JPH08103500A - Holder for removing fluid of catheter body, catheter medical treating device mounted therewith and its fluid removing method - Google Patents

Abstract

PURPOSE: To rapidly and easily remove the air, etc., in the hermetic part of a catheter body with a balloon with high operability and high accuracy and to enhance the safety of an operation. CONSTITUTION: The rear end of the catheter body 2 having the balloon at its front end and having the hermetic part including the balloon is mounted with a holder 6 integrally provided with a stop valve 3 for turning on/off the conduction with the hermetic part and a vessel mounting part 10 for mounting a vacuum vessel 5 holding negative pressure via this stop valve 3.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention quickly and easily removes internal air and the like from a catheter body with a balloon for dilating a blood vessel wall used in, for example, percutaneous coronary angioplasty (PTCA). The present invention relates to a holder for removing a fluid from a catheter, which can improve the safety of surgery, a catheter medical device to which the holder is attached, and a method for removing the fluid.

[0002]

2. Description of the Related Art In recent years, percutaneous coronary angioplasty (PTCA) has been widely used as a means for treating ischemic heart disease caused by narrowing of blood vessels such as coronary arteries.

This operation is performed, for example, as shown in FIG.
A so-called balloon-equipped catheter body a in which a balloon a2 is provided at the tip of a minute shut a1 having a diameter of about 1 to 5 mm is used. As well as insert
The balloon a2 is inflated by a liquid such as a contrast agent or a physiological saline solution injected from the rear end of the catheter body a to dilate the affected area and normalize the blood vessel.

In the expansion / shaping of the affected area, the balloon is left in the inflated state in the affected area for a while, or inflation / deflation of the balloon is repeated several times. The presence of air in the balloon means that the balloon is present. This will cause serious adverse effects for both the patient and the therapist, such as the risk of crack damage occurring in the skin, and confirmation of ensuring the normal shape of the balloon during contrast observation during treatment. Therefore, how to remove a small amount of air remaining in the catheter is important for improving the effectiveness and safety of this surgical procedure.

[0005]

However, there has been no established method for removing a trace amount of air in the past.
A commercially available syringe d is used, an adapter d1 at the tip thereof is connected to a connector a3 at the rear end of the catheter body a to fix them, and a small amount of air in the catheter is aspirated by pulling down the pusher d2 of the syringe. Is sucking.
This suction operation is repeated several times. After that, the injection barrel d is replaced with the contrast agent injector with the rear end closed by the cock e.

[0006] Therefore, in such a conventional device, there is a high risk of impairing the airtightness because it is necessary to attach and detach the injection cylinder a plurality of times and replace it with the contrast medium injector, and the catheter has a fine tube. Therefore, it is difficult to achieve satisfactory air removal even with advanced techniques. Further, this product is inferior in work efficiency, so that it takes a lot of time, and further, the accuracy of air removal is not constant depending on the operator, and thus there is a problem that it lacks reliability.

The present invention is based on connecting a vacuum container holding a negative pressure to the rear end of the catheter body.
An object of the present invention is to provide a holder for removing a fluid from a catheter body, a catheter medical device to which the holder is attached and a method for removing the fluid, which can solve the above problems.

[0008]

A first invention of the present application is a holder for removing a fluid in the sealing portion of a thin tubular catheter body having a balloon at the tip and having a sealing portion including the balloon, An on-off valve that is attached to the rear end portion of the catheter body and that turns on and off the connection with the sealing portion, and a container attachment portion to which a vacuum container holding negative pressure is attached are integrally provided via the on-off valve. It is a holder characterized by that.

A second invention of the present application comprises a thin tubular catheter body having a balloon at its tip and having a sealing portion containing the balloon, and a holder attached to the rear end of the catheter body, The holder is integrally provided with an opening / closing valve for connecting / disconnecting electrical connection with the sealing part and a container mounting part for mounting a vacuum container holding a negative pressure through the opening / closing valve. Is.

