Infusion leakage monitoring device based on bioelectrical impedance

Abstract

The invention discloses an infusion leakage monitoring device based on bioelectrical impedance, and relates to the technical field of medical instruments. The electrode main line is mounted on one side of the outer wall of the monitoring control box; the flexible electrode patch is mounted at the other end of the electrode main line; through cooperative work of the flexible substrate layer, the electrode and wire layer, the packaging and protection layer, the skin contact layer and the window filling body, a plurality of electrode contacts in the electrode and wire layer can accurately capture tissue electrical impedance subtle changes caused by early-stage leakage, timely early warning is achieved, the packaging and protection layer can isolate external interference, and the skin leakage can be prevented. The flexible substrate layer is matched with the skin contact layer, the flexible substrate layer can be tightly attached to the small limb contours of special patients such as newborns, skin irritation or allergy is avoided by means of excellent biocompatibility, and the use safety and clinical suitability of the device are comprehensively improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an infusion leakage monitoring device based on bioelectrical impedance. Background Technology

[0002] Infusion leakage refers to the phenomenon where fluid leaks from the intravenous infusion tubing into the surrounding tissue spaces due to various reasons during intravenous infusion. This is quite common in clinical nursing, especially in children, elderly patients, patients receiving long-term infusions, or patients with poor vascular conditions. Infusion leakage not only reduces the effectiveness of infusion therapy but can also lead to a series of complications, such as local tissue edema, pain, redness, swelling, skin necrosis, and even affect peripheral nerve function in severe cases, causing additional suffering and medical burden to patients. Therefore, real-time monitoring of infusion leakage is necessary to ensure patient treatment safety and recovery progress.

[0003] Chinese patent CN219307577U discloses a device for preventing leakage in intravenous infusion. The device uses a humidity sensor to continuously detect whether leakage has occurred. At the same time, the control chip can determine whether leakage has occurred based on the humidity signal transmitted by the humidity sensor. When the control chip determines that leakage has occurred, it can promptly alert the patient to the leakage through an alarm indicator light and ask the patient to seek help from a nurse.

[0004] Existing leakage monitoring devices have low sensitivity to early leakage detection, making it difficult to provide timely warnings. In addition, the biocompatibility and flexibility of the materials are insufficient, and long-term contact can easily cause local irritation or allergic reactions in patients with sensitive skin, which seriously affects the reliability of monitoring and the safety of patients. Summary of the Invention

[0005] The purpose of this invention is to provide an infusion leakage monitoring device based on bioelectrical impedance to solve the problems of low sensitivity in early leakage detection, insufficient device flexibility and biocompatibility in the prior art.

[0006] To achieve the above objectives, the present invention provides the following technical solution: an infusion leakage monitoring device based on bioelectrical impedance, comprising a monitoring and control box;

[0007] The electrode main line is installed on one side of the outer wall of the monitoring and control box;

[0008] A flexible electrode patch is installed at the other end of the electrode main line;

[0009] The flexible electrode patch includes a flexible substrate layer, an electrode and wire layer, an encapsulation and protection layer, a skin contact layer, and multiple window fillers. The electrode and wire layer is embedded inside the flexible substrate layer, the encapsulation and protection layer is installed at the top of the flexible substrate layer, the skin contact layer is installed at the bottom of the flexible substrate layer, and the multiple window fillers are all disposed at the top of the skin contact layer.

[0010] The electrode and conductor layer includes a conductor connector, multiple flexible conductors, and multiple electrode contacts. The conductor connector is installed at the end of the electrode main line away from the monitoring and control box. The multiple flexible conductors are all installed inside the conductor connector, and the multiple electrode contacts are respectively installed at the other end of each flexible conductor.

[0011] A fixing mechanism is fitted onto the outer wall of the electrode main wire;

[0012] The controller main line is installed on the other side of the outer wall of the monitoring and control box;

[0013] An operation controller is installed at the other end of the controller main line.

[0014] Furthermore, the flexible electrode patch also includes multiple mounting ports, multiple contact windows, and multiple wire grooves. The multiple mounting ports are all located at the top of the flexible substrate layer, the multiple contact windows are all located at the bottom of the flexible substrate layer, and the multiple wire grooves are all located inside the flexible substrate layer and communicate with the corresponding mounting ports.

