There currently exists a severe drug overdose epidemic in the United States, which according to the CDC resulted in the death of more than 70,000 people in 2017. This is a complex epidemic largely driven by heroin and fentanyl. However, controlled prescription medications are often primary or secondary contributors to these overdose events. There were 15.7 billion controlled medication (CM) dose units (pills) and a total of 415.6 million controlled medication prescriptions written in the US in 2016. That represents a 200% increase since 2000.
There is abundant literature documenting the high-risk for controlled medication overuse, misuse, diversion, addiction, and overdose deaths. There are several state and national lawsuits against pharmaceutical manufacturers and distributors alleging that the extreme risk of addiction and misuse associated with controlled medications was well known and that these medications were marketed aggressively thereby contributing to addiction rates and deaths. The CDC has updated its restrictive 2016 guidelines to prescribers both to address the significant dangers associates with the prescribing and managing of controlled medications and in recognition of the fact that many patients continue to need these controlled medications on a daily basis to function and manage chronic daily disease. Therefore, there exists significant projected and ongoing needs to utilize controlled medications in medical practice and significant risks associated with their use.
Consequently, prescribers and patients are caught in this real high-risk situation. While prescribing guidelines exist, and there are some complex and expensive safe dispensing options, there are currently no effective or practical tools available to prescribers and patients that directly address dosing safety.
Currently, medications are distributed in basic plastic pill containers. The patient or other person capable of unscrewing the cap has access to the entire quantity of pills at any given time. This access recurs with every dose and every time the bottle is opened (30-120×/month). This repeated exposure dramatically increases risk for loss, overuse, misuse, diversion, poisoning, and overdose. The continued use of the standard childproof pill bottle first invented in the 1960's for all medication dispensing including high-risk and controlled medications represents a severe safety flaw that puts many thousands of prescription medication users at risk.
In its most basic aspects, the present disclosure provides a simple, safe, and inexpensive smart pill bottle, sized and configured for timed, single-dose dispensing of a medication, such as a controlled class II-IV medication or a high-risk medication as well as non-controlled medications, particularly when timed dosage/medication delivery is of importance.
The primary medication classes suitable for dispensing by the devices and systems of the present disclosure include the controlled classes II-IV. This includes, but is not limited to, opiates, such as morphine, oxycodone, hydromorphone, hydrocodone, and other opiate derivatives; benzodiazepines, such as lorazepam, diazepam, clonazepam, alprazolam, and other benzodiazepine derivatives; amphetamines, such as Adderall, Ritalin, methamphetamine, and other amphetamine derivatives; as well as Suboxone (buprenorphine), pregabalin, and associated atypicals. Although one focus of the present disclosure is to address controlled medication risk, the devices and systems of the present disclosure provide an effective tool for dispensing in a time-controlled manner any medication requiring carefully monitored dosing, including non-controlled/non-scheduled medications.
Further, prescriptions for all medications including controlled medications listed above dictate the periodicity of dosing (i.e. “3 times per day”, “at bedtime”, or “every 6 hours”), the duration of the prescription (1 week, 1 month, etc.) and the total number of pills prescribed. The pharmacist or other qualified staff typically fills the complete quantity of medication and prints the guidelines on the bottle. In the case of controlled medications, this may equate to 10-120 pills/caps per month.
The present disclosure is directed to a device that is a sturdy and reusable pill dispenser that can be programmed, based on prescribed dosing parameters, to release a single unit dose in a scheduled fashion. Unlike currently existing “safe-dose” options, the present invention is less complex (i.e., simple), hand-held, reliable, mass-producible, and lower cost. The present disclosure provides an easy and effective tool for patients, pharmacists, and prescribers to assist in the continuous safe and scheduled dosing of controlled and high-risk medications as well as non-controlled medications, particularly when timing of dosage delivery is of importance and/or additional doses may lead to adverse effects. The present disclosure is also related to associated systems and methods.
According to the design features of the devices of the present disclosure, the patients and family members do not have easy access or exposure to large pill quantities, but rather only to a single dose that is dispensed according to a predetermined time schedule. For example, when programmed, the device allows for the dispensing or release of a single dose (i.e. one or more pills) at a predetermined time or interval. The device can include a clock or timer that counts down to a predetermined dispensing time (e.g., release of the dose when the timer reaches “0:00”), thus allowing for the dosing as scheduled. The device may also include an override feature that allows a person, for instance an authorized person, to modify, erase, or otherwise reprogram the device for future release of medication.
