WO2008042939A2 - Molded container with raised nipple and method for use - Google Patents
Molded container with raised nipple and method for use Download PDFInfo
- Publication number
- WO2008042939A2 WO2008042939A2 PCT/US2007/080267 US2007080267W WO2008042939A2 WO 2008042939 A2 WO2008042939 A2 WO 2008042939A2 US 2007080267 W US2007080267 W US 2007080267W WO 2008042939 A2 WO2008042939 A2 WO 2008042939A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- wall
- container
- stopper
- body portion
- longitudinal axis
- Prior art date
Links
- 210000002445 nipple Anatomy 0.000 title claims abstract description 56
- 238000000034 method Methods 0.000 title claims description 12
- 238000000926 separation method Methods 0.000 claims abstract description 47
- 238000002347 injection Methods 0.000 claims description 27
- 239000007924 injection Substances 0.000 claims description 27
- 230000014759 maintenance of location Effects 0.000 claims description 12
- 230000002708 enhancing effect Effects 0.000 claims description 10
- 238000012546 transfer Methods 0.000 claims description 8
- 230000000750 progressive effect Effects 0.000 claims description 7
- 230000009969 flowable effect Effects 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 238000004140 cleaning Methods 0.000 abstract description 4
- 238000013461 design Methods 0.000 description 12
- 229920001169 thermoplastic Polymers 0.000 description 8
- 230000008901 benefit Effects 0.000 description 6
- 239000004416 thermosoftening plastic Substances 0.000 description 5
- 230000003993 interaction Effects 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 238000012986 modification Methods 0.000 description 4
- 230000004048 modification Effects 0.000 description 4
- 238000010276 construction Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000011521 glass Substances 0.000 description 3
- 238000004806 packaging method and process Methods 0.000 description 3
- 239000004033 plastic Substances 0.000 description 3
- 230000004075 alteration Effects 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 239000011888 foil Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000002483 medication Methods 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 230000003466 anti-cipated effect Effects 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 238000012865 aseptic processing Methods 0.000 description 1
- 238000000071 blow moulding Methods 0.000 description 1
- 238000010924 continuous production Methods 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 239000000806 elastomer Substances 0.000 description 1
- 238000005538 encapsulation Methods 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 239000002991 molded plastic Substances 0.000 description 1
- 238000012354 overpressurization Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
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
- B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1406—Septums, pierceable membranes
-
- 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
- B65D1/00—Rigid or semi-rigid containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material or by deep-drawing operations performed on sheet material
- B65D1/02—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
- B65D1/0223—Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by shape
- B65D1/023—Neck construction
- B65D1/0238—Integral frangible closures
-
- 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
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2048—Connecting means
- A61J1/2055—Connecting means having gripping means
-
- 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
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
Definitions
- the invention relates to the field of molded containers, particularly to a blow-fill-seal (BFS) vial containing an internal elastomeric stopper, where the elastomeric stopper has a raised nipple that projects beyond the outer shell of the vial.
- BFS blow-fill-seal
- Small vials with elastomeric stoppers are traditionally used to contain small amounts of liquids, particularly liquid medications, or as storage and dispensing vessels for lyophilized medications that are reconstituted prior to use. Safe retention of the elastomeric stopper requires a foil over-cap, to prevent the expulsion of the stopper should pressure within the vial rise. Additionally, the elastomeric stoppers generally require siliconization as a lubricant to insert the stoppers in the vials during the manufacturing process, thus introducing a potentially additional chemical compound. Furthermore, glass vials are inherently liable to breakage. In the end, a stoppered glass vial requires at least three different structural compounds (glass, elastomers, and foil), and assembly requires numerous steps.
- BFS low-fill-seal containers
- resin is extruded and molded into a container, and the container is then filled and the resin container sealed, all is a series of automated steps, generally carried out in a continuous or near-continuous process in a sterile environment within the BFS molding machinery.
- the evolution of this method of packaging is also well known in the art. Initially, various methods were described for blow molding a hollow thermoplastic article; for example, as seen in U.S. Pat. Nos. 3, 137,748 and 3,288,898. More complex process for manufacturing BFS containers are later seen in U.S. Pat. Nos.
- the BFS manufacturing process traditionally includes sub-components such as a thermoplastic polymer storage and feeding system; an extruder with a parison head; a sterile air filling chamber; a specialized mandrel capable of filling the container, mold halves capable of opening and closing, and therein forming the container; and various downstream items of equipment, such as inspection and leak detection systems, labelers, and packaging machinery.
