Multi-mode anorectal detection probe

Abstract

The invention relates to the technical field of medical auxiliary equipment, in particular to a multi-mode anorectal detection probe which comprises a shell, a temperature control sensor, an electrode and an air bag, the temperature control sensor is arranged at the end of the shell, the electrode is arranged on the outer surface of the shell, and the air bag is arranged in the shell. The air bag is arranged at the other end, away from the temperature control sensor, of the shell, the end where the air bag is arranged is the end making contact with the human body, the electrode comprises three electrode bands spirally extending along the longitudinal axis of the outer surface of the shell, and the three electrode bands are evenly distributed in the circumferential direction of the shell. The air bag is arranged in the shell and is axially divided into a far-end area used for identifying outer anal sphincter, a middle area used for identifying inner anal sphincter and a near-end area used for identifying puborectum muscle along the shell, and the air bag comprises an air bag front chamber, an air bag middle chamber and an air bag rear chamber which are mutually independent. Therefore, the scientificity, the accuracy and the clinical curative effect of BFES treatment are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical auxiliary equipment, and in particular to a multimodal anorectal detection probe. Background Art

[0002] Functional constipation (FC) is a common gastrointestinal disorder worldwide, significantly impacting the physical and mental health and quality of life of children, adults, and the elderly. According to the latest research, the prevalence rate is as high as 14% in adults and 9.5% in children. Constipation not only causes local symptoms such as abdominal distension, pain, and dyspnea, but is also closely associated with cardiovascular and cerebrovascular events, with an all-cause mortality rate 12% higher than that of the general population. Because FC's early symptoms are subtle, patients often neglect to seek medical attention, leading to prolonged illness. Some patients ultimately require long-term medication or even bowel resection, placing a heavy burden on their health and socioeconomic well-being. In recent years, with the deepening of research into intestinal motility mechanisms, biofeedback therapy (BFT) has emerged as an important non-pharmacological treatment for chronic constipation, particularly outlet obstructive constipation. In particular, biofeedback combined with electrical stimulation (BFES) has shown promising results in improving pelvic floor muscle coordination and enhancing intestinal motility.

[0003] However, existing BFES devices still have many limitations in design and function, which seriously restrict their widespread application and improvement of efficacy in clinical practice. First, most current treatment plans use biofeedback and electrical stimulation in steps or alternately, lacking a synchronous fusion control mechanism, making it difficult to achieve precise adjustment and personalized treatment; second, traditional anal plug electrodes mainly stimulate the external anal sphincter and fail to effectively cover the internal anal sphincter and rectal area, resulting in inaccurate positioning of the stimulation site and uncontrollable stimulation intensity, affecting the treatment effect; in addition, existing devices generally lack real-time monitoring and feedback functions of pressure changes in the anorectal area, and cannot dynamically evaluate physiological responses during treatment. Summary of the Invention

[0004] The purpose of the present invention is to provide a multimodal anorectal detection probe to achieve synchronous monitoring and precise regulation of multiple parameters in the anorectal area, thereby improving the scientificity, precision and clinical efficacy of BFES treatment.

[0005] To achieve the above object, the present invention provides the following technical solutions: The present invention provides a multimodal anorectal detection probe, comprising a housing, a temperature control sensor, electrodes and an air bag; The temperature control sensor is arranged at an end of the shell, the electrode is arranged on the outer surface of the shell, and the airbag is arranged at the other end of the shell away from the temperature control sensor, and the end where the airbag is arranged is the end in contact with the human body; The electrodes include three electrode belts extending spirally along the longitudinal axis of the outer surface of the shell, wherein each electrode belt is integrated with alternatingly spaced electrical stimulation electrodes and EMG electrodes, as well as a gel pocket for accommodating conductive gel, and the three electrode belts are evenly distributed along the circumference of the shell and divided along the axial direction of the shell into a distal region for identifying the external anal sphincter, a middle region for identifying the internal anal sphincter, and a proximal region for identifying the puborectalis muscle; The airbag comprises a front airbag chamber, a middle airbag chamber and a rear airbag chamber which are independent of each other.

