Exosmosis detection device based on skin deformation sensor

Abstract

The invention relates to the technical field of medical instruments, in particular to an extravasation detection device based on a skin deformation sensor, which comprises a sensing assembly and a terminal assembly, the sensing assembly and the terminal assembly cooperatively work in a wireless communication mode; the sensing assembly comprises an extravasation detection patch and a signal assembly; a stress sensing layer is arranged in the extravasation detection patch, a stress sensing link is arranged in the stress sensing layer, and the stress sensing link converts skin tension changes into changes of electromagnetic signals to be fed back and output. According to the extravasation detection device, the sensing assembly and the terminal assembly cooperatively work in a wireless communication mode, meanwhile, alarm management is set, remote operation of medical staff is facilitated, and the extravasation detection device is suitable for extravasation detection in various injection scenes.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of intravenous injection, in particular to an extravasation detection device based on a skin deformation sensor. BACKGROUND

[0002] During the intravenous injection process, extravasation events are inevitable, causing tissue damage, hematoma, infection and other complications. Especially when using a high-pressure injector, the injection process has a high flow rate and strong backwash, which can easily cause the needle to deviate, causing greater harm. Therefore, quickly detecting extravasation can promote timely medical intervention and prevent adverse events.

[0003] A Chinese patent with publication number CN115445025 discloses an injection liquid extravasation detection method, device and injection system. The injection liquid extravasation detection method includes: obtaining impedance information of a biological tissue; obtaining change information of the impedance information relative to a reference impedance value; and determining extravasation information of the injection liquid based on the change information. The injection liquid extravasation can be quickly detected, and the type and extravasation amount of the extravasation injection liquid can be determined. However, the scheme applies an excitation signal to the biological tissue through an excitation electrode; and calculates the impedance information by collecting the signal of the biological tissue after being stimulated by the excitation signal. During the high-pressure injection process, the patient's arm or back skin is subjected to a high liquid pressure impact. At this time, if an excitation signal is applied, the biological signal received by the measuring device is relatively mixed, which is not conducive to accurate biological impedance measurement.

[0004] A Chinese patent with publication number CN113230491B discloses a method and device for CT contrast agent extravasation detection using a camera and a pressure sensor. The device includes a wearable device with a miniature camera, a processor unit, a data transceiver unit, a housing and other components. Image data captured by the miniature camera is transmitted to a monitoring terminal, and medical personnel visually check the images to determine whether extravasation occurs. The scheme relies on the experience of medical personnel and is limited by image transmission accuracy, which is not conducive to early extravasation detection.

[0005] A Chinese patent with publication number CN216022453U discloses a method and device for contrast agent extravasation detection using an infrared sensor. The device uses a laser to scan the skin of the injection area in real time, and monitors the extravasation phenomenon according to the change in skin flatness. The device is complex, and there should be no obstruction between the laser scanning device and the skin of the injection area, which has high space requirements. SUMMARY

[0006] The present application aims to provide an extravasation detection device based on a skin deformation sensor to solve the problems raised in the background.

[0007] To achieve the above-mentioned purpose, the present application provides the following technical solutions:

[0008] The exosmosis detection device based on skin deformation sensor comprises an induction assembly and a terminal assembly; the induction assembly and the terminal assembly work cooperatively through wireless communication mode;

[0009] The induction assembly comprises an exosmosis detection patch and a signal assembly.

[0010] The exosmosis detection patch is internally provided with a stress induction layer, and the stress induction layer is internally provided with a stress induction link; the stress induction link converts the change of skin tension into the change of electromagnetic signal feedback output; the exosmosis detection patch is provided with a link interface, which serves as a bus channel connecting the stress induction link and the signal assembly.

[0011] The signal assembly is detachably connected with the link interface; the signal assembly is internally provided with a micro power module, a signal processing module, a wireless communication module and an alarm module for signal receiving, data processing, signal transmission and alarm sending.

[0012] The terminal assembly is a console device for signal receiving, data processing, alarm and injection program control.

[0013] Preferably, the exosmosis detection patch further comprises an insulating layer, a sticking layer and a dustproof film.

[0014] Preferably, the stress induction layer is a multilayer structure, which is divided into a holding layer, an upper link layer and a lower link layer from top to bottom; the holding layer is internally provided with a memory sheet, which has a corresponding deformation holding function according to the degree of external force action; the holding layer is fixedly connected with the upper link layer, and the upper link layer is detachably connected with the lower link layer.

