A multi-modal anorectal detection endoscope probe and its application

Abstract

The present invention provides a multimodal anorectal detection endoscope probe and its application. The probe has multimodal stimulation function characteristics and is composed of a rigid front end and a flexible rear end. The front end has functions such as image acquisition, pressure detection, and multimodal stimulation of the internal anal sphincter. The flexible rear end can be bent and is wrapped with an expandable balloon on the outside. It has the functions of intestinal cavity morphology, pressure, bending angle detection, and intestinal mechanical and temperature stimulation. The probe is designed and manufactured to simulate the real intestinal contents, and can perform multimodal stimulation on the rectum and the internal anal sphincter respectively, collect the pressure, stress-strain, cavity morphology, anal right angle, peristalsis and other physiological characteristic parameters of the anorectal response to various stimuli, and compare and analyze with the sphincter movement image to achieve the evaluation of sphincter movement and nerve reflex function. It can be used for anorectal disease diagnosis and drug pharmacology analysis.

Description

Technical Field

[0001] The invention relates to a multi-modal anorectal detection endoscope probe and application thereof, belonging to the technical field of medical equipment. Background Art

[0002] Gastrointestinal motility, anorectal sensation, rectal contraction, pelvic floor muscle coordination, intestinal cavity volume, etc. can directly cause functional disorders, causing the colon to transmit and discharge more slowly. For example, the reduced sense of colon filling leads to the contraction of fecal discharge function. This perceptual dysfunction is very common in patients with defecation disorder syndrome and is closely related to structural abnormalities such as megacolon; abnormal coordination of pelvic floor muscles causes functional defecation disorders, which are often manifested as pelvic floor muscle relaxation; biomechanical abnormalities caused by tissue deformities (such as intussusception, rectal prolapse, etc.) inhibit the normal excretion of feces. These pathogens can be divided into two categories: mechanical structural abnormalities and functional abnormalities. Mechanical structural abnormalities can be evaluated by rectal examination and medical imaging technology. Functional abnormalities require comprehensive analysis through a variety of methods that focus on the examination of tissue mechanical properties.

[0003] In the prior art, CN201580070098.0 discloses an electronic device that can be inserted into the rectum or colon, which can be used for biomechanical research on defecation function. It includes a flexible core made of solid or semi-solid material, which can be bent or compressed, and one or more sensors are arranged inside or on the surface. One of the sensors can detect the pressure of the device in the digestive tract or during expansion. In addition, a plurality of impedance measurement electrodes are arranged on the surface of the core to test the corresponding cross-sectional impedance of the device in the digestive tract or during expansion. The impedance data of the cross section can be used to calculate the cross-sectional area of ​​the application. It can be used for intestinal mechanical function detection during natural defecation. CN201720556352.4 discloses a high-frequency dynamic detection device for balloon morphology, comprising a detection probe and a detection circuit; the detection probe is a slender catheter on which N annular electrode sheets are arranged; the detection circuit comprises an MCU processor, the MCU processor generates a constant current square wave signal, and the signal is transmitted to the first and last two excitation electrodes of the detection probe at a certain frequency by an excitation signal converter; the output signal converter transmits the potential difference signal between adjacent electrodes in the signal acquisition circuit after signal uniformity processing to the pre-filter in sequence for filtering, differential amplification, low-pass filtering, and a high-precision A / D converter converts the analog signal into a digital signal and sends it to the MCU processor, and finally the MCU processor communicates with the host computer in serial port according to a fixed communication protocol; the detection circuit can complete the real-time detection of N? 1 balloon cross-sectional morphologies; it solves the problem of circuit miniaturization of the impedance measurement system in the probe system. CN202010479710.2 discloses a medical bionic detection probe and a preparation method thereof. The flexible core, balloon and perfusion catheter in the probe are reasonably designed, and multiple split functional modules are precisely positioned in the flexible core. The functional components are electrically connected by spiral cables, which extend from the rear end of the core and are connected to an external host computer through wires, effectively solving the problems of complex structure, single function, poor circuit stability and detection accuracy in the prior art.

[0004] However, the above technologies mainly focus on the detection of functional indicators in natural anorectal defecation, and are very lacking in neurological and imaging detection functions, making it difficult to meet the functional requirements of organic lesions and sensory function diagnosis. Summary of the invention

[0005] In view of the above-mentioned deficiencies in the prior art, the object of the present invention is to provide a multimodal anorectal detection endoscope probe to solve the deficiencies of the prior art in terms of lack of biochemical and imaging detection functions, so as to meet the functional requirements of organic lesions and sensory function diagnosis.

