Envisioneering Medical Technologies, a developer and manufacturer of diagnostic and treatment guidance systems for the healthcare industry, has introduced the new TargetScan Touch® System for prostate imaging and biopsy. The technology features a dual-channel prostate biopsy needle guide, which is insert molded by Plas-Tech Engineering Inc., a leading custom molder of medical devices based in Lake Geneva, Wis.
Envisioneering’s new diagnostic and treatment system combines proprietary robotic ultrasound technology with the capability to perform precise, targeted prostate biopsies and treatments in order to add confidence to patient care. The TargetScan Touch® System is the only stereotactic prostate biopsy system to employ mapping technology combined with 3-D image acquisition. Leveraging the TargetScan Touch® biopsy coordinates, physicians can target and monitor any planned points and preferred zones in the prostate throughout the patient’s course of care. Unlike random sampling, this systematic approach supports multi-sample, repeatable biopsies, targeting precise locations.
The dual-channel prostate biopsy needle guide is a key component which is mounted to the biopsy system hardware. It is composed of two 13-gauge stainless steel tubes which are insert molded with acrylonitrile-butadiene-styrene (ABS) resin. The tight-tolerance part is six in. long and has an inner diameter of 0.071-in. The disposable needle guide serves as the pathway for the bendable biopsy needle to the target tissue. It is precisely formed to provide a consistent geometry for the needle to pass through, according to Michael Belgeri, Director of Operations for Envisioneering Medical Technologies. “The part has a complex geometry which requires tight sealing at four locations, with a smooth flash-free finish for patient comfort,” said Belgeri.
A critical factor was defining the processing requirements of the metal tubes, according to Scott Smith, VP of Sales and Marketing for Plas-Tech Engineering. The company’s quality team performed a detailed analysis of samples from the metal tube supplier, which resulted in the pairing of the tubes for placement in the mold to be eliminated. The tubes can be randomly selected since they are all within required tolerances for insert molding. This effort significantly reduced the cost of the finished product.
Among the key processing challenges was positioning the parts correctly in the mold and filling completely without blowing the stainless steel tubes out of position and creating flash across the holes. Core pulls are sequenced appropriately and shutoffs and inserts are high tolerance. Stainless steel tube bends and ID are held to +0.001 in. The ABS grade is FDA approved, offering strong dimensional stability and compatibility with ethylene oxide sterilization.
The TargetScan Touch® System allows the physician to insert a biopsy needle in the targeted area, and monitor both the accuracy of the biopsy needle position and the specific location of the tissue sample captured by the biopsy needle. Images can be captured and stored by the system to verify the location of the tissue samples. The system is more effective, precise, and systematic than traditional hand-held trans-rectal ultrasound (TRUS) biopsy systems.