[0015] Preferably, the upper link layer is internally provided with an upper link, and the lower link layer is internally provided with a lower link; the upper link and the lower link are arranged in a row-column matrix respectively; adjacent upper links are insulated; adjacent lower links are insulated; the upper link and the lower link are insulated on the row-column lines, and only a contact point for upper and lower adhesion is arranged at the intersection point; the upper link, the lower link and the contact point form a contact point type matrix induction link as a whole.

[0016] Preferably, the stress induction layer is a single-layer structure, which is internally provided with a baseline link and a breakpoint link.

[0017] Preferably, the baseline link is arranged in a "U" shape array with a conductive path, and a plurality of rows of the breakpoint links are evenly distributed transversely along the longitudinal direction of the baseline link; a breakpoint is arranged at the intersection of the breakpoint link and the baseline link, one end of the breakpoint link at the breakpoint is fixedly connected with the baseline link at the intersection, and the other end of the breakpoint link at the breakpoint is freely separable from the baseline link at the intersection; and the baseline link, the breakpoint link and the breakpoint integrally form a breakpoint matrix induction link.

[0018] Preferably, the stress sensing layer is a single-layer structure, and the deformed link is arranged inside.

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

[0020] An extravasation detection method of an extravasation detection device based on a skin deformation sensor, comprising the following steps:

[0021] S1, preparation: align the center point of the extravasation detection patch with the injection point and tightly attach the extravasation detection patch to the skin of the injection area, install the signal assembly after sterilization on the link interface of the extravasation detection patch, turn on the signal switch, and establish wireless connection with the terminal assembly;

[0022] S2, initialization: start the injection control program on the terminal assembly, record the stress sensing link current information fed back by the signal assembly before injection, and confirm the current change threshold range for stopping the injection program during startup;

[0023] S3, start injection and automatic injection process management: the signal assembly feeds back the stress sensing link current information in real time, the injection control program on the terminal assembly 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 value, the specific swelling volume is calculated, and alarm information is sent to the signal assembly and the medical staff control console respectively, and the injection device is controlled to stop injection;

[0024] S4, medical staff checks abnormal alarm and handles, confirms whether to continue injection after the alarm is eliminated;

[0025] S5, injection is completed or terminated, and the process is ended.

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

[0027] 1. The application provides a high feasibility stress sensing link idea of converting skin tension changes into electromagnetic signal change feedback output, and provides two structures of matrix stress sensing link and snake link stress sensing link. The scheme has small skin stimulation on the injection area, has low demand for detection space, does not need complex image recognition and processing process, has simple structure, and is suitable for various injection scene extravasation detection needs including high pressure injection;

[0028] 2. The matrix stress sensing link provided by the application is newly designed on the basis of matrix circuit principle and combined with three-dimensional space longitude and latitude node separation or breaking, has high sensitivity, can accurately position the separation point or breaking point position and quantity, calculate the skin tension deformation area bulge volume, and then calculate the extravasation liquid volume, so as to facilitate medical staff to evaluate extravasation abnormal treatment scheme and replace subsequent injection scheme;

[0029] 3. The snake link stress sensing link provided by the application has simple process and low cost; the three patch stress sensing links provided by the application are respectively suitable for extravasation detection scenes with different accuracy requirements, and can cover injection scenes with various accuracy requirements;

[0030] 4. The sensing assembly and the terminal assembly of the application work cooperatively through wireless communication mode, and an alarm management is arranged, so as to facilitate remote operation of medical staff, and is suitable for extravasation detection needs in long time injection scene, remote injection scene, isolation injection scene and home injection scene;

[0031] 5. The patch stress sensing link and signal processing transceiver separation design provided by the application, the patch is a disposable instrument, which ensures medical safety and is suitable for industrialized scale production; the signal assembly is a reusable matching device, which saves medical resources and natural resources. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 It is an appearance view of a sensing assembly of an extravasation detection device based on a skin deformation sensor;

[0033] Figure 2 It is an exploded view of the sensing assembly;

[0034] Figure 3 It is an exploded view of the stress sensing layer structure of embodiment one;

[0035] Figure 4 It is a front view structure schematic diagram of the stress sensing link of embodiment one;

[0036] Figure 5 It is a schematic diagram of the stress sensing layer structure of embodiment one in the initial state;

[0037] Figure 6 It is a detail view of the connection structure at A of the stress sensing link of embodiment one in the initial state;

[0038] Figure 7 Detail view of the connection structure at stress sensing link B in embodiment one in initial state;

