JPH10328308A - Medical valve body and medical insertion aid - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical valve body and a medical insertion aid which achieve excellent operability by assuring a better hematostatic property in both conditions before and during the insertion of a long-sized object such as catheter and moreover, by reducing the resistance during the insertion and the passage of the insertion object. SOLUTION: An elastic body 40 of a valve is arranged to form a tight hole 46 which allows inserting of a long-sized insertion object being kept liquid tight piercing the body 40 of the valve from the upper surface 41 to the lower surface 43 thereof. A resistance easing groove 60 deep across the thickness of the body 40 of the valve is formed in the underside 43 of the body 40 of the valve to be positioned on the perimeter of the tight hole 46.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical valve and a medical insertion aid, and more particularly, to hemostasis both before and during insertion of a long insert such as a catheter. TECHNICAL FIELD The present invention relates to a medical valve element and a medical insertion aid which are excellent in operability and have low operability with low resistance when inserting and passing an insert.

[0002]

2. Description of the Related Art An intra-aortic balloon pumping method (so-called IAB) used for treatment of cardiac function deterioration such as heart failure.
P method), a method of percutaneous coronary angioplasty (so-called PTCA) used for treatments such as expanding blood vessels around the heart.
In a therapeutic or diagnostic method such as a thermodilution catheter method (so-called TDC method) used for measuring the blood flow rate of the heart, a catheter tube is inserted into an arteriovenous blood vessel of a patient. In order to insert such a catheter tube into a blood vessel of a patient, a medical insertion aid (for example, an introducer) is used.

[0003] The introducer has a sheath in which a through hole is formed. A needle-shaped dilator is inserted into the sheath as necessary, and in this state, the distal end of the dilator is inserted into the blood vessel of the patient, and the insertion port of the blood vessel is spread by the dilator. Thereafter, the dilator is withdrawn from the proximal end of the sheath. The distal end of the sheath remains inserted into the insertion port of the blood vessel. Thereafter, the catheter tube is introduced into the blood vessel through the inner hole of the sheath.

[0004] In such an introducer, a medical valve body is mounted on the proximal end side of the sheath, and after the dilator is removed from the sheath and before the catheter tube is inserted, the medical valve is inserted from the patient's blood vessel. Prevents blood from leaking through the sheath. This medical valve element is required to exhibit a hemostatic effect both while the dilator is inserted into the sheath and during insertion of the catheter tube into the blood vessel through the sheath.

As a medical valve element mounted in a sheath, as shown in FIG. 8, an elastic disc-shaped valve element 3 having a close contact hole 1 formed of a slit is known.

However, in a conventional valve body, when a catheter or a guide wire is inserted into the valve body, the valve body is easily pushed and deformed in the insertion direction, and the resistance when inserting a catheter or the like becomes high. It may not be easy to insert a catheter or the like.

In order to solve such a problem, the applicant has already reported a medical valve element suitable for a medical insertion aid (for example, JP-A-9-47511, JP-A-9-475).
No. 12).

[0008]

However, the balance between hemostasis, especially when a long insert is inserted, and low resistance during insertion and passage of the insert is further improved, and operation is improved. It was desired to enhance the character.

The present invention has been made in view of such circumstances, and has good hemostasis both in a state before inserting a long insert such as a catheter and in a state during insertion.
Moreover, it is an object of the present invention to provide a medical valve body and a medical insertion aid which are excellent in operability with low resistance during insertion and insertion of an insert.

[0010]

In order to achieve the above-mentioned object, a medical valve element according to the present invention maintains a liquid insert so that a long insert penetrates from an upper surface to a lower surface of a valve body. And a resilient valve body formed with a contact hole that can be inserted while being inserted. The lower surface of the valve body has a depth in the thickness direction of the valve body so as to be located around the contact hole. It is characterized in that a resistance relaxation groove is formed.

