Lying-position defecation assisting system

The supine assistive system, which combines abdominal pressure sensors and electromyographic electrodes, utilizes a dual-threshold strategy and a neurostimulation unit to accurately identify defecation intentions and apply electrical stimulation, solving defecation problems in the elderly and patients with spinal cord injuries, and achieving efficient and precise defecation assistance.

CN121102718AActive Publication Date: 2025-12-12GUANGANMEN HOSPITAL CHINA ACAD OF CHINESE MEDICAL SCI
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Patent Information

Application Number
CN202511393208.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-09-27
Publication Date
2025-12-12
Estimated Expiration
2045-09-27

AI Technical Summary

Technical Problem

In existing technologies, it is difficult to effectively solve defecation dysfunction in the elderly, patients with spinal cord injuries, and people who are bedridden after abdominal surgery. Traditional methods have limitations and side effects, cannot accurately identify defecation intentions, and have poor stimulation effects.

Method used

The supine assistive system, which combines an abdominal pressure sensor and electromyographic electrodes, identifies defecation intentions through a dual-threshold strategy. It uses a neuro-electrical stimulation unit to electrically stimulate sacral nerve targets, and combines this with a camera unit to collect defecation information. The system dynamically adjusts the adhesion pressure and weighting coefficient of the electrode patches to achieve precise defecation assistance.

Benefits of technology

It accurately identifies the intention to defecate, reduces the misjudgment rate, improves the efficiency of defecation assistance, reduces the rate of stimulation effect decay, adapts to different body position changes, reduces patient discomfort, and improves compliance.

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Abstract

The invention discloses a clinostatism auxiliary defecation system, which comprises an abdominal pressure sensor, a flexible patch, a main control unit and a nerve electrical stimulation unit, wherein the flexible patch is arranged on the perianal skin and is provided with a myoelectricity electrode; the abdominal pressure sensor is used for collecting abdominal pressure, the myoelectric electrode is used for collecting myoelectric signals of anus external sphincter, and the main control unit is connected with the abdominal pressure sensor, the myoelectric electrode and the nerve electrical stimulation unit; when the abdominal cavity pressure collected by the abdominal pressure sensor in real time is 2.5 times larger than the resting abdominal pressure, the amplitude of electromyographic signals collected by the electromyographic electrodes is reduced to 30% or below of the resting state, the duration time is longer than or equal to 2 seconds, and the time is the defecation opportunity, the main control unit controls the nerve electric stabbing unit to start electrical stimulation of sacral nerve targets. According to the method, the defecation intention is accurately recognized, the misjudgment rate is reduced, the defecation assisting efficiency is improved, the stimulation effect attenuation rate is reduced, the measurement precision is kept for different body positions of a patient, and rapid application and displacement prevention of the nursing pad are achieved.
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Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical rehabilitation engineering and intelligent sensing control technology, in particular to a lying position defecation auxiliary system. BACKGROUND

[0002] Defecation dysfunction is a high-incidence complication of the elderly, spinal cord injury patients and postoperative bedridden people. About 150 million long-term bedridden people in the world are troubled by this problem, among which the incidence of constipation in patients over 60 years old in China reaches 67%, and the defecation dysfunction rate of postoperative patients in ICU is as high as 83%. This disease not only reduces the quality of life of patients, such as causing abdominal distension, abdominal pain, sleep disorders, but also can lead to serious complications.

[0003] Complications of defecation function include: intestinal complications, the risk rate of fecal impaction causing intestinal obstruction reaches 12%, and the risk of colorectal polyp cancer in long-term constipation increases by 2.3 times; cardiovascular load: abdominal pressure rises sharply during defecation, which can cause blood pressure fluctuations of more than 40 mmHg, inducing acute myocardial infarction or stroke in elderly patients, and acute myocardial infarction or stroke accounts for 8.7% of the causes of sudden death in bedridden patients.

[0004] Traditional solutions have significant technical bottlenecks, such as the limitations of conservative treatment methods, drug intervention, and giving patients volume laxatives such as lactulose, but lactulose takes effect slowly, about 48-72 hours, and is ineffective for 80% of severe constipation patients. Patients are given stimulant laxatives such as senna and bisacodyl, but long-term use can cause damage to the intestinal myenteric plexus, and the recovery rate of intestinal motility in users for more than 5 years is less than 20%.

[0005] Existing physical assistance methods require medical staff to wear gloves to operate, and patients have poor compliance due to shame, and the rectal mucosa is torn. In addition, enema treatment can easily destroy the balance of intestinal flora, and the number of intestinal probiotics of long-term users decreases by 40%, and cannot solve neurogenic defecation disorders.

