CA2525053A1 - Sealing body, cap with the sealing body, and medical container - Google Patents
Sealing body, cap with the sealing body, and medical container Download PDFInfo
- Publication number
- CA2525053A1 CA2525053A1 CA002525053A CA2525053A CA2525053A1 CA 2525053 A1 CA2525053 A1 CA 2525053A1 CA 002525053 A CA002525053 A CA 002525053A CA 2525053 A CA2525053 A CA 2525053A CA 2525053 A1 CA2525053 A1 CA 2525053A1
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- Canada
- Prior art keywords
- sealing body
- needle stick
- cap
- hardness
- stick part
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 238000007789 sealing Methods 0.000 title claims abstract description 161
- 208000012266 Needlestick injury Diseases 0.000 claims abstract description 79
- 235000019589 hardness Nutrition 0.000 claims abstract description 63
- 229920002725 thermoplastic elastomer Polymers 0.000 claims abstract description 33
- 229920003023 plastic Polymers 0.000 claims abstract description 30
- 239000004033 plastic Substances 0.000 claims abstract description 30
- 238000003466 welding Methods 0.000 abstract description 6
- 238000001802 infusion Methods 0.000 description 33
- -1 polyethylene Polymers 0.000 description 12
- 238000004519 manufacturing process Methods 0.000 description 10
- 239000004698 Polyethylene Substances 0.000 description 6
- 229920001971 elastomer Polymers 0.000 description 6
- 239000000463 material Substances 0.000 description 6
- 239000000203 mixture Substances 0.000 description 6
- 229920000573 polyethylene Polymers 0.000 description 6
- 239000004743 Polypropylene Substances 0.000 description 5
- 230000000052 comparative effect Effects 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 230000002093 peripheral effect Effects 0.000 description 5
- 229920001155 polypropylene Polymers 0.000 description 5
- PPBRXRYQALVLMV-UHFFFAOYSA-N Styrene Chemical compound C=CC1=CC=CC=C1 PPBRXRYQALVLMV-UHFFFAOYSA-N 0.000 description 4
- 229920001400 block copolymer Polymers 0.000 description 4
- 238000010276 construction Methods 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 239000000806 elastomer Substances 0.000 description 3
- 239000012188 paraffin wax Substances 0.000 description 3
- 239000010734 process oil Substances 0.000 description 3
- 239000005060 rubber Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 229920005992 thermoplastic resin Polymers 0.000 description 3
- 239000004734 Polyphenylene sulfide Substances 0.000 description 2
- XECAHXYUAAWDEL-UHFFFAOYSA-N acrylonitrile butadiene styrene Chemical compound C=CC=C.C=CC#N.C=CC1=CC=CC=C1 XECAHXYUAAWDEL-UHFFFAOYSA-N 0.000 description 2
- 229920000122 acrylonitrile butadiene styrene Polymers 0.000 description 2
- 239000004676 acrylonitrile butadiene styrene Substances 0.000 description 2
- 239000013013 elastic material Substances 0.000 description 2
- BXOUVIIITJXIKB-UHFFFAOYSA-N ethene;styrene Chemical group C=C.C=CC1=CC=CC=C1 BXOUVIIITJXIKB-UHFFFAOYSA-N 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 239000003921 oil Substances 0.000 description 2
- 229920000139 polyethylene terephthalate Polymers 0.000 description 2
- 239000005020 polyethylene terephthalate Substances 0.000 description 2
- 229920000069 polyphenylene sulfide Polymers 0.000 description 2
- 229920000346 polystyrene-polyisoprene block-polystyrene Polymers 0.000 description 2
- 229920000468 styrene butadiene styrene block copolymer Polymers 0.000 description 2
- 239000004793 Polystyrene Substances 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 150000001336 alkenes Chemical class 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 101150059062 apln gene Proteins 0.000 description 1
- 150000001555 benzenes Chemical class 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 239000000428 dust Substances 0.000 description 1
- 229920005676 ethylene-propylene block copolymer Polymers 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- JRZJOMJEPLMPRA-UHFFFAOYSA-N olefin Natural products CCCCCCCC=C JRZJOMJEPLMPRA-UHFFFAOYSA-N 0.000 description 1
- 229920003050 poly-cycloolefin Polymers 0.000 description 1
- 229920001230 polyarylate Polymers 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 239000011112 polyethylene naphthalate Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 229920005996 polystyrene-poly(ethylene-butylene)-polystyrene Polymers 0.000 description 1
- 229920003225 polyurethane elastomer Polymers 0.000 description 1
- 229920006132 styrene block copolymer Polymers 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
- 125000000383 tetramethylene group Chemical group [H]C([H])([*:1])C([H])([H])C([H])([H])C([H])([H])[*:2] 0.000 description 1
