WO2019176533A1

WO2019176533A1 - Medical device and identification method

Info

Publication number: WO2019176533A1
Application number: PCT/JP2019/007394
Authority: WO
Inventors: 秀彬柴田; 康之本間
Original assignee: テルモ株式会社
Priority date: 2018-03-15
Filing date: 2019-02-26
Publication date: 2019-09-19
Also published as: JPWO2019176533A1

Abstract

A medical device according to the present invention is provided with an elongated body provided with a marker, wherein the marker includes the center axis line of the elongated body and has a shape that is asymmetrical with respect to an arbitrary virtual surface parallel to the center axis line.

Description

Medical device and identification method

This disclosure relates to medical devices and identification methods.

In the treatment of heart failure and the like, tissue around the atrioventricle (using a medical device such as a catheter in which an injection material such as a cell or a biomaterial or the like is inserted into the atrioventricle of the heart via a femoral artery or the like) For example, treatments that are injected into the myocardium around the left ventricle) and are expected to have therapeutic effects such as angiogenesis and cell differentiation are being studied. As a treatment for arrhythmia and the like, there is an ablation treatment in which a site causing arrhythmia is cauterized by a medical device inserted into the chamber of the heart.

In the treatment performed by inserting the medical device into the heart as described above, the position of the medical device in the heart is moved in order to move the medical device to an appropriate position with respect to the treatment site in the heart. It is necessary to grasp.

In Patent Document 1, there is a technology that makes it easy to identify the position of a catheter by forming an image obtained by fusing or superimposing previously acquired three-dimensional data (CT scan, MRI image, etc.) on an X-ray fluoroscopic image. It is disclosed.

Special table 2009-519083

In a treatment performed using a medical device such as a catheter as described above, it is common for an operator to perform a procedure while viewing a fluoroscopic image such as an X-ray fluoroscopic image obtained by fluoroscopying the heart from a predetermined direction. is there. In the fluoroscopic image, the two-dimensional motion of the atrioventricle and the medical device in the projection plane of the fluoroscopic image can be evaluated by contrasting the atrioventricular (for example, the left ventricle) and the medical device. However, it is not possible to evaluate the movement of the medical device in the depth direction and the front direction (hereinafter, collectively referred to as “backward direction”) orthogonal to the projection plane of the X-ray fluoroscopic image.

On the other hand, there is a method of using three-dimensional data as in Patent Document 1, but a CT (Computed Tomography) apparatus, an MRI (Magnetic Resonance Imaging) apparatus, a SPECT (Single Photon Emission Computed Tomography) apparatus, and a PET (Positron). An imaging apparatus such as an Emission (computed (Tomography) apparatus) is not usually installed in a cardiac catheter room that performs the above-described treatment. In addition, transesophageal echo requires general anesthesia, so it is not invasive and has a heavy burden on intraoperative management. Furthermore, transthoracic echoes may be difficult to obtain information depending on the body type.

Therefore, an object of the present disclosure is to provide a medical device and an identification method capable of identifying the movement in the front direction perpendicular to the projection plane in a fluoroscopic image.

The medical device according to the first aspect of the present disclosure includes a long body including a marker, and the marker includes a central axis of the long body, with respect to an arbitrary virtual plane parallel to the central axis. Have an asymmetrical shape.

As one embodiment, the marker includes a first marker portion formed over at least a partial region in the circumferential direction of the elongated body, and the first marker in the circumferential direction among the virtual surfaces. A second marker portion having an asymmetric shape with respect to an intermediate virtual plane passing through an intermediate position of the portion.

As one embodiment, the first marker portion is formed over a range of 45 degrees or more in the circumferential direction with a central angle centered on the central axis.

As one embodiment, the first marker portion extends linearly in the circumferential direction or in a direction inclined with respect to the circumferential direction.

As one embodiment, the first marker portion extends linearly in the circumferential direction.

As one embodiment, the first marker portion is provided at the tip of the elongated body.

As one embodiment, the elongate body includes a flexible main body portion, and a movable portion that is continuous with a distal end side of the main body portion and can be bent and deformed with respect to the main body portion. Is a first bending direction that is one side of an imaginary straight line that passes through the central axis and a second bending direction that is the other side of the imaginary straight line in a cross-sectional view orthogonal to the central axis of the main body. The first marker part can be bent and deformed, and the first marker part intersects the virtual straight line on the first bending direction side among the peripheral walls of the movable part in the sectional view, and the second bending direction. It forms in the area | region of the said circumferential direction including any one surrounding wall part of the 2nd surrounding wall part which cross | intersects the said virtual straight line on the side.

As one embodiment, the elongated body includes a detection unit capable of detecting biological information, and at least a part of the marker is configured by the detection unit.

An identification method as a second aspect of the present disclosure is an identification method for identifying a bending direction of the long body using a long body including a marker, and the marker has a central axis of the long body. Projection of the fluoroscopic image based on the appearance of the marker in a fluoroscopic image having an asymmetric shape with respect to an arbitrary virtual plane parallel to the central axis and including the marker A bending direction of the elongated body in the front side direction orthogonal to the surface is identified.

According to the present disclosure, it is possible to provide a medical device and an identification method that can identify the movement in the front direction perpendicular to the projection plane in a fluoroscopic image.

It is a schematic diagram showing an outline of the treatment performed on the treatment site of the myocardium from the left ventricle of the heart as an example of the treatment performed using the medical device as one embodiment. It is a figure which shows an example of the X-ray fluoroscopic image of the heart displayed by an image display apparatus during the treatment shown in FIG. It is a figure which shows the front-end | tip part vicinity of the catheter main body of the catheter shown in FIG. It is a figure which shows how a marker looks when the front-end | tip part of a catheter main body is seen toward the direction of the white arrow P1 shown in FIG. It is a figure which shows how a marker looks when the front-end | tip part of a catheter main body is seen toward the direction of the white arrow P2 shown in FIG. It is a figure which shows how a marker looks when the front-end | tip part of a catheter main body is seen toward the direction of the white arrow P3 shown in FIG. It is a figure which shows how a marker looks when the front-end | tip part of a catheter main body is seen toward the direction of the white arrow P4 shown in FIG. It is a figure which shows the marker as a modification of the marker shown in FIG. Fig.9 (a) is a side view which shows the catheter main body with which the bending direction of the front-end | tip part is restrict | limited, FIG.9 (b) is II sectional drawing of Fig.9 (a). It is a flowchart which shows an example of the procedure performed using the catheter shown in FIG.

Hereinafter, embodiments of the medical device and the identification method according to the present disclosure will be described with reference to FIGS. In each figure, the same code | symbol is attached | subjected to the common member and site | part.