In the present invention, the shape of the valve body is not particularly limited, but is preferably a disk shape. The outer diameter b0 of the valve body (the diameter of a circumscribed circle when the valve body is other than a disk) is not particularly limited, but is preferably about 5 to 20 mm because it is used for medical purposes. The thickness t0 of the valve body is not particularly limited, but is preferably about 0.5 to 10 mm from the viewpoint that hemostasis and low resistance are required.

In the present invention, the structure of the contact hole is not particularly limited, but is preferably a composite structure of a through hole and a slit. With the composite structure of the through hole and the slit as described above, hemostasis is good both in a state before inserting a long insert such as a catheter and in a state during insertion.

The through hole is preferably formed on the upper surface of the valve body, and the slit is preferably formed on the lower surface of the valve body. The depth t1 of the through hole is preferably about 0.05 × t0 to 0.5 × t0, where t0 is the thickness of the valve body. The groove depth t2 of the slit is t0-t1.

The shape of the slit is not particularly limited.
Examples include a “−” shape, a “+” shape, a “Y” shape, and other shapes. More preferably, the cut cross section of the slit is divergent toward the lower surface of the valve body.
The pressure of the body fluid such as blood to be leaked acts on the slit from the wide cut cross-sectional side to the narrow cut cross-sectional side, and closes the gap between the slit and the insert (eg, dilator) at the narrow cut cross-sectional side. This is because the hemostatic property is kept good.

The inner diameter b1 of the through-hole is not particularly limited, but is preferably designed to be smaller than the outer diameter of the long insert (generally, the diameter of the guide wire, the diameter of the catheter used, or the diameter of the dilator). , Specifically, 0.
It is preferably about 1 to 4.0 mm. Further, it is preferable that the cut width b2 of the slit is about 1 to 5 times the inner diameter b1 of the through hole.

In the present invention, the resistance relaxation groove may be provided continuously along the circumferential direction of the valve body, or may be provided intermittently. Further, the cross-sectional shape of the resistance relaxation groove is not particularly limited, a semicircular shape, an elliptical shape, a triangular shape, a square shape,
Examples include a polygonal shape.

The groove width b3 of the resistance relaxing groove is not particularly limited, but is 0.02 × b0, where b0 is the outer diameter of the valve body.
It is preferably about 0.45 × b0. If the groove width is too small, there is no point in providing the groove, and if it is too large, the strength of the valve body tends to be insufficient, which is not preferable. Also,
The depth t3 of the resistance relaxation groove is preferably about 0.03 × t0 to 0.70 × t0, where t0 is the thickness of the valve body.
If the groove depth is too small, the effect of providing the groove is lost, and if it is too large, the strength of the valve body tends to be insufficient, which is not preferable. The formation position of the resistance relaxation groove is the lower surface position of the valve body and the outer peripheral position of the close contact hole formed by the through hole and the slit. The distance b4 between the maximum outer diameter position of the contact hole and the inner peripheral position of the resistance relaxation groove is not particularly limited, but is preferably 0.1 to 5 mm. If the distance b4 is too large, the effect of providing the groove tends to decrease, which is not preferable.

In the present invention, it is preferable that a leg portion extending in an axial direction is formed on an outer peripheral portion of a lower surface of the valve body so as to be located around the resistance relaxation groove. The leg may be provided continuously along the circumferential direction of the valve body,
It may be provided intermittently. The axial height t4 of the leg is preferably about 0.2 × t0 to 0.8 × t0, where t0 is the thickness of the valve body. The radial width b5 of the leg is preferably about 0.1 × b0 to 0.4 × b0, where b0 is the outer diameter of the valve body.

By forming the legs, it is possible to disperse the compressive force generated on the lower surface side of the valve body when inserting and passing the insert. As a result, the resistance at the time of inserting and passing the insert can be further reduced.

A medical insertion aid according to the present invention includes the medical valve body and a sheath for holding the medical valve body. An example of the medical insertion aid is an introducer for inserting a long insert such as a catheter tube into a blood vessel through a sheath.