[0006] To achieve the above purpose, the present invention adopts the following technical means:

[0007] A multi-modal anorectal detection endoscope probe, characterized in that it is composed of a rigid front end and a flexible rear end, and the rigid front end and the flexible rear end are connected by fasteners;

[0008] The rigid front end is composed of a transparent shell and internal components; the internal components include a multi-lumen tube, a stimulation tube, an irrigation tube and a connector, and is also provided with a peepscope module, a front sensor module, an electrical stimulation electrode, an external multi-lumen tube and a data cable; wherein the peepscope module is used for image acquisition, the front sensor module is used for detecting the terminal rectal pressure, and the pressure measuring hole on the multi-lumen tube is used for detecting the anal canal pressure;

[0009] The flexible rear end is bendable, and the outside of the flexible rear end is wrapped with an expandable balloon, which contains a middle sensor module, a rear end sensor module and / or a bending sensor, and a plurality of test electrodes are distributed on the surface of the flexible rear end.

[0010] Furthermore, the front-end sensor module, the middle sensor module and the back-end sensor module respectively contain multiple sensors such as pressure, temperature, and posture and / or a single-chip microcomputer.

[0011] The multi-lumen tube has several lumens, wherein the first lumen is connected to the stimulation tube, the second lumen is connected to the perfusion tube, and the third or multiple lumens are provided with pressure measuring holes; the opening of the stimulation tube is located at the rounded chamfered edge in the outlet direction; the perfusion tube is used for balloon dilation; and the pressure measuring hole is used for anal canal pressure detection.

[0012] The inner diameter of the first cavity is greater than 0.3 mm; the inner diameter of the second cavity is greater than 0.8 mm, meeting the perfusion speed requirement of 80 ml / min; and the inner diameter of the third cavity is greater than 0.3 mm.

[0013] Furthermore, the multimodal stimulation function includes: the stimulation electric signal acts on the internal anal sphincter through the electric stimulation electrode to achieve electrical stimulation; the gas and / or liquid acts on the internal anal sphincter through the stimulation tube through its opening, and the physical and biochemical stimulation is achieved by adjusting the physical and biochemical characteristics and injection method of the gas and / or liquid; the expandable balloon is expanded by injecting ion solution in the rectum and sigmoid colon through the perfusion tube, and the intestine is mechanically and thermally stimulated by changing the temperature and volume of the injected solution.

[0014] Furthermore, the evaluation of anorectal sphincter movement and nerve reflex function includes that when the anorectum is subjected to different stimuli, the endoscope module will collect anal sphincter movement images, the front sensor module detects the terminal rectal pressure, the pressure measuring hole on the multi-lumen tube detects the anal canal pressure, the middle sensor module detects the intestinal pressure exerted on the expandable balloon, the rear sensor module detects the intestinal propulsion force exerted on the rear end of the probe, the posture sensor and / or bending sensor in the front sensor module and the rear sensor module detect the change of the anal right angle, and a number of test electrodes distributed on the flexible rear end surface detect the intestinal cavity morphology; the functional indicators such as pressure, morphology and angle are comprehensively analyzed with the movement images, so as to realize the evaluation of anorectal sphincter movement and nerve reflex function.

[0015] Furthermore, the sphincter movement collection and comparison method includes, firstly, identifying the folding line of the internal anal sphincter as a characteristic curve, and using the characteristics of anal levation and force expulsion as the movement boundary; then performing feature matching on each frame of the image, and performing block processing along the curve; after the block division is completed, drawing a curve of the change of block size over time, and a grayscale projection change curve of each edge curve; finally, reflecting physiological movement abnormalities such as sphincter spasm and tremor through the abnormal frequency of block size change and the curve movement characteristics.

[0016] The present invention also provides an application method of a multimodal anorectal detection endoscope probe, which is used for multimodal stimulation of the anorectal area. The stimulation electrical signal acts on the internal anal sphincter through the electrical stimulation electrode to complete the electrical stimulation; the gas and / or liquid acts on the internal anal sphincter through the stimulation tube through its opening, and the physical and biochemical stimulation is completed by adjusting the physical and biochemical characteristics and injection method of the gas and / or liquid; the expandable balloon is expanded by injecting ion solution into the rectum and sigmoid colon through the perfusion tube, and the intestine is mechanically and thermally stimulated by changing the temperature and volume of the injected solution.