The opening / closing valve in the first and second inventions is preferably a three-way stopcock having one port communicating with the container mounting portion, and the other port is an injector for injecting liquid into the sealing portion. In addition to communicating with the injector mounting part to be mounted, the container mounting part and the injector mounting part may be exchanged with each other, and one port may be configured to communicate alternately with the container mounting part and the injector mounting part. . Further, it is preferable to attach a one-sided policy for breaking the vacuum vessel to the vessel attaching portion.

A third invention of the present application is a fluid removing method for removing the fluid inside a sealed portion of a thin tubular catheter body having a balloon at its tip by using a vacuum container holding a negative pressure.

[0012]

Since the container mounting portion is provided at the rear end of the catheter body via the on-off valve as described above, the vacuum container can be conveniently attached to and detached from the catheter body without impairing the airtightness, and the on-off valve By the switching operation, negative pressure can be quickly applied to the sealed portion of the catheter. Therefore, the air in the sealed portion can be removed with good operability and high precision, and the safety of surgery can be improved. Moreover, since a vacuum container is used, the accuracy of air removal is constant, and the accuracy of air removal can be set in advance according to the size of the vacuum container, the degree of negative pressure, the size of the catheter body, etc. Can be improved.

The on-off valve may be a two-way stopcock, but a three-way stopcock is preferable. By using the three-way stopcock, the removal of air in the sealed portion and the injection of the contrast agent or the like into the sealed portion can be switched with one touch, and the operability can be further improved. Even in the case of a three-way stopcock, it is not a problem in terms of operability to connect the vacuum container and the injector alternately by using only one port by making the container mounting part and the injector mounting part interchangeable as described above. Absent.

Further, the opening / closing valve and the container mounting portion are integrally formed on the holder so as to be more convenient to handle, and the container mounting portion is provided with a one-way policy for breaking the vacuum container. Negative pressure can be easily applied to the on-off valve at the same time when the vacuum container is attached.

[0015]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the holder and fluid removing method of the present invention will be described below with reference to the drawings together with a catheter medical device. As shown in FIG. 1, a catheter medical device 1 has a holder 6 attached to a rear end portion 2E of a catheter body 2 for detachably connecting a vacuum container 5.

As shown in FIG. 2, for example, the catheter body 2 is made of a flexible synthetic resin material and has a thin tubular shaft 11 having an outer diameter of, for example, about 1 to 5 mm, and is attached to the tip of the shaft 11. Balloon 12 that can be inflated and deflated
And a connector portion 13 provided at the rear end of the shaft 11, the shaft 11 includes an inner pipe 14 and the inner pipe 14.
Has a two-layer structure with the outer tube 15 which is fitted approximately concentrically, and the balloon 12 closes the upper end of the space 16 defined by the gap between the inner tube 14 and the outer tube 15.

The connector portion 13 is the shaft 1
1 and a first connector portion 13A which is substantially concentric with 1 and communicates with the central hole 14A of the inner pipe 14, and a second connector portion 13B which intersects with the first connector portion 13A at an acute angle and communicates with the space 16. Therefore, in the present embodiment, the space 16, the interior of the balloon 12 and the central hole (not shown) of the second connector portion 13B form the sealing portion 17 of the catheter body for filling the liquid B. As the liquid B, a water-soluble or oil-based contrast agent, physiological saline, or the like is used.
Further, the center hole 14A of the inner tube 14 is opened at the tip, and in this embodiment, a guide wire 19 for guiding a catheter passes through the center hole 14A and the center hole (not shown) of the first connector portion 13A. Configure a guideway.

The holder 6 is, as shown in FIG.
It comprises an on-off valve 3, an injector mounting part 9 for mounting an injector, and a container mounting part 10 for mounting a vacuum container.

The on-off valve 3 is, in this embodiment, the first, second,
A T-shaped three-way stopcock having third ports 3A, 3B, 3C and selecting and closing one of the ports 3A, 3B, 3C by switching operation to the lever 20. The second connector 13B is fixed to 3A via a connector 16 such as a nut fitting.

The three-way stopcock has a cylindrical rotary valve body 50 which is rotated by a lever 20, as schematically shown in FIGS. A communication hole 51 intersecting with a T shape is formed. Therefore, in this example, the port facing the lever 20 is closed and the remaining ports are connected. Further, in this example, the ports that face each other in a straight line are called first and third ports 3A and 3C, and the ports that face at right angles to them are called second ports 3B.

