Extravasation detection device based on skin deformation sensor

Abstract

The application relates to the technical field of medical devices, in particular to an exosmosis detection device based on a skin deformation sensor, which comprises an induction assembly and a terminal assembly; the induction assembly and the terminal assembly work cooperatively through wireless communication; the induction assembly comprises an exosmosis detection patch and a signal assembly; a stress induction layer is arranged in the exosmosis detection patch; a stress induction link is arranged in the stress induction layer; the stress induction link converts the change of skin tension into the change of electromagnetic signal feedback output. The exosmosis detection device provided by the application is convenient for remote operation of medical staff, and is suitable for exosmosis detection in various injection scenes.

Description

Technical Field

[0001] This invention relates to the field of intravenous injection technology, specifically to an extravasation detection device based on a skin deformation sensor. Background Technology

[0002] Extravasation is inevitable during intravenous injection, causing complications such as tissue damage, hematoma, and infection. This is especially true when using high-pressure injectors, where the high flow rate and strong backflow increase the risk of needle deviation, posing a greater danger. Therefore, rapid detection of extravasation facilitates timely medical intervention and prevents adverse events.

[0003] Chinese patent application CN115445025 discloses a method, device, and injection system for detecting extravasation of injectable solutions. The method includes: acquiring impedance information of biological tissue; acquiring information on the change in impedance information relative to a reference impedance value; and determining extravasation information based on the change information. This method can quickly detect extravasation and determine the type and amount of extravasated injection solution. However, this approach uses an excitation electrode to apply an excitation signal to the biological tissue and then calculates the impedance information by collecting the signal from the tissue after stimulation. During high-pressure injection, the patient's arm or the back of their hand already experiences high liquid pressure; applying an excitation signal at this time results in a complex and mixed biological signal received by the measuring device, which is not conducive to accurate measurement of bioimpedance.

[0004] Chinese patent CN113230491B discloses a method and apparatus for detecting contrast agent extravasation in CT scans using a camera and pressure sensor. The apparatus includes a wearable device with a miniature camera, processor unit, data transceiver unit, and casing. Image data captured by the miniature camera is transmitted to a monitoring terminal, where medical personnel visually inspect the images to determine if extravasation is present. This approach relies on the experience of medical personnel and is limited by image transmission accuracy, making it unsuitable for early detection of extravasation.

[0005] Chinese patent CN216022453U discloses a method and apparatus for detecting contrast agent extravasation using an infrared sensor. It monitors extravasation by real-time laser scanning of the injection area and observing changes in skin smoothness. This method involves complex equipment, requiring minimal obstruction between the laser scanning device and the injection area skin, and necessitates a large space constraint. Summary of the Invention

[0006] The purpose of this invention is to provide an extravasation detection device based on a skin deformation sensor to solve the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] The extravasation detection device based on skin deformation sensor includes: a sensing component and a terminal component; the sensing component and the terminal component work together via wireless communication.

[0009] The sensing component includes an external leakage detection patch and a signal component;

[0010] The extravasation detection patch has a stress-sensing layer inside, and a stress-sensing link inside the stress-sensing layer. The stress-sensing link converts changes in skin tension into changes in electromagnetic signals and outputs them back. The extravasation detection patch has a link interface, which serves as a bus channel connecting the stress-sensing link and the signal component.

[0011] The signal component is detachably connected to the link interface; the signal component internally includes a miniature power module, a signal processing module, a wireless communication module, and an alarm module, used for signal reception, data processing, signal transmission, and alarm sending;

[0012] The terminal component is a console device used for signal reception, data processing, alarms, and injection program control.

[0013] Preferably, the extravasation detection patch further includes an insulating layer, an adhesive layer, and a dustproof film.

[0014] Preferably, the stress-sensing layer has a multi-layer structure, which is divided into a retaining layer, an uplink layer and a downlink layer from top to bottom; the retaining layer is provided with a memory sheet, which has a corresponding deformation retention function according to the degree of external force; the retaining layer is fixedly connected to the uplink layer, and the uplink layer and the downlink layer can be detachably connected.

[0015] Preferably, the uplink layer contains uplinks, and the downlink layer contains downlinks. The uplinks and downlinks are arranged according to a row and column matrix. Adjacent uplinks are insulated from each other. Adjacent downlinks are insulated from each other. The uplinks and downlinks are insulated from each other on the row and column lines, and contact points are provided only at the intersection points for vertical connection. The uplinks, downlinks, and contact points together form a contact-type matrix sensing link.

[0016] Preferably, the stress-sensing layer is a single-layer structure with a baseline link and a breakpoint link inside.

[0017] Preferably, the baseline link is a conductive path arranged in a uniform "V" shaped array, and several rows of breakpoint links are evenly distributed laterally along the longitudinal column of the baseline link; a breakpoint is set at the intersection of the breakpoint link and the baseline link, one end of the breakpoint link is fixedly connected to the baseline link at the intersection, and the other end of the breakpoint link can be freely separated from the baseline link at the intersection; the baseline link, the breakpoint link and the breakpoint together form a breakpoint matrix sensing link.

[0018] Preferably, the stress-sensing layer is a single-layer structure with a deformation link inside.

[0019] Preferably, the deformation link is made of an electrically sensitive conductive material and consists of a conductive path arranged in a "W" shape.

[0020] Extravasation detection method based on skin deformation sensor extravasation detection device includes the following steps:

[0021] S1. Preparation: Align the center point of the extravasation detection patch with the injection point and attach it tightly to the skin of the injection area. Install the disinfected signal component on the link interface of the extravasation detection patch and turn on the signal switch to establish a wireless connection with the terminal component.

[0022] S2. Initialization: Start the injection control program on the terminal component, record the stress sensing link current information fed back by the signal component before injection, and confirm the current change threshold range for starting and stopping the injection program.

[0023] S3. Start injection and manage the automated injection process: The signal component provides real-time feedback of the stress sensing link current information. The injection control program on the terminal component compares the real-time current information with the current information before injection and calculates the current change value in real time. When the current change value exceeds the threshold, the specific bulge volume is calculated, and alarm information is sent to the signal component and the medical control console respectively. At the same time, the injection device is controlled to stop the injection.

[0024] S4. Medical staff check for abnormal alarms and handle them. After clearing the alarm, they confirm whether to continue the injection.

[0025] S5. Injection completed or terminated, process ends.

[0026] Compared with the prior art, the beneficial effects of the present invention are:

[0027] 1. This invention provides a highly feasible stress sensing link approach that converts changes in skin tension into electromagnetic signal changes for feedback output. It also provides two structures: a matrix stress sensing link and a serpentine link stress sensing link. This approach causes minimal skin irritation in the injection area, requires minimal detection space, does not require complex image recognition and processing, has a simple structure, and is suitable for extravasation detection in various injection scenarios, including high-pressure injection.

[0028] 2. The matrix stress sensing link provided by this invention innovatively combines the principle of matrix circuit with the separation or breakage design of three-dimensional spatial latitude and longitude nodes. It has high sensitivity and can calculate the volume of the bulge in the skin tension deformation area by accurately locating the position and number of separation points or break points, and then calculate the volume of extravasation fluid accumulation. This makes it convenient for medical staff to evaluate the treatment plan for abnormal extravasation and change the subsequent injection plan.

[0029] 3. The serpentine stress-sensing link technology provided by this invention is simple and low in cost; the three patch-type stress-sensing links provided by this invention are suitable for different precision requirements of extravasation detection scenarios and can cover a variety of precision requirements of injection scenarios.

[0030] 4. The sensing component and terminal component of this invention work together through wireless communication and are equipped with alarm management, which facilitates remote operation by medical staff. It is suitable for extravasation detection needs in long-term injection scenarios, remote injection scenarios, isolated injection scenarios, and home injection scenarios.

[0031] 5. The patch-type stress sensing link and signal processing transceiver separation design provided by this invention features a disposable patch that ensures medical and health safety and is suitable for industrial-scale production; the signal component is a reusable accessory that saves medical and natural resources. Attached Figure Description

[0032] Figure 1 This is an external view of the sensing component of an extravasation detection device based on a skin deformation sensor;

[0033] Figure 2 Exploded view of the sensing component;

[0034] Figure 3 This is an exploded view of the stress-inducing layer structure in Example 1;

[0035] Figure 4 This is a front view schematic diagram of the stress-sensing link structure in Example 1;

[0036] Figure 5 A schematic diagram of the stress-sensing layer structure in the initial state of Embodiment 1;

[0037] Figure 6 A detailed diagram of the connection structure at point A of the stress-sensing link in Example 1, in its initial state;

[0038] Figure 7 A detailed diagram of the connection structure at point B of the stress-sensing link in Example 1, in its initial state;

[0039] Figure 8 A schematic diagram of the stress-sensing layer structure in Example 1 under stress deformation state;

[0040] Figure 9 A detailed diagram of the connection structure at point A of the stress-sensing link in Example 1 under stress deformation state;

[0041] Figure 10 A detailed diagram of the connection structure at point B of the stress-sensing link in Example 1 under stress deformation state;

[0042] Figure 11 This is a schematic diagram of the stress-sensing layer structure in Example 2;

[0043] Figure 12 This is a front view schematic diagram of the stress-sensing link structure in Example 2;

[0044] Figure 13 Cross-sectional view of the connection structure at point C of the stress-sensing link in Embodiment 2 when the plane is in the state;

[0045] Figure 14 This is a cross-sectional view of the connection structure at point C of the stress-sensing link in Example 2, in its initial state.

[0046] Figure 15 Cross-sectional view of the connection structure at point C of the stress-sensing link in Example 2 under stress deformation state;

[0047] Figure 16 This is a schematic diagram of the stress-sensing layer structure in Example 3;

[0048] Figure 17 This is a front view schematic diagram of the stress-sensing link structure in Example 3;

[0049] Figure 18 A schematic diagram of the stress-sensing link structure in Example 3 under stress deformation state;

[0050] Figure 19 This is a schematic diagram of the working state of an extravasation detection device based on a skin deformation sensor.

[0051] In the diagram: 1. Sensing component; 2. Terminal component; 110. Exudation detection patch; 120. Signal component; 111. Stress sensing layer; 112. Insulation layer; 113. Adhesive layer; 114. Link interface; 115. Dustproof film; 1110. Retention layer; 1111. Uplink layer; 1112. Downlink layer; 1113. Contact; 1114. Baseline link; 1115. Breakpoint link; 1116. Deformation link. Detailed Implementation

[0052] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0053] Furthermore, elements in this invention are referred to as being "fixed to" or "set on" another element, which may be directly on the other element or may also include an intervening element. When an element is considered to be "connected" to another element, it may be directly connected to the other element or may also include an intervening element. The terms "vertical," "horizontal," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementations.

[0054] Please see Figures 1-19 The extravasation detection device based on a skin deformation sensor provided by this invention includes a sensing component 1 that is wirelessly connected to a terminal component 2. The terminal component 2 is a conventional computer terminal or mobile phone terminal. The terminal component 2 is loaded with a control program provided by this invention that matches the extravasation detection device and injection device based on the skin deformation sensor. This program receives signals transmitted wirelessly from the sensing component 1 and the injection device, performs necessary data processing, issues alarms, automatically terminates the injection procedure, or resumes the injection procedure after confirmation by medical personnel.

[0055] Specifically, such as Figures 1 to 2 As shown, the sensing component 1 includes an extravasation detection patch 110 and a signal component 120. The extravasation detection patch 110 contains a stress-sensing layer 111, and within the stress-sensing layer 111 is a stress-sensing link. This stress-sensing link converts changes in skin tension into changes in electromagnetic signals, which are then fed back as feedback. The extravasation detection patch 110 is made of a flexible material, making it easily deformable under external force. When the extravasation detection patch 110 is applied to the skin around the injection point, if extravasation occurs, the skin at the injection site will abnormally bulge, creating a bump. The skin tension at the bump changes relative to other normal skin areas, causing a corresponding deformation in the stress-sensing layer 111. This deformation enables the stress-sensing link within the patch to generate a corresponding feedback signal.

[0056] The signal component 120 is connected to the stress sensing link inside the patch 110 via the link interface 114 fixed on the patch 110. It receives and processes the feedback information from the stress sensing link in real time, monitors the changes in skin tension within the coverage area of ​​the patch 110, and thus achieves the purpose of detecting extravasation.

[0057] Furthermore, the extravasation detection patch 110 also includes an insulating layer 112 and an adhesive layer 113. The insulating layer 112 is made of a flexible insulating material, covering the upper part of the stress-sensing layer 111 and fixedly connected to the upper surface of the stress-sensing layer 111, serving an insulating function. The line interface at the lower end of the link interface 114 penetrates through the insulating layer 112 and extends into the interior of the stress-sensing layer 111, connecting to the sensing link inside the stress-sensing layer 111. The upper end of the link interface 114 is exposed outside the insulating layer 112 and is detachably connected to the bottom end of the signal component 120. The link interface 114 serves as a bus channel between the stress-sensing link and the signal component 120, and is provided with necessary insulation protection. The adhesive layer 113 is made of a flexible adhesive material, fixedly connected to the lower surface of the stress-sensing layer 111, and has strong adhesive properties. It is used to adhere to the skin around the injection point and deforms with skin tension.

[0058] Furthermore, the extravasation detection patch 110 is a disposable device. When not in use, the extravasation detection patch 110 is sealed in packaging, and a dustproof film 115 is provided under the adhesive layer 113. To use, simply peel off the dustproof film 115 and adhere the extravasation detection patch 110 to the target skin. After use, peel the extravasation detection patch 110 off the skin and discard it into a medical waste bin.

[0059] In this invention, the signal component 120 and the extravasation detection patch 110 are separate components. The signal component 120 internally houses a miniature power module, a signal processing module, a wireless communication module, and an alarm module for signal reception, preliminary data processing, signal transmission, and alarm sending. The signal component 120 is detachably connected to the link interface 114. Because the extravasation detection patch 110 isolates the skin during use, the signal component 120 can be removed from the patch after use and disinfected with anhydrous alcohol for reuse.

[0060] To better illustrate the inventive concept of this application, this invention provides three different stress-sensing links with specific structures for detailed explanation. Example 1

[0061] like Figures 3 to 10 As shown in Embodiment 1 of the present invention, the stress-sensing layer 111 has a multi-layer structure, which is divided into a retaining layer 1110, an uplink layer 1111, and a downlink layer 1112 from top to bottom. The upper surface of the retaining layer 1110 is fixedly connected to the lower surface of the insulating layer 112, the lower surface of the retaining layer 1110 is fixedly connected to the upper surface of the uplink layer 1111, the lower surface of the uplink layer 1111 is detachably connected to the upper surface of the downlink layer 1112, and the lower surface of the downlink layer 1112 is fixedly connected to the upper surface of the adhesive layer 113.

[0062] Specifically, the retaining layer 1110 is made entirely of a soft and insulating colloidal material. Inside the colloidal layer is a memory film capable of retaining deformation. This memory film is made of a material with a certain degree of rigidity and toughness, allowing it to deform under strong external force and maintain that deformation under weaker force. When the extravasation detection patch 110 is applied to the target skin, medical personnel press it firmly. The retaining layer 1110 is pressed from a flat state to its initial state of adhesion to the skin surface and maintains this initial state, without undergoing secondary deformation due to the slight tension of skin bulges. It should be noted that the memory film in the retaining layer only serves to remember the initial deformation; it provides insulation and isolation from the electrical pathways within the upstream link or link interface 114 and does not function as an electrical pathway. Therefore, the memory film can be made of metal to ensure good deformation retention characteristics.

[0063] The uplink layer 1111 and the downlink layer 1112 are both made of a soft and insulating gel material. Uplinks arranged in columns are located inside the gel of the uplink layer 1111, and downlinks arranged in rows are located inside the gel of the downlink layer 1112. The uplinks and downlinks are arranged in a checkerboard pattern with alternating rows and columns. Both the uplinks and downlinks are completely encased in a soft, insulating gel, with adjacent rows and columns insulated from each other. Contacts 1113 are only located at the intersection points for vertical connection. The uplinks, downlinks, and contacts 1113 together form a contact-based matrix sensing link.

[0064] The lower surface of the colloid in the upper link layer 1111 is separably connected to the upper surface of the colloid in the lower link layer 1112. Specifically, the link interface 114 sequentially fixes the colloid region penetrating the insulating layer 112, the protective layer 1110, and the upper link layer 1111, with the lower end of the link interface 114 fixedly connected to the colloid inside the lower link layer 1112. The colloids of the upper link layer 1111 and the lower link layer 1112 are kept in relative contact through the lower end of the link interface 114, and the contact surfaces do not rotate relative to each other in the horizontal direction. Figures 5 to 7 As shown, when medical staff apply the extravasation detection patch 110 to the target skin area and press the extravasation detection patch 110 firmly towards the skin, the upper link layer 1111 and the lower link layer 1112 deform synchronously, and all contacts 1113 remain tightly adhered.

[0065] When extravasation occurs, the skin tension forming the bulge causes the lower link layer 1112 to deform from the center of the bulge outwards and upwards. That is, the lower link layer 1112 expands outwards from the central area of ​​the bulge while simultaneously pushing upwards. At this time, because there is no pressure applied from above by medical personnel, the retaining layer 1110 maintains its initial deformation. The upper link layer 1111 and the lower link layer 1112 are no longer subjected to symmetrical forces and therefore can no longer maintain synchronous deformation, resulting in separation. Figure 8 As shown. The contact points 1113 in the area of ​​skin tension change begin to separate from the outside in, as... Figures 9 to 10 As shown.

[0066] Preferably, the upper and lower links are made of a uniform flexible conductive material, and the resistance of the material changes little under deformation stress. The contact surface diameter of contact 1113 is larger than the path diameter of the upper and lower links, that is, the contact surface resistance of contact 1113 is less than the unit path resistance of the checkerboard formed by the upper and lower links.

[0067] The specific working principle of a matrix circuit is as follows:

[0068] Let the unit path resistance between adjacent contacts 1113 be... If the total number of columns is N and the total number of rows is M, then the total resistance of each column is: Total resistance per row: Voltages are applied to the N columns of the uplink. Voltages are applied to the M-link of the downlink respectively. .

[0069] When all contacts 1113 are tightly closed, the total current in the i-th row is: ,in It is the sum of the current components formed by all column voltages in the i-th row; the total current in the j-th column: ,in It is the sum of the current components formed by each row voltage in the j-th column.

[0070] When contact 1113 in row i and column j separates, the total current in row i becomes ,in It is the sum of the current components formed by the voltages in each column after the separation point in the i-th row; at the same time, the total current in the j-th column becomes ,in It is the sum of the current components formed by the voltages in each column after the separation point on the i-th row.

[0071] By detecting the change in total current in each row and column and comparing it with the initial current base, the specific row and column number of the separation point can be calculated. The spacing between contacts 1113 is a known parameter. Using the spacing parameter between contacts 1113, the skin bulge arc surface of the deformation area can be calculated, and then the volume of the skin bulge and the volume of extravasated fluid can be calculated. Example 2

[0072] like Figures 11 to 15 As shown, in Embodiment 2 of the present invention, the stress sensing layer 111 is a single-layer structure. The stress sensing layer 111 is made of a soft and insulating colloidal material, and a baseline link 1114 and a breakpoint link 1115 are set inside it.

[0073] The baseline link 1114 is made of a uniform flexible conductive material, and the resistance change of this material under deformation stress is small; the break point link 1115 is made of a hard conductive material with a certain rigidity; for example, it is made of a conductive metal with good conductivity and hardness, so that the resistance value of the break point link 1115 per unit length is much smaller than the resistance value of the baseline link 1114 per unit length.

[0074] As Figure 12 shown, the baseline link 1114 is uniformly arranged in a "Ji" - shaped array by a conductive loop, and several rows of break point links 1115 are uniformly horizontally distributed along the longer vertical column of the baseline link 1114. As Figure 13 shown, break points are set on the break point link 1115, and adjacent break point links 1115 are connected end - to - end at the break points; the break points are located at the intersections of the break point link 1115 and the baseline link 1114. At the break points, one end of the break point link 1115 is fixedly connected to the baseline link 1114 at this intersection, and the other end of the break point link 1115 can be freely separated from the baseline link 1114 at this intersection. The baseline link 1114, the break point link 1115 and the break points together form a break - point type matrix induction link.

[0075] When the stress - sensing layer 111 is in a planar state as a whole, adjacent break point links 1115 are in contact and connected. As the stress - sensing layer 111 adheres to the target skin and produces an initial deformation, the adjacent break point links 1115 at the break points start to break and separate. As Figure 14 shown, because the break point link 1115 has a certain cross - sectional thickness, the separation distance between adjacent break point links 1115 is short in the initial state, and there is still some contact, so a conductive path can still be formed; as Figure 15 shown, when an exudate occurs and causes a bulging tension on the skin, the increased deformation of the stress - sensing layer 111 causes the break points to completely break and separate, and also be completely misaligned with the baseline link 1114 at the intersections, and this row of break point links 1115 is completely open - circuited.

[0076] It should be noted that the baseline link 1114 and the break point link 1115 are only electrically connected at the intersections. The part of the baseline link 1114 outside the part directly in contact with the break point link 1115 at the intersections is wrapped by an insulating colloid; the outer periphery of the break point link 1115 column is covered with an insulating film. Therefore, only at the cross - section of the break points is the circuit electrically connected between adjacent break point links 1115.

