Needleless connector

Abstract

The present application relates to a needleless connector having a housing having a cavity and a central strut, and a valve having a head and a skirt wherein the valve is positioned within the cavity of the housing, the central strut extending into a passage through the valve, and the skirt extending away from the head of the valve to the housing, the skirt portion fluidly divides the cavity into a first portion and a second portion, and wherein an outer end of the skirt portion is spaced from one end of the cavity to allow the valve to move between a closed configuration and an open configuration such that in the open configuration, the skirt portion extends along the head and in a direction toward the first housing port, and in the second housing port, the skirt portion extends in a direction toward the second housing port. And the volume of the first portion of the cavity decreases as the valve moves from the open configuration toward the closed configuration to discharge any fluid accumulated therein.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to medical fluid connectors, and more particularly to needle-free connectors having a valve configured to prevent the unintended accumulation of fluid into the needle-free connector. BACKGROUND

[0002] Needle-free connectors, including those that include a neutral displacement, provide a solution for providing medical fluid to a patient in a safe, efficient, and effective manner. Needle-free connectors allow for the transmission of fluid through the connector, such as between a medical fluid supply and a catheter line, without the need for a needle to pierce a connector septum. In some instances, needle-free connectors include a larger internal volume, which can result in a significant amount of residual fluid being contained within the needle-free connector after use of the needle-free connector. Among other things, the significant amount of residual fluid that was otherwise intended to be administered to the patient is not actually administered to the patient and can result in contamination of the residual fluid and the needle-free connector.

[0003] The needle-free connector can include a valve positioned within the housing such that upon insertion of a medical connector into the needle-free connector, the valve moves to an open configuration and engagement of the medical connector against the valve forms a fluid path between the medical connector and a fluid passageway of the needle-free connector.

[0004] In certain instances, fluid can leak from the fluid passageway around or in the area where the medical connector abuts the valve, resulting in the unintended accumulation of fluid in the needle-free connector. The accumulation of fluid in the needle-free connector can degrade the performance of the needle-free connector, including causing the valve of the needle-free connector to fail to compress or return to a neutral position as intended. Additionally, the accumulated fluid can result in incomplete fluid or less than intended fluid flow through the needle-free connector. In certain instances, the accumulated fluid can result in the formation of a biofilm in the needle-free connector, which can subject the patient to a catheter-related infection. SUMMARY

[0005] According to at least some embodiments disclosed herein, it is recognized that the unintended accumulation of fluid in a needle-free connector can degrade the performance of the needle-free connector or cause it to fail. Additionally, the present disclosure contemplates that the unintended accumulation of fluid in a needle-free connector can be caused by a leak in the fluid path formed between the valve of the needle-free connector and a medical connector that is engaged against the valve. Furthermore, the present disclosure envisions features that allow for the observation of the interior of the needle-free connector, which can aid in the observation and identification of conditions that can result in the unintended performance of the needle-free connector.

[0006] Aspects of the present disclosure provide a needleless connector including a housing having a first housing port, a second housing port, a cavity extending through the first housing port to a cavity floor, and a central post extending into the cavity and toward the first housing port, the central post having an opening and an inner surface forming a lumen extending between the opening and the second housing port; and a valve including a head having an inner surface forming a passage through the head, and a skirt extending radially outward from the head to an outer end of the skirt, the valve disposed about the central post, the head of the valve longitudinally movable along the central post and relative to the outer end of the skirt, and the outer end of the skirt spaced from the cavity floor to fluidly separate the cavity of the housing into a first portion of the cavity between the skirt and the first housing port, and a second portion of the cavity between the skirt and the second housing port, the valve having a closed configuration in which the inner surface of the valve engages against the opening to resist fluid movement through the central post, and an open configuration in which the head is biased away from the opening to allow fluid movement through the central post.

[0007] In some examples, the present disclosure provides a needleless connector including a housing including a cap portion having a first housing port, a base portion having a second housing port, and a body portion extending from the cap portion to the body portion, wherein a valve seat is formed between the cap portion and the body portion, an inner surface of the housing forms a cavity between the base portion and the cap portion, and a central post extends into the cavity, the central post having a proximal end, a distal end, an opening, and an inner surface forming a lumen extending between the opening and the second housing port, wherein the central post is oriented with the proximal end at the base portion and the distal end between the valve seat and the first housing port; and a valve including a head and a skirt, the head having a top end, a bottom end, and an inner surface forming a passage through the head, wherein the central post extends into the passage, and the skirt extends radially outward from an inner end of the skirt at the head to an outer end of the skirt coupled to the valve seat; wherein the head is movable along the central post between a closed configuration and an open configuration, such that in the closed configuration the bottom end of the head is spaced a first distance from the proximal end of the central post, and the inner surface of the valve engages against the opening of the central post to resist fluid movement through the opening, and in the open configuration the bottom end of the head is spaced a second distance from the proximal end of the central post, the second distance being less than the first distance, and the inner surface of the valve is spaced from the opening of the central post to allow fluid flow through the opening.

[0008] In some embodiments of this disclosure, a pinless connector is provided, comprising a housing having a first housing port, a second housing port, an inner surface forming a cavity extending to the first housing port, and a central pillar extending into the cavity and toward the first housing port, the central pillar including an opening and an inner surface forming a lumen extending between the opening and the second housing port; and the disclosure also provides a valve including a head and a skirt, the head being disposed around the central pillar, and the skirt extending radially outward from the head to an outer end of the skirt, wherein the valve includes a closed configuration and an open configuration, in which the inner surface of the valve engages with the opening of the central pillar to prevent fluid movement therethrough, and in the open configuration, the head is displaced in a direction away from the first housing port such that the inner surface of the valve is spaced apart from the opening of the central pillar to allow fluid movement therethrough, and the skirt includes a skirt length from the head to the outer end of the skirt, the skirt length increasing as the valve moves from the closed configuration toward the open configuration.

