Needleless connector

Abstract

A needleless connector is disclosed 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 a needleless connector having a valve configured to prevent fluid from accidentally accumulating in the needleless connector. Background Art

[0002] Needleless connectors, including neutral displacement needleless connectors, provide a solution for providing medical fluids to patients in a safe, efficient and effective manner. Needleless connectors allow fluids to be transferred through the connector, such as between a medical fluid supply source and a catheter line, without the need for a needle to pierce the connector septum. In some cases, needleless connectors include a large internal volume, which may result in a large amount of residual fluid within the needleless connector after use of the needleless connector. Among other things, a large amount of residual fluid that was originally intended to be administered to the patient is not actually administered to the patient, and may result in contamination of the residual fluid and the needleless connector.

[0003] The needleless connector may include a valve positioned within the housing such that when the medical connector is inserted into the needleless connector, the valve moves to an open configuration and engagement of the medical connector against the valve forms a fluid path between the fluid passageways of the medical connector and the needleless connector.

[0004] In some cases, fluid may leak from the fluid pathway in or around the area where the medical connector abuts the valve, resulting in unintended accumulation of fluid in the needleless connector. The accumulation of fluid in the needleless connector may degrade the performance of the needleless connector, including causing the valve of the needleless connector to fail to compress or return to a neutral position as expected. In addition, the accumulated fluid may result in incomplete fluid or less than expected fluid flow through the needleless connector. In some cases, the accumulated fluid may result in the formation of biofilm in the needleless connector, which may expose the patient to catheter-related infections. Summary of the invention

[0005] According to at least some embodiments disclosed herein, it is recognized that unexpected accumulation of fluid in a needleless connector may reduce the performance of the needleless connector or cause it to malfunction. In addition, the present disclosure contemplates that unexpected accumulation of fluid in a needleless connector may be caused by leakage of a fluid pathway formed between a valve of the needleless connector and a medical connector engaged against the valve. In addition, the present disclosure contemplates features that allow viewing of the interior of the needleless connector, which may aid in viewing and identifying situations that may lead to unexpected performance of the needleless connector.

[0006] Various aspects of the present disclosure provide a needleless connector, which includes: a housing having a first housing port, a second housing port, a cavity extending through the first housing port to a cavity bottom surface, and a central pillar extending into the cavity and toward the first housing port, the central pillar having an opening and an inner surface, the inner surface forming a lumen extending between the opening and the second housing port; and the present disclosure also provides a valve, the valve including a head and a skirt, the head having an inner surface forming a channel through the head, and the skirt extending radially outward from the head to an outer end of the skirt, the valve being arranged around the central pillar, the head of the valve being able to move longitudinally along the central pillar and relative to the outer end of the skirt, and the outer end of the skirt being spaced from the cavity bottom surface to fluidically divide 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 and an open configuration, in which the inner surface of the valve engages against the opening to prevent fluid from moving through the central pillar, and in which the head is biased away from the opening to allow fluid to move through the central pillar.

[0007] In some examples, the present disclosure provides a needleless connector comprising a shell, the shell comprising a cover portion having a first shell port, a base portion having a second shell port, and a main body portion extending from the cover portion to the main body portion, wherein a valve seat is formed between the cover portion and the main body portion, an inner surface of the shell forms a cavity between the base portion and the cover portion, and a central pillar extends into the cavity, the central pillar having a proximal end, a distal end, an opening, and an inner surface, the inner surface forming a lumen extending between the opening and the second shell port, wherein the central pillar is oriented with the proximal end at the base portion and the distal end between the valve seat and the first shell port; and the present disclosure also provides a valve, the valve comprising a head and a skirt, the head having a top The valve body comprises 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 the inner end of the skirt at the head to the outer end of the skirt connected 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 a first distance from the proximal end of the center post and the inner surface of the valve engages against the opening of the center post to prevent fluid from moving 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 center post, the second distance being less than the first distance, and the inner surface of the valve is spaced from the opening of the center post to allow fluid to flow through the opening.

