Needleless Connector

Abstract

A needleless connector is described herein. The needleless connector includes a housing and a flexible valve element. The housing includes a cavity, a proximal fluid port in fluid communication with the cavity, and a distal fluid port in fluid communication with the cavity. The flexible valve element is disposed within the cavity. The flexible valve element can selectively allow flow between the proximal and distal fluid ports.

Description

[Technical Field]

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

[0002] Medical procedures often involve the infusion of medical fluids (e.g., saline or liquid medications) into patients using an IV catheter connected to a fluid source, such as an IV bag, via an arrangement of flexible tubing and fittings commonly referred to as an "intravenous (IV) set." Certain needleless connectors may be used in IV sets and may have self-sealing ports that prevent fluid leakage when a mating medical device is removed from such a needleless connector. Additionally, needleless connectors may include mechanical valves, such as collapsible valves having flexible material, to provide the self-sealing ports and control fluid flow within the IV set.

[0003] In some applications, needleless connectors can be difficult to connect, prime, clean, and / or disconnect without forming droplets. Summary of the Invention

[0004] The disclosed subject matter relates to a connector having an improved valve element and housing. In certain embodiments, a needleless connector is disclosed having a housing having a cavity, a proximal fluid port in fluid communication with the cavity, and a distal fluid port in fluid communication with the cavity, and a flexible valve element disposed within the cavity to selectively allow fluid flow between the proximal and distal fluid ports.

[0005] In certain embodiments, a needleless connector is disclosed having a housing having a proximal portion, a distal portion, the proximal portion and the distal portion coupled together to cooperatively define a cavity, a proximal fluid port in fluid communication with the cavity, and a distal fluid port in fluid communication with the cavity; a valve diaphragm configured to expand when a luer is inserted into the proximal fluid port and to contract (retract) when the luer is removed from the proximal fluid port; a cone coupled to the valve diaphragm and extending toward the proximal fluid port; a retention edge, at least a portion of which is captured within the housing; and a flexible valve element having a valve tail extending into the cavity that deflects to selectively allow flow between the proximal and distal fluid ports.

[0006] It is understood that various configurations of the subject technology will be readily apparent to those skilled in the art from this disclosure, and that various configurations of the subject technology have been shown and described by way of example. As will be recognized, the subject technology is capable of other different configurations, and its several details are capable of modification 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.

[0007] The accompanying drawings, which are included to provide a further understanding, and are incorporated in and constitute a part of this specification, illustrate disclosed embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. [Brief explanation of the drawings]

[0008] [Figure 1] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 2] 1A-1C are side elevational views of a flexible valve element according to various aspects of the present disclosure. [Figure 3] FIG. 1 is a front elevation view of a flexible valve element according to various aspects of the present disclosure. [Figure 4]1A-1C are partial cross-sectional views of a needleless connector with a flexible valve element in a sealed position, according to various aspects of the present disclosure. [Figure 5] 1A-1C are partial cross-sectional views of a needleless connector with a flexible valve element in a flow position according to various aspects of the present disclosure. [Figure 6] 1A-1C are partial cross-sectional views of a flexible valve element according to various aspects of the present disclosure. [Figure 7] 1A-1C are partial cross-sectional views of a flexible valve element according to various aspects of the present disclosure. [Figure 8] FIG. 1 is a perspective view of a flexible valve element according to various aspects of the present disclosure. [Figure 9] 1A-1C are cross-sectional views of flexible valve elements according to various aspects of the present disclosure. [Figure 10] FIG. 10 is a top view of a flexible valve element according to various aspects of the present disclosure. [Figure 11] 1 is a partial cross-sectional view of a needleless connector according to various aspects of the present disclosure. [Figure 12] 1 is a partial cross-sectional view of a needleless connector according to various aspects of the present disclosure. [Figure 13] 1 is a perspective cross-sectional view of a housing according to various aspects of the present disclosure. [Figure 14] FIG. 10 is a detailed cross-sectional view of a housing according to various aspects of the present disclosure. [Figure 15] 1 is an elevational cross-sectional view of a housing according to various aspects of the present disclosure. FIG. [Figure 16] FIG. 1 is a perspective view of a housing according to various aspects of the present disclosure. [Figure 17] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 18] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 19] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 20] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 21] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 22]FIG. 10 is a detailed cross-sectional view of a housing according to various aspects of the present disclosure. [Figure 23] FIG. 1 is a perspective view of a housing portion according to various aspects of the present disclosure. [Figure 24] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 25] FIG. 1 is a perspective view of a housing according to various aspects of the present disclosure. [Figure 26] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 27] FIG. 1 is a perspective view of a housing portion according to various aspects of the present disclosure. [Figure 28] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 29] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 30] FIG. 1 is a perspective view of a collar according to various aspects of the present disclosure. [Figure 31] 1A-1C are cross-sectional views of flexible valve elements according to various aspects of the present disclosure. [Figure 32] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 33] 1 is a partial cross-sectional view of a collar according to various aspects of the present disclosure. [Figure 34] 1 is a partial cross-sectional view of a housing portion according to various aspects of the present disclosure. [Figure 35] 1A-1C are cross-sectional views of flexible valve elements according to various aspects of the present disclosure. [Figure 36] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 37] 1 is a detailed cross-sectional view of a needleless connector according to various aspects of the present disclosure. [Figure 38] FIG. 1 is a perspective view of a collar according to various aspects of the present disclosure. [Figure 39] 1 is a partial cross-sectional view of a collar according to various aspects of the present disclosure. [Figure 40] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 41] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 42] 1A and 1B are cross-sectional views of needleless connectors according to various aspects of the present disclosure. [Figure 43] FIG. 10 is a detailed view of a housing portion according to various aspects of the present disclosure. [Figure 44] FIG. 10 is a detailed view of a housing portion according to various aspects of the present disclosure. [Figure 45] 1 is a detailed cross-sectional view of a needleless connector according to various aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0009] The disclosed needleless connectors incorporate various features to facilitate connecting, priming, cleaning, and / or disconnecting the connector. The features may include, but are not limited to, valve tail features, valve diaphragm features, and housing design features. By providing a needleless connector with one or more of these features, the needleless connector can provide improved connecting, priming, cleaning, and / or disconnecting operations compared to conventional needleless connectors.

