Balloon kyphoplasty
A broken vertebra can be inflated and cemented
Mediatoma, a Russian startup, has registered an innovative medical instrument for balloon kyphoplasty, a minimally invasive spinal surgery for a compression fracture, with Roszdravnadzor.
In Russia, about 40 thousand such injuries occur annually. "With a compression fracture, the vertebra loses its shape and subsides. There is a gross deformation of the vertebral column. In fact, a person becomes hunchbacked. Especially often such fractures occur in the elderly, which is associated with age–related bone fragility - osteoporosis. In young people, a compression fracture of the spine happens as a result of injury," explains Dmitry Dorokhov, CEO of Mediatoma (a resident of Skolkovo), who developed an innovative tool.
A person with such an injury had to lie in bed, swallow painkillers and wait for everything to heal, and then wear an orthopedic corset for the rest of his life. But two minimally invasive methods of treatment of compression fractures appeared: vertebroplasty (invented in 1984 in France) and balloon kyphoplasty (developed by the American company Kyphon and approved in the USA in 1998). In addition to the low invasiveness, these methods have one more property in common: in both cases, the so–called bone cement is injected into the damaged vertebra - a medical solution based on polymethylmethacrylate, which after a few minutes becomes as strong as granite.
The difference is that vertebroplasty is, in fact, the strengthening of a deformed or collapsing vertebra. "During vertebroplasty, a tube is inserted through the back into the center of the vertebra and bone cement is pressed through it, which strengthens the vertebra from the inside," says Dmitry Dorokhov.– The vertebra ceases to collapse, but its shape does not recover – this is the main drawback of the technique. As a result, the patient may have pain, limited movement, poor mobility. Balloon kyphoplasty is a step forward. The indications for the operation are the same, but its task is to restore the original anatomical shape of the vertebra as much as possible and only then strengthen, "cement". This is due to an additional part of the instrument – a special balloon placed at the end of the catheter. "
How does it work? "As with vertebroplasty, a small tube in the form of a needle with a diameter of 4 to 5 mm is inserted percutaneously into the patient's spine on the operating table, only in the case of balloon kyphoplasty, a balloon catheter is also inserted into it, which is a thin plastic tube at the end of which there is a deflated balloon balloon, only with very strong walls,– Dmitry Dorokhov tells.– An inflator piston filled with radiopaque liquid, safe for humans, is screwed to the balloon catheter. The piston moves, and the liquid is fed into the balloon, which straightens under pressure in the vertebra and, like a jack, begins to restore the anatomical shape of the vertebra, forming a cavity inside it. After the balloon has straightened the vertebra, the liquid is pumped out of the balloon, and the balloon is deflated. The balloon catheter is removed from the tube, which still remains in the vertebra. Bone cement is injected through the tube, and it fills the cavity. The doctor monitors the course of the operation using X-rays or computed tomography and sees in real time whether the vertebra has recovered sufficiently and when it is possible to deflate the balloon and proceed with the introduction of cement."
The operation is performed under local or intravenous anesthesia. Surgical intervention lasts from 30 to 50 minutes on one vertebra, and two hours after the operation, the patient can already walk. On the same or the next day, the patient is discharged from the hospital, and after three to five days he can start work.
This is balloon kyphoplasty in general terms. Mediatoma's achievement is that it has created an innovative tool for an existing methodology. "We had an idea to make the balloon manageable," the CEO of the startup emphasizes.– There is a window on our tube through which the balloon opens, and the lower part of the tube serves as a fulcrum. The balloon rests on the tube and straightens the vertebra more effectively. In the traditional method, the balloon opens in all directions at once, since it completely goes beyond the tube and has no fulcrum, since the structure of the vertebral bone is porous and the balloon can simply follow the path of least resistance, and not in the direction we need. And this can affect the outcome of the operation and the fate of the patient. Our goal is to minimize the risks of complications, to make the whole process controlled by the surgeon. We patented the idea of a tube with a window in Russia, and a few years later we implemented and registered it."
The invention of Mediatom and its registration open up new opportunities for residents of Russia who have received a compression fracture. "Vertebroplasty is still popular in Russia, and all because of its cheapness," Dmitry Dorokhov complains.– It fits well into the quota for high-tech medical care. Hospitals cannot afford a balloon kyphoplasty tool: imported costs $2-3 thousand, and the medical quota was only 130 thousand rubles, but now it has been increased to 180 thousand, which will help promote new technologies. Our tool in full configuration with cement will cost 80-90 thousand rubles."
The first operation with an innovative tool has already been carried out – the chief scientific ideologist of the project, director of medicine and Science of Mediatoma, neurosurgeon, candidate of medical sciences Alexander Toma operated on three vertebrae of the patient (his name is not called). The operation was performed normally, without complications. But it will not be possible to widely introduce an innovative tool and a progressive method of balloon kyphoplasty in Russia quickly. It's all about money. "The operation is not easy, it requires training of doctors," Dmitry Dorokhov is sure.– Just selling 30 sets to some clinic is wrong from the point of view of patient care. We must first prepare doctors. Surgeons need to demonstrate how to use our instrument in a real situation, conduct trainings and provide flawlessly verified instructions for the operation. We already have preliminary agreements with several large medical centers, on the basis of which we will be able to gather doctors and conduct the first demonstration operations, but for this it is necessary to attract additional funding. While balloon kyphoplasty is unpopular in Russia, but we will try to change this situation. Russia needs the best medicine."
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