COMPOSITIONS OF RECYCLED RESIN AND DISPOSABLE MEDICAL DEVICES PREPARED FROM THE ABOVE
Patent Information
- Authority / Receiving Office
- MX · MX
- Patent Type
- Patents
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2014-05-02
- Publication Date
- 2026-06-12
AI Technical Summary
The use of recycled resins in medical devices is hindered by issues such as biocompatibility, variability of properties, and potential interference with fluid pathways, as well as concerns about sterilization stability and batch-to-lot variability.
Development of recycled resin compositions that are biocompatible, sterilization-stable, and suitable for medical device applications, incorporating additives like antioxidants, antistatic agents, and radiopaque fillers, and using methods like gamma ray exposure to ensure stability and performance.
The recycled resin compositions maintain structural integrity and functional performance comparable to non-recycled resins, while reducing environmental impact and meeting safety and regulatory standards.
Abstract
Description
RECYCLED RESIN COMPOSITIONS AND DISPOSABLE MEDICAL DEVICES PREPARED FROM THE ABOVE BACKGROUND OF THE INVENTION The present invention relates to recycled resin compositions, medical devices formed from virgin material or recycled resin compositions, and methods for manufacturing medical devices from virgin material or recycled resin compositions. Specifically, embodiments of the invention are directed to syringe plunger rods manufactured from virgin material, recycled resin compositions, bio-based materials, or combinations thereof, requiring less material while maintaining sufficient structural integrity to function properly. Plastics constitute a significant portion of most disposable medical devices, non-disposable medical devices, medical device packaging materials, and other non-medical device applications, including automotive and everyday products. These include polymers such as polypropylene, polyethylene, polystyrene, polyethylene terephthalate, and polycarbonate, among others. The increased use of plastics over the past few decades has resulted in a greater impact on landfill capacity and the depletion of fossil fuel-based resources. Additionally, waste can also be incinerated, creating a potential air pollution problem. The growing use of plastics has also resulted in an increasing level of environmental pollution, the associated carbon footprint, and other environmental impacts. In light of the above, there is a growing interest in the use of recycled thermoplastic polymer materials, which can be obtained from a variety of sources.The growing interest in the use of recycled thermoplastic polymer materials is driven by numerous factors, including increased user awareness of the environmental protection issue, environmentally preferred purchasing policies developed by users, brand owners' recognition of the marketing benefits derived from environmental stewardship, institutional users purchasing products themselves, the development of new environmental regulations and policies to reduce the carbon footprint, and a desire to reduce the rising costs of storage and / or landfill space linked to restrictive regulations for landfilling and incineration.The growing interest in the use of recycled thermoplastic polymers and thermosets is also driven by the increasing capacity of recyclers to consistently produce high-quality recycled resins. These factors have already resulted in the widespread use of recycled plastics in automotive and food packaging applications. For example, Ford Motor Company has developed ways to increase the use of recycled materials in its vehicle manufacturing. Two illustrative examples of this development include Visteen Automotive Systems, which recycles thermoplastic scrap from car bumpers, and E.I. du Pont de Nemours and Company, which recycles scrap from automotive air purifiers. Recycled PET, or polyethylene terephthalate, is widely used in food and packaging applications, including soft drink bottles. To enhance the environmental management of medical devices and the ability of healthcare organizations to meet environmental objectives, such as the LEED system, while simultaneously reducing landfill impact without compromising safety, there is a growing emphasis on developing compositions for use in the manufacture of medical devices made from recycled plastics. Potential problems arising from the use of recycled resins in the manufacture of medical devices or their components include obstacles such as a lack of biocompatibility, variability in properties between batches, and undesirable changes in appearance during the sterilization process.Additionally, when recycled resin compositions are used to form medical devices in contact with fluid pathways, there is concern that the recycled resin compositions may have batch-to-batch variability, contamination, or may interfere with the material being transmitted, transported, or administered through the medical device. Accordingly, there is an industry need for thermoplastic compositions made from recycled resin that are biocompatible, sterilization-stable, and suitable for medical device applications. These recycled resin compositions are not limited to medical device applications and could be used in any industry that requires such sterilization-stable compositions. SUMMARY One or more embodiments of the invention relate to syringe plunger rods comprising an elongated body, a thumb pusher, and a retaining bracket. The elongated body has a proximal end and a distal end that define a length. The elongated body is formed from a composition comprising one or more of a sterilization-stable recycled resin and a bio-based composition. The thumb pusher is located at the proximal end of the elongated body. The retaining bracket is located at the distal end of the elongated body. In some embodiments, the elongated body comprises at least one rib extending its length, said rib comprising a plurality of separate openings. In detailed embodiments, the elongated body comprises four cross-shaped ribs. In specific embodiments, the plurality of separate openings is located along two of the four ribs. In detailed embodiments, the elongated body comprises three ribs. In specific embodiments, the plurality of separate openings is located along two of the three ribs. In certain embodiments, the plurality of separate openings is located along one of the three ribs. In some embodiments, the elongated body comprises at least two ribs extending the length of the elongated body, and the plurality of separate openings are located on fewer than all of the ribs. In detailed embodiments, the elongated body comprises two v-shaped ribs with a plurality of separate support walls along the length of the elongated body. Some embodiments further comprise a plurality of separate support walls along the length of the elongated body. In one or more embodiments, the elongated body comprises a hollow portion. Specific embodiments further comprise at least one rib inside the hollow portion that extends at least partially along the length of the elongated body. In one detailed embodiment, the hollow portion is shaped substantially similarly to the elongated body. In detailed embodiments, the syringe plunger rod is capable of withstanding sterilization comprising one or more of the following methods: gamma radiation exposure in the range of approximately 5 kGy to approximately 75 kGy, electron beam exposure in the range of approximately 40 kGy to approximately 100 kGy, X-ray radiation exposure, exposure to gaseous ethylene oxide, autoclaving, and plasma sterilization. In specific embodiments, the composition comprises a recycled resin composition having from approximately 0.1% to approximately 100% by weight of recycled resin selected from a resin recycled after manufacturing, a resin recycled after use by the user, and combinations thereof.In certain embodiments, the composition further comprises one or more of an antioxidant component, a slip additive component, an antistatic component, an impact modifier component, a coloring component, an acid sequestering component, an x-ray fluorescence agent component, a radiopaque filler component, a surface modifier component, a processing aid component, a melt stabilizer, clarifying agents, and a reinforcing agent component. The syringe plunger rod of some embodiments exhibits functional behavior that is approximately the same as or greater than that of plunger rods formed from a non-recycled resin composition. In detailed embodiments, the composition has a flexural modulus in the range of approximately 70 kpsi (483 MPa) to approximately 300 kpsi (2068 MPa). In specific embodiments, the composition has a melt flow range of approximately 3 dg / min to approximately 80 dg / min. In certain embodiments, the composition has a thermal deflection temperature of approximately 68°C to approximately 140°C. In one or more embodiments, the composition has an izod notch impact toughness in the range of approximately 0.2 ft-lb / in (5.81 J / m) to approximately 3.0 ft-lb / in (87.15 J / m). In some embodiments, the elongated body is cylindrical and there are a plurality of openings through it separated along the length of the elongated body. Further embodiments of the invention relate to a syringe plunger rod comprising an elongated body, a thumb pusher, and a retaining bracket. The elongated body has a proximal end and a distal end defining a length. The elongated body has at least one opening through it. The thumb pusher is located at the proximal end of the elongated body. The retaining bracket is located at the distal end of the elongated body. The plunger rod is prepared from a composition comprising one or more of a virgin material, a sterilization-stable recycled resin, and a bio-based composition. In some embodiments, the elongated body comprises at least one rib extending the length of the elongated body and a plurality of separate openings along the length of the at least one rib. In detailed embodiments, the elongated body comprises a hollow portion along the length of the elongated body. Specific embodiments further comprise at least one rib extending through the interior of the hollow portion along at least a partial length of the elongated body. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 illustrates an orderly exploded view of a syringe assembly of one or more embodiments of the present invention; Fig. 2 illustrates a perspective view of a scalpel and a scalpel cover according to one or more embodiments; Figs. 3A-3E illustrate a syringe plunger rod according to one or more embodiments of the invention; Figs. 4A-4F illustrate a syringe plunger rod according to one or more embodiments of the invention; Figs. 5A-5F illustrate a syringe plunger rod according to one or more embodiments of the invention; Figs. 6A-6F illustrate a syringe plunger rod according to one or more embodiments of the invention; Figs. 7A-7F illustrate a syringe plunger rod according to one or more embodiments of the invention; Figs. 8A-8F illustrate a syringe plunger rod according to one or more embodiments of the invention; Figs. 9A-9F illustrate a syringe plunger rod according to one or more embodiments of the invention; The Figs. 10A-10F illuminate a syringe plunger rod according to one or more embodiments of the invention; Figures 11A-11F illustrate the invention; Figures 12A-12F illustrate the invention; a rod Figs. 13A-13F illustrate a rod invention; Figures 14A-14F illustrate the invention; Figures 15A-15F illustrate the invention; Figures 16A-16F illustrate the invention; Figs. 17A-17F illustrate a syringe plunger rod according to one or more embodiments of the invention; Figs. 18A-18F illustrate a syringe plunger rod according to one or more embodiments of the invention; Fig. 19 illustrates a syringe plunger rod according to one or more embodiments of the invention; Fig. 20 illustrates a syringe plunger rod according to one or more embodiments of the invention; Fig. 21 illustrates a syringe plunger rod according to one or more embodiments of the invention; Fig. 22A illustrates a syringe plunger rod according to one or more embodiments of the invention; Fig. 22B illustrates the cross-section of the syringe plunger rod of FIG. 22A; Figs. 23A-23F illustrate a syringe plunger rod according to one or more embodiments of the invention; Fig. 24 illustrates a syringe plunger rod according to one or more embodiments of the invention; Fig. 25 illustrates a syringe plunger rod according to one or more embodiments of the invention; Fig. 26A illustrates a syringe plunger rod according to one or more embodiments of the invention; Fig. 26B illustrates the cross-section of the syringe plunger rod of FIG. 26A; Fig. 27 illustrates a syringe plunger rod according to one or more embodiments of the invention; Fig. 28 illustrates a syringe plunger rod according to one or more embodiments of the invention; and Fig. 29 illustrates a syringe plunger rod according to one or more embodiments of the invention. DETAILED DESCRIPTION Before describing some illustrative embodiments of the invention, it should be understood that the invention is not limited to the details of the construction steps or the procedure shown in the following description. The invention is capable of other embodiments and can be practiced or carried out in various ways. As used herein, the term medical device shall include all devices and components used together with other components in devices used for all medical and / or laboratory purposes, excluding waste collection containers such as sharps containers. Medical devices include syringe assemblies, including syringe bodies, plunger rods, catheters, needle connectors and needle guards, safety guards, surgical blades, surgical handles, sharps containers, body fluid collection devices, tubing, adapters, shunts, drainage tubes, guidewires, endoprostheses, petri dishes, culture flasks, centrifuge tubes, blood collection devices, and the like.As stated, as used herein, medical devices exclude waste collection containers such as sharps collection containers. As used herein, the term biocompatible shall mean any substance that is non-toxic to the body or the biological environment or does not produce an undesirable biological response during the period of exposure to the human body. Biocompatible compositions may also be compatible with petri dish and medical assay applications (i.e., laboratory studies) such that the material does not interfere with the biological functions of the organisms being used in the studies. A composition is biocompatible if the composition, and any degradation products thereof, are non-toxic to the recipient or the biological environment and do not present significant detrimental effects on the biological environment, depending on the mode of use (e.g., short-term or long-term use).A medical device is biocompatible if the device, and any degradation products thereof, are non-toxic to the recipient or the biological environment and do not present significant detrimental effects on the biological environment. In detailed embodiments, the biocompatible material meets the requirements of the US Pharmacopeia and / or ISO 10993. Furthermore, as used herein, the term "sterilization stable" shall mean 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, for example, gamma rays and / or X-rays, during the sterilization procedure. Medical devices or their components that are capable of withstanding radiation sterilization without significant loss of functional performance may be referred to as "radiation stable." An example of a sterilization procedure may include exposing a medical device to high-energy photons emitted from an isotope source, for example, Cobalt-60, which produces ionization or electron perturbation throughout the medical device.Sterilization may also include ethylene oxide sterilization, electron beam sterilization, autoclave (steam sterilization), plasma sterilization, dry heat sterilization, chemical sterilization, and X-ray beam sterilization. As used herein, medical devices in contact with fluid pathways are medical devices where at least a portion of the device comes into contact with or interacts with fluids and / or solids, for example, drugs, drug solutions, solutions containing drugs, washing solutions, body fluids, human tissue, or any material that is intended to be isolated to prevent contamination. As used herein, a reference to a medical device formed from a sterilization-stable recycled resin composition means that the device is manufactured, for example, formed from a resin obtained from recycled resin.Accordingly, a medical device formed from a sterilization-stable recycled resin composition does not include the use of a medical device and its subsequent reprocessing by cleaning or sterilizing a portion of the complete device by radiation or in an autoclave. Such reuse of the medical device is often referred to as reprocessing, and reprocessed medical devices are not included within the scope of a device formed from a sterilization-stable recycled resin composition because such reprocessing does not include shaping or other manufacturing processes to form a device from a resin composition. A first aspect of the present invention relates to compositions for use in molding a medical device that includes a resin recycled from a traceable source. A second aspect of the present invention relates to a medical device formed from a recycled resin composition. A third aspect of the present invention relates to a method of forming a medical device. Medical devices, including the syringe plunger rods described, can be prepared from a composition comprising one or more virgin materials, a sterilization-stable recycled resin, and a bio-based composition. The composition may contain individual components of mixed origin (e.g., the same type of plastic with a mixture of virgin and recycled material) or multiple components from the same source (e.g., two types of plastic, both containing virgin material). The recycled resin compositions of one or more embodiments of the first aspect may include resin recycled after industrial use. The amount of resin recycled after industrial use may be present in the recycled resin composition in the range of approximately 0.1% to approximately 100% by weight of the recycled resin composition. In one or more embodiments, the recycled resin composition includes resin recycled after industrial use in an amount in the range of approximately 50% to approximately 99% by weight. In one or more specific embodiments, the recycled resin composition may include resin recycled after industrial use in an amount in the range of approximately 20% to approximately 80% by weight.In a more specific embodiment, the lower limit of the amount of resin recycled after industrial use may include 25%, 30%, 35%, 40%, 45%, and 50% by weight of the recycled resin composition and all intervals and sub-intervals in between. The upper limit of the amount of resin recycled after industrial use may include 75%, 70%, 65%, 60%, 55%, and 50% by weight of the recycled resin composition and all intervals and sub-intervals in between. The recycled resin compositions of one or more embodiments of the first aspect may include post-consumer recycled resin. The resin may be provided in any suitable form, such as flakes, wafers, agglomerates, and the like. In one embodiment, the recycled resin compositions may include post-consumer recycled resin and post-industrial recycled resin. The amount of post-consumer recycled resin present in the recycled resin composition may range from approximately 0.1% to approximately 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 approximately 50% to approximately 99% by weight.In one or more specific embodiments, the recycled resin composition may include post-use recycled resin in an amount ranging from approximately 20% to approximately 80% by weight. In a more specific embodiment, the lower limit of the amount of post-use recycled resin may include 25%, 30%, 35%, 40%, 45%, and 50% by weight of the recycled resin composition and all intervals and sub-intervals in between. The upper limit of the amount of post-use recycled resin may include 75%, 70%, 65%, 60%, 55%, and 50% by weight of the recycled resin composition and all intervals and sub-intervals in between. Examples of post-industrial recycled resins