[0008] In some examples of the present disclosure, a needleless connector is provided, which includes a shell having a first shell port, a second shell port, an inner surface forming a cavity extending to the first shell port, and a central pillar extending into the cavity and toward the first shell port, the central pillar including an opening and an inner surface, the inner surface forming a lumen extending between the opening and the second shell port; and the present disclosure also provides a valve, the valve including a head and a skirt, the head being arranged around the central pillar, and the skirt extending radially outward from the head to the outer end of the skirt, wherein the valve includes a closed structure and an open structure, in which the inner surface of the valve is engaged against the opening of the central pillar to prevent fluid from moving therethrough, and in the open structure, the head is displaced in a direction away from the first shell port so that the inner surface of the valve is spaced apart from the opening of the central pillar to allow fluid to move therethrough, and the skirt includes a skirt length from the head to the outer end of the skirt, and the skirt length increases when the valve moves from the closed structure toward the open structure.

[0009] The other characteristics and advantages of the subject technology will be described in the following description, and some characteristics and advantages will become clear from the description, or can be understood by practicing the subject technology. The advantages of the subject technology will be realized and obtained through the structures specifically pointed out in the written description and embodiments and the accompanying drawings.

[0010] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] 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, but not limit, the present invention. The accompanying drawings include the following figures:

[0012] Figure 1 An IV set coupled to a patient is shown in accordance with aspects of the present disclosure;

[0013] Figure 2 A cross-sectional view of a needleless connector according to aspects of the present disclosure is shown.

[0014] Figure 3 The present invention shows various aspects of the present invention. Figure 2 Exploded cross-sectional view of the needleless connector.

[0015] Figure 4 The present invention shows various aspects of the present disclosure. Figure 2 A cross-sectional view of a needleless connector with the valve in an open configuration.

[0016] Figure 5 The present invention shows various aspects of the present invention. Figure 4Detailed view of the pinless connector.

[0017] Figure 6 The present invention shows various aspects of the present invention. Figure 2 A cross-sectional view of a needleless connector with the valve between an open configuration and a closed configuration.

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

[0019] Figure 8 The present invention shows various aspects of the present invention. Figure 7 A cross-sectional view of a needleless connector with the valve in an open configuration.

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

[0021] Fig.10 A perspective view of another embodiment of a valve for a needleless connector according to aspects of the present disclosure is shown.

[0022] Fig.11 A perspective view of another embodiment of a valve for a needleless connector according to aspects of the present disclosure is shown. DETAILED DESCRIPTION

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

[0024] Furthermore, although the present specification sets forth specific details of various embodiments, it should be understood that the description is illustrative only and should not be construed as limiting in any way. Furthermore, it is contemplated that although specific embodiments of the present disclosure may be disclosed or illustrated in the context of an IV set, these embodiments may be used in other fluid delivery systems. Furthermore, various applications of such embodiments and modifications thereof that may occur to a person skilled in the art are also included in the general concepts described herein.

[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 the area of ​​the needleless connector so that the expected performance, operating efficiency, and safety of the needleless connector during use are maintained.

[0026] The needleless connector of the present disclosure may include a valve positioned within a cavity of a housing and movable relative to the housing. The valve includes a head and a skirt, wherein 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 or other structure of the needleless connector 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, wherein the first portion and the second portion of the cavity are fluidly isolated or separated from each other.

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

[0028] When the 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). When 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 leaking from between the medical connector and the valve) is retained 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, causing any fluid accumulated in the first portion of the cavity to be 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 to a catheter to allow injection of a drug into the catheter or to allow fluid to be extracted from the catheter. Figure 12 shows an example of a needleless connector 100 coupled to a catheter 20, wherein there is a patient 22 and an intravenous (IV) kit 24 coupled to the patient 22. The fluid passage between the IV kit 24 and the catheter 20 includes a y-shaped tee 30 and a needleless connector 100. The y-shaped tee 30 includes a first branch 26 and a second branch 28, each of which includes a needleless connector 100 coupled thereto. The IV kit 24 is fluidically 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 injection or extraction of fluid relative to the y-shaped tee 30. The needleless connector 100 is configured with a female Luer connector or a similar needleless connector structure to allow a medical connector to be coupled 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 drug through the needleless connector 100 or to extract a fluid from the needleless connector 100. In some aspects of the present disclosure, the needleless connector may be used to perform high pressure injections through the needleless connector.

