Patent Application
20220287915
The present invention relates to containers for holding medications, with marked sections for each day or dose; and in particular to smart pill containers that wirelessly communicate with remote servers/computers to track a patient's adherence to a dosing schedule.
Medication non-adherence is a problem that has been said to cost the U.S. healthcare system over 125,000 lives, and $300 billion each year. Containers comprising pill organizers have been shown to be an effective way to help people who have multiple medications organize their medications; however, errors often occur when people fill their own pillboxes. Most pharmacies will not fill pill organizers due to the lack of a scalable way of doing so.
Remote monitoring of medications dosing has also been shown to be an effective way to improve medication adherence. While current designs for remote sensing of medication boxes exist, there is a need within the pharmacy industry for an automated-robotic system to fill smart-wireless pillboxes.
Other issues with existing designs for wireless pillboxes include individual units that are too small to hold the right quantity of pills; or that are too large to be fillable by a robotic system; or that are connected in a way that makes them difficult or impossible to be filled in an automated manner.
Additionally, mechanical or light-based sensing methods do not reliably detect the removal of a dose under a range of conditions. Other sensor configurations consume a large amount of battery life, making them impractical.
Described herein is a smart, wireless pillbox, that can be easily automatedly, robotically filled and labeled at the pharmacy, customizable to each patient's medication intake, and which requires a significantly lower amount of battery power than the prior art to detect when the doses are administered.
The present invention comprises a smart pill organizer storing a plurality of a patient's medication dose units; method of using in a networked system for monitoring dose adherence by a remote computer; a computer program product; and a method of forming and filling the dose units using a plastic sheet in a robotic machine that is filled with the medications and then cut into the individual dose units.
The smart pill organizer device may also be pre-programmed with scheduled doses. If a dose is taken within a pre-programmed dose interval, then the dose will be automatically recorded and a reminder will not occur. If the dose is not taken, then the organizer device will emit a reminder; or if the wrong dose is taken, an alert is sent. Optionally, a mobile application of the present invention that is installed on a user's electronic computing device (e.g. smartphone, tablet, etc.) may also emit a series of reminders if a dose is not registered by the preprogrammed time. Additionally, a software application of the present invention that is running, e.g. on a system server, may send a reminder if a dose is not recorded, by the pre-programmed time, or the wrong dose is taken.
Various embodiments of the present disclosure comprise a smart pill organizer device (or smart packaging), comprising a container with a sheet of replaceable dose units able to be filled by a robotic system, and tagged with a patient specific unique identifier. The bottom of the container comprises components of an electronic computing system that enable the device to communicate wirelessly with various remote and local (e.g. a patient's smartphone) to determine if a patient is taking their medication on time; to send reminders to take a dose; to alert the patient and third party computers when doses are missed; and to automatedly order prescription refills as needed.
In an embodiment, the smart pill organizer device further comprises: a printed circuit board; electromagnetic sensors, e.g. beneath each dose unit able to detect when a dose is taken; a wireless transmitter; a battery; a memory; a microprocessor; and a speaker-buzzer.
In an embodiment, the smart pill organizer device further comprises: a) a lid covering the top surface of the device, which may comprise a graphical display and/or a camera; b) a plurality of removable dose units, each unit filled with one or more medications, and sealed closed on the top with: a paper or foil attached to the four edges (e.g. via cold press techniques well known in the art), or a cap that can be popped on/off, or a pivotable cap that is hinged at one edge to keep the lid attached; c) a removable carrier tray, with a plurality of holes that are sized to hold the dose units in a manner that the top of the dose unit is above the tray and the bottom of the dose unit is beneath the tray and the tray resides on top of the container; and d) a bottom unit comprising: a container with a plurality of receptacles of concave cavities for holding the removable dose units; an exterior case sized to fit the tray; and a button that is depressed by a user when a new carrier tray has been placed into the exterior case of the smart pill organizer, and/or to reorder a new tray of dose units (i.e. a prescription refill).
