Recycled resin composition and disposable medical device manufactured from the same

Abstract

To meet a need in the industry for thermoplastic compositions comprising recycled resin compositions that are biocompatible, sterilization-stable and useful for medical device applications.SOLUTION: Compositions including recycled resin components, and medical devices and components made with such compositions are disclosed. The compositions and medical devices are characterized as being biocompatible and sterilization stable. In one or more embodiments, the compositions include a recycled resin component and may include one or more of an anti-oxidant component, slip additive component, anti-static component, impact modifier component, colorant component, acid scavenger component, X-ray fluorescence agent component, radio opaque filler component, surface modifier component, melt stabilizer component, clarifier component, processing aid component and reinforcing agent component. Methods of forming medical articles and components are also disclosed.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to recycled resin compositions, medical devices formed from recycled resin compositions, and methods for producing medical devices from recycled resin compositions. This application is a divisional application of Japanese Patent Application No. 2020-097940, which is a divisional application of Japanese Patent Application No. 2017-162776, which is a divisional application of Japanese Patent Application No. 2015-250399, which is a divisional application of Japanese Patent Application No. 2013-525988. [Background technology]

[0002] Plastics form key components of disposable medical devices, non-disposable medical devices, medical device packaging, as well as the majority of other non-medical device applications, including automotive and everyday consumer goods applications. These thermoplastics include polymers such as polypropylene, polyethylene, polystyrene, polyethylene terephthalate, and polycarbonate, among others. The increased use of plastics over the past few decades has led to increased impacts with regard to landfill capacity and the depletion of fossil fuel-based resources. The increased use of plastics or plastic materials has also led to increased levels of environmental pollution and an associated carbon footprint.

[0003] In light of the above, there is growing interest in utilizing recycled thermoplastic polymer materials obtained from various sources. The growing interest in utilizing recycled thermoplastic polymer materials is driven by a number of factors, including increased consumer awareness and concern for protecting the environment, environmentally preferable purchasing policies developed by customers, brand owners' recognition of the benefits of environmental stewardship in marketing, the emergence of new regulations and environmental policies designed to reduce carbon footprints, and a desire to reduce the increasing costs of storage and / or landfill space coupled with stricter regulations for disposal and incineration. The growing interest in utilizing recycled thermoplastic polymer materials is also driven by recyclers' improved ability to consistently produce high-quality recycled resins. These factors have already resulted in the extensive use of recycled plastics in automotive and food packaging applications. For example, Ford Motor Company is developing ways to increase the use of recycled materials in its vehicle manufacturing. Two exemplary results of this development include Visteon Automotive Systems' recycling of thermoplastic scrap from automobile bumpers and EI du Pont de Nemours and Company's recycling of scrap into automobile air cleaners.Recycled PET, or polyethylene terephthalate, is used in large quantities in food and packaging applications, including beverage bottles.

[0004] There is increasing emphasis on producing medical devices made from recycled plastics to improve the environmental stewardship of medical devices and healthcare agencies' ability to meet environmental goals, such as the Leadership in Environmental Performance (LEED) system, while reducing landfill impact without sacrificing safety. Previous attempts to use recycled resins in the manufacture of medical devices or their components have encountered obstacles such as lack of biocompatibility, lot-to-lot variability in properties, and undesirable changes in appearance during the sterilization process. Furthermore, when recycled resin compositions are used to form fluid-path contacting medical devices, there are concerns that the recycled resin compositions will interfere with materials being transported, conveyed, or delivered through the medical device. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 4,016,118 [Patent Document 2] U.S. Patent No. 4,371,645 [Patent Document 3] U.S. Patent No. 4,994,552 [Patent Document 4] U.S. Patent No. 7,393,590 [Patent Document 5] US Patent Application Publication No. 2008 / 0113887 [Patent Document 6] US Patent Application Publication No. 2008 / 0153940 [Patent Document 7] International Publication No. 07 / 099427 [Patent Document 8] International Publication No. 07 / 063361 [Patent Document 9] European Patent No. 1725614 [Non-patent literature]

[0006] [Non-Patent Document 1] A Holzner, K Chmil in H. Zweifel, Plastic Additives Handbook, 5th Ed., Hanser Publisher, Munich 2001, Chapter 4, Acid Scavengers Summary of the Invention [Problem to be solved by the invention]

[0007] Therefore, there is a need in the industry for a thermoplastic composition comprised of a recycled resin composition that is biocompatible, sterilization-stable, and useful in medical device applications, and such recycled resin compositions are not limited to medical device applications, but can be applied to any industry where such sterilization-stable compositions can be utilized. [Means for solving the problem]

[0008] A first aspect of the present invention relates to a medical device. In one or more embodiments, the medical device is formed from a sterilization-stable recycled resin composition. In more specific embodiments, the medical device can withstand sterilization, including exposure to gamma radiation in the range of about 5 kGys to about 75 kGys. The medical device can withstand sterilization, including exposure to electron beam or x-ray radiation in the range of about 40 kGys to about 100 kGys, exposure to ethylene oxide gas, autoclaving, plasma sterilization, and other types of sterilization. At least some of the medical devices in one or more embodiments include fluid-pathway-contacting medical devices or medical devices that come into contact with liquids.

[0009] In one or more embodiments, the recycled resin composition is biocompatible, as defined above. The composition can include a recycled resin, which can be present in an amount ranging from about 0.1% to about 100% by weight. The recycled resin can include one of post-industrial recycled resin, post-consumer recycled resin, and combinations thereof. In one or more embodiments, the recycled resin composition can include one or more virgin resin components and / or biobased resin components.

[0010] The recycled resin composition may also include one or more antioxidant components, slip additive components, antistatic components, impact modifier components, colorant components, acid scavengers, X-ray fluorescent components, radiopaque fillers, surface modifier components, processing aids, melt stabilizers, clarifiers, and reinforcing components. The antioxidant component may include one or more hindered phenols and hindered amines, and may optionally be present in an amount up to about 10% by weight of the recycled resin composition. Impact modifier components useful in one or more embodiments may include one or more of ethylene-butene copolymers and ethylene-octane copolymers. The acid scavengers may include one or more of calcium stearate, dihydrotalcite, calcium lactate, and monocalcium citrate. The radiopaque fillers may include one or more of barium sulfate, bismuth oxycarbonate, bismuth trioxide, bismuth oxychloride, and tungsten. Furthermore, the colorant component may include organic dyes, inorganic pigments, carbon black, channel black, and titanium dioxide. In one or more embodiments, useful processing aid components may include one or more of fatty acid esters, fatty acid amides, waxes, and oxidized polyethylene. Reinforcement components may include one or more of glass fiber, cinder ash, natural fibers and minerals, carbon fiber, and ceramic fillers, which may be provided as nanoparticles or nanofibers.

