Connector and method of manufacturing a connector

Abstract

A connector and a method of manufacturing a connector are disclosed, the connector comprising: a body having a tubing port and a luer port; an internal bore extending axially between the tubing port and the luer port; a plurality of axial keys extending linearly along a first portion of the internal bore; and a plurality of axial channels disposed between the plurality of axial keys, wherein a depth of each axial channel gradually decreases in a direction towards the tubing port, and wherein edges of the plurality of axial keys are configured to engage and clamp an outer surface of a tubing to retain the tubing in the body.

Description

[0001] This application is a divisional of application No. 202080042032.1 (International Application No. PCT / US2020 / 025279) filed on March 27, 2020, having the title “Luer with Microporous Tubing Retention Pouch Incorporated with Axial Ridges”. TECHNICAL FIELD

[0002] The present disclosure relates generally to medical connectors, and more particularly to a medical connector having a retention mechanism for preventing a tubing piece coupled thereto from disengaging or separating from the connector due to a reduction in fluid in the tubing piece, and a sealing mechanism for preventing unintended leakage of fluid between the tubing piece and the connector. BACKGROUND

[0003] In the medical field, fluids are often administered as infusions. Containers holding medical fluids, such as flexible intravenous (IV) bags, are connected to infusion devices, such as IV needles, through disposable IV sets that contain tubing pieces having one or more hubs or connectors. The IV sets can also have intermediate ports or connection points where additional fluid containers can be connected to introduce or withdraw fluids. The tubing pieces are connected to the hubs or connectors through one or more forms of mechanical attachment and incorporation into the interior of the tubing piece, such as solvent welding between the inner bag of the hub and the outer surface of the tubing piece.

[0004] Medical connectors are widely used in fluid delivery systems, such as those associated with intravenous (IV) fluid lines, blood access, hemodialysis, peritoneal dialysis, enteral feeding, drug vial access, and the like. Medical connectors generally can connect two fluid lines or tubing pieces. SUMMARY

[0005] A medical connector can be a hollow tubular structure that receives a fluid line or tubing piece at one end thereof. The connector provides a flow path for fluid entering from the tubing piece to exit the connector from its opposite end. The presence of fluid in the tubing piece can create an airtight seal between the outer surface of the tubing piece and the inner surface of the medical connector. This seal can prevent the tubing piece from separating from the medical connector. However, when there is no fluid in the tubing piece or when the amount of fluid in the tubing piece is reduced, the seal can be weakened, and the tubing piece can easily separate from the connector, creating a “free-flow” leak.

[0006] Furthermore, in the case of using microporous tubing pieces, the minimal surface area of the microporous tubing piece used for incorporation presents an additional challenge to retaining the microporous tubing piece in the connector.

[0007] According to various embodiments of the present disclosure, a connector includes a body having a tubing portion, a luer portion axially opposite and connected with the tubing portion, and an inner circumferential surface defining an inner bore of the connector. The inner circumferential surface extends axially between the tubing portion and the luer portion, and the inner bore is in fluid communication with the tubing portion and the luer portion. The inner circumferential surface includes a plurality of keys 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 outer surface of a tubing in a coupled configuration. In the coupled configuration, edges of the keys pinch and engage the outer surface of the tubing to retain the tubing in the body.

[0008] According to various embodiments of the present disclosure, a connector includes a body having a tubing profile, a luer profile axially opposite and connected with the tubing portion, a restriction between the luer profile and the tubing profile, and an inner circumferential surface defining an inner bore at least in the tubing profile. The restriction includes a first end along the luer profile, a second end along the tubing profile, and a protrusion extending axially from the second end, and the protrusion extends into the inner bore. The inner circumferential surface is configured to engage an outer surface of a tubing in a coupled configuration. In the coupled configuration, the protrusion pinches the tubing to form a seal between the second end of the restriction and the tubing. BRIEF DESCRIPTION OF DRAWINGS

[0009] The following drawings are included to illustrate certain aspects of the embodiments, and should not be viewed by themselves as limiting the disclosed subject matter. The disclosed subject matter is capable of substantial modification in form and function, as will be readily apparent to those skilled in the art and others familiar with this disclosure.

[0010] Figure 1 A perspective view of an IV set having medical connectors that can employ the principles of the present disclosure is depicted in accordance with some embodiments of the present disclosure.

[0011] Figure 2 is a cross-sectional view of a medical connector of Figure 1 in accordance with some embodiments of the present disclosure.

[0012] Figure 3 is an enlarged partial view of an axial key and channel of a tubing section of a connector of Figure 2 in accordance with some embodiments of the present disclosure.

[0013] Figure 4 is an enlarged partial view of an axial key and channel of a tubing section of a connector of Figure 2 in accordance with some embodiments of the present disclosure.

[0014] Figure 5 is a cross-sectional view of a connector of Figure 2 in accordance with some embodiments of the present disclosure, including a tubing inserted therein.

