Vte risk warning and leg circumference intelligent monitoring integrated device

Abstract

The present application belongs to the technical field of medical devices. The present application discloses a VTE risk early warning and leg circumference intelligent monitoring integrated device, which comprises a cross-leg support arranged in an H shape and used for being worn on both lower limbs for positioning the midpoint of the patella; an upper waist circumference tape and a lower waist circumference tape are respectively arranged at the upper ends and the lower ends of the two sides of the cross-leg support; an infrared distance sensor array, a temperature sensor, a thin film pressure sensor and a blood oxygen saturation sensor for mutually cooperating to measure the leg circumference circumference and collect corresponding multi-modal physiological parameters of the human body are arranged on the tape belts of the upper waist circumference tape and the lower waist circumference tape; a controller is further arranged on the cross-leg support through a protective shell, a memory and a wireless communication module are embedded in the controller, and an interaction module is further embedded on the outer wall of the protective shell. The present application has the advantages of being capable of satisfying the synchronous measurement of the leg circumference of both lower limbs, realizing the fusion of multi-modal physiological parameters and the VTE risk grading early warning.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an integrated device for VTE risk warning and intelligent leg circumference monitoring. Background Technology

[0002] In the medical field, deep vein thrombosis (DVT) refers to a disease caused by abnormal blood clotting in deep veins, leading to impaired venous return. It is a major type of venous thromboembolism (VTE) and, due to its high incidence, mortality, and disability rate, it has become the third leading cause of cardiovascular death after ischemic heart disease and stroke. DVT commonly occurs in the lower extremities, and unilateral limb swelling is one of its most prominent and common symptoms. Therefore, measuring changes in the circumference of the affected limb can objectively reflect the improvement or deterioration of venous blood flow and has irreplaceable clinical value for early identification of DVT, evaluation of the effectiveness of thrombolytic and anticoagulant therapy, and dynamic monitoring of the condition.

[0003] Currently, for DVT prevention, both domestic and international DVT prevention guidelines clearly require that the circumference of both lower limbs be measured daily for high-risk patients. The measurement site is the patella, with the patella as the midpoint. The circumference of the thigh is measured 15cm above the midpoint of the patella, and the circumference of the calf is measured 10cm below the midpoint of the patella. By comparing the circumference of the same location in both lower limbs and observing the trend of changes over time, early warning of DVT can be achieved.

[0004] However, in hospital clinical practice, the common method for monitoring the risk of venous thromboembolism (VTE) in hospitalized patients is to use a soft measuring tape, a positioning leg circumference measuring device, or an infrared electronic measuring device to measure the circumference of the patient's thigh and calf.

[0005] First, the soft measuring tape is the most commonly used manual measuring tool in clinical practice for measuring leg circumference. For example, Chinese patent application number 201920225408.7 discloses a special measuring tape for measuring leg circumference in deep vein thrombosis of the lower extremities. This patented technology achieves the positioning and measurement of the upper and lower edges of the patella by fixing the measuring tape to the backing. However, its use has problems such as cumbersome operation, difficulty for a single person to operate, and a large workload and easy error in manually reading and recording data.

[0006] Secondly, currently used positioning-type leg circumference measuring devices, such as the Chinese patent application No. 202022001182.8 which discloses a special leg circumference measuring device for deep vein thrombosis of the lower extremities, use a knee positioning strap and spring mechanism to ensure consistent tape measure tension during each measurement, thus guaranteeing consistency across multiple measurements. However, in practice, using a mechanical tape measure still requires manual pulling, reading, and recording, resulting in low measurement efficiency.

[0007] Third, existing infrared electronic measuring devices, such as the Chinese patent application CN209018738U which discloses an infrared measuring instrument for measuring leg and arm circumference, calculate limb circumference through a ring-shaped airbag and multiple infrared ranging sensors. While this approach represents a breakthrough in measurement automation, it still lacks functions such as multimodal data fusion and risk warning.

[0008] How to solve the above problems has become an urgent technical issue. Summary of the Invention

[0009] The technical problem to be solved by the present invention is to provide an integrated device for VTE risk warning and intelligent leg circumference monitoring that can meet the requirements of simultaneous measurement of leg circumference of both lower limbs, as well as the fusion of multimodal physiological parameters and VTE risk classification and warning.

[0010] To achieve the above objectives, the present invention provides the following technical solution:

[0011] An integrated device for VTE risk warning and intelligent leg circumference monitoring includes an H-shaped straddle brace for wearing on both lower limbs to locate the midpoint of the patella; upper and lower waist circumference rulers are respectively installed on the upper and lower ends of both sides of the straddle brace; each of the upper and lower waist circumference rulers is equipped with an infrared ranging sensor array, a temperature sensor, a thin-film pressure sensor, and a blood oxygen saturation sensor for measuring leg circumference and collecting corresponding multimodal physiological parameters of the human body; a controller is also installed on the straddle brace through a protective shell, the controller has a memory and a wireless communication module embedded in it, and an interaction module is embedded on the outer wall of the protective shell, wherein the driving component of the straddle brace, the infrared ranging sensor array, the temperature sensor, the thin-film pressure sensor, the blood oxygen saturation sensor, and the interaction module are all electrically connected to the controller.

[0012] Preferably, the straddle-type support includes a base, with side electric push rods on both sides of the base that extend and retract laterally to adjust the span distance for patient measurement. Each side electric push rod has a patella positioning structure at its end, detachably connected to the patella and capable of locating the midpoint of the patella. Each patella positioning structure also has an upper electric push rod at its top, connected to the upper waist circumference ruler, with the distance between the upper waist circumference ruler and the midpoint of the patella being 15cm when the push rod end is extended to its maximum stroke. Each patella positioning structure also has a lower electric push rod at its bottom, connected to the lower waist circumference ruler, with the distance between the lower waist circumference ruler and the midpoint of the patella being 10cm when the push rod end is extended to its maximum stroke. The protective shell is located on the outer wall of the base, and the side electric push rods, the sensing components of the patella positioning structure, the upper electric push rod, and the lower electric push rod are all electrically connected to the controller.

