MXPA99004288A - Liquid medication dispenser apparatus - Google Patents

Abstract

A liquid medication dispenser apparatus (10) which provides for user-friendly medication measurement and compliance. The apparatus (10) measures and dispenses liquid medication doses and records the time and dose sizes for up to one year. The recorded information can then be downloaded to a personal computer (PC) for evaluation of patient compliance. A disposable, motor driven pump (36, 66, 80) is used to provide a very wide range of medication dispensation volumes, while maintaining full accuracy and reducing the risks of patient errors as might occur with a manual dispense system.

Description

LIQUID MEDICINAL DISPENSER APPARATUS BACKGROUND OF THE INVENTION Field of the Invention This invention belongs in general to the devices and. methods for supplying medicament, and more particularly to a liquid medicament dispensing apparatus that periodically verifies compliance with a plan and determines a compliance rating indicating whether the liquid medicament was stocked at predetermined times and at predetermined dose levels.

Description of the Previous Technique Medication containers often need to take an adjusted dose of medication or drugs at regular intervals of time. The omission on the part of the people to take the requisite medjLcament9 do.sis. .at appropriate time intervals, results in levels. serum, incorrect blood of the drug, and may ultimately lead to results REF .: 30216 unfavorable clinical. For various reasons, incorrect dosages of liquid medication are often taken by patients. Doses of liquid medication are typically measured by emptying the medication into a spoon. - small container before taking the medication.

This way of measuring the dose is prqpens.a imprintacisionjes and can result in wasted medicine, and not jlaoentera apaaiencia due to spills during the measurement. In addition, the amount of liquid medication that remains in a container can not be easily determined, in a manner contrary to solid medications and where the patient can count the number of tablets present, and thus the patient can be left alone. medication., resulting in doses of omitted or sautéed medication. In addition, patients who must take numerous medications on a regular basis can easily lose track of the time and which particular medication was most recently taken, resulting in patient omission of the required doses or exceeding the requirement. of dosing ^ Frequently ^, ipjs re que imi ntos e, synchronization vary for the doses of different drugs and lead to further confusion on the part of the patient and. to error in taking the different medications at, correct time intervals. Consequently, there is a need for a liquid medication dispenser which alerts the patient to the correct time intervals for taking liquid medications, which keeps track of and displays the number of doses, of the liquid medication taken, and which measures quickly, consistently and accurately, and supplies the doses of liquid medication. The present invention satisfies these needs, as well as other, and in general overcomes the deficiencies found in the prior art.

BRIEF DESCRIPTION OF THE INVENTION The present invention pertains to. a liquid medication dispenser that verifies periodic compliance with, the treatment ^ This is designed to be extremely convenient and easy to use by patient. time that still provides characteristic ^ of the state of the technique for the provider, of the health care. It measures and delivers a dose of liquid medication, recording time and dose sizes, as well as information pertaining to compliance with a scheduled treatment plan, for up to one year or more. The device p > It can be programmed, and the information retrieved from the device, using a pers.on.al computer. The information downloaded from the device can then be used to evaluate the patient's compliance with the scheduled treatment plan. The device uses a pump operated with rno oj :,, dispose of it and a, reservoir of medicament to provide a very wide range of volumes, while • maintaining •, the -complete precision and reducing the risks of patient errors as they can happen with a manual assortment system. In general termsThe invention comprises a medication cassette with an interchangeable reservoir and a pallet and a plurality. of fluid path, the means to adjust the amount of medication administered ^ means. of stopwatch to measure time, memory means for storing data, screen ios. - to provide visual and audio output to a user, and. the processing means of 9n ro to periodically check and record the time and number of doses of medication stocked, to alert the user of the time to take the medication doses, to periodically check the amount of medication remaining in the medication cassette , and to compute a compliance score. Also included with the invention are the means of, preferably audible alarm to alert a user, and a communications interconnection to connect the control processor means pn. an external computer. A liquid-filled valve assembly and a pump are used to supply the liquid medicament from the reservoir and through the assembly of the fluid path. - By way of example, and not limitation, the control processor means preferably comprises a conventional microprocessor, and another programmable data processor, which may be in. a digital or analog format. The chronometer means comprises first and. second chronometers interconnected with the microprocessor, with the first stopwatch that. It preferably comprises a 32 KHz synchronization circuit for verification or monitoring of real time. pajrt.e • dl microprocessor, and the second chronometer preferably comprises a 4 MHz clock for basic processing by the microprocessor .. The microprocessor can also include an internal "watchdog" synchronizer " The screen means preferably comprises a multi-field liquid crystal display, or a light emitting diode (LE.D) screen operatively connected to the microprocessor. The audible alarm means preferably comprises a piezoelectric warning alarm device, which is operatively coupled to the microprocessor. The liquid dispensing pump has a pump motor with a rotation sensor associated with the rod or motor rotation shaft. The rotation sensor is preferably an optical rotation encoder and is operatively coupled to the microprocessor to allow the monitoring or periodic checking of the drug assortment events. The memory means preferably comprises at least one random access memory. (RAM) of 2K which is accessible by the microprocessor. The interconnection of communications - preferably comprises an optical interconnection operatively coupled to the microprocessor / and which receives a. interconnection cable for connection to a personal computer.

