JP6826847B2 - Medical device - Google Patents

Description

The present invention relates to medical devices.

Conventionally, in order to acquire a diagnostic image for diagnosing a lesion when percutaneously treating a lesion generated in the biological lumen, a tomographic image in the biological lumen is used by using ultrasonic waves or light. Medical devices are used to obtain.

The following Patent Document 1 includes a drive shaft provided with an imaging unit capable of acquiring image information at the tip, a lumen through which the drive shaft is inserted, and a shaft portion inserted into a biological lumen and a shaft portion. A medical device having an operation unit connected to a proximal end side and performing a predetermined operation by an operator is disclosed.

Special Table No. 10-500584

The medical device is driven by connecting an operation unit to an external drive device. Therefore, the arrangement of the external drive device may be restricted depending on the position and orientation in which the medical device is operated. Due to the limitation of the arrangement of the external drive device, when the operator operates and works on the medical device, it may not be possible to perform a smooth work.

Further, when the operator moves the shaft portion toward the proximal end side in order to remove the medical device from the lumen of the living body, if the external drive device is fixed, the shaft portion and the external drive device are separated from each other. There is a risk of damage due to a load applied to the arranged operation unit. For this reason, the surgeon had to collaborate with other surgeons to move the medical device and the external drive device at the same time. As a result, it took time and effort to remove the material.

The present invention has been made to solve the above-mentioned problems, and an object of the present invention is to provide a medical device capable of improving the workability of an operator.

A medical device that achieves the above object is a medical device that is inserted into a living lumen to acquire an image. The medical device includes an image sheath having an image lumen through which a drive shaft can be inserted, a guide wire sheath having a guide wire lumen arranged side by side with the image lumen and an insertable guide wire, and the same. An image pickup unit fixed to the tip of the drive shaft and capable of acquiring image information, an operation unit connected to an external drive device while holding the base end portion of the drive shaft, an image sheath and the guide wire. It has a hub portion connected to the base end of the sheath, a lumen that communicates with the image lumen, and a tube that connects the operation portion and the hub portion. The tube has curvable flexibility. The operation unit holds the outer pipe connected to the base end of the tube and the drive shaft in the inner cavity, and moves relative to the outer pipe in the outer pipe as the drive shaft moves. It has an inner tube that is configured as possible. The outer tube is formed in a substantially linear shape. The tube has higher flexibility than the outer tube.

According to the medical device configured as described above, the distance and the directionality between the operation portion and the hub portion can be flexibly adjusted by bending or extending the tube. As a result, the position and orientation of the external drive device connected to the medical device can be flexibly adjusted. Therefore, the workability of the operator can be improved.

It is a top view which shows the medical device which concerns on embodiment. It is sectional drawing along the axial direction which shows the tip part of the medical device which concerns on embodiment. It is a top view which shows the hub of the medical device which concerns on embodiment. It is a top view which shows the external drive device. It is a top view which shows the medical device when the oscillator unit is pulled back. It is a flowchart which shows the procedure using the medical device which concerns on embodiment. (A) is a diagram schematically showing a state of performing diagnosis using a medical device according to a inverse proportion, and (B) and (C) are a diagram showing a state of performing diagnosis using a medical device according to an embodiment. It is a diagram schematically showing the state of performing. (A) is an enlarged plan view showing a part of the medical device according to the modified example, and (B) is a perspective view showing a length adjusting portion.

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

As shown in FIGS. 1 and 2, the medical device 1 is an ultrasonic catheter that contains an imaging core 4 for acquiring a diagnostic image by ultrasonic waves and is inserted into a living lumen. The medical device 1 is connected to an external drive device 7 (see FIG. 4) that holds the medical device 1 and drives the imaging core 4, and is used for diagnosing the inside of a biological lumen such as a blood vessel. To.

In the present specification, the side to be inserted into the living lumen is referred to as "tip" or "tip side", and the hand side for operating the medical device 1 is referred to as "base end" or "base end side". Further, a portion indicating a certain range including the tip and its peripheral portion is referred to as a "tip portion", and a portion indicating a certain range including the proximal end and its peripheral portion is referred to as a "base end portion". Further, the direction in which the image lumen 25 through which the imaging core 4 is inserted extends is referred to as an "axial direction".

