US20070095855A1 - Blow fill sealed container with twist off top operated by overcap and method of making the same - Google Patents
Blow fill sealed container with twist off top operated by overcap and method of making the same Download PDFInfo
- Publication number
- US20070095855A1 US20070095855A1 US11/639,823 US63982306A US2007095855A1 US 20070095855 A1 US20070095855 A1 US 20070095855A1 US 63982306 A US63982306 A US 63982306A US 2007095855 A1 US2007095855 A1 US 2007095855A1
- Authority
- US
- United States
- Prior art keywords
- frangible seal
- container body
- overcap
- upper cap
- closure top
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 238000004519 manufacturing process Methods 0.000 title 1
- 230000004888 barrier function Effects 0.000 claims abstract description 8
- 239000012530 fluid Substances 0.000 claims description 5
- 230000000994 depressogenic effect Effects 0.000 abstract description 5
- 230000000881 depressing effect Effects 0.000 abstract description 3
- 230000000717 retained effect Effects 0.000 description 5
- 238000011109 contamination Methods 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 230000001954 sterilising effect Effects 0.000 description 4
- 230000002708 enhancing effect Effects 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 239000003708 ampul Substances 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 230000013011 mating Effects 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- -1 polypropylene Polymers 0.000 description 2
- 239000011435 rock Substances 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 230000001010 compromised effect Effects 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920005630 polypropylene random copolymer Polymers 0.000 description 1
Images
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D51/00—Closures not otherwise provided for
- B65D51/18—Arrangements of closures with protective outer cap-like covers or of two or more co-operating closures
- B65D51/20—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing
- B65D51/22—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure
- B65D51/228—Caps, lids, or covers co-operating with an inner closure arranged to be opened by piercing, cutting, or tearing having means for piercing, cutting, or tearing the inner closure a major part of the inner closure being removed from the container after the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1412—Containers with closing means, e.g. caps
- A61J1/1431—Permanent type, e.g. welded or glued
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1475—Inlet or outlet ports
- A61J1/1481—Inlet or outlet ports with connection retaining means, e.g. thread or snap-fit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1468—Containers characterised by specific material properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1475—Inlet or outlet ports
- A61J1/1487—Inlet or outlet ports with friction fit, e.g. connecting tubes directly to a protruding port
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C2791/00—Shaping characteristics in general
- B29C2791/001—Shaping in several steps
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D2251/00—Details relating to container closures
- B65D2251/0003—Two or more closures
- B65D2251/0006—Upper closure
- B65D2251/0015—Upper closure of the 41-type
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D2251/00—Details relating to container closures
- B65D2251/0003—Two or more closures
- B65D2251/0068—Lower closure
- B65D2251/0071—Lower closure of the 17-type
Definitions
- the present invention relates to the field of containers. More particularly this invention relates to a sterile container assembly for storing fluids, including but not limited to drugs, and transferring them to a needleless syringe.
- the outlets of these ampoules are often designed to mate with the open end of a needleless syringe.
- the open ends of needleless syringes come in several different forms or shapes.
- the two most popular forms of needle fitting are the friction fit fitting (such as the luer slip fitting) and the combination of screw thread and friction engagement fitting (such as the luer lock fitting).
- Ampoules with outlets that are designed to mate with luer slip fittings and ampoules with outlets that are designed to mate with luer lock fittings are known.
- Prior solutions for keeping these ampoules sterile include utilization of blister packaging of the ampoules prior to sterilization. This blister packaging is both costly and difficult to remove.
- a principal object of this invention is to provide a container assembly that maintains a sterile attachment zone for a needleless syringe.
- Another object of the invention is to provide a container assembly that has a guarded sterile syringe attachment zone, which is easily compromised during the manual manipulation, required to open the container assembly.
- Another object reduces risk of contamination of its opened port by finger touches.
- Another object of the invention is to provide a container assembly adapted for use with a needleless syringe and which includes an overcap to facilitate removal of a closure top from the container.
