Non-Luer Connector

Abstract

To provide a non-luer connector that prevents the formation of a fluid-tight seal between a standard female luer connector and a container. [Solution] The non-luer connector comprises: a container having an open distal end including a distal wall (518), a sidewall including an inner surface defining a fluid chamber for holding a fluid, and an elongated tip (532) extending distally from the distal wall, the elongated tip including an opening allowing access to the fluid chamber; and a non-luer element disposed in the open distal end that creates leakage between the standard luer connector and the container when the standard luer connector is attached to the container, the non-luer element including a plurality of barrier walls (552) spaced apart from each other to form at least one gap (557) allowing access to the channel, the non-luer element including a distal end and a proximal end, the at least one gap extending from the distal end of the non-luer element to the proximal end of the non-luer element.

Description

[Technical field]

[0001] An embodiment of the present invention relates to a non-luer connector for use in a drug delivery system that prevents misconnection with standard male and female luer connectors. [Background technology]

[0002] Connectors used in drug delivery devices typically share a common ISO standard luer connection. A standard luer tip or standard male connector has specifications as given by the International Organization for Standardization (ISO) in ISO 594-1:1986 and 594-2:1998, including an increasing 6% taper from the open distal end to the proximal end, and an outer cross-sectional diameter at the distal end of the tip that is between about 0.1545 inches (3.925 mm) and about 0.1570 inches (3.990 mm) for rigid materials and between about 0.1545 inches (3.925 mm) and about 0.1585 inches (4.027 mm) for semi-rigid materials. A standard luer hub or standard female luer connector may have a 6% taper decreasing from the open proximal end to the distal end and an inner cross-sectional dimension at the open proximal end that is between about 0.168 inches (4.270 mm) and about 0.170 inches (4.315 mm). In configurations of standard female luer connectors that incorporate tabs or protrusions for connecting to a corresponding male luer lock connector, the outer cross-sectional dimension of the standard female luer connector including the protrusions is within the range of about 0.307 inches (7.80 mm) to about 0.308 inches (7.83 mm). In the form of a standard female luer connector that does not incorporate a tab or protrusion for connection to a corresponding male luer lock connector, the outer cross-sectional dimensions may be about 0.224 inches (5.700 mm) for rigid connectors and about 0.265 inches (6.730 mm) for semi-rigid connectors, based on the maximum outer diameter of a standard female luer connector at the base of the protrusions per ISO 594-2. According to ISO 594-1, the minimum length of a standard luer tip and / or a standard luer hub is 0.295 inches (7.500 mm). As used herein, the phrases "standard male luer connector" and "standard female luer connector" refer to connectors having the above dimensions.

[0003] Standard Luer male and female connectors, collectively referred to herein as standard Luer connectors, are available for intravascular, anesthesia, and enteral delivery systems and may include structures that allow drug delivery devices to be compatible with one system to another. For example, some neuraxial drug delivery systems may use the same type of standard Luer connector as connectors used with other delivery applications, such as central venous catheters, central venous pressure parts, injection ports, balloon ports, introducer ports, IV Luer connectors, peritoneal dialysis catheters, distal ports for pulmonary artery catheters, and many other connectors. An unintended consequence of connecting a drug delivery system for one type of delivery system to a connector for use with another type of delivery system is that such a connection results in a coupling between two unrelated systems, i.e., neuraxial and intravenous (IV). Each delivery system is intended to provide a unique delivery method with a distinctly different purpose and different dosing method that may circumvent the interchangeability of known drug delivery systems. Such a circumvention may result in harm and / or serious injury to the patient.

[0004] It is one consensus accepted by device manufacturers and regulatory agencies to restrict the use of standard Luer connectors for vascular access or systems. Thus, there is a need to modify all other devices because the devices have different types of connectors that cannot physically connect to standard Luer connectors or non-compliant devices. Newly proposed standards for small bore connectors, such as ISO 80369-6 for neuraxial applications, have also promoted the need for suitable non-Luer connectors. These proposed new codes include connectors with a 5% taper instead of the 6% taper currently used for standard Luer connectors. In addition, the new codes propose connectors with smaller inner and outer cross-sectional dimensions than standard Luer connectors, and longer lengths than standard Luer connectors. Summary of the Invention [Problem to be solved by the invention]

[0005] Attempts to prevent or minimize misconnections between drug delivery systems include educating practitioners about misconnections, labeling, and color coding. However, these attempts only provide a temporary solution. The use of adapters to provide removable non-luer adapters also does not provide a permanent solution that eliminates or reduces human error. Another solution is the use of adapters to allow users to fill the drug delivery system with the medication to be dispensed, as the drug delivery system does not fit into a standard ampoule, vial, or other container.

[0006] There is a need for a non-Luer connector for use with drug delivery systems that prevents misconnections with standard Luer connectors and other unintended drug delivery systems. [Means for solving the problem]

[0007] In this disclosure, the convention followed is that the distal end of the device is the end closest to the patient, and the proximal end of the device is the end both farther away from the patient and closest to the practitioner.

[0008] As used herein, the term "dimension" shall include the length, diameter, or width of a geometric shape or component of a geometric shape described herein. The term "cross-sectional dimension" shall include the measurement of the longest or greatest distance between two points on the edge of a cross-section of an object or component having a circular or non-circular cross-section. The two points may be located on the inner or outer surface of the cross-section edge of the object. The cross-sectional dimension of two points located on the inner surface of the cross-section edge of the object shall be referred to as the "inner cross-sectional dimension" and the cross-sectional dimension of two points located on the outer surface of the cross-section edge of the object shall be referred to as the "outer cross-sectional dimension". It should be recognized that the "cross-sectional dimension" of an object having a circular cross-section may be referred to as the "diameter" of the object. For objects having a circular cross-section, the terms "cross-sectional dimension" and "diameter" may be used interchangeably.

[0009] The drug delivery system of one or more embodiments described herein can be used in neuraxial drug delivery applications, anesthetic drug delivery applications, intravascular drug delivery applications, or other drug delivery applications.

[0010] A first aspect of the present invention relates to a male non-luer connector for connecting to a female non-luer connector. In one or more embodiments, the non-luer connector includes a container having an open distal end including a distal wall and a sidewall extending proximally from the distal wall. The sidewall includes an inner surface defining a fluid chamber for holding a fluid. The container also includes an elongated tip extending distally from the distal wall. The elongated tip includes an opening for allowing access to the chamber, an outer surface, and a distal end.

[0011] In one or more embodiments, the exterior surface of the elongate tip has an outer cross-sectional dimension of 0.1545 inches (3.925 mm) or less, measured at the distal end of the tip. In one or more specific embodiments, the outer cross-sectional dimension of the elongate tip, measured at the distal end of the tip, is within the range of about 0.100 inches (2.540 mm) to about 0.145 inches (3.683 mm). In even more specific embodiments, the outer cross-sectional dimension of the elongate tip, measured at the distal end of the tip, is within the range of about 0.1306 inches (3.317 mm) to about 0.1326 inches (3.368 mm).

[0012] The elongate tip of one or more embodiments may have a length within the range of about 0.200 inches (5.080 mm) to about 0.500 inches (12.70 mm) measured from the distal wall of the container to the distal end of the elongate tip.

[0013] The outer surface of the elongate tip may have a taper that decreases from a proximal direction to a distal direction of less than 6%. In one or more specific embodiments, the taper of the outer surface may be in the range of about 3% to about 5.9%.

[0014] In one or more embodiments, the outer surface of the elongate tip may have a taper of greater than 6% decreasing in a proximal to distal direction.

[0015] The non-luer connector of one or more embodiments may further comprise a female non-luer connector removably attached to the elongate tip of the container. In one or more embodiments, the female non-luer connector includes a hub body having an open proximal end and an interior surface defining a cavity. The hub body may optionally include a needle cannula attached to the hub body. The needle cannula may include an open proximal end in fluid communication with an opening of the container.

[0016] In one or more embodiments, the hub body cavity may have an inner cross-sectional dimension measured at the open proximal end of less than 0.168 inches (4.270 mm). In one or more specific embodiments, the hub body cavity may have an inner cross-sectional dimension at the proximal end within a range of about 0.110 inches (2.794 mm) to about 0.150 inches (3.810 mm). In still further specific embodiments, the hub body cavity may have an inner cross-sectional dimension measured at the open proximal end within a range of about 0.1417 inches (3.599 mm) to about 0.1437 inches (3.650 mm).

[0017] The cavity of one or more embodiments of the female non-luer connector may be within the range of about 0.250 inches (6.350 mm) to about 0.500 inches (12.70 mm) in length.

[0018] In one or more embodiments, the interior surface of the cavity has a taper decreasing from the proximal to the distal direction of less than 6%. In one or more specific embodiments, the interior surface of the cavity has a taper decreasing from the proximal to the distal direction of within a range of about 3% to about 5.9%, or alternatively within a range of about 0.5% to about 2.9%.

[0019] In one or more embodiments, the interior surface of the cavity has a taper that decreases from the proximal to the distal direction of greater than 6%.

[0020] In one or more embodiments, the elongated tip of the container may have a square cross-sectional shape. In one or more specific embodiments, the outer surface of the elongated tip may have 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 elongated tip, or more specifically, the outer surface of the elongated tip. In one or more alternative embodiments, the elongated 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 elongated 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 outer surface of the elongated tip.

[0021] A second aspect of the invention relates to a non-luer connector for connection to a female non-luer connector comprising a non-luer element. In one or more embodiments, the non-luer connector comprises a container having an open distal end including a distal wall and a sidewall extending distally from the distal wall. The sidewall may include an inner surface defining a fluid chamber for holding a fluid. The container may also comprise an elongated tip extending distally from the distal wall. The elongated tip includes an opening that allows access to the chamber. In one or more embodiments, the non-luer element is disposed at the open distal end of the container to prevent a liquid-tight connection between the container and a standard luer connector.

[0022] In one or more embodiments, the elongate tip may comprise an exterior surface on which the non-luer element is disposed. One or more variations of the non-luer element may comprise an exterior surface having an exterior cross-sectional dimension that is greater than the exterior cross-sectional dimension of the elongate tip. The exterior cross-sectional dimension of the non-luer element may also be greater than the interior cross-sectional dimension of a standard female luer connector. The exterior cross-sectional dimension of the non-luer element may prevent connection of the elongate tip with a standard female luer connector. 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.

[0023] An embodiment of a non-luer connector according to the second aspect may comprise a female non-luer connector that is removably attached to an elongate tip of a container, as otherwise described herein. In one or more embodiments, the female non-luer connector may have a cavity having cross-sectional dimensions selected to form a fluid-tight seal with the elongate tip, or more specifically, an exterior surface of the tip.

[0024] In one or more embodiments, the non-luer element extends distally from the distal wall of the container. The non-luer element may be coaxially disposed around the elongated tip and form a channel between the elongated tip and the non-luer element that receives a portion of the female non-luer connector. In one or more variations, the non-luer element may have an inner cross-sectional dimension that is greater than the inner cross-sectional dimension of the standard female luer connector and less than the 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 of one or more embodiments may include at least one gap that allows access to and from the channel. In one variation, the non-luer element includes at least two gaps and includes a curved cross-sectional shape between the two gaps. In another variation, the non-luer element comprises a distal end and a proximal end, and at least one or two gaps extend from the distal end of the non-luer element to the proximal end of the non-luer element. In yet another variation, at least one or two gaps extend from the distal end partially between the distal end of the non-luer element and the proximal end of the non-luer element for a distance. The one or more gaps provided in one or more embodiments may provide a 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 at least one gap having dimensions selected to prevent the formation of a fluid-tight seal between the non-luer element and a standard female luer connector. In one variation, the distal end of the non-luer element extends distally past the elongated tip. In another variation, the elongate tip includes a distal end that extends distally past the distal end of the non-luer connector.

[0025] In one or more embodiments in which the non-luer element is coaxially disposed about the elongate tip, the non-luer connector may comprise a female non-luer connector that is 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 a fluid-tight connection of the female non-luer connector with the elongate tip. In one or more embodiments, the cavity of the female non-luer connector may have cross-sectional dimensions selected to form a fluid-tight seal with the elongate tip.

