CA2305130A1 - An attachable dosage timing indicator for prescription drug containers - Google Patents

Abstract

The invention is a flexible, manually operated dosage timing indicator which may be attached to a prescription drug vial, box or bottle to remind the user when the next dosage should be taken, or if such dosage has already been taken but forgotten, indicating these facts to the user.

In a preferred embodiment one size of the invention using a flexible, strap-like main component accommodates prescription containers of all formats, types, sizes and materials, including plastic and glass vials, bottles and cardboard or plastic boxes. An alternate embodiment using a preformed, and more rigid C-shaped version of the strap-like component plus all of the same components, markings and methods of attachment to a container as the preferred embodiment, may be used exclusively with cylindrically-shaped prescription vials or bottles.
Other than this essential difference, all references to the invention or device hereinafter in this patent application apply to both embodiments.

The application, components, indicia and operation of the device allow it to be used by non-impaired, literate persons as well as by individuals who are impaired, illiterate, who do not read or understand English and/or who suffer from poor eyesight or are totally blind.

Description

SPECIFICATIONS
This invention relates to a flexible, manually-operated device which may be permanently or removeably attached to any format or size of plastic or glass drug prescription vial or bottle, or plastic or cardboard box (hereinafter collectively referred to as prescription containers), for the purposes of reminding the user when his/her next dosage should be taken, or, in the event that such dosage has already been taken but forgotten, indicating these facts to the user.
By so doing, this device effectively reduces or eliminates the health risks of missing a medicinal dose or of overdosing.
Research has revealed prior art patented by the US Patent and Trademark Crffce. This prior art is listed with this application under the heading References Cited. Prior art falls roughly into two types: (a) those that completely re-design or re-configure the appearance, utility and child-proof safety benefits of the conventional plastic prescription drug vial and/or its cap or closure system, and (b) complex, mufti-function mechanical or electronic devices that work independently from, or in concert with the conventional vial to provide the user with a range of claimed safety and other related operational advantages.
No prior art claims define a preferred embodiment of an attachable dosage timing indicator that may be used effectively and identically on all current types, sizes and materials of prescription drug containers, including plastic and glass vials, bottles and cardboard or plastic boxes.
Also, as of the date of this application, research has shown that no prior art devices have achieved any introduction to, presence or even limited commercial success in the marketplace.
In addition to the stated limitations of prior art solely to conventional, cylindrical plastic prescription vials, other reasons for the apparent commercial failure of prior art would appear to be that (a) they are relatively complex to manufacture;
(b) producing them uses plastic resins and other materials in volumes that do not justify the throwaway nature of the end-product, and (c) for the most part, they replace part or all of a pharmaceutical drug containment system (including in some cases child-proof closures) that are trusted by, and familiar to dispensing pharmacies and their customers.
For most manufacturers, the advantages claimed by prior art would not warrant the premium costs of developing, testing and producing these devices, nor the low return on investment (minimum margins would be mandatory to induce sales), or the costs of re-educating consumers on the correct operation and maintenance of new, prior art devices.
For pharmacists, the claimed benefits would likely not outweigh the costs and inconveniences of obsoleting an existing, familiar and time-proven prescription vial product and its supporting infrastructure.

