WO2018214807A1

WO2018214807A1 - Removal method and apparatus for prostate puncture biopsy

Info

Publication number: WO2018214807A1
Application number: PCT/CN2018/087396
Authority: WO
Inventors: 叶慧
Original assignee: 北京龙慧珩医疗科技发展有限公司
Priority date: 2017-05-26
Filing date: 2018-05-17
Publication date: 2018-11-29
Also published as: CN107049371A; CN107049371B

Abstract

Disclosed are a removal method and apparatus capable of accurately operating a prostate puncture needle to carry out a biopsy. The traditional sextant biopsy is improved, i.e. improving equally dividing a whole prostate into six parts (the top, middle and bottom, and left and right sides of a prostate) before into only selecting a point to puncture in a region of interest. A clear and stereoscopic prostate lesion region can be completely provided to a doctor by means of preoperative image information. By means of adding an angle adjustment indication dial assisting apparatus, and computing, on the basis of preoperative planning, a needle point position, a planned route and a required puncture rotation angle, an improved puncture kit (9) can realize an accurate rotation operation, has higher precision and high individual specificity, and realizes accurate puncturing.

Description

Method and device for removing prostate biopsy biopsy

Technical field

The invention belongs to the field of medical instruments, and particularly relates to a local puncture method for prostate lesion tissue and a calculation method for the spatial position of the preoperative puncture needle.

Background technique

Prostate cancer is one of the most common cancers in the male population, and its mortality rate ranks second in non-skin cancer. Currently, the most popular prostate cancer screening method is serum prostate specific antigen screening, followed by six or more biopsies performed in real-time 2D transrectal ultrasound guidance. As part of this procedure, the prostate is typically divided into six equal volume regions. One or more biopsies are taken from each of these six regions in a systematic, but essentially non-directional manner. This procedure is called a sextant biopsy.

Because the sextant biopsy is low cost and relatively simple compared to other methods of detecting prostate cancer, it is widely used. However, the sextant biopsy has shown a severe false negative rate and may be inaccurate with regard to the true location of the biopsy. The results of the sextant biopsy are usually reported using the original standard map of the prostate, and the pathologist manually annotates the biopsy results on the original standard map of the prostate. This picture is intrinsically inaccurate because the pathologist who annotated does not know the real part of the biopsy. Transrectal ultrasound (TRUS)-guided systemic biopsy seems to solve the above technical problems. Because of its real-time performance, imaging without radiation, low cost and simple operation, it has become an important indicator for the diagnosis and diagnosis of prostate cancer. However, ultrasound imaging is fast, although it can be imaged in real time during surgery. However, due to the limited resolution of the ultrasound image, the discrimination between soft tissues in the image is not high. Although the position of the sampling catheter can be tracked in real time, the lesion cannot be imaged. Accurate positioning of the tissue results in a pure ultrasound-based sampling method that is not sensitive to cancer detection, only 60% to 85%.

Summary of the invention

The object of the present invention is to provide an improved structure of a puncture kit for prostate puncture and a calculation method of the spatial position of the preoperative puncture needle, so that the intraoperative rotary puncture needle becomes possible, and the operation angle prompt is more accurate, and a A personalized calculation method for the spatial position of the preoperative puncture needle to achieve accurate biopsy operation of the sextant. The method is mainly directed to the following technical problems existing in the prior art:

(1) The angle of the rotation operation is not accurate

Because the rotation angle is perceived by the tail that is coplanar with the needle tip, the rotation operation is not quantified. With the advent of the precision surgery era, quantitative operation instructions are required, so the surgical kit with precise scale is required. Be inevitable.

(2) The location of the sextant biopsy is completely based on experience

Because prostate interventional surgery is performed under 2D transrectal ultrasound guidance, only the prostate tissue contour can be seen without soft tissue. It is not sensitive to chronic prostatitis, prostatic hypertrophy, and early prostate cancer, so the sextant biopsy usually The average sample was taken from the top, middle and bottom of the prostate, and the left and right sides, and the representative samples were taken out. This random biopsy was predicted without accurately grasping the cancer location, and the high detection rate of cancer could not be guaranteed. Most cancers occur in the top region of the prostate. Although the biopsy is guided by the TURS, the needle may not reach the target area accurately. Only the doctor's skill and experience locate the needle, and it is impossible to accurately determine whether it is accurate.

The invention provides a method for the doctor to accurately operate the prostate puncture needle for biopsy and to calculate the spatial position of the preoperative needle. Through the improvement of the traditional sextant biopsy, the six parts of the prostate (the top, the middle and the bottom of the prostate, the left and the right sides) are improved in the past to select only the puncture of the region of interest, and the preoperative image information is completely Can provide the doctor with a clear, three-dimensional prostate lesion area, by adding an angle adjustment indicator dial assist device, and based on the preoperative planning to calculate the needle point position, the planning path and the required puncture rotation angle, so that the improvement The rear puncture kit enables precise rotation, high precision, and high individual specificity for precise puncture.

The technical solution of the present invention is:

A method comprising the steps of:

Inserting the puncture kit into a cavity in the body of the subject, the puncture set having an outer sheath, a puncture needle embedded in the outer sheath, and a hose, the outer edge of the outer sheath being connected to the first edge a position sensor having a handle tail end for the operator to hold and a remote front end contacting the examined portion; a contact force sensor at the remote front end portion, a transmitter, a receiver, and an ultrasound at the remote front end portion a transducer, and a second position sensor located at a rear side of the remote front end;

Operating the puncture needle into contact with a target detection point located in a wall of the chamber;

Establishing a desired contact force between the front end of the puncture needle distal front end and the target exit pin point in response to the reading of the contact force sensor;

Adjusting the puncture needle handle end space attitude according to the desired contact force until the desired first target injecting point is reached, and the examined tissue A1 is taken out through the hose;

Continue to adjust the spatial attitude of the end of the puncture needle handle to reach the pre-planned second, third, fourth, fifth, and sixth target insertion points; and take out the examined tissue A2, A3, A4, A5 through the hose , A6.

Further, the outer edge of the outer end of the outer sheath is further connected with an angle indicating dial, wherein the angle indicates that the dial is arranged counterclockwise, and the direction of the zero scale in the dial coincides with the sagittal axis of the human coordinate system.

Further, including:

Puncture point delineation, pre-acquisition of the medical imaging modality of the subject before surgery, path planning operation according to the imaging modality, and

The iterative threshold segmentation combined with morphological operation is used to segment the image of the detected part. The target feature morphology is extracted by the double threshold method in the segmented part of the segment, and then the surface rendering method is used for 3D visualization. Finally, the visual image is imported into 3D. The Slicer selects the first target entry point to the sixth target entry point based on the spatial anatomical positional relationship of the target feature form, thereby taking out the examined tissue A2, A3, A4, A5, A6.

Further, including

The medical imaging modality is one of the following, medical resonance (MR) imaging; computed tomography (CT) imaging; positron emission tomography (PET) imaging; or single photon emission computed tomography (SPECT) imaging.

Further, including the calculation of the calibration of the ultrasound image and the tracking system coordinate system,

In the first step, the medical imaging modal device has a custom coordinate system, which is recorded as the tracking system coordinate system C _{T in the method} , according to the voxel position parameter and the voxel size parameter in the DICOM file of the medical imaging modal image. The layer spacing parameter obtains the coordinate information of the reference point;

In the second step, the calibration container is filled with water or a coupling agent, and the puncture kit is placed on the fixing bracket, attached to one side of the container and fixed, and the ultrasonic image in the calibration container is collected in real time, and the second position sensor is recorded at this time. Conversion matrix T2;

In the third step, the metal probe locator is fixed on the probe clamping bracket, and the spatial position of the metal probe locator is moved. When a bright spot appears on the ultrasonic image, the movement stops, and the metal probe locator is fixed, and the metal probe is fixed. The needle tip is located in the ultrasound imaging area, and the coordinate P _{i of the} metal probe locator in the tracking system coordinate system C _T is recorded, and the coordinate I _i of the bright spot on the ultrasonic image coordinate system Cus is recorded on the ultrasonic image;

In the fourth step, the above operation is repeated n times to obtain a point set P _i (i=1, 2, . . . , n) in the tracking system coordinate system C _T , and the coordinates of the n points are all different, and are obtained with the n Point set I _i (i = 1, 2, ..., n) in the ultrasound image coordinate system Cus corresponding to the points; by the coordinate relationship, P _i = T2 · T1 · I _i , where P _i , I _i , T2 As known, T1 is pending.

Further, including

Let the transformation matrix T=T2·T1 between the US coordinate system (Cus) and the tracking system coordinate system (C _T ), then Pi=T·Ii; solve T using one of the following rigid point set registration methods, ICP (Iterative Closest) Points) algorithm, CPR (coherent point drift) algorithm, RP (robust point match) algorithm; after T is found, T1=(T2)-1·T.

As an embodiment of the present invention, there is also provided an apparatus, comprising: a puncture kit, a moving unit, a calibration container, and an information processing unit,

The puncture set has an outer sheath, a puncture needle and a hose embedded in the outer sheath, and an outer edge of the outer end of the outer sheath is connected to the first position sensor, and the puncture needle has a handle end end for the operator to hold And a remote front end contacting the examined portion; a contact force sensor at the remote front end portion, a transmitter at the remote front end portion, a receiver and an ultrasonic transducer, and a second side at a rear side of the remote front end portion position sensor;

Establishing, in response to the reading of the contact force sensor, a processor that establishes a desired contact force between the front end of the puncture needle distal front end and the target exit pin point;

An information processing unit that establishes an ultrasound image in response to the processor and the ultrasound transducer echo signal,

The moving unit moves the holder in real time in a three-dimensional direction;

The calibration container is a container that is open at the top.

Further, including

The outer edge of the outer end of the outer sheath is further connected with an angle indicating dial, the angle indicating that the dial is arranged counterclockwise, and the direction of the 0 scale in the dial coincides with the sagittal axis of the human coordinate system.

Further, including

The metal probe locator is composed of a handle, a needle and a positioning sensor, and the tracking system can display the real-time coordinates of the positioning sensor in the tracking system coordinate system in real time.

Further, including

The moving unit is composed of a base and a plurality of rods and a gripper. The rods are connected by a sliding rail, and the slidable and fixed gripper clamps the metal probe locator and can be moved to the target position and fixed. To keep the metal probe positioner down vertical.

DRAWINGS

The drawings described herein are intended to provide a further understanding of the invention, and are intended to be a part of the invention. In the drawing:

Figure 1 is a schematic diagram of a six-point sampling of the present invention.

2 is a schematic view of the schematic device of the angle dial of the present invention.

3 is a flow chart of a calibration scheme for an ultrasound image and tracking system coordinate system calibration according to the present invention.

4 is a US and tracking system coordinate system calibration apparatus of the present invention.

detailed description

The invention will be described in detail below with reference to the drawings in conjunction with the embodiments.

The invention mainly includes two aspects:

One is that the puncture kit structure is improved so that the rotation angle is accurately indicated during the operation; the other is to provide a personalized calculation method of the rotation angle.

1) Puncture kit structure improvement

Analysis of surgical procedures:

During the operation, the patient lies flat, the interventional physician passes the rectal puncture kit through the rectum into the prostate, and the ultrasound enters the prostate from the prostate side through the rectal wall, prostate, and rectal interface. In order to ensure the penetration of the ultrasonic signal, the working frequency is usually At around 6.5MHz, because the preoperative doctor has obtained the position of the lesion in the medical imaging modal device, the interventional doctor selects the region of interest for the needle by experience, and divides the traditional whole prostate into six parts (the top of the prostate, The middle and bottom, left and right sides are improved to select punctures only for the lesions of the above-mentioned regions of interest, and select the points in the upper-lower, left-right, anterior-posterior directions of the diseased tissue, as shown in Fig. 1. Because the rectum and the prostate are disconnected organs, the puncture needle can only be performed in the rectum, and the puncture kit can only move up and down the rectum. Therefore, if it is necessary to reduce the number of puncture needles entering the prostate and the depth as much as possible, the puncture needs to be performed. The needle advances in the direction of adjustment, that is, the tail end of the hand-held puncture needle handle rotates around the axis of the handle itself, so that The puncture needle achieves six-point sampling by in and out and rotation in the case of a needle insertion to the diseased tissue.

Puncture kit improvements:

To assist the physician in operation, the puncture needle handle end of the puncture kit contains a position sensor that provides a signal to a processor located in the console. The processor can perform several processing functions as described below, introducing a contact force sensor and a position sensor in the puncture kit, and an angle indicating dial on the outer edge of the outer end of the outer sheath of the puncture kit. The angle dial design is shown in Figure 2: the direction of the 0 scale in the dial coincides with the sagittal axis of the human coordinate system; the direction of the angle increase is counterclockwise; the hole in the center is the reserved hole for nesting in the puncture kit On the outer sheath. Establish the spatial position of the examined site before the operation, and establish the desired contact force between the front end of the distal end of the puncture needle and the target needle point according to the reading of the contact force sensor, usually the different parts of the test (eg prostate, The rectal, uterus, etc. have different stress values. For personalized surgical navigation, an experienced doctor will establish the relationship between the force value and the spatial position in advance as an aid, and the outer sheath with the dial will be fixed during the operation. The puncture needle and the hose are embedded in the outer sheath and enter and exit the rectum or rotate. The arrow at the end of the puncture needle is left outside the outer sheath, and the real-time reading operation is performed by reading the arrow on the indication of the dial and the force parameter given by the processor. Rotation angle.

2) Calculation of personalized ultrasound image and tracking system coordinate system calibration

The matching ultrasonic image and tracking system coordinate system calibration calculation scheme flow chart is shown in Figure 3:

In the second step, the calibration container (4) is filled with water or a coupling agent, and the puncture kit (9) is placed on the fixing bracket (11), attached to one side of the container (4) and fixed, and the calibration container is collected in real time (4). The ultrasonic image (6) inside, recording the conversion matrix T2 given by the second position sensor (10) at this time;

In the third step, the metal probe positioner 5 (composed of the handle 5-1 and the needle 5-2) is fixed on the probe holding bracket, and the spatial position of the metal probe positioner (5) is moved when the ultrasonic image appears. When the bright spot is stopped, the movement is stopped. At this time, the metal probe positioner is fixed, and the metal probe tip (5-2) is located in the ultrasonic imaging area, and the metal probe positioner (5) is recorded in the tracking system coordinate system C _T at this time. Coordinate (7) P _i , and record the coordinates (8) I _i of the bright spot on the ultrasonic image coordinate system Cus on the ultrasonic image; in the fourth step, repeat the above operation n times to obtain the point set in the tracking system coordinate system C _T P _i (i = 1, 2, ..., n), the coordinates of the n points are all different, and the point set I _i in the ultrasonic image coordinate system Cus corresponding to the n points is obtained (i = 1, 2) ,...,n); From the coordinate relationship, P _i =T2·T1·I _i , where P _i , I _i , T2 are known, and T1 is to be sought.

As shown in Fig. 4, the purpose of the probe holding bracket (1) is to hold the metal probe positioner (5) and to move the metal probe positioner (5) to the target position and fix it. The probe clamping bracket is composed of a base and a bracket rod (1), a crossbar (2), and a longitudinal rod (3). The bracket rod (1), the crossbar (2), and the longitudinal rod (3) are connected by a slide rail. , can be slid and fixed. A clamp is mounted on the longitudinal rod (3) to hold the shank 5-1 of the metal probe positioner (5) so that the needle 5-2 remains vertically downward.

The above description is only the preferred embodiment of the present invention, and is not intended to limit the present invention, and various modifications and changes can be made to the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and scope of the present invention are intended to be included within the scope of the present invention.

Claims

A method comprising the steps of:

Inserting the puncture kit into a cavity in the body of the subject, the puncture set having an outer sheath, a puncture needle embedded in the outer sheath, and a hose, the outer edge of the outer sheath being connected to the first edge a position sensor having a handle tail end for the operator to hold and a remote front end contacting the examined portion; a contact force sensor at the remote front end portion, a transmitter, a receiver, and an ultrasound at the remote front end portion a transducer, and a second position sensor located at a rear side of the remote front end;

Operating the puncture needle into contact with a target detection point located in a wall of the chamber;

Establishing a desired contact force between the front end of the puncture needle distal front end and the target exit pin point in response to the reading of the contact force sensor;

Adjusting the puncture needle handle end space attitude according to the desired contact force until the desired first target injecting point is reached, and the examined tissue A1 is taken out through the hose;

Continue to adjust the spatial attitude of the end of the puncture needle handle to reach the pre-planned second, third, fourth, fifth, and sixth target insertion points; and take out the examined tissue A2, A3, A4, A5 through the hose , A6.
The method according to claim 1, wherein the outer edge of the outer end of the outer sheath is further connected with an angle indicating dial, the angle indicating that the dial is arranged counterclockwise, and the direction of the zero scale in the dial is related to the human body. The sagittal axes of the coordinate system coincide.
The method of claim 2 including:

Puncture point delineation, pre-acquisition of the medical imaging modality of the subject before surgery, path planning operation according to the imaging modality, and

The iterative threshold segmentation combined with morphological operation is used to segment the image of the detected part. The target feature morphology is extracted by the double threshold method in the segmented part of the segment, and then the surface rendering method is used for 3D visualization. Finally, the visual image is imported into 3D. The Slicer selects the first target entry point to the sixth target entry point based on the spatial anatomical positional relationship of the target feature form, thereby taking out the examined tissue A2, A3, A4, A5, A6.
The method of claim 3 including

The medical imaging modality is one of the following, medical resonance (MR) imaging; computed tomography (CT) imaging; positron emission tomography (PET) imaging; or single photon emission computed tomography (SPECT) imaging.
The method of claim 4 including the calculation of the calibration of the ultrasound image and the tracking system coordinate system,

In the first step, the medical imaging modal device has a custom coordinate system, which is recorded as the tracking system coordinate system C T in the method , according to the voxel position parameter and the voxel size parameter in the DICOM file of the medical imaging modal image. The layer spacing parameter obtains the coordinate information of the reference point;

In the second step, the calibration container is filled with water or a coupling agent, and the puncture kit is placed on the fixing bracket, attached to one side of the container and fixed, and the ultrasonic image in the calibration container is collected in real time, and the second position sensor is recorded at this time. Conversion matrix T2;

In the third step, the metal probe locator is fixed on the probe clamping bracket, and the spatial position of the metal probe locator is moved. When a bright spot appears on the ultrasonic image, the movement stops, and the metal probe locator is fixed, and the metal probe is fixed. The needle tip is located in the ultrasound imaging area, and the coordinate P i of the metal probe locator in the tracking system coordinate system C T is recorded, and the coordinate I i of the bright spot on the ultrasonic image coordinate system Cus is recorded on the ultrasonic image;

In the fourth step, the above operation is repeated n times to obtain a point set P i (i=1, 2, . . . , n) in the tracking system coordinate system C T , and the coordinates of the n points are all different, and are obtained with the n Point set I i (i = 1, 2, ..., n) in the ultrasound image coordinate system Cus corresponding to the points; by the coordinate relationship, P i = T2 · T1 · I i , where P i , I i , T2 As known, T1 is pending.
The method of claim 5 including

Let the transformation matrix T=T2·T1 between the US coordinate system (Cus) and the tracking system coordinate system (C T ), then Pi=T·Ii; solve T using one of the following rigid point set registration methods, ICP (Iterative Closest) Points) algorithm, CPR (coherent point drift) algorithm, RP (robust point match) algorithm; after T is found, T1=(T2)-1·T.
An apparatus comprising: a puncture kit, a mobile unit, a calibration container, and an information processing unit,

The puncture set has an outer sheath, a puncture needle and a hose embedded in the outer sheath, and an outer edge of the outer end of the outer sheath is connected to the first position sensor, and the puncture needle has a handle end end for the operator to hold And a remote front end contacting the examined portion; a contact force sensor at the remote front end portion, a transmitter at the remote front end portion, a receiver and an ultrasonic transducer, and a second side at a rear side of the remote front end portion position sensor;

Establishing, in response to the reading of the contact force sensor, a processor that establishes a desired contact force between the front end of the puncture needle distal front end and the target exit pin point;

An information processing unit that establishes an ultrasound image in response to the processor and the ultrasound transducer echo signal,

The moving unit moves the holder in real time in a three-dimensional direction;

The calibration container is a container that is open at the top.
The device of claim 7 including

The outer edge of the outer end of the outer sheath is further connected with an angle indicating dial, the angle indicating that the dial is arranged counterclockwise, and the direction of the 0 scale in the dial coincides with the sagittal axis of the human coordinate system.
The device of claim 8 including

The metal probe locator is composed of a handle, a needle and a positioning sensor, and the tracking system can display the real-time coordinates of the positioning sensor in the tracking system coordinate system in real time.
The device of claim 9 further comprising

The moving unit is composed of a base and a plurality of rods and a gripper. The rods are connected by a sliding rail, and the slidable and fixed gripper clamps the metal probe locator and can be moved to the target position and fixed. To keep the metal probe positioner down vertical.