Luer having a microbore tube holding pocket joint with an axial spline

Abstract

To provide a medical connector preventing separation of tubing from a connector, and preventing fluid from inadvertently leaking between the tubing and the connector.SOLUTION: A connector is provided which comprises: a body having a tubing portion, and a luer portion located 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 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.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present disclosure generally relates to medical connectors, and more particularly to a retaining mechanism for preventing a tube coupled to a medical connector from becoming detached or separated from the connector due to a reduction in fluid within the tube, and a sealing mechanism for preventing fluid from accidentally leaking between the tube and the connector.

Background Art

[0002] In the medical field, fluids are frequently administered as infusions. A container holding a 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 that includes a tube having one or more fittings or connectors. The IV set may further have intermediate ports or connection points where additional fluid containers may be connected to introduce or withdraw fluid. The tube is connected to the fitting or connector by means of one or more mechanical attachments inserted inside the tube and by connection techniques such as solvent weld between an internal pocket of the fitting and the external surface of the tube.

[0003] Medical connectors are widely used in fluid delivery systems such as those used for connection to intravenous (IV) fluid lines, blood access, hemodialysis, peritoneal dialysis, enteral nutrition, drug vial access, and the like. Medical connectors can generally connect two fluid lines or tubes.

Summary of the Invention

[0004] A medical connector may be a hollow tubular structure for receiving a fluid line or tube at one of its ends. The connector provides a flow path for fluid entering from the tube to exit the connector to the outside from the opposite end. The presence of fluid within the tube can create an airtight seal between the outer surface of the tube and the inner surface of the medical connector. The airtight seal can prevent the tube from separating from the medical connector. However, when there is no fluid in the tube or when the amount of fluid in the tube decreases, the airtight seal may become brittle, and the tube may easily separate from the connector, thereby potentially causing a "free flow leak".

[0005] Furthermore, when a microbore tube is used, minimizing the surface area of the microbore tube for joining creates further problems in holding the microbore tube within the connector.

[0006] According to various embodiments of the present disclosure, a connector has a body having a tube portion and a luer portion that is axially opposite the tube portion and connected to the tube portion, and an inner circumferential surface that defines an inner bore of the connector. The inner circumferential surface extends axially between the tube portion and the luer portion, and the inner bore is in fluid communication with the tube portion and the luer portion. The inner circumferential surface has a plurality of splines that extend axially along the length of the inner circumferential surface within the tube portion of the connector. The inner circumferential surface is configured to engage the outer surface of the tube in a coupling configuration. In the coupling configuration, the edges of the splines grip and engage the outer surface of the tube to hold the tube within the body.

[0007] According to various embodiments of the present disclosure, a connector has a body having a tube profile and a luer profile that is axially opposite the tube portion and connected to the tube portion, a restriction portion inserted between the luer profile and the tube profile, and an inner circumferential surface that defines an inner bore at least within the tube profile. The restriction portion has a first end along the luer profile, a second end along the tube profile, and a protrusion extending axially from the second end, the protrusion extending into the inner bore. The inner circumferential surface is configured to engage the outer surface of the tube in a coupled configuration. In the coupled configuration, the protrusion grips the tube to form a seal between the second end of the restriction portion and the tube.

[0008] The following figures are included to illustrate specific aspects of the embodiments and should not be regarded as exclusive embodiments. The disclosed subject matter is capable of considerable modification, alteration, combination, and equivalents in form and function, as will occur to one of ordinary skill in the art and fall within the scope of the present disclosure.

Brief Description of the Drawings

[0009]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

DETAILED DESCRIPTION OF THE INVENTION

[0010] Various embodiments of the present disclosure are directed to providing a connector with enhanced tube retention for an IV set that uses a microbore tube having a minimum surface area for joining.

[0011] Various embodiments of the present disclosure are further directed to providing a connector having improved sealing ability to prevent accidental leakage of fluid between the outer surface of a tube (e.g., a microbore tube) and the inner surface of the connector.

[0012] The disclosed embodiments are directed to a connector having a retention mechanism for preventing a microbore tube coupled to the connector from becoming disengaged from and / or separated from the connector in the absence (or reduction) of fluid within the tube. The embodiments disclosed herein are further directed to a connector having a restriction mechanism for retaining a tube within the connector and for sealing between the tube and the inner surface of the connector. As disclosed herein, the retention mechanism can have a plurality of splines that extend axially along the inner circumference of the tube portion of the connector. When a fluid line (tube) is inserted into the tube portion, the edges of the axial splines bite into the tube to grip the tube in order to enhance tube retention within the tube portion of the connector. For example, the fluid line can be inserted into the tube portion by an interference fit, such that the outer diameter of the fluid line is slightly larger than the inner diameter of the tube portion. As a result, a relatively large tensile force needs to be applied to the tube in order to separate or remove the tube from the connector. Thus, the inadvertent separation of the tube can be minimized.

