JP6884538B2 - Connection ports and medical devices - Google Patents

Description

The present invention relates to connection ports and medical devices.

Various treatment methods have been conventionally known as treatment methods for lesions in the living lumen. For example, in Patent Document 1, a guide wire is inserted in advance of a lesion, and then a medical device provided with a guide wire lumen is inserted into the biological lumen along the guide wire to the lesion. The method of performing a predetermined diagnosis and treatment is disclosed.

Special table No. 10-500584

For example, when treating a lesion in the lower extremity, a medical device is inserted through a blood vessel such as the ipsilateral femoral artery, the contralateral femoral artery, or the radial artery. The distance from the insertion point of the medical device into the living body to the lesion depends on which blood vessel the medical device is inserted through. In addition, the distance from the insertion site of the medical device into the living body to the lesion site varies from patient to patient.

Here, in the medical device according to Patent Document 1 described above, since the length (effective length) that can be inserted into the living body of the medical device is fixed, for example, the effective length is into the living body of the medical device. If it is longer than the distance from the insertion point of the medical device to the lesion, the length of the guide wire sheath extending from the insertion point of the medical device to the outside of the body becomes long. When the length of the guide wire sheath extending outside the body becomes long in this way, when the guide wire is inserted from the base end of the guide wire sheath, the guide is also guided to a portion extending excessively outside the body. The wire must be passed through, and the operability of the guide wire is poor. In addition, the surgeon holds the medical device so that the medical device does not come out of the living body, and inserts the guide wire at a place away from the insertion point of the medical device into the living body. It must be, and the operability is poor.

The present invention has been made to solve the above-mentioned problems, and an object of the present invention is to provide a connection port and a medical device capable of improving operability by adjusting an effective length.

The connection port that achieves the above object has a first lumen through which a guide wire sheath having a guide wire lumen can be inserted, and the guide wire sheath is movable relative to the guide wire sheath. A puncture capable of puncturing the guide wire sheath by being inserted into the main body portion in a state where the main body portion is provided with a main body portion and a second lumen and the main body portion is positioned with respect to the guide wire sheath. It has a part and. The second lumen communicates with the guide wire lumen in a state where the puncture portion is punctured into the guide wire sheath. The puncture portion has a needle portion with a sharp tip and a shaft portion provided on the base end side of the needle portion, and the main body portion includes a lumen for the needle portion through which the needle portion can be inserted. The shaft portion has a recess through which the shaft portion can be inserted.

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 rotatable drive shaft can be inserted, and a guide wire sheath having a guide wire lumen arranged side by side with the image sheath and 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, and a first lumen through which the guide wire sheath can be inserted so as to be relatively movable with respect to the guide wire sheath. The guide wire sheath is provided with a main body portion for holding the guide wire sheath and a second lumen, and the main body portion is inserted into the main body portion in a state of being positioned with respect to the guide wire sheath. It has a connection port having a piercing portion that can be pierced. The second lumen communicates with the guide wire lumen in a state where the puncture portion is punctured into the guide wire sheath. The puncture portion has a needle portion with a sharp tip and a shaft portion provided on the base end side of the needle portion, and the main body portion includes a lumen for the needle portion through which the needle portion can be inserted. The shaft portion has a recess through which the shaft portion can be inserted.

According to a medical device having a connection port configured as described above, puncture is performed by puncturing the guide wire sheath with the main body positioned at a desired position of the guide wire sheath. The second lumen of the section communicates with the guide wire lumen. Therefore, the position of the connection port into which the guide wire is inserted can be appropriately adjusted, and the effective length, which is the length that can be inserted into the living body of the medical device, can be appropriately adjusted. Therefore, it is possible to provide a connection port and a medical device whose operability can be improved by adjusting the effective length.

