Patent Description:
In the medical field, fluids are frequently administered as infusions. The container holding the medical fluid, such as a flexible intravenous (IV) bag, is connected to an infusion device, such as an IV needle, by a disposable IV set comprising tubing having one or more fittings or connectors. IV sets may also have intermediate ports or connection points where additional fluid containers may be connected to introduce or withdraw fluid. The tubing is connected to the fittings or connectors by one or more forms of mechanical attachment, that is inserted into the interior of the tubing, and bonding, such as a solvent weld between an internal pocket of the fitting and the exterior surface of the tubing.

Medical connectors are widely used in fluid delivery systems such as those used in connection with intravenous (IV) fluid lines, blood access, hemodialysis, peritoneal dialysis, enteral feeding, drug vial access, etc. Medical connectors may generally connect two fluid lines or tubing.

<CIT> relates to a catheter connector configured to provide an escape location for a liquid medium trapped therein. The catheter connector includes a body having a proximal end and a distal end. The proximal end includes a proximal end port for mating communication with a fluid delivery device. The body defines a hollow interior extending from the proximal end to the distal end. In one embodiment, the catheter connector includes an insert configured within the hollow interior of the connector. The insert defines a bore therethrough that is configured to receive a catheter at least partially therein. Further, the bore includes an interior wall and an exterior wall defining a thickness therebetween. The interior wall includes at least one discontinuity. Thus, when the catheter is inserted through the bore, at least one cavity is formed by the catheter and the at least one discontinuity of the insert. The cavity is configured to collect a liquid medium within the catheter connector, thereby maintaining a secure connection between the catheter and the catheter connector. In another embodiment, the hollow interior of the catheter connector may be manufactured with at least one discontinuity so as to form a cavity configured to collect a liquid medium within the catheter connector.

<CIT> relates generally to fittings used in connecting tubings as used in medical devices, and more particularly concerns protecting such tubing connections against contamination.

<CIT> pertains to a luer-lock connector system for medical devices and, more particularly, to a protective cap for use with a luer-lock connector.

<CIT> relates to medical devices. More specifically, this invention relates to luer lock connectors for use in insufflation systems.

The medical connector may be a hollow tubular structure that receives a fluid line or tubing at one end thereof. The connector provides a flow path for fluid entering from the tubing to exit the connector from the opposite end thereof. The presence of fluid in the tubing may create a hermetic seal between outer surface of the tubing and the inner surface of the medical connector. The seal may prevent the tubing from separating from the medical connector. However, when the fluid is absent in the tubing or when the amount of fluid in the tubing is reduced, the seal may be weakened and the tubing may be separated easily from the connector, thereby creating a "free flow" leak.

Furthermore, where microbore tubing is used, the minimal surface area of the microbore tubing for bonding presents additional challenges to retaining the microbore tubing in the connector.

In accordance with various embodiments of the present disclosure, a connector includes a body having a tubing portion, a luer portion axially opposite the tubing portion and connected thereto, and an inner circumferential surface defining an internal bore of the connector. The inner circumferential surface extends axially between the tubing portion and the luer portion, and the internal bore is in fluid communication with the tubing portion and the luer portion. The inner circumferential surface includes a plurality of splines extending axially along a length of the inner circumferential surface in the tubing portion of the connector. The inner circumferential surface is configured to engage an external surface of a tubing in a coupled configuration. In the coupled configuration edges of the splines grip and engage the external surface of the tubing to retain the tubing in the body.

In accordance with various embodiments of the present disclosure, a connector includes a body having a tubing profile, a luer profile axially opposite the tubing portion and connected thereto, a restriction interposed between the luer profile and the tubing profile, and an inner circumferential surface defining an internal bore in at least the tubing profile. The restriction includes a first end along the luer profile, a second end along the tubing profile, and a projection extending axially from the second end, and the projection extends into the internal bore. The inner circumferential surface is configured to engage an external surface of a tubing in a coupled configuration. In the coupled configuration the projection grips the tubing to create a seal between the second end of the restriction and the tubing.

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

Various embodiments of the present disclosure are directed to providing a connector having greater tubing retention for IV sets that use microbore tubing which has minimal surface area for bonding.

Various embodiments of the present disclosure are additionally directed to providing connector having improved sealing capabilities so as to prevent fluid from inadvertently leaking between the external surface of the tubing (e.g., microbore tubing) and the internal surface of the connector.

