Colored polymer composition for use in medical technology applications

Abstract

The present invention provides a compounded and colored polyoxymethylene polymer composition formulated to meet various government and safety requirements necessary for use in medical and / or food contact applications. [Solution] A kneaded colored polymer composition, tested at 190°C under a load of 2.16 kg, yielding approximately 30 cm 3 A kneadable colored polymer composition is provided, comprising: a polyoxymethylene polymer having a melt volume flow rate of less than 10 minutes and present in the polymer composition in an amount of at least 70% by weight; and at least one colorant present in the polymer composition in an amount of less than about 15% by weight, wherein the one or more colorants are present in the polymer composition in an amount of less than about 15% by weight.

Description

[Technical Field]

[0001]

[0001] This application claims priority over U.S. Provisional Application No. 62 / 666,485, filed on 3 May 2018 (which is incorporated herein by definition in its entirety). [Background technology]

[0002]

[0002] Medical-grade instruments must meet high safety standards. In particular, the materials from which the instruments are manufactured must be approved for their intended use and must pass rigorous testing to identify any exudates or extracts that could harm the user of the instrument.

[0003]

[0003] Typically, such stringent standards limit the types of additives available for use in medical device materials such as polymers. For example, many polymer additives are not approved for use in medical device materials, or are approved only in very small amounts. There are specific problems when attempting to color polymer materials intended for the manufacture of medical devices. There remain challenges in formulating polymer compositions to have a desired color while remaining approved for use in medical applications.

[0004]

[0004] For example, certain problems have been encountered in attempts to manufacture compound colored polyoxymethylene polymers for use in medical device applications. For example, the polyoxymethylene polymer itself must meet various government regulations in order to be used in medical applications. Furthermore, polyoxymethylene polymers do not always readily accept or homogeneously mix many pigments and dyes. For example, many colorants can cause blooming in the polyoxymethylene polymer, resulting in polymer products with surface defects and / or aggregation. [Overview of the project] [Problems that the invention aims to solve]

[0005]

[0005] In view of the above, there is a need for mass-colored polymer compositions for use in medical technology applications. [Means for solving the problem]

[0006]

[0006] Generally, the present invention relates to polymer formulations that can be used in medical technology applications. More specifically, the present invention relates to a compound colored polyoxymethylene polymer composition that can be formulated to meet a number of government and safety requirements, enabling the use of the compound colored polymer composition for manufacturing medical products and / or molded articles for food contact. For example, in one embodiment, the compound colored polymer composition can be used to mold components for dry powder inhalers and / or insulin pens.

[0007]

[0007] For example, in one embodiment, the present invention relates to a kneaded colored polymer composition for medical or food container applications. This kneaded colored polymer composition was tested at 190°C under a load of 2.16 kg and yielded approximately 30 cm 3 The polymer comprises a polyoxymethylene polymer having a melt volume flow rate of less than 10 minutes. The polyoxymethylene polymer is present in the polymer composition in an amount of at least about 70% by weight, for example, at least about 80% by weight, for example, at least about 90% by weight, for example, at least about 93% by weight. The polyoxymethylene polymer is mixed with at least one colorant. For example, in one embodiment, the polyoxymethylene polymer is mixed with at least two colorants, for example, about 3 to about 1 It can be mixed with zero types of colorants. One or more colorants are present in the polymer composition in an amount sufficient to knead and color the composition. Generally, one or more colorants can be present in the polymer composition in an amount of less than about 15% by weight. According to the present invention, the polyoxymethylene polymer and at least one colorant are selected so that the entire polymer composition passes USP Class VI and ISO-10993 tests. The polymer composition can also be formulated to be latex-free and to be free of animal by-products. In one embodiment, the polymer composition can also be melamine-free.

[0008]

[0008] In one embodiment, the polyoxymethylene polymer is used in accordance with 21 CFR §177.2470-2480, and the extract is prepared in accordance with 21 CFR §1.75.300(d) to 0.5 mg / inch 2 The polymer composition is selected to contain less than 0.5 mg / inch of net chloroform-soluble extract. Furthermore, when the composition is tested with chloroform according to 21 CFR §177.2470-177.2480, it is selected to contain less than 0.5 mg / inch. 2 The composition can be formulated to produce less than 10 μg / cm³ of extractable formaldehyde. For example, this composition may be formulated to produce about 10 μg / cm³. 2 Less than, for example, about 8 μg / cm³ 2 Less than, for example, about 6 μg / cm³ 2 Less than, for example, about 5 μg / cm³ 2 Less than, for example, approximately 2 μg / cm³ 2 It may contain less than 1% formaldehyde extract. This polymer composition can also be formulated to pass the European Regulation EC-10 / 2011 test.

[0009]

[0009] The one or more colorants present in the polymer composition may include a yellow colorant, a blue colorant, a red colorant, a green colorant, a white colorant, a black colorant, or a mixture thereof. Each colorant present in the blended colored polymer composition may include less than 20 ppm of acid-soluble antimony, less than 30 ppm of arsenic, less than 50 ppm of lead, less than 10 ppm of cadmium, less than 10 ppm of cobalt, less than 10 ppm of copper, less than 50 ppm of nickel, less than 1 ppm of selenium, less than 1 ppm of mercury, and less than 100 ppm of zinc. The polymer composition may be in the form of blended pellets.

[0010]

[0010] Polyoxymethylene polymer and one or more colorants, in addition to various other additives Additives and components can be present in the polymer composition. For example, the polymer composition may contain an acid scavenger such as tricalcium citrate. The polymer composition may also contain an antioxidant. In one embodiment, the antioxidant is ethylenebis(oxyethylene)bis-(3-(5-tert-butyl-4-hydroxy-m-tolyl)-propionate). In yet another embodiment, the polymer composition contains a nucleating agent which may be a terpolymer.

[0011]

[0011] In one particular embodiment, the kneaded colored polymer composition is also a Laser marking may be possible. For example, a laser marking additive can be included in the polymer composition. In one embodiment, the laser marking additive includes encapsulated antimony trioxide.

[0012]

[0012] Other features and aspects of the present invention will be discussed in more detail below.

[0013] The full and implementable disclosure of the present invention is provided in the remainder of this specification, including reference to the accompanying drawings. This will be explained in more detail in the section below. [Brief explanation of the drawing]

[0013] [Figure 1] Figure 1 shows a medical device comprising a polymer prepared as disclosed herein. [Figure 2] Figure 2 shows a medical device comprising a polymer prepared as disclosed herein. [Figure 3] Figure 3 shows a medical device comprising a polymer prepared as disclosed herein. [Figure 4] Figure 4 shows a plurality of medical devices comprising a polymer prepared as disclosed herein.

Mode for Carrying Out the Invention

[0014]

[0014] The repeated use of reference numerals in this specification and the drawings is intended to represent the same or similar features or components of the present invention. It is understood by those skilled in the art that this discussion is only an explanation of representative embodiments and is not intended to limit the broader aspects of the present invention.

[0015] This discussion is only an explanation of representative embodiments and is not intended by those skilled in the art to limit the broader aspects of the present invention. It is understood by those skilled in the art that this discussion is only an explanation of representative embodiments and is not intended to limit the broader aspects of the present invention.

[0015]

[0016] Generally, the present invention relates to a filled and colored polyoxymethylene (POM) polymer composition for use in medical technology applications. Particularly advantageously, some embodiments of the polymer compositions disclosed herein can reduce the regulatory burden in manufacturing products approved for biocompatibility and / or food contact. For example, polymer articles manufactured as in the present invention can, in some embodiments, be certified as safe for biocompatibility and / or food contact in the form of raw materials, and subsequently such certification can be given to the finished products manufactured therefrom. In some embodiments, the polymers manufactured as in the present invention are USP

[0016]

[0017] In some embodiments, the polymers manufactured as in the present invention are USP Class VI testing can satisfy FDA food contact standards such as ISO-10993, Chapter 21 of the Code of Federal Regulations (CFR), EU food contact standards such as Regulation (EC) No. 1935 / 2004, 2023 / 2006, 10 / 2011, Resolution AP(89)1, German BfR-IX, Spanish Royal Decree 847 / 2011, and Italian Decree 21 / 3 / 73.