[0009] Further features and advantages of this subject matter will be set forth in the description which follows, and some features and advantages will become apparent from the description or may be learned by practice of the subject matter. The advantages of this subject matter will be realized and obtained through the written description and embodiments, as well as the structures specifically pointed out in the accompanying drawings.

[0010] 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

[0011] The various features of illustrative embodiments of the present invention are described below with reference to the accompanying drawings. The illustrated embodiments are intended to illustrate, not limit, the present invention. The drawings include the following figures:

[0012] Figure 1 An IV kit connected to a patient is shown according to various aspects of this disclosure;

[0013] Figure 2 A cross-sectional view of a pinless connector according to various aspects of this disclosure is shown.

[0014] Figure 3 The various aspects shown in this disclosure are as follows Figure 2 Anatomical view of the needleless connector.

[0015] Figure 4 The various aspects shown in this disclosure are as follows Figure 2 A cross-sectional view of a pinless connector, with the valve in the open configuration.

[0016] Figure 5 The various aspects shown in this disclosure are as follows Figure 4Detail view of the needleless connector of

[0017] Figure 6 A perspective view of a valve for a needleless connector is shown in accordance with aspects of the present disclosure. Figure 2 Cross-sectional view of the needleless connector of

[0018] Figure 7 A cross-sectional view of another embodiment of a needleless connector is shown in accordance with aspects of the present disclosure, with the valve in a closed configuration.

[0019] Figure 8 A perspective view of a valve for a needleless connector is shown in accordance with aspects of the present disclosure. Figure 7 Cross-sectional view of the needleless connector of

[0020] Figure 9 A perspective view of a valve for a needleless connector is shown in accordance with aspects of the present disclosure.

[0021] Figure 10 A perspective view of another embodiment of a valve for a needleless connector is shown in accordance with aspects of the present disclosure.

[0022] Figure 11 A perspective view of another embodiment of a valve for a needleless connector is shown in accordance with aspects of the present disclosure. DETAILED DESCRIPTION

[0023] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the subject technology. It will be understood, however, that the subject technology can be practiced without these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.

[0024] Furthermore, although the specification describes particular embodiments, one of ordinary skill in the art will appreciate that the specification is illustrative only and is not intended to be limiting in any way. Additionally, it is contemplated that, despite disclosure of particular embodiments in the context of IV sets, these embodiments can be used in other fluid delivery systems. Furthermore, various applications of the embodiments disclosed herein, as well as modifications thereto, are possible and contemplated. Such modifications are encompassed by the following claims.

[0025] According to some embodiments, the present disclosure includes various features and advantages for providing a needleless connector that can prevent fluid from accumulating in areas of the needleless connector, such that the intended performance, operational efficiency, and safety of the needleless connector during use is maintained.

[0026] The needleless connector of the present disclosure can include a valve positioned within a cavity of the housing and movable relative to the housing. The valve includes a head and a skirt, where the skirt extends away from the head and is coupled to the housing of the needleless connector or to another structure. The skirt is coupled to the housing of the needleless connector or other structure to form a seal between the valve and the housing and define a first portion of the cavity and a second portion of the cavity, where the first and second portions of the cavity are fluidically isolated or separated from one another.

[0027] The first portion of the cavity is configured to receive fluid that can leak into the needleless connector during use, while the skirt can prevent the fluid from moving toward the second portion of the cavity. The first portion of the cavity is formed between any of the first housing port, the head of the valve, the skirt, and / or the housing of the needleless connector or other structure. The second portion of the cavity is formed between any of the head of the valve, the skirt, a distal end portion of the cavity or a bottom surface of the cavity, and / or the housing. The skirt is coupled to the housing at a location spaced apart from the bottom surface of the cavity such that the skirt is stretched or elongated when the head of the valve is moved in a direction away from the first housing port.

[0028] When a medical connector is inserted into the first housing port to engage and move the head of the valve, the valve can move in a direction away from the first housing port (i.e., from a closed configuration to an open configuration). As the valve moves from the closed configuration toward the open configuration, the skirt is stretched or elongated and the volume of the first portion of the cavity increases. Any fluid accumulated in the first portion of the cavity, such as fluid leaked from between the medical connector and the valve, is held in the first portion of the cavity to prevent the fluid from moving toward the second portion of the cavity.

[0029] When the valve moves from the open configuration toward the closed configuration, such as when the medical connector is withdrawn from the needleless connector, the valve moves toward the first housing port. The movement of the valve toward the first housing port causes the volume of the first portion of the cavity to decrease relative to the volume of the first portion when the valve is in the open configuration, such that any fluid accumulated in the first portion of the cavity is ejected or expelled from the needleless connector.

[0030] The needleless connector of the present disclosure can be used to transfer fluid through a fluid pathway coupled to the needleless connector. For example, the needleless connector can be coupled with a catheter to allow a medication to be injected into the catheter or to allow fluid to be withdrawn from the catheter. In Figure 1An example of a needleless connector 100 coupled with a catheter 20 is shown in FIG. 1, with a patient 22 and an intravenous (IV) set 24 coupled to the patient 22. The fluid pathway between the IV set 24 and the catheter 20 includes a y-branch 30 and the needleless connector 100. The y-branch 30 includes a first branch 26 and a second branch 28, each of which includes a needleless connector 100 coupled thereto. The IV set 24 is fluidly coupled to the catheter 30 by the needleless connector 100 coupled to the first branch 26, while the needleless connector 100 of the second branch 28 allows for injection or withdrawal of fluid with respect to the y-branch 30. The needleless connector 100 is configured with a female luer connector or similar needleless connector structure to allow for coupling of a medical connector to either of the first housing port or the second housing port of the needleless connector. For example, a syringe with a luer connector can be coupled to the needleless connector 100 to inject a medication through the needleless connector 100 or withdraw fluid from the needleless connector 100. In some aspects of the disclosure, the needleless connector can be used for high pressure injection through the needleless connector.

