WO2002056820A1 - Closure cap apparatus for medicament bottle using shape memory alloy - Google Patents

Closure cap apparatus for medicament bottle using shape memory alloy Download PDF

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Publication number
WO2002056820A1
WO2002056820A1 PCT/KR2001/001839 KR0101839W WO02056820A1 WO 2002056820 A1 WO2002056820 A1 WO 2002056820A1 KR 0101839 W KR0101839 W KR 0101839W WO 02056820 A1 WO02056820 A1 WO 02056820A1
Authority
WO
WIPO (PCT)
Prior art keywords
closure cap
bottle
shape
shape memory
temperature sensor
Prior art date
Application number
PCT/KR2001/001839
Other languages
French (fr)
Inventor
Ji-Hoon Park
Original Assignee
Gmpbio Co., Ltd.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Gmpbio Co., Ltd. filed Critical Gmpbio Co., Ltd.
Publication of WO2002056820A1 publication Critical patent/WO2002056820A1/en

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS 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
    • B65D79/00Kinds or details of packages, not otherwise provided for
    • B65D79/02Arrangements or devices for indicating incorrect storage or transport
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01KMEASURING TEMPERATURE; MEASURING QUANTITY OF HEAT; THERMALLY-SENSITIVE ELEMENTS NOT OTHERWISE PROVIDED FOR
    • G01K5/00Measuring temperature based on the expansion or contraction of a material
    • G01K5/48Measuring temperature based on the expansion or contraction of a material the material being a solid
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS 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
    • B65D51/00Closures not otherwise provided for
    • B65D51/002Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means

