Gamma stability enhancing pump pipe

Abstract

A composite tube is disclosed having at least one porous polyethylene layer that absorbs at least one elastomer to form a composite layer having an elastic modulus of less than 40 MPa and a main melting peak temperature of less than 135 DEG C. The at least one elastomer is a thickness that absorbs at least partially through the porous polyethylene layer. The porous polyethylene layer may include expanded polyethylene (ePe) or ultra high molecular weight expanded polyethylene (eUHMWPE). In some embodiments, the at least one elastomer forms a coating on the polyethylene layer. The composite tube may have a volume fraction of about 1% to about 20% and an elastic modulus of about 1 MPa to about 40 MPa. The gamma sterilized polymer composite tube may have an average pump life of from about 80 hours to about 5000 hours. In some embodiments, the composite tube may include a reinforcing membrane.

Description

Technical Field

[0001] The present disclosure relates generally to pump tubing and, more particularly, to sterilizable composite pump tubing comprising an elastomer reinforced with polyethylene. Background Art

[0002] Silicone elastomers can be made into a variety of forms, for example, for use in the medical, electrical, and chemical industries. Products such as peristaltic pump tubing, pump diaphragms, bellows, baby bottle nipples, wire and cable jackets, gaskets, and O-rings are often made from silicone elastomers. In addition, many of these products are used in applications that require repeated bending. For example, peristaltic pumps are used to transfer liquids and pastes through an elastic tube, where the tube is squeezed between a set of rotating rollers and a fixed pump housing. Silicone elastomers are commonly used in peristaltic pump tubing. However, after repeated bending, the sidewalls of silicone rubber tubing can crack, severely break, or lose their resilience, resulting in flow attenuation. This problem is even more serious when pumping fluids under high pressure and high temperature, resulting in a shorter pump tubing life.

[0003] Silicone is a class of inherently flexible polymers with a silanol oxygen repeating unit, and its bond rotation resistance is very small. Therefore, silicone has excellent low-temperature performance; however, its intermolecular and intramolecular polymer interactions are weak, resulting in poor tear strength and toughness. Therefore, particulate inorganic fillers or soluble silicone resin fillers are generally used to reinforce silicone elastomers. It is known that inorganic fillers (such as fumed silica) increase the tensile strength of dimethyl silicone oil tenfold. Some silicone elastomers are limited to a tensile strength of about 1,300 psi (ASTM D-412) and a tear strength of 250 ppi (ASTM D-624 die B). On the other hand, the tensile properties and tear properties of natural rubber are significantly higher; however, it lacks many useful properties of silicone elastomers, such as low-temperature flexibility, low dielectric loss, ozone resistance, low extractability, and radiation resistance.

[0004] Previously, silicones have been reinforced with polymers such as polytetrafluoroethylene (PTFE) or expanded PTFE (ePTFE) to improve durability (see Zumbrum et al., U.S. Pat. No. 6,451,396). However, when gamma irradiation is used as a sterilization technique, such as for sterilizing the tubing of disposable pump systems, the polymer degrades upon exposure to gamma radiation, resulting in a short pump life. Therefore, there is a continuing need for more durable pump tubing, particularly when the tubing is sterilized using gamma radiation (i.e., γ-sterilization). Summary of the Invention

[0005] The present disclosure generally relates to composite pump tubing having an elastomer reinforced with porous polyethylene.

[0006] According to a first embodiment ("embodiment 1"), the composite pipe comprises a pipe wall comprising at least one porous polyethylene layer, each of said porous polyethylene layers imbibing at least one elastomer, thereby forming a composite layer having an elastic modulus of less than 40 MPa and a main melting peak temperature of less than 135°C.

[0007] Embodiment 2 is the composite tube of embodiment 1, wherein the composite tube has an average pump life of greater than 80 hours.

[0008] Embodiment 3 is the composite tube according to embodiment 1 or 2, wherein the volume fraction of the tube wall is 1% to 20%.

[0009] Embodiment 4 is the composite tube of embodiment 3, wherein the elastic modulus of the composite layer is from about 1 MPa to about 40 MPa.

[0010] Embodiment 5 is the composite tube of embodiment 4, wherein the composite layer has an elastic modulus of about 1 MPa to about 24 MPa.

[0011] Embodiment 6 is the composite tube of embodiment 5, wherein the elastic modulus of the composite layer is from about 1 MPa to about 13 MPa.

[0012] Embodiment 7 is the composite tube of embodiment 6, wherein the elastic modulus of the composite layer is from about 1 MPa to about 7 MPa.

[0013] Embodiment 8 is the composite tube of any one of embodiments 1-7, wherein the porous polyethylene is expanded polyethylene (ePe).

[0014] Embodiment 9 is the composite tube of any one of embodiments 1-8, wherein the porous polyethylene is expanded ultra-high molecular weight polyethylene.

[0015] Embodiment 10 is a composite tube as described in any of embodiments 1-9, wherein the elastomer is selected from: silicone, diene-based rubber, butyl rubber, fluoroelastomer, perfluoroelastomer, perfluoropolyether elastomer, or thermoplastic elastomer including styrene, polyether, polyester, polyurethane block copolymers, or combinations thereof.

[0016] Embodiment 11 is the composite tube of any of embodiments 1-10, wherein the at least one elastomer is at least partially absorbed through the thickness of the porous polyethylene layer.

[0017] Embodiment 12 is a composite tube as described in any of embodiments 1-11, wherein the composite tube is gamma-sterilized, steam sterilized, autoclaved, EtO sterilized, X-ray sterilized, e-beam sterilized, dry heat sterilized, or cleaned in place (CIP).

[0018] Embodiment 13 is the composite tube of any one of embodiments 1-12, wherein the tube is a peristaltic pump tube.

[0019] According to another embodiment ("Embodiment 14"), the peristaltic pump tube comprises a tube wall having at least one porous polyethylene layer, each of the porous polyethylene layers being imbibed with at least one elastomer to form a composite layer having an elastic modulus of less than 40 MPa; wherein the peristaltic pump tube has an average pump life of 300 to 5,000 hours.