[0013] Further, advantageously, adjacent splines define corresponding recesses or channels therebetween that extend axially along the inner circumference of the tube portion of the connector. Thus, a large amount of solvent for joining the fluid line or tube to the tube portion can be collected within the channels for a maximum level of joining. This ensures that the solvent spreads uniformly and eliminates the possibility of the fluid being crushed on the joining surface. This is in contrast to the conventional joining technique between a connector and a fluid line, where the solvent flows into the connector and is crushed by the tube when the tube is inserted into the connector, thereby reducing the surface area of the solvent between the tube and the connector for joining.

[0014] As disclosed herein, the restraint mechanism can have, as an alternative, a spined fitting, a serrated edge, or a similar structure that can hold a radial protrusion, a sealing ring, or a tube. The restraint mechanism ensures maintaining a seal between the tube and the inner surface of the connector during a low-pressure state (e.g., in the absence of fluid within the tube). This is because an interference fit is formed between the tube and the connector. As a result, it is necessary to apply a relatively large tensile force to the tube to separate or remove the tube from the connector. Thus, the accidental separation of the tube can be minimized.

[0015] In some embodiments, the restraint mechanism can have one or more radial protrusions or projections on the inner surface of the connector that limit the extent of the tube's extension within the connector when the tube is inserted into the connector. As will be discussed later, the connector at the end opposite the end that receives the tube can have a female luer fitting. The restraint mechanism prevents the tube from extending into the female luer fitting during assembly, thereby ensuring the correct operation of the medical connector.

[0016] Another advantage of the medical connector according to the disclosed embodiments is that the manufacturing cost of the medical connector does not increase significantly. Existing manufacturing equipment can be modified at minimal cost to manufacture the exemplary medical connector. For example, the core pins of the injection molding equipment used to manufacture the medical connector can be redesigned to create the axial splines and channels, as well as the restraint mechanism.

[0017] As used herein, the terms "tube," "fluid line," and any variations thereof mean a medical line or medical tube used to deliver or receive a liquid, solvent, or fluid (including gas) to or from a patient under medical care. For example, a fluid line (tube) can be used for intravenous (IV) delivery of fluids, fluid drainage, oxygen transport, and combinations thereof.

[0018] As used herein, the terms "medical connector", "connector", "fitting", and any variations thereof mean any device used to provide a fluid flow path between two or more fluid lines coupled to the connector. For example, the medical connector may be a bond pocket or other type of connector or may have a bond pocket or other type of connector.

[0019] FIG. 1 depicts a perspective view of an IV set 10 having a medical connector 100 that can employ the principles of the present disclosure, according to some embodiments of the present disclosure. As depicted, the IV set can have a fluid source, such as a fluid bag 2, that can have or contain saline or other fluid to be administered to a patient. As shown, a first tube 6 carries fluid flow from the drip chamber 4 through the connector 100 and into a second fluid line or tube 170. An IV pump (not shown) receives fluid from the fluid system 2 via the second tube 170 and controls the fluid therefrom to meter and distribute it to the patient. As will be described in more detail later, the tubular portion of the connector 100 has an internal bore configured to receive the second tube 170. In the present disclosure, the second tube 170 is described as a microbore tube or a small bore tube, and thus the connector 100 is described as being configured to receive and hold the microbore tube. However, the various embodiments of the connector described herein can be applied to other types of tubes, such as, for example, a macro bore tube or a large bore tube.

[0020] FIG. 2 shows a cross-sectional view of the medical connector 100 of FIG. 1 according to the disclosed embodiments. As shown, the medical connector 100 (or simply the connector) can have a generally cylindrical body 101 having a “first” portion or tube portion 103 and a “second” portion or luer portion 105 that is axially opposite the tube portion 103 and connected to the tube portion 103. In some embodiments, the body 101 can further have a grip 107 disposed along the outer surface of the body 101. The tube portion 103 can have a tube port 120 sized and shaped or otherwise configured to receive a fluid line (hereinafter referred to as a “tube”). Similarly, the luer portion 105 can have a luer port 125 sized and shaped or otherwise configured to receive a male luer connector. As depicted, the body 101 defines a longitudinal internal passage or bore 140 that extends from the tube port 120 to the luer port 125 and fluidly connects the tube port 120 and the luer port 125 to each other.

[0021] In the illustrated embodiment, an internal bore 140 is defined by an inner circumferential surface 112 of the body 101 and extends from the tube port 120 to the luer port 125. In some embodiments, the inner circumferential surfaces 112 in the tube portion 103 and the luer portion 105 have two dissimilar profiles. Specifically, the inner circumferential surface 112 within the tube portion 103 has a tube profile 135, and the inner circumferential surface 115 within the luer portion 105 has a luer profile 133. The tube profile of the connector 100 and thus the tube portion 103 are sized and shaped (or otherwise configured) to receive a tube. Specifically, the tube profile 135 can be sized, shaped, and otherwise configured to receive a microbore tube 170 (to be described in more detail later). For example, a tube having an inner diameter of less than 0.254 cm (0.100 inch), and specifically a tube having an outer diameter of about 0.201 cm (0.079 inch) or less, is considered a "small bore" or "microbore" and is joined into a tube pocket such as the internal bore 140 defined within the tube profile 135. A tube having an inner diameter greater than 0.254 cm (0.100 inch) is typically considered a "macro bore". The exemplary embodiments of the present disclosure are shown and described in relation to tubes in the form of "small bore" or "microbore" tubes and pocket joints for "small bore" or "microbore" tubes. However, the various embodiments of the present disclosure are not limited to only the configurations mentioned above and can equally apply to "large bore" or "macro bore" tubes and associated connectors, and further to any other intermediate sized tubes and any other connectors between "microbore" connectors and "macro bore" connectors. The luer profile 133 of the connector 100 and thus the luer portion 105 can be sized and shaped (or otherwise configured) to receive a male luer fitting. The luer profile 133 and thus the luer portion 105 can be ISO-594 compliant.

