In-vitro fixing device for dialysis tube for kidney diseases
By combining an adaptive clamping mechanism and an intelligent monitoring module, the problems of unstable fixation and insufficient comfort of existing dialysis catheter external fixation devices have been solved, achieving stable fixation and comfortable wearing of dialysis catheters, thereby improving the safety of dialysis treatment and patient satisfaction.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- SHANGHAI SIXTH PEOPLES HOSPITAL
- Filing Date
- 2026-03-02
- Publication Date
- 2026-04-14
AI Technical Summary
Existing external fixation devices for dialysis catheters are inadequate in terms of fixation stability, human adaptability, and ease of operation. They cannot adapt to different sizes of dialysis catheters and the patient's body curves, resulting in a decrease in the safety and comfort of dialysis treatment.
An external fixation device for dialysis tubing was designed, comprising an adaptive clamping mechanism, a buffer assembly, and an intelligent monitoring module. The adaptive clamping mechanism adapts to dialysis tubing of different diameters, the buffer assembly absorbs external forces, and the intelligent monitoring module detects abnormalities in real time and provides early warnings, thereby achieving stable fixation and comfortable wearing of the dialysis tubing.
It improves the stability and comfort of dialysis catheter fixation, reduces the risk of infection, enhances the safety and continuity of dialysis treatment, reduces the workload of medical staff, and increases patient satisfaction.
Smart Images
Figure CN121846476A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, specifically to an external fixation device for dialysis catheters used in kidney disease. Background Technology
[0002] Hemodialysis is a core treatment for end-stage renal disease patients to maintain life. As a crucial pathway for blood-dialysis fluid exchange, the stability of the external fixation of the dialysis catheter directly affects the safety and effectiveness of dialysis treatment. Currently, commonly used external fixation devices for dialysis catheters are mainly divided into two categories: adhesive tape type and snap-on type. However, both types of devices have many shortcomings in practical applications that urgently need to be addressed.
[0003] For tape-attached devices, their fixation relies entirely on the adhesive strength of the tape. However, kidney patients often experience abnormal skin metabolism due to dialysis treatment, leading to increased sweating and sebum imbalances. This causes the tape's adhesiveness to weaken rapidly, resulting in catheter displacement. Furthermore, adhesive residue is difficult to clean, can damage the patient's skin during replacement, and long-term use can induce contact dermatitis. While snap-on devices avoid the adhesive problem, their fixed clamping spacing, limited by their structural design, cannot accommodate different sizes of dialysis catheters used clinically. The poor fit between the snap and the catheter means that even slight movements like patient turning can generate pulling forces, causing catheter displacement or even bending, leading to bleeding at the puncture site, dialysate leakage, and significantly increasing the risk of infection.
[0004] Furthermore, the mounting bases of existing devices are mostly made of homogeneous, rigid plastic, with uniform sizes that cannot conform to the different body curves of obese and thin patients, such as thigh circumference. Prolonged wear can easily create localized pressure stress, leading to skin redness and ischemia, and in severe cases, pressure sores. Regarding breathability, traditional devices often have a sealed structure in contact with the skin, preventing the normal dissipation of heat and sweat. Especially in summer, this can easily breed bacteria and cause eczema, further exacerbating the burden on the patient's skin.
[0005] Therefore, the development of an external fixation device for dialysis catheters that combines stability, human adaptability, and ease of operation has become an urgent need in the field of clinical dialysis treatment. Summary of the Invention
[0006] To address the aforementioned issues, this invention provides an external fixation device for dialysis catheters used in kidney disease. This device enables adaptive and stable fixation of the dialysis catheter, while also adapting to different patient body curves to improve wearing comfort. Furthermore, it can accommodate dialysis catheters of different diameters, ensuring the safety and continuity of dialysis treatment.
[0007] To achieve the above objectives, the technical solution of the present invention is as follows: an external fixation device for dialysis tubing in kidney disease, comprising a main band for conforming to the human body and an adjustment assembly for fixing the dialysis tubing, wherein an arc-shaped shaping component is embedded inside the main band, and both ends of the main band are provided with detachably connected fixing parts; the adjustment assembly includes an adjustment seat that slides with the main band, and the adjustment seat is provided with an adaptive clamping mechanism, which is used to synchronously adjust the clamping distance along the radial direction of the dialysis tubing to conform and fix dialysis tubing of different diameters; a buffer assembly is also provided between the main band and the adjustment seat, which is used to absorb the external force when the dialysis tubing is pulled.
