Gaoma Research | How much do you know about ventilators? (The full text is long, it is recommended to collect)


Release time:

2023-04-04

I believe that many people have only heard the word "ventilator", but they have not really understood it. In modern clinical medicine, as an effective means of artificially replacing the autonomous ventilation function, the ventilator plays a very important role in the field of modern medicine. s position.

I believe that many people have only heard the word "ventilator", but they have not really understood it. occupy a very important position in the field.

Q1: What is a ventilator?

Ventilator, also known as mechanical ventilation (Ventilation) in medicine, is a kind of device that can change, control or replace human's normal physiological breathing, improve respiratory function, increase lung ventilation, reduce breathing work consumption, and save heart reserve able device.  

The ventilator is mainly composed of turbines, pumps, valves, chips, sensors, etc. The structure is relatively simple, but the requirements are very high. Among them, key components such as turbines, valves, and sensors (flow sensors, humidity sensors, and pressure sensors) are mainly imported.

The ventilator can play an important role in preventing and treating respiratory failure, reducing complications, saving and prolonging the life of patients, and has been widely used in the treatment of COPD (chronic obstructive pulmonary disease) and OSA (obstructive sleep apnea), respiratory failure, anesthesia respiratory management during major surgery, respiratory support therapy and emergency resuscitation, etc.

Q2: How are ventilators classified?

Non-invasive ventilator: It is relatively widely used in clinical applications. For example, when chronic obstructive pulmonary disease is acutely exacerbated and respiratory failure occurs, a non-invasive ventilator can be selected for assisted ventilation to correct the state of respiratory failure of the patient.

Invasive ventilator: Some critically ill patients need to choose endotracheal intubation and connect to an invasive ventilator for respiratory support.

The process of natural breathing is to expand the chest cavity to form a negative pressure, so that the gas enters the lungs; mechanical ventilation is to force the gas greater than the atmospheric pressure into the lungs. ”.

According to different connection ventilation methods, mechanical ventilation can be subdivided into non-invasive mechanical ventilation (Non-Invasive Ventilation, NIV) and invasive mechanical ventilation (Invasive Mechanical Ventilation, IMV). Invasive ventilator.

Among them, non-invasive ventilators generally ventilate through a closed mask, while invasive ventilators need to insert the ventilating tube into the intake pipe.

It sounds like the difference between invasive and non-invasive ventilators is not that big? Indeed, many ventilator models are now compatible with both "invasive" and "non-invasive" modes.

In the ventilator, the core device for pressurization may be a turbine (low-end) or an air compressor (mid-to-high end). Depending on the technology, the price ranges from 150,000 to 500,000 yuan.

Transport ventilator: used for emergency site resuscitation, long-term use in continuous emergency, supportive induction of anesthesia (TIVA total intravenous anesthesia), from pre-hospital first aid to severe transport, suitable for all first aid in emergency centers and hospitals and transport needs, between hospitals and other locations (secondary transport).

Household ventilator: used to relieve snoring, hypoventilation and sleep apnea of patients during sleep, moderate to mild respiratory failure and respiratory insufficiency, so as to achieve the purpose of auxiliary treatment, usually used in home environment, can also be used Medical institutions. Mainly include: household respiratory support equipment, sleep breathing machine, sleep non-invasive ventilator, continuous positive pressure ventilator, bilevel non-invasive ventilator, positive pressure ventilation therapy machine, etc.

Q3: How did the ventilator evolve?

Throughout the history of human medicine, the evolution of ventilators has gone through the following three stages.

1. The establishment stage of artificial ventilation theory (before the ventilator was invented and manufactured)

In 1543, Belgian medical scientist Vesalius verified Galen's experiment with live pig experiments. By establishing an "artificial airway" for pigs, blowing air into the airway can re-expand the collapsed lungs of pigs, thereby maintaining normal breathing of pigs. He left detailed experimental data and became the first person in the world to describe artificial ventilation.
In 1667, the British scientist Robert Hooke (Rober Hooke) used dogs to do animal tracheal intubation experiments, using bellows to inflate positive pressure ventilation, and found that this method could keep the dogs with collapsed lungs alive for more than one hour . He wrote a paper on the feasibility of bellows positive pressure ventilation after endotracheal intubation, which he submitted to the Royal Society.
In 1732, Scottish physician William Tossach successfully rescued a miner who was suffocated by inhaling fire smoke by using mouth-to-mouth breathing. This was the first formally documented artificial respiration in the history of Western medicine.
In 1745, the British physician John Fothee, who combined William Tossa's approach and Robert Hooke's theory, proposed that when artificial respiration was not effective, a bellows could be tried. This is the prototype of positive pressure ventilation. Since then, bellows technology has been vigorously promoted.

