JPH08168532A - In-vivo inserting means for medical treatment - Google Patents

Abstract

PURPOSE: To obviate the imperfect closure of a through hole by deterioration of a hemostatic valve penetrated with an expanding tube or inside needle which is the inside tube of a catheter introducer or indwelling needle with time. CONSTITUTION: The inside tube 1 to be removed after introduction into the desired section through the hemostatic valve 14 inserted into a hub 8 at the base end of an outside tube 7 is inserted into this outside tube 7. The part of the inside tube 2 penetrating through the hemostatic valve 14 is formed as a small-diameter part 2 of an annular groove shape and since the through hole is small, the through hole is perfectly closed in spite of lowered elastic force when this part is removed.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical inserter which is percutaneously introduced into a blood vessel or a bile duct in the body, that is, a catheter introducer or an indwelling needle. The present invention relates to an inserter having a structure that includes a hemostatic valve that prevents the outflow of blood and the like when taken.

[0002]

2. Description of the Related Art A catheter introducer used for percutaneously introducing a catheter for diagnosing or treating blood vessels and organs into a blood vessel comprises a dilator and a sheath having a small diameter. Insert the expansion tube into the blood vessel by inserting the expansion tube into the body by inserting the expansion tube into the sheath by connecting the proximal hubs to each other with the distal end protruding into the sheath and inserting it into the blood vessel. After that, the guide wire and the expansion tube are removed, and the catheter is inserted into the sheath to reach the target site. An indwelling needle that is punctured and placed in a blood vessel or a bile duct for blood transfusion or infusion, or conversely, for blood removal or effusion consists of an inner needle and a cannula (catalyst), and a needle base and a hub at their proximal ends. To each other by inserting the inner needle with the tip protruding through the cannula, puncturing the target site with the inner needle, and then withdrawing the inner needle, and connecting the blood or drug solution container or aspirator or artificial kidney circuit to the cannula. To do.

That is, these have a two-layer structure of an expansion tube or an inner needle which is an inner tube and a sheath or a cannula which is an outer tube, and they pass through the outer tube when the inner tube is removed by reaching a target site. In order to prevent blood and the like from flowing out, a hemostatic valve is provided on the hub at the proximal end of the outer tube.

This hemostatic valve is made of synthetic rubber such as urethane rubber, silicone rubber, chloroprene rubber, etc., as well as a natural elastic material such as natural rubber or synthetic resin in the shape of a disc having a size covering the entire cross section of the hub. Normally, the inner tube is inserted into and removed from the outer tube through its center. Then, when the inner tube is pulled out, the through hole is immediately closed to be in a closed state, and in the case of the catheter introducer, a close contact state with the outer peripheral surface thereof so that blood does not leak when the catheter is introduced. Is required.

In order to cope with this requirement, a hole having a size that can be closed by the elasticity of the material itself is provided in the center, and the inner tube or catheter is penetrated at the same location in the center, and the entire outer peripheral surface is evenly adhered well. To be in a state (actual Kaihei 1-87
No. 746), and to provide a notch (slit) extending in the radial direction through the center in order to improve the blocking property and the adhesion (Japanese Patent Application Laid-Open No. 1-139077, Japanese Patent Publication No. 2-949). Kaihei 1-87746) is proposed.

[0006] However, the inner tube pushes the center of the hemostasis valve, which is originally in the closed state, by an amount corresponding to the outer diameter, and penetrates the hemostasis valve, and the hemostasis valve is brought into a compression deformation state in which the hemostasis valve is in close contact with the outer peripheral surface of the inner tube.

[0007]

[Problems to be Solved by the Invention] The catheter introducer and the indwelling needle are sterilized and packaged and shipped from the manufacturer.
The inner tube is placed through the hemostasis valve through the outer tube until the physician opens the package for use. The storage period from manufacture to use varies, and for example, it is often a long period of about one year.

As described above, when the storage period is long, the hemostatic valve that is expanded by the inner tube and remains in the compressed deformation state gradually decreases in elastic force due to unavoidable deterioration over time. When the inner tube is pulled out, it cannot be completely restored, and the through hole may not be completely closed. For this reason, when a blood vessel or the like is punctured and the inner tube is withdrawn, blood or the like flows out and the purpose as a hemostasis valve cannot be achieved.In addition, in the case of a catheter introducer, the adhesion with the catheter also decreases and blood leakage As a result, the function as a hemostasis valve is impaired.

