Needleless connector having check valve with lip seal

A valve member for a connector includes a head portion, a body portion, and a circumferential lip seal extending radially outward from an outer surface of the head portion. The head portion includes a top section defining a first seal portion. The body portion extends longitudinally from the head portion and defines a second seal portion at a proximal end thereof. The second seal portion is disposed distally to the first seal portion. The circumferential lip seal is disposed between the first and second seal portions.

TECHNICAL FIELD

The present disclosure relates generally to needleless connectors, and, in particular, to needleless connectors with a valve member having a sealing lip.

BACKGROUND

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 needleless 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.

SUMMARY

In accordance with some embodiments of the present disclosure, a valve member for a connector may include a head portion including a top section defining a first seal portion, and a body portion extending longitudinally from the head portion and defining second seal portion at a proximal end thereof. The second seal portion may be disposed distally to the first seal portion. The valve member may further include a circumferential lip seal extending radially outward from an outer surface of the head portion. The circumferential lip seal may be disposed between the first and second seal portions.

In accordance with some embodiments of the present disclosure, a needleless connector may include a housing having 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 needleless connector may further include a resilient valve disposed within at least a portion of the internal cavity and movably retained within the housing. The resilient valve may include a head portion including a top section and a body portion extending distally from the head portion; and a circumferential lip seal extending radially outward from an outer surface of the head portion and disposed between the top section and the body portion. In an open state of the resilient valve where a gap exists between the inner surface of the housing and the outer surface of the head portion, the circumferential lip seal may engage at least a portion of the inner surface of the housing to obstruct fluid from flowing from the internal cavity towards and onto the top section of 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.

DETAILED DESCRIPTION

It is to be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed according to particular but non-limiting examples. Various embodiments described in the present disclosure may be carried out in different ways and variations, and in accordance with a desired application or implementation.

Various embodiments of the present disclosure are generally directed to a self-sealing, needleless connector that incorporates a resilient, compressible valve disposed within a housing of the connector, in which the resilient valve has a circumferential lip seal that acts as a wiper or dam that engages the inner surface (inner diameter) of the housing to prevent fluid from moving from the cavity toward the top of the valve via a temporary gap created between the valve and the housing when the valve is canted, tilted, depressed, or otherwise compressed.

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.

According to various embodiments of the present disclosure, when the axial force is removed, the resilient valve begins to expand to return to its position within the housing in the sealed configuration. As the resilient valve expands, the circumferential lip seal engages the inner surface of the housing and inverts or otherwise bends thereby acting as a wiper or dam that prevents fluid from moving from the cavity of the housing toward the valve face via the temporary gap. Accordingly, the configuration of the valve member of the various embodiments described herein having the circumferential lip seal is advantageous as it prevents droplets of fluid from collecting on the top surface of the valve by obstructing fluid from moving from the cavity to the top surface via the temporary gap. As the circumferential lip seal minimizes the fluid capable of being deposited on the valve face, it advantageously prevents anxiety along with potential blood stream diseases commonly associated with fluids deposited on the valve 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.1is a perspective view of a partial cutaway of a housing110of a needleless connector100having a resilient valve installed therein, in accordance with some embodiments of the present disclosure. As depicted, the housing110may have a proximal end105defining an inlet port112of the housing110and a distal end120including a base portion160defining an outlet port123of the housing110, In some embodiments, the housing110may further include an inner surface130defining an internal cavity133which extends at least partially between the proximal and distal ends105and120of the housing110. The housing110may be formed of a body portion115coupled to or otherwise integrally formed with the base portion160. However, in some embodiments, the housing110may be formed from a combination of other pieces or parts similarly dimensioned to house the resilient valve200therein. In operation, a fluid pathway may be established through needleless connector100from the inlet port112to the outlet port123, for example. As referred to herein, proximally refers to an orientation toward the inlet port112of the housing110, and distally refers to an orientation toward the base portion160or bottom of the housing100, opposite the inlet port112.

As depicted, in addition to housing110including the inlet port112of the housing110for interfacing with a medical implement (e.g., a male luer300(illustrated inFIG.4)), the housing110may further include an opening155for connecting with the base160of the housing110. As depicted, body portion115of the housing110may include one or more fluid flow channels144and one or more interior support columns (not shown). The lower section of the body portion115(e.g., a section proximal to the opening155) may have an increased diameter and include one or more internal contact tabs (not shown). When assembled in a needleless connector100, the one or more internal contact tabs may provide a radial force substantially orthogonal to a central longitudinal axis X1of the housing110onto a flange portion of the resilient valve200that is arranged on a valve mount of the base portion160.

