JP2023096443A - medical device - Google Patents

Abstract

To provide a medical device capable of acquiring information about a three-dimensional orientation of the device from an angiography image (an x-ray contrast image).SOLUTION: A medical device 1 according to an invention comprises: a first tube 61 which is insertable into a biological lumen; a second tube 62 and a third tube 63 which adjoin the first tube and have guide wire lumens 26 through which a guide wire W is insertable; and a marker 8 which includes a contrast formation part 81 provided integrally with the first tube and having an x-ray contrast property and a transmission part 82 transmitting x-rays therethrough to be displayed differently from the contrast formation part in the x-ray contrast image. The shape of the transmission part is displayed differently in accordance with a posture of the marker in the x-ray contrast image.SELECTED DRAWING: Figure 12

Description

TECHNICAL FIELD The present invention relates to a medical device that can be inserted into a body lumen to acquire image information.

When performing percutaneous coronary intervention (PCI: Percutaneous Coronary Intervention) or percutaneous peripheral angioplasty (PPI: Percutanepous Peripheral Intervention) under the guidance of intravascular ultrasound (IVUS), chronic In cases such as CTO: Chronic Total Occlusion (CTO) cases, the positional relationship between the guide wire and the imaging sensor in the lumen of the ultrasound catheter is confirmed by IVUS images and angiographic images (X-rays) that observe blood vessels from outside the body. A technique is performed to efficiently advance a guide wire to a target position visible in the IVUS image by ascertaining from both the contrast image) and matching the directions of the IVUS image and the angiographic image.

An ultrasound catheter has an imaging sensor for transmitting and receiving ultrasound waves rotatably arranged inside a long shaft. Such an ultrasound catheter rotates an imaging sensor within a shaft portion to transmit ultrasound waves, and also receives signals reflected from living tissue by the same imaging sensor. A tomographic image of the lumen can be drawn by performing processing such as amplification and detection on the received signal.

For example, Patent Literature 1 describes an ultrasound catheter in which a guide wire and an imaging sensor are positioned substantially parallel to each other when ultrasound is transmitted and received by the imaging sensor. In Patent Document 1, by grasping the positional relationship between the guide wire and the imaging sensor in both the IVUS image and the angio image, it is possible to adjust the direction of the angio image, and the direction of the IVUS image and the angio image can be matched. .

JP 2015-119982 A

However, an angio image is a two-dimensional projection image of the imaged range. In conventional methods, when a medical device such as an ultrasound catheter is tilted with respect to the imaging direction and is not facing the imaging direction, three-dimensional information including depth dimensions cannot be obtained from the angiographic image. Can not. The inventors of the present invention have developed a method for obtaining information about the three-dimensional orientation of a medical device such as an ultrasonic catheter, which is tilted with respect to the imaging direction, by obtaining a two-dimensional projection image such as an angiographic image. We are seriously considering how to obtain from. Such considerations may also apply to medical devices other than ultrasound catheters.

The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a medical device capable of acquiring information on the three-dimensional orientation of the device from an angio image (X-ray contrast image). do.

A medical device that achieves the above objectives includes a tubular member, a guidewire sheath, and a marker. The tubular member is configured to be insertable into a biological lumen. The guidewire sheath is provided adjacent to the tubular member and includes a guidewire lumen through which the guidewire can be passed. The marker is provided integrally with the tubular member and includes a contrast formation part having X-ray contrastability and a transparent part that can be displayed differently from the contrast formation part in an X-ray contrast image by transmitting X-rays. The transparent portion may be displayed with different shapes depending on the orientation of the marker in the X-ray contrast image.

According to the medical device configured as described above, it is possible to obtain information about the three-dimensional orientation of the device from an angio image (X-ray contrast image).

It is a top view showing a medical device concerning a 1st embodiment. 1 is a vertical cross-sectional view showing a distal end portion of a medical device according to a first embodiment; FIG. FIG. 3 is a cross-sectional view taken along line AA of FIG. 2; 1 is a plan view showing the hub of the medical device according to the first embodiment; FIG. It is a top view which shows a 1st casing and a 2nd casing. It is the perspective view which expanded a part of 1st casing and 2nd casing. It is a top view which shows an external drive. FIG. 4 is a plan view showing the medical device when the transducer unit is pulled back; FIG. 4 is a perspective view showing a marker provided on the first tubular body (tubular member) of the medical device; FIG. 10 is a front view of the marker shown in FIG. 9 from the penetrating direction of the through holes relating to the first portion and the second portion; 11 is an angio image of FIG. 10; 11 is a perspective view showing a state in which the marker shown in FIG. 10 is rotated with a direction intersecting the axial direction as a rotation axis; FIG. 13 is an angio image of FIG. 12; FIG. 12 is a perspective view showing a state in which the marker shown in FIG. 10 is rotated more than that shown in FIG. 12 with the direction that intersects the axial direction as the axis of rotation; 15 is an angio image of FIG. 14; FIG. 10 is a perspective view of three-dimensionally arranged markers and a guide wire according to a comparative example having no transmitting portion; FIG. 17 shows the marker and guidewire according to FIG. 16 viewed in direction A of FIG. 16; 18 is an angio image of FIG. 17; 1 is a three-dimensional perspective view of markers and guidewires according to the first embodiment; FIG. FIG. 20 is a view seen from the direction B of FIG. 19; 21 is an angio image of FIG. 20; FIG. 10 is a front view of the marker of the medical device according to Modification 1 of the first embodiment from the penetrating direction of the through holes of the first portion and the second portion; FIG. 23 is an angio image of FIG. 22; FIG. 10 is a perspective view showing a state in which the marker according to Modification 1 is rotated about a direction intersecting the axial direction as a rotation axis; FIG. 25 is an angio image of FIG. 24; FIG. 25 is a perspective view showing a state in which the marker according to Modified Example 1 is rotated more than in FIG. 24 with the direction that intersects the axial direction as the rotation axis; FIG. 27 is an angio image of FIG. 26; FIG. 25 is a perspective view showing a state in which the marker according to Modification 1 is rotated in a direction opposite to that in FIG. 24 with the direction intersecting the axial direction as the rotation axis; FIG. 29 is an angio image of FIG. 28; FIG. 11 is a diagram showing a state in which the marker of the medical device according to Modification 2 of the first embodiment is viewed from the direction of penetration of the through holes of the first portion and the second portion; 31 is an angio image of FIG. 30; FIG. 11 is a perspective view showing a state in which a marker according to modification 2 is rotated about a direction intersecting the axial direction as a rotation axis; FIG. 33 is an angio image of FIG. 32; FIG. 11 is a perspective view showing a state in which the marker according to Modification 2 is rotated in the axial direction and in a direction intersecting the axial direction; FIG. 35 is an angio image of FIG. 34; FIG. 10 is a view of the guide wire and the marker according to Modification 2 viewed from the axial direction and the direction intersecting the through hole penetration direction in a state where the guide wire and the marker according to Modification 2 are arranged side by side in the direction intersecting the penetration direction; be. FIG. 37 is a view of the guidewire and the marker according to Modification 2 viewed from the opposite direction to FIG. 36; FIG. 11 is a view of the guide wire and the marker according to Modification 3 viewed from the axial direction and the direction intersecting the penetration direction of the through hole in a state in which the guide wire and the marker according to Modification 3 are arranged side by side in the direction intersecting the penetration direction; be. FIG. 39 is a view of the guidewire and the marker according to Modification 3 viewed from the opposite direction to FIG. 38 ; FIG. 11 is a perspective view showing a marker according to modification 4 of the first embodiment; FIG. 11 is a perspective view of a three-dimensional arrangement of a marker and a guide wire according to Modification 5 of the first embodiment; FIG. 42 is a view of the guide wire and the marker according to modification 5 viewed from direction C in FIG. 41; FIG. 43 is an angio image of FIG. 42;

Hereinafter, embodiments of the present invention will be described with reference to the attached drawings. Note that the following description does not limit the technical scope or the meaning of terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for convenience of explanation, and may differ from the actual ratios.