[0013] Preferably, the patella positioning structure includes a patella midpoint positioning seat connected to the end of the push rod of the side electric push rod. The surface of the patella midpoint positioning seat is designed with a biomimetic anatomical curved surface structure to fit comfortably against the surface of the human patella. A laser speckle projector for identifying and positioning the midpoint of the human patella and a pressure sensor for collecting the pressure between the patella midpoint positioning seat and the human body to avoid pressure injury are embedded in the patella midpoint positioning seat. A fixing ring is provided on one side of the patella midpoint positioning seat, and a fixing strap is provided on the other side of the patella midpoint positioning seat away from the fixing ring for overlapping and cooperating with the fixing ring to fix the patella midpoint positioning seat on the human lower limb. It also includes Velcro on the fixing strap for sticking the two ends of the fixing strap and the fixing ring together to securely fix the patella midpoint positioning seat on the human lower limb.

[0014] Preferably, the interaction module is a structure that integrates a display module, an indicator module, and a voice broadcast module, wherein the voice broadcast module consists of a voice control chip and a speaker.

[0015] Preferably, the infrared ranging sensor array consists of several sets of infrared ranging sensors, which are arranged circumferentially along the inner wall of the upper or lower waist circumference ruler to collect distance values ​​between the inner wall of the ruler and the limb surface in multiple directions to achieve the measurement of the lower limb leg circumference.

[0016] Preferably, the number of infrared distance sensors on the tape of each of the upper or lower waist circumference measuring tapes is 8-12 sets.

[0017] Preferably, both the upper waist measurement and the lower waist measurement are WT-3557 type automatic telescopic flexible measuring tapes.

[0018] A method for VTE risk early warning and intelligent leg circumference monitoring using the aforementioned integrated device for VTE risk early warning and intelligent leg circumference monitoring, the method comprising the following steps:

[0019] S1. The information acquisition component of the cross-leg brace automatically identifies the midpoint position of the patella of both lower limbs. At the same time, the upper and lower waist circumference rulers, along with the protective shell, controller, memory, wireless communication module and interaction module, are worn on the designated positions of the patient's two lower limbs through the cross-leg brace.

[0020] S2. The controller activates the drive components at the upper ends of both sides of the straddle bracket to extend the upper waist circumference measuring tape to the maximum stroke of 15cm, and activates the drive components at the lower ends of both sides of the straddle bracket to extend the lower waist circumference measuring tape to the maximum stroke of 10cm.

[0021] S3. The upper waist circumference measuring tape is automatically fitted onto the patient's thigh circumference with a predetermined contraction pressure and the position is 15cm above the midpoint of the patella. The lower waist circumference measuring tape is automatically fitted onto the patient's calf circumference with a predetermined contraction pressure and the position is 10cm below the midpoint of the patella. At this time, the corresponding infrared ranging sensor array, temperature sensor, thin film pressure sensor and blood oxygen saturation sensor are all in contact with the patient's skin.

[0022] S4. The infrared ranging sensor array automatically collects the circumference information of the thigh and calf of the patient's two lower limbs and transmits it to the controller for processing to obtain the circumference data of the thigh and calf. At the same time, the measurement data of the upper waist circumference ruler and the lower waist circumference ruler are manually compared and the data is corrected through the interactive module. The skin temperature, wearing contraction pressure and blood oxygen information are collected by temperature sensor, thin film pressure sensor and blood oxygen saturation sensor respectively and transmitted to the controller for processing to obtain the skin temperature, wearing contraction pressure and blood oxygen data. The above-mentioned data are also transmitted to the memory for real-time storage through the controller, thereby satisfying the synchronous measurement of the circumference of the two lower limbs and realizing the acquisition and fusion of multimodal physiological parameters.

[0023] S5. Obtain at least two sets of data on the circumference of the thighs and calves of the same patient, as well as skin temperature, wear systolic pressure, and blood oxygen data, through step S4. Compare the latest data with the historical data according to the predetermined standards and extract the risk feature data. Compare the risk feature data with the predetermined standard risk feature dataset according to the predetermined standards to obtain the VTE risk level.

[0024] S6. The controller transmits VTE risk level information to the interactive module for real-time local prompts. At the same time, the wireless communication module synchronously shares the acquired data and VTE risk level information to the smart terminal for early warning processing, thereby realizing VTE risk classification and early warning.

[0025] Preferably, in step S4, the circumference data of the thigh and calf are obtained in the following way:

[0026] With the infrared ranging sensor array covering the patient's lower limb, the infrared ranging sensor array acquires the distance values ​​d1, d2...d in n directions between the inner wall of the upper or lower waist circumference measuring tape and the limb surface. n Meanwhile, by obtaining the distance between two symmetrically arranged sensors with the largest relative distance in the infrared ranging sensor array to obtain the inner diameter R, the formula for obtaining the approximate circumference C of the lower limb cross section is C=π×R0-Σ(d n ×π / n); and perform polynomial interpolation fitting on n distance sampling points according to preset standards to generate continuous limb contour curves for numerical integration, thereby obtaining the circumference data value of the corresponding body position section of the lower limb;

[0027] Preferably, in step S5, the time interval between acquiring at least two sets of data on the circumference of the thighs and calves of the same patient, as well as skin temperature data, wear compression pressure data, and blood oxygen data, is more than 24 hours.

[0028] Risk characteristic data include at least two of the following: differences in leg circumference measured at the same measurement site in both lower limbs for the same patient; differences in current measurement data compared to the previous measurement data from one hour prior; differences in skin temperature measured at the same measurement site in both lower limbs for the same patient; differences in pressure measured at the same measurement site in both lower limbs for the same patient; and differences in blood oxygen measured at the same measurement site in both lower limbs for the same patient.

[0029] In order to obtain the VTE risk level, the risk characteristic data is compared with the predetermined standard risk characteristic dataset according to the predetermined standard. At the same time, a predetermined individualized dynamic baseline is established based on the measurement data obtained multiple times according to the preset standard.