[0039] Figure 8 Schematic diagram of the stress sensing layer structure in embodiment one in stress deformation state;

[0040] Figure 9 Detail view of the connection structure at stress sensing link A in embodiment one in stress deformation state;

[0041] Figure 10 Detail view of the connection structure at stress sensing link B in embodiment one in stress deformation state;

[0042] Figure 11 Schematic diagram of the stress sensing layer structure in embodiment two;

[0043] Figure 12 Schematic diagram of the stress sensing link in embodiment two;

[0044] Figure 13 Sectional view of the connection structure at stress sensing link C in embodiment two in flat state;

[0045] Figure 14 Sectional view of the connection structure at stress sensing link C in embodiment two in initial state;

[0046] Figure 15 Sectional view of the connection structure at stress sensing link C in embodiment two in stress deformation state;

[0047] Figure 16 Schematic diagram of the stress sensing layer structure in embodiment three;

[0048] Figure 17 Schematic diagram of the stress sensing link in embodiment three;

[0049] Figure 18 Schematic diagram of the stress sensing link structure in embodiment three in stress deformation state;

[0050] Figure 19 Working state schematic diagram of the extravasation detection device based on skin deformation sensor.

[0051] In the figure: 1, sensing component; 2, terminal component; 110, extravasation detection patch; 120, signal component; 111, stress sensing layer; 112, insulation layer; 113, adhesive layer; 114, link interface; 115, dustproof film; 1110, holding layer; 1111, upper link layer; 1112, lower link layer; 1113, contact; 1114, baseline link; 1115, breakpoint link; 1116, deformation link. DETAILED DESCRIPTION

[0052] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by a person of ordinary skill in the art without creative effort belong to the scope of protection of the present application.

[0053] In addition, elements in the present application are referred to as "fixed to" or "disposed on" another element, which can be directly on another element or can have a middle element. When an element is considered to be "connected" to another element, it can be directly connected to another element or can have a middle element. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only and do not represent the only implementation.

[0054] Please refer to Figures 1-19 The present application provides an extravasation detection device based on a skin deformation sensor, which includes a sensing assembly 1 connected to a terminal assembly 2 in a wireless transmission mode. The hardware of the terminal assembly 2 is a conventional computer terminal or a mobile phone terminal, and the terminal assembly 2 is loaded with a control program matching the extravasation detection device based on the skin deformation sensor and the injection device, which is used to receive signals transmitted by the sensing assembly 1 and the injection device in a wireless connection mode, perform necessary data processing, issue an alarm, automatically stop the injection program, or resume the injection program after confirmation by medical personnel, etc.

[0055] Specifically, as shown in Figures 1-2 The sensing assembly 1 includes an extravasation detection patch 110 and a signal assembly 120. The extravasation detection patch 110 is internally provided with a stress sensing layer 111, and the stress sensing layer 111 is internally provided with a stress sensing link. The stress sensing link converts the change of skin tension into the change of electromagnetic signal feedback output. The extravasation detection patch 110 is made of flexible material as a whole, and is easy to deform under external force. When the extravasation detection patch 110 is attached to the skin around the injection point, once extravasation occurs, the skin at the injection site will abnormally bulge and form a bump. The skin tension at the bump changes relative to the normal skin in other areas, causing the stress sensing layer 111 to deform accordingly. The deformation causes the stress sensing link inside it to generate a corresponding feedback signal.

[0056] The signal assembly 120 is connected to the stress sensing link inside the extravasation detection patch 110 through the link interface 114 fixed on the extravasation detection patch 110, and real-time receives and processes the feedback information of the stress sensing link, monitors the change of skin tension in the range covered by the extravasation detection patch 110, and thus achieves the purpose of extravasation detection.

[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.

[0061] Example 1:

[0062] like Figures 3-10 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.

[0063] Specifically, the holding layer 1110 is made of soft and insulating gel material as a whole, and a memory sheet with holding deformation ability is arranged inside the gel. The memory sheet is made of material with certain rigidity and toughness, which can produce corresponding deformation when subjected to strong external force, and maintain the deformation when the external force is small. When the exudation detection sticker 110 is pasted on the target skin, the medical staff presses the exudation detection sticker 110 with force, and the holding layer 1110 is pressed from the flat state to the initial state of adhesion with the skin surface, and always maintains the initial state and does not produce secondary deformation with the weak tension of the skin bulge. It should be noted that the memory sheet in the holding layer only plays the role of remembering the initial deformation, and is insulated from the electrical path inside the uplink or link interface 114, and has no effect on the electrical path. Therefore, the material of the memory sheet can be metal material to ensure its good deformation holding characteristics.