- a further object of the invention is to provide an overcap with an improved detent portion for engaging the closure top of a container.
- a container assembly includes a container body having a port adapted for use with a luer end of a needleless syringe.
- a first frangible seal seals the aperture to a closure top.
- An overcap has a cap base sealed to the container body and an upper cap connected to the cap base by a second frangible seal, providing a sterile barrier surrounding the first frangible seal. Depressing the upper cap toward the container body breaks the second frangible seal. Alternatively, the second frangible seal is a removable tear strip broken by tugging on the tear strip.
- the upper cap includes a detent portion frictionally securing the upper cap to the closure top when the upper cap is depressed toward the container body. The upper cap and secured closure top are removed from container body by twisting the upper cap to break the first frangible seal. After removal, the top remains frictionally retained in the upper cap by the detent portion.
- FIG. 1 is a perspective view of the device of this invention
- FIG. 2 is a partial sectional side view of the device of this invention taken on line 2 - 2 of FIG. 1 ;
- FIG. 3 is a partial sectional side view similar to FIG. 2 , but the tear strip has been removed;
- FIG. 4 is a partial sectional side view similar to FIG. 3 , but the upper cap has been pressed downward to retentively engage the closure top;
- FIG. 5 is a partial sectional side view similar to FIG. 4 , but the overcap and the closure top retained therein have been removed;
- FIG. 6 is a partial sectional front view of a syringe and the opened container of this invention.
- FIG. 7 is a side view of a second embodiment of the device of this invention.
- FIG. 8 is a partial sectional side view of the device of this invention taken on line 8 - 8 of FIG. 7 ;
- FIG. 9 is a partial sectional side view similar to FIG. 8 , but the second frangible seal has been broken and the upper cap has been engaged with the closure top;
- FIG. 10 is a partial sectional side view of the device of this invention taken on line 10 - 10 of FIG. 9 ;
- FIG. 11 is a partial sectional side view similar to FIG. 10 , but the overcap and closure top have been rotated to fracture the first frangible seal;
- FIG. 12 is a partial sectional side view similar to FIG. 11 , but the overcap and the closure top retained therein have been removed.
- a container assembly 10 includes a container body 12 for containing fluid, including but not limited to drugs.
- An overcap 14 is sealed to the container body 12 to provide a barrier over a portion of the container body 12 to prevent contamination by touch or otherwise.
- the overcap 14 provides a sterile barrier once the entire container assembly 10 has been sterilized.
- a port 16 provides access to the contents of the container body 12 through an aperture 18 .
- a non-resealable closure top 20 is sealed over the aperture 18 to the container body 12 at a first frangible seal 22 .
- the first frangible seal 22 is a sterilized surface, where the overcap 14 is positioned over the first frangible seal 22 and sealed to the container body 12 to provide a sterile barrier or zone surrounding the first frangible seal 22 .
- a cap base 24 of overcap 14 is sealed to a horizontally extending flange 26 on the container body 12 .
- the cap base 24 has a horizontally extending lip 28 with an outer end 30 and an inner end 32 .
- An annular skirt 34 extends downwardly from the outer end 30 and mates with an outer edge 36 of flange 26 on the container body 12 .
- An annular rim 38 extends upwardly from the inner end 32 of lip 28 .
- an upper cap 40 of overcap 14 is sealed to the cap base 24 by a second frangible seal 42 .
- a cylindrical skirt portion 44 of upper cap 40 extends downwardly from an outer portion 46 of a radial extending end 48 .
- the second frangible seal 42 seals the cylindrical skirt 44 to the cap base 24 .
- a removable tear strip 50 is located between the annular rim 38 of cap base 24 and the cylindrical skirt portion 44 of upper cap 40 , forming the second frangible seal 42 .
- the tear strip 50 has a hold area 52 that extends horizontally from the overcap 14 .
- the hold area 52 permits a user to grasp and pull the hold area 52 to remove the tear strip 50 .
- tear strip 50 is removed the second frangible seal 42 is broken and the cap base 24 and upper cap 40 are severed from each other.
