Ileum fistulization device with stoma monitoring function

Abstract

The invention relates to the technical field of fistulization devices, in particular to an ileum fistulization device with a stoma monitoring function, which comprises a fixed chassis, a covering assembly and a monitoring assembly. The monitoring assembly comprises a fixing ring; an electrode plate and a photoelectric sensor are arranged at the bottom of the fixing ring; an electric control assembly is arranged on the fixing ring and electrically connected with the electrode plates and the photoelectric sensor through wires. According to the invention, leakage monitoring and ischemia early warning functions are integrated, tissue impedance can be measured through the electrode slice, and leakage can be accurately identified. Meanwhile, the photoelectric sensor is used for monitoring the blood oxygen saturation degree, the oppression ischemia condition can be found in time, and stoma tissue necrosis is prevented. According to the invention, seepage and ischemia states can be monitored in advance according to monitoring data, and the problem that detection and alarm can only be carried out after certain serious consequences are generated by a transmission monitoring device is avoided. The skin injury and infection risk caused by leakage or ischemia of a patient can be remarkably reduced, and the use comfort and life quality of the patient are improved.

Description

Technical Field

[0001] This invention relates to the field of stoma device technology, specifically an ileostomy device with stoma monitoring function. Background Technology

[0002] Traditional ileostomy devices primarily rely on the physical isolation between the baseplate adhesive and the surrounding skin to collect excrement, lacking the ability to actively monitor complications. Clinically, this presents the following problems: 1. Delayed leakage warning: By the time excrement leaks to the skin-baseplate interface, it often causes skin irritation (such as dermatitis or ulcers), increasing the risk of infection and the nursing burden; 2. Difficulty in assessing ischemia risk: Early symptoms of stoma ischemia caused by baseplate compression or abnormal mucosal blood supply are often subtle, and by the time visible mucosal necrosis is observed, treatment has been delayed.

[0003] While existing technologies have attempted to integrate single sensors, such as humidity sensors, they have the following limitations: 1. The detection process cannot distinguish the nature of exudate, for example, it cannot avoid interference caused by sweat, leading to false alerts and other problems; 2. There is a lack of continuous monitoring of tissue blood oxygenation, making it difficult to assess the risk of compressive ischemia; 3. The sensor layout is not optimized, and it is easily affected by changes in body position, which can interfere with the accuracy of monitoring. Summary of the Invention

[0004] The present invention aims to provide an ileostomy device with stoma monitoring function to achieve early warning of leakage and assessment of ischemia risk.

[0005] To solve the above-mentioned technical problems, the present invention provides the following technical solution: An ileostomy device with stoma monitoring function includes a fixed base, a covering component, and a monitoring component; The fixed chassis is provided with a first opening, and the first opening is provided with a snap-fit ​​groove; The bottom of the cover assembly is provided with a snap-fit ​​part that mates with the snap-fit ​​groove, and the cover assembly is provided with a second opening for exposing the stoma. The monitoring component includes a fixing ring, with an electrode plate and a photoelectric sensor at the bottom of the fixing ring; an electronic control component is provided on the fixing ring, and the electronic control component is electrically connected to the electrode plate and the photoelectric sensor through wires.

[0006] As an improvement, the number of electrode plates is four, arranged in a circumferential array on the fixed ring; The photoelectric sensor consists of an LED green light and a light receiving component, and the fixing ring is equipped with two LED green lights and a light receiving component.

[0007] As an improvement, the LED green light and light receiving component are encapsulated in transparent medical silicone to ensure biocompatibility and waterproof performance.

[0008] As an improvement, the monitoring component is provided with a non-woven fabric pad at the bottom, and a third opening corresponding to the second opening is provided at the center of the non-woven fabric pad, and a through hole is provided at the position of the corresponding photoelectric sensor.

[0009] As an improvement, the outer side of the fixed chassis is provided with an adhesive part, the adhesive part is provided with a mounting base, the electronic control component is provided on the mounting base and is detachably connected to the mounting base.

[0010] As an improvement, the snap-fit ​​slot has a fourth opening on the side near the mounting base, through which the wire passes and connects to the electronic control component.