[0006] Therefore, the existing technology has problems that need to be further improved and developed. SUMMARY

[0007] (I) Invention purpose: In order to solve the problems existing in the prior art, the purpose of the present application is to provide a lying position defecation auxiliary system.

[0008] (II) Technical solution: In order to solve the above technical problems, the present technical solution provides a lying position defecation auxiliary system, which comprises an abdominal pressure sensor, a flexible patch with a myoelectricity electrode arranged on the perianal skin, a main control unit and a nerve electric stimulation unit. The abdominal pressure sensor is used to collect the abdominal pressure, the myoelectricity electrode collects the myoelectricity signal of the external anal sphincter, and the main control unit is connected with the abdominal pressure sensor, the myoelectricity electrode and the nerve electric stimulation unit respectively; When the abdominal pressure collected by the abdominal pressure sensor in real time is greater than 2.5 times of the resting abdominal pressure, and the amplitude of the myoelectricity signal collected by the myoelectricity electrode is reduced to less than 30% of the resting state, and the duration is greater than or equal to 2 seconds, it is the defecation opportunity, and the main control unit controls the nerve electric stimulation unit to start the electric stimulation of the sacral nerve target point.

[0009] The lying position auxiliary defecation system, wherein the nerve electric stimulation unit comprises an electrode patch, the electrode patch is a butterfly-shaped flexible structure, the electrode patch is arranged at the sacral nerve target point, covers the S3-S4 ganglion projection area of the sacrococcygeal part, and the electrode edge is provided with a hydrogel buffer ring, and the adhesion pressure is less than or equal to 2 kPa.

[0010] The lying position auxiliary defecation system, wherein the lying position auxiliary defecation system further comprises a camera unit, the main control unit is connected with the camera unit, and the camera unit collects defecation information; the nerve electric stimulation unit further comprises electrode patches arranged at the femoral nerve target point, the perineal nerve target point and the tibial nerve target point respectively. When the anal sphincter tension of the myoelectricity signal is greater than the myoelectricity amplitude in the resting state, the nerve electric stimulation unit places the electrode patch at the sacral nerve target point; when the abdominal pressure and the myoelectricity signal meet the defecation opportunity, but there is no defecation information, the nerve electric stimulation unit starts the electrode patch at the sacral nerve target point to perform electric stimulation; When the abdominal pressure is greater than 1.5 times of the resting value for more than 3 times within 30 seconds, but the myoelectricity signal is not in the defecation opportunity, the nerve electric stimulation unit starts the electrode patch arranged at the tibial nerve target point to perform stimulation.

[0011] The lying position auxiliary defecation system, wherein the abdominal pressure sensor is a flexible array type sensing unit, comprising three pressure sensing points arranged in an isosceles triangle, two waist side points and one umbilical point, each sensing point has a diameter of 6 mm; the sensor base has a thickness of less than or equal to 0.3 mm and is made of medical silica gel material, and is adhered to the skin by low-sensitivity acrylic adhesive.

[0012] The lying position auxiliary defecation system, wherein each pressure sensing point of the abdominal pressure sensor arranged in an isosceles triangle is provided with a micro gyroscope, and the main control unit is connected with the micro gyroscope, which is used to monitor the spatial posture change of the sensing point in real time, and the weight coefficients of the three pressure sensing points are dynamically allocated according to the inclination angle.

[0013] The lying position auxiliary defecation system, wherein when the inclination angle of any pressure sensing point is in the range of 15°-30°, the weight coefficients of the three pressure sensing points are allocated as follows: The left waist side sensing point is inclined, the weight coefficient of the right waist side sensing point is 0.3, and the weight coefficient of the umbilical sensing point is 0.2; the real-time measured abdominal pressure value = the pressure value of the left waist side sensing point * 0.5 + the pressure value of the right waist side sensing point * 0.3 + the pressure value of the umbilical sensing point * 0.2. The right waist side sensing point is inclined, the weight coefficient of the left waist side sensing point is 0.3, and the weight coefficient of the umbilical sensing point is 0.2; the real-time measured abdominal pressure value = the pressure value of the left waist side sensing point * 0.3 + the pressure value of the right waist side sensing point * 0.5 + the pressure value of the umbilical sensing point * 0.2. The umbilical sensing point is inclined, the weight coefficient of the left waist side sensing point and the right waist side sensing point is 0.4, and the real-time measured abdominal pressure value = the pressure value of the left waist side sensing point * 0.4 + the pressure value of the right waist side sensing point * 0.4 + the pressure value of the umbilical sensing point * 0.2.

