Shape memory polymer connector

Abstract

A connection assembly for connecting an intravenous (IV) device to tubing is provided. The connection assembly includes a component connector and a shape memory polymer (SMP) member formed from a shape-changing material. The connection assembly allows the tubing to move along the component connector when the SMP member is in an expanded state and holds the tubing securely against the component connector when the SMP member is in a contracted state. The shape-changing material changes to one of an expanded state and a contracted state upon receiving an external stimulus. A method for assembling the connection assembly is also provided.

Description

[Technical Field]

[0001] An infusion or intravenous (IV) set is assembled by connecting multiple translucent polymeric tubing segments to multiple polymeric components. [Background technology]

[0002] Joints are typically formed by applying a thin layer of solvent or adhesive to one or both of the contact surfaces and then mating the two surfaces. The tubing contact surface can be on either the inner diameter, the outer diameter, or both diameters from one end to a certain length. The solvent / adhesive is applied to either the inside, the outside, or both. The bond area is a critical parameter that, if not controlled, can cause the tubing / component connection to leak or separate easily. Joints may also be formed by tightening a retaining ring to compress the tubing segment onto the component connector. The retaining ring is typically crimped or crushed after placement onto the tubing / connector connection. The degree of retention force is also a critical parameter that can cause the tubing / component connection to leak or separate easily. Joint parameters and retention force can each vary significantly due to design imperfections, assembly process imperfections, and process drift.

[0003] Typical joining / retaining connections have several drawbacks, such as low pull-out force, which can cause the joining / retaining connection to separate, and low burst pressure, which can cause the joining / retaining connection to leak or rupture. Summary of the Invention [Problem to be solved by the invention]

[0004] It would be desirable to provide a stronger connection between the IV tubing and the IV components that increases the withdrawal force and burst pressure parameters, thereby minimizing leakage and separation. [Means for solving the problem]

[0005] The present disclosure provides a shape memory polymer (SMP) connector for IV components that is used to provide a strong, consistent connection between IV tubing and IV components when subjected to certain external stimuli such as temperature, thermal gradients, and moisture.

[0006] In one or more embodiments, a connection assembly for an IV component is provided. The connection assembly includes a component connector having a receptacle configured to slidably receive an inner surface of IV tubing to form a connector / tubing connection, and an SMP ring formed from a shape-changing material. The SMP ring has an expanded state in which the SMP ring is slidably positioned and surrounds the connector / tubing connection, and a contracted state in which the SMP ring is held in a retaining position and clamps the connector / tubing connection. The shape-changing material is configured to change to one of the expanded state and the contracted state upon receiving an external stimulus.

[0007] In one or more embodiments, the receptacle is sized and shaped to provide a friction fit with the inner surface of the IV tubing. In one or more embodiments, the receptacle includes a barb sized and shaped to provide a friction fit with the inner surface of the IV tubing. In one or more embodiments, the barb has an outer periphery, and the SMP ring has an inner diameter narrower than the outer periphery of the barb when the SMP ring is in a contracted state. In one or more embodiments, one of a solvent bond and an adhesive bond is disposed between the receptacle and the inner surface of the IV tubing. In one or more embodiments, the external stimulus is a temperature change. In one or more embodiments, the external stimulus is a moisture content change.

[0008] In one or more embodiments, the shape-changing material is configured to expand upon application of a solvent that acts as an assembly lubricant and contract upon application of a temperature change. In one or more embodiments, the shape-changing material is an extruded thermo-responsive material that maintains its expanded state outside of an extrusion water bath, and the cloud point of the thermo-responsive material is configured to cause the thermo-responsive material to shrink to a contracted state upon loss of moisture content when elevated temperatures are applied. In one or more embodiments, the shape-changing material includes poly(N-isopropylacrylamide) (PNIPAAm) blended with one of EVA, poly(ethylene glycol), TPU, TPE, or melt-processable polybutadiene. In one or more embodiments, the shape-changing material includes a flexible PVC blend containing one of PP, EVA, and LDPE. In one or more embodiments, the shape-changing material includes a flexible TPE blend containing one of PP, EVA, and LDPE.

