Patent Description:
Connectors used with drug delivery devices typically share a common ISO standard luer connection. A standard luer tip or standard male connector has specifications as provided by the International Organization for Standardization (ISO) in ISO <NUM>-<NUM>:<NUM> and <NUM>-<NUM>:<NUM>, including a <NUM>% taper that increases from the open distal end to the proximal end and an outer cross-sectional diameter at the distal end of the tip measuring between about <NUM> inches (<NUM>) and about <NUM> inches (<NUM>) for rigid material and between about <NUM> inches (<NUM>) and about <NUM> inches (<NUM>) for semi-rigid material. A standard luer hub or standard female luer connector may have a <NUM>% taper that decreases from the open proximal end to the distal end and an inner cross-sectional dimension at the open proximal end measuring between about <NUM> inches (<NUM>) to about <NUM> inches (<NUM>). In embodiments of standard female luer connectors that incorporate tabs or lugs for connection to a corresponding male luer lock connector, the outer cross-sectional dimension of the standard female luer connector, including the lugs, is in the range from about <NUM> inches (<NUM>) to about <NUM> inches (<NUM>). In embodiments of standard female luer connectors that do not incorporate tabs or lugs for connection to a corresponding male luer lock connector, the outer cross-sectional dimension may be about <NUM> inches (<NUM>) for rigid connectors and about <NUM> inches (<NUM>) for semi-rigid connectors, based on the maximum outside diameter of the standard female luer connector at the base of the lugs of ISO <NUM>-<NUM>. The minimum length of the standard luer tip and/or the standard luer hub is <NUM> inches (<NUM>), according to ISO <NUM>-<NUM>. As used herein, the phrases "standard male luer connector" and "standard female luer connector" shall refer to connectors having the above dimensions.

Standard luer male connectors and standard female connectors, collectively referred to herein as standard luer connectors, may be used in intravascular, anesthesia and enteral delivery systems and may include structure that allows a drug delivery device for one system to be to be compatible with other systems. For example, some neuraxial drug delivery systems may use the same type of standard luer connector as the connectors used with other delivery applications, for example, central intravenous catheters, central venous pressure parts, infusion ports, balloon ports, introducer ports, IV luer connectors, peritoneal dialysis catheters, distal port for a pulmonary artery catheter, and many other connectors. An unintended consequence of connecting a drug delivery system for one type of delivery system to connectors for use with other types of delivery systems is that such connection would provide a link between two unrelated systems, i.e., neuraxial to intravenous (IV). Each delivery system is intended to provide unique methods of delivery, with distinctly different purposes and different medications, which the interchangeability of known drug delivery systems can circumvent. Such circumvention can lead to harm and/or serious injury to the patient.

Limiting the use of standard luer connectors for vascular access or systems is one consensus accepted by device manufacturers and regulatory bodies. Accordingly, there has been a need to modify all other devices so they have a different type of connector that cannot physically connect with a standard luer connector or incompatible devices. New proposed standards for small bore connectors, for example ISO <NUM>-<NUM> for neuraxial applications, have also propelled the need for suitable non-luer connectors. These new proposed standards include connectors with a <NUM>% taper, instead of a <NUM>% taper that is currently used with standard luer connectors. In addition, the new standards propose connectors with smaller inner and outer cross-sectional dimensions and longer lengths than standard luer connectors.

Attempts to prevent or minimize misconnections between drug delivery systems include educating practitioners about misconnections, labeling and color-coding. However, these attempts offer only temporary solutions. The use of adapters which provide a removable non-luer adapter also does not provide a permanent solution that is free of or reduces human error. Other solutions require the use of adapters to enable users to fill the medication to be administered into the drug delivery system because the drug delivery system is not compatible with standard ampoules, vials or other containers.

There is a need for non-luer connectors for use with drug delivery systems that prevent misconnection with standard luer connectors and other unintended drug delivery systems.

<CIT> teaches a connector according to the preamble of claim <NUM>.

In this disclosure, a convention is followed wherein the distal end of the device is the end closest to a patient and the proximal end of the device is the end away from the patient and closest to a practitioner.

As used herein, the term "dimension" shall include the length, diameter or width of a geometric shape or the geometrically shaped components described herein. The term "cross-sectional dimension" shall include the measurement of the longest distance or greatest distance between two points on an edge of a cross-section of an object or component with a circular or non-circular cross-section. The two points may be located on the inside surface or outside surface of the edge of the cross-section of the object. The cross-sectional dimension of two points located on the inside surface of the edge of the cross-section of the object shall be referred to as the "inside cross-sectional dimension" and the cross-sectional dimension of two points located on the outside surface of the edge of the cross-section of an object shall be referred to as the "outside cross-sectional dimension. " It should be recognized that "cross-sectional dimension" of objects having a circular cross-section may be referred to as the "diameter" of the object. The terms "cross-sectional dimension" and "diameter" may be used interchangeably for objects having a circular cross-section.

While the present invention is defined in independent claim <NUM>, the drug delivery systems of one or more examples described herein may be used for neuraxial, anesthesia, intravascular or other drug delivery applications.

A first aspect of the present disclosure pertains to a non-luer connector for connection to a second non-luer connector. In one or more embodiments, the non-luer connector includes a container including an open distal end including a distal wall and a sidewall extending in a proximal direction from the distal wall. The sidewall includes an inside surface defining a fluid chamber for retaining fluids. The container also includes an elongate tip extending in a distal direction from the distal wall. The elongate tip includes an opening providing access to the chamber, an outside surface and a distal end.

In one or more embodiments, the outside surface of the elongate tip includes an outer cross-sectional dimension measured at the distal end of the tip of <NUM> inches or less. In one or more specific embodiments, the outer cross-sectional dimension of the elongate tip measured at the distal end of the tip is in the range from about <NUM> inches to about <NUM> inches. In an even more specific embodiment, the outer cross-sectional dimension of the elongate tip measured at the distal end of the elongate tip is in the range from about <NUM> inches to about <NUM> inches.

The elongate tip of one or more embodiments may have a length, measured from the distal wall of the container to the distal end of the elongate tip in the range from about <NUM> inches to about <NUM> inches.

The outside surface of the elongate tip may have a taper of less than <NUM>% that decreases in a proximal to distal direction. In one or more specific embodiments, the taper of the outside surface may be in the range from about <NUM>% to about <NUM>%.

In one or more embodiments, the outside surface of the elongate tip may have a taper of more than <NUM>% that decreases in a proximal to distal direction.

The non-luer connector of one or more embodiments may further include a female non-luer connector that is removably attached to the elongate tip of the container. In one or more embodiments, the female non-luer connector includes a hub body with an open proximal end and an interior surface defining a cavity. The hub body may optionally include a needle cannula attached thereto. The needle cannula may include an open proximal end in fluid communication with the opening of the container.

In one or more embodiments, the cavity of the hub body may have an inner cross-sectional dimension measured at the open proximal end of less than <NUM> inches, measured at the open proximal end. In one or more specific embodiments, the cavity of the hub body may have an inner cross-sectional dimension at a proximal end in the range from about <NUM> inches to about <NUM> inches. In an even more specific embodiment, the cavity of the hub body has an inner cross-sectional dimension measured at the open proximal end in the range from about <NUM> inches to about <NUM> inches.

The cavity of one or more embodiments of the female non-luer connector may have a length in the range from about <NUM> inches to about <NUM> inches.

In one or more embodiments, the interior surface of the cavity has taper of less than <NUM>% decreasing in a proximal to distal direction. In one or more specific embodiments, the interior surface of the cavity has a taper decreasing in a proximal to distal direction in the range from about <NUM>% to about <NUM>%, or alternatively, in the range from about <NUM>% to about <NUM>%.

In one or more embodiments, the interior surface of the cavity has taper of more than <NUM>% decreasing in a proximal to distal direction.

In one or more embodiments, the elongate tip of the container may include a square cross-sectional shape. In one or more specific embodiments, the outside surface of the elongate tip may include a square cross-sectional shape. The cavity of the female non-luer connector of one or more embodiments may have an interior surface having a square cross-sectional shape. The female non-luer connector may also have an inner cross-sectional dimension selected to form a fluid-tight seal with the elongate tip, or more specifically, the outside surface of the elongate tip. In one or more alternative embodiments, the elongate tip may have a circular cross-sectional shape. The cavity of the female non-luer connector may have an inner cross-sectional dimension selected to form a fluid-tight seal with the elongate tip. Specifically, the shape and/or size of the inner cross-sectional dimension of the cavity may be selected to form a fluid-tight seal with the outside surface of the elongate tip.

A second aspect of the present disclosure pertains to a non-luer connector for connection to a female non-luer connector that includes a non-luer element. In one or more embodiments, the non-luer connector includes a container having an open distal end including a distal wall and a sidewall that extends in a proximal direction from the distal wall. The sidewall may include an inside surface that defines a fluid chamber for retaining fluids. The container may also include an elongate tip that extends in a distal direction from the distal wall. The elongate tip includes an opening for providing access to the chamber. In one or more embodiments, a non-luer element is disposed at the open distal end of the container for preventing fluid-tight connection of a standard luer connector to the container.

In one or more embodiments, the elongate tip includes an outside surface on which the non-luer element may be disposed. The non-luer element of one or more variants may include an exterior surface with an outer cross-sectional dimension that is greater than the outer cross-sectional dimension of the elongate tip. The outer cross-sectional dimension of the non-luer element may also be greater than an inner cross-sectional dimension of a standard female luer connector. The outer cross-sectional dimension of the non-luer element may prevent connection of a standard female luer connector to the elongate tip. In one or more alternative embodiments, the exterior surface of the non-luer element has one of a circular cross-sectional shape, a square cross-sectional shape and a triangular cross-sectional shape.

Embodiments of the non-luer connector according to the second aspect may include a female non-luer connector being removably attached to the elongate tip of the container, as otherwise described herein. In one or more embodiments, the female non-luer connector may have a cavity with cross-sectional dimension selected to form a fluid-tight seal with the elongate tip or, more specifically, with the outside surface of the tip.

