Apparatus and method for improved drug regimen compliance

RELATED APPLICATION This application claims priority to U.S. Provisional Patent Application No. 62/320,234 (Attorney Docket Number: 3005-004PR1) filed April 8, 2016, which is incorporated herein by reference. incorporated.

Drug non-adherence is a major problem in many ways, from rising healthcare costs to financial losses for the pharmaceutical industry to severe negative human impacts.

125,000 people die each year in the United States as a result of non-adherence to medication regimens.

Studies show that the health care impact of drug non-adherence is $290 billion annually.

The global pharmaceutical market is losing an estimated $564 billion annually to non-compliance, losing 59% of the total global pharmaceutical sales of $956 billion in 2011.

Adherence to long-term therapy among the general population is approximately 50% in developed countries and much lower in developing countries.

Nearly three in four Americans do not take their medications as directed, with serious health consequences, especially for those with chronic conditions.

In the case of oral contraceptives (OCPs), the need to properly follow a dosing regimen is particularly important. For example, in addition to the problems described above, failure to follow proper prescription of OCP has already resulted in many unwanted pregnancies and may lead to many more. OCP is one of the most common contraceptives, especially among young women. A government report released October 18, 2012 provides the following statistics for the United States: 62% of women of reproductive age are currently using contraception. Among the women who used contraception during the month of the interview, the most common methods were the pill (28%, or 106 million women) and sterilization (27%, or 102 million women). women). Although intrauterine device use as the current method has increased since 1995 (from 0.8% in 1995 to 5.6% between 2006 and 2010), condom use by partners remains the most effective method of contraception today. Few women reported that they Among women at risk of unintended pregnancy, 11% reported not currently using a method of contraception.

A United Nations report published in 2011 provided the following statistics worldwide: In developed countries, the most commonly used method is the pill (18 years of married women of reproductive age). % use) and male condoms (18% prevalence). These two methods account for half of all contraceptive use in developed countries. In contrast, in developing countries, the most prevalent methods are sterilization (21%) and IUDs (15%), accounting for 58% of total contraceptive use.

Missing a pill is one of the main reasons women on OCP seek emergency contraception (eg, the morning after pill). Therefore, poor compliance is the main cause of unintended pregnancies in these women. Studies suggest that 47% of women worldwide have poor medication adherence and do not take the pill more than once per cycle (average menstrual cycle is 28 days). The UK's largest OCP manufacturer, Schering Health Care Ltd, reports that the average woman forgets to take her pill eight times a year. Most people know that they need to take corrective action when they forget their pills, but few know anything. Only 10% of people know that skipping one pill poses a risk of pregnancy.

The success of OCP is closely tied to following a prescribed daily regimen, ie taking the correct pills on the correct days during a woman's menstrual cycle. For this reason, oral contraceptives are packaged in blister cards with a printed calendar to guide the patient as to which pill to take on which day. Additionally, the recommended daily dosing interval is 24 hours. For this reason, many users use daily reminders (eg, on mobile devices) to maintain compliance. In the event of patient non-compliance, the manufacturer recommends specific actions to restore compliance and reduce the chance of unintended pregnancies in the interim. Unfortunately, recommended intervention methods are not always followed correctly, increasing the risk of unwanted pregnancies.

A packaging approach that provides one or more of: improved patient adherence/compliance, treatment outcome, authentication, packaging and distribution approach would be a welcome advance for the pharmaceutical industry and would improve OCP regimen compliance, and other drug regimens.

The present invention enables tracking of adherence to medication regimens, such as pharmaceutical prescription regimens, through connected smart packaging. Embodiments of the present invention are particularly suitable for improving adherence to oral contraceptive pill regimens.

<p>Embodiments of the present invention allow the status of blister cards to be automatically monitored, thereby allowing adherence to medication regimens to be tracked and/or improved. In some embodiments, the condition of the blister card is automatically evaluated periodically and compared to previous conditions to determine whether tablets have been dispensed during the intervening period. In some embodiments, the act of dispensing a tablet generates an output signal that allows the dispensing event to be automatically recorded. The history of dispensing events is then compared to the prescribed dosing regimen of the drug contained in the blister card to assess whether the dispensing events are as prescribed. If an error (i.e., non-conformance) in the dispensation history is detected, the user and/or one or more designated persons in the user's circle of care (e.g., caregivers, nurses, doctors, clinics/hospitals, (parents, partners, relatives, friends, etc.) will be alerted.</p><p>An embodiment of the invention includes a package comprising a housing that contains and positions a blister card containing a plurality of pharmaceutical tablets. The package contains a detection module with a plurality of sensors arranged to match the arrangement of tablets on the blister card. As a result, each tablet position is operatively associated with a different sensor. As tablets are dispensed, each sensor operates to provide an output signal indicative of a dispensing event and compares the blister card's dispensing history with the prescribed dosing regimen.</p><p>An exemplary embodiment of the invention is a package comprising a housing containing a sensing module comprising a plurality of capacitive sensors each comprising a sensing electrode. When the blister card is placed in the housing, the blister card and detection module determine that the electrodes of the lid foil and respective sensors in the dispensing area of each tablet location collectively determine the physical state of the dispensing area. is operably connected to define a capacitor based on A change in this capacitance indicates that the tablet at that sensor location has been dispensed.</p><p>In some embodiments, the detection module includes multiple capacitive sensors that are shielded from external noise and interference. In some of these embodiments, the sensing electrodes are shielded from stray capacitance and electrical noise originating from the other side of the blister card by drive electrodes positioned between the sensing electrodes and the dispensing area. The drive and sense electrodes are characterized by mutual capacitances influenced by fringing fields based on the physical conditions of their respective distribution regions. In some embodiments, the sense electrode is between a pair of drive electrodes. The drive electrodes shield the sense electrodes from stray capacitance and electrical noise received from the top and bottom surfaces of the blister card/detection module arrangement. In some embodiments, the sensing electrode is substantially surrounded in-plane by a grounded shield wire. As a result, the sensing electrodes are further shielded from side-directed electrical noise and stray capacitance.</p><p>In some embodiments, the package includes a detection module that uses sensing technology other than capacitive sensing. In some embodiments, the detection module includes an optical sensor. In some embodiments, the detection module includes an acoustic sensor. In some embodiments, the sensing module includes a tactile sensor.</p><p>In some embodiments, the package is operatively linked with an accompanying mobile application to assist women relying on OCP with better adherence to prescribed medication regimens and better management of efficacy requirements. have.</p><p>One embodiment of the present invention is for monitoring the condition of a blister card comprising a forming film, a lidding film, and a first tablet contained within a first reservoir defined by the forming film and the lidding film. A system comprising: a housing operable to position a blister card in a first position; (a) the presence of a first tablet in a first reservoir; a detection module comprising a first sensor operable to provide a first electrical signal based on at least one physical condition of the dispensing area of the and providing a first output signal based on the first electrical signal and an electronics module operable to:</p><p>Another embodiment of the invention is a system for monitoring the condition of a blister card comprising a forming film, a lidding film and a plurality of tablets arranged in a first array, the system comprising: a detection module comprising a plurality of sensors arranged in said first array, the sensors operable to provide electrical signals based on physical conditions of different dispensing areas of the lidding film; and an output signal based on the plurality of electrical signals. and an electronics module operable to provide</p><p>Yet another embodiment of the present invention is a method of monitoring the condition of a blister card comprising a forming film, a lidding film and a plurality of tablets arranged in a first array, the method comprising: and each sensor of the plurality of sensors is operable to provide an electrical signal based on the presence of a different one of the plurality of tablets in the blister card. operably coupling the plurality of sensors and the blister card; determining a physical state of the blister card based on the plurality of electrical signals; providing an output signal based on the physical condition of the blister card for the desired conditions, the step of comparing wherein the desired conditions are based on a predetermined prescribed dosing regimen for the plurality of tablets; and the step of</p>

