JPH04193182A - Catheter guiding device - Google Patents

Abstract

PURPOSE:To guide a catheter with no deformation or breakage by providing a hemostatic valve and a pressing means pinching both end faces of it on a hemostatic system inserted into a catheter guide hole, and pinching the hemostatic valve at a gap on the periphery of the through hole on the end face. CONSTITUTION:The hemostatic system 5 of a catheter guide body 3 has a hard pinching tube 5b inserted into the valve fitting section 3b'' of a catheter through hole 3b, a flexible disk-shaped hemostatic valve 5a inserted into a valve fitting section 3a'', a hard pinching tube 5c inserted into the valve fitting section 3b'' and protruded with an end section from the catheter through hole 3b while pinching the hemostatic valve 5a together with the pinching tube 5b, and a valve pressure adjusting member 5d fitted to the end face 3c of the catheter guide body 3. When the valve pressure adjusting member 5d is screwed, the pinching tube 5c presses the hemostatic valve 5a toward the pinching tube 5b, and the hemostatic valve 5a is deformed to block a through hole 5a'. Tapers 5e', 5f' are formed on the hemostatic valve 5a, and the through hole 5a' is closed without being distorted.

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a catheter introduction device for introducing a catheter into a blood vessel, and particularly to a hemostatic structure for preventing blood leakage.

[Conventional technology]

The lesions of ischemic heart disease caused by arteriosclerosis in the coronary arteries, or brain diseases caused by cerebral hemorrhage or cerebral thrombosis are located in areas that are difficult to directly visually observe. Therefore, catheters, which are thinner endoscopes used for definitive diagnosis and treatment of gastrointestinal, respiratory, and urinary organs, are introduced into coronary arteries, cerebral blood vessels, etc., and are used for direct visual observation and even blood vessel observation. Techniques have been developed for use in dilating the narrow part of a blood vessel, and a catheter introduction device is used to introduce such a catheter into a blood vessel.

Here, the structure of a conventional catheter introduction device is shown in Figure 4 (a).
) will be explained below.

In the same figure, reference numeral 11 denotes a catheter introduction device, and in the catheter introduction device 11, a hollow tubular sheath 2 to be introduced into a blood vessel is attached to one end 13a via a connecting member 2a. The catheter introducing body 13 having a catheter introducing hole 13b that communicates with the inside, and the valve fitting in which the inner diameter of the catheter introducing hole 13b is enlarged with a step 13b' are arranged in the part 13b#, and blood is drawn from the catheter introducing hole 13b. The hemostatic mechanism 15 prevents leakage.

The hemostasis mechanism 15 of such a catheter introduction device 11 is
The valve fitting of the catheter passage hole 13b is fitted into the portion 13b', and includes a cylindrical flexible hemostasis valve 15a whose one end surface is fixed to the stepped portion 13b', and a hemostatic valve 15a adjacent to the hemostatic valve 15a. In this state, the valve installation includes a push tube 15b fitted into the section 13b' and a protrusion 15c" attached to the end 13c of the catheter introducer 13 via a screw mechanism to press the push tube 15b. The catheter 4 is connected to each of the hemostasis valve 15a, the pressure tube 15b, and the valve pressure adjustment member 15c.
Four through holes 15a', 15b', and 15c' are formed so as to be able to communicate with each other.

In the catheter introduction device 11 having such a configuration, when the valve pressure adjustment member 15c is pushed in, the push tube 15b is pushed toward the step 13b', the hemostasis valve 15a is deformed, and the through hole 15a' is Close, in this state, sheath 2
After introducing the catheter into the blood vessel and sending its tip to the observation site, the catheter 4 is pushed into the through hole 15a',
The catheter is introduced into the sheath 2 through the catheter passage hole 13b.

Here, a hemostasis valve 15a is provided on the outer periphery of the catheter 4.
As shown in Figure (b), they are in close contact to prevent blood leakage.

(Problems to be Solved by the Invention) However, in the conventional catheter introduction device 11, the hemostasis mechanism 15 has the following problems.

