Low-absorption multilayer medical tubing

Abstract

Medical tubing can have a continuous inner layer with a continuous outer layer on the surface, the inner layer containing polyethylene, polypropylene, or a polyolefin such as a functionalized polyolefin. The outer layer can contain a thermoplastic polymer such as one or more of thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), styrene-based block copolymer (SBC), or a mixture containing these. Advantageously, the outer and / or inner layers do not contain polyvinyl chloride. Such tubing material can be readily solvent-bonded to medical connectors and used with infusion sets.

Description

Technical Field

[0001] The present disclosure generally relates to tubing materials, and more particularly to flexible medical tubing materials that have low absorption of medical fluids and components therein, but are readily adhesable by solvent bonding to other medical components. Such tubing materials can be used for medical devices such as tubing materials for administering medical fluids by injection.

Background Art

[0002] Plastic tubing materials are widely used in the medical field, specifically for patient diagnostic and treatment procedures. However, medical tubing materials are subject to a variety of, sometimes incompatible, requirements. For example, medical tubing materials should be strong yet flexible or bendable, resistant to twisting, resistant to reacting with fluids, and should not allow detrimental chemicals to enter the fluid being transported therethrough. However, many plastic materials having such properties are inflexible. Many plastic materials having such properties are inert, making it difficult to bond such tubing by solvent bonding. However, in many applications, medical tubing materials are used with infusion pumps that pinch, clamp, or pressurize the tubing material to move fluid through the tubing material. In such applications, the tubing material needs to be flexible, easy to clamp, and quickly regain its shape. Flexible tubing materials such as polyvinyl chloride containing plasticizers have been used for many years in infusion sets. Unfortunately, plasticized polymeric materials such as plasticized polyvinyl chloride can be sticky and can clog and rupture the tubing material.

[0003] Therefore, there continues to be a need for medical tubing materials that can address the different requirements of medical applications.

Summary of the Invention

Means for Solving the Problems

[0004] The patented aspect of the technology relates to a medical tube material comprising or consisting of a continuous inner layer having a continuous outer layer on its surface. The inner layer may contain or consist of a polyolefin, and the outer layer may contain or consist of a thermoplastic polymer selected from thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), and styrene-based block copolymer (SBC). Advantageously, the medical tube material has at least 25% higher adhesive strength than a medical tube material consisting of a single layer of thermoplastic polymer. If the inner layer is harder than the outer layer, for example, has rigidity, such a configuration is thought to facilitate adhesion of the medical tube material to other medical components.

[0005] The inner layer of the polyolefin may consist of polyethylene, polypropylene, functionalized polyolefin, or a combination thereof, and the functionalized polyolefin can be selected from maleic anhydride-modified polyethylene, maleic anhydride-modified polypropylene, maleic anhydride-modified plastomer, amine-functionalized polyolefin, or a combination thereof. The outer layer may consist of a thermoplastic polymer, such as one or more of thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), styrene-based block copolymer (SBC), or a mixture thereof. Advantageously, the inner layer is harder than the outer layer, for example, it has rigidity. Such a configuration facilitates solvent bonding of the medical tubing material to other medical components. In addition, the outer and / or inner layers are advantageously free of polyvinyl chloride.

[0006] The patented technology also relates to a method for manufacturing medical tubing material by co-extruding a continuous inner layer having a continuous outer layer directly on the surface, wherein the inner layer contains or is made of a polyolefin, and the outer layer contains or is made of a thermoplastic polymer. This method may further include extruding a bonding layer between the continuous inner layer and the continuous outer layer. The manufactured medical tubing material can be formed to be transparent to visible light.

[0007] The patented technology also relates to medical tubes, such as those described above, that are bonded to medical connectors by solvent bonding.

[0008] The patented technology also relates to an infusion set comprising medical tubing material connected to one or more medical connectors, and to a method for manufacturing an infusion set comprising medical tubing material connected to one or more medical connectors by solvent bonding.

[0009] The embodiments of the medical tubing materials and methods described above include one or more of the following features individually or in combination. In some embodiments, the medical tubing material may further comprise a bonding layer between a continuous inner layer and a continuous outer layer. The bonding layer may include maleic anhydride-modified polypropylene, maleic anhydride-modified polyethylene, ethyl vinyl acetate copolymer, or a combination thereof. Alternatively, the inner layer may be in direct contact with the outer layer. Furthermore, in other embodiments, the medical tubing material may comprise a solvent-adhesive intermittent compartmental layer in direct contact with the outer layer, such as a solvent-adhesive intermittent compartmental layer of thermoplastic polyurethane.

[0010] In further embodiments, the infusion set can be fabricated by applying a thin layer of solvent to one or both of the surfaces of a medical tubing material and / or a medical connector, and holding the surfaces of the tubing material and the medical connector together until a seal is formed between them. In some embodiments, the medical connector comprises an acrylic-based polymer.

[0011] Further advantages of the patented technology will be readily apparent to those skilled in the art from the following detailed description, but the detailed description only illustrates and describes a few aspects of the patented technology. The patented technology can be made into other different configurations to be implemented, and some of its details can be modified in various other ways without departing from the patented technology. Accordingly, the drawings and description should be considered illustrative rather than restrictive.