[0017]

[0018] The following are some of the relevant issues concerning biocompatibility, food contact, and / or medical device applications. This is an overview of the standards. The following overview is not entirely complete and is intended only to provide representative standards achieved by the compliant materials.

[0018]

[0019] USP Class VI and ISO-10993 are biocompatibility standards (e.g., medical devices). This concerns materials. The United States Pharmacopeia is the organization that developed USP Class tests to help minimize public health concerns regarding materials (e.g., polymers). USP Class VI in particular is the most stringent of the USP standards and requires that materials be extracted in saline, alcoholic saline, polyethylene glycol, and vegetable oil under three different temperature profiles: first at 50°C for 72 hours, second at 70°C for 24 hours, and third at 121°C for 1 hour. The extracts are tested by injecting them into two test models (animal subjects); one model is injected intravenously or intraperitoneally, and the other model is injected intradermally. The models are observed after a series of time intervals (e.g., 24, 48, and / or 72 hours) to evaluate both internal (e.g., disease, death) and / or external (e.g., rash, reaction) toxic effects. Pieces of the material are implanted into the muscle tissue of the model and the reaction is evaluated after a longer period (e.g., 5-7 days).

[0019]

[0020] ISO-10993 is a broader and more comprehensive standard than USP Class IV. Yes. The FDA has evaluated cytotoxicity (e.g., at 37°C for 24 - 73 hours), sensitization (e.g., by guinea pig maximization and local lymph node assay according to ASTM - F2148), irritation / dermal reactivity, acute systemic toxicity, material - mediated pyrogenicity (e.g., according to USP - 34 <151>), subacute or subchronic toxicity, genotoxicity (e.g., bacterial gene mutation assay according to OECD471 (1997), mouse lymphoma gene mutation assay according to OECD476 (1997), chromosome aberration assay according to OECD473 (2014), micronucleus assay according to OECD487 (2014), bone marrow micronucleus assay according to OECD474 (2014), bone marrow chromosome aberration assay according to OECD475 (1997), and / or peripheral blood micronucleus assay according to OECD474), implantation effect, blood compatibility (e.g., hemolysis according to ASTM - F756 or equivalent, complement activation according to ELISA or ASTM - F1984 method, and thrombogenicity), chronic toxicity assay, carcinogenicity, reproductive or developmental toxicity, and degradation, etc. The main biocompatibility evaluation items for consideration. For limited contact (up to 24 - hour period), long - term contact (longer than 1 day up to 30 - day period), and permanent contact (longer than 30 - day period), any form can be investigated. The investigation should reflect the proposed end - use of the article / material. For example, the test requirements may vary among the use categories suggested by the FDA, such as surface devices that contact intact skin, mucosa, or damaged or injured surfaces; external connecting devices that indirectly contact the blood pathway, tissue, tissue fluid, subcutaneous space, bone, dentin, or circulating blood; and implant devices that contact tissue, tissue fluid, subcutaneous space, bone, or blood.

[0020]

[0021] Title 21 of the CFR generally deals with foods and drugs. In particular, 21 CFR §177. 2470 and §177.2480 target POM copolymers and homopolymers respectively. Compatible auxiliaries such as stabilizers or pigments can be added. POM polymers are at 0.5 mg / inch 2It is not possible to produce a net chloroform-soluble extract with a larger food contact area, and its use is limited to temperatures below 250°F. The extract is prepared according to the simulated use scenarios shown in 21 CFR §175.300(d) and reproduced below.

[0021] [Table 1]

[0022] [Table 2]

[0023]

[0022] 21 CFR §177.2470 and §177.2480 refer to POM polymers. Further requirements are detailed below. When POM polymers are ground or cut into particles that pass through US Standard Sieve No. 6 and remain on US Standard Sieve No. 10, with or without additives, the total extract shall not exceed (i) 0.2% by weight after extraction in distilled water at reflux temperature for 6 hours, or (ii) 0.15% by weight after extraction in n-heptane at reflux temperature for 6 hours. POM homopolymers shall not produce more than 0.005% by weight of formaldehyde. Furthermore, POM homopolymers must contain no more than 1.9% by weight of stabilizers. The minimum number-average molecular weight of the copolymer is 25,000, and the density is 1.39-1.44 g / cm³. 3 During this period, the melting point is between 172 and 184°C. Approved POM copolymers may be reaction products of trioxane with ethylene oxide or 5% by weight or less of butanediol formal. The minimum number average molecular weight of the copolymer is 15,000. Approved copolymers must contain multiple stabilizers in an amount of 2.0% by weight or less, and the amount of any single stabilizer is not greater than 1.0% by weight.

[0024]

[0023] Generally, polyoxymethylene polymer composition and polyoxymethylene polymer The substance itself is relatively resistant to formaldehyde release. For example, 10 μg / cm³ 2 Less than approximately 8 μg / cm³ 2 Less than, for example, about 6 μg / cm³ 2 Less than, for example, about 5 μg / cm³ 2 Less than, for example, about 3 μg / cm³ 2 Less than, for example, approximately 2 μg / cm³ 2 Less than a certain amount of extractable hormone A polymer composition can be formulated to produce formaldehyde. The composition can also be configured to release less than about 6 mg / kg of formaldehyde, for example less than about 5 mg / kg, for example less than about 4 mg / kg, for example less than about 3 mg / kg, for example even less than about 2 mg / kg, when tested according to Test VDA-275 after 24 hours using a plaque having a width of 2 mm.

[0025]

[0024] European regulations concerning polymer food contact standards are EC10 / 2011. It can be seen that, similar to 21 CFR, this rule enumerates a number of simulated scenarios and materials to give test conditions that mimic realistic worst-case scenarios of the proposed use of the material, for example, Tables 1 and 2 of Annex V detail the contact times and temperatures for test scenarios using the simulated extractants listed in Table 1 of Annex III.

[0026]

[0025] EC10 / 2011 also specifies the amount of various metals per unit mass of food or food imitation. The total migration limits for the following are listed: barium - 1 ppm; cobalt - 0.05 ppm; copper - 5 ppm; iron - 48 ppm; lithium - 0.6 ppm; manganese - 0.6 ppm; and zinc - 25 ppm. Primary aromatic amines not listed in Table 1 of Annex I shall not be released in detectable amounts (less than 0.01 ppm).

[0027]

[0026] Various EU publications have further restrictions on additives such as colorants (coloring additives). For example, EC10 / 2011 limits the amount of carbon black to 2.5% by weight or less, benzo(a)pyrene to 0.25 ppm or less, and toluene extractable fraction to 0.1% by weight or less.

[0028]

[0027] For example, AP(89)1 contains metals and metalloids in the coloring agent, and antimony - It is specified that the following may be soluble in 0.1M HCl in amounts of 0.05 wt%; arsenic - 0.01 wt%; barium - 0.01 wt%; cadmium - 0.01 wt%; chromium - 0.1 wt%; lead - 0.01 wt%; mercury - 0.005 wt%; and selenium - 0.01 wt% or less. Primary aromatic amines in colorants that are soluble in 1M HCl and expressed as aniline must be present in amounts less than 500 ppm. In particular, carbon black must not contain more than 0.15 wt% of the toluene extractable fraction. Extractable polychlorinated biphenyls must not exceed 25 ppm.

[0029]

[0028] German BfR-IX specifies the same metal purity limits as AP(89)1, and further, The requirement is that the coloring agent must withstand a temperature range of approximately 150°C to 300°C while the plastic is being processed.

