Multilayer medical tubing with low absorbency

Abstract

A medical tubing can have a continuous inner layer having a continuous outer layer thereon, wherein the inner layer comprises a polyolefin, such as polyethylene or polypropylene or a functionalized polyolefin. The outer layer can comprise a thermoplastic polymer, such as one or more of, or a blend comprising, thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), styrene block copolymer (SBC). Advantageously, the outer layer and / or the inner layer do not comprise polyvinyl chloride. Such a tubing can be used as a medical device, such as an infusion set.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 111,538, filed November 9, 2020, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to tubing, and more particularly to flexible medical tubing with low absorbency to the liquid medicine and components therein. Such tubing can be used in medical devices, such as tubing for administering medical fluids via infusion. Background Technology

[0004] Plastic tubing is widely used in the medical field, particularly for patient analysis and treatment procedures. However, medical tubing requires different and sometimes incompatible requirements. For example, medical tubing should be strong yet flexible or supple, kink-resistant, prevent reaction with fluids, and avoid the injection of harmful chemicals into the fluid being transported through it. However, many plastic materials with these properties tend to be inflexible. In many applications, however, medical tubing is squeezed or clamped, or used with infusion pumps that move fluid through the tubing by compressing it. This application requires the tubing to be flexible, easily squeezed, and quick to spring back. Flexible tubing with plasticizers (such as PVC) has been used in infusion kits for many years. Unfortunately, plasticized polymers (such as plasticized PVC) can be sticky and can lead to tubing blockage and tearing.

[0005] Therefore, the demand for medical conduits that can meet the diverse requirements of medical applications continues. Summary of the Invention

[0006] This subject matter relates to medical conduits comprising a continuous inner layer having a continuous outer layer thereon. Advantageously, the inner layer comprises a polyolefin, and the outer layer comprises a polymeric material different from that of the inner layer, such as a different thermoplastic polymer.

[0007] The polyolefin inner layer may comprise polyethylene or polypropylene or a functionalized polyolefin or a combination thereof, wherein the functionalized polyolefin may be selected from maleic anhydride-modified polyethylene, maleic anhydride-modified polypropylene, maleic anhydride-modified plasmon, amine-functionalized polyolefin or a combination thereof. The outer layer may comprise a thermoplastic polymer, such as one or more of the following materials, or a blend thereof, including thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), and styrene block copolymer (SBC). Advantageously, the outer and / or inner layers do not include polyvinyl chloride.

[0008] This subject matter also relates to a method for manufacturing a medical conduit by co-extruding a continuous inner layer having a continuous outer layer directly thereon, wherein the inner layer comprises a polyolefin and the outer layer comprises a thermoplastic polymer material different from the inner layer. The method may further include extruding an adhesive layer between the continuous inner and continuous outer layers. The manufactured medical conduit can be formed to be transparent to visible light.

[0009] The embodiments of the aforementioned medical conduit and method individually or in combination include one or more of the following features. In some embodiments, the medical conduit may further include an adhesive layer between a continuous inner layer and a continuous outer layer. The adhesive layer may include maleic anhydride-modified polypropylene, maleic anhydride-modified polyethylene, ethyl acetate copolymer, or combinations thereof. Alternatively, the inner layer may directly contact the outer layer. Furthermore, in other embodiments, the medical conduit may include an intermittent solvent-bonded segmented layer, such as an intermittent solvent-bonded segmented layer of thermoplastic polyurethane, directly contacting the outer layer.

[0010] From the following detailed description, those skilled in the art will readily understand the additional advantages of this subject matter, wherein only certain aspects of the subject matter are simply shown and described by way of illustration. As will be appreciated, the subject matter can have other and different configurations, and several details thereof can be modified in various other ways, all without departing from the subject matter. Therefore, the accompanying drawings and descriptions are intended to be illustrative rather than limiting in nature. Attached Figure Description

[0011] The accompanying drawings illustrate the disclosed embodiments and, together with the description, serve to explain the principles of the embodiments of this disclosure. The drawings are included to provide further understanding and are incorporated in and constitute a part of this specification. In the drawings:

[0012] Figure 1 An exemplary medical conduit with a continuous inner and outer layer is shown according to various aspects of this disclosure.

