Our Work
Translating an early-stage physician concept into a functional braided multilumen catheter system for pre-clinical evaluation.
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Developing an ultra-thin-wall braided delivery sheath for a peripheral stent, solving stent loading challenges through rapid iterative engineering.
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Interventional Cardiology
Project Overview
A physician approached OPM with an early-stage concept for an interventional coronary catheter designed to make interventions in difficult-to-reach areas of the heart easier for interventional cardiologists. At the outset, the idea existed primarily as a napkin sketch supported by filed patents, with no clear path to feasibility or manufacturability. The challenge was to translate that initial concept into a functional catheter-based system that could be evaluated in a clinically-relevant setting.
Approach
OPM worked closely with the physician to turn the high-level concept into a feasible device design. Starting from the original sketch, the team assessed the core customer requirements, identified technical constraints, and developed several configurations to determine the most practical design path. A major focus was the actuation method, as clinician control and usability were critical to the success of the device. Through iterative development and hands-on problem solving, OPM refined the system into a braided multilumen design that balanced performance and control.
Technical Specifications
Results
The final device successfully advanced from concept to a working interventional system and completed pre-clinical studies. By helping move the idea from a rough sketch to a functional, manufacturable catheter-based device, OPM enabled the physician and company to demonstrate feasibility and meaningfully de-risk the program. The company is now seeking funding to support regulatory approval efforts and broader commercialization of the device.
Peripheral Vascular
Project Overview
A small but highly-skilled engineering team approached OPM about a delivery sheath for a peripheral stent. The company wanted a delivery sheath which would have the rigidity to load and deploy a stent while being gentle to loading of a stent with an easy-to-tear covering on the stent.
Approach
The team sought an extremely thin-walled approach. By utilizing a 0.00075" PTFE liner, braiding with 0.0005" x 0.0025" 304V Stainless Steel flat wire, and jacketing with a 0.0015" wall Pebax extrusion, OPM was able to produce a braided shaft with a sub-0.003" wall in the 7Fr range.
To ensure rigidity in spite of the ultra-thin wall, the team experimented with different jacket shore hardnesses, eventually settling on a 72D Pebax material. However, the stent covering was tearing upon loading into the sheath. After trying multiple common tipping options such as 25D and 35D Pebax, the team settled on a 40D Pebax with Barium Sulfate (BaSO₄) additive for radiopacity during preclinical studies.
Finally, the stent loading process was problematic, sometimes damaging the stent covering. The team experimented with different catheter tipping options to address this problem, eventually settling on a heated die flaring process to allow a clean loading into the braided catheter.
Technical Specifications
Results
The company has completed design verification testing and has plans to move the technology forward to pilot clinical use.
