industry news

A team of researchers has developed a soft robot that could help medical implants such as pacemakers, breast implants, neural probes and drug delivery devices adapt to the body.

The team involved the National University of Ireland Galway (NUI Galway), Massachusetts Institute of Technology (MIT) and AMBER at the SFI Research Centre for Advanced Materials and BioEngineering Research.

Usually, the body delivers protection responses towards implanted devices. These body responses affect the function, performance and therapeutic efficacy of the implants.

One of the body responses is fibrosis, which involves the formation of a dense fibrous capsule around the implanted device. The fibrous capsule can hinder the device’s function or lead to its failure.

Failure rates due to fibrosis can range from 30% to 50% in case of implantable pacemakers, and 30% for mammoplasty prosthetics.

Named dynamic soft reservoir (DSR), the new soft robotic device is designed to significantly decrease fibrous capsule build-up by modifying the environment at the interface of the implant and the body.

The device leverages mechanical oscillation to manipulate the response of cells around the implant. According to the researchers, the soft robot can change its shape at microscopic scale via an actuating membrane.

NUI Galway anatomy professor Garry Duffy said: “We feel the ideas described in this paper could transform future medical devices and how they interact with the body.

“We are very excited to develop this technology further and to partner with people interested in the potential of soft robotics to better integrate devices for longer use and superior patient outcomes. It’s fantastic to build and continue the collaboration with the Dolan and Roche labs, and to develop a trans-Atlantic network of soft roboticists.”

The research has been published in the Science Robotics journal.

Engineers at Massachusetts Institute of Technology (MIT) have developed a magnetically steerable robotic thread which could be paired with existing endovascular technologies to treat blockages and lesions in the brain.

To clear blood clots in the brain, doctors often perform an endovascular procedure, whereby a thin wire is inserted into a patient’s body through a main artery in the leg or groin. The wire is then manually rotated up into the damaged brain vessel, guided by a fluoroscope, and delivers drugs or clot-retrieval devices to the affected region via a catheter.

The procedure is physically taxing and requires specially trained surgeons who must endure repeated radiation exposure from the fluoroscope. The robotic thread developed by the MIT team could help to bypass some of these obstacles.

The research team coated the wire’s core in a rubbery paste embedded with magnetic particles. These particles can be activated by a large magnet and guided around the body. The magnetically steerable device does away with the need for surgeons to physically push a wire through a patient’s blood vessels, meaning doctors wouldn’t need to be in close proximity to the patient or the radiation-generating fluoroscope.

The hydrogel-coated thread has been magnetically guided through a life-size silicone replica of the brain’s blood vessels. The core of the robotic thread is made from a nickel-titanium alloy which is bendy and springy, giving it the flexibility to wind through taught blood vessels, while the hydrogel gives it the necessary slippery coating to guide through tight spaces.

Blockages in the brain are common in stroke patients. Stroke is the fifth leading cause of death and a leading cause of disability in the US, but if treated within the first 90 minutes, survival rates increase significantly. The researchers hope their work can help aid the development of magnetically-assisted endovascular surgeries to help treat these patients.

MIT associate professor of mechanical engineering Xuanhe Zhao said: “If we could design a device to reverse blood vessel blockage within this ‘golden hour,’ we could potentially avoid permanent brain damage. That’s our hope.”

The US Food and Drug Administration (FDA) has recommended devicemakers and healthcare facilities use duodenoscopes with disposable endcaps or fully disposable versions when they become available, in order to avoid patient infection.

Duodenoscopes are flexible, lighted tubes that are placed via the mouth, throat and stomach into the top of the small intestine, called the duodenum, to detect and treat problems in the pancreas and bile ducts.

Commonly, the devices come with reusable components that are difficult to clean. Reprocessing of duodenoscopes involves numerous steps and incorrect reprocess could lead to disease transmission.

Postmarket surveillance studies revealed that healthcare facilities fail to follow many steps in reprocessing instructions.

Duodenoscopes with a fixed endcap come with a permanently attached plastic or rubber cap, which impacts the cleaning of the crevices at the distal end.

The FDA has said that disposable versions could enable simple or no reprocessing, mitigating contamination risk compared to reusable or fixed endcaps.

FDA Center for Devices and Radiological Health director Jeff Shuren said: “We recognise that a full transition away from conventional duodenoscopes to innovative models will take time and immediate transition is not possible for all health care facilities due to cost and market availability.

“This is why we’re communicating with health care facilities now-so they can begin developing a transition plan to replace conventional duodenoscopes and those facilities that are purchasing duodenoscopes with fixed endcaps can invest in the newer, innovative models.”

Shuren added that the risk of infection due to poor reprocessing of duodenoscopes is relatively low but the latest move is based on continuing increased contamination levels in devices.

The FDA recommended healthcare facilities to transition away from the fixed endcap models of Olympus Corporation, Fujifilm Medical Systems USA and Pentax Medical.

