Dynamic quantification method for swallowing ability based on gel gradient of dissolvable food

Abstract

The invention relates to a dissolvable food gel gradient-based swallowing ability dynamic quantification method, which comprises the following steps of: constructing a microstructure unit consisting of an instantaneous surface attachment area and a middle-stage debonding layer in dissolvable food gel, and simulating early-stage sensing delay and middle-stage release response in a swallowing process; different material behavior reactions are generated in the front stage, the middle stage and the rear stage of swallowing by regulating and controlling the hydration diffusion rate, the surface tension and the internal cohesion difference value of the gel, and the gel of each stage corresponds to the set micro-viscosity and release coupling ratio, so that swallowing strategies of different stages are adapted; controllable disintegration temperature-sensing microparticles or traceable microcapsules are partially embedded in the food gel, the food gel is detained in a pharyngeal cavity after being swallowed, and the removal efficiency after swallowing is detected according to migration behaviors within a set time window; after swallowing, the reduction behaviors of the oral cavity, the tongue body and the throat muscle group are monitored, and when the characteristic action of reduction delay, secondary mouth opening, repeated swallowing or pharyngeal itching occurs, it is judged that the swallowing behavior closed loop is interrupted.

Description

TECHNICAL FIELD

[0001] The present application relates to the development and clinical application of swallowing ability quantitative evaluation and related medical food system, in particular to a dynamic quantitative method for swallowing ability based on soluble food gel gradient. BACKGROUND

[0002] At present, the existing technology such as Chinese patent CN108144066A gel structure for assisting swallowing oral solid drug, the invention designs gel material from the perspective of formula food, mainly solves the problems of insufficient lubricity, too high gel strength or poor taste in the process of swallowing, to a certain extent, provides an auxiliary swallowing means for people with difficulty in swallowing (such as the elderly and children), especially in the scene of drug intake, emphasizes the balance of wrapping, taste masking and rapid disintegration performance. However, its existing scheme obviously still has many technical drawbacks such as single structure, limited functional response and insufficient dynamic behavior capture, which is difficult to meet the requirements of multi-dimensional time sequence, physiological interaction and behavior identification of the present application.

[0003] Firstly, the patent focuses on swallowing assistance, and the gel mainly serves as a drug carrier, which plays a role similar to synovial membrane or coating in swallowing by constructing specific physical properties such as wrapping, lubrication and rapid disintegration. Its original intention does not have the ability to intervene and identify the individual swallowing behavior in stages; its structure is a single homogeneous gel system, the gel rapidly disintegrates at the temperature of the oral cavity, and does not introduce a structure-function partition design, lacking the ability to induce the "pre-middle-post" process of swallowing action. Secondly, the functional behavior of the gel in the invention is a static one-way release type, that is, once it enters the oral cavity, it rapidly releases its physical properties (such as lubrication, hydration, and disintegration), and cannot adjust the response time window or behavior feedback path, so it cannot monitor or quantify key indicators such as the length of the individual's swallowing reaction, reaction delay, and whether the swallowing closed loop is complete. Thirdly, the behavior of the gel structure in the invention only faces the one-time physical passage from the oral cavity to the pharynx, and does not have the ability of behavior response amplification and feedback, and cannot monitor whether non-swallowing behaviors such as clearing the throat and low-frequency sound can activate the residual clearance path of the pharynx.

[0004] In addition, from the method dimension, the invention focuses on improving the swallowing experience, and the evaluation standard still stays at traditional material performance parameters such as the strength, taste masking, lubricity, and water retention rate of the gel, and there is no complete behavior identification chain or data modeling support, so it cannot be used as a swallowing ability quantitative method for clinical identification and dynamic tracking.

[0005] In summary, although the prior art has certain practical value in the field of assisted swallowing, it has single structure and function, lacks response control and partition monitoring capability for the process of swallowing behavior, and cannot support accurate judgment of whether the closed loop after swallowing is completed, and cannot meet higher dimensional demands such as swallowing disorder identification, rehabilitation path screening and dynamic swallowing function monitoring. SUMMARY

[0006] The purpose of the present application is to provide a dynamic quantification method of swallowing ability based on a soluble food gel gradient, so as to solve some of the problems and deficiencies pointed out in the background art.

[0007] The technical scheme adopted by the present application to solve the above technical problems is as follows: a dynamic quantification method of swallowing ability based on a soluble food gel gradient, comprising: constructing a microstructure unit composed of a transient surface adhesion zone and a mid-term dissociation layer in a soluble food gel, so as to simulate the perception delay in the initial stage and the release response in the mid-term during swallowing; by adjusting the hydration diffusion rate, surface tension and internal cohesive force difference of the gel, different material behavior responses are generated in the pre-swallowing, mid-swallowing and post-swallowing stages, each stage of the gel corresponds to a set of micro-viscosity and release coupling ratio, so as to adapt to the swallowing strategy in different stages; When an individual swallows the gel, the time delay between the gel retention and the occurrence of the swallowing action is collected, and the delay is controlled by the design of the micro-adhesion structure; and a non-invasive monitoring method including a mandibular motion sensor, a laryngeal position sensor or an acoustic reflection analysis is used to record the starting time point of the swallowing action in real time; Part of the food gel is embedded with controllable disintegrating temperature-sensitive micro-particles or traceable micro-capsules, the micro-particles are retained in the pharyngeal cavity after swallowing, the clearance efficiency after swallowing is detected according to the migration behavior within a set time window, and whether the residual can be removed by non-swallowing action such as coughing or clearing the throat is observed; After swallowing, a non-contact action capture device including acoustic analysis, vibration monitoring or image recognition is used to monitor the reset behavior of the oral cavity, tongue and laryngeal muscle group, when reset delay, secondary mouth opening, repeated swallowing or characteristic action of pharyngeal itching occurs, it is determined that the swallowing behavior closed loop is interrupted, so as to comprehensively evaluate the integrity of the individual's swallowing function and the dynamic ability state.

[0008] Further, the food gel is composed of multiple layers of microstructure, including a delay adhesion zone provided on the outer layer and a stage dissociation zone provided on the inner layer; the delay adhesion zone is composed of a material with short-time biological adhesion performance, forming a transient adhesion state in the oral cavity to delay the perception of swallowing trigger; The phase dissociation zone has temperature responsiveness and structure disintegrability, and is configured to achieve controllable structure disintegration after the gel enters the pharynx, to promote the gel to advance and be easily cleared after swallowing; the food gel structure is formed by adjusting the local thermal responsiveness of the multi-phase hydrogel matrix and controlling the spatial distribution characteristics, to form three types of material response behaviors of perception initiation, channel crossing and residual clearance at the pre-, mid- and post-swallowing stages, respectively.

[0009] Further, a gradual interface layer is arranged between the delayed adhesion zone and the phase dissociation zone, which exhibits time-delayed interface dissolution behavior after saliva contact, for adjusting the transition rate of structure response between the two zones; heat-sensitive color-changing microparticles or edible fluorescent marker particles are dispersed in the phase dissociation zone, which can be used to track whether the gel is completely cleared after swallowing, to assist in evaluating the residual behavior in the pharyngeal cavity.

[0010] Further, the delayed adhesion zone forms an adhesion state at the temperature of the oral cavity, but can instantaneously lose adhesion under the mechanical action of the tongue or the intervention of liquid, to induce the subject to have an autonomous swallowing reaction after perceiving the delay; the gel structure is configured to be continuously applied multiple times, and presents a variation trend of adhesion response or disintegration response after each use, for identifying the swallowing action fatigue window or functional degradation performance of the individual through multiple swallowing tests.

[0011] Further, the food gel includes a main body with controllable disintegration structure and embedded marker response particles; the marker response particles are released after the individual completes the swallowing action and are retained in the pharyngeal cavity; the system is provided with an observation time window, which indicates a time period from the completion of swallowing to a predetermined delay detection endpoint, and the migration or residual behavior of the marker response particles is detected in the time window by a non-invasive method, for evaluating the natural clearance efficiency of the pharyngeal cavity after swallowing.