[0008] Furthermore, the adaptive clamping mechanism includes two symmetrically arranged arc-shaped clamping blocks, a guide rod, and an adjusting component. The guide rod horizontally penetrates the side wall of the adjusting seat, and both ends of the guide rod are provided with threads in opposite directions. The arc-shaped clamping blocks are fitted onto the guide rod, and one end of the guide rod is fixedly engaged with the adjusting component, which is a wing bolt. The end of the adjusting component extends to the outside of the adjusting seat. When the wing bolt is rotated, the two arc-shaped clamping blocks can be driven to move synchronously in opposite directions along the guide rod. The inner side wall of the arc-shaped clamping blocks is fixedly connected with an anti-slip silicone pad, and the surface of the silicone pad is provided with a wavy anti-slip texture.
[0009] Furthermore, the buffer assembly includes a buffer sleeve, a compression spring, and a pressure sensor. One end of the buffer sleeve is fixed to the bottom of the adjustment seat, and the other end of the buffer sleeve is connected to the main belt body through the compression spring, forming a floating structure that can extend and retract axially.
[0010] The pressure sensor is embedded inside the buffer sleeve and is used to monitor the pressure value generated by the deformation of the compression spring in real time. The main belt is fixed by a Velcro fastener, and the Velcro fastener has length scale lines on its contact surface. The length scale lines are used to precisely adjust the tightness of the main belt.
[0011] Furthermore, the main belt has a three-layer composite structure, consisting of a breathable mesh layer, a moisture-wicking cotton layer, and a skin-friendly antibacterial fabric layer from the outside to the inside. Honeycomb-shaped breathable channels are provided between the three composite structures. The arc-shaped shaping component is embedded between the moisture-wicking cotton layer and the skin-friendly antibacterial fabric layer along the length of the main belt. The arc-shaped shaping component is used to maintain the curvature that matches the curve of the human body after shaping.
[0012] Furthermore, the adjustment seat has a hollow rectangular structure, and the bottom end of the adjustment seat that contacts the skin has several hollow areas, in which activated carbon moisture-absorbing sheets can be detachably connected; the side wall of the adjustment seat has ventilation holes that communicate with the honeycomb-shaped ventilation channels, and the ventilation holes are used to form an air convection channel between the main belt and the adjustment seat.
[0013] Furthermore, it also includes a puncture point monitoring module, which includes an annular silicone sealing gasket and a humidity sensor. The annular silicone sealing gasket is arranged around the dialysis tube, with its bottom fitting against the skin and its top fixed to the bottom of the adjustment seat. The humidity sensor is embedded in the inner wall of the annular silicone sealing gasket and is used to detect humidity changes in the puncture point area.
[0014] Furthermore, it also includes a tube condition monitoring module, which includes a pressure strain gauge. The pressure strain gauge is embedded inside the anti-slip silicone pad on the inner side of the arc-shaped clamping block, and the sensing surface of the pressure strain gauge is in contact with the outer wall of the dialysis tube. When the dialysis tube is bent, causing the tube body to deform, the pressure strain gauge can convert the deformation into an electrical signal.
[0015] Furthermore, it also includes an early warning module, which includes a controller, an indicator light, and a buzzer. The controller is electrically connected to the pressure sensor, humidity sensor, pressure strain gauge, indicator light, and buzzer, respectively. When any of the pressure sensor, humidity sensor, or pressure strain gauge detects an abnormal signal, the controller triggers the indicator light and buzzer.
[0016] Furthermore, a positioning bolt is provided at the sliding connection between the adjusting seat and the main belt body, and a positioning hole is provided on the surface of the main belt body along the length direction. The positioning bolt passes through the adjusting seat and cooperates with the positioning hole. The positioning bolt and the positioning hole are used to fix the adjusting seat on the main belt body.
[0017] Furthermore, the controller has a built-in Bluetooth transmission module, which is used to push abnormal signals to medical terminals and patient mobile devices in real time.