[0026] In one or more embodiments, the non-luer element may be provided on the non-luer connector at the distal end of the elongate tip. The non-luer element may be disposed at the distal end of the elongate tip to prevent 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 comprise a body wall having an outer surface extending from the distal end to a distal wall of the container, and the non-luer element comprises a notch in fluid communication with an opening of the elongate tip that extends across the distal end of the elongate tip to the outer surface of the body wall of the elongate tip. In one or more specific embodiments, the non-luer element comprises a plurality of notches disposed at the distal end of the elongate tip. The plurality of notches may be disposed adjacent to one another along a circumference of the distal end of the tip and may surround the opening of the tip. In one or more variations, the plurality of notches have a wedge shape extending to 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 exterior surface of the tip. In one or more embodiments, the exterior surface of the elongate tip has a taper that decreases by 5% in the proximal to distal direction. The tip may also have an outer cross-sectional dimension that is sized to prevent connection of a standard female Luer connector to a container.

[0027] As another embodiment of the non-luer connector comprising a notch, the one or more notches may comprise a female non-luer connector removably attached to the elongate tip, as described above. The female non-luer connector may comprise an interior surface defining a cavity dimensioned for a fluid-tight connection between the female non-luer connector and the elongate tip. In one or more embodiments, when the female non-luer connector is attached to the container, the notch may contact 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, when the standard female luer connector is attached to the container, the notch is disposed at a distance from the interior surface of the standard female luer connector to prevent the 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 5% taper decreasing from the proximal to the distal direction. In one or more alternative embodiments, the non-luer element may further comprise at least one gap allowing access to and from the channel.

[0028] A third aspect of the invention relates to a drug delivery device comprising a container and a female non-luer connector. In one or more embodiments, the container comprises an open distal end including a distal wall, and a sidewall extending proximally from the distal wall. The sidewall comprises an inner surface defining a fluid chamber for holding a fluid. The elongate tip is disposed on the distal wall and extends distally from the distal wall. The elongate tip comprises an opening allowing access to the chamber, and an inner surface including a taper of less than 6% decreasing from the proximal to the distal direction. The elongate tip can have an outer cross-sectional dimension sized to prevent connection of the container with a standard female luer connector. The female non-luer connector may comprise a hub body including an open proximal end, and an inner surface defining a cavity. The inner surface of the hub body may have a taper of less than 6% decreasing from the proximal to the distal direction. The cavity may have an inner cross-sectional dimension sized to prevent connection of the female non-luer connector with a standard female luer connector. The hub body may optionally include a needle cannula attached thereto, the needle cannula including an open distal end in fluid communication with the opening of the container.

[0029] The drug delivery device of one or more embodiments may include a visible indication that provides an indication that a fluid-tight seal is formed between the female non-luer connector and the container and that the needle cannula is in fluid communication with the opening of the container. [Brief description of the drawings]

[0030] [Figure 1] FIG. 1 is a perspective view of a syringe barrel having a standard male Luer connector according to the prior art. [Diagram 2] FIG. 2 is a cross-sectional side view of the syringe barrel and standard male luer connector of FIG. 1. [Diagram 3] FIG. 3 is an enlarged view of the standard male luer connector of FIG. 2. [Figure 4] FIG. 1 is a cross-sectional side view of a needle hub having a standard female Luer connector according to the prior art. [Diagram 5] FIG. 1 is a perspective view of a female non-luer connector according to one or more embodiments of the present invention. [Figure 6] FIG. 6 is a perspective view from the proximal end of the non-luer hub shown in FIG. [Figure 7] FIG. 6 is a side elevational view of the female non-luer connector shown in FIG. 5. [Figure 8] FIG. 8 is a side elevational view of the female non-luer connector shown in FIG. 7 after rotating the connector 90 degrees. [Figure 9] FIG. 8 is a front elevational view of the female non-luer connector shown in FIG. [Figure 10] FIG. 8 is a rear elevational view of the female non-luer connector shown in FIG. [Figure 11] FIG. 11 is a cross-sectional view of the female non-luer connector shown in FIG. 7 taken along line 11-11. [Figure 12] FIG. 12 is a perspective view of the female non-luer connector shown in FIG. 11 from the proximal end. [Figure 13] FIG. 12 is a perspective view of the female non-luer connector shown in FIG. 11 from the distal end. [Figure 14] FIG. 2 is a perspective view from a proximal end of a container according to one or more embodiments of the present invention. [Figure 15] FIG. 15 is a perspective view from the distal end of the container shown in FIG. [Figure 16] FIG. 15 is a side elevational view of the container shown in FIG. [Figure 17] FIG. 17 is a side elevational view of the container shown in FIG. 16 after rotating the container 90 degrees. [Figure 18] FIG. 17 is a rear elevational view of the container shown in FIG. 16. [Figure 19] FIG. 17 is a front elevational view of the container shown in FIG. [Figure 20] 20 is a cross-sectional view of the container shown in FIG. 17 taken along line 20-20. [Figure 21] FIG. 18 is a perspective view of the container shown in FIG. 17 from the proximal end. [Figure 22] FIG. 18 is a perspective view of the container shown in FIG. 17 from the distal end. [Figure 23] FIG. 2 is a perspective view from a distal end of a container according to one or more embodiments of the present invention. [Figure 24] FIG. 24 is a rear elevational view of the container shown in FIG. 23. [Diagram 25] FIG. 24 is a front elevational view of the container shown in FIG. 23. [Figure 26] FIG. 26 is an enlarged, partial cross-sectional view of the container shown in FIG. 23 taken along line 26-26. [Figure 27] FIG. 27 is a perspective view of the container shown in FIG. 26 from the proximal end. [Figure 28] FIG. 27 is a perspective view of the container shown in FIG. 26 from the distal end. [Figure 29A] FIG. 2 is a partial perspective view from a distal end of a container according to one or more embodiments of the present invention. [Figure 29B] FIG. 2 is a partial perspective view from a distal end of a container according to one or more embodiments of the present invention. [Figure 29C] FIG. 2 is a partial perspective view from a distal end of a container according to one or more embodiments of the present invention. [Figure 29D] FIG. 2 is a partial perspective view from a distal end of a container according to one or more embodiments of the present invention. [Figure 29E] FIG. 2 is a partial perspective view from a distal end of a container according to one or more embodiments of the present invention. [Diagram 30] FIG. 30 is a rear elevational view of the container shown in FIG. 29. [Diagram 31] FIG. 30 is a front elevational view of the container shown in FIG. [Diagram 32] FIG. 32 is an enlarged, partial cross-sectional view of the container shown in FIG. 29 taken along line 32-32. [Diagram 33] FIG. 38 is a perspective view of the container shown in FIG. 37 from the proximal end. [Diagram 34] FIG. 34 is an enlarged fragmentary view of the distal end of the container of FIG. 33. [Diagram 35] FIG. 2 is a partial perspective view from a distal end of a container according to one or more embodiments of the present invention. [Diagram 36] FIG. 36 is a partial side elevational view of the container shown in FIG. 35. [Figure 37] FIG. 36 is a rear elevational view of the container shown in FIG. 35. [Figure 38]FIG. 36 is a front elevational view of the container shown in FIG. [Figure 39] FIG. 39 is an enlarged, partial cross-sectional view of the container shown in FIG. 36 taken along line 39-39. [Diagram 40] FIG. 40 is a perspective view of the container shown in FIG. 39 from the proximal end. [Diagram 41] FIG. 40 is a perspective view of the container shown in FIG. 39 from the distal end. [Diagram 42] FIG. 1 is a perspective view of a container according to one or more embodiments of the present invention. [Diagram 43] FIG. 43 is an enlarged partial side elevational view of the container shown in FIG. 42. [Diagram 44] FIG. 44 is a side elevational view of the container shown in FIG. 43 after rotating the container 90 degrees. [Diagram 45] FIG. 43 is a rear elevational view of the container shown in FIG. [Figure 46] FIG. 43 is a front elevational view of the container shown in FIG. [Figure 47] FIG. 47 is a cross-sectional view of the container shown in FIG. 44 taken along line 47-47. [Figure 48] FIG. 48 is a perspective view of the container shown in FIG. 47 from the distal end. [Figure 49] FIG. 2 is an enlarged, partial perspective view from a distal end of a container according to one or more embodiments of the present invention. [Figure 50] FIG. 50 is an enlarged partial side elevational view of the container shown in FIG. 49. [Figure 51] FIG. 51 is a side elevational view of the container shown in FIG. 50 after rotating the container 90 degrees. [Figure 52] FIG. 51 is a rear elevational view of the container shown in FIG. 50. [Figure 53] FIG. 51 is a front elevational view of the container shown in FIG. [Figure 54] 54 is a cross-sectional view of the container shown in FIG. 50 taken along line 54-54. [Figure 55] FIG. 55 is a perspective view of the container shown in FIG. 54 from the proximal end. [Figure 56] FIG. 55 is a perspective view of the container shown in FIG. 54 from the distal end. [Figure 57]FIG. 2 is an enlarged, partial perspective view from a distal end of a container according to one or more embodiments of the present invention. [Figure 58] FIG. 58 is a side elevational view of the container shown in FIG. [Figure 59] FIG. 58 is a rear elevational view of the container shown in FIG. 57. [Figure 60] FIG. 58 is a front elevational view of the container shown in FIG. [Figure 61] FIG. 61 is an enlarged partial cross-sectional view of the container shown in FIG. 58 taken along line 61-61. [Figure 62] FIG. 62 is an enlarged, partial perspective view of the container shown in FIG. 61 from the distal end. [Figure 63] FIG. 63 is an enlarged partial view of the tip of the container shown in FIG. 62. [Figure 64] FIG. 1 shows a diagram comparing existing ISO standards for standard Luer connectors according to the prior art with proposed standards for male and female connectors for neuraxial applications. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] Before describing some example embodiments of the invention, it is to be understood that the invention is not limited to the details of construction or process steps set forth in the following description as the invention is capable of other embodiments and of being practiced or carried out in various ways.

[0032] Aspects of the present invention relate to non-luer connectors that prevent misconnection with other incompatible or unintended standard luer connectors. As used herein, a non-luer connector shall be defined as a connector having a shape, dimension or structure different from a standard luer connector, as described above. A non-luer connector shall also include a connector having a shape, dimension or structure that is not characterized or defined as a luer connector as defined above or according to ISO594-1:1986 or ISO594-2:1998. In one or more specific embodiments, a non-luer connector has a length and / or cross-sectional dimension different from a luer connector as defined above or according to ISO594-1:1986 or ISO594-2:1998. In further specific embodiments, a non-luer connector has a taper different from a luer connector as defined above or according to ISO594-1:1986 or ISO594-2:1998. In still further specific embodiments, the non-luer connector has a more gradual taper than a luer connector as defined above or according to ISO 594-1:1986 or ISO 594-2:1998, a smaller cross-sectional dimension than a luer connector as defined above or according to ISO 594-1:1986 or ISO 594-2:1998, and a longer length than a luer connector as defined above or according to ISO 594-1:1986 or ISO 594-2:1998. Specifically, the non-luer connector embodiments described herein incorporate features that prevent the connection of a standard luer connector with a non-luer connector. As used herein, a standard luer connector can include a needle hub, syringe or other delivery component that incorporates a standard luer connector. Exemplary standard luer connectors are shown in Figures 1-4. Figure 1 shows a syringe barrel 100 having a distal end 111 and a proximal end 119. Syringe barrel 100 includes a sidewall 112 extending from a distal end 111 to a proximal end 119 and includes an inner surface 114 that defines a chamber 116 for holding a fluid. Syringe barrel 100 also includes a distal wall 118 adjacent distal end 111 and a flange 120 disposed at the proximal end 119 of the syringe barrel.Luer connector 121 is provided in the form of an open tip 122 with a passageway 124 extending from distal wall 118 and in fluid communication with chamber 116. Tip 122 includes an exterior surface 126 that defines an outer cross-sectional dimension and length that is typical of a standard male Luer connector.

[0033] FIG. 4 illustrates an exemplary standard needle hub 130 having a standard female luer connector. The needle hub 130 includes an open distal end 131 and an open proximal end 139. A hub body 132 extends from the distal end 131 to the proximal end 139. In the illustrated embodiment, the luer connector 133 is provided in the form of the hub body 132 including an inner surface 134 that defines a cavity 136. The cavity 136 is sized and shaped to allow for fluid-tight engagement with the tip 122 of the syringe barrel. The needle hub 130 illustrated in FIG. 4 also includes a needle cannula 140 attached to the open distal end 111. The needle cannula 140 includes an open distal end 142 that is in fluid communication with the cavity 136. The inner surface 134 of the hub body 132 has an inner cross-sectional dimension and length that is typical of a standard female luer connector.

