JP2020044613A - Cutting blade and method for manufacturing medical valve body with use thereof - Google Patents

Abstract

To provide a cutting blade which can form a slit in an elastic thin film with high dimensional accuracy, and a method for manufacturing a valve body with use of the cutting blade.SOLUTION: A cutting blade 10 which is inserted in one face 21a of an elastic thin film 20 from a vertical direction Z, and is caused to penetrate to the other face 21b of the elastic thin film 20, thereby forming a linear slit 22. The cutting blade 10 comprises a base body part 11 and a blade tip. The base body part 11 has two end parts 12, 13 which are parallel to the cutting blade 10 insertion direction Z, has blade tips 12a, 13a and 14a at two end parts 12, 13 and an end part 14 on an insertion side of the elastic thin film 20, and has at least one a blade peak 15 at the end part 12 on the insertion side.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a cutting blade and a method for manufacturing a medical valve body using the cutting blade.

  In the medical field, a three-way stopcock or a Y-shaped connector is connected to a catheter for administering a drug solution, transfusion, or the like, for performing co-infusion of a drug solution or the like. The three-way cock and the Y-shaped connector are provided with a medical connector to enable connection of a male connector such as a syringe. The medical connector is provided with a medical valve element in which a slit is formed in an elastic body so that the connection port is always liquid-tightly sealed, and the connection port is opened only when necessary to administer a medical solution or the like. Such a medical valve element has high sealing properties because the slit inner surfaces are in close contact with each other.

As a medical valve body having a slit, for example, Patent Literature 1 discloses a disc-shaped elastic body provided with a cross slit. The slit of the medical valve body described in Patent Literature 1 is formed by winding a valve material around a cylindrical body and making a cut with a blade at right angles to the cylindrical axis direction. It is described that a slit having a different opening width is formed on one end face and the other end face in the axial direction of the opening, thereby improving the sealing performance.
Patent Literature 2 discloses an elastic valve body in which a disk-shaped elastic body is provided with slits branched in three directions from an axial center. The slit of the elastic valve body described in Patent Literature 2 is formed by pressing a cutter having a cutting edge having the same shape as the slit from a vertical direction against the elastic body and penetrating it.

Japanese Patent No. 2510887 JP 2014-046271 A

Since the slit of the medical valve body is formed with an opening width such that there is no gap between the inner surface of the slit and the syringe in order to prevent liquid from leaking from between the slit and the syringe, insert the syringe into the slit. In this case, a large insertion resistance occurs. Further, if the cut surface of the slit is rough, the insertion resistance is increased, and the slit is easily deteriorated by inserting and removing the syringe.
In the above-mentioned patent document, since the blade edge forms a slit using a cutter parallel to the slit forming surface of the valve body, when the blade is pushed in, the elastic body is curved and deformed, and the cut surface becomes rough, Alternatively, there is a problem that a slit different from a desired size is formed.

  The present invention has been made in view of the above circumstances, and has a cutting blade capable of forming a slit with high dimensional accuracy in an elastic thin film, and a medical use having high dimensional accuracy and sealing performance using the cutting blade. An object of the present invention is to provide a method of manufacturing a medical valve element for manufacturing a valve element.

The cutting blade of the present invention,
A cutting blade that pierces one surface of the elastic thin film from a vertical direction and penetrates to the other surface of the elastic thin film to form a linear slit,
Consists of a base and a cutting edge,
The base has two ends parallel to the direction in which the cutting blade is inserted,
It has a cutting edge at two ends and an end on the side that pierces the elastic thin film,
It has at least one ridge at the end on the side to be stabbed.

  The thickness of the cutting blade is preferably 0.2 mm or more and 0.4 mm or less.

The cutting blade of the present invention has two blade ridges at the end on the side to be inserted,
The vertices of the two blade ridges may be located on two ends of the base portion, respectively.

The manufacturing method of the medical valve body of the present invention is made of an elastic thin film, and comprises an inverted truncated cone-shaped valve body having a concave portion on the inside, and a flange portion projecting outward from an open end of the valve body, A method for manufacturing a medical valve body having a linear slit on the bottom surface of the concave portion,
A first step of vulcanizing and molding the rubber composition to integrally form the valve body and the flange,
The cutting blade of the present invention, piercing vertically from the opening of the recess toward the bottom surface, the second step of forming a slit through the bottom surface,
Is provided.