In accordance with various embodiments of the present disclosure, the inlet port112may include a top port surface114and a channel defined in the internal cavity133. The inlet port112may include engagement features135for coupling to another device (e.g., a fluid transfer assembly). For example, engagement features135may 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 port112may define a female luer fitting with luer lock threading135. The inner surface130and the internal cavity133defined therein may extend longitudinally from the opening of the top port surface114of the inlet port112into the body portion115of the housing110.

In some embodiments, an internal sealing edge122may be defined on the inner surface130of the housing110. The internal sealing edge122may be a circumferential edge and configured for retaining the resilient valve200within the internal cavity133of the assembled needleless connector100. In operation, the internal sealing edge122may be arranged to provide blocking of fluid flow in conjunction with a primary seal portion225of the compressible valve200.

FIG.2is a perspective view illustrating an example of a resilient valve of a needleless connector, in accordance with some embodiments of the present disclosure.FIG.2illustrates in isolation an example resilient valve200. Resilient valve200may include head portion220, and body portion230extending distally from the head portion220. In certain embodiments, the head portion220includes a column section218which may define an axial center X2of the resilient valve200. The axial center X2may substantially correspond to the central longitudinal axis X1of the needleless connector housing100when assembled therein in a closed state of the resilient valve200. In a non-activated state (e.g., in isolation or within a connector but not displaced by a medical implement) the axial center X2may extend longitudinally through the head portion220and the body portion230of the compressible valve200(as depicted inFIG.1). In the aforementioned state, the body portion230of the compressible valve200may have the same axial center as the head portion220or other portions of the compressible valve200. However, as described in further detail below, in an activated state (e.g., when an axial force is applied to the compressible valve200using the medical implement, for example male luer300) the axial center X2of the resilient valve200may change and pivot in relation to the central longitudinal axis X1upon the resilient valve200being activated by the medical implement.

In accordance with some embodiments, the head portion220may include a top section212defining a first or secondary seal portion214of the resilient valve200. The body portion230may further define a second or primary seal portion225at a proximal end of the body portion230. As depicted, the primary seal portion225may be disposed distally to the secondary seal portion214.

According to various aspects of the present disclosure, the head portion220may further include a circumferential lip seal215extending radially outward from an outer surface of the head portion220. As depicted, the circumferential lip seal215may protrude radially outward from the outer surface of the head portion220towards the inner surface130of the housing110. The circumferential lip seal215may be a thin, flexible member which engages the inner surface130of the housing110of connector100. For example, as shall be discussed in further detail below, the circumferential lip seal215may form a thin seal (in the order of 0.0005-0.005 inches) that will prevent fluid from flowing from the internal cavity133to the valve face (i.e., top surface216) during removal of the medical implement (e.g., syringe300). Accordingly, the circumferential lip seal215may function to obstruct most of the fluid flowing from the internal cavity from reaching the top surface216of the valve200during removal of the medical implement300. The aforementioned thin and flexible configuration of the circumferential lip seal215is advantageous as the circumferential lip seal215is thin enough to be inverted during syringe insertion and to slide with minimal drag force during syringe removal. Accordingly, the circumferential lip seal215may allow fluid to move in one direction. For example, the circumferential lip seal215may allow fluid to flow or otherwise drain from a first cavity145formed between the circumferential lip seal215and the secondary seal portion214toward a second cavity165formed between the circumferential lip seal215and the primary seal portion225.

In some embodiments, a distance H1that the circumferential lip seal215extends radially outward from the outer surface of the head portion220may be smaller or shorter than a distance H2between the circumferential lip seal215and the first (secondary) seal portion214. The aforementioned configuration allows for the circumferential lip seal215to bend or otherwise deflect upwards towards the secondary seal portion without the risk of breaching or otherwise becoming lodged between the inner surface of the housing130as the valve200expands from the open to the closed state.

In some embodiments, the circumferential lip seal215may be disposed between the first (secondary) and second (primary) seal portions214and225. In particular, as depicted the circumferential lip seal215may be disposed at a position closer to the secondary seal portion214than the primary seal portion225. For example, a distance or height H2may be defined between the circumferential lip seal215and the secondary seal portion214. Similarly, a distance or height H3may be defined between the circumferential lip seal215and the secondary seal portion214. In some embodiments, the distance or height H2may be shorter or smaller than the distance or height H3. The aforementioned configuration is advantageous in order to minimize the volume of fluid which may collect in the first cavity145.