An object of the present invention is to provide a liquid medicament dispensing apparatus which uses standard 50 ml medicament bottles, has a disposable fluid path completely enclosed in the plastic dispenser case for easy portability, has an interval of sis of 0.1 ml at í > ml ^ has a solution of .l ml, shows high precision at 5 ml, has only two user keys - a Display / Dose key and an Alarm / Increment key, uses a glass, liguid (LCJ) screen) a memory of at least one year at 2 doses per day (loadable up to personal computer) ^ has at least seven months of battery life, uses common "AA" type alkaline gate for power, and uses a pump technology for a wide range of volumes and less error on the part of the patient . The injection provides the dose of a median dose of a liquid therapeutic drug to a patient, and records the timing and amount of dose dispensed. The history of the dose and / or timing can be validated by a patient by a doctor or by another health care provider, either as raw data or as a calculated "compliance rating." The invention is particularly suitable for supplying an immunosuppressant drug. liquid a patient, with transplant .., and can be adapted to supply multiple drugs. The objectives and. Additional features of the invention will be set forth in the following portions of the specification,. wherein the detailed description is for purposes of fully describing the preferred embodiments of 1.a. injection and without placing limitations on it.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will be more fully understood by reference to the following drawings, which are for illustrative purposes only: Figure 1 is a block functional diagram of a liquid dispenser according to the present invention.

Figure 2A to Figure 2C is a schematic diagram of a liquid jet apparatus according to the present invention, which corresponds to the functional block diagram shown in Figure 1.

Figure 3 is a side elevational view of a liquid jet apparatus according to the present invention.

Figure 4 is a front elevation view of a liquid dispensing apparatus according to the present invention.

Figure 5 is a top plan view of a liquid spout apparatus according to the present invention.

Figure 6 is a cross sectional view of a liquid jet apparatus according to the. present invention, taken through line 6 6 showing the disposable cassette assembly in place with a liquid medicament bottle attached.

Figure 7 is a partial cross-sectional view of the disposable cassette mounting portion of Figure 6, with the liquid medicament bottle removed.

The ... Fig. 8 is a diagrammatic view of a basic screen according to the invention, showing three fields of observation.

Figure .9 is a diagrammatic view of e. a screen according to the present invention.

Fig. 10 is a diagrammatic view of a third screen according to the present invention, DETAILED DESCRIPTION OF THE INVENTION With reference more specifically to the drawings, for illustrative purposes the present invention is exemplified in the general According to the configuration and the details of the parts, without departing from the basic concepts, cpmp are described herein.

Referring first to Figure 1, a block diagram of a liquid medication spout 10 according to the present invention is generally shown. The dispenser 10 generally comprises a 12v control microprocessor which provides the complete control functions of the device, including the sterilizer.The periodic record of the number of doses of medication stocked from a medication bottle 14 alerting the user of the time for taking the medication doses, verifying the quantity of medication remaining in the medication cassette 14, and computa.do.a compliance rating, feedback to the user by the device is pirppprcipnada by a visual screen 16 and an audible alarm 18. The memory 20 is provided, for the storage and retrieval of data, and various keys / interrptor 22 are provided , 24, _26 28 for the general operation? / O of the user. The stopwatch and clock operations are provided by a pair of clocks 30, 32. A serial interconnect 34- is also provided to e ect the device to an external computer. The liquid medication is stocked by operation of the pump motor 36 which. is mechanically coupled .al. cassete of medication l é. A rotation sensor 38 periodically verifies the rotation of the rod or motor shaft .36 of the. pump to detect the quantity of liquid assortment. Referring also to Fig. 2a to Fig. 2C, which shows an exemplary schematic diagram corresponding to the set of control circuits shown in Fig. 1, the control microprocessor 1.2 preferably comprises a conventional icroprocesadpr, or other processor of programmable data, which can be in the digital or analog format. In the embodiment shown, the control microprocessor 12 comprises a microcuit (microchip). PIC16LC64A or a similar device. The pump motor 36 is preferably coupled to the control microprocessor 12 by the driver in the form of a simple transistor pair where one transistor turns the motor on in one direction and the other transistor turns off the motor to apply an electronic brake function. Alternative microprocessors, which may be used with the invention include the National Semiconductor COP842CJ and COP988CS microprocessor; Microchip PIC16C57, NEC 75304, Motorola 68HC05, 'Phillips 80C51, -Toshiba TMP87CH800LF, O i MSM64162 and Hitachi. The control microprocessor 12 preferably includes - a. oscillator. of independent, integral warning and the stopwatch as they are conencipnalmente in such devices. The alert timer runs continuously, uses very little energy, and the alarm clock is periodically cleared as it may happen if the computer logic endowment (SQFTWAREJ cuts the communication for any reason, this will be interrupted and will cause a readjustment of the processor The microprocessor preferably provides the flags to differentiate between a readjustment alert and a power up readjustment, allowing the logical envelope to simply continue if a failure occurs, thus, the clock and other data. Current streams are lost or corrupted.The screen 16 is preferably a multi-field liquid crystal screen, commercial grade, conventional (LCD) with an observation mode ppr reflection, with a ngμl9-d observation at 12 o'clock, and a multiple electric actuator, the screen 16 is preferably driven by the computer hardware directly from the computer. of the spikes of the control processor 12 to reduce the space of the circuit board and the number of welding joints required. Alternatively, the screen 16 could be operated using a conventional actuator circuit, either internal or external, to the control microprocessor 12. However, microprocessors with LCD accionadpr.es tend to increase the cost. The audible alarm preferably comprises a piezoelectric element, low energy, low cost, small, conventional, which can. er used to generate alarms in the form of high frequency tones in the range of 3 to 4 KHz - The device is similar to those used in watches with alarms and small alarm clocks. For the storage of important data, the memory 20 preferably comprises the non-volatile random access memory (RAM), or the like, which allows the batteries to be changed or the disturbances of. energy occur without loss of data or synchronization time. The preferred memory is a conventional 2K EE memory microcircuit such as the 24LC16B Microcircuit, which operates in a low voltage range. The internal memory to the microprocessor. particular selected,. it can be alternatively used. The synchronization functions are carried out by two time base clocks. For the microprocessor shown in Figure 2, the clock 28 is preferably a 4 MHz clock that is used for basic processing when the microprocessor is awake. On the other hand, the clock 30 is preferably a 32 KHz clock that runs continuously to provide a time base for a ten minute real-time clock.

