Needleless connector with flexible valve element

Abstract

The utility model describes a kind of needleless connector and flexible valve element.No needle connector it can include shell and flexible valve element, flexible valve element is positioned in the cavity of needleless connector, to selectively allow the flow between the proximal fluid port and the distal fluid port of shell, and flexible valve element includes valve head, valve stem and valve septum, flexible valve element further includes the feature of the barrier that prevents the fluid flow between valve head and valve septum, including the fluid flow path along the shoulder of valve head and any one in valve septum, wherein fluid flow path can be formed by any one of passage and rib portion.Flexible valve element can further include the septum formed as bellow, to prevent or reduce strain on flexible valve element when needleless connector is activated.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 709,032, entitled “NEEDLELESS CONNECTOR,” filed on October 18, 2024, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates generally to connectors, and more particularly to pinless connectors and flexible valve elements. Background Technology

[0004] Medical treatments typically involve infusing medical fluids (e.g., saline solutions or liquid medications) into a patient using an intravenous (IV) conduit. This IV conduit is connected to a fluid source, such as an IV bag, via an arrangement of flexible tubing and fittings commonly referred to as an "IV kit." Certain needle-free connectors can be used in IV kits and may have self-sealing ports to prevent fluid leakage when the mating medical device is detached from such a needle-free connector. Furthermore, needle-free connectors may include mechanical valves, such as collapsible valves, which incorporate flexible material for providing a self-sealing port and controlling the flow rate of fluid within the IV kit.

[0005] In some applications, pinless connectors may retain or trap fluid within the connector, or may have dead spots where fluid cannot move through the connector. In certain situations, pinless connectors may not function as expected due to strain or wear on the folding valve. Utility Model Content

[0006] The disclosed subject matter relates to connectors with improved valve elements and housings. In some embodiments, a pinless connector is disclosed, comprising: a housing including 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 and distal fluid ports.

[0007] In some embodiments, a pinless connector is disclosed, comprising: a housing including an inner surface forming a cavity, a proximal fluid port fluidly connected to the cavity, and a distal fluid port fluidly connected to the cavity; and a flexible valve element including a valve head, a valve stem, and a valve diaphragm, the valve head having a first end, a second end, and a shoulder between the first and second ends, the valve stem extending from the valve head in a direction remote from the first end of the valve head, and the valve diaphragm extending radially outward between the shoulder and the valve stem and in a direction remote from the second end of the valve head, wherein a fluid flow path extends along either the shoulder or the valve diaphragm, wherein a valve is positioned within the housing, the periphery of the valve diaphragm is coupled to the housing to divide the cavity into a fluid cavity portion and an air cavity portion, and the valve head is positioned in the fluid cavity portion, and the valve stem is positioned in the air cavity portion, wherein the fluid cavity portion is isolated from the air cavity portion.

[0008] In some cases, this disclosure provides a flexible valve element for a pinless connector, the flexible valve element comprising: a valve head having a first end, a second end, a shoulder between the first end and the second end, and a neck between the first end and the shoulder, wherein the shoulder includes a channel extending longitudinally between the first end and the second end of the valve head; a valve stem extending from the valve head in a direction away from the first end of the valve head; and a valve diaphragm between the shoulder and the valve stem, the valve diaphragm extending radially outward in a direction away from the second end of the valve head.

[0009] In some cases, this disclosure provides a flexible valve element for a pinless connector, the valve comprising: a valve head made of a first material having a first end, a second end, a shoulder between the first end and the second end, and a neck between the first end and the shoulder; a valve stem extending from the valve head in a direction away from the first end of the valve head; and a valve diaphragm between the shoulder and the valve stem, the valve diaphragm extending radially outward in a direction away from the second end of the valve head, wherein the valve diaphragm is made of a second material different from the first material.

[0010] Therefore, this application addresses several operational challenges encountered in existing fluid connections and provides numerous improvements that enable users to enhance safety and effectiveness while providing needle-free connectors more easily and accurately, allowing fluid to flow through them more completely.

[0011] Additional features and advantages of the present subject matter will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present subject matter. The advantages of the present subject matter will be realized and obtained through the written description and embodiments, and the structures specifically pointed out in the accompanying drawings.

[0012] It should be understood that the general description above and the detailed description below are exemplary and illustrative, and are intended to provide further explanation of the technical subject matter. Attached Figure Description

[0013] The following description, with reference to the accompanying drawings, illustrates various features of illustrative embodiments of the present invention. The illustrated embodiments are intended to explain, and not limit, the present invention. The drawings include the following figures:

[0014] Figure 1 A needleless connector for use with an IV kit coupled to a patient is shown according to various aspects of this disclosure.

[0015] Figure 2 This is a cross-sectional view of a pinless connector according to different aspects of this disclosure.

