Patent Description:
Medical treatments often include the infusion of a medical fluid (e.g., a saline solution or a liquid medication) to patients using an intravenous (IV) catheter that is connected though an arrangement of flexible tubing and fittings, commonly referred to as an "IV set," to a source of fluid, for example, an IV bag. Certain needleless connectors may be used in an IV set and may have a self-sealing port to prevent leakage of fluid when a mating medical implement is decoupled from such a needleless connector. Additionally, a needleless connector may include a mechanical valve, for example, a collapsible valve comprising a flexible material for providing the self-sealing port and controlling the flow of fluid within the IV set.

Due to the nature of currently existing and/or prior art needleless valve geometries, fluid is commonly deposited on the face of the valve head upon removal of a medical implement (e.g., a mating male luer) used to apply an axial force to place the valve member in an open position. In these currently existing needless valves, fluid deposited on the valve head will occasionally separate from the valve member and flow into the fluid path for administering to a patient, thereby causing anxiety along with potential blood stream diseases. For example, <CIT> discloses a medical valve having a resilient member that is forcibly expanded to an expanded volume from a normal volume. Specifically, the valve operates in a closed mode that prevents fluid flow, and an open mode that permits fluid flow. To these ends, the valve has a housing having an inlet and an outlet, and the noted resilient member within the housing. The resilient member and housing form a fluid channel between the inlet and the outlet. The fluid channel at least in part extends through the resilient member. The fluid channel at least in part extends through the resilient member. The fluid channel has a given portion formed by a variable volume portion of the resilient member. The variable volume portion has a normal volume when in the closed mode, and an expanded volume when the open mode. The expanded volume is greater than the normal volume. <CIT>discloses needleless connectors. An example needleless connector includes a housing and a compressible valve. The housing may define an internal cavity and may include a body section having a first port and one or more internal contact tabs and a base section having a valve mount and a second port. The compressible valve may be disposed within at least a portion of the internal cavity and be movably retained within the housing. The compressible valve may include a flange portion for securing the compressible valve within the housing. A central longitudinal axis of the housing may be defined by a coaxial arrangement of the first and second port. The one or more internal contact tabs may be arranged to contact an outer side surface of the flange portion such that a radial force substantially orthogonal to the central longitudinal axis is provided for securement. And <CIT> discloses needleless access port valves having a piston comprising slit along an upper piston section for accommodating fluid flow. The slit opens when the piston is compressed by a medical implement, such as a syringe tip, to permit fluid communication between the inlet and the outlet of the vale housing. The slit may be cut using high frequency cutting machine or a multi-axis robot arm and a cutting blade.

An aspect of the present disclosure provides a needleless connector, comprising a housing and a compressible valve. The housing can have a proximal end defining an inlet port of the housing, a distal end including a base defining an outlet port of the housing, and an inner surface defining an internal cavity extending between the inlet and outlet ports. The compressible valve can be reciprocally disposed within the internal cavity of the housing and can be configured to contact at least a portion of the inner surface. The compressible valve can comprise a head portion and a compressible body portion extending distally from the head portion. In a closed state of the compressible valve, a top section of the head portion of the compressible valve can have a planar shape configured to contact and seal against the inner surface of the housing, and wherein in an open state, where the compressible valve is subject to an axial force, the top section of the head portion can be lodged between two pinch points thereof between opposing walls of an inwardly angled portion of the internal surface, and the top section of the head portion can have a non-planar shape defining a fluid path extending at least partially between opposing walls on an outwardly angled portion of the internal surface.

Only exemplary, some instances of the present disclosure provide a needleless connector, comprising a housing and a compressible valve. The housing can have a body including an inlet of the housing, a base including an outlet of the housing, and an internal cavity defined by an internal surface of the body. The compressible valve can be disposed within the internal cavity, and the compressible valve can comprise a head portion and a compressible body portion. The head portion can include a top section and a top surface. The top section can have an outer periphery configured to contact and seal against the internal surface in a closed state, and lodge between pinch points at opposing walls of the internal surface within the inlet when the head portion is subject to an axial force. The top surface can form an upper boundary of the top section, the top surface defining a fluid path which extends between the pinch points when the head portion is subject to the axial force. The compressible body portion can extend distally from the head portion.

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 as claimed. It is also to be understood that other aspects may be utilized, and changes may be made without departing from the scope of the subject technology.

The following figures are included to illustrate certain aspects of the embodiments, and should not be viewed as exclusive embodiments. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure.