- 229920001169 thermoplastic Polymers 0.000 description 1
- 239000004416 thermosoftening plastic Substances 0.000 description 1
- 239000010409 thin film Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1406—Septums, pierceable membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D51/00—Closures not otherwise provided for
- B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/20—Closure caps or plugs for connectors or open ends of tubes
Abstract
A generally disk-like sealing body (10) formed of two or more types of thermoplastic elastomers with different hardnesses, comprising a needle stick part (11) at least continued in the axial direction and an outer edge part (12) formed by surrounding the needle stick part. The sealing body is characterized in that the hardness of the outer edge part (12) is higher than that of the needle stick part (11), specifically, for example, a difference in hardness between the outer edge part and the needle stick part is 5 to 15 in accordance with JIS A Hardness. The sealing body can be used as a cap (15) by closely fitting it into a generally cylindrical outer frame body (16) formed of a hard plastic. Also, the sealing body can be used as a medical container by welding the cap (15) to the mouth part of the plastic container or plugging the sealing body (10) into the mouth part.
Description
' 1 DESCRIPTION
SEALING BODY, CAP WITH THE SEALING BODY, AND MEDICAL
CONTAINER
TECHNICAL FIELD
The present invention relates to a sealing body to be used for sealing a mouth part of a medical container such as an infusion bottle, an infusion bag or a vial, and a cap and a medical container each including such a sealing body.
BACKGROUND ART
An elastic material is used as a sealing body for sealing a mouth part of a medical container such as an infusion bottle, an infusion bag or a vial for containing a drug solution or a drug in consideration of the fact that the sealing body is stuck with a plastic sticking member (hollow needle) havingarelativelygreatdiameter.
In general, a rubber is used as the elastic material.
In recent years, a thermoplastic elastomer, which is advantageous in that it has a good moldability and little bleeding, has been used instead of the rubber ( see Japanese Unexamined Utility Model Publication No.
SH060 (1985) -147433) .
For improvement of the sealability of the sealing ' ' 2 body during the sticking with the sticking member, the sealing body should have a lower hardness. However, if the sealing body is composed of a thermoplastic elastomer having a lower hardness, the sealing body is more liable to warp during the sticking with the sticking member, resultingin handlingdifficulty. Further, thesticking member is more liable to come off from the sealing body due to reduction of the sticking member holding capability of the sealing body. Furthermore, the thermoplastic elastomer having a lower hardness has a higher tackiness, so that sealing bodies are more liable to adhere to each other. This hinders smooth flow of the sealing bodies in a production line.
On the other hand, if the sealing body is composed of a thermoplastic elastomer having a higher hardness, it is difficult to stick the sealing body with the sticking member. Further, the sealing body has a reduced sealability during the sticking with the sticking member or after withdrawal of the sticking member, thereby causing liquid leakage from the medical container.
Japanese Unexamined Patent Publication No.
HEIll(1999)-19177disclosesagenerallycolumnarsealing body 81 as shown in Fig. 7, which includes thermoplastic elastomer thin layers 82 to 84 stacked one on another, wherein an upper one and a lower one of the thin layers ' 3 have different elastic moduli. In Fig. 7, a reference character 80 denotes a cap, and a reference character 85 denotes an outer frame body.
However, even if the thermoplastic elastomer sealing body has the aforesaid layer structure, it is insufficient to solve the technical problems described above. In addition, it is impossible to alleviate the problemof the adhesion (tackiness) of the sealing bodies.
DISCLOSURE OF THE INVENTION
It is an object of the present invention to provide a thermoplastic elastomer sealing body which simultaneously ensures 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 is free from adhesion to other sealing bodies.
It is another object of the present invention to provide a cap and a medical container each including the aforesaid sealing body.
To solve the aforesaid problems, the present invention provides 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.