[0034] Both the standard luer connector of the syringe barrel 100 and the standard luer connector of the needle hub 130 are sized and shaped to form an interference fit connection and / or fluid tight engagement with one another. Specifically, the outer surface of the tip 122 has a taper, length and shape that is typical of a standard male luer connector that allows the tip 122 to form an interference fit connection with the inner surface of the needle hub 130, as described above, and the inner surface of the needle hub 130 also has a taper, length and shape that is typical of a standard female luer connector, as also described above. In one or more alternative embodiments, the syringe barrel 100 can include a standard male luer connector in the form of a luer lock connector (not shown), which includes a threaded portion that engages with a cooperating structure of the needle hub 130, such as an outwardly extending tab 138, as shown in FIG. 4, to attach the needle hub 130 to the syringe barrel 100.

[0035] A first aspect of the invention relates to a non-luer connector having dimensions and / or shapes or incorporating features that prevent connection of the non-luer connector to a standard luer connector. A second aspect of the invention includes a non-luer connector that utilizes a non-luer element to prevent connection to a standard luer connector. A third aspect of the invention includes a non-luer connector that prevents the formation of a liquid-tight connection between the non-luer connector and a standard luer connector, thereby allowing leakage or increasing the likelihood of liquid leakage in the connection.

[0036] 5-13 show one or more embodiments of a female non-luer connector 200 that can be utilized as part of a drug delivery device according to the first, second and third aspects of the present invention. Specifically, the female non-luer connector 200 comprises a non-luer portion 230 that can be attached to a non-luer connector of a container, which will be described below.

[0037] The female non-luer connector 200 comprises an open distal end 201 and an open proximal end 209. The female non-luer connector 200 also comprises a non-luer portion 230 for forming an interference fit connection with a corresponding non-luer connector. The non-luer portion 230 is an integral component of the female non-luer connector 200 and, in the embodiment shown in Figures 5-13, is provided as a wall 212 extending distally from the open proximal end 209 of the female non-luer connector 200. The wall 212 comprises an inner surface 214 defining a cavity 216 for receiving at least a portion of a corresponding non-luer connector. The female non-luer connector 200 comprises an outer surface 203 having a radially outwardly extending rim 218 disposed along the entire circumference of the outer surface 203 at the distal end 201 of the female non-luer connector 200. The rim 218 in the embodiment shown in Figures 5-13 includes a radially outwardly extending tab 220 disposed along at least a portion of the rim 218 for engaging a corresponding non-luer connector including a locking feature or threaded component. The tab 220 may include two tapered ends to facilitate engagement with the locking feature or threaded component. The rim 218 includes an inner surface 219 having a cross-sectional diameter larger than the cross-sectional diameter of the remainder of the female non-luer connector 200.

[0038] The inner surface 214 of the wall 212 has a size and / or shape that allows for engagement or attachment of the female non-luer connector 200 with another corresponding non-luer connector. As described below, the corresponding non-luer connector includes an outer surface having an outer cross-sectional dimension that is smaller or larger than the inner cross-sectional dimension measured at the inner surface 134 of the standard female luer connector. However, the outer cross-sectional dimension of the corresponding non-luer connector is sized and / or shaped to properly engage the inner surface 214 of the female non-luer connector 200 shown in Figures 5-13 to provide a fluid-tight connection.

[0039] In one or more embodiments, the inner surface 214 of the wall 212 may be shaped to form a fluid-tight engagement with a corresponding non-luer connector having a non-circular cross-section. Specifically, the inner surface 214 of the wall 212 can have a square, triangular, or other non-circular cross-section that allows for the formation of an interference fit connection and / or fluid-tight engagement with a non-luer connector having an outer surface with a square, triangular, or other non-circular cross-section.

[0040] In addition, the inner surface 214 of the wall 212 has a dimension and / or shape that prevents engagement of the female non-luer connector 200 with a standard male luer connector. Specifically, the inner surface 214 of the wall 212 can 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, a tip 122 having an outer surface 126 with a circular cross-section. In embodiments in which the inner cross-sectional dimensions of the wall 212 are sized to allow the tip 122 or a standard male connector of a typical luer connector to be disposed within the cavity 216, the non-circular cross-sectional shape of the wall 212 at the inner surface 214 prevents sufficient contact between the outer surface 126 of the tip, thereby preventing the formation of an interference fit connection and / or fluid tight engagement therebetween. In one or more embodiments, the inner cross-sectional dimension of wall 212 may be larger than the outer cross-sectional dimension of tip 122 or other standard male luer connector, thereby still preventing sufficient contact between the tip or other luer connector's outer surface 126, thereby preventing the formation of an interference fit connection and / or fluid-tight engagement therebetween.

[0041] In the illustrated embodiment, the attachment end 210 also includes a first narrowed wall 222 extending from the wall 212 to a second narrowed wall 224 disposed distally adjacent the first narrowed wall 222. A third narrowed wall 226 is disposed distally adjacent the second narrowed wall 224 and extends to the proximal end 209 of the female non-luer connector 200. The first narrowed wall 222 has an inner cross-sectional dimension that is less than the inner cross-sectional dimension of the wall 212 measured at the inner surface of the wall 212. The first narrowed wall 222 can have a tapered, i.e., decreasing, inner cross-sectional dimension in the distal direction. The inner cross-sectional dimension or shape of the first narrowed wall 222 can also prevent attachment of the female non-luer connector 200 to a standard male luer connector.

[0042] The second narrowed wall 224 has an inner cross-sectional dimension that is smaller than the inner cross-sectional dimension of the first narrowed wall 222 and the inner cross-sectional dimension of the wall 212. As shown in FIG. 11, the second narrowed wall 224 can have a taper, where the inner cross-sectional dimension of the taper decreases in a distal direction. In the embodiment shown in FIG. 11, the taper, i.e., the decrease in the inner cross-sectional dimension, of the second narrowed wall 224 is severe or dramatic. In one or more alternative embodiments, the taper, i.e., the decrease in the inner cross-sectional dimension, of the second narrowed wall 224 can be gradual and / or the second narrowed portion can have a constant inner cross-sectional dimension. The third narrowed wall 226 has an inner cross-sectional dimension that is smaller than the inner cross-sectional dimension of the wall 212, the first narrowed wall 222, and the second narrowed wall 224. The third narrowed wall 226 can have a constant inner cross-sectional dimension or, as shown in Figure 11, comprises a proximal portion having a tapered inner cross-sectional dimension that decreases in a distal direction and a distal portion having a constant inner cross-sectional dimension. The third narrowed wall 226 is shaped and sized to support a needle cannula within the cavity 216 that extends from the open proximal end 209 of the female non-luer connector, including from wall 212 to the third narrowed wall 226, to the open distal end of the hub.

[0043] In one or more embodiments, the cavity 216 has an inner cross-sectional dimension measured at the proximal end 209 of 0.168 inches (4.270 mm). In one or more specific embodiments, the cavity 216 has an inner cross-sectional dimension measured at the proximal end 209 within the range of about 0.100 inches (2.540 mm) to about 0.1600 inches (4.064 mm), or more specifically within the range of about 0.1300 inches (3.302 mm) to about 0.1500 inches (3.810 mm). In still further specific embodiments, the cavity 216 has an inner cross-sectional dimension measured at the proximal end 209 within the range of about 0.1417 inches (3.599 mm) to about 0.1437 inches (3.650 mm). The lower limits of the inner cross-sectional dimension of the cavity 216 at the proximal end 209 may include 0.1400 inches (3.556 mm), 0.1404 inches (3.566 mm), 0.1408 inches (3.576 mm), 0.1412 inches (3.586 mm), and 0.1416 inches (3.597 mm). The upper limits of the inner cross-sectional dimension of the cavity 216 at the proximal end 209 may include 0.1439 inches (3.655 mm), 0.1443 inches (3.665 mm), 0.1447 inches (3.675 mm), 0.1451 inches (3.686 mm), and 0.1455 inches (3.696 mm). In one or more embodiments, the inner cross-sectional dimension of cavity 216 can be within the range of about 0.100 inches (2.540 mm) to about 0.119 inches (3.023 mm), about 0.130 inches (3.302 mm) to about 0.139 inches (3.531 mm), about 0.140 inches (3.556 mm) to about 0.149 inches (3.785 mm), about 0.150 inches (3.810 mm) to about 0.159 inches (4.039 mm), or about 0.159 inches (4.039 mm) to about 0.167 inches (4.242 mm).

[0044] In one or more embodiments, the inner surface 214 of the wall 212 may have a taper of less than 6% decreasing in the proximal to distal direction, i.e., an inner cross-sectional dimension decreasing from the proximal end 209 to the distal end 201 at a rate of less than 6%. In one or more specific embodiments, the inner surface 214 of the wall 212 has a taper decreasing in the proximal to distal direction within a range of about 3% to about 5.9%. In one or more embodiments, the taper of the inner surface 214 of the wall 212 may be within a range of about 0.5% to about 2.9% decreasing in the proximal to distal direction. In certain embodiments, the taper of the inner surface 214 of the wall 212 is about 5% decreasing in the proximal to distal direction. Lower limits of the taper of the inner surface 214 of the wall 212 decreasing in the proximal to distal direction may include 4.2%, 4.4%, 4.6%, 4.8%. The upper limit of the taper of the inner surface 214 of the wall 212 decreasing in the proximal to distal direction may include 5.2%, 5.4%, 5.6%, 5.8%. In one or more embodiments, the inner surface 214 of the wall 212 may have a taper decreasing in the proximal to distal direction of greater than 6%, i.e., an inner cross-sectional dimension that decreases from the proximal end 209 to the distal end 201 at a rate of greater than 6%.

[0045] In one or more embodiments, the length of cavity 216 measured from proximal end 209 to the end of second narrowed wall 224 (but not including second narrowed wall) can be within a range of about 0.200 inches (5.080 mm) to about 0.500 inches (12.70 mm). In more specific embodiments, the length of cavity 216 measured from proximal end 209 to the end of second narrowed wall 224 (but not including second narrowed wall) can be within a range of about 0.295 inches (7.500 mm) to about 0.400 inches (10.16 mm). In yet more specific embodiments, the length of cavity 216 can be about 0.303 inches (7.696 mm).

[0046] The outer surface 203 of the female non-luer connector comprises at least one arm extending from the first narrowed wall 222 to a position adjacent the open distal end 201 of the hub. In the embodiment shown in Figures 5-13, the female non-luer connector 200 comprises two arms 231, 232 disposed on either side of the female non-luer connector 200 and extending from the first narrowed wall 222 to a position adjacent the open distal end 201. The arms 231, 232 define spaces 234, 236 between the outer surface 203 of the female non-luer connector and the arms 231, 232. The arms 231, 232 provide a finger gripping area or gripping surface upon which the female non-luer connector 200 is gripped during use. The arms 231, 232 can have any shape known to provide such finger gripping areas. In one or more alternative embodiments, the female non-luer connector 200 may be devoid of any structure on its outer surface 203.

[0047] Adjacent to the open distal end 201, the female non-luer connector comprises an annular disc 240 disposed adjacent to two arms 231, 232 extending radially outward from the outer surface 203 of the hub. Four individual projections 243, 244, 245, 246 extend radially outward from the outer surface 203 and along the same axis from the annular disc 240 to the open distal end 201. As shown in Figures 11 and 12, the four individual projections 243, 244, 245, 246 are located along the third narrowed wall 226.

[0048] 6, the rim 218 can include an indentation for use with a stylet and spinal needle. In one or more alternative embodiments, the indentation provides a needle bevel orientation indicator where the indentation is aligned with the bevel of a needle cannula.

[0049] Figures 14-22 show one or more embodiments of a non-luer connector for use in a drug delivery device according to the first aspect of the present invention. Figures 14-22 show a non-luer connector 300 including a non-luer portion 330 for attachment to another non-luer connector, for example the female non-luer connector 200 described above. The non-luer connector 300 of Figures 14-22 is shown integrally formed to a container in the form of a syringe barrel 310. The container may be provided in other forms, for example in a medicine bag, an epidural pump, and other containers known in the art. The syringe barrel 310 shown in Figures 14-22 comprises a distal end 311, an open proximal end 319, and a sidewall 312 extending from the distal end 311 to the open proximal end 319. The sidewall 312 includes an inner surface 314 that defines a chamber 316 for holding a fluid, which may include a liquid medicament and / or other liquid. The open proximal end 319 may include an option flange 320, and the distal end 311 includes a distal wall 318. A non-luer portion 330 is integrally formed or provided within the container. Specifically, in the embodiment shown in Figures 14-22, the non-luer portion 330 is provided in the form of a tip 332 that extends distally from the distal wall 318 and includes an opening 334. The tip 332 extends from the distal wall 318 to a distal end 333 of the tip. The tip 332 includes an outer surface 338 and an inner surface 340 that defines a passageway 342 that allows fluid communication between the chamber 316 and the opening 334.