Various embodiments of the present disclosure are generally directed to a self-sealing, needleless connector that incorporates a flexible, compressible valve disposed within a housing of the connector, in which opening of the fluid path for administering of the medicinal fluid to the patient is not dependent on tilting or collapsing of the valve head. More particularly, various embodiments of the present disclosure are directed to a needleless connector having a housing and a compressible valve configured such that when subject to an axial force, tilting of the head portion of the compressible valve (which forms the fluid flow path in existing needleless connectors) is eliminated. Instead, in the various embodiments of the present disclosure, when subject to the axial force, a concave flow surface defining at least a portion of the fluid flow path is formed on a top surface of the head portion. As the axial force is removed, the top surface of the head portion (valve head) returns to the substantially flat or planar configuration, thereby creating a "face seal" before it is fully removed.

According to various embodiments of the present disclosure, when subj ected to the axial force, the compressible valve is designed to allow two portions of an outer periphery of the top surface of the head portion (valve head) to be pinched or otherwise lodged between two points on opposing inwardly-angled internal walls of the housing. The two portions, and accordingly the two points on the housing (referred to herein as "pinch points") may be positioned about <NUM> degrees apart from each other. Accordingly, the housing inner diameter is designed to pinch the compressible valve at the two "pinch points," as well as to open up a flow path oriented <NUM> degrees to each of the pinch points without tilting or otherwise compressing the valve head. In particular, the housing may further be configured with a section of opposing outwardly-angled internal walls such that when the compressible valve is subject to the axial force and in the open state, a gap may be opened between the top section of the valve head and the outwardly-angled internal walls. The gap completes the fluid flow path by fluidly communicating the concave flow surface with the interior of the housing.

In order to prevent the valve head from tilting or otherwise compressing, the valve member of the various embodiments described herein may advantageously include a core member disposed axially along at least a portion of a length of the compressible valve. The core member may be disposed in the valve head extending along a central longitudinal axis of the needleless connector housing, and in some embodiments terminating at the compressible portion of the compressible valve. Accordingly, the core member may act as a support column to prevent the valve head from tilting or being otherwise deformed when the axial force is applied thereto.

When the two portions of the head portion are pinched between the two points on the opposing inwardly-angled inner walls of the housing, the top surface of the valve head transitions from a substantially flat planar surface to a concavely shaped recess or depression. The flow path may be defined by the concavely shaped recess or depression and the gap existing between the top section the valve head and the outwardly-angled internal walls. Accordingly, formation of the flow path occurs without tilting or compressing of the head portion (valve head) of the compressible valve.

As the medical implement (e.g., a mating male luer) is removed from the housing, the top surface of the valve head returns to the substantially flat or planar configuration, thereby creating a "face seal" before it is fully removed. The flat or planar shape of the top surface of the valve head advantageously minimizes the fluid capable of being deposited on the face, thereby preventing anxiety along with potential blood stream diseases commonly associated with fluids deposited on the face (top surface) of the valve head.

While the following description is directed to the administration of medical fluid to a patient by a medical practitioner using the disclosed needleless connector, it is to be understood that this description is only an example of usage and does not limit the scope of the claims.

<FIG> is a perspective view of a housing <NUM> of a needleless connector, in accordance with some embodiments of the present disclosure. As depicted, the housing <NUM> may have a proximal end <NUM> defining an inlet port <NUM> of the housing <NUM> and a distal end <NUM> including a base <NUM> defining an outlet port <NUM> (illustrated in <FIG>) of the housing <NUM>, In some embodiments, the housing <NUM> may further include an inner surface <NUM> defining an internal cavity <NUM> which extends at least partially between the proximal and distal ends <NUM> and <NUM>. The housing <NUM> may be formed of a body portion <NUM> and a base portion <NUM>. However, in some embodiments, the housing may be formed from a combination of other pieces or parts similarly dimensioned to house the compressible valve <NUM> therein. In operation, a fluid pathway may be established through needleless connector from the inlet port <NUM> to the outlet port <NUM>, for example.

<FIG> is a cross-sectional view of the housing <NUM> of the needleless connector of <FIG>, in accordance with some embodiments of the present disclosure. <FIG> illustrates the cross-sectional view of the housing of <FIG> rotated <NUM> degrees, in accordance with some embodiments of the present disclosure. As depicted, the housing <NUM> may include inlet port <NUM> for interfacing with a medical implement (e.g., a male luer <NUM> (illustrated in <FIG>)) and an opening <NUM> for connecting with the base <NUM> (shown in <FIG>) of the housing <NUM>. As depicted, body portion <NUM> of the housing <NUM> may include one or more fluid flow channels <NUM> and one or more interior support columns <NUM>. The lower section of the body portion <NUM> (e.g., a section proximal to the opening <NUM>) may have an increased diameter and include one or more internal contact tabs <NUM>. When assembled in a needleless connector, the one or more internal contact tabs <NUM> provide a radial force substantially orthogonal to the central longitudinal axis X onto a flange portion of a compressible valve (e.g., compressible valve <NUM> illustrated in FIGS. 3A-3C) that is arranged on a valve mount of the base portion <NUM>.