<figref num="1">1 shows a block diagram of a package according to an exemplary embodiment of the invention; FIG.</figref><figref num="2A">1 shows a schematic representation of a perspective view of a blister card 102. FIG.</figref><figref num="2B">1 shows a schematic representation of a cross-sectional view of a blister card 102. FIG.</figref><figref num="3">4 illustrates operation of a method for monitoring a medication regimen in accordance with an exemplary embodiment;</figref><figref num="4">1 shows a schematic representation of a perspective view of the package 100 with the blister card 102 inserted.</figref><figref num="5">An enlarged cross-sectional view of a portion of an alternative receiver 106 is shown.</figref><figref num="6A">FIG. 4 is a schematic diagram of a top view of a capacitive sensing module in accordance with an exemplary embodiment of the invention;</figref><figref num="6B">FIG. 4 is a schematic diagram of a cross-sectional view of a capacitive-sensing detection module in accordance with an exemplary embodiment of the invention;</figref><figref num="7">FIG. 4 shows a cross-sectional view of an alternative capacitive sensor with improved noise immunity according to the present invention;</figref><figref num="8">A schematic diagram of the electrical connections of the sensor 700 is shown.</figref><figref num="9">FIG. 4 shows a cross-sectional view of another alternative capacitive sensor with improved noise immunity according to the present invention;</figref><figref num="10">A schematic diagram of the electrical connections of the sensor 900 is shown.</figref><figref num="11">FIG. 4 shows a plan view of a detection module with improved noise immunity due to shielding lines formed around each of the sensing electrodes.</figref><figref num="12A">Measurements of two individual sensors 900 in response to the sequential dispensing of two tablets from the blister card 102 are shown.</figref><figref num="12B">Measurement results of two individual sensors 900 in response to sequential administration of two tablets from blister card 102 are shown.</figref><figref num="13A">FIG. 4 shows a schematic diagram of a cross-sectional view of package 100 with another capacitive sensing module.</figref><figref num="13B">FIG. 13 shows a cross-sectional view of part of the detection module 1300 prior to tablet dispensing according to the present invention.</figref><figref num="13C">FIG. 13 shows a cross-sectional view of part of the detection module 1300 after tablet dispensing according to the present invention.</figref><figref num="13D">Fig. 3 shows a cross-sectional view of a portion of yet another capacitive sensing module prior to tablet dispensing according to the present invention;</figref><figref num="13E">Fig. 3 shows a cross-sectional view of part of yet another capacitive detection module after dispensing of tablets according to the present invention;</figref><figref num="14A">Fig. 3 shows a cross-sectional view of part of an alternative acoustic detection module prior to tablet dispensing according to the present invention;</figref><figref num="14B">Fig. 2 shows a cross-sectional view of part of an alternative acoustic detection module after dispensing of tablets according to the present invention;</figref><figref num="15">Fig. 2 shows a schematic diagram of a perspective view of a blister card with multiple microphones according to another acoustically sensitive embodiment of the present invention;</figref><figref num="16A">Fig. 3 shows a cross-sectional view of part of a tactile detection module prior to tablet dispensing according to the present invention;</figref><figref num="16B">Fig. 3 shows a cross-sectional view of part of a tactile detection module after dispensing of a tablet according to the invention;</figref><figref num="17A">Figure 2 shows a cross-sectional view of part of a photosensitive detection module prior to tablet dispensing according to the present invention;</figref><figref num="17B">Fig. 3 shows a sectional view of part of a photosensitive detection module after dispensing of tablets according to the invention;</figref><figref num="18A">Figure 2 shows a cross-sectional view of part of a photosensitive detection module prior to tablet dispensing according to the present invention;</figref><figref num="18B">Fig. 3 shows a sectional view of part of a photosensitive detection module after dispensing of tablets according to the invention;</figref><figref num="19">FIG. 3 shows a schematic representation of a perspective view of a multi-blister card package according to another embodiment of the present invention;</figref>

The present invention is directed in part to a connected packaging solution for pharmaceuticals, focusing in part on pharmaceutical containers including blister cards. Although the focus of this specification is on OCPs, it should be noted that the invention may be directed to blister card-based packaged products. For the purposes of this specification, including the appended claims, the term "tablet" means any and all of a variety of medicinal products including, but not limited to, pills, capsules, powders, gelcaps, etc. defined as Some of the embodiments described herein utilize concepts developed for connected packaging solutions targeted at "blister cards," dated Oct. 9, 2015. No. 14/879,874 (Attorney Docket No.: 3005-002US1) entitled "Connected Packaging," filed on May 20, 2005 and incorporated herein by reference.

FIG. 1 shows a block diagram of a package according to an exemplary embodiment of the invention. The package 100 monitors the status of the OCP blister card 102, enables tracking of the regimen of tablets contained, communicates messages to the user and/or caregiver, etc., and has smart packaging capabilities for oral contraceptive protection. is the case. Package 100 includes housing 104 , receiver 106 , detection module 108 and electronics module 110 . The package 100 is sized and arranged to accommodate a conventional "push-through pack" blister card containing a 28-day administration of oral contraceptive tablets, such that the blister card is operatively coupled with the detection module. to place

2A and 2B show schematic diagrams of perspective and cross-sectional views of blister card 102, respectively. Blister card 102 is a conventional blister card including forming film 202 , lidding film 204 , reservoir 206 and tablet 210 .

Molded film 202 is a layer of thermoformed plastic with cavities 208 formed therein.

Lid film 204 is a thin sheet of aluminum foil. In some embodiments, the lidding film 204 is another sheet of conductive material. In some embodiments, lidding film 204 includes a sheet of electrically conductive material and a sheet of electrically insulating material such as a paper sheet (with a printed calendar or instructions), polymer, or the like. After tablet 210 is dispensed into cavity 208 , lidding film 204 is combined with forming film 202 to seal the cavity, thereby forming reservoir 206 . Typically, a calendar describing the dosing regimen is printed on the card and/or provided as part of the blister card.

The area of the lidding film 204 underlying each cavity defines a dispensing area 212 from which each tablet 210 is dispensed by pushing the tablet through the lidding foil.

FIG. 3 illustrates operations of a method for monitoring a medication regimen in accordance with an exemplary embodiment. Method 300 begins with operation 301 of placing blister card 102 in package 100 . Method 300 will be described with continued reference to FIGS. 1 and 2A-B.

FIG. 4 shows a schematic diagram of a perspective view of the package 100 with the blister card 102 inserted.