The top section212may include a top planar surface216which is oriented perpendicularly with respect to the axial center X2of the column section218. In some embodiments, as depicted inFIG.2, the circumferential lip seal215may be oriented parallel to and/or concentrically disposed with respect to the top planar surface216. The various embodiments of the present disclosure however, are not limited to the aforementioned configuration. In other embodiments, the circumferential lip seal215may be oriented at a non-parallel angle with respect to the top planar surface216. In these embodiments, during syringe insertion when the head portion220is subject to the axial force F (illustrated inFIG.4) causing the head portion220to cant, bend or otherwise deflect as illustrated, the circumferential lip seal215may be oriented such that it is parallel to the top port surface114. This configuration may be advantageous as the maximum or entire perimeter of the circumferential lip seal215may contact the inner surface130of the housing at same time. Accordingly, sealing capabilities of the circumferential lip seal215may be optimized as the entire perimeter of the circumferential lip seal215engages the inner surface130of the housing110.

As previously described above, and as illustrated inFIGS.1and2, the column section218may define the axial center X2of the head portion220, and the circumferential lip seal215may be oriented substantially perpendicularly with respect to the axial center X of the head portion. The aforementioned configuration allows maximum exposure and engagement of the circumferential lip seal215with the inner surface130of the housing when the resilient valve is in the closed position. In other embodiments, however, the circumferential lip seal215may be oriented at a non-perpendicular angle with respect to the axial center of the head portion. For example, in some embodiments, the circumferential lip seal215may be oriented at an angle such that when the head portion220is subject to the axial force F causing the head portion220to cant, bend or otherwise deflect, the circumferential lip seal215may be oriented such that the maximum or entire perimeter of the circumferential lip seal215may contact the inner surface130of the housing at same time. Accordingly, sealing capabilities of the circumferential lip seal215may be optimized as the entire perimeter of the circumferential lip seal215engages the inner surface130of the housing110.

According to various embodiments of the present disclosure, the head portion220may include at least one notch210disposed along the outer surface of the column section218. As depicted inFIG.2, the column section218may have a generally solid cylindrical section. As can be seen with respect to the longitudinal cross-sectional view ofFIG.3, the at least one notch210may be in the form of an arcuate-shaped recess within the column section218. However, it is to be appreciated that the implementations of the notch(es)210may comprise a variety of shapes and sizes, such as, but not limited to, notches having triangular or various geometric cross-sections.

In some embodiments, the head portion220of the resilient valve200may not include a notch, but rather may have a discontinuity segment disposed on the column section218. For example, a side or a portion of a side of the column section may be formed of a different material (or a same material with a different hardness value) than the remainder of the column section. Additionally, a side or a portion of a side of the column section may be hollow, while the other side or portion of the remainder of the column section may be solid. Thus, an effective change in the resiliency with respect to the movement of the head (similar to that of a removed or extracted volume of a notch) may result. It is to be understood that while the notches210are shown generally opposite each other on the column section218, other arrangements of the at least one notch210on the column section218, including three or more notches, are contemplated.

According to various embodiments of the present disclosure, the resilient valve200may include any of the various materials used for producing mechanical valves for needleless connectors and other medical implements. In some implementations, the head portion220may include an elastomeric material, such as but not limited to, a silicone compound. Moreover, the primary seal portion225and lower portion230may include an elastomeric material. In some embodiments, all or some of the flexible valve may be formed of liquid silicone rubbers.

Additionally, according to various embodiments, the elastomeric material of the head portion220may have a higher durometer value than the elastomeric material of the lower portion230. For example, the collapsing functionality of the lower portion230associated with facilitating a fluid flow path in the needleless connector100may benefit from a more pliable material or composition attributes for operation, whereas the head portion220and primary seal portion230may require a more rigid construction for disengaging the primary seal225.

In accordance with some embodiments, and referring again toFIGS.1and2, the primary seal portion225may have a cross-sectional area greater than a cross-sectional area of the column section218of the head portion220. For example, the primary seal portion225may be in the form of a frustoconical surface222for engaging with the internal sealing edge122of the connector housing110. The frustoconical shape of the primary seal portion225may be configured such that a first cross-sectional area of the primary seal portion225proximal the head portion220is smaller than a second cross-sectional area of the primary seal portion225distal to the head portion210. In other words, the primary seal portion225may be narrower towards the head portion220and wider towards the lower portion230.