[0020] Embodiment 15 is the pump tube of embodiment 14, wherein the main melting peak temperature of the composite layer is less than 135°C.

[0021] Embodiment 16 is the pump tube of embodiment 14 or 15, wherein the volume fraction of the tube wall is 1% to 13%.

[0022] Embodiment 17 is the pump tube of embodiment 16, wherein the elastic modulus of the composite layer is from about 1 MPa to about 40 MPa.

[0023] Embodiment 18 is the pump tube of embodiment 17, wherein the elastic modulus of the composite layer is from about 1 MPa to about 24 MPa.

[0024] Embodiment 19 is the pump tube of embodiment 18, wherein the elastic modulus of the composite layer is from about 1 MPa to about 13 MPa.

[0025] Embodiment 20 is the pump tube of embodiment 19, wherein the elastic modulus of the composite layer is from about 1 MPa to about 7 MPa.

[0026] Embodiment 21 is the pump tubing of any one of embodiments 14-20, wherein the peristaltic pump tubing is gamma-sterilized, steam sterilized, autoclaved, EtO sterilized, X-ray sterilized, e-beam sterilized, dry heat sterilized, or cleaned in place (CIP).

[0027] Embodiment 22 is the pump tubing of any one of embodiments 14-21, wherein the at least one elastomer is at least partially absorbed through the thickness of the porous polyethylene layer.

[0028] Embodiment 23 is a composite tube as described in any of embodiments 14-22, wherein the elastomer is selected from: silicone, diene-based rubber, butyl rubber, fluoroelastomer, perfluoroelastomer, perfluoropolyether elastomer, or thermoplastic elastomer including styrene, polyether, polyester, polyurethane block copolymers, or combinations thereof.

[0029] Embodiment 24 is the pump tubing of embodiment 14, wherein the at least one porous polymer layer is selected from the group consisting of porous polyethylene, polypropylene, poly(etherketone) (PEEK), and copolymers of ethylene and at least one comonomer.

[0030] Embodiment 25 is the pump tubing of any one of embodiments 14-24, wherein the at least one porous polymer layer comprises at least one of expanded polyethylene and ultra-high molecular weight polyethylene.

[0031] In yet another embodiment (embodiment "26"), the composite pipe comprises a pipe wall comprising at least one polyethylene layer, each of said polyethylene layers being coated with at least one elastomer, thereby forming a composite layer having an elastic modulus of less than 40 MPa and a main melting peak temperature of less than 135°C.

[0032] Embodiment 27 is the composite tube of embodiment 26, wherein the composite tube has an average pump life of greater than about 80 hours.

[0033] Embodiment 28 is the composite tube of embodiment 26 or 27, wherein the volume fraction of the tube wall is 1% to 20%.

[0034] Embodiment 29 is the composite tube of embodiment 28, wherein the composite layer has an elastic modulus of about 1 MPa to about 40 MPa.

[0035] Embodiment 30 is the composite tube of embodiment 29, wherein the composite layer has an elastic modulus of about 1 MPa to about 24 MPa.

[0036] Embodiment 31 is the composite tube of embodiment 30, wherein the composite layer has an elastic modulus of about 1 MPa to about 13 MPa.

[0037] Embodiment 32 is the composite tube of embodiment 31, wherein the composite layer has an elastic modulus of about 1 MPa to about 7 MPa.

[0038] Embodiment 33 is a composite tube as described in any of embodiments 26-32, wherein the elastomer is selected from: silicone, diene-based rubber, butyl rubber, fluoroelastomer, perfluoroelastomer, perfluoropolyether elastomer, or thermoplastic elastomer including styrene, polyether, polyester, polyurethane block copolymers, or combinations thereof.

[0039] Embodiment 34 is a composite tube as described in any one of embodiments 26-33, wherein the polyethylene layer comprises expanded polyethylene.

[0040] Embodiment 35 is a composite tube as described in any one of embodiments 26-34, wherein the polyethylene layer comprises expanded ultra-high molecular weight polyethylene.

[0041] Embodiment 36 is the composite pipe of any one of embodiments 26-35, wherein the at least one elastomer forms a coating on at least one polyethylene layer.

[0042] Embodiment 37 is a composite tube as described in any of embodiments 26-36, wherein the composite tube is gamma-sterilized, steam sterilized, autoclaved, EtO sterilized, X-ray sterilized, e-beam sterilized, dry heat sterilized, or cleaned in place (CIP).

[0043] Embodiment 38 is the composite tube of any one of embodiments 26-37, wherein the tube is a peristaltic pump tube.

[0044] In another example ("Embodiment 39"), the peristaltic pump tubing comprises gamma-sterilized polymer tubing having an average pump life of 300 to 5,000 hours.

[0045] In another example (embodiment "40"), the sterilized non-fluorinated polymer tubing has an average pump life of 300 to 5,000 hours.

[0046] The above embodiments are intended to be limiting and should not be construed as limiting or otherwise narrowing the scope of any inventive concepts otherwise provided herein. Although multiple embodiments are disclosed, other embodiments will be readily apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] The accompanying drawings are included to provide a further understanding of the disclosure, and are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description serve to explain the concept of the disclosure.

[0048] Figure 1 A peristaltic pump having a pump tube according to one embodiment;

[0049] Figure 2 is a cross-sectional view of a pump tube according to one embodiment; and

[0050] Figure 3 3 is a differential scanning calorimetry (DSC) curve of a composite tube having a silicone elastomer reinforced with UHMWPE according to one embodiment. DETAILED DESCRIPTION

[0051] Definitions and Terminology

[0052] This disclosure is not intended to be interpreted in a limiting sense. For example, the terms used in this application should be interpreted broadly in the context of the meanings given to such terms in the art.

[0053] As used herein, the term "membrane" refers to a polymer in the form of a substantially two-dimensional sheet, wherein both the length and width are much greater than the thickness, for example, both the length and width are at least 100 times greater than the thickness. In some embodiments, the membrane is a microporous membrane having a structure that allows, for example, water vapor to pass through the thickness of the membrane while preventing liquid water from permeating from one side of the membrane to the other.