Embodiments disclosed are directed to a connector having a retaining mechanism for preventing a microbore tubing coupled thereto from dislodging and/or separating from the connector in the absence (or reduction) of fluid in the tubing. Embodiments disclosed herein are further directed to a connector having a restriction mechanism to retain the tubing in the connector and seal between the tubing and the inner surface of the connector. As disclosed herein, the retaining mechanism may include a plurality of splines extending axially along an inner circumference of a tubing portion of the connector. As the fluid line (tubing) is inserted into the tubing portion, edges of the axial splines may dig into and grip the tubing for greater tubing retention within the tubing portion of the connector. For example, the fluid line may be inserted into the tubing portion with an interference fit whereby the outer diameter of the fluid line is slightly larger than the inner diameter of the tubing portion. As a result, a relatively stronger tensile force is required to be exerted on the tubing to separate or dislodge the tubing from the connector. Thus, accidental separation of the tubing may be minimized.

Further advantageously, adjacent neighboring splines define a corresponding recesses or channels therebetween similarly extending axially along an inner circumference of the tubing portion of the connector. As such, an increased amount of solvent for bonding the fluid line or tubing to the tubing portion may be collected into the channels for maximum boding. This will insure a uniform spread of solvent and eliminate possible squeegee of fluid on the bonding surface. This is in contrast to conventional connector and fluid line bonding techniques where the solvent is flowed into the connector and once the tubing is inserted into the connector, the solvent is subject to squeegee by the tubing, thereby reducing surface area of the solvent between the tubing and the connector for bonding.

As disclosed herein, the restraining mechanism may include radial projections, sealing rings, or alternatively barbed fittings, barbed edges, or similar structures that may retain the tubing. The restriction mechanism ensures that a seal is maintained between the tubing and the inner surface of the connector during low pressure conditions (e.g., during the absence of fluid in the tubing) since there is an interference fit between the tubing and the connector. As a result, a relatively stronger tensile force is required to be exerted on the tubing to separate or dislodge the tubing from the connector. Thus, accidental separation of the tubing is minimized.

In some embodiments, the restriction mechanism may include one or more radial projections or ledges on an internal surface of the connector that limits the extent of the tubing in the connector when inserted therein. As discussed below, the connector at the end opposite to the end receiving the tubing may include a female luer fitting. The restriction mechanism prevents the tubing from extending into the female luer fitting during assembly and thereby ensures correct operation of the medical connector.

Another advantage of the medical connector, according to embodiments disclosed, is that there is not a substantial increase in the manufacturing costs of the medical connector. Existing manufacturing equipment may be modified at minimal costs to manufacture the example medical connector. For example, the core pins of the injection molding equipment used to manufacture the medical connector may be redesigned to create the axial splines and channels, and the restraining mechanisms.

As used herein, the terms "tubing," "fluid line," and any variation thereof refers to medical lines or tubes used to deliver liquids, solvents, or fluids (including gas) to or from a patient under medical care. For example, fluid lines (tubing) may be used for intravenous (IV) delivery of fluids, fluid drainage, oxygen delivery, a combination thereof, and the like.

As used herein, the terms "medical connector," "connector," "fitting," and any variation thereof refer to any device used to provide a fluid flow path between two or more fluid lines coupled thereto. For example, the medical connector may be or include a bond pocket or other types of connectors.

<FIG> depicts a perspective view of an IV set <NUM> having a medical connector <NUM> that may employ the principles of the present disclosure, in accordance with some embodiments of the present disclosure. As depicted, the IV set may include a fluid source such as a fluid bag <NUM> which may include or contain saline solution or other fluid to be administered to a patient. As illustrated, a first tubing <NUM> carries flow from a drip chamber <NUM>, through connector <NUM>, and into a second fluid line or tubing <NUM>. An IV pump (not shown) receives fluid from fluid system <NUM> via second tubing <NUM>, and controls and dispenses the fluids therefrom to a patient. As shall be described in further detail below, a tubular portion of the connector <NUM> has an internal bore configured to receive the second tubing <NUM>. For the purposes of the present disclosure, the second tubing <NUM> will be described as microbore or smallbore tubing, and the connector <NUM> will thus be described as being configured to receive and retain microbore tubing. However, the various embodiments of the connector described herein may be applied to other types of tubing, e.g. macrobore or largebore tubing.

<FIG> illustrates a cross-sectional view of the medical connector <NUM> of <FIG>, according to embodiments disclosed. As illustrated, the medical connector <NUM> (or simply, connector) may include a generally cylindrical body <NUM> having a "first" or tubing portion <NUM> and a "second" or luer portion <NUM> axially opposite the tubing portion <NUM> and connected thereto. In some embodiments, the body <NUM> may also include a grip <NUM> disposed along the outer surface of the body <NUM>. The tubing portion <NUM> may include a tubing port <NUM> that is sized and shaped or otherwise configured to receive a fluid line (referred to hereafter as "tubing"), as discussed below. Similarly, the luer portion <NUM> may include a luer port <NUM> that is sized and shaped or otherwise configured to receive a male luer connector. As depicted, the body <NUM> defines an internal longitudinal passageway or bore <NUM> extending from the tubing port <NUM> to the luer port <NUM> and fluidly connecting the tubing port <NUM> and the luer port <NUM> with each other.