The smart pill organizer device can be a standalone product that communicates to a patient when to take a dose (e.g. via a speaker and/or display on the device). In a preferred embodiment, the smart pill organizer device is part of a networked system of electronic computing devices (e.g. patient's smartphone with a mobile application, pharmacy computer, doctor's office computer, and remote servers with patient records on a database). The networked system communicates with the smart pillbox device via a wireless network, which may include a voice activated hub (e.g. Amazon Echo®, Google® Assistant, or the like) that is linked to the pillbox device.
The various embodiments of the present disclosure further comprise; methods of automatedly tagging the dose units with a patient's unique identifier; manufacturing the dose units as a tagged sheet in a robotic filler, and cutting the sheet into individual units; non-transitory computer readable storage media comprising instructions for a processor (e.g. patient's mobile application; and system server software); methods of automated refilling and shipping trays of prescriptions; the networked computer system for patient monitoring and communication; etc.
In an embodiment, the pillbox may further comprise: at least one electrical and/or mechanical component for verifying the identity of a user before unlocking the pillbox container, comprising one or more of: a fingerprint scanner, a passcode reader, a two-factor authentication reader, a voice recognition device.
In an embodiment, the smart pill organizer device further comprises a lid, and comprises a touchscreen and a camera that are embedded into the lid or into other parts of the device, e.g. the removable carrier tray or the bottom unit, and enabled for conducting wireless communications with a remote healthcare provider or a caretaker.
These and other aspects, objects, features and advantages of the example embodiments will become apparent to those having ordinary skill in the art upon consideration of the following detailed description of illustrated example embodiments.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate certain aspects of the instant invention and, together with the description, serve to explain, without limitation, the principles of the invention.
Smart device: the pill organizer device 90 of the present invention is a smart, wireless device that is able to connect to remote computers and a mobile application of the present invention to transmit and receive information about whether and when a patient has taken a dose of medication, per the networked system of
In an embodiment, as illustrated in
In the plurality of dose units 102 comprising a lid 118 covering a bottom container 119, each unit 120 is filled with one or more medications, and sealed closed. As illustrated in
In one exemplary embodiment, device 90 includes a total of at least 31 dose units 102 fitted into 31 receptacles 108, and that are arranged in a grid of 7 by 4 or 5 dose units (see
Cover (Aftermarket Version): To enable a version of the smart pill organizer that can be useful absent a pharmacy-enabled workflow, an optional cover may be placed on the dose pods to keep the pills inside of them. This mechanism may be used in lieu of a paper or plastic label that is affixed to the dose unit. In an ideal embodiment this material is silicone. In another embodiment the cover may have scores in the top, enabling pieces of the cover to be temporarily separated to place one or more pills into the dose unit without removing the cover.
Dimensions: The dimension range of the dose unit 102 is important, as there is a relatively narrow range that must be met to ensure that the dose units are large enough to hold a sufficient quantity of medications, while also forming a grid that is not too large to be filled by a robotic filling system, such as the Synmed™ system, or another robotic filling system made by Omnicell™. Exemplary ranges of dimensions of the dose unit 102 are: 1.4 inches wide×1.1 inches tall×1 inch deep.
In an exemplary embodiment, dose unit 102 has at least 1 tapered location on the exterior sidewall of the dose unit, and preferably two, the first tapered region catching the carrier tray holder (
In an alternative embodiment, the bottom of the dose unit 102 may rest on the bottom of the receptacles 108, or on a protrusion pointing upward from the bottom of the receptacle 108, e.g. atop a sensor 124 to detect movement or change in weight of the dose unit, thus indicating a dose being taken.
Material: The material of the dose unit lid 118 and/or bottom container 119 is ideally a food grade or medication-grade plastic material, such as a polypropylene. In an ideal embodiment the material may be tinted amber color such as to prevent the transmission of light that could degrade the medication compounds inside the container. The material may also be transparent or an opaque color, such as opaque white.
