WO2016060308A1

WO2016060308A1 - Needle insertion type robot apparatus for interventional surgery

Info

Publication number: WO2016060308A1
Application number: PCT/KR2014/009839
Authority: WO
Inventors: 박창민; 김남국
Original assignee: 서울대학교병원; 울산대학교산학협력단
Priority date: 2014-10-17
Filing date: 2014-10-20
Publication date: 2016-04-21
Also published as: KR101862133B1; KR20160046012A

Abstract

The present disclosure relates to a needle insertion type robot apparatus for interventional surgery, comprising: as a computer for incorporating operation plan information into an operating room image, a computer which incorporates operation plan information into an operating room image, the operation plan information comprising a target point on the border of a heterogeneous surgical target and an insertion route of a needle-type medical instrument; as a robot having a needle-type medical instrument, a robot which operates according to the direction of the computer so that the needle-type medical instrument follows the insertion route; and as a user interface (UI) which interworks with the computer and displays the border of the surgical target using the operating room image into which the operation plan information has been incorporated, a UI which displays an estimated position that the tip of the needle-type medical instrument will reach with respect to the target point when the robot operates according to an operation plan.

Description

Needle Insertion Intervention Robot Device

The present disclosure relates generally to a needle implantable interventional robotic device, and more particularly to a needle implantable interventional robotic device that effectively performs biopsy of a target point on a border of a heterogeneous lesion. will be.

This section provides background information related to the present disclosure which is not necessarily prior art.

Medical imaging-based biopsy is an interventional procedure that minimizes damage to the surrounding normal tissue and extracts the samples necessary for the pathological diagnosis of abnormal lesions, including post-peritoneal, adrenal, pancreatic and lymph nodes. It is widely applied to various organs in the abdominal cavity, lungs, mediastinum, spine and extremities. Medical image-based biopsy enables the detection of small lesions by using high resolution images to delicately localize the lesion area in three dimensions and view biopsy needles that have entered the tissue. .

In a procedure performing a medical imaging based biopsy, the CT or C-arm fluoroscopy device and its images can be used to guide the insertion path of the biopsy needle, for example in the planning of the insertion path. The path of insertion of the biopsy needle can be accurately planned by determining the entry angle and insertion point of the biopsy needle at. When the patient enters the procedure room and the operation begins, the image acquisition device (eg, Fluoroscopy device, CBCT device) placed in the procedure room is aligned with the planned path, i.e., the orientation in which the biopsy needle will be inserted.

A navigation view is used to accurately guide the biopsy needle during the biopsy process. For example, in a navigation view such as Surgeon's Eye View shown in FIG. 1, when the insertion point is inserted into the biopsy needle, the center point of the target is shown, and the biopsy needle is based on the insertion point. Looks like this point In this navigation view, the target is displayed as a point and a circle is drawn around the point. Here you can plan to stick a few millimeters at any angle depending on the planning of the insertion path.

Recently, however, it has been accepted that the tumor is not homogeneous but that the biological properties of the tumor (eg DNA mutation, malignancy) are different for each site within the tumor. Whether it is collected is an important issue in the diagnosis of the tumor, the prediction of the therapeutic effect of the tumor and the estimation of the patient's prognosis. For example, an active tumor cell is located at the edge of the tumor, and the inside of the tumor is necrotic, and there are no tumor cells (necrosis). When a biopsy needle is inserted at the center of the tumor, false negative Incorrectly diagnosed errors may occur. Therefore, the operator may intentionally stab the periphery of the tumor sensibly by experience while looking at the floroscopy image to biopsy this heterogeneous tumor. However, it is not easy for the operator to stick the center of the tumor as planned, and it can be technically very difficult to accurately biopsy tumor cells that are distributed over relatively difficult tumor edges.

In addition, heterogeneous tumors are biopsied with multi-spots that perform biopsy at a plurality of target points, and maps representing the properties of tissues according to positions in the tumor are matched by matching the biopsy location with the characteristics of the sample. It is very important medically, and it is more difficult to biopsy multiple spots based on the operator's experience.

FIG. 2 is a diagram illustrating an example of a navigation screen for an ablation procedure disclosed in U.S. Patent Application Publication No. 2013/0317363. FIG. 2 illustrates a target treatment area 138b of an ablation procedure and an expected treatment range when the procedure is performed. 138a). There is no consideration of heterogeneity of the target and no disclosure of an effective guide method for reaching the medical instrument at the edge of the target.

