Intelligent corneal lens / corneal flap separating device for corneal refraction operation

Abstract

The invention discloses an intelligent corneal lens / corneal flap separating device for a corneal refraction operation, and belongs to the technical field of ophthalmologic operation instruments. The two-degree-of-freedom force sensing module is electrically connected with the embedded hardware module and used for collecting force signals in the separation process. The attitude sensing module is in communication connection with the embedded hardware module and is used for acquiring pitch angle and roll angle data of the instrument; the upper computer communicates with the embedded hardware module and is used for receiving and processing data; the dynamic compensation algorithm is integrated in the embedded hardware module and is used for eliminating errors caused by inclination of the instrument; the device can output force-angle data in real time and store the data in a structured format, quantitative basis is provided for surgical operation, and mechanical damage to cornea tissue can be avoided; objective data basis is provided for doctors through a high-precision sensor with the force measurement precision of + / -1mN and the angle measurement precision of + / -1 degree, the traditional operation mode of hand feeling dependence is thoroughly changed, and the operation process can be quantified and traced.

Description

Technical Field

[0001] This invention belongs to the field of ophthalmic surgical instrument technology, specifically referring to an intelligent corneal lens / corneal flap separation device for corneal refractive surgery. Background Technology

[0002] Corneal refractive surgery is the mainstream procedure for correcting refractive errors such as myopia and hyperopia. Among them, the KLEx procedure uses a femtosecond laser to create a microlens in the corneal stroma and then separates and removes it. The femtosecond LASIK procedure uses a femtosecond laser to create a corneal flap and then ablates the stroma. The core difficulty of both procedures lies in the separation of the corneal lenticule / corneal flap—it is necessary to ensure the complete removal of tissue while avoiding mechanical damage to the surrounding corneal stroma.

[0003] Currently, the separation instruments and related technologies widely used in clinical practice have the following key shortcomings: Operation relies on subjective experience and lacks objective mechanical feedback: Traditional mechanical separation instruments (such as blunt scrapers and miniature hooks) rely entirely on the doctor's feel to control the force and angle. Even the improved "controllable electric uniform speed lens separator" (application number: 202211253041.2, publication number: CN115645147A), although it achieves uniform speed movement through a hollow cup motor, does not integrate a force sensing module and cannot monitor the magnitude and direction of the separation force in real time. There is still a risk of corneal stromal irritation or lens residue due to improper force. The "femtosecond lens separation spatula with U-shaped bending structure" (application number: 202211698769.6, publication number: CN115813658A) only optimizes the operating space through geometric structure and is still a purely mechanical design without any mechanical data support.

[0004] Insufficient control of separation resistance and limitations of lubrication and vibration assistance: The "all-femtosecond lenticule separator with reservoir" (application number: 202410730158.8, publication number: CN118717410A) achieves local lubrication through the reservoir, but relies on capillary action or pre-injection fluid, making it difficult to precisely control the amount and penetration range of the fluid, which can easily lead to an impact on the surgical field or fluctuations in separation force; Although the "high-frequency vibration lenticule separator" (application number: 202323073059.7, authorization announcement number: CN221654796U) uses vibration to assist separation, the vibration is still partially transmitted to the handle (even with the addition of a shock absorber), interfering with the doctor's hand stability, and there is no real-time force feedback, making it impossible to determine whether the vibration has excessively damaged the tissue.

[0005] Lack of data recording and review capabilities, and low level of intelligence: None of the existing instruments have integrated data acquisition functions, making it impossible to record key parameters such as force and angle during the operation. This results in the inability to review operational details after the operation, make it difficult to optimize surgical parameters (such as femtosecond laser energy and incision location), and also fail to provide quantitative references for training new doctors. Although the international patent "Vibration Surgical Instrument" (PCT / US2022 / 051854) mentions vibration parameter control, it does not achieve multi-dimensional force and posture monitoring and does not form an intelligent closed loop of "acquisition-analysis-feedback".

[0006] The operation of the standard operation depends on manual operation, which is prone to errors: In the operation of existing sensor-based assistive devices, it is necessary to avoid manual contact with the cone-shaped protrusion of the sensor and to calibrate it through the pedal. However, there is a lack of coordinated constraints between hardware and software. If the calibration is not standardized or the pressure exceeds 1N during operation, it can easily lead to sensor damage or corneal tissue damage, further highlighting the shortcomings of the existing technology in "operational safety and standardization".

[0007] In summary, existing technologies cannot meet the requirements of corneal refractive surgery for "quantitative operation, real-time feedback, and data traceability." There is an urgent need for a separate device that integrates multiple sensors, dynamic compensation, and intelligent feedback to solve the above-mentioned technical deficiencies. Summary of the Invention

[0008] To address the shortcomings of existing technologies, the core objective of this invention is to provide an intelligent corneal lenticule / corneal flap separation device for corneal refractive surgery, specifically achieving the following objectives: 1. Real-time monitoring of three-dimensional forces (X-axis force, Z-axis force) and instrument posture angles (pitch angle, roll angle) during surgery provides doctors with quantitative operational basis, avoiding excessive force ≤1N or tissue damage caused by angle deviation.

[0009] 2. Enables real-time visualization and structured storage of force and angle data, supporting postoperative review, surgical parameter optimization, and clinical research.

[0010] 3. Eliminate measurement errors caused by instrument tilt through dynamic compensation algorithms, and improve operational safety by combining intelligent early warning (such as vibration alerts for excessive force).

[0011] 4. It adopts a modular design to adapt to different surgical instruments (scraping tools, hook needles) and sterile surgical environments, taking into account both flexibility and compatibility.

[0012] The technical solution of this invention is based on "hardware integration + algorithm optimization + software collaboration", specifically including an embedded hardware module, a dual-degree-of-freedom force sensing module, an attitude sensing module, host computer software and a dynamic compensation algorithm, and each part works together to achieve intelligent separation function.

[0013] This invention provides an intelligent corneal lenticule / corneal flap separation device for corneal refractive surgery, comprising: Embedded hardware modules serve as the core control unit; A dual-degree-of-freedom force sensing module is electrically connected to the embedded hardware module and is used to acquire X-axis and Z-axis force signals during the separation process; The attitude sensing module is communicatively connected to the embedded hardware module and is used to collect the pitch and roll angle data of the instrument. The host computer communicates with the embedded hardware module to receive and process data; A dynamic compensation algorithm, integrated into the embedded hardware module, is used to eliminate force measurement errors caused by instrument tilt.

[0014] Preferably, the dual-degree-of-freedom force sensing module includes two S-shaped load cells and a matching amplifier; The amplifiers are connected to the pins of the microcontroller, converting the raw voltage signal output by the sensor into a digital value via a 24-bit ADC. The raw force value is calculated using the following formula: ; Where k is the initial gain coefficient (default 0.63), and calibration_factor is obtained through offline calibration.

[0015] Preferably, the attitude sensing module is a nine-axis IMU sensor, which transmits three-axis acceleration, angular velocity, and Euler angle data to the embedded hardware module via a Serial1 serial port; the data conversion formulas are as follows: Accelerometer conversion: ; Angular velocity conversion: ; Angle conversion: ; Among them, RAW Acc The raw acceleration value output by the sensor; RAW Gyro The original value of angular velocity, RAW Angle These are the original values ​​for Euler angles.

[0016] Preferably, the dynamic compensation algorithm includes a two-stage compensation mechanism; Zero-point drift compensation: Triggered by a single pedal press, the current force sensor reading F is recorded. tare The IMU pitch angle θ1 and roll angle θ2 are used as reference values, and the reference values ​​are stored as Z. tareAngle [0]=θ1、Z tareAngle [1]=θ 2； Tilt force decoupling calculation: Based on the real-time attitude angle dynamic correction force sensor output, gravity component interference is eliminated. The decoupling formula is as follows: ; Where L0 and L1 are the raw values ​​of the force sensor, k0 and k1 are the calibration gain, Θ is the real-time angle of the IMU, and μ is the compensation offset.

[0017] Preferably, it also includes a multi-point linear compensation calibration mode: calibration is triggered by three pedal presses, and the host computer sends a reference force value to the embedded hardware module; the system records the sensor's measured output and reference value at different angles, and generates a compensation table compForce[2]

[10] [2]. The measured X-axis value in the compensation table is calculated according to... calculate; X-axis reference value according to calculate; During runtime, the force output is corrected by looking up a table and using linear interpolation. The data error tolerance threshold is set to ±500mN, and data exceeding the threshold is automatically discarded.

[0018] Preferably, the host computer is developed based on Qt and has the following functions: Dynamic plotting with dual Y-axis, where angle data is in degrees and force data is in mN; Data filtering automatically filters out abnormal data when the force value changes by more than 500mN; Data storage is performed in CSV format with timestamps, including timestamps, pitch angle, roll angle, X-axis force value, and Z-axis force value. The embedded hardware module sends CSV format data frames to the host computer via a serial port. The data frame format is [angle_pitch][\t][angle_roll][\t][Fx][\t][Fz].

[0019] Preferably, the operating procedure of the device includes: opening the software after the sensor is powered on, and not touching the lower conical protrusion when holding the sensor handle; Before use, calibrate the sensor using the pedal. During the calibration process, keep the sensor stationary and without pressure. When using the sensor probe tip to contact an object, the pressure applied should not exceed 1N to avoid damage to the sensor and excessive stress on the corneal tissue.

[0020] Preferably, the embedded hardware module communicates with the host computer via serial port interaction, including a debug serial port and a dedicated sensor port, to avoid data conflicts; Alternatively, Bluetooth Low Energy transmission can be used to replace serial communication, eliminating cable constraints and adapting to sterile surgical environments.

[0021] Preferably, a modular design is used: The dual-degree-of-freedom force sensing module and attitude sensing module are replaceable modules that can be adapted to different types of surgical instruments; the embedded hardware module is designed with reference to the joint unit interlocking part of the clamping force feedback surgical forceps, and can be bent to adapt to different surgical operation angle requirements.

[0022] Preferably, it features a fault-tolerant and robust design: the host computer is equipped with a real-time monitoring thread that checks the communication status with the embedded hardware module every 200ms. If the communication is interrupted and the timeout occurs, the serial port is automatically restarted. The range of the collected data is limited, with the force value range being -1000mN to 1000mN and the angle value range being -360° to 360°. Data outside the range is judged as invalid data and discarded.

[0023] Compared with the prior art, the beneficial effects of the present invention are as follows: This invention is the first to achieve real-time quantification of three-dimensional force and posture angles during corneal lenticule / corneal flap separation. It provides doctors with objective data through high-precision sensors with force measurement accuracy of ±1mN and angle measurement accuracy of ±1°, completely changing the traditional "feel-dependent" operation mode and making the surgical process quantifiable and traceable.

[0024] This invention combines a dynamic compensation algorithm to eliminate tilt errors and ensure the accuracy of force measurement; through the dual constraint of "hardware warning + software prompts", it avoids operating pressure exceeding 1N, effectively reducing the risk of complications such as corneal stromal damage, lenticule tearing or residue; real-time force-angle curve visualization helps doctors adjust the operating force and angle in real time, improving the controllability of the surgery. Attached Figure Description

[0025] Figure 1 This is an arbitrary side view of an embodiment of the present invention; Figure 2 This is an arbitrary half-side view of an embodiment of the present invention. Detailed Implementation

[0026] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection.

[0027] like Figure 1 and Figure 2 The embodiment of the present invention shown provides an intelligent corneal lenticule / corneal flap separation device for corneal refractive surgery, comprising: Embedded hardware modules serve as the core control unit; A dual-degree-of-freedom force sensing module is electrically connected to the embedded hardware module and is used to acquire X-axis and Z-axis force signals during the separation process; The attitude sensing module is communicatively connected to the embedded hardware module and is used to collect the pitch and roll angle data of the instrument. The host computer communicates with the embedded hardware module to receive and process data; A dynamic compensation algorithm, integrated into the embedded hardware module, is used to eliminate force measurement errors caused by instrument tilt.

[0028] In a further embodiment of this example, the dual-degree-of-freedom force sensing module includes two S-shaped load cells and a matching amplifier. The amplifiers are connected to the pins of the microcontroller, converting the raw voltage signal output by the sensor into a digital value via a 24-bit ADC. The raw force value is calculated using the following formula: ; Where k is the initial gain coefficient (default 0.63), and calibration_factor is obtained through offline calibration.

[0029] In a further embodiment of this example, the attitude sensing module is a nine-axis IMU sensor, which transmits three-axis acceleration, angular velocity, and Euler angle data to the embedded hardware module via a Serial1 serial port; the data conversion formulas are as follows: Accelerometer conversion: ; Angular velocity conversion: ; Angle conversion: ; Among them, RAW Acc The raw acceleration value output by the sensor; RAW Gyro The original value of angular velocity, RAW Angle These are the original values ​​for Euler angles.

[0030] In a further embodiment of this example, the dynamic compensation algorithm includes a two-stage compensation mechanism: Zero-point drift compensation: Triggered by a single pedal press, the current force sensor reading F is recorded. tare The IMU pitch angle θ1 and roll angle θ2 are used as reference values, and the reference values ​​are stored as Z. tareAngle [0]=θ1、Z tareAngle [1]=θ 2； Tilt force decoupling calculation: Based on the real-time attitude angle dynamic correction force sensor output, gravity component interference is eliminated. The decoupling formula is as follows: ; Where L0 and L1 are the raw values ​​of the force sensor, k0 and k1 are the calibration gain, Θ is the real-time angle of the IMU, and μ is the compensation offset.

[0031] In a further embodiment of this invention, a multi-point linear compensation calibration mode is also included: calibration is triggered by three pedal presses, and the host computer sends a reference force value to the embedded hardware module; the system records the sensor's measured output and reference value at different angles, and generates a compensation table compForce[2]

[10] [2]. The measured X-axis value in the compensation table is calculated according to... calculate, X-axis reference value according to calculate.

[0032] During runtime, the force output is corrected by looking up a table and using linear interpolation. The data error tolerance threshold is set to ±500mN, and data exceeding the threshold is automatically discarded.

[0033] In a further embodiment of this example, the host computer is developed based on Qt and has the following functions: Dynamic plotting with dual Y-axis, where angle data is in degrees and force data is in mN; Data filtering automatically filters out abnormal data when the force value changes by more than 500mN; Data storage is performed in CSV format with timestamps, including timestamps, pitch angle, roll angle, X-axis force value, and Z-axis force value. The embedded hardware module sends CSV format data frames to the host computer via a serial port. The data frame format is [angle_pitch][\t][angle_roll][\t][Fx][\t][Fz].

[0034] In a further embodiment of this example, the operating procedure of the device includes: opening the software after the sensor is powered on, and not touching the lower conical protrusion when holding the sensor handle; Before use, calibrate the sensor using the pedal. During the calibration process, keep the sensor stationary and without pressure. When using the sensor probe tip to contact an object, the pressure applied should not exceed 1N to avoid damage to the sensor and excessive stress on the corneal tissue.

[0035] In a further embodiment of this example, the communication between the embedded hardware module and the host computer is via serial port interaction, including a debug serial port and a dedicated sensor port, to avoid data conflicts. Alternatively, Bluetooth Low Energy transmission can be used to replace serial communication, eliminating cable constraints and adapting to sterile surgical environments.

[0036] In a further embodiment of this example, a modular design is used: The dual-degree-of-freedom force sensing module and attitude sensing module are replaceable modules that can be adapted to different types of surgical instruments; the embedded hardware module is designed with reference to the joint unit interlocking part of the clamping force feedback surgical forceps, and can be bent to adapt to different surgical operation angle requirements.

[0037] In a further implementation of this embodiment, fault-tolerant and robust design is provided: the host computer is equipped with a real-time monitoring thread that checks the communication status with the embedded hardware module every 200ms. If the communication interruption times out, the serial port is automatically restarted; the range of the collected data is limited, with the force value range being -1000mN to 1000mN and the angle value range being -360° to 360°. Data outside the range is determined to be invalid data and discarded.

[0038] It should be noted that the core hardware of this device is an "embedded control unit + dual-sensor module", and the connection relationships and parameters of each component are as follows: Embedded hardware module: It adopts a microcontroller as the core control unit, has multi-pin expansion capability, supports simultaneous connection of force sensing module and attitude sensing module, and is responsible for data acquisition, algorithm calculation and communication with host computer; Dual-DOF force sensing module: Includes two S-type load cells (maximum capacity 5N, suitable for pressure requirements ≤1N during surgery) and a matching weighing module; the two weighing modules are connected to the microcontroller via pins, converting the raw voltage signals output by the sensors into 24-bit digital values ​​to ensure force measurement accuracy; the formula for calculating the raw force value is as follows: ; Where k is the initial gain coefficient (default 0.63), and calibration_factor is the calibration factor obtained through offline calibration, used to correct for individual sensor differences; Attitude sensing module: Employs a nine-axis IMU sensor (integrating a three-axis accelerometer, a three-axis gyroscope, and a three-axis magnetometer), connected to the microcontroller via a Serial1 port (communication rate 115200bps) to transmit the instrument's three-axis acceleration, angular velocity, and Euler angle data in real time; the data conversion formula is as follows: Acceleration (unit: g): ; RAW Acc This is the raw acceleration value output by the sensor; Angular velocity (unit: ° / s): RAW Gyro This is the original value of the angular velocity; Angle (unit: °): RAW Angle These are the original values ​​of Euler angles; The host computer software is developed based on Qt. It communicates with the embedded module via serial port to realize data reception, visualization, filtering and storage functions, and supports dynamic plotting on dual Y-axis (angle axis unit: °, force axis unit: mN).

[0039] Dynamic compensation and calibration algorithm: To solve the force measurement error caused by instrument tilt (superposition of gravity components), this invention designs a two-stage dynamic compensation mechanism and a multi-point linear calibration mode.

[0040] Phase 1: Zero-point drift compensation (Tare) triggering method: Calibration is initiated by a single pedal press, during which the sensor must remain stationary and without pressure; Calibration process: The system records the current force sensor reading F. tare The pitch angle θ1 and roll angle θ2 of the IMU are recorded and stored as reference values: Z tareAngle [0]=θ1、Z tareAngle [1] = θ2, used to eliminate the initial drift later; The second stage: Tilt force decoupling calculation is based on the real-time acquired IMU attitude angle, dynamically corrects the force sensor output, and eliminates gravity component interference. The decoupling formula is as follows: ; Where L0 and L1 are the raw values ​​of the force sensor, k0 and k1 are the calibration gain, Θ is the real-time angle of the IMU, and μ x / μ z The compensation offset for the X-axis / Z-axis (obtained through offline calibration); Multi-point linear compensation calibration triggering method: Enter calibration mode by stepping on the pedal three times, and the host computer sends the preset reference force value to the embedded module; Compensation table construction: The system records the sensor measured output (outForce) and reference force value (refForce) under different attitude angles, and generates a two-dimensional compensation table compForce[2]

[10] [2], where the measured value of the X-axis is calculated as: ; The X-axis reference value is calculated as follows: ; (x_GAIN is the X-axis gain coefficient); Runtime correction: The real-time force output is corrected by looking up a table and linear interpolation. The error tolerance threshold is set to ±500mN. Data exceeding the threshold is automatically discarded to ensure measurement accuracy.

[0041] Data Communication and Fault Tolerance Design: Data Transmission Protocol: The embedded module sends CSV format data frames to the host computer via serial port. The frame structure is: [angle_pitch][\t][angle_roll][\t][Fx][\t][Fz] (Example: -15.2\t3.8\t120.5\t-98.3), where anglepitch is the pitch angle, angleroll is the roll angle, Fx is the X-axis force value, and Fz is the Z-axis force value; Optional Communication Scheme: Serial communication can be replaced with Bluetooth Low Energy (BLE) transmission to eliminate cable constraints and adapt to the aseptic operating environment during surgery.

[0042] Serial port interaction: Avoids conflicts between debugging data and sensor data, ensuring stable data transmission.

[0043] Real-time monitoring and data verification: The host computer is equipped with an independent monitoring thread that checks the communication status with the embedded module every 200ms. If the communication is interrupted and the timeout occurs, the serial port will be automatically restarted. The range of collected data is limited: the force range is -1000mN to 1000mN (covering the requirement of ≤1N in surgery), and the angle range is -360° to 360°. Data outside the range is judged as invalid data and discarded to avoid abnormal data interfering with surgical judgment.

[0044] Modular design and compatibility with operating procedures: Replaceable sensor modules: The dual-degree-of-freedom force sensor module and attitude sensor module are designed as independent modules, which can be replaced to adapt to different instruments (such as blunt scrapers and miniature hooks) according to surgical needs. The module interface adopts a foolproof design to avoid installation errors.

[0045] Operating specifications and hardware constraints: The conical protrusion below the sensor handle features an anti-slip isolation design to remind doctors to avoid hand contact; a pressure protection mechanism is set up at the hardware level. When the pressure at the probe tip exceeds 1N, the embedded module triggers a buzzer warning, and at the same time, the host computer pops up a red prompt box to forcibly remind the doctor to reduce the pressure and avoid damage to the sensor and corneal tissue.

[0046] The preoperative calibration procedure for this device is as follows: Zero drift compensation (Tare); The sensor is powered on, the host computer software is opened, and the doctor holds the sensor handle, ensuring that his hand does not touch the cone-shaped protrusion below. Place the sensor on a horizontal, sterile workbench, keeping it stationary and pressure-free. With a single press of the pedal, the system automatically records the current force sensor reading F. tare With the IMU angles θ1 and θ2, the host computer interface displays "Zero-point calibration complete" and the force curve returns to zero.

[0047] Multi-point linear compensation: After three rapid pedal presses, the system enters linear calibration mode. The host computer will display a "Calibration Reference Value Input" window, where you can input five sets of reference force values ​​(such as 0mN, 200mN, 500mN, 800mN, and 1000mN). After each set of reference force values ​​is input, the corresponding pressure is applied to the sensor using standard weights and held for 3 seconds. The system automatically records the current sensor output value and attitude angle and generates a compensation table compForce[2]

[10] [2]. After the group of data is collected, the host computer automatically completes the linear interpolation calculation and displays "Linear calibration completed". The calibration parameters are automatically saved to the embedded module.

[0048] The surgical procedure for this device is as follows: Preoperative preparation: The assembled device is sterilized (focusing on the sensor handle and probe tip). The doctor puts on sterile gloves and confirms again that the hand does not touch the cone protrusion.

[0049] Data monitoring initiated: Click the "Start Monitoring" button on the host computer. The software enters real-time plotting mode, displaying the angle (left side, unit °) and force value (right side, unit mN) on the dual Y-axis, with data refreshed in real time.

[0050] Separation procedure: The doctor holds the handle and controls the probe tip to contact the edge of the corneal lenticule / corneal flap, applying slight pressure (≤1N) and slowly performing the separation procedure; the doctor observes the curve on the host computer in real time during the process.

[0051] If the force value is close to 1N, the system will trigger a buzzer warning and the force value curve of the host computer will turn orange. If the force exceeds 1N, the beep will continue, the curve will turn red, and the software will display a "Pressure Exceeded" warning box. The doctor must immediately reduce the force to avoid exceeding the safety requirement of 1N pressure.

[0052] Data Recording: During the surgery, the host computer automatically stores the data with the filename "Surgery Date_Time.csv". Each row of data includes a timestamp (accurate to milliseconds), pitch angle, roll angle, and F-number. x F z。

[0053] Postoperative care: After the surgery, click the "Stop Monitoring" button. The data file will be automatically saved to the preset path. You can view the force-time and angle-time curves through the software's "Data Analysis" function, or export the data for postoperative review.

[0054] The troubleshooting procedure for this equipment is as follows: Communication interruption: If the host computer displays "Communication interruption", check the USB cable connection or Bluetooth pairing status. The system will automatically restart the serial port. No recalibration is required after restarting (calibration parameters have been saved).

[0055] Abnormal force drift: If the force curve continues to drift when there is no operation, zero-point drift compensation (single pedal press) needs to be re-executed.

[0056] False alarm trigger: If an alarm is triggered even though the value is less than 1N, linear calibration must be performed again, and the alignment of the sensor and instrument assembly must be checked.

[0057] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A smart corneal lens / corneal flap separation device for corneal refractive surgery, characterized in that, include: Embedded hardware modules serve as the core control unit; A dual-degree-of-freedom force sensing module is electrically connected to the embedded hardware module and is used to acquire X-axis and Z-axis force signals during the separation process; The attitude sensing module is communicatively connected to the embedded hardware module and is used to collect the pitch and roll angle data of the instrument. The host computer communicates with the embedded hardware module to receive and process data; A dynamic compensation algorithm, integrated into the embedded hardware module, is used to eliminate force measurement errors caused by instrument tilt.

2. The intelligent corneal lens / corneal flap separation device according to claim 1, characterized in that, The dual-degree-of-freedom force sensing module includes two S-shaped load cells and a matching amplifier. The amplifiers are connected to the pins of the microcontroller, converting the raw voltage signal output by the sensor into a digital value via a 24-bit ADC. The raw force value is calculated using the following formula: ； Where k is the initial gain coefficient (default 0.63), and calibration_factor is obtained through offline calibration.

3. The intelligent corneal lens / corneal flap separation device according to claim 1, characterized in that, The attitude sensing module is a nine-axis IMU sensor, which transmits three-axis acceleration, angular velocity, and Euler angle data to the embedded hardware module via a Serial1 serial port; the data conversion formulas are as follows: Accelerometer conversion: ; Angular velocity conversion: ; Angle conversion: ; Among them, RAW Acc The raw acceleration value output by the sensor; RAW Gyro The original value of angular velocity, RAW Angle These are the original values ​​for Euler angles.

4. The intelligent corneal lens / corneal flap separation device according to claim 1, characterized in that, The dynamic compensation algorithm includes a two-stage compensation mechanism: Zero-point drift compensation: Triggered by a single pedal press, the current force sensor reading F is recorded. tare The IMU pitch angle θ1 and roll angle θ2 are used as reference values, and the reference values ​​are stored as Z. tareAngle [0]=θ1、Z tareAngle [1]=θ 2； Tilt force decoupling calculation: Based on the real-time attitude angle dynamic correction force sensor output, gravity component interference is eliminated. The decoupling formula is as follows: ； Where L0 and L1 are the raw values ​​of the force sensor, k0 and k1 are the calibration gain, Θ is the real-time angle of the IMU, and μ is the compensation offset.

5. The intelligent corneal lens / corneal flap separation device according to claim 1, characterized in that, It also includes a multi-point linear compensation calibration mode: calibration is triggered by three pedal presses, and the host computer sends the reference force value to the embedded hardware module; the system records the sensor's measured output and reference value at different angles, and generates a compensation table compForce[2][10][2]. The measured value of the X-axis in the compensation table is calculated as follows: calculate; X-axis reference value according to calculate; During runtime, the force output is corrected by looking up a table and using linear interpolation. The data error tolerance threshold is set to ±500mN, and data exceeding the threshold is automatically discarded.

6. The intelligent corneal lens / corneal flap separation device according to claim 1, characterized in that, The host computer is developed based on Qt and has the following functions: Dynamic plotting with dual Y-axis, where angle data is in degrees and force data is in mN; Data filtering automatically filters out abnormal data when the force value changes by more than 500mN; Data storage is performed in CSV format with timestamps, including timestamps, pitch angle, roll angle, X-axis force value, and Z-axis force value. The embedded hardware module sends CSV format data frames to the host computer via a serial port. The data frame format is [angle_pitch][\t][angle_roll][\t][Fx][\t][Fz].

7. The intelligent corneal lens / corneal flap separation device according to claim 1, characterized in that, The operating instructions for the device include: after the sensor is powered on, open the software; when holding the sensor handle, the hand should not touch the lower conical protrusion. Before use, calibrate the sensor using the pedal. During the calibration process, keep the sensor stationary and without pressure. When using the sensor probe tip to contact an object, the pressure applied should not exceed 1N to avoid damage to the sensor and excessive stress on the corneal tissue.

8. The intelligent corneal lens / corneal flap separation device according to claim 1, characterized in that, The embedded hardware module communicates with the host computer via serial port interaction, including a debug serial port and a dedicated sensor port, to avoid data conflicts. Alternatively, Bluetooth Low Energy transmission can be used to replace serial communication, eliminating cable constraints and adapting to sterile surgical environments.

9. The intelligent corneal lens / corneal flap separation device according to claim 1, characterized in that, Use modular design: The dual-degree-of-freedom force sensing module and attitude sensing module are replaceable modules that can be adapted to different types of surgical instruments. The embedded hardware module is designed with the joint unit interlocking part of the clamping force feedback surgical forceps, and can be bent to adapt to different surgical operation angle requirements.

10. The intelligent corneal lens / corneal flap separation device according to claim 1, characterized in that, It features fault-tolerant and robust design: The host computer is equipped with a real-time monitoring thread that checks the communication status with the embedded hardware module every 200ms. If the communication is interrupted and the timeout occurs, the serial port will be automatically restarted. The range of the collected data is limited, with the force value range being -1000mN to 1000mN and the angle value range being -360° to 360°. Data outside the range is judged as invalid data and discarded.

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