By stopping the clock most of the time at 2 MHz faster, substantial battery power is saved. With reference to Figure 3 through Figure 5, a .manμal housing 40 contains the functional components of the spout 10. "The housing 40 includes a physical assortment trigger 42 which operates the assortment switch 26 (Figure 1 and Figure 2B) With reference more particularly to Figure 5, the upper portion 44 of the housing 40 includes a user control panel 46. The control panel 46 includes the display 16, which has three observation segments 48a, 48b, 48c, The control panel 46 also includes the alarm / increment key 22, the display / dose key 24, an alarm light .50 of "dose taking" which is a conventional light emitting diode (D3 in the Figure 2B), and a conventional phototransistor 52 (D4 in Figure 2B) .. The liquid medicament is stocked through the lower portion 54 of the housing 40., Note that the alarm light 50 also functions as the emitting portion of the serial interconnect 34, while the phototransistor 52 functions as the receiving target. Alternatively, a dedicated light could be used for the alarm light 50 and the serial interconnect 34 could comprise a conventional infrared transceiver, on., in the case - the jet 10. In any of these modalities, to communicate with a personal computer (PC) or the like, an interconnecting cable (not shown) is used. The interconnecting cable preferably has an infrared transceiver in a housing, small on an extreme, and a serial connector of either 9 pins or 25 pins on the other end,. The housing on the interconnecting cable could be adapted to fit over the housing 40, so that the infrared transceiver can be placed adjacent to the emitter 50 and the receiver 52. The conventional synchronization and ordering protocol. it is then used for communications. It will be appreciated that other conventional communications means may be employed, including serial cables which are plugged into the dispenser 10, modems, telephone links, radio links, connections. of printer and the like. With reference to Figure 67 the spout 10 is preferably constructed on two printed circuit boards (PCB) 56 58, The PCB 5 $ carries most of the electrical components while the PCB 58 mainly carries the display 16. The display 16 it is preferably connected to the control microprocessor 12 and related components through a flexible connector or the like (not shown), and is preferably mounted at a right angle to the PCB 56. Alternative configurations could also be used. The jet 10 is preferably energized by one or more batteries 60 t as alkaline batteries "AA'V alkaline" AAA ", or lithium" 2/3 A ".Other various batteries such comp versions, 9 volts, button cells, etc. can be alternatively used In general, consideration must be given to the voltages required by the microprocessor - used with the invention, the life of the battery with a configuration No electronics and constraints on the size, cost and availability of replacement. Alkaline cell batteries are currently preferred due to their low cost, long life and correct voltages for the microprocessor. ^ 1 rotation sensor .38 preferably comprises an optical sensor which detects each revolution of the bar 62 of the motor 36 of the pump.