As shown in FIG. 1, the medical device 1 includes a long shaft portion 2 inserted into the biological lumen, an operation portion 3 in which the operator performs a predetermined operation, and a tissue in the biological lumen. A tube 8 that connects the imaging core 4 that transmits and receives ultrasonic waves toward the hub, the hub portion 5 that inserts the imaging core 4 and is arranged on the proximal end side of the shaft portion 2, and the operation portion 3 and the hub portion 5. And have.

The shaft portion 2 includes a shaft tip portion 21 and a shaft main body portion 22 arranged on the base end side of the shaft tip portion 21.

A guide wire lumen 26 into which the guide wire W is inserted is formed in the shaft tip portion 21.

The shaft main body 22 is formed with an image lumen 25 into which the imaging core 4 is inserted and a guide wire lumen 26 into which the guide wire W is inserted. The guide wire lumens 26 are arranged side by side substantially parallel to the image lumen 25. The medical device 1 according to the present embodiment is a so-called over-the-wire (OTW) type catheter in which a guide wire lumen 26 is formed from a shaft tip portion 21 to a shaft main body portion 22. The cross-sectional shapes of the image lumen 25 and the guide wire lumen 26 are not particularly limited, but can be formed in a substantially circular shape, for example.

The guide wire W used in the medical device 1 of the present embodiment is a long body having flexibility and having a substantially constant outer diameter over the entire length. The cross-sectional shape of the guide wire W is not particularly limited, but can be formed, for example, in a substantially circular shape.

The guide wire W is configured to be observable by an angio image obtained by photographing the biological lumen from outside the body by X-ray photography. The constituent material of the guide wire W is not particularly limited as long as it can be observed from the angio image, but for example, a metal such as stainless steel, spring steel, titanium, tungsten, tantalum, or a superelastic alloy such as a nickel-titanium alloy is used. be able to.

The shaft portion 2 is formed by heat-sealing (or adhering) the image sheath 61 on which the image lumen 25 is formed and the guide wire sheath 62 on which the guide wire lumen 26 is formed.

As shown in FIG. 2, the image sheath 61 has a tip opening 61a, and the guide wire sheath 62 has a tip opening 62a. A reinforcing tube 23 for firmly joining and supporting the guide wire sheath 62 is provided at the tip of the image sheath 61. The reinforcing tube 23 is a tube body in which a communication hole 24 that communicates with the tip opening 61a is formed. The reinforcing tube 23 is formed by heat-sealing (or adhering) to the image sheath 61 using a material having a relatively high rigidity.

As shown in FIG. 3, the shaft main body 22 is branched from the shaft intermediate portion 221 formed by arranging the image lumen 25 and the guide wire lumen 26 on the tip side toward the proximal end direction. It is provided with a first shaft base end portion 222 and a second shaft base end portion 223 extending so as to extend. An image lumen 25 is formed inside the first shaft base end portion 222, and a guide wire lumen 26 is formed inside the second shaft base end portion 223. The outer diameter and inner diameter of the shaft main body 22 may differ depending on the position in the axial direction. For example, by tapering the outer diameter and inner diameter from the base end side to the tip end side to prevent extreme changes in physical properties, high pushability and passability are achieved while suppressing the occurrence of kink. can do.

The length of the shaft portion 2 along the axial direction is not particularly limited, but may be, for example, 600 mm to 2000 mm. When the medical device 1 is used for a lower limb procedure, especially for femoral artery puncture, the axial length of the shaft portion 2 is shorter than that of the medical device used for a cardiac procedure, for example. , 600 mm to 1200 mm.

The shaft portion 2 is formed of a flexible material, and the material is not particularly limited. For example, styrene-based, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, polyimide-based, polybutadiene-based, transpolyisoprene. Examples thereof include various thermoplastic elastomers such as system, fluororubber type, and chlorinated polyethylene type, and one or a combination of two or more of these (polymer alloy, polymer blend, laminate, etc.) can be applied. The image sheath 61 on which the image lumen 25 is formed is preferably made of a material having high ultrasonic wave transmission.

As shown in FIG. 1, the operation unit 3 is configured such that the tip portion is connected to the tube 8 and the base end portion can be connected to an external drive device 7 (see FIG. 4) for operating the imaging core 4. There is. The operation unit 3 includes an outer pipe 31 connected to the tube 8, an inner pipe 32 arranged inside the outer pipe 31, a unit connector 33 connected to the base end portion of the outer pipe 31, and the inner pipe 32. It includes an operation base end portion 34 connected to the base end portion. The outer pipe 31 and the inner pipe 32 have a double pipe structure for performing a pullback operation.