[0011] In one or more embodiments, the medical device can include a plunger rod, a needle shield, a handle, and a safety shield. In embodiments where the medical device is a plunger rod, the medical device exhibits functional performance that is acceptable to users, including clinicians. In other words, the plunger rod can exhibit functional performance that is the same as or better than that exhibited by plunger rods formed from non-recycled resin compositions. The medical devices described herein can be formed by molding or extrusion.

[0012] A second aspect of the present invention relates to a composition for molding a medical device. The composition comprises recycled resin sourced from a traceable source and can optionally include antioxidant components, slip additive components, antistatic components, impact modifier components, colorant components, acid scavengers, X-ray fluorescent agents, radiopaque fillers, surface modifier components, processing aids, melt stabilizers, clarifiers, nucleating agents, and reinforcing agents, as separately described above. In one or more embodiments, the composition can withstand exposure to gamma radiation in the range of about 5 kGys to about 75 kGys. In other variations, the composition can withstand exposure to electron beam radiation in the range of about 30 kGys to about 100 kGys. The composition can also withstand exposure to one of x-rays, ethylene oxide gas, autoclaving, and plasma sterilization.

[0013] The composition can be useful in forming the medical devices described herein. The composition can include one or more virgin resin components and bio-based resin components.

[0014] A third aspect of the present invention relates to a method of forming a medical device. In one or more embodiments, the method includes providing a melt-blended composition comprising 50% to 99% recycled resin components, stabilizing the composition to withstand exposure to gamma radiation, electron beam, x-ray, ethylene oxide gas, autoclave, or plasma sterilization, and solidifying the composition into a preselected shape. In one or more embodiments, the method includes stabilizing the composition to withstand exposure to gamma radiation in the range of about 5 kGys to about 75 kGys.

[0015] In one or more embodiments, providing a melt blend includes feeding the recycled resin component and one or more of an antioxidant component, a slip additive component, an antistatic component, an impact modifier component, a colorant component, an acid scavenger component, a nucleating agent, a clarifier, an X-ray fluorescent agent component, a radiopaque filler component, a surface modifier component, a processing aid component, and a reinforcing agent component into a melt compounding extruder. Solidifying the composition can include injection molding the composition, extruding the composition, blow molding the composition, and rotationally molding the composition.

[0016] In one or more embodiments, the composition can be solidified into a preselected shape, including plunger rods, syringe barrels, catheters, blood collection devices, surgical blade handles, needle shields, safety shields, catheter wings, catheter flow control plugs and needle hubs, sharps containers, bodily fluid collection devices, tubing, adapters, and drainage tubes. [Brief explanation of the drawings]

[0017] [Figure 1] FIG. 1 illustrates an exploded view of a syringe assembly in accordance with one or more embodiments of the present invention. [Figure 2] FIG. 1 illustrates a perspective view of a scalpel and scalpel shield according to one or more embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0018] Before describing several exemplary embodiments of the invention, it is to be understood that the invention is not limited to the details of construction or process set forth in the following description. The invention is capable of other embodiments and of being practiced or carried out in various ways.

[0019] As used herein, the term "medical device" is intended to include all devices and components used with other components in devices used for all medical and / or laboratory purposes, excluding waste collection containers such as sharps collection containers. Medical devices include syringe assemblies, including syringe barrels, plunger rods, catheters, needle hubs, and needle shields, safety shields, surgical blades, surgical handles, sharps containers, fluid collection devices, tubing, adapters, shunts, drainage tubes, guidewires, stents, Petri dishes, culture bottles, centrifuge tubes, blood collection devices, and the like. As indicated, as used herein, "medical device" excludes waste collection containers such as sharps collection containers.

[0020] As used herein, the term "biocompatible" means any substance that is not toxic to the body or biological environment or that does not produce an undesirable biological response during exposure to the human body. A composition is biocompatible if the composition and any degradation products of the composition are not toxic to the recipient or biological environment and do not pose significant adverse effects to the recipient or biological environment. A medical device is biocompatible if the degradation products of the medical device are not toxic to the recipient or biological environment and do not pose significant adverse effects to the recipient or biological environment.

[0021] Additionally, as used herein, the term "sterilization stable" refers to the ability of a medical device or component to withstand sterilization without significant loss of functional performance and mechanical properties. Sterilization includes exposure to radiation, e.g., gamma radiation and / or X-rays, during the sterilization process. A medical device or component thereof capable of withstanding radiation sterilization without significant loss of functional performance may be referred to as "radiation stable." One example of a sterilization process includes exposing the medical device to high-energy photons emitted from an isotope source, e.g., cobalt-60, which causes ionization or electron disruption throughout the medical device. Sterilization also includes ethylene oxide sterilization, electron beam sterilization, autoclave (steam sterilization), plasma sterilization, dry heat sterilization, and X-ray beam sterilization.

[0022] As used herein, a "fluid pathway contacting medical device" is a medical device in which at least a portion of the medical device contacts or interacts with fluids and / or solids, such as drugs, drug solutions, drug-containing solutions, flush solutions, bodily fluids, human tissue, or any material intended to be isolated to prevent contamination. As used herein, reference to a medical device "made from a sterilization-stable recycled resin composition" means that the device is manufactured, e.g., shaped, from a resin obtained from recycled resin. Thus, a medical device made from a sterilization-stable recycled resin composition does not include a medical device that has been used and then reprocessed by cleaning or sterilizing part or all of the device by radiation or in an autoclave. While the reuse of such medical devices is often referred to as "reprocessing," reprocessed medical devices are not within the scope of devices made from a sterilization-stable recycled resin composition because such reprocessing does not involve shaping or other manufacturing steps to form the device from the resin composition.

[0023] A first aspect of the present invention relates to a composition for use in molding a medical device comprising recycled resin from a traceable source. A second aspect of the present invention relates to a medical device made from the recycled resin composition. A third aspect of the present invention relates to a method of forming a medical device.

[0024] The recycled resin composition of one or more embodiments of the first aspect may include a post-industrial recycled resin. The amount of post-industrial recycled resin may be present in the recycled resin composition in a range from about 0.1% to about 100% by weight of the recycled resin composition. In one or more embodiments, the recycled resin composition includes a post-industrial recycled resin in an amount ranging from about 50% to about 99% by weight. In one or more specific embodiments, the recycled resin composition may include a post-industrial recycled resin in an amount ranging from about 20% to about 80% by weight. In more specific embodiments, the lower limit of the amount of post-industrial recycled resin may include 25%, 30%, 35%, 40%, 45%, and 50% by weight of the recycled resin composition, as well as all ranges and subranges therebetween. Upper limits for the amount of post-industrial recycled resin can include 75%, 70%, 65%, 60%, 55%, and 50% by weight of the recycled resin composition, and all ranges and subranges therebetween.

