of the fluid connector assembly are connected to each other, the compressible members of each connector are displaced, allowing fluid to pass downstream through the fluid connector assembly. The connectors may be coupled via a coupling mechanism that provides a threshold holding force. When an external force greater than the threshold force is applied to the fluid connector assembly, the snap mechanism can no longer hold the connectors together and separates the connectors from each other.

Description

Technical Field

[0001] The present disclosure generally relates to medical fluid connectors, and more particularly to a fluid connector assembly including medical connectors that separate from each other by an applied force, where each medical connector is designed to automatically seal its respective flow path. The separation may be due to an intentional or unintentional disconnection between the medical connectors.

Background Art

[0002] Peripheral intravenous catheters ("PIVC") are medical devices inserted into a patient's peripheral vein to deliver medical fluids to the patient. In an exemplary use, a medical fluid is delivered to the patient, followed by a healthcare provider removing the PIVC catheter from the patient. However, these catheters are often inadvertently removed. For example, the catheter line may pull on the IV tube and remove the catheter from the patient by receiving an unintended or unexpected tensile force. In other instances, the catheter may be accidentally removed by the patient and healthcare provider. Unintended or unexpected removal may lead to potential patient blood loss, IV fluid loss, and delays in IV fluid delivery.

Summary of the Invention

Problems to be Solved by the Invention

[0003] According to at least some embodiments disclosed herein, it is recognized that an unintended removal or disconnection of a medical connection, such as a medical fluid line, can potentially result in harm to the patient or healthcare provider, such as depriving the patient of medication, increasing the patient's risk of infection, and exposing the healthcare provider to medication.

Means for Solving the Problems

[0004] Aspects of this disclosure provide fluid connector assemblies having medical connectors, each containing one or more fluid channels, that respond to unintentional or unexpected external forces by separating from each other and sealing each fluid channel. The separation may include automatic separation using bellows or other elastically compressible members that depressurize and return to their original shape when no external force is acting. Beneficially, the fluid connector assemblies described herein can limit or prevent patient blood loss, IV fluid loss, infection, and delays in medical delivery. Furthermore, aspects of this disclosure provide coupling mechanisms for assisting the coupling of fluid connector assemblies when they are separated.

[0005] According to a particular embodiment, the fluid connector assembly includes a first connector, a second connector, and a coupling mechanism. The second connector may be configured to couple with the first connector and may include a snap member disposed at one end thereof. The coupling mechanism may be coupled to the second connector to detachably couple the first and second connectors. The coupling mechanism may include a body having a passage extending through to provide fluid communication between the first and second connectors, and at least one projection extending from one end of the body. When the coupling mechanism is coupled to the second connector, at least a portion of the coupling mechanism may be positioned within an opening in the snap member and secured by the projection. Furthermore, the coupling mechanism may be made detachable from the second connector by acting on the snap member.

[0006] In some embodiments, the coupling mechanism remains coupled to the second connector by a threshold force, and an external force greater than the threshold force is applied to at least one of the first and second connectors, causing the coupling mechanism to separate from the second connector. The external force may be a tensile force of at least 2.27 kg (5 pounds).

[0007] In some embodiments, the snap member includes at least one snap arm extending from one end of the snap member, and by acting on the at least one snap arm, the coupling mechanism can be separated from the second connector.

[0008] In some embodiments, the coupling mechanism further includes a valve member disposed within the passage. When the first connector and the second connector are coupled, the valve member may be configured to allow fluid communication between the first connector and the second connector. When the first connector and the second connector are separated, the valve member may be configured to prevent the flow of fluid through the passage.

[0009] In some embodiments, the projection extends outward with respect to a central axis extending in the longitudinal direction, and the outer contour of the projection corresponds to the inner contour of the opening of the snap member.

[0010] In some embodiments, at least a portion of the coupling mechanism is coupled to the outer surface of the second connector. When a tensile force greater than a threshold force is applied to the second connector in the direction along the central longitudinal axis, the coupling mechanism can actuate a snapping member, thereby separating the first and second connectors, and when the first and second connectors are separated, at least a portion of the coupling mechanism remains coupled to the second connector.

[0011] In some embodiments, the fluid connector assembly is a closed-loop drug transfer device.

[0012] According to a particular embodiment, a method for coupling a fluid connector coupling assembly includes the steps of providing a first connector, a second connector configured to couple to the first connector, and a coupling mechanism configured to couple the first connector and the second connector. The second connector may include a snap member disposed at one end thereof. The coupling mechanism may include a body and at least one projection extending from one end of the body. The method may include the steps of coupling one end of the coupling mechanism to the second connector such that at least a portion of the coupling mechanism is disposed within an opening in the snap member, and coupling the first connector to the opposite end of the coupling mechanism such that the first connector, the second connector, and the coupling mechanism are in fluid communication.

[0013] In some embodiments, the step of connecting the end of the coupling mechanism to the second connector includes positioning the projection within the opening of the snap member such that the outer surface of at least one projection abuts against the inner surface of the snap member in a snap-fit ​​configuration. Furthermore, separating the coupling mechanism from the second connector may include acting the snap member to create a gap between at least one projection and the inner surface, thereby allowing the coupling mechanism to be removed from the opening.

[0014] In some embodiments, the coupling mechanism remains coupled to the second connector by a threshold force, and when an external force greater than the threshold force is applied to at least one of the first and second connectors, the coupling mechanism is separated from the second connector.

[0015] In some embodiments, the coupling mechanism further comprises a valve member disposed within a passage formed within the body of the coupling mechanism. When the first connector and the second connector are coupled, the valve member may be configured to allow fluid communication between the first connector and the second connector. When the first connector and the second connector are separated, the valve member may be configured to prevent the flow of fluid through the passage.

[0016] According to a particular embodiment, a fluid connector assembly includes a first connector, a second connector configured to couple to the first connector, and a coupling mechanism for detachably coupling the first and second connectors. The second connector may be a closed system having a snap member disposed with at least one arm protruding from one end of the snap member. The coupling mechanism may include a body having a passage extending through to provide fluid communication between the first and second connectors, a valve member disposed within the passage to control the flow of fluid through the passage, a first projection extending from a first end of the body for coupling to the first connector, and a second projection extending from a second end of the body for coupling to the second connector. When the coupling mechanism is coupled to the second connector, at least a portion of the coupling mechanism may be positioned within an opening in the snap member and secured by the second projection. If the separating force exceeds a predetermined threshold, the coupling mechanism may be separated from the second connector.