The devices, systems and methods of the present disclosure equip the prescriber with a degree of certainty that medication is being properly dispensed and overuse risk is thus minimized. Further, the devices and systems of the present disclosure equip the pharmacist with a tool to safely dispense large quantities of pills. Also, the devices and systems of the present disclosure equip the patient with significantly improved medication dispensing and safety, while concomitantly not exposing the patient and other people to large pill counts. A benefit of the secure and controlled release of the medication is that it equips the authorities with a tool to reduce diversion and illegal sale of controlled medications. Most importantly, the devices and systems of the present disclosure have the potential to prevent tens of thousands of people from being accidentally poisoned and saving people from unintentional and intentional overdose events.
Other objects, advantages and novel features of the present disclosure will become apparent from the following detailed description when considered in conjunction with the accompanying drawings, all of which are contemplated to be part of the inventive disclosure.
Features and advantages of the present disclosure will become apparent to those skilled in the art from the following description with reference to the drawings, in which:
For simplicity and illustrative purposes, the principles of the present disclosure are described by referring mainly to various exemplary embodiments thereof. Although the preferred embodiments are particularly disclosed herein, one of ordinary skill in the art will readily recognize that the same principles are equally applicable to, and can be implemented in other systems, and that any such variation would be within such modifications that do not part from the true spirit and scope of the present disclosure. Before explaining the disclosed embodiments in detail, it is to be understood that the disclosure is not limited in its application to the details of any particular arrangement shown, since the teachings are capable of other embodiments. The terminology used herein is for the purpose of description and not of limitation.
The devices and systems of the present disclosure include a novel pill bottle assembly 10 including medication dispensing mechanisms that comprise several components. In one embodiment, the components interlock to make a full assembly. Exemplary embodiments are shown in
The illustrated housing 20 is preferably a cylindrical and/or smooth sheath which may be made of the same durable material (e.g. aluminum, stainless steel, plastic, PVC, etc.) as the base 30. The housing 20 is preferably resistant to destruction or damage, for instance through mechanical, chemical, heating, melting, or other means. In one embodiment, the housing 20 is, to a degree, indestructible, so as to deter and make difficult, access to the medication inside, thereby discouraging misuse or abuse of the medication. The housing 20 may have a locking mechanism, for instance either a mechanical, electronic, magnetic, Bluetooth or digital lock (or any combination of common locking mechanisms) that locks the housing 20 securely to the base 30, when they are provided as separate components. The lock permits only the pharmacist or other authorized user the ability to lock and unlock the housing 20 and access the inner components including the disk stack 40 and its compartments and the related mechanisms inside the assembly 10.
The housing 20 slides over all the body components, preferably in a seamless fashion. When “locked”, the housing 20 cannot be unscrewed or otherwise removed and there is no access to the medications inside the assembly 10 (aside from the medication dispenser 60). The seamless nature of the housing 20 and its durable construction make it secure and relatively tamper proof. Alternatively, the top 50 of the device, which preferably includes a twist cap mechanism, can be removable for placing the pills and associated containers (e.g., disk stack 40) within the housing 20 (
As shown in
The device and system of the present disclosure may optionally include pill disks 80 with unit reservoirs of varying sizes and shapes that can accommodate the wide variety of pill and capsule shapes and sizes, as well as combinations of pills, capsules, etc. For instance, one form is disk 100 and another form of disk 110, any of a variety of suitable disks 80, 100 or 110 may be suitable. Each disk 80 may hold a varied number of pills, capsules, gels, doses, etc. depending on dose, size, and shape. Disks 80 are stacked vertically on the shaft 70. In one embodiment, a rotation of the top 50 rotates the shaft 70. In one embodiment, only the top disk (the uppermost disk) is mechanically and/or fixedly connected to the shaft 70 by a shaft connector 140. The shaft connecter 140 may be fixedly connected to the shall 70 and may include protrusions, teeth, tabs, or other engagement members which engage the uppermost disk. The disks underneath (the lower disks) are stabilized in position relative to the base 30 by the shaft 70 and allowed to rotate about the axis formed by the shaft 70. This allows for easy transport of the disk stack 40.
Referring to
The illustrated pill stack delivery system 10 is configured to deliver one or more pills into the medication dispenser 60 in a consistent manner with each suitable rotation of the top 50. The rotatable top 50 may be locked from rotation until the pre-programmed timing mechanism releases it. In one embodiment, the rotatable top 50 can only be twisted once a timer lock is disengaged. In a preferred embodiment, the rotatable top 50 includes a safety features such that only specific movements allow rotation of the top 50, for instance, depressing the top 50 relative to the assembly 10 and rotating the top 50 only after it has been depressed.