<First Embodiment>
FIG. 1 is a plan view showing a medical device 1 according to the first embodiment. FIG. 2 is a longitudinal sectional view showing the distal end portion of the medical device 1 according to the first embodiment. FIG. 3 is a cross-sectional view along line AA of FIG. FIG. 4 is a plan view showing the hub 5 of the medical device 1 according to the first embodiment. FIG. 5 is a plan view showing the first casing 531 and the second casing 532. FIG. FIG. 6 is an enlarged perspective view of a part of the first casing 531 and the second casing 532. FIG. FIG. 7 is a plan view showing the external drive device 7. FIG. FIG. 8 is a plan view showing the medical device 1 when the transducer unit 41 is pulled back.

The medical device 1 according to the first embodiment, as shown in FIGS. 1 and 2, is an ultrasound catheter that accommodates an imaging core 4 for ultrasound diagnosis inside and is inserted into a biological lumen. . The medical device 1 is connected to an external drive device 7 (see FIG. 7) that holds the medical device 1 and drives the imaging core 4, and is mainly used for intravascular diagnosis. In this specification, the side to be inserted into the lumen of the living body is called the "distal end" or "distal end side", and the hand side to be operated is called the "proximal end" or "proximal end side".

The medical device 1 includes an elongated shaft portion 2 to be inserted into a lumen, an imaging core 4 (imaging unit) for transmitting and receiving ultrasonic waves to and from the intraluminal tissue, and an imaging core 4 passing therethrough. It has a hub 5 located on the proximal end side of the shaft portion 2 , an operation portion 3 for operating the imaging core 4 , and a marker 8 . Hereinafter, the direction along the axial direction of the shaft portion 2 is referred to as "axial direction X".

The shaft portion 2 includes a shaft distal end portion 21 and a shaft body portion 22 arranged on the proximal end side of the shaft distal end portion 21 as shown in FIG. 1 .

An imaging lumen 25 into which the imaging core 4 is inserted and a guide wire lumen 26 into which the guide wire W is inserted are formed in the shaft distal end portion 21 and the shaft body portion 22 . The image lumen 25 is formed so as to communicate from the shaft distal end portion 21 to the shaft body portion 22 . In this embodiment, the cross-sectional shapes of the imaging lumen 25 and the guide wire lumen 26 are substantially circular.

The guide wire lumen 26 is composed of a first guide wire lumen 27 arranged at the shaft distal end portion 21 and a second guide wire lumen 28 arranged at the shaft body portion 22 . The first guide wire lumen 27 opens at the distal end of the shaft distal end portion 21 and opens on the proximal end side. The first guide wire lumen 27 and the second guide wire lumen 28 are not connected to each other, but are arranged so that the passages of the guide wire W they form are substantially straight. Therefore, the guidewire W can pass through the guidewire lumen 26 in a substantially straight line without bending.

The guide wire W is an elongated body that is flexible and has a substantially constant outer diameter over its entire length. Although the cross-sectional shape of the guide wire W is not particularly limited, it is formed in a substantially circular shape in this embodiment.

The guide wire W can be observed from the outside of the body with an angiographic image obtained by X-ray imaging of the blood vessel. The constituent material of the guide wire W is not particularly limited as long as it can be observed with an angiographic image. For example, metals such as stainless steel, spring steel, titanium, tungsten, tantalum, and superelastic alloys such as nickel-titanium alloys are used. be able to. In this specification, the term "material having X-ray contrast properties" refers to a material having X-ray transparency or a material having X-ray opacity to the extent that it can be observed with an angiographic image.

It should be noted that the central axes of the first guide wire lumen 27 and the second guide wire lumen 28 substantially coincide with the central axis O2 when viewed from the vertical direction. Further, as shown in FIG. 2, the central axis O2 extends along the axial direction X between the first guide wire lumen 27 and the second guide wire lumen 28, even in the portion where the guide wire lumen 26 is not formed. shall exist.

The shaft distal end portion 21 includes a first tubular body 61 (corresponding to an imaging sheath) in which an imaging lumen 25 is formed, and a second tubular body 62 (corresponding to a guidewire sheath) in which a first guidewire lumen 27 is formed. ) are thermally fused (or bonded). The first tubular body 61 is configured to be insertable into a biological lumen. The central axis O1 in FIG. 2 and the like is the central axis of the imaging lumen 25 of the first tubular body 61 .

As shown in FIG. 2 , a reinforcing tube 23 is provided at the distal end of the first tubular body 61 to firmly join and support the second tubular body 62 . The reinforcing tube 23 is a tubular body having a leading end opening 23 a formed through a communication hole 24 that communicates with the imaging lumen 25 . The reinforcing tube 23 is formed by heat-sealing (or bonding) the first tubular body 61 with a material having relatively high rigidity.

The shaft main body 22 is formed such that an imaging lumen 25 and a second guide wire lumen 28 penetrate from the distal end side to the proximal end side. The second guide wire lumen 28 is arranged substantially parallel to the imaging lumen 25 .

As shown in FIG. 4 , the shaft main body 22 includes a shaft intermediate portion 221 in which the imaging lumen 25 and the second guide wire lumen 28 are formed side by side on the distal end side, and a shaft intermediate portion 221 extending toward the proximal direction from the shaft intermediate portion 221 . It has a first shaft base end portion 222 and a second shaft base end portion 223 that branch out from each other. The first shaft proximal end 222 has an imaging lumen 25 formed therein, and the second shaft proximal end 223 has a second guide wire lumen 28 formed therein. The shaft body portion 22 may have different outer diameters and inner diameters depending on the position in the axial direction X. As shown in FIG. For example, by tapering the outer diameter and inner diameter from the proximal side to the distal side to prevent extreme changes in physical properties, high pushability and passability are achieved while suppressing the occurrence of kinks. can do.

The shaft main body 22 is formed by heat-sealing (or bonding) a first tubular body 61 and a third tubular body 63 (corresponding to a guidewire sheath) in which the second guidewire lumen 28 is formed. there is The second tubular body 62 and the third tubular body 63 are provided adjacent to the first tubular body 61 and are configured so that the guide wire W can be inserted therethrough.

The imaging core 4 is slidably arranged in the axial direction X of the shaft portion 2 in the imaging lumen 25 of the first tubular body 61 . As shown in FIG. 2, the imaging core 4 includes a transducer unit 41 for transmitting and receiving ultrasonic waves from the inside of the lumen toward the living tissue, and a drive shaft 42 that attaches the transducer unit 41 to its tip and rotates it. and The transducer unit 41 is composed of an ultrasonic transducer 411 that transmits and receives ultrasonic waves, and a housing 412 that houses the ultrasonic transducer 411 . The transducer unit 41 can be observed with an angio image. Although the material of the housing 412 is not limited, the housing 412 may be made of metal such as gold, platinum, platinum-based alloys, or tungsten-based alloys, or X-ray materials such as barium sulfate, bismuth oxide, or tungsten, so as to function as an X-ray imaging unit. It preferably contains a contrast material. Also, an X-ray contrast marker may be separately provided in the vicinity of the housing 412 .

The first guide wire lumen 27 is provided on the distal end side of the transducer unit 41 of the imaging core 4, and the second guide wire lumen 28 is provided on the rear end side. Therefore, since the guide wire lumen 26 does not exist on the outer peripheral surface of the imaging lumen 25 which is the path of the ultrasonic waves, the transmission and reception of ultrasonic waves by the transducer unit 41 is not hindered by the guide wire lumen 26 .

The shaft tip portion 21 is made of a material having flexibility, and the material is not particularly limited. Examples include various thermoplastic elastomers such as isoprene-based, fluororubber-based, and chlorinated polyethylene-based elastomers, and one or more of these may be used in combination (polymer alloy, polymer blend, laminate, etc.). . The first tubular body 61 in which the imaging lumen 25 is formed is preferably made of a material having high ultrasonic wave permeability.

The shaft main body portion 22 is made of a material having flexibility, and the material is not particularly limited.