[0015] Furthermore, the fixing mechanism includes a fixing sleeve, a positioning member, two hook and loop fasteners and two barbed fasteners. The positioning member is installed on one side of the top of the fixing sleeve, the two hook and loop fasteners are embedded on the other two sides of the top of the fixing sleeve, and the two barbed fasteners are installed on both sides of one end of the fixing sleeve, and the barbed fasteners are glued and fixed to the corresponding hook and loop fasteners.

[0016] Furthermore, the fixing mechanism also includes an observation window, a lighting strip, two fixing films, and a limiting sleeve. The observation window is located at the top center of the fixing sleeve. The lighting strip is embedded in the middle of the inner wall of the observation window. The two fixing films are respectively installed on the upper and lower sides of the inner wall of the observation window. The limiting sleeve is installed at the bottom rear side of the observation window and is fitted onto the outer wall of the electrode main line.

[0017] Furthermore, the positioning component includes an infusion tube positioning pad, an intermediate positioning groove, a first slot, and a second slot. The infusion tube positioning pad is installed on the top of the fixing sleeve. The intermediate positioning groove is located in the middle of the top of the infusion tube positioning pad. The first slot is located on the front side of the top of the infusion tube positioning pad. The second slot is located on the rear side of the top of the infusion tube positioning pad.

[0018] Furthermore, the monitoring and control box is internally equipped with an excitation circuit, a measurement circuit, a signal processing module, a control module, a power supply module, and an alarm module. The excitation circuit and the signal processing module are both connected to the measurement circuit, and the control module is connected to both the signal processing module and the alarm module.

[0019] Furthermore, the contact window is located directly below and communicates with the corresponding mounting port. The inner diameter of the contact window is larger than the outer diameter of the mounting port. The skin contact layer adopts a gradually thinning edge design. The material of the window filler is the same as the material of the skin contact layer, and the window filler fills the interior of the contact window and contacts the electrode contact.

[0020] Furthermore, the diameter of the observation window is larger than the diameter of the flexible electrode patch, the first and second slots are both L-shaped, the lighting strip is electrically connected to the monitoring and control box, and the fixing film is made of medical-grade transparent polyurethane film.

[0021] Furthermore, the control module includes a software algorithm, the power module uses a rechargeable lithium battery or a button battery, and the alarm module includes a buzzer and an LED indicator.

[0022] Compared with the prior art, the beneficial effects of the present invention are:

[0023] (1) Through the coordinated work of the flexible base layer, electrode and wire layer, encapsulation and protection layer, skin contact layer and window filler, the multiple electrode contacts in the electrode and wire layer can accurately capture the subtle changes in tissue impedance caused by early leakage, so as to achieve timely warning. The encapsulation and protection layer can isolate external interference, ensure stable signal acquisition and reliable monitoring. The flexible base layer combined with the skin contact layer can not only closely fit the small limb contours of special patients such as newborns, but also avoid skin irritation or allergies due to excellent biocompatibility, thus comprehensively improving the safety and clinical suitability of the device.

[0024] (2) The present invention solves the problem of monitoring interruption caused by the lack of fixation of existing devices by working together with components such as the fixing sleeve, positioning component, Velcro surface and barbed surface fixing band. The positioning component fixes the infusion tube into an S-shape to prevent the catheter from being accidentally pulled when the child moves. The Velcro surface and barbed surface fixing band can be glued together to adjust the tightness of fixation according to the thickness of the patient's limb, ensuring that the device fits the limb tightly and preventing the electrode patch from shifting or falling off. At the same time, the flexible structure design is adapted to the small limb contour of newborns.

[0025] (3) The present invention utilizes the coordinated operation of an excitation circuit, a measurement circuit, a signal processing module, a control module, a power supply module, and an alarm module. The power supply module provides a continuous and stable power supply, the excitation circuit outputs a safe low-frequency excitation signal, the measurement circuit accurately collects tissue impedance signals and transmits them to the signal processing module for filtering and amplification, and the control module analyzes signal changes through built-in software algorithms to quickly identify early leakage characteristics. Once an abnormality is detected, the alarm module immediately triggers the buzzer to sound and the LED indicator to flash, further solving the problems of low sensitivity and untimely early leakage identification in existing devices. Attached Figure Description

[0026] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this invention. For those skilled in the art, other drawings can be obtained based on these drawings.

