A stoma leakage early warning system and method based on monitoring of stoma outlet displacement

Abstract

This invention relates to a stoma leakage early warning system and method based on drainage port displacement monitoring. It includes a ring-shaped stoma chassis integrating a data processing module and a displacement sensing unit, and a control app on a handheld terminal. The ring-shaped stoma chassis is installed on the outside of the stoma. A floating convex surface is flexibly connected to the center of the ring-shaped stoma chassis. Two parts of the displacement sensing unit are respectively installed on the ring-shaped stoma chassis and the floating convex surface. The floating convex surface is used to connect to the ostomy bag. The displacement sensing unit is used to detect minute displacements between the floating convex surface and the ring-shaped stoma chassis when the stoma leaks fluid and converts these minute displacements into electrical signals. The data processing module is used to convert the electrical signals into early warning signals and send them to the control app on the handheld terminal. This invention can detect abnormal displacements and trigger early warnings before leakage spreads or fully occurs, thereby buying valuable repair and treatment time for patients and effectively avoiding serious consequences such as stoma infection and stoma dysfunction.

Description

Technical Field

[0001] This invention relates to the field of stoma leakage monitoring technology, specifically a stoma leakage early warning system and method based on drainage port displacement monitoring. Background Technology

[0002] An ostomy is an opening created by surgically removing the intestines to the body surface in patients with digestive or urinary system diseases. It serves as a substitute for the anus or urethra in draining waste, and is commonly used in the treatment of rectal cancer, bladder cancer, and other diseases. Stoma leakage is a common but serious post-stomach surgery problem, leading to stoma infection and dysfunction. Traditional leakage detection devices typically only issue warnings after leakage has fully occurred, failing to detect and warn of early leakage, thus hindering prevention and repair. Multiple experiments revealed that in the early stages of fluid leakage, accumulated waste causes a slight upward relative displacement or height change in the drainage area at the center of the annular stoma base. Therefore, this paper proposes a stoma leakage early warning system and method based on drainage displacement monitoring. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this invention provides a stoma leakage early warning system and method based on outlet displacement monitoring, which uses a high-precision sensor to continuously monitor this "height" change, enabling early and accurate risk warnings before leakage spreads to the chassis edge and is perceived by the user.

[0004] To achieve the above objectives, the present invention adopts the following technical solution: A stoma leakage early warning system and method based on drainage port displacement monitoring includes a ring-shaped stoma chassis integrating a data processing module and a displacement sensing unit, and a control APP on a handheld terminal. The ring-shaped stoma chassis is installed on the outside of the patient's stoma. A floating convex surface is flexibly connected to the center of the ring-shaped stoma chassis. Two parts of the displacement sensing unit are respectively installed on the ring-shaped stoma chassis and the floating convex surface. The floating convex surface is used to connect an ostomy bag. The displacement sensing unit is used to detect the minute displacement between the floating convex surface and the ring-shaped stoma chassis when stoma leakage occurs and converts the minute displacement change into an electrical signal. A Bluetooth module is integrated on the ring-shaped stoma chassis. The data processing module is used to convert the electrical signal into an early warning signal and send it to the control APP on the handheld terminal via the Bluetooth module. The control APP on the handheld terminal is installed on the mobile receiving device. The control APP on the handheld terminal is used to push corresponding warning messages after receiving corresponding warning signals. The annular stoma chassis is also integrated with a micro vibration sensor chip. The micro vibration sensor chip is used to determine whether the patient is in a moving state by detecting the vibration of the annular stoma chassis. The micro vibration sensor chip is used to control the displacement sensing unit circuit to disconnect and thus pause monitoring when the patient is detected to be in a moving state. The micro vibration sensor chip is used to connect the displacement sensing unit circuit to start monitoring when the patient is detected to be in a calm state. After the displacement sensing unit is working, it can issue warnings in the control APP on the handheld terminal using two sets of warning thresholds according to whether the patient's upper body is upright or lying down.