(2) The hemostasis valve 15a is a cylinder with a constant thickness, and the deformation caused by being pressed is dispersed, which tends to cause uneven deformation.

Therefore, the catheter 4 introduced into the through hole 15a'
As shown in Fig. 4 (,c), there is a gap 15a'' around the
may occur and the bleeding may not be completely stopped. Therefore, if the hemostasis valve 15a is further pressed, the ultra-thin catheter or catheter for dilation will bend, causing trouble in observation or dilation.

■ When introducing the catheter 4 into the sheath 2 with the hemostasis valve 15a in close contact with the periphery of the catheter 4,
Since the contact area between the catheter 4 and the hemostasis valve 15a is large, friction is large and smooth introduction is not possible. moreover,
If excessive force is applied, the catheter 4 will bend and break.

■ When introducing the catheter 4 into the through hole 15a' of the hemostasis valve 15a in the closed state, insert the tip of the catheter 4 into the through hole 1.
5a'.

■ Hemostasis conditions are set when the valve pressure adjustment member 15c is pushed in, but the settings depend on the user's senses;
Excessive tightening may cause deformation and damage to the catheter 4.

In view of the above problems, an object of the present invention is to adopt a hemostasis structure that applies uniform pressure around the catheter, and to provide a display means to indicate appropriate pressing conditions, thereby preventing deformation and breakage of the catheter. It is an object of the present invention to provide a catheter introduction device that can introduce a catheter into a blood vessel without fail and without fail.

[Means to solve the problem]

In order to solve the above-mentioned problems, a catheter introducing body has a hollow tubular sheath to be introduced into a blood vessel connected to one end thereof and a catheter passage hole communicating with the inside of the sheath;
In a catheter introduction device equipped with a hemostasis mechanism for preventing blood leakage from a catheter passage hole, the hemostasis mechanism is fitted into the catheter passage hole,
The hemostasis valve has a flexible hemostasis valve having a through hole through which the catheter is passed, and a pressing means capable of sandwiching both end faces of the hemostasis valve and pressing the end faces. It is characterized by being sandwiched around the through hole in the end face with a gap.

At least one end face of such a hemostasis valve is formed with a taper or step that requires the wall thickness on the through-hole side to be thinner than the surrounding area, and it is desirable that this creates the above-mentioned gap. .

In addition, the pressing means is in contact with one end surface of the hemostasis valve inserted into the catheter passage hole, and is connected to the stepped part of the catheter passage hole for positioning the hemostasis valve and the other end of the catheter introduction body through a screw mechanism. It is desirable that the valve pressure adjusting member be attached to the valve pressure adjusting member and that can be screwed in to push the other end surface of the hemostasis valve toward the stepped portion.

Furthermore, it is preferable that the pressing means further includes a clamping tube disposed adjacent to at least one end surface of the hemostasis valve, and clamps the hemostasis valve via this clamping tube.

Furthermore, display means for displaying the pressed state and open state of the valve pressure adjustment member to the hemostasis valve, such as a mark marked on the outer circumferential wall of the catheter introducer and the valve pressure adjustment member to display the relative positional relationship thereof, is provided. It is desirable to be present.

[Effect]

When the flexible hemostasis valve fitted into the catheter passage hole is pressed by the pressing means, the hemostasis valve deforms into a shape that closes the through-hole, thereby preventing blood from leaking around the catheter. Here, since the hemostasis valve is held with a gap around the through hole on one end face, a high pressing force is applied to the outer periphery of the hemostasis valve, and a low pressing force is applied to the periphery of the through hole. Therefore, the deformation of the hemostasis valve is concentrated around the through hole without being biased, and the through hole is uniformly reduced to a closed state.Therefore, the outer periphery of the catheter introduced into the through hole is Since the hemostasis valve fits tightly with even pressure, the area around the catheter is completely occluded, ensuring hemostasis is achieved and the catheter is prevented from deforming.Furthermore, even if the diameter of the catheter to be introduced changes, the diameter of the catheter remains unchanged. You can also make fine adjustments depending on the situation.

