JP3691091B2 - Introducer - Google Patents

Description

[0001]
[Industrial application fields]
The present invention relates to an introducer used to introduce a catheter into a blood vessel or the like.
[0002]
[Prior art]
Conventionally, a medical instrument generally referred to as a catheter introducer has been used as an instrument used to introduce a catheter into a blood vessel. A catheter introducer is usually composed of a sheath part having a sheath and a sheath hub, and a dilator part having a dilator and a dilator hub, and is first inserted into the blood vessel by an indwelling needle for percutaneous insertion into the blood vessel. After inserting the mini guide wire inserted into the tube and removing the indwelling needle, the introducer is inserted into the blood vessel through the mini guide wire, the dilator hub is removed from the sheath hub together with the mini guide wire, and then the guide wire is inserted and the guide wire is inserted. After the catheter is inserted along the wire and the guide wire is removed, the intended treatment is performed.
[0003]
Several examples of the fitting method of the dilator hub and the sheath hub in the introducer used in this way have been disclosed.
[0004]
For example, (1) Japanese Patent Application Laid-Open No. 2-289269 discloses a method for forming a female fitting portion of a tapered sheath hub and forming a polygonal cross section in the same manner as a male fitting portion of a tapered dilator hub. In addition, a taper fitting that can prevent movement in the rotational direction by making the axial movement polygonal is disclosed.
[0005]
(2) In the actual utility model 1-112849, a spiral convex part is formed at the end of the sheath hub, and a groove part engaging with the spiral convex part of the sheath hub is formed at the end of the dilator hub. What is screwed is disclosed.
[0006]
Also, (3) Japanese Patent Publication No. 3-37430 has a female prism at the end of the sheath hub and a male prism at the end of the dilator hub to prevent rotational movement and the female prism. The thing which forms a convex part and a recessed part in the fitting surface of a male type | mold prismatic part, and can prevent the motion of an axial direction is disclosed.
[0007]
(4) In Japanese Utility Model Laid-Open No. 5-56153, a flange that fits to the end of the sheath hub is formed at the end of the dilator hub, and a groove is formed on either the inner peripheral surface of the flange or the outer peripheral surface of the sheath hub. There has been disclosed one that can prevent axial movement by forming a convex portion that engages with the groove on either the inner peripheral surface of the flange or the outer peripheral surface of the sheath hub.
[0008]
(5) In Japanese Utility Model Laid-Open No. 5-62264, the flange portion of the dilator hub of the aforementioned Japanese Utility Model Laid-Open No. 5-56153 is formed into a polygon and the end of the sheath hub engaging with the polygon is also formed into a polygon. The thing which can also prevent the movement of is disclosed.
[0009]
[Problems to be solved by the invention]
As described above, various methods for fitting the dilator part and the sheath part are disclosed, but it cannot be said that the fitting method is suitable for the purpose of going through the steps of insertion → treatment → removal. is the current situation. In other words, the conventional mating method has been proposed to fit the dilator hub and the sheath hub firmly or securely, and it is not sufficient for the ease of removal at the time of removal. It is the present situation that does not have the characteristics of.
[0010]
For example, the taper fitting method shown in (1) is very advantageous for the removal of the dilator hub and sheath hub, which is the final step, but a certain amount of force was applied in the axial direction during insertion. In this case, the fitting force is weak and unstable.
[0011]
In addition, although the screw-like fitting method shown in (2) is the most excellent method for preventing the movement in the axial direction and the rotational direction, It is optimal for maintaining a strong mating state, and excels in stability during insertion and treatment, but it needs to be rotated considerably during removal during removal, and when mating There is troublesome alignment between the dilator hub and the sheath hub.
[0012]
In addition, the method shown in (3) is quite effective in preventing this axial movement and rotational movement. It is necessary to provide a sufficient distance to the surface, and as a result, the distance from the sheath portion to the end surface of the dilator portion is large, and it is difficult to insert the guide wire or catheter.