[0016] Figure 3 This is a cross-sectional view of another pinless connector according to different aspects of this disclosure.

[0017] Figure 4 This is a front perspective view of a flexible valve element according to various aspects of this disclosure.

[0018] Figure 5 This is a front perspective view of another flexible valve element according to a different aspect of this disclosure.

[0019] Figure 6 Based on different aspects of this disclosure Figure 5 A partial cross-sectional view of the pinless connector and flexible valve element shown.

[0020] Figure 7 This is a front perspective view of another flexible valve element according to a different aspect of this disclosure.

[0021] Figure 8 Based on different aspects of this disclosure Figure 7 A partial cross-sectional view of the pinless connector and flexible valve element shown. Detailed Implementation

[0022] The disclosed pinless connector incorporates various features to facilitate connector connection, filling, flushing, and / or disconnection. These features may include, but are not limited to, features of a flexible valve element, which may include a valve head, valve diaphragm, and valve stem. By providing a pinless connector with one or more of these features, the pinless connector offers improved connection, filling, flushing, and / or disconnection operations compared to conventional pinless connectors.

[0023] In the following detailed description, numerous specific details are set forth to provide a full understanding of the subject matter. It should be understood that the subject matter can be practiced without these specific details. In other instances, well-known structures and techniques are not shown in detail to avoid obscuring the subject matter.

[0024] Furthermore, while this specification sets forth specific details of various embodiments, it should be understood that this specification is illustrative only and should not be construed as restrictive in any way. Moreover, it is conceivable that although the following description pertains to the delivery of medical fluids to a patient by a medical practitioner 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 can be used in any application where it is desirable to prevent the spread of bacteria, microorganisms, and other pathogens while allowing the aspiration of blood and other fluids from a subject or patient.

[0025] The disclosed pinless connector overcomes several challenges faced by certain conventional connectors. One challenge of certain conventional pinless self-sealing connectors is that fluid may be trapped within the connector or its valve portion, potentially creating areas that impede fluid flow and thus reducing the ability of fluid to flush or move through the connector. Another challenge of certain conventional pinless self-sealing connectors is that some may include valve elements that could be damaged or cease to function as intended due to strain or wear.

[0026] Therefore, according to this disclosure, a pinless connector as described herein is advantageously provided, which facilitates connection, filling, flushing, and disconnection. Furthermore, a pinless connector as described herein is advantageously provided, which may include features that are flexible and easy to manufacture.

[0027] Now refer to the attached diagram, Figure 1 Examples of needleless connectors used according to various aspects of this disclosure are shown. Needleless connectors 100, 102 are shown coupled to a Y-tee 20 used to direct fluid to a patient 10. The IV kit may include a medication bag 12, an infusion chamber 14, a fitting 16, and an IV tubing 18.

[0028] A first pinless connector 100 is connected between the first branch of the Y-tee 20 and the fitting 16 of the IV assembly, such that the pinless connector 100 is activated and allows fluid to flow from the fitting 16 through the pinless connector 100 into the IV conduit 18. A second pinless connector 102 is connected to the second branch of the Y-tee 20 and is not activated, such that the pinless connector 102 prevents fluid from flowing into or out of the Y-tee 20.

[0029] When the needleless connectors 100 and 102 are activated, such as by connecting them to another connector, Luer fitting, or syringe, a flexible valve element within the needleless connector is biased or compressed to open a fluid path through the connector. The flexible valve element is configured to prevent the formation of fluid flow stagnation zones or fluid recesses when the needleless connectors 100 and 102 are activated and compressed. Therefore, the flexible valve element is configured to allow fluid to be flushed or moved through the activated needleless connectors 100 and 102 while preventing flow stagnation zones or recesses where fluid might be trapped or flow flow might be obstructed. Furthermore, features of the needleless connectors in this disclosure can prevent damage to the flexible valve element during use, such as tearing or accidental deformation.

[0030] Figure 2 and Figure 3 This is a cross-sectional view of a pinless connector according to different aspects of this disclosure. Figure 2 It is a pinless connector 100 configured as a positive displacement connector. Figure 3 The pinless connector 102 is configured as a negative displacement connector. Each of the pinless connectors includes a housing 110 and a flexible valve element 200 positioned within the housing. As shown, the pinless connectors 100, 102 are not activated, such that a portion of the flexible valve element 200 blocks the fluid path through the pinless connector to prevent fluid movement through it.

[0031] The housing 110 includes an inner surface 112 that forms a cavity 114 in a pinless connector, the cavity being configured to receive at least a portion of a flexible valve element therein. The cavity 114 is fluidly coupled to fluid ports of the housing 110, including a proximal fluid port 116 and a distal fluid port 118.