[0005] Furthermore, the displacement sensing unit includes an excitation coil and a miniature magnetic core, which are respectively mounted on the annular stoma chassis and the floating convex surface. When the distance between the excitation coil and the miniature magnetic core changes, the inductance or coupling coefficient of the excitation coil changes. By detecting the change in the frequency of the LC oscillation circuit or the coil impedance, the displacement difference ΔH can be accurately calculated.

[0006] Furthermore, the displacement sensing unit includes an annular transmitting electrode and an annular receiving electrode. The annular transmitting electrode is installed inside the annular stoma chassis, and the annular receiving electrode is installed on the back of the floating convex surface. When leakage occurs, the leakage pushes up the floating convex surface, the distance D between the annular transmitting electrode and the annular receiving electrode decreases, and the capacitance value increases. The data processing module calculates the displacement difference ΔH by increasing the difference between the capacitance value and the standard capacitance value.

[0007] Furthermore, the floating convex surface is connected to the annular stoma base plate via a corrugated silicone ring, which is used to limit the floating convex surface to float within a range of 0-3mm along the axial direction of the annular stoma base plate.

[0008] Furthermore, the initial gap between the floating convex surface and the annular stoma base plate is less than 0.3 mm, and the gap surfaces are all smoothed.

[0009] A method for early warning of stoma leakage based on discharge port displacement monitoring, characterized in that, Step 1: The displacement sensing unit collects the actual displacement value Tn of the floating convex surface at a frequency of 1 Hz and sends it to the data processing module. It monitors the initial displacement value of the patient's upper body in the upright and lying positions when the patient is at rest. In the control APP on the handheld terminal, the displacement sensing unit sets two displacement reference values ​​T0 and two sets of warning thresholds in the two states based on the initial displacement values ​​of the floating convex surface in the two states. The corresponding warning threshold group is selected according to the current state of the patient's upper body. Each warning threshold group is divided into a first-level warning threshold T1, a second-level warning threshold T2, and a third-level warning threshold T3. The micro vibration sensing chip monitors whether the annular stoma chassis is in a calm state. When the annular stoma chassis is in a calm state, proceed to Step 2. When the annular stoma chassis is in a moving state, proceed to Step 4. Step 2: The data processing module calculates the difference ΔH between the actual displacement value Tn and the displacement reference value T0, and compares the difference ΔH with the first-level warning threshold T1, the second-level warning threshold T2 and the third-level warning threshold T3 one by one; Step 3: When T1 > ΔH, the system is considered to be in a safe state, and the data processing module remains silent. When T2>ΔH≥T1, it is determined to be a Level 1 warning state. The data processing module sends the corresponding warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash. When T3>ΔH≥T2, it is determined to be a level 2 warning state. The data processing module sends the corresponding warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash and the mobile receiving device to shake intermittently. When ΔH≥T3, it is determined to be a level 3 warning state. The data processing module sends the corresponding warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash and the mobile receiving device to shake strongly and continuously. Step 4: After the miniature vibration sensor chip detects vibration of the annular stoma baseplate for a certain period of time, it determines that the annular stoma baseplate and the patient are in a moving state. The miniature vibration sensor chip sends a disconnection signal to the data processing module. Upon receiving the disconnection signal, the data processing module disconnects the excitation coil circuit or the transmitting electrode circuit, and the displacement sensing unit stops displacement monitoring. When the micro vibration sensor chip detects that the annular stoma base has not vibrated for a period of time, it determines that the annular stoma base and the patient are in a calm state. The micro vibration sensor chip sends a connection signal to the data processing module. After receiving the connection signal, the data processing module connects the excitation coil circuit or the transmitting electrode circuit. The displacement sensing unit restarts displacement monitoring. At the same time, the data processing module sends a prompt signal to the control APP on the handheld terminal. After receiving the prompt signal, the control APP on the handheld terminal pushes the prompt information, the vibration device, and emits a prompt sound to the mobile receiving device, reminding the patient to reselect the warning threshold group according to the state of the patient's upper body after calming down. Step 5: Proceed to Step 2 and update the Level 1 warning threshold T1, Level 2 warning threshold T2, and Level 3 warning threshold T3 to the warning threshold group set in the previous step.