- sub-components such as a thermoplastic polymer storage and feeding system; an extruder with a parison head; a sterile air filling chamber; a specialized mandrel capable of filling the container, mold halves capable of opening and closing, and therein forming the container; and various downstream items of equipment, such as inspection and leak detection systems, labelers, and packaging machinery.
- Aseptic processing equipment such as tanks fitted with sterility filters, ensures that the BFS machinery is continuously provided with sterile product.
- Thermoplastic polymer granules are typically fed via a vacuum tubing system into a hopper in the blow-fill-seal extruder, where they are heated to form a melt, typically at about 215° C.
- the thermoplastic polymer melt is formed via a circular orifice into a plastic parison (hollow tube), which is held open by a stream of sterile filtered air.
- the lower part of the divided mold halves then close to seal the bottom of the open parison and the parison wall is blown and/or compressed by vacuum to the cooled mold walls to form the lower part of the BFS container.
- a filling mandrel fills a predetermined quantity of product into the container, and after withdrawal of the mandrel, the upper portion of the mold closes to form and seal the upper part of the BFS container.
- an intermediate step includes placement of the insert in the correct position prior to encapsulation as part of the BFS process. Since multiple cavities may be built within a single mold, the rate of production is substantially related to the number of cavities in each BFS mold. Vials with encapsulated stoppers generally resemble the type of prior art construction as illustrated in FIG. 1. There are a number of problems with such a construction.
- the relatively right angle shoulder where the encapsulated thermoplastic turns over the top of the stopper creates an area that is difficult to blow mold.
- the need for a reproducible fracture area wherein the vial may be opened requires a weakened area for such a fracture area, which can be difficult to design into such packaging.
- the designs owing to the fact that the stopper is encapsulated within the thermoplastic shell, result in a stopper surface that lies below the level of the shell.
- the exposed surface of the stopper essentially lies in a hole, surround by a raised thermoplastic area, as seen in FIG. 2. This can make access to the stopper, such as for cleaning and disinfection difficult.
- the instant invention overcomes these and many other shortcomings of contemporary BFS vial design.
- the present invention advances the state of the art with a variety of new capabilities and overcomes many of the shortcomings of prior devices in new and novel ways.
- the present invention is a molded container having a raised nipple, formed according to the traditional blow-fill-seal (BFS) methods described above.
- the container comprises a cap portion, a body portion, and with an encapsulated stopper.
- the body portion has a body portion wall having a wall shoulder portion with a distal aspect and a proximal aspect.
- the body portion has an adjoining cap portion such that the body portion wall meets a cap portion wall at an engineered separation site, designed to represent an area of weakness in the walls of the container.
- the container has a stopper enclosed within the container shell that prevents the transfer of contents from the body portion to the cap portion.
- a portion of the stopper is enclosed within the body portion and a portion of the stopper is enclosed within the cap portion.
- the stopper has a stopper wall and a stopper shoulder with a central raised nipple having a nipple top surface with an injection site and a nipple sidewall.
- the engineered separation site is adjacent to the nipple sidewall such that when the cap portion is removed from the body portion at the engineered separation site, a portion of the nipple extends out of the body portion.
- the instant invention allows all of the top surface of the nipple to be easily cleaned, if desired, and allows substantially all of the top surface of the nipple to be accessed by a needle, or other removal means, to puncture the stopper and access the container contents.
- the body wall shoulder portion, adjacent to the cap portion may be configured at a non-orthogonal angle from the longitudinal axis of the container. This also has numerous advantages over the prior art, including but not limited to the following. It can be difficult, when the body wall should of a BFS vial comprises an orthogonal angle, to insure sufficient plastic at the bend to form a sufficiently strong container.
- the wall shoulder portion further comprises at least one raised gusset, extending from the wall shoulder portion and having a lateral surface substantially parallel to the longitudinal axis of the container.
- gusset(s) not only tend to strengthen the BFS vial, but cooperate with a variety of connectors. Extending the length of the lateral surface increases the surface area of interaction between the container and the interior surface of a needle-free container, and a larger surface area for interaction results in a more stable cooperation between the elements and a more positive centering of a needle-free connector.
- the cap portion may have a cap portion wall formed with a grip enhancing feature such as a flattened tab (332), see FIGS 13 (a) and 13(b).