[0012] The accompanying drawings, which have been adopted to provide a further understanding and which are incorporated into and constitute part thereof in this specification, serve to illustrate the embodiments disclosed and to illustrate the principles of the embodiments disclosed together with the description. [Brief explanation of the drawing]

[0013] [Figure 1]This is a diagram of an exemplary medical tube having a continuous inner layer and a continuous outer layer according to an aspect of the present disclosure. [Figure 2] This is a diagram of another exemplary medical tube according to an aspect of the present disclosure, comprising a continuous inner layer, a continuous outer layer on the surface of the inner layer, and a bonding layer between the continuous inner layer and the continuous outer layer. [Figure 3] This is a diagram of a multi-material polyolefin backing layer for medical use, which includes a continuous polyolefin inner layer, a continuous outer layer, and a solvent-bondable, intermittent compartmental layer in direct contact with the outer layer. [Figure 4] This bar graph shows the maximum load (in Newtons) required to break a medical tubing material connected to a medical connector. The graph compares a medical tubing material (control group) consisting of a single layer of polymer material ("mono") with a medical tubing material having a thermoplastic polymer with a polyolefin backing layer, and further compares such tubing materials with medical tubing materials manufactured by alternative extrusion technology (AET). [Figure 5] This figure shows how several variables affect the extrusion molding of medical tubing materials. [Figure 6] This figure shows the effect of adjusting several variables during extrusion molding on the resulting adhesion strength. [Modes for carrying out the invention]

[0014] The detailed descriptions below describe various configurations of the patented technology and are not intended to represent only the configurations in which the patented technology can be implemented. The detailed descriptions include specific details necessary for a complete understanding of the patented technology. Therefore, dimensions are given as non-limiting examples in some embodiments. However, it will be apparent to those skilled in the art that the patented technology can be implemented even without these specific details. In some cases, well-known structures and components are shown in block diagrams to avoid obscuring the concept of the patented technology.

[0015] This disclosure includes examples of the patentable technology, but should be understood not to limit the scope of the attached claims. Various aspects of the patentable technology are disclosed below by specific but non-limiting examples. The various embodiments described in this disclosure may be carried out in different ways and variations according to the desired application or practice.

[0016] The patented aspect of the technology relates to medical tubing materials that can meet the requirements of different properties. To overcome the technical challenges arising from conflicting design requirements for medical tubing materials, advanced material formulations and structures are necessary for such tubing materials. For example, medical tubing materials should be able to be bonded to joints and other components for connecting tubing materials by solvent bonding, for example, because solvent bonding is relatively easy, convenient, and cost-effective. Furthermore, medical tubing materials should simultaneously be resistant to absorption by medical fluids and their components without significantly altering the tubing material itself or any active pharmaceutical ingredient (API). This requires the material to be inert for drug compatibility and solvent-reactive for solvent bonding, which are usually conflicting requirements for a single material. Additionally, there is a preference for more environmentally friendly materials and a preference to eliminate polyvinyl chloride (PVC). The tubing material also needs to be rigid enough to allow for cutting processes, although it is not expected to fully recover its rigidity, for manufacturability.

[0017] In some embodiments, the patented technology relates to a medical tubing material comprising a continuous inner layer having a continuous outer layer on its surface. Advantageously, the inner layer contains or is composed of a polyolefin with low absorption properties, thereby the polyolefin inner layer resists absorbing medical fluids and / or components thereof, or affecting any active pharmaceutical ingredients (APIs) transported through the tubing material. In addition, the polyolefin inner layer also resists alteration of the tubing material itself due to the transport of medical fluids through it.

[0018] In some embodiments, the continuous inner layer may contain or consist of a functionalized polyolefin such as maleic anhydride-modified polyethylene (e.g., high-density polyethylene (HDPE) or low-density polyethylene (LDPE)), maleic anhydride-modified polypropylene, maleic anhydride-modified plastomer, or a combination thereof. Such a functionalized polyolefin facilitates adhesion between the inner and outer layers.

[0019] Advantageously, the inner layer is harder than the outer layer, for example, it has rigidity. Such a configuration facilitates solvent bonding of the medical tubing material to other medical components. For example, the inner layer may have a tensile coefficient in the range of approximately 1800 to 3000 MPa, such as approximately 1000 MPa to 2000 MPa. The yield tensile stress (MPa) can be determined by DIN (Deutsches Institut für Normung) 53504, the elongation at break (%) by DIN 53504, and the Shore D hardness by DI 53505.

[0020] The outer layer can include a polymer material different from the inner layer or be made of a polymer material different from the inner layer so that the outer surface of the tube material can have properties different from those of the inner layer material. For example, the outer layer can include a thermoplastic polymer or a mixture thereof, such as one or more of thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), styrene block copolymer (SBC), or a mixture thereof. The thermoplastic polymers useful as the outer layer can be further mixed with other polymer components and / or additives. For example, the thermoplastic polymers useful as the outer layer can be further mixed with, for example, acrylic-based TPE of up to 15 wt% or more of the mixture, adhesion promoters such as polar functionalized polyolefins, adhesion imparting agents, and clarifying agents of up to 10 wt% of the mixture. Many of the thermoplastic polymers have properties advantageous for the outer layer of medical tube materials, such as thermoplastic polyurethane (TPU) and styrene-containing thermoplastic elastomer (S-TPE), and this property is useful for solvent bonding the outer layer of the tube material. Alternatively or in combination, many of the thermoplastic polymers advantageously improve the flexibility of the tube material.

