WO2017033712A1

WO2017033712A1 - Medical device

Info

Publication number: WO2017033712A1
Application number: PCT/JP2016/073179
Authority: WO
Inventors: 秀治狩谷; 昇谷川; 秀和当瀬; 秀昭柳原
Original assignee: 学校法人関西医科大学; 株式会社ハイレックスコーポレーション
Priority date: 2015-08-21
Filing date: 2016-08-05
Publication date: 2017-03-02
Also published as: JP2017038884A; JP6753655B2

Abstract

The purpose of the present invention is to provide: a stylet wire for facilitating leading movement of a catheter so that the catheter is moved to a target luminal branch; and a medical device capable of applying torque to the catheter while performing tasks such as releasing of a pharmaceutical agent such as a contrast medium, or suctioning of blood or the like, through the catheter, with the inserted stylet remaining in the catheter. The medical device (1) according to the present invention is provided with a catheter (2), a stylet wire (3), and a catheter torquer hub (5) for applying torque to the catheter while injecting a contrast medium, wherein the stylet wire (3) has an outer diameter enabling a pharmaceutical agent to be introduced into an end (2a) of the catheter (2), a pharmaceutical agent can be released into a body lumen with the inserted stylet wire (3) remaining in the catheter (2), and the stylet wire (3) can hold the end (2a) of the catheter (2) in a bent position.

Description

Medical device

The present invention relates to a medical device. More specifically, the present invention relates to a medical device including a catheter capable of releasing a fluid such as a medicine.

A catheter that is inserted into a body cavity such as a blood vessel and discharges a drug such as a contrast agent or sucks blood or the like from its tip is used for diagnosis and treatment of a target site and prevention of a disease ( For example, Patent Document 1).

When using the catheter for angiography, insert the catheter into the blood vessel and push it to the target site. Specifically, a guide wire capable of giving an angle shape as shown in Patent Document 1 is inserted from the guide wire introduction opening to the distal end of the catheter body, and the distal end of the guide wire is extended from the distal end of the catheter. While maintaining the state where the guide wire is advanced with respect to the catheter, the guide wire is rotated in the blood vessel to change the direction of the angled tip in the blood vessel, and the wire is pushed and pulled to obtain the target blood vessel. Insert the wire. When the wire enters the target blood vessel, the wire is held, and the tip of the catheter is inserted into the target blood vessel by following the wire. To perform this operation, it is necessary for the surgeon to grasp the travel of the blood vessel. Before the catheter is advanced to the target blood vessel, the contrast medium is released from the catheter, X-ray imaging is performed, and a map to the target blood vessel is obtained. Need to get. When the tip of the catheter reaches the target site, the preceding wire is removed, and a contrast agent is injected by an injection device such as a syringe and released from the catheter tip. The contrast medium released into the blood vessel is X-rayed to diagnose the blood vessel morphology and blood flow state. When a map to a new target blood vessel is obtained, the catheter is further advanced to the target blood vessel by the same method, and the final target blood vessel is reached. In this way, angiography is appropriately performed from the central large blood vessel, and branches are selected step by step to reach the final target peripheral blood vessel.

Japanese Patent Laid-Open No. 05-220225

In the above case, there are some problems shown below.

(1) When selecting a blood vessel with a guide wire, a guide wire having a tip shape suitable for the blood vessel must be used, and the shape of the tip must be formed by pulling out the guide wire every time a branch is selected. .
(2) Since it is necessary to determine a blood vessel branch that branches three-dimensionally on a two-dimensional map, the branch direction that goes perpendicular to the map plane is unknown.
(3) Since the wire is advanced with reference to the map acquired earlier and displayed on another screen, or the map superimposed on the same screen, the position of the blood vessel to which the wire is advanced and the map are shifted.
(4) When a blood vessel is selected, a guide wire is first used, but this guide wire gives a stimulus to the blood vessel and increases the risk of vasospasm and damage.
(5) Since the lumen cannot be secured unless the guide wire in the lumen of the catheter is pulled out, imaging cannot be performed. Therefore, since the contrast is necessary step by step, the guide wire must be removed each time.

