Kirschner wire mediated blood flow monitoring device

Abstract

The invention discloses a blood flow monitoring device mediated by a kirschner wire. The device comprises a driving module, a supporting plate, a containing cavity formed in the center of the supporting plate, a data processing module, a processor and a plurality of ultrasonic transducers. The driving module is used for driving the ultrasonic transducers to output ultrasonic signals. The accommodating cavity is used for accommodating a part of a kirschner wire remaining in vitro and is provided with a wire inlet end, the wire inlet end is provided with an elastic contraction opening, and the radius of the elastic contraction opening in a contraction state is smaller than that of the kirschner wire; the plurality of ultrasonic transducers are distributed around the accommodating cavity, and the output ends of the ultrasonic transducers are in the same direction as the needle inserting end; the processor controls the driving module to drive the ultrasonic transducer to output an ultrasonic signal to a region of interest of a target object, and receives a corresponding echo signal; the data processing module is controlled to determine ultrasound data corresponding to the echo signal and to determine predetermined blood flow information for the region of interest based on the ultrasound data. The embodiment of the invention can monitor whether abnormal blood flow information exists in the region of interest in real time.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a blood flow monitoring device mediated by a Kirschner wire. Background Art

[0002] At present, postoperative blood flow monitoring for fracture fixation is crucial in clinical applications. However, most existing blood flow monitoring technologies rely on the naked-eye observation of nurses. Although this method can provide feedback on the blood flow state to a certain extent, since nurses cannot continuously monitor the blood flow of each patient, it is easy to have the problem of delayed detection of blood flow abnormalities. Especially in emergency situations, this may lead to the consequence of blood flow loss, causing irreparable harm to the patient.

[0003] Therefore, there is a need to provide a blood flow monitoring device to solve the problem that the existing technology cannot perform real-time non-invasive blood flow monitoring on patients with fracture fixation. Summary of the Invention

[0004] The present invention provides a blood flow monitoring device mediated by a Kirschner wire to solve the problem that the existing technology cannot perform real-time non-invasive blood flow monitoring on patients with fracture fixation.

[0005] According to an aspect of the present invention, there is provided a blood flow monitoring device mediated by a Kirschner wire, including a driving module, a support plate, a receiving cavity provided at the center of the support plate, a data processing module, a processor, and a plurality of ultrasonic transducers:

[0006] The driving module is used to drive the plurality of ultrasonic transducers to output ultrasonic signals;

[0007] The receiving cavity is used to receive the part of the Kirschner wire body left outside the body, contains acoustic coupling gel, and is provided with a needle insertion end. The needle insertion end is provided with an elastic shrinkage opening, the elastic shrinkage opening is made of an acoustic impedance material, and the radius of the elastic shrinkage opening in the contracted state is smaller than the radius of the Kirschner wire;

[0008] The plurality of ultrasonic transducers are arranged on the target surface of the support plate and distributed around the receiving cavity, and the output ends of the ultrasonic transducers are in the same direction as the needle insertion end;

[0009] The processor controls the driving module to drive the plurality of ultrasonic transducers to output ultrasonic signals to the region of interest of the target object, and receives the echo signals for the ultrasonic signals; controls the data processing module to determine the ultrasonic data corresponding to the echo signals, and based on the ultrasonic data, determines whether there is abnormal blood flow information in the region of interest, and the region of interest includes the part of the Kirschner wire body left in the target object.

[0010] In the technical solution of the blood flow monitoring device mediated by a Kirschner wire provided by an embodiment of the present invention, since a receiving cavity is provided in the center of the support plate, on the target surface of the support plate, a plurality of ultrasonic transducers are provided around the receiving cavity; the receiving cavity is used to receive the part of the Kirschner wire body left outside the body, there is acoustic coupling gel inside, and a needle insertion end is provided. The needle insertion end is provided with an elastic contraction opening. The elastic contraction opening is made of an acoustic impedance material, and the radius of the elastic contraction opening in the contracted state is smaller than the radius of the Kirschner wire, and the output ends of the ultrasonic transducers are in the same direction as the needle insertion end; the processor can control the driving module to drive the plurality of ultrasonic transducers to output ultrasonic signals to the region of interest of the target object and receive the corresponding echo signals; since the region of interest includes the part of the Kirschner wire body left in the target object's body, the echo signal can obtain information on whether there is abnormal blood flow around the part of the Kirschner wire body left in the target object's body, achieving the technical effect of being able to monitor the blood flow condition around the Kirschner wire in the target object's body in real time. Compared with the traditional human eye observation, the accuracy and real-time performance of blood flow condition monitoring can be significantly improved.

[0011] It should be understood that the content described in this part is not intended to identify the key or important features of the embodiments of the present invention, nor is it used to limit the scope of the present invention. Other features of the present invention will become easily understood through the following description. Brief Description of the Drawings

[0012] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following will briefly introduce the drawings required for the description of the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0013] Figure 1 is a schematic structural diagram of the data acquisition part of the blood flow monitoring device provided by an embodiment of the present invention;

[0014] Figure 2 is a schematic structural diagram of the control part of the blood flow monitoring device provided by an embodiment of the present invention;

[0015] Figure 3 is a schematic diagram of the Kirschner wire for bone fixation provided by an embodiment of the present invention;

[0016] Figure 4 is a flowchart of the abnormal blood flow information monitoring method provided by an embodiment of the present invention.

[0017] 01. Kirschner wire; 1. Support plate; 101. First angle adjustment mechanism; 2. Accommodation cavity; 201 Inner wall of the accommodation cavity; 202. Elastic contraction port; 203. Infrared sensor; 204. Environmental monitoring mechanism; 3. Ultrasonic transducer; 31. Second angle adjustment mechanism; 4. Drive module; 5 - Data processing module; 6 - Processor. Detailed implementation manner

[0018] In order to enable those skilled in the art of the present technology to better understand the solution of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without making creative efforts shall fall within the protection scope of the present invention.