[0064] The uplink layer 1111 and the downlink layer 1112 are made of soft and insulating gel material as a whole. The uplink layer 1111 is arranged with uplink arranged in columns inside the gel, and the downlink layer 1112 is arranged with downlink arranged in rows inside the gel. The uplink and downlink are staggered in a chessboard shape, and are wrapped by soft and insulating gel. Adjacent rows and columns are insulated from each other, and only the contacts 1113 at the staggered points are connected upward and downward. The uplink, downlink and contacts 1113 form a contact matrix sensing link as a whole.

[0065] The lower surface of the gel of the uplink layer 1111 is detachably connected with the upper surface of the gel of the downlink layer 1112. Specifically, the link interface 114 is fixed through the insulating layer 112, the protection layer 1110 and the gel region of the uplink layer 1111 in sequence, and the lower end of the link interface 114 is fixedly connected with the gel inside the downlink layer 1112. The gels of the uplink layer 1111 and the downlink layer 1112 are kept relative adhesion by the lower end of the link interface 114, and the adhesion surface does not rotate relative in the horizontal direction. As shown in Figures 5-7 When the medical staff pastes the exudation detection sticker 110 on the target skin area and presses the exudation detection sticker 110 towards the skin with force, the uplink layer 1111 and the downlink layer 1112 keep synchronous deformation, and all the contacts 1113 keep close adhesion.

[0066] When exudation occurs, the skin tension formed by the bulge deforms the downlink layer 1112 from the center of the bulge to the periphery and upward, that is, the downlink layer 1112 expands from the center area of the bulge to the periphery and pops up upward. At this time, because there is no pressing force applied from above by the medical staff, the holding layer 1110 maintains the initial deformation, and the uplink layer 1111 and the downlink layer 1112 are no longer symmetrically stressed, so they cannot keep synchronous deformation and are separated, as shown in Figure 8The contact 1113 of the skin tension change area starts to separate from outside to inside, as shown in Fig. 11B. Figures 9-10

[0067] Preferably, the uplink and downlink are made of uniform flexible conductive material, and the material has small resistance change under deformation stress, the contact surface diameter of the contact 1113 is larger than the passage diameter of the uplink and downlink, that is, the contact surface resistance of the contact 1113 is smaller than the unit passage resistance of the chessboard composed of the uplink and downlink.

[0068] The specific working principle of the matrix circuit is as follows:

[0069] Suppose the unit passage resistance between adjacent contacts 1113 is ,

[0070] The total number of columns is N, and the total number of rows is M, then the total resistance of each column is: ;

[0071] The total resistance of each row is: .

[0072] The voltage ,

[0073] is respectively applied to the N column links of the uplink, and the voltage is respectively applied to the M row links of the downlink.

[0075] When all the contacts 1113 are closely attached, the total current of the i-th row is:

[0076] wherein

[0077] is the current component sum of all column voltages on the i-th row; and the total current of the j-th column is:

[0078] wherein

[0079] is the current component sum of all row voltages on the j-th column.

[0080] When the contact 1113 of the i-th row and the j-th column is separated, the total current of the i-th row becomes

[0081] wherein

[0082] is the current component sum of all column voltages on the i-th row after separation; and the total current of the j-th column becomes

[0083] wherein ​

[0084] is the current component formed by the voltage of each column on the ith row after the separation point.

[0085] By detecting the change of the total current of each row and each column and comparing it with the initial state of the current base, the specific row and column sequence number of the separation point can be calculated. The distance between the contacts 1113 is a known parameter, and the skin bulge arc surface of the deformation area can be calculated by the contact 1113 distance parameter, and then the skin bulge volume and the exudate volume can be calculated.

[0086] Example two:

[0087] As shown in the embodiment two provided by the present application, the stress sensing layer 111 is a single layer structure, and the stress sensing layer 111 is made of a soft and insulating colloid material as a whole, and the baseline link 1114 and the breakpoint link 1115 are arranged inside. Figures 11-15 The baseline link 1114 is made of a uniform flexible conductive material, and the resistance of the material changes little under deformation stress; the breakpoint link 1115 is made of a hard conductive material with a certain rigidity; for example, a conductive metal with good conductivity and hardness is used, so that the resistance value of the breakpoint link 1115 per unit length is much smaller than the resistance value of the baseline link 1114 per unit length.