Here, at least one end face of the hemostasis valve is formed with a taper or step that should make the artist on the through-hole side thinner than the surrounding area, and if this creates the above-mentioned gap, The contact area between the catheter and the hemostasis valve is reduced, and the frictional force is reduced. Therefore, the bleeding remains in a state of hemostasis,
The degree of catheter introduction can be adjusted without applying excessive force.

In addition, when the above-mentioned pressing means is composed of a step portion formed inside the catheter passage hole and a valve pressure adjusting member attached to the other end of the catheter introducer via a screw mechanism, the step portion The hemostatic valve can be reliably held by the valve pressure adjusting member, and the end face of the hemostasis valve can be easily pressed and deformed by screwing the valve pressure adjusting member.

Furthermore, when the pressing means includes a hard clamping tube adjacent to at least one end surface of the hemostasis valve, the hemostasis valve can be pressed through the clamping tube, so that the hemostasis valve can be made thinner. Therefore, deformation of the hemostasis valve can be uniformly concentrated on the through hole side.

As a display means for indicating the pressed/released state of the valve pressure adjustment member, for example, when a mark is provided on the outer circumferential wall of the catheter introducer and the valve pressure adjustment member to display the relative positional relationship thereof, Since excessive deformation of the hemostasis valve due to over-tightening can be prevented, the above-mentioned hemostasis operation can be performed more reliably. Furthermore, deformation of the catheter can be reliably prevented. Moreover, a display function can be added at low cost.

〔Example〕

1. Next, a catheter introduction device according to a first embodiment of the present invention will be described below with reference to FIG. 1(a).

This figure is a sectional view showing the structure of the catheter introduction device of this example.

In the figure, reference numeral 1 denotes a catheter introduction device, in which a hollow tubular sheath 2 to be introduced into a blood vessel is attached to one end 3a, and a catheter introduction device communicates with the inside of the sheath 2. It is composed of a catheter introducer 3 having a hole 3b, and a hemostasis mechanism 5 disposed on the other end 3C side of the catheter introducer 3 to prevent blood from leaking from the catheter introduction hole 3b. . Here, the catheter introducer 3 has a sheath 2
The distal end 2a' of the connecting member 2a is screwed to form an internal threaded part 3d', and the sheath mounting is connected to the member 3d via the backing 3e. The catheter introduction member 3f includes a physiological saline injection hole 3f' that branches at the middle of the catheter introduction hole 3b. The catheter passage hole 3b that passes through the sheath attachment member 3d and the catheter introduction member 3f is formed with a valve attachment portion 3b'' whose inner diameter is enlarged with a stepped portion 3b'. The mechanism 5 includes a hard clamping tube 5b that is fitted into the section 3b'' and fixed to the stepped section 3b' for the valve installation of the catheter passage hole 3b, and a flexible tube that is fitted into the section 3a# for the valve installation. The valve is attached to the portion 3 with a flexible disk-shaped hemostasis valve 5a and the hemostasis valve 5a being held between the clamping tube 5b.
a hard clamping tube 5C that is fitted into the catheter guide hole 3b and whose end protrudes from the catheter passage hole 3b; and a valve pressure adjustment member 5d that is attached to the end 3C of the catheter introducer 3 by forming a screw mechanism. The hemostasis valve 5a, the clamping tubes 5b, 5c, and the valve pressure adjustment member 5d all have through holes 5a', 5b through which the catheter 4 is to be passed.
', 5c' and 5d' are formed so as to be able to communicate with each other.

Here, FIG. 1(b) is a sectional view showing the shape of the hemostasis valve 5a, and there are through holes 5 in both end surfaces 5e and 5f of the hemostasis valve 5a.
Tabers 5e' and 5f' are formed toward a',
The wall thickness on the side of the through hole 5a' is thinner than the surrounding area. By these tabers 5et, 5(r, the hemostasis valve 5a
Both end surfaces 5e and 5f of the holding tubes 5b and 5C are structured so as to be in contact with the periphery of the through hole 58' with a gap between them.