The rod 62 is in turn coupled to a connecting rod 64 which operates a piston 6.6 of pump e, n-.the measurement cassette 14. This in turn detects each stroke of the piston 66 of the pump, during the assortment .. The output signal from the rotation sensor 38 is used. by the control microprocessor 12 to periodically check the doses of medicines assorted, and to calculate the remaining doses in the medicine cassette 1. The optical sensor preferably comprises a crescent-shaped disk 68 coupled to the bar 62, which interrupts the light path between a conventional optical / sensor pair 0 (DI, D2 in Figure 2) during the rotation of the optical sensor. bar 62. It will be appreciated that magnetic rotational sensors or other techniques could be used as alternatives to emitter / optical sensor pair 70. Cpn • reference also to Figure 7 ,. the medicament cassette 14 comprises a removable assembly that snaps into the lower portion 54 of the housing 40, by means of a resilient latch 7.2 which is fitted to a corresponding slot 74 in the housing 40. The medication cassette.14 includes a liquid medication bottle 76 or similar reservoir for the storage of medicament to be assorted. The size of the bottle 76 of liquid medicament is preferably about 50 ml which is a standard size. The bottle 76 of liquid medication is screwed dent.r? of a receptacle. 78, which is secured to its site and placed adjacent to the orifice 80 d of the pump, or air ventilation tube 82 coupled to a hydrophobic vent 84, is provided for the inlet of the bottle 76 of medicament ^ liquid to help with the pumping operation. The rod. Connection 64 is coupled to the shaft 62 of the plunger 36 by means of an alternating movement crank 86 for the operation of the piston 66 of the pump, and the liquid medicament is supplied through a flap valve hinge 88. switch 2§ of the bottle (Figure 1, - Figure 2B) is tilted by one. switch lever 90 which makes contact with the liquid medication bottle 76 provided that the medical cartridge 14 is installed or removed. With reference also to Figure 8- to Figure 1-0, the dispenser 10 operates in general according to the following criteria. 1. Alarm and Stopwatch Features The 10switch includes the alarm and stopwatch functions which - provide a simple reminder to the patient to take the medication regularly. - These reminders include a countdown timer, the dose size indicator and ... visual and audible alerts. Figure 8 shows the basic screen configuration for the lOj jet. where a group of upper digits 92 is shared between a countdown timer value, the value of the "left dose", and the size value of the dose. Pressing the screen / dose key 24 will- oscillate through these screens.

The countdown timer is shown in hours and minutes and represents the. time until 'the next dose. This is initiated whenever "a dose is stocked, with a time value programmed by the health care provider." The countdown timer is not visible when the dispenser 10 is in a sleep mode, to save energy but the time value is kept continuously in memory The value of the countdown timer is displayed visually whenever the dispenser 10 is awake from the sleep mode, or when the countdown timer reaches zero signaling, which is the Time to take a dose The value of the dose size - it is a whole number in milligrams that is programmed by the health care provider, and visually shows the dose size along with a "milligram" icon 94 to show 1.a • amount of liquid medication that is going to be filled in. The countdown timer and the dose size values are also displayed during the last hour before the time of the dose, - Alternating between each of the others approximately three seconds. Also, if the dispenser 10 is in a sleep mode it can be awakened by pressing a key, and the countdown timer will display visually until the dispenser 10 goes to sleep again or Jiasta the display / dose key 24 be pressed to go to another screen. Those skilled in the art will appreciate that other screen parameters in the apparatus could easily be programmed. When the yalor of. the downward count reaches zero as shown in Figure 9, the "dose taking" icon 96 cpmienza to .flare. on screen 16, e hears an audible tone of alarm 18 (Figure 1, Figure 2AJ, 50 light of dose to a (Figure 5) flashes, and an alarm icon 98 flashes, Until the dose is complete, the visual indicator continues to flash and the audible tone is repeated. Once every 10 minutes. Note that the patient can take the dose at any time, and the countdown timer will not prevent taking an early dose. Note also that the alarm can be switched on and off oscillating by pressing the alarm / increment key 22. 2. Dosage Assortment To deliver a dose of medication, the patient holds the dispenser 10 on a drinking glass or other container. The assortment button 42 (Figure 3 &Figure 4) is then depressed and held down for one to two seconds until an audible alert is heard ... The assortment button 42 is then released to begin the assortment action. For security / the assortment button 42 should preferably be released • within a second or the assortment action will occur. This synchronized interaction will help. preventing accidental assortments of medication that may occur while moving or pumping the assortment button 42. Alternatively, a safety latch or locking mechanism could be employed instead of the aforementioned pressure and release mechanism. Once turned on, the dispenser 10 will always deliver the volume of medication programmed. The dispenser i will then sound a termination tone at the end of the dose. After the dose, the digital adjustment will automatically show the whole number of doses left and μn icon 100 of "Dpsis, D j adas "will appear as shown in Figure 8. If no other keys are pressed, the dispenser 10 will automatically go into sleep mode after a pre-set period of time .. In addition, once. dose, for safety and compliance purposes, a subsequent dose can not be dispensed until a pre-established period of time elapses, as determined by an internal timer.This period of time may, if desired, be shorter than the time of the next dose; doing so will allow the patient to take the next dose earlier than scheduled, if desired, but not. so early that the patient could overdose. Alternatively, the timer can be disabled jointly, thereby increasing this protection. 3. Dosage Screen Icons The invention shows the doses that are to be taken on a given day by observing segment 48b of screen 16 as shown in Figure 8. The dose number is shown as an integer value 102, and a Checkmark 104 is used, to identify each dose taken in a 24-hour period from 1 AM ^. So, the screen will be in the form of "l", "2" "and so on for the doses taken .. The verification marks are cleared, at 1 AM each day, and each dose causes another icon to appear, (always-that the screen was awakened.) Up to four doses can be prescribed per day, - and Figure 8 through Figure 10 show the screen format after they have Four doses have been taken. 4. ^ Dosage Adjustment The dose size is initially. adjusted by the health care provider using a computer person.! coupled to the serial interconnection 34. The dose sizes can be adjusted in increments of 0..1 ml from 0. 1 ml to 5.0 ml. Screen 16 shows this value in t of the milligrams at a rate of .100 mg per milliliter. Referring also to Figure 5, the patient may change the dose size by pressing and holding the screen key 2 or button and the button 22 4e alarm / increment together for approximately three seconds,, Any other sequence will abort the change. Screen 16 will then turn on, to show the size, of 1st dps.is, icon 94 of "milligrams" will flash, and an audible tone will be heard. While the screen / dose key 24 is held down, the alarm / increment key 22 is then pressed repeatedly to increase the size of the dose to the desired amount in increments-of. 10. mg., The al- will evolve from 500 mg again to 10 mg and then repeat the 10 mg increments for a total of fifty steps. While the dose size is changed, pressing and holding the alarm / increment key 22 will automatically increase the value by approximately two or three steps, per second. The size of the dose is increased in a temporary record during this procedure. Referring also to Figure 10, an example can be seen in a screen showing the number of dpsis left in the medication cassette 14. The effective volume withdrawn from the cassette, from medication 14 is maintained internally and the remaining doses The current dose sizes are computed and displayed visually. Since the initial volume and sizes of do.sis are poor, the remaining doses are easily detned. Preferably, the initial vplumen is divided by the size of the dose to detne the total number of available doses, and then the number of assorted doses subtracted from the initial number. Alternatively, the volume of doses dispensed could be subtracted from the initial volume. and the remaining volume "divided by the size of the dose to detne the number of remaining doses, none of the doses will be filled and an audible alarm will sound if there is insufficient medication, to stop a full dose, -the 100 icon of dose size and dose left are always shown after _ that a dose is taken.

