Source: http://www.google.com/patents/US4915243?dq=7,292,151
Timestamp: 2017-11-20 21:29:20
Document Index: 627958461

Matched Legal Cases: ['Application No. 116191', 'art 7', 'art 11', 'art 3', 'art 16', 'art 14', 'art 3', 'art 4', 'art 11', 'art 12']

Patent US4915243 - Resin-laminated rubber closure for a medical vial - Google Patents
A resin-laminated rubber closure for a medical vial is provided herein. This closure comprises an annular leg part to be inserted into the mouth of the vial, which leg part is notched or cut at least at one position and a flange part to be contacted with the front surface of the vial mouth, wherein the...http://www.google.com/patents/US4915243?utm_source=gb-gplus-sharePatent US4915243 - Resin-laminated rubber closure for a medical vial
Publication number US4915243 A
Application number US 07/185,363
Also published as DE3674949D1, EP0204486A2, EP0204486A3, EP0204486B1, US5078941
Publication number 07185363, 185363, US 4915243 A, US 4915243A, US-A-4915243, US4915243 A, US4915243A
Inventors Yutaka Tatsumi, Hideo Yoshitaka, Tatsuya Matsunaga, Denpei Sudo, Tamotsu Okuda
Original Assignee Daikyo Gomu Seiko, Ltd., Yamanouchi Pharmaceutical Co., Ltd.
Patent Citations (11), Referenced by (33), Classifications (16), Legal Events (3)
Resin-laminated rubber closure for a medical vial
US 4915243 A
A resin-laminated rubber closure for a medical vial is provided herein. This closure comprises an annular leg part to be inserted into the mouth of the vial, which leg part is notched or cut at least at one position and a flange part to be contacted with the front surface of the vial mouth, wherein the outer and inner surfaces of the annular leg part is provided with a chemical-resistant resin film laminated thereon except for the upper end of the leg part so that the rubber surface is exposed at the upper end of said leg portion, and wherein the leg part has at least one protrusion on the outer surface of the laminated portion. The present invention also relates to a molding process for economically producing said closure.
1. A resin-laminated rubber closure for a medical vial comprising an annular leg part to be inserted into the mouth of the vial, the leg part being notched at least at one position, and a flange part to be contacted with the front surface of the vial mouth, in which the outer and inner surfaces of the annular leg part are laminated with a chemical-resistant resin film except for the outer circumference of the upper end of the leg part to expose a rubber surface at this upper end leg part and to form an upper edge of the laminated portion and the leg part has a central ceiling part inside and one or more protrusions on the outer surface of the laminated portion, wherein the rubber surface above the upper edge of the laminated portion has a length (x) of 0.1 to 5 mm and wherein the height (m) of the central ceiling part inside the annular leg part from the upper edge of the laminated portion is in the range of 0.1 to 5 mm said chemical-resistant resin film being of a material selected from the group consisting of tetrafluoroethylene polymers, trifluorochloroethylene polymers, tetrafluoro-ethylene-hexafluoropropylene copolymers, vinylidene fluoride polymers, vinyl fluoride polymers, tetrafluoroethylene-ethylene copolymers and trifluorochloroethylene-ethylene copolymers and the central ceiling part inside the annular leg part having a height greater than that of the upper edge of the laminated portion.
2. The resin-laminated rubber closure of claim 1, wherein the protrusion has a height of 0.1 to 1.0 mm.
3. The resin-laminated rubber closure of claim 1, wherein the chemical-resistant resin film has a thickness of 0.002 to 5 mm.
This application is a continuation of now abandoned application Ser. No. 867,677, filed May 28, 1986.
Lately, in order to improve the quality of a medical drug such as cephalosporin, it has been required to maintain the vial airtight for a longer period of time than in the prior art. The inventors have conducted studies to meet with this requirement and thus have proposed a resin-laminated rubber closure A as shown in FIG. 4 in which the outer circumference of the upper end 2 of the annular leg part is not laminated to expose the rubber surface (Japanese Utility Model Application No. 116191/1984). Production of this rubber closure can be carried out by the above described processed proposed by applicant, in which the flange part 7 of the base body is cut so as to retain no burr in the first step, but the production efficiency is very low.
It is an object of the present invention to provide a process for the production of a rubber closure or plug for a medical vial, whereby the above described drawbacks of the prior art can be overcome.
FIGS. 3(a") to 3(f") are schematic views illustrating the steps for producing rubber closures for vials according to the prior art.
The inventors have made various studies on the cutting operation in the above described known process for the production of a laminated rubber closure and consequently, have found that the depth of an annular hollow of a lower metal mold in the second step is made deeper than that of a lower metal mold in the first step and a non-laminated rubber plate is applied to the upper part of a primary molded article, followed by hot pressing, vulcanizing and integrating them, whereby to form an exposed rubber surface at the upper end of the leg part more effectively than in the known process. Furthermore, if the top of a primary molded article is of a truncated cone, the height of the central ceiling part inside an annular leg part can readily be higher to make a needle-piercing part thinner without hollowing the upper surface of the flange part of the rubber closure, and the upper part of the leg part and the flange part, molded over the primary molded article can strongly be bonded and integrated with the primary molded article.
According to the process of the present invention, a resin-laminated rubber closure capable of maintaing a higher degree of airtightness for a longer period of time is provided herein while a medical vial is half closed by the rubber closure while subjecting a medical drug solution to freeze drying. The vial is then completely closed and secured by an aluminum sealing cap. The closure can be effectively mass-produced, since the annular hollow part 11 of a second metal mold is made deeper than the annular hollow part 3 of a first metal mold and the non-laminated upper part 16 of a leg part and the flange part 14 are formed on and integrated with the upper part of the primary molded article 7 as shown in FIG. 1.
Referring to FIG. 1 and FIG. 2, preferred embodiments of the present invention will now be illustrated. A first metal mold 2 for forming a leg part has an annular hollow part 3 of W-type corresponding to the profile of the leg part, as shown in (a) and (a'). The height of the central top P of the annular hollow part of W-type is higher than that of the outer circumference of the annular hollow part (FIG. 1(a)) or substantially similar thereto (FIG. 2(a')). When the top part is made higher, the thickness of rubber of the ceiling part is thinner and an injection needle can readily be pierced when using an injection liquid. A first metal mold 1 for forming an upper part has a hollow part 4 of truncated cone type (FIG. 1(a)) or is plate-shaped (FIG. 2 (a)). A non-vulcanized compound rubber plate on one surface of which is laminated a surface-treated fluoro-resin film is arranged between both the metal molds, pressed, heated and thus vulcanized, thus obtaining a primary molded article 7 or 6 whose leg part is completely laminated with the fluoro-resin film and whose upper part is of a truncated cone form or of a plate form, not laminated. The pressing and heating conditions in this step, depending upon the quality of a fluoro-resin laminated plate employed, the variety of a compound rubber, compounding agents, the thickness of the laminated plate, etc., are preferably 150° to 175° C. and 40 to 70 kg/cm2 for about 10 minutes, for example, 160° to 165° C. and about 50 kg/cm2 for about 15 minutes in the case of using a tetrafluoroethylene-ethylene copolymer film and a compound rubber containing 58% of butyl rubber.
The primary molded article is taken out of the metal mold and then subjected to a punching operation to remove a burr 8 or 7 at the circumference, thus obtaining a primary molded article as shown in (c) or (c'). The thus obtained primary molded article 7 or 6 is charged in a second metal mold 10 or 9 having an annular hollow part 11 or 10 of W-type, in cross section, and corresponding to the form of the leg part, the hollow part being deeper than that of the first metal mold 2, as shown in (d) or (d'). A non-vulcanized compound rubber plate 13 or 11 is placed thereon and then subjected to hot pressing and vulcanizing by the use of another metal mold 9 or 8 having a hollow part 12 corresponding to the shape of the upper part. This vulcanization step is carried out at a temperature of 160° to 175° C. for about 8 minutes. During the same time, the primary molded article and upper rubber plate are integrated and bonded strongly. When the central ceiling part inside the annular leg part is higher than usual, the thickness of the upper part can be made so thin that when using the resulting rubber closure for a medical vial, piercing of an injection needle can more readily be effected. Then, the secondary molded article is taken out of the second metal mold and subjected to removal of the circumferential burr 15 or 13, thus obtaining a finished product shown as (f) or (f').
In the present invention, the outer shape or profile of a leg part of a resin-laminated rubber closure can be suitably varied from a simple form as shown in FIG. 1(f) to a complex form wherein a level difference 2 and projection or protrusion 3 are provided between the upper end and lower end of the leg part as shown in FIG. 4 by changing the first metal mold or second metal mold.
According to the process for the production of a resin-laminated rubber closure according to the present invention, a rubber closure member with a special form suitable for a medical or pharmaceutical product can be economically produced. For example, fluoro-resin laminated rubber closures having special forms can effectively be produced such as having an exposed rubber surface at the upper end of a leg part so as to improve the adaptability as well as airtightness to the mouth of a vial, having a leg part whose upper end portion is enlarged in size, and having a leg part provided with a projection or protrusion on the outside thereof and having a central upper part with a reduced thickness for piercing an injection needle.
As freeze drying has recently been carried out in a large-sized vessel and operations of automation have accordingly increased, the requirements for stabilization of the half closed state have become severer. When the rubber closure is controlled only in respect to the vertical position by the protrusion 4, a lateral movement or rolling phenomenon often occurs to incline or cause the rubber closure to slip off. In order to prevent this phenomenon, another protrusion 7 should preferably be provided below the protrusion 4, thereby increasing the stability of the rubber closure when the vial is half closed. 5 represents a convex part for fastening the surface of the rubber closure and 6 represents a hollow part through which an injection needle is to be pierced. The main body of the rubber closure is made thinner at this position for the ease of piercing an injection needle.
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U.S. Classification 215/247, 215/364
International Classification B29C43/14, B29C43/18
Cooperative Classification B29C43/18, B29C2043/148, B29C43/146, B29C43/203, B29K2021/00, B29K2027/12, B65D51/241, B29L2031/565
European Classification B29C43/20B, B29C43/18, B29C43/14C, B65D51/24A