[0030]

[0029] Spanish Royal Decree 847 / 2011 specifies 0.1N-HCl, except that This specifies the same metal purity limitations as AP(89)1.

[0030] Italian Decree 21 / 3 / 73 specifies 0.1N-HCl, and further specifies arsenic as 0. Except for the restriction to 0.005% by weight or less, the same metal purity restrictions as AP(89)1 are specified.

[0031]

[0031] In some embodiments, the polymer composition is processed with processing parameters and combination By carefully selecting the components of the product, it is formulated to satisfy at least one of the above approvals. For example, the preparation of polyoxymethylene polymers and the selection of additives (e.g., coloring additives and / or laser marking additives) can be independently operated to produce a final product (e.g., material, instrument part, or finished instrument) that complies with at least one of the above criteria.

[0032]

[0032] The preparation of polyoxymethylene polymers involves the presence of molecular weight modifiers such as glycols. This can be done by polymerizing a polyoxymethylene-forming monomer such as trioxane or a mixture of trioxane and a cyclic acetal such as dioxolane. The polyoxymethylene polymer used in the polymer composition may include homopolymers or copolymers. According to one embodiment, the polyoxymethylene is a homo- or copolymer containing at least 50 mol%, for example, at least 75 mol%, for example, at least 90 mol%, for example, even more than 97 mol%, of -CH2O- repeating units.

[0033]

[0033] In one embodiment, a polyoxymethylene copolymer is used. - may contain repeating units in about 0.01 mol% to about 20 mol%, and particularly about 0.5 mol% to about 10 mol%, comprising a saturated or ethylenically unsaturated alkylene group or cycloalkylene group having at least two carbon atoms, having a sulfur atom or oxygen atom in the chain and possibly containing one or more substituents selected from the group consisting of alkylcycloalkyl, aryl, aralkyl, heteroaryl, halogen, or alkoxy. In one embodiment, a cyclic ether or acetal that can be introduced into the copolymer by a ring-opening reaction is used.

[0034]

[0034] Preferred cyclic ethers or acetals are of the following formula:

[0035] [ka]

[0036] (In the formula, x is 0 or 1, R 2 (In appropriate cases, this is a C1-C4 alkyl group or a C1-C4 alkoxy group, and / or a C2-C4 alkylene group having one or more substituents, preferably a halogen atom, preferably a chlorine atom.) These are examples of cyclic ethers such as ethylene oxide, propylene 1,2-oxide, butylene 1,2-oxide, butylene 1,3-oxide, 1,3-dioxane, 1,3-dioxolane, and 1,3-dioxepane, and linear oligos or polyformals such as polydioxolane or polydioxepane as comonomers. It is particularly advantageous to use copolymers consisting of 99.5 to 95 mol% trioxane and 0.01 to 5 mol%, for example 0.5 to 4 mol%, of one of the above comonomers. In one embodiment, the polyoxymethylene polymer contains a relatively small amount of comonomer. For example, the comonomer may be present in an amount of less than about 2 mol%, for example less than about 1.5 mol%, for example less than about 1 mol%, for example less than about 0.8 mol%, for example less than about 0.6 mol%.

[0037]

[0035] In one embodiment, the preparation of polyoxymethylene is carried out using a molecular weight modifier. Polymerization can be carried out by polymerizing a polyoxymethylene-forming monomer, such as trioxane or a mixture of trioxane and dioxolane, in the presence of ethylene glycol or methylal. Polymerization can be carried out as precipitation polymerization or in a molten state. Initiators that can be used are compounds known on their own, such as trifluoromethanesulfonic acid, which are preferably added to the monomer as a solution in ethylene glycol. The catalyst may be liquid, solid, or gaseous. In one embodiment, the catalyst may contain a boron compound such as boron trifluoride. Boron trifluoride can be present during gaseous treatment. The polymerization and post-treatment procedures and termination of the obtained product can be carried out according to methods known on their own. The molecular weight of the obtained polymer, and therefore the MVR value, can be adjusted by a suitable selection of polymerization parameters, such as the duration of polymerization or the amount of molecular weight modifier.

[0038]

[0036] The melting point of polyoxymethylene polymer (or a blend of multiple polymers) is The melting point can vary depending on how the polymer is manufactured, its molecular weight, and various other factors. For example, in one embodiment, the melting point may be about 150°C to about 200°C. The weight-average molecular weight of the polymer can vary from about 5,000 to about 200,000, for example, from about 7,000 to about 150,000.

[0039]

[0037] In one embodiment, polyoxymethyl used in the polymer composition The polymer may contain a relatively large amount of reactive or functional groups at its terminal positions. The reactive groups may include, for example, -OH or -NH2 groups.

[0040]

[0038] In one embodiment, the polyoxymethylene polymer is all on the polymer The end groups may have at least about 50% more terminal hydroxyl groups, such as hydroxyethylene groups and / or hydroxyl side groups. For example, a polyoxymethylene polymer may have at least about 70%, for example at least about 80%, or for example at least about 85%, of its end groups, based on the total number of end groups present, which may be hydroxyl groups. It should be understood that the total number of end groups present includes all side chain end groups.

[0041]

[0039] In one embodiment, the polyoxymethylene polymer is at least 15 mm The polyoxymethylene polymer has a terminal hydroxyl group content of moles / kg, for example, at least 18 mmol / kg, or for example, at least 20 mmol / kg. In one embodiment, the terminal hydroxyl group content is in the range of 18 to 50 mmol / kg. In another embodiment, the polyoxymethylene polymer may contain terminal hydroxyl groups in amounts less than 20 mmol / kg, for example, less than 18 mmol / kg, or for example, less than 15 mmol / kg. For example, the polyoxymethylene polymer may contain terminal hydroxyl groups in amounts of about 5 mmol / kg to about 20 mmol / kg, for example, about 5 mmol / kg to about 15 mmol / kg. For example, a polyoxymethylene polymer having a lower terminal hydroxyl group content but a higher melt volume flow rate can be used.

[0042]

[0040] In addition to, or instead of, terminal hydroxyl groups, polyoxymethylene polymer These polymers may also have other typical end groups. Examples of these include alkoxy groups, formate groups, acetate groups, or aldehyde groups. According to one embodiment, the polyoxymethylene is a homo- or copolymer containing at least 50 mol%, for example, at least 75 mol%, for example, at least 90 mol%, for example, even more than 95 mol%, of -CH2O- repeating units.

[0043]

[0041] In one embodiment, the polyoxymethylene polymer is subjected to a cationic polymerization process. It can be manufactured using a solvent, followed by solution hydrolysis to remove unstable end groups. During cationic polymerization, glycols such as ethylene glycol or methylal can be used as chain termination agents. Heteropoly acids, trifric acid, or boron compounds can be used as catalysts.

[0044]

[0042] The polyoxymethylene polymer may have any preferred molecular weight. The molecular weight of Mer may be, for example, about 4,000 g / mol to about 20,000 g / mol. However, in other embodiments, the molecular weight may be well higher than 20,000 g / mol, for example, about 20,000 g / mol to about 100,000 g / mol.

[0045]

[0043] Polyoxymethylene polymers present in the composition are generally ISO-113 According to step 3, the result was approximately 0.1 to 80 cm at 190°C and 2.16 kg. 3 It may have a melt flow index (MFI) in the range of / 10 minutes. In one embodiment Polyoxymethylene polymer is approximately 30 cm 3 / Less than 10 minutes, for example, about 25cm 3 / Less than 10 minutes, for example, about 20cm 3 / Less than 10 minutes, for example, about 15cm 3 / Less than 10 minutes, for example, about 10cm 3 / Less than 10 minutes, for example, about 5cm 3 It may have a melt flow index of less than 10 minutes. The melt flow index is generally about 0.5 cm 3 Higher than / 10 minutes. In another embodiment, a polyoxymethylene polymer having a relatively high melt flow index can be used. For example, a polyoxymethylene polymer with a melt flow index of about 25 cm 3 / 10 minutes ~ approx. 70cm 3 / 10 minutes, for example, about 30cm 3 / 10 minutes ~ approximately 55cm 3 It may have a melt flow index of / 10 minutes.