This will be described later in the section on Embodiments of the Invention.

This section provides a general summary of the disclosure and is not a comprehensive disclosure of its full scope or all, provided that this is a summary of the disclosure. of its features).

According to one aspect of the present disclosure (According to one aspect of the present disclosure), a needle implantable interventional robot apparatus, comprising: a computer integrating surgical planning information into an operating room image; a heterogeneous surgical target A computer incorporating surgical planning information, including a target point on the border of the device and insertion path of the needle-shaped medical instrument, into the operating room image; A robot having a needle-shaped medical tool, comprising: a robot operating according to a computer instruction such that the needle-shaped medical tool follows an insertion path; And a user interface (UI) showing the edge of the affected area using an operating room image in which the operation plan information is integrated with a computer. The operation of the end of the needle-shaped medical tool for the target point when the robot operates according to the operation plan. There is provided a needle-inserted interventional robot device comprising a; user interface showing the expected arrival position.

This will be described later in the section on Embodiments of the Invention.

1 is a view showing an example of Surgeon's Eye View,

2 is a view showing an example of a navigation screen for the ablation procedure disclosed in US Patent Publication No. 2013/0317363;

3 is a view for explaining an example of the needle insertion interventional robot apparatus according to the present disclosure,

4 is a view illustrating an example of a method of dividing a tumor and generating a surgical plan in a preoperative image;

5 is a view illustrating an example of a surgical plan including a plurality of target points, an insertion path, and an insertion point of a biopsy at the edge of a tumor;

6 is a diagram illustrating an example of a preoperative image in which a tumor and an insertion path are visualized;

7 is a diagram illustrating an example of a method in which an operation plan is integrated into an operating room image;

8 is a view for explaining an example of the positioning means for grasping the relative position information of the patient and the biopsy needle;

9 illustrates an example of a user interface;

10 is a view for explaining an example of a robot equipped with a revolver type biopsy needle.

The present disclosure will now be described in detail with reference to the accompanying drawing (s).

3 is a view for explaining an example of the needle insertion intervention robot device according to the present disclosure, the needle insertion intervention robot device (hereinafter referred to as intervention intervention robot device) is a biopsy for reducing the radiation exposure, improving the accuracy of the procedure And therapeutic needle implantable imaging interventional robotic systems. The interventional robotic device can be used for biopsy and treatment of 1 cm-class lesions in the abdomen, chest, and the like. An example of a needle-type medical tool is a biopsy needle.

For example, the interventional robot device may include a computer 600 that processes or generates a medical image, a robot 100 that works in conjunction with the computer, and an estimated arrival position of the tip of the biopsy needle 111 at the edge of the tumor. It includes a user interface 500 for showing and guiding. The interventional robot device includes a master device 200 for controlling the robot 100 in real time in conjunction with the user interface 500, an image capturing device 300 for capturing the position of the biopsy needle 111 in the human body, and , The apparatus 100 for monitoring the position and posture of the robot 100, the patient 50, and peripheral devices, and the like.

4 is a diagram illustrating an example of a method of segmenting a tumor and generating a surgical plan in a preoperative image. The interventional robot device may be applied to biopsies of organs such as lungs, kidneys, liver, etc., and application to other parts of the organs is not excluded. In this example, the lungs are described.

As shown in FIG. 4, the preoperative image is thresholded on the lung of the patient to segment the lesion 10 (eg, a tumor) and generate a surgical plan. For example, after obtaining volumetric chest CT images (pulmonary images), the lung images are segmented to prepare a divided lung image. As a result of the segmentation, anatomical structures (eg, blood vessels, ribs, airways, lung boundaries, etc.) included in the lung image can be extracted into a three-dimensional set of voxels, and blood vessels, ribs, segmented from the lung image Anatomical structures, such as airways and the like, may be stored as a lung mask, a vessel mask, a rib mask, an airway mask, or the like. The tumor 10 is divided by a segmentation technique (eg, adaptive threshold) using a HU value appropriate for the tumor 10 as a threshold value. 4 shows an example of an axial cross section of a lung image in which the tumor 10 is divided.

The computer 600 is loaded with a preoperative image of the patient, and the operating room image and the preoperative image of the patient acquired at the procedure room are registered by the computer. As a result of the registration, a surgical plan including the

insertion paths

82 and 84, the insertion point 41, the target point on the tumor, and the like made using the preoperative image is transferred to the operating room image. This is further described below.

5 is a diagram illustrating an example of a surgical plan including a plurality of target points, an insertion path, and an insertion point of a biopsy at the edge of a tumor.

As described above, the tumor 10 may have active cancer cells at the edge 11 or the outer wall, and may have rotten water inside the tumor 10. Therefore, when the edge 11 and the inside of the tumor have different intensities in the image, and the thresholds are distinguished from the edges and the inside of the tumor 10, as shown in FIG. 5, the edge 11 and the inside of the tumor ( 15) are divided to separate. Alternatively, according to the metabolic characteristics of the tumor 10, the FDG-PET / CT image is used to distinguish between active and low metabolic sites with high intake of FDG and the like. Thresholding the standardized uptake value (SUV) allows the tumor 10 to be segmented as shown in FIG. 5. Alternatively, the entire tumor 10 may be divided and defined-divided around the tumor 10 using Morphological operators such as distance map or Eroding from the tumor 10 boundary.

The divided tumor 10 may be generated as a 3D image. Therefore, the cross section of the tumor 10 can be seen in the direction required by the image processing software, the tumor 10 is visualized to be distinguished from the surroundings, and the edge of the tumor 10 is distinguished from the interior of the tumor 10. Can be. For example, the tumor 10 can be viewed in representative directions, such as axial view, coronal view, and sagittal view, and a surgical plan can be created based on this. .

As shown in FIG. 5, a plurality of biopsy target points (eg, 21, 22, 23, 24, 26) are captured at the edge 11 of the tumor. As described above, the edge 11 of the tumor may be divided from the inside and the periphery by the division. The interior of the tumor 10 is a cell (necrosis) dead, the edge 11 may be active cancer cells are distributed. The number of target points may be determined at various positions in the tumor 10 as well as at the edge 11 as well as inside the tumor 10. The tumor 10 may be heterogeneous, and the DNA mutation may be different according to the location, and thus the effect may be different when a particular drug or treatment is performed according to the location in the tumor 10. Therefore, if you do only one biopsy, there is a problem that other places live and relapse. Depending on the size of the tumor 10, the thickness of the edge 11 can be estimated approximately statistically, for example, if the tumor 10 is as large as 2 centimeters, then the center of the tumor 10 is not biopsied or In addition to the biopsy of the center, a surgical plan is made to set a plurality of biopsy target points on the edge 11. If the biopsy needle 111 has a submillimeter accuracy, the surgical plan may be made to stab the edge 11 with an accuracy of 1 millimeter * 1 millimeter for a tumor 10 having a size of 20 millimeters wide. Can be.

A biopsy is preferable at a plurality of target points in the tumor 10, and then a map of the tumor 10 is made medically meaningful by matching the properties and positions of the samples. Each insertion path can be made to reach each target point, for example, an insertion path is created such that blood vessels or other structures that intersect the insertion path are minimal. Accordingly, the insertion point of the biopsy needle 111 is determined on the skin of the patient. The insertion point may be smaller than the number of target points. For example, after the biopsy needle 111 is stabbed, other target points may be biopsied by changing the direction without completely removing it from the lung.

FIG. 6 illustrates an example of a preoperative image in which a tumor and an insertion path are visualized, and an insertion path (eg, 82) is visualized in 3D between a real rib and a rib. The plurality of target points, insertion points, and insertion paths determined as described above are added to the preoperative image to generate a surgical plan. The preoperative image is a 3D image, and as shown in FIG. 6 through volume rendering, the surgical plan may be generated in 3D. The tumor 10 is divided from the periphery and is marked so that the edge 11 is distinguished. The insertion path is visualized in three dimensions, and a target point (eg, 21) is displayed at the edge 11 of the tumor.

Tumor 10 has little contrast and is hardly visible in fluoroscopy city, and tumor 10 is generally shown in a circular shape, but in this example, the tumor 10 is divided so that the edge of tumor 10 is distinguished in the preoperative image. , So that it appears on the operating room image.

