1. Field of the Invention
The purpose of this improved novel apparatus is to provide pharmacies with a less costly child resistant tamper evident closure for faster filling of prescription drugs into a LID-LESS all plastic, squeeze-to-open, self-closing airtight pill-box, which always stays closed, unless re-opened by squeezing, thereby preventing withdrawal ofpills by children or entry of contaminants, moisture, germs, bugs etc. Using the LID-LESS pill-box, not only eliminates seal caps and usual storage and handling problems, but provides a simple and positive way to form a child resistant tamper evident closure by merely overlapping the outlet lips of said lid-less pillbox with a modified version of the bar coded self-adhesive paper label portion shown on the 8½″×11″ computer formats presently used by pharmacies, thereby providing the pharmacist with an in-house tamper evident lip seal closure, and the consumer, at-home protection against tampering by children.
Samples of the LDPE plastic pill-box along with copy of this patent's preceding provisional application No. 60/553,327 (filing date Mar. 16, 2004) were sent to FDA's Consumer Product Safety Commission for acceptance in pharmaceutical prescription packaging applications. Obviously, this improved apparatus can be used for other than pharmaceutical products. Details, along with an alternate tack-welded, indented lip seal tamper evident closure for larger multi-purpose pouches, are described hereinafter
2. Description of the Prior Art
Prior art for overlapping the outlet lips of a lid-less pillbox using present pharmaceutical type prescription self adhesive paper labels to form a child resistant tamper evident closure as proposed herein, appears to be non-existent, however, prior art does exist for my “Self-Closing Valve With Tamper Evident Lip Seal Tab” per U.S. Pat. No. 4,917,267 conceived, designed and built from standard cylindrical plastic bottles with conventional threaded outlets, made from flexible LDPE, Low Density Polyethylene Chevron PE5104 resin. The bottles were cut at the shoulder line for removal of the threaded outlet nipple, to form t vial having an opening the same as that of the bottle width diameter for easy clamping, heating and post-forming of the novel squeeze-to-open, self-closing elongated curved outlet lips. The unit was market tested at local pharmacies, for direct purchase by customers; not by pharmacists for prescription filling, as proposed herein. Initially, the tests showed a demand for the novel self-closing pill-box. Later on however, repeat orders were limited because of the durability of the self-closing outlet with a life expectancy of 5 to 10 years. As presently produced, the squeeze-to-open, self-closing dispenser is too costly to replace present drug store prescription bottles; therefore this patent application with novel cost reduction improvements described in the Summary of the Invention.
The possibility of infringements were abandoned after review of the prior arts listed in U.S. Patent Documents references cited in U.S. Pat. No. 4,917,267 (LAVERDURE). Please note most of the listed prior art references are for storing liquids in thin plastic film bags, except one for viscous material per U.S. Pat. No. 3,773,233 (SOUZA) in a containers and another U.S. Pat. No. 3,342,318 (RUEKBERG) for restricted flow, gasket sealed, single tablet dispenser without tamper evident or child resistant protection, whereas the pill-box of this invention pertains to dispensing various products, in various amounts without restriction to flow; and provided with tamper evident and child resistant dispensing. Subsequent to the above, U.S. Pat. No. 5,727,593 (DUER) discloses a cylindrical bottomless apparatus (not intended for storing products) used only as a self-closing valve, having a curved elongated outlet exactly as defined in LAVERDURE's U.S. Pat. No. 4,917,267 but made of different material and for different purpose i.e. to prevent back-flow into city streets from flooded rivers that may be built as six feet or more in diameter, and therefor not intended to be built as a squeeze-to-open portable hand held container.
The following describes what is considered to be improvements over prior art.
The experience gained making and selling the Lid-less elongated curved outlet dispensers, per my previous aforementioned patent, ascertains they could be formed in an even simpler, more effective and economical manner per the following.
Instead of post-forming the elongated curved outlet from precut plastic bottles, make said elongated curved outlet integrally, as part of the original item. The mold for making said item shall be cored for cooling according to conventional practice, and heated for melting the plastic resin to form said Lid-less pill-box's cylindrical walled outlet until it outwardly tapers to an adjoining, widened, flattened, smooth curved quadrant slot; said discharge slot having opposed nested walls substantially in face to face contact when self-closing into its normal position, said curved discharge slot retains its structural shape and self-closing by cooling and compression prior to release from the mold used for thermoforming, said opposing walls of the curved quadrant discharge slot have a thickness to insure self-closing snap-back stress upon application of digital force at the exterior of the broadened outwardly tapering sides adjoining the widened, flattened curve discharge slot portion of the self-closing Lid-less pill-box.
Blow-molding appears to be the preferred method for forming the nested curved portion of the elongated airtight closure using, A/ mechanical means, such as adjustable clamps for compressing the remaining free space between the curved male and female lip portions, formed within the mold housing from 212F to ambient temperature, or B/ eject said unsealed curved elongated outlet, for post forming and final compression using Vertrod, or equal electric impulse water cooled heater or C/ apply ambient 15 psi atmospheric air for compressing said curved outlet into a nested airtight closure while under vacuum per the following:
Apply vacuum within said pill-box's chamber walls, to cause standard 15 psi external atmospheric air to compress the outer portions of the male and female elongated curved outlet lips into a nested self-closing airtight closure, at 212 F the softening point of LDPE. Vacuum may be obtained by using 5 psi steam, at the final stage of the blow-molding cooling cycle to maintain the 212F softening point temperature of LDPE, and for condensing said steam by heat transfer via the blow-molding cooling water. A compression time of 4 seconds at 212F is required for shaping, and 2 seconds cooling time at ambient temperature for establishing a permanent set or shape for the Lid-less elongated curved outlet, before release from the blow mold housing. External air may be introduced within the blow mold housing via the clamping device normally used to cut-off the paragon. Initially, the usual blow mold compressed air temperature of 350F is used for melting the LDPE plastic resin, at which point 125 psi high pressure steam is injected until the blow mold cooling temperature reaches 212F, at which point the compressed air blowing stream is shut-off and high pressure 125 psi steam pressure is reduced to 5 psi, for maintaining the mold temperature at 212F the softening point of LDPE, while shaping the elongated curved outlet during said 5 psi steam condensation. The advantages doing the above are: a/ uses less plastic material b/ uses less labor and tools, eliminates the saw cutting and clamping for reshaping the outlet neck portion of the aforementioned plastic flexible bottles, c/ the condensed low pressure steam creates a sanitized germ free airtight closure upon release from the mold.
d/ should inspection reveal insufficient “snap-back” in the self-closing elongated curved outlet, rather than recycling through the blow molder, such can be corrected by clamping the curved portion of the elongated outlet into a modified Vertrod model 4H or equal, electric impulse heater which can be provided with water cooling. Further major advantages are gained when using the novel elongated curved airtight closure, rather than conventional cylindrical outlets:
A/ Said novel tamper evident closure eliminates caps and their storage and handling problems, and the integrally molded lip seal tab shown on my my U.S. Pat. No. 4,917,267.
B/ A much simpler tamper evident closure is obtained by merely overlapping a portion of the typical 8½″×11″ self-adhesive prescription label used by pharmacists, over the pill-box's air tight curved elongated outlet shown in drawings Sheet 2 and 3; said closure is more child resistant, and much simpler to manipulate, than the usual snap-on child resistant cylindrical cap.
The cost for making this novel pill-box can possibly be paid within one year, from repeat sales of a portion of the nation's 55,000 drug stores that normally average 1000 prescriptions per week, half requiring 2 ounce and under size pill-boxes. Assuming a profit of one cent per pill box when selling to only 27,000 drug stores could yield seven million dollars per year.
Adhering to the same LDPE plastic material, wall thickness, outside diameter and inside radius of the elongated curved outlet slot used for making the original patented self-closing dispenser, guarantees an improved Lid-less pill-box, as summarized below:
1/ The closure lips of the Lid-less elongated curved dispenser outlet, when at ambient temperatures, maintains a dust and air-tight seal for several years. They withstood an original test of 1000 continuous opening and closing cycles.
2/ The standard natural finish of LDPE plastic, has an opaqueness that resists ultra-violet rays better than the amber colored vials used by pharmacies.
3/ LDPE plastic can be tinted using BPI molecular catalytic pink, made by Brain Power, Inc. Additives such as Titanium Dioxide can not be used for coloring, it will negate the plastic's flexibility and “snap-back” needed for self-closing.
4/ The {fraction (1/32)} inch wall thickness and the {fraction (9/32)} inch inside radius of the curved quadrant elongated outlet, normally used for effortless squeezing, can be altered for making it easier to open for arthritics, or more difficult for children, by lengthening the radius and/or thinning the wall for arthritics, and conversely for children. The method of applying prescription adhesive labels as heretofore mentioned and detailed in
5/ The dispenser outlet, may be made liquid tight, depending on conditions, such as viscosity, porosity, differential pressure via air-transport etc., by providing a separate elongated slip-on compression clip, to fit over and compress the flexible nested lips of the elongated curved dispenser outlet, when in the closed position.
