NEEDLELESS CONNECTOR WITH FOLDING VALVE

A needleless connector has a body having an internal cavity with a sealing ridge, a port, an output flow channel, and a fluid flow path between the port and output flow channel. The connector also has a collapsible valve disposed within the cavity. The valve includes a cylindrical wall having a center axis and a shoulder and defining an internal air space, wherein the shoulder is configured to sealingly contact the ridge of the body so as to block the fluid flow path, and a head fixedly attached to the wall, the head having first and second smiley cuts disposed on opposite sides of the head.

DETAILED DESCRIPTION

It is advantageous to provide a self-sealing, needleless connector that accepts male Luer fittings that meet the ISO standard while the size of the connector, and therefore the volume of fluid within the connector, is reduced compared to conventional connectors.

In the following detailed description, numerous specific details are set forth to provide a full understanding of the present disclosure. It will be apparent, however, to one ordinarily skilled in the art that embodiments of the present disclosure may be practiced without some of the specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the disclosure. In the referenced drawings, like numbered elements are the same or essentially similar. Reference numbers may have letter suffixes appended to indicate separate instances of a common element while being referred to generically by the same number without a suffix letter.

FIGS. 1A-1Bare cross-sections of a conventional needleless connector10. With reference toFIG. 1A, the connector10includes a collapsible valve20disposed within a cavity51of body50. The valve20has a shoulder30that continuously contacts a ridge54within the cavity51when the connector10is de-activated, i.e. not connected to a mating connector, to form a primary seal that blocks the fluid flow path through the connector10. The valve20has an internal air space32that is separated from the cavity51by a cylindrical wall28. The air space32is vented to the ambient environment through air passages56and the external cavity58within the threaded connector38surrounding the male Luer fitting39of the body50, as indicated by the air flow path70. The valve20also has a solid head22with a “smiley cut”26formed on one side and a top surface24that is positioned generally flush with a port52of the cavity51when the connector10is de-activated. The edge of the top surface24seals to the port52. The top surface24is continuous, i.e. there is no slit or penetration in the surface that may trap bacteria or other contamination. The conventional connector10has a representative overall length of L1. In certain conventional valves, L1=1.324 inches.

FIG. 1Bdepicts the valve10in the activated position, i.e. a male Luer fitting2sealingly coupled to the connector10at port52. The tip of the male Luer fitting2has displaced the external surface24downward and the applied force has caused the head22to buckle toward the smiley cut26as well as causing the cylindrical wall28to buckle. Two external dimples40(indicated in phantom) are located on an exterior surface (not visible in the cross-section ofFIG. 1B) of the wall28. The dimples40control the collapse of the wall28to occur at a predictable level of force. In the activated configuration, the primary seal between the shoulder30and ridge54is opened such that fluid may flow through the connector10, as indicated by the fluid flow path80that passes from the lumen3of the male Luer fitting2through the cavity51and through channels62in the base and out through an output flow channel64of the male fitting39that is fluidly coupled to the flow channel5of the connected female Luer fitting4. Air passes out of the air chamber32along the air flow path70as the valve20collapses.

While the conventional needleless connector10ofFIGS. 1A,1B allows the connection and disconnection of a male Luer fitting and seals the flow path when there is no fitting mated with the connector10, it is generally desirable to have the least possible amount of fluid contained in the needleless connector. To this end, the disclosed needleless connector100provides the same functionality of allowing the connection and disconnection of the same male Luer fitting and sealing of the flow path when there is no fitting mated, with the improvement of a smaller body that results in a smaller internal volume of fluid compared to the conventional connector10. As a medication that remains trapped in the connector may not reach a patient, unless the connector is flushed with a medical liquid such as a saline solution, reducing the liquid volume of a needleless connector increases the amount of the medication that reaches the patient. In addition, as medications may degrade over time and connectors may not always be flushed after administration of the medication through a needleless connector, a reduction in the trapped volume of a medication in a connector necessarily reduces the amount of degraded medication that may reach the patient at a later time.