[0025] The recycled resin composition of one or more embodiments of the first aspect may include post-consumer recycled resin. The resin may be provided in a suitable format, such as flake, chip, pellet, or the like. In one variation, the recycled resin composition may include post-consumer recycled resin and post-industrial recycled resin. The amount of post-consumer recycled resin may be present in the recycled resin composition in a range from about 0.1% to about 100% by weight of the recycled resin composition. In one or more embodiments, the recycled resin composition includes post-consumer recycled resin in an amount ranging from about 50% to about 99% by weight. In one or more specific embodiments, the recycled resin composition may include post-consumer recycled resin in an amount ranging from about 20% to about 80% by weight. In more specific embodiments, the lower limit of the amount of post-consumer recycled resin may include 25%, 30%, 35%, 40%, 45%, and 50% by weight of the recycled resin composition, and all ranges and subranges therebetween. The upper limit of the amount of post-consumer recycled resin may include 75%, 70%, 65%, 60%, 55%, and 50% by weight of the recycled resin composition, and all ranges and subranges therebetween.

[0026] Examples of suitable post-industrial recycled and post-consumer recycled resins include polypropylene, polycarbonates, nylons, polyethylene terephthalates, polyesters, polyethylenes, polystyrenes, polylactic acid, polyhydroxyalkanoates, bio-based polyolefins including polyethylene and polypropylene, and other resins known in the art to be recyclable, and combinations thereof. Such recycled resins may be recovered or derived from solid waste streams, either during the manufacturing process (pre-consumer) or after consumer use (post-consumer).

[0027] In one or more embodiments, the recycled resin composition may also include one or more optional additives selected from the group consisting of antioxidants, slip additives, antistatic agents, impact modifiers, colorants, acid scavengers, x-ray fluorescent agents, radiopaque fillers, surface modifiers, processing aids including melt stabilizers, nucleating agents including clarifiers, flame retardants, inorganic fillers other than finely divided talc, organic fillers and other polymers, and reinforcing agents.

[0028] In one or more embodiments, the recycled resin composition includes an antioxidant component. The antioxidant component may include a compound that inhibits oxidation through chain termination. In one or more embodiments, the antioxidant component may be present in the recycled resin composition in an amount up to about 10% by weight of the recycled resin composition. In one or more specific embodiments, the recycled resin composition may include an antioxidant component in an amount up to about 5% by weight of the recycled resin composition, or more specifically, up to about 1% by weight. In one or more specific embodiments, the antioxidant component may be present in an amount ranging from about 1% to about 5% by weight of the recycled resin composition. In even more specific embodiments, the antioxidant component may be present in an amount ranging from about 0.1% to about 1% by weight of the recycled resin composition. Upper limits for the amount of the antioxidant component may include 0.9%, 0.8%, 0.7%, 0.6%, and 0.5%, and all ranges and subranges therebetween.

[0029] In one or more embodiments, the antioxidant component is present in an amount sufficient to inhibit oxidative reactions during sterilization and storage and / or use of the product.

[0030] Non-exclusive examples of suitable antioxidant components include hindered phenols, hindered amines, phosphites, and / or combinations thereof. Hindered phenols include compounds that act as hydrogen donors and react with peroxy radicals to form hydroperoxides and prevent hydrogen abstraction from the polymer backbone. Suitable hindered phenols include butylated hydroxytoluenes. Other suitable hindered phenols are currently available from Ciba, Inc., part of BASF, Ludwigshafen, Germany, under the trademarks Irganox® 1076, Irganox® 1010, and Irganox® E 201. Other examples of hindered phenols include BNX® 1010 and BNX® 1076TF from Mayzo Inc. or Norcross, Georgia, USA. Suitable hindered phenols are also available from Albemarle Corporation of Baton Rouge, Louisiana, USA under the trademarks Ethanox® 330 and Ethanox® 376.

[0031] Hindered amines include compounds containing an amine functional group surrounded by a bulky environment. They are highly effective stabilizers against light-induced degradation of most polymers. Examples of suitable hindered amines include bis(1,2,2,6,6-pentamethyl-4-piperidinyl)-2-n-butyl-2-(3,5-di-tert-butyl-4-hydroxybenzyl)malonate; bis(2,2,6,6-tetramethyl-4-piperidinyl)sebacate; bis(1,2,3,6,6-pentamethyl-4-piperidinyl)sebacate and bis(1,2,2,6,6-pentamethyl-4-piperidinyl)sebacate. These are commonly referred to as Tinuvin 144, Tinuvin 770, Tinuvin 292, and Tinuvin 765, respectively, and are available from Ciba-Geigy Corporation, now part of BASF, Ludwigshafen, Germany. Other examples of suitable hindered amines are available under the trade names Uvasorb HA-88 from 3V Sigma SpA, Bergamo, Italy, and Chimassorb 944 and Chimassorb 994 from BASF, Ludwigshafen, Germany.

[0032] In certain embodiments, the recycled resin composition includes a slip additive component. The slip additive component can include compounds used to reduce the surface coefficient of friction of a polymer and improve either processing or end-use applications. The slip additive component is present in the recycled resin composition in an amount ranging from about 0.001% to about 5% by weight of the recycled resin composition, and all ranges and subranges therebetween. In one or more specific embodiments, the slip additive component is present in an amount ranging from about 1% to about 2% by weight of the recycled resin composition. Upper limits for the amount of the slip additive component can include 4.5%, 4.0%, 3.5%, 3.0%, and 2.5% by weight of the recycled resin composition, and all ranges and subranges therebetween. The lower limit for the amount of slip additive component can include 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, and 0.9% by weight of the recycled resin composition, and all ranges and subranges therebetween. Examples of suitable slip additive components include oleamides, erucamide, oleyl palmitamide, stearyl erucamide, ethylene-bis-oleamide, waxes, and combinations thereof.

[0033] The recycled resin composition optionally includes an antistatic component. The antistatic component can include compounds that prevent or reduce static buildup. The antistatic component acts to render the bulk or surface of the material static dissipative, preventing the buildup of static charges and preventing dust adhesion. The antistatic component can be incorporated into the material prior to molding or applied after molding, and can be functionalized by inherent static dissipation or by absorbing moisture from the air. The antistatic component can be present in the recycled resin composition in an amount ranging from about 0.01% to about 5% by weight of the recycled resin composition, and all ranges and subranges therebetween. In one or more specific embodiments, the antistatic component is present in an amount ranging from about 0.1% to about 3.0% by weight of the recycled resin composition, and all ranges and subranges therebetween. The upper limits of the amount of the antistatic component are 4.5%, 4.0%, 3.5%, 3.0%, and 2.5% by weight of the recycled resin composition, including all ranges and subranges therebetween. The lower limits of the amount of the antistatic component are 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, and 1.0% by weight of the recycled resin composition, including all ranges and subranges therebetween. The antistatic component is a long-chain aliphatic amine and amide, a phosphate ester, a quaternary ammonium salt, polyethylene glycols, polyethylene glycol ethers, ethoxylated long-chain aliphatic amines, and combinations thereof.Other examples of suitable antistatic agents are available under the trade names Pelestat 230 and Pelestat 300 from Toyota Tsusho Corporation of Nagoya, Japan, Atmer™ from Croda International Plc of Yorkshire, England, UK, Entira™ MK 400 from E.I. DuPont de Nemours and Company of Wilmington, Delaware, USA, and Nourymix® AP 375 and 775 from Akzo Nobel NV of Amsterdam, the Netherlands.