FIG. 1 shows an outline of an operation performed on a treatment site such as an infarct portion Z of the myocardium from within the left ventricle LV of the heart as an example of the operation performed using the catheter 1 as the medical device of the present embodiment. FIG. FIG. 2 is a diagram illustrating an example of an X-ray fluoroscopic image of the heart displayed on the display unit 101 of the image display device 100 during the treatment shown in FIG.

As shown in FIG. 1, the catheter 1 of this embodiment is delivered into the heart through blood vessels and used for predetermined diagnosis and treatment in the heart. Specifically, the catheter 1 of this embodiment is inserted into the left ventricle LV from the femoral artery FA through the aorta AO and the aortic valve AV. As shown in FIG. 1, an image display device 100 and an X-ray imaging device 200 are installed outside the body. During the treatment, the X-ray imaging apparatus 200 can, for example, see through the X-ray from the front side of the living body toward the back side and take an X-ray fluoroscopic image of the heart. In FIG. 1, the range imaged by the X imaging device 200 is indicated by a two-dot chain line. As illustrated in FIG. 2, the display unit 101 of the image display apparatus 100 can display an X-ray fluoroscopic image captured by the X-ray imaging apparatus 200.

A catheter 1 as a medical device includes a tubular catheter body 2 as a long body inserted into a living body. The catheter body 2 includes a marker 3. The marker 3 includes, for example, a radiopaque material such as gold, platinum, tungsten, or an alloy thereof, or a silver-palladium alloy or a platinum-iridium alloy. Therefore, the position of the catheter 1 located in the heart during the procedure can be monitored in an X-ray fluoroscopic image displayed on the image display device 100 due to the presence of the marker 3. In the present embodiment, the tubular catheter body 2 will be described below as an example of the long body, but the long body is not limited to the tubular catheter body. The elongated body may be, for example, a solid linear member.

FIG. 3 is a view showing the vicinity of the distal end portion 2a of the catheter body 2 as a long body. As shown in FIG. 3, the marker 3 of the catheter body 2 includes a central axis O of the catheter body 2 as an elongated body, and has an asymmetric shape with respect to an arbitrary virtual plane parallel to the central axis O. Specifically, in FIG. 3, two virtual planes Y1 and Y2 are shown as examples of virtual planes including the central axis O of the catheter body 2 and parallel to the central axis O. As shown in FIG. 3, the marker 3 has an asymmetric shape with respect to each of the virtual surfaces Y1 and Y2. In other words, the marker 3 includes a central axis O of the catheter body 2 and has a shape that is not plane-symmetric with respect to all virtual planes parallel to the central axis O. Hereinafter, for convenience of explanation, an arbitrary virtual plane including the central axis O of the catheter body 2 and parallel to the central axis O is simply referred to as “virtual plane Y”.

By configuring the marker 3 with such a configuration, depending on how the marker 3 is seen in the X-ray fluoroscopic image, the back front direction orthogonal to the projection plane in the X-ray fluoroscopic image (hereinafter simply referred to as “the back front direction A” (FIG. 2))), and the movement of the catheter body 2 can be identified.

As shown in FIG. 3, the marker 3 of this embodiment includes a first marker portion 11 and a second marker portion 12. The first marker portion 11 has an asymmetric shape with respect to the first intermediate virtual surface passing through the intermediate position of the second marker portion 12 in the circumferential direction B in the virtual surface Y. In addition, the second marker portion 12 has an asymmetric shape with respect to the second intermediate virtual surface passing through the intermediate position of the first marker portion 11 in the circumferential direction B in the virtual surface Y. The “first intermediate virtual surface” in the present embodiment is the virtual surface Y1 shown in FIG. Therefore, hereinafter, the virtual surface Y1 is referred to as “first intermediate virtual surface Y1”. Further, the “second intermediate virtual surface” in the present embodiment is the virtual surface Y2 shown in FIG. Therefore, hereinafter, the virtual surface Y2 is referred to as “second intermediate virtual surface Y2”.

The first marker portion 11 of the present embodiment is formed over at least a partial region in the circumferential direction B of the catheter body 2 as an elongated body. More specifically, the first marker portion 11 of the present embodiment extends linearly in the circumferential direction B. Moreover, the 1st marker part 11 of this embodiment is provided in the front-end | tip part 2a of the catheter main body 2 as a elongate body. More specifically, the first marker portion 11 of the present embodiment is formed linearly in the circumferential direction B on the distal end surface of the catheter body 2.

The second marker portion 12 of the present embodiment extends linearly along the central axis direction C parallel to the central axis O. As shown in FIG. 2, the second marker portion 12 of the present embodiment extends not only to the distal end portion 2a of the catheter body 2 but also to the proximal end side from the distal end portion 2a. Therefore, the in-vivo catheter main body 2 can monitor not only the position of the distal end portion 2a but also the position of the proximal end in the X-ray fluoroscopic image.

Hereinafter, an identification method for identifying the movement of the catheter body 2 in the frontward direction A based on the appearance of the marker 3 shown in FIG. 3 will be described. FIG. 4 shows a case where the distal end portion 2a of the catheter body 2 as a long body is viewed in the direction of the hollow arrow P1 shown in FIG. 3 (hereinafter simply referred to as “when viewed from the viewpoint of the arrow P1”). It is a figure which shows the appearance of the marker 3 about. FIG. 5 shows a case where the distal end portion 2a of the catheter body 2 as an elongated body is viewed in the direction of the white arrow P2 shown in FIG. 3 (hereinafter simply referred to as “when viewed from the viewpoint of the arrow P2”). It is a figure which shows the appearance of the marker 3 about. FIG. 6 shows a case where the distal end portion 2a of the catheter body 2 as a long body is viewed in the direction of the white arrow P3 shown in FIG. 3 (hereinafter simply referred to as “when viewed from the viewpoint of the arrow P3”). It is a figure which shows the appearance of the marker 3 about. FIG. 7 shows a case where the distal end portion 2a of the catheter body 2 as a long body is viewed in the direction of the white arrow P4 shown in FIG. 3 (hereinafter simply referred to as “when viewed from the viewpoint of the arrow P4”). It is a figure which shows the appearance of the marker 3 about.

FIG. 4A shows a state where the distal end portion 2a of the catheter body 2 is not deformed in the frontward direction A when viewed from the viewpoint of the arrow P1, that is, the distal end portion 2a of the catheter body 2 is in the direction of the arrow P1. It shows a state extending in a direction orthogonal to. The distal end portion 2a of the catheter main body 2 in the state shown in FIG. 4A appears as shown in FIG. 4B when viewed from the viewpoint of the arrow P1. As shown in FIG. 4B, when viewed from the viewpoint of the arrow P1, the first marker portion 11 of the marker 3 extends linearly along the radial direction D perpendicular to the central axis direction C. Looks like a shape. As shown in FIG. 4B, when viewed from the viewpoint of the arrow P1, the second marker portion 12 of the marker 3 looks like a shape extending linearly along the central axis direction C.

