Navigation device and navigation method

Abstract

To output information about three-dimensional position information of a ventricular septum in a simpler method in comparison to a system that uses a conventional electrophysiological mapping method.SOLUTION: A navigation device comprises: an image acquisition unit which images a ventricular septum of the heart while changing the imaging position of an FPD to acquire a plurality of images including the ventricular septum; a ventricular septum information acquisition unit which acquires ventricular septum information being information about the orientation and position of the ventricular septum by using the plurality of images; a device position information acquisition unit which acquires position information of a medical device inserted to the heart; a position estimation unit which estimates three-dimensional position information of the ventricular septum by using the ventricular septum information and the position information of the medical device; and an output control unit which outputs information about the three-dimensional position information of the ventricular septum.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a navigation device and a navigation method. [Background technology]

[0002] As the population ages, the number of patients with heart failure is increasing. Traditionally, surgical transplantation was used to treat heart failure, but in recent years, development of regenerative medicine techniques that do not involve transplantation has progressed. One of the regenerative medicine techniques that does not involve transplantation is known as drug injection therapy. In drug injection therapy, new blood vessels are promoted by injecting a drug solution containing bFGF (basic fibroblast growth factor), VEGF (vascular endothelial growth factor), HGF (hepatocyte growth factor), etc. into the myocardium.

[0003] Injection of a drug solution into the myocardium constituting the outer wall of the ventricle can be performed using a drug solution injection device inserted into the coronary artery, similar to the conventional percutaneous coronary intervention (PCI) procedure. On the other hand, injection of a drug solution into the ventricular septum requires the device for drug solution injection to reach the inside of the ventricle, so there has been a demand for grasping the position of the ventricular septum in order to perform this procedure easily and reliably. In this regard, Patent Document 1 discloses a technique for superimposing the actually measured electrocardiogram signal amplitude on an anatomical map of the heart. Patent Document 2 discloses a technique for displaying an anatomical model of the heart and source information (dipole density information, surface charge information, temperature information, pH information) corresponding to cardiac activity. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2020-99689 A [Patent Document 2] JP 2020-124582 A Summary of the Invention [Problem to be solved by the invention]

[0005] However, the systems described in Patent Documents 1 and 2 use an electrophysiological mapping method, and therefore have a problem in that it takes time to identify the position of each part of the heart, and as a result, it takes time to display an anatomical map or model of the patient's heart. Note that this problem is not limited to the case of injecting a medicinal liquid into the ventricular septum, but is also common to the case of injecting a medicinal liquid from inside the ventricle into the myocardium that constitutes the outer wall of the ventricle.

[0006] The present invention has been made to solve at least part of the above-mentioned problems, and aims to make it possible to output information regarding the three-dimensional positional information of the ventricular septum in a simpler manner than systems using conventional electrophysiological mapping techniques. [Means for solving the problem]

[0007] The present invention has been made to solve at least part of the above-mentioned problems, and can be realized in the following forms.

[0008] (1) According to one aspect of the present invention, there is provided a navigation device comprising: an image acquisition unit that images the ventricular septum of the heart while changing an imaging position of an FPD (flat panel detector) to acquire a plurality of images including the ventricular septum, a ventricular septum information acquisition unit that acquires ventricular septum information, which is information regarding the orientation and position of the ventricular septum, using the plurality of images, a device position information acquisition unit that acquires position information of a medical device inserted into the heart, a position estimation unit that estimates three-dimensional position information of the ventricular septum using the ventricular septum information and the position information of the medical device, and an output control unit that causes information regarding the three-dimensional position information of the ventricular septum to be output.

[0009] According to this configuration, the ventricular septum information acquisition unit can acquire information on the orientation and position of the ventricular septum (ventricular septum information) without using a conventional electrophysiological mapping method by using multiple images acquired while changing the imaging position of the FPD. Furthermore, the position estimation unit can estimate three-dimensional position information of the ventricular septum by using this ventricular septum information and position information of a medical device inserted into the heart, without using a conventional electrophysiological mapping method. In other words, according to the navigation device of this configuration, it is possible to estimate three-dimensional position information of the ventricular septum and output information on the three-dimensional position information of the ventricular septum in a simpler manner than a system using a conventional complex electrophysiological mapping method.

[0010] (2) In the navigation device of the above embodiment, the ventricular septum information acquisition unit may designate an image among the plurality of images in which the area of ​​the ventricular septum is represented as the largest as a specific image, and may obtain the ventricular septum information from the imaging position of the FPD when the specific image was captured. According to this configuration, the ventricular septum information acquisition unit obtains ventricular septum information from the imaging position of the FPD when a specific image showing the largest area of ​​the ventricular septum is captured, among a plurality of images obtained while changing the imaging position of the FPD. In other words, the ventricular septum information acquisition unit can obtain information on the orientation and position of the ventricular septum (ventricular septum information) in a simpler manner by linking the orientation and position of the ventricular septum with the imaging position of the FPD.

