Wound monitoring device

Abstract

This application discloses a wound monitoring device, relating to the field of medical device technology. The wound monitoring device includes a carrier, a strain sensor array, and a signal processing module. A flexible substrate is disposed on one side of the carrier, capable of covering and conforming to the target area where the wound of the target object is located, and capable of flexible deformation according to the shape changes of the target object within the target area. The strain sensor array is integrated on the flexible substrate and is used to convert the flexible deformation of the flexible substrate into electrical signals. The signal processing module is electrically connected to the strain sensor array and is used to obtain deformation information based on the electrical signals, compare the deformation information with a preset threshold, and output an alarm signal based on the comparison result. Through the application of this application, the problems of current clinical wound monitoring failing to reflect the overall tension change state of the wound area, providing one-sided and inaccurate monitoring results, failing to provide objective, continuous, and accurate assessment and early warning of the wound, and easily delaying medical care and rehabilitation are addressed.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more particularly to a wound monitoring device. Background Technology

[0002] In the clinical wound care and rehabilitation process, real-time monitoring of wound condition is crucial for avoiding complications and improving rehabilitation efficiency.

[0003] Current clinical wound monitoring relies heavily on manual observation or measurement using rigid single-point sensors, which makes it difficult to reflect the overall tension changes in the wound area. The monitoring results are one-sided and inaccurate, failing to provide objective, continuous, and precise assessment and early warning of the wound, and easily delaying medical care and rehabilitation.

[0004] Therefore, the above problems urgently need to be solved. Summary of the Invention

[0005] The purpose of this application is to provide a wound monitoring device to address the current clinical wound monitoring methods that rely heavily on manual observation or use rigid single-point sensors for measurement. These methods fail to reflect the overall tension changes in the wound area, resulting in biased and inaccurate monitoring results. Consequently, they cannot provide objective, continuous, and accurate assessments and early warnings of the wound, which can easily delay medical care and rehabilitation.

[0006] To address the aforementioned technical problems, this application provides the following technical solutions: This application provides a wound monitoring device for a target object, comprising: The carrier has a flexible base on one side. The flexible base can cover and conform to the target area where the wound of the target object is located, and can flexibly deform with the shape changes of the target object in the target area. A strain sensor array, integrated on a flexible substrate, is used to convert the flexible deformation of the flexible substrate into electrical signals; The signal processing module is electrically connected to the strain sensor array. It is used to obtain deformation information based on the electrical signal, compare the deformation information with a preset threshold, and output an alarm signal based on the comparison result.

[0007] In some embodiments, the aforementioned wound monitoring device has a protective encapsulation layer on the side of the carrier opposite to the flexible substrate; the signal processing module includes a flexible circuit layer, which is stacked between the flexible substrate and the protective encapsulation layer; the flexible circuit layer is electrically connected to a strain sensor array integrated on the flexible substrate.

[0008] In some embodiments, the aforementioned wound monitoring device includes a strain sensor array embedded within a flexible substrate; or, the strain sensor array is attached to the side of the flexible substrate facing the flexible circuit layer.

[0009] In some embodiments, the aforementioned wound monitoring device includes a signal processing module for acquiring electrical signals from each sensing unit in the strain sensor array to obtain deformation information including the average strain value of the target area; preset thresholds include a first threshold and a second threshold, and alarm signals include a first-level alarm signal and a second-level alarm signal; when the increase in strain value of the average strain value exceeds the first threshold within a first preset time, a first-level alarm signal is output; when the average strain value continues to exceed the second threshold within a second preset time, a second-level alarm signal is output.

[0010] In some embodiments, the aforementioned wound monitoring device further includes: an alarm, which is electrically connected to the signal processing module; the alarm is configured to: output a first alarm prompt when a first-level alarm signal is received, and output a second alarm prompt different from the first alarm prompt when a second-level alarm signal is received.

[0011] In some embodiments, the aforementioned wound monitoring device further includes a signal processing module for acquiring deformation information, including the spatial distribution characteristics of strain in the target area, based on the electrical signals of each sensing unit in the strain sensor array; when the spatial distribution characteristics of strain are discrete, the signal processing module does not output an alarm signal; when the spatial distribution characteristics of strain are continuous, the signal processing module makes an alarm judgment based on the average strain value.

[0012] In some embodiments, the aforementioned wound monitoring device further includes a signal processing module for acquiring deformation information including the strain change state of the target area based on the electrical signals of each sensing unit in the strain sensor array; the preset threshold also includes a time threshold; when the duration of the strain change state is less than the time threshold, the signal processing module does not output an alarm signal; when the duration of the strain change state is greater than or equal to the time threshold, the signal processing module makes an alarm judgment based on the average strain value.

[0013] In some embodiments, the aforementioned wound monitoring device further includes a third threshold in the preset threshold; the signal processing module is also used to acquire the real-time strain value of each sensing unit in the target area; when the absolute value of the difference between the real-time strain value of a certain sensing unit and the average strain value at the corresponding time exceeds the third threshold within a third preset time, the signal processing module can determine that the corresponding sensing unit has failed, and remove the electrical signal of the failed sensing unit when acquiring the electrical signal, and obtain the updated average strain value by acquiring the electrical signals of the remaining sensing units in the target area.

[0014] In some embodiments, the aforementioned wound monitoring device includes a carrier in the form of a strip, the strip having a first connecting end and a second connecting end, the first connecting end and the second connecting end being detachably connected; wherein, when the first connecting end and the second connecting end are connected, the carrier is annular.

[0015] In some embodiments, the aforementioned wound monitoring device further includes: an interaction module electrically connected to the signal processing module, the interaction module having a preset model; the interaction module is capable of inputting parameter information and adjusting the preset model according to the parameter information, so as to set the preset threshold of the signal processing module through the preset model.

