A malleable airbag-type anorectal function evaluation probe

Abstract

The present invention discloses a stretchable airbag-type anorectal function evaluation probe, comprising: an inflatable support layer that is inflated by filling with gas or liquid; an adhesion layer that is interposed between the outer surface of the inflatable support layer and the substrate layer and is used to connect the two; a substrate layer that is attached to the surface of the adhesion layer; a flexible electrode array thin film layer that is attached to the surface of the substrate layer; an outer insulating thin film layer that covers the surface of the flexible electrode array thin film layer, and the electrodes in the flexible electrode array thin film layer are exposed to the air through the electrode holes of the outer insulating thin film layer; a pipeline that is connected to the cavity formed by the inflatable support layer through an input port. After the probe is inflated by filling with gas or liquid through the pipeline, it can adapt to the huge volume change before and after being inserted into the anus, improve the comfort of the subject, and can comprehensively and accurately evaluate the functions of the anorectal muscle groups.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a stretchable balloon-type anorectal function evaluation 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, orthopedists, urologists, and obstetricians and gynecologists. Anorectal function examination is of great significance in the differentiation and diagnosis of many diseases. For example, for diseases such as Parkinson's disease and Parkinson's syndrome, lumbar radiculopathy and conus medullaris and cauda equina syndrome, and unexplained urinary and fecal function and sexual dysfunction, anorectal function examination can help doctors judge the muscle control ability of the subject, determine the location and degree of the lesion, etc., and help doctors better diagnose the condition. In addition, for low rectal cancer with a relatively high incidence rate, early anorectal function examination is the key to detecting the disease and timely diagnosis and treatment. Therefore, accurate evaluation and diagnosis of anorectal function have important value.

[0003] Anorectal sphincter electromyogram examination and pressure detection are important neuroelectrophysiological examination methods in clinical practice. The process is guided by a software program, and the surface electromyogram signals and pressure signals of the anorectal muscle group are collected and analyzed within a certain time when the anorectal muscle group performs a series of contraction and relaxation instructions. Through the analysis of these signals, doctors can evaluate the tension and muscle strength functions of the entire anorectal muscle group and screen for abnormalities.

[0004] Most traditional anorectal muscle function evaluations use rigid anorectal probes to collect surface electromyogram signals and pressure signals. However, due to the special shape of the anorectum, some adverse consequences will occur during the collection process when using rigid anorectal probes, mainly manifested as:

[0005] (1) The existing anorectal function evaluation probes have poor biocompatibility. Since the muscle function morphology of each subject is different, and the stretchability of the anorectum is more than 300%, probes with a fixed shape can only match a specific size of the anorectal environment and cannot adapt to the volume change caused by anorectal contraction, which may affect the natural movement of the anorectum and cannot achieve effective fitting between the probe and the muscle, thus leading to a decrease in the accuracy of the evaluation.

[0006] (2) The signal quality measured by the existing anorectal function evaluation probes is low. During the evaluation process, the tester is very likely to push out the probe of a specific size from the rectum. When there is a relative displacement between the electrode and the human body, motion artifact interference signals with amplitudes much higher than the electromyogram signals will be generated, affecting the accuracy of the signals and subsequent diagnosis.

[0007] (3) The user experience of the subject being tested is poor. Existing rigid probes are generally cylindrical, with diameters ranging from 1 cm to 3 cm. During the process of inserting the probe into the anus, it may cause pressure or irritation to the anorectal wall, easily leading to discomfort, a foreign body sensation, or pain in the subject being tested.

[0008] Therefore, how to design an anorectal function evaluation probe that can balance excellent biological adaptability, measurement accuracy, and usage comfort 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 a deployable airbag-type anorectal function evaluation probe, which can deform to adapt to different volume environments, can collect multi-channel surface electromyography data and air pressure data and transmit signals, and at the same time has excellent biological adaptability, measurement accuracy, and usage comfort.

[0010] To achieve the above object of the invention, the technical solution provided by the present invention is as follows:

[0011] A deployable airbag-type anorectal function evaluation probe provided by an embodiment of the present invention includes:

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

[0013] An adhesion layer, which is between the outer surface of the inflatable 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 adhesion layer and serves as a carrier for the flexible electrode array film layer;

[0015] A flexible electrode array film layer, which 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, which covers the surface of the flexible electrode array film layer, and electrode holes are provided on the outer insulating film layer, and the electrodes in the flexible electrode array film layer are exposed to the air through the electrode holes;

[0017] A pipeline, which is connected to the cavity formed by the inflatable support layer through the input port;

[0018] The inflatable support layer, the adhesion layer, the substrate layer, the flexible electrode array film layer, and the outer insulating film layer are all extensible. After filling gas or liquid through the pipeline, the volume of the inflatable support layer becomes larger, and the integrated structure composed of the adhesion layer, the substrate layer, the flexible electrode array film layer, and the outer insulating film layer simultaneously changes the corresponding structure to adapt to the volume change of the inflatable support layer, and finally forms a probe in the shape of a rugby ball or a sphere.