[0009] In one or more embodiments, a connection assembly for an IV component is provided. The connection assembly includes an SMP connector formed from a shape-changing material. The SMP connector includes a shaft configured to slidably receive an inner surface of IV tubing, a compression flange configured to slidably receive an outer surface of IV tubing, the shaft, compression flange, and IV tubing forming a connector / tubing interface, and a gap between the shaft and the compression flange. In an expanded state, the compression flange is expanded, and the gap at the tubing insertion end of the SMP connector has a first width. In a contracted state, the compression flange is narrowed, and the gap at the tubing insertion end of the SMP connector has a second width that is narrower than the first width. The shape-changing material is configured to change to one of the expanded state and the contracted state upon receiving an external stimulus.

[0010] In one or more embodiments, the compression flange is expanded to an expanded state by a force applied by an expansion tool, and the compression flange is contracted to a contracted state by application of a temperature change to the compression flange. In one or more embodiments, the expanded state of the compression flange is funnel-shaped, and the contracted state of the compression flange is cylindrical. In one or more embodiments, a solvent bond and an adhesive bond are disposed between one of the shaft and the compression flange and the inner surface of the IV tubing. In one or more embodiments, the shape-changing material comprises PNIPAAm blended with one of EVA, poly(ethylene glycol), TPU, or melt-processible polybutadiene, and the cloud point of the shape-changing material is configured to cause the shape-changing material to shrink to the contracted state upon loss of moisture content when an elevated temperature is applied.

[0011] In one or more embodiments, an infusion set assembly is provided. The infusion set includes an IV set component, IV tubing, and a connection assembly that connects the IV tubing to the IV set component. The connection assembly includes a component connector configured to slidably receive an inner surface of the IV tubing and an SMP member formed from a shape-changing material. The connection assembly is configured to allow slidable movement of the IV tubing relative to the component connector when the SMP member is in an expanded state. The connection assembly is configured to securely hold the IV tubing to the component connector when the SMP member is in a contracted state. The shape-changing material is configured to change to one of an expanded state and a contracted state upon receiving an external stimulus.

[0012] In one or more embodiments, the component connector includes a receptacle having a barb, and the SMP member is a ring having a first diameter in an expanded state that surrounds the widest portion of the barb and is larger than the diameter of the IV tubing, and a second diameter in a contracted state that surrounds the widest portion of the barb and is smaller than the diameter of the IV tubing. In one or more embodiments, the component connector is a shaft that engages the inner surface of the IV tubing, and the SMP member is a compression flange that engages the outer surface of the IV tubing, and the SMP member has a flared shape in the expanded state, where a gap between the shaft and the compression flange has a first width at the tube insertion end of the gap and a second width at the base of the gap, the first width being larger than the second width, and a cylindrical shape in the contracted state, where the first width of the gap is the same as the second width of the gap.

[0013] Additional features and advantages of the present disclosure will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the present disclosure. The objectives and other advantages of the present disclosure will be realized and attained by the structure particularly pointed out in the description and claims set forth herein, as well as the appended drawings.

[0014] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the present disclosure as claimed.

[0015] The accompanying drawings, which are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate examples of the disclosure and, together with the description, serve to explain the principles of the disclosure. [Brief explanation of the drawings]

