WO2016114867A2 - Tamper evident closure container - Google Patents

Tamper evident closure container Download PDF

Info

Publication number
WO2016114867A2
WO2016114867A2 PCT/US2015/064707 US2015064707W WO2016114867A2 WO 2016114867 A2 WO2016114867 A2 WO 2016114867A2 US 2015064707 W US2015064707 W US 2015064707W WO 2016114867 A2 WO2016114867 A2 WO 2016114867A2
Authority
WO
WIPO (PCT)
Prior art keywords
casing member
container
closure container
tamper evident
evident closure
Prior art date
Application number
PCT/US2015/064707
Other languages
French (fr)
Other versions
WO2016114867A3 (en
Inventor
Aaron HRISCHMANN
Robert Hacker
Robert FESUS
Christopher J. GRIMES
Hannah M. TALBOT GRIFFITH
Original Assignee
Plas-Tech Engineering, Inc.
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 Plas-Tech Engineering, Inc. filed Critical Plas-Tech Engineering, Inc.
Priority to NZ731002A priority Critical patent/NZ731002A/en
Priority to CA2967041A priority patent/CA2967041C/en
Priority to AU2015377191A priority patent/AU2015377191A1/en
Priority to EP15878277.1A priority patent/EP3244942B1/en
Priority to ES15878277T priority patent/ES2825654T3/en
Publication of WO2016114867A2 publication Critical patent/WO2016114867A2/en
Publication of WO2016114867A3 publication Critical patent/WO2016114867A3/en
Priority to AU2020230336A priority patent/AU2020230336B2/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525—Dosing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • 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
    • B65D55/00—Accessories for container closures not otherwise provided for
    • B65D55/02—Locking devices; Means for discouraging or indicating unauthorised opening or removal of closure
    • B65D55/06—Deformable or tearable wires, strings, or strips; Use of seals, e.g. destructible locking pins