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

[0020] Preferably, the integrated structure exists in a flat origami form before expansion and unfolds after expansion, capable of achieving an extension deformation of 0 - 600% along the longitudinal direction of the pipeline and an extension deformation in all directions of 0 - 500% relative to the transverse direction of the pipeline. The adhesive layer, substrate layer, flexible electrode array thin film layer, and outer insulating thin film layer in the integrated structure always maintain the same form during use, resulting in a huge morphological difference in the overall probe before and after expansion, while also maintaining the integrity of the electrode structure and the original electrical performance of the probe.

[0021] Preferably, the distribution method of the integrated structure is to be evenly distributed in multiple pieces along the circumferential direction of the pipeline on the outer surface of the expandable support layer. Each piece of structure is divided into multiple creases and folded according to the creases, so that the adhesive layer, substrate layer, flexible electrode array thin film layer, and outer insulating thin film layer in each piece of structure are all in a multi-layer folded arrangement in a fish-scale-like flat origami form when not expanded, ensuring that the probe will not cause damage to the human body and reducing discomfort during the process of entering and exiting the human body.

[0022] Preferably, the flexible electrode array thin film layer is correspondingly divided into multiple electrode thin films according to the evenly distributed multiple pieces of structure. Each electrode thin film contains 4 - 200 electrodes, the radius of each electrode is 1 mm - 5 mm, and the distance between the electrodes along the longitudinal direction of the pipeline is 3 mm - 10 mm. By collecting electromyogram data and air pressure data through the electrodes, it can achieve the function of multi-channel electromyogram and air pressure multi-modal acquisition, and complete the synchronous evaluation and diagnosis at different angles.

[0023] Preferably, the extended wires are gathered and led out from the output port and connected to the adapter board, so that the wires do not directly contact 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 wire port or other interfaces with shielding functions integrated with the acquisition device, thereby shielding external interference.

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

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

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

[0027] Preferably, the adhesion layer includes at least one kind of extensible adhesive with 1 to 5 layers having gradually increasing Young's modulus. The extensible adhesive includes polyvinyl alcohol, 2-hydroxyethyl acrylate and / or polyacrylamide, so as to ensure the stable morphology of the electrode array of the flexible electrode array thin film layer under 0 to 600% extension.

[0028] Preferably, the inflatable support layer, the substrate layer, the flexible electrode array thin film layer, the adhesion layer and the outer insulating thin film layer are of a smooth integral molding structure, which will not cause damage to the human body.

[0029] Compared with the prior art, the beneficial effects of the present invention at least include:

[0030] (1) The traditional anorectal evaluation probe is a rigid probe and cannot change its shape. The extensible flexible electrode designed by the present invention can be stretched in multiple directions, and the overall volume can be changed by cooperating with the inner layer filled with gas or liquid support design, adapting to the huge volume change before and after being inserted into the human body, improving the comfort of the subject while maintaining the accuracy of measurement.

[0031] (2) The electrode array distributed on the probe adopts a flexible thin film form, which can keep close contact with the skin during the evaluation process while improving biocompatibility, so as to increase the contact area with the skin, reduce the electrode-skin contact impedance and enhance the signal accuracy.

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

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

[0034] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0035] Figure 1 It is a schematic structural diagram of the balloon-type anorectal function evaluation probe provided by the embodiment of the present invention;

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

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

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

[0039] Figure 5 It is a schematic diagram of the morphological comparison of the physical extension of the balloon-type anorectal function evaluation probe provided by an embodiment of the present invention;

[0040] Figure 6 It is an electromyogram measured by the balloon-type anorectal function evaluation probe provided by an embodiment of the present invention. Detailed implementation manners

[0041] To make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific implementation manners described herein are only used to explain the present invention and do not limit the protection scope of the present invention.

[0042] The inventive concept of the present invention is as follows: Aiming at the problem that the existing hard anorectal probe cannot take into account good biological adaptability, measurement accuracy and use comfort during the collection process, an embodiment of the present invention provides a stretchable balloon-type anorectal function evaluation probe. The probe can be stretched in multiple directions, and the special origami structure design of the inflatable support layer and the flexible electrode array film layer is used to change the overall size of the probe. When inserted, the probe is in the unexpanded initial form, and after insertion, the probe is controlled to expand into an extended form. The electromyogram signal and the air pressure signal are collected through the multi-channel electrodes, which can ensure comfort and maintain the accuracy of measurement on the basis of good biological adaptability, and realize the synchronous evaluation and diagnosis of anorectal functions at different angles.

[0043] Figure 1 It is a schematic diagram of the structure of the balloon-type anorectal function evaluation probe provided by an embodiment of the present invention. As Figure 1 shown, the embodiment provides a stretchable balloon-type anorectal function evaluation probe, including: an outer insulating film layer 1, a flexible electrode array film layer 2, a substrate layer 3, an adhesion layer 4, an inflatable support layer 5 and a pipeline 6.

