WO2014013392A1

WO2014013392A1 - Temporal monitoring of drugs administration

Info

Publication number: WO2014013392A1
Application number: PCT/IB2013/055694
Authority: WO
Inventors: Nimrod Sandlerman; Arbel SANDLERMAN
Original assignee: Nimrod Sandlerman; Sandlerman Arbel
Priority date: 2012-07-18
Filing date: 2013-07-11
Publication date: 2014-01-23

Abstract

Means for identifying time as of the opening of a closure, such as a blister pack for medications, including means for activating the time identification process upon the opening of the closure, and means for displaying a code associated with time elapsing from the activation; wherein said activation initiates, for example, exposure to at least one of air, oxygen, humidity and light, evaporation, sublimation, and electric contact; and said code comprising a change of area of at least one of color and opacity.

Description

TITLE OF THE INVENTION:

Temporal Monitoring of Drugs Administration

FIELD AND OF THE INVENTION

The present invention generally relates to systems and methods for monitoring the time elapsing since the opening of a closure, and, more particularly, but not exclusively to methods and systems for monitoring the time elapsing since the administration of drugs.

BACKGROUND OF THE INVENTION

There is a recognized need for monitoring the administration of drugs. People are forgetful even for very recent actions, and may forget if a drug was actually taken or not. Inappropriate administration of drugs is a major cause for emergency treatments and hospitalizations of people that have an otherwise self-managed health situation. While there are many means to remind a patient or his care taker to take a medicine it is difficult to make sure if and when exactly the medication was actually taken. It would therefore be highly advantageous to have a method and a system for monitoring drugs administration that overcome the abovementioned deficiencies.

SUMMARY OF THE INVENTION

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The materials, methods, and examples provided herein are illustrative only and not intended to be limiting. Except to the extend necessary or inherent in the processes themselves, no particular order to steps or stages of methods and processes described in this disclosure, including the figures, is intended or implied. In many cases the order of process steps may vary without changing the purpose or effect of the methods described.

Implementation of the method and system of the present invention involves performing or completing certain selected tasks or steps manually, automatically, or any combination thereof. Moreover, according to actual instrumentation and equipment of preferred embodiments of the method and system of the present invention, several selected steps could be implemented by hardware or by software on any operating system of any firmware or any combination thereof. For example, as hardware, selected steps of the invention could be implemented as a chip or a circuit. As software, selected steps of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps of the method and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.

According to one aspect of the present invention there is provided a time-monitoring marker including means for identifying time as of the opening of a closure the means including means for activating the time identification process upon the opening of the closure; and means for displaying a code associated with time elapsing from the activation.

According to another aspect of the present invention there is provided a time- monitoring marker for identifying time as of the opening of a closure where the means is operative to identify that the opening occurred within a predetermined period prior to checking the means.

According to still another aspect of the present invention there is provided a time- monitoring marker for identifying time as of the opening of a closure where the code includes at least one of change of color and change of opacity.

According to yet another aspect of the present invention there is provided a time- monitoring marker for identifying time as of the opening of a closure where the code includes change of area of the at least one of color and opacity.

Further according to another aspect of the present invention there is provided a time- monitoring marker for identifying time as of the opening of a closure where the change of color includes at least one of increasing and fading the color.

Still further according to another aspect of the present invention there is provided a time-monitoring marker for identifying time as of the opening of a closure where the means includes a part of a blister pack for medications; where the opening includes the opening of a single blister; where the activation is associated with the opening of the single blister; and where the code is associated with time passing since the opening of the single blister.

Yet further according to another aspect of the present invention there is provided a time-monitoring marker for identifying time as of the opening of a closure where the activation initiates exposure to at least one of air, oxygen, humidity and light.

Even further according to another aspect of the present invention there is provided a time-monitoring marker for identifying time as of the opening of a closure where the activation initiates at least one of evaporation and sublimation.

Additionally, according to another aspect of the present invention there is provided a tag for identifying time as of opening a blister of a blister package, the tag including: a detachment part for activating a time identification process upon the opening of the blister; and a time measuring part for displaying a code associated with time elapsing from the activation.

Also according to another aspect of the present invention there is provided a tag according to claim 1 where the tag is operative to identify that the opening occurred within a predetermined period prior to checking the tag.

According to yet another aspect of the present invention there is provided a tag according to claim 1 where the code includes at least one of change of color and change of opacity.

According to still another aspect of the present invention there is provided a tag according to claim 3 where the code includes change of area of the at least one of color and opacity.

Further, according to another aspect of the present invention there is provided a tag according to claim 3 where the change of color includes at least one of increasing and fading the color.

Still further according to another aspect of the present invention there is provided a tag according to claim 1 where the means includes a part of a blister pack for medications; where the opening includes the opening of a single blister; where the activation is associated with the opening of the single blister; and where the code is associated with time passing since the opening of the single blister.

Yet further according to another aspect of the present invention there is provided a tag according to claim 1 where the activation initiates exposure to at least one of air, oxygen, humidity and light.

Even further according to another aspect of the present invention there is provided a tag according to claim 1 where the activation initiates at least one of evaporation and sublimation.