In one or more embodiments, the non-luer element extends in a distal direction from the distal wall of the container. The non-luer element may be disposed coaxially around the elongate tip and form a channel between the elongate tip and the non-luer element for receiving a portion of a female non-luer connector. In one or more variants, the inner cross-sectional dimension of the non-luer element may be greater than an inner cross-sectional dimension of a standard female luer connector and less than an outer cross-sectional dimension of the standard female luer connector. In one or more alternative embodiments, the non-luer element has one of a circular cross-section, a square cross-section and a triangular cross-section. The non-luer element according to the present invention includes at least one aperture that provides access to the channel. In one variant, the non-luer element includes at least two apertures and includes a curved cross-sectional shape between the two apertures. In another variant, the non-luer element includes a distal end and a proximal end and the at least one or two apertures extends from the distal end to the proximal end of the non-luer element. In yet another variant, the at least one or two apertures extends from the distal end to a distance partially between the distal end and the proximal end of the non-luer element. The aperture or apertures provided in one or more embodiments may provide visual indication of whether the non-luer connector comprises a luer slip fitting or a luer lock fitting. The non-luer connector of one or more embodiments may incorporate an at least one aperture that has a dimension selected to prevent formation of a fluid-tight seal between the non-luer element and a standard female luer connector. In one variant, the distal end of the non-luer element extends distally past the elongate tip. In another variant, the elongate tip includes a distal end that extends distally past the distal end of the non-luer connector.

In one or more embodiments in which the non-luer element is disposed coaxially around the elongate tip, the non-luer connector may include a female non-luer connector removably attached to the elongate tip of the container, as described herein. In one or more embodiments, the female non-luer connector may include a hub body and a cavity dimensioned for fluid-tight connection of the female non-luer connector to the elongate tip. In one or more embodiments, the cavity of the female non-luer connector may have a cross-sectional dimension selected to form a fluid-tight seal with the elongate tip.

In one or more embodiments, the non-luer element may be provided on the non-luer connector at a distal end of the elongate tip. The non-luer element may be disposed at the distal end of the elongate tip for preventing the formation of a fluid tight seal between the elongate tip and a standard female luer connector. In one or more embodiments, the elongate tip may include a body wall with an outside surface extending from the distal end to the distal wall of the container and the non-luer element includes a notch in fluid communication with the opening of the elongate tip for extending the opening across the distal end of the elongate tip to the outside surface of the body wall of the elongate tip. In one or more specific embodiments, the non-luer element includes a plurality of notches disposed on the distal end of the elongate tip. The plurality of notches may be disposed adjacent to one another along the circumference of the distal end of the tip and may surround the opening of the tip. In one or more variants, the plurality of notches having a wedge shape that extends into the distal end of the elongate tip. The length of the elongate tip may vary along the plurality of notches. Specifically, the elongate tip may have a length that increases along the distal end from the opening of the tip to the outside surface of the tip. In one or more embodiments, the outside surface of the elongate tip has a taper of <NUM>% decreasing in a proximal to distal direction. The tip may also have an outer cross-sectional dimension sized to prevent connection of a standard female luer connector to the container.

Embodiments of the non-luer connector that includes a notch, notches or a plurality of notches may include a female non-luer connector being removably attached to the elongate tip, as otherwise described above. The female non-luer connector may include an interior surface defining a cavity dimensioned for fluid-tight connection of the female non-luer connector to the elongate tip. In one or more embodiments, upon attachment of the female non-luer connector to the container, the notch may be in contact with the interior surface of the hub body and a fluid-tight seal is formed between the distal end of the elongate tip and the female non-luer connector. In one or more alternative embodiments, upon attachment of a standard female luer connector to the container, the notch is disposed at a distance from an inside surface of the standard female luer connector, preventing formation of a fluid-tight seal between the distal end of the elongate tip and the standard female luer connector. The interior surface of the female non-luer connector may have a <NUM>% taper that decreases in a proximal to distal direction. According to the present invention, the non-luer element further includes at least one aperture that provides access to the channel.

A third aspect of the present disclosure pertains to a drug delivery device that includes a container and a female non-luer connector. In one or more embodiments, the container includes an open distal end including a distal wall and a sidewall extending in the proximal direction from the distal wall. The sidewall includes an inside surface defining a fluid chamber for retaining fluids. An elongate tip is disposed on the distal wall and extends in a distal direction from the distal wall. The elongate tip includes an opening for providing access to the chamber and an inside surface including a taper of less than <NUM>% decreasing in a proximal to distal direction. The elongate tip may have an outer cross-sectional dimension sized to prevent connection of a standard female luer connector to the container. The female non-luer connector may include a hub body including an open proximal end and an interior surface defining a cavity. The interior surface of the hub body may have a taper of less than <NUM>% decreasing in a proximal to distal direction. The cavity may have an inner cross-sectional dimension that is sized to prevent connection of the female non-luer connector to a standard female luer connector. The hub body may optionally include a needle cannula attached to the hub body that includes an open distal end in fluid communication with the opening of the container.

The drug delivery device of one or more embodiments may include a visual indicator for providing indication that a fluid-tight seal is formed between the female non-luer connector and the container and the needle cannula is in fluid communication with the opening of the container.

Aspects of the present disclosure pertain to non-luer connectors that prevent misconnection to other incompatible or unintended standard luer connectors. A non-luer connector shall be defined herein as a connector that has a shape, dimension or structure that differs from standard luer connectors, as defined above. A non-luer connector shall also include a connector that has a shape, dimension or structure that prevents it from being characterized or defined as a luer connector as defined above or according ISO <NUM>-<NUM>:<NUM> or ISO <NUM>-<NUM>:<NUM>. In one or more specific embodiments, a non-luer connector has a length and/or cross-sectional dimension that differs from a luer connector as defined above or according ISO <NUM>-<NUM>:<NUM> or ISO <NUM>-<NUM>:<NUM>. In a more specific embodiment, a non-luer connector has a taper that differs from a luer connector as defined above or according ISO <NUM>-<NUM>:<NUM> or ISO <NUM>-<NUM>:<NUM>. In an even more specific embodiment, a non-luer connector has a more gentle taper than a luer connector as defined above or according ISO <NUM>-<NUM>:<NUM> or ISO <NUM>-<NUM>:<NUM>, a cross-sectional dimension that is smaller than a luer connector as defined above or according ISO <NUM>-<NUM>:<NUM> or ISO <NUM>-<NUM>:<NUM> and a longer length than a luer connector as defined above or according ISO <NUM>-<NUM>:<NUM> or ISO <NUM>-<NUM>:<NUM>. Specifically, the embodiments of the non-luer connectors described herein incorporate features that prevent connection of standard luer connectors to the non-luer connectors. Standard luer connectors, as used herein, may include needle hubs, syringes or other delivery components that incorporate a standard luer connector. Exemplary standard luer connectors are shown in <FIG>. <FIG> illustrates a syringe barrel <NUM> having distal end <NUM> and a proximal end <NUM>. The syringe barrel <NUM> includes a sidewall <NUM> that extends from the distal end <NUM> to the proximal end <NUM> and includes an inside surface <NUM> defining a chamber <NUM> for retaining fluids. The syringe barrel <NUM> also includes a distal wall <NUM> adjacent to the distal end <NUM> and a flange <NUM> disposed at the proximal end <NUM> of the syringe barrel. A luer connector <NUM> is provided in the form of an open tip <NUM> that extends from the distal wall <NUM> and includes a passageway <NUM> in fluid communication with the chamber <NUM>. The tip <NUM> includes an outside surface <NUM> that defines an outer cross-sectional dimension and length that is typical of standard male luer connectors.

An exemplary standard needle hub <NUM> having a standard female luer connector is shown in <FIG>. The needle hub <NUM> includes an open distal end <NUM> and an open proximal end <NUM>. A hub body <NUM> extends from the distal end <NUM> to the proximal end <NUM>. In the embodiment shown, the luer connector <NUM> is provided in the form of a hub body <NUM> that includes an inside surface <NUM> defining a cavity <NUM>. The cavity <NUM> is sized and has a shape to permit fluid-tight engagement with the tip <NUM> of the syringe barrel. The needle hub <NUM> shown in <FIG> also includes a needle cannula <NUM> attached to the open distal end <NUM>. The needle cannula <NUM> includes an open distal end <NUM> in fluid communication with the cavity <NUM>. The inside surface <NUM> of the hub body <NUM> has an inner cross-sectional dimension and length that is typical of standard female luer connectors.

Both of the standard luer connectors of the syringe barrel <NUM> and the needle hub <NUM> are sized and shaped form an interference fit connection and/or fluid-tight engagement with each other. Specifically, the outside surface of the tip <NUM> has a taper, length and shape that is typical of standard male luer connectors, as described above, that permits the tip <NUM> to form an interference fit connection with the inside surface of the needle hub <NUM>, which also has a taper, length and shape that is typical of standard female luer connectors, as also described above. In one or more alternative embodiments, the syringe barrel <NUM> may include a standard male luer connector in the form of a luer lock connector (not shown), which includes a threaded portion that engages a cooperating structure of the needle hub <NUM>, for example, as shown in <FIG>, the outwardly extending tab <NUM>, to attach the needle hub <NUM> to the syringe barrel <NUM>.

A first aspect of the present disclosure pertains to non-luer connectors which have a dimension and/or shape or incorporate a feature that prevent connection of the non-luer connectors to standard luer connectors. A second aspect of the present disclosure includes non-luer connectors that utilize a non-luer element to prevent connection to standard luer connectors. A third aspect of the present disclosure includes non-luer connectors that prevent the formation of a fluid-tight connection between the non-luer connectors and a standard luer connector thereby causing leakage or increasing the possibility of leakage of liquid at the connection.

One or more embodiments of a female non-luer connector <NUM> are shown in <FIG> that may be utilized as part of the drug delivery devices according to the first aspect, second aspect and the third aspects of the present disclosure. Specifically, the female non-luer connector <NUM> includes a non-luer portion <NUM> that may be connected to a non-luer connector of the containers that will be described below.

The female non-luer connector <NUM> includes an open distal end <NUM> and an open proximal end <NUM>. The female non-luer connector <NUM> also includes a non-luer portion <NUM> for forming an interference fit connection with a corresponding non-luer connector. The non-luer portion <NUM> is an integral component of the female non-luer connector <NUM> and is provided in the embodiment shown in <FIG> as a wall <NUM> that extends distally from the open proximal end <NUM> of the female non-luer connector <NUM>. The wall <NUM> includes an inside surface <NUM> defining a cavity <NUM> for receiving at least a portion of a corresponding non-luer connector. The female non-luer connector <NUM> includes an outside surface <NUM> with a radially outwardly extending rim <NUM> is disposed along the entire circumference of the outside surface <NUM> at the distal end <NUM> of the female non-luer connector <NUM>. The rim <NUM> in the embodiment shown in <FIG> includes a radially outwardly extending tab <NUM> disposed along at least a portion of the rim <NUM> for engaging corresponding non-luer connectors with a locking feature or threaded component. The tab <NUM> may include two tapered ends for facilitating engagement with the locking feature or threaded component. The rim <NUM> includes an inside surface <NUM> that has a cross-sectional diameter that is greater than the cross-sectional diameter of the remainder of the female non-luer connector <NUM>.