[0017] In some embodiments, the predetermined threshold is a tensile force of at least 2.27 kg (5 pounds).

[0018] In some embodiments, the arm includes a first snap arm protruding from a first side of the second connector and a second snap arm protruding from a second side of the second connector opposite to the first side. Furthermore, the coupling mechanism may be separated from the second connector by acting on the first and second snap arms.

[0019] In some embodiments, when the first connector and the second connector are coupled, the valve member is configured to allow fluid communication between the first connector and the second connector, and when the first connector and the second connector are separated, the valve member is configured to prevent fluid flow through the passage.

[0020] In some embodiments, each of the first protrusion and the second protrusion extends outwardly with respect to a central axis extending in the longitudinal direction of the connecting mechanism. Further, the outer surface contour of the second protrusion may correspond to the inner contour of the opening of the snap member.

[0021] In some embodiments, the connecting mechanism includes a ring member that is slidably disposed on the outer surface of the second connector and configured to actuate the snap member. Further, when the breaking force exceeds a predetermined threshold value, the ring member may slide along the second connector until the ring member is disposed on at least one arm, thereby actuating the snap member.

[0022] Various features of illustrative embodiments of the present invention are described below with reference to the drawings. The illustrated embodiments are intended to illustrate, but not limit, the present invention. The drawings include the following figures.

Brief Description of the Drawings

[0023] [Figure 1] A diagram illustrating an IV set coupled to a patient according to an aspect of the present disclosure. [Figure 2] A partial cross-sectional view of a connector of a fluid connector assembly according to an aspect of the present disclosure. [Figure 3A] A partial cross-sectional view of a connector of a fluid connector assembly according to an aspect of the present disclosure. [Figure 3B] A partial cross-sectional view of a connector of a fluid connector assembly according to an aspect of the present disclosure. [Figure 4] A partial cross-sectional view of a fluid connector assembly according to an aspect of the present disclosure. [Figure 5A] A partial cross-sectional view of a connecting mechanism of a fluid connector assembly according to an aspect of the present disclosure. [Figure 5B] A partial cross-sectional view of a connecting mechanism of a fluid connector assembly according to an aspect of the present disclosure. [Figure 5C] A partial cross-sectional view of a connecting mechanism of a fluid connector assembly according to an aspect of the present disclosure. [Figure 6] A partial cross-sectional view of a fluid connector assembly, according to an aspect of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the subject technology. It will be understood that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.

[0025] Furthermore, while this specification describes specific details of various embodiments, the description is illustrative only and should not be construed as limiting in any way. Additionally, while specific embodiments of the present disclosure may be disclosed or shown in the context of an IV set, it is contemplated that such embodiments may be used in other fluid conveyance systems. Moreover, various uses of such embodiments and modifications thereof that may occur to those skilled in the art are also subsumed by the general concepts described herein.

[0026] According to several embodiments, the present disclosure includes various features and advantages of fluid connector assemblies having medical connectors that seal their respective flow paths when the medical connectors are separated from each other, such as closed-system drug transfer devices (CSTDs). In addition, the fluid connector assembly may be formed to prevent the transfer of environmental contaminants into the system and to prevent the leakage of hazardous drugs or vapor concentrations from the device. Each medical connector may include a compressible member that depressurizes in response to separation, thereby resulting in the automatic sealing of its respective flow path. The fluid connector assembly may further include a coupling mechanism to also connect the components of the fluid connector assembly while maintaining the closed system of the assembly. Furthermore, the coupling mechanism may be configured to detach from the connectors of the fluid connector assembly when a threshold tensile force is reached, while maintaining the closed system by preventing environmental contaminants from entering the system and preventing the leakage of any contained drugs or vapors.

[0027] Referring here to the figures, Figure 1 illustrates an IV set 1 coupled to a patient 10 according to an aspect of the present disclosure. The IV set 1 includes a drug bag 12, a drip chamber 14, and a tube 22. The tube 22 extends between the drip chamber 14 and the fluid connector assembly 100 of the IV set 1. To prevent unintended removal or detachment of the tube 16 or catheter 18 from the patient, a tape 26 is placed over the tube 16 and catheter 18, thereby engaging the tube 16, catheter 18, and patient 10.

[0028] Figure 2 illustrates a perspective view of a fluid connector assembly 100 according to an aspect of the present disclosure. The fluid connector assembly 100 is designed for use in medical applications, such as IV Set 1 (shown in Figure 1) and other IV medical fluid delivery applications using catheters, including a PIVC catheter.

[0029] As shown, the fluid connector assembly 100 includes a connector 102 and a connector 104 coupled to connector 102. Connectors 102 and 104 may be referred to as the first connector and the second connector, respectively, although "first" and "second" may be interchangeable. Connectors 102 and 104 may also be referred to as medical connectors. When connectors 102 and 104 are connected to each other as shown in Figure 2, a flow path for medical fluid is established by the fluid connector assembly 100.

[0030] In some embodiments, connector 104 is connected to a medical fluid (not shown). Furthermore, in some embodiments, connector 102 is connected to a catheter line (not shown) that delivers the medical fluid to a catheter. In this regard, connector 104 may include a fluid inlet 106 that acts as a fluid receiving point for the fluid connector assembly 100. Also, connector 102 may include a fluid outlet 108 that acts as a fluid delivery point for the fluid connector assembly 100.

[0031] To facilitate connection to medical fluids, connector 104 may include a luer. In some embodiments, the luer is a female luer designed to mate with a male connector connected to a medical fluid. Similarly, to facilitate connection to a catheter line, connector 102 may include a luer. In some embodiments, the luer is a male luer designed to mate with a female connector connected to a catheter line. Each luer may conform to standards established by the International Organization for Standardization ("ISO") to improve patient safety, minimize leakage of medical fluids, and reduce misconnection with other connecting devices.

