JPH07255857A - Blood vessel inserting tool for medical care - Google Patents

Abstract

PURPOSE:To easily and penetratingly pass a catheter or the like through a blood stopping valve internally trimmed in a hub on the outer tube base end being the guide, and perfectly prevent leakage of blood. CONSTITUTION:A blood stopping valve 11 formed of an elastic material is formed as a hollow body, and is divided into two valve part pieces by a vertical split on a diameter, and these are internally trimmed in a condition where divided surfaces 16 are opposed to each other and are compressed in the radial direction of a hub. A tube member such as a catheter is penetratingly inserted through the divided surfaces 16 of a top wall 14 and a bottom wall 13, and since the divided surfaces 16 are brought into pressure contact with each other, and leakage of blood is prevented, and since the flexible tube member is also the thin hollow divided surfaces 16, it can be easily inserted.

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, that is, a catheter introducer, in which an inner tube is extracted from a hub at a proximal end of an outer tube. 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 the blood flow occurs.

[0002]

2. Description of the Related Art A catheter introducer used for percutaneously introducing a catheter for diagnosing or treating a blood vessel or an organ comprises an expansion tube (dilator) which is an inner tube and a sheath which is an outer tube. , The hubs at their proximal ends are connected to each other, the expansion tube is inserted into the sheath with the distal end protruding, and the expansion tube is inserted into the guide wire that has been inserted into the blood vessel in advance and inserted into the body. After inserting the sheath into the blood vessel, the guide wire and the dilation tube are removed, and the catheter is inserted into the sheath to reach the target site.

In such an insertion tool, when the expansion tube is removed from the sheath, a hemostatic valve is provided in the hub so that blood does not flow out through the expansion tube until the catheter is inserted. Is being carried out.

On the other hand, in such an insertion tool, the outer tube becomes unnecessary after a predetermined medical device such as a catheter is introduced by utilizing the outer tube inserted and left in the blood vessel. In particular, the hub fixed to the proximal end of the outer tube has a significantly larger diameter and is harder than that, which not only interferes with medical procedures, but also allows the catheter to be inserted stably so It may cause discomfort if it is fixed to the surface with adhesive tape.

Therefore, Japanese Patent Laid-Open No. 4-221575 discloses an idea of removing the hub, which is unnecessary after the introduction of the catheter or the like, and the sheath, which is the outer tube, together with the hemostatic valve.

That is, according to the proposal described in the above publication, the hub is provided with a tear portion formed of a V-shaped notch groove extending in the central axis direction, and the hemostasis valve is provided with a tear portion corresponding to the tear portion of the hub. Is fixed to the hub with an adhesive, and the hub and the hemostasis valve are separated along the tear portion by pulling the opposing parts with the center of the hub in the direction of separating them from each other. It is designed to be separated and removed from the body, or a tear portion is also provided on the outer tube so that the outer tube can be removed from the body and then separated and removed together.

However, the above-mentioned hemostatic valve is a solid cylinder having a sufficient wall thickness, which is divided into two parts with an adhesive and the joining surface is arranged in substantially the same phase as the tear portion of the rib. The tear portion of the hemostasis valve is formed, or a cut is made in a part in the diameter direction and the line is arranged in substantially the same phase as the tear portion of the rib to form the tear portion of the hemostasis valve.

Therefore, when the expansion tube which is the inner tube is pulled out, the expansion tube insertion trace is completely blocked by the elasticity of itself and the outflow of blood can be effectively prevented. Since it has a thick shape, it acts as a great resistance against flexible tube members such as catheters,
There are cases in which it is extremely difficult to insert the catheter, and it takes time to introduce the catheter, or an unfamiliar person cannot insert the catheter.

Looking at the hemostasis valve itself, most of them are disc-shaped or column-shaped as seen in, for example, JP-A-59-133877, and are cuts that facilitate insertion of an inner tube or catheter. The hub is composed of a main body and a cap, and is sandwiched and fixed between them. Therefore, the break is closed only by the elasticity of itself and prevents the outflow of blood, so that a considerable wall thickness is inevitably required, and it may be difficult to insert a flexible tube member such as a catheter. Further, since they are not predicted to tear at all, they cannot be applied to those capable of tearing the hub as described above.

[0010]

SUMMARY OF THE INVENTION The problem to be solved by the present invention is to have a dual structure of an inner tube and an outer tube, and the inner tube passes through a hemostasis valve installed in the hub at the proximal end of the outer tube. In a medical blood vessel insertion tool in which the distal end is projected and inserted into the outer tube, and the inner tube is withdrawn after the blood vessel is introduced, not only does it prevent blood leakage while the inner tube is inserted and after withdrawal, but it also functions like a catheter. In addition, a flexible tube member can be easily inserted, and in addition, there is no one having a hemostasis valve applicable even when the hub can be torn.

[0011]

The present invention solves the above-mentioned problems, and can prevent blood leakage completely, can easily insert a flexible tube member, and can also be applied to a tearable rib. An object of the present invention is to provide a medical blood vessel insertion tool having a hemostasis valve. Then, as a first means for achieving this purpose, the hemostatic valve is a hollow body made of an elastic material, which is composed of a peripheral wall, a bottom wall and a top wall, and is divided into two valve parts by longitudinal division in diameter. With the structure. Then, the two valve pieces were installed in the hub in a radially compressed state with their split surfaces facing each other. Further, as a second means, in addition to the first means, a thin rupture line formed by a groove extending in the central axis direction is provided on the hub to divide it into two hub pieces, and the two valve pieces are divided into hub pieces. One was fixed to each. When the tubular member that is inserted into the outer tube is a needle, it is preferable to make the hollow portion of the hemostatic valve longer than the puncture portion formed obliquely at the needle tip.

[0012]

When a tubular member such as an expansion tube, a catheter, or a needle is inserted into the hub from the proximal end surface, it is inserted into the outer tube through the dividing surface of the top wall, the hollow portion, and the dividing surface of the bottom wall of the hemostasis valve. The top wall and the bottom wall can be easily inserted with a small resistance even by using a flexible pipe member by penetrating the dividing surfaces. Further, since the divided surfaces of the valve pieces facing each other in the compressed state are in pressure contact with the outer peripheral surface of the pipe member, the leakage of blood can be completely prevented even when the wall thickness is thin. If the hub has a break line and one valve piece is attached to each hub piece, when the hub is torn, the hemostasis valve is separated at the split surface at the same time, and the phase of the break line and the split surface is irrelevant. You can divide even if there is. When the hollow part of the hemostasis valve is made longer than the puncture part of the needle, blood leakage is prevented when the needle is removed.

[0013]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to the drawings, an embodiment of the present invention will be described. In FIGS. 1, 2, 3, 4 and 5, 1 is an inner tube exemplified by an expansion tube of a catheter introducer, and 2 is a sheath. The outer tube 5 is a hub fixed to the base end of the outer tube 2, and 11 is a hemostasis valve installed in the hub 5.

The hub 5 is made of a hard synthetic resin and has a base end side of a cylindrical shape and a tip end side of a conical shape, and the enlarged base portion 2a of the outer tube 2 is press-fitted into the enlarged hole portion 6 formed at the tip portion of a small diameter. ,
It is fixed by using an adhesive if necessary. Further, on the outer peripheral surface of the hub 5, two V-shaped grooves 7 extending in the central axis direction are provided over the entire length and at the center-to-line position, and the bottom of the groove 7 forms a thin break line 8. ing.

That is, the hub 5 has a shape composed of two hub portion pieces 5a and 5b divided by two breaking lines 8, and each hub portion piece 5a and 5b is formed at the base end so as to project toward the tip end. It has an extending knob piece 9 at the center-pair line position.

The hemostasis valve 11 is a hollow body made of a flexible and highly elastic natural rubber, synthetic rubber or synthetic resin, which is composed of a cylindrical peripheral wall 12 and a bottom wall 13 and a top wall 14 at both ends thereof. At the center of the wall 14, a through hole 15 having the same diameter as the outer diameter of the inner tube 1 or a diameter smaller than this is provided. In addition, the hemostatic valve 11 is vertically divided into two valve pieces 11
It is divided into a and 11b.

The two valve pieces 11a and 11b are fitted in the valve chamber 10 of the hub 5 with the bottom wall 13 positioned from the base end side to the tip end side in a state where the split surfaces 16 face each other and overlap each other. ing. The valve chamber 10 is made smaller in diameter than the hemostasis valve 11, and therefore the valve pieces 11a and 11b are compressed in the radial direction and the dividing surfaces 16 are strongly closed to each other.
Will be decorated in.

In this embodiment having such a structure, when the inner tube 1 is inserted into the hub 5 from the base end surface, the through hole 15 formed in the dividing surface 16 of the top wall 14 of the hemostatic valve 11 is expanded and hollow. It is to be inserted into the outer tube 2 after entering the portion 17, then pushing and expanding the dividing surface 16 of the bottom wall 13 and then passing through the outer tube 2.
The through hole 15 of 4 and the dividing surface 16 of the bottom wall 13 are in close contact with the outer peripheral surface of the inner tube 1 to completely prevent the leakage of blood (FIG. 5).
reference). This state is the same regardless of whether the inner tube 1 is an expansion tube or an inner needle or catheter.

When the inner tube 1 is pulled out, its tip passes through the bottom wall 13, and at the same time, the dividing surface 16 is strongly closed by the elastic force and the compressive force, and the blood entering the outer tube 2 is blocked. There is no leakage.

When the inner tube 1 is a needle, it is preferable to use, as the hemostatic valve 11, a hollow portion 17 having a length longer than that of the puncture portion 52 formed obliquely at the tip of the needle 51 as shown in FIG. preferable.

That is, in this way, when the needle 51 is pulled out, the tip of the puncture portion 52 is pulled out from the bottom wall 13, and there is a state in which the entire puncture portion 51 is located inside the hollow portion 17. At this time, the dividing surfaces 16 of the bottom wall 13 are closed to prevent the blood in the outer tube 2 from leaking into the hollow portion 17.
Therefore, when the puncture portion 52 passes through the through hole 15, a blood leak is prevented even though a gap is formed between them.