[0050] In the illustrated embodiment, the tip 332 has a size and / or shape that prevents connection to a standard female luer connector, such as the needle hub 130 and syringe barrel 310 shown in FIG. 4. Specifically, the non-luer portion 330 has a square cross-section and / or outer cross-sectional dimensions that do not fit into typical luer connectors having a circular cross-section and / or smaller or larger outer cross-sectional dimensions. In the illustrated embodiment, the tip 332 is shown in the form of four separate walls 343, 344, 345, 346 that are connected to form an enclosure around a passageway 342 of the tip 332 having a square cross-section. In one or more embodiments, the outer cross-sectional dimension of the tip 332 measured from the outer surface 338 of the tip 332 at the intersection of the walls 343 and 346 and the intersection of the walls 345 and 344 is greater than the inner cross-sectional dimension of the inner surface 134 of the hub body 132 of the luer connector 133 of the needle hub 130. Thus, the hub body 132 can fit or slide over the tip 332 such that the tip 332 is disposed within the cavity 136, and the inner surface 134 of the hub body 132 cannot form an interference fit connection and / or fluid tight engagement with the outer surface 338 of the tip 332. Thus, the non-luer portion 330 prevents connection of a standard female luer connector, such as the luer connector 133 of the needle hub 130. As described below, the non-luer portion 330 has a size and / or shape that allows connection to another corresponding non-luer connector.

[0051] In one or more alternative embodiments, the tip 332 can 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 332 prevents contact between the inner surface 134 of the luer connector and the outer surface 338 of the tip sufficient to form an interference fit connection and / or fluid-tight engagement therebetween.

[0052] In one or more embodiments, even if the inner surface 134 of the hub body 132 has an inner cross-sectional dimension large enough to allow the hub body 132 to slide over the outer surface 338 of the tip 332 such that the tip 332 is disposed within the cavity 136, the square cross-section of the tip 332 prevents the inner surface 134 of the hub body 132 from making sufficient contact with the outer surface 338 of the tip 332 to form an interference fit connection and / or a fluid-tight seal with the outer surface 338 of the tip 332. This is because the inner surface 134 is curved and does not contact the outer surface 338 of the tip 332. In other words, the corners of the tip 332 having a square cross-section do not contact the inner surface of a hub having a circular cross-section, e.g., needle hub 130. In one or more alternative embodiments, tip 332 may have a triangular cross-section or other cross-section that prevents sufficient contact with the inner surface of a standard female luer connector, such as inner surface 134 of luer connector 133, thereby preventing the formation of an interference fit connection and / or fluid-tight seal therebetween.

[0053] The tip 332 may also have a length that prevents the formation of an interference fit connection and / or fluid tight engagement with a standard female Luer connector. Specifically, the length of the tip 332 may be too long or too short to allow the respective tapers of the tip 332 and the inner surface 134 of the Luer connector to align to form an interference fit connection and / or fluid tight engagement therebetween.

[0054] In one or more embodiments, the tip 332 has an outer cross-sectional dimension at the distal end 333 of 0.1545 inches (3.925 mm) or less. In more specific embodiments, the tip 332 has an outer cross-sectional dimension at the distal end 333 within the range of about 0.1200 inches (3.048 mm) to about 0.1500 inches (3.810 mm), or more specifically within the range of about 0.1300 inches (3.302 mm) to about 0.1400 inches (3.556 mm). In even more specific embodiments, the tip 332 may have an outer cross-sectional dimension at the distal end 333 within the range of about 0.1306 inches (3.317 mm) to about 0.1326 inches (3.368 mm). In one or more specific embodiments, the outer cross-sectional dimension of the tip 332 at the distal end 333 is within the range of about 0.100 inches (2.540 mm) to about 0.119 inches (3.023 mm), about 0.120 inches (3.048 mm) to about 0.129 inches (3.277 mm), about 0.130 inches (3.302 mm) to about 0.139 inches (3.531 mm), about 0.140 inches (3.556 mm) to about 0.149 inches (3.785 mm), or about 0.150 inches (3.810 mm) to about 0.154 inches (3.912 mm). The upper limits of the outer cross-sectional dimension of tip 332 at distal end 333 can include 0.1328 inches (3.373 mm), 0.1330 inches (3.378 mm), 0.1332 inches (3.383 mm), 0.1334 inches (3.388 mm), 0.1336 inches (3.393 mm), and 0.1338 inches (3.399 mm). The lower limits of the outer cross-sectional dimension of the tip 332 at the distal end 333 can include 0.1304 inches (3.312 mm), 0.1302 inches (3.307 mm), 0.1298 inches (3.297 mm), 0.1296 inches (3.292 mm), 0.1294 inches (3.287 mm), 0.1292 inches (3.282 mm), and 0.1290 inches (3.277 mm).

[0055] In one or more embodiments, the outer surface 338 of the tip 332 may have a taper that decreases from the proximal to distal direction of less than 6%, i.e., an outer cross-sectional dimension that decreases from the proximal to distal direction by less than 6%. In one or more specific embodiments, the outer surface 338 of the tip 332 may have a taper that decreases from the proximal to distal direction of about 3% to about 5.9%, or about 0.5% to about 2.9%. In a specific embodiment, the outer surface 338 of the tip 332 has a taper that decreases from the proximal to distal direction of 5%.

[0056] In one or more embodiments, the outer surface 338 of the tip 332 may have a taper that decreases from the proximal to the distal direction by more than 6%, i.e., an outer cross-sectional dimension that decreases from the proximal to the distal direction at a rate of more than 6%.

[0057] In one or more embodiments, the length of the tip 332 from the distal wall 318 to the distal end 333 of the tip can be within a range of about 0.200 inches (5.080 mm) to about 0.500 inches (12.70 mm). In one or more specific embodiments, the length of the tip 332 can be within a range of about 0.250 inches (6.350 mm) to about 0.450 inches (11.43 mm), or more specifically, within a range of about 0.295 inches (7.500 mm) to about 0.400 inches (10.16 mm). In still further specific embodiments, the length of the tip 332 can be about 0.300 inches (7.620 mm).

[0058] When used with a corresponding non-luer connector, for example the female non-luer connector 200 of Figures 5-13, the tip 332 is inserted into the cavity 216 of the female non-luer connector 200. A force is applied distally to the syringe barrel 310 and / or proximally to the female non-luer connector 200 to engage the outer surface 338 of the tip 332 with the inner surface 214 of the wall 212 of the female non-luer connector in an interference fit connection and / or fluid tight engagement. To remove the female non-luer connector 200 from the syringe barrel 310, a force is applied proximally to the container and / or distally to the female non-luer connector 200 to disengage the interference fit connection and / or fluid tight engagement therebetween.

[0059] Figures 23-28 show another embodiment of a non-luer connector 400 for use in a drug delivery device according to the first aspect of the present invention. In particular, Figures 23-28 show a non-luer connector 400 including a non-luer portion 430 for attachment to a non-luer connector, for example the female non-luer connector 200 described above. As described above with reference to Figures 14-22, the non-luer connector 400 is shown integrally formed to a container in the form of a syringe barrel 410. As described above with reference to Figures 14-22, the container may be provided in other forms, for example in a medicine bag, an epidural pump, and other containers known in the art. The syringe barrel 410 shown in Figures 23-28 includes a distal wall 418. The non-luer portion 430 is integrally formed or provided in the container. 23-28, the non-luer portion 430 is provided in the form of a tip 432 that extends distally from a distal wall 418 of the syringe barrel 410 and includes an opening 434. The tip 432 includes a body wall 436 that extends from the distal wall 418 to a distal end 433 of the tip. The body wall 436 includes an outer surface 438 and an inner surface 440 that defines a passageway 442 that allows fluid communication between the chamber of the syringe barrel 410 and the opening 434. The distal end 433 of the tip 432 also includes an end wall 444 that extends inwardly from the outer surface 438 of the body wall 436 to the opening 434.

[0060] In the illustrated embodiment, the body wall 436 has a size and / or shape that prevents connection of a standard female luer connector, such as the needle hub 130 and syringe barrel 410 shown in FIG. 4. Specifically, the body wall 436 of the non-luer portion 430 has an outer cross-sectional dimension and / or thickness that does not fit into a typical luer connector having a smaller or larger inner cross-sectional dimension. In the illustrated embodiment, the body wall 436 is shown in the form of a continuous wall having a circular cross-section that forms an enclosure around the passageway 442 of the tip 432, which has a square cross-section. In one or more embodiments, the outer cross-sectional dimension of the body wall 436 at the outer surface 438 is greater than the inner cross-sectional dimension of the inner surface 134 of the hub body 132 of the needle hub luer connector 133. Thus, the hub body 132 cannot fit or slide over the body wall 436 such that the tip 432 is disposed within the cavity 136, and the inner surface 134 of the hub body 132 cannot form an interference fit connection and / or fluid tight engagement with the outer surface 438 of the body wall 436. The non-luer portion 430 therefore prevents connection of a standard female luer connector, e.g., needle hub 130. As described below, the non-luer portion 430 has an outer cross-sectional dimension that allows connection to another corresponding non-luer connector.

[0061] The thickness of the body wall 436 may also have a dimension that prevents connection of a standard female luer connector with the non-luer connector 430. Specifically, the body wall 436 may have a thickness that increases the outer cross-sectional dimension of the tip 432, which prevents the formation of an interference fit connection and / or fluid tight engagement with a standard female luer connector, as described above. The thickness of the body wall 436 may also be varied by decreasing the cross-sectional dimension of the passageway 442 while maintaining the outer cross-sectional dimension of the tip 432.

[0062] In one or more alternative embodiments, the tip 432 can have an outer cross-sectional dimension that is smaller than an inner cross-sectional dimension of a standard female luer connector, e.g., the luer connector 133 of the needle hub 130 shown in FIG. 4. In such embodiments, the smaller outer cross-sectional dimension of the body wall 436 prevents sufficient contact between the inner surface 134 of the luer connector and the outer surface 438 of the body wall to form an interference fit connection and / or fluid tight engagement therebetween. The non-luer portion 430 or tip 432 can also have a length that prevents the formation of an interference fit connection and / or fluid tight engagement with a standard female luer connector, e.g., the luer connector 133 of FIG. 4. In particular, the length of the body wall 436 can be too long or too short to allow the respective tapers of the body wall 436 and the inner surface 134 of the luer connector to align to form an interference fit connection and / or fluid tight engagement therebetween.

[0063] In one or more embodiments, the tip 432 has an outer cross-sectional dimension at the tip's distal end 433 or end wall 444 that is less than 0.1545 inches (3.925 mm). It will be understood that the outer cross-sectional dimension of the tip 432 includes the longest distance between two points on the tip's outer surface 438. In more specific embodiments, the tip 432 has an outer cross-sectional dimension at the tip's distal end 433 or end wall 444 that is within the range of about 0.1200 inches (3.048 mm) to about 0.1500 inches (3.810 mm), or more specifically, within the range of about 0.1300 inches (3.302 mm) to about 0.1400 inches (3.556 mm). In still further specific embodiments, the tip 432 can have an outer cross-sectional dimension at the end wall 444, or at the distal end of the tip, within the range of about 0.1306 inches (3.317 mm) to about 0.1326 inches (3.368 mm). In one or more specific embodiments, the outer cross-sectional dimension of the tip 432 at the end wall 444 or at the distal end 433 of the tip is within the range of about 0.100 inches (2.540 mm) to about 0.119 inches (3.023 mm), about 0.120 inches (3.048 mm) to about 0.129 inches (3.277 mm), about 0.130 inches (3.302 mm) to about 0.139 inches (3.531 mm), about 0.140 inches (3.556 mm) to about 0.149 inches (3.785 mm), or about 0.150 inches (3.810 mm) to about 0.154 inches (3.912 mm). The upper limits of the outer cross-sectional dimension of the tip 432 at the end wall 444 or distal end 433 of the tip can include 0.1328 inches (3.373 mm), 0.1326 inches (3.368 mm), 0.1330 inches (3.378 mm), 0.1332 inches (3.383 mm), 0.1334 inches (3.388 mm), 0.1336 inches (3.393 mm), and 0.1338 inches (3.399 mm).The lower limits of the outer cross-sectional dimension of the tip 432 at the end wall 444 or at the distal end 433 of the tip can include 0.1306 inches (3.317 mm), 0.1304 inches (3.312 mm), 0.1302 inches (3.307 mm), 0.1298 inches (3.297 mm), 0.1296 inches (3.292 mm), 0.1294 inches (3.287 mm), 0.1292 inches (3.282 mm), and 0.1290 inches (3.277 mm).