[0032] In addition, the connector 102 may include a post 112 that passes through the connector 102 through its center or at least approximately its center. The post 112 may include a passage 114 that establishes a fluid outlet 108. Although the post 112 is shown as cylindrical, it is not limited to that and may have any preferred shape.

[0033] The connector 102 may include a housing integrated with a lure. The connector 102 may include a first end 102A having an integrated lure, and a second end 102B located opposite the first end 102A and configured to connect to the receiving ring 110. The second end 102B has a stepped contour with a protruding portion having a thickness reduced relative to the thickness of the rest of the housing.

[0034] The connector 102 may include an outer surface 102C and an inner surface 102D. The connector 102 may include a hollow or substantially hollow body that carries one or more components. For example, in addition to the post 112, a compressible member 116 may be housed within the connector 102. The connector 102 may further include a wall 120 that extends laterally across the interior of the connector 102, thereby dividing the interior of the connector 102 into separate cavities 122, 124. The post 112 may be formed integrally with the wall 120 and may extend through each of the cavities 122, 124. The post 112 may include an open first end 120A, a closed second end 120B opposite the first end 120A, and a passage 114 extending through the post 112. The first end 120A may include an opening for the passage 114 that forms a fluid outlet 108. The second end 120B of post 112 may be a substantially closed end and may include one or more apertures 128, also referred to as flow windows.

[0035] The connector 102 may further include a receiving ring 110 disposed at and coupled to a second end 102B of the connector 102. The receiving ring 110 may include a first end 110A configured to coupled to the second end 102B, and a second end 110B on the opposite side of the first end 110A. The first end 110A of the receiving ring 110 may have a stepped contour with a projection 130 that complements the projection of the connector 102. The second end 110B of the receiving ring 110 may include an opening 132. The receiving ring 110 may have an outer surface 110C and an inner surface 110D. The receiving ring 110 may include one or more notches 144 formed along the outer surface 110C.

[0036] As described above, the connector 102 may include a compressible member 116 disposed inside the connector 102, also referred to as a silicone valve. The compressible member 116 may be disposed within the cavity 124 and may extend through the receiving ring 110. The compressible member 116 has a first end 116A positioned proximal to the surface of the wall 120 and a second end 116B positioned within the opening 132 of the receiving ring 110 and configured to engage with the components of the connector 104. The second end 116B may include an engaging surface 134. The engaging surface 134 may provide a planar or substantially planar surface that can be easily accessed for cleaning and disinfection. The engaging surface 134 may further include an opening 136. In some embodiments, the opening 136 may be formed as one or more slits or apertures. The post 112 may extend through the compressible member 116. In other words, the compressible member 116 may extend around the outer surface of the post 112. The second end 112B of the post 112 may be positioned within a region formed proximal to the second end 112B of the compressible member 116.

[0037] In some embodiments, the compressible member 116 includes an elastically compressible bellows. Thus, the compressible member 116 can be compressed by an external force and then return to its original incompressible form when the external force is removed. The compressible member 116 may be designed to regulate the fluid flow through the connector 102.

[0038] As shown in Figure 2, the connector 104 may be a CSTD having a first end 104A configured to engage with the connector 102 when coupled, and a second end 104B on the opposite side of the first end 104A. The connector 104 may include an outer surface 104C and an inner surface 104D. The connector may include a passage 138 extending through the interior of the connector 104. The connector 104 may further include a spring member 166 disposed inside the connector 104.

[0039] In some embodiments, the connector 104 may further include a connector interface 140 coupled to a second end 104B of the connector 104. The connector interface 140 may include a first end 140A configured to couple with the connector 104, and a second end 140B on the opposite side of the first end 140A. The connector interface 140 may be fixedly coupled to the second end 104B of the connector 104 by any preferred means to prevent the closed state of the connector 104 from being preserved. For example, the connector interface 140 may be screwed onto the second end 104B. The connector interface 140 may include a passage 142 extending through the connector interface 140 and providing a path for the needle 20. In some embodiments, the connector interface 140 may provide a passage 142 that prevents needle exposure and accidental needle sticks by allowing the needle 20 to be completely enclosed. The connector interface 140 may include an outer surface 140C and an inner surface 140D. The outer surface 140C may further include one or more projections 146 extending radially from the outer surface 140C.

[0040] The connector 104 may further include a snap member 148, also referred to as a snap release. The snap member 148 may be disposed at a first end 104A of the connector 104. The snap member 148 may include a first end 148A, a second end 148B opposite to the first end, an outer surface 148C, and an inner surface 148D. The snap member 148 may include a plurality of snap arms 150 positioned on the outer surface 148C of the snap member 148. In some embodiments, the snap arms 150 may be integrally formed with the snap member 148. In other embodiments, the snap arms 150 may be formed separately from the body of the snap member 148 and may be coupled via any preferred means. The snap arms 150 may include a first end 150A coupled to or integrally formed with the body of the snap member, and a second end 150B opposite to the first end 150A. The second end 150B may be positioned proximal to but separated from the outer surface 104C of the connector 104 so that a gap 152 is formed between the inner surface of the snap arm 150 and the outer surface 104C of the connector 104. The snap arm 150 may be flexible so that when separating the fluid connector assembly 100, the second end 150B can bend inward relative to the outer surface 104C, thereby reducing the size of the gap 152. The first end 148A of the snap arm may include an opening 156 for receiving coupling mechanisms 200, 300, 400, 500. The opening 156 may include a side portion 158 that forms the outer circumference of the opening 156. The side portion 158 may be shaped and sized to correspond to a portion of the coupling mechanisms 200, 300, 400, 500. Furthermore, the side portion 158 may be formed with a contour having one or more notches or recesses for receiving the coupling mechanisms 200, 300, 400, 500, which will be described in more detail below.

[0041] The connector 104 may include a valve assembly 160 coupled to the first end 104A of the connector 104. The valve assembly 160 may include a compartment 162 having one or more compressible members 164 disposed within the compartment 162, also referred to as an elastomer plug. The valve assembly 160 may be sized and shaped to completely occupy the opening formed in the first end 104A of the connector 104. In some embodiments, the valve assembly 160 is formed integrally with the connector 104. In other embodiments, the valve assembly 160 is formed separately from the connector 104 and coupled to the connector 104 by any preferred means to maintain a closed system. For example, the valve assembly 160 may be screwed. The valve assembly 160 may be coupled at the opposing ends of a snap member 148. In some embodiments, the valve assembly 160 is substantially housed within the snap member 148.