[0011] (3) In the navigation device of the above embodiment, the position estimation unit may estimate three-dimensional position information of the ventricular septum by identifying one plane from multiple planes having a perpendicular line aligned with a specific axis passing through the centers of the X-ray tube assembly and the X-ray detector of the FPD when the specific image was captured, using position information of the medical device. According to this configuration, the position estimation unit can easily estimate three-dimensional position information of the ventricular septum by using position information of the medical device to identify one plane from multiple planes having a perpendicular line aligned with a specific axis passing through the centers of the X-ray tube assembly and the X-ray detector of the FPD when the specific image is captured.

[0012] (4) In the navigation device of the above aspect, the output control unit may output an image in which a first image indicating a three-dimensional position of the ventricular septum is superimposed on an image of the heart captured by the FPD. According to this configuration, the output control unit outputs an image in which the first image, which indicates the three-dimensional position of the ventricular septum, is superimposed on the image of the heart captured by the FPD. Therefore, according to the navigation device of this configuration, it is possible to guide the three-dimensional position of the ventricular septum using an actual image of the patient's heart.

[0013] (5) In the navigation device of the above embodiment, the output control unit may output an image in which a second image representing a target position within the ventricular septum into which medicinal liquid should be injected is superimposed on the image of the heart captured by the FPD. According to this configuration, the output control unit outputs an image in which a second image showing a target position in the ventricular septum where the medicinal liquid should be injected is superimposed on an image of the heart captured by the FPD. Therefore, according to the navigation device of this configuration, the target position where the medicinal liquid should be injected can be guided using an actual image of the patient's heart.

[0014] (6) In the navigation device of the above aspect, the output control unit may further output the image on which a third image showing a position of a tip of the medical device inside the heart is superimposed. According to this configuration, the output control unit further outputs an image on which a third image showing the position of the tip of the medical device in the heart is superimposed. Therefore, according to the navigation device of this configuration, it is possible to use an image of the actual patient's heart to guide the position to which the tip of the medical device should be directed (i.e., at least one of the three-dimensional position of the ventricular septum and the target position to which the medicinal liquid should be injected) and the current position of the tip of the medical device.

[0015] The present invention can be realized in various forms, for example, in the form of an information processing device, an FPD (flat panel detector) capable of displaying three-dimensional position information of the ventricular septum, a system including these devices, a computer program that realizes the functions of these devices and systems, a server device for distributing the computer program, a non-transitory storage medium on which the computer program is stored, etc. [Brief description of the drawings]

[0016] [Figure 1] FIG. 1 is an explanatory diagram illustrating a configuration of a medical system. [Diagram 2] FIG. 1 is an explanatory diagram illustrating a configuration of a medical system. [Diagram 3] 13 is a flowchart illustrating an example of an output process. [Figure 4] FIG. 11 is a diagram illustrating step S14 of the output process. [Diagram 5] FIG. 11 is a diagram illustrating step S16 of the output process. [Figure 6] FIG. 11 is a diagram illustrating step S20 of the output process. [Figure 7] FIG. 11 is a diagram illustrating step S24 of the output process. [Figure 8] FIG. 13 is a diagram showing an example of an image displayed in step S30 of the output process. [Figure 9] FIG. 11 is a diagram showing another example of the image displayed in step S30 of the output process. [Figure 10] 13 is a flowchart illustrating an example of an output process according to the second embodiment. [Figure 11] FIG. 13 is a diagram illustrating step S30A of the output process. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] First Embodiment 1 and 2 are explanatory diagrams illustrating an example of the configuration of a medical system 1. The medical system 1 is a system used for treatment or diagnosis of a living body (here, a human body) 90, and can output information related to three-dimensional position information of the ventricular septum of a heart 91. An operator can easily perform a liquid medicine injection treatment using the information output by the medical system 1. The liquid medicine injection treatment is a treatment for heart failure, for example, that promotes angiogenesis by injecting a liquid medicine containing bFGF (basic fibroblast growth factor), VEGF (vascular endothelial growth factor), HGF (hepatocyte growth factor), or the like. The medical system 1 includes a navigation device 10, a blood vessel imaging device 20 having an FPD (flat panel detector), a display device 30, a table 40, an operation unit 50, a magnetic sensor array 60, and a medical device 70.

[0018] 1 and 2 show mutually orthogonal X, Y and Z axes. The X axis corresponds to the width direction of the blood vessel imaging device 20, the Y axis corresponds to the height direction of the blood vessel imaging device 20, and the Z axis corresponds to the depth direction of the blood vessel imaging device 20. In the following explanation, the direction in which the head 92 of the patient (human body 90 in FIG. 1) is located is also referred to simply as the "Z-axis direction" and simply represented as "Z".

[0019] In an output process described later, the navigation device 10 estimates three-dimensional position information of the ventricular septum of the heart 91 and outputs the information to the display device 30. The navigation device 10 includes a CPU, a ROM, and a RAM, and the CPU executes a computer program stored in the ROM to realize the functions of a main control unit 11, an image acquisition unit 12, a ventricular septum information acquisition unit 13, a device position information acquisition unit 14, a position estimation unit 15, and an output control unit 16. As shown in Figs. 1 and 2, the navigation device 10 is electrically connected to each of the control unit 29, the display device 30, the operation unit 50, the magnetic sensor array 60, and the medical device 70 of the blood vessel imaging device 20.

