Electrosurgical equipment and working method thereof

Abstract

The invention discloses electrosurgical equipment and a working method thereof, the electrosurgical equipment comprises a host end and an instrument end, the instrument end comprises a jaw and a sensor module, the jaw is used for sealing tissue, and the sensor module comprises a Hall angle sensor and a pressure sensor; the host end comprises a closing detection module, an organization estimation module and a prediction engine; wherein the closing detection module is used for obtaining the current clamping tissue thickness Hcurrent and the current jaw clamping force Fcurrent of the electrosurgical equipment according to data detected by the Hall angle sensor and the pressure sensor; the tissue estimation module is used for judging the tissue type according to the current clamped tissue thickness Hcurrent and the current jaw clamping force Fcurrent; the prediction engine calculates the optimal excitation duration Tpred of the electrosurgical equipment according to a prediction model formula, the prediction model formula is Tpred = a * Hcurrent + b * Fcurrent + c * (Hcurrent * Fcurrent) + d, and in the formula, a, b, c and d are empirical coefficients obtained through experimental data fitting according to tissue types. According to the design of the invention, intelligent judgment and prompt of excitation duration and opportunity can be realized, and the operation precision and the safety and success rate of tissue cutting and sealing are improved.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to an electrosurgical device and its operating method. Background Technology

[0002] Bipolar or monopolar electrosurgical units are commonly used in laparoscopic surgery for tissue cutting and sealing, but existing generators mainly rely on preset power or tissue impedance feedback to adjust energy output. For example, the Medtronic Valleylab FT10... The technology automatically adjusts its output energy by monitoring tissue impedance changes 434,000 times per second to maintain a stable tissue effect. However, these systems do not sense the mechanical closure of the jaws, forcing surgeons to rely on visual perception and experience to judge the clamping effect and timing of excitation, which can easily lead to tissue carbonization, missed excitation, or incomplete sealing. Research has found that clamping pressure and tissue temperature are closely related to the effectiveness of energy application, and existing systems lack real-time feedback mechanisms, making it difficult to guarantee operational precision and surgical safety. Summary of the Invention

[0003] To solve the above-mentioned technical problems, the present invention provides the following technical solution:

[0004] An electrosurgical device includes a main unit and an instrument unit. The instrument unit includes an instrument and a sensor module, wherein the instrument is used to seal tissue, and the sensor module includes a Hall angle sensor and a pressure sensor. The main unit includes a closure detection module, a tissue estimation module, and a prediction engine. The closure detection module is used to obtain the current tissue thickness H held by the electrosurgical device based on data detected by the Hall angle sensor and the pressure sensor. current And the current clamping force F of the instrument jaws current The tissue estimation module is used to estimate the current clamped tissue thickness H. current And the current clamping force F of the instrument jaws current Determine tissue type; the prediction engine calculates the optimal excitation time T for the electrosurgical device based on the prediction model formula. pred The prediction model formula is: T pred =a·H current +b·F current +c·(H current ·F current In the formula )+d, a, b, c, and d are empirical coefficients obtained by fitting experimental data based on tissue type.

[0005] Furthermore, a, b, c, and d are also related to the excitation power of the electrosurgical equipment, with different excitation powers corresponding to different a, b, c, and d.

[0006] Furthermore, a Hall angle sensor is mounted at the jaw pivot of the instrument to obtain an analog signal V of the opening angle.angle A pressure sensor is mounted on the handle drive rod or jaw base of the electrosurgical device to obtain an analog signal V of the jaw clamping force. force .

[0007] Furthermore, the closure detection module converts the analog signal obtained by the sensor into a physical quantity, specifically, by V. angle The linear transformation yields the instrument jaw opening angle θ, and the current tissue thickness H is obtained using the following formula. current H current = 2·L·sin(θ / 2), where L is the jaw length; V force Converting to Newtons (N), we obtain the current clamping force F of the instrument jaws. current .

[0008] Furthermore, the electrosurgical device also includes a safety triggering determination module, which determines the triggering based on the current tissue thickness H being held. current And the current clamping force F of the instrument jaws current Determine if the activation conditions are met. If the safe activation determination module determines that it is abnormal, a prompt will be issued.

[0009] Furthermore, the electrosurgical device includes a user interface that displays information such as the ability to modify the excitation power, whether excitation conditions are met and the reasons for not meeting them, the optimal excitation duration, and, after the operator triggers the start excitation signal, the optimal excitation duration counts down to provide feedback to the user on the remaining time.

[0010] Furthermore, the electrosurgical device also includes an audio component to indicate when stimulation is complete or abnormal.

[0011] Furthermore, the workflow of the electrosurgical device is as follows:

[0012] a. Upon powering on, the default user interface is displayed, allowing the user to set the excitation power.