[0042] As described above, the valve assembly 160 may include one or more compressible members 164. In some embodiments, the valve assembly 160 may include a first compressible member 164A and a second compressible member 164B housed within an internal cavity of compartment 162. The first compressible member 164A may be positioned proximal to the snap member 148, and the second compressible member 164B may be positioned opposite the first compressible member 164A. Fluid flowing through the fluid inlet 106 may pass through the compressible members 164A, 164B via apertures formed within them. Furthermore, as shown in Figure 2, the compressible members 164A, 164B may be configured to allow a needle 20 to pass through the valve assembly 160 to provide drug delivery through the connector 104. In some embodiments, each of the compressible members 164A, 164B includes an elastically compressible bellows. Therefore, the compressible members 164A and 164B can be compressed by an external force and then return to their original incompressible form when the external force is removed. The compressible members 164A and 164B are designed to regulate the fluid flow through the connector 104.

[0043] Based on the positions of the compressible members 164A and 164B shown in Figure 2, the connector 104 can prevent fluid from flowing through it. In other words, fluid entering through the fluid inlet 106 can be prevented from passing through due to the position and expansion state of the compressible members 164A and 164B.

[0044] To facilitate the passage of fluid through connectors 102 and 104, when the fluid connector assembly 100 is assembled, each compressible member 116, 164A, and 164B may be actuated or displaced to expose the respective openings of connectors 102 and 104.

[0045] In some embodiments, a fluid containing medical fluid may pass through the fluid connector assembly 100 downstream from connector 104 to connector 102 within a closed system. The fluid may enter the fluid inlet 106 and then pass through compressible members 164A and 164B. The fluid may then pass through the opening 128 of post 112 and then through the passage 126 of post 112. The fluid may exit the fluid connector assembly 100 through the fluid outlet 108.

[0046] As described above, separation of connector 102 and connector 104 may result from an external force applied to one or both of connector 102 and connector 104, where the external force exceeds the threshold force required to maintain the connection between connector 102 and connector 104.

[0047] When connectors 102 and 104 are separated, the forces applied to the compressible members 116 and 164 of connectors 102 and 104, respectively, may be removed so that the compressible members 116 and 164 can be depressurized and expanded so that they return to their original shapes. For example, during the expansion of compressible member 116, the second end 116B of compressible member 116 may move toward the second end 110B of the receiving ring 110 until the compressible member 116 returns to its original shape such that the second end 116B is positioned within the opening 132 of the receiving ring 110. Similarly, during the expansion of compressible member 164, the first end 160A may move toward the first end 104A until the compressible member 164 returns to its original shape such that the first end is positioned within the opening of connector 104. As a result, it may be impossible for the fluid to flow upstream through the connector 102 and to pass through the opening formed in the post 112.

[0048] Each of the compressible members 116 and 164 can be used as a valve to regulate the fluid flowing through the fluid connector assembly 100. Based on the elastic spring-like properties of these compressible members, each of the compressible members 116 and 164 may automatically return to their respective shapes when no external force is acting on them. Beneficially, the compressible members 116 and 164 may spring back in response to separation between connector 102 and connector 104 to provide a relatively rapid sealing effect. Thus, when the fluid connector assembly 100 is integrated with an IV set and catheter, based on one or more properties of the compressible members 116 and 164, blood loss, IV fluid loss, and delays in medical delivery can be limited or prevented.

[0049] In some embodiments, the fluid connector assembly 100 may further include coupling mechanisms 200, 300, 400, and 500 for connecting connectors 102 and 104.

[0050] Referring to Figure 3, the coupling mechanism 200 may include a body 202 consisting of two halves 204 and 206, also referred to as a first side and a second side, respectively. Each of the first side 204 and the second side 206 may include a first end 204A and 206B, respectively, and a second end 204B and 206B, respectively, opposite to the first end 204A and 206B. The body 202 may further include a passage 208 extending through the body 202 to provide fluid communication between connector 102 and connector 104. The coupling mechanism 200 may include a valve 210, also referred to as a plug member, disposed within the passage 208. The valve 210 may regulate the flow of fluid through the passage 208. For example, when connectors 102 and 104 are coupled, the valve 210 may allow fluid flow through the passage 208. Conversely, when the connectors 102 and 104 are not coupled, the valve 210 may prevent the flow of fluid through the passage 208. The coupling mechanism 200 may further comprise one or more projections 212 and 214. In some embodiments, each of the first side 204 and the second side 206 includes a first projection 212 disposed at the first ends 204A and 206A, and a second projection 214 disposed at the second ends 204B and 206B. The first projection 212 may be configured to couple with the connector 102. The first projection 212 may include an inwardly extending portion that protrudes toward the central axis extending longitudinally of the coupling mechanism 200. The inwardly extending portion of the first projection 212 may be sized and shaped to correspond with the notch 144 of the receiving ring in order to couple the coupling mechanism 200 with the connector 104. The second projection 214 may include an outwardly extending portion that protrudes away from the central axis extending in the longitudinal direction of the connecting mechanism 200. The outwardly extending portion may be sized and shaped to correspond to the side portion 158 of the snap member 148.

[0051] To separate the coupling mechanism 200 from the connector 104, the user can actuate the snap arm 150 by applying a pressing force to it, thereby creating a gap between the second projection 214 and the inside of the side portion 158 of the snap member 148. When sufficient gap is provided, the user can remove the coupling mechanism 200 from the connector 102.