[0013] Figure 2 Another exemplary medical conduit according to various aspects of this disclosure is shown, the exemplary medical conduit including a continuous inner layer, a continuous outer layer thereon, and an adhesive layer between the continuous inner layer and the continuous outer layer.

[0014] Figure 3 Another example of a medical tubing with a double-layered polyolefin lining is shown.

[0015] Figure 4 This demonstrates how certain variables affect the extrusion of medical tubing.

[0016] Figure 5The effect of adjusting certain variables on adhesion strength during extrusion is shown. Detailed Implementation

[0017] The detailed description below describes various configurations of the subject matter and is not intended to represent the only configuration in which the subject matter can be practiced. For the purpose of providing a thorough understanding of the subject matter, the detailed description includes specific details. Therefore, dimensions are provided for certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject matter can 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 matter.

[0018] It should be understood that this disclosure includes examples of the subject matter and does not limit the scope of the appended claims. Various aspects of the subject matter are now disclosed based on specific, but not limiting, examples. The various embodiments described in this disclosure may be carried out in different ways and variations, and may conform to desired applications or implementations.

[0019] This subject matter encompasses various aspects of medical tubing capable of meeting diverse performance requirements. Medical tubing necessitates advanced material formulations and architectures to overcome the technical challenges arising from the conflicting design requirements of such tubing. For example, medical tubing should be able to bond to fittings and other components to connect the tubing, such as through solvent bonding, adhesive bonding, or mechanical connections. Furthermore, medical tubing should simultaneously prevent the absorption of medications and their components without altering the tubing itself or any active pharmaceutical ingredient (API). This requires materials that are inert in terms of drug compatibility and solvent-responsive in terms of solvent bonding capabilities—often conflicting requirements for a single material. Additionally, there is a trend towards more environmentally friendly materials and the exclusion of polyvinyl chloride (PVC). While rapid and complete recovery of the tubing is expected, it also needs to be rigid enough to allow for cutting processes for manufacturability.

[0020] The medical tubing disclosed herein can be used as a medical tubing for administering medical fluids via infusion (e.g., via an intravenous infusion assembly, gravity container, and / or infusion pump for delivering intravenously injected fluid to a patient). An assembly of tubing, valves, fittings, and needles that connects a fluid container to a patient via a vein can be referred to as an "IV kit." An infusion pump is a medical device that can be used to administer intravenously (IV) fluids. Such assemblies, containers, and pumps employ tubing coupled with one or more medical connectors, and the tubing of this disclosure is useful for this purpose.

[0021] In some aspects, this subject matter relates to medical tubing comprising a continuous inner layer having a continuous outer layer thereon. Advantageously, the inner layer comprises a polyolefin with low absorption properties, such that the polyolefin inner layer prevents absorption of the drug solution and / or components therein or prevents interference with any active pharmaceutical ingredient (API) delivered through the tubing. Furthermore, the polyolefin inner layer prevents alteration of the tubing itself due to the delivery of medical fluids therethrough.

[0022] In some embodiments, the continuous inner layer may include 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 plastide, or a combination thereof. Such a functionalized polyolefin facilitates interlayer adhesion between the inner and outer layers.

[0023] The outer layer may include a polymeric material different from the inner layer, allowing the outer surface of the conduit to have properties different from those of the inner layer material. For example, the outer layer may include a thermoplastic polymer or blends thereof, such as one or more of the following materials or blends including thermoplastic polyurethane (TPU), thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), and styrene block copolymer (SBC). The thermoplastic polymer used as the outer layer may be further blended with other polymeric components and / or additives. For example, the thermoplastic polymer used as the outer layer may be further blended with adhesion promoters (such as acrylic TPE) or polar functionalized polyolefins (e.g., up to 15 wt% or more of the blend), tackifiers, and clarifying agents (e.g., up to 10 wt% of the blend). Many thermoplastic polymers have advantageous properties for the outer layer of medical conduits, such as thermoplastic polyurethane (TPU), which can be used for solvent bonding of the outer layer of the conduit. Optionally, or in combination, many thermoplastic polymers advantageously improve the flexibility of pipes.