[0010] The beneficial effects of this invention are as follows: 1. Traditional leakage detection devices usually issue warnings only after leakage has fully occurred. However, this invention is based on the key discovery that "in the early stage of liquid leakage, the accumulated excrement will cause a slight upward displacement in the central drainage area of ​​the stoma base plate." Through a displacement sensing unit, it monitors the minute displacement changes between the floating convex surface and the annular stoma base plate in real time (with an accuracy of up to 0.1 mm). It can detect abnormal displacement and trigger warnings before leakage has spread or fully occurred, thereby buying valuable repair and treatment time for patients and effectively avoiding serious consequences such as stoma infection and stoma dysfunction.

[0011] 2. This invention sets three warning thresholds, combined with differentiated response modes for intermittent vibration and continuous strong vibration, to achieve a progressive warning system from "paying attention → prompting action → emergency alarm". Patients can take corresponding measures according to different levels—at the first level warning, they can choose to check and replace the device when appropriate; at the third level warning, they need to take immediate action to directly monitor the root cause of leakage (liquid accumulation), avoiding false alarms caused by sweat or humid environments from the humidity sensor.

[0012] 3. This invention employs two selectable displacement sensing schemes: one is based on the detection of inductance / impedance changes between the excitation coil and the miniature magnetic core, and the other is based on the detection of capacitance changes between the ring-shaped transmitting electrode and the ring-shaped receiving electrode. Neither scheme requires direct contact with the excrement; the displacement difference ΔH is accurately calculated through a non-contact sensing method, avoiding sensor contamination or corrosion. Simultaneously, the corrugated silicone ring limits the floating range to within 0-3mm, ensuring sufficient sensitivity while preventing misjudgments or discomfort caused by excessive displacement.

[0013] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. Attached Figure Description

[0014] Figure 1This is a flowchart of the present invention; Figure 2 This is a schematic diagram of the system of the present invention; Figure 3 A three-dimensional structural diagram of the annular stoma chassis structure; Figure 4 This is a schematic diagram showing the difference ΔH between the actual displacement value and the displacement reference value.

[0015] The components represented by the numbers in the attached diagram are as follows: 1. Circular stoma base plate; 2. Floating convex surface; 3. Corrugated silicone ring. Detailed Implementation

[0016] The principles and features of the present invention are described below with reference to the accompanying drawings. The examples given are only for explaining the present invention and are not intended to limit the scope of the present invention.

[0017] like Figure 2-3 As shown, a stoma leakage early warning system and method based on drainage port displacement monitoring includes an annular stoma base 1 integrating a data processing module and a displacement sensing unit, and a control APP on a handheld terminal. The annular stoma base 1 is installed on the outside of the patient's stoma. A floating convex surface 2 is flexibly connected to the center of the annular stoma base 1. The two parts of the displacement sensing unit are respectively installed on the annular stoma base 1 and the floating convex surface 2. The floating convex surface 2 is used to connect to the ostomy bag. The displacement sensing unit is used to detect the minute displacement between the floating convex surface 2 and the annular stoma base 1 when the stoma leaks fluid and converts the minute displacement change into an electrical signal. The annular stoma base 1 integrates a Bluetooth module. The data processing module is used to convert the electrical signal into an early warning signal and send it to the handheld terminal via the Bluetooth module. The control APP on the handheld terminal is installed on the mobile receiving device. The control APP on the handheld terminal is used to push corresponding warning messages after receiving corresponding warning signals. The annular stoma chassis also integrates a micro vibration sensor chip. The micro vibration sensor chip is used to determine whether the patient is in a moving state by detecting the vibration of the annular stoma chassis. The micro vibration sensor chip is used to control the displacement sensing unit circuit to disconnect and thus pause monitoring when the patient is detected to be in a moving state. The micro vibration sensor chip is used to connect the displacement sensing unit circuit to start monitoring when the patient is detected to be in a calm state. After the displacement sensing unit is working, it can issue warnings in the control APP on the handheld terminal using two sets of warning thresholds according to whether the patient's upper body is upright or lying flat.