Definitions

  • the invention is related to a cap for a medicament bottle, and particularly, to a closure cap apparatus for medicament bottle or vial to be stored under the freezing or refrigerating condition using a shape memory ally.
  • the invention is related to providing a closure cap apparatus for medicament bottles or vials, with which a shape memory alloy having first and second shapes changed according to the surroundings temperature is provided, in which the shape memory alloy is kept at the second shape to permit the medicament stored in the bottle to be used during the freezing or refrigerating storage at a proper temperature and, on the contrary, changed into the first shape to enable the use of the medicament to be prohibited with anxiety of its damage, if it is exposed to a room temperature or over a critical temperature for a long time, even temporarily.
  • a conventional metal material keeps the deformed shape after being plastic deformed over the limitation of its elastic coefficient.
  • a shape memory alloy (called “SMA” below) has its own inherent property to return to its original shape, when the deformation cause disappears, or the deformed SMA is heat-processed at above its transformation temperature after the plastic deformation at a yield point.
  • SMA shape memory alloy
  • alloys of a Ti-Ni type, Cu type, a Fe type, etc. which are known by studies of their properties of Martensitic deformation and the shape memory and their crystal structures at a lower or higher temperature. Therefore, the SMA is now used in various fields. Particularly, the SMA is heat-treated to be used as a specific element or to have a specific shape for a predetermined purpose of a shape memory related to a temperature.
  • the SMA has been applied to a functional device provided in an actuator, etc. in a higher precision part and a temperature sensor, and also has been used as a fixing part that is simply fixed to a product in the form of a plate, a wire, etc. for indicating a temperature by being returned to its own inherent shape beyond a predetermined deformation temperature.
  • the fixing part has been used in easily identifying whether frozen products including frozen meats, etc., and cold storage foodstuffs including milk are exposed to a critical temperature during being processed or transported.
  • a typical technology of a temperature sensor using an SMA is disclosed in US Patent No. 5,735,607.
  • the patent is related to shape memory alloy thaw sensors for providing persistent indication of the damage of food products such as frozen dairy products and frozen meats spoiled upon being exposed to thawing temperatures for even a short time and frozen medical products such as blood and certain pharmaceuticals unstable once exposed to thawing or other high temperatures, even if the temperature later returns to a safe value, which causes due to the improper handling or cooling equipment malfunction in transportation or during being processed, whereby the careless use of these products is prevented.
  • the SMA sensor changes a shape at its Austenitic temperature, and will not return to its original shape in the Martensitic phase if the temperature returns to the original value.
  • the SMA sensor at least one member having a first shape at temperatures below a critical temperature and a second shape at temperatures above the critical temperature, where each member assumes the second shape when the temperature rises above the critical temperature but does not return to the first shape when the temperature falls below the critical temperature; and a plurality of indicators mounted with the members, where the indicators obscure the indication surface when the members are in the first shape, and where the indicators do not obscure the indication surface when the members are in their second shape.
  • the patent further comprises a structure for preventing the shape memory alloy member from being returned to the first shape after being made into the second shape according to its changing property, which makes the total configuration of the thaw sensor complex.
  • the thaw sensor is not forced to use the change of the inherent shape of the shape memory alloy. Therefore, this thaw sensor has disadvantages in that it is expensive and available only for a specific product, not for a general cheaper product. Further, the use of the thaw sensor must be accompanied with a cumbersome process of properly attaching the base to the product in advance for mounting the thaw sensor thereon. In order to confirm the operation of the thaw sensor, the state of an indicator on the base must be carefully checked.
  • the vial 10 includes a bottle 1 for storing injection medicine, a bung 2 clogged in an upper mouth of the bottle and made of an antibiotics or an aseptic material, a sleeve made of a silver and an aluminium and for preventing the removal of the bung 2 from the bottle 1 and a cap 4 covered on the bung 2 and made of a plastic and an aluminium. Therefore, when the vial 10 is assembled, an amount of injection medicine is filled into the bottle 1.
  • the bung 2 is plugged into the mouth of the bottle 1.
  • the sleeve 3 is partly covered onto the bung 2 and pressed around the peripheral of the bottle mouth to be not removed therefrom.
  • the cap 4 is fixed onto the sleeve 3.
  • the vial 10 includes a general closure configuration independent of the peripheral temperature, which makes it impossible to discriminate its storage state. For it, if the vial containing medicaments is stored for a long period at a normal temperature or above a critical temperature, it is anxious that the medicament could go bad or be deteriorating.
  • the closure also is supposed to be not able to determine through naked eyes whether the medicine product in the bottle is normal resulting from the freezing or refrigerating storage at below a critical temperature or deteriorates due to the exposure to a normal temperature or above the critical temperature. And, the invention fails to suggest any protective measure against the deterioration of the medicine product.
  • such like cap closure containing the medicine product has disadvantages in that it is inconvenient to identify the change of the cap in order to discriminate the spoilage of the medicine product. Also, it is difficult to determine whether the medicine product is stored under a normal state or wrongly stored at above the critical temperature due to an accident influencing on the bottle or vial thereby to go bad.
  • an object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament for enabling the medicament to be stored in the freezing or refrigerating condition to determine whether it is normal or deteriorates using a shape memory alloy.
  • Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy which is kept at a second shape under the freezing or refrigerating storage of medicine products or medicaments at below a critical temperature to allow the use of the medicament and, on the contrary, changed into a first shape to enable the use of the medicament to be prohibited with anxiety of its damage, if it is exposed to a room temperature or over a critical temperature for a long time, even temporarily.
  • Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy which is kept at a second shape to permit the removal of the closure cap apparatus from the vials at below a critical temperature and, on the contrary, to be changed into a first shape to prevent the removal of the closure cap apparatus from the vials at above the critical temperature.
  • Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy, which includes a closure cap control means to be kept at a second shape for permitting the removal of the closure cap apparatus from the vials at below a critical temperature and, on the contrary, changed into a first shape in order to prevent the removal of the closure cap apparatus from the vials at above the critical temperature.
  • Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy which is kept at a second shape to indicate the normal state of the medicament on the closure cap apparatus at below a critical temperature and, on the contrary, changed into a first shape to indicate the abnormal state of the medicament or a warning for the use prohibition on the closure cap apparatus at above the critical temperature.
  • Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy, which includes an indicating means to be kept at a second shape at below a critical temperature and, on the contrary, to be changed into a first shape in order to indicate the damage of the medicament at above the critical temperature.
  • Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy, which includes means for preventing the malfunction of the shape memory alloy that is kept at a second shape at below a critical temperature and changed into a first shape at above the critical temperature, setting the storage state of the medicament and indicating whether the medicament is damaged or not.
  • a closure cap apparatus using a shape memory alloy is adapted to a vial including a bottle containing injection medicine, medicine products or medicaments, etc., a rubber bung sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve fitted onto the upper mouth of the bottle above the rubber bung.
  • the closure cap apparatus comprises a sleeve including a cylindrical portion surrounding a rim portion of the medicament bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact with the lower edge of the rim portion by a predetermined clamping tool; a closure cap of a two stories structure, which is made of a plastic or synthetic resin, including a receiving portion positioned in the sleeve, two annular portions of a crescentic shape integrally projected from the receiving portion to be arranged against each other and a stopper including flaps formed upright on the diameter line of the closure cap between the two annular portions to control the removal of the closure cap from the vial and a circular plate integrated with the flaps and connected on the diameter line to the inner lower portion of the annular portions; and a temperature sensor positioned on the lower surface to have a second shape at below a critical temperature and a first shape at above
  • the stopper includes the circular plate positioned around the inner lower circumference of the annular portion and flaps extended from the circular plate in the form of the inner and upper walls of the annular portion and between both ends of the annular portions, in which the circular plate includes a folding portion having a predetermined width formed on both sides by reference of a scoring line of a diameter thereof, a hole formed at the center to insert an operating portion of the temperature sensor for the folding portion and connecting portions formed at both ends to be fixed to the inner lower circumference of the annular portion.
  • a closure cap apparatus comprises a sleeve including a cylindrical portion surrounding a rim portion of the bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact with the lower edge of the rim portion by a predetermined clamping tool; a closure cap of a two stories structure including a receiving portion provided with a cylindrical wall for forming a cylindrical body and an upper surface positioned in the sleeve, annular portions provided with a mounting portion integrally projected from a circumferential arc of a predetermined diameter on the upper surface of the receiving portion and then horizontally extended in a predetermined width therefrom with the front surface being opened, flaps extended outward from both sides of the diameter line to prevent the removal of a temperature sensor from the mounting portion and a cutting line formed on the upper surface around the outer circumference of the mounting portion; and the temperature sensor of an O
  • the temperature sensor is positioned in the mounting portion to surround the circumferential wall of the mounting portion which is kept at the second shape of an oval at below a critical temperature to allow the removal thereof from the annular portion and expanded into the first shape of a circle at above the critical temperature to prevent the removal thereof from the annular portion.
  • a closure cap apparatus is adapted to a vial including a bottle containing injection medicine, medicine products or medicament, etc., a rubber bung sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve fitted onto the upper mouth of the bottle above the rubber bung.
  • the closure cap apparatus comprises a sleeve including a cylindrical portion surrounding a rim portion of the bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact with the lower edge of the rim portion by a predetermined clamping tool; a temperature sensor of an O ring type changed in its diameter to have a second shape of an oval at below a critical temperature and a first shape of a circle at over a critical temperature; and a closure cap including an operating control member provided with a thickness portion of an oval similar to the temperature sensor, a guide plate formed on both sides of the narrow diameter line thereof and a plurality of push buttons projected from the upper surface to be inserted into a plurality of through-holes formed on tlie upper surface thereof to correspond to each another and at least one moving indication member arranged on the lower surface of the operating control member to surround the temperature sensor and including a moving member with a rectangular
  • the closure cap comprises a plurality of ribs projected a little from the upper surface to facilitate the identification thereof through naked eyes, at least two identification holes formed at places different from each another on the upper surface to permit the storage stage of a product in the medicament bottle to be identified, a plurality of through-holes formed in a concentric circle interval spaced form each another on the upper surface to be coupled with the corresponding push button of the moving indication members, a projecting portion formed at a center area to be used as a supporting jaw in the course of the press processing at the time of being assembled with the bottle, an oval portion formed at the center area and arrow portions formed on both sides of the oval portion to indicate the direction that the operating control portion is moved.
  • the closure cap comprises a guide shaft integrally projected from the upper inner center and including a guide slit formed in a direction to guide the up and down movement of the operating control member, a guide groove formed on the upper inner surface to guide the straight movement of the moving indication members in the same direction as that of the slit, at least one pair of first supporting walls formed in a symmetric with respect to each another to provides oval hollow portions for the moving indication members and at least one pair of second supporting walls integrally projected from the upper inner surface to provide hollow portions for the moving indication members.
  • the operating control member includes a plurality of push buttons to be inserted into the corresponding button hole of the closure cap and a guide plate integrated therewith to be slidably moved in the slit of the center shaft on the upper inner surface of the closure cap.
  • the moving indication members include a crescentic body having a predetermined limited length and an indicating bar projected in a predetermined length from the upper center portion of the crescent body.
  • a lower opening portion of the closure cap includes a separate plastic partition and adhesives applied thereon to fix the closure cap on the upper surface of the rubber bung or attach the closure cap to an upper portion of a container such as a vinyl package, etc.
  • At least two moving indication members are positioned in a guide groove portion separated from each another and include an U-characterized body formed to force the temperature sensor to be fitted thereinto, one side of which is projected to function as an indicating portion, and other side of which is extended to position its free end in the slit of the guide shaft.
  • the moving indication member is made of a plastic processing material having any colour to facilitate the identification thereof through naked eyes.
  • a numerical value, character or indication is provided on the periphery of the identification holes.
  • a closure cap apparatus is adapted to a vial including a bottle containing injection medicine, medicine products or medicament, etc., a rubber bung sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve fitted onto the upper mouth of the bottle above the rubber bung.
