FAQ

What are the basic components of minimally invasive surgical instruments?

The basic components of minimally invasive surgical instruments mainly include the following parts:

Console: This is the core part of the minimally invasive surgical system. The surgeon controls the entire operation through the console. The console is usually composed of a computer system, a surgical operation monitor, a robot control monitor, an operating handle, and input and output devices.

Operating arm: Used to perform specific surgical operations and connected to the console.

Image processing system: Used to provide images and videos during the operation to help surgeons perform precise operations.

Consumables: Includes various disposable medical devices, such as staplers, ultrasonic cutting hemostats, disposable forceps, ligation clips, reusable forceps, medical sutures, etc.

Closure and closure needle: Used to close the incision after the operation to ensure wound healing.

Main operating sheath and dilator: Used to establish an operating space required for the operation between the body and the surgical site.

These components work together to ensure the smooth progress and efficient completion of minimally invasive surgery.

What are the latest technological advances in minimally invasive surgical instruments?

The latest technological advances in minimally invasive surgical instruments are mainly concentrated in the following aspects:

Intelligent surgical robot: The "Miaoshou" robot launched by Weigao adopts multi-degree-of-freedom wire transmission decoupling design technology, which improves the flexibility of instrument movement and tissue processing capabilities, and pioneered the master-slave heterogeneous space mapping technology. In addition, the Vicente surgical robot has functions such as real-time intraoperative navigation, automatic suture suturing and automatic stapler anastomosis, gradually realizing automated surgical operations led by AI.

Flexible fiber robot laser scalpel: The team of Academician Yang Guangzhong of the Medical Robotics Research Institute of Shanghai Jiaotong University proposed a new minimally invasive surgical processing technology-flexible fiber robot laser scalpel, which aims to improve the accuracy of intelligent medical robots.

Transumbilical single-port laparoscopic surgery: This internationally cutting-edge minimally invasive technology uses the umbilical wrinkle wall to cover the surgical incision, and surgical instruments and equipment enter the abdominal cavity through the umbilical hole, further promoting the development of minimally invasive surgery.

Endoscopic image recognition technology: In the field of computer- and robot-assisted minimally invasive surgery, great progress has been made in the identification of surgical instruments in endoscopic images, especially the determination of the location and type of instruments. The application of these technologies may improve the quality of surgical segmentation.

What are the application cases of minimally invasive surgical instruments in different types of surgery?

The application cases of minimally invasive surgical instruments in different types of surgery are very extensive. Here are some specific examples:

Laparoscopic surgery: Laparoscopic surgery is one of the common minimally invasive surgeries, which is performed using modern medical instruments such as laparoscopes and thoracoscopes. For example, single-incision laparoscopic surgery, hand-assisted laparoscopic surgery (HALS), robot-assisted laparoscopic surgery, etc.

Cerebral artery interventional surgery: Minimally invasive Brain Science Co., Ltd. cooperated with Pudong Hospital Affiliated to Fudan University to successfully complete the world's first percutaneous reverse flow brain protection carotid artery revascularization (pcar), saving a patient with severe carotid stenosis.

Sacral tumor resection: In robot-assisted sacral tumor resection, a minimally invasive ultrasonic bone knife was used for osteotomy. Although there are no related reports, this technology demonstrates the potential for the application of minimally invasive surgical instruments in complex surgeries.

Single-port laparoscopic surgery: Ruijin Hospital completed my country's first single-port surgical robot surgery with complete independent intellectual property rights, marking the first application of domestic single-port robots in the field of surgery.

Gynecological minimally invasive surgery: In Shanghai, the first 5G+AI ultra-long-distance domestic robot minimally invasive surgery was successfully completed, demonstrating the application capabilities of domestic robot remote surgery in complex and delicate gynecological minimally invasive surgery.

Spinal surgery: The Department of Spine Surgery of the Aviation General Hospital uses minimally invasive endoscopic surgery to treat diseases such as cervical spondylosis, lumbar disc herniation, lumbar spinal stenosis and lumbar spondylolisthesis, and uses percutaneous nailing surgery and vertebral balloon angioplasty to treat spinal compression fractures.

What are the safety assessment standards and regulatory requirements for minimally invasive surgical instruments?

The safety assessment standards and regulatory requirements for minimally invasive surgical instruments mainly include the following aspects:

Production license and compliance with regulations: Manufacturers of minimally invasive and interventional surgical instruments must obtain medical device production licenses in accordance with the law and strictly comply with relevant regulations and standards for production. During the production process, enterprises must accept supervision and inspection by relevant regulatory authorities, and products must undergo strict inspection and testing before leaving the factory to ensure compliance with regulations and standards.

Safety standards: Minimally invasive surgical instruments need to comply with general safety standards related to medical electrical equipment (such as GB 9706.1-2007), special safety standards (such as GB 9706.4-2009, GB 9706.19-2000) and other relevant medical device industry standards. In addition, ISO 13485 medical device quality management system requirements must also be complied with.

Registration review guidelines: The State Food and Drug Administration has issued a number of registration review guidelines to strengthen the supervision and guidance of medical device product registration and improve the quality of registration review. For example, documents such as the "Guidelines for Registration Review of Arthroscopic Passive Surgical Instruments" provide specific guidance on the registration review of minimally invasive surgical instruments.

Clinical research and evaluation: Conduct multi-center clinical research to evaluate the safety and effectiveness of minimally invasive surgery.

EU market certification: In the EU market, minimally invasive surgical instruments need to comply with the certification requirements of the EU Medical Device Regulation (MDR), which is crucial for market access.

How to choose the right minimally invasive surgical instrument for a specific surgical procedure?

The following aspects need to be considered when choosing the right minimally invasive surgical instrument for a specific surgical procedure:

Surgery type and requirements: First, clarify the specific type and requirements of the surgery. For example, laparoscopic gastric cancer surgery, hepatobiliary and pancreatic surgery, etc. have their specific instrument requirements.

Medical device classification: According to the "Medical Device Classification Catalog", active or passive medical devices suitable for surgical treatment purposes can be selected.

Materials and design: The selected instruments should be designed for advanced minimally invasive and single-incision surgery, and have different materials (such as stainless steel, titanium, nylon, polytetrafluoroethylene, silicon or fiberglass) to reduce the size of the incision, reduce scarring and postoperative recovery.

Technical guidelines and standards: Refer to relevant technical guidelines and standards to ensure that the selected instruments meet the requirements of clinical applications. For example, the CMDE official website provides technical guidelines and standards for various medical devices.

Surgical operation guide: Check the relevant surgical operation guide to understand the instruments and operation methods required for specific operations. For example, the "Robotic Hepatobiliary and Pancreatic Surgery Operation Guide" details the advantages and operation steps of using a robotic system.

What are the future development trends and potential challenges of minimally invasive surgical instruments?

The future development trends and potential challenges of minimally invasive surgical instruments can be analyzed from multiple aspects.

Future development trends
One of the development trends of minimally invasive surgical instruments is technological innovation and digitalization. With the advancement of science and technology, minimally invasive surgical instruments in the future will be more intelligent and automated, and can provide higher precision and convenience of operation.

Robotic technology is increasingly used in minimally invasive surgery. Minimally invasive surgical robots can provide more sophisticated operations, reduce the workload of doctors, and improve the safety and success rate of surgery.

With the development of domestic product technology, domestic brands have gained more market share in the minimally invasive surgical instrument market. Although the current market is mainly dominated by foreign companies, domestic brands are gradually narrowing the gap and occupying an important position in certain market segments.

The scale of the minimally invasive surgical instrument market continues to grow. For example, the size of the ultrasonic knife market has grown from 2.008 billion yuan in 2020 to 2.513 billion yuan in 2021, showing a strong growth momentum.

Potential Challenges
Although domestic brands have made some technological progress, there is still a certain gap compared with international giants. Foreign companies still have advantages in product technology and quality, and domestic companies need to further improve their technical level and product quality to cope with competition.

As the complexity of minimally invasive surgical instruments increases, doctors need to receive more professional training to be proficient in using these devices. In addition, complex operations may also increase surgical risks and the incidence of complications.

High-end minimally invasive surgical instruments are usually expensive, which may be a burden for some medical institutions. How to balance costs and benefits and ensure that more patients can benefit from minimally invasive surgery is a problem that needs to be solved.

With the popularity of minimally invasive surgery, market demand continues to increase. How to effectively manage and optimize the supply chain to ensure the timely supply and maintenance of instruments is the key to future development.

The future development of minimally invasive surgical instruments is full of opportunities and challenges.

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Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
Sales: Aiden