[0021] In some embodiments of the medical tube material of the present disclosure, a bonding layer can be included between the continuous inner layer and the continuous outer layer.

[0022] Advantageously, the medical tube material of the present disclosure does not contain polyvinyl chloride. That is, the outer layer and / or the inner layer and / or the bonding layer, if present, do not contain polyvinyl chloride.

[0023] In some embodiments, the medical tube material of the present disclosure can have a Shore A hardness greater than about 85 or less than about 85. When the Shore A of the medical tube material is greater than 85, it is usually considered hard. In pump tube materials, a more flexible tube material having a Shore A hardness of less than about 65, for example 55 or less, is usually employed.

[0024] The medical tube material of the present disclosure can be used as a medical tube material for administering medical fluids, such as an intravenous assembly for transporting intravenous fluids to a patient, a gravity container, and / or an infusion pump. A tube material, valve, fixture, and needle assembly for connecting a fluid container into a patient's vein may be referred to as an "IV (intravenous) set". An infusion pump is a medical device that can be used to administer intravenous (IV) fluids. In such assemblies, containers, and pumps, a tube material coupled to one or more medical connectors is used, and thus the tube material of the present disclosure is useful.

[0025] For example, the tube material of the present disclosure can be easily meshed and coupled to a medical connector or other medical parts by applying a thin layer of solvent to one or both of the contact surfaces and then holding the two surfaces in place until a seal is formed between them. The contact surface of the tube material can be the outer surface of the outer layer, and the contact surface of the medical connector can be the recess or inner surface of the connector. Medical connectors that can benefit from the tube material of the present disclosure include, but are not limited to, connectors made from acrylic-based polymer materials such as acrylonitrile-butadiene-styrene (ABS), methyl methacrylate-acrylonitrile-butadiene-styrene (MABS), acrylic-polycarbonate-based materials, polyester, polycarbonate, acrylic, and polyvinyl chloride.

[0026] In one embodiment of this application, a medical tubing material according to the present disclosure can be readily bonded to a medical connector by solvent bonding. As described in the preceding paragraphs, solvent bonding involves bonding a thin layer of solvent to one or both of the medical tubing material and the medical connector. For example, a thin layer of solvent may be bonded to the outer surface of the medical tubing material so that the tubing material can be inserted into the inner surface (e.g., a recess or other element) of the medical connector, or a thin layer of solvent may be bonded to the inner surface of the medical connector so that the tubing material can be inserted into the inner surface, or both. The two surfaces having one or both of the bonded solvents (e.g., the surface of the tubing material and the surface of the connector) are then brought together and held in place until a seal is formed between them.

[0027] The solvents that can be used to solvent-bond the tube material of this disclosure include, but are not limited to, one or more of the following: alcohols such as methanol, ethanol, isopropanol, propanol, butanol, pentanol, and benzyl alcohol; glycols such as diethylene glycol and propylene glycol; ethers such as dioxolane, tetrahydrofuran, and 1,3-dioxane; ketones such as acetone, methyl ethyl ketone, and cyclohexanone; esters such as ethyl acetate and ethyl formate; amides such as dimethylformamide, dimethylacetamide, diethylacetamide, and N-methylpyrrolidone; sulfoxides such as dimethyl sulfoxide; hydrocarbons such as hexane and toluene; and chlorinated solvents such as methylene chloride.

[0028] Table 1 below lists examples of medical tubing material compositions that can be used in accordance with this disclosure. Such medical tubing material compositions and material formulations can meet many of the requirements of Set IV and other requirements for medical tubing material.

[0029] [Table 1]

[0030] As shown in Table 1, the continuous inner layer can consist of amine-functionalized polyolefin or maleic anhydride-modified polyolefin, or both. Such amine-functionalized polyolefins can be prepared by reaction extrusion molding, in which maleic anhydride-modified polyolefin (for example, selected from 1, 2, 3, and 4 in Table 1 above) is reacted with a polyetheramine. This formulation or the maleic anhydride-functionalized polyolefin can increase the compatibility between polyolefins, which are non-polar and have low surface energy, and more polar materials. In the tube structure shown in Table 1, good interlayer adhesion between the polar and non-polar materials is necessary, and therefore, this adjustment should increase the adhesion of the inner layer to the outer layer.

[0031] The two-layer polyolefin-backed TPU medical tubing structure described in Table 1 offers several advantages compared to the three-layer method, including increased production line speed / production volume, and, for example, faster and less complex co-extrusion operations than the three-layer method. Standard costs are expected to be lower than the three-layer method, and the functionalization of the polyolefin inner layer results in better layer adhesion compared to the poor adhesion of unmodified polyolefins due to the presence of compatibility resulting from the functionalization of the inner layer. Polyolefins also have the advantage of having low drug absorption properties.

