Convex surface stoma base plate with pressure sensor
By integrating pressure sensors and detection modules onto the convex stoma chassis, the problem of patients having difficulty judging pressure values is solved, enabling pressure monitoring and feedback, and improving treatment effectiveness and user comfort.
Patent Information
- Application Number
- CN202423015534.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-05
- Publication Date
- 2026-01-06
- Estimated Expiration
- 2034-12-05
AI Technical Summary
When using existing convex stoma baseplates, patients often have difficulty accurately judging the pressure value during the wearing process, which can lead to pressure that is too low or too high, affecting the treatment effect or causing discomfort.
Design a convex stoma chassis with a pressure sensor. By setting a pressure sensor and a detection module on the chassis, the pressure status can be monitored and fed back in real time. The chassis includes a convex part, an extension part, an adhesive layer, a fastening part, and a detection module. The pressure data is transmitted in real time using a thin-film pressure sensor, a controller, and a communication module.
It enables precise monitoring of stoma pressure, helping patients adjust pressure values, reduce discomfort, improve treatment outcomes, enhance tissue stability and blood distribution, and reduce the risk of leakage.
Smart Images
Figure CN223759965U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of ostomy device technology, specifically to a convex ostomy chassis with a pressure sensor. Background Technology
[0002] An ostomy is typically used for rectal or bladder diseases. To save the patient's life, doctors surgically remove the affected area; for example, in cases of rectal cancer, the rectum and anal canal are removed, and in cases of bladder cancer, the bladder is removed. An incision is then made on the left or right side of the patient's abdomen. Because urine and feces are involuntarily expelled through the stoma, a stoma baseplate and ostomy bag are attached to the stoma to collect waste. The primary principle of stoma management is ensuring a tight seal between the stoma baseplate and the skin to prevent leakage and irritation of the surrounding skin by waste.
[0003] Patients' stomas present various conditions, including stoma height below the skin, stoma level with the skin, stoma deviated from the skin, stoma above the skin but with surrounding tissue retraction, and stoma contraction and peristalsis. In these cases, a standard flat stoma baseplate may not fit tightly when applied to the stoma. Therefore, a convex stoma baseplate was developed. This convex baseplate, used in conjunction with a waist belt, applies pressure to the skin around the stoma, ensuring the stoma outlet is above the skin surface. This facilitates better collection of excrement and reduces leakage and skin damage. The convex stoma baseplate also provides multiple benefits, including reducing edema, inhibiting scar hyperplasia, enhancing tissue stability, promoting blood redistribution, and reducing local congestion.
[0004] The inventors discovered in clinical practice that during treatment using a convex stoma baseplate, insufficient pressure on the stoma leads to poor treatment outcomes, while excessive pressure can cause patient discomfort and other potential risks. While the convex stoma baseplate is typically worn by the patient themselves or with the assistance of medical staff, it was found that only highly experienced medical personnel or patients can accurately control the pressure within the appropriate range. However, most patients cannot accurately judge the pressure, resulting in either too low or too high pressure.
[0005] Therefore, there is an urgent need for a device that can help users understand the pressure state of the convex stoma base plate on the stoma. Utility Model Content
[0006] The present invention aims to provide a convex stoma base plate with a pressure sensor to solve the problem that the existing convex stoma base plates cannot help users understand the pressure state of the convex stoma base plate on the stoma.
[0007] To achieve the above objectives, the present invention adopts the following technical solution: it includes a convex base, which includes a protrusion and an annular extension located at the top of the protrusion. The protrusion is provided with a through hole for the stoma to pass through. The lower surface of the extension is provided with an adhesive layer for fixing to the skin, and the upper surface of the extension is provided with a fastening part for fastening to the ostomy bag. It also includes a detection module, which includes a pressure sensor and a power supply module electrically connected to the pressure sensor. The detection end of the pressure sensor is located at one or any two or three locations on the bottom wall, side wall, and bottom surface of the extension of the convex base.
[0008] Beneficial effects:
[0009] 1. Setting the detection point on the bottom wall can detect the downward pressure of the convex base on the patient's skin, which is the main reference pressure value; due to the slope of the convex base, setting the detection point on the side wall can detect the tension exerted by the side wall on the skin around the stoma; setting the detection point on the bottom surface of the outer extension can detect the force exerted by the stoma belt on the patient's skin when used in conjunction with the stoma belt.
[0010] 2. When the raised portion applies pressure to the patient's skin, the pressure sensor can measure the pressure value. If the convex base plate applies appropriate pressure to the patient's stoma, it can reduce edema, inhibit scar hyperplasia, enhance tissue stability, promote blood redistribution, and reduce local congestion, among other benefits. Insufficient pressure will result in poor treatment efficacy; excessive pressure will cause patient discomfort. Therefore, the pressure sensor helps users understand the pressure state of the convex stoma base plate on the stoma, facilitating subsequent adjustments to the pressure applied by the convex base plate.
[0011] Preferably, as an improvement, the pressure sensor is a thin-film pressure sensor.
[0012] Beneficial effects: Compared with traditional pressure sensors, thin-film pressure sensors have the advantages of high sensitivity, high accuracy, fast response and bend resistance. Moreover, they are thin and light, and can fit well into the outer wall of the convex chassis.
[0013] Preferably, as an improvement, there are multiple pressure sensors; the detection ends of the pressure sensors are staggered, or the detection ends of the pressure sensors are located in the same plane; when the detection ends of the pressure sensors are located in the same plane, the detection ends of each pressure sensor are connected by a connecting strip.
[0014] Beneficial effects:
[0015] 1. The offset setting of the pressure sensor's detection end makes the force applied to the stoma by the convex base more uniform, because the detection end has less impact on the process of the convex base applying pressure to the stoma and surrounding skin.
[0016] 2. The detection ends of the pressure sensors are located on the same plane and are connected by a connecting strap, which makes installation more convenient. After fixing the detection end of one pressure sensor, the remaining detection ends can be fixed to the outer wall of the convex chassis along the connecting strap.
[0017] Preferably, as an improvement, the detection module further includes a controller and a communication module; the power supply module is electrically connected to the pressure sensor, the controller, and the communication module for power supply; the controller is signal connected to the pressure sensor and the communication module.
[0018] Beneficial effects: When the protrusion applies pressure to the patient's skin, the pressure sensor measures the pressure value and transmits the data to the controller. The controller then sends the data to the communication module, which can transmit it to a host device, such as a mobile phone or monitor, in real time. The controller and communication module are designed to allow the patient to adjust the pressure of the convex base plate on the stoma according to the data displayed on the host device.
[0019] Preferably, as an improvement, the housing of the detection module is fixed to the upper surface of the extension portion.
[0020] Beneficial effects: The controller, communication module, and power supply are integrated on the circuit board, which is covered by a sealed shell that is fixed to the upper surface of the extension. This arrangement is closer to the pressure sensor detection end, saving wiring; at the same time, it does not affect the installation of the ostomy bag.
[0021] Preferably, as an improvement, the fastening part is provided with connecting ears on both sides for connecting with the stoma belt, and the outer shell of the detection module is fixed on the stoma belt.
[0022] Beneficial effects: By placing an integrated controller, communication module, and power supply in the stoma belt, the structure of the convex chassis can be simplified, and the housing of the detection module will not cause discomfort or pain to the patient's skin when the stoma belt is worn.
[0023] Preferably, as an improvement, the bottom wall of the raised portion of the convex chassis is provided with a cuttable area for adjusting the size of the through hole.
[0024] Beneficial effect: It makes it easier for patients to cut a suitable through-hole according to the size of the stoma.
[0025] Preferably, as an improvement, the bottom wall of the raised part of the convex chassis is made of a malleable hydrocolloid material.