[0014] The lying position auxiliary defecation system, wherein when the inclination angle of any pressure sensing point is greater than 30°, the weight coefficients of the three pressure sensing points are distributed as follows: When the left waist side sensing point is inclined, the corresponding weight coefficient of the right waist side sensing point is 0.5, and the weight coefficient of the umbilical sensing point is 0.3; the real-time measured abdominal pressure value = the pressure value of the right waist side sensing point * 0.5 + the pressure value of the left waist side sensing point * 0.2 + the pressure value of the umbilical sensing point * 0.3. When the right waist side sensing point is inclined, the corresponding weight coefficient of the left waist side sensing point is 0.5, and the weight coefficient of the umbilical sensing point is 0.3; the real-time measured abdominal pressure value = the pressure value of the left waist side sensing point * 0.5 + the pressure value of the right waist side sensing point * 0.2 + the pressure value of the umbilical sensing point * 0.3. The umbilical sensing point is inclined, the weight coefficient of the left waist side sensing point is 0.45, and the weight coefficient of the right waist side sensing point is 0.45; the real-time measured abdominal pressure value = the pressure value of the left waist side sensing point * 0.45 + the pressure value of the right waist side sensing point * 0.45 + the pressure value of the umbilical sensing point * 0.1.

[0015] The lying position auxiliary defecation system, wherein the flexible array type sensing unit further comprises a ring-shaped elastic frame surrounding the three pressure sensing points, the frame is made of silica gel material, the width is 5mm, the height is 1.2mm, and a micro suction cup is integrated on the inner side of the frame.

[0016] The lying position auxiliary defecation system, wherein the abdominal pressure sensor and the flexible patch of the electromyography electrode are integrated with the disposable medical nursing pad through degradable hot melt adhesive.

[0017] The lying position auxiliary defecation system, wherein the surface of the nursing pad is provided with a hollow positioning area matched with the pressure sensing points of the flexible array type sensing unit, and a diamond grid embossment is arranged in the waist and abdomen adhering area.

[0018] (III) Beneficial effects: The defecation auxiliary system in a lying position provided by the application can accurately identify defecation intention, effectively distinguish non-defecation actions such as coughing and turning over, and reduce the misjudgment rate; multi-target point nerve electrical stimulation can improve the defecation auxiliary efficiency; the stimulation effect decay rate is reduced; different weight coefficients are allocated to different inclination angles, so that the measurement accuracy is maintained when the patient changes the body position such as turning over and lying on one side; and the nursing pad can be quickly attached and prevented from shifting. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 is a functional structure schematic diagram of the defecation auxiliary system in a lying position of the application; Figure 2 is a butterfly-shaped electrode patch structure schematic diagram of the defecation auxiliary system in a lying position of the application; Figure 3 is a schematic diagram of the arrangement of the micro-channel outlet of the butterfly-shaped electrode patch of the defecation auxiliary system in a lying position of the application. DETAILED DESCRIPTION

[0020] The application will be further described below in conjunction with preferred embodiments, and more details are set forth in the following description in order to fully understand the application, but the application can certainly be implemented in various ways different from the description, and those skilled in the art can make similar generalizations and deductions according to actual application conditions without departing from the connotation of the application, so the protection scope of the application should not be limited by the specific embodiments.

[0021] The accompanying drawings are schematic diagrams of the embodiments of the application, and it should be noted that the drawings are only examples and are not drawn according to the condition of the same scale, and should not be used as a limitation on the actual claimed protection scope of the application.

[0022] The application provides a defecation auxiliary system in a lying position, as shown in Figure 1 which includes an abdominal pressure sensor, a flexible patch with a myoelectric electrode arranged on the perianal skin, a main control unit and a nerve electrical stimulation unit. The abdominal pressure sensor is used to collect the abdominal cavity pressure, the myoelectric electrode collects the myoelectric signal of the external anal sphincter, and the main control unit is connected with the abdominal pressure sensor, the myoelectric electrode and the nerve electrical stimulation unit respectively. When the abdominal cavity pressure collected by the abdominal pressure sensor in real time is greater than 2.5 times the resting abdominal pressure, and the amplitude of the myoelectric signal collected by the myoelectric electrode decreases to less than 30% of the resting state, and the duration is greater than or equal to 2 seconds, this is the defecation opportunity, and the main control unit controls the nerve electrical stimulation unit to start the sacral nerve target electrode patch, that is, to start the electrical stimulation of the sacral nerve target.

[0023] The auxiliary defecation system for the lying position adopts a double threshold value judgment strategy of abdominal cavity pressure and electromyographic signal of the external anal sphincter to determine whether there is a defecation intention, and then adopts transcutaneous nerve electric stimulation defecation after determining the defecation intention, thereby avoiding invasive operation and being suitable for long-term lying patients, such as patients with spinal cord injury and postoperative LARS patients (patients with low anterior resection syndrome).

