WO2021199935A1

WO2021199935A1 - Medical care system

Info

Publication number: WO2021199935A1
Application number: PCT/JP2021/008974
Authority: WO
Inventors: 泰徳山下; 丸山　智司
Original assignee: テルモ株式会社
Priority date: 2020-03-30
Filing date: 2021-03-08
Publication date: 2021-10-07
Also published as: JPWO2021199935A1

Abstract

[Problem] To provide a medical care system that improves storage efficiency, such as storage for saving data, in a method for generating 3D image data of a hollow organ using a diagnostic imaging method such as IVUS. [Solution] A medical system 1 comprises: a first acquisition unit 100 capable of acquiring three-dimensional coordinates of a hollow organ of a subject; and a signal transmission/reception unit 245 which is inserted into the hollow organ of the subject and is capable of transmitting/receiving waves of a prescribed wavelength at the tip. The medical care system 1 also includes: a second acquisition unit 200 capable of generating two-dimensional data from signals acquired by the signal transmission/reception unit; a second storage unit 301b that stores the two-dimensional data generated by the second acquisition unit from the acquired signals; an input unit 301c capable of specifying a range of the two-dimensional data to be associated with the three-dimensional coordinates when the three-dimensional coordinates and the two-dimensional data are associated with each other; and a processor 301a that, on the basis of said range, identifies the two-dimensional data to be associated with the three-dimensional coordinates from among the two-dimensional data stored in the second storage unit.

Description

Medical system

This disclosure relates to the medical system.

In recent years, diagnostic imaging methods such as IVUS (Intravascular Ultrasound) and OCT (Optical Coherence Tomography) have been used as methods for obtaining tomographic images of luminal organs.

JP-A-2010-201077

It is possible to generate 3D image data in the long axis direction of the luminal organ from the tomographic image of the luminal organ acquired by IVUS, OCT, or the like. The present inventor is diligently studying a method of efficiently using a storage area such as a storage when generating 3D image data of a luminal organ from an image diagnosis method such as IVUS.

The present disclosure has been made in view of the above problems, and in a method of generating 3D image data of a luminal organ using a diagnostic imaging method such as IVUS, it is necessary to improve the storage efficiency of a storage or the like for storing data. With the goal.

Further, the medical system according to one aspect of the present disclosure includes a first acquisition unit, a second acquisition unit, a storage unit, an input unit, and a setting unit. The first acquisition unit is configured to be able to acquire the three-dimensional coordinates of the luminal organ of the subject. The second acquisition unit is provided with a transmission / reception unit that is inserted into the tract organ of the subject and can transmit / receive waves of a predetermined wavelength at the tip, and can generate two-dimensional data from the signal acquired by the transmission / reception unit. It is configured. The storage unit stores the two-dimensional data generated from the signal acquired by the second acquisition unit. The input unit is configured to be able to specify the range of the two-dimensional data associated with the three-dimensional coordinates when associating the three-dimensional coordinates with the two-dimensional data. The setting unit sets the amount of two-dimensional data of the luminal organ stored in the storage unit in association with the three-dimensional coordinates based on the above range.

Further, the medical system according to one aspect of the present disclosure includes a first acquisition unit, a second acquisition unit, a storage unit, an input unit, and a setting unit. The first acquisition unit is configured to be able to acquire the three-dimensional coordinates of the luminal organ of the subject. The second acquisition unit is provided with a transmission / reception unit that is inserted into the tract organ of the subject and can transmit / receive waves of a predetermined wavelength at the tip, and can generate two-dimensional data from the signal acquired by the transmission / reception unit. It is configured. The storage unit stores the two-dimensional data generated from the signal acquired by the second acquisition unit. The input unit is configured to be able to specify the range of the two-dimensional data associated with the three-dimensional coordinates when associating the three-dimensional coordinates with the two-dimensional data. The setting unit selects the two-dimensional data to be associated with the three-dimensional coordinates from the two-dimensional data stored in the storage unit based on the above range.

According to the above medical system, it is possible to improve the storage efficiency of a storage or the like for storing data in a method of generating 3D image data of a luminal organ using a diagnostic imaging method such as IVUS.

It is the schematic which shows the medical system which concerns on 1st Embodiment of this disclosure. It is a figure which shows the state before and after performing the pullback operation in the diagnostic imaging catheter which concerns on FIG. It is sectional drawing which shows the structure of the tip side of the diagnostic imaging catheter. It is sectional drawing which shows the structure of the proximal end side of the diagnostic imaging catheter. It is a figure which shows the position which generates the 2D data of a luminal organ. It is a figure which shows when the 2D data acquired from a blood vessel (a luminal organ) is selected. It is a flowchart which shows the 3D image data generation method which concerns on 1st Embodiment of this disclosure. It is a schematic diagram which shows the medical system which concerns on 2nd Embodiment of this disclosure. It is a flowchart which shows the 3D image data generation method which concerns on 2nd Embodiment of this disclosure. It is a figure which shows the case of selecting 2D data by machine learning when a plurality of 2D data are acquired at a certain position of a tract organ in order to generate 3D image data of a tract organ. It is a figure which shows the case of selecting 2D data by machine learning when a plurality of 2D data are acquired at a certain position of a tract organ in order to generate 3D image data of a tract organ.

(First Embodiment)
Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. The dimensional ratios in the drawings are exaggerated for convenience of explanation and may differ from the actual ratios. The medical system 1 according to the present embodiment is used in a percutaneous coronary intervention (PCI) used in treating a patient having a cardiovascular disease.

As shown in FIG. 1, the medical system 1 in the present disclosure includes a first acquisition unit 100, a second acquisition unit 200, an external device 300, and a main server 400. The details will be described below.

(1st acquisition department)
The first acquisition unit 100 is configured to be able to acquire the three-dimensional coordinates of the luminal organ of the subject. The first acquisition unit 100 includes an irradiation unit 110, a detection unit 120, a bed 130, a first storage unit 140, a processor 150, and an input / output unit 160.