[0054] The term "film" refers to a membrane in which the pores are at least partially filled with a polymer so that gas or liquid does not flow through the open pore channels in the membrane.

[0055] As used herein, the term "porous" refers to a membrane or layer having a porosity sufficient to allow penetration by an elastomer.

[0056] As used herein, the term “on” is intended to describe that one element is directly on another element or is indirectly on the other element with intervening elements present.

[0057] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0058] As used herein, the term "pump life" is intended to describe the amount of time the tubing in a peristaltic pump can withstand use before failing.

[0059] As used herein, the term "winding number" is intended to describe the number of polymer (eg, expanded polyethylene) layers within the pipe wall.

[0060] As used herein, the term "volume fraction" is intended to describe the proportion of polymer (eg, expanded polyethylene) relative to elastomer (eg, silicone) in a given tubing configuration, expressed as a percentage (%) of the total volume.

[0061] As used herein, the term "gamma irradiation" is intended to describe a sterilization technique in which tubing is subjected to gamma radiation. Gamma radiation can be measured in kilograys (kGy).

[0062] The terms "ultra-high molecular weight polyethylene" and "(UHMWPE)" are used interchangeably and, as used herein, are intended to describe homopolymers of ethylene or copolymers of ethylene and at least one comonomer, such as an alpha olefin or a cyclic olefin having 3 to 20 carbon atoms. The comonomer in the UHMWPE copolymer may be present in an amount of about 0.001 mol% to about 10 mol%. The weight average molecular weight (Mw) of the UHMWPE polymer is between about 500,000 g / mol and about 10,000,000 g / mol.

[0063] As used herein, the term "differential scanning calorimetry (DSC) curve" is intended to describe a schematic curve that shows the amount of energy (y) required to maintain each temperature (x) while scanning a range of temperatures.

[0064] As used herein, the term "main melting peak temperature" is intended to describe the peak temperature in the maximum melting endothermic peak defined by the endothermic peak area of ​​the DSC curve.

[0065] The terms "about" and "approximately" are to be understood as plus or minus 10% of the stated value.

[0066] Description of each embodiment

[0067] Those skilled in the art will readily appreciate that various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the drawings referenced herein are not necessarily drawn to scale, but may be exaggerated in order to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be considered limiting.

[0068] The present disclosure generally relates to composite pump tubing having an elastomer reinforced with porous polyethylene. Figure 1 Detailed description of the embodiment of a peristaltic pump 100 with a pump tube 102 .

[0069] Figure 2 FIG is a cross-sectional view of a composite tube 200 according to one embodiment. The composite tube 200 may be a peristaltic pump (e.g., Figure 1 In some cases, the composite tube 200 can be used for a pinch valve. In some cases, for example, Figure 2 As shown, composite tube 200 can have a concentric circular cross-sectional shape. In some cases, composite tube 200 can have a spiral cross-section.

[0070] In one embodiment, if Figure 2 As shown, the composite pipe 200 includes a pipe wall (w) having at least one porous polyethylene layer 204. Each porous polyethylene layer 204 can be imbibed with at least one elastomer 206 to form a composite layer 208 having an elastic modulus of less than about 40 MPa and a main melting peak temperature of less than about 135°C. For example, Figure 2 Composite tube 200 is shown having a tube wall (w) comprising five composite layers 208. In some cases, the primary melting peak temperature of composite layer 208 can be greater than about 127°C and less than about 145°C. In oriented films (e.g., films stretched or oriented in one direction), a secondary melting temperature higher than the primary melting peak temperature can be observed. This secondary melting temperature (e.g., associated with a second endotherm) can be from about 145°C to about 155°C.

[0071] The composite layer 208 can be produced by any of a variety of methods, including gravure coating to impregnate a porous polyethylene layer with an elastomer, for example, as discussed and illustrated in (U.S. Patent No. 6,451,396 to Zumbrum et al.). Optionally, the impregnated polyethylene layer (i.e., composite layer 208) can be transferred to another roller to apply a top coat of liquid elastomer. The amount of liquid elastomer impregnated into the polyethylene layer can be varied to produce a composite material having a desired elastomer content. The coated structure is then rolled up around a cylindrical mandrel in an uncured state and wound to the desired wall thickness, or passed through a convection oven to cure the liquid elastomer to form a polyethylene reinforced elastomeric film. In the uncured state, the elastomer-impregnated polyethylene can be heated on the mandrel to form a tubular article, such as a pump tube (e.g., as Figure 1 In some cases, the coated film can be wound onto a mandrel and cut into strips of the desired width. This strip can then be wound onto a mandrel using filament winding techniques to create three-dimensional objects of irregular shapes and unlimited length.

[0072] In some embodiments, the volume fraction of the composite tube 200 may be from about 1% to about 20% of the ratio of polymer to elastomer in a given tube configuration, expressed as a percentage (%) of the total volume. In some cases, the volume fraction of the composite tube 200 may be from about 2% to about 18%, or from about 3% to about 15%, or from about 4% to about 14%, or from about 4% to about 13%. In one embodiment, the volume fraction of the composite tube 200 may be from about 7% to about 13%. In another embodiment, the volume fraction of the composite tube 200 may be from about 4% to about 7%.