[0018] The above approach has the following beneficial effects:
[0019] 1. This solution improves the stability of dialysis tubing by linking the adaptive clamping mechanism with the positioning and fixing structure. Compared with traditional technologies that rely on adhesive tape or single buckles, the guide rod's reverse threads at both ends drive the arc-shaped clamping blocks to move synchronously. Combined with the wavy texture of the anti-slip silicone pad, it can accommodate dialysis tubing of different diameters, improving the clamping fit. The adjusting seat is rigidly fixed to the positioning hole of the main tape body by the positioning bolt, and combined with the buffer component to absorb the pulling force, it solves the problem of tubing displacement caused by slight patient movement in traditional devices. The incidence of puncture site bleeding and dialysate leakage is reduced, and the source of infection risk is blocked structurally.
[0020] 2. This solution significantly improves patient fit and wearing comfort through the synergistic optimization of the main strap composite structure and the breathable design of the adjustment seat. Compared with the rigid material and single-size fixed base in traditional technology, the malleable arc-shaped shaping component embedded in the main strap can adjust the curvature according to the curve of the human body, perfectly fitting the different parts such as the thigh circumference of obese and thin patients. The honeycomb breathable channel of the three-layer composite structure and the hollow area and ventilation holes of the adjustment seat form air convection. Combined with the water absorption effect of the activated carbon moisture-absorbing sheet, the heat dissipation efficiency of the skin contact area is improved and the amount of sweat residue is reduced. This solves the problems of skin redness, pressure sores and eczema allergies caused by long-term wear of traditional devices, and extends the patient's wearing tolerance time.
[0021] 3. This solution significantly improves operational convenience and reduces reliance on medical staff through the integration of modular structural design and intelligent monitoring system. Compared with the complex operation of traditional technology, which requires multiple people to cooperate for installation and disassembly of multiple parts for replacement, the length scale line of the main strap's Velcro buckle allows for precise adjustment and fixation by a single person. The manual operation of the butterfly bolts eliminates the need for professional tools to clamp the dialysis tube. The automatic monitoring and Bluetooth signal push function of the early warning module replaces the abnormality detection mode of traditional technology that relies on regular inspections by medical staff. When there is excessive traction, leakage at the puncture point, or tube bending, the abnormal signal can be synchronized to the medical staff terminal and the patient's device in real time, shortening the response time for medical staff. At the same time, the patient can receive early warning prompts through the APP. Combined with the convenient operation of the device reset button, it realizes the transformation from passive dependence to active management, reducing the workload of medical staff.
[0022] 4. This solution constructs a comprehensive safety assurance system for the entire dialysis process through a closed-loop design of multi-dimensional monitoring and early warning. Compared with devices in traditional technologies that only have basic fixation functions, the puncture point humidity sensor, the tube pressure strain gauge, and the buffer pressure sensor form a triple monitoring network, which can detect early abnormalities such as trace bleeding and tube bending. The combination of indicator lights and buzzers driven by the controller for local early warning and Bluetooth remote push solves the problem of delayed abnormality detection in traditional technologies, avoids risks such as delayed treatment due to decreased dialysis flow and aggravated anemia due to puncture point bleeding, provides technical support for the safety of dialysis treatment, and improves patient treatment satisfaction.
[0023] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description
[0024] Figure 1 This is an isometric view of an embodiment of the external fixation device for dialysis catheters for kidney disease of the present invention;
[0025] Figure 2 This is a front view of an embodiment of the external fixation device for dialysis catheters for kidney disease of the present invention;
[0026] Figure 3 for Figure 2 A cross-sectional view along the AA direction.
[0027] The reference numerals in the accompanying drawings of the instruction manual include: 1. Main strap body; 2. Adjustment seat; 3. Arc-shaped clamping block; 4. Guide rod; 5. Adjustment component; 6. Velcro fastener; 7. Positioning bolt. Detailed Implementation
[0028] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. 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.
[0029] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.
[0030] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.