In one embodiment, an assembly 10 is provided with a plurality of stacked medication dose storage disks 40, each disk 80 having a generally flat circular shape, each disk 80 having a plurality of defined storage compartments (as shown in the drawings of the disks 100, 110 and 120) for holding individual doses of medication, each storage compartment having two side walls, the side walls extending radially outward from near the middle of each circular disk 80. One or more of the stackable medication dose storage disks 80 has a gap configured to allow a pill to pass from a storage disk above it (as shown in the drawings of the disks 100, 110 and 120, and, for instance,
In one embodiment, one or a plurality of the medication dose storage disks 80 is provided with a top wall for each storage compartment, the top wall being provided above the compartment.
In one embodiment, a flat planar separator 260 is provided adjacent one or more of the medication dose storage disks 80. The separator 260 may have a gap configured to allow a pill to fall through said gap when a storage compartment on an adjacent storage disk 80 is aligned with the gap.
In one embodiment, a plurality of flat planar separators 260 are provided one separator 260 being provided between adjacent storage disks 80 so as to separate individual doses of medications from the doses in the adjacent storage disks 80. Each separator 260 may have a gap configured to allow a pill to fall through said gap when a storage compartment on an adjacent storage disk 80 is aligned with the gap.
In one embodiment, a shaft 70 extends through the central axis of the plurality of stacked medication dose storage disks 40 such that a plurality of stacked medication dose storage disks 40 can rotate about the shaft. In particular, a set of the plurality of stacked medication dose storage disks 40 can rotate about the shaft. In one embodiment, the top most medication dose storage disk 80 is fixedly attached to the shaft 70 or the rotatable top 50, while the remaining medication dose storage disks 80 are allowed to rotate about the shaft 70.
Referring to
Each of the upper engagement mechanism 180 and the lower engagement mechanism 170 may be selected from the group consisting of an edge, bevel, tab, block and protrusion, tooth, teeth, magnet, electronically controlled magnet, or other similar feature.
In a preferred embodiment, the device 10 includes a plurality of medication dose storage disks 40, each having an upper engagement mechanism 180 and a lower engagement mechanism 170.
The device 10 may further include a rotatably attached top 50, an outer shell or housing 20 and a base 30. The housing 29 is preferably configured to securely engage the top 50 and the base 30 and thereby provide a secure container for the medication to be stored and dispensed therefrom.
In a preferred embodiment, housing 20 and the base 30 are formed as a single component.
The device 10 may also include a lock mechanism. The lock mechanism configured to only allow release of a medication dose from the device after a predetermined period of time has passed.
The device 10 may also include a dispenser 60 in the base 30. The dispenser may be provided with an opening mechanism. The dispenser 60 may be configured to receive a medication dose released from the stacked medication dose storage disks 40 and the opening mechanism being configured to allow a user to withdraw the released medication dose from the dispenser 60 and thus from the device 10.
The device 10 may also include a timer with a display 200. The timer 200 may operate to unlock a locking mechanism upon passage of a predetermined time period. The locking mechanism may prevent rotation of the rotatable top 50 relative to the assembly 10 until the locking mechanism is unlocked.
The timer 200 and locking mechanism may configured so that rotation of the rotatable top resets the timer and locks the locking mechanism, effectively securing the assembly 10 until the predetermined time period has passed.
The locking mechanism may include a servomotor operating an engagement arm to prevent rotation of the rotatable top 50 relative to the device 10.
The device may be provided with a reload lock mechanism. The reload lock mechanism is configured to allow an authorized user to open and reload the medication doses into the medication dose storage disks 40.
As shown in
According to another embodiment, and as shown in
The timer lock may be designed to be pre-programmed by the pharmacist, technician, or authorized user for the prescribed dosing interval (“every 8 hours”, “twice a day”, “8:00 in the am” etc.). In certain embodiments, the rotatable top 50 can only be rotated by the user and thereby release a dose (for instance a single pill, or combination of pills), based on the control of the timer and timing of the dose. In a preferred embodiment, each rotation or dispensing of a dose resets the process, and may reset the timer, and the container 10 is effectively relocked until the next timed interval. The timer lock may operate in conjunction with an associated application, for instance a computerized application that runs on a smartphone, laptop, desktop, or other computer, that allows an authorized user to override, control, reset and otherwise program the timer lock.