In the depicted embodiments, the internal bore <NUM> is defined by the inner circumferential surface <NUM> of the body <NUM> and is continuous from the tubing port <NUM> to the luer port <NUM>. In some embodiments, the inner circumferential surface <NUM> in the tubing portion <NUM> and the luer portion <NUM> has two non-similar profiles. Specifically, the inner circumferential surface <NUM> in the tubing portion <NUM> has a tubing profile <NUM> and the inner circumferential surface <NUM> in the luer portion <NUM> has a luer profile <NUM>. The tubing profile <NUM>, and thereby the tubing portion <NUM> of the connector <NUM>, is sized and shaped (or otherwise configured) to receive a tubing. In particular, the tubing profile <NUM> may be sized, shaped, and otherwise configured to receive a microbore tubing <NUM> (described in further detail below). For example, tubing having an inner diameter of less than <NUM> inches, and particularly tubing having an outer diameter of approximately <NUM> inches or less, is considered "smallbore" or "microbore" and is bonded into a tubing pocket such as the internal bore <NUM> defined in tubing profile <NUM>. Tubing having an inner diameter of greater than <NUM> inches is typically considered "macrobore. " Exemplary embodiments of the present disclosure are illustrated and described herein with respect to a tubing that is in the form of a "smallbore" or "microbore" tubing and a pocket bond for a "smallbore" or "microbore" tubing. However, the various embodiments of the present disclosure are not limited to the aforementioned configuration and may similarly be applied to "largebore" or "macrobore" tubing and related connectors, as well as any other intermediate size tubings and connectors between "microbore" and "macrobore" connectors. The luer profile <NUM>, and thereby the luer portion <NUM> of the connector <NUM>, may be sized and shaped (or otherwise configured) to receive male luer fittings. The luer profile <NUM>, and thereby the luer portion <NUM>, may be ISO-<NUM> compliant.

During assembly, in order to limit the extent of the tubing inserted, advanced, or otherwise "slipped" into the connector <NUM>, the inner circumferential surface <NUM> may include a restriction mechanism (hereafter referred to as "restriction <NUM>"). The restriction <NUM> may be defined to protrude radially inward from the inner circumferential surface <NUM>, and may be interposed between the luer profile <NUM> and the tubing profile <NUM>. In some embodiments, the restriction <NUM> serves as a stop for the insertion of tubing into the internal bore <NUM> defined in the luer profile <NUM>. Accordingly, restriction <NUM> may have a diameter D2 (illustrated in <FIG>) that is smaller than the smallest diameter D1 of the internal bore <NUM> defined in the tubing profile <NUM>.

In accordance with some embodiments, the tubing profile <NUM> of the tubing portion <NUM> may include a retaining mechanism for improving the ability of the connector <NUM> to retain the microbore tubing <NUM> inserted therein and thereby prevent the microbore tubing <NUM> from separating (or otherwise dislodging) from the connector <NUM>. For example, the retaining mechanism may prevent the microbore tubing <NUM> from separating (or otherwise dislodging) from the connector <NUM> during a low pressure condition in the tubing created due to a reduction in the fluid in the tubing. In an example, and as illustrated, the retaining mechanism may be or include a plurality of splines <NUM> axially extending axially along the inner circumferential surface <NUM> of the tubing portion <NUM> of connector <NUM>. As the microbore tubing <NUM> (illustrated in <FIG>) is inserted into the tubing portion <NUM> of the connector <NUM>, inner circumferential surface <NUM> in the tubing portion <NUM> is configured to engage an external surface of the microbore tubing <NUM> in a coupled configuration. For example, as the microbore tubing <NUM> is inserted into the tubing portion <NUM>, edges <NUM> of the axial splines <NUM> may dig into and grip the exterior surface of the tubing for greater tubing retention within the tubing portion of the connector. Thus, in the coupled configuration, the microbore tubing <NUM> may be inserted into the tubing portion with an interference fit such that edges <NUM> of the axial splines <NUM> dig into, grip and engage the external surface of the microbore tubing <NUM> to retain the microbore tubing <NUM> in the tubing portion <NUM> of the connector <NUM>. The aforementioned configuration provides the advantage that once the edges <NUM> of the axial splines <NUM> dig into, grip and engage the external surface of the microbore tubing <NUM>, friction between the microbore tubing <NUM> and inner circumferential surface <NUM> is increased such that the microbore tubing <NUM> may not be easily dislodged from the connector <NUM>, without departing from the scope of the disclosure. For example, by biting or digging into the external surface of the microbore tubing <NUM>, the axial splines may increase the friction between the connector <NUM> and the microbore tubing <NUM> when a tensile force (direction indicated by the arrow F, illustrated in <FIG>) is applied on the microbore tubing <NUM> to remove it from the connector <NUM>. Advantageously as a result, the tensile force required to remove or otherwise dislodge the microbore tubing <NUM> from the connector <NUM> is increased and thus the microbore tubing <NUM> is better secured and retained in the connector <NUM>. Further, fluid in the microbore tubing <NUM> may exert pressure in a radially outward direction, which may further increase the friction between the microbore tubing <NUM> and the inner circumferential surface <NUM>.

