Source: http://www.google.com/patents/US20070066941?ie=ISO-8859-1&dq=4182933
Timestamp: 2015-05-05 08:18:34
Document Index: 201494264

Matched Legal Cases: ['art. 2', 'art 11', 'art 12', 'art 11', 'art 11', 'art 11', 'art 21', 'arts 31', 'art 32', 'arts 31', 'arts 31', 'arts 31', 'art 32', 'art 41', 'art 42', 'art 41', 'art 42', 'art 46', 'art 46', 'art 46', 'art 11', 'art 11', 'art 21', 'art 21']

Patent US20070066941 - Sealing body, cap with the sealing body, and medical container - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsAn inventive sealing body is a generally disk-like sealing body composed of two or more types of thermoplastic elastomers having different hardnesses, and comprises at least a needle stick part extended in axial direction and an outer edge part surrounding the needle stick part. The outer edge part has...http://www.google.com/patents/US20070066941?utm_source=gb-gplus-sharePatent US20070066941 - Sealing body, cap with the sealing body, and medical containerAdvanced Patent SearchPublication numberUS20070066941 A1Publication typeApplicationApplication numberUS 10/557,842PCT numberPCT/JP2004/006988Publication dateMar 22, 2007Filing dateMay 17, 2004Priority dateMay 22, 2003Also published asCA2525053A1, CN1795026A, EP1625873A1, WO2004103453A1Publication number10557842, 557842, PCT/2004/6988, PCT/JP/2004/006988, PCT/JP/2004/06988, PCT/JP/4/006988, PCT/JP/4/06988, PCT/JP2004/006988, PCT/JP2004/06988, PCT/JP2004006988, PCT/JP200406988, PCT/JP4/006988, PCT/JP4/06988, PCT/JP4006988, PCT/JP406988, US 2007/0066941 A1, US 2007/066941 A1, US 20070066941 A1, US 20070066941A1, US 2007066941 A1, US 2007066941A1, US-A1-20070066941, US-A1-2007066941, US2007/0066941A1, US2007/066941A1, US20070066941 A1, US20070066941A1, US2007066941 A1, US2007066941A1InventorsKenji Tezuka, Hiroshi Honda, Junji Kaga, Minoru Oka, Hidekatsu ShojiOriginal AssigneeKenji Tezuka, Hiroshi Honda, Junji Kaga, Minoru Oka, Hidekatsu ShojiExport CitationBiBTeX, EndNote, RefManReferenced by (1), Classifications (14), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetSealing body, cap with the sealing body, and medical container
US 20070066941 A1Abstract
An inventive sealing body is a generally disk-like sealing body composed of two or more types of thermoplastic elastomers having different hardnesses, and comprises at least a needle stick part extended in axial direction and an outer edge part surrounding the needle stick part. The outer edge part has a higher hardness than that of the needle stick part. More specifically, a difference in JIS-A hardness between the outer edge part and the needle stick part, for example, is 5 to 15. The sealing body is tightly fitted in a generally cylindrical outer frame body composed of a rigid plastic to provide a cap. The cap is welded to a mouth part of a plastic container or the mouth part is tightly sealed with the sealing body to provide a medical container. Images(6) Claims(9)
1. A sealing body having a generally disk-like shape formed of two or more types of thermoplastic elastomers with different hardnesses, the sealing body comprising at least a needle stick part extended in axial direction and an outer edge part surrounding the needle stick part, the outer edge part having a higher hardness than that of the needle stick part. 2. A sealing body as set forth in claim 1, wherein the outer edge part has a JIS A hardness of 25 to 80, and the needle stick part has a JIS A hardness of 5 to 30. 3. A sealing body as set forth in claim 1, wherein a difference in JIS A hardness between the outer edge part and the needle stick part is 5 to 15. 4. A sealing body as set forth in claim 1, wherein the needle stick part is provided in a center portion of the sealing body and has a cylindrical shape, and the needle stick part has a diameter which is 40 to 70% of a diameter of the entire sealing body. 5. A sealing body as set forth in claim 1, wherein the needle stick part includes two to five needle stick parts. 6. A sealing body as set forth in claim 1, having a thickness of 3 to 10 mm and a diameter of 10 to 40 mm. 7. A cap comprising a sealing body having a generally disk-like shape formed of two or more types of thermoplastic elastomers with different hardnesses, the sealing body comprising at least a needle stick part extended in axial direction and an outer edge part surrounding the needle stick part and having a higher hardness than that of the needle stick part, wherein the sealing body is tightly fitted in an outer frame body having a generally cylindrical shape formed of a rigid plastic. 