- a detent portion 54 of upper cap 40 frictionally attaches the closure top 20 to the upper cap 40 once the second frangible seal 42 (not shown) is broken. Once the second frangible seal 42 (not shown) is broken by removing the tear strip 50 (not shown), the upper cap 40 is depressed towards the container body 12 , mating the detent portion 54 to the closure top 20 .
- the detent portion 54 includes planar finger elements 56 extending downwardly from the end 48 of upper cap 40 and around the closure top 20 .
- Each finger element 56 includes a finger shoulder 58 mateable with a corresponding tang shoulder 60 on the closure top 20 .
- a top edge 66 of the finger shoulder 58 contacts a trailing edge 68 of the tang shoulder 60 , preventing the closure top 20 from detaching from the detent portion 54 .
- the finger shoulder 58 and the tang shoulder 60 both extend horizontally.
- a grip area 70 is located the outer surface of upper cap 40 .
- the grip area 70 permits a user to grasp and rotate the upper cap 40 .
- the mated detent portion 54 and closure top 20 twist relative to the container body 12 .
- This rotation breaks the first frangible seal 22 (not shown).
- the detent portion 54 and closure top 20 remain mated, and are removed from the container body 12 .
- the closure top 20 is retained within the upper cap 40 once removed from the container body 12 .
- the upper cap 40 provides a balanced application of torque resulting in a clean break of the first frangible seal 22 (not shown). This clean break minimizes the amount of plastic strands generated from the broken seal.
- a luer end 72 of a syringe 74 is inserted into the aperture 18 of port 16 once the closure top 20 is removed.
- the syringe 74 allows a user to extract fluid content from the container 12 .
- the luer end 72 is shown as a luer lock fitting but may be a luer slip fitting.
- the luer end 72 includes a male luer 76 and a female threaded surface 78 .
- the male luer 76 is inserted into the aperture 18 of the port 16 .
- the female threaded surface 78 is engaged to port threads 80 located on the port 16 to threadingly mate the luer end 72 to the port 16 .
- a second embodiment of the present invention includes an upper cap 82 sealed to the cap base 24 by a second frangible seal 84 .
- a cylindrical skirt portion 86 extends downwardly from a rectangular detent portion 88 of upper cap 82 .
- the cylindrical skirt 86 is located within the cap base 24 and is sealed to the cap base 24 by the second frangible seal 84 .
- the second frangible seal 84 can be broken by manually depressing the upper cap 82 toward the container body 12 , whereupon the detent portion 88 of upper cap 82 frictionally attaches to a closure top 90 .
- the user can rock the upper cap 82 back and forth until the second frangible seal 84 fractures, then push the upper cap 82 downward.
- the detent portion 88 includes substantially planar surface elements 92 extending upwardly from cylindrical skirt portion 86 of upper cap 82 and positioned around the closure top 90 .
- Each substantially planar surface element 92 corresponds to a corresponding substantially planar surface portion 94 of closure top 90 .
- One or more optional friction enhancing elements 95 are formed in one or more of the substantially planar surface elements or portions 92 , 94 .
- the friction enhancing elements 95 are shown as a pair of raised domes on the substantially planar surface portions 94 ; however, those skilled in the art will understand from the description herein that other friction enhancing elements or combinations of elements can be utilized, including but not limited to ribs, ribs and grooves, and other complementary or noncomplementary surface irregularities, without detracting from the present invention.
- the substantially planar surface elements 92 and the substantially planar portions 94 are configured so that some force is required to retentively engage planar surface elements 92 to the planar surface portions 94 .
- the planar surface elements 92 frictionally engage the planar surface portions 94 , preventing the closure top 90 from detaching from the detent portion 88 .
- a grip area 96 is located on the outer surface of upper cap 82 and at least forms a portion of the outer surface of detent portion 88 .
- the grip area 96 permits a user to grasp and rock or rotate the upper cap 82 .
- the mated detent portion 88 and closure top 90 twist relative to the container body 12 . This rotation breaks the first frangible seal 22 .
