Continuous tube with alternating compositions for medical devices

Abstract

To provide a continuous tube having alternating compositions capable of meeting the requirements for medical use.SOLUTION: The tube includes a first segment having a first polymer composition, a second segment having a second polymer composition, and a third segment having a third polymer composition, where the first segment and the third segment are joined to the second segment at opposite ends of the second segment. The first segment and the second segment are integrally joined by a transition segment that includes a mixture of the first polymer composition and the second polymer composition, and the third segment and the second segment are integrally joined by a transition segment that includes a mixture of the third polymer composition and the second polymer composition. The polymers of the first polymer composition and the second polymer composition are different. The Shore A hardness of the first segment and the third segment is greater than the Shore A hardness of the second segment.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present disclosure relates generally to tubing, and more particularly to continuous tubing having alternating compositions along its length, which can be used for medical devices such as tubing for administering medical fluids by infusion. [Background technology]

[0002] Plastic tubing is widely used in the medical field, especially in patient analysis and treatment procedures. However, medical tubing has different, sometimes conflicting, requirements. For example, medical tubing must be inert and avoid contamination of the fluids transported through it. However, many plastic materials with such properties tend to lack flexibility. However, in many applications, medical tubing is pinched, clamped, or used by infusion pumps, which move fluids through the tubing by compressing the tubing. Such applications require the tubing to be flexible. However, soft tubing, such as silicone, is difficult to bond to other materials, such as polycarbonate, PMMA, acrylic terpolymers, polyesters, copolyesters, acrylonitrile-butadiene-styrene, and methacrylonitrile-butadiene-styrene-based connectors. Summary of the Invention [Problem to be solved by the invention]

[0003] To address the various demands on medical tubing, such tubing has been constructed with multiple layers of different polymeric materials to alter the tubing's properties. However, tubing constructed from dissimilar materials is susceptible to delamination. Mechanical and frictional bonding of flexible tubing has also been used, but such mechanisms are limited to low tensile forces, and the tubing may slip through the mechanical retention mechanism. Therefore, there is a continuing need for medical tubing that can address the diverse demands of medical applications. [Means for solving the problem]

[0004] Aspects of the present technology relate to continuous tubes having alternating compositions along their length. Such continuous tubes can include at least a first segment having a first composition along their length and at least a second segment having a second composition along their length, where the first composition is different from the second composition. The tube can further include third, fourth, etc. segments having the same or different compositions. The segments are integrally joined and can be formed by sequential extrusion, such as extruding the first composition followed by the second composition.

[0005] The subject technology also relates to a method for forming a continuous tube having alternating compositions along its length. The method can include extruding a first segment of the tube along its length from a first composition using a first pump on an extrusion line, followed by extruding a second segment of the tube along its length from a second composition using a second pump on the extrusion line. Advantageously, the first and second compositions are different, and the first and second segments are integrally joined by sequentially extruding the first and second compositions onto each segment. The method can also include extruding a third segment of the tube along its length from a third composition using a third pump on the extrusion line, thereby integrally joining the second and third segments. In some embodiments, the method further includes forming a transition segment between adjacent segments, e.g., forming a transition segment between the first and second segments. The transition segment comprises a mixture of the respective compositions forming the adjacent segments.

[0006] Embodiments of the aforementioned continuous tube and method may include one or more of the following features, individually or in combination. In some embodiments, the first composition may differ from the second composition such that the properties of the first and second segments differ by at least 5%. For example, the first and second segments may have different Shore A hardness levels that differ by at least 5%. Such differences in properties may be achieved by varying the polymeric materials in the first and second compositions and / or by varying the amount or type of additives between the first and second compositions. For example, the first segment may include a polyvinyl chloride composition containing an amount of plasticizer, and the second segment may include a polyvinyl chloride composition containing an amount of plasticizer, the amount of plasticizer in the first segment being less than the amount of plasticizer in the second segment. In other embodiments, the first segment, and optionally the third segment, may have a Shore A hardness of at least about 70, and the second segment may have a Shore A hardness of about 60 or less. In yet another embodiment, the first composition comprises a first polymer and the second composition comprises a second polymer, and the first polymer is different from the second polymer. In other embodiments, the composition of the first segment, and optionally the third segment, can comprise a non-hydrogenated styrenic TPE, and the composition of the second segment can comprise a hydrogenated styrenic TPE.

