CN116963671A

CN116963671A - Disposable container for diagnosis of rheumatoid arthritis of human finger joints, 3D ultrasound imaging system using said container and application thereof

Info

Publication number: CN116963671A
Application number: CN202180004383.8A
Authority: CN
Inventors: 郝晓辉
Original assignee: Zepu Medical Technology Suzhou Co ltd
Current assignee: Zepu Medical Technology Suzhou Co ltd
Priority date: 2021-02-03
Filing date: 2021-02-03
Publication date: 2023-10-27
Also published as: WO2022165659A1

Abstract

The present invention proposes a fast 3D ultrasonic imaging scanning system and its application in the diagnosis of rheumatoid arthritis of human finger joints. The 3D ultrasound imaging scanning system includes a disposable container (100) configured to contain a liquid and allow a human hand (600) to be immersed in the liquid for ultrasound scanning. The 3D ultrasonic imaging scanning system also includes: a specially designed linear array transducer (200), which covers the entire width of the human hand; a mechanical motion control device (300), which causes the transducer (200) to move along the A track (303) moves to acquire an ultrasound volume of the human hand (600); and an imaging device (400) capable of 3D image reconstruction, analysis and display. The system rapidly acquires a 3D ultrasound volume of a human hand (600) from the front and back of the patient's hand (600), typically in less than 10 minutes, from which the rheumatologist can extract transverse images of all finger joints in the short and longitudinal axes. section.

Description

Disposable container for diagnosis of human finger joint rheumatoid arthritis, 3D ultrasonic imaging system using same and application thereof

Background

The traditional method of monitoring joint disease in Rheumatoid Arthritis (RA) patients is to use X-rays to produce images (radiographs) by exposing the film. This technique proves useful for doctors to grasp the process of joint destruction. Early development of discrete bone destruction (erosion) has been associated with more severe rheumatoid diseases. Although standard radiographs contribute significantly to the clinical assessment of rheumatoid arthritis, they lack sensitivity in the early stages of the disease. This means that the joint must be substantially destroyed before the changes in standard X-ray tests become apparent.

Modern treatment of rheumatoid arthritis is often directed to early stage disease. Accordingly, efforts are continually being made to establish methods for early disease diagnosis. Several radiographic imaging methods have been explored, including Magnetic Resonance Imaging (MRI) and ultrasound examination. MRI scanning was found to be sensitive to early rheumatoid joint destruction indications, but it is very expensive and not widely available. Ultrasound inspection is an attractive imaging method due to its low cost, lack of harmful radiation, and high imaging speed. In recent years, ultrasound has been found to be advantageous in the detection of early bone erosion in rheumatoid arthritis. Studies have shown that when patients develop early rheumatoid arthritis, abnormalities detected by ultrasound examination are 6.5 times more sensitive than abnormalities detected by X-ray film. More results demonstrate this, and more clinicians began using ultrasound imaging for RA. However, rheumatologists find that ultrasound technology is limited by technical performance, requiring appropriate ultrasound examination equipment, in other words, this is a very subtle matter.

Rheumatoid arthritis is a chronic, progressive destructive inflammatory systemic disease based on joints. Synovial hypertrophy initially occurs and local invasive actions lead to cartilage destruction and bone erosion. RA progresses, eventually leading to multiple deformities. All synovial joints are affected; however, the Metacarpophalangeal (MCP) and Proximal Interphalangeal (PIP) joints are the most involved joints. Thus, ultrasound imaging of the hand joint has become an important tool for detecting early bone injuries such as erosion in RA. However, with 15 joints per hand, the clinician needs to acquire 8 scan planes for each joint, the 8 scan planes being lateral and longitudinal scans for anterior, posterior and both sides of the joint, respectively, or a minimum of 4 scans for anterior, posterior lateral and longitudinal scans. Therefore, at least 60 scans are required to fully understand the bone damage of one hand. Each person has two hands, so this is a very tedious and time consuming test. Typically, it takes no less than 1 hour to complete a two-handed assessment of an RA patient. Most rheumatologists are daunting and continue to use X-rays.

Some prior art discusses 3D ultrasound scanning of a human hand to reduce scan times and scan time. However, the container into which the hand is inserted at the time of scanning is difficult to sterilize, and the 3D scanning detailed information is unclear and cannot be achieved.

Thus, there is a need for an innovative scanning solution that can greatly reduce the ultrasound scanning examination time of RA patient hands and simplify the preparation and sterilization of the scanning process.