In order to solve all the problems described in (1) to (5) above when the catheter reaches the target blood vessel, the following three solutions (A) to (C) were conceived.
(A) The conventional catheter insertion method preceding the guide wire is stopped and the catheter is advanced.
(B) According to the shape of the blood vessel, the operator proceeds while forming an arbitrary curve in three dimensions without removing the catheter.
(C) Release the contrast agent from the catheter tip in real time, find out whether the catheter tip is suitable for the blood vessel to be inserted, and how far the intravascular progression is, and whether the catheter tip is always directed to the target blood vessel Determine.

And in order to execute the three solutions (A) to (C) described above, the following two devices were invented.

<Stylet wire>
The operation of selecting a blood vessel using only a catheter may still be performed. However, the catheter is flexible, so that no pushing / pulling force is applied from the hand, and no torque is transmitted. In order to solve this problem, a stylet wire is provided inside the catheter. Thereby, the force and torque of pushing and pulling can be transmitted to the catheter tip. There are active catheters as shown in the patent literature aiming to point the tip in the intended direction with the catheter advanced. These procedures are complicated and are very different from the commonly used catheter operation. Further, the catheter becomes complicated, and it is not realistic to reduce the diameter and secure a wide lumen. The system of the present invention can also orient the catheter tip in the direction intended by the operator. In this, an arbitrary shape is provided on the stylet wire, an arbitrary shape is also provided on the catheter tip, and this combination allows the operator to always change the shape according to the blood vessel shape without removing the catheter into an arbitrary three-dimensional shape. it can. This combination of shaping and catheter rotation allows the catheter tip to be directed in the direction intended by the operator. The ability to orient in the intended direction compared to an active catheter may be more or less depending on the situation, but when the stylet is removed, the catheter has the same simple structure as a conventional catheter. Follow-up performance can be achieved. Appropriate space is provided in the stylet wire and catheter to allow the drug to pass through.

<Catheter torquer hub with side branch>
Conventionally, a torquer is attached to a wire in order to select a blood vessel in advance of the wire. However, since the system of the present invention advances the catheter in advance, it is necessary to transmit torque delicately to the catheter, and a catheter torquer is required. A syringe is provided on the vertical line of the catheter, the inner cylinder of the syringe is fixed to the operator's right palm, the syringe inner cylinder is pushed in, and the contrast medium filled in the syringe is injected. By pinching and rotating, a side-branched catheter torquer hub (hereinafter referred to as a catheter torquer hub) connected to the syringe outer cylinder can be operated as a torquer. To explain further, the syringe inner cylinder is pushed and fixed by the palm and kept from rotating, but the syringe is structured to be able to rotate the outer cylinder while pushing the inner cylinder. The catheter torquer hub has a role of connecting the syringe outer cylinder and the catheter so that the outer cylinder can be effectively used as a torquer. Push and pull operations are performed simultaneously with the left hand. As a result, it is possible to inject and release the contrast agent in real time while rotating and pushing the catheter. However, in order to manipulate the stylet wire, the proximal side of the stylet wire must exit the catheter. In order to prevent this stylet wire from interfering with catheter operation and contrast medium injection operation, considering the shape of the hand holding the syringe as described above, the stylet wire is avoided from the hand to the minimum, and there is no hindrance to rotation. A side branch is provided to escape at an angle. By imaging in real time, it can be seen that the catheter is always directed toward the target blood vessel. If the contrast medium is injected while the curved catheter tip is in a certain direction, laminar flow occurs due to the difference in specific gravity between the contrast medium and blood. If the target blood vessel is rendered, the process proceeds. If not, the process proceeds with rotation stopped when the target blood vessel is rendered. Further, if the blood vessel is moved as it is when the blood vessel is not intended, the catheter is inserted into the blood vessel, so that the catheter is advanced at a timing when the catheter is not rotated and rendered.