[0015] Figure 6 According to some embodiments of the present disclosure is shown a connector for use in Figure 2 a core pin to form a tubing profile and a luer profile on an inner circumferential surface of the connector.

[0016] Figure 7 is a cross-sectional view of a connector according to some embodiments of the present disclosure, including a core pin disposed therein. Figure 2 Figure 6

[0017] Figure 8 is a cross-sectional view of a connector according to some embodiments of the present disclosure, including a core pin disposed therein. Figure 7 DETAILED DESCRIPTION

[0018] Various embodiments of the present disclosure are directed to providing a connector for an IV set with greater tubing retention using a microbore tubing with minimal surface area for bonding.

[0019] Various embodiments of the present disclosure are also directed to providing a connector with improved sealing capabilities to prevent unintended leakage of fluid between the outer surface of the tubing (e.g., microbore tubing) and the inner surface of the connector.

[0020] The disclosed embodiments are directed to a connector having a retention mechanism for preventing a microbore tubing coupled thereto from being decoupled and / or separated from the connector in the absence of fluid (or reduced fluid) in the tubing. The embodiments disclosed herein are further directed to a connector having a restriction mechanism for retaining the tubing in the connector and sealing between the tubing and the inner surface of the connector. As disclosed herein, the retention mechanism can include a plurality of keys extending axially along the inner circumference of the tubing portion of the connector. When a fluid line (tubing) is inserted into the tubing portion, the edges of the axial keys can drill into the tubing and grip the tubing for greater tubing retention within the tubing portion of the connector. For example, the fluid line can 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 strong pulling force needs to be exerted on the tubing to separate or decouple the tubing from the connector. As a result, unintended separation of the tubing can be minimized.

[0021] ​​​It is further advantageous that the adjacent keys define respective recesses or channels therebetween that similarly extend axially along the inner circumference of the tubing portion of the connector. Thus, an increased amount of solvent used to bond the fluid line or tubing to the tubing portion can be collected into the channels for maximum bonding. This will ensure even spreading of the solvent and eliminate the possibility of fluid scratching on the bonding surface. This is in contrast to conventional connector and fluid line bonding techniques where solvent flows into the connector and is subject to scratching by the tubing once the tubing is inserted into the connector, thereby reducing the surface area of the solvent between the tubing and the connector for bonding.

[0022] As disclosed herein, the restraining mechanism can include radial protrusions, a sealing ring, or a barb, barbed edge, or similar structure that can retain the tubing. Because of the interference fit between the tubing and the connector, the restraining mechanism ensures that a seal is maintained between the inner surfaces of the tubing and the connector during low pressure conditions (e.g., during a lack of fluid in the tubing). Thus, a relatively strong pulling force needs to be exerted on the tubing to separate or disengage the tubing from the connector. Thus, accidental disengagement of the tubing is minimized.

[0023] In some embodiments, the restraining mechanism can include one or more radial protrusions or lugs on the inner surface of the connector that limit the extension of the tubing in the connector when inserted therein. As described below, the connector can include a female luer at an end opposite the end that receives the tubing. The restraining mechanism prevents the tubing from extending into the female luer during assembly, thereby ensuring proper operation of the medical connector.

[0024] According to the disclosed embodiments, another advantage of the medical connector is that the manufacturing cost of the medical connector is not significantly increased. Existing manufacturing equipment can be modified at minimal cost to manufacture the example medical connector. For example, the core pin of the injection molding equipment used to manufacture the medical connector can be redesigned to form the axial keys and channels as well as the restraining mechanism.

[0025] As used herein, the terms “tubing,” “fluid line,” and any variations thereof refer to a medical line or tube used to deliver a liquid, solvent, or fluid (including gas) to or from a patient receiving medical care. For example, the fluid line (tubing) can be used for intravenous (IV) delivery of fluids, fluid drainage, oxygen delivery, combinations thereof, and the like.

[0026] As used herein, the terms "medical connector," "connector," "fitting," and any variations thereof refer to any device for providing a fluid flow path between two or more fluid lines coupled thereto. For example, a medical connector can be or can include a spike or other type of connector.

[0027] Figure 1 A perspective view of an IV set 10 having a medical connector 100 that can employ principles of the present disclosure is depicted in accordance with some embodiments of the present disclosure. As shown, the IV set can include a fluid source, such as a fluid bag 2, that can include or contain a saline solution or other fluid to be administered to a patient. As shown, a first tubing 6 carries flow from a drip chamber 4, through the connector 100, and into a second fluid line or tubing 170. An IV pump (not shown) receives fluid from the fluid system 2 via the second tubing 170 and controls and dispenses fluid therefrom to a patient. As will be described in further detail below, the tubular portion of the connector 100 has an internal bore configured to receive the second tubing 170. For purposes of the present disclosure, the second tubing 170 will be described as a micropore or small bore tubing, and the connector 100 will thus be described as being configured to receive and retain micropore tubing. However, various embodiments of the connector described herein can apply to other types of tubing, such as macropore or large bore tubing.

[0028] Figure 2 A cross-sectional view of a medical connector 100 of Figure 1 is shown in accordance with disclosed embodiments. As shown, the medical connector 100 (or simply, the connector) can include a generally cylindrical body 101 having a "first" or tubing portion 103 and a "second" or luer portion 105 that is axially opposite and connected to the tubing portion 103. In some embodiments, the body 101 can also include a handle 107 disposed along an outer surface of the body 101. The tubing portion 103 can include a tubing port 120 that can be sized and shaped to receive a fluid line (hereinafter, "tubing"), as described below. Similarly, the luer portion 105 can include a luer port 125 that can be sized and shaped to receive a male luer connector. As shown, the body 101 defines an internal longitudinal passageway or bore 140 that extends from the tubing port 120 to the luer port 125 and fluidly connects the tubing port 120 and the luer port 125 to one another.

[0029] In the depicted embodiment, the inner bore 140 is defined by the inner circumferential surface 112 of the main body 101 and is continuous from the tubing port 120 to the luer port 125. In some embodiments, the inner circumferential surface 112 in the tubing portion 103 and the luer portion 105 have two dissimilar profiles. Specifically, the inner circumferential surface 112 in the tubing portion 103 has a tubing profile 135 and the inner circumferential surface 115 in the luer portion 105 has a luer profile 133. The tubing profile 135 of the connector 100 and, in turn, the tubing portion 103, are sized and shaped (or otherwise configured) to receive a tubing. Specifically, the tubing profile 135 can be sized, shaped, and otherwise configured to receive a microbore tubing 170 (described in further detail below). For example, tubing having an inner diameter of less than 0.100 inches, and particularly tubing having an outer diameter of about 0.079 inches or less, is considered to be a "small bore" or "microbore" and is incorporated into a tubing pocket, such as the inner bore 140 defined in the tubing profile 135. Tubing having an inner diameter of greater than 0.100 inches is generally considered to be a "macrobore." The exemplary embodiments of the present disclosure are illustrated and described herein in relation to tubing in the form of "small bore" tubing or "microbore" tubing and pockets for "small bore" tubing or "microbore" tubing. However, the various embodiments of the present disclosure are not limited to the above-described configurations and can be similarly applied to "macrobore" tubing or "large bore" tubing and related connectors, as well as any other intermediate size tubing and connectors between "microbore" and "macrobore" connectors. The luer profile 133 of the connector 100 and, in turn, the luer portion 105, can be sized and shaped (or otherwise configured) to receive a male luer fitting. The luer profile 133 and, in turn, the luer portion 105, can conform to ISO-594.

[0030] During assembly, to limit the extent of tubing inserted, advanced, or otherwise "slid" into the connector 100, the inner circumferential surface 112 can include a limiting mechanism (hereinafter "limit 130"). The limit 130 can be defined as projecting radially inward from the inner circumferential surface 112 and can be interposed between the luer profile 133 and the tubing profile 135. In some embodiments, the limit 130 functions as a stop for tubing inserted into the inner bore 140 defined in the luer profile 133. Accordingly, the limit 130 can have a diameter D2 (as shown) that is less than the minimum diameter Dl of the inner bore 140 defined in the tubing profile 135. Figure 6

[0031] ​According to some embodiments, the tubing profile 135 of the tubing portion 103 can include a retention mechanism for improving the ability of the connector 100 to retain the microbore tubing 170 inserted therein, thereby preventing the microbore tubing 170 from separating (or otherwise disengaging) from the connector 100. For example, the retention mechanism can prevent the microbore tubing 170 from separating (or otherwise disengaging) from the connector 100 during periods of low pressure conditions in the tubing due to a reduction in fluid in the tubing. In an example, and as shown, the retention mechanism can be or can include a plurality of keys 115 extending linearly along the length of the inner circumferential surface 112 of the tubing portion 103 of the connector 100. When the microbore tubing 170 (as shown) is inserted into the tubing portion 103 of the connector 100, the inner circumferential surface 112 in the tubing portion 103 is configured to engage the outer surface of the microbore tubing 170 in the coupled configuration. For example, when the microbore tubing 170 is inserted into the tubing portion 103, the edges 137 of the axial keys 115 can dig into and grip the outer surface of the tubing for better tubing retention within the tubing portion of the connector. Thus, in the coupled configuration, the microbore tubing 170 can be inserted into the tubing portion in an interference fit such that the edges 137 of the axial keys 115 dig into, grip, and engage the outer surface of the microbore tubing 170 to retain the microbore tubing 170 in the tubing portion 103 of the connector 100. The above-described configuration provides the advantage that once the edges 137 of the axial keys 115 dig into, grip, and engage the outer surface of the microbore tubing 170, the friction between the microbore tubing 170 and the inner circumferential surface 112 increases such that the microbore tubing 170 can not easily disengage from the connector 100 without departing from the scope of the present disclosure. For example, by biting into or digging into the outer surface of the microbore tubing 170, the axial keys can increase the friction between the connector 100 and the microbore tubing 170 when a pulling force (as indicated by arrow F) is exerted on the microbore tubing 170 to remove it from the connector 100. Thus, advantageously, the pulling force required to remove the microbore tubing 170 from the connector 100 or otherwise disengage the microbore tubing 170 is increased and, therefore, the microbore tubing 170 is better secured and retained in the connector 100. Furthermore, the fluid in the microbore tubing 170 can exert a pressure in a radially outward direction which can further increase the friction between the microbore tubing 170 and the inner circumferential surface 112. Figure 5 Figure 5