[0024] The abdominal pressure sensor adopts a micro air pressure sensor, is implanted in a waist abdominal binding belt with a precision of ±0.5 mmHg, and monitors the pressure change in the abdominal cavity in real time. The resting abdominal pressure base value is 10-15 mmHg, when the abdominal cavity pressure is greater than 2.5 times of the resting abdominal pressure, that is, 25-37.5 mmHg, it is the defecation abdominal pressure threshold value, and the misjudgment of non-defecation actions such as coughing and turning over is avoided.

[0025] In the auxiliary defecation system for the lying position, the flexible patch with the electromyographic electrode arranged on the perianal skin can be attached to the surface projection area of the external anal sphincter, that is, usually centered on the anus, that is, the annular range of 2-3 cm around the anus and the region from the coccyx to the perineum, so as to ensure the stimulation or monitoring effect. The electromyographic electrode is used to collect the electromyographic (EMG) signal of the external anal sphincter, that is, the electromyographic signal of the external anal sphincter. When the amplitude of the collected electromyographic signal is reduced to less than 30% of the resting state, it indicates that the sphincter is relaxed, and the duration is greater than or equal to 2 seconds, which is determined as a defecation precursor.

[0026] When the abdominal cavity pressure is greater than 2.5 times of the resting abdominal pressure, and the amplitude of the electromyographic signal is reduced to less than 30% of the resting state, and the duration is greater than or equal to 2 seconds, the system determines that there is a defecation intention, and starts the electric stimulation auxiliary defecation to convert passive waiting defecation into active triggering assistance.

[0027] In a preferred embodiment of the auxiliary defecation system for the lying position, the nerve electric stimulation unit comprises an electrode patch, the electrode patch is a butterfly-shaped flexible structure, the electrode patch is arranged at the sacral nerve target point, covers the S3-S4 ganglion projection area of the sacrococcygeal part, and the electrode edge is provided with a hydrogel buffer ring with a fitting pressure of less than or equal to 2 kPa, and the preferred embodiment is as follows: The electrode patch adopts a bionic butterfly-shaped symmetrical structure, such as Figure 2As shown, the overall size is 60mm x 45mm, consisting of a central stimulation area and bilateral wings. The central stimulation area is circular with a diameter of 15mm, corresponding to the core target of the sacrococcygeal S3-S4 ganglion projection area, and four gold-plated electrode contacts with a diameter of 3mm are built in, which are arranged in a square or circular pattern with a spacing of 5mm for precise release of electrical stimulation signals. The bilateral wings are symmetrical arc-shaped wing structures, with a unilateral wing span of 25mm and a thickness of 0.3mm. They are made of shape memory polyimide base and are integrally formed by 4D printing technology, and can adaptively bend with the physiological curvature of the sacrococcygeal region, with a deformation angle of ±30°, ensuring that the fitting area with the skin surface is ≥90%. The edges of the wing part of the electrode patch are treated with a 0.5mm radius fillet to avoid skin compression, and two 5mm diameter fixing holes are provided at the end of the wing part to cooperate with the medical tape for auxiliary fixation to prevent displacement.

[0028] The electrode patch of the present application is a four-layer composite structure, from top to bottom: The first layer is a protective layer: a 10μm thick polyethylene terephthalate (PET) film with a release paper on the surface, which is peeled off during use.

[0029] The second layer is a conductive layer: a nano-Ag paste printed circuit with a line width of 0.2mm and an impedance of ≤50Ω, which realizes stable conductivity during stretching through a serpentine wiring design with a maximum stretching rate of 20%.

[0030] The third layer is a flexible base: 50μm thick shape memory polyimide (SMPI) with a Tg temperature of 180℃ and a breaking elongation of 300%, ensuring no risk of cracking during body surface activity.

[0031] The fourth layer is a hydrogel layer: a 200μm thick conductive hydrogel covers the central stimulation area, with a conductivity of ≥1S / cm and a pH value of 6.5-7.5.

[0032] The electrode patch of the present application can also preferably be provided with a buffer ring at the edge of the electrode, which is provided 1mm away from the outer edge of the patch. The buffer ring is a ring-shaped hydrogel buffer ring with a semicircular cross-section, a width of 3mm and a height of 1.5mm, made of high-elasticity transparent hydrogel, which realizes dynamic adjustment of the fitting pressure through a biomimetic microarray structure, ensuring an average fitting pressure of ≤2kPa.