[0046]

[0044] Suitable commercially available polyoxymethylene polymers are provided by Celanese. It is available under the product name Hostaform (registered trademark) (HF).

[0045] The polyoxymethylene polymer is at least 50% by weight, for example, at least 6 The polyoxymethylene polymer can be present in the polyoxymethylene polymer composition in amounts of 0% by weight, for example, at least 70% by weight, for example, at least 80% by weight, for example, at least 85% by weight, for example, at least 90% by weight, for example, at least 93% by weight, for example, at least 95% by weight. Generally, the polyoxymethylene polymer is present in amounts of less than about 100% by weight, for example, less than about 99% by weight, for example, less than about 97% by weight, where weight is based on the total weight of the polyoxymethylene polymer composition.

[0047]

[0046] The reinforcing fibers that can be included in the composition are mineral fibers such as glass fibers, These include polymer fibers, particularly organic high modulus fibers such as aramid fibers, metallic fibers such as steel fibers, carbon fibers, natural fibers, and / or fibers from renewable resources. Reinforcing fibers can be present in the molded composition in an amount ranging from 5 to 45% by weight, for example, 10 to 40% by weight, where weight is relative to the total weight of the composition. These fibers may be modified or unmodified, and may be sized to improve adhesion to the polymer, or chemically treated. For example, glass fibers can be used. Reinforcing fibers can be compounded into a polyoxymethylene matrix, for example, in an extruder or kneader. However, the reinforcing fibers may also take the form of continuous filament fibers coated or impregnated with the polyoxymethylene molded composition in a process advantageous for this purpose, and then processed or wound into continuous strands, or cut to a desired pellet length such that the fiber length and pellet length are the same. An example of a particularly favorable process for this purpose is the pultrusion process.

[0048]

[0047] The polymer composition further contains an impact resistance modifier such as a thermoplastic elastomer Thermoplastic elastomers are materials that possess both thermoplastic and elastomer properties. Examples of thermoplastic elastomers include styrene block copolymers, polyolefin blends called thermoplastic olefin elastomers, elastomer alloys, thermoplastic polyurethanes, thermoplastic copolyesters, and thermoplastic polyamides.

[0049]

[0048] Examples of thermoplastic elastomers include polyester elastomer (TPE-E), Examples include thermoplastic polyamide elastomers (TPE-A) and, in particular, thermoplastic polyurethane elastomers (TPE-U).

[0050]

[0049] The amount of thermoplastic elastomer contained in the polymer composition is determined by various factors The amount can vary depending on the circumstances. For example, the thermoplastic elastomer can be present in an amount ranging from about 0.5% by weight to about 50% by weight. For example, in one embodiment, the thermoplastic elastomer or impact modifier can be present in the composition in an amount of less than about 25% by weight, for example less than about 15% by weight, for example less than about 10% by weight. Generally, the thermoplastic elastomer or impact modifier can be present in an amount greater than about 2% by weight, for example greater than about 5% by weight, e.g. For example, it exists in amounts greater than approximately 8% by weight, or more than approximately 10% by weight.

[0051]

[0050] In one embodiment, an impact modifier or thermoplastic elastomer is present in the composition. If present, the composition may also contain a coupling agent. The coupling agent can generally be present in an amount of about 0.1% to about 2% by weight, for example, about 0.1% to about 1% by weight.

[0052]

[0051] In one embodiment, the polymer composition is made to contain an acid scavenger. This is possible. The acid scavenger may contain a carboxylate salt. For example, the carboxylate salt may contain a fatty acid salt, such as a metal salt of a fatty acid. For example, the carboxylate salt may contain an alkaline earth metal salt of a fatty acid. The cation of the salt may contain, for example, calcium, barium, lithium, sodium, magnesium, zinc, etc.

[0053]

[0052] Fatty acids may generally contain carbon chains of about 3 to 20 carbon atoms. The fatty acid may contain dicarboxylic acid or tricarboxylic acid.

[0053] In one embodiment, the metal salt of the fatty acid is citric acid, propionic acid, stearic acid The composition may include metal salts of phosphoric acid, butanoic acid, hexanoic acid, decanoic acid, lauric acid, myristic acid, palmitic acid, etc. In one particular embodiment, the metal salt of the fatty acid may include calcium propionate, calcium citrate such as 12-hydroxystearate, tricalcium citrate, and mixtures thereof. In one embodiment, if the polyoxymethylene polymer composition contains one or more colorants, various benefits and advantages can be obtained by combining the colorants with calcium propionate.

[0054]

[0054] One or more carboxylates are generally added in an amount greater than about 0.05% by weight, for example The polymer composition contains more than approximately 0.1% by weight, for example, more than approximately 0.2% by weight, for example, more than approximately 0.3% by weight, for example, more than approximately 0.4% by weight, for example, more than approximately 0.5% by weight. One or more carboxylates are generally present in the polymer composition in an amount of less than approximately 5% by weight, for example, less than approximately 3% by weight, for example, less than approximately 2% by weight, for example, less than approximately 1.5% by weight, for example, less than approximately 1% by weight.

[0055]

[0055] The polymer composition of the present invention may also contain, for example, antioxidants, UV stabilizers or heat stabilizers. Other known additives such as impact modifiers, impact resistance modifiers, and / or reinforcing fibers may also be included. Furthermore, the composition may include processing aids, such as adhesion promoters, lubricants, nucleating agents, mold release agents, fillers, or antistatic agents, as well as additives that impart desired properties to the composition and the articles or parts produced therefrom.

[0056]

[0056] In one embodiment, an ultraviolet light stabilizer can be present. The agent may contain benzophenone, benzotriazole, or benzoate. If present, the UV light absorber may be present in the polymer composition in an amount of at least about 0.01% by weight, for example at least about 0.05% by weight, for example at least about 0.075% by weight, and less than about 1% by weight, for example less than about 0.75% by weight, for example less than about 0.5% by weight, where weight is based on the total weight of each polymer composition.

[0057]

[0057] In one embodiment, a nucleating agent can be present. The nucleating agent has a degree of crystallinity. The amount can be increased and an oxymethylene terpolymer can be included. For example, in one particular embodiment, the nucleating agent can contain a terpolymer of butanediol diglycidyl ether, ethylene oxide, and trioxane. The nucleating agent is present in at least about 0.01% by weight, for example at least about 0.05% by weight, for example at least about 0.1% by weight, and less than about 2% by weight, for example less than about 1.5% by weight, for example less than about 1% by weight. It can be present in the composition in terms of quantity, where weight is based on the total weight of each polymer composition.

[0058]

[0058] In one embodiment, an antioxidant such as a sterically hindered phenol is present. This is possible. Commercially available examples include pentaerythrityltetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate], triethylene glycol bis[3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionate], 3,3'-bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionohydrazide], and hexamethylene glycol bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]. In one embodiment, the antioxidant introduced into the composition is ethylenebis(oxyethylene)bis-(3-(5-tert-butyl-4-hydroxy-m-tolyl)-propionate). The antioxidant may be present in the polymer composition in an amount of at least about 0.01% by weight, for example at least about 0.05% by weight, for example at least about 0.075% by weight, and less than about 1% by weight, for example less than about 0.75% by weight, for example less than about 0.5% by weight, where weight is based on the total weight of each polymer composition.

