JP2017030079A - Punching device and gasket punched by its device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a punching device 20 for excellently punching a product (a gasket 10) when punching the product (the gasket 10) connected by a molding sheet 30.SOLUTION: A punching device 20 comprises a lower blade 22 and an upper blade 25, and punches a product from a molding sheet 30 by sandwiching the lower blade 22 and the upper blade 25 together, by arranging the product connected by the molding sheet 30 between the lower blade 22 and the upper blade 25. In the punching device 20, the lower blade 22 or the upper blade 25 includes an inner edge angle 251 positioned on the product cutting surface side for cutting the outer edge of the product and an outer edge angle 252 positioned on the outside of the product cutting surface side, and an angle radius is imparted to the outer edge angle 252.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a molded product such as a gasket applied to a medical syringe and a punching device for punching the molded product from a molded sheet.

As a syringe used for medical use, there is a syringe (referred to as a “prefilled syringe”) filled with a liquid medicine in advance. In the prefilled syringe, the syringe tip is sealed with a rubber cap, the syringe is filled with a chemical solution, and the back end of the syringe is plugged with a gasket.
As the gasket used for the prefilled syringe, a product called a laminated gasket in which the surface is laminated with an inert film having good sliding property is often used. A gasket with a wetted surface and a contact surface with a syringe laminated with an inert film (laminate), even if there is no silicone on the inner wall of the syringe or the gasket surface, the user can use the prefilled syringe without difficulty with one hand. Can move the gasket. This is because the friction resistance of the inert film is small.

On the other hand, the gasket manufacturing process includes a process of punching a molded product from a sheet and making it individual. The product punched out by this process has a cut surface portion from the molded sheet (hereinafter, this cut surface portion is referred to as a “punched burr portion”).
An inert film is not laminated on the punched burr, and the rough rubber surface is exposed. For this reason, when a punching burr | flash part contacts a syringe inner wall, the sliding resistance value of a gasket will rise rapidly, and the usability as a prefilled syringe will deteriorate.

In order to prevent the punching burrs from coming into contact with the inner wall of the syringe, in the punching process of punching the product (gasket) from the molded sheet, so-called tension punching is performed in which the product is punched while applying tension to the molded sheet (for example, in Patent Document 1). , Tension removal is introduced.) Need to be implemented.
However, even when the tension release is performed, there is a possibility that the punching burr part and the syringe inner wall come into contact with each other. This is because when punching is performed in a state where a non-uniform tension is applied to the circumferential direction of the product (gasket), or by cutting the inert film on which the punching blades are laminated, This is the case when the desired tension is not applied.

JP 2012-147859 A

  When manufacturing a gasket in which an inert film is laminated on the liquid contact surface side, the inert film is laminated across both the product portion and the burr portion of the molded sheet. Therefore, it is a problem to be solved by the present invention to provide a punching device that can punch through products (gaskets) well when punching out products (gaskets) connected by a molded sheet.

The solution means of the present invention for solving the above-mentioned problem comprises a lower blade and an upper blade, a product connected by a molded sheet is disposed between the lower blade and the upper blade, and the lower blade and the upper blade are sandwiched between them. A punching device for punching out the product from the molded sheet,
The lower blade or the upper blade includes an inner blade edge angle located on the product cutting surface side for cutting an outer edge of the product, and an outer blade edge angle located on the outer side of the product cutting surface side,
The punching device is characterized in that a corner radius is given to the outer blade tip angle.

  According to the punching device of the present invention, in the punching step of separating the product from the molded sheet, the punching can be performed without excising the inert film laminated on the burr portion, and the small inertness that is difficult to remove by washing or the like. The generation of film pieces can be suppressed. Further, the punched burr part of the product punched by this punching device (medical gasket) is punched with a uniform tension applied, so that the punched burr part does not come into contact with the inner wall of the syringe. Further, when the gasket is sucked and plugged into the syringe, the operability by the suction jig can be kept good.

FIG. 1 is an enlarged side view of a gasket according to an embodiment of the present invention, and the left half of the gasket is a cross-sectional view. FIG. 2 is a cross-sectional view showing a schematic configuration of a punching apparatus according to an embodiment of the present invention. FIG. 3 is an illustrative view showing a state in which products (gaskets) connected by a molded sheet are punched by the punching apparatus shown in FIG. FIG. 4 is a cross-sectional view showing a schematic configuration of a punching device according to another embodiment of the present invention.

1st invention of this invention is equipped with the lower blade and the upper blade, arrange | positions the product connected with the shaping | molding sheet between the said lower blade and the upper blade, and sandwiches the said lower blade and the upper blade, The said shaping | molding sheet A punching device for punching the product from
The lower blade or the upper blade includes an inner blade edge angle located on the product cutting surface side for cutting an outer edge of the product, and an outer blade edge angle located on the outer side of the product cutting surface side,
The punching device is characterized in that a corner radius is given to the outer blade tip angle.