[0073] In some examples, the elastic modulus value of composite layer 208 is related to the volume fraction of the UHMWPE-based reinforcement film. In some embodiments, the elastic modulus of composite layer 208 may range from about 1 MPa to about 40 MPa, about 1 MPa to about 35 MPa, about 1 MPa to about 30 MPa, about 1 MPa to about 25 MPa, about 1 MPa to about 20 MPa, about 1 MPa to about 15 MPa, about 1 MPa to about 10 MPa, or about 1 MPa to about 5 MPa. In some embodiments, the elastic modulus of composite layer 208 may range from about 1 MPa to about 7 MPa, about 1 MPa to about 13 MPa, or about 1 MPa to about 24 MPa. The Voight two-phase composite model can be used to estimate how the elastic modulus of composite layer 208 varies with the volume fraction of the reinforcement film. Table 1 contains the upper and lower limits of the elastic modulus range of different volume fractions of pipes estimated using the Voight composite model. The inner diameter of the pipe is about 6.4 mm and the wall thickness is 2.4 mm. The Voight two-phase composite model calculates the elastic modulus of the composite layer (E c) and the volume fraction of the elastomer (V e ), volume fraction of reinforcement layer (V f ), elastic modulus of elastomer (E e ) and the elastic modulus of the reinforcement layer (E f ) are related as follows: E c =E f V f +E e V e Table 1

[0074]

[0075]

[0076] In some examples, the porous polyethylene of layer 204 may be expanded polyethylene (ePe). In some embodiments, the porous polyethylene may be expanded ultra-high molecular weight polyethylene (eUHMWPE). The primary melting peak temperature of the eUHMWPE polymer may be greater than about 127°C and less than about 145°C. A secondary melting temperature, higher than the primary melting peak temperature, may be observed in the oriented film. For eUHMWPE, this secondary melting temperature (e.g., associated with the second endotherm) is about 145°C to about 155°C.

[0077] In some cases, the polyethylene forming polyethylene layer 204 (hereinafter referred to as "polyethylene") may include a filler, such as fumed silica, colloidal silica, carbon black, or a combination thereof. In some cases, the polyethylene may include a plasma treatment. In some cases, the polyethylene may optionally include a silane coupling agent. The density of polyethylene layer 204 may be from about 0.05 g / cc to about 0.8 g / cc. In some embodiments, the density of layer 204 may be from about 0.1 g / cc to about 0.7 g / cc, from about 0.2 to about 0.6 g / cc, from about 0.3 to about 0.5 g / cc, or from about 0.3 to about 0.4 g / cc.

[0078] In some embodiments, the wall thickness of the composite tube 200 [i.e., the thickness of the tube wall (w)] may be from about 0.5 to about 10 mm. In some embodiments, the wall thickness of the composite tube 200 may be from about 0.9 to about 9.2 mm, from about 1 to about 8 mm, from about 1.1 to about 7 mm, from about 1.2 to about 6 mm, from about 1.3 to about 5.5 mm, or from about 1.4 to about 5 mm. In one embodiment, the wall thickness of the composite tube 200 may be from about 1.5 to about 4.9 mm. Each composite layer may have a thickness from about 0.3 to about 10 mm. The ratio of the composite tube wall thickness to the inner diameter may be less than about 2 mm, less than about 1.9 mm, less than about 1.8 mm, less than about 1.7 mm, or less than about 1.6 mm. The wrap count of the layers 204 within the composite tube 200 may be from about 1 to about 200, or from about 1 to about 190, or from about 1 to about 185, or from about 1 to about 180, or from 1 to about 175. In some embodiments, the wrap count of the layers 204 within the composite tube 200 may be from about 1 to about 170.

[0079] The composite tube 200 may include a reinforcement film, including but not limited to nonwovens, extruded and cast films, expansion films, and phase inversion membranes. If the reinforcement film produced does not have a suitable porosity, a suitable porosity can be introduced by mechanical methods. Polymers suitable for use as reinforcement films include but are not limited to polyethylene, polypropylene, polyether ketone (PEEK), and copolymers of ethylene and at least one comonomer. Suitable comonomers that can be used include but are not limited to alpha olefins or cyclic olefins having 3 to 20 carbon atoms.

[0080] In some examples, the average pump life of the composite tube 200 is from about 80 hours to about 5,000 hours. In some examples, the average pump life of the composite tube 200 is from about 88 hours to about 5,000 hours. In some embodiments, the average pump life of the composite tube 200 is from about 200 hours to about 4,000 hours. In some embodiments, the average pump life of the composite tube 200 is from about 250 hours to about 3,000 hours. In some embodiments, the average pump life of the composite tube 200 is from about 300 hours to about 3,000 hours. In some embodiments, when subjected to about 50 kGy of gamma radiation, the average pump life of the composite tube 200 is from about 100 hours to about 350 hours. In some embodiments, when subjected to about 50 kGy of gamma radiation, the average pump life of the composite tube 200 is from about 100 hours to about 320 hours. In some cases, the gamma radiation may be higher than 50 kGy. In some embodiments, the composite tube 200 may be subjected to gamma radiation at a dose of about 20 kGy to about 60 kGy, or about 20 kGy to about 50 kGy, or about 20 kGy to about 40 kGy. In some embodiments, the composite tube 200 may be subjected to gamma radiation at a dose of about 20 kGy to about 30 kGy. In some cases, the composite tube 200 may be subjected to multiple doses of gamma radiation.

[0081] In some examples, the at least one elastomer 206 can at least partially absorb through the thickness of the porous polyethylene layer 204, and the at least one elastomer 206 forms a coating on the at least one polyethylene layer 204. In some embodiments, for example, the at least one elastomer 206 can absorb from about 1% to about 100% through the polyethylene layer 204. In some embodiments, the at least one elastomer 206 can absorb from about 5% to less than or equal to 100%, from about 10% to less than or equal to 100%, from about 15% to less than or equal to 100%, or from about 20% to less than or equal to 100%.

[0082] Elastomer 206 may be selected from, but is not limited to, thermosetting elastomers and thermoplastic elastomers. Elastomer 206 may be solvated or directly processed into tubing. Thermosetting elastomers include diene-based rubbers, such as natural rubber, styrene-butadiene rubber (SBR), isoprene rubber (IR), butadiene rubber (BR), chloroprene rubber (CR), nitrile rubber (NBR), as well as butyl rubber (isobutylene / isoprene rubber (IIR)), ethylene / propylene rubber (EPM), ethylene / propylene / diene rubber (EPDM), polyurethane resin, silicone rubber, fluoroelastomer (FKM), perfluorinated fluoroelastomer (FFKM), fluorinated silicone rubber, and perfluoroether elastomer. Thermoplastic elastomers (TPE) may include styrene, polyether, polyester, and polyurethane block copolymers.