[0016] By employing the above technical solution, the wound monitoring device of this application has at least the following advantages: This application provides a wound monitoring device for a target object, comprising a carrier, a strain sensor array, and a signal processing module. A flexible substrate is disposed on one side of the carrier, which covers and conforms to the target area where the wound is located, and can flexibly deform in response to changes in the shape of the target object within the target area. The strain sensor array is integrated on the flexible substrate and is used to convert the flexible deformation of the flexible substrate into electrical signals. The signal processing module is electrically connected to the strain sensor array and is used to obtain deformation information based on the electrical signals, compare the deformation information with a preset threshold, and output an alarm signal based on the comparison result. This application, through the conforming and responsive deformation design of the flexible substrate on one side of the carrier, can closely cover and conform to the target area where the wound is located, and flexibly deform synchronously with changes in the shape of the target area, accurately capturing tension changes in the wound and surrounding tissues within the target area, providing a reliable physical signal basis for monitoring. An integrated strain sensor array on a flexible substrate can acquire overall, global deformation information of the wound and surrounding tissues, accurately reproducing the overall tension change trend of the wound area. It can directly convert the synchronous deformation transmitted by the flexible substrate into electrical signals reflecting the tension changes of the target area wound and surrounding tissues, completing the digital conversion of tension changes into electrical signals and enabling continuous real-time monitoring of tension changes. Furthermore, this application, by setting a signal processing module electrically connected to the strain sensor array, can accurately obtain strain information based on the electrical signals. By comparing the strain information with preset thresholds, it achieves automated early warning judgment and alarm signal output, replacing subjective human judgment, eliminating human experience errors, and accurately identifying wound complications through early abnormal changes reflected by strain information, thus gaining golden time for clinical intervention. This application has strong clinical applicability. Through the application of this application, it solves the problem that current clinical wound monitoring relies heavily on manual observation or the use of rigid single-point sensors, which is difficult to reflect the overall tension change state of the wound area. The monitoring results are one-sided and inaccurate, failing to provide objective, continuous, and accurate assessment and early warning of the wound, easily delaying medical care and rehabilitation.

[0017] The above description is only an overview of the technical solution of this application. In order to better understand the technical means of this application and to implement it in accordance with the contents of the specification, the preferred embodiments of this application are described in detail below with reference to the accompanying drawings. Attached Figure Description

[0018] The above and other objects, features, and advantages of exemplary embodiments of this application will become readily understood by reading the following detailed description with reference to the accompanying drawings. In the drawings, several embodiments of this application are illustrated by way of example and not limitation, with the same or corresponding reference numerals denoteing the same or corresponding parts, wherein: Figure 1 The diagram illustrates a perspective isometric view of the wound monitoring device of the present invention when worn on a target object. Figure 2 The diagram schematically illustrates the solid isometric structure of a wound monitoring device of the present invention when worn on a target object; Figure 3 The schematic diagram illustrates the structure of a wound monitoring device of the present invention, comprising a flexible substrate, a strain sensor array, a flexible circuit layer, and a protective encapsulation layer disposed on a carrier. Figure 4 The diagram illustrates the structure of a strip-shaped carrier having a first connecting end and a second connecting end in accordance with the present invention for a wound monitoring device.

[0019] Explanation of icon numbers: 1. Carrier; 11. Flexible substrate; 12. Encapsulation and protective layer; 13. First connecting end; 14. Second connecting end; 2. Strain sensor array; 3. Flexible circuit layer; 4. Alarm device; 5. Target audience. Detailed Implementation

[0020] The embodiments of this application will be further described in detail below with reference to the accompanying drawings and examples. The detailed description of the following embodiments and the accompanying drawings are used to illustrate the principles of this application by way of example, but should not be used to limit the scope of this application. This application can be implemented in many different forms and is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

[0021] It should be noted that, in the description of this application, unless otherwise stated, "a plurality of" means two or more; the terms "upper," "lower," "left," "right," "inner," and "outer," etc., indicating orientation or positional relationship, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. When the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0022] Furthermore, the terms "first," "second," and similar terms used in this application do not indicate any order, quantity, or importance, but are merely used to distinguish different parts. "Vertical" is not strictly vertical, but within the permissible margin of error. "Parallel" is not strictly parallel, but within the permissible margin of error. Terms such as "including" or "contains" mean that the element preceding the word encompasses the element listed after it, and do not exclude the possibility of encompassing other elements as well.

[0023] It should also be noted that, in the description of this application, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this application depending on the specific circumstances. All terms used in this application have the same meaning as understood by those skilled in the art to which this application pertains, unless otherwise specifically defined. It should also be understood that terms defined in general dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant art, and should not be interpreted with an idealized or highly formalized meaning, unless expressly defined herein.

[0024] Techniques, methods, and equipment known to those skilled in the art may not be discussed in detail, but where appropriate, they should be considered part of the specification.

[0025] In the clinical wound care and rehabilitation process, real-time monitoring of wound condition is crucial for avoiding complications and improving rehabilitation efficiency.

[0026] Postoperative wound bleeding and subcutaneous emphysema are common and serious complications after neck surgeries such as thyroid surgery, neck lymph node dissection, and laryngeal surgery. Rapid accumulation of hematoma can compress the trachea, blood vessels, or nerves, leading to respiratory distress or even suffocation, endangering life. Subcutaneous emphysema may indicate deep tissue damage or infection. Currently, clinical monitoring of postoperative wound complications mainly relies on intermittent, subjective observation by healthcare professionals and patient complaints, including: visual observation (checking for dressing bleeding and the degree of swelling around the wound); palpation (feeling the tension and firmness of the tissue around the wound to assess for fluctuation); and patient inquiry (asking about symptoms such as swelling, tightness, increased pain, or difficulty breathing). These traditional methods have significant drawbacks: They are delayed in detection, only being discovered when complications have grown to a certain size, causing significant changes in appearance or obvious symptoms, missing the golden time for early intervention; they are subjective, relying on the experience and conscientiousness of healthcare professionals, with monitoring blind spots at night or during rounds; and they cannot be quantified, failing to provide objective, continuous pressure or tension data for accurate assessment and early warning.