[0077] Referring to the working principle of the matrix - type circuit, let the resistance of the path per unit length on the baseline link 1114 be , a total of K rows of break point links 1115 are set, and the resistance value of the break point link 1115 can be ignored relative to the resistance value of the baseline link 1114. A baseline voltage is set at one end of the baseline link 1114, and voltages The formulas for calculating the current at each row and column breakpoint are similar to the principle formulas in Example 1, and will not be elaborated further here.

[0078] Based on the principle that current always chooses the path of least resistance in a path, when all breaks are not completely separated, the baseline current only passes through the first baseline and the last baseline column, and the baseline current and the current on each row of breakpoint links 1115 are at their maximum values. When skin bulges cause partial breakage, the baseline current detours around the baseline link 1114 and the current decreases, pointing towards the diagonal breakpoint in the area covered by the breakpoint. The current on the breakpoint link 1115 in the area defined by the diagonal breakpoint decreases or disappears. When all breaks are completely separated, the current on all rows of breakpoint links 1115 is 0, and the baseline current is at its minimum value. The area where the breakpoint is located can be calculated based on the changes in the current on the baseline link 1114 and the breakpoint link 1115. Then, the skin deformation arc surface and the volume of extravasated fluid can be calculated based on the breakpoint area and the unit spacing parameter. Example 3

[0079] like Figures 16 to 18 As shown, in Embodiment 3 of the present invention, the stress sensing layer 111 is a single-layer structure. The stress sensing layer 111 is made of a soft and insulating colloidal material and has a deformation link 1116 inside.

[0080] The deformation link 1116 is made of an electrically sensitive conductive material, the resistance of which changes significantly with stress deformation. At the same time, the deformation link 1116 consists of a conductive path arranged in a "W" shape, forming a serpentine chain-like induction link.

[0081] It should be noted that the overall external shape of the matrix-arranged sensing links can be square, circular, or other suitable shapes, but the rows and columns connected by the current need to be orthogonal, like latitude and longitude lines. The curved surface of the bulge is divided according to the division of latitude and longitude lines. The sensitivity of the sensing links to three-dimensional deformation can be determined based on the division of latitude and longitude lines, the threshold range of current changes with the natural physiological changes of the skin can be excluded, the location of separation points or breakpoints can be located, and then the specific volume of the bulge can be calculated.

[0082] In a serpentine chain-like arrangement, each branch of the induction link is arranged at a certain angle and is not orthogonal to the others. Figure 18 As shown, when extravasation causes skin bulges, changes in skin tension trigger significant three-dimensional deformation of the deformation link 1116, resulting in a noticeable change in current.

[0083] Currently, relatively mature electrical sensitive and conductive materials include, but are not limited to, carbon conductive ink, conductive polymers, metal nanowires or carbon nanotubes, etc. Different specifications of external leakage detection patches can be made by selecting the appropriate materials according to the actual application scenario and processing cost.

[0084] This invention also provides a method for detecting extravasation based on the above-mentioned extravasation detection device, comprising the following steps:

[0085] S1. Preparation: Align the center point of the extravasation detection patch 110 with the injection point and stick it tightly to the skin of the injection area. Install the sterilized signal component 120 on the link interface 114 of the extravasation detection patch 110 and turn on the signal switch to establish a wireless connection with the terminal component 2.

[0086] S2. Initialization: Start the injection control program on terminal component 2, record the stress sensing link current information fed back by signal component 120 before injection, and confirm the current change threshold range for starting and stopping the injection program.

[0087] S3. Start injection and manage the automated injection process: Signal component 120 provides real-time feedback of stress sensing link current information. The injection control program on terminal component 2 compares the real-time current information with the current information before injection and calculates the current change value in real time. When the current change value exceeds the threshold, the specific bulge volume is calculated, and alarm information is sent to signal component 120 and medical control console respectively. At the same time, the injection device is controlled to stop the injection.

[0088] S4. Medical staff check for abnormal alarms and handle them. After clearing the alarm, they confirm whether to continue the injection.

[0089] S5. Injection completed or terminated, process ends.

[0090] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0091] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. An extravasation detection device based on a skin deformation sensor, characterized in that, include: Sensing component (1) and terminal component (2); the sensing component (1) and the terminal component (2) work together via wireless communication. The sensing component (1) includes an extravasation detection patch (110) and a signal component (120). The extravasation detection patch (110) is provided with a stress sensing layer (111) inside, and a stress sensing link is provided inside the stress sensing layer (111). The stress sensing link converts changes in skin tension into changes in electromagnetic signals and outputs feedback. The extravasation detection patch (110) is provided with a link interface (114), and the link interface (114) serves as a bus channel connecting the stress sensing link and the signal component (120). The signal component (120) is detachably connected to the link interface (114); the signal component (120) is internally equipped with a miniature power module, a signal processing module, a wireless communication module and an alarm module, for signal reception, data processing, signal transmission and alarm sending; The terminal component (2) is a console device used for signal reception, data processing, alarm and injection program control; The external leakage detection patch (110) also includes an insulating layer (112), an adhesive layer (113), and a dustproof film (115). The stress sensing link is either a matrix-arranged sensing link or a serpentine chain-arranged sensing link; the rows and columns of the current-connected sensing link in the matrix-arranged sensing link are orthogonal; each branch of the serpentine chain-arranged sensing link is arranged at a certain angle and is not orthogonal to each other. The matrix-arranged sensing links include contact-type matrix sensing links and breakpoint-type matrix sensing links, and the serpentine chain-arranged sensing links include serpentine chain-type sensing links.

2. The extravasation detection device according to claim 1, characterized in that, The stress-sensing layer (111) has a multi-layer structure, which is divided into a retaining layer (1110), an uplink layer (1111), and a downlink layer (1112) from top to bottom. The retaining layer (1110) is provided with a memory sheet inside, and the memory sheet has a corresponding deformation retention function according to the degree of external force. The retaining layer (1110) is fixedly connected to the uplink layer (1111), and the uplink layer (1111) and the downlink layer (1112) can be detachably connected.

3. The extravasation detection device according to claim 2, characterized in that, The uplink layer (1111) is internally configured with uplinks, and the downlink layer (1112) is internally configured with downlinks. The uplinks and downlinks are arranged according to a row and column matrix, respectively. Adjacent uplinks are insulated from each other. Adjacent downlinks are insulated from each other. The uplinks and downlinks are insulated from each other on the row and column lines, and contact points (1113) are provided only at the intersection points for vertical connection. The uplinks, downlinks and contact points (1113) together form the contact-type matrix sensing link.

4. The extravasation detection device according to claim 1, characterized in that, The stress-sensing layer (111) is a single-layer structure, with a baseline link (1114) and a breakpoint link (1115) inside.

5. The extravasation detection device according to claim 4, characterized in that, The baseline link (1114) is uniformly arranged in a "zigzag" array by a conductive path, and several rows of the break links (1115) are uniformly horizontally distributed along the longitudinal column of the baseline link (1114); a break point is set at the intersection of the break link (1115) and the baseline link (1114), one end of the break link (1115) at the break point is fixedly connected to the baseline link (1114) at this intersection, and the other end of the break link (1115) can be freely separated from the baseline link (1114) at this intersection; the baseline link (1114), the break link (1115) and the break point together form the break-type matrix induction link.

6. The extravasation detection device according to claim 1, characterized in that, The stress induction layer (111) is a single-layer structure with a deformation link (1116) provided inside.

7. The extravasation detection device according to claim 6, characterized in that, The deformation link (1116) is made of an electro-sensitive conductive material and is arranged in a "W" shape by a conductive path, and the whole forms the snake-shaped chain induction link.

8. The extravasation detection method of the extravasation detection device according to claim 1, comprising the following steps: S1. Preparation work: Align the center point of the extravasation detection patch (110) with the injection point and closely attach it to the skin of the injection area, install the disinfected signal component (120) on the link interface (114) of the extravasation detection patch (110), turn on the signal switch, and establish a wireless connection with the terminal component (2); S2. Initialization: Start the injection control program on the terminal component (2), record the stress induction link current and voltage information fed back by the signal component (120) before injection, and confirm the current change threshold range for starting and aborting the injection program; S3. Start injection, automatic injection process management: The signal component (120) feeds back the stress induction link current information in real time, the injection control program on the terminal component (2) compares the real-time current information with the pre-injection current information, and calculates the current change value in real time. When the current change value exceeds the threshold, calculate the specific bulge volume, and send warning messages to the signal component (120) and the console device respectively, and at the same time control the injection device to abort the injection; S4. Medical staff check the abnormal warning and handle it, and confirm whether to continue injection after eliminating the warning; S5. Injection is completed or injection is terminated, and the process ends.

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