[0059]

[0059] In one embodiment, in addition to the ultraviolet light stabilizer, a photostatic amine such as a sterically hindered amine is used. A stabilizer can be present. Examples of hindered amine light stabilizers that can be used include N-methylated oligomeric hindered amine compounds. For example, the hindered amine light stabilizer can contain a high molecular weight hindered amine stabilizer. Other embodiments of the light stabilizer include 2,2,6,6-tetramethyl-4-piperidyl compounds, such as bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate or a polymer of dimethyl succinate and 1-(2-hydroxyethyl)-4-hydroxy-2,2,6,6-tetramethyl-4-piperidine. In one embodiment, the light stabilizer can contain 2-(2H-benzotriazol-2-yl)-4,6-bis(1-ethyl-1-phenylethyl)phenol. If present, the light stabilizer may be present in the polymer composition in an amount of at least about 0.01% by weight, for example at least about 0.05% by weight, for example at least about 0.075% by weight, and less than about 1% by weight, for example less than about 0.75% by weight, for example less than about 0.5% by weight, where weight is based on the total weight of each polymer composition.

[0060]

[0060] In one embodiment, a lubricant may be present. The lubricant may be a polymer A wax composition may be included. Furthermore, in one embodiment, a polyethylene glycol polymer (processing aid) may be present in the composition. The polyethylene glycol may have a molecular weight of, for example, about 1000 to about 5000, or for example, about 3000 to about 4000. For example, in one embodiment, PEG-75 may be present. In another embodiment, a fatty acid amide such as ethylenebis(stearamide) may be present. The lubricant may generally be present in the polymer composition in an amount of at least about 0.01% by weight, for example, at least about 0.05% by weight, or for example, at least about 0.075% by weight, and less than about 1% by weight, for example, less than about 0.75% by weight, or for example, less than about 0.5% by weight, where weight is based on the total weight of each polymer composition.

[0061]

[0061] In one embodiment, the polyoxymethylene polymer composition also contains form Aldehyde scavengers may be included. In one embodiment, the formaldehyde scavenger does not need to contain melamine. For example, in one embodiment, the formaldehyde scavenger may contain dicyandiamide alone or in combination with a copolyamide. If present, the acid scavenger is present in an amount of less than about 1% by weight, for example less than about 0.5% by weight, for example less than about 0.3% by weight, for example less than about 0.1% by weight, for example less than about 0.05% by weight, generally about 0.0001 It can be included in the polymer composition in an amount greater than weight percent.

[0062]

[0062] Furthermore, the polymer prepared according to the present invention is laser markable. It can be obtained and / or mass-colored. Furthermore, some embodiments do not need to contain latex and / or animal by-products.

[0063]

[0063] Generally, laser marking polymers are used to create images (for example, Laser marking is a method of forming a mark (such as a line, emoji, diagram, barcode), an imprint (for example, for visual and / or structural purposes), or other mark. In particular, the laser marking process often offers speed and precision, especially when compared to traditional printing processes.

[0064]

[0064] One particular advantage is that laser marking can be applied to the surface of the polymer by a second material ( The application of, for example, inks, is avoided, minimizing the number of substances that must be approved according to various biocompatibility and food contact regulations, such as those discussed herein. Depending on the parameters of the laser marking process (e.g., laser focal speed, temperature, wavelength, etc.), the laser mark is formed in some embodiments by foaming, engraving, color change, and / or carbonization. In addition to color change, the laser marking parameters can be configured to produce a mark having grayscale shading in the range between white and black (including both ends). The penetration of the marking process can be characterized by the staining depth; for example, in some embodiments, a staining depth greater than about 50 μm, and for example greater than about 100 μm, is desirable. In general, the staining depth is preferably less than the thickness of the polymer substrate so as to avoid impairing the mechanical properties of the substrate.

[0065]

[0065] For example, the laser marking process changes the color of the engraved area or The process can be configured to mark without altering the material (i.e., to remove the material). In some cases, the marked area can also be carbonized to create a dark, clearly defined contrast between the marked area and the surrounding polymer. In other examples, the marking process can be configured to foam certain areas to create a distinct texture between the marked and unmarked areas, with or without giving a color change on the marked area. Generally, foamed areas are produced when the polymer, melted by the laser, generates bubbles that remain trapped in the cooled molten material. Foaming can occur, for example, at low laser intensity. In some cases, the foamed areas exhibit a lighter color than the surrounding non-foamed areas, providing visual contrast in addition to texture. Some embodiments can be configured to minimize the foam height.

[0066]

[0066] The apparatus used for the laser marking process includes writing, masking, and Dot matrix lasers are widely available according to their operating modes and other configurations. For example, a writing laser can use at least one or more controllable mirrors to direct the laser beam towards the surface of a polymer substrate, writing to the surface according to a pre-programmed pattern or otherwise marking it. A mask laser marking process projects a laser beam onto a masking device that allows only the passage of portions of the beam that conform to a specific pattern cut into the mask, directing the portions passing through the mask towards the surface of the target polymer substrate. A dot matrix laser system uses a shutter device to construct markings from closely grouped but individual dot marks.

[0067]

[0067] An example of a traditional laser marking system is a CW or pulsed CO2 laser. and yttrium aluminum garnet (YAG) (e.g., Nd:YAG) lasers, where marking is achieved by the heat of the applied laser beam. The wavelength of the pulses generated by the system is within the visible or infrared spectrum. The pattern or marking to be made is formed by using a mask through which the laser beam passes, or by a focused laser beam that is moved or scanned to produce the desired marking or pattern. Such lasers are also used for marking, soldering, and welding, and in the case of marking, they melt, ablate, or vaporize the surface layer of the material to produce an identifiable marking or pattern. Alternatively, this type of article marking can be achieved by using a chemical reaction on the surface of the article to be marked, in which case a certain coating agent on the surface of the article is visually transparent but can cause a visible contrast change under the influence of the laser beam or laser pulse.

[0068]

[0068] CO2 lasers are primarily used to mark plastic surfaces such as packages. CO2 lasers have been used to create markings. A laser beam from a laser is guided through a copper stencil to form an imprint on a plastic surface. However, due to the shrinkage of some packages over the years, high-quality markings with good visibility are no longer satisfactory for this particular application, and CO2 lasers are often no longer suitable. Nevertheless, low-cost CO2 systems with lower marking quality using low-cost XY galvanometer equipment are still used for applications where high-quality marking is not required.

[0069]

[0069] YAG lasers are used for packaging marking and many other marking applications. Widely used. YAG lasers have shorter operating wavelengths and can mark on harder surfaces such as ceramic materials. In a YAG marking system, the beam is steered or scanned in one, two, or three dimensions by a pair of displaceable mirrors mounted to displace the laser beam perpendicularly to form a two-dimensional scan of the beam on the surface to be marked, such as in an XY galvanometer or XX galvanometer operated under computer control. The markings are engraved on the surface of articles with fine resolution and clarity of marking on relatively small surfaces, such as in the case of smaller packages.

[0070]

[0070] However, some polymers are lasers of a desired wavelength (e.g., UV to infrared). - It does not absorb energy and does not produce the desired marking result. Therefore, in some embodiments, laser marking additives can be used to enhance or otherwise enable marking of plastics in the IR, visible, and UV wavelength ranges. For example, with respect to laser-markable materials, the introduction of laser marking additives can improve contrast or other marking properties.

[0071]

[0071] It is deemed to satisfy all requirements for introduction into the polymer described herein. Examples of laser marking additives include, but are not limited to, Iriotec 8208. Iriotec 8208 is a representative example of a compound in which antimony trioxide is encapsulated within microspheres and supported within a polymer matrix (e.g., polyethylene). The mass ratio of the matrix to antimony trioxide can range from approximately 35:65 to approximately 25:75.