[0022] During assembly, the inner circumferential surface 115 can have a limiting mechanism (hereinafter referred to as "restriction 130") to limit the extent to which a tube is inserted into, advances through, or otherwise "slides into" the connector 100. The restriction 130 can be defined to project radially inward from the inner circumferential surface 115 and can be interposed between the luer profile 133 and the tube profile 135. In some embodiments, the restriction 115 functions as a stop for insertion of the tube into an internal bore 140 defined within the luer profile 133. Thus, the restriction 130 can have a diameter D2 (shown in FIG. 6) that is less than the minimum diameter D1 of the internal bore 140 defined within the tube profile 135.

[0023] According to some embodiments, the tube profile 135 of the tube portion 103 can have a retention mechanism for holding the microbore tube 170 inserted into the connector 100 and thus for preventing the microbore tube 170 from separating (or otherwise disengaging) from the connector 100, thereby improving the ability of the connector 100. For example, the retention mechanism can prevent the microbore tube 170 from separating (or otherwise disengaging) from the connector 100 during a low pressure condition within the tube caused by a reduction in fluid within the tube. As an example, as shown, the retention mechanism can be or can have a plurality of splines 115 that extend axially along the inner circumferential surface 112 of the tube portion 130 of the connector 100. When the microbore tube 170 (shown in FIG. 5) is inserted into the tube portion 103 of the connector 100, the inner circumferential surface 112 within the tube portion 103 is configured to engage the outer surface of the microbore tube 170 in a coupling configuration. For example, when the microbore tube 170 is inserted into the tube portion 103, the edges 135 of the axial splines 115 can bite into the outer surface of the tube and grip the outer surface of the tube to enhance tube retention within the tube portion of the connector. Thus, in the coupling configuration, the microbore tube 170 can be inserted into the tube portion by interference fit, such that the edges 135 of the axial splines 115 bite into the outer surface of the microbore tube 170, grip the outer surface of the microbore tube 170, engage the outer surface of the microbore tube 170, thereby retaining the microbore tube 170 within the tube portion 103 of the connector 100. The configuration mentioned above has the advantage that, without departing from the scope of the present disclosure, when the edges 135 of the axial splines 115 bite into the outer surface of the microbore tube 170, grip the outer surface of the microbore tube 170, and engage the outer surface of the microbore tube 170, the friction between the microbore tube 170 and the inner circumferential surface 112 increases, and as a result, the microbore tube 170 cannot be easily disengaged from the connector 100.For example, when a tensile force (in the direction indicated by the arrow F shown in FIG. 5) is applied to the microbore tube 170 to attempt to remove the microbore tube 170 from the connector 100 by biting into or digging into the outer surface of the microbore tube 170, the axial spline can increase the friction between the connector 100 and the microbore tube 170. As a result, advantageously, the tensile force required to remove or otherwise disengage the microbore tube 170 from the connector 100 is increased, and thus the microbore tube 170 is better fixed and held within the connector 100. Further, the fluid within the microbore tube 170 can exert a pressure in the radially outward direction, thereby further increasing the friction between the microbore tube 170 and the inner circumferential surface 112.

[0024] According to some embodiments, adjacent splines 115 define corresponding recesses or channels 145 therebetween. Similarly, channels 145 extend axially along the inner circumferential surface 112 of the tube portion 103 of the connector 100. Advantageously, a large amount of solvent for joining the microbore tube 170 to the inner circumferential surface 135 defined within the tube portion 103 can be collected in the channels 145 for maximum level of joining. Specifically, by collecting the solvent within the channels 145, it becomes possible to utilize a large amount of solvent to join the microbore tube 170 to the inner circumferential surface 135 of the tube portion 103. By collecting the solvent in the channels 145, the solvent will spread uniformly, eliminating the possibility of the fluid being crushed on the joining surface of the tube portion 103. Thus, the maximum amount of solvent used to join the microbore tube 170 to the inner circumferential surface 135 of the tube portion 103 will remain, and further enhanced tube retention can be achieved. This is in contrast to conventional connector and tube joining techniques, where the solvent flows into the connector and is crushed by the tube when the fluid line / tube is inserted into the connector, thereby reducing the surface area of the solvent between the tube and the connector.

