Low Cyclic Silicone for Medical Packaging Applications
24 patents in this list
Updated:
Medical-grade silicone packaging materials must maintain sterility while meeting strict regulatory requirements for extractables and leachables. Current formulations show extractable turbidity levels above 0.3 NTU and can release unwanted residual compounds during sterilization processes at temperatures reaching 150-190°C.
The fundamental challenge lies in developing silicone compositions that combine low extractables with the mechanical properties needed for medical packaging—particularly elongation, tear strength, and dimensional stability through sterilization cycles.
This page brings together solutions from recent research—including modified crosslinking systems, optimized vinyl-terminated polymers, specialized filler technologies, and surface treatment approaches. These and other developments focus on achieving medical-grade performance while meeting increasingly stringent regulatory requirements for extractables and biocompatibility.
1. 3D Printing Method for Mold-Free Fabrication of Customized Silicone Biomedical Devices
SHANGHAI CANGXUN INTELLIGENT TECH CO LTD, SHANGHAI CANGXUN INTELLIGENT TECHNOLOGY CO LTD, 2024
Biomedical silicone products, a mold-free preparation method, and applications for customized medical devices. The method involves using 3D printing to create personalized biomedical devices made of silicone. The process involves mixing silicone precursor materials like polyethylene glycol monomethacrylate and hydrogen-containing silicone oil with a catalyst and initiator. The mixture is then 3D printed layer by layer without using molds. The printed silicone parts are cured to form the final customized devices. This allows precise shaping and customization of silicone devices without the cost and complexity of injection molding. The silicone 3D printing process involves optimizing parameters like layer thickness, cure time, and material composition to achieve good mechanical properties and dimensional accuracy in the printed devices.
2. Silicone Rubber Leather with Crosslinked Vinyl Silicone and Nano-Titanium Dioxide for Enhanced UV and Alcohol Resistance
广东天跃新材料股份有限公司, GUANGDONG TIANYUE NEW MATERIALS CO LTD, 2023
Medical grade silicone rubber leather material with improved resistance to alcohol wiping and UV yellowing. The leather is made by crosslinking vinyl silicone rubber with hydrogen-containing silicone oil, platinum catalyst, and ethynyl cyclohexanol. Modified nano-titanium dioxide is added to the silicone rubber to absorb and scatter UV light. This reduces UV penetration and yellowing. The leather has a base fabric layer and a silicone rubber layer made by this compound. It provides better alcohol resistance and UV stability compared to conventional silicone or polyurethane leathers.
3. Crosslinked Silicone Compositions with Alkoxysilane Additive and Post-Crosslinking Water Immersion Treatment
WACKER CHEMIE AG, 2022
Crosslinked silicone compositions with low surface friction suitable for medical devices like catheters and syringes. The compositions are made by a process that involves crosslinking a specific silicone elastomer composition containing an alkoxysilane additive. After crosslinking, the material is allowed to rest for at least 30 minutes, then immersed in water for at least 30 minutes. This treatment reduces the surface friction compared to unmodified crosslinked silicone. The process steps of crosslinking, resting, and immersion are critical for achieving low friction properties.
4. Curable Liquid Silicone Rubber Composition with Reactive Terminal Groups and Fillers
ELKENN SILICONE CO, ELKINE SILICONE GERMAN CO LTD, 2022
Curable liquid silicone rubber composition for drug delivery devices that improves active ingredient efficacy. The composition contains reactive groups like terminal alkenes, fluorides, or seleniums in the silicone chains. This allows better release of drugs like progestogens from the silicone elastomer after curing. The composition also has fillers like silica and resins. It cures at temperatures up to 220°C. The resulting molded silicone rubber is used as a drug delivery device like an intravaginal ring.
5. Organic Silicon Material with Enhanced Wear Resistance and Specific Composition for Medical Devices
CHANGZHOU NUOPOO NEW MAT CO LTD, CHANGZHOU NUOPOO NEW MATERIAL CO LTD, 2021
Wear-resistant and long-life organic silicon material for medical devices that can address the shortcomings of current silicone medical products in terms of wear resistance and mass production. The material is made by combining specific amounts of silicone rubber, organosiloxane, fillers, molding aids, reinforcing aids, and crosslinking aids. The optimized composition enables improved wear resistance for medical devices like tubing compared to standard silicone rubber. The material can be prepared by mixing and molding the components.
6. Medical Silicone Rubber Composition with Polyurethane and Method of Preparation
山东百多安医疗器械股份有限公司, SHANDONG BRANDEN MEDICAL DEVICES CO LTD, 2021
Medical silicone rubber with high mechanical properties and a preparation method. The medical silicone rubber composition contains silicone rubber, polyurethane, filler, hydrogen-containing silicone oil, and a vulcanizing agent. The rubber is prepared by mixing the silicone rubber and polyurethane in an internal mixer, then adding the hydrogen-containing silicone oil, silicone rubber, and vulcanizing agent in small batches to the open rubber mixer, and finally vulcanizing the mixture at 150-190°C for 5-5 minutes.