Definitions

  • a health provider may need a larger or smaller dose depending on the size or age of the patient and fumbling with a vial and a needle may add precious seconds before treatment and potential dosing errors.
  • sterilization is important whenever it comes to administering a drug to a patient through a needle and a health care provider has to know if the needle being used and the drug being administered have not been tampered with. Accordingly, the art of emergency treatment could benefit from a device that promotes quick access to a drug applicator which may be stored in pre-set doses and provides evidence of tampering.
  • the present invention relates to a closure container, and more particularly to a container that can house a preset drug applicator in an easily accessible manner with tamper evidencing means .
  • such container may include a first casing member and a mateable a second casing member, the second casing member having an inner surface with a plurality of transverse dosing ribs, a bridge, and a retainer projecting therefrom that are configured to cradle a syringe containing a predetermined amount of fluid.
  • the container may be formed as a unitary injection-molded piece with the first casing member and second casing member hingedly connected by a living hinge.
  • the container further includes a fastener having a tamper- evident pull-tab, the fastener being connected to one of the first casing member and the second casing member and configured to releasably maintain closure of the container.
  • a fastener having a tamper- evident pull-tab, the fastener being connected to one of the first casing member and the second casing member and configured to releasably maintain closure of the container.
  • a female stacking structure may be formed on one of the first casing member and the second casing member and a male stacking structure may be formed on the other of the first casing member and the second casing member.
  • the female stacking structure may include one or a plurality of holes provided in the one of the first casing member and the second casing member.
  • the male stacking structure may be formed as one or more catches protruding from the other of the first casing member and the second casing member in an orientation and spacing commensurate with the female stacking structure. Each catch may have an arm extending substantially parallel with and spaced from a planar portion of an outer surface of the other of the first casing member and the second casing member.
  • the male stacking structure may include one or more tabs extending substantially perpendicularly from an outer surface of the other of the first casing member and the second casing member, the tabs being arranged in an orientation and spacing commensurate with the female stacking structure.
  • Each tab may have a protuberance spaced from the outer surface of the other of the first casing member and the second casing member by a distance substantially equivalent to a thickness defined between and including an inner surface and an outer surface of the one of the first casing member and the second casing member.
  • the fastener may depend from the first casing member and include a barb, which is receivable in a slot formed in the second casing member.
  • the first casing member may include an inner surface with a plurality of transverse dosing ribs, a bridge, and a retainer projecting inwardly therefrom and configured to at least partially surround the syringe.
  • the transverse dosing ribs of the first casing member may be longitudinally offset from the transverse dosing ribs of the second casing member.
  • each transverse dosing rib may be placed to correspond to a different selected predetermined amount of fluid in the syringe.
  • the predetermined amount of fluid may be selected from the group of fluid measurements consisting of 0.25 mL, 0.5 mL, 0.75 mL, and 1.0 mL .
  • a window surface may be formed on one of the first casing member and the second casing member, wherein the window is formed on the first casing member by masking a window portion of the first casing member with a mask material, surface treating at least a portion of each of the first casing member and the second casing member, and removing the mask material from the window portion.
  • the window surface may be positioned on the container to enable visual access to a barrel of a retained syringe.
  • the system may include a first closure container and a second closure container, wherein each container may include a first casing member and a mateable a second casing member, the second casing member having an inner surface with a plurality of transverse dosing ribs, a bridge, and a retainer projecting therefrom that are configured to cradle a syringe containing a predetermined amount of fluid.
  • the container may be formed as a unitary injection- molded piece with the first casing member and second casing member hingedly connected by a living hinge.
  • the container further includes a fastener having a tamper-evident pull- tab, the fastener being connected to one of the first casing member and the second casing member and configured to releasably maintain closure of the container.
  • a female stacking structure may be formed on one of the first casing member and the second casing member and a male stacking structure may be formed on the other of the first casing member and the second casing member.
  • the male stacking structure of the first closure container may be mated with the female stacking structure of the second closure container .
  • Figure 1 is a perspective view of a first embodiment of a tamper evident closure container according to the present invention.
  • Figure 2 is a perspective view of the container shown in Figure 1 in an open state and holding a syringe.
  • Figure 3 is another perspective view of the container shown in Figure 1 in an open, empty state.
  • Figure 4 is a top plan view of the container shown in Figure 1.
  • Figure 5 is a bottom plan view of the container shown in Figure 1.
  • Figure 6 is a front elevation view of the container shown in Figure 1.
  • Figure 7 is a rear elevation view of the container shown in Figure 1.
  • Figure 8 is a right side elevation view of the container shown in Figure 1.
  • Figure 9 is a left side elevation view of the container shown in Figure 1.
  • Figure 10 is a top plan view of the container as shown in Figure 3.
  • Figure 11 is a bottom plan view of the container as depicted in Figure 3.
  • Figure 12 is a front elevation view of the container as shown in Figure 3.
  • Figure 13 is a rear elevation view of the container as depicted in Figure 3.
  • Figure 14 is a right side elevation view of the container as shown in Figure 3.
  • Figure 15 is a left side elevation view of the container as depicted in Figure 3.
  • Figures 16-19 depict a progressive method of enclosing a syringe in the first embodiment of the container according to the present invention.