2. Negative pressure ventilation stage (the initial stage of the invention and manufacture of the ventilator)

In the early 19th century, the medical community began to explore new, safer and more effective methods of artificial ventilation.
In 1927, Harvard University, ventilator iron lung came out. The working principle of the iron lung is similar to that of a pump. It consists of an airtight metal cover and an electric suction device. During assisted ventilation, the patient puts the body in a metal device (the neck is outside and the neck is closed), and the suction device is activated to create an artificial negative pressure in the bottle, so that more air can be inhaled through the patient's mouth, nose and trachea. In short, it is a box-type extracorporeal negative pressure ventilation device.
The mixed period of positive pressure ventilation and negative pressure ventilation: an opportunity for the return of positive pressure ventilation
In 1948, the modified iron lung was hit by a polio pandemic in the United States, and the iron lung exposed its fatal flaws of difficult airway management, narrow application range, and high patient fatality rate (80%). Engineer Bennett improved the iron lung and combined it with endotracheal intubation for positive pressure ventilation. This measure has effectively improved the function of the ventilator and reduced the fatality rate of polio patients with respiratory failure to 12%.
In 1952, positive pressure ventilation with compressed air bags caused a polio outbreak in Copenhagen, the capital of Denmark. Due to the lack of iron lungs, local doctors were forced to change their thinking, and under the suggestion of anesthesiologist Bjorn Ibsen, they created a method of intermittent positive pressure ventilation with compressed airbags after tracheotomy, which has been clinically proven to effectively reduce the risk of death in patients with respiratory failure. fatality rate. Since then, Denmark and the United States have become the bases for the development of new mechanical ventilation equipment.

3. Positive pressure ventilation stage (after the ventilator is gradually improved)

From the 1950s to the 1980s, various positive pressure ventilation ventilators came out one after another. And the design that introduced the electronic computer into the ventilator appeared.
In 1989, BIPAP was developed and produced by American Wellcome Company. This non-invasive ventilation ventilator is small in size, light in weight, convenient and flexible in operation, and is suitable for out-of-hospital emergency use. It marks a new era of mechanical ventilation.
Since 1989, on the basis of the original positive pressure ventilation ventilator, the computer function has been improved, and the shape of the ventilator has been optimized.

Q4: What is the demand for ventilators, and how to get it?

There are guidelines to follow for how many ventilators a hospital needs to be equipped with. According to the information issued by the Health and Medical Commission, the critical and critical care units should be equipped with ventilators according to this ratio:

Q5: Why is there not so much shortage of ventilators in China?

As mentioned above, the demand for ventilators is positively correlated with the number of critically ill and critically ill patients in the hospital. The departments that need ventilators in the hospital are usually the intensive care unit, respiratory medicine department and some postoperative care units, and the usual use is not large.

Q6: There are so many people making ventilators across borders, is it reliable?

In 2020, Musk also tried to assemble a ventilator with Tesla's auto parts. Among them, the compressed gas device used for the car's shock-absorbing suspension became the core of the "Tesla ventilator".

In addition to Tesla, General Motors, Ford of the United States, Volkswagen of Germany, and Dyson of the United Kingdom have announced that they will switch to ventilator production. This is not enough. The UK has also integrated 28 companies across aerospace, automotive, medical, engineering and other fields to form the "Ventilator Challenge Alliance" to speed up the production of ventilators in the country.

Then you will definitely ask: Why is it built by an automobile company?

That is probably because the manufacturing skills of car companies are already full: a car is composed of thousands (3000) parts, and the manufacturing process requires both high-precision processing and a high-cleanness dust-free workshop. In short, simply discussing the manufacturing process, building a car may be much more difficult than building a ventilator.

However, the problem of ventilators is not only manufacturing, but also debugging, maintenance and many other problems. The ventilator is not just a machine. Because it involves the medical field, it must be installed, calibrated and debugged by professionals. If there is an error, it may affect the use effect.

Q7: Who makes the ventilator? What is the production capacity?

The global ventilator market size is US$1 billion. In 2018, the low-end medical ventilator market was 1.07 billion yuan, and the high-end ventilator market was 1.36 billion yuan. The ventilator industry is a "small circle", and only a few companies in the world are capable of mass-producing ventilators. According to the Global Times report, in the field of invasive ventilators, head ventilator companies such as Hamilton and Drägerwerk have a production capacity of about 1,000 units per month· .