- a flattened tab 332
- Such a flattened tab may have relatively short lateral expanse such that the easiest means of removing the cap portion from the body portion is to use two hands, one to grip the body portion and another to twist off the cap portion. While one-handed removal of the cap portion in such a design is not impossible, it may require a degree of hand strength not universally found among those desiring to use the container.
- the hand strength required for one-handed opening may be decreased by increasing the moment arm of the tab, that is, the larger the tab relative to the container, the less force that must be applied at a distal point on the tab to effect a rupture at the engineered separation site. This allows easier removal of the cap portion from the body portion by torquing the cap portion. Such relative elongation of the tab simply increases the leverage available for opening the container at the engineered separation site.
- the engineered separation site comprises a line of discontinuity in shell thickness between the body portion wall and the cap portion wall.
- the discontinuity creates a natural fracture zone between the adjoining body portion and cap portion
- the engineered separation site is formed by a progressive attenuation of the thickness of the wall shoulder portion tapering from a maximum thickness at the distal aspect of the wall shoulder portion to reach a minimum thickness at the proximal aspect of the wall shoulder portion (221), see FIG. 7.
- a container (10) with at least one diameter (12) and a longitudinal axis (14), comprising a container shell (50) comprising a body portion (200) with a body portion wall (220) having a wall shoulder portion (221) configured at a non-orthogonal angle from the longitudinal axis (14) of the container (10) having a distal aspect (222) and a proximal aspect (223) wherein the wall shoulder portion (221) further comprises at least one raised gusset (228) extending from the wall shoulder portion (221) and having a lateral surface (229) substantially parallel to the longitudinal axis (14) of the container (10) wherein the lateral surface (229) begins at the distal aspect (222) of the wall shoulder portion (221) and extends substantially parallel to the longitudinal axis (14) of the container at least 25% of the longitudinal distance from the distal aspect (222) to the injection site (135) measured along the longitudinal axis (14) of the container (10), and an adjoining cap portion (300) having a cap
- a container (10) with at least one diameter (12) and a longitudinal axis (14), comprising a container shell (50) comprising a body portion (200) with a body portion wall (220) having a wall shoulder portion (221) configured at a non-orthogonal angle from the longitudinal axis (14) of the container (10) having a distal aspect (222) and a proximal aspect (223) wherein the wall shoulder portion (221) further comprises at least one raised gusset (228) extending from the wall shoulder portion (221) and having a lateral surface (229) substantially parallel to the longitudinal axis (14) of the container (10) wherein the lateral surface (229) begins at the distal aspect (222) of the wall shoulder portion (221) and extends substantially parallel to the longitudinal axis (14) of the container at least 25% of the longitudinal distance from the distal aspect (222) to the injection site (135) measured along the longitudinal axis (14) of the container (10), and an adjoining cap portion (300) having a cap
- FIG. 1 is a cross section view of an embodiment of a prior art molded container
- FIG. 2 is a cross section view of a prior art molded container with a cap portion removed;
- FIG. 3 is a side elevation view of an embodiment of the instant invention.
- FIG. 4 is a cross section view of the cap portion and a part of a body portion of the present invention.
- FIG. 5 is a cross section view of a part of the body portion of the embodiment of the instant invention of FIG. 4, with the cap portion removed;
- FIG. 6 is a cross section view of a stopper of the instant invention;
- FIG. 7 is a cross section view of the cap portion, the stopper, and a part of the body portion of another embodiment of the molded container of the instant invention;
- FIG. 8 is a cross section view of a part of the body portion of the embodiment of FIG. 5, and a needle-free connector;
- FIG. 9a is a cross section view showing potential misalignment between the body portion of the embodiment of FIG. 5, and a needie-free connector;
- FIG. 9b is a top plan view of an embodiment of the instant invention, showing raised gussets extending from a wall shoulder portion;
- FIG. 10 is a cross section view of a part of the body portion of the BFS vial and a needle-free connector;
- FIG. 1 1 is a cross section view of a part of the body portion of the embodiment of the instant invention with the needle- free connector inserted;
- FIG. 12a is a top plan view of a prior art needle-free connector suitable for use with the instant invention.
- FIG. 12b is a side elevation view of a prior art needle-free connector suitable for use with the instant invention.