[0052] Referring to Figure 4, the fluid connection assembly may include a coupling mechanism 300. Similar to the coupling mechanism 200 described above, the coupling mechanism 300 may include a body 302 having two halves, also referred to as a first side 304 and a second side 306. Each of the first side 304 and the second side 306 may include a first end 304A, 306B and a second end 304B, 306B opposite the first end 304A, 306B, respectively. The body 302 may further include a passage 308 extending through the body 302 to provide fluid communication between connector 102 and connector 104. The coupling mechanism 300 may include a valve 310, also referred to as a one-way valve, disposed within the passage 308. The valve 310 may regulate the flow of fluid through the passage 308. For example, when connectors 102 and 104 are coupled, the valve 310 may allow fluid to flow through the passage 308. Conversely, when connectors 102 and 104 are not coupled, the valve 310 may prevent fluid from flowing through the passage 308. The coupling mechanism 300 may further comprise one or more projections 312 and 314. In some embodiments, each of the first side 304 and the second side 306 includes a first projection 312 disposed at the first ends 304A and 306A, and a second projection 314 disposed at the second ends 304B and 306B. The first projection 312 may be configured to couple with the connector 102. The first projection 312 may include an outward-extending portion projecting toward the central axis extending longitudinally of the coupling mechanism 300. The first projection 312 may be sized and shaped to correspond to the opening 132 of the receiving ring 110. When the coupling mechanism 300 is coupled to the connector 102, one end of the first projection 312 may be in contact with the compressible member 116. The first projection may assist in compressing the compressible member 116 to allow fluid flow. The second projection 314 may include an outward-extending portion that protrudes away from the central axis extending in the longitudinal direction of the coupling mechanism 300. The outward-extending portion may be sized and shaped to correspond to the side portion 158 of the snap member 148.

[0053] As described above with respect to the coupling mechanism 200, in order to separate the coupling mechanism 300 from the connector 104, the user can actuate the snap arm 150 by applying a pressing force to the snap arm 150, thereby creating a sufficient gap between the second projection 314 and the inside of the side portion 158 of the snap member 148.

[0054] Referring to Figures 5A to 5C, the coupling mechanism 400 may include a body 402 disposed on the outer surface 104C of the connector 104. The coupling mechanism 400 may include a first end 402A disposed near the snap member 148 and a second end 402B located opposite the first end 402A and disposed near the connector interface 140. The first end 402A may include a ring 404 surrounding at least a portion of the snap arm 150. The ring 404 may be sized such that only a small gap exists between the inner surface of the ring 404 and the outer surface of the snap arm 150. The second end 402B may include a bond pocket 406 that surrounds the connector interface 140. The bond pocket 406 may be coupled to the tube 22 of the IV set 1. The bond pocket 406 may be coupled by any preferred means, including but not limited to adhesive. The main body 402 may further include one or more notches or retaining elements 408 for further securing the coupling mechanism 400 to the connector 104 by engaging with projections 146 of the connector interface 140. In some embodiments, a substantial portion of the connector 104 is not surrounded by the coupling mechanism 400. The coupling mechanism 400 may be configured to slide along the connector 104 for a specific distance.

[0055] The coupling mechanism 400 may work in cooperation with the coupling mechanism 300. During assembly, the coupling mechanism 400 is fixed to the connector 104 with the ring 404 positioned near the first end 148A of the snap member 148. Meanwhile, the coupling mechanism 300 may be coupled to the connectors 102 and 104 as described above, thereby providing fluid communication between the connectors 102 and 104. When the pipe 22 is pulled with sufficient force away from the second end 104B of the connector 104, the coupling mechanism 400 may slide against the connector 104. Specifically, the ring 404 may slide from the first end 150A to the second end 150B in a direction along the snap arm 150. Since the snap arm 150 is inclined away from the central longitudinal axis of the connector 104, the ring 404 may slide until its inner surface contacts the outer surface of the snap arm 150 and friction prevents further movement. When the ring 404 reaches this stopping point, which may be near the second end 150B, the pressure exerted by the ring 404 may push the snap arm 150 inward, thereby separating the coupling mechanism 300 from the opening 156 of the snap member 148.

[0056] If the user wishes to intentionally separate the coupling mechanism 300 from the connector 104, the user may perform the steps described above with respect to the coupling mechanisms 200 and 300. In other words, the user may actuate the snap arm 150 by applying a pressing force to the snap arm 150, thereby creating sufficient clearance between the second projection 314 and the interior of the side portion 158 of the snap member 148. Alternatively, the user may pull the coupling mechanism 400 from a position proximal to the second end 402B until the ring 404 provides the snap arm 150 with sufficient force to separate the coupling mechanism 300.

[0057] Referring to Figure 6, the coupling mechanism 500 may include a body 502 having a first end 502A configured to couple with the connector 102, and a second end 502B located opposite the first end 502A and configured to couple with the connector 104. The body 502 may further include a passage 504 extending through the body 502 to provide fluid communication between the connector 102 and the connector 104. The passage 504 may include a front section 506 for housing a valve 508, also referred to as a plug member, disposed within the front section 506. As described above with respect to the coupling mechanism 200, the valve 508 may regulate the flow of fluid through the passage 504. The coupling mechanism 500 may further include a projection 510 disposed on the second end 502B. The projection 510 may be formed as a male luer and may be configured to contact and couple with the connector 102. When the coupling mechanism 500 is coupled to the connector 102, one end of the projection 510 may be in contact with the compressible member 116. The first projection may assist in compressing the compressible member 116 to allow fluid flow. The front portion 506 may be sized and shaped to be received within the opening 156 of the snap member 148.

[0058] The coupling mechanism 500 may be separated in the same manner as described above with respect to the coupling mechanisms 200, 300, and 400. In other words, the user may apply pressing force to the snap arm 150 to create sufficient clearance to remove the coupling mechanism 500 from within the snap member.

[0059] During use, the connecting mechanisms 200, 300, 400, and 500 and the connector 104 may remain connected until a separating force acts upon them. The separating force may be exerted by pulling the connector 102 away from the connector 104 and the connecting mechanisms 200, 300, 400, and 500, or by pulling the connector 104 and the connecting mechanisms 200, 300, 400, and 500 away from the connector 102. The separating force may act along the central axis of the connectors 102, 104 and the connecting mechanisms 200, 300, 400, and 500 while they are connected. The separating force may be the resultant force acting along the central axis of the connectors 102, 104 and the connecting mechanisms 200, 300, 400, 500 between them, or it may be a force acting on the connectors 102, 104, a force acting on the connecting mechanisms 200, 300, 400, 500, a force acting on the first part or the pipe, or a force acting on the second part of the pipe.