Moreover, 2nd invention is a punching device characterized by the radius of curvature given to the said outer blade edge | tip angle | corner being 0.02 mm or more.
A third aspect of the present invention is the punching device characterized in that the radius R given to the outer cutting edge angle has a radius of curvature of 0.02 mm to 0.5 mm.
According to a fourth invention, in the first to third inventions, the product connected by the molded sheet is formed by molding a molded sheet in which an inert film is laminated on one surface of an elastic material. Device.

5th invention is a punching device in which the said product contains the gasket for prefilled syringes which the inert film was laminated | stacked on the liquid-contact part.
6th invention is the 1st-3rd invention, The blade by which the angle | corner radius was provided to the said outer blade tip angle | corner is an upper blade,
When the upper blade descends toward the lower blade, it is a punching device that applies tension to a product connected by a molding sheet disposed on the lower blade.

A seventh invention is a gasket applied to a medical syringe including a main body made of an elastic material and an inert film laminated on the surface of the main body,
The gasket includes a circumferential surface portion that contacts an inner circumferential surface of the syringe;
Formed around the rear end of the gasket, and includes a rear end cut surface portion generated when the gasket is punched from a molded sheet,
The rear end cut surface portion is a gasket having a peripheral diameter that does not contact the inner peripheral surface of the syringe.

Hereinafter, embodiments of the present invention will be described more specifically with reference to the drawings.
FIG. 1 is an enlarged side view of a gasket 10 according to an embodiment of the present invention, and the left half of the gasket 10 is shown in cross section.
Referring to FIG. 1, a gasket 10 according to this embodiment is a so-called laminate gasket including a main body 11 made of an elastic material and a laminate film 12 as an inert film laminated on the surface of the main body 11. . The main body 11 should just be comprised with the elastic material, and it does not specifically limit regarding the raw material. For example, it can be composed of a thermosetting rubber or a thermoplastic elastomer. Among these, since it is excellent in heat resistance, a thermosetting rubber or a dynamic cross-linking thermoplastic elastomer having a cross-linking point among thermoplastic elastomers is more preferable. These polymer components are also not particularly limited, and to be strong, ethylene-propylene-diene rubber and butadiene rubber excellent in moldability are preferable. Also preferred are butyl rubber, chlorinated butyl rubber, and brominated butyl rubber which are excellent in gas permeability resistance.

  The laminate film 12 laminated on the surface of the main body 11 may be a film that can prevent the migration of components from the cross-linked rubber (main body 11) and has excellent sliding properties than rubber, that is, a film having a smaller friction coefficient than rubber. For example, the type is not particularly limited. As an example, a film of ultra-high molecular weight polyethylene or fluorine-based resin that has a proven record in medical use can be mentioned. Of these, fluorine-based resins are preferable because they are excellent in slidability and surface chemical stability. As the fluororesin, a known resin may be used as long as it contains fluorine. Examples thereof include PTFE, modified PTFE, ethylene tetrafluoroethylene copolymer (ETFE), perfluoroalkyl ether (PFA), FEP. (Fluorine resin in which tetrafluoroethylene and hexafluoropropylene are jointly combined), polychlorotrifluoroethylene (PCTFE), polyvinylidene fluoride (PVDF), polyvinyl fluoride (PVF), and the like. PTFE and modified PTFE are preferable because they are excellent in both slidability and chemical stability. ETFE is preferable because of its good resistance to γ-ray sterilization. From the viewpoint of adhesiveness with the main body 11, a film made of a mixture or a laminate of these resins can also be used.

  The gasket 10 includes a circumferential surface portion 13 that is in airtight and liquid tight contact with the inner peripheral surface of the syringe, and the surface of the circumferential surface portion 13 and the liquid contact portion 14 (a tip portion positioned on the lower side in FIG. 1). ) Is covered with a laminate film 12. From the rear end surface 15 of the gasket 10, an internally threaded fitting recess 16 is formed which is carved in the axial direction. In use, the tip of the pusher is fitted into the fitting recess 16.

  The gasket 10 includes a rear end cut surface portion 17 formed around the rear end surface 15. The rear end cut surface portion 17 is a cut surface portion generated when the gasket 10 is punched from the molded sheet, and is a portion referred to as a “punched burr portion”. The reason why the punching burr 17 is inclined in the oblique direction with respect to the axial direction of the gasket 10 is because the so-called tension is removed.