[0007] Additional advantages of the subject technology will become readily apparent to those skilled in the art from the following detailed description, wherein, by way of example only, certain aspects of the subject technology are shown and described. As will be understood, the subject technology is capable of other and different configurations, and its several details can be modified in various other respects, all without departing from the subject technology. Accordingly, the drawings and description should be regarded as illustrative in nature, and not as restrictive.

[0008] The accompanying drawings, which are included to provide a further understanding and are incorporated in and constitute a part of this specification, illustrate disclosed embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. [Brief explanation of the drawings]

[0009] [Figure 1] 1 shows an exemplary continuous tube having alternating composition along its length, occurring in hard-soft-hard segments along the length of the tube. [Figure 2] 1 shows another exemplary continuous tube with alternating composition along its length, occurring in hard-soft-hard segments along its length. In this example, the tube is stepped down to a smaller outer diameter at each end of the tube, which may help determine placement of the ends within a pocket joint of a connector. [Figure 3] 1 shows an exemplary continuous tube having alternating compositions along its length partially inserted into a pocket of an exemplary connector. [Figure 4] 1 shows another exemplary continuous tube having alternating compositions along its length. DETAILED DESCRIPTION OF THE INVENTION

[0010] 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 instances, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0011] It should be understood that this disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology are now disclosed according to specific, but non-limiting, examples. The various embodiments described in this disclosure can be implemented in different ways and with modifications according to a desired application or implementation.

[0012] Aspects of the subject technology relate to a continuous tube having alternating compositions along its length, and in particular, a continuous tube having at least a first segment along its length formed from a first composition and at least a second segment along its length formed from a second composition, where the first composition is different from the second composition, thus forming an AB segmented continuous tube, where "A" and "B" represent segments formed from different compositions. Advantageously, the first and second segments are integrally joined to one another along the length of the tube, with or without a transition segment.

[0013] In certain embodiments of the present disclosure, a continuous tube having alternating first and second segments can further include other segments (e.g., a third segment along the length of the tube integrally joined to the second segment). The third segment can be formed from a third composition such that the first and third segments are composed of different materials, thus forming an ABC-segmented continuous tube. Alternatively, the first and third segments can be formed from the same composition, thus forming an ABA-segmented continuous tube. Advantageously, adjacent segments of different compositions are integrally joined, e.g., the first and second segments are integrally joined to each other, the second and third segments are integrally joined to each other, and so on, with or without a transition segment.

[0014] In certain embodiments of the present disclosure, different compositions (e.g., first and second compositions) form segments that can have properties (e.g., hardness, flexibility, connectivity) that differ by at least 5% (e.g., at least 10%). For example, adjacent segments can have different hardness levels by at least 4 units. Alternatively, adjacent first and second segments can have Shore A hardness levels that differ by at least 5%. In some embodiments of the present disclosure, a first segment of a continuous tubing can be high stiffness or rigid, and an integrally joined second segment can be flexible. Medical tubing for IV sets, for example, having a Shore A hardness greater than about 85 is considered high stiffness and is used for certain applications, while tubing used for pumping medical solutions generally uses softer tubing with a Shore A hardness of, for example, about 60 or less. In some embodiments of the present disclosure, a hard-soft segment can be integrally joined, where the hard segment is formed from a first composition and the soft segment is formed from a second composition. The first and second compositions can contain the same or different polymers. When the first and second compositions contain the same polymer, such as polyvinyl chloride, the first and second compositions can contain different amounts or types of additives, such as less or more plasticizer, thereby forming different compositions. In another embodiment of the present disclosure, the first and second segments can have the same or similar hardness levels but contain different polymers.