Therefore, an object of the present invention is to provide a hemostatic valve for a long period of time even after the hemostatic valve is placed in a state of penetrating the inner tube.
To provide a catheter introducer or an indwelling needle in which a through hole is closed when an inner tube is pulled out and good adhesion with a catheter is obtained.

[0010]

SUMMARY OF THE INVENTION The present invention has a two-layer structure of an inner tube and an outer tube, and a hemostasis valve installed in a hub at the proximal end of the outer tube penetrates the inner tube so that the tip of the inner tube projects to the outer tube. In order to solve the above-mentioned problem that the medical instrument has a medical in-body inserter that is inserted through the inner tube and then the inner tube is removed after being introduced to the target site, that is, a catheter introducer or an indwelling needle A portion was formed and this small diameter portion was used as a penetration point into the hemostasis valve.

[0011]

Since the portion of the inner tube that penetrates the hemostasis valve has a small diameter, the degree of compressive deformation of the inner tube of the hemostasis valve is small and the through hole is also small. For this reason, when the inner tube is used after long-term storage and the elastic force of the hemostatic valve has deteriorated due to deterioration over time, the through hole is completely blocked, and when the catheter is penetrated, the small diameter part is penetrated. Since it can be expanded further than that, it adheres well and does not impair the function of the hemostasis valve.

[0012]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the present invention will be described with reference to the drawings. FIG. 1 is an example in which the present invention is applied to a catheter introducer, which is fixed to the proximal end of an expansion tube 1 made of a synthetic resin thin tube. The hub 3 and the hub 8 fixed to the base end of the sheath 7 also made of a synthetic resin thin tube are formed in the distal end side open tubular portion 4 of the expansion tube hub 3 into the two spiral grooves 5 of the sheath side hub 8. The two small protrusions 10 formed on the body 9 are engaged with each other to be separably coupled.

The hub 8 of the sheath 7 is provided with a disk-shaped hemostasis valve 14 sandwiching a peripheral edge portion of a hub body 9 and a pressing cap 11 fitted at the base end thereof. The base end side of the through-hole formed has a large diameter and the tip end side closes the base end surface of the insertion hole 12 having a small diameter.

The expansion tube 1 penetrates the center of the hemostasis valve 14 and traverses the insertion hole 12, and is fitted into a sheath 7 extending continuously in front of the expansion tube 14 almost densely and inserted with its tip slightly projected. There is. An annular groove-shaped small-diameter portion 2 having a maximum outer diameter of 50%, generally 80 to 95%, is formed at the proximal end of the expansion pipe 1, and the small-diameter portion is formed. 2 penetrates the hemostasis valve 14 and expands.

In this embodiment, the small-diameter portion 2 is arranged in the axial direction so that the penetrating portion is always the small-diameter portion 2 even if the position of the hemostatic valve 14 is slightly different depending on the structure of the hub 9 of the outer tube 7. The groove width has a length of. Moreover, by doing in this way, the small diameter part 2 can be made to penetrate even in the thing which piled up several hemostasis valves.

According to this embodiment having such a structure, the hemostatic valve 14 is expanded by the small diameter portion 2 of the expansion tube 1 into a compressed deformation state, so that it can be expanded by the original outer diameter portion of the expansion tube 1. The degree of compressive deformation is smaller and the through holes are also smaller. Further, when the expansion tube 1 is fitted to the guide wire for introduction into the body, there is no concern that the small diameter portion 2 secures a sufficient inner diameter and thus hinders the introduction of the guide wire.

When the guide wire and the expansion tube 1 are removed from the body by introducing the guide wire and the expansion tube 1, even if the elastic force of the hemostatic valve 14 is lowered due to deterioration over time, the through hole is small and completely closed. There is no peeling and the blood filling the sheath 7 does not flow out. Further, when the catheter is inserted into the sheath 7, the catheter has an outer diameter similar to that of the expansion tube, and thus the hemostasis valve 14 is expanded more than when the small diameter portion 2 is penetrated. That is, since the small diameter portion 2 is penetrated, the hemostatic valve 14 is pushed and expanded more largely than the expansion and deformation when stored for a long period of time, and is largely compressed and deformed, so that the hemostasis valve 14 adheres well to the entire outer peripheral surface of the catheter. This completely prevents the blood leaking through the gap between the sheath 7 and the catheter from leaking.