[0027] Figure 1 This is a schematic diagram of the overall structure provided for an embodiment of the present invention;

[0028] Figure 2 A schematic diagram of the overall structure without the fixing mechanism is provided for an embodiment of the present invention;

[0029] Figure 3 An exploded view of the flexible electrode patch structure is provided for an embodiment of the present invention;

[0030] Figure 4 A schematic diagram of the electrode and conductor layer is provided for embodiments of the present invention;

[0031] Figure 5 A structural cross-sectional view of the flexible substrate layer is provided for embodiments of the present invention;

[0032] Figure 6 A structural schematic diagram of the fixing mechanism is provided for an embodiment of the present invention;

[0033] Figure 7 A schematic diagram of the connection between the positioning element and the infusion tube is provided for an embodiment of the present invention;

[0034] Figure 8 A diagram showing the internal structure of the monitoring and control box is provided for embodiments of the present invention.

[0035] Explanation of reference numerals in the attached figures:

[0036] 1. Monitoring and control box; 2. Electrode main line; 3. Flexible electrode patch; 4. Fixing mechanism; 5. Controller main line; 6. Operation controller; 7. Excitation circuit; 8. Measurement circuit; 9. Signal processing module; 10. Control module; 11. Power supply module; 12. Alarm module; 31. Flexible substrate layer; 32. Electrode and wire layer; 33. Encapsulation and protection layer; 34. Skin contact layer; 35. Window filler; 36. Mounting port; 37. Contact window; 38. Wire groove; 321. Wire connector; 322. Flexible wire; 323. Electrode contact; 41. Fixing sleeve; 42. Positioning component; 43. Velcro surface; 44. Spiked fixing strap; 45. Observation window; 46. Illumination strip; 47. Fixing film; 48. Limiting sleeve; 421. Infusion tube positioning pad; 422. Intermediate positioning groove; 423. First slot; 424. Second slot. Detailed Implementation

[0037] To enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings.

[0038] As attached Figure 1 To be continued Figure 8 As shown:

[0039] Example 1:

[0040] This invention provides an infusion leakage monitoring device based on bioelectrical impedance, including a monitoring and control box 1;

[0041] Electrode main line 2 is installed on one side of the outer wall of monitoring and control box 1. It adopts medical-grade flexible shielded wire to ensure stable signal transmission and has anti-pulling performance.

[0042] The flexible electrode patch 3 is installed at the other end of the electrode main line 2, with an overall thickness controlled within 1mm to ensure comfortable application.

[0043] The flexible electrode patch 3 includes a flexible base layer 31, an electrode and wire layer 32, an encapsulation and protection layer 33, a skin contact layer 34, and multiple window fillers 35. The flexible base layer 31 is made of polyimide. The electrode and wire layer 32 is embedded inside the flexible base layer 31. The encapsulation and protection layer 33 is installed on the top of the flexible base layer 31. The encapsulation and protection layer 33 is made of medical-grade liquid silicone or soft polyurethane. Its top edge is designed with a smooth curved transition. The skin contact layer 34 is installed at the bottom of the flexible base layer 31. The skin contact layer 34 is made of medical-grade high water retention and conductive hydrogel. Multiple window fillers 35 are all located on the top of the skin contact layer 34.

[0044] The electrode and wire layer 32 includes a wire connector 321, multiple flexible wires 322, and multiple electrode contacts 323. The wire connector 321 is installed at the end of the electrode main line 2 away from the monitoring and control box 1. The multiple flexible wires 322 are all installed inside the wire connector 321. The flexible wires 322 are all made of silver paste conductive material. The multiple electrode contacts 323 are respectively installed at the other end of each flexible wire 322.

[0045] The fixing mechanism 4 is sleeved on the outer wall of the electrode main line 2 and adopts a lightweight and flexible structure to fix the position of the flexible electrode patch 3.

[0046] The controller main line 5 is installed on the other side of the outer wall of the monitoring and control box 1. It also uses medical-grade wires for easy hand-held operation by medical staff.

