WO2020183624A1

WO2020183624A1 - Hemostatic valve device and guiding sheath

Info

Publication number: WO2020183624A1
Application number: PCT/JP2019/010099
Authority: WO
Inventors: 小林　洋平; 翔吉田
Original assignee: 日本ライフライン株式会社
Priority date: 2019-03-12
Filing date: 2019-03-12
Publication date: 2020-09-17
Also published as: JP7135198B2; JPWO2020183624A1

Abstract

The purpose of the present invention is to provide a hemostatic valve device that is excellent not only in liquid tightness in a slit formed in a valve body, but also in liquid tightness between a housing and the valve body.　This hemostatic valve device (100) is a hemostatic valve (20) device which is for a guiding sheath and is provided with a housing (10) and a hemostatic valve (20) mounted on the proximal end side of the housing (10). The hemostatic valve (20) is a double-structure elastic valve in which a first valve body (21) having a slit (23) therein and a second valve body (22) having a through-hole (24) therein with a diameter smaller than the diameter of an inserted device are stacked. A truncated cone-like recess section (17) is formed in the proximal end section of the housing (10). The first valve body (21) has an truncated elliptical cone-like protruding section (25) that can be fitted to the truncated cone-like recess section (17) formed in the housing (10), and the slit (23) is formed along a minor axis of an ellipse which is the shape of the top plate and the bottom plate of the truncated elliptical cone-like protruding section (25).

Description

Hemostatic valve device and guiding sheath

The present invention relates to a hemostatic valve device and a guiding sheath provided with a hemostatic valve device.

A guiding sheath (insert sheath) is used when introducing medical tubes such as catheters into the lumen of a living body.
The guiding sheath usually incorporates a hemostatic valve device to prevent blood from leaking from the sheath tube that composes the guiding sheath and air from entering the sheath tube.

As a hemostatic valve device mounted on a guiding sheath, a housing including a housing connected to the base end side of the sheath tube and a hemostatic valve mounted on the base end side of the housing are known ( See Patent Document 1).

Here, as a hemostatic valve (valve body), one in which a slit extending from one surface to the other surface is formed is often used (see Patent Document 2).
The slit formed in the hemostatic valve is closed when a device such as a medical tube is not inserted, which ensures liquidtightness (sealability) and prevents blood leakage when the device is not inserted. Has been done.

Further, as a hemostatic valve (valve body), one in which a through hole having a diameter smaller than the diameter of the device to be inserted is formed on the base end side of the slit has been introduced (see Patent Document 3).
According to the hemostatic valve having such a through hole, blood leakage can be prevented even when a device such as a catheter is inserted.

Further, in the hemostatic valve in which the slit is formed, a part of the valve body is formed in an elliptical shape (elliptical columnar or elliptical plate shape), and a slit is formed on the short axis of the ellipse, and the ellipse of the valve body is formed. By fitting the shaped portion into a perfectly circular (cylindrical or disc-shaped) recess formed in the housing, the elliptical long axis direction (direction in which the slit closes) is accompanied by elastic deformation of the elliptical portion. ), A technique for increasing the compressive force on the valve body and improving the liquidtightness due to the slit has been introduced (see Patent Document 4).

Japanese Patent No. 4603149 International Publication No. 2015/145936 Japanese Unexamined Patent Publication No. 7-136285 Japanese Patent No. 5450573

However, as in Patent Document 4, when the elliptical (elliptical column or elliptical plate) portion of the valve body is fitted into the perfect circular (cylindrical or disc) recess formed in the housing. Although the liquidtightness in the slit formed on the short axis of the ellipse is improved, the liquidtightness between the inner peripheral surface of the housing in the perfect circular recess and the outer peripheral surface of the valve body in the elliptical portion. There is a problem that it is not possible to secure sufficient sex.

The present invention has been made based on the above circumstances.
An object of the present invention is to provide a hemostatic valve device which is excellent not only in liquidtightness in a slit formed in a valve body but also in liquidtightness between a housing and a valve body.

The hemostatic valve device of the present invention is a hemostatic valve device including a housing connected to the proximal end side of the sheath tube and a hemostatic valve mounted on the proximal end side of the housing.
In the hemostatic valve, a first valve body in which a slit extending from one surface to the other surface is formed and a second valve body in which a through hole having a diameter smaller than the diameter of the device to be inserted is formed are stacked. It is a double-structured elastic valve,
A truncated cone-shaped recess that expands in diameter toward the base end is formed at the base end portion of the housing.
The first valve body has an elliptical truncated cone-shaped convex portion that can be fitted into the truncated cone-shaped concave portion formed in the housing, and the slit is formed on the top surface and the bottom surface of the truncated cone-shaped convex portion. It is characterized in that it is formed along the minor axis of an ellipse, which is a shape.

Here, the "elliptical frustum shape" is a frustum shape with an ellipse as the bottom surface.
The "elliptical truncated cone" in the truncated cone-shaped convex portion of the first valve body is the shape of the valve body before being fitted into the truncated cone-shaped concave portion of the housing and elastically deformed.

According to the hemostatic valve device having such a configuration, the truncated cone-shaped convex portion of the first valve body is elastically deformed and fitted to the truncated cone-shaped concave portion formed in the housing, whereby the elliptical cone is fitted. With the elastic deformation of the trapezoidal convex portion, the compressive force on the first valve body acting in the long axis direction (direction in which the slit closes) of the ellipse, which is the shape of the top surface and the bottom surface of the first valve body, is sufficiently high. Therefore, it is possible to sufficiently secure the liquidtightness (sealing property) in the slit of the first valve body.

Moreover, since the truncated cone-shaped convex portion of the first valve body is fitted into the truncated cone-shaped concave portion formed in the housing, the cylindrical (disk) -shaped concave portion has a cylindrical (disk) shape. Compared with the case where the convex portion is fitted, the operation of fitting the valve body to the housing is easier, and the inner peripheral surface of the housing in the truncated cone-shaped concave portion and the first in the truncated cone-shaped convex portion. A wide contact area with the outer peripheral surface of the valve body can be secured, and liquidtightness (sealing property) between the inner peripheral surface of the housing and the outer peripheral surface of the first valve body can be sufficiently ensured.

Furthermore, the second valve body that constitutes the hemostatic valve can sufficiently prevent the leakage of blood when the device is inserted.

In the hemostatic valve device of the present invention, the diameter of the circle which is the top surface shape of the conical recess of the housing is (d), the diameter of the circle which is the bottom surface of the conical recess is (D), and the first. The major axis of the ellipse, which is the top surface shape of the elliptical cone-shaped convex portion of the valve body, is (d _L ), the minor axis of this ellipse is (d _S ), and the bottom surface shape of the elliptical pyramid-shaped convex portion. of the major axis (D _L), when the minor axis of the ellipse and (D _S),
(D _S) / (d) and (D _S) the value of / (D) is 1.0 to 1.05
_{_{(D L) / (d S}} ) and the value of _{_{(D L) / (D S}} ) is 1.01 to 1.10
It is preferred values for _{_{(D L) / (d L}} ) and _{_{(D S) / (d S}} ) of 1.1 to 2.0.

According to the hemostasis valve of such a _{configuration, (d S) / (d} ) and (D _S) / by the value of (D) of 1.0 to 1.05 truncated elliptical cone-shaped convex portion The outer peripheral surface of the first valve body in the truncated cone-shaped convex portion and the inner peripheral surface of the housing in the truncated cone-shaped concave portion can be completely brought into close contact with each other due to the elastic deformation of the housing. It is possible to sufficiently secure the liquidtightness between the valve body and the outer peripheral surface.

Further, (d _L) / by the value of (d _S) and _{_{(D L) / (D S}} ) is 1.01 or more, with the elastic deformation of the truncated elliptical cone-shaped convex portion, the first valve body The compressive force on the first valve body acting in the long axis direction (direction in which the slit closes) of the ellipse, which is the shape of the top surface and bottom surface of the valve body, can be sufficiently increased, and the liquidtightness in the slit of the first valve body. Can be sufficiently secured.

_{Further, (d L) / (d} S) and (D _L) / by the value of (D _S) is 1.10 or less, with the elastic deformation of the elliptical frustum-shaped convex portions, elliptical frustum The outer peripheral surface of the first valve body in the convex portion and the inner peripheral surface of the housing in the truncated cone-shaped concave portion can be completely brought into close contact with each other over the entire circumference, and the inner peripheral surface of the housing and the outer peripheral surface of the first valve body can be brought into close contact with each other. Sufficient liquidtightness can be ensured between them.

Further, by the value of _{_{(D L) / (d L}} ) and _{_{(D S) / (d S}} ) is 1.1 or more, an elliptical frustum-shaped convex portion having a first valve member, formed in the housing It can be easily fitted to the truncated cone-shaped concave portion, and the contact area between the inner peripheral surface of the housing in the truncated cone-shaped concave portion and the outer peripheral surface of the first valve body in the elliptical truncated cone-shaped convex portion. It can be widely secured, and sufficient liquidtightness can be ensured between the inner peripheral surface of the housing and the outer peripheral surface of the first valve body.

_{Further, (D L) / (d} L) and (D _S) / by the value of (d _S) is 2.0 or less, the long axis of the ellipse is the shape of the top surface and the bottom surface of the first valve body The compressive force acting in the direction can be sufficiently transmitted to the slit, and the liquidtightness in the slit can be sufficiently ensured.

The hemostatic valve device of the present invention has not only liquidtightness in the slit formed in the first valve body (sealing property by closing the slit), but also the inner peripheral surface of the housing and the outer peripheral surface of the first valve body. Since the liquid tightness (seal property) between the two is also excellent, according to the hemostatic valve device of the present invention, it is possible to reliably prevent blood from leaking from the sheath tube and air from entering the sheath tube. ..

It is explanatory drawing which shows an example of the hemostatic valve device of this invention. It is sectional drawing (II-II sectional view) of the hemostatic valve device shown in FIG. It is a partially enlarged sectional view of the hemostatic valve device shown in FIG. 1 (detailed view of Part III of FIG. 2). It is explanatory drawing which shows the shape of the 1st valve body of the hemostatic valve which constitutes the hemostatic valve device shown in FIG. 1, (1) is a plan view, (2) is the AA cross-sectional view of (1), (1). 3) is a cross-sectional view taken along the line BB of (1). It is explanatory drawing which shows the shape of the 2nd valve body of the hemostatic valve which constitutes the hemostatic valve device shown in FIG. 1, (1) is a plan view, (2) is a CC sectional view of (1), (1). 3) is a cross-sectional view taken along the line DD of (1). It is an external view which shows an example of the guiding sheath which incorporated the hemostatic valve device of this invention.

<Embodiment>
Hereinafter, embodiments of the present invention will be described with reference to the drawings.
The hemostatic valve device 100 of this embodiment shown in FIGS. 1 to 3 is used by being incorporated in a guiding sheath 500 as shown in FIG.

The hemostatic valve device 100 fixes the housing 10, the hemostatic valve 20 (first valve body 21 and the second valve body 22) mounted on the base end side of the housing 10, and the hemostatic valve 20 to the housing 10. It is provided with a cap 30 for the purpose.

In the housing 10 constituting the hemostatic valve device 100, the housing main body portion 11, the hub portion 13, and the side port portion 15 are integrally molded with a hard resin.
Examples of the hard resin constituting the housing 10 include polycarbonate, ABS and PP.

The hub portion 13 that extends continuously to the tip side of the housing body portion 11 is a sheath tube (a sheath tube 51 as shown in FIG. 6) that constitutes a guiding sheath, and the base end portion thereof extends inside the handle 53. It is connected to the base end side of the existing housing.
The side port portion 15 extending laterally from the housing main body portion 11 is connected to a three-way stopcock (three-way stopcock 57 shown in the figure) via a side arm (side arm 55 shown in the figure) of the guiding sheath.

As shown in FIGS. 2 and 3, the base end portion of the housing 10 (housing body portion 11) is continuous with a truncated cone-shaped recess 17 on the tip side and a truncated cone-shaped recess 17 on the tip side communicating with the inside of the housing 10. A truncated cone-shaped recess 19 on the base end side is formed.

The diameter (d) of the circle having the top surface shape of the truncated cone-shaped recess 17 on the tip side is usually 2 to 5 mm, and a suitable example is 3.76 mm.
The diameter (D) of the circle, which is the shape of the bottom surface of the truncated cone-shaped recess 17 on the tip side, is usually 2.5 to 8 mm, and a suitable example is 5.35 mm.

The ratio of the diameter (D) of the circle (D) / (d), which is the bottom surface of the truncated cone-shaped recess 17 on the tip side, to the diameter (d) of the circle, which is the top surface shape of the truncated cone-shaped recess 17 on the tip side. The value is preferably 1.1 to 2.0, and a suitable example is 1.4 (5.35 mm / 3.76 mm).
The depth of the truncated cone-shaped recess 17 on the tip side (distance between the top surface and the bottom surface of the truncated cone) is usually 0.5 to 3 mm, and a suitable example is 1.42 mm.

The diameter of the circle having the top surface of the truncated cone-shaped recess 19 on the base end side is usually 4 to 8 mm, and a suitable example is 4.41 mm.
The diameter of the circle (opening diameter on the base end side of the housing 10), which is the bottom surface of the truncated cone-shaped recess 19 on the base end side, is usually 4.5 to 12 mm, and a suitable example is 8.52 mm. To.
The depth of the truncated cone-shaped recess 19 on the base end side (distance between the top surface and the bottom surface of the truncated cone) is usually 1 to 5 mm, and a suitable example is 2.78 mm.

The hemostatic valve 20 constituting the hemostatic valve device 100 has a double structure in which a first valve body 21 having a shape as shown in FIG. 4 and a second valve body 22 having a shape as shown in FIG. 5 are stacked. Elastic valve.
As shown in FIGS. 2 and 3, the hemostatic valve 20 (first valve body 21 and first valve body 22) has a truncated cone-shaped recess (tip-side truncated cone shape) formed at the base end of the housing 10. It is housed in the recess 17 and the truncated cone-shaped recess 19) on the base end side.

The hemostatic valve 20 (first valve body 21 and second valve body 22) is formed of an elastic resin material or rubber material. Examples of the material constituting the hemostatic valve 20 include silicone resin, various rubbers, and thermoplastic elastomers.

The tip portion 25 of the first valve body 21 shown in FIGS. 4 (1) to 4 (3) is an elliptical truncated cone-shaped convex portion that can be fitted into the truncated cone-shaped concave portion 17 on the tip side formed in the housing 10. There is.

In the first valve body 21 of the hemostatic valve 20, one slit 23 extending from one surface to the other surface extends from the central axis of the first valve body 21 (central axis O of the hemostatic valve device 100) to both sides in the radial direction. Is formed in.
The slit 23 is formed along the minor axis of an ellipse, which is the shape of the top surface and the bottom surface of the tip portion 25 (elliptical frustum-shaped convex portion) of the first valve body 21.
Here, a substantially truncated cone-shaped concave portion having a shallow bottom is formed on the top surface of the elliptical truncated cone-shaped convex portion at the tip portion 25.

The bottom surface of the elliptical frustum-shaped convex portion at the tip portion 25 of the first valve body 21 is a cross section of the first valve body 21 at the boundary between the tip portion 25 and the base end portion 27.
The base end portion 27 of the first valve body 21 is a truncated cone-shaped convex portion that fits into the truncated cone-shaped concave portion 19 formed in the housing 10.
The base end portion 27 of the first valve body 21 is formed with a truncated cone-shaped recess into which the tip end portion 26 of the second valve body 22 is fitted.

The major axis (d _L ) of the ellipse, which is the top surface shape of the tip 25 (convex part of the elliptical frustum) of the first valve body 21, is usually 2 to 6.6 mm, and a suitable example is 3. It is set to 96 mm.
As the minor axis of the ellipse (d _S), is usually 1.9 ~ 6 mm, it is 3.76mm as a preferable example.

The major diameter of a bottom shape oval tip of the first valve body 21 25 (truncated elliptical cone-shaped convex portion) (D _L), is usually 2.5 ~ 8.8 mm, as a preferable example 5 It is said to be .64 mm.
As the minor axis of the ellipse (D _S), is usually 2.3 ~ 8 mm, it is 5.35mm as a preferable example.

The minor axis (d _S ) of the ellipse, which is the top surface shape of the tip portion 25 (elliptical truncated cone-shaped convex portion), with respect to the diameter (d) of the circle, which is the top surface shape of the truncated cone-shaped recess 17 on the tip side formed in the housing 10. ) To the value of [(d _S ) / (d)] and the bottom surface of the tip 25 (elliptical truncated cone) with respect to the diameter (D) of the circle which is the bottom shape of the truncated cone on the tip side. the ratio of the minor axis of the a shape elliptical (D _S) is preferably from 1.0 to 1.05 as the value of [(D _S) / (D)], as a preferable example 1.0 ( 3.76 mm / 3.76 mm and 5.35 mm / 5.35 mm).

By (d _S) / (d) and the value of (D _S) / (D) is 1.0 to 1.05 with the elastic deformation of the tip portion 25 (truncated elliptical cone-shaped convex portion), The outer peripheral surface of the tip portion 25 (elliptical frustum-shaped convex portion) of the first valve body 21 and the inner peripheral surface of the truncated cone-shaped recess 17 on the tip side of the housing 10 can be completely brought into close contact with each other, and the first valve body Sufficient liquidtightness can be ensured between the outer peripheral surface of the 21 and the inner peripheral surface of the housing 10.

(D _S) / (d) and the outer peripheral surface of the (D _S) / if the value of (D) is less than 1.0, the tip portion of the first valve body 21 25 (truncated elliptical cone-shaped convex portion) A gap is formed between the housing 10 and the inner peripheral surface of the truncated cone-shaped recess 17 on the tip end side, and the two cannot be completely brought into close contact with each other.

On the other hand, when these values exceed 1.05, the tip portion 25 (elliptical truncated cone-shaped convex portion) of the first valve body 21 may be fitted into the truncated cone-shaped concave portion 17 on the tip side of the housing 10. It becomes difficult, and it becomes difficult to bring the outer peripheral surface of the tip portion 25 (elliptical truncated cone-shaped convex portion) of the first valve body 21 into close contact with the entire circumference of the inner peripheral surface of the truncated cone-shaped concave portion 17 on the distal end side.

The ratio of the major axis (d _L ) to the minor axis (d _S ) of the ellipse, which is the top surface shape of the tip 25 (elliptical frustum-shaped convex portion) of the first valve body 21, [(d _L ) / (d _S )] values, and the value of the distal portion 25 the ratio of the major axis to the minor axis of the ellipse is the shape of the bottom surface (truncated elliptical cone-shaped convex _{_{portion) (D S) (D L}} ) _{_{[(D L) / (D S}} ) ] It is preferably 1.01 to 1.10, and a suitable example is 1.05 (3.96 mm / 3.76 mm and 5.64 mm / 5.35 mm).

If _{_{(d L) / (d S}} ) and the value of _{_{(D L) / (D S}} ) is less than 1.01 is the shape of the top surface and the bottom surface of the tip portion 25 of the first valve body 21 The compressive force on the first valve body 21 acting in the long axis direction of the ellipse (the direction in which the slit 23 closes) cannot be sufficiently increased, and the liquidtightness of the slit 23 of the first valve body 21 is sufficiently ensured. It may not be possible.

On the other hand, when these values exceed 1.10, the tip portion 25 (elliptical truncated cone-shaped convex portion) of the first valve body 21 may be fitted into the truncated cone-shaped concave portion 17 on the tip side of the housing 10. It becomes difficult, and it becomes difficult to bring the outer peripheral surface of the tip portion 25 (elliptical truncated cone-shaped convex portion) of the first valve body 21 into close contact with the entire circumference of the inner peripheral surface of the truncated cone-shaped concave portion 17 on the distal end side.

The distal end of the first valve body 21 25 major axis of the ellipse is a bottom shape of the tip portion 25 against the top surface shape of ellipse major axis (elliptical frustum-shaped convex portion) (d _L) (truncated elliptical cone-shaped convex portion) the value of the ratio _{_{[(D L) / (d L}} ) ] of (D _L), and the tip 25 tip diameter to the minor diameter of a top surface shape of an ellipse (elliptic truncated conic protrusions) (d _S) 25 it as the value of the ratio of the minor axis of the ellipse is the shape of the bottom surface (truncated elliptical cone-shaped convex portion) (D _S) _{_{[(D S) / (d S}} ) ] is 1.1-2.0 Is preferable, and a suitable example is 1.4 (5.64 mm / 3.96 mm and 5.35 mm / 3.76 mm).

(D _L) / in (d _L) and (D _S) / if the value of (d _S) is less than 1.1, the tip-side frustoconical recess 17 of the housing 10, the first valve body 21 It becomes difficult to fit the tip portion 25 (elliptical truncated cone shape), and the inner peripheral surface of the tip side truncated cone shape recess 17 of the housing 10 and the tip portion 25 (elliptical truncated cone shape) of the first valve body 21 A wide contact area with the outer peripheral surface of the convex portion) could not be secured, and the liquid tightness between the inner peripheral surface of the truncated cone-shaped concave portion 17 on the tip side and the outer peripheral surface of the tip portion 25 of the first valve body 21. It may not be possible to secure sex.

On the other hand, when these values exceed 2.0, the first acting in the long axis direction (the direction in which the slit 23 closes) of the ellipse, which is the shape of the top surface and the bottom surface of the tip portion 25 of the first valve body 21. The compressive force on the valve body 21 cannot be sufficiently increased, and the liquidtightness in the slit 23 of the first valve body 21 may not be sufficiently ensured.

The height of the tip portion 25 of the first valve body 21 (distance between the top surface and the bottom surface of the truncated cone) coincides with the depth of the truncated cone-shaped recess 17 on the tip side, and is usually 0.5 to 3 mm, which is preferable. To give an example, it is 1.42 mm.
The inclination angle (θ) of the outer peripheral surface of the tip portion 25 of the first valve body 21 is preferably 45 to 75 °, and a suitable example is 60 °.

The diameter of a circle having a top surface shape of the base end portion 27 (conical truncated cone-shaped convex portion) of the first valve body 21 is usually 4 to 8 mm, and a suitable example is 6 mm.
The diameter of the circle having the bottom surface of the truncated cone 27 (conical truncated cone) is usually 4.5 to 10 mm, and a suitable example is 6.57 mm.

The tip portion 25 (elliptical truncated cone-shaped convex portion) of the first valve body 21 is fitted into the truncated cone-shaped concave portion 17 on the distal end side formed in the housing 10, so that the truncated cone 25 is formed on the truncated cone on the distal end side. Along the shape of the shaped recess 17, it is elastically deformed from an "elliptical truncated cone" to a "truncated cone".
As the tip 25 of the first valve body 21 is elastically deformed, the tip 25 has a slit formed in the major axis direction of the ellipse (a slit formed along the minor axis of the ellipse), which is the shape of the top surface and the bottom surface of the tip 25. A compressive force acts in the direction in which the 23 is closed), whereby the slit 23 of the first valve body 23 is firmly closed and sufficient liquidtightness is ensured.

Further, since the tip portion 25 (elliptical truncated cone-shaped convex portion) of the first valve body 21 is fitted into the truncated cone-shaped concave portion 17 on the tip side formed in the housing 10, a cylindrical or disc-shaped concave portion is formed. Compared with the case where a cylindrical or disc-shaped convex portion is fitted to the housing 10, the operation of fitting the first valve body 21 to the housing 10 is easier, and the truncated cone-shaped concave portion on the tip side of the housing 10. A wide contact area between the inner peripheral surface of 17 and the outer peripheral surface of the tip portion 25 (elliptical truncated cone-shaped convex portion) of the first valve body 21 can be secured, and the inner peripheral surface of the truncated cone-shaped concave portion 17 on the tip side can be secured. And the liquidtightness (sealing property) between the first valve body 21 and the outer peripheral surface of the tip portion 25 can be sufficiently ensured.

As shown in FIGS. 5 (1) to 5 (3), in the second valve body 22 of the hemostatic valve 20, a through hole 24 having a diameter smaller than the diameter of the device to be inserted is provided as the central axis (hemostatic) of the second valve body 22. It is formed on the central axis O) of the valve device 100.
The diameter of the through hole 24 varies depending on the diameter of the device to be inserted, but is usually 0.3 to 3 mm, and a suitable example is 0.5 mm.

The tip portion 26 of the second valve body 22 is a convex portion that fits into the concave portion formed in the base end portion 27 of the first valve body 21.

The base end portion 28 of the second valve body 22, together with the base end portion 27 (conical truncated cone-shaped convex portion) of the first valve body 21, is a cone that fits into the truncated cone-shaped concave portion 19 formed in the housing 10. It is a trapezoidal convex part.
A truncated cone-shaped recess communicating with the through hole 24 is formed in the base end portion 28 of the second valve body 22. The recess allows the device to be inserted to be smoothly guided to the through hole 24.

The diameter of the circle having the top surface shape of the base end portion 28 (conical truncated cone-shaped convex portion) of the second valve body 22 is usually 4 to 12 mm, and a suitable example is 8.0 mm.
The diameter of the circle having the bottom surface shape of the base end portion 28 (conical truncated cone-shaped convex portion) of the second valve body 22 is usually 5 to 13 mm, and a suitable example is 8.71 mm.
The height of the base end portion 28 of the second valve body 22 (distance between the top surface and the bottom surface of the truncated cone) is usually 1 to 5 mm, and a suitable example is 2.0 mm.

The second valve body 22 constituting the hemostatic valve 20 can prevent blood leakage even when a device such as a catheter is inserted.

According to the hemostatic valve device 100 of the present embodiment, the tip portion 25 (elliptical truncated cone-shaped convex portion) of the first valve body 21 is fitted into the truncated cone-shaped concave portion 17 on the distal end side of the housing 10. Sufficient liquidtightness (sealing property) in the slit 23 of the first valve body 21 can be ensured, and the inner peripheral surface of the truncated cone-shaped recess 17 on the tip side and the outer circumference of the tip portion 25 of the first valve body 21. Sufficient liquidtightness (sealing property) with the surface can be ensured.
Further, by providing the second valve body 22, it is possible to sufficiently prevent the leakage of blood when the device is inserted.

100 Stopcock valve device 10 Housing 11 Housing body 13 Hub 15 Side port 17 Tip-side truncated cone-shaped recess 19 Base-end-side truncated cone-shaped recess 20 Stopcock valve 21 1st valve body 22 2nd valve body 23 Slit 24 Through hole 25 Tip of 1st valve body 26 Tip of 2nd valve body 27 Base end of 1st valve 28 Base end of 2nd valve body 30 Cap 500 Guiding sheath 51 Sheath tube 55 Side arm 57 Three-way stopcock

Claims

A hemostatic valve device including a housing connected to the proximal end side of a sheath tube and a hemostatic valve mounted on the proximal end side of the housing.
In the hemostatic valve, a first valve body in which a slit extending from one surface to the other surface is formed and a second valve body in which a through hole having a diameter smaller than the diameter of the device to be inserted is formed are stacked. It is a double-structured elastic valve,
A truncated cone-shaped recess that expands in diameter toward the base end is formed at the base end portion of the housing.
The first valve body has an elliptical truncated cone-shaped convex portion that can be fitted into the truncated cone-shaped concave portion formed in the housing, and the slit is formed on the top surface and the bottom surface of the truncated cone-shaped convex portion. A hemostatic valve device characterized in that it is formed along the short axis of an ellipse having a shape.
The diameter of the circle that is the top surface of the conical recess of the housing is (d), the diameter of the circle that is the bottom of the conical recess of the housing is (D), and the elliptical cone of the first valve body. the major axis of a top surface shape oval-shaped convex portion (d L), short diameter (d S) of the ellipse, the major axis of a bottom shape ellipse of the elliptical frustum-shaped protrusion (D L), when the minor axis of the ellipse and (D S),
[1] (d S) / (d) and (D S) / the value of (D) 1.0 to 1.05
[2] (d L) / (d S ) and (D L) / the value of (D S) is 1.01 to 1.10,
[3] (D L) / (d L ) and (D S) / the value of (d S) is 1.1-2.0
The hemostatic valve device according to claim 1, wherein the hemostatic valve device is characterized by the above.
A guiding sheath provided with the hemostatic valve device according to claim 1 or 2.