[0016] [Figure 1] 1 is a schematic diagram of a typical assembled infusion set. [Figure 2] FIG. 1 is a perspective view of an SMP connector component in a contracted state according to an embodiment of the present disclosure. [Figure 3]FIG. 3 is a perspective view of the SMP connector component of FIG. 2 in an expanded state according to an embodiment of the present disclosure. [Figure 4] FIG. 1 is a front view of an IV component / tubing connection according to an embodiment of the present disclosure. [Figure 5] FIG. 1 is a front view of an IV component / tubing connection assembly according to an embodiment of the present disclosure. [Figure 6] FIG. 6 is a front cross-sectional view of the IV component / tubing connection assembly of FIG. 5 according to an embodiment of the present disclosure. [Figure 7A] 1 is a partial cross-sectional front view of a component / tube connection having an adhesive joint according to an embodiment of the present disclosure. [Figure 7B] 1 is a partial cross-sectional front view of a component / tube connection having an adhesive joint according to an embodiment of the present disclosure. [Figure 8] FIG. 1 is a perspective view of an SMP connector component in a contracted state according to an embodiment of the present disclosure. [Figure 9] FIG. 9 is a perspective view of the SMP connector component of FIG. 8 engaged with a forming tool according to an embodiment of the present disclosure. [Figure 10] FIG. 9 is a perspective view of the SMP connector component of FIG. 8 in an expanded state according to an embodiment of the present disclosure. [Figure 11] FIG. 1 is a cross-sectional perspective view of an IV component / tubing connection in an expanded state according to an embodiment of the present disclosure. [Figure 12] FIG. 12 is a cross-sectional perspective view of the IV component / tubing connection of FIG. 11 in a contracted state, according to an embodiment of the present disclosure. [Figure 13] FIG. 1 is a schematic diagram of properties of an SMP material, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0017] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details to provide a thorough understanding of the subject technology. Accordingly, dimensions are provided with respect to particular embodiments as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0018] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology are disclosed herein according to specific, but non-limiting examples. The various embodiments described in this disclosure can be implemented in different ways and variations according to a desired application or implementation.

[0019] Infusion sets can be formed from any combination of infusion components and tubing. Typically, the infusion components and tubing are disposable products that are discarded after a single use. The infusion components and tubing can be formed from any suitable material (e.g., thermoplastics, thermoplastic elastomers, silicone, and rubber). A challenge in manufacturing an infusion set is consistently connecting the tubing and the infusion components to obtain a secure and / or leak-free connection with the desired fluid flow. The connection can be formed on either the inner or outer diameter of the tubing.

[0020] A typical connection between an IV component and IV tubing involves standard IV tubing connected to a rigid (e.g., plastic, metal) IV component connector via an adhesive / solvent joint or a crimped retainer ring. In the case of an adhesive joint, an imperfect connection between the IV component connector and the IV tubing leaves a gap. In the case of a retainer ring, a large force is required to crimp the retainer ring onto the IV component connector through the IV tubing. However, the pull-out force of a crimped connection is relatively low (e.g., ~3.7 lbf), and the burst pressure of a crimped connection is also low (e.g., ~30 psi). Therefore, both typical adhesive joint connections and typical crimped retainer ring connections are susceptible to leakage and separation.

[0021] 1, a typical infusion set 30 may include a drip chamber 40, a check valve 50, a roller clamp 60, and a Y-junction 70, all connected together by tubing 20. A typical infusion set 30 may include additional infusion components and may be formed from any combination of components and tubing 20.

[0022] As shown in FIGS. 2-6, an IV component / tubing connection is depicted as connection assembly 100. Connection assembly 100 includes an SMP ring 110 formed from an SMP material that expands or contracts based on an external stimulus (e.g., temperature, heat, moisture). As shown in FIG. 1, SMP ring 110 is in a contracted state 110a, and as shown in FIG. 2, SMP ring 110 is in an expanded state 110b. IV component 125 (e.g., drip chamber, check valve) has a component connector 120 (e.g., drip chamber connector, check valve connector) that includes a receptacle 122 sized and shaped to receive tubing 130 (e.g., IV tubing), which slidably engages an inner surface 132 of tubing 130. Tubing 130 may require some level of force to slide (e.g., a friction fit) into receptacle 122. Component connector 120 may also include barbs 124, as shown in FIG. 4, although barbless spigots are also contemplated in some aspects of the present disclosure. Barbs 124 may enhance the friction fit of tube 130 with component connector 120.

[0023] In use, the SMP ring 110, in its expanded state, is slidably moved along the tube 130 until the SMP ring 110 is positioned over the receptacle 122. The SMP ring 110 must be expanded sufficiently to fit over the tube 130 and the barbs 124 of the receptacle 122. As shown in FIG. 5 , the SMP ring 110 is then subjected to an appropriate external stimulus that causes the SMP ring 110 to contract to a contracted state, thus forcing (e.g., crushing, crimping, or pinching) the tube 130 against the receptacle 122, creating a bonded connection. The tube 130 is strongly held by the connection assembly 100 and therefore requires a higher pull-out force and a higher burst pressure to fail than a typical IV connection due to the higher friction fit and stronger SMP ring 110, respectively.