In accordance with various embodiments of the present disclosure, the inlet port <NUM> may include a top port surface <NUM> and a channel defined in the internal cavity <NUM>. The inlet port <NUM> may include engagement features <NUM> for coupling to another device (e.g., a fluid transfer assembly). For example, engagement features <NUM> may include cooperating mechanical elements, such as internal or external surface threads, detents, bayonet-type locking elements, etc., as well as other surface configurations, such as a tapered Luer surface for frictional engagement. In some embodiments, the inlet port <NUM> may define a female luer fitting with luer lock threading <NUM>.

The inner surface <NUM> and the internal cavity <NUM> defined therein may extend longitudinally from the opening of the top port surface <NUM> of the inlet port <NUM> into the body portion <NUM> of the housing <NUM>. In some embodiments, as depicted in <FIG>, the inner surface <NUM> may be formed of a first section of opposing walls <NUM> which are angled inwardly. In particular, the walls <NUM> may extend distally from the proximal end <NUM> of the housing <NUM> at an angle, which is slanted inwards towards the central longitudinal axis X of the housing <NUM>. As referred to herein, proximally refers to an orientation toward the top port surface <NUM> of the housing <NUM>, and distally refers to an orientation toward the base portion <NUM> or bottom of the housing <NUM>, opposite the top port surface <NUM>.

The opposing walls <NUM> may serve as inwardly angled portions of the internal surface <NUM> between which a top section <NUM> of the head portion <NUM> of the compressible valve <NUM> may become lodged when subject to the axial force F, as illustrated in, and as shall be further described with respect to <FIG> below.

In some embodiments, as depicted in <FIG>, the inner surface <NUM> may further be formed of a second section of opposing walls <NUM> which are angled outwardly. In particular, the walls <NUM> may extend distally from the proximal end <NUM> of the housing <NUM> at an angle, which is slanted outwards away from the central longitudinal axis X of the housing <NUM>. The opposing walls <NUM> may serve as outwardly angled portions of the internal surface <NUM>, whereby a gap may exist between the top section <NUM> of the head portion <NUM> of the compressible valve <NUM> and the internal surface <NUM> when the compressible valve <NUM> is subject to an axial force and in the open state, as illustrated in, and as shall be further described with respect to <FIG> below. In this open state of the compressible valve, the gap serves as a flow path <NUM> through which fluid may flow into the cavity <NUM> within the body portion <NUM> of the housing, and out through the outlet <NUM>, as shall be described further below.

In accordance with some embodiments, as depicted in <FIG>, the opposing walls <NUM> on the outwardly angled portion of the internal surface <NUM> may each be spaced approximately <NUM> degrees apart from the opposing walls <NUM> of the inwardly angled portion of the internal surface <NUM> on which pinch points P (illustrated in <FIG>) are located. As described herein the term "pinch point" refers to a position on the housing <NUM> where the compressible valve <NUM> becomes lodged otherwise "pinched" between the inwardly angled walls <NUM> of the housing <NUM> when the compressible valve <NUM> is subject to an axial force F which displaces the compressible valve <NUM> distally. The decreased clearance between the compressible valve <NUM> and the inwardly angled opposing walls <NUM> where the pinch points P are positioned resulting from the decrease in diameter of the internal cavity <NUM> at the inwardly angled walls <NUM>, causes the top section <NUM> of the head portion <NUM> of compressible valve <NUM> to become lodged or otherwise "pinched" between angled opposing walls <NUM>. The positions on the inwardly angled walls <NUM> between which the top section <NUM> of the head portion is "pinched" are referred to herein as the "pinch points. " Continued application of the axial force to the top surface <NUM> of the head portion while the top section <NUM> is "pinched" between the opposing walls <NUM> causes the top surface <NUM> to contort, bend, or otherwise be reversibly or elastically deformed into the shape of a concave groove, depression, or recess <NUM> which forms a portion of the flow path <NUM> as shall be described in further detail with respect to <FIG>.

In some embodiments, an internal sealing edge <NUM> may be defined on the inner surface <NUM> of the housing <NUM>. The internal sealing edge <NUM> may be a circumferential edge and configured for retaining the compressible valve <NUM> (illustrated in FIGS. 3A-3C) within the internal cavity <NUM> of the assembled needleless connector (illustrated in <FIG>). In operation, the internal sealing edge <NUM> may be arranged to provide blocking of fluid flow in conjunction with a primary seal portion of the compressible valve <NUM>.