[0020] The main control unit 11 transmits and receives information to and from the control unit 29 of the blood vessel imaging device 20, the display device 30, the operation unit 50, the magnetic sensor array 60, and the medical device 70, and also controls the entire navigation device 10. The main control unit 11 also controls the entire output processing, which will be described later.

[0021] In the output process, the image acquisition unit 12 acquires each of the multiple images captured by the blood vessel imaging device 20. In the output process, the ventricular septum information acquisition unit 13 acquires ventricular septum information. Here, "ventricular septum information" means information about the orientation and position of the ventricular septum for the heart 91 of the human body 90. Details will be described later.

[0022] In the output process, the device position information acquisition unit 14 acquires device position information by using the information acquired by the magnetic sensor array 60. Here, "device position information" means information indicating the position of the tip of the medical device 70. Details will be described later.

[0023] In the output process, the position estimation unit 15 uses the ventricular septum information and the device position information to estimate three-dimensional position information representing the three-dimensional position of the ventricular septum for the heart 91 of the human body 90. In the output process, the output control unit 16 outputs information relating to the three-dimensional position information of the ventricular septum to the monitor 31 of the display device 30. Details will be described later.

[0024] The blood vessel imaging device 20 (FIG. 1) has an FPD and obtains an image by acquiring X-rays that have passed through a human body and converting them into a digital signal. The blood vessel imaging device 20 has a first FPD 21, a first X-ray tube device 22, a first C-arm 23, a first support unit 24, a second FPD 25, a second X-ray tube device 26, a second C-arm 27, a second support unit 28, and a control unit 29.

[0025] The first FPD 21 includes an X-ray flat panel detector, converts X-rays incident from the first X-ray tube device 22 into electrical signals, and performs A / D (analog / digital) conversion to generate an X-ray image. The first X-ray tube device 22 receives a high voltage output from an X-ray high voltage device (not shown) and irradiates an X-ray beam. As shown by a thick dashed line extending in the Y-axis direction in FIG. 1, the X-ray beam irradiated from the first X-ray tube device 22 enters the first FPD 21 through the human body 90. The first C-arm 23 is a C-shaped arm (support) that fixes the first FPD 21 and the first X-ray tube device 22 in opposing positions. The first support 24 rotatably supports the first C-arm 23. That is, the first FPD 21 and the first X-ray tube device 22 can move to any imaging position around the human body 90 lying on the bed 41 while being fixed in opposing positions by the first C-arm 23. Hereinafter, the first FPD 21 and the first X-ray tube device 22 fixed to the first C-arm 23 will also be simply referred to as the "first FPD 21."

[0026] The configuration of the second FPD 25 is the same as that of the first FPD 21. The configuration of the second X-ray tube device 26 is the same as that of the first X-ray tube device 22. As shown by a thick dashed line extending in the X-axis direction in FIG. 1, the X-ray beam emitted from the second X-ray tube device 26 enters the second FPD 25 through the human body 90. The second C-arm 27 is a C-shaped arm (support) that fixes the second FPD 25 and the second X-ray tube device 26 in opposing positions. The second support part 28 supports the second C-arm 27 rotatably. That is, the second FPD 25 and the second X-ray tube device 26 can move to any imaging position around the human body 90 while being fixed in opposing positions by the second C-arm 27. Hereinafter, the second FPD 25 and the second X-ray tube device 26 fixed to the second C-arm 27 will also be simply referred to as the "second FPD 25".

[0027] The second FPD 25 is generally disposed in the normal direction of the first FPD 21. For example, as shown in FIG. 1, when the first FPD 21 is positioned at an imaging position in the front direction of the human body 90 (vertical direction of the human body 90, longitudinal direction of the human body 90), the second FPD 25 is positioned at an imaging position in the horizontal direction of the human body 90 (lateral direction of the human body 90). The blood vessel imaging device 20 may also be simply called an "FPD" or "FPD device". The blood vessel imaging device 20 does not necessarily have to include either the first FPD 21 or the second FPD 25.

[0028] The control unit 29 includes a CPU, a ROM, and a RAM, and the CPU executes a computer program stored in the ROM to control the entire blood vessel imaging device 20. The control unit 29 is electrically connected to each of the first FPD 21, the second FPD 25, the first support unit 24, the second support unit 28, the display device 30, the table 40, and the operation unit 50. The control unit 29 causes the display device 30 to display X-ray images generated by the first FPD 21 and the second FPD 25. In addition, the control unit 29 drives the first support unit 24 to rotate the first C-arm 23 and drives the second support unit 28 to rotate the second C-arm 27 in accordance with an operation from the operation unit 50. Furthermore, the control unit 29 changes the height of the bed 41 by extending and retracting the extension unit 42 and changes the position of the bed 41 by moving the table 40 in the Z-axis direction in accordance with an operation from the operation unit 50.

[0029] The display device 30 (FIG. 1) is connected to the navigation device 10 and the control unit 29 of the blood vessel imaging device 20, and functions as an output interface for the navigation device 10 and the blood vessel imaging device 20. The display device 30 has a monitor 31 and an arm 32. The monitor 31 is a "display unit" configured by known means such as a liquid crystal display, smart glasses, a projector, etc. The arm 32 supports and fixes the monitor 31.

[0030] The table 40 (FIG. 1) is a platform on which the human body 90 lies and is positioned near the first FPD 21 and the second FPD 25. The table 40 has a bed 41, an extension section 42, and legs 43. The bed 41 is equipped with a mattress on which the human body 90 lies. The bed 41 is supported by the table 40 in a state in which it can move in the Z-axis direction. The extension section 42 is configured to be able to change the height of the bed 41 by extending and retracting in the Y-axis direction. The legs 43 support the bed 41 and the extension section 42. As shown by the dashed line in FIG. 1, the human body 90 lies face up on the bed 41 with the head 92 placed on the side closer to the first FPD 21 and the second FPD 25 and the feet 93 placed on the side farther from the first FPD 21 and the second FPD 25. In this way, images of the target blood vessels in the heart 91 can be easily acquired by the first FPD 21 and the second FPD 25.

[0031] The operation unit 50 (FIG. 1) is connected to the navigation device 10 and the control unit 29 of the blood vessel imaging device 20, and functions as an input interface for the navigation device 10 and the blood vessel imaging device 20. The operation unit 50 is an "input unit" configured with well-known means such as a touch panel, operation buttons, operation levers, operation switches, a keyboard, a mouse, a voice input unit, a foot switch, etc. In the illustrated example, the operation unit 50 is fixed to the table 40.

[0032] The magnetic sensor array 60 (FIG. 2) is a device that detects the strength and direction of the magnetic field generated by the human body 90 and the medical device 70. The magnetic sensor array 60 includes a plurality of magnetic sensors 61 arranged in a matrix. The magnetic sensors 61 are detection elements that detect biomagnetic field information, and may be, for example, a GSR (GHz-Spin-Rotation Sensor) sensor, a magnetoresistance effect element (MR), a magneto-impedance element (MI), or a superconducting quantum interference device (SUQUID). The magnetic sensor array 60 is disposed near the center of a bed 41 on which the human body 90 lies. The magnetic sensor array 60 may be configured to be attached to the human body 90 during treatment or diagnosis. For example, the magnetic sensor array 60 may be configured in a belt shape and wrapped around the human body 90, or may be configured in a clothing or hat shape. In these cases, the magnetic sensor 61 may be arranged along the shape of the human body 90. The magnetic sensor array 60 may also be configured in the form of two or more plates, and may be three-dimensionally arranged on one or both of the front and back surfaces of the human body, and on one or both of the side surfaces.

[0033] The medical device 70 (FIG. 2) may be any device such as a guide wire or a catheter. The medical device 70 includes a main body 75, a first magnetized portion 71, a second magnetized portion 72, and a distal tip 74. The main body 75 has an elongated outer shape and is a member formed of any resin material or any metal material. The first magnetized portion 71 and the second magnetized portion 72 are substantially cylindrical or columnar members made of permanent magnets and are brazed, bonded, or welded to the main body 75. The first magnetized portion 71 is disposed between the distal tip 74 and the second magnetized portion 72. The second magnetized portion 72 is disposed at a distance from the first magnetized portion 71 to the proximal end side. At least one of the first magnetized portion 71 and the second magnetized portion 72 may be formed by magnetizing a part of the main body 75, may be composed of an electromagnet, or may be omitted. The tip 74 is a flexible resin member provided at the tip of the main body 75 .

[0034] 3 is a flowchart showing an example of the output process. In step S10, the ventricular septum of the heart 91 is imaged multiple times while the second FPD 25 is moved. Specifically, the second FPD 25 is first moved to a first imaging position to image the ventricular septum of the heart 91. Next, the second FPD 25 is moved to a second imaging position different from the first imaging position to image the ventricular septum of the heart 91. In step S10, the ventricular septum of the heart 91 is imaged while changing the imaging position of the second FPD 25 in this manner, and multiple X-ray images including the ventricular septum are acquired.

[0035] Here, the "imaging position" refers to a position specified by a combination of a left / right position a1 and a top / bottom position a2, which will be described below. (a1) LAO (Left Anterior Oblique view) or RAO (Right Anterior Oblique view) and the angle θ1 from the center O of the human body 90. (a2) CRA (CRAnial) or CAU (CAUdal) and the angle θ2 from the center O of the human body 90. In step S10, imaging may be performed using the first FPD 21 instead of the second FPD 25, or imaging may be performed using both the first FPD 21 and the second FPD 25. In the following, a case where imaging is performed using only the second FPD 25 will be described.

[0036] In step S12, the image acquisition unit 12 acquires the images captured in step S10 and imaging position information of the second FPD 25 when each image was captured. The imaging position information of the second FPD 25 is a position specified by a combination of the left-right position a1 and the up-down position a2 described above.

[0037] FIG. 4 is a diagram for explaining step S14 of the output process. In the center of FIG. 4, the heart 91 and a dashed line representing the imaging plane of the second FPD 25 centered on the ventricular septum 911 are illustrated. In the balloon of FIG. 4, an image 911p of the ventricular septum 911 reflected in an X-ray image obtained in each imaging plane is illustrated. In FIG. 4, for convenience of illustration, the heart 91 and each imaging plane of the second FPD 25 are displayed in two dimensions in a state where one dimension is fixed from the actual three dimensions. In step S14 of FIG. 3, the ventricular septum information acquisition unit 13 determines a specific image. Specifically, the ventricular septum information acquisition unit 13 determines, as a "specific image", one image in which the area of ​​the image 911p of the ventricular septum 911 shown in the image is the largest among the multiple images acquired in step S12. For example, in step S12, when five images are acquired from the imaging planes A1-A1, A2-A2, A3-A3, A4-A4, and A5-A5 shown in FIG. 4, the ventricular septum information acquisition unit 13 determines the image from the imaging plane A3-A3, which has the largest area of ​​the image 911p, to be the specific image.