[0064] In one or more embodiments, the outer surface 438 of the tip 432 may have a taper that decreases from the proximal to distal direction of less than 6%, i.e., an outer cross-sectional dimension that decreases from the proximal to distal direction by less than 6%. In one or more specific embodiments, the outer surface 438 of the tip 432 may have a taper that decreases from the proximal to distal direction of about 3% to about 5.9%, or about 0.5% to about 2.9%. In certain embodiments, the outer surface 438 of the tip 432 may have a taper that decreases from the proximal to distal direction of 5%.

[0065] In one or more embodiments, the length of the tip 432 from the distal wall 418 to the distal end 433 of the tip, i.e., at the end wall 444, can be within a range of about 0.200 inches (5.080 mm) to about 0.500 inches (12.70 mm). In one or more specific embodiments, the length of the tip 432 from the distal wall 418 to the distal end 433 of the tip, i.e., at the end wall 444, can be within a range of about 0.250 inches (6.350 mm) to about 0.450 inches (11.43 mm), or more specifically, within a range of about 0.295 inches (7.500 mm) to about 0.400 inches (10.16 mm). In still further specific embodiments, the length of the tip 432 from the distal wall 418 to the distal end 433 of the tip, i.e., at the end wall 444, can be about 0.300 inches (7.620 mm).

[0066] When used with a corresponding non-luer connector, for example the female non-luer connector 200 of Figures 5-13, the tip 432 is inserted into the cavity 216 of the female non-luer connector 200. A force is applied distally to the syringe barrel 410 and / or proximally to the female non-luer connector 200 to engage the outer surface 438 of the tip 432 with the inner surface 214 of the wall 212 of the female non-luer connector in an interference fit connection and / or fluid tight engagement. To remove the female non-luer connector 200 from the syringe barrel 410, a force is applied proximally to the container and / or distally to the female non-luer connector 200 to disengage the interference fit connection and / or fluid tight engagement therebetween.

[0067] 29-34 show one or more embodiments of a non-luer connector 500 for use in a drug delivery device according to the second aspect of the present invention. FIGS. 29-34 show a non-luer connector 500 including a non-luer element 550 that prevents attachment of a standard female luer connector, such as the needle hub 130 described above, to the non-luer element 550. The non-luer connector 500 of FIGS. 29-34 is shown integrally formed to a container in the form of a syringe barrel 510, as described above with reference to FIGS. 14-22. The container may be provided in other forms, such as a medicine bag, an epidural pump, and other containers known in the art. The syringe barrel 510 shown in FIGS. 29-34 includes a distal wall 518. A tip 532 extends distally from the distal wall 518 of the syringe barrel 510 and includes a passageway 542 and an opening 534 in fluid communication with the chamber of the syringe barrel.

[0068] The outer surface 538 of the tip can have a size and / or shape that forms an interference fit connection and / or fluid tight engagement with an inner surface of a corresponding non-luer connector. In one or more embodiments, the outer surface 538 of the tip has a size and / or shape that can allow a user to force an incorrect interference fit connection and / or an incorrect fluid tight engagement of the non-luer connector 500 with a standard female luer connector. As described below, the non-luer element prevents such incorrect connection or engagement. In one or more embodiments, the outer surface 538 of the tip has a size and / or shape that prevents the formation of an interference fit connection and / or fluid tight engagement with a standard female luer connector and instead allows such a connection and / or engagement with a corresponding non-luer connector.

[0069] In one or more embodiments, the tip 532 has an outer cross-sectional dimension measured at the tip's distal end 536 that is less than 0.1545 inches (3.925 mm). In more specific embodiments, the tip has an outer cross-sectional dimension measured at the tip's distal end 536 that is within the range of about 0.1200 inches (3.048 mm) to about 0.1500 inches (3.810 mm), or more specifically, within the range of about 0.1300 inches (3.302 mm) to about 0.1400 inches (3.556 mm). In even more specific embodiments, the tip can have an outer cross-sectional dimension measured at the distal end 536 that is within the range of about 0.1306 inches (3.317 mm) to about 0.1326 inches (3.368 mm). In one or more specific embodiments, the outer cross-sectional dimension of the tip 532 measured at the distal end 536 is within the range of about 0.100 inches (2.540 mm) to about 0.119 inches (3.023 mm), about 0.120 inches (3.048 mm) to about 0.129 inches (3.277 mm), about 0.130 inches (3.302 mm) to about 0.139 inches (3.531 mm), about 0.140 inches (3.556 mm) to about 0.149 inches (3.785 mm), or about 0.150 inches (3.810 mm) to about 0.154 inches (3.912 mm). The upper limits of the outer cross-sectional dimension of tip 532 measured at distal end 536 can include 0.1328 inches (3.373 mm), 0.1330 inches (3.378 mm), 0.1332 inches (3.383 mm), 0.1334 inches (3.388 mm), 0.1336 inches (3.393 mm), 0.1314 inches (3.338 mm), and 0.1338 inches (3.399 mm). The lower limits of the outer cross-sectional dimension of the tip 532 measured at the distal end 536 can include 0.1304 inches (3.312 mm), 0.1307 inches (3.320 mm), 0.1302 inches (3.307 mm), 0.1298 inches (3.297 mm), 0.1296 inches (3.292 mm), 0.1294 inches (3.287 mm), 0.1292 inches (3.282 mm), and 0.1290 inches (3.277 mm).

[0070] In one or more embodiments, the outer surface 538 of the tip 532 may have a taper that decreases from the proximal to the distal direction of less than 6%, i.e., an outer cross-sectional dimension that decreases from the proximal to the distal direction by less than 6%. In one or more specific embodiments, the outer surface 538 of the tip 532 may have a taper that decreases from the proximal to the distal direction of about 3% to about 5.9%, or about 0.5% to about 2.9%. In a specific embodiment, the outer surface 538 of the tip 532 has a taper that decreases from the proximal to the distal direction of 5%.

[0071] In one or more embodiments, the length of the tip 532 from the distal wall 518 to the distal end 536 of the tip can be within a range of about 0.200 inches (5.080 mm) to about 0.500 inches (12.70 mm). In one or more specific embodiments, the length of the tip 532 from the distal wall 518 to the distal end 536 of the tip can be within a range of about 0.250 inches (6.350 mm) to about 0.450 inches (11.43 mm), or more specifically, within a range of about 0.295 inches (7.500 mm) to about 0.400 inches (10.16 mm). In still further specific embodiments, the length of the tip 532 from the distal wall 518 to the distal end 536 of the tip can be about 0.300 inches (7.620 mm).

[0072] The non-luer element 550 is integrally formed or disposed within the container. Specifically, in the embodiment shown in Figures 29-34, the non-luer element 550 is integrally formed and disposed within the distal wall 518 of the syringe barrel and extends distally in coaxial relationship with the tip 532. The non-luer element 550 forms a channel 560 between the tip 532 and the non-luer element 550. In the illustrated embodiment, the non-luer element 550 is shown as a plurality of barrier walls 552 extending distally from the distal wall 518. The barrier walls 552 include open or spaced apart distal ends 558 and proximal ends 559. The barrier walls 552 may be described as cantilevered relative to the distal wall 518.

[0073] The barrier wall 552 comprises an inner surface 554 facing the channel 560 and an outer surface 556. In the illustrated embodiment, the barrier wall 552 has a length equal to the length of the tip 532. In one or more alternative embodiments, the length of the barrier wall 552 can be less than the length of the larger tip 532 or greater than the length of the tip 532. When the length of the barrier wall 552 is less than the length of the tip 532, the length of the barrier wall 552 should not be so short that it cannot prevent a user from forcing an incorrect connection with a standard female luer connector. That is, the length of the barrier wall 552 is still sufficient to prevent such an incorrect connection. When the length of the barrier wall 552 is longer than the tip 532, the length of the barrier wall 552 is not particularly limited except by practical considerations related to ease of manufacture and ease of use. In one or more embodiments, the difference between the length of the barrier wall 552 and the length of the tip 532 is less than about 0.070 inches (1.778 mm). In one or more specific embodiments, the difference between the length of the barrier wall 552 and the length of the tip 532 is within the range of about 0.00 inch (0.000 mm) to about 0.050 inch (1.270 mm), or within the range of about 0.051 inch (1.295 mm) to about 0.070 inch (1.778 mm).

[0074] The inner surface 554 of the barrier wall 552 may have a plurality of threads disposed thereon for engaging corresponding structures of the non-luer connector. For example, when the female non-luer connector 200 is attached to the non-luer connector 500, the tab 220 disposed on the outer surface 203 of the female non-luer connector engages with a plurality of threads disposed on the inner surface 554 of the barrier wall 552. The engagement between the plurality of threads and the tab 220 is achieved by rotating the syringe barrel 510 and / or the non-luer connector 500 relative to the female non-luer connector 200.

[0075] The barrier wall 552 of the embodiment shown in FIGS. 29-34 comprises a cross-section having an outer cross-sectional dimension that is equal to or less than the inner cross-sectional dimension of a standard female luer connector, e.g., the inner cross-sectional dimension of the hub body 132 of FIG. 4. The outer cross-sectional dimension of the barrier wall 552 can be sized to prevent a luer connector, e.g., the open proximal end of the hub body 132, from entering the channel 560 and engaging the outer surface 538 of the tip 532. In one or more embodiments, the outer cross-sectional dimension of the barrier wall 552 can be less than the inner cross-sectional dimension of the standard luer connector and includes features that cause leakage between the standard luer connector and the barrier wall 552 when the standard luer connector is attached to the barrier wall 552. In one or more particular embodiments, the outer cross-sectional dimension of the barrier wall 552 can have a shape that prevents the standard female luer connector from entering the channel 560.

[0076] In one or more particular embodiments, the outer cross-sectional dimension of the barrier wall can be greater than 0.170 inches (4.315 mm). In one or more alternative embodiments, the thickness of the barrier wall 552 may be adjusted such that the inner cross-sectional dimension of the barrier wall 552 is less than 0.170 inches (4.315 mm) or is otherwise sized to prevent a standard female Luer connector from entering the channel 560.

[0077] In embodiments in which a standard female luer connector incorporates protrusions for engaging a corresponding male luer lock connector, the outer cross-sectional dimension of the barrier wall 552 may be greater than about 0.307 inches (7.80 mm). In embodiments in which the female luer connector does not incorporate protrusions, the outer cross-sectional dimension of the barrier wall 552 may be greater than about 0.224 inches (5.700 mm).

[0078] In one or more embodiments, the outer cross-sectional dimension of the barrier wall 552 is in the range of about 0.175 inches (4.445 mm) to about 0.500 inches (12.70 mm). In one or more specific embodiments, the outer cross-sectional dimension of the barrier wall 552 can be in the range of about 0.175 inches (4.445 mm) to about 0.264 inches (6.706 mm), about 0.265 inches (6.730 mm) to about 0.305 inches (7.747 mm), or about 0.305 inches (7.747 mm) to about 0.500 inches (12.70 mm). The upper limits of the outer cross-sectional dimension of the barrier wall 552 may include 0.300 inches (7.620 mm), 0.302 inches (7.671 mm), 0.304 inches (7.722 mm), 0.306 inches (7.772 mm), 0.308 inches (7.83 mm), 0.310 inches (7.874 mm), and 0.312 inches (7.925 mm). The lower limits of the outer cross-sectional dimension of the barrier wall may include 0.260 inches (6.604 mm), 0.262 inches (6.655 mm), 0.264 inches (6.706 mm), 0.266 inches (6.756 mm), 0.268 inches (6.807 mm), and 0.270 inches (6.858 mm).