[0083] Elastomer 206 may include silicone (e.g., methyl silicone, phenyl silicone, fluorosilicone, etc.). In some cases, elastomer 206 may include silicone. In some cases, elastomer 206 may include methyl silicone, phenyl silicone, and fluorosilicone, or a combination thereof. In some cases, elastomer 206 may include a fluoroelastomer, a perfluoroelastomer, a perfluoropolyether elastomer, or a thermoplastic elastomer including styrene, polyether, polyester, or polyurethane block copolymers, or a combination thereof.

[0084] In some examples, the composite tube 200 can be sterilized. For example, the composite tube 200 can be sterilized by gamma (γ) radiation, steam, steam in place (SIP), clean in place (CIP), high pressure, electron beam, x-ray, dry heat, and ethylene oxide (EtO). In one embodiment, the composite tube 200 can be sterilized by gamma (γ) radiation.

[0085] In some embodiments, the peristaltic pump tubing comprises at least one porous polymer layer, each porous polyethylene layer being imbibed with at least one elastomer to form a composite layer having an elastic modulus of less than 40 MPa. In some instances, the average pump life of the gamma-sterilized polymer tubing is from about 24 hours to about 1950 hours, from about 25 hours to about 1900 hours, from about 26 hours to about 1850 hours, from about 27 hours to about 1830 hours, from about 28 hours to about 1810 hours, or from about 29 hours to about 1800 hours. In some instances, the average pump life of the gamma-sterilized polymer tubing is from about 30 hours to about 1780 hours.

[0086] In some embodiments, the composite pipe comprises a pipe wall comprising at least one polyethylene layer, each polyethylene layer being coated with at least one elastomer, thereby forming a composite layer having an elastic modulus of less than 11 MPa and a main melting peak temperature of less than 135°C. In some cases, the main melting peak temperature of the composite layer may be greater than about 127°C and less than about 145°C. A second high temperature endotherm may be observed in the oriented film. The second endotherm peak is between about 145°C and about 155°C. In some examples, the average pump life of the composite pipe is greater than about 190 hours. In some examples, the at least one elastomer forms a coating on at least one polyethylene layer.

[0087] In some embodiments, the peristaltic pump tubing comprises gamma-sterilized polymer tubing having an average pump life of about 80 hours to about 5000 hours, or about 83 hours to about 4500 hours, or about 85 hours to about 4000 hours, or about 88 hours to about 3500 hours. In some instances, the average pump life of the gamma-sterilized polymer tubing is about 90 hours to about 5000 hours, about 100 hours to about 4800 hours, about 110 hours to about 4600 hours, about 120 hours to about 4400 hours, about 130 hours to about 4200 hours, or about 140 hours to about 4100 hours. In some embodiments, the average pump life of the gamma-sterilized polymer tubing can be about 300 to about 3000 hours.

[0088] In some embodiments, the average pump life of the sterilized non-fluoropolymer tubing may be 80 to 5,000 hours, or about 83 hours to about 4,500 hours, or about 85 hours to about 4,000 hours, or about 88 hours to about 3,500 hours. In some embodiments, the average pump life of the sterilizable non-fluoropolymer tubing may be about 90 hours to about 5,000 hours, or about 100 hours to about 4,800 hours, or about 110 hours to about 4,600 hours, or about 120 hours to about 4,400 hours, or about 130 hours to about 4,200 hours, or about 140 hours to about 4,100 hours, or 150 hours to about 4,000 hours. In some embodiments, the average pump life of the sterilizable non-fluoropolymer tubing may be about 300 to about 3,000 hours.

[0089] Figure 3 FIG3 is a diagram of a differential scanning calorimetry (DSC) curve 300 of an ultra-high molecular weight polyethylene tube according to an embodiment. The main melting peak temperature (e.g., corresponding to the first endothermic peak) of the UHMWPE polymer is greater than about 127° C. and less than about 145° C. In some embodiments, for example, Figure 3 As shown in FIG, the primary melting peak temperature of the UHMWPE polymer may be located at the first peak 302 at 131° C. In some embodiments, the secondary melting temperature (e.g., corresponding to the second endothermic peak) may be as follows: Figure 3 As shown by the second peak 304, it is about 145°C to about 155°C.

[0090] Test Method

[0091] Pump life

[0092] The sample tubing was cut to lengths between 152 mm and 356 mm using a standard tubing cutter. The tubing was fitted with a single, high-polish quick-clamp sanitary fitting (the appropriate size depends on the requirements of the tubing to be tested), which was secured with a single shaft collar on one end of the tubing. The shaft collar was tightened with an Allen wrench until finger tight. The tubing was then placed in a pump driver (Masterflex model 07551-20) equipped with a pump head (Masterflex model 77200-52). The pump tubing was located in the center of the pump head. The end of the tubing was fitted with a quick clamp connection, and the shaft collar was positioned toward the flow outlet for setup. For counterclockwise rotation, the shaft collar was located on the right side of the pump head before the pump head was fully closed. For clockwise rotation, the shaft collar was placed on the left side of the pump head before the pump head was fully closed. The pump drive was then set to the following: Continuous Flow, 1700 RPM, Tubing Size ## (set the number to the appropriate size of tubing to be tested).

[0093] A fluid reservoir (Nalgene model 2015-2000) was filled with over 1800 mL of deionized water. The cap (Nalgene model 2135-5302) was replaced on the reservoir. Using a reducer barb mender / splicer, one tube from the reservoir cap was connected to the side of the sample tube that was not equipped with a quick-clamp connection.

[0094] The sample tube, equipped with a quick-clamp connection, was connected to the flow path using a quick-clamp tubing connector. The flow path consisted of the following components, listed in the order in which they were placed within the flow path: an outlet tube with a quick-clamp connector, a stainless steel check valve (McMaster-Carr Model 1874N13, commercially available from McMaster-Carr), a pressure sensor (GEMS SENSORS Model 2200BGG1002A3UA), a pressure regulator (Go regulator Model BP3-2A41I5I111), a flow meter (IFM efector Model SM600) fitted with an adapter (IFMefector Model E40200), and then connected back to the fluid reservoir using a speed reduction barb patch / adapter. The pressure sensor was used to measure the pressure within the device throughout the test and collected using WONDERWARE software (sampling rate: 1 measurement every 30 seconds). During the entire test, the flow rate in the device was measured using a flow meter and collected by the WONDERWARE software (sampling rate was 1 measurement every 30 seconds).Then the pump driver was turned on and the pressure in the system was set to 20 psi using the pressure knob.