[0010] The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to present limited 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 can be practiced without these specific details. In some instances, well-known structures and components are shown in block diagrams to avoid obscuring the concepts of the subject technology. Similar components are labeled with the same element numbers for ease of understanding. Reference numerals are collectively referred to by the same numeral without a suffix, but may be labeled with a suffix to represent separate instances of the common element.

[0011] While the following description is directed to the administration of medical fluids to a patient by a medical professional using the disclosed needleless connector, it should be understood that this description is merely an example of use and does not limit the scope of the claims. Various aspects of the disclosed needleless connector may be used in any application where it is desirable to allow the withdrawal of blood and other fluids from a patient while preventing the transfer of bacteria, microorganisms, and other pathogens.

[0012] The disclosed needleless connector overcomes several challenges discovered with certain conventional connectors. One challenge with certain conventional needleless self-sealing connectors is that they can be difficult to connect, potentially requiring clinicians to spend a lot of time connecting IV sets. Another challenge with certain conventional needleless self-sealing connectors is that they can require large volumes for priming and rinsing, potentially increasing the amount of fluid administered or leading to inaccurate fluid administration. Furthermore, another challenge with certain conventional needleless self-sealing connectors is that they can create large droplets upon disconnection. Additionally, another challenge with certain conventional needleless self-sealing connectors is that they can include valve elements that are neither resilient nor easy to manufacture.

[0013] Therefore, in accordance with the present disclosure, it would be advantageous to provide a needleless connector as described herein that can facilitate connection, priming, and disconnection. Additionally, it would be advantageous to provide a needleless connector as described herein that can include features that make it resilient and easily manufactured.

[0014] DETAILED DESCRIPTION OF THE INVENTION Examples of needleless connectors are now described that provide improved connection, priming, cleaning and / or disconnection operations compared to conventional needleless connectors.

[0015] FIG. 1 is a cross-sectional view of a needleless connector 100 according to various aspects of the present disclosure. In the illustrated example, the needleless connector 100 is a self-sealing port that provides IV access to a patient while also preventing fluid leakage when a mating medical device is removed from the needleless connector 100. As illustrated, fluid flow from an IV set can be introduced to a patient via the proximal fluid port 104, through the housing 102, through the distal fluid port 110, and into the patient via the patient's tubing. Additionally, in some embodiments, blood or other fluids from the patient can be withdrawn from the distal fluid port 110, through the housing 102, and into the proximal fluid port 104. As shown, the proximal fluid port 104 and the distal fluid port 110 can include any suitable fittings, including, but not limited to, luer fittings. In the illustrated example, the proximal fluid port 104 is shown as a female luer fitting, and the distal fluid port 110 is shown as a male luer fitting.

[0016] As illustrated, the housing 102 of the needleless connector 100 contains a flexible valve element 130 within a cavity 103 of the housing 102. In the illustrated example, a proximal fluid port 104 is in fluid communication with the cavity 103 of the housing 102. The proximal fluid port 104 may be threaded to facilitate connection with a mating medical device.

[0017] As illustrated, the flexible valve element 130 can selectively seal the internal cavity 103 of the housing 102 to allow or restrict flow through the proximal fluid port 104. The flexible valve element 130 can have a body 131 with a sealing portion 132 disposed toward a proximal portion 136 of the flexible valve element 130. The sealing portion 132 can further include a cutout portion 134 to facilitate flow through the flexible valve element 130 by easily deforming upon insertion of a mating medical instrument. The body 131 of the flexible valve element 130 can be formed from silicone or other elastomeric material that elastically deforms and recovers to enable selective sealing of the proximal fluid port 104. The distal fluid port 110 can be generally in fluid communication with the cavity 103. The distal fluid port 110 can be coupled to the patient's tubing.

[0018] In the illustrated example, the flexible valve element 130 forms a seal that generally prevents fluid flow through the proximal fluid port 104 and the needleless connector 100, thereby preventing leakage, when a mating medical device is not connected with the proximal fluid port 104. Thus, when the needleless connector 100 is not being accessed, the sealing portion 132 and flexible body 131 of the flexible valve element 130 generally seal the internal cavity 103, preventing fluid flow therethrough.