[0032] Furthermore, in some embodiments, the continuous inner layer can be relatively thinner than the continuous outer layer, which should result in the tubing material having similar bulk properties to the continuous outer layer, such as a TPU outer layer. In addition, the ether-based TPU layer provides better solvent adhesion, and the selection of an aliphatic main skeleton provides better color stability in certain situations.

[0033] Figure 1 shows an example of a medical tube with a double-layer polyolefin backing. Such a structure can be used, along with the polymer materials listed in Table 1 above, to provide a solvent-bondable, low-absorbent double-layer polyolefin TPU medical tube. As shown in the figure, the double-layer medical tube includes an inner layer (10) and an outer layer (12) that is directly present on the surface of the inner layer.

[0034] For use in applications including IV sets and / or infusion pumps, the tubing material of this disclosure can have an inner diameter for fluid to flow through it in the range of about 1.5 mm to about 6 mm, for example, 2 mm to 4 mm. The total thickness of the side can be in the range of about 0.2 mm to about 1 mm, such as 0.4 mm to 0.6 mm. In some embodiments of this disclosure, the outer layer can account for 10 to 90% of the side thickness, and the inner layer can account for 90 to 10% of the side thickness. In one embodiment, the outer layer can have a thickness of about 0.01 mm to about 0.5 mm, for example, about 0.05 mm to about 0.2 mm, and the inner layer can have a thickness of about 0.01 mm to about 0.8 mm, for example, about 0.0038 mm (about 0.0015 inches), for example, about 0.02 mm to about 0.1 mm.

[0035] Table 2 below shows another example of the structure of medical tubing materials that can be used by this disclosure.

[0036] [Table 2]

[0037] As shown in Table 2, medical tubing can comprise a continuous inner layer, a continuous outer layer on the surface of the continuous inner layer, and a bonding layer between the continuous inner and continuous outer layers. As shown in Table 2, the inner layer can contain polyolefins such as polypropylene or polyethylene (e.g., linear low-density polyethylene (LDPE)). The outer layer can contain thermoplastic polyurethane (TPU), which may be useful for solvent bonding the outer layer of the tubing material. Medical tubing material can also comprise a bonding layer between the continuous inner and continuous outer layers. Such a bonding layer can comprise functionalized polyolefins such as maleic anhydride-modified polypropylene or maleic anhydride-modified polyethylene, or copolymers of other bonding layers such as ethyl vinyl acetate copolymer (EVA (ethyl vinyl acetate) copolymer), or combinations thereof.

[0038] The structure of the three-layer polyolefin-backed TPU medical tubing material described in Table 2 offers several advantages, including compatibility without the need for more expensive functionalized polymers by selecting a compatible main skeleton by combining PP with PP-based TPO or POP, and PE with PE-based TPO or POE, and having a PP or PE-based inner layer.

[0039] Furthermore, in some embodiments, the continuous inner layer can be relatively thinner than the continuous outer layer, which should result in the tubular material having bulk properties similar to those of the TPU layer. In addition, the ether-based TPU layer provides better solvent adhesion, and the selection of an aliphatic main skeleton provides better color stability in certain situations.

[0040] Figure 2 shows an example of a medical tube with a three-layer polyolefin backing. Such a structure can be used, along with the polymer materials listed in Table 2 above, to provide a solvent-bondable, low-absorbent polyolefin backing TPU medical tube with a bonding layer. As shown in the figure, the three-layer medical tube includes an inner layer (20), an outer layer (22), and a bonding layer (24) located between the inner layer (20) and the outer layer (22) and in direct contact with both.

[0041] For use in applications including IV sets and / or infusion pumps, the tubing material of this disclosure can have an inner diameter for fluid to flow through it in the range of about 1.5 mm to about 6 mm, for example, 2 mm to 4 mm. The total thickness of the side can be in the range of about 0.2 mm to about 1 mm, such as 0.4 mm to 0.6 mm. In some embodiments of this disclosure, the outer layer can account for 10 to 90% of the side thickness, and the inner layer can account for 90 to 10% of the side thickness. In one embodiment, the outer layer can have a thickness of about 0.1 mm to about 0.8 mm, for example, about 0.5 mm to about 0.5 mm, and the inner layer can have a thickness of about 0.01 mm to about 0.5 mm, for example, about 0.05 mm to about 0.2 mm.

[0042] Figure 3 illustrates a medical tube with a polyolefin backing layer made of multiple materials. Such a structure can be used to provide a medical tube with a polyolefin backing layer that is solvent-adherent and has low absorption. As shown in the figure, the medical tube comprises a continuous polyolefin inner layer (30) and a continuous outer layer (34). In this example, the medical tube material further comprises a solvent-adherent intermittent compartmental layer (32) that is in direct contact with the outer layer (34). The solvent-adherent intermittent compartmental layer may contain a thermoplastic polyurethane such as TPU, which has good solvent adhesion ability.

[0043] Table 3 below shows another example of the configuration of medical tubing materials that can be used in accordance with this disclosure.

