CONTAINER FOR DISPENSING MEDICATION
20210369563 · 2021-12-02
Inventors
Cpc classification
A61J7/0445
HUMAN NECESSITIES
A61J7/0472
HUMAN NECESSITIES
A61J7/0436
HUMAN NECESSITIES
International classification
A61J7/04
HUMAN NECESSITIES
Abstract
A medication container system, device, and related methods are disclosed for time controlled and secure dispensing of medicine, such as pills, to a patient. The disclosed systems, devices and methods include a plurality of vertically stack of disks which engage adjacent disks in a rotational manner and are housed within a secure container. The disks are configured so that as they rotate they release the doses (e.g. pills) that they hold to a release portion of the device. The disclosed systems, devices and methods provide a number of advantages over previously-known or available devices and methods.
Claims
1. An assembly for a medication dispensing system comprising: a plurality of stacked medication dose storage disks having a generally flat circular shape, each disk having a plurality of defined storage compartments for holding individual doses of medication, each storage compartment having two side walls, the side walls extending radially outward from near the middle of the circular disk, one or more of the stackable medication dose storage disks having a gap configured to allow a pill to pass from a storage disk above it, through the storage disk and to a dispenser below the plurality of stackable medication dose storage disks, the gap having two side walls, the side walls extending radially outward from near the middle of the circular disk, the plurality of stackable medication dose storage disks being arranged so that when the disks are stacked and the gaps of several of the disk are aligned, a pill can pass through the gaps of several stacked medication dose storage disks to a dispenser.
2. The assembly of claim 1, further comprising: a top wall for each storage compartment, the top wall being provided above the compartment.
3. The assembly of claim 1, further comprising: a flat planar separator, the separator having a gap configured to allow a pill to fall through said gap when a storage compartment on an adjacent storage disk is aligned with the gap.
4. The assembly of claim 1, further comprising: a plurality of flat planar separators, one separator being provided between adjacent storage disks so as to separate individual doses of medications from the doses in the adjacent storage disks, each separator having a gap configured to allow a pill to fall through said gap when a storage compartment on an adjacent storage disk is aligned with the gap.
5. The assembly of claim 1, further comprising: a shaft extending through the central axis of the plurality of stacked medication dose storage disks such that a set of the plurality of stacked medication dose storage disks can rotate about the shaft.
6. The assembly of claim 1, further comprising: a lower engagement mechanism on a medication dose storage disk included within the plurality of stacked medication dose storage disks; an upper engagement mechanism on a medication dose storage disk included within the plurality of stacked medication dose storage disks; wherein the lower engagement mechanism on one medication dose storage disk is configured to engage the upper engagement mechanism on an adjacent medication dose storage disk such that when the lower engagement mechanism and the upper engagement mechanism are engaged, the two medication dose storage disks rotate together.
7. The assembly of claim 6, wherein the upper engagement mechanism and the lower engagement mechanism are selected from the group consisting of an edge, bevel, tab, block and protrusion.
8. The assembly of claim 6, wherein a plurality of medication dose storage disks each have an upper engagement mechanism and a lower engagement mechanism.
9. The assembly of claim 1, further comprising: a rotatably attached top; an outer shell; and a base, wherein the outer shell is configured to securely engage the top and the base and thereby provide a secure container for the medication to be stored and dispensed therefrom.
10. The assembly of claim 9, wherein the outer shell and the base are formed as a single component.
11. The assembly of claim 9, further comprising: a lock mechanism, the lock mechanism configured to only allow release of a medication dose from the assembly after a predetermined period of time has passed.
12. The assembly of claim 9, further comprising: a dispensing compartment in the base provided with an opening mechanism, the dispensing compartment being configured to receive a medication dose released from the stacked medication dose storage disks and the opening mechanism being configured to allow a user to withdraw the released medication dose from the assembly.
13. The assembly of claim 9, further comprising: a timer with a display, the timer working to unlock a locking mechanism upon passage of a predetermined time period, said locking mechanism preventing rotation of the rotatable top relative to the assembly until the locking mechanism is unlocked.
14. The assembly of claim 13, wherein the timer and locking mechanism are configured so that rotation of the rotatable top resets the timer and locks the locking mechanism, effectively securing the assembly until the predetermined time period has passed.
15. The assembly of claim 13, wherein the locking mechanism comprises a servomotor operating an engagement arm that prevents rotation of the rotatable top.
16. The assembly of claim 1, further comprising: a reload lock mechanism, wherein the reload lock mechanism allows an authorized user to open and reload the medication doses into the medication dose storage disks.
17. A method comprising the steps of: rotating a rotatable top of a medication dispensing assembly according to claim 1 to cause 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, and releasing a dose to a dispensing compartment in the assembly.
