CN117084786A

CN117084786A - Puncture navigation system, positioning holder and positioning puncture needle

Info

Publication number: CN117084786A
Application number: CN202311000582.9A
Authority: CN
Inventors: 文耀锋; 杨阳; 李湘民; 张旭
Original assignee: Shanghai Imt Medical Technology Co ltd
Current assignee: Shanghai Lanhui Medical Technology Co ltd
Priority date: 2023-08-09
Filing date: 2023-08-09
Publication date: 2023-11-21

Abstract

The invention discloses a puncture navigation system, which comprises: the positioning support is internally provided with at least three space markers; positioning a puncture needle, wherein an IMU positioner is arranged on the puncture needle; and the imaging unit is used for imaging the puncture part of the subject. The puncture navigation process of the system comprises the steps of enabling a tested person to lie on an inspection table, and placing the positioning support on a to-be-punctured part of the tested person; irradiating the puncture site with a detector of an imaging unit; the positioning puncture needle faces to the puncture site; and receiving the attitude angle of the IMU positioner on the positioning puncture needle, and combining the images acquired from the imaging unit to realize path planning and navigation of the puncture position.

Description

Puncture navigation system, positioning support and positioning puncture needle

Technical Field

The invention belongs to the technical field of clinical medicine, and particularly relates to a puncture navigation system, a positioning support and a positioning puncture needle.

Background

Biopsy (Biopsy) is abbreviated as "Biopsy". When a patient is hospitalized, a doctor may touch a tumor or find a tumor, nodule, or occupation by CT. However, it is not possible to determine whether the abnormality or tumor is benign or cancerous using physical examination, blood examination, urine examination, and image examination. At this time, a puncture biopsy is performed by surgery, and a living tissue sample or a cell sample is taken from the patient.

Thus, biopsy refers to taking a biopsy sample or a cell sample from a patient by surgery, incision, forceps, puncture, or the like, for pathological examination by a pathologist, as needed for diagnosis and treatment. Biopsies and pathology tests are often used to gain insight into whether a lesion/tumor is cancer, the type of cancer, the nature of the cancer, etc., and thus guide the patient through subsequent overall treatment protocols, including surgery, radiation therapy, and drug therapy.

The needle biopsy is performed after local anesthesia, and a doctor uses a lung puncture needle to guide the needle through the chest wall to a suspicious site through image guidance such as CT and obtain lung tissue. Such biopsies may also be referred to as closed, transthoracic biopsies or percutaneous biopsies. This process may take about half an hour to complete. The needle biopsy is classified into a needle biopsy (Fine Needle Aspiration Biopsy FNA) and a coarse needle/core needle biopsy (Core Needle Biopsy).

Disclosure of Invention

One of the embodiments of the present disclosure, a puncture navigation system, comprises,

the positioning support is internally provided with at least one space marker;

positioning a puncture needle, wherein an IMU positioner is arranged on the puncture needle;

and the imaging unit is used for imaging the puncture part of the subject.

Here, the IMU is known as inertial measurement unit, i.e. inertial measurement unit. The three-axis accelerometer and the three-axis gyroscope are used for detecting acceleration signals of an object on independent three axes of a carrier coordinate system, the gyroscope is used for detecting angular velocity signals of the carrier relative to a navigation coordinate system, and the gesture of the object can be calculated after the signals are processed.

When the imaging unit is a CT imaging unit, the spatial marker is used as a CT imaging marker. When the puncture part is positioned in the lung, the puncture navigation system of the embodiment of the disclosure is used for realizing the lung puncture positioning navigation process of registration under CT and angle correction based on IMU and CT imaging markers.

Drawings

The above, as well as additional purposes, features, and advantages of exemplary embodiments of the present invention will become readily apparent from the following detailed description when read in conjunction with the accompanying drawings. Several embodiments of the present invention are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which:

FIG. 1 is a schematic view of a positioning bracket according to one embodiment of the present invention.

FIG. 2 is a schematic diagram of a positioning bracket according to one embodiment of the present invention.

Fig. 3 is a partial enlarged view at a in fig. 2.

FIG. 4 is a schematic diagram of a puncture navigation system according to one embodiment of the present invention.

FIG. 5 is a flowchart of a puncture navigation method according to one embodiment of the present invention.

Fig. 6 is a graph illustrating exemplary puncture times according to one embodiment of the present invention.

10, a positioning support, 20, an operating table, 30, a subject,

11-a positioning puncture needle,

12-a square space marker,

13-a circular space marker,

14-triangular space markers.