[0019] In operation, a mating medical device can be attached to needleless connector 100. The medical device can be used to introduce fluids or medications into a patient or to withdraw blood or other fluids from a patient via needleless connector 100. The medical device can be connected to proximal fluid port 104 via threaded connection 152.

[0020] During operation, a male fitting of a medical device may be introduced into the cavity 103 of the housing 102. Upon introduction of the male fitting into the cavity 103, the flexible valve element 130 may have sufficient resilience to deform or flex out of sealing engagement with the cavity 103 to allow fluid flow between the needleless connector 100 and the medical device 150. The flexible valve element 130 may return to its original shape upon disengagement of the male fitting.

[0021] In the illustrated example, the needleless connector 100 may be a positive displacement device. For example, when a new connection is made at the proximal fluid port 104, the volume of the internal cavity 103 decreases and the needleless connector 100 aspirates fluid from either the proximal fluid port 104 or the distal fluid port 110. Thus, when a disconnection is made at the proximal fluid port 104, the needleless connector 100 expels fluid from the cavity 103, effectively cleaning the needleless connector 100.

[0022] During operation, when fluid is introduced from the medical instrument into the patient, such as when introducing saline or medication into the patient, the fluid can flow from the proximal fluid port 104 to the distal fluid port 110 and into the patient's tubing. In the illustrated example, the flow is directed from the medical instrument toward the cavity 103. The bent or deformed flexible valve element 130 allows the flow to pass over the proximal fluid port 104, through the distal fluid port 110, and into the patient's tubing.

[0023] In some applications, when fluid is drawn from a patient, such as when blood is drawn, the fluid can flow from the distal fluid port 110 to the proximal fluid port 104 and further to the medical instrument. In the illustrated example, the fluid drawn from the patient is directed from the distal fluid port 110 through the flexible valve element 130, which is bent or deformed to allow the flow to continue to the proximal fluid port 104.

[0024] As described herein, one or more elements of the needleless connector 100 may be modified to facilitate improved connection, priming, and disconnection compared to certain conventional connectors.

[0025] FIG. 2 is a side elevational view of a flexible valve element 230 according to various aspects of the present disclosure. FIG. 3 is a front elevational view of a flexible valve element 230 according to various aspects of the present disclosure. FIG. 4 is a partial cross-sectional view of a needleless connector 200 with the flexible valve element 230 in a sealed position according to various aspects of the present disclosure. FIG. 5 is a partial cross-sectional view of a needleless connector 200 with the flexible valve element 230 in a flow position according to various aspects of the present disclosure. In some embodiments, the needleless connector 200 may include similar features as the needleless connector 100. Accordingly, certain features of the needleless connector 200 may be referred to using similar reference numerals. With reference to FIGS. 2-5, the flexible valve element 230 may include features that allow a clinician to easily make a connection with the needleless connector 200.

[0026] As described with respect to needleless connector 100, flexible valve element 230 can allow or restrict flow through needleless connector 200. During operation, flexible valve element 230 deforms to allow flow through needleless connector 200. In the illustrated example, flexible valve element 230 includes an elongated tail 235 to control the amount of force required to sufficiently deform flexible valve element 230 and allow flow through needleless connector 200.

[0027] In the illustrated example, the flexible valve element 230 includes an elongated tail 235 with a reduced spring constant to reduce the insertion force required to sufficiently deform the flexible valve element 230 and allow flow through the needleless connector 200. In some embodiments, the elongated tail 235 of the flexible valve element 230 is longer than the tail of the flexible valve element 230. Thus, in some applications, the elongated tail 235 of the flexible valve element 230 may allow for a lower spring force over a longer distance or length, allowing for easier insertion. Furthermore, the extended length and lower spring force of the elongated tail 235 may allow for more reliable and / or rapid closure of the needleless connector 200 during detachment of the mating medical device.

[0028] In some embodiments, the slenderness of elongate tail 235 may allow for a greater amount of deflection (strain) of elongate tail 235 in an unactuated state, increasing the preload of flexible valve element 230. In some embodiments, elongate tail 235 may include one or more bends 237a, 237b, 237c to allow for a larger amount of elongate tail 235 to be positioned within cavity 203 of housing 202. Additionally, in some applications, bends 237a, 237b, 237c may facilitate bending or deformation of elongate tail 235. In some applications, cavity 203 may be enlarged relative to cavity 103 to facilitate deflection of elongate tail 235 without prematurely "bottoming out" during insertion of a mating medical device.

[0029] Advantageously, the configuration of the elongated tail 235 and / or the enlarged cavity 203 may allow for reduced connection force, reduced droplet size, and / or reduced droplet splashing. For example, the elongated tail 235 may allow for more secure closure of the needleless connector 200 upon detachment of the mating medical device, reducing droplet size. However, the response time of the elongated tail 235 may be short enough to maintain contact with the mating medical device (e.g., a syringe) during rapid detachment. Advantageously, the rapid response of the elongated tail 235 may prevent an increase in fluid volume in front of the valve face, preventing droplet splashing.

