Extensible air bag type anorectal function evaluation probe

Abstract

The invention discloses an extendable air bag type anorectal function evaluation probe, which comprises an expandable support layer, an air bag and a probe body, the adhesive layer is arranged between the outer surface of the expandable support layer and the substrate layer and is used for connecting the two; the substrate layer is attached to the surface of the adhesion layer; the flexible electrode array film layer is attached to the surface of the substrate layer; the outer insulating film layer covers the surface of the flexible electrode array film layer, and electrodes in the flexible electrode array film layer are exposed in the air through electrode holes of the outer insulating film layer; and the pipeline is connected with the cavity formed by the expandable supporting layer through the input port. The probe expands after being filled with gas or liquid through a pipeline, and can adapt to huge volume change before and after being put into the anus, so that the comfort of a testee is improved, and comprehensive and accurate evaluation on functions of anorectal muscle groups can be realized.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to an expandable airbag-type anorectal function assessment probe. Background Art

[0002] The anorectum is an important organ of the human body, and the importance of its function examination and disease diagnosis and treatment has been generally recognized by neurologists, orthopedics, urologists, and obstetricians and gynecologists. Anorectal function examination is of great significance in the identification and diagnosis of many diseases. For example, for Parkinson's disease and Parkinson's syndrome, lumbar radiculopathy and cone cauda equina syndrome, unexplained urinary and bowel function and sexual dysfunction, anorectal function examination can help doctors judge the subject's muscle control ability, determine the location and extent of the lesion, etc., and help doctors better diagnose the disease. In addition, for low-position rectal cancer with a high incidence rate, early anorectal function examination is the key to discovering the disease and timely diagnosis and treatment. Therefore, accurate evaluation and diagnosis of anorectal function is of great value.

[0003] Anal sphincter electromyography and pressure testing are important neuroelectrophysiological examination methods in clinical practice. The process is guided by a software program to collect and analyze the surface electromyographic signals and pressure signals of the anorectal muscles when they perform a series of contraction and relaxation instructions within a certain period of time. By analyzing these signals, doctors can evaluate the tension and muscle strength function of the entire anorectal muscle group and detect abnormalities.

[0004] Traditional anorectal muscle function assessment mostly uses a rigid anorectal probe to collect surface electromyographic signals and pressure signals. However, due to the particularity of the anorectal morphology, the use of a rigid anorectal probe may result in some adverse consequences during the collection process, mainly manifested as:

[0005] (1) The existing anorectal function assessment probes have poor bioadaptability. Since the muscle function morphology of each subject is different and the extensibility of the anorectum is more than 300%, fixed-shape probes can only match anorectal environments of a specific size and cannot adapt to the volume changes caused by anorectal contraction, which may affect the natural movement of the anorectum and fail to achieve effective fit between the probe and the muscle, thus reducing the accuracy of the assessment.

[0006] (2) The signal quality measured by the existing anorectal function assessment probe is low. During the assessment process, the tester can easily push the probe of a specific size out of the rectum. When the electrode and the human body are relatively displaced, motion artifact interference signals with amplitudes far higher than the electromyographic signal are generated, affecting the accuracy of the signal and subsequent diagnosis.

[0007] (3) The test subject has a poor user experience. Existing hard probes are generally cylindrical, with a diameter ranging from 1 cm to 3 cm. When the probe is inserted into the anus, it may cause pressure or irritation to the anorectal wall, which can easily cause discomfort, foreign body sensation or pain to the test subject.

[0008] Therefore, how to design an anorectal function assessment probe that can balance high-quality bioadaptability, measurement accuracy, and comfort of use has become an urgent problem to be solved. Summary of the invention

[0009] In view of the above, the object of the present invention is to provide an expandable airbag-type anorectal function assessment probe, which can deform to adapt to different volume environments, can collect multi-channel surface electromyography data, air pressure data and transmit signals, and at the same time has high-quality bioadaptability, measurement accuracy and comfort of use.