The second and third ports 3B and 3C respectively communicate with the container mounting portion 10 and the injector mounting portion 9 in this example.

As shown in the enlarged view of FIG. 4, the container mounting portion 10 has a connecting piece 2 connected to the second port 3B.
2 and a holding piece 23 attached to the connecting piece 22.

The connecting piece 22 has a tapered cone-shaped body portion 22A which is fitted and mounted in the port 3B, for example.
A bottomed hole portion 22C is opened at the tip of the body portion 22A, and a screw portion 22B is projected at the rear end. Further, an injection needle-shaped piece guide 24 that projects rearward from the screw portion 22B is embedded in the connection piece 22, and the needle hole 24A thereof is electrically connected to the inside of the hole portion 22C.

The holding piece 23 has a cylindrical main portion 23B having an open rear end having a screwing portion 23A screwed to the screw portion 22B at the tip thereof, and the inner wall of the main portion 23B is the vacuum container 5.
Then, the vacuum container 5 is detachably attached by, for example, fitting through the rib R. A step H for positioning that abuts on the front end of the vacuum container 5 is formed on the inner wall of the main portion 23B, and the one-direction guide 24 extends rearward beyond the step H.

The vacuum container 5 is, for example, a sealed container in which the front end opening of a test tube-shaped container substrate 26 is closed by a lid 27, and in this embodiment, a negative pressure of, for example, 150 mmHg or less is maintained.

The lid 27 is a pierceable thin film made of metal, synthetic resin or the like, and a flat needle hole sealing piece 29 made of a rubber material is attached to the center of the outer surface of the lid 27. . Therefore, when the vacuum container 5 is fitted into the holding piece 23, the needle tip of the piece guide 24 pierces the lid 27 together with the needle hole sealing piece 29 so as to be electrically connected to the inside of the vacuum container 5. A negative pressure is applied to the second port 3B. The needle hole sealing piece 29 prevents leakage of negative pressure between the needle hole sealing piece 24 and airtightly seals the trace of breakage of the lid 27 when the vacuum container 5 is removed.

As the vacuum container 5, the lid 27 may be formed in the shape of a rubber plug, as shown schematically in FIG. 7, and at this time, the lid 27 is made thin so that its center can be pierced. To do.

In the present embodiment, the one-sided guide 24 is always covered and protected by a bag-shaped cover body 30 made of a rubber material which is locked by a constricted portion 25 provided at the rear end of the screw portion 22B. It The cover body 30 normally seals the conduction of the needle hole 24A in the container mounting portion 10, and at the time of mounting the vacuum container 5, the one-way needle 24 penetrates the cover body 30 to remove the needle tip. Open. Therefore, the cover body 30 cooperates with the one-sided policy 24 and can also function as an on-off valve that connects and disconnects the electrical connection between the vacuum container 5 and the sealing portion 17.

Further, in the present embodiment, the injector mounting portion 9 is
A connector 31 that is directly formed at the tip of the third port 3C and has, for example, a connector 31 having substantially the same configuration as the connector 18.
The injector 4 can be attached by using. The injector 4 can also be connected by simple fitting or the like.

In this embodiment, the injector 4 is a liquid pressure injector called a so-called indeflator, and is a cylinder 3 having an injection cylinder shape having an inner hole 35A for accommodating the liquid B.
5, and a presser foot 3 for pressing the liquid B in the inner hole 35A
6 and a pressure gauge 37 for displaying the internal pressure of the cylinder 35. Further, the pressure pusher 36 can be screwed back and forth by the screw hole 35B provided at the rear end of the cylinder 35, and the liquid B can be injected under pressure while finely adjusting the pressure. The cylinder 3
At the front end of 5, there is provided a conducting tube 38 which is connected to the injector mounting portion 9 and electrically connects the third port 3C and the inner hole 35A.

