Fortunately, it turns out that one of the world’s leading fiber-integrated sensor development programs is only miles away from a medical device company that is extremely interested in incorporating such technology into their myriad of products.
Just a few weeks ago, Bloomington-based global medical technology company Cook Medical entered into a senior research agreement with the Fiber and Additives Manufacturing Systems Lab at the Luddy School of Informatics, Computing and Engineering from Indiana University. The collaboration will explore the integration of FAME’s ‘smart fibers’ into Cook’s products to facilitate continuous, real-time monitoring of various bodily functions during procedures.
“You can monitor with the fiber that’s attached along the catheter in one form or another, so that whatever you deliver is delivering the result you expect,” said Alexander Gumennik, assistant professor of intelligent systems engineering. at the Luddy School and director of the FAMES Lab. . “Then, in case the situation changes for the better or for the worse, you decide to stop delivering or delivering something else. “
The technology in question is called Very Large Scale Integration for Fibers, which uses a complex combination of material processing techniques to integrate micro- and nano-sensors along a fabric-like fiber. This sort of thing is of interest to companies like Cook, because it would theoretically allow real-time monitoring of a patient’s condition while inserting, for example, an endoscope or catheter.
“All our devices currently
are mechanical in nature, ”said Sean Chambers, director of the New Ventures corporate research program at Cook Medical. “You can navigate the body with them, but they don’t provide any data to the clinician about local conditions. We have seen a technology that allows the Alexander team to make computers out of fiber. If you could put a computer in a fiber, then we could probably fit it into our devices and be able to measure things like blood pressure and temperature.
The current agreement between Cook and IU lasts 12 months. Meanwhile, a small integrated team from the two institutions hope to produce a prototype that incorporates a sensor wire into a guidewire and catheter made by Cook. The device, if things went as planned, would be able to monitor a patient’s blood pressure in real time and across the length of the instrument.
If the collaboration bears fruit, it could become the first step in a long road towards the production and marketing of several instruments equipped with sensors. It would also be part of a national trend. Because at the present time, manufacturers of medical devices are in a hurry to integrate sensors into just about any instrument that one would like to name.
“I know it’s only been a few months, but it seems like a good marriage of our technology with Cook’s medical products, or with the idea of using that technology in things like catheters, so that we can monitor patients in. real time while they are undergoing a procedure, ”said Gumennik.
If it works, it could theoretically be applied to hundreds of items made by Cook. But tapping into this potential billion-dollar market has also happened for other medical device makers. Especially since the global medical device market is expected to reach more than $ 603 billion in sales by 2023, according to a study by Dutch information services company Wolters Kluwer.
“The integration of sensors into medical devices is a major industry trend right now,” said Amanda Pederson, editor-in-chief of the Medical Device and Diagnostic Industry, which covers 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 Persona “smart knee” implant, which received FDA clearance last August. The implant can measure and determine range of motion, number of steps, gait speed, and other gait measurements, which it then sends to Zimmer Biomet’s remote care management platform (developed with Apple to work with the Apple Watch) so that surgeons and patients can access it.
“It’s really cool because in the past surgeons had to trust anything the patient told them about how their post-operative recovery was going,” Pederson said. “It gives a more objective view of the actual performance of the knee implant for this patient. “
This last point illustrates the potential of medical devices integrated with sensors, whether it is the prototype of a “smart” catheter on which IU and Cook are working, or the knee from Zimmer Biomet. Data from devices, whether permanent or not, will provide oceans of information on their effectiveness that will be useful to everyone from manufacturers fine-tuning their products to insurance companies deciding which procedures they want to cover in their policies. plans.
It could also reduce the number of doctor visits for recovering patients.
“In the era of COVID, remote monitoring also reduces the need for patients to be seen in person at their doctor’s office,” said Pederson. “The objective is not only to collect the data, but to make it easier for doctors [and, in some cases, the patients themselves] to obtain actionable information from this data, for more personalized care.
While the use of fiber technology in medical devices can represent a huge market, Gumennik says this technology, and others like it, will find applications far beyond hospitals. For example, he believes that smart fibers could help advance quantum computing and could also be embedded in concrete in the form of sensor sheets, to detect stress on buildings or internal cracks.
The technology used to integrate computers and sensors into fiber is so new that industries are still bluelisting the ways such innovation could be used.
At this point, the UI and Cook teams meet every two weeks to discuss advancements in the development of the specialized fiber needed for the catheter project. Although each new application requires the production of a different type of fiber, integrated with different technological advantages and structural compounds, Gumennik said his lab is far enough along in the development process that creating a fiber for Cook does not. does not mean starting from scratch. The technology and equipment necessary for the manufacture of sensor wires are more or less mastered, so it is more a question of developing the right formula for this project.
“We have the manufacturing technology ready for us,” he said. “We have the toolbox which is universal, and we don’t start by developing the toolbox. We start by finding a material that, combined with the toolbox, can deliver our results.
Fortunately, the amount of smart fiber needed for the initial IU / Cook collaboration is quite low.
“We’re not even talking about 30 feet of fiber,” Gumennik said. “We are talking about fractions of tenths of a centimeter, so fractions of feet.”
IU is investing $ 350,000 in the project which, if successful, will result in the creation of a catheter and guidewire capable of monitoring a patient’s blood pressure along its length.
“We think it’s achievable, although 12 months is a bit of an aggressive schedule,” Chambers said. “But we hope to demonstrate the functionality of being able to measure blood pressure in one of our devices.”
If the project is successful, it could be the start of a longer relationship between Cook and the FAMES Lab. Along with the creation of a very extensive and very profitable range of Cook-built products.
“We think that could give us a platform to put a sensor into one of our catheters, guidewires, endoscopes, any minimally invasive product,” Chambers said. “And there are other technologies to be developed so that you can transmit energy and send and receive signals. You can monitor a patient remotely, so they don’t have to come back for follow-up.
“It would really start to change medicine. “•