6/ For small volume business the packaging supplier may use a simple hot water bath and vise clamping tool for shaping and compressing the outlet walls of a plain vial to form contact with one another into a curved elongated outlet for immersion in the hot water bath, at the plastic's softening point for several seconds; then dip in max. 90 F temperature water for establishing its set shape, for a few seconds, prior to release from the clamping tool.
7/ For item 6 above consider converting existing molds, used for plastic bottles such as Classic Containers, Inc.'s Item no. 010300-022001 One Ounce Tall Natural LDPE plastic into molds for making vials, by blanking out the generally cylindrical threaded outlet portion of said bottle molds.
8/ For item 6 above, consider converting the amber colored molds, presently used by pharmacies, having approx. 1 inch outside diameters for the 13 and 16 dram sizes, by eliminating said vial's cap outlet connections, and using Chevron's PE 5104 LDPE molding resin or equal. Note the 16 dram vial has the same capacity as the one ounce mentioned in item 7 above.
9/ Other options for making the closure outlet lips air-tight are, blow-mold the container with preformed curved outlet lips, having minimum allowable clearance between said outlet lips, for a/ post-forming said outlet lips by heating and compression clamping by others, or b/ do the final nesting of the curved outlet within the blow mold housing as previously specified, or shrink-fit the metal mold housing during its cooling down period. Special alloys such as used by Uniloy for the aerospace industries may be needed.
10/ When output production demands it, consider using ultrasonic energy for softening and shaping the LDPE plastic. Operate the ultrasonic unit at the plastic's softening point which is approx. 200 degrees F. to prevent melting thereof.
11/ Regarding Tamper Evident Closure: Presently, standard caps for cylindrical round bottles used by pharmacies are not tamper proof, but should be, for protection against tampering, particularly when left overnight for later pick-up by tardy customers; furthermore, different caps, ratio being 2 to 1 in favor of “Child-Resistant” over “Not Child Resistant” are required, both unfriendly to elderly and arthritics; whereas, simply overlapping this unique pill-box, as shown per
1 shows cross section of the portion released from the 8½″×11″ adhesive protective liner for making said tamper evident seal closure.
Note the self-adhesive prescription paper label 27, initially, is manually pressed against the concave portion of the elongated curved opposing wall 15 thus offering resistance to flex, making it more difficult, if not impossible for a child to squeeze open pillbox 10. Said arrangement gives an in-house tamper evident protection that allows the pharmacist to perform other duties prior to contacting the customer for direct sale. Rather than tearing off the label from its printed fold line portion 28 atop the elongated outlet lips 16 of pillbox 10, the customer, has the option of merely pulling it back for dispensing or reapplication for further protection against tampering, possibly by children.
1 is the cross section of the above dimensioned plan view version of
STEP 1 bend self adhesive label 27 at its tear-away seam 28, for alignment and centering of said label with outlet lips 16 and then bonding the convex top portion of said elongated lips and the remaining portion of 27 to the front portion of the lid-less pillbox 10
STEP 2 continue wrapping portion 27′ at the separation fold line 28 and bend said portion 27′ for wrapping the concave portion of the curved elongated outlet as described in
STEP 3 is a cross-sectional view of lid-less pillbox 10 bonded with self-adhesive label 27 full length of front of the pillbox, whereas the back portion 27′ is shown in phantom for pulling out by the customer's thumb 3 and finger 4 for tear-off and exposure of pillbox outlet for dispensing pills.
While the principles of the invention have been made clear in illustrative embodiments employing specified materials, there will be immediately obvious to those skilled in the art many modifications of structure, arrangement, proportions, the elements, materials, and components used in the practice of the invention, and otherwise, which are particularly adapted to specific environments and operative requirements without departing from those principles. The appended claims are intended to cover and embrace any and all such modifications, within the limits of only the true spirit and scope of the invention.
This application relates to the “Self-Closing Valve With Tamper Evident Lip Seal Tab” Ser. No. 07/08/88, U.S. Pat. No. 4,917,267, granted Apr. 17, 1990 and a continuation-in-part of U.S. patent application Ser. No. 10/033,640.
Number | Date | Country | |
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60553327 | Mar 2004 | US |
Number | Date | Country | |
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Parent | 10033640 | Jan 2002 | US |
Child | 10885562 | Jul 2004 | US |