Patent Application
20200383873
The present application is not related to any pending or issued United States of America or foreign patent or patent application.
The present invention generally relates to devices for the distribution/release of medication to patients that are especially beneficial for the timed controlled release of medication that may be either dangerous or addictive or both, e.g., for the timed release of opioids and patient-controlled chemotherapy. Thus, the present invention is directed to devices that receive safe cartridges of medication dosages, to be released on a timed schedule. The present invention devices are thus dispensers that include two separate locks, one being a multi-unit medication cartridge lock functionally connected to a central processing unit and positioned adjacent a cartridge receiver for locking and unlocking the medication cartridge (so that it is secure except for a professional access, such as a pharmacist, dispensary agent or nurse), and the other being a control gate mechanism (lock) connected to the CPU and to a medication release control gate to permit or prohibit activation of the gate for medication dosage release according to a timer. These present invention devices are adaptable for use with pills, capsules and other solid units, and the release chutes may be structured to hold only one medication unit or two.
The following patents are representative of the field pertaining to the present invention:
U.S. Pat. No. 9,558,596 to Nurse et al describes dosing times for medication that may be tracked by taking into account preset dosing sequences and when users indicate that they have taken the medication. The medication may also be kept in its original container. An encoder disk may be attached to a medicine container. The encoder disk may be encoded with a dosing frequency that indicates how frequently the medication should be taken, as well as any other desired information. A base station may be configured to accept and hold one or more medicine containers. The base station may be configured to read the encoded dosage from the encoder disk, an RFID tag, a barcode, or another component capable of conveying dosing information, and detect when the medicine container is removed from and placed on the base station. The base station may also include various indicators of its current state.
U.S. Pat. No. 9,007,875 to Nurse et al describes a medicine station or stand-alone alert device that has a processor having access to memory, wherein the memory stores a control module, and the processor is configured to execute the modules stored in the memory. The medicine station or stand-alone alert device also includes one or more indicators. The control module is configured to periodically check for an external notification from a primary alert device that it is time to take a medication. Upon receiving the external notification, the control program is configured to cause the medicine station or stand-alone alert device to enter an amplified alert mode with respect to the primary alert device via the one or more indicators.
U.S. Pat. No. 8,453,874 to Simpson et al describes a dispenser and method for dispensing pills to patients from cartridges featuring downloadable remotely programmable timer and network communications links, alerting timer, databasing, printer, and battery.
U.S. Pat. No. 7,751,932 to Fedor et al describes a system for monitoring and dispensing medical items that includes a plurality of hook registers. Each of the hook registers includes sensors sensing the removal or addition of a medical item to the storage location on the hook register. Each hook register has a microprocessor connected to the sensor which stores a count of the items added or removed from the location. The microprocessor also includes location identifying information specifically associated with the particular hook register. The microprocessor is periodically polled by a controller which reads and stores the count and location identifying information from each of the hook registers. The controller information is periodically read by a data terminal which is connected through a local area network to a remote computer having a processor and data store. A user of the data terminal is enabled to specify a patient for whom medical items will be used when the items are removed from the hook registers or other storage locations. In addition, the system also monitors inventories of items and levels of usage by users. The system also monitors and controls the dispense of other medical items from box registers as well as controls the dispense of items from secure storage locations such as electronic lock drawers and medicine dispensers.
U.S. Pat. No. 7,467,093 to Newton et al describes a method of tracking and dispensing medical items for use by patients associated with a health care institution that includes storing in a data store in connection with a computer data representative of patients and medical items prescribed for the patients. Authorized users such as a nurse, are enabled to dispense prescribed items for patients through medical item dispensers. A record is included in the data store that the medical items have been dispensed. In an exemplary system medical items that have been dispensed are tracked to the point of giving the item to the patients using portable terminals that are carried to the bedside of the patients. The activity of giving the appropriate medical item to each respective patient is recorded in the portable terminal as medical items are given to a plurality of patients. The data stored in the portable terminal concerning the giving of medical items to patients is communicated through the system and stored in the data store to provide a record that the medical items which were dispensed for a patient were actually administered. In an alternative form of the system patients are enabled to dispense medications on an outpatient basis through a self-service medical item dispenser. In a method of operating such a system a benefit plan associated with the patient is determined from rules stored in connection with data representative of the benefit plan. Payment for dispensed medications is provided by the benefits provider associated with the patient's benefits plan and a co-payment is made by the patient from a credit or debit card account.