Further, on the outer peripheral wall of the end 3c of the catheter introducer 3, as shown in FIG. 1(c), three markings 3i, 3i',
3i'' is stamped, and on the other hand, one stamp 5d" is stamped on the outer peripheral wall of the valve pressure adjustment member 5d.
The pressed state and open state of the valve pressure adjusting member 5d are indicated by the positional relationship of t, 3 i', and 3 i'-. For example, by setting the stamp 5d'' between the stamps 3i and 3i', the hemostasis valve 5a is deformed with an appropriate pressing force,
Through-hole 5a through which catheter 4 can be passed without deforming
It is now possible to set the closed state of '.

In the catheter introducing device l having such a configuration, when the valve pressure adjusting member 5d is screwed in until its marking 5d'' is positioned between the markings 3i and 3i' of the catheter introducing body 3, the clamping tube 5c will close the hemostasis valve 5a. When pressed toward the clamping tube 5b, the hemostasis valve 5a deforms into a state that closes its through hole 5a'.Here, the hemostatic valve 5a is formed with tapers 5e' and 5f', and the hemostasis valve 5a is formed with tapers 5e' and 5f' to close the through hole 5a'. Since the side wall thickness is thinner than the surrounding area, a lower pressing force is applied to the periphery of the through hole 5a' compared to the outer peripheral edge side.Therefore, the deformation of the hemostasis valve 5a is not biased, and the through hole 5a' The sheath 2 is concentrated on the side of the hole 5a+, and the through hole 5a' is closed without distortion.In this state, the sheath 2 is introduced into the blood vessel and its tip is sent to the observation site, and then the catheter 4 is inserted. Catheter passage hole 3
b.

At this time, the catheter 4 introduced through the through hole 5d' of the valve pressure adjusting member 5d is easily guided into the through hole 5a' by the taper 5f' of the hemostasis valve 5a. Furthermore, the catheter 4 is sent through the catheter passage hole 3b and introduced into the inside of the sheath 2.

At this time, since the contact area between the catheter 4 and the hemostasis valve 5a is small, the frictional force is small, so the catheter 4 can easily
can be introduced. In this state, on the outer periphery of the catheter 4,
As shown in FIGS. 1(d) and (e), the hemostasis valve 5a is in close contact and the hemostatic state is maintained. Here, through hole 5
Since a' is uniformly contracted and closed, the hemostasis valve 5a is in close contact with the catheter 4 with equal pressure, so that the hemostatic state can be maintained reliably and the catheter 4 will not be deformed. .

Furthermore, since the markings 3i, 3i', 3i' and 5d'' indicate the screwed-in/opened state of the valve pressure adjustment member 5d, distortion of the hemostasis valve 5a due to excessive screwing will not occur.Therefore, the catheter Even if 4 is introduced,
Catheter 4 does not deform.

In addition, as a hemostasis valve having a shape other than that of the first embodiment, as shown in FIGS. 2(a) and 2(b), a hemostasis valve 25a having a taper 25f' formed only on one end surface, or a small step may be used. The same effect can be obtained even if a hemostasis valve 35a is used in which the through-hole 35a' side is formed in a continuous manner so that the wall thickness on the side of the through hole 35a' is thinner than the surrounding area. Also, the valve installation is part 3a#
In FIG. 2 (
As shown in C), flexible spacers 7 may be arranged.

]'' Dr. J. Next, a catheter introduction device according to a second embodiment of the present invention will be described below with reference to FIG. 3(a).

This figure is a sectional view showing the structure of the catheter introduction device of this example.

In the figure, reference numeral 41 denotes a catheter introduction device, and its hemostatic mechanism 41' includes a hard clamping tube 43 that is fitted into the valve fitting portion 42a' of the catheter passage hole 42a and fixed to the stepped portion 42a''. The valve is installed with the flexible disc-shaped hemostasis valve 44 fitted into the portion 42a' and the protrusion 45a inserted into the catheter passage hole 42a.
and a valve pressure adjusting member 45 whose tip is in contact with the end surface of the hemostasis valve 44. Here, this protrusion 4
Valve pressure adjustment member 45 at the clamping surface 45a' at the tip of 5a
A taper 45a' is formed around the through hole 45', and the end surface of the hemostasis valve 44 and the clamping surface 4 of the valve pressure adjustment member 45 are connected to each other.
5a' is in contact with the periphery of the through hole 44a of the hemostasis valve 44 with a gap therebetween.

