CN114795095B

CN114795095B - A multi-modal anorectal detection endoscope probe and its application

Info

Publication number: CN114795095B
Application number: CN202210376076.9A
Authority: CN
Inventors: 孙大明; 汉斯·格里格森; 黄智勇; 吴朝学
Original assignee: Chongqing Gaobo Ruiqi Technology Development Co ltd
Current assignee: Chongqing Gaobo Ruiqi Technology Development Co ltd
Priority date: 2022-04-11
Filing date: 2022-04-11
Publication date: 2025-02-25
Anticipated expiration: 2042-04-11
Also published as: CN114795095A

Abstract

The invention provides a multi-mode anorectal detection speculum probe and application thereof, wherein the probe has the function of multi-mode stimulation, and comprises a rigid front end and a flexible rear end, wherein the front end has the functions of image acquisition, pressure detection, multi-mode stimulation of internal anal sphincter, and the like, the flexible rear end can be bent, and the exterior of the flexible rear end is wrapped by an expandable saccule, so that the probe has the functions of intestinal cavity morphology, pressure, bending angle detection, intestinal tract machinery and temperature stimulation. The probe simulates the design and manufacture of real intestinal contents, can respectively perform multi-mode stimulation on rectum and internal anal sphincter, collect physiological characteristic parameters such as pressure, stress-strain, cavity morphology, right angle of anus, peristalsis and the like of the anus rectum for coping with various stimulations, and evaluate sphincter exercise and nerve reflex functions by comparing with sphincter exercise images, thus being applicable to anorectal disease diagnosis, pharmacological analysis of medicines and the like.

Description

Multi-mode anorectal detection speculum probe and application thereof

Technical Field

The invention relates to a multi-mode anorectal detection speculum probe and application thereof, and belongs to the technical field of medical equipment.

Background

Gastrointestinal tract movement, anorectal sensation, rectal contractions, coordination of pelvic floor muscle groups, intestinal lumen volume, etc. can all directly cause functional disorders, causing slow colonic transport and drainage. For example, decreased sense of fullness in the colon results in a contraction of fecal discharge function, which is very common in patients with dysuria syndrome and is closely associated with structural abnormalities such as megacolon, dysfunctional bowel movements due to abnormal synergia of pelvic floor muscle groups, often manifested as relaxation of pelvic floor muscles, and abnormal biomechanics due to tissue deformities (e.g., intussusception, rectal prolapse, etc.) inhibiting normal fecal excretion. These etiologies can be classified into two categories, mechanical structural and functional abnormalities. Abnormalities in mechanical structure can be assessed by digital rectal examination and medical imaging techniques. Functional abnormalities need to be comprehensively analyzed by various methods focused on examination of mechanical properties of tissues.

In the prior art, CN201580070098.0 discloses an electronic device that can be placed in the rectum or colon for biomechanical study of bowel movement. Comprising a flexible core made of solid or semi-solid material, which is bendable or compressible, inside or on the surface of which one or more sensors are arranged, respectively. One of the sensors can detect the pressure of the device in the digestive tract or in the expansion process, and a plurality of impedance measuring electrodes are arranged on the surface of the core body and can test the impedance of the corresponding section of the device in the digestive tract or in the expansion process, and the impedance data of the section can be used for calculating the sectional area of the application. Can be used for detecting the intestinal tract mechanical function in the natural defecation process. CN201720556352.4 discloses a balloon form high-frequency dynamic detection device, which comprises a detection probe and a detection circuit, wherein the detection probe is an elongated catheter, N annular electrode plates are arranged on the detection probe, the detection circuit comprises an MCU processor, the MCU processor generates a constant-current square wave signal, the constant-current square wave signal is respectively transmitted to the head excitation electrode and the tail excitation electrode of the detection probe by an excitation signal converter at a certain frequency, potential difference signals which are uniformly processed by signals between adjacent electrodes in a signal acquisition circuit are sequentially transmitted to a pre-filter for filtering, differential amplification, low-pass filtering and a high-precision A/D converter for converting analog signals into digital signals and transmitting the digital signals to the MCU processor, and finally the MCU processor performs serial port communication with an upper computer according to a fixed communication protocol, and the detection circuit can be used for detecting the cross section forms of N1 balloons in real time, so that the problem of circuit miniaturization of an impedance surface measurement system in a probe system is solved. CN202010479710.2 discloses a medical bionic detection probe and a preparation method thereof, wherein a flexible core body, a balloon and a perfusion catheter in the probe are reasonably designed, a plurality of split functional modules are precisely positioned in the flexible core body, all functional components are electrically connected by a spiral flat cable, and extend out from the rear end of the core body through a lead and are connected with an external upper computer, so that the problems of complex structure, single function, poor circuit stability and detection precision in the prior art are effectively solved.