[0019] It should be noted that the terms "first", "second", etc. in the description and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects, and do not necessarily need to be used to describe a specific order or sequence. It should be understood that such data can be interchanged under appropriate circumstances so that the embodiments of the present invention described here can be implemented in an order different from those illustrated or described here. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product or device including a series of steps or units does not necessarily have to be limited to those steps or units clearly listed, but may include other steps or units not clearly listed or inherent to these processes, methods, products or devices.

[0020] Figure 1 This is a schematic structural diagram of the blood flow monitoring device mediated by Kirschner wire provided in the embodiment of the present invention. This embodiment is adapted to apply ultrasonic detection technology to the blood flow monitoring scenario of patients with fracture fixation using Kirschner wire. Combined with Figure 1 With Figure 2, the device includes a support plate 1, a receiving cavity 2 disposed at the center of the support plate 1, a driving module 4, a data processing module 5, a processor 6, and a plurality of ultrasonic transducers 3: the driving module 4 is used to drive the plurality of ultrasonic transducers 3 to output ultrasonic signals; the receiving cavity 2 is used to receive the part of the needle body of the Kirschner wire 01 left outside the body, and is provided with a needle insertion end, and the needle insertion end is provided with an elastic shrinkage opening 202, and the elastic shrinkage opening 202 is made of an acoustic impedance material; the plurality of ultrasonic transducers 3 are disposed on the target surface of the support plate 1 and are distributed around the receiving cavity 2, and the output ends of the ultrasonic transducers 3 are in the same direction as the needle insertion end; the processor 6 controls the driving module 4 to drive the plurality of ultrasonic transducers 3 to output ultrasonic signals to the region of interest of the target object, and receives the echo signals for the ultrasonic signals; controls the data processing module 5 to determine the ultrasonic data corresponding to the echo signals and the predetermined blood flow information corresponding to the ultrasonic data, and the region of interest includes the part of the needle body left in the target object's body.

[0021] After the bone is fixed using a Kirschner wire, most of the Kirschner wire remains inside the body, and only a small part remains outside the body. The receiving cavity in this embodiment can accommodate the part of the needle body of the corresponding Kirschner wire left outside the body, so that the part left outside the body is entirely wrapped by the receiving cavity. In this way, the performance of this part in the ultrasonic data is the same, which can reduce the complexity of the ultrasonic data processing process.

[0022] The receiving cavity 2 is made of a flexible material, such as silicone, polyurethane, or thermoplastic elastomer (TPE). Since the radius of the elastic shrinkage opening in the contracted state is smaller than the radius of the Kirschner wire, after the Kirschner wire is inserted into the receiving cavity, the elastic shrinkage opening can automatically complete the sealing, preventing the acoustic coupling gel in the receiving cavity from flowing out during the ultrasonic examination, and ensuring the safety of the device use.

[0023] In one embodiment, the radius of the elastic shrinkage opening in the maximum diastolic state is less than half of the inner diameter of the receiving cavity. This embodiment can reduce the elastic force requirement for the elastic shrinkage opening on the premise of ensuring good sealing performance after the shrinkage opening shrinks.

[0024] The elastic shrinkage opening is made of an acoustic impedance material. In one embodiment, the needle insertion end is provided with a needle insertion opening, and the needle insertion opening is provided with an O-ring, a silicone gasket, or other biocompatible sealing materials. On this basis, an elastic shrinkage opening is added for further sealing. The material of the elastic shrinkage opening includes but is not limited to silicone, polyurethane, polyvinyl alcohol (PVA), thermoplastic elastomer (TPE), and other possible flexible materials, which can effectively adapt to the external parts of Kirschner wires with different shapes and sizes, and provide good sealing performance and acoustic coupling performance.

[0025] In one embodiment, the radius of the elastic constriction opening in the maximum diastolic state is less than half of the inner diameter of the accommodation cavity. This embodiment can reduce the elastic requirement for the elastic constriction opening.

[0026] In one embodiment, a telescopic cavity structure is provided inside the accommodation cavity 2, which can automatically adjust the space size according to the diameter and insertion depth of the Kirschner wire. The inner wall 201 of the accommodation cavity is provided with multiple layers of annular sealing rings, and these sealing rings are all made of flexible materials such as rubber, having certain elasticity and resilience. When the Kirschner wire is inserted, the sealing rings will closely fit the surface of the needle body to form multiple seals to prevent the leakage of the acoustic coupling gel.

[0027] The output end of the ultrasonic transducer disposed on the support plate 1 is in the same direction as the needle insertion end of the accommodation cavity 2. In this way, in the case where the accommodation cavity 2 accommodates a part of the needle body outside the body, the ultrasonic transducer 3 can be configured to emit ultrasonic waves to the region of interest including the part of the needle body inside the body and receive the echo signal for the ultrasonic waves.

[0028] The support plate 1 can be circular, elliptical, etc., and can be a concave surface or a flat surface. In this embodiment, the specific shape and size of the support plate are not specifically limited herein.

[0029] In one embodiment, the support plate 1 is a concave surface, and the accommodation cavity is disposed at the center of the concave surface.

[0030] In one embodiment, the support plate 1 is a flat surface, and the accommodation cavity is disposed at the center of the flat surface.

[0031] The accommodation cavity 2 is disposed at the center of the support plate 1, and it can penetrate the support plate 1 or not penetrate the support plate 1.

[0032] In one embodiment, the support plate 1 is provided with a first angle adjustment mechanism 101 for adjusting the orientation of the above-mentioned target surface, such as a universal joint. It should be noted that the first angle adjustment mechanism 101 can be set as an automatic angle adjustment mechanism or a manual angle adjustment mechanism. This embodiment completes the adjustment of the orientation of the target surface of the support template through the first angle adjustment mechanism 101, thereby completing the adjustment of the orientation of the needle insertion end of the accommodation cavity and the orientation of the output end of the ultrasonic transducer.