[0044] [Table 3]

[0045] As shown in Table 3 above, medical tubing can comprise a continuous inner layer and a continuous outer layer on the surface of the continuous inner layer. The continuous inner layer may include polyethylene (e.g., LDPE, HDPE) or unfunctionalized polyolefins such as polypropylene. The continuous outer layer may include polyolefin elastomers (POE), such as ethylene-octene polyolefin elastomer, ethylene-butene polyolefin elastomer, polyolefin plastomer (POP), propylene elastomer, and other thermoplastic polymers or mixtures thereof.

[0046] Many thermoplastic polymers, including thermoplastic elastomers (TPEs) and thermoplastic olefins, useful for the outer layers of the medical tubing materials of this disclosure, can be mixed with polyolefins to optimize cost, increase crystallinity, enhance mechanical strength, increase operating range, i.e., environmental stability and shelf life, and improve material compatibility, i.e., interlayer adhesion to the inner layer. The following are some different modifications that can overcome some of the shortcomings of thermoplastic polymers derived from s-TPEs and TPOs.

[0047] Specialized styrene-based block copolymer (SBC) compounds: Several classes of SBC are useful due to their flexibility and reaction to solvents, i.e., their adhesive properties. However, some of our experiments have shown that they exhibit inferior torsional resistance compared to other polymer types of styrene-based TPEs. Furthermore, some classes of SBC lack high-temperature resistance, as can be seen from their low softening points. Similarly, several classes of POP and POE, such as Engage's reactor-based TPO, lack high-temperature resistance, as can be seen from their low softening points. Tables 4-5 describe examples of thermoplastic polymer formulations that can be used as continuous outer layers of medical tubing materials according to this disclosure.

[0048] Mixing of SBC with random PP copolymer: Mixing of SBC with random PP copolymer creates a solvent-bondable and torsion-resistant material for the tubing material itself or for the solvent adhesive layer. The mixing ratio may vary from 5 to 95% of the amount of additional (ethylene or propylene-based) olefin component, which should be further refined based on transparency requirements. These mixtures may also contain up to 15 wt% of acrylic-based TPE or polar functionalized polyolefins as tack enhancers. With these types of compounds, it is customary to add up to 10 wt% of tackifiers, fining agents, and polymer processing aids if it is necessary to modify the melt-flow properties and transparency of the tubing material. Various processing variables can affect the transparency and mechanical properties of the tubing material.

[0049] Mixing of temperature-resistant TPOs such as random PP copolymers, polyolefins, or olefin block copolymers with TPO. The mixing ratio may vary from 5 to 95% of the olefin component (ethylene or propylene-based), and this can be adjusted based on transparency requirements. These mixtures may also contain tackifiers such as acrylic-based TPEs or polar functionalized polyolefins in up to 15 wt% of the mixture. With these types of compounds, it is customary to add up to 10 wt% of tackifiers, fining agents, and polymer processing aids (of the mixture) if it is necessary to modify the melt flow properties and transparency of the tubing material. Various variables of the process can affect the transparency and mechanical properties of the tubing material.

[0050] [Table 4]

[0051] [Table 5]

[0052] The structure of the two-layer polyolefin-backed thermoplastic polymer medical tubing material, as shown in Table 3, offers several advantages compared to the three-layer method, including increased processing cycle time, and, for example, faster co-extrusion operation and lower complexity than the three-layer method. The cost is expected to be lower than the three-layer method, the compatibility of the inner layers improves layer adhesion, and the inclusion of an unfunctionalized polyolefin inner layer results in lower drug absorption properties.

[0053] Advantageously, the medical tubing materials of this disclosure have at least 25% higher adhesive strength than medical tubing materials composed of a single layer of thermoplastic polymer, such as at least 50%, 75%, and 100% higher. To demonstrate the adhesive strength of the medical tubing materials of this disclosure, several medical tubing configurations have been fabricated and compared to medical tubing materials (referred to as "mono" tubing) that are composed solely of thermoplastic polymer but otherwise have the same dimensions as two-layer medical tubing materials. Since polyolefin inner layers do not undergo significant solvent adhesion, if present, there is no need to compare them with single-layer medical tubing materials made of polyolefin material.

[0054] The medical tubing materials described in Tables 6A and 6B below were solvent-bonded to Luer connectors made of mABS Terlux® 2802HD. The maximum force required to break the tubing / connection assembly was recorded with an Instron at a tensile speed of 50.8 cm / min (20 inches) (bonding strength). Table 6C describes some of the properties of several inner layers.

[0055] [Table 6]

[0056] [Table 7]

[0057] [Table 8]

[0058] The data in Table 6B were obtained using DIN53479 (density, g / cm3), and hardness can be determined using Shore D (DIN53505), yield tensile stress (MPa) (DIN53504), and elongation at break (%) (DIN53504). The ratio of inner wall thickness to total wall thickness was approximately 20%, and the ratio of outer wall thickness to total wall thickness was approximately 80%.

[0059] The results of the Instron test are shown in Figure 4. As shown in Figure 4, the maximum load (Newtons) (adhesion strength) required to break an assembly of medical tubing materials coupled to a medical connector (e.g., Luer) was significantly higher for medical tubing materials with a polyolefin backing layer thermoplastic polymer compared to medical tubing materials composed of only a single layer ("mono") of polymer material (control group). This is demonstrated by comparing TPU2 with a PE1 backing layer and TPU2 with a PE2 backing layer (polyolefin backing layer thermoplastic polyurethane) with adhesion strengths of approximately 44 N and 42 N, respectively, with mono-TPU2 with an adhesion strength of approximately 22 N.