  • the closure cap apparatus comprises a sleeve including a cylindrical portion surrounding a rim portion of the bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact, with the lower edge of the rim portion by a predetermined clamping tool; a temperature sensor changed at its diameter to have a second shape of an oval at below a critical temperature and a first shape of a regular circle at above a critical temperature; and a closure cap including a housing projected in a predetermined width from the upper surface from the center close to the circumference thereof, at least one identification hole formed on the housing to permit the storage state or the exposure of the medicament to over a critical temperature to be identified through naked eyes, a C-shaped moving indication member including a groove portion formed to fit one arc portion of the temperature sensor thereinto and a projecting portion projected from the center to be used as a supporting jaw in the time of its press processing for
  • the closure cap comprises a center shaft integrally projected from the upper inner center thereof, receiving wall portions formed downward corresponding to both side walls of the housing by the reference of the center shaft to slidably receive the moving indication member between the receiving wall portions, first supporting walls projected downward in an arc adjacent to the wall portion thereof, second supporting walls projected downward in an arc adjacent to the wall portion thereof to be faced against the first supporting walls and approximate wall portions projected downward to form a space for positioning an arc portion of the temperature sensor in part in a hollow portion formed by the second wall portions and the approximate wall portions.
  • Fig. 1 is a separate perspective view illustrating a configuration that a cap is adapted to a vial according to a prior art
  • Fig. 2 is a separate perspective view illustrating a configuration that a closure cap apparatus is adapted to a medicament bottle according to a first embodiment of the invention
  • Fig. 3 is a cross-sectional perspective view illustrating the state that a closure cap apparatus is partly cut out
  • Fig. 4 is a rear perspective view illustrating the assembly of a temperature sensor and a stopper into the closure cap apparatus according to the first embodiment of the invention
  • Fig. 5 is a cross-sectional perspective view illustrating the operating of the stopper according to the first embodiment of the invention, when the temperature sensor is made into a second shape at below a critical temperature;
  • Fig. 6 is a cross-sectional perspective view illustrating the operating of the stopper according to the first embodiment of the invention, when the temperature sensor is made into a first shape at below the critical temperature;
  • Fig. 7 is a perspective view illustrating the use state of the closure cap apparatus mounted in the bottle according to the first embodiment of the invention.
  • Fig. 8 is a perspective view illustrating the removal of the stopper from the closure cap apparatus according to the first embodiment of the invention.
  • Fig. 9 is a perspective view illustrating a closure cap partly cut out according to another embodiment of the closure cap apparatus.
  • Fig. 10 is a top view illustrating the upper surface of the closure cap according to another embodiment of the closure cap apparatus
  • Fig. 11 is a cross-sectional view illustrating the operating of the temperature sensor mounted on the closure cap according to another embodiment of the closure cap apparatus;
  • Fig. 12A is an exploded perspective view illustrating a closure cap apparatus according to a second embodiment of the invention.
  • Fig. 12B is a perspective view illustrating another example of a moving indication member mounted in the closure cap apparatus according to the second embodiment of the invention.
  • Fig. 13 is a rear perspective view illustrating the configuration of the closure cap according to the second embodiment of the invention.
  • Fig. 14A is a cross-sectional view illustrating the assembly of an operating control member, a temperature sensor and a moving indication member into the closure cap apparatus and their operating according to the second embodiment of the invention
  • Fig. 14B is a cross-sectional view illustrating the initial operating state of the closure cap apparatus related to a second shape of the temperature sensor according to the second embodiment of the invention
  • Fig. 14C is a cross-sectional view illustrating the operating state of the closure cap apparatus at the time of being partly changed into a first shape of the temperature sensor according to the second embodiment of the invention
  • Fig. 14D is a cross-sectional view illustrating the operating state of the closure cap apparatus at the time of being fully changed into the first shape of the temperature sensor according to the second embodiment of the invention
  • Fig. 15 is a front perspective view illustrating a closure cap according to another example of the second embodiment
  • Fig. 16 is a perspective view illustrating a closure cap apparatus according to a third embodiment of the invention.
  • Fig. 17 is a rear perspective view illustrating the assembly of a temperature sensor and a moving indication member into the closure cap apparatus according to the third embodiment of the invention.
  • Fig. 18A is a perspective view illustrating the closure cap apparatus, on which the moving indication member cannot be identified during the normal storage of a freezing or refrigerating product;
  • Fig. 18B is a perspective view illustrating the closure cap apparatus, on which the moving indication member can be identified during the abnormal storage of a freezing or refrigerating product.
  • a closure cap apparatus is mounted on a vial and operated according to a first embodiment of the invention.
  • the closure cap apparatus is adapted to a bottle, container or vial 10 containing refined medicine products or medicaments of a solid or liquor such as a Vaccine, Penicillin, etc.
  • a vial comprises a medicament bottle 1, a rubber bung 2 fitted into the mouth of the medicament bottle 1, a sleeve 3 for preventing the removal of the rubber bung 2 and a closure cap 30 covered on the sleeve 3.
  • a closure cap apparatus comprises the sleeve 3 and the closure cap 30.
  • the closure cap apparatus further comprises a temperature sensor 20 made of a shape memory alloy, which has a second shape at below a critical temperature and a first shape at above a critical temperature.
  • the temperature sensor 20 prevents the separation or removal of the closure cap 30 from the vial 10 to control the use of a solid medicament or injection fluid contained in the medicament bottle 1.
  • the closure cap 30 is assembled into the sleeve 3 in advance and fixed on the rubber bung 2 at the same time to seal the medicament bottle 1.
  • the medicament bottle 1 includes an open end 11, an annular rim portion 12 radially extended from the open end 11 and a neck portion 13 adjacent the rim portion 12.
  • the open end 11 of the medicament bottle 1 is typically closed with an elastic rubber bung 2, which includes a tubular body portion 14 that is received in the open end 11 of the medicament bottle 1 and a planar flange portion 15, which overlies the rim portion 12 of the medicament bottle 1.
  • the central portion of the rubber bung 2 is pierced with a hypodermic needle, for example, to either withdraw fluid from the vial 10 or add a solvent or diluent to the vial 10 where the medicament in the vial 10 is a dry or powder drug.
  • the sleeve 3 includes a cylindrical portion 16 which surrounds the rim portion 12 of the medicament bottle 1, a flange 15 of the rubber bung 2 and a tubular wall portion 31 of the closure cap 30 as described below. Also, the sleeve 3 includes an extending portion horizontally extended in a predetermined length from the cylindrical portion 16, a hole 18 formed at the center thereof and a free end portion 19 bent inward from around the circumference in contact with the lower edge of the rim portion by a predetermined tool.
  • the closure cap 30 is formed as an integral two stories structure made of a plastic or synthetic resin and includes a receiving portion 33 positioned in the sleeve 3, two annular portions 34 and 35 of a crescentic shape integrally projected from the receiving portion to be arranged against each other and a stopper 40 for controlling the separation or removal of the closure cap 30 from the vial 10, in which the stopper 40 includes flaps 42 formed upright on both sides of the diameter line of the closure cap 30 between the two annular portions 34 and 35 and a circular plate 41 integrated with the flaps 42 and connected at the diameter line to the inner lower portion of the annular portions 34 and 35.
  • the receiving portion 33 includes a wall portion 31 positioned adjacent the inner surface of the cylindrical 16 and a circumferential portion 32 radially and horizontally extended inward in a predetermined length from the wall portion.
  • the stopper 40 includes the circular plate positioned around the inner lower circumference of the annular portions 34 and 35 and the flaps 42 each extended from the circular plate 41 to the spaces between both ends of the annular portions 34 and 35 in a form similar to the inner and upper walls of the annular portions 34 and 35.
  • a folding portion 44 is formed on the circular plate 41 to have a predetermined width formed on both sides by reference of a scoring line 34 of a diameter line thereof.
  • a hole 45 is formed at the center of the circular plate 41 to permit an operating portion 21 of the temperature sensor 20 to be inserted thereinto.
  • a connecting portion 46 is integrally extended from ends of the folding portion 44 to connect the circular plate 41 to the inner lower circumferences of the annular portions 34 and 35.
  • Supporting portion s 47 is formed on the circular plate 42 close to the folding portion 44 to wrap around the temperature sensor 20 for supporting.
  • the temperature sensor 20 is positioned on the lower surface of the circular plate 41 and includes the operating portion 21 formed at the center to have a second shape at below a critical temperature and a first shape at above a critical temperature and length portions 22 and 23 extended in a predetermined length from the operating portion 21, thereby controlling the operating of the flaps 42.
  • the stopper 40 is integrally moulded with the closure cap 30 at the time of being manufactured.
  • the connecting portions 46 are connected at the diameter line to the inner lower circumferences of the annular portions 34 and 35. Except it, the circular plate 41 and the flaps 42 are moulded into the closure cap 30 with being separated from the annular portions 34 and 35. Also, as not shown in Fig. 3, at least two bridges are formed on the side surfaces of the flaps 42. Therefore, the closure cap 30 is moulded to be integrated with the receiving portion 30, the annular portions 34 and 35 and the stopper 40. Before being inserted into the sleeve 3, the temperature sensor 20 is mounted on the closure cap 30 in a manner to insert the operating portion 21 into the hole 45 of the circular plate 41 and then to force the length portions 22 and 23 to be supported in the supporting portions 47.
  • the annular portions 34 and 35 are passed through the hole 45 and positioned around the inner circumference of the hole 45.
  • the wall portion 31 is positioned on the circumference of the rubber bung 2 adjacent the inner portion of the cylindrical portion 16.
  • the circumferential portion 32 is positioned directly and adjacently below the extending portion 17.
  • the assembly forces the annular portions 34 and 35 and the stopper 40 to be projected out of the hole 45 to form a hollow portion 26 between the temperature sensor 20 and the upper surface of the rubber bung 2 due to the height of the wall portion 31.
  • the hollow portion 26 allows the movement of the length portions 22 and 23 according to the operating of the operating portion 21 of the temperature sensor 20.
  • the free end of the sleeve 3 is bent inward against the rim portion 11 by a predetermined clamping tool to assure a secure seal of the medicament bottle 1.
  • the closure cap apparatus is a combining configuration of the closure cap 30 and the sleeve 3.
  • the medicament bottle 1 containing medicaments or medicine products is coupled with the closure cap apparatus with the length portions 22 and 23 being kept in a horizontal state as shown in Fig. 3 to complete the vial 10. Thereafter, the vial 10 is stored at a proper storage temperature, for example below a critical temperature.
  • the temperature sensor 20 has a second shape at below a critical temperature, so that the operating portion 21 is widened at the lower ends, the length portions 22 and 23 are moved upward at their ends and the circular plate 41 is moved upward at both sides by reference of the folding portions 44 as shown in Fig. 5. At the same time, the flaps 42 are moved upward to be spaced away beyond the upper surface of the annular portions 34 and 35. Therefore, as shown in Fig. 8, it allows a user to remove the stopper 40 from the closure cap 30 using his thumb and indexing finger. With the removal of the stopper 40 from the closure cap 30, the upper surface of the rubber bung 2 is exposed to enable the withdrawal of an injection medicament by a hypodermic injector. Of course, it means the safety storage of medicaments and the prevention of the bad influence of medicaments.
  • the temperature sensor has a first shape at below a critical temperature, so that the operating portion 21 is narrowed at the lower ends, the length portions 22 and 23 are moved downward at their ends and the circular plate 41 is moved downward at both sides by reference of the folding portions 44 as shown in Fig. 6.
  • the flaps 42 are moved downward to force its ends to be positioned adjacent the hole 18 of the sleeve-extending portion 17. Therefore, it makes it difficult to remove the stopper 40 from the closure cap 30. Of course, it means the wrong storage of medicaments or the exposure to over the critical temperature and leads to avoid the bad influence of medicaments.
  • a temperature sensor 20 is formed as an 0-ring type, the diameter of which is changed to be contracted into an oval at below a critical temperature and, on the contrary, to be expanded into a fixing circle at over a critical temperature.
  • a closure cap 30 adapted to the temperature sensor 20 is constructed so that an annular portion 50 has the function of a stopper as shown in Figs. 9 and 10.
  • the closure cap apparatus is a sealing configuration cooperating with the temperature sensor 20, which comprises the closure cap 30 and a sleeve 3 receiving the closure cap 30 therein.
  • the sleeve 3 has a configuration adapted to the first embodiment as described above, its detailed explanation being omitted.
  • the closure cap 30 comprises a receiving 33 provided with a tubular wall portion 31 formed as body and an upper surface 31' covered over the tubular wall portion 31; and an annular portion 50 functioning as a stopper.
  • the annular portion 50 includes a mounting portion 51 integrally projected from the circumference of a predetermined diameter on the upper surface 31' of the receiving portion 33 and then horizontally extended in a predetermined width therefrom with the front surface being opened, flaps 52 extended outward on the diameter line to prevent the removal of the temperature sensor 20 from the mounting portion 51 and a cutting line 53 formed on the upper surface around the outer circumference of the mounting portion 51.
  • the closure cap apparatus is assembled in a manner to mount the closure cap 30 in the sleeve 3 and then attach the sleeve 3 to the medicament bottle 1 as described above.
  • the temperature sensor 20 is made into a first shape of a fixing circle at over a critical temperature.
  • the vial 10 containing a medicament is stored at a predetermined temperature, for example a critical temperature, and the temperature sensor 20 is contracted and changed into a second shape of an oval to position in the space of the mounting portion 51 as shown in Fig. 11.
  • the medicament contained in the vial 10 is under the safety storage.
  • the annular portion 50 is removed from the closure cap 30 by pulling the flaps 52 grasped by the thumb and index finger.
  • the upper surface of the rubber bung 2 is exposed to allow the withdrawal of an injection medicament by a hypodermic injector.
  • it means the safety storage of medicaments and the prevention of the bad influence of medicaments.
  • the temperature sensor 20 is expanded and changed into a fixing circle to position directly below the flaps 12. In this case, it is difficult to remove the annular portion 50 from the closure cap 30, using the flaps 52 for not allowing the insertion of the finger into its open space.
  • a closure cap apparatus enables the easy identification of the safety storage of medicaments or medicine products and the detection of the damage degree of the medicaments through naked eyes instead of the difficulty in removing a closure cap from a medicament bottle 1.