[0027] In existing technologies, although some studies have attempted to place pressure sensors under bandages for monitoring, most of these sensors are rigid single-point designs that cannot conform to the flexible skin and dynamic tissues of the neck. They are prone to generating false signals due to physiological activities such as patients turning over, coughing, or friction from clothing. Furthermore, they can only capture local single-point pressure and cannot obtain the strain distribution characteristics of the wound area, resulting in poor practicality.

[0028] The inventors discovered that current clinical wound monitoring relies heavily on manual observation or measurement using rigid single-point sensors, which makes it difficult to reflect the overall tension changes in the wound area. The monitoring results are one-sided and lack accuracy, failing to provide objective, continuous, and precise assessment and early warning of the wound, and easily delaying medical care and rehabilitation. Therefore, a wound monitoring device was designed to solve the above problems.

[0029] like Figure 1 , Figure 2 As shown, this application provides a wound monitoring device for a target object 5, including a carrier 1, a strain sensor array 2, and a signal processing module; a flexible substrate 11 is provided on one side of the carrier 1, the flexible substrate 11 can cover and fit the target area where the wound of the target object 5 is located, and can undergo flexible deformation with the shape change of the target object 5 in the target area; the strain sensor array 2 is integrated on the flexible substrate 11, and is used to convert the flexible deformation of the flexible substrate 11 into an electrical signal; the signal processing module is electrically connected to the strain sensor array 2, and is used to obtain deformation information according to the electrical signal, compare the deformation information with a preset threshold, and output an alarm signal according to the comparison result.

[0030] Specifically, the wound monitoring device provided in this application is used for target object 5, which is a patient who needs postoperative wound monitoring or trauma care. It can be used for people with surgical incisions, traumatic wounds, postoperative bleeding risks or swelling risks in the neck, limbs and other parts, including patients who need continuous monitoring of wound status after neck surgery.

[0031] The wound monitoring device of this application includes a carrier 1, on one side of which is a flexible substrate 11. The flexible substrate 11 can cover and conform to the target area where the wound of the target object 5 is located, and can flexibly deform according to the shape changes of the target object 5 within the target area. The target area where the wound of the target object 5 is located refers to the area on the body of the target object 5 that includes the wound itself and the tissue within a predetermined range around the wound. This area covers not only the location of the wound, but also the extended area around the wound that may undergo tissue deformation due to swelling, bleeding, or hematoma formation. In one embodiment, the target area is the neck area of ​​the target object 5, but it can also be extended to other body parts such as limbs that can be monitored by the device by wrapping around them, depending on the actual monitoring needs. In this application, the carrier 1 of the wound monitoring device is used to provide structural support for the entire wound monitoring device. It can adopt a flexible support sheet, an elastic base membrane, a polymer flexible substrate, or a composite flexible support layer, etc., with a soft overall texture, making it easy to attach to the surface of the patient's limb or torso.

[0032] A flexible substrate 11 is disposed on the side of the carrier 1 facing the wound. The flexible substrate 11 can be made of polyurethane film, ultra-thin breathable medical-grade silicone film, etc., and has good extensibility and conformability, which can completely cover the target area where the wound is located and fit tightly to the skin surface. When the patient moves his / her limbs, changes his / her position, or the wound area swells, the flexible substrate 11 can follow the morphological changes of the tissue and deform synchronously, so that the sensor always maintains the same state as the skin deformation, accurately captures the tension changes of the wound and surrounding tissues in the target area, provides a real and reliable physical signal basis for monitoring, and avoids the monitoring signal distortion caused by rigid structure.

[0033] The strain sensor array 2 is integrated on the flexible substrate 11. This array consists of multiple strain sensing units arranged in a distributed or gridded manner. The sensing units can be resistive strain gauges, flexible capacitive sensors, piezoelectric sensing units, or flexible piezoresistive sensing units, etc. The sensing units are uniformly distributed on the flexible substrate 11, which can directly convert the synchronous mechanical deformation of the flexible substrate 11 caused by the deformation of wound tissue in the target area into electrical signals that reflect the tension changes of the wound and surrounding tissue with high fidelity. This achieves accurate digital conversion from mechanical deformation to electrical signals, thereby enabling continuous, real-time, and highly sensitive monitoring of tension changes in the target area.

[0034] Compared to single-point detection structures, the array-based arrangement of this application has significant technical advantages: First, it can comprehensively cover the target area where the wound is located, acquiring overall, global deformation information of the wound and surrounding tissues, rather than only reflecting partial data from a single local point, thus truly restoring the overall tension change trend of the wound area; Second, the distributed array structure provides a complete and reliable data foundation for subsequent functions such as interference filtering based on strain spatial distribution characteristics, multi-dimensional threshold judgment, and automatic identification of failure sensing units, serving as the core hardware support for realizing the intelligent anti-interference and highly robust monitoring of this application; Third, such as Figure 1 and Figure 2 As shown, the strain sensor array 2 is entirely built into the carrier 1 and is not exposed to the outside air. This effectively avoids the erosion and interference of external environmental factors such as water vapor, sweat, medicine, and physical friction on the strain sensor array 2, ensuring the long-term stability of sensing performance and monitoring accuracy.

