JPH07155383A - Hemostatic valve for catheter introducer - Google Patents

Abstract

PURPOSE:To enhance a hemostatic property and to facilitate an operation to insert a tube for medical treatment by consisting of a hemostatic valve of a planar rubber- like elastic material which is provided with plural pieces of pleats extending radially from the center and is formed to a bellows shape, having a small hole at the center on the rear end side face of this material and forming plural pieces of slits extending radially to the opposite side face. CONSTITUTION:Silicone rubber for medical treatment consisting a dimethyl polysiloxane is used in terms of safety as the rubber-like elastic material constituting the hemostatic valve 3. The hemostatic valve 3 is formed by providing the valve with plural pieces of the pleats extending radially from the center to the bellows shape. The positions on the front side surface corresponding to the peak parts 6 of the rear end side face thereof are valley parts 7' and the positions on the front side face corresponding to the valley parts 7 of the rear end side face are peak parts 6'. The valve is provided with the small hole 4 having the diameter smaller than the diameter of the guide wire to be used and the depth of about half the thickness of the valve at the center of its rear end side face. On the other hand, plural pieces of the slits 5 extending radially in a radial direction from the center thereof are formed on the front side surface on the opposite side. The number thereof is specified to three pieces.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a hemostatic valve for a catheter introducer used when introducing medical tubing such as a catheter into a living body lumen, particularly into a blood vessel.

[0002]

2. Description of the Related Art For the purpose of diagnosis or treatment, for example, a blood vessel balloon catheter, an angiography catheter, or temperature, p
When introducing a catheter with a sensor for detecting H, oxygen, etc. into a blood vessel, extremely careful, safe and reliable treatment operation is required.

Usually, as a procedure for percutaneously introducing a blood vessel catheter into a blood vessel, first, a guide wire is inserted into the blood vessel by the Selsinger method, and then a catheter introducer combined with a dilator is guided along the guide wire. After the dilator and guide wire are removed, the tip of the introducer remains, and a catheter is inserted into the blood vessel along the guide of the introducer.

In this process, as shown in FIG. 2, a catheter (22) inserted into a blood vessel is introduced from a rear end opening (20) of an introducer through a sheath tube (21) provided on the distal side. Operate at hand (twist, push,
The introducer incorporates a hemostasis valve (3) in order to prevent the blood from leaking in the process of pulling it to the target site. And in this hemostasis valve,
It is required that the guide wire and the catheter are not sluggish during the operation, that blood does not leak even after they are pulled out, and that the operability of inserting the catheter is smooth.

On the other hand, the conventional hemostasis valve has a small hole (4) having a diameter slightly smaller than that of the guide wire on the rear end side (upper side of the drawing) as shown in FIG. In addition to preventing the blood from leaking out, a plurality of slits (5) are provided on the front side (the lower side in the figure) to prevent the blood from leaking when not inserted by the flap mechanism.

However, since these valves are flat, they are made of a rubber-like elastic material but have a limited elongation. For example, when using a guide wire of φ 0.9 mm, the diameter of the small hole (4) is made slightly smaller than that, and the small hole is forcibly expanded to a catheter diameter of φ 1.5 to 3 mm. Therefore, even if the slit (5) is provided, the insertion resistance is very large, which not only deteriorates the operability of the catheter, but also causes cracks around the small hole (4) particularly when a large-diameter catheter is inserted. It entered and caused the leakage of blood.

[0007]

SUMMARY OF THE INVENTION The present invention is intended to solve such problems of the conventional hemostasis valve for catheter introducer, and to insert a medical tube such as a catheter into a blood vessel. The purpose of the present invention is to provide a hemostasis valve for a catheter introducer that eliminates damage to the hemostasis valve at that time, reliably prevents blood leakage, and has excellent operability of a medical tube.

[0008]

That is, the present invention is a hemostasis valve disposed in an introducer for introducing a catheter into a living body lumen, which is provided with a plurality of folds extending radially from the center. It is made of a plate-like rubber elastic body formed in a bellows shape, has a small hole in the center of its rear end side surface, and has a plurality of slits radially extending from the center on the opposite front side surface. A hemostatic valve for a catheter introducer, which is characterized in that

A hemostatic valve for a catheter introducer according to an embodiment of the present invention will be described in detail below with reference to the drawings. 1A and 1B are views showing an embodiment of a hemostasis valve according to the present invention. FIG. 1A is a perspective view and FIG. 1B is a sectional view taken along line AA '.

As shown in FIG. 2, the hemostatic valve (3) according to the present invention is sandwiched between the main body portion (1) which constitutes the housing of the introducer and the cap portion (2) located on the rear end side. It is used by being fixed, and has a function of maintaining a liquid-sealed state with a guide tube or a medical tube such as a catheter that has been inserted. Silicone rubber is suitable as the material of the rubber-like elastic body forming the hemostasis valve, but medical safety silicone rubber made of dimethylpolysiloxane is particularly preferable from the viewpoint of safety.

As shown in FIG. 1 (a), a plurality of folds radially extending from the center are provided to form a bellows shape, and a mountain portion (upper side surface) on the rear end side surface (upper side surface in the figure) of the hemostasis valve. The position of the front side surface (lower surface side in the figure) corresponding to 6) is the valley portion (7 '),
Further, the position of the front side surface corresponding to the valley portion (7) of the rear end side surface is the mountain portion (6 '). Hemostasis valves commonly used for catheter introducers have a thickness of 1-2 mm,
The outer diameter is about 6 to 10 mm, but the number of folds (the number of peaks or valleys) in this case is appropriately 6 to 10. If the number of folds is larger than this, the folds are too close to each other, and if the number is smaller than this, the folds are close to a flat plate shape, and in any case, the effect of providing folds is not sufficient, which is not preferable.

Further, a small diameter (4) having a diameter smaller than the diameter of the guide wire used and a depth of about half the thickness of the valve is provided at the center of the rear end side surface. For example, for a generally used φ0.9 mm guide wire, it is desirable that the small hole (4) be approximately φ0.8 mm. On the other hand, a plurality of slits (5) extending radially from the center of the front side surface on the opposite side are formed. It is desirable that the number of slits (5) be three, because it is excellent in hemostasis and is not limited to this. The shape of the hemostasis valve (3) is usually disc-shaped, and the rear end side surface and the front side surface may be molded separately and laminated, but it is easier to assemble them if they are made as an integrally molded product, which is cost effective. Is also advantageous.

[0013]

The hemostatic valve (3) is connected to the catheter (2) from the rear open end (20) of the introducer as shown in FIG.
When it is inserted through 2), the slit (5) part is pushed open toward the front side to create a small gap, but the rubber-like elastic body of the hemostatic valve is in close contact with the catheter to prevent blood leakage. . At this time, since the hemostatic valve (3) has a bellows shape, there is a margin in the circumferential extension of the catheter, and the sliding resistance of the catheter (22) is not increased, so that smooth operation can be performed and the small hole (4) It is possible to prevent the valve from tearing because no excessive force is applied to the peripheral portion.

[0014]

As described above, the hemostatic valve for a catheter introducer according to the present invention has a bellows shape in the circumferential direction and has a good elongation, so that the hemostatic property is high and the insertion operation of the medical tube is smooth. And, since no unreasonable force is applied to the peripheral edge of the small hole in the center, no cracks occur,
By using this introducer, a medical tube such as a catheter can be inserted safely and reliably.

[Brief description of drawings]

FIG. 1 is a diagram showing a hemostatic valve for a catheter introducer according to an embodiment of the present invention, in which (a) is a perspective view and (b) is a sectional view taken along line AA ′ of (a).

FIG. 2 is a cross-sectional view showing a state in which a catheter is inserted through the introducer.

FIG. 3 is a view showing a conventional hemostasis valve, (a) is a perspective view,
(B) is a BB 'sectional view of (a).

[Explanation of symbols]

 1 Body part 2 Cap part 3 Hemostasis valve 4 Small hole 5 Slit 6,6 'Mountain part 7,7' Valley part 20 Rear opening end 21 Sheath tube 22 Catheter

Claims (2)

[Claims] 1. A hemostasis valve arranged in an introducer for introducing a catheter into a body lumen, comprising:
It consists of a plate-shaped rubber-like elastic body formed in a bellows shape with a plurality of folds extending radially from the center, and has a small hole in the center of its rear end side surface and a radial shape from the center on the opposite front side surface. A hemostasis valve for a catheter introducer, which is characterized in that a plurality of slits extending to the inside are formed. 2. The hemostasis valve for a catheter introducer according to claim 1, wherein the plate-like rubber-like elastic body is a laminate of a plurality of plate-like bodies.