ANATTACHABLE DOSAGE TIMING INDICATOR FOR PRESCRIPTION DR UG CONTAINERS: PAGE 2 The inventive idea which the new article or system embodies, and the ways in which resort to it overcomes the difficulties and inconveniences of previous practices or proposals.
In a preferred embodiment the invention comprises two components: a flexible strap-like member around a section of which is clasped a frictionally moveable, sliding indicator member. A second embodiment employs a more rigid, preformed C-shaped member in place of the flexible strap-like member, and includes the same sliding indicator member.
In its preferred embodiment one size of the invention accommodates prescription containers of all formats, sizes, types and materials.
In use, the strap-like member with the sliding indicator member in place is axed on the outer surface of the prescription container in a location that allows easy visibility but that does not obscure vital drug information and/or administration instructions on the label.
The strap-like member is held in place on the prescription container by two or more adhesive-treated areas on the inside surfaces of each of its ends, or at specific locations, or in a narrow central strip along part, parts, or the entire inside length of the strap-like member. Methods and materials other than pre-applied contact adhesives to permanently or removeably attach the strap-like member to the prescription container are within the scope of the invention.
The outer-facing surface of the strap-like member is imprinted at regular intervals with indicia to identify and manage drug administration for either:
(a) One dosage a day (at a prescribed hour or event, such as prior to, during or after a meal, or on waking or retiring, or other event), for each day or a prescribed number of days during a 7-day week, or (b) Several dosages a day at hourly periods within a total 12 or 24-hour period, or (c) Several dosages a day prior to, with, or after specific events, such as, but not limited to each of two, three or more designated mealtimes, exercising or resting, and employing the appropriate identifying indicia, or (d) One or more dosages per week, or on specific days, intervals or events during each week or other given period.
If the dosage regimen is not covered by the selection of dosage indicia described, an alternative embodiment of the strap-like and/or C-shaped member is a blank (i.e.: indicia-free) member marked solely with a number of equally -spaced dividing marks. This embodiment allows pharmacy employees to custom-create the indicia necessary on, beside or between these marks as may be required, using permanent marking pens or other appropriate implements.
All other dosage time periods or dosage events that may now or in the future be specified by medical doctors are included in the scope of the data able to be communicated by the indicia of the invention, and where applicable, any indicia used may also be simultaneously reproduced tactually in Braille for the benefit of sight-impaired users.
A future development of the invention envisages the use of any available horizontal sections of the traditional prescription label as carriers of evenly-spaced indicia. Such indicia might be pre-printed or custom-created (by pharmacy star on selected areas of the label specifically for a dosage regimen specified on the prescription label, or may reflect the most commonly specified choices of prescription regimens.
With developments such as these, the strap-like or C-shaped member of the invention would be manufactured out of a transparent material to allow the pre-printed or custom-created indicia on the label to show through. Either type of member may be affixed to the container by pre-applied adhesive segments on the inside-facing extremities of the strap-like or C-shaped member. If preferred, however, attachment to the container may be by means of a transparent adhesive pre-applied in segments, or in a continuous, narrow strip, along the centre-line of the inside-facing surfaces of the strap-like or C-shaped members. If the latter location and type of adhesive are employed, the upper and lower clasping sections on the rear of the sliding indicator member must necessarily be of a size and design to allow free, unrestricted horizontal frictional movement of the sliding indicator member without hindrance from the adhesive (see drawings; Page 213, Figure 9, back view).

ANATTACHABLE DOSAGE TIMING INDICATOR FOR PRESCRIPTION DR UG CONTAINERS: PAGE 3 Prescription drugs are prescribed by qualified doctors for dispensation by pharmacists and self administration by responsible adult patients, or administration by caregivers to child patients or to those incapable of normal adult self determination, with all such administration taking place within specific regimens. Full, pertinent details of the prescribing doctor's written prescription, including the required administrative regimen, are normally transferred by an employee of the dispensing pharmacy in plain, instructional terms onto a label which is then affixed to the prescription container.
It is not uncommon, however, for the user to forget to take his/her medication at the prescribed time or in the prescribed manner defined by such instructions. In the same way, the user often forgets whether or not he/she has already taken a specific dosage, and will as a consequence either repeat the dosage (overdose) or miss that dosage altogether.
Forgetfulness such as this is more prevalent in older persons - the very people who are more likely to be managing their health with the aid of prescription drugs.
Drug prescription systems which offer pills encased visually or tactually by the manufacturer in clear plastic and/or foil pockets in one or more sleeves per box offer limited dosage security to the forgetful user. In order to check whether or not he/she has taken a specific dosage, the user is required to compare the number of pills taken to date (or yet to be taken) against the specified dosage regimen, and then also factor in the number of days since the regimen began.
Also, unlike pills supplied in prescription vials equipped with child-proof closures, pills supplied in pre-packed plastic/foil formats offer no security against accidental or willful misadministration by patients, children or other unauthorized persons.
Depending on the type and purpose of medication(s), repeatedly missing a prescribed dose or overdosing could have deleterious or even fatal effects on the patient/user with such effects magnified by the health and age of the subject, the degree of misadministration and the significance of the drug to the subject's health and wellness.
The commercial disadvantages of all other prior art may be overcome by the key, operational and business criteria of the invention. These criteria, and the categories of interested parties most influenced or affected by them are as follows.
Manufacturers: The device is simple, rugged, straightforward and low-tech. In its preferred embodiment one size of the device accommodates all types, sizes and materials of prescription containers, writh customized indicia alone being imprinted, embossed or debossed on the strap-like or C-shaped member during or after manufacture. This makes the device cheap to produce as well as lightweight to allow low-cost bulk packaging and delivery to distributors or to direct, drug-store clients. The simplicity of this rugged device also reduces the chance of breakages or other types of operational failures, thus also reducing warranty claims and/or product returns and replacements.
Pharmacies: The device compliments their existing inventories of, and order/supply/storage and application systems for all types, sizes and materials of conventional prescription containers, and additionally enhances key safety and effectiveness features which may be incorporated into these containers. In addition, blank (indicia-free) versions, plus word-free pictographic and/or Braille-marked dosage indicators allow their effective, customized use with practically every type of customer and drug prescription regimen. In the same way in which self adhesive prescription labels are now individually custom-prepared and placed by pharmacy staff on prescription containers, it is anticipated that initially, pharmacy staff would also select the style of the device (i.e. strap-like or C-shaped) and indium that correspond to the needs of each customer and to his/her dosage regimen, and apply such device onto it's the filled prescription container, following simple pictorial instructions. Placing the device on the prescription container could also eventually be the responsibility of the customer/end-user.
Users: The easy application, obvious operation and significant benefits of the device are immediately self-evident. This eliminates the need to, and inconvenience of poring over detailed written instructions. The use of simple pictographic indicia on the device also enhances its appeal for those who have difficulty reading English or who are illiterate. For sight-impaired users, the inclusion of Braille indicia in the same locations as indicia for sighted users helps to diminish or remove the users' insecurity about self managing their dosage administration.
The valuable safety advantages of the device would likely also significantly outstrip its low, anticipated cost -- if such cost was charged separately or at all by dispensing pharmacies.