[0035] The signal processing module is electrically connected to the strain sensor array 2 and is used to receive and process multiple electrical signals. In some embodiments, the signal processing module includes a signal acquisition unit, a processing unit, and a signal output unit. The signal processing module integrates and analyzes the acquired multiple electrical signals to obtain deformation information that reflects wound swelling and tension changes, and compares this deformation information with a pre-set threshold. When the deformation information exceeds the preset threshold range, the signal processing module determines that the wound condition is abnormal and outputs a corresponding alarm signal to achieve automatic identification and timely warning of abnormal wound conditions. This replaces subjective human judgment, eliminates human experience errors, and can accurately identify wound complications and issue timely warnings through early abnormal changes reflected by strain information, thus gaining golden time for clinical intervention and demonstrating strong clinical applicability.

[0036] This application provides a wound monitoring device for a target object 5, including a carrier 1, a strain sensor array 2, and a signal processing module. A flexible substrate 11 is disposed on one side of the carrier 1. The flexible substrate 11 can cover and conform to the target area where the wound of the target object 5 is located, and can undergo flexible deformation according to the shape changes of the target object 5 within the target area. The strain sensor array 2 is integrated on the flexible substrate 11 and is used to convert the flexible deformation of the flexible substrate 11 into an electrical signal. The signal processing module is electrically connected to the strain sensor array 2 and is used to obtain deformation information based on the electrical signal, compare the deformation information with a preset threshold, and output an alarm signal based on the comparison result. This application, through the conforming and adaptive deformation design of the flexible substrate 11 on one side of the carrier 1, can closely cover and conform to the target area where the wound of the target object 5 is located, and undergo flexible deformation synchronously with the shape changes of the target area, accurately capturing the tension changes of the wound and surrounding tissues within the target area, providing a real and reliable physical signal basis for monitoring. The strain sensor array 2, integrated into the flexible substrate 11, can acquire overall, global deformation information of the wound and surrounding tissues. It can accurately reproduce the overall tension change trend of the wound area and directly convert the synchronous deformation transmitted by the flexible substrate 11 into electrical signals reflecting the tension changes of the target area wound and surrounding tissues. This completes the digital conversion of tension changes into electrical signals, enabling continuous real-time monitoring of tension changes. Furthermore, by setting up a signal processing module electrically connected to the strain sensor array 2, this application can accurately obtain strain information based on the electrical signals. By comparing the strain information with preset thresholds, it achieves automated early warning judgment and alarm signal output, replacing subjective human judgment and eliminating human experience errors. It can accurately identify wound complications and issue timely warnings through early abnormal changes reflected by strain information, gaining valuable time for clinical intervention. This application has strong clinical applicability. Through the application of this application, it solves the problem that current clinical wound monitoring relies heavily on manual observation or uses rigid single-point sensors for measurement, which is difficult to reflect the overall tension change state of the wound area. The monitoring results are one-sided and inaccurate, failing to provide objective, continuous, and accurate assessment and early warning of the wound, easily delaying medical care and rehabilitation.

[0037] like Figure 3 As shown, in some embodiments, the carrier 1 has an encapsulation protective layer 12 on the side opposite to the flexible substrate 11; the signal processing module includes a flexible circuit layer 3, which is stacked between the flexible substrate 11 and the encapsulation protective layer 12; the flexible circuit layer 3 is electrically connected to the strain sensor array 2 integrated on the flexible substrate 11.

[0038] Specifically, a protective encapsulation layer 12 is provided on the side of the carrier 1 opposite to the flexible substrate 11. This protective layer 12 serves as a protective structure for the device. It can be made of flexible, waterproof, stain-resistant, and biocompatible materials, such as flexible polyimide film, waterproof silicone coating, medical waterproof non-woven fabric, or flexible waterproof resin film. Alternatively, it can be made of an insulating protective material with a certain structural strength; the specific material is not limited. Covering the outside of the carrier 1, the protective layer 12 provides physical shielding and protection for the internal circuitry and sensor structures, reducing the impact of external friction, pressure, sweat, and medications on the internal components, thereby improving the overall reliability and lifespan of the device.

[0039] The signal processing module includes a flexible circuit layer 3, which can be a flexible printed circuit board, flexible conductive ink circuit, flexible metal foil circuit, etc. It has good flexibility, ductility and conductivity, and can bend and stretch synchronously with the deformation of the flexible substrate 11 without causing circuit breakage or poor contact due to deformation. The flexible circuit layer 3 is stacked between the flexible substrate 11 and the encapsulation protection layer 12. The stacked arrangement realizes the compact integration of various components, reduces the overall thickness of the device, makes the device lighter and thinner, fits the human skin better, and improves the comfort of patients wearing it. At the same time, the encapsulation protection layer 12 can effectively protect the flexible circuit layer 3 from damage by external physical friction, collision or chemical substances, and further ensure the stability of signal transmission.

[0040] The flexible circuit layer 3 is electrically connected to the strain sensor array 2 integrated on the flexible substrate 11. The electrical connection can be achieved by means of conductive adhesive bonding, metal leads, conductive hole interconnection or flexible contact connection, so as to ensure that the electrical signals generated by the strain sensor array 2 can be stably and continuously transmitted to the flexible circuit layer 3 for processing, thereby providing a reliable data basis for subsequent signal analysis and alarm judgment.

[0041] In some embodiments, the strain sensor array 2 is embedded in the flexible substrate 11; or, the strain sensor array 2 is attached to the side of the flexible substrate 11 facing the flexible circuit layer 3.