  • Figure 20 is a cross-sectional view along line 20-20 of Figure 19.
  • Figure 21 is a perspective view of a plurality of containers according to the first embodiment of the present invention stacked one on top of the other.
  • Figure 22 is a selected cut-away view of Figure
  • Figure 23 is a perspective view of a second embodiment of a tamper evident closure container according to the present invention.
  • Figure 24 is a perspective view of a plurality of containers according to the second embodiment of the present invention stacked one on top of the other.
  • Figure 25 is a cut-away view of selected section Fig. 25 of Figure 24.
  • the closure container 10 preferably comprises a single injection-molded piece having a first casing member 100 hingedly attached to a second casing member 200 by at least one hinge 12 (see Figure 2), which may be a living hinge .
  • the first casing member 100 may generally be formed along a longitudinal length between and including a first end 102 opposite a second end 104, an outer surface 106, a peripheral edge portion 116 (Figure 2), a fastener 118, and an inner surface 132 ( Figure 2) .
  • the outer surface 106 of the first casing member 100 extends from the first end 102 to the second end 104 and to the peripheral edge portion 116.
  • the outer surface 106 has a planar portion 108 with a window 110 preferably provided therein and a plurality of catches 112 projecting therefrom.
  • Each catch 112 preferably has an L-shape profile and extends outward from the planar portion 108, whereby an arm 114 of the L-shape is spaced from and substantially parallel with the planar portion 108 of the outer surface 106, and all of the catches 112 are oriented preferably in the same direction.
  • the fastener 118 is flexibly connected at or near the peripheral edge portion 116 of the first casing member 100 opposite the hinge 12.
  • the fastener 118 has a width 120, a thickness 122, an exterior surface 124, an interior surface 126, and a tamper-evident pull-tab 130.
  • a barb 128 projects from the interior surface 126 distal to the outer surface 106 of the first casing member 100.
  • the tamper-evident pull-tab 130 preferably extends substantially perpendicular from the fastener 118 between the barb 128 and the outer surface 106 of the first casing member 100.
  • the tamper-evident pull-tab 130 is preferably offset from the exterior surface 124 of the fastener 118 in a direction away from the container 10 when the fastener 118 is in an engaged position, as discussed further below.
  • the inner surface 132 of the first casing member 100 can be seen in Figures 2 and 3.
  • the inner surface 132 extends from the first end 102 to the second end 104 and to the peripheral edge portion 116, and preferably has an at least substantially planar portion 134.
  • a bridge 136 with a notch 138 projects from the planar portion 134 of the inner surface 132 near the first end 102 to or near the peripheral edge portion 116.
  • a retainer 140 extends from the planar surface 134 to or near the peripheral edge portion 116 and comprises a first wall 142, with a first wall notch 144, and a second wall 146, with a second wall notch 148, substantially parallel to the first wall 142.
  • a plurality of dosing ribs 152 project from the planar portion 134 to or near the peripheral edge portion 116 and are spaced between the second end 104 and the second wall 146 of the retainer 140.
  • Each dosing rib 152 has a notch 154, an innermost side 156 (hidden), and an outermost side 158.
  • the spacing between the dosing ribs 152 relates to the predetermined dosage provided in a syringe 50 ( Figure 2) to be contained within the closure container 10.
  • the preferable dosing amounts for which the ribs 152 will be spaced are 0.25mL, 0.5mL, 0.75mL, and l.OmL, but other dosing amounts are contemplated.
  • the second casing member 200 may be seen in Figures 2 and 3 as well.
  • the second casing member 200 has a first end 202 opposite a second end 204, an outer surface 206, a peripheral edge portion 216, and an inner surface 232.
  • the outer surface 206 of the second casing member 200 extends from the first end 202 to the second end 204 and to the peripheral edge portion 216.
  • the outer surface 206 preferably has an at least substantially planar portion 208 with a plurality of holes 260 ( Figure 5) therein which are sized, positioned, and configured to be mateable with the catches 112 of the first casing member 100 of another closure container 10.
  • the outer surface 206 of the second casing member 200 has a recess 262 with a width 264 slightly greater than the width 120 of the fastener 118 and a depth 266 preferably similar to the thickness 122 of the fastener 118.
  • a slot 268 sized and configured to receive the barb 128 of the fastener 118 is provided within the recess 268.
  • the inside surface 232 of the second casing member 200 is shown.
  • the inside surface 232 of the second casing member 200 is preferably substantially similar to the inside surface 132 of the first casing member 100.
  • the inner surface 232 extends from the first end 202 to the second end 204 and to the peripheral edge portion 216, and preferably has a planar portion 234.
  • a bridge 236 with a notch 238 projects from the planar portion 234 of the inner surface 232 near the first end 202 to or near the peripheral edge portion 216.
  • a retainer 240 extends from the planar portion 208 to or near the peripheral edge portion 216 and comprises a first wall 242, with a first wall notch 244, and a second wall 246, with a second wall notch 248, substantially parallel to the first wall 242.
  • the first wall 242 is spaced apart from the second wall 246 a distance 250.
  • a plurality of dosing ribs 252 project from the planar portion 234 of the inner surface 232 to or near the peripheral edge portion 216 and are spaced between the second end 204 and the second wall 246 of the retainer 240.
  • Each dosing rib 252 has a notch 254, an innermost side 256, and an outermost side 258.
  • the spacing between the dosing ribs 252 relates to the predetermined dosage provided in a syringe 50 ( Figure 2) to be contained within the closure container 10.
  • the preferable dosing amounts for which the ribs 252 will be spaced are 0.25mL, 0.5mL, 0.75mL, and l.OmL, however, other dosing amounts are contemplated.
  • the dosing ribs 152 of the first casing member 100 may be staggered from the dosing ribs 252 of the second casing member 200 to provide more dosing options while still providing secure support of the syringe 50 and the plunger 52.
  • first casing member 100 or the second casing member 200 may not contain the respective dosing ribs, retainer, or the bridge; instead being configured simply to cover the other casing member 200,100.
  • closure container 10 is depicted in from various views with the syringe 50 positioned within the container 10 and the fastener 118 engaged with the second casing member 200. As shown, when the container 10 is in a closed position, the fastener 118 preferably resides substantially within the recess 262, with the barb 128 received within the slot 268.