The drive shaft 42 is flexible and has characteristics capable of transmitting the rotational power generated in the operation unit 3 to the vibrator unit 41. For example, the drive shaft 42 is a multi-layered coil such as a three-layered coil whose winding directions are alternately right, left, and right. It consists of a coiled tubular body. When the driving shaft 42 transmits rotational power, the transducer unit 41 rotates, and the affected area in a lumen such as a blood vessel can be observed in the circumferential direction. Further, a signal line 43 for transmitting a signal detected by the vibrator unit 41 to the operation unit 3 is passed through the drive shaft 42 .

The hub 5 includes a first hub portion 51 airtightly connected to the first shaft base end portion 222, a second hub portion 52 airtightly connected to the second shaft base end portion 223, the first hub portion 51 and A hub casing 53 covering the second hub portion 52 and a first anti-kink protector 54 are provided.

The first hub portion 51 is connected with the operating portion 3 that is connected to the external driving device 7 to operate the imaging core 4 . The operating portion 3 includes an outer tube 32 connected to the first hub portion 51, a unit connector 37 connected to the base end portion of the outer tube 32, and an inner tube movable in the axial direction X with respect to the outer tube 32. 34 and an operating proximal end 31 connected to the proximal end of the inner tube 34 .

Manipulating proximal end 31 holds drive shaft 42 and inner tube 34 . By moving the operating proximal end portion 31 and pushing the inner tube 34 into the unit connector 37 and the outer tube 32 (see FIG. 1) or pulling it out (see FIG. 8), the drive shaft 42 is interlocked with the shaft. It slides in the axial direction X within the portion 2 . A port 311 for injecting a physiological saline solution for priming is formed in the operation proximal end portion 31 . The port 311 communicates with the imaging lumen 25 .

When the inner tube 34 is pushed to the maximum, the tip end of the inner tube 34 moves inside the outer tube 32 and reaches the vicinity of the first hub portion 51 as shown in FIG. 1 . In this state, the transducer unit 41 is positioned near the tip of the imaging lumen 25 as shown in FIG.

Also, when the inner tube 34 is pulled out to the maximum, as shown in FIG. 8, the stopper 315 formed at the tip of the inner tube 34 is caught on the inner wall of the unit connector 37, exposing the part other than the tip near the tip. Then, in this state, the vibrator unit 41 is pulled back inside while leaving the shaft portion 2 . Thus, the transducer unit 41 can move along the axial direction X while rotating inside the imaging lumen 25 in order to create a tomographic image of a blood vessel or the like.

The operation proximal end portion 31 has a joint 312 , a hub-side connector 313 connected to the proximal end portion of the drive shaft 42 , and a second anti-kink protector 314 .

The joint 312 has an opening on the proximal end side, and the hub-side connector 313 is arranged inside. The hub-side connector 313 can be connected to a drive-side connector 711 (see FIG. 7) of the external drive device 7 from the base end side of the joint 312. By connecting, the external drive device 7 and the hub-side connector 313 can be connected. are mechanically and electrically connected.

One end of a signal line 43 is connected to the hub-side connector 313, and as shown in FIG. there is Ultrasonic waves are emitted from the transducer unit 41 by signals transmitted from the external drive device 7 to the transducer unit 41 via the drive-side connector 711 , the hub-side connector 313 and the signal line 43 . Signals detected by the transducer unit 41 by receiving ultrasonic waves are transmitted to the external drive device 7 via the signal line 43 , the hub-side connector 313 and the drive-side connector 711 .

The second anti-kink protector 314 is arranged around the inner tube 34 and the operating proximal end portion 31 to suppress kinking of the inner tube 34 .

The unit connector 37 is inserted so that the proximal end portion of the outer tube 32 attached to the first hub portion 51 is fitted therein. 34 is inserted. The unit connector 37 can be connected to the holding portion 73 (see FIG. 7) of the external drive device 7 .

As shown in FIGS. 1 and 4, the first hub portion 51 is connected to the distal end portion of the outer tube 32 from the proximal end side, and the first shaft proximal end portion 222 is inserted from the distal end side. are connected in an airtight manner by heat sealing or gluing. Accordingly, drive shaft 42 and saline passing through inner tube 34 and outer tube 32 can travel through first hub portion 51 to imaging lumen 25 . A ring-shaped projection 511 for connection is formed on the outer peripheral surface of the first hub portion 51 so as to be connected to the hub casing 53 .

The second hub portion 52 is airtightly connected with the second shaft base end portion 223 inserted from the tip side and heat-sealed or adhered. Therefore, the second hub portion 52 communicates with the guidewire lumen 26 and allows the guidewire W to pass therethrough. A second connecting projection 521 projecting in a ring shape is formed on the outer peripheral surface of the second hub portion 52 in order to connect to the hub casing 53 .

As shown in FIGS. 4 to 6, the hub casing 53 is composed of two split mold structures that sandwich the outer peripheral surfaces of the shaft main body 22, the first hub portion 51 and the second hub portion 52 from both sides. A first casing 531 and a second casing 532 are provided. The first casing 531 and the second casing 532 are formed in a symmetrical shape with the shaft body portion 22, the first hub portion 51 and the second hub portion 52 interposed therebetween. The first casing 531 and the second casing 532 are composed of a tip side fitting portion 533 to which the shaft body portion 22 is fitted, a first hub fitting portion 534 to which the first hub portion 51 is fitted, and a second hub portion. A second hub fitting portion 535 into which the second hub 52 is fitted is formed.

The first hub fitting portion 534 is formed with a first connecting concave portion 536 into which the first connecting convex portion 511 formed on the outer peripheral surface of the first hub portion 51 can be fitted. The second hub fitting portion 535 is formed with a second connecting concave portion 537 into which the second connecting convex portion 521 formed on the outer peripheral surface of the second hub portion 52 can be fitted.

The first casing 531 and the second casing 532 have connecting hooks that are connected so as to be hooked by overlapping the outer peripheral surfaces of the shaft body portion 22, the first hub portion 51 and the second hub portion 52 so as to sandwich them from both sides. 538 and a connecting stepped portion 539 are formed. By stacking the first casing 531 and the second casing 532 , the connecting hook 538 is once bent and then caught on the connecting stepped portion 539 , thereby connecting the first casing 531 and the second casing 532 . It should be noted that the first casing 531 and the second casing 532 may be joined by an adhesive or heat-sealing without using a mechanical structure such as the connecting hook 538 and the connecting stepped portion 539 .

The first connecting projection 511 of the first hub portion 51 fits into the first connecting recess 536 , and the second connecting projection 521 of the second hub portion 52 fits into the second connecting recess 537 . When the first casing 531 and the second casing 532 are connected in a combined state, the first hub portion 51 and the second hub portion 52 are fixed to the hub casing 53 so as not to fall off. The first hub portion 51 and the hub casing 53 are joined by an adhesive or heat-sealing without using a mechanical structure such as the first connecting convex portion 511 and the first connecting concave portion 536. good too. The second hub portion 52 and the hub casing 53 are also joined by adhesive or heat sealing without using a mechanical structure such as the second connecting projection 521 and the second connecting recess 537. good too.

A portion of the shaft main body 22 that branches from the shaft intermediate portion 221 toward the proximal direction into a first shaft proximal end portion 222 and a second shaft proximal end portion 223 is located inside the hub casing 53 . For this reason, the first shaft base end portion 222 and the second shaft base end portion 223, which are lower in rigidity than the shaft intermediate portion 221 because the first tubular body 61 and the third tubular body 63 are not joined, are formed into the hub casing. It is not positioned outside 53 and can exhibit high pushability.

In the hub casing 53, the axis of the base end of the shaft main body 22 is defined as a reference line X1, and the inclination |θ1| of the center axis Y2 of the portion 52 is larger than the inclination |θ2|

If the inclination |θ1| In addition, when the imaging core 4 is pulled back, disconnection and image unevenness due to jumping that disturbs the movement of the imaging core 4 are likely to occur. Therefore, it is preferable that the inclination |θ1|

If the inclination |θ2|

Therefore, considering the above points, it is preferable that |θ1|≈0 and |θ2|≈0. However, the smaller the value of the angle |θ1-θ2| , the value of |θ1−θ2| should be as large as possible.