. Capsule Removal Alarm An audible a.-a.m. is sounded if the medicament cassette 14 is removed with more than 6 ml left in the bottle 76. When the medicament cassette 14- is replaced, the delivery counter It will be preserved in its previous value. This sequence presumes that the drug cassette 14 was removed for inspection only, and partially reinstated complete. For this early withdrawal and reinstallation sequence, the number of doses left and the dose icon 100 left will flash until the drug cassette 14 is replaced. However,. if the blood pressure is pressed - the screen / dose key 24 for the first five seconds after the removal of the medicament cassette -1.4, the counter will readjust again to 50 ml. This is an overlap of the value by amission, which allows eJ. early replacement of the cassette by a properly instructed user or by a provider of the health care. If the cassette of. Drug 14 is changed with less than 6 ml, the counter will be readjusted again to 50 ml, -assuming. a replacement or a new normal cassette. The user should be instructed not to remove the cassette until the value of the dose left on the screen 16 indicates one or zero dose, and only install full bottles of supply. of medication. 6. Compliance Memory The assortment ^ 10 preferably includes sufficient non-volatile memory in. RAM 2.0 to maintain a compliance history of up to approximately nine hundred and fifty doses that are stocked. Two doses per day result in up to fifteen months of compliance history, three doses- per day result in up to ten months of compliance history .. .Each. dose as registered as a temporary event with a resolution of ten minutes and a maximum time lapse of fifteen months, based on the. internal clock as adjusted by the health care provider, by the patient or by another user via a personal computer and interconnection ßn. series 26, the effective stored values should be. interpreted by the computer hardware of the personal computer after the discharge, to establish the effective days and months. In addition to storing the time of each dose filled, the compliance memory also stores the dose sizes. To save memory, it only stores a new dose size in the compliance memory when the health care proponent, the patient or another user changes it. The stored values are in the range of one to fifty, corresponding to 10 mg to 500 mg. When changing the dose size. the equivalent of a temporary record is used, reducing the maximum number of doses recorded by one for each change. Even in unusual cases where the dose changes frequently, this should not have an impact on the usefulness of the product. Optionally, the compliance mempria could also store the time of each change of supply of, medication to confirm the. correct use of each supply. If the compliance file has thirty or fewer memories available, the "service" icon 106 shown in Figure 8 will flash on the screen and an audible alarm will sound after each dose is taken. 7. Qualification of Cμmpiimi.e tp] 1 supplier 10 also maintains a history of the numbers of doses - taken every day for, a period of qualification of compliance; for example, thirty days. From that history, it computes a percentage of compliance with the prescribed number of doses versus the effective number. With reference to Figure 8, this value is then displayed visually as a calification-.10.8 .in. the observation segment 48c of screen 16, for the monitprep p periodic check. The compliance rating is updated as a function of time and dosage, and changes if the dose does not. occurs at the specified times or at the specified doses. The values are in increments of 1%, so that the qualification steps include 0% up to 100%. Note that this information is kept in a separate proportion of the RAM -20. Compliance memory for computing purposes, but it can also be cleared independently of compliance compliance. As a result, a patient's rating can continue uninterrupted even after the upward loading of compliance data. In order to determine the compliance rating, when a dose is taken, the "dose a day" count is increased, up to a maximum of four doses per day. At 1 A, M.- of every day, the dose count is adjusted to zero. Where the compliance qualification. is computed _sob »a three-day run period, the last thirty days of the count are added together and counted-the total number of days. If the total number of days counted is less than c: j.nco, the account is forced to five, -so that a 100% compliance score is not met ... up to five days of medication. The compliance score is then computed according to: Qualification = (sum of dose) / dose per day * account -total of the day) and rounded up to the nearest 1% increase.