[0010] In order to achieve the above-mentioned invention object, the technical solution provided by the present invention is as follows:

[0011] An embodiment of the present invention provides an expandable airbag-type anorectal function assessment probe, comprising:

[0012] an expandable support layer, which forms a cavity with an input port, and is inflated by filling gas or liquid through the input port;

[0013] an adhesive layer, which is interposed between the outer surface of the expandable support layer and the substrate layer and is used to connect the two;

[0014] A substrate layer, which is attached to the surface of the adhesive layer and serves as a carrier of the flexible electrode array thin film layer;

[0015] A flexible electrode array film layer is attached to the surface of the substrate layer, and the extended wires in the flexible electrode array film layer are gathered and led out from the output port;

[0016] An outer insulating film layer covers the surface of the flexible electrode array film layer, and the outer insulating film layer is provided with electrode holes, through which the electrodes in the flexible electrode array film layer are exposed to the air;

[0017] a conduit connected to the cavity formed by the expandable support layer through an input port;

[0018] The expandable support layer, adhesion layer, substrate layer, flexible electrode array film layer and outer insulating film layer are all ductile. After gas or liquid is filled into the pipeline, the volume of the expandable support layer increases, and the integrated structure composed of the adhesion layer, substrate layer, flexible electrode array film layer and outer insulating film layer simultaneously changes the corresponding structure to adapt to the volume change of the expandable support layer, and finally forms a rugby-shaped or spherical probe.

[0019] Preferably, the probe is divided into an unexpanded initial form and an expanded extended form, and the volume of the extended form is up to 600% of the volume of the initial form while maintaining conduction. By changing the size of the overall probe, it can adapt to the physiological environment with a huge volume difference before and after being placed in the human body, ensuring comfort while maintaining measurement accuracy.

[0020] Preferably, the integrated structure exists in a flat origami form before expansion, and unfolds after expansion, and can achieve an elongation deformation of 0 to 600% along the longitudinal direction of the pipeline and an elongation deformation of 0 to 500% in various directions relative to the lateral direction of the pipeline. The adhesion layer, substrate layer, flexible electrode array film layer and outer insulating film layer in the integrated structure always maintain the same form during use, so that a huge morphological difference is formed in the overall shape of the probe before and after expansion, while maintaining the integrity of the electrode structure and the original electrical performance of the probe.

[0021] Preferably, the integrated structure is distributed in a manner of evenly distributing a plurality of structures on the outer surface of the expandable support layer along the circumferential direction of the pipe, and each structure is divided into a plurality of folds, which are folded according to the folds, so that the adhesion layer, substrate layer, flexible electrode array film layer and outer insulating film layer in each structure are all in a multi-layer folded fish-scale flat origami shape when not expanded, so as to ensure that the probe will not cause damage to the human body when entering and exiting the human body, thereby reducing discomfort.

[0022] Preferably, the flexible electrode array film layer is divided into multiple electrode films according to the evenly distributed multi-piece structure, each electrode film contains 4 to 200 electrodes, each electrode has a radius of 1 mm to 5 mm, and the distance between the electrodes along the longitudinal direction of the pipeline is 3 mm to 10 mm. The electrodes are used to collect electromyographic data and air pressure data, thereby realizing multi-channel electromyographic and air pressure multimodal acquisition functions and completing synchronous evaluation and diagnosis at different angles.

[0023] Preferably, the extended wires are gathered and led out from the output port and connected to an adapter board, so that the wires do not come into direct contact with the human body and are led out from the output port as a whole. The adapter board is a printed circuit board or a flexible circuit board, and the interface of the adapter board is a shielded DuPont line port or other interfaces with shielding function integrated with the acquisition equipment, thereby shielding external interference.

[0024] Preferably, the expandable support layer is a ductile material with a thickness of 20 μm to 3 mm, and the ductile material includes polydimethylsiloxane or a linear triblock copolymer.

[0025] Preferably, the substrate layer and the outer insulating film layer are respectively made of ductile materials with a thickness of 30 μm to 500 μm, and the ductile materials include polydimethylsiloxane, linear triblock copolymer or polylactic acid.