However, the above technology mainly focuses on the detection of functional indexes in the natural defecation of anorectal, has very short detection functions in neurology and imaging, and is difficult to meet the functional requirements of organic lesions and perception function diagnosis.

Disclosure of Invention

Aiming at the defects existing in the prior art, the invention aims to provide a multi-mode anorectal detection speculum probe which solves the defects of the prior art that the detection functions in biochemistry and imaging are lacking, so as to meet the functional requirements of organic pathological changes and perception function diagnosis.

The invention adopts the following technical means:

the multi-mode anorectal detection speculum probe is characterized by comprising a rigid front end and a flexible rear end, wherein the rigid front end and the flexible rear end are connected by adopting a fastener;

the rigid front end consists of a transparent shell and an internal component, wherein the internal component comprises a multi-cavity tube, a stimulation tube, a perfusion tube and a connecting piece, and is also provided with an endoscope module, a front end sensor module, an electric stimulation electrode, an external multi-cavity tube and a data cable, wherein the endoscope module is used for image acquisition, the front end sensor module is used for detecting the pressure of the tail end of a rectum, and a pressure measuring hole on the multi-cavity tube is used for detecting the pressure of an anal canal;

the flexible rear end is bendable, the expandable saccule is wrapped outside the flexible rear end, the middle sensor module and the rear end sensor module and/or the bending sensor are contained in the expandable saccule, and a plurality of test electrodes are distributed on the surface of the flexible rear end.

Further, the front end sensor module, the middle sensor module and the rear end sensor module respectively comprise various sensors such as pressure, temperature, gesture and/or a singlechip.

The multi-cavity tube is provided with a plurality of cavity channels, wherein a first cavity channel is connected with the stimulation tube, a second cavity channel is connected with the perfusion tube, a pressure measuring hole is formed in one or more cavity channels, the opening of the stimulation tube is positioned at the round chamfer edge in the wire outlet direction, the perfusion tube is used for balloon expansion, and the pressure measuring hole is used for anal canal pressure detection.

The inner diameter of the cavity of the first cavity is larger than 0.3mm, the inner diameter of the second cavity is larger than 0.8mm, the requirement of the infusion speed of 80ml/min is met, and the inner diameter of the third cavity is larger than 0.3mm.

The multi-mode stimulation function comprises the steps of enabling stimulation electric signals to act on internal anal sphincter through an electric stimulation electrode to complete electric stimulation, enabling gas or/and liquid to act on internal anal sphincter through an opening of the stimulation tube, enabling physical and biochemical stimulation to be completed through adjusting physical and biochemical characteristics and injection modes of the gas or/and liquid, enabling the expandable saccule to be implanted with ionic solution through the injection tube to achieve expansion at rectum and sigmoid colon, and enabling intestinal canal to be stimulated mechanically and thermally through changing temperature and volume of the injected solution.

Further, the anorectal sphincter motor and nerve reflex function evaluation comprises the steps that when anorectal is stimulated differently, the endoscope module collects internal anal sphincter moving images, the front end sensor module detects the tail end pressure of rectum, the pressure measuring holes in the multi-cavity tube detect anal canal pressure, the middle sensor module detects the intestinal canal pressure borne by the expandable saccule, the rear end sensor module detects the intestinal canal propelling force borne by the rear end of the probe, the gesture sensors and/or the bending sensors in the front end sensor module and the rear end sensor module detect right angle change of anus, the plurality of test electrodes distributed on the surface of the flexible rear end detect the shape of an intestinal cavity, and functional indexes such as pressure, shape and angle are comprehensively analyzed with the moving images, so that the anorectal sphincter motor and nerve reflex function evaluation is achieved.

The sphincter muscle movement collection comparison method comprises the steps of firstly identifying the folding line of the sphincter muscle in the anus as a characteristic curve, taking the characteristics of the anus when the anus is lifted and the force is discharged as a movement boundary, then carrying out characteristic matching on each frame of image, carrying out block dividing treatment along the curve, drawing a change curve of the size of a block along with time and a gray projection change curve of each edge curve after the block dividing is finished, and finally reacting to physiological movement abnormality such as sphincter cramps, flutter and the like through the change frequency of the size of the block and the characteristic of movement of the curve.