[0031] The following detailed description illustrates the specific implementation method:
[0032] Example 1:
[0033] As attached Figures 1 to 3As shown: An external fixation device for dialysis catheters in kidney disease includes a main strap 1 for conforming to the human body and an adjustment component for fixing the dialysis catheter. An arc-shaped shaping component is embedded inside the main strap 1. The main strap 1 has a three-layer composite structure, consisting of a breathable mesh layer, a moisture-wicking cotton layer, and a skin-friendly antibacterial fabric layer from the outside to the inside. A honeycomb-shaped breathable channel is provided between the three layers. The arc-shaped shaping component is embedded between the moisture-wicking cotton layer and the skin-friendly antibacterial fabric layer along the length of the main strap 1. The arc-shaped shaping component is used to maintain the curvature that conforms to the curve of the human body after shaping.
[0034] The main belt 1 has detachable fixing parts at both ends; the adjustment assembly includes an adjustment seat 2 that slides with the main belt 1. The adjustment seat 2 has an adaptive clamping mechanism inside. The adaptive clamping mechanism is used to synchronously adjust the clamping distance along the radial direction of the dialysis tube to fit and fix dialysis tubes of different diameters; the adaptive clamping mechanism includes two symmetrically arranged arc-shaped clamping blocks 3, a guide rod 4 and an adjustment component 5. The guide rod 4 horizontally penetrates the side wall of the adjustment seat 2. The two ends of the guide rod 4 are respectively provided with threads in opposite directions. The arc-shaped clamping blocks 3 are fitted onto the guide rod 4. One end of the guide rod 4 is fixedly engaged with the adjustment component 5. The adjustment component 5 is a butterfly bolt. The end of the adjustment component 5 extends to the outside of the adjustment seat 2. When the butterfly bolt is rotated, it can drive the two arc-shaped clamping blocks 3 to move synchronously in opposite directions along the guide rod 4; the inner side wall of the arc-shaped clamping block 3 is fixedly connected with an anti-slip silicone pad. The surface of the silicone pad is provided with a wavy anti-slip texture.
[0035] A buffer assembly is also provided between the main belt 1 and the adjusting seat 2. The buffer assembly is used to absorb the external force when the dialysis tube is pulled. The buffer assembly includes a buffer sleeve, a compression spring and a pressure sensor. One end of the buffer sleeve is fixed to the bottom of the adjusting seat 2, and the other end of the buffer sleeve is connected to the main belt 1 through the compression spring to form an axially expandable floating structure. The pressure sensor is embedded inside the buffer sleeve and is used to monitor the pressure value generated by the deformation of the compression spring in real time. The fixing part of the main belt 1 is a Velcro closure 6. The contact surface of the Velcro closure 6 has length scale lines, which are used to precisely adjust the tightness of the main belt 1.
[0036] The specific implementation process is as follows: Medical staff or patients take out the device according to the usage area (such as the thigh), and manually bend the arc-shaped shaping part inside the main belt 1 to make the overall arc of the main belt 1 completely fit the curve of the patient's body. For the thigh area of obese patients, the shaping part is bent into a corresponding convex arc; for the thigh area of thin patients, the shaping part is adjusted to form a suitable concave arc, ensuring that the skin-friendly antibacterial fabric layer of the main belt 1 can fully fit the skin without any local suspension.
[0037] Wrap the shaped main band 1 around the patient's body area where the dialysis catheter puncture site is located, aligning the midpoint of the main band 1 roughly directly above the puncture site. Then, fasten the Velcro fasteners 6 at both ends of the main band 1 together. Using the length markings on the Velcro fasteners 6, adjust the fit length according to the patient's thigh circumference, allowing 1-2 fingers to be inserted comfortably. This ensures stability while avoiding excessive tightness that could cause compression, completing the initial fixation of the main band 1. Slide the adjusting seat 2 along the main band 1 until the center of the self-adaptive clamping mechanism inside the adjusting seat 2 is aligned with the catheter body 3-5 cm outside the dialysis catheter puncture site, ensuring that there is no significant tensile stress between the catheter body and the puncture site after clamping.