FIG. 4C shows a front direction A2 of the front side direction A2 (FIG. 4) of the distal end portion 2a of the catheter body 2 when compared with the state shown in FIG. In (c), it is a downward direction and shows a state of being deformed in a direction approaching the viewpoint when viewed from the viewpoint of the arrow P1. The distal end portion 2a of the catheter body 2 in the state shown in FIG. 4 (c) appears as shown in FIG. 4 (d) when viewed from the viewpoint of the arrow P1. As shown in FIG. 4D, when viewed from the viewpoint of the arrow P1, the first marker portion 11 of the marker 3 looks like an arc shape that is convex toward the base end side in the central axis direction C. As shown in FIG. 4D, when viewed from the viewpoint of the arrow P1, the second marker portion 12 of the marker 3 looks like a shape extending linearly along the central axis direction C. The position of the second marker portion 12 in the radial direction D orthogonal to the central axis direction C in FIG. 4D is the same as the position of the second marker portion 12 in the radial direction D of FIG. Thus, the shape of the 1st marker part 11 in FIG.4 (d) differs from the shape of the 1st marker part 11 in FIG.4 (b). On the other hand, the position and shape of the second marker portion 12 in FIG. 4 (d) look the same as the position and shape of the second marker portion 12 in FIG. 4 (b).

FIG. 4 (e) shows a depth direction A1 (FIG. 4) in which the distal end portion 2a of the catheter body 2 is in the depth direction A1 as compared to the state shown in FIG. 4 (a) when viewed from the viewpoint of the arrow P1. In (e), it is an upward direction, and shows a state of being deformed in a direction away from the viewpoint when viewed from the viewpoint of the arrow P1. The distal end portion 2a of the catheter body 2 in the state shown in FIG. 4 (e) looks like the state in FIG. 4 (f) when viewed from the viewpoint of the arrow P1. As shown in FIG. 4F, when viewed from the viewpoint of the arrow P1, the first marker portion 11 of the marker 3 looks like an arc shape that is convex toward the tip side in the central axis direction C. As shown in FIG. 4 (f), when viewed from the viewpoint of the arrow P 1, the second marker portion 12 of the marker 3 looks like a shape extending linearly along the central axis direction C. 4 (f), the position of the second marker portion 12 in the radial direction D perpendicular to the central axis direction C is the same as the position of the second marker portion 12 in the radial direction D of FIGS. 4 (b) and 4 (d). The same. That is, the shape of the first marker portion 11 in FIG. 4 (f) is different from the shape of the first marker portion 11 in FIGS. 4 (b) and 4 (d). On the other hand, the position and shape of the second marker part 12 in FIG. 4 (f) are the same as the position and shape of the second marker part 12 in FIGS. 4 (b) and 4 (d).

Therefore, in the X-ray transmission image obtained by seeing through the X-ray from the direction of the arrow P1 shown in FIG. 3, the change in the shape of the first marker portion 11 is observed, so that The movement in the front direction A can be identified. More specifically, in the present embodiment, when the shape of the first marker portion 11 appears to be a circular arc that is convex toward the base end side in the central axis direction C, the first marker portion 11 moves in the front direction A2 of the front side direction A. Can be identified (see FIG. 4 (c) and FIG. 4 (d)). Moreover, in this embodiment, when the shape of the 1st marker part 11 looks like the circular arc shape which becomes convex at the front end side of the center axis direction C, it has moved to the depth direction A1 of the back front direction A, or Can be identified (see FIGS. 4E and 4F). Although details will be described later, the presence of the second marker portion 12 makes it possible to distinguish from the determination of the rear front direction A when viewed from the viewpoint of the arrow P3 (see FIG. 6).

FIG. 5A shows a state in which the distal end portion 2a of the catheter body 2 is not deformed in the frontward direction A when viewed from the viewpoint of the arrow P2, that is, the distal end portion 2a of the catheter body 2 is in the direction of the arrow P2. It shows a state extending in a direction orthogonal to. The distal end portion 2a of the catheter body 2 in the state shown in FIG. 5 (a) appears as shown in FIG. 5 (b) when viewed from the viewpoint of the arrow P2. As shown in FIG. 5B, when viewed from the viewpoint of the arrow P2, the first marker portion 11 of the marker 3 extends linearly along the radial direction D perpendicular to the central axis direction C. Looks like a shape. As shown in FIG. 5B, when viewed from the viewpoint of the arrow P2, the second marker portion 12 of the marker 3 looks like a shape extending linearly along the central axis direction C.

FIG. 5 (c) shows that the distal end portion 2a of the catheter body 2 is closer to the front direction A2 (FIG. 5) than the rear direction A compared to the state shown in FIG. 5 (a) when viewed from the viewpoint of the arrow P2. In (c), it is a downward direction, and shows a state of being deformed in a direction approaching the viewpoint when viewed from the viewpoint of the arrow P2. The distal end portion 2a of the catheter body 2 in the state shown in FIG. 5 (c) appears as shown in FIG. 5 (d) when viewed from the viewpoint of the arrow P2. As shown in FIG. 5D, when viewed from the viewpoint of the arrow P2, the first marker portion 11 of the marker 3 has a convex shape on one side in the radial direction D (upper side in FIG. 5D). Looks like a U shape. As shown in FIG. 5D, when viewed from the viewpoint of the arrow P2, the second marker portion 12 of the marker 3 looks like a shape extending linearly along the central axis direction C. In FIG. 5D, the position of the second marker portion 12 in the radial direction D is the same as the position of the second marker portion 12 in the radial direction D of FIG. That is, the shape of the first marker portion 11 in FIG. 5D is different from the shape of the first marker portion 11 in FIG. On the other hand, the position and shape of the second marker portion 12 in FIG. 5 (d) look the same as the position and shape of the second marker portion 12 in FIG. 5 (b).