  • the closure cap apparatus is as follows:
  • the closure cap apparatus comprises a closure cap 100 and a sleeve 3 coupled with each other.
  • the closure cap 100 is opened at the lower surface to be fitted into or compressed into the sleeve 3.
  • the closure cap 100 further includes a separate plastic partition (not shown) and a double-faced adhesive member to be adhered closely to or attached on the rubber bung of the vial 10, simply. With it, the closure cap 100 can be attached on the upper surface of a container such as a can, a plastic box, a vinyl package, etc. for the use purpose.
  • the closure cap 100 is a cylindrical body which comprises ribs 104 and 105 projected a little in a concentric circle from the upper surface thereof to enable the easy identification through naked eyes, first and second identification holes 101 and 102 diametrically formed in a constant interval to each another on each of the ribs 104 and 105 and a plurality of through-holes 103 passing a plurality of push buttons 121 which are projected from the upper portion of an oval operating control member 120 as described in detail below.
  • the closure cap 100 comprises the temperature sensor 20 made of a shape memory alloy which has a second shape of an oval at below a critical temperature and is expanded into a first shape of a fixing circle at over the critical temperature; an operating control portion 120 formed as an oval similar to the temperature sensor 20, which includes a guide plate 121 formed to cross the narrow diameter of the operating control portion 120 with a predetermining thickness, a plurality of push buttons 122 integrally projected from the upper surface thereby and respectively inserted into through- holes 103 corresponding to each another; and first and second moving indication members 130 and 130' separated from each other and including first and second moving members 131 and 132 arranged on the lower surface of the operating control member 120 surrounding the temperature sensor 20, in which each of the first and second moving members 131 and 132 is provided with rectangular indication bars 133 and 134 projected therefrom.
  • the temperature sensor 20 made of a shape memory alloy which has a second shape of an oval at below a critical temperature and is expanded into a first shape of a fixing circle at over the critical temperature
  • an operating control portion 120 formed
  • FIG. 12B another example of a moving indication member 140 can be used instead of the moving indication members 130 and 130'.
  • the moving indication member 140 is shown alone, but actually two moving indication members are used to be mounted on both sides of the diameter line of the temperature sensor 20.
  • the moving indication member 140 includes a body 141 made into a U-characterized shape to permit the temperature sensor 20 to be fitted thereinto, one side portion of which is projected upward to form an indication portion 142, and an extending portion 143 extended from the other side surface of the body 141.
  • the body 141 is positioned in a guide groove 112, which is formed on the upper inner surface.
  • the extending portion 143 is slidably inserted into a slit of a guide shaft 112 (described below) to move according to the changing of the temperature sensor 20.
  • the temperature sensor 20 may have its own inherent color. More preferably, it may be painted by a predetermined color such as a blue, red, etc.
  • the moving indication members 130, 130' and 142 are also processed using a plastic material having a predetermined color to identify it through naked eyes, easily.
  • the closure cap 100 includes the-ribs 104 and 105 formed on the upper surface thereof to facilitate the identification through naked eyes, an oval portion 107 formed on the center area to have the same height as those of the ribs 104 and 105, around the circumference of which six through holes 103 are formed in an interval away from each another and a projecting portion formed at the center area, which is used as a jaw at the time of being processed. Also, arrow indicating portions 109 and 109' are projected on both sides of the oval portion 107 to be directed contrary to each other to indicate the operating direction of the temperature sensor 20.
  • the first and second identification holes 101 and 102 are perforated on places to be directed by the arrow indicating portions 109 and 109'.
  • the identification holes 101 are formed at a place crossing the rib 104 on the diameter line and the identification holes 102 is formed at a place crossing the rib 105. Therefore, the first and second identification holes 101 and 102 are positioned at different places from the upper center of the closure cap 100 to indicate the exposure of the temperature sensor 20, for example medicaments, to over a critical temperature or the wrong storage of the medicaments. If the first moving indication member 130 is identified through the identification hole 101, a user can judge through the first identification hole 101 whether the deteriorating of the medicament state contained in the medicament bottle 2 reached the danger state. Furthermore, if the second moving indication member 130' is identified through the identification hole 102, the user can identify that the use of the medicament contained in the medicament bottle 2 is forbidden through the first identification hole 101.
  • the closure cap 100 comprises the temperature sensor 20, the operating control portion 120 and the first and second moving indication members 130 and 130' in order to
  • the closure cap 100 includes a guide shaft 110 integrally projected from the upper inner center thereof.
  • the guide shaft 110 includes a guide slit 111 formed in a direction perpendicular to a phantom line P to guide the up and down movement of the operating control member 120 and functions as a supporter.
  • a guide groove 112 is formed on the upper inner surface of the closure cap 100 to guide the straight movement of the first and second moving indication members 130 and 130' in the same direction as that of the slit 111.
  • At least one pair of first supporting walls 113 and 113'.. are formed in a symmetric with respect to the photom lines P-P to provide a first space 114 in which the operating control portion 120 is seated in a manner to insert the guide plate 121 into the slit 111.
  • the guide plate 121 is projected downward from the slit 111 and more projected downward therefrom when the push button 103 is pushed.
  • the first supporting walls 113, 113' has a height equal to a value of an oval thickness of the operating control member 120 plus the diameter of the temperature sensor 20. Therefore, the first supporting walls 113, 113'.. function to restrain the variation of the temperature sensor 20 positioned in the inner of the first space 114.
  • At least one pair of second supporting walls 115, 115'.. are integrally projected from the upper inner surface of the closure cap 100 to provide a second space 116 in which the first and second moving indication members 130 are 130' are seated outside the first supporting walls 113 and 113'.
  • the second supporting walls 115, 115'.. support the crescentic bodies 131 and 132 of the moving indication members 130 and 130' to be straightly moved in the guide groove 112.
  • the closure cap apparatus permits the operating control member 120 to be slidably fitted into the slit 11 of the guide shaft 110 which is formed at the upper inner center of the closure cap 100.
  • the push buttons 122 are inserted into the through holes 103 of the closure cap 100, the ends of which is projected out of the upper surface of the closure cap 100.
  • the temperature sensor 20 of an oval shape is seated in the first space 114 between the first supporting walls 113 and 113' and the guide plate 121.
  • the first and second moving indication members 130 and 130' are tightly seated in the guide groove 112 on the second space 114 inside the second supporting walls 115 and 115' to be slidably moved.
  • the rectangular indication bars 133 and 134 are arranged toward the upper portion of the closure cap 100 on which the identification holes 102 and 103 are formed on the concentric circles at distances different from each other from the center. Thereafter, the upper portion of the sleeve 3 is inserted into the opening portion of the closure cap 100, or the opening portion of the closure cap 100 is closed by a plastic partition (not shown).
  • the closure cap 100 is pressed/attached on the upper portion of the sleeve 3 to seal the medicament bottle 1.
  • the push buttons 122 are pressed.
  • the operating control member 120 integrated with the push buttons 120 is moved downward to force the temperature sensor 20 to be escaped from the restraint of the first supporting walls 115 and 115'.
  • the temperature sensor 20 is free of the first supporting walls 115 and 115' while positioned adjacent the inner circumferences of the moving indication members 130 and 130'.
  • the temperature sensor 20 having an oval shape is stretched into almost the first shape of an 0-ring type to force the first and second moving indication members 130 and 130' to be moved outward.
  • the rectangular indication bar 133 of the first moving indication member 130 is positioned directly below the first identification hole 101
  • the rectangular indication bar 134 of the second moving indication member 130' is positioned below a predetermined position of the upper inner surface of the closure cap 100 with being covered. Therefore, the rectangular indication bar 133 is identified through the first identification hole 101 by naked eyes. It enables a user to judge whether the product contained in the medicament bottle 1 is in a dangerous state. (Fig. 14C)
  • the temperature sensor 20 having an oval shape is stretched into the first shape of an 0-ring type to force the first and second moving indication members 130 and 130' to be further moved outward.
  • the rectangular indication bar 133 of the first moving indication member 130 is positioned below a predetermined position of the upper inner surface of the closure cap 100 with being covered, and the rectangular indication bar 134 of the second moving indication member 130' is positioned directly below the first identification hole 101. Therefore, the rectangular indication bar 134 is identified through the second identification hole 102 by naked eyes. It enables a user to judge whether the product contained in the medicament bottle 1 is gone bad. (Fig. 14D)
  • a closure cap 100 may include a plurality of identification holes A, B, C, D and A', B', C, D' formed on the upper surface thereof except for the identification holes 101 and 102. And, the closure cap 100 has the same configuration as that of this embodiment except for the number of the identification hole. Therefore, the closure cap 100 allows a user to identify the storage state according to medicine products or other products contained in a medicament bottle 1 in a step of a quality through naked eyes. These identification holes are kept in a certain interval from the center between their concentric circumferences and can be given a printing such as a numerical value, character, indication, etc. to approximate areas thereof. EMBODIMENT 3
  • a closure cap apparatus comprises a closure cap 200 to be constituted as a simple configuration for enabling a safety storage state of medicine products contained in a medicament bottle 1.
  • the closure cap apparatus is adapted to a vial 10 including a bottle 1 containing injection medicine, medicine products or medicament, etc., a rubber bung 2 sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve 3 fitted onto the upper mouth of the bottle above the rubber bung.
  • the closure cap 200 is coupled with the sleeve 3 in a manner to be fitted or pressed onto the upper of the sleeve 3 through its opened lower portion.
  • the closure cap apparatus including a cylindrical body comprises a housing 201 projected in a predetermined width from a certain surface of the upper surface between the center and the circumference thereof, at least one identification hole formed on the housing 201 to permit the deteriorating of the medicament or the exposure of the medicament in the medicament bottle 1 to over a critical temperature to be identified through naked eyes and a projecting portion 203 projected from the center for functioning as a supporting jaw at the time of the pressing process thereof.
  • the closure cap 200 comprises a temperature sensor 20 made of a shape memory alloy and a temperature sensor 20 having a second shape of an oval at below a critical temperature of a circle and a first shape at over a critical temperature and a C-shaped moving indication member 210 including a groove portion 211 formed to fit a part of the temperature sensor thereinto.
  • the housing 210 and the moving indication member 210 are shown by one in the drawing, but can be mounted by two on both sides of the diameter line of the temperature sensor 20.
  • the moving indication member 210 can be painted by a color on the whole or only on a part exposed through the identification hole 212 for the easy identification.
  • the temperature sensor 20 and the moving indication member 210 are mounted in the closure cap 20 as follows:
  • the closure cap 200 comprises a center shaft 201 integrally projected from the upper inner center thereof, receiving wall portions 204 and 205 respectively formed downward corresponding to both walls of the housing 201 by the reference of the center shaft 201 to slidably position the moving indication member 210 between the receiving wall portions 204 and 205, first supporting walls 206 and 207 projected downward in an arc adjacent to the wall portion thereof, second supporting walls 208 projected downward in an arc adjacent to the wall portion thereof to be faced against the first supporting walls 206 and 207 and approximate wall portions 209 projected downward to form a space for positioning an arc portion of the temperature sensor 20 in part in a hollow portion formed by the second wall portions 208 and the approximate wall portions 209.
  • the arc portion of the temperature sensor 20 is inserted into the space between the second wall portion 208 and the approximate wall portion 209.
  • the other arc portion is arranged on a space formed by the first walls 206 and 207.
  • the closure cap 200 receives the upper portion of the sleeve 3 from the opening potion thereof or is closed by a plastic partition (not shown).
  • the closure cap 200 is pressed up to and fixed on the sleeve 3 to seal the medicament bottle 1.
  • the temperature sensor 20 is mounted in the closure cap 200 to have a first shape of a circle or a second shape of an oval to force the moving indication member 210 to be identified through the indication hole 202, and vice versa.
  • the temperature sensor 20 is returned to its shape, for example the second shape of an oval to position the moving indication member 210 in the housing 201 on the upper portion of the closure cap 200, so that the moving indication member 210 is not exposed to an outside. Therefore, the moving indication member 210 enables a user to judge whether the product in the medicament bottle 1 is normal. (Fig. 18A)
  • the temperature sensor 20 is stretched into the first shape of a circle to force the moving indication member 210 to be moved outward, strongly.
  • the moving indication member 210 is slidably moved in the housing 201 to position directly below the identification hole 202 on the upper portion of the closure cap 200. Therefore, the moving indication member 210 enables the user to identify its color through naked eyes and to judge whether the product in the medicament bottle 1 is abnormal. (Fig. 18B). Also, the identification hole is replaced with the upper portion of the housing 201 to permit the storage state of the product in the medicament bottle 1 to be more closely examined through naked eyes.
  • a closure cap apparatus comprises a closure cap in which a temperature sensor is mounted in a predetermined arrangement, so that the closure cap is easily removed from a vial according to the storage state of the vial, otherwise its removal becomes hard.
  • the closure cap further comprises an operating control member and a moving indication member to enable the identification on a storage state of a product in a medicament bottle through naked eyes.
  • the closure cap includes a plurality of identification holes or an elongated hole to enable the moving indication member to identify the storage state of the product in steps through naked eyes according to the kinds of the product or medicament. Therefore, the invention has advantages in that the storage product is checked directly before being damaged, so that its discard is prevented in advance and it enable the effective management of products for a user.