[0042] Specifically, in one embodiment, the strain sensor array 2 is embedded in the flexible substrate 11. Multiple distributed strain sensing units can be pre-embedded in the internal preset grooves or reserved cavities of the flexible substrate 11, and then filled and fixed with flexible encapsulating adhesive, so that the strain sensor array 2 and the flexible substrate 11 form an integral structure. Alternatively, an integral molding process can be used, in which the strain sensing units are directly buried inside the substrate during the fabrication of the flexible substrate 11, ensuring that the sensing units are tightly attached to the substrate without gaps.

[0043] This application embeds a strain sensor array 2 within a flexible substrate 11, completely enclosing the array. This provides effective physical protection, preventing direct contact between the sensor and human skin, thus avoiding friction and irritation. It also prevents external substances like sweat and medications from directly corroding the sensor, extending its lifespan and ensuring stable sensing performance. Furthermore, the tightly integrated strain sensor array 2 with the flexible substrate 11 allows for direct and lossless transmission of deformation force when the substrate deforms. This avoids delays in deformation transmission and signal distortion caused by poor adhesion between the sensor and the substrate, ensuring the strain sensor array 2 can accurately capture subtle tension changes in the wound area and improve the accuracy of monitoring data.

[0044] In another embodiment, the strain sensor array 2 is attached to the side of the flexible substrate 11 facing the flexible circuit layer 3. The strain sensor array 2 can be glued and fixed to the surface of the flexible substrate 11 facing the flexible circuit layer 3 using medical-grade conductive adhesive or double-sided flexible adhesive. Alternatively, a hot-press bonding process can be used to tightly bond the sensor array to the surface of the flexible substrate 11 to ensure a firm bond and prevent it from falling off.

[0045] This application sets the strain sensor array 2 to be attached to the side of the flexible substrate 11 facing the flexible circuit layer 3, ensuring that the strain sensor array 2 and the flexible substrate 11 are closely attached. When the flexible substrate 11 deforms, the sensor array can synchronously follow the deformation, so that the electrical signal can be stably collected. This ensures that the strain sensor array 2 can accurately capture the subtle tension changes in the wound area and improve the accuracy of the monitoring data.

[0046] In some embodiments, the signal processing module is used to acquire the electrical signals of each sensing unit in the strain sensor array 2 to obtain deformation information including the average strain value of the target area; the preset threshold includes a first threshold and a second threshold, and the alarm signal includes a first-level alarm signal and a second-level alarm signal; when the strain value increment of the average strain value exceeds the first threshold in a first preset time, a first-level alarm signal is output; when the average strain value continues to exceed the second threshold in a second preset time, a second-level alarm signal is output.

[0047] Specifically, the signal processing module acquires the electrical signals output by each sensing unit in the strain sensor array 2 in real time and performs comprehensive calculations on the multiple signals to obtain the average strain value reflecting the overall tissue tension state of the target area. By characterizing the overall deformation of the wound area using the average strain value, misjudgments caused by fluctuations in single-point sensor data can be effectively avoided, making the monitoring results more accurately reflect the overall trend of changes such as wound swelling, increased tension, bleeding, or tissue traction, providing a stable and reliable data foundation for subsequent judgment.

[0048] This application pre-sets at least two judgment thresholds, namely a first threshold and a second threshold, and sets corresponding first-level alarm signals and second-level alarm signals to distinguish abnormal wound conditions with different levels of danger and different rates of development.

[0049] In one embodiment, if the average strain value shows a significant and rapid increase within a first preset time period, which can be a short time window of, for example, 30 seconds to 1 minute or 2 minutes to 5 minutes, and the increase in strain value exceeds a first threshold, the signal processing module determines that an acute and sudden abnormality has occurred in the wound area, such as acute bleeding, rapid swelling, wound tearing, or other high-risk conditions, and immediately outputs a Level 1 alarm signal. The Level 1 alarm signal corresponds to a sudden event with a high degree of urgency, enabling rapid early warning and buying time for emergency treatment.

[0050] In another embodiment, if the average strain value remains above a second threshold for a second preset time period, which can be a relatively long time window such as 10 minutes, 15 minutes, or 20 minutes, and the average strain value remains at a high level without significant decline within the second preset time period, the signal processing module determines that a persistent abnormality has occurred in the wound area, such as slow bleeding, progressive swelling, or persistent increase in tissue tension, and outputs a secondary alarm signal accordingly. The urgency level conveyed by the secondary alarm signal is lower than that of the primary alarm signal, but medical staff still need to review and adjust the nursing plan in a timely manner.

[0051] Through the aforementioned grading and judgment mechanism, the wound monitoring device provided in this application can not only automatically identify wound abnormalities, but also distinguish risk levels based on the speed, magnitude, and duration of abnormal changes. This avoids the problem that a single threshold cannot distinguish the degree of urgency, and also reduces misjudgments caused by instantaneous fluctuations and brief motion interference, making the early warning more targeted and more in line with actual clinical needs, and significantly improving the reliability and intelligence level of wound monitoring.

[0052] like Figure 1 and Figure 2 As shown, in some embodiments, it further includes: an alarm 4, which is electrically connected to the signal processing module; the alarm 4 is configured to: output a first alarm prompt when receiving a first-level alarm signal, and output a second alarm prompt different from the first alarm prompt when receiving a second-level alarm signal.

[0053] Specifically, the wound monitoring device also includes an alarm 4, which is electrically connected to the signal processing module. The alarm 4 is used to output clear alarm prompts according to the different levels of alarm signals output by the signal processing module, so that medical staff can quickly identify the urgency of the wound abnormality and take corresponding measures in a timely manner.

[0054] Alarm 4 can employ audible and visual alerts, vibration alerts, and wireless signal transmission modules. It can include buzzers, LED (Light Emitting Diode) indicator lights, miniature vibration motors, Bluetooth alarm modules, and wireless alarm transmission modules, allowing for flexible configuration based on clinical application scenarios. Upon receiving an alarm signal from the signal processing module, alarm 4 can issue an alarm notification in a clear and easily identifiable manner, directly converting abnormal monitoring into on-site alerts and preventing delays in response due to undetected alarm signals.