The medical device of the present invention based on the above two ideas is a catheter inserted into a body cavity, a stylet wire inserted into the catheter, a drug is injected into the catheter, and enters the body cavity. An infusion device for releasing the drug from one end of the catheter, a linear base, and a catheter torquer hub having a side branch obliquely communicating with the base, and one end of the base is provided with one end of the catheter. The other end is connected to the other end of the base, and the injection device is connected to the other end of the base, and the side branch has an insertion port through which the stylet wire is inserted on the other end side of the base. The diameter is smaller than the inner diameter of the catheter and is large enough to introduce the drug into one end of the catheter, and the stylet wire is inserted into the catheter. The drug can be injected and discharged from one end of the catheter into the body cavity in a state, and the stylet wire can be maintained in a state where the one end side of the catheter is bent. It is characterized by.

Further, it is preferable that the drug is a contrast medium.

In addition, it is preferable that the side branch includes a backflow prevention valve for preventing backflow of the medicine.

According to the medical device of the present invention, it is not necessary to remove the stylet wire when releasing a drug such as a contrast medium, and the drug such as a contrast medium can be released into the body cavity when necessary. it can.

It is the schematic which shows one Embodiment of the medical device of this invention. (A) is a schematic sectional drawing of the one end side of the catheter in the medical apparatus of FIG. 1, (b) is a figure which shows the catheter shape | molded by the two-dimensional S-shaped curve, (c) FIG. 3 is a view showing a catheter shaped in a three-dimensional S-curve shape. (A) is the schematic which shows the state which the end of the catheter of the medical device advanced to the front of the branch location of the blood vessel, and (b) is a branch by rotating one end of the catheter at the blood vessel branch location. It is the schematic which shows the state which is going to advance to the blood vessel. It is the schematic which shows the contrast image of the blood vessel when a contrast agent spreads over the whole blood vessel. It is the schematic which shows the contrast image which the catheter advances to the front of the branch location of the blood vessel, and the branch location was imaged. It is the schematic which shows the contrast image when the end of a catheter advances to a branch blood vessel, and the contrast agent and the blood form a laminar flow, and the state where the branch blood vessel heading to the target site is not imaged is shown. It is the schematic which shows the contrast image when one end of a catheter progresses to a branch blood vessel, and the contrast agent and the blood form the laminar flow, but the state where the branch blood vessel heading to the target site is imaged is shown . It is the schematic which shows the state in which the one end of the catheter faces the branch blood vessel which goes to the target site, and the branch blood vessel which goes to the target site is imaged. It is the schematic which shows the state which the catheter advanced into the branch blood vessel toward a target site | part. FIG. 6 is a schematic diagram showing the release of contrast agent as the catheter passes through a further branch in a branch vessel toward the target site. FIG. 6 is a schematic diagram showing the release of contrast agent as the catheter passes through a further branch in a branch vessel toward the target site. It is the schematic which shows the contrast image when the end of a catheter reaches | attains the target site | part.

Hereinafter, the medical device of the present invention will be described in detail with reference to the drawings. The medical device of embodiment shown below is an illustration to the last, and the medical device of this invention is not limited to drawing and the following embodiment.

As shown in FIG. 1, the medical device 1 according to the present embodiment includes a catheter 2 inserted into a body cavity, a stylet wire 3 inserted into the catheter 2, a drug is injected into the catheter 2, and And an injection device 4 for releasing a drug from one end of the catheter 2 that has entered the body cavity, a linear base 51, and a catheter torquer hub 5 having a side branch 52 that communicates obliquely with the base 51. . For example, the medical device 1 inserts a catheter 2 into a body cavity and discharges a drug from the one end 2a side (tip side) of the catheter 2, thereby diagnosing or treating a target site in humans or animals and treating diseases. Used for prevention.

As shown in FIG. 1 and FIG. 2 (a), the catheter 2 is a tube-shaped member, and by positioning one end 2a at a target site in a body cavity such as a blood vessel, a lymph vessel, a bile duct, or a digestive tract, Introduce drug to the site. The catheter 2 has a lumen 2c (see FIG. 2A) that communicates from one end 2a to the other end (base end) 2b, and is formed of a flexible material so as to be movable in a curved body cavity. Yes. In addition, the catheter 2 may have a shape such as a curve at the time of manufacture, and may be shaped according to the blood vessel by squeezing with a finger or the like during the operation. One end 2a of the catheter 2 moves to a target site in a body cavity such as a blood vessel and is positioned. The other end 2 b of the catheter 2 is connected to one end (end portion on the distal end side) 51 a of the base portion 51 of the catheter torquer hub 5. In order to visually recognize the position of the one end 2a of the catheter 2 on an image display device or the like under X-ray (radiation) imaging, an X-ray (radiation) opaque marker is provided on the outer periphery of at least the one end 2a side. It may be provided.