Data source: Dongxing Securities Research Center

Invasive ventilators are usually used to rescue critically ill patients. In this field, Hamilton of Switzerland is the ventilator company with a quarter of the global market share, and has shared more than half of the invasive ventilator market with leading companies such as Germany's Dräger, Sweden's Getinge Group, and Beijing Yi'an.

Data source: 21st Century Business Herald

According to the Ministry of Industry and Information Technology, there are a total of 31 companies in my country with ventilator registration certificates, including 21 invasive ventilator manufacturers, and 8 of their main products (with a weekly production capacity of about 2,200 units) have obtained the European Union's mandatory CE certification. It accounts for about one-fifth of the world's invasive ventilator production capacity.

Source of data: Joint Defense and Control Mechanism of the State Council

Looking back at the cross-border production of ventilators by Tesla, Ford, Dyson and other companies, the reported production capacity of tens of thousands of units is a very exaggerated figure.

Q8: Where is the difficulty in ventilator manufacturing?

Unlike masks that can "explode production capacity", the production and distribution of ventilators need to rely on a complex industrial supply chain. A typical invasive ventilator has more than 1,000 parts, including ventilator components (fans, sensors, valves, etc.), shells, and software chips.

Manufacturing a ventilator requires far longer time to prepare materials, production lines, personnel and approval process than masks. For a professional medical equipment manufacturer, it takes 40 days to produce a ventilator, while it may take 540 days for a cross-border enterprise to start from scratch.

Data source: 21st Century Business Herald

Q9: How to dispose of the used ventilator?

Used ventilators need to be thoroughly disinfected:

The outer surface of the ventilator is thoroughly disinfected with 75% medical alcohol or hydrogen peroxide;
For external circuits such as breathing circuits, it is recommended to use disposable ventilator circuits, which should be disposed of as medical waste after use; for reusable circuits, it is recommended to use chlorine-containing agents for disinfection;
Replace the air inlet filter; the resterilizable filter is sterilized by high temperature and high pressure (132°C high pressure steam for 20min);
Disassemble and disinfect special components such as flow sensors and exhalation valves, and conduct routine performance tests.

Q10: Will the ventilators in the warehouse "expire"?

Ventilators in inventory also need maintenance-"New York Times" reported that in 2021, there will be 2,109 medical equipment in warehouses in the United States that cannot continue to be used due to lack of maintenance. After a maintenance contract expired, a new contract has not yet been negotiated. This maintenance contract is as high as 38 million US dollars.

As for the cause of damage to the ventilator, it has been mentioned that the external battery of the device needs to be replaced, or the hose and other accessories are missing.
 
Q11: Where are the pain points of the ventilator industry?

The gap between the overall technology of the ventilator industry and the international advanced level is at least 20 years. The inspiratory end of the adult ventilator of domestic leading enterprises is still using the "hot wire" flow sensor that has been eliminated by the international mainstream. High-tech models such as constant frequency and high frequency are in the state of "industry blank". According to clinical feedback, domestic models are suitable for patients with low degree of automation in spontaneous breathing, prominent conflicts between human and machine, and a high probability of secondary use. Moreover, the localization degree of the whole machine is low, and the key components: flow sensors, turbine motors, oxygen batteries and other key components rely on international procurement, and are still in a state of being "stuck" by international medical giants.

The domestic market capacity of the ventilator industry in 2019 (calculated at the ex-factory price) is about 12 billion yuan, of which the high-end medical ventilator market is monopolized by German and American industry giants with more than 80% of the market share. The ventilator export of domestic enterprises is in the second-tier position in the world. Before 2020, the export products of the life support system department of domestic leading enterprises are mainly anesthesia machines and ECG monitoring, and the sales volume of the ventilator market is bleak.

The size of the domestic ventilator segment market in 2019 is as follows: Medical adult ventilator 6 billion/year, medical neonatal ventilator 1.5 billion/year, household ventilator about 4 billion/year, which is the main equipment of life support system . Domestic adult ventilatorFirst-line brands in the market such as: Germany Dräger, Germany Maikewei, Medtronic (PB Tyco), Switzerland Hamilton, GE, Philips Respironics. First-line brands in the domestic neonatal ventilator market: Swiss Feiping, German Steffen, and American Kanger Fusheng, etc. The domestic brand in the medical neonatal ventilator market is only shortlisted by Shenzhen Coman, a neonatal non-invasive ventilator NV8, with an approximate sales of 200 million yuan/year or so.