[0031] In order to allow or prevent fluid from moving 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 fluid from moving through the fluid path of the needleless connector 100, while in the open configuration, the valve allows fluid to move through the fluid path of the needleless connector 100. Figure 1 In the example shown, the needleless connector 100 coupled to the first branch 26 has the valve in an open configuration, and the needleless connector 100 coupled to the second branch 28 has the valve in a closed configuration.

[0032] exist Figure 2 The needleless connector 100 is shown in a cross-sectional view of the needleless connector 100 with the valve in a closed configuration. The needleless connector 100 includes a housing 120 and a valve 200 that can move relative to the housing 120 when the valve 200 moves between a closed configuration and an open configuration.

[0033] The housing 120 includes a first housing port 122, a second housing port 124, and a cavity 126. The interior cavity 126 is formed by an interior 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 may define an end portion of the cavity away 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 passage from the second housing port 124 to the opening 134.

[0035] The center post 132 defines a longitudinal axis A1 extending 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, the opening 134 of the center post, the lumen 136 of the center 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 so that the valve can move between a closed configuration and an open configuration relative to the opening 134 of the center pillar. The valve 200 includes a head 204 and a skirt 260. The head 204 has a top end 206 and a bottom end 208, wherein the bottom end is opposite the top end 206. The inner surface 210 of the head forms a channel 212 extending through the top end 206 of the head and the bottom end 208 of the head.

[0037] In some embodiments of the present disclosure, the portion of the channel 212 extending through the top end 206 can be formed by a split diaphragm 214. The split diaphragm 214 is formed by the top end 206 of the valve having a slit 216 extending 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 further includes a skirt 260 extending from the head 204 to the housing 120 to fluidly separate the housing cavity 126 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 bottom surface 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. 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 bottom surface 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 position X1 between the first housing port 122 and the cavity bottom surface 130. The position X1 where the outer end 222 engages against the housing 120 may be formed by a valve seat 146 configured to engage against the outer end 222 of the skirt. The valve seat at the position X1 may prevent movement of the outer end 222 of the skirt when the head 204 of the valve moves between the closed configuration and the open configuration.

[0041] Although the outer end 222 of the skirt is engaged against or coupled to the housing 204, the present disclosure contemplates embodiments in which the skirt 260 is engaged against or coupled to another portion of the needleless connector 100 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 be engaged against or coupled to a sleeve positioned in the cavity, a channel of the housing, and / or another structure of the needleless connector 100. Furthermore, the present disclosure contemplates that the skirt 260 can be the same material as the head 204 or be integrally formed therewith, or the skirt 260 can be a different material than the head 204 and / or be formed separately therefrom.

[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 located in the valve seat, and the housing engages or compresses the lip 224 against the lip.

[0043] The position X1 at which the outer end 222 of the skirt abuts against the housing 120 is spaced from the cavity bottom surface so that the head 204 of the valve can move in a direction away from the first housing port. The position X1 at which the outer end 222 of the skirt abuts against the housing 120 is also configured so that when the valve 200 is in the open configuration, the head 204 is located between the outer end 222 of the skirt and the cavity bottom surface 130. When the valve is in the open configuration, the position of the head 204 and the skirt 260 maintains the separation between the first portion 140 of the cavity and the second portion 142 of the cavity, preventing any fluid accumulated in the first portion 140 of the cavity from moving into the second portion 142 of the cavity, and when the head moves toward the closed configuration, any fluid accumulated in the first portion 140 of the cavity is ejected from the needleless connector 100.

[0044] When the valve is in the open configuration, the position of the head 204 and the skirt 260 can also be configured so that the skirt 200 is stretched or elongated when 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.

