JPH10127775A - Medical valve and medical insertion aid - Google Patents

Abstract

(57) [Summary] [PROBLEMS] When inserting a long insert such as a catheter, a contact hole is easily opened, and after removing the insert,
To provide a medical valve body and a medical insertion aid having excellent durability in which a close contact hole is instantly closed and a crack or the like does not enter even when an insert is repeatedly inserted and removed. SOLUTION: This is a medical valve body 40 formed with a contact hole 46 into which a long insert such as a catheter tube can be inserted while maintaining the liquid tightness, wherein the medical valve body 40 has a first layer 42 and a second layer 42. Layer 4
4, the first layer 42 located on the insertion side surface of the long insert is made of a material having a large tear strength and a large elongation. The material of the layer 44 is made of a material having high elasticity and low permanent set.

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 a method for inserting a long insert such as a catheter, in which a contact hole is easily opened and the insert is removed. The present invention relates to a highly durable medical valve body and a medical insertion aid which can be closed immediately after the insertion, so that a crack or the like does not enter even if the insert is repeatedly inserted and removed.

[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 patient's blood vessel, a medical insertion aid (introducer) is used.

[0003] The introducer has a sheath, and with the dilator inserted in the sheath, 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 Thereafter, the dilator is withdrawn from the proximal end of the sheath.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, a catheter tube is introduced into the blood vessel through the interior of the sheath.

[0004] In such an introducer, a medical valve body is mounted on the proximal end side of the sheath, and after extracting the dilator and inserting a catheter tube, blood is passed from the patient's blood vessel through the sheath. To prevent leakage. This medical valve element is required to exhibit a hemostatic effect both while the dilator is inserted into the sheath and while the catheter tube is inserted into the blood vessel through the sheath.

[0005] As a medical valve body mounted in the sheath,
As shown in FIG. 9, the contact hole 1 formed of a slit is provided.
Is known.

However, in the medical valve according to this conventional example, a long insert 7 such as a dilator, a catheter tube and a guide wire is inserted into a blood vessel through the close contact hole 1 formed in the valve 3. If the diameter of the insert is large, a gap 5 is formed at the end of the slit-shaped contact hole 1, and there is a possibility that a satisfactory hemostatic action cannot be performed.

Therefore, as disclosed in Japanese Patent Application Laid-Open Nos. 8-173586 and 8-15534, a valve element having a contact hole formed of a special slit or a contact element formed of a combination of a hole and a slit is disclosed. A valve body having a hole has been developed.

[0008]

By the way, in such a medical valve, it is necessary that the contact hole is easily opened when the catheter tube is inserted, and the contact hole is closed immediately after the catheter tube is removed. Yes (first request). In addition, since the catheter tube and the like are repeatedly inserted and removed, it is necessary to have a durability such that no crack is formed in the contact hole and the contact hole is not closed at this time (second requirement).

However, the medical valve element according to the conventional example as described above cannot satisfy these two requirements at the same time.

The present invention has been made in view of such circumstances, and when a long insert such as a catheter is inserted, the contact hole is easily opened, and after the insert is removed, the contact hole is instantly closed. It is another object of the present invention to provide a medical valve body and a medical insertion assisting device which are excellent in durability such that a crack or the like does not enter even if an insert is repeatedly inserted and removed.

[0011]

The present inventors have found that when a long insert such as a catheter is inserted, the contact hole is easily opened, and after the insert is removed, the contact hole is instantly closed. The present inventors have studied diligently a medical valve body which does not crack even after repeatedly inserting and removing the insert. As a result, the medical valve body is configured to have at least the first layer and the second layer, and the first layer located on the insertion surface side of the long insert is
Made of a material with high tear strength and high elongation,
It has been found that the above object can be achieved by forming the layer from a material having high elasticity and low permanent set, and the present invention has been completed based on this new finding.

That is, the medical valve element according to the present invention is a medical valve element having a contact hole through which a long insert can be inserted while maintaining liquid tightness, wherein the medical valve element is at least a first element.
A first layer located on the insertion side surface of the long insert, the first layer being made of a material having a large tear strength and a large elongation, and the second layer being It is made of a material having high elasticity and low permanent set.

The tear strength of the first layer is preferably from 20 to 60 kgf / cm, more preferably from 30 to 60 kgf / cm.
kgf / cm. The elongation of the first layer is preferably 400 to 1200%, more preferably 600 to 12%.
00%. The rebound resilience of the second layer is preferably 40 to 90%, more preferably 50 to 90%.
Further, the compression set of the second layer is preferably 30% or less, more preferably 20% or less.

The tear strength, elongation, rebound resilience and compression set are measured according to JIS K6301.

When the tear strength is 20 kgf / cm or less, the valve is apt to crack and the durability is inferior. When the elongation is 400% or less, since the elongation is small, it becomes difficult to insert a thick (large diameter) catheter. Not preferred. In addition, when the rebound resilience is 40% or less and the compression set is 30% or less, the valve contact hole after the catheter is removed does not close instantaneously, resulting in poor hemostasis, which is not preferable.

The specific material of the first layer and the second layer is not particularly limited. For example, synthetic rubbers such as natural rubber, butyl rubber, ethylene-propylene rubber, polybutadiene, polyisoprene, silicone rubber, polyurethane, and fluorine rubber are preferable. Composed of silicone rubber.

[0017] The medical valve element may include at least a first layer and a second layer.
It is preferable that the first layer is formed with a through hole serving as the upper half of the contact hole, and the second layer is formed with a slit serving as the lower half of the contact hole. Also, the first layer is
It can also be formed so as to be embedded in the center of the second layer. Further, the medical valve body may have a multilayer structure of three or more layers of the first layer, the second layer, and the first layer, or four or more layers of a combination thereof. Further, the medical valve body may be formed by laminating layers other than the first layer and the second layer.

The laminating method in the present invention is not particularly limited, but a thermocompression bonding method at the time of compression molding can be adopted.
Adhesion with an adhesive can also be employed. Further, they may simply be overlapped. Furthermore, a method in which a convex portion is provided on the joining surface of any one of the layers, a concave portion is provided on the joining surface of the other layer, and the convex portion and the concave portion are stacked so as to fit each other.

The contact hole provided in the medical valve body is preferably formed in each layer before lamination, but may be formed after the layers are laminated. The structure of the contact hole is not particularly limited, but is preferably a combination of a hole and a slit. In that case, it is preferable to form a hole on the first layer side which is the insertion surface side, and to form a slit on the second layer side which is the back side.

A medical insertion aid according to the present invention has the above-mentioned 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.

In the medical valve element according to the present invention, the material of the first layer located on the insertion surface side of the long insert (including the case of an intermediate layer when there are three or more layers) has a large tear strength. , It has good insertion characteristics for a long insert such as a catheter tube, and does not cause cracks or the like in the contact hole even if it is repeatedly inserted and removed. That is,
Has excellent durability. Further, the layer on the side opposite to the insertion-side surface layer of the valve body (at least one layer in the case of a multilayer structure)
Because it is composed of a material with high elasticity and low permanent distortion, after extracting a long insert such as a catheter tube from the valve body,
The contact hole closes instantly, providing excellent hemostasis.

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 further, hemostasis is improved, and a long insert such as a catheter tube is repeatedly used. Even if the insert is inserted and removed, the hemostasis does not deteriorate and the durability is excellent.

[0023]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a medical valve body and a medical insertion aid according to the present invention will be described in detail based on an embodiment shown in the drawings.

The perspective view of the medical valve body according to an embodiment of the first embodiment FIG. 1 (A) ~ (D) according to the present invention, a plan view, sectional view and a rear view, FIG. 2 FIG. 1
Sectional view of a medical insertion aid using the medical valve element shown in
3 to 5 are schematic diagrams showing the use state of the medical insertion aid.

As shown in FIG. 1, the medical valve element 40 according to the present embodiment is mounted on, for example, a proximal 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 a fluorine resin, 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 portion 8a of the dilator body 8 protrudes, and a sheath hub portion 16 joined to the base end portion 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 wall 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 greater than the inner diameter b of the cap portion 10, and is 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 of A to 70A, and specifically made of polyurethane or polyvinyl chloride (PVC), nylon, natural rubber, styrene-based elastomer, or the like. The sheath hub 16 has a flexural modulus of 5
3,000 to 30,000 kg / cm ² of hard synthetic resin. Specifically, ABS, polyvinyl chloride (PV)
C), polyacetal, polyacrylonitrile, nylon, polyethylene (PE), polycarbonate (P
C) or polypropylene (PP).

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 the present embodiment, as shown in FIGS. 1A to 1D, the medical valve body 40
Adhesion holes 46 are formed in the center of the two materials having a layer 42 and a second layer 44, through which a long insert such as the dilator 4 can be inserted while maintaining liquid tightness. I have. In the present embodiment, the contact hole 46 includes a through hole 48 formed in the first layer 42 and a slit 50 formed in the second layer 44. On the upper surface 40a side of the through hole 48,
A tapered inclined surface 52 is formed to guide the insertion of the dilator 4 and the like.

In the present embodiment, the slit 50 is a cross-shaped slit, and has a cut cross section that widens toward the lower surface 40 b of the valve element 40. The upper part of the slit 50
It is possible to communicate with the through hole 48 and the slit 5
The cut width b ₁ on the first layer side of 0 has an outer diameter that is substantially the same as the inner diameter of the through hole 48. Notch width b ₂ of the lower surface 40b side of the slit 50, to the upper notch width b _1, a size of about 1 to 5 times.

The shape of the slit 50 is not limited to the cross shape, but may be another shape, for example, a Y-shape. However, the cut section of the slit is the lower surface 40b of the valve body 40.
It is preferable that the divergence is widened toward. The pressure of the bodily fluid such as blood to be leaked acts on the slit 50 from the wide cut cross-sectional side to the narrow cut cross-sectional side, and the slit 50 and the insert (for example, the dilator 4) on the narrow cut cross-sectional side. This is because the gap is closed and the hemostatic property is kept good.

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 preferably about 4.0 mm.

The thickness t _{1 of} the first layer 42 and the second layer 44,
t ₂ is not particularly limited, the insertion of the elongated insert is performed smoothly, is determined to have a proper sealing property, specifically, each about 0.1~5.0mm are preferred.

As shown in FIG. 2, the first layer 42 is mounted so as to be located on the insertion surface side of the insert such as the dilator 4, and the material of the first layer 42 has a large tear strength and a large elongation. It is made of material. 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.

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 are separately formed, or at the same time, a through hole 48, a tapered inclined surface 52, and a slit 50 are formed in each layer, and these are compression-molded and heat-pressed. Note that the contact hole 46 including the through hole 48, the tapered inclined surface 52, and the slit 50 may be formed after the first layer 42 and the second layer are pressed. Further, the first layer 42 and the second layer 44 may be joined using an adhesive. As the adhesive, for example, RTV silicone, cyanoacrylate, or the like is used. Further, the first layer 42 and the second layer
Instead of being completely joined, they may simply be placed one on top of the other.

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 medical valve element 40 including the first layer 42 and the second layer 44 is mounted in the sheath hub portion 16 of the introducer 6, the dilator body 8 or the Even during insertion of a long insert such as a catheter tube, blood flowing from the distal end of the introducer is well sealed by the medical valve element 40. In particular, in the second layer 44, the blood pressure acts on the slit 50 from the wide cut cross-sectional side to the narrow cut cross-sectional side, and closes the gap between the slit 50 and the insert on the narrow cut cross-sectional side, thereby reducing the hemostatic property. Is kept good. The first layer 42 does not have hemostasis when the insert is not inserted into the through hole 48, but the hemostasis is improved by inserting the insert into the through hole 48.

When the dilator 4 is withdrawn from the introducer 6 and nothing is inserted into the medical valve body 40, such as before the catheter tube is inserted, the slit 50 of the second membrane body 44 closes. It has a good hemostatic effect.

In the medical valve element 40 and the introducer 6 having the same according to the present embodiment, the material of the first layer 42 located on the insertion surface side of the long insert such as a catheter tube is as follows.
Since it is made of a material having a high tear strength and a large elongation, the insertion characteristics of the long insert are good, 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 on the side opposite to the insertion side surface layer of the valve body 40 (at least one layer in the case of a multilayer structure) is made of a material having a high elasticity and a low permanent strain, a long tube such as a catheter tube is used. After removing the insert from the valve body 40, the contact hole 46 closes instantaneously, and is excellent in hemostasis.

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 As shown in FIG. 6, a medical valve element 40A according to the present embodiment comprises a first layer 42A and a second layer 44A, and a first layer 4A.
A ring-shaped concave portion 54 is formed on the joint surface of 2A,
A convex portion 56 formed on the joint surface of the second layer 44A is fitted into the concave portion 54 in an uneven manner, and these layers are integrated. Other configurations are the same as those of the medical valve body 40 of the first embodiment, and thus common members are denoted by common reference numerals and description thereof is omitted.

The medical valve element 40A according to the present embodiment also has the same operation as the medical valve element 40 according to the first embodiment.

Third Embodiment As shown in FIG. 8, a medical valve element 40B according to the present embodiment is composed of a first layer 42B and a second layer 44B, and a second layer 4B.
The first layer 42B is laminated so as to be embedded in a concave portion 45 formed at the center of 4B. The first layer 42B and the second layer
The layer 44B may be bonded with an adhesive, or may be heated and pressed during compression molding. Other configurations are the same as those of the medical valve body 40 of the first embodiment, and thus common members are denoted by common reference numerals and description thereof is omitted.

The operation of the medical valve element 40B according to the present embodiment is similar to that of the medical valve element 40 according to the first embodiment.

Fourth Embodiment As shown in FIG. 8, the medical valve element 40C according to the present embodiment has a three-layer structure of a first layer 42C, a second layer 44C, and a third layer 42C '. A through hole 48 and a tapered inclined surface 52 are formed in the center of the first layer 42C.
A slit 50 is provided at the center of the layer 44C and the third layer 42C '.
Is formed. The first layer 42C is the first layer 42C of the first embodiment.
The second layer 44C is made of the same material as the layer 42,
It is made of the same material as the second layer 44C of the first embodiment. In the present embodiment, the third layer 42C ′ is the first layer 42C.
It is made of the same material as. In the present invention, the third layer 42C 'may be made of a material different from any of the first layer 42C and the second layer 44C. Other configurations are the same as those of the medical valve body 40 of the first embodiment, and thus common members are denoted by common reference numerals and description thereof is omitted.

The medical valve element 40C according to the present embodiment also has the same operation as the medical valve element 40 according to the first embodiment.

Although the three-layer structure has been described in the above embodiment, the four-layer structure using the members of the first or second layer is described.
It may have a multi-layer structure of more than one layer, or may be formed as a structure of three or more layers using members other than the first layer or the second layer.

[0063]

Next, the present invention will be described based on a more concrete embodiment.

Example 1 The first layer 42 shown in FIG. 1 had a tear strength of 30 kgf /
cm, an elongation of 700%, a rebound resilience of 50%, and a compression set of 40%. The second layer 44
A silicone rubber having a tear strength of 20 kg, an elongation of 500%, a rebound resilience of 60%, and a compression set of 15% was used.

Each of these layers 42 and 44 has a structure shown in FIG.
The through hole 48 and the slit 50 shown in FIG. First
The thickness t _{1 of the} layer 42 is 1.0 mm, and the outer diameter is 8.0 mm.
And the inner diameter of the through hole 48 was 2.8 mm. The thickness t ₂ of the second layer 44 is 1.5 mm, the outer diameter is 8.0 mm, and the cut width b of the slit 50 on the first layer side is
₁ is 0.7 mm, cut width b ₂ of the lower surface 40b side was 3.0 mm.

The first layer 42 and the second layer 44 were thermocompression-bonded at the time of compression molding to produce a medical valve body 40. The medical valve body 40 was mounted in the sheath hub portion 16 of the introducer 6 shown in FIG. 2 so that the first layer 42 was located on the insertion side of the insert. The dilator body 8 having an outer diameter of 2.8 mm was inserted into the introducer 6, and the resistance at the time of insertion was 70 gf. Further, even if the dilator body 8 was repeatedly inserted and removed 20 times into the contact hole 46 of the valve body 40, no crack was generated in the contact hole.

Further, as shown in FIG. 2, 200 mmHg of pseudo blood was introduced into the sheath hub 16 with the dilator body 8 inserted through the close contact hole of the valve body 40. Did not. Further, when leakage of the pseudo blood from the medical valve body 40 after removing the dilator body 8 was examined, no leakage was found. This indicates that the contact hole 46 was closed immediately after the dilator body 8 was pulled out from the valve body 40.

Comparative Example 1 A medical valve element was manufactured in the same manner as in Example 1 except that the medical valve element 40 shown in FIG. Then, the same test as in Example 1 was performed.

That is, in the introducer 6 on which the medical valve body is mounted, a dilator body 8 having an outer diameter of 2.8 mm is provided.
Was inserted and the resistance at the time of insertion was measured.
Met. Further, even if the dilator body 8 was repeatedly inserted and removed 20 times into the contact hole 46 of the valve body 40, no crack was generated in the contact hole.

Further, as shown in FIG. 2, 200 mmHg of pseudo blood was introduced into the sheath hub 16 with the dilator body 8 inserted through the contact hole of the valve body 40. Did not. Further, when leakage of the pseudo blood from the medical valve body 40 after removing the dilator body 8 was examined, it was confirmed that leakage continued. It is considered that this is because the contact hole 46 did not close instantly after the dilator body 8 was pulled out from the valve body 40.

Comparative Example 2 A medical valve element was manufactured in the same manner as in Example 1 except that the medical valve element 40 shown in FIG. Then, the same test as in Example 1 was performed.

That is, the dilator body 8 having an outer diameter of 2.8 mm is placed in the introducer 6 on which the medical valve body is mounted.
When the resistance at the time of insertion was measured, 90 gf
It was confirmed that the insertion resistance was higher than that of Example 1. Further, when the dilator body 8 was repeatedly inserted into and removed from the contact hole 46 of the valve body 20 times, cracks were observed in the contact hole.

As shown in FIG. 2, when 200 mmHg of simulated blood was introduced into the sheath hub 16 in a state where the dilator body 8 was inserted through the contact hole of the valve body 40, it continued to leak from the contact hole. . This is considered to be due to a crack in the contact hole. Further, when leakage of the pseudo blood from the medical valve body 40 after removing the dilator body 8 was examined, no leakage was found.

[0074]

As described above, according to the medical valve element of the present invention, the material of the first layer located on the insertion surface side of the long insert is a material having a large tear strength and a large elongation. Since it is configured, the insertion characteristics of a long insert such as a catheter tube are good, and no cracks or the like occur in the contact hole even when it is repeatedly inserted and removed. That is, it has excellent durability. Further, since the layer on the side opposite to the insertion side surface layer of the valve body (at least one layer in the case of a multilayer structure) is made of a material having high elasticity and low permanent distortion, a long insert such as a catheter tube is used. After the valve is removed from the valve body, the contact hole closes instantaneously and is excellent in hemostasis.

According to 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 hemostasis is improved. Even if you insert and remove the long insert,
It is excellent in durability without deteriorating hemostasis.

[Brief description of the drawings]

FIGS. 1A to 1D are perspective views 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 diagram showing a use state of the medical insertion assisting device.

FIG. 4 is a schematic diagram showing a use state of the medical insertion assisting device.

FIG. 5 is a schematic diagram showing a use state of the medical insertion assisting device.

FIG. 6 is a sectional view of a medical valve element according to another embodiment of the present invention.

FIG. 7 is a sectional view of a medical valve body according to another embodiment of the present invention.

FIG. 8 is a cross-sectional view of a medical valve element according to still another embodiment of the present invention.

FIG. 9 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]

 4 Dilator 6 Introducer (medical insertion aid) 8 Dilator body 8a Tapered tip 10 Cap 14 Sheath 16 Sheath hub 40, 40A, 40B, 40C Medical valve 42, 42A, 42B , 42C ... first layer 44, 44A, 44B, 44C ... second layer 46 ... contact hole 48 ... through hole 50 ... slit

Claims (2)

[Claims] 1. A medical valve body having a contact hole through which a long insert can be inserted while maintaining liquid tightness, wherein the medical valve body has at least a first layer and a second layer. The first layer located on the insertion surface side of the long insert is made of a material having a large tear strength and a large elongation, and the second layer is made of a material having a large elasticity and a low permanent set. A medical valve body composed of: 2. A medical insertion aid having the medical valve element according to claim 1.