As described above, the inventive sealing body has at least two types of regions including the needle stick part and the outer edge part surrounding the needle stick part. Even if the thermoplastic elastomer for the needle stick part has a lower hardness to ensure easier sticking of the sealing body with a sticking member and sufficient sealability of the sealing body during the sticking, it is possible to ensure easier handling during the sticking of the sealing body with the sticking member and a sufficient sticking member holding capability because the thermoplastic elastomer for the outer edge part surrounding the needle stick part has a higher hardness.
Therefore, the easier sticking with the sticking member and the sufficient sealability during the sticking as well as the sufficient sticking member holding capability and the easier handling during the sticking can be simultaneouslyensured. Inaddition,theouteredgepart of the sealing body has a reduced adhesiveness because the thermoplastic elastomer for the outer edge part has a higher hardness. Hence, the adhesion between sealing bodies can be prevented. Therefore, the inventive sealing body is advantageously used as a sealing body for sealing a mouth part of a medical container such as an infusion bottle, an infusion bag or a vial.
In the inventive sealing body, the outer edge part 5 preferably has a JIS A hardness of 25 to 80, and the needle stick part preferably has a JI5 A hardness of 5 to 30.
Where the outer edge part and the needle stick part respectively have hardnesses within the aforesaid hardness ranges and the hardness of the outer edge part is higher than the hardness of the needle stick part, the ease of sticking with the sticking member, the sealability during the sticking, the sticking member holding capability and the ease of handling during the sticking can be further improved. In addition, the adhesion between sealing bodies can further assuredly be prevented.
In the present invention, "JIS A hardness" is a hardness Hs ( JIS A) determined by a spring hardness test (Type A) specified by "5. Hardness Test" in Japanese Industrial Standard JIS K 6301_1,-;~, (Physical Test Methods for vulcanized Rubbers).
In the inventive sealing body, the needle stick part of the thermoplastic elastomer having a lower hardness may include a single needle stick part or a plurality of needle stick parts, but the number of the ' 6 needle stick parts is not particularly limited.
Where the single needle stick part is provided in the sealing body, the needle stick part is preferably provided in a center portion of the sealing body and has a cylindrical shape. Further, the needle stick part preferably has a diameter which is 40 to 70% of the diameter of the entire sealing body. With the diameter of the needle stick part being within the aforesaid percentage range with respect to the diameter of the entire sealing body, a sufficient sealability during the sticking as well as a sufficient sticking member holding capability and easier handling during the sticking can further assuredly be provided.
The inventive sealing body may include two to five needle stick parts . With the provision of the plurality of needle stick parts (e. g. , the two to five needle stick parts) , the sealing body can be simultaneously stuck with a sticking needle for injecting a drug solution or air into a medical container having the sealing body and with a sticking needle for discharging a drug solution or air from the medical container, and a sticking position can be changed depending on the size and type of the sticking member to be used. Therefore, the sealing body, and a cap and a medical container each including the sealing body can be advantageously used and handled.
To solve the aforesaid problems, the present invention provides a cap which comprises the afore-said inventive sealing body being tightly fitted in a generally cylindrical outer flame body formed of a rigid plastic.
That is, examples of the cap include 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.
By tightly fitting the inventive sealing body in the generally cylindrical outer frame body formed of the rigid plastic, the inventive sealing body can be easily applied to a mouth part of a plastic medical container such as an infusion bottle or an infusion bag.
To solve the aforesaid problems, the present inventionalso providesthefollowing medicalcontainers.
(I) Amedical container made of plastic comprising the aforesaid inventive cap which is welded to a mouth part of the medical container.
That is, examples of the medical container include 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.
(II) A medical container comprising a mouth part, wherein the mouth part is tightly sealed by the aforesaid inventive sealing body That is, examples of the medical container include 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.
The medical container (I) is such that the inventive cap including the outer frame body formed of the rigid plastic is provided in the mouth part.
Therefore, the mouth part of the medical container per se should be weldable to the outer frame body of the cap.
Specific examples of the medical container (I) include plastic medical containers such as an infusion bottle and an infusion bag.
The medical container (II) is such that the inventive sealing body is fitted in the mouth part with no gap to seal the mouth part. The type of the medical container is not particularly limited, but the inner diameter of the mouth part of the medical container should conform to the outer diameter of the sealing body. This medical container is applicable not only to a plastic medical container such as an infusionbottle or an infusion bag but also to a medical container such as a vial.
