Dec 3 2006
GE Plastics announced that its Lexan* HPX resin - a tough, high-tech transparent polycarbonate (PC) widely used in critical healthcare applications - has been selected by PENTAX to mold a specialized Intlock ITL-S disposable blade for the company's new Airway Scope AWS-S100 video laryngoscope. Lexan HPX resin was selected by PENTAX for the material's exceptional high-performance properties, including outstanding mechanical strength and toughness, incredible smoothness, and excellent transparency.
The new Airway Scope AWS-S100 is a rigid video laryngoscope for intubation coupled with a video monitor to enhance the ease of use while providing accurate verification during tracheal intubation procedures. PENTAX selected GE's Lexan HPX resin for its excellent impact resistance, which is important to avoid cracking of the material while the blade is inside the oral cavity. The material's smooth surface finish facilitates the insertion of the intubation tube into the trachea, helping to alleviate forces traditionally applied during insertion that can damage the patient's teeth. And, Lexan resin's transparency was critical for the best imaging performance.
PENTAX also selected GE's Lexan HPX resin series for its greater inherent lubricity vs. standard PCs, impact resistance, clarity, and biocompatibility1. The company further benefited from the support GE Plastics provided in obtaining regulatory approval from the Japanese government.
According to Clare Frissora, market director for Healthcare, GE Plastics, this specialty grade of Lexan resin was developed especially for the demands of the global healthcare industry. Medical device manufacturers are asking for innovative materials that provide increased design flexibility, while meeting stringent requirements for biocompatibility1 and reliable high performance, without trading off processing efficiencies. GE has responded by developing new generations of advanced materials like Lexan HPX resin to address the needs of designers, OEMs, and molders serving the healthcare industry.
The typical practice of tracheal intubation, a procedure to open the respiratory pathway in instances of blockage, constriction, or to assist in certain anesthesia delivery needs, requires the use of force to separate the upper portion of the palate and the base of the tongue to place the laryngoscope and insert a tube. Further, it is difficult to use traditional laryngoscopes due to limited visibility. Such procedures using traditional laryngoscopes may also have a lasting impact on the patient, as it is fairly common for a patient's teeth to be chipped or broken as a result of the procedure. The new PENTAX Airway Scope AWS-S100 seeks to reduce these complications and aid the speed and accuracy of such procedures. With this device, there is no need to extend the patient's neck or apply excessive force. Its enhanced ease of use allows healthcare staff, even those with less experience, to perform fast and accurate tracheal intubation, reducing risks for all involved.
The Intlock blade encases the AWS-S100 scope, which has an imaging charge-coupled device (CCD) and LED light attached to its tip. The clear PC blade enables optimal visibility during tracheal intubation procedures, which are viewed on the Airway Scope's video monitor. The complex Intlock component also incorporates a channel for a suction catheter, permitting aspiration treatment inside the oral cavity if required.
The new disposable Intlock blade helps to eliminate concerns about infection as compared to traditional metal blades that must be resterilized after use, typically via steam autoclave.
We are very pleased with the results, especially in the other ways that GE Plastics demonstrated its value as a materials supplier, said Yukio Taniguchi, PENTAX group leader. Usually a material supplier just provides the material, but in addition to supplying material, GE Plastics added significant value by supporting our efforts to achieve regulatory compliance. We expect similar support from GE as we submit the device for FDA approval in the United States. In addition, GE's well-known Lexan resin brand is a major advantage in marketing the scope.
The Lexan HPX resin series is a medium-flow resin offering excellent processability, including enhanced flow and release as well as very low temperature ductility vs. standard PCs. It is biocompatible1 as per ISO 10993.