Detailed Description

Traditional puncture biopsy must be determined through CT shooting for a plurality of times, so that a certain burden is caused to the body of a patient, and the maximum fault position determined through CT shooting for a plurality of times is not necessarily accurate. In addition, once the traditional puncture biopsy is carelessly deviated, a doctor cannot quickly know that the puncture needle must be confirmed through CT imaging for multiple times, and the risk of the puncture biopsy operation is increased.

In order to solve the above-mentioned problem, the present disclosure aims at accurately locating the spatial position of the affected part while reducing the loss to the patient's body, and timely reminding the doctor to turn the direction of the puncture needle through the IMU positioner under the condition that the puncture needle is offset.

The existing puncture biopsy process refers to the past CT image to determine the puncture position. The grid positioning ruler is attached to the surface of an affected part, a universal supporting frame is placed below the body of a patient, the head end of the supporting frame points to a puncture part, the positioning ruler is fixed at the affected part of the patient and used for puncturing the body surface, then CT scanning is carried out, the maximum fault part of lesions is determined according to CT pictures, a laser positioning lamp is turned on at the focus bed, and the intersection point of the laser positioning lamp and the grid positioning ruler is the skin needle insertion point. And determining the puncture angle, including the puncture needle penetration depth and the puncture target point, by measuring the included angle between the straight line formed by the needle penetration point and the affected part point and the perpendicular to the ground center. The guide device is tightly inserted into the supporting clamp, and the two-way angle is adjusted by using the guide device to clamp the puncture needle into the scanning fault. Then, a stepping needle is adopted, the first needle firstly enters the subcutaneous region within 2 cm, the direction of the puncture needle is observed, the second needle penetrates through the pleura to enter the lung until reaching the surface of an viscera, the direction of the puncture needle and the respiration of a patient are observed, the third needle is pricked above an affected part and rapidly enters lung tissues, and the fourth needle is pricked to be attached to the affected part.

In this process, spatial registration is involved. The ideal spatial registration means that the relative relation between the surgical instrument and the patient is determined in the operation through a three-dimensional positioning tracking system and is integrated with a preoperative CT model to be displayed together, so that the operation plan is effectively guided, and the operation is guided in real time. Meanwhile, the space registration can realize the visualization and real-time tracking of the surgical instrument. Existing punctures do not achieve the desired spatial registration.

Because of the existing needle biopsy procedures, including the following drawbacks:

1. the angle registration of the aspiration biopsy operation is very complex, and needs to be completed by doctors with years of image experience;

2. the skin can generate angle deviation when contacting the positioning ruler, so that the registration angle can be caused to generate deviation; 3. the space position of the affected part needs to be determined by a grid positioning ruler and a plurality of CT images, and a large amount of time is consumed;

4. calculating the space position of the affected part and the puncture angle, which need to be manually determined, and may have deviation;

5. when the position of the affected part is determined, the CT machine is started for a plurality of times, so that the health of a patient can be influenced;

6. the determination of the maximum tomographic part of the lesion is determined only by a plurality of CT pictures, and the determined position may not be the actual maximum tomographic part;

7. once the puncture needle is shifted, the doctor cannot quickly learn and can only calibrate through CT pictures.

In accordance with one or more embodiments, to address positioning navigation challenges in existing lancing procedures, the present disclosure proposes a lancing navigation system, as shown in fig. 4, comprising,

the positioning support is internally provided with at least 3 space markers, each space marker has different or same standard geometric shapes, is triangular, circular or square, and is convenient for space matching by the markers with three different geometric shapes;

positioning puncture needle, which is provided with IMU localizer and has locating point in the locating support, the locating point can be fixed, before the puncture navigation operation starts, the locating puncture needle is fixed in the locating support, because the mutual space positions of three space markers are known to be determined, thus the locating puncture needle also determines an initial space coordinate position in space;

and the CT imaging unit is used for imaging the puncture part of the subject, and the space marker can be used as a CT imaging marker.

Here, IMU is an english abbreviation for inertial navigation system, and the main elements are gyroscopes, accelerometers and magnetometers. The gyroscope can obtain the acceleration of each axis, the accelerometer can obtain the acceleration in the x, y and z directions, and the magnetometer can obtain the information of the surrounding magnetic field. The main work is to fuse the data of the three sensors to obtain more accurate attitude information. Notably, the IMU provides a relative positioning information that is used to measure the path traveled by the object relative to the origin.

