JPH0947512A - Medical valve and auxiliary inserting equipment for medical use - Google Patents

Abstract

PROBLEM TO BE SOLVED: To lessen insert resistance of a catheter or the like and to firmly prevent leakage of body fluid from a body pipe and cavity by using a medical valve, which consists of elastic material with a few slits and with the top convex face and the bottom concave face, and is fixed to inserting equipment. SOLUTION: A medical valve consists of a disclike elastic material which has a few slits 4 penetrating from the convex top face 2 to the concave bottom face 3. With the concave bottom face 3, deformation of the medical valve upon inserting of a catheter or the like can be restricted with reduced insert resistance. This makes the insertion of the catheter or the like easy. The side face of this medical valve is fixed to a hollow holding part located at the inner wall of a sheath-hub of auxiliary inserting equipment for medical use. Through this medical valve, a catheter is inserted. With this sealed medical valve, no blood could flow outside.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical valve body and a medical insertion aid. More specifically, the present invention has a low resistance when a tube such as a catheter or a guide wire is pushed through a slit and inserted into a living body lumen, and can prevent leakage of body fluid from the living body lumen. The present invention relates to a medical valve body and a medical insertion aid including the valve body fixedly mounted.

[0002]

2. Description of the Related Art Intra-aortic balloon pumping method (IABP method) used for the treatment of heart failure such as heart failure,
In therapeutic methods such as the percutaneous coronary angioplasty method (PTCA method) used to widen the blood vessels around the heart and the thermodilution catheter method (TDC method) used to measure the blood flow in the heart, arteriovenous veins of patients are used. Insert the catheter into the blood vessel. A medical insertion aid, a so-called introducer, is used to insert a catheter into a blood vessel of a patient. The introducer has a sheath made of a tubular body and a sheath hub having an inner cavity as essential components, and further has a needle-shaped dilator that is removably inserted into the sheath, if necessary. A sheath is percutaneously inserted into a blood vessel of a patient, and a catheter or the like is inserted into the blood vessel through the inside (lumen) of the sheath with the tip of the sheath left inside the blood vessel. In such an introducer, a valve element is attached to the sheath hub, and after the sheath is left in the blood vessel, blood is prevented from leaking from the blood vessel of the patient through the sheath. As a conventionally used valve element, a disc-shaped valve element made of an elastic material having a slit-shaped contact hole formed therein is known. However, in the conventional valve body, when the catheter or the guide wire is inserted into the valve body, the valve body is easily pushed and deformed in the insertion direction, the resistance at the time of inserting the catheter etc. becomes high, and the catheter etc. It may not be easy to insert.

[0003]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a medical valve body and a medical insertion assisting tool which have a small insertion resistance of a catheter or the like and can surely prevent leakage of body fluid from a living body lumen. It was done for the purpose.

[0004]

As a result of intensive studies to solve the above-mentioned problems, the present inventors formed a disc-shaped medical valve body having a slit in which the upper surface is concave and the lower surface is convex. By doing so, it was found that the resistance when inserting a catheter or the like can be remarkably reduced, and the present invention has been completed based on this finding. That is, the present invention
(1) A medical valve body made of a disk-shaped elastic body having a slit penetrating from an upper surface to a lower surface, the upper surface being a concave surface and the lower surface being a convex surface, which is fixedly mounted in a medical insertion aid. And a medical insertion aid having (2) a lumen, wherein the medical valve body according to (1) is fixedly mounted on the wall surface of the lumen. Is provided. Further, as a preferred embodiment of the present invention,
(3) The medical valve element according to item (1), wherein the lower surface is formed in a conical shape, and (4) Item (1) or item (1), in which the upper surface is formed into a mortar shape.
The medical valve element according to item (3), (5) the first (1) item, the item (3) or the item (3) which has a recessed pocket portion in the central portion of the slit on the upper surface
(4) The medical valve element according to item (4), (6) the concave surface of the pocket portion is formed by a curved surface without an angle from the inner wall of the recess to the bottom, (1), (3), and (4). The medical valve element according to item or (5), (7) the length of the slit expands from the upper surface toward the lower surface, (1), (3), (4), () The medical valve element according to item 5) or (6), and (8) a medical insertion aid having an inner cavity, wherein the wall surface of the inner wall has an item (3), an item (4),
(5), (6) or (7) The medical insertion aid comprising the medical valve body fixedly mounted, and (9) the concave holding portion provided on the inner wall, the medical valve. The medical insertion aid according to item (2) or (8), in which the medical valve body is fixedly mounted by inserting and holding the side surface of the body, can be mentioned.

