Guidelines for Choosing Orthopedic Surgical Robots

Origin:?Radioham C-arm?X-ray machine?

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Choosing orthopedic surgical robots is a complex task that requires comprehensive consideration?of multiple factors to ensure the selection of the most suitable equipment.?The following are key aspects to consider when purchasing orthopedic surgical robots:

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1.Determine requirements

Determine the application scope of your orthopedic surgical robot, such as focusing on spine surgery, trauma surgery, or joint replacement surgery. It is?necessary to choose whether to purchase a single surgical robot or a multi in one surgical robot?based on the size of the hospital and the situation of the department.?

Determine the functional requirements of surgical robots, including navigation, positioning,visualization tools, etc.?

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2.Understand accuracy

Factors affecting the final accuracy of orthopedic surgical robots:

?In theory, a high-precision robotic system should be chosen to ensure?the accuracy of the surgical process.?But many brands claim similar accuracy, taking spinal surgery robots as an example, the commonly claimed accuracy?is?1.5mm.?How should we distinguish it?

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2.1 Navigation?camera?+?tracking tool

The most?commonly?used?navigation camera?in orthopedic robots?is from Canadian?NDI company. The accuracy of?NDI 's cameras is similar, but?the refresh rate is?different.?High refresh rate?cameras have better real-time tracking performance, which ultimately reflects?higher system?accuracy.

The navigation camera needs to track the position of the positioning tool, and the positioning points?on the positioning tool are called?markers. There are?four types of markers as shown in the following figure:?

The first three types are passive reflective, while the fourth type is active light-emitting. The accuracy of the four marking points is as follows:

The vertical axis in the figure represents accuracy(unit:mm), the smaller the better. From the figure, it can be seen that the most accurate markers are those that actively emit light, followed by glass spheres, and the worst are reflective spheres. However, the effective angle of the reflective sphere is also the largest.

In orthopedic surgery, high navigation and positioning accuracy is the most important, and active illuminated markers or glass balls are preferred. Reflective balls should be carefully selected.

2.2 Robotic arm

The robotic arm is the main body of positioning implementation, and its positioning accuracy will affect the system accuracy and safety.?We need to focus on two other parameters of the robotic arm: rated load-bearing capacity and rigidity.?The carrying capacity determines how many tools a robotic arm can pick up; And rigidity determines the displacement magnitude when subjected to external impact.

On the surface, load-bearing capacity is very important, as a high load-bearing capacity leads to high rigidity. In fact, rigidity and load-bearing capacity are not directly related. Rigidity is?reflected in the control parameters of the robotic arm.?We have found?in the practical use of doctors that the importance of rigidity far outweighs load-bearing capacity.?For example, doctors?often encounter tilted bone surfaces when implanting?Kirschner wires,?causing the wires to slip. At this time, the rigid robotic arm will have minimal displacement and resist slipping.?

2.3 End Tool

End tools can also affect system accuracy. Including the degree?of?fit between the installation slot and the instrument, the locking force of the locking device, and the gap size, these?may?all?become factors that affect the repeatability of installation and thus affect the accuracy of the system.?

Some manufacturers have made great efforts to improve machining accuracy and achieve tool consistency;?Some manufacturers, in order to save money, lower their machining accuracy requirements and use a coordinate measuring instrument to calibrate the end of each?set of tools.?Little did they know that relaxing the machining accuracy, although?the front-end length accuracy is guaranteed, the clamping accuracy?cannot be guaranteed, which can also lead to a decrease in system accuracy.?

Visualization of end tool could increase the accuracy during the operation.

2.4 System control

The accuracy of system control, the registration accuracy of software algorithms, and the distortion and artifacts of?medical images themselves can all affect?the overall accuracy of the system.?These performance indicators are difficult?to?reflect in terms of parameters.?When purchasing orthopedic surgical robots, it is best?to?inquire about the comprehensive performance of the target manufacturer's robots?on?social media and evaluate the system control accuracy through multiple trials.?

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2.5 Image accuracy

The requirement for CT image layer thickness?is not greater than?1mm. The parameters of the C-arm?are not explicitly required, but if?there is distortion in the C-arm image,?it will?not affect?traditional surgery, but will affect the accuracy of robotic surgery.?

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3.Convenience of operation

Usability is a word that may sound simple, but is difficult to achieve. The ease of use of orthopedic surgical robots is?one of the important indicators?for measuring their successful application. You can request a trial before purchasing, and multiple doctors will evaluate after?trying it out.

Orthopedic surgical robots are designed to assist surgeons in performing complex?surgical operations, improving the accuracy, stability, and effectiveness of surgeries.?Here are?some factors that affect the usability of orthopedic surgical robots.

3.1 Surgical planning

The?performance of surgical planning determines the efficiency of its use during surgery.?Choose a robot system with surgical planning and simulation capabilities,

To help doctors plan and simulate before surgery, and improve the success?rate?of surgery.?

For example,?before?TKA surgery, the robot automatically performs?CT image segmentation in the background, and during spinal surgery, the robot can automatically plan screws, the doctor only need to adjust guidance slightly.

3.2 Registration

Registration is a unique step in robotic surgery, and frequent?errors can prolong the surgery time.?We need to see?if the robot?can automatically register, if?it supports the registration of intraoperative 2D images and preoperative 3D images, and if it can easily handle the deletion of erroneous point positions when registration errors occur.

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3.3 Easy to operate

Robot operation should be simple and easy to understand, reducing the learning curve.?You can check whether the logic used by the machine conforms to common sense, whether it can be?learned immediately,?and whether it will be forgotten.?Whether there is bedside operation ability, whether?the doctor and assistant?can seamlessly switch operations, and so on.?For example, in?TKA?surgery, the convenience of the surgical robot is determined by whether the doctor can easily expand the boundary, adjust the angle, or perform free?bone cutting.?

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3.4 User interface

The?user interface design should be concise and clear, allowing surgeons to quickly understand and operate.

3.5 Compatibility with existing equipment

?Robots should be able to be compatible?with the hospital's existing?imaging equipment, reducing interference with existing workflows.?

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4. Reliability of products and companies

4.1 Product safety

View medical device product certificates such as?CE, FDA, NMPA, etc.?View third-party testing certificates, journal articles, and clinical trial reports. When reviewing reports, the following aspects should be considered:

a. Safety protection functions, such as collision detection, power-off protection, and emergency stop function.?

b. Risk management during the surgical process.

c. Robot design fully considers the complexity of surgical scenarios and has complete?fault tolerance capabilities.?

If visiting the company, please pay attention to the number of prototypes. If there are only three?or two prototypes?for research and development, there is a high probability that reliability testing, various destructive tests, and product safety cannot be discussed.?

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4.2 Data security:

When conducting preoperative planning,?if computing is done in the cloud,?data security needs to be considered.?

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4.3 Training and Support

a. Training plan:?Surgical robots are complex systems, and manufacturers usually?provide detailed training plans, including simulated operations and practical exercises, to ensure that surgeons are proficient in using the robot.?

b. Technical support:?Provide timely technical support and maintenance services to address any issues that may arise during the surgical process.?

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4.4 Company reliability

a. High value large-scale medical equipment requires a high level of company strength. For?companies that have been established?for a short period of time, it is important to pay close attention?to the company's strength?and be cautious that in a few years, the company may go bankrupt and their products?may not receive maintenance.

b. Research and development personnel situation: Orthopedic surgical robots are complex systems,?and it is difficult to achieve safe and reliable products. The requirements for the number of research and development personnel and engineering capabilities are high, that is, the application ability and experience of the quality system are very high. It is necessary to pay attention to whether its core R&D personnel have experience?in large medical equipment companies, such as Mindray, Lianying, or?GPS.

Attention should also be paid to the number of R&D personnel, especially software engineers. The orthopedic surgical robot is fully involved in the surgical process, and the software guides the entire surgical process. The rationality and safety of software design determine the safety of the orthopedic surgical robot?system.?For example, in?the use of TKA surgical robots,?is the equipment?planned based on force line balance, force balance, or both.?

c. Installation quantity and surgical volume: Good machines are all modified, only through extensive installation and use, obtaining?on-site feedback, and continuously improving products, can good products be made.?If?the installed quantity is only in single digits, special attention should be paid to the safety of the company's products,?and it may be necessary to consider increasing the trial period.?

d. Future Development Trends: Considering the development trend and application of new technologies in the field of orthopedic surgical robots,?select robot systems with future development potential.?Understand?whether?the target company's future research?and development plans align with the future trends of orthopedic surgery, and whether the functions of future research?and development?can be upgraded on current products.

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4.5 Brand and reputation

Choose well-known brands or robot systems with good reputation to ensure the quality and reliability of the equipment.?Refer to the reviews and opinions of other users to understand the advantages and disadvantages of different brands and models.?

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5. Cost effectiveness

Taking into account the purchase cost, maintenance cost, and operating cost of?the robot system comprehensively, to ensure its cost-effectiveness is reasonable.?

Consider the long-term return on investment of robotic systems, including the improvement of?surgical success rates?and the reduction of surgical time.

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This article introduces some basic concepts of orthopedic surgical robots and the issues that need to be considered?when purchasing.?Before purchasing, it is necessary to ensure?sufficient communication?with the manufacturer or distributor, strive for a longer trial period, and?conduct on-site inspections?if possible?to ensure that the orthopedic surgical robot you choose can fully?meet your needs.