- the detent portion 88 and closure top 90 remain mated, and are removed from the container body 12 .
- the closure top 90 is retained within the upper cap 82 once removed from the container body 12 .
- the container body 12 and closure top 20 or 90 are formed by a blow/fill/seal method and then sterilized.
- the material that forms the container body 12 , the closure top 20 or 90 , and the overcap 14 can be any material suitable for blow fill molding, and autoclave sterilization including but not limited to glass and plastic. More preferably, the material is polypropylene based or polyethylene tetrachloride-based. Most preferably, the material is a polypropylene random copolymer, such as Huntsman 23M2CS30A or Exxon Mobil 9122.
- the overcap 14 is fusion welded to the container 12 .
- the container body 12 and overcap 14 assembly are then autoclaved to sterilize the entire container assembly 10 .
- the overcap 14 is not fixed to the closure top 20 or 90 during autoclaving, permitting expansion at different rates and in different dimensions so as to prevent unnecessary strain on the container assembly 10 .
- the overcap 14 preserves the sterility of first frangible seal 22 .
- the second frangible seal 42 or 84 is broken, a sterile uncontaminated port 16 remains until the closure top 20 or 90 is rotated by the overcap 14 and removed from the container 12 .
- the present invention provides a container assembly that maintains a sterile barrier or zone around the port until just prior to use.
- the present invention further provides a container assembly adapted for use with a syringe and which includes an overcap to facilitate removal of a closure top from the container with a twisting motion rather than the usual rocking motion that can lead to spillage and contamination by touch.
- the present invention also provides an overcap with an improved detent portion for engaging the closure top of a container.
Abstract
A container assembly includes a container body having a port or aperture adapted for use with a luer end of a needleless syringe. The aperture is sealed to a closure top by a first frangible seal. An overcap has a cap base sealed to the container body and an upper cap connected to the cap base by a second frangible seal, providing a sterile barrier surrounding the first frangible seal. The second frangible seal is broken by depressing the upper cap toward the container body. Alternatively, the second frangible seal is a removable tear strip broken by tugging on the tear strip. The upper cap includes a detent portion frictionally securing the upper cap to the closure top when the upper cap is depressed toward the container body. The upper cap and secured closure top are removed from container body by twisting the upper cap to break the first frangible seal and open the port.
Description
- The present invention relates to the field of containers. More particularly this invention relates to a sterile container assembly for storing fluids, including but not limited to drugs, and transferring them to a needleless syringe.
- In the past, the general practice of surgeons or other medical practitioners using hypodermic syringes has been to transfer an injection solution to a syringe from ampoules or vials holding a single dose. These ampoules have been adapted to be sealed by a non-resealable cap. The ampoule is opened by rocking the non-resealable cap, tearing the non-resealable cap from an outlet of the ampoule at an area of weakness.
- The outlets of these ampoules are often designed to mate with the open end of a needleless syringe. The open ends of needleless syringes come in several different forms or shapes. The two most popular forms of needle fitting are the friction fit fitting (such as the luer slip fitting) and the combination of screw thread and friction engagement fitting (such as the luer lock fitting). Ampoules with outlets that are designed to mate with luer slip fittings and ampoules with outlets that are designed to mate with luer lock fittings are known.
- It will be appreciated that this past practice has required separate sterilizing measures, as solution transfer for injecting into humans requires scrupulous sterilizing of components.
- Prior solutions for keeping these ampoules sterile include utilization of blister packaging of the ampoules prior to sterilization. This blister packaging is both costly and difficult to remove.
- Other types of conventional containers have a cover that the user turns to engage the cap and tear the cap from the container. None of these containers are adapted to operate with a needleless syringe. Further, none of these containers are particularly well adapted to prevent compromise or contamination of the sterile port of the container during the manual manipulation required to open the port.
- Therefore, a principal object of this invention is to provide a container assembly that maintains a sterile attachment zone for a needleless syringe.
- Another object of the invention is to provide a container assembly that has a guarded sterile syringe attachment zone, which is easily compromised during the manual manipulation, required to open the container assembly.