[0032] ​​According to some embodiments, adjacent keys 115 define respective recesses or channels 145 therebetween. Channels 145 similarly extend axially along the inner circumferential surface 112 of the fitting portion 103 of the connector 100. Advantageously, an increased amount of solvent used to bond the microbore fitting 170 to the inner circumferential surface 115 defined in the fitting portion 103 can be collected into the channels 145 for maximum bonding. In particular, collecting solvent in the channels 145 allows an increased amount of solvent to be available for bonding the microbore fitting 170 to the inner circumferential surface 115 of the fitting portion 103. Providing the channels 145 with solvent collected therein will result in uniform solvent diffusion and eliminate fluid wiping that can occur on the bonding surface of the fitting portion 103. Thus, a maximum amount of solvent remains available for bonding the microbore fitting 170 to the inner circumferential surface 115 of the fitting portion 103 and even better fitting retention can be achieved. This is in contrast to conventional connector and fitting bonding techniques in which solvent flows into the connector and is subject to wiping by the fitting once the fluid line / fitting is inserted into the connector, thereby reducing the surface area of solvent between the fitting and the connector.

[0033] Figure 3 is a partial cross-sectional view of an axial key and channel of a fitting portion of a connector according to some embodiments of the present disclosure. Figure 2 is a partial cross-sectional view of an axial key and channel of a fitting portion of a connector according to some embodiments of the present disclosure. Figure 4 is a partial cross-sectional view of an axial key and channel of a fitting portion of a connector according to some embodiments of the present disclosure. Figure 2 is a partial cross-sectional view of an axial key and channel of a fitting portion of a connector according to some embodiments of the present disclosure.

[0034] Referring to Figure 3 and Figure 4 , and continuing to refer to Figure 2 , each axial key can be defined by a first angled surface 117, a second angled surface 119, and an edge 137 between the first and second angled surfaces 117 and 119. As shown, the axial keys can be formed in the shape of teeth of a spline gear. Since the channels 145 are defined between adjacent keys 115, each channel 145 is defined by adjacent first and second angled surfaces 117 and 119 that meet at an apex 121. However, the shape of the axial keys 115 and channels 145 are not limited to the above-described configuration. For example, the axial keys 115 and channels 145 can not be limited to any particular shape or size, so long as the axial keys 115 have a shape that "bites into," "drills into," clamps, or otherwise engages the outer surface of the microbore fitting 170, and so long as the channels 145 form a recess of sufficient depth to contain solvent therein.

[0035] According to some embodiments, the axial keys 115 and channels 145 can be disposed at regular intervals along the inner circumferential surface 112 of the tube portion 103. However, in other embodiments, the axial keys 115 and channels 145 can be disposed at irregular intervals along the inner circumferential surface 112 of the tube profile 135.

[0036] According to some embodiments, the angle a between the first angled side 117 and the second angled side 119 of adjacent keys ranges from about 30 degrees to 150 degrees, more typically about 60 degrees to 120 degrees, 80 degrees to 100 degrees, or in some cases approximately 90 degrees. Although recited in terms of certain ranges, it should be understood that all ranges from the lowest value of the lower limit to the highest value of the upper limit are included, including all intermediate ranges or specific angles within that complete range or any specifically recited range.

[0037] In some embodiments, the height of each key, measured from the apex 121 to the edge 137 of each key, can range from about 0.0001 inch to 0.002 inch, more typically about 0.0005 inch to 0.00195 inch, 0.001 inch to 0.002 inch, or in some cases approximately 0.0015 inch. Thus, the depth of each of the channels 145 defined by adjacent keys 115 can range from about 0.0001 inch to 0.002 inch, more typically about 0.0005 inch to 0.00195 inch, 0.001 inch to 0.002 inch, or in some cases approximately 0.0015 inch. Although recited in terms of certain ranges, it should be understood that all ranges from the lowest value of the lower limit to the highest value of the upper limit are included, including all intermediate ranges or specific dimensions within that complete range or any specifically recited range.

[0038] In some embodiments, the depth of each of the channels gradually decreases in a direction toward the tube port 120. For example, each channel 145 can have a maximum depth in a region proximate the second end 155 of the restriction 130. As the channel 145 approaches the tube port 120, the depth of each channel 145 can gradually decrease until each channel 145 terminates.