The irradiation unit 110 is configured to be capable of irradiating radiation having a predetermined wavelength such as X-rays toward the sleeper 130. The irradiation unit 110 can be mounted on a gantry such as a known medical CT. The irradiation range of the radiation emitted from the irradiation unit 110 can be regulated by a diaphragm or the like.

The detection unit 120 receives the X-rays and the like irradiated from the irradiation unit 110. The detection unit 120 can include an image sensor such as CMOS. The detection unit 120 can be mounted on a known medical CT gantry or the like like the irradiation unit 110. The irradiation unit 110 and the detection unit 120 can be configured to rotate the gantry at a position where the sleeper 130 can be irradiated with X-rays or the like.

The sleeper 130 is arranged at a position where X-rays and the like from the irradiation unit 110 can be irradiated.

The first storage unit 140 includes a ROM, a RAM, an auxiliary storage unit, and the like. A program required for generating an X-ray image is stored in the ROM. The data acquired by the detection unit 120 is read into the RAM, and the image generated by the processor 150 is displayed on a display or the like (not shown). The processor 150 is, for example, a CPU or the like, and controls an irradiation unit 110, a detection unit 120, a sleeper 130, and a first storage unit 140. The auxiliary storage unit of the first storage unit 140 includes at least one of an HDD (Hard Disk Drive), an SSD (Solid State Drive), and the like.

The processor 150 can form an image obtained by extracting a tomographic image (two-dimensional data) of a human body or a luminal organ such as a blood vessel from the data acquired by the detection unit 120. The data such as the lumen organ formed by the processor 150 includes three-dimensional coordinates that can be associated with the two-dimensional data, and is stored in the auxiliary storage unit. The first acquisition unit 100 is electrically connected to the main server 400 and is configured to be able to transmit the data stored in the auxiliary storage unit to the main server 400. The position of the three-dimensional coordinates stored in the auxiliary storage unit may be specified by the processor 150 or may be specified by the user from the input / output unit 160. Further, the first acquisition unit 100 may be electrically connected to the main server 400 by wire or may be electrically connected wirelessly.

The input / output unit 160 can include at least one of a mouse, a keyboard, buttons, a touch panel, a display, and the like. The input / output unit 160 allows the user to instruct the first acquisition unit 100 to acquire the three-dimensional coordinates, and can visually display the acquired three-dimensional coordinates to the user.

(2nd acquisition department)
Next, an image diagnostic catheter (hereinafter referred to as an image catheter or a catheter device) will be described as an example of the second acquisition unit. FIG. 2 is a diagram illustrating a pullback in the diagnostic imaging catheter according to the second acquisition unit 200. FIG. 3 is a diagram showing the distal end side of the diagnostic imaging catheter according to the second acquisition unit 200. FIG. 4 is a cross-sectional view showing the proximal end side of the diagnostic imaging catheter.

The second acquisition unit 200 according to the present embodiment is a dual type diagnostic imaging catheter having both functions of an intravascular ultrasonic diagnostic method (IVUS) and an optical coherence tomography diagnostic method (OCT). However, the medical device that can be connected to the external device 300 is not limited to the above, and may be, for example, a catheter for IVUS or a catheter used for purposes other than obtaining a diagnostic image (for example, a therapeutic catheter).

The diagnostic imaging catheter according to the second acquisition unit 200 will be described with reference to FIGS. 1 to 4.

As shown in FIG. 1, the diagnostic imaging catheter according to the second acquisition unit 200 is driven by being connected to the external device 300.

Outlined with reference to FIGS. 1, 2 (A) and 2 (B), the diagnostic imaging catheter according to the second acquisition unit 200 is a long sheath (“medical use”) inserted into the body cavity of a living body. It has a 210 (corresponding to a "long body") and an outer tube 220 provided on the base end side of the sheath 210. The diagnostic imaging catheter includes an inner shaft 230 that is movably inserted into the outer tube 220, a drive shaft 240 that has a signal transmission / reception unit 245 at the tip and is rotatably provided in the sheath 210. Has. The diagnostic imaging catheter has a unit connector 250 provided on the proximal end side of the outer tube 220 and configured to receive the inner shaft 230, and a hub 260 provided on the proximal end side of the inner shaft 230. There is.

Here, in the description of the specification, the side inserted into the body cavity of the diagnostic imaging catheter is referred to as the distal end side, the hub 260 side provided in the diagnostic imaging catheter is referred to as the proximal end side, and the extending direction of the sheath 210 is referred to as the extending direction. It is called the axial direction.

The sheath 210 is inserted into the luminal organ of the subject.

As shown in FIG. 2A, the drive shaft 240 passes through the sheath 210, the outer tube 220 connected to the base end of the sheath 210, and the inner shaft 230 inserted into the outer tube 220, and reaches the inside of the hub 260. It is postponed. A signal transmission / reception unit 245 capable of transmitting / receiving waves having a predetermined wavelength (about several MHz) is provided at the tip of the drive shaft 240.

The hub 260, the inner shaft 230, the drive shaft 240, and the signal transmission / reception unit 245 are connected to each other so as to move forward and backward in the axial direction. Therefore, for example, when the hub 260 is pushed toward the tip side, the inner shaft 230 connected to the hub 260 is pushed into the outer tube 220 and the unit connector 250.

Then, the drive shaft 240 and the signal transmission / reception unit 245 move inside the sheath 210 toward the tip side. For example, when the hub 260 is pulled toward the proximal end side, the inner shaft 230 is pulled out from the outer tube 220 and the unit connector 250 as shown by the arrow a1 in FIGS. 1 and 2B. Further, when the hub 260 is pulled toward the proximal end side, the drive shaft 240 and the signal transmitting / receiving unit 245 move inside the sheath 210 toward the proximal end side as shown by the arrow a2 in FIG.

As shown in FIG. 2A, when the inner shaft 230 is pushed most toward the tip side, the tip portion of the inner shaft 230 reaches the vicinity of the relay connector 270. At this time, the signal transmission / reception unit 245 is located near the tip of the sheath 210. The relay connector 270 is a connector for connecting the sheath 210 and the outer tube 220.

As shown in FIG. 2B, a connector 231 for preventing disconnection is provided at the tip of the inner shaft 230. The disconnection prevention connector 131 has a function of preventing the inner shaft 230 from detaching from the outer pipe 220. The disconnection prevention connector 231 is configured so that when the hub 260 is pulled to the most proximal side, it is caught in a predetermined position on the inner wall of the unit connector 250.

As shown in FIG. 3, the drive shaft 240 includes a flexible tube body 241, and an electric signal cable 242 and an optical fiber 243 connected to a signal transmission / reception unit 245 are arranged inside the drive shaft 240. The tube body 241 can be composed of, for example, a multi-layer coil having different winding directions around the axis. Examples of coil constituent materials include stainless steel and Ni-Ti (nickel-titanium) alloys. In the present embodiment, the electric signal cable 242 is electrically connected to the electrode terminal 265b provided in the connector portion 265, which will be described later. The electric signal cable 242 is configured to include two

signal lines

242a and 242b in order to transmit and receive a high frequency voltage.

As shown in FIG. 3, the signal transmission / reception unit 245 has an ultrasonic wave transmission / reception unit 245a for transmitting / receiving ultrasonic waves and an optical transmission / reception unit 245b for transmitting / receiving light.

The ultrasonic transmission / reception unit 245a is provided with a vibrator, and has a function of transmitting ultrasonic waves based on a pulse signal into the body cavity and receiving ultrasonic waves reflected from living tissues in the body cavity. The ultrasonic transmission / reception unit 245a is electrically connected to the electrode terminal 265b on the proximal end side of the diagnostic imaging catheter via an electric signal cable 242.

As the vibrator included in the ultrasonic transmission / reception unit 245a, for example, a piezoelectric material such as ceramics or quartz can be used.

The light transmission / reception unit 245b continuously transmits the transmitted measurement light into the body cavity and continuously receives the reflected light from the living tissue in the body cavity. The light transmission / reception unit 245b has a ball lens (optical element) provided at the tip of the optical fiber 243 and having a lens function for collecting light and a reflection function for reflecting light.

The signal transmission / reception unit 245 is housed inside the housing 246 as shown in FIG. The base end side of the housing 246 is connected to the drive shaft 240. As shown in FIG. 3, the housing 246 is provided with an opening on the cylindrical surface of a cylindrical metal pipe so as not to obstruct the progress of ultrasonic waves transmitted and received by the ultrasonic transmission / reception unit 245a and light transmitted / received by the optical transmission / reception unit 245b. It has a good shape.

As shown in FIG. 3, the sheath 210 includes a lumen 210a into which the drive shaft 240 is inserted so as to be movable back and forth. A guide wire insertion member 214 having a guide wire lumen 214a through which the guide wire G can be inserted is attached to the tip of the sheath 210 in parallel with the lumen 210 a provided on the sheath 210.

The sheath 210 and the guide wire insertion member 214 can be integrally configured by heat fusion or the like. The guide wire insertion member 214 is provided with a marker 215 having X-ray contrast property. The marker 215 is composed of a metal coil having high X-ray impermeable properties such as Pt and Au. Further, by providing the marker in the housing 246, the position of the signal transmission / reception unit 245 and the three-dimensional coordinates acquired by the first acquisition unit 100 can be identified in real time from the contrast image.

A communication hole 216 that communicates the inside and the outside of the lumen 210a is formed at the tip of the sheath 210. Further, a reinforcing member 217 for firmly joining and supporting the guide wire insertion member 214 is provided at the tip of the sheath 210.

The reinforcing member 217 is formed with a communication passage 217a that communicates the inside of the lumen 210a arranged on the proximal end side of the reinforcing member 217 with the communication hole 216. The reinforcing member 217 may not be provided at the tip of the sheath 210.

The communication hole 216 is a priming liquid discharge hole for discharging the priming liquid. When using the diagnostic imaging catheter, a priming process is performed in which the priming liquid is filled in the sheath 210 in order to reduce the attenuation of the ultrasonic waves due to the air in the sheath 210 and efficiently transmit and receive the ultrasonic waves. When the priming process is performed, the priming liquid can be discharged to the outside through the communication hole 216, and a gas such as air can be discharged from the inside of the sheath 210 together with the priming liquid.

The sheath 210, the guide wire insertion member 214, and the reinforcing member 217 are made of a flexible material, and the material is not particularly limited, and examples thereof include styrene-based, polyolefin-based, polyurethane-based, polyester-based, and polyamide-based. Examples include various thermoplastic elastomers such as polyimide-based, polybutadiene-based, transpolyisoprene-based, fluororubber-based, and chlorinated polyethylene-based, and one or a combination of two or more of these (polymer alloy, polymer blend). , Laminates, etc.) can also be used. A hydrophilic lubricating coating layer that exhibits lubricity when wet can be arranged on the outer surface of the sheath 210.

As shown in FIG. 4, the hub 260 includes a hub body 261 having a hollow shape, a connector case 265c connected to the base end side of the hub body 261, and a port 262 communicating with the inside of the hub body 261. ..

The hub 260 includes

protrusions

263a and 263b for determining the position (direction) of the hub 260 when connecting to the external device 300, and a connection pipe 264b for holding the drive shaft 240.

The hub 260 includes a bearing 264c that rotatably supports the connecting pipe 264b, and a sealing member 264a that prevents the priming liquid from leaking from between the connecting pipe 264b and the bearing 264c toward the proximal end side. The hub 260 includes an electrode terminal 265b connected to the external device 300 and a connector portion 265 in which the optical connector 265a is arranged inside.

The inner shaft 230 is connected to the tip of the hub body 261. The drive shaft 240 is pulled out from the inner shaft 230 inside the hub body 261.

An injection device S (see FIG. 1) for injecting the priming liquid is connected to the port 262 when performing the priming process. The injection device S includes a connector S1 connected to the port 262, a tube S2 connected to the connector S1, and a three-way stopcock S3 connected to the tube S2.

The injection device S includes a first syringe S4 and a second syringe S5 that are connected to the three-way stopcock S3 and capable of injecting the priming liquid into the port 262. The second syringe S5 is a syringe that has a larger capacity than the first syringe S4 and is used as an auxiliary when the amount of the priming liquid to be injected by the first syringe S4 is insufficient.

The connection pipe 264b holds the drive shaft 240 in order to transmit the rotation of the electrode terminal 265b and the optical connector 265a, which are rotationally driven by the external device 300, to the drive shaft 240. An electric signal cable 242 and an optical fiber 243 are inserted inside the connecting pipe 264b.

The connector portion 265 includes an optical connector 265a that is optically connected to an optical fiber and an electrode terminal 265b that is electrically connected to an electric signal cable 242. The received signal in the ultrasonic transmission / reception unit 245a is transmitted to the external device 300 via the electrode terminal 265b, subjected to predetermined processing, and displayed as an image. The received signal in the optical transmission / reception unit 245b is transmitted to the external device 300 via the optical connector 265a, is subjected to predetermined processing, and is displayed as an image.

(External device)
With reference to FIG. 3, the diagnostic imaging catheter according to the second acquisition unit 200 is connected to and driven by the external device 300.

As described above, the external device 300 is connected to the connector portion 265 (see FIG. 4) provided on the base end side of the hub 260.

Further, as shown in FIG. 1, the external device 300 includes a motor 300a which is a power source for rotating the drive shaft 240 and a motor 300b which is a power source for moving the drive shaft 240 in the axial direction. Have. The rotational motion of the motor 300b is converted into axial motion by the ball screw 300c connected to the motor 300b.

The operation of the external device 300 is controlled by the control device 301 electrically connected to the external device 300. The control device 301 includes a second storage unit 301b (corresponding to a storage unit), a processor 301a (corresponding to a setting unit), and an input unit 301c. The control device 301 is electrically connected to the monitor 302. The processor 301a generates two-dimensional data of the luminal organ from the signal acquired by the signal transmission / reception unit 245.

The second storage unit 301b stores the two-dimensional data generated from the signal acquired (received) by the second acquisition unit 200. The second storage unit 301b is a ROM for storing programs and the like used when generating two-dimensional data, a RAM for temporarily storing programs and data as a work area, and an auxiliary for storing the generated two-dimensional data and the like. It is equipped with a storage unit and the like.

The 3D image data of the luminal organ is generated by the main server 400, which will be described later, using the tomographic images of a plurality of frames acquired by the diagnostic imaging catheter according to the second acquisition unit 200. Here, the number of frames of the tomographic image used for 3D image data generation is the remaining storage capacity of the auxiliary storage unit related to the second storage unit 301b at the time when the second storage unit 301b associates the three-dimensional coordinates with the two-dimensional data. Set based on. Here, the remaining storage capacity at the time point is the remaining storage capacity at the time point or the maximum storage capacity that can be set by the user for one 3D image data in the auxiliary storage unit constituting the second storage unit 301b. It means the remaining storage capacity at the time point. When the user does not set the usable storage capacity for each 3D image data, the usable storage capacity for the 3D image data may be set to be changeable in advance as an initial setting.

The auxiliary storage unit of the second storage unit 301b stores the signal or the like received by the signal transmission / reception unit 245. The auxiliary storage unit of the second storage unit 301b includes at least one such as an HDD (Hard Disk Drive), an SSD (Solid State Drive), a memory card, a CD, a DVD, and a BD (Blu-ray (registered trademark) Disc). Can be configured as The control device 301 is electrically connected to the main server 400, and can transmit a cross-sectional image (two-dimensional data) generated by the control device 301 from the signal received by the signal transmission / reception unit 245 to the main server 400.

The processor 301a selects the two-dimensional data associated with the three-dimensional coordinates from the two-dimensional data stored in the second storage unit 301b based on the range for generating the 3D image data specified by the input unit 301c described later. Processor 301a has one or more processors. The processor 301a is, for example, one of a CPU (Central Processing Unit), an MPU (Micro Processing Unit), a GPU (Graphics Processing Unit), and the like.

FIG. 5 is a diagram showing a generation position of two-dimensional data acquired by the second acquisition unit 200. FIG. 6 is a diagram showing a case where the generated two-dimensional data is deleted. The 3D image data is generated from the two-dimensional data (tomographic image) acquired in a predetermined frame by the second acquisition unit 200 as described above. The acquired two-dimensional data is generated by the second acquisition unit 200 at intervals as shown in position 1-10 in the longitudinal direction of the luminal organ.

The medical worker moves the drive shaft 240 forward and backward in the luminal organ when obtaining a tomographic image at a predetermined position using the diagnostic imaging catheter according to the second acquisition unit 200.

The medical staff basically moves the drive shaft 240 from the distal end side to the proximal end side or from the proximal end side to the distal side in one direction as shown in data 1-5 of FIG. Sends and receives signals necessary for generating images.

However, during the procedure, if necessary, the drive shaft 240 passes through the same position multiple times in the longitudinal direction of the luminal organ such as a blood vessel as shown in

positions

6 and 7 of data 6-9 in FIG. In some cases, two-dimensional data may be generated.

In the present embodiment, when the second storage unit 301b stores a plurality of two-dimensional data at the same position in the luminal organ as shown in positions 6 and 7 (data 6-9) in FIG. 6, the second storage unit 301b to the above 2 Reduce any of the dimensional data.

The processor 301a receives (acquires) a signal required for 3D image data generation when the generated two-dimensional data are at the same position in the lumen organ, that is, the acquisition time is not the latest, that is, the acquisition time is old. It is deleted from the second storage unit 301b. Specifically, in FIG. 6,

data

6 and 7 are deleted. The time may be the two-dimensional data generation time instead of the signal acquisition time required for the two-dimensional data generation.

The input unit 301c is configured so that the range of the two-dimensional data can be specified when associating the two-dimensional data with the three-dimensional coordinates acquired by the first acquisition unit 100 in order to generate the 3D image data. The input unit 301c is configured so that the area where the 3D image data is to be generated in the present embodiment can be specified as a start point and an end point. Further, the input unit 301c may be configured so that the storage capacity of the auxiliary storage unit that can be used for one 3D image data can be specified. The input unit 301c can be configured to include at least one of a mouse, a keyboard, a touch panel, a button, and the like.

(Main server)
The main server 400 stores the three-dimensional coordinates acquired by the first acquisition unit 100 and the two-dimensional data generated by the second acquisition unit 200 in association with each other. The main server 400 includes a third storage unit 410, a processor 420, and an input / output unit 430.

The third storage unit 410 stores the three-dimensional coordinates acquired by the first acquisition unit 100 and the two-dimensional data generated by the second acquisition unit 200 in association with each other. Specifically, when the above-mentioned signal transmission / reception unit 245 receives an ultrasonic wave at a specific position, the position is collated with the three-dimensional coordinates acquired by the first acquisition unit 100. As a result, when the second acquisition unit 200 receives the ultrasonic signal while pulling back and generates the two-dimensional data, the generation position of the two-dimensional data can be identified in real time.

The third storage unit 410 includes a RAM, a ROM, an auxiliary storage unit, and the like. A program for associating the three-dimensional coordinates with the two-dimensional data is stored in the ROM, and the three-dimensional coordinates acquired from the first acquisition unit 100 and the two-dimensional data generated by the second acquisition unit 200 are read out in the RAM. Data in which three-dimensional coordinates and two-dimensional data are associated with each other is stored in the auxiliary storage unit.

The auxiliary storage unit is not particularly limited, but can be configured to include an HDD, SSD, etc. like the first acquisition unit 100 and the like.

The processor 420 is configured to associate the three-dimensional coordinates acquired by the first acquisition unit 100 with the two-dimensional data generated by the second acquisition unit 200.

Processor 420 has one or more processors. The processor 420 is, for example, one of a CPU (Central Processing Unit), an MPU (Micro Processing Unit), a GPU (Graphics Processing Unit), and the like.

The 2D data generated by the diagnostic imaging catheter according to the 2nd acquisition unit 200 can generate 3D image data based on the 3D coordinates by a method such as volume rendering.

The input / output unit 430 is configured so that it can be instructed to associate the three-dimensional coordinates acquired by the first acquisition unit 100 with the two-dimensional data generated by the second acquisition unit 200. The input / output unit 430 can include a mouse, a keyboard, buttons, a display, a touch panel, and the like.

(Example of use)
Next, a method using the medical system 1 according to the present embodiment will be described.

Generally, in PCI, a balloon catheter or the like is placed and expanded in a stenosis such as a blood vessel of a patient (also referred to as pre-dilation), a stent or the like is placed in the stenosis, and a balloon catheter or the like is placed in the stenosis. And then expand (also called post-extension). The method described below can be performed at the time of pre-extension and post-extension.

First, the medical staff places the subject on the sleeper 130 of the first acquisition unit 100, operates the input / output unit 160, and uses the irradiation unit 110, the detection unit 120, and the like to three-dimensionalize the blood vessel of the subject. The coordinates are acquired (stored) in the first storage unit 140 (S1).

Next, the medical staff generates two-dimensional data using the second acquisition unit 200.

Specifically, the medical staff connects the device for injecting the priming liquid to the port 262 with the hub 260 pulled to the most proximal side, and injects the priming liquid into the lumen 210a of the sheath 210.

When the priming liquid is injected into the lumen 210a, the priming liquid is discharged to the outside of the sheath 210 through the communication passage 217a and the communication hole 216. As a result, a gas such as air can be discharged from the inside of the sheath 210 to the outside together with the priming liquid.

After the priming process, the user connects the external device 300 to the connector portion 265 of the diagnostic imaging catheter as shown in FIG. Then, the user pushes the hub 260 until it comes into contact with the base end of the unit connector 250, and moves the signal transmission / reception unit 245 toward the tip end side.

Next, the healthcare professional uses the introducer kit to form a port on the wrist or thigh. Next, a guide wire (not shown) is inserted near the entrance of the coronary artery (coronary artery) of the heart of the living body. Then, the guiding catheter is inserted into the target site along the guide wire. The surgeon then removes the guide wire and inserts another guide wire through the guiding catheter to the lesion. Next, the diagnostic imaging catheter according to the second acquisition unit 200 is inserted to the lesion portion along another guide wire.

Next, the tip of the diagnostic imaging catheter is projected from the tip opening of the guiding catheter. A known guiding catheter can be used.

Next, the blood in the blood vessel is temporarily replaced with a flash solution such as a contrast medium, and the blood in the blood vessel is temporarily replaced with the flash solution. Similar to the priming process described above, the syringe containing the flush solution is connected to the port of the guiding catheter, and the pusher of the syringe is pushed to inject the flush solution into the lumen of the guiding catheter.

The flush fluid passes through the lumen of the guiding catheter and is introduced into the blood vessel through its tip opening. The introduced flush liquid flushes the blood around the tip of the sheath 210, and the flash liquid is filled around the tip of the sheath 210. In the mode of acquiring the tomographic image only by IVUS, the step of replacing with the flash liquid described above can be omitted.

When obtaining a tomographic image at a target position in a blood vessel, the signal transmission / reception unit 245 moves to the proximal end side while rotating together with the drive shaft 240 (pullback operation). At the same time as the pullback operation, the ultrasonic transmission / reception unit 245a transmits the ultrasonic waves toward the blood vessel wall and receives the ultrasonic waves reflected by the blood vessel wall.

At the same time, the light transmission / reception unit 245b also transmits the measurement light toward the blood vessel wall and receives the reflected light reflected by the blood vessel wall. As described above, since the ultrasonic wave transmitted from the ultrasonic transmission / reception unit 245a and the measurement light transmitted from the light transmission / reception unit 245b intersect, the region inspected by the ultrasonic wave in the living body and the light are inspected. Areas can be overlapped.

The rotation and movement operations of the drive shaft 240 are controlled by the control device 301. The connector portion 265 provided in the hub 260 is rotated while being connected to the external device 300, and the drive shaft 240 is rotated in conjunction with this.

Further, based on the signal sent from the control device 301, the signal transmission / reception unit 245 transmits ultrasonic waves and light into the body. The signal corresponding to the reflected wave and the reflected light received by the signal transmitting / receiving unit 245 is sent to the control device 301 via the drive shaft 240 and the external device 300. The control device 301 generates a tomographic image (two-dimensional data) of the luminal organ based on the signal sent from the signal transmission / reception unit 245 (S2).

The medical staff specifies the region of the luminal organ that he / she wants to generate as a three-dimensional image from the three-dimensional coordinates acquired by the first acquisition unit 100 through the input unit 301c and the two-dimensional data generated by the second acquisition unit 200 (S3). ).

The processor 301a calculates the size of an area that can be used as a storage area for the three-dimensional image data of the luminal organ in the auxiliary storage unit of the second storage unit 301b.

Then, the processor 301a calculates the interval (number of frames) of the area from the start point to the end point in the tomographic image generated by the second acquisition unit 200 based on the capacity of the storage area available in the second storage unit 301b. ..

The processor 420 of the main server 400 uses the program of the third storage unit 410 to input the three-dimensional coordinates from the first acquisition unit 100 and the two-dimensional data specified by the second acquisition unit 200 according to the instruction from the input / output unit 430. And store it in the auxiliary storage unit of the third storage unit 410.

Therefore, the two-dimensional data acquired from the second acquisition unit 200 is partially used depending on the relationship between the current capacity of the auxiliary storage unit of the second storage unit 301b and the area designated by the user for generating 3D image data. NS. For example, the processor 301a uses every other two-dimensional data generated by the second acquisition unit 200 in the long axis direction of the luminal organ, and deletes the remaining two-dimensional data from the second storage unit 301b.

In addition to the above, when there are a plurality of two-dimensional data at the same position of the luminal organ as shown in FIG. 6, the processor 301a transmits the two-dimensional data other than the latest time from the second storage unit 301b. It can also be deleted.

The two-dimensional data generated by the second acquisition unit 200 in this way is sorted by the processor 301a, associated with (corresponds to) the three-dimensional coordinates acquired by the first acquisition unit 100, and then associated with the third storage unit 410. It is stored (stored / saved) in (S4).

As described above, the medical system 1 according to the present embodiment includes a first acquisition unit 100, a second acquisition unit 200, a second storage unit 301b, an input unit 301c, and a processor 301a. The first acquisition unit 100 is configured to be able to acquire the three-dimensional coordinates of the luminal organ of the subject. The second acquisition unit 200 is inserted into the tract organ of the subject, has a signal transmission / reception unit 245 capable of transmitting / receiving waves of a predetermined wavelength at the tip, and has two-dimensional data from the signal acquired by the signal transmission / reception unit 245. Is configured to enable the generation of. The second storage unit 301b is configured to store the two-dimensional data generated from the signal acquired by the second acquisition unit 200. The input unit 301c is configured to be able to specify the range of the two-dimensional data associated with the three-dimensional coordinates when associating the three-dimensional coordinates with the two-dimensional data. The processor 301a is configured to select the two-dimensional data associated with the three-dimensional coordinates from the two-dimensional data stored in the second storage unit 301b based on the range specified by the input unit 301c.

In this way, the processor 301a is configured to select the two-dimensional data stored in the second storage unit 301b when generating the 3D image data of the luminal organ. Therefore, it is possible to prevent the amount of data stored in the second storage unit 301b from becoming excessively large.

Further, when a plurality of two-dimensional data are acquired at the same position in the longitudinal direction in the luminal organ such as a blood vessel, any one of the two-dimensional data at the same position stored in the second storage unit 301b is deleted. ing. Only one 2D data at the same position is required to generate 3D image data of the luminal organ, and the remaining 2D data at the same position is likely to be unnecessary. Therefore, the two-dimensional data can be efficiently stored in the second storage unit 301b by the above configuration.

Further, as described above, the time when the signal is acquired or the time when the two-dimensional data is generated is given to the two-dimensional data. When a plurality of two-dimensional data are generated at the same position of the lumen organ, the data to be deleted is configured so that either the signal acquisition time or the two-dimensional data generation time related to the two-dimensional data is the old two-dimensional data. .. The fact that a plurality of signal transmission / reception units 245 pass through the same position can be considered to mean that it is more necessary to pass through the luminal organ at the new time than at the old time. Therefore, by configuring as described above, the two-dimensional data necessary for generating 3D image data of the luminal organ can be efficiently stored in the second storage unit 301b.

In addition, two-dimensional data is acquired in multiple frames in order to generate a 3D image of the luminal organ. The number of frames of the two-dimensional data is set in the second storage unit 301b based on the storage capacity at the time when the three-dimensional coordinates and the two-dimensional data are associated with each other. With this configuration, regardless of the storage capacity of the second storage unit 301b at the above time point, it is possible to prevent a situation such as a situation in which a huge amount of two-dimensional data is stored and the system operation is slowed down. can do.

(Second Embodiment)
FIG. 8 is a diagram showing the medical system 1a according to the second embodiment, and FIG. 9 is a flowchart showing a 3D image data generation method according to the second embodiment. In the first embodiment, it has been described that the area for generating the 3D image is set after the second acquisition unit 200 acquires the two-dimensional data, but it can also be configured as follows.

The medical system 1a according to this embodiment will be described below. As shown in FIG. 8, the medical system 1a includes a first acquisition unit 100, a second acquisition unit 200, an external device 300A, a main server 400A, and an angio device 500. Since the first acquisition unit 100 and the second acquisition unit 200 are the same as those in the first embodiment in the present embodiment, the description thereof will be omitted.

(External device)
The external device 300A includes

motors

300a and 300b, a ball screw 300c, a control device 301A, and a monitor 302. Since the

motors

300a and 300b, the ball screw 300c, and the monitor 302 of the external device 300A are the same as those in the first embodiment, the description thereof will be omitted.

The control device 301A includes a processor 301d (corresponding to a "setting unit"), a second storage unit 301e (corresponding to a "storage unit"), and an input unit 301f.

The processor 301d uses the data amount of the two-dimensional data of the lumen organ stored in the second storage unit 301e in association with the three-dimensional coordinates acquired by the first acquisition unit 100 based on the range specified by the input unit 301f. And set.

The processor 301d uses the matching result of the two-dimensional data from the angio apparatus 500 and the two-dimensional data from the first acquisition unit 100 performed by the processor 420a, which will be described later, and data based on the range specified from the input unit 301c. Set the acquisition interval. The two-dimensional data by the first acquisition unit 100 and the two-dimensional data by the angio device 500 can be read from the third storage unit 410a of the main server 400A.

The second storage unit 301e stores the two-dimensional data generated from the signal acquired by the second acquisition unit 200 as in the first embodiment. The second storage unit 301e includes a ROM, a RAM, and an auxiliary storage unit in the same manner as the second storage unit 301b. In the RAM of the second storage unit 301e, the matching result of the two-dimensional data of the first acquisition unit 100 and the angio device 500 read from the third storage unit 410a of the main server 400A can be temporarily stored. The ROM of the second storage unit 301e can store a program or the like for acquiring two-dimensional data within a range designated from the input unit 301f and an interval calculated by the processor 301d. The auxiliary storage unit of the second storage unit 301e can be configured in the same manner as in the first embodiment.

The input unit 301f is configured to be able to specify the range of the two-dimensional data associated with the three-dimensional coordinates acquired by the first acquisition unit 100 when associating the three-dimensional coordinates with the two-dimensional data. The input unit 301f is configured to be able to set a start point and an end point for the angio image data of the angio device 500 associated with the three-dimensional coordinates acquired by the first acquisition unit 100 in the present embodiment. Details will be described later.

(Main server)
The main server 400A stores the three-dimensional coordinates acquired by the first acquisition unit 100 and the two-dimensional data generated by the second acquisition unit 200 in association with each other. As shown in FIG. 1, the main server 400A includes a third storage unit 410a, a processor 420a, and an input / output unit 430a.

The third storage unit 410a can be provided with a ROM, a RAM, an auxiliary storage unit, and the like as in the first embodiment. In the ROM of the third storage unit 410a, a program or the like that compares the image obtained by the first acquisition unit 100 with the two-dimensional data from the angio device 500 and identifies the most similar image can be stored (stored).

The RAM of the third storage unit 410a can store the two-dimensional data acquired from the first acquisition unit 100 and the two-dimensional data of the angio image acquired from the angio device 500. The auxiliary storage unit of the third storage unit 410a can store the matching result of the two-dimensional data of the first acquisition unit 100 and the angio device 500. From these data, the two-dimensional data of the angio apparatus 500 can be associated with the three-dimensional coordinates of the first acquisition unit 100.

(Angio device)
The angio device 500 is configured to be able to acquire an angio image of a luminal organ. The angio device 500 is the same as the first acquisition unit 100 except that the irradiation unit 110 and the detection unit 120 are not rotatable like the gantry of the first acquisition unit 100. Therefore, detailed description will be omitted.

(Example of use)
Next, the 3D image data generation method according to the present embodiment will be described with reference to FIG.

First, the medical worker places the subject on the sleeper 130 of the first acquisition unit 100, gives an instruction from the input / output unit 160, and uses the irradiation unit 110, the detection unit 120, and the like to perform 2 in the blood vessel of the subject. The first storage unit 140 acquires (stores) the dimensional data and the three-dimensional coordinates (S1).

Next, the medical worker injects a contrast medium into a luminal organ such as a blood vessel, and uses the angio device 500 to display an angio image (two-dimensional data) of the luminal organ on a display or the like related to the input / output portion of the angio device 500. It is in the displayed state (S2). The image displayed on the input / output unit of the angio device 500 can be transmitted as data to the main server 400A.

Next, the medical staff operates the input / output unit 430a of the main server 400A to compare the two-dimensional data acquired by the first acquisition unit 100 with the two-dimensional data of the angio image by the angio device 500 and perform pattern matching. (S3). Since the two-dimensional data of the first acquisition unit 100 is associated with the three-dimensional coordinates, the two-dimensional data by the angio device 500 can be associated with the three-dimensional coordinates acquired by the first acquisition unit 100 by the above matching (S4). ..

Next, the medical worker specifies the region of the luminal organ to be generated as a three-dimensional image from the three-dimensional coordinates acquired by the first acquisition unit 100 through the input unit 301f and the two-dimensional image by the angio image as the start point to the end point. (S5).

Next, the processor 301d calculates the size of an area that can be used as a storage area for the three-dimensional image data of the luminal organ in the auxiliary storage unit of the second storage unit 301e.

Then, the processor 301d calculates the data acquisition interval in the range from the start point to the end point designated from the input unit 301f based on the capacity of the storage area available in the second storage unit 301e (S6).

Then, the second acquisition unit 200 acquires the two-dimensional data of the luminal organ (S7). When acquiring an image at a set interval, the signal transmission / reception unit 245 can acquire two-dimensional data every time the image is moved at a set interval based on the angio image acquired by the angio device 500. Further, since the acquisition of the tomographic image in the luminal organ by the second acquisition unit 200 is the same as the step of S2 in FIG. 7 in the first embodiment, the description thereof will be omitted.

The processor 420a of the main server 400A uses the input / output unit 430a to instruct (input) the three-dimensional coordinates from the first acquisition unit 100 and the two-dimensional data acquired by the second acquisition unit 200 to program the third storage unit 410a. Correspond using. Then, the processor 420a stores the data in the auxiliary storage unit of the third storage unit 410a.

As described above, in the present embodiment, the medical system 1a includes a first acquisition unit 100, a second acquisition unit 200, a second storage unit 301e, a processor 301d, and an input unit 301f. The first acquisition unit 100 acquires the three-dimensional coordinates of the luminal organ of the subject. The second acquisition unit 200 includes a signal transmission / reception unit 245 inserted into the tract organ of the subject and capable of transmitting / receiving waves of a predetermined wavelength at the tip, and two-dimensional data from the signal acquired by the signal transmission / reception unit 245. To generate. The second storage unit 301e stores the two-dimensional data generated from the signal acquired by the second acquisition unit 200. The input unit 301f is configured so that the range of the two-dimensional data associated with the three-dimensional coordinates can be specified when associating the three-dimensional coordinates with the two-dimensional data. The processor 301d sets the amount of two-dimensional data of the luminal organ stored in the second storage unit 301e in association with the three-dimensional coordinates based on the above range.

With this configuration, it is possible to prevent the amount of data stored in the two-dimensional data stored in the second storage unit 301e from becoming excessively large.

Further, the medical system 1a has an angio device 500 capable of acquiring an angio image of a luminal organ. The first acquisition unit 100 is configured to be able to acquire two-dimensional data of the luminal organ associated with the three-dimensional coordinates. Further, the input unit 301f is configured to specify the above range for the angio image data from the angio device 500 associated with the three-dimensional coordinates acquired by the first acquisition unit 100. With this configuration, it is possible to prevent the amount of data stored in the second storage unit 301e from becoming excessively large as described above.

Further, the second storage unit 301e is configured to store the two-dimensional data acquired at the set intervals from the start point to the end point. Therefore, it is possible to prevent the amount of data stored in the second storage unit 301e from becoming excessively large without going through the process of deleting data from the second storage unit as in the first embodiment.

Note that the present disclosure is not limited to the above-described embodiment, and various changes can be made within the scope of the claims.

In the above, when the second acquisition unit 200 generates a plurality of two-dimensional data at the same position in the lumen organ and the processor 301a deletes any of the two-dimensional data, it is assumed that the two-dimensional data to be deleted has an older time. The embodiment has been described. However, the present disclosure is not limited to the above as long as the storage efficiency of the second storage unit can be improved.

10 and 11 are diagrams showing a case where any of the two-dimensional data generated by the second acquisition unit is selected by using the trained model generated by machine learning in one embodiment of the present disclosure.

In addition to the above, the two-dimensional data generated by the second acquisition unit 200 is input with either a correct label or an abnormal label, and the processor 301a deletes the data using the trained model generated by machine learning. It may be configured to sort the images.

The image to which the correct answer label is attached can be an image having no noise or very little noise as in the two-dimensional data shown in FIG. 10, for example. As shown in FIG. 11, the image with the abnormality label can be an image containing noise N (also called an artifact) such as a shadow of a guide wire or blurring of the image. The generated trained model is stored in a ROM or the like constituting the second storage unit.

In this way, when a plurality of data at the same position in the luminal organ are acquired, the data to be deleted can be selected using the trained model generated by machine learning. With this configuration, the amount of two-dimensional data required for 3D image data generation can be made efficient, and the image selection accuracy of the two-dimensional data can be improved.

Further, it was explained that the configuration for designating the range of the two-dimensional data associated with the three-dimensional coordinates with respect to the data of the angio image by the angio device 500 is applied to the medical system 1a according to the second embodiment. However, the designation of the range of the two-dimensional data associated with the three-dimensional coordinates with respect to the data of the angio image of the angio device 500 may be applied to the medical system 1 according to the first embodiment. This application is based on Japanese Patent Application No. 2020-060604 filed on March 30, 2020, and the disclosure contents are incorporated as a whole by reference.

1, 1a medical system,
100 First Acquisition Department,
200 Second Acquisition Department,
300, 300A external device,
301a, 301d processor (setting part),
301b, 301e Second storage unit (storage unit),
301c, 301f input unit.

Claims

The first acquisition part that can acquire the three-dimensional coordinates of the luminal organ of the subject, and
A second acquisition unit that is inserted into the tract organ of the subject and has a transmission / reception unit at the tip capable of transmitting / receiving waves of a predetermined wavelength, and can generate two-dimensional data from the signal acquired by the transmission / reception unit. When,
A storage unit that stores the two-dimensional data generated from the signal acquired by the second acquisition unit, and a storage unit that stores the two-dimensional data.
An input unit capable of specifying a range of the two-dimensional data associated with the three-dimensional coordinates when associating the three-dimensional coordinates with the two-dimensional data.
A medical system including a setting unit that sets a data amount of the two-dimensional data of a lumen organ stored in the storage unit in association with the three-dimensional coordinates based on the range.
The first acquisition part that can acquire the three-dimensional coordinates of the luminal organ of the subject, and
A second acquisition unit that is inserted into the tract organ of the subject and has a transmission / reception unit at the tip capable of transmitting / receiving waves of a predetermined wavelength, and can generate two-dimensional data from the signal acquired by the transmission / reception unit. When,
A storage unit that stores the two-dimensional data generated from the signal acquired by the second acquisition unit, and a storage unit that stores the two-dimensional data.
An input unit capable of specifying a range of the two-dimensional data associated with the three-dimensional coordinates when associating the three-dimensional coordinates with the two-dimensional data.
A medical system including a setting unit that selects the two-dimensional data associated with the three-dimensional coordinates from the two-dimensional data stored in the storage unit based on the range.
It also has an angio device capable of acquiring angio images of luminal organs,
The first acquisition unit can acquire the two-dimensional data associated with the three-dimensional coordinates, and can acquire the two-dimensional data.
The first or second claim, wherein the input unit can specify the range with respect to the data of the angio image of the angio device associated with the three-dimensional coordinates acquired by the first acquisition unit. Medical system.
When a plurality of the two-dimensional data at the same position of the luminal organ are stored in the storage unit, the two-dimensional data at the same position is deleted from the storage unit according to any one of claims 1 to 3. Medical system.
The time when the signal related to the two-dimensional data is acquired or the time when the two-dimensional data is generated is given to the two-dimensional data.
The medical system according to claim 4, wherein the two-dimensional data deleted from the storage unit is selected based on the time.
The medical system according to claim 4, wherein the two-dimensional data deleted from the storage unit is selected using a trained model generated by machine learning.
The two-dimensional data is acquired in a plurality of frames in the range, and the two-dimensional data is acquired.
The medical treatment according to any one of claims 1 to 6, wherein the number of frames of the two-dimensional data is set based on the capacity of the storage unit at the time when the three-dimensional coordinates are associated with the two-dimensional data. system.