[0017] Furthermore, the probe is used to evaluate the movement of the anorectal sphincter and the nerve reflex function; when the anorectum is subjected to different stimuli, the endoscope module will collect the movement image of the internal anal sphincter, the front sensor module detects the terminal rectal pressure, the pressure measuring hole on the multi-lumen tube detects the anal canal pressure, the middle sensor module detects the intestinal pressure exerted on the expandable balloon, the rear sensor module detects the intestinal propulsion force exerted on the rear end of the probe, the posture sensor and / or bending sensor in the front sensor module and the rear sensor module detects the change of the anal right angle, and a number of test electrodes distributed on the flexible rear end surface detect the intestinal cavity morphology; the functional indicators such as pressure, morphology and angle are comprehensively analyzed with the movement image, so as to realize the evaluation of the movement of the anorectal sphincter and the nerve reflex function.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] 1. The multimodal anorectal detection endoscope probe provided by the present invention is composed of a rigid front end and a flexible rear end; the rigid front end has functions such as image acquisition, pressure detection, and perfusion stimulation; the flexible rear end can be bent, and the outside is wrapped with an expandable balloon, and has impedance testing, pressure detection, bending angle detection, mechanical and temperature stimulation functions. The probe is designed and manufactured to simulate the real intestinal contents, and can perform multimodal stimulation on the anorectal tissue, and measure the anorectal multi-point pressure at the same time, including important physiological characteristics such as strain characteristics, anal right angle, and anal sphincter contraction images; different drug solutions can be injected through the stimulation tube, and the drug can directly stimulate the internal anal sphincter, so that the anorectal produces corresponding movements. For example, the excretion-promoting drug will make the internal sphincter more relaxed, and the pressure of the rectal terminal and anal canal pharmacology during simulated defecation movements is lower than when there is no drug stimulation. Other drugs used for anorectal treatment are similar, and the implementation method is to detect whether the anorectal response to the test drug is normal, or when the drug properties or physiological reactions are unknown, the anorectal nerve reflex characteristics caused by the drug are measured to achieve pharmacological analysis. It can be used for sphincter function evaluation, drug pharmacological analysis, etc. By collecting and comparing the anorectal mechanical function characteristics and sphincter movement characteristics under different physiological movements, mechanical, biochemical stimulation and electrical stimulation conditions, the diagnosis of anorectal sensory function and sphincter function can be achieved; and the sphincter folding line is used as the identification feature, and the physiological movements such as spasm and tremor of the internal anal sphincter are detected by image comparison, and the image is combined with biomechanical information to detect the correlation between anorectal organic lesions and functional lesions. By introducing multiple modal stimulation methods and motion image acquisition functions, the lack of effective neural and imaging function evaluation in the diagnosis of organic lesions and sensory functions of functional detection technology is supplemented.

[0020] 2. The multi-modal anorectal detection endoscope probe provided by the present invention is specially designed with fasteners. Multiple front-to-back through-channels can allow the colloid to flow into the groove on the rigid front-end shell during the injection molding process. After the colloid is solidified, it can be tightly connected with the flexible rear end as a whole to ensure the connection stability of the front and rear structures of the probe. It solves the problem of insufficient connectivity between the flexible rear end and the rigid front end due to silicone or other poor bonding properties, which is conducive to ensuring the structural stability of the probe, while avoiding secondary reinforcement and simplifying the processing process.

[0021] 3. With the assistance of the camera to collect images, the present invention can better locate tissue structures during the placement of the probe compared to existing functional probes. The probe can be placed at different distances from the anal canal, that is, in some views: the lower part of the rectum can be focused; it can also be placed at the puborectalis muscle to perform a large number of multimodal stimulation analysis and detection. At this time, any lateral movement of the probe captured by the camera can be used as an indicator of relaxation / contraction of the puborectalis muscle.

[0022] 4. The present invention also provides an application method of the multi-modal anorectal detection endoscope probe, which has the characteristics of convenient operation and complete functions. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a schematic diagram of the structure of the multi-modal anorectal detection endoscope probe of the present invention;

[0024] Figure 2 is Figure 1 A, B, and C are schematic diagrams of the rigid front-end structure, components, and fastener structures, respectively;

[0025] Figure 3 yes Figure 1 Schematic diagram of the structure of the multi-lumen tube;

[0026] Figure 4 is a schematic diagram of the insertion site in this specific embodiment;

[0027] Figure 5 is a schematic diagram of a multimodal stimulation method in this specific implementation mode;

[0028] Figure 6 is a flow chart for comparison and abnormal diagnosis of sphincter movements in this specific embodiment;

[0029] Figure 7 Schematic diagrams (A, B) of the identification and movement of the internal anal sphincter folding line in a specific implementation manner.

[0030] In the figure, 1-rigid front end, 2-flexible rear end, 3-scope module, 4-front end sensor module, 5-opening, 6-expandable balloon, 7-middle sensor module, 8-rear end sensor module, 9-bending sensor, 10-test electrode, 11-multi-lumen tube, 12-data cable, 13-pressure measuring hole, 15-transparent shell, 16-component, 17-electric stimulation electrode, 19-fastener; 23-stimulation tube, 24-perfusion tube;

[0031] 30-probe, 31-anal sphincter, 33-anal angle, 34-puborectalis muscle, 37-internal anal sphincter, 38-levator ani muscle, 39-external anal sphincter, 43-gas or liquid substance;

[0032] 51 - second cavity, 52 - first cavity, 53 - third or more cavities;

[0033] 85-approximate muscle fold line 1, 87-approximate muscle fold line 2, 93-drawing block 1, 94-drawing block 2. DETAILED DESCRIPTION

[0034] The present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0035] like Figure 1As shown, a multi-modal anorectal detection endoscope probe is composed of a rigid front end 1 and a flexible rear end 2; the rigid front end 1 and the flexible rear end 2 are connected by a fastener 19. The rigid front end 1 is provided with an endoscope module 3, a front sensor module 4, an opening 5, an electrical stimulation electrode 17, an external multi-lumen tube 11 and a data cable 12; wherein, the endoscope module 3 is used for image acquisition, the front sensor module 4 is used for detecting the pressure at the end of the rectum, the pressure measuring hole 13 on the multi-lumen tube 11 is used for detecting the anal canal pressure, and the front sensor module 4 is used for detecting the pressure on the front end of the probe.