[0033] In one embodiment, the device further includes a display screen and an infrared sensor 203 disposed at the needle insertion end; the infrared sensor 203 is configured to output at least infrared detection light to the space region where the accommodation cavity 2 is located and receive the detection signal corresponding to the infrared detection light; the data processing module 5 is used to determine the current pose of the partial needle body of the Kirschner wire entering the accommodation cavity 2 according to the detection signal; the processor 6 is further configured to control the display screen to display the current pose.

[0034] AsFigure 3 As shown, the region of interest in the figure can be set to the index finger segment where the part of the needle body of the Kirschner wire in the index finger is located, that is, the index finger segment in the dotted box; the infrared sensor 203 can be directly set at the end of the needle entry end of the accommodating cavity 2, and is configured to output infrared detection light to at least the spatial area where the accommodating cavity 2 is located, and receive the reflected detection signal. The data processing module 5 processes the detection signal and identifies the Kirschner wire 01, determines the posture of the part of the needle body of the Kirschner wire entering the accommodating cavity 2 according to the identification result of the Kirschner wire 01, and controls the display screen to display the accommodating cavity 2 and the posture or state of the part of the needle body in the accommodating cavity. Since the accommodating cavity 2 and the ultrasonic transducer 3 are both fixed on the support plate 1, the needle entry end of the accommodating cavity 1 is in the same direction as the output direction of the ultrasonic transducer 3, so according to the posture of the part of the needle body of the Kirschner wire, it is determined whether the output end of the ultrasonic transducer is facing the end of the index finger. For example, if the position of this part of the needle body in the accommodating cavity is a predetermined position, it means that the current angle of the support plate 1 can meet the ultrasonic data acquisition requirements; if the position of this part of the needle body in the accommodating cavity is not a predetermined position, it means that the current angle of the support plate 1 does not meet the ultrasonic data acquisition requirements.

[0035] In one embodiment, the first angle adjustment mechanism 101 of the support plate 1 is a manual adjustment mechanism. When the processor detects that the position of the part of the needle body is not the predetermined position, it controls the display to display the current position, and the user adjusts the orientation of the target surface according to the current position, so that the ultrasonic transducer can collect the maximum blood flow signal. If an abnormality is encountered, the first angle adjustment mechanism needs to be readjusted. After the adjustment is completed, the user needs to manually click the touch screen to confirm, or wait for the processor to detect that the position adjustment meets the predetermined conditions and automatically cancel the warning. After the above conditions are met, the ultrasonic transducer starts ultrasonic detection.

[0036] In one embodiment, the processor 6 automatically completes the adjustment of the first angle adjustment mechanism 101 when detecting that the current posture of the part of the needle body is not the predetermined posture. Alternatively, the display screen is controlled to display the current posture and the adjustment of the first angle adjustment mechanism 101 is automatically completed; the adjustment of the first angle adjustment mechanism 101 is completed by fine-tuning the first angle adjustment mechanism 101 multiple times, and the display screen is controlled to display the current posture of the part of the needle body, and / or the posture of the part of the needle body after the adjustment of the first angle adjustment mechanism 101 is completed.

[0037] In one embodiment, a second angle adjustment mechanism 31 is provided at the top of the ultrasonic transducer 3; the infrared sensor 203 is further configured to emit infrared light in the direction of the needle insertion end; the processor 6 also determines the shape information of the region of interest on the surface of the target object according to the detection signal, and completes the angle adjustment of the second angle adjustment mechanism 31 corresponding to some or all of the ultrasonic transducers according to the shape information and the current pose. In this embodiment, the second angle adjustment mechanism 31 is also called a sound guiding component, and its setting makes the orientation of the output end of the ultrasonic transducer adjustable. The processor 6 automatically completes the angle adjustment of the second angle adjustment mechanism 31 corresponding to some or all of the ultrasonic transducers 3 according to the above current pose and the above shape information, improving the speed and accuracy of determining the orientation of the output ends of the ultrasonic transducers 3, thereby improving the accuracy of the ultrasonic data and the accuracy of the final target blood flow information.

[0038] In one embodiment, the user determines the transducer combination to be adjusted according to the foregoing current pose and the visually estimated shape information of the region of interest, and manually completes the angle adjustment of the second angle adjustment structure 31 corresponding to each ultrasonic transducer in the transducer combination to be adjusted. Among them, the transducer combination to be adjusted is a combination of ultrasonic transducers whose output end orientations are to be adjusted.

[0039] Among them, the predetermined blood flow information includes at least one of blood flow pattern, blood flow velocity, blood flow direction, blood pressure data, eddy current region, blood flow dynamic map, blood vessel state data, three-dimensional blood vessel image, three-dimensional dynamic blood flow model, and abnormal blood flow information.

[0040] In one embodiment, the accommodating cavity 2 is provided with a predetermined volume of acoustic coupling gel, and the predetermined volume is less than the volume of the accommodating cavity, less than or equal to 25% of the volume, and greater than or equal to 5% of the volume. The predetermined volume is preferably 10%-20% of the volume. This embodiment realizes the technical effect of fixing and coupling the Kirschner wire through the acoustic coupling gel.

[0041] Among them, the acoustic coupling gel includes at least one of cross-linked polyacrylic resin, sodium alginate, glycerol, fat, propylene glycol, carboxymethyl, cellulose, amino alcohol, and silicon dioxide.

[0042] In one embodiment, a spiral adjustment ring is designed inside the accommodating cavity 2. After Kirschner wires of different specifications are inserted, the spiral adjustment ring can adaptively change the internal space of the accommodating cavity.