[0039] Referring back to Figure 2Each of the axial keys 115 spans a portion of the length of the inner circumferential surface 112 of the fitting portion 103. In some embodiments, the length of the axial key 115 spans between approximately 10% and 90% of the length of the inner circumferential surface 112 of the fitting portion 103, more typically between approximately 25% and 75%, between approximately 40% and 60%, or in some cases approximately 50% of the length of the inner circumferential surface 112 of the fitting portion 103. Since channels 145 are defined between adjacent axial keys 115, the length of each channel 145 can similarly span between approximately 10% and 90% of the length of the inner circumferential surface 112 of the fitting portion 103, more typically between approximately 25% and 75%, between approximately 40% and 60%, or in some cases approximately 50% of the length of the inner circumferential surface 112 of the fitting portion 103. Although described in terms of certain ranges, it should be understood that all ranges from the lowest value of the lower limit to the highest value of the upper limit are included, including all intermediate ranges or specific percentages within that full range or any specific described range. To prevent accidental fluid leakage, and to prevent accidental leakage of solvent from fitting section 103, it is advantageous to ensure that the passage does not extend continuously through the fitting port.

[0040] Figure 5 According to some embodiments of this disclosure Figure 2 A cross-sectional view of connector 100, including a micro-perforated tube 170 inserted therein. As previously described, connector 100 may include a restraint 130. Figure 5 As shown, the limiting member 130 may include a first end 150 defined along a Luer profile 133 and a second end 155 defined along a tubular profile 135. In the depicted embodiment, the second end 155 may include a radial protrusion 160 that projects radially inward (or otherwise) from the inner circumferential surface 112 of the tubular profile 135 and at an angle to the inner circumferential surface 112 of the tubular profile 135. The radial protrusion 160 may be configured to drill into, clamp, or otherwise engage the first end of the microporous tubular fitting 170 to form a seal between the second surface 155 of the limiting member 130 and the microporous tubular fitting 170, thereby preventing accidental leakage of fluid between the outer surface 172 of the microporous tubular fitting 170 and the inner circumferential surface 112 defined in the tubular portion 103. In some embodiments, the radial protrusion 160 is circularly arranged about the central axis X1 of the inner bore 140.

[0041] The radial protrusion 160 may form a sealing ring that prevents accidental leakage of fluid between the outer surface of the microporous fitting 170 and the inner circumferential surface 112 defined in the fitting portion 103. In some embodiments, the radial protrusion 160 may be undercut to fully "engage" or otherwise engage the first end of the microporous fitting 170.

[0042] In some embodiments, the radial protrusion 160 protrudes into the internal bore 140 a maximum distance that is less than or equal to the thickness of the microporous tubing 170. This prevents the radial protrusion 160 from obstructing fluid flow through tubing inserted into the connector 100. The restriction 130 can not be limited to any particular shape or size, so long as it prevents the extension of tubing inserted into the connector 100.

[0043] Accordingly, in some embodiments, the radial protrusion 160 can also act as a retention mechanism to improve the ability of the connector 100 to retain the microporous tubing 170 inserted therein, thereby preventing the microporous tubing 170 from becoming detached (or otherwise disengaged) from the connector 100, for example, during periods of low pressure conditions in the tubing due to a reduction in fluid in the tubing. In examples, the radial protrusion 160 can be disposed at or near the boundary between the tubing portion and the luer portion 105, as shown. The radial protrusion 160 can protrude radially inwardly from the inner circumferential surface 112 a distance into the internal bore 140 defined in the tubing portion 103, as shown. In examples, the radial protrusion 160 can be a spike-like structure extending from the inner circumferential surface 112.

[0044] Advantageously, the radial protrusion 160 can thus be a structure that increases the friction between the outer surface of the microporous tubing 170 and the inner circumferential surface 112, such that the microporous tubing 170 can not be easily disengaged from the connector 100 without departing from the scope of the present disclosure. In some embodiments, the radial protrusion 160 can be configured as a ramp with a slight undercut configured to slightly press against the microporous tubing 170 as it is inserted or advanced into the connector 100. When the microporous tubing 170 is pulled to be withdrawn from the connector, the top of the ramp, and in some embodiments the undercut portion, will secure the microporous tubing 170 within the connector 100, as shown. In some embodiments, the top of the ramp or the undercut portion will dig into or grip the microporous tubing when attempting to withdraw the microporous tubing 170 from within the connector 100, as explained further below. Figure 5

[0045] With reference to Figure 5 , continuing with reference to Figure 2 ​With the micro-porous tubing 170 inserted into the connector 100, the radial protrusion 160 can increase the friction between the connector 100 and the micro-porous tubing 170. Thus, the force required to remove or otherwise disengage the micro-porous tubing 170 from the connector 100 is increased, and thus the micro-porous tubing 170 is better secured in the connector 100. Additionally, fluid in the micro-porous tubing 170 can exert pressure in a radially outward direction, which can further increase the friction between the micro-porous tubing 170 and the radial protrusion 160.