[0036] The flexible rear end 2 is wrapped with an expandable balloon 6, which contains a middle sensor module 7 and a rear end sensor module 8, and / or a bending sensor 9, and has a plurality of test electrodes 10 distributed on the surface, which has the functions of impedance testing, pressure detection, bending angle detection, mechanical and temperature stimulation. The front end sensor module 4, the middle sensor module 7 and the rear end sensor module 8 each contain a variety of sensors such as pressure, temperature, and posture, and / or a single chip microcomputer.

[0037] The probe has multi-modal functional characteristics. The probe is designed and manufactured to simulate real intestinal contents, and can perform multi-modal stimulation on anorectal tissues, while measuring important physiological characteristics such as anorectal multi-point pressure, strain characteristics, anal right angle, and anal sphincter contraction images; it can be used for sphincter function evaluation, drug pharmacology analysis, etc.

[0038] Wherein, the flexible rear end is made of silicone, and the internal circuit is a split module structure. The circuit connection method refers to the "A medical bionic detection probe and its preparation method" disclosed in the inventor's prior patent application CN202010479710.2. The balloon is expanded by injecting ionic solution into the balloon through the perfusion tube 24, which produces mechanical stimulation to the rectal wall; adjusting the temperature of the injected solution can achieve temperature stimulation to the rectum. The intestinal cavity morphology is realized by the impedance detection of the ionic solution of the corresponding cross-section in the balloon by the surface electrode. For the specific principle, see CN201720556352.4 publication number "A high-frequency dynamic detection device for balloon morphology". The pressure is realized by the pressure sensors on the middle and rear end sensor modules; the bending angle is realized by the gyroscope in the rear end sensor, or the bending sensor in the core.

[0039] Referring to FIG. 2(A), the rigid front end is composed of a transparent housing 15 and a member 16, and is provided with a front end sensor module 4; a fastener 19 for connecting with the flexible rear end is provided thereon.

[0040] Referring to FIG. 2(B), the component 16 internally includes a endoscope module 3, a front-end sensor module 4, a multi-lumen tube 11, a data cable 12, a stimulation tube 23, an irrigation tube 24, and a fastener 19; the stimulation tube 23 is used to stimulate the anal sphincter multimodally, and the irrigation tube 24 can be used for balloon dilatation; the data cable 12 uploads the information of each module to the host computer; the pressure measuring hole 13 can be used for anal canal pressure detection.

[0041] Referring to FIG. 2(C), the plurality of front-to-back through-channels of the fastener 19 allow the colloid to flow into the groove on the rigid front end shell during the injection molding process. After the colloid is solidified, it can be tightly connected with the flexible rear end 2 as a whole, thereby ensuring the connection stability of the front and rear structures of the probe, solving the problem of insufficient connectivity between the flexible rear end 2 with poor silicone or other adhesive properties and the rigid front end 1, and helping to ensure the structural stability of the probe.

[0042] As can be seen from FIG2 , the connection relationship between the rigid front-end structure, components and fastener structure shows the position of each sensor module, the introduction and extraction method of the multi-lumen tube and cables, and the layout of the perfusion channel and other structures.

[0043] See also Figure 3 The multi-lumen tube 11 has several lumens, wherein the first lumen 52 is connected to the stimulation tube 23 (the inner diameter of the lumen is greater than 0.3 mm), the second lumen 51 (the inner diameter of the lumen is greater than 0.8 mm, meeting the perfusion speed requirement of 80 ml / min), and the third or multiple lumens 53 are provided with a pressure measuring hole 13 (the inner diameter of the lumen is greater than 0.3 mm); the opening 5 on the stimulation tube 23 is located at the rounded chamfer in the outlet direction to minimize the impact on the viewing angle of the camera.

[0044] See also Figure 4 and Figure 5 Combined with Figure 1-3, the method for detecting by using the multimodal anorectal detection endoscope probe of the present invention is to insert the multimodal anorectal detection endoscope probe through the anus, and after the patient moves to the toilet position, first perform a conventional anorectal pressure test; then inject gas or liquid through the perfusion tube 24 to expand the balloon 6, produce mechanical stimulation to the intestine, and also perform temperature stimulation to the anorectum by changing the temperature of the injected gas or liquid; and inject gas or liquid substance 43 (such as medicine, acid solution) through the stimulation tube 23 to perform biochemical stimulation on the anal sphincter 31. The three sensor modules 4, 7 and 8 and / or the bending sensor 9 and the pressure measuring hole 13 are used to collect the anorectal pressure changes and balloon temperature during the detection process, as well as the changes in the anal right angle 33; the test electrode 10 can complete the measurement of the balloon morphology (anorectal cavity morphology) when the balloon perfusion liquid is a conductive ion solution; the endoscope module 3 can clearly record the contraction / relaxation characteristics and surface morphology of the anal sphincter 31 under different physiological actions, mechanical and biochemical stimulation conditions. By analyzing the images of the coordinated movement of the internal anal sphincter 37, the levator ani muscle 38 and the external anal sphincter 39, and comparing the anorectal mechanical function characteristics and intracavitary morphological characteristics under different physiological movements, mechanical and biochemical stimulation conditions, it can be used to detect the perception and tolerance of the anorectal system; the combination of mechanical and morphological data can be used for pelvic floor anorectal coordinated diagnosis; the endoscope image can clearly identify abnormal conditions such as anorectal polyps and bleeding.