Next, an example of a method for operating the catheter medical device 1 of the present application will be described. A holder 6 formed by integrally assembling the on-off valve 3, the injector mounting portion 9, and the container mounting portion 10 is formed in advance, and the first port 3A of the holder 6 is connected to the second connector portion 13B by the connecting tool 16. The catheter medical instrument 1 having the holder 6 attached to the rear end portion 2E of the catheter body 2 is assembled by fixing the catheter medical instrument 1 through the above. At this time, the lever 20 of the opening / closing valve 3 is held in the direction in which the second port 3B is closed.

Next, the vacuum container 5 is fitted and mounted in the container mounting portion 10 of the holder 6. At the same time as this mounting, the one-sided policy 24 of the container mounting portion 10 is
Also, the lid 27 is pierced together with the needle hole sealing piece 29 and is electrically connected to the inside of the vacuum container 5, thereby applying a negative pressure to the second port 3B.

Next, by operating the lever 20,
The closed state is gradually switched from the second port 3B to the third port 3C, and the sealing portion 17 is gradually shifted to the negative pressure state. Although it is possible to apply negative pressure rapidly, the normal balloon 12 is compactly folded into two or more around the inner tube 14 as shown in FIG. May cause air to remain in the folded portion 12A, so it is judged that it is preferable to gradually apply a negative pressure.

The capacity of the sealing portion 17 is generally 2.5 to
By using the vacuum container 5 having a capacity of about 3.5 cc, for example, about 5 to 10 cc, and a negative pressure state of about 50 to 150 mmHg, the air in the sealing portion 17 can be removed with high accuracy. Further, as described above, the container mounting portion 10 can exert the valve function by the one-direction guide 24 and the cover 30, so that the vacuum container 5 can be easily replaced while maintaining the airtightness, and the air can be removed with higher precision. become.

Next, as shown in FIG. 1, the catheter body 2 in which the sealing portion 17 is kept in a negative pressure state is inserted into, for example, a sheath 40 for securing a blood vessel and guiding for guiding the catheter body 2. The blood vessel b is inserted into the affected area c where the blood vessel b is narrowed through the catheter 42, and then the injector 4 is securely fixed to the injector attachment portion 9 at the tip of the third port 3C via the connector 31. At this time, in order to prevent air from entering between the conduit tube 38 and the port 3C, the port 3
It is preferable to connect the liquid C up to the tip of the liquid C when it is sufficiently filled. Further, when air is mixed, it is necessary to hold the rear end of the injector 4 upward and separate the mixed air from the injection port.

Next, by operating the lever 20,
The closed state is switched from the third port 3C to the second port 3B, and the fluid B is introduced into the sealed portion 17 by the screwing operation of the presser foot 36 combined with the automatic suction by the negative pressure in the sealed portion 17.
The balloon 12 can be inflated into a predetermined shape with almost no bubbles mixed therein. As the on-off valve 3,
Two two-way stopcocks may be used in combination, and in this example, since the one-way guide 24 and the cover 30 have a valve function, the on-off valve 3 can be replaced with a two-way stopcock.

Another example of the method of operating the catheter medical device 1 will be described. As shown in FIGS. 9 (A) to 9 (C), the container mounting portion 10 is, for example, fitted into the third port 3C to assemble the mounting holder 6, and the first port 3A is fixed to the connector portion 13B. . At this time, the connector portion 13B and the holder 6 are connected in a straight line, and the operability is enhanced.

The third port 3C operated by lever operation
In the closed state, the vacuum container 5 is attached to the container attachment portion 10 to apply a negative pressure to the third port 3C. Further, in order to reliably prevent the leakage from the second port 3B, after sealing the port 3B with the lid 52, the air in the sealing portion 17 is discharged by the communication between the ports 3A and 3C by the operation of the lever 20. To do. In addition, the container mounting part 1
Since the needle hole 24A of the one-point guide 24 of 0 has a small diameter, the negative pressure load on the sealing portion 17 is gradually performed.

Next, the first port 3A by the lever 20
The holder 6 is removed from the third port 3C in a state where the sealing portion 17 is kept at a negative pressure by the closing of the above, and then the injector 4 is attached to the third port 3C.
After removing the lid 52, the liquid B is pushed out of the injector 4 and filled with the fluid B in the on-off valve 3 until the fluid B flows out from the second port 3B. Is surely discharged.