- Another object reduces risk of contamination of its opened port by finger touches.
- Another object of the invention is to provide a container assembly adapted for use with a needleless syringe and which includes an overcap to facilitate removal of a closure top from the container.
- A further object of the invention is to provide an overcap with an improved detent portion for engaging the closure top of a container.
- These and other objects will be apparent to those skilled in the art.
- A container assembly includes a container body having a port adapted for use with a luer end of a needleless syringe. A first frangible seal seals the aperture to a closure top. An overcap has a cap base sealed to the container body and an upper cap connected to the cap base by a second frangible seal, providing a sterile barrier surrounding the first frangible seal. Depressing the upper cap toward the container body breaks the second frangible seal. Alternatively, the second frangible seal is a removable tear strip broken by tugging on the tear strip. The upper cap includes a detent portion frictionally securing the upper cap to the closure top when the upper cap is depressed toward the container body. The upper cap and secured closure top are removed from container body by twisting the upper cap to break the first frangible seal. After removal, the top remains frictionally retained in the upper cap by the detent portion.
-
FIG. 1 is a perspective view of the device of this invention; -
FIG. 2 is a partial sectional side view of the device of this invention taken on line 2-2 ofFIG. 1 ; -
FIG. 3 is a partial sectional side view similar toFIG. 2 , but the tear strip has been removed; -
FIG. 4 is a partial sectional side view similar toFIG. 3 , but the upper cap has been pressed downward to retentively engage the closure top; -
FIG. 5 is a partial sectional side view similar toFIG. 4 , but the overcap and the closure top retained therein have been removed; -
FIG. 6 is a partial sectional front view of a syringe and the opened container of this invention; -
FIG. 7 is a side view of a second embodiment of the device of this invention; -
FIG. 8 is a partial sectional side view of the device of this invention taken on line 8-8 ofFIG. 7 ; -
FIG. 9 is a partial sectional side view similar toFIG. 8 , but the second frangible seal has been broken and the upper cap has been engaged with the closure top; -
FIG. 10 is a partial sectional side view of the device of this invention taken on line 10-10 ofFIG. 9 ; -
FIG. 11 is a partial sectional side view similar toFIG. 10 , but the overcap and closure top have been rotated to fracture the first frangible seal; and -
FIG. 12 is a partial sectional side view similar toFIG. 11 , but the overcap and the closure top retained therein have been removed. - With reference to
FIG. 1 , acontainer assembly 10 includes acontainer body 12 for containing fluid, including but not limited to drugs. Anovercap 14 is sealed to thecontainer body 12 to provide a barrier over a portion of thecontainer body 12 to prevent contamination by touch or otherwise. Theovercap 14 provides a sterile barrier once theentire container assembly 10 has been sterilized. - Referring to
FIG. 2 , aport 16 provides access to the contents of thecontainer body 12 through anaperture 18. Anon-resealable closure top 20 is sealed over theaperture 18 to thecontainer body 12 at a firstfrangible seal 22. The firstfrangible seal 22 is a sterilized surface, where theovercap 14 is positioned over the firstfrangible seal 22 and sealed to thecontainer body 12 to provide a sterile barrier or zone surrounding the firstfrangible seal 22. - A
cap base 24 ofovercap 14 is sealed to a horizontally extendingflange 26 on thecontainer body 12. Thecap base 24 has a horizontally extendinglip 28 with anouter end 30 and aninner end 32. Anannular skirt 34 extends downwardly from theouter end 30 and mates with anouter edge 36 offlange 26 on thecontainer body 12. Anannular rim 38 extends upwardly from theinner end 32 oflip 28. - Referring to
FIGS. 2 and 3 , anupper cap 40 ofovercap 14 is sealed to thecap base 24 by a secondfrangible seal 42. Acylindrical skirt portion 44 ofupper cap 40 extends downwardly from anouter portion 46 of a radial extendingend 48. The secondfrangible seal 42 seals thecylindrical skirt 44 to thecap base 24. - A
