Vocal cord dynamic closing process mechanical track evaluation system

Abstract

The invention relates to a vocal cord dynamic closing process mechanical track evaluation system, which belongs to the technical field of medical instruments and comprises a disposable probe assembly, a handheld signal processing handle and a data analysis and display host. The far end of the disposable probe assembly is provided with a wedge-shaped double-slope sensing head, the near end of the disposable probe assembly is provided with a multi-dimensional sensing module and a waterproof electrical interface, and the disposable probe assembly is used for collecting mechanical and motion signals in the vocal cord closing process. The hand-held signal processing handle is connected with the probe assembly, and a signal processing circuit is arranged in the hand-held signal processing handle and is responsible for signal acquisition and wireless transmission. And the data analysis and display host receives and processes the signal, generates a trajectory diagram reflecting the dynamic closing mechanical characteristics of the vocal cords on the two sides through motion compensation, time sequence recognition and inclined plane mechanical calculation, and synchronously displays the trajectory diagram and a throat image. The system can realize direct, in-vivo and quantitative measurement of mechanical characteristics in the whole vocal cord closing process, and provides an objective and dynamic mechanical basis for throat muscle function evaluation.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology and relates to a system for evaluating the mechanical trajectory of the dynamic closure process of the vocal cords. Background Technology

[0002] In the fields of laryngology and voice medicine, accurate assessment of laryngeal muscle function is crucial for diagnosing conditions such as vocal cord paralysis, laryngeal dystonia, and vocal cord sulcus, as well as for developing surgical plans and evaluating rehabilitation outcomes. The intralarynx muscles, as the direct executors of vocal cord movement and regulation of glottal closure and tension, directly determine the quality of phonation, respiration, and airway protection. Currently, clinical assessment primarily relies on three techniques: laryngoscopy (including stroboscopic laryngoscopy), laryngeal electromyography, and aerodynamic testing. While these techniques provide diagnostic information from different perspectives, they all have inherent and insurmountable limitations.

[0003] Laryngoscopy, as the most direct morphological observation method, allows doctors to observe the color, shape, movement, and closure phase of the vocal cords in real time, forming the basis of voice assessment. However, it is essentially a subjective visual evaluation, unable to translate the tightness of vocal cord closure, contact pressure, and mechanical differences in bilateral vocal cord movement into objective, quantifiable data. Doctors can only rely on experience to judge whether the vocal cords are in "mild contact" or "strong adduction." For unilateral vocal cord paralysis, only abnormal vocal cord position and closure gaps can be observed, but the compensatory excessive adduction force of the healthy vocal cord and the residual tension of the affected vocal cord cannot be precisely quantified. This makes the selection of the force for surgical interventions (such as vocal cord injections or laryngeal frame surgery) lack precise objective basis. Laryngeal electromyography records the electrical activity of muscles through needle electrodes, aiming to assess the integrity of nerve innervation. Although it can distinguish between neurogenic and myogenic lesions, it is an invasive procedure with poor patient tolerance, and it measures bioelectrical signals rather than the mechanical force ultimately generated by muscle contraction. Electrical excitation of nerves does not equate to effective mechanical output from muscles, especially in cases of muscle atrophy or fibrosis, where electrical signals and mechanical function become severely disconnected. Therefore, electromyography (EMG) cannot accurately reflect the actual motor capacity and closure strength of the vocal cords. Aerodynamic testing indirectly infers glottal closure efficiency by measuring parameters such as average airflow rate, maximum phonation time, and subglottic pressure during phonation. These indicators reflect the overall effectiveness of the vocal system, but they cannot determine which side of the vocal cord is causing the abnormality, nor can they distinguish between glottal morphology issues (such as gaps) and vocal cord tension problems. For example, the same airflow rate may originate from bilateral hemiplegia or unilateral paralysis with strong contralateral compensation, leading to drastically different clinical decision-making pathways. Aerodynamic data cannot provide this crucial information for differentiation.