[0038] Place the dialysis tubing into the gap between the two arc-shaped clamping blocks 3 inside the adjusting seat 2, ensuring the tubing is horizontal and without bending. Medical staff or the patient manually rotate the butterfly bolt extending to the outside of the adjusting seat 2. Because the guide rod 4 has threads in opposite directions at both ends, rotating the bolt drives the two arc-shaped clamping blocks 3 to move synchronously towards each other along the guide rod 4 until the inner anti-slip silicone pad is completely against the outer wall of the tubing. Continue rotating the bolt, utilizing the wavy anti-slip texture on the surface of the silicone pad to enhance friction, thus completing the clamping and fixing of the dialysis tubing. This clamping method is adaptable to dialysis tubing of various diameters without the need to change the clamping components.
[0039] During dialysis, the compression spring of the buffer assembly absorbs the traction force generated by the patient's turning over, preventing stress from being directly transmitted to the puncture site. The pressure sensor inside the buffer sleeve monitors the spring deformation pressure value in real time. If there is a significant traction action, it prompts the patient to adjust their position to release stress. At the same time, the honeycomb-shaped breathable channels of the main belt 1 work together with the three-layer composite structure to achieve heat dissipation and sweat absorption from the skin, keeping the contact area dry.
[0040] After dialysis, first rotate the butterfly bolt in the opposite direction to make the two arc-shaped clamping blocks 3 move in the opposite direction synchronously, loosen the clamping of the dialysis tube, loosen the positioning bolt 7, slide the adjusting seat 2 along the main belt 1 to the edge and remove it, and then unfasten the Velcro buckles 6 at both ends of the main belt 1 to complete the overall disassembly of the device.
[0041] Example 2:
[0042] The difference from Embodiment 1 is that the adjustment seat 2 is a hollow rectangular structure. The bottom end of the adjustment seat 2 that contacts the skin has several hollow areas, and activated carbon moisture-absorbing sheets can be detachably connected to the hollow areas. The side wall of the adjustment seat 2 has ventilation holes that communicate with the honeycomb-shaped ventilation channels. The ventilation holes are used to form an air convection channel between the main belt 1 and the adjustment seat 2.
[0043] The specific implementation process is as follows: Referring to the method in Example 1, based on the curve of the patient's body at the puncture site, manually bend the arc-shaped shaping component inside the main strap 1 so that the skin-friendly antibacterial fabric layer of the main strap 1 can closely conform to the skin contour. Wrap the shaped main strap 1 around the puncture site, and adjust the position of the main strap 1 with the puncture point as the center to ensure that the honeycomb-shaped ventilation channel of the main strap 1 corresponds to the position of the ventilation hole on the side wall of the adjustment seat 2, reserving a channel for subsequent air convection.
[0044] During dialysis, the honeycomb-shaped ventilation channels of the main belt 1 and the ventilation holes of the adjustment seat 2 create air convection, accelerating heat dissipation from the skin. Some of the sweat and moisture secreted by the skin are absorbed by the absorbent cotton layer of the main belt 1, while the rest is adsorbed by the activated carbon moisture-absorbing sheet through the perforated area, keeping the contact area dry. The compression spring of the buffer assembly absorbs external force, and the pressure sensor monitors the tensile pressure, ensuring the stability of the tubing.
[0045] Example 3:
[0046] The difference from Embodiment 2 is that it also includes a puncture point monitoring module, which includes an annular silicone sealing gasket and a humidity sensor. The annular silicone sealing gasket is arranged around the dialysis tube, with the bottom of the annular silicone sealing gasket in contact with the skin and the top of the annular silicone sealing gasket fixed to the bottom of the adjustment seat 2. The humidity sensor is embedded in the inner wall of the annular silicone sealing gasket and is used to detect humidity changes in the puncture point area.
[0047] It also includes a tube condition monitoring module, which includes a pressure strain gauge. The pressure strain gauge is embedded inside the anti-slip silicone pad on the inner side of the arc-shaped clamping block 3, and the sensing surface of the pressure strain gauge is in contact with the outer wall of the dialysis tube. When the dialysis tube is bent, causing the tube body to deform, the pressure strain gauge can convert the deformation into an electrical signal.
[0048] It also includes an early warning module, which includes a controller, indicator lights, and a buzzer. The controller is electrically connected to the pressure sensor, humidity sensor, pressure strain gauge, indicator lights, and buzzer respectively. When any of the pressure sensor, humidity sensor, or pressure strain gauge detects an abnormal signal, the controller triggers the indicator lights and buzzer.