The invention also provides an application method of the multi-mode anorectal detection speculum probe, which is used for multi-mode stimulation of anorectal parts, stimulation electric signals act on internal anal sphincters through electric stimulation electrodes to complete electric stimulation, gas or/and liquid acts on the internal anal sphincters through the opening of the stimulation tube, physical and biochemical stimulation is completed through adjusting physical and biochemical characteristics and injection modes of the gas or/and the liquid, and the expandable saccule is used for injecting ionic solution into the rectum and sigmoid colon parts through the injection tube to realize expansion, and the temperature and the volume of the injected solution are changed to perform mechanical and temperature stimulation on intestinal tracts.

Further, the probe is used for evaluating the anorectal sphincter motor and the nerve reflex function; when anorectum is stimulated differently, the endoscope module collects moving images of internal anal sphincter, the front end sensor module detects pressure at the tail end of rectum, the pressure measuring hole on the multi-cavity tube detects pressure of anal canal, the middle sensor module detects pressure of intestinal canal borne by the expandable saccule, the rear end sensor module detects propulsion of intestinal canal borne by the rear end of the probe, the gesture sensors and/or bending sensors in the front end sensor module and the rear end sensor module detect right angle change of anus, a plurality of test electrodes distributed on the surface of the flexible rear end detect intestinal cavity form, and functional indexes such as pressure, form, angle and the like are comprehensively analyzed with the moving images, so that evaluation of anorectum sphincter movement and nerve reflection functions is realized.

Compared with the prior art, the invention has the following beneficial effects:

1. The multi-mode anorectal detection endoscope probe provided by the invention consists of a rigid front end and a flexible rear end, wherein the rigid front end has the functions of image acquisition, pressure detection, perfusion stimulation and the like, the flexible rear end can be bent, and the exterior of the flexible rear end is wrapped by an expandable balloon and has the functions of impedance test, pressure detection, bending angle detection, mechanical and temperature stimulation. The probe simulates the design and manufacture of the real intestinal contents, can perform multi-mode stimulation on anorectal tissues, simultaneously measure anorectal multipoint pressures, comprises important physiological characteristics such as strain characteristics, right angles of anus, shrinkage images of anal sphincter and the like, can inject different medicine solutions through a stimulation pipe, and can directly stimulate the internal anal sphincter by the medicine, so that the anorectal tissues can generate corresponding movements. Such as an evacuation-promoting drug, which allows for easier relaxation of the internal sphincter, the rectal end and anal canal pharmacology are lower than when simulated bowel movements are performed without drug stimulation. Other drugs for anorectal treatment are similar, and the implementation mode is to detect whether the anorectal response is normal or not when the anorectal response is to be tested by the drug, or the anorectal nerve reflex characteristics caused by the drug are measured when the attribute of the drug or the physiological response is unknown, so that pharmacological analysis is realized. Can be used for sphincter function evaluation, pharmacological analysis of medicines and the like. The anorectal sensing function and the sphincter function are diagnosed by collecting the anorectal mechanical function characteristics and the sphincter movement characteristics under different physiological actions, mechanical, biochemical stimulation and electric stimulation conditions for comparison analysis, the sphincter folding line is taken as the identification characteristic, the physiological movements such as sphincter spasm and flutter in the anus are detected through image comparison for analysis, the image is combined with biomechanical information, and the correlation between anorectal organic lesions and functional lesions is detected. The defects of the functional detection technology in the aspects of organic lesion and perception function diagnosis lack of effective nerve and image function evaluation are overcome by introducing the stimulation modes and the motion image acquisition functions of multiple modes.

2. The multi-mode anorectal detection endoscope probe provided by the invention is particularly provided with the fastening piece, the glue can flow into the groove on the rigid front end shell through the plurality of front-back through channels in the glue injection molding process, the glue can be tightly connected with the flexible rear end into a whole after being solidified, and the connection stability of the front-back structure of the probe is ensured. The problem of by silica gel or other poor flexible rear end of adhesive property with the connectivity of rigidity front end not enough is solved, is favorable to guaranteeing the structural stability of probe, has avoided the secondary to consolidate simultaneously, has simplified processing technology flow.