Blister card 102 is protected from damage and unintended tablet dispensing by housing 104 when installed in package 100 . Housing 104 is strong enough to protect blister card 102 from damage during normal handling and storage, such as might occur if blister card 102 were placed in a wallet or pocket without such protection, for example. It is an injection molded plastic case with

The position of blister card 102 within package 100 is determined by receiver 106 (ie, receiver 106 locates blister card 102). Receiver 106 is a rigid frame that includes an opening to expose reservoir 206 of blister card 102 . To place the blister card 102 within the housing 104, the blister card is placed into a seat formed in the bottom of the housing 104 (not shown) and a receiver 106 is placed on the blister card to capture the blister card in place. is closed. Receiver 106 is sized and positioned to provide pressure distributed over the surface of the blister card to ensure operative coupling with detection module 108 .

In some embodiments, the blister card 102 includes information printed on its forming film side (eg, instructions for the user, advertisements, logos, etc.). In such embodiments, the packaging member (eg, receiver 106) placed over the printed information may be made of an optically transparent material.

In some embodiments, the receiver 106 includes a different conventional latching system for positioning the blister card within the housing 104 so as to be operably coupled with the detection module 108.

FIG. 5 shows an enlarged cross-sectional view of a portion of an alternative receiver 106. FIG. The cross-sectional view shown in FIG. 5 is taken through area 406 of FIG. Receiver 106 includes a plurality of latches 502 and shoulders 504 formed as part of the outer wall of housing 104 . Latch 502 is a deformable tab that can be depressed to allow blister card 102 to be secured against shoulder 504 . The tabs are resilient such that when the blister card is in proper position against the shoulder, it springs outward to lock the blister card in this position. In an exemplary embodiment, the desired position of blister card 102 abuts the top surface of detection module 108, as described below. Typically, latch 502 and shoulder 504 are formed as part of the sidewall of housing 104 according to conventional injection molding techniques. Those skilled in the art will appreciate that there are myriad conventional methods for forming receiver 106, and the receiver designs shown in FIGS. 4 and 5 are merely examples of receivers suitable for use with the present invention. would recognize

The detection module 108 is a two-dimensional array of sensors that substantially matches the arrangement of the tablets 210 on the blister card 102 . In some embodiments, detection module 108 includes a mechanically robust plate that includes multiple holes through which tablets 210 are dispensed. As described below, detection module 108 uses capacitive sensing technology to monitor the condition of blister card 102 . However, after reading this specification, it will be apparent to those skilled in the art that many alternative sensing techniques can be employed in detection module 108 without departing from the scope of the present invention. Sensing technologies suitable for use with embodiments of the present invention include, but are not limited to, optical sensing, acoustic sensing, and tactile sensing, among others. The detection module 108 is described in more detail below.

Electronics module 110 is an electronic package operably coupled with detection module 108 . The electronics module 110 provides electronics suitable for interfacing with the sensors of the detection module, signal conditioning electronics (e.g., preamplifiers, comparators, etc.) for receiving the output signal of each sensor, and the output signal 112. including output electronics, etc. In some embodiments, the electronics module 110 includes, but is not limited to:

1. communication electronics (wired and/or wireless, e.g. Bluetooth, cellular, etc.), or 2. processing capabilities, or 3. memory, or 4. on-board clock circuitry, or 5. power (e.g. battery etc.) and/or power generating electronics, or 6. sensor interface circuitry, or 7. wake-up detection circuitry, or 8. on alerts (e.g. light emitting diodes, buzzers, etc.), or 9. environmental (e.g. temperature, humidity, shock, Geolocation, etc.) sensors, or any combination of 10.1, 2, 3, 4, 5, 6, 7, 8, and 9

In the illustrated example, electronics module 110 wirelessly communicates with mobile device 114 via output signal 112 and input signal 116 .

Mobile device 114 is a cell phone that runs software applications (ie, mobile applications) that provide assistance to patients and/or caregivers in achieving and maintaining good adherence to prescribed medication regimens. In some embodiments, electronics module 110 communicates with different devices such as computers and/or base stations. Additionally, in some embodiments, the electronics module 110 is integrated with the detection module 108 on the same substrate.

In some embodiments, the electronics module 110 includes sleep mode circuitry to facilitate long battery life between charges. In such embodiments, sensing is activated only when desired and the instrument is in sleep mode most of the time. Examples of sleep mode circuitry suitable for use with embodiments of the present invention include, but are not limited to, low power accelerometers, touch/proximity sensors, and the like.

Those skilled in the art will appreciate from reading this specification that the design features of housing 100, as well as the sensing technology used to monitor its condition, are based on the specific placement of blister card 102. will recognize. As a result, the design details provided herein are merely exemplary, and a myriad of alternative designs are possible without departing from the scope of the invention.

In the package configuration illustrated in FIG. 4, detection module 108 and electronics module 110 are embedded within the bottom surface of housing 104 . However, it should be noted that there are many ways to integrate detection module 108 and/or electronics module 110 within housing 104 without departing from the scope of the present invention. For example, in some embodiments of the invention, detection module 108 is embedded in the bottom of housing 104 and electronics module 110 is attached to lid 402 . Wiring (not shown) embedded in housing 104 passes through hinge 404 and electrically couples the detection and electronics modules. In another embodiment, housing 104 includes another compartment for housing electronics module 110 . In some embodiments, detection module 108 and electronics module 110 are disposed in or on one or more printed circuit boards (PCBs) attached to housing 104 (ie, a hybrid implementation).

In some embodiments, electronics module 110 includes a touch display disposed on housing 104 to enable direct user interaction via displayed text, graphics, user input, etc. .

Although the present disclosure provides electronics/sensing/display functionality by placing suitable electronics or the like in or on the case, any or all of such functionality is beyond the scope of the present invention. can be provided by integration into the blister card itself.

At operation 302, the electronics module 110 monitors the time and date via the on-board clock. In some embodiments, mobile device 114 monitors the time and date. In some embodiments, electronics module 110 requests time and date information from mobile device 114 . In some embodiments, time and date are tracked in other conventional ways.

In operation 303 the condition of the blister card 102 is monitored. Those skilled in the art will recognize that the method of determining the condition of the blister card 102 is based on the sensing technology used. As briefly mentioned above, many sensing techniques can be used to sense the status of the blister card, and examples of some sensing methods are described in detail below.

At operation 304, the condition of the blister card 102 is compared to the regimen of the prescription drug (ie, tablet 210) contained therein. In an exemplary embodiment, this comparison is performed periodically (eg, every minute, every hour, hours, etc.) during the intended 28-day dosing period. In the illustrated example, the predetermined regimen is maintained within a mobile application running on mobile device 114 and provides regimen data to electronics module 110 via input signal 116 . In some embodiments, the regimen is downloaded to a memory module contained within electronics module 110 . In some embodiments, the output signal 112 provides blister card status information to the mobile device 114, which compares it to the regimen.

In one aspect of the present invention, the blister card's ability to automatically record dispensing events enables improved software, such as mobile apps, to assist users in adhering to prescribed medication regimens. Currently, there are many mobile phone- and computer-based applications that use automatic calendar reminders to aid in OCP compliance. These applications typically track adherence and provide functionality for some degree of management of effectiveness requirements, as well as the fundamentals for achieving and maintaining good adherence and managing effectiveness requirements. An outline of the methodology is shown.

Traditional OCP apps typically start with a stage configuration when the app is first downloaded. The configuration step usually requires the user to enter a few bits of personal information, for example:

.Login information .Privacy agreement (agree or disagree) .Cycle length (only when the user launches the app for the first time) .Start date of the last period (only when the user launches the app for the first time) , the number of days since starting the current card (only the first time the user launches the app), and daily reminder settings: time or time window to take the pill, reminder type: alarm, text, or e-mail, customize reminder message (eg "take the pill"), activate snooze, and alarm type (eg sound).