[0031] To allow or prevent movement of fluid through the needleless connector 100, the needleless connector includes a valve having a closed configuration and an open configuration. In the closed configuration, the valve prevents movement of fluid through the fluid pathway of the needleless connector 100, while in the open configuration, the valve allows movement of fluid through the fluid pathway of the needleless connector 100. In the Figure 1 In the example shown, the needleless connector 100 coupled to the first branch 26 has a valve in the open configuration, and the needleless connector 100 coupled to the second branch 28 has a valve in the closed configuration.

[0032] In the example shown, the needleless connector 100 coupled to the first branch 26 has a valve in the open configuration, and the needleless connector 100 coupled to the second branch 28 has a valve in the closed configuration. Figure 2 A cross-sectional view of the needleless connector 100 is shown in FIG. 2, with the valve in the closed configuration. The needleless connector 100 includes a housing 120 and a valve 200 that is movable with respect to the housing 120 as the valve 200 moves between the closed configuration and the open configuration.

[0033] The housing 120 includes a first housing port 122, a second housing port 124, and a cavity 126. The internal cavity 126 is formed by an inner surface 128 of the housing such that the cavity 126 extends through the first housing port 122 and into the needleless connector 100. A portion of the cavity 126 is also formed by a cavity floor 130, which can define an end portion of the cavity distal from the first housing port 122.

[0034] The needleless connector 100 also includes a central post 132 that extends into the cavity in a direction toward the first housing port 122. The central post 132 includes an opening 134 and a lumen 136 that forms a fluid pathway from the second housing port 124 to the opening 134.

[0035] The central post 132 defines a longitudinal axis Al that extends between the first housing port 122 and the second housing port 124. Thus, a fluid pathway through the needleless connector 100 extends along a path through the first housing port 122, an opening 134 of the central post, a lumen 136 of the central post, and the second housing port 124. A portion of the fluid pathway through the needleless connector 100 is also formed by the valve 200.

[0036] The valve 200 is positioned in the needleless connector 100 such that the valve is movable relative to the opening 134 of the central post between a closed configuration and an open configuration. The valve 200 includes a head 204 and a skirt 260. The head 204 has a top end 206 and a bottom end 208, with the bottom end opposite the top end 206. An inner surface 210 of the head forms a channel 212 that extends through the top end 206 of the head and the bottom end 208 of the head.

[0037] In some embodiments of the present disclosure, a portion of the channel 212 that extends through the top end 206 can be formed by a split septum 214. The split septum 214 is formed by the top end 206 of the valve having a slit 216 that extends through the top end 206 to the channel 212. When the valve 200 is in the closed configuration, the slit 216 is closed and the top end 206 of the valve forms a continuous surface. The continuous surface allows the top end 206 of the valve to be sterilized when the valve 200 is in the closed configuration.

[0038] The valve 200 also includes the skirt 260 that extends from the head 204 to the housing 120 to fluidically separate the cavity 126 of the housing into a first portion 140 of the cavity between the skirt 260 and the first housing port 122, and a second portion 142 of the cavity between the skirt 260 and the second housing port 124. In some examples of the present disclosure, the second portion 142 of the cavity is formed between the skirt 260 and the cavity floor 130.

[0039] To separate the cavity 126 of the housing into the first portion 140 of the cavity and the second portion 142 of the cavity, the skirt 260 includes an inner end 220 coupled to the head 204 and an outer end 222 distal to the head 204. As shown, the skirt 260 extends radially outward from the head 204 to the outer end 222 of the skirt. Figure 2 and Figure 3 As shown, the skirt 260 extends radially outward from the head 204 to the outer end 222 of the skirt.

[0040] The outer end 222 of the skirt is spaced apart from the cavity floor 130 to fluidly separate the cavity 126 of the housing into the first portion 140 of the cavity and the second portion 142 of the cavity. The outer end 222 of the skirt engages against the housing 120 at a location XI between the first housing port 122 and the cavity floor 130. The location XI at which the outer end 222 of the skirt engages against the housing 120 can be formed by a valve seat 146 configured to engage against the outer end 222 of the skirt. The valve seat at the location XI can prevent movement of the outer end 222 of the skirt when the head 204 of the valve is moved between the closed configuration and the open configuration.

[0041] While the outer end 222 of the skirt engages or couples to the housing 204 against the housing, the present disclosure contemplates embodiments in which the skirt 260 engages or couples to another portion of the needleless connector 100 against to fluidly separate the cavity 126 of the housing into the first portion 140 of the cavity and the second portion 142 of the cavity. For example, the outer end 222 of the skirt can engage or couple to a sleeve positioned in the cavity, a channel of the housing, and / or another structure of the needleless connector 100 against. Further, the present disclosure contemplates that the skirt 260 can be the same material as and integrally formed with the head 204 or the skirt 260 can be a different material and / or separately formed from the head 204.

[0042] In some embodiments of the present disclosure, the outer end 222 of the skirt includes a lip 224 configured to engage against the housing to hold the outer end 222 of the skirt together with the housing. In some cases, the lip 224 is positioned in the valve seat and the housing engages or compresses the lip 224 against.

[0043] The location XI at which the outer end 222 of the skirt engages against the housing 120 is spaced apart from the cavity floor such that the head 204 of the valve can move in a direction away from the first housing port. The location XI at which the outer end 222 of the skirt engages against the housing 120 is also configured such that when the valve 200 is in the open configuration, the head 204 is positioned between the outer end 222 of the skirt and the cavity floor 130. The position of the head 204 and the skirt 260 when the valve is in the open configuration maintains the separation between the first portion 140 of the cavity and the second portion 142 of the cavity, prevents any fluid accumulated in the first portion 140 of the cavity from moving into the second portion 142 of the cavity, and allows any fluid accumulated in the first portion 140 of the cavity to be ejected from the needleless connector 100 when the head is moved toward the closed configuration.

[0044] The position of the head 204 and skirt 260 can also be configured such that the skirt 200 is stretched or elongated as the valve 200 moves from the closed configuration toward the open configuration, and the skirt 200 returns to an unstretched or neutral configuration to move the head 204 of the valve from the open configuration toward the closed configuration when the valve is in the open configuration.

