Connector / Coupler Assembly

Abstract

The coupler may include a coupler body including a first end, a second end, an outer surface, an inner surface defining a cavity, and a wall defined between the inner surface and the outer surface; a plurality of first retention fingers disposed adjacent the first end and extending radially inward into the cavity; and a mounting hole defined between a free end of each first retention finger and the wall. The cavity may be configured to receive the first connector and the second connector. The plurality of first retention fingers may be biased radially inward toward the cavity and configured to abut and engage with a collar of the first connector to prevent axial movement of the first connector relative to the coupler. The mounting hole may be configured to receive a pivot shaft of the collar to pivotally couple the first connector relative to a central axis of the coupler body.

Description

[Technical Field]

[0001] The present disclosure relates generally to connectors, and more particularly to connector couplers. [Background technology]

[0002] Medical procedures often involve the infusion of medical fluids (e.g., saline or liquid medications) into a patient using intravenous (IV) catheters, which are connected to a source of fluid, such as an IV bag, through an arrangement of flexible tubing and fittings commonly referred to as an “IV set.” Often, the tubing or catheters are joined or secured together to allow fluid communication between various portions of the tubing or catheter.

[0003] In some applications, such tubing or catheters may become dislodged due to improper fixation and / or when the coupler is subjected to forces that exceed those it is designed to withstand. Summary of the Invention

[0004] Described herein are embodiments of couplers. In some embodiments, the coupler includes: a coupler body including a first end, a second end, an outer surface, an inner surface defining a cavity, and a wall defined between the inner surface and the outer surface, the cavity configured to receive a first connector and a second connector; a plurality of first retention fingers disposed adjacent the first end and extending radially inward into the cavity, the plurality of first retention fingers being biased radially inward toward the cavity and configured to abut and engage a collar of the first connector to prevent axial movement of the first connector relative to the coupler; and a mounting hole defined between a free end of each first retention finger and the wall, the mounting hole configured to receive a pivot shaft of the collar of the first connector to pivotally couple the first connector relative to a central axis of the coupler body.

[0005] In some embodiments described herein, a coupler assembly includes a first connector including a first connector body having a first inlet configured to be coupled to a first portion of tubing and a first outlet in fluid communication with the first inlet, a collar sleeved over the first connector body between the first inlet and the first outlet, the collar including a body including a pivot shaft extending radially outward from the collar body opposite the collar body, and a coupler having a first end, a second end, an inner surface defining a cavity, an outer surface, and a wall defined between the inner and outer surfaces. and a coupler including a coupler body having a first end and a plurality of first retention fingers disposed adjacent the first end and extending radially inward into the cavity, the plurality of first retention fingers being biased radially inward toward the cavity and configured to abut and engage the collar to prevent axial movement of the first connector relative to the coupler; and a mounting hole defined between a free end of each first retention finger and the wall, the mounting hole being configured to receive a pivot shaft of the collar to pivotally couple the first connector to the coupler body.

[0006] Some embodiments include a proximal connector defining an inlet port and having an inner surface defining a cavity in the proximal connector and an outer surface including at least one notch recessed therein; a distal connector comprising first and second arms pivotally coupled to one another and slidably coupled to the proximal connector; an outer surface; an inner surface defining a cavity terminating in an open end of the distal connector, the inner surface including at least one detent and at least one stop extending radially inward from the inner surface; a luer portion extending through the open end into the cavity, a flow path extending from the inlet port through the luer portion to an outlet port of the luer portion; and a plurality of wings extending from the outer surface of the proximal connector to the outer surface of the distal connector. and a root, wherein the distal connector is slidably coupled to the proximal connector via a plurality of wings, and when the distal connector is coupled to the mating connector, the at least one detent engages with the at least one notch to prevent the mating connector from being decoupled from the distal connector below a predetermined proximal threshold force applied to the proximal connector, and when the force applied to the proximal connector exceeds the predetermined threshold, the at least one detent disengages from the at least one notch to allow the distal connector to translate distally relative to the proximal connector and pivot the first and second arms radially outward to decouple the mating connector from the distal connector.

[0007] It is to be understood that various configurations of the subject technology will be readily apparent to those skilled in the art from the disclosure, and that various configurations of the subject technology have been shown and described by way of illustration. As will be understood, the subject technology is capable of other and different configurations, and its several details are capable of modifications in various other respects, all without departing from the scope of the subject technology. Accordingly, the summary, drawings, and detailed description are to be regarded as illustrative in nature, and not as restrictive.

[0008] The accompanying drawings are included to provide a further understanding, are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure, and together with the description, serve to explain the principles of the disclosed embodiments. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 is a perspective view of a coupler assembly according to various aspects of the present disclosure. [Figure 2] FIG. 1 is an exploded perspective view of a coupler and an assembled first connector and second connector according to some embodiments of the present disclosure. [Figure 3] 2 is an exploded perspective view of the coupler assembly of FIG. 1 with the second connector omitted, according to some embodiments of the present disclosure. [Figure 4] FIG. 2 is an exploded perspective view of the coupler assembly of FIG. 1 according to some embodiments of the present disclosure. [Figure 5] 2 is a perspective view of the coupler assembly of FIG. 1 with a first connector of the coupler assembly pivoted relative to a coupler of the coupler assembly, according to some embodiments of the present disclosure. [Figure 6] FIG. 1 is an exploded perspective view of a first connector with a collar according to some embodiments of the present disclosure. [Figure 7] FIG. 1 is an assembled perspective view of a first connector with a collar according to some embodiments of the present disclosure. [Figure 8] 2 is a perspective view of the coupler assembly of FIG. 1 with the coupler partially cut away, according to some embodiments of the present disclosure. [Figure 9] FIG. 1 is a perspective view of an extension set including a connector assembly according to some embodiments of the present disclosure. [Figure 10A] 1A-1C are diagrams of a connector assembly coupled with a mating needleless connector according to some embodiments of the present disclosure. [Figure 10B] 10A-10C are cross-sectional operational views of a connector assembly with a mating needleless connector when subjected to a proximally directed force below a predetermined threshold, according to some embodiments of the present disclosure. [Figure 10C]FIG. 10 is a cross-sectional operational view of a connector assembly with a mating needleless connector, in which a proximally directed force exceeding a predetermined threshold causes the distal connector to pivot open and seal the flow path, according to some embodiments of the present disclosure. [Figure 10D] 1A-1C are cross-sectional operational views of a connector assembly being disconnected from a mating needleless connector according to some embodiments of the present disclosure. [Figure 10E] 12A and 12B are cross-sectional operational views of the connector assembly with the first and second arms of the distal connector returned to a non-pivoting state, according to some embodiments of the present disclosure. [Figure 10F] 1 is a cross-sectional operational view of a connector assembly with a mating needleless connector advanced toward the connector assembly to make initial contact, according to some embodiments of the present disclosure. [Figure 10G] 10A-10C are cross-sectional operational views of a connector assembly with a mating needleless connector partially inserted into the distal connector, according to some embodiments of the present disclosure. [Figure 10H] 10A-10C are cross-sectional operational views of a connector assembly with a mating needleless connector inserted into the distal connector and moving a post to open a flow path, according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0010] The disclosed coupler incorporates a plurality of first retention fingers and a plurality of second retention fingers. The plurality of first retention fingers can be configured to abut and engage with a collar of the first connector to prevent axial movement of the first connector. The plurality of second retention fingers can be configured to abut and engage with a shoulder of the second connector to prevent axial movement of the second connector. By preventing axial movement of the first and second connectors, the coupler can prevent unintentional or accidental disconnection of the first and second connectors. Furthermore, the plurality of second retention fingers can be configured to release the second connector in response to a withdrawal force. By allowing the second connector to be removed in response to a withdrawal force, the second connector can be removed by applying an increased withdrawal force as needed.

[0011] The disclosed connector assembly incorporates a proximal connector configured to be coupled to a medical fluid source and a distal connector slidably coupled to the proximal connector via a plurality of wings and configured to couple to a mating needleless connector. The proximal connector may include a spring member mounted therein and coupled to a post and at least one notch on an outer surface thereof. The distal connector may include a luer portion, with the distal end of the post extending into the luer portion. The distal connector may further include first and second arms pivotally or hingedly coupled to one another and at least one detent on an inner surface thereof for engaging the at least one notch. When a force applied to the proximal connector (e.g., a high withdrawal force) exceeds a predetermined threshold, the at least one detent may disengage from the at least one notch, thereby allowing the distal connector to translate distally relative to the proximal connector and pivot the first and second arms radially outward to decouple the mating connector from the distal connector. When the at least one detent disengages from the at least one notch, the compressed spring may expand, correspondingly moving the post distally. As the post moves distally, protrusions on the arms of the post exert a distal force on the corresponding arms of the distal connector, thereby moving or translating the distal connector distally. In particular, as the spring member expands, each of the wings slides along a slot in each of the first and second arms, allowing the distal connector to translate distally relative to the proximal connector. As the spring member 218 continues to expand, the angled surfaces of each of the slots may abut and press against the ramp portions of the wings, causing the first and second arms to pivot radially outward and spread the open ends of the distal connector. As the spring continues to expand distally, the spring member may continue to exert a force on the post, which moves or otherwise biases the closed end of the post toward the exit port of the luer portion to seal the exit port.