[0030] Due to the adoption of the above structure, the present invention has the following beneficial effects:

[0031] In this invention, the information acquisition component of a leg-strapping bracket automatically identifies the midpoint position of the patella of both lower limbs, allowing the upper and lower waist circumference scales, along with the protective shell, controller, memory, wireless communication module, and interaction module, to be worn on designated positions on the patient's lower limbs via the leg-strapping bracket. The controller activates the drive components at the upper ends of both sides of the leg-strapping bracket, extending the upper waist circumference scale upwards to its maximum travel of 15cm and the lower waist circumference scale downwards to its maximum travel of 10cm. The scale straps of the upper and lower waist circumference scales automatically fit around the patient's thighs, positioned 15cm and 10cm above the midpoint of the patella, respectively. The corresponding infrared ranging sensor array, temperature sensor, thin-film pressure sensor, and blood oxygen saturation sensor are all in contact with the patient's skin. The infrared ranging sensor array automatically acquires the circumference information of the patient's thighs and calves, transmitting it to the controller for processing to obtain the circumference data of the thighs and calves. Simultaneously, the measurement data from the upper and lower waist circumference scales are manually compared, and data is processed through the interaction module. To ensure measurement accuracy, the system employs a temperature sensor, a thin-film pressure sensor, and a blood oxygen saturation sensor to collect skin temperature, wearing compression pressure, and blood oxygen information, respectively. This data is then transmitted to the controller for processing to obtain skin temperature, wearing compression pressure, and blood oxygen data. The acquired data is also transmitted to a memory for real-time storage, thus enabling simultaneous measurement of the leg circumference of both lower limbs and achieving multimodal physiological parameter acquisition and fusion. By acquiring at least two sets of data from the same patient, including the leg circumference, skin temperature, wearing compression pressure, and blood oxygen, and comparing these data, risk characteristic data can be extracted. This risk characteristic data is then compared with a standard risk characteristic dataset to determine the VTE risk level. The controller transmits the VTE risk level information to the interactive module for real-time local alerts, enabling local warnings. Simultaneously, a wireless communication module synchronously shares the acquired data and VTE risk level information to a smart terminal for remote warning processing, thereby achieving VTE risk grading and early warning. Therefore, this invention has the advantages of simultaneously measuring the leg circumference of both lower limbs, achieving multimodal physiological parameter fusion, and providing VTE risk grading and early warning. Attached Figure Description

[0032] Figure 1 This is a schematic diagram of the integrated VTE risk warning and leg circumference monitoring device described in this invention.

[0033] Figure 2 This is a schematic diagram of the infrared ranging sensor array of the integrated VTE risk warning and leg circumference monitoring device described in this invention;

[0034] Figure 3 This is a circuit connection block diagram of the integrated VTE risk warning and leg circumference monitoring device described in this invention;

[0035] Figure 4 The flowchart shows the VTE risk warning and leg circumference intelligent monitoring method using the integrated device for VTE risk warning and leg circumference intelligent monitoring.

[0036] Figure 5 This is a flowchart illustrating the risk warning process of the VTE risk warning and leg circumference intelligent monitoring method using the integrated device for VTE risk warning and leg circumference intelligent monitoring.

[0037] Explanation of reference numerals in the attached diagram: 1. Leg-straddling bracket; 11. Base; 12. Side electric push rod; 13. Patellar positioning structure; 131. Patellar midpoint positioning seat; 132. Laser speckle projector; 133. Pressure sensor; 134. Fixing ring; 135. Fixing strap; 136. Velcro; 14. Upper electric push rod; 15. Lower electric push rod; 2. Upper waist circumference measuring scale; 3. Lower waist circumference measuring scale; 4. Infrared ranging sensor array; 5. Temperature sensor; 6. Thin-film pressure sensor; 7. Blood oxygen saturation sensor; 8. Protective shell; 41. Controller; 42. Memory; 43. Wireless communication module; 44. Interaction module. Detailed Implementation

[0038] Embodiments of the present invention are described in detail below. Examples of these embodiments are illustrated in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the invention, and should not be construed as limiting the invention. Rather, embodiments of the invention include all variations, modifications, and equivalents falling within the spirit and scope of the appended claims.

[0039] The following description, in conjunction with the accompanying drawings, describes the integrated device for VTE risk warning and intelligent leg circumference monitoring according to an embodiment of the present invention.

[0040] See Figures 1 to 5As shown, this embodiment provides an integrated device for VTE risk warning and intelligent leg circumference monitoring, including an H-shaped straddle bracket 1 for wearing on both lower limbs to locate the midpoint of the patella; an upper waist circumference ruler 2 and a lower waist circumference ruler 3 are respectively provided on the upper and lower ends of both sides of the straddle bracket 1; each of the upper waist circumference ruler 2 and the lower waist circumference ruler 3 is equipped with an infrared ranging sensor array 4, a temperature sensor 5, a thin-film pressure sensor 6, and a blood oxygen saturation sensor 7 for measuring the leg circumference and collecting corresponding multimodal physiological parameters of the human body; a controller 41 is also provided on the straddle bracket 1 through a protective shell 8, and a memory 42 and a wireless communication module 43 are embedded in the controller 41; an interaction module 44 is also embedded on the outer wall of the protective shell 8, wherein the driving component of the straddle bracket 1, the infrared ranging sensor array 4, the temperature sensor 5, the thin-film pressure sensor 6, the blood oxygen saturation sensor 7, and the interaction module 44 are all electrically connected to the controller 41. In this embodiment, the straddle brace 1, upper waist circumference ruler 2, lower waist circumference ruler 3, infrared ranging sensor array 4, temperature sensor 5, thin-film pressure sensor 6, blood oxygen saturation sensor 7, protective shell 8, controller 41, memory 42, wireless communication module 43, and interaction module 44 work together to form an integrated VTE risk warning and leg circumference intelligent monitoring structure. The straddle brace 1 can be extended and adjusted on both sides to adapt to patients with different lower limb spans. The upper waist circumference ruler 2 and lower waist circumference ruler 3 can automatically limit the infrared ranging sensor array 4 to 15cm above the midpoint of the patella on the thigh circumference and 10cm below the midpoint of the patella on the calf circumference, so that the whole device can be worn on the patient's lower limbs to simultaneously measure the circumference of the thigh and calf. In addition, the interaction module 44 can integrate a display module, an indicator module, and a voice broadcast module to adapt to different usage scenarios such as wards, nursing stations, and mobile ward rounds.