Abstract

A closure cap apparatus using a shape memory alloy is adapted to a vial including a bottle (1) containing injection medicine, medicine products or medicaments, etc., a rubber bung (2) sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve fitted onto the upper mouth of the bottle above the rubber bung (2). The closure cap apparatus comprises a sleeve (3) including a cylindrical portion (16) surrounding a rim portion (12) of the medicament bottle (1) and a tubular wall portion (31) of a closure cap (30), an extending portion horizontally extended in a predetermined length from the cylindrical portion (16), a hole formed at the center thereof and a free end bent inward from the circumference in contact with the lower edge of the rim portion (12) by a predetermined clamping tool; a temperature sensor positioned on the lower surface to have a second shape at below a critical temperature and a first shape at above a critical temperature; and a closure cap (30) easily removed from a vial according to the storage state of the vial, otherwise its removal becomes hard, and includes an operating control member and a moving indication member to enable the identification on a storage state of a product in the medicament bottle through naked eyes.

Description

CLOSURE CAP APPARATUS FOR MEDICAMENT BOTTLE USING SHAPE MEMORY ALLOY
Background of the Invention
The invention is related to a cap for a medicament bottle, and particularly, to a closure cap apparatus for medicament bottle or vial to be stored under the freezing or refrigerating condition using a shape memory ally.
More concretely, the invention is related to providing a closure cap apparatus for medicament bottles or vials, with which a shape memory alloy having first and second shapes changed according to the surroundings temperature is provided, in which the shape memory alloy is kept at the second shape to permit the medicament stored in the bottle to be used during the freezing or refrigerating storage at a proper temperature and, on the contrary, changed into the first shape to enable the use of the medicament to be prohibited with anxiety of its damage, if it is exposed to a room temperature or over a critical temperature for a long time, even temporarily.
Prior Art
In general, it is known that a conventional metal material keeps the deformed shape after being plastic deformed over the limitation of its elastic coefficient. On contrary, a shape memory alloy (called "SMA" below) has its own inherent property to return to its original shape, when the deformation cause disappears, or the deformed SMA is heat-processed at above its transformation temperature after the plastic deformation at a yield point. There are alloys of a Ti-Ni type, Cu type, a Fe type, etc. which are known by studies of their properties of Martensitic deformation and the shape memory and their crystal structures at a lower or higher temperature. Therefore, the SMA is now used in various fields. Particularly, the SMA is heat-treated to be used as a specific element or to have a specific shape for a predetermined purpose of a shape memory related to a temperature.
In these respects, the SMA has been applied to a functional device provided in an actuator, etc. in a higher precision part and a temperature sensor, and also has been used as a fixing part that is simply fixed to a product in the form of a plate, a wire, etc. for indicating a temperature by being returned to its own inherent shape beyond a predetermined deformation temperature. In other words, the fixing part has been used in easily identifying whether frozen products including frozen meats, etc., and cold storage foodstuffs including milk are exposed to a critical temperature during being processed or transported.
A typical technology of a temperature sensor using an SMA is disclosed in US Patent No. 5,735,607. The patent is related to shape memory alloy thaw sensors for providing persistent indication of the damage of food products such as frozen dairy products and frozen meats spoiled upon being exposed to thawing temperatures for even a short time and frozen medical products such as blood and certain pharmaceuticals unstable once exposed to thawing or other high temperatures, even if the temperature later returns to a safe value, which causes due to the improper handling or cooling equipment malfunction in transportation or during being processed, whereby the careless use of these products is prevented.
The SMA sensor changes a shape at its Austenitic temperature, and will not return to its original shape in the Martensitic phase if the temperature returns to the original value. In other words, the SMA sensor at least one member having a first shape at temperatures below a critical temperature and a second shape at temperatures above the critical temperature, where each member assumes the second shape when the temperature rises above the critical temperature but does not return to the first shape when the temperature falls below the critical temperature; and a plurality of indicators mounted with the members, where the indicators obscure the indication surface when the members are in the first shape, and where the indicators do not obscure the indication surface when the members are in their second shape.
However, the patent further comprises a structure for preventing the shape memory alloy member from being returned to the first shape after being made into the second shape according to its changing property, which makes the total configuration of the thaw sensor complex. Also, the thaw sensor is not forced to use the change of the inherent shape of the shape memory alloy. Therefore, this thaw sensor has disadvantages in that it is expensive and available only for a specific product, not for a general cheaper product. Further, the use of the thaw sensor must be accompanied with a cumbersome process of properly attaching the base to the product in advance for mounting the thaw sensor thereon. In order to confirm the operation of the thaw sensor, the state of an indicator on the base must be carefully checked.
Furthermore, there has never been disclosed any technology that the damage of the medicament in bottles, vials or containers is determined by a cap or makes it difficult to remove the cap from the corresponding bottle, nevertheless a shape memory alloy could be adapted to the cap which is a part except for the side surface of the bottle or vial in order to identify the possibility of the medicament damage.
In other words, referring to Fig. 1, a conventional medicine container or injection medicine vial 10 is shown. The vial 10 includes a bottle 1 for storing injection medicine, a bung 2 clogged in an upper mouth of the bottle and made of an antibiotics or an aseptic material, a sleeve made of a silver and an aluminium and for preventing the removal of the bung 2 from the bottle 1 and a cap 4 covered on the bung 2 and made of a plastic and an aluminium. Therefore, when the vial 10 is assembled, an amount of injection medicine is filled into the bottle 1. The bung 2 is plugged into the mouth of the bottle 1. The sleeve 3 is partly covered onto the bung 2 and pressed around the peripheral of the bottle mouth to be not removed therefrom. The cap 4 is fixed onto the sleeve 3. The vial 10 includes a general closure configuration independent of the peripheral temperature, which makes it impossible to discriminate its storage state. For it, if the vial containing medicaments is stored for a long period at a normal temperature or above a critical temperature, it is anxious that the medicament could go bad or be deteriorating.
In light of these points, in order not to use the deteriorating medicine, there has been well known a passive measure of identifying the use of the vial so that the medicine products contained in already-used-container or vial are no longer used. For example, there are many technologies related to a cap structure of a bottle or container containing a medicine product. A typical technology is disclosed in US Patent No. 555988, which is related to a closure with a tamper-indicating cap for injection and infusion bottles. The closure includes a holding part for seal and a cap with a downwardly extending edge arranged between the holding part and the seal. The closure has the indicating function to permit its use to be identified through naked eyes except its inherent sealing function. Namely, the holding part of the closure includes a recess in which the tamper-indicating cap is arranged in a positive-locking manner. Therefore, the removal of the cap from the bottle permits the use of the medicine product to be identified.
The closure also is supposed to be not able to determine through naked eyes whether the medicine product in the bottle is normal resulting from the freezing or refrigerating storage at below a critical temperature or deteriorates due to the exposure to a normal temperature or above the critical temperature. And, the invention fails to suggest any protective measure against the deterioration of the medicine product.
Furthermore, such like cap closure containing the medicine product has disadvantages in that it is inconvenient to identify the change of the cap in order to discriminate the spoilage of the medicine product. Also, it is difficult to determine whether the medicine product is stored under a normal state or wrongly stored at above the critical temperature due to an accident influencing on the bottle or vial thereby to go bad.
Therefore, in order to prevent the accident of causing the bad effect on a patient or a person to be inoculated against epidemics in advance due to the wrong use of the medicine deteriorated at below the critical temperature, it is preferable to be easily able to recognize the exposure of the medicine to the surrounding temperature or over the critical temperature.
Accordingly, an object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament for enabling the medicament to be stored in the freezing or refrigerating condition to determine whether it is normal or deteriorates using a shape memory alloy.
Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy which is kept at a second shape under the freezing or refrigerating storage of medicine products or medicaments at below a critical temperature to allow the use of the medicament and, on the contrary, changed into a first shape to enable the use of the medicament to be prohibited with anxiety of its damage, if it is exposed to a room temperature or over a critical temperature for a long time, even temporarily.
Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy which is kept at a second shape to permit the removal of the closure cap apparatus from the vials at below a critical temperature and, on the contrary, to be changed into a first shape to prevent the removal of the closure cap apparatus from the vials at above the critical temperature.
Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy, which includes a closure cap control means to be kept at a second shape for permitting the removal of the closure cap apparatus from the vials at below a critical temperature and, on the contrary, changed into a first shape in order to prevent the removal of the closure cap apparatus from the vials at above the critical temperature.
Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy which is kept at a second shape to indicate the normal state of the medicament on the closure cap apparatus at below a critical temperature and, on the contrary, changed into a first shape to indicate the abnormal state of the medicament or a warning for the use prohibition on the closure cap apparatus at above the critical temperature.
Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy, which includes an indicating means to be kept at a second shape at below a critical temperature and, on the contrary, to be changed into a first shape in order to indicate the damage of the medicament at above the critical temperature.
Another object of the invention is to provide a closure cap apparatus for bottles or vials containing medicine products or medicament using a shape memory alloy, which includes means for preventing the malfunction of the shape memory alloy that is kept at a second shape at below a critical temperature and changed into a first shape at above the critical temperature, setting the storage state of the medicament and indicating whether the medicament is damaged or not.
SUMMARY OF THE INVENTION According to a first embodiment of the invention, a closure cap apparatus using a shape memory alloy is adapted to a vial including a bottle containing injection medicine, medicine products or medicaments, etc., a rubber bung sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve fitted onto the upper mouth of the bottle above the rubber bung.
The closure cap apparatus comprises a sleeve including a cylindrical portion surrounding a rim portion of the medicament bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact with the lower edge of the rim portion by a predetermined clamping tool; a closure cap of a two stories structure, which is made of a plastic or synthetic resin, including a receiving portion positioned in the sleeve, two annular portions of a crescentic shape integrally projected from the receiving portion to be arranged against each other and a stopper including flaps formed upright on the diameter line of the closure cap between the two annular portions to control the removal of the closure cap from the vial and a circular plate integrated with the flaps and connected on the diameter line to the inner lower portion of the annular portions; and a temperature sensor positioned on the lower surface to have a second shape at below a critical temperature and a first shape at above a critical temperature so as to control the operating of the flaps.
The stopper includes the circular plate positioned around the inner lower circumference of the annular portion and flaps extended from the circular plate in the form of the inner and upper walls of the annular portion and between both ends of the annular portions, in which the circular plate includes a folding portion having a predetermined width formed on both sides by reference of a scoring line of a diameter thereof, a hole formed at the center to insert an operating portion of the temperature sensor for the folding portion and connecting portions formed at both ends to be fixed to the inner lower circumference of the annular portion. According to another example of this another embodiment, a closure cap apparatus comprises a sleeve including a cylindrical portion surrounding a rim portion of the bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact with the lower edge of the rim portion by a predetermined clamping tool; a closure cap of a two stories structure including a receiving portion provided with a cylindrical wall for forming a cylindrical body and an upper surface positioned in the sleeve, annular portions provided with a mounting portion integrally projected from a circumferential arc of a predetermined diameter on the upper surface of the receiving portion and then horizontally extended in a predetermined width therefrom with the front surface being opened, flaps extended outward from both sides of the diameter line to prevent the removal of a temperature sensor from the mounting portion and a cutting line formed on the upper surface around the outer circumference of the mounting portion; and the temperature sensor of an O ring type changed in its diameter to have a second shape of an oval at below a critical temperature and a first shape of a regular circle at above a critical temperature so as to control the operating of the flaps.
The temperature sensor is positioned in the mounting portion to surround the circumferential wall of the mounting portion which is kept at the second shape of an oval at below a critical temperature to allow the removal thereof from the annular portion and expanded into the first shape of a circle at above the critical temperature to prevent the removal thereof from the annular portion.
According to a second embodiment of the invention, a closure cap apparatus is adapted to a vial including a bottle containing injection medicine, medicine products or medicament, etc., a rubber bung sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve fitted onto the upper mouth of the bottle above the rubber bung.
The closure cap apparatus comprises a sleeve including a cylindrical portion surrounding a rim portion of the bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact with the lower edge of the rim portion by a predetermined clamping tool; a temperature sensor of an O ring type changed in its diameter to have a second shape of an oval at below a critical temperature and a first shape of a circle at over a critical temperature; and a closure cap including an operating control member provided with a thickness portion of an oval similar to the temperature sensor, a guide plate formed on both sides of the narrow diameter line thereof and a plurality of push buttons projected from the upper surface to be inserted into a plurality of through-holes formed on tlie upper surface thereof to correspond to each another and at least one moving indication member arranged on the lower surface of the operating control member to surround the temperature sensor and including a moving member with a rectangular indication bar projected therefrom.
The closure cap comprises a plurality of ribs projected a little from the upper surface to facilitate the identification thereof through naked eyes, at least two identification holes formed at places different from each another on the upper surface to permit the storage stage of a product in the medicament bottle to be identified, a plurality of through-holes formed in a concentric circle interval spaced form each another on the upper surface to be coupled with the corresponding push button of the moving indication members, a projecting portion formed at a center area to be used as a supporting jaw in the course of the press processing at the time of being assembled with the bottle, an oval portion formed at the center area and arrow portions formed on both sides of the oval portion to indicate the direction that the operating control portion is moved.
Also, the closure cap comprises a guide shaft integrally projected from the upper inner center and including a guide slit formed in a direction to guide the up and down movement of the operating control member, a guide groove formed on the upper inner surface to guide the straight movement of the moving indication members in the same direction as that of the slit, at least one pair of first supporting walls formed in a symmetric with respect to each another to provides oval hollow portions for the moving indication members and at least one pair of second supporting walls integrally projected from the upper inner surface to provide hollow portions for the moving indication members.
