Real-time ultrasound guidance for puncture with automatic needle tip tracking and early warning device

Abstract

This invention, entitled "Real-time Ultrasonic Guidance and Automatic Needle Tip Tracking and Early Warning Device for Puncture," relates to the field of medical device technology. It solves the technical problem of deviations in the ultrasound guidance path, position, needle insertion path, and needle tip position in existing technologies. Key technical points include: acquiring the coordinates and angle of the puncture needle on the puncture instrument; acquiring the coordinates of the ultrasound probe in the ultrasound device; generating an ultrasound image containing the puncture needle's trajectory and the puncture site using a navigation system; analyzing hyperecho points in the ultrasound image using an image analysis module to determine the needle tip position; obtaining the needle tip movement distance based on the real-time needle tip position; obtaining the puncture depth based on real-time monitoring information from the first and second electromagnetic positioning sensors; and determining whether the puncture is abnormal based on the needle tip position, needle tip movement distance, and puncture depth.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a real-time ultrasound-guided, automatic needle tip tracking and early warning device for puncture. Background Technology

[0002] Internal jugular vein puncture and subclavian vein puncture are commonly used intravenous catheterization techniques in clinical practice. The internal jugular vein is punctured in the neck under ultrasound guidance or anatomical localization for purposes such as rapid fluid resuscitation, monitoring central venous pressure, and infusion of hypertonic drugs.

[0003] Ultrasound-guided puncture is an operation that uses real-time ultrasound imaging technology to assist doctors in accurately inserting a puncture needle into the target area of ​​the human body. Its core advantages are real-time dynamic monitoring, precise positioning, minimal trauma, and fewer complications. It requires combination of preoperative assessment, standardized intraoperative operation, and postoperative monitoring to ensure safety.

[0004] During the puncture procedure, both the ultrasound probe and the puncture needle require coordinated operation of both hands. For inexperienced medical staff, this can be difficult and prone to complications. This can lead to deviations between the ultrasound-guided path and position, the needle insertion path, and the needle tip position, making it easy for the needle tip to come into contact with nearby dangerous tissue structures. Summary of the Invention

[0005] The purpose of this invention is to provide: A real-time ultrasound guidance and automatic needle tip tracking and early warning device for puncture solves the technical problem that there are certain deviations in the ultrasound guidance path, position, needle insertion path, and needle tip position in the prior art.

[0006] Terminology Explanation: Unless otherwise defined, all technical terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which this subject matter pertains. Unless otherwise stated, all patents, patent inventions, and disclosures cited throughout this document are incorporated herein by reference in their entirety. Where multiple definitions exist for terms herein, the definitions provided in this chapter shall prevail.

[0007] It should be understood that the above brief description and the following detailed description are exemplary and for illustrative purposes only, and do not limit the subject matter of the invention in any way. In this invention, the singular is used in conjunction with the plural unless otherwise specifically stated. It should also be noted that, unless otherwise stated, the use of “or” or “or” means “and / or”. Furthermore, the use of the term “comprising” and other forms such as “including,” “containing,” and “contains” are not limiting.

[0008] Unless specifically defined herein, the use of various commercially available products herein employs standard techniques. For example, they may be implemented using the manufacturer's instructions for use, or in accordance with methods known in the art or the description of this invention. The techniques and methods described herein can generally be implemented according to conventional methods well known in the art, based on the descriptions in the various general and more specific documents cited and discussed in this specification.

[0009] The terms “optional / arbitrary” or “optionally / arbitrarily” mean that the event or situation described below may or may not occur, including both the occurrence and non-occurrence of the event or situation.