[0055] This application sets alarm prompts to correspond with alarm levels. When alarm 4 receives a level 1 alarm signal, it outputs a first alarm prompt; when alarm 4 receives a level 2 alarm signal, it outputs a second alarm prompt, different from the first. For example, the first alarm prompt can use a combination of a high-frequency buzzer and a rapidly flashing red indicator light to indicate sudden, high-risk wound abnormalities; the second alarm prompt can use a combination of a low-frequency buzzer and a slowly flashing yellow indicator light to indicate persistent, progressive wound abnormalities. The two prompting methods are clearly distinguishable in terms of sound frequency, light color, or flashing pattern, allowing medical staff to quickly and intuitively differentiate the abnormality level during work, assessing the urgency without needing to check equipment parameters, thus improving clinical response efficiency.

[0056] In some embodiments, the signal processing module is further configured to acquire deformation information including the spatial distribution characteristics of strain in the target region based on the electrical signals of each sensing unit in the strain sensor array 2; when the spatial distribution characteristics of strain are discrete, the signal processing module does not output an alarm signal; when the spatial distribution characteristics of strain are continuous, the signal processing module makes an alarm judgment based on the average strain value.

[0057] Specifically, to further enhance the anti-interference capability of wound monitoring and avoid false alarms caused by non-pathological factors, the signal processing module is also configured to comprehensively judge deformation information by combining the strain spatial distribution characteristics of the target area, thereby effectively distinguishing between real wound abnormalities and interference signals caused by daily activities.

[0058] Based on the electrical signals acquired from each sensing unit in the strain sensor array 2, the signal processing module further analyzes the signal magnitude and distribution location of each unit to obtain the spatial distribution characteristics of strain reflecting the tissue deformation state of the target area. By comparing and fitting the multi-point sensing data in the array, it can be determined whether the deformation in the target area is localized and scattered, or whether it presents a general and continuous trend, providing a spatial dimension basis for alarm judgment.

[0059] When the spatial distribution of strain exhibits discreteness, it typically indicates that deformation occurs only in localized, isolated locations, and the strain signals from each sensing unit show no uniform trend. This is often caused by non-pathological factors such as changes in patient position, limb traction, coughing, turning over, or brief compression of the local skin. These localized, scattered strain changes are unrelated to overall abnormal conditions such as wound bleeding or swelling. Therefore, the signal processing module classifies these changes as interference signals and does not output alarm signals, thus avoiding false alarms caused by daily activities and improving the stability of the monitoring system.

[0060] When the spatial distribution of strain exhibits continuity, it typically indicates that the strain signal shows an overall and consistent upward trend in the wound and surrounding area, with uniform and spreading deformation range, corresponding to real pathological changes such as wound swelling, tissue bleeding, and local hematoma. In this case, the signal processing module confirms that the current change originates from abnormal wound development rather than external interference. It then performs subsequent threshold comparisons and graded alarm judgments based on the aforementioned average strain value, ensuring the authenticity and reliability of the alarm results.

[0061] This application introduces a judgment mechanism based on the spatial distribution characteristics of strain. This embodiment adds spatial dimension filtering logic to the simple numerical judgment, which can accurately eliminate local and discrete interference signals and only alarm for continuous and overall pathological deformations. This significantly reduces the false alarm rate of the equipment in clinical use, makes the monitoring results more consistent with the actual wound condition, and improves the anti-interference ability and recognition accuracy of the wound monitoring system.

[0062] In some embodiments, the signal processing module is further configured to acquire deformation information including the strain change state of the target region based on the electrical signals of each sensing unit in the strain sensor array 2; the preset threshold also includes a time threshold; when the duration of the strain change state is less than the time threshold, the signal processing module does not output an alarm signal; when the duration of the strain change state is greater than or equal to the time threshold, the signal processing module makes an alarm judgment based on the average strain value.

[0063] Specifically, in order to further improve the accuracy of alarm judgment and reduce false alarms caused by transient interference, the signal processing module in this application is also configured to make a comprehensive judgment by combining the duration of strain change state. By introducing a time-dimensional filtering mechanism, it can effectively distinguish between real pathological changes and transient interference signals.

[0064] The signal processing module analyzes and acquires the strain change status of the target area in real time based on the electrical signals collected by each sensing unit in the strain sensor array 2, and monitors whether the strain value increases, fluctuates, or remains abnormal. Simultaneously, preset thresholds also include a time threshold, which can be preset according to clinical monitoring needs to determine whether the strain change is a pathologically significant, persistent abnormality.

[0065] When the duration of the monitored strain change is less than the time threshold, it usually indicates that the strain change is only a transient, brief disturbance, such as a short-term fluctuation caused by non-pathological factors like a patient's momentary limb tremor, a brief cough, or a single minor squeeze. Because such changes are short-lived and do not possess the typical characteristics of pathological wound deterioration, the signal processing module determines them as interference signals and does not output alarm signals, thereby avoiding invalid alarms caused by transient disturbances.

[0066] When the duration of the monitored strain change is greater than or equal to the time threshold, it indicates that the current strain change is persistent and stable, corresponding to real pathological changes such as slow worsening of wound swelling, continuous bleeding, and gradual hematoma formation. At this time, the signal processing module confirms that the change belongs to a clinically significant abnormal state, and then performs threshold comparison and graded alarm judgment based on the aforementioned average strain value to ensure that the alarm results are true and reliable.

[0067] In one embodiment, the time threshold can be set to 20 seconds, 30 seconds, etc. Only when the abnormal strain state lasts for more than the above duration will the system enter the alarm judgment process, and strain fluctuations that appear and disappear instantly will be directly filtered out.