removable tear strip 50 is located between theannular rim 38 ofcap base 24 and thecylindrical skirt portion 44 ofupper cap 40, forming the secondfrangible seal 42. Thetear strip 50 has ahold area 52 that extends horizontally from theovercap 14. Thehold area 52 permits a user to grasp and pull thehold area 52 to remove thetear strip 50. Whentear strip 50 is removed the secondfrangible seal 42 is broken and thecap base 24 andupper cap 40 are severed from each other. - Referring to
FIGS. 3 and 4 , adetent portion 54 ofupper cap 40 frictionally attaches theclosure top 20 to theupper cap 40 once the second frangible seal 42 (not shown) is broken. Once the second frangible seal 42 (not shown) is broken by removing the tear strip 50 (not shown), theupper cap 40 is depressed towards thecontainer body 12, mating thedetent portion 54 to theclosure top 20. - The
detent portion 54 includesplanar finger elements 56 extending downwardly from theend 48 ofupper cap 40 and around theclosure top 20. Eachfinger element 56 includes afinger shoulder 58 mateable with a correspondingtang shoulder 60 on theclosure top 20. - Some force is required to move a
bottom edge 62 of thefinger shoulder 58 over a leadingedge 64 of thetang shoulder 60. Once theupper cap 40 is depressed, atop edge 66 of thefinger shoulder 58 contacts a trailingedge 68 of thetang shoulder 60, preventing the closure top 20 from detaching from thedetent portion 54. Although various mating configurations are possible, preferably thefinger shoulder 58 and thetang shoulder 60 both extend horizontally. - Referring to
FIG. 5 , agrip area 70 is located the outer surface ofupper cap 40. Thegrip area 70 permits a user to grasp and rotate theupper cap 40. As theupper cap 40 is rotated, the mateddetent portion 54 and closure top 20 twist relative to thecontainer body 12. This rotation breaks the first frangible seal 22 (not shown). Once the first frangible seal 22 (not shown) is broken, thedetent portion 54 and closure top 20 remain mated, and are removed from thecontainer body 12. Theclosure top 20 is retained within theupper cap 40 once removed from thecontainer body 12. - The
upper cap 40 provides a balanced application of torque resulting in a clean break of the first frangible seal 22 (not shown). This clean break minimizes the amount of plastic strands generated from the broken seal. - Referring to
FIG. 6 , aluer end 72 of asyringe 74 is inserted into theaperture 18 ofport 16 once theclosure top 20 is removed. Thesyringe 74 allows a user to extract fluid content from thecontainer 12. Theluer end 72 is shown as a luer lock fitting but may be a luer slip fitting. Theluer end 72 includes amale luer 76 and a female threadedsurface 78. Themale luer 76 is inserted into theaperture 18 of theport 16. The female threadedsurface 78 is engaged toport threads 80 located on theport 16 to threadingly mate theluer end 72 to theport 16. - Referring to
FIGS. 7 through 12 , a second embodiment of the present invention includes anupper cap 82 sealed to thecap base 24 by a secondfrangible seal 84. Acylindrical skirt portion 86 extends downwardly from arectangular detent portion 88 ofupper cap 82. Thecylindrical skirt 86 is located within thecap base 24 and is sealed to thecap base 24 by the secondfrangible seal 84. The secondfrangible seal 84 can be broken by manually depressing theupper cap 82 toward thecontainer body 12, whereupon thedetent portion 88 ofupper cap 82 frictionally attaches to aclosure top 90. Alternatively, the user can rock theupper cap 82 back and forth until the secondfrangible seal 84 fractures, then push theupper cap 82 downward. - The
detent portion 88 includes substantiallyplanar surface elements 92 extending upwardly fromcylindrical skirt portion 86 ofupper cap 82 and positioned around theclosure top 90. Each substantiallyplanar surface element 92 corresponds to a corresponding substantiallyplanar surface portion 94 ofclosure top 90. One or more optionalfriction enhancing elements 95 are formed in one or more of the substantially planar surface elements orportions friction enhancing elements 95 are shown as a pair of raised domes on the substantiallyplanar surface portions 94; however, those skilled in the art will understand from the description herein that other friction enhancing elements or combinations of elements can be utilized, including but not limited to ribs, ribs and grooves, and other complementary or noncomplementary surface irregularities, without detracting from the present invention. At any rate, the substantiallyplanar surface elements 92 and the substantiallyplanar portions 94 are configured so that some force is required to retentively engageplanar surface elements 92 to theplanar surface portions 94. Once theupper cap 82 is depressed, theplanar surface elements 92 frictionally engage theplanar surface portions 94, preventing the closure top 90 from detaching from thedetent portion 88. - Referring to