Even if the edge 11 of the tumor is not clearly divided, if the tumor 10 and the periphery are clearly divided, the biopsy may be performed assuming a certain thickness as the edge 11 from the boundary between the tumor 10 and the periphery. have.

FIG. 7 is a view illustrating an example of a method of integrating a surgical plan into an operating room image. An operating room image is acquired at an operating room, and the preoperative image and the operating room image are matched to insert an operation path into the operating room image. The plan is transferred. As a method of registration between medical images, rigid registration and deformable registration methods and the like may be used.

The insertion path 82 may be modified through the user interface 500, and an inappropriate insertion path may be removed in consideration of breathing or movement. 7 (a) is an example of the pre-operative image, Figure 7 (b) is an image of the operation plan transfer image as the image of the operating room image and the pre-operative image is matched.

In order to more reliably confirm the target point on the 3D visualized insertion path 82 and the edge 11 of the tumor, the insertion path on a multiplanar reconstruction (MPR, axial view, coronal view, sagittal view) 82, the insertion point and the target point may be overlaid and displayed (the axial view is illustrated in FIG. 7).

As such, the biopsy needle 111 may be guided along the insertion path identified on the MPR to perform the procedure. For example, the final confirmed insertion path is transmitted to a robot or user interface (e.g. navigation device) or the like using TCP / IP or a dedicated communication protocol. The biopsy needle 111 may of course be a single needle type, but a plurality of revolver types (see FIG. 10) may be mounted on the robot in order to biopsy a multi-spot, and thus it may be more effective to biopsy each target point sequentially. On the other hand, to reduce the number of times to stab the lungs and remove the biopsy needle 111 from the lungs again, it is possible to stab other target points by changing the direction of the insertion path without removing the biopsy needle 111 and those shown in FIG.

8 is a view for explaining an example of the positioning means for grasping the relative position information of the patient and the biopsy needle.

Various methods may be used as the positioning means for determining the relative positional relationship between the patient 960 and the biopsy needle 912. For example, as shown in FIG. 8, the patient 960, the robot 911 with the biopsy needle 912, the infrared camera 991, the

infrared reflector assemblies

911, 913, 914, the monitor 920 and the computer ( 940 is provided. The infrared camera 991 detects the plurality of

infrared reflectors

911 and 914 indicating the position of the patient 960 and the plurality of infrared reflectors or infrared emitters 913 provided at the ends of the biopsy needle 912, thereby allowing the needle 912 and The location of the patient 960 can be identified. A computer 940 is provided for overall operation of the master console, and a monitor 920 is also provided. The computer 940 and the monitor 920 may correspond to the computer 600 and the user interface 500 described with reference to FIG. 3.

In the case of using the relative positional relationship between the patient 960 and the needle 912, the computer 940 also functions as a surgical navigation device. In accordance with the manipulation of the master 200 (see FIG. 1) operator, the biopsy needle 912 of the robot 911 is actuated by the computer 940. The infrared reflector assembly 911 is fixed to the patient 960 to indicate the position of the patient 960, the infrared reflector assembly 913 is fixed to the biopsy needle 912 to indicate the position of the biopsy needle 912, and the infrared reflector Assembly 914 is positioned on the chest of patient 960 to indicate patient movement, such as breathing, sneezing of the patient. As the position sensing means for positioning, an infrared camera and an infrared reflector are used, but a magnetic field can be used, and any means can be used as long as the position can be sensed. For example, it is possible to attach a magnetic sensor to the biopsy needle and track with the camera how far it moves.

The infrared reflector assembly 911 may be used to indicate the location information of the patient 960, may function as a reference position of the entire system, may be fixed to the patient 960, but may be fixed to the operating table, or the operating table. An additional infrared reflector assembly (not shown) may serve as a reference position. The location of the biopsy needle 912 relative to the patient 960 can be determined.

Unlike the above examples, referring to FIG. 3, an example in which the robot 100 itself knows a location is possible. For example, the robot 100 is holding the biopsy needle 111, the robot 100 itself can know its coordinates in the procedure. In addition, the robot 100 itself may detect how many millimeters the biopsy needle 111 moves. Therefore, the computer can calculate the orientation and position of the biopsy needle 111 in the space of the procedure image.

In addition, the computer may calculate the current position of the biopsy needle 111 by matching with the floroscopy city for acquiring the procedure image in a matched operating image space.

It is preferable in terms of accuracy and safety that the positioning means uses a plurality of methods to determine the positional relationship rather than using only one. The distance between the biopsy needle 111 and the target point of the edge 11 of the tumor can be calculated by the computer calculating the relative positional relationship between the patient and the biopsy needle 111 identified by the one or more locating means. Therefore, when poking with the insertion path, the insertion angle, the insertion point, and the insertion distance determined in the surgical plan, the expected arrival position of the tip of the biopsy needle 111 is calculated by the computer. The expected arrival location is displayed on the matched operating room image to inform the operator. This is further described below.

9 illustrates an example of a user interface, and a plurality of

screens

510, 520, 530, and 540 are displayed on the user interface 500. For example, there is a CT image (CT volume; for example, an image transmitted from a floroscopy) on the upper screen, and a mask showing various structures or lesions of the lung is displayed. In addition, there is a button for performing an operation plan and an information window for displaying procedure information or type.

The main screen 510 displays a matched operating room image displayed in 3D such that the edge 11 of the affected part is visually distinguished. In addition, MPR images (eg, 520, 530, 540) generated by the computer from the operating room image are displayed on the right side. For example, the tumor 10 having the edge 11 separated in the same direction as the axial view, the coronal view, and the sagittal view 530; In the insertion path 82, insertion point 41, and edge 11, the expected arrival positions of the biopsy needle tips (eg, 21, 22, 23, 24, 26) are indicated.

The relative position of the biopsy needle 111 and the patient 50 can be known in the same manner as described in FIG. 8, and the operating room image (eg, 510) visually displays the matched tumor 10 and simulates the tumor. Seat 11 appears. Therefore, the distance between the target point on the edge 11 of the tumor and the biopsy needle 111 and the expected arrival position (eg, 21, 22, 23, 24, 26) where it will be reached if stabbed to the projected depth at the currently aligned angle. The computer can calculate it. Thus, the computer can display the calculated estimated arrival position on the matched operating room image. Therefore, it is possible to visually know whether the target point and the expected arrival position (21, 22, 23, 24, 26) match. If there is a match, the operator instructs the computer 600 (see FIG. 3) via the master console and the biopsy needle 111 is inserted into the human body by the operation of the robot 100 linked to the computer 600. On the other hand, as described above, by re-taking the current operating room image, such as fluoroscopy, cone beam city, the position of the end of the biopsy needle 111 can be calculated in the operating room image space, the tumor 10 matched with this You can recheck if your goal is met by comparing the targets. If the expected arrival position and target point do not match, the surgical plan can be modified. For example, the screen displays the difference between the target point and the expected arrival position, and the computer can create an instruction to correct the position of the robot. Alternatively, the operator can instruct the computer by modifying the insertion path or depth.

Hereinafter, various embodiments of the present disclosure will be described.

(1) A needle implantable interventional robot device, comprising: a computer integrating surgical planning information into an operating room image, comprising: a target point and a needle point on the edge of a heterogeneous surgical target; A computer incorporating surgical planning information including an insertion path of a medical instrument into the operating room image; A robot having a needle-shaped medical tool, comprising: a robot operating according to a computer instruction such that the needle-shaped medical tool follows an insertion path; And a user interface (UI) showing the edge of the affected area using an operating room image in which the operation plan information is integrated with a computer. The operation of the end of the needle-shaped medical tool for the target point when the robot operates according to the operation plan is performed. And a user interface showing an expected arrival position.

(2) The surgical plan includes a plurality of target points on the edge of the lesion, wherein the computer matches the location of each target point in the lesion and each sample of the lesion obtained at each target point by a needle-shaped medical instrument. Needle insertion interventional robot device, characterized in that for storing information.

(3) the user interface includes: at least one screen showing a cross section of the affected part, the screen showing the edge of the affected part and the expected arrival position of the end of the needle-shaped medical tool; Device.

And (4) a positioning means for grasping relative position information of the affected part and the needle-type medical tool and providing the same to a computer.

(5) The needle inserted interventional robot device, characterized in that the computer compares the estimated arrival position of the target point with the tip of the needle-type medical instrument and displays the position change information of the robot for matching on the user interface when there is a mismatch.

(6) The at least one screen includes at least one of an axial view, a coronal view, and a sagittal view of the affected area, wherein the at least one screen includes an axial view, a coronal view, and a digital view. At least one of the views is a needle insertion interventional robot device, characterized in that the edge of the affected area, the expected arrival position of the end of the needle-shaped medical tool is displayed.

(7) the user interface includes: an additional screen showing a three-dimensional operating room image incorporating a surgical plan; an additional screen showing an edge of the affected part and an expected arrival position of the end of the needle-shaped medical tool; Needle insertion type interventional robot device, characterized in that.

(8) When the changed surgical plan is input through the user interface, the computer calculates the changed estimated arrival position, and the user interface displays the changed estimated arrival position on the screen and additional screens. Device.

(9) The locating means includes: a marker for marking the needle-shaped medical tool and the patient; And

Needle insertion interventional robot device comprising a; sensing device for detecting a marker.

(10) The needle-type medical instrument is a biopsy needle, the needle of the biopsy needle is a revolver type, a plurality of dogs mounted on the robot, the needle insertion interventional robot device, characterized in that to sequentially biopsy each target point.

According to one of the needle-inserted interventional robot device according to the present disclosure, it is possible to more accurately biopsy at the edge of the heterogeneous tumor, and to reduce the error or risk issued by the human biopsy.

According to another needle-insertion interventional robot device according to the present disclosure, it is more effective when the affected part is biopsyed with multi-spots.

According to another needle-insertion interventional robotic device according to the present disclosure, performing a biopsy on multiple target points and recording the sample in association with the location in the tumor to establish a drug or treatment plan according to the location in the tumor. To create a map.

Claims

In the needle insertion interventional robot device,

A computer that integrates surgical planning information into an operating room image, comprising: a surgical point information including a target point on an edge of a heterogeneous surgical target and an insertion path of a needle-shaped medical tool; Computer integrating to operating room image;

A robot having a needle-shaped medical tool, comprising: a robot operating according to a computer instruction such that the needle-shaped medical tool follows an insertion path; And

A user interface (UI) showing the edge of the affected area using operating room images integrated with computerized surgical planning information; predicting the end of the needle-shaped medical tool to the target point when the robot operates according to the surgical plan. And a user interface showing a location of arrival.
The method according to claim 1,

The surgical plan includes a plurality of target points on the edge of the lesion,

And the computer stores the affected part location-sample information for matching the location of each target point in the affected part and each sample of the affected part obtained at each target point by the needle-shaped medical instrument.
The method according to claim 1,

The user interface is:

At least one screen showing a cross-section of the affected area, including a screen showing the expected position of the edge of the affected area and the end of the needle-shaped medical instrument; needle inserted interventional robot device comprising a.
The method according to claim 1,

The needle insertion interventional robot device comprising a; means for locating the relative position information of the affected part and the needle-type medical tool to provide to the computer.
The method according to claim 1,

And the computer compares the predicted arrival position of the target point with the end of the needle-shaped medical tool, and displays the position change information of the robot for matching on the user interface when there is a mismatch.
The method according to claim 3,

The at least one screen includes at least one of an axial view, a coronal view, and a sagittal view of the affected part,

And at least one of the axial view, the coronal view, and the three-dimensional view indicate an edge of the affected part and an expected arrival position of the tip of the needle-shaped medical tool.
The method according to claim 3,

The user interface is:

An additional screen showing a three-dimensional operating room image incorporating a surgical plan; an additional screen showing an edge of the affected part and an expected location of the end of the needle-shaped medical tool; Surgical robotic device.
The method according to claim 7,

When the changed surgical plan is input through the user interface, the computer calculates the changed expected arrival position, and the user interface displays the changed expected arrival position on the screen and additional screens.
The method according to claim 4,

Positioning means are:

Markers to mark needle-like medical instruments and patients; And

Needle insertion interventional robot device comprising a; sensing device for detecting a marker.
The method according to claim 2,

The medical needle is a biopsy needle,

Biopsy needle is a revolver type is a plurality of dogs mounted on the robot, needle insertion interventional robot device, characterized in that to sequentially biopsy each target point.