The tip of the outer tube 31 is connected to the tube 8, and the base end is connected to the unit connector 33. The outer tube 31 has kink resistance and is formed in a substantially linear shape. As a result, the outer tube 31 secures a path for the inner tube 32 to move in the axial direction in the inner cavity.

A kink-resistant protector 311 is provided at the connecting portion between the outer tube 31 and the tube 8 to suppress kinking at the connecting portion between the tube 8 and the outer tube 31.

The inner tube 32 is arranged in the lumen of the outer tube 31 and is configured to be movable back and forth in the axial direction relative to the outer tube 31. The lumen of the inner tube 32 communicates with the image lumen 25, and the drive shaft 42 of the imaging core 4 is inserted therethrough. A stopper 321 is arranged at the tip of the inner pipe 32. The stopper 321 is configured to be engageable with the inner wall of the unit connector 33. The base end portion of the inner pipe 32 is connected to the operation base end portion 34. By operating the operation base end portion 34, the operator can move the drive shaft 42 and move the inner tube 32 in the axial direction relative to the outer tube 31 as the drive shaft 42 moves. ..

When the inner pipe 32 is pushed most toward the tip end side, the end portion of the inner pipe 32 moves inside the outer pipe 31 and reaches the vicinity of the tip end of the outer pipe 31 as shown in FIG. In this state, the oscillator unit (corresponding to the imaging unit) 41 of the imaging core 4 is located near the tip of the image lumen 25, as shown in FIG.

Further, when the inner pipe 32 is pulled to the most proximal side by the pullback operation, as shown in FIG. 5, the stopper 321 formed at the tip of the inner pipe 32 is caught on the inner wall of the unit connector 33, and the base of the inner pipe 32. Part of the edge side is exposed. In this state, the oscillator unit 41 moves relative to the shaft portion 2 toward the proximal end side. In this way, the oscillator unit 41 can move along the axial direction while rotating inside the image lumen 25 in order to acquire a tomographic image in the biological lumen.

The unit connector 33 is inserted so that the base end portion of the outer tube 31 fits inside. The unit connector 33 is configured to be connectable to a holding portion 73 (see FIG. 4) of the external drive device 7.

The operating base end 34 holds the drive shaft 42. The operating base end 34 has a port 341, a joint 342, a hub-side connector 343 connected to the base end of the drive shaft 42, and a kink-resistant protector 344.

Port 341 communicates with the image lumen 25. The port 341 is connected to a priming syringe or a Y connector so that a fluid such as a priming liquid can be supplied to the image lumen 25.

The joint 342 has an opening on the base end side, and the hub side connector 343 is arranged inside. The hub-side connector 343 is configured to be connectable from the base end side of the joint 342 to the drive-side connector 711 (see FIG. 4) of the external drive device 7. By connecting the hub-side connector 343 and the drive-side connector 711, the external drive device 7 and the hub-side connector 343 are mechanically and electrically connected.

One end of the signal line 43 (see FIG. 2) is connected to the hub-side connector 343. As shown in FIG. 2, the signal line 43 passes through the drive shaft 42 and the other end is connected to the oscillator unit 41. Ultrasonic waves are emitted from the oscillator unit 41 by a signal transmitted from the external drive device 7 to the oscillator unit 41 via the drive side connector 711, the hub side connector 343, and the signal line 43. Further, the signal detected by the oscillator unit 41 by receiving the ultrasonic waves is transmitted to the external drive device 7 via the signal line 43, the hub-side connector 343, and the drive-side connector 711.

The kink-resistant protector 344 is arranged around the inner pipe 32 and the operation base end portion 34 to suppress the kink of the inner pipe 32.

As shown in FIG. 2, the imaging core 4 is arranged in the image lumen 25 and is configured to be movable back and forth in the axial direction relative to the shaft portion 2. The imaging core 4 includes an oscillator unit 41 capable of transmitting and receiving ultrasonic waves from the inside of a living cavity toward a living tissue to acquire image information, a drive shaft 42 to which the oscillator unit 41 is attached to a tip and rotated. have. The oscillator unit 41 is composed of an ultrasonic oscillator 411 that transmits and receives ultrasonic waves, and a housing 412 that houses the ultrasonic oscillator 411.

The oscillator unit 41 is configured to be observable by an angio image. The constituent material of the housing 412 is not particularly limited, but a metal such as gold, platinum, platinum alloy, tungsten alloy, or barium sulfate, bismuth oxide, tungsten, etc., so as to function as an X-ray contrast medium. It preferably contains an X-ray contrast material. Further, an X-ray contrast marker may be separately provided in the vicinity of the housing 412.

The drive shaft 42 is flexible and has a characteristic that the rotational power generated by the external drive device 7 can be transmitted to the oscillator unit 41. The drive shaft 42 is composed of, for example, a multi-layer coil-like tube such as a three-layer coil in which right and left and winding directions are alternated. When the drive shaft 42 transmits the power of rotation, the oscillator unit 41 rotates, and the lesion portion in the living lumen such as a blood vessel can be observed in the circumferential direction. Further, in the drive shaft 42, a signal line 43 for transmitting a signal detected by the vibrator unit 41 to the operation unit 3 is passed through the inside.

As shown in FIG. 3, the hub portion 5 has a first hub portion 51 airtightly connected to the first shaft base end portion 222 and a second hub portion 52 airtightly connected to the second shaft base end portion 223. A hub body portion 53 connected to the first hub portion 51 and the second hub portion 52, and a kink-resistant protector 54 are provided. The first hub portion 51, the second hub portion 52, and the hub main body portion 53 are integrally formed.

As shown in FIGS. 1 and 3, the first hub portion 51 is heat-sealed or heat-sealed by connecting the tip end portion of the tube 8 from the proximal end side and inserting the first shaft proximal end portion 222 from the distal end side. It is glued and airtightly connected. Therefore, the physiological saline solution injected into the tube 8 through the port 341 of the operation base end portion 34 can be moved to the image lumen 25 through the first hub portion 51.

The second hub portion 52 is airtightly connected by inserting the second shaft base end portion 223 from the tip end side and heat-sealing or adhering. The second hub portion 52 communicates with the guide wire lumen 26, and the guide wire W can pass through.

As shown in FIG. 3, the hub main body 53 covers the outer peripheral surfaces of the first shaft base end 222 and the second shaft base end 223 connected to the first hub 51 and the second hub 52, respectively. Is formed in.

Inside the hub main body 53, a portion that branches from the shaft intermediate portion 221 to the first shaft base end portion 222 and the second shaft base end portion 223 is arranged in the direction of the base end. Therefore, the first shaft base end portion 222 and the second shaft base end portion 223, which are less rigid than the shaft intermediate portion 221 because the image sheath 61 and the guide wire sheath 62 are not joined, are the hub main body portion 53. It is not located outside the, and can demonstrate high pushability.

As shown in FIG. 1, the kink-resistant protector 54 surrounds the tip of the hub body 53 and the shaft body 22 led out from the hub body 53 toward the tip, and suppresses the kink of the shaft body 22.

The constituent materials of the first hub portion 51, the second hub portion 52, the hub main body portion 53, the outer tube 31, the inner tube 32, the unit connector 33, and the operation base end portion 34 are formed of a material harder than the tube 8. The limitation is not particularly limited, and for example, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylic nitrile-butadiene-styrene copolymer, polyethylene terephthalate. , Polyesters such as polyethylene naphthalate, butadiene-styrene copolymers, and various resins such as polyamides (eg, nylon 6, nylon 6/6, nylon 6/10, nylon 12).

The configuration of the hub portion 5 is not limited to that described above, and for example, a split mold that covers the peripheral surfaces of the base end portion of the shaft intermediate portion 221, the first shaft base end portion 222, and the second shaft base end portion 223. It may be configured by a casing of the structure.

The tip of the tube 8 is connected to the first shaft base end 222 via the first hub 51, and the base end is connected to the outer tube 31. The tube 8 includes a lumen 81 that communicates with the image lumen 25, and a drive shaft 42 is inserted in the lumen 81.

The tube 8 has curvable flexibility. As a result, the tube 8 is configured so that the distance between the outer tube 31 of the operation unit 3 and the hub unit 5 can be adjusted. In this embodiment, the tube 8 is configured to be more flexible than the outer tube 31. Here, "curvable" means that the tube 8 can be deformed in a direction intersecting with a direction extending linearly.