[0024] In some aspects of the medical conduit disclosed herein, an adhesive layer may be included between a continuous inner layer and a continuous outer layer.

[0025] Advantageously, the medical tubing disclosed herein does not include polyvinyl chloride (PVC). That is, the outer and / or inner and / or adhesive layers (if present) do not include PVC.

[0026] In some aspects, the medical tubing of this disclosure may have a Shore A hardness greater than or less than about 85. For medical tubing applications, a Shore A hardness greater than about 85 is generally considered hard. Pump tubing typically uses softer tubing with a Shore A hardness less than about 65 (e.g., 55 or less).

[0027] The following medical tubing structures and material formulations can meet many of the requirements for IV kits and other medical tubing requirements.

[0028] Table 1. Solvent-binding, low-absorption polyolefin-lined TPU medical tubing structures

[0029]

[0030] (1) Exxelor PE1040 is a maleic anhydride modified HDPE.

[0031] (2) TecnoBond PE-LMP is a maleic anhydride PE

[0032] (3) Toyo-Tac M-100 is a maleic anhydride PP

[0033] (4) VA1840 is a maleic anhydride-modified plastic.

[0034] (5) Ellastollan 1180A is an ether-based thermoplastic polyurethane.

[0035] (6) Tecothane TT1095A TPU is Shore A 95 TPU, which can meet the different needs of small diameter pipes.

[0036] As shown in Table 1, the continuous inner layer may comprise an amine-functionalized polyolefin or a maleic anhydride-modified polyolefin. This amine-functionalized polyolefin can be prepared by reactive extrusion by combining and reacting a maleic anhydride-modified polyolefin (e.g., selected from 1, 2, 3, and 4 in Table 1 above) with a polyetheramine. This formulation or the maleic anhydride-functionalized polyolefin allows for increased compatibility of the polyolefin (a nonpolar, low surface energy material) with more polar material groups. The pipe architecture in Table 1 requires good interlayer adhesion between polar and nonpolar material groups; therefore, this customization should increase the adhesion from the inner layer to the outer layer.

[0037] The double-layer polyolefin-lined TPU medical tubing structure provided in Table 1 offers several advantages, including: eliminating the need for a three-layer process; increased production line speed / output compared to a three-layer process; for example, co-extrusion operations should be faster and simpler than with a three-layer process; lower standard costs compared to a three-layer process; and better adhesion of the inner layer due to compatibility gains through the functionalization of the inner layer, compared to the poor adhesion of unmodified polyolefins. The functionalized polyolefin inner layer, however, results in lower drug absorption performance.

[0038] Furthermore, in some embodiments, the continuous inner layer can be relatively thinner than the continuous outer layer, which will result in the conduit having similar overall properties to the TPU layer. Additionally, the ether-based TPU layer provides better solvent binding, and the selection of an aliphatic backbone provides better color stability.

[0039] Figure 1 An example of a medical tubing with a double-layer polyolefin lining is shown. This structure can be used with the polymeric materials listed in Table 1 above to provide a solvent-binding, low-absorption double-layer polyolefin-lined TPU medical tubing. As shown, the double-layer medical tubing comprises an inner layer (10) and an outer layer (12) directly on the inner layer.

[0040] For use in applications including IV kits and / or infusion pumps, the tubing of this disclosure may have an inner diameter for fluid flow, ranging from about 1.5 mm to about 6 mm, for example, from 2 mm to 4 mm. The overall sidewall thickness may range from about 0.2 mm to about 1 mm, for example, from 0.4 mm to 0.6 mm. In some aspects of this disclosure, the outer layer may include 10% to 90% of the sidewall thickness, and the inner layer may include 90% to 10% of the sidewall thickness. In one embodiment, the outer layer may have a thickness of about 0.01 mm to about 0.5 mm (e.g., from about 0.05 mm to about 0.2 mm), and the inner layer may have a thickness of about 0.1 mm to about 0.8 mm (e.g., from about 0.5 mm to about 0.5 mm).

[0041] Table 2 below is another example of a medical tubing structure that can be used in accordance with this disclosure.

[0042] Table 2. Solvent-bondable, low-absorption PE-lined TPU pipes with adhesive layers.