8. A medical container made of plastic comprising a cap which is welded to a mouth part of the medical container, the cap comprising a sealing body having a generally disk-like shape formed of two or more types of thermoplastic elastomers with different hardnesses, the sealing body comprising at least a needle stick part extended in axial direction and an outer edge part surrounding the needle stick part and having a higher hardness than that of the needle stick part, wherein the sealing body is tightly fitted in an outer frame body having a generally cylindrical shape formed of a rigid plastic. 9. A medical container comprising a mouth part, wherein the mouth part is tightly sealed by a sealing body having a generally disk-like shape formed of two or more types of thermoplastic elastomers with different hardnesses, the sealing body comprising at least a needle stick part extended in axial direction and an outer edge part surrounding the needle stick part and having a higher hardness than that of the needle stick part. Description
BEST MODE FOR IMPLEMENTING THE INVENTION The sealing body, the cap and the medical container according to the present invention will hereinafter be described in detail with reference to the attached drawings. First Embodiment A sealing body 10 shown in FIG. 1 is an exemplary sealing body according to one embodiment of the present invention. The sealing body 10 has a disk shape, and includes a cylindrical needle stick part 11 extending in an axial direction x and an outer edge part 12 surrounding the needle stick part 11. In the sealing body 10 shown in FIG. 1, a single needle stick part 11 is provided in a center portion of the sealing body 10. In this case, the diameter D2 of the needle stick part 11 is preferably 40 to 70% of the diameter D1 of the entire sealing body 10. A cap 15 shown in FIG. 2 and an infusion bottle 20 shown in FIG. 3 are an exemplary cap and medical container according to the embodiment of the present invention. The cap 15 shown in FIG. 2 includes the sealing body 10 shown in FIG. 1, a generally cylindrical outer frame body 16 of a rigid plastic, and a generally cylindrical inner frame body 18. The sealing body 10 is inserted in a cylindrical portion of the outer frame body 16 from the side of a bottom 15 b thereby to be fitted in the outer frame body 16 with no gap formed between an inner peripheral surface of the outer frame body 16 and an outer peripheral surface 10 c of the sealing body 10. The sealing body 10 is fixed in the cylindrical portion of the outer frame body 16 by inserting the inner frame body 18 in the outer frame body 16 from the side of the bottom 15 b. Projections 13 a, 13 b respectively provided on a top surface 10 a and a bottom surface 10 b of the sealing body 10 and a groove 13 c provided in the top surface 10 a of the sealing body 10 are engaged with the outer frame body 16 and the inner frame body 18, whereby the sealing body is more assuredly fixed to the cylindrical portion of the outer frame body 16. The cap 15 shown in FIG. 2 includes a cover 17 of a pull-off (pull-top) type. By pulling up a ring 17 a, the cover 17 is pulled off. The cover 17 protects the top surface 10 a of the sealing body from dust until the cap 15 is actually used. The infusion bottle 20 shown in FIG. 3 is such that the cap 15 shown in FIG. 2 is welded to a mouth part 21 of a plastic medical container (medical container body 22). Second Embodiment A sealing body 30 shown in FIG. 4 is an exemplary sealing body according to another embodiment of the present invention. Like the sealing body 10 shown in FIG. 1, the sealing body 30 has a disk shape. The sealing body 30 includes three cylindrical needle stick parts 31 each extending in an axial direction x, and an outer edge part 32 surrounding all the needle stick parts 31 a to 31 c. In the sealing body 30 shown in FIG. 4, the ratio of the diameter of each of the needle stick parts 31 to the diameter of the entire sealing body 30 is not particularly limited, but may be properly determined depending on the hardnesses of the needle stick parts 31 and the outer edge part 32 for simultaneously ensuring a sufficient sealability during the sticking as well as a sufficient sticking member holding capability and easier handling during the sticking. In FIG. 4, components other than those described above are denoted by the same reference characters as in FIG. 1. Third Embodiment A sealing body 40 shown in FIG. 5 is an exemplary sealing body according to further another embodiment of the present invention. The sealing body 40 includes a cylindrical needle stick part 41 extending in an axial direction x, and an outer edge part 42 surrounding the needle stick part 41. The outer edge part 42 includes a flange 42 a provided on an outer peripheral surface 40 a of the sealing body 40 for engagement with a mouth part edge of a medical