The stylet wire 3 is composed of an elongated metal wire. The stylet wire 3 is inserted from an insertion port 52a formed in the side branch 52 of the catheter torquer hub 5, and enters the lumen 2c of the catheter 2 via the lumen of the side branch 52 and the communication hole of the base 51 which will be described later. Has been passed. In this embodiment, one end (tip) 3a of the stylet wire 3 is located on the one end 2a side of the catheter 2 as shown in FIGS. 1 and 2A. The other end (not shown) of the stylet wire 3 is positioned on the hand side so that the remaining part of the stylet wire 3 is led out from the insertion opening 52a of the side branch 52 and the hand operation is possible. The material and structure of the stylet wire 3 are not particularly limited. For example, the material of the stylet wire 3 can be SUS, Ni—Ti alloy or the like, and the stylet wire structure is composed of a single wire or a stranded wire, or a single wire or a stranded wire as a core wire. And a single wire or stranded wire wound around the outer periphery in a coil shape. The distal end of the stylet wire 3 may have a shape such as a curve at the time of manufacture, and the operator may shape the shape according to the blood vessel during the operation.

The injection tool 4 is a member that injects a drug into the lumen 2 c of the catheter 2 via the catheter torquer hub 5. The drug supplied from the injection device 4 to the catheter 2 is a substance released into the body cavity for the purpose of treatment, examination, disease prevention, and the like. The drug is not particularly limited as long as it is a drug intended for treatment, examination, disease prevention, and the like, for example, a contrast agent, an anticancer agent, and a thrombolytic agent. In this embodiment, the contrast agent is taken as an example. I will explain. A contrast agent is administered to a patient in order to contrast an image or to image a specific tissue during image diagnosis. For example, when the catheter 2 travels in a body cavity such as a blood vessel, the contrast agent is released from the distal end of the catheter 2 into the body cavity, and the body cavity near the distal end of the catheter 2 is X-rayed, whereby the image display device 6 is used. (See FIGS. 4 to 7), it is possible to display a contrast image of a body cavity such as a blood vessel. In the present embodiment, as shown in FIG. 1, a syringe is used as the injection tool 4, but the injection tool 4 is not limited to a syringe as long as a drug can be injected into the catheter 2. For example, as an infusion device, an infusion bag may be used, or a medicine supply device including an infusion mechanism such as a pump may be used.

As shown in FIG. 1, the catheter torquer hub 5 connects the catheter 2 and the injection device 4 and introduces the stylet wire 3 into the catheter 2. As described above, the catheter torquer hub 5 includes the linear base 51 and the side branch 52 that communicates with the base 51 obliquely. The branch angle of the side branch 52 avoids the hand holding the syringe connected to the catheter torquer hub by the stylet wire to the minimum, and the rotational movement of the other end of the stylet wire 3 is minimized as the catheter is rotated. It is preferable that it is provided.

An opening (not shown) is formed in each of the one end 51a and the other end 51b of the base 51, and a communication hole (not shown) communicating from the one end 51a to the other end 51b of the base 51 is formed in the base 51. ing. This communication hole forms a supply path for a medicine supplied from the injection device 4 to the catheter 2. The other end 2 b of the catheter 2 is connected to one end 51 a on the distal end side of the base 51, and the injection tool 4 is connected to the other end 51 b on the proximal end side of the base 51. A catheter connecting portion C1 and an injecting device connecting portion C2 are provided on the one end 51a and the other end 51b side of the base 51, and the catheter 2 and the injecting device 4 can be connected to each other. In this embodiment, the other end 2b of the catheter 2 is directly connected to the catheter connection part C1, and the connection part 4a of the injection tool 4 is directly connected to the injection tool connection part C2. However, these connections may be indirectly connected through other members such as a connector (not shown). Moreover, in this embodiment, the outer surface of the connection part 4a of the injection tool 4 shown as a syringe is formed in the taper shape where a front-end | tip tapers, and the inner surface of the injection tool connection part C2 is the catheter 2 from the injection tool 4 side. It is formed in a tapered shape toward the side. That is, the connection part 4a of the injection tool 4 is inserted into the opening formed in the injection tool connection part C2 to be tapered. However, the connection between the injection tool 4 and the catheter torquer hub 5 is not limited to the above-described taper connection. For example, the connection between the injection tool 4 and the catheter torquer 5 by other connection methods such as screw connection. The hub 5 may be connected.

