New ultrasound scanner might eliminate want for invasive cranial surgical procedures
Elevated intracranial strain,; or pressure within the brain, could cause everlasting harm. There is a vital market for a device that may detect and messure increased strain easily and rapidly with out surgery, says Selbekk. Here he demonstrates the know-how. Credit: Ole Martin Wold
A new invention could also be on the verge of changing a pricey cranial surgical procedure currently being carried out on some visitors accident victims and other patient teams. The ultrasound-primarily based technology has now been granted CE approval for the European market.
“We’re by means of the attention of the needle on this one,” says Tormod Selbekk. Selbekk is Head of Know-how at the spin-off firm Nisonic AS. He is additionally co-inventor of the brand new system, and was previously a analysis scientist in medical expertise and ultrasound at SINTEF, where the concept was born.
“Elevated intracranial strain (ICP) or brain strain, may end up in mind damage and may be caused by either accidents or illness,” he says.
It can be crucial in all cases to detect brain strain will increase as quickly as possible, as a way to make remedy easier and simpler. One treatment possibility may be as straightforward as the timely administration of diuretic drugs.
Ultrasound may change surgery
Mind stress is at the moment measured immediately using a sensor or by way of a drain that is inserted into the patient’s brain tissue by means of a hole the cranium. The process should be carried out in an working theater. It’s expensive, onerous and, not least has a small danger of facet-impact for the affected person.
The brand new ultrasound scanner, referred to as Nisonic P-100, can relieve the burden on hospitals and provide patients extra delicate treatment. It’s outfitted with constructed-in software program that automatically processes the ultrasound photos The gadget makes it attainable for docs quickly to determine whether or not a affected person may be growing harmful will increase in mind strain. The know-how relies on an algorithm that interprets ultrasound pictures of the patient’s optic nerve sheath, which modifications its dimensions in response to will increase in intracranial strain.
A demanding approval course of
Attaining CE marking approval for the Nisonic P-100 technology has been a demanding process, however the know-how has recently been handed by the various control businesses and was given the green gentle.
“We’re all more than happy about this,” says Selbekk. “This last 12 months has been significantly challenging because the EU has just lately amended its CE marking approval legislation for medical gear On prime of this, we have needed to cope with the effects of the COVID-19 pandemic. Despite these points, we’ve succeeded within the area of just over two years in advancing our prototype and attaining approval as medical tools,” he says.
Because of this not only can the know-how now be used in hospitals all through the EU, however it would also be simpler for us to realize entry to large and rising U.S. markets in the future. The marketplace for ICP detection and monitoring equipment is predicted to increase significantly within the years forward. Several studies have estimated a market valued at USD 270 million, with the most important levels of annual growth within the subject of ultrasound detection. Nisonic is thus ideally positioned to benefit from a future progress area.
Doable game changer
Eirik Helseth is a Professor and Head of Neurosurgery at Oslo College Hospital, UllevÃ¥l. He’s principal investigator in a clinical analysis study, during which ultrasound photos of the optic nerve are recorded in patients affected by severe head accidents. The collaboration within the analysis project makes it doable for Nisonic to receive anonymized ultrasound photographs and ICP measurements for the further growth of the strategies..
As a part of a normal procedure, these sufferers have had a sensor surgically inserted into their brains in order to monitor intracranial pressure. The intention of the analysis challenge is to assess whether or not processed ultrasound images of the optic nerve captured by Nisonic’s know-how can provide a dependable measure of brain stress.
Helseth calls the tactic a potential game changer:
“Current technology solely allows us to make dependable measurements of intracranial stress with the assistance of a sensor, or through a drain, that’s inserted into the affected person’s cerebroventricular (brain cavity) system,” says Helseth. “Both methods require admission to a hospital’s neurological division and a surgical procedure with a view to insert the strain sensor or drain. If ultrasound photos of the optic nerve prove to be a dependable method of measuring ICP, this can open opportunities for the method to be utilized not solely in all other hospital departments, but additionally in GP surgeries and ambulances. This shall be fantastic—and a global sensation,” he says.
The extra data, the higher the result
However, Helseth is keen to level out that the tools can never be better than the info offered to the algorithm.
“It is important that the equipment is utilized in many hospitals in order that we are able to receive much more affected person data to work with,” he says. All medical professionals know that such equipment must be tested on a lot of patients before dependable measurement information can be obtained. For instance, there could also be variations in optic nerve sheath structure between women and men, and among totally different age groups.
“That is why the Neurological Division at UllevÃ¥l is assisting Nisonic with its research and knowledge gathering. We have now great religion within the approach and the technology,” says Helseth.
On the lookout for financial partners
Nisonic is now on the lookout for more capital funding and business companions who may help the corporate notice its abroad progress plans.
“If we reach establishing our method for the non-invasive monitoring of ICP, market assessments have indicated that there is significant curiosity amongst clinicians in hospitals in Europe and the U.S., and a excessive financial potential for the expertise,” says Selbekk.
The corporate has succeeded with the event of Nisonic P-a hundred, by collaborating with several Norwegian contributors. These embrace ultrasound scanner suppliers Vitacon AS, which has supplied key help in connection with the CE marking approval course of; Medistim ASA, which focuses on ultrasound imaging linked to cardiac surgical procedure; and Aurotech AS, based in Tydal, which has supplied hardware. The Nisonic P-100 is at massive an entirely Norwegian product.
In use in Stockholm
The first Nisonic system is already on its technique to the Bragée clinic in Stockholm, which is collaborating with the Karolinska institute in clinical analysis. Right here, the gear can be used for analysis into sufferers suffering from power fatigue syndrome (ME).
Swedish researchers are working with a concept that ME sufferers also exhibit elevated intracranial pressure Nisonic’s equipment will be used to measure the diameters of ME patients’ optic nerve sheaths, in addition to these of a control group. Selbekk says that these measurements will then be compared with diameters measured utilizing magnetic resonance imaging (MRI)
This analysis will provide Nisonic with even more patient knowledge, which will additional improve the system’s algorithms.
“The extra affected person information we’ve, the higher the equipment can be. It’s because the method relies on deep studying and neural networks, which are branches of the field of machine learning and artificial intelligence,” he says, adding;
“Our job will probably be much easier now that the equipment is CE accepted. CE marking permits us to seize anonymous data way more rapidly than in the past. We count on to realize even higher results by means of systematic information analysis and coaching of the neural networks.
Explore additional on front page
Llewellyn Padayachy et al, Pulsatile Dynamics of the Optic Nerve Sheath and Intracranial Pressure, Neurosurgery (2016). DOI: 10.1227/NEU.0000000000001200
Llewellyn Padayachy et al, Noninvasive Transorbital Evaluation of the Optic Nerve Sheath in Children: Relationship Between Optic Nerve Sheath Diameter, Deformability Index, and Intracranial Strain, Operative Neurosurgery (2018). DOI: 10.1093/ons/opy231
Chiara Robba et al, Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic evaluation and meta-analysis, Intensive Care Drugs (2018). DOI: 10.1007/s00134-018-5305-7
Journal data:
Citation: New ultrasound scanner might remove want for invasive cranial surgical procedures (2021, August 25) retrieved 20 September 2021 from –
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