The operating control member includes a plurality of push buttons to be inserted into the corresponding button hole of the closure cap and a guide plate integrated therewith to be slidably moved in the slit of the center shaft on the upper inner surface of the closure cap.
The moving indication members include a crescentic body having a predetermined limited length and an indicating bar projected in a predetermined length from the upper center portion of the crescent body.
It is preferably that a lower opening portion of the closure cap includes a separate plastic partition and adhesives applied thereon to fix the closure cap on the upper surface of the rubber bung or attach the closure cap to an upper portion of a container such as a vinyl package, etc.
According to another example of this embodiment, at least two moving indication members are positioned in a guide groove portion separated from each another and include an U-characterized body formed to force the temperature sensor to be fitted thereinto, one side of which is projected to function as an indicating portion, and other side of which is extended to position its free end in the slit of the guide shaft.
It is preferable that the moving indication member is made of a plastic processing material having any colour to facilitate the identification thereof through naked eyes.
Also, it is preferable that a numerical value, character or indication is provided on the periphery of the identification holes.
According to a third embodiment of the invention, a closure cap apparatus is adapted to a vial including a bottle containing injection medicine, medicine products or medicament, etc., a rubber bung sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve fitted onto the upper mouth of the bottle above the rubber bung.
The closure cap apparatus comprises a sleeve including a cylindrical portion surrounding a rim portion of the bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact, with the lower edge of the rim portion by a predetermined clamping tool; a temperature sensor changed at its diameter to have a second shape of an oval at below a critical temperature and a first shape of a regular circle at above a critical temperature; and a closure cap including a housing projected in a predetermined width from the upper surface from the center close to the circumference thereof, at least one identification hole formed on the housing to permit the storage state or the exposure of the medicament to over a critical temperature to be identified through naked eyes, a C-shaped moving indication member including a groove portion formed to fit one arc portion of the temperature sensor thereinto and a projecting portion projected from the center to be used as a supporting jaw in the time of its press processing for the assembly with the bottle. The closure cap comprises a center shaft integrally projected from the upper inner center thereof, receiving wall portions formed downward corresponding to both side walls of the housing by the reference of the center shaft to slidably receive the moving indication member between the receiving wall portions, first supporting walls projected downward in an arc adjacent to the wall portion thereof, second supporting walls projected downward in an arc adjacent to the wall portion thereof to be faced against the first supporting walls and approximate wall portions projected downward to form a space for positioning an arc portion of the temperature sensor in part in a hollow portion formed by the second wall portions and the approximate wall portions.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention now will be described in detail with reference to the accompanying drawings, in which:
Fig. 1 is a separate perspective view illustrating a configuration that a cap is adapted to a vial according to a prior art;
Fig. 2 is a separate perspective view illustrating a configuration that a closure cap apparatus is adapted to a medicament bottle according to a first embodiment of the invention;
Fig. 3 is a cross-sectional perspective view illustrating the state that a closure cap apparatus is partly cut out;
Fig. 4 is a rear perspective view illustrating the assembly of a temperature sensor and a stopper into the closure cap apparatus according to the first embodiment of the invention;
Fig. 5 is a cross-sectional perspective view illustrating the operating of the stopper according to the first embodiment of the invention, when the temperature sensor is made into a second shape at below a critical temperature;
Fig. 6 is a cross-sectional perspective view illustrating the operating of the stopper according to the first embodiment of the invention, when the temperature sensor is made into a first shape at below the critical temperature;
Fig. 7 is a perspective view illustrating the use state of the closure cap apparatus mounted in the bottle according to the first embodiment of the invention;
Fig. 8 is a perspective view illustrating the removal of the stopper from the closure cap apparatus according to the first embodiment of the invention;
Fig. 9 is a perspective view illustrating a closure cap partly cut out according to another embodiment of the closure cap apparatus;
Fig. 10 is a top view illustrating the upper surface of the closure cap according to another embodiment of the closure cap apparatus;
Fig. 11 is a cross-sectional view illustrating the operating of the temperature sensor mounted on the closure cap according to another embodiment of the closure cap apparatus;
Fig. 12A is an exploded perspective view illustrating a closure cap apparatus according to a second embodiment of the invention;
Fig. 12B is a perspective view illustrating another example of a moving indication member mounted in the closure cap apparatus according to the second embodiment of the invention;
Fig. 13 is a rear perspective view illustrating the configuration of the closure cap according to the second embodiment of the invention;
Fig. 14A is a cross-sectional view illustrating the assembly of an operating control member, a temperature sensor and a moving indication member into the closure cap apparatus and their operating according to the second embodiment of the invention;
Fig. 14B is a cross-sectional view illustrating the initial operating state of the closure cap apparatus related to a second shape of the temperature sensor according to the second embodiment of the invention: Fig. 14C is a cross-sectional view illustrating the operating state of the closure cap apparatus at the time of being partly changed into a first shape of the temperature sensor according to the second embodiment of the invention;
Fig. 14D is a cross-sectional view illustrating the operating state of the closure cap apparatus at the time of being fully changed into the first shape of the temperature sensor according to the second embodiment of the invention;
Fig. 15 is a front perspective view illustrating a closure cap according to another example of the second embodiment;
Fig. 16 is a perspective view illustrating a closure cap apparatus according to a third embodiment of the invention;
Fig. 17 is a rear perspective view illustrating the assembly of a temperature sensor and a moving indication member into the closure cap apparatus according to the third embodiment of the invention;
Fig. 18A is a perspective view illustrating the closure cap apparatus, on which the moving indication member cannot be identified during the normal storage of a freezing or refrigerating product; and,
Fig. 18B is a perspective view illustrating the closure cap apparatus, on which the moving indication member can be identified during the abnormal storage of a freezing or refrigerating product.
DETAILED DESCRIPTION OF THE INVENTION Referring to Figs. 2 and 11, a closure cap apparatus is mounted on a vial and operated according to a first embodiment of the invention. The closure cap apparatus is adapted to a bottle, container or vial 10 containing refined medicine products or medicaments of a solid or liquor such as a Vaccine, Penicillin, etc.
As shown in Fig. 2, a vial comprises a medicament bottle 1, a rubber bung 2 fitted into the mouth of the medicament bottle 1, a sleeve 3 for preventing the removal of the rubber bung 2 and a closure cap 30 covered on the sleeve 3.
According to the first embodiment of the invention, a closure cap apparatus comprises the sleeve 3 and the closure cap 30. The closure cap apparatus further comprises a temperature sensor 20 made of a shape memory alloy, which has a second shape at below a critical temperature and a first shape at above a critical temperature. The temperature sensor 20 prevents the separation or removal of the closure cap 30 from the vial 10 to control the use of a solid medicament or injection fluid contained in the medicament bottle 1. As described in detail below, the closure cap 30 is assembled into the sleeve 3 in advance and fixed on the rubber bung 2 at the same time to seal the medicament bottle 1.
As shown in Fig. 3, the medicament bottle 1 includes an open end 11, an annular rim portion 12 radially extended from the open end 11 and a neck portion 13 adjacent the rim portion 12. The open end 11 of the medicament bottle 1 is typically closed with an elastic rubber bung 2, which includes a tubular body portion 14 that is received in the open end 11 of the medicament bottle 1 and a planar flange portion 15, which overlies the rim portion 12 of the medicament bottle 1. The central portion of the rubber bung 2 is pierced with a hypodermic needle, for example, to either withdraw fluid from the vial 10 or add a solvent or diluent to the vial 10 where the medicament in the vial 10 is a dry or powder drug.
The sleeve 3 includes a cylindrical portion 16 which surrounds the rim portion 12 of the medicament bottle 1, a flange 15 of the rubber bung 2 and a tubular wall portion 31 of the closure cap 30 as described below. Also, the sleeve 3 includes an extending portion horizontally extended in a predetermined length from the cylindrical portion 16, a hole 18 formed at the center thereof and a free end portion 19 bent inward from around the circumference in contact with the lower edge of the rim portion by a predetermined tool.
The closure cap 30 is formed as an integral two stories structure made of a plastic or synthetic resin and includes a receiving portion 33 positioned in the sleeve 3, two annular portions 34 and 35 of a crescentic shape integrally projected from the receiving portion to be arranged against each other and a stopper 40 for controlling the separation or removal of the closure cap 30 from the vial 10, in which the stopper 40 includes flaps 42 formed upright on both sides of the diameter line of the closure cap 30 between the two annular portions 34 and 35 and a circular plate 41 integrated with the flaps 42 and connected at the diameter line to the inner lower portion of the annular portions 34 and 35. The receiving portion 33 includes a wall portion 31 positioned adjacent the inner surface of the cylindrical 16 and a circumferential portion 32 radially and horizontally extended inward in a predetermined length from the wall portion.
The stopper 40 includes the circular plate positioned around the inner lower circumference of the annular portions 34 and 35 and the flaps 42 each extended from the circular plate 41 to the spaces between both ends of the annular portions 34 and 35 in a form similar to the inner and upper walls of the annular portions 34 and 35.
More concretely, the rear surface of the stopper 40 is shown in Fig. 4. A folding portion 44 is formed on the circular plate 41 to have a predetermined width formed on both sides by reference of a scoring line 34 of a diameter line thereof. A hole 45 is formed at the center of the circular plate 41 to permit an operating portion 21 of the temperature sensor 20 to be inserted thereinto. A connecting portion 46 is integrally extended from ends of the folding portion 44 to connect the circular plate 41 to the inner lower circumferences of the annular portions 34 and 35. Supporting portion s 47 is formed on the circular plate 42 close to the folding portion 44 to wrap around the temperature sensor 20 for supporting.
The temperature sensor 20 is positioned on the lower surface of the circular plate 41 and includes the operating portion 21 formed at the center to have a second shape at below a critical temperature and a first shape at above a critical temperature and length portions 22 and 23 extended in a predetermined length from the operating portion 21, thereby controlling the operating of the flaps 42.
Herein, it is noted that the stopper 40 is integrally moulded with the closure cap 30 at the time of being manufactured. The connecting portions 46 are connected at the diameter line to the inner lower circumferences of the annular portions 34 and 35. Except it, the circular plate 41 and the flaps 42 are moulded into the closure cap 30 with being separated from the annular portions 34 and 35. Also, as not shown in Fig. 3, at least two bridges are formed on the side surfaces of the flaps 42. Therefore, the closure cap 30 is moulded to be integrated with the receiving portion 30, the annular portions 34 and 35 and the stopper 40. Before being inserted into the sleeve 3, the temperature sensor 20 is mounted on the closure cap 30 in a manner to insert the operating portion 21 into the hole 45 of the circular plate 41 and then to force the length portions 22 and 23 to be supported in the supporting portions 47.
When the closure cap 30 is inserted into the sleeve 3, the annular portions 34 and 35 are passed through the hole 45 and positioned around the inner circumference of the hole 45. The wall portion 31 is positioned on the circumference of the rubber bung 2 adjacent the inner portion of the cylindrical portion 16. The circumferential portion 32 is positioned directly and adjacently below the extending portion 17. The assembly forces the annular portions 34 and 35 and the stopper 40 to be projected out of the hole 45 to form a hollow portion 26 between the temperature sensor 20 and the upper surface of the rubber bung 2 due to the height of the wall portion 31. The hollow portion 26 allows the movement of the length portions 22 and 23 according to the operating of the operating portion 21 of the temperature sensor 20. Finally, the free end of the sleeve 3 is bent inward against the rim portion 11 by a predetermined clamping tool to assure a secure seal of the medicament bottle 1.
Therefore, it is noted that the closure cap apparatus is a combining configuration of the closure cap 30 and the sleeve 3. The medicament bottle 1 containing medicaments or medicine products is coupled with the closure cap apparatus with the length portions 22 and 23 being kept in a horizontal state as shown in Fig. 3 to complete the vial 10. Thereafter, the vial 10 is stored at a proper storage temperature, for example below a critical temperature.
The temperature sensor 20 has a second shape at below a critical temperature, so that the operating portion 21 is widened at the lower ends, the length portions 22 and 23 are moved upward at their ends and the circular plate 41 is moved upward at both sides by reference of the folding portions 44 as shown in Fig. 5. At the same time, the flaps 42 are moved upward to be spaced away beyond the upper surface of the annular portions 34 and 35. Therefore, as shown in Fig. 8, it allows a user to remove the stopper 40 from the closure cap 30 using his thumb and indexing finger. With the removal of the stopper 40 from the closure cap 30, the upper surface of the rubber bung 2 is exposed to enable the withdrawal of an injection medicament by a hypodermic injector. Of course, it means the safety storage of medicaments and the prevention of the bad influence of medicaments.
On the contrary, the temperature sensor has a first shape at below a critical temperature, so that the operating portion 21 is narrowed at the lower ends, the length portions 22 and 23 are moved downward at their ends and the circular plate 41 is moved downward at both sides by reference of the folding portions 44 as shown in Fig. 6. At the same time, the flaps 42 are moved downward to force its ends to be positioned adjacent the hole 18 of the sleeve-extending portion 17. Therefore, it makes it difficult to remove the stopper 40 from the closure cap 30. Of course, it means the wrong storage of medicaments or the exposure to over the critical temperature and leads to avoid the bad influence of medicaments.
On the other hand, referring to Fig. 9 to Fig. 11, another example of the first embodiment is illustrated. A temperature sensor 20 is formed as an 0-ring type, the diameter of which is changed to be contracted into an oval at below a critical temperature and, on the contrary, to be expanded into a fixing circle at over a critical temperature. A closure cap 30 adapted to the temperature sensor 20 is constructed so that an annular portion 50 has the function of a stopper as shown in Figs. 9 and 10.
The closure cap apparatus is a sealing configuration cooperating with the temperature sensor 20, which comprises the closure cap 30 and a sleeve 3 receiving the closure cap 30 therein. Herein, the sleeve 3 has a configuration adapted to the first embodiment as described above, its detailed explanation being omitted. The closure cap 30 comprises a receiving 33 provided with a tubular wall portion 31 formed as body and an upper surface 31' covered over the tubular wall portion 31; and an annular portion 50 functioning as a stopper. The annular portion 50 includes a mounting portion 51 integrally projected from the circumference of a predetermined diameter on the upper surface 31' of the receiving portion 33 and then horizontally extended in a predetermined width therefrom with the front surface being opened, flaps 52 extended outward on the diameter line to prevent the removal of the temperature sensor 20 from the mounting portion 51 and a cutting line 53 formed on the upper surface around the outer circumference of the mounting portion 51.
The closure cap apparatus is assembled in a manner to mount the closure cap 30 in the sleeve 3 and then attach the sleeve 3 to the medicament bottle 1 as described above. At the time of mounting on the mounting portion 51, the temperature sensor 20 is made into a first shape of a fixing circle at over a critical temperature. Thereafter, the vial 10 containing a medicament is stored at a predetermined temperature, for example a critical temperature, and the temperature sensor 20 is contracted and changed into a second shape of an oval to position in the space of the mounting portion 51 as shown in Fig. 11.