In accordance with some embodiments, adjacent neighboring splines <NUM> define corresponding recesses or channels <NUM> therebetween. The channels <NUM> similarly extend axially along the inner circumferential surface <NUM> of the tubing portion <NUM> of connector <NUM>. Advantageously, an increased amount of solvent for bonding the microbore tubing <NUM> to the inner circumferential surface <NUM> defined in the tubing portion <NUM> may be collected into the channels <NUM> for maximum bonding. In particular, collecting the solvent in the channels <NUM> allows for an increased amount of solvent available for bonding of the microbore tubing <NUM> to the inner circumferential surface <NUM> of the tubing portion <NUM>. Providing the channels <NUM> with the solvent collected therein will yield a uniform spread of solvent and eliminate possible squeegee of fluid on the bonding surface of the tubing portion <NUM>. Thus, a maximum amount of solvent remains available for bonding the microbore tubing <NUM> to the inner circumferential surface <NUM> of the tubing portion <NUM>, and an even greater tubing retention may be achieved. This is in contrast to conventional connector and tubing bonding techniques where the solvent is flowed into the connector and once the fluid line/tubing is inserted into the connector, the solvent is subject to squeegee by the tubing, thereby reducing surface area of the solvent between the tubing and the connector.

<FIG> is a partial cross-sectional view of axial splines and channels of the tubing section of the connector of <FIG>, in accordance with some embodiments of the present disclosure. <FIG> is an enlarged partial view of the axial splines and channels of the tubing section of the connector of <FIG>, in accordance with some embodiments of the present disclosure.

Referring to <FIG>, with continued reference to <FIG>, each of the axial splines may be defined by a first inclined surface <NUM>, a second inclined surface <NUM> and the edge <NUM> interposed between the first and second inclined surface <NUM> and <NUM>. As depicted, the axial splines may be formed in the shape of teeth of a spline gear. Since the channels <NUM> are defined between adjacent splines <NUM>, each of the channels <NUM> are defined by adjacent first and second inclined surfaces <NUM> and <NUM> meeting at a vertex <NUM>. However, the shapes of the axial splines <NUM> and channels <NUM> is not limited to the aforementioned configuration. For example, the axial splines <NUM> and channels <NUM> may not be restricted to any particular shape or size as long as the axial splines <NUM> have a shape so as to "bite into," "dig into," grip, or otherwise engage the outer surface of the microbore tubing <NUM>, and as long as the channels <NUM> form a recess of sufficient depth to contain a solvent therewithin.

In accordance with some embodiments, the axial splines <NUM> and channels <NUM> may be disposed at regular intervals along the inner circumferential surface <NUM> of the tubing portion <NUM>. However, in other embodiments, the axial splines <NUM> and channels <NUM> may be disposed at irregular intervals along the inner circumferential surface <NUM> of the tubing profile <NUM>.

In accordance with some embodiments, an angle α between the first inclined side <NUM> and the second inclined side <NUM> of adjacent splines ranges from about <NUM> degrees to <NUM> degrees, more typically about <NUM> degrees to <NUM> degrees, <NUM> degrees to <NUM> degrees, or in some cases approximately <NUM> degrees. Though recited in terms of certain ranges, it will be understood that all ranges from the lowest of the lower limits to the highest of the upper limits are included, including all intermediate ranges or specific angles, within this full range or any specifically recited range.

In some embodiments, a height of each of the splines as measured from the vertex <NUM> to the edge <NUM> of each spline may range from about <NUM> inches to <NUM> inches, more typically about <NUM> inches to <NUM> inches, <NUM> inches to <NUM> inches, or in some cases approximately <NUM> inches. Accordingly, a depth of each of the channels <NUM> defined by adjacent splines <NUM> may range from about <NUM> inches to <NUM> inches, more typically about <NUM> inches to <NUM> inches, <NUM> inches to <NUM> inches, or in some cases approximately <NUM> inches. Though recited in terms of certain ranges, it will be understood that all ranges from the lowest of the lower limits to the highest of the upper limits are included, including all intermediate ranges or specific dimensions, within this full range or any specifically recited range.