BRIEF DESCRIPTION OF THE DRAWINGS
Figs. 1 (a), 1 (b) and 1 (c) are a plan view, a sectional view and a bottom view, respectively, illustrating a sealing body according to an embodiment of the present invention.
Fig. 2 is a sectional view illustrating a cap including the sealing body 10 of Fig. 1 according to the embodiment.
Fig. 3 is a front view illustrating, partly in section, amedical container (infusion bottle) including the sealing body 10 of Fig. 1 according to the embodiment.
Figs. 4 (a) , 4 (b) and 4 (c) are a plan view, a sectional view taken along a line A-A and a bottom view, 5 respectively, illustrating a sealing body according to another embodiment of the present invention.
Figs. 5(a), 5(b) and 5(c) are a plan view, a sectional view and a bottom view, respectively, illustrating a sealing body according to further another 10 embodiment of the present invention.
Fig. 6 is a sectional view illustrating a medical container (ampoule) including the sealing body 40 of Fig.
5 according to the further another embodiment.
Fig. 7 is a sectional view schematically illustrating a cap disclosed in Japanese Unexamined Patent Publication No. HEIll(1999)-191??.
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 0 of the diameter D1 of the entire sealing body 10.
A cap 15 shown in Fig. 2 and an infusion bottle 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 15 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 15b thereby to be fitted 20 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 lOc 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 15b. Projections 13a, 13b respectively provided on a top surface l0a and a bottom surface lOb of the sealing body 10 and a groove 13c provided in the top surface l0a of the sealing body 10 are engaged with the outer frame body 16 and the inner frame body 18, whereby the sealingbody ismore 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 17a, the cover 17 is pulled off. The cover 17 protects the tap surface l0a 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 31a to 31c.
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 42a provided on an outer peripheral surface 40a 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 40a 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 Anessentialrequirementfortheinventivesealing 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 5 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 10 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 15 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 improvementoftheweldability, thermoplasticelastomers 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 malefic acid or the like, a styrene-ethylene/propylene-styrene block copolymer (5EPS), a styrene-ethylene/butylene block copolymer (SEB) and a styrene-ethylenelpropylene 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.
S 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 bodyinclude various plastics includingpolyolefins such as polyethylene, polypropyleneand poly-9-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.
Amethod 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 ( I I ) ( a . 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 5 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 10 structurewasusedasthethermoplasticstyreneelastomer.
Aprocess 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 fromMitsui Chemicals Inc. ) having 15 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 23mm. A needle stick part 11 of the sealing body had a diameter D? of l2mm.
The ratio of the diameter D2 of the needle stick part 11 20 to the diameter D1 of the sealing body 10 was about 52%.
The sealing body 10 had a thickness of 5mm.
SEALING BODY, CAP WITH THE SEALING BODY, AND MEDICAL
CONTAINER
TECHNICAL FIELD
The present invention relates to a sealing body to be used for sealing a mouth part of a medical container such as an infusion bottle, an infusion bag or a vial, and a cap and a medical container each including such a sealing body.
BACKGROUND ART
An elastic material is used as a sealing body for sealing a mouth part of a medical container such as an infusion bottle, an infusion bag or a vial for containing a drug solution or a drug in consideration of the fact that the sealing body is stuck with a plastic sticking member (hollow needle) havingarelativelygreatdiameter.
In general, a rubber is used as the elastic material.
In recent years, a thermoplastic elastomer, which is advantageous in that it has a good moldability and little bleeding, has been used instead of the rubber ( see Japanese Unexamined Utility Model Publication No.
SH060 (1985) -147433) .
For improvement of the sealability of the sealing ' ' 2 body during the sticking with the sticking member, the sealing body should have a lower hardness. However, if the sealing body is composed of a thermoplastic elastomer having a lower hardness, the sealing body is more liable to warp during the sticking with the sticking member, resultingin handlingdifficulty. Further, thesticking member is more liable to come off from the sealing body due to reduction of the sticking member holding capability of the sealing body. Furthermore, the thermoplastic elastomer having a lower hardness has a higher tackiness, so that sealing bodies are more liable to adhere to each other. This hinders smooth flow of the sealing bodies in a production line.
On the other hand, if the sealing body is composed of a thermoplastic elastomer having a higher hardness, it is difficult to stick the sealing body with the sticking member. Further, the sealing body has a reduced sealability during the sticking with the sticking member or after withdrawal of the sticking member, thereby causing liquid leakage from the medical container.
