JPH0553652U - The valvular body of a catheter introducer hemostatic valve - Google Patents

Abstract

(57) [Summary] [Purpose] To provide a valvular body of a catheter introducer hemostatic valve capable of completely preventing blood leakage and smoothly inserting and removing a catheter or the like. A small hole passing through the central axis of the valve body is formed on one surface of the valve body, and the small hole passing through the central axis is passed through the valve body.
At least one slit having a length larger than the diameter of the small hole was formed. The small hole is 50% of the thickness of the valve body.
And a cylindrical shape having a diameter of 0.5 to 1 mm, or a depth of more than 50% of the thickness of the valvular body, 1 to
It is conical with an entrance diameter of 2 mm.

Description

[Detailed description of the device]

[0001]

[Industrial application]

 The invention relates to a valvular body of a catheter introducer hemostatic valve used for diagnostic treatment by angiography.

[0002]

[Prior Art]

 Conventionally, a catheter introducer has been used as an instrument for introducing an angiographic catheter or the like into a blood vessel. FIG. 8 is a side view showing the catheter introducer, and FIG. 9 is a side view of the catheter introducer inserted into a blood vessel. In the figure, 1 is a blood vessel, 2 is an incision, 3 is a catheter introducer, and 4 is the book. A body, 5 is its sheath, 6 is a dilator, 7 is a guide wire, and 8 is a catheter.

In operation, the skin near the target blood vessel 1 is incised to form an incision 2 and a hollow needle (not shown) having an inner needle inserted therein is introduced into the blood vessel 1 through the incision 2. To do. Then, the guide wire 7 is inserted into the hollow needle from which the inner needle has been removed, and then the hollow needle is removed to leave only the guide wire. Then, the catheter introducer 3 with the dilator 6 inserted therein is inserted into the blood vessel (1) using the guide wire 7 as a guide. Then, with the sheath 5 of the catheter introducer inserted into the blood vessel 1, the dilator 6 and the guide wire 7 are removed, and then the catheter 8 is inserted into the sheath 5 so that the distal end of the catheter is inserted into the blood vessel 1. Guide and end the insertion of the catheter 8 into the blood vessel 1.

At the time of inserting the catheter 8 into the blood vessel 1, for example, the catheter introducer 3 is inserted into the blood vessel 1, and the sheath 5 is left inside the blood vessel 1 while the dilator 6 and the guide wire 7 are inserted. When the catheter 8 is removed and the catheter 8 is inserted through the catheter introducer 3 to be inserted into the blood vessel 1, blood in the blood vessel 1 may flow backward and leak from the catheter introducer 3. In order to prevent this, a hemostatic valve is provided on the main body 4 of the catheter introducer.

FIG. 10 is a perspective view showing an example of a conventional hemostasis valve. As shown in the figure, the hemostasis valve includes a valve body 9 and a valve body 10 between a lid 4a of a main body 4 and a cylindrical frame 4b. It is formed by stacking and inserting. The valve leaflets 9 and 10 are both made of an elastic material, and a small hole 9a is formed in the center of the valve leaflet 9 and a slit 10a is formed in the center of the valve leaflet 9. Therefore, when the guide wire 7 or the catheter 8 is inserted through the valve leaflets 9 and 10, the valve leaflets 9 and 10 elastically adhere to the outer peripheral portions of the wire 7 and the catheter 8 to prevent leakage of blood inside the main body 4. To do. When the wire 7 and the catheter 8 are removed, the slit 10a of the valvular body 10 comes into close contact with the main body 4 to prevent blood from leaking in the same manner as described above. The hemostatic valve of the catheter introducer is constructed as described above.

[0006] In addition to the structure shown in Fig. 10, the structure of a catheter introducer hemostatic valve formed by laminating a plurality of valve films is shown in Fig. 11, and as shown in Fig. 11, a slit 11, a small hole 12a, and a U-shaped groove, respectively. There is also one formed by laminating three valve leaflets 11, 12, 13 provided with 13a.

