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
  • B65D50/00—Closures with means for discouraging unauthorised opening or removal thereof, with or without indicating means, e.g. child-proof closures
  • B65D50/02—Closures with means for discouraging unauthorised opening or removal thereof, with or without indicating means, e.g. child-proof closures openable or removable by the combination of plural actions
  • B65D50/04—Closures with means for discouraging unauthorised opening or removal thereof, with or without indicating means, e.g. child-proof closures openable or removable by the combination of plural actions requiring the combination of simultaneous actions, e.g. depressing and turning, lifting and turning, maintaining a part and turning another one
  • B65D50/041—Closures with means for discouraging unauthorised opening or removal thereof, with or without indicating means, e.g. child-proof closures openable or removable by the combination of plural actions requiring the combination of simultaneous actions, e.g. depressing and turning, lifting and turning, maintaining a part and turning another one the closure comprising nested inner and outer caps or an inner cap and an outer coaxial annular member, which can be brought into engagement to enable removal by rotation
• • 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
  • B65D50/00—Closures with means for discouraging unauthorised opening or removal thereof, with or without indicating means, e.g. child-proof closures
  • B65D50/02—Closures with means for discouraging unauthorised opening or removal thereof, with or without indicating means, e.g. child-proof closures openable or removable by the combination of plural actions

Definitions

• the invention relates to improvements to child-resistant closures for dispensers of liquid medicaments, in particular dispensers of liquid ophthalmic and nasal medicaments, and thereby provides enhanced safety of the dispensers by making the contents of the containers less susceptible to access by children.
• Child-resistant caps for medicaments have been known in the art for nearly fifty years. These caps generally require two opposed movements acting at the same time to overcome the locking mechanism. For example, one type of cap requires a user to squeeze the cap at specific points, causing a deformation, and then to rotate the cap. If either the squeezing or rotating step is not performed, the cap cannot be opened.
• Another common method for imparting child-resistance on a cap is to require that the cap be pushed in a downward direction and then turned in order to be removed. Again, it can be seen that the two movements are opposed to one another; it is only through application of this unnatural combination of movements that the cap can be removed.
• Such a cap is disclosed in U.S. Patent 5,316,161.
• the deformed or broken lugs, beams, or fingers may no longer exert a contrary or biasing force on other component parts of the cap. In such situations, no downward force is necessary for removal, leaving only a rotational force required to remove the cap. Therefore, the cap is no longer child- resistant.
• prior art caps often permitted an outer cap to float above and rotate unhindered about an inner cap until the application of a downward force.
• a major complaint of child-resistant caps has been that they are difficult for the elderly and infirm to remove.
• the elderly often have a difficult time applying the appropriate amount of downward force necessary to get the appropriate lugs, beams, or fingers to engage.
• the elderly often have a difficult time maintaining the appropriate downward force throughout the rotational movement.
• this lack of coordination and partial engagement would result in frustration on the part of the user.
• Redoubled efforts often resulted in damage to the elements of the cap, through the combination of improper alignment and application of excess force, albeit briefly applied. This was manifested in the crushing of certain portions or the stripping of others.
• Such damage includes, but is not limited to, deformation or breakage of the lugs, beams, or fingers, as well as crushing of other various critical components of the cap.
• a cap which reduces potential for damage to component parts through full engagement of lugs, beams, or fingers, (2) prevents over-flexion of lugs, beams, or fingers, (3) modifies the shape of lugs, beams, or fingers, (4) allows the elderly to more easily remove the cap, (5) provides for easier application of the cap by manufacturing processes while at the same time reducing the likelihood of damage to the cap, and (6) minimizes the amount of residual medicament accessible to a child in possession of the removed cap.
• the present invention provides an improved child-resistant closure for liquid ophthalmic and nasal medicaments, as well as a system for providing child-resistant closure of an existing bottle, and a method of application and removal, providing ease of application during the bottling phase and enhanced child-resistant properties once the apparatus and system have been distributed to an end user.
• One embodiment of the closure provides for a cap with matching numbers of complementary lugs and beams, with the flexible beams having an angled ridge with an arcuate underside. Additional embodiments of the closure include the requirement that an underside of an upper lug overlap a lower flexible beam by a predetermined distance or range of distances when the lug faces of upper lugs are properly aligned. These embodiments improve upon the reliability of a child-resistant closure by ensuring that it is only engaged when properly aligned, providing ideal frictional contact, and preventing undue stress upon the flexible beams when a downward force has been applied to them. Additional embodiments include modifications to a top portion of the cap, wherein one embodiment provides for a flat top and an alternative embodiment provides for a shaped top,
• An additional embodiment of the invention is a system in which flexion of the flexible beams is limited such that the beam head does not extend below the beam base of an adjacent flexible beam. By limiting such flexion, the beams are not damaged by hyper- flexion. The prior art does not address this issue, and by permitting beams to be
• the final embodiments of the invention relate to methods for attaching and removing the closure from a bottle containing liquid medicaments.
