Surgery assistance device, surgery assistance method, and surgery assistance program

Abstract

Provided is a surgery assistance device that creates a three-dimensional image of a tissue shape of an affected area of ​​a patient to improve the image of the tissue structure when a doctor performs surgery, and assists in accurate selection of surgical tools to be used in surgery on the basis of the image. The surgery assistance device comprises: a three-dimensional spatial data generation unit that acquires a tomographic image of a subject's chest tissue and generates three-dimensional spatial data of the tissue from the tomographic image; a spatial feature detection unit that detects spatial features of a space into which a surgical tool is to be introduced by recognizing, as a target area of the subject from the three-dimensional spatial data, shapes of the aorta, pulmonary artery, inferior vena cava, left atrium, right atrium, or intracardiac valves, or the position of an entrance into a blood vessel or intracardiac structure to be treated; a measurement unit that measures, on the basis of the spatial features, multiple angles and distances for introducing the surgical tool into the tissue of the subject; and a presentation unit that presents the shape of a surgical tool suitable for introduction into the tissue of the subject on the basis of one or more angles and distances.

Description

Surgery support device, surgery support method, and surgery support program

[0001] The present invention relates to a surgical assistance device, a surgical assistance method, and a surgical assistance program, and in particular to a device, method, and program for assisting in the selection and operation of a surgical tool, such as a catheter, when introducing the tool into tissue.

[0002] Coronary artery bypass surgery and percutaneous coronary intervention (PCI) are primarily used to treat various heart diseases, including ischemic heart disease, while percutaneous left atrial appendage closure is used to treat atrial fibrillation. Percutaneous coronary intervention (PCI) and percutaneous left atrial appendage closure are particularly minimally invasive and less stressful for patients, making them the preferred surgical procedures. During these procedures, a catheter (specifically, a guiding catheter) is introduced into the patient's body from outside and threaded through the coronary arteries of the heart. Then, instruments such as a guidewire and a stent are placed through the guiding catheter at the narrowed portion of the blood vessel. In percutaneous left atrial appendage closure, a left atrial appendage closure device is introduced into the patient's left atrial appendage.

[0003] In this case, the surgeon injects a contrast agent into the patient and, while checking an X-ray angiographic image, guides a surgical tool such as a guiding catheter to the entrance of the patient's coronary artery and introduces (engages) it into the artery. The angiographic image at this time is a flat image without a three-dimensional effect. Therefore, the surgeon must imagine the three-dimensional structure of the coronary arteries of the heart based on their own experience, select the type and size of the guiding catheter, and adjust the angle when introducing the surgical tool such as the guiding catheter.

[0004] In particular, aligning the direction of the tip of the guiding catheter with the extension direction of the blood vessel into which it is introduced (coaxiality) is extremely important from the perspective of releasing instruments and drugs into the blood vessel. However, it is not easy to objectively grasp the coaxiality from the state of an angiographic image. In addition, because there are large individual differences in the shape and size of coronary arteries, multiple types of surgical tools such as guiding catheters with different sizes and shapes are prepared (stocked).

[0005] Therefore, surgeons have had to select the most appropriate surgical tools, such as a guiding catheter or left atrial appendage closure device, based on their own experience, skill (procedure), etc. Although it is possible to select a guiding catheter when identifying the surgical site from pre-operative examination images, in the case of emergency patients, they are forced to select surgical tools, such as a guiding catheter, without sufficient prior consideration.

[0006] In light of this situation, a simulation image generation device has been proposed that creates a three-dimensional image of tissues such as blood vessels from examination images such as X-ray CT scans, and overlays a marker indicating the position and direction of a catheter on the image of the blood vessel (see Patent Document 1). Also, three-dimensional visualization of blood vessels using virtual reality (VR) has been proposed (see Non-Patent Document 1). However, previous devices have not responded to the needs of surgical sites regarding which specific surgical instruments, such as catheters, should be selected.

[0007] JP 2009-022733 A

[0008] Hirouki Higami et al., “A case report of virtual reality-guided percutaneous coronary intervention for anomalous origin of right coronary artery chronic total occlusion”, European Heart Journal - Case Reports (2023), Vol. 7, 1-5

[0009] The present invention has been made in consideration of the above points, and provides a surgery support device, a surgery support method, and a surgery support program that can represent the tissue shape of the patient's affected area in three-dimensional images, thereby improving the surgeon's image of the tissue structure when performing surgery, and that assists in the accurate selection of surgical instruments to be used in surgery based on the images.

[0010] That is, the surgical support device of the embodiment is characterized by comprising: a three-dimensional spatial data generation unit that acquires a tomographic image of the chest tissue of a subject and generates three-dimensional spatial data of the tissue from the tomographic image; a spatial feature detection unit that recognizes the shape of the aorta, pulmonary artery, inferior vena cava, left atrium, right atrium, or intracardiac valves as the target area of ​​the subject from the three-dimensional spatial data, or the position of the entrance of the blood vessel or intracardiac structure to be treated, and detects the spatial features of the space into which the surgical tool is to be introduced; a measurement unit that measures one or more angles and distances for introducing the surgical tool into the subject's tissue based on the spatial features; and a presentation unit that presents the shape of the surgical tool suitable for introduction into the subject's tissue based on the one or more angles and distances.

[0011] Furthermore, in the surgery assistance device, the spatial feature detection unit may present a reference direction that serves as a reference for determining the direction in which a surgical tool is introduced into a target site.

[0012] Furthermore, in the surgery assistance device, the reference direction may be presented based on the shape of the aortic valve or the sinus of Valsalva in the target region.

[0013] Furthermore, in the surgery assistance device, the presentation unit may present the size of the surgical tool when presenting the surgical tool.

[0014] Furthermore, in the surgical support device, the presentation unit may acquire shape information for each of multiple types of surgical instruments that are expected to be introduced into the target area, compare one or more angles and distances with the shape information, and based on the comparison, present one or more surgical instruments from among the multiple types of surgical instruments that are suitable for introduction into the target area of ​​the subject.