The bottom of the recess is rectangular,
In the second step, it is preferable to insert the cutting blade so that the cutting blade and the long side of the bottom face are parallel.

According to the cutting blade of the present invention, it is possible to form a slit in the elastic thin film with high dimensional accuracy.
Further, according to the method for manufacturing a medical valve element of the present invention, since the cutting blade of the present invention is used, a medical valve element having high dimensional accuracy and high sealing performance can be obtained.

It is a side view which shows the process of forming a slit in an elastic thin film using one Embodiment of the cutting blade of this invention. It is a side view of one embodiment of a cutting blade of the present invention. It is a front view showing other embodiments of a cutting blade of the present invention, and an elastic thin film. It is one Embodiment of a medical valve body, It is a perspective view before forming a slit. It is one embodiment of the medical valve body, and is a plan view before forming a slit. It is AA sectional drawing in FIG. FIG. 6 is a sectional view taken along line BB in FIG. 5. It is sectional drawing which shows the manufacturing method of the medical valve body of this invention. It is a top view of the medical valve element manufactured by the manufacturing method of the medical valve element of the present invention.

  Hereinafter, embodiments of the present invention will be described in detail. However, the following embodiments are presented for illustrative purposes, and the present invention is not limited to the embodiments described below.

[Cutting blade]
First, the cutting blade of the present invention will be described. FIG. 1 shows a step of forming a slit in an elastic thin film using one embodiment of the cutting blade of the present invention. FIG. 2 shows a side view of one embodiment of the cutting blade of the present invention.
As shown in FIG. 1, the cutting blade 10 according to the present embodiment pierces one surface 21 a of the elastic thin film 20 from a vertical direction (Z in the figure) and penetrates to the other surface 21 b of the elastic thin film 20 to form a straight line. Is formed.
The cutting blade 10 of the present embodiment includes a base portion 11 and a cutting edge. The base portion 11 has two ends 12 and 13 that are parallel to a direction Z in which the cutting blade 10 is inserted. Each of the two ends 12 and 13 and the end 14 on the side where the elastic thin film 20 is pierced have cutting edges 12a, 13a and 14a, respectively. Have one.
When the cutting edge 14a of the end portion 14 and the cutting edges 12a and 13a of the two end portions 12 and 13 are sequentially inserted into the elastic thin film 20 (see FIG. 1B), a linear slit 22 is formed. (See FIG. 1 (c)).

  Since the cutting blade 10 of the present embodiment has the blade ridge 15, the apex 15 t of the blade ridge 15 first contacts the elastic thin film 20, and then the cutting edge 14 a and the cutting edges 12 a and 13 a pierce the elastic thin film 20 sequentially. As a result, the elastic thin film 20 can be reduced in the area where the elastic thin film 20 bends and deforms, as compared with a conventional cutting blade having a cutting edge having a cutting edge parallel to the surface of the elastic thin film. Further, since the cutting blade 10 has the cutting edges 12a and 13a at the ends 12 and 13 parallel to the piercing direction Z, the slit 22 can be formed to a desired size. Furthermore, the end 22a (see FIG. 1C) in the length direction of the slit 22 can be formed smoothly and linearly. If the surface of the cut is rough, the syringe may be broken and the like may easily break due to the insertion and removal of the syringe, but the cut is smooth and straight, so it is difficult to break and the case where the syringe is not inserted into the slit Hermeticity can also be improved.

The width d (see FIG. 1A) of the cutting edges 12a, 13a, and 14a is preferably 0.2 mm or more and 1.5 mm or less.
In addition, the length L ₁ of the cutting blade 10 (see FIG. 1 (a)) can be considered in consideration of the fact that the outer diameter of a syringe or the like inserted into the slit, which is generally used in the medical field, is 4 mm or more and 10 mm or less. It is preferably 4.5 mm or more and 6.0 mm or less.

