The prospect of medical tubing and Do's and don'ts for medical tubing extrusion lines
Medical tubing is a general term for lumen products that connect the inside and outside of the human body, including metal, plastic, rubber and other products of different materials. Appliances and other aspects are used as a channel and are widely used. As a basic medical device consumables, although medical tubings are not high-value products, this seemingly small business, if done professionally, can also be done like chips (ICs) and circuit boards (PCBs). Become a "hidden champion". The value of medical tubings is relatively low, but its demand is more stable, and it is a long-running business.Some market research institutions believe that the market size of China's medical tubing industry will reach 94.34 billion yuan in 2022. On a global scale, the total value of the medical tubing market in 2019 reached US$54.7 billion, with a compound annual growth rate of 9.17% in the past five years. Affected by the stimulus of the new crown epidemic in 2020, the demand for medical tubings has exploded, and the market size has accelerated. It is expected to grow to 100 billion US dollars in 2025.
The increase in the average life expectancy of the global population and the proportion of aging society, the rise in the incidence of diseases, the growing demand for minimally invasive surgery, and the increase in medical investment by various governments are the main driving forces driving the development of the global medical tubing market. With the adjustment of the consumption structure of medicines and equipment in my country, the improvement of medical conditions, the increase in the coverage of medical insurance premiums, and the improvement of residents' ability to pay, the medical tubing industry has developed rapidly, and the market size has reached 52.21 billion yuan in 2017.
The increase in the average life expectancy of the global population and the proportion of aging society, the rise in the incidence of diseases, the growing demand for minimally invasive surgery, and the increase in medical investment by various governments are the main driving forces driving the development of the global medical tubing market. With the adjustment of the consumption structure of medicines and equipment in my country, the improvement of medical conditions, the increase in the coverage of medical insurance premiums, and the improvement of residents' ability to pay, the medical tubing industry has developed rapidly, and the market size has reached 52.21 billion yuan in 2017.
Innovation of medical tubing Materials
The raw materials of medical tubing are mainly medical polymer materials such as medical PVC, silicone, rubber, latex and TPE. Since medical tubing are used in the human body, some medical tubing need to be implanted in the body, so the physical properties, chemical stability, molding possibility and safety of medical polymer materials must meet medical standards to ensure that they do not contain soluble harmful substances. At the same time, biocompatibility and blood compatibility are required to reduce adverse effects after implantation in the human body.
Due to the low cost and ease of processing of PVC raw materials, it is the raw material for most medical tubing. However, the residual vinyl chloride monomer in the material and the DEHP plastizer added in it will pose a health threat to the human body. With the continuous advancement of technology, silicone rubber, TPU and TPE materials are superior to PVC materials due to their non-toxicity, no additive processing, and good biological properties, and gradually become new materials to replace PVC. Material innovation for the catheter industry.
Advances in processing and production technology
Precision extrusion of medical tubings is a comprehensive system engineering. Raw materials, equipment, and processes will affect the quality and output of the final product. Every link in the production process needs to be refined to ensure the quality and output of the final product.
The manufacturing equipment of medical tubing mainly includes single screw extruder, high precision die, vacuum setting cooling water tank, outer diameter measuring instrument, medical traction cutting machine and conveying collection tank, etc. Their precision and function determine to a certain extent. The precision of the catheter. Precision medical tubing is an important medical device in interventional therapy, and the allowable deviation range of its diameter is less than 5%.
In other countries, the development trend of precision catheter is mainly reflected in the high-speed production process, the precision of product size, the complexity of catheter structure and the endless emergence of new materials. Different from ordinary PVC catheters, precision medical tubing are smaller in size and more complex in cross-section, usually requiring multi-lumen, variable diameter, heterosexual lumen, multi-layer co-extrusion, more material choices (PVC, TPU, FEP, PTFE), dimensional accuracy The requirements are higher, and the tolerance is usually 1/1000 of an inch, which is 0.025mm.
At present, many enterprises and R&D institutions in China have begun to study more efficient production methods for precision medical tubing, and some high-end medical tubing manufacturers at home and abroad have begun to try to produce extruded high-precision medical tubing. Precision extrusion of medical tubing has strict requirements on extrusion equipment and processes.
Control System
The ordinary extruder control system only regulates the parameters such as the screw speed, heating ring and die temperature of the extruder, while the precision extrusion of medical tubings requires the control system to control the parameters of the extruder and connect the upstream and downstream equipment. , feeder, die head, cavity air pressure and online measurement equipment, integrate the control system of upstream and downstream equipment, form closed-loop control, quickly collect sample data, synchronize feedback adjustment parameters, optimize process data, and monitor production and processing in real time. At the same time, it helps to analyze process parameters and optimize and guide production and processing.