[0045] In some embodiments of the present disclosure, the outer end 222 of the skirt is spaced apart from the cavity bottom surface 130 by a distance D1 at a position X1 where it engages the housing 120. The distance D1 is approximately greater than or equal to the distance D2 between the opening 134 of the center post and the top end 206 of the valve. In some embodiments, the distance D1 is approximately equal to or greater than the distance D3 between the position X1 and the top end 206 of the valve. When the valve is in an open configuration, the relative distance (e.g., the distance D1 being greater than or equal to D2) allows the head 204 to move to a position between the opening 134 and the cavity bottom surface 130 and allows fluid to flow through the opening 134.

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

[0047] The cavity 126 of the housing 120 has a cross-sectional width transverse to the longitudinal axis A1. The cross-sectional width of the cavity may be uniform or may vary between the first housing port 122 and the cavity bottom surface 130. In some embodiments of the present disclosure, the cavity 126 includes a first width W1 at the first housing port and a second width W2 at a position X1 where the outer end 222 of the skirt engages the housing 120, wherein the second width W2 is greater than the first width W1. When the valve 200 is in the closed configuration, the skirt 260 is oriented to extend from the position X1 in a direction toward the first housing port 122, and when the valve 200 is in the open configuration, the skirt 260 is oriented to extend from the position X1 in a direction away from the first housing port 122.

[0048] In some embodiments of the present disclosure, the cross-sectional width of the housing 120 gradually narrows in the direction from the position X1 toward the first housing port 122, so that the cross-sectional width of the housing 120 decreases in the direction from the position X1 toward the first housing port 122. In some embodiments of the present disclosure, the cross-sectional width of the housing 120 gradually narrows in the direction of the housing 120, so as to decrease in the direction from the position X1 toward the second housing port 124.

[0049] The cross-sectional width of the cavity having a second width W2 greater than the first width W1 at position X1 can provide space for the skirt 260 to transition or change direction when the valve moves between the closed configuration and the open configuration. In some examples of needleless connectors, the second width W2 allows the skirt 260 to transition 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 the valve 200 is in the closed configuration, the inner surface 210 of the head engages against the opening 134 of the center post to block the lumen of the center post and prevent fluid from moving therethrough. When the head 204 of the valve moves in a direction away from the first housing port 122, the valve 200 moves toward the open configuration, and the inner surface 210 of the valve is spaced apart from the opening 134 of the center post to allow fluid to move therethrough. In some aspects of the present disclosure, when the valve 200 is in the closed configuration, the bottom end 208 of the head is spaced apart from the cavity bottom surface 130 or the proximal end of the center post by a fourth distance D4, and the fourth distance D4 decreases as the valve moves from the closed configuration toward the open configuration.

[0051] For example, in Figure 4 100, wherein a medical connector 34 having a luer fitting is inserted into the first housing port 122 to displace or move the head 204 of the valve along the center post 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 tip 35 of the luer fitting engages against the top end 206 of the valve and forms a fluid pathway between the medical connector 34 and the needleless connector 100. The fluid pathway of the needleless connector 100 includes the opening 134 and lumen 136 of the center post, and the second housing port 124.

[0052] To prevent fluid from flowing out of the fluid passage, the valve 200 forms a primary seal between the inner surface 210 of the head and the outer surface of the center post 132, and the skirt 260 forms a secondary seal between the head 204 and the inner surface 128 of the housing. Figure 5As shown, when fluid is directed from the medical connector 34 to the fluid pathway of the needleless connector 100, or from the fluid pathway of the needleless connector 100 to the medical connector 34, fluid that may leak out of the fluid pathway between the end 35 of the Luer fitting that engages the top end 206 of the valve accumulates or is trapped in the first portion 140 of the cavity between the skirt 260 and the first housing port 122.

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

[0054] Because the second portion 142 of the cavity is fluidly 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 includes a second volume when the valve 200 is in the open configuration, wherein 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. When the medical connector 34 is removed or withdrawn from the needleless connector 100, the increased pressure within the second portion 142 of the cavity can cause the valve 200 to move back to the closed configuration.