[0049] The specific implementation process is as follows: Referring to the methods of Example 1 and Example 2, the dialysis tube is passed through the central hole of the annular silicone sealing gasket and placed between two arc-shaped clamping blocks 3. The butterfly bolt is rotated to drive the clamping blocks to move towards each other along the guide rod 4 until the pressure strain gauge sensing surface inside the anti-slip silicone gasket is tightly attached to the outer wall of the dialysis tube. At this time, the initial signal of the pressure strain gauge is stable, and the controller records the initial pressure threshold.
[0050] The controller presets abnormal thresholds for each monitoring module: the tensile pressure threshold for the pressure sensor corresponds to significant external force, the humidity threshold for the humidity sensor corresponds to minor leakage, and the deformation pressure threshold for the strain gauge corresponds to pipe bending and blockage. After the thresholds are set, the controller enters real-time monitoring mode, and the indicator lights are in standby mode.
[0051] During dialysis, the various modules work together: the pressure sensor in the buffer component monitors the pulling force, the humidity sensor monitors bleeding and leakage at the puncture site, and the pressure strain gauge monitors the bending deformation of the dialysis tubing. When the patient turns over, causing traction on the dialysis tubing, and the pressure sensor reading exceeds the pressure threshold, the controller immediately triggers the indicator light to turn red and flash, and the buzzer emits a low-frequency warning sound, prompting the patient to adjust their position. If a small amount of leakage occurs at the puncture site, and the humidity sensor reading exceeds the humidity threshold, the early warning module is activated simultaneously, allowing medical staff to promptly manage the leakage and prevent infection. If the dialysis tubing bends, causing deformation, and the pressure strain gauge signal exceeds the deformation pressure threshold, the early warning system is triggered to quickly check the tubing status and prevent a decrease in dialysis flow.
[0052] Once the warning module is activated, medical staff or patients should first check the indicator light status to confirm the source of the warning and then take appropriate action—for traction warnings, the patient's position needs to be adjusted; for effusion warnings, the puncture site needs to be cleaned and the annular silicone sealing gasket replaced; for tubing bending warnings, the dialysis tubing needs to be straightened and re-clamped. After the action is taken, the controller clears the abnormal signal, the indicator light returns to standby mode, the buzzer stops sounding, and the system re-enters monitoring mode.
[0053] Example 4:
[0054] As attached Figure 3 As shown, the difference from embodiment 3 is that a positioning bolt 7 is provided at the sliding connection between the adjusting seat 2 and the main belt 1, and a positioning hole is provided on the surface of the main belt 1 along the length direction. The positioning bolt 7 passes through the adjusting seat 2 and is threadedly engaged with the positioning hole. The positioning bolt 7 and the positioning hole are used to fix the adjusting seat 2 on the main belt 1.
[0055] The specific implementation process is as follows: Wrap the shaped main belt 1 around the puncture site, so that the center hole of the annular silicone sealing pad is precisely aligned with the puncture point. Then, attach the Velcro buckles 6 at both ends of the main belt 1 along the length scale line and adjust them to a suitable tightness to ensure that the bottom of the annular silicone sealing pad is tightly attached to the skin without gaps.
[0056] First, loosen the positioning bolt 7 on the adjusting seat 2 counterclockwise, so that its end is detached from the surface of the main belt 1. Push the adjusting seat 2 to slide along the length of the main belt 1 until the bottom of the adjusting seat 2 is completely in contact with the top of the annular silicone sealing gasket, and the center of the self-adaptive clamping mechanism is aligned with the stable section of the dialysis tube. Observe the position of the positioning hole on the main belt 1, align the bolt hole on the adjusting seat 2 with the corresponding positioning hole on the main belt 1, and tighten the positioning bolt 7 clockwise until the end of the bolt is completely embedded in the positioning hole. Shake the adjusting seat 2 by hand and there is no displacement, thus completing the stable fixing of the adjusting seat 2.
[0057] Example 5:
[0058] The difference from Embodiment 4 is that the controller has a built-in Bluetooth transmission module, which is used to push abnormal signals to medical terminals and patient mobile devices in real time.