The lever 20 allows the second port 3B
Then, the balloon 12 is inflated into a predetermined shape by further extruding the liquid B from the injector 4.

Therefore, in this example, the third port 3C is
It functions as a connecting portion for connecting the container mounting portion 10 and the injector mounting portion 9, and alternately connects the vacuum container 5 and the injector 4.
In addition, the second port 3B functions as a drain of the fluid B, and prevents air from remaining in the on-off valve 3.

Further, FIG. 8 discloses another embodiment of the holder 6. In the figure, the holder 6 has a plurality of container mounting portions 10 formed on the second port 3B or the third port 3C of the on-off valve 3 via the collecting pipe 41. The collecting pipe 4
1 includes, for example, three connector portions 41C for connecting the connecting portion 41B connected to the port and the connecting piece 22 of the container mounting portion 10 to the collecting pipe base portion 41A, and each connector portion 4
1C and the connecting portion 41B communicate with each other. Therefore, when a higher degree of air removal is required, and when the catheter body 2 having a large capacity of the sealing portion 17 is used, a great effect can be exhibited. An on / off valve may be attached to each connector portion 41C.

Such a catheter medical device has the above-mentioned PT
It can be used for treatment of various vascular stenosis including cerebral blood vessels in addition to coronary vascular stenosis such as CA, and the volume, negative pressure and number of attached vacuum vessels can be freely set according to the type of treatment. You can.

[0044]

Since the present invention is constructed as described above, air and the like in the sealed portion of the catheter body can be removed quickly, with high operability, easily and with high precision, and
The safety of surgery can be improved.

[Brief description of drawings]

FIG. 1 is a schematic diagram showing a usage state of an embodiment of a catheter medical device of the present invention.

FIG. 2 is a cross-sectional view showing an example of a catheter body.

FIG. 3 is a cross-sectional view showing an example of a holder.

FIG. 4 is a sectional view showing an example of a container mounting portion.

FIG. 5 is a cross-sectional view showing a folded state of the balloon.

6 (A), (B) and (C) are sectional views schematically showing an example of an on-off valve.

FIG. 7 is a schematic cross-sectional view showing another example of a vacuum container.

FIG. 8 is a sectional view showing another embodiment of the holder.

9 (A), (B), and (C) are diagrams for explaining another operation method of the catheter medical device.

FIG. 10 is a schematic diagram illustrating a conventional technique.

[Explanation of symbols]

 2 Catheter body 2E Rear end 3 On-off valve 3A, 3B, 3C Port 4 Injector 5 Vacuum container 6 Holder 9 Injector mounting part 10 Container mounting part 12 Balloon 17 Sealing part 24 One-sided policy

Claims (7)

[Claims] 1. A holder for removing fluid in the sealed portion of a thin tubular catheter body having a balloon at the tip and having a sealed portion including the balloon, the holder being attached to the rear end of the catheter body, A holder for fluid removal of a catheter main body, which is integrally provided with an opening / closing valve for connecting / disconnecting electrical connection with the sealing portion and a container mounting portion for mounting a vacuum container holding a negative pressure via the opening / closing valve. 2. The on-off valve is a three-way stopcock having one port communicating with the container mounting portion.
A holder for removing fluid from the catheter body described. 3. The holder for removing a fluid from a catheter body according to claim 1, wherein the container mounting portion is provided with a piece of policy for breaking through the vacuum container. 4. A thin tubular catheter body having a balloon at its tip and having a sealing portion containing the balloon, and a holder attached to the rear end portion of the catheter body, the holder including the sealing portion. An on-off valve that connects and disconnects the connection between the on-off valve and a container attachment part to which a vacuum container holding a negative pressure is attached via the on-off valve. 5. The on-off valve is a three-way stopcock with one port communicating with the container mounting portion.
The described catheter medical device. 6. The catheter medical device according to claim 4, wherein the container mounting portion is provided with a piece of policy for breaking through the vacuum container. 7. A fluid removing method for removing the fluid inside the sealed portion of a thin tubular catheter body having a balloon at the tip and having a sealed portion including the balloon, by using a vacuum container holding a negative pressure.