[0021]

When an elongated insert such as a catheter tube is inserted into the close contact hole of the medical valve, the upper surface of the valve body is extended and the lower surface is compressed. For this reason, in the conventional medical valve body, the resistance at the time of inserting and passing the long insert into the close contact hole of the medical valve body has increased due to the compressive force generated on the lower surface side of the valve body.

In the medical valve element according to the present invention, a resistance relaxation groove having a depth in the thickness direction of the valve body is formed on the lower surface of the valve body so as to be located around the contact hole. The compressive force generated on the lower surface side of the main body is absorbed by the resistance relaxation groove. As a result, according to the present invention, it is possible to reduce the resistance when the insert is inserted and when the insert is passed.

In the medical insertion aid according to the present invention, a long insert such as a catheter tube can be easily inserted into a body cavity such as a blood vessel, and the resistance when the insert is inserted and when it passes therethrough is small. Therefore, operability is improved. Therefore, the burden on the doctor who operates the medical insertion aid according to the present invention is reduced, and at the same time the burden on the patient is reduced.

[0024]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below based on embodiments shown in the drawings.

FIGS. 1A to 1D are a perspective view, a plan view, a cross-sectional view, and a rear view of a medical valve element according to an embodiment of the present invention, and FIG. 2 shows the medical valve element shown in FIG. Sectional views of the medical insertion aid used, FIGS. 3 to 5 are schematic diagrams showing the usage state of the medical insertion aid, and FIGS. 6A to 6D are medical treatments according to other embodiments of the present invention, respectively. Sectional view of valve body for use, FIG.
(A)-(D) are a perspective view, a plan view, a sectional view, and a rear view of a medical valve element according to still another embodiment of the present invention.

First Embodiment A medical valve element 40 according to the present embodiment shown in FIG. 1 is mounted, for example, on the base end of an introducer 6 as a medical insertion aid shown in FIG. The introducer 6 is used in combination with the dilator 4, as shown in FIGS.

First, the dilator 4 and the introducer 6
Will be described briefly.

The dilator 4 is, as shown in FIGS.
A dilator body 8 having a tapered tip 8a for expanding a blood vessel insertion opening;
And a cap portion 10 joined to the base end portion.

The dilator body 8 is, as shown in FIG.
It is formed of a hollow tube, and has a guide wire insertion hole 8b formed therein. This dilator body 8
A dilator hub 12 and a cap 1
0 is bonded by means such as adhesion or fusion. The dilator body 8 is made of, for example, a tube made of fluororesin, polyamide, or polyethylene, and has an inner diameter of, for example, 0.5 to 2.0 mm and a wall thickness of, for example, 0.1 to 2.0 mm.

As shown in FIG. 3, the introducer 6 has a sheath 14 inserted so that the distal end 8a of the dilator main body 8 protrudes, and a sheath hub 16 joined to the base end of the sheath 14. . Sheath 14
As shown in FIG. 2, is constituted by a hollow tube, into which a dilator body 8 is inserted. The length of the sheath 14 is designed such that the tapered tip 8a of the dilator body 8 protrudes from its tip.

The sheath 14 is made of, for example, a tube made of fluororesin, polyurethane, or polyamide, and has an inner diameter of, for example, 1.0 to 5.0 mm and a thickness of, for example, 1.0 to 5.0 mm.
For example, it is 0.1 to 1.0 mm.

A sheath hub 16 is joined to the proximal end of the sheath 14 by means such as adhesion or fusion.
A luer tube 20 is connected to the sheath hub 16. The luer tube 20 communicates with a gap between the sheath 14 and the dilator main body 8, and through this luer tube 20, it is possible to perform suction of blood, injection of a drug solution such as heparin, or physiological saline.

The sheath hub 16 is, as shown in FIG.
It is detachably fittable into a fitting space 22 formed inside the cap portion 10. Moreover, in the present embodiment, a ring-shaped engaging convex portion 24 is formed on the outer periphery of the sheath hub portion 16, and an engaging concave portion 26 engaging with the engaging convex portion 24 is formed on the inner periphery of the cap portion 10. It is formed.