ANATTACHABLE UOSAGE TIMING INDICATOR FOR PRESCRIPTION DRUG CONTAINERS: PAGE 4 In its preferred embodiments the device provides users with a simple, straightforward system for checking both the time of their next dose within a specific medication regimen, as well as whether such dose has already been taken. No other instructional or informational claims relating to prescribed drugs are made for the invention as it is intended for use exclusively as an attachment to prescription drug containers to which labels carrying this instructional and informational data have previously been aff xed.
In its preferred embodiment the product would be manufactured out of plastic resins by plastic injection moulding or by plastic extrusion. If required and deemed feasible, however, other suitable materials and manufacturing techniques may be used.
In drawings that illustrate the embodiments of the invention, Figure 1 is a general view of the preferred embodiment equipped with a flexible, strap-like member. Drawings of the strap-like member in Figures 1, 3, 4 and 5 are dramatically curved at their extremities solely to illustrate the flexibility of the unit as well as to reveal the locations of the two adhesive areas 5 (in Figures 1, 2 and 5), and the alternate single, continuous strip of adhesive 6 (in Figure 3). Figure 2 is a general view of the alternate embodiment equipped with a more rigid C-shaped member.
With the exception of the application of the C-shaped member exclusively for cylindrically-shaped prescription drug containers, all references in the drawings to the methods of, and materials for attachment; to the types, applications and non-applications of indicia andlor to the design formats of sliding indicator members apply to both embodiments of the invenrion.
Fygures 1 and 2 are front views of the flexible and C-shaped strap-like members showing typical 12-hour indicium 3 revealed through window 4 on the faces of sliding indicator member 1, plus adhesive attachment point 5 on the inside-facing extremities of the strap-like and C-shaped member 2.
Figure 3 is a back view of the preferred embodiment showing an alternative adhesive format, i.e: a narrow strip 6 along the centre of the inside-facing surface of the strap-like member 2. Note that the design of the rear clasping portions of the sliding indicator member 1 allows this member to slide freely along the length of the strap-like member without obstruction from the adhesive strip 6. The basic elements of the design of this style of sliding indicator member are shown in more detail in Figure 9 (back view).
Figure 4 is a bird's eye view of the preferred embodiment of the device as depicted in Figure 3, showing the relative thickness of the two major components of the sliding indicator member. This view also shows how affixing the strap-like member to the prescription container applies friction directly between the body of the container and the protruding rear parts of the sliding indicator member, which friction effectively restricts inadvertent movement of the sliding indicator member.
Figure 5 is a front view of the unit with blank, equal-sized indicia spaces 7 ready for customizing by pharmacy staff for a specific dosage regimen. Also shown are the upper and lower horizontal spaces 8 and 9 for use if required by a sponsor (or sponsors) of the dosage indicator, and the (optional) words NEXT DOSE on either side of the window on the face of the sliding indicator member. These words, or their equivalent in any applicable language, pictograph and/or Braille are proposed as may be required or deemed necessary by the producer of the device.
Figure 6 is a partial view of the transparent version of the strap-like member (6A) in place over a partial depiction of a prescription label (6B) fixed to the curved surface of a vial or bottle. This label has been pre-printed with typical indicia for three, equally-spaced daily dosage times (or mealtimes) of AM, Non and PM.
Figure 7 is a view of an alternate design for the front and back of the sliding indicator member. The back view shows diagonally-cut upper and lower extensions from the face of the member, which extensions hold the sliding indicator member in place on the strap-like member and provide the friction necessary (as described under Figure 4) to movably retain the sliding indicator member in a iare-selected locatnon. Please note that, to avoid unnecessary visual confiision, details of the rear components in Figures 7 and 8 are not shown through the windows 4 in their respective front views.