The other configuration of the catheter introduction device 41 is similar to that of the first embodiment.

In the hemostasis mechanism 41' having such a configuration, by screwing the valve pressure adjusting member 45, the protrusion 45 can be adjusted.
a presses the hemostasis valve 44 toward the clamping tube 43; This pressing force deforms the hemostasis valve 44 and closes its through hole 44a. Here, since a taper 45a' is formed on the clamping surface 45a', a high pressing force is applied to the outer peripheral edge side of the hemostasis valve 44, and a through-hole of the hemostatic valve 44 corresponding to the taper 45a# of the clamping surface 45a' A low pressing force is applied to the periphery of 44a. Therefore, the deformation of the hemostasis valve 44 is caused by the taper 45a.
# through hole 44. Concentrate on side a. Therefore, the hemostasis valve 44 deforms without being biased, and the through hole 44
Since the periphery of the catheter 46 introduced into the tube a is evenly closed, deformation of the catheter 46 does not occur.

A catheter introduction device having a configuration other than the catheter introduction device 41 according to the second embodiment described above is shown in FIG.
), the hemostasis valve 51 has a catheter passage hole 520.
It is held between the stepped portion 52a and the clamping tube 53 so that it can be pressed, and the clamping surface 52a' of the stepped portion 52a
A gap may be formed around the through hole 51a of the hemostasis valve 51 by the taper 52a# formed in the hemostasis valve 51.Also, as shown in FIG. One of the clamping tubes 62 and 63 is
The clamping surface 62a may have a taper 62a'.

The catheter introducer may be formed integrally or may be formed by connecting a plurality of members, and there are no restrictions on the configuration of the catheter introduced.

〔Effect of the invention〕

As described above, the catheter introduction device according to the present invention has a hemostasis mechanism consisting of a hemostasis valve and a pressing means that can be pressed while holding the hemostasis valve, and the hemostatic valve has at least one end surface of the hemostatic mechanism that is Since it is characterized by being sandwiched with a gap around the hole, the following effects are achieved.

(2) Since a lower pressing force is applied to the side around the through-hole of the hemostatic valve than to the outer peripheral edge thereof, deformation of the hemostasis valve is concentrated on the side of the through-hole. Therefore, the hemostasis valve closes the outer periphery of the catheter with equal pressure, so that blood leakage can be completely prevented without causing deformation of the catheter.

(2) If a taper or step for forming the above-mentioned gap is formed on at least one end face of the hemostasis valve, the contact area between the catheter and the hemostasis valve can be reduced, and the Wll direction force can be reduced. Therefore, the degree of catheter introduction can be adjusted without applying excessive force while maintaining hemostasis.

■ When the above-mentioned pressing means consists of a step portion formed inside the catheter passage hole and a valve pressure adjustment member attached to the other end of the catheter introducer via a screw mechanism, the step portion and The hemostatic valve can be reliably held by the valve pressure adjusting member, and the end face of the hemostasis valve can be easily pressed and deformed by screwing the valve pressure adjusting member.

■ If the pressing means further includes a clamping tube adjacent to at least one end surface of the hemostasis valve, the hemostatic valve can be clamped via the clamping tube, making the hemostasis valve thinner (and concentrating the deformation of the hemostasis valve on the through-hole side). can.

(2) If a display means is provided to indicate the pressed/released state of the valve pressure adjusting member, excessive deformation of the hemostasis valve due to over-tightening can be prevented, and the above-mentioned hemostasis operation can be performed more reliably. Furthermore, deformation of the catheter can be reliably prevented.

■ If the above-mentioned display means is, for example, marked on the outer circumferential wall of the catheter introducer and the valve pressure adjustment member and consists of a mark indicating their relative positional relationship, an over-tightening prevention display can be added at low cost. be able to.