[0015] The alternating continuous tubes of the present disclosure can be produced by alternately extruding different compositions on the same extrusion line. For example, an extrusion line having a first extrusion pump supplying a first composition can be activated to extrude a first segment of tube made with the first composition, and after a certain length, the first pump can be stopped. A second pump supplying a second composition can then be activated to extrude a second segment of tube containing the second composition for a specific length, and then the second pump can be stopped. This process can be repeated by activating and deactivating the first and second pumps with the first and second compositions, respectively, to form a tube having alternating first and second segments containing the first and second compositions. The alternating tubes formed by alternating extrusion can be cut within the first or second segment to form tubes having ABA or BAB segments. Additional extrusion pumps supplying yet different compositions can also be included on the same extrusion line to form third, fourth, etc. segments containing third, fourth, etc. compositions in any order. Tubing produced on alternating polymer extrusion lines may have a material transition section, for example, where different compositions are mixed and the mixture forms a transition segment between the first and second segments. A transition segment may result from a small amount of one composition remaining in the dead space between the pump and the die exit area on the extrusion line when one of the composition pumps (e.g., the first pump) stops and another pump (e.g., the second pump) starts. This material transition section can be minimized by reversing the rotation of the pump before stopping it. Alternatively, or in addition, transition segments between segments (e.g., between the first and second segments) can be minimized by evacuating the composition in the dead space with a bale.

[0016] Thus, in one aspect of the present disclosure, a method for forming a tube having alternating compositions along its length includes extruding a first segment of the tube along its length from a first composition with a first pump on an extrusion line, followed by extruding a second segment of the tube along its length from a second composition with a second pump on the extrusion line. By sequentially extruding the first and second segments, the first and second segments are integrally bonded together. The method can also include extruding a third segment of the tube along its length from a third composition with a third pump on the extrusion line, thereby integrally bonding the second and third segments together. The first, second, and third compositions can be different, resulting in segments having properties (e.g., hardness) that differ by at least 5% (e.g., at least 10%).

[0017] The alternating extrusion technique used to prepare tubing with alternating compositions along its length advantageously allows for essentially seamless transitions between various segments because the segments are integrally joined. Thus, the transition between segments is as strong as the material composition itself. Additionally, the method includes forming a transition segment between adjacent segments (e.g., between a first segment and a second segment), where the transition segment can comprise a mixture of the first and second compositions. Alternatively, such transition segments can be minimized by reversing the pump associated with a particular segment.

[0018] Selecting different compositions for different segments of a continuous tube that are somewhat miscible facilitates integration of the compositions along the tube and resists separation of the first, second, etc. segments of the tube made from such different compositions. Hansen solubility parameters and / or miscibility calculations from the literature can be used as a guide for selecting appropriately miscible materials and their compositions. Such information can be found, for example, in White, James L. Kim, and Kwang-Jea (2008), "Thermoplastic and Rubber Compounds - Technology and Physical Chemistry - 5.4 Miscible Polymer Blends," (pp. 157, 158, 159), Hansen Publishers.

[0019] For example, compositions that can be subsequently extruded as the first composition include styrene-based thermoplastics. Thermoplastic elastomer (TPE), non-hydrogenated styrene-based TPE, ester-based polyurethane, acetal Thermoplastic resins such as terephthalate polyurethanes, carbonate polyurethanes, and thermoplastic olefins (TPO) or combinations thereof, low density polyethylene (LDPE) or polypropylene TPO blends with pyrene (PP), polyether block amide, copolyester elastomer The second polymer includes a vinyl ester, ... Compositions that can be extruded in turn include, for example, styrene-based TPEs, non-hydrogen oxidized and hydrogenated styrenic TPEs and their blends, ester-based polyurethanes, Ether-based polyurethane, carbonate-based polyurethane thermoplastic resin, EVA, thermoplastic EVA blends with resistant polyurethane (TPU), polypropylene blends with LDPE, TPO, PVC, etc. Ethylene vinyl acetate (EVA) blends, and combinations thereof. Thermoplastic olefins include propylene elastomers, olefin block copolymers, Includes propylene-ethylene copolymers and ethylene-octane copolymers. Styrene-based TP E is hydrogenated polyisoprene polymer (styrene-ethylene propylene styrene (SE PS), styrene-ethylene propylene (SEP), hydrogenated polybutadiene polymers - (styrene-ethylenebutylene-styrene (SEBS), styrene-ethylenebutylene (SEB), Styrene-Butadiene-Styrene (SBS), Styrene-Isoprene-Styrene Styrene-isoprene-butadiene-styrene (SIS), Styrene-isoprene-butadiene-styrene (SIBS), etc.), hydrogen Modified polyisoprene / butadiene polymer (styrene-ethylene ethylene propylene-styrene) SEEPS, etc.), and their combination with polyolefins (e.g., polypropylene) The first, second, and optionally third compositions may contain additives such as plasticizers. Any additives may be included.