[0026] Preferably, the material of the flexible electrode array film layer includes copper, gold, silver, silver chloride or conductive carbon, and has a certain ductility. The thickness of the extension wire gathering part of the output port of the flexible electrode array film layer is 1 μm to 300 μm.

[0027] Preferably, the adhesive layer comprises 1 to 5 layers of at least one ductile adhesive with gradually increasing Young's modulus, and the ductile adhesive comprises polyvinyl alcohol, polyhydroxyethyl acrylate and / or polyacrylamide, so as to ensure that the electrode array morphology of the flexible electrode array film layer is stable under 0 to 600% extension.

[0028] Preferably, the expandable support layer, substrate layer, flexible electrode array film layer, adhesive layer and outer insulating film layer are a smooth integrated structure and will not cause damage to the human body.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] (1) Traditional anorectal assessment probes are hard probes and cannot change shape. The extensible flexible electrode designed in the present invention can be stretched in multiple directions. Combined with the inner layer of gas or liquid support design, it can change the overall volume to adapt to the huge volume change before and after insertion into the human body, thereby improving the comfort of the subject while maintaining the accuracy of the measurement.

[0031] (2) The electrode array distributed on the probe adopts a flexible film form, which can improve biocompatibility while maintaining close contact with the skin during the evaluation process, thereby increasing the contact area with the skin, reducing the electrode-skin contact impedance, and enhancing signal accuracy.

[0032] (3) The traditional anorectal probe is a few channels + surface electrodes, while the present invention adopts a multi-channel surface flexible electrode array (4 to 200 channels) to increase the accuracy of specific muscle group research and accurately locate the lesion.

[0033] (4) Through the multiplexing of surface electromyography and air pressure acquisition, a comprehensive evaluation of muscle function can be achieved, and the evaluation and diagnosis results are more accurate. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0035] Figure 1 It is a schematic diagram of the structure of an airbag type anorectal function assessment probe provided by an embodiment of the present invention;

[0036] Figure 2 is a schematic diagram of a stepped structure of the Young's modulus of the adhesion layer provided by an embodiment of the present invention;

[0037] Figure 3 is a schematic diagram of the distribution of electrode array sites provided by an embodiment of the present invention;

[0038] Figure 4 is a schematic diagram comparing the morphology of the integrated structure before and after extension provided by an embodiment of the present invention;

[0039] Figure 5 : is a schematic diagram comparing the physical extension form of the airbag type anorectal function assessment probe provided by an embodiment of the present invention;

[0040] Figure 6 This is an electromyographic signal diagram measured by the airbag type anorectal function assessment probe provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0041] To make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific implementation methods described herein are only used to explain the present invention and do not limit the scope of protection of the present invention.

[0042] The inventive concept of the present invention is: in view of the problem that the rigid anorectal probes used in the prior art cannot take into account high-quality biocompatibility, measurement accuracy and comfort of use during the collection process, the embodiments of the present invention provide an expandable airbag-type anorectal function assessment probe, the probe can be stretched in multiple directions, and the special origami structure design of the expandable support layer and the flexible electrode array film layer can be used to change the overall probe size. When inserted, the probe is in an unexpanded initial form, and after insertion, the probe is controlled to expand into an extended form. The electromyographic signals and air pressure signals are collected through multi-channel electrodes, which can ensure comfort and maintain measurement accuracy on the basis of high-quality biocompatibility, and realize synchronous evaluation and diagnosis of anorectal function at different angles.

[0043] Figure 1 Schematic diagram of the structure of the airbag anorectal function assessment probe provided by the embodiment of the present invention. Figure 1 As shown, the embodiment provides an expandable airbag type anorectal function assessment probe, comprising: an outer insulating film layer 1, a flexible electrode array film layer 2, a substrate layer 3, an adhesion layer 4, an expandable support layer 5 and a pipe 6.