[0030] 6 is a partial cross-sectional view of a flexible valve element 230 according to various aspects of the present disclosure. Referring to FIG. 6, in some applications, the proximal portion 236 of the flexible valve element 230 may have a generally conical shape to enable sealing and / or engagement with a respective housing. In some embodiments, the conical shape of the proximal portion 236 may be enlarged compared to certain conventional needleless valve elements to improve sealing performance.

[0031] FIG. 7 is a partial cross-sectional view of a flexible valve element 230 according to various aspects of the present disclosure. Referring to FIG. 7 , in some embodiments, the sealing portion or diaphragm 232 of the flexible valve element 230 can be configured to displace a small amount of fluid during connection and disconnection of the needleless connector 200. During operation, the diaphragm 232 can expand when a mating medical device is inserted and contract when the mating medical device is removed. Removal of the mating medical device can cause positive fluid displacement during disconnection. In some embodiments, the structure and / or configuration of the diaphragm can result in a smaller amount of displacement during disconnection of the needleless connector 100.

[0032] In some embodiments, diaphragm body 233 can be stretched to increase the path length of diaphragm 232 during insertion of a mating medical device. Advantageously, increasing the length of travel of diaphragm 232 by stretching diaphragm body 233 can reduce strain on diaphragm body 233 during insertion and increase the resiliency of the flexible valve element. In some applications, diaphragm 232 can have a higher resistance to tearing compared to certain conventional valve elements.

[0033] FIG. 8 is a perspective view of a flexible valve element 230 according to various embodiments of the present disclosure. FIG. 9 is a cross-sectional view of a flexible valve element 230 according to various embodiments of the present disclosure. FIG. 10 is a top view of a flexible valve element 230 according to various embodiments of the present disclosure. With reference to FIGS. 8-10, the diaphragm 232 may include additional features to reduce strain during operation. For example, the diaphragm 232 may be designed with an asymmetrical shape. As illustrated, the diaphragm 232 may be configured to be "D" shaped, which encourages the diaphragm body 233 to extend or move in a specific path to minimize stress on the diaphragm 232.

[0034] In some applications, diaphragm body 233 may be asymmetrically elongated to increase the path length of travel on one side of diaphragm 232 during insertion of a mating medical device. For example, a portion of diaphragm body 233b may define a longer path length than a shorter side of diaphragm body 233a. Advantageously, by extending the length of travel of diaphragm 232 on one side by stretching diaphragm body 233b, strain on diaphragm body 233 may be reduced during insertion, increasing the resiliency of the flexible valve element. Furthermore, by stretching diaphragm body 233b, flexible valve element 230 may be biased or otherwise configured to deform or distort in a specific, predictable manner. Furthermore, in some embodiments, the elongation of diaphragm body 233b may correspond to the rounded portion of the “D” shape of diaphragm body 232.

[0035] 11 is a partial cross-sectional view of a needleless connector 200 according to various aspects of the present disclosure. In the illustrated example, the housing 202 may hold or capture the flexible valve element 230 relative to the housing 202 to maintain sterility of the fluid pathway and maintain the position of the diaphragm 232 relative to the housing 202. In some embodiments, the housing 202 may include a tapered channel 205 for capturing and retaining the diaphragm 232 of the flexible valve element 230. Optionally, a portion of the diaphragm 232 may be deformed within the tapered channel 205, allowing the diaphragm 232 and flexible valve element 230 to be entirely captured relative to the housing 202.

[0036] 12 is a partial cross-sectional view of a needleless connector 200 according to various aspects of the present disclosure. In some embodiments, the needleless connector 300 may include similar features as the needleless connector 200. Accordingly, certain features of the needleless connector 300 may be referred to using similar reference numerals.

[0037] Similar to the needleless connector 200, the housing 302 can hold or capture the flexible valve element 330 relative to the housing 302. In the illustrated example, the housing 302 can include a channel 305 for capturing and retaining the diaphragm 332 of the flexible valve element 330. As illustrated, the channel 305 can include a wide portion 305a having a width A and a narrow portion 305b having a width B. The geometry of the channel 305 can allow the wide portion of the diaphragm 332 to be positioned within the wide portion 305a, while the narrow portion 305b prevents the diaphragm 332 from passing through the narrow portion 305b and from pulling inward during insertion of a mating medical device.

[0038] FIG. 13 is a perspective cross-sectional view of a housing 402 according to various aspects of the present disclosure. FIG. 13 is a detailed cross-sectional view of a housing 402 according to various aspects of the present disclosure. FIG. 15 is an elevation cross-sectional view of a housing 402 according to various aspects of the present disclosure. In some embodiments, the needleless connector 400 may include similar features to the needleless connector 100. Accordingly, certain features of the needleless connector 400 may be referred to using similar reference numerals. In the illustrated example, the housing 402 may define one or more flow channels 407 to facilitate cleaning of the needleless connector 400. Advantageously, the flow channels 407 formed in the housing 402 may enable efficient cleaning of the needleless connector 400. In some embodiments, the housing 402 is a two-piece housing defining a flow channel 407 between two parts of the housing 402. The flow channel 407 may be encompassed by a crush rib.