[0047] The operation controller 6 is installed at the other end of the controller main line 5 and integrates power switch, mode selection, parameter adjustment and status display functions.

[0048] The flexible electrode patch 3 also includes multiple mounting ports 36, multiple contact windows 37, and multiple wire grooves 38. The multiple mounting ports 36 are all located at the top of the flexible substrate layer 31, the multiple contact windows 37 are all located at the bottom of the flexible substrate layer 31, and the multiple wire grooves 38 are all located inside the flexible substrate layer 31 and communicate with the corresponding mounting ports 36.

[0049] The contact window 37 is located directly below and communicates with the corresponding mounting port 36, providing a channel for the installation and exposure of the electrode contact 323. This communication ensures that the electrode contact 323 can indirectly contact the skin through the window filler 35, achieving effective acquisition of impedance signals. The inner diameter of the contact window 37 is larger than the outer diameter of the mounting port 36, forming a stepped limiting structure. This facilitates the filling and fixing of the window filler 35, preventing it from falling off the mounting port 36, and provides sufficient contact space for the electrode contact 323, ensuring a complete fit between the electrode contact 323 and the window filler 35, reducing signal transmission loss. The skin contact layer 34 adopts a tapered edge design, which ensures a smooth skin contact. The edge thickness of the contact layer 34 is less than that of the central area, reducing gaps and pressure between the edge and the skin, preventing the flexible electrode patch 3 from lifting due to patient movement, and improving the fit to the contours of small limbs such as newborns, ensuring comfort and safety during long-term wear. The material of the window filler 35 is the same as that of the skin contact layer 34. The same material can avoid skin irritation caused by contact between different materials and improve biocompatibility. The window filler 35 fills the interior of the contact window 37 and contacts the electrode contact 323, which can realize the conduction of impedance signals between the electrode contact 323 and the skin, and protect the electrode contact 323 from direct friction with the skin, reducing the risk of skin damage.

[0050] Working principle: In use, the flexible electrode patch 3 is first attached to the patient's infusion site. The skin contact layer 34 contacts the patient first, and its tapered edge design improves the comfort of the fit. The window filler 35 fills the contact window 37 and makes close contact with the electrode contact 323 to ensure the stability of signal transmission. At the same time, the flexible base layer 31, with its good flexibility and conformity to the limb contour, can not only closely fit the small limb contours of special patients such as newborns, but also completely improves the shortcomings of insufficient flexibility and poor fit of traditional devices. It also avoids skin irritation or allergic reactions due to its excellent biocompatibility. The electrode and lead wire layer 32 is fixedly connected to the electrode main line 2 through the lead wire connector 321 and is installed inside the flexible base layer 31 through an embedded process. The flexible lead wire 322 is arranged through the lead wire groove 38, and multiple electrode contacts 323 are in contact with the patient's skin through the window filler 35. Indirect contact significantly reduces signal transmission loss, enabling the device to accurately capture subtle changes in tissue impedance caused by early leakage, achieving timely early warning and significantly improving the sensitivity of early leakage identification. Medical staff issue commands through the controller 6, which are transmitted to the monitoring control box 1 via the controller main line 5. The excitation circuit 7 in the monitoring control box 1 drives the electrode contacts 323 to apply a safety excitation signal to the subcutaneous tissue. At the same time, the measurement circuit 8 collects tissue impedance signals in real time. When infusion leakage occurs, changes in tissue fluid will cause fluctuations in the impedance signal, thus providing data support for subsequent early warning. The encapsulation and protective layer 33 is made of medical-grade liquid silicone or soft polyurethane material to achieve sealing protection of the internal structure, isolating external sweat, dust and other interference, further ensuring the stability of signal acquisition and monitoring reliability, and comprehensively improving the safety and clinical adaptability of the device.

