JPH0639011U - Hemostasis valve - Google Patents

Abstract

(57) [Summary] [Purpose] To provide a hemostasis valve that prevents blood leakage and reduces the resistance when a catheter passes through a valve to improve operability. [Structure] FIG. 3 is a cross-sectional perspective view of a hemostatic valve 2, which has a mortar-shaped recess 8 on its surface, and has a concentric groove at least near its center, and this groove has a crown-shaped shape. It runs through the groove 12. In addition, a slit 11 is provided on the back surface side of the hemostasis valve 2, and three directions 11a, 11b, and 11c are provided at equal angles from the center of the hemostasis valve 2. The length from the center of the slit 11 is preferably equal to or shorter than the length from the center of the mortar-shaped recess. Further, the hemostatic valve 2 has a film 10 between the bottom of the impermeable hole 9 and the slit 11, and the thickness of the film 10 is 5% to 20% of the thickness of the hemostatic valve 2, preferably. Is 8
% To 12%, and more preferably around 10%.

Description

[Detailed description of the device]

[0001]

[Industrial applications]

 The present invention relates to a hemostasis valve used in a sheath introducer, etc., and more particularly, to prevent leakage of blood, particularly during operation, leakage during replacement of deformed catheters, etc., or deterioration of operability accompanying it. The hemostasis valve that was done.

[0002]

[Prior art]

 Angiography is a method of diagnosing and treating the condition of the affected area by passing a guide wire through the blood vessel, guiding the catheter to the affected area using this as a guide, and ejecting a contrast agent to perform X-ray photography. Conventionally, when doing this, for example, a sheath introducer is inserted into a blood vessel, and a guide wire or a catheter is inserted into the blood vessel via this.

As shown in FIG. 4, this sheath introducer is provided with a hemostatic valve 2 between the upper portion of the housing 4 and the cap 3 so that blood fluid will leak during operation. Is being prevented.

Conventionally, such a hemostasis valve has been known, and for example, a type and an actual type in which a valve membrane having a through hole in the center and a valve membrane having a slit are stacked to prevent blood leakage. As described in Kaihei 1-87746, a mortar-shaped cut portion is provided on one side, a small hole is bored in the center, and a slit is cut in the back side so as to pass through the center of the small hole. The valve body provided is shown as an example.

[0005]

[Problems to be solved by the device]

 However, in the type in which the valve leaflets are stacked, different materials can be used, so it is possible to prevent desired blood leakage, but since a synthetic plastic resin is used, a guide wire with a small diameter can be used. Although it does not leak, there is a problem in operability, such as a sticking phenomenon when using a large-diameter catheter, which makes insertion difficult.

The valvular body described in Japanese Utility Model Laid-Open No. 1-87746 discloses a single layer for blood leakage, which is preferable. In the case, the catheter and valve are hardened and abdominal movement is caused, and the operability of the catheter is significantly reduced. Also, when using a thick catheter and then replacing it with a thin catheter, there was another problem that it was not enough to prevent blood leakage.

In view of the above-mentioned problems, the present inventor has further studied the problems of the valvular body, that is, the hemostasis valve, and has been able to solve the following problems. The present invention has been achieved here. (1) The structure and material should be such that the positive pressure from the patient and the positive pressure and negative pressure when operating the side arm are sufficiently sealed even when the wire or catheter is not inserted into the introducer.

(2) When a wire or a catheter is inserted in the introducer, positive pressure from the patient and positive pressure and negative pressure when operating the side arm are sufficiently endured, and positive flushing pressure is applied. At the time, the structure and material should be self-sealing.

(3) Structure and material that can keep the self-sealing against insertion of the catheter into the introducer, long-term use, replacement of deformed size of the catheter, linear reciprocating motion of the catheter, and rotational twisting motion To be.

(4) A structure and a material that do not cause sticking or abdominal movement between the catheter and the valve during catheter operation and do not reduce the operability of the catheter over time. Therefore, the purpose of the present invention is to prevent the leakage of blood from the valve and the leakage of blood from the valve when the catheter of a different size is used in alternation, and to reduce the resistance when the catheter passes through the valve. It is to provide a hemostatic valve with improved sex.

[0011]

Means for Solving the Problems The above object of the present invention is a disk-shaped body made of a thermosetting resin having elasticity, and one surface side of the disk-shaped body has a mortar shape at the center thereof. Has a recessed portion, and has a non-permeable hole in the center of the recessed portion, the other surface side is provided with a slit having a desired thickness from the surface toward the center, and the slit is formed in the circle. This is achieved by a hemostasis valve, which is provided at equal angles in multiple directions from the center of the plate-shaped body.

Further, the present invention can be achieved by a structure in which the hemostatic valve has concentric grooves at least near a center of a surface of a mortar-shaped recess. Further, the present invention is achieved by the above-described hemostasis valve, which has a hole at the center of an impervious hole provided in a mortar-shaped recess.

[0013]

[Action]

 In the present invention, (1) By using a thermosetting resin having elasticity as a material of the hemostatic valve, when a catheter or the like is pulled, it is restored when it is released, and when compressed, it is restored when it is released. Acts to return. Also, if you insert a slightly larger valve into a tube with a limited diameter, the force will be compressed toward the center, so if you insert the catheter tube here and open the insertion part, try to compress the catheter tube. Force acts, thus acting as a self-sealing force on the catheter tube.

Further, the film between the bottom portion of the impermeable hole and the slit acts so as to be easily torn when a wire or the like is inserted.

(2) By having concentric grooves at least near the center of the surface of the mortar-shaped recess, the grooves shrink when the catheter tube passes through the mortar-shaped recess when inserting a catheter tube or the like. This causes a phenomenon that the contact between the tube and the valve is not a surface contact but a point contact, which acts to minimize the contact area. This has the effect of introducing the catheter tube very easily.

(3) Since there is a film between the bottom part of the impermeable hole and the slit, even when a thin wire is used, this film adheres to the peripheral wall of the wire to prevent blood leakage. Have.

[0017]

【Example】

 Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited to these examples. 1 is a cross-sectional view showing a hemostatic valve 2 of the present invention, FIG. 2 is a plan view showing the back surface of the hemostatic valve 2 of the present invention, and FIG. 3 is a dashed-dotted line C-D of FIG. FIG. 6 is a cross-sectional view showing a portion cut by.

The hemostatic valve 2 is made of thermosetting silicone rubber. The thermosetting resin preferably has a hardness of 35A to 50A (JIS-A is KN / mckg / cm). More preferably, it is around 40A. Further, the tear strength is required to be 20 JIS-A or more, and after passing through the catheter due to the interaction with the elongation rate, along the slits in the impermeable holes 9, the slit tearing strength is required not to be performed.

Further, the elongation rate is required to be 400% or more, and the impervious hole 9 has an elongation rate which spreads when the catheter tube is inserted but does not tear. Further, the impact resilience is preferably around 260, and after the catheter tube or guide wire is inserted and pulled out by the force of this impact resilience, sealing can be performed by utilizing the return elasticity.

In the present invention, the thermosetting silicone rubber is used to provide appropriate elasticity, impact resilience, adhesion, etc., so that when used as a valve, leakage of blood fluid is prevented. It also prevents operability and improves the operability of wires and catheter tubes.

On one surface side of the hemostatic valve 2, that is, on the surface side, a mortar-shaped recess 8 is provided in the center thereof, and an impermeable hole 9 is further provided in the center of the recess. The diameter of the impermeable hole 9 is preferably 0.50 to 0.80 mm.

The mortar-shaped concave portion 8 has a depth of 0.2 to 0.3 mm, and has a crown shape having a groove therein. As a result, when inserting a catheter tube or the like, when the catheter tube passes through the mortar-shaped recess, the groove causes a contraction phenomenon, and the contact between the tube and the valve becomes point contact instead of surface contact, so that the contact area is as large as possible. Acts to reduce.

The mortar-shaped recess 8 shown in FIG. 1A preferably has a concentric groove at least near the center of its surface, as shown in FIG. 1B. Etc. can be easily inserted without resistance. Further, this groove is preferably a crown-shaped groove.

A slit 11 is provided on the back surface side of the hemostasis valve 2, and as shown in FIG. 3, three directions 11a, 11b, and 11c are provided at equal angles from the center of the hemostasis valve 2. Has been. The length from the center of the slit 11 is preferably equal to or shorter than the length from the center of the mortar-shaped recess.

The slit portion is such that expansion along the slit 11 is performed in accordance with the diameter of the catheter tube, and an action of restoring the sealing speed of the valve is produced. Further, the hemostatic valve 2 has a film 10 between the bottom of the impermeable hole 9 and the slit 11, and the thickness of the film 10 is 5% to 20% of the thickness of the hemostatic valve 2. It is preferably 8% to 12%, more preferably around 10%.

In the conventional valve, a wire having a diameter larger than the central pore diameter of the valve is mainly used. In such a case, the elasticity of the central pore diameter causes the wire peripheral wall to come into close contact with the wire. Although this does not occur, it is still present when using a wire with a diameter smaller than the pore size of this valve. In such a case, the conventional valve creates a small space, from which blood leaks. In order to prevent this, the valve 10 is provided so that various wires or catheter tubes can be used.

The depth of the mortar-shaped recess 8 with respect to the thickness of the hemostatic valve 2, the depth of the impermeable hole 9, and the total thickness of the membrane 10 and the slit 11 are determined in consideration of the type and structure of the resin. The depth of the mortar-shaped recess 8 is preferably 20% to 30%, the depth of the impermeable holes 9 is 25% to 40%, and the total thickness of the film 10 and the slit 11 is appropriately determined. Are 35% to 45%, and more preferably 25%, 35%, and 40%, respectively.

FIG. 1 shows a groove having a crown shape as the shape of the mortar-shaped recessed portion 8. However, in addition to this, the shape shown in FIG. 6 may be used. That is, a in FIG. 6 is formed in a spiral shape, and b in FIG. 6 has grooves at equal intervals. Further, as shown in FIG. 6c, it may have a convex shape in which the thickness is partially increased radially. 6d shows a partial cross-sectional view of the hemostatic valve 2 of FIG. 6c.

In FIG. 2, the hemostatic valve 2 of the present invention has a perforation 13 at the center thereof so that the membrane 10 can be cut along the slit 11 in the impermeable hole 9 using the perforation 13 as a guide hole. I am Next, the use state of the hemostatic valve 2 of the present invention is shown in FIG. 5, which is a plan view of the hemostatic valve 2 of the present invention seen from the front side, and FIG. 5b shows the state in which the catheter tube or the dilator tube 14 is inserted. Further, FIG. 5C shows a state after the procedure is completed, and in this state, the film 10 of the slits 11a, 11b, and 11c is broken in the impermeable hole 9 (shown by a solid line).

In this way, when the catheter tube or the like is pulled out, the state is as shown in FIG. 5C, and when the catheter operation is completed, the state immediately returns to the state as shown in FIG. 5C to prevent blood leakage. In addition, the valve during catheter operation is in close contact with the catheter wall without any gap, resulting in the state shown in Fig. 5b, and even if in close contact there is slippage, which does not give resistance to catheter operation and is good. Can be operated.

On the other hand, in the case of a rubber-elastic hemostasis valve (for example, silicone rubber) that has been conventionally used even if it has an elongation of 400%, a gap is created between the valve and the catheter, Blood leaks from here, so it cannot be prevented.

[0032]

[Effect of device]

 Since the present invention has the above-mentioned configuration, during diagnosis or treatment by angiography, blood leakage from the valve is prevented during operation of the catheter or after the operation, and when the catheter passes through the valve. The resistance of the catheter can be reduced and the operation of the catheter, etc. can be performed well.

[Brief description of drawings]

FIG. 1 is a cross-sectional view showing a hemostasis valve of the present invention.

FIG. 2 is a plan view showing the back surface of the hemostatic valve of the present invention.

FIG. 3 is a sectional perspective view showing a hemostatic valve of the present invention taken along line C-D.

FIG. 4 is a schematic sectional view showing a sheath introducer in which the hemostatic valve of the present invention is combined.

FIG. 5 is a cross-sectional view showing a state of use of the hemostatic valve of the present invention, where a is before use, b is during use, and c is after use.

6A, 6B and 6C are plan views showing another hemostatic valve of the present invention, and d is a sectional view of c.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 Sheath 8 Mortar-shaped recess 2 Hemostasis valve 9 Impermeable hole 3 Cap 10 Membrane 4 Housing 11, 11a, 11
b, 11c Slit 5 Side arm tube 12 Crown-shaped groove 6 Cover 13 Perforation 7 Sheath tube 14, 15, 16 Groove shape

Claims (3)

[Scope of utility model registration request] 1. A disc-shaped body made of a thermosetting resin having elasticity, wherein one surface side of the disc-shaped body has a mortar-shaped recess at its center, and the center of the recess. Has a non-permeable hole, and the other surface side is provided with a slit having a desired thickness from the surface toward the center, and the slits are provided at equal angles in multiple directions from the center of the disc-shaped body. Hemostasis valve that is characterized by being. 2. A concentric groove at least near the center of the surface of the mortar-shaped recess.
Hemostasis valve as described. 3. The hemostasis valve according to claim 1, wherein the impermeable hole provided in the mortar-shaped recess has a hole at the center thereof.