[0045] like Figure 5 As shown, the opening 5 of the stimulation tube is located at the edge of the rigid front end, allowing gas and liquid to pass through, and the injected substance can directly stimulate the internal anal sphincter. Here, a variety of gas stimulation functions can be achieved by adjusting the gas volume, injection speed (to achieve impact speed control), gas temperature, etc.; the same is true for liquid. In addition, the liquid can also contain more substances, such as different pH to achieve acid-base stimulation, different biochemical substances (such as drugs, capsaicin, etc.) or different concentrations of the same substance to achieve biochemical stimulation.

[0046] like Figure 6 As shown, it is a flowchart for sphincter movement comparison and abnormal diagnosis. The endoscope module 3 collects images, collects the first frame of images; collects the second frame of images at intervals of N frames; image preprocessing; image denoising; extracts edge information; feature matching; image segmentation; change intensity quantification; finally, the image features are combined with the anal canal pressure measured by the front sensor module 4 and the pressure measuring hole 13 on the multi-lumen tube 11, the multi-point pressure features measured by the middle sensor module 7 and the rear sensor module 8, the cavity bending features measured by the front sensor module 4, the rear sensor module 5 and / or the bending sensor 9, and the cross-sectional morphological features of the expandable balloon 6 outside the flexible rear end 2 measured by the test electrode 10 for decision fusion and determination results.

[0047] Among them, the image denoising is used to identify the folding line of the internal anal sphincter as a reference feature, and the edge features of the curve during anal levation and force displacement are used as the motion boundary; then feature matching is performed on each frame of the image, and block processing is performed according to the curve folding method; after the block division is completed, a curve of the block size change over time and a grayscale projection change curve of each edge curve are drawn; finally, a comprehensive analysis is performed through the block size change frequency and curve motion characteristics under different stimulation conditions and functional indicators such as pressure, shape and angle at the corresponding time, so as to realize the prediction and evaluation of pathophysiological abnormalities of physiological movement abnormalities such as sphincter spasm and tremor.

[0048] Furthermore, the image is divided into different small blocks according to the different sphincter force conditions. By retrieving the image color at the edge and the foreground color of the picture, the gradient operator Roberts of the cross difference of the edge pixel relative to other pixel points is calculated in the Gray grayscale image as the judgment condition:

[0049] Among them, s x (i, j) is the horizontal filtering value of the pixel, s y (i, j) is the vertical filtering value of the pixel.

[0050] Further, the change intensity is quantified as:

[0051] First, the edge line (folding line) between each block is modeled and fitted using the least squares curve fitting method to obtain an approximate fitting curve. The mean square error MSE (δ) is used to measure the accuracy of the curve fitting model. The mean square error of each fitting equation is compared, and the one with the smallest MSE (δ) is the best curve fitting equation:

[0052] Y n*1 =Xβ n*n*1 +ε n*1 +Δ n*1 , D = σ 2 I

[0053]

[0054] X and Y are the ordinates and abscissas of the fitting curve; β is the fitting curve parameter, ε is the fitting model error; Δ is the accidental error of the fitting data Y, and E(Δ)=0; n is the number of observations of the fitting curve; t is the number of parameters of the fitting curve; σ 2 is the observed data variance; I is the unit matrix;

[0055] Then, the approximate equation of the folding line obtained by modeling is used to calculate the area of ​​each block through the calculus theorem, so as to analyze the subsequent curves of the change of the block area size over time and the grayscale projection change curve of each edge curve; the indicators obtained include the change speed (or frequency) and peak value of the block size, the edge (folding line included) jitter frequency and peak value, etc.

[0056] Furthermore, the decision fusion includes two parts: parameter set expansion and data fusion;

[0057] The parameter set expansion uses two methods: fractal dimension and singular entropy. The fractal dimension calculation method is:

[0058]

[0059] Where ε is the length of one side of a small cube, N(ε) is the number of small cubes covering the measured shape. The dimension formula means that the dimension of the shape is determined by covering the measured shape with small cubes with a side length of ε.

