Optical measurement speeds balloon implant production

A new gauge illustrates the increasing precision of medical processing in the United States.

Direct Flow Medical (Santa Rosa, CA) is now using an OptiGauge to design and perfect advanced catheter and balloon products for a minimally invasive implant used to treat patients with heart valve disease.

The OptiGauge provides non-contact measurements at up to 200 samples per second and can measure


Inflatable polyester fabric cuff conforms to aortic valve annulus and left ventricular outflow tract to form a seal.

objects as thin as 12 microns or as thick as 50 mm.  The OptiGauge uses advanced optical components to ensure operation without continuous calibration.  It can be integrated into a production facility's process control system.

"The OptiGauge allows us to understand our balloon manufacturing processes very clearly", says Gordon Bishop, vice president, research & development and co-founder of Direct Flow Medical.  "By obtaining precise, direct measurements of balloons upon line startup, we are able to make adjustments immediately and produce product that meet the design specifications from the beginning". 

Previously engineers would have to wait for the lot to be built and then destructively test and analyze the balloon using a microscope. 

"The OptiGauge has allowed us to achieve precise measurements with an added benefit of a reduced inspection cycle time", says Andrew LaPlante, quality engineer.  "Today, I can inspect a balloon in five minutes and obtain much more data.  Additionally, all the operators find the system extremely easy to use, and we are investigating other uses within our product suite."

OptiGauge is manufactured by Lumetrics.

Direct Flow Medical has received nine patents on its Transcatheter Aortic Valve Replacement (TAVR) technology, which is a non-metallic, expandable cuff, bovine pericardial tissue valve that allows physicians to position and/or reposition the device in order to assess outcomes prior to final device deployment. The repositionable "stentless" valve conforms to the native annulus resulting in tight sealing of the valve which minimizes leaks.

The most recent patent describes the inflatable body as made from a thin, flexible, biocompatible material that may aid in tissue growth at the interface with the native tissue. A few examples of material that could be used are listed as polyester, fluoropolymer, or woven material such as stainless steel or platinum.



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