  • the material from which the closure container 10 is formed is preferably initially transparent.
  • the window 110 is preferably formed by covering the area in which the window 110 will be located, treating at least the outer surfaces 106,206 of the first casing member 100 and the second casing member 200, respectively, to decrease the transparency of those surfaces, and removing the covering to reveal the window 110.
  • the treatment may be performed by any process now known or later discovered, including but not limited to, chemical etching, mechanical etching (e.g., sand blasting) , or during the molding process using textured dies .
  • a syringe 50 can be viewed through the window 110 in a pre-set dosage configuration, ready for use.
  • the window 110 is preferably located at least radially outward from the barrel 64 of the syringe 50 to provide a care provider with a view of the syringe 50 and preferably the dosage amount provided in the barrel 64 without having to open the closure container 10.
  • Figure 16 illustrates the syringe 50 with a predetermined dosage provided in the barrel 64 prior to placement within the second casing member 200; however, the syringe 50 may be placed within the first casing member 100 as well, as shown in Figure 17.
  • the flange 60 of the syringe 50 is placed within the retainer 140 of the first casing member 100 with a portion of the barrel 64 received by the notch 144 of the first wall 142 and another portion of the barrel 64 received by the notch 138 of the bridge 136.
  • the distance 150 between the first and second walls 142,146 of the retainer 140 ( Figure 10) is preferably slightly greater than the thickness 62 of the syringe flange 60.
  • the top 54 of the plunger 52 has a topside surface 56 and an underside surface 58.
  • the underside surface 58 of the syringe top 54 preferably resides against or near the outermost side 158 of the respective dosing rib 152.
  • the placement of the flange 60 within the retainer 140 and the top 54 against the dosing rib 152 reduces the likelihood that the syringe 50 will be accidentally discharged prior to use.
  • Figure 18 illustrates the closing of the container 10 with the first and second casing members 100,200 rotating about the hinge 12 ( Figure 17) and adjoining the first casing member peripheral edge portion 116 ( Figure 17) with the second casing member peripheral edge portion 216 ( Figure 17) .
  • the barrel 64 of the syringe 50 is thereby also received within the bridge notch 238, the retainer 240, and the respective dosing rib notch 254 of the second casing member 200 (see Figure 17) .
  • the fastener 118 is wrapped around the outside surface 206 of the second casing member 200 within the recess 262.
  • the barb 128 is engageably received within the slot 268 to retain the fastener 118 in the engaged position.
  • the health care personnel will pull the tamper-evident pull-tab 130 away from the container 10 which will tear through the fastener 118 and sever the fastener's connection between the first and second casing members 100,200, thus allowing the container 10 to be opened and the syringe 50 to be removed.
  • Removal of the tamper-evident pull-tab 130 permanently detaches at least a portion of the fastener 118 from the first casing member 100 when pulled to gain access to the syringe 50. Therefore, tampering with the fastener 118 or the tamper-evident pull-tab in an attempt to gain access to the syringe 50 will be visibly noticeable by a tear in the fastener 118.
  • Figures 21 and 22 demonstrate how multiple containers 10A, 10B,10C may be stacked one on top of the other .
  • a mateable stacking interaction between a catch 112A and a hole 260B is shown.
  • the interaction allows the containers 10A, 10B to be removably interlocked.
  • the catch 112A, along with the other three catches (not shown) , of the first container 10A are inserted within the holes 260B of the second container 10B and the containers 10A, 10B, are slid in opposite directions relative to one another to place the arm 114A of the first container 10A adjacent to the inner surface 232B of the second container second casing member 200B.
  • Figure 23 illustrates a second embodiment 20 of the closure container according to the present invention.
  • the closure container 20 has tabs 470 projecting from the planar portion 408 of the second casing member outer surface 406 and apertures 390 (Figure 24) provided through the planar portion 308 of the first casing member outer surface 306.
  • the apertures 390 are alignable and mateable with the tabs 470 of a corresponding closure container 20.
  • Each tab 470 has a width 472 (Figure 24), an inward face 476, and an outward face 480.
  • the tabs 470 preferably extend substantially perpendicular away from the outside surface planar portion 408 and comprise a protuberance 478, or similarly shaped protrusion, on the inward face 476 at or near the distal end portion 482 ( Figure 25) of each tab 470.
  • the protuberance 478 may protrude from the outward face 480.
  • the apertures 390 have a width 392 and an abutting surface 396.
  • the width 392 of the apertures 390 is preferably slightly greater than the width 472 of the tabs 470.
  • Figures 24 and 25 demonstrate how multiple containers 20A, 20B,20C may be stacked by inserting the tabs 470B of a second container 20B within the apertures 390A of a first container 20B. This action is depicted by the dashed lines in Figure 24. In this fashion, stacking of these embodiments 20 require only a singular directional movement, rather than the compound movement that may be utilized to stack cases according to the first embodiment 10.
  • Figure 25 more closely illustrates the interaction between a tab 470B of the second container 20B is received within an aperture 390 of the first container 20A to provide a releasable connection between the two containers 20A, 20B.
  • the inner face 476B of the tab 470B is substantially flush with the abutting surface 396A of the aperture 390A, whereby the protuberance 478B of the tab 470B is in contact with the planar portion 334A of the first casing member inner surface 332A and the first container's second casing member outer surface planar portion 308A is flush with the second container's first casing member outer surface planar portion 408B.
  • a tamper evident closure container comprising :
  • first casing member and a second casing member having an inner surface with a plurality of transverse dosing ribs, a bridge, and a retainer projecting therefrom that are configured to cradle a syringe containing a predetermined amount of fluid;
  • a fastener having a tamper-evident pull-tab, the fastener being connected to one of the first casing member and the second casing member and configured to releasably maintain closure of the container;