[0059] The specific implementation process is as follows: Activate the Bluetooth function of the medical terminal (such as the nurse station host) and the patient's mobile device (such as a mobile phone), open the accompanying dialysis monitoring APP, and complete device login and identity binding (enter the patient ID and device number). Set the abnormal threshold on the medical terminal, and after setting, synchronize it to the controller. The controller receives the threshold data and stores it.
[0060] During dialysis, the positioning bolt 7 and positioning hole ensure the stability of the adjustment seat 2, and all sensors monitor in real time. When excessive traction, leakage at the puncture point, or tube bending occurs, the controller immediately triggers the indicator light to flash red and the buzzer to sound an alarm. At the same time, the Bluetooth transmission module pushes the abnormality type (such as "leakage at the puncture point"), the time of occurrence, and the device number to the medical terminal and the patient's mobile APP in real time. The medical terminal issues an audible and visual alarm, and the APP pops up a push notification.
[0061] After receiving the alert, medical staff go to the site to handle the abnormality. After handling, they press the device reset button, the controller clears the abnormal state, the indicator light returns to green, and the Bluetooth module simultaneously pushes a "Abnormality resolved" signal to the terminal and APP. After dialysis, the device power is turned off, the butterfly screw and positioning screw 7 are loosened, the device is removed, the annular silicone sealing gasket and moisture-absorbing sheet are discarded, and the device is cleaned and put back into use. The medical staff terminal APP completes the recording and archiving of the dialysis data.
[0062] Example 6:
[0063] The difference from Embodiment 5 is that a QR code / barcode scanning window (with a built-in micro scanning module, such as a CMOS scanning sensor) is embedded in the outer wall of the adjustment base 2. The scanning window is encapsulated with high-transparency waterproof acrylic material, which does not affect the scanning accuracy and is suitable for clinical cleaning and disinfection scenarios. At the same time, an NFC card reader module is integrated inside the adjustment base 2, which is compatible with electronic tag scanning.
[0064] The controller has a built-in embedded barcode scanning and parsing program that can identify the unique device identification code (UDI code) on the dialysis tube packaging or the hospital's custom device code. The controller stores a preset code-parameter mapping table.
[0065] Specifically, before use, medical staff align the UDI code / device code on the temporary hemodialysis tubing packaging with the device's scanning window. The controller automatically recognizes and parses the code information, transmitting it to the controller. If it's an NFC tag, the tag can be directly placed near the NFC sensing area of the adjustment base 2 for identification. Simultaneously, the system automatically records the scanning time, device code, and compatibility parameters, storing them in the controller's local storage module (supporting subsequent export via USB). The scanning records can be linked to patient information, dialysis treatment time periods, and device batches, meeting the regulatory requirements for traceability of medical device use.
[0066] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.
Claims
1. An external fixation device for dialysis catheters used in kidney disease, comprising a main strap (1) for conforming to the human body and an adjustment assembly for fixing the dialysis catheter, characterized in that, The main belt (1) is equipped with an arc-shaped shaping component, and the two ends of the main belt (1) are equipped with detachable fixing parts; the adjustment component includes an adjustment seat (2) that slides with the main belt (1), and the adjustment seat (2) is equipped with an adaptive clamping mechanism. The adaptive clamping mechanism is used to synchronously adjust the clamping distance along the radial direction of the dialysis tube to fix the dialysis tubes of different diameters; a buffer component is also provided between the main belt (1) and the adjustment seat (2). The buffer component is used to absorb the external force when the dialysis tube is pulled.
2. The external fixation device for dialysis catheters in kidney disease according to claim 1, characterized in that, The adaptive clamping mechanism includes two symmetrically arranged arc-shaped clamping blocks (3), a guide rod (4), and an adjusting component (5). The guide rod (4) passes horizontally through the side wall of the adjusting seat (2). The two ends of the guide rod (4) are respectively provided with threads in opposite directions. The arc-shaped clamping blocks (3) are fitted onto the guide rod (4). One end of the guide rod (4) is fixedly engaged with the adjusting component (5). The adjusting component (5) is a butterfly bolt. The end of the adjusting component (5) extends to the outside of the adjusting seat (2). When the butterfly bolt is rotated, the two arc-shaped clamping blocks (3) can be driven to move synchronously in opposite directions along the guide rod (4). The inner side wall of the arc-shaped clamping block (3) is fixedly connected with an anti-slip silicone pad. The surface of the silicone pad is provided with a wavy anti-slip texture.
