An intelligent monitoring and leakage early warning nursing device for urological postoperative stoma
Patent Information
- Application Number
- CN202611240446.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-08-17
- Publication Date
- 2026-10-27
AI Technical Summary
[0017]1.本发明通过柔性离子传感电极与皮肤接触,实时监测离子浓度,能够在渗漏第一时间发现异常,并准确区分尿液与汗液,解决了现有技术依赖患者体感发现渗漏的滞后性问题。且光谱监测组件采用透射式光路,多波长LED光源与光电探测器配合,可实时检测尿液颜色和浊度,实现对镜下血尿的早期预警。
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Figure CN122973197A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, specifically to an intelligent monitoring and leakage early warning nursing device for postoperative stoma in urology. Background Technology
[0002] A urostomy is a medical procedure performed to address partial loss of bowel or bladder function due to disease or injury. It involves creating an artificial passage in the abdomen to allow waste to drain from the body. Post-operatively, a stoma bag is attached to the stoma to collect urine. Currently, widely used stoma care devices in clinical practice mainly consist of a one-piece or two-piece adhesive baseplate and a stoma bag. The adhesive baseplate is attached to the skin around the stoma using hydrocolloid or silicone, while the stoma bag is attached to the baseplate for urine collection.
[0003] However, peristaltic irritant dermatitis is the most common complication after urostomy, with an incidence rate as high as 30% to 50%. The root cause of this complication is the continuous discharge of urine from the stoma. The urea, uric acid, and electrolytes in the urine decompose on the skin surface, producing ammonia-like substances, which keeps the skin around the stoma in a high-humidity, high-pH maceration environment for a long time. Even without obvious leakage, the humidity of the microenvironment under the adhesive baseplate is significantly higher than that of normal skin. This continuous high-humidity state gradually damages the skin barrier function, leading to maceration and peeling of the stratum corneum, which in turn causes local redness, swelling, itching, and pain, and in severe cases, even skin ulceration and infection.
[0004] Furthermore, the stoma morphology undergoes dynamic changes during the edema and de-edema phases post-surgery, and daily activities can easily cause minor displacement between the adhesive base and the skin, making micro-leakage highly likely. However, existing stoma care devices rely entirely on the patient's sensation or visual observation to detect leakage. This passive detection method has a significant lag; by the time the patient feels discomfort, urine has often already caused substantial damage to the skin, severely impacting the patient's post-operative quality of life. Therefore, designing an intelligent monitoring and leakage early warning device for post-urological stoma care is particularly important. Summary of the Invention
[0005] The purpose of this invention is to provide an intelligent monitoring and leakage early warning nursing device for postoperative stoma in urology, which effectively solves the problems mentioned in the background art.
[0006] To achieve the above objectives, the present invention provides the following technical solution.
[0007] A smart monitoring and leakage early warning nursing device for postoperative stoma in urology includes: an adhesive base plate, adhesive layers on both the upper and lower sides of the adhesive base plate, a first through hole in the middle of the adhesive base plate, and multiple clearance notches arranged in a ring array around the first through hole on the adhesive base plate. The silicone disk has a second through hole in the middle. Multiple flexible ion sensing electrodes are arranged in a ring array around the second through hole on the silicone disk. The multiple flexible ion sensing electrodes are arranged one-to-one with multiple clearance notches. A ring-shaped cover is set on a silicone disc, and a spectral monitoring component and a humidity sensor are respectively installed on the inner wall of the ring-shaped cover; A humidity regulating mechanism is located on the outside of the annular cover and is used to regulate the humidity inside the annular cover. The control module is located on the surface of the silicone disc and is electrically connected to the flexible ion sensing electrode, the spectral monitoring component, the humidity sensor, and the humidity adjustment mechanism.
[0008] Furthermore, the spectral monitoring component includes two first housings symmetrically arranged on the annular cover, and the first housings are in communication with the interior of the annular cover; A multi-wavelength LED light source is installed inside the first housing on one side, and a photodetector is installed inside the first housing on the other side. Both ends of the first housing are provided with light-transmitting windows that are flush with the inner wall of the annular cover.
[0009] Furthermore, the humidity control mechanism includes a hot air device mounted on the surface of the silicone disc, the output end of which is connected to an air inlet pipe, and the end of the air inlet pipe is connected to an annular cover. The surface of the annular cover is connected to an air outlet pipe, and valves are installed on both the air inlet and outlet pipes.
[0010] Furthermore, the air inlet duct is tangentially connected to the annular shroud.
[0011] Furthermore, the hot air device includes a second housing mounted on the surface of the silicone disc, with a fan and an electric heating wire disposed inside the second housing. The electric heating wire is disposed between the fan and the air inlet pipe, and a filter is disposed at the air inlet end of the second housing.
[0012] Furthermore, a temperature sensor is installed inside the air inlet duct, and the temperature sensor is electrically connected to the control module.
[0013] Furthermore, a positioning ring is provided on the first through hole, and the diameter of the positioning ring is adapted to the inner diameter of the second through hole.
[0014] Furthermore, it also includes straps, both ends of which are equipped with Velcro ties that stick together, and connecting buckles on both sides of the outer surface of the ring cover.
[0015] Furthermore, the annular cover has a flared structure with a smaller diameter on the side closer to the silicone disc and a larger diameter on the side farther from the silicone disc.
[0016] Compared with the prior art, the beneficial effects of the present invention are as follows.
[0017] 1. This invention uses a flexible ion-sensing electrode that contacts the skin to monitor ion concentration in real time, enabling the detection of abnormalities at the first sign of leakage and accurately distinguishing between urine and sweat. This solves the problem of the lag in existing technologies that rely on the patient's sensory perception to detect leakage. Furthermore, the spectral monitoring component employs a transmission optical path, with multi-wavelength LED light sources and photodetectors working together to detect urine color and turbidity in real time, achieving early warning of microscopic hematuria.
[0018] 2. This invention achieves active intervention in the stoma microenvironment through a humidity regulation mechanism. When the humidity sensor detects excessively high humidity, the patient can use a hot air device to deliver dry, hot air into the annular hood, fundamentally solving the dermatitis problem caused by the skin being in a high-humidity environment for a long time.
[0019] 3. This invention creates a swirling airflow by tangentially connecting the air inlet pipe to the annular cover, which not only improves drying efficiency but also avoids direct airflow onto the stoma, preventing discomfort. Furthermore, a temperature sensor monitors the air temperature in real time, ensuring safe use.
[0020] 4. In this invention, the adhesive base and the silicone disc are detachably connected. The adhesive base is a disposable consumable that is replaced periodically, while the silicone disc, ring cover, and humidity control mechanism, which integrate precision components, are reusable, effectively reducing the long-term use cost for patients. Attached Figure Description
[0021] Figure 1 This is a three-dimensional schematic diagram of the overall structure of the present invention; Figure 2 This is a front view schematic diagram of the silicone disk and the annular cover in this invention; Figure 3 This is a schematic diagram of the back structure of the silicone disk and the annular cover in this invention; Figure 4 This is a schematic diagram of the silicone disk structure in this invention; Figure 5 This is a schematic diagram of the adhesive chassis structure in this invention; Figure 6 This is a side cross-sectional view of the silicone disk in this invention. Figure 7 This is a schematic diagram of the hot air device in this invention.
[0022] In the diagram: 1. Adhesive base; 101. First through hole; 102. Clearance notch; 103. Positioning ring; 2. Silicone disc; 201. Second through hole; 202. Flexible ion sensing electrode; 3. Annular cover; 301. Spectral monitoring component; 3011. First housing; 3012. Multi-wavelength LED light source; 3013. Photodetector; 3014. Light-transmitting window; 302. Humidity sensor; 4. Humidity adjustment mechanism; 401. Hot air device; 4011. Second housing; 4012. Fan; 4013. Electric heating wire; 4014. Temperature sensor; 4015. Filter; 402. Air inlet duct; 403. Air outlet duct; 5. Control module; 6. Straps; 601. Connecting buckle. Detailed Implementation
[0023] 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. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0024] Please see Figures 1-7 The present invention provides an intelligent monitoring and leakage early warning nursing device for postoperative stoma in urology, comprising: an adhesive base 1, wherein adhesive layers are provided on both the upper and lower sides of the adhesive base 1, a first through hole 101 is provided in the middle of the adhesive base 1, and multiple clearance notches 102 are provided in a ring array around the first through hole 101 on the adhesive base 1.
[0025] The adhesive base 1 has adhesive layers on both its upper and lower sides. The lower adhesive layer is used to adhere to the skin around the patient's stoma, and the upper adhesive layer is used to connect to the silicone disc 2. A first through-hole 101 is formed in the center of the adhesive base 1 to accommodate the stoma. A plurality of clearance notches 102 are arranged in a ring array around the first through-hole 101, preferably 4-8 in number and evenly distributed, to provide a channel for the subsequent flexible ion-sensing electrode 202 to pass through.