U.S. Pat. No. 6,163,737 to Fedor et al describes a medical item dispensing apparatus that includes a dispenser which encloses a plurality of magazines. Each magazine holds a plurality of medical items which in the preferred form of the invention are cylindrical containers. Each magazine includes an opening. A guide and a front gate member are positioned adjacent to the opening. A back gate member is positioned further inward from the opening than the front gate member. The front gate member and back gate member are moved in coordinated relation so that the front gate member enables a medical item adjacent the opening to pass through the opening while the back gate member moves to prevent the other medical items in the magazine from moving toward the opening. After the dispense of the medical item from the magazine the front gate member moves to block the passage of further medical items through the opening while the back gate member moves to enable medical items to move toward the opening. The magazines dispense medical items from the dispenser responsive to a user terminal. The user terminal is operatively connected to a computer which includes a data store which maintains data representative of medical items taken for patients.
U.S. Pat. No. 5,230,441 to Kaufman et al describes a system for dispensing medication that includes a dispensing device unto which a prepackaged cassette can be releasably installed. The cassette contains medication that has been prepackaged in individual pockets along a strip. The strip is wound between a supply reel and a take up reel within the cassette. A control mechanism associated with the dispensing device advances the strip within the cassette by winding the strip onto the take up reel, while unwinding the strip from the supply reel, and while moving a dispensing mechanism also associated with the device into contact with the strip for opening a medication pocket to expel the medication from the strip and out of the cassette.
U. S. Pat. No. 5,200,891 to Kehr et al describes a device for monitoring medication of a patient and for prompting the patient into certain medication taking schedule and/or certain programming steps and routines. The device has a plurality of compartments, each of which may store medication and an electrical signaling system to emit medication alert signals from time-to-time, each of which the signals indicates (a) that medication should be taken, (b) from which compartment the medication should be taken, (c) and the quantity of medication to be taken. If a designated compartment is not opened and closed within a predetermined period of time, the electrical signaling system will sound an alarm. If each designated compartment is opened and closed, the take-medication signal and the alarm (if operating) are turned off and the event is recorded for later review. The device includes a display having a substantially continuous display area having portions thereof closely adjacent to each compartment.
U.S. Pat. No. 5,142,484 to Kaufman et al describes an interactive patient assistance device that houses first and second compartments for storing a first item and a second item away from access by the patient. First and second delivery mechanisms are associated with the first and second compartments for making the first stored item available to the patient in response to a first command signal and for making the second stored item available to the patient in response to a second command signal. The first and second items are delivered to the patient according to schedules stored in resident memory. The schedules may be altered by a prescribed command issued by the patient.
U.S. Pat. No. 4,942,544 to McIntosh et al describes a medication clock for producing a record of a patient in complying with a medication schedule. A data base is provided which stores the time and date of each medication that the patient takes including those medications taken in response to an alarm by the clock as well as medications taken by the choice of the patient. The dosage schedule may be programmed by reading of information written by the pharmacist.
U.S. Pat. No. 4,768,177 to Kehr et al describes a device for indicating when medication should be taken has plural compartments, each of which may store medication. An electrical signaling system emits take-medication signals from time to time, each of which said signals indicates (a) that medication should be taken, (b) from which compartment the medication should be taken, (c) the quantity of medication to be taken from the designated compartment, and instructions for taking the medication. If a designated compartment is not promptly opened and closed, the electrical signaling system will sound an alarm. If each designated compartment is opened and closed, the take-medication signal and the alarm (if operating) are turned off. A reload signal is given once a week, as a reminder to reload the compartments with medication. The device has modular construction. A first module has: (a) one of the compartments, (b) an alarm for producing an audible signal to alert the patient to take medication, (c) a timing signal generator for producing timing signals, (d) a circuit for energizing the alarm in response to selected timing signals, and (e) a switch for turning off said alarm when the medication has been taken from the container in the first module. Each remaining module is a plug-in device which has a compartment, receives timing signals from the first module, sends signals to activate said alarm in response to selected timing signals and a manual switch for deactivating said alarm when medication is taken from the compartment in the module.
U.S. Pat. No. 4,748,600 to Urquhart describes an interactive drug dispenser which actively controls the pattern in which doses of one or more pharmaceutical preparations are administered to a patient. The dispenser is programmed with information concerning an initial dosing regimen, and monitors deviations from that regimen. The dispenser is adapted to calculate from the dosage deviation a dosing error correction factor which corrects a patient's measured plasma drug concentration for deviations from a prescribed dosing regimen, so as to distinguish the effects of patients' dosing errors from suboptimal prescribed dosage regimens.