[0012] Further, the marker response particles have self-migration ability after sensing the disturbance of mucosal fluid, and the marker response particles exhibit traceable displacement behavior under the influence of micro-liquid flow or spontaneous muscle movement of the pharyngeal cavity, for amplifying the response signal of the clearance action; the time window is divided into multiple observation stages, the position change of the marker response particles is recorded in different stages, and whether there is a decay or delay trend in the clearance efficiency of the pharyngeal cavity is judged according to the time delay or response speed of the particle migration; In order to quantify the self-migration behavior characteristics of the marker response particles in the pharyngeal cavity caused by micro-amplitude muscle disturbance or liquid flow stimulation, and further enhance the recognition accuracy of the post-swallowing clearance ability, a time-segmented migration function modeling method based on dynamic disturbance response is adopted; in the set observation time window , the spatial migration response of the particles can be represented by a first-order disturbance integral function , which is of the form: wherein: is the observation period, defined as the dynamic monitoring period set after the completion of swallowing; is the disturbance amplitude function on the mucosal surface of the pharynx per unit time; is the liquid flow perturbation function, representing the diffusion intensity of natural secretion or externally introduced liquid in the pharynx after swallowing; is the low-amplitude coordination rate function of the pharyngeal muscle, used to measure the level of autonomous micro-muscle activity; is the spatial displacement of the marker response particles per unit time at the microscale; is the total disturbance migration function value, representing the dynamic potential energy of the cumulative response migration behavior of the particles before the observation time point; is the threshold function, if , it is determined that the pharynx has an effective non-swallowing clearance response in the observation period; if , it is prompted that the pharyngeal clearance function may have a delay, local residue or micro-motion dysfunction.

[0013] Further, after the end of the time window, the individual is guided to perform a non-swallowing action, and by comparing the spatial distribution change of the marker response particles before and after the non-swallowing action, it is determined whether the individual has an activated auxiliary clearance mechanism.

[0014] Further, the marker response particles are coated in a delayed release shell, which breaks or unpacks after a period of time after the swallowing action, so that the particles are released with a lag and avoid being completely taken out along the main swallowing path, so that the particles enter the non-swallowing clearance stage for behavior detection.

[0015] Further, the marker response particles are grouped into particles with different disintegration thresholds, each group is positioned at a different disintegration point in the pharynx, and is used to identify the residual migration trajectory of the upper pharynx, middle pharynx and lower pharynx region in the observation time window, respectively.

[0016] Further, the individual is guided to perform low-frequency vocalization, nasal air puffing or breath vibration light voluntary action in the observation time window, and the clearance responsiveness of the pharynx to the micro-amplitude muscle movement is judged by detecting the response behavior of the particles.

[0017] ​The beneficial effects of the present application: by designing a multi-layer food gel with delayed adhesion, gradual dissociation and partitioned response structure, the three key links of pre-swallowing perception start, swallowing channel propulsion and post-swallowing residue removal are precisely separated and dynamically observed, breaking through the limitations of traditional evaluation relying on single reaction time or subjective score. Using the adhesion performance, hydration response, heat-sensitive dissociation, and delayed disintegration of the material itself, the subject is guided to perform natural swallowing action and trigger responses at each stage, making the evaluation process independent of active instruction input, thereby obtaining more realistic and continuous swallowing performance. By embedding delay-release sensing particles and combining non-invasive monitoring techniques (such as image tracking, fluorescence imaging, etc.), the present application first systematically introduces the identification and tracking mechanism of non-swallowing auxiliary removal ability, providing technical basis for the integrity judgment of the post-swallowing closed loop, filling the blind area of traditional methods for residue path identification.

[0018] Through continuous swallowing multiple tests, combined with the change of response strength of the gel structure in sequence, the quantitative trend of swallowing delay, disintegration speed and removal ability of individuals in different rounds can be identified, providing support for judging the critical point of swallowing fatigue or the window of function degradation. The gel microstructure, particle grouping, release delay and adhesion parameters can be adjusted as needed, suitable for different populations (such as neuro-rehabilitation patients, elderly population, and pharyngeal muscle atrophy) and various scenarios (basic screening, rehabilitation training, efficacy evaluation, etc.). Without intubation and radiation, based on edible gel and non-contact behavior recognition technology, it is suitable for high-frequency dynamic monitoring and long-term tracking intervention, significantly improving the acceptability and data stability of clinical application. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 Flowchart of the present application for dynamic quantification of swallowing ability.

[0020] Figure 2 Flowchart of the present application for dynamic quantification of swallowing function driven by multi-layer gel structure.

[0021] Figure 3 Flowchart of the present application for dynamic quantification and grading of post-swallowing pharyngeal cavity removal ability.

[0022] Figure 4 Schematic diagram of the present application for swallowing evaluation process of three-layer microstructure food gel in embodiment 1.

[0023] Figure 5 Schematic diagram of the present application for post-swallowing particle tracking and partitioned auxiliary removal ability evaluation process in embodiment 2. DETAILED DESCRIPTION

[0024] The specific embodiments of the present application will be described in detail below with reference to the accompanying drawings.

[0025] Combined with the accompanying Figure 1The application provides a swallowing ability dynamic quantification method based on a soluble food gel gradient. By constructing a multi-level and stage responsive gel microstructure, quantitative identification and hierarchical evaluation of behavior feedback in the whole swallowing process are achieved. Edible hydrogel materials (such as gelatin, alginate, konjac polysaccharide, etc.) are used as the base, and through phase control and structure template control process, a multifunctional microstructure unit composed of a transient surface adhesion zone and a medium-term loose layer is constructed inside the same gel unit. The transient surface adhesion zone is set by local hydrophilic molecular segments or low-concentration weakly adherent polymer domains, so that the gel produces a transient but not persistent slight adhesion when it contacts the oral epithelium or the tongue surface, thereby delaying the trigger time point of the swallowing reflex, achieving the purpose of simulating the initial perception delay state of swallowing; the medium-term loose layer is composed of a heat-sensitive or shear-sensitive weak cross-linked structure. After the swallowing action is started, the layer enters the pharyngeal cavity environment and is affected by temperature, pressure or muscle extrusion, and the structure is loose or stage disintegration occurs, thereby releasing part of the gel fragments or embedded components, simulating the release process of active sliding and decomposition in the middle stage of swallowing, so that the pushing behavior in the swallowing process has a perceptible load change; in order to ensure the difference and controllability of the gel response in different stages, the relative difference between the hydration diffusion rate, surface tension and internal cohesion of the gel is further accurately controlled to realize the separation of the response window. The hydration diffusion rate is controlled by the polysaccharide cross-linking density and local water content in the gel, which is used to control the swelling effect time of the gel under the action of saliva; the surface tension is adjusted by adding a small amount of surfactant peptide or protein regulator in the surface layer to affect the sliding starting behavior of the gel on the mucosal surface; the internal cohesion is mainly determined by the cross-linking strength of the gel backbone, which is used to maintain the shear stability of the overall structure of the gel, and maintains an appropriate degree of depolymerization in different response stages, so that the gel exhibits characteristic material behavior in each stage of pre-swallowing (oral retention), swallowing (pharyngeal passage) and post-swallowing (clearance and disintegration); on this basis, according to the physical response characteristics of each microstructure layer of the gel, it is classified into multiple gradient levels, and each level of gel is set with specific micro-stick parameters and structure release rate coupling ratio, so that it exhibits different response difficulty and behavior feedback in the use process of individuals with different swallowing ability levels, such as low-grade gel which exhibits fast dissipation, low adhesion and easy clearance, and high-grade gel which exhibits delayed perception, slow release sliding and partial retention, etc. characteristic reaction, thereby forming a standardized gel sample sequence that can be used to quantitatively evaluate the difference in swallowing ability, and finally realizing the dynamic classification and process quantification of swallowing ability in different populations and different states.