As depicted, fluid flow channels <NUM> may alternate with interior support columns <NUM>. In some embodiments, fluid flow channels <NUM> may be smaller than the interior support columns <NUM>. Additionally, fluid flow channels <NUM> may further extend into the lower portion of the body portion <NUM> between adjacent internal contact tabs <NUM>. In this regard, a fluid path may be extended to the base portion <NUM> of the housing <NUM> coupled to the body portion <NUM> and further to the outlet port <NUM> (illustrated in <FIG>).

<FIG> is a perspective view illustrating an example of a compressible valve of a needless connector, in accordance with some embodiments of the present disclosure. <FIG> is a cross-sectional view of the compressible valve of <FIG>, in accordance with some embodiments of the present disclosure. <FIG> illustrates the cross-sectional view of the compressible valve of <FIG> rotated <NUM> degrees, in accordance with some embodiments of the present disclosure.

<FIG> illustrate in isolation an example compressible valve <NUM>. Compressible valve <NUM> may include head portion <NUM>, and compressible body portion <NUM> extending distally from the head portion <NUM>. In certain embodiments, the head portion <NUM> includes a column section <NUM> having an axial center C substantially corresponding to the central longitudinal axis X of the needleless connector housing <NUM> when assembled therein. The central longitudinal axis C may extend longitudinally through the head portion <NUM> and the body portion <NUM> of the compressible valve <NUM>. As depicted, the body portion <NUM> of the compressible valve <NUM> may have the same axial center as the head or other portions of the compressible valve <NUM>. Moreover, the axial centers of compressible valve sections may be substantially aligned with the central longitudinal axis X of the needleless connector housing <NUM> in both a non-activated state (e.g., in isolation or within a connector but not displaced by a medical implement) and in an activated state (e.g., when an axial force is applied to the compressible valve <NUM> using the medical implement, for example male luer <NUM> (illustrated in <FIG>)). Unlike existing compressible valves in which the axial centers of compressible valve sections will change and pivot in relation to the central longitudinal axis upon the compressible valve being activated by a medical implement, the compressible valve <NUM> of the various embodiments described herein is configured so as to maintain alignments of the axial center C of the compressible valve <NUM> with the central longitudinal axis X of the needleless connector housing <NUM>. In particular, in order to achieve this configuration, the compressible valve <NUM> includes a core member <NUM> disposed axially along at least a portion of a length of the compressible valve <NUM>. As depicted, the core member <NUM> is disposed in the head portion <NUM> extending along the central longitudinal axis X of the needleless connector housing <NUM> and terminating at the compressible portion <NUM> of the compressible valve <NUM>. Accordingly, the core member <NUM> may act as a support column to prevent the head portion <NUM> of the compressible valve <NUM> from tilting or being otherwise deformed when the axial force is applied thereto.

In accordance with some embodiments, the head portion <NUM> of the compressible valve <NUM> may have a top section <NUM> that includes a top surface <NUM>. The top section <NUM> may be in the form of a circumferential lip or similar protrusion for slidably and sealably engaging with the inlet port <NUM> of the needleless connector housing <NUM>. In the assembled configuration of the compressible valve <NUM> and the housing <NUM>, the top surface <NUM> may be oriented at a perpendicular plane angle with respect to the central longitudinal axis X as illustrated in <FIG>. In some embodiments, the head portion <NUM> includes at least one notch <NUM> disposed along the exterior thereof, adjacent to, and disposed distally to the top section <NUM>. For example, as depicted, the head portion <NUM> may include two notches <NUM> disposed on opposing sides of the exterior of the column section <NUM> of body portion <NUM>. The notches <NUM> may be configured as arcuate-shaped recesses within the column section <NUM>. However, it is to be appreciated that the implementations of notches may comprise a variety of shapes and sizes, such as, but not limited to, notches having arcuate, triangular, polygonal, or various geometric cross-section shapes, for example. The aforementioned configuration of the notches <NUM> disposed on the head portion <NUM> allows for the top surface <NUM> of the compressible valve member <NUM> to bow distally when the head portion <NUM> is subjected to the axial force and the opposing ends of the top section <NUM> are pinched between and within the inner surface <NUM> of the housing <NUM>. Accordingly, a concave flow channel may be formed or otherwise defined on the top surface <NUM> when the head portion <NUM> is subjected to the axial force, as shall be described in further detail with respect to <FIG>.

In some embodiments however, the column section <NUM> of head portion <NUM> of the compressible valve <NUM> may not include notch <NUM>, but may instead have a discontinuity segment disposed thereon that operates in a similar manner as the notch <NUM>. For example, one side or a portion of each side of the head portion <NUM> may be formed of a different material (or a same material with a different hardness value) than the remainder of the head portion <NUM>.