U.S. Pat. No. 4,725,997 to Urquhart describes a contingent dosing device which actively controls the pattern in which doses of one or more pharmaceutical preparations are administered to a patient. The device is programmed with information concerning an initial dosing regimen, and monitors deviations from that regimen. Based on the acceptability of the calculated deviations, the device may dispense or withhold medication. The invention also includes an automatic drug dosage compliance method using the contingent dosing device.
U.S. Pat. No. 4,663,621 to Field et al describes a medicine cabinet that has a housing and a door. The door is provided with an electrically operated lock which is operable by using the push keys. The opening code for the lock is initially set by inserting four keys into four holes in a four by ten array of holes provided in the casing on the inside of the door. The circuits for the code pre-setting and code inputting circuits are provided on a membrane. The cabinet is provided with a light emitting diode (LED) and a buzzer which can be operated by timing means at set intervals. The LED and the buzzer also operate while the door is open. Additional facilities may also be provided on the cabinet.
U.S. Pat. No. 4,558,303 to Fielden describes an analogue voltage-to-digital voltage converter that has a voltage divider with a plurality of stages each providing an output voltage for comparison with the unknown voltage and in addition provides interpolation between the output voltage to improve the accuracy. Interpolation is effected by adding a ramp voltage to the unknown ramping through a magnitude equivalent to the voltage of at least one stage. With one tap on the voltage divider selected, comparison of the unknown plus ramp voltage is effected successively as the voltage ramps. By noting when the combined voltage reaches the level of one of the divider output voltages and by counting the number of comparisons made from the time when the ramp voltage is at a predetermined magnitude and comparing this with the time taken to ramp through one or a plurality of whole divider stages, determination can be made of the magnitude of the unknown voltage to a fraction of a stage.
U.S. Pat. No. 4,490,711 to Johnston describes a structure provided for assisting a person in keeping track of appointments, times for taking medication or the times for turning on electrical equipment or such. The structure comprises an electronic circuit capable of generating signals representing up to N different pre-set times at which specific events are to occur where N is a selected positive integer such as 20. Switches are then provided, each switch corresponding on a one-to-one basis to a unique pre-set time, such that the user can set those switches corresponding to the pre-set times at which the user desires events to take place. An alarm is provided to indicate in sequence when the actual time corresponds to the pre-set time corresponding to each set switch. The user can only shut off the alarm when the alarm is sounding and the system will then automatically record the number of times during which the alarm has come on and the user has responded to the alarm by silencing it thereby to provide a cumulative count of total events to which the user has responded. A doctor can then check the cumulative count to ensure that a patient has presumptively taken medicines prescribed at selected times in accordance with the programmed schedule on the structure. Because the alarm can only be silenced when it is sounding, accidental silencing of the alarm at any time is prevented. The structure of this invention combines the convenience and ease of an electronic alarm system with the simplicity and permanence of a written record of events.
Notwithstanding the prior art, the present invention is neither taught nor rendered obvious thereby.
The present invention is directed to programmable, refillable medication dispensers with scheduled metered medication unit dispensing. Some embodiments of these devices include extra features, such as child resistant dual activation components; some include communications components, as well.
In some preferred embodiments, the present invention medication dispensers include: a) a main housing having an outer structure with a cartridge receiver for insertion and removal of a multi-unit medication cartridge, and a medication outlet for controllably releasing a medication unit from said cartridge according to a programmed schedule; b) a powered, programmable central processing unit located in said main housing that includes sufficient hardware and software to include a programmable timer for scheduled permitting and scheduled prohibiting of medication unit dispensing; c) a multi-unit medication cartridge lock functionally connected to said central processing unit and positioned adjacent said cartridge receiver for locking and unlocking a cartridge; d) a medication release control gate positioned at said medication outlet and connected to a gate control mechanism; e) said gate control mechanism having a first position prohibiting medication unit dispensing by closing said gate, and a second position permitting medication unit dispensing by opening said gate; and f) a power source connected to said programmable central processing unit. In these embodiments, an authorized medication dispensing person will insert a multi-unit medication cartridge into said cartridge receiver of said main housing and will program said central processing unit to permit a patient user to accomplish dispensing activation according to a predetermined schedule such that when medication dispensing is permitted, said patient dispensing control component may be activated and said gate mechanism may be activated for dispensing, and when medication dispensing is prohibited, said gate control mechanism cannot be activated, and, further, a patient user may then receive said device and activate medication dispensing according to said schedule by operating said gate.