[0055] In addition, in some embodiments of the present disclosure, when the valve is in the closed configuration, the skirt 260 has a length L1 from the inner end 220 to the outer end 222. The needleless connector 100 can be configured such that when the valve 200 is in the closed configuration or when the valve 200 is in a neutral or unbiased state, the skirt 260 has a length L1. As the valve 200 moves from the closed configuration toward the open configuration, the skirt 260 is stretched or elongated to a length L2. When the medical connector 34 is removed or withdrawn from the needleless connector 100, the stretched or elongated skirt 260 can cause the valve 200 to move toward the closed configuration.

[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. Figure 7 and Figure 8 , shows an embodiment of a needleless connector 101 having a valve 300. The valve 300 has a skirt 360, the inner end 320 of the skirt extending from the head 304 of the valve to the 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 from between the bottom end 308 and the top end 306 of the head. 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 the 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. The alignment of the valve 300 and the housing 120 provides a continuous or complete surface that can be easily sterilized and can resist contamination.

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

[0059] The valve 300 is also configured such that the skirt 360 is located between a portion of the medical connector 34 that is inserted into the first housing port 122 and the inner surface of the housing 120. In some examples of the present disclosure, a portion of the skirt (e.g., the outer end 322) is compressed between the medical connector 34 and the housing 120. The engagement of the medical connector 34 against the skirt 360 can prevent displacement of the skirt when the valve moves toward the open configuration. When the medical connector 34 is removed or withdrawn from the needleless connector 101, the stretched or elongated skirt 360 can cause the head 360 to move toward the outer end 322 of the skirt, so that the valve 200 moves toward the closed configuration.

[0060] As with the valve 200 described in other parts of the present disclosure, fluid that may leak from the fluid pathway between the medical connector 34 and the top end 306 of the valve accumulates or is trapped in the first portion 140 of the cavity between the skirt 360 and the first housing port 122. When the valve 300 is moved from the open configuration to the closed configuration, the fluid accumulated or trapped in the first portion 140 of the cavity is ejected from the needleless connector 101. The valve 200 may be moved from the open configuration to the closed configuration when the medical connector 34 is withdrawn from the needleless connector 101.

[0061] In some embodiments of the present disclosure, the needleless connector includes a material that allows observation of its internal portions. For example, the material of the needleless connector can be configured to allow observation of the center pillar and / or valve. In some embodiments of the present disclosure, the material of the needleless connector allows observation of the valve in any of the open and closed configurations of the valve, and / or the fluid moving along the fluid path of the needleless connector. In some aspects of the present disclosure, the material of the needleless connector (such as the housing and / or the valve) can be composed of a translucent or transparent material.

[0062] Reference Figure 9-11 , showing multiple embodiments of valves for needleless connectors. Fig. 9 A perspective view of a valve 200 is shown having a head 204 and a skirt 260 extending from the head. Fig.10 and Fig.11 Each shows a perspective view of an embodiment of a valve 400, 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.

[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, wherein the bottom end is opposite the top end 206. The inner surface of the head forms a passage extending through the top end 206 and the bottom end 208 of the head, and a portion of the passage extending through the top end 206 is formed by the split diaphragm 214.

[0064] In some embodiments of the present disclosure, the valve 200 has a skirt 260 including an inner end 220 that is 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 Figure 2 , Figure 3 and Fig. 9 The concave surface profile of the head 204 extends completely around the perimeter of the valve 200. When the valve 200 is in the 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 present disclosure, the valve 400 has a skirt 260 including an inner end 220 that is coupled to the bottom end 208 of the head at a position radially inward relative to the outer surface of the head 204. Thus, the 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 present disclosure, valve 500 has a skirt 260 including an inner end 220 coupled to bottom end 208 of head 204 such that skirt extends radially outward from head 204 at an angle transverse to an outer surface of head 204. When valve 500 is in an open configuration, skirt 260 may fold at a transition between head 204 and skirt 260 to form at least a portion of first portion 140 of cavity therebetween.