[0043] When using this device for blood flow monitoring, the user needs to insert the Kirschner wire 01 left outside the body into the accommodation cavity 2 from the needle insertion end of the accommodation cavity, and make as much of the Kirschner wire left outside the body enter the accommodation cavity 2 as possible. In one embodiment, before inserting a part of the Kirschner wire left outside the body into the accommodation cavity 2, a thin layer of acoustic coupling gel or hydrogel is coated on the contact surface of the Kirschner wire 01 to improve the coupling efficiency between this part of the needle body and the ultrasonic transducer and reduce the attenuation of ultrasonic signals.

[0044] In one embodiment, the device further includes a remote data transmission module: the processor is further configured to, in response to a remote monitoring instruction, control the remote data transmission module to send the ultrasonic data or the predetermined blood flow information to a set monitoring device. This embodiment allows doctors or nurses to remotely monitor or control the device, improving the convenience of using the device.

[0045] In one embodiment, when the predetermined blood flow information does not meet the predetermined conditions, the processor controls the alarm module to output an alarm message, and the alarm message includes a voice alarm message and an identification prompt message. This embodiment enables users or medical staff to obtain abnormal information of the target object in a timely manner.

[0046] The blood flow monitoring device in the embodiments of the present invention can be configured as a plug-in type, or can be configured as a wireless portable type, or can be configured as a form that can be used with both plug-in and battery. In the case where the blood flow monitoring device includes a battery, the battery is configured to provide power supply for a set duration, such as 7 days, 5 days, etc. The device is provided with a power monitoring device to monitor the remaining battery power in real time. When the remaining power is lower than or equal to a predetermined threshold, a corresponding prompt message is output to enable the user to timely understand the remaining power. For example, when it is lower than or equal to the first predetermined threshold, a text prompt message is output; when it is lower than or equal to the second predetermined threshold, a voice alarm message and a corresponding text prompt message are output.

[0047] In one embodiment, the device further includes an environmental monitoring mechanism 204. The environmental monitoring mechanism collects environmental temperature data at set intervals, automatically corrects small changes in blood flow velocity or pulse transit time caused by changes in temperature, etc., and detects and compensates in real time.

[0048] In one embodiment, a temperature sensor is provided inside the accommodation cavity 2 for real-time detection of the temperature inside the accommodation cavity.

[0049] The data processing module 5 further includes a preprocessing unit, which includes a low-noise amplifier and a pre-filter. The noise figure is 0.5 dB, the gain range is 1 to 50 dB, the input return loss is lower than -10 dB, the output return loss is lower than -10 dB, the input and output impedances are 50 Ω, and the operating temperature is from -40 °C to +85 °C. The lower cut-off frequency of the pre-filter is 1 MHz to 2 MHz, the upper cut-off frequency is 40 MHz to 45 MHz, the insertion loss is lower than 1 dB, and the delay is less than 1 millisecond.

[0050] The data processing module 5 includes a blood pressure estimation unit, which calculates blood pressure and pulse transit time, and estimates blood pressure values by dynamically analyzing the dynamic changes of blood flow in blood vessels and the pulse propagation time through ultrasonic signals. The pulse transit time estimates blood pressure by calculating the difference between the time when a cardiac pulse reaches the skin and the time when the pulse propagates through the blood vessels. Specifically:

[0051] PTT = T pulse - T blood vessel .

[0052] Where, T pulse is the time when the pulse conducts to the skin, and T blood vessel is the time when the pulse propagates through the blood vessels.

[0053] After the blood pressure is determined, linear regression models, non-linear regression models, arteriosclerosis index models, vascular compliance models, pulse wave propagation models, etc. of blood pressure and pulse transit time are used to analyze the blood pressure and pulse propagation time to obtain the current vascular state of the region of interest. Among them, the linear regression model is:

[0054] BP = a × PTT + b.

[0055] Where, BP is blood pressure, PTT is pulse transit time, and a and b are constants obtained by fitting the model through experimental data.

[0056] The non-linear model is:

[0057] BP = c × exp(k × PTT).

[0058] Where, c and k are fitting constants. The relationship between pulse transit time and blood pressure in the patient group with relatively severe arteriosclerosis is usually exponential. In one embodiment, based on this data processor module, when the processor detects that the target object belongs to a patient with severe arteriosclerosis, it automatically matches the exponential type for it.

[0059] In one embodiment, the data processing module is further configured to: obtain the echo signal from the ultrasonic transducer, and perform time-frequency analysis and data denoising using an adaptive filtering algorithm to ensure the high quality and accuracy of the data. The time-frequency analysis of the echo signal is achieved through the adaptive filtering algorithm, and the technical effects of real-time noise filtering and enhanced signal contrast are achieved. The specific formula is as follows:

[0060] y(t) = x(t) * h(t).

[0061] Where y(t) is the denoised signal, x(t) is the echo signal, and h(t) is the response function of the filter. A combined algorithm of time-domain filtering and frequency-domain filtering is adopted to adapt to different noise environments. For data denoising, methods such as wavelet transform or Kalman filtering are used to improve the signal quality and further optimize the accuracy of blood flow velocity data, vorticity data, and blood pressure data.

[0062] In one embodiment, the device further includes a storage module. The storage module is equipped with a large-capacity local storage for real-time data storage, and the memory card size is replaceable. It realizes cloud synchronization or synchronization with an electronic health record system through wireless communication modules such as Wi-Fi, Bluetooth, or 4G / 5G, and uses AES-256 encryption.

[0063] In one embodiment, the display screen displays the analysis results in real time, provides a clear graphical interface, and the user can directly operate and adjust parameters.

[0064] In one embodiment, the device further includes a calibration module. The ultrasonic transducer on the support plate is modularly installed, which is convenient for replacing components or upgrading. Different ultrasonic transducers with different functions can be quickly replaced according to requirements, and the calibration module can ensure that the best working state can be achieved every time the ultrasonic transducer is replaced.