Additionally, according to another aspect of the present invention there is provided a tag according to claim 1 where the activation initiates an electric contact between two or more electrodes.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the embodiments of the present invention only, and are presented in order to provide what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

In the drawings:

Fig. 1A is a simplified illustration of a front view of a time-monitored blister-pack;

Fig. IB is a simplified illustration of a back view of the time-monitored blister-pack showing time-monitoring markers;

Fig. 1C is a simplified illustration of a side view of the time-monitored blister-pack;

Fig. 2 is a simplified illustration of the time-monitored blister-pack with several monitoring markers open and other monitoring markers closed;

Fig. 3 is a simplified illustration of the inner side of a monitoring marker;

Fig. 4 is a simplified illustration of the inner side of a tubular monitoring marker;

Fig. 5 is a simplified illustration of the inner side of a conical tubular monitoring marker;

Fig. 6 is a simplified illustration of the inner side of a multi-stricture tubular monitoring marker;

Fig. 7 is a simplified illustration of the inner side of a tapered tubular monitoring marker; Fig. 8 is a simplified illustration of the inner side of a serpentine tubular monitoring marker;

Fig. 9 is a simplified illustration of a monitoring sheet having slanted monitoring markers;

Fig. 10 is a simplified illustration of a monitoring sheet having dual slanted monitoring markers;

Fig. 11 is a simplified illustration of a monitoring sheet with linear push-peal monitoring markers;

Fig. 12 is a simplified illustration of a plurality of monitoring sheets with circular push-pealed monitoring marker;

Fig. 13A is a simplified illustration of a three-color time-monitoring marker before being activated by a user;

Fig. 13B is a simplified illustration of the three-color time-monitoring marker after activation by the user;

Fig. 14 is a simplified illustration of a multi-color time-monitoring marker having 5 colors;

Fig. 15 is a simplified illustration of a time-monitoring tag using blending of two types of materials;

Figs. 16A, 16B, 16C, and 16D are simplified illustrations of the blending time- monitoring tag in deferent stages of activating process;

Figs. 17B and 17B are simplified illustrations of a time-monitoring tag using flow delay mechanism before and after a user have pealed the tag;

Figs. 18A, 18B, and Fig. 18C are simplified illustrations of a three-stage detachment mechanism;

Figs. 19A and 19B are simplified illustrations of a time-monitoring tag using trickling fluid; Fig. 20 is a simplified illustration of a time monitoring tag including a series of flow delay elements;

Figs. 21A, 21B, 21C, 21D, and 21E are simplified illustrations of various views of a time-monitoring tag including a pair of detachable barriers;

Figs. 22B and 22B are simplified illustrations of a battery-operated time-monitoring tag; and

Fig. 23A, Fig. 23B, Fig. 23C, and Fig. 23D are simplified illustrations of four views of an activation switch for the battery-operated time-monitoring tag.

DETAILED DESCRIPTION OF THE INVENTION

The principles and operation of a method and a system for temporal monitoring of drugs administration according to the present invention may be better understood with reference to the drawings and accompanying description.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

In this document, an element of a drawing that is not described within the scope of the drawing and is labeled with a numeral that has been described in a previous drawing has the same use and description as in the previous drawings. Similarly, an element that is identified in the text by a numeral that does not appear in the drawing described by the text, has the same use and description as in the previous drawings where it is described.

The purpose of the system and method for temporal monitoring of drugs administration described herein is to provide means to assess the time that elapsed since a drug was take. More particularly, the present invention provides means to monitor the time that passed since a blister containing a drug was opened. The present invention is therefore appropriate for any type of closed cavity enabling a user to assess the time elapsing since the cavity is opened. Hence the term "blister" herein may mean any type of closed cavity or closed compartment. Preferably, however, in a non-limiting manner, the term "blister" refers to a cavity or compartment having a distinct opening part or area.

Reference is now made to Figs. 1A and IB, which are simplified illustrations of a time-monitored blister-pack 10 equipped with time-monitoring markers 11, according to a preferred embodiment of the present invention

Fig. 1A shows a first side of the time-monitored blister-pack 10 (or simply blister- pack 10). As shown in Fig. 1A, the blister-pack 10 preferably contains a drug in the form of tablets 12, where each tablet is independently stored in its own blister 13. Fig. IB shows a second side of the blister-pack 10 where the time-monitoring markers 11 (or simply monitoring markers) are mounted.

Fig. 1C is not to-scale with Figs. 1A and/or Fig. IB. Fig. 1C shows a side view of a cut through the blister-pack 10, showing three parts of the blister-pack 10:

A first part 14, typically made of a rigid plastic material and containing the blisters 13.

A second part 15 (also named herein sealing part 15), typically made of a thin aluminum sheet, sealing and/or closes an opening of the blisters 13.

A third part 16 (also named herein monitoring sheet 16), typically made of a plastic material, and including one or more monitoring markers 11, which are preferably positioned over the openings of the blisters 13.

As shown in Figs. IB and 1C, each blister 13 is equipped with a monitoring marker 11. Preferably, a user may peel a monitoring marker 11 to expose the closure 17 over the opening of the blister 13 (in this example - the sheet part 13 closing and/or sealing the blister 13). The user may then pierce the closure 17 to expose the drug and or tablet 13 contained inside the blister 13

It is appreciated that the arrangement described in Figs. 1A , IB and 1C as the time- monitored blister-pack 10 is exemplary, and may be useful for drugs other than in the form of tablets, and/or for entities other than drugs.

