JPH054843Y2 - - Google Patents

Description

[Detailed explanation of the idea]

[Industrial Application Field] The present invention relates to a hemostasis valve for a catheter introducer used for percutaneously introducing an angiography catheter into a blood vessel. [Prior Art] Angiography catheters are widely used for diagnosis and treatment of internal organs and blood vessels. Such a catheter is inserted into a blood vessel by fitting it onto a guide wire that has been previously inserted into a blood vessel, inserting a dilation tube, and then inserting it to the desired position within the blood vessel. It is inserted into the blood vessel through the cap, through the main body, and through the sheath at the tip. A hemostasis valve is provided inside the main body to prevent blood from flowing out through these when these are inserted into a blood vessel. The hemostasis valve is tightly attached to the outer circumferential surface of the dilation tube or catheter to prevent blood from flowing out, and at the same time, there is little resistance when moving these things in and out, and especially when the catheter is rotated in a predetermined direction at the target site. Small size is required. For this purpose, a hemostasis valve is composed of a single disc-shaped valve body made of synthetic resin or synthetic rubber that is flexible and elastic and has an appropriate thickness, and can be used for guide wires, dilation tubes, and catheters of different diameters. It has been considered to provide cross-shaped cuts to ensure sufficient adhesion (see Japanese Patent Laid-Open No. 133877/1983).
However, while simply making a cut has excellent hemostasis, it creates a large resistance to the insertion and removal and rotation of dilation tubes and catheters, resulting in poor operability. It has been proposed to form a concave portion to increase the flexibility of the central portion through which the expansion thin tube passes (see Japanese Patent Application Laid-open No. 1-139077 and Japanese Utility Model Application No. 1-87746). However, with a hemostasis valve with a structure in which cuts and recesses are provided in the valve body, the operability of inserting and removing the expansion tube is considerably improved, but if it is more flexible than necessary, it may not be possible to maintain a tight contact state when rotated. The valve body is pulled and rotated with it, which increases the resistance and does not improve the rotational maneuverability as expected, especially when delicate precision is required to rotate the catheter in a predetermined manner at the target site. [Problem to be solved by the invention] The problem to be solved by the invention is that, according to the conventional hemostasis valve, which uses cuts and recesses to improve adhesion and flexibility, it is impossible to achieve delicate precision. The problem is that the rotational operability, which is required by the patient, has not been improved as much as expected, and is unsatisfactory for catheters that require delicate manipulation. [Means for Solving the Problems] In order to solve the above problems, the present invention provides a pore in the center of the valve body, a conical recess on one surface, and a conical recess on the opposite surface. A Y-shaped or cross-shaped cut is formed by aligning the intersection point with the center of the pore, and the tip of the recess and the cut are communicated through the pore, and further, ribs are arranged in the recess in a Y-shaped or cross-shaped cut. By this means, the purpose of significantly improving the rotational operability of the catheter was achieved. [Function] When inserting the expansion tube or catheter into the hemostasis valve fixed by the cap fitted to the main body, the insertion point has greater flexibility due to the recesses and cuts, and the pores and cuts are continuous. Since it is provided as a holder, there is little resistance to putting it in and taking it out. In addition, the flexibility is reduced by the parts divided by the cuts, and since it is not excessively flexible, there is little resistance to rotation. [Example] An example of the present invention will be described with reference to the drawings.
In FIG. 1 showing an exploded view of an example of a catheter introducer, 1 is a cylindrical body having a nozzle 3 for attaching a sheath 2 to the tip and a nozzle 4 for attaching a heparin injection tube to the side, and 6 is a cylindrical body having a nozzle 4 for attaching a heparin injection tube to the side. A cap 11 having a small hole 7 is fitted and fixed to the base of the main body 1, and a hemostasis valve 11 is stacked on the base end of the main body 1 and is held and fixed by the cap 6. Referring to FIG. 2, the hemostasis valve 11 consists of a valve membrane body 12 formed into a disk shape with an appropriate thickness from a plastic elastic material such as polyurethane elastomer, polyamide elastomer, natural rubber, synthetic rubber, silicone rubber, etc.
A conical recess 13 is formed on one surface leaving an outer peripheral edge, and a central recess 13 is formed.
A pore 14 of an appropriate length is provided from the tip, and a Y-shaped cut 15 is provided at a depth that reaches the pore 14 on the opposite surface. The intersection of the cuts 15 is the pore 14
The outer edge of the recess 13 is located at the center of the recess 13, and its outer edge substantially coincides with the outer periphery of the recess 13. Moreover, three ribs 16 are formed protrudingly in a Y-shape on the inclined surface of the recess 13 and positioned in the middle of the cut 15. In this embodiment with such a configuration, the pores 14
has a slightly smaller diameter than the diameter of the guide wire that guides the dilation tube, etc., and when the concave portion is fixed to the main body 1 with the concave portion facing toward the proximal end, that is, the cap 6, and the dilation tube or catheter is inserted, the concave portion 13 The valve membrane body 12 can be easily expanded because the pores 14 and the slit 15 with the intersection point located at the center are continuously provided in the part where the pores 14 and the slit 15 are located at the center of the pores, which have extremely high flexibility due to the thin wall. In addition, the contact area is small and it can be inserted and removed with little resistance. Next, when the tip of the catheter is rotated in order to orient it in a predetermined direction at the target site, if the center portion of the valve body 12 that is in close contact with the outer circumferential surface is excessively flexible, it will be stretched, and the cut 15 will be formed. However, since the ribs 16 reinforce the thinned portions due to the recesses 13 and provide appropriate flexibility, the torsion is reduced and rotation is made with less resistance. be able to. The rib 16 is provided in the recess 13 disposed on the proximal end side, and is provided on the tension side when the valve body 12 is bent toward the distal end when inserting a thin dilation tube, etc., so that the insertion is smooth. However, if the valve membrane body 12 is to be bent toward the proximal end when being pulled out, since it is provided on the compression side, the bending will be hindered, the resistance to pullout will increase, and the insertion/removal operation will be slightly reduced. However, when the rib 16 is provided in the recess 13, when the catheter is inserted and rotated, the rib 16 of the recess 13, which is bent toward the distal end and has a smaller inclination angle, comes into contact with the outer peripheral surface of the catheter. Since the surfaces do not come into direct contact, there is little increase in resistance, and together with the small twist as mentioned above, the rotational operability is good. FIG. 3 shows a different embodiment of the hemostasis valve 11, in which a Y
Three ribs 16 are formed protruding in the same phase as the cut 15 in the shape, and the cut 15 is formed on the opposite surface.
It is the same as the one shown in FIG. 2 in that it has three ribs 17 protruding in a Y-shape located in the middle of the recess 13, and has a pore 14 extending from the tip of the recess 13 to the cut 15. According to this embodiment, the flexibility of the thin center portion is lower than that of the one shown in FIG. 2, and the operability of putting it in and taking it out is slightly lowered, but the hemostasis is extremely good. FIG. 4 shows a still different embodiment of the hemostasis valve 11, in which four ribs 16 are formed protruding in a cross shape on the inclined surface of the recess 13 of the valve body 12, and ribs are formed on the opposite surface. Four ribs 17 are formed to protrude in a cross shape and are out of phase with the ribs 16 by 45 degrees, and cuts 15 that are in the same phase as the ribs 17 are formed in a cross shape. The provision of holes 14 is the same as in FIGS. 2 and 3. Although the flexibility of the thin center portion of this example is lower than that of the one shown in FIG. 2, and the operability of putting in and taking out is slightly lower, the hemostasis is extremely good. Next, the embodiments shown in FIGS. 2, 3, and 4 of the present invention are referred to as products 1, 2, and 3 of the present invention, which have a recess 13, a pore 14, a Y-shaped cut 15, and ribs 16, 1.
The results of testing the hemostatic properties, ease of putting in and taking out, and rotary workability with Comparative Product 1 which does not have 7 and Comparative Products 2 and 3 which are conventional products shown in FIGS. 5 and 6 will be described. Products 1, 2, and 3 of the present invention and comparative product 1 are made by mixing and defoaming two-component silicone resin, placing it in a mold, and heating and solidifying it.
center depth 0.5mm, diameter of pore 14 0.8mm, pore 1
The depth of 4 was set to 0.3 mm. Comparative product 2 has a pore 22 in one of the two valve bodies 21, 23 and a Y-shaped cut 24 in the other, and comparative product 3 has a radius in each of the three valve bodies 25, 27, 29. Upper cut 26, pore 28, U-shaped cut 3
0, and the material, diameter, and thickness of these valve leaflets are the same as above. These were fixed to the main body 1 shown in Fig. 1 with a cap 6, and a guide wire with a diameter of 0.9 mm and an outer diameter of 2.3
A hemostasis (airtightness) and operability test was conducted under an air pressure of 500 mmg using a 3 mm catheter, and the evaluations shown in the following table were obtained. However, 5 represents extremely good, 4 represents good, 3 represents slightly poor, and 2 represents poor.