- FIG. 12c is a bottom plan view of a prior art needle-free connector suitable for use with the instant invention
- FIG. 12d is a cross section view of a prior art needle-free connector suitable for use with the instant invention
- FIG. 13a is a top plan view of an embodiment of the instant invention
- FIG. 13b is a side elevation view of an embodiment of the instant invention
- FIG. 14a is a top plan view of an embodiment of the instant invention
- FIG. 14b is a side elevation view of an embodiment of the instant invention.
- the molded container (10), see FIG. 4, of the instant invention enables a significant advance in the state of the art.
- the detailed description set forth below in connection with the drawings is intended merely as a description of the presently preferred embodiments of the invention, and is not intended to represent the only form in which the present invention may be constructed or utilized.
- the description sets forth the designs, functions, means, and methods of implementing the invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and features may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention.
- the instant invention comprises a molded container (10) with at least one diameter (12), see FIG.
- the container (10) comprises a cap portion (300) and a body portion (200) with an encapsulated stopper (100).
- the container has a container shell (50) comprising a body portion (200) with a body portion wall (220) having a wall shoulder portion (221) having a distal aspect (222) and a proximal aspect (223), best seen in FIG. 5.
- distal and proximal are intended to represent positions relatively farther and relatively nearer, respectively, from the longitudinal axis (14) of the container (10).
- the body portion (200) has an adjoining cap portion (300), seen in FIG. 4, having a cap portion wall (320), wherein the body portion wall (220) meets the cap portion wall (320) at an engineered separation site (400), seen in FIG. 4.
- the engineered separation site (400) is designed to represent an area of weakness in the walls (220, 320) of the container, such that a uniform and repeatable breakage area is created for the removal of the cap portion (300) from the body portion (200).
- the container (10) has a stopper (100), well seen in FIG. 5 and shown in detail removed from the container in FIG. 6, enclosed within the container shell (50), seen in FIG. 4, that prevents the transfer of contents from the body portion (200) to the cap portion (300).
- a portion of the stopper (100) is enclosed within the body portion (200) and a portion of the stopper (100) is enclosed within the cap portion (300), as seen in FIG. 4.
- the stopper (100) has a stopper wall (120) and a stopper shoulder (123), see FIG. 6, with a central raised nipple (130) having a nipple top surface (134) with an injection site (135) and a nipple sidewall (132), as seen in FIG. 5.
- the engineered separation site (400), see FIG. 4, is adjacent to the nipple sidewall (132) such that when the cap portion (300) is removed from the body portion (200) at the engineered separation site (400) a portion of the nipple (130) extends out of the body portion (200), as seen in FIGS. 4 and 5.
- the relatively small hole means that the care giver has only a very small surface area to hit with the needle, or other removal means, used to puncture the stopper and access the container contents.
- the instant invention allows all of the top surface (134) of the nipple (130) to be easily cleaned, if desired, and allows substantially all of the top surface (134) of the nipple (130) to be accessed by a needle, or other removal means, to puncture the stopper (100) and access the container (10) contents.
- the injection site (135) on the top surface (134) of the nipple (130) is bounded by a raised injection guide (136) to assist in correct placement of the needle or other removal means into the stopper (100).
- the body wall shoulder portion (221), adjacent to the cap portion (300), may be configured at a non-orthogonal angle, seen in FIG. 5, from the longitudinal axis (14) of the container (10).
- This also has numerous advantages over the prior art.
- the traditional BFS vial such as the prior art examples seen in FIGS. 1 and 2, have shoulders over the embedded stoppers that are configured approximately orthogonally to a longitudinal axis of the container, resulting in approximately a right-angle bend at the most lateral portion of the shoulder area. It can be difficult, given such an orthogonal angle, to insure sufficient plastic at the bend, to form a sufficiently strong container, using traditional BFS methods.
- the instant invention may also be configured so that the body portion wall (220) has an ingress preventer (224), seen in FIGS. 4 and 5, wherein the ingress preventer (224) cooperates with a stopper ingress preventer (124) formed in the stopper wall (120).
- the ingress preventer (224) cooperates with a stopper ingress preventer (124) formed in the stopper wall (120).
- a wall retention surface (226) on the body portion wall (220) cooperates with a stopper retention surface (126) on the stopper wall (120).
- such cooperation may provide sufficient frictional fit so that the stopper (100) is less likely to be forced into, or expelled from, the container (10).
- the wall retention surface (226) further comprises at least one wall egress preventer (227), wherein the wall egress preventer (227) cooperates with a stopper egress preventer (127) on the stopper retention surface (126).