It is also appreciated that the arrangement described in Figs. 1A , IB and 1C as the time-monitored blister-pack 10 is exemplary, and may include only two parts, for example by combining parts 15 and 16 into a single part, or by combining parts 14 and 15 into a single part. It is additionally contemplated that the arrangement described in Figs. 1A , IB and 1C as the time-monitored blister-pack 10 may be implement in a single part combining parts 14, 15 and 16.

It is further appreciated that part 16, that is a sheet including a single monitoring marker 11 or a plurality of monitoring markers 11 may be provided independently of a blister pack or a similar container. Thus a user may buy a blister pack (or a similar container) independently, and a monitoring sheet part 16 independently, and then attach the monitoring sheet part 16 over the blister pack to enable the monitoring of time elapsing after a blister is opened.

Reference is now made to Fig. 2, which is a simplified illustration of the time- monitored blister-pack 10 with some monitoring markers 11 open according to a preferred embodiment of the present invention.

Fig. 2 shows a monitoring sheet 16 over a blister-pack 10 with some of the monitoring markers 11, designated by numeral 18, being in closed mode, and other monitoring markers 11, designated by numeral 19, in open mode. The monitoring markers 11 designated by numeral 19 show the inner side of the monitoring markers 11.

As seen in Fig. 2, the monitoring markers 19 show different time periods since each monitoring marker 19 was peeled open. In the preferred example of Fig. 2 the monitoring marker 19 designated by numeral 20 was opened first and thus the coloring level retarded most. The monitoring marker 19 designated by numeral 21 was opened later and thus the coloring level retarded less. The monitoring marker 19 designated by numeral 22 was opened next and thus the coloring level retarded even less. While the monitoring marker 19 designated by numeral 23 was opened last and thus the coloring level retarded least.

Reference is now made to Fig. 3, which is a simplified illustration of the inner side of a monitoring marker 11, according to a preferred embodiment of the present invention.

As seen in Fig. 3, the monitoring marker 11 preferably includes a body part 24 and a pulling tip 25. A user may pull on the pulling tip 25 to peel open the body part 24 from the sealing part 15. The body part 24 preferably includes:

A base part 26 that preferably remains attached to the sealing part 15 sealing the corresponding blister 13.

A time measuring part 27, which in the example shown in Fig. 3 is preferably a coloring part. The time measuring part 27 shows a measurement level (or coloring level) indicated by numeral 28.

A detachment part 29 that is preferably attached to the sealing part 15, and is detached from the sealing part 15 when the monitoring marker 11 is peeled open by pulling the pulling tip 25. When the detachment part 29 is detached the time measuring process is preferably initiated.

Time marks, or gratings, 30 to enable a user to asses the time elapsing since the detachment of the detachment part 29, or the peeling of the monitoring marker 11, by identifying the time mark 30 closest to the measurement level 28.

Reference is now made to Fig. 4, which is a simplified illustration of the inner side of a tubular monitoring marker 31, according to a preferred embodiment of the present invention.

The tubular monitoring marker 31 is a monitoring marker 11, such as described above with reference to previous figures, where the time measuring part 27 preferably includes tubes 32. The tubes 32 are preferably of a constant width, are of equal width, and are positioned in parallel. It is appreciated that other tube shapes and positioning of the tubes are possible.

Preferably, when the tubular monitoring marker 31 is attached to the sealing part 15, before it is peeled open, the tubes 32 are sealed at both ends. Preferably, when the detachment part 29 is detached from the sealing part 15 the sealing under the detachment part 29 is broken and the material inside the tubes 32 is exposed to the atmosphere.

Preferably, the material inside the tubes 32 is colorful, in the sense that it has a color, (in this respect the term color may include black, white, transparent and opaque) and that the color changes as described below. Preferably the change of color, or discoloration, results from exposing the material to the atmosphere. Such discoloration color may take at least any of the following:

A change from one color to another color

A change from lack of color to any type of color, or from any type of color to a lack of color.

A change from an opaque material to a transparent material, or from a transparent material to an opaque material.

A change from a colored material to transparent material, or from a transparent material to a colored material.

The process of discoloration (change or color) may result from oxidation of the material inside the tube 32 or any other reaction with any constitute of the atmosphere such as carbon dioxide (CO2). The rate of the discoloration may be adjusted by setting the size of the openings (orifices 33) of the tubes 32.

Alternatively, the process of discoloration may result from evaporation or sublimation of the material inside the tube. Again, the rate of the discoloration may be adjusted by setting the size of the orifices 33 of the tubes 32. The material inside the tube may have any suitable color. Alternatively, the material may be opaque and when evaporating or sublimating may expose various background colors preferably indicating time intervals.

Alternatively, the process of discoloration may result from the combination of two materials. For example, a first material undergoing evaporation or sublimation and thus enabling air to oxidize a second material.

Alternatively, the process of discoloration may result from the combination of three materials. For example, a first material separating between a second and a third materials. The first material gradually evaporation or sublimation and thus enabling two other materials to recombine.

Reference is now made to Fig. 5, which is a simplified illustration of the inner side of a conical tubular monitoring marker 34, according to a preferred embodiment of the present invention.

As seen in Fig. 5, the conical tubular monitoring marker 34 is similar to the tubular monitoring marker 31 except that tubes 35 have a cut area (the area of the cut perpendicular to the tune's length) that widens along the length of the tube. Therefore, the rate of discoloration changes as the discoloration progresses. Preferably the cut area widens with the distance from the orifice 33 and therefore the rate of discoloration decreases with time. Therefore, the time marks 30, which indicate equal periods, get closer with the distance from the orifice 33. This enables the tubular monitoring marker 31 to indicate longer elapsed time over the same length of time measuring part 27.

