Nano-pulse turned into a sharp blade for minimally invasive treatment of tumors with a new weapon
The clinicians put forward requirements and participate in the design, the medical engineering department of the hospital sets product standards, the medical device research institute conducts electrical safety electromagnetic radiation testing, and the hospital completes clinical verification and promotes the application... The specialized division of the joint team is the research and development of equipment The application has built a one-stop transformation platform for the interlocking medical equipment industry technology.
"On the evening of July 20, I rushed to the hospital in the rain and asked the team members to move a special instrument to a higher floor." On September 22, Director Gang Dong of the Ultrasound Intervention Department of the First Affiliated Hospital of Zhengzhou University told reporters Recalling, "The development of nanosecond knife equipment is not easy. It is the painstaking effort of Chen Xinhua's team at Zhejiang University. It carries the hope of many liver cancer patients."
"Under the background of the new crown pneumonia epidemic, the torrential rain in July was another test for the clinical application of the nanosecond knife." Chen Xinhua used to smile indifferently.
Since returning from studying in the United States in 2011, he brought the returned team to found Hangzhou Ruidi Biotechnology Co., Ltd. (hereinafter referred to as Ruidi Bio) in 2014, from entering Zhejiang Haichuang Park incubator to develop equipment, and obtaining AIDS and viral hepatitis in 2018 With the support of major national science and technology projects for the prevention and treatment of major infectious diseases, 120 cases of clinical operations in the restricted area of liver cancer thermal ablation have been safely completed, and the nanosecond knife, a domestically-made liver cancer precision minimally invasive ablation device with independent intellectual property rights, has been gradually completed and the solution for clinical use ...
Chen Xinhua, who has a lot of energy, tried to replace imported microsecond pulse electric field ablation equipment with domestic equipment, and took the lead in the next generation of pulse electric field "no man's land"-the original nanosecond 10 thousand volt high-voltage steep pulse equipment Innovation.
"The recent results are good, and it is recommended to complete standardized clinical trials that meet the registration requirements as soon as possible..." Not long ago, the major national science and technology project undertaken by Chen Xinhua was passed by the evaluation experts of the Ministry of Science and Technology after comprehensive performance evaluation.
"Wrote" a whole wall patent certificate after three years of retreat
The latest global cancer burden data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020 shows that in 2020, my country’s liver cancer has 410,000 new cases and 390,000 deaths, ranking the first in cancer incidence and mortality respectively. Five and second.
Because the early symptoms of liver cancer are not obvious, most of the liver cancer patients in my country are found in the middle and late stages.
Traditional liver cancer treatment methods can be divided into four types: radiotherapy, chemotherapy, surgery, and interventional ablation, but each has its advantages and disadvantages.
The use of high-power pulse technology in the field of minimally invasive treatment of tumors is in the ascendant.
“It’s been more than 10 years since I looked back. After obtaining a doctorate in surgery at Zhejiang University, I worked in the First Affiliated Hospital of Zhejiang University School of Medicine and accumulated clinical experience.” Chen Xinhua said in an interview with a reporter from Science and Technology Daily.
In 2004, at the beginning of the transformation of the advanced technology of pulsed electric field in the United States, Chen Xinhua was invited to the United States to participate in the medical translational research of high-power pulse technology as a minimally invasive precision surgery expert. He served as the head of R&D in the participating units, and then the chairman of the International Society, leading the development of technical standards in this field.
In the past 10 years, new and innovative products of pulsed electric field technology have continued to come out.
For example, the steep pulse therapy device (Nano Knife) in the United States was approved by the US FDA for clinical use and passed the European Union CE certification; in June 2015, the Nano Knife was approved for tumor treatment and used in clinical practice in China.
Beauty is beautiful, not perfect.
At present, the price of an imported nano-knife exceeds 10 million yuan, and the operation cost of hundreds of thousands of yuan for an ablation has also made many patients daunting.
"On a technical level, nanoknives have defects such as difficulty in completely ablating lesions above 4 centimeters (cm), incomplete inactivation of tumor cells due to electric field depressions, and thermal damage around the probe when the current is too high." Chen Xinhua said, we It is hoped to improve the deficiencies of existing ablation treatment equipment and provide breakthrough innovative therapies for ablation of solid tumors in high-risk areas.
Chen Xinhua knows that original research and development cannot be "used". It is necessary to draw a clear line between the source of the ablation technology and concept and the existing plan, and honestly start from the dirty work.
Pointing to more than 70 patent certificates hanging outside the plant, Chen Xinhua introduced to reporters that the company currently has 3,500 square meters of research and development, pilot production plants and aseptic workshops, all of which started with original technology research.
In 2019, Nanosecond Knife obtained a medical device inspection certificate, and in 2020, it obtained clinical trial ethics approvals in 4 tertiary hospitals.