[0020] FIG. 1 shows an example of a continuous tube having alternating compositions along its length as an ABA segmented continuous tube. As shown, the continuous tube 100 includes first and third segments (110, 130, respectively) at both ends of the tube 100 and a middle segment 120. The first and third segments (110, 130, respectively) can be extruded from a first composition and integrally joined to the middle segment 120, which can be extruded from a second composition. In this example, the end segments (110 and 130) include a composition that provides a hard segment, while the middle segment (120) is composed of a composition that forms a relatively soft segment. For example, the first and third segments can have a Shore A hardness greater than about 85, while the second segment can have a Shore A hardness less than about 80. For medical tubing applications, a Shore A hardness greater than about 85 is typically considered hard. Pump tubing typically uses softer tubing, typically about 55 Shore A. Tubing with a Shore A of over 85 is considered high stiffness. In this example, the end segments 110 and 130 are relatively shorter than the intermediate segment 120; for example, the end segments (110, 130) have lengths of about 2 inches (about 50.8 mm) or less (e.g., between about 0.25 inches (6.35 mm) and about 1.5 inches (38.1 mm)). Such ABA-segmented tubing can be used to solvent-bond the A segments to connectors, such as the pocket joints of connectors made of high-stiffness acrylic materials. In this way, tubing made of a material that is difficult to solvent-bond (e.g., segment 120) can be solvent-bonded to the connectors using end segments (110, 130), which can be made of a material that is more easily solvent-bonded.

[0021] FIG. 2 illustrates another exemplary continuous tube having alternating compositions along its length, manifesting in hard-soft-hard segments along its length. As shown, continuous tube 200 includes first and third segments (210, 230, respectively) at either end of tube 200 and an intermediate segment 220. In this example, the end segments (210 and 230) include a composition that provides a hard segment, while intermediate segment 220 is comprised of a composition that forms a relatively soft segment. The first and third segments (210, 230, respectively) can be extruded from a first composition and integrally joined to intermediate segment 220, which can be extruded from a second composition. In this example, tube 200 includes a transition segment 215 between first segment 210 and second segment 220 and a transition segment 225 between second segment 220 and third segment 230, which can be formed by the alternating extrusion techniques described herein. The transition segments (215, 225) have a length of less than approximately 15 mm. The first segment 210 includes a first diameter segment (212) and a stepped (smaller) diameter segment (214), and the third segment 230 includes a first diameter segment (232) and a stepped (smaller) diameter segment (234). The stepped (smaller) diameter segments (214, 234) can be inserted into a pocket joint of a connector, such as a connector including a high-rigidity acrylic material. This configuration can also be used to visually inspect whether the joint is fully inserted.

[0022] 3 shows an exemplary continuous tube 200 having a first segment with a stepped (smaller) diameter segment (214) partially inserted into a pocket (352) of an exemplary connector 350. If the tube is not fully inserted into the connector's pocket when mating the tube to the connector, or if the tube must be forced out of the pocket due to lack of proper adhesion, for example, with a solvent, a gap (360) will be found just outside the entrance to the mating pocket. Control measures can be taken to monitor for the presence of gaps, and if a gap of a certain predetermined length is found, the joint can be considered faulty.