[0010] A real-time ultrasound-guided needle tip automatic tracking and early warning device for puncture, comprising: A puncture instrument, comprising a handle and a puncture needle disposed on the handle; a first electromagnetic positioning sensor is disposed on the handle for monitoring the position of the handle; a second electromagnetic positioning sensor is slidably disposed on the puncture needle for monitoring the coordinates and angle of the position of the second electromagnetic positioning sensor on the puncture needle. An ultrasound device, comprising an ultrasound probe and an ultrasound imaging module; the ultrasound probe is used to acquire ultrasound detection information of the site to be punctured, and the ultrasound imaging module generates a real-time ultrasound image based on the ultrasound detection information; a third electromagnetic positioning sensor is provided on the ultrasound probe for real-time monitoring of the position of the ultrasound probe. The navigation system acquires information monitored by the first electromagnetic positioning sensor, the second electromagnetic positioning sensor, and the third electromagnetic positioning sensor, and generates an ultrasound image that includes the actual running trajectory of the puncture needle and the fused ultrasound images of the puncture site. The ultrasound device also includes an image analysis module, which is used to analyze strong echo points in the ultrasound image and determine the needle tip position. The needle tip movement distance is obtained based on the real-time needle tip position, and the puncture depth of the puncture needle is obtained based on the real-time monitoring information of the first electromagnetic positioning sensor and the second electromagnetic positioning sensor; the puncture is judged to be abnormal based on the needle tip position, needle tip movement distance and puncture depth. If the puncture is abnormal, a visual warning will be issued.

[0011] Furthermore, the image analysis module includes: In the initial state, the coordinate transformation unit sets the second electromagnetic sensor at the needle tip position. Based on the needle tip coordinate information obtained by the second electromagnetic positioning sensor and combined with the ultrasound probe coordinate information obtained by the third electromagnetic positioning sensor, the coordinate transformation unit determines the position of the puncture point in the ultrasound image. The strong echo analysis unit, based on ultrasound images, determines the strong echo point that forms from the puncture point after the puncture begins; this is the needle tip position.

[0012] Furthermore, the coordinate transformation unit determines the predetermined puncture trajectory based on the coordinate position of the handheld part obtained by the first electromagnetic positioning sensor and the position of the puncture point, and divides the predetermined puncture trajectory into multiple discrete points to obtain the coordinate information of the discrete points in the ultrasound image. At the same time, the coordinate transformation unit obtains the real-time coordinate information of the needle tip position, calculates the real-time coordinate information of the needle tip position and the coordinate information of each discrete point, obtains the distance between the current needle tip position and each discrete point, and obtains multiple distance values. The minimum value among multiple distance values ​​is obtained. If the minimum value exceeds the deviation threshold, it is determined that the needle tip has deviated, and a visual warning is issued.

[0013] Furthermore, the real-time coordinate information of the needle tip position is established in a coordinate system with the puncture point as the origin, the predetermined puncture trajectory as the X-axis, and the direction perpendicular to the X-axis as the Y-axis, denoted as the puncture point coordinate system; the real-time coordinate value of the needle tip position is obtained in the puncture point coordinate system. The coordinate information of discrete points is the coordinate information obtained within the coordinate system of the puncture point.

[0014] Furthermore, the coordinate information of the needle tip position is obtained at a predetermined frequency, and the distance between the current needle tip position and the needle tip position at the previous moment is calculated starting from the puncture point and recorded as the needle tip change value. Based on the coordinate information of the handheld part obtained by the first electromagnetic positioning sensor at the current moment, and the coordinate information of the puncture point obtained by the second electromagnetic positioning sensor, the distance between the first electromagnetic positioning sensor and the second electromagnetic positioning sensor at the current moment is calculated and recorded as the first distance value. Based on the coordinate information of the handheld part obtained by the first electromagnetic positioning sensor at the previous moment, and the coordinate information of the puncture point obtained by the second electromagnetic positioning sensor, the distance between the first electromagnetic positioning sensor and the second electromagnetic positioning sensor at the previous moment is calculated and recorded as the second distance value. Based on the first distance value and the second distance value, the change in puncture depth is obtained; The changes in needle tip value and puncture depth value are compared to determine whether the puncture needle has bent.

[0015] Furthermore, if the needle tip change value is less than the puncture depth change value, and the difference between the depth change value and the needle tip change value is greater than the judgment threshold, then the puncture needle bends, and a visual warning is issued.

[0016] Furthermore, the real-time ultrasound guidance and automatic needle tip tracking and early warning device for puncture also includes: Display module, the display module being used to display ultrasound images; The early warning unit provides a visual warning based on the judgment result of the puncture abnormality.

[0017] Furthermore, when the puncture abnormality is determined to be needle tip deviation, a warning box with the deviation prompt appears on the display module; When the puncture needle is bent, a warning message box with the word "bent" appears on the display module.

[0018] Furthermore, the navigation system includes: The coordinate system transformation unit is used to transform the coordinate information obtained by the first electromagnetic positioning sensor, the second electromagnetic positioning sensor, and the third electromagnetic positioning sensor into the same coordinate system, thereby realizing the fusion of the actual running trajectory of the puncture needle and the ultrasonic image of the puncture site.

[0019] Compared with the prior art, the present invention has at least the following beneficial effects: 1. This invention can monitor the puncture trajectory in real time, determine whether the puncture has deviated, and thus accurately control the puncture path to avoid the puncture needle from touching dangerous structures.

[0020] 2. The present invention can determine whether the puncture needle is bent in real time. Compared with the prior art that determines the form of bending by image, the present invention can determine the three-dimensional bending, not just the planar bending shown in the image. Attached Figure Description

[0021] Figure 1 This is a structural block diagram of the present invention. Detailed Implementation

[0022] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0023] Example 1 This embodiment provides a real-time ultrasound-guided, automatic needle tip tracking and early warning device for puncture, such as... Figure 1 As shown, Figure 1 This is only intended to illustrate the relationships between the various modules and their components, and does not limit the actual design location of each component. The device includes a puncture instrument, an ultrasound device, a navigation system, a display module, and an early warning unit. The puncture instrument includes a handle and a puncture needle disposed on the handle; specifically, the puncture instrument is a commonly used puncture instrument in the prior art, and the connection method between the puncture needle and the handle, the specific structure of the handle, and the specific structure of the puncture needle are all in the prior art.

[0024] A first electromagnetic positioning sensor is provided on the handheld part to monitor the position of the handheld part, which is recorded according to a world coordinate system or a local coordinate system. A second electromagnetic positioning sensor is slidably disposed on the puncture needle to monitor the coordinates and angle of the position of the second electromagnetic positioning sensor on the puncture needle; wherein the slidable disposal can be achieved by placing the second electromagnetic positioning sensor on a slip ring formed by a circular ring, the slip ring passing through the outside of the puncture needle.

[0025] The ultrasound device includes an ultrasound probe and an ultrasound imaging module. The ultrasound probe is used to acquire ultrasound detection information of the puncture site, such as the internal jugular vein or subclavian vein. For this type of puncture, the tissue at the puncture site is complex, and there are dangerous structures such as arteries and pleura around the target blood vessel. Therefore, it is necessary to use ultrasound equipment to understand the position of the needle tip in real time to avoid touching dangerous structures and causing complications.

[0026] The ultrasonic imaging module generates real-time ultrasonic images based on ultrasonic detection information; a third electromagnetic positioning sensor is installed on the ultrasonic probe to monitor the position of the ultrasonic probe in real time.

[0027] The navigation system acquires information monitored by the first, second, and third electromagnetic positioning sensors, and generates an ultrasound image that fuses the actual trajectory of the puncture needle with ultrasound images of the puncture site. The navigation system includes a coordinate system transformation unit, used to transform the coordinate information acquired by the first, second, and third electromagnetic positioning sensors into the same coordinate system, thereby achieving the fusion of the actual trajectory of the puncture needle and the ultrasound image of the puncture site.

[0028] The ultrasound device also includes an image analysis module, which is used to analyze strong echo points in the ultrasound image and determine the needle tip position; the needle tip position is the location of the tip of the puncture needle.

[0029] The needle tip movement distance is obtained based on the real-time needle tip position, and the puncture depth is obtained based on the real-time monitoring information of the first electromagnetic positioning sensor and the second electromagnetic positioning sensor. Based on the needle tip position, needle tip movement distance and puncture depth, it is determined whether the puncture is abnormal. If the puncture is abnormal, a visual warning is issued.