[0051] Example 2:

[0052] This embodiment is basically the same as the previous embodiment, except that the fixing mechanism 4 includes a fixing sleeve 41, a positioning member 42, two Velcro loops 43 and two barbed fixing straps 44. The fixing sleeve 41 is made of medical-grade transparent polyurethane material. The positioning member 42 is installed on one side of the top of the fixing sleeve 41. The two Velcro loops 43 are embedded on the other two sides of the top of the fixing sleeve 41. The two barbed fixing straps 44 are installed on one side of one end of the fixing sleeve 41. The barbed fixing straps 44 are made of high-toughness medical nylon material, and the barbed fixing straps 44 are glued and fixed to the corresponding Velcro loops 43. The bonding strength can be adjusted by the wrapping length to adapt to limbs of different thicknesses.

[0053] The fixing mechanism 4 also includes an observation window 45, a lighting strip 46, two fixing films 47, and a limiting sleeve 48. The observation window 45 is located at the top center of the fixing sleeve 41. The lighting strip 46 is embedded in the middle of the inner wall of the observation window 45 and uses low-power LED cold light beads. The light is soft and not dazzling and does not generate obvious heat, so as to avoid burning the patient's skin. The two fixing films 47 are respectively installed on the upper and lower sides of the inner wall of the observation window 45. The limiting sleeve 48 is installed on the bottom rear side of the observation window 45 and is made of flexible silicone material. The limiting sleeve 48 is fitted on the outer wall of the electrode main line 2.

[0054] The positioning component 42 includes an infusion tube positioning pad 421, an intermediate positioning groove 422, a first slot 423, and a second slot 424. The infusion tube positioning pad 421 is installed on the top of the fixing sleeve 41. The intermediate positioning groove 422 is opened in the middle of the top of the infusion tube positioning pad 421. The first slot 423 is opened on the front side of the top of the infusion tube positioning pad 421. The second slot 424 is opened on the rear side of the top of the infusion tube positioning pad 421.

[0055] The diameter of the observation window 45 is larger than the diameter of the flexible electrode patch 3, ensuring that medical staff can fully see the attachment status of the flexible electrode patch 3 and the skin condition at the infusion site, avoiding the omission of abnormalities due to limited field of view. Both the first and second slots 423 and 424 are L-shaped, allowing the infusion tube to be fixed by the L-shaped bend after insertion, preventing the tube from falling out during patient movement and avoiding accidental pulling that could cause needle displacement or device damage. The lighting strip 46 is electrically connected to the monitoring and control box 1. The power module 11 obtains power and is controlled to turn on / off by the operation controller 6 or the control module 10. It provides soft lighting in dimly lit environments such as wards at night. Together with the observation window 45, it allows medical staff to clearly observe the infusion site. The fixation film 47 is made of medical-grade transparent polyurethane film. The medical-grade material ensures safety when in contact with the human body and avoids skin irritation. Its transparency does not affect the clarity of the field of view of the observation window 45. At the same time, it can block dust, sweat and other external impurities from contacting the lighting strip 46, thus protecting the lighting strip 46 and extending its service life.

[0056] Working principle: In use, after the flexible electrode patch 3 is attached to the patient's infusion site, the device is stably installed and provides auxiliary observation functions through the fixing mechanism 4. The limiting sleeve 48 is fitted on the outer wall of the electrode main line 2, limiting the position of the fixing sleeve 41. Then, the fixing sleeve 41 is tightly fixed to the patient's limb by the adhesive cooperation of the pierced fixing band 44 and the hook and loop fastener 43, preventing the device from shifting due to patient movement. The tightness of the fixation can be flexibly adjusted according to the thickness of the patient's limb to ensure that the device fits the limb tightly and prevent the electrode patch from shifting or falling off. On the infusion tube positioning pad 421 of the positioning component 42, the middle positioning groove 422, the L-shaped first slot 423 and the second slot 424 can respectively limit and fix the infusion tube in multiple directions, fixing the infusion tube in an S-shape on the positioning component 42. At the same time, the pierced fixing band 44 and the hook and loop fastener 43 are also used to fix the device. When the flexible electrode patch 3 is applied, it also helps to fix the infusion tube, thus achieving a firm and limited fixation of the infusion tube and preventing it from being accidentally pulled when the child moves. This effectively solves the problem of monitoring interruption caused by the lack of fixation in existing devices. At the same time, the observation window 45 can clearly expose the monitoring area, and the fixation film 47 made of medical-grade transparent polyurethane film can protect the internal structure. The lighting strip 46 is electrically connected to the monitoring control box 1 and can be manually or automatically turned on in dim environments such as wards at night, making it convenient for medical staff to observe the infusion site in real time. This structure not only solves the problems of the device being not firmly fixed and the infusion tube being easily pulled, but also improves the convenience of clinical operation through the lighting and transparent observation design. Combined with the adhesion and signal acquisition function of the flexible electrode patch 3, it further ensures the continuity and stability of the monitoring process and improves the clinical applicability of the device.

[0057] Example 3:

[0058] This embodiment is basically the same as the previous embodiment, except that the monitoring and control box 1 is internally equipped with an excitation circuit 7, a measurement circuit 8, a signal processing module 9, a control module 10, a power supply module 11, and an alarm module 12. The excitation circuit 7 adopts a low-frequency sine wave excitation design to ensure that it is safe and non-stimulating to the human body. The excitation circuit 7 and the signal processing module 9 are both connected to the measurement circuit 8. The control module 10 is connected to the signal processing module 9 and the alarm module 12 respectively. The control module 10 adopts a high-performance microprocessor to realize fast signal transmission and command execution.

[0059] The control module 10 contains a software algorithm that analyzes, processes, and identifies the tissue impedance signal collected by the measurement circuit 8. This algorithm accurately distinguishes between normal tissue signals and abnormal signals caused by infusion leakage, providing a logical basis for leakage judgment and determining the sensitivity and accuracy of monitoring. The power module 11 uses a rechargeable lithium battery or a button battery to provide power to all electrical components in the monitoring and control box 1, including the excitation circuit 7, measurement circuit 8, and signal processing module 9, as well as peripherals such as the lighting strip 46 and alarm module 12. The choice between rechargeable lithium batteries and button batteries can adapt to different usage scenarios, ensuring that the device can work normally even without an external power source. The alarm module 12 includes a buzzer and an LED indicator. When the control module 10 determines that infusion leakage has occurred, the buzzer of the alarm module 12 emits sound (auditory reminder), and the LED indicator flashes or changes color (visual reminder), sending a dual warning signal to medical staff or patients to ensure that the leakage is detected in time and to avoid delays in treatment.

[0060] Working Principle: During use, the power module 11 provides continuous power to the entire device. After medical staff issues a start command through the operation controller 6, the excitation circuit 7 in the monitoring and control box 1 drives the electrode contacts 323 to apply a safe low-frequency excitation signal to the patient's subcutaneous tissue via the electrode main line 2 and flexible wire 322. The measurement circuit 8 collects the tissue impedance signal in real time and transmits it to the signal processing module 9 for filtering, amplification, and other processing. The processed signal is sent to the control module 10 with built-in software algorithm. The control module 10 analyzes and judges the impedance data to quickly identify early leakage characteristics. When the control module 10 detects abnormal fluctuations in the impedance signal due to infusion leakage, it will immediately trigger the buzzer of the alarm module 12 to sound and the LED indicator to flash, realizing dual early warning. This completely solves the problems of low sensitivity and untimely early leakage identification in existing devices, greatly improves the accuracy, timeliness, and reliability of infusion leakage monitoring, and effectively protects the patient's infusion safety.

[0061] The foregoing has only described certain exemplary embodiments of the present invention by way of illustration. Undoubtedly, those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the foregoing drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. A bioelectrical impedance-based infusion leakage monitoring device, characterized in that, include: Monitoring and control box (1); The electrode main line (2) is installed on one side of the outer wall of the monitoring and control box (1); A flexible electrode patch (3) is installed at the other end of the electrode main line (2); The flexible electrode patch (3) includes a flexible substrate layer (31), an electrode and wire layer (32), an encapsulation and protection layer (33), a skin contact layer (34), and multiple window fillers (35). The electrode and wire layer (32) is embedded inside the flexible substrate layer (31), the encapsulation and protection layer (33) is installed at the top of the flexible substrate layer (31), the skin contact layer (34) is installed at the bottom of the flexible substrate layer (31), and the multiple window fillers (35) are all disposed at the top of the skin contact layer (34). The electrode and wire layer (32) includes a wire connector (321), multiple flexible wires (322) and multiple electrode contacts (323). The wire connector (321) is installed at the end of the electrode main line (2) away from the monitoring and control box (1). The multiple flexible wires (322) are all installed inside the wire connector (321). The multiple electrode contacts (323) are respectively installed at the other end of each flexible wire (322). The fixing mechanism (4) is sleeved on the outer wall of the electrode main line (2); The controller main line (5) is installed on the other side of the outer wall of the monitoring and control box (1); An operation controller (6) is installed at the other end of the controller main line (5).