Once the app is set up, daily usage includes reminder notifications to take the correct pill at the right time (or within the right time window). After taking the pill, the user manually enters the time, date, and pills taken into the app. Time-date-pill data is stored and can be accessed by the user to analyze adherence. Adherence data and trends can also be forwarded to one or more designated persons within the user's circle of care.

A fundamental limitation of these mobile apps is that users must manually enter all of the required data, as currently available apps do not have the ability to automatically capture actual compliance data. As a result, conventional OCP apps are cumbersome to use, frequently misused, and are most effective only for highly motivated patients.

Automated systems are known for tracking medication adherence via mobile apps. However, these are usually intended for drugs packaged in bottles. These conventional systems incorporate wireless connectivity and sensors to monitor and communicate compliance data within an accompanying mobile app and/or network server. If medication has not been delivered, the system automatically provides an alarm notification, either by the system itself or by a sign sent to the user's care circle via automatic call or text message. The ability to automatically generate reminder messages is an important step in supporting good adherence.

However, embodiments of the present invention include apparatus and methods that can further improve upon the conventional methods described above. These improvements are particularly suitable for OCP adherence, but are also suitable for many other medication adherence applications, especially those that are highly sensitive to quality of adherence. Specifically, the present invention can improve upon the prior art by enabling the following.

Monitors the distance between the device and the mobile device via Bluetooth radio signal range (e.g., up to about 20 meters) OCP creator instructions stored in a mobile app on the mobile device and from the device and provide compliance feedback to the device itself via a mobile app.

As a result, the present invention provides several significant advantages over prior art automated tracking systems. For example, the present invention allows monitoring the distance between the blister card 102 and the mobile device. This provides a monitoring capability that can determine if the blister card and mobile device are in the same general space (eg, home). As a result, for example, an alert can be sent to the user if the user leaves home without a pill. The shrillness of the reminder can be weighted in importance depending on whether the next dose is approaching (eg, one hour later or within the same day) or the next day. In some embodiments, information on the electronic calendar on the mobile device is accessed to determine the risk of misplacing a pill, for example, if an overnight trip is planned.

The ability to compare the OCP dosing regimen on the blister card 102 with the actual compliance information captured by the package 100 allows embodiments of the present invention to provide the user with recommended next steps. This is particularly advantageous when compliance is interrupted, such as when the user forgets to take the pill and is unsure how to best mitigate the risk of an unintended pregnancy.

In addition, the present invention allows compliance feedback, thereby helping users to adjust their behavior accordingly. Such feedback can also be provided to the user's care circle for necessary intervention to improve adherence. Further, in some embodiments, compliance feedback is stored in long-term memory at the monitoring site for use in long-term therapeutic treatment planning, litigation, civil litigation (e.g., paternity litigation, etc.), and the like. Can be used as evidence.

In some embodiments, the state of the blister card (eg, number of pills dispensed, which pills were dispensed, etc.) is saved upon case closure. At the next opening of the case, the condition of the blister card is checked again and compared with the last saved condition. This will detect any unexpected changes to the blister card and ask the user relevant questions through the mobile app. Additionally, the condition of the blister pack upon opening provides a basis for measuring changes in condition. In some embodiments, upon detection of an unexpected difference in the state of the blister pack when closed and opened, alarms, Generate an error flag or signaling.

Returning now to method 300 , if operation 304 reveals an inappropriate event, method 300 proceeds to operation 305 A and an error signal is initiated by electronics module 110 . Improper events that may initiate an error signal to the user or the user's circle of care include, but are not limited to:

1. The dosing time window has elapsed and the intended tablet 210 has not been dispensed, or 2. The wrong tablet 210 has been dispensed during the dosing time window, or 3. Time outside the proper dosing time window. or 4. two or more tablets 210 were dispensed, or any combination of 5.1, 2, 3, and 4.

Additionally, in some embodiments, if it is determined that it is time to dispense a tablet, but the tablet has not been dispensed, a reminder can be sent to the user to take the appropriate pill.

If in operation 304 it is determined that the correct tablet 210 was dispensed within its assigned dosing time window, the time at which the tablet was dispensed is recorded in memory by the electronics module 110 in operation 305B. Additionally, if the dispensed tablet was the last tablet in the blister card 102, the method 300 proceeds to operation 306 where a warning to the user or user's care circle is initiated and the blister card 102 is empty. be warned. In some embodiments, this alert is generated when the number of tablets in the blister card 102 drops to a threshold level and initiates a refill reminder to the user or user's care circle, or to a pharmacy directly. Generate replenishment requests.

If the blister card 102 is not empty, the method 300 continues repeating operations 302-306.

Mobile apps may incorporate additional features to help users better manage their health. For example, at operation 305B, the user may be given the opportunity to enter notes into the mobile app and/or benefits via the mobile, e.g., record side effects experienced, had sexual intercourse in the last 24 hours, etc. . At operation 305A, the mobile app may provide counseling and educational information to the user. Knowing the user's cycle points, the mobile app can provide contextual health and wellness information to the user.

Those of ordinary skill in the art, upon reading this specification, will realize that method 300 is one non-limiting exemplary method for improving dosing regimens, and that a myriad of alternative methods may be used without departing from the scope of the present invention. You will recognize that you can use

[Sensing method for monitoring the condition of blister card]

As mentioned above, many sensing techniques can be utilized to monitor the condition of the blister card, including capacitive sensing, acoustic sensing, optical sensing, thermal sensing, and tactile sensing. However, capacitive sensing techniques are particularly attractive for use with the present invention. Accordingly, in an exemplary embodiment, detection module 108 includes a plurality of capacitive sensors, as described herein.

[Capacitive Sensing]

6A and 6B are schematic diagrams of top and cross-sectional views of a capacitive sensing module according to an exemplary embodiment of the invention. Detection module 108 includes substrate 602, hole 604, and sensors 606-1 through 606-28 (collectively sensors 606).

Substrate 602 is a conventional PCB substrate. Substrate 602 is sized to fit into housing 104 to form the bottom of package 100 . Typically, substrate 602 is held to housing 104 via a receiver similar to receiver 106 described above. In some embodiments, substrate 602 is another substrate, such as a semiconductor wafer suitable for planar processing. In some embodiments, instead of a rigid substrate (e.g., substrate 602), detection module 108 is flexible and optionally visual, as described below with reference to FIGS. 13A and 13B. provided with a transparent substrate.

A hole 604 extends through the substrate 602 to allow each of the tablets 210 to pass through the detection module 108 when dispensed from the blister card.

Each sensor 606 comprises an electrode 608 and a respective distribution area 212 of lidding film 204 . Electrode 608 is a circular metal electrode that completely surrounds hole 604 . The electrodes 608 are formed within the body of the substrate 602, and when the blister card 102 is in contact with the detection module 108, the electrodes and lid film 204 form a capacitive sensor 606, whose capacitance is shown in FIG. Based on the condition of the lidding film in each dispensing area 212, as shown in 6B. In some embodiments, sensor 606 (and other sensors described herein) are formed directly on the bottom surface of housing 104, thereby eliminating substrate 602. FIG.