[0025] FIG. 3 is a partial cross-sectional view of the axial splines and channels of the tube section of the connector of FIG. 2, according to some embodiments of the present disclosure. FIG. 4 is an enlarged partial view showing the axial splines and channels of the tube section of the connector of FIG. 2, according to some embodiments of the present disclosure.

[0026] Referring to FIGS. 3 and 4 and continuing to refer to FIG. 2, each axial spline can be defined by a first inclined surface 117, a second inclined surface 119, and an edge 135 interposed between the first inclined surface 117 and the second inclined surface 119. As depicted, the axial spline can be formed as the tooth shape of a spline gear. Since a channel 145 is defined between adjacent splines 115, each channel 145 is defined by adjacent first inclined surfaces 117 and second inclined surfaces 119 that intersect at an apex 121. However, the shapes of the axial splines 115 and the channels 145 are not limited to only the configurations mentioned above. For example, as long as the axial spline 115 "engages" into the outer surface of the microbore tube 170, "protrudes" into the outer surface of the microbore tube 170, grips the outer surface of the microbore tube 170, or engages with the outer surface of the microbore tube 170 in some other form, and as long as the channel 145 forms a recess having a depth sufficient to accommodate a solvent therein, the axial splines 115 and the channels 145 need not be limited to any particular shape or size.

[0027] According to some embodiments, the axial splines 115 and the channels 145 can be arranged at regular intervals along the inner circumferential surface 112 of the tube portion 103. However, in other embodiments, the axial splines 115 and the channels 145 may be arranged at irregular intervals along the inner circumferential surface 112 of the tube profile 135.

[0028] According to some embodiments, the angle α between the first inclined side surface 117 and the second inclined side surface 119 of adjacent splines is in the range of from about 30 degrees to 150 degrees, more generally from about 60 degrees to 120 degrees, or from 80 degrees to 100 degrees, or in some cases about 90 degrees. Although specific ranges are recited, it is to be understood that all ranges from the smallest value of the lower limit to the largest value of the upper limit are included, including all intermediate ranges or specific angles within this entire range or within any specifically recited range.

[0029] In some embodiments, the height of each spline, measured from vertex 121 to the edge 135 of each spline, may be in the range of from about 0.000254 cm (0.0001 inches) to 0.00508 cm (0.002 inches), more typically from about 0.00127 cm (0.0005 inches) to 0.00495 cm (0.00195 inches), or from 0.00254 cm (0.001 inches) to 0.00508 cm (0.002 inches), or in some cases may be about 0.00381 cm (0.0015 inches). Thus, the depth of each channel 145 defined by adjacent splines 115 may be in the range of from about 0.000254 cm (0.0001 inches) to about 0.00508 cm (0.002 inches), more typically from about 0.00127 cm (0.0005 inches) to 0.00495 cm (0.00195 inches), or from 0.00254 cm (0.001 inches) to 0.00508 cm (0.002 inches), or in some cases may be about 0.00381 cm (0.0015 inches). Although specific ranges are recited, it is to be understood that all ranges from the smallest value of the lower limit to the largest value of the upper limit are included, including all intermediate ranges or specific dimensions within this entire range or any specifically recited range.

[0030] In some embodiments, the depth of each channel is tapered (i.e., decreasing in width or gradually reducing) in the direction towards the tube port 120. For example, each channel 145 may have a maximum depth in the region adjacent to the second end 155 of the restriction 130. As the channel 145 approaches the tube port 120, the depth of each channel 145 may gradually decrease until each channel 145 terminates.

[0031] Referring again to FIG. 2, the length of each axial spline 115 extends over a portion of the length of the inner circumferential surface 112 of the tube portion 103. In some embodiments, the length of the axial spline 115 extends between about 10% and 90% of the length of the inner circumferential surface 112 of the tube portion 103, more typically between about 25% and 75%, between about 40% and 60%, or in some cases about 50% of the length of the inner circumferential surface 112 of the tube portion 103. Due to the channels 145 being defined between adjacent axial splines 115, the length of each channel 145 may similarly extend between about 10% and 90% of the length of the inner circumferential surface 112 of the tube portion 103, more typically between about 25% and 75%, between about 40% and 60%, or in some cases about 50% of the length of the inner circumferential surface 112 of the tube portion 103. Although specific ranges are recited, it is to be understood that all ranges from the smallest of the lower limits to the largest of the upper limits are included, including all intermediate ranges or specific percentages within this entire range or any specifically recited range. To prevent accidental fluid leakage, and further to prevent accidental solvent leakage from the tube portion 103, it is advantageous for the channels not to extend all the way across the tube port.