Therefore, it means that the medicament contained in the vial 10 is under the safety storage. For the use of the medicament, the annular portion 50 is removed from the closure cap 30 by pulling the flaps 52 grasped by the thumb and index finger. At this time, the upper surface of the rubber bung 2 is exposed to allow the withdrawal of an injection medicament by a hypodermic injector. Of course, it means the safety storage of medicaments and the prevention of the bad influence of medicaments.
On the contrary, if the medicament contained in the vial 10 is wrongly stored or exposed to over a critical temperature, the temperature sensor 20 is expanded and changed into a fixing circle to position directly below the flaps 12. In this case, it is difficult to remove the annular portion 50 from the closure cap 30, using the flaps 52 for not allowing the insertion of the finger into its open space.
EMBODIMENT 2
Referring to Figs. 12 and 15, a closure cap apparatus enables the easy identification of the safety storage of medicaments or medicine products and the detection of the damage degree of the medicaments through naked eyes instead of the difficulty in removing a closure cap from a medicament bottle 1. The closure cap apparatus is as follows:
As shown in Fig. 12 A, the closure cap apparatus comprises a closure cap 100 and a sleeve 3 coupled with each other. The closure cap 100 is opened at the lower surface to be fitted into or compressed into the sleeve 3. In order to assure a better seal of a vial 10, the closure cap 100 further includes a separate plastic partition (not shown) and a double-faced adhesive member to be adhered closely to or attached on the rubber bung of the vial 10, simply. With it, the closure cap 100 can be attached on the upper surface of a container such as a can, a plastic box, a vinyl package, etc. for the use purpose.
The closure cap 100 is a cylindrical body which comprises ribs 104 and 105 projected a little in a concentric circle from the upper surface thereof to enable the easy identification through naked eyes, first and second identification holes 101 and 102 diametrically formed in a constant interval to each another on each of the ribs 104 and 105 and a plurality of through-holes 103 passing a plurality of push buttons 121 which are projected from the upper portion of an oval operating control member 120 as described in detail below. Also, the closure cap 100 comprises the temperature sensor 20 made of a shape memory alloy which has a second shape of an oval at below a critical temperature and is expanded into a first shape of a fixing circle at over the critical temperature; an operating control portion 120 formed as an oval similar to the temperature sensor 20, which includes a guide plate 121 formed to cross the narrow diameter of the operating control portion 120 with a predetermining thickness, a plurality of push buttons 122 integrally projected from the upper surface thereby and respectively inserted into through- holes 103 corresponding to each another; and first and second moving indication members 130 and 130' separated from each other and including first and second moving members 131 and 132 arranged on the lower surface of the operating control member 120 surrounding the temperature sensor 20, in which each of the first and second moving members 131 and 132 is provided with rectangular indication bars 133 and 134 projected therefrom.
On the other hand, as shown in Fig. 12B, another example of a moving indication member 140 can be used instead of the moving indication members 130 and 130'. The moving indication member 140 is shown alone, but actually two moving indication members are used to be mounted on both sides of the diameter line of the temperature sensor 20. The moving indication member 140 includes a body 141 made into a U-characterized shape to permit the temperature sensor 20 to be fitted thereinto, one side portion of which is projected upward to form an indication portion 142, and an extending portion 143 extended from the other side surface of the body 141. The body 141 is positioned in a guide groove 112, which is formed on the upper inner surface. The extending portion 143 is slidably inserted into a slit of a guide shaft 112 (described below) to move according to the changing of the temperature sensor 20. Herein, the temperature sensor 20 may have its own inherent color. More preferably, it may be painted by a predetermined color such as a blue, red, etc. The moving indication members 130, 130' and 142 are also processed using a plastic material having a predetermined color to identify it through naked eyes, easily.
Returning to Fig. 12A, the closure cap 100 includes the-ribs 104 and 105 formed on the upper surface thereof to facilitate the identification through naked eyes, an oval portion 107 formed on the center area to have the same height as those of the ribs 104 and 105, around the circumference of which six through holes 103 are formed in an interval away from each another and a projecting portion formed at the center area, which is used as a jaw at the time of being processed. Also, arrow indicating portions 109 and 109' are projected on both sides of the oval portion 107 to be directed contrary to each other to indicate the operating direction of the temperature sensor 20. The first and second identification holes 101 and 102 are perforated on places to be directed by the arrow indicating portions 109 and 109'. For example, the identification holes 101 are formed at a place crossing the rib 104 on the diameter line and the identification holes 102 is formed at a place crossing the rib 105. Therefore, the first and second identification holes 101 and 102 are positioned at different places from the upper center of the closure cap 100 to indicate the exposure of the temperature sensor 20, for example medicaments, to over a critical temperature or the wrong storage of the medicaments. If the first moving indication member 130 is identified through the identification hole 101, a user can judge through the first identification hole 101 whether the deteriorating of the medicament state contained in the medicament bottle 2 reached the danger state. Furthermore, if the second moving indication member 130' is identified through the identification hole 102, the user can identify that the use of the medicament contained in the medicament bottle 2 is forbidden through the first identification hole 101.
As described above, the closure cap 100 comprises the temperature sensor 20, the operating control portion 120 and the first and second moving indication members 130 and 130' in order to
Identify the storage stage of the vial 10 according to the temperature detection of the temperature sensor 20.
As shown in Fig. 13, the closure cap 100 includes a guide shaft 110 integrally projected from the upper inner center thereof. The guide shaft 110 includes a guide slit 111 formed in a direction perpendicular to a phantom line P to guide the up and down movement of the operating control member 120 and functions as a supporter. A guide groove 112 is formed on the upper inner surface of the closure cap 100 to guide the straight movement of the first and second moving indication members 130 and 130' in the same direction as that of the slit 111.
At least one pair of first supporting walls 113 and 113'.. are formed in a symmetric with respect to the photom lines P-P to provide a first space 114 in which the operating control portion 120 is seated in a manner to insert the guide plate 121 into the slit 111. At that time, the guide plate 121 is projected downward from the slit 111 and more projected downward therefrom when the push button 103 is pushed. And, the first supporting walls 113, 113' has a height equal to a value of an oval thickness of the operating control member 120 plus the diameter of the temperature sensor 20. Therefore, the first supporting walls 113, 113'.. function to restrain the variation of the temperature sensor 20 positioned in the inner of the first space 114.
Similarly, at least one pair of second supporting walls 115, 115'.. are integrally projected from the upper inner surface of the closure cap 100 to provide a second space 116 in which the first and second moving indication members 130 are 130' are seated outside the first supporting walls 113 and 113'. The second supporting walls 115, 115'.. support the crescentic bodies 131 and 132 of the moving indication members 130 and 130' to be straightly moved in the guide groove 112.
Therefore, as shown in Fig. 14A, the closure cap apparatus permits the operating control member 120 to be slidably fitted into the slit 11 of the guide shaft 110 which is formed at the upper inner center of the closure cap 100. The push buttons 122 are inserted into the through holes 103 of the closure cap 100, the ends of which is projected out of the upper surface of the closure cap 100. Then, the temperature sensor 20 of an oval shape is seated in the first space 114 between the first supporting walls 113 and 113' and the guide plate 121. The first and second moving indication members 130 and 130' are tightly seated in the guide groove 112 on the second space 114 inside the second supporting walls 115 and 115' to be slidably moved. At this time, the rectangular indication bars 133 and 134 are arranged toward the upper portion of the closure cap 100 on which the identification holes 102 and 103 are formed on the concentric circles at distances different from each other from the center. Thereafter, the upper portion of the sleeve 3 is inserted into the opening portion of the closure cap 100, or the opening portion of the closure cap 100 is closed by a plastic partition (not shown).
Referring to Figs. 14B to 14D, the closure cap 100 is pressed/attached on the upper portion of the sleeve 3 to seal the medicament bottle 1. In the procedure of this assembly, the push buttons 122 are pressed. At this time, the operating control member 120 integrated with the push buttons 120 is moved downward to force the temperature sensor 20 to be escaped from the restraint of the first supporting walls 115 and 115'. The temperature sensor 20 is free of the first supporting walls 115 and 115' while positioned adjacent the inner circumferences of the moving indication members 130 and 130'. (Fig. 14B)
Thereafter, if the vial 10 is wrongly stored at or exposed to a temperature over a critical value, the temperature sensor 20 having an oval shape is stretched into almost the first shape of an 0-ring type to force the first and second moving indication members 130 and 130' to be moved outward. In this case, the rectangular indication bar 133 of the first moving indication member 130 is positioned directly below the first identification hole 101, and the rectangular indication bar 134 of the second moving indication member 130' is positioned below a predetermined position of the upper inner surface of the closure cap 100 with being covered. Therefore, the rectangular indication bar 133 is identified through the first identification hole 101 by naked eyes. It enables a user to judge whether the product contained in the medicament bottle 1 is in a dangerous state. (Fig. 14C)
Subsequently, if the vial 10 is wrongly stored at or exposed to a temperature much far exceeding a critical value for a long term period, the temperature sensor 20 having an oval shape is stretched into the first shape of an 0-ring type to force the first and second moving indication members 130 and 130' to be further moved outward. In this case, the rectangular indication bar 133 of the first moving indication member 130 is positioned below a predetermined position of the upper inner surface of the closure cap 100 with being covered, and the rectangular indication bar 134 of the second moving indication member 130' is positioned directly below the first identification hole 101. Therefore, the rectangular indication bar 134 is identified through the second identification hole 102 by naked eyes. It enables a user to judge whether the product contained in the medicament bottle 1 is gone bad. (Fig. 14D)
Referring to Fig. 15, another example of this embodiment is illustrated. A closure cap 100 may include a plurality of identification holes A, B, C, D and A', B', C, D' formed on the upper surface thereof except for the identification holes 101 and 102. And, the closure cap 100 has the same configuration as that of this embodiment except for the number of the identification hole. Therefore, the closure cap 100 allows a user to identify the storage state according to medicine products or other products contained in a medicament bottle 1 in a step of a quality through naked eyes. These identification holes are kept in a certain interval from the center between their concentric circumferences and can be given a printing such as a numerical value, character, indication, etc. to approximate areas thereof. EMBODIMENT 3
As shown in Figs. 16 to 18, according to the embodiment of the invention, a closure cap apparatus comprises a closure cap 200 to be constituted as a simple configuration for enabling a safety storage state of medicine products contained in a medicament bottle 1.
As shown in Fig. 16, the closure cap apparatus is adapted to a vial 10 including a bottle 1 containing injection medicine, medicine products or medicament, etc., a rubber bung 2 sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve 3 fitted onto the upper mouth of the bottle above the rubber bung. The closure cap 200 is coupled with the sleeve 3 in a manner to be fitted or pressed onto the upper of the sleeve 3 through its opened lower portion.
The closure cap apparatus including a cylindrical body comprises a housing 201 projected in a predetermined width from a certain surface of the upper surface between the center and the circumference thereof, at least one identification hole formed on the housing 201 to permit the deteriorating of the medicament or the exposure of the medicament in the medicament bottle 1 to over a critical temperature to be identified through naked eyes and a projecting portion 203 projected from the center for functioning as a supporting jaw at the time of the pressing process thereof. The closure cap 200 comprises a temperature sensor 20 made of a shape memory alloy and a temperature sensor 20 having a second shape of an oval at below a critical temperature of a circle and a first shape at over a critical temperature and a C-shaped moving indication member 210 including a groove portion 211 formed to fit a part of the temperature sensor thereinto. Also, the housing 210 and the moving indication member 210 are shown by one in the drawing, but can be mounted by two on both sides of the diameter line of the temperature sensor 20. The moving indication member 210 can be painted by a color on the whole or only on a part exposed through the identification hole 212 for the easy identification. The temperature sensor 20 and the moving indication member 210 are mounted in the closure cap 20 as follows:
As shown in Fig. 17, the closure cap 200 comprises a center shaft 201 integrally projected from the upper inner center thereof, receiving wall portions 204 and 205 respectively formed downward corresponding to both walls of the housing 201 by the reference of the center shaft 201 to slidably position the moving indication member 210 between the receiving wall portions 204 and 205, first supporting walls 206 and 207 projected downward in an arc adjacent to the wall portion thereof, second supporting walls 208 projected downward in an arc adjacent to the wall portion thereof to be faced against the first supporting walls 206 and 207 and approximate wall portions 209 projected downward to form a space for positioning an arc portion of the temperature sensor 20 in part in a hollow portion formed by the second wall portions 208 and the approximate wall portions 209.
Therefore, in the closure cap 200, the arc portion of the temperature sensor 20 is inserted into the space between the second wall portion 208 and the approximate wall portion 209. The other arc portion is arranged on a space formed by the first walls 206 and 207. The closure cap 200 receives the upper portion of the sleeve 3 from the opening potion thereof or is closed by a plastic partition (not shown).
As shown in Figs. 18A and 18B, the closure cap 200 is pressed up to and fixed on the sleeve 3 to seal the medicament bottle 1. At this time, the temperature sensor 20 is mounted in the closure cap 200 to have a first shape of a circle or a second shape of an oval to force the moving indication member 210 to be identified through the indication hole 202, and vice versa.
Thereafter, if the vial 10 is stored at a proper temperature, for example below a critical one, the temperature sensor 20 is returned to its shape, for example the second shape of an oval to position the moving indication member 210 in the housing 201 on the upper portion of the closure cap 200, so that the moving indication member 210 is not exposed to an outside. Therefore, the moving indication member 210 enables a user to judge whether the product in the medicament bottle 1 is normal. (Fig. 18A)
On the contrary, if the vial 10 is wrongly stored at a proper temperature, for example over a critical one for a long term period, even if temporally, the temperature sensor 20 is stretched into the first shape of a circle to force the moving indication member 210 to be moved outward, strongly. At this case, the moving indication member 210 is slidably moved in the housing 201 to position directly below the identification hole 202 on the upper portion of the closure cap 200. Therefore, the moving indication member 210 enables the user to identify its color through naked eyes and to judge whether the product in the medicament bottle 1 is abnormal. (Fig. 18B). Also, the identification hole is replaced with the upper portion of the housing 201 to permit the storage state of the product in the medicament bottle 1 to be more closely examined through naked eyes.
As described above, a closure cap apparatus comprises a closure cap in which a temperature sensor is mounted in a predetermined arrangement, so that the closure cap is easily removed from a vial according to the storage state of the vial, otherwise its removal becomes hard. The closure cap further comprises an operating control member and a moving indication member to enable the identification on a storage state of a product in a medicament bottle through naked eyes. Also, the closure cap includes a plurality of identification holes or an elongated hole to enable the moving indication member to identify the storage state of the product in steps through naked eyes according to the kinds of the product or medicament. Therefore, the invention has advantages in that the storage product is checked directly before being damaged, so that its discard is prevented in advance and it enable the effective management of products for a user.