- the wall shoulder portion (221) further comprises at least one raised gusset (228), seen in FIGS. 9b and 10, extending from the wall shoulder portion (221) and having a lateral surface (229) substantially parallel to the longitudinal axis (14) of the container (10).
- Such gusset(s) (228) not only tend to strengthen the BFS vial, but may cooperate with a variety of needle-free connectors, such as, by way of example only, the SMARTSITE® needle-free connector manufactured by Cardinal Health, Inc. of Dublin, Ohio, USA.
- a larger surface area for interaction results in a more stable cooperation between the elements and a more positive centering of a needle-free connector, as will be discussed immediately below in relationship to FIGS. 8-11.
- FIGS. 8-1 The advantage of the at least one raised gusset design may be seen in FIGS. 8-1 1.
- a needle free connector (500) see FIG. 12a, of the type, by way of example only, of the SMARTSITE® needle-free connector poised at the moment of puncture of the injection site (135), see FIG. 8, of the raised nipple (130).
- FIG. 9a One skilled in the art can see, as would be confirmed by reference to FIG. 9a, that it is relatively easy for an operator to place the needle-free connector (500) eccentrically on the container (10), potentially leading to an unstable connection and an improper puncturing of the injection surface (135).
- Typical features of a needle-free connector (500) may be seen in FIGS. 12a- 12d, as well as in FIGS. 8, 9a, and 10-1 1.
- some of the features of a typical needle-free connector include a connector male end fluid port ingress regulator (523), essentially shaped as a spike-like means for puncturing the stopper (100) at the injection site (135) and a connector male end fluid port interlock (524), essentially configured as resilient clips that allow the needle-free connector (500) to cooperate with various configurations of the body portion (200) of the container (10).
- the raised gusset (228) design particularly embodiments employing a lateral surface (229) substantially parallel to the longitudinal axis of the container (10), may be appreciated by one skilled in the art as illustrated in FIG. 10.
- the raised gusset(s) (228) As the needle-free connector approaches the top of the container (10), the raised gusset(s) (228), particularly the lateral edges (229), interacts with the clip-like sides of the needle-free connector. This tends to guide the needle- free connector to a proper central placement on the injection site (135).
- the raised gusset(s) (228) tend to fill the interior volume of the needle-free connector and to insure a closer and more stable fit with the body portion (200) of the container (10).
- FIGS. 12a-d The details of a typical needle-free container suitable for use with the instant invention are shown, by way of example only, in FIGS. 12a-d.
- the cap portion (300) may have a cap portion wall (320) formed with a grip enhancing feature (330).
- a grip enhancing feature (330) may be a flattened tab (332) having a lateral aspect (333).
- Various embodiments employing different geometries maybe useful in facilitating the opening of the container (10) which is often of a relatively small size.
- the grip enhancing features may be a flattened tab (332) attached to the cap portion (300), seen in FIGS. 13a-b and 14a-b.
- a flattened tab (332) may have relatively short lateral expanse such that the easiest means of removing the cap portion (300) from the body portion (200) is to use two hands, one to grip the body portion (200) and another to twist off the cap portion (300).
- Such a twisting motion is shown in FIG. 13b by the two-headed arrow indicating rotation that is shown on the cap portion (300). While one-handed removal of the cap portion (300) in such a design is not impossible, it may require a degree of hand strength not universally found among those desiring to use the container (10).
- the hand strength required for one-handed opening may be decreased by increasing the moment arm of the tab (332) that is, the larger the tab (332) relative to the container (10), the less force that must be applied at a distal point on the tab (332) to effect a rupture at the engineered separation site (400).
- a tab (332) is shown in FIGS. 7 and 14b formed such that a distance from a most distant point on the tab (332), at the lateral aspect (333), from a center of the injection site (135) is at least 50% of the largest of the at least one diameter (12) of the container (10). A similar construction may be seen in FIG. 14b.
- the tab (332) is formed such that a distance from a most distant point on the tab (332), at the lateral aspect (333), from a center of the injection site (135) is at least 65% of the largest of the at least one diameter (12) of the container (10), as may be seen in FIG. 7 and FIG. 14b. Such relative elongation of the tab (332) simply increases the leverage available for opening the container (10) at the engineered separation site (400).
- Clean and accurate removal of the cap portion (300) from the body portion (200) may also be facilitated by refinements in the engineered separation site (400) where the body portion wall (220) meets the cap portion wall (320).