[0060] The separation force may separate the connecting mechanisms 200, 300, 400, and 500 from the connector 104 if the separation force exceeds a predetermined threshold force. For example, if the separation force is less than the predetermined threshold force, the connecting mechanisms 200, 300, 400, and 500 do not need to be separated from the connector 104. The predetermined threshold force prevents unintentional or accidental isolation based on small forces or movements. When connectors 102 and 104 are unintentionally separated, the connecting mechanisms 200, 300, and 500 may remain connected to the connector 102.

[0061] In some embodiments, the predetermined threshold force is approximately 2.27 kg (5 pounds). The predetermined threshold force may be approximately 0.45 kg (1 pound) to approximately 3.63 kg (8 pounds), approximately 1.36 kg (3 pounds) to approximately 3.18 kg (7 pounds), approximately 1.81 kg (4 pounds) to approximately 2.72 kg (6 pounds), or greater than 3.63 kg (8 pounds).

[0062] A feature of this disclosure is the provision of a first compressible member and a second compressible member that can be used as valves for adjusting the flow path between the first and second compressible members. The first and second compressible members are located in a first connector and a second connector, respectively. If the first and second connectors are separated, whether unintentionally or intentionally, the flow paths to the first and second compressible members are closed or blocked to prevent fluid loss from the flow paths. A feature of this disclosure is also the provision that, upon separation of the first and second compressible members, either the first or second compressible member can be cleaned and disinfected, and the first and second compressible members can be reconnected together to form a flow path between them.

[0063] Example of subject technology as a clause The subject art is illustrated, for example, in various embodiments as described below. Various examples of embodiments of the subject art are described as clauses numbered for convenience (1, 2, 3, etc.). These are provided as examples and do not limit the subject art. Note that any of the dependent clauses may be combined in any combination and may be placed in each of the independent clauses, for example, Clause 1, Clause 11, Clause 17, Clause 23, Clause 26, or Clause 29. Other clauses may be presented in the same manner.

[0064] Clause 1. A fluid connector assembly comprising: a first connector; a second connector configured to couple with the first connector, the second connector having a snap member disposed at one end of the second connector; and a coupling mechanism coupled to the second connector for detachably coupling the first connector and the second connector, the coupling mechanism comprising: a body having a passage extending through to provide fluid communication between the first connector and the second connector; and at least one projection extending from one end of the body, wherein when the coupling mechanism is coupled to the second connector, at least a portion of the coupling mechanism is positioned within an opening in the snap member and secured by at least one projection, and the coupling mechanism can be detached from the second connector by acting on the snap member.

[0065] Clause 2. The fluid connector assembly described above, wherein the coupling mechanism remains coupled to the second connector by a threshold force, and when an external force greater than the threshold force is applied to at least one of the first and second connectors, the coupling mechanism is separated from the second connector.

[0066] Clause 3. A fluid connector assembly as described above, wherein the external force is a tensile force of at least 2.27 kg (5 lbs).

[0067] Clause 4. The fluid connector assembly described above, wherein the snap member includes at least one snap arm extending from one end of the snap member, and by acting the at least one snap arm, the coupling mechanism can be separated from the second connector.

[0068] Clause 5. The fluid connector assembly described above, wherein the coupling mechanism further comprises a valve member disposed within a passage, wherein when the first connector and the second connector are coupled, the valve member is configured to allow fluid communication between the first connector and the second connector, and when the first connector and the second connector are separated, the valve member is configured to prevent the flow of fluid through the passage.

[0069] Clause 6. The fluid connector assembly described above, wherein at least one projection extends outward with respect to a longitudinally extending central axis, and the outer contour of at least one projection corresponds to the inner contour of the opening of the snap member.

[0070] Clause 7. The fluid connector assembly described above, wherein at least a portion of the coupling mechanism is coupled to the outer surface of the second connector, and when a tensile force greater than a threshold force is applied to the second connector in a direction along the central longitudinal axis, the coupling mechanism acts on a snapping member, thereby separating the first connector from the second connector, and when the first connector from the second connector is separated, at least a portion of the coupling mechanism remains coupled to the second connector.

[0071] Clause 8. A fluid connector assembly as described above, wherein the fluid connector assembly is a closed drug transfer device and includes at least one projection: a first projection extending from a first end of the body of the coupling mechanism for coupling to a first connector, and a second projection extending from a second end of the body of the coupling mechanism for coupling to a second connector. Clause 9. A method for coupling a fluid connector assembly,

[0072] A method comprising: providing a first connector; providing a second connector configured to couple with the first connector, wherein the second connector has a snap member disposed at one end of the second connector; providing a coupling mechanism configured to couple the first connector and the second connector, wherein the coupling mechanism comprises a body and at least one projection extending from one end of the body; coupling one end of the coupling mechanism to the second connector such that at least a portion of the coupling mechanism is disposed within an opening of the snap member; and coupling the first connector to the opposite end of the coupling mechanism such that the first connector, the second connector, and the coupling mechanism are in fluid communication.

[0073] Clause 10. The method described above, wherein the step of connecting the end of the coupling mechanism to a second connector includes positioning at least one projection within an opening of a snap member such that the outer surface of at least one projection abuts against the inner surface of the snap member in a snap-fit ​​configuration.

[0074] Clause 11. The method described above for separating the coupling mechanism from the second connector, comprising acting a snap member such that a gap is created between at least one projection and the inner surface, thereby allowing the coupling mechanism to be removed from the opening.

[0075] Clause 12. The coupling mechanism remains coupled to the second connector by a threshold force, and when an external force greater than the threshold force is applied to at least one of the first and second connectors, the coupling mechanism is separated from the second connector, as described above.

[0076] Clause 13. The method described above, wherein the coupling mechanism further comprises a valve member disposed in a passage formed within the body of the coupling mechanism, wherein when the first connector and the second connector are coupled, the valve member is configured to enable fluid communication between the first connector and the second connector, and when the first connector and the second connector are separated, the valve member is configured to prevent the flow of fluid through the passage.