[0032] As shown, fluid flow from the IV kit can flow to the patient via the proximal fluid port 116, through the housing 110, and through the distal fluid port 118. Furthermore, in some embodiments, blood and other fluids from the patient can be aspirated from the distal fluid port 118 through the housing 110 to the proximal fluid port 116. As shown, the proximal and distal fluid ports 116 can include any suitable fittings, including but not limited to Luer fittings. In the described example, the proximal fluid port 116 is shown as a female or sleeve Luer fitting, and the distal fluid port 118 is shown as a male or pin Luer fitting.

[0033] like Figure 2 and Figure 3 The pinless connectors 100 and 102 are shown, and refer to... Figure 4The flexible valve element 200 shown allows or restricts flow through the proximal fluid port 116 by selectively sealing the cavity 114 of the housing. The flexible valve element 200 includes a valve head 212 having a sealing surface 214 facing a first end 216 of the flexible valve element, a shoulder 218 between the first and second ends of the valve head, and a neck 220 extending between the first end 216 and the shoulder 218 of the valve head.

[0034] When the pinless connector is not activated, the flexible valve element 200 is positioned such that the valve head 212 is at least partially located within the proximal fluid port 116, such that the sealing surface and shoulder 218 of the flexible valve element abut against the inner surface 112 of the housing to seal the proximal fluid port 116 and prevent fluid from moving through the proximal fluid port 116.

[0035] The valve head 212 may further include one or more slit portions 222 to facilitate flow through the flexible valve element 200 by easily deforming along one or more slit portions 222 when the mating medical device is inserted into the needleless connector.

[0036] The flexible valve element 200 also includes a valve stem 240 extending from a second end 224 of the valve head in a direction away from a first end 216 of the valve head. When the flexible valve element 200 is positioned within a pinless connector, the distal end 242 of the valve stem engages against the housing 110, thereby positioning the valve head in the proximal fluid port 116. Furthermore, the valve stem 240 prevents movement of the valve head 212 toward the distal fluid port 118.

[0037] The flexible valve element 200 further includes a diaphragm 260 positioned near a second end 224 of the valve head and extending radially outward in a direction away from the second end 224 of the valve head. The valve diaphragm 260 includes a proximal end 262 and a distal end 264. The proximal end 262 of the valve diaphragm is coupled to the valve head such that the valve diaphragm extends radially outward from the valve head to the distal end 264 of the valve diaphragm. The proximal end 262 of the valve diaphragm is positioned between the second end 224 of the valve head and the valve stem 240. In some embodiments, it is conceivable that the proximal end 262 of the valve diaphragm may be located between a shoulder of the valve head and the second end 224 of the valve head.

[0038] When the valve diaphragm 260 is in the neutral or unextended position, the valve diaphragm 260 has a length L1 from the proximal end 262 of the valve diaphragm to the distal end 264 of the valve diaphragm. When the valve diaphragm is extended in the longitudinal direction between the proximal end 262 and the distal end 264, the valve diaphragm 260 may have a length L2 that is longer than the length L1.

[0039] The distal end 264 of the valve diaphragm forms a circumference or periphery extending around the outer surface of the valve head and can be coupled to a portion of the housing 110. The valve diaphragm 260 has a tapered shape, and the cross-sectional width of the valve diaphragm increases in the direction from the proximal end 262 toward the distal end 264. Although the valve diaphragm 260 is shown extending from the proximal end 262 to the distal end 264 in a direction away from the first end 216 of the valve head and along the valve stem 240, it is conceivable that the valve diaphragm can be configured to extend radially outward to form a planar shape, or it can extend radially outward in a direction toward the first end 216 of the valve head.

[0040] The valve diaphragm 260 is configured to engage with a portion of the housing to divide the cavity 114 into a fluid cavity portion 120 and an air cavity portion 122, wherein the fluid cavity portion 120 and the air cavity portion 122 are fluidly isolated. To divide the cavity 114 into the fluid cavity portion 120 and the air cavity portion 122, the distal end 264 of the valve diaphragm is engaged with a wall 124 within the housing, which forms a valve seat for a flexible valve element.

[0041] The air cavity portion 122 is formed or defined by the inner surface of the wall 124, the lower surface of the valve diaphragm 260, and the outer surface of the valve stem 240. In some embodiments of this disclosure, the housing 110 includes an air passage 126 extending from the air cavity portion 122 to the surrounding atmosphere adjacent to the outer surface of the housing, and the pinless connector 100 serves as a positive displacement device. Figure 2 In embodiments of this disclosure, the air cavity portion 122 is isolated from the surrounding atmosphere adjacent to the outer surface of the housing, and the pinless connector 102 serves as a negative displacement device. Figure 3 ).

[0042] The fluid cavity portion 120 is formed or defined by the inner surface 112 of the housing, the outer surface of the wall 124, the outer surface of the valve head 212, and the upper surface 266 of the valve diaphragm. When the pinless connector is activated, the fluid cavity portion 120 also forms at least a portion of a fluid path extending from the proximal fluid port 116 to the distal fluid port 118.