[0006] In some embodiments, the gel pocket is a blind hole structure provided on the surface of the electrical stimulation electrode and the EMG electrode, and a conductive gel is provided inside the blind hole structure.

[0007] In some embodiments, the shell includes an outer shell and an inner shell that are nested with each other, the electrode belt is arranged on the surface of the outer shell, and the airbag is arranged on the head of the outer shell.

[0008] In some embodiments, a cable conduit for accommodating electrode wires is further included, wherein the cable conduit is formed by splicing corresponding grooves formed on the outer wall of the inner shell and the inner wall of the outer shell.

[0009] In some embodiments, the groove is semicircular.

[0010] In some embodiments, an inner pipe is formed in the middle of the inner shell, and the airbag front chamber, the airbag middle chamber and the airbag rear chamber are respectively connected to the inner pipe through independent connecting pipes.

[0011] In some embodiments, the airbag is made of medical TPU high-stretch film.

[0012] In some embodiments, the volume ratio of the airbag front chamber, the airbag middle chamber, and the airbag rear chamber is 1:1:1.

[0013] Furthermore, the beneficial effects of the present invention are: The present invention increases the contact area between the probe and the patient's anorectum by arranging multiple electrodes and air bags on the probe. At the same time, it realizes the synchronous acquisition of physiological signals of the three major muscle groups: the external anal sphincter, the internal anal sphincter and the puborectalis muscle, providing a reliable data basis for accurate diagnosis. At the same time, the independent partitioning and independent controllability of the air bag structure realizes the partitioning, grading, and time-sequential pressure stimulation and detection of the rectal ampulla, the middle part of the anal canal and the upper part of the anal canal / puborectalis muscle area, which can dynamically simulate the filling and discharge process of feces, and more comprehensively and physiologically evaluate the sensory and motor function of the anorectal canal, thereby improving the scientificity, accuracy and clinical efficacy of BFES treatment.

[0014] In addition, on this basis, the inner shell and the outer shell in the present invention are snap-connected, so when the airbag in the present invention fails, it is convenient for the user to disassemble and repair it, which is convenient to use and has broad application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 This is a schematic diagram of the structure of the multi-modal anorectal detection probe provided by the present invention after the airbag is inflated; Figure 2 This is a schematic diagram of the structure of the airbag in the multimodal anorectal detection probe provided by the present invention after it is not inflated; Figure 3 This is a schematic diagram of the internal structure of the shell of the multimodal anorectal detection probe provided by the present invention.

[0016] In the figure: 1-front chamber of airbag, 2-middle chamber of airbag, 3-outer shell, 4-gel bag groove, 5-EMG electrode, 6-electric stimulation electrode, 7-temperature control sensor, 8-cable pipe, 9-inner shell, 10-inner pipe, 11-rear chamber of airbag. DETAILED DESCRIPTION

[0017] The following, in conjunction with the accompanying drawings, provides a clear and complete description of the technical solutions in the embodiments of the present invention. It should be understood that the described embodiments are only a portion of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments derived by persons of ordinary skill in the art without inventive effort are within the scope of protection of the present invention. In the description of the embodiments of the present invention, unless otherwise specified, " / " represents an "or" (or). For example, "A / B" can represent either A or B. "And / or" in the text is merely a description of an association between related objects, indicating that three relationships can exist. For example, "A and / or B" can represent: A exists alone, A and B exist simultaneously, or B exists alone. Furthermore, in the description of the embodiments of the present invention, "plurality" refers to two or more. The terms "first" and "second" are used for descriptive purposes only and should not be construed to imply or suggest relative importance or to implicitly specify the number of the technical features indicated. Therefore, features designated "first" and "second" may explicitly or implicitly include one or more of such features. In the description of the embodiments of the present invention, unless otherwise specified, "plurality" means two or more.