[0004] In summary, existing technologies constitute a "functional assessment blind spot": they may provide morphological "visual snapshots," electrophysiological "neural reports," or systemic "efficiency integrals," but none can directly, in vivo, and quantitatively capture and depict the mechanical evolution trajectory and bilateral coordination details of the vocal cords' dynamic movement from opening to closing. This leads clinicians, when faced with functional disorders such as vocal cord paralysis, to infer the engine's output power and the balance of two-wheel drive by merely observing a car's appearance and circuit diagram, unable to perform real-time "chassis dynamometer testing." This lack of dynamic process mechanical information severely restricts the refined diagnosis of laryngeal functional diseases, the precise design of personalized surgical plans, and the objective quantitative evaluation of postoperative rehabilitation efficacy, representing a critical technological bottleneck urgently needing a breakthrough in current laryngology and voice medicine clinical practice. Summary of the Invention

[0005] In view of this, the purpose of this invention is to propose a dynamic mechanical trajectory evaluation system for the vocal cord closure process. This system utilizes a disposable probe assembly consisting of a wedge-shaped double-inclined sensor head with a specific geometric structure, a multi-dimensional sensing module integrated within the probe, and a handheld handle with signal processing circuitry. Combined with a data analysis and display host for motion compensation, timing recognition, inclined mechanical calculation, and multi-dimensional trajectory generation, this system addresses the problems in existing technologies where laryngoscopes only provide morphological observation and cannot quantify mechanical parameters, laryngeal electromyography is invasive and suffers from electrical-mechanical signal disconnection, and aerodynamic testing cannot analyze the dynamic coordination process of both vocal cords. These issues result in a lack of direct, objective, and dynamic mechanical quantitative evidence for laryngeal muscle function evaluation.

[0006] To achieve the above objectives, the present invention provides the following technical solution:

[0007] A vocal cord dynamic closure process mechanical trajectory evaluation system includes a disposable probe assembly, a handheld signal processing handle, and a data analysis and display host. The distal end of the disposable probe assembly is fixedly equipped with a wedge-shaped double-bevel sensing head, and the proximal end is fixedly equipped with a waterproof electrical interface. The front end of the handheld signal processing handle is fixedly equipped with a connection interface, and the waterproof electrical interface of the disposable probe assembly is detachably connected to the connection interface of the handheld signal processing handle. The handheld signal processing handle is communicatively connected to the data analysis and display host. The wedge-shaped double-bevel sensing head includes a left sensing bevel and a right sensing bevel, which intersect to form a apex angle. A multi-dimensional sensing module is fixedly installed inside the disposable probe assembly, and the multi-dimensional sensing module is electrically connected to the waterproof electrical interface. A signal processing circuit is fixedly installed inside the handheld signal processing handle, and the signal processing circuit is electrically connected to the connection interface.

[0008] Furthermore, the multidimensional sensing module includes a force sensing unit and a motion sensing unit; the force sensing unit is a two-dimensional force sensor; and the motion sensing unit is an inertial measurement unit.

[0009] Furthermore, the signal processing circuit includes a microcontroller, an analog front-end, and a wireless transmission module; the input terminal of the analog front-end is connected to the waterproof electrical interface through the connection interface; the output terminal of the analog front-end is connected to the microcontroller; the wireless transmission module is connected to the microcontroller; and the wireless transmission module is communicatively connected to the data analysis and display host.

[0010] Furthermore, it also includes an imaging device; the data analysis and display host is communicatively connected to the imaging device and is used to receive throat images acquired by the imaging device.

[0011] Furthermore, the imaging device is a separate laryngoscope.

[0012] Furthermore, the data analysis and display host includes a motion compensation module, a timing recognition module, a mechanics calculation module, and a trajectory generation module;

[0013] The motion compensation module is used to calculate the motion of the disposable probe assembly based on the data from the motion sensing unit, and to compensate for the mechanical signals detected by the force sensing unit.

[0014] The timing recognition module is used to identify the first starting time of contact between the left vocal cord and the left sensing inclined plane, and the second starting time of contact between the right vocal cord and the right sensing inclined plane, based on the compensated mechanical signal.

[0015] The mechanical calculation module is used to calculate the left normal force and left tangential force acting on the left sensing inclined plane, and the right normal force and right tangential force acting on the right sensing inclined plane, based on the compensated force signal according to the inclined plane mechanical model.

[0016] The trajectory generation module generates and displays a dynamic closure mechanical trajectory diagram of the vocal cords, including the curves of the left normal force, the right normal force, the left tangential force, and the right tangential force changing over time.

[0017] Furthermore, the data analysis and display host is also used to synchronously overlay and display the dynamic closure mechanical trajectory diagram of the vocal cords and the laryngeal image.

[0018] Furthermore, the surfaces of the left sensing slope and the right sensing slope are provided with micro-textured structures.