Reference is now made to Fig. 6, which is a simplified illustration of the inner side of a multi-stricture tubular monitoring marker 36, according to a preferred embodiment of the present invention. As seen in Fig. 6, the multi-stricture tubular monitoring marker 36 is similar to the tubular monitoring marker 31 except that tubes 37 have several strictures 38 along the length of the tube. Each stricture 38 further slows the rate of discoloration as the discoloration progresses along the tube. Preferably the cut area of the stricture reduces with the distance from the orifice 33. Therefore, the time marks 30, which indicate equal periods, get closer with the distance from the orifice 33. This enables the tubular monitoring marker 31 to indicate longer elapsed time over the same length of time measuring part 27.

Reference is now made to Fig. 7, which is a simplified illustration of the inner side of a tapered tubular monitoring marker 39, according to a preferred embodiment of the present invention.

As seen in Fig. 7, the tapered tubular monitoring marker 39 is similar to the tubular monitoring marker 31 except that tubes 40 contain internal tubes 41, preferably tapered along their length, preferably, a material inside tubes evaporate or sublimates thus enabling air to reach the material in tubes 40 surrounding the tubes 41.

Reference is now made to Fig. 8, which is a simplified illustration of the inner side of a serpentine tubular monitoring marker 42, according to a preferred embodiment of the present invention.

As seen in Fig. 8, the serpentine tubular monitoring marker 42 is similar to the tubular monitoring marker 31 except that tube 43 has a serpentine shape and the shape of the serpentine waves increases with the distance from the orifice 33. Thus reducing the rate in which the measurement level 28 progresses and enabling the serpentine tubular monitoring marker 42 to measure a longer time period.

Reference is now made to Fig. 9, which is a simplified illustration of a monitoring sheet 44 having slanted monitoring markers 11, according to a preferred embodiment of the present invention.

As seen in Fig. 9, the monitoring sheet 44 is similar to the monitoring sheet 16 except that the monitoring markers 11 are slanted with respect to the blister-pack 10 to increase the density of the monitoring markers. Additionally, the monitoring sheet 44 is provided separately of the blister pack as an after-market product. Additionally, the monitoring sheet 44 is provided as an opaque sheet with space for advertising. Alternatively, the monitoring sheet 44 is transparent to enable the user to see the print on the sealing part 15.

Reference is now made to Fig. 10, which is a simplified illustration of a monitoring sheet 45 having dual slanted monitoring markers 11, according to a preferred embodiment of the present invention.

As seen in Fig. 10, the monitoring sheet 45 is similar to the monitoring sheet 44 except that the monitoring markers 11 are slanted in opposite directions to further increase the density of the monitoring markers.

Reference is now made to Fig. 11, which is a simplified illustration of a monitoring sheet 46 with linear push-peal monitoring markers 47, according to a preferred embodiment of the present invention.

As seen in Fig. 11, the monitoring sheet 46 is similar to the monitoring sheets described above except that the monitoring markers 47 are affixed to the monitoring sheet (rather than pulled away) and a push band 48 is used instead of a pulling tip 25. When the sealing part 15 is pieraced with a tip of a finger into the opening 49, the push band 48 is pushed too and is pealed from the detachment part 29, thus causing the initiation of the time measuring process by the time measuring part 27.

Monitoring markers 47 designated by numeral 50 show such monitoring markers having a push band 48 pushed and pealed from the respective detachment part 29, and a time measuring part 27 showing different measurements of time elapsed since the pealing of the push band 48 and the initiation of the time measurement, as indicated by the position of the measurement level 28.

Reference is now made to Fig. 12, which is a simplified illustration of a time- monitored blister-pack 10 with a plurality of monitoring sheets 51 each having a circular push-pealed monitoring marker 52, according to a preferred embodiment of the present invention.

As seen in Fig. 12, the monitoring sheet 51 is similar to the monitoring sheet 46 except that it has a single monitoring marker 52 having a circular time measuring part 53. When a user retrieves a tablet stored in the blister the user preferably pierces the sealing part 15. In doing so the user pushes push band 54 into the opening 55 and thus peals the push band 54 from the detachment part 29. This initiates the time measuring process by the time measuring part 53.

Monitoring markers designated by numeral 56 show such monitoring markers having the push band 54 pushed and pealed from the respective detachment part 29, and a time measuring part 53 showing different measurements of time elapsed since the pealing of the push band 54 and the initiation of the time measurement, as indicated by the position of the measurement level 28.

It is appreciated that the feature of single-marker sheet such as monitoring sheet 51 or multi-marker sheet such as monitoring sheet 46 is independent from the shape of the marker such as such as 11, 19, 31, 34, 36, 39, 42, 47, or 52 and that each type (shape) of marker can be implemented as a single-marker sheet or a multi-marker sheet.

Reference is now made to Figs. 13A and 13B, which are simplified illustrations of two states of a three-color time-monitoring marker 57 according to a preferred embodiment of the present invention.

Fig. 13A shows the three-color time-monitoring marker 57 intact, before it is activated by a user. Fig. 13B shows the three-color time-monitoring marker 57 some time after it is activated by the user.