[0033] In the preferred embodiment of the present application, the nerve electrical stimulation unit comprises an electrode patch for 3 groups of core stimulation targets arranged at sacral nerve targets, femoral nerve targets and perineal nerve targets, covering the defecation-related neural pathways, and an electrode patch for 1 group of auxiliary adjustment stimulation targets arranged at tibial nerve targets. The sacral nerve targets are S3-S4 nerve roots, and when the electrode patch is placed at the sacral nerve targets, the central stimulation area of the electrode patch corresponds to the S3-S4 nerve roots. The sacral nerve targets directly activate the defecation reflex arc, promote rectal peristalsis and relaxation of the external anal sphincter; the femoral nerve targets are the femoral nerve running area, and when the targets are stimulated, the lower limb muscle groups can be adjusted to synergistically contract, indirectly increasing abdominal pressure to assist defecation; the perineal nerve targets are superficial nerves in the perineal region, and when the targets are stimulated, the coordination of the anal sphincter and the pelvic floor muscles can be enhanced to avoid muscle over-tension or relaxation during defecation, and to assist in enhancing the coordination function of the sphincter; the tibial nerve targets are located above the medial malleolus, and when the targets are stimulated, the abnormal bladder-rectum reflex can be inhibited, and the frequent fluctuations in abdominal pressure can be reduced.

[0034] The defecation system also comprises a camera unit connected to the main control unit, which collects defecation information. The defecation information can be defecation images or signals input through the input unit indicating whether defecation has occurred. The camera unit can be a camera.

[0035] When the muscle tension of the external anal sphincter is greater than the muscle electrical amplitude in the resting state, the nerve electrical stimulation unit places the electrode patch at the sacral nerve targets; when the abdominal pressure and muscle electrical signals meet the defecation timing, but there is no defecation information, the nerve electrical stimulation unit starts the electrode patch at the sacral nerve targets for electrical stimulation. Specifically, when the defecation timing is met, the electrode patch at the sacral nerve targets is preferentially started for stimulation, and the electrode patch at the perineal nerve targets is jointly started for electrical stimulation according to the muscle tension state of the sphincter feedback by the muscle electrical signal, enhancing the coordination function of the sphincter; if the abdominal pressure amplitude is insufficient, the electrode patch at the femoral nerve targets can be additionally started for electrical stimulation to indirectly increase the abdominal pressure through the contraction of the lower limb muscle groups.

[0036] When the abdominal pressure exceeds 1.5 times the resting value for ≥3 times within 30 seconds, but the muscle electrical signal is not in the defecation timing, the nerve electrical stimulation unit starts the electrode patch arranged at the tibial nerve targets for stimulation to inhibit abnormal reflex and avoid interference of invalid electrical stimulation on the intestinal function.

[0037] The supine position auxiliary defecation system of the present application, the abdominal pressure sensor is a flexible array type sensing unit, including three pressure sensing points in an isosceles triangle distribution, including two waist side points and one umbilical point, each sensing point has a diameter of 6mm; the sensor base is made of medical silicone material with a thickness of ≤0.3mm, and is pasted on the skin by low-sensitivity acrylic adhesive. In the isosceles triangle distribution of the pressure sensing points of the abdominal pressure sensor, a micro gyroscope is built in each pressure sensing point, the main control unit is connected with the micro gyroscope, for real-time monitoring of the spatial attitude change of the sensing point, and the weight coefficients of the three pressure sensing points are dynamically allocated according to the inclination angle.

[0038] When the inclination angle of any pressure sensing point is in the range of 15°-30°, the weight coefficients of the three pressure sensing points are allocated as follows: When the waist left sensing point is inclined, the weight coefficient of the waist right sensing point is 0.3, the weight coefficient of the umbilical sensing point is 0.2, and the real-time measured abdominal pressure value = waist left sensing point pressure value × 0.5 + waist right sensing point pressure value × 0.3 + umbilical sensing point pressure value × 0.2; When the waist right sensing point is inclined, the symmetrically configured waist left sensing point weight coefficient is 0.3, the umbilical sensing point weight coefficient is 0.2, and the real-time measured abdominal pressure value = waist left sensing point pressure value × 0.3 + waist right sensing point pressure value × 0.5 + umbilical sensing point pressure value × 0.2; When the umbilical sensing point is inclined, the weight coefficients of the waist left sensing point and the waist right sensing point are both 0.4, and the real-time measured abdominal pressure value = waist left sensing point pressure value × 0.4 + waist right sensing point pressure value × 0.4 + umbilical sensing point pressure value × 0.2.

[0039] When the inclination angle of any pressure sensing point is > 30°, the weight coefficients of the three pressure sensing points are allocated as follows: When the waist left sensing point is inclined, the corresponding waist right sensing point weight coefficient is 0.5, the umbilical sensing point weight coefficient is 0.3, and the real-time measured abdominal pressure value = waist right sensing point pressure value × 0.5 + waist left sensing point pressure value × 0.2 + umbilical sensing point pressure value × 0.3; When the waist right sensing point is inclined, the corresponding waist left sensing point weight coefficient is 0.5, the umbilical sensing point weight coefficient is 0.3, and the real-time measured abdominal pressure value = waist left sensing point pressure value × 0.5 + waist right sensing point pressure value × 0.2 + umbilical sensing point pressure value × 0.3; When the umbilical sensing point is inclined, the waist left sensing point weight coefficient is 0.45, the waist right sensing point weight coefficient is 0.45; the real-time measured abdominal pressure value = waist left sensing point pressure value × 0.45 + waist right sensing point pressure value × 0.45 + umbilical sensing point pressure value × 0.1.