[0088] As shown in the embodiment two provided by the present application, the stress sensing layer 111 is a single layer structure, and the stress sensing layer 111 is made of a soft and insulating colloid material as a whole, and the baseline link 1114 and the breakpoint link 1115 are arranged inside.

[0089] Figure 12 As shown in the embodiment two provided by the present application, the stress sensing layer 111 is a single layer structure, and the stress sensing layer 111 is made of a soft and insulating colloid material as a whole, and the baseline link 1114 and the breakpoint link 1115 are arranged inside. Figure 13 As shown in the embodiment two provided by the present application, the stress sensing layer 111 is a single layer structure, and the stress sensing layer 111 is made of a soft and insulating colloid material as a whole, and the baseline link 1114 and the breakpoint link 1115 are arranged inside.

[0090] When the stress sensing layer 111 as a whole is in a flat state, the adjacent breakpoint links 1115 are connected. When the stress sensing layer 111 is initially deformed by being attached to the target skin, the adjacent breakpoint links 1115 at the breakpoint begin to break and separate. As shown in the embodiment two provided by the present application, the stress sensing layer 111 is a single layer structure, and the stress sensing layer 111 is made of a soft and insulating colloid material as a whole, and the baseline link 1114 and the breakpoint link 1115 are arranged inside. Figure 14 Figure 15 ​​As shown, when the skin bulges due to extravasation, the deformation of the stress sensing layer 111 increases, causing the break point to completely break and separate, and the baseline link 1114 at the intersection is also completely misaligned, and the row break point link 1115 is completely disconnected.

[0091] It should be noted that the baseline link 1114 and the break point link 1115 are only electrically connected at the intersection, and the baseline link 1114 is wrapped in insulating glue outside the part directly contacting the break point link 1115 at the intersection; the break point link 1115 is covered with an insulating film on the outer periphery of the column, so that the adjacent break point links 1115 are only electrically connected at the cross section of the break point.

[0092] Referring to the working principle of the matrix circuit, the resistance per unit length of the baseline link 1114 is

[0093] K rows of break point links 1115 are provided, and the resistance of the break point link 1115 can be ignored relative to the resistance of the baseline link 1114. A baseline voltage is provided at one end of the baseline link 1114

[0094] A voltage is applied at one end of each row of break point links 1115

[0095] The current calculation formula at each row and column break point is similar to the principle formula in Example One, which will not be described in detail here.

[0096] According to the principle that the current always chooses the path with the smallest resistance in the circuit, when all break points are not completely separated, the baseline current only passes through the first baseline and the end baseline column, and the baseline current and the current on each row of break point links 1115 are maximum; when the skin bulges and causes some break points to break, the baseline current is diverted on the baseline link 1114 and the current becomes smaller, and the diagonal break point pointing to the covered area of the break point; the current of the break point link 1115 in the area defined by the diagonal break point decreases or disappears; when all break points are completely separated, the current of all rows of break point links 1115 is 0, and the baseline current is the minimum; the area of the break point can be calculated according to the change of the current on the baseline link 1114 and the break point link 1115, and then the skin deformation surface and the volume of the extravasated fluid can be calculated according to the break point area and the unit spacing parameters.

[0097] Example Three

[0098] As shown in Figures 16-18 , in Example Three provided by the present application, the stress sensing layer 111 is a single-layer structure, the stress sensing layer 111 is made of soft and insulating glue material as a whole, and a deformation link 1116 is provided inside.

[0099] The deformation link 1116 is made of an electrically sensitive conductive material, which has a relatively obvious change in resistance value with stress deformation.

[0100] It should be noted that the overall shape of the matrix arrangement of the induction link can be square, circular or other suitable shape, but the current communication row and column lines need to be orthogonal, like meridians and parallels, which divide the bulging curved surface, and the sensitivity of the induction link to three-dimensional deformation can be determined according to the division of meridians and parallels, the threshold range of the current change with the natural physiological change of the skin is excluded, the position of the separation point or the breakpoint is located, and then the specific bulging volume is calculated.

[0101] The induction link arranged in a snake chain type has each branch link arranged at a certain angle, and is not orthogonal to each other. Figure 18 As shown in the figure, when extravasation causes the skin to bulge, the skin tension change causes the overall deformation link 1116 to produce obvious three-dimensional deformation, causing the current to change significantly.

[0102] The relatively mature electrically sensitive conductive materials include but are not limited to carbon conductive ink, conductive polymer, metal nanowire or carbon nanotube, etc., and different specifications of the extravasation detection patch 110 can be made according to the actual use scene and processing cost.