[0077] Clause 14. A fluid connector assembly comprising: a first connector; a second connector configured to couple with the first connector, the second connector comprising a snap member disposed having at least one arm protruding from one end of the snap member, forming a closed system; and a coupling mechanism for detachably coupling the first connector and the second connector, comprising: a body having a passage extending through to provide fluid communication between the first connector and the second connector; a valve member disposed in the passage to control the flow of fluid through the passage; a first projection extending from a first end of the body for coupling with the first connector; and a second projection extending from a second end of the body for coupling with the second connector, wherein when the coupling mechanism is coupled to the second connector, at least a portion of the coupling mechanism is positioned within an opening in the snap member and secured by the second projection, and the coupling mechanism is separated from the second connector if the separating force exceeds a predetermined threshold.

[0078] Clause 15. A fluid connector assembly as described above, wherein the specified threshold is a tensile force of at least 2.27 kg (5 lbs).

[0079] Clause 16. A fluid connector assembly as described above, comprising at least one arm, a first snap arm protruding from a first side of the second connector and a second snap arm protruding from a second side of the second connector opposite to the first side, wherein the coupling mechanism can be separated from the second connector by acting the first and second snap arms.

[0080] Clause 17. A fluid connector assembly as described above, wherein when the first connector and the second connector are coupled, the valve member is configured to allow fluid communication between the first connector and the second connector, and when the first connector and the second connector are separated, the valve member is configured to prevent the flow of fluid through the passage.

[0081] Clause 18. The fluid connector assembly described above, wherein each of the first and second projections extends outward with respect to a central axis extending in the longitudinal direction of the coupling mechanism, and the outer contour of the second projection corresponds to the inner contour of the opening of the snap member.

[0082] Clause 19. A fluid connector assembly as described above, including a ring member, wherein the coupling mechanism is slidably disposed on the outer surface of a second connector and configured to actuate a snap member.

[0083] Clause 20. If the separating force exceeds a predetermined threshold, the ring member slides along the second connector until the ring member is positioned on at least one arm, thereby activating the snap member, as described above in the fluid connector assembly.

[0084] Further consideration In some embodiments, any provision of this specification may depend on any one provision of the independent provisions or any one provision of the dependent provisions. In one embodiment, any provision (e.g., a dependent provision or an independent provision) may be combined with any one or more other provisions (e.g., dependent provisions or independent provisions). In one embodiment, a claim may include some or all of the words (e.g., steps, actions, means, or components) that are contained in a provision, sentence, phrase, or paragraph. In one embodiment, a claim may include some or all of the words that are contained in one or more provisions, sentences, phrases, or paragraphs. In one embodiment, some of the words in each provision, sentence, phrase, or paragraph may be removed. In one embodiment, additional words or elements may be added to a provision, sentence, phrase, or paragraph. In one embodiment, the subject art may be implemented without using any of the components, elements, functions, or actions described herein. In one embodiment, the subject art may be implemented using additional components, elements, functions, or actions.

[0085] This disclosure is provided to enable those skilled in the art to practice the various embodiments described herein. This disclosure provides various examples of the subject art, and the subject art is not limited to these examples. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments.

[0086] Referencing a singular element is not intended to mean "one and only one" unless specifically stated, but rather "one or more." Unless specifically stated otherwise, the term "some" means one or more. Masculine pronouns (e.g., his) include feminine and neuter forms (e.g., her and its), and vice versa. Headings and subheadings, where present, are for convenience only and do not limit the invention.

[0087] The word “exemplary” is used herein to mean “serving as an example or illustration.” Any embodiment or design described herein as “exemplary” shall not necessarily be construed as preferable or advantageous to other embodiments or designs. In one embodiment, various alternative configurations and operations described herein may be considered at least equivalent.

[0088] Phrases such as "aspect" do not imply that such an aspect is essential to the subject art or that such an aspect applies to all configurations of the subject art. Disclosure relating to one aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. Phrases such as "aspect" may refer to one or more aspects, and vice versa. Phrases such as "embodiment" do not imply that such an embodiment is essential to the subject art or that such an embodiment applies to all configurations of the subject art. Disclosure relating to one embodiment may apply to all embodiments, or to one or more embodiments. An embodiment may provide one or more examples. Phrases such as "embodiment" may refer to one or more embodiments, and vice versa. Phrases such as "configuration" do not imply that such a configuration is essential to the subject art or that such a configuration applies to all configurations of the subject art. Disclosure relating to one configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase like "a composition" can refer to one or more compositions, and vice versa.

[0089] In one embodiment, unless otherwise specified, all measurements, values, evaluations, locations, scales, sizes, and other specifications described herein, including in the following claims, are approximate and not precise. In one embodiment, they are intended to be within a reasonable range that is not inconsistent with the functions to which they relate and with the conventions of the art to which they relate.

[0090] In one aspect, terms such as "coupled" may refer to direct coupling. In another aspect, terms such as "coupled" may refer to indirect coupling.

[0091] As used in this disclosure, terms such as “top,” “bottom,” “front,” and “rear” should be understood to refer to an arbitrary coordinate system rather than the usual gravitational coordinate system. Thus, the top, bottom, front, and rear surfaces may extend upward, downward, obliquely, or horizontally in the gravitational coordinate system.

[0092] Various items may be arranged differently (for example, in different orders or categorized in different ways) without all deviating from the scope of the subject art. All structural and functional equivalents to various aspects of elements known to those skilled in the art, or to be subsequently known to those skilled in the art, as described through this disclosure, are expressly incorporated herein by reference and intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be dedicated to the public, whether or not such disclosures are expressly stated in the claims. Claim elements should not be construed under Section 112, paragraph 6 of the U.S. Patent Act unless they are expressly described using the phrase “means for,” or, in the case of method claims, using the phrase “step for.” Furthermore, to the extent that terms such as “include,” “have,” etc., are used, such terms are intended to be as comprehensive as the term “comprise,” as “comprise” is understood when “comprise” is adopted as a substitute in the claims.

[0093] The title of the invention, background art, summary of the invention, brief description of the drawings, and abstract of the invention of this disclosure are incorporated herein by specification and provided as illustrative examples of the disclosure, not as restrictive descriptions. They are presented with the understanding that they are not used to limit the scope or meaning of the claims. In addition, in the modes for carrying out the invention, it can be seen that the descriptions provide illustrative examples and that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of the disclosure should not be interpreted as reflecting an intention that the claimed subject matter requires more features than are explicitly described in each claim. Rather, as reflected in the following claims, the subject matter of the invention exists in less than all features of a single disclosed configuration or operation. The following claims are incorporated herein by specification and each claim exists as separately claimed subject matter.