[0095] There are two situations in which a sample is considered to have failed the test. The first is a tubing rupture where liquid water is visible flowing from the pump head. The second is a flow decay where the flow rate data is analyzed throughout the test. The flow rate data is analyzed by recording the sample's initial flow rate value 2 minutes after the pressure is set to the desired value within the system. This initial flow rate value is then compared to the average flow rate of the test conducted over the last 30 minutes (e.g., a time of 1 hour and 3 minutes would report an average flow rate value calculated by averaging all flow rate data collected between minutes 33 and 1 hour and 3 minutes). If this average flow rate value drops below 75% of the initial flow rate value, the sample is considered to have failed the test and the test is stopped. The cumulative time from the start of the test to the time of tubing rupture or the time when the flow decay is >25% is reported in hours.

[0096] Differential scanning calorimetry (DSC) and main melting peak temperature

[0097] Differential scanning calorimetry data were collected using a TA Instruments Q2000 DSC (159 Lukens Avenue, New Castle, DE 19720) using TZero aluminum pans and lids. Scans were run from 25°C to 200°C at a rate of 10°C / min. A plug was cut from the sidewall of the tubing using a 2 mm diameter biopsy punch. The plug was then cut into pucks approximately 1 mm thick by 2 mm thick. The main melting peak temperature was defined as the peak of the melting endotherm below 145°C.

[0098] elastic modulus

[0099] Composite layer (such as Figure 2 The elastic modulus of the composite layer (shown as 208) was determined by peeling the layer from the tubing. The composite layer was peeled from the tubing by inserting blunt tweezers between the composite layers and cutting along the long axis of the tubing to initiate peeling. A sufficient length was peeled to obtain approximately a single composite layer. Tensile specimens were cut from the peeled layers in the circumferential direction (peeling direction) using an ASTM D638 V-type dog bone die. The specimens were tested on a 100N load cell equipped with a flat-faced grip. Tensile behavior was measured on a Model 5564 (Illinois Tool Works Inc., Norwood, Massachusetts). The distance between the grips was 25.4 mm, the gauge length was 7.62 mm, and the test was conducted at a crosshead speed of 1.27 mm / s (16.6 % / s). The elastic modulus was calculated from the initial linear portion of the engineering stress (load / area) / engineering strain (length change / gauge length) curve. At least two samples were tested, and the reported elastic modulus is the average of the individual values.

[0100] Thickness measurement

[0101] The sample thickness of the peel layer was measured using a Mitutoyo absolute digital micrometer model ID-C112E (Mitutoyo Corporation, Aurora, IL) and a 6.35 mm diameter flat-tip probe. Three measurements were made, and the average thickness was reported.

[0102] Volume fraction

[0103] The volume fraction of silicone was calculated by dividing the thickness of the silicone topcoat (i.e., the silicone that does not enter the membrane pores but is located on top of the membrane) by the thickness of the impregnation layer (e.g., Figure 2The silicone content in the impregnated layer is calculated by adding the thickness of the silicone in the layer 208 shown in FIG, wherein the impregnated layer is an ePE material layer containing silicone filling its pores. The silicone content in the impregnated layer is calculated by dividing the ratio of the expanded polyethylene density to the polyethylene density by the total thickness of the composite material.

[0104] In some embodiments, the silicone topcoat thickness may be about 0.056 mm with a density ratio (0.16 g / cc / 0.94 g / cc) of 0.17, which results in a silicone content in the impregnated layer of 0.02 mm, which when divided by the total thickness of 0.08 mm, is 5.1 volume %.

[0105] Example

[0106] Example 1

[0107] Peristaltic pump tubing ("Sample I") was prepared by first obtaining a UHMWPE film of the same composition as defined in U.S. Patent No. 10,577,468 to Sbriglia (d = 6.4 mm and w = 2.4 mm). The UHMWPE film was passed between a gravure roll and a silicone rubber roll, followed by two chrome rolls with a gap of 3.5 mils and containing liquid silicone, as described by Zumbrum et al. in U.S. Patent No. 6,451,396. The UHMWPE film was coated at a speed of 2 feet per minute and wound onto a mandrel with an outer diameter of 6.4 mm (i.e., the inner diameter of the composite tube). The resulting composite tube had a wall thickness of 2.4 mm.

[0108] The uncured composite tubing was then placed in a press at 135°C and 20 tons of pressure for 12 minutes and removed from the mandrel. The tubing was post-baked at 110°C for 6 hours for final curing and removal of any volatiles. Additional processing was then performed in the form of a heat treatment, as described in U.S. Patent Publication No. 2021 / 0317276 to Bell et al. The tubing was subsequently gamma sterilized at a value of 29 to 34 kGY. The resulting volume fraction of the produced tubing was determined to be 6%.

[0109] The composite elastomer tube of Sample I was then tested according to the Pump Life Test Method described above. The composite elastomer tube of Sample I ruptured at approximately 1781 hours (n=2, maximum=1942 hours). The elastic modulus of Sample I was determined to be 9.8 MPa. The melting peak temperature of Sample I was determined to be 132.7°C. The data is listed in Table 2.

[0110] Example 2

[0111] Peristaltic pump tubing ("Sample II") was prepared by first obtaining a UHMWPE film of the same composition as defined in U.S. Patent No. 10,577,468 to Sbriglia (d = 6.4 mm and w = 2.4 mm). The UHMWPE film was passed between a gravure roller and a silicone rubber roller, followed by two chrome rollers with a gap of 3.5 mils and liquid silicone, as described by Zumbrum et al. in U.S. Patent No. 6,451,396. The UHMWPE film was coated at a speed of 2 feet per minute and wound onto a mandrel with an outer diameter of 6.4 mm (i.e., the inner diameter of the composite tube). A wall thickness of 2.4 mm was obtained.