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. FIG. 3A is a cross-sectional view taken along the axial direction showing the connection port of the medical device according to the embodiment, and FIG. 3A shows a state before the puncture portion is punctured by the sheath for the guide wire, and FIG. 3B ) Indicates a state in which the punctured portion is punctured by the sheath for the guide wire. 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. It is a top view which shows the medical device when the main body part is moved to the tip side. FIG. 8A is a cross-sectional view taken along the axial direction showing the connection port of the medical device according to the first modification, and FIG. 8A shows a state in which the puncture portion is punctured by the sheath for the guide wire, and FIG. 8B is shown in FIG. Indicates a state in which the puncture portion is removed from the guide wire sheath, and FIG. 8C shows a state in which the separation portion covers the hole formed in the guide wire sheath. It is a top view which shows the medical device which concerns on the modification 1 when the separation part covers the hole part formed in the sheath for a guide wire, and the main body part and the puncture part are moved to the proximal end side. FIG. 10A is a cross-sectional view taken along the axial direction showing the connection port of the medical device according to the modified example, and FIG. 10A shows a state before the puncture portion is punctured by the guide wire sheath, and FIG. ) Indicates a state in which the punctured portion is punctured by the sheath for the guide wire. FIG. 11A is a cross-sectional view taken along the axial direction showing the connection port of the medical device according to the modified example, and FIG. 11A shows a state before the puncture portion is punctured by the guide wire sheath, and FIG. ) Indicates a state in which the punctured portion is punctured by the sheath for the guide wire.

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 living lumen such as a blood vessel. Lumen. 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 living lumen, an operating portion 3 in which an operator performs a predetermined operation, and a tissue in the living lumen. An imaging core 4 that transmits and receives ultrasonic waves toward the shaft, a connection port 5 that holds the shaft 2 so as to be relatively movable with respect to the shaft 2, and a connection port 5 into which a guide wire W is inserted from the proximal end side. It has.

In the medical device 1 according to the present embodiment, the tip side of the connection port 5 from the tip 51A can be inserted into the living body. That is, in the medical device 1, the tip 1A of the medical device 1 can be inserted into the living body from the tip 51A of the connection port 5. In the following description, the length from the tip 51A of the connection port 5 to the tip 1A of the medical device 1 is referred to as an effective length.

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 of the living lumen taken by X-ray photography from outside the body. The constituent material of the guide wire W is not particularly limited as long as it can be observed by angio image, but for example, a metal such as stainless steel, spring steel, titanium, tungsten, tantalum, superelastic alloy such as 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.

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 shaft portion 2 is formed of a flexible material, and the material is not particularly limited, and 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 transmission.

As shown in FIGS. 1, 3, and 4, the operation unit 3 has a tip end connected to an image sheath 61 and a base end portion connectable to an external drive device 7 for operating the imaging core 4. It is configured. As shown in FIG. 1, the operation unit 3 is connected to an outer tube 31 connected to the image sheath 61, an inner tube 32 arranged inside the outer tube 31, and a base end portion of the outer tube 31. It includes a unit connector 33 and an operation base end portion 34 connected to a base end portion of the inner pipe 32. 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 image sheath 61, and the base end is connected to the unit connector 33. The outer tube 31 has kink resistance and is formed on a substantially straight line. As a result, the outer tube 31 secures a path for the inner tube 32 to move in the axial direction in the lumen.

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 tube 32 is pushed most toward the tip end side, the end portion of the inner tube 32 moves inside the outer tube 31 and reaches the vicinity of the tip end of the outer tube 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. For ease of understanding, the inner tube 32 is omitted in FIG.

Further, when the inner tube 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 tube 32 is caught on the inner wall of the unit connector 33, and the base of the inner tube 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 proximal 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) included in 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 a signal line 43 (see FIG. 2) is connected to the hub-side connector 343, and the signal line 43 passes through the drive shaft 42 and the other end is an oscillator as shown in FIG. It is connected to the unit 41. Ultrasonic waves are emitted from the vibrator unit 41 by a signal transmitted from the external drive device 7 to the vibrator unit 41 via the drive side connector 711, the hub side connector 343, and the signal line 43. Further, the signal detected by the vibrator 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 lumen 25 for an image, and is configured to be movable back and forth in the axial direction relative to the shaft portion 2. The imaging core 4 includes a vibrator unit 41 capable of transmitting and receiving ultrasonic waves from the lumen of a living body toward a living tissue to acquire image information, a drive shaft 42 to which the vibrator unit 41 is attached to a tip and rotated. have. The vibrator unit 41 is composed of an ultrasonic vibrator 411 that transmits and receives ultrasonic waves, and a housing 412 that houses the ultrasonic vibrator 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. In FIG. 3, the drive shaft 42 is omitted for ease of understanding.