[0041] In this embodiment, the straddle-type support 1 includes a base 11. On both sides of the base 11 are side electric push rods 12 that extend and retract laterally to adjust the span distance for patient measurement. At the end of each side electric push rod 12 is a patella positioning structure 13 that is detachably connected to the patella and can locate the midpoint of the patella. Furthermore, at the top of each patella positioning structure 13 is an upper electric push rod 14 connected to the upper waist circumference ruler 2, with the push rod end of the upper electric push rod 14 extending upwards to the maximum... During the maximum stroke, the distance between the upper waist circumference ruler 2 and the midpoint of the patella is 15cm. At the bottom of each patella positioning structure 13, there is a lower electric push rod 15 connected to the lower waist circumference ruler 3. When the push rod end of the lower electric push rod 15 extends to the maximum stroke, the distance between the lower waist circumference ruler 3 and the midpoint of the patella is 10cm. The protective shell 8 is provided on the outer wall of the seat body 11. The side electric push rod 12, the sensing component of the patella positioning structure 13, the upper electric push rod 14, and the lower electric push rod 15 are all electrically connected to the controller 41. The patellar positioning structure 13 includes a patellar midpoint positioning seat 131 connected to the end of the push rod of the side electric push rod 12. The surface of the patellar midpoint positioning seat 131 is designed with a biomimetic anatomical curved surface structure to fit comfortably against the surface of the human patella. A laser speckle projector 132 for identifying and positioning the midpoint of the human patella and a pressure sensor 133 for collecting the pressure of the patellar midpoint positioning seat 131 against the human body to avoid pressure injury are embedded in the patellar midpoint positioning seat 131. A fixing ring 134 is provided on one side of the patellar midpoint positioning seat 131, and a fixing strap 135 is provided on the other side of the patellar midpoint positioning seat 131 away from the fixing ring 134 for overlapping and cooperating with the fixing ring 134 to fix the patellar midpoint positioning seat 131 to the lower limb of the human body. It also includes Velcro 136 provided on the fixing strap 135 for attaching the two ends of the fixing strap 135 and the fixing ring 134 together to securely fix the patellar midpoint positioning seat 131 to the lower limb of the human body.During use, the patellar midpoint positioning seat 131 of the patellar positioning structure 13 is placed on the human patella. The laser speckle projector automatically identifies and positions it to the midpoint of the patella. After adjusting the center point of the patellar midpoint positioning seat 131 to coincide with the midpoint of the patella, under the real-time pressure information collected by the pressure sensor 133, the fixing strap 135 is pulled to move around the back of the lower limb and overlap with the fixing ring 134, tightening it with a predetermined tightening pressure. Then, the two ends of the fixing strap 135 and the fixing ring 134 are securely connected together using Velcro 136, thus securing the leg-stretching bracket 1's base 11, along with the side electric push rod 12 and the patellar positioning structure 13. The upper electric push rod 14 and the lower electric push rod 15 are securely positioned at the midpoint of the patella of the lower limb. Then, as needed, under the constraints of the seat 11 and the protective shell 8, the controller 41 activates the side electric push rod 12 to move the patella positioning structure 13 to the sides to a predetermined span so that the patient's lower limbs can be extended to a comfortable span to fit the patient. The controller 41 then activates the upper electric push rod 14 and the lower electric push rod 15 to move the upper waist circumference ruler 2 upward to 15cm above the midpoint of the patella and the lower waist circumference ruler 3 downward to 10cm below the midpoint of the patella. This facilitates the synchronous control of the measurement point position to enable simultaneous measurement of the circumference of the thigh and calf. The system can synchronously collect multimodal physiological parameter information such as leg circumference data, skin temperature data, fasciculation pressure data, and blood oxygen data through the cooperation of infrared ranging sensor array 4, temperature sensor 5, thin film pressure sensor 6, and blood oxygen saturation sensor 7. This information is then transmitted to controller 41 for processing to obtain multimodal physiological parameters, thereby achieving multimodal physiological parameter acquisition and fusion. The results of multimodal physiological parameters are then output by interaction module 44 and wireless communication module 43. This avoids the positional deviation and data dispersion problems caused by relying on manual point-by-point positioning and leg-by-leg measurement in the prior art, and improves the consistency and comparability of multimodal physiological parameter monitoring such as bilateral lower limb leg circumference measurement.

[0042] In this embodiment, the interaction module 44 is a structure that integrates a display module, an indicator module, and a voice broadcast module, wherein the voice broadcast module is composed of a voice control chip and a speaker.

[0043] In this embodiment, the straddle-type support 1 described herein has an overall H-shaped structure design. The seat 11 serves as the connecting base and can provide structural support to ensure overall lateral stability. The side electric push rods 12 are located at both ends of the seat 11 and can be adjusted in position according to the distance between the patient's lower limbs, body size differences, and nursing scenario needs, thereby adapting to use in patients of different body types, different lying positions, and different ward space conditions, effectively improving the adaptability of use.

[0044] In this embodiment, the surface of the patellar midpoint positioning seat 131 is designed with a biomimetic anatomical curved surface structure, and a laser projector 132 and 4-6 pressure sensors 133 are embedded on its inner side. The surface of the patellar midpoint positioning seat 131 is designed with a biomimetic anatomical curved surface structure, and its shape is adapted to the contour of the patellar surface of the knee, so that the patellar midpoint positioning seat 131 has a clear anatomical reference basis when it is fitted. The pressure sensors 133 are used to obtain the pressure distribution between the patellar midpoint positioning seat 131 and the knee, and the laser projector 132 is used to provide visual indication and definition of the measurement position of the thigh and the lower leg.