[0072]

[0072] In some embodiments, the laser marking additive is 0.1% by weight or more The additive can be introduced into the polymer in large quantities, for example, more than about 0.5% by weight, for example more than about 1% by weight, for example more than about 2% by weight. In some embodiments, the additive is present in an amount of less than about 4% by weight, for example less than about 3% by weight, for example less than about 2% by weight.

[0073]

[0073] Advantageously, such additives can be used in the processing of polymers as described herein. In some cases, no special processing parameters other than those used are required. In some cases, a temperature increase of 10°C to 20°C above the original temperature may be optimal. In some cases, the dispersion of additives can be improved by processing the polymer-additive mixture at a temperature higher than about 100°C, for example, higher than about 160°C. In some embodiments, the processing temperature is maintained at a temperature lower than about 300°C, for example, lower than about 280°C, for example, lower than about 250°C.

[0074]

[0074] The kneaded colored polymer is applied throughout the entire material, i.e., not merely as a colored surface coating. These are polymers that are more or less colored. In some embodiments, kneading coloring is achieved by mixing a pigment or other coloring additive into the polymer during processing. The colorant can be present in the composition in an amount of less than about 5% by weight, for example less than about 2.5% by weight, for example less than about 1% by weight, with at least about 0.01% by weight, for example at least about 0.1% by weight, for example at least about 0.5% by weight, for example at least about 0.8% by weight, for example at least about 1% by weight, where weight is based on the total weight of each polymer composition. In some examples, the colorant can be present in an amount of more than about 2% by weight, for example more than about 4% by weight, for example more than about 6% by weight, for example more than about 8% by weight, for example more than about 10% by weight. In various embodiments, the colorant can be present in an amount of less than about 15% by weight, for example less than about 13% by weight, for example less than about 11% by weight, for example less than about 9% by weight, for example less than about 7% by weight, for example less than about 5% by weight.

[0075]

[0075] For use in medical devices or objects authorized for food contact, the pigment and Both polymers must meet high safety standards. For example, as stated in Chapter US21 of the Code of Federal Regulations, the FDA requires a safety factor of 100 to be used when relying on animal testing to demonstrate safety for human use in the absence of other suggestive evidence. Typically, the FDA considers evidence regarding oral toxicity, primary irritation, sensitization, subacute cutaneous toxicity to intact and abraded skin, and carcinogenicity of topical pigment additives, although some tests may be omitted by demonstrating that such tests are not necessary to determine safety for the proposed use.

[0076]

[0076] It is deemed that all requirements for introduction into the polymer described herein are met. Examples of usable pigments include, but are not limited to, Sicotan Yellow K 2112, Kronos 2220, Kronos 2211, Kronos 2233, Printex FP, PV Fast Green GNX, PV Fast Yellow HG, Irgazin Yellow K 2070, Bayferrox 3910, Irgazin Red K 3840, Cromophtal Orange GP, Heliogen Blue K 7090, and Heliogen Green K 8730. The specifically disclosed pigments should be understood as merely representative examples of the various pigments that can be used.

[0077]

[0077] Sicotan Yellow K 2112 is a rutile pigment based on chromium(III) oxide, antimony pentoxide, and titanium dioxide. Acid-soluble antimony is present in amounts of less than approximately 20 ppm. Furthermore, unavoidable impurities are suppressed to less than 30 ppm arsenic, 50 ppm lead, less than 10 ppm cadmium, less than 10 ppm cobalt, less than 10 ppm copper, less than 50 ppm nickel, less than 1 ppm selenium, less than 1 ppm mercury, and less than 100 ppm zinc. Sicotan Yellow K 2112 complies with the following regulations and provisions: EU Regulation No. 1 This pigment complies with or is otherwise authorized to comply with Article 935 / 2004 / EC-3, AP(89)1, German BfR-IX, and Australian Regulation AS-2070-1999, and conditionally complies with the usage restrictions under EU (EC) Regulation 10 / 2011, French Decree 1227, Spanish Royal Decree 847 / 2011, Italian Decree 21 / 3 / 73, FDA 21CFR, Japan JHPA, and Chinese Regulation GB9685-2008. This pigment does not comply with Japan JHPA.

[0078]

[0078] Kronos 2211, 2220, and 2233 are representative examples of rutile pigments produced by the chloride process, representing R2 compounds corresponding to DIN-EN-ISO-591, Part 1, containing at least 95.5, 92.5, and 96 wt% TiO2, respectively, and are stabilized with aluminum, aluminum and silicon, and aluminum and silicon-containing compounds, respectively. The scattering forces of plastisol formulations containing the same may be about 10⁵, 99, and 10⁴, respectively. Various grades of titanium dioxide can be used depending on the needs of the target design. For example, Kronos 2233 resists degradation of the carrier polymer and high processing temperature Titanium dioxide maintains its coloring effect even at high temperatures.

[0079]

[0079] Printex FP is pigment black in accordance with 21 CFR §178.3297. This is a prime example of color 7 (color index #77266).

[0080] PV Fast Green GNX is a representative example of Pigment Green 7 (copper phthalocyanine), which is FDA compliant under 21 CFR §178.3297 without limitation.

[0080]

[0081] PV Fast Yellow HG is a representative example of Pigment Yellow 180 (benzimidazolone) that is FDA compliant under 21 CFR §176.170 for applications where the food-contact surface meets usage conditions B, C, D, E, F, and G from Table 2. This pigment is not described as compliant for applications meeting usage conditions A or H.

[0081]

[0082] Irgazin Yellow K 2070 is a representative example of Pigment Yellow 110 (isoindolinone) and complies with or is otherwise authorized to comply with the following regulations and provisions: EU Regulation No. 1935 / 2004 / EC-3, EU (EC) Regulation 10 / 2011, AP(89)1, German BfR-IX, Spanish Royal Decree 847 / 2011, Italian Decree 21 / 3 / 73, Australian Regulation AS2070-1999, and Chinese Regulation GB9685-2008, and is conditionally compliant with the restrictions on use under French Decree 1227, FDA 21CFR, and Japanese JHOSPA and JHPA.

[0082]

[0083] Bayferrox 3910 is Pigment Yellow 42 (Yellow Iron Oxide: FeO(OH)· This is a typical example of xH2O. Upon drying of the pigment, less than 3 ppm of arsenic, 1 ppm of cadmium, 10 ppm of lead, or 1 ppm of mercury is lost, and this pigment is subject to the following rules and regulations: EU-AP(89)1, German BfR-IX, French circular dated December 2, 1959 176, the Dutch Food Law / Packaging Regulations (Netherlands Warenwet / Regeling Verpakkingen); Implementing Regulations (Uitvoeringsvoorschriften) CIII-55, Spanish Resolution 4.1L1982 in accordance with Article 5 of Royal Decree 211 / 1992, Australian AS2070.6, USA 21CFR178.3297, and Japanese JHOSPA, or otherwise authorized.

[0083]

[0084] Irgazin Red K 3840 is a representative example of pigment red 254 (diketopyrrolopyrrole), and is subject to the following regulations and provisions: EU Regulation No. 1935 / 2004 / EC-3, E It complies with or is otherwise authorized in accordance with U(EC) Regulation 10 / 2011, AP(89)1, German BfR-IX, French Decree 1227, Spanish Royal Decree 847 / 2011, Italian Decree 21 / 3 / 73, and Australian Regulation AS2070-1999, and is conditionally compliant with the restrictions on use under FDA 21CFR, Japan JHOSPA and JHPA, and Chinese Regulation GB9685-2008.

[0084]

[0085] Cromophtal Orange GP is a representative example of Pigment Orange 64 (disazo condensation). It is compliant with the following regulations and provisions: EU Regulation No. 1935 / 2004 / EC-3, EU (EC) Regulation 10 / 2011, AP(89)1, German BfR-IX, French Decree 1227, Spanish Royal Decree 847 / 2011, Italian Decree 21 / 3 / 73, and Australian Regulation AS2070-1999, or otherwise authorized by FDA21C It is conditionally compliant with usage restrictions under FR, Japan JHOSPA, and China Regulation GB9685-2008.