In some embodiments, the depth of each of the channels tapers in a direction towards the tubing port <NUM>. For example, each of the channels <NUM> may have a maximum depth in the region adjacent to the second end <NUM> of the restriction <NUM>. As the channels <NUM> approach the tubing port <NUM>, the depth of each of the channels <NUM> may progressively decrease until each channel <NUM> terminates.

Referring back to <FIG>, a length of each of the axial splines <NUM> spans a portion of the length of the inner circumferential surface <NUM> of the tubing portion <NUM>. In some embodiments, the length of the axial splines <NUM> spans between about <NUM>% and <NUM>% of the length of the inner circumferential surface <NUM> of the tubing portion <NUM>, more typically between about <NUM>% and <NUM>%, between about <NUM>% and <NUM>%, or in some cases approximately <NUM>% of the length of the inner circumferential surface <NUM> of the tubing portion <NUM>. Since the channels <NUM> are defined between adjacent axial splines <NUM>, the length of each of the channels <NUM> similarly may spans between about <NUM>% and <NUM>% of the length of the inner circumferential surface <NUM> of the tubing portion <NUM>, more typically between about <NUM>% and <NUM>%, between about <NUM>% and <NUM>%, or in some cases approximately <NUM>% of the length of the inner circumferential surface <NUM> of the tubing portion <NUM>. Though recited in terms of certain ranges, it will be understood that all ranges from the lowest of the lower limits to the highest of the upper limits are included, including all intermediate ranges or specific percentages, within this full range or any specifically recited ranges. It is advantageous to ensure that the channels do not extend all the way through the tubing port in order to prevent inadvertent fluid leaks, as well as to prevent solvent from inadvertently leaking out of the tubing portion <NUM>.

<FIG> is a cross-sectional view of the connector <NUM> of <FIG> including the microbore tubing <NUM> inserted therein, in accordance with some embodiments of the present disclosure. As previously described, the connector <NUM> may include a restriction <NUM>. As illustrated in <FIG>, the restriction <NUM> may include a first end <NUM> defined along the luer profile <NUM> and a second end <NUM> defined along the tubing profile <NUM>. In the depicted embodiments, the second end <NUM> may include a radial projection <NUM> protruding (or otherwise projecting) radially inward and at an angle from the inner circumferential surface <NUM> of the tubing profile <NUM>. The radial projection <NUM> may be configured to dig into, grip, or otherwise engage a first end of the microbore tubing <NUM> to create a seal between the second end <NUM> of the restriction <NUM> and the microbore tubing <NUM> to prevent fluid from inadvertently leaking between the external surface <NUM> of the microbore tubing <NUM> and the inner circumferential surface <NUM> defined in the tubing portion <NUM>. In some embodiments, the radial projection <NUM> is circularly disposed about a central axis X<NUM> of the internal bore <NUM>.

The radial projection <NUM> may form a sealing ring that prevents fluid from inadvertently leaking between the outer surface of the microbore tubing <NUM> and the inner circumferential surface <NUM> defined in the tubing portion <NUM>. In some embodiments, the radial projection <NUM> may be formed with an undercut so as to sufficiently "bite into" or otherwise engage the first end of the microbore tubing <NUM>.

In some embodiments, a maximum distance by which the radial projection <NUM> projects into the internal bore <NUM> is less than or equal to the thickness of the microbore tubing <NUM>. This prevents the radial projection <NUM> from occluding the fluid travelling the tubing inserted into the connector <NUM>. The restriction <NUM> may not be restricted to any particular shape or size as long as the restriction <NUM> prevents the extent of the tubing inserted into the connector <NUM>.

Thus, in some embodiments, the radial projection <NUM> may also act as a retaining mechanism for improving the ability of the connector <NUM> to retain the microbore tubing <NUM> inserted therein and thereby prevent the microbore tubing <NUM> from separating (or otherwise dislodging) from the connector <NUM>, for example, during a low pressure condition in the tubing created due to a reduction in the fluid in the tubing. In an example, and as illustrated, the radial projection <NUM> may be disposed at or adjacent the boundary between the tubing portion and the luer portion <NUM>. As depicted, the radial projection <NUM> may project radially inward a certain distance from the inner circumferential surface <NUM> into the internal bore <NUM> defined in the tubing portion <NUM>. In an example, the radial projection <NUM> may be a spike like structure that extends from the inner circumferential surface <NUM>.