Each of the sensors 606 is electrically connected to the sensing circuitry of the electronics module 110 via electrical traces (not shown for clarity). As a result, each sensor can be monitored individually to allow identification of the dispensation of each tablet 210 on the blister card 102 . In some embodiments, sensors 606 are electrically connected and data obtained using a row/column addressing scheme.

OCP represents one of many applications where it is important to be able to identify when a tablet has been dispensed during a dispensing event. However, those skilled in the art will understand from reading this specification that not all drugs need to uniquely identify a dispensed tablet and, as a result, the sensing used to detect tablet dispensation It will be appreciated that the approach can be greatly simplified. For example, in some cases all tablets on a blister card are substantially identical. Therefore, in some embodiments of the invention, all of the sensors 606 are electrically connected in parallel or in series and cannot identify which tablet 210 has been dispensed. In some such embodiments, an accelerometer operably coupled with the blister card to detect dispense events, all of which are energized such that each dispense event is indicated by a change in the capacitance of a single capacitor. A single sensor is used, such as a single capacitive sensor spanning the position of the tablet.

Alternatively, in some embodiments, row/column sensing is such that one electrode of the capacitive sensor is common to an entire row or column of tablet locations, while the other electrode is site-specific individual electrodes. It simplifies to split row or column sensing.

In such an embodiment, depletion of the blister card (indicating it is due for refill) simply tracks dispensing events and compares their count to the total count of tablets on the blister card when presented. , or by monitoring the total magnitude of change in the sensor output signal on a dispensing event and detecting it in a number of ways, such as comparing the result to a reference magnitude change determined by a prior calibration run. can be done.

In each sensor 606, the conductive material of distribution region 212 (ie, lid film 204) forms a fringing field with electrode 608. FIG. These fringing fields affect the capacitance of the capacitive sensor, which gives a first value when the distribution region is intact. However, when tablet 210 is dispensed, breakage of dispensing area 212 changes the physical configuration between the lid film material and electrode 608, affecting the fringing fields and thus the capacitance of sensor 606. FIG. It should be noted that the capacitance of the sensor 606 will change depending on whether the material of the dispensing area 212 is completely ruptured or if debris is left hanging in the hole 604 thereafter.

To sense the capacitance of each sensor 606, lid film 204 is electrically grounded and each electrode 608 is connected to a high impedance detection circuit. In some embodiments, the lidding film 204 is electrically "floating", but it is preferred to have the lidding film in place as it improves the stability of the sensed signal and noise immunity. Unfortunately, sensor 606 can be sensitive to external noise and interference, such as stray or parasitic capacitance, electromagnetic interference (EMI).

In some embodiments, electrode 608 is split into a pair of half rings to mitigate the effects of noise and interference. In some embodiments, electrode 608 is divided into more than two circumferential portions. Using such an electrode configuration, capacitance sensing is performed by monitoring the change in capacitance between the electrode segments, which changes between the electrode segments and the aluminum foil over the holes. affected by the fringing electric field between Unfortunately, while segmented electrodes 608 provide some noise immunity, noise and interference can still be an issue.

FIG. 7 shows a cross-sectional view of an alternative capacitive sensor with improved noise immunity according to the present invention. Sensor 700 is suitable for use in detection module 108 and comprises substrate 602 , electrode 608 and electrode 702 . Sensor 700 has significantly improved noise immunity compared to sensor 606 .

Electrode 702 is similar to electrode 608 . However, electrodes 702 are formed in substrate 602 such that they are parallel to electrodes 608 and distal to lidding film 204 when blister card 102 is placed in package 100 . Electrodes 608 and 702 collectively define a parallel plate capacitor within substrate 602 .

Sensor 700 operates according to projected capacitive sensing technology as described in Microchip Application Note TB3064 entitled "mTouch Projected Capacitive Touch Screen Sensing Theory of Operation" published January 5, 2010. and is incorporated herein by reference.

FIG. 8 shows a schematic diagram of the electrical connections of sensor 700 .

In circuit 800, electrodes 608 and 702 collectively define capacitor C1, whose value is determined by the mutual capacitance between the electrodes.

Electrode 608 and lid film 204 collectively define capacitor C2, whose capacitance is determined by the fringing electric field between electrode 608 and lid film. These fringing fields are based on the state of the sensing region 212 .

Capacitance C3 is the touch capacitance between electrode 608 and the user's finger, which is applied while the user presses forming film 202 to push tablet 210 out of lid film 204, as described below. , and occurs only after the lid film in the dispensing area 212 breaks.

Electrode 608 is also characterized by a substantially fixed electrode capacitance C4.

Similarly, electrode 702 is characterized by its own substantially fixed electrode capacitance C5.

In operation, electrode 608 is driven as a transmitter and receives drive signal 802 from electronics module 110 . Electrode 702 acts as a receiver and provides an output signal 804 to sensing circuitry within electronics module 110, the output signal being based on mutual capacitance C1.

Before the tablet 210 is dispensed, the sensing area 212 is whole and the physical configuration of the respective elements is fixed so that the fringing capacitance C2 and the mutual capacitance C1 are substantially unchanged. Furthermore, the value of capacitor C3 is substantially zero because the intact lid film 204 within the sensing region 212 shields the electrode 608 from stray capacitance and electrical noise from the area on the opposite side of the lid film 204 from the electrode. be. In other words, the intact lid film 204 within the sensing region 212 acts as an "electrical shield" for the electrodes 608. FIG. For the purposes of this specification, including the appended claims, "electrical shielding" mitigates the effects of stray capacitance, electrical noise, and electrical interference on electrical parameters measured by other devices. Defined as an element.

However, when tablet 210 is dispensed, sensing region 212 breaks, changing the physical configuration between the conductive material of lid film 204 and electrode 608, and thus the fringing capacitance of capacitor C2. It also allows the creation of the capacitance of capacitor C3. A change in the configuration of the elements of C2 affects the mutual capacitance C1. Since the shielding ability of lid film 204 is compromised by breakage of distribution area 212, the value of C1 is further affected by the generation of touch capacitance C3. The resulting change in C1 is detected by the electronics module 110 sensing circuitry.

Unfortunately, while improving the noise immunity of sensor 606 , high impedance electrode 702 in sensor 700 remains unshielded from noise and interference received from directions other than the top of housing 104 .

FIG. 9 shows a cross-sectional view of another alternative capacitive sensor with improved noise immunity according to the present invention. Sensor 900 is suitable for use in detection module 108 and comprises substrate 602 , electrodes 608 and 702 and electrode 902 . Sensor 900 has significantly improved noise immunity compared to sensors 606 and 700 .

Electrode 902 is similar to electrode 702 . However, electrode 902 is formed in substrate 602 such that electrode 608 and electrode 702 are parallel, but electrode 702 is located between electrodes 608 and 902 . Electrodes 608 and 702 collectively define a first parallel plate capacitor in substrate 602, and electrodes 702 and 902 collectively define a second parallel plate capacitor in the substrate.

FIG. 10 shows a schematic diagram of the electrical connections of sensor 900 . In circuit 1000, electrode 702 acts as a sensing electrode sandwiched between drive electrodes 608 and 902, which shields the sensing electrode from noise and interference emanating from above blister card 102 and below housing 104. do.

Electrodes 702 and 902 collectively define capacitor C6, the value of which is determined by the mutual capacitance between these electrodes.