[0024] In some aspects of the present disclosure, adding a solvent / adhesive to the connection assembly 100 can provide an even stronger bond between the tube 130 and the spigot 122. As shown in FIG. 7A, which is an axisymmetric cross-section of a full 360-degree adhesive bond, a quantity of solvent / adhesive 150 can be applied to the barb 124 of the spigot 122, and the tube 130 can be engaged with the spigot 122. The solvent / adhesive acts as a lubricant to reduce the maximum insertion force of the tube. As shown in FIG. 7B, the tube 130 is slidably moved over the barb 124 and into the spigot 122 such that the inner surface 132 of the tube 130 engages the barb 124 and several portions of the spigot 122 before and after the barb 124. Here, a portion of the solvent / adhesive 150 is placed between the inner surface 132 and a portion of the spigot 122 just beyond the barb 124 to form a mechanical interface after curing, further preventing tube pull-out, and another portion of the solvent / adhesive 150 is placed at the end of the tube 130 along a portion of the spigot 122 to form a complete seal when the tube end is left flared open.

[0025] In some aspects of the present disclosure, the SMP ring 110 may be in a contracted state 110a prior to assembly, then change to an expanded state 110b upon exposure to an external stimulus for assembly to the tube 130 and receptacle 122, and then change back to the contracted state 110a upon exposure to another external stimulus. For example, the SMP ring 110 may be in the contracted state 110a at room temperature, change to the expanded state 110b upon exposure to a particular temperature above room temperature, and change back to the expanded state 110a upon exposure to a temperature below room temperature. In some aspects of the present disclosure, the SMP ring 110 is in the expanded state 110b prior to assembly (e.g., at room temperature), and then change to the contracted state 110a upon exposure to an external stimulus (e.g., an activation temperature).

[0026] As shown in FIGS. 8-12, an IV component / tubing connection is illustrated as connection assembly 200. Connection assembly 200 includes an SMP connector 210 (e.g., an IV component connector) formed from an SMP material that expands or contracts based on an external stimulus (e.g., temperature, heat, moisture). SMP connector 210 includes a shaft 212 (e.g., an inner portion) sized and shaped to slidably engage an inner surface 132 of tubing 130. SMP connector 210 also includes a compression flange 214 (e.g., an outer portion) sized and shaped to slidably engage an outer surface 134 of tubing 130. Here, when tubing 130 is connected or mated with SMP connector 210, tubing 130 is sandwiched in a gap 216 between shaft 212 and compression flange 214.

[0027] As shown in FIG. 8 , the SMP connector 210 is in a contracted state 210a. In the contracted state 210a, the compression flange 214 can be parallel to the shaft 212, such that the gap 216 has an essentially uniform or constant thickness. As shown in FIG. 9 , an expansion tool 250 (e.g., a flaring tool) can be inserted into the SMP connector 210 and / or the SMP connector 210 can be pressed against the expansion tool 250, causing portions of the compression flange 214 to expand (e.g., flare) away from the shaft 212. For example, the compression flange 214 can flare into a funnel shape. The resulting shape causes the SMP connector 210 to be in an expanded state 210b, as shown in FIG. 10 . Here, the gap 216 is wider at the tube insertion end 218 of the SMP connector 210, and the gap 216 narrows away from the tube insertion end 218, with the deepest portion of the gap 216 maintaining the same width as in the contracted state 210a.

[0028] In use, as shown in FIG. 11 , the tube 130 is slidably moved into the SMP connector 210 in the expanded state 210b so that the tube 130 is positioned in the gap 216 between the shaft 212 and the compression flange 214. An external stimulus (e.g., an activation temperature) can then be applied to the SMP connector 210 to contract or shrink the compression flange 214 back to the contracted state 210a (e.g., return to its original shape), as shown in FIG. 12 . Thus, the general process can be viewed as training the shape memory material of the SMP connector 210 at an elevated temperature (e.g., an injection molding temperature) that results in the contracted state 210a, then deforming the SMP connector 210 at a lower temperature (e.g., flaring the compression flange 214 using an expansion tool 250), and then activating the shape memory material of the SMP connector 210 at a transition temperature. Similarly, this process can be performed with SMP materials that have heat-activated properties, moisture-activated properties, etc.