The side branch 52 is formed in a hollow shape, and a lumen (not shown) in the side branch 52 is connected by a connecting portion at an intermediate portion of the base 51 to communicate with the communication hole. The side branch 52 has an insertion port 52a into which the stylet wire 3 is inserted on the other end 51b side of the base 51 (the free end side of the side branch 52). The stylet wire 3 inserted from the insertion port 52 a of the side branch 52 is passed through the lumen 2 c of the catheter 2 via the lumen of the side branch 52 and the communication hole of the base 51. Thereby, the stylet wire 3 can move to the one end 2 a side of the catheter 2. The side branch 52 is formed obliquely with respect to the base 51, that is, the side branch 52 forms an acute angle with a portion from the connecting portion between the side branch 52 and the base 51 to the other end 51 b side of the base 51. Further, as shown in FIG. 1, the side branch 52 may include a backflow prevention valve 52 b that prevents the medicine injected from the other end 51 b of the base 51 from flowing back to the insertion hole 52. The backflow prevention valve 52b can be inserted through the stylet wire 3, and includes a slit, a switch, a cock and the like so as to prevent the medicine from leaking from the insertion port 52a of the side branch 52 when the medicine is injected. It only has to be.

Next, the stylet wire 3 and the catheter 2 in the medical device 1 of the present embodiment will be described in detail. In the present embodiment, the outer diameter of the stylet wire 3 is configured to be smaller than the inner diameter of the catheter 2 (the diameter of the lumen 2c) and to have a size capable of introducing the drug into the one end 2a side of the catheter 2. Yes. As a result, the medicine is injected from one end 2a of the catheter 2 with the stylet wire 3 inserted into the catheter 2, passes between the outer surface of the stylet wire 3 and the lumen 2c of the catheter 2, and passes through the catheter 2 It can be released from the tip of the body into the body cavity. That is, in this embodiment, the drug can be injected into the lumen 2 c of the catheter 2 and released from the one end 2 a of the catheter 2 without removing the stylet wire 3 from the catheter 2 to the proximal side. Therefore, since it is not necessary to remove the stylet wire 3 from the catheter 2 when injecting a drug such as a contrast medium, the procedure time can be shortened. In addition, it is possible to inject a required amount of a drug when necessary, and when the drug is injected at a plurality of locations in a body cavity, the removal and insertion of the stylet wire 3 is not necessary each time. The burden can be greatly reduced.

The size of the outer diameter of the stylet wire 3 that can be introduced into the end 2a side of the catheter 2 is such that the outer surface of the stylet wire 3 and the inner surface of the catheter 2 are as shown in FIG. A predetermined clearance is formed so that the drug can move between the two. The predetermined clearance here cannot be uniquely determined, but can be appropriately changed according to the inner diameter and material of the catheter 2 used, the viscosity of the medicine to be injected, and the like. Therefore, the size of the clearance between the outer surface of the stylet wire 3 and the inner surface of the catheter 2 is not particularly limited.