[0065] In one embodiment, the device includes a voice recognition module. When the processor detects a voice command based on the voice recognition module, it executes the operation corresponding to the voice command. The operation can be a predetermined blood flow information display operation, a parameter adjustment operation, etc. The voice recognition module preferably includes a noise suppression unit to ensure accurate recognition of the user's voice command even in a noisy environment.

[0066] In an embodiment set, the device includes a self-check module. Based on this self-check module, when the processor detects a power-on signal, it controls the device to enter the self-check mode, controls the display screen to display the self-check progress, and controls each associated module to detect whether the corresponding information is normal. For example, it controls the power monitoring module to detect the battery power, and controls the temperature and humidity sensor to detect the temperature and humidity of the surrounding environment, etc. It should be noted that when the device is used for the first time, the user needs to manually adjust the environmental detection parameters and set the normal range and alarm threshold. After the self-check is completed, the device enters the standby state and controls the display screen to display a prompt message indicating standby.

[0067] For the technical solution of the blood flow monitoring device mediated by a Kirschner wire provided in the embodiments of the present invention, since a receiving cavity is provided in the center of the support plate, on the target surface of the support plate, a plurality of ultrasonic transducers are provided around the receiving cavity; the receiving cavity is used to accommodate the part of the Kirschner wire needle body left outside the body, there is acoustic coupling gel inside, and a needle insertion end is provided. The needle insertion end is provided with an elastic shrinkage opening, the elastic shrinkage opening is made of an acoustic impedance material, and the radius of the elastic shrinkage opening in the contracted state is smaller than the radius of the Kirschner wire, and the output ends of the ultrasonic transducers are in the same direction as the needle insertion end; so that the processor can control the driving module to drive a plurality of ultrasonic transducers to output ultrasonic signals to the region of interest of the target object and receive the corresponding echo signals; since the region of interest includes the part of the needle body left in the target object's body, the echo signal can obtain whether there is abnormal blood flow information around the part of the needle body left in the target object's body, achieving the technical effect of being able to monitor the blood flow condition around the Kirschner wire in the target object's body in real time. Compared with the traditional human eye observation, it can significantly improve the accuracy and real-time performance of blood flow condition monitoring.

[0068] Figure 4 It is a flowchart of the abnormal blood flow information monitoring method provided in the embodiments of the present invention. This embodiment is applicable to determining the ultrasonic data obtained in the foregoing embodiments, and this method can be executed by the above-mentioned processor. As Figure 4 shown, this method includes:

[0069] S110. Determine the blood flow velocity field, the rotational intensity data in the blood flow, and the three-dimensional needle body image of the Kirschner wire according to the ultrasonic data, and determine the three-dimensional blood vessel image of the target blood vessel in the region of interest with the three-dimensional needle body image as a reference.

[0070] Use the Doppler frequency shift formula, combine the difference between the reflected echo frequency and the transmitted frequency, calculate the blood flow velocity in real time, analyze the blood flow direction, and generate a blood flow velocity distribution map.

[0071] Among them, the blood flow velocities in the x-axis direction, y-axis direction, and z-axis direction are determined by the following formulas respectively:

[0072]

[0073]

[0074]

[0075] wherein, f 0 is the ultrasonic emission frequency, V x , V y and V z are the blood flow velocity components in the x-axis direction, y-axis direction and z-axis direction respectively, θ x , θ y and θ z are the angles between the blood flow and the ultrasonic propagation direction respectively, and c is the acoustic wave propagation velocity.

[0076] Therefore, the blood flow velocities in the x-axis direction, y-axis direction and z-axis direction can be respectively expressed as:

[0077]

[0078]

[0079]

[0080] In one embodiment, after the blood flow velocity is determined, the corresponding dynamic blood flow curve can be determined, and then the blood pressure of the target object can be determined based on the dynamic blood flow curve.

[0081] After the blood flow velocity is determined, the rotational intensity data of the blood flow is determined according to the vorticity calculation formula. Among them, the rotational intensity data of the blood flow in the x-axis direction, y-axis direction and z-axis direction are respectively:

[0082]

[0083]

[0084]

[0085] The distance between the target and the ultrasonic transducer is calculated according to the echo time difference and echo intensity in the ultrasonic data, so as to generate a three-dimensional blood vessel image of the blood vessel and a three-dimensional needle body image of the Kirschner wire. Among them, the distance is:

[0086]

[0087] wherein, d is the distance between the target (blood vessel or Kirschner wire) and the ultrasonic transducer, Δt is the echo time of the ultrasonic wave, and c is the acoustic wave propagation velocity. Through the echo signals at different angles and different times, the three-dimensional blood vessel image and the three-dimensional needle body image are calculated, which is convenient for further detection of information such as blood vessel blood flow.

[0088] After the three-dimensional vascular image is determined, the vascular wall information is extracted from the three-dimensional vascular image, and the motion data of the vascular wall is determined based on the vascular wall information; the vascular wall motion analysis and sclerosis evaluation are completed based on the motion data of the vascular wall. Specifically, edge detection algorithms or morphological analysis methods are used to process the vascular wall motion data, and the deformation degree and motion speed of the vascular wall are calculated to evaluate the sclerosis degree of the blood vessel. Specifically:

[0089]

[0090] Among them, dL is the displacement of the vascular wall, and dt is the time interval.

[0091] S120. Determine the three-dimensional target image of the region of interest with the three-dimensional needle body image as a reference.

[0092] Since the pixel values of each position of the three-dimensional needle body are approximately the same and unchanged in the ultrasonic image, taking the three-dimensional needle body image as a reference can be understood as taking the pixel values of each pixel in the three-dimensional needle body image as a reference.

[0093] Specifically, determine the sum of the products between the reference points corresponding to each sampling point in the three-dimensional needle body image and each sampling point in the region of interest; determine the three-dimensional target image of the region of interest according to the sum of the products.