[0012] As the first and second arms continue to pivot radially outward, the mating connector may then be released and completely disconnected from the distal connector. In this state, the outlet port of the luer portion may be sealed by a seal at the closed end of the post, thereby closing the flow path and preventing medical fluid, such as IV fluid, from escaping or otherwise spilling upon accidental disconnection. Thus, the first and second arms are advantageously designed to release the mating needleless connector upon application of a pulling force exceeding a threshold pulling force. Thus, both the connector assembly (e.g., but not limited to, a Texium valve) and the mating connector (e.g., but not limited to, a Smartsite valve) may automatically shut off when pulled apart, thereby preventing leakage or spillage of medical fluid upon accidental disconnection due to higher withdrawal forces above a predetermined threshold force.

[0013] The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology. Similar components are labeled with the same element numbers for ease of understanding. Reference numbers may have a suffixed letter to indicate separate instances of common elements, while being generically referenced by the same number without the suffix.

[0014] While the following description is directed to connecting medical fittings for the administration of medical fluids using the disclosed couplers, it should be understood that this description is merely an example of use and is not intended to limit the scope of the claims. Various aspects of the disclosed couplers may be used in any application where it is desirable to securely connect various tubing and fittings.

[0015] The disclosed couplers overcome several problems found with certain conventional couplers. One problem with certain conventional couplers is that they may be improperly secured. Furthermore, during use, certain conventional couplers may be designed to release or disengage in response to a relatively small withdrawal force. For example, certain conventional couplers may release in response to withdrawal forces experienced when a patient turns in bed, when a patient catches the tubing or line on a bed rail, when a patient is moved to a different bed, when a pediatric patient fumbles, and / or when a confused adult patient withdraws their line. Indeed, the 2017 Vascular Access Association (AVA) Annual Meeting reported a 10% dislodgement rate per 1,000 patients fitted with peripheral IV catheters, translating to approximately 33 million dislodgements per year in the United States alone. Accidental or unintentional dislodgement of tubing, catheters, or fittings can interrupt the administration of medical fluids, making the use of certain conventional couplers undesirable.

[0016] Therefore, in accordance with the present disclosure, it would be advantageous to provide couplers and coupler / connector assemblies as described herein that allow for improved securement of fittings or connectors. The disclosed couplers and coupler / connector assemblies are constructed as described herein to allow for secure retention of the connector while allowing for intentional removal of the connector if desired.

[0017] Figure 1 is a perspective view of a coupler assembly 100 according to various aspects of the present disclosure. Figure 2 is an exploded perspective view of a coupler, an assembled first connector assembly, and a second connector according to some embodiments of the present disclosure. Figure 3 is an exploded perspective view of the coupler assembly 100 of Figure 1 with the second connector 130 omitted according to some embodiments of the present disclosure.

[0018] 1-3 , coupler assembly 100 enables the flow of fluid, such as medical fluid, from a fluid source to a patient by releasably coupling a section of tubing or line with another section of tubing or line in fluid communication. In the depicted example, the section of tubing may terminate in a connector, such as first connector 110 and / or second connector 130. First connector 110 and / or second connector 130 may enable connection and / or disconnection of the tubing to enable selective fluid communication therebetween.

[0019] As illustrated, a first section of tubing can be terminated by a first connector 110, allowing the first section of tubing to be connected and / or disconnected with a mating connector, such as a second connector 130. In some embodiments, a section of tubing can be coupled or engaged with an inlet 112 of the first connector 110. The inlet 112 can be in fluid communication with the tubing, allowing fluid to pass through the first connector 110. In some embodiments, the inlet 112 can have a flat surface to allow a clinician to easily clean and disinfect the inlet 112. Fluid can exit or flow through the first connector 110 via an outlet 114 located opposite the inlet 112. The fluid flow path through the first connector 110 can have a straight fluid path to facilitate rapid flow and reduce the risk of hemolysis. Optionally, the first connector 110 can include a raised feature 122 located on an outer surface of the first connector 110 to allow a clinician to more easily handle or manipulate the first connector 110. Some embodiments of the first connector 110 can provide a connector that is compatible with connectors on other portions of the fluid delivery system. Examples of the first connector 110 can include a SmartSite™ connector, a Max Zero connector, and a MaxPlus connector.

[0020] Similarly, the second section of tubing can be terminated by a second connector 130 to allow the second section of tubing to be connected and / or disconnected with a mating connector, such as the first connector 110. In some embodiments, the section of tubing can be coupled or engaged with an outlet 134 of the second connector 130. In some embodiments, the outlet 134 can include a threaded luer connection 138 to facilitate coupling of the tubing.

[0021] The tubing can be in fluid communication with the outlet 134, allowing the tubing to receive fluid passing through the second connector 130. The second connector 130 can receive fluid flow from an inlet 132 disposed opposite the outlet 134. In some embodiments, the second connector 130 can include an anti-drip feature to prevent leakage or surface contamination. The second connector can further include a luer lock to prevent accidental release. Optionally, the second connector 130 can include a raised feature 140 disposed on an outer surface of the second connector 130 to allow a clinician to more easily handle or manipulate the second connector 130. An example of the second connector 130 can include a Texium® connector.

[0022] In some embodiments, the outlet 114 of the first connector 110 and / or the inlet 132 of the second connector 130 can include a feature that allows the outlet 114 to mate with the inlet 132. For example, the outlet 114 can mate with or otherwise engage the inlet 132 to allow fluid communication between the first connector 110, the second connector 130, and the portions of tubing coupled thereto. As can be appreciated, the first connector 110 and the second connector 130 can be coupled and uncoupled to allow fluid communication as desired. As illustrated, the outlet 114 can include a smooth and otherwise unthreaded outer portion. In some embodiments, the outlet 114 can include an outer portion that includes threads to facilitate coupling with the first connector 110. As can be appreciated, the first connector 110 can be coupled with the second connector 130 to provide a needle-free connection. Advantageously, the first connector 110 can mate with the second connector 130 to form a closed, leak-proof system to allow for the delivery of hazardous drugs. For example, a SmartSite™ connector can connect to a Texium® connector to provide a closed system that prevents hazardous drugs from leaking or dripping.

[0023] In some embodiments, first connector 110 can include a sealing valve to allow flow therethrough when outlet 114 is coupled to a mating connector and can prevent or restrict flow when first connector 110 is disconnected from the mating connector. In some embodiments, first connector 110 can include a sealing valve to seal the flow path between inlet 112 and outlet 114 when outlet 114 is disconnected from the mating connector. The sealing valve can be moved to an open position when the mating connector is coupled to outlet 114 and can allow flow between inlet 112 and outlet 114 and into the mating connector.

[0024] Similarly, second connector 130 can include a sealing valve to allow flow therethrough when inlet 132 is coupled to a mating connector, and can prevent or restrict flow when second connector 130 is disconnected from the mating connector. Second connector 130 may include a sealing valve to seal the flow path between inlet 132 and outlet 134 when inlet 132 is disconnected from the mating connector. Furthermore, the sealing valve can be moved to an open position when a mating connector is coupled to inlet 132, allowing flow into second connector 130 and between inlet 132 and outlet 134. In some embodiments, a portion of the sealing valve can be formed from silicone.

[0025] 1 , the coupler assembly can include a coupler having a body 150 that secures the first connector 110 and the second connector 130 in a coupled position, thereby enabling reliable fluid communication therebetween that cannot be accidentally or unintentionally interrupted. In the depicted example, the coupler body 150 can retain or secure the first connector 110 and / or the second connector 130 by engaging features of the first connector 110 and / or the second connector 130.

[0026] According to various embodiments of the present disclosure, coupler body 150 may include a first end 151, a second end 161, an outer surface 163, and an inner surface 119 that defines a cavity 155 of coupler body 150. Coupler body 150 may further include a wall 167 defined between inner surface 119 and outer surface 163. As illustrated, coupler body 150 may have a generally tubular body extending between first end 151 configured to receive first connector 110 and second end 161 configured to receive second connector 130. Coupler body 150 may define cavity 155 therein, which allows a portion of first connector 110 and / or second connector 130 to be disposed within coupler body 150.