The tube 8 can be formed of polyetheretherketone (PEEK) or the same material as the shaft portion 2 described above.

The length of the tube 8 along the axial direction can be appropriately selected depending on the length of the shaft portion 2 and the application of the medical device 1, but when the medical device 1 is used for a lower limb procedure, for example, 10 cm to 100 cm. Can be. The inner diameter of the tube 8 can be, for example, 0.6 mm to 1.0 mm, and the wall thickness can be about 0.5 mm.

As shown in FIG. 4, the medical device 1 described above is connected to and driven by an external drive device 7. The external drive device 7 includes a drive unit 71 that incorporates an external drive source such as a motor on the base 75 to rotationally drive the drive shaft 42, and a moving means 72 that grips the drive unit 71 and moves it in the axial direction. A holding portion 73 for holding the unit connector 33 of the medical device 1 in a fixed position, and a groove rail 76 extending in the axial direction are provided. The external drive device 7 is connected to a control unit 79 that controls the drive unit 71 and the moving means 72, and the image obtained by the oscillator unit 41 is displayed on the display unit 78 connected to the control unit 79. ..

The drive unit 71 has a drive-side connector 711 to which the hub-side connector 343 of the medical device 1 can be connected, and a joint connection unit 712 to which the joint 342 of the medical device 1 can be connected. By connecting the joint connecting portion 712 to the joint 342, it is possible to transmit and receive a signal to and from the oscillator unit 41, and at the same time, it is possible to rotate the drive shaft 42.

The moving means 72 is provided with a motor or the like, and is configured to be able to move the drive unit 71 forward and backward in the axial direction along the groove rail 76 while holding the drive unit 71.

In the ultrasonic scanning in the medical device 1, as shown in FIGS. 4 and 5, the rotational movement of the motor in the drive unit 71 is transmitted to the drive shaft 42 while moving the moving means 72 in the axial direction. , The housing 412 fixed to the tip of the drive shaft 42 is rotated. As a result, the ultrasonic vibrator 411 provided in the housing 412 rotates while moving in the axial direction, and the ultrasonic waves transmitted and received by the ultrasonic vibrator 411 can be scanned in the substantially radial direction. As a result, a 360 ° tomographic image of the surrounding tissue in the biological lumen along the axial direction can be obtained by scanning to an arbitrary position.

Next, with reference to FIGS. 6 and 7 (A) to 7 (C), an operation when observing a living tissue from inside a living lumen such as a blood vessel will be described using the medical device 1 according to the embodiment. To do. In the following description, a lesion formed in a blood vessel of the lower limb of patient P will be described as an observation site.

First, as step S1, a priming process is performed in which the inside of the medical device 1 is filled with a physiological saline solution. By performing the priming process, ultrasonic waves can be transmitted from the ultrasonic vibrator 411, and air in the medical device 1 is removed to prevent air from entering the blood vessels.

In order to perform the priming of the image lumen 25, as shown in FIG. 5, the operation base end portion 34 is pulled most toward the base end side from the unit connector 33, that is, the inner tube 32 is most pulled out from the outer tube 31. Put it in the state. Then, the physiological saline solution is injected through an instrument consisting of a tube (not shown) and a three-way stopcock connected to the port 341 of the operation base end 34, for example, using a syringe or the like. The injected physiological saline solution is filled into the image lumen 25 from the operation base end portion 34 through the first hub portion 51, and the physiological saline solution is discharged from the tip opening 61a (see FIG. 2). As a result, the filling of the physiological saline solution is confirmed, and the priming process in the image lumen 25 is completed.

In order to perform priming of the guide wire lumen 26, a physiological saline solution is injected through an instrument consisting of a tube (not shown) and a three-way stopcock connected to the second hub portion 52, for example, using a syringe or the like. The injected physiological saline solution is filled in the guide wire lumen 26 through the second hub portion 52, and the physiological saline solution is discharged from the tip opening 62a (see FIG. 2). As a result, the filling of the physiological saline solution is confirmed, and the priming process in the guide wire lumen 26 is completed.

Next, as step S2, as shown in FIG. 4, the medical device 1 is connected to an external drive device 7 covered with a sterilized polyethylene bag or the like (not shown). That is, the joint 342 of the operation base end portion 34 of the medical device 1 is connected to the joint connection portion 712 of the drive unit 71. As a result, signals can be transmitted and received between the oscillator 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 33 is fitted to the holding portion 73, the connection is completed.