[0060] Medical tubing materials with a polyolefin-backed thermoplastic polymer exhibit approximately 100% to 91% higher adhesive strength compared to medical tubing composed of a single layer of thermoplastic polymer. The same trend is evident when comparing styrene-based thermoplastic elastomers with a polyolefin-backed layer (PE-backed TPE2) to single-layer thermoplastic elastomers (mono-TPE2). As shown in Figure 4, TPE with a polyolefin-backed layer exhibits approximately 67% higher adhesive strength. Increased adhesive strength is also demonstrated in medical tubing materials manufactured using alternative extrusion molding (AET) techniques.

[0061] The outer layer of the tubing material allows for solvent bonding to recessed joints of medical connectors, such as connectors containing a rigid acrylic base material. If the inner layer is harder than the outer layer, for example, if it has rigidity, this configuration is thought to facilitate solvent bonding of the medical tubing material to other medical components.

[0062] The medical tubing materials of this disclosure can be manufactured by extrusion molding. For example, the medical tubing materials of this disclosure can be co-extruded as a continuous inner layer having a continuous outer layer on the surface, wherein the inner layer contains a polyolefin and the outer layer contains a different polymer material from the inner layer. It is preferable to produce a clear medical tubing material, for example, one that is transparent to visible light. Extruding clear tubing materials presents a series of challenges, and differences between clear and dull tubing materials can arise depending on the following processing variables. Clarity is affected by die temperature, tool design, and parison exhaust.

[0063] Die Temperature: (a) Die temperature interacts with the surface finish of the tube material and affects its transparency. Lowering the die temperature near the end of the die causes the outermost layer (surface) of the tube material to "stick" to the tool during extrusion. This sticking creates a difference in the rate at which the polymer melts from the inside to the outside, resulting in microscopic deformations ("cracks") on the surface. These cracks give the tube material an opaque or "matte" appearance. (b) Conversely, increasing the die temperature reduces the difference in the rate at which the polymer melts from the inside to the outside, contributing to a more transparent tube material and reducing the microscopic deformations that appear on the surface.

[0064] Tool Design: (a) Extrusion tools can have a similar effect on surface finish as die temperature. Reducing friction between the tool material and the polymer molten material will result in a more uniform polymer melting rate across the parison. This reduction in friction can be achieved by applying a finishing or coating process to the tool.

[0065] Parison ventilation: (a) The last process parameter that may affect the transparency of the tubing material is the placement of the parison exhaust. The purpose of the exhaust is to exhaust any gases from the parison during extrusion and is usually placed directly above the parison. Exhausts with larger openings can be placed further away from the parison to capture any gases, but small snake-shaped exhausts will have to be placed within a few centimeters (a few inches) of the parison. If the exhaust is placed too close to the parison, the parison will be affected by air suction, which will alter the surface finish of the tubing material and may result in an opaque / matte finish. (b) This is similar to the matte extrusion process in which cooled air is blown directly into the parison during extrusion.

[0066] Figure 5 shows how articles can be affected during extrusion molding, and Figure 6 shows the effect of adjusting several variables during extrusion molding on adhesive strength.

[0067] Additional considerations In some embodiments, any provision of this specification may depend on any independent provision or any dependent provision. In one embodiment, any provision (e.g., a dependent provision or an independent provision) may be combined with any other provision (e.g., a dependent provision or an independent provision). In one embodiment, a claim may include some or all of the words (e.g., steps, actions, means, or parts) contained in a provision, sentence, wording, or paragraph. In one embodiment, a claim may include some or all of the words contained in one or more provisions, sentences, wording, or paragraphs. In one embodiment, some of the words in each provision, sentence, wording, or paragraph may be removed. In one embodiment, additional words or elements may be added to a provision, sentence, wording, or paragraph. In one embodiment, the patentable technology may be implemented without using some of the parts, elements, functions, or actions described herein. In one embodiment, the patentable technology may be implemented using additional parts, elements, functions, or actions.

[0068] The patentable technology is illustrated, for example, according to the various embodiments described below. Various examples of the patentable technology are provided as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the subject technology. Any of the dependent clauses may be combined in any combination and incorporated into each independent clause, for example, Clause 1 or Clause 5. Other clauses may be presented similarly.

[0069] Clause 1. A medical tube material comprising a continuous inner layer having a continuous outer layer on its surface, wherein the inner layer comprises a polyolefin, and the outer layer comprises a thermoplastic polymer selected from thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), and styrene-based block copolymer (SBC), wherein the medical tube material has an adhesive strength at least 25% higher than a medical tube composed of a single layer of thermoplastic polymer.

[0070] Clause 2. A medical tubing material as described in Clause 1, wherein the inner layer is made of polyolefin and the outer layer is made of a thermoplastic polymer.

[0071] Clause 3. Polyolefin is a medical tubing material as described in Clause 2, consisting of polyethylene or polypropylene.

