Medication compliance monitoring device having conductive traces upon a frangible backing of a medication compartment

• US 4,616,316 A
• Filed: 01/13/1983
• Issued: 10/07/1986
• Est. Priority Date: 07/01/1982
• Status: Expired due to Fees

• Current Assignee: Medical Technology Systems Inc (Omnicell Inc)
• Original Assignee: The United States of America As Represented By The Secretary of Agriculture
• Inventors: Gard, Michael F., Hanpeter, John A., Eisen, Seth A.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Jablon, Clark A.
• Application Number:
  US06/458,312
• Time in Patent Office: 1,363 Days
• Field of Search: 364/705, 364/413, 364/479, 364/569, 206/531, 206/532, 206/534, 235/98 A, 235/98 B, 340/303, 221/2, 221/3, 221/4, 221/5, 221/8, 221/15, 221/25, 221/26, 221/302, 339/80
• US Class Current: 221/2
• CPC Class Codes: A61J 1/035 Blister-type containers blisters in general B65D75/36
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61J 7/0481 working on a schedule basis

Abstract

A medication compliance monitoring system consisting of a blister pack having an array of plastic blisters defining compartments for medication, with a frangible non-conductive backing sheet having conductive traces behind the compartments which are respectively ruptured when the medication doses are removed. The blister pack is detachably connected to an electronic memory circuit via a multi-terminal male connector tab on the backing sheet, wired to the conductive traces, and a corresponding female connector with terminals wired to the electronic memory circuit. The electronic memory circuit addresses each individual trace periodically at a constant time interval over a predetermined extended period of time to determine if it is intact. The electronic memory circuit detects the ruptures and stores the time data thereof over said extended period of time. During the patient'"'"'s follow-up visit a microcomputer is employed to retrieve the dose-removal-time data from the memory circuit; it processes the data and provides a display of the compliance information. A socket adapter is used to alternately configure the electronic memory circuit for data acquisition and extraction. The socket adapter is in the form of a multiple-pin jumper plug engageable in a multi-contact socket connected to the memory circuit. Insertion of the plug configures the memory circuit for data acquisition. Removal of the plug configures the memory circuit for data retrieval and processing by the microcomputer. In a typical embodiment there are 42 blisters whose associated conductive traces are addressed every 15 minutes over an extended time period which may be as much as 85 days.

Claims

1. A medication compliance monitoring device, comprising:

a medication package including

an array of medication compartments each being designed to carry a unit close of medication therein and each being yieldable for medication removal,

a frangible backing sheet closing all of of said medication compartments such that medication can be removed from each said compartment by pushing the yieldable compartments to force the medication through the frangible backing sheet by rupturing the backing sheet adjacent the compartment being pushed; and

an electronic monitoring circuit including

a plurality of conductive traces disposed on said backing sheet, a unique trace being disposed adjacent each said compartment such that the rupture of said frangible sheet during removal of a unit dose of medication from a compartment will cause rupture of one of said conductive traces,

detection means for addressing each said unique trace periodically at a constant predetermined time interval over a predetermined extended period of time and detecting whether each such trace is ruptured or intact,

memory means for storing the time that the rupture of each unique trace is first detected by said detection means, and

connecting means for permitting said memory means to be connected to a microcomputer, whereby said microcomputer can extract data from said memory means for processing and display.

2. The medication compliance monitoring device of claim 1, wherein said array of medication compartments comprises a front sheet of yieldable material formed with an array of blisters defining the respective medication compartments.

3. The medication compliance monitoring device of claim 2, and wherein said blisters are arranged in a plurality of rows columns.

4. The medication compliance monitoring device of claim 2, wherein said blisters are arranged in a plurality of rows and columns defining said array and wherein the package is foldable on at least one transverse fold line of said array.

5. The medication compliance monitoring device of claim 2, and wherein said blisters define a substantially rectangular array.

6. The medication compliance monitoring device of claim 1, wherein each said unique conductive trace on the frangible backing sheet extends substantially in a saw-tooth pattern across a medication compartment.

7. The medication compliance monitoring device of claim 1, wherein said backing sheet includes a connector tab provided wih respective terminals connected to said conductive traces.

8. The medication compliance monitoring device of claim 1, wherein said array of medication compartments comprises an elongated front sheet of yieldable material formed with an array of blisters forming the compartments and comprising rows and columns of said compartments, said frangible backing sheet being substantially coextensive with and being secured to said front sheet, said conductive traces extending substantially in saw-tooth patterns across the compartments.

9. The medication compliance monitoring device of claim 8, wherein the package is transversely foldable to define a plurality of panels, and wherein said backing sheet is provided with a connector tab extending longitudinally along one of said panels and having respective terminals connected to said conductive traces.

10. The medication compliance monitoring device of claim 1, further including manually operable control means to alternately configure said electronic monitoring circuit for data acquisition and for data extraction.

11. The medication compliance monitoring device of claim 1, wherein said conductive traces on said frangible backing sheet extend substantially diagonally across the medication compartments.

12. The medication compliance monitoring device of claim 1, further including a protective housing, and an electronic circuit board disposed within said housing, said detecting means and memory means being disposed on said circuit board, wherein said circuit board includes cooperating multiconductor detachable connector means for electrically connecting said detecting means and memory means with said conductive traces, and wherein said medication package is receivable within said protective housing.

13. The medication compliance monitoring device of claim 1, wherein said backing sheet includes a connector tab provided with respective male terminals connected to said conductive traces, and wherein said cooperating connecting means comprise a female multi-terminal connector on said circuit board, said male connector tab being grippingly but detachably receivable in said female multi-termal connector.

14. The medication compliance monitoring device of claim 13, wherein said array of medication compartments comprises an elongated front sheet of yieldable material formed with an array of blisters forming the compartments, said frangible backing sheet being substantially coextensive with and being secured to said front sheet, said traces extending across the blisters, and wherein said package includes at least one panel and said male connector tab is located at the side margin of said panel.

15. The medication compliance monitoring device of claim 13, wherein said array of medication compartments comprises an elongated front sheet of yieldable material formed with an array of blisters forming the compartments, said frangible backing sheet being substantially coextensive with and being secured to said front sheet, said traces extending across the blisters, and wherein said package is transversely foldable to define a plurality of panels and is receivable in said protective housing in the folded condition, said male connector tab being located at the side margin of one of said panels.

16. The medication compliance monitoring device of claim 15, and wherein said package is transversely foldable at two locations to define three respective panels, said male connector tab being located at the side margin of the central panel.

17. The medication compliance monitoring device of claim 1 having a size and weight suitable for personal use.

18. A method of monitoring medication compliance, comprising the steps of:

supplying to a patient whose medication compliance is to be monitored a medication package having an array of medication compartments which are yieldable for medication removal, a plurality of said compartments having a medication in unit dosage form therein, the package further including a frangible backing sheet closing all of of said medication compartments such that medication can be removed from each said compartment by pushing the yieldable compartments to force the medication through the frangible backing sheet by rupturing the backing sheet adjacent the compartment being pushed; and

a plurality of conductive traces disposed on said backing sheet, a unique trace being disposed adjacent each said compartment such that the rupture of said frangible sheet during removal of a unit dose of medication from a compartment will cause rupture of one of said conductive traces;

addressing each individual trace periodically at a constant predetermined time interval over a predetermined extended period of time to detect whether each such trace is intact or ruptured;

storing the time that the rupture of each unique trace is first detected; and

subsequently retrieving the stored time data comprising the respective detected times of rupture of the addressed individual traces.