The ventilator technology leads the technical development of anesthesia machines. Only by improving the level of breathing and ventilation technology can the technical level and brand reputation of anesthesia machines be improved. Otherwise, it can only fall into a series of development "vicious circles" such as insufficient product technology innovation, serious homogeneity, and a vicious circle of price competition. Due to technical barriers and restrictions on R&D investment, domestic ventilators have always been in the ranks of low-end products, unable to meet the actual clinical needs of hospitals and achieve sales breakthroughs.

The key core technology is the product design of the ventilator, which involves a high degree of cooperation between the software derived from the breathing algorithm formula and the hardware servo system, to achieve intelligent breathing and ventilation support according to the patient's spontaneous breathing changes. The international advanced respiratory ventilation technology is monopolized in the hands of the Germans.

The second is the supply of key hardware, such as: turbine motors, flow sensors, high-precision air proportional control valves, oxygen batteries and other key components, which can first pass international matching, and later with the expansion of domestic ventilator production scale, The upstream and downstream industrial support related to the production of ventilators can be gradually improved.

Due to the backward technology and insufficient R&D talent reserves of the domestic ventilator industry, it is difficult to rely on its own strength to develop in the short term, and it is difficult to achieve the fundamental technological leap required for rapid development and catching up. Then catch up with the improved technological development path; on the other hand, through the integration of domestic medical, computer software, mechanical and electronic industries, we will make great efforts to jointly tackle key technical problems and overcome the "bottleneck" of technological development.

Q12: What is the development prospect of the ventilator industry at home and abroad?

Under strict restrictions and multi-party cooperation from the authorities, we should not have to worry about the future livelihood of ventilator manufacturers. According to Sullivan's data: COPD (Chronic Obstructive Pulmonary Disease): In 2020, there will be 467 million COPD patients worldwide, and 105 million COPD patients; it is estimated that in 2025, there will be 530 million COPD patients worldwide, and 108 million COPD patients. OSA (Obstructive Sleep Apnea): In 2020, there will be 1.068 billion OSA patients aged 30-69 in the world, and 195 million in China; it is estimated that there will be 1.158 billion OSA patients aged 30-69 in the world in 2025, and OSA patients aged 30-69 in China Patients reached 209 million people.

Due to low domestic awareness and attention, the diagnosis and treatment rate of COPD/OSA is low. According to Sullivan's data, as of 2020, the total number of COPD patients in my country is 105 million, the diagnosis rate is only 26.8%, and the control rate is only 20.2%; the number of patients in the United States is 24 million, the diagnosis rate is as high as 68.3%, and the control rate up to 58.3%. According to the statistics of the Chinese Sleep Research Association, as of 2020, the diagnosis and treatment rate of OSA in China is less than 1%, which is far lower than the 20% diagnosis rate in the United States. With the improvement of domestic medical level and residents' awareness, the domestic potential market is relatively considerable. The domestic ventilator market will achieve a rapid growth of 20-30% in the next 10 years according to the market size of about 12 billion yuan in 2019 in the normal year.

Moreover, the ventilator has the characteristics of long working hours and easy wear and tear. The normal product life cycle is about 5 years, and there will be about 20% replacement every year. As the key equipment in the life support system, the ventilator market is a blue ocean market with stable growth in the future.

In 2020, Hangzhou Beifeng Technology Co., Ltd. launched the key hardware for the localization of ventilators-turbine motors, making outstanding contributions to the export of domestic ventilators.

At the end of 2020, Mindray Medical launched the new product NB350, a non-invasive ventilator for neonates, but the clinical application effect needs to be tested by the market, and there is no news about the development of high-frequency and normal-frequency ventilators for neonates.

In June 2020, Aerospace Changfeng Medical launched a localized model of the German Elisa ventilator: adult ventilator 8250. This model uses the international mainstream "differential pressure" flow sensor, which is a comparison Big progress. However, there is a certain gap between the overall technical level of the whole machine and foreign high-level products, and the automation and protective ventilation mode settings need to be improved urgently.

Ventilator is an important life support equipment in the field of critical care medicine. It is self-evident to the importance of human life and health, and it is the hope of life. China's ventilator industry is currently in a period of rare historical development opportunities, but the road ahead is long and full of thorns. The domestic ventilator industry should realize its shame and be brave, catch up head-on, and continuously strengthen scientific and technological research in order to occupy the commanding heights of international cutting-edge technology and create a benchmark for the ventilator industry. !