In some embodiments, the lower portion230may be in the form of an elongated tubular member231having a closed end proximal the primary seal portion225and an open end distal the primary seal portion225. As such, an interior air space may be defined in the interior of the resilient valve200. According to some aspects, the resilient valve200may be collapsible in operation with a needleless connector assembly. In these embodiments, the lower portion230may include various dimples and/or incisions to facilitate proper collapsing functionality in accordance with different embodiments of the present disclosure. Moreover, while the head portion220of the resilient valve200may have generally cylindrical properties allowing it to operate with a male luer-tapered tip of a medical implement or similar interconnection device, the lower portion230may be in the form of a plurality of shapes, sizes, and characteristics associated with the functionality and operation of the resilient valve in conjunction with the needleless connector apparatus in which it is used. In some embodiments, when the lower portion230has a tubular section231, this section231may comprise a plurality tubular shapes, such as, but not limited to, cylindrical, rectangular, hexagonal, tubular shapes.

FIG.3is a partial cross-sectional view of the assembled needleless connector100with housing110and compressible valve200ofFIG.1in a closed position before insertion of a medical implement, in accordance with some embodiments of the present disclosure. Referring toFIG.3with continued reference toFIG.1, the assembled needleless connector100as illustrated inFIG.3is in a sealed configuration such that any fluid from an interconnected fluid path coupled to the outlet port123is sealed from the inlet port112. In some embodiments, the needleless connector100may be assembled such that the flange portion240of the compressible valve200is coupled, snapped, or otherwise attached onto a valve mount of the base portion160.

The internal cavity133of the housing110may be arranged on top of the compressible valve200coupled to the base portion160such that the head portion220of the compressible valve200is aligned and disposed within the inlet port112. Upon assembly, the top surface216of the head portion220of the compressible valve200may have a resulting plane that is substantially perpendicular to the central longitudinal axis X2or axial center of the column section218of the head portion220when the head portion220is engaged within the inlet port112of the housing110. Additionally, the one or more internal contact tabs (not shown) disposed on the lower section of the body portion115of the housing110may surround and apply pressure to a sidewall of the flange portion240to secure and/or anchor the compressible valve200in the housing110. In operation, the resilient valve200of the needleless connector can compress, collapse, cant and/or fold when the axial force F (illustrated inFIG.4) is applied to the top surface216of the compressible valve200and 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 (not shown) may provide a radial force substantially orthogonal to the central longitudinal axis X2onto the sidewall of the flange portion240. In this regard, when the axial force F is applied to the top surface216of the head portion220of the compressible valve200, the effect of any resulting axial force through the compressible valve200onto the base portion120of the housing100is reduced if not eliminated. Such a resulting axial force applied onto the base portion120can work against or in derogation, for example, to a fused connection between the base portion120and the body portion115, and over time may disadvantageously cause the fused connection to become breached and/or separated.

FIG.4is a cross-sectional view of a partial cutaway of a housing of a needleless connector having a compressible valve installed therein with an axial force applied to place the valve in an open position, in accordance with some embodiments of the present disclosure.FIG.4provides a longitudinal cross-sectional view of needleless connector100showing the resilient valve200upon initial entry of a medical implement300into the inlet port112. As the medical implement300(e.g., a syringe) is initially inserted into the inlet port112of the needleless connector100, an axial force F is exerted onto the resilient valve200such that the resilient valve is displaced distally causing the frustoconical surface222of the primary seal portion225to separate from the internal sealing edge122.

As the axial force F continues to be applied, the medical implement300may descend further into the inlet port112, the head portion220of valve200may further compress, collapse, cant, and/or fold. As one of the notches210folds or collapses, the other notch210may open or expand such that the top surface216may tilt downwardly (distally) as illustrated inFIG.4). Accordingly, a temporary gap may be formed between the inner surface130of the housing110and the head portion220of the resilient valve200. In this regard, a fluid path from the medical implement300in the inlet port112may be established through the interior of the needleless connector100to the outlet port123. For example, a fluid path may be established between the inlet port112and the outlet port123via the internal cavity133.

As the medical implement50is removed from the first port252, the resilient valve100may begin to expand to return to its position within the housing in the sealed configuration as illustrated inFIG.3. As the resilient valve expands, the circumferential lip seal215engages the inner surface130of the housing110and inverts or otherwise bends thereby acting as a wiper or dam that prevents fluid from moving from the cavity133toward the top surface216of the valve200via the temporary gap. Accordingly, the configuration of the valve member of the various embodiments described herein having the circumferential lip seal215is advantageous as it prevents droplets of fluid from collecting on the top surface216of the valve200by obstructing fluid from moving from cavity133to top surface216via the temporary gap.

Various examples of aspects of the disclosure are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology. Identification of the figures and reference numbers are provided below merely as examples for illustrative purposes, and the clauses are not limited by those identifications.