As can be seen, the compliance rating is a critical indicator that the patient, the health care provider or other responsible person to periodically verify the treatment, can use to determine if it is - Adequate therapy with the drug takes place. 8. General Memory The dispenser 1.0 also includes the RAM memory 20 which allows the programming of the name or identification of the. patient. (30 characters)., the name of. the pharmacy or identification (30 characters), the serial number of the device (1.0 characters), the last date and time when the unit was programmed, the. number of doses per day prescribed, and the presets of the time interval (useful when prescribed 3 6 4 doses per day). 9. -Internal Watches The pump 10 maintains a real-time clock that is _adjusted by means of a personal computer and the serial interconnection 26. This does not consider date or months or - changes of hour. This simply counts every ten minutes at a maximum of 65,530 or 10,922 hours, or 455 days. The time of day for him. day zero..e.s registered after programming. This is used to establish when the day change occurs to readjust the medication marks. 104 of the "daily doses". When the atos are uploaded to a personal computer via the interconnection of the stamp 26, the personal computer receives the value of the current real-time clock from the dispenser 10 and computes the actual days and time for this real-time clock value in relation to at the time read and date from inside the personal computer. To set the time and effective date of a dose _partic.Ul.ar, the time e dose is subtracted from the current real-time clock value to determine how much time has elapsed since the dose- The elapsed time is then used to- decide . a date d.e. effective calendar and time within the personal computer. This ten-minute clock is kept in memory, non-volatile, so that a loss of battery power due to a fall, go.lpe or a change of the battery by the patient, will not result in a readjustment. complete clock or confusion within the compliance data. Optionally, when the clock is at a predetermined number of days, such as three hundred and sixty-five days or more since it was made. The service by the health care provider, the service icon 106 will flash on the screen and an audible alarm will sound after each dose is taken.

. Sleeping mode and. Temporary Suspension The spout 10 enters a sleep mode when it is not in. Use between doses, to save battery power. During that time, screen 16 is blank and the only internal activity is clock maintenance. By pressing either the alarm / increment key 22 or the key 24. of screen / dose, or when removing the medicine cassette 14, this will awaken the .1 .supressor and activate, the screen 1-6. Also, one hour before the time for dosing, the dispenser 10 will automatically wake up and activate the display 16. The dispenser 10 will go back to the sleep mode after two minutes of non-activity, called the period of "temporary suspension" of sleep. 11. Programming and Uploading of Data The health care provider could generally run a software program on an external personal computer to communicate with the supplier 10 to schedule and read the compliance history. To enter the communications mode, the alarm / increment key 22 is held down for three seconds until the screen 16 goes blank. This indicates that the dispenser 10 is ready to talk to the personal computer. The software on the personal computer is then cprridp (or the correct function activated within the software that is already running). The personal computer then transmits various commands to the supplier 10 and establishes the communications. When all communications are finished, pressing the assortment button 42 (which, in turn activates the assortment switch 26) causes the dispenser 10 to exit communication mode and return to normal operation. Preferably, the communication mode operates with the following security devices; a) the communication mode can not be introduced if the dispenser 10 is in the process of adjusting a dose or dispensing a dose. b) the alarm / increment key 22 does not need to be held down during communications. c) The watches. interns are suspended during the., communications mode. The personal computer always .actuates. cpmp the maest.rp and issue commands either to read data from or write data to the supplier 10, a full data transfer will take approximately 4 to 20 seconds, depending on the amount of data transferred. Simply scheduling the dispenser 10 s almost instantaneous • since few data are transferred. For compatibility, a data rate of 24.0.O.batidlos- is used. 12. Command Group Programming The control microprocessor 12 includes, the programming that will carry out in general the operations of: a) The programming of the name and identification, (ID) of the patient. b) Programming the name of the drug .and identification (ID). c) Programming the serial number (only used in production). d) Resetting the real time clock to the current time, day zero (10 minute clock). e) Programming the size of the dose. f Y. Programming of doses per day (one to four). g) Programming of the dose intervals (4 digit values of two hours, example: 04, 04, 04, 12). 'h) Resetting the battery timer (new battery installed). i) Clearing the compliance history memory. j) Clearance of compliance qualification memory (30-day histogram data). k) Reading of data: this operation includes the reading of the compliance memory of all the doses taken since the compliance memory was recently cleared (the time for each dose and all lps sizes of .dosis, used), the names and identities of the patient and the drug, the serial number of the device, the chronometer of the life of. the battery, the current real-time clock, and the time value when the unit was last programmed. All data is uploaded at one time, allowing the personal computer to be used to further manipulate the data to be visually displayed and / or printed. 13. Battery change stopwatch To save energy and cost, the dispenser 10 does not preferably use a batch detector. Of battery. Instead, it detects when the battery is removed and starts a stopwatch when the new battery is installed. After a preset period of time - for example, six months or after a certain number of assortments from a battery change, the seryigip icon. 10.6 (Figure 8). Will illuminate at any time the unit is awake. Note that this stopwatch • is independent of the clock. This stopwatch value can also be s.er. read, by μnacomputer staff on the series 26 interconnection, so that the health care provider can observe it., As a routine, the health care provider should change the batteries regularly. if the battery timer has not been interrupted, to ensure reliable operation. 14. "Replacement" of the Drug Cartridge The empty medication cartridge 14 is removed from the dispenser 10 by holding two side latches 74 (Figure 6) in the lower portion of the dispenser 10 by removing the complete medicament cartridge 14. This includes the bottle 76 of liquid medicament and the disposable fluid path components To load a new cassette of medicament 14 into the dispenser 10., the cassette assembly is inserted into the dispenser 10 until the two side latch assemblies 72 , 74 are attached.The medicament cassette .14 is assembled using a standard drug bottle and a disposable fluid path assembly.The medicament cassette is automatically prepared during the first dose, after it is installed, eliminating any pre-treatment by the health care provider or the patient The accuracy, -, of the action of preparation or preparation can introduce a small degree. error in the smallest doses, and some compensation may be necessary. Note that yes, the drug vial 14 is removed and then reinstalled, the first dose administered will be overdosed by the dressing volume, which is in the range, from about 0.1 ml to 0.2 ml.