[0067] Additionally, the valve 400, 500 can include a valve stem 421 having a first end 423 extending from either the head 204 and / or the 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 most distal end of the valve and the second end 425 of the valve stem forms the most proximal end of the valve.

[0068] In an embodiment 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 located between the top end 206 of the head and the second end 425 of the valve stem.

[0069] When the valve is 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, which is configured to enable the second end 425 to 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, so 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 moves 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 guide the head 204 of the valve toward the first housing port 122, thereby guiding 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 having a head and a skirt configured to prevent accidental accumulation of fluid that may leak into the needleless connector by capturing the fluid, preventing fluid movement, and expelling the fluid from the needleless connector. Thus, features of the present disclosure provide a needleless connector with improved reliability performance, and it provides complete transmission of fluid through the needleless connector while also preventing the development of contamination in the needleless connector.

[0072] For example, according to the various aspects described below, the subject technology is shown. For convenience, various examples of various aspects of the subject technology are described below. These are provided only as examples and do not limit the subject technology.

[0073] A needleless connector, comprising: a housing, the housing comprising a first housing port, a second housing port, a cavity extending through the first housing port to a bottom surface of the cavity, and a central pillar extending into the cavity and toward the first housing port, the central pillar having an opening and an inner surface, the inner surface forming a lumen extending between the opening and the second housing port; and a valve, the valve comprising a head and a skirt, the head having an inner surface forming a channel through the head, and the skirt extending radially outward from the head to an outer end of the skirt, the valve being arranged around the central pillar, the valve having an inner surface forming a channel through the head, and the skirt extending radially outward from the head to an outer end of the skirt, the valve being arranged around the central pillar, the valve having an inner surface forming a channel through the head, and the skirt extending radially outward from the head to an outer end of the skirt, the valve being arranged around the central pillar, the valve having an inner surface forming a channel through the head The head is movable longitudinally along the center post and relative to the outer end of the skirt, and the outer end of the skirt is spaced from the cavity floor to fluidly divide 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 and an open configuration, in which the inner surface of the valve engages against the opening to prevent fluid from moving through the center post, and in which the head is biased away from the opening to allow fluid to move through the center post.

[0074] Wherein the head of the valve comprises a split diaphragm forming a portion of the passage extending through the top end of the head.

[0075] wherein, in the closed configuration, the inner surface of the shell 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 shell is spaced apart from the head and the center post extends through the portion of the passage through the top end of the head.

[0076] The outer end of the skirt is located between the opening of the central pillar and the bottom surface of the cavity.

[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] The outer end of the skirt includes a lip forming an outer periphery of the skirt.

[0079] 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 less than the head length.

[0080] Wherein in the open configuration, the skirt extends outwardly from the head in a direction toward a 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 comprises a first volume, and in the open configuration, the first portion of the cavity comprises 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 comprises a first volume, and in the open configuration, the second portion of the cavity comprises 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] The valve stem includes a first end and a second end, the first end is coupled to the head, and the outer end of the skirt is longitudinally located between the head and the second end of the valve stem.

[0087] The valve stem is formed as an elastically compressible bellows between a first end and a 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] 1. A needleless connector, comprising: a housing, the housing comprising a cover portion having a first housing port, a base portion having a second housing port, and a main body portion extending from the cover portion to the main body portion, wherein a valve seat is formed between the cover portion and the main body portion, an inner surface of the housing forms a cavity between the base portion and the cover portion, and a center pillar extends into the cavity, the center pillar having a proximal end, a distal end, an opening, and an inner surface, the inner surface forming a lumen extending between the opening and the second housing port, wherein the center pillar is oriented so that the proximal end is at the base portion and the distal end is between the valve seat and the first housing port; and a valve, the valve comprising a head and a skirt, the head having a top end, a bottom end, and a through-hole forming a through-hole and an inner surface of 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, a bottom end of the head is spaced a first distance from a proximal end of the center post and an inner surface of the valve engages against an opening of the center post to prevent fluid from moving through the opening, and in the open configuration, a bottom end of the head is spaced a second distance from a proximal end of the center post, the second distance being less than the first distance, and an inner surface of the valve is spaced from the opening of the center post to allow fluid to flow through the opening.