[0026] Beneficial effects: Patients can directly knead the bottom wall of the convex base plate to the appropriate size and shape to fit the stoma without the need for other auxiliary tools, making it more convenient to use and providing a tighter fit.
[0027] Preferably, as an improvement, the outer wall of the convex chassis is provided with a mounting groove for mounting the detection end of the pressure sensor.
[0028] Beneficial effects: The installation slot makes it easy to quickly and accurately locate the installation point during the production process, thus speeding up the installation efficiency; and it can prevent the detection end from being installed in an area that will be cut / pinched, thus affecting the accuracy of the pressure value measured by the detection end.
[0029] Preferably, as an improvement, a waterproof membrane is fitted and sealed onto the mounting groove.
[0030] Beneficial effects: When producing convex stoma base plates, sealing the mounting groove with a waterproof membrane can prevent the patient's sweat, stoma exudate, etc. from flowing to the detection end during use, causing adverse effects such as short circuits. Attached Figure Description
[0031] Figure 1 This is a left-axis side view of the thin-film pressure sensor of Embodiment 1 of the present invention, in which the detection end is located in the molding area of the malleable convex chassis.
[0032] Figure 2 for Figure 1 An enlarged schematic diagram of point A.
[0033] Figure 3 This is a right-axis view of the molding area of a thin-film pressure sensor according to Embodiment 1 of the present invention, where the detection end is located on a malleable convex chassis and the outer shell is sealed with a waterproof membrane.
[0034] Figure 4 This is a logic block diagram of the detection module in Embodiment 2 of this utility model.
[0035] Figure 5 This is a schematic diagram of a waterproof membrane covering the surface of the mounting groove in Embodiment 3 of this utility model. Figure 2 (Replacement image).
[0036] Figure 6 This is a right-axis side view of Embodiment 4 of the present invention when a waterproof cover is used to close the outer shell.
[0037] Figure 7 This is a cross-sectional view of the groove in Embodiment 4 of this utility model when a waterproof cover is used to cover the outer shell.
[0038] Figure 8 The left-axis side view shows that the pressure sensor of Embodiment 5 of this utility model has three detection ends arranged on the same plane.
[0039] Figure 9 The left-axis side view shows that the pressure sensor of Embodiment 5 of this utility model has three detection ends, which are staggered.
[0040] Figure 10The left-axis side view shows that the pressure sensor of Embodiment Six of this utility model has three detection ends, which are arranged on the same plane and connected by a connecting strap.
[0041] Figure 11 This is a right-axis side view of the detection module housing fixed to the stoma belt in Embodiment 5 of this utility model.
[0042] Figure 12 This is a left-axis side view of Embodiment Six of the present invention, which uses a cuttable convex chassis. Detailed Implementation
[0043] The following detailed description illustrates the specific implementation method:
[0044] The reference numerals in the accompanying drawings include: 1. protrusion; 2. extension; 3. fastening part; 4. pressure sensor; 41. detection end; 5. outer shell; 6. groove; 7. waterproof cover; 8. sealing ring; 9. connecting ear; 10. stoma belt; 11. connecting belt.
[0045] The basic implementation examples are as follows: Figures 1-11 As shown:
[0046] Example 1
[0047] A convex stoma base plate with a pressure sensor, as shown in Figure 1- Figure 3 As shown, it includes a convex chassis and a detection module. The convex chassis in this embodiment is a malleable convex chassis. Taking models 404592, 404593, and 404594 as examples, the dimensions are 11.4cm×11.4cm or 12.7cm×12.7cm. The convex base includes a protrusion 1 and an extension 2 located at the top of the protrusion 1. The protrusion 1 extends downward at a certain depth with a slight inward inclination and extends straight inward at the end to form an annular bottom wall. A circular through hole for the stoma to pass through is provided in the center of the bottom wall. In this embodiment, the bottom wall is made of a plastic hydrocolloid material, hence the bottom wall in this embodiment is called the shaping area. The lower surface of the extension 2 is provided with an adhesive layer for fixing to the skin (the surface of this layer is bonded with release paper to isolate dust). The upper surface of the extension 2 is provided with an annular fastening part 3 for fastening with the ostomy bag. Connecting ears 9 are provided on both sides of the fastening part 3 for connecting with the stoma belt 10. The center of the fastening part 3 is coaxial with the center of the through hole in the shaping area of the protrusion 1, and the fastening part 3 is elastic to ensure that the retaining ring rebounds without deformation after bending, which can extend the service life of the convex stoma base.