[0040] The flexible array type sensing unit also comprises a ring-shaped elastic frame surrounding the three pressure sensing points, the frame is made of silica gel material, the width is 5mm, the height is 1.2mm, and the inside of the frame is integrated with a micro suction cup.

[0041] The flexible patch of the abdominal pressure sensor and the myoelectricity electrode is integrated with a disposable medical nursing pad through degradable hot melt adhesive. The surface of the nursing pad is provided with a hollow positioning area matched with the pressure sensing points of the flexible array type sensing unit, and a diamond grid embossing is arranged in the waist and abdomen adhering area.

[0042] In the supine position defecation system, the flexible circuit layer of the electrode patch of the electric stimulation unit is integrated with a micro flow valve and a physiological saline micro channel, and the micro channel outlet of the physiological saline micro channel is located inside the hydrogel layer of the electrode patch. When the myoelectricity signal shows that the stimulation effect is attenuated, for example, the myoelectricity amplitude increase is less than 10% after continuous stimulation for three times, the electric stimulation unit controls the flow valve to release 0.1-0.3ml of physiological saline, which is permeated to the surface of the skin through the hydrogel layer, so as to reduce the electrode-skin impedance and maintain the humidity.

[0043] The preferred implementation of the array arrangement of the micro channel outlets of the physiological saline micro channel is as follows: the physiological saline micro channel is arranged in a regular triangle grid array inside the hydrogel layer, the single outlet of the micro channel outlet is a circular opening with a diameter of 0.5mm and a depth of 0.3mm, which is matched with the thickness of the hydrogel layer, and the edge of the micro channel outlet is transitioned by a 0.1mm round corner to avoid stress concentration and cause the hydrogel to crack.

[0044] The micro channel outlet array has a center distance of 3mm between adjacent outlets and is distributed in three concentric circles along the periphery of the central stimulation area of the electrode patch, as shown in the figure. Figure 3 The first circle is located in the inner circle, surrounds the outside of the four electrode contacts, and is provided with six outlets to form an inner ring with a diameter of 10mm; the second circle is located in the middle circle and is located at the edge of the central stimulation area, and is provided with twelve outlets to form a middle ring with a diameter of 15mm; the third circle is located in the outer circle and is distributed inside the bilateral wings, eight outlets are arranged in each side wing and are arranged in an arc shape, covering the edge area of the S3-S4 ganglion projection area. The total number of outlets of the micro channel outlet array is 6+12+16=34, which ensures that more than 90% of the area of the electrode patch in contact with the skin is covered when the physiological saline is released.

[0045] The micro channel outlet adopts an inverted funnel-shaped embedded structure, the top end of the outlet is in contact with the hydrogel, the diameter of the micro channel outlet is 0.5mm, the diameter of the bottom end of the micro channel outlet connected to the micro channel is 0.3mm, the outlet is formed on the polyimide substrate of the flexible circuit layer by laser etching process, and the inner wall of the outlet is plated with a 50nm thick titanium coating.

[0046] The microchannel array adopts a main channel, a branch channel, a Y-shaped polyimide microchannel built in a flexible circuit layer, the main channel extends from a liquid storage bag interface at the tail of a patch to a central stimulation area, and is branched into 34 microchannels each with a length of 5-15 mm and connected to microchannel outlets.

[0047] The micro one-way valve is arranged at the microchannel outlet, used for preventing physiological saline backflow or water gel reverse osmosis.

[0048] The four central contacts of the electrode patch collect sacrococcygeal electromyographic signals in real time, the sampling frequency is 1 kHz, the electromyographic amplitude increment in three continuous stimulation cycles, the stimulation parameters are as follows: frequency 50 Hz, pulse width 200 mu s, intensity 20-50 mA: when the increment is less than 10%, the stimulation effect is determined to be attenuated, and the physiological saline release of the micro one-way valve is immediately started.

[0049] The controller of the micro one-way valve can measure the skin-electrode impedance through the electrode contacts before release, if the initial impedance is greater than 5000 ohms, 0.3ml of physiological saline is directly released. When the increment is 8%-10%, 0.1ml is released, the impedance is re-measured after 30 seconds, if it is still greater than 3000 ohms, 0.1ml is additionally released; when the increment is 5%-8%, 0.2ml is released; when the increment is less than 5%, 0.3ml is released.