[0090] The valve is positioned so that the center post extends into the channel so that a first distance from a bottom end of the head to a distal end of the center post is less than a second distance from the bottom end of the head to a 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] 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 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, the inner surface forming a lumen extending between the opening and the second housing port; and a valve including a head and a skirt, the head being disposed about the center post, 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, wherein the inner surface of the valve engages against the opening of the center post to prevent fluid from moving therethrough, and wherein 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 center post to allow fluid to move therethrough, and wherein the skirt includes a skirt length from the head to an outer end of the skirt, the skirt length increasing as the valve moves from the closed configuration toward the open configuration.

[0095] 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.

[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] The valve includes a valve stem extending around the center post, and the skirt extends around the valve stem.

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

[0099] The present disclosure is provided to enable those skilled in the art to practice the various aspects described herein. The present disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Multiple modifications to these aspects are very clear to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0100] Unless otherwise specified, reference to an element in the singular is not intended to mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter genders (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do 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, the various alternative configurations and operations described herein may be considered to be at least equivalent.

[0102] Phrases such as "aspects" do not mean that such aspects are essential to the subject technology, or that such aspects apply to all configurations of the subject technology. The disclosure associated with an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. Phrases such as "an aspect" may refer to one or more aspects, and vice versa. Phrases such as "embodiments" do not mean that such embodiments are essential to the subject technology, or that such embodiments apply to all configurations of the subject technology. The disclosure associated with an embodiment may apply to all embodiments or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "an embodiment" may refer to one or more embodiments, and vice versa. Phrases such as "constructions" do not mean that such constructions are essential to the subject technology, or that such constructions apply to all configurations of the subject technology. The disclosure associated with a construction may apply to all configurations or one or more constructions. A construction may provide one or more examples. Phrases such constructions may refer to one or more constructions, and vice versa.

[0103] In one aspect, unless otherwise indicated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications in this specification, including those set forth in the claims that follow, are approximate and not exact. In one aspect, they are intended to have a reasonable range consistent with the functions to which they are related and with the customary practices in the art to which they belong.

[0104] In one aspect, the term "coupled" or the like may refer to a direct coupling. In another aspect, the term "coupled" or the like may refer to an indirect coupling.

[0105] Terms such as "top", "bottom", "front", "rear", etc. used in this disclosure should be understood to refer to an arbitrary reference frame other than the common gravitational reference frame. Thus, the top surface, bottom surface, front surface, and rear surface may extend upward, downward, diagonally, or horizontally in the gravitational reference frame.

[0106] Without departing from the scope of the subject technology, various items may be arranged differently (e.g., arranged in a different order, or divided in a different manner). All structural and functional equivalents of the elements of the various aspects described throughout the present disclosure are known to or will be known to those of ordinary skill in the art in the future, and are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, regardless of whether such disclosure is explicitly stated in the claims, the content disclosed herein is not intended to be committed to the public. According to the provisions of the sixth paragraph of 35 U.S.C. §112, the elements of the claims will not be interpreted unless the phrase "means" is used to clearly state the element, or in the case of a method claim, the phrase "step for..." is used to state the element. In addition, for the scope of the terms "including", "having", etc. used, such terms are intended to be inclusive in a manner similar to the term "including", as explained when "including" is used as a transitional word in the claims.

[0107] The title, background technology, content, description of the drawings and abstract of the present disclosure are incorporated into the present disclosure and are provided as illustrative examples of the present disclosure, rather than restrictive descriptions. The submission of this application is based on the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the specific embodiments, it can be seen that the description provides illustrative examples, and in order to simplify the present disclosure, various features are combined together in various embodiments. This disclosure method should not be interpreted as reflecting the intention that the claimed subject matter requires more features than those explicitly stated in each claim. On the contrary, as reflected in the following claims, the subject matter of the invention lies in less than all the features of a single disclosed construction or operation. The claims below are therefore incorporated into the detailed description, and each claim is independently a subject matter claimed separately.