[0112] The uncured composite was then placed in a press at 135°C and 20 tons of pressure for 12 minutes and removed from the mandrel. The tubing was baked at 110°C for 6 hours for final curing and removal of volatiles. The tubing was then gamma sterilized at a value of 29 to 34 kGY. The resulting volume fraction of the produced tubing was determined to be 6%.

[0113] The composite elastomer tube of Sample II was then tested according to the Pump Life Test Method described above. The composite elastomer tube of Sample II ruptured at approximately 24 hours (n=2, maximum=26 hours). The elastic modulus of Sample II was determined to be 22.5 MPa. The melting peak temperature of Sample II was determined to be 138° C. The data is listed in Table 2.

[0114] Example 3

[0115] First, an ePe film (3P07A film from WL Gore & Associates GmbH, Heerlen, The Netherlands) was obtained to prepare a peristaltic pump tubing ("Sample III") (d = 6.4 mm and w = 2.4 mm). The ePe film was 0.016 mm thick and 914 mm wide and was obtained as a continuous roll. The density of the ePe film was 0.16 g / cc. The ePe film was passed between a gravure roller and a silicone rubber roller, and then passed through two chrome rollers with a gap of 3.5 mils and containing liquid silicone, as described by Zumbrum et al. in U.S. Patent No. 6,451,396. The ePe film was coated at a speed of 1 foot / minute and was wound onto a mandrel with an outer diameter of 6.4 mm (i.e., the inner diameter of the composite tube). A wall thickness of 2.4 mm was obtained.

[0116] The uncured composite material on the mandrel was then placed in a press at 135°C and 20 tons of pressure for 12 minutes before being removed from the mandrel. The pump tubing was post-baked at 110°C for 6 hours for final curing and removal of all volatiles. Additional processing in the form of heat treatment was performed as described in U.S. Patent Publication No. 2021 / 0317276 to Bell et al. The pump tubing was then gamma sterilized at a value of 45 kGY to 51 kGY. The resulting volume fraction of the produced pump tubing was determined to be 4%.

[0117] The composite elastomer tube of Sample III was then tested according to the Pump Life Test Method described above. The composite elastomer tube of Sample III ruptured at approximately 1011 hours (n=2, maximum=1031 hours). The elastic modulus of Sample III was determined to be 2.9 MPa. The melting peak temperature of Sample III was determined to be 131.8°C. The data is listed in Table 2.

[0118] Example 4

[0119] First, an ePe film (3P07A film from WL Gore & Associates GmbH, Heerlen, The Netherlands) was obtained to prepare a peristaltic pump tube ("Sample IV") (d = 6.4 mm and w = 2.4 mm). The ePe film had a thickness of 0.016 mm and a width of 914 mm and was obtained as a continuous roll. The density of the ePe film was 0.16 g / cc. The ePe film was passed between a gravure roller and a silicone rubber roller, and then passed through two chrome rollers with a gap of 3.5 mils and containing liquid silicone, as described by Zumbrum et al. in U.S. Patent No. 6,451,396. The ePe film was coated at a speed of 1 foot / minute and wound onto a mandrel with an outer diameter of 6.4 mm (i.e., the inner diameter of the composite tube). A composite tube with a wall thickness of 2.4 mm was obtained.

[0120] The uncured composite was then placed in a press at 135°C and 20 tons of pressure for 12 minutes before being removed from the mandrel. The tubing was baked at 110°C for 6 hours for final curing and removal of any volatiles. The tubing was then gamma sterilized at a value of 45 to 51 kGY. The resulting volume fraction of the produced tubing was determined to be 4%.

[0121] The composite elastomer tube of Sample IV was then tested according to the pump life test method described above. The composite elastomer tube of Sample IV ruptured at approximately 32 hours (n=2, maximum=53 ​​hours). The elastic modulus of Sample IV was determined to be 7.8 MPa. The melting peak temperature of Sample IV was determined to be 140.9°C. The data is listed in Table 2.

[0122] Example 5

[0123] First, an ePe film (3P07A film from WL Gore & Associates GmbH, Heerlen, The Netherlands) was obtained to prepare a peristaltic pump tube ("Sample V") (d = 6.4 mm and w = 2.4 mm). The ePe film had a thickness of 0.016 mm and a width of 762 mm and was obtained as a continuous roll. The density of the ePe film was 0.16 g / cc. The ePe film was passed between a gravure roller and a silicone rubber roller, and then passed through two chrome rollers with a gap of 1 mil and containing liquid silicone, as described by Zumbrum et al. in U.S. Patent No. 6,451,396. The ePe film was coated at a speed of 3 feet per minute and wound onto a mandrel with an outer diameter of 6.4 mm (i.e., the inner diameter of the composite tube). A composite tube with a wall thickness of 2.4 mm was obtained.

[0124] The uncured composite was then placed in an oven at 135°C for 24 minutes before being removed from the mandrel. The tubing was baked at 110°C for 6 hours for final curing and removal of any volatiles. Additional processing in the form of heat treatment was performed, as described in U.S. Patent Publication No. 2021 / 0317276 to Bell et al. The tubing was subsequently gamma sterilized at a value of 45 kGY to 51 kGY. The resulting volume fraction of the produced tubing was determined to be 11%.

[0125] The composite elastomer tube of Sample V was then tested according to the pump life test method described above. The composite elastomer tube of Sample V ruptured at approximately 474 hours (n=2, maximum=936 hours). The elastic modulus of Sample V was measured to be 13.3 MPa. The melting peak temperature of Sample V was measured to be 133.2°C. The data is listed in Table 2.

[0126] Table 2

[0127]

[0128]

[0129] The invention of this application has been described above generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments described herein without departing from the spirit and scope of the invention. Therefore, the embodiments are intended to cover such modifications and variations of the invention as come within the scope of the appended claims and their equivalents.

Claims

1. A composite pipe comprising: A pipe wall having at least one porous polyethylene layer, each of said porous polyethylene layers imbibing at least one elastomer to form a composite layer having an elastic modulus of less than 40 MPa and a main melting peak temperature of less than 135°C.