The FDA also called for new postmarket surveillance studies on duodenoscopes with disposable endcaps. Additionally, it has asked for duodenoscope labels to include real-world contamination rates.

UK-based online therapy provider Ieso Digital Health has applied deep learning to provide new insights into which aspects of psychotherapy are the most effective.

Using data from 90,000 hours of its internet-enabled cognitive behavioural therapy (ie-CBT) transcripts, Ieso has trained a deep learning AI to recognise the content of language used by therapists during CBT sessions.

Ieso Digital Health senior scientist Michael Ewbank said: “With our deep learning model, we can extract knowledge accumulated across thousands of hours of CBT in a way that would be impossible for a human to do.”

During ie-CBT, the patient and practitioner communicate using a real-time text-based system, allowing the conversations to be captured as transcripts.

The records of over 14,000 patients aged 18 to 94 undergoing ie-CBT were analysed. This collective of patients had a reliable improvement rate of 63.4% and an engagement rate of 87.3%.

The researchers identified 24 therapy feature categories, such as greetings, mood checking and setting goals. The mean number of words for each feature, averaged across all sessions, was calculated for each case.

The researchers found that when therapists focused on CBT behaviour change methods, patients were more likely to show an improvement in their symptoms and engagement with the therapy.

Conversely, patients were less likely to improve when sessions had an increased quantity of ‘non-therapy’ content, such as small talk. They would also be more likely to disengage from their treatment.

The study has been published in JAMA Psychiatry.

The findings support the key principles underlying CBT and provide validation for CBT as a treatment. Unlike other medical treatments, psychotherapy is comprised of a series of one-to-one discussions, meaning systematically measuring the efficacy of treatment is difficult.

Ewbank said: “What is exciting about this study is that it demonstrates the potential of Ieso’s data set, where we can understand more about what the active ingredients of therapy are, what works for whom, and develop new and more effective treatments for mental health disorders. Our work represents a first step towards a practicable approach for quality-controlled behavioural health care with the goal of improving the efficacy of psychotherapy.”

A simple and inexpensive smartphone device developed by University of Arizona researchers could be used to help detect norovirus in high-risk everyday settings.

Norovirus causes 20 million cases of food poisoning in the US each year and leads to 200,000 deaths worldwide. Equipment to detect the disease is typically confined to a laboratory setting, but as it is highly infectious and can cause illness with just ten particles, laboratory results confirming the presence of the virus can often come too late.

This new device could enable the detection of the disease on the ground in norovirus risk areas like cruise ships or municipal water wells, before the infection has a chance to spread.

Researchers used paper, in the form of microfluidic chips, to build the device. Paper substrate is very cheap and easy to store, meaning the diagnostic microfluidic chips are easy to produce. The fibrous structure of the paper also allows liquid to flow easily without using a pumping system, which can be required with chips made out of materials like silicone.

Potentially infected water is added to one end of the paper chip, with tiny, fluorescent polystyrene beads added to the other. The beads are coated in a norovirus antibody, and clump together around virus particles if the disease is present.

The clumps are large enough for a smartphone microscope to detect and photograph.

University of Arizona biomedical engineering researcher Jeong-Yeol Yoon said: “Norovirus particles are too small to be imaged by a smartphone microscope, and so are antibodies. But when you have two or three or more of these beads joined together, that indicates that the norovirus is there, causing the beads to aggregate.”

Once the photograph is taken, an app created by the researchers counts the number of illuminated pixels to identify the number of aggregated beads, and subsequently the number of norovirus particles in the sample. The capillary action of the paper allows the beads to spread out across it, making them easy to count.

Yoon said: “You don’t have to be a scientist or an engineer to run the device. Analysis will be done automatically by the smartphone app, so all you have to worry about is loading a sample of water on to the chip.”

Microfluidic chips and a smartphone microscope could theoretically be given to public health workers to monitor water supplies for the spread of norovirus. The research team now hopes to build upon their technology to allow the detection of norovirus at even lower levels. They also hope to see the device modified to detect other hazardous water-borne substances such as carcinogens.

UK-based financial scheme Medtech Accelerator has provided a total of £150,000 funding for new medical projects on critical care logistics and cornea replacement surgery.

The company was formed in 2016 and is a joint venture led by Health Enterprise East. It aims to support the development of new medical technologies.

The latest awards will help to create a cloud-based software platform called LocANTS, which is intended to facilitate the sharing of critical, real-time information when moving a patient between hospital sites.

LocANTS will use monitors and smart devices so that the transfer team can identify available resources such as clinical parameters, beds and traffic conditions.

The software is expected to allow effective decisions, while decreasing transfer time and efficiency.

Funding from the Medtech Accelerator award will support LocANTS’ early development and testing in the Acute Neonatal Transfer Service (ANTS) for the East of England.