[0046] It should be noted that the location of the radial protrusion on the inner circumferential surface 112 in the figures is merely an example, and that the location can be varied without departing from the scope of the present disclosure. Additionally, although the figures indicate one radial protrusion, the radial protrusion can be replaced, for example, with lugs and / or barb features, the number of which can be unlimited, and can be increased or decreased without departing from the scope of the present disclosure. For example, a plurality of lugs can be disposed at regular intervals along the inner circumferential surface 112 in the tubing portion 103. However, in other embodiments, the lugs can be disposed at irregular intervals along the inner circumferential surface 112. Similarly, a plurality of barb features can be disposed at regular intervals along the inner circumferential surface 112 in the tubing portion 103. However, in other embodiments, the barb features can be disposed at irregular intervals. The circumferential extent of the barb features can be around a quadrant of the inner circumferential surface 112. However, in other examples, the circumferential extent of the barb features can be increased or decreased as needed for the application or design, and without departing from the scope of the present disclosure.

[0047] Figure 6 According to some embodiments of the present disclosure, a connector 100 for use in a system 10 for Figure 2 The core pins 201 and 203 form the tubing profile 135 and the luer profile 133, respectively, on the inner circumferential surface 112 of the connector 100. According to some embodiments, the connector 100 can be manufactured using an injection molding process. However, other manufacturing processes can be used to manufacture the connector 100 without departing from the scope of the present disclosure. 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 tubing profile 135 of the inner circumferential surface 112. Process steps and molds for forming features on the outer surface of the body 101 (e.g., the handle 107) are omitted for brevity.

[0048] As shown, the core pin 201 has a generally elongated body 202 having a luer-forming portion 206 and a restriction-forming portion 208. The luer-forming portion 206 has a generally cylindrical outer surface 212 having a diameter that is greater than the diameter of the restriction-forming portion 208. The outer surface 212 of the luer-forming portion 206 is shaped to form the luer profile 133 (as shown) of the luer portion 102. Figure 2 A restriction-forming profile 210 can be formed on the outer surface 212 proximate the distal end 218 of the luer-forming portion 206.

[0049] According to some embodiments, the core pin 203 also has a generally elongated body 222 having a base portion 225 with a cylindrical outer surface 226 and a tube-forming portion 220 with a cylindrical outer surface 222. In some embodiments, the diameter D4 of the base portion 225 is greater than the diameter D3 of the tube-forming portion 220. The cylindrical outer surface 222 is shaped and sized to form the tube profile 135 (as shown) of the tube portion 103. Figure 2 In the depicted embodiment, the cylindrical outer surface 222 of the tube-forming portion 220 can be formed with 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 described below, during manufacture, the teeth 224 define the shape of the channel 145 and the recesses 215 define the shape of the axial key 115 of the connector.

[0050] In the depicted embodiment, the length of each axially-extending tooth 224 can span 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 teeth 224 spans between about 10% and 90%, more typically between about 25% and 75%, between about 40% and 60%, or in some cases approximately 50% of the length of the inner circumferential surface 112 of the tube portion 103. Since recesses 215 are defined between adjacent axially-extending teeth 224, the length of each of the recesses can similarly span between about 10% and 90%, more typically between about 25% and 75%, between about 40% and 60%, or in some cases approximately 50% of the length of the inner circumferential surface 112 of the tube portion 103. Although recited in terms of certain ranges, it should be understood that all ranges from the lowest of the lower bounds to the highest of the upper bounds are included, including all intermediate ranges or specific percentages within that complete range or any specifically recited range.

[0051] Figure 7 is a connector according to some embodiments of the present disclosureFigure 2 A cross-sectional view of the connector (shown in dashed lines), including the components disposed therein. Figure 6 The core pins are 201 and 203. Figure 8 It is according to some embodiments of this disclosure along Figure 7 The image shows a cross-sectional view of connector 100 and core pin 203 taken from line 8-8. According to some embodiments, connector 100 can be manufactured using an injection molding process. Connector 100 can be made of plastic or a similar material that can be molded into the desired shape. An external mold (not shown) can be used to form the external features of connector 100. These external features may include a handle 107 and the outer surface of a cylindrical body 101. The inner bore 140, tubular profile 135, Luer profile 133, restraint 130, and radial protrusion 160 can be formed using core pins 201 and 203.

[0052] During manufacturing, material forming connector 100 can be placed in a molding tool including core pins 201 and 203 axially aligned with each other. Core pins 201 and 203 can be brought together from their axially opposite ends into the material. The material can be in a semi-solid, malleable state to allow it to be molded into the desired shape. Core pins 201 and 203 can be brought closer together until they are engaged, as shown below. Figure 7 As shown.

[0053] Back to reference Figure 6 The distal end 219 of the tubular forming portion 220 of the mandrel 203 may include a radially protruding forming profile 228, which includes a ring having an inner surface 229 angled radially inward and a cavity 230 defined therethrough. When the mandrels 201 and 203 are engaged with each other, the distal end 218 of the mandrel 201 is partially received into the cavity 230 defined by the radially protruding forming profile 228. Specifically, as shown, the distal end 218 of the mandrel 201 is concentrically disposed with the inner surface 229 of the radially protruding forming profile 228 and is radially located inside it. The retaining member forming portion 208 and the radially protruding forming profile 228 together form the retaining member 130 and the radial protrusion. Specifically, when the mandrels 201 and 203 are engaged with each other, a gap is formed between the retaining member forming portion 208 and the radially protruding forming profile 228. The gap is filled with a semi-solid, malleable connector material and molded into the shape of the gap (i.e., the shape of the radial protrusion 160).