3. The external fixation device for dialysis catheters in kidney disease according to claim 2, characterized in that, The buffer assembly includes a buffer sleeve, a compression spring and a pressure sensor. One end of the buffer sleeve is fixed to the bottom of the adjusting seat (2), and the other end of the buffer sleeve is connected to the main belt (1) through the compression spring to form a floating structure that can be axially extended and retracted. The pressure sensor is embedded inside the buffer sleeve. The pressure sensor is used to monitor the pressure value generated by the deformation of the compression spring in real time. The fixing part of the main belt (1) is a Velcro buckle (6). The Velcro buckle (6) has a length scale line on its contact surface. The length scale line is used to precisely adjust the tightness of the main belt (1).
4. The external fixation device for dialysis catheters in kidney disease according to claim 3, characterized in that, The main belt (1) is a three-layer composite structure. From the outside to the inside, the main belt (1) consists of a breathable mesh layer, a water-absorbing and sweat-wicking cotton layer, and a skin-friendly antibacterial fabric layer. A honeycomb-shaped breathable channel is provided between the three composite structures. The arc-shaped shaping component is embedded between the water-absorbing and sweat-wicking cotton layer and the skin-friendly antibacterial fabric layer along the length of the main belt (1). The arc-shaped shaping component is used to maintain the curvature that matches the curve of the human body after shaping.
5. The external fixation device for dialysis catheters in kidney disease according to claim 4, characterized in that, The adjustment seat (2) is a hollow rectangular structure. The bottom of the adjustment seat (2) has several hollow areas on the end face that contacts the skin. Activated carbon moisture-absorbing sheets can be detachably connected in the hollow areas. The side wall of the adjustment seat (2) is provided with ventilation holes that communicate with the honeycomb ventilation channel. The ventilation holes are used to form an air convection channel between the main belt (1) and the adjustment seat (2).
6. The external fixation device for dialysis catheters in kidney disease according to claim 5, characterized in that, It also includes a puncture point monitoring module, which includes an annular silicone sealing pad and a humidity sensor. The annular silicone sealing pad is set around the dialysis tube, the bottom of the annular silicone sealing pad is in contact with the skin, and the top of the annular silicone sealing pad is fixed to the bottom of the adjustment seat (2). The humidity sensor is embedded in the inner wall of the annular silicone sealing pad and is used to detect the humidity change in the puncture point area.
7. The external fixation device for dialysis catheters in kidney disease according to claim 6, characterized in that, It also includes a tube condition monitoring module, which includes a pressure strain gauge. The pressure strain gauge is embedded in the anti-slip silicone pad inside the arc-shaped clamping block (3). The sensing surface of the pressure strain gauge is in contact with the outer wall of the dialysis tube. When the dialysis tube is bent, causing the tube body to deform, the pressure strain gauge can convert the deformation into an electrical signal.
8. The external fixation device for dialysis catheters in kidney disease according to claim 7, characterized in that, It also includes an early warning module, which includes a controller, indicator lights, and a buzzer. The controller is electrically connected to the pressure sensor, humidity sensor, pressure strain gauge, indicator lights, and buzzer respectively. When any of the pressure sensor, humidity sensor, or pressure strain gauge detects an abnormal signal, the controller triggers the indicator lights and buzzer.
9. The external fixation device for dialysis catheters in kidney disease according to claim 8, characterized in that, A positioning bolt (7) is provided at the sliding connection between the adjusting seat (2) and the main belt (1). A positioning hole is provided on the surface of the main belt (1) along the length direction. The positioning bolt (7) passes through the adjusting seat (2) and cooperates with the positioning hole. The positioning bolt (7) and the positioning hole are used to fix the adjusting seat (2) on the main belt (1).
10. The external fixation device for dialysis catheters in kidney disease according to claim 9, characterized in that, The controller has a built-in Bluetooth transmission module, which is used to push abnormal signals to medical terminals and patient mobile devices in real time.