[0026] For the identification and quantitative evaluation of the delay of swallowing behavior initiation, a detection mechanism with swallowing trigger time as the core index is designed. When the individual contacts the set level of dissolvable food gel in the oral cavity, the short-term mild adhesion force generated by the micro-adhesion structure constructed on the surface of the gel makes the gel form a retention behavior on the surface of the oral mucosa or tongue. The duration of this retention behavior is controlled by the adhesion modulus of the gel surface, the distribution of local hydrophilic components and the mucosa wetting state, which in turn affects the trigger time point of the swallowing reflex. To realize the real-time capture of the dynamic process from gel retention to swallowing initiation, a multi-modal non-invasive sensing method is used for synchronous detection, including mandibular movement sensors placed on both sides of the lower jaw or the lower jaw edge, which are used to identify the muscle pre-contraction signal before the initiation of swallowing movement; displacement type adhesive laryngeal position sensors placed outside the laryngeal prominence or cricoid cartilage area, which are used to accurately monitor the initiation time points of key physiological actions such as laryngeal elevation, pharyngeal constriction and epiglottic reflex; and a miniature sound wave reflection analysis module arranged on the face or the front of the neck, which is based on the detection of acoustic disturbance characteristics generated by glottis closure and pharyngeal cavity channel compression through high-frequency micro-vibration signal changes, to identify the occurrence node of swallowing execution action. The above three types of non-invasive monitoring signals can be used alone or in combination, and after being associated with the information of the swallowed gel level, the time delay value between the gel contacting the oral cavity and the swallowing initiation in the whole process of swallowing behavior is recorded. This delay time parameter can be used as a key evaluation index to reflect the individual swallowing reflex threshold, action initiation coordination and adhesion sensitivity. Combined with the test performance of multi-gradient gels in different individuals or at different time points of the same object, early identification data of the change trend of swallowing ability can be formed, which can be used for the typing analysis of swallowing disorders, pre-evaluation of rehabilitation intervention or verification of therapeutic effect feedback.

[0027] To achieve quantitative evaluation of the ability of the pharyngeal cavity to clear after the completion of swallowing behavior, controllably disintegrating temperature-sensitive micro-particles or traceable micro-capsules are designed to be embedded in food gels. The particles are based on temperature-responsive materials or edible fluorescent, colorant, and biological tracer components, which are embedded in the inner structure of the gel and can be released in order under the action of body temperature or the shear environment generated by the contraction of the swallowing muscle after the gel enters the pharyngeal cavity. The released particles have a diameter range of 5-50 microns, which cannot stimulate the pharyngeal nerve and is not easy to be inhaled with the airway, and at the same time has the physical properties of stable retention in different regions of the pharynx (including the upper pharynx, the middle pharynx, or the junction of the lower pharynx) for a short time. A detection time window ΔT is set after the completion of swallowing, which is usually 30 seconds to 90 seconds. Within this observation time window, whether the micro-particles or capsules migrate, dissolve, or change position in the pharyngeal cavity is observed by using non-invasive visualization detection methods (such as fluorescence excitation imaging, digital endoscopic illumination, or external irradiation identification), so as to judge whether the pharyngeal cavity has sufficient natural clearance ability after the completion of the swallowing action. If the particles stably migrate to the lower pharynx or are completely absorbed within the time window, it indicates that the risk of pharyngeal cavity residue is low. If the particles remain in place for a long time or accumulate on the pharyngeal wall, it indicates that there are risk factors such as insufficient pharyngeal power, weakened mucociliary transport, or limited residual clearance path. In addition, to further detect whether the individual has auxiliary clearance function in a non-swallowing state, the individual is guided to perform at least one non-swallowing action at the later stage of the observation period, including light cough, clearing the throat, or actively making a sound. Whether the particles displace, disperse, or discharge due to air flow disturbance, muscle coordination, or gravity action after the action is recorded, so as to judge whether there is a compensatory pharyngeal clearance mechanism. This mechanism is particularly suitable for auxiliary ability screening of people with limited swallowing reflex or insufficient muscle strength. This method can be used in conjunction with different levels of food gels to associate the particle release position, migration speed, and clearance state with the swallowing level, thereby forming a behavior closed-loop model integrating swallowing completion-residual dynamics-clearance feedback, which is helpful for multi-dimensional quantification of individual swallowing function from the perspective of the complete swallowing period and output of rehabilitation intervention recommendations.

[0028] To achieve systematic evaluation of the functional closed-loop state after the completion of swallowing behavior, a non-contact motion capture device containing acoustic analysis, vibration monitoring and image recognition was designed and applied to continuously track the resetting behavior of the individual's oral cavity, tongue and laryngeal muscle group after the completion of swallowing. The non-contact system is installed in front of the subject's head or in the mandibular area, and the resting behavior interval within 0-10 seconds after swallowing is monitored at high frequency. The acoustic analysis module records the weak airflow changes, secondary cough sounds, oral cavity closing sounds and tongue base return audio features through a short-range microphone array. The vibration monitoring module captures the reflective displacement response of the laryngeal prominence, mandible or anterior neck muscle group based on laser or micro-distance millimeter wave detection technology. The image recognition module uses an AI labeling model to analyze facial muscle tension changes, mouth shape contraction degree, mandibular re-opening angle and tongue tip displacement trajectory in real time. Through the fusion of three signals, it is determined whether the swallowing behavior enters the resting state. If secondary mouth opening, repeated tongue movement, unstable mandibular closure, repeated swallowing, or obvious pharyngeal itching occurs within the set time, it is marked as abnormal resetting after swallowing by the system, and the closed loop of this swallowing behavior is determined to be interrupted. The criteria for closed loop interruption include but are not limited to: (1) muscle group continues to be tense or action fluctuates after swallowing is completed beyond the expected time; (2) there are repetitive pharyngeal starting actions in the sound or image signals; (3) non-autonomous compensation actions such as clearing the throat, opening the mouth, and tongue contraction fail to enter the resting state; this behavior feature can comprehensively reflect whether the individual has central control delay, muscle recovery coordination disorder or swallowing signal residual discharge phenomenon in the late stage of swallowing, and thus serves as a key physiological parameter for identifying potential functional swallowing disorders or unstable swallowing ability. This method, combined with the test sequence of different gradient levels of dissolvable gel, can establish a three-stage closed-loop evaluation chain of structure-action-recovery, which helps clinicians evaluate the integrity of swallowing function while making more granular typing judgments and personalized intervention designs for the individual's dynamic ability state.

[0029] Combined with the attached Figure 2To realize the hierarchical induction and response feedback of physiological mechanism in different stages of the whole swallowing behavior, a food gel system composed of multi-layer microstructure is designed and constructed, which includes a delayed adhesion zone in the outer layer and a staged dissociation zone in the inner layer. The delayed adhesion zone is composed of edible polymer materials with short-time biological adhesion properties, such as weakly cross-linked gelatin, sodium carboxymethyl cellulose complex or moderately acetylated chitosan, which has controllable adhesion characteristics of hydrophilic but low viscous, and can form a transient adhesion state with the tongue or oral mucosa inside the oral cavity. This adhesion effect can be maintained for 1-5 seconds under human control, so that the food gel will not immediately slide or start the swallowing reflex after entering the oral cavity, thereby delaying the individual's swallowing trigger perception. This design makes the pre-swallowing voluntary action or reflex threshold a controllable test variable. The staged dissociation zone is located in the internal core area of the food gel, which is composed of a class of polysaccharides or heat-sensitive gel matrix with temperature responsiveness and structural disintegration ability, such as polyvinyl alcohol / sodium alginate copolymer network or chitosan / β-glycerophosphate sodium mixture. Its structure will undergo directional disintegration after encountering body temperature stimulation (such as ≥37℃) or being subjected to the action of tongue pressure and pharyngeal constrictor shear force, and in the designed structure, this zone shows softening first, then dissolving or fragmenting to release, thereby realizing smooth passage and flow lubrication in the middle of swallowing, avoiding pharyngeal retention or discomfort, and the particles or gel fragments after disintegration can be further pushed or naturally absorbed in the pharynx, which helps to achieve rapid clearance after swallowing. To realize the spatial organization of the material properties of the above two regions and the functional level cooperation, a multi-phase hydrogel matrix with local thermal responsiveness is further adjusted to form a gradient distribution structure between the layers. In the gel preparation process, temperature gradient injection method or phase separation molding technology is used to make the outer layer form a low cohesive and fast response structure, and the inner layer form a high cohesive and delayed dissociation structure, so as to induce different response behaviors of the material in the three key stages of swallowing behavior, i.e. perception and start before swallowing, passage crossing in the middle of swallowing, and residual clearance after swallowing. For example, before swallowing, when the individual faces the slight adhesion retention brought by the delayed adhesion zone, the pharyngeal reflex needs to reach a certain perception threshold to start, which can be used to detect the central swallowing trigger ability. In the middle of swallowing, the structure of the staged dissociation zone denatures and disintegrates under the action of body temperature or pressure, which can be used to evaluate whether the muscle compression and coordinated propulsion force is sufficient. After swallowing, whether the residual structure can be quickly cleared depends on the self-sliding property of the particle after disintegration and the efficiency of the oral-pharyngeal cavity muscle group reset, which can be used to identify whether the swallowing residual clearance function is intact, thereby realizing the dynamic quantitative evaluation method of whole-cycle swallowing ability driven by the gel structure configuration.