[0079] In one or more embodiments, the barrier wall 552 has an inner cross-sectional dimension within a range of about 0.200 inches (5.080 mm) to about 0.305 inches (7.747 mm). In one or more specific embodiments, the barrier wall 552 has an inner cross-sectional dimension within a range of about 0.200 inches (5.080 mm) to about 0.264 inches (6.706 mm), or within a range of about 0.265 inches (6.730 mm) to about 0.305 inches (7.747 mm). Lower limits for the inner cross-sectional dimension of the barrier wall 552 include 0.260 inches (6.604 mm), 0.262 inches (6.655 mm), 0.264 inches (6.706 mm), 0.266 inches (6.756 mm), 0.268 inches (6.807 mm), and 0.270 inches (6.858 mm). Upper limits for the outer cross-sectional dimension of the barrier wall 552 include 0.300 inches (7.620 mm), 0.302 inches (7.671 mm), 0.304 inches (7.722 mm), 0.306 inches (7.772 mm), 0.308 inches (7.83 mm), and 0.310 inches (7.874 mm).

[0080] As shown in Figures 29B and 29E, in one or more embodiments, the non-luer element 550 can be provided as a continuous, single barrier wall that extends continuously around the tip 532. As shown in Figure 29B, in one or more embodiments, the non-luer element 550 may be provided as a uniform, continuous, single barrier wall that extends continuously around the tip 532. As shown in Figure 29E, in one or more embodiments, the non-luer element 550 may be provided as a continuous, single barrier wall that is flush with the tip 532 with one or more curvatures or indentations that extend around the tip 532, where the tip 532 is visible through the curvature or indentation of the collar. In the embodiments shown in Figures 29A, 29C, 29D, and 30-34, the non-luer element 550 is shown as a plurality of barrier walls 552 that form at least one gap 557 or multiple gaps spaced apart between the barrier walls 552. As shown in FIG. 29A, in one or more embodiments, the gap 557 of the illustrated embodiment extends from the distal end 558 to the proximal end 559 of the barrier wall. As shown in FIG. 29C and FIG. 29D, in one or more alternative embodiments, the gap 557 can extend from the distal end 558 to the distance between the distal end 558 and the proximal end 559. In embodiments incorporating the gap 557 in the barrier wall, if a standard female luer connector could fit onto the barrier wall 552 such that the inner surface of the luer connector contacts the outer surface 556 of the barrier wall, the gap 557 would prevent or impede the formation of a fluid-tight seal by providing an opening to the exterior of the connector through which fluid delivered through the tip would leak out. In one or more alternative embodiments, the gap 557 provides a visual indication of whether the non-luer element 550 functions as a slip connector or a locking connector. In other words, the gap 557 provides a visual indication as to whether the non-luer element 550 includes a luer slip fitting or a luer lock fitting.Specifically, the presence of gap 557 provides a visual indication that the inner surface 554 of barrier wall 552 does not include multiple threads or other locking features that cooperate to lock a corresponding non-luer connector to the barrier wall 552. In one or more embodiments, the absence of gap 557 provides a visual indication that the inner surface 554 of barrier wall 552 includes multiple threads or other locking features to lock a corresponding non-luer connector to the barrier wall 552.

[0081] In the illustrated embodiment, the barrier walls 552 are shown in the form of separate walls having a circular cross-section that, when taken together, form a partial enclosure around the tip 532, which also has a circular cross-section. In one or more embodiments, the barrier walls 552 can have a triangular cross-section, or other circular cross-section, that prevents a standard female luer connector having a circular cross-section, such as the hub body 132 of FIGS. 1-3, from fitting or slipping within the channel 560 and preventing the tip 532 and the inner surface 134 of the hub body 132 from forming an interference fit connection and / or fluid tight engagement with the outer surface 538 of the tip 532. Thus, the non-luer element 550 prevents connection of a standard female luer connector, such as the luer connector 133 of the needle hub 130, with the syringe barrel 510.

[0082] In one or more alternative embodiments, the barrier wall 552 can have an outer cross-sectional dimension that is smaller than an inner cross-sectional dimension of a standard female luer connector. In such embodiments, the smaller outer cross-sectional dimension of the barrier wall 552 prevents sufficient contact between the inner surface 134 of the standard female luer connector and the outer surface 556 of the barrier wall 552 to form an interference fit connection and / or fluid tight engagement therebetween. The barrier wall 552 can also have a length that prevents the formation of an interference fit connection and / or fluid tight engagement with a standard female luer connector, such as the luer connector 133 shown in FIG. 4. In particular, the length of the barrier wall 552 can be too long or too short to allow for fluid tight engagement with the inner surface 134 of the luer connector 133.

[0083] As described below, the non-luer element 550 may have an outer cross-sectional dimension that allows for connection to another corresponding non-luer connector. For example, the female non-luer connector 200 may have an exterior surface with an outer cross-sectional dimension such that the inner surface 214 is sized to fit within the channel 560 to form an interference fit connection and / or fluid tight engagement with the outer surface 538 of the tip.

[0084] As described above with reference to Figures 23-28, the non-luer element 550 may also be utilized to prevent a user from forcing an erroneous interference fit connection and / or fluid tight engagement between the tip 532 and a standard female luer connector when the female luer connector incorporates a valve or seal of a soft or semi-rigid material, typically rubber or elastomer. In such a device, the valve or seal may prevent a user from seeing an erroneous connection leak between the male connector and the female connector, since the rubber or elastomer valve or seal is adapted to the size and shape of the non-luer connector and seals against leakage of fluids within the female luer connector. Typically, such a valve or seal is disposed within a cavity in the hub of a standard female luer connector or on the inner surface of a cavity in the hub of a standard female luer connector. A standard female luer connector with such a valve or seal may be referred to as a soft luer connector or a semi-rigid luer connector. Typically, a valve or seal is utilized to allow the standard female luer connector inner surface or cavity to conform to various 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 the male connector. In such an embodiment, the outer surface 538 of the tip 532 can potentially be connected to a standard female luer connector, and the valve or seal provides a seal between the tip 532 and the standard female luer connector. In one or more embodiments, the barrier wall 552 is shaped and / or sized to have an inner cross-sectional dimension that prevents connection of the tip 532 with a standard female luer connector that includes a valve or seal as described above. Specifically, the inner cross-sectional dimension of the barrier wall 552 is greater than the inner cross-sectional dimension of the standard female luer connector and less than the outer cross-sectional dimension of the standard female luer connector. Thus, when attempting to connect a standard female luer connector to non-luer connector 500, the barrier wall 552 will physically block tip 532 from penetrating the rubber or elastomeric valve or seal, thereby causing the hub body of the standard female luer connector to align with barrier wall 552 such that it prevents the hub body of the standard female luer connector from adhering to tip 532.Thus, the non-luer connector 500 minimizes the risk that a user may utilize the non-luer connector 500 described herein with an unintended standard female soft luer connector.

[0085] In use, to assemble the non-luer connector 500 to the correct, corresponding non-luer connector, for example the female non-luer connector 200 shown in Figures 5-13, the wall 212 is inserted into the channel 560 between the barrier wall 552 and the tip 532 such that the tip 532 is disposed within the cavity 216. A force is applied distally to the syringe barrel 510 until the outer surface 538 of the tip engages the inner surface 214 of the wall of the female non-luer connector 200. In embodiments utilizing a threaded portion on the inner surface 554 of the barrier wall 552, the wall 212 of the female non-luer connector 200 is seated in the channel 560 and rotated relative to the syringe barrel 510 such that the tab 220 engages the threaded portion.

[0086] 35-41 show one or more embodiments of a non-luer connector 600 for use with a drug delivery device according to the second aspect of the present invention. FIGS. 35-41 show a non-luer connector 600 including a non-luer element 650 that prevents adhesion of a standard female luer connector, such as the needle hub 130 described above. The non-luer connector 600 of FIGS. 35-41 is shown integrally formed with a container in the form of a syringe barrel 610, as described above with reference to FIGS. 14-22. The container may be provided in other forms, such as a medicine bag, an epidural pump, or other containers known in the art. The syringe barrel 610 shown in FIGS. 35-41 includes a distal wall 618 and a tip 632 extending distally from the distal wall 618. The tip 632 includes a passageway 642 and an opening 634 in fluid communication with the chamber of the syringe barrel 610. The tip 632 includes a distal end 636 and a proximal end 639 .

[0087] The outer surface 638 of the tip can have a dimension and / or shape that forms an interference fit connection and / or fluid tight engagement with the outer surface of a corresponding non-luer connector, for example, a female non-luer connector 200. However, it should be understood that the dimension and / or shape of the outer surface 638 of the tip according to the present invention can allow a user to force an incorrect interference fit connection and / or fluid tight engagement of the non-luer connector 600 with a standard female luer connector. As described below, the non-luer element 650 prevents such incorrect connection or engagement. In one or more embodiments, the outer surface 638 of the tip has a dimension and / or shape that prevents the user from forcing an interference fit connection and / or fluid tight engagement with a standard female luer connector, but allows such connection and / or engagement with a corresponding non-luer connector. In one or more embodiments, the outer surface 638 of the tip has outer cross-sectional dimensions as described above with reference to Figures 29-34. In one or more embodiments, the outer surface 638 of the tip 632 can have a taper as also described above with reference to Figures 29-34. The outer surface 638 of the tip 632 in one or more embodiments can have a length as also described above with reference to Figures 29-34.

[0088] The non-luer element 650 is integrally formed or disposed within the container. Specifically, in the embodiment shown in Figures 35-41, the non-luer element 650 is integrally formed and disposed on the outer surface 638 of the tip 632. The non-luer element 650 extends radially outward from the outer surface 638 of the tip. The non-luer element 650 comprises an exterior surface 652 that defines an outer cross-sectional dimension, as measured from the outer surface 638 of the tip, that is greater than the outer cross-sectional dimension of the tip 632. In the illustrated embodiment, the non-luer element 650 is shown as a circular disk having at least one narrowing edge 654.

[0089] The non-luer element 650 is disposed between the distal end 636 and the proximal end 639 of the tip 632. In the illustrated embodiment, the non-luer element 650 is disposed approximately at a midpoint between the distal end 636 and the proximal end 639. In one or more alternative embodiments, the non-luer element 650 may be disposed adjacent to or at the distal end 636 of the tip 632. Optionally, the non-luer element 650 may be disposed adjacent to or at the proximal end 639 of the tip 632.

[0090] The location of the non-luer element 650 in one or more embodiments can be modified to prevent connection of a standard female luer connector with the tip 632. Specifically, in one or more embodiments, the non-luer element 650 can be disposed near the distal end 636 of the tip 632 to allow for fluid-tight engagement only with a corresponding female non-luer connector having an internal cavity of a length shorter than the cavity of the standard female luer connector. Thus, the non-luer element 650 prevents the standard female luer connector from sliding completely proximally over the tip 632 and prevents the formation of an interference fit connection and / or fluid-tight engagement between the standard female luer connector and the tip 632. That is, the standard female luer connector contacts the non-luer element 650 before the standard female luer connector is moved proximally enough over the tip 632 to form a fluid-tight connection through contact of the outer surface 638 of the tip with the inner surface of the standard female luer connector.

[0091] The non-luer element 650 of the embodiment shown in Figures 35-41 comprises a cross-section having an outer cross-sectional dimension that is greater than the inner cross-sectional dimension of a standard female luer connector, such as the luer connector 133 of the needle hub 130 shown in Figure 4. Specifically, the outer cross-sectional dimension of the non-luer element 650 prevents a standard female luer connector, such as the open proximal end of the hub body 132, from sliding or fitting over the tip outer surface 638 and fully engaging the tip outer surface 638. In other words, the non-luer element 650 acts as a barrier to movement of the luer connector on the tip 632 in the proximal direction.

[0092] In one or more embodiments, the outer cross-sectional dimension of the non-luer element 650 is within the range of about 0.175 inches (4.445 mm) to about 0.500 inches (12.70 mm). In one or more specific embodiments, the outer cross-sectional dimension of the non-luer element 650 is within the range of about 0.175 inches (4.445 mm) to about 0.305 inches (7.747 mm), or within the range of about 0.306 inches (7.772 mm) to about 0.500 inches (12.70 mm). Upper limits for the outer cross-sectional dimension of the non-luer element 650 include 0.300 inches (7.620 mm), 0.302 inches (7.671 mm), 0.304 inches (7.722 mm), 0.306 inches (7.772 mm), 0.308 inches (7.83 mm), and 0.310 inches (7.874 mm). Lower limits for the cross-sectional dimension of the non-luer element 650 include 0.170 inches (4.315 mm), 0.172 inches (4.369 mm), 0.174 inches (4.420 mm), 0.176 inches (4.470 mm), 0.178 inches (4.521 mm), and 0.180 inches (4.572 mm).