[0048] The detection module includes a pressure sensor 4 and a power module electrically connected to the pressure sensor 4. In this embodiment, the power module uses a CR927, CR1025, or other type of miniature button battery. The power module is sealed with a housing 5, which is adhered and fixed to the upper surface of the extension portion 2. The housing 5 can be sealed with a waterproof membrane, specifically in two ways: one is to circumferentially seal the housing 5, and the other is to seal the entire upper surface of the extension portion 2. Figure 3 As shown, the housing 5 is enclosed between the waterproof membrane and the extension portion 2. The wires of the integrated module inside the housing 5 pass through the extension portion 2 of the convex chassis and are electrically connected to the pressure sensor 4. In this embodiment, the pressure sensor 4 is a DF9-40 series thin-film pressure sensor 4, such as... Figure 1 As shown, the detection end 41 of the pressure sensor 4 is located on the bottom wall of the convex chassis near the outer side. By placing the detection end 41 on the bottom wall, the downward pressure of the convex chassis on the patient's skin can be detected, providing the main reference pressure value.
[0049] Example 2
[0050] The difference between this embodiment and Embodiment 1 is that the detection module further includes a controller and a communication module; the power supply module is electrically connected to the pressure sensor, the controller, and the communication module, and the power supply module is used to supply power to the pressure sensor, the controller, and the communication module; the controller is signal-connected to the pressure sensor and the communication module.
[0051] The housing 5 integrates a power module (in this embodiment, a CR927, CR1025, or other type of miniature button battery), a controller (in this embodiment, an nRF52805CAAA, STM32 series, or other microcontrollers), and a communication module (specifically, a wireless communication module, including one or more of WiFi, Bluetooth, ZigBee, and LoRa modules; in this embodiment, a WiFi module is used). The power module is electrically connected to the pressure sensor 4, the controller, and the communication module to provide power. The controller is signal-connected to the pressure sensor 4 and the communication module. The controller reads the pressure value data from the detection end 41 of the pressure sensor 4 and sends it to the host device via the communication module. The logic block diagram of the detection module is shown below. Figure 4 As shown, dashed lines represent signal transmission paths, and solid lines represent electrical transmission paths.
[0052] It should be noted that the thin-film pressure sensor 4 in this invention is not limited to convex base plates; it can also be attached to flat base plates, and it can also measure the effective pressure of the flat base plate on the stoma. In other embodiments besides this one, a planar stoma base plate with a pressure sensor is disclosed, suitable for patients with flat skin around the stoma. It includes a base plate body and an outer wing disposed around the circumference of the base plate body, the bottom surface of the outer wing being an adhesive layer with release paper; the detection end 41 of the pressure sensor 4 is disposed on the side of the base plate body that contacts the skin.