Clause 1: A valve member for a connector, the valve member comprising: a head portion including a top section defining a first seal portion; a body portion extending longitudinally from the head portion and defining second seal portion at a proximal end thereof, wherein the second seal portion is disposed distally to the first seal portion; and a circumferential lip seal extending radially outward from an outer surface of the head portion, the circumferential lip seal disposed between the first and second seal portions.

Clause 2: The valve member of Clause 1, wherein the circumferential lip seal comprises a flexible member configured to engage an inner surface of the connector and to deflect as the valve member reciprocates within the connector.

Clause 3: The valve member of Clause 1, wherein a distance between the circumferential lip seal and the first seal portion is smaller than a distance between the circumferential lip seal and the second seal portion.

Clause 4: The valve member of Clause 1, wherein a distance that the circumferential lip seal extends radially outward from the outer surface of the head portion is smaller than a distance between the circumferential lip seal and the first seal portion.

Clause 5: The valve member of Clause 1, wherein the top section includes a top planar surface and the circumferential lip seal is oriented parallel to the top planar surface.

Clause 6: The valve member of Clause 1, wherein the top section includes a top planar surface and the circumferential lip seal is oriented at a non-parallel angle with respect to the top planar surface.

Clause 7: The valve member of Clause 1, wherein the head portion further comprises a column section defining an axial center of the head portion, and the circumferential lip seal is oriented substantially perpendicularly with respect to the axial center of the head portion.

Clause 8: The valve member of Clause 1, wherein the head portion further comprises a column section defining an axial center of the head portion, and the circumferential lip seal is oriented at a non-perpendicular angle with respect to the axial center of the head portion.

Clause 9: The valve member of Clause 1, wherein the head portion further comprises a column section defining an axial center of the head portion, the column section further defining at least one notch disposed along the outer surface of the head portion.

Clause 10: The valve member of Clause 1, wherein at least one of the head portion or the circumferential lip seal comprises an elastomeric material.

Clause 11: The valve member of Clause 1, wherein the circumferential lip seal comprises silicone or a silicone compound.

Clause 12: A needleless connector, comprising: a housing having 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; and a resilient valve disposed within at least a portion of the internal cavity and movably retained within the housing, the resilient valve comprising: a head portion including a top section and a body portion extending distally from the head portion; and a circumferential lip seal extending radially outward from an outer surface of the head portion and disposed between the top section and the body portion, wherein in an open state of the resilient valve where a gap exists between the inner surface of the housing and the outer surface of the head portion, the circumferential lip seal engages at least a portion of the inner surface of the housing to obstruct fluid from flowing from the internal cavity towards and onto the top section of the head portion.

Clause 13: The needleless connector of Clause 12, wherein the body portion of defines a primary seal portion at a proximal end thereof, the top section of the head portion defines a secondary seal portion, and the circumferential lip seal comprises a seal positioned between the primary and secondary seal portions.

Clause 14: The needleless connector of Clause 13, wherein a distance between the circumferential lip seal and the secondary seal portion is smaller than a distance between the circumferential lip seal and the primary seal portion.

Clause 15: The needleless connector of Clause 13, wherein a distance that the circumferential lip seal extends radially outward from the outer surface of the head portion is smaller than a distance between the circumferential lip seal and the secondary seal portion.

Clause 16: The needleless connector of Clause 12, wherein a diameter of the circumferential lip seal is greater than a diameter of the inner surface at the inlet port.

Clause 17: The needleless connector of Clause 16, wherein the circumferential lip seal comprises a flexible member which engages the inner surface of the housing at the inlet port to deflect to an inverted shape as the valve member reciprocates within the housing between the open state and a closed state.

Clause 18: The needleless connector of Clause 12, wherein the top section includes a top planar surface and the circumferential lip seal is oriented parallel to the top planar surface.

Clause 19: The needleless connector of Clause 12, wherein the top section includes a top planar surface and the circumferential lip seal is oriented at a non-parallel angle with respect to the top planar surface.

Clause 20: The needleless connector of Clause 12, wherein the head portion further comprises a column section defining an axial center of the head portion, and the circumferential lip seal is oriented substantially perpendicularly with respect to the axial center of the head portion.

Clause 21: The needleless connector of Clause 12, wherein the head portion further comprises a column section defining an axial center of the head portion, and the circumferential lip seal is oriented at a non-perpendicular angle with respect to the axial center of the head portion.

It is understood that the specific order or hierarchy of steps, or operations in the processes or methods disclosed are illustrations of exemplary approaches. Based upon implementation preferences or scenarios, it is understood that the specific order or hierarchy of steps, operations or processes may be rearranged. Some of the steps, operations or processes may be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations, or processes may be performed automatically, without the intervention of a user. The accompanying method claims present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.