FIG. 5 (e) shows that the distal end portion 2a of the catheter body 2 has a depth direction A1 in the depth direction A1 (see FIG. 5) compared to the state shown in FIG. 5 (a) when viewed from the viewpoint of the arrow P2. (E) shows a state of being deformed in the upward direction, ie, a direction away from the viewpoint when viewed from the viewpoint of the arrow P2. The distal end portion 2a of the catheter body 2 in the state shown in FIG. 5 (e) looks like the state of FIG. 5 (f) when viewed from the viewpoint of the arrow P2. As shown in FIG. 5 (f), when viewed from the viewpoint of the arrow P2, the first marker portion 11 of the marker 3 has a convex shape on one side in the central axis direction C (upper side in FIG. 5 (d)). It looks like a U shape. That is, the shape of the first marker portion 11 shown in FIG. 5 (f) is the same as the shape of the first marker portion 11 shown in FIG. 5 (d). As shown in FIG. 5F, when viewed from the viewpoint of the arrow P2, the second marker portion 12 of the marker 3 looks like a shape extending linearly along the central axis direction C. In FIG. 5 (f), the position of the second marker portion 12 in the radial direction D is the same as the position of the second marker portion 12 in the radial direction D of FIGS. 5 (b) and 5 (d). However, the positional relationship in the central axis direction C of the first marker portion 11 and the second marker portion 12 in FIG. 5F is the direction of the central axis direction of the first marker portion 11 and the second marker portion 12 in FIG. It is different from the positional relationship in C.

Therefore, in the X-ray transmission image obtained by seeing through the X-ray from the direction of the arrow P2 shown in FIG. 3, only by looking at the change in the shape of the first marker portion 11, the distal end portion 2a of the catheter body 2 It is not possible to identify the movement in the front direction A. However, by confirming the positional relationship of the first marker portion 11 and the second marker portion 12 in the central axis direction C together, the movement of the distal end portion 2a of the catheter body 2 in the frontward direction A can be identified. Specifically, in the marker 3 of the present embodiment, the distal end of the catheter body 2 is confirmed by confirming which end portion of the first marker portion 11 in which the second marker portion 12 looks U-shaped is continuous. The movement of the part 2a in the frontward direction A can be identified. More specifically, the end portion on the distal end side in the central axis direction C of the second marker portion 12 is continuous with the end portion located on the distal end side in the central axial direction C of the first marker portion 11 that looks U-shaped. If it is present (see FIGS. 5C and 5D), it can be identified that the distal end portion 2a of the catheter body 2 is moving in the front direction A2 or has been moved. On the other hand, the end portion on the distal end side in the central axis direction C of the second marker portion 12 is continuous with the end portion located on the proximal end side in the central axial direction C of the first marker portion 11 that looks U-shaped. If it is present (see FIGS. 5 (e) and 5 (f)), it can be identified that the distal end portion 2a of the catheter body 2 has moved in the depth direction A1 or has moved. Although the details will be described later, the presence of the first marker portion 11 can be distinguished from the determination of the front side direction A when viewed from the viewpoint of the arrow P4 (see FIG. 7).

FIG. 6A shows a state in which the distal end portion 2a of the catheter body 2 is not deformed in the frontward direction A when viewed from the viewpoint of the arrow P3, that is, the distal end portion 2a of the catheter body 2 is in the direction of the arrow P3. It shows a state extending in a direction orthogonal to. The second marker portion 12 is located on the back side of the catheter body 2 in the state shown in FIG. 6A and in the state shown in FIG. 6C and FIG. The position is indicated by a broken line. The distal end portion 2a of the catheter body 2 in the state shown in FIG. 6 (a) looks like the state in FIG. 6 (b) when viewed from the viewpoint of the arrow P3. As shown in FIG. 6B, when viewed from the viewpoint of the arrow P3, the first marker portion 11 of the marker 3 extends linearly along the radial direction D perpendicular to the central axis direction C. Looks like a shape. Further, as shown in FIG. 6B, when viewed from the viewpoint of the arrow P3, the second marker portion 12 of the marker 3 appears to have a shape extending linearly along the central axis direction C.

FIG. 6C shows the front direction A2 of the front side direction A2 (FIG. 6) when the distal end portion 2a of the catheter body 2 is compared with the state shown in FIG. In (c), it is a downward direction and shows a state of being deformed in a direction approaching the viewpoint when viewed from the viewpoint of the arrow P3. The distal end portion 2a of the catheter body 2 in the state shown in FIG. 6 (c) appears as shown in FIG. 6 (d) when viewed from the viewpoint of the arrow P3. As shown in FIG. 6D, when viewed from the viewpoint of the arrow P3, the first marker portion 11 of the marker 3 appears to have a circular arc shape that is convex toward the tip side in the central axis direction C. As shown in FIG. 6D, when viewed from the viewpoint of the arrow P3, the second marker portion 12 of the marker 3 looks like a shape extending linearly along the central axis direction C. The position of the second marker portion 12 in the radial direction D perpendicular to the central axis direction C in FIG. 6D is the same as the position of the second marker portion 12 in the radial direction D in FIG. Thus, the shape of the 1st marker part 11 in FIG.6 (d) differs from the shape of the 1st marker part 11 in FIG.6 (b). On the other hand, the position and shape of the second marker portion 12 in FIG. 6D look the same as the position and shape of the second marker portion 12 in FIG.

6 (e) shows a depth direction A1 (FIG. 6) in which the distal end portion 2a of the catheter body 2 is in the depth direction A1 as compared to the state shown in FIG. 6 (a) when viewed from the viewpoint of the arrow P3. (E) shows a state in which it is deformed in the upward direction and in a direction away from the viewpoint when viewed from the viewpoint of arrow P3. The distal end portion 2a of the catheter body 2 in the state shown in FIG. 6 (e) looks like the state in FIG. 6 (f) when viewed from the viewpoint of the arrow P3. As shown in FIG. 6 (f), when viewed from the viewpoint of the arrow P 3, the first marker portion 11 of the marker 3 appears to have a circular arc shape that is convex toward the base end side in the central axis direction C. As shown in FIG. 6 (f), when viewed from the viewpoint of the arrow P 3, the second marker portion 12 of the marker 3 looks like a shape extending linearly along the central axis direction C. 6 (f), the position of the second marker portion 12 in the radial direction D perpendicular to the central axis direction C is the same as the position of the second marker portion 12 in the radial direction D of FIGS. 6 (b) and 6 (d). The same. That is, the shape of the first marker portion 11 in FIG. 6 (f) is different from the shape of the first marker portion 11 in FIGS. 6 (b) and 6 (d). On the other hand, the position and shape of the second marker part 12 in FIG. 6 (f) are the same as the position and shape of the second marker part 12 in FIGS. 6 (b) and 6 (d).

Therefore, in the X-ray transmission image obtained by seeing through the X-ray from the direction of the arrow P3 shown in FIG. 3, by looking at the change in the shape of the first marker portion 11, the back of the distal end portion 2a of the catheter body 2 is The movement in the front direction A can be identified. More specifically, in the present embodiment, when the shape of the first marker portion 11 appears to be a circular arc that is convex toward the distal end side in the central axis direction C, the first marker portion 11 moves in the front direction A2 of the back front direction A. Can be identified (see FIG. 6C and FIG. 6D). Moreover, in this embodiment, when the shape of the 1st marker part 11 looks like the circular arc which becomes convex at the base end side of the center axis direction C, it has moved to the depth direction A1 of the back direction A, Or it can identify that it moved (refer FIG.6 (e) and FIG.6 (f)).