Also, since the stiffness of the guidewire W is typically much higher than the stiffness of the drive shaft 42, |θ2|≈0 is preferred. In this embodiment, |θ2|=0 and |θ1|>0. Note that |θ2| may be greater than or equal to |θ1|.

The drive shaft 42, which should generally be arranged so as not to bend within the hub, is arranged to bend within the hub 5 in this embodiment. In addition, since the drive shaft 42 is configured to be able to transmit the driving force while bending inside the blood vessel, bending inside the hub 5 is allowed. Since the first shaft proximal end portion 222 formed with the image lumen 25 that houses the drive shaft 42 extends while bending in the hub casing 53 and is connected to the first hub portion 51, the hub The position of the drive shaft 42 rotating within the casing 53 can be properly held.

Also, the second shaft proximal end portion 223 in which the guide wire lumen 26 for accommodating the guide wire W is formed is connected to the second hub portion 52 inside the hub casing 53 . Therefore, the position of the guide wire W can be appropriately held within the hub casing 53, and the guide wire W can be operated satisfactorily.

As shown in FIG. 1, the first anti-kink protector 54 surrounds the distal end portion of the hub casing 53 and the shaft main body portion 22 leading out from the hub casing 53 in the distal direction, thereby suppressing the kink of the shaft main body portion 22. .

The constituent materials of the first hub portion 51, the second hub portion 52, the hub casing 53, the outer tube 32, the inner tube 34, the unit connector 37, and the operating proximal end portion 31 are not particularly limited. Polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly-(4-methylpentene-1), polycarbonate, acrylic resin, polyester such as acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate, polyethylene naphthalate, butadiene-styrene copolymer Various resins such as coalescence, polyamide (eg, nylon 6, nylon 6.6, nylon 6.10, nylon 12) can be mentioned.

FIG. 9 is a perspective view showing the marker 8 provided on the first tubular body 61 of the medical device 1, and FIG. 10 is a front view of the marker 8 from the penetrating direction of the through holes relating to the first portion 83 and the second portion 84. FIG. 11 is an angio image of FIG. 12 is a perspective view of the marker 8 rotated from the state shown in FIG. 10 with the direction Y intersecting with the axial direction X as the rotation axis, and FIG. 13 is an angio image of FIG. 14 is a perspective view showing a state in which the marker 8 is rotated from FIG. 12 with the direction Y as the rotation axis, and FIG. 15 is an angio image of FIG.

As shown in FIGS. 10 and 11, the first tubular body 61 is integrally provided with the marker 8 embedded in the reinforcing tube 23 provided at the tip. The marker 8 is configured to include a contrast formation section 81 and a transmission section 82 as shown in FIG. The contrast formation unit 81 is configured to have X-ray contrast properties by making it possible to display shadows in the angiographic image using a material or the like to be described later. Unlike the contrast formation section 81, the transmission section 82 transmits X-rays in the angio image and is displayed differently from the contrast formation section 81 in the angio image. The transmissive portion 82 is configured so that the shape of the transmissive portion 82 varies depending on the orientation of the marker 8 in the angio image.

In the present embodiment, the contrast formation part 81 is configured to include a hollow cylindrical shape (corresponding to the first member) capable of displaying shadows in an angio image as shown in FIG. The transmitting portion 82 is configured to include a hollow cylindrical through-hole. The transmission portion 82 includes a first portion 83 and a second portion 84 . The first portion 83 is configured to be provided on the outer surface of the marker 8 . The first portion 83 includes one hollow cylindrical through-hole in this embodiment. The second portion 84 is a portion different from the first portion 83 on the outer surface of the marker 8 and includes one through hole communicating with the first portion 83 when viewed from one direction (direction Z).

The direction Y and the direction Z shown in FIG. 9 and the like correspond to the remaining two coordinate axes when the axial direction X is taken as one of the coordinate axes in the orthogonal coordinate system in this specification.

As shown in FIGS. 9, 10, etc. in the present embodiment, the through-holes relating to the first portion 83 and the second portion 84 are both substantially circular in shape when viewed from the front in the penetrating direction of the through-holes. . The first portion 83 and the second portion 84 have the same shape when viewed from the direction Z corresponding to the penetrating direction of the through hole as shown in FIGS. 9 to 11 in this embodiment. The penetration direction of the through holes of the first part 83 and the second part 84 intersects the axial direction X, and is relative to the direction Y in which the first tubular body 61, the second tubular body 62 and the third tubular body 63 are arranged. It is configured along the direction Z that intersects with the

Here, a method of obtaining information about the orientation of the medical device 1 by the transmissive portion 82 of the marker 8 will be described. As described above, the penetrating directions of the through-holes relating to the first portion 83 and the second portion 84 constituting the transmitting portion 82 are both formed along the direction Z. As shown in FIG. When the marker 8 is viewed from the front in the penetrating direction of the first part 83 and the second part 84, as shown in FIG. It looks as it is. This also applies to the angio image shown in FIG.

Here, when considering tilting the marker 8 from the front view state as shown in FIG. The position does not change from the state shown in FIG. 10 or the like. Therefore, in this specification, "tilt" corresponds to the penetration direction of the through-hole of the transmission part when the penetration direction of the through-hole related to the transmission part is one of the coordinate axes, such as the direction Z in the orthogonal coordinate system. It means to rotate an object such as the medical device 1 by using a coordinate axis other than the coordinate axis to be the axis of rotation.

When the marker 8 is tilted in a specific direction as shown in FIG. 12 from a state in which the marker 8 is viewed from the front in the penetrating (extending) direction of the through holes such as the first portion 83, the contour shape of the transmitting portion 82 is shown in FIG. As shown, the first part 83 constitutes a part, and the second part 84 constitutes the rest. The operator can acquire three-dimensional information about the tilt of the medical device 1 including the marker 8 from the positional relationship between the first portion 83 and the second portion 84 in the transmissive portion 82 .

Here, as an example, a method of obtaining information about the tilt of the medical device 1 from an angio image when the medical device 1 including the marker 8 is rotated with the direction Y as the rotation axis will be described.

As shown in FIGS. 10 to 15, when the marker 8 is rotated with the direction Y as the axis of rotation, the shape of the transmissive portion 82 in the angio image changes from a true circular shape when viewed from the front, with points P1 and P2 as boundaries. It deforms like a shape connecting two circular arcs (see FIG. 13). The operator can recognize that the first part 83 and the second part 84 are arranged side by side in FIG. 13 with the points P1 and P2 as boundaries. The fact that the first part 83 and the second part 84 are arranged in the left-right direction means that the medical device 1 including the marker 8 rotates mainly about the direction Y as the rotation axis, and does not rotate about the axial direction X as the rotation axis. Alternatively, it can be determined that the rotation is almost non-existent.

As shown in FIGS. 14 and 15, when the marker 8 is further rotated in the direction Y from the state shown in FIGS. 12 and 13, the state in which the first portion 83 and the second portion 84 are aligned horizontally in the angio image does not change. . However, the shape of the transmission portion 82 including the first portion 83 and the second portion 84 is even smaller than the shape of the transmission portion 82 in FIG. Assuming that the rotation angle of the transparent portion 82 is 0 degrees when viewed from the front, the outline shape of the transparent portion 82 monotonically decreases as the marker is rotated from 0 degrees to ±90 degrees. 13 and 15, the medical device 1 including the marker 8 in the state shown in FIG. 15 rotates in the direction Y more than the state shown in FIG. It can be determined that

Also, as in the case where the direction Y is the axis of rotation, the points P1 and P2, which are the boundaries between the first part 83 and the second part 84, are aligned in the horizontal direction in the angio image, and the first part 83 and the second part 84 are arranged vertically (not shown). In this case, the operator rotates the medical device 1 including the marker 8 in the angio image mainly about the axial direction X corresponding to the lateral direction, which is a direction other than the direction Z, which is the depth direction, as the rotation axis. It can be determined that there are

Furthermore, the points P1 and P2, which are the boundaries between the first portion 83 and the second portion 84, are arranged obliquely in the angio image, the first portion 83 being arranged obliquely upward, and the second portion 84 being arranged obliquely downward. (not shown). In this case, the operator can determine that the rotation axis of the medical device 1 including the marker 8 is the axial direction X and the direction Y, which are directions other than the direction Z, which is the depth direction. In this way, the operator can acquire information about the inclination of the marker 8 from the arrangement of the first part 83 and the second part 84 in the outline of the transparent part 82 in the angio image, the size of the transparent part 82, and the like. In this way, when the operator tilts the marker 8, the angiographic image of FIG. 13 and FIG. It can be used as a reference for acquiring information about the inclination of the medical device 1 including the device.