Japanese Unexamined Patent Publication No.
HEIll(1999)-19177disclosesagenerallycolumnarsealing body 81 as shown in Fig. 7, which includes thermoplastic elastomer thin layers 82 to 84 stacked one on another, wherein an upper one and a lower one of the thin layers ' 3 have different elastic moduli. In Fig. 7, a reference character 80 denotes a cap, and a reference character 85 denotes an outer frame body.
However, even if the thermoplastic elastomer sealing body has the aforesaid layer structure, it is insufficient to solve the technical problems described above. In addition, it is impossible to alleviate the problemof the adhesion (tackiness) of the sealing bodies.
DISCLOSURE OF THE INVENTION
It is an object of the present invention to provide a thermoplastic elastomer sealing body which simultaneously ensures 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 is free from adhesion to other sealing bodies.
It is another object of the present invention to provide a cap and a medical container each including the aforesaid sealing body.
To solve the aforesaid problems, the present invention provides 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.
As described above, the inventive sealing body has at least two types of regions including the needle stick part and the outer edge part surrounding the needle stick part. Even if the thermoplastic elastomer for the needle stick part has a lower hardness to ensure easier sticking of the sealing body with a sticking member and sufficient sealability of the sealing body during the sticking, it is possible to ensure easier handling during the sticking of the sealing body with the sticking member and a sufficient sticking member holding capability because the thermoplastic elastomer for the outer edge part surrounding the needle stick part has a higher hardness.
Therefore, the easier sticking with the sticking member and the sufficient sealability during the sticking as well as the sufficient sticking member holding capability and the easier handling during the sticking can be simultaneouslyensured. Inaddition,theouteredgepart of the sealing body has a reduced adhesiveness because the thermoplastic elastomer for the outer edge part has a higher hardness. Hence, the adhesion between sealing bodies can be prevented. Therefore, the inventive sealing body is advantageously used as a sealing body for sealing a mouth part of a medical container such as an infusion bottle, an infusion bag or a vial.
In the inventive sealing body, the outer edge part 5 preferably has a JIS A hardness of 25 to 80, and the needle stick part preferably has a JI5 A hardness of 5 to 30.
Where the outer edge part and the needle stick part respectively have hardnesses within the aforesaid hardness ranges and the hardness of the outer edge part is higher than the hardness of the needle stick part, the ease of sticking with the sticking member, the sealability during the sticking, the sticking member holding capability and the ease of handling during the sticking can be further improved. In addition, the adhesion between sealing bodies can further assuredly be prevented.
In the present invention, "JIS A hardness" is a hardness Hs ( JIS A) determined by a spring hardness test (Type A) specified by "5. Hardness Test" in Japanese Industrial Standard JIS K 6301_1,-;~, (Physical Test Methods for vulcanized Rubbers).
In the inventive sealing body, the needle stick part of the thermoplastic elastomer having a lower hardness may include a single needle stick part or a plurality of needle stick parts, but the number of the ' 6 needle stick parts is not particularly limited.
Where the single needle stick part is provided in the sealing body, the needle stick part is preferably provided in a center portion of the sealing body and has a cylindrical shape. Further, the needle stick part preferably has a diameter which is 40 to 70% of the diameter of the entire sealing body. With the diameter of the needle stick part being within the aforesaid percentage range with respect to the diameter of the entire sealing body, a sufficient sealability during the sticking as well as a sufficient sticking member holding capability and easier handling during the sticking can further assuredly be provided.
The inventive sealing body may include two to five needle stick parts . With the provision of the plurality of needle stick parts (e. g. , the two to five needle stick parts) , the sealing body can be simultaneously stuck with a sticking needle for injecting a drug solution or air into a medical container having the sealing body and with a sticking needle for discharging a drug solution or air from the medical container, and a sticking position can be changed depending on the size and type of the sticking member to be used. Therefore, the sealing body, and a cap and a medical container each including the sealing body can be advantageously used and handled.
To solve the aforesaid problems, the present invention provides a cap which comprises the afore-said inventive sealing body being tightly fitted in a generally cylindrical outer flame body formed of a rigid plastic.
That is, examples of the cap include 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.
By tightly fitting the inventive sealing body in the generally cylindrical outer frame body formed of the rigid plastic, the inventive sealing body can be easily applied to a mouth part of a plastic medical container such as an infusion bottle or an infusion bag.
To solve the aforesaid problems, the present inventionalso providesthefollowing medicalcontainers.
(I) Amedical container made of plastic comprising the aforesaid inventive cap which is welded to a mouth part of the medical container.
That is, examples of the medical container include 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.
(II) A medical container comprising a mouth part, wherein the mouth part is tightly sealed by the aforesaid inventive sealing body That is, examples of the medical container include 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.
The medical container (I) is such that the inventive cap including the outer frame body formed of the rigid plastic is provided in the mouth part.
Therefore, the mouth part of the medical container per se should be weldable to the outer frame body of the cap.
Specific examples of the medical container (I) include plastic medical containers such as an infusion bottle and an infusion bag.
The medical container (II) is such that the inventive sealing body is fitted in the mouth part with no gap to seal the mouth part. The type of the medical container is not particularly limited, but the inner diameter of the mouth part of the medical container should conform to the outer diameter of the sealing body. This medical container is applicable not only to a plastic medical container such as an infusionbottle or an infusion bag but also to a medical container such as a vial.
BRIEF DESCRIPTION OF THE DRAWINGS
Figs. 1 (a), 1 (b) and 1 (c) are a plan view, a sectional view and a bottom view, respectively, illustrating a sealing body according to an embodiment of the present invention.
Fig. 2 is a sectional view illustrating a cap including the sealing body 10 of Fig. 1 according to the embodiment.
Fig. 3 is a front view illustrating, partly in section, amedical container (infusion bottle) including the sealing body 10 of Fig. 1 according to the embodiment.
Figs. 4 (a) , 4 (b) and 4 (c) are a plan view, a sectional view taken along a line A-A and a bottom view, 5 respectively, illustrating a sealing body according to another embodiment of the present invention.
Figs. 5(a), 5(b) and 5(c) are a plan view, a sectional view and a bottom view, respectively, illustrating a sealing body according to further another 10 embodiment of the present invention.
Fig. 6 is a sectional view illustrating a medical container (ampoule) including the sealing body 40 of Fig.
5 according to the further another embodiment.
Fig. 7 is a sectional view schematically illustrating a cap disclosed in Japanese Unexamined Patent Publication No. HEIll(1999)-191??.
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 0 of the diameter D1 of the entire sealing body 10.
A cap 15 shown in Fig. 2 and an infusion bottle 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 15 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 15b thereby to be fitted 20 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 lOc 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 15b. Projections 13a, 13b respectively provided on a top surface l0a and a bottom surface lOb of the sealing body 10 and a groove 13c provided in the top surface l0a of the sealing body 10 are engaged with the outer frame body 16 and the inner frame body 18, whereby the sealingbody ismore 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 17a, the cover 17 is pulled off. The cover 17 protects the tap surface l0a 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 31a to 31c.
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 42a provided on an outer peripheral surface 40a 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 40a 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 Anessentialrequirementfortheinventivesealing 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 5 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 10 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 15 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 improvementoftheweldability, thermoplasticelastomers 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 malefic acid or the like, a styrene-ethylene/propylene-styrene block copolymer (5EPS), a styrene-ethylene/butylene block copolymer (SEB) and a styrene-ethylenelpropylene 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.
S 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 bodyinclude various plastics includingpolyolefins such as polyethylene, polypropyleneand poly-9-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.
Amethod 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 ( I I ) ( a . 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 5 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 10 structurewasusedasthethermoplasticstyreneelastomer.
Aprocess 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 fromMitsui Chemicals Inc. ) having 15 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 23mm. A needle stick part 11 of the sealing body had a diameter D? of l2mm.
The ratio of the diameter D2 of the needle stick part 11 20 to the diameter D1 of the sealing body 10 was about 52%.
The sealing body 10 had a thickness of 5mm.
(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 15b. An inner frame body 18 is inserted into the outer frame body 16 from the side of the bottom 15b, 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 15b 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 (100mL) 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 l, 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 ' ' 22 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 l, 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 sealingbody 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 2.5mm and a diameter of 23mm were respectively injection-molded from the aforesaid compas itions 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 4mm, 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 inj ected 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 0.06MPa, 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 0.04MPa.
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 thepresent invention simultaneouslyensure 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.
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 l, 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 ' ' 22 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 l, 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 sealingbody 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 2.5mm and a diameter of 23mm were respectively injection-molded from the aforesaid compas itions 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 4mm, 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 inj ected 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 0.06MPa, 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 0.04MPa.
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 thepresent invention simultaneouslyensure 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.
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 10mm and a diameter of 10 to 40mm.
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.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2003-145250 | 2003-05-22 | ||
| JP2003145250 | 2003-05-22 | ||
| PCT/JP2004/006988 WO2004103453A1 (en) | 2003-05-22 | 2004-05-17 | Sealing body, cap with the sealing body, and medical container |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2525053A1 true CA2525053A1 (en) | 2004-12-02 |
Family
ID=33475230
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002525053A Abandoned CA2525053A1 (en) | 2003-05-22 | 2004-05-17 | Sealing body, cap with the sealing body, and medical container |
Country Status (9)
| Country | Link |
|---|---|
| US (1) | US20070066941A1 (en) |
| EP (1) | EP1625873A1 (en) |
| JP (1) | JPWO2004103453A1 (en) |
| KR (1) | KR20060010822A (en) |
| CN (1) | CN1795026A (en) |
| AU (1) | AU2004241854A1 (en) |
| CA (1) | CA2525053A1 (en) |
| TW (1) | TW200505404A (en) |
| WO (1) | WO2004103453A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107405256A (en) * | 2015-03-27 | 2017-11-28 | 费森尤斯卡比德国有限公司 | For the closing cap for the container for holding medical fluid |
Families Citing this family (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB0511431D0 (en) * | 2005-06-04 | 2005-07-13 | Vascutek Ltd | Graft |
| JP4995620B2 (en) * | 2007-04-20 | 2012-08-08 | アロン化成株式会社 | Thermoplastic elastomer composition and cover for mouth plug for chemical container using the same |
| JP4904501B2 (en) * | 2007-06-12 | 2012-03-28 | 内外化成株式会社 | Infusion cap |
| JP5100526B2 (en) * | 2008-06-17 | 2012-12-19 | 株式会社大塚製薬工場 | Container stopper member and chemical container |
| DE102009009415A1 (en) * | 2009-02-18 | 2010-08-26 | Heipha Gmbh | Container with a septum closure and cap with septum closure |
| EP2660163B1 (en) * | 2010-12-28 | 2018-11-28 | Nipro Corporation | Rubber stopper for vial |
| KR101273894B1 (en) * | 2011-09-28 | 2013-06-17 | 제이더블유생명과학 주식회사 | Ring-off Type Medical Cap and Cleaning Container for Medical Devices Employing Thereof |
| KR101380089B1 (en) * | 2012-06-08 | 2014-04-02 | 이종규 | Sealing cap cnnected to injection port for infusion solution pack |
| DE102012021525A1 (en) * | 2012-10-31 | 2014-04-30 | Kocher-Plastik Maschinenbau Gmbh | Sealing arrangement and such an associated container |
| JP6103891B2 (en) * | 2012-11-12 | 2017-03-29 | 三笠産業株式会社 | Medical cap |
| CN105899440B (en) * | 2014-01-08 | 2018-09-14 | 株式会社大塚制药工场 | Lid |
| TWI696461B (en) * | 2015-01-21 | 2020-06-21 | 日商大塚製藥工場股份有限公司 | Method for producing port, and method for producing medical liquid bag |
| WO2016187557A1 (en) * | 2015-05-21 | 2016-11-24 | Csp Technologies, Inc. | Fluid receiver fitting for aseptic fluid transfer and methods for making the same |
| DE102015006489A1 (en) * | 2015-05-22 | 2016-11-24 | Kocher-Plastik Maschinenbau Gmbh | Plastic container product |
| JP6587492B2 (en) * | 2015-10-15 | 2019-10-09 | 日本山村硝子株式会社 | Cap and container equipped with the cap |
| JP6860303B2 (en) * | 2016-07-15 | 2021-04-14 | ロート製薬株式会社 | Chemical container |
| JP7049760B2 (en) * | 2016-07-15 | 2022-04-07 | ロート製薬株式会社 | Eye drop container |
| DE102016012059A1 (en) | 2016-10-08 | 2018-04-12 | Fresenius Kabi Deutschland Gmbh | Connector for a liquid containing medical packaging |
| CN109125067A (en) * | 2018-03-05 | 2019-01-04 | 上海太平洋实业有限公司 | A kind of double-colored combined cap of infusion plastic bottle |
| KR102024308B1 (en) * | 2018-04-23 | 2019-09-23 | 씨제이헬스케어 주식회사 | Port for medical solution bag |
| WO2023148317A1 (en) * | 2022-02-04 | 2023-08-10 | Fresenius Kabi Deutschland Gmbh | Closure cap for a medical container and method for assembly thereof |
| WO2024073402A1 (en) * | 2022-09-30 | 2024-04-04 | Integrated Liner Technologies, Inc. | Insert and cap assembly for transmitting electromagnetic waves and methods of using thereof |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2099370A (en) * | 1935-09-07 | 1937-11-16 | Monnier Vital | Phial |
| US2153981A (en) * | 1936-04-03 | 1939-04-11 | Winthrop Chem Co Inc | Medicinal container |
| US2579724A (en) * | 1946-04-15 | 1951-12-25 | Breakstone Seymour | Valved closure plug for insertion in the neck of a bottle |
| US3343699A (en) * | 1966-02-09 | 1967-09-26 | Flake Ice Machines Inc | Combination cap and tapping plug for spouts, bottles or the like |
| US3496969A (en) * | 1967-05-12 | 1970-02-24 | Sterigard Corp | Valve for pressurizing a container |
| US4187952A (en) * | 1976-03-04 | 1980-02-12 | Becton, Dickinson And Company | Cannula pierceable, self-sealing closure |
| JPS55101758U (en) * | 1979-01-11 | 1980-07-15 | ||
| JPS60147433U (en) * | 1984-03-09 | 1985-09-30 | 岸本産業株式会社 | medical container cap |
| US5215537A (en) * | 1990-09-13 | 1993-06-01 | Lynn Lawrence A | Septum for a blunt cannula |
| DE4112209A1 (en) * | 1991-04-13 | 1992-10-15 | Behringwerke Ag | CONTAINER CLOSURE WITH PUSHABLE BODY |
| AU1938395A (en) * | 1994-03-04 | 1995-09-18 | Mentor Corporation | Self-sealing injection sites and method of manufacture |
| JPH11263357A (en) * | 1998-03-18 | 1999-09-28 | Terumo Corp | Medical container plug |
| CA2262477C (en) * | 1998-05-16 | 2008-02-12 | Bracco International B.V. | Multiple use universal stopper |
| JP3570938B2 (en) * | 1999-08-23 | 2004-09-29 | 大成プラス株式会社 | Method of manufacturing a needle puncture stopper |
| US6604561B2 (en) * | 2000-02-11 | 2003-08-12 | Medical Instill Technologies, Inc. | Medicament vial having a heat-sealable cap, and apparatus and method for filling the vial |
| JP2002065810A (en) * | 2000-08-29 | 2002-03-05 | Ohtsu Tire & Rubber Co Ltd :The | Medical rubber plug |
-
2004
- 2004-05-17 JP JP2005506369A patent/JPWO2004103453A1/en active Pending
- 2004-05-17 CA CA002525053A patent/CA2525053A1/en not_active Abandoned
- 2004-05-17 CN CNA2004800141199A patent/CN1795026A/en active Pending
- 2004-05-17 US US10/557,842 patent/US20070066941A1/en not_active Abandoned
- 2004-05-17 WO PCT/JP2004/006988 patent/WO2004103453A1/en not_active Application Discontinuation
- 2004-05-17 KR KR1020057022159A patent/KR20060010822A/en not_active Application Discontinuation
- 2004-05-17 AU AU2004241854A patent/AU2004241854A1/en not_active Abandoned
- 2004-05-17 EP EP04733455A patent/EP1625873A1/en not_active Withdrawn
- 2004-05-21 TW TW093114410A patent/TW200505404A/en unknown
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107405256A (en) * | 2015-03-27 | 2017-11-28 | 费森尤斯卡比德国有限公司 | For the closing cap for the container for holding medical fluid |
Also Published As
| Publication number | Publication date |
|---|---|
| KR20060010822A (en) | 2006-02-02 |
| US20070066941A1 (en) | 2007-03-22 |
| AU2004241854A1 (en) | 2004-12-02 |
| TW200505404A (en) | 2005-02-16 |
| CN1795026A (en) | 2006-06-28 |
| EP1625873A1 (en) | 2006-02-15 |
| WO2004103453A1 (en) | 2004-12-02 |
| JPWO2004103453A1 (en) | 2006-07-20 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |