Source: http://www.google.com/patents/US20020029022?dq=7,444,563
Timestamp: 2014-12-26 02:25:10
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Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

Patent US20020029022 - Pierceable stopper and method of producing the same - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA pierceable stopper for a liquid container, which has a pierceable part made of a thermoplastic synthetic resin elastic material. The pierceable part is formed so as to prevent leakage of liquid from the container when it is pierced with a hollow needle. The pierceable part is confined in a compressed...http://www.google.com/patents/US20020029022?utm_source=gb-gplus-sharePatent US20020029022 - Pierceable stopper and method of producing the sameAdvanced Patent SearchPublication numberUS20020029022 A1Publication typeApplicationApplication numberUS 09/859,475Publication dateMar 7, 2002Filing dateMay 18, 2001Priority dateNov 4, 1998Also published asCN1252986A, DE69921267D1, DE69921267T2, DE69921267T8, EP0999146A2, EP0999146A3, EP0999146B1, US6607685Publication number09859475, 859475, US 2002/0029022 A1, US 2002/029022 A1, US 20020029022 A1, US 20020029022A1, US 2002029022 A1, US 2002029022A1, US-A1-20020029022, US-A1-2002029022, US2002/0029022A1, US2002/029022A1, US20020029022 A1, US20020029022A1, US2002029022 A1, US2002029022A1InventorsMasanori Naritomi, Masao ShiraishiOriginal AssigneeTaisei Plas Co., Ltd.Export CitationBiBTeX, EndNote, RefManReferenced by (12), Classifications (14), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetPierceable stopper and method of producing the sameUS 20020029022 A1Abstract A pierceable stopper for a liquid container, which has a pierceable part made of a thermoplastic synthetic resin elastic material. The pierceable part is formed so as to prevent leakage of liquid from the container when it is pierced with a hollow needle. The pierceable part is confined in a compressed state in the stopper body of the pierceable stopper. A molten thermoplastic synthetic resin elastic material is injected into an injection mold at an injection pressure higher than the normal injection pressure to mold the pierceable part. Images(2) Claims(12)
DESCRIPTION OF THE PREFERRED EMBODIMENTS [0020] The present invention will be described below in detail with reference to the accompanying drawings. First Embodiment [0021]FIG. 1 shows an example in which the pierceable stopper according to the present invention is applied to a medical liquid container for intravenous drip infusion. A medical liquid container 1 for intravenous drip infusion has a container body 2 made of a film-shaped transparent synthetic resin material, e.g. polyethylene. The container body 2 contains a medical liquid. The container body 2 has an opening 3 formed at the top thereof. One end of a tubular connecting pipe 4 is inserted into the opening 3. The opening 3 and the connecting pipe 4 are welded together by ultrasonic welding or the like. A pierceable stopper 5 is fitted and connected to the upper end of the connecting pipe 4. The connecting pipe 4 and the pierceable stopper 5 are also connected by ultrasonic or other welding method. [0022] The pierceable stopper 5 comprises a stopper body 10, a pierceable part 11, an external hermetic sealing film 12, and an internal hermetic sealing film 13. The external hermetic sealing film 12 is a kind of partition for preventing the pierceable part 11 and the outside air from coming into direct contact with each other. The internal hermetic sealing film 13 is a partitioning member disposed to prevent the pierceable stopper 5 and the medical liquid in the container body 2 from coming into direct contact with each other and to maintain the airtightness of the container. The internal hermetic sealing film 13 and the container body 2 are joined together by using a publicly known technique, e.g. thermowelding using ultrasonic waves or bonding using an adhesive. [0023] The pierceable part 11 and the stopper body 10, which constitute the pierceable stopper 5, are formed by using two different kinds of synthetic resin materials. The pierceable part 11 is provided inside the stopper body 10 by an injection molding method (described later). The pierceable part 11 is positioned in the central portion of the stopper body 10. The stopper body 10 and the pierceable part 11 are integrally molded by an insert dissimilar material injection molding process (described later). [0024] The stopper body 10 is made of a thermoplastic synthetic resin material known as an engineering plastic material, e.g. polypropylene (PP), polyethylene (PE), ABS resin (ABS), polycarbonate (PC), or polyamide (PA). As a material for the pierceable part 11, various thermoplastic synthetic resin elastic materials can be used. Thermoplastic synthetic resin elastic materials usable in the present invention include nylon, polyurethane, olefin, polyester and styrene elastomers having a JIS(A) harness of 20 to 65 degrees, which is lower than the hardness of engineering plastics. One or more thermoplastic synthetic resin elastic materials are optionally selected from those mentioned above and used alone or in the form of a composite or mixed elastomer. [0025] Even when the pierceable part 11 is pierced with a hollow needle, there will be no leakage from a crack, tear or cut opening which may be made in a pierced portion thereof. When the pierceable part 11 is pierced with a hollow needle, a tear or an opening is formed therein by the wedge action of the needle. After the formation of the tear or opening, the medical liquid in the container body 2 may leak out through the tear or the opening in a state where the needle is stuck into the pierceable part 11 or has been pulled out from it. [0026] The reason for this is presumed as follows. Penetration of the needle into the pierceable part 11 causes permanent set, more precisely, permanent compression set, to be formed around the opening. Consequently, the pierceable part 11 cannot elastically recover from the deformation, or even if it recovers, the pierceable part 11 cannot ensure a sufficient elastic recovery force to close the opening. If the pierceable part 11 has a sufficient elastic recovery force, the tear or the opening can be closed by the elastic pressure. Therefore, there will be no leakage of the medical liquid from the container body 2. [0027] Accordingly, it is necessary to impart physical properties to the pierceable part 11 so that there will be no leakage of the medical liquid. Such physical properties can be given by the following production process. Method of Production by Injection Molding [0028]FIG. 2 shows a mold assembly used in the method of molding the pierceable stopper 5 according to the present invention. The mold assembly is formed from a stationary mold element 20 and a movable mold element 21. The stationary mold element 20 is provided with a gate 22 and a runner 23 communicating with the gate 22. When the stationary mold element 20 and the movable mold element 21 are in a closed position, a first cavity 25 is defined therebetween. [0029] In the first cavity 25, a previously molded stopper body 10 is inserted. Accordingly, a second cavity 26 is defined between the stationary mold element 20, the movable mold element 21 and the stopper body 10. The second cavity 26 is a space for forming the pierceable part 11. [0030] A melt of the above-described thermoplastic synthetic resin elastomer is injected into the second cavity 26. As the injection pressure of the resin melt, such a pressure is applied as causes a larger amount of volume reduction than the amount of volume reduction caused by the natural shrinkage of a melt, a semi-melt or a solid due to a temperature drop. More specifically, the resin melt is injected at a pressure higher than the normal injection pressure regarded as the optimum injection condition for the thermoplastic synthetic resin elastic material. [0031] Preferably, the resin melt is injected at an injection pressure about 1.5 times higher than the normal injection pressure. More specifically, for a styrene elastomer or an olefin elastomer, it is desirable to apply an injection pressure of 500 kg/cm2 or higher, more desirably 800 kg/cm2 or higher. Consequently, the pierceable part 11 is confined in an internal space surrounded by the inner peripheral surface of the stopper body 10 and an annular projection 14 on the inner periphery of the lower portion of the stopper body 10. Accordingly, the pierceable part 11 is constantly compressed by the stopper body 10 at the outer periphery thereof and thus has an internal stress. [0032] The stopper body 10 and the pierceable part 11 are thermowelded together in the injection mold by melting the surface of the thermoplastic synthetic resin material of the stopper body 10 with the melt heat of the molten thermoplastic synthetic resin elastic material for forming the pierceable part 11. When the pierceable part 11 is pierced with a hollow needle, even if this part is cut open, the opening is closed by an elastic recovery force derived from the compressive internal stress. Therefore, there is no possibility of leakage of the liquid from the container. In addition, the thermowelded portion prevents leakage of liquid even more effectively. Second Embodiment [0033] According to the above-described first embodiment of the present invention, after the previously molded stopper body 10 has been inserted into the injection mold, the pierceable part 11 is injection-molded. In the second embodiment, the pierceable part 11 is molded previously, and after the previously molded pierceable part 11 has been inserted into an injection mold (not shown), a molten thermoplastic synthetic resin material for forming the stopper body 10 is injected to mold the stopper body 10. [0034] The molten thermoplastic synthetic resin material forms the stopper body 10 while pressurizing the pierceable part 11 from the outer periphery thereof. In other words, the stopper body 10 is molded with the pierceable part 11 compressed therein. The injection pressure of the thermoplastic synthetic resin material may be substantially equal to the above-described injection molding pressure for the pierceable part 11. However, when the viscosity of the thermoplastic synthetic resin material is high, the injection molding pressure is set at a slightly higher level. [0035] Meanwhile, the stopper body 10 and the pierceable part 11 are thermowelded together in the injection mold by melting the surface of the thermoplastic synthetic resin elastic material of the pierceable part 11 with the melt heat of the molten thermoplastic synthetic resin material for forming the stopper body 10. When the pierceable part 11 is pierced with a hollow needle, even if this part is cut open, the opening is closed by an elastic recovery force derived from the compressive internal stress. Therefore, there is no possibility of leakage of the liquid from the container. In addition, the thermowelded portion prevents leakage of liquid even more effectively. Other Embodiments [0036] In the above-described embodiments, the pierceable stopper is formed by insert molding process. However, the molding process is not necessarily limited to the insert molding process. The pierceable stopper may also be formed by two-color injection molding process in which two resin materials are injected into the same injection mold. Containers to which the present invention is applicable are not necessarily limited to those of the type wherein the liquid in the container is taken out, but the present invention is also applicable to containers of the type wherein a solution is externally injected thereinto through a hollow needle. EXAMPLES [0037] Pierceable stoppers were molded according to the above-described embodiment under the following molding conditions using a styrene elastomer [RABALON (registered trademark) MJ4300C, hardness 45 (JIS-A), manufactured by Mitsubishi Chemical Corporation] to form the pierceable part 11. Injection Molding Conditions [0038] Cylinder middle temperature: 200� C. [0039] Resin temperature: 210� C. [0040] Injection pressure: 450, 500, and 800 kg/cm2 [0041] Injection time: 3 sec. [0042] Mold temperature: 50� C. [0043] Nozzle temperature: 190� C. [0044] Table 1 below shows the results of a liquid leakage test carried out as an experimental example. In the test, each pierceable stopper was pierced with a plastic needle for intravenous drip infusion having a diameter of 4 millimeters, and left to stand for 30 minutes under ordinary temperature conditions. Then, the condition of leakage after the removal of the needle was visually judged. The diameter of the pierceable part was 14 millimeters. In Table 1, thickness is the height of the pierceable part. The material of the stopper body was polypropylene (PP). TABLE 1 Liquid Leakage Test Material Injection Test of Thickness pressure results stopper body (mm) (kgf/cm2) (n = 3) PP 1 450 x x x 500 Δ Δ Δ 800 ⊚ Δ Δ 3 450 x x Δ 500 ⊚ Δ Δ 800 ⊚ ⊚ ⊚ 6 450 Δ Δ Δ 500 Δ ⊚ Δ 800 ⊚ ⊚ ⊚ 8 450 Δ Δ Δ 500 Δ ⊚ ⊚ 800 ⊚ ⊚ ⊚ 10 450 ⊚ ⊚ Δ 500 ⊚ ⊚ ⊚ 800 ⊚ ⊚ ⊚ None 3 450 x x x 500 x x x 800 x x x 6 450 x x x 500 x x x 800 x x x [0045] The results of a liquid leakage test regarding the hardness of the pierceable part will be shown below. As the material for the pierceable part, the following three different styrene elastomers were used: RABALON (registered trademark; Mitsubishi Chemical Corporation) MJ4300C, hardness 45 (JIS-A); MJ6300C, hardness 65 (JIS-A); and MJ8300C, hardness 85 (JIS-A). The other injection molding conditions were the same as the above. TABLE 2 Liquid Leakage Test Hardness of Injection Test pierceable Thickness pressure results part (mm) (kgf/cm2) (n = 3) MJ4300C 3 500 ⊚ x x 45 (JIS-A) 800 ⊚ ⊚ ⊚ 6 500 Δ ⊚ Δ 800 ⊚ ⊚ ⊚ MJ6300C 3 500 ⊚ Δ Δ 65 (JIS-A) 800 ⊚ ⊚ ⊚ 6 500 ⊚ ⊚ Δ 800 ⊚ ⊚ ⊚ MJ8300C 3 500 x x x 85 (JIS-A) 800 x x x 6 500 x x x 800 x x x [0046] In the pierceable stopper according to the present invention, even if the pierceable part, which is pierceable with a hollow needle, is formed by using a thermoplastic synthetic resin elastomer inferior in elastic recovery force to rubber, there is no leakage of liquid from the container when the pierceable part is pierced with a hollow needle or after the needle has been pulled out. [0047] It should be noted that the present invention is not necessarily limited to the foregoing embodiments but can be modified in a variety of ways without departing from the gist of the present invention. Referenced byCiting PatentFiling datePublication dateApplicantTitleUS6929040Jun 19, 2003Aug 16, 2005Medical Instill Technologies, Inc.Sterile filling machine having needle filling station within e-beam chamberUS7032631Jan 28, 2004Apr 25, 2006Medical Instill Technologies, Inc.Medicament vial having a heat-sealable cap, and apparatus and method for filling the vialUS7100646Sep 3, 2003Sep 5, 2006Medical Instill Technologies, Inc.Sealed containers and methods of making and filling sameUS7111649Apr 11, 2005Sep 26, 2006Medical Instill Technologies, Inc.Sterile filling machine having needle filling station within e-beam chamberUS7243689Apr 21, 2006Jul 17, 2007Medical Instill Technologies, Inc.Device with needle penetrable and laser resealable portion and related methodUS7445033Jul 16, 2007Nov 4, 2008Medical Instill Technologies, Inc.Device with needle penetrable and laser resealable portion and related methodUS7490639Dec 3, 2007Feb 17, 2009Medical Instill Technologies, Inc.Device with needle penetrable and laser resealable portion and related methodUS7500498Oct 31, 2007Mar 10, 2009Medical Instill Technologies, Inc.Device with needle penetrable and laser resealable portion and related methodUS7556066Sep 25, 2006Jul 7, 2009Medical Instill Technologies, Inc.Sterile filling machine having needle filling station and conveyorUS7905257Jul 2, 2009Mar 15, 2011Daniel PySterile filling machine having needle filling station and conveyorUS8448674Mar 11, 2011May 28, 2013Medical Instill Technologies, Inc.Sterile filling machine having filling station and E-beam chamberUS20090107947 *Oct 23, 2008Apr 30, 2009Knaack Jesse AProtective device* Cited by examinerClassifications U.S. Classification604/256, 264/512International ClassificationB29L31/56, B29C45/14, B29K19/00, A61J1/05, B29K9/06, B29C45/16, B65D51/00Cooperative ClassificationB29C45/1676, B65D51/002, B29L2031/56European ClassificationB29C45/16L, B65D51/00BLegal EventsDateCodeEventDescriptionJan 21, 2011FPAYFee paymentYear of fee payment: 8Jan 26, 2007FPAYFee paymentYear of fee payment: 4RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google