[0094] The claims are not intended to be limited to the embodiments described herein, but should be given the full scope consistent with the language claims and should encompass all legal equivalents. Nevertheless, no claim is intended to contain subject matter that does not satisfy the requirements of Sections 101, 102, or 103 of the U.S. Patent Act, and no claim should be interpreted as such.

Claims

1. A fluid connector assembly, The first connector and A second connector configured to connect with the first connector, the second connector having a snap member disposed at one end of the second connector, A coupling mechanism coupled to the second connector for detachably connecting the first connector and the second connector, A body having a passage that extends through to provide fluid communication between the first connector and the second connector, The device comprises a connecting mechanism having at least one projection extending from one end of the main body, When the coupling mechanism is coupled to the second connector, at least a portion of the coupling mechanism is positioned within the opening of the snap member and secured by the at least one projection. A fluid connector assembly in which the coupling mechanism can be disconnected from the second connector by operating the snap member.

2. The coupling mechanism remains coupled to the second connector by a threshold force. The fluid connector assembly according to claim 1, wherein when an external force greater than the threshold force is applied to at least one of the first connector and the second connector, the coupling mechanism is separated from the second connector.

3. The fluid connector assembly according to claim 2, wherein the external force is a tensile force of at least 2.27 kg (5 pounds).

4. The snap member includes at least one snap arm extending from one end of the snap member, The fluid connector assembly according to claim 1, wherein the coupling mechanism can be separated from the second connector by acting on at least one snap arm.

5. The coupling mechanism further comprises a valve member disposed within the passage, When the first connector and the second connector are connected, the valve member is configured to enable fluid communication between the first connector and the second connector. The fluid connector assembly according to claim 1, wherein the valve member is configured to prevent the flow of fluid through the passage when the first connector and the second connector are separated.

6. The at least one projection extends outward with respect to the central axis extending in the longitudinal direction, The fluid connector assembly according to claim 1, wherein the outer contour of at least one projection corresponds to the inner contour of the opening of the snap member.

7. At least a portion of the coupling mechanism is coupled to the outer surface of the second connector, When a tensile force greater than the threshold force is applied to the second connector in the direction along the central longitudinal axis, the coupling mechanism activates the snap member, thereby separating the first connector and the second connector. The fluid connector assembly according to claim 1, wherein at least a portion of the coupling mechanism remains coupled to the second connector when the first connector and the second connector are separated.

8. The fluid connector assembly according to claim 1, wherein the fluid connector assembly is a closed-type drug transfer device.

9. A method for joining fluid connector assemblies, The steps include providing a first connector, A step of providing a second connector configured to be coupled with the first connector, wherein the second connector has a snap member disposed at one end of the second connector, A step of providing a coupling mechanism configured to connect the first connector and the second connector, wherein the coupling mechanism comprises a body and at least one projection extending from one end of the body; The steps include connecting one end of the connecting mechanism to the second connector such that at least a portion of the connecting mechanism is disposed within the opening of the snap member, A method comprising the step of connecting the first connector to the opposite end of the coupling mechanism so that the first connector, the second connector, and the coupling mechanism are in fluid communication.

10. The method according to claim 9, wherein the step of connecting the end of the connecting mechanism to the second connector includes positioning the at least one projection within the opening of the snap member such that the outer surface of the at least one projection abuts against the inner surface of the snap member in a snap-fit ​​configuration.

11. The method according to claim 10, wherein separating the coupling mechanism from the second connector includes acting the snap member to create a gap between the at least one projection and the inner surface, thereby allowing the coupling mechanism to be removed from the opening.

12. The coupling mechanism remains coupled to the second connector by a threshold force. The method according to claim 9, wherein when an external force greater than the threshold force is applied to at least one of the first connector and the second connector, the coupling mechanism is separated from the second connector.

13. The coupling mechanism further comprises a valve member disposed in a passage formed within the main body of the coupling mechanism, When the first connector and the second connector are connected, the valve member is configured to enable fluid communication between the first connector and the second connector. The method according to claim 9, wherein the valve member is configured to prevent the flow of fluid through the passage when the first connector and the second connector are separated.

14. A fluid connector assembly, The first connector and A second connector configured to connect with the first connector, comprising a snap member having at least one arm protruding from one end of the snap member, and a closing system comprising the second connector, A coupling mechanism for detachably connecting the first connector and the second connector, A body having a passage that extends through to provide fluid communication between the first connector and the second connector, A valve member is disposed within the passage to control the flow of fluid through the passage, A first projection extending from the first end of the main body for coupling with the first connector, A coupling mechanism comprising a second projection extending from the second end of the main body for coupling with the second connector, When the coupling mechanism is coupled to the second connector, at least a portion of the coupling mechanism is positioned within the opening of the snap member and secured by the second projection. A fluid connector assembly in which the coupling mechanism is separated from the second connector when the separating force exceeds a predetermined threshold.

15. The fluid connector assembly according to claim 14, wherein the predetermined threshold is a tensile force of at least 2.27 kg (5 pounds).

16. The at least one arm includes a first snap arm protruding from a first side of the second connector and a second snap arm protruding from a second side of the second connector opposite to the first side, The fluid connector assembly according to claim 14, wherein the coupling mechanism can be separated from the second connector by operating the first snap arm and the second snap arm.

17. When the first connector and the second connector are connected, the valve member is configured to enable fluid communication between the first connector and the second connector. The fluid connector assembly according to claim 14, wherein the valve member is configured to prevent the flow of fluid through the passage when the first connector and the second connector are separated.

18. Each of the first projection and the second projection extends outward with respect to the central axis extending in the longitudinal direction of the connecting mechanism, The fluid connector assembly according to claim 14, wherein the outer contour of the second projection corresponds to the inner contour of the opening of the snap member.

19. The fluid connector assembly according to claim 14, wherein the coupling mechanism includes a ring member that is slidably disposed on the outer surface of the second connector and configured to actuate the snap member.

20. The fluid connector assembly according to claim 19, wherein if the separating force exceeds a predetermined threshold, the ring member slides along the second connector until the ring member is positioned on the at least one arm, thereby activating the snap member.

Images