[0060] Singular entropy calculation method: Use EMD algorithm to decompose the characteristic signal and obtain n IMF components, c1, c2, ...c n , forming the initial eigenvector matrix A, performing singular value decomposition on A to obtain singular values ​​δ1, δ2, ...δ n , normalize each component:

[0061] Calculate the singular value entropy according to the information entropy formula:

[0062] The data fusion is firstly performed through a shared spatial high-level semantic data fusion model X=F(θ1,θ2,…,θ j ,X i ),

[0063] Among them, F(·) is the feature mapping function learned by the neural network, X i represents the output of the neural network, X represents the high-level semantic features of the neural network, and the optimal parameter set θ = {θ1, θ2, …, θ j};

[0064] Then use this optimal mapping function to express the high-level semantics of the input features; finally use the joint probability distribution of the Bayes network

[0065] The associated probability distributions of single Bayesian inferences are combined into a joint posterior probability distribution function, and the likelihood function of the joint distribution function is minimized. Finally, the decision classifier is used to realize the abnormal analysis of anorectal sphincter movement and nerve reflex function.

[0066] A method for applying a multimodal anorectal detection endoscope probe, wherein the multimodal anorectal detection endoscope probe is used for multimodal stimulation of the anorectal area, wherein the stimulation electrical signal acts on the internal anal sphincter through the electrical stimulation electrode 17 to complete the electrical stimulation; the gas and / or liquid acts on the internal anal sphincter through the stimulation tube 23 through its opening, and the physical and biochemical stimulation is completed by adjusting the physical and biochemical characteristics and injection method of the gas and / or liquid; the expandable balloon 24 is expanded by injecting ion solution into the rectum and sigmoid colon through the perfusion tube 24, and the intestine is mechanically and thermally stimulated by changing the temperature and volume of the injected solution.

[0067] The probe is used to evaluate the anorectal sphincter movement and nerve reflex function; when the anorectum is subjected to different stimuli, the endoscope module 3 will collect the internal anal sphincter movement image, the front sensor module 4 detects the rectal terminal pressure, the pressure measuring hole 13 on the multi-lumen tube 11 detects the anal canal pressure, the middle sensor module 7 detects the intestinal pressure exerted on the expandable balloon 6, the rear sensor module 8 detects the intestinal propulsion force exerted on the rear end of the probe, the posture sensor and / or bending sensor 9 in the front sensor module 4 and the rear sensor module 8 detects the change of the anal right angle, and a plurality of test electrodes 10 distributed on the surface of the flexible rear end 2 detect the intestinal cavity morphology; the functional indicators such as pressure, morphology and angle are comprehensively analyzed with the movement image, so as to realize the evaluation of the anorectal sphincter movement and nerve reflex function.

[0068] The present invention has complete biochemical and imaging detection functions, meeting the functional requirements of organic lesions and sensory function diagnosis. By collecting the anorectal mechanical function characteristics and sphincter movement characteristics under different physiological movements, mechanical, biochemical stimulation and electrical stimulation conditions for comparative analysis, the diagnosis of anorectal sensory function and sphincter function is achieved; and the sphincter folding line is used as the identification feature, and the anal sphincter spasm, tremor and other physiological movements are detected by image comparison for abnormal analysis, and the image is combined with biomechanical information to detect the correlation between anorectal organic lesions and functional lesions. By introducing multiple modal stimulation methods and motion image acquisition functions, the lack of effective neural and imaging function evaluation in the diagnosis of organic lesions and sensory functions of functional detection technology is supplemented.

[0069] See also Figure 7, schematic diagram of the recognition and movement of the internal anal sphincter folding line in a specific implementation method. The multimodal anorectal detection endoscope probe is used to detect camera images to directly diagnose rectal varicose veins (internal hemorrhoids) and internal anal sphincter folding. The collection of multiple physiological function parameters under multimodal stimulation can effectively evaluate the impact of such organic lesions on defecation function. The main evaluation criteria include synergy, anal canal opening 85 (including opening size, sphincter coordination, etc.), and compliance (obtained by joint calculation of mechanical and geometric parameters). In the collection and comparison of the internal anal sphincter movement, the internal anal sphincter folding line 87 will be first identified as a characteristic curve, and the characteristics of the anus lifting and force discharge will be used as the movement boundary; then the continuous images will be feature matched and the images will be divided into blocks along the curve; after the block division is completed, the curve of the size change of the block (93, 94) over time and the grayscale projection change curve of each edge curve will be drawn; finally, the abnormality of physiological movement such as sphincter spasm and tremor will be reflected by the abnormality of the block size change frequency and the curve movement characteristics.

[0070] Purpose of test results: Comparative analysis of anorectal mechanical function characteristics and sphincter morphological characteristics under different physiological movements, mechanical and biochemical stimulation conditions can be used to detect anorectal perception and tolerance; the combination of mechanical and morphological data can be used for pelvic floor anorectal collaborative diagnosis; endoscopic images can clearly identify abnormal conditions such as anorectal polyps and bleeding, and can also well detect the impact of polyps on defecation function.

[0071] In addition to the stimulation modes that the probe itself can achieve mentioned above, the probe can also be combined with external additional stimulation methods such as peripheral skin nerve touch stimulation (perineum touch), transcranial magnetic stimulation and spinal nerve stimulation.