[0044] The expandable support layer 5 is a ductile material including polydimethylsiloxane (PDMS), linear three-block copolymer (SEBS), silicone or rubber, and has a thickness of 0.5 mm. Figure 1As shown, the expandable support layer 5 forms a cylindrical cavity with an input port in the initial form, and the input port is connected to the pipe 6. The diameter of the cylindrical cavity is 10 mm, which is used to maintain the shape of the entire probe. The two ends of the cylindrical cavity of the expandable support layer 5 are fixed, and the two ends do not expand when in use. The middle section of the cylindrical cavity does not expand in the initial form. The pipe 6 is used to fill the gas or liquid from the input port to the middle section of the cylindrical cavity of the expandable support layer 5 to expand and form a rugby-shaped or spherical ball. The maximum diameter of the ball in the direction perpendicular to the pipe 6 is 3 cm.

[0045] The adhesive layer 4 is interposed between the expandable support layer 5 and the substrate layer 3 to connect the two. Figure 2 As shown, the adhesion layer 4 is obtained by integrating polydimethylsiloxane with different ratios in multiple times, and is divided into 5 layers, each layer is 10 μm thick, and the Young's modulus increases step by step from bottom (the side close to the expandable support layer 5) to top (the side close to the substrate layer 3). This special gradual structure can buffer the tangential force and normal force energy brought by the change in the surface area of ​​the expandable support layer 5 when filled with gas or liquid, thereby maintaining the stability of the electrical performance of the circuit on the flexible electrode array film layer 2.

[0046] The substrate layer 3 is attached to the surface of the adhesive layer 4 and serves as a carrier of the flexible electrode array film layer 2, and is used to fix the electrode array and protect the electrode shape so that it is not easy to fail when extended. The substrate layer 3 is a ductile material including polydimethylsiloxane, linear triblock copolymer or polylactic acid, and has a thickness of 50 μm.

[0047] like Figure 3 As shown, the flexible electrode array film layer 2 includes 6 electrode films, each of which contains a collection electrode unit, forming a 6-channel electrode array. Among them, the 4 electrode units close to the pipe 6 form a dense electrode array, which collects data through contact electrodes, and the electrode units form measurement units. Each measurement unit is used to collect data above the anal sphincter, below the anal sphincter, and on the left / right side of the anal sphincter. The 2 electrode units far away from the pipe 6 form a sparse electrode array, which is used to collect data on the left / right side of the phalangeal rectus muscle. Such an array arrangement can accurately divide the superficial muscles and deep muscles, and then accurately measure the electromyographic signals of different muscle groups, increase the accuracy of the study of specific muscle groups, and accurately locate the lesions.

[0048] The internal lead of each electrode film adopts a serpentine routing form that combines a circular ring and a straight line, where the circular ring is 270°, which is the angle with the highest extension and deformation stability among various angles.

[0049] The thickness of the flexible electrode array film layer 2 is 50 μm, and the thickness of the output port extension wire gathering part is 20 μm. The material of the flexible electrode array film layer 2 includes copper, gold, silver, silver chloride or conductive carbon, wherein the material of the circular head of the electrode in contact with the human body is solidified conductive silver paste.

[0050] The outer insulating film layer 1 is used as a protective layer, covering the surface of the flexible electrode array film layer 2. The outer insulating film layer 1 is provided with electrode holes. The electrode parts in the flexible electrode array film layer 2 are exposed to the air through the electrode holes and directly contact the human body when inserted into the human body. The outer insulating film layer 1 is a ductile material including polydimethylsiloxane, a linear triblock copolymer or polylactic acid, and has a thickness of 35 μm.