Abstract

A closure container that can house a preset drug applicator in an easily accessible manner with tamper evidencing means. The closure container contains a plurality of dosing ribs and a retainer to retain the syringe in a preset dosage amount and preferably has a window to view the barrel of the syringe. The container is also configured to be removably attached to other closure containers.

Description

Tamper Evident Closure Container
Background of the Invention
Success rates with respect to action taken in response to an emergency situation almost always improve with proper preparation, access to the proper equipment, and speed. This could not be more true than in the case of providing a dose of fluid (e.g., epinephrine to a patient experiencing a severe or life-threatening allergic reaction (anaphylaxis)). According to the National Institute of Allergy and Infectious Diseases, early treatment with epinephrine is beneficial to patients having an anaphylactic episode because the patient could experience a rapid decline in health or death within 30 to 60 minutes. Such early treatment may also be beneficial in patients experiencing seizure activity.
In addition to quick administration of treatment, accurate dosing is crucial because not enough medicine may be ineffective and too much may cause health risks, such as dangerously high blood pressure, stroke, or death. During an anaphylactic event, for example, a health provider may need a larger or smaller dose depending on the size or age of the patient and fumbling with a vial and a needle may add precious seconds before treatment and potential dosing errors.
Further, sterilization is important whenever it comes to administering a drug to a patient through a needle and a health care provider has to know if the needle being used and the drug being administered have not been tampered with. Accordingly, the art of emergency treatment could benefit from a device that promotes quick access to a drug applicator which may be stored in pre-set doses and provides evidence of tampering.
Summary of the Invention
The present invention relates to a closure container, and more particularly to a container that can house a preset drug applicator in an easily accessible manner with tamper evidencing means .
According to an aspect of a tamper evident closure container according to the present invention, such container may include a first casing member and a mateable a second casing member, the second casing member having an inner surface with a plurality of transverse dosing ribs, a bridge, and a retainer projecting therefrom that are configured to cradle a syringe containing a predetermined amount of fluid. The container may be formed as a unitary injection-molded piece with the first casing member and second casing member hingedly connected by a living hinge. The container further includes a fastener having a tamper- evident pull-tab, the fastener being connected to one of the first casing member and the second casing member and configured to releasably maintain closure of the container. A female stacking structure may be formed on one of the first casing member and the second casing member and a male stacking structure may be formed on the other of the first casing member and the second casing member.
According to another aspect of a tamper evident closure container according to the present invention, the female stacking structure may include one or a plurality of holes provided in the one of the first casing member and the second casing member. According to still another aspect of a tamper evident closure container according to the present invention, the male stacking structure may be formed as one or more catches protruding from the other of the first casing member and the second casing member in an orientation and spacing commensurate with the female stacking structure. Each catch may have an arm extending substantially parallel with and spaced from a planar portion of an outer surface of the other of the first casing member and the second casing member. Additionally or alternatively, the male stacking structure may include one or more tabs extending substantially perpendicularly from an outer surface of the other of the first casing member and the second casing member, the tabs being arranged in an orientation and spacing commensurate with the female stacking structure. Each tab may have a protuberance spaced from the outer surface of the other of the first casing member and the second casing member by a distance substantially equivalent to a thickness defined between and including an inner surface and an outer surface of the one of the first casing member and the second casing member.
According to yet another aspect of a tamper evident closure container according to the present invention, the fastener may depend from the first casing member and include a barb, which is receivable in a slot formed in the second casing member.
According to a further aspect of a tamper evident closure container according to the present invention, the first casing member, like the second, may include an inner surface with a plurality of transverse dosing ribs, a bridge, and a retainer projecting inwardly therefrom and configured to at least partially surround the syringe. The transverse dosing ribs of the first casing member may be longitudinally offset from the transverse dosing ribs of the second casing member. According to a still further aspect of a tamper evident closure container according to the present invention, each transverse dosing rib may be placed to correspond to a different selected predetermined amount of fluid in the syringe. The predetermined amount of fluid may be selected from the group of fluid measurements consisting of 0.25 mL, 0.5 mL, 0.75 mL, and 1.0 mL .
According to yet a further aspect of a tamper evident closure container according to the present invention, a window surface may be formed on one of the first casing member and the second casing member, wherein the window is formed on the first casing member by masking a window portion of the first casing member with a mask material, surface treating at least a portion of each of the first casing member and the second casing member, and removing the mask material from the window portion. The window surface may be positioned on the container to enable visual access to a barrel of a retained syringe.
According to an aspect of a system for retaining syringes, the system may include a first closure container and a second closure container, wherein each container may include a first casing member and a mateable a second casing member, the second casing member having an inner surface with a plurality of transverse dosing ribs, a bridge, and a retainer projecting therefrom that are configured to cradle a syringe containing a predetermined amount of fluid. The container may be formed as a unitary injection- molded piece with the first casing member and second casing member hingedly connected by a living hinge. The container further includes a fastener having a tamper-evident pull- tab, the fastener being connected to one of the first casing member and the second casing member and configured to releasably maintain closure of the container. A female stacking structure may be formed on one of the first casing member and the second casing member and a male stacking structure may be formed on the other of the first casing member and the second casing member. The male stacking structure of the first closure container may be mated with the female stacking structure of the second closure container .
Brief Description of the Drawings
Figure 1 is a perspective view of a first embodiment of a tamper evident closure container according to the present invention.
Figure 2 is a perspective view of the container shown in Figure 1 in an open state and holding a syringe.
Figure 3 is another perspective view of the container shown in Figure 1 in an open, empty state.
Figure 4 is a top plan view of the container shown in Figure 1.
Figure 5 is a bottom plan view of the container shown in Figure 1.
Figure 6 is a front elevation view of the container shown in Figure 1.
Figure 7 is a rear elevation view of the container shown in Figure 1.
Figure 8 is a right side elevation view of the container shown in Figure 1.
Figure 9 is a left side elevation view of the container shown in Figure 1.
Figure 10 is a top plan view of the container as shown in Figure 3.
Figure 11 is a bottom plan view of the container as depicted in Figure 3.
Figure 12 is a front elevation view of the container as shown in Figure 3.
Figure 13 is a rear elevation view of the container as depicted in Figure 3.
Figure 14 is a right side elevation view of the container as shown in Figure 3. Figure 15 is a left side elevation view of the container as depicted in Figure 3.
Figures 16-19 depict a progressive method of enclosing a syringe in the first embodiment of the container according to the present invention.
Figure 20 is a cross-sectional view along line 20-20 of Figure 19.
Figure 21 is a perspective view of a plurality of containers according to the first embodiment of the present invention stacked one on top of the other.
Figure 22 is a selected cut-away view of Figure
21.
Figure 23 is a perspective view of a second embodiment of a tamper evident closure container according to the present invention.
Figure 24 is a perspective view of a plurality of containers according to the second embodiment of the present invention stacked one on top of the other.
Figure 25 is a cut-away view of selected section Fig. 25 of Figure 24.
Description of the Preferred Embodiment
Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structures. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims .
Turning first to Figure 1, a first embodiment 10 of a closure container according to the present invention is shown. The closure container 10 preferably comprises a single injection-molded piece having a first casing member 100 hingedly attached to a second casing member 200 by at least one hinge 12 (see Figure 2), which may be a living hinge .
The first casing member 100 may generally be formed along a longitudinal length between and including a first end 102 opposite a second end 104, an outer surface 106, a peripheral edge portion 116 (Figure 2), a fastener 118, and an inner surface 132 (Figure 2) .
The outer surface 106 of the first casing member 100 extends from the first end 102 to the second end 104 and to the peripheral edge portion 116. The outer surface 106 has a planar portion 108 with a window 110 preferably provided therein and a plurality of catches 112 projecting therefrom.
Each catch 112 preferably has an L-shape profile and extends outward from the planar portion 108, whereby an arm 114 of the L-shape is spaced from and substantially parallel with the planar portion 108 of the outer surface 106, and all of the catches 112 are oriented preferably in the same direction.
The fastener 118 is flexibly connected at or near the peripheral edge portion 116 of the first casing member 100 opposite the hinge 12. The fastener 118 has a width 120, a thickness 122, an exterior surface 124, an interior surface 126, and a tamper-evident pull-tab 130. A barb 128 projects from the interior surface 126 distal to the outer surface 106 of the first casing member 100.
The tamper-evident pull-tab 130 preferably extends substantially perpendicular from the fastener 118 between the barb 128 and the outer surface 106 of the first casing member 100. The tamper-evident pull-tab 130 is preferably offset from the exterior surface 124 of the fastener 118 in a direction away from the container 10 when the fastener 118 is in an engaged position, as discussed further below.
The inner surface 132 of the first casing member 100 can be seen in Figures 2 and 3. The inner surface 132 extends from the first end 102 to the second end 104 and to the peripheral edge portion 116, and preferably has an at least substantially planar portion 134. As shown here, a bridge 136 with a notch 138 projects from the planar portion 134 of the inner surface 132 near the first end 102 to or near the peripheral edge portion 116.
A retainer 140 extends from the planar surface 134 to or near the peripheral edge portion 116 and comprises a first wall 142, with a first wall notch 144, and a second wall 146, with a second wall notch 148, substantially parallel to the first wall 142.
A plurality of dosing ribs 152 project from the planar portion 134 to or near the peripheral edge portion 116 and are spaced between the second end 104 and the second wall 146 of the retainer 140. Each dosing rib 152 has a notch 154, an innermost side 156 (hidden), and an outermost side 158. The spacing between the dosing ribs 152 relates to the predetermined dosage provided in a syringe 50 (Figure 2) to be contained within the closure container 10. The preferable dosing amounts for which the ribs 152 will be spaced are 0.25mL, 0.5mL, 0.75mL, and l.OmL, but other dosing amounts are contemplated.
The second casing member 200 may be seen in Figures 2 and 3 as well. The second casing member 200 has a first end 202 opposite a second end 204, an outer surface 206, a peripheral edge portion 216, and an inner surface 232.
The outer surface 206 of the second casing member 200 extends from the first end 202 to the second end 204 and to the peripheral edge portion 216. The outer surface 206 preferably has an at least substantially planar portion 208 with a plurality of holes 260 (Figure 5) therein which are sized, positioned, and configured to be mateable with the catches 112 of the first casing member 100 of another closure container 10. As shown in Figures 10 and 11, the outer surface 206 of the second casing member 200 has a recess 262 with a width 264 slightly greater than the width 120 of the fastener 118 and a depth 266 preferably similar to the thickness 122 of the fastener 118. A slot 268 sized and configured to receive the barb 128 of the fastener 118 is provided within the recess 268.
Looking back to Figures 2 and 3, the inside surface 232 of the second casing member 200 is shown. The inside surface 232 of the second casing member 200 is preferably substantially similar to the inside surface 132 of the first casing member 100. As shown here, the inner surface 232 extends from the first end 202 to the second end 204 and to the peripheral edge portion 216, and preferably has a planar portion 234. As shown here, a bridge 236 with a notch 238 projects from the planar portion 234 of the inner surface 232 near the first end 202 to or near the peripheral edge portion 216.
A retainer 240 extends from the planar portion 208 to or near the peripheral edge portion 216 and comprises a first wall 242, with a first wall notch 244, and a second wall 246, with a second wall notch 248, substantially parallel to the first wall 242. The first wall 242 is spaced apart from the second wall 246 a distance 250.
A plurality of dosing ribs 252 project from the planar portion 234 of the inner surface 232 to or near the peripheral edge portion 216 and are spaced between the second end 204 and the second wall 246 of the retainer 240. Each dosing rib 252 has a notch 254, an innermost side 256, and an outermost side 258. The spacing between the dosing ribs 252 relates to the predetermined dosage provided in a syringe 50 (Figure 2) to be contained within the closure container 10. The preferable dosing amounts for which the ribs 252 will be spaced are 0.25mL, 0.5mL, 0.75mL, and l.OmL, however, other dosing amounts are contemplated. Additionally or alternatively, the dosing ribs 152 of the first casing member 100 may be staggered from the dosing ribs 252 of the second casing member 200 to provide more dosing options while still providing secure support of the syringe 50 and the plunger 52.
Additionally or alternatively, the first casing member 100 or the second casing member 200 may not contain the respective dosing ribs, retainer, or the bridge; instead being configured simply to cover the other casing member 200,100.
Looking back to Figure 1 and also to Figures 4- 9, the closure container 10 is depicted in from various views with the syringe 50 positioned within the container 10 and the fastener 118 engaged with the second casing member 200. As shown, when the container 10 is in a closed position, the fastener 118 preferably resides substantially within the recess 262, with the barb 128 received within the slot 268.
The material from which the closure container 10 is formed is preferably initially transparent. The window 110 is preferably formed by covering the area in which the window 110 will be located, treating at least the outer surfaces 106,206 of the first casing member 100 and the second casing member 200, respectively, to decrease the transparency of those surfaces, and removing the covering to reveal the window 110. The treatment may be performed by any process now known or later discovered, including but not limited to, chemical etching, mechanical etching (e.g., sand blasting) , or during the molding process using textured dies .
Continuing to look at Figure 1, a syringe 50 can be viewed through the window 110 in a pre-set dosage configuration, ready for use. The window 110 is preferably located at least radially outward from the barrel 64 of the syringe 50 to provide a care provider with a view of the syringe 50 and preferably the dosage amount provided in the barrel 64 without having to open the closure container 10.
Directing attention to Figures 16-19, the installation of the syringe 50 into the container 10 is shown. Figure 16 illustrates the syringe 50 with a predetermined dosage provided in the barrel 64 prior to placement within the second casing member 200; however, the syringe 50 may be placed within the first casing member 100 as well, as shown in Figure 17.
Looking to Figure 17, with reference to Figure
16, the flange 60 of the syringe 50 is placed within the retainer 140 of the first casing member 100 with a portion of the barrel 64 received by the notch 144 of the first wall 142 and another portion of the barrel 64 received by the notch 138 of the bridge 136. Preferably, the distance 150 between the first and second walls 142,146 of the retainer 140 (Figure 10) is preferably slightly greater than the thickness 62 of the syringe flange 60.
The top 54 of the plunger 52 has a topside surface 56 and an underside surface 58. When installed within the container 10, the underside surface 58 of the syringe top 54 preferably resides against or near the outermost side 158 of the respective dosing rib 152. The placement of the flange 60 within the retainer 140 and the top 54 against the dosing rib 152 reduces the likelihood that the syringe 50 will be accidentally discharged prior to use.
Figure 18 illustrates the closing of the container 10 with the first and second casing members 100,200 rotating about the hinge 12 (Figure 17) and adjoining the first casing member peripheral edge portion 116 (Figure 17) with the second casing member peripheral edge portion 216 (Figure 17) . The barrel 64 of the syringe 50 is thereby also received within the bridge notch 238, the retainer 240, and the respective dosing rib notch 254 of the second casing member 200 (see Figure 17) .
Looking to Figures 19 and 20, the engagement of the fastener 118 is shown. The fastener 118 is wrapped around the outside surface 206 of the second casing member 200 within the recess 262. The barb 128 is engageably received within the slot 268 to retain the fastener 118 in the engaged position.
When the time comes for the syringe 50 to be removed from the container 10, the health care personnel will pull the tamper-evident pull-tab 130 away from the container 10 which will tear through the fastener 118 and sever the fastener's connection between the first and second casing members 100,200, thus allowing the container 10 to be opened and the syringe 50 to be removed.
Removal of the tamper-evident pull-tab 130 permanently detaches at least a portion of the fastener 118 from the first casing member 100 when pulled to gain access to the syringe 50. Therefore, tampering with the fastener 118 or the tamper-evident pull-tab in an attempt to gain access to the syringe 50 will be visibly noticeable by a tear in the fastener 118.
Figures 21 and 22 demonstrate how multiple containers 10A, 10B,10C may be stacked one on top of the other .
As shown in greater detail in Figure 22, a mateable stacking interaction between a catch 112A and a hole 260B is shown. The interaction allows the containers 10A, 10B to be removably interlocked. The catch 112A, along with the other three catches (not shown) , of the first container 10A are inserted within the holes 260B of the second container 10B and the containers 10A, 10B, are slid in opposite directions relative to one another to place the arm 114A of the first container 10A adjacent to the inner surface 232B of the second container second casing member 200B. These actions are depicted by the dashed lines in Figure 21.
Figure 23 illustrates a second embodiment 20 of the closure container according to the present invention. The closure container 20 has tabs 470 projecting from the planar portion 408 of the second casing member outer surface 406 and apertures 390 (Figure 24) provided through the planar portion 308 of the first casing member outer surface 306. The apertures 390 are alignable and mateable with the tabs 470 of a corresponding closure container 20.
Each tab 470 has a width 472 (Figure 24), an inward face 476, and an outward face 480. The tabs 470 preferably extend substantially perpendicular away from the outside surface planar portion 408 and comprise a protuberance 478, or similarly shaped protrusion, on the inward face 476 at or near the distal end portion 482 (Figure 25) of each tab 470. Alternatively, it is contemplated that the protuberance 478 may protrude from the outward face 480.
The apertures 390 have a width 392 and an abutting surface 396. The width 392 of the apertures 390 is preferably slightly greater than the width 472 of the tabs 470.
Figures 24 and 25 demonstrate how multiple containers 20A, 20B,20C may be stacked by inserting the tabs 470B of a second container 20B within the apertures 390A of a first container 20B. This action is depicted by the dashed lines in Figure 24. In this fashion, stacking of these embodiments 20 require only a singular directional movement, rather than the compound movement that may be utilized to stack cases according to the first embodiment 10.
Figure 25 more closely illustrates the interaction between a tab 470B of the second container 20B is received within an aperture 390 of the first container 20A to provide a releasable connection between the two containers 20A, 20B. Preferably, the inner face 476B of the tab 470B is substantially flush with the abutting surface 396A of the aperture 390A, whereby the protuberance 478B of the tab 470B is in contact with the planar portion 334A of the first casing member inner surface 332A and the first container's second casing member outer surface planar portion 308A is flush with the second container's first casing member outer surface planar portion 408B.
The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.
We Claim:
1. A tamper evident closure container comprising :
a first casing member and a second casing member, the second casing member having an inner surface with a plurality of transverse dosing ribs, a bridge, and a retainer projecting therefrom that are configured to cradle a syringe containing a predetermined amount of fluid;
a fastener having a tamper-evident pull-tab, the fastener being connected to one of the first casing member and the second casing member and configured to releasably maintain closure of the container; and
a female stacking structure formed on one of the first casing member and the second casing member and a male stacking structure formed on the other of the first casing member and the second casing member.
2. The tamper evident closure container of claim 1, wherein

Claims

the female stacking structure comprises a plurality of holes provided in the one of the first casing member and the second casing member; and
the male stacking structure comprises a plurality of catches protruding from the other of the first casing member and the second casing member in an orientation and spacing commensurate with the plurality of holes.
3. The tamper evident closure container of claim 2, wherein each of the plurality of catches has an arm extending substantially parallel with and spaced from a planar portion of an outer surface of the other of the first casing member and the second casing member.
4. The tamper evident closure container of claim 1, wherein
the female stacking structure comprises a plurality of holes provided in the one of the first casing member and the second casing member; and
the male stacking structure comprises a plurality of tabs extending substantially perpendicularly from an outer surface of the other of the first casing member and the second casing member, the tabs being arranged in an orientation and spacing commensurate with the plurality of holes.
5. The tamper evident closure container of claim 4, wherein each tab has a protuberance spaced from the outer surface of the other of the first casing member and the second casing member by a distance substantially equivalent to a thickness defined between and including an inner surface and an outer surface of the one of the first casing member and the second casing member.
6. The tamper evident closure container of claim 1, wherein
the fastener depends from the first casing member and comprises a barb; and
the second casing member comprises a slot in which the barb is receivable.
7. The tamper evident closure container of claim 1, wherein the first casing member further comprises:
an inner surface with a plurality of transverse dosing ribs, a bridge, and a retainer projecting inwardly therefrom and configured to at least partially surround the syringe .
8. The tamper evident closure container of claim 7, wherein the transverse dosing ribs of the first casing member are longitudinally offset from the transverse dosing ribs of the second casing member.
9. The tamper evident closure container of claim 1, wherein each transverse dosing rib is placed to correspond to a different selected predetermined amount of fluid in the syringe.
10. The tamper evident closure container of claim 9, wherein the predetermined amount of fluid is selected from the group of fluid measurements consisting of 0.25 mL, 0.5 mL, 0.75 mL, and 1.0 mL .
11. The tamper evident closure container of claim 1, further comprising:
a window surface formed on one of the first casing member and the second casing member, wherein the window is formed on the first casing member by:
masking a window portion of the first casing member with a mask material;
surface treating at least a portion of each of the first casing member and the second casing member; and removing the mask material from the window portion .
12. The tamper evident closure container of claim 11, wherein the window surface is positioned on the container to enable visual access to a barrel of a retained syringe .
13. The tamper evident closure container of claim 1, wherein the container is formed as a unitary injection-molded piece, and the first casing member and second casing member are hingedly connected by a living hinge .
14. A system for retaining syringes comprising :
a first closure container according to claim 1; and
a second closure container according to claim
1,
wherein the male stacking structure of the first closure container is mated with the female stacking structure of the second closure container.
PCT/US2015/064707 2015-01-16 2015-12-09 Tamper evident closure container WO2016114867A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
NZ731002A NZ731002A (en) 2015-01-16 2015-12-09 Tamper evident closure container
CA2967041A CA2967041C (en) 2015-01-16 2015-12-09 Tamper evident closure container
AU2015377191A AU2015377191A1 (en) 2015-01-16 2015-12-09 Tamper evident closure container
EP15878277.1A EP3244942B1 (en) 2015-01-16 2015-12-09 Tamper evident closure container
ES15878277T ES2825654T3 (en) 2015-01-16 2015-12-09 Tamper-proof closure container
AU2020230336A AU2020230336B2 (en) 2015-01-16 2020-09-11 Tamper evident closure container

Applications Claiming Priority (2)

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US14/599,202 US9333289B1 (en) 2015-01-16 2015-01-16 Tamper evident closure container
US14/599,202 2015-01-16

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WO2016114867A2 true WO2016114867A2 (en) 2016-07-21
WO2016114867A3 WO2016114867A3 (en) 2016-10-27

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US (5) US9333289B1 (en)
EP (1) EP3244942B1 (en)
AU (2) AU2015377191A1 (en)
CA (1) CA2967041C (en)
ES (1) ES2825654T3 (en)
NZ (1) NZ731002A (en)
WO (1) WO2016114867A2 (en)

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US20190328956A1 (en) 2019-10-31

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