Electrode 902 and lid film 204 collectively define capacitor C 7 , whose capacitance is determined by the physical configuration between electrode 902 and lid film 204 . Like capacitor C 2 , the value of this capacitance is based on the state of sensing region 212 .

Electrode 902 also features capacitor C8, which is similar to capacitor C3 described above.

Electrode 902 also features a substantially fixed electrode capacitance C9.

Operation of sensor 900 is similar to that of sensor 700 . However, the fringe field capacitance of sensor 900 further includes C7 and C8, whose capacitances are determined by the fringe field between electrode 902 and lid film 204 and touch capacitances C3 and C8. As with sensor 700 , the values of fringe field capacitances C 7 and C 8 are based on the state of sensing region 212 , but the value of C 7 can also be affected by user touch on the back of housing 104 .

In some embodiments, additional shielding is provided for sensing electrodes 702 by adding shield lines within substrate 602 surrounding each sensing electrode in its plane.

FIG. 11 shows a plan view of a detection module whose noise immunity is improved by shielding lines formed around each of its sensing electrodes. Detection module 1100 is similar to detection module 108 , but detection module 1100 includes multiple sensors 900 and shielded wires 1102 . FIG. 11 shows a cross-section of detection module 1100 through the plane of electrodes 702 .

Shield line 1102 is a conductive trace formed to substantially completely surround sensing electrode 702 in the plane of the electrode. Shield wire 1102 is electrically grounded as shown.

Due to the shielding provided by electrodes 608 and 902 and shield wire 1102, each sensing electrode 702 is virtually completely shielded from interference from all external noise and EMI sources. Note that the shielded wire 1102 can also be incorporated into the sensors 606 and 700 described above.

Note that in the illustrated example, electrodes 702 are optionally electrically connected together to each column of the 7×4 array of sensors 900 . Each sensor 900, even though electrically connected as shown, employs a matrix addressing scheme in which each row of drive electrodes 608 and 902 is driven either in a time division multiplexed manner or at another drive frequency. can be detected individually. In some embodiments, each of electrodes 702 is electrically connected to electronics module 110 individually.

12A and 12B also show measurements of two individual sensors 900 in response to successive dispensing of two tablets from the blister card 102. FIG. Plots 1200 and 1202 show the capacitance of mutual capacitor C6 against time for the two sensors 900 of detection module 1100 . In plot 1200, tablet 210 has been dispensed over a period of 34 seconds. In plot 1202, tablet 210 has been dispensed over a period of 45 seconds. As plots 1200 and 1202 show, for each sensor the corresponding mutual capacitance changes significantly, allowing detection of each dispensing event. The presence or absence of a tablet within each reservoir 206 can also be determined by the absolute values of these sensing capacitances using pre-calibrated thresholds to indicate the presence or absence of a tablet within each reservoir 206. Please note.

Furthermore, it should be noted that the sensing principle may be changed in the implementation of the means. U.S. Patent Application No. 14/879,874 filed October 9, 2015 (Attorney Docket No. 3005-002US1) and U.S. Patent Application No. 15/170,121 filed June 1, 2006 (Attorney 3005-002US2), electrical impedance tomography (EIT) and electrocardiography were used to image the condition of the blister card (i.e., the pill was dispensed and intact) and to detect dispensing events. The use of volumetric tomography (ECT) has been disclosed and is incorporated herein by reference. In some embodiments, the apparatus and methods described therein enable imaging of the status of OCP cards and are used in the present invention to detect dispensing events.

Further, in some embodiments, predictive models/algorithms based on modeling and experimentation are used to associate specific sensor output signatures with dispensation events. This model is then used to identify tablets during a dispensing event based on sensor output. For example, the output signature of the motion sensor within the detection module allows detection of the position of the dispensing event that has occurred by utilizing the respective predictive model/algorithm.

FIG. 13A shows a schematic diagram of a cross-sectional view of package 100 with an alternative capacitive sensing detection module. Package 100 is shown open, with blister card 102 positioned within the package by receiver 106 (not shown for clarity). The cross section of the package shown in FIG. 13A is taken along line bb in FIG.

The detection module 1300 comprises a sensor board 602 and sensors 1302-1 through 1302-28 (collectively referred to as sensors 1302) arranged on the board in an arrangement matching the arrangement of the tablets 210 on the blister card 102. placed.

Detection module 1300 is similar to detection module 108 described above. However, detection module 1300 is positioned within lid 402 by a receiver (not shown for clarity) similar to receiver 106 described above. Closure of lid 402 brings detection module 1300 into close proximity with blister card 102 , thereby operably coupling each of sensors 1302 to its corresponding tablet 210 .

13B-13C also show cross-sectional views of a portion of detection module 1300 before and after tablet dispensing according to the present invention, respectively.

Each sensor 1302 comprises electrodes 1304 and 1306 and a shield 1308 .

Electrodes 1304 and 1306 are conductive electrodes disposed on the first surface of substrate 602 .

Shield 1308 is a conductive electrode disposed on the second surface of substrate 602 . Shield 1308 is grounded to shield electrodes 1304 and 1306 from interference and electrical noise emanating from the top side of detection module 1300 . Lid film 204 is typically grounded, thereby allowing it to act as a shield from the bottom for electrodes 1304 and 1306 .

When lid 402 is closed and tablet 210 is placed in reservoir 206 , electrodes 1304 and 1306 capacitively couple tablet 210 via fringing field 1310 . As a result, the capacitance between electrodes 1304 and 1306 is based on these fringing fields.

However, when the lid 402 is closed and the reservoir 206 is empty of tablets, the fringing field 1310 is coupled only with the remainder of the reservoir 206 (ie, the deformed forming film 202) and the fringing field 1310 is coupled with the empty reservoir. Due to the different methods of charging, there is a difference in capacitance between electrodes 1304 and 1304 with a filled reservoir.

During operation, detection module 1300 typically interrogates blister card 102 each time lid 402 is closed. The output signal from the detection module is then compared to the most recent previous blister pack status to determine if a tablet has been dispensed and, if so, which tablet. In some embodiments, the presence or absence of a tablet within each reservoir 206 is determined by sensing capacitance during lid closure using pre-calibrated thresholds to indicate the presence or absence of a tablet within each reservoir 206. is determined by the change in the absolute value of

Figures 13D and 13E show cross-sectional views of a portion of yet another capacitive sensing module before and after tablet dispensing according to the present invention, respectively. Detection module 1312 is similar to detection module 1300 described above. However, detection module 1312 is a flexible detection module sized and positioned to contact blister card 102 during operation.

The sensing module 1312 comprises a substrate 1314 and a plurality of capacitive sensors 1302 as described above.

Substrate 1314 is a flexible substrate comprising polyimide. In some embodiments, the substrate 1314 is another material suitable for flexible electronics such as polymers such as poly(methyl acrylate) (PMMA), polyimides, polyurethanes, polyesters, polyetheretherketones (PEEK). formed by Preferably, substrate 1314 is sufficiently flexible to allow forces applied to it to deform forming film 202 and force tablets 210 through lidding film 204 .

When detection module 1312 is in contact with blister card 102 , electrodes 1304 and 1306 capacitively couple tablet 210 via fringing field 1310 . As discussed above, just as the capacitance of each sensor 1302 is based on the presence of a respective tablet 210, the capacitance between electrodes 1304 and 1306 is based on the fringing field 1310. FIG.