[0019] The beneficial effects of this invention are as follows:

[0020] This invention achieves direct, in vivo, and quantitative measurement of the mechanical properties of the entire vocal cord closure process by using a disposable probe assembly with a specific geometric configuration of a passive wedge-shaped sensing head and an integrated multidimensional sensing module, combined with a data analysis system capable of performing high-precision signal processing and dynamic mechanical calculations. This approach elevates the assessment of laryngeal muscle function from subjective morphological observation to a quantifiable level of dynamic mechanical analysis, filling a clinical gap in the lack of mechanical information during vocal cord movement. Its simple structure and convenient operation facilitate seamless integration into routine laryngoscopy, significantly reducing technical barriers and operational dependence. The generated multidimensional mechanical trajectory diagram provides unprecedented quantitative evidence for the accurate diagnosis of vocal cord paralysis, dystonia, and other diseases, the development of personalized surgical plans, and the objective evaluation of rehabilitation efficacy, significantly improving the objectivity, accuracy, and clinical guidance value of laryngeal functional assessment.

[0021] Other advantages, objectives, and features of the invention will be set forth in part in the description which follows, and in part will be apparent to those skilled in the art from the following examination, or may be learned from practice of the invention. The objectives and other advantages of the invention can be realized and obtained through the following description. Attached Figure Description

[0022] To make the objectives, technical solutions, and advantages of the present invention clearer, the preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings, wherein:

[0023] Figure 1 This is a structural diagram of the present invention;

[0024] Figure 2 This is a structural diagram of the handheld part;

[0025] Figure 3 This is a front view of the overall structure of the handheld part;

[0026] Figure 4 This is a side view of the overall structure of the handheld part;

[0027] Figure 5 This is a top view of the overall structure of the handheld part;

[0028] Figure 6 This is a cross-sectional view of the overall structure of the handheld part;

[0029] Figure 7 This is a partial cross-sectional view of a disposable probe assembly.

[0030] Reference numerals: 1. Disposable probe assembly; 2. Handheld signal processing handle; 3. Data analysis and display host; 4. Wedge-shaped double-bevel sensor head; 5. Waterproof electrical interface; 6. Left sensing bevel; 7. Right sensing bevel; 8. Multidimensional sensing module; 9. Force sensing unit; 10. Motion sensing unit; 11. Connection interface; 12. Signal processing circuit; 13. Microcontroller; 14. Analog front end; 16. Electronic laryngoscope; 17. Probe rod; 18. Miniature shielded cable. Detailed Implementation

[0031] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the following embodiments are only schematic representations of the basic concept of the present invention. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0032] The accompanying drawings are for illustrative purposes only and are schematic diagrams, not actual pictures. They should not be construed as limiting the invention. To better illustrate the embodiments of the invention, some parts in the drawings may be omitted, enlarged, or reduced, and do not represent the actual product dimensions. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings.

[0033] In the accompanying drawings of the embodiments of the present invention, the same or similar reference numerals correspond to the same or similar components. In the description of the present invention, it should be understood that if terms such as "upper," "lower," "left," "right," "front," and "rear" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, they are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, the terms used to describe positional relationships in the drawings are only for illustrative purposes and should not be construed as limiting the present invention. For those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0034] like Figure 1-7 As shown, the zonal pressure-adjustable cold compress fixation device for post-botulinum toxin treatment provided by this invention comprises a disposable probe assembly 1, a reusable handheld signal processing handle 2, and a data analysis and display host 3 serving as a computing and interactive terminal. These three modules work collaboratively through mechanical interfaces, electrical connections, and wireless communication to jointly achieve high-precision quantitative evaluation of the dynamic closure mechanical properties of the vocal cords.

[0035] The disposable probe assembly 1, as the front-end sensor unit of the system, is directly related to the reliability of signal acquisition and measurement accuracy. This assembly is manufactured using multi-layered material composites and precision injection molding processes to ensure it possesses sufficient flexibility to pass through the convoluted throat passage while maintaining a stable geometry at the distal end.

[0036] The distal end of the disposable probe assembly 1 is a key functional component – ​​the wedge-shaped dual-bevel sensor head 4. The wedge-shaped dual-bevel sensor head 4 is integrally injection molded from a biocompatible medical-grade polymer material (such as polyurethane or silicone) using a precision mold. Its core geometric feature is the wedge-shaped body formed at a specific angle at its end. This wedge-shaped body contains two main functional surfaces: a left sensing bevel 6 and a right sensing bevel 7. The left sensing bevel 6 and the right sensing bevel 7 intersect at the tip of the probe, forming a apex angle. This apex angle is optimized so that when placed in the glottis region, the left sensing bevel 6 naturally faces the patient's left vocal cord, and the right sensing bevel 7 faces the right vocal cord. The surfaces of the left sensing ramp 6 and the right sensing ramp 7 are not smooth, but are etched with fine micro-texture structures by the mold during injection molding. The function of this micro-texture structure is to increase the friction coefficient between the ramp and the moist vocal cord mucosa, ensuring that a sufficiently significant and stable tangential friction force signal can be generated when the vocal cord closes and slides over the ramp. This is crucial for the subsequent calculation of the vocal cord movement speed.