. Possible Solved Problems .. for the Invention Table 1 lists • various problems or dangers associated with medication taking, and indicates how the present invention overcomes or avoids these problems. Preferably, a user's manual with the invention is provided, which explains the solution provided by the dispenser 10. The "level of interest" column shown in Table 1 corresponds to the definitions of the FDA regarding the hazard. otential- performed on n patient., all cases, the mitigated level of interest is reduced to LESS INTEREST, causing little or no harm to the patient. Accordingly, it will be appreciated that this invention provides a liquid medication dispenser that alerts patients of the correct time intervals for taking liquid medications, which maintains the ras.trep of and displays the number of liquid medications. _ dose of liquid medication taken, which measures, in a fast, consistent and accurate manner and similarly delivers the doses of liquid medication in a user-friendly manner, and which records the date, time and dose level , so that compliance with the treatment can be reviewed by the patient and / or the health care provider who oversees the treatment. The invention is particularly suited for immunosuppressive therapy in patients with transplantation. The use of an immunosuppressant drug such as cyclosporin, tacrolimus, microphenolate mpfetil, mycophenolic acid, rapamycin or azathioprine, steroids, leflumomide, on a daily basis (e.g., once, twice or four times) is essential to overcoming the transplant. times a day) at the appropriate dose. Insufficient dosing can result in acute rejection of the graft and loss of the graft. Excessive dosing may result in nephrotoxicity, liver tone, infectious cancer or neurotoxicity. Patients need specific education and periodic monitoring or verification; These typically have three to ten medications per day to be used on a chronic basis. The measurement of compliance, or lack of compliance, can help health care providers better direct their education and periodic verification efforts toward certain patients. Although the foregoing description contains many specificities, these should not be considered as limiting the scope of the invention, but merely provide illustrations of some of the presently preferred embodiments of this invention. Thus, the scope of this invention should be determined by the appended claims and their legal equivalents. Furthermore, those skilled in the art will appreciate that various forms of circuitry can be used for inception, and that the schematic diagram shown in Figure 2 is but a single modality that could be extended. . For example, the circuit elements could be replaced with P-logical digital equivalents. Further, it will be appreciated that the control microprocessor 12 and its associated and related programming components provide the means to carry out synchronization on the registration and the dose tracking functions, and the related computations described above, as well as the cpntro.l of the drug cassette 14 and communications with external devices such as a personal computer. Also, the sequences. and programming steps for the control processor 12 may vary without departing from the scope of the invention. Those skilled in the art will appreciate that conventional programming techniques may be employed to implement the functions described herein with respect to remotely programming and interrogating the dispenser 10 with an external personal computer. J51 design and coding of such computer hardware to carry out those functions, could be easily developed by a person having ordinary experience in the art and is not described herein.

Size of dose, Dose size - Effective is always wrong shown before assortment. . The patient is programmed to be instructed to observe the dose size of the patient. The patient is instructed about the use of the device, the device assortment, when it is delivered, and the complete instruction manual contains the instructions for the patient. Include an arrow (not shown) indicating the assortment site on the bottom to ensure that the medication is emptied into the vessel.

Bßm a- The pump, disposable and a-homba of the motor- -disposable IIT + STH- designed to aerate, with the adequate condition that the fluid path desired to be coupled to the cam -is completely inserted. The endowment of the engine. Computer logic verifies the proper insertion -of the supply -of-medication and -BO will -supply and cause an alarm if it is not inserted properly. The supply of the computer software keeps a medication record of the amount of medication empty during the left in the medication cache and not the assortment. it will supply, and-it will cause an alarm if- exists. insufficient solution in the supply. Fluid path no The dispenser automatically arranges track 4 « It should be noted that in relation to this date, the best method known to the applicant for carrying out the aforementioned invention is that which is clear from the present description of the invention.

