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U.S. Patent Oct 7,1986 Sheet 5 of 6 4,616,316
MEDICATION COMPLIANCE MONITORING DEVICE HAVING CONDUCTIVE TRACES UPON A FRANGIBLE BACKING OF A MEDICATION COMPARTMENT
The present application is a continuation-in-part of the patent application of John A. Hanpeter, Jr., Seth A. Eisen and Michael F. Gard, Ser. No. 394,432, filed July 1, 1982, and now abandoned, entitled "Medication Compliance Monitoring Device", the contents of which are incorporated herein by reference.
FIELD OF THE INVENTION
This invention relates to medication dispensers, and more particularly to a device for providing detailed information on patient medication compliance.
BACKGROUND OF THE INVENTION
Poor compliance with the physician-prescribed medication regimen is a major cause of disease-related morbidity and mortality. For example, hypertension, which affects 60 million Americans, is a significant risk factor for stroke, heart and kidney diseases. Research has demonstrated that hypertension can be controlled in the vast majority of patients with currently available medications if patients adhere to the prescribed regimen at least 80% of the time. Unfortunately, many patients are not compliant with their medications and therefore are at increased risk of complicating illnesses. The lack of a satisfactory method of measuring medication compliance has hindered the assessment of attempts to improve compliance as well as research which might increase our understanding of poor compliance.
Various previously proposed devices for testing compliance of patients with prescribed medication regimens have proven to be unsatisfactory in that they are relatively cumbersome, are not accurate, and do not adequately cover the extended time spans for which many prescribed dosing regimens must be maintained.
In general, the prior art includes a number of mechanical devices for indicating the timed removal of pills from various holders or dispensers. For example, the Fortenberry U.S. Pat. No. 3,410,450 discloses a sanitary pill dispenser with an indicator dial to indicate release of each successive pill. Also see the Bender U.S. Pat. No. 3,871,551 which shows a pill dispenser with a pillactuated time readout. Barton et al U.S. Pat. No. 3,402,850 discloses a tablet dispenser with a day-indicating schedule.
The patent to Gervais U.S. Pat. No. 3,344,951 shows an injection pill dispenser which incorporates a mechanical device for recording of times of pill removal under prescribed conditions. The Pilot U.S. Pat. No. 3,332,575 shows another dispenser with an indicating means, which indicator gives the day each pill is dispensed. Harman et al U.S. Pat. No. 3,688,945 shows another mechanical tablet dispenser, for contraceptive pills, with a time indicator. The Gayle U.S. Pat. No. 3,687,336 shows another mechanical device which ejects pills in synchronization with day indicating means. And Huck U.S. Pat. No. 3,511,409 shows another mechanical dispenser with a day indicator for pill usage.
Accordingly, there is a definite need for an improved device for measuring the compliance of patients with physician-prescribed medication regimens.
SUMMARY OF THE INVENTION
A medication compliance monitoring system according to the present invention has three functional components: the blister pack, the electronic memory circuit, and a microcomputer data processor. In a typical embodiment, the blister pack consists of a sheet of plastic into which 42 blisters are formed, and a sheet of backing material. The patient's tablets or capsules are loaded into the blisters and the backing material is sealed to the blister sheet. A matrix of conductive traces is incorporated into the backing material such that a unique trace is positioned behind each blister in the pack. When the medication dose is pressed through the backing material, the conductive trace behind that dose is broken. The electronic memory circuit addresses each individual trace every 15 minutes to determine if it is intact. The time of removal, resolved into 15 minute intervals with less than 0.01% error, is stored in memory for each individual dose over an 85 day period. A protective plastic case (50 mm X170 mmX30 mm) contains both the memory circuit and the fold-out blister pack. The total weight is approximately 100 grams. Thus, the device is small and lightweight and thus of a size and weight suitble for personal use and can be conveniently carried by the patient in his or her pocket, briefcase, or handbag.
In practice, the blister pack is loaded with the appropriate medication and connected to the memory circuit in the case, the memory circuit is initialized, and the device is issued to the patient. The patient carries it with him or her and returns it to the physician on his or her next visit. During the patient's follow-up visit, the memory circuit is interfaced to the microcomputer data processor. This system acquires the raw time data from the memory circuit, stores the raw data on a diskette, processes the data, and provides the medication compliance data to the physician in a graphically formatted printout. The physician utilizes the data to analyze the patterns of the patient's non-compliance and then works with the patient to develop a more acceptable medication regimen.
Accordingly, objects of the invention are to provide a novel and improved patient medication compliance device which overcomes the deficiencies and disadvantages of the previously known dosage monitoring systems, and to provide for improved patient medication compliance and/or monitoring.
A further object of the invention is to provide an improved medication compliance monitoring device which is compact in size, light in weight, accurately records the time of removal of medication doses over a dosage regimen which may extend for a relatively long period of time, addresses the dosage locations at uniformly regular, relatively short intervals of the order of every 15 minutes, to determine whether the medication doses originally placed therein are intact, and which stores the respective times of removal of the doses in a memory for subsequent analysis by medical personnel to determine the pattern of medication compliance of the patient.
A still further object of the invention is to provide an improved medication compliance monitoring device which may be furnished to a patient by a physician and which employs a,blister pack loaded with appropriate medication in the form of tablets, capsules, or the like, arranged in respective compartments, each compartment being provided in its back wall with a conductive
trace which is broken when the associated medication unit is removed and which is repetitively tested for integrity by an electronic memory circuit in the device, the memory circuit storing data corresponding to the detection of the broken traces, which is time data giving 5 the time of removal of the respective medication doses, the stored data being retrievable when the patient returns the device to the physician at his next visit, so that the pattern of the patient's medication compliance can be readily analyzed by the physician by interfacing the '° memory circuit with a microcomputer data processor.