Claims

WHAT IS CLAIMED IS:
1. A closure cap apparatus using a shape memory alloy adapted to a vial including a bottle containing medicaments a rubber bung sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve fitted onto the upper mouth of the bottle above the rubber bung comprising:
The sleeve including a cylindrical portion surrounding a rim portion of the medicament bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact with the lower edge of the rim portion by a predetermined clamping tool; a closure cap of a two stories structure, which is made of a plastic or synthetic resin, including a receiving portion positioned in the sleeve, two annular portions of a crescentic shape integrally projected from the receiving portion to be arranged against each other and a stopper including flaps formed upright on the diameter line of the closure cap between the two annular portions to control the removal of the closure cap from the vial and a circular plate integrated with the flaps and connected on the diameter line to the inner lower portion of the annular portions; and a temperature sensor positioned on the lower surface to have a second shape at below a critical temperature and a first shape at above a critical temperature so as to control the operating of the flaps.
2. The closure cap apparatus using a shape memory alloy as claimed in Claim 1, wherein: the receiving portion includes a wall portion positioned adjacent the inner surface of the cylindrical and a circumferential portion radially and horizontally extended inward in a predetermined length from the wall portion.
3. The closure cap apparatus using a shape memory alloy as claimed in Claim 1, wherein: the stopper includes the circular plate positioned around the inner lower circumference of the annular portion and flaps extended from the circular plate in the form of the inner and upper walls of the annular portion and between both ends of the annular portions, in which the circular plate includes a folding portion having a predetermined width formed on both sides by reference of a scoring line of a diameter thereof, a hole formed at the center to insert an operating portion of the temperature sensor for the folding portion, supporting portions formed on the lower surface to support the temperature sensor and connecting portions formed at both ends to be fixed to the inner lower circumference of the annular portion.
4. The closure cap apparatus using a shape memory alloy as claimed in Claim 1 or 3, wherein: the temperature sensor is mounted in the supporting portion to move the flaps and includes an operating portion formed at the center to have a second shape at below a critical temperature and a first shape at above a critical temperature and length portions extended in a predetermined length from the operating portion to control the operating of the flaps.
5. A closure cap apparatus using a shape memory alloy adapted to a vial including a bottle containing medicaments, a rubber bung sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve fitted onto the upper mouth of the bottle above the rubber bung comprising: a sleeve including a cylindrical portion surrounding a rim portion of the bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact with the lower edge of the rim portion by a predetermined clamping tool; a closure cap including a receiving portion provided with a cylindrical wall for forming a cylindrical body and an upper surface positioned in the sleeve, annular portions including a mounting portion integrally projected from a circumferential arc of a predetermined diameter on the upper surface of the receiving portion and then horizontally extended in a predetermined width therefrom with the front surface being opened, flaps extended outward from both sides of the diameter line to prevent the removal of a temperature sensor from the mounting portion and a cutting line formed on the upper surface around the outer circumference of the mounting portion; and the temperature sensor of an O ring type changed in its diameter to have a second shape of an oval at below a critical temperature and a first shape of a regular circle at above a critical temperature so as to control the operating of the flaps.
6. The closure cap apparatus using a shape memory as claimed in Claim 5, wherein: the temperature sensor is positioned in the mounting portion to surround the circumferential wall of the mounting portion which is kept at the second shape of an oval at below a critical temperature to allow the removal thereof from the annular portion and expanded into the first shape of a circle at above the critical temperature to prevent the removal thereof from the annular portion.
7. A closure cap apparatus using a shape memory alloy adapted to a vial including a bottle containing medicaments, a rubber bung sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve fitted onto the upper mouth of the bottle above the rubber bung comprising: a sleeve including a cylindrical portion surrounding a rim portion of the bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact with the lower edge of the rim portion by a predetermined clamping tool; a temperature sensor of an O ring type changed in its diameter to have a second shape of an oval at below a critical temperature and a first shape of a circle at over a critical temperature; and a closure cap including an operating control member provided with a thickness portion of an oval similar to the temperature sensor, a guide plate formed on both sides of the narrow diameter line thereof and a plurality of push buttons projected from the upper surface to be inserted into a plurality of through-holes formed on the upper surface thereof to correspond to each another and at least one moving indication member arranged on the lower surface of the operating control member to surround the temperature sensor and including a moving member with a rectangular indication bar projected therefrom.
8. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: a plurality of ribs somewhat projected from the upper surface of the closure cap to facilitate the identification thereof through naked eyes.
9. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: a plurality of through-holes are formed in a concentric circle interval spaced form each other on the upper surface of the closure cap to be coupled with the corresponding push button of the moving members.
10. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: a projecting portion is formed at a center area to be used as a supporting jaw in the course of the press processing at the time of being assembled with the bottle.
11. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: arrow portions are formed on both sides of the oval portion contrary to each other to indicate the direction that the operating control portion is moved.
12. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: a plurality of identification holes formed at different places on the upper surface of the closure cap to identify a storage stage of a product in the medicament bottle.
13. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: a numerical value, character or indication is provided on the periphery of the identification holes.
14. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: a guide groove is formed on the upper inner surface to guide the straight movement of the moving indication members in the straight direction.
15. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: first supporting walls are formed in a symmetric with respect to each another to provides first oval hollow portions for the moving indication members, and second supporting walls are integrally projected from the upper inner surface to provide second hollow portions for the moving indication members.
16. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: the operating control member includes a plurality of push buttons to be inserted into the corresponding buttonhole of the closure cap and a guide plate integrated therewith to be slidably moved in the slit of the center shaft on the upper inner surface of the closure cap.
17. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: the moving indication members include a crescentic body having a predetermined limited length and an indicating bar projected in a predetermined length from the upper center portion of the crescent body.
18. The closure cap apparatus using a shape memory as claimed in Claim 7 or 17, wherein: the moving indication members are positioned in a guide groove portion separated from each another and include an U-characterized body formed to force the temperature sensor to be fitted thereinto, one side of which is projected to function as an indicating portion, and other side of which is extended to position its free end in the slit of the guide shaft.
19. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: the moving indication member is made of a plastic processing material having any colour to facilitate the identification thereof through naked eyes.
20. The closure cap apparatus using a shape memory as claimed in Claim 7, wherein: a lower opening portion of the closure cap includes a separate plastic partition and adhesives applied thereon to fix the closure cap on the upper surface of the rubber bung or attach the closure cap to an upper portion of a container.
21. A closure cap apparatus using a shape memory alloy adapted to a vial including a bottle containing medicaments, a rubber bung sealing the upper mouth of the bottle to prevent the leakage of the medicament therefrom and a sleeve fitted onto the upper mouth of the bottle above the rubber bung comprising: a sleeve including a cylindrical portion surrounding a rim portion of the bottle and a tubular wall portion of a closure cap, an extending portion horizontally extended in a predetermined length from the cylindrical portion, a hole formed at the center thereof and a free end bent inward from the circumference in contact with the lower edge of the rim portion by a predetermined clamping tool; a temperature sensor changed at its diameter to have a second shape of an oval at below a critical temperature and a first shape of a regular circle at above a critical temperature; and a closure cap including a housing projected in a predetermined width from the upper surface from the center close to the circumference thereof, at least one identification hole formed on the housing to permit the storage state or the exposure of the medicament to over a critical temperature to be identified through naked eyes, a C-shaped moving indication member including a groove portion formed to fit one arc portion of the temperature sensor thereinto and a projecting portion projected from the center to be used as a supporting jaw in the time of its press processing for the assembly with the bottle.
22. The closure cap apparatus using a shape memory as claimed in Claim 21, wherein: the closure cap comprises a center shaft integrally projected from the upper inner center thereof, receiving wall portions formed downward corresponding to both side walls of the housing by the reference of the center shaft to slidably receive the moving indication member between the receiving wall portions, first supporting walls projected downward in an arc adjacent to the wall portion thereof, second supporting walls projected downward in an arc adjacent to the wall portion thereof to be faced against the first supporting walls and approximate wall portions projected downward to form a space for positioning an arc portion of the temperature sensor in part in a hollow portion formed by the second wall portions and the approximate wall portions.
PCT/KR2001/001839 2001-01-19 2001-10-31 Closure cap apparatus for medicament bottle using shape memory alloy WO2002056820A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR2001/3152 2001-01-19
KR1020010003152A KR20020061977A (en) 2001-01-19 2001-01-19 Discriminating device for indication of keeping conditions using shape memory alloy

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WO2002056820A1 true WO2002056820A1 (en) 2002-07-25

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GB2474537A (en) * 2009-10-13 2011-04-20 Milan Innovation Ltd A container with a temperature activated lock
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CN108981937A (en) * 2018-04-25 2018-12-11 曹生珠 A kind of cold chain Overtemperature monitoring device and preparation method thereof
US20220074237A1 (en) * 2020-09-08 2022-03-10 Rapitag Gmbh Bottle lock

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WO2006008261A1 (en) * 2004-07-20 2006-01-26 Helvoet Pharma Belgium N.V. Container for pharmaceutical products
DE202004017459U1 (en) * 2004-11-10 2006-03-16 Diestelhorst, Michael, Prof. Dr.med. Application device for pharmaceuticals
ES2261104A1 (en) * 2006-06-19 2006-11-01 Grifols, S.A. Stopper for flasks of sterile products and use of said stopper in sterile measured filling
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CN108981937A (en) * 2018-04-25 2018-12-11 曹生珠 A kind of cold chain Overtemperature monitoring device and preparation method thereof
US20220074237A1 (en) * 2020-09-08 2022-03-10 Rapitag Gmbh Bottle lock

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