[0029] In some aspects of the present disclosure, the SMP ring 110 and / or SMP connector 210 may be formed, for example, from a polyurethane SMP material. The polyurethane SMP material may be 3D printed, 4D printed, prepared by conventional extrusion, prepared by conventional molding, etc. The SMP material properties may be defined such that the modulus of elasticity changes below the glass transition temperature (e.g., a rigid state) and above the glass transition temperature (e.g., a soft state). Thus, above the glass transition temperature, the SMP material can be shaped by applying a low force or stress, and when the force / stress is removed below the glass transition temperature, the shaped shape is retained. Heating the shaped SMP material above the glass transition temperature without applying force or stress removes distortion from the shaped shape and the SMP material changes back to its original shape.

[0030] In some embodiments of the present disclosure, extrusion-grade commercially available materials can be extruded at various drawdown ratios and internal air pressures to customize the uniaxial orientation of the SMP ring 110 and / or SMP connector 210. Material type, glass transition temperature, wall thickness, and crystallization ability can affect part appearance, response to changes in extrusion parameters, shrinkage onset temperature, amount of shrinkage, and part strength. For example, soft PVC, TVU, or TPE blends containing PP, EVA, and / or LDPE can be used in the SMP ring 110 and / or SMP connector 210 (e.g., shrinkable tubing bushings).

[0031] In some embodiments of the present disclosure, custom compounds with thermally responsive materials can be extruded. The custom compounds can be designed to retain their expanded dimensions from the extruder's water bath. The material's turbidity can be designed to allow it to begin shrinking upon losing water or solvent content at elevated temperatures (e.g., the material begins to shrink as moisture or solvent is removed). For example, PNIPAAm can be used to tailor these properties, as shown in Figure 13. PNIPAAm or similar additives with thermally responsive properties can be blended with, for example, EVA, poly(ethylene glycol), TPU, TPE, or melt-processable polybutadiene.

[0032] In some aspects of the present disclosure, the material may be designed to mold or assume an expanded state after extrusion in the presence of a solvent that acts as an assembly lubricant, and then change to a contracted state upon application of temperature to facilitate assembly.

[0033] In some aspects of the present disclosure, polynorbornene, thermosetting resin, or other types of thermosetting resin may be used to form the SMP ring 110 and / or the SMP connector 210.

[0034] In some aspects of the present disclosure, polymer compatibility, solvent selection, thermally responsive material selection, compound stability during and after extrusion, and selection of a "good solvent" can be some of the variants that affect the performance of the thermally responsive polymer of the SMP ring 110 and / or SMP connector 210.

[0035] In some aspects of the present disclosure, the type of die and tooling may be a variation on the uniaxially oriented tubing of the SMP ring 110 and / or SMP connector 210.

[0036] It is understood that any particular order or hierarchy of blocks in the disclosed process methods is an example of an example approach. Based on design or implementation preferences, it is understood that the particular order or hierarchy of blocks in the processes may be rearranged, or all of the blocks shown may be performed. In some implementations, any of the blocks may be performed simultaneously.

[0037] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0038] Reference to an element in the singular is intended to mean "one or more" and not "one and only one" unless specifically so stated. The term "some" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her and its) and vice versa. Headings and subheadings, if any, are used merely for convenience and do not limit the invention.

[0039] 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 to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0040] As used herein, the phrase "at least one of," following a list of items, when followed by the word "or" separating any of those items, modifies the list as a whole and not each item in the list. The phrase "at least one of" does not require the selection of at least one item; rather, the phrase allows for the inclusion of at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. Illustratively, the phrase "at least one of A, B, or C" can refer to A only, B only, or C only, or any combination of A, B, and C.

