Fluid connector assembly

Abstract

A fluid connector assembly that seals a fluid path in a corresponding connector is disclosed. The connectors may be coupled by a connection mechanism that provides a threshold retention force. When an external force greater than a threshold force is applied to the fluid connector assembly, the snap mechanism no longer holds the connectors together causing the connectors to separate from each other. Once disengaged, the connector may be sterilized and / or replaced prior to recoupling.

Description

Technical Field

[0001] The present invention and disclosure generally relate to medical fluid connectors, and more particularly, to a fluid connector assembly that includes medical connectors that separate from each other due to an applied force, each medical connector being designed to automatically close their respective fluid paths. The separation may be due to an intentional or unintentional separation between the medical connectors. Background Art

[0002] The present disclosure generally relates to medical fluid connectors, and more particularly, to coupling devices for connecting and disconnecting medical tubing.

[0003] Medical connections are widely used in fluid delivery systems, such as those used in connection with intravenous (IV) fluid lines, blood access, hemodialysis, peritoneal dialysis, enteral nutrition, vial access, and other procedures.

[0004] In some cases, a medical connection may become dislocated or disconnected in an unexpected manner. For example, when an unexpected or unanticipated force is applied to a catheter, this may exceed the design limits of the catheter attachment method, and the medical tubing of an IV kit coupled to the catheter may become dislocated. When a patient moves or turns over in a bed, or when a portion of the tubing or another part of the IV kit is caught by a part of the bed (such as a railing), or when a patient panics, becomes disoriented, or fidgets to the extent that the medical tubing is inadvertently or intentionally pulled away from the patient or from medical equipment to which the tubing is coupled, an unexpected or unanticipated force is applied to the tubing and / or catheter. Summary of the Invention

[0005] According to at least some embodiments disclosed herein, it is recognized that an unexpected dislocation or disconnection of a medical connection (such as a medical fluid line) can cause harm to a patient or a healthcare professional, such as by causing a patient to lose medication, increasing the likelihood of patient infection, and exposing a healthcare professional to harmful medications.

[0006] Aspects of the present disclosure provide a fluid connector assembly having medical connectors, each medical connector including one or more fluid paths that respond to an unexpected or unanticipated external force by separating from each other and sealing their respective fluid paths. The separation can include automatic separation using a bellows or other elastically compressible member that decompresses and returns to its original shape when the external force is no longer acting on it. Advantageously, the fluid connector assemblies described herein can limit or prevent patient blood loss, IV fluid loss, infection, and medical delivery delays. Additionally, aspects of the present disclosure provide a connection mechanism that facilitates connection of the fluid connector assembly in the event that the fluid connector assembly is separated.

[0007] According to certain embodiments, a fluid connector may include a first connector having a first housing and a second connector having a second housing. The second connector may be configured to couple with the first connector. The fluid connector may further include a connection mechanism disposed on at least one of the first connector and the second connector for removably coupling the first connector and the second connector. When a predetermined tensile force is applied to at least one of the first connector and the second connector, the connection mechanism disengages, allowing the first connector and the second connector to separate. When the first connector and the second connector separate, an inner surface of one of the first connectors is exposed, allowing for disinfection.

[0008] In some embodiments, the first connection mechanism includes a first connection member coupled to one of the first connector or the second connector. The first connection member may include a protrusion member disposed at a first end of the first connection member.

[0009] In some embodiments, the fluid connector includes a second connection member. The first connection member may be coupled to the first connector and the second connection member is coupled to the second connector. The second connection member may include a groove for receiving the protrusion member. When the first connector and the second connector are coupled, the first connection member and the second connection member may be coupled such that the protrusion is received within the groove. When a predetermined force is applied, the first connection member and the second connection member may separate.

[0010] In some embodiments, the first connection member is a compression ring. The first connection member may be flexible. The second connection member may further include a groove for receiving the protrusion of the compression ring.

[0011] In some embodiments, when the first connector and the second connector are coupled, the first connection member and the second connection member are coupled, and when a predetermined force is applied, the first connection member and the second connection member may separate.

[0012] In some embodiments, the protrusion is configured to engage an elastomeric ring, and when a predetermined force is applied, the protrusion may disengage from the elastomeric ring, causing the first connector and the second connector to separate.

[0013] In some embodiments, the connection member includes an elastic band disposed around the first connector or the second connector and one or more engagement portions. The elastic band may be disposed around a line. The elastic band may be configured to deflect until a predetermined threshold force is applied. When the predetermined threshold force is applied, the elastic band may expand, allowing the engagement portion to be pulled, thereby separating the first connector and the second connector.

[0014] According to certain embodiments, a fluid connector may include a first connector having a first housing and a second connector having a second housing. The second connector may be configured to couple with the first connector. The fluid connector may further include a connection mechanism disposed on at least one of the first connector and the second connector for removably coupling the first connector and the second connector. When a predetermined tensile force is applied to at least one of the first connector and the second connector, the first connector and the second connector may separate.

[0015] In some embodiments, the connection mechanism includes a first connection member coupled to one of the first connector or the second connector. The first connection member may include a protrusion member disposed at a first end of the first connection member.

[0016] In some embodiments, the fluid connector includes a second connection member. The first connection member may be coupled to the first connector, and the second connection member may be coupled to the second connector. The second connection member may include a groove for receiving the protrusion member. When the first connector and the second connector are coupled, the first connection member and the second connection member may be coupled such that the protrusion is received within the groove, and when a predetermined force is applied, the first connection member and the second connection member may separate.

[0017] In some embodiments, when the first connector and the second connector are coupled, the first connection member and the second connection member may be coupled, and when a predetermined force is applied, the first connection member and the second connection member may separate.

[0018] In some embodiments, the protrusion may be configured to engage an elastomeric ring, and when a predetermined force is applied, the protrusion disengages from the elastomeric ring, thereby separating the first connector and the second connector.

[0019] According to certain embodiments, a fluid connector may include a first connector having a first housing and a second connector having a second housing. The second connector may be configured to couple with the first connector and may include a first connector member and a second connector member. The fluid connector may further include a connection mechanism disposed on at least one of the first connector and the second connector for removably coupling the first connector and the second connector, thereby allowing the first connector member to separate from the second connector member. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Various features of illustrative embodiments of the present invention are described below with reference to the drawings. The illustrated embodiments are intended to illustrate and not to limit the present invention. The drawings include the following figures:

[0021] Figure 1 A coupling device for a medical tubing for use with an IV set coupled to a patient is shown in accordance with aspects of the present disclosure.

[0022] Figure 2 Shows a perspective view of an embodiment of a coupling device for a medical tube according to aspects of the present disclosure.

[0023] Figure 3 Shows according to aspects of the present disclosure Figure 2 A perspective view of a coupling device for a medical tube.

[0024] Figure 4 Shows according to aspects of the present disclosure Figure 2 A cross-sectional view of a coupling device for a medical tube.

[0025] Figure 5 Shows according to aspects of the present disclosure Figure 2 A perspective view of a coupling device for a medical tube and a mating connector.

[0026] Figure 6 Shows according to aspects of the present disclosure Figure 4 A detailed cross-sectional view of a coupling device for a medical tube.

[0027] Figure 7 Shows a detailed cross-sectional view of an embodiment of a coupling device for a medical tube according to aspects of the present disclosure.

[0028] Figures 8 - 10 Shows according to aspects of the present disclosure Figure 2 A cross-sectional view of a coupling device for a medical tube and a mating connector.

[0029] Figure 11 Shows a cross-sectional view of an embodiment of a connection mechanism for a coupling device according to aspects of the present disclosure.

[0030] Figure 12 Shows a cross-sectional view of an embodiment of a connection mechanism for a coupling device according to aspects of the present disclosure.

[0031] Figure 13 Shows a cross-sectional view of an embodiment of a connection mechanism for a coupling device according to aspects of the present disclosure.

[0032] Figure 14 Shows a cross-sectional view of an embodiment of a connection mechanism for a coupling device according to aspects of the present disclosure.

[0033] Figure 15 Shows a cross-sectional view of an embodiment of a connection mechanism for a coupling device according to aspects of the present disclosure.

[0034] Figure 16 Is a perspective view of an expansion kit including a connector assembly according to some embodiments of the present disclosure.

[0035] Figure 17 A cross-sectional view of a connector assembly coupled to a mating needleless connector in accordance with some embodiments of the present invention is shown.

[0036] Figure 18 A partial perspective view of a connector assembly in accordance with some embodiments of the present disclosure is shown Figure 17 thereof.

[0037] Figure 19 An operational view of a connector assembly separating from a mating needleless connector due to pivoting open of a distal connector of the connector assembly when the connector assembly is subjected to a force in a proximal direction above a predetermined threshold in accordance with some embodiments of the present invention is shown.

[0038] Figure 20 An operational cross-sectional view of a proximal connector of a connector assembly separated from the connector assembly for scrubbing in accordance with some embodiments of the present disclosure is shown.

[0039] Figure 21 An operational cross-sectional view of a proximal connector of a connector assembly coupled to the remainder of the connector assembly after scrubbing in accordance with some embodiments of the present disclosure is shown.

[0040] Figure 22 A front view of a detachable connector assembly in accordance with some embodiments of the present disclosure is shown.

[0041] Figure 23 A cross-sectional view of a connector assembly in accordance with some embodiments of the present disclosure is shown Figure 22 thereof.