[0030] The image analysis module includes a coordinate transformation unit and a strong echo analysis unit. The core function of the coordinate transformation unit is to establish a mapping relationship between the puncture point and the ultrasound image, obtaining the specific location of the puncture point in the ultrasound image. Initially, the second electromagnetic sensor is positioned at the needle tip; therefore, the coordinates obtained by the second electromagnetic sensor represent the needle tip position. When the needle tip is placed at the puncture point, the coordinates of the puncture point are obtained using the second electromagnetic sensor. Based on the needle tip coordinate information obtained by the second electromagnetic positioning sensor, and combined with the ultrasound probe coordinate information obtained by the third electromagnetic positioning sensor, the coordinate transformation unit determines the location of the puncture point in the ultrasound image.

[0031] The second electromagnetic positioning sensor acquires coordinate information at a frequency of no less than 100Hz to ensure the real-time nature and accuracy of the location information.

[0032] The coordinate system transformation unit of the navigation system incorporates a spatial coordinate mapping algorithm. This algorithm first synchronizes and calibrates the coordinate information acquired by the second and third electromagnetic positioning sensors, eliminating deviations caused by electromagnetic signal transmission delays and sensor installation errors. Then, it establishes a transformation model between pixel coordinates in the ultrasonic image and the spatial coordinate system, which can be either the world coordinate system or a local coordinate system. Simultaneously, by using the coordinate information of the puncture point in the world coordinate system or the same local coordinate system, the pixel coordinates of the puncture point in the ultrasonic image can be obtained, thus determining the location of the puncture point in the ultrasonic image.

[0033] To better display the puncture point location, a red crosshair can be superimposed on the display module's screen.

[0034] The strong echo analysis unit, based on ultrasound images, identifies the strong echo points that begin forming from the puncture point after the puncture begins; this is the needle tip position. The strong echo analysis unit is primarily used for real-time dynamic tracking of the needle tip position during the puncture process, compensating for dynamic deviations in the initial coordinate positioning during the puncture procedure and providing real-time feedback to the physician.

[0035] The methods for determining strong echo points can include pixel analysis or brightness comparison. The ultrasound probe continuously acquires ultrasound images of the area to be punctured, forming multiple consecutive frames. These frames are preprocessed, including noise reduction and contrast enhancement. The grayscale value of each pixel in each image is obtained, and areas with smaller grayscale values ​​(smaller grayscale values ​​indicate higher brightness) are identified. Combined with the puncture point location, the strong echo point where the puncture point begins to move is selected as the needle tip location.

[0036] This embodiment mainly has two functions, the first being a deviation warning function: The coordinate transformation unit determines the predetermined puncture trajectory based on the coordinate position of the handheld part and the position of the puncture point obtained by the first electromagnetic positioning sensor, and divides the predetermined puncture trajectory into multiple discrete points to obtain the coordinate information of the discrete points in the ultrasound image. The predetermined puncture trajectory is usually a straight line. In this embodiment, the predetermined puncture trajectory is set as follows: a straight line extending from the hand-held part and passing through the puncture point. The endpoint position is determined according to the predetermined puncture depth, and the predetermined puncture trajectory is finally formed.

[0037] At the same time, the coordinate transformation unit obtains the real-time coordinate information of the needle tip position, calculates the real-time coordinate information of the needle tip position and the coordinate information of each discrete point, obtains the distance between the current needle tip position and each discrete point, and obtains multiple distance values. The minimum value among multiple distance values ​​is obtained. If the minimum value exceeds the deviation threshold, it is determined that the needle tip has deviated, and a visual warning is issued.

[0038] The deviation threshold is selected based on actual needs. The larger the deviation threshold, the higher the puncture accuracy, and vice versa. For example, the deviation threshold can be set to 0.2mm.

[0039] The real-time coordinate information of the needle tip position is established in a coordinate system with the puncture point as the origin, the predetermined puncture trajectory as the X-axis, and the direction perpendicular to the X-axis as the Y-axis, denoted as the puncture point coordinate system; the real-time coordinate value of the needle tip position is obtained in the puncture point coordinate system; the coordinate information of discrete points is the coordinate information obtained in the puncture point coordinate system.

[0040] Secondly, it features a needle bending warning function: The real-time coordinate information of the needle tip position is obtained at a predetermined frequency. Starting from the puncture point, the distance between the current needle tip position and the needle tip position at the previous moment is calculated and recorded as the needle tip change value. Based on the coordinate information of the handheld part obtained by the first electromagnetic positioning sensor at the current moment, and the coordinate information of the puncture point obtained by the second electromagnetic positioning sensor, the distance between the first electromagnetic positioning sensor and the second electromagnetic positioning sensor at the current moment is calculated and recorded as the first distance value. Based on the coordinate information of the handheld part obtained by the first electromagnetic positioning sensor at the previous moment, and the coordinate information of the puncture point obtained by the second electromagnetic positioning sensor, the distance between the first electromagnetic positioning sensor and the second electromagnetic positioning sensor at the previous moment is calculated and recorded as the second distance value. The puncture depth variation value is obtained based on the first distance value and the second distance value; the puncture depth variation value is obtained by subtracting the first distance value from the second distance value.

[0041] The changes in needle tip value and puncture depth value are compared to determine whether the puncture needle has bent.

[0042] Specifically, if the change in needle tip value is less than the change in puncture depth value, and the difference between the change in depth value and the change in needle tip value is greater than the judgment threshold, then the puncture needle bends, triggering a visual warning. The judgment threshold is also set according to actual needs; a larger value results in more precise puncture accuracy; for example, it can be 0.05mm.

[0043] In addition, the display module includes a display screen for displaying ultrasound images; The early warning unit provides visual warnings based on the judgment of abnormal puncture.

[0044] When the puncture abnormality is judged as needle tip deviation, a warning box with the deviation prompt appears on the display module; When the puncture needle is bent, a warning message box with the word "bent" appears on the display module.

[0045] In summary, the present invention has the following beneficial effects: 1. It can monitor the puncture trajectory in real time, determine whether the puncture has deviated, and then accurately control the puncture path to avoid the puncture needle from touching dangerous structures.

[0046] 2. It can determine whether the puncture needle is bent in real time. Compared with the existing technology that judges the bending form by image, the present invention can judge the three-dimensional bending, not just the planar bending shown in the image.

[0047] The above specific embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to examples, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the protection scope of the present invention.

Claims

1. A real-time ultrasound-guided, automatic needle tip tracking and early warning device for puncture, characterized in that, include: A puncture instrument, comprising a handle and a puncture needle disposed on the handle; a first electromagnetic positioning sensor is disposed on the handle for monitoring the position of the handle; a second electromagnetic positioning sensor is slidably disposed on the puncture needle for monitoring the coordinates and angle of the position of the second electromagnetic positioning sensor on the puncture needle. An ultrasound device, comprising an ultrasound probe and an ultrasound imaging module; the ultrasound probe is used to acquire ultrasound detection information of the site to be punctured, and the ultrasound imaging module generates a real-time ultrasound image based on the ultrasound detection information; a third electromagnetic positioning sensor is provided on the ultrasound probe for real-time monitoring of the position of the ultrasound probe. The navigation system acquires information monitored by the first electromagnetic positioning sensor, the second electromagnetic positioning sensor, and the third electromagnetic positioning sensor, and generates an ultrasound image that includes the actual running trajectory of the puncture needle and the fused ultrasound images of the puncture site. The ultrasound device also includes an image analysis module, which is used to analyze strong echo points in the ultrasound image and determine the needle tip position. The needle tip movement distance is obtained based on the real-time needle tip position, and the puncture depth of the puncture needle is obtained based on the real-time monitoring information of the first electromagnetic positioning sensor and the second electromagnetic positioning sensor; the puncture is judged to be abnormal based on the needle tip position, needle tip movement distance and puncture depth. If the puncture is abnormal, a visual warning will be issued.