In addition, it also has the functions of remote control and offline diagnosis. For example, when the outer diameter of the conduit measured by the online measuring system is close to the tolerance value, the control system obtains the data from the online measuring instrument, and automatically adjusts the temperature of the heating zone of the die and the speed of the screw, and the viscosity of the melt decreases as the temperature increases, while the flow The performance is improved, so as to achieve the effect of compensating the outer diameter of the catheter.
Dedicated screw design
The screw and barrel are the core of the extruder and even the extrusion production line. The quality of the screw barrel is directly related to the precision, output and production stability of the product. The selection of the appropriate screw barrel is the key to the precision extrusion production of medical tubing. The production of medical tubing requires fast speed, the line speed can reach 100 m/min, high precision, complex materials, and good plasticization, so there are high requirements for the material and shape design of the screw. The screw design is suitable to adopt the double-foil barrier screw design, plus a specially designed mixing head to improve the plasticizing effect and output stability. For some processing materials that are corrosive, the material tube is usually made of double alloy material, which can have both corrosion resistance and wear resistance.
Servo motor drive
Unlike other extrusion applications, precision medical extrusion is usually driven by servo motors instead of variable frequency motors or DC motors, which can improve drive accuracy and control response time, ultimately improving product accuracy. In addition, according to the requirements of the U.S. Food and Drug Administration (FDA), in the extrusion production of medical tubing, phenomena such as material leakage, water seepage, and oil leakage are absolutely not allowed. The flight has higher requirements.
Extruder Mould
Like the screw barrel, the extrusion die is the key to precision extrusion. The precision extrusion of medical tubing mostly adopts right-angle die. The straight-through die is not used because the right-angle die enables a smaller footprint for the entire extrusion line to get rid of clean room space constraints. The precision extrusion die for medical tubing requires automatic adjustment of flow channel resistance, and the needle valve structure can reduce the impact of axial pressure fluctuations on product size.
In addition, the automatic adjustment of die gap can ensure stable wall thickness tolerance, and the automatic floating mandrel is the guarantee of concentricity tolerance. Like the screw barrel, it has high temperature resistance, wear resistance and corrosion resistance. These properties put forward high requirements on the material of the die.
Other devices
Metering feeding, melt pump, vacuum setting cooling, online measurement, traction cutting are all important links in precision extrusion, which are related to the quality and output of the final product. For example, a high-precision melt pump can improve the melt pressure stability, increase the head pressure, increase the output of the extruder, and ensure the quality of the conduit, so that the screw of the extruder can focus on mixing and melting, and the cost-effectiveness ratio is higher. high.
In view of the fact that most of the medical tubing are soft polymer materials, such as SPVC, TPU, etc., Songhu Machinery Precision medical tubing Extrusion Unit adopts the technology of "precision weak pressure vacuum sizing control + high pressure volume extrusion", and the precision " The "internal pressure ventilation" forming process aids can greatly improve the pipe forming speed and control accuracy level, thereby improving product quality standards for users and bringing significant unit cost savings. The production line can be used to produce various specifications of infusion tubes, hemodialysis tubes, etc., and has been widely used in domestic
New form of medical tubing technology
medical tubings are one of the most common tools in the hands of doctors, such as balloons, sheaths, and delivery systems. These catheters contain a basic underlying technology, that is, the processing of polymer materials, and extrusion processing technology. applications occupy the majority. The polymer material is processed into a simple raw material pipe by an extrusion process, and then undergoes various subsequent assemblies to form the final catheter device. The hardness, tolerance, toughness, etc. represented by the raw material pipe correspond to various performance points of clinical needs. It should be said that a good extrusion process can meet the parameters and performance requirements of almost all medical tubings.
Opportunities and challenges coexist
The growth of the global medical tubing market is mainly driven by the growing demand for minimally invasive surgery, the increase in cardiovascular diseases, diabetes and urinary system diseases, and the development of catheter diagnosis and treatment technology. In China, various interventional therapy techniques using catheters have been popularized in most tertiary hospitals. From a global perspective, we can understand the prospects of medical tubings from the following points.
1、How big is the catheter market?
b.The global catheter market size was estimated at USD 48.4 billion in 2021 and is expected to reach USD 51.4 billion in 2022.
2、What is the catheter market growth?
b.The global catheter market is expected to grow at a compound annual growth rate of 6.5% from 2022 to 2030 to reach USD 85.2 billion by 2030.
3.Which segment accounted for the largest catheter market share?
b.North America dominated the catheters market with a share of 31.94% in 2021. This is attributable to the presence of multi-national manufacturers and sophisticated healthcare infrastructure along with high product awareness levels.
4.What are the factors driving the catheter market?
b.Key factors that are driving the market growth include rising demand for antimicrobial catheters, increasing prevalence of cardiovascular, neurology, and urology disorders, and growing usage of advanced materials in the catheters.
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