[0027] In the depicted example, the first connector 110 can be inserted into a cavity 155 of the coupler body 150 to mate with the coupler body 150 and prevent undesired disengagement of the first connector 110. As illustrated, the outlet 114 of the first connector 110 is guided into the cavity 155 through a first end 151 of the coupler body 150 to a desired axial position relative to the coupler body 150. For example, the first connector 110 can be axially positioned within the coupler body 150 to allow the outlet 114 to engage or mate with the inlet 132 of the second connector 130 when the second connector 130 is inserted. Advantageously, the first connector 110 can be axially positioned within the coupler body 150 such that the outlet 114 is recessed within the cavity 155 to prevent contact contamination of the outlet 114 by the patient, clinician, etc. when the first connector 110 is not coupled to the second connector 130.

[0028] In some embodiments, a feature within coupler body 150 can position first connector 110 within cavity 155 of coupler body 150. Optionally, coupler body 150 can include a tapered alignment feature to generally radially align outlet 114 and / or first connector 110 within the cavity of coupler body 150. The tapered alignment feature can extend from a wall of coupler body 150 into the cavity and can have a generally conical shape that converges radially. Thus, when first connector 110 is inserted or advanced into coupler body 150, the tapered alignment feature can guide first connector 110 radially into the cavity.

[0029] 4 is an exploded perspective view of the coupler assembly 100 of FIG. 1 according to some embodiments of the present disclosure. In some embodiments, the first connector 110 may include a frustoconical or tapered portion 120 to engage or couple with a tapered alignment feature 162 of the coupler body 150. The tapered portion 120 may slide along the tapered alignment feature 162 to radially align the first connector 110 within the coupler body 150. The tapered portion 120 may be disposed between the inlet 112 and the outlet 114 of the first connector 110. In some embodiments, the tapered portion 120 may be disposed near the outlet 114 of the first connector 110.

[0030] When first connector 110 is inserted into coupler body 150, a feature of coupler body 150 can hold first connector 110 in the inserted position. In some embodiments, coupler body 150 can hold first connector 110 axially while allowing first connector 110 to rotate relative to coupler body 150, for example, rotate about the X-axis. Optionally, coupler body 150 can hold first connector 110 rotatably relative to coupler body 150.

[0031] In the depicted example, coupler body 150 may include a plurality of first retention fingers 152 to engage or retain first connector 110 in an inserted or coupled axial position. In some embodiments, the plurality of first retention fingers 152 are radially movable to allow first connector 110 to be inserted into coupler body 150. The plurality of first retention fingers 152 may be movable into and out of a cavity defined by coupler body 150. In some embodiments, coupler body 150 may further include a mounting hole 159 defined between a free end 157 of each first retention finger 152 and a wall 167 of coupler body 150.

[0032] As illustrated, the plurality of first retention fingers 152 may be hinged to the coupler body 150. In some embodiments, the plurality of first retention fingers 152 are integrally formed with the coupler body 150. Optionally, slots or windows 160 are cut around the material of the coupler body 150 to form the plurality of first retention fingers 152. The plurality of first retention fingers 152 may be spaced circumferentially around the coupler body 150. Optionally, the plurality of first retention fingers 152 may be arranged in groups or sets around the coupler body 150. In some embodiments, the plurality of first retention fingers 152 may be spaced apart from the first end 151 of the coupler body 150 that receives the first connector 110.

[0033] In the depicted example, the plurality of first retention fingers 152 may be biased radially inward to engage or retain the first connector 110 within the coupler body 150. In some embodiments, the plurality of first retention fingers 152 may exert a radial spring force on the first connector 110 to retain the first connector 110 within the coupler body 150. As can be appreciated, the spring force of the plurality of first retention fingers 152 may match the retention force exerted on the first connector 110. The plurality of first retention fingers 152 may resiliently deform to abut and engage the first connector 110.

[0034] 4 , each of the plurality of first retention fingers 152 may include a protrusion or protruding feature 153 for engaging with a feature of the first connector 110. The protruding feature 153 may be biased or extend radially inward to contact the first connector 110. For example, the plurality of first retention fingers 152 and / or the protruding feature 153 may abut and engage the ring 116 of the first connector 110.

[0035] FIG. 5 is a perspective view of the coupler assembly 100 of FIG. 1 with the first connector 110 of the coupler assembly 100 pivoted relative to the coupler body 150 of the coupler assembly 100, according to some embodiments of the present disclosure. FIG. 6 is an exploded perspective view of the first connector 110 with a collar 170, according to some embodiments of the present disclosure. FIG. 7 is an assembled perspective view of the first connector 110 with the collar 170, according to some embodiments of the present disclosure. As depicted in FIGS. 5 through 7 with continued reference to FIGS. 1 through 4 , in some embodiments, the first connector 110 may include a collar 170 that may be sleeved to cover at least a portion of the outer surface 117 of the first connector 110. For example, the collar 170 may be sleeved between the inlet 112 and the outlet 114 of the first connector 110. As illustrated, the collar 170 may be disposed in an intermediate portion between the inlet 112 and the outlet 114 of the first connector. In some embodiments, collar 170 may include a slot 171 extending longitudinally therethrough. Slot 171 may advantageously allow collar 170 to be more flexible for easier assembly or insertion into first connector 110. In some embodiments, collar 170 may be integrally formed with first connector 110. In some embodiments, collar 170 may be removably coupled to first connector 110. In some embodiments, collar 170 may have a central longitudinal axis Y, and first connector 110 may be rotatable about central longitudinal axis Y.

[0036] In some embodiments, the collar 170 may include a protrusion or pivot shaft 174 extending radially outward from an outer surface 172 of the collar 170. The pivot shaft 174 may be received in or rotatably engaged within the mounting hole 159 to allow the first connector 110, having the collar 170 either integrally formed therewith or removably coupled thereto, to pivot relative to the coupler body 150. For example, the pivot shaft 174 may be rotated within the mounting hole 159, thereby causing corresponding pivoting of the first connector 110 relative to the longitudinal axis of the coupler body 150. Advantageously, with the pivot shaft 174 mounted in the mounting hole 159, the first connector 110 may be pivoted, as illustrated in FIG. 5 , to allow for swabbing of a sterile portion of the first connector outlet 114. For example, in some embodiments, the first connector 110 may be pivoted approximately 90° about the longitudinal axis X of the coupler body 150. However, various embodiments of the present disclosure are not limited to the above configuration, and the first connector 110 may be pivotable at an angle ranging from approximately 45° to approximately 90°, and in some examples, from approximately 50° to 85°, from approximately 55° to approximately 80°, from approximately 60° to 75°, and from approximately 65° to approximately 70°. The second connector 130 may also be wiped and then reattached to resume flow. A coupler body 150 having multiple first retention fingers 152 and / or protruding features 153 can therefore advantageously prevent unintentional pivoting of the coupler body 150.

[0037] 6 and 7 , in some embodiments, coupler body 150 may further include a notch 164 extending longitudinally from first end 151 toward second end 161, and a window 165 extending through wall 167 and disposed on the opposite side of coupler body 150 from notch 164. As depicted, notch 164 and window 165 may be cooperatively configured such that, in a coupled configuration between coupler body 150 and first connector 110, first connector 110 is pivotable relative to coupler body 150 between a first position extending along a central longitudinal axis X of coupler body 150 and a second position extending through wall 167 via notch 164 and window 165 in a direction transverse to central longitudinal axis X of coupler body 150. Thus, when the first connector 110 is pivoted, the outlet 114 of the first connector 110 may extend and protrude outwardly from the coupler body 150 to facilitate access for wiping.

[0038] In some embodiments, the first connector 110 may include a ring 116, which may be a radially raised portion extending from the first connector 110. The ring 116 may be disposed between the inlet 112 and the outlet 114. As illustrated, the ring 116 may be disposed toward the outlet 114. Optionally, the ring 116 may include a groove or recess 118 disposed therein. In the depicted example, the plurality of first retention fingers 152 and / or the protruding feature 153 may abut and engage the ring 116 to prevent axial movement of the first connector 110 relative to the coupler body 150. During insertion, after the ring 116 moves past the plurality of first retention fingers 152 and / or the protruding feature 153, the plurality of first retention fingers 152 may move radially inward and abut against the axial surface of the ring 116, biasing it axially, thereby retaining the first connector 110. In some embodiments, the protruding feature 153 of each of the plurality of first retention fingers 152 can abut and engage the ring 116. Optionally, the protruding feature 153 can have a generally square or axially facing surface that rests against the ring 116 to inhibit radial expansion of the plurality of first retention fingers 152 in response to an axial (withdrawal) force exerted against the first connector 110.