The inside surface <NUM> of the wall <NUM> that has a dimension and/or shape that enables engagement or attachment of the female non-luer connector <NUM> with other corresponding non-luer connectors. As will be described below, corresponding non-luer connectors include an outside surface with an outer cross-sectional dimension that is smaller or larger than the inner cross-sectional dimension measured at the inside surface <NUM> of standard female luer connectors. The outer cross-sectional dimension of the corresponding non-luer connectors, however, is sized and/or shaped to properly engage the inside surface <NUM> of the female non-luer connector <NUM> shown in <FIG> to produce a fluid-tight connection.

In one or more embodiments, the inside surface <NUM> of the wall <NUM> may be shaped to form a fluid-tight engagement with a corresponding non-luer connector having a non-circular cross-section. Specifically, the inside surface <NUM> of the wall <NUM> may have a square, triangular or other non-circular cross-section that permits the formation of an interference fit connection and/or fluid-tight engagement with a non-luer connector with an outside surface having a square, triangular or other non-circular cross-section.

In addition, the inside surface <NUM> of the wall <NUM> has a dimension and/or shape that prevents engagement of the female non-luer connector <NUM> to a standard male luer connector. Specifically, the inside surface <NUM> of the wall <NUM> may have a square, triangular or other non-circular cross-section that prevents the formation of an interference fit connection and/or fluid-tight engagement with a standard male luer connector, for example, the tip <NUM> having an outside surface <NUM> with a circular cross-section. In embodiments where the inner cross-sectional dimension of the wall <NUM> is sized to permit the tip <NUM> or standard male connector of a typical luer connector to be disposed within the cavity <NUM>, the non-circular cross-sectional shape of the wall <NUM> at the inside surface <NUM> prevents sufficient contact between the outside surface <NUM> of the tip and, thereby, prevents formation of an interference fit connection and/or fluid-tight engagement there between. In one or more embodiments, the inner cross-sectional dimension of the wall <NUM> may be greater than the outer cross-sectional dimension of the tip <NUM> or other standard male luer connector, which also prevents sufficient contact between the outside surface <NUM> of the tip or other luer connector and, thereby, prevents formation of an interference fit connection and/or fluid-tight engagement there between.

In the embodiment shown, the attachment end <NUM> also includes a first narrowed wall <NUM> extending from the wall <NUM> to a second narrowed wall <NUM> disposed distally adjacent to the first narrowed wall <NUM>. A third narrowed wall <NUM> is disposed distally adjacent to the second narrowed wall <NUM> and extends to the proximal end <NUM> of the female non-luer connector <NUM>. The inner cross-sectional dimension of the first narrowed wall <NUM> is less than the inner cross-sectional dimension of the wall <NUM> measured at its inside surface. The first narrowed wall <NUM> may have a taper or an inner cross-sectional dimension that decreases in the distal direction. The inner cross-sectional dimension or shape of the first narrowed wall <NUM> may also prevent attachment of the female non-luer connector <NUM> to a standard male luer connector.

The second narrowed wall <NUM> has an inner cross-sectional dimension that is less than the inner cross-sectional dimension of the first narrowed wall <NUM> and the inner cross-sectional dimension of the wall <NUM>. As shown in <FIG>, the second narrowed wall <NUM> may have a taper wherein its inner cross-sectional dimension decreases in the distal direction. In the embodiment shown in <FIG>, the taper or decrease in the inner cross-sectional dimension of the second narrowed wall <NUM> is severe or drastic. In one or more alternative embodiments, the taper or decrease in the inner cross-sectional dimension of the second narrowed wall <NUM> may be gradual and/or the second narrowed portion may have a constant inner cross-sectional dimension. The third narrowed wall <NUM> has an inner cross-sectional dimension that is less than the inner cross-sectional dimensions of the wall <NUM>, the first narrowed wall <NUM> and the second narrowed wall <NUM>. The third narrowed wall <NUM> may have a constant inner cross-sectional dimension or, as shown in <FIG>, include a proximal portion with a tapered inner cross-sectional dimension that decreases in the distal direction and a distal portion with a constant inner cross-sectional dimension. The third narrowed wall <NUM> is shaped and sized to support a needle cannula within the cavity <NUM>, which extends from the open proximal end <NUM> of the female non-luer connector to the open distal end of the hub, including from the wall <NUM> to the third narrowed wall <NUM>.

In one or more embodiments, the cavity <NUM> has an inner cross-sectional dimension measured at the proximal end <NUM> of less than <NUM> inches. In one or more specific embodiments, the cavity <NUM> has an inner cross-section dimension measured at the proximal end <NUM> in the range from about <NUM> inches to about <NUM> inches, or more specifically in the range from about <NUM> inches to about <NUM> inches. In an even more specific embodiment, the cavity <NUM> has an inner cross-section dimension measured at the proximal end <NUM> in the range from about <NUM> inches to about <NUM> inches. The lower limit of the inner cross-sectional dimension of the cavity <NUM> at the proximal end <NUM> may include <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches. The upper limit of the inner cross-sectional dimension of the cavity <NUM> at the proximal end <NUM> may include <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches. In one or more embodiments, the inner cross-sectional dimension of the cavity <NUM> may be in the range from about <NUM> inches to <NUM> inches, from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, or from about <NUM> inches to about <NUM> inches.

In one or more embodiments, the inside surface <NUM> of the wall <NUM> may have a taper of less than <NUM>% decreasing in a proximal to distal direction or an inner cross-section dimension that decreases from the proximal end <NUM> toward the distal end <NUM> at a rate of less than <NUM>%. In one or more specific embodiments, the inside surface <NUM> of the wall <NUM> has a taper decreasing in a proximal to distal direction in the range from about <NUM>% to about <NUM>%. In one or more embodiments, the taper of the inside surface <NUM> of the wall <NUM> may be in the range from about <NUM>% to about <NUM>% decreasing in a proximal to distal direction. In a specific embodiment, the taper of the inside surface <NUM> of the wall <NUM> is about <NUM>% decreasing in a proximal to distal direction. The lower limit of the taper of the inside surface <NUM> of the wall <NUM> decreasing in a proximal to distal direction may include <NUM>%, <NUM>%, <NUM>%, <NUM>%. The upper limit of the taper of the inside surface <NUM> of the wall <NUM> decreasing in a proximal to distal direction may include <NUM>%, <NUM>%, <NUM>%, <NUM>%. In one or more embodiments, the inside surface <NUM> of the wall <NUM> may have a taper of more than <NUM>% decreasing in a proximal to distal direction or an inner cross-section dimension that decreases from the proximal end <NUM> toward the distal end <NUM> at a rate of more than <NUM>%.

In one or more embodiments, the length of the cavity <NUM> measured from the proximal end <NUM> to the end of the second narrowed wall <NUM>, but not including the second narrowed wall, may be in the range from about <NUM> inches to about <NUM> inches. In a more specific embodiment, the length of the cavity <NUM> from the proximal end <NUM> to the end of the second narrowed wall <NUM>, but not including the second narrowed wall <NUM>, may be in the range from about <NUM> inches to about <NUM> inches. In an even more specific embodiment, the length of the cavity <NUM> may be about <NUM> inches.

The outside surface <NUM> of the female non-luer connector includes at least one arm that extends from the first narrowed wall <NUM> to a location adjacent to the open distal end <NUM> of the hub. In the embodiment shown in <FIG>, the female non-luer connector <NUM> includes two arms <NUM>, <NUM> that are disposed on opposite sides of the female non-luer connector <NUM> and extend from the first narrowed wall <NUM> to a location adjacent to the open distal end <NUM>. The arms <NUM>, <NUM> define spaces <NUM>, <NUM> between the outside surface <NUM> of the female non-luer connector and the arms <NUM>, <NUM>. The arms <NUM>, <NUM> provide a finger grip area or a gripping surface on which to grasp the female non-luer connector <NUM> during use. The arms <NUM>, <NUM> may have any shape known to provide such a finger grip area. In one or more alternative embodiments, the female non-luer connector <NUM> may be free of any structure on its outside surface <NUM>.

Adjacent to the open distal end <NUM>, the female non-luer connector includes an annular disc <NUM> disposed adjacent to the two arms <NUM>, <NUM> that extends radially outwardly from the outside surface <NUM> of the hub. Four discrete protrusions <NUM>, <NUM>, <NUM>, <NUM> extend radially outwardly from the outside surface <NUM> and extend from the annular disc <NUM> to the open distal end <NUM> along the same axis. The four discrete protrusions <NUM>, <NUM>, <NUM>, <NUM> are located along the third narrowed wall <NUM>, as shown in <FIG>.

As shown more clearly in <FIG>, the rim <NUM> may include an indentation for use with a stylet and a spinal needle. In one or more alternative embodiments, the indentation provides a needle bevel orientation indicator in which the indentation is aligned with the bevel of a needle cannula.

One or more embodiments of a non-luer connector for use in a drug delivery device according to the first aspect of the present disclosure are shown in <FIG> illustrate a non-luer connector <NUM> that includes a non-luer portion <NUM> for attachment to another non-luer connector, for example, the female non-luer connector <NUM> described above. The non-luer connector <NUM> of <FIG> is shown integrally formed to a container in the form of a syringe barrel <NUM>. The container may be provided in other forms, for example, a drug bag, an epidural pump and other containers known in the art. The syringe barrel <NUM> shown in <FIG> includes a distal end <NUM>, an open proximal end <NUM> and a sidewall <NUM> extending between the distal end <NUM> to the open proximal end <NUM>. The sidewall <NUM> includes an inside surface <NUM> that defines a chamber <NUM> for retaining fluids, which may include liquid medication and/or other liquids. The open proximal end <NUM> may include an option flange <NUM> and the distal end <NUM> includes a distal wall <NUM>. The non-luer portion <NUM> is integrally formed or provided in the container. Specifically, in the embodiment shown in <FIG>, the non-luer portion <NUM> is provided in the form of a tip <NUM> that extends in the distal direction from the distal wall <NUM> and includes an opening <NUM>. The tip <NUM> extends from the distal wall <NUM> to a distal end <NUM> of the tip. The tip <NUM> includes an outside surface <NUM> and an inside surface <NUM> that defines a passageway <NUM> permitting fluid communication between the chamber <NUM> and the opening <NUM>.