[0015] Furthermore, in the surgical support device, when presenting multiple surgical tools suitable for insertion into the target area of ​​the subject, the presentation unit may present the multiple surgical tools by ranking them based on the degree of compatibility with one or more angles and distances.

[0016] Furthermore, in the surgery assistance device, the presentation unit may generate guidance information that guides the introduction of a surgical tool suitable for introduction into a target site of the subject into the target site of the subject.

[0017] Furthermore, in the surgery support device, the three-dimensional spatial data generation unit may display, as guidance information, the angle at which a surgical tool is introduced into a target region of the subject, together with a three-dimensional image of the surgical tool.

[0018] Furthermore, in the surgical assistance device, the spatial feature detection unit may acquire tomographic images of the chest tissues of multiple other subjects as training data, perform machine learning, and detect the spatial features of the space into which the surgical tool is introduced from the target area of ​​the subject.

[0019] Furthermore, in the surgery assistance device, the target region of the subject may be a coronary artery of the heart and the surgical tool may be a catheter. Also, in the surgery assistance device, the target region of the subject may be a left atrial appendage of the heart and the surgical tool may be a left atrial appendage closure device.

[0020] Furthermore, the surgery assistance device may be connected to a surgical tool processing unit that processes the shape of a surgical tool into a shape suitable for introduction into a target site of a subject, based on one or more angles and distances.

[0021] Furthermore, in the surgery support device, the surgical tool processing unit may include a heating unit that heats a catheter, which is a surgical tool, and a gripping unit that grips the catheter.

[0022] The surgical assistance device of the present invention includes a three-dimensional spatial data generation unit that acquires tomographic images of the patient's chest tissue and generates three-dimensional spatial data of the tissue from the tomographic images, a spatial feature detection unit that recognizes the shape of the subject's target area (such as the aorta, pulmonary artery, inferior vena cava, left atrium, right atrium, or intracardiac valves) or the location of the entrance of the target blood vessel or intracardiac structure from the three-dimensional spatial data and detects spatial features of the space into which a surgical tool is introduced, a measurement unit that measures one or more angles and distances for introducing the surgical tool into the patient's tissue based on the spatial features, and a presentation unit that presents the shape of the surgical tool suitable for introduction into the patient's tissue based on the one or more angles and distances. By representing the tissue shape of the patient's affected area in a three-dimensional image, the surgeon can better visualize the tissue structure during surgery and can assist in the accurate selection of surgical tools based on the image. Similarly, the surgical assistance method and surgical program can also improve the visualization of the tissue structure during surgery and can assist in the accurate selection of surgical tools based on the image.

[0023] 1 is a schematic diagram showing the configuration of a surgery support device of an embodiment; FIG. 2 is a block diagram showing the configuration of a surgery support device; FIG. 3 is an example of a tomographic image of a subject's tissue; FIG. 4 is an example of a generated three-dimensional image of tissue; FIG. 5 is an example of a simulation image when a surgical tool is introduced into tissue; FIG. 6 is a schematic diagram for specifying the size of a surgical tool; FIG. 7 is an example of an image displaying the angle at which a surgical tool is introduced into tissue; FIG. 8 is an example of a simulation image showing how a surgical tool is introduced into tissue; (A) is a partially cutaway perspective view of a surgical tool processing unit, (B) is a schematic diagram during processing; (A) is a first schematic diagram showing surgical tool selection, (B) is a second schematic diagram showing surgical tool selection; (A) is a first schematic diagram showing introduction of a surgical tool into the left atrial appendage; (B) is a second schematic diagram showing introduction of a surgical tool into the left atrial appendage; (B) is a first flowchart explaining a surgery support method of an embodiment; (C) is a second flowchart explaining a surgery support method of an embodiment.

[0024] The surgical support device of the embodiment acquires a tomographic image of the subject's tissue, generates a three-dimensional image of the subject's tissue from the tomographic image, and presents surgical tools of suitable shapes and sizes for insertion into the subject's tissue, thereby assisting in the progress of surgery and reducing the burden on the patient and reducing the risk of incorrect surgical tool selection. At the same time, guidance information for introducing surgical tools is presented based on the three-dimensional image of the subject's tissue. This allows the surgeon to easily visualize the surgical area from the three-dimensional structure of the subject's tissue and its surroundings, providing a guide for introducing surgical tools. Additionally, it may be possible to eliminate bias due to the surgeon's skill (technique).

[0025] In the following description of the embodiments, the term "subject" refers to a patient undergoing surgery, and the term "tissue" refers to a cardiac blood vessel, particularly a coronary artery. Unless otherwise specified, the term "surgical tool" refers to a catheter, particularly a guiding catheter, introduced into a coronary artery. Additionally, the term "tissue" includes the left atrial appendage of the heart, and the surgical tool includes a left atrial appendage closure device (e.g., an instrument such as WATCHMAN®) to be placed in the left atrial appendage. The device (and its method and program) of the embodiments is primarily intended to assist in the introduction of a guiding catheter into a patient's coronary artery during percutaneous coronary intervention (PCI) for ischemic heart disease. Furthermore, the apparatus (and the method and program thereof) of the embodiment is intended to assist in the introduction of a left atrial appendage closure device into a patient's left atrial appendage during percutaneous left atrial appendage closure (LAAC) for atrial fibrillation.

[0026] FIG. 1 is a schematic diagram showing the configuration of a surgery support device 1 according to an embodiment. A computer 10 (information processing device) is installed to process information in the surgery support device 1, and a tomographic imaging device 20 is connected to the computer 10 to acquire three-dimensional images of tissue (coronary arteries of the heart). The tomographic imaging device 20 is an X-ray CT scanner, an MRI scanner, or other device. Furthermore, information on the size and shape of a surgical tool 30 is transmitted to the computer 10, input, and classified. In this embodiment, a surgical tool processing unit 40 is optionally connected to the computer 10 (see the description of FIG. 8 below). The surgical tools 30 are guiding catheters 31, 32, and 33 of various shapes and sizes.