2. The real-time ultrasound guidance and automatic needle tip tracking and early warning device according to claim 1, characterized in that, The image analysis module includes: In the initial state, the coordinate transformation unit sets the second electromagnetic positioning sensor at the needle tip position. Based on the needle tip coordinate information obtained by the second electromagnetic positioning sensor and combined with the coordinate information of the ultrasound probe obtained by the third electromagnetic positioning sensor, the coordinate transformation unit determines the position of the puncture point in the ultrasound image. The strong echo analysis unit, based on ultrasound images, determines the strong echo point that forms from the puncture point after the puncture begins; this is the needle tip position.

3. The real-time ultrasound guidance and automatic needle tip tracking and early warning device according to claim 2, characterized in that, The coordinate transformation unit determines the predetermined puncture trajectory based on the coordinate position of the handheld part and the position of the puncture point obtained by the first electromagnetic positioning sensor, and divides the predetermined puncture trajectory into multiple discrete points to obtain the coordinate information of the discrete points in the ultrasound image. At the same time, the coordinate transformation unit obtains the real-time coordinate information of the needle tip position, calculates the real-time coordinate information of the needle tip position and the coordinate information of each discrete point, obtains the distance between the current needle tip position and each discrete point, and obtains multiple distance values. The minimum value among multiple distance values ​​is obtained. If the minimum value exceeds the deviation threshold, it is determined that the needle tip has deviated, and a visual warning is issued.

4. The real-time ultrasound guidance and automatic needle tip tracking and early warning device according to claim 3, characterized in that, The real-time coordinate information of the needle tip position is established in a coordinate system with the puncture point as the origin, the predetermined puncture trajectory as the X-axis, and the direction perpendicular to the X-axis as the Y-axis, which is denoted as the puncture point coordinate system; the real-time coordinate value of the needle tip position is obtained in the puncture point coordinate system. The coordinate information of discrete points is the coordinate information obtained within the coordinate system of the puncture point.

5. The real-time ultrasound guidance and automatic needle tip tracking and early warning device according to claim 3, characterized in that, The coordinate information of the needle tip position is obtained at a predetermined frequency. Starting from the puncture point, the distance between the current needle tip position and the needle tip position at the previous moment is calculated and recorded as the needle tip change value. Based on the coordinate information of the handheld part obtained by the first electromagnetic positioning sensor at the current moment, and the coordinate information of the puncture point obtained by the second electromagnetic positioning sensor, the distance between the first electromagnetic positioning sensor and the second electromagnetic positioning sensor at the current moment is calculated and recorded as the first distance value. Based on the coordinate information of the handheld part obtained by the first electromagnetic positioning sensor at the previous moment, and the coordinate information of the puncture point obtained by the second electromagnetic positioning sensor, the distance between the first electromagnetic positioning sensor and the second electromagnetic positioning sensor at the previous moment is calculated and recorded as the second distance value. Based on the first distance value and the second distance value, the change in puncture depth is obtained; The changes in needle tip value and puncture depth value are compared to determine whether the puncture needle has bent.

6. The real-time ultrasound-guided automatic needle tip tracking and early warning device according to claim 5, characterized in that, If the change value of the needle tip is less than the change value of the puncture depth, and the difference between the change value of the depth and the change value of the needle tip is greater than the judgment threshold, then the puncture needle bends, and a visual warning is issued.

7. The real-time ultrasound-guided automatic needle tip tracking and early warning device according to claim 1, characterized in that, The real-time ultrasound guidance and automatic needle tip tracking and early warning device for puncture also includes: Display module, the display module being used to display ultrasound images; The early warning unit provides a visual warning based on the judgment result of the puncture abnormality.

8. The real-time ultrasound-guided automatic needle tip tracking and early warning device according to claim 7, characterized in that, When the puncture abnormality is judged as needle tip deviation, a warning box with the deviation prompt appears on the display module; When the puncture needle is bent, a warning message box with the word "bent" appears on the display module.

9. The real-time ultrasound-guided automatic needle tip tracking and early warning device according to claim 1, characterized in that, The navigation system includes: The coordinate system transformation unit is used to transform the coordinate information obtained by the first electromagnetic positioning sensor, the second electromagnetic positioning sensor, and the third electromagnetic positioning sensor into the same coordinate system, thereby realizing the fusion of the actual running trajectory of the puncture needle and the ultrasonic image of the puncture site.

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