[0023] For example, the continuous tubing of the present disclosure, as illustrated in Figures 1-3, can be used as medical tubing for administering medical fluids by infusion, such as through an intravenous assembly, gravity container, and / or an infusion pump for transporting intravenous fluids to a patient. The assembly of tubing, valves, fittings, and needles that connects a fluid container to a patient intravenously is sometimes referred to as an "IV set." An infusion pump is a medical device that can be used to administer intravenous (IV) fluids. Such assemblies, containers, and pumps use tubing coupled to one or more medical connectors, and the tubing of the present disclosure is useful as such.

[0024] In certain embodiments, the continuous tube can include first and third segments (e.g., end segments of an ABA tube) formed from an acrylic TPE blend, a non-hydrogenated styrenic thermoplastic elastomer, a thermoplastic polyurethane, PVC, and a second (e.g., middle) segment formed from a hydrogenated styrenic thermoplastic elastomer, a hydrogenated styrenic thermoplastic elastomer blend with PP, a blend of hydrogenated and non-hydrogenated styrenic thermoplastic elastomers, polyvinyl chloride, a thermoplastic polyurethane, a thermoplastic silicone-polyether-urethane.

[0025] Alternating continuous tubes designed with appropriate material selection for various segments of the tube, such as the end and middle segments, allow for custom tubes with properties that cannot be achieved with tubes formed from a single material or even laminated materials. The alternating extrusion technology (AET) described herein allows for custom designs such as those shown in Figures 1-3.

[0026] Continuous tubing with alternating compositions along its length can also be used in pump infusion sets. Pump infusion sets typically include tubing attached to a pump to regulate fluid flow. In some applications, the tubing includes upper and lower fittings attached to both ends of the tubing. The tubing is typically made of a soft polymer (e.g., silicone) that can be compressed with relatively little force and fully recovers when the force is removed. However, silicone tubing is difficult to bond to other materials (e.g., polycarbonate (PC), acrylonitrile-butadiene-styrene (ABS), acrylic, and other plastics). Because bonding silicone to other plastics is difficult, mechanical / frictional devices are typically used to bond silicone to other plastics, such as fittings used with pumps. However, these bonding devices typically require a low pull force (approximately 3 lbf), i.e., the force required to cut silicone tubing bonded to another plastic. This is due, first, to the lack of intermolecular welding, and second, to the fact that silicone is a softer material and therefore more easily deformed.

[0027] However, a continuous tube having alternating compositions along its length according to the present disclosure can replace conventional silicone tubing that is bonded to other plastics via mechanical / frictional devices, and thus, a continuous tube having alternating compositions along its length according to the present disclosure can advantageously minimize the components required to bond the tube to other devices.

[0028] An example of a continuous tube having alternating hard-soft-hard segments is shown in FIG. 4. As shown, tube 400 has first and third segments (410, 430) at opposite ends of the tube and a middle segment (420). In this example, the end segments (410 and 430) comprise a composition that results in a hard segment, e.g., having a Shore A hardness of at least about 70 A (e.g., 70 A to about 85 A), while the middle segment (420) is comprised of a composition that forms a soft segment, e.g., having a Shore A hardness of about 60 A or less (e.g., between about 55 A and 50 A). Such a continuous tube can be formed by alternately extruding first and second compositions and cutting the thus-formed tube within the first segment formed from the first composition. Additionally, tubing having hard-flexible-hard segments can be formed from a first composition comprising a rigid PVC polymer composition integrally bonded by sequential extrusion to an intermediate segment formed from a softer PVC composition having a hardness of about 50A to about 55A. The rigid PVC polymer composition used in the first segment can contain a lower amount of plasticizer than the soft PVC polymer composition used in the second segment. The intermediate segment of the hard-flexible-hard segmented tubing can be made to have flexibility comparable to that of silicone while still having rigid end segments that can be used for attachment to fittings.

[0029] Additionally, the transitions between segments are seamless, allowing the joining hard-soft-hard segments to be integral with one another and approximately as strong as the material composition of the segments themselves. Such integrally formed hard-soft-hard tubing end segments can be joined to the upper and lower fitting components (422, 432, respectively) by solvent bonding rather than mechanically joining the fittings. As a result, pull-out forces are expected to be much higher (approximately 15 lbf or greater) than silicone mechanical joints.

