MEDGADGET EDITORS EXCLUSIVE

Wrapping up this year and looking back on the particularly interesting developments in medical technology, we at Medgadget are impressed and very excited about the future. We’re lucky to cover one of the most innovative fields of research and one that improves and saves lives. Having a constant eye on what’s new in medtech, we present what we believe are the most novel, smart, and medically important technologies we encountered in this passing year. As in years past, a few trends have emerged.

Opiod Overdose Treatment
Opioid addiction, and accompanying overdoses, have become disturbingly common lately. A few technologies have sprung this year as a response.

Naloxone (aka Narcan) is an antidote that prevents opioids from binding to brain receptors, but when a person does overdose there may not be anyone around to administer the drug.

Researchers at Purdue University developed a smart overdose prevention system, which includes an implantable naloxone-releasing device, that can automatically halt an overdose without anyone’s intervention at all.

The system includes a wearable component that can detect the user’s breathing, via electrocardiography, and calculate the respiration rate. An implantable drug-releasing cartridge (pictured above) placed under the skin, can be made to release the naloxone if the breathing rate drops too low.

A similar, but drug-free device, has been developed for post-op patients and others on heavy opioid therapy. The Oxalert EPO from a company called Med-botics monitors patient SpO2 (oxygen saturation) levels and if those fall below 90%, it attempts to arouse the patient out of respiratory arrest using audible notifications via headphones, gentle electric shocks, or a combination of the two. No word on its availability for over-the-counter applications.

There’s now even an app that uses sonar to monitor the breathing rate of a user, which it can do from up to three feet away, to assess if someone is experiencing an overdose. The app imperceptibly bounces sound waves off a drug user’s chest and then analyzes them when they return, to assess the breathing rate. So far, the technology, created at the University of Washington, has accurately predicted overdoses 90% of the time in a study. The technology can be made to automatically connect the drug user undergoing an overdose, or those around, to emergency services.

Electromagnetic Signals Slow Parkinson’s, Treat Irritable Bowels, Improve Blood Pressure…

Buildup of β-amyloid plaques within the brain seems to be a cause of Alzheimer’s disease. The MemorEM system from NeuroEM Therapeutics delivers transcranial electromagnetic treatment, or TEMT, to the brains of Alzheimer’s patients targeting β-amyloid aggregates.

In animal studies, it was shown that TEMT does indeed prevent β-amyloid aggregates from forming and even disrupts existing conglomerations. In a study on eight patients who went through a treatment regimen, all but one showed either a pause or reversal in cognitive decline. If proven to work in larger groups of people, the treatment may become a common approach for dealing with Alzheimer’s from the earliest stages.

A new device called IB-stim from Innovative Health Solutions received FDA clearance to treat irritable bowel syndrome (IBS) by manipulating the electrical signals reaching the brain.

It looks very similar to a hearing aid, but instead of processing sound, it uses three electrodes to deliver electrical impulses to the peripheral cranial nerve branches of the ear. These nerve bundles provide an efficient path into the regions of the brain that relate to pain perception. The artificial signals sent by the device seemingly disrupt signals coming from the gut, and the result is that there should be no sensation of pain.

This has been confirmed in a double blind, randomized, controlled clinical trial evaluating the IB-Stim versus a placebo. The patients in the study, 70% of whom did not respond positively to an average of four drugs, responded well to the IB-Stim.

Orchestra BioMed, a company out of New Hope, Pennsylvania, won the European CE Mark of approval for the Moderato implantable pulse generator which delivers Orchestra’s unique BackBeat Cardiac Neuromodulation Therapy (CNT) to treat hypertension.

High blood pressure is typically treated using drugs, but BackBeat allows even existing cardiac implants to deliver therapy in a novel way by modulating the bioelectronic signals associated with blood pressure control.

In Europe, the MODERATO I clinical trial showed that BackBeat can lower systolic blood pressure by an average of 23 mmHg after a two-year follow up. That’s pretty impressive, as that should lead to lower potential for cascading conditions while increasing overall health.

The FDA cleared the Monarch external Trigeminal Nerve Stimulation (eTNS) System from NeuroSigma to treat ADHD in kids between 7 and 12 years old. The system has already been used to treat posttraumatic stress disorder (PTSD), epilepsy, and depression.

