Airway patency evaluation device and method

Abstract

The invention discloses an airway patency assessment device. The airway patency assessment device comprises a catheter body, a measuring assembly and an assessment assembly, the catheter body is trumpet-shaped, the two ends of the catheter body are open, the opening of the large-diameter end is an expiration port, the opening of the small-diameter end is an air outlet, an air flow channel is formed between the expiration port and the air outlet, and air enters the air flow channel through the expiration port formed in the catheter body; a reed set is arranged on the inner wall of the guide pipe body and comprises at least one reed, and the reed can generate vibration when making contact with airflow. The measuring assembly is used for collecting vibration data of the reed group; and the evaluation assembly is used for evaluating the airway patency based on the vibration data acquired by the measurement assembly. And the smoothness of the air passage can be evaluated through vibration generated when the arranged reed is in contact with the air flow.

Description

Technical Field

[0001] This invention belongs to the field of medical technology, and specifically relates to an airway patency assessment device and method. Background Technology

[0002] The respiratory tract is the essential pathway for gas exchange, and its patency is crucial for the body to obtain oxygen and expel carbon dioxide. Airway obstruction, where airflow is partially or completely blocked, is a widespread and potentially life-threatening clinical problem. The causes of airway obstruction are complex and varied. Physical obstruction factors mainly include accidental aspiration of foreign bodies, excessive secretion retention after damage to the respiratory mucosa, airway mucosal inflammation and edema (such as allergic reactions or infections), proliferative tissue within the airway lumen (such as polyps), invasion and growth of malignant tumors into the airway, or compression from external space-occupying lesions (such as goiter or abnormally dilated blood vessels). Simultaneously, neuromuscular dysfunction (such as vocal cord paralysis due to recurrent laryngeal nerve damage) weakens the respiratory muscles' ability to support and protect the airway, and abnormally increased muscle tone can also significantly constrict the airway space (such as bronchospasm in asthma).

[0003] Loss of airway patency directly weakens the body's ability to exchange gases efficiently with the external environment, and the severity of the harm is directly related to the severity and duration of the obstruction. Mild obstruction can cause shortness of breath and discomfort after activity and a decrease in gas exchange efficiency; moderate to severe obstruction can rapidly lead to tissue hypoxia and carbon dioxide retention, causing typical symptoms such as a feeling of suffocation, irritability, and cyanosis of the lips; if not corrected in a timely and effective manner, severe obstruction can rapidly develop into fatal asphyxia, causing irreversible ischemic and hypoxic damage to core organs such as the heart and brain in a short period of time, ultimately inducing multiple organ failure and even death.

[0004] Currently in clinical practice, airflow sensing is a basic and rapid non-invasive examination method for assessing airway patency.

[0005] During the procedure, medical staff gently place the back of their hand about 3-5 centimeters in front of the patient's mouth and nose. By sensing the flow rate, temperature changes, and continuity of the exhaled airflow, they can make a preliminary assessment of whether there is an airway obstruction. During normal breathing, a continuous, even, warm airflow can be felt on the back of the hand; if the airflow is weak, intermittent, or cannot be felt, it suggests that there may be partial or complete obstruction of the upper airway.

[0006] While this method of assessment is simple, it relies heavily on the doctor's clinical experience and subjective feeling, lacking objective and quantifiable standards. Different doctors may arrive at different results, especially when it comes to judging borderline conditions, where consensus is difficult to reach. Furthermore, it cannot provide specific grading, only a rough distinction between "presence / absence of airflow," making it difficult to quantify the severity of obstruction. Especially in mild obstruction, changes in exhaled airflow are subtle and may not be detectable by touch, leading to false negatives. This results in patients not receiving timely intervention, increasing the risk of complications.

[0007] During the procedure, it is necessary to observe the patient's breathing movements simultaneously. If the patient has chest rise and fall but low ventilation efficiency, such as severe bronchospasm or lung parenchymal disease, the back of the hand may feel airflow, but the actual gas exchange is insufficient, which can easily be misjudged as patency.

[0008] In addition, external airflow interference cannot be ruled out. For example, environmental airflow such as air conditioning or indoor ventilation can easily confuse the patient's exhaled airflow, reducing the accuracy of the test.

[0009] In summary, how to provide an airway patency assessment device and method based on airflow perception is a technical problem that urgently needs to be solved. Summary of the Invention

[0010] The purpose of this invention is to overcome the shortcomings of the prior art and provide an airway patency assessment device and method that can assess airway patency by means of the vibration generated when a reed contacts the airflow.

[0011] The technical solution of the present invention is: an airway patency assessment device, comprising a catheter body, a measuring component, and an assessment component;

[0012] The catheter body is funnel-shaped with openings at both ends. The larger diameter end is the exhalation port, and the smaller diameter end is the exhaust port. An airflow channel is formed between the exhalation port and the exhaust port. Gas enters the airflow channel through the exhalation port on the catheter body. The edge of the funnel-shaped opening can contact and conform to the patient's facial skin. A sealing ring can be set around the inner side of the funnel-shaped opening near the edge, so that it can have a certain degree of sealing when conforming to the patient's facial skin, preventing gas from escaping to the outside.

[0013] A reed assembly is provided on the inner wall of the duct body, the reed assembly including at least one reed, the reed being able to vibrate when in contact with airflow;

[0014] The measuring component is used to collect vibration data of the reed assembly;

[0015] The evaluation component is used to assess airway patency based on vibration data collected by the measurement component.

[0016] Furthermore, the reed assembly adopts any of the following structural configurations:

[0017] Method 1: The reed assembly includes multiple polypropylene film reeds, each with a thickness of 0.05 mm to 1 mm, symmetrically arranged on the inner wall of the conduit body; when airflow passes through, the polypropylene film reeds can undergo bending vibration;

[0018] Method 2: The reed assembly includes multiple reeds, each made of medical-grade silicone material with a thickness of 0.2 mm, arranged in a fan shape; the root of each reed is fixed to the inner wall of the catheter body, and the free end is inclined towards the airflow direction, which can generate multi-frequency vibration under the action of expiratory airflow;

[0019] Method 3: The reed assembly includes multiple polyethylene sheet reeds, each with a thickness in the range of 0.08-0.15mm, arranged in a spiral shape on the inner wall of the duct body. This arrangement can generate vortices in the airflow and enhance the vibration response sensitivity of the reeds.