As described above, if it is known that the image is viewed from the viewpoint of the arrow P3, the movement of the distal end portion 2a of the catheter body 2 in the frontward direction A is identified based on the appearance of the first marker portion 11. be able to. However, if it is not known that it is the case seen from the viewpoint of the arrow P3, only the way the first marker portion 11 is seen is seen from the viewpoint of the arrow P1 described above (FIGS. 4A to 4 ( f) can not be distinguished from see). That is, when it is not possible to determine whether the view is from the viewpoint of the arrow P1 or from the view of the arrow P3, the first marker portion 11 has a convex shape on the proximal end side in the central axis direction C. The distal end portion 2a of the catheter body 2 cannot be identified in which direction the rear side A is moving. For example, when the first marker portion 11 looks like a circular arc that is convex toward the proximal side in the central axis direction C, the distal end portion 2a of the catheter body 2 is in the frontward direction A when viewed from the viewpoint of the arrow P1. While moving in the front direction A2 (see FIGS. 4C and 4D), it is moving in the depth direction A1 in the front direction A when viewed from the viewpoint of the arrow P3 (FIG. 6). (E), see FIG. 6 (f)). On the other hand, by providing the second marker portion 12 having an asymmetric shape with respect to the second intermediate virtual surface Y2 (see FIG. 3) passing through the intermediate position of the first marker portion 11 in the circumferential direction B, Based on at least one of the position and shape of the two marker portions 12, it is possible to identify whether it is viewed from the viewpoint of arrow P1 or from the viewpoint of arrow P3. Specifically, in the present embodiment, when the position of the second marker portion 12 is present in the radial direction D with respect to the first marker portion 11, when viewed from the viewpoint of the arrow P <b> 1. It is possible to identify whether there is a view from the viewpoint of the arrow P3. As described above, the second marker portion 12 of the present embodiment identifies whether the view is from the viewpoint of the arrow P1 or from the viewpoint of the arrow P3 based on the shape. I can't.

FIG. 7A shows a state in which the distal end portion 2a of the catheter body 2 is not deformed in the frontward direction A when viewed from the viewpoint of the arrow P4, that is, the distal end portion 2a of the catheter body 2 is in the direction of the arrow P4. It shows a state extending in a direction orthogonal to. The first marker portion 11 is located on the back side of the catheter body 2 in the state shown in FIG. 7A and in the state shown in FIG. 7C and FIG. The position is indicated by a broken line. The distal end portion 2a of the catheter main body 2 in the state shown in FIG. 7A appears as shown in FIG. 7B when viewed from the viewpoint of the arrow P4. As shown in FIG. 7B, when viewed from the viewpoint of the arrow P4, the first marker portion 11 of the marker 3 extends linearly along the radial direction D perpendicular to the central axis direction C. Looks like a shape. Further, as shown in FIG. 7B, when viewed from the viewpoint of the arrow P4, the second marker portion 12 of the marker 3 looks like a shape extending linearly along the central axis direction C.

FIG. 7 (c) shows that the distal end portion 2a of the catheter body 2 when viewed from the viewpoint of the arrow P4, is compared to the state shown in FIG. 7 (a). In (c), it is a downward direction, and shows a state of being deformed in a direction approaching the viewpoint when viewed from the viewpoint of arrow P4. The distal end portion 2a of the catheter main body 2 in the state shown in FIG. 7C looks like the state in FIG. 7D when viewed from the viewpoint of the arrow P4. As shown in FIG. 7D, when viewed from the viewpoint of the arrow P4, the first marker portion 11 of the marker 3 has a convex shape on one side in the radial direction D (lower side in FIG. 7D). It looks like a U shape. As shown in FIG. 7D, when viewed from the viewpoint of the arrow P4, the second marker portion 12 of the marker 3 looks like a shape extending linearly along the central axis direction C. 7D, the position of the second marker portion 12 in the radial direction D is the same as the position of the second marker portion 12 in the radial direction D of FIG. 7B. That is, the shape of the first marker portion 11 in FIG. 7D is different from the shape of the first marker portion 11 in FIG. On the other hand, the position and shape of the second marker portion 12 in FIG. 7 (d) look the same as the position and shape of the second marker portion 12 in FIG. 7 (b).

FIG. 7 (e) shows a depth direction A1 (FIG. 7) in which the distal end portion 2a of the catheter main body 2 is in the depth direction A1 as compared to the state shown in FIG. (E) shows a state of deformation in the upward direction, which is a direction away from the viewpoint when viewed from the viewpoint of arrow P4. The distal end portion 2a of the catheter body 2 in the state shown in FIG. 7 (e) looks like the state in FIG. 7 (f) when viewed from the viewpoint of the arrow P4. As shown in FIG. 7 (f), when viewed from the viewpoint of the arrow P4, the first marker portion 11 of the marker 3 has a convex shape on one side in the central axis direction C (lower side in FIG. 7 (d)). It looks like a U shape. That is, the shape of the first marker portion 11 shown in FIG. 7 (f) is the same as the shape of the first marker portion 11 shown in FIG. 7 (d). As shown in FIG. 7 (f), when viewed from the viewpoint of the arrow P 4, the second marker portion 12 of the marker 3 looks like a shape extending linearly along the central axis direction C. In FIG. 7 (f), the position of the second marker portion 12 in the radial direction D is the same as the position of the second marker portion 12 in the radial direction D of FIGS. 7 (b) and 7 (d). However, the positional relationship in the central axis direction C of the first marker unit 11 and the second marker unit 12 in FIG. 7F is the direction of the central axis of the first marker unit 11 and the second marker unit 12 in FIG. It is different from the positional relationship in C.

Therefore, in the X-ray transmission image acquired by seeing through the X-ray from the direction of the arrow P4 shown in FIG. 3, only by looking at the change in the shape of the first marker portion 11, the distal end portion 2a of the catheter body 2 is It is not possible to identify the movement in the front direction A. However, by confirming the positional relationship of the first marker portion 11 and the second marker portion 12 in the central axis direction C together, the movement of the distal end portion 2a of the catheter body 2 in the frontward direction A can be identified. Specifically, in the marker 3 of the present embodiment, the distal end of the catheter body 2 is confirmed by confirming which end portion of the first marker portion 11 in which the second marker portion 12 looks U-shaped is continuous. The movement of the part 2a in the frontward direction A can be identified. More specifically, the end portion on the distal end side in the central axis direction C of the second marker portion 12 is continuous with the end portion located on the proximal end side in the central axis direction C of the first marker portion 11 that looks U-shaped. (See FIGS. 7C and 7D), it can be identified that the distal end portion 2a of the catheter body 2 is moving in the front direction A2 or has moved. On the other hand, the end on the distal end side in the central axis direction C of the second marker portion 12 is continuous with the end portion located on the distal end side in the central axial direction C of the first marker portion 11 that looks U-shaped. In the case (see FIGS. 7E and 7F), it can be identified that the distal end portion 2a of the catheter body 2 is moving in the depth direction A1 or has moved.