[0034] The recycled resin composition optionally includes an impact modifier component. The impact modifier component can be included in a compound to improve the impact resistance of a finished product or device. The impact modifier component can be present in the recycled resin composition in an amount ranging from about 0.1% to about 30% by weight of the recycled resin composition. In one or more specific embodiments, the impact modifier component is present in an amount ranging from about 0.5% to about 5% by weight of the recycled resin composition, and all ranges and subranges therebetween. Upper limits for the amount of impact modifier component include 4.5%, 4.0%, 3.5%, 3.0%, 2.5%, and 2.0% by weight of the recycled resin composition, and all ranges and subranges therebetween. The lower limit for the amount of impact modifier component can include 0.75%, 1.0%, 1.25%, 1.5%, 1.75%, and 2.0% by weight of the recycled resin composition, and all ranges and subranges therebetween. Examples of suitable impact modifier components include ethylene-butene copolymers, ethylene octene copolymers, ethylene-propylene copolymers, methacrylate butadiene-styrene core-sheath impact modifiers, and combinations thereof. Examples of suitable impact modifiers are available under the trade names Elvaloy® EAC 3427 from EI DuPont de Nemours and Company, Wilmington, Delaware, USA, Engage™ and Versify™ from Dow Chemical Company, Midland, Michigan, USA, and Clearstrength™ from Arkema Inc., Philadelphia, Pennsylvania, USA.

[0035] When present, the impact modifier component may be present in an amount sufficient to meet the impact requirements of the fabricated medical product.

[0036] The recycled resin composition optionally includes an acid scavenger component. The acid scavenger component can include compounds to prevent discoloration or premature aging of the polymer and protect manufactured medical products from acidic impurities during manufacturing, processing, sterilization, storage, or use. For example, such compounds can neutralize halogen anions found in the resin composition that may form due to the effects of heat and shear during processing. The acid scavenger component scavenges these halogen acids and prevents degradation or corrosion of the polymer. The acid scavenger component can be present in the recycled resin composition in an amount ranging from about 0.01% to about 1% by weight of the recycled resin composition. In one or more specific embodiments, the acid scavenger component is present in an amount ranging from about 0.1% to about 0.5% by weight of the recycled resin composition, including all ranges and subranges therebetween. The upper limit of the amount of the acid scavenger component can include 0.6%, 0.7%, 0.8%, and 0.9% by weight of the recycled resin composition, and all ranges and sub-ranges therebetween.The lower limit of the amount of the acid scavenger component can include 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, and 0.09% by weight of the recycled resin composition, and all ranges and sub-ranges therebetween. Examples of suitable acid scavenger components include metal salts of long-chain carboxylic acids such as calcium, zinc, or sodium stearates and lactates, natural or synthetic silicates such as hydrotalcite, metal oxides (e.g., magnesium oxide, calcium oxide, zinc oxide), metal carbonates (e.g., calcium carbonate), or metal hydroxides (see, for example, A. Holzner, K. Chmil in H. Zweifel, Plastic Additives Handbook, 5th Ed., Hanser Publishers, Munich 2001, Chapter 4, Acid Scavengers (Non-Patent Document 1)).

[0037] When present, the acid scavenger component may be present in the recycled resin composition in an amount sufficient to inhibit discoloration and prevent premature aging caused by acidic impurities during the manufacturing, processing, sterilization, storage, or use stages of the polymer and medical products made therefrom.

[0038] Another optional component of the recycled resin composition is a radiopaque filler component. The radiopaque filler component may include a compound that allows a medical device formed from the resin composition to be visualized by fluoroscopy or x-ray imaging. The radiopaque filler component may be present in the recycled resin composition in an amount ranging from about 10% to about 48% by weight of the recycled resin composition, and all ranges and subranges therebetween. In one or more specific embodiments, the radiopaque filler component is present in an amount ranging from about 22% to about 25% by weight of the recycled resin composition, and all ranges and subranges therebetween. Upper limits for the amount of the radiopaque filler component may include 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, 42%, 44%, and 46% by weight of the recycled resin composition, and all ranges and subranges therebetween. The lower limit of the amount of radiopaque filler component may include 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, and 20% by weight of the recycled resin composition, including all ranges and subranges therebetween. Higher percentages of radiopaque filler component may also be used. For example, the amount of radiopaque filler component may be greater than about 50% by weight of the recycled resin composition. Examples of suitable radiopaque filler components include barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, tungsten, and combinations thereof.

[0039] The radiopaque filler component may be present in an amount sufficient to allow visualization of the medical device using x-ray and other radiological imaging techniques.

[0040] The recycled resin composition optionally further includes a surface modifier component. The surface modifier component may include compounds or materials that modify the surface of the resulting part(s) to suit or enhance adhesive, lubricating, and / or physical properties. The surface modifier component may be present in the recycled resin composition in an amount ranging from about 0.1% to about 10% by weight of the recycled resin composition. In one or more specific embodiments, the surface modifier component is present in an amount ranging from about 0.5% to about 5% by weight of the recycled resin composition, more preferably between 0.2 and 1% by weight, and all ranges and subranges therebetween. Upper limits for the amount of the surface modifier component may include 1.5%, 2.0%, 3.0%, 3.5%, 4.0%, and 4.5% by weight of the recycled resin composition, and all ranges and subranges therebetween. The lower limit for the amount of the surface modifier component may include 0.3%, 0.35%, 0.4%, and 0.45% by weight of the recycled resin composition, and all ranges and subranges therebetween. In one or more embodiments, higher percentages of surface modifier may be used. Examples of suitable surface modifier components include diatomaceous earth, talc, calcium carbonate, organosilanes, titanates, maleated polyolefins, powdered PTFE, and combinations thereof.

[0041] The surface modifier may be present in the recycled resin composition in an amount sufficient to impart the desired surface properties to the surface of the fabricated medical device.

