University of Galway and Massachusetts Institute of Technology (MIT) research teams have described a development in medical device technology that could result in intelligent, enduring, and customized treatments for patients.
A smart implanted device that can administer a drug and sense when it is starting to be rejected has been developed by the transatlantic partnership. It uses AI to modify the shape of the device to maintain drug dosage and simultaneously avoid scar tissue buildup.
The study was published in the journal Science Robotics.
The patient’s reaction to a foreign body is a major obstacle preventing implantable medical device technologies from unlocking sophisticated therapeutic interventions in healthcare, such as insulin release to treat diabetes.
Dr. Rachel Beatty, University of Galway, and co-lead author on the study, explained: “The technology which we have developed, by using soft robotics, advances the potential of implantable devices to be in a patient’s body for extended periods, providing long-lasting therapeutic action. Imagine a therapeutic implant that can also sense its environment and respond as needed using AI this approach could generate revolutionary changes in implantable drug delivery for a range of chronic diseases.”
A University of Galway-MIT research team to enhance medicine administration and lessen fibrosis created first-generation flexible devices, sometimes known as soft robotic implants.
Despite this success, the team believes the technology is one-size-fits-all because it did not take into account how differently each patient reacts and responds, or the progressive nature of fibrosis, where scar tissue builds up around the device, encasing it, impeding and blocking its function, ultimately forcing it to fail.
The latest research, published today in Science Robotics, demonstrates how they have significantly advanced the technology using AI making it responsive to the implant environment with the potential to be longer lasting by defending against the body’s natural urge to reject a foreign body.
This is a new area of research that can have implications in other places and is not solely limited for the treatment of diabetes. Our discovery could provide consistent and responsive dosing over long periods, without clinician involvement, enhancing efficacy and reducing the need for device replacement because of fibrosis.
Professor Garry Duffy
Dr. Beatty added: “I wanted to tailor drug delivery to individuals, but needed to create a method of sensing the foreign body response first.”
The research team used a new method called mechanotherapy, in which soft robotic implants move the body on a regular basis, such as expanding and deflating, to assist reduce the creation of scar tissue. The timed, repetitive or varied movements help to prevent scar tissue from forming.
The implantable device’s conductive porous membrane, which can detect when pores are clogged by scar tissue, is the secret to its cutting-edge technology. It recognizes the obstructions because cells and the substances they make interfere with electrical signals that pass through the membrane.
The creation of scar tissue on the membrane was evaluated for electrical impedance, and a correlation was found. Regardless of the degree of fibrosis present, a machine learning algorithm was also created and put into use to anticipate the quantity and force of actuations necessary to achieve constant drug dosage.
The researchers also investigated the device’s capacity to deliver medication gradually with a surrounding fibrotic capsule of various thicknesses using computer simulations.
According to the research, altering the force and frequency of the device’s motion or shape changes allowed it to release more medication and avoid the formation of scar tissue.
Professor Ellen Roche, Professor of Mechanical Engineering at MIT, said: “If we can sense how the individual’s immune system is responding to an implanted therapeutic device and modify the dosing regime accordingly, it could have great potential in personalised, precision drug delivery, reducing off-target effects and ensuring the right amount of drug is delivered at the right time. The work presented here is a step towards that goal.”
Professor Garry Duffy, Professor of Anatomy and Regenerative Medicine at University of Galway, and senior author on the study, said: “The device worked out the best regime to release a consistent dose, by itself, even when significant fibrosis was simulated. We showed a worst-case scenario of very thick and dense scar tissue around the device and it overcame this by changing how it pumps to deliver medication. We could finely control the drug release in a computational model and on the bench using soft robotics, regardless of significant fibrosis.”
A completely autonomous closed-loop implants that not only lessen fibrotic encapsulation but also detect it over time and intelligently change their medication release activity in response may be made possible, according to the research team’s medical device breakthrough.
Professor Duffy added: “This is a new area of research that can have implications in other places and is not solely limited for the treatment of diabetes. Our discovery could provide consistent and responsive dosing over long periods, without clinician involvement, enhancing efficacy and reducing the need for device replacement because of fibrosis.”
The research was funded in part by Science Foundation Ireland’s Research Centres for Advanced Materials and BioEngineering Research (AMBER) centre and Medical Devices (CÚRAM), the European Union’s Horizon 2020 framework and the Mechanical Engineering Department at MIT.