In the embodiment shown, the tip <NUM> has a dimension and/or shape that prevent the connection of a standard female luer connector, for example, the needle hub <NUM> shown in <FIG>, to the syringe barrel <NUM>. Specifically, the non-luer portion <NUM> has a square cross-section and/or an outer cross-sectional dimension that is not compatible with typical luer connectors which have a circular cross-section and/or smaller or larger outer cross-sectional dimension. In the embodiment shown, the tip <NUM> is shown in the form of four discrete walls <NUM>, <NUM>, <NUM>, <NUM> that are connected to form an enclosure around the passageway <NUM> of the tip <NUM> having a square cross-section. In one or more embodiments, the outer cross-sectional dimension of the tip <NUM>, measured from the outside surface <NUM> of the tip <NUM> at the intersection of walls <NUM> and <NUM> and the intersection of walls <NUM> and <NUM> is greater than the inner cross-sectional dimension of the inside surface <NUM> of the hub body <NUM> of luer connector <NUM> of the needle hub <NUM>. Accordingly, the hub body <NUM> cannot fit or slide over the tip <NUM> such that the tip <NUM> is disposed within the cavity <NUM> and the inside surface <NUM> of the hub body <NUM> cannot form an interference fit connection and/or fluid-tight engagement with the outside surface <NUM> of the tip <NUM>. Accordingly, the non-luer portion <NUM> prevents connection of a standard female luer connector, for example, the luer connector <NUM> of needle hub <NUM>. As will be described below, the non-luer portion <NUM> has a dimension and/or shape that permit connection to another corresponding non-luer connector.

In one or more alternative embodiments, the tip <NUM> may have an outer cross-sectional dimension that is smaller than the inner cross-sectional dimension of a standard female luer connector. In such embodiments, the smaller outer cross-sectional dimension of the tip <NUM> prevents sufficient contact between the inside surface <NUM> of the luer connector and the outside surface <NUM> of the tip to form an interference fit connection and/or fluid-tight engagement there between.

In one or more embodiments, even if the inside surface <NUM> of the hub body <NUM> had a inner cross-sectional dimension large enough to permit the hub body <NUM> to slide over the outside surface <NUM> of the tip <NUM> such that the tip <NUM> is disposed within the cavity <NUM>, the square cross-section of the tip <NUM> prevents the inside surface <NUM> of the hub body <NUM> from having sufficient contact with the outside surface <NUM> of the tip <NUM> to form an interference fit connection and/or a fluid-tight seal with the outside surface <NUM> of the tip <NUM>. This is because the inside surface <NUM> is curved and would not contact the outside surface <NUM> of the tip <NUM>. In other words, the corners of the tip <NUM> having a square cross-section would not be in contact with the inside surface of a hub with a circular cross-section, for example needle hub <NUM>. In one or more alternative embodiments, the tip <NUM> may have a triangular cross-section, or other cross-section that prevents sufficient contact with the inside surface of a standard female luer connector, for example the inside surface <NUM> of luer connector <NUM>, thereby preventing the formation of an interference fit connection and/or fluid-tight seal there between.

The tip <NUM> may also have a length that prevents formation of an interference fit connection and/or fluid-tight engagement with a standard female luer connector. Specifically, the length of the tip <NUM> may be too long or too short to permit the respective taper of the tip <NUM> and the inside surface <NUM> of the luer connector to align to form an interference fit connection and/or fluid-tight engagement there between.

In one or more embodiments, the tip <NUM> has an outer cross-sectional dimension of <NUM> inches or less at the distal end <NUM>. In a more specific embodiment, the tip <NUM> has an outer cross-sectional dimension in the range from about <NUM> inches to about <NUM> inches at the distal end <NUM>, or more specifically, in the range from about <NUM> inches to about <NUM> inches. In an even more specific embodiment, the tip <NUM> may have an outer cross-sectional dimension at the distal end <NUM> in the range from about <NUM> inches to about <NUM> inches. In one or more specific embodiments, the outer cross-sectional dimension of the tip <NUM> at the distal end <NUM> is in the range from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, or from about <NUM> inches to about <NUM> inches. The upper limit of the outer cross-sectional dimension of the tip <NUM> at the distal end <NUM> may include <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches. The lower limit of the outer cross-sectional dimension of the tip <NUM> at the distal end <NUM> may include <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches.

In one or more embodiments, the outside surface <NUM> of the tip <NUM> may have a taper of less than <NUM>% decreasing in a proximal to distal direction or an outer cross-sectional dimension that decreases in a proximal to distal direction at a rate of less than <NUM>%. In one or more specific embodiments, the outside surface <NUM> of the tip <NUM> may have a taper decreasing in a proximal to distal direction in the range from about <NUM>% to about <NUM>% or from about <NUM>% to about <NUM>%. In a specific embodiment, the outside surface <NUM> of the tip <NUM> has a <NUM>% taper decreasing in the proximal to distal direction.

In one or more embodiments, the outside surface <NUM> of the tip <NUM> may have a taper of more than <NUM>% decreasing in a proximal to distal direction or an outer cross-sectional dimension that decreases in a proximal to distal direction at a rate of more than <NUM>%.

In one or more embodiments, the length of the tip <NUM> from the distal wall <NUM> to the distal end <NUM> of the tip may be in the range from about <NUM> inches to about <NUM> inches. In one or more specific embodiments, the length of the tip <NUM> may be in the range from about <NUM> inches to about <NUM> inches, or more specifically, in the range from about <NUM> inches to about <NUM> inches. In an even more specific embodiment, the length of the tip <NUM> may be about <NUM> inches.

In use with a corresponding non-luer connector, for example, the female non-luer connector <NUM> of <FIG>, the tip <NUM> is inserted into the cavity <NUM> of the female non-luer connector <NUM>. A force is applied to the syringe barrel <NUM> in the distal direction and/or to the female non-luer connector <NUM> in the proximal direction to cause the inside surface <NUM> of the wall <NUM> of the female non-luer connector to engage the outside surface <NUM> of the tip <NUM> in an interference fit connection and/or fluid-tight engagement. To remove the female non-luer connector <NUM> from the syringe barrel <NUM>, a force is applied to the container in the proximal direction and/or to the female non-luer connector <NUM> in the distal direction to disengage the interference fit connection and/or the fluid-tight engagement of there between.

<FIG> illustrate another embodiment of a non-luer connector <NUM> for use in a drug delivery device according to the first aspect of the present disclosure. Specifically, <FIG> illustrate a non-luer connector <NUM> that includes a non-luer portion <NUM> for attachment to a non-luer connector, for example, the female non-luer connector <NUM> described above. The non-luer connector <NUM> is shown integrally formed to a container in the form of a syringe barrel <NUM>, as described above with reference to <FIG>. As mentioned above with respect to <FIG>, the container may be provided in other forms, for example, a drug bag, an epidural pump and other containers known in the art. The syringe barrel <NUM> shown in <FIG> includes a distal wall <NUM>. The non-luer portion <NUM> is integrally formed or provided in the container. Specifically, in the embodiment shown in <FIG>, the non-luer portion <NUM> is provided in the form of a tip <NUM> that extends in the distal direction from a distal wall <NUM> of the syringe barrel <NUM> and includes an opening <NUM>. The tip <NUM> includes a body wall <NUM> that extends from the distal wall <NUM> to a distal end <NUM> of the tip. The body wall <NUM> that includes an outside surface <NUM> and an inside surface <NUM> that define a passageway <NUM> permitting fluid communication between the chamber of the syringe barrel <NUM> and the opening <NUM>. The distal end <NUM> of the tip <NUM> also includes an end wall <NUM> that extends inwardly from the outside surface <NUM> of the body wall <NUM> to the opening <NUM>.

In the embodiment shown, the body wall <NUM> has a dimension and/or shape that prevent the connection of a standard female luer connector, for example, the needle hub <NUM> shown in <FIG>, to the syringe barrel <NUM>. Specifically, the body wall <NUM> of the non-luer portion <NUM> has an outer cross-sectional dimension and/or a thickness that is not compatible with typical luer connectors, which have smaller or larger inner cross-sectional dimension. In the embodiment shown, the body wall <NUM> is shown in the form of a continuous wall having a circular cross-section that forms an enclosure around the passageway <NUM> of the tip <NUM> having a square cross-section. In one or more embodiments, the outer cross-sectional dimension of the body wall <NUM> at the outside surface <NUM> is greater than the inner cross-sectional dimension of the inside surface <NUM> of the hub body <NUM> of luer connector <NUM> of the needle hub. Accordingly, the hub body <NUM> cannot fit or slide over the body wall <NUM> such that the tip <NUM> is disposed within the cavity <NUM> and the inside surface <NUM> of the hub body <NUM> cannot form an interference fit connection and/or fluid-tight engagement with the outside surface <NUM> of the body wall <NUM>. Accordingly, the non-luer portion <NUM> prevents connection of a standard female luer connector, for example, needle hub <NUM>. As will be described below, the non-luer portion <NUM> has an outer cross-sectional dimension that permits connection to another corresponding non-luer connector.

The thickness of the body wall <NUM> may also have a dimension that prevents connection of a standard female luer connector to the non-luer connector <NUM>. Specifically, the body wall <NUM> may have a thickness that increases the outer cross-sectional dimension of the tip <NUM>, which, as discussed above, prevents formation of an interference fit connection and/or fluid-tight engagement of with a standard female luer connector. The thickness of the body wall <NUM> may also be modified by decreasing the cross-sectional dimension of the passageway <NUM> and maintaining the outer cross-sectional dimension of the tip <NUM>.

In one or more alternative embodiments, the tip <NUM> may have an outer cross-sectional dimension that is smaller than the inner cross-sectional dimension of a standard female luer connector, for example, the luer connector <NUM> of needle hub <NUM>, shown in <FIG>. In such embodiments, the smaller outer cross-sectional dimension of the body wall <NUM> prevents sufficient contact between the inside surface <NUM> of the luer connector and the outside surface <NUM> of the body wall to form a interference fit connection and/or fluid-tight engagement there between. The non-luer portion <NUM> or the tip <NUM> may also have a length that prevents formation of an interference fit connection and/or fluid-tight engagement with a standard female luer connector, for example the luer connector <NUM> of <FIG>. Specifically, the length of the body wall <NUM> may be too long or too short to permit the respective taper of the body wall <NUM> and the inside surface <NUM> of the luer connector to align to form an interference fit connection and/or fluid-tight engagement there between.

In one or more embodiments, the tip <NUM> has an outer cross-sectional dimension of less than <NUM> inches at the distal end 433of the tip or at the end wall <NUM>. It will be understood that the outer cross-sectional dimension of the tip <NUM> includes the longest distance between two points on the outer surface <NUM> of the tip. In a more specific embodiment, the tip <NUM> has an outer cross-sectional dimension in the range from about <NUM> inches to about <NUM> inches, or more specifically, in the range from about <NUM> inches to about <NUM> inches at the distal end <NUM> of the tip or at the end wall <NUM>. In an even more specific embodiment, the tip <NUM> may have an outer cross-sectional dimension in the range from about <NUM> inches to about <NUM> inches at the end wall <NUM> or at the distal end of the tip. In one or more specific embodiments, the outer cross-sectional dimension of the tip <NUM> at the end wall <NUM> or at the distal end <NUM> of the tip is in the range from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, or from about <NUM> inches to about <NUM> inches. The upper limit of the outer cross-sectional dimension of the tip <NUM> at the end wall <NUM> or distal end <NUM> of the tip may include <NUM> inches,. <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches. The lower limit of the outer cross-sectional dimension of the tip <NUM> at the end wall <NUM> or at the distal end <NUM> of the tip may include <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches.