[0085]

[0086] Heliogen Blue K 7090 is a pigment blue 15:3 or non-chlorinated copper phthalates. Anine (beta form with approximately 11% by weight of copper) is a representative example and is authorized in accordance with the following regulations and provisions: EU Regulation No. 1935 / 2004 / EC-3, AP(89)1, German BfR-IX, Japanese JHPA, and Australian Regulation AS2070-1999, or in other forms, and is conditionally compliant with the restrictions on use under EU (EC) Regulation 10 / 2011, French Decree 1227, Spanish Royal Decree 847 / 2011, Italian Decree 21 / 3 / 73, FDA 21CFR, Japanese JHOSPA, and Chinese Regulation GB9685-2008. Inevitable impurities are kept to less than 20 ppm antimony, less than 20 ppm arsenic, less than 20 ppm lead, less than 30 ppm cadmium, less than 50 ppm chromium, less than 20 ppm selenium, less than 20 ppm mercury, and less than 20 ppm zinc. Primary aromatic amines are also suppressed to less than 100 ppm.

[0086]

[0087] Heliogen Green K 8730 is a representative example of Pigment Green 7 or Chlorinated Copper Phthalocyanine (containing approximately 5.6% by weight of copper) and is authorized in accordance with the following regulations and provisions: AP(89)1, or otherwise authorized, and is conditionally compliant with the restrictions on use under EU Regulation No. 1935 / 2004 / EC-3, EU(EC) Regulation 10 / 2011, German BfR-IX, French Decree 1227, Spanish Royal Decree 847 / 2011, Italian Decree 21 / 3 / 73, FDA 21CFR, Japan JHOSPA, Japan JHPA, Australian Regulation AS2070-1999, and Chinese Regulation GB9685-2008. Inevitable impurities are kept below 20 ppm for antimony, 20 ppm for arsenic, 20 ppm for lead, 30 ppm for cadmium, 50 ppm for chromium, 20 ppm for selenium, 20 ppm for mercury, and 20 ppm for zinc. Primary aromatic amines are also kept below 100 ppm.

[0087]

[0088] The composition of the present invention is formulated using any known technique in the art. The compositions can be formed into polymer articles. For example, each composition can be vigorously mixed to form a substantially homogeneous blend. The blend can be melt-kneaded at a heating temperature such that is higher than the melting point of the polymer used in the polymer composition but lower than the decomposition temperature. Alternatively, each composition can be melted and mixed together in a conventional single-screw or twin-screw extruder. Preferably, the melt mixing is carried out at a temperature in the range of 100 to 280°C, for example 120 to 260°C, for example 140 to 240°C, or 180 to 220°C. After extrusion, the compositions can be formed into pellets. The pellets can be formed into polymer articles by techniques known in the art, such as injection molding, thermoforming, blow molding, and rotational molding.

[0088]

[0089] By manufacturing pellets, raw materials for the manufacture of medical devices, for example, can be provided. This can be achieved. In one embodiment, the pellets are certified according to at least one biocompatibility or food contact standard. In one embodiment, by paying close attention to the formulation and processing of the pellets, biocompatibility or food contact certification can be given from raw materials to the final product, thereby reducing the regulatory burden on the manufacturing process.

[0089]

[0090] The polymers described herein comply with current Good Manufacturing Practices (GMP). It can be manufactured in accordance with the standards. For example, as required by EU Regulation No. 2230 / 2006, GMP includes (1) a quality assurance system that ensures that manufactured articles comply with applicable rules, such as by selecting starting materials that conform to pre-established specifications that guarantee compliance of the articles; (2) a quality control system that monitors the application of GMP and promptly corrects any non-compliant with GMP; and (3) This includes a documentation system that catalogs specifications and manufacturing formulations related to compliance with standards for manufactured goods or related GMP guidelines, which are made available to the relevant authorities upon request.

[0090]

[0091] Typical embodiments include a variety of medical devices. For example, see Figure 1. An inhaler 10 is shown. The inhaler 10 includes a housing 12 attached to a mouthpiece 14. The housing 12 is operationally associated with a plunger 16 for receiving a canister containing a composition to be inhaled. The composition may include a spray or a powder. In use, the inhaler 10 administers a measured dose of a drug, such as an asthma medication, to a patient. The asthma medication can be suspended or dissolved in a propellant gas, or it can be contained in a powder. When the patient activates the inhaler to inhale the drug, a valve opens, allowing the drug to be expelled from the mouthpiece. According to the present invention, the housing 12, the mouthpiece 14, and the plunger 16 can all be manufactured from the polymer composition described above.

[0091]

[0092] Referring to Figure 2, another medical product that can be manufactured according to the present invention is Figure 2 shows a medical syringe 20. The medical syringe 20 includes a plunger 24 and a housing 22 that is operationally associated with it. The housing 22 can slide relative to the plunger 24. The medical syringe 20 may be spring-driven. The medical syringe is for injecting drugs into a patient, usually in the thigh or buttocks. The medical syringe may be needleless or may contain a needle. If it contains a needle, the tip of the needle is usually protected within the housing before injection. On the other hand, a needleless syringe may contain a cylinder of pressurized gas that extrudes the drug through the skin without using a needle. According to the present invention, the housing 22 and / or the plunger 24 can be manufactured from the polymer composition described above.

[0092]

[0093] Referring to Figure 3, another example shows a hip joint implant. The hip implant includes a hip prosthesis 30 having a stem 31 and an articular engagement member or head 32. The hip prosthesis 30 can be manufactured from a polymer material according to the present invention. As shown, the hip prosthesis 30 is inserted into a reamed cavity within a bone 33 such as a femur.

[0093]

[0094] The hip joint implant shown in Figure 3 can also be manufactured in accordance with the present invention. The procedure further includes an acetabular cup 34. The acetabular cup 34 includes an articular engagement member adapted to receive the head 32 of the hip prosthesis 30. To implant the hip prosthesis 30 and the acetabular cup 34, both articles can be bonded to the bone using bone cement 35.

[0094]

[0095] In addition to being used to manufacture hip joint implants, the present invention is poly The polymer composition can also be used to manufacture various other orthopedic devices. For example, this polymer composition is well-suited for manufacturing knee prostheses such as tibial plateaus.

[0095]

[0096] In one embodiment, the polymer composition is used by a physician or surgeon during surgery. It is used to manufacture trial sizers to help determine the correct size of a plant. In one embodiment, each trial sizer can be color-coded to indicate a specific size. Referring to Figure 4, for example, several orthopedic instruments 40 are shown. All of the several orthopedic instruments 40 can be manufactured from the polymer composition of the present invention. As shown, each orthopedic instrument 40 includes a stem 42 and a joint engaging member or head 44. The entire orthopedic instrument can be manufactured from the polymer composition of the present invention, or, instead, only the head or joint engaging member can be manufactured from the polymer of the present invention. It can be manufactured from a composition. In yet another embodiment, the polymer composition may include a coating used to manufacture an articulated engagement member.

[0096]

[0097] As shown in Figure 4, each orthopedic instrument 40 has different dimensions or sizes. They are available and, as described above, can be manufactured in different colors. During surgery, the bone site can be prepared for implant insertion. Next, the surgeon can use a plurality of orthopedic instruments 40, as shown in Figure 4, to determine the appropriate size of the prosthesis to be used for a particular patient. Once the appropriate size has been determined, the surgeon can select the orthopedic instrument to be inserted into the patient's body from the second plurality of instruments. The second plurality of orthopedic instruments can be manufactured from the same polymer composition or from different materials.