[0093] In the embodiment shown in Figures 35-41, the non-luer element 650 may be provided as a continuous, singular, disk-like structure that extends continuously circumferentially around the tip 632. In one or more embodiments, the non-luer element 650 may be provided in the form of individual protrusions disposed around a portion of the circumference of the outer surface 538 of the tip 532. Spaces may be provided between the protrusions. In embodiments incorporating individual protrusions and / or spaces between the protrusions, when a standard female luer connector can fit over the non-luer element 650 such that the inner surface of the luer connector contacts the outer surface 652 of the non-luer element 650, the spaces prevent or impede the formation of a fluid-tight seal by providing an area of ​​the non-luer element 650 and / or the outer surface 638 of the tip that does not contact the inner surface of the luer connector. In one or more specific embodiments, the spaces result in an opening from the interior of the standard female luer connector to the outer surface 638 of the non-luer connector that causes leakage of fluid.

[0094] In the illustrated embodiment, the non-luer element 650 has a circular cross-section. In one or more embodiments, the non-luer element 650 can have a square, triangular, or other non-circular cross-section that prevents a standard female luer connector having a circular cross-section, such as the luer connector 133 of the needle hub 130 of FIG. 4. Specifically, the hub body 132 of the needle hub 130 is prevented from fitting or sliding over the non-luer element 650 such that the tip 632 and the inner surface 134 of the hub body 132 cannot form an interference fit connection and / or fluid tight engagement with the outer surface 638 of the tip 632. Thus, the non-luer element 650 prevents connection of the syringe barrel 610 of the non-luer connector 600 with a standard female luer connector. Specifically, if the non-luer element 650 has a non-circular outer cross-sectional dimension that is smaller than the inner cross-sectional dimension of a standard circular female luer, there will be a gap at the contact point between the non-luer element 650 and / or tip 632 that will cause fluid leakage.

[0095] As described below, the non-luer element 650 is disposed at the tip 632 to enable connection of the tip 632 with another corresponding non-luer connector. For example, the cavity 216 of the female non-luer connector 200 may have a length equal to the length of the tip 632 from its distal end 636 to the non-luer element 650 such that the inner surface 214 forms an interference fit connection and / or fluid tight engagement with the outer surface 638 of the tip 632. Thus, in one or more embodiments, to enable the formation of an interference fit connection and / or fluid tight engagement between the tip 632 and the female non-luer connector 200, the non-luer element 650 is disposed such that the length of the tip 632 between a point distally adjacent the non-luer element 650 and the distal end 636 of the tip is equal to or less than the length of the cavity 216 of the female non-luer connector 200.

[0096] In one or more embodiments, the non-luer element 650 is positioned, shaped, and / or sized to have an outer cross-sectional dimension that prevents connection of the tip 632 with a standard female luer connector that includes a valve or seal, as described above with reference to Figures 29-34. In one or more embodiments, the non-luer element 650 is positioned to prevent the standard female luer connector from sliding up the length of the tip 632 such that upon piercing the valve or seal by the tip 632, the opening 634 of the tip 632 remains adjacent or near the open proximal end of the standard female luer connector, but does not enter the cavity sufficiently to cause substantial contact between the exterior surface of the tip 632 and the interior surface of the standard female luer connector. That is, the valve or seal of the standard female luer connector contacts the non-luer element 650 and prevents the standard female luer connector from moving further proximally before substantial contact between the tip 632 and the standard female luer connector is achieved. The placement of the opening 634 compromises the ability of a valve or seal to be disposed within the cavity of a standard female luer connector, resulting in a visible leak despite the presence of the valve or seal. Thus, the non-luer connector 600 minimizes the risk that a user may inadvertently utilize the non-luer connector 600 described herein with an unintended standard female luer connector.

[0097] In use, to assemble the non-luer connector 600 to a corresponding non-luer connector, for example the female non-luer connector 200 shown in Figures 5-13, the tip 632 of the non-luer connector 600 is disposed within the hub cavity 216. A force is applied distally to the non-luer connector 600 until the outer surface 638 of the tip 632 engages the inner surface 214 of the wall of the female non-luer connector 200 in an interference fit connection and / or fluid tight engagement.

[0098] 42-63 show one or more embodiments of a non-luer connector 700 for use in a drug delivery device according to the third aspect of the present invention. FIGS. 42-63 show a non-luer connector 700 including structure for preventing the formation of a liquid-tight connection between the non-luer connector 700 and a standard female luer connector by increasing the likelihood of liquid leakage or spillage in a misconnection. The non-luer connector 700 also has structure that allows attachment of the non-luer connector 700 to another corresponding non-luer connector, for example the female non-luer connector 200. The non-luer connector 700 of FIGS. 42-63 is shown integrally formed to a container provided in the form of a syringe barrel 710, as described above with reference to FIGS. 14-22. The container may be provided in other forms, for example in a medicine bag, an epidural pump, and other containers known in the art. The syringe barrel 710 shown in FIGS. 42-63 includes a distal wall 718. Tip 732 extends distally from distal wall 718 and includes a passageway 742 and an opening 734 that is in fluid communication with the chamber of syringe barrel 710. Tip 732 has a distal end 736 and a proximal end 739. The tip includes an end wall 740 disposed at distal end 736 that extends from opening 734 to an exterior surface 738 of the tip.

[0099] The outer surface 738 of the tip can have a size and / or shape that prevents the formation of a fluid-tight engagement with the inner surface of a standard female luer connector. In the illustrated embodiment, the tip 732 includes a non-luer element integrally formed therein. Specifically, the end wall 740 includes a notch 743, or other structure for enlarging the tip opening 734, such that the notch 743, or other structure for enlarging the tip opening 734, extends to the outer surface 738 of the tip. In other words, the notch 743 provides a path for fluid to escape from the opening 734 to the outer surface 738 of the tip even when the end wall 740 is pressed against a flat surface, such as the end wall of a standard female luer cavity, if the inner surface 214 of the cavity 216 does not form a tight interference fit with the outer surface 738 of the non-luer tip 732. To accomplish this, the notch 743 extends from the passageway through the side wall to form a gap in the side wall at the distal end of the tip. The notch 743 may provide a beveled or curved edge at the distal end 736 of the tip 732 adjacent the outer surface 738 of the tip that forms a gap in the side wall at the distal end of the tip.

[0100] To establish a fluid-tight engagement between the tip 732 and the hub or connector, a fluid-tight seal is typically formed between the outer surface 738 of the tip and the inner surface of the female connector, regardless of whether the hub or connector has a standard female luer connector or a female non-luer connector. If a fluid-tight seal is not formed between the inner surface (i.e., cavity) of the female connector and the tip 732, then a fluid-tight engagement will not be formed between the female connector and the tip 732. If a fluid-tight engagement is not formed, leakage may or may not occur for the following reasons.

[0101] In embodiments in which the outer surface 738 of the tip 732 has an outer cross-sectional dimension that prevents the formation of a fluid-tight seal with the inner surface of the cavity of the female connector, the distal end 736 of the tip 732 may have a dimension that allows the end wall 740 of the tip 732 to contact the distal end of the inner surface of the cavity and potentially form at least a partial fluid-tight seal, thereby allowing a user to utilize the tip 732 with a standard female Luer connector. In such a situation, any leakage that may result from the seal between the end wall 740 of the tip 732 and the distal end of the cavity of the female connector, even if only partially, may be too small to be noticed by the practitioner.

[0102] In the embodiment shown in Figures 42-63, the notch 743 disposed in the end wall 740 prevents the formation of a fluid-tight seal between the end wall 740 and the distal inner surface of a standard female luer hub, e.g., inner surface 134 of needle hub 130, because it provides a larger outlet or avenue for leakage of fluid within the container. Thus, the notch 743 prevents the formation of a fluid-tight seal at the end wall 740 of the tip 732 by providing an outlet to a side space between the tip 732 and the hub, even when the end wall 740 of the tip is in fluid-tight contact with the distal inner surface of the hub cavity. Thus, the notch 743 maximizes leakage between the tip 732 and the standard female luer connector if the connection between the tip 732 and the standard female luer connector is improper because a fluid-tight seal is not formed at the end wall 740 and fluid is allowed to leak between the inner surface 134 of the hub and the outer surface 738 of the tip.

[0103] For the hub or connector to properly establish a fluid tight engagement at the end wall 740, the female non-luer connector must have a size and / or shape to accommodate and seal the notch 743. The inner surface 214 of the female non-luer connector 200 may be molded to have a taper that corresponds to the taper of the non-luer male tip, thus providing intimate contact between the outer surface of the tip and the inner surface of the female connector, substantially eliminating any space between them that could allow fluid to leak out of the female connector. This completely seals or seals the notch 743, preventing fluid leakage from a proper non-luer male-female connection.

[0104] The notch 743 has a dimension and / or shape that prevents the inner surface of a standard female luer connector from sealing or sealing the notch 743. In one or more embodiments, the tip 732 can have a dimension, taper, or shape that allows the notch 743 to be positioned or arranged in a manner that prevents the inner surface of a standard female luer connector from sealing or sealing the notch 743. Specifically, in embodiments where the outer surface 738 of the tip has a taper, length, and / or outer cross-sectional dimension that prevents the formation of a fluid-tight seal with a standard female luer connector, the notch 743 may be positioned and may have a dimension or shape that prevents the inner surface of the standard female luer connector from contacting or adequately sealing or sealing the notch 743. In one or more embodiments, the length of the tip 732 may be modified such that attachment of a standard female luer connector to the tip 732 results in a dead space within the standard female luer connector and the tip 732 that prevents the formation of a seal between the standard female luer connector and the notch 743. Generally, the cut will have a depth measured from the end wall 740 toward the proximal end 739 of the tip 732 that is sufficient to allow an incorrect male-female connection to be visible leaking into the dead space, but not large enough to allow a correct connection to leak out despite sufficient contact between the outer surface of the tip and the inner surface of the female cavity.

[0105] In one or more embodiments, the notch 743 has a depth within the range of about 0.010 inches (0.254 mm) to about 0.100 inches (2.540 mm) measured from the end wall 740 toward the proximal end 739 of the tip 732. In one or more specific embodiments, the depth of the notch 743 can be within the range of about 0.01 inches (0.254 mm) to about 0.049 inches (1.245 mm), or within the range of about 0.500 inches (12.70 mm) to about 0.100 inches (2.540 mm). The upper limits for the depth of the cut 743 include 0.040 inches (1.016 mm), 0.042 inches (1.067 mm), 0.044 inches (1.118 mm), 0.046 inches (1.168 mm), 0.048 inches (1.219 mm), 0.050 inches (1.270 mm), 0.052 inches (1.321 mm), 0.054 inches (1.372 mm), 0.056 inches (1.422 mm), 0.058 inches (1.473 mm), and 0.060 inches (1.524 mm). Lower limits for the depth of the incision 743 include 0.005 inches (0.127 mm), 0.006 inches (0.1524 mm), 0.007 inches (0.1778 mm), 0.008 inches (0.2032 mm), 0.009 inches (0.2286 mm), 0.012 inches (0.3048 mm), 0.014 inches (0.3556 mm), 0.016 inches (0.4064 mm), 0.018 inches (0.4572 mm), and 0.02 inches (0.5080 mm). The incision 743 of one or more embodiments may have a width or cross-sectional dimension within a range of about 0.010 inches (0.254 mm) to about 0.080 inches (2.032 mm). In one or more specific embodiments, the notch 743 has a width within the range of about 0.01 inches (0.254 mm) to about 0.049 inches (1.245 mm), or within the range of about 0.05 inches (1.270 mm) to about 0.08 inches (2.032 mm).Upper limits for the width of the notch 743 include 0.040 inches (1.016 mm), 0.042 inches (1.067 mm), 0.044 inches (1.118 mm), 0.046 inches (1.168 mm), 0.048 inches (1.219 mm), 0.050 inches (1.270 mm), 0.052 inches (1.321 mm), 0.054 inches (1.372 mm), 0.056 inches (1.422 mm), 0.058 inches (1.473 mm), and 0.060 inches (1.524 mm). The lower limits of the width of the notch 743 may include 0.005 inches (0.127 mm), 0.006 inches (0.1524 mm), 0.007 inches (0.1778 mm), 0.008 inches (0.2032 mm), 0.009 inches (0.2286 mm), 0.012 inches (0.3048 mm), 0.014 inches (0.3556 mm), 0.016 inches (0.4064 mm), 0.018 inches (0.4572 mm), and 0.02 inches (0.5080 mm).

[0106] 42-48 is shown as a recess in the wall that extends through the width of end wall 740. Notch 743 can be characterized as two notches disposed on either side of opening 734.