• the steps of applying a downward force and rotating the outer cap are sequential.
• the steps are simultaneous.
• the present invention advantageously eliminates the requirement of a constant downward force, such elimination being beneficial for elderly populations or those with arthritis.
• the final embodiment of the invention relates to the manner in which the invention is affixed to a bottle containing liquid medicaments. In this embodiment, no downward force is necessary.
• the present method is advantageous in that it does not require a re-tooling of present cap-applying machinery which lack the ability to exert a downward force.
• Figure 1 shows the improved child-resistant cap.
• Figures 2A-2C show multiple views of the outer cap.
• Figures 3A-3C show multiple views of the inner cap.
• Figures 4A-4B show a cap with top sections complementary to the shape of a dispenser nozzle for liquid medicaments affixed to a pre-existing bottle.
• Figure 5 shows the overlap of the skirt lug with the flexible beams when lug faces of the shoulder lugs are aligned.
• Figures 6A-6C shows the movements of the skirt lugs of the outer cap and the flexible beam of the inner cap as the outer cap is rotated counter-clockwise relative to the inner cap.
• Figure 7 shows the flexible beam when the lug faces of the shoulder lugs of the inner and outer caps have been aligned and a downward force has been applied to the outer cap.
• Figure 8 shows engagement of the flexible beam and the skirt lugs required to thread the cap onto a bottle.
• overlap shall be understood to mean the horizontal distance measured from the vertical plane of a lug face of a skirt lug to the vertical plane of the nearest beam face of a flexible beam, when the lug faces of shoulder lugs on inner and outer caps are aligned.
• lug shall be understood to include both male lugs and female lugs.
• discussion of "lugs” engaging one another shall be understood to include complementary male and female lugs engaging one another, two or more male lugs engaging one another, as well as two or more female lugs engaging one another.
• discussions of flexible beams engaging lugs shall be understood to include engagement of male or female lugs by a flexible beam.
• depth when referring to lugs, shall be understood to be a measure of the change in vertical length between a first end and a second of a lug.
• depth shall be understood to be a measure of the trough created by second end of the lug.
• depth shall be understood to be a measure of the peak created by the second end of the lug. The term “depth” has been selected because in the
• shoulder lugs of the outer cap are male and extend in a downward direction, where they mate with female shoulder lugs of the inner cap.
• depth is not limited to such male-to-female engagements nor to the relative directions depicted in the figures.
• the present invention may be constructed of any one of a number of polyolefins, including but not limited to polypropylene, as well as high- , medium- , and low- density polyethylene. These materials are known for their critical mechanical properties including, but not limited to, their flexural modulus, tensile strength, and elongation, and with the benefit of the present disclosure, one of ordinary skill in the art would understand that other materials exhibiting the same properties could be used in the construction of the cap, and therefore the invention is not limited to embodiments constructed of the materials listed above, but is intended to include all materials, whether presently known or developed in the future, which may exhibit similar structural properties.
• the child-resistant cap 100 is of a two-part construction, with an outer cap 101 and an inner cap 102.
• outer cap 101 has a top portion 103 which is adjacent to depending skirt 104.
• depending skirt 104 contains a gripping surface 105, which may be defined by ridges, dimples, cross-hatching, or any other mechanism or method known to one skilled in the art to increase the friction between the hand of a user and outer cap 104.
• gripping surface 105 embodied in the form of ridges
• the invention is not so limited, and it is contemplated that in alternative embodiments, the materials used in the construction of outer cap 101 will provide adequate friction and gripping capabilities for a user, and thus no independent gripping surface 105 may be present.
• outer cap 101 also has an internal chamber
• the shape of internal chamber 106 includes shoulder 107, on which is mounted a quantity of shoulder lugs 108.
• Shoulder lugs 108 have a first end 109 and a second end 110.
• the depth of shoulder lugs 108 increases from first end 109 to second end 110.
• the depth of shoulder lugs 108 may be varied to suit the specific needs of the enclosure, and with the benefit of the present disclosure, one skilled in the art would be enabled to tailor the depth of shoulder lugs appropriately. In one embodiment, the depth of shoulder lugs 108 ranges from between 0.015 to 0.040 inches, although the present invention is not limited to this embodiment.
• Second end 110 has a lug face 111, oriented perpendicular to the longitude of shoulder lug 108 and distal to first end 109. Further, the orientation of each lug face 111 is common, providing for a common rotational direction. That is to say, when each lug face 111 is acted upon by another object, the direction of action provides for a consistent rotational action around a central axis.
• second end 110 also includes a bottom surface extending parallel to the longitude of shoulder lug 108 and providing for a ninety- degree or "right angle" transition from second end 110 to lug face 111.
• Internal chamber 106 is further defined by an annular ridge 112 located at a predetermined distance from shoulder 107.
• the distance between shoulder 107 and annular ridge 112 is greater than the height of shoulder lugs 108, and with the benefit of the present disclosure, one skilled in the art would be enabled to tailor the distance between shoulder 107 and annular ridge 112 as required for the size and shape of the bottle and closure in question. In one embodiment, this may range from 0.562 to 0.576 inches, although the present invention is not limited to this embodiment.
• Annular ridge 112 contains a quantity of skirt lugs 113.
• skirt lugs 113 have a first end 114 and a second end 115, with second end 115 having a lug face 116.
• Lug faces 116 are oriented perpendicular to the longitude of skirt lug 113 and distal to first end 114. Further the orientation of each lug face 116 is common, such that when each lug face 116 is acted upon by another object, a common rotational direction is achieved, providing for rotation about a central axis. However, the orientations of lug faces 116 is opposite that of the orientations of lug faces 111.
• Second end 115 also has bottom surface 117, oriented distal to top portion 103.
• Outer cap 101 also includes an assembly retaining bead 130 located within internal chamber 106 at a location distal to both shoulder 107 and annular ridge 112. In one embodiment, assembly retaining bead 130 is located a distance inward from open end 131 of outer cap 101. In an alternative embodiment, assembly retaining bead 130 is located at open end 131. [0032] Outer cap 101 is capable of vertical movement relative to inner cap 102. In one embodiment depicted by the figures, the vertical downward travel distance of outer cap 101 relative to inner cap 102 is 0.067 inches, although the present invention is not so limited. Indeed, with the benefit of this disclosure, one skilled in the art would be enabled to determine the appropriate downward travel for bottles of varying sizes, as may be required by product specifications set forth by the manufacturer.
• inner cap 102 has a top portion 118, a shoulder
• FIG. 3A depicts a quantity of shoulder lugs 120 mounted on shoulder 119.
• Shoulder lugs 120 have a first end 121 and a second end 122.
• Second end 122 has a lug face 123 located distal to first end 121 and oriented perpendicular to the longitude of shoulder lugs 120. The orientation of lug faces 123 is common, such that when each lug is acted upon by another object, common rotational direction is achieved, providing for rotation about a central axis.
• the orientation of lug faces 111 is complementary to the orientation of lug faces 123 to provide for engagement of one lug face by the opposing lug face.
• the depth of shoulder lugs 120 ranges from between 0.015 to 0.040 inches, although the present invention is not limited to this embodiment.
• depending skirt 124 has a quantity of flexible beams
• Each flexible beam 125 consists of a beam base 126 and a beam arm 127.
• Beam arm 127 has an angled ridge 128 which terminates in a beam head 129.
• Beam base 126 has an upper face 133 and a leading face 134.
• Angled ridge 128 has a top side 135 and an underside 136. Angled ridge 128 is connected to beam base 126 such that top side 135 extends from upper face 133 and underside 136 extends from leading face 134.
• Underside 136 extends from leading face 134 in an arcuate or radiused manner.
• flexion or deformation takes place along angled ridge 128.
• the construction of flexible beam 125 is such that it has a resiliency which permits for it to return to its original shape and location when the downward force is no longer applied.
• underside 136 consists of an arcuate or radiused portion 137 adjacent to a straight portion 138.
• underside 136 consists entirely of an arcuate or radiused portion 137.
• Beam head 129 has an upper surface 139 and a beam face 140.
• the radius of arcuate or radiused portion 137 is 0.065 inches, although the invention is not so limited. With the benefit of the present specification, one skilled in the art would understand that any radius up to and including a radius of 0.095 inches could be utilized. Indeed, as the materials used in the construction of flexible beam 125 vary, different radii may be necessary to provide for maximum resiliency of flexible beam 125 while at the same time ensuring that downward forces exerted upon flexible beam 125 do not result in the deformation of flexible beam 125 in a vector oriented radially to a central axis.
• Beam faces 140 are located distal to beam base 126 and have an orientation permitting for a common rotational direction about a central axis, such that force imparted on any beam face 140 will result in inner cap 102 rotating in the same direction about a central axis.
• the orientation of beam faces 140 is complementary to the orientation of lug face 116, and correspondingly the common rotational direction of beam faces 140 is complementary to the common rotational direction of lug faces 116.
• the quantity of shoulder lugs 108 must be equivalent to the quantity of shoulder lugs 120. Additionally, the quantity of skirt lugs 113 must be equivalent to the quantity of flexible beams 125. Equivalent quantities provide for maximum engagement of lugs and complementary lugs and/or beams. Additionally, equivalent quantities of shoulder lugs 108, shoulder lugs 120, skirt lugs 113, and flexible beams 125 provide for maximal engagement of outer cap 101 with inner cap 102. As such, in one embodiment, the quantity of shoulder lugs 108 is equal to the quantity of shoulder lugs 120 and the quantity of skirt lugs 113 is equal to the quantity of flexible beams 125.
• the quantities of shoulder lugs 108, shoulder lugs 120, skirt lugs 113, and flexible beams 125 are all equal.
• Traditional closure mechanisms have permitted unequal numbers of complementary lugs and or beams; such as six lugs designed to be complementary mates to eight fingers. These unequal quantities result in an increased chance of slippage between beams and lugs, and such slippage can result in damage to the flexible beams themselves, including permanent upward or downward deformation of the beams or crushing of the lugs, leading to a decrease in, or even full elimination of, the child-resistant nature of the two-part closure.
• inner cap also has an internal cavity 141 defined by the internal surfaces of top portion 118, shoulder 119, and depending skirt 124.
• the internal surface of depending skirt 124 is configured with threads 142 to permit attachment of the cap to a pre-existing bottle with complementary, mated threads on its neck face.
• top portions 103 and 118 are flat and do not extend above shoulder 107 and 119 respectively.
• Figures 4A-4B depict cap 100 when it is attached to a pre-existing bottle.
• Figure 4A shows the outer view of cap 100 when it is attached to a pre-existing bottle.
• Figure 4B shows a cross-sectional view of cap 100 attached to a bottle, with top portions 103 and 118 extending above and away from shoulder 107 and shoulder 119 respectively.
• top portions 103 and 118 have a shape which is complementary to the shape of a dispenser nozzle for liquid medicaments. This complementary shape provides for an extra level of safety with regard to access of the medicament by a child.
• flat top portions 103 and 118 when cap 100 is affixed to a bottle of liquid medicaments and the bottle is inverted, there is the potential for liquid to flow out of the bottle and pool within the area created by the internal cavity of inner cap 102.
• Embodiments containing such an extruded shape complementary to the shape of a nozzle of a dispenser of liquid medicaments significantly reduce the overall volume of the cap cavity by more closely approximating the size and shape of the dispenser nozzle.
• the embodiment depicted in the Figures reduces the likelihood of accidental overdose by children who ingest residual medicament from a cap which has been removed from the dispenser.
• FIG. 5 Another feature of the present invention involves the spatial relationship of shoulder lugs 108 and 120 as they relate to skirt lugs 113 and flexible beams 125.
• Figure 5 demonstrates the overlap exhibited by skirt lugs 113 and flexible beam 125 when lug faces 111 and 123 are aligned.
• the overlap is a predetermined horizontal distance of 0.019 inches, although the present invention is not so limited, and alternative embodiments include overlaps in a variety of ranges.
• the range for predetermined horizontal distances of overlap is between 0.016 and 0.022 inches.
• the range for overlap distance as between 0.013 and 0.025 inches.
• An additional benefit of the present invention relates to the interaction between shoulder lugs 108, flexible beams 125, and assembly retaining bead 130.
• flexible beams 125 have a resiliency which allow them to be deformed when a downward force is applied and then return to their original shape and location when the downward force is removed. This resiliency provides an upwards biasing force on shoulder lugs 108. This upward biasing force is counteracted by assembly retaining bead 130, in that assembly retaining bead 130 prevents the upward biasing force exerted on shoulder lugs 108 by flexible beams 125 from detaching outer cap 101 from inner cap 102 entirely.
• outer cap 101 rises and falls vertically with respect to inner cap 102, in a ratcheting motion when it is rotated in this manner.