[0032] FIG. 5 is a cross-sectional view of the connector 100 of FIG. 2 having a microbore tube 170 inserted therein, according to some embodiments of the present disclosure. As described above, the connector 100 can have a restriction portion 130. As shown in FIG. 5, the restriction portion 130 can have a first surface 150 defined along a luer profile 133 and a second surface 155 defined along a tube profile 135. In the illustrated embodiment, the second surface 155 can have a radially protruding portion 160 that protrudes (or otherwise projects) at a constant angle radially inward from the inner circumferential surface 112 of the tube profile 135. The radially protruding portion 160 can be configured to bite into, grip, or otherwise engage the first end of the microbore tube 170, thereby forming a seal between the second surface 155 of the restriction portion 130 and the microbore tube 170, thereby preventing accidental fluid leakage between the outer surface 172 of the microbore tube 170 and the inner circumferential surface 112 defined within the tube portion 103. In some embodiments, the radially protruding portion 160 is circularly arranged about the central axis X1 of the inner bore 140.

[0033] The radially protruding portion 160 can form a sealing ring that prevents accidental fluid leakage between the outer surface of the microbore tube 170 and the inner circumferential surface 112 defined within the tube portion 103. In some embodiments, the radially protruding portion 160 can be formed to have serrations for sufficiently "biting in" or otherwise sufficiently engaging the first end of the microbore tube 170.

[0034] In some embodiments, the maximum distance that the radial protrusion 160 protrudes into the inner bore 140 is less than or equal to the thickness of the microbore tube 170. Thereby, it is prevented that the radial protrusion 160 obstructs the fluid from moving through the tube inserted into the connector 100. As long as the restricting portion 130 prevents the inserted tube from extending within the connector 100, the restricting portion 130 does not have to be limited to a specific shape or size.

[0035] Accordingly, in some embodiments, the radial protrusion 160 can further function as a retaining mechanism for holding the microbore tube 170 inserted therein and thereby preventing the microbore tube 170 from separating (or otherwise disengaging) from the connector 100 during a low-pressure state within the tube caused, for example, by a reduction in the fluid within the tube. In an example, as shown, the radial protrusion 160 can be disposed at or adjacent to the boundary between the tube portion and the luer portion 105. As depicted, the radial protrusion 160 can protrude radially inward from the inner circumferential surface 112 into the inner bore 140 defined within the tube portion 103 by a certain distance. In an example, the radial protrusion 160 can be a spike-like structure extending from the inner circumferential surface 115.

[0036] Accordingly, advantageously, the radial protrusion 160 may be configured to increase the friction between the outer surface of the microbore tube 170 and the inner circumferential surface 112, such that, without departing from the scope of the present disclosure, the microbore tube 170 cannot be easily detached from the connector 100. In some embodiments, the radial protrusion 160 may be configured as an inclined portion having slight indentations configured to slightly compress the microbore tube 170 when the microbore tube 170 is inserted into or advanced into the connector 100. When the microbore tube 170 is pulled and withdrawn from the connector, the top portion of the inclined portion, and in some embodiments the indentation portion, will fix the microbore tube 170 within the connector 100 as shown in FIG. 5. In some embodiments, as will be further described later, when attempting to withdraw the microbore tube 170 from within the connector 100, the top or indentation portion of the inclined portion will bite into or grip the microbore tube 170.

[0037] Referring to FIG. 5 and continuing to refer to FIG. 2, the microbore tube 170 can generally be inserted into the connector 100 in the direction of arrow A, and the radially projecting portion 160 can have a tapered distal end 162 that is generally oriented in the direction of inserting the microbore tube 170 into the connector 100. The microbore tube 170 can be inserted into the connector 100 relatively easily. However, when a tensile force (in the direction indicated by arrow F) is applied to remove the microbore tube 170 from the connector 100, the radially projecting portion 160 can increase the friction between the connector 100 and the microbore tube 170. As a result, advantageously, the tensile force required to attempt to remove the microbore tube 170 from the connector 100 or otherwise remove it is increased, and thus the microbore tube 170 is better fixed within the connector 100. Further, the fluid within the microbore tube 170 can exert a pressure in the radially outward direction, thereby further increasing the friction between the microbore tube 170 and the radially projecting portion 160.

[0038] Note that the location of the radial protrusions on the inner circumferential surface 112 in the figure is merely an example, and this location can be changed without departing from the scope of the present disclosure. Further, although the figure shows one radial protrusion, the radial protrusion may be replaced with, for example, a protrusion and / or a serrated structure, and the number thereof need not be limited and may be increased or decreased without departing from the scope of the present disclosure. For example, a plurality of protrusions may be arranged at regular intervals along the inner circumferential surface 122 within the tube portion 103. However, in other embodiments, the protrusions may be arranged at irregular intervals along the inner circumferential surface 112. Similarly, a plurality of serrated structures may be arranged at regular intervals along the inner circumferential surface 122 within the tube portion 103. However, in other embodiments, the serrated structures may be arranged at irregular intervals. The circumferential extent of the serrated structure may be about one-fourth of a quadrant of the inner circumferential surface 112. However, in other examples, the circumferential extent of the serrated structure may be increased or decreased as required by the application or design without departing from the scope of the present disclosure.