[0045] In this embodiment, the laser projector 132 provides optical indication of the measurement position so that the patellar midpoint positioning seat 131 accurately presses against the patellar surface of the knee. The patellar midpoint positioning seat 131 presses against the patellar surface of both lower limbs. The medial pressure sensor 133 first collects information on the contact pressure distribution and transmits it to the controller 41. The controller 41 processes the collected information to obtain the pressure value to determine whether the patellar midpoint positioning seat 131 is in a reasonable fit. By establishing a repeatable positioning relationship with the patella as a stable anatomical reference, the problem of poor repeatability caused by relying on manual visual inspection or skin marking in the prior art is solved.

[0046] In this embodiment, the push rod ends of the upper electric push rod 14 and the lower electric push rod 15 are not arbitrarily extended or retracted. The upper electric push rod 14 drives the upper waist circumference ruler 2 to extend upward to the corresponding midpoint of the patella by a distance of 15cm, and the lower electric push rod 15 drives the lower waist circumference ruler 3 to extend downward to the corresponding midpoint of the patella by a distance of 10cm. This allows the upper waist circumference ruler 2 and the lower waist circumference ruler 3 to correspond to the clinical routine leg circumference monitoring sites, which is beneficial for the horizontal and vertical comparison of measurement results at different time points.

[0047] In this embodiment, the interaction module 44 is a structure that integrates a display module, an indicator module, and a voice broadcast module, wherein the voice broadcast module is composed of a voice control chip and a speaker.

[0048] In this embodiment, the infrared ranging sensor array 4 consists of several sets of infrared ranging sensors. These infrared ranging sensors are spaced circumferentially along the inner wall of the upper waist circumference ruler 2 or lower waist circumference ruler 3 to collect distance values ​​in multiple directions between the inner wall of the ruler and the limb surface, thereby achieving the measurement of the lower limb leg circumference. The number of infrared ranging sensors on each upper waist circumference ruler 2 or lower waist circumference ruler 3 is 8-12 sets.

[0049] In this embodiment, the infrared ranging sensor array 4 is used to acquire distance information between the inner wall of the upper waist circumference ruler 2 or lower waist circumference ruler 3 and the surface of the measured limb from multiple directions. The temperature sensor 5 is used to collect local skin temperature data. The thin-film pressure sensor 6 is used to acquire contact pressure data during the contact process between the upper waist circumference ruler 2 or lower waist circumference ruler 3 and the measured limb. The blood oxygen saturation sensor is used to acquire human blood oxygen data, and the data collected by the infrared ranging sensor array 4, temperature sensor 5, and thin-film pressure sensor 6 are transmitted to the controller 41 for processing. By adding the blood oxygen dimension in the same measurement process, the problem of insufficient information and warning basis when judging the local state solely by circumference changes in the prior art can be reduced. The infrared ranging sensor array 4 has 8-12 sets of infrared ranging sensors spaced along the length of the ruler to improve the completeness of the cross-sectional contour reconstruction and the accuracy of the circumference calculation. Once the measuring tape is closed and fitted over the lower limb, the infrared ranging sensor array 4 samples the distance at multiple points along the limb's outer contour. The controller 41 reconstructs the limb's cross-section and calculates its circumference based on the measured distance values. Simultaneously, the thin-film pressure sensor 7 collects contact pressure data when the measuring tape contacts the limb. This multimodal data acquisition method overcomes the problems of relying solely on single leg circumference data to assess risk and the lack of sufficient information dimensions in existing technologies, thus improving the reliability of the data acquisition and monitoring results.

[0050] In this embodiment, both the upper waist measurement ruler 2 and the lower waist measurement ruler 3 are WT-3557 type automatic telescopic flexible measuring tapes.

[0051] In this embodiment, a method for VTE risk warning and intelligent leg circumference monitoring using the aforementioned integrated device for VTE risk warning and intelligent leg circumference monitoring is also provided. The method includes the following steps:

[0052] S1. The information acquisition component of the straddle brace 1 automatically identifies the midpoint position of the patella of both lower limbs. At the same time, the upper waist circumference ruler 2 and the lower waist circumference ruler 3, together with the protective shell 8, controller 41, memory 42, wireless communication module 43 and interaction module 44, are worn on the designated positions of the patient's two lower limbs through the straddle brace 1.

[0053] S2. The controller 41 starts the drive components at the upper ends of both sides of the straddle bracket 1 to drive the upper waist circumference ruler 2 to extend upward to the maximum stroke of 15cm, and starts the drive components at the lower ends of both sides of the straddle bracket 1 to drive the lower waist circumference ruler 3 to extend downward to the maximum stroke of 10cm.

[0054] S3. The upper waist circumference ruler 2 is automatically fitted onto the patient's thigh circumference with a predetermined contraction pressure and the position is 15cm above the midpoint of the patella. The lower waist circumference ruler 3 is automatically fitted onto the patient's calf circumference with a predetermined contraction pressure and the position is 10cm below the midpoint of the patella. At this time, the corresponding infrared ranging sensor array 4, temperature sensor 5, thin film pressure sensor 6 and blood oxygen saturation sensor 7 are all in contact with the patient's skin.

[0055] S4. The infrared ranging sensor array 4 automatically collects the circumference information of the thigh and calf of the patient's two lower limbs and transmits it to the controller 41 for processing to obtain the circumference data of the thigh and calf. At the same time, the measurement data of the upper waist circumference ruler 2 and the lower waist circumference ruler 3 are manually compared and the data is corrected through the interaction module 44. The skin temperature, wearing contraction pressure and blood oxygen information are collected by the temperature sensor 5, the thin film pressure sensor 6 and the blood oxygen saturation sensor 7 respectively and transmitted to the controller 41 for processing to obtain the skin temperature, wearing contraction pressure and blood oxygen data. The above-mentioned data are also transmitted to the memory 42 for real-time storage through the controller 41, thereby satisfying the synchronous measurement of the circumference of the thighs of both lower limbs and realizing the acquisition and fusion of multimodal physiological parameters.

[0056] S5. Obtain at least two sets of data on the circumference of the thighs and calves of the same patient, as well as skin temperature, wear systolic pressure, and blood oxygen data, through step S4. Compare the latest data with the historical data according to the predetermined standards and extract the risk feature data. Compare the risk feature data with the predetermined standard risk feature dataset according to the predetermined standards to obtain the VTE risk level.