The puncture navigation process of the system comprises the following steps,

allowing the subject to lie on the examination table, and placing the positioning support on the puncture site of the subject;

irradiating the puncture site with a detector of an imaging unit;

the positioning puncture needle is taken out from a positioning point in the positioning support and faces to the puncture site;

and receiving the attitude angle of the IMU positioner on the positioning puncture needle, and combining the images acquired from the imaging unit to realize path planning and navigation of the puncture position.

In the disclosed embodiment, as shown in fig. 1, 2 and 3, a positioning bracket device is designed to obtain an initial and fixed spatial coordinate. 3 markers are added into the positioning support, the function of the markers is to accurately and rapidly generate the space position of the affected part through a computer, the task amount of doctors can be reduced, and the 3 markers can be called as CT imaging markers. The 3 space markers, each having a different standard geometry, may be triangular, circular, square, respectively. Because the shapes are obviously different, different markers can be extracted by a simple feature extraction algorithm in image reconstruction and identification, and corresponding coordinates of the markers are positioned, so that the calculated amount is reduced, and the calculation speed is increased. Meanwhile, as the relative distance positions of the three markers are fixed and known, a navigation space reference system is established by the coordinates of the three markers and the surface determined by the three points, and in the reference system, the space path data of the positioning puncture needle with the IMU positioner is acquired, so that accurate positioning control and path planning of the puncture path can be realized. As also shown in fig. 1, the positioning tray may be designed in a concave shape for the comfort of the patient.

The material using the locating support is selected, the material which is not easy to deform is selected, and the locating support is placed below the body of a patient, so that the registration angle deviation which can be generated is reduced. The lung puncture needle is placed in the positioning support, and after the space initial position is determined, the lung puncture needle is taken out of the positioning support. Is not easy to be visualized in CT images. CT imaging markers have no impact on the physical health of the patient when determining the spatial location of the lesion. The ium angle instrument is combined with the puncture needle, the offset angle of the lung puncture needle aiming at the initial position is monitored in real time, and once the angle of the puncture needle deviation is larger than a set value, an alarm is given in time to remind a doctor of attention.

In the locating support, 3 CT imaging markers are fixed in the locating support, and meanwhile, a clamping groove is designed in the locating support and is specially used for placing and fixing a puncture needle with an IMU (inertial measurement Unit) locator. Since the 3 CT imaging markers are fixed in the positioning bracket, the doctor can know the positions of the 3 CT imaging markers in the real space. An IMU positioner is designed, and a clamp is arranged on the IMU positioner, so that the IMU positioner can be fixed on a puncture needle. After the puncture needle with the IMU positioner is inserted into the clamping groove of the positioning support, the puncture needle can be fixed in the positioning support, and then the positioning support is placed below the affected part.

The positioning support is made of a hard material, so that errors in measurement caused by deformation are prevented. Because the IMU positioner is fixed to the positioning bracket, the spatial location of the IMU positioner is also known. CT scanning is carried out on the affected part of the patient, and a doctor can know the real physical space position of the nodule, the angle required to be punctured and the puncture path through CT. Meanwhile, three markers can be shot by CT, and the markers are segmented by a deep learning method, so that the positions of 3 CT imaging markers in CT are obtained. The data processing computer of the puncture navigation system is connected to an image data output port of the CT machine, and can perform puncture registration by combining the received positioning track data of the IMU positioner for positioning the puncture needle after receiving CT image data comprising the actual spatial position data of 3 CT imaging markers. The process comprises the steps of establishing coordinates through 3 CT imaging markers, and initializing the IMU positioner to obtain the initial position of the IMU positioner. And meanwhile, the angle conversion required by the IMU positioner is calculated and is consistent with the planned puncture path, so that the puncture operation on a patient is guided. Before the puncturing process starts, the patient needs to shoot CT, the puncture needle with the IMU positioner is pulled out of the clamping groove of the positioning support, and the puncturing of the puncture site of the patient is started.

Specifically, the registration process herein includes the steps of:

1. a data processing computer of the puncture navigation system acquires CT data;

2. the CT image is automatically segmented by using a feature extraction algorithm, three markers are segmented, coordinates of the markers in an actual space are known, and the relative positions of the markers and the IMU are known, so that the position of the IMU in the CT image can be calculated;

identifying a tumor area of a patient through a manual or image identification algorithm, setting a puncture path, wherein the puncture path is linear, and setting coordinates of two points, a needle inlet point and a target point at the moment;

3. the coordinates of the two points, the needle-in point and the coordinates of the target point are transmitted back to the IMU positioner after being resolved;

4. at this point, the IMU knows the target angle and begins the angle reminder, where 2 thresholds, 2 ° and 5 °, respectively, may be set. If the needle is tilted within 2 degrees, the IMU positioner appears as a green light.

Since the three markers are fixed on the positioning support, it is more rapid to set different shapes for image recognition. In addition, the CT image also acquires the space data of the positioning support at the same time. In this way, spatial localization can be rapidly performed by the markers.

When the positioning puncture needle is started, the positioning puncture needle is fixed on the positioning support, and the initial spatial position is determined. The patient is in a supine or lateral position in a normal posture on the operating table for the puncture.

In accordance with one or more embodiments, a puncture procedure navigation system. The system includes a first processor configured to receive a signal,

the positioning support is internally provided with at least three space markers;

and the imaging unit is used for imaging the puncture part of the subject.

The positioning puncture needle is provided with a positioning point in the positioning support.

The puncture navigation process of the system comprises the following steps,

irradiating the puncture site with a detector of an imaging unit;

the positioning puncture needle is started from the positioning point to the puncture site;

After the puncture operation starts, the IMU continuously transmits data to a system navigation data processing computer, a computer program continuously analyzes the data of the IMU, then the data is transformed to a coordinate system of a real human body, and the current angle and the current position are tracked in real time and matched with a preset path. The accumulated error generated by the IMU is eliminated by filtering and other methods. The puncture navigation system can prompt a path planned by CT in reality by arranging the reminding device. Turning on laser positioning lamp at focus bed, and determining the position of puncture point by CT imaging paper and CT machine positioning cursor. The position of the puncture needle is also displayed in the CT image space, the system reconstructs a three-dimensional coordinate space according to CT data, and the puncture needle is also synchronously displayed in the space. The CT machine is a system re-imaging unit device, that is, the navigation data processing computer may also be connected to other types of human body image data scanning devices, including MRI devices, or other devices capable of acquiring human body internal image data in real time. CT imaging paper, also known as CT locating paper, developing tape, is used for percutaneous puncture location under CT guidance. The positioning paper is provided with small squares for positioning, and can be used for interventional puncture drainage, biopsy positioning and paratumor ablation positioning. Accurate positioning and clear image, and is suitable for interventional departments, zhong Liu departments, respiratory departments, orthopedics, pain departments and the like.

Here, 2 thresholds, 2 ° and 5 °, respectively, may be set. If the angle of inclination of the puncture needle is within 2 degrees, the IMU positioner displays a green light. If the offset angle is 2 to 5 degrees, the IMU locator blinks a yellow light and sounds an alarm. If the deviation angle is more than 5 degrees, a red light flashes to sound an alarm. Then, a stepping needle is adopted, the first needle firstly enters the subcutaneous region within 2 cm, the direction of the puncture needle is observed, the second needle penetrates through the pleura to enter the lung until reaching the surface of an viscera, the direction of the puncture needle and the respiration of a patient are observed, the third needle is pricked above an affected part and rapidly enters lung tissues, and the fourth needle is pricked to be attached to the affected part. During the puncturing process, a plurality of human body scanning CT image images can be acquired according to the requirement.

As shown in fig. 5, the puncture navigation process includes the steps of:

1. the IMU positioner is secured to the needle by a clamp, the IMU device of the needle is opened and the needle is inserted into the slot of the positioning bracket. Placing a positioning support, and enabling a patient to lie well;

CT scanning, determining the position of an affected part, dividing a CT imaging marker in a positioning support by using an algorithm, and performing spatial registration, wherein the relative position of the puncture needle and the CT imaging marker in the positioning support is known;

3. planning a puncture path by a doctor, and transmitting path data to an IMU device;

4. taking out the puncture needle from the clamping groove of the positioning support by a doctor, and performing puncture according to the lamplight prompt of the IMU device;

5. and (5) finishing the puncture.

Considering that the patient is always in a breathing state, the deviation of the spatial position can be caused, an IMU positioner can be additionally arranged on the patient, and the puncture part can be accurately positioned by correcting the breathing movement deviation of the patient. That is, a second IMU positioner or piezoresistive respiration sensor device may be added to the body to monitor changes in the body, either for the lungs or to prevent movement of the body.

Taking the lung as an example, as shown in fig. 6, firstly, the respiratory state (mainly, the fluctuation of the human body) during CT is determined, and then, the fluctuation state of the human body at the current moment is judged according to the IMU or the piezoresistive respiratory sensor device. When the proper area is reached, the lamp of the IMU puncture needle is displayed green, otherwise, other colors are displayed. The time interval represented by each time t in fig. 6 is a puncturable time.

According to the technical scheme, the space orientation of the affected part can be measured more accurately and rapidly, and the doctor is prompted by the IMU positioner prompt lamp to insert the puncture needle at a deviating angle, so that the puncture needle and the puncture-simulating part are attached accurately.

In the navigation system disclosed by the disclosure, the lung puncture needle is placed in the positioning support, after the determination of the space initial position is carried out, the lung puncture needle is taken out from the positioning support, 3 CT image markers are placed in the positioning support, a CT scanner or other types of real-time or non-real-time human body internal image equipment is used for collecting human body image data, and the human body image data is uploaded to a computer. The space position of the affected part is accurately determined by a computer, an IMU positioner is additionally arranged on the puncture needle, the offset angle of the puncture needle aiming at the initial position is monitored in real time, the puncture needle is divided into three ranges, and if the inclination angle of the puncture needle is within 2 degrees, the IMU positioner displays a green light. If the offset angle is 2 to 5 degrees, the IMU locator blinks a yellow light and sounds an alarm. If the deviation angle is more than 5 degrees, a red light flashes to sound an alarm.

Compared with the traditional method, the method disclosed by the invention is more accurate and has real-time performance, because the method for determining the spatial position of the affected part by using the CT imaging markers is quicker than the traditional method for determining the spatial position of the affected part according to a plurality of CT pictures. In conventional needle biopsy procedures, once the deflection of the needle occurs, it must be found and calibrated through multiple shots of the CT, but in this project the deflection can be quickly found using the IMU positioner so that the physician can find and calibrate in time.

It should be understood that, in the embodiment of the present invention, the term "and/or" is merely an association relationship describing the association object, which means that three relationships may exist. For example, a and/or B may represent: a exists alone, A and B exist together, and B exists alone. In addition, the character "/" herein generally indicates that the front and rear associated objects are an "or" relationship.

While the invention has been described with reference to certain preferred embodiments, it will be understood by those skilled in the art that various changes and substitutions of equivalents may be made and equivalents will be apparent to those skilled in the art without departing from the scope of the invention. Therefore, the protection scope of the invention is subject to the protection scope of the claims.

Claims

1. A puncture navigation system, characterized in that the system includes,

A positioning bracket, which is equipped with at least three spatial markers;

Position the puncture needle, which is provided with a first IMU locator;

The imaging unit is used to image the puncture site of the subject.

2. The puncture navigation system according to claim 1, wherein the positioning puncture needle has a positioning point in the positioning holder.

3. The puncture navigation system according to claim 2, characterized in that the puncture navigation process of the system includes:

Make the subject lie on the examination table, and place the positioning bracket on the subject's intended puncture site;

Illuminating the intended puncture site with a detector of the imaging unit;

Take the positioning puncture needle out from the positioning point and face the intended puncture site;

The attitude angle of the first IMU locator on the positioning puncture needle is received and combined with the image obtained from the imaging unit to realize path planning and navigation of the puncture position.

4. The puncture navigation system according to claim 3, characterized in that a second IMU locator is provided on the patient.

5. The puncture navigation system according to claim 1, characterized in that the system further includes a positioning light source for imaging and illuminating the intended puncture site,

Preferably, the imaging unit is a CT imaging unit.

6. The puncture navigation system according to claim 1, characterized in that the spatial landmark has a standard geometric shape,

Preferably, each spatial annotation has a different standard geometric shape.

7. The puncture navigation system according to claim 1, wherein the positioning bracket is provided with a slot, and the positioning puncture needle is placed in the slot.

8. A positioning bracket, characterized in that at least one spatial marker is provided in the positioning bracket, and the positioning bracket is used in the puncture navigation process. The positioning bracket is used in the following manner:

Illuminating the intended puncture site with a detector of the imaging unit;

The positioning puncture needle is taken out from the positioning point in the positioning holder and faces the intended puncture site;

9. The positioning bracket according to claim 8, characterized in that the number of spatial markers provided in the positioning bracket is multiple, and each spatial marker has a different standard geometric shape.

10. A positioning puncture needle, characterized in that the puncture needle is provided with an IMU for use in the puncture navigation system as claimed in claim 1.