[0027] The connection between the computer 10 and the tomography apparatus 20 may be wired or wireless, and connection between remote locations is also envisioned, with an internet line or the like (not shown) intervening between them. In Figure 1, reference numeral 16 denotes a display, 17 denotes a keyboard, and 18 denotes a mouse. Reference numeral 41 denotes an exterior (cover) of the surgical tool processing unit 40, and 45 denotes an opening / closing door.

[0028] 2 is a block diagram showing the configuration of the computer 10 of the surgery support device 1. The surgery support device 1 is made up of hardware necessary for various operational control functions such as reception, calculation execution, storage, and output, and is equipped with a calculation unit 11, a ROM 12, a RAM 13, a storage unit 14, an I / O 15 (input / output interface), etc.

[0029] When each functional unit of the computer 10 is implemented by software, the computer 10 executes instructions in a program, which is software that implements each function. The recording medium that stores this program can be a "non-transitory tangible medium," such as a CD, DVD, semiconductor memory, or programmable logic circuit. The program may also be supplied to the computer 10 of the surgery assistance device 1 via any transmission medium capable of transmitting the program (such as the Internet, other communication networks, or broadcast waves).

[0030] The memory unit 14 of the computer 10 is a known storage device such as an HDD or SSD. The memory unit 14 stores various data, including various data necessary for accumulating, processing, generating, and presenting images. Furthermore, each functional unit that performs various calculations and computations is implemented as a computing element such as a CPU or GPU, which is implemented as the computing unit 11. The tomographic imaging device 20, the surgical tool processing unit 40, and external lines such as an internet line are connected to the I / O 15. The computer 10 may also be various electronic computers (computing resources) such as a personal computer (PC), a mainframe, a workstation, a cloud computing system, or even a tablet terminal, and the display 16, keyboard 17, mouse 18, etc. shown in FIG. 1 are connected to the I / O 15.

[0031] The functional units in the computing unit 11 (computing element) of the computer are shown in the block diagram of Figure 2. Each functional unit includes a three-dimensional space data generating unit 110, a spatial feature detecting unit 120, a measuring unit 130, a presentation unit 140, an output unit 160, etc. If a surgical tool processing unit 40 is provided, a processing amount calculating unit 150 is added to the functional units. The operation and execution of the computing unit 11 of the computer 10 is realized in software terms by a surgery assistance program loaded into the main memory, etc.

[0032] The three-dimensional space data generator 110 acquires a tomographic image of the chest tissue surrounding the heart of the subject, and generates three-dimensional space data of the tissue from the tomographic image. Specifically, a tomographic image of the patient's tissue, in this case, the coronary arteries of the heart, is acquired from the tomographic imaging device 20 (X-ray CT, MRI, etc.) described above. FIG. 3 is an example of a tomographic image obtained by X-ray CT. The illustration is represented by lines. In reality, it is a photograph. As shown in the figure, this example tomographic image (photograph) is planar, and the three-dimensional shape of the tissue (blood vessels), such as its depth, is not directly expressed.

[0033] As shown in the image example in FIG. 4 , the target tissue, and if necessary, the surrounding area of ​​the tissue, is extracted from the tomographic image acquired by the tomography device 20, and three-dimensional spatial data (three-dimensional image) of the tissue is generated. The illustration shows a three-dimensional image 60 based on the three-dimensional spatial data of the coronary arteries of the heart. The three-dimensional spatial data of the coronary arteries (the three-dimensional image 60) generates three-dimensional images of the subject's right coronary artery, left coronary artery, and detailed blood vessels branching from the coronary arteries. The illustration shows the surgical tool 30 (guiding catheter) being introduced from the aorta into the left main coronary artery of the left coronary artery. The generated three-dimensional image of the tissue is stored in the memory unit 14 of the computer 10 or an external server (not shown). Additionally, the three-dimensional spatial data generator 110 generates three-dimensional spatial data of tissues required for percutaneous left atrial appendage closure, such as a partial cross-section of the left atrium 74 of the heart 70 and an enlarged cross-section of the left atrial appendage 77, as shown in FIGS. 11 and 12 .

[0034] 4 and other such three-dimensional spatial data of tissues based on the tomographic images acquired from the tomography apparatus 20 may be, for example, a maximum intensity projection (MIP) method that projects in any direction and displays the maximum value in the projection path, a minimum intensity projection that projects the minimum value, or an arithmetic mean projection (X-ray projection). Of course, other methods for creating three-dimensional images may also be used.

[0035] Furthermore, the three-dimensional spatial data generator 110 can acquire tomographic images of the chest tissues of multiple other subjects as training data, perform machine learning, and generate three-dimensional spatial data of the tissues from the tomographic images. As shown in Figure 4, the coronary arteries of the heart, which are the subject's tissues, have a complex branching structure, and there are large individual differences in the inner diameter and curvature of blood vessels such as the left main coronary artery into which the surgical tool (guiding catheter) is introduced. In order to generate a more accurate three-dimensional image of the tissues of the subject (patient undergoing surgery), image processing optimization and correction (complementation) are required.

[0036] Therefore, when generating three-dimensional spatial data based on tomographic images, the image is not simply converted into three dimensions; tomographic images of tissue regions of multiple other subjects are utilized as information (data) for optimizing and correcting (complementing) image processing. In this case, tomographic images of coronary arteries of the heart acquired by other users' tomographic imaging devices 20 (e.g., X-ray CT) are acquired extensively and serve as a reference for variations in shape, size, etc. These tomographic images are positioned as training data, and machine learning using artificial intelligence (AI) is repeated to improve the accuracy and refinement of the three-dimensional spatial data generated from the tomographic images, as well as the precision of the representation of details.

[0037] The machine learning method is not particularly limited as long as it is suitable for generating three-dimensional spatial data (three-dimensional images). For example, methods such as support vector machines, logistic regression, random forests, forward propagation neural networks, recurrent neural networks, convolutional neural networks, and k-nearest neighbor methods can be used.

[0038] The spatial feature detection unit 120 recognizes the shape of the aorta, pulmonary artery, inferior vena cava, left atrium, right atrium, or intracardiac valves as the target region of the subject, or the position of the inlet of a treatment target blood vessel or intracardiac structure, from the three-dimensional spatial data, and detects spatial features of the space into which a surgical tool is introduced (spatial features of the space related to the introduction of a surgical tool). The target region is a region of the coronary artery of the cardiac blood vessels that needs to be grasped when introducing a surgical tool (guiding catheter). It also includes the inlet of the blood vessel (the inlet of the treatment target blood vessel, the branching portion of the blood vessel), and other blood vessels along the way when introducing the surgical tool (guiding catheter). In other words, the target region includes both the cardiac blood vessel that requires actual catheter treatment and the aorta, pulmonary artery, and inferior vena cava that exist between the target blood vessel and the target heart vessel and pass through the catheter. The target region also includes the shape of the left atrium, right atrium, or intracardiac valves required for procedures such as percutaneous left atrial appendage closure, as well as the inlet of the treatment target blood vessel or intracardiac structure, such as the left atrial appendage. Furthermore, spatial characteristics are characteristics of the spatial shape of blood vessels and tissues that allow a surgical tool to be safely introduced into blood vessels, etc. Furthermore, the space into which a surgical tool is introduced (space related to the introduction of a surgical tool) includes not only the treatment site where the surgical tool is introduced and treated, but also the site through which the surgical tool passes before reaching the treatment site.

[0039] Then, a target region formed from the three-dimensional spatial data is identified, and the shapes of the aorta and coronary artery ostia, which serve as the path for introducing surgical tools (the path of the surgical tools), as well as the position of the ostia of the blood vessel to be treated and the left atrial appendage ostia 78 (see Figures 11 and 12 below), which is the boundary region of the left atrial appendage 77 that connects to the left atrium 74, are recognized. A known image analysis method for shape recognition is used for shape recognition. Furthermore, to improve accuracy, machine learning using the aforementioned artificial intelligence (AI) is used.

[0040] Based on the spatial characteristics, the measurement unit 130 measures one or more (preferably multiple) angles and distances for introducing a surgical tool into the subject's tissue, as well as the opening diameter of the left atrial appendage entrance 78. In this measurement, multiple approach angles for introducing a surgical tool and distances between vascular walls, etc. are measured (calculated by simulation) from the shapes of blood vessels, branching portions, etc. contained in the three-dimensional spatial data of the target region of the subject. In addition, the opening diameter of the left atrial appendage entrance 78 is measured, and a left atrial appendage closure device of a size corresponding to the measured opening diameter of the left atrial appendage entrance 78 is selected.

[0041] The presentation unit 140 presents the shape of a surgical tool suitable for introduction into the subject's tissue based on one or more (preferably multiple) angles and distances measured by the measurement unit 130. The presentation unit 140 also presents the size of the surgical tool when presenting the surgical tool. Furthermore, the presentation unit 140 acquires shape information for each of multiple types of surgical tools expected to be introduced into the subject's target region, compares the shape information with one or more (multiple) angles and distances measured by the measurement unit 130, and presents one or more surgical tools from the multiple types of surgical tools that are suitable for introduction into the subject's target region based on the comparison. The method of presenting a surgical tool suitable for introduction into the subject's target region may involve presenting the specific shape and dimensions of the surgical tool, or may involve presenting the model number of the suitable surgical tool.

[0042] Surgical tools to be introduced into tissues are available in a variety of shapes and sizes to match the size and shape of the target tissue. In the case of the guiding catheter of the embodiment, there is a wide range of tip shapes (degree of curvature, position of the bending point), thicknesses (tube diameter), etc. Surgical tools such as left atrial appendage closure devices also vary in size and specifications. Furthermore, there are differences depending on the manufacturer of the guiding catheter, left atrial appendage closure device, and other surgical tools. Therefore, when using a surgical tool, it is necessary to accurately understand the differences in the shape of the surgical tool and the inventory of the surgical tool.

[0043] Because there are an increasing number of types of surgical tools, such as guiding catheters and left atrial appendage closure devices, in order to automate the identification and management of surgical tools, shape information of the surgical tools is acquired through the presentation unit 140. Specifically, information on the model number, article number, manufacturer name, shape, size, and specifications of surgical tools, such as guiding catheters and left atrial appendage closure devices, that are in stock and stored in medical facilities capable of performing surgery is input or acquired (input) by transmission from the manufacturer, and stored in the memory unit 14 of the computer 10 or an external server (not shown), etc.

[0044] The presentation unit 140 measures the tissue region image generated within the three-dimensional image, compares it with the shape information, and, based on the comparison, presents a surgical tool of a size and shape suitable for introduction into the target region (tissue) of the subject from among multiple types of surgical tools. The measurement results can be used to confirm and compare the shape and size of the surgical tool (guiding catheter, left atrial appendage closure device) acquired in advance. When comparing the tissue measurement results with the surgical tool, for example, the inner diameter of the target region (coronary artery) into which the surgical tool will actually be introduced is measured from three-dimensional spatial data. A predetermined clearance is then set, and the amount obtained by subtracting this clearance from the inner diameter of the insertion site is determined, which becomes the maximum allowable cross-sectional diameter of the surgical tool (guiding catheter). Therefore, surgical tools with diameters that match or are less than the maximum allowable diameter are compared. Furthermore, the degree of bending and curvature of the tip of the surgical tool (guiding catheter) is estimated and compared by simulation based on the angle at which the coronary artery connected to the aorta branches, whether the surgical tool (guiding catheter) is long enough to pass through the branching site, and whether there is a steric obstruction. In addition, a number of surgical tools (guiding catheters) of different shapes and sizes may be introduced, and a three-dimensional image based on the three-dimensional spatial data may be prepared by simulating different degrees of insertion, and the three-dimensional image may be used to verify the suitability of the surgical tool. The presentation unit 140 may also be used to verify the suitability of a left atrial appendage closure device to be applied to the left atrial appendage 77 in Figures 11 and 12 described below.

[0045] FIG. 5 shows an example of a simulation image of introducing a surgical tool into tissue. The simulation image shows the introduction of a guiding catheter 30, a surgical tool, into a three-dimensional image 60 based on three-dimensional spatial data of the aorta of the heart and the left or right coronary artery. In the figure, the sizes of the aorta and the coronary artery ostium, which are target regions of the subject (patient) into which the guiding catheter 30 is introduced, are measured by the measurement unit 130 from the three-dimensional spatial data. In the figure, the measurement results can be calculated and displayed as arrows of size S1 and size S2. Based on these measurement results, both the guiding catheter 30a and the guiding catheter 30b are displayed. Therefore, the three-dimensional image allows the three-dimensional distance between the tissue and the surgical tool to be displayed. The simulation image of the embodiment is useful for the surgeon to consider the path when introducing the guiding catheter into the coronary artery.

[0046] At the same time, because it is possible to calculate stereoscopic (three-dimensional) measurement results for each location based on a three-dimensional image of the subject's (patient's) tissue, it is possible to estimate the optimal size and shape of the surgical tool from the measurement results. That is, based on the measurement dimensions of each location in the virtual reality (VR) three-dimensional image of the blood vessel, the shape and size information of the surgical tool (guiding catheter) acquired by the aforementioned presentation unit 140 is sequentially collated. Then, a guiding catheter with sufficient slack for safe introduction is automatically estimated. The estimated surgical tool (guiding catheter) is then presented as a surgical tool with a size and shape suitable for introduction into the subject's tissue.

[0047] 6 is a schematic diagram showing one method for defining the size of the surgical tool in the presentation unit 140. The structure of the tip of the surgical tool 30 (guiding catheter) is generally composed of three parts: a main body 35, a bending part 36, and a hook 37. The main body 35, the bending part 36, and the hook 37 each have different sizes (lengths) and different angles at which they are connected to one another. The number of types of guiding catheters inevitably increases depending on the combination of sizes and angles.

[0048] Therefore, when selecting a surgical tool that matches or is suitable for the target site for insertion of the surgical tool, the length L1 of the hook 37, the length L3 of the bending portion 36, and the length L2 of the main body 35 (the range of motion of the guiding catheter) are used, as shown in Figure 6. Furthermore, the bending angle φ1 between the bending portion 36 and the hook 37, and the bending angle φ2 between the main body 35 and the bending portion 36 are used.

[0049] For example, the surgical tool 30 (guiding catheter) disclosed in the figures can be classified according to the structure of the tip using a relatively small number of indicators for the length and angle of the portion. Therefore, by comparing the length and angle indicators that identify the basic structure of the surgical tool with the size (inner diameter) and shape of the tissue (blood vessel) identified from the tissue region image generated in the three-dimensional image based on the three-dimensional spatial data, it becomes easy to present (select) the degree of compatibility between one or more angles and distances measured by the measurement unit 130 and the shape information of the surgical tool 30 (guiding catheter) that is more suitable for the tissue structure.

[0050] Regarding the selection of the surgical tool 30 (guiding catheter), for example, when a backup-type catheter (e.g., EBU, SPB, BL, etc.) is to be introduced into the left coronary artery, the following calculation is performed (see FIGS. 10A and 10B ). First, a line (A) is set that is the shortest distance between the center line ax of the aorta Aor and the entrance of the left coronary artery Lca. Then, the line (A) is extended into the coronary artery, and the position of the intersection (α) with the coronary artery wall is calculated. From the position of the intersection (α), a line is further set that is inclined at, for example, 35° with respect to the line (A). From multiple candidates for the inclined line, a line (B) that has the longest distance to the contact point with the contralateral aortic wall is set, and the length (L) of the line (B) is calculated (see FIG. 10A ).

[0051] A line (X) is calculated that forms a 35° angle from the tangent (Y) set at the tip of the catheter from the tip (e) of the backup-type catheter shape described above, and the length (L') from the catheter tip of the line (X) to the catheter portion on the opposite side is measured (see Figure 10 (B)). The length (L') is determined by the size of the catheter. Ready-made sizes are graded. For example, sizes are specified such as Hyperion SPB 3.0, 3.5, 3.75, 4.0, etc. The length (L') is determined according to each size. The catheter with the length (L') that is closest in value to the length (L) is the recommended catheter.

[0052] This makes it easier for surgeons to select from a variety of surgical instruments (guiding catheters). It also ensures objectivity in the selection of surgical instruments. Therefore, the surgical support device reduces the burden on medical facilities and their physicians when selecting surgical instruments, even for those with a low volume of surgeries.

[0053] Furthermore, the presenting unit 140 measures a tissue region image generated within a three-dimensional image based on the three-dimensional spatial data, compares it with shape information, and based on the comparison, presents one or more surgical tools from among multiple types of surgical tools that have a size and shape suitable for introduction into the subject's tissue. In addition, when presenting multiple surgical tools that have a size and shape suitable for introduction into the subject's tissue, the presenting unit 140 presents the multiple surgical tools by ranking them based on the similarity of their shape to the tissue region image.

[0054] As mentioned above, there are many types of surgical tools, such as guiding catheters, available with subtle differences in shape. However, there are cases where a surgical tool (guiding catheter) of the presented shape and size is not available in the inventory of surgical tools at the surgical site where it will actually be inserted into the patient's affected area, or where it is difficult to procure it from a nearby medical facility. In such cases, it is necessary to select a surgical tool with an approximate shape as a second-best option. Therefore, based on the shape information acquired and accumulated by the presentation unit 140, multiple surgical tools are presented, such as a best choice surgical tool, a second choice of a surgical tool with an approximate shape that is available in stock, and a third choice of a surgical tool with the next closest shape that is available in stock.

[0055] In this case, the most important condition is the similarity of the shape to the tissue region image of the subject (patient), and the ranking is performed taking into account inventory confirmation. If procurement from another medical facility or from the instrument manufacturer is possible, the ranking may be performed taking into account ease of procurement. For example, in the example of the schematic diagram in FIG. 1, multiple (three in the figure) guiding catheters are shown as the surgical tool 30. Therefore, it is assumed that the guiding catheters will be presented in the following order: 32, 33, 31.

[0056] The presentation unit 140 generates guidance information that guides the introduction of a surgical tool of a size and shape appropriate for introduction into a target region of the subject. Additionally, the presentation unit 140 presents a reference direction, a direction within the coronary artery, and an angle that serve as a basis for determining the direction of introduction of the surgical tool into the target region. The guidance information at this time displays the reference direction, direction within the coronary artery, and angle for introducing the surgical tool into the subject's tissue, along with a three-dimensional image based on three-dimensional spatial data. The surgical support device of the embodiment not only presents (suggests) the optimal surgical tool as described above, but also supports the surgeon in surgery by showing how to use the presented surgical tool.

[0057] The reference direction is a direction presented based on the shape of the aortic valve or the sinus of Valsalva at the target site. When a surgical tool (guiding catheter) is finally introduced into the coronary artery, the surgical tool obviously passes through the aortic valve and the sinus of Valsalva along the way. Since the internal structure and size of the heart, such as the aortic valve and the sinus of Valsalva, are known in advance from an analysis of the tissue region image, a surgical tool orientation that does not damage the internal tissue can be determined based on the internal structure and size of the aortic valve, the sinus of Valsalva, and the shape of the surgical tool itself, and a suitable direction for passing through the aortic valve and the sinus of Valsalva can be determined. For example, the reference direction can be defined as an axial direction connecting the aortic inlet site where the surgical tool (guiding catheter) is introduced and the center of the aortic valve, or an axial direction connecting the aortic inlet site and the center of gravity of the sinus of Valsalva.

[0058] As an example, an image example is shown in Figure 7. In the figure, a three-dimensional image 60 based on three-dimensional spatial data of the aorta and coronary arteries of the heart is displayed as the tissues of the subject, and a state in which a guiding catheter 30 is introduced as a surgical tool from the aorta is shown within the three-dimensional image 60 of the coronary artery. In the figure, the guidance information is displayed as an arrow, and the direction of the arrow indicates the direction in the coronary artery in which the tip of the guiding catheter 30 should be advanced. Since the direction in the coronary artery, such as an arrow, is superimposed on the three-dimensional image as guidance information, the surgeon can imagine in advance the state of the patient's tissues and the sensation of introducing the surgical tool, and also, information on the progress of the surgery can be smoothly shared among other doctors, trainees, etc.

[0059] In addition, as in the example image of Fig. 7, each arrow displays the angle when introducing the surgical tool, such as θ1, θ2, etc. The display mode is appropriate, and guidance information may be displayed first indicating the angle of introduction of θ1, followed by the angle of θ2, or guidance information may be displayed as a candidate for selecting either θ1 or θ2.

[0060] Finally, various information, such as the target tissue, surgical instruments, and surgical strategy, is aggregated. For example, as shown in the example image of Figure 8, a three-dimensional image 60 is generated in which the coronary artery tissue is separated from the heart of the patient scheduled for surgery, and the guiding catheter 30 to be introduced into the coronary artery is shown. For detailed confirmation, example images of the main parts, such as those in Figures 5 and 7, are referenced. Thus, the surgeon can easily visualize the PCI treatment strategy by recognizing the stenotic location within the coronary artery from the three-dimensional image. Although not shown, other information necessary for surgery, such as the treatment branch (RCA, etc.) within the branched coronary artery, the shape of the guiding catheter (AL system), and backup, is also aggregated and centrally managed. For example, this system is expected to be useful for treatment in remote locations.

[0061] As explained above, surgical tools such as guiding catheters are available in a wide variety of shapes and sizes, and medical facilities are required to maintain a wide variety of inventory at all times and adapt to each patient's surgical procedure. Obviously, maintaining inventory is a heavy burden, and unused tools are discarded due to the sterilization warranty period. In this embodiment, measurements based on the three-dimensional spatial data of the tissue generated by the three-dimensional spatial data generator 110 described above enable the sequential selection of a surgical tool that best suits the subject's tissue before surgery. In other words, it is possible to determine the most user-friendly guiding catheter that matches the shape of each patient's coronary artery. Furthermore, the creation of the most user-friendly guiding catheter, which is custom-made for each patient, is also within the realm of possibility.

[0062] Therefore, a surgical tool processing unit 40 is added to the surgery support device 1. The surgical tool processing unit 40 is a processing device that processes the shape of a surgical tool into a shape suitable for introduction into the tissue of a subject, based on the tissue region image.

[0063] 9(A) is a cutaway perspective view of an example of a surgical tool processing unit 40. The surgical tool processing unit 40 includes a case 41 that is kept sterile to process surgical tools such as a guiding catheter, and a processing jig 42 housed inside the case 41. A heating unit 43 is provided for heating the jig 42. The jig 42 is made of metal and has multiple grooves, protrusions, etc., suitable for bending the surgical tool. Because the guiding catheter is made of resin, contact with the grooves in the jig 42 results in a suitable amount of bending. A known heating device such as an electric heating wire or an induction heater is used for the heating unit 43.

[0064] 9(B), the guiding catheter 30 is held and processed by a robot arm 50. As shown in the figure, the robot arm 50 is provided with a pair of gripping portions 51 and 52, which accurately hold the bending portion of the guiding catheter 30.

[0065] When the surgical support device 1 is equipped with a surgical tool processing unit 40, a processing amount calculation unit 150 is added as a functional unit of the calculation unit 11 of the computer 10. Accurate and precise three-dimensional shape and measurement are possible from the tissue region image described above. Furthermore, information on one or more angles and distances of the target region of the subject measured by the measurement unit 130 can be utilized. The processing amount calculation unit 150 calculates the difference in shape between the guiding catheter before processing and the guiding catheter after processing, and calculates the bending location and degree of bending in the surgical tool as the processing amount. The processing amount calculation unit 150 also converts this information (processing amount) into a motion control amount for the robot arm 50. Processing into the guiding catheter is then performed in the surgical tool processing unit 40 under the control of the calculation unit 11 of the computer 10.

[0066] The processed and finished guiding catheter 30 can be used in surgery as is or stored for a later surgery, etc. In non-urgent cases, the necessary guiding catheters can be processed in bulk at a nearby medical facility and delivered.

[0067] An output unit 160 is further added as a functional unit of the calculation unit 11 of the computer 10. The output unit 150 performs data processing necessary for outputting the generated three-dimensional image and the presented surgical tool (its type, etc.) from the computer 10 (I / O 15). Furthermore, the output unit 160 prepares the data to be sent to the surgical tool processing unit 40.

[0068] The surgery support device 1 of the embodiment can be applied to support the selection of a guiding catheter to be introduced into a coronary artery, as illustrated and described above. In addition, the surgery support device 1 of the embodiment can be applied to support the placement of a surgical tool, such as a left atrial appendage closure device, in the left atrial appendage of the heart. The schematic diagrams (simulation images) of Figures 11 and 12 are images (simulation images) generated by capturing images of a subject's chest using the tomography device 20 (see Figure 1), and show the state of percutaneous left atrial appendage closure (LAAC).

[0069] 11 shows a longitudinal cross section of a heart 70, including cross sections of the right ventricle 71, left ventricle 72, right atrium 73, and left atrium 74, as well as the aorta 75, superior vena cava 76, and inferior vena cava 79. The left atrial appendage 77 is a sac-like region that protrudes from the left atrium 74 outward from the heart 70. Thrombi are likely to form in the left atrial appendage 77, and these thrombi may travel through the bloodstream and block cerebral blood vessels, potentially causing cerebral infarction. Therefore, percutaneous left atrial appendage closure is a procedure that blocks the left atrial appendage 77 and inhibits thrombus formation.

[0070] 12 , a surgical catheter is inserted through the inferior vena cava 79 and enters the left atrium 74 by puncturing the atrial septum. A left atrial appendage closing device 81 mounted on a catheter 80 then expands around a left atrial appendage inlet 78 (shown by a dashed line in the figure) at the boundary of the left atrial appendage 77 that connects to the left atrium 74. The atrial appendage closing device 81 is detached from the catheter 80 and placed at the left atrial appendage inlet 78, thereby closing the sac-like left atrial appendage 77.

[0071] When closing the left atrial appendage 77, a left atrial appendage closing device is selected as the surgical tool to match the size (opening diameter) of the left atrial appendage ostium 78. At this time, inserting and removing (replacing) a catheter equipped with a left atrial appendage closing device to match the size of the left atrial appendage ostium 78 wastes materials and surgical time. Therefore, the opening diameter of the subject's left atrial appendage ostium 78 is determined in advance from simulation images and image analysis, and a catheter 80 equipped with a left atrial appendage closing device 81 that is compatible with the target left atrial appendage ostium 78 is selected. As a result, the efficiency of the surgical procedure is improved.

[0072] Next, a surgical assistance method and a surgical assistance program for the surgical assistance device 1 of the embodiment will be described using the flowcharts in Figures 13 and 14. The surgical assistance method is executed by the calculation unit 11 of the computer 10 based on the surgical assistance program. The surgical assistance program causes the computer 10 of Figures 1 and 2 to execute a three-dimensional space data generation function, a spatial feature detection function, a measurement function, a presentation function, an output function, and the like. When the surgical tool processing unit 40 is connected, the surgical assistance program also executes a processing amount calculation function. Each function overlaps with the description of the surgical assistance device 1 described above, so details will be omitted.

[0073] As shown in the flowchart of FIG. 11, the processing of the calculation unit 11 of the computer 10 includes various steps, such as a three-dimensional space data generation step (S110), a space feature detection step (S120), a measurement step (S130), a presentation step (S140), and an output step (S160).

[0074] The three-dimensional spatial data generation function acquires tomographic images of the subject's chest tissue and generates three-dimensional spatial data of the tissue from the tomographic images (S110; three-dimensional spatial data generation step). The spatial feature detection function recognizes the shape of the subject's target area, such as the aorta, pulmonary artery, inferior vena cava, left atrium, right atrium, or intracardiac valves, or the location of the inlet of the target blood vessel or intracardiac structure, from the three-dimensional spatial data, and detects spatial features of the space into which the surgical tool will be introduced (S120; spatial feature detection step). The measurement function measures one or more angles and distances for introducing the surgical tool into the subject's tissue based on the spatial features (S130; measurement step). The presentation function presents the shape of the surgical tool suitable for introduction into the subject's tissue based on the one or more angles and distances (S140; presentation step). The output function sets the data required for output (S160; output step).

[0075] The flowchart in Figure 12 shows the flow of processing in the surgery support device 1 to which the surgical tool processing unit 40 is connected. As shown in the figure, the processing of the calculation unit 11 of the computer 10 includes various steps, such as a three-dimensional space data generation step (S110), a spatial feature detection step (S120), a measurement step (S130), a presentation step (S140), a processing amount calculation step (S150), and an output step (S160). The processing amount calculation function calculates the difference in shape between the surgical tool (guiding catheter) before processing and the surgical tool after processing, and converts information on this difference into a processing amount and a motion control amount for the robot arm.

[0076] The above-mentioned computer program may be recorded on a processor-readable recording medium, and the recording medium may be a "non-transitory tangible medium" such as a tape, disk, card, semiconductor memory, programmable logic circuit, etc.

[0077] The computer program can be implemented using, for example, a scripting language such as ActionScript or JavaScript (registered trademark), an object-oriented programming language such as Objective-C or Java (registered trademark), or a markup language such as HTML5.

[0078] REFERENCE SIGNS LIST 1 Surgery support device 10 Computer (information processing device) 11 Calculation unit 12 ROM 13 RAM 14 Storage unit 15 I / O 16 Display 20 Tomographic imaging device 30, 30a, 30b, 31, 32, 33 Surgical tool (guiding catheter) 40 Surgical tool processing unit 41 Case unit 42 Jig 43 Heating unit 50 Robot arm 51, 52 Grasping unit 60 Three-dimensional space data 80 Catheter 81 Left atrial appendage closure device 110 Three-dimensional space data generation unit 120 Spatial feature detection unit 130 Measurement unit 140 Presentation unit 150 Processing amount calculation unit 160 Output unit

Claims

1. A surgical assistance device comprising: a three-dimensional spatial data generation unit that acquires tomographic images of the chest tissue of a subject and generates three-dimensional spatial data of the tissue from the tomographic images; a spatial feature detection unit that recognizes the shape of the aorta, pulmonary artery, inferior vena cava, left atrium, right atrium, or intracardiac valves as the subject's target part from the three-dimensional spatial data, or the position of the entrance of the blood vessel or intracardiac structure to be treated, and detects spatial features of the space into which a surgical tool is to be introduced; a measurement unit that measures one or more angles and distances for introducing the surgical tool into the subject's tissue based on the spatial features; and a presentation unit that presents the shape of the surgical tool suitable for introduction into the subject's tissue based on the one or more angles and distances.

2. A surgical assistance device as described in claim 1, wherein the spatial feature detection unit presents a reference direction that serves as a reference for determining the direction in which the surgical tool is introduced into the target area.

3. The surgical assistance device according to claim 2, wherein the reference direction is presented based on the shape of the aortic valve or the sinus of Valsalva in the target area.

4. A surgical support device as described in claim 1, wherein the presentation unit presents the size of the surgical tool when presenting the surgical tool.

5. The surgical support device of claim 1, wherein the presentation unit acquires shape information for each of multiple types of surgical tools that are expected to be introduced into the target area, compares the one or more angles and distances with the shape information, and, based on the comparison, presents one or more of the multiple types of surgical tools that are suitable for introduction into the target area of ​​the subject.

6. A surgical support device as described in claim 5, wherein the presentation unit presents a plurality of surgical tools suitable for insertion into the target area of ​​the subject by ranking the surgical tools based on the degree of compatibility with the one or more angles and distances.

7. A surgical support device as described in claim 1, wherein the presentation unit generates guidance information for guiding the introduction of the surgical tool suitable for introduction into the target part of the subject into the target part of the subject.

8. A surgical support device as described in claim 7, wherein the presentation unit displays, as the guidance information, a three-dimensional image of the surgical tool to be introduced into the target area of ​​the subject, along with the angle at which the surgical tool will be introduced.

9. A surgical support device as described in claim 1, wherein the spatial feature detection unit acquires tomographic images of the chest tissues of multiple other subjects as training data, performs machine learning, and detects the spatial features of the space into which a surgical tool is introduced from the target area of ​​the subject.

10. A surgical support device according to claim 1, wherein the target area of ​​the subject is a coronary artery of the heart, and the surgical tool is a catheter.

11. A surgical support apparatus according to claim 1, wherein the target area of ​​the subject is the left atrial appendage of the heart, and the surgical tool is a device for closing the left atrial appendage.

12. A surgical assistance device as described in claim 1, which is connected to a surgical tool processing unit that processes the shape of the surgical tool into a shape suitable for introduction into the target area of ​​the subject based on the one or more angles and distances.

13. A surgical support device as described in claim 12, wherein the surgical tool processing unit comprises a heating unit that heats the catheter, which is the surgical tool, and a gripping unit that grips the catheter.

14. A surgical assistance method characterized by the computer executing the following steps: a three-dimensional spatial data generation step of acquiring tomographic images of the chest tissue of a subject and generating three-dimensional spatial data of the tissue from the tomographic images; a spatial feature detection step of recognizing from the three-dimensional spatial data the shape of the aorta, pulmonary artery, inferior vena cava, left atrium, right atrium, or intracardiac valves as the subject's target area, or the position of the entrance of a blood vessel or intracardiac structure to be treated, and detecting spatial features of the space into which a surgical tool is to be introduced; a measurement step of measuring one or more angles and distances for introducing the surgical tool into the subject's tissue based on the spatial features; and a presentation step of presenting the shape of a surgical tool suitable for introduction into the subject's tissue based on the one or more angles and distances.

15. A surgical assistance program that causes a computer to implement the following: a three-dimensional spatial data generation function that acquires tomographic images of the chest tissue of a subject and generates three-dimensional spatial data of the tissue from the tomographic images; a spatial feature detection function that recognizes the shape of the aorta, pulmonary artery, inferior vena cava, left atrium, right atrium, or intracardiac valves as the subject's target area from the three-dimensional spatial data, or the position of the entrance of the blood vessel or intracardiac structure to be treated, and detects spatial features of the space into which a surgical tool is to be introduced; a measurement function that measures one or more angles and distances for introducing a surgical tool into the subject's tissue based on the spatial features; and a presentation function that presents the shape of a surgical tool suitable for introduction into the subject's tissue based on the one or more angles and distances.

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