[0072] It should be noted here that the outer diameter of the multi-lumen catheter itself can be used as a ruler in image analysis (i.e., the outer diameter of the catheter is known, and the geometric information of the surrounding image is obtained through the proportional relationship). With the assistance of the camera, the structure can be better positioned during the placement of the probe compared to existing functional probes. The probe can be placed at different distances from the anal canal, that is, in some views: the lower part of the rectum can be focused; it can also be focused on the uppermost part of the anal sphincter (near the anal right angle, which is an important physiological part of the puborectalis muscle 34 that suspends the lower rectum). At this time, any lateral movement of the probe captured by the camera can be used as an indicator of relaxation / contraction of the puborectalis muscle.

[0073] The probe is designed and manufactured to simulate real intestinal contents. It can perform multimodal stimulation on the rectum and internal anal sphincter respectively, collect physiological phenotypic characteristics such as pressure, strain characteristics, anal angle, sphincter movement images, etc. of the anorectal response to various stimuli, and evaluate sphincter movement and nerve reflex function through sphincter movement collection and comparison. It can be used for anorectal disease diagnosis and drug pharmacology analysis.

[0074] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit the technical solution. Those skilled in the art should understand that those modifications or equivalent substitutions of the technical solution of the present invention that do not depart from the purpose and scope of the technical solution should be included in the scope of the claims of the present invention.

Claims

1. A multi-modal anorectal detection endoscope probe, characterized in that: It consists of two parts: a rigid front end (1) and a flexible rear end (2), wherein the rigid front end (1) and the flexible rear end (2) are connected by a fastener (19); The rigid front end (1) is composed of a transparent shell and internal components; the internal components include a multi-lumen tube (11), a stimulation tube (23), an irrigation tube (24) and a connector, and is also provided with a peephole module (3), a front sensor module (4), an electrical stimulation electrode (17), an external multi-lumen tube (11) and a data cable (12); wherein the peephole module (3) is used for image acquisition, the front sensor module (4) is used for detecting the pressure at the end of the rectum, and the pressure measuring hole (13) on the multi-lumen tube (11) is used for detecting the anal canal pressure; The flexible rear end (2) is bendable, and the flexible rear end (2) is wrapped with an expandable balloon (6) on the outside, which contains a middle sensor module (7) and a rear end sensor module (8) and / or a bending sensor (9), and a plurality of test electrodes (10) are distributed on the surface of the flexible rear end (2); The endoscope module (3) is used for image acquisition, acquiring a first frame of image; acquiring a second frame of image at intervals of N frames; image preprocessing; image denoising; extracting edge information; feature matching; image segmentation; and change intensity quantification; and finally, the image features are combined with the anal canal pressure measured by the front sensor module (4) and the pressure measuring hole (13) on the multi-lumen tube (11), the multi-point pressure features measured by the middle sensor module (7) and the rear sensor module (8), the cavity bending features measured by the front sensor module (4), the rear sensor module (8) and / or the bending sensor (9), and the cross-sectional morphological features of the expandable balloon (6) outside the flexible rear end (2) measured by the test electrode (10) to make a decision fusion and determine the result; The intensity of the change is quantified as: First, the edge line (folding line) between each block is modeled and fitted using the least squares curve fitting method to obtain an approximate fitting curve. The mean square error MSE (δ) is used to measure the accuracy of the curve fitting model. The mean square error of each fitting equation is compared, and the one with the smallest MSE (δ) is the best curve fitting equation: Y n*1 =Xβ n*n*1 +e n*1 +D n*1 ,D=σ 2 I X and Y are the ordinates and abscissas of the fitting curve; β is the fitting curve parameter, ε is the fitting model error; Δ is the accidental error of the fitting data Y, and E(Δ)=0; n is the number of observations of the fitting curve; t is the number of parameters of the fitting curve; σ 2 is the observed data variance; I is the unit matrix; Then, using the approximate equation of the folding line obtained by modeling, the area of ​​each block is calculated by calculus theorem, so as to analyze the subsequent curves of the change of the block area size over time and the grayscale projection change curve of each edge curve; the indicators obtained include the change speed and peak value of the block size, the edge jitter frequency and peak value, etc. The decision fusion includes two parts: parameter set expansion and data fusion; The parameter set expansion uses two methods: fractal dimension and singular entropy. The fractal dimension calculation method is: Where ε is the length of one side of a small cube, N(ε) is the number of small cubes covering the measured shape. The dimension formula means that the dimension of the shape is determined by covering the measured shape with small cubes with a side length of ε. Singular entropy calculation method: Use EMD algorithm to decompose the characteristic signal and obtain n IMF components, c1, c2, ...c n , forming the initial eigenvector matrix A, performing singular value decomposition on A to obtain singular values ​​δ1, δ2, ...δ n , normalize each component: Calculate the singular value entropy according to the information entropy formula: The data fusion is firstly performed through a shared spatial high-level semantic data fusion model X = F (θ1, θ2, L, θ j ,X i ), Among them, F(·) is the feature mapping function learned by the neural network, X i represents the output of the neural network, X represents the high-level semantic features of the neural network, and the optimal parameter set θ = {θ1, θ2, …, θ j }; Then use this optimal mapping function to express the high-level semantics of the input features; finally use the joint probability distribution of the Bayes network The associated probability distributions of single Bayesian inferences are combined into a joint posterior probability distribution function, and the likelihood function of the joint distribution function is minimized. Finally, the decision classifier is used to realize the abnormal analysis of anorectal sphincter movement and nerve reflex function.