7. Silicone Admixture with Silicone Hyperpolymer and Silica Reinforcer for Medical Device Fabrication
株式会社名南ゴム工業所, 株式会社SMPテクノロジーズ, 2019
A silicone admixture for making medical devices with improved skin compatibility. The admixture contains a miraculous silicone rubber, a silicone hyperpolymer, a vulcanizing agent, and silica reinforcer. The silicone high polymer provides hardness and the miraculous silicone rubber provides softness. The cured product has a loss tangent (Tan δ) of 0.3-0.6 at 0-50°C, providing a comfortable fit against skin. The reinforcer prevents dilution of the rubber components. This admixture can be used to make medical devices that touch the skin, like catheters, tubes, and implants, to improve their comfort and biocompatibility.
8. Solid Silicone Rubber Composition with Specific Methyl Vinyl Silicone Ratios and Polyvinyl Silicone Resin
华南协同创新研究院, 2019
Highly transparent and highly elastic solid silicone rubber material. The rubber contains specific ratios of methyl vinyl silicone rubbers with different molecular weights and vinyl contents, along with a small amount of polyvinyl silicone resin. The exact ratios are provided in the examples. The rubber has high visible light transmittance and elasticity due to the specific silicone rubber compositions.
9. Manufacturing Method for Soft Silicone Contact Lenses Using Polydiorganosiloxane Composition with Acryloyl and Thiol Functional Groups
ALCON INC, 2019
Method to manufacture soft silicone contact lenses with consistent mechanical properties for improved oxygen permeability and comfort. The method involves using a specific composition of silicone polymers to create the contact lens material. The composition includes a blend of polydiorganosiloxanes with acryloyl and thiol groups. This allows curing the silicone to the desired elasticity and breaking elongation while maintaining oxygen permeability. The acryloyl groups crosslink the silicone and the thiol groups act as chain extenders. The resulting crosslinked silicone has lower modulus (stiffness) and higher elongation at break compared to conventional silicone.
10. Silicone Article Comprising Vinyl-Terminated Polymer and Fumed Silica Filler with Controlled Turbidity Levels
SAINT-GOBAIN PERFORMANCE PLASTICS CORP, 2015
Silicone article with low extractable turbidity levels suitable for medical applications. The article is made from a silicone composition containing a silicone matrix, fumed silica filler, and a vinyl-terminated silicone polymer with a viscosity of 500-5000 cP. This composition allows forming silicone articles like tubes with turbidity below 0.3 NTU. The low turbidity is achieved by using the specific vinyl-terminated silicone polymer with optimized viscosity.
11. Radiation-Stable Silicone Rubber Composition with Dispersed Antioxidant and Polydimethylsiloxane
TERUMO KABUSHIKI KAISHA, 2013
Silicone rubber composition for medical devices that can be sterilized by radiation without hardening. The composition contains an antioxidant dispersed in the silicone rubber, along with polydimethylsiloxane. The antioxidant and PDMS prevent radical crosslinking during radiation sterilization, limiting hardening of the silicone rubber.
12. Silicone Formulations with Polar Radiation Resistant Component for Gamma Irradiation Sterilization
SAINT-GOBAIN PERFORMANCE PLASTICS CORP, 2012
Radiation resistant silicone formulations for medical devices that can be sterilized using gamma irradiation without adversely affecting device performance. The formulations contain a small amount (0.1-20 wt%) of a polar radiation resistant component in the non-polar silicone matrix. The polar component has low viscosity (<70,000 cP) and prevents adhesion between contact surfaces of sterilized devices. The formulations enable sterilization of medical devices like valves without lubricants, reducing costs and simplifying manufacturing. The devices have good sealing and burst pressure after irradiation.
13. Radiation-Resistant Room Temperature Vulcanized Silicone Rubber Composition
SHANDONG UNIVERSITY, UNIV SHANDONG, 2010
Condensed room temperature vulcanized silicone rubber with radiation resistance for applications like aerospace, electronics, and nuclear industries. The rubber contains specific amounts of dihydroxydimethylsiloxane, fumed silica, antiradiation agent, crosslinking agent, and catalyst to provide radiation resistance. The components are kneaded at room temperature and heat treated before vulcanization. The radiation-resistant rubber can be molded at room temperature like regular silicone.
14. Thermoplastic Silicone Rubber Composition with Crosslinked Silicone Powder and Silicone-Modified Thermoplastic Polyurethane Resin
OLYMPUS CORP, 2010
Thermoplastic silicone rubber composition for medical devices that provides good flexibility, moldability, and sealing properties without plasticizer exudation. The composition is made by blending 100 parts of crosslinked silicone rubber powder with 5-150 parts of a silicone-modified thermoplastic polyurethane resin. This allows molding of medical devices like forceps and tubes with improved mechanical properties, moldability, and sealing compared to traditional silicone rubbers. The crosslinked silicone rubber provides flexibility and sealing, while the thermoplastic polyurethane enhances molding and reduces plasticizer migration.
15. Composite Silicone Material with Reinforcing Silica and Block Copolymer for Barrier Coating
FEDERAL NOE GUP G NII KHIM I T, FEDERALNOE GOSUDARSTVENNOE UNITARNOE PREDPRIJATIE GOSUDARSTVENNYJ ORDENA TRUDOVOGO KRASNOGO ZNAMENI NAUCHNO-ISSLEDOVATELSKIJ INSTITUT KHIMII I TEKHNOLOGII EHLEMENTOORGANICHESKIKH SOEDINENIJ, 2009
Biocompatible composite silicone material for barrier coating applications like medical implants that minimizes penetration of uncrosslinked gel components through the coating. The composite contains a reinforcing silica-filled silicone rubber with low vinyl group content, along with a block copolymer containing both phenylsiloxane and organosiloxane segments. The organosiloxane segment has functional groups to chemically bind to the rubber binder. This composite has reduced swelling under the influence of uncrosslinked silicone gel compared to regular barrier layers.
16. Silicone Rubber Medical Devices with Homogeneously Dispersed Micron-Scale Antimicrobial Preservatives
BAYER HEALTHCARE LLC, 2009
Silicone rubber medical devices like catheters with improved antimicrobial properties for preventing infections. The devices contain homogeneously dispersed preservatives with small particle sizes in the silicone rubber matrix. The preservatives are suspended in a medium like a silicone polymer or solvent. The suspension is mixed into the rubber formulation before curing. The dispersed preservatives provide long-term antimicrobial effectiveness against bacteria and fungi on the device surface. The preservatives have average particle sizes of 1-30 microns and a distribution of 0.1-30 microns.
17. Lightweight Silicone Implant with Adhesively Bonded Foamed Sponge or Capsule Core
2006
A lightweight silicone implant that reduces weight compared to conventional implants. The implant is made by coating a foamed silicone sponge or empty silicone capsules with an adhesive and bonding a silicone block or cohesive gel bag to the surface. This provides cushioning, elasticity, and biocompatibility like natural tissue. The foamed sponge or empty capsules make the implant lighter and easier to shape for surgery. The adhesive bonding prevents collapse and maintains shape.
18. Polyolefin-Based Resin Composition with Dynamically Crosslinked Liquid Silicone Rubber for High-Temperature Sterilization Seals
WACKER ASAHIKASEI SILICONE CO, WACKER ASAHIKASEI SILICONE CO LTD, 2003
Sealing material for food and medical applications that does not lose sealing properties during high temperature sterilization and does not contain impurities affecting hygiene. The sealing material is a polyolefin-based resin composition for cap liners that can be molded into seals for container caps. It contains a specific amount of an addition reaction curable liquid silicone rubber composition added and dynamically crosslinked inside a kneading machine. The composition has viscosity of 11 to 10,000 Pa·s at 25°C and shear rate of 0.9 s. The dynamic crosslinking inside the kneader prevents impurities from forming and maintains sealing properties during sterilization.
19. Low-Bleed Silicone Gel with Controlled Crosslinked Polymer Structure and Reduced Extractable Silicone Content
イネームド ディヴェロプメント カンパニー, NAMED DEVELOPMENT CO, 2000
A low-bleed silicone gel suitable for use as a filler in soft tissue implants like breast prostheses. The gel has reduced extractable silicone compared to conventional gels, making it less prone to migration and leakage. The gel is made by crosslinking specific silicone polymers with controlled molecular weights and vinyl group distributions. This results in a pseudo-gel with less than 15% extractable silicone, compared to around 35-45% for conventional gels. The reduced extractable silicone prevents gel bleedage and migration when implanted in tissue.
20. Optical Silicone Composition with Vinyl and Cyclohexyl Terminated Organopolysiloxane Structures
KONICA CORP, KONISHIROKU PHOTO IND, 2000
An optical silicone composition that provides a cured product with excellent transparency, high refractive index, and low birefringence for use as an optical material like lenses, coatings, matching materials, and core materials. The composition contains specific organopolysiloxane structures with vinyl and cyclohexyl end groups, along with other components like methylhydrogenpolysiloxane and cyclohexylhydrogenpolysiloxane.
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