[0030] To optimize the response continuity of the multi-layered gel structure between different stages of swallowing and achieve the visual feedback evaluation of the pharyngeal cavity clearance state, a combination structure of delayed adhesion zone and staged dissociation zone is adopted, and a gradual interface layer is provided between the two, which is composed of a hydrogel material with a transition gradient distribution of viscoelasticity and hydrophilicity, specifically including an intermediate structural region constructed with different cross-linking densities, different hydrophobic segments or pH-responsive monomers. After contacting with saliva or the warm and humid environment in the oral cavity, the structure has a controllable delayed dissolution behavior, which can not only avoid the destruction of the outer delayed adhesion zone structure in a short time, but also provide a slow-release starting condition for the depolymerization process of the inner staged dissociation zone, so that the whole gel reaction from surface adhesion to core release forms a continuous and controllable transition behavior on the time axis, preventing the response mutation of the material from causing swallowing action interruption or discomfort. At the same time, further introduce microparticles or edible fluorescent marker particles with thermosensitive color change characteristics into the staged dissociation zone, which are selected from low-dose thermochromic pigment-loaded microspheres, food-grade fluorescein-embedded gel or protein-sensitive dye-encapsulated particles, with a particle size range of 10-80 microns, embedded into the dissociation zone matrix, released into the pharyngeal cavity during the swallowing process as the gel structure gradually disintegrates under the conditions of pharyngeal temperature and mechanical disturbance, and retained in the local area within a short time after swallowing. Through external excitation light irradiation, fluorescence detection device or naked eye observation of color change reaction, etc., the particle distribution state is tracked to assist in judging whether the gel is completely pushed forward and cleared in the pharyngeal cavity. If the particles are detected to be continuously retained or slowly change in position, it indicates that the pharyngeal clearance efficiency is decreased or the pharyngeal propulsion capacity is limited. If the particles quickly disappear or migrate after swallowing is completed, it indicates that the swallowing power system functions well. The introduction of the thermosensitive particles not only enhances the functional complexity of the staged dissociation zone, but also enables the gel to have structure tracing ability after behavior detection, establishing a quantifiable and observable corresponding relationship between the structure response path and behavior performance in the whole swallowing process.

[0031] To realize the behavior identification of the induction of swallowing initiation delay and the trend of swallowing ability attenuation, a delay adhesion area with controllable dynamic adhesion is arranged in the gel structure, which is prepared by using a low-strength bioreversible adhesion material, such as edible polysaccharide-protein complex, weakly polar polymer segment or microcapsule-encapsulated cross-linked colloid, and the adhesion performance thereof is activated at an oral temperature environment (about 35-37°C) to form a short-time adhesion state between the oral epithelium or the tongue surface, which can produce a time difference between the perceived delay and the swallowing preparation action before the individual swallows, and the adhesion state has a destructible property, which can be broken down, surface lubricated or adhesion force reduced in a very short time when subjected to mechanical pushing (such as light pressure, lifting or rotating) of the tongue or intervention of exogenous liquid (such as saliva increase or water flushing), so as to instantaneously release the adhesion state and induce the individual to make a voluntary swallowing action, which helps to test the active swallowing ability trigger threshold of the test subject in a non-reflex state; in addition, to identify the change trend of the swallowing function in the continuous use process, the gel structure is further configured to be continuously applied for multiple times, that is, different batches or different gradient levels of gels can be sequentially or cyclically swallowed by the individual, and after each use, the system records the adhesion response time, dissociation time, residual amount and behavior trigger delay of the gel in the oral cavity or pharyngeal cavity of the individual, and establishes the corresponding quantitative trend, especially in multiple continuous tests, if the adhesion release delay becomes longer, the swallowing trigger is delayed, the disintegration is incomplete or the pharyngeal cavity residue increases, it can be determined that the individual has a short-time fatigue of the swallowing muscle group, a decrease in the nerve conduction regulation ability or a decreasing trend of the behavior coordination function, which is defined as the fatigue window or the function decreasing window of the swallowing action, and through this method, structured, physiological and repeatable behavior data support can be provided for early screening of swallowing disorders, determination of fatigue limit or development of swallowing rehabilitation training cycle, so as to realize the longitudinal tracking and function fluctuation identification of dynamic monitoring of swallowing ability.

[0032] Combined with the drawings Figure 3To realize the quantitative evaluation of the clearance efficiency after the completion of swallowing action, the main body material with controllable disintegration structure is designed in the dissolvable food gel, and the marker responsive particles are embedded in it. The main structure is composed of thermo-sensitive or shear-sensitive hydrogel with adjustable crosslinking density, which can disintegrate under the combined action of body temperature, muscle compression force or liquid disturbance in the pharynx. The marker responsive particles are embedded in the disintegration structure and released into the pharyngeal cavity surface or cavity during the disintegration process. The size of the particles is in the range of 10-50 microns, and the edible visual tracking units such as thermo-sensitive color-changing particles, fluorescent response particles or dye microspheres with stable diffusion after coating are selected. The particles have the characteristics of controllable retention in a short time in the physiological environment and do not trigger reflex stimulation. A predefined observation time window is set in the system, which is counted from the completion of individual swallowing action and lasts to the set delayed detection endpoint, such as 30 seconds, 60 seconds or 90 seconds. During this period, the spatial distribution and behavior state of the above-mentioned marker responsive particles are recorded and identified by non-invasive monitoring means, including optical visual imaging, fluorescence detection, infrared absorption scanning or color change tracking technology assisted by augmented reality. If the particles show downward migration, diffusion, ablation or complete disappearance within the time window, it indicates that the pharynx has good natural clearance efficiency, which can actively complete the residual material clearance process after swallowing through the mechanism of mucociliary, pharyngeal peristalsis or residual force propulsion, etc. Otherwise, if the particles remain in place, do not change position obviously or form a retention area, it indicates that the pharynx has a certain degree of clearance disorder, which is related to insufficient pharyngeal muscle contraction, local weakness, mucosal response delay or coordination defects. The above migration behavior parameters can be further quantified as migration rate, clearance rate, reaction delay time and other indicators, which are combined with different gradient gel test results for superimposed analysis to form a comprehensive judgment of the integrity and efficiency level of the post-swallowing clearance function, providing structured support for the identification of swallowing disorders, verification of rehabilitation intervention effect and risk assessment of pharyngeal residual clearance.