3. Compared with the existing functional probe, the invention has the advantage that the tissue structure can be better positioned in the process of placing the probe by the aid of the camera to acquire the image. The probe can be placed at different distances from the anal canal, i.e. in certain views, the lower part of the rectum can be focused, and the probe can also be placed at the puborectal muscle for a large number of multi-mode stimulation analysis and detection, and any lateral movement of the probe captured by the camera can be used as an index of puborectal muscle relaxation/contraction.

4. The invention also provides an application method of the multi-mode anorectal detection endoscope probe, which has the characteristics of convenience in operation, complete functions and the like.

Drawings

FIG. 1 is a schematic diagram of a multi-mode anorectal detection scope probe structure of the invention;

FIG. 2 is a schematic illustration of the rigid front end structure, components and fastener structure of FIG. 1A, B, C, respectively;

FIG. 3 is a schematic view of the multi-lumen tube of FIG. 1;

FIG. 4 is a schematic illustration of the placement site in this embodiment;

FIG. 5 is a schematic diagram of a multi-modal stimulation pattern in this embodiment;

FIG. 6 is a flow chart for sphincter exercise contrast and anomaly diagnosis in this embodiment;

figure 7 is a schematic diagram (A, B) of internal anal sphincter fold line identification and movement in an embodiment.

In the figures, 1-rigid front end, 2-flexible back end, 3-speculum module, 4-front end sensor module, 5-fenestration, 6-expandable balloon, 7-mid sensor module, 8-back end sensor module, 9-bending sensor, 10-test electrode, 11-multi-lumen tube, 12-data cable, 13-pressure tap, 15-transparent housing, 16-member, 17-electro-stimulation electrode, 19-fastener, 23-stimulation tube, 24-perfusion tube;

30-probe, 31-anal sphincter, 33-anal right angle, 34-puborectalis, 37-internal anal sphincter, 38-levator ani, 39-external anal sphincter, 43-gaseous or liquid substance;

51-second lane, 52-first lane, 53-third or multiple lanes;

85-about muscle fold line 1,87-about muscle fold line 2,93-drawing tile 1, 94-drawing tile 2.

Detailed Description

The invention is described in further detail below with reference to the drawings and the detailed description.

As shown in figure 1, the multi-mode anorectal detection endoscope probe consists of 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 provided with a speculum module 3, a front end sensor module 4, an opening 5, an electric stimulation electrode 17, an external multi-cavity tube 11 and a data cable 12, wherein the speculum module 3 is used for image acquisition, the front end sensor module 4 is used for detecting the pressure of the tail end of a rectum, the pressure measuring hole 13 on the multi-cavity tube 11 is used for detecting the pressure of an anal canal, and the front end sensor module 4 is used for detecting the pressure applied to the front end of a probe.

The flexible rear end 2 is externally wrapped with an expandable saccule 6, wherein a middle sensor module 7 and a rear end sensor module 8 are contained, and/or a bending sensor 9 is/are arranged, and a plurality of test electrodes 10 are distributed on the surface of the flexible rear end, so that the flexible rear end has the functions of impedance test, 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 respectively comprise various sensors such as pressure, temperature, gesture and/or a singlechip.

The probe has multi-modal functionality. The probe simulates the design and manufacture of the real intestinal contents, can perform multi-mode stimulation on anorectal tissues, simultaneously measure important physiological characteristics such as anorectal multipoint pressure, strain characteristics, anal right angle, anal sphincter contraction images and the like, and can be used for sphincter function evaluation, pharmacological analysis of medicines and the like.

The flexible rear end is made of silica gel, and the internal circuit is of a split type module structure. The circuit connection mode refers to a medical bionic detection probe and a preparation method thereof disclosed in a prior patent application CN202010479710.2 of the inventor. The balloon is inflated by injecting an ion solution into the balloon through the perfusion tube 24 to generate mechanical stimulation to the rectum wall, and the temperature of the injected solution is adjusted to realize temperature stimulation to the rectum. The intestinal cavity shape is realized by detecting the impedance of the surface electrode to the ionic solution with the corresponding section in the saccule, the specific principle is shown in CN201720556352.4 publication No. "a saccule shape high-frequency dynamic detection device", the pressure is realized by the pressure sensors on the middle and rear end sensor modules, and the bending angle is realized by the gyroscope in the rear end sensor or the bending sensor in the core body.