[0039] 16 is a perspective view of a housing 502 according to various aspects of the present disclosure. FIG. 17 is a cross-sectional view of a needleless connector 500 according to various aspects of the present disclosure. In some embodiments, the needleless connector 500 may include similar features as the needleless connector 100. Accordingly, certain features of the needleless connector 500 may be referred to using similar reference numerals. In some embodiments, the diaphragm 532 of the flexible valve element 520 may include a shroud 532a extending axially along the length of the housing 502. In some embodiments, a silicone wall may seal the flow channel 507 from other portions of the housing 502.

[0040] 18 is a cross-sectional view of a needleless connector 600 according to various aspects of the present disclosure. In some embodiments, the needleless connector 600 may include similar features as the needleless connector 100. Accordingly, certain features of the needleless connector 600 may be referred to using similar reference numerals. In the illustrated example, the proximal fluid port 604 and the distal fluid port 610 of the housing 620 may be offset relative to one another. As illustrated, the axis of the proximal fluid port 604 is laterally offset relative to the axis of the distal fluid port 610.

[0041] 19 is a cross-sectional view of a needleless connector 700 according to various aspects of the present disclosure. In some embodiments, the needleless connector 700 may include similar features as the needleless connector 100. Accordingly, certain features of the needleless connector 700 may be referred to using similar reference numerals. In the illustrated example, the housing 702 may be a two-piece housing that snaps or press-fits together. In some embodiments, the upper portion 702a may be connected to the lower portion 702b to define the housing. The upper portion 702a may be connected to the lower portion 702b with a snap-fit ​​joint. Optionally, certain edges of the upper portion 702a and the lower portion 702b may include press-fit joints to enable a fluid seal.

[0042] 20 is a cross-sectional view of a needleless connector 800 according to various aspects of the present disclosure. In some embodiments, the needleless connector 800 may include similar features as the needleless connector 700. Accordingly, certain features of the needleless connector 800 may be referred to using similar reference numerals. As with the needleless connector 700, the housing 802 may have a multi-piece construction. In some embodiments, the flow channel 807 may be defined by a silicone or soft plastic material. The material defining the flow channel 807 may be overmolded and / or press-fit to allow for a seal. Advantageously, the softer silicone or plastic material may absorb less energy during the ultrasonic welding process.

[0043] FIG. 21 is a cross-sectional view of needleless connector 900 according to various aspects of the present disclosure. FIG. 22 is a detailed cross-sectional view of housing 902 according to various aspects of the present disclosure. FIG. 23 is a perspective view of housing portions or bases 902c and 902d according to various aspects of the present disclosure. In some embodiments, needleless connector 900 can include similar features as needleless connector 800. Accordingly, certain features of needleless connector 900 can be referred to using similar reference numerals. Like needleless connector 800, housing 902 can have a multi-piece construction.

[0044] In some embodiments, an upper portion 902a can be connected to a lower portion 902b to define the housing 902. The upper portion 902a can be connected to the lower portion 902b with a snap-fit ​​joint, as shown in FIG. 22. As illustrated, the needleless connector 900 can include an O-ring 902d disposed between a base 902c and the rest of the housing 902 to seal the fluid path within the housing and to the distal fluid port 910. In some embodiments, the components of the housing 902 can be ultrasonically welded and / or glued. Advantageously, the structure of the needleless connector 900 can reduce assembly complexity.

[0045] Figure 24 is a cross-sectional view of a needleless connector 1000 according to various aspects of the present disclosure. Figure 25 is a perspective view of a housing 1002 according to various aspects of the present disclosure. In some embodiments, the needleless connector 1000 can include similar features as the needleless connector 100. Accordingly, certain features of the needleless connector 1000 can be referred to using similar reference numerals.

[0046] In the illustrated example, the housing 1002 may define one or more flow channels 1007 to facilitate cleaning of the needleless connector 1000. Advantageously, the flow channels 1007 formed in the housing 1002 may allow for efficient cleaning of the needleless connector 1000. In some embodiments, the housing 1002 is a two-piece housing defining the flow channels 1007 between two parts of the housing 1002. The flow channels 1007 may be encompassed by crush ribs 1007a to prevent fluid from leaking into other parts of the housing 1002 or to the exterior.

[0047] As illustrated, crush ribs 1007a may be molded into the housing 1002 and engage (via an interference fit) with the interior geometry of the cap of the housing 1002 to form a liquid-tight barrier. The housing 1002 may include two crush ribs 1007a that define the main flow channel 1007. The housing 1002 may further include crush ribs 1007a around the periphery to further prevent fluid escape.

[0048] Figure 26 is a cross-sectional view of a needleless connector 1100 according to various aspects of the present disclosure. Figure 27 is a perspective view of a housing portion 1102 according to various aspects of the present disclosure. In some embodiments, the needleless connector 1100 can include similar features as the needleless connector 100. Accordingly, certain features of the needleless connector 1100 can be referred to using similar reference numerals.

[0049] In the illustrated example, the housing 1102 can define one or more flow channels 1107 to facilitate cleaning of the needleless connector 1100. Advantageously, the flow channels 1107 can be configured to minimize priming and cleaning volumes. As illustrated, the volume of the flow channels 1107 disposed in the base 1102b can be reduced to reduce the volume of fluid during priming and / or cleaning.

[0050] 28 is a cross-sectional view of a needleless connector 1200 according to various aspects of the present disclosure. In some embodiments, the needleless connector 1200 may include similar features as the needleless connector 100. Accordingly, certain features of the needleless connector 1200 may be referred to using similar reference numerals. In the illustrated example, the housing 1202 may provide a loose fit between the outer portion 1202a of the housing and the collar 1202b of the housing 1202. Advantageously, by providing a loose fit between the housing 1202 and the collar 1202b, welding or additional processing steps may be reduced.

[0051] FIG. 29 is a cross-sectional view of a needleless connector 1300 according to various aspects of the present disclosure. FIG. 30 is a perspective view of a collar 1302b according to various aspects of the present disclosure. FIG. 31 is a cross-sectional view of a flexible valve element 1330 according to various aspects of the present disclosure. In some embodiments, the needleless connector 1300 may include similar features as the needleless connector 100. Accordingly, certain features of the needleless connector 1300 may be referred to using similar reference numerals. In the illustrated example, the housing 1302 may provide a gap between the outer portion 1302a of the housing and the collar 1302b of the housing 1302. In some embodiments, an elongated septum 1332a extending from the diaphragm 1332 of the flexible valve element 1330 may extend into the gap defined between the housing 1302a and the collar 1302b. As illustrated, the diameter of 1302b may be reduced to allow clearance for septum 1332a within housing 1302.

[0052] FIG. 32 is a cross-sectional view of a needleless connector 1400 according to various aspects of the present disclosure. FIG. 33 is a partial cross-sectional view of a collar 1402b1 according to various aspects of the present disclosure. FIG. 34 is a partial cross-sectional view of a housing portion according to various aspects of the present disclosure. FIG. 35 is a cross-sectional view of a flexible valve element 1430 according to various aspects of the present disclosure. In some embodiments, the needleless connector 1400 can include similar features to the needleless connector 1300. Accordingly, certain features of the needleless connector 1400 can be referred to using similar reference numerals. Similar to the needleless connector 1300, the housing 1402 can provide a gap between the outer portion 1402a of the housing and the collar 1402b of the housing 1402. In some embodiments, an elongated septum 1432a extending from the diaphragm 1432 of the flexible valve element 1430 can extend into the gap defined between the housing 1402a and the collar 1402b. As illustrated, the diameter of 1402b may be reduced to allow clearance for septum 1432a within housing 1402.

[0053] As illustrated, the upper portion of the collar 1402b1 can be separated or disassembled from the lower portion or base 1402b2 to allow the needleless connector 1400 to be modular or configured.

[0054]

[0041] Figure 36 is a cross-sectional view of needleless connector 1500 according to various aspects of the present disclosure. Figure 37 is a detailed cross-sectional view of needleless connector 1500 according to various aspects of the present disclosure. Figure 38 is a perspective view of collar 1502c according to various aspects of the present disclosure. Figure 39 is a partial cross-sectional view of collar 1502c according to various aspects of the present disclosure. In some embodiments, needleless connector 1500 can include similar features as needleless connector 200. Accordingly, certain features of needleless connector 1500 can be referred to using similar reference numerals.

[0055] In the illustrated example, the housing 1502 may hold or capture the flexible valve element 1530 relative to the housing 1502 to maintain sterility of the fluid path and maintain the position of the diaphragm 1532 relative to the housing 1502. In some embodiments, the housing 1502 may include a collar or snap ring 1502c for capturing and retaining the diaphragm 1532 of the flexible valve element 1530. As illustrated, the diaphragm 1532 may be captured in a channel 1502c1 in the snap ring 1502c. In some embodiments, fluid may form a liquid column above the diaphragm 1532 and air may form an air column below the diaphragm 1532.

[0056] 40 is a cross-sectional view of a needleless connector 1600 according to various aspects of the present disclosure. In some embodiments, the needleless connector 1600 may include similar features as the needleless connector 100. Accordingly, certain features of the needleless connector 1600 may be referred to using similar reference numerals.

[0057] In the illustrated example, the housing 1602 can define one or more flow channels 1607 to facilitate cleaning of the needleless connector 1600. In some embodiments, the housing 1602 can define a single flow channel 1607 with a support ring. In some cases, the housing 1602 and support ring can define multiple flow channels.

[0058] 41 is a cross-sectional view of a needleless connector 1700 according to various aspects of the present disclosure. In some embodiments, the needleless connector 1700 may include similar features as the needleless connector 100. Accordingly, certain features of the needleless connector 1700 may be referred to using similar reference numerals.

[0059] In the illustrated example, the housing 1702 may define a plurality of smaller flow channels 1707 to facilitate cleaning of the needleless connector 1700. In some embodiments, the housing 1702 may define the flow channels 1707 without the use of a support ring.