According to various embodiments of the present disclosure, body portion <NUM> of the compressible valve <NUM> may be in the form of an elongated compressible cylindrical body including a series of concentrically disposed compressible segments <NUM>. The concentrically disposed compressible segments <NUM> are configured such that when an axial force is applied to the head portion <NUM> of the compressible valve <NUM>, the compressible segments <NUM> compress in order to allow for downward (i.e., distal) displacement of the compressible valve <NUM>. Accordingly, a flow path fluidly connecting the inlet port <NUM> and the outlet port <NUM> may be opened, as shall be described in further detail with respect to <FIG>. In some embodiments, the body portion <NUM> may further be coupled to or otherwise integrally formed with a flange portion <NUM> for securing the compressible valve <NUM> within the housing <NUM>. As depicted, the flange portion <NUM> may be disposed along the compressible body portion <NUM> of the compressible valve.

The compressible valve <NUM> of the various embodiments described herein provides several advantages over prior art or otherwise existing compressible valves in which upon application of an axial force, the head portion further compresses, collapses, cants, and/or folds to open up a flow path in response to the axial force. Due to the compressed, collapsed, canted, and/or folded configurations of the prior art compressible valve head portions, it is not possible to maintain coaxial alignments of the axial center C of the compressible valve <NUM> with the central longitudinal axis X of the needleless connector housing <NUM>. Accordingly, due to the geometrical configuration of the currently existing needleless valves, when the axial force is applied to the prior art compressible valves, deformation and compression of the head portion would prevent the desired pinching of the valve head portion between opposing walls to form the concave flow channel. Instead, the flow channel in the currently existing needless valves would be formed as a result of the tilting, collapsing, and compressing of the compressible valves. Because the prior art compressible valve heads need additional time to decompress in order to return back to the undeformed state after removal of the axial force, the prior art compressible valves suffer the deficiency that during the time it takes to decompress, fluid collects and deposits on the top surface of the valve head. The depositing of fluid on the valve head is disadvantageous because the deposited fluid will occasionally separate from the valve and enter the fluid for administering the medicinal fluids to the patient, thereby causing anxiety along with possible blood stream disease.

In contrast, as the medical implement (e.g., male luer) applying the axial force F is removed from the housing <NUM> of the needleless connector of the various embodiments described herein, the top surface <NUM> of the valve head returns to the substantially flat or planar configuration before the medical implement is even fully removed, thereby advantageously creating a face seal before fluid deposits on the top surface <NUM>. The flat or planar shape of the top surface of the valve head which creates the face seal advantageously minimizes the fluid capable of being deposited on the face. Accordingly, anxiety along with potential blood stream diseases commonly associated with fluids deposited on the face (top surface) of the valve head may be minimized or otherwise prevented from occurring.

Thus, the needless connector <NUM> of the various embodiments described herein is configured such that when subject to an axial force F, tilting of the head portion <NUM> of the compressible valve <NUM> is eliminated. In particular, when subjected to the axial force F, the compressible valve <NUM> of the various embodiments described herein is designed to allow two portions of an outer periphery of the top surface <NUM> of the head portion (otherwise referred to as the valve head) <NUM> to be pinched or otherwise lodged between two pinch points on opposing inwardly-angled internal walls of the housing <NUM>. Accordingly, the inner diameter of the housing <NUM> is designed to pinch the compressible valve at the two pinch points, and to also open up a flow path oriented <NUM> degrees to each of the pinch points without tilting or otherwise compressing the head portion <NUM>. The housing <NUM> may further be configured with a section of opposing outwardly-angled internal walls such that when the compressible valve <NUM> is subject to the axial force and in the open state, a gap which forms part of the flow path <NUM> may be opened between the top section <NUM> of the head portion and the outwardly-angled internal walls <NUM>.

<FIG> is a perspective view of a partial cutaway of a housing of a needleless connector <NUM> having a compressible valve <NUM> installed therein in a closed state, in accordance with some embodiments of the present disclosure. <FIG> is a cross-sectional view of the assembled needleless connector housing and compressible valve of <FIG>, in accordance with some embodiments of the present disclosure. <FIG> is a cross-sectional view of the assembled needleless connector housing and compressible valve of <FIG> rotated <NUM> degrees, in accordance with some embodiments of the present disclosure.

In accordance with various embodiments of the present disclosure, as previously described above, the distal end of the housing <NUM> forming the base <NUM> may include the outlet port <NUM> for interfacing with a medical implement, and a valve mount <NUM>. The valve mount <NUM> may comprise a rim <NUM> that defines a recess with one or more air passages. The base <NUM> may further include the one or more fluid passages <NUM> for completing a fluid flow path from the internal cavity <NUM> of the housing <NUM> to the outlet port <NUM> of the base <NUM>.