Dose Unit Sheet, and Separation of Sheet: The dose units may originally be produced in a singular plastic sheet, with individual dose units being separated by perforated or scored marks between them. Such perforations or scores may be made by the mold or by a secondary process that is performed after the production of the dose unit tray 104. In an alternative embodiment the dose units may be held together by plastic rods that can be snapped off of the dose unit.
The dose units 120 may be separated either during or after filling. In either case, the dose units are likely to be placed in a template holder during the filling process. A printed label (e.g. medication, dose, patient, etc.) may be applied to a sheet of dose units after the dose units are filled with their respective medications. This printed label is likely to have an adhesive backing on one side. The other side of the label sheet is likely to accept a printable coating. In an ideal embodiment the label sheet has at least one dimension that is or equal to a standardized printing dimension, such as 8.5″×11″ or 11″×17″, such that the label can be easily trimmed or folded after printing.
The removable carrier tray 104 is shaped to fit the top of container 106 (e.g. tray 104 is thin rectangular shaped in the exemplified embodiment of
The carrier tray 104 is made from a thin material, ideally between 0-20 mm in thickness, and most ideally between 1-10 mm in thickness. The carrier tray can be made of any rigid or semi-rigid material, including plastic, cardboard or metal. In an ideal embodiment the carrier tray is made of an injection molded or blow-molded piece of continuous plastic. The carrier tray can hold a plurality of dose units, most ideally in a multiple of 7, 28, 30 or 31.
The smart pillbox organizer bottom unit 110 is comprised of: a container 106 comprising a plurality of receptacles or concave cavities 108, for insertion of the removable dose units 102; an exterior case 110 sized to fit tray 106 (and optionally with a lid—e.g. see
Organizer 110 further comprises the following electrical components, as illustrated in
In an embodiment, an electric circuit is printed or overlaid over each dose, at least a portion of the circuit being designed to broken when the pills interior to the dose unit are removed from the dose unit, and where this disruption in the circuit or antenna is detected, at least in part, by the microcontroller. Additionally, or in another embodiment, the circuit is printed to have different combinations of resistance or capacitance between doses, the removal of a dose being measured by detecting the change in the circuit's resistance or capacitance.
In one exemplary embodiment, organizer 110 further comprises: a printed circuit board 122 or flexible circuit that connects components: a first series of sensors 124, one beneath each dose unit 102, each sensor is activated and deactivated by removing a dose unit 102 from the container 106; a second sensor 125, which is activated by the opening and closing of the lid; an accelerometer, which detects motion of the device 90; a gyroscope 105, which detects orientation towards the gravity vector; a button 112, which can be pressed by the users upon the device refill to reset the sensors and PCB; a wireless radio(s) 123, capable of transmitting a signal to a cellular network and/or to a nearby WiFi router or remote computer; an energy storage device, e.g. a replaceable battery 117, ideally of lithium or alkaline chemistry; a local computer memory 114; and at least one processor/microprocessor 113.
Wireless radio: While the wireless radio may be of any spectrum, an ideal embodiment it is a low-power cellular radio, such as a NbIoT or LTE-M.
In an alternative embodiment, it may be a short-range wireless radio, such as a radio that operates at the 802.11 standard, or as originally defined by the IEEE 802.15.1 standard. In another ideal embodiment the frequency of the radio is between 2400 and 2489 MHz or at the 2.4 GHz frequency range.
Microcontroller and Operating Modes: The microcontroller can be programmed to include a variable for the mode that the smart pill organizer 90 is operating in, the mode being tied to the configuration of the dose units. For example, a weekly mode could be set to expect 7×4 or 7×3 doses, whereby a monthly mode could be set to include 28, 30 or 31 doses, depending upon the month. In this sense, the smart pill organizer is designed to store information on the device including a) whether it is operating on a weekly or monthly basis b) the number of doses per day c) the starting day or date associated with at least one of the dose unit receptacles d) a time of day associated with each mode.