2. The infusion leakage monitoring device based on bioelectrical impedance according to claim 1, characterized in that, The flexible electrode patch (3) also includes multiple mounting ports (36), multiple contact windows (37), and multiple wire grooves (38). The multiple mounting ports (36) are all located at the top of the flexible substrate (31), the multiple contact windows (37) are all located at the bottom of the flexible substrate (31), and the multiple wire grooves (38) are all located inside the flexible substrate (31) and communicate with the corresponding mounting ports (36).

3. The infusion leakage monitoring device based on bioelectrical impedance according to claim 1, characterized in that, The fixing mechanism (4) includes a fixing sleeve (41), a positioning member (42), two hook and loop fasteners (43) and two barbed fasteners (44). The positioning member (42) is installed on one side of the top of the fixing sleeve (41). The two hook and loop fasteners (43) are embedded on the other two sides of the top of the fixing sleeve (41). The two barbed fasteners (44) are installed on one side of one end of the fixing sleeve (41) and are attached and fixed to the corresponding hook and loop fasteners (43).

4. The infusion leakage monitoring device based on bioelectrical impedance according to claim 3, characterized in that, The fixing mechanism (4) also includes an observation window (45), a lighting strip (46), two fixing films (47) and a limiting sleeve (48). The observation window (45) is opened at the top center of the fixing sleeve (41). The lighting strip (46) is embedded in the middle of the inner wall of the observation window (45). The two fixing films (47) are respectively installed on the upper and lower sides of the inner wall of the observation window (45). The limiting sleeve (48) is installed on the bottom rear side of the observation window (45) and is fitted on the outer wall of the electrode main line (2).

5. The infusion leakage monitoring device based on bioelectrical impedance according to claim 4, characterized in that, The positioning component (42) includes an infusion tube positioning pad (421), an intermediate positioning groove (422), a first slot (423), and a second slot (424). The infusion tube positioning pad (421) is installed on the top of the fixing sleeve (41). The intermediate positioning groove (422) is opened in the middle of the top of the infusion tube positioning pad (421). The first slot (423) is opened on the front side of the top of the infusion tube positioning pad (421). The second slot (424) is opened on the rear side of the top of the infusion tube positioning pad (421).

6. The infusion leakage monitoring device based on bioelectrical impedance according to claim 1, characterized in that, The monitoring and control box (1) is internally equipped with an excitation circuit (7), a measurement circuit (8), a signal processing module (9), a control module (10), a power supply module (11), and an alarm module (12). The excitation circuit (7) and the signal processing module (9) are both connected to the measurement circuit (8), and the control module (10) is connected to the signal processing module (9) and the alarm module (12) respectively.

7. The infusion leakage monitoring device based on bioelectrical impedance according to claim 2, characterized in that, The contact window (37) is located directly below and communicates with the corresponding mounting port (36). The inner diameter of the contact window (37) is larger than the outer diameter of the mounting port (36). The skin contact layer (34) adopts a tapered edge design. The material of the window filler (35) is the same as that of the skin contact layer (34), and the window filler (35) fills the interior of the contact window (37) and contacts the electrode contact (323).

8. The infusion leakage monitoring device based on bioelectrical impedance according to claim 5, characterized in that, The diameter of the observation window (45) is larger than the diameter of the flexible electrode patch (3). The first slot (423) and the second slot (424) are both set as L-shaped structures. The lighting strip (46) is electrically connected to the monitoring and control box (1). The fixing film (47) is made of medical grade transparent polyurethane film.

9. The infusion leakage monitoring device based on bioelectrical impedance according to claim 6, characterized in that, The control module (10) contains a software algorithm, the power module (11) uses a rechargeable lithium battery or a button battery, and the alarm module (12) includes a buzzer and an LED indicator.

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