Disclosure of Invention

1. Problems to be solved

In view of the problems of the prior art in which ultrasonic imaging of the joints of the hands of rheumatoid arthritis patients is time consuming, cumbersome and impractical, the present invention provides an innovative 3D scanning solution that can greatly reduce the examination time of ultrasonic scanning of the hands of RA patients from a minimum of 1 hour to less than 5 minutes.

2. Technical proposal

In order to solve the problems, the technical scheme adopted by the invention is as follows:

the present invention provides a disposable container for diagnosis of rheumatoid arthritis of a human finger joint, the disposable container comprising: the first side surface is perpendicular to the second side surface; wherein the top surface is provided with an opening for allowing a human hand to be placed therein; the first side is provided with a fixing device for fixing the container; the second side or bottom surface is configured as a detection surface for ultrasonic detection.

As a further development of the invention, the securing means comprise one or more lugs, preferably three lugs.

As a further improvement of the present invention, the disposable container is made of a material capable of achieving a sound velocity of 1062.9-1540 m/s and an MRayl acoustic impedance of 1.24-1.5.

As a further development of the invention, the disposable container is made of a material selected from the group consisting of: silicone rubber, polyurethane rubber, or combinations thereof.

As a further development of the invention, the disposable container is made of silicone rubber, which is a material containing one or more additives(EF) silicone rubber, the one or more additives being selected from glycerol (C) ₃ H ₈ O ₃ ) Commercial detergents, alumina, and the like.

The present invention also provides a specialized 3D ultrasound imaging system to acquire 3D ultrasound images of all 15 human hand joints (including wrists) in less than 5 minutes and further analyze and evaluate the bone erosion level of the examined RA patient.

The 3D ultrasound imaging system comprises:

a disposable container configured to hold a human hand to be tested;

a specially designed linear array transducer for full hand scanning;

a mechanical motion control device capable of holding the linear array transducer and moving it along the track to complete a 3D volume scan of a human hand;

an imaging device capable of transmitting ultrasound waves and receiving echoes to form a 2D ultrasound image, and further reconstructing a plurality of 2D ultrasound images having known locations into a plurality of 3D volumes for display and data analysis;

wherein the linear array transducer and the mechanical motion control device are connected with the imaging device, the linear array transducer is clamped by the mechanical motion control device, and the surface of the linear array transducer is coupled with the surface of the disposable container to be in close contact.

As a further improvement of the invention, the material of the disposable container has an acoustic speed of 1540m/s and an acoustic impedance of 1.5 MRayl.

As a further improvement of the invention, the length of the disposable container is 13-25 cm, the width of the disposable container is 6-15 cm, and the height of the disposable container is 15-20 cm. Preferably, the disposable container has dimensions of 25cm×15cm, more preferably 13cm×6cm×20cm.

As a further improvement of the present invention, a specially designed linear array transducer includes:

an elongated acoustic stacking head configured with more than 128 array elements to cover the entire width of a human hand; and

a transducer handle portion configured with a high voltage multiplexer and an inductor tuning unit.

As a further improvement of the present invention, the mechanical motion control device includes: the device comprises a stepping motor, a gear unit, a linear rail and a sliding block; the stepper motor and the gear unit are arranged on top of the linear track, the gear unit is located below the stepper motor, the stepper motor is configured to rotate by command, the gear unit is configured to convert the rotational motion of the stepper motor into linear motion; and the slider is movable on the linear track, and the transducer mount is mounted on the slider such that the transducer mount can move along the linear track with the slider.

As a further improvement of the present invention, wherein the image forming apparatus includes:

a transmitting unit for delivering one or more ultrasonic pulses to a human hand by means of an ultrasonic transducer;

a receiving unit for receiving and processing one or more ultrasonic echoes from a human hand received by the ultrasonic transducer;

a central system control unit configured to control the transmitting unit and the receiving unit;

a 3D scanner control unit configured to control and drive a motor in the mechanical motion control device;

a 3D reconstruction and data preparation unit reconstructing the 3D image for display or further data processing;

an artificial intelligence unit for bone erosion assessment; and

a display for 3D image visualization.

As a further improvement of the present invention, wherein the ultrasound transmitting unit comprises a transmit waveform generator which sends the generated waveforms to the transmit beam forming unit for a corresponding focusing delay, then to the pulse generator, and then transmits the transmit pulses to the ultrasound transducer through the transmit/receive T/R switch unit.