Advantageously, the radial projection <NUM> may thus be a structure that increases friction between the outer surface of the microbore tubing <NUM> and the inner circumferential surface <NUM> such that the microbore tubing <NUM> may not be easily dislodged from the connector <NUM>, without departing from the scope of the disclosure. In some embodiments, the radial projection <NUM> may be structured as a ramp that has a slight undercut configured to slightly compress the microbore tubing <NUM> as it is inserted or advanced into the connector <NUM>. When the microbore tubing <NUM> is pulled to be withdrawn from the connector, the top of the ramp, and in some embodiments the undercut portion, will secure the microbore tubing <NUM> within the connector <NUM> as illustrated in <FIG>. In some embodiments, the top of the ramp, or the undercut portion, will dig into or grip the microbore tubing <NUM> when it is attempted to be withdrawn from within the connector <NUM>, as explained further below.

Referring to <FIG>, with continued reference to <FIG>, the microbore tubing <NUM> may be inserted into the connector <NUM> generally in the direction of arrow A and the radial projection <NUM> may have a tapered distal end <NUM> that is generally oriented in the direction in which the microbore tubing <NUM> is inserted into the connector <NUM>. The microbore tubing <NUM> may be inserted into the connector <NUM> with relative ease. However, the radial projection <NUM> may increase the friction between the connector <NUM> and the microbore tubing <NUM> when a tensile force (direction indicated by the arrow F) is applied on the microbore tubing <NUM> to remove it from the connector <NUM>. Advantageously as a result, the tensile force required to remove or otherwise dislodge the microbore tubing <NUM> from the connector <NUM> is increased and thus the microbore tubing <NUM> is better secured in the connector <NUM>. Further, fluid in the microbore tubing <NUM> may exert pressure in a radially outward direction, which may further increase the friction between the microbore tubing <NUM> and the radial projection <NUM>.

It should be noted that the locations of the radial projection on the inner circumferential surface <NUM> in the Figures are merely examples, and the location may be changed, without departing from the scope of the disclosure. Further, although the Figures indicate one radial projection, the radial projection may be replaced, for example with ledges and/or barbed features, the number of which may not be limited and may be increased or decreased, without departing from the scope of the disclosure. For example, multiple ledges may be disposed at regular intervals along the inner circumferential surface <NUM> in the tubing portion <NUM>. However, in other embodiments, the ledges may be disposed at irregular intervals along the inner circumferential surface <NUM><NUM>. Similarly, multiple barbed features may be disposed at regular intervals along the inner circumferential surface <NUM> in the tubing portion <NUM>. However, in other embodiments, the barbed features may be disposed at irregular intervals. The circumferential extent of barbed features may be around a quarter of a quadrant of the inner circumferential surface <NUM>. However, in other examples, the circumferential extent of the barbed features may be increased or decreased as required by application or design, and without departing from the scope of the disclosure.

<FIG> illustrates core pins <NUM> and <NUM> used to respectively form the tubing profile <NUM> and the luer profile <NUM> on the inner circumferential surface <NUM> of the connector <NUM> of <FIG>, in accordance with some embodiments of the present disclosure. In accordance with some embodiments, the connector <NUM> may be manufactured using an injection molding process. However, other manufacturing processes may also be used to manufacture the connector <NUM>, without departing from the scope of the disclosure. In an example, the core pin <NUM> may form the luer profile <NUM> of the inner circumferential surface <NUM> and the core pin <NUM> may form the tubing profile <NUM> of the inner circumferential surface <NUM>. For the sake of brevity, the processing steps and molds used for creating the features (e.g., grip <NUM>) on the outer surface of the body <NUM> are omitted.

As depicted, core pin <NUM> has a generally elongated body <NUM> having a luer-shaping portion <NUM> and a restriction-shaping portion <NUM>. The luer-shaping portion <NUM> has a generally cylindrical outer surface <NUM> having a diameter larger than the diameter of the restriction-shaping portion <NUM>. The outer surface <NUM> of the luer-shaping portion <NUM> is shaped to form the luer profile <NUM> (illustrated in <FIG>). A restriction-forming profile <NUM> may be formed on the outer surface <NUM> proximate a distal end <NUM> of the luer-shaping portion <NUM>.

In accordance with some embodiments, the core pin <NUM> also has a generally elongated body <NUM> having base portion <NUM> with a cylindrical outer surface <NUM> and a tubing-shaping portion <NUM> having a cylindrical outer surface <NUM>. In some embodiments, the diameter D4 of the base portion <NUM> is greater than the diameter D3 of the tubing-shaping portion <NUM>. The cylindrical outer surface <NUM> is shaped and sized to form the tubing profile <NUM> (<FIG>) of the tubing portion <NUM>. In the depicted embodiments, the cylindrical outer surface <NUM> of the tubing-shaping portion <NUM> may be formed with a plurality of axially extending teeth <NUM> formed along a radial exterior of the outer surface <NUM>. Adjacent teeth <NUM> may define a recess <NUM> therebetween. As shall be described below, during manufacturing, the teeth <NUM> define a shape of the channels <NUM> and the recesses <NUM> define a shape of the axial splines <NUM> of the connector.