[0060] FIG. 42 is a cross-sectional view of needleless connector 1800 according to various aspects of the present disclosure. FIG. 43 is a detailed view of housing portion 1802b according to various aspects of the present disclosure. FIG. 44 is a detailed view of housing portion 1802b according to various aspects of the present disclosure. FIG. 45 is a detailed cross-sectional view of needleless connector 1800 according to various aspects of the present disclosure. In some embodiments, needleless connector 1800 can include similar features as needleless connector 100. Accordingly, certain features of needleless connector 1800 can be referred to using similar reference numerals.

[0061] In the illustrated example, the housing 1802 may define one or more flow channels 1807 to facilitate cleaning of the needleless connector 1800. In some embodiments, the housing 1802 is a two-part housing defining the flow channel 1807 between two parts of the housing 1802. As illustrated, the flow channel 1807 may be defined between the outer portion 1802a and the inner portion 1802b of the housing. In some embodiments, the flow channel 1807 may be defined and / or encompassed by a crush rib 1807a extending from the surface of the inner portion 1802b to prevent fluid from leaking into other parts of the housing 1802 or to the exterior.

[0062] As illustrated, crush ribs 1807a may be molded into portions of inner housing 1802b and engage (via an interference fit) with the interior geometry of outer housing 1802a to form a liquid-tight barrier. In some embodiments, fluid may form a column of liquid up within flow channel 1807.

[0063] Examples of subject matter art as clauses The subject technology is exemplified by various aspects described below, for example. 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 do not limit the subject technology. Note that any of the dependent clauses may be combined in any combination and incorporated into their respective independent clauses, e.g., clause 1 or clause 5. Other clauses may be presented similarly.

[0064] Clause 1. A needleless connector having a housing having a cavity, a proximal fluid port in fluid communication with the cavity, and a distal fluid port in fluid communication with the cavity, and a flexible valve element disposed within the cavity to selectively allow flow between the proximal fluid port and the distal fluid port.

[0065] Clause 2. A needleless connector as described in Clause 1, wherein the flexible valve element has a valve diaphragm configured to expand when a luer is inserted into the proximal fluid port and to contract when the luer is removed from the proximal fluid port.

[0066] Clause 3. The needleless connector of clause 2, wherein the flexible valve element has a conical portion connected to the valve diaphragm and extending toward the proximal fluid port.

[0067] Clause 4. The needleless connector of clause 2, wherein the flexible valve element has a shroud connected to the valve diaphragm and extending toward the distal fluid port.

[0068] Clause 5. The needleless connector of clause 2, wherein the valve diaphragm defines a flat portion.

[0069] Clause 6. The needleless connector of clause 2, wherein the valve diaphragm is asymmetric.

[0070] Clause 7. The needleless connector of clause 2, wherein the valve diaphragm has a retention edge, at least a portion of which is captured within the housing.

[0071] Clause 8. The needleless connector of clause 7, wherein the retention edge is deformed within the housing.

[0072] Clause 9. A needleless connector as described in clause 1, wherein the flexible valve element has a valve tail extending into the cavity, the valve tail deflecting to selectively allow flow between the proximal fluid port and the distal fluid port.

[0073] Clause 10. The needleless connector of clause 9, wherein the valve tail has multiple bends.

[0074] Clause 11. The needleless connector of clause 9, wherein the valve tail is configured to allow flow between the proximal and distal fluid ports with minimal luer insertion force.

[0075] Clause 12. The needleless connector of clause 1, wherein the housing has a proximal portion and a distal portion, and the proximal portion and the distal portion are connected together.

[0076] Clause 13. The needleless connector of clause 12, wherein at least one of the proximal and distal portions comprises polypropylene or polyethylene.

[0077] Clause 14. The needleless connector of clause 12, wherein at least one of the proximal and distal portions comprises polycarbonate or a copolyester.

[0078] Clause 15. The needleless connector of clause 12, wherein the proximal and distal portions are connected via a press fit or snap fit.

[0079] Clause 16. The needleless connector of clause 12, wherein the proximal and distal portions are connected via adhesive or ultrasonic welding.

[0080] Clause 17. The needleless connector of clause 12, further comprising a snap ring configured to connect the proximal portion and the distal portion.

[0081] Clause 18. The needleless connector of clause 1, wherein the housing defines at least one flow channel in fluid communication with the proximal fluid port and the distal fluid port.

[0082] Clause 19. The needleless connector of clause 1, wherein the distal fluid port is laterally offset relative to the proximal fluid port.

[0083] Clause 20. A needleless connector having a housing having a proximal portion, a distal portion, the proximal portion and the distal portion connected together and cooperatively defining a cavity, a proximal fluid port in fluid communication with the cavity, and a distal fluid port in fluid communication with the cavity, a valve diaphragm configured to expand when a luer is inserted into the proximal fluid port and to contract when the luer is removed from the proximal fluid port, a cone connected to the valve diaphragm and extending toward the proximal fluid port, a retention edge, at least a portion of which is captured within the housing, and a flexible valve element having a valve tail extending into the cavity that deflects to selectively allow flow between the proximal and distal fluid ports.

[0084] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0085] Reference to a singular element is not intended to mean "one" unless specifically so stated, but rather "one or more." The term "some" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and non-gendered (e.g., her and its), and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

[0086] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0087] The use of a phrase such as "aspect" 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 of an aspect may apply to all configurations or 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 embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure of an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. A phrase such as an embodiment may refer to one or more embodiments, and vice versa. A phrase such as "configuration" does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. Disclosure of a configuration may apply to all configurations or 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.

[0088] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth herein, including those in the following claims, are approximate and not precise, and are intended to have a reasonable range consistent with the function to which they relate and the practice in the art to which they pertain.

[0089] In one aspect, the term "coupled" or the like can refer to being directly coupled. In another aspect, the term "coupled" or the like can refer to being indirectly coupled.

[0090] The terms "upper," "lower," "front," "rear," etc., as used in this disclosure, should be understood to refer to an arbitrary frame of reference, rather than the typical gravitational frame of reference. Thus, upper, lower, front, and rear surfaces may extend upward, downward, diagonally, or horizontally in the gravitational frame of reference.

[0091] Various things may be arranged differently (e.g., arranged in a different order or divided in a different way) without all departing from the scope of the subject technology. All structural and functional equivalents 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 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 element of a claim is to be construed under the provisions of 35 U.S.C. 112, sixth paragraph, unless that element is expressly recited using the phrase "means for," or, in the case of a method claim, using the phrase "step for." Furthermore, when the terms "comprise," "include," "have," and the like are used, such terms are intended to be inclusive in the same manner as "comprise," as the term "comprise" is interpreted when used as a transitional phrase in a claim.

[0092] The "Title," "Background," "Summary," "Brief Description of the Drawings," and "Abstract" sections of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. This disclosure is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the "Description," it will be recognized that the description provides illustrative examples, and that various features are 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 the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into this "Description," with each claim standing on its own as separately claimed subject matter.

[0093] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the widest scope consistent with the language of the claims and encompass all legal equivalents. However, no claim is intended to, and should not be construed as, encompassing subject matter that does not comply with the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. a housing having a cavity, a proximal fluid port in fluid communication with the cavity, and a distal fluid port in fluid communication with the cavity; a flexible valve element disposed within the cavity to selectively allow flow between the proximal fluid port and the distal fluid port; A needleless connector having

2. 2. The needleless connector of claim 1, wherein the flexible valve element has a valve diaphragm configured to expand when a luer is inserted into the proximal fluid port and to contract when the luer is removed from the proximal fluid port.

3. The needleless connector of claim 2 , wherein the flexible valve element has a cone connected to the valve diaphragm and extending toward the proximal fluid port.

4. The needleless connector of claim 2 , wherein the flexible valve element has a shroud coupled to the valve diaphragm and extending toward the distal fluid port.

5. The needleless connector of claim 2 , wherein the valve diaphragm defines a flat portion.

6. The needleless connector of claim 2 , wherein the valve diaphragm is asymmetric.

7. The needleless connector of claim 2 , wherein the valve diaphragm has a retention edge, at least a portion of the retention edge being captured within the housing.

8. The needleless connector of claim 7 , wherein the retention edge is deformed within the housing.

9. The needleless connector of claim 1 , wherein the flexible valve element has a valve tail that extends into the cavity, the valve tail deflecting to selectively allow flow between the proximal and distal fluid ports.

10. The needleless connector of claim 9 , wherein the valve tail has multiple bends.

11. The needleless connector of claim 9 , wherein the valve tail is configured to minimize luer insertion force, thereby allowing flow between the proximal and distal fluid ports.

12. The needleless connector of claim 1 , wherein the housing has a proximal portion and a distal portion, the proximal portion and the distal portion being connected together.

13. The needleless connector of claim 12 , wherein at least one of the proximal portion and the distal portion comprises polypropylene or polyethylene.

14. The needleless connector of claim 12 , wherein at least one of the proximal portion and the distal portion comprises polycarbonate or a copolyester.

15. The needleless connector of claim 12 , wherein the proximal portion and the distal portion are connected by a press fit or a snap fit.

16. The needleless connector of claim 12 , wherein the proximal portion and the distal portion are connected by adhesive or ultrasonic welding.

17. The needleless connector of claim 12 , further comprising a snap ring configured to connect the proximal portion and the distal portion.

18. The needleless connector of claim 1 , wherein the housing defines at least one flow channel in fluid communication with the proximal fluid port and the distal fluid port.

19. The needleless connector of claim 1 , wherein the distal fluid port is laterally offset relative to the proximal fluid port.

20. A housing, a proximal portion; a distal portion, the proximal portion and the distal portion being coupled together to cooperatively define a cavity; a proximal fluid port in fluid communication with the cavity; a distal fluid port in fluid communication with the cavity; a housing having a flexible valve element, a valve diaphragm configured to expand when a luer is inserted into the proximal fluid port and to contract when the luer is removed from the proximal fluid port; a cone connected to the valve diaphragm and extending toward the proximal fluid port; a retaining edge, at least a portion of which is captured within the housing; a valve tail extending into the cavity, the valve tail deflecting to selectively allow flow between the proximal and distal fluid ports; a flexible valve element having A needleless connector having

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