  The dimensions of the gasket 10 will be described. When the diameter of the circumferential surface portion 13 is D1, the diameter of the punching burr 17 is D2, and the inner diameter of the syringe into which the gasket 10 is plugged is D0, D1> D0> D2. It has become a relationship. As a result, the circumferential surface portion 13 is pressed against the inner wall of the syringe, the chemical solution can be prevented from leaking between the syringe inner wall and the circumferential surface portion 13, and the circumferential surface portion 13 covered with the laminate film 12 does not force the inside of the syringe. Can move without. Moreover, since the punching burr | flash part 17 does not contact a syringe inner wall, the sliding resistance value of the gasket 10 does not become high.

FIG. 2 is a cross-sectional view showing a schematic configuration of the punching device 20 according to one embodiment of the present invention.
In FIG. 2, reference numeral 21 denotes a lower blade holding portion, and a cylindrical lower blade 22 is erected on the upper surface of the lower blade holding portion 21. Further, a molded sheet receiving portion 23 is provided in association with the lower blade 22. The molded sheet receiver 23 is for placing a product (gasket 10) connected by the molded sheet 30.

A cylindrical upper blade 25 suspended from the upper blade holding portion 24 is disposed above the lower blade 22. By lowering the upper blade 25 held by the upper blade holding portion 24 and sandwiching the upper blade 25 and the lower blade 22, the gasket 10 as a product can be punched out from the molded sheet 30.
The upper blade 25 has an inner blade edge angle 251 located on the product cutting surface side for cutting the outer edge of the product (gasket 10) and an outer blade edge angle 252 located outside the product (gasket 10) cutting surface side. include. In FIG. 2, as shown in the enlarged view of the portion surrounded by A, the outer blade edge angle 252 is given an angle R. This is a feature of the punching device 20 according to this embodiment.

In this embodiment, the corner radius given to the outer blade edge angle 252 has a radius of curvature of 0.02 mm or more. When the angle R given to the outer blade edge angle 252 is 0.02 mm or more, even if the molded sheet 30 is pulled so as to apply tension at the time of punching, the film of the burr portion is not cut and is small. Film pieces do not occur.
In this embodiment, the corner radius given to the outer blade edge angle 252 has a radius of curvature of 0.5 mm or less. Usually, the upper blade 25 (the same applies to the lower blade 22) wears the blade edge angle by repeated punching operations. In particular, the punching of the burr portion on which the hard inert film is laminated accelerates the wear of the upper blade 25. The worn upper blade 25 can be used again by polishing. Since this polishing polishes the lower end side of the upper blade 25, it is performed in common for the inner blade edge angle 251 and the outer blade edge angle 252, and after polishing, a process for imparting an angle R only to the outer blade edge angle 252. Must be given.

Although it is preferable as a punching characteristic even if the angle R of the outer cutting edge angle 252 is 0.5 mm or more, the process of imparting the angle R of 0.5 mm or more to the outer cutting edge angle 252 requires a lot of processing time, High costs will be incurred.
Therefore, in this embodiment, the curvature radius provided to the outer blade edge angle 252 is adjusted to have a curvature radius of 0.02 mm to 0.5 mm.

  FIG. 3 is an illustrative view showing a state in which the product (gasket 10) connected by the molded sheet 30 is punched by the punching apparatus shown in FIG. As shown in FIG. 3, when the upper blade 25 is lowered, the molded sheet 30 around the product (gasket 10) is pushed down by the upper blade 25, and tension is applied to the molded sheet 30 around the product, so-called burr. When tension is applied to the outer blade tip angle 252 when the upper blade 25 is pressed down, if the outer blade tip angle 252 is angular, the outer blade tip angle 252 does not cut the film when the tension is applied, and the entire burr portion (rubber material and film Apply tension to the whole. Thereby, the rear end cut surface portion (punching burr portion) 17 of the gasket 10 is punched by sandwiching the inner blade edge angle 251 of the upper blade and the outer blade edge angle of the lower blade 22 in a state where tension is applied.

  FIG. 4 is a cross-sectional view showing a schematic configuration of a punching device 20B according to another embodiment of the present invention. This punching device 20B includes an inner blade edge angle 221 positioned on the product cutting surface side for cutting the outer edge of the product (gasket 10) on the lower blade 22, and an outer blade edge angle 222 positioned outside the product cutting surface side. Is included, and an angle R is given to the outer edge angle 222 of the lower blade 22.

In FIG. 4, a member indicated by reference numeral 40 that hangs down in a cylindrical shape so as to surround the cylindrical upper blade 25 from the upper blade holding portion 24 is a tension application protrusion for applying tension to the molded sheet 30. is there.
The other constituent members are the same as those shown in FIG. 2, and the same or corresponding members are denoted by the same reference numerals.

A laminate gasket 10 having a shape substantially equivalent to the shape shown in FIG. 1 was produced. As described in JP 2013-49236 A, the gasket 10 is manufactured by using a molding die composed of a female mold and a male mold and a molding sheet in which an inert film is stacked on an unvulcanized rubber sheet. Molded between molds.
The molded gasket 10 has a size applied to a syringe for 5 mL, the product diameter (diameter D1 of the circumferential surface portion 13 in FIG. 1) is 12.5 mm, and the maximum inner diameter of the fitting recess 16 is 8. It was set to 0 mm.
The manufactured gasket 10 was stoppered, and the inner diameter of the syringe confirmed to be in contact with the inner wall was D0 = 12.0 mm.

[Punching device]
Using the punching device 20 shown in FIG. 2, the product (gasket 10) connected by the molded sheet was punched into individual products (gasket 10). In the punching device 20, the angle R of the inner blade edge angle 251 (the edge angle of the punching blade on the inert film lamination surface side) of the upper blade 25 is made different in each of Comparative Examples 1 and 2 and Examples 1 and 2, and punching processing is performed. Went.
The angle R of the outer blade edge angle 251 was measured by using a laser displacement meter LJ-V7020 manufactured by Keyence Corporation, and the total number of punching blades was measured at 90 points every 90 ° with respect to one blade.

[Evaluation]
To contact the punched portion (punched burr portion 17) of the gasket 10 and the inner wall of the syringe, the tip of the pusher is attached to the fitting recess 16 of the gasket 10, the gasket 10 is manually plugged into the syringe, and the contact is made visually. confirmed.

The visual inspection was carried out at a place with a brightness of 1800 lux or more with the object 20 cm or more away from the eyes. The number of gaskets evaluated was 20 each. In all gaskets, ◯ indicates that there is no contact, △ indicates that one is in contact, and Δ indicates that two or more are in contact.
The poor suction when the gasket stoppered to the syringe, and calculate the area of the gasket bottom ratings N = 20 pieces of average values in the case of 45 mm ² or more 〇, if it is less than 45 mm ² at 40 mm ² or more △, When it was less than 45 mm ² , it was evaluated as “x”.

The film piece adhered to the product was visually inspected on the product punched from the burr. The inspection method was performed under the same conditions as those used when confirming the contact between the punched portion of the gasket and the inner wall of the syringe. Each of the evaluation numbers was N = 20, and the adhesion rate was calculated.
The results of the evaluation are as shown in Table 1.

  The present invention is not limited to the embodiments and examples described above, and various design changes can be made within the scope of the matters described in the claims. For example, in the present invention, the product to be punched is described as a gasket, but the product to be punched may be a medical rubber stopper, a rubber cap, or the like.

10 Gasket 11 Body 12 Laminate film (inert film)
13 circumferential surface portion 14 liquid contact portion 15 rear end surface 16 fitting recess 17 rear end cut surface portion (punching burr portion)
20, 20B Punching device 21 Lower blade holding portion 22 Lower blade 23 Molded sheet receiving portion 24 Upper blade holding portion 25 Upper blade 251, 221 Inner blade edge angle 252, 222 Outer blade edge angle 30 Molded sheet

Claims (7)

A punching device that includes a lower blade and an upper blade, places a product connected by a molded sheet between the lower blade and the upper blade, and punches the product from the molded sheet by sandwiching the lower blade and the upper blade. And
The lower blade or the upper blade includes an inner blade edge angle located on the product cutting surface side for cutting an outer edge of the product, and an outer blade edge angle located on the outer side of the product cutting surface side,
A punching device, wherein a corner radius is given to the outer blade tip angle.   2. The punching device according to claim 1, wherein the corner radius given to the outer blade edge angle has a radius of curvature of 0.02 mm or more.   2. The punching device according to claim 1, wherein the corner radius given to the outer blade tip angle has a curvature radius of 0.02 mm to 0.5 mm.   The product connected by the molded sheet is formed by molding a molded sheet in which an inert film is laminated on one surface of an elastic material. The punching device described in 1.   The punching device according to claim 4, wherein the product includes a gasket for a prefilled syringe in which an inert film is laminated on a wetted part. The blade provided with an angle R on the outer blade tip angle is an upper blade,
When the said upper blade descend | falls toward a lower blade, a tension | tensile_strength is provided with respect to the product connected with the shaping | molding sheet arrange | positioned on a lower blade. The punching device according to item. A gasket applied to a medical syringe including a main body made of an elastic material and an inert film laminated on the surface of the main body,
The gasket includes a circumferential surface portion that contacts an inner circumferential surface of the syringe;
Formed around the rear end of the gasket, and includes a rear end cut surface portion generated when the gasket is punched from a molded sheet,
The gasket according to claim 1, wherein the rear end cut surface portion has a peripheral diameter that does not contact the inner peripheral surface of the syringe.

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