JP3618029B2 - Hemostasis valve for catheter introducers - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a hemostasis 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]
[Prior art]
For the purpose of diagnosis and treatment, for example, vascular balloon catheters, angiographic catheters, or catheters with sensors that detect temperature, pH, oxygen, etc. are introduced into blood vessels, requiring extremely careful, safe, and reliable treatment operations. Is done.
Normally, the procedure for percutaneously introducing a vascular catheter into a blood vessel is to first insert a guide wire into the blood vessel by the Seldinger method, and then insert a catheter introducer combined with a dilator into the blood vessel along the guide wire. And then the dilator and guide wire are removed to leave the introducer tip, and the catheter is intubated into the blood vessel along the introducer's guidance.
[0003]
In this process, as shown in FIG. 2, the catheter (12) inserted into the blood vessel through the sheath tube (11) provided on the distal end side from the rear part of the introducer is operated (twisted, pushed, pulled) at hand. In order to prevent blood from leaking in the process, a hemostasis valve (3) is incorporated in the introducer. The hemostasis valve is required not only during the operation of the guide wire and the catheter but also after the withdrawal of the guide wire and the catheter, and that the insertion operation of the catheter is smooth.
[0004]
Conventional hemostasis valve contrast, has a rear end (figure reverse side) to guide slightly larger than the wire diameter of the small hole (4) as shown in Figure 3, guide wire or upon insertion of a catheter for blood In addition to preventing leakage, a plurality of slits (5) are provided on the front side (the front side of the figure), and the flap mechanism prevents blood leakage when not inserted.
[0005]
There are two processing methods for providing these three or more slits (5): post-processing with a punching blade or valve body (3) with a blade provided in advance in the mold (3). Each processing method has the following problems. Needless to say, the above-described processing with the punching blade is costly for post-processing, and a slight crack is likely to occur at the tip of each slit (5), and repeated insertion and extraction operations of the catheter (12) are performed. Cracks grew and the hemostatic valve body was often damaged leading to blood leaks. In addition, in the processing method using the mold described later, a gap (width) is generated in the slit (5) corresponding to the thickness of the mold blade, and the arterial pressure in the case of use in indwelling the artery due to its incorporation into the introducer. In some cases, however, the flap mechanism works to prevent blood leakage, but in the case of a slight pressure during indwelling of the vein, the flap mechanism does not work and blood leaks from the gap of the slit (5).
[0006]
[Problems to be solved by the invention]
An object of the present invention is to eliminate such problems in the past, and eliminates damage to the hemostasis valve when a medical tube such as a catheter is inserted into a blood vessel, thereby reliably preventing blood leakage. At the same time, it is intended to provide a hemostasis valve for a catheter introducer that is low in cost.
[0007]
[Means for Solving the Problems]
That is, the present invention comprises a plate-like rubber elastic body, has a small hole in the center of the rear side surface, and has three or more slits extending radially from the center on the opposite front side surface. The hemostasis valve for a catheter introducer is characterized in that the radius between adjacent slits, that is, the radius of the slit non-installed portion is longer than the radius on the extension line of the slit when the hemostasis valve is viewed from above.
[0008]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, a hemostasis valve for a catheter introducer according to an embodiment of the present invention will be described in detail with reference to the drawings. 1A and 1B are views showing an embodiment of a hemostasis valve according to the present invention, in which FIG. 1A is a top view and FIG.
As shown in FIG. 2, the hemostasis valve according to the present invention is used by being gripped and fixed between the body part (1) constituting the introducer housing and the cap part (2) located on the rear end side thereof, It functions to maintain a liquid-sealed state with a medical tube such as the inserted catheter (12) and a guide wire. Silicone rubber is suitable as the material for the rubber-like elastic body constituting the hemostasis valve (3), but it is particularly preferable to use medical silicone rubber made of dimethylpolysiloxane from the viewpoint of safety.
[0009]
As shown in FIG. 1 (a), a small hole (4) having a diameter smaller than the diameter of the guide wire used and about half the thickness of the valve is provided at the center on the rear end side. Yes. For example, for a generally used guide wire of φ0.9 mm, the small hole (4) is preferably about φ0.8 mm. On the other hand, three or more slits (5) extending in the radial direction from the center are formed on the front side surface on the opposite side. The number of slits (5) is preferably 3 because it is excellent in hemostasis and is not limited to this.
[0010]
When the hemostatic valve (3) body is viewed from above, the radius R between the slits (5) is longer than the radius r on the extension line of the slit (5), and the body part (1) of the introducer When incorporated in the hemostasis valve insertion portion having a circular shape, the width t of the slit (5) is closed. The radii R and r are the difference between the width t of the slit (5) and the length of 0.5 mm or less. If there is no difference from the width t of the slit (5), the slit (5) cannot be closed sufficiently, and if the dimension is 0.5 mm or more, the force to close the slit (5) becomes too strong and hemostasis is caused. Although effective, there is a problem that the operability of the catheter (12) is poor.
[0011]
Although the hemostasis valve (3) is made by compression molding, the slit (5) and the small hole (4) are also molded at the same time, so that a minute crack due to a punching blade or the like does not occur at the tip of the slit (5). It can also be created without post-processing.
[0012]
【The invention's effect】
As described above, the hemostasis valve for a catheter introducer according to the present invention has a high hemostasis property because it is closed by being incorporated into the introducer, and can be molded without post-processing, so that the slit tip is cracked at a low cost. It does not occur, and by using this introducer, a medical tube such as a catheter can be inserted safely and reliably.
[Brief description of the drawings]
1A and 1B are views showing a hemostasis valve for a catheter introducer according to an embodiment of the present invention, in which FIG. 1A is a top view and FIG. 1B is a cross-sectional view taken along line AA ′ of FIG.
FIG. 2 is a cross-sectional view showing a state where a catheter is inserted through an introducer.
FIG. 3 is a top view showing a conventional hemostasis valve.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Main body part 2 Cap part 3 Hemostatic valve 4 Small hole 5 Slit 11 Sheath tube 12 Catheter

Claims (3)

A hemostasis valve disposed in an introducer for introducing a catheter into a living body lumen, which is made of a plate-like rubber elastic body and has a small hole in the center of its rear side surface, and on the opposite front side surface Three or more slits extending radially from the center thereof are formed, and when the hemostasis valve is viewed from above, the radius between the adjacent slits, that is, the radius of the slit non-installed portion, relative to the radius on the extension line of the slit. A hemostasis valve for a catheter introducer characterized in that is longer. The hemostasis valve for a catheter introducer according to claim 1, wherein the difference (R-r) between the radius (r) on the extension line of the slit and the radius (R) of the non-slit portion is not less than the slit width and not more than 0.5 mm. The hemostasis valve for a catheter introducer according to claim 1 or 2, which is prepared by a processing method in which a blade for slitting is provided in advance in a compression molding die and a slit is formed simultaneously with molding.

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