Further, when the shape of the first part 83 and the second part 84 of the transmissive part 82 when viewed from the front is circular as in the present embodiment, the operator can In recognizing the arrangement, the positions of the points P1 and P2 described above can be referred to.

Using the determination method described above, the operator can tilt the marker 8 from the front view state, or tilt the marker 8 from the current position even in a direction other than the front view direction, thereby changing the shape of the transparent portion 82 in the angio image. to observe. Thereby, it can be determined that the medical device 1 including the marker 8 is tilted in at least one of the axial direction X and the direction Y orthogonal to the axial direction X.

The constituent material of the marker 8 is not particularly limited as long as it can be observed with an angiographic image. It preferably contains a toxic material.

The medical device 1 described above is connected to and driven by an external drive device 7, as shown in FIG. The external drive device 7 includes a drive unit 71 that incorporates an external drive source such as a motor and drives the drive shaft 42 to rotate, and a drive unit 71 that is held and moved in the axial direction X by the motor or the like. It has a moving means 72 and a holding portion 73 that holds a part of the medical device 1 in a fixed position. The external driving device 7 is connected to a control section 79 that controls the driving section 71 and the moving means 72, and the image obtained by the transducer unit 41 is displayed on the display section 78 connected to the control section 79. .

The moving means 72 is a feeding mechanism capable of gripping and fixing the driving portion 71 and moving the gripped driving portion 71 back and forth along grooved rails 76 on the base 75 .

The drive unit 71 has a drive-side connector 711 to which the hub-side connector 313 of the medical device 1 can be connected, and a joint connection portion 712 to which the joint 312 of the medical device 1 can be connected. Signals can be transmitted and received to and from the child unit 41, and at the same time, the drive shaft 42 can be rotated.

The control unit 79 includes processors such as a CPU (Central Processing Unit) and GPU (Graphics Processing Unit), main storage such as memory, auxiliary storage such as HDD (Hard Disc Drive) and SSD (Solid State Drive).

Ultrasonic scanning (scanning) in the medical device 1, as shown in FIGS. to rotate the housing 412 fixed to the tip of the drive shaft 42 . As a result, the ultrasonic transducer 411 provided in the housing 412 rotates while moving in the axial direction X, and the ultrasonic waves transmitted and received by the ultrasonic transducer 411 can be scanned substantially in the radial direction. As a result, a 360° tomographic image of the surrounding tissue extending in the axial direction within the blood vessel can be obtained by scanning up to an arbitrary position.

Next, the operation of observing a biological tissue from within a biological lumen such as a blood vessel using the medical device 1 according to the first embodiment will be described.

First, before inserting the shaft portion 2 of the medical device 1 into the lumen, the operator performs a priming operation to fill the inside of the medical device 1 with physiological saline. By performing the priming operation, ultrasonic waves can be transmitted from the ultrasonic transducer 411, air in the medical device 1 is removed, and air is prevented from entering lumens such as blood vessels.

For priming, as shown in FIG. 8, the operator pulls the operating proximal end portion 31 from the unit connector 37 to the proximal end side, that is, the state in which the inner tube 34 is most pulled out from the outer tube 32. to Then, the operator injects a physiological saline solution using, for example, a syringe or the like through an instrument consisting of a tube (not shown) and a three-way stopcock connected to the port 311 of the operation proximal end portion 31 . The injected physiological saline passes through the first hub portion 51 from the operating proximal end portion 31 and fills the imaging lumen 25, and the physiological saline is discharged from the distal end opening 23a. This confirms the filling of the saline and completes the priming.

Next, as shown in FIG. 7, the operator connects the medical device 1 to an external driving device 7 covered with a sterilized polyethylene bag (not shown). That is, the operator connects the joint 312 of the operation proximal end portion 31 of the medical device 1 to the joint connection portion 712 of the driving portion 71 . As a result, signals can be transmitted and received between the vibrator unit 41 and the external drive device 7, and at the same time, the drive shaft 42 can be rotated. Then, when the unit connector 37 is fitted into the holding portion 73, the connection is completed.

Next, the operator inserts the guide wire W into the blood vessel through the sheath percutaneously inserted into the blood vessel by the Seldinger technique. Next, the operator inserts the proximal end portion of the guide wire W from the distal opening 27a of the first guide wire lumen 27, passes through the distal opening 28a of the second guide wire lumen 28, and passes through the distal opening 28a of the second guide wire lumen 28. insert inside.

After leading out the guide wire W from the second hub portion 52 to the proximal end side, the operator pushes the medical device 1 along the guide wire W to move the distal end portion of the medical device 1 deeper than the affected area to be observed. side (tip side). At this time, since the first hub portion 51 and the second hub portion 52 are oriented in different directions, the operator can operate the guide wire W without being interfered with by the operation portion 3 or the external driving device 7. . Moreover, since the guide wire lumen 26 is open at the second hub portion 52 at hand, it is not wetted by blood leaking from the sheath, and the guide wire W can be easily replaced. Therefore, by properly using guide wires W having arbitrary loads and shapes, it is possible to allow the medical device 1 to efficiently reach deep parts of complicated parts. In addition, since the guidewire lumen 26 is open at the second hub portion 52 at hand, it is also possible to supply a contrast agent or a drug through the guidewire lumen 26 and release it into the living body from the tip opening 28a. can.

In this state, the operator holds the shaft portion 2 so that it does not move, and moves the driving portion 71 toward the distal side along the grooved rail 76 on the base 75 (see FIG. 7). The portion 31 is moved to the distal end side so that the inner tube 34 is pushed most into the outer tube 32 . Thereby, as shown in FIG. 2, the imaging core 4 moves to the distal end side of the imaging lumen 25 .

Next, the operator obtains an angiographic image by X-ray photography from outside the body. The operator observes changes in the shape and size of the transparent portion 82 of the marker 8 while moving the distal end portion of the medical device 1 to see how the medical device 1 behaves in the angiographic image as described above. You can get information about how you are leaning towards.

Next, as shown in FIG. 8, the operator performs a pullback operation while rotating the drive shaft 42 by the drive unit 71, thereby radially scanning the ultrasonic transducer 411 toward the base end side of the affected area in the axial direction X. move along. Then, the operator continuously acquires tomographic images of the living tissue including the affected area along the axial direction X of the lumen.

By providing the transducer unit 41, the marker 8 that can be imaged by X-rays from outside the body, and the guide wire W, the medical device 1 can be accurately moved within the body lumen.

After that, the medical device 1 is withdrawn from the blood vessel, and the operation of the medical device 1 is completed.

As described above, the medical device 1 according to the first embodiment has the first tubular body 61 , the second tubular body 62 and the third tubular body 63 , and the marker 8 . The first tubular body 61 is configured to be insertable into a biological lumen. The second tubular body 62 and the third tubular body 63 are provided adjacent to the first tubular body 61 and have a guide wire lumen 26 through which the guide wire W can be inserted. The marker 8 is provided integrally with the first tubular body 61 and includes a contrast formation portion 81 having X-ray contrastability and a transmission portion that can be displayed differently from the contrast formation portion 81 in an angio image by transmitting X-rays. 82 and. The transmissive portion 82 is configured so that the shape is displayed differently depending on the orientation of the marker 8 in the angio image.