As a further improvement of the present invention, wherein the ultrasound receiving unit includes a receiving front end that amplifies the electronic signal converted from the acoustic wave signal and forms a digital signal by an a/D converter, the converted multi-channel digital signal is dynamically focused in a receiving beam forming unit to form a receiving beam, and then the receiving beam sequentially passes through an intermediate processing unit and an image post-processing unit to form an ultrasound image usable for 3D reconstruction.

In the present invention, the 3D ultrasound imaging system further comprises a detection stage, wherein one or more frames are mounted on the detection stage, the one or more frames being configured for securing the disposable container. For example, the system includes two frames mounted on the inspection station, which can secure the fixture to the first side of the container.

There is provided a method of 3D volume acquisition of a hand rheumatism, the method comprising the steps of:

1) Mounting the disposable container on a test stand, filling the disposable container with a test liquid, preferably water, saline or the like; and immersing the hand in the disposable container;

2) Resetting the mechanical motion control means to move the linear array transducer to the starting position Z ₀ ；

3) Starting 3D volume scanning of the hand, and starting the linear array transducer from a starting position Z ₀ Move to the end position Z _stop The linear array transducer is stopped at each Δz depth to acquire a 2D image;

4) At the end position Z of the movement _stop After that, the linear array transducer is moved back to the initial position Z ₀ ；

5) Turning the hand so that the other side of the hand faces the linear array transducer;

6) By moving the linear array transducer fromStart position Z ₀ Move to the end position Z _stop And stopping at each deltaz depth to acquire a 2D image to restart another 3D volume scan;

7) Based on these two volume scans, 3D images of the front and back of the hand are reconstructed by the imaging device for diagnosis.

As a further improvement of the present invention, the ΔZ depth is set to 0.5mm to 2mm.

3. Advantageous effects

Compared with the prior art, the invention has the following beneficial effects:

(1) According to the invention, the 3D ultrasound imaging system can greatly reduce the examination time of the RA patient's hand ultrasound scan from at least 1 hour to less than 5 minutes, which is a great achievement compared to conventional full hand joint ultrasound scans for more than 1 hour;

(2) According to the invention, the containers for diagnosis of rheumatoid arthritis of the human finger joints are disposable and each container is intended for only one patient;

(3) In accordance with the present invention, a disposable container for diagnosis of rheumatoid arthritis of human finger joints is sized to allow a typical hand to be fully immersed in the container, and to allow space to be left on the front and rear sides of the container so that the hand does not directly contact the container surface and the position of the hand in the container is relatively fixed;

(4) According to the present invention, the material of the disposable container is selected to achieve a sound velocity of 1062.9-1540 m/s and an acoustic impedance of 1.24-1.5 MRayl so that the disposable container can have acoustic impedance and sound velocity close to human tissue, thereby reducing acoustic energy loss when ultrasound waves pass through the walls of the disposable container;

(5) According to the present invention, the disposable container does not need to be cleaned, which greatly reduces the preparation time for examination and reduces the possibility of cross-infection between patients with skin disease;

(6) In the 3D volume acquisition process of the hand rheumatism, the delta Z is set to be 0.5mm-2mm so as to meet the 3D resolution requirement.

Drawings

FIG. 1 illustrates a 3D ultrasound imaging system and disposable container for diagnosis of rheumatoid arthritis of a human finger in accordance with the present invention;

FIG. 2 shows a disposable container for diagnosis of rheumatoid arthritis of a human finger joint according to the present invention;

figure 3 shows how the hand is immersed in a container supported by the frame;

FIG. 4 shows a schematic diagram of a dedicated linear array ultrasound transducer for full hand scanning;

FIG. 5 shows a detailed structure of the mechanical motion control device;

FIG. 6 illustrates another embodiment of a mechanical motion control device, transducer, and disposable container;

fig. 7 shows a block diagram of an image forming apparatus of the present invention;

FIG. 8 gives a graphical illustration of how the transducer moves along the track and examines the hand to construct 3D volumetric data;

FIG. 9 shows a 3D volume scan process for the front and back of the hand;

10A-C illustrate examples of finger joint analysis using 3D volumetric data;

in the figure:

100. a disposable container; 101. a top surface; 102. a bottom surface; 103. a first side; 104. a second side; 110. a fixing device; 200. a linear array transducer; 201. an elongated acoustic stack head; 202. a transducer handle; 210. a high voltage multiplexer; 220. an inductor tuning unit; 300. a mechanical motion control device; 301. a stepping motor; 302. a gear unit; 303. a linear track; 304. a slide block; 305. a transducer mount; 400. an imaging device; 500. a detection table; 510. a frame; 600. a hand; 1102. a T/R switch; 1103. a Tx pulse generator; 1104. a Tx beamformer; 1105. a Tx waveform generator; 1106. a front-end circuit; 1107. an A/D converter; 1108. an Rx beamformer; 1109. an intermediate processor; 1110. an Rx post-processor; 1111. a data preparation unit; 1112. a system control; 1113. a 3D scanner controller; 1114. a motor controller; 1115. an actuator; 1116. an artificial intelligence unit; 1117. a display; 1118. a user interface.

Detailed Description

The present invention will be described in detail below with reference to the accompanying drawings.

Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terms "first," "second," and the like, as used herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. Also, the term "a/an" does not denote a limitation of quantity, but rather denotes the presence of at least one of the referenced item.

Fig. 1 shows a 3D ultrasound imaging system for diagnosis of Rheumatoid Arthritis (RA) of a human finger according to the present invention. The system includes a disposable container 100, a linear array transducer 200, a mechanical motion control device 300, and an imaging device 400. The disposable container 100 is configured to receive and relatively secure a human hand 600 to be tested; the linear array transducer 200 may be used for full hand scanning, the linear array transducer 200 being connected to the imaging device 400 by a cable assembly.

To ensure good contact between the surface of the linear array transducer 200 and the container 100 so that ultrasonic waves can reach the hand 600 without air path obstruction, the system further includes a test station 500, one or more frames 510 mounted on the test station 500, the one or more frames 510 configured to secure the disposable container 100. In fig. 1, two straight plate frames 510 are mounted on the inspection station 500.

The surface of the linear array transducer 200 is closely coupled to the detection surface of the disposable container 100. In some embodiments, the transducer 200 is placed horizontally with its acoustic head facing the detection surface of the container 100 and the transducer surface presses against the detection surface to have intimate contact.

Fig. 2 illustrates the disposable container 100 of fig. 1 designed to eliminate the hassle of container cleaning and to alleviate the task of diagnosis of rheumatoid arthritis in a human finger joint made in accordance with the present invention. The disposable container 100 includes a top surface 101, a bottom surface 102, a first side surface 103, and a second side surface 104; the first side 103 is perpendicular to the second side 104, the top 101 is provided with an opening allowing a person's hand to be placed therein, the first side 103 is provided with a fixing means 110 for fixing the container, and the second side 104 or the bottom 102 is configured as a detection surface for ultrasonic detection. The securing means 110 may comprise one or more lugs, preferably three lugs.

The disposable container 100 is typically filled with a test fluid, which is water, saline, etc., for convenience. A human hand to be inspected is immersed in the container 100 with its front or back facing the inspection surface of the container for inspection. The disposable container 100 is made of a material capable of achieving a speed of sound of 1062.9-1540 m/s and an acoustic impedance of 1.24-1.5 MRayl. The material of the container 100 is selected to be critical so that it can have acoustic impedance and speed of sound close to human tissue and the detection fluid can reduce acoustic energy loss as the ultrasonic waves are transmitted through the container walls.

In some embodiments, the material of the disposable container 100 is a silicone rubber capable of achieving 1062.9m/s acoustic velocity and 1.24MRayl acoustic impedance, preferably comprising one or more additives(EF) silicone rubber, the one or more additives being selected from glycerol (C) ₃ H ₈ O ₃ ) Commercial detergents, alumina, and the like. In another embodiment, a polyurethane rubber (PU) is used instead of a silicone rubber, the polyurethane rubber being capable of producing a sound speed of 1398m/s and an acoustic impedance of 1.42 MRayl.

Furthermore, the container 100 is disposable and is only allowed for one patient. Furthermore, the container 100 is sized to allow for a typical full immersion of the hand and to allow space for the front and rear sides of the container so that the hand does not directly contact the container surface and the position of the hand in the container is relatively fixed.

In one embodiment, the container 100 shown in FIG. 3 is a rectangular container having dimensions of 130X 60X 200mm in length, width and height with an inwardly tapered opening at the top and three lugs for securing. The dimensions are chosen such that an adult's hand can be placed inside the container with the hand being left 15-20mm from both second sides of the container. The two lugs from the bottom of the container 100 serve to secure the container so that the container does not move or shift when the ultrasonic transducer is tightly coupled to and slid over the container. The uppermost lugs are reinforced with PE material to be strong enough to allow the container to hang from the container holding frame when filled with test liquid. In one embodiment, the container 100 is made by an injection molding process.

Fig. 4 details a transducer 200 in a 3D RA imaging system. The transducer 200 includes an elongated acoustic stack head 201 and a transducer handle portion 202, the elongated acoustic head 201 being configured with more than 128 array elements to cover the entire width of a human hand. In one embodiment there are 384 array elements with an array element spacing of 0.3mm and a coverage width of 115mm, which is suitable for most people's hands.

In another embodiment, to drive the 384-element specialized transducer 200, a high voltage multiplexer 210 and an inductor tuning unit 220 are provided within the transducer handle portion 202 to allow signals to be applied to all 384 elements, but to maintain 128 channel signal cables. The signal will further pass through the inductor tuning unit 220 before passing through the cable to the imaging apparatus 400.

The mechanical motion control device 300 may grip the linear array transducer 200 and move it to effect a 3D volume scan of the human hand controlled by the imaging device 400 via a cable assembly. Fig. 5 shows a detailed structure of the mechanical motion control device 300.

The mechanical motion control device 300 may be mounted vertically on the clinical test table 500 (as shown in fig. 1) or horizontally below the test table 500 (as shown in fig. 6). The mechanical motion control device 300 comprises a stepper servo motor 301, a gear unit 302, a linear track 303 and a slider 304, the stepper motor 301 and the gear unit 302 being arranged on top of the linear track 303, the gear unit 302 being located below the stepper motor 301, and the slider 304 being arranged on the linear track 303, wherein said gear unit 302 converts the rotational motion of the motor 301 into a linear up-and-down motion. A transducer mount 305 is mounted on the slider 304 such that the transducer mount 305 can move up and down along the linear track 303 with the slider 304 for a hand in the container during scanning.

In fig. 6, the mechanical motion control device 300 is mounted horizontally under a rectangular container 100, which is also disposable, and the inspection station 500 is specifically designed with a central opening to allow for firm placement and securing of the container 100. The bottom surface 102 of the container 100, which is the detection surface, is large enough to allow the transducer 200 to directly contact during a full scan of a human hand in the container 100.

The transducer 200 is held by a transducer mount 305, which faces upward, and whose surface is tightly coupled to the bottom surface 102 of the container 100. The transducer 200 will move along the track 303 at the bottom of the container 100, controlled by the imaging device 400, while placing the patient's hand parallel to the bottom of the container 100 for 3D volume acquisition of the hand.

Fig. 7 shows a block diagram of an imaging apparatus according to the present invention. The imaging device 400 is capable of forming 2D ultrasound images and further reconstructing 3D images for display and data analysis.

When imaging begins, the system control 1112 sends a command to the 3D scanner controller 1113, which, through the motor controller 1114, controls the motor 301 and the actuator 1115 in the mechanical motion control device 300, first moving the slider 304 to reset the specialized ultrasound transducer 200 to a starting position. Then, upon command from the system control 1112, the imaging device 400 will move the transducer 200 up and down the track 303 according to the starting position to scan the hand within the container 100 to acquire the complete 3D ultrasound volume.

Basically, the transducer 200 will stop at a plurality of positions. At each stop position, the imaging system will acquire a 2D image, and then the transducer 200 is moved down to another position. A frame synchronization signal is applied to control the motion of the motor 301. During a 2D imaging scan, a transmit waveform is generated by Tx waveform generator 1105 and beamformed by Tx beamformer 1104. The Tx pulse generator 1103 forms the final pulse and sends it through the T/R switch 1102 to the specially designed transducer 200. Ultrasound signals are transmitted into the target by the transducer 200. The reflected echoes are received by the same transducer 200 with multiple channels available on the device 400. Each received multichannel signal passes through the T/R switch 1102, and is sent to the receive front-end circuit 1106 for amplification, and then converted into a digital signal by the a/D converter 1107. In the T/R switch 1102, functions of delivering ultrasound pulses and receiving ultrasound echoes may be implemented.