[0057] S6. The VTE risk level information is transmitted to the interaction module 44 for real-time local prompts through the controller 41. At the same time, the acquired data and VTE risk level information are shared to the smart terminal in real time through the wireless communication module 43 to implement early warning processing, thereby realizing VTE risk classification early warning.

[0058] In this embodiment, in step S4, the circumference data of the thigh and calf are obtained in the following way:

[0059] With the infrared ranging sensor array 4 covering the patient's lower limb, the infrared ranging sensor array 4 acquires the distance values ​​d1, d2...d in n directions between the inner wall of the upper waist circumference ruler 2 or the lower waist circumference ruler 3 and the surface of the limb. n Meanwhile, by obtaining the distance between two symmetrically arranged sensors with the largest relative distance in the infrared ranging sensor array 4, the inner diameter R0 is obtained. Therefore, the approximate circumference C of the lower limb cross-section is obtained using the formula C = π × R0 - Σ(d n×π / n); and perform polynomial interpolation fitting on n distance sampling points according to preset standards to generate continuous limb contour curves for numerical integration, thereby obtaining the circumference data value of the corresponding body position section of the lower limb;

[0060] In this embodiment, in step S5, at least two sets of data on the circumference of the thighs and calves of the same patient, as well as skin temperature data, wear compression pressure data, and blood oxygen data, are obtained, with the time interval between the two sets being more than 24 hours.

[0061] Risk characteristic data include at least two of the following: differences in leg circumference measured at the same measurement site in both lower limbs for the same patient; differences in current measurement data compared to the previous measurement data 24 hours ago; differences in skin temperature measured at the same measurement site in both lower limbs for the same patient; differences in pressure measured at the same measurement site in both lower limbs for the same patient; and differences in blood oxygen measured at the same measurement site in both lower limbs for the same patient.

[0062] In order to obtain the VTE risk level, the risk characteristic data is compared with the predetermined standard risk characteristic dataset according to the predetermined standard. At the same time, a predetermined individualized dynamic baseline is established based on the measurement data obtained multiple times according to the preset standard.

[0063] In this embodiment, the leg circumference data is acquired by approximating the limb cross-sectional circumference based on the multiple directional distance values ​​output by the infrared ranging sensor array 4 and the inner diameter R0 formed by the ruler. By performing polynomial interpolation fitting and numerical integration on multiple distance sampling points, a circumference value closer to the real cross-sectional contour is obtained. At the same time, calibration is performed using the scale value of the ruler to improve the accuracy of automatic measurement. Interval measurement data of more than 24 hours are introduced as control information so that the measurement results of the same patient at different time points can establish a continuous comparison relationship.

[0064] In this embodiment, after the infrared ranging sensor array 4 completes multi-directional distance acquisition, the controller 41 first determines the distance based on the inner diameter R0 of the measuring ring and the distance values ​​d1, d2...d in each direction. n According to the formula C=π×R0-Σ(d) n The approximate circumference of the current section is calculated by multiplying (π / n). Then, by performing polynomial interpolation fitting on multiple distance sampling points and numerically integrating the fitted continuous contour curve, a smoother circumference result is obtained. This processing method can reduce the data fluctuation problems caused by coarse single-point readings, lack of continuous reference between previous and subsequent measurements, or difficulty in quantifying local tissue states in existing technologies, thereby enhancing the reliability of trend judgment.

[0065] In this embodiment, when the determined risk level is medium or high, a local warning is issued through at least one of the display module, indicator module, and voice broadcast module. Simultaneously, a remote warning is pushed to at least one of the following smart terminals: a nurse station terminal, a mobile nursing terminal, or an instant messaging terminal, via a wireless communication module. This approach solves the problem in existing technologies where measurement is the only capability, making it difficult to establish a timely warning loop.

[0066] In this embodiment, the risk characteristics are not composed of a single measurement index, but rather at least two of the following: differences in leg circumference measured at the same measurement site on both lower limbs for the same patient; differences in the current measurement data value compared to the previous measurement data value 24 hours ago; differences in skin temperature measured at the same measurement site on both lower limbs for the same patient; differences in pressure measured at the same measurement site on both lower limbs for the same patient; and differences in blood oxygen measured at the same measurement site on both lower limbs for the same patient. Based on this, an individualized dynamic baseline is established so that the risk analysis can reflect both the symmetrical changes between the left and right limbs of the patient and the dynamic changes of the same patient at different time points. In addition, the display module, indicator module, and voice broadcast module can output risk levels in a graded manner and, in conjunction with the wireless communication module 43, realize remote push warnings.

[0067] In this embodiment, when not in use, the side electric push rod 12, the upper electric push rod 14, and the lower electric push rod 15 can be activated to retract their push rod ends so that each component is close to the base 11, thereby reducing the size for easy storage, placement, and carrying.