The above is the description of the invention described in claims 1 and 3, but in the present embodiment, the broken line 8 which is a constituent element of the invention described in claim 2 is also illustrated. The division of 5 and the hemostatic valve 11 will be described.

In this embodiment, the hub 5 is divided into two hub pieces 5a and 5b by two breaking lines 8 extending along the entire length in the central axis direction.
The two valve portion pieces 11a and 11b of the hemostasis valve 11 are fixed to the hub portion pieces 5a and 5b at the peripheral wall 12 one by one with the adhesive 18.

When the catheter or injection needle is introduced by penetrating the hemostatic valve 11 into the outer tube 2 that has been removed from the inner tube 1 and inserted into the blood vessel and left undisturbed, pulling it in the opposite direction with the knob 9 breaks it. The hub 5 is torn along the line 8 and divided into two hub pieces 5a and 5b, which are separated and removed from the outer tube 2 press-fitted into the tip portion. Since one valve piece 11a, 11b is fixed to each of the hub pieces 5a, 5b, the valve piece 11a, 11b is separated and removed together with these by the dividing surface 16 (see FIG. 7).

Since the hemostatic valve 11 is composed of two valve pieces 11a and 11b which are installed in the valve chamber 10 of the hub 5 in a compressed state without facing each other with the dividing surfaces 16 facing each other, the rupture line 8 and the dividing line 8 are divided. There is an advantage that the hemostasis valve 11 can be inserted into the hub 5 at an arbitrary phase at the time of assembling and the assembling work can be facilitated because the hemostasis valve 11 can be divided regardless of the phase with the surface 16.

The top wall 14 of the hemostasis valve 11 may have the same shape as the bottom wall 13 having no through hole 15. In addition, when the outer tube 2 is fixed to the hub 5 by adhesion, it is difficult to separate and remove the outer tube 2 when the hub 5 is torn.
Since it will not be necessary after introducing a catheter etc.,
As described in Japanese Patent Laid-Open No. 4-221575 mentioned above as a conventional technique, a breaking point corresponding to the breaking line 8 is provided in the outer tube 2 and only the tube member such as the catheter is torn while being pulled out from the body. May be left.

[0027]

As is clear from the above description, a book in which the hemostasis valve is a hollow body and valve pieces formed by dividing the hemostasis valve into two are opposed to each other at a dividing surface and are installed in the hub at the proximal end of the outer pipe in a radially compressed state. According to the invention, a valve member in a compressed state is pressed against the pipe member at two points of the top wall and the bottom wall by penetrating the dividing surface of the pipe member such as a catheter that is inserted into the outer pipe, and even if it is thin, leakage occurs. Not only can blood be completely prevented, but a flexible tube member such as a catheter can be easily inserted with a small resistance. In addition, when a catheter is introduced, it is possible to reduce the feeling by making the hemostasis valve hollow when performing operations such as knowing that it has protected the blood vessel wall due to a subtle change in the feeling transmitted to the fingertip and changing the direction a little. There is an advantage that it can be guided to a target site without worrying about damaging the blood vessel wall. Further, in the case where the hub is torn, the hemostatic valve is separated as it is at the dividing surface and is removed together with the hub, and the work of removing it so as not to interfere with medical treatment can be extremely facilitated.

[Brief description of drawings]

FIG. 1 is a vertical sectional view of an embodiment of the present invention.

FIG. 2 is a partially cutaway plan view of the embodiment of FIG.

FIG. 3 is a side view of the embodiment of FIG.

FIG. 4 is an exploded perspective view of the hemostasis valve in the embodiment of FIG.

5 is a vertical cross-sectional view of the embodiment of FIG. 1 with an inner tube inserted therethrough.

FIG. 6 is a vertical cross-sectional view of an embodiment for explaining the relationship between the hemostatic valve and the needle.

FIG. 7 is a partially cut-away side view for explaining a state where the hub of the embodiment of FIG. 1 is torn and separated.

[Explanation of symbols]

1 inner tube, 2 outer tube, 5 hub, 5a, 5b hub piece, 7 groove, 8 break line, 11 hemostasis valve, 11a,
11b valve piece, 12 peripheral wall, 13 bottom wall, 14
Top wall, 16 split surfaces, 17 hollow parts,

Claims (3)

[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 distal end protruding to introduce a blood vessel. In a medical blood vessel insertion tool from which an inner tube is to be removed later; the hemostatic valve is a hollow body made of an elastic material and having a peripheral wall, a bottom wall and a top wall, and is divided into two valve parts by longitudinal division in diameter. The medical blood vessel insertion tool is divided; and the two valve pieces are internally installed in the hub in a radially compressed state with dividing surfaces facing each other. 2. In addition to the structure according to claim 1, two hub pieces each having a thin break line formed by a groove extending in the direction of the central axis provided on the hub and defined by the break line. A medical blood vessel insertion tool, wherein each of the two valve pieces is fixed to the other one. 3. The tube member to be inserted into the outer tube is a needle, and the hollow portion of the hemostatic valve is made longer than the puncture portion formed obliquely at the tip of the needle. The medical blood vessel insertion tool described.