JPH114893A - Hemostatic valve for catheter introducer - Google Patents

Abstract

(57) [Problem] To provide a hemostatic valve capable of reducing resistance at the time of insertion of a catheter and improving adhesion (air tightness) and hemostatic performance. SOLUTION: The hemostatic valve 1 is held in an introducer for introducing a catheter or the like into a blood vessel,
The non-clamping portion 3 is constituted by a thick non-clamping portion 3 and a thin clamping portion 2, and a slit 4 is formed in the non-clamping portion 3, extending outwardly from the center in a plurality of lines and penetrating from the top surface to the bottom surface. A hemostatic valve 1 for a catheter introducer in which a plurality of half slits 5, 5 a, 5 b or grooves extending from the bottom surface or the top surface of the holding portion 3 to the mid-abdomen are formed on the outer periphery of the slit 4.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an improved hemostatic valve for an introducer used when introducing a catheter or the like into a blood vessel.

[0002]

2. Description of the Related Art A catheter introducer is used to assist in safely and promptly inserting, removing, and exchanging a catheter used for performing a cardiac catheter test or the like. . Such an introducer incorporates a hemostatic valve at the base of the sheath, so that blood is not exposed even while the catheter or the like is introduced into the blood vessel through the sheath, and the operation of the catheter or the like can be performed smoothly. Is required. As the material of the hemostatic valve, silicone rubber is most suitable, and a relatively soft material is preferable. However, in the above materials, in order to have a shape that can withstand arterial pressure or the like, measures can be taken by simply increasing the thickness of the hemostatic valve or reducing the width of the slit. This will increase the resistance.

As a conventional hemostatic valve, a valve having a disk-shaped slit as a whole as shown in FIGS. 9 to 11 and FIGS. 12 to 13 is used. The hemostatic valve 51 of FIG. 9 forms two slits 54 that cross each other, and the hemostatic valve 61 of FIG.
4 and a groove 65 communicating with the center of the slit 64 is formed. These hemostatic valves 51 and 61 are shown in FIG.
As shown in FIG. 7, both ends are sandwiched and fixed between the introducer 77 and the cap 78 for use.

[0004] These hemostatic valves 51 and 61 are excellent in the initial operability at the time of insertion of the catheter. However, if the catheter is repeatedly inserted and removed, the closing function of the slits 54 and 64 is reduced, and the top surface is cracked. Occurs and the slits 54, 64
The blood spread and sometimes leaked. In order to solve such a problem, measures can be taken by increasing the wall thickness.However, if the wall thickness is increased while maintaining the shape of the conventional hemostatic valve, the clamping portion also becomes thicker, so that the entire body becomes harder and the slit is formed. Since the elongation of the catheter becomes poor, the operability at the time of inserting the catheter is significantly reduced. The inventors of the present invention have conducted intensive studies in order to solve the above problems, and as a result, have arrived at the next invention.

[0005]

SUMMARY OF THE INVENTION The present invention relates to a hemostatic valve 1 to be clamped in an introducer for introducing a catheter or the like into a blood vessel, comprising a thick non-clamping portion 3 and a thin clamping portion 2. A plurality of slits 4 extending from the center of the non-clamping portion 3 outward from the center thereof and penetrating from the top surface to the bottom surface, and extending from the bottom surface of the non-clamping portion 3 to the middle portion. The present invention provides a hemostatic valve 1 for a catheter introducer in which a half slit 5, 5a, 5b or a groove is formed on the outer periphery of the slit 4.

[0006]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIGS. 1 to 5 are schematic views showing one embodiment of the hemostasis valve of the present invention. 1 is an upper perspective view of the hemostatic valve 1, FIG. 2 is a lower perspective view of the hemostatic valve 1, FIG. 3 is a plan view of the hemostatic valve 1, FIG. FIG. The hemostatic valve 1 is made of a disc-shaped rubber elastic body (silicone rubber is most preferable), and is formed in a two-stage structure including a thin holding portion 2 and a thick non-holding portion 3. A concave portion 6 is formed at the center of the top surface of the holding portion 2.
Is formed with a plurality of slits 4 extending from the center in the outer peripheral direction and penetrating from the top surface to the bottom surface. Further, a plurality of linear half slits 5 extending from the bottom surface to the middle portion are formed in the holding portion 2 so as not to contact the slit 4 on the outer periphery of the slit 4.

The reason why the thick non-clamping portion 3 is formed in the hemostatic valve 1 is to improve the pressure resistance of the hemostatic valve. However, the resistance of the hemostatic valve tends to increase when a catheter or the like is inserted or removed. There is. However, by forming the half slit 5 on the outer periphery of the slit 4, it is possible to promote the elongation of the hemostatic valve at the time of insertion or withdrawal of the catheter or the like, thereby reducing the resistance and improving the pressure resistance without impairing the operability. Can be. Further, by forming the concave portion 6, the distal end portion of the catheter or the like can be easily inserted into the slit 4.

The half slit 5 formed in the hemostatic valve 1 of the present invention is not limited to the above-described shape, and may be, for example, a circumferential half slit 5a as shown in FIG. 6 or a circular half slit as shown in FIG. A half slit 5b combining a circumferential shape and a linear shape may be used. Also, the half slit 5,
Instead of 5a and 5b, a groove (of any shape) may be formed on the bottom surface. Although the half slits 5, 5a, 5b are formed from the bottom surface of the non-clamping portion 3 to the middle abdomen in FIGS. 1 to 7, they may be formed from the top surface of the non-clamping portion 3 to the middle abdomen. . Also, grooves (regardless of shape) may be formed on the top surface.

[0009]

FIG. 8 is a sectional view of the hemostatic valve 1 according to the present invention, which is clamped and fixed to an introducer 7. The clamping portion 2 of the hemostatic valve 1 is located between the end of the introducer 7 and the bottom tube of the cap 8. It is pinched. As shown in FIG. 8, the resistance value when inserting a 5 Fr angiographic catheter into the hemostatic valve 1 pinched and fixed, and the pressure resistance after 100 times of insertion and withdrawal were measured. In addition, a conventional hemostatic valve 5 was used as a comparison object.
In the same manner as in the hemostatic valve 1, the caps 1 and 61 were held between the introducers with the cap fixed thereto, and the resistance value and the pressure resistance were measured.
Table 1 shows the results.

[0010]

The hemostatic valve for a catheter introducer of the present invention can be used at the time of insertion or removal of a catheter by a half slit formed in a non-clamped portion even if the thickness is increased in order to improve pressure resistance. Since the extension of the hemostasis valve was promoted, the increase in the resistance value could be suppressed. By making the structure of the hemostatic valve a two-stage structure of the holding portion and the non-holding portion, the thickness of the valve was increased and the tightness (airtightness) was increased, so that the hemostatic performance could be improved. In addition, despite the increase in the thickness of the non-clamping portion, the thickness of the clamping portion is thinner than the conventional hemostasis valve, so the rubber tightening force is reduced,
Puncture resistance could be reduced.

[Brief description of the drawings]

FIG. 1 is an upper perspective view of a hemostatic valve of the present invention.

FIG. 2 is a lower perspective view of the hemostasis valve of the present invention.

FIG. 3 is a plan view of the hemostatic valve of the present invention.

FIG. 4 is a sectional view taken along line AA of FIG. 3;

FIG. 5 is a bottom view of the hemostasis valve of the present invention.

FIG. 6 is a lower perspective view showing another embodiment of the hemostasis valve of the present invention.

FIG. 7 is a lower perspective view showing another embodiment of the hemostatic valve of the present invention.

FIG. 8 is a cross-sectional view of the hemostatic valve of FIG. 1 clamped and fixed to an introducer.

FIG. 9 is a top perspective view of a conventional hemostasis valve.

FIG. 10 is a plan view of a conventional hemostasis valve.

FIG. 11 is a cross-sectional view of a conventional hemostasis valve.

FIG. 12 is a plan view of another conventional hemostasis valve.

FIG. 13 is a sectional view of another conventional hemostatic valve.

FIG. 14 is a cross-sectional view of a conventional hemostatic valve clamped and fixed to an introducer.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Hemostasis valve 2 Holding part 3 Non-holding part 4 Slit 5, 5a, 5b Half slit 6 Recess 7 Introducer 8 Cap

Claims (1)

[Claims] 1. A hemostatic valve 1 held in an introducer for introducing a catheter or the like into a blood vessel, comprising a thick non-holding portion 3 and a thin holding portion 2, wherein the non-holding portion is provided. 3, a plurality of half slits 5, 5a extending from the center of the non-clamping portion 3 to the middle portion of the non-clamping portion 3 are formed. A hemostatic valve 1 for a catheter introducer, wherein 5b or a groove is formed on the outer periphery of the slit 4.