The multi-channel digital Radio Frequency (RF) signal is beamformed in an Rx beamformer 1108 to form a beamsummed RF signal. The RF signal is demodulated, downsampled and low pass filtered in an intermediate processor 1109. The output of the intermediate processor is in-phase and quadrature (IQ) data. The Rx post-processor 1110 performs necessary signal processing on the input IQ data to generate image data for different modes.

Specifically, the Rx post-processor 1110 performs envelope detection, logarithmic compression, and other image enhancement processing techniques to obtain B-mode image data. It applies a phase extraction process to obtain velocity and variance information for blood flow imaging. It also applies fourier transform processing to pulsed doppler, speckle tracking to elastography, dynamic range compression to M-mode imaging, etc. For each 2D scan, the generated 2D image is sent from the Rx post-processor 1110 to the 3D image reconstruction and data preparation unit 1111, where the 2D hand scan image with the control position is reconstructed into a 3D ultrasound volume, which is then prepared for display in a volume visualization scheme or as a cross section at any position and angle, which can be selected by the user from the user interface 1118, which is then indicated by the system control 1112.

The volume or selected cross-section may be sent directly to the display 1117 for display, or it may be sent to an Artificial Intelligence (AI) unit 1116 for bone erosion assessment to generate a file for reference by a clinician, and both the image and erosion index information may be sent to the display 1117 for display. In addition to the 3D scanner controller 1113 and the 3D reconstruction and data preparation unit 1111, the system control unit 1112 also sends imaging and processing instructions to the units from the transducer 200 to the Rx post-processor 1110, and it further receives instructions or sends instructions from the user interface (i.e., console) 1118.

In one embodiment, upon command of the system controls, the mechanical motion control device 300 will cause the slider 304 to move along the track 303 from the starting position Z ₀ Move downwards toPosition Z _stop . As shown in fig. 8, the slider 304 will stop at each Δz depth, the transducer 200 is held by a transducer mount 305 mounted on the slider 304, and the surface of the transducer 200 is tightly coupled with the container 100 to acquire a 2D cross-sectional image of the hand. The hand is in a substantially vertical position relative to the scan plane of the transducer. The acquired multi-planar image will then be sent to the imaging device 400 for 3D reconstruction, acquiring a 3D volume, and then displayed. The Δdepth, Δz, may be adjusted according to the 3D resolution requirements. Preferably, the Δz depth is set to 2mm.

Since ultrasound cannot penetrate the bone, scanning from one side of the hand will not be able to obtain all the data needed for bone erosion analysis, and thus two 3D ultrasound volumes must be acquired per hand. After one-side scanning (e.g., frontal scanning of the hand), the patient will need to flip his hand over and then the other side of the hand again perform the system scan.

In fig. 9, a 3D volume acquisition method of hand rheumatism is described. In step 701, the clinician first installs a new disposable container 100 in the frame 510, fills the container 100 with a test fluid such as water, and then asks the patient to extend his hands into the container 100, thus preparing for a scan.

In step 702, the imaging system 400 resets the mechanical motion control device 300 to move the transducer 200 to the home position Z ₀ And the imaging system 400 completes the other associated imaging initialization process.

In step 703, the imaging system 400 begins a hand 3D volume scan. During the scan, the mechanical motion control device 300 causes the transducer 200 to move from the home position Z ₀ Move to the end position Z _stop And the transducer 200 is stopped at each deltaz depth to acquire a 2D image. As described above, in this process, the transducer acoustic stack lens (i.e., the surface of the transducer) should be tightly coupled to the container surface using a couplant to avoid air interference with the imaging path.

In step 704, when the transducer 200 is moved to the end position Z _stop At this point, the imaging system 400 completes the scan and the transducer 200 will then move back to the home position Z again ₀ 。

After completing the 3D scan of one side, the patient will need to flip his hand over, step 705, with the other side of the hand now facing the transducer acoustic stack surface. There is no particular requirement that the hands have to be placed in exactly the same position within the container, as in practical situations this is not possible, and the container is therefore dimensioned to ensure that the position of the hands in the container is relatively fixed.

Then, in step 706, the imaging system 400 will move the transducer 200 from the home position Z by ₀ Move to the end position Z _stop And stop at each deltaz depth to acquire a 2D frame to restart another 3D scanning process.

In step 707, the imaging device 400 completes the hand-flipped face 3D volume acquisition and resets the transducer 200 to the starting position.

After these two volume scans, the imaging device 400 should obtain two 3D volumes reconstructed, one from the front of the hand and the other from the back of the hand, step 708.

In a typical 3D volume scan, the 3D ultrasound imaging system of the present invention takes about 1-2 minutes to complete a moving depth scan. Plus the time required for the nurse to prepare a new disposable container, and the time required for the patient to reach his hand into the container and then flip over, it takes about 5 minutes, most less than 10 minutes to complete a 3D volume scan of both sides of the hand. This is significantly less than the 40 minute to 1 hour scan time required for conventional hand ultrasound examinations of rheumatisms.

Fig. 10A-C illustrate examples of finger joint analysis using 3D volumetric data. Using the 3D volumetric data, the 3D ultrasound imaging system allows the rheumatist to extract arbitrary cross sections of each hand joint for bone erosion analysis. Fig. 10A shows a 3D reconstruction volume 800. After the 3D hand volume reconstruction, the system allows the clinician to view all acquired 2D pictures (slides), e.g., the center picture 801 in fig. 10A is the picture that the clinician is looking at. The system also allows the clinician to view a picture in an orthogonal direction, e.g., a center picture 802 shown in fig. 10B, showing a longitudinal cross-section finger extracted from the 3D volume dashed marker location. A 3D volume is reconstructed from a plurality of pictures taken of a short axis cross section of the hand. This helps rheumatologists to obtain all three joints of one finger at a time, while also obtaining detailed information about their short axis cross section.

The rheumatist can also pick up a specific finger by applying a selection window on one finger in the short axis cross-sectional image. For example, as shown in fig. 10C, a dashed window 803 in the central cross-sectional image 801 from volume 800 may select a particular finger. Then, for the short axis, the system will automatically extract the central cross-section of the three joints of the particular finger, distal interphalangeal joint (DIP) 804, proximal interphalangeal joint (PIP) 805, and Metacarpophalangeal (MCP) joint 806; for portrait, the system will automatically extract DIP 807, PIP 808 and MCP 809, which are then displayed to the clinician. Thus, by two 3D volume scans, one on the front of the hand and the other on the back of the hand, the clinician can obtain all the necessary finger joint cross-sectional images from multiple perspectives to analyze bone erosion of all 15 finger joints caused by rheumatoid arthritis. It is not necessary to scan each joint from multiple angles and save them separately for further analysis, which is very time consuming.

In the present invention, the 3D volume scan of the front and back of the hand takes only 5 minutes, rather than 40 minutes to 1.5 hours, which is required for conventional ultrasound scanning of all finger joints. Furthermore, 3D forms of the knuckles can be extracted from the 3D volume, which can present more information for bone erosion diagnosis and treatment. New image processing techniques, such as Artificial Intelligence (AI), can be used to analyze on the basis of 3D volumetric data that provides more information than conventional 2D images of the finger joints.

While the invention and embodiments of the invention have been described above schematically, this description is not intended to be limiting. The drawings show only one embodiment of the present invention, and the actual flow is not limited thereto. Therefore, those skilled in the art, having benefit of this disclosure, may devise any arrangement or implementation that, although not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope.

Claims

1. A disposable container for diagnosis of rheumatoid arthritis in a human finger joint, the disposable container comprising:

a top surface (101), a bottom surface (102), a first side surface (103) and a second side surface (104), the first side surface (103) being perpendicular to the second side surface (104);

wherein the top surface (101) is provided with an opening allowing a human hand to be placed therein;

the first side (103) is provided with fixing means (110) for fixing the container; and is also provided with

The second side (104) or bottom (102) is configured as a detection surface for ultrasonic detection.

2. Disposable container according to claim 1, wherein the securing means (110) comprises one or more lugs.

3. The disposable container of claim 1, wherein the disposable container is made of a material capable of achieving 1062.9-1540 m/s sound speed and 1.24-1.5 MRayl acoustic impedance.

4. The disposable container of claim 1, wherein the disposable container is made of a material selected from the group consisting of: silicone rubber, polyurethane rubber, or combinations thereof.

5. The disposable container of claim 1, wherein the disposable container is made of silicone rubber, the silicone rubber being one or more additives(EF) silicone rubber, the one or more additives being selected from glycerol (C3H 8O 3), commercial detergents or alumina.