As shown in FIGS. 1 and 3, the connection port 5 is movable relative to the image sheath 61 and the guide wire sheath 62 (shaft portion 2), so that the image sheath 61 and the guide wire can be moved. It has a main body 51 that holds the sheath 62, and a puncture portion 52 that can be inserted into the main body 51 to puncture the guide wire sheath 62.

As shown in FIGS. 3A and 3B, the main body 51 can be inserted with the first lumen 51a through which the image sheath 61 and the guide wire sheath 62 can be inserted, and the needle portion 52a of the puncture portion 52. It has a lumen 51b for the needle portion and a recess 51c through which the first shaft portion 52b of the puncture portion 52 can be inserted.

The puncture portion 52 includes a needle portion 52a having a sharp tip, a first shaft portion (corresponding to a shaft portion) 52b, and a second shaft portion 52c in order from the tip. The first shaft portion 52b has a larger outer diameter than the needle portion 52a, and the second shaft portion 52c has a larger outer diameter than the first shaft portion 52b. Further, the puncture portion 52 has a second lumen 52d through which the guide wire W can be inserted.

As shown in FIGS. 3A and 3B, the image sheath 61 and the guide wire sheath 62 are inserted into the first lumen 51a. The first lumen 51a is configured to be curved outward (lower side) in the radial direction from the tip end to the base end end. The image sheath 61 and the guide wire sheath 62 extend from the base end 51x of the first lumen 51a. The distance extending from the base end 51x of the first lumen 51a of the image sheath 61 and the guide wire sheath 62 increases as the main body 51 moves toward the tip of the shaft 2 (see FIGS. 1 and 7). ). The image sheath 61 projecting from the base end 51x of the first lumen 51a is connected to the tip end portion of the outer tube 31. Therefore, the physiological saline solution that has passed through the outer tube 31 can move to the image lumen 25. The image sheath 61 and the guide wire sheath 62 are configured to be in contact with the first lumen 51a to such an extent that the main body 51 can move with respect to the image sheath 61 and the guide wire sheath 62.

The needle portion 52a of the puncture portion 52 is inserted into the lumen 51b for the needle portion. The lumen 51b for the needle portion is configured to be continuous with the space in which the guide wire sheath 62 is arranged in the first lumen 51a along the axial direction, but is a space in which the image sheath 61 is arranged. Is not configured to be continuous along the axial direction. The needle portion 52a of the puncture portion 52 is configured to be in contact with the needle portion lumen 51b to such an extent that the needle portion 52a can move with respect to the needle portion lumen 51b.

The first shaft portion 52b of the puncture portion 52 is inserted into the recess 51c. The recess 51c is configured to be continuous with the needle lumen 51b along the axial direction. The first shaft portion 52b of the puncture portion 52 is configured to be in contact with the recess 51c to such an extent that the first shaft portion 52b can move with respect to the recess 51c.

According to the connection port 5 configured as described above, the puncture portion is as shown in FIG. 3B in a state where the main body portion 51 is positioned at desired positions of the image sheath 61 and the guide wire sheath 62. By inserting the 52 into the main body 51, the needle portion 52a of the puncture portion 52 is punctured by the guide wire sheath 62. At this time, as shown in FIG. 3B, the second lumen 52d communicates with the guide wire lumen 26. Since such a connection port 5 is provided, the position of the connection port 5 into which the guide wire is inserted can be appropriately adjusted, and the effective length of the medical device 1 (indicated by reference numeral L1 in FIGS. 1 and 5). (Represented by reference numeral L2 in FIG. 7) can be adjusted as appropriate.

The constituent materials of the main body 51, the outer tube 31, the inner tube 32, the unit connector 33, and the operating base end portion 34 are not particularly limited, and are, for example, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4). -Methylpentene-1), polycarbonate, acrylic resin, acrylic nitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate and polyethylene naphthalate, butadiene-styrene copolymer, polyamide (for example, nylon 6, nylon 6.6) , Nylon 6/10, Nylon 12), and various other resins.