2. The multimodal anorectal detection endoscope probe according to claim 1, characterized in that: The front-end sensor module (4), the middle sensor module (7) and the rear-end sensor module (8) respectively contain a variety of sensors such as pressure, temperature, posture, etc. and / or a single-chip microcomputer.

3. The multimodal anorectal detection endoscope probe according to claim 1, characterized in that: The multi-lumen tube (11) has a plurality of lumens, wherein the first lumen (52) is connected to the stimulation tube (23), the second lumen (51) is connected to the irrigation tube (24), and the third or multiple lumens (53) are provided with a pressure measuring hole (13); the opening of the stimulation tube (23) is located at a rounded chamfered edge in the outlet direction; the irrigation tube (24) is used for balloon dilation; and the pressure measuring hole (13) is used for anal canal pressure detection.

4. The multimodal anorectal detection endoscope probe according to claim 1, characterized in that: The fastener (19) has a plurality of channels extending from front to back, through which the colloid can flow into the grooves on the outer shell of the rigid front end (1) during the injection molding process. After the colloid is solidified, it can be tightly connected to the flexible rear end (2) to ensure the connection stability of the front and rear structures of the probe.

5. The multimodal anorectal detection endoscope probe according to claim 3, characterized in that: The inner diameter of the first cavity is greater than 0.3 mm; the inner diameter of the second cavity is greater than 0.8 mm, meeting the perfusion speed requirement of 80 ml / min; and the inner diameter of the third cavity is greater than 0.3 mm.

6. The multimodal anorectal detection endoscope probe according to claim 1, characterized in that: The image denoising is used to identify the folding line of the internal anal sphincter as a reference feature, and the curve edge features during levator anus and force expulsion as the motion boundary; then feature matching is performed on each frame of the image, and block processing is performed according to the curve folding method; After the block division is completed, the curve of block size change over time and the grayscale projection change curve of each edge curve are drawn; finally, the frequency of block size change and curve movement characteristics under different stimulation conditions are comprehensively analyzed with functional indicators such as pressure, shape and angle at the corresponding moment to achieve the prediction and evaluation of pathophysiological abnormalities of physiological movement abnormalities such as sphincter spasm and tremor.

7. The multimodal anorectal detection endoscope probe according to claim 1, characterized in that: The image is divided into different small blocks according to the different sphincter force conditions. The image color at the edge and the foreground color of the image are retrieved, and the gradient operator Roberts of the cross difference of the edge pixel relative to other pixels is calculated in the grayscale image as the judgment condition: Among them, s x (i, j) is the horizontal filtering value of the pixel, s y (i, j) is the vertical filtering value of the pixel.

8. An application method of a multi-modal anorectal detection endoscope probe, characterized in that: A multimodal anorectal detection endoscope probe as described in any one of claims 1 to 7 is used for multimodal stimulation of the anorectal area, wherein the stimulation electrical signal acts on the internal anal sphincter through the electrical stimulation electrode (17) to achieve electrical stimulation; gas and / or liquid acts on the internal anal sphincter through the stimulation tube (23) through its opening, and physical and biochemical stimulation is achieved by adjusting the physical and biochemical characteristics and injection method of the gas and / or liquid; an expandable balloon (6) is injected into the rectum and sigmoid colon through an infusion tube (24) to achieve expansion, and mechanical and thermal stimulation of the intestine is achieved by changing the temperature and volume of the injected solution.

9. The method for applying the multimodal anorectal detection endoscope probe according to claim 8, characterized in that: The probe is used to evaluate the movement of the anorectal sphincter and the nerve reflex function; when the anorectum is subjected to different stimuli, the endoscope module (3) will collect the movement image of the internal anal sphincter, the front sensor module (4) detects the pressure at the end of the rectum, the pressure measuring hole (13) on the multi-lumen tube (11) detects the anal canal pressure, the middle sensor module (7) detects the intestinal pressure exerted on the expandable balloon (6), the rear sensor module (8) detects the intestinal propulsion force exerted on the rear end of the probe, the posture sensor and / or bending sensor (9) in the front sensor module (4) and the rear sensor module (8) detects the change of the anal right angle, and a plurality of test electrodes (10) distributed on the surface of the flexible rear end (2) detect the intestinal cavity morphology; the functional indicators such as pressure, morphology and angle are comprehensively analyzed with the movement image, so as to realize the evaluation of the movement of the anorectal sphincter and the nerve reflex function.

Images