[0103] The application also provides an extravasation detection method based on the above-mentioned extravasation detection device, which comprises the following steps:

[0104] S1, preparation: align the center point of the extravasation detection patch 110 with the injection point and tightly attach it to the skin of the injection area, install the signal assembly 120 after sterilization on the link interface 114 of the extravasation detection patch 110, turn on the signal switch, and make it establish wireless connection with the terminal assembly 2;

[0105] S2, initialization: start the injection control program on the terminal assembly 2, record the stress sensing link current information fed back by the signal assembly 120 before injection, and confirm the current change threshold range for stopping the injection program during startup;

[0106] S3, start injection, automatic injection process management: the signal assembly 120 feeds back the stress sensing link current information in real time, the injection control program on the terminal assembly 2 compares the real-time current information with the current information before injection, and calculates the current change value in real time, calculates the specific bulging volume when the current change value exceeds the threshold, and sends alarm information to the signal assembly 120 and the medical control console respectively, and controls the injection device to stop injection at the same time;

[0107] S4, medical personnel check abnormal alarm and handle, confirm whether to continue injection after eliminating the alarm;

[0108] S5, injection is completed or terminated, the process is ended.

[0109] It will be apparent to those skilled in the art that the application is not limited to the details of the above-exemplified embodiments, and that the application can be implemented in other particular forms without departing from the spirit or essential characteristics of the application. The embodiments should therefore be considered in all respects as illustrative and not restrictive, the scope of the application being indicated by the appended claims rather than by the above description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. No reference signs in the claims should be considered as limiting the scope of the claims to the features to which the reference signs are attached.

[0110] Furthermore, it should be understood that although the description is made on embodiments, not every embodiment contains only one independent technical solution, and the description is made in this way only for the sake of clarity, and those skilled in the art should consider the description as a whole, and the technical solutions in each embodiment can also be combined appropriately to form other embodiments which 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.

2. The extravasation detection apparatus according to claim 1, characterized by The external leakage detection patch (110) also includes an insulating layer (112), an adhesive layer (113), and a dustproof film (115).

3. The extravasation detection apparatus of claim 2, wherein 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.

4. The extravasation detection apparatus of claim 3, wherein 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. 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. Contacts (1113) are provided only at the intersection points for vertical connection. The uplinks, downlinks and contact points (1113) together form a contact-type matrix sensing link.

5. The extravasation detection apparatus of claim 2, wherein The stress-sensing layer (111) is a single-layer structure, with a baseline link (1114) and a breakpoint link (1115) inside.

6. The extravasation detection apparatus of claim 5, wherein The baseline link (1114) is uniformly arranged in a "U" shape by a conductive path, and a plurality of rows of breakpoint links (1115) are uniformly distributed transversely along the longitudinal direction of the baseline link (1114); a breakpoint is arranged at the intersection of the breakpoint link (1115) and the baseline link (1114), one end of the breakpoint link (1115) at the breakpoint is fixedly connected with the baseline link (1114) at the intersection, and the other end of the breakpoint link (1115) at the breakpoint is freely separable from the baseline link (1114) at the intersection; the baseline link (1114), the breakpoint link (1115) and the breakpoint form a breakpoint matrix induction link as a whole.

7. The extravasation detection apparatus of claim 2, wherein The stress sensing layer (111) is a single-layer structure, and a deformation link (1116) is arranged inside.

8. The extravasation detection apparatus of claim 7, wherein The deformation link (1116) is made of an electrically sensitive conductive material and arranged in a "W" shape by a conductive path.

9. The extravasation detection method of the extravasation detection device according to claim 1, comprising the following steps: S1, preparation: align the center point of the extravasation detection patch (110) with the injection point and tightly attach it to the skin of the injection area, install the sterilized signal assembly (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 assembly (2); S2, initialization: start the injection control program on the terminal assembly (2), record the stress sensing link current and voltage information fed back by the signal assembly (120) before injection, and confirm the current change threshold range for stopping the injection program during startup; S3, start injection and automatic injection process management: the signal assembly (120) feeds back the stress sensing link current information in real time, the injection control program on the terminal assembly (2) compares the real-time current information with the current information before injection, and calculates the current change value in real time, calculates the specific swelling volume when the current change value exceeds the threshold value, and sends alarm information to the signal assembly (120) and the medical staff control console respectively, and controls the injection device to stop injection at the same time; S4, medical staff checks abnormal alarm and handles, confirms whether to continue injection after eliminating the alarm; S5, injection is completed or terminated, and the process is ended.

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