[0068] This application adds a time threshold judgment to the alarm logic, which can further eliminate transient interference from the time dimension on the basis of spatial distribution screening, forming a dual anti-interference mechanism in space and time. This significantly reduces the false alarm rate of the equipment in actual use, makes the alarm judgment more rigorous and reliable, and effectively improves the stability and clinical applicability of the wound monitoring system.

[0069] In some embodiments, the preset threshold also includes a third threshold; the signal processing module is further configured to acquire the real-time strain value of each sensing unit in the target area; when the absolute value of the difference between the real-time strain value of a certain sensing unit and the average strain value at the corresponding time exceeds the third threshold within a third preset time, the signal processing module can determine that the corresponding sensing unit has failed, and remove the electrical signal of the failed sensing unit when acquiring the electrical signal, and obtain the updated average strain value by acquiring the electrical signal of the remaining sensing units in the target area.

[0070] Specifically, to ensure the continuity and reliability of the wound monitoring process and to avoid distortion of the overall monitoring results due to abnormality, failure or strong interference of individual sensing units, the signal processing module in this application is also configured to monitor and intelligently judge the working status of each sensing unit in real time, realize the automatic identification and data removal of failed sensing units, and further improve the robustness and fault tolerance of the system.

[0071] The preset threshold also includes a third threshold, which is a threshold for judging the effectiveness of the sensing unit. This third threshold can be preset according to the sensor's own accuracy, noise level, and clinical monitoring needs. While acquiring the real-time strain values ​​of each sensing unit in the target area, the signal processing module compares the real-time strain value of each sensing unit with the average strain value at the same time, and calculates the absolute value of the difference between the two to determine whether the output of the sensing unit is within a reasonable and reliable range.

[0072] When the absolute value of the difference between the real-time strain value of a certain sensing unit and the average strain value at the corresponding time continuously exceeds the third threshold within the third preset time, it indicates that the output signal of the sensing unit deviates significantly from the normal change trend of the overall area. The signal processing module can then determine that the sensing unit has failed, drifted, been damaged, or is subject to strong local interference and can no longer reflect the true deformation state of the wound area.

[0073] After identifying a failed sensing unit, the signal processing module automatically removes its electrical signal during subsequent signal acquisition and processing, excluding it from the data calculation. It then recalculates the data based solely on the electrical signals of the remaining normally functioning sensing units within the target area to obtain an updated average strain value. Through this dynamic correction mechanism, even if individual nodes in the array malfunction, it will not significantly affect the overall monitoring results, and the system can continue to operate stably and reliably.

[0074] In some embodiments, the third preset time can be set to 10 to 30 seconds, that is, within a short time window that can effectively distinguish between real anomalies and transient noise, a continuous anomaly can be determined as a failure of the sensing unit, which ensures timely identification and avoids misjudgment.

[0075] Furthermore, this application can implement a data rejection mechanism, making full use of the distributed advantages of the strain sensor array 2, effectively solving the problem that the failure of a traditional single-point sensor will cause the entire monitoring system to fail, significantly improving the stability and fault tolerance of the device in long-term clinical wear scenarios, ensuring that the wound monitoring process is uninterrupted, the data is not distorted, and the alarm judgment results are always true and reliable.

[0076] like Figure 1 , Figure 2 and Figure 4 As shown, in some embodiments, the carrier 1 is strip-shaped, and the strip-shaped carrier 1 has a first connecting end 13 and a second connecting end 14, which are detachably connected; wherein, when the first connecting end 13 and the second connecting end 14 are connected, the carrier 1 is annular.

[0077] Specifically, to facilitate stable wrap-around wearing and fixation of the wound monitoring device on the neck, limbs, and other areas, this application provides a strip-shaped carrier 1. The strip-shaped carrier 1 includes a first connecting end 13 and a second connecting end 14 positioned opposite each other. The first connecting end 13 and the second connecting end 14 are detachably connected. The connection method can employ Velcro, buckles, snaps, adhesive tape, adjustable straps, or other structures to facilitate quick assembly and disassembly by medical personnel or patients according to their needs. Figure 4 As shown, the first connecting end 13 can be the rough side of a Velcro strap, and the second connecting end 14 can be the hook side of a Velcro strap. When the first connecting end 13 and the second connecting end 14 are connected to each other, the carrier 1 forms a closed ring structure, which can stably wrap around the patient's neck, limbs, and other monitoring areas that require ring fixation, making the device fit securely and preventing displacement. The detachable connection between the first connecting end 13 and the second connecting end 14 allows the patient to adjust the tightness to suit different body types and monitoring sites, improving the device's versatility and wearing comfort. At the same time, this structure facilitates the wearing, disassembly, and daily cleaning of the device, making it more suitable for long-term, continuous use scenarios for clinical neck and limb wound monitoring.

[0078] This application does not limit the connection position of the first connection end 13 and the second connection end 14 when the patient wears the wound monitoring device. In some embodiments, such as Figure 4 As shown, the connection position between the first connecting end 13 and the second connecting end 14 can be behind the neck, such as... Figure 1 , Figure 2 As shown, the connection position can be in front of the neck or anywhere around the limbs, with no specific restrictions. The choice and adjustment can be made according to the patient's wearing habits, wound location, and the adaptability of the product connection method.

[0079] In some embodiments, the system further includes: an interaction module electrically connected to the signal processing module, the interaction module having a preset model; the interaction module is capable of inputting parameter information and adjusting the preset model according to the parameter information, so as to set the preset threshold of the signal processing module through the preset model.