[0107] In the embodiment shown in Figures 49-56, the end wall 740 may include two notches 744, 746. In the illustrated embodiment, the two notches 744, 746 are disposed at right angles to one another as measured from the opening 734. In one or more alternative embodiments, additional notches may be added. The notches may be spaced at regular or irregular intervals from one another. The notches in Figures 49-56 may also be described as four separate notches radiating outwardly from the opening 734 that are disposed across the end wall 740. The four notches are shown to be disposed at 90 degree intervals as measured from the opening 734.

[0108] In the embodiment shown in FIGS. 57-63, the end wall 740 can include a plurality of notches 750 disposed adjacent to one another along the circumference of the distal end. The plurality of notches 750 surround the opening of the tip 732. The plurality of notches 750 have a wedge shape, with each of the plurality of notches 750 extending into the end wall 740 to form a point. In other words, the plurality of notches have a zigzag profile. In one or more embodiments, each of the plurality of notches 750 includes a first side 752 having a decreasing slope extending proximally into the end wall and a second side 754 having an increasing slope extending distally from the first side to the first side of the adjacent notch. An edge 755 connects the first side and the second side. The edge 755 is shown as angled and / or having a decreasing slope from the outer surface 738 to the opening 734. The notches 750 may have a height that increases from the opening 734 to the outer surface 738 of the tip, as measured from the end wall 740. In other words, the notches 750 may be angled toward the opening 734 of the tip.

[0109] In one or more embodiments, the angled multiple cuts 750 include cutting edges 756 adapted to pierce or cut a valve or seal available with a standard female luer connector, as described above with reference to Figures 29-34 and 35-41. Specifically, when a user attempts to assemble a standard female luer connector having a valve or seal to a non-luer connector 700, the cutting edges 756 of the multiple cuts cut and / or pierce the valve or seal, thereby preventing the valve or seal from minimizing leakage between an improperly connected non-luer connector 700 and a standard female luer connector. In addition, the cutting edges 756 of one or more embodiments may also damage the standard female luer connector, further impeding or preventing the connection of the standard female luer connector with the non-luer connector 700. Thus, the cutting edges 756 minimize the risk that a non-luer connector 700 described herein may be utilized with an unintended standard female luer connector.

[0110] In one or more embodiments, the notches 743 disposed in the end wall 740 can be used in conjunction with at least one gap 557 spaced between the barrier walls 552 or multiple barrier walls 552 forming multiple gaps to prevent formation of a fluid-tight seal between the end wall 740 and the distal inner surface of a standard female luer hub by providing an opening to the exterior of the connector through which fluid delivered through the tip will leak. The gap 557 in this embodiment extends from the distal end 558 to the proximal end 559 of the barrier wall. In one or more alternative embodiments, the gap 557 can extend from the distal end 558 to a distance between the distal end 558 and the proximal end 559.

[0111] In one or more embodiments, the outer surface 738 of the tip can have an outer cross-sectional dimension and / or taper as described above with reference to Figures 29-34. The tip 732 of one or more embodiments can also have a length as described above with reference to Figures 29-34.

[0112] When used with a corresponding non-luer connector, for example the female non-luer connector 200 of Figures 5-13, the tip 732 is inserted into the cavity 216 of the female non-luer connector 200. A force is applied distally to the syringe barrel 710 and / or proximally to the female non-luer connector 200 to engage the inner surface 214 of the wall 212 of the female non-luer connector with the outer surface 738 of the tip 723 in an interference fit connection and / or fluid tight engagement. To remove the female non-luer connector 200 from the syringe barrel 710, a force is applied proximally to the container and / or distally to the female non-luer connector 200 to disengage the interference fit connection and / or fluid tight engagement therebetween.

[0113] In one or more embodiments, the notches 743, 744, 746 and the plurality of notches 750 may be utilized with male connectors that will adopt the proposed new standard for neuraxial applications. Specifically, under ISO 80369-6, for small bore connectors for liquids and gases in healthcare applications, the taper of the male and female connectors will be modified from 6% to 5% from the proximal to distal end of the existing ISO Luer standard male and female connectors. For male connectors, the new 5% taper provides a more gradual decrease in the connector's outer cross-sectional dimension from the proximal end to the open distal end. For female connectors, the new 5% taper provides a more gradual decrease in the connector's inner cross-sectional dimension from the open proximal end to the distal end, as shown in FIG. 64. In addition, the outer cross-sectional dimension at the open distal end of the male connector is less than the current ISO Luer standard range of 0.1545 inches (3.925 mm) to 0.1585 inches (4.027 mm). Specifically, the currently proposed ISO standard provides for the outer cross-sectional dimension of the male connector at the open distal end to measure within the range of about .1306 inches (3.317 mm) to about .1326 inches (3.369 mm). The side cross-sectional dimension of the female connector at the open proximal end is less than the current ISO Luer standard range of 0.168 inches (4.270 mm) to 0.170 inches (4.315 mm). Specifically, the currently proposed ISO standard provides for the inner cross-sectional dimension of the female connector at the open proximal end to measure within the range of about 0.1417 inches (3.599 mm) to about 0.1437 inches (3.650 mm). The length of the male connector for neuraxial applications also increases from 0.295 inches (7.500 mm) to approximately 0.300 inches (7.620 mm). The length of the female connector for neuraxial applications also increases from 0.295 inches (7.500 mm) to approximately 0.303 inches (7.696 mm).

[0114] The more gradual taper in the new ISO standard for neuraxial applications for both the male and female connectors, as well as the smaller outer and inner cross-sectional dimensions of the male and female connectors, are intended to prevent a liquid-tight connection between the male connector for neuraxial applications and the female standard Luer connector, respectively. However, the smaller outer cross-sectional dimension of the male connector for neuraxial applications at its distal end may allow a user to inadvertently or intentionally attach the male connector for neuraxial applications to a female standard Luer connector, which may have inner cross-sectional dimensions at its distal end that can 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 may allow the formation of at least a partial liquid-tight engagement, even if not ideal, sufficient to deliver unintended fluids or liquids to a patient at an erroneous delivery site.

[0115] Notches 743, notches 744, 746, and notches 750 described herein connect opening 734 to outer surface 738 of the tip and prevent a 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 cannot establish sufficient fluid-tight engagement to utilize a male connector for neuraxial applications that is mistakenly attached to a female standard Luer connector. Specifically, notches 743, notches 744, 746, and notches 750 increase leakage from such an incorrect connection and prevent circumvention of the new ISO proposal for neuraxial applications.

[0116] One or more embodiments of the present invention may incorporate visual indicia to provide a visual indication regarding the compatibility of the components of the drug delivery device described herein. Specifically, the container with the non-luer connector may have a color corresponding to the color of the correct corresponding female non-luer connector, or may be made from a colored polymeric material corresponding to the color of the correct corresponding female non-luer connector. In one or more embodiments, the plunger rod of the syringe may also have a color corresponding to the correct corresponding female non-luer connector. Visual indicia may be placed on the hub body and / or needle shield of the female non-luer connector. Other visual indicia may include markings to inform that the container and / or the female non-luer connector includes a non-luer connector.

[0117] Throughout this specification, references to "one embodiment," "some embodiments," "one or more embodiments," or "an embodiment" mean that a particular feature, structural material, or characteristic described in connection with an embodiment is included in at least one embodiment of the invention. Thus, the appearances of phrases such as "in one or more embodiments," "in some embodiments," "in one embodiment," or "in one embodiment" in various places throughout this specification do not necessarily refer to the same embodiment of the invention. Furthermore, particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0118] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It will be apparent to those skilled in the art that various modifications and variations can be made to the method and apparatus of the present invention without departing from the spirit and scope of the invention. Therefore, it is intended that the present invention cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. 1. A drug delivery device comprising: a container having an open distal end including a distal wall, a sidewall including an inner surface defining a fluid chamber for holding a fluid, and an elongated tip extending distally from said distal wall, said elongated tip including an opening providing access to said fluid chamber, an inner surface including a taper decreasing from a proximal direction to a distal direction of less than 6%, and an outer cross-sectional dimension sized to prevent connection of the container to a standard female Luer connector; a female non-luer connector removably attached to the elongate tip of the container, the hub body including an open proximal end, an interior surface defining a cavity having a cross-sectional width that decreases from a proximal to a distal direction by less than 6% and that is sized to prevent connection of the female non-luer connector to a corresponding standard luer connector, and a needle cannula attached to the hub body, the needle cannula including an open distal end that is in fluid communication with the opening of the container when the container and the female non-luer connector are connected; The drug delivery device characterized in that the container comprises a non-luer element disposed at an open distal end including the distal wall, the non-luer element including a plurality of barrier walls forming at least one gap spaced between the plurality of barrier walls to allow access to a channel, which is a space between the plurality of barrier walls and the elongated tip, the gap providing an exit for fluid to leak from an opening of the non-luer element when the plurality of barrier walls are mated with a standard female luer connector, a fluid-tight seal is formed between the female non-luer connector and the container, and an indication that the needle cannula is in fluid communication with the opening of the container.

2. A non-luer connector for connecting to a female non-luer connector, a container having an open distal end including a distal wall, a sidewall including an inner surface defining a fluid chamber for holding a fluid, and an elongated tip extending distally from the distal wall, the elongated tip including an opening providing access to the fluid chamber and an outer cross-sectional dimension sized to prevent connection of the container to a standard female luer connector; and a non-luer element disposed in the open distal end that creates leakage between the standard luer connector and the container when the standard luer connector is attached to the container; a non-luer element including a plurality of barrier walls spaced apart from one another to form at least one gap allowing access to a channel, which is a space between the plurality of barrier walls and the elongate tip, the non-luer element including a distal end and a proximal end, the at least one gap extending from the distal end of the non-luer element to the proximal end of the non-luer element, the gap providing an exit for fluid to leak from an opening of the non-luer element when the plurality of barrier walls are mated with a standard female luer connector, a fluid-tight seal being formed between the female non-luer connector and the container, and providing an indication that a needle cannula including an open distal end in fluid communication with the opening of the container when the container and the female non-luer connector are connected is in fluid communication with the opening of the container.

3. 3. The non-luer connector of claim 2, wherein the non-luer element extends distally from the distal wall of the container and is coaxially disposed around the elongate tip, the non-luer element forming a channel between the elongate tip and the non-luer element for receiving a portion of the female non-luer connector.

4. 4. The non-luer connector of claim 3, wherein the inner cross-sectional dimension of the non-luer element is larger than the inner cross-sectional dimension of a standard female luer connector and smaller than the outer cross-sectional dimension of the standard female luer connector.

5. 5. The non-luer connector of claim 4, wherein the non-luer element has one of a circular, square, and triangular cross-sectional shape.

6. 1. An assembly comprising:

6. An assembly comprising the non-luer connector of claim 5 and a female non-luer connector, the female non-luer connector being removably attached to the elongated tip of the container, the female non-luer connector comprising: a hub body including an open proximal end and an inner surface defining a cavity dimensioned for a fluid-tight seal against the elongated tip of the female non-luer connector; and a needle cannula attached to the hub body, the needle cannula including an open distal end in fluid communication with the cavity.

7. 3. The non-luer connector of claim 2, wherein the at least one gap includes at least two gaps and has a curved cross section between the two gaps.

8. 3. The non-luer connector of claim 2, wherein the at least one gap provides a visual indication as to whether the non-luer connector comprises a luer slip fitting or a luer lock fitting.

9. 3. The non-luer connector of claim 2, wherein the at least one non-luer connector has dimensions selected to prevent formation of a fluid-tight seal between the non-luer element and a standard female luer connector.

10. 4. The non-luer connector of claim 3, wherein the non-luer element includes a distal end extending distally past the elongate tip.

11. 4. The non-luer connector of claim 3, wherein the elongate tip includes a distal end that extends distally past the non-luer element.

12. 4. The non-luer connector of claim 3, wherein the barrier walls have a length less than or equal to the elongate tip.

13. 4. The non-luer connector of claim 3, wherein the plurality of barrier walls have a length greater than or equal to the elongate tip.

14. 3. The non-luer connector of claim 2, wherein the barrier walls have a plurality of threads disposed thereon for engaging corresponding structures on the non-luer connector.

15. 3. The non-luer connector of claim 2, wherein the outer cross-sectional dimensions of the barrier walls are smaller than the inner cross-sectional dimensions of a standard luer connector, the outer cross-sectional dimensions causing leakage between the standard luer connector and the barrier walls.

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