Color Touchscreen Display: Optionally, the smart pill organizer may include a color touchscreen display 107, the display showing per Table 1:
Video Camera: Optionally, the smart pill organizer may also include a video camera 98 embedded in container 110 (e.g. lid) or connected to the PCB 122 (e.g. via a USB cable to a smartphone 9 of
Locking Mechanism and Refills: The smart pillbox may further comprise a lock on the exterior container with the lid 110 that requires verifying the identity of the user before it can be opened and the dose accessed or a refill ordered. By way of non-limiting examples, the container with the lid 110 may further comprise one or more electrical and/or mechanical components comprising: a fingerprint scanner, a passcode, a two-factor authentication, or a voice recognition. Preference is for a biometric verification that is performed locally on the device 90 (e.g. fingerprint scan or voice recognition). In an embodiment, the pillbox 90 is unlocked in response to a combination of a user action and an identification verification. User action comprises, e.g.: pressing a button on the container (e.g. button 112), touching a fingerprint scanner, or issuing a voice command, or touching a capacitance sensor on the pillbox itself. In another embodiment, the user identification must be verified before a refill is ordered, e.g. via a voice-initiated refill that can only be ordered after verifying identification using one of the listed methods.
An RFID tag, NFC tag, Bluetooth beacon or other unique identifier 97 may be attached to each dose sheet or carrier tray 104. This unique identifier 97 may be read by an internal reader/sensor 96 within or accessible to the smart pill organizer when a new set of dose units 102 is placed into the smart pill organizer 90. When this is detected, the smart pill organizer microprocessor may: a) reset the dosing schedule; and/or, b) lookup the corresponding dose units and schedule that was included. This information is stored on the memory of the organizer 90, and/or is wirelessly accessible via the network connecting with one or more of: the user's, and/or caregiver's, and/or patient record on a pharmacy computer or on a remote server of the present invention (e.g. see
In an embodiment, one or more unique wireless tags 97 are attached to the sheet of dose units, each tag having a unique identifier and corresponding to a unique dose unit, the unique identifier being correlated to a unique combination of medications or pills, a day, and a scheduled dose time window, whether in local storage on the device or in the cloud-based dose management system, and wherein the smart pill organizer device may also include a wireless reader/sensor 96 for such tags. For example, an NFC or RFID tag 97 covers each dose unit so the system can detect removal of each dose unit.
In another embodiment, the wireless tag 97 has a unique ID that correlates to a unique medication or combination of medications and a unique day, dose time, and dose window either in local storage on the device or in the cloud-based dose management system.
In order to facilitate detection of an electromagnetic sensor, each dose unit 102 may be doped with, or be attached to an additional material with readily detectable electromagnetic properties. For example, in one embodiment a portion of the plastic material could be doped with a magnetic or conductive material, to result in a magnetic or electromagnetic piece of plastic. In another embodiment a magnet or metallic circle, fragment or strip could be attached to the bottom of the dose unit, including by using an adhesive. Such a material would not need to be large but would ideally be large enough to manipulate with a finger, (e.g. between 1 and 90 square millimeters). In an alternative embodiment an RFID or NFC tag 97 or sticker could be placed on the bottle of each dose unit—this would have the additional benefit of detecting the removable of an individually-labeled dose.
Prior art wireless pill organizers disclose the use of mechanical switches to measure the removal of dose units. In contrast, the present invention teaches the use of various electromagnetic sensors (see
In
The dose units are robotically filled and placed into the box using the following method as listed in Table 2. In an embodiment, at least one sensor of
The smart pill organizer device 90 of the present invention may be used as a stand-alone device for a user to receive verbal messages for the device's speaker to remind them to take their medication on time. Or, preferably, the device 90 is used in conjunction with the networked system of
The smart pill organizer device 90 is able to be pre-programmed with scheduled doses. If a dose is taken within a pre-programmed dose interval, then the dose will be automatically recorded and a reminder will not occur. If the dose is not taken, then the organizer device will emit a reminder. Optionally, a mobile application of the present invention that is installed on a user's electronic computing device (e.g. smartphone, tablet, etc.) may also emit a series of reminders if a dose is not registered by the preprogrammed time. Additionally, a software application of the present invention that is running on a system server may send a reminder if a dose is not recorded by the pre-programmed time.