In the depicted embodiments, the length of each of the axially extending teeth <NUM> may span a portion of the length of the inner circumferential surface <NUM> of the tubing portion <NUM>. In some embodiments, the length of the axially extending teeth <NUM> spans between about <NUM>% and <NUM>% of the length of the inner circumferential surface <NUM> of the tubing portion <NUM>, more typically between about <NUM>% and <NUM>%, between about <NUM>% and <NUM>%, or in some cases approximately <NUM>% of the length of the inner circumferential surface <NUM> of the tubing portion <NUM>. Since the recesses <NUM> are defined between adjacent axially extending teeth <NUM>, the length of each of the recesses similarly may span between about <NUM>% and <NUM>% of the length of the inner circumferential surface <NUM> of the tubing portion <NUM>, more typically between about <NUM>% and <NUM>%, between about <NUM>% and <NUM>%, or in some cases approximately <NUM>% of the length of the inner circumferential surface <NUM> of the tubing portion <NUM>. Though recited in terms of certain ranges, it will be understood that all ranges from the lowest of the lower limits to the highest of the upper limits are included, including all intermediate ranges or specific percentages, within this full range or any specifically recited ranges.

<FIG> is a cutaway view of the connector (illustrated in phantom) of <FIG> including the core pins <NUM> and <NUM> of <FIG> disposed therein, in accordance with some embodiments of the present disclosure. <FIG> is a cross-sectional view of the connector <NUM> and core pin <NUM> taken along line <NUM>-<NUM> of <FIG>, in accordance with some embodiments of the present disclosure. In accordance with some embodiments, the connector <NUM> may be manufactured using an injection molding process. The connector <NUM> may be made of plastic or similar material that can be molded into a desired shape. An external mold (not illustrated) may be used to create the external features of the connector <NUM>. These external features may include the grip <NUM>, and the outer surface of the cylindrical body <NUM>. The internal bore <NUM>, tubing profile <NUM>, the luer profile <NUM>, the restriction <NUM>, and the radial projection <NUM> may be formed using the core pins <NUM> and <NUM>.

During manufacture, material forming the connector <NUM> may be placed in a molding tool including the core pins <NUM> and <NUM> axially aligned with each other. The core pins <NUM> and <NUM> may be brought together from axially opposite ends into the material. The material may be in a semi-solid, malleable state in order to mold it into a desired shape. The core pins <NUM> and <NUM> may be brought towards each other until the core pins <NUM> and <NUM> couple to each other, as illustrated in <FIG>.

Referring back to <FIG>, the distal end <NUM> of the tubing-shaping portion <NUM> of the core pin <NUM> may include radial projection-forming profile <NUM> including formed as a ring having an inner surface <NUM> angled radially inward and a cavity <NUM> defined therethrough. When the core pins <NUM> and <NUM> are coupled to each other, the distal end <NUM> of the core pin <NUM> is received partially into the cavity <NUM> defined by the radial projection-forming profile <NUM>. In particular, as depicted, the distal end <NUM> of the core pin <NUM> is disposed concentrically with, and radially interior to the inner surface <NUM> of the radial projection-forming profile <NUM>. The restriction-shaping portion <NUM> and the radial projection-forming profile <NUM> cooperatively form the restriction <NUM> and the radial projection. Specifically, when the core pins <NUM> and <NUM> are coupled to each other, a void is formed between the restriction-shaping portion <NUM> and the radial projection-forming profile <NUM>. The void is filled with the semi-solid, malleable connector material and molded into the shape of the void (i.e. the shape of the radial projection <NUM>).

Furthermore, during manufacture, when the core pins <NUM> and <NUM> are coupled to each other and the semi-solid, malleable connector material is placed in the molding tool including the core pins <NUM> and <NUM> axially aligned with each other, the axially extending teeth <NUM> may pierce into the semi-solid, malleable connector material and form an imprint therein. The semi-solid, malleable connector material may also fill the recesses <NUM> and be molded into a shape defined by the recesses <NUM>. Once the semi-solid, malleable connector material has solidified, the core pins <NUM> and <NUM> are removed. When the core pin <NUM> is removed axially extending recesses are created along the inner circumferential surface <NUM> of the tubing portion <NUM> where the axially extending teeth <NUM> pierced into the connector material. The axially extending channels correspond to the axially extending channels <NUM> in the tubing profile <NUM> of the tubing portion <NUM>. Similarly, when the core pin <NUM> is removed axially extending splines project along the inner circumferential surface <NUM> of the tubing portion <NUM> where the semi-solid, malleable connector material filled the recesses <NUM>. The filled recesses <NUM> correspond to the axial splines <NUM> formed on the tubing profile <NUM> of the tubing portion <NUM>.