[0054] Furthermore, during manufacturing, when the core pins 201 and 203 are coupled to one another, and the semi-solid, malleable connector material is placed in a molding tool that includes the core pins 201 and 203 axially aligned with one another, the axially extending teeth 224 can dig into the semi-solid, malleable connector material and form an impression therein. The semi-solid, malleable connector material can also fill the recesses 215 and be molded to the shape defined by the recesses 215. Once the semi-solid, malleable connector material solidifies, the core pins 201 and 203 are removed. When the core pin 203 is removed, an axially extending recess is formed along the inner circumferential surface 112 of the fitting portion 103 where the axially extending teeth 224 dug into the connector material. The axially extending channel corresponds to the axially extending channel 145 in the fitting profile 135 of the fitting portion 103. Similarly, when the core pin 203 is removed, axially extending keys protrude along the inner circumferential surface 112 of the fitting portion 103 where the semi-solid, malleable connector material filled the recesses 215. The filled recesses 215 correspond to the axial keys 115 formed on the fitting profile 135 of the fitting portion 103.

[0055] As previously described, in some embodiments, the depth of each channel 145 gradually decreases in a direction toward the fitting port 120. The gradual decrease in the depth of each channel 145 is due to the configuration of the fitting profile 135. For example, as shown, the diameter Dl of the inner bore 140 at the end of the fitting profile 135 proximate the restriction 130 is less than the diameter D2 of the inner bore 140 at the end of the fitting profile 135 proximate the fitting port 120. Thus, the fitting profile 135 tapers in a direction from the end proximate the fitting port 120 to the end proximate the restriction 130. When the core pin 203 having the axially extending teeth 224 is positioned in a mold with the material used to form the connector 100, the teeth 224 dig deeper into the connector material in the region of the fitting profile proximate the restriction 130 (due to the smaller diameter Dl) and gradually less in the direction of the fitting port 120 (due to the increase in diameter to D2 in the direction of the fitting port). As the teeth 224 dig deeper into the connector material in the region of the fitting profile 135 proximate the restriction 130, the resulting channels 145 have a greater depth and the resulting axial keys have a greater height in this region than in the region proximate the fitting port 120.

[0056] An advantage of the above-described configuration is that the axial keys 115 are able to grip or clamp the micro-porous fitting 170 to a greater extent in the region of the fitting profile proximate the restriction 130, thereby requiring a relatively stronger pulling force to be exerted on the micro-porous fitting 170 to separate or disengage the micro-porous fitting 170 from the connector 100. Thus, accidental separation of the micro-porous fitting 170 from the connector 100 can be minimized.

[0057] According to some embodiments, the axial keys 115 and channels 145 can be provided at regular intervals along the inner circumferential surface 112 of the tube portion 103. However, in other embodiments, the axial keys 115 and channels 145 can be provided at irregular intervals along the inner circumferential surface 112 of the tube profile 135.

[0058] According to some embodiments, the angle a between the first angled side 117 and the second angled side 119 of adjacent keys ranges from about 30 degrees to 150 degrees, more typically about 60 degrees to 120 degrees, and 80 degrees to 100 degrees, or in some cases approximately 90 degrees. Although recited according to certain ranges, it should be understood that all ranges from the lowest value of the lower limit to the highest value of the upper limit are included, including all intermediate ranges or specific angles within that complete range or any specifically recited range.

[0059] In some embodiments, similar to the axial keys 115, the depth of each recess 215 can range from about 0.0001 inch to 0.002 inch, more typically about 0.0005 inch to 0.00195 inch, 0.001 inch to 0.002 inch, or in some cases approximately 0.0015 inch. Thus, similar to the axial channels 145, the height H of each axially extending tooth 224 can range from about 0.0001 inch to 0.002 inch, more typically about 0.0005 inch to 0.00195 inch, 0.001 inch to 0.002 inch, or in some cases approximately 0.0015 inch. Although recited according to certain ranges, it should be understood that all ranges from the lowest value of the lower limit to the highest value of the upper limit are included, including all intermediate ranges or specific dimensions within that complete range or any specifically recited range.

[0060] The preceding description is provided to enable any person skilled in the art to practice the various aspects described herein. While the best mode has been described and / or claimed, it is understood that various modifications can be made within the scope of the present disclosure and the general principles set forth herein. Therefore, the disclosure is not intended to be limited to the aspects described 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 term “some” refers to one or more. Singular referents include plural referents unless specifically stated otherwise. Headings and subheadings, if any, are used for convenience and do not limit the application.