FIG. 16 is a three-dimensional perspective view of a guide wire W and a marker M according to a comparative example that does not have a transmitting portion 82. FIG. 17 is a perspective view of the marker M and guide wire W in FIG. FIG. 18 is an angio image of FIG. FIG. 19 is a perspective view of a three-dimensional arrangement of the marker 8 and the guide wire W according to this embodiment, FIG. 20 is a view seen from the direction B in FIG. 19, and FIG. 21 is an angiographic image of FIG.

When the marker M is tilted with respect to the imaging direction of the angio image as shown in FIG. 17, even if the marker M is moved from the state shown in FIG. Depth information cannot be obtained from the deformation. Therefore, the operator cannot recognize that the guide wire W or the like is arranged at an angle with respect to the imaging direction of the angio image.

On the other hand, since the marker 8 according to the present embodiment includes the transmission part 82 in addition to the contrast formation part 81, the shape of the transmission part 82 is changed like the angio image in FIG. The direction (inclination) of the marker 8 can be recognized from the angle and the size. Since the marker 8 is integrated with the medical device 1, the operator can obtain information about the three-dimensional orientation of the distal end of the medical device 1 by using the marker 8 including the transparent portion 82, as a two-dimensional image such as an angiographic image. It can be determined from the projected image.

By acquiring the three-dimensional positional information of the medical device 1 in this way, the procedure time using the medical device 1 can be shortened. Further, since the first tubular body 61 is arranged adjacent to the second tubular body 62 and the third tubular body 63, the transparent portion 82 of the marker 8 is hidden by the guide wire W even if the medical device 1 is tilted to some extent. very rarely. In this way, the operator can grasp the three-dimensional orientation of the medical device 1 by observing the transparent portion 82 of the marker 8 in a state where it does not overlap the guide wire W. It should be noted that the tilt of the medical device 1 according to this embodiment can be easily grasped when the device is rotated from a state viewed from the front in the penetrating direction of the first portion 83 and the second portion 84 as shown in FIG. .

In addition, data of the shape and size (area) of the transmissive portion 82 in a state in which the transmissive portion 82 is tilted in at least one of the axial direction X, the direction Y, and the direction Z with respect to the direction in which the transmissive portion 82 is viewed from the front is obtained as described above. It may be configured to be stored in a storage unit such as an auxiliary storage of the control unit 79 . The data to be stored in a storage unit such as an auxiliary memory is a set of rotation angles in the axial direction X, direction Y, and direction Z with respect to the transparent portion 82 viewed from the front, and image data at the rotation angles. can be done.

The control unit 79 compares the angio image captured by the processor or the like with the image data stored in the storage unit, and finds image data that matches the captured angio image from the image data stored in the storage unit. The image data stored in the storage unit is stored as a set with the data of the rotation angles in the axial direction X, direction Y, and direction Z with respect to the state viewed from the front. Therefore, by matching the image data included in the data set in the storage unit with the angio image, the inclination of the object in the angio image can be specified from the angle information corresponding to the image data in the storage unit that matches the angio image.

The operator can generally grasp the scale of the imaging range of the angio image. Therefore, by measuring the movement distance of the device in the angio image from the angio image and considering the angles with respect to the axial direction X, the direction Y, and the direction Z obtained by matching with the angio image, the blood vessel length and the like can be calculated with high accuracy. In this way, by obtaining information such as the depth direction of the object using the marker 8, three-dimensional information of the object such as blood vessels can be obtained from the two-dimensional projection image.

In addition, the transmissive portion 82 is a first portion 83 formed on the outer surface of the marker 8, and a portion different from the first portion 83 on the outer surface. A second portion 84 is provided that communicates with the first portion 83 . By configuring in this way, the contour shape of the transmissive portion 82 in the angio image can be changed according to the orientation of the medical device 1 , thereby obtaining information on the orientation (inclination) of the medical device 1 .

Also, the first portion 83 is formed in the same shape as the second portion 84 when viewed from one direction such as the Z direction. By configuring in this way, the shape of the transparent portion 82 can be changed in the angio image according to the orientation of the marker 8, and information regarding the orientation (inclination) of the medical device 1 can be obtained.

The contrast formation part 81 has a first member capable of displaying shadows in an angio image like the hollow cylindrical shape described above, and the transmission part 82 has a cylindrical shape like the first part 83 and the second part 84. provided with a through hole provided on the side surface of the With this configuration, the shape of the transmissive portion 82 in the angio image is changed according to the orientation of the marker 8, and information regarding the orientation (inclination) of the medical device 1 is obtained by observing the change in the shape of the transmissive portion 82. can be obtained. Since the transmissive portion 82 is observed not as the length of the marker but as a hole (shape) that is not contrast-enhanced in the angiographic image, it can be easily identified by the operator.

Further, the first tubular body 61 corresponds to an imaging sheath provided with an imaging lumen into which the drive shaft 42 capable of moving in the rotational direction and the axial direction X is inserted so as to move back and forth. The marker 8 is configured to be embedded in the reinforcing tube 23 provided at the tip of the first tubular body 61 . With this configuration, it is possible to acquire information about the three-dimensional orientation (inclination) of the distal end portion of the diagnostic imaging catheter of the present embodiment.

<Modification 1 of the first embodiment>
FIG. 22 is a front view of the marker 8a in Modification 1 of the first embodiment from the penetrating direction of the through holes of the first portion 83a and the second portion 84a of the transmissive portion 82a, and FIG. 23 is an angio-image of FIG. is. FIG. 24 is a perspective view showing a state in which the marker 8a is rotated with the direction Y as the rotation axis, and FIG. 25 is an angio image of FIG. FIG. 26 is a perspective view showing a state in which the marker 8a is rotated from FIG. 24 with the direction Y as a rotation axis, and FIG. 27 is an angio image of FIG. FIG. 28 is a perspective view showing a state in which the marker 8a is rotated opposite to FIG. 24 with the direction Y as the rotation axis, and FIG. 29 is an angio image of FIG.

In the first embodiment, the through-holes of the first portion 83 and the second portion 84 of the marker 8 have the same shape when viewed from the direction Z corresponding to the through-hole direction in the hollow cylindrical shape. . However, if the marker has a contrast formation part and a transparent part whose shape and size change depending on the posture of the marker, the first part and the second part are configured so that the shapes of the through-holes when viewed from the penetrating direction are different. good too.

In this modified example, as shown in FIG. 22 and the like, the first portion 83a is formed in a hollow cylindrical shape related to the contrast formation portion 81a in the same manner as in the first embodiment, and the shape when viewed from the direction Z is a substantially perfect circle. Contains holes. On the other hand, the second portion 84a is formed in a hollow cylindrical shape and configured to include a substantially rectangular through hole when viewed from the direction Z. As shown in FIG. Since this modification differs from the first embodiment only in the shape of the second portion 84a, a detailed description of the contrast formation portion 81a and the transmission portion 82a will be omitted.

Here, a method of obtaining information about the inclination of the medical device including the marker 8a from the angio image when the marker 8a is rotated with the direction Y as the rotation axis will be described. First, let us consider a case where the tip side of the marker 8a rotates toward the front side as shown in FIG. 24 with the direction Y in FIG.

In this case, as shown in the angio images of FIGS. 25 and 27, the shape of the transparent portion 82 is such that one side of the rectangle of the second portion 84a can be confirmed on the right side, and the arc shape of the first portion 83a can be confirmed on the left side. . When a rectangular shape such as the second portion 84a appears as the contour shape of the transparent portion, if the marker is tilted, the vertical and horizontal sides of the rectangular shape appear as the contour shape of the transparent portion.

On the other hand, as shown in FIGS. 25 and 27, the fact that the horizontal sides of the rectangular shape do not appear means that the medical device including the marker 8a is not tilted from the front view state (the state of FIG. 22). can be determined. The fact that only the vertical sides of the rectangular shape constitute the outline of the transmissive portion 82a means that the medical device including the marker 8a rotates about the vertical direction (direction Y) in the angio image as the axis of rotation. Furthermore, in this modified example, the medical device including the marker 8a is rotated with the circular first portion 83a arranged on the front side.