In one or more embodiments, the outside surface <NUM> of the tip <NUM> may have a taper of less than <NUM>% decreasing in a proximal to distal direction or an outer cross-section dimension that decreases in a proximal to distal direction at a rate of less than <NUM>%. In one or more specific embodiments, the outside surface <NUM> of the tip <NUM> may have a taper decreasing in a proximal to distal direction in the range from about <NUM>% to about <NUM>% or from about <NUM>% to about <NUM>%. In a specific embodiment the outside surface <NUM> of the tip <NUM> may have a taper of <NUM>% decreasing in the proximal to distal direction.

In one or more embodiments, the length of the tip <NUM> from the distal wall <NUM> to the distal end <NUM> of the tip or at the end wall <NUM> may be in the range from about <NUM> inches to about <NUM> inches. In one or more specific embodiments, the length of the tip <NUM> from the distal wall <NUM> to the distal end <NUM> of the tip or at the end wall <NUM> may be in the range from about <NUM> inches to about <NUM> inches, or more specifically, in the range from about <NUM> inches to about <NUM> inches. In an even more specific embodiment, the length of the tip <NUM> from the distal wall <NUM> to the distal end <NUM> of the tip or at the end wall <NUM> may be about <NUM> inches.

One or more embodiments of a non-luer connector <NUM> for use in a drug delivery device according to the second aspect of the present disclosure are shown in <FIG> illustrate a non-luer connector <NUM> that includes a non-luer element <NUM> that prevents attachment of a standard female luer connector, for example, needle hub <NUM> described above, thereto. The non-luer connector <NUM> of <FIG> is shown integrally formed to a container in the form of a syringe barrel <NUM>, as described above with reference to <FIG>. The container may be provided in other forms, for example, a drug bag, epidural pump and other containers known in the art. The syringe barrel <NUM> shown in <FIG> includes a distal wall <NUM>. A tip <NUM> extends in the distal direction from a distal wall <NUM> of the syringe barrel <NUM> and includes a passageway <NUM> and an opening <NUM> in fluid communication with the chamber of the syringe barrel.

The outside surface <NUM> of the tip may have a dimension and/or shape that forms an interference fit connection and/or fluid-tight engagement with the inside surface of a corresponding non-luer connector. In one or more embodiments, the outside surface <NUM> of the tip has a dimension and/or shape that may permit a user to force an incorrect interference fit connection and/or an incorrect fluid-tight engagement of the non-luer connector <NUM> with a standard female luer connector. As will be described below, the non-luer element prevents such incorrect connection or engagement. In one or more embodiments, the outside surface <NUM> of the tip has a dimension and/or shape that prevents formation of an interference fit connection and/or fluid-tight engagement with a standard female luer connector and, instead, permits such connection and/or engagement with a corresponding non-luer connector.

In one or more embodiments, the tip <NUM> has an outer cross-sectional dimension of less than <NUM> inches, measured at a distal end <NUM> of the tip. In a more specific embodiment, the tip has an outer cross-sectional dimension measured at the distal end <NUM> in the range from about <NUM> inches to about <NUM> inches, or more specifically, in the range from about <NUM> inches to about <NUM> inches. In an even more specific embodiment, the tip may have an outer cross-sectional dimension measured at the distal end <NUM> in the range from about <NUM> inches to about <NUM> inches. In one or more specific embodiments, the outer cross-sectional dimension of the tip <NUM> measured at the distal end <NUM> is in the range from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, or from about <NUM> inches to about <NUM> inches. The upper limit of the outer cross-sectional dimension of the tip <NUM> measured at the distal end <NUM> may include <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches. The lower limit of the outer cross-sectional dimension of the tip <NUM> measured at the distal end <NUM> may include <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches.

In one or more embodiments, the outside surface <NUM> of the tip <NUM> may have a taper of less than <NUM>% decreasing in a proximal to distal direction or an outer cross-section dimension that decreases in a proximal to distal direction at a rate of less than <NUM>%. In one or more specific embodiments, the outside surface <NUM> of the tip <NUM> may have a taper decreasing in a proximal to distal direction in the range from about <NUM>% to about <NUM>% or from about <NUM>% to about <NUM>%. In a specific embodiment, the outside surface <NUM> of the tip <NUM> has a <NUM>% taper decreasing in a proximal to distal direction.

In one or more embodiments, the length of the tip <NUM> from the distal wall <NUM> to the distal end <NUM> of the tip may be in the range from about <NUM> inches to about <NUM> inches. In one or more specific embodiments, the length of the tip <NUM> from the distal wall <NUM> to the distal end <NUM> of the tip may be in the range from about <NUM> inches to about <NUM> inches, or more specifically, in the range from about <NUM> inches to about <NUM> inches. In an even more specific embodiment, the length of the tip <NUM> from the distal wall <NUM> to the distal end <NUM> of the tip may be about <NUM> inches.

The non-luer element <NUM> is integrally formed or provided in the container. Specifically, in the embodiment shown in <FIG>, the non-luer element <NUM> is integrally formed and disposed on the distal wall <NUM> of the syringe barrel and extends in the distal direction in a coaxial relationship with the tip <NUM>. The non-luer element <NUM> forms a channel <NUM> between the tip <NUM> and the non-luer element <NUM>. In the embodiment shown, the non-luer element <NUM> is shown as a plurality of barrier walls <NUM> that extend from the distal wall <NUM> in the distal direction. The barrier wall <NUM> includes a free or unattached distal end <NUM> and a proximal end <NUM>. The barrier wall <NUM> may be described as cantilevered with respect to the distal wall <NUM>.

The barrier wall <NUM> includes an inside surface <NUM> that faces the channel <NUM> and an outside surface <NUM>. In the embodiment shown, the barrier wall <NUM> has a length that is equal to the length of the tip <NUM>. In one or more alternative embodiments, the length of the barrier wall <NUM> may be less than or greater than the length of the tip <NUM>. When the length of the barrier wall <NUM> is less than the length of the tip <NUM>, it should not be so short that it fails to prevent the user from forcing an incorrect connection with a standard female luer connector. That is, the length of the barrier wall <NUM> is still sufficient to prevent such an incorrect connection. The length of the barrier wall <NUM> when it is longer than the tip <NUM> is not particularly limited except by practical considerations related to ease of manufacturing and ease of use. In one or more embodiments, the difference between the length of the barrier wall <NUM> and the length of the tip <NUM> is less than about <NUM> inches. In one or more specific embodiments, the difference between the length of the barrier wall <NUM> and the length of the tip <NUM> is in the range from about <NUM> inches to about <NUM> inches or from about <NUM> inches to about <NUM> inches.

The inside surface <NUM> of the barrier wall <NUM> may have a plurality of threads disposed thereon for engaging a corresponding structure of a non-luer connector. For example, when female non-luer connector <NUM> is attached to the non-luer connector <NUM>, the tab <NUM> disposed on the outside surface <NUM> of the female non-luer connector engages the plurality of threads disposed on the inside surface <NUM> of the barrier wall <NUM>. Engagement between the plurality of threads and the tab <NUM> is achieved by rotating the syringe barrel <NUM> and/or the non-luer connector <NUM> with respect to the female non-luer connector <NUM>.

The barrier wall <NUM> of the embodiment shown in <FIG> has a cross-section that has an outer cross-sectional dimension that is less than or equal to the inner cross-sectional dimension of a standard female luer connector, for example, the inner cross-sectional dimension of the hub body <NUM>, of <FIG>. The outer cross-sectional dimension of the barrier wall <NUM> may be sized to prevent the open proximal end of the luer connector, for example, the hub body <NUM> from entering the channel <NUM> and engaging the outside surface <NUM> of the tip <NUM>. In one or more embodiments, the outer cross-sectional dimension of the barrier wall <NUM> may be less than the inner cross-sectional dimension of a standard luer connector and includes a feature that causes leakage between the standard luer connector and the barrier wall <NUM> when the standard luer connector is attached to the barrier wall <NUM>. In one or more specific embodiments, the outer cross-sectional dimension of the barrier wall <NUM> may have a shape to prevent a standard female luer connector from entering the channel <NUM>.

In one or more specific embodiments, the outer cross-sectional dimension of the barrier wall may larger than <NUM> inches. In one or more alternative embodiments, the thickness of the barrier wall <NUM> may be adjusted such that the inner cross-sectional dimension of the barrier wall <NUM> is less than <NUM> inches or is otherwise sized to prevent the standard female luer connector from entering the channel <NUM>.

In embodiments in which the standard female luer connector incorporates lugs to engage a corresponding male luer lock connector, the outer cross-sectional dimension of the barrier wall <NUM> may be greater than about <NUM> inches. In embodiments, in which the female luer connector does not incorporate lugs, the outer cross-sectional dimension of the barrier wall <NUM> may be greater than about <NUM> inches.

In one or more embodiments, the outer cross-sectional dimension of the barrier wall <NUM> is in the range from about <NUM> inches to about <NUM> inches. In one or more specific embodiments, the outer cross-sectional dimension of the barrier wall <NUM> may be in the range from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches, from about <NUM> inches to about <NUM> inches. The upper limit of the outer cross-sectional dimension of the barrier wall <NUM> may include <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches. The lower limit of the outer cross-sectional dimension of the barrier wall may include <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches.

In one or more embodiments, the barrier wall <NUM> has an inner cross-sectional dimension in the range from about <NUM> inches to about <NUM> inches. In one or more specific embodiments, the inner cross-sectional dimension of the barrier wall <NUM> is in the range from about <NUM> inches to about <NUM> inches or from about <NUM> inches to about <NUM> inches. The lower limit of the inner cross-sectional dimension of the barrier wall <NUM> includes <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches. The upper limit of the outer cross-sectional dimension of the barrier wall <NUM> includes <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, and <NUM> inches.