container. The sealing body 40 shown in FIG. 5 is used for tightly sealing a mouth part 46 of a vial 45 as shown in FIG. 6. The outer shape of the sealing body 40 is properly determined so that no gap is formed between the outer peripheral surface 40 a and the mouth part 46 of the vial 45. To firmly fix the sealing body 40 to the vial 45, a clamping member 48 may be provided around the mouth part 46 and the outer edge part of the sealing body 45. Sealing Body An essential requirement for the inventive sealing body is that the hardness of the needle stick part is lower than the hardness of the outer edge part. In addition, the needle stick part per se preferably has a JIS A hardness of 5 to 30. If the JIS A hardness of the needle stick part (the hardness of the thermoplastic elastomer for the needle stick part) is lower than 5, it is impossible to ensure a sufficient sticking member holding capability and easier handling during the sticking. Further, the needle stick part has a reduced mechanical strength and, therefore, is more liable to be broken. On the other hand, if the JIS A hardness of the needle stick part (the hardness of the thermoplastic elastomer for the needle stick part) is higher than 30, the ease of the sticking with the sticking member is lessened (the sticking with the sticking member is more difficult) and the sealability during the sticking is deteriorated. Particularly, the JIS A hardness of the needle stick part is preferably not lower than 15 and lower than 30, more preferably not lower than 18 and not higher than 25, in the aforesaid hardness range. Another essential requirement for the inventive sealing body is that the outer edge part has a higher hardness than the needle stick part. In addition, the outer edge part per se preferably has a JIS A hardness of 25 to 80. If the JIS A hardness of the outer edge part (the hardness of the thermoplastic elastomer for the outer edge part) is lower than 25, it may be impossible to ensure a sufficient sticking member holding capability and easier handling during the sticking. On the other hand, if the JIS A hardness of the outer edge part (the hardness of the thermoplastic elastomer for the outer edge part) is higher than 80, the welding between the outer edge part and the needle stick part is difficult, and the adhesion between the outer frame body and the inner frame body is reduced. Particularly, the JIS A hardness of the outer edge part is preferably 30 to 45 in the aforesaid hardness range. In the inventive sealing body, a difference in JIS A hardness between the needle stick part and the outer edge part is not particularly limited, but is preferably about 5 to about 15. In the inventive sealing body, the thermoplastic elastomers for the needle stick part and the outer edge part are merely required to be weldable to each other, but the other requirements for these thermoplastic elastomers are not particularly limited. For improvement of the weldability, thermoplastic elastomers of the same type are preferably used. Examples of the thermoplastic elastomers usable in the present invention include conventionally known various thermoplastic elastomers including styrene elastomers such as a styrene-ethylene/butylene-styrene block copolymer (SEBS), a styrene-butadiene-styrene block copolymer (SBS), a styrene-isoprene-styrene block copolymer (SIS), a SEBS modified with maleic acid or the like, a styrene-ethylene/propylene-styrene block copolymer (SEPS), a styrene-ethylene/butylene block copolymer (SEB) and a styrene-ethylene/propylene block copolymer (SEP), olefin elastomers such as an ethylene-propylene block copolymer, and polyurethane elastomers. As the material for the inventive sealing body, any of the aforesaid thermoplastic elastomers may be used alone or mixed with a thermoplastic resin. Examples of the thermoplastic resin to be mixed with the thermoplastic elastomer include polyethylene and polypropylene. The hardness of the thermoplastic elastomer to be used in the present invention is adjusted by properly determining the amount of an additive such as an oil to be added or by properly determining the type and amount of the thermoplastic resin to be mixed. Cap As described above, the inventive cap is produced by fitting the inventive sealing body in a generally cylindrical outer frame body of a rigid plastic. Outer Frame Body Examples of the rigid plastic for the outer frame body include various plastics including polyolefins such as polyethylene, polypropylene and poly-4-methylpentene (e.g., available under the trade name of TPX from Mitsui Chemicals Inc.), polycycloolefins such as ethylene-tetracyclododecene copolymer (e.g., available under the registered trademark of APEL from Mitsui Chemicals Inc.), an acrylonitrile-butadiene-styrene copolymer (ABS), polyesters such as polyethylene naphthalate (PEN), polyethylene terephthalate (PET) and polyarylate, and benzene series polymers such as polyphenylene sulfide (PPS), which are conventionally used for medical instruments. Among the aforesaid exemplary rigid plastics for the outer frame body, rigid plastics which are highly compatible to and weldable with a plastic to be used as a material for the mouth part of the medical container are particularly preferred. Inner Frame Body The inventive cap may include a generally cylindrical inner frame body provided in a cylindrical portion of the outer frame body to fix the sealing body in the cylindrical portion of the outer frame body. A material for the inner frame body is not particularly limited, but any of the aforesaid rigid plastics to be used as the material for the outer frame body is preferably used as the material for the inner frame body. Medical Container As described above, the inventive medical container may be: (I) a medical container made of plastic including the inventive cap which is welded to a mouth part of the medical container; or (II) a medical container including the inventive sealing body which tightly seals a mouth part of the medical container. A method for welding the inventive cap to the mouth part of the medical container (I) is not particularly limited, but a conventionally known welding method may be employed. For example, the rigid plastic outer frame body of the cap is welded to the mouth part of the plastic medical container by heat welding or high-frequency welding. The medical container (I) may be provided in a so-called kit form, in which a cylindrical holder having a double ended needle is fixed to the outer frame body of the cap welded to the mouth part of the medical container. A clamping member to be used for fixing the sealing body to the mouth part of the medical container (II) (e.g., a vial) is not particularly limited, but a conventionally known metal thin film may be used as a material for the clamping member. EXAMPLES The sealing body, the cap and the medical container according to the present invention will hereinafter be described by way of examples thereof. Production of sealing body, cap and infusion bottle Example 1 (1) Production of Sealing Body A sealing body 10 as shown in FIG. 1 was injection-molded from the following compositions A and B. Composition A prepared by blending a thermoplastic styrene elastomer, a paraffin process oil and polypropylene in a weight ratio of 100:100:20 and having a JIS A hardness of 35 Composition B prepared by blending a thermoplastic elastomer, a paraffin process oil and polypropylene in a weight ratio of 100:200:20 and having a JIS A hardness of 20 For the compositions A and B, a block copolymer (available under the registered trademark of Tuftec H1272 from Asahi Kasei Corp. and having a number average molecular weight (Mn) of 140,000) having a polystyrene-hydrogenated polybutadiene-polystyrene structure was used as the thermoplastic styrene elastomer. A process oil available under the product number of PW-380 from Idemitsu Kosan Co., Ltd. was used as the paraffin process oil. A polypropylene (available under the product number of J430 from Mitsui Chemicals Inc.) having a low molecular weight was used as the polypropylene. The sealing body 10 was of a disk shape as shown in FIG. 1, and had a diameter D1 of 23 mm. A needle stick part 11 of the sealing body had a diameter D2 of 12 mm. The ratio of the diameter D2 of the needle stick part 11 to the diameter D1 of the sealing body 10 was about 52%. The sealing body 10 had a thickness of 5 mm. (2) Production of Cap The aforesaid sealing body 10 was inserted into a cylindrical portion of a cylindrical polyethylene outer frame body 16 from the side of a bottom 15 b. An inner frame body 18 is inserted into the outer frame body 16 from the side of the bottom 15 b, and a projection provided on an outer peripheral surface of the inner frame body 18 was engaged with a groove formed in the cylindrical portion of the outer frame body 16 to fix the inner frame body to the outer frame body (via an engagement portion 19). Thus, a cap 15 as shown in FIG. 2 was provided. (3) Production of Infusion Bottle The bottom 15 b of the cap 15 was heat welded to a mouth part 21 of an infusion bottle body 22 of polyethylene. Thus, an infusion bottle 29 as shown in FIG. 3 was provided. Distilled water (100 mL) was preliminarily filled in the infusion bottle body 22. Comparative Example 1 (1) Production of Sealing Body A sealing body was produced in substantially the same manner as the sealing body 10 of Example 1, except that only the composition A was used. The sealing body thus produced had no distinction between a needle stick part and an outer edge part thereof, and had the same outer shape as the sealing body 10 of Example 1. (2) Production of Cap The aforesaid sealing body was inserted into a cylindrical portion of a polyethylene outer frame body 16 having the same construction as in Example 1 and fixed to the outer frame body. Thus, a cap was provided. This cap had substantially the same construction as the cap 15 of Example 1 shown in FIG. 2, except that the sealing body was different. (3) Production of Infusion Bottle The bottom of the cap was heat welded to a mouth part 21 of a polyethylene infusion bottle body 22 having the same construction as in Example 1. Thus, an infusion bottle was provided. The infusion bottle had substantially the same construction as the infusion bottle of Example 1 shown in FIG. 3, except that the sealing body of the cap was different. Comparative Example 2 A sealing body was produced in substantially the same manner as the sealing body 10 of Example 1, except that only the composition B was used. The sealing body thus produced had no distinction between a needle stick part and an outer edge part thereof, and had the same outer shape as the sealing body 10 of Example 1. An attempt was made to sequentially produce caps by supplying such sealing bodies to a cap production line. However, the sealing bodies adhered to each other to be jammed up in the line. Reference Example Two types of generally disk-like members each having a thickness of about 2.5 mm and a diameter of 23 mm were respectively injection-molded from the aforesaid compositions A and B, and then bonded to each other. Thus, a sealing body of a layer structure having the same outer shape as the sealing body 10 shown in FIG. 1 was provided. An attempt was made to sequentially produce caps by supplying such sealing bodies to a cap production line. However, the sealing bodies adhered to each other to be jammed up in the line. Test The infusion bottles produced in Example 1 and Comparative Example 1 were autoclaved at 104� C. for 60 minutes. The needle stick part of each of the autoclaved infusion bottles (the sealing body in Comparative Examples and Reference Example) was stuck with a plastic hollow needle having a diameter of about 4 mm, and then the plastic hollow needle was withdrawn. In turn, the sticking trace was penetrated again by a 16G metal hollow needle, and air was injected into the infusion bottle through the hollow needle to increase the internal pressure of the infusion bottle. At this time, the sealing body was checked for liquid leakage. After the internal pressure of the infusion bottle reached 0.06 MPa, the pressure was maintained at this level for 30 seconds, and then the sealing body was checked for liquid leakage. As a result, the infusion bottle of Example 1 was free from the liquid leakage when the internal pressure was increased and after the pressure was maintained at the increased level. On the other hand, 10 out of 300 infusion bottles of Comparative Example 1 thus tested suffered from liquid leakage before the internal pressure reached 0.04 MPa. While the present invention has thus been described by way of the embodiments thereof, these embodiments are merely illustrative, but not limitative of the invention. Variations of the present invention apparent to those skilled in the art are to fall within the scope of the present invention defined by the appended claims. INDUSTRIAL APPLICABILITY As described above, the sealing body, and the cap and the medical container each having the sealing body according to the present invention simultaneously ensure easier sticking with a sticking member and a sufficient sealability during the sticking as well as a sufficient sticking member holding capability and easier handling during the sticking, and are advantageously put in practical use in the field of medical containers such as an infusion bottle, an infusion bag and a vial. Referenced byCiting PatentFiling datePublication dateApplicantTitleUS7901446 *Jun 2, 2006Mar 8, 2011Vascutek LimitedThin-walled vascular graft* Cited by examinerClassifications U.S. Classification604/167.01International ClassificationA61M5/178, A61J1/00, A61M39/02, B65D51/00, A61M39/20, A61J1/14Cooperative ClassificationA61J1/1406, B65D51/002, A61M39/20, A61M39/02European ClassificationB65D51/00B, A61J1/14B, A61M39/02Legal EventsDateCodeEventDescriptionNov 21, 2005ASAssignmentOwner name: OTSUKA PHARMACEUTICAL FACTORY, INC., JAPANFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:TEZUKA, KENJI;HONDA, HIROSHI;KAGA, JUNJI;AND OTHERS;REEL/FRAME:017972/0033Effective date: 20051101RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services