- a site (400) could comprise, by way of example, a score line in the shell wall (52).
- the engineered separation site (400) comprises a line of discontinuity in shell thickness between the body portion wall (220) and the cap portion wall (320). The discontinuity creates a natural fracture zone between the adjoining body portion (200) and cap portion (300). As seen in FIG.
- the engineered separation site (400) is formed by a progressive attenuation of the thickness of the wall shoulder portion (221), see FIG. 5, tapering from a maximum thickness at the distal aspect (222) of the wall shoulder portion (221) to reach a minimum thickness at the proximal aspect (223) of the wall shoulder portion (221).
- the container with a raised nipple of the instant invention answers a long- felt need in the area of BFS containers having internally encapsulated stoppers.
- the design of the invention allows a portion of the raised nipple to extend beyond the body portion of the container, after opening, such that it may be easily accessed and cleaned. Additional modifications, including the provision of an improved engineered separation site at the point of opening, and raised gussets that may provide a secure connection with various needle-free connectors improves the safety and efficiency found in this art.
Landscapes
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Ceramic Engineering (AREA)
- Life Sciences & Earth Sciences (AREA)
- Closures For Containers (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Containers Having Bodies Formed In One Piece (AREA)
- Details Of Rigid Or Semi-Rigid Containers (AREA)
- Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
- Auxiliary Devices For And Details Of Packaging Control (AREA)
- Casting Or Compression Moulding Of Plastics Or The Like (AREA)
- Blow-Moulding Or Thermoforming Of Plastics Or The Like (AREA)
- Moulding By Coating Moulds (AREA)
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AT07843722T ATE494235T1 (en) | 2006-10-04 | 2007-10-03 | MOLDING CONTAINER WITH RAISED NIPPLE AND USE |
BRPI0720340-3A BRPI0720340B1 (en) | 2006-10-04 | 2007-10-03 | CONTAINER WITH AT LEAST ONE DIAMETER AND LONGITUDINAL GEOMETRIC SHAFT AND METHOD FOR STORING AND DISPENSING A FLOWABLE SUBSTANCE INSIDE A CONTAINER. |
EP07843722A EP2066570B1 (en) | 2006-10-04 | 2007-10-03 | Molded container with raised nipple and use |
DE602007011785T DE602007011785D1 (en) | 2006-10-04 | 2007-10-03 | FORM CONTAINER WITH LEVERED NIPPLE AND USE |
JP2009531572A JP5199265B2 (en) | 2006-10-04 | 2007-10-03 | Molded container with raised nipple and method of use |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/542,869 | 2006-10-04 | ||
US11/542,869 US20080083691A1 (en) | 2006-10-04 | 2006-10-04 | Molded container with raised nipple and method for use |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2008042939A2 true WO2008042939A2 (en) | 2008-04-10 |
WO2008042939A3 WO2008042939A3 (en) | 2008-12-04 |
Family
ID=39271606
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2007/080267 WO2008042939A2 (en) | 2006-10-04 | 2007-10-03 | Molded container with raised nipple and method for use |
Country Status (8)
Country | Link |
---|---|
US (2) | US20080083691A1 (en) |
EP (1) | EP2066570B1 (en) |
JP (1) | JP5199265B2 (en) |
CN (1) | CN101600627A (en) |
AT (1) | ATE494235T1 (en) |
BR (1) | BRPI0720340B1 (en) |
DE (1) | DE602007011785D1 (en) |
WO (1) | WO2008042939A2 (en) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2018060333A1 (en) * | 2016-09-28 | 2018-04-05 | Fresenius Kabi Deutschland Gmbh | Sealing cap for a container for holding a medical liquid |
US10086984B2 (en) | 2009-06-30 | 2018-10-02 | R.P. Scherer Technologies, Llc | Molded container with opener and method for use |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20100254637A1 (en) * | 2009-04-04 | 2010-10-07 | Joseph John Lesko | Handheld packet for one-handed operation |