[0097]

[0098] The polymers produced according to the present invention are based on the following representative embodiments. This allows for a better understanding. [Examples]

[0098]

[0099] In accordance with the present invention, 95.28 parts of POM flakes; Iriotec 8208 in part 2.5; Part 1 of Titandioxid Kronos 2211; 0.5 parts of POM terpolymer; Irganox 245 FF (part 0.4) 0.2 parts EBS wax (vegetable-based); 0.1 parts tricalcium citrate; and 0.02 parts of dicyandiamide; A polyoxymethylene polymer was prepared by mixing the following.

[0099] [000100] Extractable formaldehyde test showed 4.2 μg / cm³ 2 This was obtained. [000101] POM Pulver 13034, 9682 copies; 318 copies of PB MT RM; Titandioxid Kronos 2233 (64 parts); PV Fast Green GNX (part 2.7) 1.6 parts Heliogen Blue K 7090; 1.6 parts of Heliogen Green K 8730; and 0.1 copies of Bayferrox 3910; A second example of polyoxymethylene polymer was prepared by mixing the following.

[0100] [000102] Extractable formaldehyde test showed 1.3 μg / cm³ 2 The above polymer composition is laser markable. [000103] These and other modifications and changes to the present invention can be implemented by those skilled in the art without departing from the spirit and scope of the invention as more detailed in the appended claims. Furthermore, it should be understood that multiple aspects of the various embodiments can be interchanged in whole or in part. Furthermore, those skilled in the art will understand that the foregoing is for illustrative purposes only and is not intended to limit the invention as further described in such appended claims. The claims of the original application of this application are reproduced below. [Aspect 1] A blended colored polymer composition for medical or food container applications, Tested at 190°C under a load of 2.16 kg for approximately 30 cm 3 Having a melt volume flow rate of less than 10 minutes, and present in the polymer composition in an amount of at least 70% by weight. Polyoxymethylene polymers present; A coloring agent, wherein at least one coloring agent is present in the polymer composition in an amount sufficient to knead and color the composition, and such one or more coloring agents are present in the polymer composition in an amount of less than about 15% by weight; Includes; The polyoxymethylene polymer and the at least one coloring agent are selected such that the polymer composition passes USP Class VI and ISO-10993 tests, and the polymer composition is latex-free and free of animal by-products, wherein the compounded colored polymer composition is characterized by this selection. [Aspect 2] The polyoxymethylene polymer is present in 0.5 mg / inch in accordance with 21 CFR §177.2470-2480. 2 The kneaded colored polymer composition according to Embodiment 1, comprising a net chloroform-soluble extract of less than 1 / 2000, wherein the extract is prepared in accordance with 21 CFR §1.75.300(d). [Aspect 3] The aforementioned kneaded colored polymer composition was tested using chloroform in accordance with 21 CFR §177.2470~§177.2480 and yielded 0.5 mg / inch 2A kneaded colored polymer composition according to any one of embodiments 1 and 2, which generates less than 100% extractable formaldehyde. [Aspect 4] A kneaded colored polymer composition according to any one of embodiments 1 to 3, wherein the composition passes the European Regulation EC10 / 2011 test. [Aspect 5] The kneaded colored polymer composition according to any one of embodiments 1 to 4, wherein the composition contains more than about 93% by weight of the polyoxymethylene polymer. [Aspect 6] A kneaded colored polymer composition according to any one of embodiments 1 to 5, further comprising an acid scavenger. [Aspect 7] The kneaded colored polymer composition according to embodiment 6, wherein the acid scavenger contains tricalcium citrate, and the tricalcium citrate is present in the polymer composition in an amount of about 0.01% to about 0.5% by weight. [Aspect 8] The kneaded colored polymer composition according to any one of embodiments 1 to 7, wherein the polymer composition further comprises an antioxidant, and the antioxidant comprises ethylenebis(oxyethylene)bis-(3-(5-tert-butyl-4-hydroxy-m-tolyl)-propionate. [Aspect 9] The kneaded colored polymer composition according to any one of embodiments 1 to 8, wherein the polymer composition further comprises a nucleating agent, and the nucleating agent comprises a terpolymer. [Aspect 10] The kneaded colored polymer composition according to any one of embodiments 1 to 9, wherein the polymer composition further comprises a laser marking additive. [Aspect 11] The kneaded colored polymer composition according to embodiment 10, wherein the laser marking additive contains encapsulated antimony trioxide. [Aspect 12] The kneaded colored polymer composition according to any one of embodiments 1 to 11, wherein the at least one coloring agent comprises a yellow coloring agent, a blue coloring agent, a red coloring agent, a green coloring agent, a white coloring agent, a black coloring agent, or a mixture thereof. [Aspect 13] A kneaded colored polymer composition according to any one of embodiments 1 to 12, wherein the at least one coloring agent contains less than 20 ppm of acid-soluble antimony, less than 30 ppm of arsenic, less than 50 ppm of lead, less than 10 ppm of cadmium, less than 10 ppm of cobalt, less than 10 ppm of copper, less than 50 ppm of nickel, less than 1 ppm of selenium, less than 1 ppm of mercury, and less than 100 ppm of zinc. [Aspect 14] The kneaded colored polymer composition according to any one of embodiments 1 to 13, wherein the composition is in the form of compounded pellets. [Aspect 15] The kneaded colored polymer composition according to any one of embodiments 1 to 14, wherein the composition comprises at least two colorants. [Aspect 16] The kneaded colored polymer composition according to any one of embodiments 1 to 15, wherein the composition comprises about 3 to about 10 types of colorants. [Aspect 17] The kneaded colored polymer composition according to embodiment 7, wherein the polymer composition further comprises an antioxidant, the antioxidant comprising ethylenebis(oxyethylene)bis-(3-(5-tert-butyl-4-hydroxy-m-tolyl)-propionate, the polymer composition further comprises a nucleating agent, the nucleating agent comprising a terpolymer, and the polymer composition further comprises dicyandiamide and ethylenebis(stearamide). [Aspect 18] The kneaded colored polymer composition according to embodiment 17, wherein the composition comprises at least two colorants, all of which contain less than 20 ppm of acid-soluble antimony, less than 30 ppm of arsenic, less than 50 ppm of lead, less than 10 ppm of cadmium, less than 10 ppm of cobalt, less than 10 ppm of copper, less than 50 ppm of nickel, less than 1 ppm of selenium, less than 1 ppm of mercury, and less than 100 ppm of zinc. [Aspect 19] A kneaded colored polymer composition according to any one of embodiments 1 to 18, further comprising reinforcing fibers, wherein the reinforcing fibers are present in an amount of about 5% to about 45% by weight, and the reinforcing fibers include glass fibers. [Aspect 20] A medical device comprising a molded article manufactured from a kneaded colored polymer composition according to any one of embodiments 1 to 19. [Aspect 21] The medical device according to embodiment 20, wherein the medical device includes an orthopedic instrument that includes a joint engaging member. [Aspect 22] The medical device according to embodiment 20, wherein the medical device includes an inhaler including a housing, and the molded article includes the housing. [Aspect 23] The medical device according to embodiment 20, wherein the medical device includes a medical syringe including a housing, and the molded product includes the housing of the medical syringe.

Claims

[Claim 1] A blended colored polymer composition for medical or food container applications, Tested at 190°C under a load of 2.16 kg, approximately 30 cm ３ / A polyoxymethylene polymer having a melt volume flow rate of less than 10 minutes and present in the polymer composition in an amount of at least 70% by weight; A coloring agent, wherein at least one coloring agent is present in the polymer composition in an amount sufficient to knead and color the composition, and such one or more coloring agents are present in the polymer composition in an amount of less than about 15% by weight; Including; The polyoxymethylene polymer and the at least one coloring agent are selected such that the polymer composition passes USP Class VI and ISO-10993 tests, and the polymer composition is latex-free and free of animal by-products, wherein the compounded colored polymer composition is characterized by this selection.

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