How IU’s Smart Fiber Laboratory Could Charge Cook Medical Devices

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Alexander Gumennik, Director of the Fibers and Additive Manufacturing Enabled Systems Laboratory at Indiana University, is working with Cook Medical to embed “intelligent fibers” like the ones shown here in medical devices. (Photo courtesy of the IU FAMES laboratory)

Fortunately, it turns out that one of the world’s leading programs for developing fiber-integrated sensors is only a few miles away from a medical technology company that is keen to incorporate this technology into its myriad of products.

Alexander Gumennik

Just a few weeks ago, Bloomington-based global medical technology company Cook Medical signed a master’s research agreement with the Fibers and Additive Manufacturing Enabled Systems Laboratory at Indiana University’s Luddy School of Informatics, Computing and Engineering. As part of the collaboration, the integration of FAME’s “intelligent fibers” into Cook’s products is being investigated in order to enable continuous real-time monitoring of various body functions during the procedures.

“You can monitor with the fiber, which is attached in some form along the catheter, so that whatever you deliver produces the expected result,” said Alexander Gumennik, Assistant Professor of Intelligent Systems Engineering at Luddy School and Director of the FAMES Lab . “If the situation changes for better or for worse, then decide whether to stop delivering or perhaps deliver something else.”

The technology in question is called Very Large-Scale Integration for Fibers, which uses a complex combination of material processing techniques to embed micro- and nano-sensors along a cloth-like fiber. Something like this is interesting for companies like Cook because it would theoretically enable real-time monitoring of the condition of a patient during the insertion of an endoscope or catheter, for example.

Sean Chambers

“All of our devices currently
are mechanical in nature, ”said Sean Chambers, director of Cook Medical’s New Ventures corporate research program. “You can use them to navigate your body, but they don’t give the clinician any information about the local area. We saw a technology that enables Alexander’s team to make computers out of fibers. If you can plug a computer into fiber, we could probably put that in our equipment and measure things like blood pressure and temperature. “

The current agreement between Cook and IU has a term of 12 months. During this time, a small, integrated team from both institutions is hoping to produce a prototype that integrates a sensor thread into a guidewire and catheter manufactured by Cook. If everything goes according to plan, the device could monitor a patient’s blood pressure in real time and over the entire length of the instrument.

If the collaboration bears fruit, it could be the first step on the long road to manufacturing and marketing multiple sensor-equipped instruments. It would also become part of a national trend. Because right now, medical device manufacturers are rushing to incorporate sensors into pretty much any instrument you want to name.

“I know it’s only been a few months, but this seems like a good connection between our technology and Cook medical products, or with the idea of ​​using that technology in things like catheters to monitor patients in real time.” while undergoing a procedure, ”said Gumennik.

Alexander Gumennik, director of Indiana University’s Fibers and Additive Manufacturing Enabled Systems Laboratory, is working with Cook Medical to embed “intelligent fibers” in medical devices. (Photos courtesy of the IU FAMES laboratory)

competition

If it works, it could theoretically be applied to hundreds of items made by Cook. But other manufacturers of medical devices have also tapped into this potentially billion-dollar market. Especially in light of the fact that the global medical device market is expected to reach sales of more than 603 billion US dollars in 2023, according to a study by the Dutch information service provider Wolters Kluwer.

“Embedding sensors in medical devices is a major trend in the industry right now,” said Amanda Pederson, news editor at Medical Device and Diagnostic Industry, which is responsible for the design, development, and manufacture of medical devices and diagnostics, as well as regulatory requirements. “There are so many examples of this trend that it would be difficult to list them all.”

One of the most interesting of these many products, Pederson said, is Zimmer Biomet’s “Smart Knee” Persona implant, which was approved by the FDA last August. The implant can measure and determine range of motion, number of steps, walking speed and other gait values, which it then sends to Zimmer Biomet’s remote care management platform (which was developed with Apple for the Apple Watch) for surgeons and patients to access can.

“This is really cool because in the past surgeons had to rely on everything the patient told them about their recovery from surgery,” said Pederson. “This gives a more objective view of the actual knee implant performance for that individual patient.”

This last point illustrates the potential of medical devices with embedded sensors, be it the “smart” catheter prototype IU and Cook are working on or Zimmer Biomet’s knee. The data from devices, whether permanent or not, will provide an ocean of information about their effectiveness that will be useful to everyone from manufacturers refining their products to insurance companies deciding which procedures to cover in their plans .

It could also reduce the number of visits to the doctor for recovering patients.

“In the COVID era, remote monitoring also reduces the need for patients to be seen in person at their doctor’s office,” Pederson said. “The goal is not just to collect the data, but to make it easy for doctors [and, in some cases, the patients themselves] in order to gain actionable insights from this data for more individual care. “

IU FAMES Lab Director Alexander Gumennik, left, works with technical staff Tyson Miller and Troy Leffel. (Photo courtesy of the IU FAMES laboratory)

Widely used applications

While the use of fiber technology in medical devices could be a huge market, Gumennik claims this and similar technologies will find application well beyond hospitals. He believes, for example, that smart fibers could advance quantum computing and could also be embedded in concrete as sensor foils to detect expansion in buildings or internal cracks.

The technology for embedding computers and sensors in fiber optics is so new that the industry is still making sky blue lists of how such an innovation could be used.

At this point, the IU and Cook teams meet every two weeks to discuss progress in developing the specialty fiber needed for the catheter project. Although each new application requires the production of a different type of fiber embedded with different technological properties and structural connections, Gumennik said his lab is advanced enough in the development process that for Cook developing a fiber doesn’t mean starting from scratch. The technology and equipment for producing sensor threads are more or less in hand, so it’s more about developing the right recipe for this project.

“We have the manufacturing technology ready for us,” he said. “We have the universal toolbox and we don’t start developing the toolbox. We start by finding a material that, in combination with the toolbox, can deliver our results. “

Fortunately, the amount of smart fiber needed for the initial IU / Cook collaboration is quite small.

“We’re not even talking about 30 feet of fiber,” said Gumennik. “We are talking about fractions of tenths of a centimeter, that is, fractions of feet.”

IU is investing $ 350,000 in the project, which, if successful, will result in the manufacture of a catheter and guide wire that can be used to monitor a patient’s blood pressure over its entire length.

“We think it’s achievable, although 12 months is a pretty aggressive schedule,” said Chambers. “But we hope to be able to demonstrate the functionality of blood pressure measurement with one of our devices.”

If the project works, it could be the beginning of a longer relationship between Cook and the FAMES Lab. Along with creating a very extensive, very profitable line of Cook products.

“We think it could provide a platform for us to insert a sensor into any of our catheters, guidewires, endoscopes, or any minimally invasive product,” said Chambers. “And other technologies need to be developed so that you can transmit energy and send and receive signals. You can remotely monitor a patient so they don’t have to return for a follow-up exam.

“That would really change medicine.”


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