If the operation unit 3 is directly connected to the hub unit 5 as shown in FIG. 7A, the position and orientation in which the external drive device 7 is arranged are limited. Therefore, when the operator H1 is operating the guide wire W, it is necessary for another operator H2 to hold the external drive device 7 and fix the position and orientation.

Further, in the case of the operation unit 3 including the outer pipe 31 and the inner pipe 32 for performing the pullback operation, it is necessary to secure the inner space of the outer pipe 31 in order to smoothly move the inner pipe 32. Therefore, the outer tube 31 has kink resistance and is formed in a substantially linear shape. As a result, the position and orientation in which the external drive device 7 is arranged are further limited.

Further, in the case of an over-the-wire type catheter, the operator H1 operates the guide wire W on the proximal end side of the medical device 1. Therefore, the distance between the operator H1 and the other operator H2 holding the external drive device 7 becomes short. As a result, the operator H1 and another operator H2 may interfere with each other, resulting in reduced workability.

In the medical device 1 according to the present embodiment, the tube 8 is bent (see FIG. 1) or stretched (see FIG. 7B) to allow the tube 8 to be between the operation unit 3 and the hub unit 5. The distance and direction can be adjusted flexibly. For example, as shown in FIG. 7B, the distance between the operation portion 3 and the hub portion 5 can be increased by extending the curved portion of the tube 8. In this way, since the distance between the operator H1 and the other operator H2 can be adjusted, the work can be smoothly performed without interfering with each other during the work.

Further, for example, as shown in FIG. 7C, the directionality of the operation portion 3 and the hub portion 5 can be flexibly changed by greatly bending the tube 8. As a result, the external drive device 7 can be fixed at an arbitrary position. Therefore, it is not necessary for another operator H2 to hold the external drive device 7, so that the work can be performed more efficiently.

Next, as step S3, the guide wire W is inserted into the blood vessel via the guiding sheath that is percutaneously inserted into the blood vessel by the Seldinger method. After that, the base end portion of the guide wire W is inserted into the guide wire lumen 26 via the tip opening 62a.

After the guide wire W is led out from the second hub portion 52 to the proximal end side, the shaft portion 2 of the medical device 1 is pushed along the guide wire W, and the tip portion of the shaft portion 2 is more than the lesion portion to be observed. Place it on the back side (tip side). At this time, since the first hub portion 51 and the second hub portion 52 face in different directions, the guide wire W can be operated without being interfered with by the operation unit 3 or the external drive device 7.

Further, since the guide wire lumen 26 is opened at the second hub portion 52, it is easy to replace the guide wire W. Therefore, by properly using the guide wire W having an arbitrary load and shape, it is possible to efficiently reach the medical device 1 to the deep part of the complicated portion. Further, a contrast medium or a drug can be supplied to the guide wire lumen 26 via the second hub portion 52 and discharged into the living body from the tip opening 62a.

In this state, while holding the shaft portion 2 so as not to move, the drive portion 71 is moved toward the tip side along the groove rail 76 on the base 75 (see FIG. 4) to move the operation base end portion 34. The inner tube 32 is pushed most into the outer tube 31 by moving it to the tip side. As a result, as shown in FIG. 1, the oscillator unit 41 moves to the tip end side of the image lumen 25.

Next, as step S4, an X-ray image is taken from outside the body at the position (lesion portion) where the vibrator unit 41 is arranged to acquire an angio image. By checking the angio image, the position and posture of the tip of the medical device 1 can be grasped.

Next, in step S5, the drive shaft 42 is pulled back while being rotated by the drive unit 71, so that the ultrasonic oscillator 411 is moved along the axial direction from the affected portion toward the proximal end side while performing radial scanning. As a result, a 360 ° tomographic image of the surrounding tissue in the axial direction in the blood vessel including the affected area can be obtained by scanning to an arbitrary position.

By grasping the positional relationship between the guide wire W and the oscillator unit 41 from both the tomographic image and the angio image and matching the directions of the tomographic image and the angio image, the position of the lesion visible in the tomographic image can be efficiently located. The guide wire W can be advanced.

Next, as step S6, the shaft portion 2 of the medical device 1 is removed from the blood vessel while leaving the guide wire W in the blood vessel. The medical device 1 is pulled toward the proximal end along the guide wire W to remove the medical device 1 from the guide wire W.