Referring to fig. 2 (a), the rigid front end is composed of a transparent housing 15 and a member 16, provided with a front end sensor module 4, on which a fastener 19 for connection with the flexible rear end is provided.

Referring to fig. 2 (B), the member 16 internally comprises a speculum module 3, a front end sensor module 4, a multi-cavity tube 11, a data cable 12, a stimulation tube 23, a perfusion tube 24 and a fastening piece 19, wherein the stimulation tube 23 is used for stimulating anal sphincter multi-mode, the perfusion tube 24 can be used for balloon dilation, the data cable 12 uploads information of each module to an upper computer, and the pressure measuring holes 13 can be used for anal canal pressure detection.

Referring to fig. 2 (C), the multiple front-back through channels of the fastener 19 can enable the glue to flow into the groove on the rigid front-end housing in the glue injection molding process, the glue can be tightly connected with the flexible rear end 2 into a whole after solidification, so as to ensure the connection stability of the front-back structure of the probe, solve the problem of insufficient connectivity between the flexible rear end 2 and the rigid front end 1 due to poor adhesive property of the silica gel or other materials, and be beneficial to ensuring the structural stability of the probe.

As can be seen from fig. 2, the connection of the rigid front end structure, the components and the fastener structure shows the position of each sensor module, the way in which the multilumen tubing and the cables are led in and out, and the layout of the irrigation lumen and other structures.

Referring to fig. 3, the multi-cavity tube 11 has several channels, wherein the first channel 52 is connected with the stimulating tube 23 (the inner diameter of the cavity is larger than 0.3 mm), the second channel 51 (the inner diameter of the cavity is larger than 0.8mm and meets the requirement of the filling speed of 80 ml/min), the third channel or channels 53 are provided with pressure measuring holes 13 (the inner diameter of the cavity is larger than 0.3 mm), and the opening 5 on the stimulating tube 23 is positioned at the round chamfer of the outlet direction so as to reduce the visual angle influence on the camera as much as possible.

Referring to fig. 4 and 5 in combination with fig. 1-3, the method for detecting the anorectal by using the multi-mode anorectal detection endoscope probe according to the present invention is adopted, the multi-mode anorectal detection endoscope probe is placed through anus, after a patient moves to a toilet position, a conventional anorectal pressure measurement check is performed first, then the balloon 6 is inflated by injecting gas or liquid through the perfusion tube 24, mechanical stimulation is generated to the intestinal tract, temperature stimulation can be performed to the anorectal by changing the temperature of the injected gas or liquid, and biochemical stimulation can be performed to the anal sphincter muscle 31 by injecting gas or liquid substances 43 (such as medicines and acid liquid) through the stimulation tube 23. The three sensor modules 4, 7 and 8 and/or the bending sensor 9 and the pressure measuring hole 13 are used for collecting anorectal pressure change and balloon temperature and anal right angle 33 change in the detection process, the test electrode 10 can finish measurement of balloon morphology (anorectal cavity morphology) when the balloon perfusate is conductive ion solution, and the endoscope module 3 can clearly record contraction/relaxation characteristics and surface morphology of the anal sphincter 31 under different physiological actions, mechanical and biochemical stimulation conditions. The method can be used for detecting the perception and tolerance of anorectum by analyzing the image of the cooperative motion state of the internal anal sphincter 37, the levator ani muscle 38 and the external anal sphincter muscle 39 and comparing and analyzing the anorectum mechanical function characteristics and the intracavity morphological characteristics under different physiological actions, mechanical and biochemical stimulation conditions, the combination of mechanical and morphological data can be used for the cooperative diagnosis of the pelvic floor anorectum, and the abnormal conditions such as anorectum polyp, bleeding and the like can be clearly identified by using the endoscope image.

As shown in fig. 5, the opening 5 of the stimulation tube is located at the edge of the rigid front end, allowing the passage of gases and liquids, and the injected substance can directly stimulate the internal anal sphincter. The gas quantity, the injection speed (the control of the impact speed) and the gas temperature can be adjusted to realize various gas stimulation functions, and the same liquids are used. In addition, the liquid can also contain more substances, such as different pH values to realize acid-base stimulation, different biochemical substances (such as medicines, capsaicin and the like) or different concentrations of the same substances to realize biochemical stimulation.