The projecting height of the engaging projection 24 is not particularly limited.
It is preferably about 16% larger. The groove depth of the engaging concave portion 26 is designed so that the projection of the engaging convex portion 24 is engaged.

The outer diameter a of the sheath hub portion 16 is equal to or more than the inner diameter b of the cap portion 10, preferably 3% or more.
Preferably it is 7% larger. The inner diameter b of the cap portion 10 is obtained by fitting the sheath hub portion 16 into the cap portion 10.
However, this is because the cap portion 10 and the sheath hub portion 16 are surely integrated, and these are hardly detached.

In the present embodiment, the cap 10 preferably has a Shore hardness of 90 A or less, more preferably 85 A or less.
It is made of a soft synthetic resin or an elastomer of A to 70A, and specifically made of polyurethane or polyvinyl chloride (PVC), nylon, natural rubber, styrene-based elastomer, or the like. In addition, the sheath hub 16 is
It is composed of a hard synthetic resin having a flexural modulus of 5,000 to 30,000 kg / cm2. Specifically, ABS, polyvinyl chloride (PVC), polyacetal, polyacrylonitrile, nylon, polyethylene (PE), polycarbonate (PC) Or polypropylene (PP) or the like.

As shown in FIG. 2, a medical valve element 40 is mounted inside the proximal end of the sheath hub 16 of the introducer 6 according to the present embodiment. In this embodiment,
As shown in FIGS. 1A to 1D, the medical valve body 40
At the center thereof, there is a valve body in which a close insertion hole 46 is formed in which a long insert such as the dilator 4 can be inserted while maintaining liquid tightness. In the present embodiment, the contact hole 46 includes a through hole 48 formed on the upper surface 41 side of the valve body 40 and a slit 50 formed on the lower surface 43 side.

In this embodiment, the slit 50 is a cross-shaped slit. The upper part of the slit 50 has the through hole 4
8, and the cut width b2 of the slit 50 is about 1 to 5 times the inner diameter b1 of the through hole 48.

The inner diameter of the through hole 48 is determined by the outer diameter of the long insert inserted into the through hole 48 (generally, the diameter of the guide wire,
(Diameter of the catheter or dilator used) is preferably designed to be smaller, specifically, 0.1 to
It is about 4.0 mm.

The thickness t0 of the valve body constituting the valve body 40 is
Although not particularly limited, it is determined that the insertion of the long insert is performed smoothly and has an appropriate sealing property, and specifically, it is about 0.5 to 5.0 mm.

In the present embodiment, the depth t1 of the through hole 48 is 0.2 to 0.6 mm, and the depth t2 of the slit is t2.
Is t0-t1.

In the present embodiment, as shown in FIGS. 1C and 1D, the lower surface of the valve body 40 is positioned on the lower surface of the valve body 40 so as to be located around the slit 50 forming the contact hole 46. A resistance relaxation groove 60 having a depth in the thickness direction and continuous in the circumferential direction is formed. The groove width b3 of the resistance relaxation groove 60 is 0.2 to 1.0 mm in the present embodiment. If the groove width is too small, there is no point in providing the groove 60, and if it is too large, the strength of the valve body 40 tends to be insufficient, which is not preferable. In addition, the depth t3 of the resistance relaxation groove 60 is 0.1 to 0.5 mm in the present embodiment. If the groove depth is too small, the effect of providing the groove 60 is lost, and if too large, the strength of the valve body 40 tends to be insufficient, which is not preferable. The formation position of the resistance relaxation groove 60 is the outer peripheral position of the slit 50 as described above. Distance b4 between the maximum outer diameter position of slit 50 and the inner peripheral position of resistance relaxation groove 60
Is 0.1 to 1.5 mm in the present embodiment. If the distance b4 is too large, the effect of providing the groove 60 tends to decrease, which is not preferable.