[0050] After the release of the physiological saline by the controller of the micro one-way valve, the impedance is continuously monitored, and the impedance is sampled every 5 minutes, when the impedance rises to more than 4000 ohms, the next 0.1ml of supplementary release is automatically triggered.

[0051] The flexible circuit layer of the present application integrates a micro flow valve and a physiological saline microchannel, through the arrayed layout of the microchannel outlet, precise flow control and impedance closed-loop feedback, the on-demand release of physiological saline is realized, the electrode-skin interface impedance is ensured to be stable less than 3000 ohms, and the long-term effectiveness of nerve electrical stimulation is improved.

[0052] The lying position auxiliary defecation system provided by the application can accurately identify defecation intention through the double-parameter judgment strategy of the 2.5 times threshold of resting abdominal pressure and the amplitude of electromyographic signal being reduced to less than 30% of the resting state and lasting for more than 2 seconds, effectively distinguishes non-defecation actions such as coughing and turning over, and reduces the misjudgment rate to less than 5%, solving the technical bottleneck of passive waiting or blind stimulation in traditional physical auxiliary means. Secondly, the application integrates three core target points of sacral nerve (S3-S4), tibial nerve and perineal nerve, and dynamically switches the stimulation mode according to different types of defecation disorders: preferentially stimulating the sacral nerve when the sphincter tension is abnormal, and starting tibial nerve regulation when the abdominal pressure frequently fluctuates but the sphincter does not relax. The success rate of defecation is increased by 40% compared with single target point stimulation, especially suitable for patients with neurogenic defecation disorders such as spinal cord injury and postoperative LARS, and the multi-target point neuroelectric stimulation improves the defecation auxiliary efficiency. Thirdly, the butterfly-shaped electrode patch of the application adopts a shape memory polyimide base with a deformation angle of ±30°, and a hydrogel buffer ring, so that the fitting pressure is ≤2kPa, and the stimulation effect is attenuated by 60%, and there is no risk of pressure ulcer for long-term wear. Fourthly, the flexible array type abdominal pressure sensor is used, and through the dynamic weight coefficient algorithm of the isosceles triangle distributed pressure sensing point and the micro gyroscope, the weight coefficient is distributed differently for different inclination angles, so that the measurement accuracy is maintained when the patient changes the body position such as turning over and lying on one side, which is an adaptive body position abdominal pressure monitoring technology. Finally, the sensor and the disposable nursing pad are integrated through degradable hot melt adhesive, the surface of the nursing pad is designed with a hollow positioning area and a rhombic grid embossing, which realizes rapid application and anti-displacement; and the physiological saline is released on demand through the micro flow valve to avoid cross infection risk.

[0053] The above is a description of preferred embodiments of the application, which can help those skilled in the art to more fully understand the technical solutions of the application. However, these embodiments are only illustrative and cannot be regarded as limitations on the specific embodiments of the application. For those skilled in the art to which the application belongs, without departing from the concept of the application, a number of simple deductions and changes can be made, which should be regarded as falling within the protection scope of the application.

Claims

1. A defecation assistance system for a supine position, characterized in that, It includes an abdominal pressure sensor, a flexible patch with electromyographic electrodes placed on the perianal skin, a main control unit, and a nerve electrical stimulation unit; The abdominal pressure sensor is used to collect abdominal pressure, the electromyographic electrode collects electromyographic signals of the external anal sphincter, and the main control unit is connected to the abdominal pressure sensor, the electromyographic electrode and the nerve electrical stimulation unit respectively. When the abdominal pressure collected in real time by the abdominal pressure sensor is greater than 2.5 times the resting abdominal pressure, and the amplitude of the electromyographic signal collected by the electromyographic electrode drops to less than 30% of the resting state for a duration of ≥2 seconds, it is time for defecation. The main control unit controls the nerve electrostimulation unit to start the electrical stimulation of the sacral nerve target.

2. The supine assisted defecation system according to claim 1, characterized in that, The neurostimulation unit includes an electrode patch, which is a butterfly-shaped flexible structure. The electrode patch is placed at the sacral nerve target point, covering the S3-S4 ganglion projection area of ​​the sacrococcygeal region, and a hydrogel buffer ring is provided at the edge of the electrode, with a bonding pressure ≤2kPa.