[0044] Among them, the inflatable support layer 5 is a stretchable material including polydimethylsiloxane (PDMS), linear triblock copolymer (SEBS), silica gel or rubber, and the thickness is 0.5 mm. As Figure 1As shown, the inflatable support layer 5 forms a cylindrical cavity with an input port in its initial form. 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. Both ends of the cylindrical cavity of the inflatable support layer 5 are fixed and do not expand during use. The middle section of the cylindrical cavity does not expand in the initial form. Gas or liquid is filled into the cylindrical cavity of the inflatable support layer 5 from the input port through the pipe 6 to make the middle section of the cylindrical cavity expand and form a sphere in the shape of a rugby ball or a round ball. The maximum diameter of the sphere in the direction perpendicular to the pipe 6 is 3 cm.

[0045] The adhesion layer 4 is located between the inflatable support layer 5 and the substrate layer 3 and is used to connect the two. As Figure 2 shown, the adhesion layer 4 is obtained by integrating polydimethylsiloxane with different ratios in multiple times. It is divided into 5 layers, and the thickness of each layer is 10 μm. The Young's modulus increases gradually from the bottom (the side close to the inflatable support layer 5) to the top (the side close to the substrate layer 3). This special gradient structure can buffer the tangential force and normal force energy brought by the change of the surface area of the inflatable support layer 5 when gas or liquid is filled, and then maintain the stability of the electrical performance of the circuits on the flexible electrode array thin film layer 2.

[0046] The substrate layer 3 is attached to the surface of the adhesion layer 4 and serves as the carrier of the flexible electrode array thin film layer 2. It is used to fix the electrode array and protect the electrode form so that it is not easy to fail during extension. The substrate layer 3 is a stretchable material including polydimethylsiloxane, linear triblock copolymer or polylactic acid, and the thickness is 50 μm.

[0047] As Figure 3 shown, the flexible electrode array thin film layer 2 includes 6 electrode thin films. Each electrode thin film contains a collection electrode unit, and together they form a 6-channel electrode array. Among them, 4 electrode units close to the pipe 6 form a dense electrode array, and data is collected through the contact electrodes. The measurement units are formed between the electrode units, and 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 respectively. The 2 electrode units far from the pipe 6 form a sparse electrode array, which is used to collect data on the left / right side of the puborectalis 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 leads of each electrode thin film adopt a serpentine wiring form combining a ring and a straight line, where the ring is 270°, which is the angle with the highest stability of extension deformation among various angles.

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

[0050] The outer insulating thin film layer 1 serves as a protective layer and covers the surface of the flexible electrode array thin film layer 2. Electrode holes are provided on the outer insulating thin film layer 1. The electrode part in the flexible electrode array thin film layer 2 passes through the electrode holes and is exposed to the air, making direct contact with the human body when inserted into the human body. The outer insulating thin film layer 1 is a stretchable material including polydimethylsiloxane, linear triblock copolymer or polylactic acid, with a thickness of 35 μm.

[0051] As Figure 4 shown, in the initial state without gas or liquid filled, the integrated structure composed of the adhesion layer 4, the substrate layer 3, the flexible electrode array thin film layer 2 and the outer insulating thin film layer 1 reserves out-of-plane extension space through a multi-layer folding form to adapt to a small volume. Such a special structure, combined with the 50-μm thickness and low Young's modulus of the flexible electrode array thin film layer 2, enables the out-of-plane origami not to warp, but to yield to the stress in a certain direction and topple layer by layer, finally forming a structure like fish scales to enhance the comfort when entering the human body. During application, the input port of the inflatable support layer 5 is connected to a pipe 6 with a round hole. After filling the gas or liquid through the pipe 6, the inflatable support layer 5 expands. Affected by the increase in the internal volume of the inflatable 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 adhesion layer 4, the substrate layer 3, the flexible electrode array thin film layer 2 and the outer insulating thin film layer 1 expands together. Finally, the thin film of the integrated structure is completely flattened, forming an olive-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, improving the accuracy of the signal. After the inflation or liquid filling is completed, closing the pipe 6 can maintain the complete sealing of the inner layer, achieving the support effect through air pressure or water pressure.

[0052] As 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, wherein the distribution mode of the integrated structure is to evenly distribute multiple pieces of structure on the outer surface of the expandable support layer along the circumferential direction of the pipeline, and each piece of structure is divided into multiple folds, and 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 structure are in a flat origami form with multiple layers of folded arrangement when not expanded.

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 during use.

4. The expandable air-bag anorectal function assessment probe according to claim 1, 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.

5. 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.

6. 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.

7. 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.

8. 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-300 μm.

9. 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 ductile adhesive with a gradually increasing Young's modulus, and the ductile adhesive comprises polyvinyl alcohol, polyhydroxyethyl acrylate and / or polyacrylamide.

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