[0072] Clause 4. The polyolefin is a medical tubing material as described in Clause 2, comprising maleic anhydride-modified polyethylene, maleic anhydride-modified polypropylene, or a combination thereof.

[0073] Clause 5. The thermoplastic polymer is a thermoplastic urethane, as described in Clause 2.

[0074] Clause 6. The thermoplastic polymer is one or more of styrene-containing thermoplastic elastomers (S-TPE), polyolefin elastomers (POE), styrene-based block copolymers (SBC), or mixtures thereof, as described in any one of Clauses 1 to 5.

[0075] Clause 7. Medical tubing material as described in any one of Clauses 1 to 6, wherein the outer and inner layers do not contain polyvinyl chloride.

[0076] Clause 8. A medical tubing material as described in any one of Clauses 1 to 7, in which the inner layer is in direct contact with the outer layer.

[0077] Clause 9. Medical tubing material is any medical tubing material described in any one of Clauses 1 to 8, having a Shore A hardness of less than approximately 65.

[0078] Clause 10. An infusion set comprising medical tubing material as described in any one of Clauses 1 to 9, bonded to a medical connector by solvent adhesive.

[0079] Clause 11. The infusion set as described in Clause 10, wherein the medical connector comprises an acrylic-based polymer and the medical tubing material is bonded to an acrylic-based polymer.

[0080] Clause 12. The infusion set according to Clause 10, wherein the inner layer is made of polyolefin and the outer layer is made of a thermoplastic polymer.

[0081] Clause 13. An infusion set according to any one of Clauses 10 to 12, wherein the polyolefin consists of polyethylene or polypropylene, and the thermoplastic polymer consists of thermoplastic urethane.

[0082] Clause 14. A method for preparing an infusion set comprising a medical tubing material as described in any one of Clauses 1 to 9, comprising: applying a thin layer of solvent to one or both of the surfaces of the medical tubing material and / or a medical connector; and, after applying the thin layer of solvent, holding the surfaces of the medical tubing material and / or the medical connector together until a seal is formed between them.

[0083] Clause 15. The method according to Clause 14, wherein the solvent is applied to the outer layer of the tube material as the surface of the tube material.

[0084] Clause 16. Medical connectors comprising an acrylic-based polymer as described in Clause 14 or 15.

[0085] Clause 17. The method according to any one of Clauses 14 to 16, wherein the solvent includes one or more alcohols, glycols, ketones, esters such as ethyl acetate, amides, sulfoxides, or hydrocarbons.

[0086] Clause 18. The method according to any one of Clauses 15 to 17, wherein the inner layer is made of polyolefin and the outer layer is made of a thermoplastic polymer.

[0087] Clause 19. The method according to Clause 18, wherein the polyolefin consists of polyethylene or polypropylene.

[0088] Any specific order or hierarchy of blocks in the disclosed process method is to be understood as illustrating an example technique. Based on design or implementation preferences, the specific order or hierarchy of blocks in the process may be rearranged, or all described blocks may be performed. In some implementations, any of the blocks may be performed simultaneously.

[0089] This disclosure is provided to enable any person skilled in the art to implement the various embodiments described herein. This disclosure provides various examples of the patentable technology, and the patentable technology is not limited to these examples. Various variations of these embodiments will be readily apparent to a person skilled in the art, and the general principles set forth herein can be applied to other embodiments as well.

[0090] Unless otherwise specified, singular references to elements shall mean "one or more" rather than "one and unique." Unless otherwise specified, the term "several" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Headings and subheadings, if present, are for convenience only and do not limit the invention.

[0091] The word “exemplary” is used herein to mean “serving as an example or illustration.” Any embodiment or design described herein as “exemplary” is not necessarily construed to be preferable or advantageous to other embodiments or designs. In one embodiment, various alternative configurations and operations described herein can be considered at least equivalent.

[0092] In this specification, the phrase “at least one” preceding a set of items, which has the word “or” separating any of the items, modifies the entire enumeration rather than the corner items of the enumeration. The phrase “at least one” does not require the selection of at least one item; rather, it allows for meanings that include at least one of any one of the items and / or at least one of any combination of items and / or at least one of each of the items. For example, the phrase “at least one of A, B, or C” could refer to A only, B only, C only, or any combination of A, B, and C.

[0093] The phrases "aspects," etc., do not imply that such aspects are essential to the patented technology, or that such aspects constitute all configurations of the patented technology. Disclosure relating to one aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. Phrases such as "aspects," etc., may refer to one or more aspects, and vice versa. The phrases "examples," etc., do not imply that such examples are essential to the patented technology, or that such examples constitute all configurations of the patented technology. Disclosure relating to one example may apply to all examples, or one or more examples. An example may provide one or more examples. Phrases such as "examples," etc., may refer to one or more examples, and vice versa. The phrases "configuration," etc., do not imply that such configurations are essential to the patented technology, or that such configurations constitute all configurations of the patented technology. Disclosure relating to one configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. The phrase "composition, etc." may refer to one item or a manner of composition, and vice versa.

[0094] In one embodiment, unless otherwise specified, all measurements, values, grades, locations, sizes, dimensions, and other specifications described herein, including those in the following claims, are approximate and not exact. In one embodiment, they shall be within a reasonable range that is consistent with the function to which they pertain and with the conventions of the art to which they pertain.

[0095] The specific sequence or hierarchy of steps, actions, or processes disclosed is understood to be illustrative of the method. The specific sequence or hierarchy of steps, actions, or processes may be rearranged based on design preferences. Some steps, actions, or processes may be performed simultaneously. Some or all of the steps, actions, or processes may be performed automatically without user intervention. The claims for the attached methods present various elements of steps, actions, or processes, if any, in a sample sequence, and are not intended to be limited to the specific sequence or hierarchy presented.

[0096] All structural and functional equivalents of elements of various aspects described herein, known or to those skilled in the art, are expressly incorporated herein by reference and are included in the claims. Furthermore, nothing disclosed herein will be made public, whether such disclosure is expressly stated in the claims or not. Elements of the claims shall not be construed under Section 112(f) of the United States Patent Act unless they are expressly described using the phrase “means for” or, in the case of a method claim, “step for.” Furthermore, to the extent that terms such as “include” or “have” are used, such terms shall be non-exclusive, as “comprise” is construed when the term “comprise” is used as a transitional word in a claim.

[0097] The title, background, overview, brief description of the drawings, and summary of this disclosure are incorporated herein by reference and provided as descriptive examples of the disclosure, not as limiting statements. This is based on the understanding that they are not used to limit the scope or meaning of the claims. In addition, it can be seen that the detailed description provides descriptive examples and that various features are grouped into various embodiments in order to simplify the disclosure. Such a method of disclosure should not be interpreted as reflecting an intention that the subject matter of the claims requires more features than those explicitly described in each claim. Rather, as reflected in the following claims, the subject matter of the invention lies in fewer features than all the features of a single configuration or operation disclosed. In this way, the following claims are incorporated into the detailed description in such an independent manner that each claim is separately claimed subject matter.

[0098] The claims are not intended to be limited to the embodiments described herein, but should be granted the full scope consistent with the language of the claims and should encompass all legal equivalents. However, no claim is intended, nor should it be interpreted, to include subject matter that does not meet the requirements of Sections 101, 102, or 103 of the U.S. Patent Act.

Claims

1. A medical tube material having a continuous inner layer having a continuous outer layer on its surface, The inner layer contains polyolefin, The outer layer comprises a thermoplastic polymer selected from thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), and styrene-based block copolymer (SBC). The medical tube material is a medical tube material having at least 25% higher adhesive strength than a medical tube composed of a single layer of the thermoplastic polymer.

2. The medical tube material according to claim 1, wherein the inner layer is made of the polyolefin and the outer layer is made of a thermoplastic polymer.

3. The medical tubing material according to claim 2, wherein the polyolefin is made of polyethylene or polypropylene.

4. The medical tubing material according to claim 2, wherein the polyolefin consists of maleic anhydride-modified polyethylene, maleic anhydride-modified polypropylene, or a combination thereof.

5. The medical tube material according to claim 2, wherein the thermoplastic polymer is made of thermoplastic urethane.

6. The medical tube material according to any one of claims 1 to 5, wherein the thermoplastic polymer is one or more of styrene-containing thermoplastic elastomers (S-TPE), polyolefin elastomers (POE), styrene-based block copolymers (SBC), or a mixture thereof.

7. The medical tubing material according to any one of claims 1 to 6, wherein the outer layer and the inner layer do not contain polyvinyl chloride.

8. The medical tubing material according to any one of claims 1 to 7, wherein the inner layer is in direct contact with the outer layer.

9. The medical tubing material is the medical tubing material according to any one of claims 1 to 8, wherein the Shore A hardness is less than approximately 65.

10. An infusion set comprising the medical tubing material according to any one of claims 1 to 9, bonded to a medical connector by solvent bonding.

11. The infusion set according to claim 10, wherein the medical connector comprises an acrylic-based polymer, and the medical tubing material is bonded to the acrylic-based polymer.

12. The infusion set according to claim 10, wherein the inner layer is made of the polyolefin and the outer layer is made of a thermoplastic polymer.

13. The infusion set according to any one of claims 10 to 12, wherein the polyolefin is made of polyethylene or polypropylene, and the thermoplastic polymer is made of thermoplastic urethane.

14. A method for preparing an infusion set comprising the medical tubing material described in any one of claims 1 to 9, A thin layer of solvent is applied to one or both of the surfaces of the medical tubing material and the medical connector, and A method comprising, after applying the thin layer of the solvent, holding together the surface of the medical tube material and the surface of the medical connector until a seal is formed between them.

15. The method according to claim 14, wherein the solvent is applied to the outer layer of the tube material as the surface of the tube material.

16. The method according to claim 14 or 15, wherein the medical connector comprises an acrylic-based polymer.

17. The method according to any one of claims 14 to 16, wherein the solvent includes one or more alcohols, glycols, ketones, esters such as ethyl acetate, amides, sulfoxides, or hydrocarbons.

18. The method according to any one of claims 14 to 17, wherein the inner layer is made of the polyolefin and the outer layer is made of a thermoplastic polymer.

19. The method according to claim 18, wherein the polyolefin is made of polyethylene or polypropylene.

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