[0043] During operation of the needleless connector, a male fitting of the medical device can be introduced into the proximal fluid port 116 to activate the needleless connector. When the male fitting is introduced into the proximal fluid port 116, the flexible valve element 200 can have sufficient elasticity to deform or bend away from the sealing engagement with the inner surface 112 of the housing, thereby allowing fluid to flow between the needleless connector and the medical device. When the needleless connector is activated, fluid can flow along the fluid path of the fluid cavity portion 120 between the proximal fluid port 116 and the distal fluid port 118.

[0044] When the male fitting is disconnected from the proximal fluid port 116, the flexible valve element 200 can return to its original shape, causing the valve head 212 to extend into the proximal fluid port 116, thus deactivating the pinless connector. When the pinless connector is deactivated, the fluid chamber portion 120 remains isolated from the air chamber portion 122 and the proximal fluid port 116.

[0045] exist Figure 2 In the example of the positive displacement device shown, the volume of the air cavity portion 122 is reduced such that when the male fitting is inserted into the proximal fluid port 116, fluid is drawn from either the proximal fluid port 116 or the distal fluid port 118. When the male fitting is removed from the proximal fluid port 116, fluid is discharged from the fluid cavity portion 120, thereby flushing the pinless connector 100.

[0046] The flexible valve element 200 may be formed of silicone or other elastic materials to elastically deform when the pinless connector is activated and to reform when the pinless connector is not activated to allow a seal at the proximal fluid port 116. When the pinless connector is activated, either the valve head 212 or the valve stem 240 may be compressed, bent, folded, or twisted such that the valve head 212 moves longitudinally away from the proximal fluid port 116 and closer to the distal fluid port 118. As the valve head 212 moves toward the distal fluid port 118, the valve diaphragm 260 extends radially such that the valve diaphragm 260 has a length L2 greater than the length L1.

[0047] The flexible valve element 200 can be formed of more than one material, or it can be formed of a material with different properties in different portions of the flexible valve element. In some embodiments of this disclosure, the valve head 212 may include a first hardness grade, and the valve diaphragm 260 may include a second hardness grade, wherein the second hardness grade is lower than the first hardness grade. In one example, the valve head 212 is formed of a first material having the first hardness grade, and the valve diaphragm 260 is formed of a second material having the second hardness grade, wherein the first material is different from the second material, and the first and second hardness grades are different. In another example, the different first and second hardness grades can be achieved by forming a valve diaphragm 260 with a thickness less than the thickness of the valve head 212.

[0048] The flexible valve element 200 can be formed as a single component, with the valve head 212, valve stem 240, and valve diaphragm 260 formed as a single and individual component. In some cases, one or more portions of the flexible valve element 200 can be formed separately and coupled to other portions of the flexible valve element 200 during manufacturing and / or use of subsequent processing steps. For example, the valve diaphragm 260 can be overmolded or otherwise coupled to either the valve head 212 or the valve stem 240.

[0049] In some embodiments of this disclosure, a portion of the flexible valve element may include structures or features that provide a fluid flow path along the surface of the flexible valve element. The flexible valve element may be configured such that when the pinless connector is activated, the fluid flow path prevents or reduces the possibility of fluid being trapped or blocked in or around the flexible valve element.

[0050] The fluid flow path can be formed by ridges and / or channels extending along any upper surface 266 of the valve head 212 and / or the valve diaphragm. Ridges can be shaped as convex surfaces (e.g., ribs), and channels can be shaped as concave surfaces (e.g., grooves). In any case, the fluid flow path is configured to allow fluid to move between the valve head 212 and the upper surface 266 of the valve diaphragm. When the pinless connector is activated, the valve head 212 can be compressed or folded toward the valve diaphragm 260. Furthermore, when the upper surface 266 of the valve diaphragm engages against the valve head 212, the fluid flow path can allow fluid to move along recesses or areas where fluid might be trapped, thereby ensuring and increasing the reliability of flushing or moving fluid through the pinless connector.

[0051] Figure 5 An exemplary embodiment of a flexible valve element 300 is shown, the flexible valve element having a channel 372 extending along a valve head and a rib 374 extending along a valve diaphragm. The flexible valve element 300 includes features similar to... Figures 2-4 Features of the flexible valve element 200 shown. Therefore, some features of the flexible valve element 300 are indicated by reference numerals similar to those of the flexible valve element 200.

[0052] The channel 372 extends longitudinally along at least a portion of the shoulder 218 between the first end 216 and the second end 224 of the valve head. The shoulder includes a top surface 376 facing the neck 220 of the valve head and a bottom surface 380 facing the valve diaphragm 260. The top surface 376 of the shoulder extends radially outward in a direction away from the neck 220 to the apex 378 of the shoulder. The bottom surface 380 of the shoulder extends radially outward in a direction away from the second end 224 of the valve head to the apex 278.