[0013]
In addition, the method (4) is effective for the effect of preventing the movement in the axial direction and is advantageous at the time of insertion and treatment, but when the dilator hub and the sheath hub are fitted, the dilator hub and the sheath hub are removed. When it is difficult to come off and the fitting protrusion on one side is always caught when trying to remove the fitting by applying a force in the direction perpendicular to the axial direction of the introducer, the dilator hub and the sheath hub are pulled out. It cannot be denied that the fitting is difficult to remove and difficult to use.
[0014]
Further, the method (5) is an effective means in terms of functional aspects such as prevention of movement in the axial direction and movement in the rotational direction, but the direction perpendicular to the axial direction of the introducer as in the case of (4) above. When removing the fitting by applying force to the inner peripheral surface of the flange portion and the outer peripheral portion of the dilator hub, a concave or convex portion for fitting is provided on the inner peripheral surface of the flange portion and the outer peripheral surface of the dilator hub. When pulling out, when applying force in a direction perpendicular to the axial direction of the introducer, only one direction is removed, but the other direction is still fitted, so it is already It cannot be denied that it requires some kind of operation and is difficult to use.
[0015]
[Means for Solving the Problems]
In order to provide an introducer in which the above-mentioned problems of the prior art are solved, the present invention provides a sheath hub with a built-in valve body in the hollow portion, a fitting groove provided on the base side of the valve body, and a dilator The hub has a flange portion that is substantially in close contact with the outer peripheral surface of the dilator hub at the end, and a locking claw for engaging with the fitting groove of the sheath hub is formed on the dilator mounting base of the dilator hub. Therefore, the dilator part and the sheath part are integrally fitted only by pushing the dilator into the sheath hub. As a result, the dilator part and the sheath part integrally respond to the movements in the axial direction and the rotational direction, and when removed, a force is applied in a direction perpendicular to the axial direction of the introducer to fit the dilator hub and the sheath hub. When removing the joint, the tip of the flange acts as a fulcrum with respect to the outer peripheral surface of the dilator hub and operates just like a lever, so the fitting part of the dilator hub and sheath hub can be easily detached with one hand, making attachment and removal easy. is there.
[0016]
In addition, the dilator hub and sheath hub are disengaged simply by applying a force in a direction perpendicular to the introducer axial direction, and operations such as rotation are not required. Since the movement of the part is minimized, the inner wall of the blood vessel is not damaged.
[0017]
Furthermore, it is more preferable that the flange portion tip contacts the outer peripheral surface of the dilator hub at substantially one point to act as a fulcrum, so that the flange portion is not a continuous peripheral surface but is divided into a plurality of peripheral surfaces. What is called a locking part or a locking claw-like shape is preferable. When a force is applied in a direction perpendicular to the axial direction of the introducer at the time of removal, the tip of the flange part comes into contact at substantially one point from any direction. It is preferable that at least four or more.
[0018]
However, as an introducer like the present invention, its size naturally has a limit, and it is reasonable to have up to about 8 divisions.
[0019]
The axial cross section of the sheath hub does not need to be circular, and the cross section of the sheath hub may be a regular polygon, and the axial perpendicular section of the flange portion of the dilator may also be a regular polygon to match the sheath hub. It is preferable from the viewpoint of preventing.
[0020]
In this case, in order to make the best use of the detachability that is the gist of the present invention, the polygon is preferably a polygon having even angles such as a square, a hexagon, and an octagon.
[0021]
Further, the flange portion of the dilator hub covering the outer peripheral surface of the sheath hub does not need to cover the entire outer peripheral surface of the sheath hub, and preferably covers at least 50% of the outer peripheral area.
[0022]
The material of the dilator hub and sheath hub employed in the present invention may be any ordinary injection molding grade resin such as polypropylene, polyvinyl chloride, polyethylene, butadiene styrene, ABS, polyamide, polycarbonate, etc. And flexibility (having some deformability) are better.
[0023]
The material used for the dilator has a certain degree of rigidity for expanding and inserting the skin and blood vessels, and is preferably a material that is not too hard to follow the guide wire inserted therein, such as polypropylene, Fluorine resin such as polyethylene and ETFE, polyamide, polyurethane and the like are used.
[0024]
The depth of the groove of the fitting portion and the height of the convex portion of the fitting portion vary depending on the required fitting force and the type of resin used, but 0.1 mm to 2. The range of 0 mm is preferable, and the range of 0.3 mm to 0.8 mm is more preferable.
[0025]
In addition, in the sheath hub and / or dilator hub in the present invention, it is preferable that a valve body made of silicon, latex, butyl rubber, isoprene rubber or the like is provided in order to prevent blood from being ejected from the dilator and the sheath when securing blood vessels. This valve body is a valve body that is cross-slit on one side and the other side and intersects only inside, but if the valve body does not leak blood, it is a multi-layered Y-shaped slit, It may be a duck bill valve having a cross or a single slit, or any other known valve body.
[0026]
In the sheath hub of the present invention, it is also preferable that a tube with a three-way stopcock or the like is attached to the other end for injecting physiological saline or physiological saline containing an anticoagulant such as heparin into the side portion. A certain sheath hub and sheath are usually directly attached, but communicated with each other through an elastic member such as silicon, rubber, thermoplastic elastomer or a tube made of silicon, butyl rubber, polyvinyl chloride, polybutadiene, polyurethane, etc. In some cases, it is indirectly connected in a state.
[0027]
Further, the sheath hub has a groove and / or a ring as a distal end side or a separate member, for example, for applying a suture to place the sheath hub on the patient after securing a blood vessel on a support for preventing kinking (bending) of the sheath. It is also preferable to provide a thread hanging piece. The material used as the sheath support is preferably a styrene-based, olefin-based, or polyester-based thermoplastic elastomer from the viewpoint of preventing kinking of the sheath body.
[0028]
The sheath body has a tubular shape, and the tip of the sheath is reduced in diameter by the first taper in the same manner as in the most advanced part of the dilator, and is reduced by forming a second taper having a larger angle than the first taper at the most advanced part. It has a diameter. With such a configuration, the level difference from the tip of the dilator body is extremely small, and the resistance when inserted into the blood vessel is small, so-called sharpness is improved. The sheath body preferably has an inner diameter of 1 mm to 10 mm, an outer diameter of 1.2 mm to 11 mm, and a wall thickness of about 0.1 mm to 0.5 mm.
[0029]
The material of the sheath body is preferably a material that has a certain degree of rigidity for introduction into the blood vessel, and that can take a large internal lumen, that is, can be thinned. Moreover, in order to percutaneously place in a blood vessel, it is necessary to be a thing excellent in biocompatibility. Considering these points, thermoplastic elastomers such as ETFE, PTFE, PFA, FEP, PVDF, PCTFE, and ECTFE are suitable, and ETFE is most suitable from the viewpoint of maintaining rigidity while being thin. Let's go.
[0030]
In addition, since the sheath body is used for confirming the blood vessel introduction position, it is more preferable that the sheath body contains a contrast-enhancing material such as bismuth oxide, barium sulfate, white bismuth oxide, or tungsten.
[0031]
[Action]
The introducer of the present invention is configured as described above, and when the introducer with the dilator portion is inserted into the blood vessel, a flange portion is formed at the end of the dilator hub, and the die of the dilator hub is formed. By having a locking claw for engaging with the fitting groove of the sheath hub in the lator mounting base, the dilator part and the sheath part are integrated only by pushing the dilator through the valve body provided in the sheath hub. To fit. As a result, the flange portion can be integrated with the movement in the axial direction and the rotational direction, and when removing the fitting between the dilator hub and the sheath hub by applying a force in the direction perpendicular to the axial direction of the introducer during removal. Since the tip of the shaft serves as a fulcrum with respect to the outer peripheral surface of the dilator hub and operates just like a lever, the fitting portion between the dilator hub and the sheath hub can be easily detached and easily attached / detached with one hand.