The present invention will be described in detail below with reference to the drawings. FIG. 1 is a plan view and a sectional view taken along line AA of a conventional medical valve body. The conventional medical valve body is a disk-shaped elastic body 1,
Some of them have slits 4 penetrating from the upper surface 2 to the lower surface 3, and the upper surface is formed in a concave shape as shown in the figure, but the lower surface is all flat. When a catheter or guide wire is inserted into such a medical valve body, the medical valve body is pushed and deformed in the insertion direction, increasing the resistance when inserting the catheter etc., making it difficult to insert the catheter etc. in the medical field. May be. FIG. 2 is a plan view and an AA line cross-sectional view of one embodiment of the medical valve body of the present invention. The medical valve body of the present invention comprises a disc-shaped elastic body 1 having a slit 4 penetrating from an upper surface 2 to a lower surface 3, and the upper surface 2 is a concave surface,
The lower surface 3 is a convex surface. By making the lower surface a convex surface, deformation of the medical valve body when inserting a catheter or the like is suppressed, insertion resistance is reduced, and insertion of a catheter or the like is facilitated. FIG. 3 is a plan view and a sectional view taken along line AA of another aspect of the medical valve body of the present invention. The medical valve body of this aspect,
The lower surface has a conical shape. By forming the conical lower surface 5, the insertion resistance of the catheter or the like is reduced, and the insertion of the catheter or the like is facilitated. FIG. 4 is a plan view and a sectional view taken along line AA of another aspect of the medical valve body of the present invention. The upper surface of the medical valve body of this aspect is formed in a mortar shape.
By forming the mortar-shaped upper surface 6, insertion resistance is reduced when inserting a catheter or the like, and insertion of the catheter or the like is facilitated. 5 (a) is a plan view of another embodiment of the medical valve body of the present invention, FIG. 5 (b) is a sectional view taken along the line AA, and FIG. 5 (c) is a sectional view taken along the line BB. It is a line sectional view. In the medical valve body of this aspect, a cup-shaped pocket portion 7 is provided in the center of the slit on the mortar-shaped upper surface. By providing the pocket portion, the tip of the catheter or the like can be easily positioned when inserting the catheter or the like, and the airtightness between the catheter and the medical valve body is improved.

FIG. 6 (a) is a plan view of another embodiment of the medical valve body of the present invention, FIG. 6 (b) is a sectional view taken along the line AA, and FIG. 6 (c) is It is a BB line sectional view. In the medical valve body according to this aspect, the concave surface of the pocket portion 7 at the center of the slit in the mortar-like upper surface is formed as a curved surface without corners from the inner wall of the concave portion to the bottom. By forming the concave surface into a curved surface without corners, insertion of a catheter or the like becomes easier, and the airtightness of the medical valve body is further improved. FIG. 7 is a plan view and a sectional view taken along line AA of another aspect of the medical valve body of the present invention.
In the medical valve body according to this aspect, the length of the slit extends from the upper surface toward the lower surface. The slit surface 8 to be expanded can reduce resistance when inserting a catheter or the like. In the medical valve body of the present invention, the position of the slit surface is not particularly limited and can be arbitrarily selected, but it is preferably a surface passing through the center of the disc shape. FIG. 8: is a top view which shows the aspect of the cut surface of the slit surface of the medical valve body of this invention. When the medical valve body of the present invention is viewed from above, the slit surface is observed as a line of the cut surface, and the cut surface of the slit surface is the one-letter shape shown in FIG.
8C, the cross shape shown in FIGS. 2 to 7, the large character shape shown in FIG. 8C, or the American character shape shown in FIG. 8D.