[0039] FIG. 8 is a perspective view of the coupler assembly 100 of FIG. 1 with the coupler partially cut away, according to some embodiments of the present disclosure. With continuing reference to FIGS. 1 through 7 , and referring to FIG. 8 , in the depicted example, the second connector 130 can be inserted into the cavity 155 of the coupler body 150 to engage with the coupler body 150 and the first connector 110, preventing or resisting undesired disengagement of the first connector 110. As illustrated, the inlet 132 of the second connector 130 can be guided through the second end of the coupler body 150 to a desired axial position relative to the coupler body 150. For example, the second connector 130 can be axially positioned within the coupler body 150 to allow the inlet 132 to engage or mate with the outlet 114 of the first connector 110. In some embodiments, a feature within the coupler body 150 can position the second connector 130 within the cavity of the coupler body 150. When the second connector 130 is inserted into the coupler body 150, a feature of the coupler body 150 can hold the second connector 130 in the inserted position. In some embodiments, the coupler body 150 can hold the second connector 130 axially while allowing the second connector 130 to rotate relative to the coupler body 150 and the first connector 110. Optionally, the coupler body 150 can hold the second connector 130 rotatably relative to the coupler body 150.

[0040] In some embodiments, the coupler body 150 may include a plurality of second retention fingers 154 to engage or retain the second connector 130 in an inserted or coupled axial position. The plurality of second retention fingers 154 may be radially movable to allow the second connector 130 to be inserted into the coupler body 150. For example, the plurality of second retention fingers 154 may move into and out of a cavity defined by the coupler body 150. As illustrated, the plurality of second retention fingers 154 may be hinged to the coupler body 150. In some embodiments, the plurality of second retention fingers 154 may be integrally formed with the coupler body 150. Slots or windows 158 may be cut into the material of the coupler body 150 to form the plurality of second retention fingers 154. The plurality of second retention fingers 154 may be circumferentially spaced about the coupler body 150. As depicted, the plurality of second retention fingers 154 may be arranged in groups or sets around the coupler body 150. In some embodiments, the plurality of second retention fingers 154 may be disposed at an end of the coupler body 150 that receives the second connector 130.

[0041] As illustrated, the plurality of second retention fingers 154 may be biased radially inward to engage or retain the second connector 130 within the coupler body 150. The plurality of second retention fingers 154 may exert a radially inward spring force on the second connector 130 to retain the second connector 130 within the coupler body 150. As can be appreciated, the spring force of the plurality of second retention fingers 154 may correspond to the retention force exerted on the second connector 130. The plurality of second retention fingers 154 may resiliently deform to abut and engage the second connector 130.

[0042] In some embodiments, the plurality of second retention fingers 154 may each include a protrusion or protruding feature 156 for engaging a feature on the second connector 130. The protruding feature 156 may extend radially inward to contact the second connector 130. For example, the plurality of second retention fingers 154 and / or the protruding feature 156 may abut and engage the shoulder 136 of the second connector 130.

[0043] Optionally, the second connector 130 may include a shoulder 136, which may be a radially raised portion extending from the second connector 130. The shoulder 136 may be located between the inlet 132 and the outlet 134. As illustrated, the shoulder 136 may be located toward the outlet 134.

[0044] In the depicted example, the plurality of second retention fingers 154 and / or protruding feature 156 can abut and engage the shoulder 136 to prevent and / or limit axial movement of the second connector 130 relative to the coupler body 150. During insertion, after the shoulder 136 moves past the plurality of second retention fingers 154 and / or protruding feature 156, the plurality of second retention fingers 154 may move radially inward and abut and bias against the axial surface of the shoulder 136, thereby retaining the second connector 130. In some embodiments, the protruding feature 156 of each of the plurality of second retention fingers 154 can abut and engage the shoulder 136.

[0045] Optionally, the ejection feature 156 can have a generally sloped surface that abuts and biases against the shoulder 136, allowing radial expansion of the plurality of second retention fingers 154 in response to an axial (withdrawal) force exerted against the second connector 130. In some embodiments, the coupler body 150 can be configured to allow the second connector 130 to be removed in response to a selected or predetermined withdrawal force. The second connector 130 may be removed from the coupler body 150 with a withdrawal force of 1 pound, 2 pounds, 4 pounds, 5 pounds, 10 pounds, etc. As can be appreciated, the withdrawal force can be selected to prevent inadvertent release while preventing damage to the tubing or injury to the patient.

[0046] Optionally, coupler body 150 can be configured to allow first connector 110 to remain retained when second connector 130 is removed. In other words, coupler body 150 can be configured to allow second connector 130 to be released with a smaller withdrawal force than first connector 110. After removal, second connector 130 can be reinserted into coupler body 150 to reconnect second connector 130 with first connector 110.

[0047] FIG. 9 is a perspective view of an extension set including a connector assembly according to some embodiments of the present disclosure. According to various embodiments of the present disclosure, the extension set 200 may include tubing 292 configured to couple to a source of medical fluid (e.g., IV fluid) (not shown). As depicted, the extension set 200 may further include a detachable connector assembly for selectively delivering medical fluid to the catheter assembly 291 via the mating connector 202 (e.g., a needleless connector). The extension set 200 may further include a mating luer 203 (e.g., a male luer connector) for coupling the connector assembly 201 to the tubing 292. As described in further detail below with respect to at least FIG. 10A , a flow path 238 may be defined from the lumen of the tubing 292 through the mating luer, the connector assembly, and the lumen of the needleless connector. The medical fluid may thus be delivered to the catheter 290 of the catheter assembly 291 via the flow path 238.

[0048] FIG. 10A illustrates a connector assembly 201 coupled with a mating needleless connector 202, according to some embodiments of the present disclosure. FIG. 10B illustrates a cross-sectional operational view of the connector assembly 201 with the mating needleless connector 202 when subjected to a proximally directed force F below a predetermined threshold, according to some embodiments of the present disclosure. FIG. 10C illustrates a cross-sectional operational view of the connector assembly 201 with the mating needleless connector 202 with the distal connector 212 pivoting open and sealing the flow channel 238, according to some embodiments of the present disclosure, due to a proximally directed force F above a predetermined threshold. As illustrated in FIGS. 10A-10C, the connector assembly 201 may include a proximal connector 214, a distal connector 212, and a plurality of wings 210 extending from the proximal connector 214 to the distal connector 212.

[0049] As depicted, the proximal connector 214 may define the inlet port 206 and may have an inner surface 219 that defines a cavity 216 of the proximal connector 214 and an outer surface 215 that includes at least one notch 282 recessed therein. A spring member 218 may be mounted within the cavity 216 of the proximal connector 214. In some examples, the outer surface 215 of the proximal connector 214 may include a first straight portion 280 that has at least one notch 282 recessed therein, a ramp portion 284 extending distally and radially inward from the first straight portion, and a second straight portion 286 that extends distally from the ramp portion 284.

[0050] As further depicted, distal connector 212 may have first arm 211 and second arm 213 pivotally coupled to one another and slidably coupled to proximal connector 214. For example, in some embodiments, first arm 211 and second arm 213 may each include a hinge portion (not shown) having a coupling hole. In some embodiments, a pivot pin (not shown) may be inserted through the coupling hole to couple the hinge portion of the first arm to the hinge portion of the second arm.

[0051] In some embodiments, the outer surface of each of the first arm 211 and the second arm 213 of the distal connector 212 may have a slot 250 at least partially recessed therein. The slot 250 may have a straight surface 251 extending proximally from a distal end 255 of the slot 250 and an angled surface 254 extending from the straight surface 251 to a proximal end 253 of the slot 250.

[0052] The distal connector 212 may further include an outer surface 217 and an inner surface 221 defining a cavity 243 that terminates within an open end 225 of the distal connector 212. In some embodiments, the inner surface 221 of the distal connector 212 may have at least one detent 209 and at least one slot 230 extending radially inward from the inner surface 221. As depicted, the distal connector may further include a luer portion 227 extending within the cavity 243 and through the open end 225. In some embodiments, the flow channel 238 may extend from the inlet port 206 through the luer portion 227 to an outlet port 242 of the luer portion 227. A post 220 may be disposed within the luer portion 227, extending longitudinally within the flow channel 228 from the proximal end of the spring member 218 toward the outlet port 242 of the luer portion 227. In some embodiments, post 220 may define a lumen 228 having an open end 244, an opposing closed end 246, and a passageway 248 through a sidewall between open end 244 and closed end 246. In some embodiments, post 220 may include a seal 226 on an outer surface of the closed end to prevent fluid flow through exit port 242 of luer portion 227. As depicted, post 220 may have a plurality of arms 222 extending from post 220 along the outside of luer portion 227 toward exit port 242. Each of the plurality of arms 222 may include a protrusion 224 extending radially outward from an outer surface of each of the plurality of arms 222. As depicted, when the mating connector 202 is coupled to the distal connector 212, each protrusion 224 may abut a corresponding one of the at least one stop 230 to prevent unintended expansion of the spring 218 and distal movement of the post 220.