FIGS. 7, 10 and 12, agrip area 96 is located on the outer surface ofupper cap 82 and at least forms a portion of the outer surface ofdetent portion 88. Thegrip area 96 permits a user to grasp and rock or rotate theupper cap 82. As theupper cap 82 is rotated, the mateddetent portion 88 and closure top 90 twist relative to thecontainer body 12. This rotation breaks the firstfrangible seal 22. Once the firstfrangible seal 22 is broken, thedetent portion 88 and closure top 90 remain mated, and are removed from thecontainer body 12. Theclosure top 90 is retained within theupper cap 82 once removed from thecontainer body 12. - Referring to
FIGS. 2 and 8 , during formation, thecontainer body 12 and closure top 20 or 90 are formed by a blow/fill/seal method and then sterilized. The material that forms thecontainer body 12, the closure top 20 or 90, and theovercap 14 can be any material suitable for blow fill molding, and autoclave sterilization including but not limited to glass and plastic. More preferably, the material is polypropylene based or polyethylene tetrachloride-based. Most preferably, the material is a polypropylene random copolymer, such as Huntsman 23M2CS30A or Exxon Mobil 9122. Theovercap 14 is fusion welded to thecontainer 12. Thecontainer body 12 andovercap 14 assembly are then autoclaved to sterilize theentire container assembly 10. Theovercap 14 is not fixed to the closure top 20 or 90 during autoclaving, permitting expansion at different rates and in different dimensions so as to prevent unnecessary strain on thecontainer assembly 10. Once theentire container assembly 10 is sterilized, theovercap 14 preserves the sterility of firstfrangible seal 22. When the secondfrangible seal uncontaminated port 16 remains until the closure top 20 or 90 is rotated by theovercap 14 and removed from thecontainer 12. - It is therefore seen that the present invention provides a container assembly that maintains a sterile barrier or zone around the port until just prior to use. The present invention further provides a container assembly adapted for use with a syringe and which includes an overcap to facilitate removal of a closure top from the container with a twisting motion rather than the usual rocking motion that can lead to spillage and contamination by touch. The present invention also provides an overcap with an improved detent portion for engaging the closure top of a container.
- It is therefore seen that this invention will accomplish at least all of its stated objectives.
Claims (9)
1. A container assembly, comprising:
a container body adapted to contain fluid, including a port having an aperture therein;
a closure top attached over the aperture of the container body with a first frangible seal; and
an overcap positioned over the first frangible seal and hermetically sealed to the container body to provide a sterile barrier surrounding the first frangible seal.
2. The container assembly of claim 1 , wherein the port is adapted for use with a luer end of a needleless syringe.
3. The container assembly of claim 2 , wherein the luer end is a luer lock fitting.
4.-11. (canceled)
12. A container assembly for use with a needleless syringe having a luer end, comprising:
a container body adapted to contain fluid, including a port having an aperture therein adapted for use with a luer end of a syringe;
a closure top attached over the aperture of the container body with a first frangible seal; and
an overcap including a detent portion for associating the overcap to the closure top to allow a user to break the first frangible seal and remove the closure top by twisting the overcap;
wherein the overcap is positioned over the first frangible seal and hermetically sealed to the container body to provide a sterile barrier surrounding the first frangible seal.
