Peristaltic pump tube and method of fabrication

Abstract

The peristaltic pump tube (100) comprises a silicone composition comprising a base silicone material, an accelerator, a curing agent, and a catalyst, wherein the base silicone material comprises a blend of a first silicone elastomer and a second silicone elastomer, the first silicone elastomer having a different Shore A durometer than the second silicone elastomer, the peristaltic pump tube (100) is used with a peristaltic pump at a rotor speed exceeding 600 revolutions per minute, and the silicone composition advantageously increases the pump life of the peristaltic pump tube (100).

Description

[Technical Field]

[0001] This disclosure generally relates to peristaltic pump tubes and methods for forming peristaltic pump tubes. [Background technology]

[0002] Silicone materials are widely used in the medical, pharmaceutical, food, and biotechnology industries due to their desired properties. For example, silicone materials are typically non-toxic, flexible, thermally stable, have low chemical reactivity, and can be manufactured in a variety of sizes. However, challenges remain with currently available silicone products. When silicone products are used as peristaltic pump tubing, the tubing is compressed by rollers to move the liquid. Commercially available silicone tubing materials have not yet achieved long service times at high speeds when used in peristaltic pump applications.

[0003] The development of high-performance tubing that can achieve the desired service time at rotor speeds faster than 600 rpm would be advantageous. More specifically, improved silicone-based peristaltic pump tubing is desired. [Overview of the project]

[0004] In one embodiment, the peristaltic pump tube comprises a silicone composition including a base silicone material, an accelerator, a curing agent, and a catalyst, wherein the base silicone material comprises a blend of a first silicone elastomer and a second silicone elastomer, the first silicone elastomer having a different Shore A durometer than the second silicone elastomer, and the peristaltic pump tube is used with the peristaltic pump at a rotor speed exceeding 600 rotations per minute (rpm).

[0005] In one embodiment, a method for forming a peristaltic pump tube comprises mixing a silicone composition comprising a base silicone material, an accelerator, a curing agent, and a catalyst, wherein the base silicone material comprises a blend of a first silicone elastomer and a second silicone elastomer, the first silicone elastomer having a Shore A durometer different from that of the second silicone elastomer, and forming the composition into at least one layer, and the peristaltic pump tube is used with a peristaltic pump at a rotor speed exceeding 600 revolutions per minute (rpm).

[0006] The peristaltic pump tube comprises a silicone composition comprising a base silicone material, an accelerator, a curing agent, and a catalyst, wherein the base silicone material comprises a blend of a first silicone elastomer and a second silicone elastomer, the first silicone elastomer having a different Shore A durometer than the second silicone elastomer, and the peristaltic pump tube has the following characteristics: a) total fragmentation by particles of size >2 μm after 1000 vial fillings, with a particle count of less than 5 particles / mL, e.g., less than 4 particles / mL, e.g., less than 3 particles / mL, e.g., less than 2 particles / mL, when pumped in a peristaltic pump at 300 rpm using distilled water, with a particle count of 1000 μm 2 Less than / mL, for example, 800μm 2 Less than / mL, e.g., 600μm 2 Less than / mL, for example, 400μm 2 Less than / mL, for example, 200μm 2 Total crushing area less than / mL (μm 2 It has at least one of the following ( / mL): [Brief explanation of the drawing]

[0007] This disclosure can be better understood by referring to the accompanying drawings, and many of its features and advantages will be revealed to those skilled in the art. [Figure 1] Includes an illustrative diagram of a tube. [Figure 2] It includes a graphical display of the tube life of an exemplary peristaltic pump tube and a comparative peristaltic pump tube. [Figure 3] It includes a graphical display of the flow rate of an exemplary peristaltic pump tube. [Figure 4] It includes a graphical display of the compression fatigue of an exemplary peristaltic pump tube and a comparative peristaltic pump tube. [Figure 5A] It includes photographs of the fracture behavior of an exemplary peristaltic pump tube and a comparative peristaltic pump tube. [Figure 5B] It includes photographs of the fracture behavior of an exemplary peristaltic pump tube and a comparative peristaltic pump tube.

[0008] The use of the same reference numerals in different drawings indicates like or identical elements.

Best Mode for Carrying Out the Invention

[0009] The following description, in combination with the drawings, is provided to assist in understanding the teachings disclosed herein. The following discussion focuses on specific implementations and embodiments of the teachings. This focus is provided to help explain the teachings and should not be construed as a limitation on the scope or applicability of the teachings.

[0010] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having,” or any other variations thereof are open-ended terms and should be interpreted as “includes, but not limited to.” These terms encompass the more restrictive terms “essentially consist of” and “consist of.” In one embodiment, a method, article, or apparatus containing a list of features may include other features not expressly enumerated, or other features inherent to such method, article, or apparatus, but not necessarily limited to those features. Furthermore, unless otherwise stated, “or” refers to an inclusive “or” rather than an exclusive “or.” For example, condition A or B is satisfied by one of the following: A is true (or exists) and B is false (or does not exist), A is false (or does not exist) and B is true (or exists), and both A and B are true (or exist).

[0011] Furthermore, the use of "a" or "an" is used to describe elements and components described herein. This is done simply for convenience and to give a general sense of the scope of the invention. This specification should be read as one or at least one, and singular forms include plural forms, or vice versa, unless it is clear that otherwise. For example, if a single article is described herein, two or more articles may be used instead of a single article. Similarly, if two or more articles are described herein, a single article may be replaced by those two or more articles.

[0012] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art in which the present invention pertains. The materials, methods, and examples are illustrative and not intended to be limiting. Many details relating to specific materials and processing procedures, beyond what is described herein, are conventional and can be found in references and other sources within the technical fields of construction and the corresponding manufacturing fields. Unless otherwise specified, all measurements are taken at approximately 25°C (i.e., room temperature). For example, viscosity values ​​are taken at 25°C unless otherwise specified.

[0013] In certain embodiments, the peristaltic pump tube comprises a silicone composition. The silicone composition comprises a silicone substrate, an accelerator, a curing agent, and a catalyst. The silicone composition advantageously increases the pump life of the peristaltic pump tube, more specifically when used at speeds exceeding 600 rpm (revolutions per minute). In one embodiment, the peristaltic pump tube has advantageous fracturing.

[0014] In one embodiment, the silicone composition comprises a base silicone material. In a particular embodiment, the base silicone material comprises at least one silicone elastomer. In a more particular embodiment, the base silicone material comprises a first silicone elastomer and a second silicone elastomer, wherein the first silicone elastomer has a Shore A durometer different from that of the second silicone elastomer. For example, the first silicone elastomer has a Shore A durometer of 50 or less, e.g., 20-50, e.g., 30-50, or even 35-45. In one embodiment, the second silicone elastomer has a Shore A durometer of 50 or more, e.g., 50-80, e.g., 60-80, or even 65-75. It will be understood that the durometer may be within a range between any of the above minimum and maximum values.

[0015] At least one silicone elastomer may include, for example, a polyorganosiloxane. Any polyorganosiloxane is conceivable, including, for example, silicon hydride-containing polyalkylsiloxanes, vinyl-containing polyalkylsiloxanes, aryl-containing polyalkylsiloxanes, hydroxyl-containing polyalkylsiloxanes, halogen-containing polyalkylsiloxanes, or combinations thereof. In one embodiment, the polyorganosiloxane may include any alkyl group, for example, any C1-6 alkyl group, or combinations thereof. In one embodiment, the polyorganosiloxane may be formed from precursors such as dimethylsiloxane, diethylsiloxane, dipropylsiloxane, methylethylsiloxane, methylpropylsiloxane, or combinations thereof. In a particular embodiment, the polyorganosiloxane may be a polydialkylsiloxane, for example, polydimethylsiloxane (PDMS). In certain embodiments, the polyorganosiloxane is a silicon hydride-containing polyalkylsiloxane, for example, a silicon hydride-containing polydimethylsiloxane. In further embodiments, the polyorganosiloxane is a vinyl-containing polyalkylsiloxane, for example, a vinyl-containing polydimethylsiloxane. In yet another embodiment, the silicone elastomer is a combination of a silicon hydride-containing polyalkylsiloxane and a vinyl-containing polyalkylsiloxane, for example, a combination of a silicon hydride-containing polydimethylsiloxane and a vinyl-containing polydimethylsiloxane.

[0016] In one embodiment, the base silicone material has an aliphatic unsaturated (vinyl) content of at least 0.01% by weight and 5% by weight or less, based on the total weight % of the base silicone material, as measured by H-NMR. In one embodiment, the aliphatic unsaturated content of the base silicone material is at least 0.03% by weight, or at least 0.05% by weight, or at least 0.1% by weight, or at least 0.3% by weight, or at least 0.5% by weight, or at least 0.7% by weight, or at least 1% by weight, or at least 2% by weight, or 3% by weight or less, or 1% by weight or less, or 0.7% by weight or less, or 0.5% by weight or less, or 0.3% by weight or less, or 0.1% by weight or less, or 0.05% by weight or less, based on the total weight % of the base silicone material, as measured by H-NMR. In more specific embodiments, when at least two silicone elastomers are used, the first silicone elastomer has an aliphatic unsaturated content of at least 0.01% and 5% or less of the first silicone elastomer, for example, 0.01% to 1% by weight, or even about 0.05% to 0.5% by weight, as measured by H-NMR. In one embodiment, the aliphatic unsaturated content of the first silicone elastomer is at least 0.03% by weight, or at least 0.05% by weight, or at least 0.1% by weight, or at least 0.3% by weight, or at least 0.5% by weight, or at least 0.7% by weight, or at least 1% by weight, or at least 2% by weight, or 3% or less by weight, or 1% or less by weight, or 0.7% or less by weight, or 0.5% or less by weight, or 0.3% or less by weight, or 0.1% or less by weight, or 0.05% or less by weight, as measured by H-NMR. In more specific embodiments, the second silicone elastomer has an aliphatic unsaturated content of at least 0.01% and no more than 5%, for example, 0.05% to 2% by weight, or even about 0.05% to 1% by weight, as measured by H-NMR.In one embodiment, the aliphatic unsaturated content of the second silicone elastomer is at least 0.03% by weight, or at least 0.05% by weight, or at least 0.1% by weight, or at least 0.3% by weight, or at least 0.5% by weight, or at least 0.7% by weight, or at least 1% by weight, or at least 2% by weight, or 3% or less by weight, or 1% or less by weight, or 0.7% or less by weight, or 0.5% or less by weight, or 0.3% or less by weight, or 0.1% or less by weight, or 0.05% or less by weight, as measured by H-NMR. It will be understood that the ratio may be within the range between any of the above minimum and maximum values.

[0017] For example, the base silicone material and / or silicone elastomer may contain halide functional groups, phenyl functional groups, or a combination thereof. For instance, the base silicone material may include fluorosilicone or phenylsilicone. Alternatively, the base silicone material may be nonpolar and not contain halide functional groups such as chlorine and fluorine, nor phenyl functional groups.

[0018] In one embodiment, the base silicone material and / or silicone elastomer has the following properties: a) a number of 200,000 g / mol to 1,000,000 g / mol, as measured by gas permeation chromatography (GPC) in THF, for example, at least 200,000 g / mol, or at least 300,000 g / mol, or at least 400,000 g / mol, or at least 500,000 g / mol, or 1,000,000 g / mol or less, or 800,000 g / mol or less, or 600,000 g / mol or less, or 400,000 g / mol or less. Average molecular weight, b) As measured by gas permeation chromatography (GPC) in THF, 200,000 g / mol to 1,000,000 g / mol, for example, at least 200,000 g / mol, or at least 300,000 g / mol, or at least 400,000 g / mol, or at least 500,000 g / mol, or 1,000,000 g / mol or less, or 800,000 g / mol or less, or 600,000 g / mol or less, or 400,a) Weight-average molecular weight of 000 g / mol or less, c) Mooney viscosity of at least 15 and 60 (ML(1+4) at 100°C), e.g., at least 25, or at least 35, or at least 45, or 50 or less, or 40 or less, or 30 or less, d) Tensile strength of at least 8 MPa and 15 MPa or less, e.g., at least 9 MPa, or at least 10 MPa, or at least 11 MPa, or at least 12 MPa, or 13 MPa or less, or 12 MPa or less, or 11 MPa or less, or 10 MPa or less, as measured by GB / T 528-2009 Type 1, e) Elongation of at least 200% and 900% or less, e.g., at least 300%, or at least 400%, or at least 500%, or at least 600%, or at least 800%, or 700%, or 600%, or 500% or less, as measured by GB / T 528-2009 Type 1, f) GB / T As measured by 528-2009 Type 1, the first silicone elastomer has a tear strength of at least 10 N / mm and no more than 45 N / mm, for example, at least 15 N / mm, or at least 20 N / mm, or at least 25 N / mm, or at least 30 N / mm, or no more than 40 N / mm, or no more than 35 N / mm, or no more than 30 N / mm, or no more than 35 N / mm, or no more than 30 N / mm, and g) at least one of the Shore A durometers of 30 to 80, for example, 40 to 70, or even 45 to 65, as measured by ASTM D-2240. It will be understood that the properties may be within the range between any of the above minimum and maximum values. In one embodiment, if the base silicone material comprises first and second silicone elastomers, the first silicone elastomer has a smaller number-average molecular weight, weight-average molecular weight, and Mooney viscosity than the second silicone elastomer. In one embodiment, the first silicone elastomer has greater elongation and tear strength than the second silicone elastomer. ,

[0019] In one embodiment, the base silicone material is present in an amount of 50% by weight or more of the total weight of the silicone composition, for example, 50 to 99% by weight, or even more specifically, 90 to 99% by weight. In a more specific embodiment, the base silicone material is present in an amount of at least 55% by weight, or at least 60% by weight, or at least 65% by weight, or at least 70% by weight, or at least 75% by weight, or at least 80% by weight, or at least 85% by weight, or at least 90% by weight, or 99% by weight or less, or 97% by weight or less, or 95% by weight or less, or 93% by weight or less, or 90% by weight or less, or 85% by weight or less, or 80% by weight or less, or 75% by weight or less. In one embodiment, if the base silicone material includes first and second silicone elastomers, the first silicone elastomer is present in an amount of 50% by weight or more of the total weight of the silicone composition, for example, 50 to 90% by weight, or even more specifically, 50 to 80% by weight. In more specific embodiments, the first silicone elastomer is present in an amount of at least 55% by weight, or at least 60% by weight, or at least 65% by weight, or at least 70% by weight, or at least 75% by weight, or at least 80% by weight, or at least 85% by weight, or at least 90% by weight, or 90% by weight or less, or 85% by weight or less, or 80% by weight or less, or 75% by weight or less, or 70% by weight or less, or 65% by weight or less, or 60% by weight or less, or 55% by weight or less, of the total weight of the silicone composition. Furthermore, the second silicone elastomer is present in an amount of 50% by weight or less of the total weight of the silicone composition, for example, 1 to 50% by weight, or even 10 to 40% by weight. In more specific embodiments, the second silicone elastomer is present in an amount of 50% by weight or less, or 45% by weight or less, or 40% by weight or less, or 35% by weight or less, or 30% by weight or less, or 25% by weight or less, or 20% by weight or less, or 15% by weight or less, or at least 1% by weight, or at least 5% by weight, or at least 10% by weight, or at least 15% by weight, or at least 20% by weight, or at least 25% by weight, or at least 30% by weight, or at least 35% by weight, of the total weight of the silicone composition. It will be understood that the amount of silicone elastomer may be within the range between any of the above minimum and maximum values.

[0020] The silicone elastomers of the base silicone material may include conventional commercially prepared silicone formulations. Commercially prepared silicone elastomers typically contain components such as polyorganosiloxanes, catalysts, fillers, and optional additives. Any suitable fillers and additives are assumed. Specific embodiments of commercially available base silicone materials include high-consistency rubber (HCR).

[0021] The silicone composition contains an accelerator. The accelerator is typically a component that may be involved in crosslinking and may affect the chemical structure, properties, etc., of the cured product. Any accelerator is conceivable. Typically, the accelerator includes polyalkylsiloxanes, e.g., silicon hydride-containing polyalkylsiloxanes, vinyl-containing polyalkylsiloxanes, aryl-containing polyalkylsiloxanes, hydroxyl-containing polyalkylsiloxanes, halogen-containing polyalkylsiloxanes, or combinations thereof. In one embodiment, the polyalkylsiloxane may include any alkyl group, e.g., any C1-6 alkyl group, or combinations thereof. In particular, the accelerator is a polyalkylsiloxane different from the polyorganosiloxane of the base silicone material. In one embodiment, the polyalkylsiloxane is terminated with a vinyl group, a methyl group, a hydroxyl group, or a combination thereof. For example, polyalkylsiloxanes include vinyl-terminated polyalkylsiloxanes, trimethyl-terminated polyalkylsiloxanes, hydroxyl-terminated polyalkylsiloxanes, or combinations thereof. In more specific embodiments, the polyalkylsiloxane includes vinyl-terminated polydimethylsiloxane, trimethyl-terminated polydimethylsiloxane, polydimethylsiloxane, polydiethylsiloxane, polydipropylsiloxane, polymethylethylsiloxane, polymethylpropylsiloxane, polymethylhydrosiloxane, polyethylhydrosiloxane, polyphenylsiloxane, polymethylphenylsiloxane, polymethylchlorophenylsiloxane, polyethoxymethylsiloxane, polymethyltrifluoropropylsiloxane, polymethylvinylsiloxane, polymethylhydrosiloxane, or combinations thereof.

[0022] In one embodiment, the accelerator has a weight-average molecular weight of 200,000 g / mol to 1,000,000 g / mol, for example, 200,000 g / mol to 800,000 g / mol, for example, 200,000 g / mol to 600,000 g / mol, for example, 200,000 g / mol to 400,000 g / mol, or even 200,000 g / mol, or even 300,000 g / mol, as measured by GPC in THF. In one embodiment, the polyalkylsiloxane of the accelerator has an aliphatic unsaturated content of at least 0.01% and 5% or less of the polyalkylsiloxane, for example, 1% to 5% by weight, or even about 2% to 4% by weight, as measured by 1H-NMR. In one embodiment, the aliphatic unsaturated content of the polyalkylsiloxane is at least 0.03% by weight, or at least 0.05% by weight, or at least 0.1% by weight, or at least 0.3% by weight, or at least 0.5% by weight, or at least 0.7% by weight, or at least 1% by weight, or at least 2% by weight, or 3% or less by weight, or 1% or less by weight, or 0.7% or less by weight, or 0.5% or less by weight, or 0.3% or less by weight, or 0.1% or less by weight, or 0.05% or less by weight, based on the total weight % of the polyalkylsiloxane as measured by 1H-NMR. The density of the accelerator is at least 0.8 g / cm³ as measured by GB / T 533-2008 Method A. 3 Furthermore, 1.5 g / cm³ 3 The following applies. It will be understood that the value may be within the range of any of the minimum and maximum values ​​listed above.

[0023] For example, the polyalkylsiloxane accelerator may contain halide functional groups, phenyl functional groups, or a combination thereof. For instance, the polyalkylsiloxane may include fluorosilicone or phenylsilicone. Alternatively, the polyalkylsiloxane is nonpolar and does not contain halide functional groups such as chlorine and fluorine, nor phenyl functional groups. Any amount of accelerator is present in the silicone composition. For example, the accelerator may be present in an amount of 0.1% by weight or more of the total weight of the silicone composition, for example, 0.1 to 10% by weight, or even 1 to 5% by weight. In more specific embodiments, the accelerator is present in an amount of at least 0.1% by weight, or at least 0.3% by weight, or at least 0.5% by weight, or at least 0.7% by weight, or at least 1.0% by weight, or at least 1.5% by weight, or at least 2.0% by weight, or at least 2.5% by weight, or 10% by weight or less, or 9.0% by weight or less, or 8.0% by weight or less, or 7.0% by weight or less, or 6.0% by weight or less, or 5.0% by weight or less, or 4.0% by weight or less, or 3.0% by weight or less, based on the total weight of the silicone composition. It will be understood that the amount of the accelerator may be within a range between any of the above minimum and maximum values.

[0024] A curing agent is further included in the silicone composition. The curing agent contains components that can form crosslinked structures with the silicone elastomer. Any reasonable amount of curing agent is assumed. The curing agent is typically a crosslinking agent, e.g., a silicone oil. In certain embodiments, the oil crosslinking agent includes a silicon hydride-containing polyalkylsiloxane such as polymethylhydrosiloxane. The curing agent has a molecular weight of at least 20 mPa.s and no more than 150 mPa.s, for example, 20 mPa.s to 100 mPa.s, or even 30 mPa.s to 50 mPa.s, as measured by HG / T 2363-1992. Furthermore, the curing agent has a hydrogen content (Si-H) of at least 0.01% by weight and 2.0% by weight or less, for example, at least 0.05% by weight, or at least 0.1% by weight, or at least 0.3% by weight, or at least 0.5% by weight, or at least 1% by weight, or 1.5% by weight or less, or 1% by weight or less, or 0.5% by weight or less, or 0.3% by weight or less, as measured by chemical titration HG-T 4658-2014. Any amount of curing agent is present that affects the crosslinking density, curing rate, etc. For example, the curing agent is present in an amount of 0.1% by weight or more of the total weight of the silicone composition, for example, 0.1 to 10% by weight, or even 3 to 8% by weight. In more specific embodiments, the curing agent is present in an amount of at least 0.1% by weight, or at least 0.5% by weight, or at least 1.0% by weight, or at least 1.5% by weight, or at least 2.0% by weight, or at least 2.5% by weight, or at least 3.0% by weight, or at least 3.5% by weight, or 10% by weight or less, or 9.0% by weight or less, or 8.0% by weight or less, or 7.0% by weight or less, or 6.0% by weight or less, or 5.0% by weight or less, or 4.0% by weight or less, or 3.0% by weight or less, based on the total weight of the silicone composition. It will be understood that the value may be within the range between any of the above minimum and maximum values.

[0025] The silicone composition further comprises a catalyst. Typically, the catalyst is present to initiate the crosslinking process. Depending on the silicone composition, any catalyst is envisioned. In one embodiment, a hydrosilylation catalyst can be used. For example, an exemplary hydrosilylation catalyst is an organometallic complex compound of a transition metal. In one embodiment, the catalyst includes platinum, rhodium, ruthenium, etc., or a combination thereof. In a particular embodiment, the catalyst includes platinum. Further optional catalysts may be used in conjunction with the hydrosilylation catalyst. Exemplary optional catalysts may include peroxides, tin, or a combination thereof. In one embodiment, the silicone composition further comprises a peroxide catalyst silicone composition. For example, the catalyst is present in more than 0.1% by weight of the total weight of the silicone composition, for example, 0.1 to 5% by weight, or even 1 to 3% by weight. In more specific embodiments, the catalyst is present in an amount of at least 0.1% by weight, or at least 0.5% by weight, or at least 1.0% by weight, or at least 1.5% by weight, or at least 2.0% by weight, or at least 2.5% by weight, or at least 3.0% by weight, or at least 3.5% by weight, or 5% or less by weight, or 4.5% or less by weight, or 4.0% or less by weight, or 3.5% or less by weight, or 3.0% or less by weight, or 2.5% or less by weight, or 2.0% or less by weight, or 1.5% or less by weight, of the total weight of the silicone composition. It will be understood that the amount of catalyst may be within the range between any of the above minimum and maximum values.

[0026] The silicone composition may further contain additives. Any reasonable additives are assumed. Exemplary additives may include vinyl polymers, methyl polymers, hydrides, adhesion promoters, fillers, initiators, inhibitors, colorants, pigments, carrier materials, antimicrobial agents, or any combination thereof, individually or in combination. In one embodiment, the silicone composition is substantially free of additives, for example, containing less than 0.1% by weight of additives based on the total weight of the silicone composition. In one embodiment, the material content of the peristaltic pump tube is essentially 100% silicone composition. In some embodiments, the silicone composition essentially consists of the respective base silicone materials, accelerators, curing agents, and catalysts described above. When used herein, the phrase “essentially consisting of” in relation to a silicone composition excludes the presence of non-silicone polymers that would affect the basic and novel properties of the silicone composition, although commonly used treatment agents and additives may be used in the silicone composition. In one embodiment, the silicone composition consists of the respective base silicone materials, accelerators, curing agents, and catalysts described above.

[0027] Figure 1 is a diagram of an exemplary article, such as a peristaltic pump tube 100, according to one embodiment. In a particular embodiment, the peristaltic pump tube 100 may include a body 102 having an outer diameter 104 and an inner diameter 106. The inner diameter 106 may form an inner surface 108 of the body 102. The inner surface 108 defines the central lumen of the tube. In addition, the body 102 is shown as a single layer comprising a silicone composition. The layer may include a thickness 110, measured by the difference between the outer diameter 104 and the inner diameter 106.

[0028] In certain embodiments, the outer diameter 104 of the body 102 is approximately 5 mm to approximately 150 mm. It will be understood that the outer diameter 104 may be within the range of any of the above minimum and maximum values. In one embodiment, the inner diameter 106 of the body 102 is approximately 0.1 mm to approximately 100 mm. It will be understood that the inner diameter 106 may be within the range of any of the above minimum and maximum values.

[0029] Furthermore, the body 102 may have a length 112, which is the distance between the distal end 114 and the proximal end 116 of the peristaltic pump 100. In further embodiments, the length 112 of the body 102 may be at least about 2 meters, for example, at least about 5 meters, for example, at least about 10 meters. The length 112 is generally limited by practical issues such as long-length storage and transport, or by customer requirements. Furthermore, the body 102 has a surface 118. The surface 118 may be the outer surface of the tube 100. The surface 118 typically comes into direct contact with the peristaltic pump rollers of the peristaltic pump.

[0030] In the exemplary embodiment shown in Figure 1, the hollow hole 108 perpendicular to the axial direction of the main body 102 has a circular shape, but the cross-section of the hollow hole 108 perpendicular to the axial direction of the main body 102 can have any conceivable cross-sectional shape.

[0031] Although illustrated as a single-layer tube, any number of layers are conceivable. For example, a peristaltic pump tube may contain one, two, three, or even more layers. Typically, the layers have a thickness of at least approximately 0.05 mm to approximately 10 mm. It will be understood that the thickness of the layers may be within the range of any of the above minimum and maximum values. Regardless of the number of layers present, the outer and inner diameters of the peristaltic pump tube can have any of the values ​​defined for the single-layer tube 100 defined in Figure 1. The number of layers depends on the desired final characteristics of the tube.

[0032] In one embodiment, the silicone composition may be formed into a single-layer article, a multilayer article, or laminated, coated, or formed on a substrate. The multilayer article may include layers such as polymer layers, reinforcing layers, adhesive layers, barrier layers, chemical-resistant layers, metal layers, or any combination thereof. If the peristaltic pump tube includes multiple layers, each individual layer of the peristaltic pump tube may be formed by any reasonable means, the means depending on the material and configuration of each individual layer. Any number of layers is also conceivable. Although primarily described as a peristaltic pump tube, the silicone composition can be formed into any useful shape, such as a film, sheet, or tube. The silicone composition may be adhered to or bonded to other substrates containing other polymers.

[0033] In one embodiment, the silicone composition may be formed by any reasonable means depending on the desired final article. In one example, at least one silicone layer is provided by any reasonable means. In one embodiment, at least one silicone layer is formed on a tube by extrusion or injection molding, and then cured by methods such as thermosetting, radiation curing, or a combination thereof.

[0034] In exemplary embodiments, at least one silicone layer is formed by an extrusion molding system. The extrusion molding system for at least one silicone layer typically includes a pumping system and may include several devices that can be used to form at least one silicone layer on a peristaltic pump tube. For example, the extrusion molding system may include a pumping device such as a gear pump, a static mixer, an extruder, a tubular die, a thermosetting device, an radiation curing device, a post-treatment device, or any combination thereof. The method includes receiving the mixed silicone composition described above by the extrusion molding system. Any suitable mixing device is assumed. In particular embodiments, the mixing device forms a homogeneous mixture of the base silicone material, an accelerator, a curing agent, and a catalyst. In one embodiment, heat may be added to the silicone composition. For example, using any suitable heating temperature for the components of the silicone composition may provide a material that can flow from the pumping system and be extruded through a tubular die without degrading the material. For example, the temperature may be about 10°C to about 70°C. It will be understood that the temperature may be within a range between any of the above minimum and maximum values. Typically, the silicone composition is mixed and then pumped through a tubular die in an extrusion molding system, i.e., extruded.

[0035] In alternative embodiments, at least one silicone layer is formed by an injection molding system. The injection molding system includes any pumping system for delivering the silicone composition, such as pneumatic, hydrostatic, gravitational, mechanical, or a combination thereof. The pumping system delivers the silicone composition to a mold configured in any desired shape for a final article, such as a tube. The pumping system may also include any suitable mixing device. In certain embodiments, the mixing device forms a homogeneous mixture of the base silicone material, accelerator, curing agent, and catalyst. Furthermore, the pumping system may include a method for heating any combination of components of the silicone composition to any assumed temperature such that the silicone composition has a desirable viscosity for delivery, allowing it to flow into the mold. The injection molding system may further include a thermosetting device, an radiation curing device, a post-processing device, or any combination thereof.

[0036] In one embodiment, the silicone composition is thermocured. In one embodiment, thermocuring of the silicone composition may involve subjecting the silicone composition to one or more heat sources. In a particular embodiment, the heat source is sufficient to substantially cure the silicone composition. As used herein, “substantially cured” refers to a curing density of 90% to 100%, as determined, for example, by rheometer data (90% curing means that the material reaches 90% of the maximum torque as measured by ASTM D5289). For example, the level of curing is to provide the final peristaltic pump tube with desirable properties.

[0037] In one embodiment, the silicone composition is radiation-cured. Any number of applications of radiation energy may be applied at the same or different wavelengths. For example, an extrusion molding system or an injection molding system may include one or more ovens (e.g., infrared (IR) ovens, air ovens), one or more baths (e.g., water baths), or a combination thereof, to cure the silicone composition. One or more IR ovens may be operated at specific peak wavelengths. In a particular example, the peak wavelength of a first IR oven may differ from the peak wavelength of a second IR oven. In one embodiment, the silicone composition may be subjected to heat treatment for a specific period. In a particular embodiment, the silicone composition may be cured in a first IR oven for a first period, and then cured in a second IR oven for a second period different from the first period. In a particular embodiment, a short-wavelength IR oven is used. Short wavelength means that the peak wavelength is less than 4 microns, typically less than 3 microns, for example, in the range of about 0.6 to 2.0 microns, for example, 0.8 to 1.8 microns. Generally, mid-wavelength and long-wavelength IR ovens are characterized by peak wavelengths of approximately 4–8 microns, or even greater. It will be understood that the wavelength can be within the range of any of the minimum and maximum values ​​mentioned above.

[0038] Once the silicone composition is formed, it can undergo one or more post-treatment operations. Any reasonable post-treatment operation is conceivable. For example, the silicone composition can be subjected to a post-curing heat treatment, such as a post-curing cycle. The post-heat treatment is typically carried out at a temperature of about 40°C to about 200°C. In one embodiment, the post-heat treatment is at a temperature of about 60°C to about 100°C. Typically, the post-heat treatment is carried out over a period of about 5 minutes to about 10 hours, for example, about 10 minutes to about 30 minutes, or alternatively, about 1 hour to about 4 hours. It will be understood that the post-heat treatment temperature and time may be within a range between any of the minimum and maximum values ​​above. In an alternative example, the silicone composition is not subjected to post-heat treatment. In one example, the silicone article is a tube that can be cut into several peristaltic pump tubes having a specific length. In another embodiment, the post-treatment may include winding the peristaltic pump tubes onto a coil of tubing material.

[0039] Peristaltic pump tubing can be sterilized. In one embodiment, peristaltic pump tubing can be sterilized by any conceivable method. For example, peristaltic pump tubing is sterilized after formation. Exemplary sterilization methods include steam, gamma rays, ethylene oxide, electron beam technology, and combinations thereof. In certain embodiments, peristaltic pump tubing is sterilized by gamma irradiation. For example, peristaltic pump tubing can be gamma-sterilized at approximately 10 kGy to approximately 200 kGy. In certain embodiments, peristaltic pump tubing is sterilized by steam sterilization. In an exemplary embodiment, peristaltic pump tubing is heat-resistant to steam sterilization at temperatures up to approximately 130°C for approximately 45 minutes. In one embodiment, peristaltic pump tubing is heat-resistant to steam sterilization at temperatures up to approximately 135°C for approximately 15 minutes. It will be understood that sterilization parameters may be within the range between any of the minimum and maximum values ​​described above.

[0040] In one embodiment, the peristaltic pump tube has advantageous properties. For example, the peristaltic pump tube has a desirable lifespan when used at high-speed pumping applications, such as speeds exceeding 600 revolutions per minute (rpm), or at least 700 rpm, or at least 750 rpm, or at least 800 rpm, or at least 850 rpm, or at least 900 rpm. For example, the peristaltic pump tube has a tube lifespan of at least 100 hours, or at least 120 hours, or at least 140 hours, or at least 160 hours, or at least 180 hours, or at least 200 hours at 700 rpm using a pump head test with distilled water. In one embodiment, the peristaltic pump tube has a tube lifespan of at least 70 hours, or at least 80 hours, or at least 90 hours, or at least 100 hours, or at least 110 hours, or at least 120 hours at 900 rpm using a pump head test with distilled water. In one embodiment, the peristaltic pump tube has a flow consistency (R 2 ) of at least 0.95, or at least 0.97, or at least 0.99 in a pumping speed range of 100 rpm to 900 rpm. In yet another embodiment, the peristaltic pump tube has a flow rate drop of 20% or less, or at most 18%, or at most 16%, or at most 14%, or at most 12%, or at most 10% before failure. An illustration of an exemplary peristaltic pump for testing is described in the examples.

[0041] In one embodiment, the resulting peristaltic pump tube may have more desirable physical and mechanical properties. For example, the peristaltic pump tube may be flexible and torsion resistant. In particular, the resulting peristaltic pump tube may have desirable flexibility. For example, a silicone composition may favorably produce low durometer articles. For example, it may form a peristaltic pump tube having a Shore A durometer of about 20 to about 90, such as about 35 to about 75, as measured by ASTM D-2240, which has desirable mechanical properties. Such properties indicate a flexible material.In one embodiment, the peristaltic pump tube has the following characteristics: a) a burst pressure of 0.2 MPa to 1.0 MPa, for example, at least 0.3 MPa, or at least 0.4 MPa, or at least 0.5 MPa, or at least 0.6 MPa, or 0.9 MPa or less, or 0.8 MPa or less, or 0.7 MPa or less, or 0.6 MPa or less; b) a tear strength of 30 N / mm to 55 N / mm, for example, at least 35 N / mm, or at least 40 N / mm, or at least 45 N / mm, or 45 N / mm or less, or 40 N / mm or less, or 35 N / mm or less, as measured by ASTM D624 (Die B); c) ASTM d) Elongation of 300% to 800%, as measured by D412 (Die C), for example, at least 350%, or at least 400%, or at least 450%, or at least 500%, or at least 550%, or at least 600%, or 750%, or 700%, or 650%, or 600%, or 550%, or 500%, or 450%, d) Tensile strength of 5 MPa to 10 MPa, as measured by ASTM D412 (Die C), for example, at least 6 MPa, or at least 7 MPa, or at least 8 MPa, or 9 MPa, or 8 MPa, or 7 MPa, e) Compression set of 10% to 40%, as measured by ISO 815-1, for example, at least 15%, or at least 20%, or at least 25%, or 35%, or 30%, or 25%, and f) ISO As measured by 4662, it has at least one of the following rebound elasticity values: 30% to 70%, for example, at least 35%, or at least 40%, or at least 45%, or at least 50%, or 65% or less, or 60% or less, or 55% or less, or 50% or less. It will be understood that the value may be within the range between any of the above minimum and maximum values.

[0042] Furthermore, peristaltic pump tubes may possess advantageous properties such as compression hysteresis, tensile strength, elongation, fracture energy, compression set, burst pressure, or a combination thereof. For example, a peristaltic pump tube may have a compression hysteresis loss of less than 40% over 100,000 to 400,000 cycles at a frequency of 20 Hz and a strain range of 20%. In one embodiment, a peristaltic pump tube may have at least one of the following properties at room temperature, as measured by ASTM D1708: a) tensile strength of 5.5 MPa to 9.5 MPa, b) elongation of 350% to 600%, c) fracture energy greater than 2000 N·mm, or a combination thereof. In one embodiment, the peristaltic pump tube may have at least one of the following characteristics at 60°C, as measured by ASTM D1708: a) tensile strength of 5.5 MPa to 9.5 MPa, b) elongation of 275% to 500%, c) breaking energy greater than 2000 N·mm, or a combination thereof. In yet another embodiment, the peristaltic pump tube may have at least one of the following characteristics at 60°C, as measured in a notched tensile test at a tensile speed of 50 mm / min: a) tensile strength of 15 MPa to 50 MPa, b) breaking elongation greater than 400%, c) breaking energy of at least 500 N·mm, d) nonlinear fracture at rupture, or a combination thereof. Additionally, the peristaltic pump tube may have a burst pressure greater than 4.75 bar, or greater than 4.8 bar, or even greater than 4.9 bar, as measured by ASTM D1599. In yet another embodiment, the peristaltic pump tube may have a compression set of 4.8% to 5.2%.

[0043] In exemplary embodiments, peristaltic pump tubing can be used in a variety of applications. There are numerous applications for peristaltic pump tubing. In particular, the non-toxic properties of the silicone composition make this peristaltic pump tubing useful for any application where toxicity is undesirable. For example, peristaltic pump tubing may be approved under the FDA, ADCF, USP Class VI, NSF, European Pharmacopoeia, United States Pharmacopoeia (USP), USP Physiological and Chemical, ISO 10993 standard for evaluating the biocompatibility of medical devices, and other regulations. In specific embodiments, the silicone composition may be non-cytotoxic, non-hemolytic, non-pyrogenic, free of animal-derived components, non-mutagenic, non-bacteriostatic, non-fungal, or any combination of these properties.

[0044] In one embodiment, the silicone composition may be optionally formed into any suitable article, such as a peristaltic pump tube, which can be used in applications such as industrial, medical, healthcare, biopharmaceutical, drinking water, food and beverage, dairy, laboratory, FDA, and laboratory applications. In exemplary embodiments, the article is described primarily as a peristaltic pump tube, but the article of the present invention may include any conceivable tube, connector, molded part, partition, injection sleeve, pump diaphragm, valve, etc. Any article for which the physical and mechanical properties of the silicone composition are advantageous is conceivable.

[0045] Many different aspects and embodiments are possible. Some of these aspects and embodiments are described herein. After reading this specification, those skilled in the art will understand that these aspects and embodiments are illustrative only and do not limit the scope of the invention. Embodiments may be in accordance with one or more of the items listed below.

[0046] Embodiment 1. A peristaltic pump tube comprising a silicone composition comprising a base silicone material, an accelerator, a curing agent, and a catalyst, wherein the base silicone material comprises a blend of a first silicone elastomer and a second silicone elastomer, the first silicone elastomer having a Shore A durometer different from that of the second silicone elastomer, and the peristaltic pump tube being used with a peristaltic pump at a rotor speed exceeding 600 revolutions per minute (rpm).

[0047] Embodiment 2. A method for forming a peristaltic pump tube, comprising mixing a silicone composition comprising a base silicone material, an accelerator, a curing agent, and a catalyst, wherein the base silicone material comprises a blend of a first silicone elastomer and a second silicone elastomer, the first silicone elastomer having a Shore A durometer different from that of the second silicone elastomer, and forming the composition into at least one layer, wherein the peristaltic pump tube is used with a peristaltic pump at a rotor speed exceeding 600 revolutions per minute (rpm).

[0048] Embodiment 3. A method for forming a peristaltic pump tube according to Embodiment 1 or 2, wherein the first silicone elastomer and the second silicone elastomer contain a polyorganosiloxane.

[0049] Embodiment 4. A method for forming a peristaltic pump tube according to Embodiment 3, wherein the polyorganosiloxane comprises a silicon hydride-containing polyalkylsiloxane, a vinyl-containing polyalkylsiloxane, an aryl-containing polyalkylsiloxane, a hydroxyl-containing polyalkylsiloxane, a halogen-containing polyalkylsiloxane, or a combination thereof.

[0050] Embodiment 5. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 4, wherein the first silicone elastomer has a Shore A durometer of 50 or less, for example, 20 to 50, for example, 30 to 50, or even 35 to 45.

[0051] Embodiment 6. A peristaltic pump tube or a method for forming a peristaltic pump tube according to Embodiment 5, wherein the first silicone elastomer is present in an amount of 50% by weight or more, for example, 50 to 90% by weight, or even 50 to 80% by weight, of the total weight of the silicone composition.

[0052] Embodiment 7. A method for forming a peristaltic pump tube according to any one of Embodiments 1 to 6, wherein the second silicone elastomer has a Shore A durometer of 50 or more, for example, 50 to 80, for example, 60 to 80, or even 65 to 75.

[0053] Embodiment 8. A peristaltic pump tube or a method for forming a peristaltic pump tube according to Embodiment 7, wherein the second silicone elastomer is present in an amount of 50% by weight or less of the total weight of the silicone composition, for example, 1 to 50% by weight, or even 10 to 40% by weight.

[0054] Embodiment 9. A method for forming a peristaltic pump tube according to any one of Embodiments 1 to 8, wherein the base silicone material has a Shore A durometer of 30 to 80, for example, 40 to 70, or even 45 to 65.

[0055] Embodiment 10. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 9, wherein the base silicone material has a number average molecular weight of 200,000 g / mol to 1,000,000 g / mol.

[0056] Embodiment 11. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 10, wherein the base silicone material has a weight-average molecular weight of 200,000 g / mol to 1,000,000 g / mol.

[0057] Embodiment 12. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 11, wherein the accelerator comprises a polyalkylsiloxane.

[0058] Embodiment 13. A method for forming a peristaltic pump tube according to Embodiment 12, wherein the polyalkylsiloxane comprises a vinyl-terminated polyalkylsiloxane, a trimethyl-terminated polyalkylsiloxane, a hydroxy-terminated polyalkylsiloxane, or a combination thereof.

[0059] Embodiment 14. A peristaltic pump tube or a method for forming a peristaltic pump tube according to Embodiment 12, wherein the accelerator has a weight-average molecular weight of 200,000 g / mol to 1,000,000 g / mol.

[0060] Embodiment 15. The peristaltic pump tube or method for forming a peristaltic pump tube according to Embodiment 12, wherein the accelerator is present in an amount of 0.1% by weight or more of the total weight of the silicone composition, for example, 0.1 to 10% by weight, or even 1 to 5% by weight.

[0061] Embodiment 16. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 15, wherein the curing agent comprises a silicon hydride-containing polyalkylsiloxane.

[0062] Embodiment 17. A method for forming a peristaltic pump tube according to Embodiment 16, wherein the silicon hydride-containing polyalkylsiloxane contains polymethylhydrosiloxane.

[0063] Embodiment 18. A peristaltic pump tube or a method for forming a peristaltic pump tube according to Embodiment 16, wherein the curing agent is present in an amount of 0.1% by weight or more of the total weight of the silicone composition, for example, 0.1 to 10% by weight, or even more than 3 to 8% by weight.

[0064] Embodiment 19. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 18, wherein the catalyst comprises a hydrosilylation reaction catalyst.

[0065] Embodiment 20. The peristaltic pump tube or method for forming a peristaltic pump tube according to Embodiment 19, wherein the hydrosilylation reaction catalyst comprises a platinum catalyst, a rhodium catalyst, a ruthenium catalyst, or a combination thereof.

[0066] Embodiment 21. A peristaltic pump tube or a method for forming a peristaltic pump tube according to Embodiment 19, wherein the catalyst is present in an amount of 0.1% by weight or more of the total weight of the silicone composition, for example, 0.1 to 5% by weight, or even 1 to 3% by weight.

[0067] Embodiment 22. A peristaltic pump tube according to any one of Embodiments 1 to 21, or a method for forming a peristaltic pump tube, wherein the peristaltic pump tube has an inner surface that defines the central lumen of the tube.

[0068] Embodiment 23. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 22, having a compression hysteresis loss of less than 40% over 100,000 to 400,000 cycles at a frequency of 20 Hz and a 20% distortion range.

[0069] Embodiment 24. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 23, having at least one of the following properties at room temperature, as measured by ASTM D1708: a) tensile strength of 5.5 MPa to 9.5 MPa, b) elongation of 350% to 600%, c) breaking energy greater than 2000 N·mm, or a combination thereof.

[0070] Embodiment 25. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 24, having at least one of the following properties at 60°C as measured by ASTM D1708: a) tensile strength of 5.5 MPa to 9.5 MPa, b) elongation of 275% to 500%, c) breaking energy greater than 2000 N·mm, or a combination thereof.

[0071] Embodiment 26. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 25, having at least one of the following characteristics in a notched tensile test at 60°C, measured at a tensile speed of 50 mm / min: a) tensile strength of 15 MPa to 50 MPa, b) elongation at break of more than 400%, c) energy at break of at least 500 N·mm, d) nonlinear fracture, or a combination thereof.

[0072] Embodiment 27. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 26, having a burst pressure greater than 4.75 bar, greater than 4.8 bar, or even greater than 4.9 bar, as measured by ASTM D1599.

[0073] Embodiment 28.4. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 27, having a compression set of 8% to 5.2%.

[0074] Embodiment 29. A peristaltic pump tube according to any one of Embodiments 1 to 28, or a method for forming a peristaltic pump tube, wherein the peristaltic pump tube has a tube life of at least 100 hours at 700 rpm using a pump head test with distilled water.

[0075] Embodiment 30. A peristaltic pump tube according to any one of Embodiments 1 to 29, or a method for forming a peristaltic pump tube, wherein the peristaltic pump tube has a tube life of at least 70 hours at 900 rpm using a pump head test with distilled water.

[0076] Embodiment 31. The peristaltic pump tube has a flow rate consistency of at least 0.95 (R) in the pumping speed range of 100 rpm to 900 rpm. 2 A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of embodiments 1 to 30, having ).

[0077] Embodiment 32. A peristaltic pump tube according to any one of Embodiments 1 to 31, or a method for forming a peristaltic pump tube, wherein the peristaltic pump tube has a flow rate reduction of 20% or less before failure.

[0078] Embodiment 33. A peristaltic pump tube according to any one of Embodiments 1 to 32, or a method for forming a peristaltic pump tube, wherein the peristaltic pump tube has a burst pressure of 0.2 MPa to 1.0 MPa.

[0079] Embodiment 34. A peristaltic pump tube according to any one of Embodiments 1 to 33, or a method for forming a peristaltic pump tube, wherein the peristaltic pump tube has a tear strength of 30 N / mm to 55 N / mm as measured by ASTM D624 (Die B).

[0080] Embodiment 35. A peristaltic pump tube according to any one of Embodiments 1 to 34, or a method for forming a peristaltic pump tube, wherein the peristaltic pump tube has an elongation of 300% to 800 as measured by ASTM D412 (Die C).

[0081] Embodiment 36. A peristaltic pump tube according to any one of Embodiments 1 to 35, or a method for forming a peristaltic pump tube, wherein the peristaltic pump tube has a tensile strength of 5 MPa to 10 MPa as measured by ASTM D412 (Die C).

[0082] Embodiment 37. A peristaltic pump tube according to any one of Embodiments 1 to 36, or a method for forming a peristaltic pump tube, wherein the peristaltic pump tube has a compression set of 10% to 40% as measured by ISO 815-1.

[0083] Embodiment 38. A peristaltic pump tube or a method for forming a peristaltic pump tube according to any one of Embodiments 1 to 37, having an inner diameter of approximately 0.1 mm to approximately 100 mm.

[0084] Embodiment 39. A peristaltic pump tube according to Embodiment 38, or a method for forming a peristaltic pump tube, having an outer diameter of approximately 5 mm to approximately 150 mm.

[0085] Embodiment 40. A method for forming a peristaltic pump tube according to Embodiments 2 to 39, further comprising curing the peristaltic pump tube.

[0086] Embodiment 41. A method for forming a peristaltic pump tube according to Embodiment 40, wherein the cured tube has a crosslinking density of 90% to 100%.

[0087] Embodiment 42. Peristaltic pump tube, wherein the peristaltic pump tube comprises a silicone composition comprising a base silicone material, an accelerator, a curing agent, and a catalyst, the base silicone material comprising a blend of a first silicone elastomer and a second silicone elastomer, the first silicone elastomer having a Shore A durometer different from that of the second silicone elastomer, and the peristaltic pump tube having the following characteristics: a) total fragmentation by particles of size >2 μm, less than 5 particles / mL, e.g., less than 4 particles / mL, e.g., less than 3 particles / mL, e.g., less than 2 particles / mL, when pumped in a peristaltic pump at 300 rpm using distilled water, after filling 1000 vials, or b) 1000 μm 2 Less than / mL, for example, 800μm 2 Less than / mL, e.g., 600μm 2Less than / mL, for example, 400μm 2 Less than / mL, for example, 200μm 2 Total crushing area less than / mL (μm 2 A peristaltic pump tube having at least one of the following ( / mL).

[0088] The concepts described herein are further illustrated in the following examples, but are not intended to limit the scope of the disclosure as defined in the claims. The following examples are provided to better disclose and teach the methods and compositions of the present invention. It should be recognized that they are for illustrative purposes only and that minor modifications and changes can be made without substantially affecting the spirit and scope of the invention as defined in the appended claims. [Examples]

[0089] The following components are provided to form a silicone composition: (A) Component, base silicone material - first silicone elastomer A-1: Polyorganosiloxane with a hardness of 40 duro. The tensile strength and elongation of A-1 were 8-10 MPa and 700-800%, respectively. The tear strength of A-1 was 25-40 N / mm. The vinyl content in the polyorganosiloxane was 0.05-0.15% by weight. A-2 (comparative) is a polyorganosiloxane with a hardness of 40 duro. The tensile strength and elongation of A-2 were 8.5-10 MPa and 700-800%, respectively. The tear strength of A-2 was 10-20 N / mm. The vinyl content in the polyorganosiloxane was 0.01-0.05% by weight.

[0090] (B) Component, base silicone material - second silicone elastomer B-1: Polyorganosiloxane with a hardness of 70 duro. The tensile strength and elongation of B-1 were 9-12 MPa and 300-450%, respectively. The tear strength of B-1 was 15-30 N / mm. The vinyl content in the polyorganosiloxane was 0.20-1.0% by weight. B-2 (comparison): Polyalkylsiloxane with a hardness of 40 duro. The tensile strength and elongation of B-2 were 8-10 MPa and 400-500%, respectively. The tear strength of B-2 was 25-40 N / mm. The vinyl content in the polyalkylsiloxane was 0.01-0.20 wt%.

[0091] (C) Ingredients, accelerators C-1: A vinyl-containing polyalkylsiloxane with a vinyl content of 1-5% by weight. C-2 (Comparison): Vinyl-containing polyalkylsiloxane with a vinyl content of 1-5% by weight.

[0092] (D) Components, hardener D-1: Polymethylhydrosiloxane (PMHS) containing 0.03-0.40% by weight of Si-H. D-2 (comparison): Same as D-1, PMHS containing 0.03-0.04% by weight of Si-H.

[0093] (E) Component, catalyst E-1: Platinum catalyst system with a Pt atom content of 0.03 to 0.05% by weight. E-2 (Comparison): Platinum catalyst with the same Pt ​​atom content as E-1, but with a Pt atom content of 0.03-0.05 wt%. (ICS-OES)

[0094] The compositions of the examples and comparative examples are prepared by mixing the above components (A) to (E) in the amounts shown in Table 1.

[0095] [Table 1]

[0096] Two silicone pipe materials were extruded according to the compositions of Example 1 and Comparative Example 1 shown in Table 1.

[0097] Test results from both laboratory tests (Figure 2) and field tests (Table 2) showed that the new silicone tubing material (Example 1) exhibited a longer tubing life at high pump speeds compared to Comparative Example 1 of the tubing material.

[0098] [Table 2]

[0099] The pump's characteristics were as follows: The peristaltic pump included a pump case, a rotating disk with four copper rollers, and a drive motor. The diameter of the rotating disk was 56 ± 0.2 mm. The four rollers were distributed on the disk at a 90-degree ram, and the diameter of the rollers was 8.9 ± 0.1 mm. The minimum distance between the rollers and the pump case was 5 ± 0.1 mm. The rotating disk speed could be adjusted within the range of 100 to 1000 rpm.

[0100] Description of Test Method: The pump life of tubing (14.8 mm (OD) and 8.8 mm (ID)) was tested using the pump head defined above, with distilled water as the medium, under different rotor speeds. For example, tubing pump life was tested under 700 rpm and 900 rpm to determine tubing life. Tube life was defined as the total operating time at which water leakage was observed or the flow rate reduction exceeded 25%. A comparison of the tubing life of an exemplary peristaltic pump tube and a comparison tube when tested at 900 rpm can be seen in Figure 2.

[0101] Furthermore, to determine the flow rate, it was calculated by measuring the mass of water pumped and discharged by the pipe per unit time under a specific pumping speed. The flow rates of the pipe were tested at 100, 300, 500, 700, and 900 rpm. The flow rate (g / min) was plotted against the pump speed (rpm), and a linear relationship was calculated. The linear equation R 2The flow consistency of the pipe material under different pump speeds was determined using the following method, which can be seen in Figure 3. Flow rate reduction was calculated by measuring the mass of water pumped out by the pipe material per unit time under a specific pumping speed. Flow rate reduction was determined by measuring the initial and final measured flow rates under the same pump speed. Flow rate reduction was calculated using the following formula: Flow rate drop = (1-final flow rate / initial flow rate) * 100%

[0102] Crosslink density The crosslink density (V) and the critical molecular weight (Mc) between crosslinks were measured by the change in weight of the sample after swelling in toluene solvent. The sample was then removed from the solution and placed in a pre-weighed sealed container to obtain its weight after swelling. The crosslink density was calculated using the Florey-Léner formula. In one embodiment, the crosslink density of the exemplary silicone composition was 90%–100%, as measured by the described test method.

[0103] Burst pressure test: The burst pressure test was performed according to ASTM D1599 by continuously increasing the internal water pressure of an exemplary pipe material having an ID of 0.250 inches and an OD of 0.375 inches while immersing it at a controlled temperature. A comparative commercially available tube having an ID of 0.250 inches and an OD of 0.375 inches was also tested. Specifically, the data presented were obtained by immersing the pipe material in a water bath at ambient temperature. The highest pressure value during the test on the pressure indicator system constituted the pipe material burst pressure value. At least three repeated tests were performed for each pipe material to determine the burst pressure. The results can be seen in Table 3.

[0104] [Table 3]

[0105] As shown in Table 3, the average burst pressure of the example pipe was higher than that of the comparison tube.

[0106] Compression fatigue Exemplary and comparative commercially available tubing (both with dimensions of ID 0.250 inches and OD 0.375 inches) were tested. Samples were prepared by cutting a 5 cm length of tubing, then cutting the tubing along its longitudinal direction to a width of 26 mm, and then placing the cut tubing flat in the testing machine with a sample size of 26 mm width and 50 mm length. Periodic compression tests were performed on an Instron 8801 fatigue testing machine with a 20% strain range, 400,000 cycles, and a frequency of 20 Hz. Hysteresis results measured from compression fatigue showed the relative hysteresis loss of the exemplary tubing compared to the comparative tube. The results can be seen in Figure 4. As seen in the figure, the exemplary tubing had lower relative hysteresis after 10,000 cycles.

[0107] Tensile test Tensile tests were performed on an Instron 3367 tensile testing machine according to ASTM D1708. The speed was 50 mm / min, and samples were cut from exemplary tubing (ID 0.250 inches and OD 0.375 inches) and comparative commercially available tubing (ID 0.250 inches and OD 0.375 inches). Tests were performed at room temperature (RT) and 60°C between the exemplary and comparative tubing. The results can be seen in Table 4.

[0108] [Table 4]

[0109] The fracture energies of the exemplary pipe material at room temperature and 60°C were both higher than those of the comparative pipe material. For the silicone polymer, longer elongations indicate better elasticity of the polymer chains, which is beneficial for decentralizing stress at the crack tip.

[0110] Tensile notch test - Crack propagation Tensile tests were performed on an Instron 3367 tensile testing machine according to ASTM D1708. The speed was 50 mm / min, and samples were cut from exemplary tubing (ID 0.250 inches and OD 0.375 inches) and commercially available tubing for comparison (ID 0.250 inches and OD 0.375 inches). Samples were prepared by cutting 4.5 cm in length, then cutting the tubing along its longitudinal direction to a width of 26 mm, and then placing the cut tubing flat in the testing machine with a sample size of 26 mm in width and 45 mm in length. A 3 mm long notch was pre-formed in the samples using a blade. Tests were performed at room temperature (RT) and 60°C between exemplary and comparison tubing. The results can be seen in Table 5.

[0111] [Table 5]

[0112] The tensile strength in the table represents the maximum tensile strength value in the stress-stress curve of this tensile notch test. The fracture energy is the fracture toughness calculated from the values ​​in the full region of the stress-strain curve.

[0113] The results clearly demonstrate that the exemplary tube exhibited higher crack propagation resistance than the commercially available tube under tensile notch testing at 60°C. In particular, as seen in Figures 5A and 5B, the exemplary tube exhibited nonlinear fracture (i.e., a jagged crack) across the width of the sample at 60°C (Figure 5B), compared to the commercially available tube (Figure 5A), which exhibited linear fracture (i.e., a straight crack) across the width of the sample at 60°C.

[0114] Pipe Compression Test Exemplary tubes and commercially available reference tubes were tested for compression set. The test included measuring the wall thickness of the tube material by optical microscope prior to the compression set test. Each tube (ID 0.250 inches and OD 0.375 inches) was placed in a compression fixture (ISO 815). The distance between the two plates of the fixture was set to 2.4 mm (25% compression), and the tubes were pressed in an oven at 175°C for 22 hours. The wall thickness after compression was then measured via optical microscope. The compression set (C-set) value was calculated using the wall thickness values ​​before and after compression. The results can be seen in Table 6.

[0115] [Table 6]

[0116] The compression set showed no significant difference between the example tube and the comparison tube.

[0117] Crushing The fragmentation measurement method involves counting the particles detached from the tube after 1,000 cycles in the recirculating fluid. The exemplary tube has an ID of 1.6 mm and an OD of 4.8 mm. 25 mL of ultrapure water is passed through a FlowCam® 8000 Imaging Flow Cytometer (IFC) as a blank. The tube is loaded into a Flexicon® PF7 pump. The first three 1.8 mL vial contents are discarded to rinse the tube for contaminants. The test is performed without using a needle on the end of the tube. 100 mL of water is recirculated through the pump at 300 rpm for 1,000 cycles. The entire flask of 100 mL of recirculated (pumped) water is sampled through the IFC at a rate of 5 mL / min and a magnification of 4x. This is repeated 1,000 times, then another 1,000 times, each time using a new 100 mL of ultrapure water. The IFC samples the entire fluid pumped during the first 1,000 cycles, the second 1,000 cycles, and the third 1,000 cycles of vial filling. The tubing is not touched throughout the entire test, completing all 3,000 cycles of vial filling.

[0118] Fragmentation (or particle shedding) typically results from shear compressive forces in peristaltic pumps, which cause the release of particles from the tubing. Fragmentation is measured by particles / mL (how many larger particles detach from the tube in the amount of fluid being recirculated) and total fragmentation area / mL (μm²). 2 This is expressed as ( / mL). These two parameters indicate both the total particles produced in the fluid path by the tubing material and the relative size of the particles. Fewer particles and a smaller total area are desirable. The tubing material is tested both unirradiated and after gamma irradiation of approximately 42 kGy.

[0119] An exemplary, unirradiated peristaltic pump tubing material has total fragmentation by particles >2 μm in size with a density of less than 5 particles / mL, e.g., less than 4 particles / mL, e.g., less than 3 particles / mL, e.g., less than 2 particles / mL, after 1000 vial fillings. In one embodiment, an exemplary, unirradiated peristaltic pump tubing material has total fragmentation by particles >2 μm in size with a density of less than 5 particles / mL, e.g., less than 4 particles / mL, e.g., less than 3 particles / mL, e.g., less than 2 particles / mL, after 2000 vial fillings. In one embodiment, an exemplary, unirradiated peristaltic pump tubing material has total fragmentation by particles >2 μm in size with a density of less than 5 particles / mL, e.g., less than 4 particles / mL, e.g., less than 3 particles / mL, e.g., less than 2 particles / mL, after 3000 vial fillings.

[0120] An example of an unirradiated peristaltic pump tube shows a 1000 μm difference after 1000 vial fillings. 2 Less than / mL, for example, 800μm 2 Less than / mL, e.g., 600μm 2 Less than / mL, for example, 400μm 2 Less than / mL, for example, 200μm 2 Total crushing area less than / mL (μm 2 It has ( / mL). In one embodiment, an exemplary peristaltic pump tube that has not been irradiated has 1000 μm after 2000 vial fillings. 2 Less than / mL, for example, 800μm 2 Less than / mL, e.g., 600μm 2 Less than / mL, for example, 400μm 2 Less than / mL, for example, 200μm 2 Total crushing area less than / mL (μm 2 It has ( / mL). In one embodiment, an exemplary peristaltic pump tube that has not been irradiated has 1000 μm after 3000 vial fillings. 2 Less than / mL, for example, 800μm 2 Less than / mL, e.g., 600μm 2 Less than / mL, for example, 400μm 2 Less than / mL, for example, 200μm 2 Total crushing area less than / mL (μm 2 It has ( / mL)

[0121] An exemplary peristaltic pump tubing material to be irradiated has total fragmentation by particles >2 μm in size with a density of less than 50 particles / mL, e.g., less than 40 particles / mL, e.g., less than 30 particles / mL, e.g., less than 20 particles / mL, after 1000 vial fillings. In one embodiment, an exemplary peristaltic pump tubing material to be irradiated has total fragmentation by particles >2 μm in size with a density of less than 50 particles / mL, e.g., less than 40 particles / mL, e.g., less than 30 particles / mL, e.g., less than 20 particles / mL, after 2000 vial fillings. In one embodiment, an exemplary peristaltic pump tubing material to be irradiated has total fragmentation by particles >2 μm in size with a density of less than 50 particles / mL, e.g., less than 40 particles / mL, e.g., less than 30 particles / mL, e.g., less than 20 particles / mL, after 3000 vial fillings.

[0122] The example peristaltic pump tubing being irradiated has a 2000 μm filtration rate after 1000 vial fillings. 2 Less than / mL, for example, 1800μm 2 Less than / mL, for example, 1600μm 2 Less than / mL, e.g., 1400μm 2 Less than / mL, e.g., 1200μm 2 Less than / mL, for example, 1000μm 2 Total crushing area less than / mL (μm 2 It has ( / mL). In one embodiment, the exemplary peristaltic pump tube material to be irradiated is 2000 μm after 2000 vial fillings. 2 Less than / mL, for example, 1800μm 2 Less than / mL, for example, 1600μm 2 Less than / mL, e.g., 1400μm 2 Less than / mL, e.g., 1200μm 2 Less than / mL, for example, 1000μm 2 Total crushing area less than / mL (μm 2 It has ( / mL). In one embodiment, the exemplary peristaltic pump tube material to be irradiated is 2000 μm after 3000 vial fillings. 2 Less than / mL, for example, 1800μm 2 Less than / mL, for example, 1600μm2 Less than / mL, e.g., 1400μm 2 Less than / mL, e.g., 1200μm 2 Less than / mL, for example, 1000μm 2 Total crushing area less than / mL (μm 2 It has ( / mL)

[0123] The aforementioned specification has described the concept with reference to specific embodiments. However, those skilled in the art will understand that various modifications and changes can be made without departing from the scope of the invention as set forth in the following claims. Therefore, the specification and drawings should be considered illustrative rather than restrictive, and all such modifications are intended to fall within the scope of the invention.

[0124] Benefits, other advantages, and solutions to problems are described above in relation to specific embodiments. However, benefits, advantages, solutions to problems, and any features that may result in or enhance any benefit, advantage, or solution should not be construed as essential, necessary, or intrinsic features of any or all of the claims.

[0125] After reading this specification, those skilled in the art will understand that certain features are described herein in the context of separate embodiments for clarity and may be provided in combination in a single embodiment. Conversely, for brevity, various features described in the context of a single embodiment may be provided separately or in any partial combination. Furthermore, references to values ​​stated in ranges include all values ​​within that range.

Claims

1. A peristaltic pump tube comprising a silicone composition comprising a base silicone material, an accelerator, a curing agent, and a catalyst, wherein the base silicone material comprises a blend of a first silicone elastomer and a second silicone elastomer, the first silicone elastomer having a Shore A durometer different from that of the second silicone elastomer, and the peristaltic pump tube being used with a peristaltic pump at a rotor speed exceeding 600 revolutions per minute (rpm).

2. The peristaltic pump tube according to claim 1, wherein the first silicone elastomer and the second silicone elastomer contain a polyorganosiloxane.

3. The peristaltic pump tube according to claim 2, wherein the polyorganosiloxane includes a silicon hydride-containing polyalkylsiloxane, a vinyl-containing polyalkylsiloxane, an aryl-containing polyalkylsiloxane, a hydroxyl-containing polyalkylsiloxane, a halogen-containing polyalkylsiloxane, or a combination thereof.

4. The peristaltic pump tube according to claim 1, wherein the first silicone elastomer has a Shore A durometer of 50 or less, for example, 20 to 50, for example, 30 to 50, or even 35 to 45.

5. The peristaltic pump tube according to claim 4, wherein the first silicone elastomer is present in an amount of 50% by weight or more of the total weight of the silicone composition, for example, 50 to 90% by weight, or even more precisely, 50 to 80% by weight.

6. The peristaltic pump tube according to claim 1, wherein the second silicone elastomer has a Shore A durometer of 50 or more, for example, 50 to 80, for example, 60 to 80, or even 65 to 75.

7. The peristaltic pump tube according to claim 6, wherein the second silicone elastomer is present in an amount of 50% by weight or less of the total weight of the silicone composition, for example, 1 to 50% by weight, or more precisely, 10 to 40% by weight.

8. The peristaltic pump tube according to claim 1, wherein the base silicone material has a Shore A durometer of 30 to 80, for example, 40 to 70, or even 45 to 65.

9. The peristaltic pump tube according to claim 1, wherein the base silicone material has a number average molecular weight of 200,000 g / mol to 1,000,000 g / mol.

10. The peristaltic pump tube according to claim 1, wherein the base silicone material has a weight-average molecular weight of 200,000 g / mol to 1,000,000 g / mol.

11. The peristaltic pump tube according to claim 1, wherein the accelerator comprises a polyalkylsiloxane.

12. The peristaltic pump tube according to claim 11, wherein the polyalkylsiloxane comprises a vinyl-terminated polyalkylsiloxane, a trimethyl-terminated polyalkylsiloxane, a hydroxy-terminated polyalkylsiloxane, or a combination thereof.

13. The peristaltic pump tube according to claim 1, wherein the curing agent comprises a silicon hydride-containing polyalkylsiloxane.

14. The peristaltic pump tube according to claim 1, wherein the catalyst comprises a hydrosilylation reaction catalyst.

15. A peristaltic pump tube according to claim 1, having a compression hysteresis loss of less than 40% for 100,000 to 400,000 cycles at a frequency of 20 Hz and a 20% distortion range.

16. A peristaltic pump tube according to claim 1, having at least one of the following properties at room temperature, as measured by ASTM D1708: a) tensile strength of 5.5 MPa to 9.5 MPa, b) elongation of 350% to 600%, c) breaking energy greater than 2000 N·mm, or a combination thereof.

17. A peristaltic pump tube according to claim 1, having at least one of the following properties at 60°C as measured by ASTM D1708: a) tensile strength of 5.5 MPa to 9.5 MPa, b) elongation of 275% to 500%, c) breaking energy greater than 2000 N·mm, or a combination thereof.

18. A peristaltic pump tube according to claim 1, having at least one of the following characteristics at 60°C in a notched tensile test measured at a tensile speed of 50 mm / min: a) tensile strength of 15 MPa to 50 MPa, b) elongation at break of more than 400%, c) energy at break of at least 500 N·mm, d) nonlinear fracture at break, or a combination thereof.

19. A peristaltic pump tube according to claim 1, having a burst pressure greater than 4.75 bar, or greater than 4.8 bar, or even greater than 4.9 bar, as measured by ASTM D1599.

20. A peristaltic pump tube according to claim 1, having a compression set of 4.8% to 5.2%.

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