In the present embodiment, the material of the valve body constituting the valve body 40 is not particularly limited.
It is composed of synthetic rubber such as butyl rubber, ethylene-propylene rubber, polybutadiene rubber, polyisoprene rubber, silicone rubber, polyurethane, and fluoro rubber, preferably silicone rubber. The through-hole 46, the slit 50, and the resistance relaxation groove 60 may be formed at the same time as the valve body is formed, or may be formed by machining after forming a disk-shaped formed body.

The medical valve body 40 thus formed
Is mounted, for example, inside the proximal end portion of the sheath hub 16 of the introducer 6 shown in FIG.

The insertion of a catheter tube into a blood vessel using the introducer 6 having the medical valve element 40 according to the present embodiment is performed as follows. First, a puncture needle composed of an outer trocar (cannula) and an inner trocar (not shown) is pierced from above the patient's skin 30 shown in FIG. 5, and the tip is positioned in the blood vessel 32. Next, the inner trocar is extracted while leaving the outer trocar (cannula), and the guide wire 34 is inserted into the blood vessel 32 from the hole from which the inner trocar has been extracted.

Next, the trocar is withdrawn along the inserted guide wire 34, and then the guide wire 34 is passed through the insertion hole 8b of the dilator body 8 shown in FIG. The distal end of the catheter tube insertion tool in which the transducer 6 and the dilator 4 are integrated is inserted into the insertion port 36 of the blood vessel. The state is shown in FIG.

In order to integrate the dilator 4 into the introducer 6, in the present embodiment, the dilator body 8 of the dilator 4 is inserted from the sheath hub 16 on the proximal end side of the introducer 6, and the tapered shape of the dilator body 8 is formed. The distal end portion 8a is projected from the distal end of the sheath 14.
Then, the cap 10 formed at the base end of the dilator 4 is attached to the outer periphery of the sheath hub 16 formed at the base end of the sheath 8. That is, the sheath hub portion 16
Is pushed into the inner periphery of the cap portion 10. As a result, as shown in FIG. 4, the engaging protrusions 24 formed on the outer periphery of the sheath hub 16 engage with the engaging recesses 26 formed on the inner periphery of the cap 10, and the introducer 6 The dilator 4 and the dilator 4 cannot move relative to each other in the axial direction and the rotational direction, and are integrated.

At this time, in this embodiment, the cap 1
0 is made of a soft synthetic resin, and the sheath hub portion 16
Are made of a hard synthetic resin, the fitting between them is strong, and they do not come off during the insertion operation.

As shown in FIG. 5, if the tip of the catheter tube insertion tool comprising the integrated introducer 6 and dilator 4 is inserted into the insertion port 36 of the blood vessel, a taper formed at the tip of the dilator 6 is obtained. The distal end portion 8a spreads the insertion port 36 of the blood vessel. Further, when the distal end of the catheter tube insertion tool is pushed in, the distal end of the sheath 14 is also inserted into the blood vessel.

Thereafter, the engagement between the engaging projection 24 and the engaging recess 26 is released by operating the proximal end of the catheter tube insertion tool and tilting the cap 10 with respect to the sheath hub 16, for example. The cap 10 is removed from the sheath hub 16. At this time, in the present embodiment, the cap 10 is
Since it is made of a soft synthetic resin, the engaging projection 24
It is also easy to release the engagement with the engagement recess 26.

Thereafter, the cap 10 is connected to the sheath hub 1.
When the guide wire 34 is pulled out from the base end side with respect to the guide wire 6, the dilator body 8 and the guide wire 34 are pulled out from the sheath 14. Thereafter, if a catheter tube is inserted into the introducer 6 from the proximal end side, the catheter tube is conveniently inserted into the blood vessel 32.

In this embodiment, since the contact hole 46 formed in the medical valve body 40 is a combination of the through hole 48 and the slit 50, the elongate body such as the dilator body 8 or the catheter tube is provided in the introducer 6. Even during the insertion of the insert, the blood flowing from the introducer tip side is well sealed by the medical valve element 40. That is, the through-hole 48 does not have hemostasis when the insert is not inserted into the through-hole 48, but maintains hemostasis when the insert is inserted into the through-hole 48.