[0061] It is to be understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary processes. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes can be reordered. Some of the steps can be performed at the same time. 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.

[0062] Terms such as "top," "bottom," "front," "back," etc., as used in this disclosure, should be understood in reference to any frame of reference, and not in reference to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a back surface can extend upward, downward, diagonally, or horizontally in a gravitational frame of reference.

[0063] Phrases such as "aspect" do not indicate that a particular aspect is essential to the subject technology, or that the aspect applies across all constructions of the subject technology. Disclosure in relation to one aspect can apply to all constructions, or one or more constructions. Phrases such as "aspect" can refer to one or more aspects, and vice versa. Phrases such as "embodiment" do not indicate that a particular embodiment is essential to the subject technology, or that the embodiment applies across all constructions of the subject technology. Disclosure in relation to one embodiment can apply to all embodiments, or one or more embodiments. Phrases such as "embodiment" can refer to one or more embodiments, and vice versa.

[0064] The use of the word "example" herein is used as meaning "serving as an example or illustration." Any aspect or design described herein as "example" is not necessarily to be construed as preferred or advantageous over other aspects or designs.

[0065] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. 112(f) unless the element is expressly recited in the claim as "means plus function." Furthermore, to the extent that the term "include," "has," or the like is used in the detailed description and claims, such term is intended to be inclusive in a manner similar to the term "comprise" as "comprise" is interpreted when employed as a transitional word in a claim.

Claims

1. A connector comprising: a body having a tubing port and a luer port axially opposite and connected to the tubing port; an internal bore extending axially between the tubing port and luer port; a plurality of axial keys extending linearly along a first portion of the internal bore; a plurality of axial channels disposed between the plurality of axial keys; and a tubing portion, wherein the tubing portion comprises the first portion of the internal bore, and a second portion of the internal bore is disposed between the first portion of the internal bore and the tubing port, the second portion of the internal bore having no axial keys and axial channels, wherein a depth of each axial channel gradually decreases in a direction toward the tubing port, wherein edges of the plurality of axial keys are configured to engage and clamp an outer surface of a tubing to retain the tubing in the body, and wherein the first portion of the internal bore comprising the plurality of axial keys and plurality of axial channels is adjacent to a restriction portion of the internal bore for limiting an extent of a tubing inserted into the connector. Each axial channel comprises a recess extending axially along the first portion of the internal bore.

2. The connector of claim 1, wherein, Each recess has a depth between 0.0001 inch and 0.002 inch.

3. The connector of claim 2, wherein, Each axial key has a height between 0.0001 inch and 0.002 inch.

4. The connector of claim 1, wherein, An angle between side surfaces of adjacent axial keys is between 30 degrees and 150 degrees.

5. The connector of claim 1, wherein, The tubing comprises a microporous tubing.

6. The connector of claim 1, wherein, The plurality of axial keys are equally spaced apart from each other around the first portion of the internal bore.

7. The connector of claim 1, wherein, A length of each axial key spans half or less of a length of the tubing portion.

8. The connector of claim 1, wherein, A height of each axial key gradually decreases in a direction toward the tubing port.

9. The connector of claim 1, wherein, The channels are configured to contain a solvent therein, and wherein the solvent is configured to bind the outer surface of the tubing to the first portion of the internal bore.

10. The connector of claim 1, wherein, The restriction portion of the internal bore is disposed at an end of the first portion of the internal bore furthest from the tubing port, and the restriction portion extends radially inward beyond an inner surface of the first portion of the internal bore.

11. The connector of claim 1, wherein, The restriction portion comprises a radial protrusion extending at an acute angle from the inner surface of the first portion, the radial protrusion configured to form a seal between the restriction portion and the tubing.

12. The connector of claim 11, wherein, 13. A method of manufacturing the connector of claim 1, comprising: providing a first core pin comprising a first core pin body having a luer shaped portion and a restriction shaped portion connected to each other, and a second core pin comprising a second core pin body having a base portion and a tubing shaped portion connected to each other, wherein a plurality of axially extending teeth and axially extending recesses are formed along a radially outer portion of the tubing shaped portion; inserting the first core pin into a first portion of a malleable material forming a luer portion of the connector, and inserting the second core pin into a second portion of the malleable material forming a tubing portion of the connector, the first core pin and the second core pin axially aligned and inserted into the malleable material from opposite ends; and ​ contacting the axially extending teeth and axially extending recesses with ductile material forming a pipe fitting portion of the connector to define a plurality of axial keys and a plurality of recesses in an interior bore of the connector.

14. The method of claim 13, wherein, The first core pin further includes a restriction shaped portion at a distal end thereof, and the second core pin further includes a radial projection forming profile at a distal end thereof, the method further comprising: contacting distal ends of the first core pin and the second core pin such that the distal end of the first core pin is at least partially received in a cavity at the distal end of the second core pin, and the restriction shaped portion is in a space between the radial projection forming profile; and forming a radial projection in the space between the restriction shaped portion and the radial projection forming profile by filling the space with ductile material.

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