As shown in FIG. 2, the thickness _{t 1} of the cutting blade 10 is preferably 0.2mm or more 0.4mm or less. For example, when a slit is formed in an elastic thin film such as a medical valve body, when a syringe is not inserted into the slit, it is necessary to close tightly so that a drug solution or the like does not flow backward, but when inserting a syringe, It is necessary to make it easy to pass through the slit and not to leak a chemical solution or the like from a gap with the syringe. From this point of view, the thickness t ₁ of the cutting blade 10 is preferably in the above range.

Next, another embodiment of the cutting blade of the present invention will be described. FIG. 3 shows a front view of the cutting blade and the elastic thin film. The cutting blade 30 according to the present embodiment has two blade ridges at the end portion 34 on the piercing side.
As shown in FIG. 3, the cutting blade 30 according to the present embodiment includes a base portion 31 and a cutting edge, and has two ends 32 and 33 that are parallel to the direction Z in which the cutting blade 30 is inserted, and the elastic thin film 20. The cutting edge 32 has a cutting edge 32a, 33a and 34a, respectively, and the cutting end 34 has two blade ridges 35 and 36. The vertices 35t and 36t of the blade ridges 35 and 36 are located on the two ends 32 and 33 of the base portion 31, respectively.

Since the vertices 35t and 36t of the blade ridges 35 and 36 are located on the ends 32 and 33 of the base 31, when the cutting blade 30 is inserted, first, the vertices 35t and 36t come into contact with the elastic thin film 20, The elastic thin film 20 can be fixed at these two points. And since the cutting blade 30 has the cutting edges 32a and 33a at the two ends 32 and 33 parallel to the direction Z in which the cutting blade 30 is inserted, the length of the slit 22 is set to can be the same as the length L ₁ of the end portion 34, it is possible to form the slit 22 with high dimensional accuracy. Furthermore, the cutting edges 32a and 33a make it possible to smoothly straighten the cut edge of the end 22a in the length direction of the slit 22.
The length of the slit 22 is preferably 4.5 mm or more and 6.0 mm or less in consideration of the fact that the outer diameter of a syringe or the like generally used in the medical field is 4 mm or more and 10 mm or less.

  In the above two embodiments, the case where the piercing-side ends 14 and 34 have one and two blade ridges, respectively, may be three or more. When two or more blade ridges are provided, the vertices of the blade ridges are parallel to the piercing direction Z from the viewpoint of smoothing the cut end of the longitudinal end 22a of the slit 22 and increasing the dimensional accuracy. It is preferably located above.

[Method of manufacturing medical valve body]
Next, a method for manufacturing a medical valve body will be described. FIG. 4 shows a perspective view of an embodiment of the medical valve element before forming a slit, and FIG. 5 shows a plan view. FIG. 6 shows a sectional view taken along the line AA in FIG. 5, and FIG. 7 shows a sectional view taken along the line BB in FIG.
As shown in FIG. 4, the medical valve element 40 before forming the slit, which is manufactured by the method for manufacturing a medical valve element according to the present invention, includes an inverted truncated cone-shaped valve body 42 having a concave portion 41 inside. And a flange 43 projecting outward from an open end 42c (see FIG. 6) of the valve body 42.
As shown in FIGS. 6 and 7, the bottom surface 44 of the concave portion 41 is a rectangular thin film having a length L ₃ , a width W ₃ , and a thickness t ₃ . Considering that the outer diameter of a syringe or the like to be inserted into the slit, which is generally used in the medical field, is 4 mm or more and 10 mm or less, the length L ₃ of the bottom surface is preferably 5 mm or more and 12 mm or less. width _{W 3} of 44 is preferably 0.3mm or more 1.0mm or less.
The thickness t ₃ of the bottom surface 44 is preferably 0.5 mm or more and 1.5 mm or less, and more preferably 0.8 mm or more and 1 .2 mm or less is more preferable.

  The valve body 42 has four side surfaces, and the two opposing side surfaces 42a are flat as if the curved side surfaces of the inverted truncated cone were cut off as shown in FIGS. As shown in FIGS. 4 and 5, the two side surfaces 42b have an inverted truncated cone shape.