In one or more embodiments, as shown in <FIG> and <FIG>, the non-luer element <NUM> may be provided as a continuous and singular barrier wall that extends continuously around the tip <NUM>. In one or more embodiments, as shown in <FIG>, the non-luer element <NUM> may be provided as a uniform, continuous and singular barrier wall that extends continuously around the tip <NUM>. In one or more embodiments, as shown in <FIG>, the non-luer element <NUM> may be provided as a continuous and singular barrier wall being flush with tip <NUM> having one or more curves or indentations that extends around the tip <NUM>, where the tip <NUM> is visible through the curve or indentation of the collar. In the embodiment shown in <FIG>, <FIG>, <FIG> and <FIG>, the non-luer element <NUM> is shown as a plurality of barrier walls <NUM> that form at least one aperture <NUM> or a plurality of apertures spaced between the barrier walls <NUM>. In one or more embodiments, as shown in <FIG>, the apertures <NUM> of the embodiment shown extend from the distal end <NUM> to the proximal end <NUM> of the barrier wall. In one or more alternative embodiments, as shown in <FIG> and <FIG>, the apertures <NUM> may extend from the distal end <NUM> to a distance between the distal end <NUM> and the proximal end <NUM>. In embodiments that incorporate apertures <NUM> in the barrier wall, in the event a standard female luer connector is able to fit over the barrier wall <NUM> such that the inside surface of the luer connector is in contact with the outside surface <NUM> of the barrier wall, the apertures <NUM> prevent or inhibit the formation of a fluid-tight seal by providing openings to the exterior of the connector that will result in leakage of fluid delivered through the tip. In one or more alternative embodiments, the aperture <NUM> provides visual indication of whether the non-luer element <NUM> functions similarly to a slip connector or a locking connector. In other words, the aperture <NUM> provides visual indication of whether the non-luer element <NUM> includes a luer slip fitting or a luer lock fitting. Specifically, the presence of the aperture <NUM> provides visual indication that the inside surface <NUM> of the barrier wall <NUM> is free of a plurality of threads or other locking feature that cooperates to lock a corresponding non-luer connector to the barrier wall <NUM>. In one or more embodiments, the absence of the aperture <NUM> provides visual indication that the inside surface <NUM> of the barrier wall <NUM> includes a plurality of threads or other locking feature to lock a corresponding non-luer connector to the barrier wall <NUM>.

In the embodiment shown, the barrier wall <NUM> is shown in the form of discrete walls that, when taken together, have a circular cross-section that forms a partial enclosure around the tip <NUM> that also has a circular cross-section. In one or more embodiments, the barrier wall <NUM> may have a triangular cross-section or other non-circular cross-section, which would prevent a standard female luer connector having a circular cross-section, for example the hub body <NUM> of <FIG>, from fitting or sliding within the channel <NUM> preventing the tip <NUM> and the inside surface <NUM> of the hub body <NUM> from forming an interference fit connection and/or fluid-tight engagement with the outside surface <NUM> of the tip <NUM>. Accordingly, the non-luer element <NUM> prevents connection of a standard female luer connector, for example, the luer connector <NUM> of needle hub <NUM>, to the syringe barrel <NUM>.

In one or more alternative embodiments, the barrier wall <NUM> may have an outer cross-sectional dimension that is smaller than the inner cross-sectional dimension of a standard female luer connector. In such embodiments, the smaller outer cross-sectional dimension of the barrier wall <NUM> prevents sufficient contact between the inside surface <NUM> of the standard female luer connector and the outside surface <NUM> of the barrier wall <NUM> to form a interference fit connection and/or fluid-tight engagement there between. The barrier wall <NUM> may also have a length that prevents formation of an interference fit connection and/or fluid-tight engagement with a standard female luer connector, for example the luer connector <NUM> shown in <FIG>. Specifically, the length of the barrier wall <NUM> may be too long or too short to permit fluid-tight engagement with the inside surface <NUM> of the luer connector <NUM>.

As will be described below, the non-luer element <NUM> may have an outer cross-sectional dimension that permits connection to another corresponding non-luer connector. For example, the female non-luer connector <NUM> may have an exterior surface with an exterior cross-sectional dimension sized to fit within the channel <NUM> such that the inside surface <NUM> forms an interference fit connection and/or fluid-tight engagement with the outside surface <NUM> of the tip.

As described above with reference to <FIG>, the non-luer element <NUM> may also be utilized to prevent the user from forcing an incorrect interference fit connection and/or fluid-tight engagement between the tip <NUM> and a standard female luer connector when the female luer connector incorporates a soft or semi-rigid material, typically a rubber or elastomeric valve or seal. In such devices the rubber or elastomeric valve or seal may prevent the user from seeing leakage of the incorrect connection between the male and female connectors because the valve or seal conforms to the size and shape of the non-luer connector, sealing leaking fluid within the female luer connector. Such valves or seals are typically disposed within the hub cavity or on the inside surface of the hub cavity of standard female luer connectors. Standard female luer connectors with such valves or seals may be referred to as soft luer connectors or semi-rigid luer connectors. The valves or seals are typically utilized to allow the inside surface or the cavity of the standard female luer connector to conform to a variety of shapes. This prevents leakage between the male connector and the standard female connector due to insufficient formation of a fluid-tight seal between the standard female luer connector and a male connector. In such embodiments, the outer surface <NUM> of the tip <NUM> could potentially be connected to the standard female luer connector, with the valve or seal providing a seal between the tip <NUM> and the standard female luer connector. In one or more embodiments, the barrier wall <NUM> is shaped and/or sized to have inner cross-sectional dimension that prevents connection of a standard female luer connector that includes a valve or seal, as described above, to the tip <NUM>. Specifically, the inner cross-sectional dimension of the barrier wall <NUM> is greater than the inner cross-sectional dimension of a standard female luer connector and less than the outer cross-sectional dimension of a standard female luer connector. Accordingly, an attempt to connect the standard female luer connector to the non-luer connector <NUM> will result in alignment of the hub body of the standard female luer connector with the barrier wall <NUM> such that the barrier wall <NUM> will physically block the tip <NUM> from penetrating the rubber or elastomeric valve or seal and therefore prevent the hub body of the standard female luer connector from attaching to the tip <NUM>. Accordingly, the non-luer connector <NUM> minimizes the risk that a user can utilize the non-luer connector <NUM> described herein with an unintended standard female soft luer connector.

In use, to assemble the non-luer connector <NUM> to a correct, corresponding non-luer connector, for example, the female non-luer connector <NUM> shown in <FIG>, the wall <NUM> is inserted into the channel <NUM> between the barrier wall <NUM> and the tip <NUM> such that the tip <NUM> is disposed within the cavity <NUM>. A force is applied in the distal direction on the syringe barrel <NUM> until the outside surface <NUM> of the tip engages the inside surface <NUM> of the wall of the female non-luer connector <NUM>. In embodiments which utilize a threaded portion on the inside surface <NUM> of the barrier wall <NUM>, the wall <NUM> of the female non-luer connector <NUM> is inserted into the channel <NUM> and rotated with respect to the syringe barrel <NUM> such that the tab <NUM> engages the threaded portion.

One or more embodiments of a non-luer connector <NUM> for use in a drug delivery device according to the second aspect of the present disclosure are shown in <FIG> illustrate a non-luer connector <NUM> that includes a non-luer element <NUM> that prevents attachment of a standard female luer connector, for example needle hub <NUM> described above. The non-luer connector <NUM> of <FIG> is shown integrally formed with a container in the form of a syringe barrel <NUM>, as described above with reference to <FIG>. The container may be provided in other forms, for example, a drug bag, epidural pump or other containers known in the art. The syringe barrel <NUM> shown in <FIG> includes a distal wall <NUM> and a tip <NUM> that extends in the distal direction from the distal wall <NUM>. The tip <NUM> includes a passageway <NUM> and an opening <NUM> in fluid communication with the chamber of the syringe barrel <NUM>. The tip <NUM> has a distal end <NUM> and a proximal end <NUM>.

The outside surface <NUM> of the tip may have a dimension and/or shape that forms an interference fit connection and/or fluid-tight engagement with the outside surface of a corresponding non-luer connector, for example, the female non-luer connector <NUM>. It will be appreciated, however, that the dimension and/or shape of the outside surface <NUM> of the tip according to the disclosure may permit the user to force an incorrect interference fit connection and/or fluid-tight engagement of the non-luer connector <NUM> with a standard female luer connector. As will be described below, the non-luer element <NUM> prevents such incorrect connection or engagement thereof. In one or more embodiments, the outside surface <NUM> of the tip has a dimension and/or shape that prevents forcing of an interference fit connection and/or fluid-tight engagement with a standard female luer connector but permits such connection and/or engagement with a corresponding non-luer connector. In one or more embodiments, the outside surface <NUM> of the tip has an outer cross-sectional dimension as described with reference to <FIG>. In one or more embodiments, the outside surface <NUM> of the tip <NUM> may have a taper as also described with reference to <FIG>. The outside surface <NUM> of the tip <NUM> of one or more embodiments may have a length as described with reference to <FIG>.

The non-luer element <NUM> is integrally formed or provided in the container. Specifically, in the embodiment shown in <FIG>, the non-luer element <NUM> is integrally formed and disposed on outside surface <NUM> of the tip <NUM>. The non-luer element <NUM> extends radially outwardly from the outside surface <NUM> of the tip. The non-luer element <NUM> includes an exterior surface <NUM> that defines an outer cross-sectional dimension that is greater than the outer cross-sectional dimension of the tip <NUM>, when measured from the outside surface <NUM> of the tip. In the embodiment shown, the non-luer element <NUM> is shown as a circular disc having at least one narrowing edge <NUM>.

The non-luer element <NUM> is disposed between the distal end <NUM> and a proximal end <NUM> of the tip <NUM>. In the embodiment shown, the non-luer element <NUM> is disposed approximately at a mid-point between the distal end <NUM> and a proximal end <NUM>. In one or more alternative embodiments, the non-luer element <NUM> may be disposed adjacent to or at the distal end <NUM> of the tip <NUM>. Optionally, the non-luer element <NUM> may be disposed adjacent to or at the proximal end <NUM> of the tip <NUM>.

The position of the non-luer element <NUM> in one or more embodiments may be modified to prevent connection of a standard female luer connector to the tip <NUM>. Specifically, in one or more embodiments, the non-luer element <NUM> may be disposed closer to the distal end <NUM> of the tip <NUM> to allow fluid-tight engagement only of corresponding female non-luer connectors having an inside cavity of shorter length than the cavity of standard female luer connectors. Accordingly, the non-luer element <NUM> prevents the standard female luer connector from fully sliding in the proximal direction over the tip <NUM> and prevents formation of an interference fit connection and/or fluid-tight engagement between the standard female luer connector and the tip <NUM>. That is, the standard female luer connector will contact the non-luer element <NUM> before it has been moved sufficiently proximally on the tip <NUM> to form a fluid-tight connection by contact of the outside surface <NUM> of the tip with the inner surface of the standard female luer connector.

The non-luer element <NUM> of the embodiment shown in <FIG> has a cross-section that has an outer cross-sectional dimension that is greater than the inner cross-sectional dimension of a standard female luer connector, for example, the luer connector <NUM> of needle hub <NUM> shown in <FIG>. Specifically, the outer cross-sectional dimension of the non-luer element <NUM> prevents the open proximal end of the standard female luer connector, for example, the hub body <NUM>, from sliding over or fitting over the outside surface <NUM> of the tip and fully engaging the outside surface <NUM> of the tip <NUM>. In other words, the non-luer element <NUM> functions as a barrier to movement of the luer connector over the tip <NUM> in the proximal direction.

In one or more embodiments, the outer cross-sectional dimension of the non-luer element <NUM> is in the range from about <NUM> inches to about <NUM> inches. In one or more specific embodiments, the outer cross-sectional dimension of the non-luer element <NUM> is in the range from about <NUM> inches to about <NUM> inches or from about <NUM> inches to about <NUM> inches. The upper limit of the outer cross-sectional dimension of the non-luer element <NUM> includes <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches. The lower limit of the cross-sectional dimension of the non-luer element <NUM> includes <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches.

In the embodiment shown in <FIG>, the non-luer element <NUM> may be provided as a continuous and singular disc-like structure that extends continuously circumferentially around the tip <NUM>. In one or more embodiments, the non-luer element <NUM> may be provided in the form of discrete projections disposed around a portion of the circumference of the outside surface <NUM> of the tip <NUM>. Spaces may be provided between the projections. In embodiments that incorporate discrete projections and/or spaces there between, in the event a standard female luer connector is able to fit over the non-luer element <NUM> such that the inside surface of the luer connector is in contact with the exterior surface <NUM> of the non-luer element <NUM>, the spaces would prevent or inhibit the formation of a fluid-tight seal by providing areas of the non-luer element <NUM> and/or outside surface <NUM> of the tip that are not in contact with the inside surface of the luer connector. In one or more specific embodiments, the spaces would result in openings from the interior of the standard female luer connector to the outside surface <NUM> of the of the non-luer connector that would cause the fluid to leak.

In the embodiment shown, the non-luer element <NUM> has a circular cross-section. In one or more embodiments, the non-luer element <NUM> may have a square, triangular cross-section or other non-circular cross-section, which would prevent a standard female luer connector having a circular cross-section, for example the luer connector <NUM> of needle hub <NUM> of <FIG>. Specifically, the hub body <NUM> of needle hub <NUM> would be prevented from fitting or sliding over the non-luer element <NUM> such that the tip <NUM> and the inside surface <NUM> of the hub body <NUM> would not be able to form an interference fit connection and/or fluid-tight engagement with the outside surface <NUM> of the tip <NUM>. Accordingly, the non-luer element <NUM> prevents connection of a standard female luer connector to the syringe barrel <NUM> of the non-luer connector <NUM>. Specifically, if the non-luer element <NUM> has a non-circular outer cross-sectional dimension that is smaller than the inner cross-sectional dimension of the standard circular female luer, there will be gaps in the contact points between the non-luer element <NUM> and/or tip <NUM> that would cause the fluid to leak.

As will be described below, the non-luer element <NUM> is positioned on the tip <NUM> to permit connection of the tip <NUM> to another corresponding non-luer connector. For example, the cavity <NUM> of a female non-luer connector <NUM> may have length that is equal to the length of the tip <NUM> from its distal end <NUM> to the non-luer element <NUM> such that the inside surface <NUM> forms an interference fit connection and/or fluid-tight engagement with the exterior surface <NUM> of tip <NUM>. Accordingly, in one or more embodiments, the non-luer element <NUM> is positioned such that the length of the tip <NUM> between a point distally adjacent to the non-luer element <NUM> and the distal end <NUM> of the tip is less than or equal to the length of the cavity <NUM> of the female non-luer connector <NUM> to permit formation of an interference fit connection and/or fluid-tight engagement between the tip <NUM> and the female non-luer connector <NUM>.

In one or more embodiments, the non-luer element <NUM> is positioned, shaped and/or sized to have an outer cross-sectional dimension that prevents connection of the tip <NUM> to a standard female luer connector that includes a valve or seal, as described above with reference to <FIG>. In one or more embodiments, the non-luer element <NUM> is positioned such that the standard female luer connector is prevented from sliding over the length of the tip <NUM> such that, upon penetration of the valve or seal by the tip <NUM>, the opening <NUM> of the tip <NUM> remains adjacent or near the open proximal end of the standard female luer connector but does not enter the cavity sufficiently to cause any substantial contact between the outside surface of the tip <NUM> and the inside surface of the standard female luer connector. That is, the valve or seal of the standard female luer connector contacts the non-luer element <NUM> and prevents further proximal movement of the standard female luer connector before substantial contact between the tip <NUM> and the standard female luer connector is achieved. The position of the opening <NUM> compromises the sealing ability of the valve or seal disposed within the cavity of the standard female luer connector and visible leakage occurs despite the presence of the valve or seal. Accordingly, the non-luer connector <NUM> minimizes the risk that a user can inadvertently utilize the non-luer connector <NUM> described herein with an unintended standard female luer connector.

In use, to assemble the non-luer connector <NUM> to a corresponding non-luer connector, for example, the female non-luer connector <NUM> shown in <FIG>, the tip <NUM> of the non-luer connector <NUM> is disposed within the cavity <NUM> of the hub. A force is applied in the distal direction on the non-luer connector <NUM> until the outside surface <NUM> of the tip <NUM> engages the inside surface <NUM> of the wall of the female non-luer connector <NUM> in an interference fit connection and/or fluid-tight engagement.

One or more embodiments of a non-luer connector <NUM> for use in a drug delivery device according to the third aspect of the present disclosure are shown in <FIG> illustrate a non-luer connector <NUM> that includes structure to prevent the formation of a fluid-tight connection between the non-luer connector <NUM> and a standard female luer connector by increasing the leakage or possibility of leakage of liquid in a misconnection. The non-luer connector <NUM> also has structure that enables attachment of the non-luer connector <NUM> to another corresponding non-luer connector, for example, the female non-luer connector <NUM>. The non-luer connector <NUM> of <FIG> is shown integrally formed to a container, provided in the form of a syringe barrel <NUM>, as described above with reference to <FIG>. The container may be provided in other forms, for example, a drug bag, epidural pump and other containers known in the art. The syringe barrel <NUM> shown in <FIG> includes a distal wall <NUM>. A tip <NUM> extends in the distal direction from the distal wall <NUM> and includes a passageway <NUM> and an opening <NUM> in fluid communication with the chamber of the syringe barrel <NUM>. The tip <NUM> has a distal end <NUM> and a proximal end <NUM>. The tip includes an end wall <NUM> disposed at the distal end <NUM> that extends from the opening <NUM> to the outside surface <NUM> of the tip.

The outside surface <NUM> of the tip may have a dimension and/or shape that prevent the formation of a fluid-tight engagement with the inside surface of a standard female luer connector. In the embodiment shown, the tip <NUM> includes a non-luer element that is integrally formed thereon. Specifically, the end wall <NUM> includes a notch <NUM> or other structure for enlarging the opening <NUM> of the tip such that it extends to the outside surface <NUM> of the tip. In other words, the notch <NUM> provides a path for fluid to escape from the opening <NUM> to the outside surface <NUM> of the tip even when the end wall <NUM> is pressed against a flat surface, such as the end wall of the cavity of a standard female luer, provided that the inside surface <NUM> of the cavity <NUM> does not form a tight interference fit with the outside surface <NUM> of the non-luer tip <NUM>. To accomplish this, the notch <NUM> extends from the passageway through the sidewall to form an aperture in the side wall at the distal end of the tip. The notch <NUM> may provide a beveled or curved edge to the distal end <NUM> of the tip <NUM> adjacent to the outside surface <NUM> of the tip that forms an aperture in the side wall at the distal end of the tip.

To establish fluid-tight engagement between the tip <NUM> and a hub or connector, regardless of whether the hub or connector has a standard female luer connector or female non-luer connector, a fluid-tight seal is typically formed between the outside surface <NUM> of the tip and inside surface of the female connector. If a fluid-tight seal is not formed between the inside surface of the female connector (i.e., the cavity) and the tip <NUM>, a fluid-tight engagement will not be formed between the female connector and the tip <NUM>. If fluid-tight engagement is not formed, leakage may or may not occur for the following reason.

In embodiments in which the outside surface <NUM> of a tip <NUM> has an outer cross-sectional dimension that prevents formation of a fluid-tight seal with the inside surface of a female connector cavity, the distal end <NUM> of the tip <NUM> may have a dimension that allows the end wall <NUM> of the tip <NUM> to contact the distal end of the inside surface of the cavity and potentially form at least a partially fluid-tight seal. That could allow a user to utilize the tip <NUM> with a standard female luer connector. In such situations, the leakage that may occur from the seal between the end wall <NUM> of the tip <NUM> and the distal end of the female connector cavity, even if only partial, may be too minimal to be noticed by the practitioner.

In the embodiment shown in <FIG>, the notch <NUM> disposed on the end wall <NUM> prevents the formation of a fluid-tight seal between the end wall <NUM> and the distal inside surface of a standard female luer hub, for example, the inside surface <NUM> of the needle hub <NUM>, because it provides a larger outlet or avenue for leakage of the fluid within the container. The notch <NUM> thus prevents the formation of a fluid-tight seal at the end wall <NUM> of the tip <NUM> by providing an outlet into the side space between tip <NUM> and the hub even if end wall <NUM> of tip is in fluid-tight contact with the distal inside surface of the hub cavity. Accordingly, the notch <NUM> maximizes leakage between the tip <NUM> and the standard female luer connector if the connection there between is improper because a fluid-tight seal is not formed at the end wall <NUM> and the fluid is permitted to leak between the inside surface <NUM> of the hub and the outside surface <NUM> of the tip.

For a hub or connector to properly establish a fluid-tight engagement at the end wall <NUM>, the female non-luer connector must have a dimension and/or shape to accommodate and enclose the notch <NUM>. The inside surface <NUM> of female non-luer connector <NUM> may be shaped to have a taper which corresponds to the taper of the non-luer male tip, thus providing close contact between the outside surface of the tip and the inside surface of the female connector and substantially eliminating any space between them that could channel leaking fluid out of the female connector. This fully encloses or seals the notch <NUM> and prevents leakage of the fluid from the correct non-luer male-female connection.

The notch <NUM> has a dimension and/or shape that prevents the inside surface of a standard female luer connector from enclosing or sealing the notch <NUM>. In one or more embodiments, the tip <NUM> may have a dimension, taper or shape that allows the notch <NUM> to be positioned or disposed in a manner in which the inside surface of a standard female luer connector cannot enclose or seal the notch <NUM>. Specifically, in embodiments in which the outside surface <NUM> of the tip has a taper, length and/or outer cross-sectional dimension that prevents formation of a fluid-tight with a standard female luer connector, the notch <NUM> may be positioned, have a dimension or shape that prevents the inside surface of the standard female luer connector from contacting or sufficiently enclosing or sealing the notch <NUM>. In one or more embodiments, the length of the tip <NUM> may be modified such that attachment of a standard female luer connector to the tip <NUM> creates dead space within the standard female luer connector and the tip <NUM> that prevents the formation of a seal between the standard female luer connector and the notch <NUM>. In general, the notch will have a depth measured from the end wall <NUM> toward the proximal end <NUM> of the tip <NUM> that is sufficient to result in visible leakage into the dead space of an incorrect male-female connection but not large enough to cause a correct connection to leak in spite of adequate contact between the outside surface of the tip and the inside surface of the female cavity.

In one or more embodiments, the notch <NUM> has a depth measured from the end wall <NUM> toward the proximal end <NUM> of the tip <NUM> in the range from about <NUM> inches to about <NUM> inches. In one or more specific embodiments, the depth of the notch <NUM> may be in the range from about <NUM> inches to about <NUM> inches or from about <NUM> inches to about <NUM> inches. The upper limit of the depth of the notch <NUM> includes <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches. The lower limit of the depth of the notch <NUM> includes <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches. The notch <NUM> of one or more embodiments may have a width or cross-sectional dimension in the range from about <NUM> inches to about <NUM> inches. In one or more specific embodiments, the notch <NUM> has a width in the range from about <NUM> inches to about <NUM> inches or from about <NUM> inches to about <NUM> inches. The upper limit of the width of the notch <NUM> includes <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches. The lower limit of the width of the notch <NUM> may include, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches and <NUM> inches.

The notch <NUM> of <FIG> is shown as an indentation in the wall that extends through the width of the end wall <NUM>. The notch <NUM> may be characterized as two notches that are disposed on opposite sides of the opening <NUM>.

In the embodiment shown in <FIG>, the end wall <NUM> may include two notches <NUM>,<NUM>. In the embodiment shown, the two notches <NUM>, <NUM> are disposed at a right angle with respect to each other, when measured from the opening <NUM>. In one or more alternative embodiments, additional notches may be added. The notches may be spaced at regular or irregular intervals from each other. The notch of <FIG> may also be described as four separate notches that are disposed across the end wall <NUM> and which radiate outwardly from the opening <NUM>. The four notches are shown as disposed at <NUM> degree intervals, when measured from the opening <NUM>.

In the embodiment shown in <FIG>, the end wall <NUM> may include a plurality of notches <NUM> that are disposed adjacent to one another along the circumference of the distal end. The plurality of notches <NUM> surrounds the opening of the tip <NUM>. The plurality of notches <NUM> have a wedge shape, wherein each of the plurality of notches <NUM> extends into the end wall <NUM> and forms a point. In other words, the plurality of notches has a zigzag profile. In one or more embodiments, each of the plurality of notches <NUM> have a first side <NUM> that has a decreasing slope that extends in the proximal direction into the end wall and a second side <NUM> that has an increasing slope that extends from the first side in the distal direction to the first side of an adjacent notch. An edge <NUM> connects the first side and the second side. The edge <NUM> is shown as being angled and/or having a slope that decreases from the outside surface <NUM> to the opening <NUM>. The plurality of notches <NUM> may have a height that, when measured from the end wall <NUM> increases from the opening <NUM> to the outside surface <NUM> of the tip. In other words, the plurality of notches <NUM> may be angled toward the opening <NUM> of the tip.

In one or more embodiments, the angled plurality of notches <NUM> include a cutting edge <NUM> that is adapted to pierce or cut a valve or seal that may be utilized with a standard female luer connector, as described above with reference to <FIG> and <FIG>. Specifically, when a user attempts to assemble a standard female luer connector with a valve or seal to a non-luer connector <NUM>, the cutting edge <NUM> of the plurality of notches cuts and/or pierces the valve or seal thereby preventing the valve or seal from minimizing the leakage between the improperly connected non-luer connector <NUM> and the standard female luer connector. In addition, the cutting edge <NUM> of one or more embodiments may also damage the standard female luer connector, further discouraging or preventing connection of a standard female luer connector to the non-luer connector <NUM>. Accordingly, the cutting edge <NUM> minimizes the risk that a user can utilize the non-luer connector <NUM> described herein with an unintended standard female luer connector.

In one or more embodiments, the notch <NUM> disposed on the end wall <NUM> may be used in conjunction with a plurality of barrier walls <NUM> that form at least one aperture <NUM> or a plurality of apertures spaced between the barrier walls <NUM> to prevent the formation of a fluid-tight seal between the end wall <NUM> and the distal inside surface of a standard female luer hub by providing openings to the exterior of the connector that will result in leakage of fluid delivered through the tip. The apertures <NUM> of the embodiment extend from the distal end <NUM> to the proximal end <NUM> of the barrier wall. In one or more alternative embodiments, the apertures <NUM> may extend from the distal end <NUM> to a distance between the distal end <NUM> and the proximal end <NUM>.

In one or more embodiments, the outside surface <NUM> of the tip may have an outer cross-sectional dimension and/or taper as described above with reference to <FIG>. The tip <NUM> of one or more embodiments may also have a length as described above with reference to <FIG>.

In one or more embodiments, the notch <NUM>, notches <NUM>, <NUM> and plurality of notches <NUM> may be utilized with male connectors that will adopt proposed new standards for neuraxial applications. Specifically, under ISO <NUM>-<NUM>, for small bore connectors for liquids and gases in healthcare applications, the taper of the male connector and female connector will be modified from the existing ISO luer standard of <NUM>% to <NUM>% from their proximal ends to the distal ends. For male connectors, the new <NUM>% taper provides a more gradual decrease in the outer cross-sectional dimension of the connector from the proximal end to the open distal end. For female connectors, the new <NUM>% taper provides a more gradual decrease in the inner cross-sectional dimension of the connector from the open proximal end to the distal end, as shown in <FIG>. In addition, the outer cross-sectional dimension at the open distal end of the male connector will be less than the range of the current ISO luer standard of <NUM> inches to <NUM> inches. Specifically, the current proposed ISO standards provide for the outer cross-sectional dimension for the male connector at the open distal end to measure in the range from about. <NUM> inches to about. <NUM> inches. The inner cross-sectional dimension of the female connector at the open proximal end will be less than the range of the current ISO luer standard of <NUM> inches to <NUM> inches. Specifically, the current proposed ISO standards provide for the inner cross-sectional dimension for the female connector at the open proximal end to measure in the range from about <NUM> inches to about <NUM> inches. The length of the male connector for neuraxial applications will also be increased from <NUM> inches to about <NUM> inches. The length of female connectors for neuraxial applications will also be increased from <NUM> inches to about <NUM> inches.

The more gradual taper in the new ISO standards for neuraxial applications for both male and female connectors and the smaller outer cross-sectional dimension and inner cross-sectional dimensions of the male and female connectors, respectively, are intended to prevent fluid tight connection of a male connector for a neuraxial application with a female standard luer connector and a female connector for a neuraxial application with a male standard luer connector. However, the smaller outer cross-sectional dimension of the male connector for neuraxial applications at the distal end thereof may make it possible for a user to inadvertently or purposely attach the male connector for neuraxial applications to a female standard luer connector, which may have an inner cross-sectional dimension at its distal end that could accommodate the smaller outer cross-sectional dimension of the male connector for neuraxial applications. The ability to attach the male connector for neuraxial applications to a female standard luer connector, even if not ideal, could allow the formation of at least a partial fluid-tight engagement sufficient to deliver unintended fluids or liquids to a patient at an incorrect delivery site.

The notch <NUM>, notches <NUM>, <NUM> and plurality of notches <NUM> described herein connect the opening <NUM> to the outside surface <NUM> of the tip, preventing partial fluid-tight connection between the distal end of the tip and the distal wall of a larger standard female connector, such that a user would not be able establish sufficient fluid-tight engagement to utilize a male connector for neuraxial applications that is incorrectly attached to a female standard luer connector. Specifically, the notches <NUM>, notches <NUM>, <NUM> and plurality of notches <NUM> increase leakage from such an incorrect connection and prevent circumvention of the new ISO proposals for neuraxial applications.

One or more embodiments of the present invention may incorporate a visual indicator to provide visual indication of the compatibility of the components of the drug delivery devices described herein. Specifically, a container having a non-luer connector may have a color or be made from a colored polymeric material that corresponds to the color of a correct corresponding female non-luer connector. In one or more embodiments, the plunger rod of a syringe may also have a color that corresponds to a correct corresponding female non-luer connector. The visual indicators may be placed on the hub body and/or the needle shield of the female non-luer connector. Other visual indicators may include labeling that conveys that the container and/or female non-luer connector include a non-luer connector.

Reference throughout this specification to "one embodiment," "certain embodiments," "one or more embodiments" or "an embodiment" means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. Thus, the appearances of the phrases such as "in one or more embodiments," "in certain embodiments," "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

Claim 1:
A non-luer connector for connection to a female non-luer connector comprising:
a container having an open distal end (<NUM>, <NUM>) including a distal wall (<NUM>, <NUM>, <NUM>), a sidewall (<NUM>, <NUM>) including an inside surface (<NUM>, <NUM>) defining a fluid chamber (<NUM>, <NUM>) for retaining fluids, an elongate tip (<NUM>) extending in a distal direction from the distal wall (<NUM>, <NUM>, <NUM>), the elongate tip (<NUM>) including an opening (<NUM>) for providing access to the chamber (<NUM>, <NUM>), and a non-luer element (<NUM>) disposed at the open distal end (<NUM>, <NUM>) causing leakage between a standard luer connector and the container when the standard luer connector is attached to the container;
wherein the non-luer element (<NUM>) includes a plurality of barrier walls (<NUM>) forming at least one aperture (<NUM>) spaced between the plurality of barrier walls (<NUM>);
characterized in that:
the non-luer element (<NUM>) has a distal end (<NUM>) and a proximal end (<NUM>), and the at least one aperture (<NUM>) extends from the distal end (<NUM>) of the non-luer element (<NUM>) to the proximal end (<NUM>) of the non-luer element (<NUM>) and wherein the non-luer element (<NUM>) extends in a distal direction from the distal wall (<NUM>, <NUM>, <NUM>) of the container and is disposed coaxially around the elongate tip (<NUM>), the non-luer element (<NUM>) forming a channel (<NUM>) between the elongate tip (<NUM>) and the non-luer element (<NUM>) for receiving a portion of the female non-luer connector and an inner cross-sectional dimension of the non-luer element (<NUM>) is greater than an inner cross-sectional dimension of a standard female luer connector and less than an outer cross-sectional dimension of the standard female luer connector;
wherein the at least one aperture (<NUM>) provides access to the channel (<NUM>)