[Table] [Effects of the invention] According to the invention, the insertion part of the dilation thin tube of the valve body has increased flexibility due to the recess and the cut, and the pore and the cut are continuous and the cut is Since the intersection point is located on the center of the pore, the resistance to insertion and removal is reduced, and the insertion and insertion can be smoothly guided, resulting in good operability of insertion and removal. In addition, by providing ribs in the thinner part of the recess, it does not become excessively flexible, and the resistance when rotating is small, making delicate rotation operations easier. When the angle is small, the increase in contact resistance is smaller than when the rib contacts the catheter and the sloped surface of the recess itself contacts, and rotational operability is not deteriorated.

[Brief explanation of the drawing]

Fig. 1 is an exploded longitudinal sectional view of an example of a catheter introducer, Fig. 2 shows a first embodiment of a hemostasis valve, A is a plan view, B is a longitudinal sectional view, and Fig. 3 is a second embodiment of the hemostasis valve. An example is shown in which A is a plan view, B is a longitudinal sectional view, and FIG. 4 is a third embodiment of a hemostasis valve, A is a plan view, and B
5 is a longitudinal sectional view, and FIGS. 5 and 6 are perspective views of the conventional example. 1 body, 6 cap, 11 hemostasis valve, 12 valve body, 13 recess, 14 pore, 15 cut, 16,1
7 ribs.

Claims (1)

[Scope of utility model registration request] A hemostasis valve for a catheter introducer that is fitted into a cylindrical body having a sheath attached to the distal end and a cap attached to the proximal end and fixed by the cap, and is composed of a disc-shaped valve body, The valve body has a conical recess formed on one surface, and a Y-shaped or cross-shaped cut on the opposite surface. A hemostasis valve, wherein a pore is provided that is centered at the intersection and communicates with the cut, and the recess is further provided with ribs arranged in a Y-shape or a cross-shape.