[0094] Specifically, the three-dimensional target image of the region of interest is determined by the following formula:

[0095] I(x,y,z) = ∑ i A i ×f(r i ).

[0096] Among them, (x,y,z) is the reconstructed three-dimensional target image, A i is the reflection intensity of the sampling point labeled i in the region of interest, r i is the reference point corresponding to the sampling point labeled i in the three-dimensional needle body image, and f(r i ) is the echo signal intensity corresponding to this reference point.

[0097] S130. Determine the three-dimensional blood flow dynamic model of the region of interest according to the blood flow velocity field, rotation intensity data, three-dimensional vascular image, and three-dimensional target image.

[0098] Based on the existing three-dimensional blood flow dynamic model generation method, generate a three-dimensional blood flow dynamic model according to the blood flow velocity field, rotation intensity data, three-dimensional vascular image, and three-dimensional target image.

[0099] S140. Determine whether there is abnormal blood flow information in the target object according to the three-dimensional blood flow dynamic model.

[0100] The three-dimensional blood flow dynamic model can display the eddy current region and turbulent region in the blood flow while showing the blood flow velocity field, which helps to judge the vascular state. Therefore, it is possible to determine whether there is abnormal blood flow information in the target object based on the three-dimensional blood flow dynamic model. Among them, the abnormal blood flow information includes, but is not limited to: vascular occlusion, vascular leakage, etc.

[0101] Exemplarily, the ultrasonic emission frequency f 0 is 5 MHz, the ultrasonic velocity C is 1500 m / s. If the measured frequency shift Δf x at the target point is 100 Hz, Δf y is 80 Hz, Δf z is 120 Hz, and the measurement angle θ x is 0°, θ y is 30°, θ z is 60°, then the velocity component is:

[0102]

[0103]

[0104]

[0105] Therefore, the blood flow velocity vector v of the target point is (0.03, 0.021, 0.036) m / s. Similarly, setting a certain coordinate point on a certain ultrasonic cross-section in the blood vessel, the blood flow velocity vectors measured at different times are respectively:

[0106]

[0107]

[0108] t 3 = v(x, y, z) = (0.03, 0.021, 0.036) m / s.

[0109] From the above data, |v(t 3 )| < |v(t 2 )| < |v(t 1 )|, the blood flow velocity decreases with time. At this time, if the certain coordinate point at time t 3 is used as the reference point, then:

[0110] v(x 0 , y 0 , z 0 ) = (v x0 , v y0 , v z0 ) = (0.03, 0.021, 0.036) m / s.

[0111] To analyze the vorticity, the spatial distribution of the velocity field near this point is required. It is assumed that the corresponding velocity components can also be obtained at spatial increments Δx, Δy, Δz that are very small distances from the reference point. Preferably, Δx, Δy, Δz can be taken as 0.001 m, which is the initial setting parameter to meet the requirements of the local linearization approximation of the blood flow velocity field, and is configured as an item that can be modified, and the user can modify it in the setting interface.

[0112] It can be understood that the velocity at (x 0 +Δx, y 0 , z 0 ) is:

[0113]

[0114]

[0115]

[0116] The velocity at (x 0 , y 0 +Δy, z 0 ) is:

[0117]

[0118]

[0119]

[0120] The velocity at (x 0 , y 0 , z 0 +Δz) is:

[0121]

[0122]

[0123]

[0124] The eddy current w is the curl of the velocity field:

[0125]

[0126] Continuing the calculation based on the velocity components of the reference point and its neighboring points in the x, y, and z directions:

[0127]

[0128] Similarly, the above formula can be applied to calculate This embodiment will not be elaborated here.

[0129] When the initial settings of Δx, Δy, and Δz are all 0.001 m:

[0130]

[0131]

[0132]

[0133]

[0134]

[0135]

[0136] According to the above results, the eddy current vector is:

[0137]

[0138]

[0139]

[0140] Therefore, the eddy current vector at this reference point is w = (0.7, -0.4, 0.0) s -1 , achieving a qualitative and quantitative evaluation of the blood flow rotation characteristics at this reference point. The positive and relatively large w x = 0.7 s -1 and the negative w y = -0.4 s -1 components indicate that there is a significant asymmetric rotation structure in the blood flow at this local area, that is, the blood flow near the cross-section of this blood vessel shows a state of rotation with the x-axis as the main rotation axis (due to the relatively large value of w x ) and a certain inclination. This local rotation usually means that the blood flow has deviated from the simple axial steady flow state, presenting complex three-dimensional rotation and secondary flow (secondary flow refers to the rotational backflow mode other than the main flow direction), which is relatively rare in healthy blood vessels. The data of this reference point can be used as an anchor point to compare with the data of the next time point. If the local vorticity decreases or even tends to zero, it represents a deceleration of blood flow or even a cessation of blood transport. If the vorticity component increases sharply and the vorticity component suddenly becomes asymmetric or negative, it represents a leakage of the blood vessel.

[0141] In one embodiment, when abnormal blood flow information of the target object is detected, the control display screen displays the abnormal blood flow information, and the abnormal blood flow information is prompted by voice, and is synchronized to the cloud and the monitoring terminal for remote monitoring and data analysis.

[0142] In one embodiment, the three-dimensional blood flow dynamic model is synchronized to the movement in real time, and the synchronization frequency is a settable item. For example, the user can adjust the synchronization frequency by touching or clicking the corresponding control on the display screen.

[0143] In one embodiment, after the three-dimensional vascular image is determined, the vascular elasticity and vascular expansion and contraction data are determined based on the three-dimensional vascular image, so as to provide additional diagnostic assistance for the possibility analysis in aspects such as the arteriosclerosis index and vascular leakage.

[0144] In one embodiment, the data processing module further includes a pulse unit. Based on this pulse unit, the processor calculates the pulse conduction time according to the propagation time of the blood flow wave from the blood vessel to the skin, and / or estimates the blood pressure through parameters such as blood flow velocity, pulse wave propagation velocity, and blood vessel length. Specifically, a blood pressure estimation model is used to analyze the blood pressure, blood flow dynamic data, vascular elasticity and other data to determine the blood pressure of the target object. Optionally, the parameter weights of the blood pressure estimation model are adjusted according to blood pressure fluctuations; or the parameter weights of the blood pressure estimation model are dynamically adjusted according to data such as the age, gender, blood flow velocity, pulse conduction time, blood pressure fluctuations, and body mass index of the target object.

[0145] In one embodiment, the data processing unit calculates the systolic blood pressure, diastolic blood pressure, and pulse pressure of the target object by comparing data such as the predetermined index data of the blood vessel, blood flow velocity, and pulse conduction time, continuously updates the real-time blood flow data, and dynamically monitors the blood pressure.

[0146] In one embodiment, the blood flow monitoring device further includes an algorithm module. The user can add new algorithms to it or delete one or more algorithms as needed. The processor can be configured to process the corresponding data using any algorithm included in the algorithm module to obtain the required results.

[0147] Each blood flow information determined in this embodiment is stored in a specified location in the memory. When the processor detects a playback instruction, it plays back the blood flow information corresponding to the playback instruction, such as blood pressure, three-dimensional dynamic model, etc. The memory can be a solid-state drive or an expandable memory card. The capacity of the memory can be set according to the actual situation, such as 512GB, 1T, etc.

[0148] The technical solution provided by the embodiments of the present invention can automatically determine the three-dimensional blood flow dynamic model of the region of interest of the target object based on the ultrasonic data collected in the foregoing embodiments, and automatically determine whether there is abnormal blood flow information of the target object according to the three-dimensional blood flow dynamic model, achieving the technical effect of real-time detecting the blood flow state of the target object.

[0149] The blood flow monitoring device 10 includes at least one processor 6 and a memory communicatively connected to the at least one processor, such as a read-only memory (ROM), a random access memory (RAM), etc. The memory stores a computer program executable by the at least one processor. The processor can perform various appropriate actions and processes according to the computer program stored in the read-only memory (ROM) or the computer program loaded from the storage unit into the random access memory (RAM). In the RAM, various programs and data required for the operation of the electronic device 10 can also be stored. The processor, ROM, and RAM are connected to each other via a bus. The input / output (I / O) interface is also connected to the bus.

[0150] Multiple components in the electronic device are connected to the I / O interface, including: an input unit, such as a keyboard, a mouse, etc.; an output unit, such as various types of displays, speakers, etc.; a storage unit, such as a disk, an optical disc, etc.; and a communication unit, such as a network card, a modem, a wireless communication transceiver, etc. The communication unit allows the electronic device to exchange information / data with other devices via a computer network such as the Internet and / or various telecommunication networks.

[0151] The processor 11 can be various general-purpose and / or special-purpose processing components with processing and computing capabilities. Some examples of the processor 11 include, but are not limited to, a central processing unit (CPU), a graphics processing unit (GPU), various dedicated artificial intelligence (AI) computing chips, various processors running machine learning model algorithms, a digital signal processor (DSP), and any appropriate processor, controller, microcontroller, etc. The processor 11 executes the various methods and processes described above, such as the predetermined blood flow information detection method.

[0152] In some embodiments, the predetermined blood flow information detection method can be implemented as a computer program tangibly embodied in a computer-readable storage medium, such as the storage unit 18. In some embodiments, part or all of the computer program can be loaded and / or installed onto the electronic device 10 via the ROM 12 and / or the communication unit 19. When the computer program is loaded into the RAM 13 and executed by the processor 11, one or more steps of the predetermined blood flow information detection method described above can be executed. Alternatively, in other embodiments, the processor 11 can be configured to execute the predetermined blood flow information detection method by any other appropriate means (e.g., by means of firmware).

[0153] The various embodiments of the systems and techniques described above in this specification can be implemented in digital electronic circuitry, integrated circuit systems, field programmable gate arrays (FPGAs), application specific integrated circuits (ASICs), application specific standard products (ASSPs), systems-on-chip (SOCs), complex programmable logic devices (CPLDs), computer hardware, firmware, software, and / or combinations thereof. These various embodiments can include: being implemented in one or more computer programs that are executable and / or interpretable on a programmable system including at least one programmable processor, which can be a special-purpose or general-purpose programmable processor that receives data and instructions from, and transmits data and instructions to, a storage system, at least one input device, and at least one output device.

[0154] The computer programs for implementing the methods of the present invention can be written in any combination of one or more programming languages. These computer programs can be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus, such that the computer programs, when executed by the processor, cause the functions / operations specified in the flowchart and / or block diagram to be implemented. The computer programs can be executed entirely on the machine, partly on the machine, as a stand-alone software package partly on the machine and partly on a remote machine or entirely on the remote machine or server.

[0155] In the context of the present invention, a computer-readable storage medium can be a tangible medium that can contain or store a computer program for use by or in connection with an instruction execution system, apparatus, or device. The computer-readable storage medium can include, but is not limited to, electronic, magnetic, optical, electromagnetic, infrared, or semiconductor systems, apparatus, or devices, or any suitable combination of the foregoing. Alternatively, the computer-readable storage medium can be a machine-readable signal medium. More specific examples of a machine-readable storage medium would include an electrical connection based on one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing.

[0156] To provide interaction with a user, the systems and techniques described herein can be implemented on an electronic device having: a display device for displaying information to the user (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor); and a keyboard and a pointing device (e.g., a mouse or a trackball) through which the user can provide input to the electronic device. Other kinds of devices can also be used to provide interaction with the user; for example, the feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form (including acoustic input, voice input, or tactile input).