[0053] In some embodiments, the plurality of wings 210 may extend from an outer surface 215 of the proximal connector 214 to an outer surface 217 of the distal connector 212. As described in further detail below with respect to the operation of the connector assembly 201, the distal connector 212 may be slidably coupled to the proximal connector 214 via the plurality of wings 210. In some embodiments, each of the plurality of wings 210 may have a proximal end 260 and a distal end 262. Each of the wings 210 may have an inner surface 264 including a first straight portion 266 extending proximally from the distal end 262, a ramp portion 252 extending proximally and radially outward from the first straight portion 266, and a second straight portion 270 extending proximally from the ramp portion 252. In some embodiments, the ramp portion 252 may be parallel to the inclined surface 254 of the slot 250 and the first straight portion 266 may be parallel to the straight surface 251 of the slot 250 .

[0054] According to various embodiments of the present disclosure, the ramp portions 284 of the proximal connector 214 may be parallel to the ramp surfaces 250 of the slot 250 and the ramp portions 252 of each vane 210 such that when a force F exceeding a predetermined threshold is applied to the proximal connector 214 and at least one detent 209 disengages from at least one notch 282, the distal connector 212 is translated distally relative to the proximal connector 214, and the ramp surfaces 254 of the slot 250 press against and against the ramp portions 252 of the vanes 210, causing the first and second arms 211 and 213 to pivot radially outward (as illustrated in FIG. 10C ) and widening the open ends 225 of the distal connector 212, thereby releasing the interconnectors 202 (as illustrated in FIG. 10D ).

[0055] 10D illustrates a cross-sectional operational view of the connector assembly 201 separated from the mating needleless connector 202, according to some embodiments of the present disclosure. With reference to FIGS. 10B through 10D, the operation of the connector assembly is generally described. In operation, the connector assembly 201 may be generally coupled at its distal end to a mating or interconnector 202 and coupled at its proximal end to a mating luer connector 203. In some embodiments, the mating or interconnector 202 may be a needleless connector, and the mating luer connector 203 may be a male luer connector. For example, in some embodiments, the mating connector 202 may be inserted into and coupled to the open end 225 of the distal connector 212, and the mating luer connector 203 may be inserted into and coupled to the inlet port 206 of the proximal connector 214. In some embodiments, the mating connector 202 may include threads 205 that mate with complementary threads 234 on the open end 225 of the distal connector 212. When the distal connector 212 is coupled to the mating connector 202, at least one detent 209 engages at least one notch 282 to prevent the mating connector 202 from disconnecting from the distal connector 212 when a force below a predetermined proximal threshold (pull-out) force is applied to the proximal connector 214.

[0056] 10B depicts the coupled configuration of mating connector 202 and distal connector 212 of connector assembly 201 when a force F below a predetermined proximal threshold (pull-out) force is applied to proximal connector 214. For example, connector assembly 201 may be subjected to proximally directed pull-out forces as a result of a patient turning in bed, a patient catching tubing or lines on a bed rail, a patient being moved to a different bed, a pediatric patient fiddling, and / or a confused adult patient tugging on their line. According to various embodiments of the present disclosure, when subjected to a lower withdrawal force, e.g., a force F below a predetermined proximal threshold (withdrawal) force, connector assembly 201 may be configured to retain mating connector 202 within distal connector 212 such that flow path 238 remains open and medical fluid, e.g., IV fluid, may be administered from fluid line 292 (which may be fluidly connected to a fluid container, e.g., an IV bag (not shown)) into catheter assembly 291 (illustrated in FIG. 9 ). Specifically, as illustrated in FIG. 10B , when distal connector 212 is coupled to mating connector 202, closed end 246 of post 220 (with attached seal 226) may be moved away from outlet port 242 of luer portion 227, allowing flow through flow path 238 via luer portion 227.

[0057] As depicted, in a mating configuration between the mating connector 202 and the distal connector 212, the luer portion 227 may extend through the top surface 207 and into the mating luer of the mating connector 202, displacing the flexible valve 204 of the mating connector 202. Thus, when the mating connector 202 is coupled to the distal connector 212, the mating connector 202 may exert a force to urge the plurality of arms 222 proximally, which may compress the spring member 218 and displace the closed end 246 of the post 220 away from the exit port 242 of the luer portion 227. For example, as illustrated in FIG. 10B , the plurality of arms 222 and the post 220 may be urged away from the exit port 242 of the luer portion 227 by the top surface 207. In the open position, the closed end 246 of the post 220 is moved away from the outlet port 242 of the luer portion 227, thereby allowing medical fluid to flow through the passageway 248 between the outlet port 242 of the luer portion 227 and the inner end 228 of the post 220. As previously discussed above, when the mating connector 202 is coupled to the distal connector 212, the protrusion 224 of each arm 222 may abut a corresponding one of the at least one stop 230 to prevent unintended expansion of the spring 218 and distal movement of the post 220.

[0058] 10C depicts a decoupled configuration of the mating connector 202 and distal connector 212 of the connector assembly 201 when a force F exceeding a predetermined proximal threshold (withdrawal) force is applied to the proximal connector 214. According to various embodiments of the present disclosure, when subjected to a higher withdrawal force, e.g., a force F exceeding the predetermined proximal threshold (withdrawal) force, the connector assembly 201 may be configured to release or otherwise decouple the mating connector 202 from within the distal connector 212, at which point the flow path 238 closes and medical fluid, e.g., IV fluid, may be interrupted from entering the fluid line 292 (which may be fluidly connected to a fluid container, e.g., an IV bag (not shown)). In some embodiments, the predetermined proximal threshold (withdrawal) force may be approximately 2.267 kg (5 pounds (lbs)). For example, if a patient with catheter 290 inserted beneath their skin walks away from the infusion pump, or accidentally pulls on infusion line 292 with a force exceeding 5 lbs, connector assembly 201 may automatically release or disconnect from mating connector 202, as described in more detail below, effectively closing flow path 238 connecting the patient to the infusion fluid source. The various embodiments of connector assembly 201 described herein are advantageous over conventional couplers and associated infusion systems in which a pull-out force exceeding a predetermined threshold can actually cause the catheter to dislodge or disconnect, in that dislodgement or other disconnection from mating connector 202 prevents excessive sounding of alarms intended to alert clinicians to catheter dislodgement and the potential resulting bleeding, medication leakage, and disconnection.

[0059] 10C , when a force applied to the proximal connector 214 exceeds a predetermined threshold, the at least one detent 209 may disengage from the at least one notch 282, as described in further detail below, thereby allowing the distal connector 212 to translate distally relative to the proximal connector 214 and pivot the first arm 211 and the second arm 213 radially outward to decouple the mating connector 202 from the distal connector 212. For example, during operation, when a proximal withdrawal force applied to the proximal connector exceeds a predetermined threshold, the withdrawal force causes the at least one detent 209 to disengage from or otherwise move away from the at least one notch 282. The disengagement of the at least one detent 209 from the at least one notch 282 causes the compressed spring 218 to expand, correspondingly moving the post 220 distally. As the post 220 moves distally, the protrusions 224 on each of the arms 222 of the post 220 exert a distal force against the corresponding stop 230 against which they abut, thereby moving or translating the distal connector 212 distally. Specifically, as illustrated in FIG. 10C , as the spring member expands, the first linear portion 266 of each of the wings 210 slides along the linear surface 251 of the slot 250, allowing the distal connector 212 to translate distally relative to the proximal connector 214. As the distal connector 212 continues to translate distally, each of the wings 210 continues to slide along the linear surface 251 of each slot 250 to the point where the angled surface 254 of each slot 250 contacts and abuts the ramp portion 252 of each wings. As the spring member 218 continues to expand, the angled surface 254 of each slot 250 may abut and press against the ramp portion 252 of the vane 210, causing the first arm 211 and the second arm 213 to pivot radially outward and spread the open end 225 of the distal connector 212. As the spring continues to expand distally, the spring member 218 may continue to exert a force against the post 220, which moves or otherwise biases the closed end 246 of the post 220 toward the exit port 242 of the luer portion 227 to seal the exit port 242.

[0060] 10D illustrates a cross-sectional operational view of the connector assembly 201 decoupled from the mating needleless connector 202, according to some embodiments of the present disclosure. As depicted, the first arm 211 and the second arm 213 continue to pivot radially outward, so that the mating connector 202 may then be released and fully decoupled from the distal connector 212. In this state, the outlet port 242 of the luer portion 227 is sealed by the seal 226 at the closed end 246 of the post 220, thereby closing the flow path 238 and preventing medical fluid, such as IV fluid, from exiting or otherwise spilling out of the flow path 238 via the outlet port 242 of the luer portion 227. Thus, the first arm 211 and the second arm 213 are advantageously designed to release the mating needleless connector 202 when a pulling force exceeding a threshold pulling force is applied to the tubing 292 and the proximal connector 214. Thus, both the connector assembly 201 (e.g., but not limited to, a Texium valve) and the mating connector 202 (e.g., but not limited to, a Smartsite valve) may automatically shut off when pulled apart, thereby preventing leakage or spillage of medical fluids in the event of accidental disconnection due to higher withdrawal forces above a predetermined threshold force. The above-listed configurations are advantageous over currently existing catheter removal devices or couplers, which are generally adhesive-based and may only be able to prevent catheter dislodgement at lower withdrawal forces, or may not. Such currently existing catheter removal devices or couplers are unable to prevent catheter dislodgement at higher withdrawal forces, but instead may release in response to higher withdrawal forces (e.g., greater than 5 lbs) experienced during a patient turning over in bed, a patient catching the tubing or line on a bed rail, moving a patient to a different bed, pediatric patient tampering, and / or a confused adult patient tugging on their line.

[0061] 10E illustrates a cross-sectional operational view of the connector assembly 201 with the first arm 211 and the second arm 213 of the distal connector 212 returned to a non-pivoted state, according to some embodiments of the present disclosure. According to various embodiments of the present disclosure, the first arm 211 and the second arm 213 of the distal connector 212 may be returned from the pivoted state illustrated in FIG. 10D to the non-pivoted state illustrated in FIG. 10E by pinching together or otherwise applying oppositely directed forces to the first arm 211 and the second arm 213, as illustrated by arrow C, to pivot the first arm 211 and the second arm 213 radially inward to their original state before pivoting outward.

[0062] In some embodiments, the connector assembly 201 may also be disconnected from the mating luer connector 203. The mating luer connector 203 as well as the luer portion of the mating connector 202 may then be wiped clean. In some embodiments, the connector assembly 201 may be discarded and replaced with a new, sterilized connector assembly 201 without damaging or otherwise contaminating the fluid path. The connector assembly 201 may then be coupled to the mating luer connector 203. The mating connector 203 (e.g., a needleless connector) may then be wiped clean or otherwise disinfected.

[0063] FIG. 10F illustrates a cross-sectional operational view of the connector assembly 201 with the mating connector 202 being advanced toward and initially contacted with the connector assembly 201, according to some embodiments of the present disclosure. FIG. 10G illustrates a cross-sectional operational view of the connector assembly 201 with the mating connector 202 partially inserted into the distal connector 212, according to some embodiments of the present disclosure. FIG. 10H illustrates a cross-sectional operational view of the connector assembly 201 with the mating connector 202 inserted into the distal connector 212 and moving the post 220 to open the flow passage 238, according to some embodiments of the present disclosure. In some embodiments, after sterilization of the mating connector 202, the mating connector 202 may then be coupled or connected to the sterile connector assembly 201. As depicted in FIGS. 10F-10G, the mating connector 202 may be advanced toward the luer portion of the distal connector 212. As the mating connector 202 is advanced toward the luer portion 227 of the distal connector 212, the luer portion 227 may advance into the interior of the mating connector 202 and compress the valve member 204 of the mating connector 202. As the luer portion advances further into the interior of the mating connector 202, the top surface 207 of the mating connector 202 may exert a force to urge the plurality of arms 222 proximally, which in turn may compress the spring member 218 and move the closed end 246 of the post 220 away from the exit port 242 of the luer portion 227, as illustrated in FIG. 10H. For example, as illustrated in FIG. 10B, the plurality of arms 222 and the post 220 may be urged away from the exit port 242 of the luer portion 227 by the top surface 207. In the open position, the closed end 246 of the post 220 is moved away from the exit port 242 of the luer portion 227, thereby opening the flow path 238 and allowing medical fluid to flow through the lumen 228, the passageway 248 of the post 220, and through the exit port 242 of the luer portion 227 into the mating connector 202. As previously described above, when the mating connector 202 is coupled to the distal connector 212, the protrusion 224 of each arm 222 may abut a corresponding one of the at least one stop 230 to prevent unintended expansion of the spring 218 and distal movement of the post 220.

[0064] According to various embodiments of the present disclosure, when subjected to a lower withdrawal force, e.g., a force F below a predetermined proximal threshold (withdrawal) force, connector assembly 201 may be configured to retain mating connector 202 within distal connector 212 such that flow path 238 remains open and medical fluid, e.g., IV fluid, may be administered from fluid line 292 (which may be fluidly connected to a fluid container, e.g., an IV bag (not shown)) into catheter assembly 291 (illustrated in FIG. 9 ). Specifically, as illustrated in FIG. 10B , when distal connector 212 is coupled to mating connector 202, closed end 246 of post 220 (with attached seal 226) may be moved away from outlet port 242 of luer portion 227, allowing flow through flow path 238 via luer portion 227.

[0065] As depicted, in a coupled configuration of the mating connector 202 and distal connector 212, the luer portion 227 may extend through the top surface 207 and into the mating luer of the mating connector 202, thereby displacing the flexible valve 204 of the mating connector 202. Thus, when the mating connector 202 is coupled to the distal connector 212, the mating connector 202 may exert a force to urge the distal end 223 of each of the plurality of arms 222 proximally, which may in turn compress the spring member 218 and move the closed end 246 of the post 220 away from the exit port 242 of the luer portion 227. For example, as illustrated in FIG. 10H , the plurality of arms 222 and the post 220 may be urged away from the exit port 242 of the luer portion 227 by the top surface 207. In the open position, the closed end 246 of the post 220 is moved away from the exit port 242 of the luer portion 227, thereby opening the flow path 238 and allowing medical fluid to flow through the lumen 228, the passageway 248 of the post 220, and through the exit port 242 of the luer portion 227 into the mating connector 202. Thus, infusion of medical fluid may resume. As previously discussed above, when the mating connector 202 is coupled to the distal connector 212, the protrusion 224 of each arm 222 may abut a corresponding one of the at least one stop 230 to prevent unintended expansion of the spring 218 and distal movement of the post 220.

[0066] The subject technology is exemplified according to various aspects, for example, as described below. Various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and are not intended to limit the subject technology. Note that any of the dependent clauses may be combined in any combination and placed within a respective independent clause, e.g., clause 1, clause 11, clause 17, clause 23, clause 26, or clause 29. Other clauses may be presented in a similar manner.

[0067] Clause 1. A coupler comprising: a coupler body including a first end, a second end, an outer surface, an inner surface defining a cavity, and a wall defined between the inner surface and the outer surface, the cavity being configured to receive a first connector and a second connector; a plurality of first retention fingers disposed adjacent the first end and extending radially inward into the cavity, the plurality of first retention fingers being biased radially inward toward the cavity and configured to abut and engage with a collar of the first connector to prevent axial movement of the first connector relative to the coupler; and a mounting hole defined between a free end of each first retention finger and the wall, the mounting hole being configured to receive a pivot shaft of a collar of the first connector to pivotally couple the first connector relative to a central axis of the coupler body.

[0068] Clause 2. The coupler of clause 1, wherein the coupler body further comprises a notch extending longitudinally from the first end and a window extending through the wall and positioned on the coupler body on an opposite side of the notch.

[0069] Clause 3. A coupler according to Clause 2, wherein the coupler body has a central longitudinal axis, and the notch and window are formed to cooperate so that, in a coupled configuration of the coupler and the first connector, the first connector is pivotable relative to the coupler body between a first position in which the first connector extends along the central longitudinal axis of the coupler body and a second position in which the first connector extends through the wall via the notch and window in a direction transverse to the central longitudinal axis of the coupler body.

[0070] Clause 4. The coupler of clause 2, wherein the collar is integrally formed with the first connector.

[0071] Clause 5. The coupler of clause 2, wherein the collar is detachably coupled to the first connector.

[0072] Clause 6. The coupler of clause 5, wherein the collar includes a longitudinally extending slot to allow the collar to be sleeved and mated to the first connector.

[0073] Clause 7. The coupler of clause 1, wherein the plurality of first retention fingers are spaced from the first end.

[0074] Clause 8. The coupler of clause 1, wherein the plurality of first retention fingers are circumferentially spaced apart.

[0075] Clause 9. The coupler of clause 1, wherein the plurality of first retention fingers are configured to allow rotational movement of the first connector relative to the coupler.

[0076] 10. The coupler of claim 1, wherein each of the plurality of first retention fingers includes a projection projecting radially inward.

[0077] Clause 11. The coupler of clause 1, wherein the coupler body further comprises a tapered portion on an inner surface for radially aligning the first connector within the cavity.

[0078] Clause 12. The coupler of clause 1, further comprising a plurality of second retention fingers disposed at the second end and extending radially inward into the cavity, the plurality of second retention fingers being configured to be radially biased inward toward the cavity, to abut and engage a shoulder of the second connector with a retention force, and to release the second connector by radially expanding in response to a withdrawal force exerted on the second connector that exceeds the retention force.

[0079] Clause 13. The coupler of clause 12, wherein each of the plurality of second retention fingers comprises an inclined projection extending radially inward.

[0080] Clause 14. A coupler assembly comprising: a first connector, the first connector body having a first inlet configured to be coupled to a first portion of tubing and a first outlet in fluid communication with the first inlet; and a collar sleeved over the first connector body between the first inlet and the first outlet, the collar having a body including a pivot shaft extending radially outward from the collar body opposite the collar body; and a coupler, the coupler having a first end, a second end, an inner surface defining a cavity, an outer surface, and a wall defined between the inner and outer surfaces. a coupler including a coupler body; a plurality of first retention fingers disposed adjacent a first end and extending radially inward into a cavity, the plurality of first retention fingers being biased radially inward toward the cavity and configured to abut and engage a collar to prevent axial movement of the first connector relative to the coupler; and a mounting hole defined between a free end of each first retention finger and a wall, the mounting hole being configured to receive a pivot shaft of the collar to pivotally couple the first connector to the coupler body.

[0081] Clause 15. The coupler assembly of clause 14, wherein the coupler body further comprises a notch extending longitudinally from the first end and a window extending through the wall and positioned on the coupler body on an opposite side of the notch, the notch and the window being formed to cooperate to allow the first connector to extend through the wall to an exterior of the coupler through the notch and the window when pivoted relative to the coupler body.

[0082] Clause 16. The coupler assembly of clause 15, wherein the coupler body has a central longitudinal axis, and wherein, in a coupled configuration of the coupler and the first connector, the first connector is pivotable and rotatable relative to the coupler body between a first position in which the first connector extends along the central longitudinal axis of the coupler body and a second position in which the first connector extends transverse to the central longitudinal axis of the coupler body.

[0083] Clause 17. The coupler assembly of clause 14, wherein the collar is removably coupled to the first connector.

[0084] Clause 18. The coupler assembly of clause 17, wherein the collar includes a longitudinally extending slot to allow the collar to be sleeved and mated to the first connector.

[0085] Clause 19. The coupler assembly of clause 14, further comprising a second connector comprising a second connector body having a second inlet configured to be releasably coupled to the first outlet of the first connector, and a second outlet coupled to the second portion of tubing and in fluid communication with the second inlet, and a shoulder disposed between the second inlet and the second outlet, the shoulder extending radially from the second connector body.

[0086] Clause 20. The coupler assembly of clause 19, wherein the first connector and the second connector are at least partially disposed within the cavity, and the plurality of first retention fingers are radially biased inward and abut against and engage a collar of the first connector to prevent axial movement of the first connector relative to the second connector.

[0087] Clause 21. The coupler assembly of clause 20, wherein the coupler body further comprises a plurality of second retention fingers disposed at the second end and extending radially inward into the cavity, the plurality of second retention fingers being radially biased to abut and engage a shoulder of the second connector with a retention force, and the plurality of second retention fingers being configured to release the second connector by radially expanding in response to a withdrawal force exerted on the second connector that exceeds the retention force.

[0088] Clause 22. A connector assembly comprising: a proximal connector defining an inlet port and having an inner surface defining a cavity of the proximal connector and an outer surface including at least one notch recessed therein; a distal connector having first and second arms pivotally coupled to one another and slidably coupled to the proximal connector, the outer surface, and an inner surface defining a cavity terminating within an open end of the distal connector, the inner surface including at least one detent and at least one stop extending radially inward from the inner surface, and a luer portion extending through the open end into the cavity, wherein a flow path extends from the inlet port through the luer portion to an outlet port of the luer portion; and a distal connector having a luer portion extending from the outer surface of the proximal connector to the outer surface of the distal connector. a plurality of wings extending from the distal connector, the distal connector being slidably coupled to the proximal connector via the plurality of wings; when the distal connector is coupled to the mating connector, the at least one detent engages with the at least one notch to prevent the mating connector from being decoupled from the distal connector when a force applied to the proximal connector is less than a predetermined proximal threshold force; and when the force applied to the proximal connector exceeds the predetermined threshold, the at least one detent disengages from the at least one notch to allow the distal connector to translate distally relative to the proximal connector and pivot the first and second arms radially outward to decouple the mating connector from the distal connector.

[0089] Clause 23. The connector assembly of clause 22, further comprising a spring member mounted within the cavity of the proximal connector and a post disposed within the luer portion and extending longitudinally into the flow path from a proximal end of the spring member toward the outlet port of the luer portion.

[0090] Clause 24. The connector assembly of clause 23, wherein when the distal connector is coupled to the mating connector, the closed end of the post is moved away from the outlet port of the luer portion to allow flow through the flow path through the luer portion.

[0091] Clause 25. The needleless connector of clause 24, further comprising a plurality of arms extending from the post and extending along an exterior of the luer portion toward the exit port.

[0092] Clause 26. The connector assembly of clause 25, wherein when the mating connector is coupled to the distal connector, the mating connector exerts a force to urge the plurality of arms proximally, compressing the spring member and moving the closed end of the post away from the exit port of the luer portion.

[0093] Clause 27. The connector assembly of clause 25, wherein each of the plurality of arms includes a projection extending radially outward from its outer surface, and when the mating connector is coupled to the distal connector, each projection abuts a corresponding one of the at least one stop to prevent unintended expansion of the spring and distal movement of the post.

[0094] Clause 28. The connector assembly of clause 25, wherein when the distal connector is disconnected from the mating connector, the closed end of the post seals the outlet port of the luer portion to prevent fluid from exiting the flow path through the outlet port of the luer portion.

[0095] Clause 29. The connector assembly of clause 28, wherein when a force applied to the proximal connector exceeds a predetermined threshold, the spring member expands and exerts a force on the post to move the closed end of the post toward the exit port of the luer portion to seal the exit port.

[0096] Clause 30. The connector assembly of clause 22, wherein the outer surface of each of the first and second arms of the distal connector has a slot at least partially recessed therein, the slot having a straight surface extending proximally from a distal end of the slot and an angled surface extending from the straight surface of the slot to the proximal end.

[0097] Clause 31. The connector assembly of clause 30, wherein each of the plurality of wings comprises a proximal end, a distal end, and an inner surface including a first straight portion extending proximally from the distal end, a ramp portion extending proximally and radially outward from the first straight portion, and a second straight portion extending proximally from the ramp portion.

[0098] Clause 32. The connector assembly of clause 31, wherein the ramp portion is parallel to the ramp surface of the slot and the first straight portion is parallel to the linear surface of the slot such that when a force exceeding a predetermined threshold is applied to the connector and the at least one detent disengages from the at least one notch, the first straight portion slides along the linear surface of the slot to allow the distal connector to translate distally relative to the proximal connector.

[0099] Clause 33. The connector assembly of clause 32, wherein the outer surface of the proximal connector comprises a first straight portion recessed with at least one notch, a ramp portion extending distally and radially inwardly from the first straight portion, and a second straight portion extending distally from the ramp portion.

[0100] Clause 34. The connector assembly of clause 33, wherein the ramp portions of the proximal connector are parallel to the ramp surfaces of the slot and the ramp portions of the vanes such that when a force exceeding a predetermined threshold is applied to the connector causing the at least one detent to disengage from the at least one notch and translate the distal connector distally relative to the proximal connector, the ramp surfaces of the slot abut and press against the ramp portions of the vanes, pivoting the first and second arms radially outward and spreading the open ends of the distal connector to release the interconnectors.

[0101] Clause 35. The connector assembly of clause 22, wherein the mating connector comprises a needleless connector.

[0102] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The 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 generic principles defined herein may be applied to other aspects.

[0103] Reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." The term "some" refers to one or more unless specifically so stated. Masculine pronouns (e.g., he) also include feminine and neuter pronouns (e.g., she and she), and vice versa. Headings and sub-headings, if any, are used merely for convenience and do not limit the invention.

[0104] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" should not necessarily be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0105] The use of phrases such as "aspects" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure relating to one aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. Disclosure relating to one embodiment may apply to all embodiments, or to one or more examples. An embodiment may provide one or more examples. A phrase such as an embodiment may refer to one or more examples, and vice versa. A phrase such as "configuration" does not imply that such an embodiment is essential to the subject technology or that such an embodiment applies to all configurations of the subject technology. Disclosure relating to one configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as a configuration may refer to one or more configurations, and vice versa.

[0106] In one aspect, unless stated otherwise, all measurements, values, ratings, locations, dimensions, sizes and other specifications set forth in this specification, including the following claims, are approximate and not exact, and in one aspect, they are intended to have a reasonable range consistent with the function to which they relate and that which is customary in the art to which they pertain.

[0107] In one aspect, the term "coupled" or the like may refer to being directly coupled. In another aspect, the term "coupled" or the like may refer to being indirectly coupled.

[0108] Terms such as "top," "bottom," "front," and "rear," when used in this disclosure, should be understood to refer to an arbitrary reference frame rather than the conventional gravity reference frame. Thus, top, bottom, front, and rear surfaces may extend upward, downward, diagonally, or horizontally in the gravity reference frame.

[0109] Various items may be arranged differently (e.g., placed in a different order or partitioned in a different manner) without departing from the scope of the subject technology. All structural and functional equivalents comparable to the elements of the various embodiments described throughout this disclosure, known or later known to those skilled in the art, are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is explicitly recited in the claims. No claim element is to 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, unless the element is recited using the phrase "step for." Furthermore, to the extent the terms "comprise," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprising" is construed when used as a transitional term in the claims.

[0110] The title, background, summary, brief description of the drawings, and abstract of the disclosure are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. They are presented with the understanding that they will not be used to limit the scope or meaning of the claims. Additionally, in the Detailed Description, the description provides illustrative examples, and it will be appreciated that various features have been grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure should not be interpreted as reflecting an intention that claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in fewer than all features of a single disclosed configuration or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.

[0111] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the claims' language and encompass all legal equivalents. Nonetheless, none of the claims are intended to, and should not be construed to, encompass subject matter that does not meet the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. In couplers, a coupler body including a first end, a second end, an outer surface, an inner surface defining a cavity, and a wall defined between the inner surface and the outer surface, the cavity being configured to receive a first connector and a second connector; a plurality of first retention fingers disposed adjacent the first end and extending radially inward into the cavity, the plurality of first retention fingers being biased radially inward toward the cavity and configured to abuttingly engage a collar of the first connector to prevent axial movement of the first connector relative to the coupler; a mounting hole defined between a free end of each first retention finger and the wall, the mounting hole configured to receive a pivot shaft of the collar of the first connector to pivotally couple the first connector relative to a central axis of the coupler body; A coupler comprising:

2. 2. The coupler of claim 1, wherein the coupler body further comprises a notch extending longitudinally from the first end and a window extending through the wall and positioned on an opposite side of the coupler body from the notch.

3. 3. The coupler of claim 2, wherein the coupler body has a central longitudinal axis, and the notch and the window are configured to cooperate such that, in a coupled configuration of the coupler and the first connector, the first connector is pivotable relative to the coupler body between a first position in which the first connector extends along the central longitudinal axis of the coupler body and a second position in which the first connector extends through the wall via the notch and the window in a direction transverse to the central longitudinal axis of the coupler body.

4. The coupler of claim 2 , wherein the collar is integrally formed with the first connector.

5. The coupler of claim 2 , wherein the collar is removably coupled to the first connector.

6. The coupler of claim 1 , wherein the plurality of first retention fingers are spaced apart from the first end.

7. The coupler of claim 1 , wherein the plurality of first retention fingers are configured to allow rotational movement of the first connector relative to the coupler.

8. The coupler of claim 1 , wherein the coupler body further comprises a tapered portion on the inner surface for radially aligning the first connector within the cavity.

9. a plurality of second retention fingers disposed at the second end and extending radially inward into the cavity, the plurality of second retention fingers being biased radially inward toward the cavity; a retaining force abutting and engaging a shoulder of the second connector; 10. The coupler of claim 1, configured to release the second connector by radially expanding in response to a withdrawal force exerted on the second connector that exceeds the retention force.

10. In the coupler assembly: a first connector, a first connector body having a first inlet configured to be coupled to a first section of tubing and a first outlet in fluid communication with the first inlet; a first connector including a collar sleeved over the first connector body between the first inlet and the first outlet, the collar having a body including a pivot shaft extending radially outward from the collar body opposite the collar body; A coupler, a coupler body including a first end, a second end, an inner surface defining a cavity, an outer surface, and a wall defined between the inner surface and the outer surface; a plurality of first retention fingers disposed adjacent the first end and extending radially inward into the cavity, the plurality of first retention fingers being biased radially inward toward the cavity and configured to abuttingly engage the collar to prevent axial movement of the first connector relative to the coupler; and a coupler including a mounting hole defined between a free end of each first retention finger and the wall, the mounting hole configured to receive the pivot shaft of the collar to pivotally couple the first connector to the coupler body; A coupler assembly comprising:

11. 11. The coupler assembly of claim 10, wherein the coupler body further comprises a notch extending longitudinally from the first end and a window extending through the wall and positioned on the coupler body opposite the notch, the notch and the window being formed to cooperate to allow the first connector to extend through the wall to an exterior of the coupler through the notch and the window when pivoted relative to the coupler body.

12. 12. The coupler assembly of claim 11, wherein the coupler body has a central longitudinal axis, and wherein, in a coupled configuration of the coupler and the first connector, the first connector is pivotable and rotatable relative to the coupler body between a first position in which the first connector extends along the central longitudinal axis of the coupler body and a second position in which the first connector extends transverse to the central longitudinal axis of the coupler body.

13. a second connector body including a second inlet configured to be releasably coupled to the first outlet of the first connector, and a second outlet coupled to a second portion of tubing and configured to be in fluid communication with the second inlet; a second connector comprising a shoulder disposed between the second inlet and the second outlet; The coupler assembly of claim 10 , wherein the shoulder extends radially from the second connector body.

14. 14. The coupler assembly of claim 13, wherein the first connector and the second connector are at least partially disposed within the cavity, and the plurality of first retention fingers are biased radially inward to abut and engage the collar of the first connector, thereby preventing axial movement of the first connector relative to the second connector.

15. In the connector assembly, a proximal connector defining an entry port and having an inner surface defining a cavity of the proximal connector and an outer surface including at least one notch recessed therein; a distal connector, first and second arms pivotally coupled to one another and slidably coupled to the proximal connector; an outer surface and an inner surface defining a cavity terminating in the open end of the distal connector, the inner surface including at least one detent and at least one stop extending radially inward from the inner surface; a distal connector including a luer portion extending through the open end into the cavity, a flow path extending from the inlet port through the luer portion to an outlet port of the luer portion; a plurality of wings extending from the outer surface of the proximal connector to the outer surface of the distal connector, the distal connector being slidably coupled to the proximal connector via the plurality of wings; when the distal connector is coupled to the mating connector, the at least one detent engages the at least one notch to prevent the mating connector from being disconnected from the distal connector at or below a predetermined proximal threshold force applied to the proximal connector; when the force applied to the proximal connector exceeds the predetermined threshold, the at least one detent disengages from the at least one notch, thereby allowing the distal connector to translate distally relative to the proximal connector and pivot the first and second arms radially outward to disconnect the mating connector from the distal connector.

16. a spring member mounted within the cavity of the proximal connector; 16. The connector assembly of claim 15, further comprising a post disposed within the luer portion and extending longitudinally into the flow passage from a proximal end of the spring member toward the exit port of the luer portion.

17. 17. The connector assembly of claim 16, wherein when the distal connector is coupled to the mating connector, the closed end of the post is moved away from the outlet port of the luer portion to allow flow through the flow path via the luer portion.

18. 16. The connector assembly of claim 15, wherein an outer surface of each of the first and second arms of the distal connector includes a slot at least partially recessed therein, the slot including a straight surface extending proximally from a distal end of the slot and an angled surface extending from the straight surface to a proximal end of the slot.

19. 20. The connector assembly of claim 18, wherein each of the plurality of wings comprises a proximal end, a distal end, and an inner surface including a first straight portion extending proximally from the distal end, a ramp portion extending proximally and radially outward from the first straight portion, and a second straight portion extending proximally from the ramp portion.

20. The connector assembly of claim 15 , wherein the mating connector comprises a needleless connector.

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