FIG. 2 is an example in which the present invention is applied to an indwelling needle. A needle base 23 fixed to the base end of an inner needle 21 made of a metal thin tube and a base end of a cannula 27 made of a synthetic resin thin tube. The fixed hub 28 and the hub flange 23 of the needle base 23
And a holding cap 31 fitted to the base end of the hub 28 are fitted together so as to be separable from each other.

The hub 28 includes a hub body 29, two bottomed tubular hemostatic valves 34 fitted in a valve chamber 30 thereof, and a cap 3 for holding.
The hemostatic valve 34 is fitted in the valve chamber 30 with the tubular portions facing each other and the bottom portions thereof spaced from each other, and is prevented from coming off by the pressing cap 31. Insertion hole 32 that penetrates from the tip to the tip surface
Is blocking.

The inner needle 21 penetrates through the centers of the two hemostasis valves 34, traverses the insertion hole 32, and is fitted into the cannula 27 extending in the front thereof in a substantially dense manner so that the puncture portion having a beveled tip is projected. It has been inserted. Further, at the base end portion of the inner needle 21, two annular groove-shaped small diameter portions 22 reduced in outer diameter to the same extent as in the embodiment of FIG. 1 are formed. It penetrates the bottom of the hemostasis valve 34 and pushes it out.

In this embodiment, the small diameter portion 22 is connected to the hemostasis valve 34.
Although the groove width is slightly larger than the wall thickness, it may be configured such that the two hemostatic valves 34 are penetrated as one small diameter portion having one long groove width as shown in FIG.

Also in this embodiment having such a structure, the hemostatic valve 34 is expanded by the small-diameter portion 22 of the inner needle 21 and is in a compressed deformation state, so that it is expanded by the original outer diameter portion of the inner needle 21. Since the degree of compressive deformation is small and the through hole is also small, the inner needle 21 can be introduced into a target site in the body.
When the hemostatic valve 34 is withdrawn, even though the hemostatic valve 34 has deteriorated in elastic force due to deterioration over time, the through hole is completely closed and the cannula 27
Do not let the blood that is full of blood flow out.

The small-diameter portions 2 and 2 exemplified in each of the above-mentioned embodiments.
2 is to confirm that the blood has been introduced into a target site such as a blood vessel by flowing out through the expansion tube 1 and the inner needle 21, and that it is necessary to prevent cutting during handling. Therefore, it is advisable to avoid excessive reduction, and in consideration of the object of the present invention to completely occlude the through hole of the hemostasis valve, the reduction is made to a maximum diameter of 50%, generally 80 to 95%. It is preferable to do.

[0024]

As described above, according to the present invention in which the small diameter portion is formed in the inner tube and the small diameter portion is penetrated through the hemostasis valve, the hemostatic valve deteriorates its elasticity with the lapse of time after being stored for a long time. However, when the inner tube is pulled out, the through hole is small, so it can be completely blocked and the outflow of blood etc. can be prevented, and the hemostasis valve with the catheter inserted is larger than when the small diameter part is penetrated. Since it is pushed and spread, it can be well adhered to the outer peripheral surface of the catheter to prevent leakage of blood and the like, and thus the original function of the hemostasis valve can be fully exerted.

[Brief description of drawings]

FIG. 1 is a longitudinal sectional view of an example in which the present invention is applied to a catheter introducer.

FIG. 2 is a longitudinal sectional view of an example in which the present invention is applied to an indwelling needle.

[Explanation of reference numerals] 1 expansion tube, 2 small diameter part, 7 sheath, 8 hub, 14
Hemostasis valve, 21 inner needle, 27 cannula, 28 hub, 34 hemostasis valve

Claims (1)

[Claims] 1. A two-layer structure of an inner tube and an outer tube, which penetrates a hemostasis valve installed in a hub at a proximal end of the outer tube to allow the inner tube to be inserted into the outer tube with its tip protruding to a target site. In the medical in-vivo insertion tool in which the inner tube is taken out after the introduction, a small-diameter portion having an annular groove is formed at the proximal end portion of the inner tube, and the small-diameter portion penetrates the hemostasis valve, Medical inserter.