[0068] In specific use of this embodiment, firstly, the patellar midpoint positioning seat 131 of the patellar positioning structure 13 is placed on the human patella. The laser speckle projector automatically identifies and positions it to the midpoint of the human patella. Then, after adjusting the center point of the patellar midpoint positioning seat 131 to coincide with the midpoint of the human patella, under the real-time pressure information collected by the pressure sensor 133, the fixing strap 135 is pulled to move around the back of the lower limb and overlap with the fixing ring 134, tightening it with a predetermined tightening pressure. Then, the two ends of the fixing strap 135 and the fixing ring 134 are securely glued together using Velcro 136, thereby securing the seat 11 of the straddle-type bracket 1 along with the side electric push rod 12. The patellar positioning structure 13, upper electric push rod 14, and lower electric push rod 15 are securely positioned at the midpoint of the patella of the lower limb. This allows the upper waist circumference ruler 2 and lower waist circumference ruler 3, along with the protective shell 8, controller 41, memory 42, wireless communication module 43, and interaction module 44, to be worn on the designated positions of the patient's lower limbs via the leg-stretching bracket 1. Next, as needed, under the constraints of the seat 11 and protective shell 8, the controller 41 activates the side electric push rod 12, causing the patellar positioning structure 13 to move laterally to a predetermined span, allowing the patient's lower limbs to extend to a comfortable span for use. Then, the controller 41 activates the upper electric push rod 14 and lower electric push rod 15. The push rod 15 operates to extend the upper lumbar circumference ruler 2 upwards to a position 15cm above the midpoint of the patella, and to extend the lower lumbar circumference ruler 3 downwards to a position 10cm below the midpoint of the patella. Then, the strap of the upper lumbar circumference ruler 2 is automatically positioned on the patient's thigh circumference with a predetermined contraction pressure, 15cm above the midpoint of the patella; and the strap of the lower lumbar circumference ruler 3 is automatically positioned on the patient's calf circumference with a predetermined contraction pressure, 10cm below the midpoint of the patella. At this time, the corresponding infrared ranging sensor array 4, temperature sensor 5, thin-film pressure sensor 6, and blood oxygen saturation sensor 7 are all in contact with the patient's skin. Then, the infrared ranging sensor array 4 automatically collects data from the patient's bilateral... The circumference information of the thigh and calf of the lower limbs is transmitted to the controller 41 for processing to obtain the circumference data of the thigh and calf. At the same time, the measurement data of the upper waist circumference ruler 2 and the lower waist circumference ruler 3 are manually compared and the data is corrected through the interaction module 44. The skin temperature, wearing contraction pressure and blood oxygen information are collected by the temperature sensor 5, the thin film pressure sensor 6 and the blood oxygen saturation sensor 7 respectively and transmitted to the controller 41 for processing to obtain the skin temperature, wearing contraction pressure and blood oxygen data. The above-mentioned data are also transmitted to the memory 42 for real-time storage through the controller 41, thereby satisfying the synchronous measurement of the circumference of the legs of both lower limbs and realizing the acquisition and fusion of multimodal physiological parameters.Finally, by acquiring at least two sets of data on the circumference of the lower limbs of the same patient, as well as skin temperature, systolic pressure, and blood oxygen saturation, the latest acquired data is compared with historical data according to predetermined standards to extract risk characteristic data. This risk characteristic data is then compared with a predetermined standard risk characteristic dataset to determine the VTE risk level. The VTE risk level information is transmitted to the interaction module 44 for real-time local notification via the controller 41. Simultaneously, the wireless communication module 43 synchronously shares the acquired data and VTE risk level information to the smart terminal for early warning processing, thereby achieving VTE risk grading and early warning.

[0069] In summary, the structure and method described above have the advantages of being able to simultaneously measure the leg circumference of both lower limbs and to achieve multimodal physiological parameter fusion and VTE risk classification and early warning.

[0070] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.

Claims

1. A VTE risk warning and leg circumference intelligent monitoring integrated device, comprising an H-shaped straddle brace (1) for wearing on both lower limbs to locate the midpoint of the patella; characterized in that: Upper waist circumference measuring tape (2) and lower waist circumference measuring tape (3) are respectively provided on the upper and lower ends of both sides of the straddle bracket (1); infrared ranging sensor array (4), temperature sensor (5), thin film pressure sensor (6) and blood oxygen saturation sensor (7) are provided on the measuring tapes of the upper waist circumference measuring tape (2) and lower waist circumference measuring tape (3) for measuring the leg circumference and collecting the corresponding multimodal physiological parameters of the human body; a controller (41) is also provided on the straddle bracket (1) through the protective shell (8), and a memory (42) and wireless communication module (43) are embedded in the controller (41), and an interaction module (44) is also embedded on the outer wall of the protective shell (8). The driving component, infrared ranging sensor array (4), temperature sensor (5), thin film pressure sensor (6), blood oxygen saturation sensor (7) and interaction module (44) of the straddle bracket (1) are all electrically connected to the controller (41).

2. The integrated device for VTE risk warning and intelligent leg circumference monitoring according to claim 1, characterized in that, The straddle brace (1) includes a base (11). On both sides of the base (11) are side electric push rods (12) that extend and retract laterally to adjust the span for patient measurement. At the end of each side electric push rod (12) is a patellar positioning structure (13) detachably connected to the patellar position and capable of locating the midpoint of the patella. At the top of each patellar positioning structure (13) is an upper electric push rod (14) connected to the upper waist circumference measuring scale (2). When the push rod end of the upper electric push rod (14) extends to its maximum stroke, the upper... The distance between the waist circumference ruler (2) and the midpoint of the patella is 15cm. At the bottom of each patella positioning structure (13), there is a lower electric push rod (15) connected to the lower waist circumference ruler (3). When the push rod end of the lower electric push rod (15) extends to the maximum stroke, the distance between the lower waist circumference ruler (3) and the midpoint of the patella is 10cm. The protective shell (8) is provided on the outer wall of the seat (11). The side electric push rod (12), the sensing component of the patella positioning structure (13), the upper electric push rod (14), and the lower electric push rod (15) are all electrically connected to the controller (41).

3. The integrated device for VTE risk warning and intelligent leg circumference monitoring according to claim 2, characterized in that, The patella positioning structure (13) includes a patella midpoint positioning seat (131) connected to the end of the push rod of the side electric push rod (12). The surface of the patella midpoint positioning seat (131) is designed with a biomimetic anatomical curved surface structure to fit comfortably against the surface of the human patella. A laser speckle projector (132) for identifying and positioning the midpoint of the human patella and a pressure sensor (133) for collecting the pressure of the patella midpoint positioning seat (131) against the human body to avoid pressure injury are embedded in the patella midpoint positioning seat (131). A fixing ring (134) is provided on one side of the seat (131), and a fixing strap (135) is provided on the other side of the patellar midpoint positioning seat (131) away from the fixing ring (134) for overlapping and cooperating with the fixing ring (134) to fix the patellar midpoint positioning seat (131) on the lower limb of the human body. It also includes Velcro (136) provided on the fixing strap (135) for attaching the two ends of the fixing strap (135) and the fixing ring (134) together to securely fix the patellar midpoint positioning seat (131) on the lower limb of the human body.