As shown in fig. 6, a flow chart for sphincter movement comparison and abnormality diagnosis. The method comprises the steps of acquiring images by an endoscope module 3, acquiring a first frame of images, acquiring a second frame of images at intervals of N frames, preprocessing the images, denoising the images, extracting edge information, matching features, dividing the images, quantifying the change intensity, and finally carrying out decision fusion and judgment on the image features and the anal canal pressure measured by a front end sensor module 4 and a pressure measuring hole 13 on a multi-cavity tube 11, the multipoint pressure features measured by a middle sensor module 7 and a rear end sensor module 8, the cavity bending features measured by the front end sensor module 4, the rear end sensor module 5 and/or a bending sensor 9 and the cross-section morphological features of the expandable balloon 6 outside the flexible rear end 2 measured by a test electrode 10.

The image denoising method comprises the steps of taking a folding line of an internal anal sphincter as a reference characteristic, taking a curve edge characteristic when the anus is lifted and the force is discharged as a movement boundary, then carrying out characteristic matching on each frame of image, carrying out block processing according to a curve folding mode, drawing a change curve of the size of a block along with time and a gray projection change curve of each edge curve after block division is completed, and finally carrying out comprehensive analysis on the change frequency of the size of the block and the curve movement characteristic under different stimulation conditions and functional indexes such as pressure, form, angle and the like at corresponding moments to realize pathological physiological abnormality prediction and evaluation of physiological movement abnormality such as sphincter cramps, tremors and the like.

Further, the image blocking is that the image is divided into different small blocks according to different stress conditions of sphincter muscles, and a gradient operator Roberts of the intersection difference of the edge pixel points relative to other pixel points is calculated in the Gray image by searching the image color at the edge and the foreground color of the image as a judging condition:

Where s _x (i, j) is the pixel horizontal direction filtered value, and s _y (i, j) is the pixel vertical direction filtered value.

Further, the variation intensity is quantized as:

Firstly, modeling and fitting edge lines (folding lines) among all the blocks by adopting a least square fitting curve to obtain an approximate fitting curve, measuring the precision of a curve fitting model by adopting a mean square error MSE (delta), comparing the mean square errors of fitting equations, wherein the MSE (delta) is the smallest, namely the best curve fitting equation:

Y_n*1＝Xβ_n*n*1+ε_n*1+Δ_n*1,D＝σ²I

x, Y is the longitudinal and transverse coordinates of a fitting curve, beta is the parameter of the fitting curve, epsilon is the fitting model error, delta is the accidental error of fitting data Y, E (delta) = 0;n is the number of observations of the fitting curve, t is the number of parameters of the fitting curve, sigma ² is the variance of the observation data, and I is an identity matrix;

Then, the area of each image block is calculated by utilizing an approximation equation of the folding line obtained by modeling through a calculus theorem, so that a curve of the area size of the image block which is related subsequently and is changed along with time and a gray projection change curve of each edge curve are analyzed, and the obtained indexes comprise the change speed (or frequency) and the peak value of the size of each image block, the dithering frequency and the peak value of the edge (the folding line included) and the like.

Further, the decision fusion comprises two parts of parameter set expansion and data fusion;

the parameter set expansion uses two modes of fractal dimension and singular entropy, namely a fractal dimension calculation method:

Where ε is the length of one side of the small cube, N (ε) is the number of features to be measured covered with this small cube, and the dimension formula implies that the dimensions of the feature are determined by covering the feature to be measured with a small cube of side length ε;

The singular entropy calculation method comprises the steps of decomposing a characteristic signal by adopting an EMD algorithm to obtain n IMF components, c ₁,c₂,...c_n to form an initial characteristic vector matrix A, decomposing singular values of A to obtain singular values delta ₁,δ₂,...δ_n, and normalizing each component:

Calculating singular value entropy according to an information entropy formula:

the data fusion is performed by first fusing a model X=F (theta ₁,θ₂,…,θ_j,X_i) by a shared space high-level semantic data,

Wherein, F (·) is a 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= { θ ₁,θ₂,…,θ_j } is learned by gradient update;

Then using the optimal mapping function to express the high-level semantic of the input features, and finally using the joint probability distribution of Bayes network

And combining the associated probability distribution of single Bayes reasoning into a combined posterior probability distribution function, and finally realizing abnormal analysis of anorectal sphincter motor and nerve reflection function by utilizing a decision classifier by taking the likelihood function of the combined distribution function as the minimum.