[0020] Method 4: The reed assembly includes multiple polyurethane film reeds with a thickness of 0.1 mm and micro-protrusion structures on the surface; each reed is distributed asymmetrically on both sides of the channel, which can generate differential vibration when airflow passes through, making it convenient to evaluate airflow characteristics in multiple dimensions.

[0021] Method 5: The reed assembly comprises multiple reeds made of biocompatible PET film, each reed being 0.05-0.3 mm thick and arranged in a grid pattern;

[0022] Method 6: The reed assembly includes multiple reeds, each reed being made of multi-layer composite material, with each single layer of the reed having a thickness of 0.01-0.02 mm and a total thickness not exceeding 0.3 mm;

[0023] Method 7: The reed assembly includes multiple reeds, each employing a master-slave reed structure. The master reed connects to multiple tendril-like secondary reeds. When the master reed is pushed by a weak airflow, the secondary reeds generate secondary amplified vibrations. This method is suitable for analyzing shallow and rapid breathing patterns in infants, the elderly, and other individuals. It effectively enhances the detection sensitivity to low-velocity airflows, avoids false negative results, and maintains a simple and reliable structure without requiring additional energy consumption, thus improving its practicality in resource-limited environments.

[0024] Method 8: The reed group comprises several reeds arranged at intervals along the airflow direction, and the length of the reeds decreases gradually along the airflow direction.

[0025] Method 9: The reed group includes multiple reeds, each reed having a forked front end, including several adjacent forks, which are either close together or spaced apart.

[0026] Furthermore, the connection between the reed and the inner wall of the catheter body can be at least one of the following:

[0027] The first method involves a connecting part made of a hot-melt material at the bottom of the spring, which positions the spring at preset grid points on the inner wall, and then the connecting part is placed under heating conditions to achieve hot-melt fixation.

[0028] The second type has a groove on the inner wall of the airflow channel, and a corresponding locking tooth on the root of the reed is provided to match the groove; the locking tooth is embedded in the groove to achieve a fixed connection between the root of the reed and the inner wall of the airflow channel.

[0029] The groove and the tooth can be connected in two ways: 1. The groove and the tooth are perfectly matched, and the tooth is embedded in the groove without any additional movement space; 2. The groove has a certain longitudinal length, which is equivalent to a slide rail. After the tooth is embedded in the groove, it can move within the length of the groove.

[0030] When airflow passes through the airflow channel, the airflow will exert a pushing force on the reed, which may guide the reed to produce a slight displacement in the direction of airflow. A corresponding displacement sensor is set up to collect the displacement data of the reed and send it to the evaluation module as one of the reference factors for subsequent airway patency assessment.

[0031] The third type involves connecting the spring to the inner wall of the conduit body via a fixing component.

[0032] Furthermore, in the third connection method, the fastener can be either a base or an elastic clamping structure;

[0033] When the fixing component is a base, the base is fixedly connected to the inner wall of the conduit body. The top or side of the base is provided with a slot that matches the bottom of the spring. The connection is achieved by inserting the bottom of the spring into the slot. After the bottom of the spring is inserted into the slot, the locking mechanism is hinged to both sides of the slot. The locking component rotates inward and presses the two sides of the spring, further strengthening the fixation of the spring in the slot. While the bottom of the spring remains fixed in the slot, the other parts of the spring are exposed outside the slot, so that they can come into contact with the airflow and vibrate when the airflow passes through the airflow channel.

[0034] When the fixing component is an elastic clamping structure, the inner surface of the fixing component is provided with anti-slip texture to prevent the spring from sliding during the clamping process. After the spring is pushed in laterally from the opening of the clamping component, the clamping arm tightens and clamps the spring by relying on the rebound force, thereby fixing the spring to the inner wall of the conduit body.

[0035] Furthermore, the measuring component includes a vibration amplification structure connected to a reed drive; the vibration amplification structure includes at least an L-shaped rocker arm, one end of which is hinged to a reed, and the other end is connected to a gear set; the gear set includes a sector gear connected to the L-shaped rocker arm, and a planetary gear system meshing with the sector gear, for reducing the rotational speed of the sector gear and increasing the torque.

[0036] Furthermore, the pointer is fixed to the end of the output shaft of the gear set, and the rotation angle of the pointer is positively correlated with the spring amplitude;

[0037] An angle sensor is used to measure the rotation angle of the pointer;

[0038] The evaluation component is used to assess airway patency based on the rotation angle of the pointer.

[0039] Furthermore, the measuring component includes a piezoelectric ceramic sheet disposed at the root of the reed, which can generate an electric charge signal when the reed vibrates;

[0040] The evaluation component is used to assess airway patency based on charge signals.

[0041] Furthermore, it also includes an inflation assembly located at the air outlet, the inflation assembly comprising a soft balloon connected to the air outlet via a one-way valve; the one-way valve only allows gas to enter the soft balloon through the airflow channel;

[0042] It also includes a balloon detection component, which is used to detect changes in the inflation of a balloon;

[0043] The evaluation component is used to assess airway patency based on changes in balloon inflation.

[0044] Furthermore, the balloon detection assembly also includes a rigid frame capable of accommodating the balloon; the outer surface of the balloon is able to contact the inner side of the rigid frame during inflation.

[0045] A pressure sensor is installed on the inner side of the rigid frame facing the balloon to collect the pressure exerted by the outer surface of the balloon on the inner side of the rigid frame.

[0046] The present invention also provides a method for assessing airway patency, wherein airway patency is assessed using any of the airway patency assessment devices described herein.

[0047] By adopting the above technical solution, this invention, as an example, has the following advantages and positive effects compared with the prior art:

[0048] The funnel-shaped structure of the catheter body enlarges the opening at the tip, facilitating inward exhalation by the patient and smoothly guiding airflow into laminar or stable flow, reducing turbulence and energy loss, and improving data accuracy and ease of use. A reed assembly within the airflow channel vibrates under the influence of airflow. The reeds, made of soft material, generate high-frequency, low-amplitude or low-frequency, high-amplitude vibrations depending on whether the airflow is smooth or turbulent, thus providing a means of distinguishing between airway patency and obstruction. The combination of various reed structural designs enhances the responsiveness to weak airflow, making it suitable for populations with weak airflow, such as the elderly, children, and patients with lung diseases, thus improving clinical adaptability.