[0039] FIG. 6 shows core pins 201 and 203 used to form a tube profile 135 and a luer profile 133, respectively, on an inner circumferential surface 112 of the connector 100 of FIG. 2, according to some embodiments of the present disclosure. According to some embodiments, the connector 100 can be manufactured using an injection molding process. However, without departing from the scope of the present disclosure, other manufacturing processes may be utilized to manufacture the connector 100. In an example, the core pin 201 can form the luer profile 133 of the inner circumferential surface 112, and the core pin 203 can form the tube profile 135 of the inner circumferential surface 112. For the sake of brevity, the processing steps and molds utilized to create the structures (e.g., the grip 107) on the outer surface of the body 101 are omitted.

[0040] As depicted, the core pin 201 has a generally elongated body 202 having a lure forming portion 206 and a restriction portion forming portion 208. The lure forming portion 206 has a generally cylindrical outer surface 212 having a diameter larger than the diameter of the restriction portion forming portion 208. The outer surface 212 of the lure forming portion 206 is shaped to form a lure profile 133 (shown in FIG. 2). A restriction portion forming profile 210 may be formed on the outer surface 212 in the vicinity of the distal end 211 of the lure forming portion 206.

[0041] According to some embodiments, the core pin 203 further has a generally elongated body 222 having a base portion 225 having a cylindrical outer surface 226 and a tube forming portion 220 having a cylindrical outer surface 222. In some embodiments, the diameter D4 of the base portion 225 is larger than the diameter D3 of the tube forming portion 220. The cylindrical outer surface 222 is shaped and sized to form a tube profile 135 (FIG. 2) of the tube portion 103. In the depicted embodiment, the cylindrical outer surface 222 of the tube forming portion 220 may be formed to have a plurality of axially extending teeth 224 formed along a radially outer portion of the outer surface 222. Adjacent teeth 224 can define a recess 215 therebetween. As will be described later, during manufacture, the teeth 224 define the shape of the channel 145 and the recesses 215 define the shape of the axial splines 115 of the connector.

[0042] In the illustrated embodiment, the length of each axially extending tooth 224 may extend over a portion of the length of the inner circumferential surface 112 of the tube portion 103. In some embodiments, the length of the axially extending tooth 224 may extend between about 10% and 90%, more typically between about 25% and 75%, between about 40% and 60% of the length of the inner circumferential surface 112 of the tube portion 103, or in some cases about 50% of the length of the inner circumferential surface 112 of the tube portion 103. Due to the recess 215 being defined between adjacent axially extending teeth 224, the length of each recess may similarly extend between about 10% and 90%, more typically between about 25% and 75%, between about 40% and 60% of the length of the inner circumferential surface 112 of the tube portion 103, or in some cases about 50% of the length of the inner circumferential surface 112 of the tube portion 103. Although specific ranges are recited, all ranges from the smallest of the lower limits to the largest of the upper limits are included, and this includes all intermediate ranges or specific percentages within this entire range or any specifically recited range.

[0043] FIG. 7 is a cutaway view showing the connector of FIG. 2 (shown in phantom lines) having the core pins 201 and 203 of FIG. 6 disposed therein, according to some embodiments of the present disclosure. FIG. 8 is a cross-sectional view of the connector 100 and the core pin 203 along line 8 - 8 of FIG. 7, according to some embodiments of the present disclosure. According to some embodiments, the connector 100 may be manufactured using an injection molding process. The connector 100 may be made of plastic or a similar material that can be molded into the desired shape. An external mold (not shown) may be used to create the external structure of the connector 100. These external structures may include the grip 107 and the outer surface of the cylindrical body 101. The internal bore 140, the tube profile 135, the luer profile 133, the restriction 130, and the radially projecting portion 160 may be formed using the core pins 201 and 203.

[0044] During manufacturing, the material forming the connector 100 is placed into a molding tool having core pins 201 and 203 that are axially aligned with each other. The core pins 201 and 203 can be simultaneously fed into the material from opposite ends axially. The material may be in a semi-solid malleable state so that it can be formed into the desired shape. The core pins 201 and 203 are fed towards each other and ultimately the core pins 201 and 203 are joined as shown in FIG. 7.

[0045] Referring again to FIG. 6, the distal end 219 of the tube forming portion 220 of the core pin 203 can have a profile 228 forming a radially projecting portion that includes a radially inwardly angled inner surface 229 and a cavity 230 defined to pass therethrough formed as a ring. When the core pins 201 and 203 are joined to each other, the distal end 218 of the core pin 201 is partially received within the cavity 230 defined by the profile 208 forming a radially projecting portion. Specifically, as depicted, the distal end 218 of the core pin 201 is concentrically disposed radially inward of the inner surface 229 of the profile 228 forming a radially projecting portion. The restriction forming portion 208 and the profile 228 forming a radially projecting portion cooperate to form the restriction 130 and the radially projecting portion. Specifically, when the core pins 201 and 203 are joined to each other, a void is formed between the restriction forming portion 208 and the profile 228 forming a radially projecting portion. The void is filled with the semi-solid malleable material of the connector and the material of the connector is formed into the shape of this void (i.e., the shape of the radially projecting portion 160).