[0030] Additionally, continuous tubing with alternating compositions along its length can be used as a medical device, such as a catheter tubing. Certain conventional catheter tubing utilizes silicone with a lubricious coating on its end, prepared by a secondary process after the silicone tubing is formed. A lubricious coating is desirable because it allows silicone catheters to be more easily inserted into delicate mucosal tissue. However, problems can arise with controlling the amount of lubricant or coating, achieving uniform coverage throughout the tubing, and reduced effectiveness due to shear during insertion, as well as cost and complexity from secondary processes for applying the lubricious coating to the catheter. Advantageously, the process described herein can produce catheter tubing with a first segment that is a lubricious material formed from a composition of one or more polymers and lubricious additives, including, for example, thermoplastic urethane, PVC, polyether block amide. Such polymers can be formulated with lubricious additives, such as EveGlide, Mobilize, PEBASlide, and ProPellS, among others. The second segment can be made from a second composition material typical of catheters, such as thermoplastic polyurethane (TPU), PVC, polyether block amide, or a combination thereof.

[0031] It is understood that any specific 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 specific order or hierarchy of blocks in the processes can be rearranged, or all of the blocks shown can be performed. In some implementations, any of the blocks can be performed simultaneously.

[0032] This disclosure is provided to enable those 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.

[0033] Reference to a singular element is intended to mean "one or more" and not "one and only one" unless otherwise specified. The term "some" refers to one or more unless otherwise noted. Masculine pronouns (e.g., his) include feminine and neuter forms (e.g., her and its), and vice versa. Headings and subheadings, if any, are used for convenience only and are not intended to limit the invention.

[0034] 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.

[0035] As used herein, the phrase "at least one" preceding a list of items, with the term "or" separating any of the items, modifies the entire list rather than each item in the list. The phrase "at least one" 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. By way of example, 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.

[0036] 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 regarding an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as an 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 regarding an embodiment may apply to all embodiments, or to one or more embodiments. An embodiment may provide one or more examples. A phrase such as embodiment may refer to one or more embodiments, 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 regarding a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as configuration may refer to one or more configurations, and vice versa.

[0037] In one aspect, unless otherwise stated, all measurements, values, ratings, locations, dimensions, sizes, and other specifications set forth herein, including the following claims, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and that which is customary in the art to which they pertain.

[0038] It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is a description of example approaches. It is understood that the specific order or hierarchy of steps, operations, or processes can be rearranged based on design preferences. Some steps, operations, or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically without user intervention. The accompanying methods claim to present elements of the various steps, operations, or processes, if any, in a sample order, and are not intended to be limited to the specific order or hierarchy presented.

[0039] 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. Claim elements are not 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, the element is recited using the phrase "step for." Furthermore, to the extent terms such as "include" or "have" are used, such terms are intended to be inclusive in the same manner as the term "comprise" is interpreted when used as a transitional term in a claim.

[0040] The title, background, summary, brief description of the drawings, and abstract of this disclosure are incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. They are submitted with the understanding that they will not be used to limit the scope or meaning of the claims. It will also be appreciated that the detailed description provides illustrative examples and that various configurations are 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 configurations than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all configurations of a single disclosed configuration or operation. The following claims are incorporated into the detailed description, with each claim standing on its own as separately claimed subject matter.

[0041] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the claims as written, including all legal equivalents. Nevertheless, no claim is intended to, and should not be construed to, cover subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. A continuous tube having alternating compositions along the length of the tube, the continuous tube comprising: at least a first segment along the length of said continuous tube having a first polymer composition; at least a second segment along the length of the continuous tube having a second polymer composition; at least a third segment along the length of the continuous tube having a third polymer composition; Including, the at least first segment is integrally joined along the length of the continuous tube by the second segment and a transition segment between the first segment and the second segment, the transition segment comprising a mixture of the first polymer composition and the second polymer composition; the at least third segment is integrally joined to the second segment by a transition segment between the second segment and the third segment, the transition segment comprising a blend of the second polymer composition and the third polymer composition; the first segment and the third segment are joined to the second segment at opposite ends of the second segment; the first polymer composition comprises a first polymer and the second polymer composition comprises a second polymer different from the first polymer; The continuous tube, wherein the Shore A hardness of the first segment and the third segment is greater than the Shore A hardness of the second segment.