[0042] In one or more embodiments, the recycled resin composition includes a colorant component. The colorant component(s) are present in the recycled resin composition in an amount ranging from about 0.01% to about 5% by weight of the recycled resin composition. In one or more specific embodiments, the colorant component(s) are present in an amount ranging from 0.5% to about 3% by weight of the recycled resin composition, and all ranges and subranges therebetween. Upper limits for the amount of colorant component may include 3.25%, 3.5%, 3.75%, 4.0%, 4.25%, 4.5%, and 4.75% by weight of the recycled resin composition, and all ranges and subranges therebetween. The lower limit of the amount of the colorant component is 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4%, and 0.45% by weight of the recycled resin composition, including all ranges and subranges therebetween. Examples of suitable colorant components include organic dyes, inorganic pigments, carbon black, channel black, titanium dioxide, and combinations thereof. Organic dyes may include phthalocyanine blue and phthalocyanine green, and FD&C colorants. Exemplary inorganic pigments include ultramarines and iron oxides.

[0043] Another optional component of the recycled resin composition includes a processing aid component. The processing aid component may include compounds that improve the processability of high molecular weight polymers, reduce cycle time, and help improve the quality of the finished product. The processing aid component may be present in the recycled resin composition in an amount ranging from about 0.05% to about 5% by weight of the recycled resin composition, and all ranges and subranges therebetween. In one or more specific embodiments, the processing aid component is present in an amount ranging from about 0.1 to about 3% by weight of the recycled resin composition, and all ranges and subranges therebetween. The upper limit for the amount of the colorant component may include 3.25%, 3.5%, 3.75%, 4.0%, 4.25%, 4.5%, and 4.75% by weight of the recycled resin composition, and all ranges and subranges therebetween. Lower limits for the amount of colorant component may include 0.06%, 0.07%, 0.08%, and 0.09% by weight of the recycled resin composition, and all ranges and subranges therebetween. Higher percentages of processing aids may also be used. Examples of suitable processing aid components include fatty acid esters, fatty acid amides, waxes, oxidized polyethylenes, colloidal fumed silica particles, and combinations thereof. Colloidal fumed silica particles are available from Energy Strategy Associates, Inc., Old Chatham, New York, USA, under the trade name Nan-O-Sil ASD. Glycerol monostearates and bisstearamides are suitable fatty acid esters and fatty acid amides.

[0044] The recycled resin composition may include a nucleating agent and / or clarifier component. Nucleating agents may include compounds that enhance resin performance properties, such as stiffness and heat resistance. In one or more embodiments, the nucleating agent and / or clarifier component is present in an amount ranging from about 0.005% to about 3% by weight of the recycled resin composition. Higher percentages of nucleating agent and / or clarifier can be used, but generally do not provide any noticeable benefit. In one or more specific embodiments, the clarifier component is present in an amount ranging from about 0.05 to about 0.5% by weight of the recycled resin composition, and all ranges and subranges therebetween. Upper limits for the amount of clarifier component may include 1.0%, 1.5%, 2.0%, and 2.5% by weight of the recycled resin composition, and all ranges and subranges therebetween. The lower limit of the amount of the clarifier component can include 0.01%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, and 0.045% by weight of the recycled resin composition, and all ranges and subranges therebetween. Examples of clarifier components include dibenzylidene sorbitol, as described in U.S. Pat. No. 4,016,118, which is incorporated herein by reference, substituted dibenzylidene sorbitol, as described in U.S. Pat. No. 4,371,645, which is incorporated herein by reference, and dibenzylidene sorbitol thioether derivatives, as described in U.S. Pat. No. 4,994,552, which is incorporated herein by reference.

[0045] If present, the clarifier may be present in an amount sufficient to prevent light scattering, which would cause the crystal size in the resulting resin composition to be smaller than the wavelength of visible light and become opaque.

[0046] The recycled resin composition optionally includes a reinforcing agent component. The reinforcing agent component may be present in the recycled resin composition in an amount ranging from about 1% to about 35% by weight of the recycled resin composition. In one or more specific embodiments, the reinforcing agent component(s) may be present in an amount ranging from about 5% to about 30% by weight of the recycled resin composition, and all ranges and subranges therebetween. Upper limits for the amount of the reinforcing agent component may include 30.5%, 31%, 31.5%, 32%, 32.5%, 33%, 33.5%, 34%, and 34.5% by weight of the recycled resin composition, and all ranges and subranges therebetween. Lower limits for the amount of the reinforcing agent component may include 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, and 4.5% by weight of the recycled resin composition, and all ranges and subranges therebetween. Examples of suitable reinforcing components include glass fiber, cinder ash, natural fibers and minerals, carbon fiber, ceramic fiber, and combinations thereof. Examples of natural fibers include flax fiber and kenaf fiber, and fillers. The reinforcing component may be present in the recycled resin composition in the form of nanofibers and / or nanoparticles.

[0047] The recycled resin composition according to one or more embodiments can optionally include a melt stabilizer component, which can include compounds to adjust the viscosity of the recycled resin composition during melt processing.

[0048] The recycled resin composition may also incorporate a non-recycled resin component. Examples of non-recycled resin components include a virgin resin component, a bio-based resin component, and combinations thereof. A virgin resin component is a resin composition that does not contain a significant amount of recycled resin. In one or more embodiments, the virgin resin component does not contain recycled resin. The virgin resin component may also include a "fossil fuel-based polymer" or petroleum-based polymer (these terms are used interchangeably), which includes, but is not limited to, polymers formed from non-renewable sources, such as fossil fuel sources. Such polymers include polypropylene, polyethylene, polycarbonate, and polypropylene that are not derived from sugar or other renewable resources.

[0049] The term "biobased" may be used interchangeably with the terms "bioformed" and "bioderived." Biobased components include polymers that are derived, manufactured, or synthesized, in whole or in significant part, from biological sources or from renewable domestic agricultural materials (including plants, animals, and marine materials). Biobased components include polymers in which the carbon is derived from renewable resources through biological processes such as microbial fermentation. Biobased components can also include polymers using different grades of cellulose-based materials. Biobased components can also include polymers that are substantially free of materials derived from fossil fuels or non-renewable resources, as measured by ASTM D6866-08.

[0050] As used herein, bio-based components can include polymers derived from biological sources, such as plants, including polysaccharide-derived polymers, such as starch- or carbohydrate-derived polymers, and sugar-derived polymers. Starches used to form bio-formed polymers can be derived from corn, potato, wheat, cassava, rice, and other plants. Examples of compositions containing starch-derived bio-formed polymers are available from Cereplast Inc., Hawthorne, California, USA, under the trademarks and trade names Cereplast Hybrid Resins®, Bio-polyolefins®, or Biopropylene 50™. The sugars used to form such bio-formed polymers are derived from sugarcane. Such sugar-derived polymers include polyethylene, which can be produced from sugarcane-derived ethanol, which is then used to produce ethylene. and such sugar-derived polymers are available from Novamount SPA, Novara, Italy, under the trademark MATER-BI®. Other examples of bioformed polymers are described in U.S. Pat. No. 7,393,590, U.S. Patent Application Publication Nos. 2008 / 0113887 and 2008 / 0153940, WO 07 / 099427 and 07 / 063361, and EP 1725614, each of which is incorporated herein by reference. Specific examples of bioformed polymers include "polylactic acid" or "PLA," which can include synthetic polymers made from sucrose or corn starch.PLA is available from NatureWorks LLC, Minnetonka, Minnesota, USA, under the trade name Ingeo™. Examples utilizing PLA may also include ethylene copolymers, available from EI DuPont de Nemours and Company, Wilmington, Delaware, USA, under the trademark BIOMAX®.