18. The method of claim 17, comprising the steps 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.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] 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:
[0014]
[0015]
[0016]
[0017]
[0018]
DETAILED DESCRIPTION
[0019] 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.
[0020] 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
[0021] 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.
[0022] 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 (
[0023] As shown in
[0024] 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.
[0025] Referring to
[0026] 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.
[0027] 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,
[0028] 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.
[0029] 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.
[0030] 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.
[0031] 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.
[0032] Referring to
[0033] 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.
[0034] 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.
[0035] 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.
[0036] In a preferred embodiment, housing 20 and the base 30 are formed as a single component.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] 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.
[0041] The locking mechanism may include a servomotor operating an engagement arm to prevent rotation of the rotatable top 50 relative to the device 10.
[0042] 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.
[0043] As shown in
[0044] According to another embodiment, and as shown in
[0045] 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.
[0046] 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 (
[0047] 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.
[0048] 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.
[0049] 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.
[0050] In certain embodiments, a method is provided, which may include two or more of the following steps:
1. A prescriber designates prescription medication, dose, frequency, and quantity.
2. A pill stack delivery disk is selected by a pharmacist or other authorized user for instance based on pill number, size and/or volume. The pills may then be loaded into the disk by pharmacist or authorized user. A plurality of loaded disks may be stacked on the shaft.
3. The twisting top timer may be programmed by the pharmacist or authorized user.
4. The base may be locked onto the shaft and stacked pill disks.
5. The durable outer shell and twisting top section may be slid over the components and locked onto the base.
6. The timer countdown may start by press of a button or, for instance, once the top has been rotated by a predetermined amount or a fractional turn.
7. The twisting top only unlocks for the next rotation and dose release when timer countdown is complete or has passed a certain amount of predetermined time.
8. Upon unlock, the patient or other person may rotate the top to cause one or more disks to rotate, thereby releasing a dose as described herein. A separate lock may be provided to ensure that only an authorized user is able to rotate the top. For instance, a manual or digital code or key that must entered to allow rotation of the top. This provides a form of multifactor authentication to release of a given dose.
8. The timer screen may display a time countdown to the next dose and the number of pills remaining along with related information.
9. When empty, the container can be returned to the pharmacist/authorized user for unlocking, reset, and refill.
While the various steps of the method listed above are enumerated, it should be understood and is expressly contemplated for this disclosure that the method is not limited to the particular order or sequence steps shown above.
[0051] 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.
[0052] 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.
[0053] 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:
1. The medication container is specifically adapted to address outpatient day-to-day safe dosing of controlled and high-risk medications.
2. The hand-held size is similar in size to existing pill bottles.
3. The system is inexpensive and simply designed for practical use, thereby allowing for inexpensive manufacture and hundreds of millions of units in a real-world application.
4. The timed dosage allows for secure timed release of single or multiple pills, and the container is otherwise locked.
5. The system can requires user intervention to reset the timer, for instance, rotation of twisting top and release of a predosed medication to a drawer/receptacle once the timer counts to zero or another “release” state.
6. The system is tamper resistant for patients, family, and children.
7. The system prevents exposure to full pill quantities, for instance, several hundred pills simultaneously (15 billion+pills dispensed per year in US).
8. The system decreases intentional and unintentional overdose risk (100 million+prescription ODs per year).
9. The system decreases poisoning risk to children and pets (129,000 analgesic poisonings, 18% all fatal poisonings are pain medications).
10. The system decreases risk of diversion (access to diverted pills is a huge contributing factor to addiction and overdoses).
11. The system decreases misuse (overuse, early use, abuse, increased dose).
12. The system is expected to reduce risk addiction due to timed release (no escalation of use possible as time controlled).
13. The system has the potential to save thousands of lives per year (23 thousand deaths annually in US alone directly from prescription medication and large percentage of all fatal ODs—70 million/year have prescription medication in system).
14. The system helps to ensure a prescription is dosed as prescribed in single or multiple units and in a timed fashion.
15. The system gives pharmacist/authorized users sole access to large pill quantities.
16. The system reduces liability risk for prescriber, pharmacy, pill manufacturer.
17. The system permits larger pill volumes to be prescribed safely (therefore less frequent fills).
18. The system permits high risk medications to be utilized safely for those who need them.
19. The system is reusable and environmentally friendly, dramatically reducing plastic bottle waste (over 100 M plastic pill bottles per year).
20. The system is envisioned to be scalable if nationally mandated for use with all CMs (400+M scripts per year) due to low-cost design/manufacture and reusability.
21. The system is envisioned for use with any high-risk or controlled medication as well as any medication requiring timed administration.
[0054] 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.