[0041] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure of an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. A phrase such as "aspect" may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure of an embodiment may apply to all embodiments or one or more examples. An embodiment may provide one or more examples. A phrase such as "embodiment" may refer to one or more examples, and vice versa. A phrase such as "configuration" does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. Disclosure of a configuration may apply to all configurations or one or more configurations. A configuration may provide one or more instances. A phrase such as a configuration may refer to one or more configurations, and vice versa.

[0042] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth herein, including those in the claims that follow, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and the practice in the art to which they pertain.

[0043] It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is an illustration of example approaches. Based on design preferences, it is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged. Some of the steps, operations, or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically, without user intervention. If any method claims follow, the various steps, operations, or process elements are presented in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0044] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for." Moreover, to the extent terms such as "include," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprise," as "comprise" would be interpreted when used as a transitional phrase in a claim.

[0045] The title, background art, summary, brief description of the drawings, and abstract of this disclosure are hereby incorporated by reference into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description of the disclosure. This disclosure is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. Furthermore, in the detailed description, it will be appreciated that the description provides illustrative examples, and that various features have been grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the appended claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The appended claims are hereby incorporated by reference into the detailed description, with each claim standing on its own as separately claimed subject matter.

[0046] The claims are not intended to be limited to the embodiments described herein, but are to be accorded full scope consistent with the language of the claims and encompass all legal equivalents. However, none of the claims are intended, and should not be construed, to encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. 1. A connection assembly for an intravenous (IV) component, comprising: a shape memory polymer (SMP) connector formed from a shape-changing material, the SMP connector comprising: a shaft configured to slidably receive an inner surface of an IV tube; a compression flange configured to slidably receive an outer surface of the IV tube, the shaft, compression flange, and the IV tube forming a connector / tube connection; a gap provided between the shaft and the compression flange; In an expanded state, the compression flange is expanded and the gap at the tube insertion end of the SMP connector has a first width; In a contracted state, the compression flange is narrowed and the gap at the tube insertion end of the SMP connector has a second width that is narrower than the first width; The linkage assembly, wherein the shape-changing material is configured to change to one of the expanded state and the contracted state upon receiving an external stimulus.

2. 2. The linkage assembly of claim 1, wherein the compression flange is expanded to the expanded state by a force applied by an expansion tool, and the compression flange is contracted to the contracted state by application of a temperature change to the compression flange.

3. The linkage assembly of claim 1 , wherein the expanded state of the compression flange is funnel-shaped and the contracted state of the compression flange is cylindrical.

4. The coupling assembly of claim 1 , further comprising one of a solvent bond and an adhesive bond disposed between one of the shaft and the compression flange and the inner surface of the IV tube.

5. 2. The linkage assembly of claim 1, wherein the shape-changing material comprises poly(N-isopropylacrylamide) (PNIPAAm) blended with one of EVA, poly(ethylene glycol), TPU, TPE, or melt-processible polybutadiene, and wherein the cloud point of the shape-changing material is configured to cause the shape-changing material to shrink to the contracted state upon loss of moisture content when an elevated temperature is applied.

6. an intravenous (IV) set component; an IV tube; a connection assembly for connecting the IV tubing to the IV set components, comprising: a component connector configured to slidably receive an inner surface of the IV tube; a shape memory polymer (SMP) member formed from a shape-changing material; and Including, the coupling assembly is configured to allow slidable movement of the IV tubing relative to the component connector when the SMP member is in an expanded state; the coupling assembly is configured to securely hold the IV tubing to the component connector when the SMP member is in a contracted state; the shape-changing material is configured to change to one of the expanded state and the contracted state upon receiving an external stimulus; The component connector is a shaft that engages an inner surface of the IV tubing, and the SMP member is a compression flange that engages an outer surface of the IV tubing, the compression flange comprising: a flared shape in the expanded state, wherein a gap between the shaft and the compression flange has a first width at a tube insertion end of the gap and a second width at a base of the gap, the first width being greater than the second width; a cylindrical shape in the contracted state, wherein the first width of the gap is the same as the second width of the gap. Infusion set assembly.

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