In some preferred embodiments of the present invention medication dispensers with scheduled metered medication unit dispensing, the medication dispenser further includes an externally exposed operate-indicator that has a first setting to indicate that said dispenser is inoperable and a second setting to indicate that said dispenser is operable for controllably releasing a medication unit from said cartridge. In some embodiments of the present invention programmable, refillable medication dispenser with scheduled metered medication unit dispensing, the indicator is selected from the group consisting of a visual indicator, and an audio indicator and combinations thereof. In some of these embodiments, the multi-unit medication cartridge lock includes a solenoid and lock bar having an extended lock position and a retracted unlock position, and in wherein said solenoid is functionally connected to said central processing unit. In some of these embodiments, the medication release control gate includes a gate wall and a gate solenoid functionally connected to said gate, said solenoid having a push bar, said push bar having an extended position maintaining a locked gate and having a retracted position maintaining an unlocked gate.
In some preferred embodiments of the present invention medication dispensers with scheduled metered medication unit dispensing, the medication release control gate is selected from the group consisting of a slide gate, a rotatable gate, and a hinged gate. In some preferred embodiments of the present invention medication dispensers with scheduled metered medication unit dispensing, the gate is a rotatable toggle gate. In some of these embodiments, the rotatable toggle gate extends externally from said main housing on a rotational axle and said patient user may depress said toggle gate to release medication during scheduled times when dispensing is permitted.
In some preferred embodiments of the present invention medication dispensers with scheduled metered medication unit dispensing, there is further g) at least one patient user control component connected to said central processing unit and externally exposed for user dispensing activation that functions as a child resistant feature that must be activated when said gate control mechanism is in its first position and the countdown time has reached zero, to permit medication unit dispensing by opening said gate. In some of these embodiments, the patient user dispensing control component is a button and said button operates in conjunction with said gate as a child resistant feature that must be simultaneously activated to dispense medication. In other embodiments, the button must be activated and then the toggle (gate) would be activated (pressed) to expose the dispensing chute.
In some preferred embodiments of the present invention medication dispensers with scheduled metered medication unit dispensing, there is a spring mechanism connected to said gate that biases said gate to its closed position.
In yet different embodiments of the present invention, the programmable, refillable medication dispenser with scheduled metered medication unit dispensing, includes: a) a main housing having an outer structure with a cartridge receiver for insertion and removal of a multi-unit medication cartridge, and a medication outlet for controllably releasing a medication unit from said cartridge according to a programmed schedule; b) a powered, programmable central processing unit located in said main housing that includes sufficient hardware and software to include a programmable timer for scheduled permitting and prohibiting of medication unit dispensing; c) a multi-unit medication cartridge lock functionally connected to said central processing unit and positioned adjacent said cartridge receiver for locking and unlocking a cartridge; d) a medication release control gate positioned at said medication outlet and connected to a gate control mechanism; e) said gate control mechanism having a first position prohibiting medication unit dispensing by closing said gate, and a second position permitting medication unit dispensing by opening said gate; f) a power source connected to said programmable central processing unit; and g) a communication mechanism connected to said control processing unit and adapted to communicate with a separate programming device for at least performing one of: (a) locking and unlocking a multi-unit medication cartridge; and (b) setting lock and unlock time frames for said timer. Thus, an authorized medication dispensing person (such as a pharmacist, a nurse or other professional) will insert a multi-unit medication cartridge into said cartridge receiver of said main housing and will program said central processing unit to permit a patient user to accomplish dispensing activation according to a predetermined schedule such that when medication dispensing is permitted, said gate mechanism may be activated for dispensing, and when medication dispensing is prohibited, said gate control mechanism cannot be activated, and, further, a patient user may then receive said device and activate medication dispensing according to said schedule by operating said gate to dispense medication. In some of these embodiments, the communication mechanism is selected from the group consisting of a wire port and a wireless transmitter receiver. In some of these embodiments, the communication mechanism includes both a wire port and a wireless transmitter receiver. In some of these embodiments, the device further includes an externally exposed operate indicator that has a first setting to indicate that said dispenser is inoperable and a second setting to indicate that said dispenser is operable for controllably releasing a medication unit from said cartridge. The indicator may be selected from the group consisting of a visual indicator, and an audio indicator and combinations thereof. In some embodiments, the audio indicator is an audio alarm.