[0051] like Figure 4 As shown, in the initial form without gas or liquid, the integrated structure composed of the adhesive layer 4, the substrate layer 3, the flexible electrode array film layer 2 and the outer insulating film layer 1 reserves an out-of-plane extension space through a multi-layer folding form to adapt to a small volume. Such a special structure, combined with the 50μm thickness and low Young's modulus of the flexible electrode array film layer 2, prevents the origami from warping out of the plane, but can yield to the stress in a certain direction and fall down layer by layer, finally forming a fish scale-like structure to improve the comfort when entering the human body. When used, the input port of the expandable support layer 5 is connected to the pipe 6 with a circular hole. After the gas or liquid is filled into the pipe 6, the expandable support layer 5 expands. Affected by the increase in the internal volume of the expandable support layer 5, the two ends of the folding space are fixed, and the middle part is gradually released. The integrated structure composed of the adhesive layer 4, the substrate layer 3, the flexible electrode array film layer 2 and the outer insulating film layer 1 expands together. Finally, the film of the integrated structure is completely flattened to form a rugby-shaped probe. At this time, the electrode array is in full contact with the muscle, and the stability of the contact between the skin and the electrode is increased under the action of the internal pressure, thereby improving the accuracy of the signal. After the inflation or liquid filling is completed, the pipeline 6 can be closed to maintain the complete sealing of the inner layer, and the supporting effect can be achieved through air pressure or water pressure.

[0052] like Figure 5As shown, when used, the probe is extended into the anorectum from outside the body in the unexpanded initial form on the left side of the figure. After being placed in the body, it is filled with gas or liquid to expand. The expanded probe is shown on the right side of the figure. The expansion rate is set according to the doctor's diagnosis and treatment needs to detect the anorectal muscle group. The traditional anorectal assessment probe is a fixed hard probe that cannot change its shape. The probe designed by the present invention can achieve multi-directional stretching through expansion, and the inner layer inflation / liquid support design can flexibly change the overall volume to adapt to the huge volume change before and after being placed in the anus. Before the probe is placed in the human body, the cylindrical diameter of the probe is only 10mm, which is only 1 / 3 of the traditional anorectal probe, thereby reducing the discomfort of the subject. During the test, the 6-channel electrode array on the flexible electrode array film layer 2 is connected to the measurement surface electromyographic signal and air pressure signal through differential input.

[0053] In order to facilitate external connection, the electrodes at the lower end of the flexible electrode array film layer 2 are extended with wires, which are gathered and then led out from the output port to be connected to the adapter board. Specifically, the tail of the extensible flexible electrode array film layer 2 is connected to the external circuit using a zero plug-in force FPC connector, and after the transfer, the shielded related interface is connected to the signal acquisition part. Pipeline 6 is connected to the air pressure sensor module of the acquisition equipment, which can synchronously collect air pressure signals during the electromyography detection process, thereby achieving a comprehensive evaluation of muscle group functions, and the evaluation and diagnosis results are more accurate.

[0054] like Figure 6 As shown, the electromyographic images of the external anal sphincter site 1 and the pubococcygeus muscle site 2 measured by the expandable balloon-type anorectal function assessment probe are similar in shape but different in size, indicating that the probe can accurately detect different muscle health abnormalities in adjacent areas and significantly distinguish them.

[0055] In summary, a stretchable airbag anorectal function assessment probe can maintain the stability of the probe structure while changing the overall probe size by designing the expandability of the expandable support layer, the special origami structure design of the flexible electrode array film layer, and the gradual energy buffering design of the adhesion layer. It can adapt to the physiological environment with a huge volume difference before and after being placed in the human body, ensuring comfort while maintaining measurement accuracy. In addition, it can be flexibly expanded to different expansion versions through the design of different sites and the change of film size. In the present invention, the probe has both multi-channel electromyography and air pressure multi-modal acquisition functions, which can realize synchronous evaluation and diagnosis at different angles.

[0056] The specific implementation methods described above provide a detailed description of the technical solutions and beneficial effects of the present invention. It should be understood that the above is only the most preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, supplements and equivalent substitutions made within the scope of the principles of the present invention should be included in the protection scope of the present invention.