[0053] In some embodiments of this disclosure, for example Figure 5In the example shown, channel 372 extends longitudinally along the bottom surface 380 of shoulder 218 between the second end 224 of the valve and the apex 378 of the shoulder. Channel 372 may terminate before or extend through the apex 378 of the shoulder. In some embodiments of this disclosure, channel 372 extends only along the bottom surface 380 and the apex 378 of the shoulder.

[0054] Ribs 374 extend longitudinally along the upper surface 266 of the valve diaphragm between the valve head 212 and the distal end 264 of the valve diaphragm. The valve diaphragm 260 includes a plurality of ribs 374 radially spaced around its circumference. The plurality of ribs 374 are spaced apart from each other, and the spacing between adjacent ribs 374 is equal; however, embodiments with different or unequal spacing between adjacent ribs 374 are contemplated in this disclosure.

[0055] Furthermore, the plurality of ribs 374 may be positioned relative to the plurality of channels 372 on the circumference of the shoulder 218. In some embodiments of this disclosure, the plurality of ribs 374 on the valve diaphragm are radially offset from the plurality of channels 372 on the shoulder. In some embodiments, the plurality of ribs 374 on the valve diaphragm are radially aligned with the plurality of channels 372 on the shoulder.

[0056] This disclosure also contemplates embodiments in which the flexible valve element includes only one of the features of channel 372 or rib 374, as well as embodiments in which the flexible valve element includes a combination of channel 372 and rib 374. For example, the flexible valve element may include one or more channels 372 extending along either shoulder 218 and / or valve diaphragm 260, and has no rib 374. In another example, the flexible valve element may include one or more ribs 374 extending along either shoulder 218 and / or valve diaphragm 260, and has no channel 372. In yet another example, the flexible valve element may include one or more channels 372 and one or more ribs 374 extending along either shoulder 218 and / or valve diaphragm 260.

[0057] In another exemplary embodiment of this disclosure, the channel 372 and the rib 374 may be formed by another shape that allows fluid to move relative to the flexible valve element. For example, the channel 372 may be formed as a recess or pit extending into the surface of the valve diaphragm 260 and / or the shoulder 218. In another example, the rib 374 may be formed as a convex surface or protrusion extending away from the surface of the valve diaphragm 260 and / or the shoulder 218.

[0058] Reference Figure 6This diagram illustrates a portion of the flexible valve element 300 when the pinless connector is activated by the male fitting 30. The valve head 212 is axially compressed in the direction toward the valve stem 240. A first circumferential portion 213A of the valve head is folded along the neck 220, and a second circumferential portion 213B of the valve head extends. Furthermore, a first portion 265A of the valve diaphragm extends longitudinally, and a second portion 265B of the valve diaphragm is folded. Each of the first and second portions 265A of the valve diaphragm engages against the shoulder 218 of the valve head. Although the area of ​​the valve diaphragm 260 engaging against the shoulder 218 forms a stagnation zone or recess that impedes fluid flow, the fluid flow path formed by the channel 372 and the rib 374 allows fluid to flow between the valve diaphragm 260 and the valve head 212, thereby improving the ability and efficiency of fluid flow through the pinless connector.

[0059] In some embodiments of this disclosure, the valve diaphragm can be configured to prevent strain when the pinless connector is activated, thereby preventing potential damage and unintended performance of the flexible valve element. For example... Figure 7 As shown, to prevent strain when the pinless connector is activated, embodiments of the flexible valve element 400 may include a valve diaphragm having the shape of a bellows 482. The flexible valve element 400 includes elements similar to... Figures 2-4 The flexible valve element 200 shown and Figure 5 and Figure 6 Features of the flexible valve element 300 shown. Therefore, some features of the flexible valve element 400 are indicated by reference numerals similar to those of the flexible valve elements 200 and 300.

[0060] A bellows 482 formed portion of the valve diaphragm extends between the valve head 212 and the distal end 264 located at the periphery of the valve diaphragm 460. The bellows 482 is formed by the corrugated cross-section of the valve diaphragm, forming concentric rings along at least the upper surface 266 of the valve diaphragm. When the valve diaphragm 460 is in a neutral or unstretched position, the valve diaphragm 460 has a length L1 from the proximal end 262 to the distal end 264 of the valve diaphragm. When the valve diaphragm 460 is biased, such as when the pinless connector is activated, a portion of the valve diaphragm 460 can be stretched, while another portion of the valve diaphragm 460 can be compressed or folded. In some embodiments of this disclosure, when the pinless connector is activated, at least a portion of the valve diaphragm 460 along the bellows 482 extends from length L1 to length L2, wherein length L2 is greater than length L1. In some embodiments of this disclosure, length L2 may be 175% greater than length L1.

[0061] Reference Figure 8The diagram shows the first portion of a flexible valve element 400 when the pinless connector is activated by the male fitting 30. The first portion 461A of the valve diaphragm extends longitudinally, and the second portion 461B of the valve diaphragm is folded. The longitudinally extended first portion 461A of the valve diaphragm may have a length L2, and the folded second portion 461B of the valve diaphragm may have a length L1.

[0062] Each of the first portion 461A and the second portion 461B of the valve diaphragm engages against the shoulder 218 of the valve head. Although the area of ​​engagement of the valve diaphragm 460 against the shoulder 218 may form a stagnation zone or recess that obstructs fluid flow, the fluid flow path formed by the channel 372 along the shoulder allows fluid to move between the valve diaphragm 460 and the valve head 212. Therefore, the flexible valve element 400 allows fluid to move through the pinless connector and prevents strain that would otherwise cause damage and unintended performance of the flexible valve element.

[0063] For convenience, various examples of various aspects of the subject matter are described below. These are provided by way of example and do not limit the subject matter. Furthermore, these examples can be combined in any combination and placed in appropriate embodiments.

[0064] A pinless connector includes: a housing including an inner surface forming a cavity, a proximal fluid port fluidly connected to the cavity, and a distal fluid port fluidly connected to the cavity; and a flexible valve element including a valve head, a valve stem, and a valve diaphragm, the valve head having a first end, a second end, and a shoulder between the first and second ends, the valve stem extending from the valve head in a direction away from the first end of the valve head, and the valve diaphragm extending radially outward between the shoulder and the valve stem in a direction away from the second end of the valve head, wherein a fluid flow path extends along either the shoulder or the valve diaphragm, wherein a valve is positioned in the housing, a periphery of the valve diaphragm is coupled to the housing to divide the cavity into a fluid cavity portion and an air cavity portion, and the valve head is positioned in the fluid cavity portion, and the valve stem is positioned in the air cavity portion, wherein the fluid cavity portion is isolated from the air cavity portion.

[0065] The shoulder includes a channel extending longitudinally between a first end of the valve head and a second end of the valve head, wherein a fluid flow path is formed by the channel.

[0066] The valve head includes a neck between a first end and a shoulder, and the shoulder includes a top surface and a bottom surface, the top surface extending radially outward to a apex in a direction away from the neck, and the bottom surface extending radially outward to a apex in a direction away from the second end of the valve head.

[0067] The channel extends along the bottom surface of the shoulder.

[0068] The valve diaphragm includes more than one rib extending along the valve diaphragm, and the fluid flow path is formed by the recessed surface between adjacent ribs of the more than one rib.

[0069] The valve diaphragm includes a bellows shape between the valve head and the periphery of the valve diaphragm.

[0070] The valve head comprises a first material, and the valve diaphragm comprises a second material different from the first material.

[0071] The valve head is made of a material with a first hardness tester hardness grade, and the valve diaphragm is made of a material with a second hardness tester hardness grade, wherein the second hardness tester hardness grade is lower than the first hardness tester hardness grade.

[0072] The valve stem includes multiple bends.

[0073] A flexible valve element for a pinless connector, the valve comprising: a valve head having a first end, a second end, a shoulder between the first end and the second end, and a neck between the first end and the shoulder, wherein the shoulder includes a channel extending longitudinally between the first end and the second end of the valve head; a valve stem extending from the valve head in a direction away from the first end of the valve head; and a valve diaphragm between the shoulder and the valve stem, the valve diaphragm extending radially outward in a direction away from the second end of the valve head.

[0074] The shoulder includes a top surface and a bottom surface, the top surface extending radially outward to a apex in a direction away from the neck, the bottom surface extending radially outward to a apex in a direction away from the second end of the valve head, and wherein a channel extends along the bottom surface of the shoulder.

[0075] The shoulder includes a top surface and a bottom surface, the top surface extending radially outward to a apex in a direction away from the neck, and the bottom surface extending radially outward to a apex in a direction away from the second end of the valve head, wherein a channel extends along the bottom surface of the shoulder.

[0076] The channel extends through the apex of the shoulder.

[0077] The channel does not extend along the top surface of the shoulder.

[0078] The valve diaphragm includes a periphery, a top surface, and ribs. The top surface faces the first end of the valve head and extends from the valve head to the periphery of the valve diaphragm. The ribs extend longitudinally between the valve head and the periphery of the valve diaphragm.

[0079] The valve diaphragm includes more than one rib that extends longitudinally along the top surface of the valve diaphragm and in a direction between the valve head and the periphery of the valve diaphragm.

[0080] The valve diaphragm includes a bellows shape between the valve head and the periphery of the valve diaphragm.

[0081] The valve head comprises a first material, and the valve diaphragm comprises a second material different from the first material.

[0082] A flexible valve element for a pinless connector, the valve comprising: a valve head made of a first material having a first end, a second end, a shoulder between the first end and the second end, and a neck between the first end and the shoulder; a valve stem extending from the valve head in a direction away from the first end of the valve head; and a valve diaphragm between the shoulder and the valve stem, the valve diaphragm extending radially outward in a direction away from the second end of the valve head, wherein the valve diaphragm is made of a second material different from the first material.

[0083] The first material includes a first hardness grade from a hardness tester, the second material includes a second hardness grade from a hardness tester, and the second hardness grade from a hardness tester is lower than the first hardness grade from a hardness tester.

[0084] The valve diaphragm is encapsulated and molded onto the valve head.

[0085] 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 matter, and the subject matter is not limited to these examples. Numerous modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0086] Unless otherwise expressly stated, elements referred to in the singular form are not intended to mean "one and only one," but rather "one or more." Unless otherwise expressly stated, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter genders (e.g., her and its), and vice versa. The use of titles and subtitles (if any) is for convenience only and does not limit the scope of this invention.

[0087] The term “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” should not be construed as preferred or advantageous to other aspects or designs. In one respect, the various alternative configurations and operations described herein may be considered at least equivalent.

[0088] For example, phrases like "aspect" do not imply that such an aspect is essential to the present subject matter, or that such an aspect applies to all configurations of the present subject matter. Disclosure relating to an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. For example, phrases like "an aspect" may refer to one or more aspects, and vice versa. For example, phrases like "an embodiment" do not imply that such an embodiment is essential to the present subject matter, or that such an embodiment applies to all constructions of the present subject matter. Disclosure relating to an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. For example, phrases like "an embodiment" may refer to one or more embodiments, and vice versa. For example, phrases like "configuration" do not imply that such a configuration is essential to the present subject matter, or that such a configuration applies to all configurations of the present subject matter. Disclosure relating to a configuration may apply to all configurations or one or more configurations. A configuration may provide one or more examples. The phrase "such construction" may refer to one or more constructions, and vice versa.

[0089] In one respect, unless otherwise stated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including those in the appended claims, are approximate rather than precise. In another respect, they are intended to have a reasonable range consistent with the functions they pertain to and with the custom of the art to which they belong.

[0090] In one respect, the term "linkage" can refer to a direct connection. In another respect, the term "linkage" can refer to an indirect connection.

[0091] For example, the terms “top,” “bottom,” “front,” “rear,” etc., used in this disclosure should be understood to refer to any frame of reference rather than a general gravitational frame of reference. Therefore, the top surface, bottom surface, front surface, and rear surface can extend upward, downward, diagonally, or horizontally in a gravitational frame of reference.

[0092] Various items may be arranged differently (e.g., in different orders or divided in different ways) without departing from the scope of the subject matter. All structural and functional equivalents of the elements throughout the various aspects described in this disclosure are known to or will be known to those skilled in the art, expressly incorporated herein by reference and intended to be covered by the claims. Furthermore, the disclosure herein is not intended to be made public, whether or not such disclosure is expressly recited in the claims. Under paragraph 6 of 35 USC §112(f), elements of a claim will not be interpreted unless the element is clearly stated using the phrase “means”, or, in the case of a method claim, the element is stated using the phrase “for the step of…”. Furthermore, the scope of the terms “comprising,” “having,” etc., is intended to be inclusive in a manner similar to the term “including,” as interpreted when “including” is used as a transitional word in a claim.

[0093] The title, background art, utility model description, description of drawings, and abstract of this disclosure are incorporated herein by reference and are provided as illustrative examples rather than as limiting descriptions. This application is filed on the understanding that they will not be used to limit the scope or meaning of the claims. Furthermore, in the detailed description, it will be apparent that the description provides illustrative examples, and various features are combined in various embodiments to simplify the disclosure. This disclosure approach should not be construed as reflecting an intention that the claimed subject matter requires more features than expressly stated in each claim. Rather, as reflected in the appended claims, the utility model subject matter lies in all features of fewer than those in a single disclosure configuration or operation. The appended claims are thus incorporated into the detailed description, wherein each claim is independently claimed as a separate subject matter.

[0094] The claims are not intended to be limited to the aspects described herein, but rather to conform to the full scope consistent with the language claims and to include all legal equivalents. Nevertheless, none of the claims are intended to include subject matter that fails to satisfy the requirements of 35 U.S.SC § 101, 102, or 103, nor should they be interpreted in this manner.

Claims

1. A pinless connector, characterized in that, include: The housing includes an inner surface forming a cavity, a proximal fluid port fluidly connected to the cavity, and a distal fluid port fluidly connected to the cavity; and A flexible valve element includes a valve head, a valve stem, and a valve diaphragm, the valve head having a first end, a second end, and a shoulder between the first and second ends, the valve stem extending from the valve head in a first direction away from the first end of the valve head, and the valve diaphragm extending radially outward between the shoulder and the valve stem and in a second direction away from the second end of the valve head, wherein a fluid flow path extends along either the shoulder or the valve diaphragm; The flexible valve element is positioned within a housing, the periphery of the valve diaphragm is connected to the housing to divide the cavity into a fluid cavity portion and an air cavity portion, the valve head is positioned in the fluid cavity portion, and the valve stem is positioned in the air cavity portion, wherein the fluid cavity portion is isolated from the air cavity portion.

2. The pinless connector according to claim 1, characterized in that, The shoulder includes a channel extending longitudinally between a first end of the valve head and a second end of the valve head, wherein the fluid flow path is formed by the channel.

3. The pinless connector according to claim 2, characterized in that, The valve head includes a neck between the first end and the shoulder, and the shoulder includes a top surface and a bottom surface, the top surface extending radially outward away from the neck to a apex, and the bottom surface extending radially outward away from the second end of the valve head to the apex.

4. The pinless connector according to claim 3, characterized in that, The channel extends along the bottom surface of the shoulder.

5. The pinless connector according to claim 1, characterized in that, The valve diaphragm includes more than one rib extending along the valve diaphragm, and the fluid flow path is formed by a recessed surface between adjacent ribs of the more than one rib.

6. The pinless connector according to claim 1, characterized in that, The valve diaphragm includes a bellows shape between the valve head and the periphery of the valve diaphragm.

7. The pinless connector according to claim 1, characterized in that, The valve head comprises a first material, and the valve diaphragm comprises a second material different from the first material.

8. The pinless connector according to claim 1, characterized in that, The valve head is made of a material with a first hardness tester hardness grade, and the valve diaphragm is made of a material with a second hardness tester hardness grade, wherein the second hardness tester hardness grade is lower than the first hardness tester hardness grade.

9. The pinless connector according to claim 1, characterized in that, The valve stem includes multiple bends.

10. A flexible valve element for pinless connectors, characterized in that, The flexible valve element includes: A valve head having a first end, a second end, a shoulder between the first end and the second end, and a neck between the first end and the shoulder, wherein the shoulder includes a channel extending longitudinally between the first end and the second end of the valve head; Valve stem, which extends from the valve head in a first direction away from a first end of the valve head; and A valve diaphragm between the shoulder and the valve stem extends radially outward in a second direction away from the second end of the valve head.

11. The flexible valve element according to claim 10, characterized in that, The shoulder includes a top surface and a bottom surface, the top surface extending radially outward to a apex in a direction away from the neck, and the bottom surface extending radially outward to the apex away from a second end of the valve head, wherein the channel extends along the bottom surface of the shoulder.

12. The flexible valve element according to claim 11, characterized in that, The channel extends through the apex of the shoulder.

13. The flexible valve element according to claim 11, characterized in that, The channel does not extend along the top surface of the shoulder.

14. The flexible valve element according to claim 10, characterized in that, The valve diaphragm includes a periphery, a top surface, and ribs. The top surface faces a first end of the valve head and extends from the valve head to the periphery of the valve diaphragm. The ribs extend longitudinally between the valve head and the periphery of the valve diaphragm.

15. The flexible valve element according to claim 10, characterized in that, The valve diaphragm includes more than one rib that extends longitudinally along the top surface of the valve diaphragm and in a direction between the valve head and the periphery of the valve diaphragm.

16. The flexible valve element according to claim 10, characterized in that, The valve diaphragm includes a bellows shape between the valve head and the periphery of the valve diaphragm.

17. The flexible valve element according to claim 10, characterized in that, The valve head comprises a first material, and the valve diaphragm comprises a second material different from the first material.

18. A flexible valve element for pinless connectors, characterized in that, The flexible valve element includes: A valve head made of a first material, the valve head having a first end, a second end, a shoulder between the first end and the second end, and a neck between the first end and the shoulder; Valve stem, which extends from the valve head in a first direction away from a first end of the valve head; and A valve diaphragm between the shoulder and the valve stem, the valve diaphragm extending radially outward in a second direction away from the second end of the valve head, wherein the valve diaphragm is made of a second material different from the first material.

19. The flexible valve element according to claim 18, characterized in that, The first material includes a first hardness grade from a hardness tester, the second material includes a second hardness grade from a hardness tester, and wherein the second hardness grade from the hardness tester is lower than the first hardness grade from the hardness tester.

20. The flexible valve element according to claim 18, characterized in that, The valve diaphragm is overmolded onto the valve head.

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