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| Model | Name | Specifications |
| HF2001.7 | Hem-O-Lok Clip Applier | For Large size clips Φ10×330mm |
| HF2001.8 | Hem-O-Lok Clip Applier | For Medium size clips Φ10×330mm |
| HF2001.9 | Hem-O-Lok Clip Applier | For Small size clips Φ5×330mm |
| Package detail: | Poly bag and special shockproof paper box. |
| Delivery detail: | By air |
FAQ
The laparoscopic surgery system is an active surgical instrument used for laparoscopic surgery. Its composition is relatively complex and mainly includes the following parts:
Doctor console: This is the operation center of the surgical system. The doctor remotely controls the minimally invasive surgical instruments through the console.
Patient surgery platform: Located next to the operating table, it contains four robotic arms. The endoscope can be connected to one of the robotic arms to provide a three-dimensional view of the patient's anatomical structure.
Image processing platform: Responsible for processing and displaying the images sent back by the endoscope to ensure a clear field of view during surgery.
Three-dimensional laparoscopic endoscope (abbreviated as endoscope): This is a flexible tubular instrument that can be inserted into the abdominal cavity through a small incision for observation and operation.
Surgical instruments: Including electric instruments, passive surgical instruments, high-frequency surgical instruments, etc., used for specific surgical operations.
Accessories: Such as flushing-suction system, CO2 pneumoperitoneum system, etc., used to assist the surgical process.
These components work together to enable the laparoscopic surgery system to achieve precise and minimally invasive surgical results.
The latest technological advances in laparoscopic surgical systems are mainly concentrated in the following aspects:
Single-port surgical system: In June 2023, the single-port laparoscopic surgical robot of Beijing Surui Robotics Co., Ltd. was approved for listing by the National Medical Products Administration, becoming the first endoscopic single-port surgical system in China. The system is designed with multi-degree-of-freedom surgical instruments with shoulder-elbow-wrist flexible hinge joints to achieve flexible and accurate operation and large load capacity.
4K 3D electronic endoscope: The 4K 3D electronic thoracoabdominal endoscope system released by Mindray uses a dual-channel true 4K camera and 4K image host algorithm post-processing, which can truly reproduce the three-dimensional structure texture of the body cavity, and improve the imaging quality and field of view adjustment range. In addition, the HyPixel UX5 4K endoscopic fluorescence camera system also brings a comprehensive leap in imaging performance, with functions such as autofocus, automatic scene recognition and intelligent image algorithms.
Artificial intelligence and modular design: Borns laparoscopic minimally invasive surgical robot is designed based on the modular, platform and intelligent concept of artificial intelligence. It is compatible with the existing imaging and energy surgical systems of hospitals at all levels, and has the compatibility of traditional 5mm surgical instruments and robot-specific instruments, fully realizing the automation upgrade of laparoscopic surgery.
In the laparoscopic endoscopic surgical system, the commonly used surgical instruments mainly include the following types and their functions and uses:
Trocar (trocar):
Function and use: Trocar is an instrument used to establish intra-abdominal and extra-abdominal channels in laparoscopic surgery. According to the needs of the operation, Trocar has different specifications such as 5mm, 10mm, and 12mm. The inner core of the puncture cone is mainly cone-shaped, which can reduce damage to various layers of tissue.
Electric hook:
Function and use: The electric hook is mainly used to cut and separate tissues, and performs precise cutting and separation operations through the electrothermal effect.
Grasping forceps:
Function and use: Grasping forceps are used to grasp and move tissues to help doctors perform suturing, ligation and other surgical operations. It has precise grasping force and flexible operability, which can reduce surgical trauma and improve surgical results.
Separation forceps:
Function and use: Separation forceps are used to separate and move organs, blood vessels and other tissue structures so that doctors can better observe and operate. Its clamping arm can clamp and fix tissues to facilitate further surgical operations such as cutting and suturing.
Scissors:
Function and use: Laparoscopic surgical scissors are mainly used for cutting and removing tissues. They are usually made of stainless steel and have a double-edged design, which can efficiently complete cutting tasks.
Pneumoperitoneum equipment:
Function and use: Pneumoperitoneum equipment includes pneumoperitoneum machines, CO2 cylinders, gas output pipelines and puncture instruments, etc., which are used to form pneumoperitoneum and provide sufficient space for surgical operations.
Evaluating the safety and efficiency of laparoscopic surgical systems requires comprehensive consideration of multiple factors and data. The following is a detailed evaluation method:
Clinical trial design:
Clinical trials should adopt a prospective, multi-center, randomized controlled study design to ensure the reliability and representativeness of the results.
The primary efficacy endpoint of the trial needs to observe the entire surgical process, and the primary safety endpoint and secondary endpoint need to be observed until 30 days after surgery.
Adverse event observation and statistics:
In the experimental study, it is recommended to observe relevant adverse events as much as possible, and statistically calculate the incidence and evaluate comprehensive complications.
If the safety evaluation index is different from the guiding principle, the setting basis should be given and whether the safety observation endpoint can be met should be evaluated.
Animal testing and model testing:
When the laparoscopic surgical system is first applied for marketing, and when the product change involves the evaluation of surgical safety and surgical effect, animal testing is usually required.
If the product change does not involve the evaluation of surgical safety and surgical effect, animal testing may not be carried out, and model testing evaluation may be used.
Risk analysis and performance evaluation:
During the design and development stage of the product, the registrant should conduct performance and safety evaluation of the endoscopic surgical system, and after appropriate risk analysis and evaluation, decide to conduct animal testing.
Comparative study:
The effectiveness and safety of laparoscopic endoscopic surgical systems for specific surgeries (such as thoracoscopic radical resection of lung cancer) can be evaluated by comparing with similar products that have been launched in China.
For example, the safety and effectiveness of the Precision Laparoscopic Endoscopic Surgical System (MP1000) compared with the Da Vinci Endoscopic Surgical Control System (IS 4000/IS 3000) can be evaluated.
Registration Review Guidelines:
The registration review guidelines provide detailed evaluation criteria and requirements. Applicants need to determine whether the content is applicable based on the specific characteristics of the product and provide corresponding scientific evidence.
Laparoscopic endoscopic surgical systems have a wide range of application cases in different types of surgeries. Here are some specific examples:
Prostatectomy: The domestic Condo endoscopic surgical robot system was used for extraperitoneal radical prostatectomy and full periurethral reconstruction, and its safety and effectiveness were preliminarily evaluated.
Abdominal wall hernia repair: Peking University People's Hospital used the domestic Condo robot to assist in the first laparoscopic abdominal wall hernia repair in China, verifying the safety and effectiveness of the system.
Adrenal tumor resection: Peking Union Medical College Hospital used the domestic Condo endoscopic surgical robot system to perform five adrenal tumor resections and explored its safety and effectiveness.
Urological surgery: The laparoscopic endoscopic surgical system of Shanghai Microport Medical Robotics (Group) Co., Ltd. was studied in a prospective, multicenter, randomized controlled study in urological surgery to verify its safety and effectiveness.
The future development trends and potential improvement directions of laparoscopic endoscopic surgical systems mainly include the following aspects:
Technology upgrade and iteration: The laparoscopic endoscopic surgical system will continue to upgrade and iterate its products to improve the accuracy and safety of the surgery. For example, the application of 3D laparoscopic technology in complex surgery can significantly improve the completion of the surgery and the patient's postoperative recovery level.
Multiple technology integration: One of the future development trends is the deep integration of multiple technologies and processes. This includes the application of 4K high-definition display technology, which greatly improves the resolution of surgical images, thereby better assisting doctors in their operations.
Market size growth: The global laparoscopic surgical system market is expected to continue to maintain steady growth, and by 2030 the market size will be close to several times the current level, and the annual compound growth rate (CAGR) will also remain at a high level.
Acceleration of domestic substitution process: With the independent breakthrough of technology, the process of domestic substitution will accelerate, and domestic companies will gradually occupy a larger market share.
Extension of the entire industrial chain: Future development will also involve the extension of the entire industrial chain, from research and development to production to sales and services, forming a complete ecosystem.
The future development of laparoscopic surgical systems will focus on technology upgrades, multiple technology integration, market size expansion, accelerated domestic substitution, and extension of the entire industrial chain.
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Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
Sales: Aiden
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