[0051] Biobased components include polymers, which can be produced by microorganisms. Microorganisms produce substances, including polymers, by growing them on feedstocks, including sugar feedstocks. The production of these polymers can also involve bacterial fermentation of sugars or lipids. Biobased components can be further processed or synthesized from natural products. Examples of biobased polymers produced and / or synthesized in this manner include polyhydroxyalkanoates. The term "polyhydroxyalkanoate" or "PHA" includes linear polyesters that are naturally produced by bacterial fermentation of sugars or lipids. Examples of PHA include poly(hydroxybutyrate) and poly(hydroxyvalerate) or "PHBV." PHA can exhibit properties such as elasticity. PHA is available from Metabolix, Inc., Cambridge, Massachusetts, USA, under the trademark MIREL®.

[0052] The recycled resin composition according to one or more embodiments is biocompatible, as defined herein. In one or more embodiments, the recycled resin composition can withstand exposure to gamma radiation, electron beam radiation, x-ray radiation, ethylene oxide gas, dry heat, peroxide gas plasma, peracetic acid, steam autoclave, and other sterilization methods. In one or more embodiments, the recycled resin composition is radiation stable and can withstand exposure to gamma radiation in the range of about 5 kGys to about 75 kGys, or more specifically, in the range of about 25 kGys to about 50 kGys. In one or more embodiments, the recycled resin composition can withstand exposure to electron beam radiation in the range of about 30 kGys to about 80 kGys, or more specifically, in the range of about 40 kGys to about 70 kGys.

[0053] The recycled resin composition according to one or more embodiments has a melt flow rate in the range of about 3 dg / min to about 80 dg / min. In one or more specific embodiments, the recycled resin composition has a melt flow rate in the range of about 8 dg / min to about 40 dg / min. In more specific embodiments, the recycled resin composition has a melt flow rate in the range of about 11 dg / min to about 30 dg / min. As used herein, the term "melt flow rate" refers to the ease with which the recycled resin compositions described herein melt flow.

[0054] The recycled resin compositions described herein can have a flexural modulus, as measured by ASTM D790 test method, in the range of about 70 kpsi to 350 kpsi, and all ranges and subranges therebetween. In one or more specific embodiments, the recycled resin compositions have a flexural modulus in the range of about 100 kpsi to about 300 kpsi. In more specific embodiments, the recycled resin compositions exhibit a flexural modulus in the range of about 130 kpsi to about 270 kpsi.

[0055] The recycled resin composition is characterized by having a notched Izod impact strength, as measured by ASTM D256 test method, in the range of about 0.1 ft-lb / in. to about 4.0 ft-lb / in., and all ranges and sub-ranges therebetween. In one or more embodiments, the recycled resin composition may have a notched Izod impact strength in the range of about 0.2 ft-lb / in. to about 1.5 ft-lb / in. In one or more specific embodiments, the recycled resin composition may have a notched Izod impact strength in the range of about 0.3 ft-lb / in. to about 1.0 ft-lb / in. As used herein, the term "notched Izod impact strength" refers to the ASTM standard method for determining impact strength.

[0056] The recycled resin compositions of one or more embodiments described herein may be characterized by having a heat deflection temperature ranging from about 60°C to about 260°C. As used herein, the term "heat deflection temperature" includes a measure of a polymer's resistance to bending under a given load at elevated temperature. Heat deflection temperature is also known as distortion temperature under load (DTUL) or "heat deflection temperature" (HDT). Two common loads used to measure heat deflection temperature are 0.46 MPa (66 psi) and 1.8 MPa (264 psi), although tests are sometimes performed at higher loads, such as 5.0 MPa (725 psi) or 8.0 MPa (1160 psi). A common ASTM test is ASTM D648, while the analogous ISO test is ISO 75. Tests using a 1.8 MPa load are performed under ISO 75 Method A, while tests using a 0.46 MPa load are performed under ISO 75 Method B. In one or more specific embodiments, the recycled resin composition may have a heat distortion temperature ranging from about 68°C to about 140°C. In more particularly specific embodiments, the recycled resin composition may have a heat distortion temperature ranging from about 70°C to about 95°C. In one or more embodiments utilizing a post-industrial recycled resin component comprising polycarbonate, the recycled resin composition has a heat distortion temperature of about 140°C at a load of 0.46 MPa and 130°C at a load of 1.8 MPa. In one or more embodiments utilizing a post-industrial recycled resin component comprising a reinforcement component comprising nylon and glass fiber, the recycled resin composition has a heat distortion temperature of about 220°C at a load of 0.46 MPa and 200°C at a load of 1.8 MPa. In one or more embodiments utilizing a post-industrial recycled resin component comprising a reinforcement component comprising PET and glass fiber, the recycled resin composition has a heat distortion temperature of about 250°C at a load of 0.46 MPa and 230°C at a load of 1.8 MPa.

[0057] Preparation of the recycled resin composition of the present invention can be accomplished by any suitable blending or mixing means known in the art. The blending step should at least minimally disperse the components within each other. The components can be blended together in a single-stage process or a multi-stage process. In a single-stage process, all components are blended together simultaneously. In a multi-stage process, two or more components are blended together to form a first mixture, and then one or more remaining components are blended with the first mixture. If one or more components remain, these components can be blended in a subsequent mixing step. In one or more embodiments, all components are blended in a single step.

[0058] In one or more alternative embodiments, the recycled polypropylene composition can be prepared by dry blending the individual components and then melt mixing them directly in the extruder used to make the finished product, or pre-mixing them in a separate extruder. Dry blends of the composition can also be directly injection molded without pre-melt mixing.

[0059] The recycled resin compositions disclosed herein can be molded, extruded, or otherwise utilized to form medical devices. In one or more embodiments, the medical devices are disposable. For example, medical devices can be formed from the recycled resin compositions described herein and used for injections, infusions, blood collection, surgical applications, and other applications known in the art. Specific examples of medical devices formed from the recycled resin compositions described herein include syringes (including syringe barrels, needle hubs, plunger rods, needle shields, etc.), safety syringes, catheters, blood collection devices, surgical blades or scalpels, and other such devices and components. In one or more alternative embodiments, the medical device can be molded in whole or in part from the recycled resin composition. For example, the inner surface of a syringe barrel can be formed from a non-recycled resin composition, while the outer surface of the syringe barrel or the finger flange of the syringe barrel can be made from the recycled resin composition. In one or more alternative embodiments, the handle or needle shield of a scalpel can be formed from the recycled resin composition.

[0060] In one or more embodiments, medical devices formed from the recycled resin compositions described herein can be characterized as non-liquid pathway contacting components or medical devices. Specifically, the medical devices and components do not interact with or come into contact with liquids and / or solids, such as drugs, drug solutions, medical solutions containing solutions, flush solutions, bodily fluids, human tissue, or any material intended to be isolated to prevent contamination. Examples of such devices include syringe plunger rods of three-part syringes, needle shields, safety shields and finger flanges of syringe barrels of infusion devices, handles of peripheral intravenous catheters, catheter wings, catheter flow control plugs, etc. Medical devices and components formed from recycled resin compositions can also be characterized as liquid pathway contacting medical devices. Such medical devices or medical device components can include syringe barrels, needle hubs, handles of surgical blades, valve housings, syringe stoppers, plunger rods of two-part syringes, etc.

[0061] Non-limiting examples of medical devices are illustrated in Figures 1 and 2. Figure 1 illustrates a syringe assembly 100, which includes a syringe barrel 110 having an inner surface defining a chamber, a plunger rod 120 disposed within the outer chamber, and a needle hub 130 including a needle cannula 140 for attachment to the syringe barrel. Figure 1 also illustrates an optional needle shield 150 that attaches to the needle hub 130 to protect and cover the needle cannula 140. The plunger rod 120 includes a separate stopper 125 attached to one end of the plunger rod 120, as shown in Figure 1, for sealing a liquid with the inner surface of the syringe barrel. In one or more alternative embodiments, the plunger rod 120 can include a sealing portion (not shown) that functions as a stopper and that can be integrally molded with the plunger rod 120 and therefore formed from the same material as the plunger rod 120. The syringe barrel 110 shown in FIG. 1 also includes a luer fitting 112 at one end of the syringe barrel 110 and a finger flange 114 at the opposite end of the syringe barrel 110 .

[0062] In one variation, the syringe barrel is formed entirely from the recycled resin compositions disclosed herein. Alternatively, luer fixture 112 and / or finger flange 114 can be formed from the recycled resin compositions disclosed herein, while syringe barrel 110 is formed from a known resin composition (which may include virgin and / or bio-based resin components and does not include any recycled resins). In one or more alternative configurations, the inner surface of syringe barrel 110 is coated with known resin composition(s) (which may include virgin and / or bio-based resin components and does not include any recycled resins), while the remainder of syringe barrel 110 is formed from one or more of the recycled resin compositions described herein.

[0063] In one variation, the plunger rod may be formed from the recycled resin composition described herein. In embodiments where plunger rod 120 incorporates a sealing edge (not shown), the sealing edge (not shown) may also be formed from the recycled resin composition described herein. In one or more embodiments, stopper 125 may be formed from an elastomeric material or other known material, while the plunger rod is formed from the recycled resin composition and attached to stopper 125.

[0064] In one or more embodiments, the needle hub 130 can be formed from the recycled resin composition described herein, while the needle cannula 140 can be made from materials known in the art. In one or more alternative configurations, the needle shield 150 can also be formed from the recycled resin composition disclosed herein.

[0065] 2 illustrates a surgical scalpel 200 including an elongated handle 210 and a blade holder 220 for attaching a blade (not shown) to the elongated handle. The surgical scalpel 200 also includes a blade shield 230 that is removably attached to the elongated handle 210 and / or blade holder 220 to protect the blade (not shown). In one or more embodiments, the elongated handle 210, the blade holder 220, and / or the blade shield 230 can be formed from the recycled resin composition disclosed herein.

[0066] In one or more embodiments, medical devices formed from the recycled resin compositions described herein exhibit no change in color after sterilization, as measured by the yellowness index. For example, medical devices can be sterilized as described above and experience no change in color or appearance.

[0067] Medical devices can be formed using a variety of methods known in the art, including, for example, injection molding, blow molding, extrusion, and / or roto or rotational molding. Other methods known in the art can also be used to form the medical device or component.

[0068] Medical devices formed from the described recycled resin compositions can include plunger rods that exhibit functional performance that meets the requirements of the user and / or clinician.

[0069] In one or more embodiments, plunger rods formed from the above-described recycled resin compositions exhibit the same functional performance as plunger rods formed from non-recycled resin compositions or compositions that do not contain any recycled content.

[0070] A third aspect of the present invention relates to methods of forming medical devices and components. In one or more embodiments, the methods include providing a melt blend composition of the recycled resin composition described herein. The methods include stabilizing the melt blend composition and solidifying the composition into a preselected shape, which may include plunger rods, syringe barrels, catheters, blood collection devices, surgical blade handles, needle shields, and needle hubs. In one or more embodiments, stabilizing the melt blend composition includes stabilizing the melt blend composition to withstand exposure to gamma radiation, electron beams, x-rays, and ethylene oxide gas without compromising the functional performance and / or aesthetic appeal of the finished product.

[0071] According to one embodiment, providing a melt blend composition includes subjecting the recycled resin composition and one or more of an antioxidant component, a slip additive component, an antistatic component, an impact modifier component, a colorant component, an acid scavenger component, a melt blend component, a clarifier component, an X-ray fluorescent component, a radiopaque filler component, a surface modifier component, a processing aid component, and a reinforcing agent component to a melt compounding extruder. Solidifying the composition includes one of injection molding the composition, extruding the composition, and rotationally molding the composition.

[0072] Recycled resin compositions, medical devices and components made from such compositions, and methods for making such medical devices and components provide a unique supply chain system that reduces landfill impact.

[0073] The present invention will be further understood by reference to the following non-limiting examples, the scope of which is not limited by these examples. [Example]

[0074] Inventive Formulations 1-6 were prepared by mechanically mixing recycled polypropylene resin with virgin polypropylene resin further containing antioxidants, acid scavengers, and melt stabilizers.

[0075] Inventive Formulation 1 contained 60 wt. % recycled polypropylene Component A and 40 wt. % virgin polypropylene Component A. The virgin polypropylene Component A contained up to 0.8 wt. % antioxidant and melt stabilizer components and up to 0.3 wt. % acid scavenger components.

[0076] Inventive Formulation 2 contained 70% by weight recycled polypropylene Component B and 30% by weight virgin polypropylene Component A as described above.

[0077] Inventive Formulation 3 contained 50% by weight recycled polypropylene Component C and 50% by weight virgin polypropylene Component A as described above.

[0078] Inventive Formulation 4 contained 60 wt. % recycled polypropylene component A and 40 wt. % virgin polypropylene component B. The virgin polypropylene component B contained up to 0.3 wt. % antioxidant component and up to 0.2 wt. % acid scavenger component.

[0079] Inventive Formulation 5 contained 50% by weight recycled polypropylene Component B and 50% virgin polypropylene Component B as described above.

[0080] Inventive Formulation 6 contained 60% by weight recycled polypropylene Component D and 40% by weight virgin polypropylene Component A as described above.

[0081] The physical properties of each of Inventive Compounds 1-6 were analyzed. Specifically, the flexural modulus, tensile strength @ yield, tensile strength @ break, tensile elongation @ yield, tensile elongation @ break, tensile modulus, Izod impact strength, and heat distortion temperature of Inventive Compounds 1-6 were evaluated and are provided below in Table 1. For comparison, typical ranges for the physical properties of the virgin polypropylene component are provided in Table 2.

[0082] Flexural modulus was measured according to ASTM D790-03. Testing was performed on five specimens for each of Inventive Formulations 1-6. Testing was performed on equipment provided by Instru-Met Corp., Rahway, New Jersey, USA, using a crosshead speed of 0.05 in / min and a substrate span length of 2 inches. Specimens were formed using an injection molding process and conditioned at 23°C and 50% relative humidity (RH) for 40 hours before testing. The average flexural modulus measurements for each of the five samples for the Inventive Formulations are provided in Table 1.

[0083] The tensile properties of Inventive Formulations 1-6 were evaluated according to ASTM D638-03. Testing was performed on five specimens for each of Inventive Formulations 1-6. Testing was performed on equipment provided by Instru-Met Corp., Rahway, New Jersey, USA, using a crosshead speed of 2.0 in / min. Type I tensile bar specimens were formed using an injection molding process and conditioned at 23°C and 50% relative humidity (RH) for 40 hours before testing. The average tensile strength@yield, tensile strength@break, tensile elongation@yield, tensile elongation@break, and tensile modulus measurements for each of the five samples for the Inventive Formulations are provided in Table 1.

[0084] The Izod impact strength of Inventive Formulations 1-6 was evaluated according to ASTM D256-02. Testing was performed on 10 specimens for each of Inventive Formulations 1-6. The average Izod impact strength measurements for Inventive Formulations 1-6 are given in Table 1.

[0085] The heat distortion temperatures of inventive formulations 1-6 were evaluated according to ASTM D648-06 under a load of 66 psi using an HDT / Vicat apparatus available from Tinius Olsen, Inc., Horsham, Pennsylvania, USA. The average heat distortion temperatures for inventive formulations 1-6 are given in Table 1.

[0086] [Table 1]

[0087] [Table 2]

[0088] The physical properties of inventive formulations 1-6 are comparable to those of virgin polyolefin resins, as shown in Table 2. Thus, the recycled resin compositions described herein achieve the goal of utilizing recycled resins that are biocompatible and useful in medical device applications without compromising the physical properties of the resulting device.

[0089] Inventive Formulations 1-6 were also analyzed for biocompatibility. Specifically, each of Inventive Formulations 1-6 was analyzed in accordance with American National Standards Institute (ANSI) / Association for the Advancement of Medical Instrumentation (AAMI) / International Organization for Standardization (ISO) 10-993-5 and the United States Pharmacopoeia Bioassay and Analysis, Bioreactivity Test in Vitro. <87> Analyzed according to the United States Pharmacopoeia Biological Reactivity Test in Vitro. <87> The United States Pharmacopoeia In Vitro Biological Reactivity Test is designed to determine the biological reactivity of mammalian cell cultures or specific extracts prepared from the material under test after contact with elastomeric and other plastic materials through direct or indirect patient contact. <87> was carried out for invention formulations 1 to 6.

[0090] Each of the invention formulations 1-6 passed or met the United States Pharmacopoeia criteria for toxicity testing with a zero score, thereby meeting the criteria for preclinical toxicological safety evaluation established by the United States Pharmacopoeia and ISO 10-993-5. All biocompatibility testing was performed in accordance with the principles of Good Laboratory Practice or GLP, according to procedures known in the art.

[0091] Throughout this specification, references to "one embodiment," "an embodiment," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with an embodiment is included in at least one embodiment of the invention. Thus, appearances of phrases such as "in one or more embodiments," "in an embodiment," "in one embodiment," or "in an embodiment" in various places throughout this specification do not necessarily refer to the same embodiment of the invention. Furthermore, particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0092] Although the present invention has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It will be apparent to those skilled in the art that various modifications and variations can be made to the method and apparatus of the present invention without departing from the spirit and scope of the invention. Therefore, the present invention covers modifications and variations provided within the scope of the appended claims and their equivalents.

Claims

1. A recycled resin composition for molding a medical device, (i) post-consumer recycled polypropylene resin; (ii) virgin resin components, bio-based resin components, or combinations thereof; (iii) an antioxidant component in an amount of up to 1% by weight of the recycled resin composition, and an acid scavenger component in an amount of 0.1 to 0.5% by weight of the recycled resin composition; Including, the recycled resin composition is biocompatible and has a cytotoxicity score of zero; A composition comprising the post-consumer recycled polypropylene resin in an amount ranging from 45% to 75% by weight of the recycled resin composition.

2. 10. The composition of claim 1, wherein the composition can withstand exposure to gamma radiation in the range of 5 kGys to 75 kGys, or the composition can withstand exposure to electron beam radiation in the range of 30 kGys to 100 kGys.

3. 10. The composition of claim 1, wherein the composition is capable of withstanding exposure to one of x-rays, ethylene oxide gas, autoclaving, and plasma sterilization.

4. 10. The composition of claim 1, having a flexural modulus in the range of 482.63 MPa to 2413.16 MPa (70 kpsi to 350 kpsi).

5. 10. The composition of claim 1, comprising a melt flow range ranging from 3 dg / min to 80 dg / min.

6. 10. The composition of claim 1, having a heat distortion temperature of from 60°C to 260°C.

7. 10. The composition of claim 1, having a notched Izod impact strength in the range of 5.34 J / m to 213.6 J / m (0.1 ft-lb / in to 4.0 ft-lb / in).

8. 10. The composition of claim 1, wherein the virgin resin component is a fossil fuel-based polymer selected from the group consisting of polypropylene, polyethylene, and polycarbonate.

9. 10. The composition of claim 1, wherein the bio-based resin component is selected from the group consisting of starch-derived polymers, carbohydrate-derived polymers, and sugar-derived polymers.

10. 10. The composition of claim 9, wherein the starch-derived polymer is derived from a group of plants consisting of corn, potato, wheat, cassava, rice and other plants, and the sugar-derived polymer is derived from sugarcane.

11. 10. The composition of claim 9, wherein the bio-based resin component is a polyhydroxyalkanoate produced from a microorganism or from a natural product with further processing or synthesis.

12. 10. The composition of claim 1, wherein the recycled resin composition comprises the post-consumer recycled resin in an amount ranging from 50% to 99% by weight of the recycled resin composition.

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