The base portion <NUM> may be dimensioned to be coupled to or otherwise integrally formed with the body portion <NUM> to create the housing <NUM> of the needleless connector <NUM>. In some embodiments, the outlet port <NUM> may include engagement features for coupling to another device or coupling to interconnect tubing. For example, the outlet port <NUM> may comprise a male luer-taper fitting and luer lock threading (not shown) for medical device implement interconnection. However, engagement features of the outlet port <NUM> may include other cooperating mechanical elements.

<FIG> provide a longitudinal cross-sectional view of a needleless connector <NUM> showing the compressible valve <NUM> in the housing <NUM> formed by the body portion <NUM> and the base portion <NUM>. The assembled needleless connector <NUM> as illustrated in <FIG> is in a sealed configuration such that any fluid from an interconnected fluid path coupled to the outlet port <NUM> is sealed from the inlet port <NUM>. In some embodiments, the needleless connector <NUM> may be assembled such that the flange portion <NUM> of the compressible valve <NUM> is coupled, snapped, or otherwise attached onto the valve mount <NUM> of the base portion <NUM>.

The internal cavity <NUM> of the housing <NUM> may be arranged on top of the compressible valve <NUM> coupled to the base portion <NUM> such that the head portion <NUM> of the compressible valve <NUM> is aligned and disposed within the inlet port <NUM>. Upon assembly, the top surface <NUM> of the head portion <NUM> of the compressible valve <NUM> may have a resulting plane that is substantially perpendicular to the central longitudinal axis X or axial center of the column section <NUM> of the head portion <NUM> when the head portion <NUM> is engaged within the inlet port <NUM> of the housing <NUM>. Additionally, the one or more internal contact tabs <NUM> (illustrated in <FIG>) disposed on the lower section of the body portion <NUM> surround and apply pressure to a sidewall of the flange portion <NUM> to secure and/or anchor the compressible valve <NUM> in the housing <NUM>. In operation, the compressible valve <NUM> of the needleless connector can compress and collapse when an axial force is applied to the top surface <NUM> of the compressible valve <NUM> and expand and realign when the axial force is removed, as shall be described in further detail below.

Accordingly, the one or more internal contact tabs <NUM> may provide a radial force substantially orthogonal to the central longitudinal axis X onto the sidewall of the flange portion <NUM>. In this regard, when the axial force is applied to the top surface <NUM> of the head portion <NUM> of the compressible valve <NUM>, the effect of any resulting axial force through the compressible valve <NUM> onto the base <NUM> of the housing <NUM> is reduced if not eliminated. Such a resulting axial force applied onto the base <NUM> can work against or in derogation, for example, to a fused connection between the base <NUM> and the body portion <NUM>, and over time may disadvantageously cause the fused connection to become breached and/or separated.

<FIG> depict the needleless connector <NUM> in a closed state, for example before an axial force F has been applied to the top surface <NUM> of the head portion <NUM> of the compressible valve <NUM>, or in some embodiments, after the applied axial force F has been released from the top surface <NUM> of the head portion <NUM>, and the top surface <NUM> has realigned with the opening of the inlet <NUM>.

As depicted in <FIG>, the inner surface <NUM> may be dimensioned so as to suitably house the compressible valve <NUM> therein. In particular, the inner surface <NUM> at the inlet <NUM> of the housing <NUM> may be dimensioned so as to slidably accommodate the top section <NUM> in the housing <NUM>. In some embodiments, the top section <NUM> of the compressible valve member <NUM> may be configured to seal between the inner surface <NUM> of the housing and an outer periphery of the head portion <NUM> when the needleless connector <NUM> is in the closed state illustrated in <FIG>. In particular, in the closed state of the compressible valve <NUM>, the top section <NUM> of the head portion <NUM> may have a planar or otherwise substantially flat shape configured to contact and seal against the inner surface <NUM> of the housing <NUM>. Accordingly, fluid flow between the inlet port <NUM> and the outlet port <NUM> may be blocked.

<FIG> depict the needleless connector <NUM> in an open state, for example when an axial force is been applied to the top surface <NUM> of the head portion <NUM> of the compressible valve. <FIG> is a perspective view of a partial cutaway of a housing <NUM> of a needleless connector <NUM> having the compressible valve <NUM> installed therein with an axial force applied to place the valve <NUM> in the open state, in accordance with some embodiments of the present disclosure. <FIG> is a cross-sectional view of the assembled needleless connector housing and compressible valve of <FIG>, in accordance with some embodiments of the present disclosure. <FIG> is an enlarged partial view of a top surface of the compressible valve of <FIG>, in accordance with some embodiments of the present disclosure.

<FIG> provide longitudinal cross-sectional views of the needleless connector <NUM> showing the compressible valve <NUM> upon initial entry of a medical implement <NUM> into the inlet port <NUM>. As medical implement <NUM> (e.g., a male luer having a central channel <NUM>, a syringe, or any other medical implement capable of transferring a fluid into the needleless connector <NUM>) is inserted into the inlet port <NUM> of the needleless connector <NUM>, an axial force F from the medical implement <NUM> is exerted onto the compressible valve <NUM> such that the compressible valve <NUM> is displaced distally within the housing <NUM>. As the compressible valve <NUM> is displaced distally, an outer periphery of top section <NUM> of the head portion <NUM> may become lodged, at pinch points P, between the opposing walls <NUM> which extend distally from the proximal end <NUM> of the housing <NUM> at an angle which is slanted inwards towards the central longitudinal axis X of the housing <NUM>. As the top section <NUM> becomes lodged between the pinch points P of the opposing walls <NUM> and the axial force continues to displace the compressible valve <NUM> distally, the top section <NUM> of the head portion <NUM> may slightly bow distally as illustrated at the top surface <NUM> in <FIG>. As a result, the top surface <NUM> of the top section <NUM> of the compressible valve <NUM> may deform from the planar shape (where no axial force F was applied) to a non-planar shape <NUM>. In accordance with some embodiments, the non-planar shape <NUM> may define at least a portion of the fluid path <NUM> extending at least partially between the opposing walls <NUM> on the outwardly angled portion of the internal surface <NUM>, as shall be further described with respect to <FIG>.

In particular, the non-planar shape <NUM> of the top section <NUM> that defines at least a portion of the flow path <NUM> may be in the shaped as a concave groove, depression, or recess <NUM> which opens into the flow path <NUM> as shall be described in further detail with respect to <FIG>. Accordingly, the flow path <NUM> may be defined by the concave groove, depression, or recess of the non-planar shape <NUM> and the gap existing between the top section <NUM> of the head portion <NUM> of the compressible valve <NUM> and the internal surface <NUM> in the open state of the compressible valve <NUM>.

As depicted, during application of the axial force F, the core member <NUM> which is disposed axially along the length of the head portion <NUM> maintains axial alignment of a central longitudinal axis of the compressible valve member and a central longitudinal axis of the housing when the axial force is applied. In particular, the core member <NUM> may ensure that the head portion is not otherwise deformed or collapsed by the axial force F, other than the bowing or deflecting of the top surface <NUM> of the top section <NUM> where the concave recess <NUM> of the fluid flow path <NUM> is formed.

In some embodiments, the pinch points P may be spaced part from each other. In particular, as described above, each pinch point P may be located on opposite sides of the opposing walls <NUM>, as depicted in <FIG>. Accordingly, in some embodiments, the pinch points P may be positioned on the opposing walls <NUM> at an angle approximately <NUM> degrees apart from each other. For example, as depicted in <FIG>, the pinch points P may be positioned opposite and across from each other along a common axis Y extending through the pinch points P.

<FIG> is a cross-sectional view of the assembled needleless connector housing <NUM> and compressible valve <NUM> of <FIG> rotated <NUM> degrees, in accordance with some embodiments of the present disclosure. <FIG> is an enlarged partial view of the top surface <NUM> of the compressible valve <NUM> of <FIG>, in accordance with some embodiments of the present disclosure. <FIG> depict provide longitudinal cross-sectional views of the needleless connector <NUM> showing the compressible valve <NUM> upon initial entry of a medical implement <NUM> into the inlet port <NUM>.

As previously described with respect to <FIG>, the recess defined by the non-planar shape <NUM> formed on the top surface <NUM> of the head portion <NUM> as a result of application of the axial force F in conjunction with pinching of the top section <NUM> between pinch points P of opposing walls <NUM> of the housing may define a portion of fluid path <NUM> extending at least partially between opposing walls <NUM> on the outwardly angled portion of the internal surface <NUM>. <FIG> provide longitudinal cross-sectional views of the needleless connector <NUM> rotated <NUM> degrees from the views illustrated in <FIG>. As previously described, the medical implement <NUM> may be used to apply the axial force F to distally displace the compressible valve <NUM> within the housing <NUM>. As the compressible valve <NUM> is displaced distally and the outer periphery of top section <NUM> of the head portion <NUM> becomes lodged at pinch points P on opposing inwardly-angled walls <NUM>, the fluid path (illustrated by the arrows) defined at least in part by the non-planar shape of the top section <NUM> of the head portion between the pinch points P is opened into the internal cavity <NUM> of the housing <NUM>. As previously discussed, the opposing walls <NUM> may serve as outwardly angled portions of the internal surface <NUM> where a gap may exist between the top section <NUM> of the head portion <NUM> of the compressible valve <NUM> and the internal surface <NUM> when the compressible valve <NUM> is subject to an axial force and in the open state. In this open state of the compressible valve, the gap serves as a path through which fluid may flow into the cavity <NUM> within the body portion <NUM> of the housing, and out through the outlet <NUM>. In accordance with some embodiments, as previously described with respect to <FIG>, the opposing walls <NUM> on the outwardly angled portion of the internal surface <NUM> may each be spaced approximately <NUM> degrees apart from the opposing walls <NUM> of the inwardly angled portion of the internal surface <NUM> on which pinch points P (illustrated in <FIG>) are located. Accordingly, the flow path <NUM> defined by the concave groove, depression, or recess <NUM> and the gap existing between the top section <NUM> of the head portion <NUM> of the compressible valve <NUM> and the internal surface <NUM> in the open state of the compressible valve <NUM>, may be oriented orthogonally to the common axis Y extending through the pinch points P.

As depicted, in the open state of the compressible valve <NUM>, fluid may flow from the central channel <NUM> of the medical implement <NUM> positioned in the inlet <NUM> into the concave shaped recess <NUM> of flow path <NUM> in the cavity <NUM>, and out through the outlet port <NUM>. A medical fluid may thus be administered to a patient through the outlet port <NUM> of the housing <NUM>.

In some embodiments, once the axial force F is removed and the compressible valve <NUM> transitions back to the closed state, pinching force between the inner surface <NUM> of the housing <NUM> and the top section <NUM> of the head portion <NUM> at each of the pinch points may be released and the top section <NUM> where the concave shaped recess <NUM> of fluid path <NUM> is defined may transition from the concave shape back to the planar shape.

Accordingly, the configuration of the needleless connector <NUM> of the various embodiments described herein is advantageously designed to pinch the compressible valve <NUM> at the two "pinch points," of the housing <NUM> in order to open up a flow path oriented <NUM> degrees to each of the pinch points without tilting or otherwise compressing the valve head. In order to prevent the valve head from tilting or otherwise compressing, the core member <NUM> is disposed axially along at least a portion of a length of the compressible valve, extending along a central longitudinal axis of the needleless connector housing, and in some embodiments terminating at the compressible portion of the compressible valve. Advantageously, the core member may act as a support column to prevent the valve head from tilting or being otherwise compressed or deformed when subject to the axial force F. As previously described, when the two portions of the head portion <NUM> are pinched between the two pinch points P, the top surface <NUM> of the valve head transitions from a substantially flat planar surface to a concavely shaped recess or depression. The flow path may thus be defined by the concavely shaped recess or depression and the gap existing between the top section the valve head and the outwardly-angled internal walls. Accordingly, contrary to some compressible valves, formation of the flow path does not occur as a result of tilting or compressing of the head portion (valve head) of the compressible valve, but instead due to the pinching and formation of the concave recess on the top surface <NUM>.

As the medical implement <NUM> applying the axial force F is removed from the housing <NUM>, the top surface <NUM> of the valve head may return to the substantially flat or planar configuration, thereby advantageously creating a face seal before even it is fully removed from the housing <NUM>. The flat or planar shape of the top surface <NUM> of the head portion <NUM> which creates the face seal advantageously minimizes the fluid capable of being deposited on the top surface <NUM> (i.e., the valve face). Accordingly, anxiety along with potential blood stream diseases commonly associated with fluids deposited on the face (top surface) of the valve head may be minimized or otherwise prevented from occurring.

Claim 1:
A needleless connector (<NUM>), comprising:
a housing (<NUM>) having a proximal end (<NUM>) defining an inlet port (<NUM>) of the housing, a distal end (<NUM>) including a base (<NUM>) defining an outlet port (<NUM>) of the housing, and an inner surface (<NUM>) defining an internal cavity (<NUM>) extending between the inlet and outlet ports; and
a compressible valve (<NUM>) reciprocally disposed within the internal cavity (<NUM>) and configured to contact at least a portion of the inner surface (<NUM>), the compressible valve comprising a head portion (<NUM>) and a compressible body portion (<NUM>) extending distally from the head portion,
wherein:
in a closed state of the compressible valve, a top section (<NUM>) of the head portion of the compressible valve (<NUM>) has a planar shape configured to contact and seal against the inner surface of the housing; and
in an open state, where the compressible valve (<NUM>) is subject to an axial force:
the top section (<NUM>) of the head portion is lodged between two pinch points (P) thereof between opposing walls (<NUM>) of an inwardly angled portion of the internal surface (<NUM>); and
the top section (<NUM>) of the head portion has a non-planar shape defining a fluid path extending at least partially between opposing walls (<NUM>) on an outwardly angled portion of the internal surface (<NUM>).