[0049] The optional gradient-decreasing reed length arrangement avoids resonance coupling problems, covers the range of airflow velocity variations, reduces measurement blind spots, and ensures data stability and noise suppression.

[0050] The optional sound acquisition component, combined with a reed design, can analyze acoustic characteristics such as sound pressure level and spectrum. The balloon, in conjunction with the balloon detection component, can detect changes in balloon expansion and correlate them with the degree of airway obstruction, providing supplementary assessment data, offering more assessment dimensions, achieving multi-parameter comprehensive judgment, and improving the overall assessment accuracy and robustness. Attached Figure Description

[0051] Figure 1 This is a schematic diagram of the airway patency assessment device provided by the present invention.

[0052] Figure 2 This is a schematic diagram of the structure of the reed provided by the present invention, which is another embodiment.

[0053] Figure 3 This is a schematic diagram of the structure of the reed provided by the present invention, which is another embodiment.

[0054] Figure 4 This is a schematic diagram of the structure of the reed provided by the present invention, which is another embodiment.

[0055] Figure 5 This is a schematic diagram of the airway patency assessment device provided by the present invention, which is another embodiment.

[0056] Figure 6 This is a schematic diagram of the airway patency assessment device provided by the present invention, which is another embodiment.

[0057] Figure 7 This is a schematic diagram of the airway patency assessment device provided by the present invention, which is another embodiment.

[0058] Figure 8 This is a schematic diagram of the structure of the reed provided by the present invention, which is another embodiment.

[0059] Airway patency assessment device 100;

[0060] The catheter body 200, the inner wall of the catheter body 201, the exhalation port 210, the outlet port 220, the reed assembly 230, the reed 231, the main reed 231-1, the auxiliary reed 231-2, the single layer reed 231-3, the bifurcation 232, and the groove 240.

[0061] Inflation assembly 300, one-way valve 310, balloon 320, rigid frame 330, pressure sensor 340. Detailed Implementation

[0062] The technical solutions disclosed in this invention will be described in detail below with reference to specific embodiments.

[0063] Techniques and methods known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques and methods should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values.

[0064] This invention provides an airway patency assessment device 100, such as... Figure 1 As shown, it includes: a duct body 200 with an airflow channel.

[0065] Gas enters the airflow channel through the exhalation port 210 provided on the catheter body 200. The airflow channel is open at least one end, and the opening is connected to the exhalation port 210 provided on the catheter body 200.

[0066] A reed assembly 230 is provided on the inner wall of the airflow channel, and the reed assembly 230 includes at least one reed 231.

[0067] As a typical implementation, the reed 231 is made of a soft material and is thin, so that it can vibrate when in contact with airflow.

[0068] Specifically, when the airway is clear, the patient's exhaled airflow is relatively stable with a high average velocity, primarily exhibiting laminar or low-turbulence. This stable airflow exerts a relatively uniform force on the reed 231, potentially resulting in high-frequency, low-amplitude, and regularly shaped vibrations. Conversely, when the patient's airway is obstructed, such as by bronchospasm, secretions, or airway narrowing, the airflow becomes turbulent with a lower average velocity, forming strong turbulence. Turbulence is characterized by uneven velocity and pressure distribution, dispersed energy, and often contains low-frequency vortex components. This turbulent airflow exerts irregular and impactful forces on the reed 231, causing it to produce low-frequency, high-amplitude, and chaotic vibrations, potentially containing multiple low-frequency harmonic components.

[0069] In one implementation, for example, such as Figure 1 As shown, the reed assembly 230 consists of two groups of 12 polypropylene film reeds 231, with a thickness of 0.05 mm to 1 mm, symmetrically arranged on the inner wall of the airflow channel. When airflow passes through, the reeds 231 can undergo bending vibration, and their vibration is affected by the airflow conditions.

[0070] Alternatively, the reeds 231 are made of medical-grade silicone material with a thickness of approximately 0.2 mm, and are arranged in a fan-shaped distribution. The base of each reed 231 is fixed to the inner wall of the channel, and the free end is arranged at an angle towards the airflow direction, which can generate multi-frequency vibration under the action of the exhaled airflow.

[0071] Alternatively, the reed assembly 230 may comprise several polyethylene sheets, with a thickness ranging from 0.08 to 0.15 mm, arranged in a spiral pattern on the inner wall of the channel. This arrangement can create vortices in the airflow, enhancing the vibration response sensitivity of the reed 231.

[0072] Alternatively, the reed 231, made of polyurethane material, is approximately 0.1 mm thick and has micro-protrusions on its surface. The reed 231 is asymmetrically distributed on both sides of the channel, generating differential vibrations as airflow passes through, facilitating multi-dimensional evaluation of airflow characteristics.

[0073] Alternatively, reeds 231 can be made from biocompatible PET film with a thickness of 0.05-0.3 mm and arranged in a grid pattern.

[0074] In another implementation, such as Figure 3 As shown, the reed 231 can be made of multi-layer composite material, with each single layer of reed 231-3 having a thickness of approximately 0.01-0.02 mm and a total thickness not exceeding 0.3 mm.

[0075] The thicknesses listed above are examples and not strict limits on actual thicknesses. The thickness range may be adjusted depending on the flexibility and hardness of the chosen material.

[0076] For example, for the elderly, children, and special groups with underlying lung diseases, who exhale less air and have weaker airflow, the reed assembly 230 can use a thinner and less rigid reed 231, which can generate effective vibration even under low-speed airflow.

[0077] This approach optimizes the flexibility and durability of materials through layered stacking, maintaining a stable vibration response under actual airflow impact, reducing the risk of fatigue fracture, and expanding the frequency response range to accommodate the complex waveforms of turbulence. The multi-layered structure improves amplitude consistency under high-speed airflow and has a longer lifespan than a single-layered reed, making it suitable for long-term monitoring scenarios such as chronic respiratory disease management, ensuring more durable and reliable assessment results. However, the cost is slightly higher, and a balance needs to be struck between clinical economics and cost.