[0013] b. The instrument end of the electrosurgical device closes the tissue. Once closure is complete, the instrument jaws hold the tissue.

[0014] c. Read the jaw opening angle and clamping force. Based on the jaw opening angle, clamping force and the excitation power set by the user, determine whether excitation is possible. If the excitation conditions are met, proceed to step d. If the excitation conditions are not met, analyze the reasons and display the feedback on the user interface. Open the jaws, reselect the tissue site, and return to step b.

[0015] d. Calculate the optimal excitation time using the predictive model formula;

[0016] e. Send an excitation signal to update the user interface, start the countdown for the predicted time, and provide an audio prompt;

[0017] f. Determine if the user interrupts the operation. If the operation is interrupted, stop the countdown and sound prompts, and wait for the user to trigger it again. If the user does not open the jaws, return to step e. If the user opens the jaws, hide the prediction time interface and display the default user interface. This operation ends. If the operation is not interrupted, play the completion prompt sound until the countdown ends. Determine if the expected effect is achieved. If the expected effect is achieved, end this operation. If the expected effect is not achieved, return to step c.

[0018] With this design, the present invention has at least the following advantages:

[0019] 1. It enables intelligent judgment and prompting of excitation duration and timing, improving operational accuracy and the safety and success rate of tissue cutting and sealing;

[0020] 2. Provides a human-computer interaction user interface to assist doctors in completing the stimulation process, making it easy to operate;

[0021] 3. It has a simple structure, low cost, and is easy to implement. Attached Figure Description

[0022] The above is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0023] Figure 1 This is a schematic diagram of the electrosurgical device of the present invention;

[0024] Figure 2 This is a schematic diagram of the working process of the electrosurgical device of the present invention. Detailed Implementation

[0025] The technical solutions of 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 of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0026] An electrosurgical device includes a host unit and an instrument unit. The host unit includes hardware and an application program that implements corresponding functions. The host unit controls the instrument unit to achieve tissue closure. The instrument unit includes an instrument and a sensor module. The instrument is used to close the tissue, and the sensor module includes a Hall angle sensor and a pressure sensor. The host unit includes a closure detection module, a tissue estimation module, and a prediction engine. The closure detection module is used to obtain the current tissue thickness H held by the electrosurgical device based on the data detected by the Hall angle sensor and the pressure sensor. current And the current clamping force F of the instrument jaws current The tissue estimation module is used to estimate the current clamped tissue thickness H. current And the current clamping force F of the instrument jaws current Determine tissue type; the prediction engine calculates the optimal excitation time T for the electrosurgical device based on the prediction model formula. pred The prediction model formula is: T pred =a·H current +b·F current +c·(H current ·F current In the formula )+d, a, b, c, and d are empirical coefficients obtained by fitting experimental data based on tissue type.

[0027] Furthermore, a, b, c, and d are also related to the excitation power of the electrosurgical equipment. Different excitation powers correspond to different a, b, c, and d. When operating, the operator can select the appropriate excitation power according to the actual situation, thereby calling the appropriate prediction model formula.

[0028] This application does not rely on complex biothermodynamic theories and formulas; the predictive model formula is obtained using an "offline calibration-online lookup / fitting" method. During the research and development phase, numerous in vitro and in vivo animal experiments were conducted to record the actual excitation time required to achieve the optimal sealing effect (i.e., complete tissue denaturation without excessive carbonization) under different tissue thicknesses and clamping pressures. Using this experimental data, a predictive model was established using polynomial regression, assuming that the optimal excitation time is a function of tissue thickness and clamping force, thus obtaining the predictive model formula. In practical operation, the tissue type is determined based on tissue thickness and clamping pressure, and appropriate formulas a, b, c, and d are called according to different types.

[0029] Furthermore, a Hall angle sensor is mounted at the jaw pivot of the instrument to obtain an analog signal V of the opening angle. angle A pressure sensor is mounted on the handle drive rod or jaw base of the electrosurgical device to obtain an analog signal V of the jaw clamping force. force .

[0030] The closure detection module converts the analog signal obtained by the sensor into a physical quantity, specifically, by V.angle Linear transformation yields the instrument jaw opening angle θ, from which tissue thickness H is obtained using the following formula. current H current = 2·L·sin(θ / 2), where L is the jaw length; V force Converting to Newtons (N) yields the current clamping force F. current .

[0031] The tissue estimation module estimates the current clamped tissue thickness H. current And the current clamping force F of the instrument jaws current To determine the type of tissue currently being clamped, the tissue can be the intestine, stomach, blood vessels, etc. Because different tissues have different hardness, the clamping force will vary at the same thickness. The clamping force is determined based on the current tissue thickness H. current And the current clamping force F of the instrument jaws current It can determine the type of organization, thereby selecting the appropriate corresponding a, b, c, d, and calling the appropriate prediction model formula.

[0032] Furthermore, the electrosurgical device also includes a safety triggering determination module, which determines the triggering based on the current tissue thickness H being held. current And the current clamping force F of the instrument jaws current The system determines whether the activation conditions are met. If the safety activation judgment module determines an abnormality, it issues a warning. Abnormalities include excessively thick tissue, foreign objects / abnormal hardness, and insufficient pressure. The safety activation judgment module is an "electronic fence" based on physical thresholds. Its core logic is a "conditional veto system." The electrosurgical equipment has preset safe operating windows for specific instruments, thereby avoiding damage to tissues and the electrosurgical equipment.

[0033] Specifically, for tissues with excessive thickness, the maximum permissible closure thickness H is set according to the instrument specifications of the electrosurgical equipment. max If H current >H max The electrosurgical device's system determines that there is "jaw overload" or "contains non-target tissue (such as large muscle)". In this case, the electrosurgical device prohibits stimulation and prompts "Tissue too thick, please reduce the amount".

[0034] For foreign body / hardness abnormality detection, in practice, simply looking at the thickness is insufficient; it's also necessary to consider pressure to determine if a hard foreign object (such as a titanium clip, bone, or other tissue) is trapped. For example, when closing a blood vessel, because the vessel is soft tissue, its compression ratio is high, while foreign objects or dense tissue have a low compression ratio. The current equivalent stiffness K = F is calculated. current / H current When the jaws of the electrosurgical device close to a specific thickness, pressure F... current Far exceeding the typical pressure range corresponding to a blood vessel of that thickness (e.g., exceeding F).limit This indicates that the object being held is not simply a blood vessel, but may be a rigid foreign body (such as a titanium clip, bone) or other tissue. In this case, the electrosurgical device should not be activated and a message should be displayed: "Object holding abnormal / Foreign body under inspection".

[0035] Regarding insufficient pressure, if F current <F min， Where F min The minimum threshold pressure for a specific thickness indicates insufficient compaction and poor sealing. In this case, the electrosurgical device may allow activation but will issue a yellow warning or prohibit activation with the message "Please press the handle firmly."

[0036] Furthermore, the electrosurgical device includes a user interface that displays information such as the ability to modify the excitation power, whether excitation conditions are met and the reasons for not meeting them, the optimal excitation duration, and, after the operator triggers the start excitation signal, the optimal excitation duration counts down to provide feedback to the user on the remaining time.

[0037] Furthermore, electrosurgical devices also include sound components to indicate when stimulation is complete or abnormal.

[0038] The electrosurgical device operates as follows:

[0039] a. Upon powering on, the default user interface is displayed, allowing the user to set the excitation power.

[0040] b. The instrument end of the electrosurgical device closes the tissue. Once closure is complete, the instrument jaws hold the tissue.

[0041] c. Read the jaw opening angle and clamping force. Based on the jaw opening angle, clamping force, and user-set excitation power, determine whether excitation is possible. If the excitation conditions are met, proceed to step d. If the excitation conditions are not met, analyze the reasons and display the feedback on the user interface. Open the jaws, reselect the tissue site, and return to step b. Reasons for not being able to excite include: excessive clamping force causing hard objects or other tissues to be trapped, excessive opening angle resulting in excessively thick tissue, etc.

[0042] d. Calculate the optimal excitation time using the predictive model formula;

[0043] e. Send an excitation signal to update the user interface, start the countdown for the predicted time, and provide an audio prompt;

[0044] f. Determine if the user interrupts the operation. If the operation is interrupted, stop the countdown and sound prompts, and wait for the user to trigger it again. If the user does not open the jaws, return to step e. If the user opens the jaws, hide the prediction time interface and display the default user interface. This operation ends. If the operation is not interrupted, play the completion prompt sound until the countdown ends. Determine if the expected effect is achieved. If the expected effect is achieved, end this operation. If the expected effect is not achieved, return to step c.

[0045] In summary, this application provides an electrosurgical device and its working method based on a real-time feedback system for instrument closure parameters. It intelligently determines whether energy excitation is suitable by collecting parameters such as the instrument jaw closure angle and clamping force, combined with tissue state prediction, and provides real-time feedback through a user interface or sound.

[0046] By adopting this design, the following effects can be achieved:

[0047] 1. It can monitor the clamping status of the instrument jaws in real time and provide operation suggestions to reduce the risk of premature or delayed activation, and improve sealing quality and operation efficiency.

[0048] 2. Predict the energy required for stimulation and the time required, and provide a human-computer interaction user interface to assist doctors in completing the stimulation process.

[0049] 3. Reduce unnecessary repeated stimulation or examination procedures, making the surgical process more coherent and avoiding the common "repeated clamping-stimulation" cycle; the system is compatible with existing electrosurgical equipment platforms and is easy to promote in clinical practice.

[0050] 4. It can collaborate with robotic systems to achieve intelligent control of closure force and automatic decision-making on energy release, thus promoting automated and refined surgery.

[0051] 5. Provides intuitive operation suggestions and real-time feedback for beginners. Novices can master the correct clamping force and timing of activation based on system prompts, accelerate experience accumulation, and shorten the training cycle.

[0052] Other embodiments of the invention will readily conceive of those skilled in the art upon consideration of the invention disclosed in the specification and embodiments. This application is intended to cover any variations, uses, or adaptations of the invention that follow the general principles of the invention and include common knowledge or customary techniques in the art not disclosed herein. The specification and embodiments are to be considered exemplary only, and the true scope and spirit of the invention are indicated by the following claims.

[0053] It should be understood that the present invention is not limited to the precise structure described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of the invention is limited only by the appended claims.

Claims

1. An electrosurgical apparatus comprising a host end and an instrument end, the instrument end comprising an instrument and a sensor module, wherein, The instrument is used to seal tissue. The sensor module includes a Hall angle sensor and a pressure sensor. The main unit includes a closure detection module, a tissue estimation module, and a prediction engine. The closure detection module determines the current tissue thickness H held by the electrosurgical device based on data from the Hall angle sensor and pressure sensor. current and the current clamping force F of the instrument jaws current The tissue estimation module is used to estimate the current clamped tissue thickness H. current and the current clamping force F of the instrument jaws current Determine tissue type; the prediction engine calculates the optimal excitation time T for the electrosurgical device based on the prediction model formula. pred The prediction model formula is: T pred = a · H current + b · F current + c · (H current · F current ) + d, In the formula, a, b, c, d: are empirical coefficients fitted by experimental data according to tissue type.

2. The electrosurgical apparatus of claim 1, wherein, a, b, c, d are also related to the excitation power of the electrosurgical device, and different excitation powers correspond to different a, b, c, d.

3. The electrosurgical apparatus of claim 1, wherein the first and second electrodes are configured to be positioned on opposite sides of the tissue site. A Hall angle sensor is mounted at the instrument jaw pivot for obtaining an open angle analog signal V angle A pressure sensor is mounted at the electrosurgical instrument handle drive rod or jaw base for obtaining a jaw clamp force analog signal V force .

4. The electrosurgical apparatus of claim 3, wherein the first and second electrodes are configured to be positioned on opposite sides of the tissue site. The closure detection module converts the analog signal obtained by the sensor into a physical quantity, specifically, the V angle The linear conversion derives the instrument jaw opening angle θ, the current clamped tissue thickness H is obtained by the following formula current : H current = 2 L sin(0 / 2), where L is the length of the jaw. V force Convert to Newtons (N) to get the current instrument jaw clamping force F current .

5. Electrosurgical apparatus according to any one of claims 1 to 4, wherein, The electrosurgical apparatus also includes a safe firing decision module that determines whether a firing condition is met based on a current clamped tissue thickness H current and a current instrument jaw clamping force F current and issues a prompt if the safe firing decision module determines that an anomaly exists.

6. The electrosurgical apparatus of claim 5, wherein the first and second electrodes are configured to be positioned on opposite sides of the tissue site. The electrosurgical device also has a sound component for prompting the completion of excitation and excitation abnormalities.

7. The working method of the electrosurgical device according to any one of claims 1-6, characterized in that, a. Turn on and display the default user interface, the user can set the excitation power through the user interface; b. Close the tissue with the instrument end of the electrosurgical device, and when the closure is complete, the instrument jaw clamps the tissue; c. Read the jaw opening angle and clamping force, and determine whether excitation can be performed through the jaw opening angle, clamping force, and user-set excitation power. If the excitation conditions are met, proceed to step d. If the excitation conditions are not met, analyze the reasons and display the feedback on the user interface, open the jaw, and reselect the tissue site, returning to step b; d. Calculate the optimal excitation time through the prediction model formula; e. Send the excitation signal, update the user interface, start the countdown of the prediction time, and provide an audible prompt; f. Determine whether the user has interrupted the operation. If the operation is interrupted, stop the countdown and audible prompt, wait for the user to excite again, and if the user does not open the jaw, return to step e. If the user opens the jaw, hide the prediction time interface, display the default user interface, and end the operation. If the operation is not interrupted, wait until the countdown is complete, play a completion prompt, determine whether the desired effect has been achieved, and if the desired effect has been achieved, end the operation. If the desired effect has not been achieved, return to step c. ​

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