It delivers low-energy electrical current through an electronic patch attached to the forehead, creating a tingling sensation, but otherwise not causing any pain or discomfort. The therapy is by prescription only, though it’s still not clear how trigeminal nerve stimulation actually works. It has been shown that it does increase brain activity in regions responsible for mental attention, behavior, and emotional response.

There are implantable devices out there that are very effective at treating depression in many patients. These usually look like pacemakers and they have electrical leads stretching out, usually, to the vagus nerve. Of course implants have a whole host of consequences, including surgical risk, a limited battery lifetime, and a chance that the therapy won’t work and explantation will be required.

Researchers at the University of North Carolina have been testing a new approach, called transcranial alternating current brain stimulation (tACS), to offer a different, non invasive option. The technology relies on an electrode headset that looks like an EEG cap, but instead of listening for faint brain signals, it delivers weak alternating current pulses in a very targeted way toward a specific location within the brain.

In a study on 32 individuals, 70 percent of those that received the therapy saw “marked” improvement in their depression symptoms. This is still an early and very limited clinical study, which will help the researchers to optimize their stimulation protocol and better target the disease.

Novel Hemodynamic Monitoring

Stents and blood flow diverters are now a common way to treat brain aneurysms, but whether these therapies actually help specific patients is hard to tell post treatment. Contrast enhanced angiography can do the job, but it is dangerous, inconvenient, and unpleasant to perform frequently. Researchers at Georgia Tech developed a sensor that can be built into currently available neural stents and flow diverters that can provide live hemodynamic information precisely from the spot that was treated.

The flexible sensor is a wireless device that can be printed to match the implant it will is attached to. As blood flows through the device, its capacitance slightly changes and this effect can be used to monitor blood flow perturbations down to .05 meters per second. It relies on inductive coupling to transmit its readings wirelessly to another device positioned outside the body.

Following transradial percutaneous coronary interventions (PCI), the radial artery can occasionally occlude, potentially resulting in serious complications. Radial occlusion is treated by applying compression, but clinicians have no idea whether nor how much blood is flowing through the artery. Moreover, once an occlusion happens in the radial artery, it cannot be used again as an access site.

A new wireless device called IdaFlo Tr from IdaHealth, a company out of Bonita Springs, Florida, is placed around the wrist of a patient, near the access site to continuously monitor blood flow through the radial artery. It can sound an alarm if it detects a slow down in flow. So far tested on a small group of patients, it was able to spot abnormal blood flow post coronary catheterization. This allowed clinicians to intelligently adjust the compression device that was used, closing the access site and preventing any occlusions.

Researchers at Stanford University have developed a biodegradable blood flow sensor that can be wrapped around an artery during vascular surgery, and then monitor blood flow thereafter. The battery- and wire-free device can let a clinician know if a vessel is blocked, helping to address complications after surgeries. As the sensor is biodegradable, it does not need to be surgically removed later, and simply breaks down and disappears.

The pulsing vessel distorts the inner surface of the sensor, which changes its ability to store an electrical charge. This property can be measured wirelessly by a device outside the body, which can connect to the antennae of the sensor, providing a wireless blood flow measurement for clinicians. In the future, the researchers hope that the external measurement device could be incorporated into a wearable or smartphone.

Laser Ultrasound Contact-Free Imaging

Optoacoustic imaging involves using a laser to induce sound waves within tissues and to pick up the ultrasonic reflections using a traditional detector that makes contact with the skin. MIT researchers were able to use another laser to do the detecting, resulting in an ultrasound system that uses nothing but lasers to look deep inside the body. This is a major development, and such technology may revolutionize the field of ultrasound. Since with conventional ultrasounds skin contact severely modulates the resulting signal, a contact-free approach may overcome that limitation entirely. The researchers have already tested their system with healthy volunteers, scanning their forearms from a half meter away and comparing those results with those of conventional ultrasound. They were able to observe as deep as 6 centimeters into tissues and could see muscles, fat, and bones, reporting that their results were comparable with standard ultrasound.

Of note, researchers in 2019 also used contact-free ultrasound to image giant pregnant manta rays!