ANATTACHABLE DOSAGE TIMING INDICATOR FOR PRESCRIPTION DRUG CONTAINERS: PAGE 5 Figures 8 and 9 are views of two other, alternate designs for the front and back of sliding indicator members in which the back elements are also extensions of the faces of the sliding indicator members. In Figure 8 the design of the back incorporates three tongue-like elements: two attached to the lower edge of the sliding indicator member, and the third tongue-like element attached centrally to the upper edge of the member.
Figure 9 additionally shows a hexagonal design with a square window 4, and with upper and lower rear clasping extensions to hold the indicator member slidingly on a strap-like or C-shaped component to which a narrow, centrally-applied strip of adhesive (as per Figure 3) has been applied.
The wide choices of engineering designs which may be employed in the production of effective, low-cost and logistically-sound sliding indicator members preclude the inclusion of specific individual preferences in this document. Any designs which deliver these three key characteristics (i.e. effective, low-cost and logistically sound) are therefore claimed as preferred embodiments of this component of the invention.
Figures 10, 11 and 12 show a selection, but not all possible installation locations, of dosage indicators on (Figure 10) a glass or plastic bottle of liquid medication, on (Figure 11) a conventional plastic prescription vial, and on (Figure 12) a cardboard or plastic box of pill or powder medication. The preferred and alternate embodiments of the device may be used successfully on cylindrical bottles (Figure 10) or vials (Figure 11) that are circular in section; the preferred, flexible embodiment alone, however, is useable on bottles, vials or other types of containers of any shape or geometric cross-section. All markings and indicia are omitted here from the device for clarity.
To equip a prescription drug vial with the invention: The installer first ensures that he/she has selected the device with indicia which matches the requirements of the prescribed dosage regimen and removes any protective packing that may contain the invention and its pictorial installation instructions. If not already factory-installed, the sliding indicator member 1 is clasped in place by the installer around the strap-like member 2 to allow the indicia 3 revealed through the window 4 as well as the sponsor's name, logo or other ID (8 and 9 on Figure 5) on the strap-like member to be viewed the right way up.
In place of, or in addition to the window 4, the sliding indicator member 1 may carry a vertical mark or arrowhead or any other type of symbol or device that effectively indicates a specific position or indicium selected by the user on the strap-like member. Also, the window 4 may be any shape deemed suitable or appropriate for this task.
In a preferred embodiment, the face of the sliding indicator member I which contains the window 4 is finished in a colour or other surface treatment which contrasts with the colours) or surface treatments) of the face of the strap-like member 2 and its indicia 3. Strong visual contrasts such as described aid the ready visibility of the indicium selected and revealed through window 4.
The assembled device Figure 6, (6A) is held snugly against the prescription container in a location that does not obscure any vital information on the label (6B). The installer then removes the protective strips covering the two (or more) adhesive areas (5 or 6 on Figures I, 2 and 3 respectively) on the inside-facing surfaces of the strap-like (Figures 1 and 3) and C-shaped member (Figure 2) and presses these adhesive areas in place on the prescription container.
To use the invention: After taking his/her first dosage from a prescription container equipped with the invention, the end-user moves the sliding indicator member 1 to reveal through window 4 the time, day or other event when his/her next dosage must be taken. This procedure is repeated after each subsequent dosage.
Later reference by the end-user to the specific indicium selected, plus a quick check of the current time will also alert him/her that helshe has already taken this earlier dosage. This helps to reduce or prevent the risk of his/her overdosing. If the sliding indicator shows a dosage time, day or event that has passed, however, the user is immediately made aware that he/she has missed a dosage.

ANATTACHABLE DOSAGE TIMING INDICATOR FOR PRESCRIPTION DRUG CONTAINERS: PAGE 6 The frictional contact points between the sliding indicator member, the strap-like member and the surface of the prescription container directly behind the strap-like member effectively allow the sliding indicator member to resist unintentional movement if it is accidentally handled or if a vial fitted with the device is placed against another object in a handbag or pocket.
In the same manner, the correct placement of the dosage indicator on the prescription container means that the processes of removing or replacing a conventional screw-top cap or child-proof closure on a prescription container so equipped will not normally bring the user's hands or fingers into moveable contact with the sliding indicator member.

Claims

AN ATTACHABLE DOSAGE TIMING INDICATOR FOR PRESCRIPTION DRUG CONTAINERS: PAGE

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

Claim #1: An attachable dosage indicator for prescription containers that is manufacturable at a cost consistent with the throwaway nature of the prescription vials, pill boxes and bottles on which it functions.

Claim #2: An attachable dosage indicator that, in its preferred embodiment as defined in Claim #1 is manufacturable if required in a single size to accommodate all formats, sizes, types, shapes and materials used for prescription containers currently and in the future.

Claim #3: An attachable dosage indicator as defined in Claims #1 and #2 that comprises a flexible, strap-like member and a fractionally-mounted sliding indicator member that are attached permanently or removeably as a single unit to the outer surfaces of prescription containers or all formats, sizes, types and materials.

Claim #4: An attachable dosage indicator as defined in Claim #1 that comprises a more rigid, pre-formed C-shaped member and a fractionally-mounted sliding indicator member which together are attached permanently or removeably as a single unit to the outer surfaces of cylindrically-shaped plastic or glass prescription containers.

Claim #5: An attachable dosage indicator as defined in Claims #1, #2, #3 and #4 with a flexible, strap-like or more rigid C-shaped member imprinted or embossed or debossed at regular intervals on its outer-facing length with indicia that represent the administrative timing and/or defining events of the dosage regimen of specific drug prescriptions.

Claim #6: An attachable dosage indicator as defined in Claims #1, #2, #3, #4 and #5 with a strap-like or C-shaped member imprinted or embossed or debossed at regular intervals on its outer-facing length with vertical, evenly-spaced dividing marks to guide the handwritten application of customized dosage indicia.

Claim #7: An attachable dosage indicator as defined in Claims #1, #2, #4, #4.
#5 and #6 with a strap-like or C-shaped member manufactured out of clear plastic to allow pre-printed or custom-written indicia on a label or other marked surface placed on the container to show through.

Claim #8: An attachable dosage indicator as defined in Claims #1, #2, #3, #4, #5, #6 and #7 that provides space on the outward face of the strap-like or C-shaped member for the name(s) and/or logo(s) and/or slogan(s) and/or other identifying features of a business sponsor(s) or other organization(s).

Claim #9: An attachable dosage indicator as defined in Claims #1, #2, #3, #4, #5, #6, 7 and #8 that includes a fractionally-mounted sliding indicator member which incorporates a window or other index marking or visual reference point that allows the user to accurately and temporarily select the next dosage time or event in his/her dosage regimen.

Claim #10: An attachable dosage indicator as defined in Claims #1, #2, #3, #4, #5, #6, #7, #8 and #9 that is attached to prescription containers by an adhesive or similar material or method which works effectively and simultaneously on plastics, glass and cardboard prescription container materials as well as on any surface treatments which may be given to these materials.

Claim #11: An attachable dosage indicator as defined in Claims #1, #2, #3, #4, #5, #6, #7, #8, #9 and #10 that is held in place on the prescription container by a pressure contact adhesive or similar material or method that is pre-applied on one or more locations on the inside surface of the strap-like or C-shaped member.

AN ATTACHABLE DOSAGE TIMING INDICATOR FOR PRESCRIPTION DRUG CONTAINERS: PAGE

Claim #12: An attachable dosage indicator as defined in Claims #1, #2, #3, #4, #5, #6, #7, #8, #9, #10 and #11 that employs alphanumeric and/or pictorial and/or symbolic indicia, or any combination of such indicia or non-English languages, numbers and/or alphabets to allow easy, accurate interpretation and use of such indicia by persons who do not easily read or understand English, or who are functionally illiterate.

Claim #13: An attachable dosage indicator as defined in Claims #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11 and #12 on which all indicia and other written words used may also be simultaneously and tactually represented in braille for the benefit of sight-impaired users.

Claim #14: An attachable dosage indicator as defined in Claims #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12 and # 13 whose correct operation does not interfere with, confuse or confound any childproofing or other safety features that may be integral parts of specific prescription container systems.