and post-consumer recycled resins include polypropylene, polycarbonates, nylons, polyethylene terephthalates, polyesters, polyethylenes, polystyrenes, polylactic acid, polyhydroxyalkanoates, bio-derived polyolefins including polyethylene and polypropylene, and other resins known to the public domain that are recyclable, and combinations thereof. Recycled resins may have been recovered or otherwise diverted from the solid waste stream, either during the manufacturing process (pre-consumer) or after consumer use (post-consumer). In one or more embodiments, the recycled resin composition may also include one or more of the optional additives. These optional additives are selected from the group consisting of antioxidants, slip agents, antistatic agents, impact modifiers, plasticizers, surfactants, colorants, acid sequestrants, X-ray fluorescence agents, radiopaque fillers, surface modifiers, processing aids including melt stabilizers, nucleating agents including clarifying agents, flame retardants, inorganic fillers other than finely divided talc, organic fillers, and other polymers and reinforcing agents. In one or more embodiments, the recycled resin composition includes an antioxidant component. The antioxidant component may include chemical compounds that inhibit oxidation through chain-termination reactions. In one or more embodiments, the antioxidant component may be present in the recycled resin composition in an amount up to approximately 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 approximately 5% by weight, or more specifically, up to approximately 1% by weight of the recycled resin composition. In one or more specific embodiments, the antioxidant component may be present in an amount ranging from approximately 1% to approximately 5% by weight of the recycled resin composition.In an even more specific embodiment, the antioxidant component may be present in an amount ranging from approximately 0.1% to approximately 1% by weight of the recycled resin composition. The upper limit of the amount of the antioxidant component may include 0.9%, 0.8%, 0.7%, 0.6%, and 0.5%, and all intervals and sub-intervals in between. In one or more embodiments, the antioxidant component is present in a sufficient quantity to inhibit oxidation reactions during sterilization and during the half-life and / or use phase of the product. Non-exclusive examples of suitable antioxidant components include hindered phenols, hindered amines, phosphites, and / or combinations thereof. Hindered phenols include chemical compounds that act as hydrogen donors and react with peroxy radicals to form hydroperoxides, thus preventing the abstraction of hydrogen from the polymer structure. Suitable hindered phenols include butylated hydroxytoluene. Other suitable hindered phenols are available under the brand names Irganox® 1076, Irganox® 1010, Irganox® 3114, and Irganox® E 201 from Giba, Inc., now part of BASF Corporation of Ludwigshafen, Germany. Other examples of hindered phenols include BNX®1010 and BNX®1076TF from Mayzo Inc. of Norcross, Georgia, USA. Suitable hindered phenols are also available under the brand names Ethanox®330 and Ethanox®376 from Albemarle Corporation of Baton Rouge, Louisiana, USA. Hindered amines include chemical compounds containing a functional amino group surrounded by a steric environment. They are extremely 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 Corporation in Ludwigshafen, Germany. Other examples of suitable hindered amines are available under the trade names Uvasorb HA-88 from 3V Sigma SpA of Bergamo, Italy, and Chimassorb 944 and Chimassorb 994 from BASF Corporation in Ludwigshafen, Germany. In specific embodiments, the recycled resin compositions include a slip additive component. The slip additive component may include chemical compounds that reduce the surface friction coefficient of the polymers and are used to enhance both processing and end applications. The slip additive component may be present in the recycled resin composition in an amount ranging from approximately 0.001% to approximately 5% by weight of the recycled resin composition and all intervals and sub-intervals in between. In one or more specific embodiments, the slip additive component is present in an amount ranging from approximately 1% to approximately 2% by weight of the recycled resin composition.The upper limit for the amount of the slip additive component may include 4.5%, 4.0%, 3.5%, 3.0%, and 2.5% by weight of the recycled resin composition, and all intervals and sub-intervals between them. The lower limit for the amount of the slip additive component may 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 intervals and sub-intervals between them. Examples of slip additive components include oleamides, erucamide, oleyl palmitamide, stearyl erucamide, ethylenebisoleamide, waxes, and combinations thereof. The recycled resin composition optionally includes an antistatic component. The antistatic component may include chemical compounds that prevent or reduce the buildup of static electricity. The antistatic component allows the body or surface to act as a static charge dissipator, preventing the formation of static charges and the adhesion of dust. The antistatic component can be incorporated into the material before molding or applied to the surface after molding and can function either by inherently dissipating static charge or by absorbing moisture from the air. The antistatic component may be present in the recycled resin composition in an amount ranging from approximately 0.01% to approximately 5% by weight of the recycled resin composition, including all intervals and sub-intervals in between.In one or more specific embodiments, the antistatic component is present in an amount ranging from approximately 0.1% to approximately 3.0% by weight of the recycled resin composition, including all intervals and sub-intervals in between. The upper limit of the amount of the antistatic component may include 4.5%, 4.0%, 3.5%, 3.0%, and 2.5% by weight of the recycled resin composition, including all intervals and sub-intervals in between. The lower limit of the amount of the antistatic component may include 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 intervals and sub-intervals in between. Examples of components of antistatic agents are long-chain aliphatic amines and amides, phosphate esters, quaternary ammonium salts, polyethylene glycols, polyethylene glycol esters, ethoxylated long-chain aliphatic amines and their combinations.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™ 163 from Uniqema, currently part of Croda International Pie of Yorkshire, England, UK, Entira™MK 400 from The DuPont de Nemours and the Company of Wilmington, Delaware, USA, and Nourymix® AP 375 and 775 from Akzo Nobel NV of Amsterdam, Netherlands. The recycled resin composition optionally includes an impact modifier component. The impact modifier component may include chemical compounds to improve the impact resistance of the finished articles or devices. The impact modifier component may be present in the recycled resin composition in the range of approximately 0.1% to approximately 30% by weight of the recycled resin composition. In one or more specific embodiments, the impact modifier component is present in an amount in the range of approximately 0.5% to approximately 5% by weight of the recycled resin composition and all intervals and sub-intervals in between. The upper limit of the amount of the impact modifier component may include 4.5%, 4.0%, 3.5%, 3.0%, 2.5%, and 2.0% by weight of the recycled resin composition and all intervals and sub-intervals in between.The lower limit for the amount of the impact modifier component may include 0.75%, 1.0%, 1.25%, 1.5%, 1.75%, and 2.0% by weight of the recycled resin composition, and all intervals and sub-intervals in between. Examples of suitable impact modifiers include ethylene-butene copolymers, ethylene-octene copolymers, ethylene-propylene copolymers, impact modifiers with a coated butadiene-styrene methacrylate core, and combinations thereof. Examples of suitable impact modifiers are available under the trade names Elvaloy® EAC3427 from DuPont de Nemours and Company of Wilmington, Delaware, USA; Engage™ and Versify™ from Dow Chemical Company of Midland, Michigan, USA; and Clearstrength™ from Arkema Inc. of Philadelphia, Pennsylvania, USA. When present, the impact modifier component may be present in a sufficient quantity to meet the impact requirements of the manufactured medical article. The recycled resin composition optionally includes an acid sequestering component. This acid sequestering component may consist of chemical compounds designed to prevent discoloration or premature aging of the polymer and the manufactured medical device resulting from acidic impurities during manufacturing, processing, sterilization, storage, or use. For example, such chemical compounds may neutralize halogen anions present in the resin composition that can form due to heat and shear stress during processing. The acid sequestering component binds these halogen acids to prevent polymer degradation or corrosion. The acid sequestering component may be present in the recycled resin composition in an amount ranging from approximately 0.01% to approximately 1% by weight.In one or more specific embodiments, the acid-sequestering component is present in an amount ranging from approximately 0.1% to approximately 0.5% by weight of the recycled resin composition, including all intervals and sub-intervals in between. The upper limit of the amount of the acid-sequestering component may include 0.6%, 0.7%, 0.8%, and 0.9% by weight of the recycled resin composition, including all intervals and sub-intervals in between. The lower limit of the amount of the acid-sequestering component may 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, including all intervals and sub-intervals in between.Examples of suitable acid-scavenging components include metal salts of long-chain carboxylic acids such as calcium, zinc, or sodium stearates, lactates, natural or synthetic silicates of the hydrotalkite type, 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 Publisher, Munich 2001, Chapter 4 