A method for applying the multi-mode anorectal detection speculum probe is characterized in that the multi-mode anorectal detection speculum probe is used for multi-mode stimulation of anorectal parts, stimulation electric signals act on internal anal sphincter muscles through electric stimulation electrodes 17 to complete electric stimulation, gas or/and liquid acts on internal anal sphincter muscles through the opening of the stimulation tube 23, physical and biochemical stimulation is completed through adjusting physical and biochemical characteristics and injection modes of the gas or/and liquid, an expandable saccule 24 is used for injecting ionic solution into the rectum and sigmoid colon parts through the injection tube 24 to achieve expansion, and the temperature and the volume of the injected solution are changed to perform mechanical and temperature stimulation on intestinal tracts.

The probe is used for evaluating the anorectal sphincter motor and nerve reflex function, when anorectal is stimulated differently, the endoscope module 3 collects moving images of the internal anal sphincter, the front end sensor module 4 detects the pressure at the tail end of the rectum, the pressure measuring hole 13 on the multi-cavity tube 11 detects the pressure of the anal canal, the middle sensor module 7 detects the intestinal canal pressure borne by the expandable saccule 6, the rear end sensor module 8 detects the intestinal canal propelling force borne by the rear end of the probe, the gesture sensors and/or the bending sensors 9 in the front end sensor module 4 and the rear end sensor module 8 detect right angle change of the anus, the plurality of test electrodes 10 distributed on the surface of the flexible rear end 2 detect the shape of the intestinal canal, and functional indexes such as pressure, shape, angle and the like are comprehensively analyzed with the moving images, so that the evaluation of the anorectal sphincter motor and nerve reflex function is realized.

The invention has complete detection functions in biochemistry and imaging, and meets the functional requirements of diagnosis of organic lesions and perception functions. The anorectal sensing function and the sphincter function are diagnosed by collecting the anorectal mechanical function characteristics and the sphincter movement characteristics under different physiological actions, mechanical, biochemical stimulation and electric stimulation conditions for comparison analysis, the sphincter folding line is taken as the identification characteristic, the physiological movements such as sphincter spasm and flutter in the anus are detected through image comparison for carrying out abnormal analysis, the image and the biomechanical information are combined, and the correlation between anorectal organic lesions and functional lesions is detected. The defects of the functional detection technology in the aspects of organic lesion and perception function diagnosis lack of effective nerve and image function evaluation are overcome by introducing the stimulation modes and the motion image acquisition functions of multiple modes.

Referring to fig. 7, an internal anal sphincter fold line identification and movement diagram is shown in an embodiment. The multi-mode anorectal detection speculum probe is used for detecting the camera image and can be used for directly diagnosing internal rectal varicose veins (internal hemorrhoids) and internal anal sphincter folds. The collection of multiple physiological function parameters under multi-modal stimulation can effectively evaluate the influence of the organic lesions on the defecation function. The main evaluation criteria include cooperativity, anal canal opening 85 condition (including opening size, sphincter cooperativity, etc.), compliance (obtained by combining mechanical and geometrical parameters). In the internal anal sphincter exercise collection and comparison, firstly, the internal anal sphincter fold line 87 is identified as a characteristic curve, the characteristics of the levator ani and the force discharge are taken as exercise boundaries, then, continuous images are subjected to characteristic matching, image blocking processing is carried out along the curve, after the blocking is finished, curves of the sizes of the blocks (93 and 94) along with time and gray projection change curves of the edge curves are drawn, and finally, physiological exercise anomalies such as sphincter cramps, flutter and the like are reflected by the abnormal sizes of the blocks and the characteristic of the movement of the curves.

The detection result is used for comparing and analyzing anorectal mechanical function characteristics and sphincter morphology characteristics under different physiological actions, mechanical and biochemical stimulation conditions, can be used for detecting anorectal perception and tolerance capacity, can be used for cooperative diagnosis of pelvic floor anorectal by combining mechanical and morphological data, can clearly identify abnormal conditions such as anorectal polyps and bleeding through an endoscopic image, and can well detect the influence of polyps on defecation functions.

In addition to the stimulation modes which can be realized by the probe, the probe can also be combined with external additional stimulation modes such as peripheral skin nerve touch stimulation (perineum touch), transcranial magnetic stimulation, spinal nerve stimulation and the like.