Moreover, in this embodiment, as shown in FIG. 1 and FIG. 2A, the distal end 3a side of the stylet wire 3 is configured to be maintained in a state where the one end 2a side of the catheter 2 is bent. ing. More specifically, as shown in FIGS. 1 and 2 (a), the one end 3a side of the stylet wire 3 is oriented in a predetermined direction, and the one end 2a side of the flexible catheter 2 is the stylet wire. 3 is deformed following the shape on the one end 3a side, and the stylet wire 3 becomes a core and is maintained in a bent state. Therefore, even if the catheter 2 itself is a flexible catheter that is not shaped, the stylet wire 3 is rotated around the axis of the stylet wire 3 as shown in FIGS. 3 (a) and 3 (b). Thus, the one end 2a of the catheter 2 is oriented in a desired direction. Therefore, the catheter 2 can be advanced in the intended direction at the branching point of the blood vessel. In addition, since the stylet wire 3 functions as a stylet for the catheter 2, even a small-diameter flexible catheter such as a microcatheter can easily transmit torque or pushing / pulling force to the one end 2 a of the catheter 2. Accordingly, the catheter 2 can be easily advanced from the hand to a thin peripheral blood vessel. In particular, traveling and branching of blood vessels are three-dimensional, and in order to advance in the intended direction as described above, three-dimensional orientation is required. The tip of the catheter 2 can be shaped from a straight line to a three-dimensional curve, and the tip of the stylet wire 3 can be shaped from a straight line to a three-dimensional curve. As described above, when both the catheter 2 and the stylet wire 3 have a two-dimensional curve shape, when the stylet wire 3 and the distal end of the catheter 2 are aligned as shown in FIG. However, when the tip of the stylet wire 3 is drawn behind the tip of the catheter 2 and turned in the opposite direction by 180 degrees on the same plane, a two-dimensional S-curve shape is created as shown in FIG. be able to. Further, when the stylet wire 3 is rotated 90 degrees with respect to the curve of the catheter 2, a three-dimensional S-shaped curve is obtained as shown in FIG. The catheter 2 and the stylet wire 3 are thus rotated in an arbitrary direction, and the distance by which the tip of the stylet wire 3 is pulled from the tip of the catheter 2 and the shapes of the catheter 2 and the stylet wire 3 are complicated. The direction is changed to an arbitrary direction by following a blood vessel that branches in three dimensions and is directed to a desired direction. When inserting into a target blood vessel, the shape of the previous blood vessel branch that has already passed and its followability are important, so the two-stage three-dimensional curve shape is important. In order to facilitate the rotation of the stylet wire 3 and to facilitate the transmission of torque to the one end 2a of the catheter 2, a torque device 7 (see FIG. 1) may be provided on the proximal side of the stylet wire 3. Good. As the torque device 7, a known torque device can be used, but it can be fixed to the catheter torquer hub 5 in order to restrict relative movement in the axial direction between the stylet wire 3 and the catheter 2. Also good. For example, the torque device 7 is provided with a connecting portion that can be attached to and detached from the catheter torquer hub 5, a connected member including the backflow prevention valve 52 b is provided at the free end of the side branch 52, and the connecting portion of the torque device 7 is used as the connected member. You may connect. The stylet wire 3 of this embodiment has the role of a stylet. However, the stylet wire 3 may be extended from the distal end of the catheter 2, select a blood vessel like a conventional guide wire, and advance the catheter 2 following the guide wire. As possible, the tip of the catheter may be more flexible than the guidewire.

Thus, in this embodiment, since the stylet wire 3 can maintain the bent state of the one end 2a side of the catheter 2 while the drug can be injected, the injection of the drug and the operation of the one end 2a of the catheter 2 can be performed. Can be performed without a time interval. For example, immediately after the contrast medium is released in the state of FIG. 3 (a) and the blood vessel is contrasted, the end 2a of the catheter 2 is placed at the branching point of the blood vessel, as shown in FIG. 3 (b). Can be inserted quickly.

The one end 3a of the stylet wire 3 may slightly protrude from the one end 2a of the catheter 2 as long as the one end 2a of the catheter 2 can be maintained in a bent state. One end 3 a of the wire 3 is accommodated in the catheter 2 without protruding from the one end 2 a of the catheter 2. In general, one end 3a of the stylet wire 3 is thinner and harder than the one end 2a of the catheter 2, and therefore has a sharp tip. Therefore, even with the same pressing force, the pressure per unit area applied to the body cavity is higher than that of the catheter 2. It will be high. Therefore, when the end 3a of the stylet wire 3 is accommodated in the catheter 2 without protruding, the possibility of damaging tissue in a body cavity such as an intima or inducing spasm is reduced. be able to.

When the one end 3a of the stylet wire 3 is not protruded from the one end 2a of the catheter 2 and the one end 2a side of the catheter 2 is maintained in a bent state, the positioning of the one end 3a of the stylet wire 3 in the axial direction is adjusted. May be. In this case, position adjusting means for adjusting the position of the one end 3a of the stylet wire 3 to a predetermined position on the one end 2a side of the catheter 2 may be provided. As the position adjustment means, for example, a plurality of length display portions such as scales and marks formed on the outer periphery of the hand side of the stylet wire 3 at predetermined intervals in the axial direction can be used. In this case, for example, according to the length of one end 3a of the stylet wire 3 protruding from the one end 2a of the catheter 2 as grasped by the contrast image, the stylet wire 3 is pulled toward the hand side by a predetermined number of scales. By operating, one end 3a of the stylet wire 3 can be adjusted to a predetermined position. As another mode of the position adjusting means, when the stylet wire 3 is inserted by a predetermined length, a part of the stylet wire 3 comes into contact and the insertion length of the stylet wire 3 is within a predetermined range. The stylet wire 3 or the catheter 2 may be provided with a restriction portion that is restricted by the above.

Next, using FIG. 4 to FIG. 7, a contrast system using a contrast medium as a medicine and comprising the medical device 1, the X-ray irradiation device (not shown), and the image display device (display) 6 described above. As an example, the operation of the medical device 1 of the present embodiment will be described. FIG. 4 shows, as a reference, a contrast image of the blood vessel when the contrast agent has spread throughout the blood vessel. In FIG. 4, reference symbol D indicates a target site where the one end 2 a of the catheter 2 is to reach.

As shown in FIG. 5, the catheter 2 inserted into the blood vessel V1 advances through the blood vessel V1 together with the stylet wire 3. In the blood vessel V1, the injection tool 4 is operated in a state where the one end 3a of the stylet wire 3 is positioned on the one end 2a side of the catheter 2 as shown in FIGS. The contrast agent supplied from the injection device 4 passes through the clearance between the inner surface of the catheter 2 and the stylet wire 3, and the one end 3 a of the stylet wire 3 is positioned on the one end 2 a side of the catheter 2. A contrast agent is released from one end 2 a of the catheter 2. At this time, pressure is applied to the insertion opening 52a side of the side branch 52 by the injection pressure of the contrast agent, but the backflow prevention valve 52b provided in the side branch 52 prevents the backflow of the contrast agent. Thereby, the contrast agent does not leak from the side of the insertion port 52a of the side branch 52, and the drug can be efficiently injected and released. When the contrast agent is strongly released, as shown in FIG. 5, the blood vessel V1 is imaged in real time from the periphery of one end 2a of the catheter 2 to its peripheral blood vessel (in FIG. 5 to FIG. The region of the blood vessel that can be visually recognized in the image display device 6 is indicated by a dot, and the portion that is not contrasted is indicated by a white area). When the branch blood vessel V2 in the advancing direction is imaged, the catheter 2 and the stylet wire 3 are advanced integrally while releasing the contrast agent weakly. As shown in FIG. 6a, when the one end 2a does not face the direction of the branch blood vessel V2, which is the traveling direction, the released contrast agent forms a laminar flow with blood coming from behind, and the branch blood vessel V2 is not imaged. Since contrast medium and blood have different specific gravity, they do not diffuse evenly and form a laminar flow. Since it can be seen that the catheter 2 does not advance into the branch blood vessel V2, the catheter 2 and the stylet wire 3 are rotated together while releasing the contrast medium weakly. Then, as shown in FIG. 6b, the branch blood vessel V2 is imaged by the laminar flow described above at the moment when it is directed to the blood vessel direction of the branch blood vessel V2. When the catheter 2 and the stylet wire 3 are integrally advanced while releasing the contrast agent at that timing, only the branch blood vessel V2 is imaged as shown in FIG. 6c. When the catheter 2 and the stylet wire 3 are integrally advanced at that timing, the blood vessel reaches the branch blood vessel V2 as shown in FIG. 6d. The catheter 2 and the stylet wire 3 are integrally advanced while rotating in the branch blood vessel V2 while releasing the contrast agent to reach the target site D. When passing through a branch with the branch blood vessel V3, the process proceeds as shown in FIG. 6e at a timing when the branch blood vessel V3 is not imaged. When passing through a branch with the branch blood vessel V4, the process proceeds as shown in FIG. Thus, when it is desired to image the entire peripheral blood vessel from the catheter 2, the contrast medium is strongly released. When the catheter 2 is advanced, when confirming the relationship between the blood vessel desired to be advanced by laminar flow or the blood vessel not desired to be advanced and the direction of the one end 2a, a necessary amount of contrast agent is released. As shown in FIG. 7, when the one end 2a of the catheter 2 reaches the target site D, the medicine is discharged, blood is sucked, etc., and a predetermined examination or treatment is performed. Thus, insertion of the catheter 2 is completed without removing the stylet wire 3.

As described above, the medical device 1 of the present embodiment can release the contrast agent in a necessary amount when necessary, is economical without wasteful release of the contrast agent, and is burdened by the patient. Can be reduced. Further, since it is not necessary to remove the stylet wire 3 each time the contrast agent is released, the end 2a of the catheter 2 can be advanced to the branch vessel immediately after the contrast agent is released. Therefore, the time required from the removal of the stylet wire 3 to the release of the contrast agent and the time required for reinsertion of the stylet wire 3 from the release of the contrast agent are reduced. In addition, it is easy to insert a blood vessel that branches in the X-ray incident direction, which is unknown in the map, with real-time contrast. Therefore, the burden on the patient due to the long-time treatment is reduced.

Further, according to the medical device 1 of the present embodiment, a real-time blood vessel map can be obtained by releasing a necessary amount of the contrast agent when necessary. With a method of advancing a stylet wire or catheter to a target blood vessel while viewing a fluoroscopic image of a catheter inserted into a body cavity while referring to a previously obtained angiographic image as a map, body movement, breathing, peristalsis, etc. Due to the influence, the difference between the previously obtained angiographic image and the fluoroscopic image of the catheter inserted into the body cavity may become large. On the other hand, a real-time blood vessel map is expected to be able to shorten the treatment time because it is hardly affected by body movement, breathing, or peristalsis.

The operation of the medical device 1 of the present embodiment has been described above by taking the release of the contrast agent from the distal end 2a of the catheter 2 as an example. However, not only the release of the drug but also the suction operation such as the suction of blood from the blood vessel. Have the same effect.

1 Medical device 2 Catheter 2a One end (tip) of catheter
2b The other end (base end) of the catheter
2c The lumen of the catheter 3 Stylet wire 3a One end (tip) of the stylet wire
DESCRIPTION OF SYMBOLS 4 Injection tool 4a Connection part 5 Catheter torquer hub with a side branch 51 Base part 51a One end of a base 51b The other end of a base 52 Side branch 52a Insertion port 52b Backflow prevention valve 6 Image display apparatus 7 Torque device C1 Catheter connection part C2 Injection tool connection part D Target site V1 Blood vessel V2 to V4 Branch blood vessel

Claims

A catheter inserted into the body cavity;
A stylet wire inserted into the catheter;
An injection device for injecting a drug into the catheter and releasing the drug from one end of the catheter that has entered the body cavity;
A catheter torquer hub having a linear base and a side branch communicating obliquely with respect to the base;
The other end of the catheter is connected to one end of the base, and the injection device is connected to the other end of the base,
The side branch has an insertion port into which the stylet wire is inserted on the other end side of the base,
The outer diameter of the stylet wire is smaller than the inner diameter of the catheter, and is a size capable of introducing the drug into one end side of the catheter,
With the stylet wire inserted into the catheter, the injection of the drug and the release of the drug from one end of the catheter into the body cavity are possible,
The said stylet wire is a medical device which can be maintained in the state which bent the one end side of the said catheter.
The medical device according to claim 1, wherein the drug is a contrast medium.
The medical device according to claim 1 or 2, wherein the side branch includes a backflow prevention valve for preventing backflow of the medicine.