Multi-party collaboration forging a tool for minimally invasive diagnosis and treatment of liver cancer
“New medical devices still have a very complicated way to go from the workshop to the operating table.” Chen Xinhua said that at the beginning of the design, the team required the nanosecond knife to not cause “injury” during the operation, and it would not be close to important blood vessels and liver. The same applies to pancreatic tumors of ducts, bile ducts, gallbladder or pancreatic ducts, and liver tumors.
In addition, the equipment needs to meet the many needs of doctors in tumor treatment and surgical operations, which involve technical applications such as three-dimensional imaging, image fusion, and navigation.
In order to improve the accuracy and effectiveness of the nanosecond knife for ablation of liver tumors, Ruidi Biosciences teamed up with Wu Tongning team of China Academy of Information and Communications Technology, Song Yujun team of University of Science and Technology Beijing, Zhejiang University Yin Shengyong, Bao Jiali and other bio-electromagnetic experts to coordinate research.
"In nanosecond pulse ablation of liver cancer surgery, there are bottlenecks such as difficulty in formulating clinical preoperative plans due to individual patient differences (such as lesion size, location, etc.) and complex intraoperative treatment positioning." Wu Tongning introduced that the team developed a CT based Or the liver segmentation and lesion area positioning system of magnetic resonance images, and the nanosecond knife operation positioning and navigation system based on optical tracking technology, etc., can provide a reasonable reference basis for the formulation of ablation treatment surgical plans.
At the same time, by carrying out the design and synthesis of nano-molecular probes and nano-Chinese medicines with dark-field optical imaging, MRI imaging and CT imaging and other multi-mode imaging functions, Song Yujun’s team successfully synthesized non-toxic side effects or low toxicity to normal cells. Organic-inorganic composite nano-medicine with high lethality to tumor cells and certain immune activation effect.
After careful design, it is different from the nanoknife's method of killing tumor cells with a microsecond pulsed electric field based on the principle of cell membrane electroporation. The nanosecond knife realizes that the nanosecond pulsed electric field relies on a higher density of external electric field energy to penetrate the cell nucleus and cause it in the cell. The piezoelectric effect causes the cell nucleus, nuclear membrane and mitochondria and other organelle membranes to have various tumor apoptosis effects in sequence, which effectively overcomes the muscle twitching and ECG side effects caused by the large current of microsecond pulses.
Chen Xinhua combed the logic of the specialization of the joint team to reporters: clinicians put forward requirements and participate in the design, the hospital medical engineering department sets product standards, the medical device research institute conducts electrical safety electromagnetic radiation testing, and the hospital completes clinical verification and promotion Application... To build a one-stop transformation platform for interlocking medical equipment industry technology.
Completed more than 100 clinical operations during the epidemic
On the evening of June 12, 2020, at Urumqi Airport in Xinjiang, Changlong Airlines flight GJ8667 arrived on time, but the passengers failed to disembark immediately.
In the cabin, the two engineers of Ruidi Biological were very confused.
On the same day, they set off from Hangzhou and planned to rush to the First Affiliated Hospital of Xinjiang Medical University to assist the hospital in performing its first nanosecond operation.
"We first learned from other colleagues that after the flight stopped in Yinchuan, there were suspected cases on the plane." Ruidi bioengineer Wu Bin recalled that in accordance with local epidemic prevention requirements, passengers on that flight had to be isolated for inspection.
Fortunately, the nucleic acid test of the suspected case was negative.
The new crown pneumonia epidemic has not yet drawn an end, and Chen Xinhua can no longer remember how many such episodes occurred during the implementation of the nanosecond knife national multi-center clinical trial.
Even so, since last year, Nanosecond Knife has conducted multi-center clinical trials in the First Hospital of Zhejiang University, the First Affiliated Hospital of Zheng University, the First Affiliated Hospital of Xinjiang Medical University, and Shulan (Hangzhou) Hospital, and more than 120 operations have been performed.
"Break the monopoly of imported expensive equipment Nanoknife, reduce the price of liver cancer ablation surgical equipment, provide minimally invasive treatments for patients who cannot be treated with other surgical treatments, and reduce the financial burden of patients. This is the original intention and mission of the team for many years of research." Chen Xinhua told reporters.
At present, the research team is continuing to promote the clinical application of high-pressure nanosecond pulsed liver tumor ablation surgical treatment instruments, and has established technical standards with independent intellectual property rights and promoted them internationally.
It is worth looking forward to, based on the previous technology, Ruidi Bio has developed a cardiac atrial fibrillation pulsed electric field ablation system and an endoscopic nanosecond pulse system, and has cooperated with the medical team to make breakthroughs in the research of precision diagnosis and treatment instruments for pancreatic cancer. .
"Relying on copycat foreign products can't last long, facing the international frontier and devoting yourself to original research to understand by analogy. The new equipment of the company's multiple product lines has been offline and will soon be dispatched to cooperative testing units." Chen Xinhua said that this topic has also opened up nanoseconds. The treatment idea of combining local knife treatment with systemic treatment will be the focus of the next step of the research of this research group.