The container of the device 10 may include a base 30 that may be cylindrical and may have the same diameter and may be composed of the same material as the housing 20. The base 30 may be further configured to seamlessly accommodate its insertion and locking onto the housing 20. The base 30 may include a dispenser 60 with features such as a “push-and-pop” spring-loaded drawer, opening or container, a release shoot with a sliding door, a cup that can be twisted out from the base, storage area with a sliding door, or other similar pill release reservoir that stores a released dose in the base 30 until the user engages the dispenser 60 (
With each timed release of a pill dose, gravity can cause the dose to drop out of the respective disk compartment into the dispenser's 60 dose cup or other similar mechanism. The user can then mechanically engage the dispenser 60 or other mechanism to access the dose. The dispenser 60 is configured such that the pill dose remains secured in the base 60. According to another optional embodiment, the dispenser 60 may be electronically linked to the rotatable top and timer mechanism and locked into the closed position except by timed unlock, thereby increasing access security.
A locking mechanism may lock the shaft 70 to the base 30 and prevent the user from direct access to the medication and the disk stack 40. This locking mechanism may be mechanical, key accessed, magnetic, electronic or computerized. The locking mechanism can also optionally require the use of a key, a magnetic or RFID mechanism or card, the entry of data, a code, or the use of an input cord, app, or wireless (e.g., Bluetooth) connection or a similar digital design. The locking mechanism may also lock the housing 20 (preferably in a seamless fashion) to the base 30, thereby preventing the user or other persons from accessing any of the internal components or the contents of the pill disk containers (medication). In a preferred embodiment, only the pharmacist or the person filling the prescription or other authorized user is provided the ability to lock and unlock the housing 20 from the base 30, thereby preventing tampering and misuse or abuse of the medication.
The present disclosure is thus directed to be a hand-held, portable, secure pill or medication bottle or container configured to dispense a single dose (e.g., one or more pills, tablets, capsules, etc.) in a preprogrammed and timed manner. The container is preferably durable, tamper-resistant or tamper-proof, and helps prevent the intentional or accidental exposure to more than the recommended dosage at any one time.
In certain embodiments, a method is provided, which may include two or more of the following steps:
In another embodiment a method is provided and includes the steps of rotating a rotatable top of a medication dispensing assembly as described herein. This rotation causes one or more stacked medication dose storage disks to rotate, thereby causing a storage compartment within one of the storage disks to line up with a gap in an adjacent storage disk, thereby releasing a dose from the storage compartment to a dispensing compartment in the assembly. The method may also include removing the dose from the dispensing compartment in the assembly.
The method may additionally include the step of measuring a predetermined amount of time with a timer and unlocking the rotatable top of the medication dispensing assembly only upon passage of the predetermined amount of time.
In the aforementioned manner, the present disclosure is directed to a medication container for dispensing medicine, such as pills, to a patient in a time-controlled and secure way. The disclosed device and methods provide a number of advantages of previously-known or available devices and methods, including:
While the disclosure provides certain exemplary embodiments, those skilled in the art may make various modifications to the described embodiments without departing from the true spirit and scope of the disclosure. The terms and descriptions used herein are set forth by way of illustration only and not meant as limitations. In particular, although the present disclosure is provided by way of examples, a variety of devices would practice the inventive concepts described herein. Although the disclosure provides various terms and certain embodiments, the scope of the disclosure is not intended to be, nor should it be deemed to be, limited thereby and such other modifications or embodiments as may be suggested by the teachings herein are particularly reserved, especially as they fall within the breadth and scope of the claims here appended. It is expressly contemplated that the features and elements of the various embodiments described herein may be combined and the full variety of combinations and permutations are expressly contemplated by this disclosure. Those skilled in the art will recognize that these and other variations are possible within the spirit and scope of the disclosure as defined in the following claims and their equivalents.
This application claims the benefit of U.S. Provisional Application No. 62/959,649, filed Jan. 10, 2020 and U.S. Provisional Application No. 63/031,380, filed May 28, 2020.
Number | Name | Date | Kind |
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4811764 | McLaughlin | Mar 1989 | A |
5522525 | McLaughlin | Jun 1996 | A |
7689318 | Draper | Mar 2010 | B2 |
Number | Date | Country | |
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20210369563 A1 | Dec 2021 | US |
Number | Date | Country | |
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63031380 | May 2020 | US |