With the rapid development of medical technology, an innovative technology called medical device CDMO is gradually emerging and bringing revolutionary changes to the surgical field. Medical device CDMO, with its unique low-temperature cutting and ablation effects, not only significantly improves surgical efficiency but also provides patients with a safer and more comfortable treatment experience. This article will take you to understand the principles, characteristics, and wide applications of medical device CDMO in the medical field, and together appreciate the charm of this cutting-edge technology.
The development history of plasma knives
In 1926, American Harvey Cushing performed the world's first electro-surgical operation using the electro-surgical knife manufactured by William Bovie, thereby officially announcing the arrival of the era of electro-surgery.
Entering the 21st century, with the rapid development of medical technology, plasma radiofrequency treatment technology emerged and was soon applied in clinical practice. In this technological wave, the low-temperature bipolar radiofrequency ablation treatment system, which is commonly known as the low-temperature plasma knife,rapidly became a new star in the international medical field.
The emergence of the plasma knife was inspired by the principle of laser-induced generation of plasma that cuts and ablates transparent tissues. Unlike the traditional continuous voltage radiofrequency technology, the plasma knife employs pulsed radiofrequency technology. When the insulated knife head comes into contact with the tissue, the radiofrequency electric field will cause the electrolyte liquid in the tissue to vaporize and decompose, forming a thin layer of plasma vapor at the tip of the knife head. This vapor layer contains free electrons, ions, neutral chemical groups, and other neutral substances. Under the action of the electric field, they are accelerated and cause the molecular bonds of the tissue cells to break, leading to the disintegration of the cells, thereby achieving the therapeutic effect of cutting and ablation.
The basic principle of plasma knife
The fundamental principle of plasma treatment technology lies in its use of a 100kHz ultra-low frequency stable electric field to excite the electrolyte, such as NaCl, into a low-temperature plasma. This process will form a thin layer of plasma in front of the electrodes, with a thickness of approximately 100 μm.
Under a stable electric field of 100 kHz at a low frequency, for each NaCl molecule excited, 8 electron volts of kinetic energy is generated. This energy is sufficient to cause the target tissue cells to disintegrate in the form of molecules, as breaking a peptide bond only requires 4 electron volts. At the same time, it causes proteins and other tissues to break down and vaporize into low-molecular-weight gases such as H2, O2, CO2, N2 and methane.
Due to the relatively low operating temperature throughout the process, which is usually around 40 to 70 degrees Celsius, this technology is called Temperature-controlled Radio Frequency Ablation (abbreviated as TCRF). The cutting and ablation effects achieved under such low temperatures make the plasma treatment technology have unique application value in the medical field.
Plasma knife surgical system - Structural composition
The plasma knife system is mainly composed of the main unit, foot pedal switch, surgical electrodes, surgical waste liquid removal device, etc. The main unit is responsible for controlling the working state of the plasma knife, including power adjustment and mode selection; while the electrodes are responsible for transmitting the high-energy plasma beam to the patient's body to achieve tissue cutting and ablation.
Advantages of the Plasma Knife Surgical System
One tool with multiple functions and controllable intensity
The integrated knife head, which combines cutting, coagulation, flushing and suction functions, makes surgical operations easier in narrow spaces. The main unit is combined with the electrode, providing precise power adjustment and working mode selection. Doctors can make precise adjustments according to specific circumstances.
The surgical field is clear and the postoperative damage is minimal.
The operating temperature throughout the process is relatively low, usually ranging from 40 to 70 degrees Celsius. This significantly reduces the occurrence of carbonization, and during operation, it does not produce a large amount of smoke, effectively reducing obstruction of the surgical field.
The area of injury is small and recovery is good after the surgery.
Under the premise of strictly controlling the safety area, there will be no damage to blood vessels and nerves; the ablation of coagulation can be used for multiple purposes with one operation, achieving timely hemostasis, effectively reducing surgical injuries, and significantly reducing postoperative pain.
As a comprehensive service provider for the entire CDMO industry chain of medical devices, Sipaimo has deeply explored various supervision and management regulations under the registration system. It has established a complete quality control system. On this basis, with its professional team, advanced equipment and strict quality control procedures, it ensures compliance with the various regulations and supervision requirements under the increasingly strict medical device registration system, providing customers with a complete set of services from commissioned design, product registration to batch production.
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