[0080] Specifically, to meet the personalized monitoring needs of different monitoring scenarios and patients, the preset thresholds used for alarm judgment are more closely aligned with individual circumstances, further improving monitoring accuracy and clinical applicability. The wound monitoring device also includes an interaction module. The interaction module is electrically connected to the signal processing module and can be implemented using a local interaction unit or a wirelessly connected user terminal application, allowing medical staff to input parameters and perform personalized configurations. The interaction module can be a local interaction device such as a touchscreen display or voice interaction unit, or a user terminal application that communicates with the signal processing module via Bluetooth, wireless communication, etc., such as a mobile application, tablet application, or dedicated monitoring terminal application used by medical staff; the specific application is not limited.

[0081] The interactive module has a built-in preset model, which is a pre-built data analysis and threshold calculation model that can adaptively adjust preset thresholds based on patient individual characteristics, surgical type, wound location, and circumferential dimensions. Medical staff can input relevant parameters through the interactive module, including patient identification, surgical type, wound location, neck circumference, and other individual characteristics. The interactive module can then adjust the preset model accordingly based on the input parameters and use the updated preset model to set personalized preset thresholds for the signal processing module.

[0082] For example, patients with different neck circumferences and different surgical methods have significant differences in their tissue deformation space and safe strain range. After entering parameters such as neck circumference and surgical type through the interactive module, the preset model can make personalized fine-tuning of the preset threshold, so that the preset threshold setting is more in line with the individual physiological structure and postoperative recovery characteristics of the patient, avoiding inaccurate monitoring or false alarms and missed alarms caused by uniform and fixed thresholds.

[0083] By setting an interactive module that allows for parameter input and adaptive adjustment of preset models, the wound monitoring device of this application can achieve personalized and refined configuration of preset thresholds used for monitoring and judgment. It can flexibly adapt monitoring standards according to different patients and different surgical scenarios, significantly improving the applicability and monitoring accuracy of the device, making wound monitoring more targeted and scientific, and better meeting the actual needs of clinical precision medicine and personalized nursing.

[0084] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A wound monitoring device for a target object, characterized in that, include: The carrier has a flexible base on one side, which can cover and conform to the target area where the wound of the target object is located, and can flexibly deform with the shape change of the target object in the target area. A strain sensor array, integrated on the flexible substrate, is used to convert the flexible deformation of the flexible substrate into electrical signals; The signal processing module is electrically connected to the strain sensor array and is used to obtain deformation information based on the electrical signal, compare the deformation information with a preset threshold, and output an alarm signal based on the comparison result.

2. The wound monitoring device according to claim 1, characterized in that, The carrier has an encapsulation protective layer on the side opposite to the flexible substrate; The signal processing module includes a flexible circuit layer, which is stacked between the flexible substrate and the encapsulation protective layer. The flexible circuit layer is electrically connected to the strain sensor array integrated on the flexible substrate.

3. The wound monitoring device according to claim 2, characterized in that, The strain sensor array is embedded in the flexible substrate; or, The strain sensor array is attached to the side of the flexible substrate facing the flexible circuit layer.

4. The wound monitoring device according to claim 1, characterized in that, The signal processing module is used to acquire the electrical signals of each sensing unit in the strain sensor array to obtain deformation information including the average strain value of the target region; The preset threshold includes a first threshold and a second threshold, and the alarm signal includes a first-level alarm signal and a second-level alarm signal; When the average strain value increases beyond the first threshold within a first preset time, a level one alarm signal is output. If the average strain value continues to exceed the second threshold within a second preset time, a level two alarm signal is output.

5. The wound monitoring device according to claim 4, characterized in that, Also includes: An alarm device, which is electrically connected to the signal processing module; The alarm is configured as follows: Upon receiving the Level 1 alarm signal, output a first alarm prompt. Upon receiving the secondary alarm signal, a second alarm message different from the first alarm message is output.

6. The wound monitoring device according to claim 4, characterized in that, The signal processing module is also used to acquire deformation information, including the spatial distribution characteristics of strain in the target region, based on the electrical signals of each sensing unit in the strain sensor array. When the strain spatial distribution characteristics are discrete, the signal processing module does not output the alarm signal; When the spatial distribution characteristics of the strain are continuous, the signal processing module makes an alarm judgment based on the average strain value.

7. The wound monitoring device according to claim 6, characterized in that, The signal processing module is also used to acquire deformation information, including the strain change state of the target region, based on the electrical signals of each sensing unit in the strain sensor array. The preset threshold also includes a time threshold; When the duration of the strain change state is less than the time threshold, the signal processing module does not output the alarm signal; When the duration of the strain change state is greater than or equal to the time threshold, the signal processing module makes an alarm judgment based on the average strain value.

8. The wound monitoring device according to claim 4, characterized in that, The preset threshold also includes a third threshold; The signal processing module is also used to acquire the real-time strain values ​​of each sensing unit within the target area; When the absolute value of the difference between the real-time strain value of a certain sensing unit and the average strain value at the corresponding time exceeds the third threshold within a third preset time, the signal processing module can determine that the corresponding sensing unit has failed, and remove the electrical signal of the failed sensing unit when collecting electrical signals, and obtain the updated average strain value by collecting the electrical signals of the remaining sensing units in the target area.

9. The wound monitoring device according to claim 1, characterized in that, The carrier is strip-shaped, and the strip-shaped carrier has a first connecting end and a second connecting end, wherein the first connecting end and the second connecting end are detachably connected. Wherein, when the first connecting end is connected to the second connecting end, the carrier is ring-shaped.

10. The wound monitoring device according to claim 1, characterized in that, Also includes: An interaction module is electrically connected to the signal processing module, and the interaction module has a preset model. The interactive module can input parameter information and adjust the preset model according to the parameter information, so as to set the preset threshold of the signal processing module through the preset model.

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