[0011] As an improvement, the electronic control assembly includes a housing, and the housing contains: Impedance detection module, used to periodically measure the tissue resistance between adjacent electrode plates; The blood oxygen monitoring module is used to receive signals from the photoelectric sensor and calculate subcutaneous blood oxygen saturation. The wireless communication module is used to transmit monitoring data to an external terminal in real time. The alarm module triggers an alarm when the resistance value is lower than a preset threshold or when the blood oxygen saturation continues to decline.

[0012] The present invention also discloses a method for ostomy monitoring, comprising the following steps: S1. Establish a basic impedance matrix by cyclically measuring tissue impedance in pairs using four electrode pads; S2. When the impedance between any adjacent electrode plates drops by more than 30-60%, leakage is determined to have occurred, and an alarm is triggered. S3. The LED green light emits high-frequency green light, and the reflected light intensity is detected by the light receiving component to calculate the hemoglobin absorption rate. S4. When blood oxygen saturation drops by more than 15% in three consecutive tests, a compression ischemia warning is triggered.

[0013] S5. Generate different alarm codes for different conditions of effusion and compression ischemia, and transmit the alarm codes to the host computer via the wireless communication module.

[0014] As an improvement, step S2 sets up a dynamic compensation algorithm, including: Record the baseline impedance fluctuation range during the patient's activity, exclude instantaneous impedance changes caused by changes in body position, and confirm the leakage alarm only when the impedance continues to decrease for more than 120 seconds.

[0015] As an improvement, a dual-wavelength correction method is used in step S3: Simultaneously detect the reflected light intensity at wavelengths of 470nm and 530nm; calculate the actual blood oxygen value by the absorption ratio of hemoglobin at 470nm / 530nm.

[0016] The advantages of this invention are: 1. This invention integrates leakage monitoring and ischemia early warning functions. It can accurately identify leakage by measuring tissue impedance using electrode pads. Simultaneously, it utilizes a photoelectric sensor to monitor blood oxygen saturation, enabling timely detection of compression-induced ischemia and preventing stoma tissue necrosis. This invention can monitor leakage and ischemia in advance based on monitoring data, avoiding the problem of transmission monitoring devices only detecting and alarming after serious consequences have occurred. This invention can significantly reduce the risk of skin damage and infection caused by leakage or ischemia in patients, improving patient comfort and quality of life.

[0017] 2. The device of the present invention has the advantage of simple structure, wherein the monitoring components can be reused. The fixed chassis and cover components can be made of low-cost disposable medical materials, which can effectively reduce usage costs while ensuring monitoring effectiveness.

[0018] 3. This invention employs a dynamic compensation algorithm and a dual-wavelength correction method, significantly improving monitoring accuracy. The dynamic compensation algorithm eliminates instantaneous impedance fluctuations caused by changes in patient position, ensuring the reliability of leakage alarms; the dual-wavelength correction method accurately calculates blood oxygen levels by simultaneously detecting reflected light intensity at wavelengths of 470nm and 530nm, avoiding errors associated with single-wavelength detection and providing a more accurate basis for clinical diagnosis.

[0019] 4. The device of this invention is equipped with a wireless communication module, which can transmit alarm codes to the host computer in real time, realizing remote monitoring and data sharing. Medical staff can monitor the patient's stoma status anytime and anywhere, respond promptly and take measures, greatly improving nursing efficiency and quality, ensuring patient safety, and is especially suitable for long-term care and telemedicine scenarios. Attached Figure Description

[0020] Figure 1 This is a structural diagram of an ileostomy device with stoma monitoring function in Example 1.

[0021] Figure 2 This is an exploded view of an ileostomy device with stoma monitoring function in Example 1.

[0022] Figure 3 This is a structural diagram of the fixed base plate in an ileostomy device with stoma monitoring function in Example 1.

[0023] Figure 4 This is a structural diagram of the covering component in an ileostomy device with stoma monitoring function in Example 1.

[0024] Figure 5 This is a structural diagram of the locking groove in an ileostomy device with stoma monitoring function in Example 1.

[0025] Figure 6 This is an exploded view of the bottom of an ileostomy device with stoma monitoring function in Example 1.

[0026] Figure 7 This is a structural diagram of the fixing ring in an ileostomy device with stoma monitoring function in Example 1.

[0027] Figure 8 This is a structural diagram of the LED green light in an ileostomy device with stoma monitoring function in Example 1.

[0028] The image shows: 1. Fixed chassis; 2. Cover assembly; 3. Monitoring assembly; 11. First opening; 12. Snap-fit ​​groove; 21. Snap-fit ​​part; 22. Second opening; 31. Fixing ring; 32. Electrode sheet; 33. Photoelectric sensor; 34. Electronic control assembly; 35. Wire; 331. LED green light; 332. Light receiving assembly; 4. Transparent medical silicone; 5. Non-woven fabric pad; 51. Third opening; 52. Through hole; 6. Adhesive part; 61. Mounting base; 121. Fourth opening. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0030] Example 1 This embodiment discloses an ileostomy device with stoma monitoring function, such as Figure 1 and Figure 2 As shown, it includes a fixed chassis 1, a cover assembly 2, and a monitoring assembly 3.

[0031] The fixed chassis 1 is provided with a first opening 11, and the first opening 11 is provided with a snap-fit ​​groove 12.

[0032] The bottom of the cover assembly 2 is provided with a snap-fit ​​part 21 that mates with the snap-fit ​​groove 12, and the cover assembly 2 is provided with a second opening 22 for exposing the stoma. The cover assembly 2 can be fitted with the fixed base 1 through the snap-fit ​​structure to ensure the stability and sealing of the device, effectively prevent leakage, and improve the patient's comfort. At the same time, the cover assembly 2 facilitates the observation and care of the stoma, reduces irritation to the skin around the stoma, lowers the risk of infection, and facilitates operation and monitoring by medical staff.

[0033] The monitoring component 3 includes a fixing ring 31, with an electrode plate 32 and a photoelectric sensor 33 at the bottom of the fixing ring 31; an electronic control component 34 is provided on the fixing ring 31, and the electronic control component 34 is electrically connected to the electrode plate 32 and the photoelectric sensor 33 through a wire 35.

[0034] There are four electrode plates 32 arranged in a circular array on the fixing ring 31; the photoelectric sensor 33 consists of an LED green light 331 and a light receiving component 332, and the fixing ring 31 is provided with two LED green lights 331 and a light receiving component 332.

[0035] The LED green light 331 and the light receiving component 332 are encapsulated in transparent medical silicone 4 to ensure biocompatibility and waterproof performance.

[0036] The monitoring component 3 has a non-woven fabric pad 5 at its lower part. The center of the non-woven fabric pad 5 has a third opening 51 corresponding to the second opening 22, and a through hole 52 at the corresponding position of the photoelectric sensor 33. The outer side of the fixed base 1 has an adhesive part 6, on which a mounting base 61 is provided. The electronic control component 34 is mounted on the mounting base 61 and is detachably connected to it. The electronic control component 34 can be magnetically attracted to the mounting base 61 by a strong magnet, or it can be mounted on the electronic control component 34 by a snap-fit ​​structure. The snap-fit ​​structure can use existing conventional snap-fits, serving only to fix the electronic control component 34, and will not be described further here.

[0037] The slot 12 has a fourth opening 121 on the side near the mounting base 61, through which the wire 35 passes and is connected to the electronic control assembly 34.

[0038] The electronic control assembly 34 includes a housing, and the housing contains: Impedance detection module, used to periodically measure the tissue resistance between adjacent electrode plates; The blood oxygen monitoring module is used to receive signals from the photoelectric sensor and calculate subcutaneous blood oxygen saturation. The wireless communication module is used to transmit monitoring data to an external terminal in real time. The alarm module triggers an alarm when the resistance value is lower than a preset threshold or when the blood oxygen saturation continues to decline. The power module is used to provide power.

[0039] The present invention also discloses a method for ostomy monitoring, comprising the following steps: S1. The tissue impedance is measured in pairs using four electrode plates to establish a basic impedance matrix.

[0040] Four electrode pads 32 on the fixing ring 31 are evenly distributed around the stoma. During testing, all possible pairwise combinations of electrode pads are first listed: (electrode pad 1, electrode pad 2), (electrode pad 1, electrode pad 3), (electrode pad 1, electrode pad 4), (electrode pad 2, electrode pad 3), (electrode pad 2, electrode pad 4), and (electrode pad 3, electrode pad 4). Determining all possible measurement combinations provides a clear sequence for subsequent cyclic measurements.

[0041] During the measurement, the first electrode combination (electrode 1, electrode 2) was selected. A weak current signal was applied to electrode 1 through the electronic control component, while the voltage signal at electrode 2 was measured simultaneously. The tissue impedance Z was calculated according to Ohm's law. 12 Then, the next electrode pair is measured sequentially, and the above measurement process is repeated. Through cyclic measurements, the tissue impedance values ​​between all electrode pairs are obtained, providing data support for the subsequent matrix construction.

[0042] The measured impedance value Z 12 Z 13 …Z 34 The electrodes are arranged in the order they are combined to form a symmetrical matrix. Setting the diagonal elements of the matrix to zero yields the fundamental impedance matrix. This matrix format allows for the systematic storage and representation of tissue impedance data, facilitating subsequent analysis and processing and providing fundamental data support for the monitoring and assessment of tissue condition.

[0043] S2. When the impedance between any adjacent electrode plates drops by more than 30-60%, leakage is determined to have occurred, and an alarm is triggered.

[0044] During use, the electronic control unit continuously monitors the impedance values ​​between each electrode assembly. It compares the currently measured impedance value with the initial impedance value in the base impedance matrix. A leak is identified when the impedance value between any adjacent electrode drops by more than 30-60%.

[0045] This step introduces a dynamic compensation algorithm. Specifically, it records the baseline impedance fluctuation range during the patient's activity, excludes instantaneous impedance changes caused by changes in body position, and only confirms a leakage alarm when the impedance continues to decrease for more than 120 seconds.

[0046] Through the above steps, real-time monitoring of the tissue impedance around the stoma can be achieved, and an alarm can be issued in time when leakage occurs, ensuring the safety and comfort of the patient.

[0047] The S3 LED green light emits high-frequency green light, and the reflected light intensity is detected by the light receiving component to calculate the hemoglobin absorption rate.

[0048] The specific method is as follows: The LED green light 331 is controlled by the electronic control component 34 to periodically emit high-frequency green light. The frequencies of the green light are 470nm and 530nm. When the green light emitted by the LED green light 331 shines on the tissue around the stoma, part of the green light is absorbed by the tissue and part of the green light is reflected back.

[0049] The light receiving component 332 detects the intensity of green light reflected from the tissue. The light receiving component 332 converts the received light signal into an electrical signal and transmits it to the electronic control component 34. The electronic control component 34 acquires the electrical signal transmitted by the light receiving component 332 and records the reflected light intensity data.

[0050] This step uses a dual-wavelength correction method: Simultaneously detect the reflected light intensity at wavelengths of 470nm and 530nm; calculate the actual blood oxygen value by the absorption ratio of hemoglobin at 470nm / 530nm.

[0051] The reflected light intensity ratio and absorptivity are calculated sequentially. Then, based on standard samples with known blood oxygen levels, a calibration curve is established between the absorptivity and blood oxygen value. The relationship between the absorptivity and blood oxygen value is determined using experimental data. The corresponding blood oxygen value is then located using the calibration curve based on the calculated absorptivity A. The calculated blood oxygen value is stored in the electronic control component 34 for further analysis.

[0052] S4. When blood oxygen saturation drops by more than 15% in three consecutive tests, a compression ischemia warning is triggered.

[0053] If blood oxygen levels drop abnormally, it may indicate tissue hypoxia or poor blood circulation. A drop of more than 15% in three consecutive tests will trigger a warning for compression ischemia.

[0054] S5. Generate different alarm codes for different conditions of effusion and compression ischemia, and transmit the alarm codes to the host computer via the wireless communication module.

[0055] By generating different alarm codes, the system accurately distinguishes between effusion and compression ischemia, avoiding misdiagnosis and ensuring that medical staff can quickly take targeted measures. Simultaneously, the alarm codes are transmitted to a host computer in real time via a wireless communication module, enabling remote monitoring, improving nursing efficiency, and ensuring patient safety.

[0056] The above are merely preferred embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. An ileostomy device with stoma monitoring function, characterized in that, The fixed base plate, the covering assembly and the monitoring assembly are included. The first opening is arranged on the fixed base plate, and the clamping groove is arranged on the first opening. The clamping part matched with the clamping groove is arranged at the bottom of the covering assembly, and the second opening for exposing the stoma is arranged on the covering assembly. The fixed ring is included in the monitoring assembly, and the electrode sheet and the photoelectric sensor are arranged at the bottom of the fixed ring.

2. The ileostomy device having a stoma monitoring function according to claim 1, characterized by, The number of the electrode sheets is four, and the electrode sheets are arranged in a circumferential array on the fixed ring. The photoelectric sensor is composed of the LED green light and the light receiving assembly, and the fixed ring is provided with two LED green lights and light receiving assemblies.

3. The ileostomy device having a stoma monitoring function according to claim 1, characterized by, The LED green light and the light receiving assembly are encapsulated in the transparent medical silicone, so as to ensure the biocompatibility and waterproof performance.

4. The ileostomy device having a stoma monitoring function according to claim 1, characterized by The non-woven fabric pad is arranged at the lower part of the monitoring assembly, the third opening corresponding to the second opening is arranged at the central position of the non-woven fabric pad, and the through hole is arranged at the position corresponding to the photoelectric sensor.

5. The ileostomy device having a stoma monitoring function according to claim 1, wherein The sticking part is arranged on the outer side of the fixed base plate, the mounting seat is arranged on the sticking part, the electric control assembly is arranged on the mounting seat, and the electric control assembly is detachably connected with the mounting seat.

6. The ileostomy device having a stoma monitoring function according to claim 1, wherein The fourth opening is arranged on the side of the clamping groove close to the mounting seat, the lead wire passes through the fourth opening and is connected with the electric control assembly.

7. The ileostomy device having a stoma monitoring function according to claim 1, wherein The electric control assembly includes a shell, and the shell is internally provided with: The impedance detection module is used for periodically measuring the tissue resistance value between adjacent electrode sheets. The blood oxygen monitoring module is used for receiving the signal of the photoelectric sensor and calculating the subcutaneous blood oxygen saturation. The wireless communication module is used for transmitting the monitoring data to the external terminal in real time. The alarm module is triggered when the resistance value is lower than the preset threshold or the blood oxygen saturation continuously decreases.

8. An ostomy monitoring method based on the device of claim 7, characterized by The method includes the following steps: S1. The tissue impedance is measured by two-by-two circulation of the four electrode sheets to establish a basic impedance matrix. S2. When the impedance between any adjacent electrode sheets decreases by more than 30-60%, it is determined that leakage occurs, and an alarm is triggered. S3. The LED green light emits high-frequency green light, and the reflected light intensity is detected through the light receiving assembly to calculate the hemoglobin absorption rate. S4. When the blood oxygen saturation decreases by more than 15% for three consecutive times, an ischemia warning is triggered. S5. Different alarm codes are generated for the leakage condition and the ischemia condition, and the alarm codes are transmitted to the upper computer through the wireless communication module.

9. The stoma monitoring method according to claim 8, characterized in that, The dynamic compensation algorithm is set in step S2, including: The baseline impedance fluctuation range when the patient is active is recorded, the instantaneous impedance change caused by body position change is excluded, and only when the impedance continuously decreases for more than 120 seconds, the leakage alarm is confirmed.

10. The stoma monitoring method of claim 8, wherein, The double-wavelength correction method is adopted in step S3: The reflected light intensity under 470nm and 530nm wavelengths is synchronously detected; and the actual blood oxygen value is calculated through the absorption ratio of hemoglobin at 470nm / 530nm.

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