[0045] In some embodiments of the present disclosure, the position XI at which the outer end 222 of the skirt engages against the housing 120 is spaced apart from the cavity floor 130 by a distance Dl. The distance Dl is approximately greater than or equal to a distance D2 between the opening 134 of the central post and the top end 206 of the valve. In some embodiments, the distance Dl is approximately equal to or greater than a distance D3 between the position XI and the top end 206 of the valve. The relative distance, such as the distance Dl that is greater than or equal to D2, allows the head 204 to move to a position between the opening 134 and the cavity floor 130 and allows fluid to flow through the opening 134 when the valve is in the open configuration.

[0046] In some embodiments, the needleless connector 100 can have a housing formed from one or more parts that are joined together. For example, referring to Figure 3 The housing 120 can be formed from a cap portion 150, a base portion 152, and a body portion 154. The cap portion 150 forms a portion of the first housing port 122 and the cavity 126. The base portion 152 forms the second housing port 124 and the central post 132. The body portion 154 forms another portion of the cavity 126. The cap portion 150, the base portion 152, and the body portion 154 are assembled together such that the body portion 154 extends between the base portion 152 and the cap portion 150, and the central post 132 extends within the cavity from the base portion 154 toward the first housing port 122. Additionally, the valve seat 146 is formed by a channel or ridge that extends into the cap portion 150 such that the lip 222 of the valve is retained between the cap portion 150 and the body portion 154.

[0047] The cavity 126 of the housing 120 has a cross-sectional width that is transverse to the longitudinal axis Al. The cross-sectional width of the cavity can be uniform or can vary between the first housing port 122 and the cavity floor 130. In some embodiments of the present disclosure, the cavity 126 includes a first width Wl at the first housing port and a second width W2 at the position XI at which the outer end 222 of the skirt engages against the housing 120, where the second width W2 is greater than the first width Wl. The skirt 260 is oriented to extend from the position XI in a direction toward the first housing port 122 when the valve 200 is in the closed configuration, and the skirt 260 is oriented to extend from the position XI in a direction away from the first housing port 122 when the valve 200 is in the open configuration.

[0048] In some embodiments of this disclosure, the cross-sectional width of the housing 120 gradually narrows in the direction from position X1 toward the first housing port 122, such that the cross-sectional width of the housing 120 decreases in the direction from position X1 toward the first housing port 122. In some embodiments of this disclosure, the cross-sectional width of the housing 120 gradually narrows in the direction of the housing 120, thereby decreasing in the direction from position X1 toward the second housing port 124.

[0049] The cavity having a cross-sectional width of a second width W2 at position X1, greater than the first width W1, provides space for the skirt 260 to change direction or orientation as the valve moves between a closed configuration and an open configuration. In some examples of pinless connectors, the second width W2 allows the skirt 260 to change from extending in a direction toward the first housing port 122 when the valve is in the closed configuration to extending in a direction away from the first housing port 122 when the valve is in the open configuration.

[0050] When valve 200 is in the closed configuration, the inner surface 210 of the head engages with the opening 134 of the central support to block the lumen of the central support and prevent fluid movement through it. As the valve head 204 moves away from the first housing port 122, valve 200 moves toward the open configuration, and the inner surface 210 of the valve is spaced apart from the opening 134 of the central support to allow fluid movement through it. In some aspects of this disclosure, when valve 200 is in the closed configuration, the bottom end 208 of the head is spaced apart from the bottom surface 130 of the cavity or the proximal end of the central support by a fourth distance D4, and this fourth distance D4 decreases as the valve moves from the closed configuration toward the open configuration.

[0051] For example, in Figure 4 The diagram illustrates the valve's opening configuration, in which a medical connector 34 with a Luer fitting is inserted into a first housing port 122, causing the valve head 204 to shift or move along a central strut 132 and away from the first housing port 122. When the Luer fitting of the medical connector 34 is inserted into the first housing port 122, the end 35 of the Luer fitting engages against the top end 206 of the valve, forming a fluid passage between the medical connector 34 and the needleless connector 100. The fluid passage of the needleless connector 100 includes the opening 134 and lumen 136 of the central strut, and the second housing port 124.

[0052] To prevent fluid from flowing out of the fluid passage, valve 200 forms a primary seal between the inner surface 210 of the head and the outer surface of the central support 132, and skirt 260 forms an auxiliary seal between the head 204 and the inner surface 128 of the housing. Figure 5As shown, fluid accumulation or trapped in the first portion 140 of the cavity between the tip 35 of the luer fitting that engages against the top end 206 of the valve and the skirt 260 and the first housing port 122 can leak out of the fluid pathway when fluid is directed from the medical connector 34 into the fluid pathway of the needle-free connector 100 or from the fluid pathway of the needle-free connector 100 into the medical connector 34.

[0053] As the valve 200 moves from the open configuration toward the closed configuration, the fluid accumulated or trapped in the first portion 140 of the cavity can be ejected from the needle-free connector 100. As shown, Figure 6 As shown, the valve 200 can move from the open configuration toward the closed configuration when the medical connector 34 is withdrawn from the needle-free connector 100.

[0054] As the second portion 142 of the cavity is fluidically separated from the first portion 140 of the cavity, the second portion 142 of the cavity includes a first volume when the valve 200 is in the closed configuration and a second volume when the valve 200 is in the open configuration, where the second volume is less than the first volume. As the valve 200 moves from the closed configuration toward the open configuration and the volume of the second portion 142 of the cavity decreases, the pressure within the second portion 142 of the cavity increases. The increased pressure within the second portion 142 of the cavity can cause the valve 200 to move back to the closed configuration when the medical connector 34 is removed or withdrawn from the needle-free connector 100.

[0055] Further, in some embodiments of the present disclosure, the skirt 260 has a length LI from the inner end 220 to the outer end 222 when the valve is in the closed configuration. The needle-free connector 100 can be configured such that the skirt 260 has the length LI when the valve 200 is in the closed configuration or when the valve 200 is in a neutral or unbiased state. As the valve 200 moves from the closed configuration toward the open configuration, the skirt 260 is stretched or elongated to a length L2. The stretched or elongated skirt 260 can cause the valve 200 to move toward the closed configuration when the medical connector 34 is removed or withdrawn from the needle-free connector 100.

[0056] In another embodiment of the present disclosure, the outer end of the skirt can be coupled to a portion of the housing 120 between the bottom end of the head and the first housing port 122. Referring to Figure 7 and Figure 8 , an embodiment of a needle-free connector 101 having a valve 300 is shown. The valve 300 has a skirt 360 with an inner end 320 of the skirt extending from a head 304 of the valve to an outer end 322 of the skirt at the first housing port 122. The inner end 320 of the skirt extends from the bottom end 308 of the head and, in some embodiments, the inner end 320 of the skirt extends between the bottom end 308 and the top end 306 of the head. As shown, Figure 7As shown, when the valve 300 is in the closed configuration, the top end 306 of the head is aligned with the outer end 322 of the skirt.

[0057] In the closed configuration of valve 300, the top end 306 of the head, the outer end 322 of the skirt, and the portion of the housing forming the first housing port 122 are aligned with a common plane. This alignment of valve 300 and housing 120 provides a continuous or intact surface that can be easily sterilized and resists contamination.

[0058] like Figure 8 As shown, when the medical connector 34 engages with the valve head 304 and moves the valve head away from the first housing port 122, the valve 300 moves from a closed configuration toward an open configuration. As the valve 300 moves toward the open configuration, the skirt 360 stretches or elongates from length L3 to length L4, where length L4 is greater than length L3.

[0059] Valve 300 is also configured such that skirt 360 is located between a portion of the medical connector 34 inserted into the first housing port 122 and the inner surface of housing 120. In some embodiments of this disclosure, a portion of the skirt (e.g., outer end 322) is compressed between the medical connector 34 and housing 120. Engagement of the medical connector 34 against skirt 360 prevents displacement of the skirt as the valve moves toward the open configuration. When the medical connector 34 is removed or withdrawn from needleless connector 101, stretching or elongating skirt 360 can cause head 360 to move toward outer end 322 of the skirt, causing valve 200 to move toward the closed configuration.

[0060] As with valve 200 described elsewhere in this disclosure, fluid that may leak from the fluid passage between medical connector 34 and the top end 306 of the valve may accumulate or be trapped in a first portion 140 of the cavity between skirt 360 and first housing port 122. When valve 300 moves from an open configuration to a closed configuration, the fluid accumulated or trapped in the first portion 140 of the cavity is ejected from the needleless connector 101. When medical connector 34 is withdrawn from needleless connector 101, valve 200 can move from the open configuration to the closed configuration.

[0061] In some embodiments of this disclosure, the pinless connector includes a material that allows observation of its internal portions. For example, the material of the pinless connector may be configured to allow observation of the central support and / or the valve. In some embodiments of this disclosure, the material of the pinless connector allows observation of the valve in either its open or closed configuration, and / or of fluid moving along the fluid passage of the pinless connector. In some aspects of this disclosure, the material of the pinless connector (such as the housing and / or the valve) may be made of a translucent or transparent material.

[0062] ReferenceFigures 9-11 FIGS. 1-3 illustrate various embodiments of a valve for a needleless connector. Figure 9 FIG. 4 illustrates a perspective view of a valve 400 having a head 204 and a skirt 260 extending from the head. Figure 10 FIG. 5 illustrates a perspective view of a valve 500 having a head 204, a skirt 260 extending from the head 204, and a valve stem 421. For clarity and brevity, common features between the valves are indicated by like reference numerals. Figure 11 FIG. 4 illustrates a perspective view of a valve 400 having a head 204 and a skirt 260 extending from the head.

[0063] Each valve 200, 400, 500 includes a head 204 and a skirt 260. The head 204 has a top end 206 and a bottom end 208, with the bottom end opposite the top end 206. An inner surface of the head forms a channel extending through the top end 206 and the bottom end 208 of the head, and a portion of the channel extending through the top end 206 is formed by a split septum 214.

[0064] In some embodiments of the disclosure, the valve 200 has a skirt 260 including an inner end 220 coupled to the bottom end 208 of the head to form an outer surface of the head having a concave surface profile, at least as shown in Figure 2 Figure 3 Figure 9 The concave surface profile of the head 204 extends completely around a perimeter of the valve 200. When the valve 200 is in an open configuration, the skirt 260 can extend along the concave surface profile to form at least a portion of the first portion 140 of the cavity therebetween.

[0065] In some embodiments of the disclosure, the valve 400 has a skirt 260 including an inner end 220 coupled to the bottom end 208 of the head at a location radially inward relative to an outer surface of the head 204. Thus, a transition from the bottom end 208 of the head to the inner end 220 of the skirt forms an undercut or step. When the valve 400 is in an open configuration, the skirt 260 can extend over and along the undercut to form at least a portion of the first portion 140 of the cavity therebetween.

[0066] In some embodiments of the disclosure, the valve 500 has a skirt 260 including an inner end 220 coupled to the bottom end 208 of the head such that the skirt extends radially outward from the head 204 at an angle transverse relative to an outer surface of the head 204. When the valve 500 is in an open configuration, the skirt 260 can fold at a transition between the head 204 and the skirt 260 to form at least a portion of the first portion 140 of the cavity therebetween.

[0067] ​​Additionally, the valves 400, 500 can include a valve stem 421 having a first end 423 that extends from either of the head 204 and / or skirt 260 in a direction away from the top of the head end 206 of the head. The valve stem 421 also has a second end 425 such that the top end 206 of the head forms the distal-most end of the valve and the second end 425 of the valve stem forms the proximal-most end of the valve.

[0068] In embodiments of the valve having a valve stem 421, the skirt 260 is configured such that when the valve is in the closed configuration, the outer end 222 of the skirt is between the top end 206 of the head and the second end 425 of the valve stem.

[0069] When the valve is positioned in the needleless connector, the valve stem 421 extends from the head 204 toward the cavity floor 130. The valve stem 421 has a length L5 between the first end 423 and the second end 425 that is configured such that the second end 425 can engage against the cavity floor 130 or another portion of the needleless connector. The length of the valve stem can be approximately the same as the distance between the bottom end of the head and the cavity floor 130. In some cases, the length of the valve stem is greater than the distance between the bottom end of the head and the cavity floor 130 such that the valve stem provides a force against the head of the valve in the direction of the first cavity port. In some embodiments, the length of the valve stem is the same as the distance D4.

[0070] When the valve 400, 500 is moved from the closed configuration toward the open configuration, the valve stem 421 is elastically compressed. When the medical connector 34 is removed or withdrawn from the needleless connector, the valve stem 421 expands to direct the head 204 of the valve toward the first housing port 122, thereby directing the valve 400, 500 toward the closed configuration. In some embodiments of the present disclosure, the valve stem 421 is formed as a bellows between the first end 423 and the second end 425.

[0071] Features of the present disclosure provide a needleless connector having a valve with a head and a skirt that are configured to prevent the unintended accumulation of fluid that can leak into the needleless connector by capturing the fluid, impeding the movement of the fluid, and expelling the fluid from the needleless connector. Thus, features of the present disclosure provide a needleless connector with improved reliability performance and that provides for the full transmission of fluid through the needleless connector while also preventing the development of contamination in the needleless connector.

[0072] The subject technology is illustrated, for example, in accordance with various aspects described below. For convenience, various examples of aspects of the subject technology are described below. These are provided as examples only, and are not limiting of the subject technology.

[0073] A needleless connector comprising: a housing including a first housing port, a second housing port, a cavity extending through the first housing port to a cavity floor, and a central post extending into the cavity and toward the first housing port, the central post having an opening and an inner surface forming a lumen extending between the opening and the second housing port; and a valve including a head having an inner surface forming a passage through the head, and a skirt extending radially outward from the head to an outer end of the skirt, the valve disposed about the central post, the head of the valve longitudinally movable along the central post and relative to the outer end of the skirt, and the outer end of the skirt spaced from the cavity floor to fluidly separate the cavity of the housing into a first portion of the cavity between the skirt and the first housing port, and a second portion of the cavity between the skirt and the second housing port, the valve having a closed configuration in which the inner surface of the valve engages against the opening to block fluid movement through the central post, and an open configuration in which the head is biased away from the opening to allow fluid movement through the central post.

[0074] wherein the head of the valve includes a split septum forming a portion of the passage extending through a top end of the head.

[0075] wherein, in the closed configuration, the inner surface of the housing engages against the head and a portion of the passage through the top end of the head is blocked, and in the open configuration, the inner surface of the housing is spaced from the head and the central post extends through the portion of the passage through the top end of the head.

[0076] wherein the outer end of the skirt is between the opening of the central post and the cavity floor.

[0077] wherein the head of the valve moves relative to the outer end of the skirt when the valve moves from the closed configuration toward the open configuration.

[0078] wherein the outer end of the skirt includes a lip forming an outer perimeter of the skirt.

[0079] wherein the skirt includes a skirt length from an inner end of the skirt at the head to the outer end of the skirt, and the head includes a head length from a top end of the head to a bottom end of the head, and wherein the skirt length is less than the head length.

[0080] wherein, in the open configuration, the skirt extends outward from the head in a direction toward the top end of the head.

[0081] wherein in the closed configuration and the open configuration, the skirt extends outwardly from the head in a direction toward a top end of the head.

[0082] wherein the skirt includes a skirt length from an inner end of the skirt at the head to an outer end of the skirt, and the head includes a head length from a top end of the head to a bottom end of the head, and wherein the skirt length is greater than the head length.

[0083] wherein in the closed configuration, the first portion of the cavity includes a first volume, and in the open configuration, the first portion of the cavity includes a second volume, and wherein the second volume is greater than the first volume.

[0084] wherein in the closed configuration, the second portion of the cavity includes a first volume, and in the open configuration, the second portion of the cavity includes a second volume, and wherein the second volume is greater than the first volume.

[0085] wherein the valve includes a valve stem extending from a bottom end of the head in a direction away from a top end of the head, and wherein the skirt extends around the valve stem.

[0086] wherein the valve stem includes a first end coupled to the head and a second end, and an outer end of the skirt is longitudinally between the head and the second end of the valve stem.

[0087] wherein the valve stem is formed as an elastically compressible bellows between the first end and the second end of the valve stem.

[0088] wherein the opening extends radially from the lumen in a direction transverse to a longitudinal axis of the central strut.

[0089] A needleless connector comprising: a housing comprising a cap portion having a first housing port, a base portion having a second housing port, and a body portion extending from the cap portion to the body portion, wherein a valve seat is formed between the cap portion and the body portion, an inner surface of the housing forms a cavity between the base portion and the cap portion, and a center post extends into the cavity, the center post having a proximal end, a distal end, an opening, and an inner surface forming a lumen extending between the opening and the second housing port, wherein the center post is oriented with the proximal end at the base portion and the distal end between the valve seat and the first housing port; and a valve comprising a head and a skirt, the head having a top end, a bottom end, and an inner surface forming a passageway through the head, wherein the center post extends into the passageway, and the skirt extends radially outward from an inner end of the skirt at the head to an outer end of the skirt coupled to the valve seat; wherein the head is movable along the center post between a closed configuration and an open configuration, such that in the closed configuration the bottom end of the head is spaced apart from the proximal end of the center post by a first distance, and the inner surface of the valve is engaged against the opening of the center post to block fluid movement through the opening, in the open configuration the bottom end of the head is spaced apart from the proximal end of the center post by a second distance that is less than the first distance, and the inner surface of the valve is spaced apart from the opening of the center post to allow fluid flow through the opening.

[0090] wherein the valve is positioned with the center post extending into the passageway such that a first distance from the bottom end of the head to the distal end of the center post is less than a second distance from the bottom end of the head to the proximal end of the center post.

[0091] wherein in the closed configuration the skirt extends from the valve seat in a direction toward the first housing port, and in the open configuration the skirt extends from the valve seat in a direction away from the first housing port.

[0092] wherein the cavity has a first width at the first housing port and a second width at the valve seat, and wherein the second width is greater than the first width.

[0093] wherein the width of the cavity decreases in a direction from the valve seat toward the first housing port and in a direction from the valve seat away from the first housing port.

[0094] A needleless connector comprising: a housing comprising a first housing port, a second housing port, an inner surface forming a cavity extending to the first housing port, and a central post extending into the cavity and toward the first housing port, the central post comprising an opening and an inner surface forming a lumen extending between the opening and the second housing port; and a valve comprising a head and a skirt, the head disposed about the central post and the skirt extending radially outward from the head to an outer end of the skirt, wherein the valve comprises a closed configuration in which the inner surface of the valve is engaged against the opening of the central post to resist movement of fluid therethrough, and an open configuration in which the head is displaced in a direction away from the first housing port such that the inner surface of the valve is spaced apart from the opening of the central post to allow movement of fluid therethrough, and the skirt comprises a skirt length from the head to the outer end of the skirt that increases as the valve is moved from the closed configuration toward the open configuration.

[0095] wherein the head of the valve moves relative to the outer end of the skirt as the valve is moved from the closed configuration toward the open configuration.

[0096] wherein in the closed configuration the skirt extends from the head in a direction away from a top end of the head, and in the open configuration the skirt extends from the head in a direction toward the top end of the head.

[0097] wherein the valve comprises a valve stem extending about the central post, and the skirt extends about the valve stem.

[0098] In some embodiments, any of the clauses herein can rely on any of the independent clauses or any of the dependent clauses. In one aspect, any of the clauses (e.g., dependent or independent) can be combined with any other one or more clauses (e.g., dependent or independent). In one aspect, a claim can include some or all of the language recited in a clause, sentence, phrase, or paragraph (e.g., steps, operations, means, or elements). In one aspect, a claim can include some or all of the language recited in one or more clauses, sentences, phrases, or paragraphs. In one aspect, some of the language in each of the clauses, sentences, phrases, or paragraphs can be removed. In one aspect, additional language or elements can be added to the clauses, sentences, phrases, or paragraphs. In one aspect, the subject technology can be practiced without utilizing some of the components, elements, functions, or operations recited in the specification. In one aspect, the subject technology can be practiced with additional components, elements, functions, or operations.

[0099] The present disclosure is presented to enable a person skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology and the subject technology is not limited to these examples. Numerous modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein can be applied to other aspects.

[0100] Unless specifically stated otherwise, a reference to an element in the singular does not preclude the occurrence of additional, identical elements. Unless specifically stated otherwise, the term "some" refers to one or more. The term "positive" pronoun (e.g., his) includes female and neutral gender (e.g., her and its), and vice versa. The use of headings and subheadings (if any) is for convenience only and does not limit the disclosure.

[0101] 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 can be considered equivalents in at least some aspects.

[0102] Phrases such as "aspect" do not imply that a particular aspect is essential to the subject technology, or that the aspect applies to all configurations of the subject technology. Disclosure in relation to one aspect can apply to all configurations or one or more configurations. An aspect can provide one or more examples. Phrases such as "one aspect" can refer to one or more aspects, and vice versa. Phrases such as "embodiment" do not imply that a particular embodiment is essential to the subject technology, or that the embodiment applies to all configurations of the subject technology. Disclosure in relation to one embodiment can apply to all embodiments or one or more embodiments. An embodiment can provide one or more examples. Phrases such as "one embodiment" can refer to one or more embodiments, and vice versa. Phrases such as "configuration" do not imply that a particular configuration is essential to the subject technology, or that the configuration applies to all configurations of the subject technology. Disclosure in relation to one configuration can apply to all configurations or one or more configurations. A configuration can provide one or more examples. Phrases such as "configuration" can refer to one or more configurations, and vice versa.

[0103] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

[0104] In one aspect, the term "coupled" and the like can mean directly coupled. In another aspect, the term "coupled" and the like can mean indirectly coupled.

[0105] Terms such as "top," "bottom," "front," "back," and the like as used in the disclosure should be understood in terms of any arbitrary frame of reference rather than in terms of an ordinary gravitational reference frame. Thus, top surfaces, bottom surfaces, front surfaces, and back surfaces can extend upward, downward, diagonally, or horizontally in a gravitational reference frame.

[0106] Various items can be arranged differently (e.g., in a different order, or partitioned differently) without departing from the scope of the subject technology. All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known are expressly incorporated by reference and are intended to be encompassed by the claims. Furthermore, no inference is to be drawn from the conception of one claimed aspect (for example, an independently claimed aspect or a dependent claim) in terms of its components' cooperation, progression, or combination with those of a further claimed aspect even though described components of the claimed aspects can in some

[0107] The title, background, brief summary, abstract, and drawings of the disclosure are hereby incorporated into this disclosure and provided as illustrative examples of the disclosure and are not limiting in description. The present application is filed based on the understanding that they will not be used to limit the scope or meaning of the claims. Furthermore, in the DETAILED DESCRIPTION, it can be seen that the description provides illustrative examples and, in the interest of simplifying the disclosure, various features are combined in various embodiments. The disclosed methods 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 reflected in the following claims, inventive subject matter lies in less than all features of a single disclosed construction or operation. The claims hereinafter are thus incorporated into the detailed description, each claim independently standing as a separate claimed subject matter.

[0108] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language claims, wherein reference to an aspect, for example, is intended to reference any one aspect or combination of aspects claimed in any combination. Thus, claims can be regarded as including any subset of features that are not expressly written out in the claims. Further, no reference is necessary in the alternative.

Claims

1. A needleless connector comprising: It includes: a housing including a first housing port, a second housing port, a cavity extending through the first housing port to a cavity floor, and a central post extending into the cavity and toward the first housing port, the central post having an opening and an inner surface, the inner surface forming a lumen extending between the opening and the second housing port; and and a valve including a head and a skirt, the head having an inner surface forming a passage through the head, and the skirt extending radially outward from the head to an outer end of the skirt, the valve disposed about the central post, the head of the valve longitudinally movable along the central post and relative to the outer end of the skirt, and the outer end of the skirt spaced from the cavity floor to fluidly separate the cavity of the housing into a first portion of the cavity between the skirt and the first housing port, and a second portion of the cavity between the skirt and the second housing port, the valve having a closed configuration in which the inner surface of the valve engages against the opening to resist fluid movement through the central post, and an open configuration in which the head is biased away from the opening to allow fluid movement through the central post.

2. The needleless connector of claim 1, wherein, The head of the valve includes a split septum forming a portion of the passage extending through a top end of the head.

3. The needleless connector of claim 1, wherein, In the closed configuration, the inner surface of the housing engages against the head, and a portion of the passage through the top end of the head is blocked, and in the open configuration, the inner surface of the housing is spaced from the head, and the central post extends through the portion of the passage through the top end of the head.

4. The needleless connector of claim 1, wherein, The outer end of the skirt is between the opening of the central post and the cavity floor.

5. The needleless connector of claim 1, wherein, The head of the valve moves relative to the outer end of the skirt when the valve moves from the closed configuration toward the open configuration.

6. The needle-free connector of claim 1, wherein, In the closed configuration, the skirt extends outward from the head in a direction away from the top end of the head, in the open configuration, the skirt extends outward from the head in a direction toward the top end of the head.

7. The needle-free connector of claim 1, wherein, In the closed configuration and the open configuration, the skirt extends outward from the head in a direction toward the top end of the head.

8. The needle-free connector of claim 1, wherein, In the closed configuration, the second portion of the cavity includes a first volume, and in the open configuration, the second portion of the cavity includes a second volume, and wherein the second volume is greater than the first volume.

9. The needleless connector of claim 1, wherein, The valve includes a valve stem extending from a bottom end of the head in a direction away from the top end of the head, and wherein the skirt extends around the valve stem.

10. The needleless connector of claim 9, wherein, The valve stem includes a first end coupled to the head, and the outer end of the skirt is longitudinally between the head and a second end of the valve stem.

11. The needleless connector of claim 9, wherein, The valve stem is formed as an elastically compressible bellows between the first end and the second end of the valve stem.

12. A needleless connector comprising: It includes: a housing including a cap portion having a first housing port, a base portion having a second housing port, and a body portion extending from the cap portion to the body portion, wherein a valve seat is formed between the cap portion and the body portion, an inner surface of the housing forms a cavity between the base portion and the cap portion, and a center post extends into the cavity, the center post having a proximal end, a distal end, an opening, and an inner surface forming a lumen extending between the opening and the second housing port, wherein the center post is oriented with the proximal end at the base portion and the distal end between the valve seat and the first housing port; and a valve including a head and a skirt, the head having a top end, a bottom end, and an inner surface forming a passage through the head, wherein the center post extends into the passage, and the skirt extends radially outward from an inner end of the skirt at the head to an outer end of the skirt coupled to the valve seat; wherein the head is movable along the center post between a closed configuration and an open configuration, such that in the closed configuration the bottom end of the head is spaced apart from the proximal end of the center post by a first distance and the inner surface of the valve is engaged against the opening of the center post to block fluid movement through the opening, and in the open configuration the bottom end of the head is spaced apart from the proximal end of the center post by a second distance that is less than the first distance and the inner surface of the valve is spaced apart from the opening of the center post to allow fluid flow through the opening.

13. The needleless connector of claim 12, wherein, the valve is positioned with the center post extending into the passage such that a first distance from the bottom end of the head to the distal end of the center post is less than a second distance from the bottom end of the head to the proximal end of the center post.

14. The needleless connector of claim 12, wherein, in the closed configuration the skirt extends from the valve seat in a direction toward the first housing port, and in the open configuration the skirt extends from the valve seat in a direction away from the first housing port.

15. The needleless connector of claim 12, wherein, the cavity has a first width at the first housing port and a second width at the valve seat, and wherein the second width is greater than the first width.

16. The needleless connector of claim 12, wherein, the width of the cavity decreases in a direction from the valve seat toward the first housing port and in a direction from the valve seat away from the first housing port.

17. A needleless connector comprising: it includes: a housing including a first housing port, a second housing port, an inner surface forming a cavity extending to the first housing port, and a center post extending into the cavity and toward the first housing port, the center post including an opening and an inner surface forming a lumen extending between the opening and the second housing port; and A valve comprising a head portion disposed about the central post and a skirt portion extending radially outward from the head portion to an outer end of the skirt portion, wherein the valve comprises a closed configuration in which an inner surface of the valve engages against an opening of the central post to prevent fluid movement therethrough and an open configuration in which the head portion is displaced in a direction away from the first housing port such that the inner surface of the valve is spaced apart from the opening of the central post to allow fluid movement therethrough, and the skirt portion comprises a skirt length from the head portion to the outer end of the skirt portion that increases as the valve moves from the closed configuration toward the open configuration.

18. The needleless connector of claim 17, wherein, The head portion of the valve moves relative to the outer end of the skirt portion as the valve moves from the closed configuration toward the open configuration.

19. The needleless connector of claim 17, wherein, In the closed configuration, the skirt portion extends from the head portion in a direction away from a top end of the head portion, and in the open configuration, the skirt portion extends from the head portion in a direction toward the top end of the head portion.

20. The needleless connector of claim 17 wherein, The valve comprises a valve stem extending about the central post, and the skirt portion extends about the valve stem.

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