Wireless Implant Controls Overactive Bladder Using Light

Collaborators from Washington University in St. Louis, the University of Illinois at Urbana-Champaign, and Northwestern University created a flexible wireless implant that senses the movements of an overactive bladder and delivers light to bring it under control.

Electrical sacral nerve stimulation for overactive bladder has been around for decades, but instead of having electrodes, the new device sports LEDs that can shine light on the nerve. A virus is used to deliver opsin proteins, which are sensitive to light, into the nerve cells in the bladder. The implant is in the shape of a belt, which is wrapped around the bladder, and which can sense the bladder as it expands and contracts. The device uses Bluetooth wireless connectivity to relay its readings to an external computer, which can identify when the bladder needs to be stimulated and tell the implant to turn on its LEDs.

While the implant is impressive, and has already shown to be effective in lab rats, the overall technology still requires the delivery of proteins using viruses, the safety of which will require years of pre-clinical and clinical trials. Nevertheless, having a working, proof-of-concept model of the entire therapeutic system will go a long way to helping bring all this to reality.

Growing New Bones Inside Patients’ Bodies
A team from Rice University printed a 3D bioreactor moldwithin which new bone can grow. It is made to be attachable to the rib bones of patients and can support stem cells and the formation of blood vasculature. The mold can be custom-made to the patient’s own needs and after a few month of growth, the bioreactor can be explanted and the bone within transplanted to another part of the body.

This was already tried in sheep and the bones transferred successfully to treat a large injury in the mandible of the animals. The therapy successfully worked in five of the six animals studied and points the way for similar attempts in humans. This will be of particular interest in craniofacial surgery, ENT, neurosurgery, and other fields where small bones are of much needed use.

Fully Implanted Artificial Heart

Until this year, implantable heart pumps had to be powered by external devicesto keep working. This creates potential for infections, difficulty dressing and taking showers, and a whole variety of other problems.

Leviticus Cardio, a company based in Israel, and Jarvik Heart, the famous maker of artificial hearts, have announced that a man in Kazakhstan became the first person in the world to receive a completely implanted ventricular assist device (VAD). The gentleman received a Jarvik 2000 VAD, which was powered by Leviticus Cardio’s Coplanar Energy Transfer (CET) system.

The Leviticus CET consists of an coil ring that is implanted around the lungs and attached to the chest wall, an internal battery and controller, and bra-like device that transmits energy to the coil ring, an external battery and controller, and a smartwatch to monitor the status of the system. There’s also a tablet computer that is used to program the system during the setup process.

The system is designed to work with all currently available VAD devices, as it supplies up to 30 Watts of continuous power. The system can be used even while the patient is walking and moving around, as the supplied electro-magnetic inductance can cover a large effective area encompassing the whole of the coil ring.

Mechanical Pill Attaches to Stomach to Deliver Insulin

Unlike many other drugs, insulin, being a protein, cannot be easily put into the form of a conventional pill. Inhaled insulin (afrezza) is an option that is appropriate for some patients, but it hasn’t caught on very well. A team of researchers from MIT, Harvard, and Novo Nordisk, the world leader in insulin production, have now developed a pill that reliably attaches itself to the walls of the stomach to automatically inject insulin into the bloodstream.

The pill, which has already been tested on pigs, features a mechanism that makes sure that after swallowing, its injection needle is positioned against the wall of the stomach. The needle is protruded to hold onto the stomach and to access the blood vasculature within the stomach. Insulin is then pushed through to deliver therapy, all without the patient having to do more than simply swallow the pill.

Once the insulin is released, the amount of which can be customized for different patients, the pill detaches from the stomach and leaves the body along with the rest of the excrement. The pill consists of a biodegradable polymer and small steel parts, so there’s little fear of side effects from the pill itself. While it has been developed for insulin delivery, the pill may also end up being effective for delivering other protein-based drugs.

And that’s that for 2019 and for the decade it was part of. We very much look forward to the coming years and to the exciting and unexpected medical technologies that will surely be developed by bright minds around the world.

We wish you, our readers, the best in your ventures. Join us again in 2020 to keep tabs on everything exciting in medtech.