As shown in FIG. 7A, when the operation unit 3 is directly connected to the hub unit 5, the shaft unit 2 is set to the base end side with the external drive device 7 fixed. If pulled, the operation unit 3 may be damaged. Therefore, the operator H1 for removing the shaft portion 2 needs to move the shaft portion 2 and the external drive device 7 at the same time in cooperation with another operator H2 holding the external drive device 7. As a result, it takes time and effort to remove the material.

In the medical device 1 according to the present embodiment, when the shaft portion 2 is removed from the blood vessel, as shown in FIG. 1, the tube 8 is curved to shorten the distance between the operation portion 3 and the hub portion 5. can do. As a result, the operator H1 can remove the shaft portion 2 from the blood vessel while the external drive device 7 is fixed while preventing the operation portion 3 from being damaged. Therefore, the operator H1 can smoothly perform the removal work.

After the medical device 1 is removed from the blood vessel, a replacement operation can be performed in which another medical device is inserted into the blood vessel along the guide wire W instead of the medical device 1.

The timing of bending or stretching the tube 8 is not limited to that described above, and the tube 8 can be bent or stretched at a desired timing by the operator H1 as needed.

As described above, the treatment method using the medical device 1 according to the present embodiment is arranged between the shaft portion 2 inserted into the biological lumen and the operation portion 3 connected to the external drive device 7. Medical treatment including diagnosis or treatment is performed while adjusting the distance between the shaft portion 2 and the operation portion 3 by bending or extending the tube 8.

Further, the medical practice includes connecting the external drive device 7 to the medical device 1, inserting the shaft portion 2 into the biological lumen, acquiring a tomographic image of the biological lumen, and the shaft portion 2. Includes at least one of removals from the living lumen.

Further, in the medical practice, after the external drive device 7 is connected to the medical device 1, the curved portion of the tube 8 is extended to increase the distance between the shaft portion 2 and the operation portion 3. This includes the work of arranging the external drive device 7 at a predetermined position.

Further, the medical practice includes an operation of bending the tube 8 to shorten the distance between the shaft portion 2 and the operation portion 3 when the shaft portion 2 is removed from the living lumen.

As described above, the medical device 1 according to the present embodiment is arranged side by side with the image sheath 61 having the image lumen 25 through which the drive shaft 42 can be inserted and the image lumen 25, and the guide wire W is inserted. A guide wire sheath 62 provided with a possible guide wire lumen 26, a vibrator unit (imaging unit) 41 fixed to the tip of the drive shaft 42 and capable of acquiring image information, and a base end portion of the drive shaft 42 were held. In this state, the operation unit 3 connected to the external drive device 7, the hub unit 5 connected to the base ends of the image sheath 61 and the guide wire sheath 62, and the lumen 81 communicating with the image lumen 25 are provided. It has a tube 8 for connecting the operation unit 3 and the hub unit 5. The tube 8 has curvable flexibility.

According to the medical device 1, the distance and the directionality between the hub portion 5 and the operation portion 3 can be flexibly adjusted by bending or extending the tube 8. As a result, the position and orientation of the external drive device 7 connected to the medical device 1 can be flexibly adjusted. Therefore, the operator H1 can adjust the distance from the other operator H2 that holds the external drive device 7, and can fix the external drive device 7 at an arbitrary position. Further, it is possible to prevent the operation unit 3 from being damaged when the medical device 1 is removed while the external drive device 7 is fixed. Thereby, the workability of the operator can be improved.

Further, the operation unit 3 holds the outer tube 31 connected to the base end of the tube 8 and the drive shaft 42 in the inner cavity, and the outer tube 31 is inside the outer tube 31 as the drive shaft 42 moves. It has an inner tube 32 configured to be relatively movable along the axial direction. The tube 8 has higher flexibility than the outer tube 31. The outer pipe 31 has kink resistance, and can prevent the outer pipe 31 from kinking during the pullback operation, so that the inner pipe 32 can be smoothly moved. Further, by bending or extending the tube 8, the distance and the directionality between the hub portion 5 and the outer tube 31 can be flexibly adjusted. As a result, the surgeon can smoothly perform the pullback operation and can flexibly adjust the position and orientation of the external drive device 7 connected to the medical device 1.