Claims (29)

RE IV.INDICATIONS Having described the invention as above, the content of the following claims is claimed as property:

1. An apparatus for therapeutic drug therapy, characterized by comprising: a) a means for delivering a plurality of oral doses of a therapeutic liquid drug from a medication container; and b) the means for recording the doses of the liquid therapeutic drug assortment.

2. An apparatus according to claim 1, further characterized. This includes the means to record the times in which the doses are supplied. •

3. An apparatus according to claim 2, characterized in that. it further comprises the means for comparing the doses of liquid therapeutic drug assorted, and the times at which the doses are dispensed, with the specified doses and times specified for supplying the liquid therapeutic drug, and determining a compliance rating as a function of said comparison.

4. An apparatus of. according to claim 3, characterized in that it also comprises the means • to periodically verify the compliance rating.

5. An apparatus for therapeutic therapy, characterized in that it comprises: a) the means for supplying. plurality of oral doses of a liquid therapeutic drug from a medication container; and b) the means to record the times in which the doses are supplied.

6. An apparatus according to claim 5, further characterized in that it comprises the means for recording, the doses of the liquid therapeutic drug assortment.

7. An apparatus according to claim 6, characterized in that j further comprises the means for comparing the doses of liquid therapeutic drug assorted, and the times at which the doses are supplied, with the doses. specified and the times specified for supplying the liquid therapeutic drug, and determining a compliance rating as a function of said comparison.

8. An apparatus of. according to claim 7, characterized in that it also comprises the means for verifying. periodically the compliance rating.

9. A parato to supply liquid medication, characterized in that it comprises: a) the means to supply a plurality of doses of liquid medication from a medication container; and b) the means to record the doses of liquid medication assortment; and c) the means to record the times when the liquid medication drops are stocked.

10. An apparatus according to claim 9, characterized in that it also comprises the means for comparing the. dose of liquid medicaments assorted, and the times when the doses are filled, with the specified doses and the specified times to supply the liquid medication, and determining a compliance rating as a function of said comparison. 11 ^.

An "apparatus according to claim 10, characterized in that it also comprises the means for periodically verifying the compliance rating.

1. 2. An apparatus according to claim 9, characterized in that the liquid medicament contains a hydrophobic drug.

13. An apparatus, according to claim 9, characterized in that the liquid medicament contains cyclosporin.

14. An apparatus according to claim 9, characterized in that the liquid medicament contains an immunosuppressant drug.

15. An apparatus according to claim 9, further characterized in that it comprises the means for alerting. to a user, that a dose of liquid medication must be • supplied.

16. . An apparatus according to claim 9, characterized in that it further comprises the means for determining the number -remanent dose in the medication container. -

17. An apparatus according to claim 16, characterized in that it further comprises means for visually displaying the remaining number of doses.

18. An apparatus according to claim 9, characterized in that it further comprises the chronometer means for preventing a dose of liquid medicament from being dispensed before a specified period of time after a previous dose has been dispensed.

19. An apparatus according to claim 18, further characterized in that it comprises means for interrupting the chronometer means.

20. , A device for supplying liquid medication, characterized in that it comprises: a) éj. means to supply a plurality of doses of liquid medication from a container of medication; b) the means to record the doses of liquid medication assortment; c) the medip to find the times in which the doses of liquid medication are supplied; d) the means p, to compare the doses of the liquid therapeutic drug assortment and the times in which the doses are supplied with. the specified dosages and times specified for supplying the liquid therapeutic drug and determining a compliance rating as a function of said comparison; and e) the company to periodically verify the compliance rating.

21. Apparatus according to claim 20, characterized in that the liquid medicament contains a hydrophobic drug.

22. An apparatus according to claim 20, wherein the liquid medicament contains cyclosporin.

23. An apparatus according to claim. 20, characterized in that the medicament _ liquid contains. an immunosuppressant drug.

24. and an apparatus according to claim 20, characterized in that it further comprises the medip to alert a user that a dose of the liquid medicament must be dispensed.

25. An apparatus according to claim. 20, characterized in that it further comprises means for determining the remaining number of doses in the medication container.

26. An apparatus in accordance with. Claim 25, characterized in that it also comprises the means for displaying the remaining number of doses.

27. An ap r to according to claim 20, characterized in that it further comprises the medip of crpnqmeiro- p r prevent that ss a dose of liquid medication is supplied before a specified period of time after a previous dose has been dispensed.

28. An apparatus according to claim 27, further characterized in that it comprises means for interrupting the chronometer means.

29. An apparatus for dispensing the liquid liquid, characterized in that it comprises: a) the means for supplying a plurality of doses of liquid medicament from a container of medicament; b) The means to visually show. the remaining number of doses in the medication container; c) the medip to alert a user, that a dose of liquid medication must be dispensed; d) e medip for preyeni? a liquid drug dpsis is dispensed before a specified period of time after a specified dose has been dispensed; e) the means for recording the liquid medication dpsis dispensed; f) the means to record the times. and the doses in which the liquid medication is dispensed; g) the means to compare the doses of liquid therapeutic drug assortment and the times when the doses are given / with the specified doses y. the times specified for supplying the liquid therapeutic drug and determining a compliance rating as a function of said comparison; and h). the means to - communicate the compliance rating to a user.