• This position is the optimal deformation of flexible beam 125, does not travel below the bottom of the adjacent beam base 126. Further, this downward force deforms or flexes angled ridge 128 such that angled ridge becomes approximately parallel with the adjacent beam base 126 when beam head 129 is at its lowest position.
• hyper-flexion of flexible beam 125 can be prevented. This is advantageous, because hyper-flexion can result in a loss of resilience of flexible beam 125. When resilience is lost, an active downward force is no longer required to engage lug face 111 of shoulder lug 108 with lug face 123 of shoulder lug 120. When the downward force is no longer required, the cap has lost its child-resistant nature.
• the design of the present invention represents an improvement upon prior art, in that it eliminates hyper-flexion, and thus preserves the child-resistant nature of the cap; while the prior art, lacking such a defined spatial limitation on flexion, permits hyper-flexion and its resultant damage to flexible beam 125 and loss of child-resistant functionality.
• closure described above is designed to be applied to pre-existing bottles for liquid medicaments. It is understood that these bottles will already have threads provided on their neck finishes.
• cap 100 has been affixed to the pre-existing bottle.
• no additional downward force is required to apply cap 100 to the pre-existing bottle.
• the engagement of threads 142 with the threads of the pre-existing bottle will impart a downward force on the cap 100 and cause it to travel downwards relative to the pre-existing bottle.
• this downward force is the mechanical result of the engagement of threads 142 and is not imparted directly by the user. This represents a benefit over the prior art in that present machinery which is only capable of imparting a rotational direction may be used to affix cap 100 to a bottle - there is no re-tooling of the machine necessary.
• Removal of the cap is effected thusly: a downward force is applied upon outer cap 101, moving it in a downward direction relative to inner cap 102. A rotational movement is then applied to outer cap 101 in a removal direction about a central axis relative to inner cap 102, the direction most commonly being counter-clockwise. Rotation of outer cap 101 is continued until shoulder lugs 108 engage shoulder lugs 120. Rotation of outer cap 101 continues, and the rotational force is transferred to inner cap 101 due to the engagement of shoulder lugs 108 with shoulder lugs 120. This continued rotation permits outer cap 101 and inner cap 102 to rotate in concert about a central axis. This rotation of inner cap 102 begins to disengage threads 142 from the threads of the pre-existing bottle.
• the user may optionally cease applying a downward force on outer cap 101.
• This option is available to the user because the flexible beam 125 will impart an upward biasing force on outer cap 101; at the same time, the placement of assembly retaining bead 130 will maintain contact between bottom surface 117 of skirt lugs 113 and the angled ridge 128 and beam head 129 of flexible beam 125. This contact results in friction which continues to transfer the rotational force imparted on outer cap 101 to inner cap 102.
• maintained rotation of outer cap 101 will result in concerted rotation of inner cap 102 despite the fact that shoulder lugs 108 may no longer be engaging shoulder lugs 120.
• the rotational force continues to be applied to outer cap 101 and transferred to inner cap 101 until threads 142 are fully disengaged from the threads of the pre-existing bottle. At this point the cap may be lifted from the pre-existing bottle.
• the method described above is particularly advantageous for the elderly, as it only requires the downward force to be applied until the torque needed to overcome the static frictional forces between threads 142 and the threads of the bottle has been overcome; it requires the two-directional movement necessary to ensure child-resistance, but by permitting only single-directional movement at later stages of removal, ease of use is increased for those who have decreased coordination or strength due to advanced age and infirmity.
• first step of applying a downward force and the second step of applying a rotational force may be reversed, such that the rotational force is applied first and the downward force is applied second.
• first two steps of applying a downward force and applying a rotational force are combined into a single step wherein the downward and rotational forces are applied simultaneously.

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• Engineering & Computer Science (AREA)
• Mechanical Engineering (AREA)
• Closures For Containers (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)

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• 2013
  • 2013-07-12 US US13/940,666 patent/US20140014611A1/en not_active Abandoned
  • 2013-07-12 EP EP13816761.4A patent/EP2872415B1/en active Active
  • 2013-07-12 CN CN201380045795.1A patent/CN104603017B/zh active Active
  • 2013-07-12 MX MX2015000555A patent/MX367823B/es active IP Right Grant
  • 2013-07-12 JP JP2015521833A patent/JP6322352B2/ja active Active
  • 2013-07-12 WO PCT/US2013/050220 patent/WO2014011965A1/en active Application Filing
  • 2013-07-12 CA CA2879081A patent/CA2879081C/en active Active

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