[0018] Specifically, the annular stoma base 1 has an adhesive part and a module mounting part. Electronic components are integrated and installed inside the annular cavity formed by the adhesive part and the module mounting part. The adhesive part is made of medical silicone to ensure that it is skin-friendly. The module mounting part and the floating convex surface 2 are both made of medical-grade polyethylene. A button battery is installed inside the data processing module, and all power-consuming components are powered by the button battery. A Bluetooth module is installed on the annular stoma base 1. A connecting hole is opened in the center of the floating convex surface 2. A retaining ring for connecting the ostomy bag is provided at the connecting hole. The retaining ring is threaded to the ostomy bag. The ostomy bag is an existing general-purpose ostomy bag. An indicator light is also integrated on the annular stoma base 1. When the data processing module issues a warning signal, the indicator light flashes red and flashes for 5 seconds, 10 seconds and 20 seconds respectively according to the warning level.

[0019] In one embodiment, the displacement sensing unit includes an excitation coil and a miniature magnetic core. The excitation coil and the miniature magnetic core are respectively mounted on the annular stoma chassis 1 and the floating convex surface 2. The excitation coil is electrically connected to the data processing module. When the distance between the excitation coil and the miniature magnetic core changes, the inductance or coupling coefficient of the excitation coil changes. By detecting the change in the frequency of the LC oscillation circuit or the coil impedance, the displacement difference ΔH is accurately calculated.

[0020] In one embodiment, the displacement sensing unit includes an annular transmitting electrode and an annular receiving electrode. The annular transmitting electrode is installed inside the annular stoma base plate 1, and the annular receiving electrode is installed on the back of the floating convex surface 2. When leakage occurs, the leakage pushes up the floating convex surface 2, the distance D between the annular transmitting electrode and the annular receiving electrode decreases, and the capacitance value increases. The data processing module calculates the displacement difference ΔH by increasing the difference between the capacitance value and the standard capacitance value.

[0021] In one embodiment, the floating convex surface 2 is connected to the annular stoma base plate 1 by a corrugated silicone ring 3, which is used to limit the floating convex surface 2 to float within a range of 0-3mm along the axial direction of the annular stoma base plate 1 (i.e., approximately horizontally).

[0022] Specifically, the corrugated silicone ring 3 is made of medical-grade silicone to ensure that it is compatible with human skin. The corrugated silicone ring 3 is installed on the back of the annular stoma base plate 1 and the floating convex surface 2. The corrugated silicone ring 3 has good elastic deformation ability and sealing performance, which can ensure that the floating convex surface 2 produces measurable displacement under small leakage pressure, while effectively preventing the leakage of body fluid.

[0023] As one implementation, the gap between the floating convex surface 2 and the annular stoma base plate 1 is less than 0.3 mm, and the gap surfaces are all smoothed to avoid the floating convex surface 2 from having too large an up-and-down floating range, thereby affecting the displacement sensing unit's measurement of the horizontal floating distance of the floating convex surface 2.