FIGS. 2A-2Bare cross-sections of an exemplary needleless connector100according to certain aspects of the present disclosure. The connector100has a body150that defines a cavity151. The connector100has a characteristic length L2, which references the same features as the characteristic length L1, this is less than L1. In certain embodiments, L2 is less than 90% of L1. In certain embodiments, L2=1.200 inches. The smaller body150contains less fluid than the body50of the conventional connector10. The body150of the connector100is generally similar to the body150of connector, although the port152and the male Luer fitting139meet the same ISO standards as port52and fitting39of connector10. In certain embodiments, the male Luer fitting139may be replaced with a tubing connector (not shown) that accepts an end of a length of tubing, for example when a connector100is integrated into an IV set.

As the size of the connector100is reduced compared to connector10, the volume of the cavity151that is external to the valve120is also reduced compared to connector10. As the wall thickness of the body150and some internal features must remain the same as body50, for example to provide a minimum thickness for flow of molten plastic in a molding process, the reduction in the fluid volume may be proportionately greater than the reduction in a linear dimension. In certain embodiments, the reduction in fluid volume may be 40% while the reduction in the linear dimension L2 vs. L1 may be only 10%.

The connector100has a valve120disposed within the cavity151that is generally similar to the valve20of connector10. The valve120comprises a flexible material, for example silicone. Valve120has a center axis101and a head122with two smiley cuts126,128disposed on opposite sides of the head. The details of the smiley cuts are discussed in greater detail inFIGS. 3-5.

FIGS. 3-5are cross-sections of various example embodiments of a valve according to certain aspects of the present disclosure.FIG. 3depicts the head222of a valve200that is similar to valve120ofFIG. 2. The valve200has two identical smiley cuts210that are equally spaced from a center axis201of the valve200and have a common depth D2. The smiley cuts210have a uniform profile, i.e. the shape is the same over the length of the smiley cut, through the head222. InFIG. 3, the directions of length, width, and depth of the smiley cuts are shown by the coordinate legend inFIG. 3, wherein the curved arrow indicates that length “L” is defined as directed into the plane of the drawing. The length of a smiley cut is defined as the value of the uniform profile in the direction of length L as measured at the maximum depth D. In certain embodiments, the depth D2 is defined at the center of the profile. In certain embodiments, the profile is symmetric. In certain embodiments, the profile is not symmetric. In certain embodiments, the profile has a constant radius. In certain embodiments, the profile has a variable radius. In certain embodiments, D2 is less than or equal to 30% of a diameter D1 of the head222. In certain embodiments, D2 is less than or equal to 25% of D1. In certain embodiments, D1=0.150 inches. In certain embodiments, D2=0.038 inches.

FIG. 4depicts the head322of a valve300that is similar to valve120ofFIG. 2. The valve300has smiley cuts310,315that are disposed on opposite sides of head322with depths D3, D4 respectively. In certain embodiments, D3 is equal to or greater than 30% of D1 while D4 is less than or equal to 25% of D1. In this example, smiley cut315is axially offset along the center axis301from smiley cut310. In this example, the smiley cuts310,315each have a parabolic profile, wherein the profile of smiley cut310is not the same profile as smiley cut315. In certain embodiments, D3 and D4 are equal while smiley cuts310,315have different parabolic profiles such that the respective widths W3, W4 of the smiley cuts310,315are not equal. In certain embodiments W3 and W4 are equal.

FIG. 5depicts the head422of a valve400that is similar to valve120ofFIG. 2. The valve400has smiley cuts410,412that are disposed on opposite sides of head422. In this example, smiley cuts410,412are axially aligned with different depths D5, D6. In certain embodiments, D5 is equal to or greater than 50% of D1. In certain embodiments, D6 is less than or equal to 20% of D1. In this example, smiley cut410has a parabolic profile while smiley cut412has a constant radius profile.

It can be seen that the disclosed embodiments of the needleless connector have a reduced internal volume of fluid while providing a self-sealing connection port of the same size and configuration of a conventional needleless connector. This reduction in fluid volume reduces the amount of fluid that remains trapped in the disclosed needleless connector when a connector attached to an IV line or a container such as a syringe is disconnected from the connector. While some amount of fluid is unavoidably retained in any needleless connector, reducing the amount of fluid that remains trapped in a connector increases the amount of an administered medication that reaches the patient. In addition, as medications may degrade over time, a reduction in the trapped volume of a medication in a connector necessarily reduces the amount of degraded medication that may reach the patient at a later time.

A phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as an “embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. A phrase such an embodiment may refer to one or more embodiments and vice versa.