On September 29, 2021, according to the National Medical Products Administration, the first domestic medical water knife independently developed by Hydro CareSYS Medical Co., Ltd. (hereinafter referred to as "Hydro") passed "Innovative Medical Device Approval Procedure" was approved for listing!
"CareSYS-jet water knife" is composed of hydrodynamic treatment equipment and a single-use debridement hydrodynamic cutter head. "Hydrodynamic therapy equipment" is composed of the main unit, foot switch, waste liquid bucket, power cord, and grounding wire; "disposable debridement hydrodynamic cutter head" is composed of infusion tube assembly, high pressure tube, waste liquid tube assembly, and pump body And handle components. The two products are used in conjunction and applied to wound debridement (acute and chronic wounds, burns) and soft tissue debridement.
Meet the requirements of precision surgery and preserve normal tissues to the maximum extent
With the extension of life expectancy of Chinese people and the acceleration of China's entry into an aging society, the demand for wound debridement treatment continues to grow. Traditional metal debridement equipment such as sharp debridement scalpels, spatulas, scabs, and high-voltage pulsed lasers are used for debridement. There are disadvantages such as complex wounds, frequent infections, long treatment cycles, patient pain, and high cost. Patients bear the pain of repeated debridement, doctors are faced with a heavy debridement industry, and hospitals bear expensive imported debridement equipment. Under the superimposed effect of various factors, families and society are facing a heavy burden.
Compared with conventional metal sharps debridement therapy, hydrodynamic debridement is characterized by its short procedure, low-damage wound control, precise cutting and separation, efficient removal of bacteria and bacterial biofilm, simultaneous entrainment of waste, and reduction of pollution. , To meet the requirements of precision surgery, reduce the difficulty of surgery, preserve the normal tissue of the wound to the maximum extent, and promote the rapid healing of the wound.
In the past, domestic medical waterjets were monopolized by foreign brands. Through continuous innovation and continuous overcoming of technical problems, national enterprises finally achieved breakthroughs in medical waterjets. The "CareSYS-jet water knife" project lasted for 8 years. From the establishment of the project to the approval of innovative medical devices, there were many difficulties in the middle. After countless sleepless nights, many technical researches were carried out, including the use of patented technology to achieve continuous fine water flow. Control, the pressure is controlled within a higher precision range; two different structures of cutter heads are designed to realize efficient and fine cutting respectively to meet different clinical needs, etc. This is the first domestic medical water knife The final landing.
Breaking through the technical bottleneck, a number of technologies have reached the international leading position
The medical equipment industry is a strategic emerging industry related to human life and health, and it is also a multidisciplinary knowledge-intensive industry. The "China Water Core" chip, pump body structure design and Smart.HC algorithm control technology used by "CareSYS-jet water knife" are all at the international leading level. The successful development of "CareSYS-jet water knife" is an important breakthrough in the field of medical waterjets and a new milestone in the application of technology.
On March 2, 2020, General Secretary Xi Jinping said in a symposium hosted by the School of Medicine of Tsinghua University: “We must accelerate the shortcomings of China’s high-end medical equipment, accelerate the research on key core technologies, break through the technical equipment bottlenecks, and achieve high-end medical care. Equipment is autonomous and controllable", which points out the specific direction for the development of China's medical equipment industry.
As China's first self-developed medical waterjet, "CareSYS-jet water knife" fills the gap in China's medical waterjet industry. The approval of the "CareSYS-jet water knife" for the market will not only speed up the pace of domestic water jets entering clinical use, but will also force China to enter the era of domestic water jet cleaning innovation!