Acid Scavengers). Suitable examples of acid sequestrants include calcium stearate, dihydrotalkite, calcium lactate, monopotassium citrate, and combinations thereof. When present, the acid-sequestering component may be present in the recycled resin composition in a sufficient quantity to inhibit discoloration and prevent degradation caused by acid impurities during the manufacturing, processing, storage, shelf life or use phases of the polymer and the medical article manufactured from the former. Another optional component of the recycled resin composition is a radiopaque filler component. The radiopaque filler component may include chemical compounds that make medical devices formed from the resin composition visible under fluoroscopic or x-ray imaging. The radiopaque filler component may be present in the recycled resin composition in an amount ranging from approximately 10% to approximately 48% by weight of the recycled resin composition, including all intervals and sub-intervals in between. In one or more specific embodiments, the radiopaque filler component is present in an amount ranging from approximately 22% to approximately 25% by weight of the recycled resin composition, including all intervals and sub-intervals in between.The upper limit for the amount of radiopaque filler may include 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, 42%, 44%, and 46% by weight of the recycled resin composition, and all intervals and sub-intervals between them. The lower limit for the amount of radiopaque filler may include 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, and 20% by weight of the recycled resin composition, and all intervals and sub-intervals between them. Higher percentages of radiopaque filler component may also be used. For example, the amount of radiopaque filler component may be more than approximately 50% of the recycled resin composition. Examples of radiopaque charge components include barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, tungsten, and combinations thereof. The radiopaque charging component may be present in a sufficient quantity to allow visibility of medical devices by using x-rays and other radiological imaging techniques. The recycled resin composition optionally includes a surface modifier. The surface modifier may include compounds or chemical materials that adapt the surface of the manufactured component(s) to satisfy or enhance adhesion, lubrication, and / or physical properties. The surface modifier may be present in the recycled resin composition in an amount ranging from approximately 0.1% to approximately 10% by weight of the recycled resin composition. In one or more specific embodiments, the surface modifier is present in an amount ranging from approximately 0.5% to approximately 5%, more preferably 0.2% to 1% by weight of the recycled resin composition, and all intervals and sub-intervals in between.The upper limit for the amount of the surface modifier component may include 1.5%, 2.0%, 3.0%, 3.5%, 4.0%, and 4.5%, and all intervals and sub-intervals between them. 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 intervals and sub-intervals between them. In one or more embodiments, higher percentages of surface modifiers may also be used. Examples of surface modifiers include diatomaceous earth, talc, calcium carbonate, organosilanes, titanates, maleated polyolefins, powdered PTFE, and combinations thereof. The surface modifier may be present in the recycled resin composition in a sufficient quantity to impart desirable surface properties to the surface of the desired medical device. In one or more embodiments, the recycled resin composition includes a coloring component. The coloring component may be present in the recycled resin composition in an amount ranging from approximately 0.01% to approximately 5% by weight of the recycled resin composition. In one or more specific embodiments, the coloring component(s) are present in an amount ranging from approximately 0.5% to approximately 3% by weight of the recycled resin composition, including all intervals and sub-intervals in between. The upper limit of the amount of the coloring 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, including all intervals and sub-intervals in between.The lower limit for the quantity of the antistatic component may include 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4%, and 0.45% by weight of the recycled resin composition, and all intervals and sub-intervals in between. Examples of suitable coloring components include organic dyes, inorganic pigments, carbon black, carbon black, titanium dioxide, and combinations thereof. Organic dyes may include phthalocyanine blue and phthalocyanine green, and FD&C dyes. Illustrative inorganic pigments include ultramarines and iron oxides. Another optional component of the recycled resin composition is a processing aid. The processing aid may include chemical compounds that improve the processability of high molecular weight polymers, reduce cycle time, and help improve the quality of finished products. The processing aid may be present in the recycled resin composition in an amount ranging from approximately 0.05% to approximately 5% by weight of the recycled resin composition, including all intervals and sub-intervals in between. In one or more specific embodiments, the processing aid is present in an amount ranging from approximately 0.1% to approximately 3% by weight of the recycled resin composition, including all intervals and sub-intervals in between.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 intervals and sub-intervals in between. The lower limit for the amount of the antistatic component may include 0.06%, 0.07%, 0.08%, and 0.09% by weight of the recycled resin composition, and all intervals and sub-intervals in between. Higher percentages of processing aids may also be used. Examples of suitable processing aids include fatty acid esters, fatty acid amines, waxes, oxidized polyethylenes, pyrolyzed colloidal silica particles, and combinations thereof. Pyrolyzed colloidal silica particles are available under the trade name Nan-O-Sil ASD from Energy Strategy Associates, Inc. of Old Chatham, New York, USA and other suppliers.Glycerol monostearates and bistearamides are suitable fatty acid esters and fatty acid amides. The recycled resin composition may optionally include nucleating agents and / or a clarifying component. Nucleating agents may include chemical compounds that enhance resin performance properties such as stiffness and heat resistance. A clarifying agent may also be added to enhance the aesthetic appeal of a formed product by making it more transparent. In one or more embodiments, the nucleating and / or clarifying component is present in an amount ranging from approximately 0.005% to approximately 3% by weight of the recycled resin composition. Higher percentages of nucleating and / or clarifying agents may be used but do not generally provide any perceived advantages.In one or more specific embodiments, the clarifying component is present in an amount ranging from approximately 0.05% to approximately 0.5% by weight of the recycled resin composition, including all intervals and sub-intervals in between. The upper limit of the amount of the clarifying component may include 1.0%, 1.5%, 2.0%, and 2.5% by weight of the recycled resin composition, including all intervals and sub-intervals in between. The lower limit of the amount of the clarifying component may 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, including all intervals and sub-intervals in between. Examples of clarifying components include dibenzylidene sorbitol as described in United States Patent No. 4,016.118, which is incorporated by reference herein, Dibenzylidene sorbitol as described in United States Patent No. 4,371,645, which is incorporated by reference herein, and dibenzylidene sorbitol thioether derivatives as described in United States Patent No. 4,994,552, which is incorporated by reference herein. When present, clarifiers may be present in a sufficient quantity so that the crystal size in the resulting resin composition is smaller than the wavelength of visible light to prevent light scattering, which produces opacity. 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 approximately 1% to approximately 35% by weight of the recycled resin composition. In one or more specific embodiments, the reinforcing agent component(s) are present in an amount ranging from approximately 5% to approximately 30% by weight of the recycled resin composition, and all intervals and sub-intervals in between. The upper limit of 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 intervals and sub-intervals in between.The lower limit 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 intervals and sub-intervals in between. Examples of suitable reinforcing agent components include glass fibers, ash, natural and mineral fibers, carbon fibers, ceramic fibers, and combinations thereof. Examples of natural fibers include flax fibers and kenaf fibers and fillers, which are bio-based materials. The reinforcing agent component may be present in the recycled resin composition in the form of nanofibers and / or nanoparticles. The recycled resin composition according to one or more embodiments may optionally include a melt stabilizing component. The melt stabilizing component may include chemical compounds for adjusting the viscosity of the recycled resin composition during a melting process. The melt stabilizing composition may also optionally incorporate a non-recycled resin component. Examples of a non-recycled resin component include virgin resin components, bio-based resin components, and combinations thereof. Virgin resin components are resin compositions that do not include a significant amount of recycled resin. In one or more embodiments, the virgin resin components are free of recycled resin. Virgin resin components may also include fossil fuel-based polymers or petroleum-based polymers, which may be used interchangeably, and include, without limitation, polymers formed from non-renewable sources such as fossil fuels. Such polymers include polypropylene, polyethylene not derived from sugar and other renewable resources, and polycarbonate. The term bio-based can be used interchangeably with the terms bioformed and bioderivative. A bio-based component includes components that are derived, produced, or synthesized wholly or in significant part from biological sources or renewable domestic agricultural materials (including plant, animal, and marine materials) or forest materials. For example, a bio-based component may include polymers in which the carbon is derived from a renewable resource through biological processes such as microbiological fermentation. A bio-based component may also include polymers with cellulose-based materials of varying qualities. A bio-based component may also include polymers that are substantially free of materials derived from fossil fuels or non-renewable resources, as determined by ASTM D6866-08. The bio-based component used herein includes polymers derived from biological sources, such as plants, and includes polysaccharide-derived polymers, such as starch or carbohydrate-derived polymers, and sugar-derived polymers. The starch used to form bioformed polymers can be derived from corn, potatoes, wheat, cassava, rice, and other plants. An example of a composition containing a starch-derived bioformed polymer is available from Cereplast Inc., Hawthorne, California, USA, under the trademarks and trade names Cereplast Hybrid Resins®, Bio-polyolefins®, or Biopropylene 50™. The sugar used to form such bioformed polymers can be derived from sugarcane. Such sugar-derived polymers include polyethylene, which can be produced from sugarcane-derived ethanol, which is then used to produce ethylene. Polyethylene polymers are available from Novamount SP.A., Novara, Italy, under the trademark MATER-BI®. Other examples of bioformed polymers are described in U.S. Patent No. 7,393,590, U.S. Patent Application Publications Nos. 2008 / 0113887 and 2008 / 0153940, PCT Application Publications Nos. WO07 / 099427 and WO07 / 063361, and European Patent No. 1725614, each of which is incorporated herein by reference in its entirety. A specific example of a bioformed polymer includes poly(lactic acid) or PLA, which may include a synthetic polymer produced from cane sugar or corn starch. PLA is available from NatureWorks LLC, Minnetonka, Minnesota, USA, under the trade name Ingeo™. Embodiments using PLA may also include an ethylene copolymer. Ethylene copolymers are available from EI du Pont de Nemours and Company, Wilmington, Delaware, USA, under the trade name BIOMAX®. The bio-based component includes polymers that can also be produced from microbes. Microorganisms produce substances, including polymers, by growing on raw materials, which include sugar raw materials. The production of these polymers may also involve the bacterial fermentation of sugars or lipids. Bio-based components can also be processed or synthesized from natural products. Examples of such bio-based polymers produced and / or synthesized include polyhydroxyalkanoates as defined here. The term polyhydroxyalkanoate, or PHA, includes linear polyesters produced in nature by bacterial fermentation of sugars or lipids. Examples of PHA include poly(hydroxybutyrate) and poly(hydroxyvalerate), or PHBV. PHAs may exhibit properties such as elasticity. PHAs are available from Metabolix Inc., Cambridge, Massachusetts, USA., with the trademark MIREL®. The recycled resin compositions, according to one or more embodiments, are biocompatible, as defined herein. In one or more embodiments, the recycled resin composition is capable of withstanding exposure to gamma rays, electron beams, X-rays, gaseous ethylene oxide, dry heat, plasma peroxide gas, peracetic acid, autoclave steam, and other sterilizing agents. In one or more embodiments, the recycled resin composition is radiation-stable and capable of withstanding exposure to gamma rays in the range of approximately 5 kGy to approximately 75 kGy, or more specifically, in the range of approximately 25 kGy to approximately 50 kGy.In one or more embodiments, the recycled resin composition is able to withstand exposure to electron beams in the range of approximately 30 kGy to approximately 80 kGy, or more specifically, in the range of approximately 40 kGy to approximately 70 kGy. The recycled resin composition according to one or more embodiments has a melt flow rate in the range of approximately 3 dg / minute to approximately 80 dg / minute. In one or more specific embodiments, the recycled resin composition has a melt flow rate of approximately 8 dg / minute to approximately 40 dg / minute. In even more specific embodiments, the recycled resin composition has a melt flow rate of approximately 11 dg / minute to approximately 30 dg / minute. As used herein, the term melt flow rate refers to the ease of flow of the melt of the recycled resin compositions described herein. The recycled resin compositions described herein may have a flexural modulus in the range of approximately 70 kpsi (483 MPa) to 350 kpsi (2413 MPa) and all intervals and sub-intervals therein, as measured in accordance with ASTM Standard Test Method D790. In detailed embodiments, the recycled resin composition has a flexural modulus in the range of approximately 75 kpsi (517 MPa) to approximately 300 kpsi (2068 MPa). In one or more specific embodiments, the recycled resin compositions have a flexural modulus in the range of approximately 100 kpsi (689 MPa) to approximately 300 kpsi (2068 MPa). In even more specific embodiments, the recycled resin compositions exhibit a flexural modulus in the range of approximately 130 kpsi (896 MPa) to approximately 270 kpsi (1862 MPa). zanbnn / i znz / R / v The recycled resin composition can be characterized by having an izod notch impact toughness in the range of approximately 0.1 ft-lb / in (2.9 J / m) to approximately 4.0 ft-lb / in (116.2 J / m) and all intervals and sub-intervals as measured in accordance with ASTM Standard Test Method D256. In one or more embodiments, the recycled resin composition can have an izod notch impact toughness in the range of approximately 0.2 ft-lb / in (5.81 J / m) to approximately 3.0 ft-lb / in (87.15 J / m) or in the range of approximately 0.2 ft-lb / in (5.81 J / m) to approximately 1.5 ft-lb / in (44.25 J / m). In one or more specific embodiments, the recycled resin composition has an izod notch impact toughness of approximately 0.3 ft-lb / in (8.71 J / m) to approximately 1.0 ft-lb / in (29.05 J / m).As used herein, the term izod notch impact toughness refers to the ASTM standardized method for determining impact strength. One or more embodiments of the recycled resin composition described herein may be characterized by having a heat deviation temperature in the range of approximately 60°C to approximately 260°C. As used herein, the term heat deviation temperature includes a measure of the polymer's resistance to distortion under a given load at elevated temperature. The heat deviation temperature is also known as 'deviation temperature under load' (DTUL), deviation temperature, or 'thermal distortion temperature' (HDT). The two common loads used to determine the heat deviation temperature are 0.46 MPa (66 psi) and 1.8 MPa (264 psi), although tests are occasionally performed under higher loads such as 5.0 MPa (725 psi) or 8.0 MPa (1160 psi). The common ASTM test is ASTM D648, while the analogous ISO test is ISO 75.The test using a load of 1.8 MPa according to Method A of ISO 75 was carried out concurrently with the test using a load of 0.46 MPa according to Method B of ISO 75. In one or more specific embodiments, the recycled resin composition may have a heat deviation temperature in the range of approximately 68 °C to approximately 140 °C, or in the range of approximately 68 °C to approximately 130 °C. In even more specific embodiments, the recycled resin composition may have a heat deviation temperature in the range of approximately 70 °C to approximately 95 °C. In one or more embodiments using a post-industrial recycled resin component comprising polycarbonate, the recycled resin composition has a heat deviation temperature of approximately 140 °C at a load of 0.46 MPa and 130 °C at a load of 1.8 MPa.In one or more embodiments using a post-industrial recycled resin component comprising nylon and a reinforcing agent component including glass fibers, the recycled resin composition has a heat deviation temperature of approximately 220 °C at a loading of 0.46 MPa and 200 °C at a loading of 1.8 MPa. In embodiments using a post-industrial recycled resin component comprising PET and a reinforcing agent component including glass fibers, the recycled resin composition has a heat deviation temperature of approximately 250 °C at a loading of 0.46 MPa and 230 °C at a loading of 1.8 MPa. The preparation of the recycled resin compositions of the present invention can be carried out by any suitable mixing or combining means known in the art. The mixing step should disperse the components from each other, at least minimally. The components can be mixed together in a one-step or multi-step process. In the one-step process, all components are mixed together simultaneously. In the multi-step process, two or more components are mixed together to form a first mixture, and then one or more of the remaining components are combined with the first mixture. If one or more components remain, these components can be combined in subsequent mixing steps. In one or more embodiments, all components are mixed in a single step. In one or more alternative embodiments, the recycled polypropylene composition can be prepared by dry-mixing the individual components and subsequently melt-mixing them, either directly in the extruder used to prepare the finished article or by pre-mixing them in a separate extruder. Dry blends of the composition can also be molded by direct injection without pre-mixing. The recycled resin compositions described herein are used to mold, extrude, or otherwise shape a medical device. In one or more embodiments, the medical device is disposable. For example, medical devices that can be formed from the recycled resin compositions described herein can be used in injection, infusion, blood collection, surgical applications, and other applications known in the field. Specific examples of medical devices that can be formed from the recycled resin compositions described herein include syringes (including syringe bodies, needle connector parts, plunger rods, needle shields, and the like), 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 may be molded wholly or partially from a recycled resin composition. For example, the inner surface of a syringe body may be formed from a non-recycled resin composition, while the outer surface of the syringe body or the finger flanges of the syringe body are made from a recycled resin composition. In one or more alternative embodiments, the scalpel handle or needle shield is formed from a recycled resin composition. In one or more embodiments, medical devices formed from the recycled resin compositions described herein can be characterized as medical components or devices that are not in contact with fluid pathways. Thus, the medical devices and components do not interact with or come into contact with fluids and / or solids, such as medications, drug solutions, solutions containing drugs, washing solutions, body fluids, human tissue, or any material intended to be isolated to prevent contamination. Examples of such devices include syringe plunger rods and three-piece syringes, needle guards, safety guards for injection devices, syringe body finger flanges, peripheral IV catheter loops, catheter wings, catheter flow control connectors, and so forth.Medical devices and components made from recycled resin compositions can also be classified as medical devices in contact with fluid pathways. Such medical devices or medical device components may include syringe bodies, needle connectors, surgical blade handles, valve housings, syringe retainers, and plunger rods for two-piece syringes. Non-limiting examples of medical devices are illustrated in Figs. 1 and 2. Fig. 1 illustrates the assembly of a syringe 100 comprising a syringe body 110 with an inner surface defining a chamber, a plunger rod 120 disposed inside the chamber, and a needle connector 130 comprising a needle cannula 140 for attachment to the syringe body. Fig. 1 also illustrates an optional needle shield 150 for attachment to the needle connector 130 to protect and cover the needle cannula 140. The plunger rod 120 has an elongated body 121 extending between a proximal end 122 and a distal end 123 that defines the length of the elongated body 121. The plunger rod has a thumb pusher 124 located at the proximal end 122 of the elongated body 121 and a retaining bracket 126 located at the distal end 123 of the elongated body 121.The retainer support 126 can be any structure suitable for supporting a retainer 125. The plunger rod 120 can include a separate retainer 125 attached to one end of the plunger rod 120 to form a fluid-tight seal with the inner surface of the syringe body, as shown in Fig. 1. In one or more alternative embodiments, the plunger rod 120 can include a gasket portion (not shown) that functions as a retainer and is integrally molded with the plunger rod 120 and therefore made of the same material as the plunger rod 120. The syringe body 110 shown in Fig. 1 also includes a luer-type fitting 112 at one end of the syringe body 110 and a finger flange 114 at the opposite end of the syringe body 110. In one variant, the syringe body may be formed entirely from the recycled resin compositions described herein. Alternatively, the luer fitting 112 and / or finger flanges 114 may be formed from the recycled resin compositions described herein, while the syringe body 110 is formed from known resin compositions that may include virgin resin components and / or bio-based resin components, and are free of any recycled resin.In one or more alternative configurations, the inner surface of the syringe body 110 may be coated with known resin composition(s) that may include virgin resin components and / or bio-based resin components, and are free of any recycled resin, although the remainder of the syringe body 110 is formed from one or more recycled resin compositions described herein. In one embodiment, the plunger rod 120 can be formed from the recycled resin compositions described herein. In embodiments incorporating a sealing edge (not shown) on the plunger rod 120, the sealing edge (not shown) can also be formed from the recycled resin compositions described herein. In one or more embodiments, the retainer 125 can be formed from elastomeric or other known materials, while the plunger rod is formed from the recycled resin compositions and bonded to the retainer 125. In one or more embodiments, the needle connector 130 may be formed from the recycled resin compositions described herein, while the needle cannula 140 is manufactured from materials known in the field. In one or more alternative configurations, the needle shield 150 may be formed from the recycled resin compositions described herein. Figure 2 illustrates a scalpel 200 comprising an elongated handle 210 and a blade holder 220 for attaching a blade (not shown) to the elongated handle. The scalpel 200 also includes a blade guard 230 that is detachably attached to the elongated handle 210 and / or the 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 guard 230 can be formed from the recycled resin compositions described. Figures 3A to 3E show various views of an embodiment of the invention. With respect to Figure 3A, the elongated body 121 is cylindrical and has a plurality of openings 160 through it. The plurality of openings 160 are spaced along the length of the elongated body 121. The openings reduce the weight of the plunger rod and the amount of material required to construct the plunger rod. The openings 160 can be formed by any suitable method, including, but not limited to, drilling and as part of a mold. Figure 3B shows a side view of the plunger rod of Figure 3A. Figure 3C shows a top view of the plunger rod of Figure 3A. Figures 3D and 3E show views of the proximal and distal ends, respectively. Although the plurality of 160 openings are shown as circular, experts in the field will understand that the openings can have any suitable shape.Examples of various forms are shown in the figures. None of these examples should be taken as limiting the scope of the invention. With reference to Figs. 4A-4F, some embodiments of the syringe plunger rod have an elongated body 121 comprising at least one rib 165 extending the length of the elongated body 121. At least one of the ribs 165 comprises a plurality of openings 160 separated from each other. Figs. 4A-4F show another embodiment of a syringe plunger rod having four ribs 165, two of which have a plurality of openings 160. Figs. 4A to 4E show, respectively, a perspective view, a side view, a top view, a view from the proximal end, and a view from the distal end of the plunger rod. The four ribs 165 are arranged such that the cross-section (shown in Fig. 4F) is cross-shaped.In several embodiments, all four ribs 165 have openings 160, or three ribs 165 have openings 160, or only one rib 165 has openings 160. In detailed embodiments, at least one of the ribs 165, but fewer than all of the ribs 165, has openings 160. In some embodiments, such as the one shown in FIG. 4A, the elongated body comprises at least two ribs extending its length, and the plurality of separate openings are located on fewer than all of the ribs. With respect to Fig. 4A, the elongated body has four ribs extending its length, but the openings are present only along two of the four ribs. Therefore, the openings are located on fewer than all of the ribs. The number of ribs and ribs with openings discussed here is merely illustrative and should not be considered as limiting the scope of the invention. Figure 5A shows another embodiment of a syringe plunger rod having four ribs. Two of the ribs are shown with a plurality of separate openings, but it is understood that any or all of the ribs may have openings. Figures 5A to 5E show, respectively, a perspective view, a side view, a top view, a view from the proximal end, and a view from the distal end of the plunger rod. Figure 5F shows a cross-sectional view of the ribs with the plug-like configuration illustrated. zonbnn / i znz / R / v Figure 6A shows another embodiment of a syringe plunger rod having four ribs. Two of the ribs are shown with a plurality of separate openings, but it is understood that any or all of the ribs may have openings. Figures 6A to 6E show, respectively, a perspective view, a side view, a top view, a view from the proximal end, and a view from the distal end of the plunger rod. Figure 6F shows a cross-sectional view of the ribs with the plug-like configuration illustrated. In some embodiments, the elongated body comprises three ribs. This can be seen, for example, in Figs. 7A to 7F. In Figs. 7A-7F, the plurality of separate openings is present on all the ribs. However, it is understood that the openings may be located on any of the ribs and may have any shape. In detailed embodiments, the plurality of separate openings is located along two of the three ribs. In specific embodiments, the plurality of separate openings is located on one of the three ribs. Figs. 7A to 7E show, respectively, a perspective view, a side view, a top view, a view from the proximal end, and a view from the distal end of the plunger rod. Fig. 7F shows a cross-sectional view of an elongated body with three ribs. Figures 8A to 8F show another embodiment of the invention in which a plurality of support walls 168 are spaced along the length of the elongated body 121. In the embodiment shown, the three ribs have a plurality of openings through each rib. The openings are relatively large, leaving relatively little material above the ribs. The support walls 168 can be dispersed in any of the openings to provide additional support to the plunger rod. Figures 8A to 8E show, respectively, a perspective view, a side view, a top view, a view from the proximal end, and a view from the distal end of the plunger rod. Figure 8F shows a cross-sectional view of an elongated body with three ribs and support walls. Figure 9A shows another embodiment of the invention in which the plunger rod has four ribs in a cross shape. In this embodiment, some of the ribs have different shapes, including notches. The notches can serve to reduce the amount of material used in constructing the plunger rod without significantly affecting its functionality. Figures 9A to 9E show, respectively, a perspective view, a side view, a top view, a view from the proximal end, and a view from the distal end of the plunger rod. Figure 9F shows a cross-sectional view of an elongated body with four ribs. Figure 10A shows another embodiment of the invention in which the plunger rod has three ribs. In this embodiment, some of the ribs have different shapes, including notches. Figures 10A to 10E show, respectively, a perspective view, a side view, a top view, a view from the proximal end, and a view from the distal end of the plunger rod. Figure 10F shows a cross-sectional view of an elongated body with three ribs. Figure 11A shows another embodiment of the invention in which the plunger rod has three ribs and the plurality of openings are crescent-shaped. Figures 11A to 11E show, respectively, a perspective view, a side view, a top view, a view from the proximal end, and a view from the distal end of the plunger rod. Figure 11F shows a cross-sectional view of an elongated body with three ribs. Figure 12A shows another embodiment of the invention in which the plunger rod has two V-shaped ribs. To reinforce this configuration, it may be useful to include a plurality of separate support walls along the length of the elongated body. Figures 12A to 12E show, respectively, a perspective view, a side view, a top view, a view from the proximal end, and a view from the distal end of the plunger rod. Figure 12F shows a cross-sectional view of the elongated body with two ribs and support walls. Figure 13A shows another embodiment of the invention in which the plunger rod has four cross-shaped ribs with two additional ribs along an elongated axis, one above the main cross rib and one below the main cross rib. Figures 13A to 13E show, respectively, a perspective view, a side view, a top view, a view from the proximal end, and a view from the distal end of the plunger rod. Figure 12F shows a cross-sectional view of the elongated body showing the four main cross-shaped ribs with the two additional ribs shown above and below the main horizontal cross rib. Figure 14A shows another embodiment of the invention in which the plunger rod has an elongated hollow cylindrical shape with a hollow portion inside and a thumb pusher at the proximal end. The thumb pusher may have an opening aligned with the elongated hollow shape or may be solid, closing the hollow portion of the elongated cylindrical body. The elongated hollow cylindrical shape may be open at one end, closed at one end (either proximal or distal), or closed at both ends. The closures may be integrally formed or may be a separate piece attached to the hollow cylinder. The walls of the elongated hollow cylindrical body may have a suitable thickness, providing sufficient mechanical strength to withstand the thrust of the plunger rod through the syringe body. A thicker wall will have greater mechanical strength but will require additional material for its manufacture.Figures 14A to 14E show, respectively, a perspective view, a side view, a top view, a view from the proximal end, and a view from the distal end of the plunger rod. Figure 14F shows a cross-sectional view of an elongated hollow cylindrical body. The shape of the elongated hollow cylindrical body and the hollow portion can vary. In specific embodiments, the shape of the hollow portion is similar to that of the elongated body. For example, the elongated body may be rounded, and the hollow portion may be rounded to match the shape of the elongated body. In several embodiments, the elongated body is square, rectangular, or octagonal, and the hollow portion is square, rectangular, or octagonal, respectively. Additionally, the shape of the hollow portion may be different from that of the elongated body. For example, a square elongated body may have a round hollow portion that extends along the length of the elongated body. Figure 15A shows another embodiment of the invention in which the plunger rod has a hollow shape similar to that of Figure 14A. In Figures 15A to 15F, the hollow plunger rod has a combination of ribs zonbnn / i znz / R / v extending axially along the length of the hollow cylindrical body. The ribs are shown in a cross-shaped configuration. The ribs may extend the entire length of the body or may be along a partial length. In the embodiment shown, the ribs extend from the retaining end of the plunger rod to a point approximately two-thirds of the way along the plunger rod. At this point, the ribs taper inward toward the hollow plunger rod. Those knowledgeable in the field will understand that this is merely illustrative of a specific embodiment and that the length of the ribs along the plunger rod may vary.Additionally, the ends of the ribs can be blunt or tapered as shown. The taper can be any shape and length as desired. Figures 16A to 16F show a similar configuration with three ribs extending along the length of the hollow cylindrical body. Figures 17A to 17F show a similar configuration in which the elongated body is square. Figures 18A to 18F show a similar configuration in which the elongated body is an elongated octagon. Those skilled in the art will understand that the cross-sectional shape of the elongated hollow body can be any suitable shape, including, but not limited to, triangle, pentagon, hexagon, heptagon, nonagon, and decagon. Figures 19 to 29 show various embodiments of the invention. The piston rods may be cylindrical or made of a plurality of ribs and may have support walls. The embodiments shown are merely illustrative and should not be taken as limiting the scope of the invention. Figure 22A shows an elongated body with a hollow portion, the hollow portion being enclosed within the elongated body. This is best shown in the cross-section of Figure 22B. Here, the hollow portion is completely contained within the elongated body, but it is understood that the hollow portion may extend to one or both ends of the elongated body. Figure 23A shows a detailed embodiment of the invention in which three main ribs extend the length of the elongated body. With respect to Figures 23A to 23F, a plurality of separate openings extend along one of the three ribs. Additionally, a plurality of support walls are adjacent to the plurality of openings along the length of the elongated body. This provides material savings in space and additional structural support with the support walls. Figure 23B shows a top (or bottom) view of the plunger rod in Figure 23A. Figure 23C shows a left (or right) view of the plunger rod in Figure 23A. Figures 23D and 23E show top-to-bottom views of the thumb pusher and the retainer support, respectively. The cross-section shown in Fig. 23F illustrates the shape of the support walls. Further embodiments of the invention relate to syringe plunger rods comprising an elongated body having at least one opening through it. The at least one opening may be along the length of the body such that the opening extends perpendicularly to the elongated axis, as shown in Fig. 5A. The at least one opening extends along the length of the elongated body, as shown in Fig. 14A. In some embodiments, there is a combination of openings that extend along and are perpendicular to the elongated axis. The syringe plunger rod may be prepared from a composition comprising one or more of a virgin material, a sterilization-stable recycled resin, and a bio-based composition. In one or more embodiments, medical devices formed from the recycled resin compositions described herein do not change color after sterilization, as measured by the yellowing index. For example, the medical devices can be sterilized as described above without undergoing any change in color or appearance. Medical devices can be manufactured using various known methods. These methods include injection molding, blow molding, extrusion, and / or rotational molding. Other known methods may also be used to manufacture medical devices or components. Medical devices formed from the described recycled resin composition may include a plunger rod that exhibits acceptable functional behavior to users and / or physicians. In one or more embodiments, a plunger rod formed from the recycled resin compositions described above exhibits the same functional behavior as plunger rods formed from non-recycled resin compositions or compositions that do not include any recycled content. A third aspect of the present invention pertains to a method for forming medical devices and components. In one or more embodiments, the method includes providing a melt-mix composition of the recycled resin compositions described herein. The method includes stabilizing the melt-mix composition and solidifying the composition into a preselected shape, which may include a plunger rod, syringe body, catheter, blood collection device, surgical blade handle, needle shield, and needle connector. In one or more embodiments, stabilizing the melt-mix composition includes stabilizing it to withstand exposure to gamma rays, electron beams, X-ray radiation, and gaseous ethylene oxide without adversely affecting its functional performance and the aesthetic appeal of the finished product. According to one embodiment, the step of providing a melt blend composition comprises feeding a recycled resin component and one or more of the following: an antioxidant component, a slip additive component, an antistatic component, an impact modifier component, a colorant component, an acid sequestrant component, a melt blending component, a clarifying component, an x-ray fluorescence agent component, a radiopaque filler component, a surface modifier component, a processing aid component, and a reinforcing agent component into an extruder for melt compounding. The step of solidifying the composition comprises injection molding the composition, extruding the composition, and rotational molding the composition. Recycled resin compositions, medical devices and components made from such compositions, and methods of preparing such medical devices and components provide a unique system in the supply chain that reduces the impact on landfills. The present invention shall be further understood by reference to the following non-limiting examples; however, the scope of the claims is not limited thereby. zonbnn / i znz / R / v EXAMPLES Inventive formulations 1-6 were prepared by mechanically mixing recycled polypropylene resins with virgin polypropylene resins, wherein the virgin polypropylene resins further comprise antioxidants, acid sequestrants, and melt stabilizers. Inventive Formulation 1 included 60% by weight of recycled polypropylene component A and 40% by weight of virgin polypropylene component A. The virgin polypropylene component A included up to 0.8% by weight of an antioxidant component and a melt stabilizer component and up to 0.3% by weight of an acid sequestrant component. Inventive Formulation 2 included 70% by weight of component B of recycled polypropylene and 30% by weight of component A of virgin polypropylene, as described above. Inventive Formulation 3 included 50% by weight of component C of recycled polypropylene and 50% by weight of component A of virgin polypropylene, as described above. Inventive Formulation 4 included 60% by weight of recycled polypropylene component A and 40% by weight of virgin polypropylene component B. Virgin polypropylene component B included up to 0.3% by weight of an antioxidant component and up to 0.2% by weight of an acid sequestrant component. Inventive Formulation 5 included 50% by weight of component B of recycled polypropylene and 50% of component B of virgin polypropylene, as described above. Inventive Formulation 6 included 60% by weight of component D of recycled polypropylene and 40% by weight of component A of virgin polypropylene, as described above. The physical properties of each of the Inventive Formulations 1-6 were analyzed. Specifically, the flexural modulus, tensile yield strength, tensile rupture, tensile elongation limit, tensile elongation rupture, tensile modulus, Izod impact toughness, and temperature deviation of the Inventive Formulations 1-6 provided below in Table 1 were evaluated. For comparison, typical ranges for the physical properties of virgin polypropylene components are provided in Table 2. The flexural modulus was measured in accordance with ASTM D790-03. Tests were performed on five specimens of each of Inventive Formulations 1-6. The tests were conducted using a head speed of 0.05 in / min (0.127 cm / min) and a support expansion length of 2 in (5.08 cm) on an instrument provided by Instru-Met Corp., of Rahway, New Jersey, USA. The specimens were formed using an injection molding procedure and conditioned at 23°C and 50% relative humidity (RH) prior to testing. The average flexural modulus measurement for each of the five specimens for the Inventive Formulations is provided in Table 1. The tensile properties of Inventive Formulations 1-6 were evaluated in accordance with ASTM D638-03. Tests were performed on five specimens of each of Inventive Formulations 1-6. The tests were conducted using a head speed of 2 in. / min (5.08 cm / min) on an instrument provided by Instru-Met Corp., of Rahway, New Jersey, USA. Type I zanbnn / i znz / R / v tensile bar specimens were formed using an injection molding procedure and conditioned at 23°C and 50% RH for 40 hours prior to testing. The average tensile yield strength, tensile rupture, tensile elongation limit, tensile elongation rupture, and tensile modulus measurements for each of the five specimens for Inventive Formulations are provided in Table 1. The Izod impact strengths of Inventive Formulations 1-6 were evaluated according to ASTM D256-02. Tests were performed on ten specimens of each of Inventive Formulations 1-6. The average Izod impact measurements for Inventive Formulations 1-6 are provided in Table 1. The thermal deviation temperatures of Inventive Formulations 1-6 were evaluated in accordance with ASTM D648-06 using an HDTA / icat instrument available from Tinius Olsen, Inc. of Horsham, Pennsylvania, USA, at a load of 66 psi (455 kPa). Average Izod impact measurements for Inventive Formulations 1-6 are provided in Table 1. zonbnn / i znz / R / v Table 1: Physical properties of inventive formulations 1-6. Inventive Formulation 1 2 3 4 5 6 Flexural Modulus (psi) (kPa) Average 174345 (1,201,237) 148373 (1,022,290) 207247 (1,427,932) 187735 (1,293,494) 159857 (1,101,415) 157830 (1,087,449) Standard Deviation 2153 1288 4749 4200 2629 1385 Tensile Yield Strength (psi) (kPa) Average 4694 (32,342) 4372 (30,123) 4959 (34,168) 4919 (33,892) 4737 (32.638) 4408 (30.371) Standard deviation 77 74 100 42 41 56 Tensile strength (psi) (kPa) Average 2228 (15.350) 2665 (18.361) 4044 (27.863) 4058 (27960) 2740 (18.878) 2798 (19278) Standard deviation 304 81 779 162 81 84 Tensile elongation limit (%) Average 9.67 11.1 8.37 7.87 9.27 8.41 Standard deviation 0.750 0.558 0.255 0.515 0.436 0.939 Break at the tensile elongation (%) Average 116 254 24.8 23.2 165 241 Inventive Formulation 1 2 3 4 5 6 Standard Deviation 141 121 15.3 3.50 40.5 62.3 Tensile Modulus (psi) (kPa) Average 238539 205376 264521 251694 234553 234458 Standard Deviation 7031 11233 6799 9940 11561 2841 Izod Impact Strength (t-lbs / in) (J / m) Average 0.46 (13.36) 0.51 (14.81) 0.53 (15.39) 0.53 (15.39) 0.44 (12.78) 0.51 (14.81) Temperature Deviation (°C) Average 84.6 77.8 109.3 92.2 96.1 104.9 zonbnn / i znz / R / v Table 2: Typical physical properties of virgin polyolefin resins. Physical Properties Flexural Modulus 145037.7 psi (1000 MPa) - 290075.4 psi (2000 MPa) Tensile Yield Strength 3625.9 psi (25 MPa) - 6526.7 psi (45 MPa) Tensile Elongation Limit 6%-15% Tensile Modulus 145037.7 psi (1000 MPa) - 261067.9 psi (1800 MPa) Notch Impact Toughness izod 0.3 ft-lb / in (8.85 J / m)-1.0 ft-lb / in (29.05 J / m) Heat Deflection Temperature 70°C-110°C The physical properties of Inventive Formulations 1-6 are comparable to the physical properties of virgin polyolefin resins, as shown in Table 2. Accordingly, the recycled resin compositions described herein achieve the goals of using recycled resins that are biocompatible and useful for medical device applications, without compromising the physical properties of the resulting devices. Inventive Formulations 1-6 were also analyzed to establish their biocompatibility. Specifically, each of Inventive Formulations 1-6 was analyzed according to ANSI / AAMI / ISO 10-993-5 standards and the United States Pharmacopeia biological tests and assays, Biological Reactivity Tests, in Vitro <87> The United States Pharmacopeia in vitro biological reactivity assays <87> These tests are designed to determine the biological reactivity of mammalian cell cultures after contact with elastomeric plastics and other polymeric materials, whether through direct or indirect patient contact, or with specific extracts prepared from the materials under test. The elution assay described in the United States Pharmacopeia in vitro biological reactivity assays was performed. <87> , on Inventive Formulations 1-6. Each of Inventive Formulations 1-6 passed or met the United States Pharmacopeia cytotoxicity assay standards with a score of zero, thus meeting the criteria for preclinical evaluation of toxicological safety established by the United States Pharmacopeia and ISO 10-993-5. All biocompatibility assays were performed in accordance with the principles of good laboratory practice or GLP following known procedures in the field. References throughout this specification to an embodiment, certain embodiments, one or more embodiments, or an embodiment mean that a particular feature, structure, material, or characteristic described in conjunction with the embodiment is included in at least one embodiment of the invention. Thus, the phrases "in one or more embodiments," "in certain embodiments," "in an embodiment," or "in several embodiments" appearing in various places throughout this specification do not necessarily refer to the same embodiment of the invention. Furthermore, the specific features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments. Although the invention described herein has been illustrated with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It will be evident to those skilled in the art that various modifications and variations of the method and equipment of the present invention may be made without departing from the spirit and scope of the invention. Accordingly, the present invention is intended to include modifications and variations that are included within the scope of the appended claims and their equivalents.
Claims
1. A syringe plunger rod comprising: an elongated body having a proximal end and a distal end defining a length, the elongated body having an elongated cylindrical hollow shape with a hollow portion therein extending along the length; a thumb pusher positioned at the proximal end of the elongated body;and a retaining bracket positioned at the distal end of the elongated body, wherein each of the elongated body and the retaining bracket comprises compositions comprising a mixture of 50% to 70% by weight of a recycled resin and 30% to 50% by weight of a virgin resin, wherein the recycled resin component is selected from a combination of post-industrial recycled resin and post-consumer recycled resin, wherein the compositions pass or meet a score of zero for cytotoxicity of the United States Pharmacopeia, wherein the recycled resin is recycled polypropylene and the virgin resin is virgin polypropylene, and wherein the plurality of spaced openings occurs at an intersection of at least two of the ribs.
2. The syringe plunger rod of claim 1, further comprising at least one rib within the hollow portion extending at least partially along the length of the elongated body.
3. The syringe plunger rod of claim 1, wherein the hollow portion is configured substantially similarly to the elongated body.
4. The syringe plunger rod of claim 1, wherein the hollow portion is configured differently from the elongated body.
5. The syringe plunger rod of claim 1, wherein the at least one rib extends the entire length of the elongated body and tapers into the interior of the hollow portion of the plunger rod. zonbnn / i znz / R / v