Claims

1. An expandable balloon-type anorectal function assessment probe, characterized in that: include: an expandable support layer, which forms a cavity with an input port, and is inflated by filling gas or liquid through the input port; an adhesive layer, which is interposed between the outer surface of the expandable support layer and the substrate layer and is used to connect the two; A substrate layer, which is attached to the surface of the adhesive layer and serves as a carrier of the flexible electrode array thin film layer; A flexible electrode array film layer is attached to the surface of the substrate layer, and the extended wires in the flexible electrode array film layer are gathered and led out from the output port; An outer insulating film layer covers the surface of the flexible electrode array film layer, and the outer insulating film layer is provided with electrode holes, through which the electrodes in the flexible electrode array film layer are exposed to the air; a conduit connected to the cavity formed by the expandable support layer through an input port; The expandable support layer, adhesion layer, substrate layer, flexible electrode array film layer and outer insulating film layer are all ductile. After gas or liquid is filled into the pipeline, the volume of the expandable support layer increases, and the integrated structure composed of the adhesion layer, substrate layer, flexible electrode array film layer and outer insulating film layer simultaneously changes the corresponding structure to adapt to the volume change of the expandable support layer, and finally forms a rugby-shaped or spherical probe.

2. The expandable air-bag anorectal function assessment probe according to claim 1, characterized in that: The probe is divided into an unexpanded initial form and an expanded extended form, and the volume of the extended form is up to 600% of the volume of the initial form.

3. The expandable air-bag type anorectal function assessment probe according to claim 1, characterized in that: The integrated structure exists in a flat origami form before expansion and unfolds after expansion, and can achieve an extension deformation of 0 to 600% along the longitudinal direction of the pipeline and a deformation of 0 to 500% relative to the transverse direction of the pipeline. The adhesion layer, substrate layer, flexible electrode array film layer and outer insulating film layer in the integrated structure always maintain the same form when in use.

4. The expandable air-bag type anorectal function assessment probe according to claim 1 or 3, characterized in that: The integrated structure is distributed in a manner that multiple pieces are evenly distributed along the circumferential direction of the pipe on the outer surface of the expandable support layer, and each piece of the structure is divided into multiple folds, which are folded according to the folds, so that the adhesion layer, substrate layer, flexible electrode array film layer and outer insulating film layer in each piece of the structure are all in a flat origami shape with multiple layers of folded arrangement when not expanded.

5. The expandable air-bag anorectal function assessment probe according to claim 4, characterized in that: According to the evenly distributed multi-piece structure, the flexible electrode array film layer is divided into multiple electrode films. Each electrode film contains 4 to 200 electrodes. The radius of each electrode is 1 mm to 5 mm. The distance between the electrodes along the longitudinal direction of the pipeline is 3 mm to 10 mm. The electromyographic data and air pressure data are collected through the electrodes.

6. The expandable air-bag anorectal function assessment probe according to claim 1, characterized in that: The extended wires are gathered and led out from the output port to be connected to the adapter board, which is a printed circuit board or a flexible circuit board. The interface of the adapter board is a shielded DuPont line port or other interfaces with shielding function integrated with the acquisition equipment.

7. The expandable air-bag anorectal function assessment probe according to claim 1, characterized in that: The expandable support layer is a ductile material with a thickness of 20 μm to 3 mm, and the ductile material includes polydimethylsiloxane or a linear tri-embedded copolymer.

8. The expandable air-bag anorectal function assessment probe according to claim 1, characterized in that: The substrate layer and the outer insulating film layer are respectively made of ductile materials with a thickness of 30 μm to 500 μm, and the ductile materials include polydimethylsiloxane, linear tri-embedded copolymer or polylactic acid.

9. The expandable air-bag anorectal function assessment probe according to claim 1, characterized in that: The material of the flexible electrode array film layer includes copper, gold, silver, silver chloride or conductive carbon, and the thickness of the extension wire gathering part of the output port of the flexible electrode array film layer is 1 μm to 300 μm.

10. The expandable air-bag anorectal function assessment probe according to claim 1, characterized in that: The adhesive layer comprises 1 to 5 layers of at least one extensible adhesive with gradually increasing Young's modulus, and the extensible adhesive comprises polyvinyl alcohol, polyhydroxyethyl acrylate and / or polyacrylamide.

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