FAQ

Introduction to the product composition of laparoscopic surgery system

The product composition of laparoscopic surgery system usually includes the following parts:

Doctor console: This is the platform for doctors to perform surgical operations, and the minimally invasive surgical instruments are controlled through the master-slave control system.

Patient surgery platform: Located next to the operating table, it contains four robotic arms, and the endoscope can be connected to one of the robotic arms to provide a 3D view of the patient's anatomical structure.

Image processing platform: includes image processors and monitors for processing and displaying images sent back by the endoscope.

Three-dimensional laparoscopic endoscope (abbreviated as endoscope): used to observe the situation in the abdominal cavity, usually an electronic endoscope.

Surgical instruments and accessories: including various instruments and accessories used for surgical operations, such as cables, endoscope adapters, and force presentation stamps.

These components work together to enable doctors to perform precise surgical operations in minimally invasive situations.

What are the latest technological advances in laparoscopic surgery systems?

The latest technological advances in laparoscopic surgery systems are mainly concentrated in the following aspects:

4K three-dimensional imaging technology: Mindray has released a 4K three-dimensional electronic thoracoabdominal endoscope system, which uses a dual-channel 4K camera and a 4K image host algorithm post-processing, which can truly reproduce the three-dimensional structure texture of the body cavity, improving the imaging quality and surgical field of view.

Single-port laparoscopic surgery robot: The Surui® robot was approved by the National Medical Products Administration in June 2023 and its scope of application was expanded in February 2024. This robot adopts an eight-direction dual-section inward flip design, with a large field of view adjustment range and clear imaging, marking a major breakthrough in single-port laparoscopic surgery technology.

Fluorescence camera system: Mindray Medical's HyPixel UX5 4K endoscopic fluorescence camera system significantly improves imaging performance through autofocus, automatic scene recognition and intelligent image algorithms, combined with breakthroughs in key fluorescence technologies.

Extended endoscope: Kangji Medical has launched a 450mm extended thoracoabdominal endoscope to meet various surgical needs, especially when different angles are required, providing a larger effective depth of field and an ergonomic viewing angle.

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 fully realizes the automation upgrade of laparoscopic surgery.

How to evaluate the performance and accuracy of laparoscopic endoscopic surgical systems?

Evaluating the performance and accuracy of laparoscopic endoscopic surgical systems requires comprehensive consideration of multiple factors and methods. The following are detailed evaluation steps:

Clinical trials:

Evaluating the safety and effectiveness of laparoscopic endoscopic surgical systems through clinical trials is a key step. Clinical trials can include indicators such as system preparation time, robot-assisted surgery time, instrument performance evaluation, surgeon intraoperative physiological load evaluation, surgeon intraoperative mental load evaluation, postoperative hospital stay days, and pain scores.

The design of clinical trials should be scientific and reasonable to ensure the reliability and effectiveness of data.

Model tests and animal tests:

Before conducting clinical trials, model tests and animal tests can be used to preliminarily verify the performance and safety of the system. These tests can help identify potential problems and provide basic data for clinical trials.

Technical review:

Technical review is another way to confirm the safety and effectiveness of laparoscopic surgical systems in assisting doctors in performing surgery. The review includes an overall evaluation of the test results of the surgical operating system and surgical instruments, and provides a complete research report.

During the review process, attention should also be paid to the test results and analysis of each evaluation indicator during the survival period of each group, as well as the equipment deviation and management of the test and control groups.

Immunity test:

For high-frequency surgical instruments (HFI), it is necessary to evaluate their immunity to the emissions of high-frequency surgical equipment to ensure stability and safety in actual use.

Application of deep learning technology:

Deep learning technology can be used to analyze laparoscopic surgical videos to improve the accuracy and efficiency of surgery. By testing deep learning models, especially convolutional neural networks (CNNs), their accuracy in surgical video analysis can be evaluated.

Standards and Guidelines:

Follow relevant standards and guidelines, such as YY 9706.277 standard, to ensure the compliance and safety of surgical instruments and systems.

Refer to the contents of the "List of Basic Principles for Safety and Performance of Medical Devices" to ensure that the registration application materials of passive surgical instruments and high-frequency surgical instruments in the product composition meet the requirements.

What are the differences in the application of laparoscopic surgical systems in different types of surgeries?

There are significant differences in the application of laparoscopic surgical systems in different types of surgeries, mainly reflected in surgical methods, instrument design and operation accuracy.

Urological surgery:

Laparoscopic surgical systems are mainly used for minimally invasive surgical operations in urological surgery. Through the master-slave control system, physicians can control micro high-precision surgical instruments to improve the accuracy and smoothness of intraoperative operations.
For example, Fosun Pharma's "thoracoabdominal endoscopic surgery control system" is also applicable to urological surgery, further improving the safety and effectiveness of the surgery.

General surgery:

In general surgery, laparoscopic surgical systems are also widely used. It has designed multi-degree-of-freedom surgical instruments that can achieve flexible and precise operations and have a large load capacity.

In addition, the application of 4K laparoscopic systems in general surgical operations has also been recognized by experts, emphasizing the importance of its technical characteristics and standardized practice.

Obstetrics and gynecology surgery:
The application of laparoscopic surgical systems in obstetrics and gynecology is mainly focused on minimally invasive surgery. Through a single-port surgical approach, the endoscope and surgical instruments have multiple active degrees of freedom, and the surgical operation can be completed only by the movement of the surgical instruments in the patient's abdominal cavity.

This single-port surgical approach not only reduces the number of surgical incisions, but also improves the accuracy and safety of the operation.
Thoracic surgery:

In thoracic surgery, laparoscopic surgical systems have also been used. For example, Fosun Pharma's "Thoracoabdominal Endoscopic Surgery Control System" has been approved by the National Medical Products Administration for use in thoracic surgery.

The design and technical requirements of the system ensure the safety and effectiveness of the operation.

Hepatobiliary and pancreatic surgery:
The application of laparoscopic surgical systems in hepatobiliary and pancreatic surgery is also expanding. The research project prospectively evaluated the safety and effectiveness of the system in hepatobiliary and pancreatic surgery, indicating its potential in these complex surgeries.

How is the safety of laparoscopic surgical systems ensured, and what are the potential risks?

The safety of laparoscopic surgical systems is ensured by a variety of methods, including model tests, animal tests, and clinical trials. During the design and development phase, the registrant needs to conduct a performance and safety assessment of the system, and after appropriate risk analysis and assessment, decide to conduct animal tests. In addition, a stability and reliability study of the robotic arm is provided to simulate the effects of various abnormal conditions (such as misoperation, external collisions, etc.) on the stability of the equipment to ensure that unacceptable risks do not occur.

Nevertheless, there are still some potential risks in laparoscopic surgical systems. For example, the radiated emissions and/or conducted emissions of the high-frequency surgical equipment used in conjunction may affect the performance of the endoscopic surgical control system. Insulation loss and excessive leakage current between the patient and the surgical instrument can cause patient injury. In addition, the effect of CO2 pneumoperitoneum on the body's respiratory, circulatory system and systemic hemodynamics is also a concern, especially for patients with reduced tolerance. It is necessary to shorten the operation time as much as possible and simplify the surgical process to minimize the impact of CO2 pneumoperitoneum on the body.

What is the cost-effectiveness analysis of laparoscopic surgery system?

The cost-effectiveness analysis of laparoscopic surgery system is mainly reflected in the following aspects:

Reduce treatment costs: Compared with traditional laparoscopic surgery, laparoscopic surgery system can improve the quality of surgery and ensure the safety of operation. At the same time, compared with imported products, it can significantly reduce treatment costs and reduce the economic burden of patients.

Fine management: By introducing a fine management system for medical equipment, it is possible to query the use status of laparoscopic surgical equipment, analyze the use efficiency, cost-effectiveness analysis and quality control analysis, so as to further optimize the surgical process and reduce costs.

Economic benefit evaluation: When conducting economic evaluation, it is necessary to consider various types of economic evaluation methods and their uses, design features, model parameters, output interpretation, uncertainty analysis and significant limitations. By comparing the costs and effects of different surgical methods, the economic benefits of laparoscopic surgical systems can be determined.

Market Prospects: According to market research reports, the global laparoscopic surgical system market is expected to maintain growth between 2023 and 2029, indicating that the system has good market prospects and development potential.

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