At MD&M West 2020, Trelleborg’s healthcare & medical operation will showcase its GeoTrans geometric transition extrusion technology intended to improve part quality, device function, and longevity of medical devices using high-consistency rubber (HCR) silicone. It also removes the risks and labor of assembly and secondary processes, the company reported in a news release.
GeoTrans technology eliminates the use of assembled joints that can be weak, creating failure modes or internal misalignments in which fluids can become turbulent or stagnant, Trelleborg reported. This could increase component strength and improve the medical device’s longevity and robustness.
“HCR silicone’s unique green strength, the strength of rubber in its unvulcanized state, allows for highly complex geometries in continuous extrusion processes," stated Dan Sanchez, product manager at Trelleborg’s healthcare & medical operation, in the release. "In the GeoTrans process, tool components can be moved during extrusion to substantially change cross sections. This opens up new design possibilities in a wide range of medical devices, including wound drains and spinal and hemodialysis catheters.
“A major advantage to the device manufacturer is that overall processing time and costs can be reduced," he continued. "Although running a simple extrusion is faster than running a geometric transition extrusion, overall manufacturing, assembly, and quality testing time can be significantly shortened with the GeoTrans process. For instance, the production volume of many long-term implants does not justify complex, automated assembly. However, a redesign to include a geometric transition can eliminate the need for manual assembly of a portion of the device. Additionally, with fewer components and secondary processes, the design validation step may be significantly shorter. The process for achieving compliance with international standards and regulatory requirements for a single part is also greatly simplified, due to risk mitigation.”
Trelleborg offered the following examples of possible geometric transitions with GeoTrans technology:
- Transitioning from a single lumen tube to a multi-lumen tube or splitting a multi-lumen tube into two or three single lumen tubes.
- One or more lumen stops and restarts within a multiple lumen tube, eliminating the need for secondary operations, such as backfilling a lumen used for filling a catheter balloon.
- A wound drain that comprises three separate pieces--an extruded tube, complex cross-section extrusion, and molded hub--can be created as a single extrusion with two or more distinct geometric cross-sections and a smooth, integrated transition instead of a hub.
- Off-ration bump tubing, for applications requiring a variable outer diameter with either a constant or variable inner diameter, can be created with very short transitions down to fractions of an inch.
- Bifurcated tubing, which traditionally has four components--a two-lumen tube, two single-lumen tubes, and a molded hub--can be produced in one extrusion process.
The GeoTrans extrusion process has been used to manufacture products between 7 French and 24 French (on the catheter scale), it was reported.
Visit Trelleborg at MD&M West Booth #2601 February 11-13.