Furthermore, funding will go towards the development of Corneal Graft Suturing Ring (CGSR) device, which is intended to enable better suturing and prevent common complications related to corneal graft surgeries.

Corneal graft surgeries are performed to replace damaged cornea with healthy donor tissue. However, handling of these grafts is difficult and can affect the suturing.

Inadequate suturing could impact a patient’s visual outcome and is associated with other complications such as the risk of wound leakage.

The CGSR device aims to bypass these complications by supplying a means of keeping the donor graft in position and alleviating the suturing process.

Medtech Accelerator investment committee chair Dr Paul Seabright said: “Critical patient transfer data and corneal replacement surgery represent very diverse and unrelated areas of healthcare.

“However, all our projects are inextricably linked by the potential to radically transform patient care through innovation. We look forward to working with the teams at both LocANTS and CGSR to help bring their technologies to our hospitals.”

To date, Medtech Accelerator has aided 13 projects with total awards of more than £1.15m.

Researchers in Australia have unveiled a new hand-held device that examines saliva for biomarkers of heart disease and warns the user via an app, allowing preventative interventions.

The portable, diagnostic stick has nano-sensors at its tip to measure the biomarkers. It is designed to predict the risk of heart disease, failure or heart attack.

RMIT University researchers have partnered with the Innovative Manufacturing Cooperative Research Centre (IMCRC) to further research and develop the diagnostic for pilot manufacture.

They expect to work with start-up ESN Cleer to make the device commercially available by 2021.

ESN Cleer CEO Leopoldt de Bruin said: “Of the 400 million people who suffer from cardiovascular disease globally, only 16% of cases are due to genetic traits.

“This underlines how much room there is to improve on screening and prevention, which is where this device could have such an impact.”

The new device is backed by a sensing technology developed by the university’s Micro Nano Research Facility team. The technology was found to measure biomarker concentrations far more accurately than levels in body fluids.

RMIT University Functional Materials and Microsystems Research Group research co-director Sharath Sriram said: “Often, blood tests are only conducted after a heart failure episode. Such reactive testing is too late, leaving people with a debilitating illness or leading to deaths.”

“Prevention is always better than cure, which is where this technology comes in, adding accurate prediction to the mix.”

Funding from the IMCRC will provide $3.5m to support the manufacture and large-scale production of the diagnostic swabs, which are expected to cost a competitive price.

The researchers noted that user insights are being considered during the design process. Furthermore, machine learning algorithms will analyse results from the device to improve accuracy over time.

Moreover, the application of the diagnostic device is anticipated to expand for predicting cancer risk.

Abbott’s blood test can detect the presence of a mild traumatic brain injury (TBI) even when a computed tomography (CT) scan fails to find it, a study has confirmed.

The test is designed to identify increased levels of a protein called brain-specific glial fibrillary acidic protein (GFAP) in the blood. Abbott’s i-STAT Alinity blood analyser device was used to carry out the test.

A CT scan is the existing standard of care for acute detection of blood or swelling in the brain.

The study, named TRACK-TBI, showed that approximately 30% of patients who had a normal CT scan exhibited TBI signs when tested with an MRI scan. However, MRIs are not accessible at all hospitals, are comparatively slow at delivering results and are more costly, noted Abbott.

The study analysed 450 patients who were admitted to the emergency department at 18 trauma centres within 24 hours of a suspected TBI and had a negative CT scan.

Investigators used Abbott’s test to detect GFAP levels in the participants’ blood samples and later performed MRI scans up to two weeks to confirm the TBI.

Out of the 90 participants who had the highest GFAP levels, 64% were found to have a TBI with the MRI scan. Also, of the 90 people with the lowest GFAP levels, 8% were found to have a TBI.

Abbott added that GFAP levels were significantly elevated in people with a positive MRI and a negative CT scan than those with both negative scans.

The biomarker is also expected to enable prediction of the type of damage and its extent.

Meanwhile, GFAP levels were not significantly high in healthy participants or those with only orthopaedic injuries.

From the findings, the company have said that GFAP can be used as a biomarker to identify those who need further tests to confirm TBI.

Abbott Diagnostics neurologist and medical director Beth McQuiston said: “Healthcare providers rely on blood tests for a variety of conditions because of their accuracy and speed, yet we haven’t had a blood test for the brain as part of the standard of care.

“Abbott’s i-STAT device has become a trusted brand in hospitals globally today. In the future, our TBI test and next-generation device could also be added to the standard of care, working together with CT scans and other diagnostic tools to provide doctors with a more complete understanding of a patient’s condition.”

The TRACK-TBI study also assessed the link between brain injury and S100 calcium-binding protein B (S100B), ubiquitin C-terminal hydrolase L1 (UCH-L1) and neuron-specific enolase (NSE) protein.

Higher GFAP levels were observed to be more sensitive for identifying brain injury in case of a negative CT scan compared to higher levels of UCH-L1, S100B or NSE.