[0078] The shape of the reed 231 can be, but is not limited to, strip, fan, sheet, circle, triangle, curved surface, etc. Different shapes and thicknesses of the reed 231 will have different movement patterns in response to airflow, which can be set according to different clinical needs.

[0079] In practical applications, the reeds 231 included in the reed assembly 230 do not need to adopt a uniform specification, and can include reeds 231 of different shapes, materials and sizes.

[0080] For example, such as Figure 2 As shown, a "master-slave reed 231" structure is adopted: a 0.08mm fan-shaped master reed 231-1 connects to a 0.04mm whisker-shaped auxiliary reed 231-2. When the master reed 231-1 is pushed by a weak airflow, the auxiliary reed 231-2 generates a secondary amplified vibration, which is suitable for analyzing shallow and rapid breathing patterns in infants, the elderly, and other individuals. It can effectively enhance the detection sensitivity to low-velocity airflow, avoid false negative results, and maintain a simple and reliable structure without additional energy consumption, thus improving its practicality in resource-constrained environments.

[0081] In the specific production process, the connection between the reed 231 and the inner wall of the airflow channel can be at least one of the following methods:

[0082] Firstly, the bottom of the spring 231 is provided with a connecting part made of a hot-melt material. The spring 231 is positioned on the preset grid points on the inner wall of the channel, and then the connecting part is placed under heating conditions to achieve hot-melt fixation.

[0083] Secondly, such as Figure 4 As shown, a groove 240 is provided on the inner wall of the airflow channel, and a corresponding retaining tooth is provided on the root of the spring 231 to match the groove. The retaining tooth is embedded in the groove to achieve a fixed connection between the root of the spring 231 and the inner wall of the airflow channel.

[0084] The groove can be perfectly matched with the locking teeth, with no additional movement space required when the teeth are embedded in the groove. Alternatively, the groove can have a certain longitudinal length, acting as a slide rail, allowing the locking teeth to move within the groove's length after being embedded.

[0085] When airflow passes through the airflow channel, it exerts a pushing force on the reed 231, which may cause a slight displacement of the reed 231 in the direction of airflow. A corresponding displacement sensor is set up to collect the displacement data of the reed 231 and send it to the evaluation module as one of the reference factors for subsequent airway patency assessment.

[0086] This design, through a movable toothed-slide rail structure, converts the horizontal thrust of airflow on the reed into a measurable displacement signal, providing another crucial dimension of data for assessment besides vibration frequency and amplitude. Its advantages are as follows: First, the slide rail fixing method, while ensuring root connection strength, allows for axial displacement of the reed. This displacement directly reflects the static pressure or thrust level of the airflow, effectively supplementing the shortcomings of vibration signals (mainly reflecting flow velocity and eddies) in assessing steady-state or low-speed airflow, making the assessment of airway resistance more comprehensive. Second, this structure provides overload protection; when encountering a sudden strong airflow impact, the reed can buffer stress through slight backward movement, thereby reducing the risk of root breakage and improving the probe's durability and reliability. Finally, combined with data acquired by the displacement sensor, the assessment module can more accurately infer the airflow state. For example, in the assessment of positive end-expiratory pressure (PEEP) effects commonly seen in asthma or COPD patients, this displacement parameter provides direct evidence and reduces misjudgment; however, regular calibration of the displacement sensor is necessary to ensure data accuracy.

[0087] In another embodiment, the reed 231 is connected to the inner wall of the airflow channel by a fastener. The fastener is integrally formed with the inner wall of the airflow channel, or is connected to the inner wall of the airflow channel by bolts, welding or other fixing methods.

[0088] By way of example and not limitation, the fastener can be a base, which is fixedly connected to the inner wall of the airflow channel. The base has a slot on its top or side that matches the bottom of the spring 231. Connection is achieved by inserting the bottom of the spring 231 into the slot. After the bottom of the spring 231 is inserted into the slot, a locking structure hinged to both sides of the slot rotates inward and presses against the two sides of the spring 231, further strengthening the fixation of the spring 231 in the slot. While the bottom of the spring 231 remains fixed in the slot, the other parts of the spring 231 are exposed outside the slot, allowing them to contact the airflow and vibrate as the airflow passes through the airflow channel.

[0089] In another embodiment, the fixing member is an elastic clamping structure with anti-slip texture on the inner surface to prevent the spring 231 from sliding during clamping. After the spring 231 is pushed laterally into the clamping member through the opening, the clamping arm tightens and clamps the spring 231 by relying on the rebound force, thereby fixing the spring 231 to the inner wall of the airflow channel.

[0090] The catheter body 200 has a funnel-shaped structure, with the inner diameter of the front end, where the exhalation port 210 is located, being larger than that of the rear end 220. When using it, the patient simply brings their mouth close to the funnel-shaped opening and exhales into it. The large-diameter front end provides a larger target area, easily capturing even if the patient's mouth is not perfectly centered or the airflow is slightly off-center, reducing the requirement for precise positioning. Furthermore, the large-diameter front end allows exhaled air to easily enter the catheter at a lower speed and pressure. After the air enters, the gradually narrowing channel smoothly accelerates and compresses the air, stably guiding it towards the smaller inner diameter of the rear end 220. This avoids strong eddies and turbulence caused by sudden contraction of the air upon entry, preventing additional energy loss and noise, and helps to create a smoother laminar or stable flow, aiding the sensor at the rear end 220 in acquiring accurate data.

[0091] Furthermore, the flared opening edge can contact and fit against the patient's facial skin. A sealing ring can be placed around the inner side of the flared opening near the edge, so that it can have a certain degree of sealing when it fits against the patient's facial skin, preventing gas from escaping to the outside.

[0092] The measuring component is used to collect vibration data of the reed assembly 230. In actual measurement, in order to further improve the accuracy of vibration data acquisition, a vibration amplification structure is also included, which is connected to the reed 231 to amplify the vibration of the reed 231.

[0093] The vibration amplification structure includes at least an L-shaped rocker arm, one end of which is hinged to a spring 231. This spring 231 can be connected to the end near the root of the spring 231, or to other positions including the lower half, middle half, or upper half of the spring 231. The other end of the L-shaped rocker arm is connected to a gear set.

[0094] The L-shaped rocker arm consists of a short arm and a long arm. The short arm is connected to a spring 231, and the long arm is connected to a transmission component. When airflow causes a slight vibration at the end of the spring 231, the short arm of the L-shaped rocker arm, hinged to the spring 231, swings accordingly. Because the long arm of the rocker arm is much longer than the short arm, under the condition of a fixed fulcrum, the end of the long arm will produce a large displacement due to the much larger lever arm of the long arm than that of the short arm. This mechanism can effectively amplify the small displacement at the end of the spring 231.

[0095] Furthermore, the gear set includes at least one sector gear connected to the L-shaped rocker arm.

[0096] A sector gear can include a set of small-diameter gears and a set of large-diameter gears. A transmission component connected to the end of the long arm of the rocker arm drives the gear set: first, it drives the small-diameter gear to rotate rapidly, and then through meshing transmission, it converts the high-speed, low-torque rotation of the small gear into the low-speed, high-torque rotation of the large gear. This process amplifies the amplitude of the motion.

[0097] Finally, the large gear shaft connects to the eccentric cam, converting the rotational motion into linear reciprocating motion, completing the third amplification.

[0098] Furthermore, it also includes a planetary gear system meshing with the sector gear to reduce the sector gear's rotational speed and increase torque. The output shaft of the sector gear directly drives the sun gear to rotate, at which point the three planetary gears fixed on the planet carrier simultaneously generate two combined motions:

[0099] On one hand, it revolves around the sun gear; on the other hand, it rotates under the meshing constraint of the sun gear and the ring gear. First, the high-speed rotation of the sun gear is divided into multiple paths for transmission by the planetary gears, and the kinetic energy is distributed to the tooth surfaces of each planet gear. Second, the fixed gear ring of the ring gear forces the planet gears to continuously change their rotation direction during rolling, and each meshing transmission is accompanied by angular momentum recombination. Finally, the planet carrier connected to the output shaft integrates the rotational components of each planet gear, converting the high-speed, low-torque input into a low-speed, high-torque uniform rotation.

[0100] The vibration amplification structure essentially transforms the high-frequency, low-amplitude vibration of the reed 231 into low-frequency, high-amplitude mechanical motion. Through lever displacement gain, gear torque conversion, and motion transformation, the original vibration signal is amplified to a detectable amplitude while maintaining the vibration frequency characteristics, ensuring the accuracy of clinical testing. All hinge points in the transmission chain are designed as low-friction structures to maximize vibration energy transmission efficiency.

[0101] The pointer is fixed to the end of the output shaft of the gear set. The fixing method can be screws, clips, or welding to ensure a tight connection between the pointer and the output shaft, preventing loosening or slippage. When the reed 231 vibrates, it first causes the short arm of the L-shaped rocker arm to swing. The long arm amplifies the swing amplitude and transmits it to the output shaft of the gear set, causing the pointer to rotate. The rotation angle of the pointer is positively correlated with the amplitude of the reed 231.

[0102] Dominated by the average thrust of the airflow, following the formula:

[0103]

[0104] When the airway is clear, the patient's exhaled airflow is relatively stable. The stable airflow applies a relatively uniform force to the reed 231, causing the reed 231 to vibrate at a high frequency and low amplitude, resulting in a small deflection angle of the corresponding pointer.

[0105] Conversely, turbulent airflow will exert irregular and impactful forces on the reed 231, causing the reed 231 to vibrate at low frequency and high amplitude, resulting in a large deflection angle of the pointer.

[0106] Therefore, in summary, the smaller the deflection angle of the pointer, the clearer the patient's airway, and vice versa.

[0107] Optionally, the pointer is equipped with a dial to indicate the pointer's rotation angle. Furthermore, the rotation angle can correspond to different levels of airway patency. For example, an angle deflection of 0-W° or less indicates an open airway, W-X° indicates mild airway obstruction, X-Y° indicates moderate airway obstruction, and Y-Z° indicates severe airway obstruction. W, X, Y, and Z are any values ​​between 0 and 180°, and W < X < Y < Z.

[0108] An angle sensor is used to measure the rotation angle of a pointer; specifically, it can be measured through non-contact electromagnetic induction.

[0109] For example, a permanent magnet mounted coaxially on the pointer base rotates synchronously with the pointer, and three sets of induction coils arranged in a ring around it. When the north and south poles of the permanent magnet change with rotation, differentiated induced electromotive forces are generated in each coil, forming a voltage signal combination that precisely corresponds to the rotation position.

[0110] The evaluation component receives the voltage signal and calculates the deflection angle of the pointer to assess airway patency. The calculation process is similar to that of angle sensing in existing technologies and will not be elaborated upon here.

[0111] Alternatively, the pointer may be equipped with a scale, the graduations on which correspond to the degree of pointer deflection. The scale and pointer can be positioned on the side surface of the catheter body 200, or near the surface, with a transparent window providing an external observation route. Furthermore, the angular range of deflection can be differentiated by different colors. For example, the 0-W° range could be represented in green, the WX° range in yellow, the XY° range in orange, and the YZ° range in red. This allows patients or medical staff to intuitively understand the test results and intervene promptly in case of abnormalities.

[0112] Meanwhile, a communication component can be installed on the dial to send the dial reading to the evaluation component, which then evaluates the airway patency based on the received value.

[0113] In another embodiment, the measuring component includes a piezoelectric ceramic plate disposed at the root of the reed 231, which can generate an electric charge signal when the reed 231 vibrates.

[0114] Specifically, when a piezoelectric ceramic sheet is subjected to mechanical stress and deforms, the charges in its internal crystal structure separate, thereby generating a charge signal (Q) at its two poles that is proportional to the stress. This process follows the piezoelectric equation Q = d × F, where d is the piezoelectric constant of the material and F is the force transmitted to the root of the reed 231 when the reed 231 vibrates.

[0115] For a relatively stable and uniform airflow, the reed 231 will generate a weak high-frequency vibration under the airflow, generating a regular but small-amplitude charge signal on the piezoelectric sheet; while an unstable airflow will cause the reed 231 to generate a low-frequency vibration, generating a large-amplitude and complex-wavelength charge signal on the piezoelectric sheet.

[0116] The assessment component determines the condition of the patient's exhaled airflow based on different waveforms and amplitudes of the charge type, thereby assessing the corresponding airway patency.

[0117] The evaluation component is used to assess airway patency based on vibration data sent by the data acquisition component.

[0118] Vibration data typically includes at least one of the vibration frequency and vibration amplitude of the reed 231.

[0119] The vibration amplitude and vibration frequency of the reed 231 can be measured by measuring components, such as the vibration amplification structure described above, and the piezoelectric ceramic sheet.

[0120] Specifically, for example, the rotation angle of the pointer is positively correlated with the original amplitude of the reed 231. Therefore, the pointer angle is captured by an angle sensor (three-coil electromagnetic induction), and the corresponding vibration amplitude of the reed 231 is obtained based on a preset mapping table of pointer angle and vibration amplitude. The continuous voltage signal output by the angle sensor contains a time-domain waveform synchronized with the vibration of the reed 231. By analyzing the zero-crossing interval or the position of the main peak of the spectrum, the original vibration frequency can be directly calculated.

[0121] For example, piezoelectric ceramic sheets directly convert mechanical vibrations into electrical signals: the bending deformation of the reed 231 compresses the piezoelectric crystal, causing a change in its internal dipole moment and generating alternating charges. The instantaneous value of the charge is positively correlated with the bending amplitude of the reed 231. After being converted into a voltage signal by a charge amplifier, its peak voltage corresponds to the vibration amplitude. At the same time, the fundamental frequency of the voltage signal can also map to the vibration frequency of the reed 231. By detecting the periodic characteristics of the voltage waveform, and further combining it with a preset mapping relationship list between the voltage signal frequency and the vibration frequency of the reed 231, the frequency parameters can be obtained.

[0122] The above is a reference for a typical implementation process. In actual implementation, it is not limited to the above methods. Other existing technologies can be used to analyze and obtain the components and their corresponding principles of vibration amplitude and frequency, which is unrestricted.

[0123] The evaluation component is used to assess airway patency based on the rotation angle of the pointer.

[0124] Furthermore, such as Figure 5 As shown, the reed group 230 includes a plurality of reeds 231 arranged at intervals along the airflow direction, and the length of the reeds 231 decreases gradually along the airflow direction.

[0125] Setting the length of the reed 231 to decrease gradually along the airflow direction allows the airflow to gradually decelerate and change the pressure distribution as it passes through the duct. This helps reduce the impact force of the airflow on the reed 231, avoids excessive energy impact on a single reed 231, which could lead to measurement errors or damage to the reed 231, and enables a smoother transfer of the kinetic energy of the airflow to the reed 231, resulting in more stable vibration and improving the accuracy and stability of the measurement.

[0126] The different lengths of the reeds 231 mean that each reed 231 has a different natural frequency and resonant frequency. The natural frequency (f) of the reed 231 is inversely proportional to its length L, while its amplitude (A) is proportional to the force applied by the airflow.

[0127] Therefore, the long reed 231 has a lower natural frequency and a higher amplitude, and can vibrate at low gas flow rates, while the short reed 231 requires high flow rates to vibrate.

[0128] In actual use, the following situations exist: the patient's airflow velocity may vary depending on the intensity of breathing or the degree of obstruction. For example, the flow rate is low during quiet breathing and high during obstruction.

[0129] Secondly, when a patient exhales into the airflow channel multiple times, the flow rate of the airflow may vary each time.

[0130] Third, when the airflow channel has a funnel-shaped structure, the inner diameter at the front end is large and the inner diameter at the rear end is small. The airflow velocity tends to increase along the flow direction, and vinlet < voutlet.

[0131] Due to the gradient change in the length of the reeds 231, each reed 231 in the reed group 230 shares a portion of the kinetic energy from the airflow according to its length and position, enabling a wider range of responses to changes in airflow velocity and pressure. In the inlet region of the airflow channel, the longer reeds 231 preferentially respond to airflow with lower velocities. The shorter reeds 231 positioned further back respond to airflow with increased velocity as it flows deeper into the airflow channel, ensuring that the reeds 231 respond throughout the entire flow of air within the channel, covering a wider range of airflow velocities and reducing "blind spots."

[0132] The gradient length design makes the natural frequencies of each reed 231 significantly different (Δf large), avoiding the problem of resonant coupling that may occur when multiple reeds 231 have similar lengths and natural frequencies, leading to signal superposition or cancellation. This results in clearer vibration data and lower noise.

[0133] Optionally, it also includes a sound acquisition component, which is set in the airflow channel to acquire sound data such as frequency, amplitude, and volume when the reed 231 vibrates.

[0134] By analyzing the acoustic characteristics in the sound data, the vibration status of reed 231 is determined. Specifically, taking SPL as an example:

[0135] Unobstructed airway: Smooth airflow → Small amplitude and low frequency of reed 231 → Low SPL and concentrated spectrum.

[0136] Airway obstruction: Turbulence excites high-frequency vibrations → large amplitude and wide bandwidth → high SPL and dispersed spectrum.

[0137] Other evaluation criteria may refer to the following standards:

[0138] Small amplitude: The vibration amplitude of reed 231 is small because there is no strong interference from the airflow.

[0139] Low frequency: A lower vibration frequency indicates that the airflow is stable and uniform.

[0140] Concentrated frequency spectrum: The main frequency components on the spectrum are concentrated in the low-frequency range, and the bandwidth is relatively narrow.

[0141] To better collect sound data, in addition to selecting a material for the reed 231 that vibrates more easily to produce sound, such as a plastic sheet, the front end of the reed 231 can also be configured as follows: Figure 8 As shown, it is bifurcated, including several adjacent branches 232, which may be adjacent to each other or have a gap between them.

[0142] In addition to the vibration of the reed 231 itself, each branch 232 also vibrates independently, producing sound. This design makes it easier to collect and analyze sound signals, resulting in more complex sound signals with richer spectral components, thus providing more acoustic features for analysis.

[0143] Furthermore, such as Figure 6 As shown, it also includes an inflation assembly 300 disposed within the conduit body 200. The inflation assembly 300 includes a soft balloon 320, which is connected to the rear end 220 of the airflow channel via a one-way valve 310.

[0144] The airflow travels along the airflow channel and enters the balloon 320 through the one-way valve 310.

[0145] The one-way valve 310 can be a duckbill valve, umbrella valve, diaphragm valve, etc., which only allows gas to pass through in one direction and enter the soft balloon 320, but cannot leave the soft balloon 320.

[0146] The soft balloon 320 is designed to be relatively small, allowing it to expand with a small or even minute amount of gas, resulting in a bulging change on its outer surface.

[0147] For example, the soft balloon 320 is made of ultra-thin silicone material (thickness ≤ 0.1mm) to form a spherical capsule with a volume between 3-5ml.

[0148] It also includes a balloon 320 detection component, which is used to detect the expansion changes of the balloon 320.

[0149] In one embodiment, a piezoresistive thin-film sensor is attached to the surface of the balloon 320. When the surface of the balloon 320 expands, the thin film is stretched and deformed, resulting in a change in the film's resistivity. By collecting the film's resistivity and based on the amount of resistivity change, and according to a preset mapping relationship between the resistivity change and the degree of balloon 320's expansion, the degree of balloon 320's expansion is determined.

[0150] In another embodiment, a pair of concentric annular flexible electrodes are attached adjacent to the inner wall of the balloon 320. When the balloon 320 inflates, the inner wall expands outward, which increases the spacing between the electrodes and the area of ​​the annular electrodes as they unfold and deform, resulting in an increase in the total capacitance. By collecting the changes in capacitance, and based on a preset mapping relationship between capacitance changes and the degree of inflation of the balloon 320, the degree of inflation of the balloon 320 is determined.

[0151] The evaluation component is used to assess airway patency based on the expansion changes of balloon 320.

[0152] Set a sampling time, such as 5-10 minutes. At the start of sampling, record the initial resistivity or capacitance value of balloon 320 as initial state data. During the sampling time, continuously monitor the changes in resistivity or capacitance of balloon 320 and record the data for each measurement. After the sampling time has elapsed, compare the final resistivity or capacitance value with the initial state to obtain the degree of inflation of balloon 320. Based on the mapping relationship between the degree of inflation of balloon 320 and airway patency, obtain the assessment result of airway patency.

[0153] As an example rather than a limitation, for instance, if balloon 320 inflates by 0-10% during the sampling period, it indicates severe airway obstruction.

[0154] Balloon 320 inflated by 10-30% during the sampling period, indicating moderate airway obstruction.

[0155] Balloon 320 inflated by 30-60% during the sampling period, indicating mild airway obstruction.

[0156] Balloon 320 inflated by more than 60% during the sampling time, indicating that the airway was clear.

[0157] In addition, based on the known size data of balloon 320 and the degree of inflation of balloon 320, the total amount of gas entering balloon 320 can be obtained.

[0158]

[0159] Where V0 is the initial volume of balloon 320, and r0 is the initial radius of balloon 320.

[0160] V t The volume of the terminating balloon is 320, r t It is the terminating balloon with a radius of 320.

[0161] The total amount of gas collected during the sampling period can also be used to determine the level of airway patency. A larger total amount of gas during the sampling period indicates better airway patency.

[0162] Optionally, such as Figure 7 As shown, the balloon 320 detection assembly also includes a rigid frame 330 capable of accommodating the balloon 320; in the initial state, the outer peripheral surface of the balloon 320 may not contact the inner side of the rigid frame 330 at all, and there is a gap between the balloon 320 and the inner side of the rigid frame 330.

[0163] Alternatively, the outer peripheral surface of balloon 320 may partially contact rigid frame 330.

[0164] Alternatively, the outer surface of balloon 320 may be in complete contact with rigid frame 330.

[0165] In any of the above initial states, the outer surface of the balloon 320 can contact the inner side of the rigid frame 330 during the expansion process and apply pressure to the inner side. Optionally, a soft layer is provided on the inner side of the rigid frame 330, which can be compressed inward under the pressure applied by the expansion of the balloon 320.

[0166] A pressure sensor 340 is provided on the inner side of the rigid frame 330 facing the balloon 320 to collect the pressure exerted by the outer surface of the balloon 320 on the inner side of the rigid frame 330.

[0167] The evaluation component assesses airway patency based on pressure data collected by pressure sensor 340.

[0168] Specifically, for example, with a sampling time of 10 minutes, the pressure sensor 340 records pressure data once per second, resulting in 600 data points.

[0169] The average pressure data was calculated. The average pressure data over the sampling time reflects the rate of pressure rise within the fixed volume of balloon 320, and is positively correlated with the degree of airway obstruction. When the airway is open, the patient's exhaled airflow diffuses smoothly, and the pressure entering balloon 320 rises slowly, resulting in a lower average pressure data.

[0170] Set pressure thresholds corresponding to different airway patency levels. The following values ​​are illustrative; specific values ​​need to be calibrated and adjusted based on actual experimental data:

[0171] Average pressure P < 0.5 Pa: The airbag inflates uniformly, corresponding to an unobstructed airway.

[0172] 0.5 ≤ average pressure P < 1.0 Pa: mild airway obstruction.

[0173] 1.0 ≤ average pressure P < 1.5 Pa: moderate airway obstruction.

[0174] 1.5 ≤ mean pressure P < 2.0 Pa: severe airway obstruction.

[0175] The present invention provides a system for assessing airway patency using an assessment device as described in any one of the above-described methods.

[0176] Within the scope of this disclosure, terms such as “comprising” should be interpreted by default as inclusive or open-ended, rather than exclusive or closed, unless expressly defined as such. All technical, scientific, or other terms shall be interpreted as understood by one of those skilled in the art, unless defined as such. Public terms found in dictionaries should not be interpreted in an overly idealistic or impractical manner in the context of the relevant technical documentation, unless expressly defined as such in this disclosure.

[0177] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0178] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. An airway patency assessment device, characterized in that: Includes catheter body (200), measurement components, and evaluation components; The catheter body (200) is trumpet-shaped with openings at both ends. The larger diameter end is the exhalation port (210), and the smaller diameter end is the outlet port (220). An airflow channel is formed between the exhalation port (210) and the outlet port (220). Gas enters the airflow channel through the exhalation port (210) provided on the catheter body (200). A reed assembly (230) is provided on the inner wall (201) of the conduit body. The reed assembly (230) includes at least one reed (231), which is capable of vibrating when in contact with airflow. The measuring component is used to collect vibration data of the reed assembly; The evaluation component is used to assess airway patency based on vibration data collected by the measurement component.

2. The airway patency assessment device according to claim 1, characterized in that: The reed assembly (230) adopts any of the following structural configurations: Method 1: The reed assembly (230) includes multiple polypropylene film reeds, each polypropylene film reed having a thickness of 0.05 mm to 1 mm, symmetrically arranged on the inner wall (201) of the conduit body; when airflow passes through, the polypropylene film reeds can undergo bending vibration; Method 2: The reed group (230) includes multiple reeds, each made of medical-grade silicone material with a thickness of 0.2 mm, arranged in a fan shape; the root of each reed is fixed to the inner wall of the catheter body, and the free end is arranged at an angle towards the airflow direction, which can generate multi-frequency vibration under the action of expiratory airflow; Method 3: The reed assembly (230) includes multiple polyethylene sheet reeds, each with a thickness in the range of 0.08-0.15mm, arranged in a spiral shape on the inner wall of the duct body. This arrangement can generate vortices in the airflow. Method 4: The reed assembly (230) includes multiple polyurethane film reeds with a thickness of 0.1 mm and micro-protrusion structures on the surface; each reed is distributed asymmetrically on both sides of the channel, and can generate differential vibration when airflow passes through, which facilitates multi-dimensional evaluation of airflow characteristics; Method 5: The reed assembly (230) includes multiple reeds made of biocompatible PET film, each reed being 0.05-0.3 mm thick and arranged in a grid pattern; Method 6: The reed assembly (230) includes multiple reeds, each reed being made of multi-layer composite material, with each single layer of the reed having a thickness of 0.01-0.02 mm and a total thickness not exceeding 0.3 mm; Method 7: The reed group (230) includes multiple reeds, each reed adopting a master-slave reed structure. The master reed (231-1) is connected to multiple tendril-shaped auxiliary reeds (231-2). When the master reed (231-1) is pushed by a weak airflow, the auxiliary reeds (231-2) generate secondary amplified vibration. Method 8: The reed group (230) includes a plurality of reeds (231) arranged sequentially at intervals along the airflow direction, and the length of the reeds (231) decreases gradually along the airflow direction. Method 9: The reed group (230) includes multiple reeds, each reed having a forked front end, including several adjacent forks, which are either close together or spaced apart.

3. The airway patency assessment device according to claim 1, characterized in that: The connection between the reed (231) and the inner wall (201) of the catheter body can be at least one of the following: The first method involves a connecting part made of a hot-melt material at the bottom of the spring, which positions the spring at preset grid points on the inner wall, and then the connecting part is placed under heating conditions to achieve hot-melt fixation. The second type has a groove on the inner wall of the airflow channel, and a corresponding locking tooth on the root of the reed is provided to match the groove; the locking tooth is embedded in the groove to achieve a fixed connection between the root of the reed and the inner wall of the airflow channel. The groove and the tooth can be connected in two ways:

1. The groove and the tooth are perfectly matched, and the tooth is embedded in the groove without any additional movement space; 2. The groove has a certain longitudinal length, which is equivalent to a slide rail. After the tooth is embedded in the groove, it can move within the length of the groove. When airflow passes through the airflow channel, the airflow will exert a pushing force on the reed, which may guide the reed to produce a slight displacement in the direction of airflow. A corresponding displacement sensor is set up to collect the displacement data of the reed and send it to the evaluation module as one of the reference factors for subsequent airway patency assessment. The third type involves connecting the spring to the inner wall of the conduit body via a fixing component.

4. The airway patency assessment device according to claim 3, characterized in that: In the third connection method, the fastener can be either a base or an elastic clamping structure; When the fixing component is a base, the base is fixedly connected to the inner wall of the conduit body. The top or side of the base is provided with a slot that matches the bottom of the spring. The connection is achieved by inserting the bottom of the spring into the slot. After the bottom of the spring is inserted into the slot, the locking mechanism is hinged to both sides of the slot. The locking component rotates inward and presses the two sides of the spring, further strengthening the fixation of the spring in the slot. While the bottom of the spring remains fixed in the slot, the other parts of the spring are exposed outside the slot, so that they can come into contact with the airflow and vibrate when the airflow passes through the airflow channel. When the fixing component is an elastic clamping structure, the inner surface of the fixing component is provided with anti-slip texture. After the spring is pushed in laterally from the opening of the clamping component, the clamping arm relies on the rebound force to tighten and clamp the spring, thereby fixing the spring to the inner wall of the conduit body.

5. The airway patency assessment device according to claim 1, characterized in that: The measuring component includes a vibration amplification structure connected to a reed drive; the vibration amplification structure includes at least an L-shaped rocker arm, one end of which is hinged to a reed, and the other end is connected to a gear set; the gear set includes a sector gear connected to the L-shaped rocker arm, and a planetary gear system meshing with the sector gear, for reducing the rotational speed of the sector gear and increasing the torque.

6. The airway patency assessment device according to claim 5, characterized in that: The pointer is fixed to the end of the output shaft of the gear set, and the rotation angle of the pointer is positively correlated with the amplitude of the spring. An angle sensor is used to measure the rotation angle of the pointer; The evaluation component is used to assess airway patency based on the rotation angle of the pointer.

7. The airway patency assessment device according to claim 1, characterized in that: The measuring component includes a piezoelectric ceramic sheet disposed at the root of the reed, which can generate an electric charge signal when the reed vibrates; The evaluation component is used to assess airway patency based on charge signals.

8. The airway patency assessment device according to claim 1, characterized in that: It also includes an inflation assembly located at the air outlet (220), the inflation assembly comprising a soft balloon connected to the air outlet (220) via a one-way valve; the one-way valve only allows gas to enter the soft balloon through the airflow channel; It also includes a balloon detection component, which is used to detect changes in the inflation of a balloon; The evaluation component is used to assess airway patency based on changes in balloon inflation.

9. The airway patency assessment device according to claim 1, characterized in that: The balloon detection assembly also includes a rigid frame capable of accommodating the balloon; the outer surface of the balloon is able to contact the inner side of the rigid frame during inflation. A pressure sensor is installed on the inner side of the rigid frame facing the balloon to collect the pressure exerted by the outer surface of the balloon on the inner side of the rigid frame.

10. A method for assessing airway patency, characterized in that: Airway patency is assessed using the airway patency assessment device as described in any one of claims 1-9.

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