The medical valve body of the present invention is made of an elastic body. The elastic body to be used has a Shore hardness of 20 to 6
0A is preferable, and Shore hardness is 30 to 50A.
Is more preferable. Examples of such elastic body include silicone rubber, polyurethane, natural rubber,
Examples thereof include polybutadiene, ethylene oxide-propylene oxide copolymer, fluororubber, styrene-butadiene copolymer, polyethylene and polypropylene. The medical valve body of the present invention is such that the valve body is impregnated with silicone oil or the like in order to improve sliding of a catheter or the like that pushes the slit wide to insert, or the surface of the valve body, preferably the upper surface and the slit surface are It is preferable to coat with a hydrophilic polymer such as polyvinylpyrrolidone, polyacrylic acid, or cellulose. The medical valve body of the present invention usually has a thickness between the upper surface and the lower surface of 0.5 to 5 mm,
The diameter is 5 to 20 mm. The medical valve body of the present invention is a medical device composed of a tubular body, for example, a catheter for IABP method, a catheter for PTCA method, a catheter for TDC method,
It can be used for medical insertion aids (introducers), cannulas, etc., but is particularly suitable for medical insertion aids (introducers).

The medical insertion aid of the present invention is a medical insertion device in which a medical valve body made of a disc-shaped elastic body having a slit penetrating from a concave upper surface to a convex lower surface is fixedly mounted on a wall surface of an inner cavity. It is an auxiliary tool. There is no particular limitation on the method for fixing and mounting the medical valve body on the wall surface of the inner cavity, and for example, the side surface of the medical valve body can be inserted and clamped into the concave clamping portion provided on the inner wall to be fixedly mounted. The side face of the medical insertion aid can be fixedly mounted by being sandwiched by an annular cap, or the side face of the medical insertion aid can be fixedly mounted by being tightened with a housing or a squeezing tool of the medical insertion aid. The method of inserting and holding the side surface of the medical valve body into the concave holding portion provided on the inner wall so as to be fixedly mounted is easy to operate and can be reliably fixedly mounted, and thus can be particularly preferably used. . If necessary, the contact surface between the side surface of the medical valve body and the wall surface of the inner cavity of the medical insertion aid can be adhered or welded. FIG.
FIG. 3 is a cross-sectional view of an aspect of the medical insertion aid of the present invention.
In this embodiment, the side surface of the medical valve body 11 is sandwiched and fixedly mounted on the concave sandwiching portion 10 provided on the wall surface of the inner cavity of the sheath hub 9 of the medical insertion aid. The medical valve body shown in this figure is the medical valve body of the embodiment shown in FIG. The sheath 12 is fixedly attached to the sheath hub by a fixture 13. The sheath hub includes a branch pipe 14. In this figure, the catheter 15 is inserted through the medical valve body 11. Since the medical valve body portion is hermetically sealed, there is no risk of blood flowing out from the body lumen. FIG.
It is a partially broken view which shows other one aspect | mode of the medical insertion assistance tool of this invention. In the present aspect, the two annular caps 16 are provided on the wall surface of the lumen of the sheath hub 10 of the medical insertion aid,
The medical valve body 11 is fixedly mounted by sandwiching it between the upper surface and the lower surface. The medical valve body shown in the figure is a medical valve body having a slit cross-shaped slit. The sheath 12 is fixedly attached to the sheath hub by a fixture 13. In this figure, the catheter 15 is inserted through the medical valve body 11. Since the medical valve body portion is hermetically sealed, there is no risk of blood flowing out from the body lumen. In order to maximize the hemostatic function of the medical valve body of the present invention, it is preferable to mount a medical valve body having an outer diameter larger than the inner diameter of the mounting portion of the medical valve body in the lumen of the medical insertion aid. . By making the outer diameter of the medical valve body larger than the inner diameter of the mounting portion of the inner cavity, the medical valve body is pressed by the mounting portion of the inner cavity and the surfaces of the slits are strongly crimped, so that the hemostatic function is enhanced.