[0032]
In addition, the dilator hub and sheath hub are disengaged simply by applying a force in a direction perpendicular to the introducer axial direction, and operations such as rotation are not required. Since the movement of the part is minimized, the inner wall of the blood vessel is not damaged.
[0033]
【Example】
FIG. 1 is an overall view of an introducer according to the present invention. FIG. 2 shows an enlarged view of the fitting portion between the dilator portion and the sheath portion of the introducer of the present invention.
[0034]
Then, although the introducer of this invention is demonstrated along drawing, it cannot be overemphasized that this invention is not limited to this Example, if the meaning is not impaired.
[0035]
As shown in FIG. 1, the introducer 1 of the present invention is provided with a flange 21 at the end of the dilator hub 2, and the dilator mounting base of the sheath hub 3 is engaged with the fitting groove 33 of the dilator hub. The locking claw 22 is provided. By inserting the dilator 23 into the sheath hub 3 and pushing the dilator 23 as it is, the fitting groove 33 and the locking claw 22 are fitted, whereby the dilator part and the sheath part are fitted together.
[0036]
On the other hand, when the dilator is removed after any procedure is completed, a force is applied in a direction perpendicular to the axial direction of the introducer, and the dilator hub and the sheath hub are first disengaged. Since the tip acts as a fulcrum with respect to the outer peripheral surface of the dilator hub and operates just like a lever, the fitting portion between the dilator hub and the sheath hub can be easily detached and attached easily with one hand.
[0037]
【The invention's effect】
As described above, the introducer of the present invention is provided with a flange-like portion at the end of the dilator portion, and the dilator mounting base portion of the dilator hub has a locking claw for engaging with the fitting groove of the sheath hub. Therefore, the dilator part and the sheath part are integrally fitted only by pushing the dilator into the sheath hub. As a result, the dilator part and the sheath part integrally respond to the movements in the axial direction and the rotational direction, and when removed, a force is applied in a direction perpendicular to the axial direction of the introducer to fit the dilator hub and the sheath hub. When removing the joint, the tip of the flange acts as a fulcrum with respect to the outer peripheral surface of the dilator hub, and operates just like a lever. is there. Further, at this time, there is an effect that the inner wall of the blood vessel is not damaged because the movement of the tip portion of the dilator and the sheath is suppressed to the minimum because no rotation operation or the like is involved.
[Brief description of the drawings]
FIG. 1 is an overall view showing an embodiment of an introducer according to the present invention.
FIG. 2 is an enlarged view of a fitting portion of the introducer of the present invention.
FIG. 3 is a component diagram showing a dilator portion of the introducer of the present invention.
FIG. 4 is an overall view showing one embodiment of the introducer of the present invention.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Introducer 2 Dilator hub 3 Sheath hub 32 Sheath 33 Fitting groove 4 Support body 41 Thread hook piece 42 Thread hook groove 5 Valve body

Claims (4)

An inner tube portion comprising an inner tube hub having an inner tube and a hollow portion communicating with the inner tube and connected to the inner tube; and an outer tube having a hollow portion communicating with the outer tube and connected to the outer tube The outer tube hub is configured by an outer tube portion, and the outer tube hub incorporates a valve body in the hollow portion, a fitting groove is provided on the base side of the valve body, and the inner tube hub is formed at the end portion. A flange portion having a peripheral surface substantially in close contact with the outer peripheral surface of the outer tube hub and divided into four or more parts is formed, and a fitting groove of the outer tube hub is formed on an inner tube mounting base of the inner tube hub. An introducer having a locking claw for engaging. The introducer according to claim 1, wherein the flange portion of the inner pipe hub covering the outer peripheral surface of the outer pipe hub covers at least 50% of the outer peripheral area of the outer pipe hub. The introducer according to claim 1 or 2, wherein the outer tube hub and the flange portion have an axially perpendicular cross section. The introducer according to claim 3, wherein the regular polygon has an even number of corners.

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