The constituent material of the puncture portion 52 is not particularly limited, and is made of, for example, stainless steel.

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 gripping 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. 1 to 7, 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. In the following description, the case of observing two lesions formed in the blood vessels of the lower limbs of the patient will be described as an example. In the present embodiment, first, an image of the first lesion located at the length of L1 is acquired from the insertion point of the medical device 1 into the living body, and then the medical device 1 is inserted into the living body. The case of acquiring an image of a second lesion located at a length of L2 shorter than L1 from a location will be described.

First, as step S1, the puncture portion 52 is punctured with the guide wire sheath 62 in a state where the main body portion 51 is positioned at a desired position of the shaft portion 2 (image sheath 61 and guide wire sheath 62).

In order to puncture the puncture portion 52 into the guide wire sheath 62, the operator first performs the distance from the insertion point of the medical device 1 into the living body to the first lesion portion and the second lesion portion. Know the distance. When the distance from the insertion point of the medical device 1 into the living body to the first lesion is L1, the length from the tip 51A of the main body 51 to the tip 1A of the medical device 1 as shown in FIG. The main body 51 is positioned with respect to the shaft 2 so that the (effective length of the medical device 1) is L1. Then, in this state, as shown in FIG. 3B, by inserting the puncture portion 52 into the main body portion 51, the needle portion 52a of the puncture portion 52 is punctured with the guide wire sheath 62. As a result, the second lumen 52d of the puncture portion 52 communicates with the guide wire lumen 26, and the effective length of the medical device 1 can be set to L1.

Next, as step S2, a priming process is performed in which 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 the air in the medical device 1 is removed to prevent the 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 portion 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, 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 shaft portion 52c of the puncture portion 52, for example, using a syringe or the like. The injected saline solution is filled in the guide wire lumen 26 through the second lumen 52d, and the 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 S3, 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.

Next, as step S4, the guide wire W is inserted into the blood vessel via the introducer inserted into the blood vessel. Next, 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 puncture 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 located behind the lesion portion to be observed. Place it on the (tip side). At this time, a contrast medium or a drug can be supplied to the guide wire lumen 26 and discharged from the tip opening 62a into the living body.

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 into the outer tube 31 most 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 S5, 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 S6, by performing a pullback operation while rotating the drive shaft 42 by the drive unit 71, the ultrasonic vibrator 411 is moved along the axial direction from the affected portion toward the proximal end side while performing radial scanning. Thereby, a 360 ° tomographic image of the surrounding tissue in the axial direction in the blood vessel including the first lesion 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.

At this time, for example, when the effective length of the medical device is longer than the distance from the insertion point of the medical device into the living body to the lesion part, the shaft portion extending outside the body from the insertion point of the medical device 1 (image). The length of the sheath for the guide wire and the sheath for the guide wire is increased. When the length of the shaft portion extending outside the body becomes long in this way, when the guide wire W is pushed forward, the guide wire W must also pass through the excessively extending portion outside the body. The operability is poor. Further, the surgeon holds the medical device so that the medical device does not come out of the living body, while inserting the guide wire W at a place away from the insertion point of the medical device 1 into the living body. The operability is poor.

On the other hand, in the case of the medical device 1 according to the present embodiment, the position of the connection port 5 so that the effective length of the medical device 1 corresponds to the distance from the insertion point of the medical device 1 to the lesion part. Is adjusted so that the guide wire sheath 62 does not extend excessively outside the body. Therefore, the guide wire W does not pass through the portion that extends excessively outside the body, and the operability is improved. Further, since the work of inserting the guide wire W can be performed in the vicinity where the medical device 1 is held so that the medical device 1 does not come out of the living body, the operability is improved.

Next, as step S7, the main body 51 of the connection port 5 is moved to the tip end side of the shaft 2.