[0026] The silicone disk 2 has a second through hole 201 in the middle. Multiple flexible ion sensing electrodes 202 are arranged in a ring array around the second through hole 201 on the silicone disk 2. The multiple flexible ion sensing electrodes 202 are arranged in a one-to-one correspondence with multiple clearance notches 102.
[0027] The silicone disc 2 is made of flexible silicone material, and its lower surface is fixedly connected to the upper surface of the adhesive base 1 by an adhesive layer. A second through-hole 201 corresponding to the first through-hole 101 is provided in the center of the silicone disc 2. Multiple flexible ion sensing electrodes 202 are arranged in a ring array around the second through-hole 201 on the lower surface of the silicone disc 2. The number and position of the flexible ion sensing electrodes 202 correspond one-to-one with the clearance notch 102. When worn, the flexible ion sensing electrodes 202 can pass through the clearance notch 102 and directly contact the skin.
[0028] The flexible ion sensing electrode 202 is fabricated on a flexible polyimide substrate using a screen printing process. The electrode material is Ag / AgCl conductive paste, and the electrode surface is covered with a solid hydrogel layer for stable contact with the skin and acquisition of ion signals. Its monitoring principle is based on the fact that the concentrations of chloride and sodium ions in urine (approximately 100-250 mmol / L) are significantly higher than those in sweat (approximately 20-60 mmol / L). When urine leaks between the base and the skin, the ion concentration detected by the electrode spikes instantly, exceeding a preset threshold. In contrast, the increase in ion concentration caused by sweat is smaller and slower. This allows for accurate differentiation between urine leakage and simple sweating, avoiding false alarms.
[0029] An annular cover 3 is mounted on the silicone disc 2, and a spectral monitoring component 301 and a humidity sensor 302 are respectively installed on the inner wall of the annular cover 3. A humidity regulating mechanism 4 is located on the outside of the annular cover 3 and is used to regulate the humidity inside the annular cover 3.
[0030] The humidity sensor 302 employs a miniature capacitive humidity sensor, such as the Sensirion SHT30 series, and is located on the upper side of the inner wall of the annular cover 3 to monitor the air humidity inside the annular cover 3 in real time. The humidity sensor 302 is covered with a waterproof and breathable membrane to prevent liquid urine from directly contacting the sensor while allowing water vapor to pass through. When the humidity sensor 302 detects that the humidity inside the annular cover 3 exceeds a threshold, it sends an alarm signal to a mobile app. The patient can then operate the humidity adjustment mechanism 4 to reduce the humidity inside the annular cover 3, preventing damage to the skin barrier function.
[0031] In addition, the end face of the annular cover 3 is provided with a snap-fit groove for snap-fit connection with the ostomy bag to realize urine collection. The ostomy bag is a common existing technology, so it will not be described in detail here.
[0032] The control module 5 is disposed on the surface of the silicone disk 2 and is electrically connected to the flexible ion sensing electrode 202, the spectral monitoring component 301, the humidity sensor 302 and the humidity adjustment mechanism 4, respectively.
[0033] The control module 5 has a built-in Bluetooth communication module, which can transmit the collected data to the mobile app in real time, and can send an alarm signal to the mobile app when the data is abnormal.
[0034] Preferably, the spectral monitoring component 301 includes two first housings 3011 symmetrically arranged on the annular cover 3, and the first housings 3011 communicate with the interior of the annular cover 3. A multi-wavelength LED light source 3012 is disposed inside one of the first housings 3011, and a photodetector 3013 is disposed inside the other first housing 3011. Each end of the two first housings 3011 has a light-transmitting window 3014 flush with the inner wall of the annular cover 3.
[0035] The multi-wavelength LED light source 3012 integrates LED chips with three wavelengths: 415nm, 540nm, and 660nm, corresponding to the absorption peak and reference wavelength of hemoglobin, respectively. The photodetector 3013 receives the light signal after it passes through the urine. The light-transmitting window 3014 is made of sapphire glass or high-transmittance medical-grade plastic, with a smooth surface, flush with the inner wall of the annular cover 3 to avoid creating unsanitary corners.
[0036] When a patient urinates, urine flows through a light-transmitting window 3014 on one side of a multi-wavelength LED light source 3012. The multi-wavelength LED light source 3012 emits beams of light at wavelengths of 415nm, 540nm, and 660nm sequentially. The light passes through the light-transmitting window 3014 and enters the interior of the annular cover 3, traversing the urine flow before striking the photodetector 3013 on the opposite side. When red blood cells are present in the urine, hemoglobin specifically absorbs light at wavelengths of 415nm and 540nm, causing an attenuation of the light intensity at these two wavelengths, while the 660nm reference wavelength is hardly absorbed. The photodetector 3013 converts the received light signals of each wavelength into electrical signals and transmits them to the control module 5. The control module 5 calculates the hemoglobin concentration in the urine by comparing the light intensity ratios of 415nm / 660nm and 540nm / 660nm, thereby determining whether hematuria is present. During the flow of urine, the multi-wavelength LED light source 3012 operates in a high-frequency pulse mode, which can complete dozens of measurements within a few seconds of urine flow, ensuring the accuracy and reliability of the test results.
[0037] Preferably, the humidity regulating mechanism 4 includes a hot air device 401 mounted on the surface of the silicone disc 2. The output end of the hot air device 401 is connected to an air inlet pipe 402, and the end of the air inlet pipe 402 is connected to an annular cover 3. An air outlet pipe 403 is connected to the surface of the annular cover 3, and valves are provided on both the air inlet pipe 402 and the air outlet pipe 403.
[0038] Before the patient activates the hot air device 401, the valves on the inlet pipe 402 and the outlet pipe 403 should be opened to ensure unobstructed airflow. Then, hot air enters the annular hood 3 through the inlet pipe 402, carrying moisture out through the outlet pipe 403, thereby achieving the purpose of dehumidification and maintaining the humidity balance inside the annular hood 3.
[0039] The valves on the air inlet pipe 402 and the air outlet pipe 403 are kept closed under normal circumstances to prevent urine leakage.
[0040] Preferably, the air inlet pipe 402 is tangentially connected to the annular cover 3.
[0041] Hot air enters the annular hood 3 tangentially through the air inlet duct 402 and rotates along the inner wall of the annular hood 3, forming a vortex. The vortex is evenly distributed inside the annular hood 3, completely sweeping over the skin surface around the stoma, effectively removing moisture before being discharged through the air outlet duct 403. This avoids direct airflow onto the stoma, preventing discomfort.
[0042] Preferably, the hot air device 401 includes a second housing 4011 mounted on the surface of the silicone disc 2. A fan 4012 and an electric heating wire 4013 are disposed inside the second housing 4011. The electric heating wire 4013 is disposed between the fan 4012 and the air inlet pipe 402. A filter screen 4015 is disposed at the air inlet end of the second housing 4011.
[0043] After the fan 4012 is started, the outside air enters the second housing 4011 after being filtered by the filter screen 4015. When it flows through the electric heating wire 4013, it is heated and formed into dry hot air, which is then sent into the annular cover 3 through the air inlet pipe 402.
[0044] The fan 4012 and the electric heating wire 4013 can be controlled independently. When the temperature is low, both can be turned on at the same time to generate hot air. When the weather is hot, the fan 4012 can be turned on alone to reduce the stuffiness at the stoma site for patients.
[0045] Filter 4015 can filter dust and impurities in the air, preventing pollutants from entering the annular cover 3 and causing secondary irritation or infection to the stoma.
[0046] Preferably, a temperature sensor 4014 is installed inside the air inlet duct 402, and the temperature sensor 4014 is electrically connected to the control module 5.
[0047] Temperature sensor 4014 monitors the airflow temperature inside air inlet duct 402 in real time and sends the data to control module 5. When the detected temperature exceeds a preset safety threshold (but does not exceed 38°C), control module 5 immediately reduces the power of electric heating wire 4013 or cuts off the heating circuit to avoid the risk of burns due to excessive temperature.
[0048] Preferably, a positioning ring 103 is provided on the first through hole 101, and the diameter of the positioning ring 103 is adapted to the inner diameter of the second through hole 201.
[0049] When installing the silicone pad 2, radial positioning is achieved using the positioning ring 103, and angular references are made to the positions of the spectral monitoring component 301 and the hot air device 401 to ensure the accuracy of the installation position. Furthermore, the size of the clearance notch 102 is slightly larger than the flexible ion sensing electrode 202, allowing for a certain margin of error, thus ensuring that the flexible ion sensing electrode 202 can pass through the clearance notch 102 and contact the skin.
[0050] Preferably, it also includes a strap 6, both ends of which are provided with Velcro assemblies that stick together, and both sides of the outer surface of the annular cover 3 are provided with connecting buckles 601.
[0051] After passing both ends of the strap 6 through the connecting buckles 601 on both sides of the ring cover 3, fold them back and secure them with Velcro. The patient can adjust the tightness of the strap 6 according to their waist circumference to ensure the device fits firmly to the body, further enhancing the stability of the device.
[0052] Preferably, the annular cover 3 is a funnel-shaped structure with a smaller diameter on the side closer to the silicone disk 2 and a larger diameter on the side farther away from the silicone disk 2.
[0053] The funnel-shaped structure provides drainage for urine, making it easier for urine to flow into the ostomy bag and preventing it from remaining inside the ring cover 3, which would increase humidity.
[0054] All standard parts used in this invention can be purchased from the market, and irregular parts can be customized according to the description and drawings. The specific connection methods of each part adopt conventional methods such as bolts, rivets, and welding that are mature in the prior art. The machinery, parts and equipment adopt conventional models in the prior art, and the circuit connection adopts conventional connection methods in the prior art, which will not be described in detail here. The contents not described in detail in this specification belong to the prior art known to those skilled in the art.
[0055] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.
Claims
1. A smart monitoring and leakage early warning nursing device for postoperative stoma in urology, characterized in that, include: An adhesive base (1) is provided with an adhesive layer on both the upper and lower sides. A first through hole (101) is provided in the middle of the adhesive base (1). Multiple clearance notches (102) are arranged in a ring array around the first through hole (101) on the adhesive base (1). A silicone disk (2) is provided with a second through hole (201) in the middle. A plurality of flexible ion sensing electrodes (202) are arranged in a ring array around the second through hole (201) on the silicone disk (2). The plurality of flexible ion sensing electrodes (202) are arranged in a one-to-one correspondence with the plurality of clearance notches (102). An annular cover (3) is disposed on the silicone disk (2), and the inner wall of the annular cover (3) is respectively provided with a spectral monitoring component (301) and a humidity sensor (302). Humidity regulating mechanism (4), the humidity regulating mechanism (4) is disposed on the outside of the annular cover (3) and is used to regulate the humidity inside the annular cover (3); The control module (5) is disposed on the surface of the silicone disk (2) and is electrically connected to the flexible ion sensing electrode (202), the spectral monitoring component (301), the humidity sensor (302) and the humidity adjustment mechanism (4), respectively.
2. The intelligent monitoring and leakage early warning nursing device for postoperative stoma in urology as described in claim 1, characterized in that: The spectral monitoring component (301) includes two first housings (3011) symmetrically arranged on the annular cover (3), and the first housings (3011) are in communication with the interior of the annular cover (3); A multi-wavelength LED light source (3012) is provided inside the first housing (3011) on one side, and a photodetector (3013) is provided inside the first housing (3011) on the other side. Both ends of the first housing (3011) are provided with light-transmitting windows (3014) that are flush with the inner wall of the annular cover (3).
3. The intelligent monitoring and leakage early warning nursing device for postoperative stoma in urology as described in claim 1, characterized in that: The humidity regulating mechanism (4) includes a hot air device (401) installed on the surface of the silicone disc (2), the output end of the hot air device (401) is connected to an air inlet pipe (402), and the end of the air inlet pipe (402) is connected to the annular cover (3). The surface of the annular cover (3) is connected to an air outlet pipe (403), and valves are provided on both the air inlet pipe (402) and the air outlet pipe (403).
4. The intelligent monitoring and leakage early warning nursing device for postoperative stoma in urology as described in claim 3, characterized in that: The air inlet pipe (402) is tangentially connected to the annular cover (3).
5. The intelligent monitoring and leakage early warning nursing device for postoperative stoma in urology according to claim 3, characterized in that: The hot air device (401) includes a second housing (4011) mounted on the surface of the silicone disc (2). Inside the second housing (4011) are a fan (4012) and an electric heating wire (4013). The electric heating wire (4013) is disposed between the fan (4012) and the air inlet pipe (402). A filter screen (4015) is provided at the air inlet end of the second housing (4011).
6. The intelligent monitoring and leakage early warning nursing device for postoperative stoma in urology as described in claim 5, characterized in that: A temperature sensor (4014) is installed inside the air inlet pipe (402), and the temperature sensor (4014) is electrically connected to the control module (5).
7. The intelligent monitoring and leakage early warning nursing device for postoperative stoma in urology according to claim 1, characterized in that: A positioning ring (103) is provided on the first through hole (101), and the diameter of the positioning ring (103) is adapted to the inner diameter of the second through hole (201).
8. The intelligent monitoring and leakage early warning nursing device for postoperative stoma in urology according to claim 1, characterized in that: It also includes a strap (6), both ends of which are provided with Velcro ties that stick together, and both sides of the outer surface of the ring cover (3) are provided with connecting buckles (601).
9. The intelligent monitoring and leakage early warning nursing device for postoperative stoma in urology according to claim 1, characterized in that: The annular cover (3) is a horn-shaped structure with a smaller diameter on the side closer to the silicone disk (2) and a larger diameter on the side farther away from the silicone disk (2).