Here, the outer diameter of the multi-lumen catheter itself may be used as a scale in image analysis (i.e., the outer diameter of the catheter is known, and geometric information of the peripheral image is obtained by a proportional relationship). With the aid of the camera, the structure can be better positioned in the process of placing the probe compared with the existing functional probe. The probe can be placed at various distances from the anal canal, i.e. in some views it can be focused on the lower part of the rectum, but also on the uppermost part of the anal sphincter (the position close to the right angle of the anus, here the important physiological part of the puborectalis muscle 34 hanging down the rectum), where any lateral movement of the probe captured by the camera can be used as an indicator of puborectalis muscle relaxation/contraction.

The probe simulates the design and manufacture of the real intestinal contents, can respectively perform multi-mode stimulation on rectum and internal anal sphincter, collect physiological phenotype characteristics such as pressure, strain characteristics, right angle of anus, sphincter moving images and the like of the anus and rectum corresponding to various stimulation, and realize evaluation on sphincter movement and nerve reflex functions through sphincter movement collection and comparison, and can be used for anorectal disease diagnosis, pharmacological analysis of medicines and the like.

Finally, it should be noted that the above embodiments are only for illustrating the technical solution of the present invention and not for limiting the technical solution, and those skilled in the art should understand that modifications and equivalents may be made to the technical solution of the present invention without departing from the spirit and scope of the present invention, and all such modifications and equivalents are included in the scope of the claims.

Claims

1. A multi-modal anorectal detection endoscope probe, characterized in that it is composed of 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 terminal rectal pressure, 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; edge information extraction; feature matching; image segmentation; 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 +ε _n*1 +Δ _n*1 , D=σ ² I

X, 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 variance of the observed data; 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 the EMD algorithm to decompose the characteristic signal to obtain n IMF components, c ₁ , c ₂ , ... c _n , to form the initial eigenvector matrix A, perform singular value decomposition on A to obtain singular values δ ₁ , δ ₂ , ...δ _n , and normalize each component:

Calculate the singular value entropy according to the information entropy formula:

The data fusion is first performed through a shared spatial high-level semantic data fusion model X=F(θ ₁ ,θ ₂ ,L,θ _j ,X _i ),

Where F(·) is the feature mapping function learned by the neural network, _Xi represents the output of the neural network, and X represents the high-level semantic features of the neural network. The optimal parameter set θ = {θ ₁ , θ ₂ , …, θ _j } is learned by gradient updating;

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. According to the multimodal anorectal detection endoscope probe of claim 1, it is characterized in that the front-end sensor module (4), the middle sensor module (7) and the rear-end sensor module (8) respectively contain multiple sensors such as pressure, temperature, posture, etc. and/or single-chip microcomputers.

3. According to claim 1, the multimodal anorectal detection endoscope probe is characterized in that the multi-lumen tube (11) has a plurality of cavities, wherein the first cavity (52) is connected to the stimulation tube (23), the second cavity (51) is connected to the irrigation tube (24), and the third or multiple cavities (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. According to claim 1, the multimodal anorectal detection endoscope probe is characterized in that the fastener (19) has a plurality of front-to-back through-channels, through which the colloid can flow into the groove on the outer shell of the rigid front end (1) during the injection molding process, and after the colloid is solidified, it can be tightly connected to the flexible rear end (2) as a whole, thereby ensuring the connection stability of the front and rear structures of the probe.

5. The multimodal anorectal detection endoscope probe according to claim 3 is 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. According to the multimodal anorectal detection endoscope probe of claim 1, it is characterized in that 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 curves during anal levation and force displacement 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, morphology 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.

7. The multimodal anorectal detection endoscope probe according to claim 1 is characterized in that the image is divided into different small blocks according to different sphincter stress conditions, and the image color at the edge and the foreground color of the picture are retrieved, and the gradient operator Roberts of the cross difference of the edge pixel points relative to other pixel points is calculated in the Gray grayscale image as the judgment condition:

Wherein, s _x (i, j) is the horizontal filtering value of the pixel, and _sy (i, j) is the vertical filtering value of the pixel.

8. An application method of a multimodal anorectal detection endoscope probe, characterized in that the multimodal anorectal detection endoscope probe described in any one of claims 1 to 7 is used for multimodal stimulation of the anorectal area, the stimulation electric signal acts on the internal anal sphincter through the electric stimulation electrode (17) to complete the electric 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 (6) is injected into the rectum and sigmoid colon through the perfusion tube (24) to achieve expansion, and the intestine is mechanically and thermally stimulated 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.