In order to move the main body 51 to the tip end side of the shaft 2, first, as shown in FIG. 3B, the puncture portion 52 punctured with respect to the guide wire sheath 62 is removed from the guide wire sheath 62. To do. Then, when the distance from the insertion point of the medical device 1 into the living body to the second lesion is L2, as shown in FIG. 7, the main body so that the effective length of the medical device 1 is L2. The portion 51 is moved to the tip end side of the shaft portion 2 to position the main body portion 51 with respect to the shaft portion 2. Then, in this state, as shown in FIG. 3B, the puncture portion 52 is inserted into the main body portion 51 again to puncture the needle portion 52a of the puncture portion 52 into the guide wire sheath 62. As a result, the second lumen 52d of the puncture portion 52 communicates with the guide wire lumen 26, and the effective length of the medical device 1 can be set to L2. In this state, by performing the step S6, a 360 ° tomographic image of the surrounding tissue in the axial direction in the blood vessel including the second lesion is obtained by scanning to an arbitrary position.

Next, as step S8, the medical device 1 is removed from the living lumen. 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. The treatment catheter device is then inserted into the living lumen along the guide wire W.

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

As described above, in the treatment method using the medical device 1 according to the present embodiment, the puncture portion 52 is inserted into the main body portion 51 with the main body portion 51 positioned at a desired position of the guide wire sheath 62. Includes a step of puncturing the guide wire sheath 62 with the puncture portion 52 and communicating the second lumen 52d of the puncture portion 52 with the guide wire lumen 26.

Further, a step of removing the puncture portion 52 punctured with respect to the guide wire sheath 62 from the guide wire sheath 62, a step of moving the main body portion 51 to the tip side along the guide wire sheath 62, and again. It includes a step of inserting the puncture portion 52 into the main body portion 51.

As described above, the connection port 5 according to the present embodiment includes the first lumen 51a through which the guide wire sheath 62 including the guide wire lumen 26 can be inserted, and is movable relative to the guide wire sheath 62. A main body 51 that holds the guide wire sheath 62 and a second lumen 52d are provided, and the main body 51 is inserted into the main body 51 in a state of being positioned with respect to the guide wire sheath 62 to guide the guide. The second lumen 52d communicates with the guide wire lumen 26 in a state where the piercing portion 52 is capable of piercing the wire sheath 62 and the piercing portion 52 is pierced by the guide wire sheath 62.

Further, as described above, the medical device 1 according to the present embodiment is a medical device 1 for inserting into a living lumen and acquiring an image. The medical device 1 includes an image sheath 61 having an image lumen 25 through which a rotatable drive shaft 42 can be inserted, and a guide wire lumen 26 which is arranged side by side with the image sheath 61 and into which a guide wire W can be inserted. The guide wire sheath 62 includes a guide wire sheath 62, a vibrator unit 41 fixed to the tip of the drive shaft 42 and capable of acquiring image information, and a first lumen 51a through which the guide wire sheath 62 can be inserted. A main body 51 that holds the guide wire sheath 62 so as to be relatively movable with respect to the other, and a second lumen 52d are provided, and the main body 51 is positioned on the main body 51 with respect to the guide wire sheath 62. A second connection port 5 having a puncture portion 52 capable of piercing the guide wire sheath 62 by being inserted, with the puncture portion 52 pierced into the guide wire sheath 62. The lumen 52d communicates with the guide wire lumen 26.

According to the medical device 1 provided with the connection port 5, the puncture portion 52 is punctured into the guide wire sheath 62 in a state where the main body portion 51 is positioned at a desired position of the guide wire sheath 62. The second lumen 52d of the puncture portion 52 communicates with the guide wire lumen 26. Therefore, the position of the connection port 5 into which the guide wire W is inserted can be appropriately adjusted, and the effective length, which is the length that can be inserted into the living body of the medical device 1, can be appropriately adjusted. Therefore, it is possible to provide the connection port 5 and the medical device 1 whose operability can be improved by adjusting the effective length.

Further, the puncture portion 52 has a needle portion 52a having a sharp tip and a first shaft portion 52b provided on the base end side of the needle portion 52a, and the main body portion 51 can be inserted with the needle portion 52a. It has a lumen 51b for the needle portion and a recess 51c through which the first shaft portion 52b can be inserted. Therefore, by inserting the puncture portion 52 into the main body portion 51, the needle portion 52a of the puncture portion 52 can be more preferably punctured into the guide wire sheath 62.

<Modification example 1>
Next, the configuration of the medical device 100 according to the first modification will be described with reference to FIGS. 8 and 9. The medical device 100 according to the first modification has a different configuration of the main body 151 of the connection port 150 as compared with the medical device 1 according to the above-described embodiment. FIG. 8 is a cross-sectional view taken along the axial direction showing the connection port 150 of the medical device 100 according to the first modification, and FIG. 8 (A) shows a state in which the puncture portion 52 is punctured by the guide wire sheath 62. 8 (B) shows a state in which the puncture portion 52 is removed from the guide wire sheath 62, and FIG. 8 (C) shows a hole portion in which the separation portion 153 is formed in the guide wire sheath 62. The state of covering 62b is shown.

As shown in FIG. 8, the connection port 150 of the medical device 100 according to the first modification has a main body portion 151 and a puncture portion 52. Since the puncture portion 52 has the same configuration as that of the above-described embodiment, the description thereof will be omitted.

The main body portion 151 includes a separation portion 153 that can be separated from the main body portion 151. The main body portion 151 is provided with a cut line 154, and the separation portion 153 is separated from the main body portion 151 by being cut off by the cut line 154.

As shown in FIG. 8C, the separation portion 153 can close the hole portion 62b formed in the guide wire sheath 62 when the puncture portion 52 is punctured into the guide wire sheath 62. As long as the separation unit 153 is configured to be separable from the main body portion 151, the configuration of the separation unit is not particularly limited.

Next, an operation when observing a living tissue from inside a living lumen such as a blood vessel will be described using the medical device 100 according to the first modification. In the following description, the case of observing two lesions formed in the blood vessels of the lower limbs of the patient will be described as an example. In the first modification, first, an image of a second lesion located at the length of L2 is acquired from the insertion point of the medical device 100 into the living body, and then the medical device 100 is introduced into the living body. The case of acquiring an image of the first lesion located at the length of L1 longer than L2 from the insertion point will be described.

Since the steps of step S1 and step S7 are different from the steps of the above-described embodiment in the procedure according to the modified example 1, the steps of steps S1 and S7 will be described here.

In step S1, the puncture portion 52 is punctured with the guide wire sheath 62 in a state where the main body portion 151 is positioned at a desired position of the shaft portion 2 (image sheath 61 and guide wire sheath 62).

In order to puncture the puncture portion 52 into the guide wire sheath 62, the operator first performs the distance from the insertion point of the medical device 100 into the living body to the second lesion portion and the first lesion portion. Know the distance. When the distance from the insertion point of the medical device 100 into the living body to the second lesion is L2, as shown in FIG. 7, the main body 151 so that the effective length of the medical device 100 is L2. Is positioned with respect to the shaft portion 2. Then, in this state, as shown in FIG. 8A, by inserting the puncture portion 52 into the main body portion 151, the needle portion 52a of the puncture portion 52 is punctured with the guide wire sheath 62. As a result, the second lumen 52d of the puncture portion 52 communicates with the guide wire lumen 26, and the effective length of the medical device 100 can be set to L2.

As step S7, the main body portion 151 of the connection port 150 is moved to the proximal end side of the shaft portion 2.

In order to move the main body portion 151 to the base end side of the shaft portion 2, first, as shown in FIGS. 8A and 8B, the puncture portion 52 punctured with respect to the guide wire sheath 62 is guided. Remove from the wire sheath 62. At this time, the guide wire sheath 62 is formed with a hole 62b due to the puncture portion 52 being punctured. Then, the separation portion 153 is cut off from the main body portion 151 at the cut line 154 to separate the separation portion 153 from the main body portion 151. Then, as shown in FIG. 8C, the position of the separating portion 153 is adjusted so as to cover the hole portion 62b formed in the guide wire sheath 62.

Then, when the distance from the insertion point of the medical device 100 into the living body to the first lesion is L1, as shown in FIG. 9, the medical device 1 is separated so that the effective length is L1. The main body portion 151 from which the portion 153 is separated is moved to the base end side of the shaft portion 2, and the main body portion 151 from which the separated portion 153 is separated is positioned with respect to the shaft portion 2. Then, in this state, as shown in FIG. 8A, the puncture portion 52 is inserted into the main body portion 151 again to puncture the needle portion 52a of the puncture portion 52 into the guide wire sheath 62. As a result, the second lumen 52d of the puncture portion 52 communicates with the guide wire lumen 26, and the effective length of the medical device 100 can be set to L1. In this state, by performing the step S6, a 360 ° tomographic image of the surrounding tissue in the axial direction in the blood vessel including the first lesion is obtained by scanning to an arbitrary position.

As described above, the treatment method using the medical device 100 according to the first modification is the step of removing the puncture portion 52 punctured by the guide wire sheath 62 from the guide wire sheath 62 and the separation portion 153. The step of separating the main body portion 151 from the main body portion 151, the step of moving the separation portion 153 so as to cover the hole portion 62b formed in the guide wire sheath 62, and the step of moving the main body portion 151 along the guide wire sheath 62 to the base end side. A step of moving the puncture portion 52 to the main body portion 151 and a step of inserting the puncture portion 52 into the main body portion 151 again are included.

As described above, the connection port 150 of the medical device 100 according to the first modification is provided in the main body portion 151 and has a separation portion 153 that can be separated from the main body portion 151. Therefore, even if the main body portion 151 is moved to the base end side, the separation portion 153 can cover the hole portion 62b formed by the puncture portion 52 puncturing the guide wire sheath 62. Therefore, it is possible to prevent blood from unintentionally leaking to the outside of the medical device 100 through the hole 62b. In particular, when the hole 62b comes out of the blood vessel during the procedure, it is possible to prevent blood from spilling out. Further, since the hole portion 62b is covered by the separation portion 153, it is possible to prevent the guide wire W from coming out of the medical device 100 through the hole portion 62b when the guide wire W is moved to the tip side, and medical treatment can be performed. The tip of the device 100 can be suitably reached.

Although the medical devices 1 and 100 according to the present invention have been described above through the embodiments and modifications, the present invention is not limited to each of the described configurations, and is appropriately modified based on the description of the scope of claims. It is possible to do.

For example, as shown in FIGS. 10A and 10B, the recess 51c of the main body 51 is provided with a recess 51e that is recessed outward in the radial direction, and the first shaft portion 52b of the puncture portion 52 is provided with a concave portion in the radial direction. A convex portion 52e protruding toward the main body portion 52e may be provided so that the puncture portion 52 can be fixedly provided to the main body portion 51 in a state where the puncture portion 52 is inserted into the main body portion 51. According to this configuration, the puncture state of the puncture portion 52 with respect to the guide wire sheath 62 can be easily maintained, so that the easiness of surgery is improved. Further, the means for fixing the puncture portion 52 to the main body portion 51 is not limited to the above-mentioned fitting, and may be screwing.

Further, as shown in FIG. 11, the main body portion 51 and the puncture portion 52 are connected, and the puncture portion 52 and the main body portion 51 are separated from each other in a state where the puncture portion 52 is punctured with the guide wire sheath 62. It may further have an elastic portion 90 that punctures the wire. According to this configuration, since the puncture portion 52 is fixedly provided to the main body portion 51, loss of the puncture portion 52 can be prevented. Further, the work of removing the puncture portion 52 from the guide wire sheath 62 becomes easy.

Further, in the above-described modification 1, the separation portion 153 covers the hole portion 62b to prevent blood from unintentionally leaking to the outside of the medical device 100 through the hole portion 62b. Not limited to this, for example, by applying a quick-drying adhesive to the guide wire sheath 62 in which the hole 62b is formed to close the hole 62b, blood unintentionally flows through the hole 62b. It may be prevented from leaking to the outside of the medical device 100. Further, the guide wire sheath 62 can be covered, and the hand portion is provided with a cover sheath configured to be screwed or snap-fitted to the second shaft portion 52c of the puncture portion 52, and the cover sheath covers the hole portion 62b. This may prevent blood from unintentionally leaking to the outside of the medical device 100 through the hole 62b.

Further, in the above-described 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 can also be applied to a catheter for image diagnosis that acquires an image using light such as optical interference tomography (OCT), and it can be applied to 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 interference tomographic diagnosis method.