As seen in Figs. 13A and 13B, the monitoring marker 57 preferably includes a circular time measuring part 58. When a user retrieves a tablet stored in the blister 59 the user preferably pierces the sealing part 60. In doing so the user also pushes push-band 61 into the opening 62 and thus peals the push band 61 from the detachment part 63. This initiates the time measuring process by the time measuring part 58.

As seen in Fig. 13B some time after the time measuring process has been initiated, a first marker coloring 64 has retreated, as indicated by the position of the measurement level 65. The retreating first marker coloring 64 exposes a second marker coloring 66 and then a third marker coloring 67.

It is appreciated that the second marker coloring 66 and the third marker coloring 67 can appear or be printed in an alternating manner, for example to mark hours or any other time unit. Preferably, the second marker coloring 66 marks the period in which administering the next drug is forbidden, for example, causing an overdose. That is, the period marked by the second marker coloring 66 as indicated by time level 68 indicates the minimal allowed time between drug administrations.

It is also appreciated that a scheme of four or more colors can also be employed in a similar manner.

It is appreciated that the three-color time-monitoring marker 57 can be shaped or configured as any of the previously described monitoring markers such as 11, 19, 31, 34, 36, 39, 42, 47, etc and can be manufactured as a single marker sheet like monitoring sheet 51 or as a multi-marker sheet like monitoring sheet 46.

Reference is now made to Fig. 14, which is a simplified illustration of a multi-color time-monitoring marker 69 according to a preferred embodiment of the present invention.

The multi-color time-monitoring marker 69 of Fig. 14 preferably use a 5-color scheme. Four of the colors of monitoring marker 69 designated by numerators 70, 71, 72, and 73, are arranged in alternating arcs 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, over time measuring part 58, where each arch preferably represents a time-unit such as one hour. The fifth color designated by numeral 87 covers the time measuring part 58.

As seen in Fig. 14, when a user pushes push band 88 and pierces the sealing part to each opening 89 and retrieve the drug from the blister, the detachment part 90 is torn thus activating the time measuring part 58. When the time measuring part 58 is activated the color 87 starts retreating with time, thus exposing the color-alternating arches 74 - 86 (further arches are still covered by color 87).

As seen in Fig. 14, colors 70 and 71 preferably indicate the forbidden (overdose) period and colors 72 and 73 preferably indicate the time past the forbidden period.

Reference is now made to Fig. 15, which is a simplified illustration of a time- monitoring tag 91 according to another preferred embodiment of the present invention, and to Figs. 16A, 16B, 16C, and 16D, which are simplified illustrations of the time-monitoring tag 91 in deferent stages of activating process. As seen in Fig. 15, the time-monitoring tag 91 is preferably similar to the time- monitoring markers 11 of Fig. 3, however, with a different activation mechanism 92. The time-monitoring tag 91 is preferably mounted on a blister pack or a monitoring sheet (such as monitoring sheet 16 of Fig. 3) in any manner such as those shown and described with reference to Figs. 1A to Fig. 14. The activation mechanism 92 is preferably initiated upon the pealing of the time-monitoring tag 91 from the sheet covering the opening of a blister as shown and described with reference to Fig. 2. Fig. 15 shows the time-monitoring tag 91 after it is pealed of from sheet the sheet covering the opening of a blister such as monitoring markers 19 of Fig. 2.

As shown in Fig. 15, the time-monitoring tag 91 preferably includes:

A sheet 93, for example, as a part of monitoring sheet such as monitoring sheet

16 as shown in Fig. 2. Sheet 93 preferably includes a body part 24 and a pulling tip 25. The body part 24 preferably includes:

Base part 26, preferably attaching body part 24 to the monitoring sheet or to any other sheet such as an aluminum sheet covering the openings of the blisters of a blister pack, such as closure sheet 17 shown in Fig. 2.

Time measuring part 27 showing a measurement level (or coloring level) such as indicated by numeral 28. Time measuring part 27p preferably includes the activation mechanism 92.

Detachment part 29 attaching the other side of body part 24 to the monitoring sheet or to any other sheet such as an aluminum sheet covering the openings of the blisters. Detachment part 29 is mainly used as a "safety latch" to disable spontaneous pealing of the time-monitoring tag. Detachment part 29 is therefore preferably optional.

The activation mechanism 92 preferably includes the blending and combination of two (or more) types of materials. The blending of the two materials activates a chemical reaction between the materials that affects the color and/or the transparency of the combined material. The two materials are stored in two containers 94 and 95 separated by a detachable barrier 96. The pealing of the time-monitoring tag 91 from the monitoring sheet 16 exposes an opening between the containers 94 and 95 and initiates the blending and combination process between the materials in the containers.

Preferably, an inhibitor material is distributed within the material of containers 94 and/or 95. The inhibitor material delays the reaction between the two materials of containers 94 and 95. The inhibitor material is distributed in increasing concentration along the length of the containers 94 and 95 as, for example, is indicated by arrow 97. Thus, the reaction between the two materials of containers 94 and 95 advances along the length of the containers and hence the color or transparency of the combined material changes with time along arrow 97. The concentration of the inhibitor material can be used to set the total time (span) measured by the time-monitoring tag 91, such as 24 hours.

One of the differences between time-monitoring tag 91 and time-monitoring markers 11 is that the activation mechanism 92 is sealed, and therefore it is never exposed to the ambient atmosphere and/or to the user. Thus the chemical process affecting the change of color or transparency is not affected by ventilation, humidity, various gases in the atmosphere, etc.

Figs. 16A-16D show four views of a cut through the time-monitoring tag 91, such as cut 98 shown in Fig. 15. Fig. 16A shows the time-monitoring tag 91 attached to the monitoring sheet 16 before the tag is pealed to expose the closure sheet 17 (e.g. aluminum sheet) covering the blister. Fig. 16B shows the activation mechanism 92 partly detached from Sheet 93, allowing contact between the two materials in containers 94 and 95. Fig. 16C shows the activation mechanism 92 fully detached from Sheet 93 enabling effective blending of the two materials of containers 94 and 95. Fig. 16D shows the activation mechanism 92 fully detached from the closure sheet 17 allowing the user to easily view the activation mechanism 92.

As seen in Figs. 16A-16D, the detachable barrier 96 preferably includes:

A buffer part 99.

A first glue part 100 attaching the buffer part 99 to sheet 93.

A second glue part 101 attaching the buffer part 99 to closure sheet 17.

Preferably, the first glue part 100 uses a glue that is weaker than the glue of the second glue part 101. Alternatively, the area of the first glue part 100 is smaller than the area of the second glue part 101. Thus, when a user peals of the time-monitoring tag 91 from the closure sheet 17, the first glue part 100 detaches from sheet 93 before the second glue part 101 detaches from closure sheet 17, as seen in Figs. 16A-16D.

Reference is now made to Fig. 17A and Fig. 17B, which are simplified illustrations of a time-monitoring tag 102 before and after pealing, according to a preferred embodiment of the present invention.

Time-monitoring tag 102 is similar to time-monitoring tag 91 of Fig. 15 with a blend- delay medium 103 replacing the inhibitor material of time-monitoring tag 91. The blend-delay medium 103 preferably includes a mesh material between the containers 94 and 95, or an array of tubes or a similar flow controlling mechanism. The width of the blend-delay medium 103 or the diameter of the tubes or a similar mechanism delays the flow of the materials in containers 94 and 95 towards each other and/or their blending. As seen in Fig. 17 A, the width of the blend-delay medium 103 increases along the length of the time-monitoring tag 102, as indicated by arrow 104.

Reference is now made to Fig. 18A, Fig. 18B, and Fig. 18C, which are simplified illustrations of a three- stage detachment mechanism 105, according to a preferred embodiment of the present invention.

The three- stage detachment mechanism 105 is similar to the detachable barrier 96 of Figs. 16A-16D and can replace it in the time-monitoring tags 91 or 102 of Figs. 15 or 17A and 17B. The three-stage detachment mechanism 105 preferably includes a buffer medium 106, a first glue part 107, a second glue part 108 and a thirds glue part 109.

Preferably, the first glue part 107 attaches the sheet 110 of the containers 94 and 95 to the sheet 93 of the time-monitoring tags 91 or 102 of Figs. 15 or 17A and 17B. The second glue part 108 attaches the other side of sheet 110 to the buffer medium 106. The third glue part 109 attaches the buffer medium 106 to the closure 17 covering the covering the opening of a blister as shown and described with reference to Fig. 2.

Preferably, the glue of the first glue part 107 is weaker than the glue of the second glue part 108 and the glue of the third glue part 109 is stronger than the glue of the second glue part 108. Therefore, when the time-monitoring tag is pealed, the first glue part detaches first, then the second glue part detaches, and later the third glue part detaches. Alternatively, as shown in Figs. 18A-18C, the area of the first glue part 107 is smaller than the area of the second glue part 108, and the area of the third glue part 109 is larger than the area of the second glue part 108.

Fig. 18A shows the three-stage detachment mechanism 105 closed (first stage), before the time-monitoring tags 91 or 102 are pealed open by a user to expose the opening of a blister as shown and described with reference to Fig. 2.

Fig. 18B shows the second stage with the time-monitoring tag slightly pealed away from the closure 17. This is causes the first glue part 107 to detach, thus enabling the materials in containers 94 and 95 to blend.

Fig. 18C shows the third stage with the time-monitoring tag fully pealed. This is causes the second glue part 107 to detach, thus exposing the time-monitoring tag to the user.

Reference is now made to Fig. 19A and Fig. 19B, which are simplified illustrations of a time-monitoring tag 111 according to a preferred embodiment of the present invention.

Time-monitoring tag 111 is similar to monitoring marker 19 of Fig. 2 and is operated in a similar manner. However, time-monitoring tag 111 preferably includes a container 112 containing a trickling fluid 113, a detachable barrier 114, and a seeping medium 115. Fig. 19A shows time-monitoring tag 111 before it is peeled from the closure sheet 17 of Fig. 2 and Fig. 19B shows time-monitoring tag 111 after it is peeled from the closure sheet 17.

As seen in Figs. 19A and 19B, when the monitoring tag 111 is closed and attached to the closure sheet 17 of Fig. 2 the detachable barrier 114 closes the opening between the container 112 and the seeping medium 115. When the monitoring tag 111 is opened, the detachable barrier 114 is detached from the closure sheet 17 and the opening between the container 112 and the seeping medium 115 is cleared. Thus, the trickling fluid 113 starts to flow through the seeping medium 115 (as seen in Fig. 19B) changing its color and/or transparency.

Referring to time monitoring tags 102, 111 as well as similar tags using a flow delay mechanism such as blend-delay medium 103 and/or seeping medium 115, it is appreciated that the grated time delay, for example from 1 to 24 hours, can be achieved, for example, by increasing the cut area of the seeping medium 115, as shown in Figs. 19B and 19B. Alternatively or additionally, the rate of flow trough the flow delaying medium can be achieved by using a suitable density of mesh material, or pipes of suitable diameter, and/or suitable materials affecting flow such as hydrophilic and hydrophobic coatings, greasy, absorbent and/or viscous materials, etc. For example, different such mechanisms and/or materials can be arranged along the length of the time monitoring tags to achieve linear or non-linear time measurement.

Reference is now made to Fig. 20, which is a simplified illustration of a time monitoring tag 116 according to a preferred embodiment of the present invention.

Time monitoring tag 116 is similar to time monitoring tags 111 but includes a series of flow delay elements 117. As seen in Fig. 20, the time delay elements 117 have a different length (with respect to the direction of the flow) to achieve non-linear time measurement (i.e. the time gratings are further apart at the beginning and closer at the end of the 24 hour timeframe).

Reference is now made to Fig. 21A, Fig. 21B, Fig. 21C, Fig. 21D, and Fig. 21E, which are simplified illustrations of various views of a time-monitoring tag 118, according to a preferred embodiment of the present invention.

Time-monitoring tag 118 is similar to time-monitoring tag 102 with a different activation mechanism 92. As shown in Figs. 21A-21E, time-monitoring tag 118 includes a pair of detachable barriers 96. A first detachable barriers 96 is mounted between container 94 and the blend-delay medium 103, and a second detachable barriers 96 is mounted between container 95 and the blend-delay medium 103.

Fig. 21A shows the front side of the time-monitoring tag 118. Fig. 21B-21D show a cut through time-monitoring tag 118, such as the cut designated by numeral 119 in Fig. 21A. Fig. 21B shows the time-monitoring tag 118 attached to closure 17 covering the blisters, such as shown and described with reference to Figs. Fig. 18A-18C, before it is pealed by a user to enable the user to access the closure 17 covering a blister. Fig. 21C shows the time- monitoring tag 118 partly detached from closure 17 as it is being pealed by a user, thus enabling the material in the containers to access the blend-delay medium 103. Fig. 21 D shows the time-monitoring tag 118 detached from closure 17. Fig. 21E shows a detail of the detachable barriers 96. As shown in Figs. 21B-21E, the time-monitoring tag 118 preferably includes a sheet 120 creating the envelope for the containers 94 and 95, and covering the blend-delay medium 103. The detachable barriers 96 include:

A first glue part 121 attaching sheet 120 to sheet 93 creating a barrier between the material in the container 94 or 95 and the blend-delay medium 103.

A second glue part 122 attaching the other side of sheet 120 to a buffer part 123, preferably rigid.

A third glue part 124 attaching buffer partl23 to sheet 17.

Preferably, the first glue part 121 uses a glue that is weaker than the glue of the second glue part 122 and the third glue part 124 uses glue stronger than the glue of the second glue part 122. Alternatively or additionally, the area of the first glue part 121 is smaller than the area of the second glue part 122 and the area of the third glue part 124 is larger than the area of the second glue part 122. Thus, when a user peals of the time-monitoring tag 118 from the closure sheet 17, the first glue part 121 detaches from sheet 93 before the second glue part 122 and the third glue part detaches last.

Reference is now made to Fig. 22A and Fig. 22B, which are simplified illustrations of a battery-operated time-monitoring tag 125 according to a preferred embodiment of the present invention, and to Fig. 23A, Fig. 23B, Fig. 23C, and Fig. 23D, which are simplified illustrations of four views of an activation switch 126 for the battery-operated time- monitoring tag 125 according to a preferred embodiment of the present invention

As seen in Figs 22A and 22B, battery-operated time-monitoring tag 125 preferably includes:

A base sheet 127, which may be the aluminum sheet covering the opening of a blister in a blister pack, such as shown and described above. Alternatively, base sheet 127 can be attached over the aluminum sheet.

An electric battery 128, preferably encircling the opening 129 of the blister.

A battery charge meter 130, preferably encircling the battery 128, and having measuring electrodes 131 and 132.

Activation switch 126.

Activation strip 133, preferably made of electrically insulating material. As seen in Figs 22A and 22B, the electrodes 131 and 132 of charge meter 130 create a spiral with a growing distance between the electrodes. The volume between the electrodes contains a material that produces color or light depending on electric current flowing through the material. Adequate material can be a combination of thermochromic ink and electrical conductive ink. Thermochromic ink is typically but not exclusively made of liquid crystal and/or leucodye.

The width of the spiral affects its resistance thus affects heat produces by the conductive ink at every point along the spiral. The heat affects the color or transparency of the thermochromic ink at each point. If the battery 128 is charged to provide sufficient current or voltage the area between the electrodes from electrode 131 (the spiral's narrowest point) to point such as point 134 of Fig. 22B is lit (or has a distinct color, or has a different transparency).

As seen in Fig. 22B, when a user punctures the aluminum foil covering the blister to access the medicine stored in the blister the user peals the activation strip 133 from the activation switch 126, thus connecting the meter 130 to the battery 128 and initiating the time measurement process.

Fig. 23A shows a front view of the activation switch 126 before activation. Fig. 23B shows a front view of the activation switch 126 after activation. Fig. 23C shows a side view of the activation switch 126 before activation. Fig. 23D shows a side view of the activation switch 126 after activation.

As seen in Figs. 23A-23D, activation switch 126 preferably includes:

The two edges of the battery 128 connected to electrodes 135 and 136.

The edge of activation strip 133.

An optional resistor 137 or a similar electric device.

A spring 138, or similar means.

As seen in Figs. 23B and 23D, the activation strip 133 provides insulation between electrodes 135 and 136 and between electrodes 135 and 136 and electrodes 131 and 132. As seen in Figs. 23B and 23D, when the activation strip 133 is pulled out of the activation switch 126, the spring attaches electrodes 131 to electrode 135, and electrode 132 to electrode 136, as well as resistor 137 across battery 128. Thus, resistor 137 discharges battery 128, and meter 130 measures the charge status of battery 128.

Reference is now made to Fig. 24A and Fig. 24B, which are simplified illustrations of a battery-operated time-monitoring tag 139, according to a preferred embodiment of the present invention.

Battery-operated time-monitoring tag 139 is similar to battery-operated time- monitoring tag 125 with a different type of battery charge meter. As seen in Figs. 24A and 24B, electrodes 131 and 132 spiral around battery 128 with a growing distance between the electrodes 131 and 132. A plurality of voltage meters 140 is preferably mounted between the electrodes 131 and 132 connecting between them. Each voltage meter preferably includes a resistor element 141 and a display element 142. The resistor element 141 can be made for example from conductive ink, and the display element 142 can be made for example from liquid crystal. The resistance of the resistor element 141 increases with its length. Thus, display elements 142 embedded with longer resistor elements 141 lit when battery 128 provides high enough voltage.

As battery 128 discharges the voltage decreases and only voltage meters 140 having short enough resistor element 141 can light up, as shown in Fig. 24B for voltage meters designated 143 and 144 and the voltage meters between them.

Thus, time-monitoring tag 139 measures the discharging of its battery 128 and indicates the time elapsing since the user punctured the foil covering the blister to access the medicine stored in the blister, pealing the activation strip 133 from the activation switch 126, thus connecting battery 128 to voltage meters 140 and initiating the time measurement process. For example as shown and described with reference to Figs. 23A-23D.

Preferably, the monitoring markers or tags such as markers 11, 31, 34, 36, 39, 42, 47, 51, 57, 69, and tags 91, 102, 111, 118, 125, and 139 are adapted for manufacturing by printing technologies such as ink-jet printing, laser printing, rotary printing press, offset printing, etc.

It is appreciated that various combinations of the features described above with respect to all the types of monitoring markers described with reference to Figs. 1 to 24B are possible and contemplated. It is expected that during the life of this patent many relevant methods and systems will be developed and the scope of the terms herein, particularly of the terms "blister" or "blister pack", or "closed cavity", or "closed compartment", or "sealed cavity" , or "sealed compartment" are intended to include all such new technologies a priori.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Claims

CLAIMS What is claimed is:

1. Means for identifying time as of the opening of a closure said means comprising: means for activating said time identification process upon said opening of said closure; and

means for displaying a code associated with time elapsing from said activation.

2. Means for identifying time as of the opening of a closure according to claim 1 wherein said means is operative to identify that said opening occurred within a predetermined period prior to checking said means.

3. Means for identifying time as of the opening of a closure according to claim 1 wherein said code comprises at least one of change of color and change of opacity.

4. Means for identifying time as of the opening of a closure according to claim 3 wherein said code comprises change of area of said at least one of color and opacity.

5. Means for identifying time as of the opening of a closure according to claim 3 wherein said change of color comprises at least one of increasing and fading said color.

6. Means for identifying time as of the opening of a closure according to claim 1 wherein said means comprises a part of a blister pack for medications; wherein said opening comprises the opening of a single blister; wherein said activation is associated with said opening of said single blister; and wherein said code is associated with time passing since said opening of said single blister.

7. Means for identifying time as of the opening of a closure according to claim 1 wherein said activation initiates exposure to at least one of air, oxygen, humidity and light.

8. Means for identifying time as of the opening of a closure according to claim 1 wherein said activation initiates at least one of evaporation and sublimation.

9. A tag for identifying time as of opening a blister of a blister package, said tag comprising:

a detachment part for activating a time identification process upon said opening of said blister; and

a time measuring part for displaying a code associated with time elapsing from said activation.

10. A tag according to claim 1 wherein said tag is operative to identify that said opening occurred within a predetermined period prior to checking said tag.

11. A tag according to claim 1 wherein said code comprises at least one of change of color and change of opacity.

12. A tag according to claim 3 wherein said code comprises change of area of said at least one of color and opacity.

13. A tag according to claim 3 wherein said change of color comprises at least one of increasing and fading said color.

14. A tag according to claim 1 wherein said means comprises a part of a blister pack for medications; wherein said opening comprises the opening of a single blister; wherein said activation is associated with said opening of said single blister; and wherein said code is associated with time passing since said opening of said single blister.

15. A tag according to claim 1 wherein said activation initiates exposure to at least one of air, oxygen, humidity and light.

16. A tag according to claim 1 wherein said activation initiates at least one of evaporation and sublimation.

17. A tag according to claim 1 wherein said activation initiates an electric contact.