[0157] The systems and techniques described herein can be implemented in a computing system that includes backend components (e.g., as a data server), or a computing system that includes middleware components (e.g., an application server), or a computing system that includes frontend components (e.g., a user computer having a graphical user interface or a web browser through which the user can interact with an implementation of the systems and techniques described herein), or a computing system that includes any combination of such backend components, middleware components, or frontend components. The components of the system can be interconnected to each other by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include: local area network (LAN), wide area network (WAN), blockchain network, and the Internet.

[0158] The computing system can include a client and a server. The client and the server are generally remote from each other and typically interact through a communication network. The client-server relationship is created by computer programs running on the respective computers and having a client-server relationship with each other. The server can be a cloud server, also known as a cloud computing server or a cloud host, which is a host product in the cloud computing service system and solves the defects of difficult management and weak business scalability existing in traditional physical hosts and VPS services.

[0159] An embodiment of the present invention also provides a computer program product, including a computer program which, when executed by a processor, implements the predetermined blood flow information detection method provided in any embodiment of the present application.

[0160] In the process of implementing the computer program product, computer program code for performing the operations of the present invention may be written in one or more programming languages or combinations thereof. The programming languages include object-oriented programming languages such as Java, Smalltalk, C++, and also include conventional procedural programming languages such as the "C" language or similar programming languages. The program code may be executed entirely on the user's computer, partially on the user's computer, executed as a stand-alone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the case of a remote computer, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., by using an Internet service provider to connect through the Internet).

[0161] It should be understood that various forms of the flow shown above can be used, steps can be reordered, added or deleted. For example, the steps recited in the present invention can be executed in parallel, sequentially, or in a different order, as long as the desired results of the technical solution of the present invention can be achieved, and no limitation is made herein.

[0162] The above specific embodiments do not constitute a limitation to the protection scope of the present invention. Those skilled in the art should understand that various modifications, combinations, sub-combinations and substitutions can be made according to design requirements and other factors. Any modifications, equivalent substitutions and improvements made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A Kirschner wire-mediated blood flow monitoring device, characterized in that: It includes a driving module, a support plate, a receiving cavity arranged at the center of the support plate, a data processing module, a processor and a plurality of ultrasonic transducers: The driving module is used to drive the multiple ultrasonic transducers to output ultrasonic signals; The accommodating cavity is used to accommodate the part of the Kirschner wire that is retained outside the body, contains sound-conducting glue, and is provided with a needle insertion end, the needle insertion end is provided with an elastic contraction opening, the elastic contraction opening is made of an acoustic impedance material, and the radius of the elastic contraction opening in a contracted state is smaller than the radius of the Kirschner wire; The plurality of ultrasonic transducers are arranged on the target surface of the support plate and distributed around the accommodating cavity, and the output end of the ultrasonic transducer is in the same direction as the needle insertion end; The processor controls the driving module to drive the multiple ultrasonic transducers to output ultrasonic signals to the region of interest of the target object, and receives echo signals for the ultrasonic signals; controls the data processing module to determine ultrasonic data corresponding to the echo signals, and predetermined blood flow information corresponding to the ultrasonic data, wherein the region of interest includes a portion of the needle body retained in the body of the target object.

2. The device according to claim 1, characterized in that The predetermined blood flow information includes at least one of blood flow pattern, blood flow velocity, blood flow direction, blood pressure data, eddy flow area, blood flow dynamic map, blood vessel status data, three-dimensional blood vessel image, three-dimensional dynamic blood flow model and abnormal blood flow information.

3. The device according to claim 1, characterized in that The support plate is provided with a first angle adjustment mechanism for adjusting the orientation of the target surface.

4. The device according to claim 3, characterized in that It also includes a display screen and an infrared sensor arranged at the needle insertion end; The infrared sensor is configured to output infrared detection light at least to the spatial region where the accommodation cavity is located, and receive a detection signal corresponding to the infrared detection light; The data processing module is used to determine the current position of the part of the K-wire body that enters the accommodating cavity according to the detection signal; The processor is further configured to control the display screen to display the current posture.

5. The device according to claim 4, characterized in that The processor is further configured to adjust the orientation of the target surface through the first angle adjustment mechanism according to the current posture.

6. The device according to claim 4, characterized in that A second angle adjustment mechanism is provided at the top of the ultrasonic transducer; The infrared sensor is further configured to emit infrared light in the direction of the needle insertion end; The processor also determines shape information of a region of interest on the surface of the target object according to the detection signal, and completes angle adjustment of the second angle adjustment mechanism corresponding to part or all of the ultrasonic transducers according to the shape information and the current posture.

7. The device according to claim 1, characterized in that The accommodating cavity is provided with a predetermined volume of sound-conducting glue, and the predetermined volume is less than 25% of the volume of the accommodating cavity and greater than 5% of the volume.

8. The device according to claim 1, characterized in that The radius of the elastic contraction opening in the maximum expansion state is less than half of the inner diameter of the accommodating cavity.

9. The device according to claim 1, characterized in that Also includes remote data transmission module: The processor is further configured to, in response to a remote monitoring instruction, control the remote data transmission module to send the ultrasound data or the predetermined blood flow information to a set monitoring device.

10. The device according to claim 1, characterized in that The processor is further configured to execute the following abnormal blood flow information detection method based on the data processing module: Determine the blood flow velocity field, the rotation intensity data in the blood flow, the three-dimensional needle body image of the Kirschner wire, and the three-dimensional blood vessel image of the blood vessel according to the ultrasound data; Determine a three-dimensional target image of the region of interest using the three-dimensional needle image as a reference; Determining a three-dimensional blood flow dynamic model of the region of interest according to the blood flow velocity field, the rotation intensity data, the three-dimensional blood vessel image, and the three-dimensional target image; Determine whether abnormal blood flow information exists in the region of interest according to the three-dimensional blood flow dynamic model.

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