[0033] To realize the fine identification of the pharyngeal clearance ability after the completion of swallowing action, especially to extract quantifiable features in the micro-disturbance response under non-swallowing conditions, a kind of marker responsive particle with sensing function is designed, which is embedded in a specific region structure of dissolvable food gel and enters the pharynx and stays for a short time during swallowing. The body is composed of a hydrophilic polymer base, and the response layer has fluid-sensitive properties, so that it has the ability to migrate after sensing local liquid disturbance or low-amplitude muscle activity. This migration behavior can be activated without forced swallowing action, so it can magnify the potential muscle peristalsis, mucociliary transport or liquid flow stimulation in the non-swallowing clearance path, thereby serving as an amplification signal for evaluating the natural clearance ability after swallowing. To capture the time characteristics of such dynamic response behavior, the system sets an observation time window , and divided into multiple sub-observation stages, such as , the spatial position of the particles is recorded in each stage to form a time-series displacement trajectory, and the existence of a decreasing trend in the clearance efficiency of the pharyngeal cavity or a functional delay performance is determined by analyzing the change rate of the particle position between stages, the residence duration, and the response initiation delay; in order to quantify the above behavior parameters and have continuous indicators, a time segmentation migration function modeling method based on dynamic disturbance response is proposed, in which the spatial migration response of the particles is represented as a first-order disturbance integral function , which is defined as follows: , wherein is the current observation time point for analysis; represents the local disturbance amplitude experienced by the pharyngeal mucosa surface per unit time, which is derived from the post-pharyngeal airflow, respiratory vibration, and residual muscle movement during clearing the throat, etc.; is a liquid flow disturbance function, which represents the micro-flow intensity formed in the pharynx by natural saliva secretion or water intervention after swallowing; is a low-amplitude pharyngeal muscle coordination coefficient, which reflects the degree of cooperation of the autonomic muscle group in the migration process; is the measured spatial displacement value of the marker particles per unit time, with a unit of microns / second, which is used to represent the actual amount of migration response; is the total disturbance response function value of the particles before time point, which characterizes the dynamic behavior potential of the particles in the current observation period; the system further sets a behavior response threshold function , if , it is determined that the subject has an effective non-swallowing clearance response in the observation period, i.e., the particles can produce obvious migration behavior under micro-disturbance, which indicates that the pharyngeal residual clearance pathway function is complete; if , it indicates that the clearance reaction is insufficient, and there are functional disorders such as low sensitivity of pharyngeal movement, limited muscle movement, or mucosal transport delay; the model provides a non-invasive, high-sensitivity quantitative method for early identification of mild dysphagia, differentiation of pharyngeal clearance capacity level, and dynamic tracking of swallowing recovery process based on the coupling dynamic modeling of the particle sensing displacement and background physiological disturbance.

[0034] ​To realize the identification and functional judgment of the individual's post-swallowing auxiliary clearance ability, a dynamic monitoring mechanism based on time window control and behavior induction response is designed. By setting a soluble gel structure containing marker response particles in structure, the particles are released into the pharyngeal cavity with the disintegration of the gel after swallowing, and the migration behavior of the particles is continuously tracked and recorded within the set time window, which is generally set to a 30 to 90 second delay monitoring segment. During this period, the natural migration, dispersion or retention of the particles in the pharyngeal cavity is observed through non-invasive detection methods. If the particles show significant migration behavior within the time window, it can be directly determined that the individual has good post-swallowing clearance ability. After the time window ends, if the particles still exist in a stable retention state, the individual is further guided to perform a standardized non-swallowing action, which includes but is not limited to light cough, clearing the throat, making a sound, nasal air jet or low-intensity pharyngeal muscle contraction. The purpose of this action is to activate the muscles and air flow channels of the pharynx or the oral-pharyngeal junction to produce certain clearance disturbance without triggering the formal swallowing reflex, so as to verify whether the individual has the starting non-swallowing auxiliary clearance mechanism. Before and after the behavior is completed, the system compares the distribution position, density image or visual signal of the marker response particles in the pharyngeal cavity again. If the particles appear displacement, dispersion, clearance or detachment from the mucosal surface into the hypopharynx or pharyngeal wall after the non-swallowing action, it indicates that the action effectively activates the auxiliary clearance pathway, and it can be judged that the individual has potential pharyngeal compensation ability. On the contrary, if the particles show no significant migration change after the non-swallowing action, it indicates that the individual's clearance mechanism mainly depends on active swallowing, and the pharynx has insufficient function in the auxiliary pathway at the current stage. This method can be used as an important technical means to distinguish different types of swallowing disorders (such as dynamic deficiency and reflex disorder) and to effectively evaluate the effectiveness of compensation pathway training, with the advantages of non-invasiveness, clear behavior guidance, objective and quantifiable response signal, which can provide structural support for rehabilitation training path design, patient classification management and treatment strategy decision-making.

[0035] To achieve exclusive detection of non-swallowing clearance behavior and enhance the recognition accuracy of the late-stage swallowing function path, a labeled response particle structure with a delayed release mechanism is designed. The particle is not directly exposed to the gel matrix, but is released in a controlled manner by coating a layer of delayed release shell. The shell is made of edible, temperature-responsive or shear-sensitive materials, such as low-crosslinking degree gelatin microfilm, amphiphilic chitosan coating, or degradable shell system based on liposome wrapping. During the swallowing process, the shell can withstand the temporary action of the shear force of the pharyngeal cavity and the main flow force of swallowing to remain intact, so that the particle is not directly discharged or enters the digestive tract with the main gel group in the swallowing action, but gradually breaks or structure unpacks under the influence of body temperature stimulation, saliva penetration or local enzymatic reaction in the pharyngeal cavity after a delay of 10-30 seconds after the individual completes the swallowing behavior. The particle is released from the shell to the surface of the pharyngeal cavity or the local fold area. This delayed release feature is significantly different from the synchronous release strategy of the general swallowing fluid path driven by instantaneous, ensuring that the particle can intervene and stay in the pharyngeal cavity environment after the completion of swallowing in the resting phase, thereby entering the non-swallowing clearance stage. Subsequent observation of its migration response through perturbation behavior induction (such as light cough, clearing the throat, and voice, etc.) is observed. The labeled response particle can use fluorescent dye microspheres, color-changing nanoparticles or optical reflection-enhanced particles, and its spatial distribution change is detected by external imaging equipment after release, so as to obtain whether the individual has spontaneous muscle movement, pharyngeal cavity cilia transport or airflow induction reaction and other functional performance under the non-swallowing clearance mechanism. This design physically separates the main clearance behavior and auxiliary clearance behavior in the swallowing process in time, and ensures that the particle remains in the detection area after the end of the main channel flow behavior through the setting of the delayed release structure, improving the behavior recognition specificity of the non-swallowing clearance path and the behavior relevance of the particle signal.

[0036] To further refine the spatial distribution of the residual clearance ability in different pharyngeal cavity regions after swallowing, a labeled response particle system with a grouping disintegration threshold control mechanism is designed. The particles are embedded in the food gel structure according to the preset strategy, each group of particles is coated with different types or thicknesses of delayed disintegration materials, which exhibit differential release or disintegration in the pharyngeal cavity environment according to local temperature, humidity, enzymatic reaction or pressure changes. The first group of particles has the lowest disintegration threshold, which is suitable for the first release and mainly locates in the upper pharynx region in the early stage of swallowing; the second group of particles has a medium disintegration response threshold, which is released at the time when the gel advances to the middle pharynx region; the third group of particles adopts a high threshold disintegration structure, which can be broken down only under the action of higher temperature or stronger mechanical disturbance, so it is mainly released or disintegrated in the lower pharynx region and stays in this part. The release and positioning sequence of the three groups of particles is realized by fine control of the thickness, cross-linking density, proportion of hydrophobic components or multi-layer coating sequence of the particle shell, so as to ensure that they are activated in sequence and distributed in different dissociation points of the pharynx according to the space-time logic in the swallowing process. Within the observation time window, the system dynamically monitors the distribution of the above three groups of particles in the upper, middle and lower pharynx regions through non-invasive imaging or signal recognition technology, identifies whether there are particle retention, migration delay or aggregation abnormalities in each region, and then analyzes whether the clearance ability of each functional region is balanced. If the upper pharynx particles migrate rapidly and the lower pharynx particles stay obviously, it indicates that the deep pharyngeal cavity muscle coordination or antiperistalsis function is insufficient. This grouping response strategy not only improves the resolution and accuracy of residual detection after swallowing, but also establishes independent clearance efficiency evaluation channels in different physiological regions, providing a basis for refined swallowing disorder diagnosis, regional functional training intervention and lesion positioning.