[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 of the claims and including all legal equivalents. Nevertheless, no claim is intended to encompass subject matter that fails to satisfy the requirements of 35 U.S.C. §101, 102, or 103, nor should they be interpreted in such a manner.

Claims

1. A needleless connector, comprising: a housing, the housing comprising a first housing port, a second housing port, a cavity extending through the first housing port to a bottom surface of the cavity, and a central support extending into the cavity and toward the first housing port, the central support having an opening and an inner surface, the inner surface forming a lumen extending between the opening and the second housing port; as well as A valve comprising 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 being arranged around the center post, the head of the valve being movable longitudinally along the center post and relative to the outer end of the skirt, and the outer end of the skirt being spaced from the cavity bottom surface to fluidically separate the cavity of the housing into a first portion of the cavity between the skirt and a first housing port, and a second portion of the cavity between the skirt and a second housing port, the valve having a closed configuration and an open configuration, in which the inner surface of the valve engages against the opening to prevent fluid from moving through the center post, and in which the head is biased away from the opening to allow fluid to move through the center post.

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

3. The needleless connector according to claim 1, wherein: In the closed configuration, the inner surface of the shell 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 shell is spaced apart from the head and the center post extends through the portion of the passage through the top end of the head.

4. The needleless connector according to claim 1, wherein: The outer end of the skirt is located between the opening of the central support and the bottom surface of the cavity.

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

6. The needleless connector according to claim 1, wherein: In the closed configuration, the skirt extends outwardly from the head in a direction away from a top end of the head, and in the open configuration, the skirt extends outwardly from the head in a direction toward the top end of the head.

7. The needleless connector according to claim 1, 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.

8. The needleless connector according to claim 1, wherein: In the closed configuration, the second portion of the cavity comprises a first volume, and in the open configuration, the second portion of the cavity comprises a second volume, and wherein the second volume is greater than the first volume.

9. The needleless connector according to claim 1, 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.

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

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

12. A needleless connector, comprising: a housing including a cover portion having a first housing port, a base portion having a second housing port, and a body portion extending from the cover portion to the body portion, wherein a valve seat is formed between the cover portion and the body portion, an interior surface of the housing forms a cavity between the base portion and the cover portion, and a center post extends into the cavity, the center post having a proximal end, a distal end, an opening, and an interior surface, the interior 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, a bottom end of the head is spaced a first distance from a proximal end of the center post and an inner surface of the valve engages against an opening of the center post to prevent fluid from moving through the opening, and in the open configuration, a bottom end of the head is spaced a second distance from a proximal end of the center post, the second distance being less than the first distance, and an inner surface of the valve is spaced from the opening of the center post to allow fluid to flow through the opening.

13. The needleless connector according to claim 12, wherein: The valve is positioned so that the center post extends into the passageway so that a first distance from a bottom end of the head to a distal end of the center post is less than a second distance from the bottom end of the head to a proximal end of the center post.

14. The needleless connector according to 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 according to 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 according to 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: 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; as well as A valve comprising a head and a skirt, the head being disposed about the center post and the skirt extending radially outwardly from the head to an outer end of the skirt, wherein the valve comprises a closed configuration and an open configuration, wherein in the closed configuration an inner surface of the valve engages against an opening of the center post to prevent fluid from moving therethrough, and in the open configuration the head is displaced in a direction away from the first housing port such that an inner surface of the valve is spaced apart from the opening of the center post to allow fluid to move therethrough, and the skirt comprises a skirt length from the head to an outer end of the skirt, the skirt length increasing as the valve moves from the closed configuration toward the open configuration.

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

19. The needleless connector according to claim 17, 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.

20. The needleless connector of claim 17, wherein: The valve includes a valve stem extending about the center post, and the skirt extends about the valve stem.

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