[0024] like Figure 1 As shown, a method for early warning of stoma leakage based on discharge port displacement monitoring is characterized in that, Step 1: The displacement sensing unit collects the actual displacement value Tn of the floating convex surface 2 at a frequency of 1 Hz and sends it to the data processing module. It monitors the initial displacement value of the patient's upper body in the upright and lying positions when the patient is at rest. In the control APP on the handheld terminal, the displacement sensing unit sets two displacement reference values ​​T0 and two sets of warning thresholds in the two states based on the initial displacement values ​​of the floating convex surface 2 in the two states. The corresponding warning threshold group is selected according to the current state of the patient's upper body. Each set of warning thresholds is divided into a first-level warning threshold T1, a second-level warning threshold T2, and a third-level warning threshold T3. The micro vibration sensing chip monitors whether the annular stoma base plate is in a calm state. When the annular stoma base plate is in a calm state, proceed to step 2. When the annular stoma base plate is in a moving state, proceed to step 4. Step 2: The data processing module calculates the difference ΔH between the actual displacement value Tn and the displacement reference value T0, and compares the difference ΔH with the first-level warning threshold T1, the second-level warning threshold T2 and the third-level warning threshold T3 one by one; Step 3: When T1 > ΔH, the system is considered to be in a safe state, and the data processing module remains silent. When T2>ΔH≥T1, it is determined to be a Level 1 warning state. The data processing module sends the corresponding warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash. When T3>ΔH≥T2, it is determined to be a level 2 warning state. The data processing module sends the corresponding warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash and the mobile receiving device to shake intermittently. When ΔH≥T3, it is determined to be a level 3 warning state. The data processing module sends the corresponding warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash and the mobile receiving device to shake strongly and continuously. Step 4: After the miniature vibration sensor chip detects vibration of the annular stoma baseplate for a certain period of time, it determines that the annular stoma baseplate and the patient are in a moving state. The miniature vibration sensor chip sends a disconnection signal to the data processing module. Upon receiving the disconnection signal, the data processing module disconnects the excitation coil circuit or the transmitting electrode circuit, and the displacement sensing unit stops displacement monitoring. When the micro vibration sensor chip detects that the annular stoma base has not vibrated for a period of time, it determines that the annular stoma base and the patient are in a calm state. The micro vibration sensor chip sends a connection signal to the data processing module. After receiving the connection signal, the data processing module connects the excitation coil circuit or the transmitting electrode circuit. The displacement sensing unit restarts displacement monitoring. At the same time, the data processing module sends a prompt signal to the control APP on the handheld terminal. After receiving the prompt signal, the control APP on the handheld terminal pushes the prompt information, the vibration device, and emits a prompt sound to the mobile receiving device, reminding the patient to reselect the warning threshold group according to the state of the patient's upper body after calming down. Step 5: Proceed to Step 2 and update the Level 1 warning threshold T1, Level 2 warning threshold T2, and Level 3 warning threshold T3 to the warning threshold group set in the previous step.

[0025] The workflow of this invention: Step 1: Install the annular stoma base plate 1 and the floating convex surface 2 on the outside of the stoma and connect them to the control APP on the handheld terminal via Bluetooth module. The displacement sensing unit collects the actual displacement value Tn of the floating convex surface 2 at a frequency of 1 Hz and sends it to the data processing module. The data processing module collects the data sent by the displacement sensing unit within 2 minutes, calculates the average value as the initial displacement value, and sends it to the control APP on the handheld terminal. The initial displacement values ​​of the patient's upper body in upright and lying positions are calculated separately. In the control APP on the handheld terminal, the displacement sensing unit is set to two values ​​in the two states based on the initial displacement values ​​of the floating convex surface 2 in the two states. The displacement reference value T0 and two sets of warning thresholds are used. The corresponding warning threshold group is selected according to the current state of the patient's upper body. Each set of warning thresholds is divided into a first-level warning threshold T1, a second-level warning threshold T2 and a third-level warning threshold T3. The micro vibration sensor chip monitors whether the annular stoma base plate is in a calm state. When the annular stoma base plate is in a calm state, step 2 is performed. When the annular stoma base plate is in a moving state, step 4 is performed. When the patient's upper body is in an upright state, T1=0.5mm, T2=1.2mm, and T3=2mm. When the patient's upper body is in a supine state, T1=0.3mm, T2=0.8mm, and T3=1.2mm. Step 2: The data processing module calculates the difference ΔH between the actual displacement value Tn and the displacement reference value T0, and compares the difference ΔH with the first-level warning threshold T1, the second-level warning threshold T2 and the third-level warning threshold T3 one by one; Step 3: When T1 > ΔH, the system is considered to be in a safe state, and the data processing module remains silent. When T2>ΔH≥T1, it is determined to be a Level 1 warning state. The data processing module sends the corresponding warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash. At the same time, the indicator light flashes for 5 seconds. When T3>ΔH≥T2, it is determined to be a level 2 warning state. The data processing module sends a warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash and the mobile receiving device to shake intermittently. At the same time, the indicator light flashes for 10 seconds. When ΔH≥T3, it is determined to be a level 3 warning state. The data processing module sends the corresponding warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash and the mobile receiving device to shake strongly and continuously. At the same time, the indicator light flashes for 20 seconds. Step 4: After the micro vibration sensor chip detects vibration of the annular stoma chassis for one minute, it determines that the annular stoma chassis is in a moving state. The micro vibration sensor chip sends a disconnection signal to the data processing module. Upon receiving the disconnection signal, the data processing module disconnects the excitation coil circuit or the transmitting electrode circuit, and the displacement sensing unit stops displacement monitoring. When the micro vibration sensor chip detects that the annular stoma base has not vibrated within one minute, it determines that the annular stoma base is in a calm state. The micro vibration sensor chip sends a connection signal to the data processing module. After receiving the connection signal, the data processing module connects the excitation coil circuit or the transmitting electrode circuit. The displacement sensing unit restarts displacement monitoring. At the same time, the data processing module sends a prompt signal to the control APP on the handheld terminal. After receiving the prompt signal, the control APP on the handheld terminal pushes the prompt information, vibrates the device, and emits a prompt sound to the mobile receiving device, reminding the patient to reselect the warning threshold group according to the state of the patient's upper body after calming down. Step 5: Proceed to Step 2 and update the Level 1 warning threshold T1, Level 2 warning threshold T2, and Level 3 warning threshold T3 to the warning threshold group set in the previous step.

[0026] The above description provides examples of the preferred embodiments of the present invention. Parts not detailed herein are common knowledge to those skilled in the art. The scope of protection of the present invention is determined by the claims. Any equivalent modifications based on the technical teachings of the present invention are also within the scope of protection of the present invention.

Claims

1. A stoma leakage early warning system based on discharge port displacement monitoring, characterized in that, The device includes an annular stoma base (1) integrating a data processing module and a displacement sensing unit, and a control APP on a handheld terminal. The annular stoma base (1) is installed on the outside of the patient's stoma. A floating convex surface (2) is flexibly connected to the center of the annular stoma base (1). The two parts of the displacement sensing unit are respectively installed on the annular stoma base (1) and the floating convex surface (2). The floating convex surface (2) is used to connect the stoma bag. The displacement sensing unit is used to detect the minute displacement between the floating convex surface (2) and the annular stoma base (1) when the stoma leaks fluid and converts the minute displacement change into an electrical signal. The annular stoma base (1) integrates a Bluetooth module. The data processing module is used to convert the electrical signal into an early warning signal and send it to the control APP on the handheld terminal via the Bluetooth module. The control APP on the handheld terminal is installed on the mobile receiving device. The control APP on the handheld terminal is used to push corresponding warning messages after receiving corresponding warning signals. The annular stoma chassis also integrates a micro vibration sensor chip. The micro vibration sensor chip is used to determine whether the patient is in a moving state by detecting the vibration of the annular stoma chassis. The micro vibration sensor chip is used to control the displacement sensing unit circuit to disconnect and thus pause monitoring when the patient is detected to be in a moving state. The micro vibration sensor chip is used to connect the displacement sensing unit circuit to start monitoring when the patient is detected to be in a calm state. After the displacement sensing unit is working, it can issue warnings in the control APP on the handheld terminal using two sets of warning thresholds according to whether the patient's upper body is upright or lying down.

2. The stoma leakage early warning system based on discharge port displacement monitoring according to claim 1, characterized in that, The displacement sensing unit includes an excitation coil and a micro magnetic core. The excitation coil and the micro magnetic core are respectively mounted on the annular ostomy chassis (1) and the floating convex surface (2). When the distance between the excitation coil and the micro magnetic core changes, the inductance or coupling coefficient of the excitation coil changes. By detecting the change in the frequency of the LC oscillation circuit or the coil impedance, the displacement difference ΔH is accurately calculated.

3. The stoma leakage early warning system based on discharge port displacement monitoring according to claim 1, characterized in that, The displacement sensing unit includes an annular transmitting electrode and an annular receiving electrode. The annular transmitting electrode is installed inside the annular stoma base (1), and the annular receiving electrode is installed on the back of the floating convex surface (2). When leakage occurs, the leakage pushes up the floating convex surface (2), the distance D between the annular transmitting electrode and the annular receiving electrode decreases, and the capacitance value increases. The data processing module calculates the displacement difference ΔH by increasing the difference between the capacitance value and the standard capacitance value.

4. The stoma leakage early warning system based on discharge port displacement monitoring according to claim 1, characterized in that, The floating convex surface (2) is connected to the annular stoma base plate (1) by a corrugated silicone ring (3), which is used to restrict the floating convex surface (2) from floating within a range of 0-3mm along the axial direction of the annular stoma base plate (1).

5. The stoma leakage early warning system based on discharge port displacement monitoring according to claim 1, characterized in that, The initial gap between the floating convex surface (2) and the annular stoma base plate (1) is less than 0.3 mm, and the gap surfaces are all smoothed.

6. A method for early warning of stoma leakage based on discharge port displacement monitoring, characterized in that, Step 1: The displacement sensing unit collects the actual displacement value Tn of the floating convex surface (2) at a frequency of 1 Hz and sends it to the data processing module. It monitors the initial displacement value of the patient's upper body in the upright and lying positions when the patient is calm. In the control APP on the handheld terminal, the displacement sensing unit sets two displacement reference values ​​T0 and two sets of warning thresholds in the two states according to the initial displacement values ​​of the floating convex surface (2) in the two states. The corresponding warning threshold group is selected according to the current state of the patient's upper body. Each set of warning thresholds is divided into a first-level warning threshold T1, a second-level warning threshold T2 and a third-level warning threshold T3. The micro vibration sensing chip monitors whether the annular stoma chassis is in a calm state. When the annular stoma chassis is in a calm state, Step 2 is performed. When the annular stoma chassis is in a moving state, Step 4 is performed. Step 2: The data processing module calculates the difference ΔH between the actual displacement value Tn and the displacement reference value T0, and compares the difference ΔH with the first-level warning threshold T1, the second-level warning threshold T2 and the third-level warning threshold T3 one by one; Step 3: When T1 > ΔH, the system is considered to be in a safe state, and the data processing module remains silent. When T2>ΔH≥T1, it is determined to be a Level 1 warning state. The data processing module sends the corresponding warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash. When T3>ΔH≥T2, it is determined to be a level 2 warning state. The data processing module sends the corresponding warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash and the mobile receiving device to shake intermittently. When ΔH≥T3, it is determined to be a level 3 warning state. The data processing module sends the corresponding warning signal to the control APP on the handheld terminal. After receiving the warning signal, the control APP on the handheld terminal pushes the corresponding warning message and controls the screen to flash and the mobile receiving device to shake strongly and continuously. Step 4: After the miniature vibration sensor chip detects vibration of the annular stoma baseplate for a certain period of time, it determines that the annular stoma baseplate and the patient are in a moving state. The miniature vibration sensor chip sends a disconnection signal to the data processing module. Upon receiving the disconnection signal, the data processing module disconnects the excitation coil circuit or the transmitting electrode circuit, and the displacement sensing unit stops displacement monitoring. When the micro vibration sensor chip detects that the annular stoma base has not vibrated for a period of time, it determines that the annular stoma base and the patient are in a calm state. The micro vibration sensor chip sends a connection signal to the data processing module. After receiving the connection signal, the data processing module connects the excitation coil circuit or the transmitting electrode circuit. The displacement sensing unit restarts displacement monitoring. At the same time, the data processing module sends a prompt signal to the control APP on the handheld terminal. After receiving the prompt signal, the control APP on the handheld terminal pushes the prompt information, the vibration device, and emits a prompt sound to the mobile receiving device, reminding the patient to reselect the warning threshold group according to the state of the patient's upper body after calming down. Step 5: Proceed to Step 2 and update the Level 1 warning threshold T1, Level 2 warning threshold T2, and Level 3 warning threshold T3 to the warning threshold group set in the previous step.

Images