[0046] Further, during manufacture, when the core pins 201 and 203, which are coupled to each other and have a connector material with semi-solid malleability, are placed in a molding tool having core pins 201 and 203 that are axially aligned with each other, axially extending teeth 224 punch holes in this connector material with semi-solid malleability to form imprints therein. The material with semi-solid malleability can further fill the recess 215 and can be shaped into the shape defined by the recess 215. When the connector material with semi-solid malleability solidifies, the core pins 201 and 203 are removed. When the core pin 203 is removed, a recess axially extending along the inner circumferential surface 112 of the tube portion 103 is created, which is where the axially extending teeth 224 punched a hole in the connector material. The axially extending channel corresponds to the axially extending channel 145 within the tube profile 135 of the tube portion 103. Similarly, when the core pin 203 is removed, axially extending splines project along the inner circumferential surface 112 of the tube portion 103, which is where the connector material with semi-solid malleability filled the recess 215. The filled recess 215 corresponds to the axial splines 115 formed on the tube profile 135 of the tube portion 103.

[0047] As described above, in some embodiments, the depth of each channel 145 is tapered in the direction towards the tube port 109. The depth of each channel 145 being tapered is due to the configuration of the tube profile 135. For example, as depicted, the diameter D1 of the inner bore 140 at the end of the tube profile 135 adjacent to the restriction portion 130 is smaller than the diameter D2 of the inner bore 140 at the end of the tube profile 135 adjacent to the tube port 120. Thus, the tube profile 135 is tapered in the direction from the end adjacent to the tube port 120 towards the end adjacent to the restriction portion 130. When a core pin 203 having axially extending teeth 224 is placed within a mold having the material used to form the connector 100, the teeth 224 bite deeply into the connector material within the area of the tube profile adjacent to the restriction portion 130 (due to the smaller diameter D1), and this depth of bite into the connector material gradually decreases towards the tube port 120 (because the diameter increases to D2 towards the tube port). In the area of the tube profile 135 adjacent to the restriction portion 130, since the teeth 224 bite deeply into the connector, in this area, the resulting channel 145 has a greater depth than the area closer to the tube port 120, and the resulting axial spline has a greater height.

[0048] The configuration mentioned above is advantageous in that the axial spline 115 can bite deeper into or grip the microbore tube 170 in the area of the tube profile adjacent to the restriction portion 130, whereby a relatively large tensile force needs to be applied to the microbore tube 170 to separate or remove the microbore tube 170 from the connector 100. Thus, the accidental separation of the microbore tube 170 from the connector 100 can be minimized.

[0049] According to some embodiments, the axial splines 115 and channels 145 may be disposed at regular intervals along the inner circumferential surface 112 of the tube portion 130. However, in other embodiments, the axial splines 115 and channels 145 may be disposed at irregular intervals along the inner circumferential surface 112 of the tube profile 135.

[0050] According to some embodiments, the angle α between the first inclined side surface 117 and the second inclined side surface 119 of adjacent splines is in the range of about 30 degrees to 150 degrees, more typically about 60 degrees to 120 degrees, or 80 degrees to 100 degrees, or in some cases about 90 degrees. Although specific ranges are recited, all ranges from the smallest of the lower limits to the largest of the upper limits are included, and it is to be understood that this includes all intermediate ranges or specific angles within this entire range or any specifically recited range.

[0051] In some embodiments, similar to the axial spline 115, the depth of each recess 215 may range from about 0.000254 cm (0.0001 inch) to 0.00508 cm (0.002 inches), more typically from about 0.00127 cm (0.0005 inch) to 0.00495 cm (0.00195 inches), or from 0.00254 cm (0.001 inch) to 0.00508 cm (0.002 inches), or in some cases may be about 0.00381 cm (0.0015 inches). Thus, similar to the axial channel 145, the height H of each axially extending tooth 224 may range from about 0.000254 cm (0.0001 inch) to 0.00508 cm (0.002 inches), more typically from about 0.00127 cm (0.0005 inch) to 0.00495 cm (0.00195 inches), or from 0.00254 cm (0.001 inch) to 0.00508 cm (0.002 inches), or in some cases may be about 0.00381 cm (0.0015 inches). Although specific ranges are recited, all ranges from the smallest of the lower limits to the largest of the upper limits are included, and it is to be understood that this includes all intermediate ranges or specific dimensions within this entire range or any specifically recited range.

[0052] The foregoing description is provided to enable one skilled in the art to practice the various aspects described herein. While the foregoing is considered the best mode and / or describes other examples, it will be apparent to those skilled in the art that various modifications can be made to these aspects, and that the general principles defined herein can be applied to other aspects as well. Accordingly, the claims are not intended to be limited to the aspects shown herein, but are to be accorded the full scope consistent with the language claims, where reference to a singular element is not intended to mean "one and only one" unless specifically stated otherwise, but rather "one or more." Unless specifically stated otherwise, the terms "set" and "some" mean one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter (e.g., her and its), and vice versa. Headings and subheadings, if any, are used only for convenience and do not limit the present invention.