A still further object of the invention is to provide an improved medication compliance monitoring device including a blister pack carrying medication arranged in compartments with conductive traces which are broken 15 when the associated medication doses are removed, and which are monitored by an electronic memory circuit, the memory circuit being contained in a compact carrying case and the blister pack being normally folded so as to be housed in the case along with the electronic monitoring and memory circuit, the blister pack being detachably connected to the electronic memory circuit but being detachable therefrom, by disengageable connector means so that the case and electronic circuit can ^ be reused with a new blister pack after a first pack has been employed for a medication regimen.
BRIEF DESCRIPTION OF THE DRAWINGS
Further objects and advantages of the invention will 3Q become apparent from the following description and claims, and from the accompanying drawings, wherein:
FIG. 1 is a top plan view of a blister pack employed in the medication compliance monitoring system according to the present invention, shown in unfolded 35 condition.
FIG. 2 is an enlarged end elevational view taken substantially on line 2—2 of FIG. 1.
FIG. 3 is a partly diagrammatic top plan view of the backing sheet employed in the blister pack of FIG. 1. 40
FIG. 4 is a top plan view of an open medication compliance monitoring device according to the present invention, including the blister pack of FIG. 1, the blister pack being shown in unfolded condition allowing a patient to remove a medication dose. 45
FIG. 5 is a transverse vertical cross-sectional view taken substantially on line 5—5 of FIG. 4.
FIG. 6 is a functional block diagram of the electronic memory circuitry employed in a medication compliance monitoring device according to the present invention. 50
FIGS. 7A, 7B and 7C are segmental detailed wiring diagrams which, when placed side-by-side, substantially form the monitoring memory circuitry functionally represented in FIG. 6.
FIG. 8 diagrammatically shows an adapter for condi- 55 tioning the monitoring memory circuitry for use by a patient.
DETAILED DESCRIPTION OF A PREFERRED
Referring to the drawings, and more particularly to FIGS. 1 to 5, 11 generally designates a blister pack forming part of the present invention. The blister pack
11 is that portion of the device which contains the patient medication. The blister pack 11 comprises a sheet 65
12 of plastic material in which an array of blisters 13 is formed, and a sheet 14 of insulating backing material. The patient medication is loaded into the blisters 13 and
the backing sheet 14 is sealed to the blister sheet 12 by a layer of suitable adhesive.
In the illustrated specific embodiment, the blister pack 11 of FIGS. 1 to 5 contains 42 blisters 13 in an array of 3 rows of 14 blisters on 3 panels that fold backto-back on respective transverse fold lines 15 and 16. Each blister 13 is generally oval-shaped, with a major axis of 22 mm, a minor axis of 13.5 mm, and a depth of 9 mm. The blister pack 11 is connected to the electronic memory board, designated generally at 19 in FIGS. 4 and 5, via a multiple-contact, flexible connector tab 17 formed on sheet 14 and extending along the center panel of the blister pack.
The backing sheet 14 used to seal the blisters 13 is of a special nature. Said sheet 14 is formed of thin frangible insulating material. A matrix of sawtooth-shaped conductive traces 18 is incorporated into the backing material, arranged so that a unique conductive trace 18 is positioned behind each blister 13 in the blister pack 11. While the dose is still present in a blister 13, the associated trace 18 behind that blister remains intact. When the dose is pressed through the backing material however, the trace 18 is broken. The electronic memory device 19 addresses and tests each individual trace periodically to determine whether or not the trace is intact.
The electronic memory device 19 is that portion of the apparatus that records the elapsed-time interval during which the conductive trace 18 behind each blister 13 is broken. The electronic circuitry is enclosed in a suitably formed rectangular plastic case 20 with a longitudinally hinged top cover 21, as shown in FIGS. 4 and 5. In the described specific embodiment, the case is 50 mm wide, 170 mm long, and 30 mm deep. The case 20 is detachably secured to the blister pack 11 by the interlocking frictional engagement of the tab 17 in a multi-contact female connector sleeve S3 carried by the circuit board of the electronic package 19 adjacent the longitudinal side wall 24 of the case 20 opposite the hinge of cover 21, as shown in FIG. 5. The contacts of connector sleeve S3 make contact with the respective contact terminals 23 associated with the conductive traces 18 and connects them to the electronic memory package 19.
The electronic memory circuitry keeps account of the elapsed time (from initialization) and at 15 minute intervals, evaluates the integrity of the conductive trace 18 behind each blister 13 in the blister pack. A single 12-bit memory word is assigned to each blister and stores the elapsed time data for that blister. While the conductive trace 18 behind the blister is intact, the circuitry updates the elapsed time information in the corresponding memory location at the end of each 15 minute interval. Once the trace 18 is broken, the circuitry no longer updates the elapsed time information. Thus, when the device is retrieved from the patient, the time information in each memory location represents the elapsed time interval during which the trace 18 was broken.
The electronic memory circuitry can be separated into eight functional blocks, as illustrated in FIG. 6. The Time Base 26 provides crystal-controlled timing signals to the other functional blocks, namely, an 18.641 KHz Fast Clock and a 4-pulse-per-hour timing signal. The Elapsed Time Generator 27 counts the pulses from the Time Base 26, and provides 12-bit binary elapsed time information to the Memory 28.
The Memory 28 provides a single 12-bit memory word for each blister 13 in the blister pack. If the dose