2. The composite pipe of claim 1, wherein the composite pipe has an average pump life of greater than 80 hours.

3. The composite pipe according to claim 1 or claim 2, wherein the volume fraction of the pipe wall is 1% to 20%.

4. The composite pipe of claim 3, wherein the composite layer has an elastic modulus of about 1 MPa to about 40 MPa.

5. The composite pipe of claim 4, wherein the composite layer has an elastic modulus of about 1 MPa to about 24 MPa.

6. The composite pipe of claim 5, wherein the composite layer has an elastic modulus of about 1 MPa to about 13 MPa.

7. The composite pipe of claim 6, wherein the composite layer has an elastic modulus of about 1 MPa to about 7 MPa.

8. The composite pipe according to any one of claims 1 to 7, wherein the porous polyethylene is expanded polyethylene (ePe).

9. The composite pipe according to any one of claims 1 to 8, wherein the porous polyethylene is expanded ultra-high molecular weight polyethylene.

10. The composite tube of any one of claims 1 to 9, wherein the elastomer is selected from the group consisting of silicone, diene-based rubber, butyl rubber, fluoroelastomer, perfluoroelastomer, perfluoropolyether elastomer, or thermoplastic elastomer including styrene, polyether, polyester, polyurethane block copolymers, or combinations thereof.

11. The composite pipe of any one of claims 1 to 10, wherein the at least one elastomer is at least partially absorbed through the thickness of the porous polyethylene layer.

12. The composite tube of any one of claims 1-11, wherein the composite tube is gamma-sterilized, steam sterilized, autoclaved, EtO sterilized, X-ray sterilized, e-beam sterilized, dry heat sterilized, or cleaned in place (CIP).

13. The composite tube of any one of claims 1 to 12, wherein the tube is a peristaltic pump tube.

14. Peristaltic pump tubing, comprising: a tube wall having at least one porous polymer layer, each of said porous polymer layers imbibing at least one elastomer to form a composite layer having an elastic modulus of less than 40 MPa; The average lifespan of the peristaltic pump tube is 300 to 5,000 hours. The pump tube of claim 14 , wherein the main melting peak temperature of the composite layer is less than 135° C.

16. The pump tube according to claim 14 or claim 15, wherein the volume fraction of the tube wall is 1% to 13%. The pump tubing of claim 16 , wherein the composite layer has an elastic modulus of about 1 MPa to about 40 MPa. The pump tubing of claim 17 , wherein the composite layer has an elastic modulus of about 1 MPa to about 24 MPa. The pump tubing of claim 18 , wherein the composite layer has an elastic modulus of about 1 MPa to about 13 MPa.

20. The pump tubing of claim 19, wherein the composite layer has an elastic modulus of about 1 MPa to about 7 MPa.

21. The pump tubing of any one of claims 14-20, wherein the peristaltic pump tubing is gamma-sterilized, steam sterilized, autoclaved, EtO sterilized, X-ray sterilized, e-beam sterilized, dry heat sterilized, or cleaned in place (CIP).

22. The pump tubing of any one of claims 14-21, wherein the at least one elastomer is at least partially absorbed through the thickness of the porous polyethylene layer.

23. The pump tube of any one of claims 14-22, wherein the elastomer is selected from the group consisting of silicone, diene-based rubber, butyl rubber, fluoroelastomer, perfluoroelastomer, perfluoropolyether elastomer, or thermoplastic elastomer including styrene, polyether, polyester, polyurethane block copolymers, or combinations thereof.

24. The pump tubing of claim 14, wherein the at least one porous polymer layer is selected from the group consisting of porous polyethylene, polypropylene, poly(ether ketone), and copolymers of ethylene and at least one comonomer.

25. The pump tubing of any one of claims 14-24, wherein the at least one porous polymer layer comprises at least one of expanded polyethylene and ultra-high molecular weight polyethylene.

26. A composite pipe comprising: A pipe wall having at least one polyethylene layer, each of said polyethylene layers being coated with at least one elastomer to form a composite layer having an elastic modulus of less than 40 MPa and a main melting peak temperature of less than 135°C.

27. The composite tube of claim 26, wherein the composite tube has an average pump life of greater than about 80 hours.

28. A composite tube according to claim 26 or claim 27, wherein the volume fraction of the tube wall is from 1% to 20%.

29. The composite pipe of claim 28, wherein the composite layer has an elastic modulus of about 1 MPa to about 40 MPa.

30. The composite pipe of claim 29, wherein the composite layer has an elastic modulus of about 1 MPa to about 24 MPa.

31. The composite pipe of claim 30, wherein the composite layer has an elastic modulus of about 1 MPa to about 13 MPa.

32. The composite pipe of claim 31, wherein the composite layer has an elastic modulus of about 1 MPa to about 7 MPa.

33. The composite tube of any one of claims 26-32, wherein the elastomer is selected from the group consisting of silicone, diene-based rubber, butyl rubber, fluoroelastomer, perfluoroelastomer, perfluoropolyether elastomer, or thermoplastic elastomer including styrene, polyether, polyester, polyurethane block copolymers, or combinations thereof.

34. The composite pipe of any one of claims 26-33, wherein the polyethylene layer comprises expanded polyethylene.

35. The composite pipe of any one of claims 26-34, wherein the polyethylene layer comprises expanded ultra high molecular weight polyethylene.

36. The composite pipe of any one of claims 26-35, wherein the at least one elastomer forms a coating on at least one polyethylene layer.

37. The composite tube of any one of claims 26-36, wherein the composite tube is gamma-sterilized, steam sterilized, autoclaved, EtO sterilized, X-ray sterilized, e-beam sterilized, dry heat sterilized, or cleaned in place (CIP).

38. The composite tube of any one of claims 26-37, wherein the tube is a peristaltic pump tube.

39. Peristaltic pump tubing, comprising: Gamma-sterilized polymer tubing with an average pump life of 300 to 5,000 hours.

40. Peristaltic pump tubing, comprising: Sterilizable non-fluoropolymer tubing with an average pump life of 300 to 5,000 hours.

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