[0053] It should be understood that the specific order or sequence of steps of the disclosed process is an illustration of an exemplary approach. It should be understood that based on design preferences, the specific order and sequence of steps of the process can be reconfigured. Some of the steps may be performed simultaneously. The appended method claims present the elements of the various steps in exemplary order and are not intended to be limited to the specific order or sequence presented.

[0054] Terms such as "top," "bottom," "front," and "rear" as used in this disclosure should be understood to mean any coordinate system, not the ordinary gravitational coordinate system. Accordingly, the top surface, bottom surface, front surface, and rear surface may extend upwardly, downwardly, diagonally, or horizontally in the gravitational coordinate plane.

[0055] Phrases such as "aspect" do not implicitly mean that these aspects are essential to the technology of the subject matter, nor do they implicitly mean that these aspects apply to all configurations of the technology of the subject matter. The disclosure related to an aspect may apply to all configurations or one or more configurations. Phrases such as "an aspect" can mean one or more aspects, and vice versa. Phrases such as "embodiment" do not implicitly mean that these embodiments are essential to the technology of the subject matter, nor do they implicitly mean that these aspects apply to all configurations of the technology of the subject matter. The disclosure related to an embodiment may apply to all embodiments or one or more embodiments. Phrases such as "an embodiment" can mean one or more embodiments, and vice versa.

[0056] The word "exemplary" is used herein to mean "serving as an example or illustration". Any aspect or design described herein as "exemplary" is not necessarily construed as being a preferred or advantageous one over other aspects or designs.

[0057] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known to those of ordinary skill in the art or will be known to those of ordinary skill in the art in the future are hereby expressly incorporated by reference into this specification and are intended to be encompassed by the claims. Further, nothing disclosed herein is intended to be publicly available, whether or not it is expressly recited in the claims. No claim element is to be construed under the provisions of paragraph 6 of 35 U.S.C. § 112 unless expressly recited using the phrase "means for" or, in the case of a method claim, the phrase "step for." Further, to the extent the terms "include" or "have" are used in the description of this specification or the claims, these terms are intended to be as inclusive as the term "comprise" when construed as the traditional word in the claims.

Claims

1. A connector, a body having a tube port and a luer port; an internal bore extending axially between said tube port and said Luer port; a plurality of axial splines extending linearly along a first portion of the internal bore, a second portion of the internal bore being disposed between the first portion of the internal bore and the Luer port; a plurality of axial channels disposed between the plurality of axial splines; having the depth of each axial channel tapers in a direction toward said tube port; and The connector, wherein edges of the plurality of axial splines are configured to engage and grip an exterior surface of a tube, thereby retaining the tube within the body.

2. The connector of claim 1 , wherein each axial channel has a recess extending axially along the first portion of the internal bore.

3. 3. The connector of claim 2, wherein each recess has a depth within the range of approximately 0.0001 inch to 0.002 inch.

4. 2. The connector of claim 1, wherein the height of each axial spline is within the range of approximately 0.0001 inch to 0.002 inch.

5. 2. The connector of claim 1, wherein the angle between sides of adjacent axial splines is within the range of approximately 30 degrees to 150 degrees.

6. The connector of claim 1 , wherein the tubing comprises a microbore tubing.

7. The connector of claim 1 , wherein the plurality of axial splines are evenly spaced from one another around the first portion of the internal bore.

8. The connector of claim 1 , further comprising a tube portion, said tube portion comprising said first portion of said internal bore.

9. 9. The connector of claim 8, wherein the length of each axial spline spans less than half the length of the tube portion.

10. 2. The connector of claim 1, wherein the height of each axial spline tapers in a direction toward the tube port.

11. 2. The connector of claim 1, wherein the plurality of axial channels are configured to contain a solvent therein, the solvent configured to bond the exterior surface of the tube to the first portion of the interior bore.

12. 2. The connector of claim 1, wherein the body further includes a restriction in the internal bore disposed at an end of the first portion of the internal bore furthest from the tube port, the restriction protruding radially inward from an inner surface of the first portion of the internal bore.

13. 13. The connector of claim 12, wherein the restriction has a radial protrusion that protrudes radially inward at an angle from the inner surface of the first portion, the radial protrusion configured to form a seal between the restriction and the tube.

14. 1. A method of manufacturing a connector, comprising: providing a first core pin and a second core pin, the first core pin having a first core pin body having a luer mold portion and a restriction mold portion connected to each other, the second core pin having a second core pin body having a base portion and a tube mold portion connected to each other, a plurality of axially extending teeth and axially extending recesses formed along a radially outer portion of the tube mold portion; inserting the first core pin into a first portion of malleable material forming a luer portion of the connector and the second core pin into a second portion of malleable material forming a tube portion of the connector, the first and second core pins being axially aligned and inserted into the malleable material from opposite ends; contacting the axially extending teeth and the axially extending recesses with the malleable material forming the tube portion of the connector, thereby defining a plurality of axial splines and a plurality of recesses within an internal bore of the connector; The method includes:

Images