[0018] like Figure 1-Figure 3 As shown, the present invention provides a multimodal anorectal detection probe, comprising: a housing, a temperature control sensor 7, electrodes and an air bag; The temperature control sensor 7 is arranged at the end of the shell, the electrode is arranged on the outer surface of the shell, and the airbag is arranged at the other end of the shell away from the temperature control sensor 7, and the end where the airbag is arranged is the end in contact with the human body; The electrodes include three electrode strips extending spirally along the longitudinal axis of the outer surface of the shell, wherein each electrode strip is integrated with alternatingly spaced electrical stimulation electrodes 6 and EMG electrodes 5, as well as a gel pocket 4 for accommodating conductive gel. The three electrode strips are evenly distributed along the circumference of the shell and are divided along the axial direction of the shell into a distal region for identifying the external anal sphincter, a middle region for identifying the internal anal sphincter, and a proximal region for identifying the puborectalis muscle. The airbag includes a front airbag chamber 1 , a middle airbag chamber 2 and a rear airbag chamber 11 which are independent of each other.

[0019] In the above structure, three electrode belts are wound around the outer surface of the shell at a certain spiral angle and are evenly spaced along the circumference of the shell, wherein the spacing angle can be 120°. The present invention does not make specific limitations. At the same time, through the three spirally distributed integrated electrode belts and their clear axial partitioning, synchronous electrical stimulation and electromyographic signal acquisition of the target muscle groups of the external anal sphincter, internal anal sphincter and puborectalis muscle are achieved. At the same time, by setting three independent front, middle and rear airbag chambers, the partitioning of different functional areas of the rectum and anal canal, independent and controllable pressure stimulation and sensory function evaluation are achieved.

[0020] The present application increases the contact area of the probe with the patient's anorectal by providing multiple electrodes and an airbag on the probe, and simultaneously realizes the synchronous collection of physiological signals of the three muscle groups of the external anal sphincter, the internal anal sphincter and the puborectalis muscle, providing a reliable data basis for accurate diagnosis, and the independent partitioning and independent controllability of the airbag structure realizes the partitioning, grading, time sequence pressure stimulation and detection of the rectal ampulla, middle segment of the anal canal and upper segment of the anal canal / puborectalis muscle area, dynamically simulates the feces filling and discharge process, and more comprehensively and physiologically evaluates the sensory and motor function of the anal canal and rectum, thereby improving the scientificity, accuracy and clinical efficacy of BFES treatment. The present application has simple structure, convenient use and wide application prospect.

[0021] In one possible implementation, the gel capsule groove 4 is a blind hole structure arranged on the surface of the electrical stimulation electrode 6 and the EMG electrode 5, and a conductive gel is arranged inside the blind hole structure. On the surface of each electrode, a blind hole structure is processed as the gel capsule groove 4, and a slow-release conductive gel is pre-filled by dispensing process before use, thereby enhancing the tissue contact interface and reducing the resistance.

[0022] In one possible implementation, the shell includes an outer shell 3 and an inner shell 9 nested with each other, the electrode belt is arranged on the surface of the outer shell 3, the airbag is arranged at the head of the outer shell 3, and a cable conduit 8 for accommodating electrode wires is further arranged. The cable conduit 8 is spliced by corresponding grooves formed on the outer wall of the inner shell 9 and the inner wall of the outer shell 3, and the grooves are semicircular. In the above embodiment, the outer shell 3 and the inner shell 9 are designed to be nested with each other to separate the electrode belt, the airbag and the internal cable conduit 8, thereby simplifying the production process and facilitating subsequent maintenance. Meanwhile, the two semicircular grooves are spliced to form the cable conduit 8, thereby realizing the effect of orderly and stably constraining the wires in the preset path and avoiding the failure caused by cable winding, wear and tear and pulling during repeated bending of the probe.

[0023] In one possible implementation, an inner conduit 10 is formed in the middle of the inner shell 9, and the airbag front chamber 1, the airbag middle chamber 2 and the airbag rear chamber 11 are respectively connected to the inner conduit 10 through independent connecting pipes, thereby realizing the independence of the control of each chamber in the airbag front chamber 1, the airbag middle chamber 2 and the airbag rear chamber 11.

[0024] In one possible implementation, the airbag is made of medical TPU high ductility film. By using the medical TPU high ductility film to make the airbag, on the one hand, the airbag has excellent flexibility and resilience, and on the other hand, the airbag itself has good tear resistance, thereby ensuring the durability of the airbag during repeated pressure charging and discharging.