6. A 3D ultrasound imaging system for diagnosis of rheumatoid arthritis in a human finger joint, the system comprising:

a disposable container (100) configured for receiving a human hand to be tested;

a linear array transducer (200) for full hand scanning;

-a mechanical motion control device (300) capable of gripping the linear array transducer (200) and moving it to complete a 3D volume scan of a human hand;

an imaging device (400) capable of forming a 2D ultrasound image and further reconstructing a 3D image for display and data analysis;

wherein the linear array transducer (200) and the mechanical motion control device (300) are connected with the imaging device (400), the linear array transducer (200) is held by the mechanical motion control device (300), and the surface of the linear array transducer (200) is coupled to be in close contact with the surface of the disposable container (100).

7. The 3D ultrasound imaging system of claim 6, wherein the material of the disposable container (100) has a sound speed of 1062.9-1540 m/s and an acoustic impedance of 1.24-1.5 MRayl.

8. The 3D ultrasound imaging system of claim 6, wherein the disposable container (100) is 13-25 cm in length, the disposable container (100) is 6-15 cm in width, and the disposable container (100) is 15-20 cm in height.

9. The 3D ultrasound imaging system of claim 6, wherein the linear array transducer (200) comprises:

an elongated acoustic stacking head (201) configured with more than 128 array elements to cover the entire width of a human hand; and

a transducer handle portion (202) configured with a high voltage multiplexer (210) and an inductor tuning unit (220) to enable a 128 channel system to drive the more than 128 element transducer.

10. The 3D ultrasound imaging system of claim 6, wherein the mechanical motion control device (300) comprises: a stepping motor (301), a gear unit (302), a linear rail (303) and a slider (304);

-the stepper motor (301) and the gear unit (302) are arranged on top of the linear track (303), the gear unit (302) being located below the stepper motor (301);

the slider (304) is arranged on the linear track (303), and a transducer mount (305) is mounted on the slider (304) such that the transducer mount (305) can move along the linear track (303) together with the slider (304).

11. The 3D ultrasound imaging system of claim 6, wherein the imaging device (400) comprises:

a transmitting unit for delivering one or more ultrasonic pulses to a human hand via the transducer;

a receiving unit for receiving and processing one or more ultrasound echoes from the human hand received by the transducer;

an artificial intelligence unit for bone erosion assessment; and

a display.

12. The 3D ultrasound imaging system of claim 6, further comprising a detection stage (500), wherein one or more frames (510) are mounted on the detection stage (500), the one or more frames (510) being configured for securing the disposable container (100).

13. The 3D ultrasound imaging system of claim 11, wherein the transmit unit comprises a transmit waveform generator that sends the generated waveforms to a transmit beamshaping unit for corresponding focusing delays and then to a pulse generator to generate transmit pulses that are then transmitted to the transducer through a transmit/receive T/R switch unit.

14. The 3D ultrasound imaging system according to claim 11, wherein the receiving unit includes a receiving front end that amplifies the electronic signal converted from the acoustic wave signal and forms a digital signal through an a/D converter, the converted multi-channel digital signal is dynamically focused in a receiving beam forming unit to form a receiving beam, and then the receiving beam sequentially passes through an intermediate processing unit and an image post-processing unit to form an ultrasound image usable for 3D reconstruction.

15. A method of 3D volume acquisition of a hand rheumatism, the method comprising:

1) Mounting a disposable container (100) on a test table (500), filling the disposable container (100) with a test liquid; and immersing a hand (600) within the disposable container (100);

2) Resetting the mechanical motion control device (300) to move the linear array transducer (200) to the starting position Z ₀ ；

3) Starting a 3D volume scan of the hand (600), the linear array transducer (200) from the starting position Z ₀ Moving to an end position Zstop, the linear array transducer (200) stopping at each Δz depth to acquire a 2D image;

4) After it has moved to the end position Zstop, the linear array transducer (200) is moved back to the start position Z ₀ ；

5) -flipping the hand (600) such that the other side of the hand (600) faces the linear array transducer (200);

6) By moving the linear array transducer (200) from the start position Z ₀ Moving to the end position Zstop and stopping at each Δz depth to acquire a 2D image to restart another 3D volume scan;

7) Based on the two volume scans, a 3D image is reconstructed by an imaging device (400) for diagnosis.

16. The method of 3D volume acquisition of a hand rheumatism of claim 15, wherein the Δz depth is set to 0.5mm-2mm.

17. The method of 3D volume acquisition of hand rheumatism of claim 15, wherein the detection fluid is water or saline.