[0037] To improve the fine-grained recognition ability of the post-swallowing pharyngeal cavity clearance function, especially for the objective evaluation of the auxiliary clearance passage response level under the participation of micro-amplitude muscle movement, the test individual is guided to perform a set of non-swallowing, low-intensity, and self-controlled standardized actions within a set observation time window, which includes low-frequency sound, nasal air puff, and breath vibration. The low-frequency sound can be continuous "hum" sound or whistling sound, the nasal air puff is short and brief exhalation through the nasal cavity after closing the mouth, and the breath vibration is a glottal vibration behavior without voice. Such actions will not trigger a complete swallowing reflex, but can activate the local muscle coordination of the subglottic structure, soft palate, pharyngeal constrictor muscle, and nasopharyngeal oropharyngeal junction area, and disturb the ventilation path, so as to produce micro-amplitude fluid disturbance and muscle tension fluctuation in the pharyngeal cavity. In this process, the system detects the response behavior of the marker response particles that are retained in the pharyngeal cavity after swallowing through non-invasive observation means. Such particles are released on the surface or folded area of the pharyngeal cavity after swallowing, and have visual, fluorescent, or reflective characteristics, and can be displaced, diffused, or detached from the original position under micro-flow disturbance. If the particles show obvious migration or dispersion behavior before and after the execution of micro-movement, it indicates that the pharyngeal cavity has good clearance response to micro-amplitude muscle movement, and it suggests that the mucociliary, pharyngeal muscle contraction, and air flushing passage have functional response ability. On the contrary, if the particle position shows no significant change or is in a state of adhesion, it indicates that the individual has insufficient participation of pharyngeal muscle movement, low sensitivity of local power, or limited auxiliary clearance mechanism in the non-swallowing state. Such results are of great significance for judging the post-swallowing compensation mechanism, the adaptability of rehabilitation intervention strategy, and the airway protection ability. This method couples the behavior guidance, structure response, and observation index, and realizes the quantitative recognition of micro-response clearance ability under non-invasive conditions, effectively making up for the monitoring blind area of traditional swallowing evaluation in low-intensity muscle movement performance.

[0038] Example 1: In combination with the accompanying Figure 4In this embodiment, a 65-year-old female mild stroke rehabilitation patient Zhang, carries out swallowing behavior assessment experiment, the food gel used is a three-layer composite microstructure gel, the outer layer is a delayed adhesion zone, the material is acetylated gelatin and carboxymethyl chitosan compound, the surface adhesion modulus is controlled to be 3.2 kPa, so that it can form a mild adhesion on the tongue surface for 1.5-2 seconds at an oral temperature of 35-37°C; the middle layer is a gradient interface layer, which is a gelatin / sodium alginate mixture controlled by crosslinking density gradient, which starts to soften in the oral fluid after about 3 seconds of delay; the inner layer is a phased dissociation zone, which is a 30% mass ratio of polyvinyl alcohol / β-glycerophosphate composite heat-sensitive gel, which disintegrates within 5 seconds after exceeding 36.5°C and under shear force (about 100 Pa simulating pharyngeal contraction force) to release neutral fluorescent marker particles for subsequent clearance path tracking; in the experiment, Zhang swallows the gel once with the swallowing behavior simulation platform, and before swallowing, the delay time between the gel entering the oral cavity and the initiation of voluntary swallowing action is recorded as 2.8 seconds, indicating that the delayed adhesion zone effectively triggers the swallowing perception threshold; after entering the pharynx, the inner layer disintegrates completely within about 6 seconds, and there is no jamming reaction in the pharyngeal cavity, and more than 80% of the fluorescent particles are naturally cleared within 30 seconds after swallowing, only a small amount of particles are aggregated on the hypopharyngeal folds; in the repeated 3 experiments, it is found that the delay time is 2.8 seconds after the first swallowing, 3.6 seconds after the second swallowing, and 4.4 seconds after the third swallowing, showing an upward trend in the delay time of swallowing reflex, indicating that the patient has mild signs of swallowing fatigue; further, after the third swallowing, guide her to perform a light cough action, and then observe the clearance state of the fluorescent particles, and find that the clearance rate increases from 68% to 91%, indicating that she has certain auxiliary clearance path compensation ability; in addition, it can be seen from the image recognition record that the muscle group resets about 1.2 seconds after the third swallowing, and a slight repeated swallowing action occurs, which proves that the phased dissociation zone has good pressure-bearing effect on the hypopharyngeal pushing behavior, but is limited by the decline of the patient's pharyngeal muscle fatigue coordination ability, causing the clearance to be relatively delayed; through the mapping of the functional distribution of the layer-by-layer microstructure and the dynamic physiological response, this example successfully separates and quantifies the independent characteristics of the three stages of pre-swallowing perception initiation, mid-swallowing propulsion, and post-swallowing residue clearance, making the assessment process independent of subjective scoring and realizing material-dominated objective behavior capture, establishing a complete and feasible technical path for clinical swallowing function assessment, rehabilitation efficacy verification, and behavior monitoring.

[0039] On the basis of the results of the previous stage experiment, in order to further identify the hidden fatigue trend and remove the ability fluctuation of Zhang's swallowing function, the experimental team conducted a second stage of dynamic swallowing assessment test on him, using an upgraded version of the soluble food gel gradient structure. The key new design is to embed a gradual interface layer between the delayed adhesion zone and the phased disintegration zone. The layer is made of gelatin-sodium alginate composite material with increasing concentration, and its crosslinking degree gradually changes from 0.05 mol / g to 0.12 mol / g from the surface to the inner layer. The interface layer is 1.5 mm thick and gradually softens within 3-5 seconds after saliva penetration, forming a response transition from stable adhesion to disintegrable structure, ensuring that the gel does not immediately disintegrate in the mouth due to surface movement, and avoiding structural mutations that cause irritation after entering the pharynx; At the same time, two types of tracer materials, thermosensitive color-changing particles and edible fluorescent marker particles, are uniformly dispersed in the phased disintegration zone. The thermosensitive particles are warm dye-coated gelatin microspheres (particle size about 25 μm), which change from blue to white above 36.5°C, and can be used to track the release area of the particles through endoscopic visualization; The fluorescent particles are made of edible red fluorescent sodium particles (concentration 0.02% w / w), which can be captured by external imaging instruments under low-intensity excitation light after release; Zhang completed 5 consecutive swallows, with a 90-second interval between each round, and ingested the same amount of three-layer structure gel (about 7g) in each round. The system recorded his delayed start time (i.e. the time from the loss of adhesion of the delayed adhesion layer to the start of swallowing), particle residual rate, 30-second clearance efficiency after swallowing, and the visible residual area of thermosensitive particles in the hypopharynx.

[0040] In the first round, the delay time was 2.7 seconds, the 30-second fluorescent residual particle clearance rate was 89%, and the thermosensitive color-changing particles were mainly distributed in the middle pharynx. The color change to white indicated that the temperature trigger was sufficient, indicating that the structure had successfully disintegrated, with a residual area of about ; In the second round, the delay time increased to 3.3 seconds, and the clearance rate decreased to 83%, with the residual area expanding to ; In the third round, Zhang began to show signs of micro-fatigue, such as slightly opening his mouth and lengthening the time for the pharyngeal muscles to reset. The delay time further increased to 4.1 seconds, the particle clearance rate decreased to 75%, and the thermosensitive color-changing area increased, with some particles not changing color, indicating a delay in the phased disintegration response; In the fourth round, the delay time decreased to 3.2 seconds after the introduction of 5mL warm water stimulation intervention, but the particle clearance rate did not significantly recover, indicating that the fatigue bottleneck existed in the pharyngeal muscle auxiliary ability; In the fifth round, the delay time was 4.9 seconds without any stimulation, and the clearance rate was as low as 61%, with a large area of particle aggregation on the posterior pharyngeal wall, about The discolored residue area did not migrate, which corroborates that the swallowing action loop has been significantly loosened and the residue clearance mechanism has been significantly weakened. In addition, the adhesion area can achieve an average of 1.2 seconds of de-adhesion response with light pressure of the tongue tip in each round of testing, indicating that the structure is well controllable, but the initiation action shows a clear trend of fatigue in the initiation intention.