[0009]

EXAMPLES The present invention will be described in more detail with reference to the following Examples, which should not be construed as limiting the present invention. Example 1 The upper surface is a mortar-shaped concave surface, and the lower surface is a disk shape having a conical convex surface. The disk penetrates from the upper surface to the lower surface, and the length extends from the upper surface to the lower surface. A passage resistance measurement test was performed using a medical valve body having a slit-like shape and a cup-shaped pocket portion provided at the center of the slit. The material of the medical valve body is silicone rubber having a Shore hardness of 40A. The outer diameter of the medical valve body is 8.0mm and the thickness is 2.5.
mm. The length of the cross of the cross-shaped slit is 2.8 mm on the upper surface and 4.6 mm on the lower surface. The entire medical valve body was impregnated with silicone oil, and then, as shown in a partially broken view of FIG. 10, it was clamped and fixedly mounted on a sheath hub of a medical insertion aid having an inner diameter of 7.5 mm by two annular caps. FIG. 11 is an explanatory diagram showing a measurement test method. The medical valve body fixedly attached to the medical insertion aid has a thickness of 5
A Fr polyurethane round bar 17 was inserted by pushing the slit open, a spring balance 18 was attached to the tip, and the round bar was pulled axially at 150 mm / sec by the spring balance to pull out the round bar from the medical valve body. The indicated value of the spring balance from the start of pulling the round bar to the pulling out was 83 gf. Example 2 Except that the pocket portion is formed by a convex curved surface without corners,
Using the medical valve element having the same shape and material as in Example 1, Example 1
The exact same operation was repeated. The indicated value of the spring balance from the start of pulling the polyurethane round bar to the pulling out was 76 gf. Comparative Example 1 A medical valve element having the same shape and material as in Example 1 was used except that the lower surface was a flat surface, and the same operation as in Example 1 was repeated. The indicated value of the spring balance from the start of pulling the polyurethane round bar to the pulling out was 100 gf.
From the results of Examples 1 and 2 and Comparative Example 1, it can be seen that the insertion resistance of the round bar is reduced by using the medical valve body made of the disc-shaped elastic body whose lower surface is a convex surface. Further, it can be seen that the insertion resistance is further reduced by forming the pocket portion provided in the central portion of the slit on the upper surface from a cup shape to a curved surface without corners.

[0010]

According to the medical valve body and the medical insertion aid of the present invention, since the medical valve body is not deformed when the catheter or the like is inserted into the living body lumen through the slit, the insertion resistance is low,
Moreover, it is possible to reliably prevent leakage of body fluid from the body lumen.

[Brief description of drawings]

FIG. 1 is a plan view and a sectional view of a conventional medical valve body.

FIG. 2 is a plan view and a cross-sectional view of one aspect of the medical valve body of the present invention.

FIG. 3 is a plan view and a cross-sectional view of another aspect of the medical valve body according to the present invention.

FIG. 4 is a plan view and a cross-sectional view of another aspect of the medical valve body of the present invention.

FIG. 5 is a plan view and a cross-sectional view of another aspect of the medical valve body of the present invention.

FIG. 6 is a plan view and a cross-sectional view of another aspect of the medical valve body of the present invention.

FIG. 7 is a plan view and a cross-sectional view of another aspect of the medical valve body of the present invention.

FIG. 8 is a plan view showing an aspect of a cut surface of a slit surface of the medical valve body of the present invention.

FIG. 9 is a cross-sectional view of one aspect of the medical insertion aid according to the present invention.

FIG. 10 is a partially cutaway view of another aspect of the medical insertion assisting tool of the present invention.

FIG. 11 is an explanatory diagram showing a method for measuring and measuring a passage resistance.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Disk-shaped elastic body 2 Upper surface 3 Lower surface 4 Slit 5 Conical lower surface 6 Mortar-shaped upper surface 7 Pocket portion 8 Expanding slit surface 9 Sheath hub 10 Recessed holding portion 11 Medical valve body 12 Sheath 13 Fixture 14 Branch pipe 15 Catheter 16 Annular Cap 17 Round Bar 18 Spring Scale

Claims (2)

[Claims] 1. A medical valve body comprising a disc-shaped elastic body having a slit penetrating from an upper surface to a lower surface, wherein the upper surface is a concave surface and the lower surface is a convex surface. Medical valve body fixedly attached to the. 2. A medical insertion aid having an inner cavity, wherein the medical valve element according to claim 1 is fixedly mounted on the wall surface of the inner cavity.