The use of flexible substrates also allows the incorporation of detection modules 1312 in or on forming film 202 .

In some embodiments of the invention, detection module 1312 is formed to include an interior volume for containing blister card 102 (ie, detection module has a form similar to a flexible pouch). The interior volume is sized and arranged such that when the blister card 102 is positioned within the pouch, the pouch holds the blister card in close contact with the top (forming film side) and bottom (lid film side). The top and bottom of the pouch also incorporate holes to allow access to the reservoir 206 and dispensing area 212 . Alternatively, as described in some embodiments above, the detection module may comprise a substrate that is flexible enough to partially or completely cover the holes in the top surface. Note that such embodiments of the invention can be implemented using two or more of the different sensing techniques described herein. These embodiments are particularly suitable for use with capacitive sensing and tactile sensing technologies.

Acoustic Sensing FIGS. 14A and 14B show partial cross-sectional views of an alternative acoustic sensing detection module before and after tablet dispensing, respectively, in accordance with the present invention. Detection module 1400 is similar to detection module 108 described above. However, the detection module 1400 comprises a substrate 602 and a plurality of acoustic sensors 1402, each of which detects the presence of a tablet in the blister card reservoir when the detection module is operatively coupled to the blister card from the forming film side. Acts to detect presence.

Each acoustic sensor 1402 comprises a transmitter 1404 and an acoustic detector 1406 .

Transmitter 1404 is a piezoelectric transducer that operates as a conventional acoustic transmitter. Transmitter 1404 is configured to direct acoustic energy (eg, ultrasonic waves, etc.) at tablet 210 when detection module 1400 is aligned with blister card 102 .

Acoustic detector 1406 is a piezoelectric transducer that operates as a conventional acoustic receiver. Acoustic detector 1406 is configured to receive acoustic energy from the direction of tablet 210 when detection module 1400 is aligned with blister card 102 .

In the illustrated example, detection module 1400 is attached to the inner surface of lid 402 of housing 104 . The sensors 1402 are arranged on the substrate 602 such that when the lid 402 is closed, the sensors contact the reservoirs 206 of the blister card 102 so that each sensor is operatively associated with a different reservoir. In some embodiments, sensor 1402 and reservoir 206 are separated by a small air gap when lid 402 is closed. In some embodiments, detection module 1400 is positioned within housing 104 via a receiver, as described above.

Those skilled in the art, upon reading this specification, will recognize that the acoustic impedance of reservoir 206 is different when it is occupied with tablet 210 compared to when the reservoir is empty. In operation, each time the lid 402 is closed, each of the sensors 1402 provides an electrical signal indicating whether its respective reservoir contains a tablet. When a change in acoustic impedance from a previous examination of blister card 102 is sensed, electronics module 110 can determine that a tablet dispensing event has occurred and identify which tablets have been dispensed. In some embodiments, the presence or absence of tablets 210 in each reservoir 206 is determined based on the absolute value of the acoustic signature indicating the presence or absence of tablets in each reservoir 206 using pre-calibrated thresholds.

In some embodiments, detection module 1400 comprises a flexible substrate similar to substrate 1312 described above. In such embodiments, the sensor 1402 is constructed using a flexible piezoelectric film (eg, polyvinylidene fluoride or polyvinylidene difluoride, also known as PVDF) according to conventional flexible electronics manufacturing techniques. formed on a substrate such as As noted above, the use of a flexible substrate in detection module 1400 allows forces applied to the detection module to deform forming film 202 and force tablet 210 through lidding film 204 . It also allows the detection module 1400 to be incorporated within or on the forming film 202 . Further, in some embodiments, the flexible substrate collects mechanical energy (such as that generated while the tablet is being dispensed) using the piezoelectric material of the sensor 1402 and uses it as a sensor module. Allows it to be converted into electrical energy that can be used to power the 1400.

Those skilled in the art will recognize that the detection module 1400 can be sized and positioned for operation from the lidding film side of the blister card 102 without departing from the scope of the present invention.

In some embodiments, transmitterless sound sensing is achieved by placing three or more microphones on the blister card 102 .

FIG. 15 shows a schematic diagram of a perspective view of a blister card with multiple microphones according to another acoustically sensitive embodiment of the present invention. Blister card 1500 is similar to blister card 102 . However, the blister card 1500 comprises six microphones 1502, which are placed on the forming film 202 and distributed over its area.

In operation, each microphone detects the sound of dispensed tablets. Signal processing capabilities included in electronics module 110 and/or mobile device 114 process the output of the microphone to triangulate the sound and identify the location of the particular pill emitting the sound.

In some embodiments, detection module 1500 comprises a flexible substrate that is placed in contact with blister card 102 within housing 104 .

In some embodiments, detection module 1500 comprises a conventional PCB board attached to the inner surface of lid 402 of housing 104 .

In some embodiments, microphone 1502 is placed on a PCB substrate that has holes that allow forces to be applied to reservoir 206 . For example, the PCB substrate may be in the form of a frame that extends along one or more of the inner walls of housing 104 adjacent blister card 102 . In some embodiments, detection module 1500 is mounted therein. In some embodiments, detection module 1500 is disposed therein via a receiver.

Tactile Sensing FIGS. 16A and 16B show cross-sectional views of a portion of a tactile sensing module before and after tablet dispensing according to the present invention, respectively. Detection module 1600 is similar to detection module 108 described above. However, the detection module 1600 comprises a substrate 602 and a plurality of tactile sensors 1602, each of which is positioned within the blister card reservoir when the detection module 1600 is operably coupled to the blister card 102 from its forming film side. to detect the presence of tablets. Sensors 1602 are arranged on substrate 602 in an arrangement that substantially matches the arrangement of the tablets in blister card 102 .

In the illustrated example, detection module 1600 is attached to the inner surface of lid 402 of housing 104 . In some embodiments, detection module 1600 is positioned within housing 104 via a receiver, as described above.

In the illustrated example, each of tactile sensors 1602 comprises electrodes 1604 and 1606 and optional shield 1308 .

Each of the tactile sensors 1602 is a parallel plate capacitor comprising conventional planar electrodes 1604 and 1606 and protrusions 1608 that are protrusions of a soft dielectric material (eg, PMMA, etc.) disposed between and around the electrodes 1604 and 1606. is. The capacitance of sensor 1602 is based on the spacing between its electrodes.

In operation, sensor 1602 contacts reservoir 206 when lid 402 is closed. When a tablet is contained in the reservoir, pressure/force is generated between the sensor 1602 and the reservoir, which is sufficient to push the forming film 202 of the reservoir 206 while pushing the lidding film 204 in the dispensing area 212. The force is not large enough to cause damage. This force causes compression of the material between electrodes 1604 and 1606, creating a relatively large capacitance on sensor 1602. FIG. However, when the sensor contacts a reservoir that does not contain a tablet, little force is generated between the sensor and the reservoir. As a result, the amount of material compression between electrodes 1604 and 1606 is minimal, resulting in a relatively low sensor capacitance.

Therefore, each time lid 402 is closed, electronics module 110 reads the capacitance of each sensor 1602 to determine which tablets have been dispensed from blister card 102 .

In some embodiments, the area between electrodes 1604 and 1606 is occupied by a piezoelectric material that provides an electrical output based on force applied to tactile sensor 1602 . Such embodiments collect energy from the piezoelectric material to detect the state of the blister card 102 and power the detection module 1600 .