Therefore, if the arc shape of the first portion 83a is located on the left side of the transparent portion as shown in FIG. 25, the medical device including the marker 8a is tilted so that the tip side, which is the left side of the angio image shown in FIG. It can be determined that When the marker is rotated from the front view state shown in FIG. 22 about the direction Y as the rotation axis, if the rotation angle in FIG. It can be judged that the size of the shape of is smaller. Therefore, in the state of FIG. 27, it can be determined that the medical device including the marker 8a is rotated in the direction Y from the front view rather than the state of FIG. On the contrary, when the arc-shaped first portion 83a is positioned on the right side of the transparent portion 82a as shown in FIG. You can tell that it is rotating.

Thus, in this modification, the first portion 83a and the second portion 84a are configured to have different shapes when viewed in the Z direction. By making the shapes of the first portion 83a and the second portion 84a different in this way, when the marker 8a is tilted, the distal end side of the medical device including the marker 8a is tilted toward either the near side or the far side in the angiographic image. can determine whether

<Modification 2 of the first embodiment>
FIG. 30 is a front view of the marker 8b according to Modification Example 2 of the first embodiment viewed from the penetrating direction of the through holes of the first portion 83b and the second portion 84b, and FIG. 31 is an angio-image of FIG. FIG. 32 is a perspective view of the marker 8b rotated about the direction Y intersecting the axial direction X, and FIG. 33 is an angio image of FIG. FIG. 34 is a perspective view of the marker 8b rotated with the axial direction X and the direction Y as rotation axes, and FIG. 35 is an angio image of FIG. 36 is a view of the marker 8b and the guide wire W arranged side by side in the direction Y, viewed from one side in the direction Y, and FIG. 37 is a view of the marker 8b and the guide wire W shown in FIG. It is a view.

In the first embodiment, the shape of the through-holes of the first portion 83 and the second portion 84 provided in the side surface of the hollow cylindrical shape is substantially perfect circle when viewed from the front in the through-hole direction. However, the shape of the through holes of the first portion and the second portion is not limited to perfect circles. The marker 8b may have a rectangular shape when the through holes of the first portion 83b and the second portion 84b forming the transmission portion 82b are viewed from the front.

As shown in FIG. 30 in this modified example, the first portion 83b and the second portion 84b are configured such that the rectangular shape of the through hole when viewed from the front in the direction Z, which is the through hole, has the same size. . As shown in FIGS. 36 and 37, when viewed from a direction Y that intersects a direction Z (one direction) corresponding to the through-hole direction of the through holes of the first portion 83b and the second portion 84b, the first portion 83b is , in this modified example, is configured to have the same size as the second portion 84b.

Here, information about the inclination of the medical device including the marker 8b is obtained from an angio image obtained when the marker 8b is rotated around the direction Y as the rotation axis as shown in FIGS. 32 and 33 from the front view state shown in FIG. The acquisition method will be explained. In such a case, the boundary between the first portion 83 and the second portion 84 such as points P1 and P2 in FIG. 13 described in the first embodiment cannot be confirmed in FIG. 33 and the like. However, when the shape of the transmitting portion 82b is rectangular, the rectangular shape of the transmitting portion 82b changes its dimensions according to the tilting direction. The contour shape of the transmission part can change in the dimension of the coordinate axis in the direction intersecting the axis of rotation.

In the case of FIGS. 32 and 33, it can be understood that the horizontal dimension of the rectangular shape of the transmissive portion 82b has changed and the vertical dimension has not changed compared to the angio image viewed from the front shown in FIG. . In such a case, the first portion 83b and the second portion 84b are arranged side by side in the horizontal direction, and the direction Y intersecting the horizontal direction (axial direction X) in which the dimensions change is the axis of rotation. device can be determined to be rotating.

Aside from the above, consider a case where the vertical dimension changes without changing the horizontal dimension (not shown). In this case, the first portion 83b and the second portion 84b are arranged vertically, and the medical device including the marker 8b rotates about the horizontal direction (axial direction X) that intersects the vertical direction in which the dimensions change. It can be determined that

Furthermore, as shown in FIG. 34, consider a case where both the vertical and horizontal dimensions of the rectangular shape are changed. It can be determined that the medical device including the marker 8b is rotating around both the axial direction X, which is the horizontal direction, and the direction Y, which is the vertical direction.

In this modified example, the contrast formation part 81b and the transmission part 82b are different from the first embodiment only in the shapes of the first part 83b and the second part 84b, so detailed description thereof will be omitted. Further, although the shape of the through holes of the first portion 83b and the second portion 84b is configured to be rectangular, the shape of the through holes may be polygonal other than rectangular.

<Modification 3 of the first embodiment>
FIG. 38 is a view of the guide wire W and the marker 8c according to Modification 3 viewed from the direction Y in a state in which the guidewire W and the marker 8c according to Modification 3 are arranged side by side in the direction Y intersecting the penetrating direction. . FIG. 39 is a view of the guide wire W and the marker 8c according to Modification 3 viewed from the opposite direction to FIG.

In Modified Example 2, the marker 8b, as shown in FIGS. 36 and 37, has a first It has been described that the portion 83b has the same size as the second portion 84b.

However, in addition to the above, as shown in FIGS. 38 and 39, when the marker 8c is viewed from the direction Z intersecting the penetrating direction of the through holes of the first portion 83c and the second portion 84c, the first portion 83c is It may be configured to be different in size (asymmetrical) from the second portion 84c. As shown in FIG. 38, when the guidewire W and the marker 8c are at least partially overlapped and the guidewire W is located on the front side of the marker 8c, the operator places the first portion 83c on the left side and the second portion 83c on the left side. It can be grasped in advance that the portion 84c is positioned on the right side. On the contrary, as shown in FIG. 39 , when the guide wire W and the marker 8 c overlap at least partially and the marker 8 c is on the front side of the guide wire W, the operator should place the first part 83 c on the right side and the first part 83 c on the right side. It can be grasped in advance that the second part 84c is positioned on the left side. Here, the position of the guide wire W corresponds to the second tubular body 62 and the third tubular body 63 that are the guide wire sheath, and the position of the marker 8 c corresponds to the first tubular body 61 . By thinking in this way, the operator can see that the first tubular body 61 is on the front side with respect to the second tubular body 62 and the third tubular body 63 based on the positional relationship between the first part 83c and the second part 84c in the angiographic image. It can be determined whether it is positioned or positioned on the far side. In this modified example, the contrast formation part 81c and the transmission part 82c are configured so that the shapes of the first part 83c and the second part 84c are different from those of the first embodiment. Modification 2 is a method of obtaining information about the inclination of the marker 8c in the angio image by the transmission part 82c when the marker 8c is inclined from a state viewed from the front in the through-hole direction of the through holes of the first part 83c and the second part 84c. is similar to Therefore, detailed description is omitted.

Like the medical device 1, in a medical device that captures an image inside a living body lumen using ultrasonic waves or the like, a first tubular body 61 for advancing and retracting the drive shaft 42, a second tubular body 62 for inserting the guide wire W, and The third tubular body 63 is configured so as not to be coaxial with the sheath (see FIG. 2). During a procedure using such an imaging diagnostic catheter, the operator determines which of the imaging sheath (first tubular body 61) and the guidewire sheath (second tubular body 62 and third tubular body 63) is on the angiographic image. There is a case where it is desired to grasp whether it is in the foreground.

Here, if there were no markers having different sizes for the first part and the second part as in this modified example, the operator would acquire angio images by photographing from a plurality of different directions, and the acquired a plurality of angio images. Therefore, it is necessary to grasp the positional relationship between the imaging sheath and the guidewire sheath.

On the other hand, in this modified example, as shown in FIGS. 38 and 39, the shapes of the first portion 83c and the second portion 84c in the direction Y intersecting with the penetrating direction of the through holes of the first portion 83c and the second portion 84c are configured differently. With this configuration, it is possible to determine which of the image sheath (first tubular body 61) and the guidewire sheath (second tubular body 62 and third tubular body 63) is positioned closer to the viewer in the angio image. It can be judged from the angio image. As a result, the positional relationship between the guide wire W and the imaging sensor such as the ultrasonic transducer 411 can be grasped in a shorter time.

<Modified examples 4 and 5 of the first embodiment>
FIG. 40 is a perspective view showing a marker 8d of a medical device according to modification 4 of the first embodiment. In the first embodiment, as shown in FIG. 9, the marker 8 is provided with through-holes relating to the first portion 83 and the second portion 84 as the transmission portion 82 on the hollow cylindrical side surface. However, the specific shape of the marker is not limited to a hollow cylinder as long as the marker has a contrast formation part and a transmission part whose shape changes in the angio image according to the orientation of the marker.

As for the shape of the marker 8d, as shown in FIG. 40, the contrast formation part 81d may include a solid rectangular parallelepiped, and the transparent part 82d may include through holes formed in the opposing surfaces of the solid rectangular parallelepiped. Good (modification 4). In FIG. 40, the portion formed on the front side of the rectangular parallelepiped corresponds to the first portion 83d, and the portion formed on the back side of the rectangular parallelepiped corresponds to the second portion 84d.

Note that the first portion 83d and the second portion 84d are formed by forming through holes in a solid rectangular parallelepiped, and the rest is the same as in the first embodiment, so description thereof will be omitted. Since the method of acquiring information about the tilt of the marker 8d by the transparent portion 82d when the marker 8d is tilted is the same as in the first embodiment, detailed description thereof will be omitted.

With this configuration as well, the shape and size of the transmissive portion of the marker 8d change according to the orientation of the marker 8d with respect to the imaging direction of the angiographic image, and the medical device including the marker 8d changes with respect to the imaging plane. You can grasp whether it is tilted like this.

In addition, in the first embodiment, the contrast formation part 81 is described as including a hollow cylinder, but the present invention is not limited to this. You may comprise a transmission|transmission part by. In addition, in order to make the shapes of the first part and the second part different in the shape of the solid as in the first modification of the first embodiment, a member including the shape of the first part and a member including the shape of the second part may be joined at an interface so that at least a part of the shape of the through hole communicates.

Further, although it has been explained that the rectangular parallelepiped according to Modification 4 is solid, the present invention is not limited to this, and the rectangular parallelepiped shown in FIG. You may

Further, the marker 8d according to Modified Example 4 shown in FIG. 40 is a rectangular parallelepiped as described above, and is configured so that the dimension in the depth direction is not smaller than the dimension in the directions other than the depth direction. However, if the contrast formation part and the transmission part are provided as described above, the marker is such that the dimension of the contrast formation part 81e in the direction Z (thickness direction) is different from the direction Z, like the marker 8e shown in FIG. It may be configured to include thin plates that are extremely small compared to the directional dimensions (Variation 5). The transmitting portion 82e, the first portion 83e, and the second portion 84e are formed by providing through holes in the thin plate of the contrast forming portion 81e. .

42 and 43, the shape and size of the first portion 83e and the second portion 84e that constitute the transparent portion 82e can be adjusted according to the orientation of the medical device including the marker 8e. changes. As in the first embodiment and the like, the operator can acquire information about the tilt of the medical device from the shape deformation of the transmissive portion 82e that accompanies the tilt.

The present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical concept of the present invention. It has been described above that the transmitting portion 82 of the marker 8 has a through hole provided in the hollow cylindrical shape (first member) that constitutes the contrast forming portion 81 .

However, as described above, the specific configuration of the transparent portion is not limited to the through-hole as long as the shape of the transparent portion is displayed differently depending on the orientation of the marker in the angio image. In addition to the above, the transmission part is provided in a first member that can display a shadow in an X-ray contrast image, such as a hollow cylindrical shape, and can transmit X-rays. It may be configured to include a second member extending in Z.

The second member may comprise, by way of example, a highly permeable solid material such as a polymer such as polyethylene, glass, and/or a low density mesh. Note that the transmittance of the second member does not necessarily have to be 0%, as long as the transmittance (transmittance) of the second member related to the transmitting part to X-rays and the like is higher than that of the contrast forming part. With this configuration as well, the shape of the transmissive portion changes according to the orientation of the marker, so that the operator can acquire three-dimensional information such as the inclination of the medical device.

In the above, the through holes of the first portion and the second portion forming the transmission portion intersect with the axial direction X, and the first tubular body 61, the second tubular body 62, and the third tubular body 63 is along the direction Z intersecting with the direction Y in which . However, if the transmitting portion of the marker does not overlap the guide wire W when the medical device is tilted, the penetrating direction of the through-holes of the first and second portions constituting the transmitting portion or the extending direction of the second member is not limited to along the Z direction. In addition to the above, the penetrating direction of the through hole or the extending direction of the second member is configured to be different from the direction Y and the direction Z on the YZ plane that intersects (perpendicularly) with the axial direction X as shown in FIG. You may

Also, in the first embodiment, the marker 8 is provided so as to be embedded in the reinforcing tube 23 provided at the distal end of the first tubular body 61 . However, the marker may be embedded in a tubular member such as the first tubular body 61 in a state where the reinforcing tube 23 is not provided.

In addition, it has been described above that the medical device is an imaging catheter such as IVUS. However, the medical device is not limited to an IVUS catheter as long as it has a sheath through which a guidewire is passed and can obtain information in the depth direction intersecting the imaging direction of the angiographic image from the markers described above. In addition to the above, the medical device may be applied to a medical device that displays an image of a living body lumen by OFDI (Optical Frequency Domain Imaging) or OCT (Optical Coherence Tomography). Also, the medical device containing the markers described above may be a balloon catheter, a stent delivery system, or the like.

1 medical device,
61 first tubular body (tubular member, first member, imaging sheath),
62 second tubular body (guide wire sheath),
63 third tubular body (guide wire sheath),
8, 8a, 8b, 8c, 8d, 8e markers,
81, 81a, 81b, 81c, 81d, 81e contrast forming part (first member),
82, 82a, 82b, 82c, 82d, 82e transmitting portion (second member),
83, 83a, 83b, 83c, 83d, 83e first site,
84, 84a, 84b, 84c, 84d, 84e Second site.

Claims (8)

a tubular member that can be inserted into a biological lumen;
a guidewire sheath provided adjacent to the tubular member and including a guidewire lumen through which a guidewire can be inserted;
a marker provided integrally with the tubular member and comprising: a contrast forming part having X-ray contrastability; , has
The medical device according to claim 1, wherein the transmissive portion is displayed in a different shape depending on the orientation of the marker in the X-ray contrast image. The transmissive portion is formed on a first portion formed on the outer surface of the marker, and on the outer surface of the marker, a portion different from the first portion and formed to communicate with the first portion when viewed from one direction. 2. The medical device of claim 1, comprising a second portion that is . The medical device according to claim 2, wherein the first portion has the same shape as the second portion when viewed from the one direction. The medical device according to claim 2, wherein the first portion has a shape different from that of the second portion when viewed from the one direction. The medical device according to claim 2, wherein the first portion has a shape different from that of the second portion when viewed from a direction intersecting the one direction. 2. The medical device according to claim 1, wherein the contrast formation section includes a first member capable of displaying a shadow in an X-ray contrast image, and the transmission section includes a through hole formed in the first member. The contrast formation unit comprises a first member capable of displaying a shadow in an X-ray contrast image,
2. The medical device according to claim 1, wherein the transmitting portion includes a second member formed in the first member so as to communicate in one direction and capable of transmitting X-rays. The tubular member comprises an imaging sheath having an imaging lumen into which a drive shaft capable of rotational and axial movement is inserted so as to move back and forth,
The medical device according to any one of claims 1 to 7, wherein the marker is embedded in the distal end portion of the imaging sheath.

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