As previously described, in some embodiments, the depth of each of the channels <NUM> tapers in a direction towards the tubing port <NUM>. The tapering of the depth of each of the channels <NUM> is due to the configuration of the tubing profile <NUM>. For example, as depicted, the diameter D1 of the internal bore <NUM> at the end of the tubing profile <NUM> adjacent to the restriction <NUM> is smaller than the diameter D2 of internal bore <NUM> at the end of the tubing profile <NUM> adjacent to the tubing port <NUM>. As such, the tubing profile <NUM> tapers in a direction from the end adjacent to the tubing port <NUM> to the end adjacent to the restriction <NUM>. When the core pin <NUM> having the axially extending teeth <NUM> is positioned in the mold with the material used to form the connector <NUM>, the teeth <NUM> dig deeper into the connector material in the area of the tubing profile adjacent to the restriction <NUM> (due to the smaller diameter D1) and dig progressively less into the connector material in the direction of the tubing port <NUM> (due to the diameter increasing to D2 in the direction of the tubing port). Since the teeth <NUM> dig deeper into the connector material in the area of the tubing profile <NUM> adjacent to the restriction <NUM>, the resulting channels <NUM> have a greater depth and the resulting axial splines have a greater height in this area than in the area approaching the tubing port <NUM>.

The aforementioned configuration is advantageous in that axial splines <NUM> are able to bite into or grip the microbore tubing <NUM> to a greater degree in the area of the tubing profile adjacent to the restriction <NUM>, thereby necessitating a relatively stronger tensile force to be exerted on the microbore tubing <NUM> to separate or dislodge the microbore tubing <NUM> from the connector <NUM>. Thus, accidental separation of the microbore tubing <NUM> from the connector <NUM> may be minimized.

In accordance with some embodiments, an angle α between the first inclined side <NUM> and the second inclined side <NUM> of adjacent splines ranges from about <NUM> degrees to <NUM> degrees, more typically about <NUM> degrees to <NUM> degrees, and <NUM> degrees to <NUM> degrees, or in some cases approximately <NUM> degrees. Though recited in terms of certain ranges, it will be understood that all ranges from the lowest of the lower limits to the highest of the upper limits are included, including all intermediate ranges or specific angles, within this full range or any specifically recited range.

In some embodiments, similar to the axial splines <NUM>, a depth of each of the recesses <NUM> may range from about <NUM> inches to <NUM> inches, more typically about <NUM> inches to <NUM> inches, <NUM> inches to <NUM> inches, or in some cases approximately <NUM> inches. Accordingly, similar to the axial channels <NUM>, a height H of each of the axially extending teeth <NUM> may range from about <NUM> inches to <NUM> inches, more typically about <NUM> inches to <NUM> inches, <NUM> inches to <NUM> inches, or in some cases approximately <NUM> inches. Though recited in terms of certain ranges, it will be understood that all ranges from the lowest of the lower limits to the highest of the upper limits are included, including all intermediate ranges or specific dimensions, within this full range or any specifically recited range.

While the foregoing has described what are considered to be the best mode and/or other examples, it is understood that various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein, but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more. " Unless specifically stated otherwise, the terms "a set" and "some" refer to one or more.

It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

Terms such as "top," "bottom," "front," "rear" and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

Claim 1:
A connector (<NUM>) comprising:
a body (<NUM>) having a tubing portion (<NUM>), a luer portion (<NUM>) axially opposite the tubing portion (<NUM>) and connected thereto; and
an inner circumferential surface (<NUM>) defining an internal bore (<NUM>) of the connector (<NUM>), the inner circumferential surface (<NUM>) extending axially between the tubing portion (<NUM>) and the luer portion (<NUM>) and the internal bore (<NUM>) being in fluid communication with the tubing portion (<NUM>) and the luer portion (<NUM>),
wherein, the inner circumferential surface (<NUM>) comprises a plurality of splines (<NUM>) extending axially along a length of the inner circumferential surface (<NUM>) in the tubing portion (<NUM>) of the connector (<NUM>) and each pair of adjacent splines of the plurality of splines (<NUM>) define a channel (<NUM>) therebetween and a depth of each of the channels (<NUM>) tapers in a direction towards a port (<NUM>) of the tubing portion (<NUM>), and
wherein:
the inner circumferential surface (<NUM>) is configured to engage an external surface of a tubing (<NUM>) in a coupled configuration; and
in the coupled configuration, edges (<NUM>) of the splines (<NUM>) grip and engage the external surface of the tubing (<NUM>) to retain the tubing (<NUM>) in the body (<NUM>).