3. The supine defecation assistance system according to claim 1, characterized in that, It also includes a camera unit, the main control unit is connected to the camera unit, and the camera unit collects defecation information; the nerve electrical stimulation unit also includes electrode patches respectively disposed at the femoral nerve target point, the perineal nerve target point, and the tibial nerve target point; When the sphincter tone of the electromyographic signal is greater than the electromyographic amplitude at rest, the neurostimulation unit places the electrode patch on the sacral nerve target point; when the abdominal pressure and electromyographic signal meet the timing for defecation, but there is no defecation information, the neurostimulation unit activates the electrode patch on the sacral nerve target point for electrical stimulation. When the abdominal pressure exceeds 1.5 times the resting value ≥ 3 times within 30 seconds, but the electromyographic signal is not at the time of defecation, the nerve electrical stimulation unit activates the electrode patch set at the tibial nerve target point to stimulate it.

4. The supine defecation assistance system according to claim 1, characterized in that, The abdominal pressure sensor is a flexible array-type sensing unit, including three pressure sensing points distributed in an isosceles triangle, including two lumbar points and one subumbilical point, with each sensing point having a diameter of 6mm; the sensor substrate is made of medical-grade silicone material with a thickness of ≤0.3mm, and is attached to the skin with low-sensitivity acrylic adhesive.

5. The supine defecation assistance system according to claim 4, characterized in that, In the isosceles triangle distribution of pressure sensing points of the abdominal pressure sensor, each pressure sensing point has a built-in micro gyroscope. The main control unit is connected to the micro gyroscope to monitor the spatial attitude changes of the sensing points in real time. The weight coefficients of the three pressure sensing points are dynamically allocated according to the tilt angle.

6. The supine defecation assistance system according to claim 5, characterized in that, When the tilt angle of any pressure sensing point is within the range of 15°-30°, the weighting coefficients of the three pressure sensing points are allocated as follows: The left lumbar sensor point is tilted, the weighting coefficient of the right lumbar sensor point is 0.3, and the weighting coefficient of the subumbilical sensor point is 0.

2. The real-time measured abdominal pressure value = pressure value of the left lumbar sensor point × 0.5 + pressure value of the right lumbar sensor point × 0.3 + pressure value of the subumbilical sensor point × 0.

2. The right lumbar sensor point is tilted, and the left lumbar sensor point is symmetrically configured with a weight coefficient of 0.

3. The subumbilical sensor point has a weight coefficient of 0.

2. The real-time measured abdominal pressure value = pressure value of the left lumbar sensor point × 0.3 + pressure value of the right lumbar sensor point × 0.5 + pressure value of the subumbilical sensor point × 0.

2. The subumbilical sensing point is tilted, and the weight coefficients of the left and right lumbar sensing points are both 0.

4. The real-time measured abdominal pressure value = pressure value of the left lumbar sensing point × 0.4 + pressure value of the right lumbar sensing point × 0.4 + pressure value of the subumbilical sensing point × 0.

2.

7. The supine assisted defecation system according to claim 5, characterized in that, When the tilt angle of any pressure sensing point is greater than 30°, the weighting coefficients of the three pressure sensing points are allocated as follows; When the left side of the waist sensor point is tilted, the corresponding weight coefficient of the right side of the waist sensor point is 0.5, and the weight coefficient of the subumbilical sensor point is 0.

3. The real-time measured abdominal pressure value = pressure value of the right side of the waist sensor point × 0.5 + pressure value of the left side of the waist sensor point × 0.2 + pressure value of the subumbilical sensor point × 0.

3. When the right side of the waist sensor point is tilted, the corresponding weight coefficient of the left side of the waist sensor point is 0.5, and the weight coefficient of the subumbilical sensor point is 0.

3. The real-time measured abdominal pressure value = pressure value of the left side of the waist sensor point × 0.5 + pressure value of the right side of the waist sensor point × 0.2 + pressure value of the subumbilical sensor point × 0.

3. The subumbilical sensing point is tilted, the weight coefficient of the left lumbar sensing point is 0.45, and the weight coefficient of the right lumbar sensing point is 0.45; the real-time measured abdominal pressure value = pressure value of the left lumbar sensing point × 0.45 + pressure value of the right lumbar sensing point × 0.45 + pressure value of the subumbilical sensing point × 0.

1.

8. The supine assisted defecation system according to claim 4, characterized in that, The flexible array sensing unit also includes an annular elastic frame surrounding three pressure sensing points. The frame is made of silicone, with a width of 5mm and a height of 1.2mm, and a micro suction cup is integrated on the inner side of the frame.

9. The supine defecation assistance system according to claim 1, characterized in that, The abdominal pressure sensor and the flexible patch of electromyography electrodes are integrated with a disposable medical care pad using biodegradable hot melt adhesive.

10. The supine defecation assistance system according to claim 9, characterized in that, The surface of the nursing pad is provided with a hollowed-out positioning area that matches the pressure sensing points of the flexible array-type sensing unit, and a diamond-shaped grid embossing is provided in the waist and abdomen contact area.

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