[0025] In one possible implementation, the volume ratio of the front airbag chamber 1, the middle airbag chamber 2 and the rear airbag chamber 11 is 1:1:1. The present invention uses the front airbag chamber 1, the middle airbag chamber 2 and the rear airbag chamber 11 of the same volume, thereby reducing the error value when evaluating different areas of the rectum, making the detection results more objective and reliable.

[0026] In the above embodiment, the physiological signals collected by the probe are transmitted to the back-end signal processing and host system via a cable, wherein the system workflow is as follows: The electrical stimulation electrode 6, the EMG electrode 5 and the built-in conductive gel capsule slot 4 first collect the original electromyographic signals, and simultaneously collect the pressure signals of the three airbag chambers, and the temperature control sensor 7 collects the temperature signal. At this time, the system's built-in signal processing algorithm calculates the electromyographic activity levels of the external anal sphincter, the internal anal sphincter and the puborectalis muscle according to the electrode signal sources in the distal, middle and proximal areas. Based on this, the system's own algorithm will apply electrical stimulation of preset parameter frequency intensity through the electrical stimulation electrode 6 based on the calculated data, according to the preset treatment plan or the weak links of the electromyographic signals detected in real time, so as to achieve the best rehabilitation effect.

[0027] The system also comprehensively assesses the sensory, motor, and coordination functions of the anorectal canal by analyzing parameters such as pressure thresholds, contraction response speed, and muscle coordination of each muscle group under different balloon inflation conditions. Ultimately, it generates a comprehensive clinical report containing graphs, data tables, and diagnostic recommendations.

[0028] Obviously, those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if such changes and modifications fall within the scope of the claims and their equivalents, the present invention is intended to include such changes and modifications.

Claims

1. A multimodal anorectal detection probe, characterized in that: include: Housing, temperature control sensor, electrodes and airbag; The temperature control sensor is arranged at an end of the shell, the electrode is arranged on the outer surface of the shell, and the airbag is arranged at the other end of the shell away from the temperature control sensor, and the end where the airbag is arranged is the end in contact with the human body; The electrodes include three electrode belts extending spirally along the longitudinal axis of the outer surface of the shell, wherein each electrode belt is integrated with alternatingly spaced electrical stimulation electrodes and EMG electrodes, as well as a gel pocket for accommodating conductive gel, and the three electrode belts are evenly distributed along the circumference of the shell and divided along the axial direction of the shell into a distal region for identifying the external anal sphincter, a middle region for identifying the internal anal sphincter, and a proximal region for identifying the puborectalis muscle; The airbag comprises a front airbag chamber, a middle airbag chamber and a rear airbag chamber which are independent of each other.

2. The multimodal anorectal detection probe according to claim 1, characterized in that: The gel capsule groove is a blind hole structure arranged on the surface of the electrical stimulation electrode and the EMG electrode, and conductive gel is arranged inside the blind hole structure.

3. The multimodal anorectal detection probe according to claim 1, characterized in that: The shell comprises an outer shell and an inner shell which are nested with each other, the electrode belt is arranged on the surface of the outer shell, and the airbag is arranged on the head of the outer shell.

4. The multimodal anorectal detection probe according to claim 3, characterized in that: It also includes a cable conduit for accommodating electrode wires, wherein the cable conduit is formed by splicing corresponding grooves formed on the outer wall of the inner shell and the inner wall of the outer shell.

5. The multimodal anorectal detection probe according to claim 4, characterized in that: The groove is semicircular.

6. The multimodal anorectal detection probe according to claim 5, characterized in that: An inner pipe is formed in the middle of the inner shell, and the airbag front chamber, the airbag middle chamber and the airbag rear chamber are respectively connected to the inner pipe through independent connecting pipes.

7. The multimodal anorectal detection probe according to claim 1, characterized in that: The airbag is made of medical TPU high-stretch film.

8. The multimodal anorectal detection probe according to claim 1, wherein: The volume ratio of the airbag front chamber, the airbag middle chamber and the airbag rear chamber is 1:1:1.

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