In some of these embodiments with a communication mechanism, the multi-unit medication cartridge lock includes a solenoid and lock bar having an extended lock position and a retracted unlock position, and in wherein said solenoid is functionally connected to said central processing unit. In some of these embodiments, the medication release control gate includes a gate wall and a gate solenoid functionally connected to said gate, said solenoid having a push bar, said push bar having an extended position maintaining a locked gate and having a retracted position maintaining an unlocked gate. The medication release control gate may be selected from the group consisting of a slide gate, a rotatable gate, and a hinged gate. It is preferred that the gate is a rotatable toggle gate. In some of these embodiments, the rotatable toggle gate extends externally from said main housing on a rotational axle and said patient user may depress said toggle gate to release medication during scheduled times when dispensing is permitted.
In some of these embodiments with a communication mechanism, there is further h) at least one patient user control component connected to said central processing unit and externally exposed for user dispensing activation that functions as a child resistant feature that must be activated when said gate control mechanism is in its first position and the countdown is at zero, to permit medication unit dispensing by opening said gate.
In some of these embodiments with a communication mechanism, there is a spring mechanism connected to said gate that biases said gate to its closed position.
In some of these embodiments with a communication mechanism, the communication mechanism is a wireless transmitter receiver and preferably it is an NFC reader.
Additional features, advantages, and embodiments of the invention may be set forth or apparent from consideration of the following detailed description, drawings, and claims. Moreover, it is to be understood that both the foregoing summary of the invention and the following detailed description are exemplary and intended to provide further explanation without limiting the scope of the invention as claimed.
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate preferred embodiments of the invention and together with the detailed description serve to explain the principles of the invention. In the drawings:
The present invention is directed to unit dosage medicine dispensing devices that receive cartridges of medication dosages to be released on a timed schedule. The cartridges are safe because they are locked and are thus set up to deny access for medication abuse. The present invention dispenser devices include two separate locks, one being a multi-unit medication cartridge lock functionally connected to a CPU and positioned adjacent a cartridge receiver for locking and unlocking the medication cartridge (ergo, secure except for a professional access, such as a pharmacist, dispensary or nurse), and the other lock being a control gate mechanism connected to the CPU and to a medication release control gate (such as a toggle) to permit or prohibit activation of the gate for medication dosage release according to a timer.
The following is an example of how a present invention preferred dispenser device would work: a doctor would give the user patient a prescription for opioids or other dangerous drug, and the user patient would bring this script to the pharmacist. The pharmacist would take an empty cartridge and fill it with the correct opioid or other medicine, or would take a full cartridge from a pharma manufacturer. This cartridge would be color coded to a properly sized gate (e.g., a toggle). The pharmacist would then assemble both the Toggle and the Cartridge to the dispensing package. Both would be locked in place and could not be removed without breaking the device.
The pharmacist would then, using his computer, program the unit with the prescription's dosing instructions. The complete package would then be given to the user patient for use after instruction by the pharmacist. A display clock on the unit (a countdown clock is preferred) would tell the user patient when he could access a tablet. The user patient sees the clock count down to zero, at which time the CPU would activate a gate (Toggle) with a solenoid or equivalent mechanism) for medication release. The patient would have 1 hour to access the dose or the unit would automatically re-lock until the next dose is due. To access a tablet, the user patient would tilt the unit, allowing a single tablet to enter the Toggle chute, then push down on the toggle and one tablet would be dispensed. The Toggle is spring loaded and, when released by the user patient, it would automatically re-lock until the next dose is due.
When the cartridge is empty, the user patient would bring the device back to the pharmacy for either a re-fill or return of the deposit on the unit. If the dispenser or cartridge shows damage or tampering evidence, the refund would not be issued and a re-fill would not be honored. In preferred embodiments, the Toggle and the Cartridge will be made of clear plastic, allowing the user patient to see the tablet move to the slot in the Toggle for dispensing. Also, in some preferred embodiments, an additional button must be pushed to open the gate (Toggle), and this creates a simultaneous dual action child resistant requirement.
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Although particular embodiments of the invention have been described in detail herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those particular embodiments, and that various changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of the invention as defined in the appended claims. For example, the actual shape of the main housing may be any of numerous possibilities as long as its functionality as described is not affected adversely.