When the dilator 4 is removed from the introducer 6 and nothing is inserted into the medical valve element 40, such as during the insertion of the catheter tube, the second
Since the slit 50 of the film body 44 is closed, a good hemostatic action is achieved.

Therefore, the medical valve element 40 and the introducer 6 having the same according to the present embodiment have good hemostasis both in a state before inserting a long insert such as a catheter and in a state during insertion. is there.

In addition, the medical valve element 40 according to the present embodiment
In the introducer 6 having the same, a resistance relaxation groove 60 having a depth in the thickness direction of the valve body 40 is formed on the lower surface of the valve body 40 so as to be located around the slit 50 forming the close contact hole 46. Therefore, the compressive force generated on the lower surface side of the valve body 40 is absorbed by the resistance relaxation groove 60. As a result, in the present embodiment, it is possible to reduce the resistance at the time of insertion and passage of an insert such as a catheter tube. Therefore, the burden on the doctor who operates the introducer 6 according to the present invention is reduced, and at the same time the burden on the patient is reduced.

It should be noted that the present invention is not limited to the above-described embodiment, but can be variously modified within the scope of the present invention. For example, the following embodiments are exemplified.

Second Embodiment This embodiment is a modification of the embodiment shown in FIG. 1, and the resistance relief groove is provided in the medical valve element 40a shown in FIG.
As shown in FIG.
In the medical valve element 40b shown in FIG. 8B, the resistance relief groove 60b has an acute triangular shape on the inside. Note that the shape of the resistance relaxation groove is not limited to these, but may be another cross-sectional shape. In addition, they may not be formed continuously in the circumferential direction, but may be formed intermittently.

The medical valve element 40 according to such an embodiment
The a and b also have the same operational effects as the medical valve of the first embodiment.

Third Embodiment As shown in FIG. 6 (C), a medical valve element 40c according to this embodiment is a modification of the embodiment shown in FIG. 1, and a slit 50c is provided on the lower surface of the valve element 40c. It has a cut section that widens toward the end. The upper portion of the slit 50c can communicate with the through hole 48, and the cut width of the slit 50c on the through hole side has an outer diameter substantially equal to the inner diameter b1 of the through hole 48. The cut width b2 on the lower surface side of the slit 50c is about 1 to 5 times the inner diameter b1 of the through hole 48.

The medical valve body 40 according to such an embodiment
In (c), in addition to having the same functions and effects as those of the medical valve body 40 of the first embodiment, the following functions and effects are also provided. That is, in the present embodiment, by making the cut cross section of the slit 50c divergent toward the lower surface of the valve element 40c,
The pressure of the body fluid such as blood to be leaked is
c acts on the narrow cut cross-sectional side from the wide cut cross-sectional side, and closes the gap between the slit 50c and the insert (for example, the dilator 4) on the narrow cut cross-sectional side, thereby maintaining good hemostasis.

Fourth Embodiment As shown in FIG. 6D, a medical valve element 40d according to this embodiment is a modification of the embodiment shown in FIG.
A leg portion 54 extending in the axial direction is formed on the outer peripheral portion of the lower surface of the valve element 40d so as to be located around the resistance relaxation groove 60.
The leg portion 54 may be provided continuously along the circumferential direction of the valve body 40d, or may be provided intermittently. The axial height t4 of the leg portion 54 is about 0.5 to 8 mm in the present embodiment. The radial width b5 of the leg 54 is about 0.5 to 10 mm in the present embodiment.

In the medical valve element 40d according to this embodiment,
In addition to having the same functions and effects as those of the medical valve body 40c of the third embodiment, the following functions and effects are also provided. That is,
By forming the legs 54, it is possible to disperse the compressive force generated on the lower surface side of the valve element 40d when inserting and passing the insert. As a result, the resistance at the time of inserting and passing the insert can be further reduced.

Fifth Embodiment As shown in FIGS. 7A to 7D, a medical valve element 40e according to this embodiment is a modification of the embodiment shown in FIG. From the first layer 42 and the second layer 44
Adhesion holes 46e are formed at the center of the material so that a long insert such as the dilator 4 can be inserted while maintaining liquid tightness. In the present embodiment, the contact hole 46e is formed by a through hole 48e formed in the first layer 42,
And a slit 50e formed in the second layer 44. A tapered inclined surface 52 is formed on the upper surface 41 side of the through hole 48e to guide insertion of the dilator 4 and the like.

The first layer 42 is mounted so as to be located on the insertion surface side of an insert such as the dilator 4.
The material 2 is made of a material having a large tear strength and a large elongation. The material of the second layer 44 laminated below the first layer 42 is made of a material having high elasticity and low permanent strain.

The tear strength of the first layer 42 is preferably 20 to 60 kgf / cm, more preferably 30 to 60 kgf / cm.
It is 60 kgf / cm. The elongation of the first layer 42 is
Preferably 400-1200%, more preferably 60%
0 to 1200%. The rebound resilience of the second layer 44 is preferably 40 to 90%, more preferably 50 to 90%.
90%. Further, the compression set of the second layer 44 is preferably 30% or less, more preferably 20% or less. The tear strength, elongation, rebound resilience and compression set are:
It is measured according to JIS K6301.

When the tear strength is 20 kgf / cm or less, the valve is easily cracked and the durability is poor. When the elongation is 400% or less, the elongation is small, so that it becomes difficult to insert a thick (large diameter) catheter. Not preferred. On the other hand, if the rebound resilience is 40% or less and the compression set is 30% or more, the valve contact hole after removal of the catheter is not instantaneously closed and the hemostasis is poor, which is not preferable.

In this embodiment, the first layer 42 and the second layer 44 are made of different silicone rubbers having the above-mentioned properties.

In this embodiment, the first layer 42 and the second layer
After the layers 44 and 44 are separately formed, or simultaneously, a through hole 48e, a tapered inclined surface 52, and a slit 50e are formed in each layer, and these are compression-molded and heat-pressed. In addition, the contact hole 46 including the through hole 48e, the tapered inclined surface 52, and the slit 50e may be formed after the first layer 42 and the second layer are pressed. Also, the first layer 42
The second layer 44 may be joined with an adhesive. As the adhesive, for example, RTV silicone, cyanoacrylate, or the like is used. Furthermore, the first layer 42 and the second
The layers may be simply placed one on top of the other without complete bonding.

The other structure is the same as that of the embodiment shown in FIG. The shape and size of the resistance relaxation groove 60 are the same as those in the embodiment shown in FIG.

In the medical valve element 40e according to the present embodiment,
In addition to having the same functions and effects as those of the medical valve body 40c of the third embodiment, the following functions and effects are also provided.

That is, the medical valve element 4 according to the present embodiment.
0e and the introducer 6 having the same, since the material of the first layer 42 located on the insertion surface side of the long insert such as the catheter tube is made of a material having a large tear strength and a large elongation, it is long. The insert has good insertion characteristics, and no cracks or the like occur in the contact hole 46 even when repeatedly inserted and removed. That is, it has excellent durability. Further, since the layer 44 (at least one layer in the case of a multilayer structure) on the side opposite to the insertion-side surface layer of the valve element 40e is made of a material having high elasticity and low permanent strain, the length of the catheter tube or the like is long. After removing the scale insert from the valve body 40e, the contact hole 46e is instantly closed, and the hemostatic property is excellent.

[0072]

EXAMPLES Hereinafter, the present invention will be described based on more detailed examples, but the present invention is not limited to these examples.

Example 1 A disc-shaped valve element 40c having a sectional shape shown in FIG. 6C was prepared. The material of the valve body 40c was a silicone rubber having a Shore hardness of 45A. The outer diameter b0 of the valve element 40c is 8 mm,
The thickness t0 is 1.5 mm, and the inner diameter b1 of the through hole 48 is 0.7 m.
m, the cut width b2 on the lower surface side of the slit 50c is 2.5m
m, the depth t1 of the through hole 48 is 0.5 mm, the cut depth t2 of the slit is 1.0 mm, the groove width b3 of the resistance relaxation groove 60 is 0.5 mm, the groove depth t3 is 0.25 mm, and the slit 50
The distance b4 between the outer edge position and the inner diameter position of the resistance relaxation groove 60 was 0.5 mm.

This medical valve body 40c was mounted in the sheath hub 16 of the introducer 6 shown in FIG. A tube made of polyamide having an outer diameter of 2.7 mm is inserted into the sheath hub 16, the tube tip is inserted into the sheath hub 16 after insertion (resistance to insertion), and the tube is further fed into the sheath hub 16 after insertion. The resistance when the tube passed (pass resistance) was measured. Insertion resistance is 7
It was 8 gf and the passage resistance was 95 gf.

The tube is connected to the contact hole 46 of the valve body 40c.
c, 200 m into the sheath hub 16.
Although mHg pseudo blood was introduced, there was no leakage from the contact hole. Further, when leakage of the pseudo blood from the close contact hole of the medical valve body after the tube was removed was examined, there was no leakage.

Embodiment 2 As shown in FIG. 6D, a valve body 40d having a leg 54
Was prepared. The width b5 of the leg 54 is 1.75 mm, and the leg 54
Of the valve body was 1.6 mm, and the thickness t0 of the valve body was 1.4 mm. Other dimensions were the same as in Example 1. When the insertion resistance and the passing resistance were examined in the same manner as in Example 1, the insertion resistance was 69 gf and the passing resistance was 86 g.
f. A decrease in insertion resistance and passage resistance was observed more than in Example 1.

[0077] Except that does not form a Comparative Example 1 resistance relaxation groove 60 was prepared the same valve body as in Example 1, in the same manner as in Example 1, were examined insertion resistance and flow resistance.

The insertion resistance is 98 gf and the passing resistance is 1
It was 18 gf. Compared with Examples 1 and 2, an increase in insertion resistance and passage resistance was observed.

[0079]

As described above, according to the present invention, hemostasis is good both in a state before inserting a long insert such as a catheter and in a state during insertion.
In addition, it is possible to provide a medical valve body and a medical insertion aid having excellent operability with low resistance during insertion and insertion of the insert.

[Brief description of the drawings]

FIGS. 1A to 1D are a perspective view, a plan view, a cross-sectional view, and a rear view of a medical valve element according to an embodiment of the present invention.

FIG. 2 is a sectional view of a medical insertion aid using the medical valve element shown in FIG. 1;

FIG. 3 is a schematic view showing a use state of the medical insertion aid.

FIG. 4 is a schematic view showing a use state of the medical insertion aid.

FIG. 5 is a schematic view showing a use state of the medical insertion aid.

FIGS. 6A to 6D are cross-sectional views of a medical valve body according to another embodiment of the present invention.

FIGS. 7A to 7D are a perspective view, a plan view, a cross-sectional view, and a rear view of a medical valve element according to still another embodiment of the present invention.

FIG. 8 is a perspective view of a main part showing a use state of a medical valve element according to a conventional example.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 4 ... Dilator 6 ... Introducer (medical insertion auxiliary tool) 8 ... Dilator main body 8a ... Tapered tip part 10 ... Cap part 14 ... Sheath 16 ... Sheath hub part 40, 40a-40e ... Medical valve element 41 ... Top surface 42 ... First layer 43 Lower surface 44 Second layer 46 Adhesive hole 48 Through hole 50, 50c, 50e Slit 54 Leg 60, 60a, 60b Resistance relaxation groove

Claims (2)

[Claims] 1. A resilient valve body having a contact hole through which a long insert can be inserted while maintaining liquid tightness so as to penetrate from the upper surface to the lower surface of the valve body. A medical valve body in which a resistance relaxation groove having a depth in a thickness direction of the valve body is formed on a lower surface of the valve body so as to be located around a contact hole. 2. A medical insertion aid comprising the medical valve element according to claim 1, and a sheath for holding the medical valve element.