Further, the medical device to which the medical tube according to the present invention is applied is not limited to a diagnostic imaging catheter, and for example, a microcatheter, a guiding catheter, a balloon catheter, a self-expandable stent delivery system, and a balloon-expandable stent delivery. Systems, contrast catheters, ateletomy catheters, endoscopic catheters, drug solution administration catheters and the like can be applied.

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 operation unit does not have a double pipe structure composed of an outer pipe and an inner pipe, and the drive shaft is fixed in the axial direction at an arbitrary position.

1,100 medical devices,
25 Lumens for images,
26 Guide wire lumen,
41 Oscillator unit (imaging unit),
42 drive shaft,
5,150 connection ports,
51, 151 main body,
51a 1st lumen,
51b Lumen for needle,
51c recess,
52 Puncture,
52a Needle part,
52b 1st shaft part (shaft part),
52d 2nd lumen,
153 Separation part,
61 Image sheath,
62 Guide wire sheath,
90 elastic part,
W guide wire.

Claims (5)

A main body having a first lumen through which a guide wire sheath having a guide wire lumen can be inserted and holding the guide wire sheath so as to be relatively movable with respect to the guide wire sheath.
It has a second lumen, and has a puncture portion capable of puncturing the guide wire sheath by being inserted into the main body portion in a state where the main body portion is positioned with respect to the guide wire sheath.
In a state where the puncture portion is punctured with respect to the guide wire sheath, said second lumen is in communication with the guide wire lumen,
The puncture portion has a needle portion with a sharp tip and a shaft portion provided on the base end side of the needle portion.
The body portion is closed and a needle unit lumen which can be inserted the needle portion, and a recess capable the shank through the connection port. A main body having a first lumen through which a guide wire sheath having a guide wire lumen can be inserted and holding the guide wire sheath so as to be relatively movable with respect to the guide wire sheath.
A puncture portion provided with a second lumen and capable of puncturing the guide wire sheath by being inserted into the main body portion in a state where the main body portion is positioned with respect to the guide wire sheath.
It has a separating portion provided in the main body portion and separable from the main body portion.
A connection port in which the second lumen communicates with the guide wire lumen in a state where the puncture portion is punctured into the guide wire sheath. A main body having a first lumen through which a guide wire sheath having a guide wire lumen can be inserted and holding the guide wire sheath so as to be relatively movable with respect to the guide wire sheath.
It has a second lumen, and has a puncture portion capable of puncturing the guide wire sheath by being inserted into the main body portion in a state where the main body portion is positioned with respect to the guide wire sheath.
With the puncture portion punctured into the guide wire sheath, the second lumen communicates with the guide wire lumen.
Connection port the puncture section that is provided to be fixed to the main body portion. A main body having a first lumen through which a guide wire sheath having a guide wire lumen can be inserted and holding the guide wire sheath so as to be relatively movable with respect to the guide wire sheath.
A puncture portion provided with a second lumen and capable of puncturing the guide wire sheath by being inserted into the main body portion in a state where the main body portion is positioned with respect to the guide wire sheath.
With connecting the body portion and the puncture, in the state where the puncture portion punctured with respect to the guide wire sheath, an elastic portion for urging the puncture section and the main body portion so as to be spaced apart from each other, the Have and
A connection port in which the second lumen communicates with the guide wire lumen in a state where the puncture portion is punctured into the guide wire sheath. 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 a rotatable drive shaft can be inserted,
A guide wire sheath arranged side by side with the image sheath and provided with a guide wire lumen through which the guide wire can be inserted,
An imaging unit fixed to the tip of the drive shaft and capable of acquiring image information,
The main body is provided with a first lumen through which the guide wire sheath can be inserted and holds the guide wire sheath so as to be relatively movable with respect to the guide wire sheath, and a second lumen. It has a connection port provided with a puncture portion capable of puncturing the guide wire sheath by being inserted into the main body portion in a state where the portion is positioned with respect to the guide wire sheath.
In a state where the puncture portion is punctured with respect to the guide wire sheath, said second lumen is in communication with the guide wire lumen,
The puncture portion has a needle portion with a sharp tip and a shaft portion provided on the base end side of the needle portion.
The main body is a medical device having a lumen for a needle through which the needle can be inserted and a recess through which the shaft can be inserted.

Images