Polyurethane Thin-Film Welding for Medical Device Applications Manufacturers Seeking to Replace PVC Or Latex Must Understand How Bonding Processes Affect Materials

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Polyurethane Thin-Film Welding for Medical Device Applications Manufacturers Seeking to Replace PVC Or Latex Must Understand How Bonding Processes Affect Materials September 2002 http://www.devicelink.com/mddi DesignDesign andand DevelopmentDevelopment Learning from Failure: How to Profit from Prototyping Setbacks Improve Product Development with Innovation Mapping Understanding Sterilization Options, p. 52 The Ins and Outs of Welding Polyurethane, p. 62 A Canon Communications LLC Publication THERMOPLASTICS Polyurethane Thin-Film Welding for Medical Device Applications Manufacturers seeking to replace PVC or latex must understand how bonding processes affect materials. Tilak Shah HERMOPLASTIC FILMS properties; and reductions in have been used in flexible the thickness of a film can medical product applica- lower costs and increase the tions since the 1960s, when area obtained from a given plasticized polyvinyl weight of polymer yield per chloride (PVC) blood square meter.2 Tstorage bags replaced glass bottles.1 In Amorphous polymers re- the 1970s, PVC became the material of spond better to welding than choice for Band-Aids, and a decade later crystalline polymers do be- the use of polymeric film patches in sur- cause they soften, melt, and gical draping became popular, replacing resolidify gradually. Howev- latex films. In the 1990s, the use of organ er, some amorphous resins bags, drug-delivery patches, and breath- with high melting points, able films for wound care increased dra- such as polycarbonate and matically, making films much in demand polysulfones, are difficult to in the medical industry. However, health weld.3 Crystalline polymers, and environmental concerns about PVC In selecting films for medical devices, designers which have high, more de- and latex films have driven the develop- must consider several factors. fined melting points, tend to ment of alternative materials for these ap- melt and resolidify quickly, plications (see sidebar on p. 65). WELDABILITY OF THERMOPLASTICS making them challenging to weld. Among Nearly all thermoplastics can be used in the crystalline polymers are polyethylene, film form as thin, soft, flexible, elas- Films most commonly used in the polypropylene, nylon, thermoplastic tomeric materials that can be folded or medical industry include high- and low- polyesters, acetal, and polyphenylene creased without damage. In selecting density polyethylene and polypropylenes sulfide. films for medical devices, designers must from the polyolefin family, plasticized Thermoplastic polyurethane, an aro- consider a variety of factors, including PVC, polyurethane elastomers, and matic or aliphatic polymer, is well suited cost, biocompatibility, sterilizability, me- breathable specialty films such as for use in flexible medical products such chanical toughness, elasticity, optical clar- polyester. Designers need a clear under- as storage and collection bags and many ity, leachability, barrier properties, drug standing not only of a material’s proper- other types of flexible containers and sim- interaction, and sealing and assembly ties, but also of how a particular welding ilar articles. characteristics. process will affect it. Polyurethane films offer some impor- The weldability of plastics is affected tant advantages over other films, includ- by various factors, including type of poly- ing PVC. They have similar welding char- Health and environmental concerns are mer; resin grade; presence of plasticizers, acteristics to PVC, provide strength equal prompting manufacturers to seek out lubricants, and other additives; and mois- to PVC in a thinner film, contain no plas- new applications for materials such as ture content. Thermal properties, molec- ticizers, are sterilizable by either EtO or polyurethane. To make effective use ular characteristics, and crystallinity of a gamma radiation, and have good alcohol of this material, however, designers polymer affect processing and film prop- resistance. Polyurethane films also can be must understand how it responds to erties; additives influence extrusion and readily sealed using radio frequency (RF) various bonding processes. orientation processes and improve film welding techniques. Photo courtesy of POLYZEN INC. THERMOPLASTICS Process Mechanism Special Features Suitable Materials Flame bonding Natural gas flame Continuous web application PVC to foam lamination Hot air gun Hot air or nitrogen Plastic welding rods Low melting plastic, PE Hot knife welding Heat from metal surface Bond in one plane Thermoplastic rubbers Hot plate welding Hot tool/die Draft angle of bar High temperature plastics Induction/impulse Resistance wire Straight line seal Olefins, low temperature films Dielectric – RF Loss in alternative electrostatic field Quick bonding Polar or amorphous elastomer Ultrasonic welding High-frequency compressive loading Sonic conductor Rigid plastics Solvent bonding Material swell/dissolve Chemical fusion Amorphous resin Table I: Fusion welding processes. Adapted from Encyclopedia of Polymer Science and Engineering (New York: Wiley). FILM-JOINING METHODS Response Material Loss Index Welding processes commonly used in (G=good, F=fair, P=poor, N=none) assembling medical devices from ther- ABS polymers 0.025 F–P moplastic films include RF welding, also known as dielectric sealing; ultra- Acetal resin 0.025 F–P sonic welding; direct thermal sealing; Cellulose acetate 0.15 F induction welding or sealing, and sol- DAP 0.04 F vent bonding (see Table I). Selecting the best process for bonding thin-film ma- Epoxy 0.12 F terials in the assembly of medical prod- Melamine 0.2 G ucts involves a number of considera- tions. The material itself is the primary Phenal formaldehyde 0.2 G factor. Size of the product, volume, pro- Polyamide 0.16 F cess capability, cycle time, and cost are Polycarbonate 0.03 F–P other critical variables. In each welding process, controlled PVDF 0.04 F heat is applied to the materials, caus- Polyester 0.05 F ing the plastic to melt in a narrow zone Polyethylene 0.0008 N at the joint interface. Pressure is applied and, once the heat is cut off, the mate- Polyimide 0.013 P rial cools and resolidifies, forming a PMMA 0.09 F weld bond. The amount of compression used is important, since too little or too Polypropylene 0.001 N much can result in a weak seal. A Polystyrene 0.001 N smooth, uniform bead along the weld PTFE 0.0004 N line is ideal. RF Welding. RF welding, a form of di- FEP 0.001 P electric heating, is one of the most wide- PVDF 0.05 F ly used methods for assembling medical devices. The process offers consistent PU film/foam 0.4 G quality; thin, strong weld lines; short seal- PVC film, flexible 0.4 G ing cycles for high output; minimal ther- TPE 0.13 F mal distortion of the film or substrate; and the ability to produce weld-edge tear Silicone 0.009 P–N seals. Of these, the most important ad- Urea formaldehyde 0.2 G vantage is extremely thin weld seams. Im- pulse welding and hot-bar sealing produce Table II. Response of polymers to dielectric heating. Adapted from JD Ferry, Viscoelas- a seal area that is about 1/8 in. wide—too tic Properties of Polymers (New York:Wiley, 1970), and S Saito and T Narajiman Jour- wide for some medical applications. For nal of Applied Polymer Science 2:1959, 93. applications such as containers, the width of the seam is not significant, but for im- ing must be poor conductors of electrici- lene, polystyrene, silicone, and rubber are plantable medical devices, a thinner seam ty, since a good conductor would act as among the materials that are not respon- is preferred. a short circuit, weakening the field near sive to the process. Polymers with strong The materials to be joined by RF weld- the conductor. Polyethylene, polypropy- dipoles respond best to RF welding. The THERMOPLASTICS POLYURETHANE FILM AS AN ALTERNATIVE TO PVC AND LATEX MATERIAL CHOICES nel, such as nurses and lab technicians, are For example, successful RF welding of particularly at risk for latex sensitivity be- polyurethanes requires special die designs, PVC. The most commonly used mate- cause of their high exposure to the material.7 modifications to conventional equipment, rial in the manufacture of flexible medical NRL alternatives include nitrile rubber, syn- and adjustments to the parameters of the devices, PVC has come under fire owing to thetic latex, styrenic elastomers, poly- welding process. The die determines the concerns about the use of phthalates as urethane, and silicone. width of the seam. A typical die design in- plasticizers and environmental problems Thermoplastic Polyurethanes. Ther- corporates an insulated knife that cuts and with disposal. The softness, flexibility, and moplastic polyurethanes contain no plasti- seals the film in one step. Using conven- low-temperature characteristics of PVC cizer and have a lower density than PVC, tional RF welding equipment with thin are determined by the type and amount of producing a higher film yield. The films films produces excessive arcing and weak plasticizer used in the compound. The most offer toughness and strength, and high water- seams. It is a technology that requires high- widely used plasticizer, di-ethylhexyl ph- vapor permeability. They can be sealed using level skills. thalate (DEHP), has been linked to toxic RF welding. Soft formulations can be dip effluents produced during manufacturing molded into gloves, although the process is CONCERNS ABOUT PVC and to the generation of hydrogen chloride more expensive than welding during incineration. Environmentalists Polyurethanes are thermoplastic rubbers Human exposure to DEHP can occur in have raised concerns that the disposal of made from isocyanates and are designated the
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