Further, the hemostatic valve of the catheter introducer is not limited to one formed by laminating a plurality of valve film bodies as described above, and many of them are integrated into one valve film body. The valve membrane body shown in FIG. 13 shows an example thereof. In the figure, the valve body 14 has a mortar-shaped recess 14a on one surface and a slit 14b on the other surface, and the center of the recess 14a and the center of the slit 14b are connected by a small hole 14c. It will be. As described above, various types of hemostasis valves for catheter introducers have been devised.

[0008]

[Problems to be solved by the device]

 In the first place, the conditions required for a hemostasis valve are such that blood does not leak even when a small-diameter guide wire is inserted, and a large-diameter dilator or catheter can be smoothly inserted / extracted without resistance, and even when there is no insert, leakage occurs. There are three points.

The hemostasis valve formed by stacking a plurality of valve membranes meets the above condition for the time being, but during repeated insertion and removal of a large-diameter rod-shaped body, the valves did not mesh well. When a rod-shaped body is pulled out, leakage may occur. If the valve membrane is made thicker to prevent this leakage, the leakage will decrease but the insertion resistance will increase, making it difficult to operate.

Although the integrated valve shown in FIGS. 12 and 13 is slightly improved as compared with the laminated valve, if the guide wire is quickly inserted and withdrawn, leakage is likely to occur and the insertion resistance of the large-diameter rod-shaped body is sufficient. It is difficult to make it small. As described above, the conventional valvular body cannot be said to be perfect, and there are still some problems.

The present invention has been made in order to solve the above-mentioned problems of the conventional device. A valve membrane of a catheter introducer hemostasis valve that completely prevents blood leakage and allows smooth insertion and removal of a catheter or the like is provided. It is the one we are trying to provide.

[0012]

[Means for Solving the Problems]

 In order to achieve the above-mentioned object, the valvular body of the hemostatic valve according to the present invention has a small hole formed on one surface thereof through the center of the valvular body and a slit penetrating the valvular body through the center of the valvular body. The diameter of the small hole is 0.5 mm to 1 mm, and the depth of the small hole is 50% or more of the thickness of the valve membrane. The small hole may have a conical shape having an entrance diameter of 1 to 2 mm. Further, the length of the slit should be larger than the diameter of the eyelet.

[0013]

[Action]

 When a small-diameter guide wire or the like is inserted through the center of the hemostasis valve, the guide wire is inserted through the small hole and the slit formed in the valve membrane of the hemostasis valve. The diameter of the small hole is slightly smaller than the diameter of the guide wire, but by selecting the diameter and length of the small hole as well as the material of the valve, the hemostasis valve can be used not only for small guide wires but also for large diameter It is also possible to insert a cable or the like. Further, since the elastic material forming the valve clamps the outer peripheral portion of the rod-shaped body such as the guide wire inserted into the small hole, leakage of blood or the like is prevented. Furthermore, since a slit is formed in the lower part of the small hole, even if the length of the small hole is made small to some extent and the hardness of the material of the valve membrane is made small, the hemostatic valve can maintain sufficient pressure resistance. It is possible.

[0014]

【Example】

Embodiment 1 FIGS. 1 and 2 are perspective views of a valve membrane of a catheter introducer hemostatic valve and an A = A cross-sectional view of FIG. 1 showing an embodiment of the present invention, in which 20 is a valve membrane of the hemostatic valve. , 21 is a small hole, 22 is a slit, d ₁ is the diameter of the small hole 21, h is the depth of the small hole 21, and H is the thickness of the valve membrane. As shown in the figure, a small hole 21 having a diameter d ₁ of 0.5 to ₁ mm and a depth h of 50% or more of the thickness H of the valve membrane is formed at the center of one surface of the valve membrane 20 of the hemostatic valve of the catheter introducer. And a slit 22 is formed which passes through the central axis of the small hole and penetrates from one surface of the valve membrane to the other surface. The slit 22 does not always have to penetrate the valve membrane. If it is penetrated, when the guide wire is inserted, the liquid may leak from the slit part beside the hole.If it is not penetrated, the liquid will be prevented from leaking, but the insertion resistance of a large dilator or catheter May become too large. Therefore, the specifications of the slit 22 should be determined in consideration of the usage of the introducer and the material of the valve membrane.

Embodiment 2 FIGS. 3 and 4 are perspective views of a valve membrane showing another embodiment and a sectional view taken along the line BB in FIG. 3, where 23 is a valve membrane, 24 is a small hole, and 25 is a slit. The shape of the small hole 24 is a conical shape in which the diameter d ₂ on the surface of the valvular body is 1 to ₂ mm and becomes smaller toward the inside of the valvular body. As a result, the resistance when inserting a catheter is reduced, which is convenient for use.

Embodiment 3 FIG. 5 is a side sectional view of a valve membrane showing still another embodiment, showing an example in which the center of the small hole 25 and the center of the slit 26 are not aligned. Also in this embodiment, the small hole 25 has a diameter of 0.5 to 1 mm and a length of 50% or more of the thickness H of the valve membrane.

Embodiment 4 In each of the above embodiments, the number of slits is one, but the number of slits is not limited to one and may be plural. 6 and 7 are perspective views of a valve membrane body having a plurality of slits. FIG. 6 has three slits 27 and FIG. 7 has four slits 30.

[0018]

[Effect of the device]

 The present invention forms a small hole having a diameter of 0.5 to 1 mm and a depth of 50% or more of the thickness of the valvular body at the center of one surface of the valvular body of the catheter introducer hemostatic valve, and passes through the center of the valvular body. Since the slit penetrating the valve membrane was formed, the following excellent effects were obtained. It has become possible to prevent leakage of blood that has flowed back into the body of the catheter introducer regardless of whether the guide wire or catheter is inserted or removed, or removed. The guide wire and catheter can be inserted and removed smoothly.

[Brief description of drawings]

FIG. 1 is a perspective view of a leaflet of a catheter introducer hemostatic valve according to an embodiment of the present invention.

FIG. 2 is a side sectional view of the valve membrane.

FIG. 3 is a perspective view of a leaflet of a catheter introducer hemostatic valve according to another embodiment of the present invention.

FIG. 4 is a side sectional view of the valve membrane.

FIG. 5 is a side cross-sectional view of a leaflet of a catheter introducer hemostatic valve according to another embodiment of the present invention.

FIG. 6 is a perspective view of a leaflet of a catheter introducer hemostatic valve according to another embodiment of the present invention.

FIG. 7 is a perspective view of a leaflet of a catheter introducer hemostatic valve according to another embodiment of the present invention.

FIG. 8 is a side view of a catheter introducer.

FIG. 9 is an explanatory diagram showing a usage example of the catheter introducer.

FIG. 10 is a perspective view showing a configuration of a conventional catheter introducer hemostatic valve.

FIG. 11 is a perspective view showing a conventional valve membrane body.

FIG. 12 is a perspective view showing a conventional valve membrane body.

FIG. 13 is a cross-sectional view taken along the line CC of the valve membrane body.

[Explanation of symbols]

 20 …… Valve body 21 …… Small hole 22 …… Slit 23 …… Small hole 24 …… Slit 25 …… Small hole 26 …… Slit 27 …… Small hole 28 …… Slit 29 …… Small hole 30 …… Slit

Claims (3)

[Scope of utility model registration request] 1. A hemostasis valve of a catheter introducer in which a valve membrane is inserted between a lid and a cylindrical frame of a catheter introducer body, wherein a small hole passing through a central axis of the valve membrane on one surface of the valve membrane. And at least one slit having a length larger than the diameter of the small hole and formed through the central axis and penetrating the valve membrane, the valve membrane of the catheter introducer hemostatic valve. 2. The catheter introducer hemostasis according to claim 1, wherein the small hole has a cylindrical shape having a depth exceeding 50% of the thickness of the valvular body and a diameter of 0.5 to 1 mm. The valve valvular body. 3. The catheter introducer hemostasis according to claim 1, wherein the small hole has a conical shape having a depth of more than 50% of the thickness of the valvular body and an inlet diameter of 1 to 2 mm. The valve valvular body.