In some embodiments, substrate 602 is replaced with a flexible substrate, such as substrate 1314. FIG. Typically, sensor 1602 is formed within such a substrate using flexible electronics manufacturing techniques. In such embodiments, detection module 1600 is sufficiently flexible to allow forces applied thereto to deform forming film 202 and force tablet 210 through lid film 204 . Such an embodiment allows the detection module 1600 to be incorporated into or onto the forming film of the blister card.

In some embodiments, the detection module 1600 is operably coupled with the blister card from the lidding film side. Sensors 1602 are positioned between dispensing areas 212 to act to sense the force exerted on blister card 104 during each dispensing operation.

It will be apparent to those skilled in the art from reading this specification that there are various methods for implementing tactile sensing. For example, sensor 1602 can be implemented based on any principle that produces an electrical or other detectable signal as a result of tactile stimulation. A broader interpretation of tactile sensing includes measuring deformation of the surface of the blister card 102 or housing 104, for example by utilizing strain sensors on/in a flexible substrate printed directly on that surface. .

Optical Sensing FIGS. 17A and 17B show cross-sectional views of a portion of an optically sensitive detection module before and after tablet administration, respectively, according to the present invention. Detection module 1700 is similar to detection module 108 described above. However, the detection module 1700 comprises a substrate 602 and a plurality of optical sensors 1702, each of which detects a tablet in the reservoir of the blister card when the detection module is operatively coupled with the blister card from the forming film side. operates to detect the presence of In the illustrated example, detection module 1700 is positioned on the inner surface of lid 402 .

Each sensor 1702 comprises a photodetector 1704 that operates to detect light 1706 . A plurality of photodetectors are arranged on the substrate 602 in an arrangement that substantially matches the arrangement of the tablets 210 on the blister card 102 .

In the illustrated example, light 1706 is ambient light emanating from outside housing 104 . In some embodiments, light 1706 is provided by a light source contained within package 100 and typically mounted below detection module 108 . Light sources according to the present invention include, but are not limited to, diffuse light sources, arrays of light emitters (eg, LEDs, lasers, etc.) aligned with photodetector 1704, and the like.

In operation, when a tablet 210 is dispensed, the opaque lidding film 204 is fractured, allowing light to pass through the detection area 212 at the tablet site and reach the photodetector 1704 . As a result, light detection by the photodetector signals that a tablet has been dispensed from the respective sensor location. In some embodiments, the condition of blister card 102 is checked each time lid 402 is closed.

Although the detection module 1700 is located on the top side (i.e., the forming film side) of the blister card 102 in the illustrated example, a reading of this specification indicates that the optical signal 1706 is directed through the blister card from the top side to the bottom side. It will be clear to those skilled in the art how to make and use alternative embodiments in which the detection module 1700 is positioned on the bottom surface (ie, lidding film side) of the blister card 102 so that it passes through. In some of these embodiments, the state of blister card 102 is determined when lid 402 is opened.

In some embodiments, the substrate of detection module 1700 is formed from a transparent flexible substrate comprising a substantially transparent polymer such as PMMA, polyimide, polyurethane, polyester, PEEK. In such embodiments, detection module 1700 may be placed in contact with blister card 102 . Preferably, in such embodiments, the substrate is made of a material suitable for forming a flexible electronic device, and the force applied is sufficient to deform the forming film 202 and force the tablet through the lidding film 204 . flexibility. The use of flexible substrates also allows the incorporation of detection module 1700 in or on forming film 202 .

In some embodiments, the detection module 1700 includes a planar lightwave circuit whose surface waveguides carry light generated by light sources remote from the sensors 1702 to each sensor, collect light transmitted through the sensor area, and transmit it to a remote detector. (PLC). Preferably, in such embodiments, the PLC is substantially parallel to the blister card 102, and light enters and exits the sensor area from the PLC through vertical grating couplers.

Figures 18A and 18B show cross-sectional views of a portion of an optically sensitive detection module before and after tablet administration, respectively, according to the present invention. Detection module 1800 is similar to detection module 1700 described above. However, detection module 1800 is located on the inner bottom surface of housing 104 and operates in reflective mode. The detection module 1800 comprises a plurality of sensors 1802 arranged to match the placement of the tablets within the blister card 104 .

Each sensor 1802 comprises a photodiode 1704 sized and positioned to detect light reflected from the lidding film 204 only when the respective distribution area 212 is intact. In the illustrated example, sensor 1802 detects ambient light. In some embodiments, each of sensors 1802 further comprises a light source that illuminates distribution area 212 . In some embodiments, a single light source is included in detection module 1800 to illuminate the entire lidding film with diffuse light.

Thermal Sensing As mentioned briefly above, thermal sensing can also be used to detect tablet dispensing events in accordance with the present invention. By monitoring heat transfer across each dispensing area 212 of the blister card 102, lidding film failure in the dispensing area can be detected. In some embodiments, a first resistor located on the lidding film 204 on one side of the distribution area 212 is driven to generate heat in the lidding film. Heat is then detected by a temperature sensor located on the lidding film 204 on the other side of the dispensing area. If the lidding film is intact in the dispensing area when the temperature of the heater increases by the increment, the temperature increase is detected by the temperature sensor. However, if the lidding film is damaged, heat conduction through the distribution area 212 is impeded and the temperature rise detected at the temperature sensor is significantly reduced.

It should be noted that the concepts of the present invention are applicable to smart packaging suitable for monitoring the condition of multiple blister packs.

Figure 19 shows a schematic diagram of a perspective view of a multi-blister card package according to an alternative embodiment of the present invention. Package 1900 is a metapackage that operates to monitor the status of multiple blister cards 102, each of which can have different prescriptions or multiple copies of the same prescription.

Package 1900 includes housing 1902, electronics module 110, receivers 1904-1 through 1904-N, and detection modules 1906-1 through 1906-N. Package 1900 is sized and configured to receive and position blister cards 102-1 through 102-N.

Housing 1902 is similar to housing 104 . However, housing 1902 is sized and configured to accommodate multiple receivers, detection modules, and blister cards.

Each of receivers 1904-1 through 1904-N (collectively referred to as receivers 1904) is similar to receiver 106; However, each receiver 1904 includes a hinge that allows it to be rotated to expose a different blister card.

Each of detection modules 1906-1 through 1906-N (collectively detection modules 1906) is similar to detection module . However, each detection module 1906 is sized and positioned to monitor the status of a different blister card. In some embodiments, detection module 108 uses multiple sensor technologies.

Each of detection modules 1906 is electrically coupled to electronics module 110 as described above to enable operation of package 408 as described above and with respect to package 100 .

The present disclosure teaches only a few examples of embodiments of the invention, and many variations of the invention can be readily devised by those of ordinary skill in the art upon reading this disclosure. The scope should be determined by the following claims.

100 package

102 blister card

104 housing

106 receiver

108 detection module

110 electronics module

112 output signal

114 mobile device

116 input signal

202 molding film

204 lid film

206 reservoir

208 cavity

210 tablet

212 distribution area

402 lid

602 substrate

604 hole

606 sensor

608,702,902 electrodes

804 electoronic signals

1102 Shielded wire

1404 acoustic transmitter

1406 acoustic receiver

1602 tactile sensor

1704 photodetector

1706 optical signal

1906 detection module

C1,C2,C6 Capacitor