(Modification example)
A medical device according to a modified example will be described with reference to FIGS. 8A and 8B. The medical device differs from the above-described embodiment in that it further includes a length adjusting unit 9 for adjusting the length of the tube 8. The parts having the same functions as those in the above-described embodiment are designated by the same reference numerals, and the description thereof will be omitted.

As shown in FIG. 8A, the length adjusting portion 9 is provided in the middle of the tube 8. As shown in FIG. 8B, the length adjusting unit 9 switches between a holding unit 91 that holds at least a part of the tube 8 in a curved state and a state in which the tube 8 is held and a state in which the holding is released. It has a rotary lever (corresponding to a switching portion) 92.

The holding portion 91 has a rotating body 911 and a housing 912. The holding portion 91 holds the tube 8 wound around the rotating body 911. The housing 912 houses the rotating body 911 and the wound tube 8.

The rotary lever 92 has a rotary shaft (not shown) coaxial with the rotating body 911, and is provided on the outer surface of the housing 912. The operator can wind the tube 8 around the rotating body 911 by operating the rotating lever 92 to rotate the rotating body 911. Further, the operator can unwind the wound state of the tube 8 by operating the rotary lever 92 to rotate the rotating body 911 in the opposite direction. As a result, the length of the tube 8 can be easily adjusted by a simple operation.

As described above, the medical device according to the modified example has a holding portion 91 that holds the tube 8 in a curved state, and a rotary lever (switching portion) 92 that switches between a state in which the tube 8 is held and a state in which the holding is released. And have. Thereby, the distance between the operation unit 3 and the hub unit 5 can be easily adjusted. Therefore, the workability of the operator can be further improved.

Although the medical device according to the present invention has been described above through the embodiments and modifications, the present invention is not limited to each of the described configurations, and may be appropriately modified based on the description of the scope of claims. It is possible.

For example, in the above embodiment, a catheter for image diagnosis used in an intravascular ultrasonic diagnostic method (IVUS: Intra Vascal Ultra Sound) for obtaining a diagnostic image for diagnosing a diseased part or the like in a living body according to the present invention. Although the case of applying to the above has been described, it is also possible to apply to an image diagnostic catheter that acquires an image using light such as optical coherence tomography (OCT), and intravascular ultrasound diagnosis. It can also be applied to a hybrid type (dual type) diagnostic imaging catheter or the like that can be used for both the method and the optical coherence tomography method.

Further, the medical device is not limited to a configuration in which a pullback operation is performed to move the drive shaft to the proximal end side in the axial direction, and a configuration in which the pullback operation is not performed may be performed. In this case, the operating unit does not have a double tube structure consisting of an outer tube and an inner tube, and the drive shaft is axially fixed at an arbitrary position of the image lumen.

1 Medical device,
2 Shaft part,
21 Shaft tip,
22 Shaft body,
25 Lumens for images,
26 Guide wire lumen,
3 Operation unit,
4 Imaging core,
41 Oscillator unit (imaging unit),
42 drive shaft,
5 Hub part,
51 1st hub,
52 2nd hub,
61 Image sheath,
62 Guide wire sheath,
7 External drive device,
8 tubes,
81 lumens,
9 Length adjustment part,
91 holding part,
92 Rotating lever (switching part),
W guide wire.

Claims (2)

A medical device that is inserted into the lumen of a living body to acquire an image.
An image sheath with an image lumen through which the drive shaft can be inserted,
A guide wire sheath arranged side by side with the image lumen and provided with a guide wire lumen through which a guide wire can be inserted,
An imaging unit fixed to the tip of the drive shaft and capable of acquiring image information,
With the operation unit connected to the external drive device while holding the base end of the drive shaft,
A hub portion connected to the base end of the image sheath and the guide wire sheath, and
It has a lumen that communicates with the image lumen, and has a tube that connects the operation unit and the hub unit.
The tube is to have a bendable flexible,
The operation unit holds the outer pipe connected to the base end of the tube and the drive shaft in the inner cavity, and moves relative to the outer pipe in the outer pipe as the drive shaft moves. With an inner tube that is configured to be possible,
The outer tube is formed in a substantially linear shape.
The tube is a medical device having higher flexibility than the outer tube . Having a holding portion for holding in a state of being curved said tube, and a switching unit for switching between a state releasing the holding state of holding the tube The medical device of claim 1.