Messaging may also be delivered depending upon the last time the data from the smart pill organizer device has been synced to the internet. For example, if the last time the user connected to the internet was 48 hours ago, then the user may receive a message asking them to connect to the internet, where if they are currently connected to the internet then the message may remind them to take their medication.
An important part of this application is the connection of data. In the preferred embodiment a remote caregiver, such as a pharmacist, has access to the data through a clinical support platform, the clinical support platform providing: a) a way to view medication adherence data; and b) (preferably) a way to communicate with the patient (e.g. electronic messaging, email, etc.).
Automated Prescription Refill: In another embodiment, an activation of the switch or button (
The example systems, methods, and acts described in the embodiments presented previously are illustrative, and, in alternative embodiments, certain acts can be performed in a different order, in parallel with one another, omitted entirely, and/or combined between different example embodiments, and/or certain additional acts can be performed, without departing from the scope and spirit of various embodiments. Accordingly, such alternative embodiments are included in the inventions described herein.
Although specific embodiments have been described above in detail, the description is merely for purposes of illustration. It should be appreciated, therefore, that many aspects described above are not intended as required or essential elements unless explicitly stated otherwise. Modifications of, and equivalent components or acts corresponding to, the disclosed aspects of the example embodiments, in addition to those described above, can be made by a person of ordinary skill in the art, having the benefit of the present disclosure, without departing from the spirit and scope of embodiments defined in the following claims, the scope of which is to be accorded the broadest interpretation so as to encompass such modifications and equivalent structures.
The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. The transitional phrase “consisting of” excludes any element, step, or ingredient not specified in the claim. The transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel characteristic(s)” of the claimed invention.
Or, the technology illustratively described herein suitably may be practiced in the absence of any element(s) not specifically disclosed herein. Thus, for example, in each instance herein any of the terms “comprising,” “consisting essentially of,” and “consisting of” may be replaced with either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and use of such terms and expressions do not exclude any equivalents of the features shown and described or portions thereof, and various modifications are possible within the scope of the technology claimed. The term “a” or “an” can refer to one of or a plurality of the elements it modifies (e.g., “a reagent” can mean one or more reagents) unless it is contextually clear either one of the elements or more than one of the elements is described. The term “about” as used herein refers to a value within 10% of the underlying parameter (i.e., plus or minus 5%), and use of the term “about” at the beginning of a string of values modifies each of the values (i.e., “about 1, 2 and 3” refers to about 1, about 2 and about 3). In a preferred embodiment, about refers to plus or minus up to 25% of the stated value. Further, when a listing of values is described herein (e.g., about 50%, 60%, 70%, 80%, 85% or 86%) the listing includes all intermediate and fractional values thereof (e.g., 54%, 85.4%). Thus, it should be understood that although the present technology has been specifically disclosed by representative embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and such modifications and variations are considered within the scope of this technology.
As used herein, the term “substantially” refers to approximately the same shape as stated.
While several embodiments of the disclosure have been described, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of embodiments.
Trademarks: the product names used in this document are for identification purposes only; and are the property of their respective owners.
This is a § 371 National Stage application of International Patent Application PCT/US2020/043642 filed on Jul. 25, 2020, which claims the benefit of U.S. provisional Ser. No. 62/878,952 filed on Jul. 26, 2019, the entire contents of which are hereby incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US20/43642 | 7/25/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62878952 | Jul 2019 | US |