[0037] The proximal end of the wedge-shaped double-bevel sensor head 4 is seamlessly connected to the slender probe shaft 17 via a transition structure. The probe shaft 17 is also made of flexible medical material and has a continuous internal cavity. The flexibility of the probe shaft 17 ensures that it conforms to the natural curvature of the laryngoscope working channel or the pharynx without affecting the positioning of the distal wedge-shaped double-bevel sensor head 4. The surface of the probe shaft 17 is coated with a hydrophilic lubricating coating to minimize tissue friction and patient discomfort during insertion.

[0038] Inside the proximal end of the probe shaft 17, a multi-dimensional sensing module 8 is securely encapsulated using a secondary encapsulation injection molding process. The multi-dimensional sensing module 8 is an assembly of microelectronic components, its core being a custom-designed micro-flexible printed circuit board. On this flexible printed circuit board, two main sensing chips are precisely soldered using surface mount technology: one is a force sensing unit 9, specifically a microelectromechanical system (MEMS) two-dimensional force sensor chip, whose two sensitive sensing axes are set to measure the forces acting on the probe in the left-right direction (defined as the X-axis) and the front-back direction (defined as the Y-axis), respectively; the other is a motion sensing unit 10, specifically a six-axis inertial measurement unit chip, which integrates a three-axis accelerometer and a three-axis gyroscope for high-frequency measurement of the probe's linear acceleration and rotational angular velocity in three-dimensional space. The mounting positions of these two chips are carefully designed so that their sensitive centers are as close as possible to the point of mechanical action of the wedge-shaped double-sloping surface sensing head 4 to reduce signal distortion caused by mechanical transmission.

[0039] The multidimensional sensing module 8 is connected via an extremely thin wire to a multi-core miniature shielded cable 18 integrated within the cavity of the probe shaft 17. The miniature shielded cable 18 extends rearward along the internal cavity of the probe shaft 17, ultimately terminating at the very end of the disposable probe assembly 1—the waterproof electrical interface 5. The waterproof electrical interface 5 is a miniaturized standard medical connector with a housing made of rigid engineering plastic and multiple gold-plated flexible electrical contact pins embedded within. Each core of the miniature shielded cable 18 is individually soldered to its corresponding electrical contact pin. The housing of the waterproof electrical interface 5 and the flexible probe shaft 17 are injection-molded together to form a reliable mechanical connection and a liquid-tight seal, ensuring that the internal circuitry will not short-circuit due to moisture when in contact with human tissue fluid. The design of the waterproof electrical interface 5 allows for quick plug-and-play connection to the handheld signal processing handle 2, and a secure locking mechanism after connection.

[0040] The handheld signal processing handle 2 is the central hub for human-computer interaction and control. Its shell design conforms to ergonomics, making it easy for doctors to hold and operate with one hand.

[0041] At the front end of the handle housing, a connection interface 11 is fixedly installed, which is fully compatible with the waterproof electrical interface 5. The connection interface 11 has a corresponding socket and resilient contacts, enabling precise electrical conduction when the waterproof electrical interface 5 of the disposable probe assembly 1 is inserted. The connection interface 11 is typically designed with a rotating locking collar or snap-fit ​​mechanism to provide additional mechanical locking after insertion, preventing accidental dislodgement during operation.

[0042] The handle's casing houses a highly integrated signal processing circuit 12. At the core of this circuit is a multi-layer printed circuit board. On this board, a microcontroller 13 is integrated, serving as the "brain" of the entire handle and coordinating the timing of all functional units. Directly connected to the microcontroller 13 is an analog front-end 14, a functional module specifically designed to process weak analog signals. The analog front-end 14 receives the raw analog voltage signal output from the force sensing unit 9 in the disposable probe assembly 1 via a connection interface 11. The analog front-end 14 internally includes a low-noise instrumentation amplifier, a programmable gain amplifier, and a high-resolution analog-to-digital converter. Its workflow involves amplifying the microvolt-level raw force signal and then converting it into a digital signal. The gain, sampling rate, and other parameters of the analog front-end 14 are controlled by the microcontroller 13 through a digital interface.

[0043] Meanwhile, the signal processing circuit 12 is also equipped with a digital interface (such as SPI or I2C) for communicating with the motion sensing unit 10. The microcontroller 13 directly reads the raw digital acceleration and angular velocity data output by the inertial measurement unit chip through this interface.

[0044] To transmit the collected data to the data analysis and display host 3 in real time, a wireless transmission module, such as a chip based on Bluetooth 5.0 or Wi-Fi protocols, is also integrated on the signal processing circuit 12. The microcontroller 13 packages the digital force signal from the analog front end 14 and the inertial data from the motion sensing unit 10 into specific data frames and sends them out through the wireless transmission module.

[0045] The entire signal processing circuit 12 is powered by a built-in rechargeable lithium battery and a corresponding power management unit. The power management unit not only powers the chip inside the handle but also provides a stable and clean operating voltage to the multi-dimensional sensing module 8 of the disposable probe assembly 1 via the connection interface 11. The handle shell is typically equipped with a power switch, a battery status indicator, a wireless connection indicator, and one or more function buttons, such as a "marker button," for manually marking times during data acquisition to identify specific events (such as the start of a specific sound-emitting task).

[0046] The data analysis and display host 3 is typically a high-performance computer, laptop, or dedicated workstation that runs specialized analysis software developed for this system.

[0047] The handheld signal processing handle 2 establishes a stable wireless data link with the data analysis and display host 3 through its wireless transmission module, and continuously transmits the collected multi-channel sensor data stream to the host.

[0048] To combine the biomechanical measurements with traditional laryngeal morphology observation, the system requires an imaging device. In this embodiment, the imaging device is a standalone electronic laryngoscope 16, a standard clinical device. The electronic laryngoscope 16 inputs its acquired real-time video signal via a video cable (such as HDMI or USB) to the video capture card or USB interface of the data analysis and display host 3. The dedicated software of the data analysis and display host 3 can thus simultaneously acquire two data streams: one is the biomechanical and kinematic data stream from the handle, and the other is the video stream from the electronic laryngoscope 16. The software uses a high-precision time synchronization algorithm to ensure that each frame of video is precisely aligned with the corresponding sensor data.

[0049] The specific operation and data processing flow of this embodiment is as follows. This flow clearly demonstrates the complete closed loop from equipment preparation to result interpretation, as well as how each component cooperates precisely at different stages.

[0050] Step 1: System Initialization and Probe Positioning

[0051] Hardware Connection: Remove the disposable probe assembly 1 from the aseptic packaging, align its waterproof electrical interface 5 with the connection interface 11 at the front of the handheld signal processing handle 2, insert and rotate the locking ring. A "click" sound indicates that the mechanical and electrical connections are complete. At this point, the handle begins to power the probe, and the multidimensional sensing module 8 on the probe enters the working state.

[0052] Powering on and pairing the device: Turn on the power switch of the handheld signal processing handle 2; its status indicator light will illuminate. Start the data analysis and display host 3 and run the dedicated analysis software. The software will automatically search for and connect to the handle's wireless transmission module, establishing a communication link. Simultaneously, connect the video output cable of the electronic laryngoscope 16 to the host's video input port.

[0053] Patient preparation and probe insertion: The patient is seated or supine, and topical anesthesia of the oropharynx is administered. The operator (doctor) holds the electronic laryngoscope 16 in their left hand and inserts it through the mouth until the glottic structure is clearly visible on the monitor.

[0054] Key positioning procedure: The operator holds the handheld signal processing handle 2 with the probe attached in their right hand and slowly inserts the disposable probe assembly 1 along the working channel on the side of the electronic laryngoscope 16 (or close to the laryngoscope rod if no dedicated channel is available) until the wedge-shaped double-bevel sensor head 4 appears above the glottis in the image of the electronic laryngoscope 16. By finely adjusting the angle and depth of the handle, the wedge-shaped double-bevel sensor head 4 is finally stably positioned at the anterior commissure of the glottis. This position is a fixed anatomical landmark. The correct positioning criteria are: the tip of the wedge-shaped double-bevel sensor head 4 gently abuts or is very close to the anterior commissure mucosa, its left sensing bevel 6 faces the left vocal cord in the image (the patient's right side), its right sensing bevel 7 faces the right vocal cord (the patient's left side), and the probe rod 17 is basically parallel to the glottic axis. The accuracy of this step is crucial, as it ensures that all subsequent mechanical signals have a consistent anatomical reference.

[0055] Step 2: Synchronous Data Acquisition and Signal Transmission

[0056] Software Setup and Synchronization Trigger: On the software interface of the data analysis and display host 3, set the sampling parameters (e.g., set the sampling rate to 10kHz) and click the "Start Recording" button. The software will simultaneously issue two commands: one is to notify the handheld signal processing handle 2 to start high-speed data acquisition via wireless link; the other is to start recording the video stream input by the electronic laryngoscope 16. The software internally uses a high-precision clock to assign a unified timestamp to these two data streams, achieving millisecond-level synchronization.

[0057] Subject vocalization and data generation: Patients were instructed to continuously pronounce the vowel "i" in a natural, comfortable tone and volume for approximately 3-5 seconds. During this process:

[0058] The mechanical event occurs: Driven by the internal laryngeal muscles, the patient's left and right vocal cords close from an abducted position towards the midline. The free edge of the vocal cord that first contacts the wedge-shaped double-bevel sensor head 4 (assuming it's the right vocal cord) touches the right sensing bevel 7. As the vocal cord continues its inward and backward movement, it slides along and compresses the bevel 7. Subsequently, the left vocal cord contacts the left sensing bevel 6 and a similar process occurs. The force exerted by the vocal cords on the bevels can be decomposed into a normal pressure perpendicular to the bevel and a tangential frictional force parallel to the bevel.

[0059] Signal Acquisition and Preprocessing: The force sensing unit 9 senses the changes in the X-axis and Y-axis components of the resultant force acting on the probe in real time and converts these weak piezoresistive or capacitive changes into analog voltage signals. The motion sensing unit 10 continuously outputs the probe's own acceleration and angular velocity raw data. These raw signals are transmitted to the handheld signal processing handle 2 through the miniature shielded cable 18 and the connection interface 11.

[0060] Signal processing and wireless transmission: Inside the handle, the analog front end 14 amplifies the analog voltage of the force signal and converts it into a digital signal. The microcontroller 13 synchronously reads these digital force signals and inertial data from the motion sensing unit 10, packages them, and sends them in real time to the data analysis and display host 3 via the wireless transmission module.

[0061] Step 3: Core data processing and mechanical trajectory reconstruction (completed in the data analysis and display host 3)

[0062] This is a crucial step in transforming raw data into clinically interpretable information, where specialized software executes a series of complex algorithms:

[0063] Data reception and synchronization alignment: The software receives wireless data streams and video streams, and uses previously recorded timestamps to precisely align force signals, inertial data, and video frames on the timeline.

[0064] Motion compensation and coordinate transformation:

[0065] Objective: To eliminate interference with force signals caused by unintended probe movements due to operator hand tremors, patient swallowing, or pulse.

[0066] Algorithm: A sensor fusion algorithm based on Kalman filtering is adopted. This algorithm uses accelerometer data output by motion sensing unit 10. and gyroscope data As input.

[0067] Process: First, the gyroscope data is integrated to preliminarily estimate the probe's attitude angles (pitch, roll, yaw). Then, the accelerometer data is transformed to the global coordinate system, and the gravitational acceleration component is subtracted to obtain the linear acceleration of the probe's motion. The attitude angle and linear acceleration estimates are optimally fused using a Kalman filter to finally output a high-precision three-dimensional displacement of the probe. and three-dimensional angle Continuous time series.

[0068] Force signal purification: using the calculated probe acceleration According to Newton's second law (Where m is the equivalent mass of the probe tip, obtained through calibration) The inertial force is calculated. From the originally measured resultant force... , Subtract the inertial force component from the middle. Then, based on the real-time attitude angle... By rotating the force vector to a "reference coordinate system" fixed relative to the glottic anatomical plane, a purified force signal that primarily reflects the contact action of the vocal cords is obtained. .

[0069] Vocal cord contact event detection:

[0070] Principle: When the vocal cords come into contact with the inclined plane and begin to slide, a step or steep rising edge will be generated on the tangential force (mainly in the Y direction) signal.

[0071] Algorithm: For The signal is detected using a sliding window and threshold method. An adaptive threshold is set (e.g., 3-5 times the standard deviation of the baseline noise). When the signal crosses the threshold in a positive direction, record that moment as... This was determined to be the beginning of contact with the right vocal cord. When the signal crosses the threshold in the negative direction, it is recorded as It was determined that the left vocal cord contact had begun.

[0072] Output: Calculate the contact initiation time difference. The absolute value of Δt directly quantifies the synchronicity anomaly in the initiation of vocal cord movement.

[0073] Inverse calculation of inclined plane mechanics:

[0074] Model Establishment: This is the core physical model of this invention. For example... Figure 5 As shown in the mechanical analysis diagram, the total measuring force acting on the wedge-shaped double-inclined sensor head 4 is... The decomposition is onto the left induction inclined plane 6 and the right induction inclined plane 7.

[0075] Key equation: For each inclined plane, the force exerted by the vocal cords can be decomposed into a normal force N (perpendicular to the inclined plane) and a tangential frictional force f (parallel to the inclined plane). The relationship between the frictional force and the normal force satisfies... , where μ is the equivalent friction coefficient between the tissue and the inclined plane, which can be pre-calibrated within a range through experiments or dynamically estimated from signal characteristics.

[0076] Solution: Given the resultant force The inclined plane angle α / 2 (half of the apex angle α) and the friction coefficient μ can be used to establish a system containing... (Normal force on the left inclined plane) (Normal force on the right inclined plane) A system of equations with four unknowns. By solving this system of equations, we can obtain... Continuous time series. and This directly reflects the "squeezing" force exerted by the left and right vocal cords on the probe during the closure process, specifically:

[0077] Let the normal force exerted by the left vocal cord on the left induction inclined plane 6 be... The tangential friction force is The normal force exerted by the right vocal cord on the right induction inclined plane 7 is: The tangential friction force is According to the Coulomb friction model, the tangential friction force and the normal force satisfy:

[0078] (1)

[0079] Will , Projecting onto the X-axis (left-right direction) and Y-axis (front-back direction) of the reference coordinate system, we obtain the force components contributed by the left inclined plane; similarly, we project onto the right inclined plane. Total measured force. , The sum of the vector contributions from the left and right inclined planes should be used to establish a system of equations:

[0080] (2)

[0081] Substituting equation (1) into equation (2), we can eliminate... and , get about and A system of two linear equations in two variables:

[0082] (3)

[0083] Solve for normal and tangential forces

[0084] Solving the system of equations (3), we can obtain the analytical expression for the normal force of the left and right vocal cords:

[0085] (4)

[0086] (5)

[0087] Then obtain and Substituting into equation (1), the tangential force can be obtained. and Continuous time series.

[0088] Derivative parameter calculation and trajectory plot generation:

[0089] Dynamic stiffness: calculation and .in K(t) represents the micro-displacement change of the probe in the X direction (obtained from the motion compensation mechanism). K(t) reflects the change in the "hardness" of the vocal cord edge tissue during dynamic compression and is closely related to the active contraction tension of the thyroarytenoid muscle and other intralarial muscles.

[0090] Closure power: Estimate the instantaneous velocity v(t) of the vocal cords sliding along the inclined plane. This can be obtained by differentiating the displacement dy(t) of the probe in the Y direction, or based on the frictional force f(t) and the friction model. An estimation is performed. Then, the instantaneous mechanical power is calculated. and This reflects the change in power generated by the closure of the vocal cords.

[0091] Plotting: The software plots multiple curves within a single, comprehensive view, with time as the horizontal axis, including... ,

[0092] This forms a dynamic mechanical trajectory diagram of vocal cord closure. Simultaneously, it marks the time axis. and .

[0093] Step 4: Visualizing, Interpreting, and Reporting Results

[0094] Synchronous Display: The software interface of the data analysis and display host 3 is typically divided into multiple views. The main view displays the real-time (or playback) video of the electronic laryngoscope 16 and the generated mechanical trajectory diagram side by side. The software can achieve "linked playback," where the video automatically jumps to the corresponding time point when the cursor moves on the trajectory diagram, realizing an intuitive correlation between mechanical events and morphological changes.

[0095] Parameter Analysis: The software automatically analyzes the trajectory diagram and calculates the statistical values ​​of key parameters, such as peak force, average force, time to peak, mean stiffness, power integral, and most importantly, the symmetry index (e.g., based on peak force). These quantitative indicators are presented in tabular form.

[0096] Report generation: Operators can save or print a complete evaluation report containing keyframe screenshots of videos, mechanical trajectory diagrams, and data tables for use in medical record archiving, academic exchanges, or before-and-after treatment comparisons.

[0097] After the measurement is completed, the operator removes the disposable probe assembly 1 from the handle and disposes of it as medical waste. The connection interface 11 of the handheld signal processing handle 2 is wiped and disinfected with medical disinfectant wipes for future use.

[0098] This embodiment, through the aforementioned specific structure and workflow, achieves a revolutionary assessment method for laryngeal muscle function, particularly the mechanical characteristics of the dynamic closure process of the vocal cords. Its technical advantages are primarily reflected in the following: For the first time, a sophisticated passive wedge-shaped double-inclined sensor head stably transforms the bilateral coordinated movement of the vocal cords, which cannot be directly observed clinically, into a multidimensional mechanical signal that can be precisely quantified. This fundamentally fills the gap in dynamic process mechanical assessment using existing laryngoscopy, electromyography, and airflow dynamics techniques. The system's operation is standardized, requiring only the probe to be placed at the anterior glottal commissure fixation point, greatly reducing reliance on operator experience and ensuring the repeatability and comparability of measurement results. The core algorithm performs high-precision motion compensation by fusing inertial sensor data, effectively eliminating operational interference, and performs inverse mechanical calculations based on a clear inclined plane physical model, ultimately generating a dynamic mechanical trajectory diagram containing multiple dimensions such as timing, force, stiffness, and power. The synchronized display of this trajectory map and laryngoscopic images achieves a deep integration of morphology and function, providing unprecedented, intuitive, and quantitative decision-making basis for the accurate diagnosis of diseases such as vocal cord paralysis and dystonia, the quantitative design of personalized surgical plans (such as determining the vocal cord injection volume or the corrective force of thyroid cartilage repair surgery), and the objective evaluation of rehabilitation efficacy. This significantly improves the objectivity, accuracy, and clinical practical value of laryngeal functional assessment. The core mechanical structure of the entire system is simple and reliable, and the main electronic components are based on mature commercial chips, possessing good feasibility and industrialization prospects.

[0099] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. A system for evaluating the mechanical trajectory of the vocal cords during dynamic closure, characterized in that, The device includes a disposable probe assembly, a handheld signal processing handle, and a data analysis and display host. A wedge-shaped double-bevel sensing head is fixedly mounted at the distal end of the disposable probe assembly, and a waterproof electrical interface is fixedly mounted at the proximal end. A connection interface is fixedly mounted at the front end of the handheld signal processing handle, and the waterproof electrical interface of the disposable probe assembly is detachably connected to the connection interface of the handheld signal processing handle. The handheld signal processing handle is communicatively connected to the data analysis and display host. The wedge-shaped double-bevel sensing head includes a left sensing bevel and a right sensing bevel, which intersect to form a apex angle. A multi-dimensional sensing module is fixedly mounted inside the disposable probe assembly, and the multi-dimensional sensing module is electrically connected to the waterproof electrical interface. A signal processing circuit is fixedly mounted inside the handheld signal processing handle, and the signal processing circuit is electrically connected to the connection interface.

2. The vocal cord dynamic closure process mechanical trajectory evaluation system according to claim 1, characterized in that: The multidimensional sensing module includes a force sensing unit and a motion sensing unit; the force sensing unit is a two-dimensional force sensor; and the motion sensing unit is an inertial measurement unit.

3. The vocal cord dynamic closure process mechanical trajectory evaluation system according to claim 2, characterized in that: The signal processing circuit includes a microcontroller, an analog front-end, and a wireless transmission module; the input terminal of the analog front-end is connected to the waterproof electrical interface through the connection interface; the output terminal of the analog front-end is connected to the microcontroller; the wireless transmission module is connected to the microcontroller; and the wireless transmission module is communicatively connected to the data analysis and display host.

4. The vocal cord dynamic closure process mechanical trajectory evaluation system according to claim 3, characterized in that: It also includes an imaging device; the data analysis and display host is communicatively connected to the imaging device and is used to receive throat images acquired by the imaging device.

5. The vocal cord dynamic closure process mechanical trajectory evaluation system according to claim 4, characterized in that: The imaging device is a stand-alone laryngoscope.

6. The vocal cord dynamic closure process mechanical trajectory evaluation system according to claim 5, characterized in that: The data analysis and display host includes a motion compensation module, a time sequence recognition module, a mechanics calculation module, and a trajectory generation module; The motion compensation module is used to calculate the motion of the disposable probe assembly based on the data from the motion sensing unit, and to compensate for the mechanical signals detected by the force sensing unit. The timing recognition module is used to identify the first starting time of contact between the left vocal cord and the left sensing inclined plane, and the second starting time of contact between the right vocal cord and the right sensing inclined plane, based on the compensated mechanical signal. The mechanical calculation module is used to calculate the left normal force and left tangential force acting on the left sensing inclined plane, and the right normal force and right tangential force acting on the right sensing inclined plane, based on the compensated force signal according to the inclined plane mechanical model. The trajectory generation module generates and displays a dynamic closure mechanical trajectory diagram of the vocal cords, including the curves of the left normal force, the right normal force, the left tangential force, and the right tangential force changing over time.

7. The vocal cord dynamic closure process mechanical trajectory evaluation system according to claim 6, characterized in that: The data analysis and display host is also used to synchronously overlay and display the dynamic closure mechanical trajectory diagram of the vocal cords with the laryngeal image.

8. The vocal cord dynamic closure process mechanical trajectory evaluation system according to claim 1, characterized in that: The surfaces of the left and right sensing slopes are provided with micro-textured structures.

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