[Brief explanation of the drawing]

FIG. 1(a) is a sectional view showing the structure of a catheter introduction device according to a first embodiment of the present invention, and FIG. 1(b) is a sectional view showing the structure of a hemostasis valve thereof. (C) is a perspective view of the area around the valve pressure adjusting member showing the configuration of the display means, FIG. 1(d) is a sectional view of the area around the hemostasis mechanism showing the hemostatic state, and FIG. FIG. 1 is a sectional view taken along line AA' in FIG. 1(d). FIGS. 2(a) and 2(b) are sectional views showing the structure of another hemostasis valve, and FIG. 2(C) is a sectional view showing the structure of another embodiment of the valve. Fig. 3(a) is a sectional view showing the structure of the hemostasis mechanism of the catheter introduction device according to the second embodiment of the present invention, and Figs. 3(b) and 3(c) are the hemostasis mechanisms of other configurations. FIG. FIG. 4(a) is a sectional view showing the structure of a conventional example, and
FIG. 4(b) is a cross-sectional view of the area around the hemostasis mechanism showing a hemostasis state, and FIG. 4(C) is a cross-sectional view taken along line AA' in FIG. 4(b). [Explanation of symbols] 1.11... Catheter introduction device 3.13... Catheter introduction body 3b, 13b, 42a, 52... Catheter introduction hole 3
i, 3i', 3i', 5d'...marked 4.46...
Catheter 5.15.41'... Hemostasis mechanism 5a, 25a, 35a, 44, 51.61... Hemostasis valve 5b, 5c, 43, 53, 62.63 - Clamping tube 5d, 1
5c, 45...Valve pressure adjustment member. Fig. 1 (b) Fig. 1 (d) Fig. 2 (a) Fig. 2 (b) Fig. 2 (c) Fig. 3 (Q), /41-Agata Fig. 3 (b) 1a 3 Figure (C) 62a bl Lnu+ - Figure 4 (b)

Claims (6)

[Claims] (1) A catheter introducer having a hollow tubular sheath for introducing a catheter into a blood vessel connected to one end thereof, and a catheter introducing hole communicating with the inside of the sheath, and a catheter introducing body having a catheter introducing hole communicating with the inside of the sheath, and a catheter introducing body having a catheter introducing hole communicating with the inside of the sheath, and a catheter introducing body having a hollow tubular sheath for introducing a catheter into a blood vessel. A catheter introduction device comprising: a hemostasis mechanism for preventing leakage; the hemostasis mechanism includes a flexible hemostasis valve that is fitted into the catheter passage hole and has a through hole through which the catheter passes; and the hemostasis valve. and a pressing means capable of holding and pressing both end surfaces of the hemostasis valve, and the hemostasis valve is held with a gap around the through hole on at least one end surface of the hemostatic valve. catheter introduction device. (2) In claim 1, at least one end surface of the hemostasis valve is formed with either a taper or a step that makes the wall thickness on the through-hole side of the hemostasis valve thinner than the surrounding area. A catheter introduction device characterized in that the gap is formed by the above-mentioned gap. (3) In claim 1 or 2, the pressing means is in contact with one end surface of the hemostatic valve inserted into the catheter 1 passage hole to position the hemostatic valve. a valve pressure adjusting member that is attached to the stepped portion of the hole and the other end of the catheter introducer via a screw mechanism, and is capable of pushing the other end surface of the hemostasis valve toward the stepped portion by screwing the member; , wherein the hemostasis valve is held between the stepped portion and the valve pressure adjusting member. (4) In claim 3, the pressing means further includes a clamping tube disposed adjacent to at least one end surface of the hemostasis valve, and the hemostasis valve is clamped via the clamping tube. A catheter introduction device characterized by: (5) In any one of Claims 3 and 4, the pressure adjustment member further controls the pressing state of the valve pressure adjusting member against the hemostasis valve.
A catheter introduction device comprising display means for indicating an open state. (6) The catheter introduction device according to claim 5, wherein the display means comprises a mark marked on the outer circumferential wall of the catheter introduction body and the valve pressure adjustment member to indicate their relative positional relationship. Device.