[0042] Figure 24 A detailed view of a connector assembly in accordance with some embodiments of the present disclosure is shown Figure 23 thereof.

[0043] Figure 25 A cross-sectional view of an arm for a connector assembly in accordance with some embodiments of the present disclosure is shown.

[0044] Figure 26 A cross-sectional view of an arm in accordance with some embodiments of the present disclosure is shown Figure 25 thereof. DETAILED DESCRIPTION

[0045] Numerous specific details are set forth in the following detailed description in order to provide a thorough understanding of the subject technology. It should 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.

[0046] In addition, although the present specification sets forth specific details of various embodiments, it is to be understood that the specification is illustrative only and should not be construed in any way as restrictive. Further, it is contemplated that although specific embodiments of the present disclosure may be disclosed or shown in the context of an IV set, these embodiments may be used in other fluid delivery systems. Moreover, various applications of these embodiments and their modifications that may be contemplated by those skilled in the art are also covered by the general concepts described herein.

[0047] According to some embodiments, the present application discloses various features and advantages of a coupling device for medical tubing. The coupling device for medical tubing can provide effective and safe maintenance of a fluid connection, such as a connection for delivering medical fluid to or from a patient. When a pulling force or tension is applied to the coupling device, such as when a patient moves or when the medical tubing is pulled away from the patient, the coupling device can maintain the fluid connection of the medical tubing by preventing disconnection. The coupling device also prevents injury to the patient or caregiver by permitting disconnection of the fluid connection when the pulling force or tension exceeds a threshold. The coupling device also provides effective and safe reconnection of the fluid line by permitting the coupling device to be reconnected to a fluid delivery device, such as a catheter or a needleless connector, thereby reestablishing the fluid pathway without the need to replace the coupling device. The coupling device may also include features that permit safe and effective disinfection and cleaning of parts of the device prior to connection and reconnection.

[0048] Referring now to the drawings, Figure 1 an embodiment of a coupling device for medical tubing in use is shown in accordance with aspects of the present disclosure. The coupling device 10 is coupled to the tubing of an IV set for guiding fluid to a patient 1. The IV set may include a drug bag 12, a drip chamber 14, tubing 16, and an IV catheter 18.

[0049] The coupling device 10 fluidly connects the tubing 16 to the IV catheter 18. Although the coupling device 10 is shown as being coupled between the drug bag 12 and the patient 1 along the fluid pathway of the IV set, it is to be understood that the coupling device 10 may be connected within other fluid pathways, such as between the patient and an IV pump or between the patient and a dialysis machine. The coupling device 10 may also be connected along another portion of the fluid pathway. For example, the coupling device 10 may be connected along the proximal portion of the fluid pathway, such as between the tubing 16 and the drug bag 12 or other fluid treatment device.

[0050] The coupling device 100 includes a housing 110 and an inner body 150 that is at least partially located within the inner cavity of the housing 110. The coupling device may further include coupling mechanisms 200, 300, 400, 500, 600 that are configured to couple with a mating connector 20. The structures of the coupling mechanisms 200, 300, 400, 500, 600 will be described in further detail below.

[0051] When the coupling device 100 is in a first configuration, the inner body 150 is in a first position within the cavity of the housing 110, whereby the coupling sleeve of the inner body 150 prevents the mating connector 20 from separating or disconnecting from the coupling device 100.

[0052] In some embodiments of the present disclosure, when the inner body 150 is in the first position, the end of the inner body is substantially aligned or coplanar with the end of the housing. In some embodiments, when the inner body 150 is in the first position, a portion of the coupling mechanisms 200, 300, 400, 500, 600 of the inner body 150 or another portion of the inner body may extend through the end of the housing a first distance D21.

[0053] When the coupling device 100 is in the first configuration and the inner body 150 is in the first position, the coupling device 100 may be able to prevent the mating connector 20 from inadvertently separating from the coupling device 100 by preventing the coupling mechanisms 200, 300, 400, 500, 600 from deviating or bending away from the mating connector 20. In some embodiments of the present disclosure, the housing 110 prevents the coupling mechanisms 200, 300, 400, 500, 600 from deviating radially outward, such that when the mating connector 20 and the coupling device 100 are pulled away from each other, the coupling mechanisms 200, 300, 400, 500, 600 will engage against a portion of the housing 110, thereby preventing the mating connector 20 from moving out of the sleeve.

[0054] When the tensile force or tension exceeds the threshold of the coupling device 100, the coupling device 100 may move from the first configuration to the second configuration, as Figure 3 shown. For example, when a patient moves in an unexpected manner, or when a medical tube is pulled away from the patient, a tensile force or tension FA, FB may be applied to the mating connector 20 or the tube 16 in a direction away from the coupling device 100. In at least some instances of the present disclosure, the tensile force or tension FA is in a distal direction relative to the coupling device, and the tensile force or tension FB is in a proximal direction.

[0055] If the pulling or tension forces FA, FB exceed a first threshold of the coupling device 100, either the housing 110 or the inner body 150 can move away from each other such that the inner body 150 moves from a first position to a second position. The movement of the housing 110 and the inner body 150 relative to each other can be along the longitudinal axis of the inner body 150, which extends between the mating connector 20 and the end portion of the pipe fitting 16 connected to the coupling device 100.

[0056] In the second position of the inner body 150, at least a portion can extend out of the cavity and away from the end of the housing 110 by a second distance D31. The second distance can be greater than the first distance between the distal end of the sleeve and the end of the housing when the inner body 150 is in the first position.

[0057] If the pulling or tension forces FA, FB exceed a second threshold of the coupling device 100, the connecting mechanisms 200, 300, 400, 500, 600 can be configured such that the engagement of the mating connector 20 against the sleeve can cause at least a portion of the connecting mechanisms 200, 300, 400, 500, 600 to deflect or bend away from the mating connector 20. When the connecting mechanism bends away from the mating connector 20, the resistance to the separation of the coupling device 100 from the mating connector 20 can be reduced relative to when the coupling device 100 is in a first configuration, thereby permitting the separation of the coupling device 100 from the mating connector 20. In some embodiments, when the forces FA, FB exceed the second threshold, the engagement of the threads of the mating connector 20 against the threads of the inner body 150 causes a portion of the sleeve to bend away from the mating connector 20. In some aspects of the present disclosure, when the forces FA, FB exceed the second threshold of the coupling device 100, the threads of the coupling device 100 can skip or pass over the threads of the mating connector 20.

[0058] Figure 4 A cross-sectional front view of the coupling device 100 is shown. The coupling device 100 can include a housing 110, an inner body 150, and an inner body biasing element 180. The inner body 150 can be configured to prevent and / or permit the separation of the mating connector 20 from the coupling device. In some aspects of the present disclosure, when the inner body is in a first position, the separation of the mating connector 20 from the coupling device can be prevented, while when the inner body is in a second position, the separation of the mating connector 20 from the coupling device can be permitted. For example, the first position of the inner body 150 is shown in Figure 4 and Figure 5 , and the second position of the inner body 150 is shown in, for example, Figure 6 and Figure 7 .

[0059] The inner body 150 may be located within a cavity formed by the inner surface of the housing 110 and may be movable between a first position and a second position. The inner body 150 may be positioned within the cavity at a location along the distal end portion of the housing. The inner body biasing element 180 may also be positioned within the cavity to bias the inner body 150 in the proximal direction to prevent the mating connector 20 from separating from the coupling device 100.

[0060] The housing 110 may include a proximal end portion 113 that forms a first end 114 and a distal end portion 115 that forms a second end 112. The first end 114 is opposite the second end 112, and a longitudinal axis A1 is defined between the first end and the second end of the housing. The inner surface 116 of the housing forms a cavity 118 that extends between the first end 114 and the second end 112 and is configured to receive the inner body 150 within the cavity.

[0061] The first end 114 of the housing or a portion of the housing adjacent to the first end 114 may form a first opening of the housing, and the first opening may be configured to permit a pipe fitting to be positioned through the first opening into the cavity. The second end 112 of the housing or a portion of the housing adjacent to the second end 112 may form a second opening of the housing, and the second opening may be configured to permit the inner body 150 to be inserted into the cavity through the second opening.

[0062] In some embodiments of the present disclosure, the inner surface 116 of the housing forms a ridge 117 that extends between the first end 114 and the second end 112 of the housing. In some aspects of the present disclosure, a portion of the inner body 150 is positioned between the ridge 117 of the housing and the second end 112, and the inner body 150 is longitudinally movable between the ridge 117 and the second end 112 of the housing.

[0063] In embodiments of the present disclosure, the inner surface 116 of the housing forms any one of a groove and / or a ridge, and the inner body 150 forms the other of the groove and / or the ridge, wherein the groove and / or the ridge of the housing and the inner body may extend in a longitudinal direction generally parallel to the longitudinal axis A1 of the housing.

[0064] The groove and / or the ridge of the housing 110 may be configured to cooperate or engage with the inner body 150 such that when the housing 110 rotates about the longitudinal axis A1, a portion of the housing 110 that forms the groove and / or the ridge may engage against a portion of the inner body 150, thereby causing the inner body 150 to rotate with the housing 110. By rotatably coupling the housing 110 and the inner body 150, the housing 110 may be rotated to engage the threads of the inner body 150 with complementary threads of the mating connector 20.

[0065] The second end portion 152 of the inner body may also form a luer projection 157 that is configured to engage a mating connector 20 and forms part of a fluid passage through the coupling device 100.

[0066] The luer projection 157 may be formed by the second end portion 152 of the inner body and may have an outer surface that forms a male luer shape. The structure and orientation of the luer projection 157 may be such that the luer projection extends through a recess defined by the coupling sleeve 156 that extends around the perimeter or circumference of the luer projection 157.

[0067] In some embodiments of the present disclosure, the inner surface of the coupling sleeve 156 is spaced from the outer surface of the luer projection 157. The space between the coupling sleeve 156 and the luer projection 157 may permit the mating connector 20 to be attached to the coupling device 100, where a portion of the mating connector 20 is positioned between the coupling sleeve 156 and the luer projection 157. In some aspects of the present disclosure, the luer projection 157 is configured to displace a valve of the mating connector 20.

[0068] The inner surface of the luer projection may form part of a valve passage 159 that extends through the inner body 150 and along its second end portion 152. When coupled to the mating connector 20 in either the first position or the second position of the inner body 150, the valve passage 159 may permit fluid to pass through the coupling device 100.

[0069] The inner body biasing element 180 may be positioned within a cavity of the housing 110 to direct or bias the inner body 150 toward the first position. To bias the inner body 150 toward the first position, or in a direction toward the first end 114 of the housing, the biasing element 180 may be positioned between the inner body 150 and the second end 112 of the housing.

[0070] The inner body biasing element 180 may be a spring, an elastic bellows, or any similar structure configured to move the inner body 150. The first end of the inner body biasing element 180 may engage against the inner body 150, and the second end of the inner body biasing element 180 may engage against a portion of the housing 110 at its second end 112.

[0071] In some embodiments of the present disclosure, a portion of the inner body 150 forms a flange 181 that is configured to engage against the inner body biasing element 180. The flange 181 may be positioned along the second end portion 152 of the inner body and extends radially outward in a direction away from the longitudinal axis A2 of the inner body. The flange 181 may extend around the perimeter of the inner body 150, or may be formed by a series of discontinuous flanges 181 that are separated from each other around the perimeter of the inner body 150.

[0072] When the inner body 150 is positioned within the cavity of the housing 110, the first end of the inner body biasing element 180 can engage against the flange 181, and the second end of the inner body biasing element 180 can engage against the housing 110. The biasing element 180 exerts a force on the flange 181 of the inner body, thereby biasing the inner body 150 in the proximal direction toward the first end 114 of the housing.

[0073] In some embodiments of the present disclosure, the ridge 117 of the housing is configured to prevent the inner body 150 from moving toward the first end 114 of the housing. When the inner body 150 is in the first position, the flange 181 of the inner body can engage against the ridge 117 of the housing flange 120, and when the inner body 150 is in the second position, the flange 181 of the inner body is spaced apart from the ridge 117 of the housing.

[0074] In some embodiments of the present disclosure, the cap 190 is coupled to the second end 112 of the housing to retain the inner body biasing element 180 and the inner body 150 within the cavity of the housing. In such embodiments, the second end of the inner body biasing element 180 can engage against the cap 190.

[0075] The cap 190 can include a passage that defines at least a portion of a second opening through the second end 112 of the housing. The cross-sectional width of the passage through the cap 190 can be less than the cross-sectional width formed by the cavity of the housing, such that the cap 190 can prevent the inner body biasing element 180 from moving out of the cavity and permit the inner body to move out of the cavity through the passage of the cap 190.

[0076] In some aspects of the present disclosure, the cap 190 can be integrally formed with the housing 110 to form a ridge or flange of the housing that extends radially inwardly toward the longitudinal axis A1 of the housing.

[0077] To permit or prevent fluid flow through the Luer projection, the coupling device 100 can include a valve 170. The valve 170 can be positioned within the cavity of the housing 110 and can move between the first end 114 and the second end 112 of the housing. The valve 170 can also be configured to move relative to the housing 110 and the inner body 150 such that the valve 170 is movable when the inner body 150 is in either the first position or the second position.

[0078] The valve 170 can move between a closed position and an open position. In the closed position, the valve 170 can prevent fluid from moving through the coupling device 100. In some embodiments of the present disclosure, in the closed position, the valve 170 blocks the valve passage 159 to prevent fluid from moving therethrough. In the open position, the valve 170 can move relative to the inner body 150 to permit fluid flow through the inner body 150 and the valve 170. For example, in Figure 4 andFigure 5 The closed and open positions of valve 170 are respectively shown therein.

[0079] Valve 170 may include a proximal end portion 171 and a distal end portion 172, wherein the distal end portion forms a post 174 and an arm 176. The inner surface of valve 170 may define a fluid flow passage 178 that extends through the proximal end portion and the distal end portion of valve 170. In some aspects of the present disclosure, a portion of the fluid flow passage is formed by an opening 182 that extends radially between the inner surface and the outer surface of post 174.

[0080] The arm 176 of the valve may be configured to engage against mating connector 20 such that when mating connector 20 is coupled to coupling device 100, valve 170 moves in a direction from the closed position toward the open position.

[0081] Arm 176 may extend along post 174 and in a direction away from the proximal end portion 171 of the valve. Arm 176 may include a first segment 184 and a second segment 186, the first segment extending radially outward in a direction away from the outer surface of the post, and the second segment extending from the first segment in a direction along the post and away from the proximal end portion 171 of the valve.

[0082] In some embodiments of the present disclosure, the first segment 184 extends radially outward along a portion of valve 170 between the proximal end portion 171 and the distal end portion 172. The first segment 184 may include a length greater than the thickness of arm 176 such that the inner surface of arm 176 is spaced apart from the outer surface of post 174.

[0083] Valve 170 may be positioned in a cavity of housing 110, post 174 extends into valve passage 159 of the Luer projection, and the arm may be positioned to extend between the outer surface of the Luer projection and the inner surface of the coupling sleeve. The proximal end portion 171 of the valve may extend through passage 159 formed through the first end portion 154 of the inner body.

[0084] The outer surface of post 174 may define a cross-sectional width that is smaller than the cross-sectional width defined by the inner surface of Luer projection 157, thereby forming a gap therebetween. The gap may permit fluid to pass between the outer surface of post 174 and the inner surface of Luer projection 157 through opening 182.

[0085] In some embodiments, post 174 includes a radially outwardly extending protrusion 188 to engage against the inner surface of Luer projection 157. Protrusion 188 may be configured to engage against the Luer projection to prevent the post from moving in a direction that is non-linear or transverse relative to the longitudinal axis A2 within valve passage 159. In some aspects, protrusion 188 may prevent non-linear or transverse movement of post 174 when the valve moves between the open position and the closed position.

[0086] In the closed position of valve 170, post 174 may block or penetrate through the opening of luer projection 157 to prevent fluid from flowing through the opening. When valve 170 is moved to the open position, post 174 may be spaced apart from the opening of luer projection 157 relative to when valve 170 is in the closed position to permit fluid to move through valve passage 159 of the luer projection and through valve 170.

[0087] In some embodiments of the present disclosure, arm 176 includes a cylindrical extension 192 that extends from arm 176 in a direction away from the first end 114 of the housing. Cylindrical extension 192 may be configured to direct a force to arm 176 such that when coupling device 100 is coupled to a mating connector, valve 170 moves relative to inner body 150. Cylindrical extension 192 may also be configured to engage a luer projection engagement against the inner body to form a seal between cylindrical extension 192 and luer projection 157. The seal formed between cylindrical extension 192 and luer projection 157 may prevent unintended substances, such as fluids and / or solids, from moving into or out of the cavity of housing 110.

[0088] Cylindrical extension 192 may extend from the second segment 186 of the arm to a terminal 193 that is positioned proximate the distal end of luer projection 157. Cylindrical extension 192 and arm 176 may define a length between the first segment 184 and the terminal 193 of the cylindrical extension.

[0089] In some embodiments of the present disclosure, the lengths of cylindrical extension 192 and arm 176 are configured such that the terminal 193 of the cylindrical extension is proximate the distal end of luer projection 157 and the furthest distal portion of luer projection 157 extends beyond the terminal 193 of the cylindrical extension, as shown in the detailed view of Figure 6 In such embodiments, the terminal 193 of the cylindrical extension is spaced apart from a plane P1 defined by the distal end of luer projection 157.

[0090] In some embodiments of the present disclosure, the lengths of cylindrical extension 192 and arm 176 are configured such that the terminal 193 of the cylindrical extension is coplanar or aligned with a plane P1 defined by the distal end of luer projection 157, as shown in the detailed view of Figure 7 In such embodiments, the terminal 193 of the cylindrical extension is spaced apart from a plane P1 defined by the distal end of luer projection 157.

[0091] In some embodiments of the present disclosure, the seal between the arm 176 and the luer protrusion 157 is formed by a valve seal 196. The valve seal 196 can be coupled to either the arm 176 or the cylindrical extension 192 and can be configured to engage against the outer surface of the luer protrusion 157. When the valve 170 moves between the closed position and the open position, the valve seal 196 can engage the outer surface of the luer protrusion 157 to maintain the seal.

[0092] The valve seal 196 can be coupled to the terminal 193 of the cylindrical extension and radially extends inwardly in a direction towards the outer surface of the luer protrusion 157. The present disclosure contemplates that the valve seal 196 can be coupled to a portion of the arm 176 and / or the cylindrical extension 192 that is close to or spaced apart from the terminal 193 of the cylindrical extension.

[0093] In some embodiments of the present disclosure, the valve seal 196 can include a proximal layer 197 and a distal layer 198, wherein each of the proximal layer 197 and the distal layer 198 extends in a direction away from the cylindrical extension 192. Each of the proximal layer 197 and the distal layer 198 includes a length that extends in a direction from the cylindrical extension 192 to the end of each respective layer. In some embodiments, for example as Figure 6 shown, the length L61 of the proximal layer 197 is approximately equal to the length L62 of the distal layer 198. In some embodiments, for example as Figure 7 shown, the length L61 of the proximal layer 197 is less than the length L63 of the distal layer 198.

[0094] In some embodiments of the present disclosure, an inner body seal 155 forms a seal between the inner body 150 and the valve 170 to prevent the movement of unintended substances, such as fluids and / or solids, into or out of the cavity of the housing 110.

[0095] To maintain the seal between the inner body 150 and the valve 170, the inner body seal 155 can be configured to move relative to either the inner body 150 or the valve 170. The inner body seal 155 can be coupled to the inner surface of the coupling sleeve 156 and can be configured to engage against either the arm 176 or the cylindrical extension 192 when the valve 170 moves between the open position and the closed position to form a seal.

[0096] Although the inner body seal 155 can be coupled to the inner body 150, it should be understood that in some embodiments, the present disclosure contemplates that the inner body seal 155 can be coupled to the valve 170.

[0097] The proximal end portion 171 of the valve can be fluidly connected to the pipe fitting 16 to permit fluid flow through the fluid flow path 178 and the pipe fitting 16. The pipe fitting 16 extends through the first end portion 114 of the housing and is coupled to the proximal end portion 171 of the valve. In some embodiments, another length of pipe fitting or bellows is positioned between the proximal end portion 171 of the valve and the first end portion 114 of the housing, and the pipe fitting 16 can be coupled to the first end portion 114 of the housing.

[0098] The coupling device 100 and the mating connector 20 are shown together in Figures 8 - 10 wherein the coupling device 100 is in a second configuration in Figure 8 and Figure 9 and in a first configuration in Figure 10

[0099] After the tensile force or tension FA, FB exceeds a first threshold of the coupling device 100, the coupling device 100 can move to the second configuration. When the mating connector 20 is coupled to the coupling device 100 and the tensile force or tension exceeds the threshold of the coupling device 100, the mating connector 20 moves relative to the housing 110 together with the inner body 150. As the coupling device 100 moves to the second configuration, the inner body 150 moves in a direction away from the first end portion 114 of the housing, and the inner body biasing element 180 is compressed between the inner body 150 and the housing 110, as Figure 8 shown.

[0100] In the second configuration, the mating connector 20 can remain coupled to the inner body 150 such that the valve 170 remains in the open position and fluid can flow between the mating connector 20 and the coupling device 100. In some embodiments of the present disclosure, when the valve is in the open position, the valve biasing element 175 is compressed between the valve 170 and a portion of the inner body 150.

[0101] In some embodiments, as Figure 11 shown, the connection mechanism 200 can include a first connection member 202 and a second connection member 204. The first connection member 202 can include a first end portion 202A and a second end portion 202B opposite the first end portion 202A. The first connection member 202 can be coupled to the connector housing 110 near the first end portion 202A of the first connection member 202. The second end portion 202B of the first connection member 202 can include a protrusion 206. The protrusion 206 can extend from the surface of the connection member 202. In some embodiments, the protrusion 206 can be disposed at an angle of approximately 45 degrees relative to the surface of the first connection member 202.

[0102] ​The second connecting member 204 may include a first end 204A and a second end 204B. The second connecting member 204 may be coupled to the mating connector 20 near the first end 204A. The second end 204B of the second connecting member 204 may include a groove 208. The groove 208 may be sized and shaped to receive the protrusion 206.

[0103] When the connectors 10, 20 are coupled, the first connecting member 202 and the second connecting member 204 may be coupled such that the protrusion 206 is received within the groove 208. When coupled, the connection between the protrusion 206 and the groove 208 may be strong enough to maintain the coupling of the connectors 10, 20 until a tensile force or tension FA, FB exceeding a threshold is applied to one or both of the connectors 10, 20. In some embodiments, the predetermined threshold force is approximately 5 pounds (lb). The predetermined threshold force may range from approximately 1 lb to approximately 8 lb, approximately 3 lb to approximately 7 lb, approximately 4 lb to approximately 6 lb, or greater than 8 lb. When a tensile force or tension FA, FB exceeding the threshold is applied to one or both of the connectors 10, 20, the protrusion 206 may separate from the groove 208 such that the first connecting member 202 and the second connecting member 204 separate. As a result, the connectors 10, 20 may separate.

[0104] In some embodiments, as Figure 12 shown, the connection mechanism 300 may include a first connecting member 302 and a second connecting member 304. The first connecting member 302 may be formed as a compression ring and may include a first end 302A and a second end 304B opposite the first end 302A. The first connecting member 302A may be coupled to the connector 20 near the first end 302A and may further include a protrusion 306 disposed near the second end 302B. The protrusion 306 may extend from the surface of the first connecting member 302. In some embodiments, the protrusion 304 may include a substantially flat engagement surface 308. However, the flat engagement surface 308 is not so limited and may include an engagement surface having a varying profile. The first connecting member 302 may be configured to be flexible such that it can be bent and / or stretched to a certain extent.

[0105] The second connecting member 304 may include a first end 304A and a second end 304B opposite the first end 304A. The second connecting member 304 may be coupled to the connector 10 at the first end 304A. The second end 304B of the second connecting member 304 may include an engagement surface 310. The engagement surface 310 may be substantially flat.

[0106] When the connectors 10, 20 are coupled, the first connection member 302 and the second connection member 304 may be coupled. In particular, the protrusion 306 may engage the surface of the second connection member 304 such that the engagement surface 308 contacts the surface of the second connection member 304. The first connection member 302 may be biased toward the second connection member 304 such that when coupled, the engagement surface 308 applies pressure to the surface of the second connection member 304. In this way, the first connection member 302 and the second connection member 304 may help maintain the connection between the connectors 10, 20 until a tensile force or tension FA, FB exceeding a threshold is applied to one or both of the connectors 10, 20. In the case of such tensile force or tension FA, FB, the surfaces of the first connection member 302 and the second connection member 304 translate or slide along each other in opposite directions until the first connection member 302 and the second connection member 304 are separated.

[0107] In some embodiments, as ​ shown, the connection mechanism 400 may include a first connection member 402 and a second connection member 404. The connection mechanism 400 may be similar to the connection mechanism 300 described above. In particular, the connection mechanism 400 may be configured as a compression ring and may further include a groove or a stop 410. Similar to the connection mechanism 300, the first connection member 402 may be coupled to the connector 10 at the first end 402A and includes a protrusion 406 disposed near the second end 402B opposite the first end. The protrusion 404 may extend from the surface of the first connection member 402. In some embodiments, the protrusion 404 may include a substantially flat engagement surface 408. However, the flat engagement surface 408 need not be so limited and may include an engagement surface with a varying profile. The first connection member 402 may be configured to be flexible such that it can be bent and / or stretched to a certain extent. Additionally, the second connection member 404 may be coupled to the connector 20 at the first end 404A and may include a groove or a stop 410 near the second end 404B. The groove or the stop 410 may be sized and shaped to receive the protrusion 406 of the first connection member 402.

[0108] Similar to the connection mechanisms 200, 300 described above, the first connection member 402 and the second connection member 404 may help maintain the connection of the connectors 10, 20 until a tensile force or tension FA, FB exceeding a threshold is applied to one or both of the connectors 10, 20. When a tensile force or tension FA, FB exceeding the threshold is applied to one or both of the connectors 10, 20, the protrusion 406 may be removed from the groove or the stop 410, thereby allowing the first connection member 402 and the second connection member 404 to translate or slide relative to each other in opposite directions until the first connection member 402 and the second connection member 404 are separated, thereby allowing the connectors 10,

[0109] In some embodiments, as ​ shown, the connection mechanism 500 may include a first connection member 502 coupled to one of the connectors 10, 20. The first connection member 502 may be coupled to one of the connectors 10, 20 at a first end 502A. The first connection member 502 may include a protrusion 504 disposed near a second end 502B opposite the first end 502A. The protrusion 504 may be formed to have a toothed configuration. In particular, the protrusion 504 may extend outwardly from the surface of the first connection member 502 and may include an inclined portion 506 extending toward the second end 502B of the first connection member 502, thereby creating a stepped surface. The first connection member 502 may be configured to engage an elastomeric ring (not shown) disposed on the other of the connectors 10, 20.

[0110] The coupling of the first connection member 502 and the elastomeric ring (not shown) may help to maintain the coupling of the connectors 10, 20 until a pulling force or tension FA, FB exceeding a threshold is applied to one or both of the connectors 10, 20. When such a pulling force or tension FA, FB is applied to one or both of the connectors 10, 20, the protrusion 504 may slide against the elastomeric ring, thereby enabling the connectors 10, 20 to disconnect.

[0111] In some embodiments, as ​ shown, the connection mechanism 600 may include a first connection member 602 and a second connection member 604. The connection mechanism 602 may be coupled to the connector 10 or the connector 20. The first connection member 602 may be an elastic band, and the second connection member 604 may be one or more engaging portions. The engaging portions 604 may be separated to allow deflection, and the elastic band 602 may be disposed around the engaging portions 604, thereby providing radial support for the engaging portions 604. Additionally, the elastic band 602 may be molded to have different hardnesses and / or thicknesses, thereby allowing different levels of disconnection force.

[0112] Similar to the connection mechanisms 200, 300, 400, 500, when the elastic band 602 is positioned around the engaging portions 604, the connection mechanism 600 may help to maintain the connection of the connectors 10, 20. In the case where a pulling force or tension FA, FB exceeding a threshold is applied to one or both of the connectors 10, 20, the elastic band 602 may expand to allow the engaging portions 604 to be pulled, thereby enabling the disconnection of the connectors 10, 20.

[0113] When the mating connector 20 is separated from the coupling device 100, as described above, the valve 170 may move from the open position ( ​) Move to the closed position such that the valve passage 159 is blocked and fluid flow through the valve passage is prevented, as ​ shown. In some embodiments, the valve biasing element 175 expands to apply a force on the valve 170 to move the valve from the open position toward the closed position.

[0114] After the tensile or tension forces FA, FB decrease to less than a first threshold, the inner body 150 may move from the second position to the first position such that the coupling device 100 is in the first configuration as ​ shown. The inner body 150 may move to the first position such that the coupling device 100 is in the first configuration when the tensile forces FA, FB decrease or when the mating connector 20 separates from the coupling device 100 such that the tensile forces FA, FB no longer exist.

[0115] In some embodiments, after the above disconnection event occurs, the coupling device may be removed and replaced. In other words, when the connection mechanisms 200, 300, 400, 500, 600 are separated and thus the coupling device is disconnected from the mating connector, the coupling device or a portion thereof may be removed and replaced, thereby allowing the user to replace the coupling device with a clean coupling device.

[0116] The coupling device 1200 may include a body portion 1205, a proximal connector 1214 disposed at least partially within the body portion 1205, and a distal connector 1212 slidably coupled to the body portion 1205. The body portion 1205 may have an inner surface defining a cavity 1208 that terminates in an open end 1262 of the body portion 1205, and a Luer portion 1227 that extends within the cavity 1208 and through the open end 1262 of the body portion 1205. The inner surface of the body portion 1205 may include a plurality of notches 1282 recessed therein. In some embodiments, the body portion 1205 may include a plurality of wings 1210. In some embodiments, the plurality of wings 1210 may extend from the outer surface of the proximal connector 1214 to the outer surface 1215 of the distal connector 1212. As will be described in further detail below with respect to the operation of the connector assembly 1201, the distal connector 1212 may be slidably coupled to the proximal connector 1214 via the plurality of wings 1210. In some embodiments, each of the plurality of wings 1210 may have a proximal end 1260 and a distal end that forms the open end 1262. Each wing 1210 may have an inner surface 1264 that includes a first linear portion 1266 extending proximally from the open end 1262, a ramp portion 1252 extending proximally and radially outwardly from the first linear portion 1266, and a second linear portion 1270 extending proximally from the ramp portion 1252.

[0117] The distal connector 1212 can have a first arm 1211 and a second arm 1213 that are pivotable relative to each other (as ​ shown). For example, in some embodiments, the first arm 1211 and the second arm 1213 can each include a pair of hinge portions having coupling holes. The hinge portions and respective coupling holes of the first arm 1211 and the second arm 1213 can be coaxially aligned such that a pivot pin can be inserted into the coupling holes aligned at opposite sides of the first arm 1211 and the second arm 1213. Accordingly, the pair of hinge portions of the first arm 1211 can be rotatably coupled to the pair of hinge portions of the second arm 1213, thereby pivotably coupling the first arm 1211 and the second arm 1213 of the distal connector 1212 to each other.

[0118] The distal connector 1212 can have a first arm 1211 and a second arm 1213 that are pivotable relative to each other (as ​ shown). For example, in some embodiments, the first arm 1211 and the second arm 1213 can each include a pair of hinge portions having coupling holes. The hinge portions and respective coupling holes of the first arm 1211 and the second arm 1213 can be coaxially aligned such that a pivot pin can be inserted into the coupling holes aligned at opposite sides of the first arm 1211 and the second arm 1213. Accordingly, the pair of hinge portions of the first arm 1211 can be rotatably coupled to the pair of hinge portions of the second arm 1213, thereby pivotably coupling the first arm 1211 and the second arm 1213 of the distal connector 1212 to each other.

[0119] In some embodiments of the present disclosure, the ability to pivot the first arm 1211 and the second arm 1213 is provided by the body portion 1205 having a pivot hole or a pivot pin and the first arm 1211 and the second arm 1213 having the other of a pivot hole or a pivot pin. The pivot holes can be located at opposite sides of the body 1205, and each of the first arm 1211 and the second arm 1213 can have a pair of pivot pins configured to be received in the pivot holes.

[0120] Referring to ​ and ​ , which show a cross-sectional view of the connector assembly 1201 in the direction A-A and a detailed view thereof, the body portion 1205 includes a pivot hole 1272, and each of the first arm 1211 and the second arm 1213 includes a pivot pin 1278 configured to be positioned within the pivot hole 1272.

[0121] The second arm 1213 is in ​is shown, and an inner surface 1237 of the distal connector 1212 is shown, which inner surface defines a cavity 1243 that terminates at an open end 1225 of the distal connector. The second arm 1213 includes first and second pivot pins 1278, each pivot pin being positioned along a lateral side portion of the second arm such that the second arm 1213 is pivotable about an axis extending between the first and second pivot pins 1278. In some aspects of the present disclosure, the first and second pivot pins 1278 are radially opposed to each other. Although the second arm 1213 is shown separately for clarity, it should be understood that the present disclosure contemplates that the first arm 1211 may have the same or similar features as the second arm 1213.

[0122] In the case where the pivot pins 1278 of each of the first arm 1211 and the second arm 1213 are positioned in the pivot holes 1272, a partially circular cross-section of each pivot pin 1278 having a perimeter of less than 180 degrees may permit each of the first arm 1211 and the second arm 1213 to pivot relative to the body portion 1205. In some embodiments of the present disclosure, each pivot pin has a circular perimeter extending about an axial center of the pivot pin 1278 by an angle AP. In some embodiments, the angle AP is between about 10 degrees and about 180 degrees. In some embodiments, the angle AP is between about 90 degrees and about 175 degrees. In some embodiments, the angle AP is between about 120 degrees and about 160 degrees. In ​ the illustrated embodiment, the angle AP is 158 degrees.

[0123] In some embodiments of the present disclosure, the proximal and distal ends of the first arm 1211 and the second arm 1213 are configured to move toward and away from the body portion 1205 when either the first arm 1211 or the second arm 1213 pivots. To permit the proximal and distal ends of the first arm 1211 and the second arm 1213 to move toward and away from the body portion 1205, the pivot pins are located between the proximal and distal ends of the first arm 1211 and the second arm 1213. The movement of the proximal and distal ends of the first arm 1211 and the second arm 1213 toward and away from the body portion 205 may also be permitted by the lateral sides of each of the first arm 1211 and the second arm 1213 having a chamfer at their proximal end portions. On the other hand, when the first arm 1211 and the second arm 1213 are coupled to the pivot holes, a space is created between the first arm 1211 and the second arm 1213 that extends from the pivot pins toward the proximal ends of the first arm 1211 and the second arm 1213.

[0124] When the distal connector 1212 moves in the distal direction relative to the proximal connector 1214, the first arm 1211 and the second arm 1213 pivot such that the distal ends of the first arm 1211 and the second arm 1213 move radially outward. When the distal ends of the first arm 1211 and the second arm 1213 move radially outward, the mating connector 1202 can be separated from the distal connector.

[0125] As shown, the first arm 1211 and the second arm 1213 can define (i) an outer surface 1215 of the distal connector 1212, and (ii) an inner surface 1237 of the distal connector 1212, the inner surface defining a cavity 1243 that terminates at an open end 1225 of the distal connector 1212. The inner surface 1237 of the distal connector 1212 can have at least one stop 1230 that extends radially inward from the inner surface 1221 (as ​ shown). As shown, when the mating connector 1202 is coupled to the distal connector 1212, each protrusion 1224 can abut a corresponding one of the at least one stop 1230 to prevent unintended expansion of the compressible valve member 1218 and distal movement of the post 1220.

[0126] As further described, each of the first arm 1211 and the second arm 1213 can include at least one stop portion 1209 that extends radially outward from the outer surface 1215 of the distal connector 1212. When the distal connector 1212 is coupled to the mating connector 1202, when a force F (i.e., a force in the proximal direction) applied to the proximal connector 1214 is less than or equal to a predetermined proximal threshold (pull-off) force, the stop portions 1209 of the first arm 1211 and the second arm 1213 engage a plurality of notches 1282 to prevent the mating connector 1202 from separating from the distal connector 1212.

[0127] In some embodiments, the outer surface 1215 defined by the first arm 1211 and the second arm 1213 of the distal connector 1212 may have a slot 1250 that is at least partially recessed therein. The slot 1250 may have a linear surface 1251 that extends proximally from the distal end 1255 of the slot 1250, and a ramp surface 1254 that extends from the linear surface 1251 to the proximal end 1253 of the slot 1250. As shown, the ramp portion 1252 of each wing 1210 may be parallel to the ramp surface 1254 of each slot 1250, and the first linear portion 1266 of each wing 1210 may be parallel to the linear surface 1251 of each slot 1250. When a force F applied to the proximal connector 1214 exceeds a predetermined threshold, the stop 1209 may disengage from the notch 1282, causing the distal connector 1212 to translate distally relative to the proximal connector 1214. When the stop 1209 disengages from the notch 1282, the ramp surface 1254 of the slot 1250 may push against the ramp portion 1252 of the wing 1210 to pivot the first arm 1211 and the second arm 1213 radially outward and widen the open end 1225 of the distal connector 1212, thereby releasing the mating connector 1202 (as ​ shown).

[0128] In operation, the connector assembly 1201 may generally be coupled at its distal end to a mating or complementary connector 1202 and at its proximal end to a mating Luer connector 1203. In some embodiments, the mating or complementary connector 1202 may be a needleless connector, and the mating Luer connector 1203 may be a male Luer connector. For example, as ​ shown, the mating connector 1202 may be inserted and coupled to the open end 1225 of the distal connector 1212, and the mating Luer connector 1203 may be inserted and coupled to the inlet 1206 of the proximal connector 1214. In some embodiments, the mating connector 1202 may include threads 1239 for mating with complementary threads 1175 in the open end 1125 of the distal connector 1212. When the distal connector 1212 is connected to the mating connector 1202, at least one stop 1209 engages at least one notch 1282 to prevent the mating connector 1202 from separating from the distal connector 1212 when a predetermined proximal threshold (pull-out) force or less than the predetermined proximal threshold force is applied to the proximal connector 1214.

[0129] ​Shows the coupling configuration of the mating connector 1202 and the distal connector 1212 of the connector assembly 1201 when a force F that is less than or equal to a predetermined proximal threshold (pull-out) force is applied to the proximal connector 1214. For example, as described above with respect to the coupling device 100, the connector assembly 1201 may be subject to a pull-out force in the proximal direction due to a patient turning over in bed, a patient grasping a tube or pipeline on a bedrail, moving a patient to a different bed, a pediatric patient fidgeting, and / or an adult patient who is disoriented pulling on their pipeline. When subjected to a lower pull-out force, such as a force F that is less than or equal to a predetermined proximal threshold (pull-out) force, the connector assembly 1201 can be configured to hold the mating connector 1202 within the distal connector 1212 such that the fluid path 1238 remains open and a medical fluid, such as an IV fluid, can be administered from a fluid pipeline or tube 1217. Specifically, as ​ shown, when the distal connector 1212 is coupled to the mating connector 1202, the closed end 1246 of the post 1220 (along with the attached seal 1226) can be displaced away from the outlet port 1242 of the luer portion 1227 to permit flow through the fluid path 1238 via the luer portion 1227.

[0130] As shown, in the coupling configuration of the mating connector 112202 and the distal connector 1212, the luer portion 1227 can extend through the top surface 1207 of the mating connector 1202 into the mating luer of the mating connector 1202 to displace the flexible valve 1204 of the mating connector 1202. Thus, when the mating connector 1202 is coupled to the distal connector 1212, the mating connector 1202 can apply a force to push the plurality of arms 1222 of the post 1220 proximally, which in turn can cause the post 1220 to compress the compressible valve member 1218 proximally and displace the closed end 1246 of the post 1220 away from the outlet port 1242 of the luer portion 1227. Due to the compression, the slit 1274 at the distal end portion of the compressible valve member 1218 can open, thereby placing the internal chamber 1276 of the compressible valve member 1218 in fluid communication with the lumen 1228 of the post 1220 and permitting flow through the fluid path 1238 via the outlet port 1242 of the luer portion 1227 into the mating connector 1202. For example, as ​ shown, the top surface 1207 can force the plurality of arms 1222 and the post 1220 away from the outlet port 1242 of the luer portion 1227. In the open position, the closed end 1246 of the post 1220 is displaced from the outlet port 1242 of the luer portion 1227, thereby permitting medical fluid to flow between the outlet port 1242 of the luer portion 1227 and the lumen 1228 of the post 1220 through the channel 1248.

[0131] ​Illustrated is an operational view of the separation of the connector assembly 1201 from the mating connector 1202 due to the pivotal opening of the distal connector 1212 of the connector assembly 1201 when the connector assembly 1201 is subjected to a force F in the proximal direction that is higher than a predetermined threshold, in accordance with some embodiments of the present disclosure. In accordance with various embodiments of the present disclosure, when subjected to a higher pull-out force, such as a force F that exceeds a predetermined proximal threshold (pull-out) force, the connector assembly 1201 may be configured to release or otherwise separate the mating connector 1202 from within the distal connector 1212, at which time the fluid path 1238 may be closed and medical fluid (e.g., IV fluid) may no longer continue to enter the fluid line or fitting 217. As described above, the predetermined proximal threshold (pull-out force) may be approximately 5 lb.

[0132] Specifically, as ​ shown, when the force applied to the proximal connector 1214 exceeds a predetermined threshold, the stop 1209 may disengage from the notch 1282 to allow the distal connector 1212 to translate distally relative to the proximal connector 1214 and pivot radially outward the first arm 1211 and the second arm 1213, thereby separating the mating connector 1202 from the distal connector 1212, which will be described in further detail below. For example, in operation, when the proximal pull-out force F applied to the proximal connector 1214 exceeds a predetermined threshold, the pull-out force F may cause the stops 1209 of the first arm 1211 and the second arm 1213 to disengage or otherwise shift from the notches 1282 of the wings 1210. When the stop 1209 disengages from the notch 1282, the compressed valve member 1218 may expand and correspondingly move the post 1220 distally. When the post 1220 moves distally, the protrusions 1224 on each of the plurality of arms 1222 of the post 1220 may apply a distal force on the respective stops 1230 adjacent thereto, thereby causing the distal connector 1212 to move or translate distally. In particular, as ​As shown, as the compressible valve member 1218 expands, the first linear portion 1266 of each wing 1210 can slide along the linear surface 1251 of the slot 1250 to allow the distal connector 1212 to translate distally relative to the proximal connector 1214. As each wing 1210 continues to slide along the linear surface 1251 of each slot 1250 until the ramp surface 1254 of each slot 1250 contacts and abuts the ramp portion 1252 of each wing 1210, the distal connector 1212 can continue to translate distally. As the compressible valve member 1218 continues to expand, the ramp surface 1254 of each slot 1250 can push against the ramp portion 1252 of the wing 1210 to pivot the first arm 1211 and the second arm 1213 radially outward and widen the opening at the open end 1225 of the distal connector 1212. As the compressible valve member 1218 continues to expand distally, the compressible valve member 1218 can continue to apply a force on the post 1220 that moves or otherwise displaces the closed end 1246 of the post 1220 toward the outlet port 1242 of the luer portion 1227 to seal the outlet port 1242.

[0133] As shown, when the first arm 1211 and the second arm 1213 can continue to pivot radially outward, the mating connector 1202 can then be released and completely separated from the distal connector 1212. In this state, the outlet port 1242 of the luer portion 1227 is sealed by the seal 1226 at the closed end 1246 of the post 1220, thereby closing the fluid path 1238 and advantageously preventing microorganisms from entering the fluid path 1238. More advantageously, when the mating connector 1202 is disconnected, the sealed outlet port 1242 can prevent medical fluid (e.g., IV fluid) from further flowing out or otherwise spilling out of the fluid path 238 via the outlet port 1242 of the luer portion 1227.

[0134] Accordingly, the first arm 1211 and the second arm 1213 are advantageously designed to release the mating needleless connector 1202 when a pulling force F exceeding a threshold pulling force is applied to the fitting 1217 and the proximal connector 214. In this way, the connector assembly 1201 (such as, but not limited to, the Texium valve) and the mating connector 1202 (such as, but not limited to, the Smartsite valve) can automatically close when separated, thereby preventing (i) microorganisms from entering the fluid path 138, and (2) leakage or spillage of medical fluid in the event of accidental disconnection due to a higher pulling force exceeding a predetermined threshold force. The above configuration is superior to existing catheter dislodgment devices or couplings, which may or may not be adhesive-based and can only prevent catheter dislodgment at lower pulling forces. These existing catheter dislodgment devices or couplings cannot prevent catheter dislodgment at higher pulling forces, but may release in response to a higher pulling force (such as a force exceeding 5 lb), which is experienced during a patient turning over in bed, a patient grasping the fitting or tubing on the bedrail, moving the patient to a different bed, a pediatric patient fidgeting, and / or an adult patient with a sense of disorientation pulling on their tubing.

[0135] ​ An operational cross-sectional view of the proximal connector 1214 of the connector assembly 1201 according to some embodiments of the present disclosure is shown, the proximal connector being separated from the connector assembly 1201 for scrubbing. ​ An operational cross-sectional view of the proximal connector 1214 of the connector assembly according to some embodiments of the present disclosure is shown, the proximal connector being coupled to the remainder of the connector assembly 1201 after scrubbing. According to various embodiments of the present disclosure, by clamping the first arm 1211 and the second arm 1213 together or otherwise applying forces in opposite directions to pivot the first arm 1211 and the second arm 1213 radially inward to their initial state before pivoting radially outward, the first arm 1211 and the second arm 1213 of the distal connector 1212 can be returned from ​ the pivoted state shown to ​ the non-pivoted state shown.

[0136] As ​As shown, the proximal connector 1214 can be separated or detached from the remainder of the connector assembly 1201. For example, in the coupled or assembled configuration of the connector assembly 1201, the proximal connector can be coupled within the cavity 1208 of the body portion 1205. As shown, the inner surface of the body portion 1205 can include a plurality of threads 1290, and the outer surface of the proximal connector 214 can include complementary threads 1292 for engaging the threads 1290 of the body portion. To separate or detach the proximal connector 1214 from the remainder of the connector assembly 1201, the proximal connector 1214 can be unscrewed or removed from the cavity 1208 of the body portion 1205. Although the separation of the proximal connector 1214 from the remainder of the connector assembly 1201 is described herein with respect to threaded engagement, the various embodiments are not limited to the foregoing configuration, and the proximal connector 1214 can alternatively be removably coupled to the body portion by any other suitable coupling or fastening method.

[0137] An advantage of the above-described configuration in which the proximal connector 1214 is removably coupled to the remainder of the connector assembly is that the luer portion of the proximal connector 1214 can be scrubbed or otherwise sterilized after being removed from the cavity 1208 of the body portion 1205. In some embodiments, the remainder of the connector assembly 1201 (i.e., the body portion 1205 and the distal connector 1212 assembly) can be discarded and replaced with a new sterile body portion 1205 and distal connector 1212 assembly without disrupting or otherwise contaminating the fluid path 1238. As ​ shown, the proximal connector 1214 can then be attached or coupled to the new sterile body portion 1205 and distal connector 1212 assembly.

[0138] Similarly, when separated or otherwise detached from the connector assembly 1201, the mating connector 1202 can also be scrubbed or otherwise sterilized. As ​As shown, the mating connector 1202 can then be reconnected to the connector assembly 1201. For example, after the mating connector 1202 is sterilized, the mating connector 1202 can then be coupled or connected to a new sterile connector assembly 1201. The mating connector 1202 can be advanced toward the luer portion 1227 of the distal connector 1212. As the mating connector 1202 is advanced toward the luer portion 1227 of the distal connector 1212, the luer portion 1227 can be advanced into the interior of the mating connector 1202 and compress the valve member 1204 of the mating connector 1202. As the luer portion 1227 is further advanced into the interior of the mating connector 1202, the top surface 1207 of the mating connector 1202 can apply a force to push the multiple arms 1222 of the post 1220 proximally, which in turn can compress the compressible valve member 1218 and displace the closed end 1246 of the post 1220 away from the outlet port 1242 of the luer portion 1227, as ​ shown. For example, as previously described, by the engagement of the distal end portion 1223 of the arm 1222 against the top surface 1207 of the mating connector 1202, the multiple arms 1222 and the post 1220 can be forced away from the outlet port 1242 of the luer portion 1227. In the open position, the closed end 1246 of the post 1220 is displaced from the outlet port 1242 of the luer portion 1227, thereby reopening the fluid path 1238 and permitting medical fluid to flow through the outlet port 1242 of the luer portion 1227 and into the mating connector 1202 via the lumen 1228 and the channel 1248 of the post 1220. Accordingly, the administration of IV fluid from the fluid line or fitting 1217 to the catheter 1221B via the new sterile connector assembly 1201 can be restored.

[0139] Accordingly, the present disclosure provides features of a coupling device that can provide effective and safe maintenance of a fluid connection, such as a connection for delivering medical fluid toward or away from a patient. Additionally, when a pulling force or tension is applied to the coupling device, the coupling device of the present disclosure can maintain the fluid connection by preventing an unintended disconnection, while also permitting the fluid connection to be disconnected when the pulling force or tension exceeds a threshold, thereby preventing injury to the patient or caregiver. Additionally, by permitting the coupling device to be reconnected to the fluid delivery device, thereby reestablishing the fluid pathway, without the need to replace the coupling device, the coupling device of the present disclosure permits effective and safe reconnection of the fluid line.

[0140] Accordingly, the coupling device 100 can provide effective and safe maintenance of a fluid connection, can maintain the fluid connection of a medical fitting, and can permit disconnection and reconnection of the fluid path to and from a patient.

[0141] Exemplary terms of the present technology

[0142] For example, the present subject matter technology will be described in terms of various aspects described below. For convenience, various examples of aspects of the present subject matter technology are described in numbered clauses (1, 2, 3, etc.). These are provided as examples and do not limit the present subject matter technology. It should be noted that any dependent clauses can be combined in any combination and placed in the corresponding independent clauses (e.g., clause 1, clause 11, clause 17, clause 23, clause 26, or clause 29). Other clauses can be presented in a similar manner.

[0143] Clause 1. A fluid connector assembly, comprising: a first connector having a first housing, a second connector configured to be coupled to the first connector, the second connector having a second housing, a connection mechanism disposed on at least one of the first connector and the second connector for removably coupling the first connector and the second connector, wherein when a predetermined tensile force is applied to at least one of the first connector and the second connector, the connection mechanism disengages, thereby allowing the first connector and the second connector to separate, and wherein when the first connector and the second connector separate, an inner surface of one of the first connector and the second connector is exposed, thereby allowing disinfection.

[0144] Clause 2. The fluid connector assembly as described above, wherein the connection mechanism includes a first connection member coupled to one of the first connector or the second connector.

[0145] Clause 3. The fluid connector assembly as described above, wherein the first connection member includes a protrusion member disposed at a first end of the first connection member.

[0146] Clause 4. The fluid connector assembly as described above, further comprising a second connection member, and wherein the first connection member is coupled to the first connector and the second connection member is coupled to the second connector.

[0147] Clause 5. The fluid connector assembly as described above, wherein the second connection member includes a groove for receiving the protrusion member, and wherein when the first connector and the second connector are coupled, the first connection member and the second connection member are coupled such that the protrusion is received in the groove, and wherein when a predetermined force is applied, the first connection member and the second connection member separate.

[0148] Clause 6. The fluid connector assembly as described above, wherein the first connection member is a compression ring, and wherein the first connection member is flexible.

[0149] Clause 7. The fluid connector assembly as described above, wherein the second connection member further includes a groove for receiving the protrusion of the compression ring.

[0150] Clause 8. The fluid connector assembly as described above, wherein when the first connector and the second connector are coupled, the first connecting member and the second connecting member are coupled, and wherein when a predetermined force is applied, the first connecting member and the second connecting member are separated.

[0151] Clause 9. The fluid connector assembly as described above, wherein the protrusion is configured to engage the elastomeric ring, and wherein when a predetermined force is applied, the protrusion disengages from the elastomeric ring, thereby separating the first connector and the second connector.

[0152] Clause 10. The fluid connector assembly as described above, wherein the connecting member includes an elastic band and one or more engaging portions disposed around the first connector or the second connector, and wherein the elastic band is disposed around the one or more engaging portions.

[0153] Clause 11. The fluid connector assembly as described above, wherein the elastic band is configured to deflect until a predetermined threshold force is applied, and wherein when the predetermined threshold force is applied, the elastic band expands, allowing the one or more engaging portions to be pulled, thereby separating the first connector and the second connector.

[0154] Clause 12. A fluid connector assembly, comprising: a first connector having a first housing; a second connector configured to be coupled to the first connector, the second connector having a second housing; a connection mechanism disposed on at least one of the first connector and the second connector for removably coupling the first connector and the second connector, and wherein when a tensile force of a predetermined threshold is applied to one of the first connector and the second connector, the first connector and the second connector are separated.

[0155] Clause 13. The fluid connector assembly as described above, wherein the connection mechanism includes a first connecting member coupled to one of the first connector or the second connector.

[0156] Clause 14. The fluid connector assembly as described above, wherein the first connecting member includes a protrusion member disposed at a first end of the first connecting member.

[0157] Clause 15. The fluid connector assembly as described above, further comprising a second connecting member, and wherein the first connecting member is coupled to the first connector and the second connecting member is coupled to the second connector.

[0158] Clause 16. The fluid connector assembly as described above, wherein the second connecting member includes a groove for receiving the protrusion member, and wherein when the first connector and the second connector are coupled, the first connecting member and the second connecting member are coupled such that the protrusion is received in the groove, and wherein when a predetermined force is applied, the first connecting member and the second connecting member are separated.

[0159] Clause 17. The fluid connector assembly as described above, wherein the first connecting member is a compression ring and wherein the first connecting member is flexible.

[0160] Clause 18. The fluid connector assembly as described above, wherein the second connecting member further includes a groove for receiving the projection of the compression ring.

[0161] Clause 19. The fluid connector assembly as described above, wherein when the first connector and the second connector are coupled, the first connecting member and the second connecting member are coupled, and wherein when a predetermined force is applied, the first connecting member and the second connecting member are separated.

[0162] Clause 20. The fluid connector assembly as described above, wherein the projection is configured to engage the elastomeric ring and wherein when a predetermined force is applied, the projection disengages from the elastomeric ring, thereby separating the first connector and the second connector.