Next, a method for manufacturing the medical valve body of the present invention will be described. FIG. 8 is a cross-sectional view illustrating the method for manufacturing a medical valve body of the present invention. FIG. 9 is a plan view of a medical valve body manufactured by the method for manufacturing a medical valve body of the present invention.
(First step)
The valve body 42 and the flange 43 are integrally formed by vulcanizing and molding the rubber composition.
As the rubber component of the rubber composition, silicone rubber is preferable. The JIS A hardness of the silicone rubber is preferably 30 or more and 70 or less, more preferably 40 or more and 60 or less. The elongation at break of the silicone rubber is preferably 300% or more and 700% or less.

(Second step)
As shown in FIG. 8A, the medical valve element 40 formed in the first step and having no slit is set on the base 50 with the concave portion 41 facing upward. The cutting blade 10 is arranged above the medical valve body 40 where no slit is formed, and the cutting blade 10 and the long side 44a of the bottom surface 44 are adjusted so as to be parallel. The length L ₁ (see FIG. 1) of the cutting blade 10 is the same as the length L ₃ (see FIG. 6) of the long side 44a (see FIG. 5) of the bottom surface 44.
Next, as shown in FIG. 8B, a slit 45 is formed by penetrating the bottom surface 44 from the opening of the concave portion 41 toward the bottom surface 44 in the vertical direction (Z direction).
Finally, as shown in FIG. 8C, by extracting the cutting blade 10 from the bottom surface 44 of the medical valve body 40, a slit 45 is formed at the center of the bottom surface 44 as shown in FIG.

In the present embodiment, the pedestal 50 is formed so as to have a gap 51 below the bottom surface 44 when the medical valve element 40 having no slit is set. When the pedestal 50 is made of metal, it is preferable to provide the gap 51 so that the blade ridge 15 of the cutting blade 10 does not collide with the pedestal 50.
The pedestal 50 may be an elastic body. In the case of an elastic body, it is not necessary to provide the gap 51, and the bottom surface 44 of the medical valve body 40 may be in contact with the pedestal 50. In this case, the cutting edge 15 of the cutting blade 10 can be inserted into the pedestal 50. Since the bottom surface 44 of the medical valve body 40 is in contact with the pedestal 50, the bending deformation of the medical valve body 40 can be reduced, and the dimensional accuracy can be increased.

10, 30 Cutting blade 11, 31 Base part 12, 13, 14, 32, 33, 34 End part 12a, 13a, 14a, 32a, 33a, 34a Blade tip 15, 35, 36 Blade tip 15t, 35t, 36t Apex 20 Elasticity Thin film 21a One surface 21b The other surface 22 Slit 22a End 40 Medical valve element 41 Depression 42 Valve body 42a, 42b Side 42c Open end 43 Flange 44 Bottom 44a Long side 45 Slit 50 Base 51 Void

Claims (5)

A cutting blade that pierces one surface of the elastic thin film from a vertical direction and penetrates to the other surface of the elastic thin film to form a linear slit,
Consists of a base and a cutting edge,
The base has two ends parallel to a direction in which the cutting blade is inserted,
It has a cutting edge at the two ends and the end on the side to pierce the elastic thin film,
A cutting blade having at least one blade ridge at an end on the piercing side.   The cutting blade according to claim 1, wherein the thickness of the cutting blade is 0.2 mm or more and 0.4 mm or less. It has two blade ridges at the end on the piercing side,
The cutting blade according to claim 1, wherein vertices of the two blade ridges are respectively located on the two ends of the base portion. An inverted frustoconical valve body having a concave portion on the inside made of an elastic thin film, and a flange portion protruding outward from an open end of the valve body portion, and having a linear slit on the bottom surface of the concave portion. A method for manufacturing a medical valve element,
A first step of vulcanizing and molding a rubber composition to integrally form the valve body and the flange,
A second step of inserting the cutting blade according to any one of claims 1 to 3 vertically from the opening of the recess toward the bottom surface, and penetrating the bottom surface to form the slit.
A method for manufacturing a medical valve body comprising: The bottom surface of the recess is rectangular,
The method for manufacturing a medical valve body according to claim 4, wherein in the second step, the cutting blade is inserted so that the cutting blade and a long side of the bottom surface are parallel to each other.

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