As described above, if it is known that it is the case seen from the viewpoint of the arrow P4, the distal end portion of the catheter body 2 is based on the positional relationship between the first marker portion 11 and the second marker portion 12 in the central axis direction C. It is possible to identify the movement in the forward direction A of 2a. However, unless it is known that it is the case seen from the viewpoint of the arrow P4, only the positional relationship in the central axis direction C of the first marker portion 11 and the second marker portion 12 is seen from the viewpoint of the arrow P2 described above. The case (see FIGS. 5A to 5F) cannot be distinguished. That is, when it is not possible to determine whether the view is from the viewpoint of the arrow P2 or from the view of the arrow P4, the first marker section 11 in which the second marker section 12 appears to be U-shaped. It can not be identified which direction the distal end portion 2a of the catheter main body 2 is moving in the frontward direction A even if it is confirmed which end portion is continuous. For example, when the end portion on the distal end side in the central axis direction C of the second marker portion 12 is continuous with the end portion located on the distal end side in the central axial direction C of the first marker portion 11 that looks U-shaped, The distal end portion 2a of the catheter body 2 moves in the front direction A2 of the front side direction A when viewed from the viewpoint of the arrow P2 (see FIGS. 5 (c) and 5 (d)). This is because when viewed from the viewpoint of P4, it moves in the depth direction A1 in the frontward direction A (see FIGS. 7E and 7F). On the other hand, by providing the first marker portion 11 having an asymmetric shape with respect to the first intermediate virtual surface Y1 (see FIG. 3) passing through the intermediate position of the second marker portion 12 in the circumferential direction B, Based on at least one of the position and the shape of the one marker portion 11, it is possible to identify whether it is viewed from the viewpoint of the arrow P2 or from the viewpoint of the arrow P4. Specifically, in the present embodiment, when the position of the first marker portion 11 is present in the radial direction D with respect to the second marker portion 12, it is viewed from the viewpoint of the arrow P <b> 2. It is possible to identify whether there is a view from the viewpoint of arrow P4. Similarly, in this embodiment, it is a case where it sees from the viewpoint of arrow P2 by confirming which of the shape of the 1st marker part 11 is a convex U-shape toward radial direction D. Or when viewed from the viewpoint of the arrow P4.

4 to 7, the marker 3 is viewed in four viewpoints (see arrows P1 to P4) in which the position of the viewpoint for viewing the distal end portion 2a of the catheter body 2 is changed by 90 degrees in the circumferential direction B by a central angle. As described above, according to the marker 3, not only the four viewpoints but also the viewpoints at different positions in the circumferential direction B can be used to identify the movement of the distal end portion 2a of the catheter body 2 in the frontward direction A. Can do.

Thus, according to the marker 3 of the present embodiment, it is possible to identify the movement of the catheter body 2 in the frontward direction A perpendicular to the projection plane in a fluoroscopic image such as an X-ray fluoroscopic image. However, it is sufficient that the marker 3 has an asymmetric shape with respect to an arbitrary virtual plane Y including the central axis O of the catheter body 2 and parallel to the central axis O. The shape of the marker 3 is the same as that of the present embodiment. It is not limited.

FIGS. 8A to 8G are diagrams showing markers 3a to 3g, which are modifications of the marker 3 of the present embodiment.

The marker 3a shown in FIG. 8A includes a linear first marker portion 11a extending in the circumferential direction B and a linear second marker portion 12a extending in the central axis direction C. . The marker 3a shown in FIG. 8A is different in the formation range in the circumferential direction B of the first marker portion 11a compared to the marker 3 of the embodiment described above (see FIG. 3 and the like). The first marker portion 11 shown in FIG. 3 and the like has a central angle with the central axis O as the center and is formed over a range of 180 degrees in the circumferential direction B, whereas it is shown in FIG. The 1st marker part 11a is a central angle centering on the central axis O, and is formed over the range of 45 degree | times in the circumferential direction B. As shown in FIG. The formation range of the first marker portion may be a central angle centered on the central axis O and may be formed over a range larger than 0 degrees, as shown in FIGS. 3 to 7 and FIG. 8A. Thus, it is preferable to set it as the range of 45 degree | times or more, It is more preferable to set it as the range of 90 degree | times or more, It is especially preferable to set it as the range of 135 degree | times or more. This makes it easier to identify the movement of the catheter body 2 in the frontward direction A (see FIGS. 4 to 7 and the like).

The marker 3b shown in FIG. 8B includes a linear first marker portion 11b extending in the circumferential direction B and a linear second marker portion 12b extending in the central axis direction C. . The marker 3b shown in FIG. 8B is different from the marker 3 of the above-described embodiment (see FIG. 3 and the like) in the position of the first marker portion 11a in the central axis direction C. The first marker portion 11 shown in FIG. 3 and the like is formed on the distal end surface of the distal end portion 2a of the catheter body 2, whereas the first marker portion 11b shown in FIG. The tip portion 2a is formed at a position other than the tip surface. Here, the distal end portion 2 a of the catheter body 2 means, for example, a range within 5 cm from the distal end surface of the catheter body 2 in the central axis direction C. Thus, the position of the first marker portion 11 in the central axis direction C is not limited to the distal end surface of the catheter body 2. However, the first marker portion may be formed on the distal end portion 2a of the catheter body 2 in order to identify the movement of the distal end portion 2a of the catheter body 2 in the frontward direction A (see FIGS. 4 to 7 and the like). Preferably, the distal end portion 2a of the catheter body 2 is more preferably formed within a range of 1 cm from the distal end surface, and particularly preferably formed on the distal end surface of the distal end portion 2a of the catheter main body 2.

The marker 3c shown in FIG. 8C includes a linear first marker portion 11c extending in the circumferential direction B and a wavy second marker portion 12c extending in the central axis direction C. . The marker 3c shown in FIG. 8C is different in the shape of the second marker portion 12c from the marker 3 of the embodiment described above (see FIG. 3 and the like). The second marker portion 12 shown in FIG. 3 and the like has a shape extending linearly along the central axis direction C, whereas the second marker portion 12c shown in FIG. It is the shape extended in the wavy line shape where the position of the circumferential direction B fluctuates as it progresses to C. As described above, if the marker 3c has a configuration that includes the central axis O of the catheter body 2 and has an asymmetric shape with respect to an arbitrary virtual plane Y parallel to the central axis O, the shape of the second marker portion is particularly It is not limited.

Therefore, as shown in FIG. 8D, a linear first marker portion 11d extending in the circumferential direction B and a linear second marker portion 12d extending in the circumferential direction B are provided. The marker 3d may be used. Further, the second marker portion 12d of the marker 3d is disposed at a position separated in the central axis direction C with respect to the first marker portion 11d. As described above, the second marker portion 12d may be arranged at a position separated from the first marker portion 11d in the central axis direction C. However, it is preferable that the second marker portion is continuous with the first marker portion as shown in FIGS. 3 and 8A to 8C. With such a configuration, it is possible to more easily determine a change in the positional relationship of the second marker portion with respect to the first marker portion. Therefore, it becomes easier to identify the movement of the catheter body 2 in the depth direction A (see FIGS. 4 to 7 and the like).

The marker 3e shown in FIG. 8 (e) has a first marker portion 11e extending linearly in a direction inclined with respect to the circumferential direction B, and a second marker disposed at a position separated from the first marker portion 11e. A marker portion 12e. As shown in FIG. 8 (e), the first marker portion extending linearly is not limited to the configuration extending linearly in the circumferential direction B (see FIG. 3 and the like), but is inclined with respect to the circumferential direction B. The 1st marker part 11e extended linearly in the direction to do may be sufficient. However, if the first marker portion linearly extends in the circumferential direction B as shown in FIG. 3 etc., the movement of the catheter main body 2 in the frontward direction A (see FIGS. 4 to 7 etc.) It is easy to confirm the shape change. Specifically, as shown in FIGS. 4 to 7, a shape extending linearly in the radial direction D irrespective of the position of the viewpoint in the circumferential direction B (FIGS. 4A, 5A, 6 (a) and FIG. 7 (a)), the movement of the catheter body 2 in the frontward direction A can be determined based on the change in the shape of the first marker portion 11 therefrom. That is, the catheter body 2 is moving in either the depth direction A1 (see FIGS. 4 to 7 etc.) or the front direction A2 (see FIGS. 4 to 7 etc.) on the projection plane of the fluoroscopic image. It can be identified more reliably.

The marker 3f shown in FIG. 8 (f) is a linear first marker portion 11f extending in the circumferential direction B, and a second portion formed in a different position in the circumferential direction B with respect to the first marker portion 11f. And a marker portion 12f. In the marker 3f shown in FIG. 8F, the first marker portion 11f and the second marker portion 12f are not formed at the same position in the circumferential direction B. In other words, the first marker portion 11f and the second marker portion 12f are not in a positional relationship where they overlap in the central axis direction C. In this case, if the second marker portion 12f has an arbitrary shape different from that of the first marker portion 11f, the entire marker 3f includes the central axis O of the catheter body 2 and an arbitrary virtual plane Y parallel to the central axis O. On the other hand, it has an asymmetric shape. Therefore, the shape of the second marker portion 12f is not limited to the triangular shape shown in FIG. 8F, and may be an arbitrary shape different from the first marker portion 11f.

The marker 3g shown in FIG. 8 (g) is a linear first marker portion 11g extending intermittently in the circumferential direction B, and the circumferential direction B is different from the first marker portion 11g in the central axis direction C. And a linear second marker portion 12g extending intermittently. Thus, the 1st marker part 11g and the 2nd marker part 12g are good also as a linear shape extended intermittently. Each point which comprises the 1st marker part 11g and the 2nd marker part 12g is a center angle centering on the central axis O, and can be made into the range of 30 degrees or more in the circumferential direction B, for example.

As described above, as long as the marker has an asymmetric shape with respect to an arbitrary virtual plane Y including the central axis O of the catheter body 2 and parallel to the central axis O, the shape is not particularly limited. The marker may be composed of, for example, three or more marker portions that are spaced apart.

The distal end portion 2a of the catheter main body 2 shown in FIGS. 1 to 8 is configured to be able to bend and deform in an arbitrary direction with respect to the proximal end portion of the distal end portion 2a. The structure may be capable of bending deformation. Fig.9 (a) is a side view which shows the catheter main body 2 with which the bending direction of the front-end | tip part is restrict | limited, FIG.9 (b) is II sectional drawing of Fig.9 (a). A catheter main body 50 as an elongated body shown in FIG. 9 includes a flexible main body 51, a movable part 52 that is continuous with the distal end side of the main body 51 and can be bent and deformed with respect to the main body 51, I have.

The movable portion 52 includes a first bending direction E1 that is one side of a virtual straight line Q1 passing through the central axis O and a virtual straight line in a cross-sectional view orthogonal to the central axis O of the main body 51 (see FIG. 9B). It can be bent and deformed in the second bending direction E2 which is the other side of Q1. However, the movable part 52 has one side of another virtual straight line Q2 orthogonal to the virtual straight line Q1 passing through the central axis O in a cross-sectional view orthogonal to the central axis O of the main body 51 (see FIG. 9B) and The other side cannot be bent.

Here, the 1st marker part 11 is the circumference containing the 1st surrounding wall part 53 which cross | intersects the virtual straight line Q1 by the side of the 1st bending direction E1 among the surrounding walls of the movable part 52 by sectional view (refer FIG.9 (b)). It is formed in the region in the direction B (the upper region in FIG. 9B). Thus, in the case of the movable part 52 in which the bending direction is limited to a part of the direction, the first marker part 11 formed over a part of the region in the circumferential direction B is a part of the peripheral wall of the movable part 52. It is preferably provided at least on the peripheral wall located on the bending direction side. In this way, even when the bending directions (the first bending direction E1 and the second bending direction E2 in FIG. 9) coincide with the frontward direction A (see FIGS. 4 to 7 and the like), the bending direction can be changed. Easy to identify. The first marker portion 11 shown in FIG. 9 includes a first peripheral wall portion 53 that intersects the virtual straight line Q1 on the first bending direction E1 side in the peripheral wall of the movable portion 52 in a sectional view (see FIG. 9B). It is formed in the region in the circumferential direction B (the upper region in FIG. 9B), but on the second bending direction E2 side of the peripheral wall of the movable portion 52 in a sectional view (see FIG. 9B). It is good also as a 1st marker part formed in the area | region (lower area | region of FIG.9 (b)) of the circumferential direction B containing the 2nd surrounding wall part 54 which cross | intersects the virtual straight line Q1.

As described above, a tubular catheter body as a long body including a marker having an asymmetric shape with respect to an arbitrary virtual plane parallel to the central axis including the central axis of the catheter body as a long body is used. Thus, the bending direction of the catheter body in the frontward direction can be identified. Specifically, as illustrated in FIGS. 4 to 7, based on the appearance of the marker 3 in the fluoroscopic image (see FIG. 2) on which the marker 3 is contrasted, the depth orthogonal to the projection plane of the fluoroscopic image The bending direction of the catheter body 2 in the front direction A can be identified.

By using the identification method shown in the present embodiment, it is possible to identify the movement in the back direction A perpendicular to the projection surface of the catheter body 2 while monitoring the fluoroscopic image during the treatment. Then, as shown in FIG. 10, the movement of the catheter body 2 as a long body in the frontward direction A perpendicular to the projection plane of the fluoroscopic image is identified (identification step S1), and the infarct is considered in consideration of the identification result. A treatment step S2 for performing treatment on a treatment site such as the part Z can be performed. Further, as shown in FIG. 10, whether the treatment is performed in the depth direction A1 in the frontward direction A on the projection surface or the treatment performed in the front direction A2 is displayed on the fluoroscopic image. (Display step S3 in FIG. 10).

In the identification step S1 illustrated in FIG. 10, for example, a control unit configured by a processor or the like of the image display device 100 generates a fluoroscopic image displayed on the display unit 101 (see FIG. 2) such as a liquid crystal monitor of the image display device 100. Can be judged. In addition to this, an image displayed on the display unit 101 may be identified by visual observation by a medical worker such as an operator.

In the display step S3 shown in FIG. 10, a medical worker such as an operator or an assistant inputs the operation by operating an interface such as a keyboard or a touch panel of the image display device 100, and the control unit of the image display device 100 A display operation on the display unit 101 can be executed.

The medical device and the identification method according to the present disclosure are not limited to the specific configurations and processes described in the above-described embodiments and modifications, and various modifications and changes can be made without departing from the scope of the claims. . For example, the marker of the catheter body 2 as a long body is not limited to the configuration shown in FIGS. For example, another marker may be obtained by appropriately combining the first marker portion and the second marker portion of the various markers shown in FIG. In the above-described embodiment, an X-ray fluoroscopic image is used as the fluoroscopic image, and the marker 3 includes a radiopaque material. However, the material is particularly limited as long as it is contrasted in the fluoroscopic image. Is not to be done. Furthermore, part or all of the marker 3 may be configured by a detection unit capable of detecting biological information. That is, the catheter body 2 as an elongated body may include a detection unit that can detect biological information, and at least a part of the marker 3 may be configured by the detection unit. Examples of the detection unit include various sensors and electrodes with high contrast that can detect an electrocardiogram and a heart wall motion. Furthermore, in the above-described embodiment, the catheter 1 is described on the assumption that it is used for treatment in the left ventricle LV of the heart, as shown in FIG. It can be used in various diagnoses and treatments performed while monitoring images. A catheter as a medical device according to the present disclosure can be used for a treatment for an organ having a larger lumen than the outer diameter of the catheter, such as an atrial ventricle of the heart or a digestive organ. Therefore, the catheter as a medical device according to the present disclosure corresponds to the treatment used, for example, infusion catheter, ablation catheter, septal puncture / closure catheter, heart valve replacement catheter, left atrial appendage closure catheter, endoscope An endoscopic catheter can be used.

This disclosure relates to medical devices and identification methods.

1: Catheter (medical device)
2, 50: catheter body (long body)
2a:

distal end portion

3, 3a to 3g of the catheter body:

markers

11, 11a to 11g:

first marker portion

12, 12a to 12g: second marker portion 51: body portion 52: movable portion 53: first peripheral wall portion 54: Second peripheral wall portion 100: Image display device 101: Display portion 200: X-ray imaging device A: Front side direction A1: Depth direction A2: Front side direction B: Circumferential direction of the catheter body (circumferential direction of the long body)
C: The central axis direction of the catheter body (the central axis direction of the long body)
D: Radial direction of the catheter body (radial direction of the long body)
E1: First bending direction E2: Second bending direction O: Center axis of the catheter body (center axis of the long body)
Q1, Q2: Virtual straight line Y: Arbitrary virtual plane Y1: First intermediate virtual plane Y2: Second intermediate virtual plane Z: Infarct including the central axis of the catheter body (the central axis of the elongated body) and parallel to the central axis Part AO: Aorta AV: Aortic valve FA: Femoral artery LV: Left ventricle

Claims

It has a long body with markers,
The marker is a medical device having an asymmetric shape with respect to an arbitrary virtual plane that includes a central axis of the elongated body and is parallel to the central axis.
The marker passes through an intermediate position of the first marker portion in the circumferential direction among the first marker portion formed over at least a partial region in the circumferential direction of the elongated body and the virtual surface. The medical device according to claim 1, further comprising: a second marker portion having an asymmetric shape with respect to the intermediate virtual plane.
The medical device according to claim 2, wherein the first marker portion is formed over a range of 45 degrees or more in the circumferential direction with a central angle centered on the central axis.
The medical device according to claim 2 or 3, wherein the first marker portion extends linearly in the circumferential direction or in a direction inclined with respect to the circumferential direction.
The medical device according to claim 4, wherein the first marker portion extends linearly in the circumferential direction.
The medical device according to any one of claims 2 to 5, wherein the first marker portion is provided at a distal end portion of the elongated body.
The elongate body includes a flexible main body portion, a movable portion that is continuous with the distal end side of the main body portion and is capable of bending deformation with respect to the main body portion,
The movable portion has a first bending direction which is one side of an imaginary straight line passing through the central axis and a second bending direction which is the other side of the imaginary straight line in a cross-sectional view orthogonal to the central axis of the main body. And can be bent and deformed,
The first marker portion includes a first peripheral wall portion that intersects the virtual straight line on the first bending direction side and a virtual straight line on the second bending direction side among the peripheral walls of the movable portion in the sectional view. The medical device according to any one of claims 2 to 6, wherein the medical device is formed in a region in the circumferential direction including any one of the peripheral wall portions intersecting with each other.
The elongated body includes a detection unit capable of detecting biological information,
The medical device according to claim 1, wherein at least a part of the marker is configured by the detection unit.
An identification method for identifying a bending direction of the long body using a long body provided with a marker,
The marker includes a central axis of the elongated body, and has an asymmetric shape with respect to an arbitrary virtual plane parallel to the central axis.
An identification method for identifying a bending direction of the elongate body in a front side direction orthogonal to a projection plane of the fluoroscopic image based on how the marker is seen in a fluoroscopic image in which the marker is contrasted.