13. The container assembly of claim 12 , wherein the luer end is a luer lock fitting.
14.-18. (canceled)
19. The container assembly of claim 12 , wherein the detent portion frictionally attaches the closure top to the overcap.
20.-30. (canceled)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/639,823 US20070095855A1 (en) | 2003-09-05 | 2006-12-15 | Blow fill sealed container with twist off top operated by overcap and method of making the same |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/655,718 US7188750B2 (en) | 2003-09-05 | 2003-09-05 | Blow fill sealed container with twist off top operated by overcap and method of forming the same |
US11/639,823 US20070095855A1 (en) | 2003-09-05 | 2006-12-15 | Blow fill sealed container with twist off top operated by overcap and method of making the same |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/655,718 Continuation US7188750B2 (en) | 2003-09-05 | 2003-09-05 | Blow fill sealed container with twist off top operated by overcap and method of forming the same |
Publications (1)
Publication Number | Publication Date |
---|---|
US20070095855A1 true US20070095855A1 (en) | 2007-05-03 |
Family
ID=34226186
Family Applications (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/655,718 Expired - Fee Related US7188750B2 (en) | 2003-09-05 | 2003-09-05 | Blow fill sealed container with twist off top operated by overcap and method of forming the same |
US11/639,823 Abandoned US20070095855A1 (en) | 2003-09-05 | 2006-12-15 | Blow fill sealed container with twist off top operated by overcap and method of making the same |
US11/643,136 Abandoned US20070102850A1 (en) | 2003-09-05 | 2006-12-20 | Blow fill sealed container with twist off top operated by overcap and method of making the same |
US11/643,133 Abandoned US20070102446A1 (en) | 2003-09-05 | 2006-12-21 | Blow fill sealed container with twist off top operated by overcap and method of making the same |
US11/643,135 Abandoned US20070095856A1 (en) | 2003-09-05 | 2006-12-21 | Blow fill sealed container with twist off top operated by overcap and method of making the same |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/655,718 Expired - Fee Related US7188750B2 (en) | 2003-09-05 | 2003-09-05 | Blow fill sealed container with twist off top operated by overcap and method of forming the same |
Family Applications After (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/643,136 Abandoned US20070102850A1 (en) | 2003-09-05 | 2006-12-20 | Blow fill sealed container with twist off top operated by overcap and method of making the same |
US11/643,133 Abandoned US20070102446A1 (en) | 2003-09-05 | 2006-12-21 | Blow fill sealed container with twist off top operated by overcap and method of making the same |
US11/643,135 Abandoned US20070095856A1 (en) | 2003-09-05 | 2006-12-21 | Blow fill sealed container with twist off top operated by overcap and method of making the same |
Country Status (6)
Country | Link |
---|---|
US (5) | US7188750B2 (en) |
EP (1) | EP1670411A1 (en) |
JP (1) | JP2007503919A (en) |
AU (1) | AU2004271980A1 (en) |
CA (1) | CA2537296A1 (en) |
WO (1) | WO2005025483A1 (en) |
Cited By (1)
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EP2301378A1 (en) | 2009-09-23 | 2011-03-30 | L'Oréal | Dispenser of a cosmetic product on a receiving surface, associated dispenser and method |
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EP2301378A1 (en) | 2009-09-23 | 2011-03-30 | L'Oréal | Dispenser of a cosmetic product on a receiving surface, associated dispenser and method |
Also Published As
Publication number | Publication date |
---|---|
WO2005025483A1 (en) | 2005-03-24 |
US20070102850A1 (en) | 2007-05-10 |
US7188750B2 (en) | 2007-03-13 |
AU2004271980A1 (en) | 2005-03-24 |
CA2537296A1 (en) | 2005-03-24 |
US20070095856A1 (en) | 2007-05-03 |
US20070102446A1 (en) | 2007-05-10 |
EP1670411A1 (en) | 2006-06-21 |
US20050051572A1 (en) | 2005-03-10 |
JP2007503919A (en) | 2007-03-01 |
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Date | Code | Title | Description |
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STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |