The present invention generally relates to disposable items made from flexible bioplastic resins.
Environment and sustainability have become increasingly important factors in the design and specification of medical and printing articles across the world. In hospitals, pharmaceuticals, life sciences, and healthcare industries, safe disposal of articles after use is an important issue. Special considerations are given to selecting materials in the final design for disposable articles, so as to reduce the quantity of syringes items that enter waste streams. These facilities and industries must initiate environmentally safe disposal methods because they generate a large amount of the bio waste. Due to higher social responsibility and environmental concerns, corporations are being driven to produce more sustainable and environmentally safe products through government regulations, by institutional investors, and through consumer demand.
Polylactic acid (PLA) is a transparent bioplastic produced from corn, beet and cane sugar. It not only resembles conventional petrochemical mass plastics, such as polyethylene (PE), polyethylene terephthalate (PET or PETE), and polypropylene (PP) in its characteristics, but it can also be processed easily on standard equipment that already exists for the production of conventional plastics. PLA has a density of 1.25 to 3 g cm, which lower than PET, and PLA has a refractive index of 1.35-1.45, which is lower than PET, which has a refractive index of 1.54. PLA is currently used in biomedical applications, such as sutures, stents, dialysis media and drug delivery devices. It is also being evaluated as a material for tissue engineering.
Bioplastic resins include Polylactic acid (PLA), cellulose based PH, polybutylene adipate terephthalate (PBT) and polycaprolate (PCL), from corn and cellulose; green polyethylene, (GPE) and green polyethylene terephthalate (GPET also known as GPETE) from sugarcane; and Poly3-hydoxybutrate-3-hydroxyhexxanate (PHBH) from a fermentation process using glucose and propionic acid as the carbon source for Alcaligenes eutrophus. PHA polyhydroxyalkanoate) is derived by plant fermentation. Poly L lactide (PLLA) and poly D lactide (PDLA) are forms or homo-polymers of PLA. PLA, PDLA, and PLLA are especially compostable and can be degraded to make eco-friendly compost or humus. Bioplastic resins include PLA, PHA, PCL, PH, PBT, GPE, GPET, PHBH, PDLA, and PLLA.
Acetyl tributyl citrate (herein referred to as “ATBC”) is a transparent biodegradable plasticizer having low toxicity. It is also referred to as tributyl acetyl citrate, butyl acetylcitratem, O-acetylcitric acid tributyl ester, ATCB, or acetyl tributylcitrate. It has molecular formula C20H3408.
Bioplastic resins have some distinct advantages over plastic and glass. Bioplastic has a much smaller carbon footprint compared to plastic or glass, and also uses less energy to form an article like a syringe. Bioplastic is biodegradable in an industrial composting unit. Bioplastic resins are from a plant source, and when plants are grown, they absorb carbon dioxide, thus decreasing carbon dioxide in the atmosphere. Plastic and glass disposable items have a higher carbon footprint than bioplastic items.
Currently syringes, when they are disposed of and enter the waste stream, are considered a bio waste. They have to be disposed off in a safe method and may go through incineration. This process is detrimental to the environment in that it causes release of hydrocarbons and toxins into the atmosphere and creates fly ash that ends up in landfills. Bioplastic articles can be sterilized, shredded and composted, thereby bypass this process. Bioplastic articles are environmentally safe and sustainable, when compared to plastic or glass, leading to near-zero waste.
Bioplastic, however, has poor permeability characteristics, in reference to water, oxygen and carbon dioxide. Bioplastic also has poor flexibility properties and is rigid. PLA, a bioplastic, has poor thermal properties, with heat distortion threshold of 55 Celsius, compared to plastics.
It would be desirable to provide disposable items made from flexible bioplastic resins.
In one aspect of the present invention, a method includes providing a bioplastic resin, and mixing the bioplastic resin with a biodegradable plasticizer that includes acetyl tributyl citrate (ATBC); thereby providing a flexible biodegradable material.
In another aspect of the present invention, a flexible biodegradable material includes a bioplastic resin and acetyl tributyl citrate (ATBC).
The preferred embodiment and other embodiments, which can be used in industry and include the best mode now known of carrying out the invention, are hereby described in detail with reference to the drawings. Further embodiments, features and advantages will become apparent from the ensuing description, or may be learned without undue experimentation. The figures are not necessarily drawn to scale, except where otherwise indicated. The following description of embodiments, even if phrased in terms of “the invention” or what the embodiment “is,” is not to be taken in a limiting sense, but describes the manner and process of making and using the invention. The coverage of this patent will be described in the claims. The order in which steps are listed in the claims does not necessarily indicate that the steps must be performed in that order.
In an embodiment, PLA or heat stable PLA, namely PLLA , PDLA and additives like ATBC are first subject to trace element extraction, to achieve medical grade resin and additives. To this medical grade PLA is added medical grade ATBC in a ratio from 5 to 35% ATBC by weight and mixed in a mixer for 10 minutes. This final medical grade resin granules are then bagged and a batch and a traceable code are printed on each bag and detailed log is kept. This medical grade mix is then used to make medical items like syringes and with a tubular needle cap and a flexible foldable needle safety shield . This mixture is not only limited to such items and can include other medical and non medical items. For the non medical items the PLA and ATBC mix does not have to me medical grade. Both medical and non medical items can be injection or blow molded . Examples include bottles, containers, sharps containers, syringes, test tubes, catheters, IV bags, urinal, prescription bottles, etc.
In an embodiment, plasticizers or additives or both may be added to PLA. ATBC can be added to improve flexibility. To overcome distortion, heat tolerant PLA may be used, such as PLLA and PDLA, to offer higher heat distortion properties. If to be used in the human body, all these materials will be of medical grade to meet FDA approval and standards.
A flexible, biodegradable material may be substantially free of non-biodegradable elements, in that the material will include the bioplastic resin and the ATBC, but will not intentionally or knowingly include additives that are not biodegradable.
An embodiment may include a PLA and ATBC mixture at a ratio of 5 to 35% weight, which produces a bioplastic resin that is flexible and not rigid. The tensile strength of PLA is 36.4 MPa and may be improved to 13.1 MPa, and elongation at break may improve from 7.2% of PLA to 483.5% for the bioplastic mixture. This makes the mixture more flexible. Embodiments of this flexible grade PLA mixture may be injection, blow molded thermoformed, or otherwise molded in many items and articles in daily life that need flexibility or are squeezed, such as shampoo bottles and medicine ointment bottles. Embodiments may be used in daily consumer products that are for either medical or nonmedical use, namely, but not limited to bottles, containers, specimen jars, syringes, scalpels, lancets, urinals , pharmacy prescription bottles, catheters, test tubes, intravenous (IV) lines , IV and blood transfusion bags, ink cartridges and laboratory items and other disposable single use items . The items may be “disposable” because they are biodegradable or at least degradable.
Embodiments of the present invention may provide disposable syringe with a tubular needle cap and a flexible foldable needle safety shield, made from sustainable and environmentally safe bioplastic resins. Embodiments may be made from bioplastic resins, namely, polylactic acid (PLA), polyhydroxyalkonate (PHA), poly 3 hydroxybutrate co 3 hydroxyhexanote (PHBH), and biopolymer poly-3-hydroxybutyrate (PHB), and may have a UV-cured coating.
Embodiments may be made of a flexible bioplastic material that includes polylactic acid (PLA) and acetyl tributyl citrate (ATBC).
Disposable pipettes and pipette tips are an instrument used to transport a measured volume of liquid, and may commonly be used in medical, pharmaceutical , microbiology and chemistry labs. A disposable pipette is made of plastic and consists of a hollow, a bulb section at one end with a hollow tubular section. The hollow tubular section at the opposite end may have a tapered open mouth. The bulb section is used for handling the pipette, and may be generally rigid, but compressible when squeezed. A pipette tip consist of an open hollow tubular section with a tapered narrow end at the opposite end.
A vaginal speculum is a diagnostic instrument for dilating the opening of the vaginal cavity in order that the interior may be more easily visible for observation. Embodiments of vaginal speculum include the bivalve vaginal speculum; the two blades, an upper and a lower, are hinged and are “closed” when the speculum is inserted to facilitate its entry and “opened” in its final position. A vaginal speculum may have a third part, the forked connector portion, and the set of blade pairs attached to the distal end of the forked connector. Both pairs of the blades may have snapping engagement with the handle on the locking mechanism. The blades distal ends may be connected to the forked connector. The whole speculum may be disposable after single use. The lower blade acts as part of the handle and may house a portable or rechargeable light or illumination device. The illumination device can be mounted on either blade and may not be portable and connect to wall unit for power. The speculum may vary in size from small (W ⅞×L 4 inches), medium (W 1⅛×L 4 inches) to large (W 1⅜×L 4½ Inches).
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An embodiment of a device for storing medicine may include a container and a safety cap. An embodiment of a safety cap may include a circumferential outer skirt and a circumferential, resilient, inner member. An embodiment of a container may have a rigid wall having an end for engagement with the cap internally of the cap's outer skirt, along a closure plane. The wall of the container may engage internally with the resilient inner member of the cap and expand the resilient inner member outwardly to provide a working seal of the container. The container and the safety cap may be bioplastic resin, and the resilient inner member may be bioplastic resin or another biodegradable, resilient material that could be used as a gasket to store medicine.
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A specimen container is commonly used to collect urine, faces, human body tissue or biopsy tissue. A human biological specimen container is very specific and will usually vary in size from 2 to 4 oz. The lateral wall has a graduated marking in ounces or milliliters ranging from 0-4 oz., or 0 to 120 ml. An embodiment may have the shape depicted in the figures. The container can be non-sterile or sterile and individually packed in a sterile pouch. The specimen container can be empty or can have a reagent like formaldehyde.
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Embodiments of a medicine dispensing cup may be intended to be used for portioning medicine in a solid or liquid state, usually one to two fluid ounces or one or several tablets or capsules. The medicine cup may be made from paper or plastic namely polypropylene. The medicine dispensing cup may include a wall having a cross section which conically decreases from a top open edge towards a closed bottom edge. The top edge forms an open aperture, and has a wall integral with the top edge. The wall may have a cross section that conically decreases from said top edge towards said closed bottom, until the wall merges into a closed bottom. The space from said open top to the closed bottom is a distance that may be at least one-half the total distance between said top edge and bottom. The cup may be or not marked on the lateral wall with graduated marking in millimeters, ounce or drams. Example cups may vary in size from one ounce to eight ounces. Embodiments may include a lid to cover the open aperture. The lid shape is related to the conical angle of said outer top open aperture wall of the cup. In embodiments, the medicine cup may made from bio resins such as PLA (PLLA and PDLA).
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A urinal is commonly used in health care facilities to safely collect, temporarily store and dispose urine form patients. This type of urinals are in widespread use and are manufactured by blow-molding from a suitable polymer, such as polyethylene, so as to have a body having a lower wall, an upper mouth, and front, side, and back walls and so as to have a unitary handle projecting from the body, near the upper mouth, toward a lower portion of the front wall, whereby a gap is defined between the handle and an upper portion of the front wall. Commonly, a urinal of the type noted below is provided with a cap, which is adapted to be snap-fitted around a margin of the upper mouth and which is attached to the handle, where the handle meets the body, via a tether that is unitary with the cap. The urinal may be or not marked on the lateral wall with graduated marking in millimeters or ounce. The size and shape of the urinal can vary. In this embodiment the urinal is made from bio resins, namely PLA (PLLA and PDLA).
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Identification bands for patients (IBP), are generally made from vinyl or other plastic material. These IBP may be formed in sheets with adjacent IBP being flipped end-to-end to allow them to nest and thereby save on wasted material. The snap closures are also generally made of plastic and are mounted in a “toe” vinyl extension from the panel side opposite the strap. This toe extension generally comprises a tab portion aligned with and opposite to the strap and within which the snap closure is located. The snap closure includes a pin centered along the same center axis as the strap, which centers the snap closure to the panel and strap holes so that when the IBP is applied by attaching the strap to the snap closure the strap remains aligned with the panel. The IBP can be applied using a thermal adhesive closure. Typical size for adult IBP is 11 inches×1¾ inches, and infant or child IBP is 8×¾ inches. The size, shape and color can vary. On the tail or patient information area, a printed bar code and or serialized alphanumeric codes can be printed or paper label applied. This ensures maximum safety and provides scan ability.
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Disposable items made from bioplastic resins include a biodegradable resin and a plasticizer. The resin and plasticizer are intermixed to provide a bioplastic. A disposable device may include a syringe, a multidose syringe, a needle cap and needle safety shield, a specimen tube, a scalpel, a lancet, a sharps container, a suction canister, an ink cartridge, or a toner cartridge. The bioplastic may include Polylactic Acid (PLA) or Polyhydroxyalkonoate (PHA). A method of disposing of an item includes providing a bioplastic, the item including or made of the bioplastic; sterilizing the item utilizing steam, radiation, or ethylene oxide gas; shredding the item; and composting the item into a compost end product, thereby disposing of the item.
This application claims the benefit of the filing date of U.S. patent application Ser. No. 14/553,437, filed Nov. 25, 2014, (PA010-107C), which is incorporated herein by reference in its entirety, and U.S. patent application Ser. No. 14/553,479, filed Nov. 25, 2014, (PA010-107E), which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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Parent | 14553437 | Nov 2014 | US |
Child | 14948335 | US | |
Parent | 14553479 | Nov 2014 | US |
Child | 14553437 | US |