[0038] FIG. 5 is a diagram for explaining step S16 of the output process. Note that the xyz coordinates shown in FIG. 5 and the following figures are a coordinate system different from the XYZ coordinates shown in FIG. 1 and FIG. 2, and the xyz coordinates do not correspond to the XYZ coordinates. In step S16 of FIG. 3, the ventricular septum information acquisition unit 13 acquires information on the orientation and position of the ventricular septum (ventricular septum information). Specifically, the ventricular septum information acquisition unit 13 determines, from the imaging position information of the second FPD 25 when the specific image determined in step S14 is captured, that the axis passing through the centers of the second X-ray tube device 26 (X-ray tube device) and the second FPD 25 (X-ray detector) at that position as the x-axis. The x-axis corresponds to the "specific axis". The ventricular septum information acquisition unit 13 obtains a plurality of yz planes (yz planes B1 to B5 in the illustrated example) perpendicular to this x-axis (specific axis), and determines the combination of the x-axis and the yz plane as the "ventricular septum information".

[0039] Fig. 6 is a diagram for explaining step S20 of the output process. Fig. 6(A) illustrates a state in which the medical device 70 is inserted into the heart 91 by right heart catheterization. Fig. 6(B) illustrates a state in which the medical device 70 is inserted into the heart 91 by left heart catheterization. In step S20 of Fig. 3, the medical device 70 is inserted into the heart 91 by either the method shown in Fig. 6(A) or Fig. 6(B), and the distal end (distal tip 74) of the medical device 70 is positioned at the apex 912.

[0040] In step S22 of FIG. 3, the device position information acquiring unit 14 acquires device position information. Specifically, the device position information acquiring unit 14 controls the magnetic sensor array 60 to acquire magnetic field information detected by the magnetic sensor array 60. This magnetic field information includes the strength and direction of a magnetic field obtained by combining the biomagnetic field generated by the human body 90 and the device magnetic field generated by the first magnetization section 71 and the second magnetization section 72 of the medical device 70 inserted into the human body 90. The device magnetic field changes as the first magnetization section 71 and the second magnetization section 72 of the medical device 70 move toward the apex 912 inside the heart 91. Therefore, the magnetic field information (biomagnetic field + device magnetic field) detected by the magnetic sensor array 60 also changes as the first magnetization section 71 and the second magnetization section 72 of the medical device 70 move toward the apex 912 inside the heart 91. The device position information acquiring unit 14 acquires the three-dimensional position of the tip of the medical device 70 from the change over time in the magnetic field information, and sets it as "device position information."

[0041] Fig. 7 is a diagram for explaining step S24 of the output process. In step S24 in Fig. 3, the position estimation unit 15 estimates three-dimensional position information of the ventricular septum 911. Specifically, the position estimation unit 15 estimates the three-dimensional position information of the ventricular septum 911 from information on the orientation and position of the ventricular septum (ventricular septum information) acquired in step S16 and the device position information acquired in step S22.

[0042] As shown in FIG. 6(A), the ventricular septum 911 is located near the apex 912. The ventricular septum information acquired in step S16 includes multiple yz planes perpendicular to the x-axis (specific axis). The position estimation unit 15 identifies one yz plane from the multiple yz planes included in the ventricular septum information using device position information representing the position of the medical device 70 inserted up to the apex 912. The position estimation unit 15 may use a yz plane at a position represented by the device position information, for example, or may use a yz plane located a predetermined distance away from the position represented by the device position information toward the left ventricle when the device position information is acquired by the right heart catheterization method of FIG. 6(A). Similarly, for example, when the device position information is acquired by the left heart catheterization method of FIG. 6(B), a yz plane located a predetermined distance away from the position represented by the device position information toward the right ventricle may be used. The one yz plane identified here corresponds to a virtual cross section of the ventricular septum 911.

[0043] The position estimation unit 15 uses the identified yz plane to obtain at least one of the following information b1 and information b2, and sets this as "three-dimensional position information of the ventricular septum." (b1) The identified orientation of the yz plane and the three-dimensional position of the center O of the yz plane. (b2) The x´y´z´ axis, which has its origin at the center O of the identified yz plane and extends in the same direction as the xyz axes.

[0044] Fig. 8 is a diagram showing an example of an image IM displayed in step S30 of the output process. In step S30 in Fig. 3, the output control unit 16 generates an image IM by superimposing first to fourth images OB1 to OB4 shown below on an X-ray image 91p of a heart 91 captured by the second FPD 25, and causes the image IM to be displayed on the monitor 31 of the display device 30. (c1) The first image OB1 is an image showing the three-dimensional position of the ventricular septum, and is an image of any shape superimposed on the position of the ventricular septum 911. In Fig. 8, an elliptical disk-shaped image with a black frame is shown as the first image OB1. The position where the first image OB1 should be superimposed can be determined from the three-dimensional position information of the ventricular septum estimated in step S24. (c2) The second image OB2 is an image of any shape that represents a target position in the ventricular septum 911 where the medicinal liquid should be injected. In Fig. 8, an image of a black circle is shown as an example of the second image OB2. The position where the second image OB2 should be superimposed can be determined based on the three-dimensional position information of the ventricular septum estimated in step S24 and information on the target position identified by a previous examination or the like. (c3) The third image OB3 is an image of an arbitrary shape that represents the position of the tip of the medical device 70. In Fig. 8, an image of a white circle is illustrated as the third image OB3. The position where the third image OB3 should be superimposed can be determined from the device position information identified in step S22. (c4) The fourth image OB4 is an image representing the xyz axes (the xyz axes described in step S24) of the ventricular septum 911, and is used as an auxiliary to the first image OB1.

[0045] 9 is a diagram showing another example of the image IMa displayed in step S30 of the output process. The output control unit 16 may generate the image IMa shown in FIG. 9 instead of the image IM described in FIG. 8, and display the image IMa on the monitor 31 of the display device 30. The image IMa includes an image IM1 showing the whole heart 91, and an image IM2 showing an enlarged view of the heart 91. The image IM1 is similar to the image IM described in FIG. 8. The image IM2 is an image obtained by superimposing the above-mentioned first to third images OB1 to OB3 and a fifth image OB5 described below on an enlarged view 91pa of an X-ray image 91p of the heart 91 captured by the second FPD 25, which is an enlarged view 91pa of the vicinity of the ventricular septum 911. (c5) The fifth image OB5 is an image of an arbitrary shape that represents a route from the current position of the tip of the medical device 70 to a target position to which the medicinal liquid should be injected. In Fig. 9, an image of a white arrow is illustrated as the fifth image OB5.

[0046] The images IM and IMa illustrated in Figs. 8 and 9 are merely examples, and various modes are possible. For example, the output control unit 16 may generate an image in which only the first image OB1 is superimposed on the X-ray image 91p of the heart 91, or may generate an image in which only the second image OB2 is superimposed. In other words, at least one of the first image OB1, the second image OB2, the third image OB3, the fourth image OB4, and the fifth image OB5 can be omitted. Furthermore, the output control unit 16 may generate an image in which at least one of the first to fifth images OB1 to OB5 is superimposed on an enlarged view 91pa that enlarges the vicinity of the ventricular septum 911, instead of the X-ray image 91p of the heart 91, and cause the monitor 31 to display only the enlarged view 91pa. Furthermore, the output control unit 16 may generate an image in which at least one of the first to fifth images OB1 to OB5 described above is superimposed on an image of the heart 91 obtained by a CT (Computed Tomography) device or an MRI (Magnetic Resonance Imaging) device, and display the image on the monitor 31.

[0047] As described above, according to the navigation device 10 of the first embodiment, the ventricular septum information acquisition unit 13 can acquire information on the orientation and position of the ventricular septum 911 (ventricular septum information) without using a conventional electrophysiological mapping method by using a plurality of images acquired while changing the imaging position of the second FPD 25 (FIG. 3: step S16). Furthermore, the position estimation unit 15 can estimate three-dimensional position information of the ventricular septum by using this ventricular septum information and position information of the medical device 70 inserted into the heart 91 without using a conventional electrophysiological mapping method (FIG. 3: step S24). That is, according to the navigation device 10 of the first embodiment, it is possible to estimate three-dimensional position information of the ventricular septum and output information on the three-dimensional position information of the ventricular septum by a simpler method than a system using a conventional complicated electrophysiological mapping method (FIG. 3: step S30, FIGS. 8 and 9).

[0048] Furthermore, according to the navigation device 10 of the first embodiment, the ventricular septum information acquisition unit 13 obtains ventricular septum information from the imaging position of the second FPD 25 when a specific image showing the largest area of ​​the ventricular septum 911p was captured, among a plurality of images obtained while changing the imaging position of the second FPD 25 (FIG. 3: step S16, FIGS. 4 and 5). That is, the ventricular septum information acquisition unit 13 can acquire information (ventricular septum information) related to the orientation and position of the ventricular septum 911 by linking the orientation and position of the ventricular septum 911 to the imaging position of the second FPD 25, in a simpler manner.

[0049] Furthermore, according to the navigation device 10 of the first embodiment, the position estimation unit 15 can easily estimate three-dimensional position information of the ventricular septum by identifying one plane from multiple planes having a specific axis passing through the centers of the second X-ray tube device 26 (X-ray tube device) and the second FPD 25 (X-ray detector) as a perpendicular line when the specific image is captured, using position information of the medical device 70 (FIG. 3: step S24, FIGS. 6 and 7).

[0050] Furthermore, according to the navigation device 10 of the first embodiment, the output controller 16 outputs images IM, IMa in which the first image OB1 indicating the three-dimensional position of the ventricular septum is superimposed on the images 91p, 91pa of the heart 91 captured by the second FPD 25. Therefore, according to the navigation device 10 of the first embodiment, it is possible to provide guidance on the three-dimensional position of the ventricular septum using the images 91p, 91pa of the actual patient's heart 91 (FIGS. 8 and 9).

[0051] Furthermore, according to the navigation device 10 of the first embodiment, the output controller 16 outputs images IM, IMa in which a second image OB2 representing a target position to which the medicinal liquid should be injected within the ventricular septum 911 is superimposed on the images 91p, 91pa of the heart 91 captured by the second FPD 25. Therefore, according to the navigation device 10 of the first embodiment, the target position to which the medicinal liquid should be injected can be guided using the images 91p, 91pa of the actual patient's heart 91 (FIGS. 8 and 9).

[0052] Furthermore, according to the navigation device 10 of the first embodiment, the output control unit 16 further outputs images IM, IMa on which a third image OB3 showing the position of the tip of the medical device 70 inside the heart 91 is superimposed. Therefore, according to the navigation device 10 of the first embodiment, it is possible to use images 91p, 91pa of the actual patient's heart 91 to provide guidance on the position to which the tip of the medical device 70 should be directed (i.e., at least one of the three-dimensional position of the ventricular septum and the target position to which the medicinal liquid should be injected) and the current position of the tip of the medical device 70 (FIGS. 8 and 9).

[0053] When attempting to provide three-dimensional position information of the ventricular septum using images obtained by a CT device, it is difficult to align the CT image with the position of the ventricular septum 911, making it difficult to display in real time. Furthermore, in intracardiac catheter echo (ICE) using ultrasound, the influence of the pulsation of the heart 91 is large, making control complex and making it difficult to display in real time. In this regard, the navigation device 10 using the blood vessel imaging device 20 can estimate three-dimensional position information of the ventricular septum in a simpler manner than when a CT device or ICE is used, and can output information relating to the three-dimensional position information of the ventricular septum.

[0054] <Second embodiment> Fig. 10 is a flowchart showing an example of the output process of the second embodiment. In the second embodiment, the medical system 1 includes a navigation device 10A instead of the navigation device 10. The navigation device 10A executes the output process shown in Fig. 10 instead of the output process described in Fig. 3. In the output process of the second embodiment, step S30A is executed instead of step S30 described in Fig. 3.

[0055] 11 is a diagram illustrating step S30A of the output process. In step S30A, the output control unit 16 outputs the three-dimensional position information of the ventricular septum estimated in step S24. This output can be in any form such as d1 to d4 shown below. (d1) The output control unit 16 transmits the three-dimensional position information of the ventricular septum to the control unit 29 of the blood vessel imaging device 20. The control unit 29 may automatically determine the imaging position of the first FPD 21 and the imaging position of the second FPD 25 using the received three-dimensional position information of the ventricular septum. (d2) The output control unit 16 notifies the operator of the three-dimensional position information of the ventricular septum by audio output. (d3) The output control unit 16 transmits the three-dimensional position information of the ventricular septum to another device (e.g., a server device, a storage device, etc.) connected to the medical system 1 via a network. The other device may display the received three-dimensional position information of the ventricular septum on a monitor or the like, or may store it in a storage unit. (d4) As shown in FIG. 11, the output control unit 16 may output, in addition to the three-dimensional position information of the ventricular septum, at least one of the target position (there may be multiple positions) into which the medicinal liquid should be injected and device position information of the medical device 70 in accordance with the above-mentioned aspects d1 to d3.

[0056] <Modifications of this embodiment> In the above embodiment, a part of the configuration realized by hardware may be replaced by software, and conversely, a part of the configuration realized by software may be replaced by hardware. Furthermore, the present invention is not limited to the above embodiment, and can be embodied in various aspects without departing from the gist of the present invention, and for example, the following modifications are also possible.

[0057] [Variation 1] In the first and second embodiments, the configuration of the medical system 1 has been described. However, the configuration of the medical system 1 can be modified in various ways. For example, in the medical system 1, the navigation device 10 may be connected to the blood vessel imaging device 20 and the like via the Internet. For example, the display device 30 may be a monitor or a touch panel built into the navigation device 10. For example, the blood vessel imaging device 20 may be configured to have a single FPD (in other words, a configuration without the second FPD 25). For example, the medical system 1 may have other medical devices (e.g., a CT device, an MRI device) not shown. In this case, the above-mentioned images IM and IMa may include images acquired by the other medical devices.

[0058] [Variation 2] In the above first and second embodiments, the configuration of the navigation device 10, 10A has been described. However, various modifications are possible to the configuration of the navigation device 10. For example, various modifications are possible to the procedure of the guidance process described in Fig. 3 and Fig. 10, and the execution order of each step may be changed, at least some steps may be omitted, and other steps not described may be executed.

[0059] For example, in step S12, the image acquiring unit 12 may acquire the multiple images and the FPD imaging position information not from the blood vessel imaging device 20 but via a network or a storage medium.

[0060] For example, some heart failure patients have an ICD (Implantable Cardioverter Defibrillator) or a magnetic marker embedded in the heart 91. Some dilated cardiomyopathy patients have a cardiac shape correction net that covers the heart 91. For such patients, ventricular septum information may be acquired by any of the following methods e1, e2, and e3 instead of steps S10 to S16. (e1) The ventricular septum information acquisition unit 13 controls the magnetic sensor array 60 while a current is flowing through the ICD probe or the cardiac shape correction net to acquire magnetic field information detected by the magnetic sensor array 60. The acquired magnetic field information includes the strength and direction of the combined magnetic field of the biomagnetic field generated by the human body 90 and the magnetic field generated by the ICD probe or the cardiac shape correction net (hereinafter also referred to as the "cardiac device magnetic field"). The ventricular septum information acquisition unit 13 can acquire information (ventricular septum information) regarding the orientation and position of the ventricular septum 911 by comparing the magnetic field information (only the biomagnetic field) acquired before the current is flowed with the magnetic field information (the biomagnetic field + the cardiac device magnetic field) acquired while the current is flowing. (e2) The ventricular septum information acquiring unit 13 applies a current to the ICD probe (only in the case of an ICD with a biventricular pacing function) or the cardiac shape correction net in order from the probe located on the left ventricle side to the probe located on the right ventricle. Then, in the same procedure as described in step e1, the positions of the left ventricle, the ventricular septum 911, and the right ventricle may be estimated, and information on the orientation and position of the ventricular septum 911 (ventricular septum information) may be acquired. (e3) The ventricular septum information acquisition unit 13 controls the magnetic sensor array 60 to detect the positions of the magnetic markers embedded in the heart 91. The ventricular septum information acquisition unit 13 can acquire information (ventricular septum information) regarding the orientation and position of the ventricular septum 911 based on the positional relationship between the positions at which the magnetic markers are embedded and the ventricular septum 911.

[0061] [Variation 3] The configurations of the navigation devices 10 and 10A in the first and second embodiments and the configurations of the first and second modifications may be appropriately combined. For example, the configurations and methods described in the first and second modifications may be used in the output process described in the second embodiment.

[0062] Although the present aspect has been described above based on the embodiment and modified examples, the above-mentioned embodiment of the aspect is intended to facilitate understanding of the present aspect and does not limit the present aspect. The present aspect may be modified or improved without departing from the spirit and scope of the claims, and equivalents are included in the present aspect. Furthermore, if a technical feature is not described as essential in this specification, it may be deleted as appropriate. [Explanation of symbols]

[0063] 1. Healthcare system 10, 10A…Navigation device 11...Main control unit 12...Image acquisition section 13...Ventricular septal information acquisition unit 14...Device location information acquisition unit 15...Position estimation section 16...Output control section 20...Blood vessel imaging device 21…1st FPD 22...1st X-ray tube device 23…1st C-arm 24...First support part 25…2nd FPD 26…Second X-ray tube device 27…Second C-arm 28…Second support part 29...Control section 30…Display device 31…Monitor 32…Arm 40…Table 41…Bed 42...Extendable part 43...legs 50...Operation unit 60...Magnetic sensor array 61...Magnetic sensor 70…Medical Devices 71...First magnetization part 72…Second magnetization part 74…Tip 75…Main body 90...Human body 91...Heart 92…head 93…foot 911…Ventricular septum 912…apex of the heart

Claims

1. 1. A navigation device, comprising: an image acquisition unit that acquires images of the ventricular septum of the heart while changing an imaging position of a flat panel detector (FPD) to acquire a plurality of images including the ventricular septum; a ventricular septum information acquiring unit that acquires ventricular septum information, which is information regarding the orientation and position of the ventricular septum, using the plurality of images; a device position information acquiring unit for acquiring position information of a medical device inserted into the heart; a position estimation unit that estimates three-dimensional position information of the ventricular septum using the ventricular septum information and position information of the medical device; an output control unit that outputs information regarding the three-dimensional position information of the ventricular septum; A navigation device comprising:

2. 2. A navigation device according to claim 1, The ventricular septum information acquisition unit Among the plurality of images, an image in which the area of ​​the ventricular septum is the largest is designated as a specific image; A navigation device that obtains the ventricular septum information from an imaging position of the FPD when the specific image is captured.

3. 3. A navigation device according to claim 2, The position estimation unit estimates three-dimensional position information of the ventricular septum by using position information of the medical device to identify one plane from multiple planes having a perpendicular line aligned with a specific axis passing through the centers of an X-ray tube assembly fixed at a position opposite the FPD and the X-ray detector of the FPD when the specific image was captured.

4. A navigation device according to any one of claims 1 to 3, The output control unit outputs an image in which a first image indicating a three-dimensional position of the ventricular septum is superimposed on an image of the heart captured by the FPD.

5. A navigation device according to any one of claims 1 to 4, The output control unit outputs an image in which a second image representing a target position in the ventricular septum into which a medicinal liquid should be injected is superimposed on the image of the heart captured by the FPD.

6. A navigation device according to claim 4 or claim 5, The output control unit further outputs the image on which a third image showing the position of the tip of the medical device inside the heart is superimposed.

7. A navigation method, comprising: imaging the ventricular septum of the heart at a plurality of different imaging positions of the FPD to obtain a plurality of images including the ventricular septum; acquiring ventricular septum information, which is information regarding the orientation and position of the ventricular septum, using the plurality of images; acquiring position information of a medical device inserted into the heart; estimating three-dimensional position information of the ventricular septum using the ventricular septum information and position information of the medical device; outputting information regarding the three-dimensional position information of the ventricular septum; ,The navigation method.

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