DISTRIBUTION HEALTHCARE SOLUTIONS. Surgical Instruments SELECTION GUIDE

Transcription

1 DISTRIBUTION HEALTHCARE SOLUTIONS Surgical Instruments SELECTION GUIDE

2 New innovations in surgical instrumentation, in the hands of a skilled surgeon, can have a significant impact on patient outcomes. The effectiveness of these instruments is as much a function of the materials used in their manufacture as it is of their design. In this high-stakes field, choosing the right polymer is key to making sure each component performs flawlessly. From regulatory approvals and quality assurance, to manufacturing efficiency and in-service performance, the challenges in designing these components are very real. The PolyOne team of focused professionals is ready to assist you with product design, material selection, regulatory compliance, manufacturing support, global supply chain assistance, and more.

3 RIGID COMPONENTS: SPECIALIZED DEVICES FOR MEDICAL & DENTAL SURGICAL PROCEDURES (housings, covers, handles, triggers, battery panels, nozzles, cannulae, valves, control knobs) Copolyester, PBT & PC/Polyester Blends Rigid Component Solution Needs: Copolyester Eastman Tritan (Copolyester) High chemical resistance to drugs, lipids, and a wide variety of hospital disinfectants; excellent toughness and impact resistance; retains mechanical properties, clarity, color, and gloss after disinfection and sterilization (gamma, e-beam, EtO); does not contain BPA; biocompatible Materials compliant with ISO & USP Class VI, if required Polybutylene Terephthalate (PBT) PolyOne Trilliant (Copolyester) DuPont Crastin (PBT) Engineered solutions; good chemical resistance to disinfectants; V0 flammability performance; colorability; toughness; autoclave, radiation and EtO sterilization Excellent surface appearance; good printability; low extractables and volatiles; excellent gamma sterilization performance; good chemical resistance; alternative to nylon for low moisture uptake and dimensional stability; low wear/low friction Excellent rigidity & dimensional stability Polycarbonate/ Polyester (PC/PET & PC/PBT) Covestro Makroblend (PC/Polyester) Ultra-tough materials that meet demanding physical and environmental requirements; excellent resistance to harsh chemicals; opaque; skin contact biocompatibility available; flame retardant options available Mechanical property retention after sterilization Materials that do not irritate the skin Excellent toughness to meet durability requirements High Heat PC, Glass Filled PC & PC High Heat Polycarbonate (HH PC) Glass Filled Polycarbonate (GF PC) Polycarbonate (PC) PA, Rigid TPU & Rigid PVC Covestro Apec (HH PC) Trinseo CALIBRE (GF PC) Covestro Makrolon (PC) Trinseo CALIBRE & CALIBRE MEGARAD (PC) High heat transparent, strong co-polycarbonate; suitable for autoclave sterilization; good hydrolysis resistance and biocompatible 5101 & 5102 (10 and 20%, respectively) glass filled PC; high rigidity and dimensional stability; full biocompatibility; animal-derivative free; suitable for EtO and radiation sterilization Extremely robust with strength, hardness and rigidity; lightweight with glass-like transparency; biocompatible; sterilizable by gamma, EtO, e-beam and steam Transparent and opaque options; full biocompatibility; animal-derivative free; suitable for gamma and e-beam sterilization (2081); EtO and radiation sterilization (2061); custom colors Excellent chemical resistance to bodily fluids, drug solutions and disinfectants Polyamide (Nylon, PA) DuPont Zytel (PA66) DuPont Zytel (PA612) Good toughness, chemical resistance and colorability; excellent stiffness and strength; glass reinforced available; sterilizable by EtO, gamma, e-beam, and autoclave sterilization; subject to yellowing in most sterilization techniques, except EtO Good toughness, chemical resistance and colorability; sterilizable by EtO and autoclave sterilization (limited gamma/e-beam sterilization performance); improved dimensional stability, chemical resistance, and reduced aqueous extractables versus PA66 DuPont Zytel HTN (PA6T/XT, PA6T/66) Excellent dimensional stability, chemical resistance, and colorability; sterilizable by EtO, autoclave, gamma, and e-beam Arkema Rilsan Clear MED (PA) Transparency; chemical resistance; impact resistance; lightweight; sterilizable by gamma, EtO & steam; BPA-free

4 RIGID COMPONENTS: SPECIALIZED DEVICES FOR MEDICAL & DENTAL SURGICAL PROCEDURES (cont.) (housings, covers, handles, triggers, battery panels, nozzles, cannulae, valves, control knobs) PA, Rigid TPU & Rigid PVC Rigid Component Solution Needs: Polyamide (Nylon, PA) Arkema Rilsan MED (PA11) & Rilsamid MED (PA12) Chemical resistance; impact resistance; lightweight; dimensional stability; sterilizable by gamma, EtO & steam Materials compliant with ISO & USP Class VI, if required Rigid Polyurethane Rigid Polyvinyl Chloride (PVC) Covestro Texin PolyOne Resilience HC (PVC) Biocompatible; excellent chemical resistance; bondable to polar substrates like PC; sterilizable by gamma, EtO, e-beam and dry heat; rigid 65 to 80 Shore D grades Excellent chemical resistance; maintains physical integrity and color after frequent cleaner and/or disinfectant wipe down; inherently flame retardant to UL94 5VA; high impact toughness; USP Class VI; phthalate-free; sterilizable by gamma, EtO and steam Excellent rigidity & dimensional stability Styrenics & PC/ABS Blends Trinseo MAGNUM MED (ABS) INEOS Styrolution NAS (SMMA) Opaque; full biocompatibility; suitable for EtO and radiation sterilization; custom colors Sparkling clarity; color neutrality; good rigidity; easy processing; no pre-drying needed; excellent alcohol resistance Mechanical property retention after sterilization Styrenics INEOS Styrolution Zylar & Clearblend (MBS) INEOS Styrolution Lustran (SAN) INEOS Styrolution Styrolux (SBC) Exceptional toughness; excellent clarity; low specific gravity (more parts per lb. of resin); no pre-drying needed; excellent thermal stability; superior chemical resistance Rigid; heat resistant; outstanding transparency; good overall chemical resistance; superior processing; good scratch resistance Good transparency and excellent toughness; easy and versatile processing; great for adding toughness to styrenic polymer blends Materials that do not irritate the skin INEOS Styrolution K-Resin (SBC) INEOS Styrolution Terlux HD (MABS) Sparkling clarity; impact toughness; stiffness; exceptional gloss Good clarity; good heat and overall chemical resistance; good impact strength; good solvent bonding to PVC; outstanding surface quality Excellent toughness to meet durability requirements Excellent chemical resistance to bodily fluids, drug solutions & disinfectants Polycarbonate/ ABS (PC/ABS) POM (Acetal), PP & PE Polyoxymethylene (Acetal, POM) INEOS Styrolution Lustran (ABS) & Novodur HD (GF ABS) Covestro Bayblend (PC/ABS) Trinseo EMERGE MED (PC/ABS) DuPont Delrin (POM) Flint Hills (PP) Opaque appearance; outstanding chemical resistance; high impact strength; excellent balance of properties; ease of processability; bondable Excellent mechanical and thermal properties; toughness, rigidity & dimensional stability; opaque; biocompatible options available; flame retardant options available Opaque; full biocompatibility, suitable for EtO and radiation sterilization; custom colors Excellent low wear/low friction; excellent surface appearance; good chemical resistance; alternative to nylon for low moisture uptake and dimensional stability; sterilizable by EtO and autoclave (not recommended for gamma or e-beam sterilization) Polypropylene (PP) & Polyethylene (PE) Pinnacle (PP) Dow Health+ Polymers (PE) Lyondellbasell (PP) & (PE) Good strength and stiffness; easy processing; sterilizable grades available

5 FLEXIBLE COMPONENTS: SPECIALIZED DEVICES FOR MEDICAL & DENTAL SURGICAL PROCEDURES (grips, o-rings, gaskets, buttons, caps, tubing, seals, etc.) TPE, TPC-ET, TPU, TPV & Flexible PVC Flexible Component Solution Needs: Comfortable handles & grips Elastomers (TPE) PolyOne Versaflex HC Overmolding Series (TPE) Arkema Pebax MED (TPE) Unlimited design freedom; easy processing; biocompatible; colorable; hardness ranges Shore A; autoclave, radiation, and EtO sterilizable; bondable to many substrates; customizable haptics Fatigue resistance; soft touch; chemical resistance; low energy return (exceptional responsiveness); sterilizable Water-tight seals Polyester Elastomers (TPC-ET) DuPont Hytrel (TPC-ET) PolyOne NEU Specialty Engineered Materials BPA-free; excellent flex fatigue and toughness; low temperature flexibility; good chemical resistance; sterilizable by EtO, gamma, e-beam, and autoclave (limited autoclave performance with lower durometers) Short-term in vivo solutions; biocompatible; various durometer ranges with customization; autoclave, radiation and EtO sterilizable Durable buttons or knobs Polyurethane PolyOne Trilliant Engineered solutions; various durometers with functional performance enhancement; autoclave, radiation and EtO sterilization Chemically resistant materials for the user interface Covestro Texin Biocompatible; soft touch; sterilizable; good chemical and abrasion resistance and toughness; excellent bonding to polar substrates like PC; 70 to 95 Shore A grades Vulcanizate (TPV) PolyOne Versalloy (TPV) Exxon Mobil Santoprene (TPV) Proven healthcare solutions with hardness ranges Shore A; autoclave; radiation and EtO sterilizable; natural and colorable; smooth texture; bonds to PP Durable sealing performance; elastic recovery; excellent chemical resistance; compliance with medical standards Flexible Polyvinyl Chloride (PVC) PolyOne Geon HC (PVC) Engineered exclusively for the healthcare market; transparent and opaque colors; durometer ranges from 55A to 40D; gamma and EtO sterilizable Thermoset Elastomers Thermoset Elastomers SBC Dow Corning Liquid Silicone Rubber (LSR) Dow Corning High Consistency Rubber (HCR) Biocompatible; non-irritating and non-sensitization; sterilizable; made without plasticizers, phthalates or latex; used in Liquid Injection Molding (LIM) process Biocompatible; non-irritating and non-sensitization; sterilizable; made without plasticizers, phthalates or latex; used in extrusion or compression molding process Styrene Butadiene Copolymer (SBC) INEOS Styrolution Styroflex (SBC) Rubber-like mechanics; outstanding resilience; toughness and transparency; extremely high elasticity; excellent bonding to other polymers

6 CUSTOM POLYONE SOLUTIONS FOR SURGICAL INSTRUMENTS Custom Solution Needs PolyOne Custom Solutions Specialized materials to meet unique application requirements PolyOne Trilliant Healthcare products are a line of customized solutions specific for regulated medical devices; color branding expertise FDA-registered pre-colored resins and masterbatch options; color coding for safety and brand recognition PolyOne collaborates with key material suppliers to provide FDA-approved pre-colored resins PolyOne OnColor HC Plus offers customizable color masterbatch solutions pre-certified for biocompatibility using ISO and USP Class VI test protocol Reduced growth of microbes PolyOne WithStand additive technologies inhibit growth of microbes that often cause odor, staining, and loss of mechanical properties of polymer materials

7 POLYONE DISTRIBUTION Healthcare Supplier Line Card You face a unique set of challenges when designing parts for the healthcare industry. In addition to maintaining an effective manufacturing and supply chain operation, you re challenged with designing products that must meet strict regulatory and quality assurance standards. At PolyOne Distribution, we help you achieve these goals with our comprehensive portfolio of leading suppliers, on-time delivery and a host of services focused on helping you succeed. RESOURCES

8 PATIENT FIRST HEALTHCARE SOLUTIONS To deliver patient safety, security and comfort, start with PolyOne healthcare materials and solutions. Your focus is on developing medical devices that greatly improve patient outcomes, so you know that there is no room for product development shortcuts. High-stakes healthcare applications demand the best in materials science. PolyOne Distribution provides you more than the world s most advanced polymer materials. We help you streamline design, manufacturing and supply chain processes, including navigating regulatory demands and beyond. SURGICAL INSTRUMENTS THAT DELIVER PERFORMANCE Your surgical instruments need to enable physicians to perform sometimes complex and lifesaving surgeries. By choosing the right polymer for your device, you can help make these instruments more reliable and precise in their function, ultimately improving patient outcomes. Trocars Drills Surgical Saws Scalpels Clip Appliers Skin Staplers Forceps Ligasure Tools Arthroscopes Endoscopes Electrosurgical Tools Lancets POLYONE Copyright 2018, PolyOne Corporation. PolyOne makes no representations, guarantees, or warranties of any kind with respect to the information contained in this document about its accuracy, suitability for particular applications, or the results obtained or obtainable using the information. Some of the information arises from laboratory work with small-scale equipment which may not provide a reliable indication of performance or properties obtained or obtainable on larger-scale equipment. Values reported as typical or stated without a range do not state minimum or maximum properties; consult your sales representative for property ranges and min/max specifications. Processing conditions can cause material properties to shift from the values stated in the information. PolyOne makes no warranties or guarantees respecting suitability of either PolyOne s products or the information for your process or end-use application. You have the responsibility to conduct full-scale end-product performance testing to determine suitability in your application, and you assume all risk and liability arising from your use of the information and/or use or handling of any product. POLYONE MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, either with respect to the information or products reflected by the information. This literature shall NOT operate as permission, recommendation, or inducement to practice any patented invention without permission of the patent owner. Makrolon, Apec, Bayblend, Makroblend and Texin are trademarks of the Covestro Group.