[0053] Operating procedures:
[0054] This utility model relates to a convex stoma base plate used in conjunction with a stoma belt 10. Before wearing the convex base plate, first knead the shaping area of the convex base plate to the appropriate size for the stoma. Then, thoroughly clean the stoma and surrounding skin with a cleansing wipe. Next, evenly spray stoma skin care powder onto the skin around the stoma, spread it evenly, and remove any excess powder. Finally, spray a stoma skin protectant 10cm away from the skin, evenly covering the skin around the stoma, and wait for the skin to dry. When wearing the device, first wear the stoma leak-proof plastic band, adjust the plastic band to the shape of the stoma, and gently press it around the stoma. Then, remove the release paper from the surface of the adhesive layer of the convex base plate, align the convex base plate with the stoma, and stick it to the skin. Press the entire stoma perimeter with your fingers to ensure a firm adhesion. Then, fasten the stoma bag to the annular fastening part 3. Finally, connect the stoma belt 10 to the connecting ear 9 of the fastening part 3. After the patient puts on the stoma belt 10, the convex base plate applies pressure to the patient's stoma. The detection end 41, located in the shaping area of the convex base plate, can help detect the positive downward force applied by the convex base plate to the patient's stoma, and can help the user understand the pressure status.
[0055] Example 3
[0056] The difference between this embodiment and Embodiment 1 is that, Figure 5 As shown, the specific installation method of the pressure sensor 4 is as follows: a mounting groove for installing the pressure sensor 4 is set in the molding area. It should be noted that the detection end 41 is pasted and fixed in the mounting groove, but the surface of the detection end 41 that contacts the skin protrudes from the groove 6 or is flush with the outer circumferential wall of the convex base to ensure that the pressure sensor 4 can accurately measure the pressure. After the pressure sensor 4 is installed in the mounting groove, a waterproof membrane is covered on the surface of the mounting groove to seal it.
[0057] Example 4
[0058] The difference between this embodiment and Embodiment 1 lies in the sealing and waterproofing method of the outer casing 5. This embodiment uses a waterproof cover 7 for sealing, such as... Figure 6 , Figure 7As shown, a mounting base is provided on the upper surface of the extension 2. The mounting base has a groove 6 for mounting the outer casing 5. The groove 6 is three-step shaped. The outer casing 5 is positioned at the first step. A waterproof cover 7 is detachably mounted on the groove 6. The waterproof cover 7 includes a plug and an edge extending circumferentially along the plug. The plug can be pressed against the second step. A sealing ring 8 is provided between the plug and the second step. The sealing ring 8 is configured as two layers, with the inner diameter of the lower sealing ring 8 being larger than that of the upper sealing ring 8. The edge of the waterproof cover 7 can be closed onto the third step. The design of the waterproof cover 7, compared to directly covering the outer casing 5, allows for the removal and installation of the button battery. When the convex chassis is needed, the button battery can be installed into the outer casing 5 and then into the groove 6. After installation, the waterproof cover 7 can be closed onto the groove 6.
[0059] Example 5
[0060] The difference between this embodiment and Embodiment 1 is that the detection end 41 of the thin-film pressure sensor in this embodiment is provided with three parts, which are respectively located in the convex base molding area, the side wall, and the outer extension 2. Figure 8 As shown, the three detection ends 41 are located in the same vertical plane. They can respectively assist in detecting the downward pressure exerted by the convex base on the patient's skin, the outward tension exerted by the sidewall of the convex base on the skin around the stoma, and the pressure exerted by the extension 2 on the patient's skin, providing multi-angle assistance to the user in understanding the pressure status. In other embodiments besides this one, such as... Figure 9 As shown, the three detection terminals 41 can also be set in a staggered manner.
[0061] Example 6
[0062] The difference between this embodiment and embodiment five is that the three detection ends 41 are located on the same plane, and the three detection ends 41 are connected by the connecting strip 11, as shown below. Figure 10 As shown. It can also simultaneously detect the downward pressure exerted by the convex base on the patient's skin, the outward tension exerted by the sidewall of the convex base on the skin around the stoma, and the pressure exerted by the extension 2 on the patient's skin. When manufacturing this convex base, only the detection end 41 of one pressure sensor 4 needs to be fixed, and the remaining detection ends 41 are fixed to the outer wall of the convex base along the connecting strap 11, making installation more convenient and quick.