[0163] Clause 21. The fluid connector assembly as described above, wherein the connecting member includes an elastic band and one or more engaging portions disposed around the first connector or the second connector, and wherein the elastic band is disposed around the one or more engaging portions.

[0164] Clause 22. The fluid connector assembly as described above, wherein the elastic band is configured to deflect until a predetermined threshold force is applied, and wherein when the predetermined threshold force is applied, the elastic band expands, allowing the one or more engaging portions to be pulled, thereby separating the first connector and the second connector.

[0165] Clause 23. A fluid connector assembly, comprising: a first connector having a first housing; a second connector configured to be coupled to the first connector, the second connector having a first connector member and a second connector member; a connecting mechanism disposed on at least one of the first connector and the second connector for removably coupling the first connector and the second connector, wherein when a tensile force of a predetermined threshold is applied to one of the first connector and the second connector, the first connector and the second connector are separated, and wherein when the first connector and the second connector are separated, the first connector member is separable from the second connector member.

[0166] Further Considerations

[0167] In some embodiments, any one of the clauses herein can be subordinate to any one of the independent clauses or any one of the dependent clauses. In one aspect, any clause (e.g., a dependent or independent clause) can be combined with any other one or more clauses (e.g., a dependent or independent clause). In one aspect, the claims can include some or all of the words (e.g., steps, operations, means, or components) recited in a clause, sentence, phrase, or paragraph. In one aspect, the claims can include some or all of the words recited in one or more clauses, sentences, phrases, or paragraphs. In one aspect, some words in each clause, sentence, phrase, or paragraph can be removed. In one aspect, additional words or elements can be added to the clause, sentence, phrase, or paragraph. In one aspect, the subject technology can be implemented without utilizing some of the components, elements, functions, or operations described herein. In one aspect, additional components, elements, functions, or operations can be utilized to implement the subject technology.

[0168] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0169] Unless otherwise specified, an element recited in the singular form is not intended to mean "one and only one" but rather "one or more." Unless otherwise specified, the term "some" means one or more. Masculine pronouns (such as "his") include feminine and neuter genders (such as "her" and "its"), and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

[0170] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as more preferred or advantageous than other aspects or designs. In one aspect, the various alternative configurations and operations described herein can be considered to be at least equivalent.

[0171] Phrases such as "aspect" do not imply that such an aspect is necessary for the claimed technology or that such an aspect applies to all configurations of the claimed technology. The disclosure associated with an aspect can apply to all configurations, or one or more configurations. An aspect can provide one or more examples. Phrases such as aspect can refer to one or more aspects and vice versa. Phrases such as "embodiment" do not imply that such an embodiment is necessary for the claimed technology or that such an embodiment applies to all configurations of the claimed technology. The disclosure associated with an embodiment can apply to all embodiments, or one or more embodiments. An embodiment can provide one or more examples. Such phrases of an embodiment can refer to one or more embodiments and vice versa. Phrases such as "configuration" do not imply that such a configuration is necessary for the claimed technology or that such a configuration applies to all configurations of the claimed technology. The disclosure associated with a configuration can apply to all configurations or one or more configurations. A configuration can provide one or more examples. Such a configuration can refer to one or more configurations and vice versa.

[0172] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including those in the following claims, are approximate and not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they pertain and the conventions of the field to which they belong.

[0173] In one aspect, terms such as "coupled" can refer to direct coupling. In another aspect, terms such as "coupled" can refer to indirect coupling.

[0174] Terms such as "top", "bottom", "front", "rear", etc., if used in this disclosure, should be understood to refer to any reference frame and not to the ordinary gravitational reference frame. Thus, a top surface, a bottom surface, a front surface, and a rear surface can extend upward, downward, diagonally, or horizontally in the gravitational reference frame.

[0175] The various items can be arranged differently (e.g., in a different order or divided in a different manner), all of which do not depart from the scope of the subject technology. All structural and functional equivalents of the elements of the various aspects described throughout this disclosure that are known or will later be known to those of ordinary skill in the art are hereby expressly incorporated by reference and are intended to be covered by the claims. In addition, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element shall be construed under the provisions of 35 U.S.C. § 112, sixth paragraph, unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "step for". Further, with respect to the scope of the terms "comprising", "having", etc. used, such terms are intended to be open-ended in a manner similar to the term "including" as interpreted when "including" is used as a transitional word in a claim.

[0176] The title, background, overview, brief description of the drawings, and abstract of this disclosure are hereby incorporated into this disclosure and provided as illustrative examples of this disclosure, rather than as restrictive descriptions. It should be understood when filing this application that they will not be used to limit the scope or meaning of the claims. Further, in the detailed description, it can be seen that the description provides illustrative examples and, for the purpose of streamlining this disclosure, various features are combined together in individual embodiments. The methods of this disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as reflected in the following claims, the inventive subject matter lies in less than all of the features of a single disclosed construction or operation. The following claims are hereby incorporated into the detailed description, with each claim standing alone as a separately claimed subject matter.

[0177] The claims are not intended to be limited to the aspects described herein, but rather conform to the full scope consistent with the language of the claims and cover all legal equivalents. Nevertheless, no claim is intended to cover subject matter that fails to meet the requirements of 35 U.S.C. § 101, 102, or 103, nor should they be construed in such a way.

Claims

1. A fluid connector assembly, comprising: a first connector having a first housing, a second connector configured to be coupled to the first connector, the second connector having a second housing, a connection mechanism disposed on at least one of the first connector and the second connector for removably coupling the first connector and the second connector, wherein when a predetermined tensile force is applied to at least one of the first connector and the second connector, the connection mechanism disengages, thereby allowing the first connector and the second connector to separate, and wherein when the first connector and the second connector separate, an inner surface of one of the first connectors is exposed, thereby allowing disinfection.

2. The fluid connector assembly according to claim 1, wherein, The connection mechanism includes a first connection member coupled to one of the first connector or the second connector.

3. The fluid connector assembly according to claim 2, wherein, The first connection member includes a protrusion member disposed at a first end of the first connection member.

4. The fluid connector assembly according to claim 2, further comprising a second connection member, and Among them, the first connection member is coupled to the first connector, and the second connection member is coupled to the second connector.

5. The fluid connector assembly according to claim 4, wherein, The second connection member includes a groove for receiving the protrusion member, wherein when the first connector and the second connector are coupled, the first connection member and the second connection member are coupled such that the protrusion is received within the groove, and wherein when a predetermined force is applied, the first connection member and the second connection member separate.

6. The fluid connector assembly according to claim 4, wherein, The first connection member is a compression ring, and wherein the first connection member is flexible.

7. The fluid connector assembly according to claim 6, wherein, The second connection member further includes a groove for receiving a protrusion of the compression ring.

8. The fluid connector assembly according to claim 4, wherein, When the first connector and the second connector are coupled, the first connection member and the second connection member are coupled, and wherein when a predetermined force is applied, the first connection member and the second connection member separate.

9. The fluid connector assembly according to claim 3, wherein, The protrusion is configured to engage an elastomeric ring, and wherein when a predetermined force is applied, the protrusion disengages from the elastomeric ring, thereby separating the first connector and the second connector.

10. The fluid connector assembly according to claim 1, wherein, The connection member includes an elastic band and one or more engagement portions disposed around the first connector or the second connector, and wherein the elastic band is disposed to surround the one or more engagement portions.

11. The fluid connector assembly according to claim 10, wherein, The elastic band is configured to deflect until a predetermined threshold force is applied, and wherein when the predetermined threshold force is applied, the elastic band expands, allowing the one or more engagement portions to be pulled, thereby separating the first connector and the second connector.

12. A fluid connector assembly, comprising: a first connector having a first housing; a second connector configured to be coupled to the first connector, the second connector having a second housing; a connection mechanism disposed on at least one of the first connector and the second connector for removably coupling the first connector and the second connector, and Wherein, when a pulling force of a predetermined threshold is applied to one of the first connector and the second connector, the first connector and the second connector are separated.

13. The fluid connector assembly according to claim 12, wherein, The connecting mechanism includes a first connecting member coupled to one of the first connector or the second connector.

14. The fluid connector assembly according to claim 13, wherein, The first connecting member includes a protruding member provided at a first end of the first connecting member.

15. The fluid connector assembly according to claim 13, further comprising a second connecting member, and Among them, The first connecting member is coupled to the first connector, and the second connecting member is coupled to the second connector.

16. The fluid connector assembly according to claim 15, wherein, The second connecting member includes a groove for receiving the protruding member, Wherein, when the first connector and the second connector are coupled, the first connecting member and the second connecting member are coupled such that the protrusion is received within the groove, and Wherein, when a predetermined force is applied, the first connecting member and the second connecting member are separated.

17. The fluid connector assembly according to claim 15, wherein, The first connecting member is a compression ring, and Wherein, the first connecting member is flexible.

18. The fluid connector assembly according to claim 17, wherein, The second connecting member further includes a groove for receiving the protrusion of the compression ring.

19. The fluid connector assembly according to claim 15, wherein, When the first connector and the second connector are coupled, the first connecting member and the second connecting member are coupled, and Wherein, when a predetermined force is applied, the first connecting member and the second connecting member are separated.

20. The fluid connector assembly according to claim 14, wherein, The protrusion is configured to engage an elastomeric ring, and Wherein, when a predetermined force is applied, the protrusion disengages from the elastomeric ring, thereby separating the first connector and the second connector.

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