USD666289S1 (en) | 2010-07-23 | 2012-08-28 | BFS Pharma, Inc. | Unit dose vial |
WO2012026551A1 (en) * | 2010-08-27 | 2012-03-01 | 大塚製薬株式会社 | Medical liquid container |
US8672165B2 (en) | 2011-11-22 | 2014-03-18 | Spherical Precision, Inc. | Containers with dispensing cap and methods of manufacturing the same |
US9132238B2 (en) * | 2012-06-26 | 2015-09-15 | Becton, Dickinson And Company | Blow fill seal luer syringe |
US9364393B1 (en) | 2012-08-17 | 2016-06-14 | Healthstar, Inc. | Packaging system for liquid medications |
DE102012109194A1 (en) | 2012-09-27 | 2014-04-17 | B. Braun Avitum Ag | Tamper-evident closure for use on a container, container therewith and port for location on the container |
AU2015339828B2 (en) | 2014-10-29 | 2020-03-19 | R.P. Scherer Technologies, Llc | Inverse blow-fill-seal packaging |
WO2017001925A1 (en) | 2015-07-02 | 2017-01-05 | Marc Andrew Koska | Single use delivery device prefilled with a reconstitutable agent |
KR102487355B1 (en) * | 2016-04-25 | 2023-01-11 | 코스카 패밀리 리미티드 | medical delivery system |
EP3710086A4 (en) * | 2017-11-17 | 2021-11-17 | Koska Family Limited | Systems and methods for fluid delivery manifolds |
CN112906624B (en) * | 2021-03-12 | 2022-09-13 | 合肥工业大学 | Video data feature extraction method based on audio and video multi-mode time sequence prediction |
USD992110S1 (en) | 2021-08-10 | 2023-07-11 | Koska Family Limited | Sealed fluid container |
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TWI303565B (en) * | 2002-08-16 | 2008-12-01 | Glaxosmithkline Biolog Sa | Closure system,vial having the closure system,method of closing a vial,method of filling a pharmaceutical vial, and vial closure |
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GB0318242D0 (en) * | 2003-08-04 | 2003-09-03 | Glaxosmithkline Biolog Sa | Novel device |
JP4579576B2 (en) * | 2004-05-18 | 2010-11-10 | ファーマパック株式会社 | Resin container and manufacturing method thereof |
-
2006
- 2006-10-04 US US11/542,869 patent/US20080083691A1/en not_active Abandoned
-
2007
- 2007-10-03 CN CNA2007800434865A patent/CN101600627A/en active Pending
- 2007-10-03 BR BRPI0720340-3A patent/BRPI0720340B1/en not_active IP Right Cessation
- 2007-10-03 WO PCT/US2007/080267 patent/WO2008042939A2/en active Application Filing
- 2007-10-03 AT AT07843722T patent/ATE494235T1/en not_active IP Right Cessation
- 2007-10-03 DE DE602007011785T patent/DE602007011785D1/en active Active
- 2007-10-03 JP JP2009531572A patent/JP5199265B2/en active Active
- 2007-10-03 EP EP07843722A patent/EP2066570B1/en active Active
-
2009
- 2009-03-11 US US12/402,047 patent/US20090230077A1/en not_active Abandoned
Non-Patent Citations (2)
Title |
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None |
See also references of EP2066570A4 |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10086984B2 (en) | 2009-06-30 | 2018-10-02 | R.P. Scherer Technologies, Llc | Molded container with opener and method for use |
WO2018060333A1 (en) * | 2016-09-28 | 2018-04-05 | Fresenius Kabi Deutschland Gmbh | Sealing cap for a container for holding a medical liquid |
US11034491B2 (en) | 2016-09-28 | 2021-06-15 | Fresenius Kabi Deutschland Gmbh | Sealing cap for a container for holding a medical liquid |
US12116188B2 (en) | 2016-09-28 | 2024-10-15 | Fresenius Kabi Deutschland Gmbh | Sealing cap for a container for holding a medical liquid |
Also Published As
Publication number | Publication date |
---|---|
EP2066570A4 (en) | 2009-11-11 |
EP2066570B1 (en) | 2011-01-05 |
US20090230077A1 (en) | 2009-09-17 |
BRPI0720340A2 (en) | 2014-06-24 |
US20080083691A1 (en) | 2008-04-10 |
JP2010505710A (en) | 2010-02-25 |
CN101600627A (en) | 2009-12-09 |
ATE494235T1 (en) | 2011-01-15 |
JP5199265B2 (en) | 2013-05-15 |
WO2008042939A3 (en) | 2008-12-04 |
EP2066570A2 (en) | 2009-06-10 |
DE602007011785D1 (en) | 2011-02-17 |
BRPI0720340B1 (en) | 2019-02-26 |
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