[0063] Example 7
[0064] The difference between this embodiment and Embodiment 1 is that the outer shell 5 of the detection module is fixed to the stoma belt 10, such as... Figure 11As shown. The wires of the integrated module inside the housing 5 pass through the stoma belt 10 and the outer extension 2 of the convex base, and are electrically connected to the pressure sensor 4. The housing 5 and the stoma belt 10 can be fixed by adhesive or fastening. The fastening method is as follows: a base with a slot is glued and fixed to the stoma belt 10. The slot is set along the width direction of the base, with an open top and a closed bottom; the housing 5 of the integrated module is provided with a protrusion that can be inserted into the slot; the housing 5 of the integrated module is fixed by the cooperation of the protrusion and the slot, and this method is convenient for disassembly.
[0065] Example 8
[0066] The difference between this embodiment and any of the preceding embodiments is that: Figure 12 As shown, a cuttable convex base is used. The bottom wall of the protruding part 1 of the convex base is provided with a cuttable area for adjusting the size of the through hole. Before use, it needs to be cut to the appropriate size of the stoma with scissors. The rest of the structure and operation process are the same as those in the aforementioned embodiment.
[0067] The above descriptions are merely embodiments of this utility model. Commonly known technical solutions and / or characteristics are not described in detail here. It should be noted that those skilled in the art can make various modifications and improvements without departing from the technical solution of this utility model. These modifications and improvements should also be considered within the scope of protection of this utility model, and will not affect the effectiveness of the implementation of this utility model or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.
Claims
1. A convex stoma base plate with pressure sensor, comprising a convex base plate, the convex base plate comprising a convex part (1) and an annular extension part (2) located on top of the convex part (1), a through hole for stoma penetration being arranged on the convex part (1); a lower surface of the extension part (2) is provided with an adhesive layer for fixing with the skin, and an upper surface of the extension part (2) is provided with a fastening part (3) for fastening with a stoma bag; characterized in that, The detection module further comprises a controller and a communication module; the power module is electrically connected with the pressure sensor (4), the controller and the communication module, and is used for power supply; the controller is signal connected with the pressure sensor (4) and the communication module.
2. The convex stoma base with pressure sensor of claim 1, wherein: The pressure sensor (4) is a thin film pressure sensor (4).
3. The convex ostomy base plate with pressure sensor according to claim 2, characterized in that: The pressure sensor (4) is a plurality of pressure sensors (4); the detection ends (41) of the pressure sensors (4) are arranged in a staggered manner, or the detection ends (41) of the pressure sensors (4) are located in the same plane; when the detection ends (41) of the pressure sensors (4) are located in the same plane, the detection ends (41) of each pressure sensor (4) are connected through a connecting belt (11).
4. The convex stoma base with a pressure sensor according to any one of claims 1-3, characterized in that: The detection module further comprises a controller and a communication module; the power module is electrically connected with the pressure sensor (4), the controller and the communication module, and is used for power supply; the controller is signal connected with the pressure sensor (4) and the communication module.
5. The convex stoma base with pressure sensor of claim 4, wherein: The shell (5) of the detection module is fixed to the upper surface of the extension part (2).
6. The convex stoma base with pressure sensor of claim 4, wherein: The two sides of the buckling part (3) are provided with connecting ears (9) for connecting with an ostomy waistband (10), and the shell (5) of the detection module is fixed to the ostomy waistband (10).
7. The pressure sensor-equipped convex stoma base plate according to claim 1, characterized by: The bottom wall of the convex part (1) of the convex base is provided with a cuttable area for adjusting the size of the through hole.
8. The pressure sensor-equipped convex stoma base plate according to claim 1, characterized by: The bottom wall of the convex part (1) of the convex base is made of a plastic hydrogel material.
9. The convex ostomy base plate with pressure sensor according to claim 1 or 2, characterized in that: The outer wall of the convex base is provided with a mounting groove for mounting the detection end (41) of the pressure sensor (4).
10. The convex stoma base with pressure sensor of claim 9, wherein: A waterproof film is attached and covered on the mounting groove for sealing.