[0041] Based on the above data analysis, during continuous swallowing, Zhang's average adhesion delay time increased from 2.7 seconds in the first round to 4.9 seconds in the fifth round, the particle clearance rate decreased from 89% to 61%, and the thermosensitive color-changing residual area increased from 0.4 cm² to 1.2 cm². These three indicators simultaneously point to a phased decreasing trend in swallowing efficiency and clearance capacity. The transitional effect of the gradient interface layer ensures a smooth structural change process and avoids interruption of the action. The distribution feedback of thermosensitive and fluorescent dual-labeled particles provides a clear spatial location and action behavior mapping path. This continuous experimental model clearly captured the fatigue window period that Zhang experienced after 3 to 4 consecutive swallows. It not only verified the response logic of each layer of the gel structure, but also provided a concrete material basis and behavioral data support for the early identification of swallowing disorders, the formulation of training plan frequency, and the assessment of individual rehabilitation progress.

[0042] Example 2: Combined with appendix Figure 5 Based on Example 1, after completing five rounds of continuous swallowing dynamic fatigue testing on Mr. Zhang, the experimental team designed and implemented an independent functional tracking test targeting post-swallowing clearance efficiency. The food gel structure used, based on the delayed adhesion zone and the staged dissociation zone, enhanced the design of a controllable disintegration structure and introduced embedded labeled responsive particles to achieve post-swallowing behavior tracking and evaluation. The main material of this structure is a composite thermosensitive hydrogel (30% gelatin + 3% sodium alginate), whose embedded particles consist of edible microspheres loaded with sodium fluorescein, with a particle size controlled at 20–30 μm, embedded in high-density cross-linked microcapsules, which can be released within 5–8 seconds as the gel structure disintegrates at 37°C. Before the test, Mr. Zhang was guided to complete a single standard swallowing action through a training platform. The system determined the completion point of the swallowing action (defined as...) using a submental acoustic sensor and larynx displacement. ), and from The observation time window begins at any moment. The total duration was set to 90 seconds, and the window was divided into three phases: 0–30s, 31–60s, and 61–90s. A non-invasive fluorescence imaging module, in conjunction with a reflector, was used in the anterior neck region to monitor the migration trajectory and residual distribution of fluorescent particles in the pharynx.

[0043] In the first stage (0–30s), after the particles began to be released, more than 80% were distributed on the posterior pharyngeal wall and the upper part of the piriform fossa. Mr. Zhang did not exhibit any obvious throat clearing or coughing behavior, and the particle position changed very little. The system recorded the initial residual particle intensity as [value missing]. (normalized value); to the second stage (31-60 s), due to the slow diffusion of the particles caused by the peristalsis of the pharynx and the disturbance of saliva, the system monitors the fluorescence intensity to , the average displacement radius is 4.1 mm, indicating that there is a certain natural clearance capacity; to the third stage (61-90 s), the particles further migrate and disperse, but 34% of the particles remain concentrated under the root of the tongue and the posterior wall of the pharynx, which is a typical post-swallowing retention prone site, and the normalized intensity value at the end of 90 seconds is , the system determines that the natural clearance efficiency is medium to low according to the residual migration rate To verify whether the particle migration is caused by the clearance reaction, the experimental team retests the control group of two healthy volunteers (male 45 years old, female 50 years old) under the same conditions, and the average particle intensity decreases from to , the migration rate is about 72%, and the average displacement radius is as high as 9.2 mm, confirming that Zhang's pharyngeal cavity has a significant deficiency in late clearance capacity.

[0044] After confirming that there is a certain decay trend in Zhang's post-swallowing natural clearance capacity, the experimental team further introduces inductive marker response particles for post-swallowing non-swallowing clearance pathway function identification to capture the micro-response behavior of the particles to the intrinsic muscle movement and liquid disturbance in the pharynx and perform dynamic modeling analysis. In this experiment, the marker response particles used are fluorescent nanoparticles coated with a mucosa shear sensitive layer, with a particle size controlled at 18-25 μm, a shell layer of modified gelatin-polylactide composite structure, with a certain flexibility and disturbance migration sensitivity, and a particle density controlled at 1 , which will not quickly settle due to gravity, and is sufficient to produce a small displacement under microfluidic traction. After swallowing is completed, the system sets a total observation time window , and divides it into three sub-intervals: . In each stage, the particle signal trajectory in Zhang's pharyngeal cavity area is collected by a non-invasive neck fluorescence image acquisition instrument, and a first-order disturbance integral function model is introduced to calculate the dynamic response potential , the specific modeling is as follows: In this example, the function variable value range is defined as follows: the disturbance amplitude function reflects the natural vibration and neural micro-response intensity of Zhang's pharynx in the non-swallowing resting period, which is in the range of (normalized) after calibration by a sound wave microsensor; the liquid disturbance function represents the natural diffusion intensity of saliva in the pharynx after secretion, which is derived from the local humidity meter and has a value in the range of (unit: μL / s); the coordination rate function The micro-muscle group autonomous contraction coordination of Zhang in a quiet state is calculated by the micro-module of the electromyography monitoring to be 0. 15 (unit normalization); particle displacement function The average measurement of the particle trajectory tracking by the imaging system is 0. 15 mm / s.

[0045] According to the actual detection, the following typical data segments are obtained under the condition of 1 Hz sampling frequency in the interval of 0-30 seconds after Zhang completes swallowing: ; ; ; mm / s; The calculation is as follows: Similarly, during the second stage (31-60s), decreases to 0. 06, slightly increases to 0. 41, decreases to 0. 19, decreases to 0. 025 mm / s, and the calculation is as follows: In the third stage (61-90s), decreases to 0. 12, decreases to 0. 016 mm / s, indicating that muscle fatigue begins to appear: The system sets the threshold function for Zhang (deduced according to the average value of the healthy group for 90s), so the result is judged as follows: , indicating that its non-swallowing clearance response ability in the current test is lower than the normal reference range, and muscle response attenuation appears after 60 seconds. Combined with the previous residual particle image distribution analysis, it is confirmed that there is a delay trend and local power disorder in the pharyngeal cavity self-clearance ability.

[0046] After the aforementioned Zhang's post-swallowing natural clearance ability was quantified as below the healthy threshold, the experiment further designed a set of verification behavior detection tasks to determine whether it has an activated auxiliary clearance mechanism, and combined with the delayed release marker response particles and grouping particle positioning design, completed the test and analysis of the activation ability of non-swallowing channels in the post-swallowing period. In order to avoid the particles being directly taken out in the main swallowing action, the experimental team used a double-layer coating strategy to prepare the response particles, the outer layer of the particles was a pyrolytic delayed shell layer (gelatin + low cross-linking degree gelatin aldehyde composite material), the thickness was set to 20-25 pm, and the experiment proved that it needed about 40±5 seconds to occur structure unpacking at 37°C environment, and release the wrapped fluorescent tracking particles. The inside of the particle was further divided into three groups according to the different environmental stimuli required for unpacking: low threshold group (group A, upper pharynx positioning, shell layer containing pH sensitive fragments, easy to release in response to saliva stimulation), medium threshold group (group B, middle pharynx positioning, responding to pyrolysis), high threshold group (group C, lower pharynx positioning, needs mild shear force to release), the particle size is uniformly controlled at 20 pm, and contains red, green and blue three different wavelengths of fluorescent dyes for partition identification.

[0047] After Zhang ingested the structured composite gel, completed the standard swallowing action, the system set double recognition of laryngeal prominence movement and submental sound wave , from Start entering the total observation time window . In this stage, the system records the release time, spatial diffusion trajectory and intensity distribution of the three groups of particles in different regions through non-invasive fluorescence imaging device: group A particles are released within 15-25 seconds, concentrated in the posterior wall of the soft palate and the upper pharyngeal vault area, group B particles are released within 35-45 seconds, positioned in the central part of the pharynx and the posterior groove of the epiglottis, and group C releases lag to 60-75 seconds, mainly gathered in the piriform fossa and the lower pharynx entrance area. According to the signal intensity decay curve of each group of particles, the overall residual rate is still 68% before , among which the residual of group C is the most obvious.

[0048] Subsequently, the system guides Zhang to perform a round of non-swallowing action activation task, the task includes: ①uttering the command "hmm-" for 3 seconds (low frequency glottis vibration), ②shortly exhaling 3 times through the nose with the mouth closed (nasal air puff), ③uttering a slight cough sound with the lips closed (breath vibration), the total duration of the behavior is about 15 seconds, and there is no discomfort feedback. The system continues to collect T 90 + T 105 stage fluorescence image, compare the spatial distribution changes of particles before and after: Group A (upper pharynx) residual particles decreased by 42%, the average displacement radius increased by 5.1 mm; Group B (middle pharynx) particle migration rate reached 39%, and part of the particles dispersed to the base of the tongue or the posterior pharyngeal wall; Group C (hypopharynx) particles were reduced by only 21%, and were strongly aggregated, some of which were still attached to the piriform fossa area.

[0049] Substitute the intensity change before and after each group into the clearance response ratio model: Wherein: Group A: ; Group B: ; Group C: ; The results show that Zhang has good auxiliary action clearance response ability in the upper and middle pharynx regions, but there is obvious functional response lag or local clearance disorder in the lower pharynx region. The observation structure controls the release by delaying and responds to the particle partition, so that the clearance behavior signal is significantly amplified after the non-swallowing action occurs, effectively capturing the micro-clearance ability difference of different anatomical regions of the pharynx cavity, indicating that Zhang has certain startable clearance compensation mechanism, and it is suggested that the rehabilitation path can focus on lower pharynx muscle training and simulated breath stimulation intervention.

[0050] The above shows and describes the basic principles, main features and advantages of the present application. Those skilled in the art should understand that the present application is not limited to the above examples, and the above examples and descriptions in the specification are only to illustrate the principles of the present application. Without departing from the spirit and scope of the present application, various changes and improvements can be made to the present application, and these changes and improvements all fall within the scope of the present application. The scope of protection of the present application is defined by the appended claims and their equivalents.

Claims

1. A method for dynamic quantification of swallowing ability based on a dissolvable food gel gradient, characterized in that The application relates to a food gel for swallowing function test, which comprises the following steps: A microstructure unit composed of a transient surface adhesion area and a medium-term loose layer is constructed in a dissolvable food gel to simulate the initial perception delay and medium-term release response in the swallowing process; by regulating the hydration diffusion rate, surface tension and internal cohesive force difference of the gel, different material behavior responses are generated in the pre-swallowing, mid-swallowing and post-swallowing stages, each stage of the gel corresponds to a set micro-viscosity and release coupling ratio, so that the swallowing strategies in different stages are adapted; When an individual swallows the gel, the time delay from the gel retention to the occurrence of the swallowing action is collected, and the delay is controlled by the design of the micro-adhesion structure; and a non-invasive monitoring method including a mandibular action sensor, a laryngeal position sensor or an acoustic reflection analysis is used to record the starting time point of the swallowing action in real time; Part of the food gel is embedded with controllable disintegration temperature-sensitive micro-particles or traceable micro-capsules, the micro-particles are retained in the pharyngeal cavity after swallowing, the clearance efficiency after swallowing is detected according to the migration behavior within a set time window, and whether the residual can be removed through non-swallowing action such as coughing or clearing the throat is observed; After swallowing, the reset behavior of the oral cavity, tongue and pharyngeal muscle group is monitored by using a non-contact action capture device including acoustic analysis, vibration monitoring or image recognition; when reset delay, secondary mouth opening, swallowing repetition or pharyngeal itching characteristic action occurs, it is judged that the swallowing behavior closed loop is interrupted, so as to comprehensively evaluate the swallowing function integrity and dynamic ability state of the individual.

2. The method for dynamic quantification of the swallowing ability based on a soluble food gel gradient according to claim 1, characterized in that The food gel is composed of a multi-layer microstructure, including a delayed adhesion area arranged on the outer layer and a stage dissociation area arranged on the inner layer; the delayed adhesion area is composed of a material with short-time biological adhesion performance, forms a transient adhesion state in the oral cavity, and delays the perception of swallowing trigger; The stage dissociation area has temperature responsiveness and structure disintegrability, and is configured to realize controllable structure disintegration after the gel enters the pharynx, promote the gel to advance and be easily removed after swallowing; the food gel structure adjusts the local thermal responsiveness of the multi-phase hydrogel matrix and controls the spatial distribution characteristics, So as to form three types of material response behaviors of perception start, channel crossing and residual removal in the pre-swallowing, mid-swallowing and post-swallowing stages respectively.

3. The method for dynamic quantification of the swallowing ability based on a soluble food gel gradient according to claim 2, characterized in that A gradient interface layer is arranged between the delayed adhesion area and the stage dissociation area, and the gradient interface layer exhibits time-delayed interface dissolution behavior after saliva contact, which is used to adjust the transition rate of the structure response between the two areas; The stage dissociation area is dispersed with heat-sensitive color-changing micro-particles or edible fluorescent marker particles, which can be used to track whether the gel is completely removed after swallowing, so as to assist in evaluating the residual behavior in the pharynx.

4. The method for dynamic quantification of the swallowing ability based on a soluble food gel gradient according to claim 3, characterized in that The delayed adhesion area forms an adhesion state at the temperature of the oral cavity, but can lose adhesion instantaneously under the action of the tongue or liquid intervention, so as to induce the self-swallowing reaction of the subject after the perception delay; the gel structure is configured to be continuously applied for multiple times, and presents a quantity variation trend of adhesion response or disintegration response after each use, which is used to identify the swallowing action fatigue window or function degradation performance of the individual through multiple swallowing tests.

5. The method for dynamic quantification of the swallowing ability based on a soluble food gel gradient according to claim 1, characterized in that The food gel comprises a main body with controllable disintegration structure and embedded marker-responsive particles; the marker-responsive particles are released after the individual completes the swallowing action and are retained in the pharyngeal cavity; the system is provided with an observation time window, which indicates a time period from the completion of swallowing to a predetermined delayed detection endpoint, and the migration or residual behavior of the marker-responsive particles is detected in the time window by a non-invasive method for evaluating the natural clearance efficiency of the pharyngeal cavity after swallowing.

6. The method for dynamic quantification of the swallowing ability based on a soluble food gel gradient according to claim 5, characterized in that The marker-responsive particles have self-migration ability after sensing the disturbance of mucosal fluid, and the marker-responsive particles exhibit traceable displacement behavior under the influence of trace liquid flow or pharyngeal cavity spontaneous muscle movement, for amplifying the response signal of the clearance action; the time window is divided into multiple observation stages, the position change of the marker-responsive particles is recorded in different stages, and according to the time delay or response speed of particle migration, it is judged whether there is a decay or delay trend of pharyngeal cavity clearance efficiency.

7. The method for dynamic quantification of the swallowing ability based on a soluble food gel gradient according to claim 6, characterized in that After the end of the time window, the individual is guided to perform a non-swallowing action, and by comparing the spatial distribution change of the marker-responsive particles before and after the non-swallowing action, it is judged whether the individual has an available auxiliary clearance mechanism.

8. The method for dynamic quantification of the swallowing ability based on a soluble food gel gradient according to claim 7, characterized in that The marker-responsive particles are coated in a delayed release shell, which breaks or unpacks after a period of time after the swallowing action ends, so that the particles are released with a lag and are not completely taken out along the main swallowing path, so that the particles enter the non-swallowing clearance stage for behavior detection.

9. The method for dynamic quantification of the swallowing ability based on a soluble food gel gradient according to claim 8, characterized in that The marker-responsive particles are provided with grouped particles with different disintegration thresholds, each group is positioned at a different disintegration point in the pharyngeal cavity, for identifying the residual migration trajectories of the upper pharynx, middle pharynx and lower pharynx regions in the observation time window, respectively.

10. The method for dynamic quantification of the swallowing ability based on a soluble food gel gradient according to claim 9, characterized in that The individual is guided to perform low-frequency vocalization, nasal air puffing or breath vibration in the observation time window, and the clearance responsiveness of the pharyngeal cavity to the micro-amplitude muscle movement is judged by detecting the response behavior of the particles.

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