[0043]

[0044] (1) TecnoBond PP / TLA is a maleic anhydride-modified random block PP copolymer.

[0045] (2) Random PP copolymer extrusion grade

[0046] (3) LDPE

[0047] (4) Low-density polyethylene EC800 is a general-purpose low-density formulation for extrusion coating applications.

[0048] (5) EVA copolymer

[0049] (6) Other alternatives include ReZilok Rx as a linear low-density polyethylene grafted with maleic anhydride.

[0050] As shown in Table 2, medical tubing may include a continuous inner layer, a continuous outer layer on the continuous inner layer, and an adhesive layer between the continuous inner and outer layers. As indicated in Table 2, the inner layer may include a polyolefin, such as polypropylene or polyethylene (e.g., linear low-density polyethylene, LDPE). The outer layer may include thermoplastic polyurethane (TPU), which can be used for solvent bonding of the outer layer of the tubing. Medical tubing may also include an adhesive layer between the continuous inner and outer layers. This adhesive layer may include functionalized polyolefins, such as maleic anhydride-modified polypropylene, maleic anhydride-modified polyethylene, or other adhesive layer polymers (e.g., ethyl acetate copolymer (EVA copolymer)) or combinations thereof.

[0051] The three-layer polyolefin-lined TPU medical tubing structure provided in Table 2 has several advantages, including: compatible skeleton selection (matching PP with PP-based TPO or POP, and PE with PE-based TPO or POE) enables compatibility without requiring more expensive functionalized polymers, including the low drug absorption performance of the PP or PE-based inner layer.

[0052] Furthermore, in some embodiments, the continuous inner layer can be relatively thinner than the continuous outer layer, which will result in the conduit having similar overall properties to the TPU layer. Additionally, the ether-based TPU layer provides better solvent binding, and the selection of an aliphatic backbone provides better color stability.

[0053] Figure 2 An example of a three-layer polyolefin-lined medical tubing is shown. This structure can be used with the polymeric materials listed in Table 2 above to provide a solvent-bondable, low-absorption polyolefin-lined TPU medical tubing with an adhesive layer. As shown, the three-layer medical tubing includes an inner layer (20), an outer layer (22), and an adhesive layer (24) between the inner layer (20) and the outer layer (22) and in direct contact with the inner and outer layers.

[0054] For use in applications including IV kits and / or infusion pumps, the tubing of this disclosure may have an inner diameter for fluid flow, ranging from about 1.5 mm to about 6 mm, for example, from 2 mm to 4 mm. The overall sidewall thickness may range from about 0.2 mm to about 1 mm, for example, from 0.4 mm to 0.6 mm. In some aspects of this disclosure, the outer layer may include 10% to 90% of the sidewall thickness, and the inner layer may include 90% to 10% of the sidewall thickness. In one embodiment, the outer layer may have a thickness of about 0.1 mm to about 0.8 mm (e.g., from about 0.5 mm to about 0.5 mm), and the inner layer may have a thickness of about 0.01 mm to about 0.5 mm (e.g., from about 0.05 mm to about 0.2 mm).

[0055] Figure 3Another example of a double-layered polyolefin-lined medical tubing is shown. This structure can be used to provide medical tubing with a solvent-bondable, low-absorption polyolefin lining. As shown, the medical tubing includes a continuous inner polyolefin layer (30) and a continuous outer layer (34). For this example, the medical tubing further includes discontinuous solvent-bondable segmented layers (32) in direct contact with the outer layer 34. The discontinuous solvent-bondable segmented layers may include thermoplastic polyurethanes, such as TPU with good adhesion.

[0056] Table 3 below is another example of a medical tubing structure that can be used according to this disclosure.

[0057] Table 3. Low-absorption PE-lined TPO double-walled pipes

[0058] outer layer Inner layer Engage 8003(1) LDPE, HDPE, and other vinyl polyolefins Engage 8452(2) LDPE, HDPE, and other vinyl polyolefins Versify 3300(3) Random PP copolymer, sterilization grade Vistamaxx 3020(4) Random PP copolymer sterilization grade

[0059] (1) Ethylene-octene polyolefin elastomer (POE)

[0060] (2) Ethylene-butene polyolefin elastomer (POE)

[0061] (3) POP

[0062] (4) Propylene elastomer with i-PP repeating units of random ethylene.

[0063] As shown in Table 3 above, medical tubing may include a continuous inner layer and a continuous outer layer directly thereon. The continuous inner layer may include a nonfunctionalized polyolefin, such as polyethylene (e.g., LDPE, HDPE) or polypropylene. The continuous outer layer may include a thermoplastic polymer, such as a polyolefin elastomer (POE), for example, ethylene-octene polyolefin elastomer, ethylene-butene polyolefin elastomer, polyolefin plastomer (POP), propylene elastomer, and other thermoplastic polymers or blends thereof.

[0064] Many thermoplastic polymers (including thermoplastic elastomers (TPEs) and thermoplastic olefins used for the outer layer of the medical tubing of this disclosure) can be compounded with polyolefins to optimize cost, increase crystallinity, increase mechanical strength, increase operating range (i.e., environmental stability and shelf life), and increase material compatibility (i.e., interlayer adhesion with the inner layer). Below are some different customizations that can overcome certain shortcomings of s-TPE and TPO thermoplastic polymers.

[0065] Custom-made styrene block copolymer (SBC) compounds: SBC grades are useful due to their flexibility and solvent responsiveness (i.e., binding properties). However, some of our experiments show that kink resistance is inferior to other polymer types in styrene-based TPEs. Furthermore, some SBC grades lack high-temperature resistance, as observed by their low softening points. Similarly, POP and POE grades (e.g., Engage reactors) result in TPO lacking high-temperature resistance, as observed by their low softening points. Tables 4-5 provide examples of thermoplastic polymer blends that can be used as continuous outer layers for medical tubing according to this disclosure.

[0066] SBC blends with random PP copolymers: SBC blends with random PP copolymers produce solvent-bonded, anti-kink materials for use in the pipe itself (as-in) or for solvent-bonded layers. The blend ratio can vary from 5% to 95% of the olefin component (vinyl or propylene) to allow for further refinement based on transparency requirements. These blends may also contain up to 15 wt% of polar functionalized polyolefins or adhesion promoters (such as acrylic TPEs). When modifications to the melt flow rheology and transparency of the pipe are required, up to 10 wt% of thickeners and clarifying agents, as well as polymer processing aids, are typically added for these types of compounds. Various processing variables can affect the pipe's transparency and its mechanical properties.

[0067] TPO blends containing random PP copolymers, polyolefins, or heat-resistant TPOs (such as olefin block copolymers). The blending ratio can vary from 5% to 95% of the olefin component (vinyl or propylene-based), which can be adjusted based on transparency requirements. These blends may also contain up to 15 wt% of polar functionalized polyolefins or adhesion promoters (such as acrylic TPEs). When modifications to the melt flow rheology and transparency of the pipe are required, up to 10 wt% (of the blend) of thickeners, clarifying agents, and polymer processing aids are typically added for these types of compounds. Various processing variables can affect the pipe's transparency and its mechanical properties.

[0068] Table 4. Examples of Customized TPE Blends

[0069]

[0070]

[0071] Table 5. Other examples of custom TPE blends

[0072]

[0073] Infuse 9010 olefin block copolymer (OBC)

[0074] Engage 8003, Engage 7256 and Engage 8452 polyolefin elastomers

[0075] Ineos 4G80 styrene-butadiene block copolymer

[0076] For example, the thermoplastic polymer medical tubing structure with a double-layer polyolefin lining provided in Table 3 has several advantages, including: no need for a three-layer process; increased processing cycle time compared to a three-layer process; for example, co-extrusion operation should be faster and simpler than a three-layer process; lower expected cost compared to a three-layer process; good adhesion of the layers due to compatibility with the inner layer; and lower drug absorption performance when a non-functionalized polyolefin inner layer is included.

[0077] The medical tubing of this disclosure can be manufactured by extrusion. For example, the medical tubing according to this disclosure can be co-extruded into a continuous inner layer having a continuous outer layer on top of a continuous inner layer, wherein the inner layer comprises a polyolefin and the outer layer comprises a polymeric material different from the inner layer. Preferably, it is manufactured as a clear, for example, visible-light transparent medical tubing. Extruding clear tubing presents a number of challenges; the following processing variables can create differences between clear and blurred tubing. Clarity is affected by die temperature, tooling design, and preform ventilation.

[0078] Die temperature: (a) Die temperature affects pipe transparency through its interaction with pipe surface finish. Lowering the die temperature near the end of the die will cause the outermost layer (surface) of the pipe to “stick” to the tool during extrusion. Sticking will result in a velocity difference in the polymer melt from the inside out, and cause micro-deformation (“tears”) on the surface. These cracks result in an opaque or “frosted” appearance for the pipe. (b) Conversely, increasing the die temperature will help make the pipe more transparent by reducing the velocity difference in the polymer melt from the inside out, resulting in fewer micro-deformations on the surface.

[0079] Tool Design: (a) The effect of extrusion tooling on surface finish is similar to that of die temperature. By reducing friction between the tooling material and the polymer melt, the polymer melt velocity will be more consistent throughout the preform. This reduction in friction is achieved through tool finishing or coating.

[0080] Preform Ventilation: (a) The last process parameter that may affect pipe transparency is the location of the preform vent. The purpose of the vent is to expel any fumes from the preform as it is extruded, and the vent is typically placed directly above the preform. Vents with large openings can be placed further away from the preform to capture any fumes, but small, serpentine vents must be placed within a few inches of the preform. If the vent is placed too close to the preform, the preform will be affected by air intake, and this will change the surface finish of the pipe, potentially resulting in an opaque / frosty finish. (b) This is similar to a frosted extrusion process, where cold air is blown directly onto the preform during extrusion.

[0081] Figure 4 This illustrates how the extrusion process affects objects 1 and 2 below, and Figure 5 This shows the effect of adjusting certain variables on adhesion strength during extrusion.

[0082] It should be understood that any particular order or hierarchy of blocks in the disclosed process is illustrative. Based on design or implementation preferences, it should be understood that the particular order or hierarchy of blocks in the process may be rearranged, or all blocks shown may be executed. In some implementations, any blocks may be executed concurrently.

[0083] 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 matter, and the subject matter is not limited to these examples. Various modifications to these aspects will be apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0084] Unless otherwise specified, references to singular elements are not intended to mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Titles and subtitles, if any, are used for convenience only and do not limit the invention.

[0085] In this document, the term “exemplary” is used to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as being better or more advantageous than other aspects or designs. In one aspect, the various alternative configurations and operations described herein may be considered at least equivalent.

[0086] As used herein, the phrase “at least one…” preceding a series of terms, separated by the word “or,” modifies the entire list of entries as a whole, not each term in the list of entries. The phrase “at least one…” does not require the selection of at least one term; rather, it allows for the inclusion of at least one of any term, and / or at least one of any combination of terms, and / or at least one of each term. For example, the phrase “at least one of A, B, or C” can refer to: only A, only B, or only C; or any combination of A, B, and C.

[0087] For example, phrases such as "aspect" do not imply that such an aspect is necessary for the subject matter art, or that such an aspect can be applied to all configurations of the subject matter art. Disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. For example, phrases such as "aspect" may refer to one or more aspects, and vice versa. For example, phrases such as "embodiment" do not imply that such an embodiment is necessary for the subject matter art, or that such an embodiment can be applied to all configurations of the subject matter art. Disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. For example, phrases such as "embodiment" may refer to one or more embodiments, and vice versa. For example, phrases such as "configuration" do not imply that such a configuration is necessary for the subject matter art, or that such a configuration can be applied to all configurations of the subject matter art. Disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. For example, phrases such as "configuration" may refer to one or more configurations, and vice versa.

[0088] In one aspect, unless otherwise stated, all measurements, numerical values, ratings, positions, grades, sizes, and other specifications set forth in this specification (including in the claims below) are approximate, not precise. In one aspect, they are intended to have a reasonable range consistent with the function they pertain to and with the custom of the art to which they belong.

[0089] It should be understood that the specific order or hierarchy of the disclosed steps, operations, or processes is an illustrative example. Based on design preferences, it should be understood that the specific order or hierarchy of steps, operations, or processes can be rearranged. Some steps, operations, or processes can be performed simultaneously. Some or all steps, operations, or processes can be performed automatically without user intervention. The appended method claims (if any) present the elements of various steps, operations, or processes in a sample order and are not intended to limit one to the specific order or hierarchy presented.

[0090] All structural and functional equivalents of elements throughout the various aspects described herein, known or to be known by one of ordinary skill in the art, are expressly incorporated herein by reference and are intended to be covered by the claims. Furthermore, nothing disclosed herein is intended to be exclusive to the public, whether or not such disclosure is expressly stated in the claims. No claim element may be construed under 35 U.S.C. § 112(f) unless it is expressly stated using the phrase “means for…” or, in the case of a method claim, using the phrase “steps for…”. Furthermore, with regard to the use of the terms “comprising,” “having,” or similar terms, such terms are intended to be included in a manner similar to the term “comprising,” as interpreted when “comprising” is used as a transitional word in a claim.

[0091] The title, background art, summary of the invention, brief description of the drawings, and abstract of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples rather than limiting descriptions. It should be understood upon filing this application that they are not intended to limit the scope or meaning of the claims. Furthermore, it will be apparent from the detailed description that it provides illustrative examples and that various features are grouped together in various embodiments for the purpose of simplification. The method of disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than expressly stated in each claim. Rather, as reflected in the following claims, the subject matter of the invention lies in all features of fewer than those in a single disclosed configuration or operation. The following claims are hereby incorporated into the detailed description, wherein each claim stands independently as a separately claimed subject matter.

[0092] The claims are not intended to be limited to the aspects described herein, but rather conform to the full scope consistent with the language claims and cover all legal equivalents. Nevertheless, none of the claims are intended to include subject matter that fails to meet the requirements of Sections 101, 102, or 103 of Title 35 of the United States Code, nor should they be interpreted in this manner.

Claims

1. A medical conduit comprising a continuous inner layer, thereon having a continuous outer layer and discontinuous solvent-bonded segmented layers in direct contact with the continuous outer layer. in, The solvent-binding segmented layer is disposed only on a portion of the length of the medical tubing, and the discontinuous solvent-binding segmented layer is configured to bond the medical tubing to a connector. The inner layer comprises a functionalized polyolefin, and the outer layer comprises a thermoplastic polymer. The inner layer is made of a different material than the outer layer. The functionalized polyolefin is selected from maleic anhydride-modified polyethylene, maleic anhydride-modified polypropylene, maleic anhydride-modified plastide, amine-functionalized polyolefin, or a combination thereof. The medical tubing does not include polyvinyl chloride.

2. The medical conduit according to claim 1, wherein, The amine-functionalized polyolefin is formed by reacting a polyetheramine with a maleic anhydride-modified polyolefin.

3. The medical conduit according to claim 1, wherein, The medical tubing has a Shore A hardness of less than 65.

4. The medical conduit according to claim 1, wherein, The thermoplastic polymer includes ether-based thermoplastic polyurethane.

5. The medical conduit according to claim 1, wherein, The inner layer comprises polyethylene or polypropylene.

6. The medical conduit according to claim 1, wherein, The outer layer comprises one or more of the following materials, or a blend of the following materials: thermoplastic olefin (TPO), thermoplastic elastomer (TPE), styrene-containing thermoplastic elastomer (S-TPE), polyolefin elastomer (POE), and styrene block copolymer (SBC).

7. The medical conduit according to claim 1, wherein, The thermoplastic polymer is a blend that includes one or more adhesion promoters and clarifying agents.

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

9. The medical conduit according to any one of claims 1-7, wherein, The medical conduit further includes an adhesive layer between the continuous inner layer and the continuous outer layer.

10. The medical conduit according to claim 9, wherein, The adhesive layer comprises maleic anhydride-modified polypropylene, maleic anhydride-modified polyethylene, ethyl acetate copolymer, or a combination thereof.

11. The medical conduit according to any one of claims 1-7, wherein, The medical tubing has a Shore A hardness of 55 or lower.

12. A method of manufacturing a medical tubing, the method comprising co-extruding a continuous inner layer having a continuous outer layer thereon as described in claim 1.

13. The method according to claim 12, wherein, The medical tubing is transparent to visible light.

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