2. 10. The continuous tubing of claim 1, wherein the first and second segments have Shore A hardnesses that differ by at least 10%.

3. 10. The continuous tubing of claim 1, wherein the continuous tubing is a medical tubing for administering medical fluids by infusion.

4. 10. The continuous tube of claim 1, wherein the first segment comprises a polyvinyl chloride composition.

5. 10. The continuous tube of claim 1, wherein the first segment and the second segment Shore A hardness differ by at least 5%.

6. 10. The continuous tube of claim 1, wherein the first segment and the third segment have essentially the same polymer composition.

7. 7. The continuous tube of claim 6, wherein the polymer composition of the first and third segments comprises a non-hydrogenated styrenic TPE and the polymer composition of the second segment comprises a hydrogenated styrenic TPE.

8. 7. The continuous tube of claim 6, wherein the first and third segments have a Shore A hardness of at least about 70 and the second segment has a Shore A hardness of about 60 or less.

9. 10. The continuous tubing of claim 1, wherein the first polymer composition comprises a lubricious polymer and the second polymer composition comprises a thermoplastic polyurethane (TPU), polyvinyl chloride, polyether block amide, or a combination thereof.

10. 10. The continuous tubing of claim 1, wherein the first polymer composition comprises a styrenic thermoplastic elastomer (TPE), a non-hydrogenated styrenic TPE, an ester-based polyurethane, an ether-based polyurethane, a carbonate-based polyurethane thermoplastic, a thermoplastic olefin (TPO), or a combination thereof.

11. 10. The continuous tube of claim 1, wherein the second polymer composition comprises styrenic TPEs, non-hydrogenated and hydrogenated styrenic TPEs and blends thereof, ester-based polyurethanes, ether-based polyurethanes, carbonate-based polyurethane thermoplastics, EVA, EVA blends with thermoplastic polyurethanes (TPU), polyethylene vinyl acetate (EVA) blends with LDPE, TPO, PVC, etc., and combinations thereof.

12. 10. The continuous tube of claim 1, wherein the first and second polymer compositions contain different types or amounts of additives.

13. 1. A method for forming a continuous tube having alternating compositions along the length of the tube, the method comprising: extruding a first segment of tubing from a first polymer composition along the length of the continuous tube with a first pump on an extrusion line, followed by extruding a second segment of tubing from a second polymer composition along the length of the continuous tube with a second pump on the extrusion line; and extruding a third segment of said tubing from a third polymer composition along the length of said continuous tubing with a third pump on said extrusion line. Including, the first and second segments are integrally joined along the length of the continuous tube by a transition segment between the first and second segments; formed by sequential extrusion of the first and second segments, the transition segment comprising a mixture of the first polymer composition and the second polymer composition; the second segment and the third segment are integrally joined by a transition segment between the second segment and the third segment, the transition segment comprising a mixture of the second polymer composition and the third polymer composition; the first segment and the third segment are joined to the second segment at opposite ends of the second segment; the first polymer composition comprises a first polymer and the second polymer composition comprises a second polymer different from the first polymer; The method, wherein the Shore A hardness of the first segment and the third segment is greater than the Shore A hardness of the second segment.

14. 14. The method of claim 13, wherein the first segment has a Shore A hardness that differs from the second segment by at least 5%.

15. 14. The method of claim 13, wherein the first polymer composition comprises a lubricious polymer and the second polymer composition comprises a thermoplastic polyurethane, polyvinyl chloride, polyether block amide, or a combination thereof.

16. 15. The method of claim 14, wherein the polymer composition of the first and third segments comprises a non-hydrogenated styrenic TPE and the polymer composition of the second segment comprises a hydrogenated styrenic TPE.

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