4. The integrated device for VTE risk early warning and intelligent leg circumference monitoring according to claim 1, characterized in that, The interactive module (44) is a structure that integrates a display module, an indicator module, and a voice broadcasting module. The voice broadcasting module consists of a voice control chip and a speaker.

5. The integrated device for VTE risk early warning and intelligent leg circumference monitoring according to claim 1, characterized in that, The infrared ranging sensor array (4) consists of several sets of infrared ranging sensors. The infrared ranging sensors are set circumferentially along the inner wall of the upper waist circumference ruler (2) or lower waist circumference ruler (3) to collect distance values ​​between the inner wall of the ruler and the surface of the limb in multiple directions to realize the measurement of the leg circumference of the lower limb.

6. The integrated device for VTE risk warning and intelligent leg circumference monitoring according to claim 5, characterized in that, The number of infrared distance sensors on the tape of each of the upper waist circumference rulers (2) or lower waist circumference rulers (3) is 8-12 sets.

7. The integrated device for VTE risk early warning and intelligent leg circumference monitoring according to claim 1, characterized in that, The upper waist circumference measuring tape (2) and the lower waist circumference measuring tape (3) are both WT-3557 type automatic telescopic flexible measuring tapes.

8. A method for VTE risk early warning and intelligent leg circumference monitoring using the integrated device for VTE risk early warning and intelligent leg circumference monitoring as described in any one of claims 1 to 7, characterized in that, The method includes the following steps: S1. The information acquisition component of the cross-leg brace (1) automatically identifies the midpoint position of the patella of both lower limbs. At the same time, the upper waist circumference ruler (2) and the lower waist circumference ruler (3) are worn together with the protective shell (8), controller (41), memory (42), wireless communication module (43) and interaction module (44) on the designated position of the patient's two lower limbs through the cross-leg brace (1). S2. The controller (41) starts the drive components at the upper ends of both sides of the straddle bracket (1) to drive the upper waist circumference ruler (2) to extend to the maximum stroke of 15cm, and starts the drive components at the lower ends of both sides of the straddle bracket (1) to drive the lower waist circumference ruler (3) to extend to the maximum stroke of 10cm. S3. The upper waist circumference ruler (2) is automatically fitted onto the patient's thigh circumference with a predetermined contraction pressure and the position is 15cm above the midpoint of the patella. The lower waist circumference ruler (3) is automatically fitted onto the patient's calf circumference with a predetermined contraction pressure and the position is 10cm below the midpoint of the patella. At this time, the corresponding infrared ranging sensor array (4), temperature sensor (5), thin film pressure sensor (6) and blood oxygen saturation sensor (7) are all in contact with the patient's skin. S4. The infrared ranging sensor array (4) automatically collects the circumference information of the thigh and calf of the patient's two lower limbs and transmits it to the controller (41) for processing to obtain the circumference data of the thigh and calf. At the same time, the measurement data of the upper waist circumference ruler (2) and the lower waist circumference ruler (3) are compared manually and the data is corrected through the interactive module (44). The skin temperature, wearing contraction pressure and blood oxygen information are collected by the temperature sensor (5), the thin film pressure sensor (6) and the blood oxygen saturation sensor (7) respectively and transmitted to the controller (41) for processing to obtain the skin temperature, wearing contraction pressure and blood oxygen data. The above-mentioned data are also transmitted to the memory (42) through the controller (41) for real-time storage, thereby satisfying the synchronous measurement of the circumference of the thighs of the two lower limbs and realizing the acquisition and fusion of multimodal physiological parameters. S5. Obtain at least two sets of data on the circumference of the thighs and calves of the same patient, as well as skin temperature, wear systolic pressure, and blood oxygen data, through step S4. Compare the latest data with the historical data according to the predetermined standards and extract the risk feature data. Compare the risk feature data with the predetermined standard risk feature dataset according to the predetermined standards to obtain the VTE risk level. S6. The VTE risk level information is transmitted to the interaction module (44) through the controller (41) for real-time local prompting. At the same time, the acquired data and VTE risk level information are shared to the smart terminal in real time through the wireless communication module (43) to implement early warning processing, thereby realizing VTE risk classification early warning.

9. The VTE risk warning and intelligent leg circumference monitoring method according to claim 8, characterized in that, In step S4, the circumference data of the thigh and calf are obtained in the following way: With the infrared ranging sensor array (4) covering the patient's lower limb, the infrared ranging sensor array (4) acquires the distance values ​​d1, d2...d in n directions between the inner wall of the upper waist circumference ruler (2) or the lower waist circumference ruler (3) and the surface of the limb. n Meanwhile, by obtaining the distance between two sensors symmetrically arranged and with the largest relative distance in the infrared ranging sensor array (4), the inner diameter is obtained as R0. Then, the formula for obtaining the approximate circumference C of the lower limb cross section is C=π×R0-Σ(d n ×π / n); and perform polynomial interpolation fitting on n distance sampling points according to preset standards to generate continuous limb contour curves for numerical integration, thereby obtaining the circumference data value of the corresponding body position section of the lower limb.

10. The VTE risk warning and intelligent leg circumference monitoring method according to claim 8, characterized in that, In step S5, at least two sets of data are obtained for the circumference of the thighs and calves of the same patient, as well as skin temperature, wear compression pressure, and blood oxygen saturation, with an interval of more than 24 hours between the two sets. Risk characteristic data include at least two of the following: differences in leg circumference measured at the same measurement site in both lower limbs for the same patient; differences in current measurement data compared to the previous measurement data 24 hours ago; differences in skin temperature measured at the same measurement site in both lower limbs for the same patient; differences in pressure measured at the same measurement site in both lower limbs for the same patient; and differences in blood oxygen measured at the same measurement site in both lower limbs for the same patient. In order to obtain the VTE risk level, the risk characteristic data is compared with the predetermined standard risk characteristic dataset according to the predetermined standard. At the same time, a predetermined individualized dynamic baseline is established based on the measurement data obtained multiple times according to the preset standard.

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