Apparatus and method for optimizing treatment using medication compliance patterns and glucose sensor

• US 10,572,627 B2
• Filed: 02/17/2016
• Issued: 02/25/2020
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: ID Therapeutics LLC
• Original Assignee: ID Therapeutics LLC
• Inventors: Mayer, Steven L., Kravitz, David C., Mayer, Tracey H.
• Primary Examiner(s): Kanaan, Maroun P
• Application Number:
  US15/045,854
• Publication Number:
  US 20160162659A1
• Time in Patent Office: 1,469 Days
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 7/0409 with timers
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61J 7/0436 resulting from removing a drug from, or opening, a container
• CPC Class Codes: A61J 7/0445 for preventing drug dispensing during a predetermined time period
• CPC Class Codes: A61J 7/0481 working on a schedule basis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Methods and apparatus monitor medication usage data for one patient or a population of patients, which can be processed to determine compliance patterns. Such methods and systems can associate, analyze, organize and present medication usage data, compliance patterns, and correlations between compliance patterns and outcomes data for electronic analysis or analysis by a caretaker. Such methods and apparatus permit analysis of compliance patterns to enable, for example, establishment or adjustment of safe and effective treatment regimens, and may include feedback systems for ensuring authenticity of medication and/or effects of medication on a patient. Such methods and apparatus also permit detection of medication in a biological sample of the patient through a medication monitor having a detection device, such as a skin-prick device, and a glucose sensor that can detect a target agent in the biological sample.

Claims

1. A medication monitor comprising:

a housing configured to contain medication;

a detection device integrally formed into the housing, the detection device having a sample collection device and a target agent sensor for detecting a target agent in a biological sample from a user, wherein

the target agent sensor includes a plurality of sensors, where each sensor of the plurality of sensors comprises;

a solid support to which is attached a recognition molecule that specifically binds to the target agent in the presence of the target agent but not significantly to other agents,

a substance that can be enzymatically converted to glucose, and

an enzyme that can catalyze the conversion of the substance to glucose in the presence of the target agent, wherein

each sensor of the plurality of sensors being configured to detect a different target agent, and

at least one sensor of the plurality of sensors is configured to detect Tacrolimus or a metabolite thereof;

a processor configured to correlate the user'"'"'s pattern of compliance with medication data and generate an adjusted treatment regimen upon identifying, based on an amount of glucose sensed, a pattern of misses in an initial treatment regimen; and

a communication port configured to communicate the medication data to a data network.

2. The medication monitor according to claim 1, wherein

the housing includes a section for containing medication packaging, the housing defining an opening to accommodate insertion and removal of the medication packaging.

3. The medication monitor according to claim 2, further comprising:

a lid that opens to removably cover the opening;

a medication sensor that is configured to sense identity of the medication; and

a removal sensor that senses medication or medication packaging removal or device opening, wherein

the processor also produces medication data based on the sensed removal.

4. The medication monitor according to claim 1, wherein

the sample collection device is a skin-prick device.

5. The medication monitor of claim 4, wherein

the medication sensor is configured to sense an indicium of origin of manufacture of the medication to verify authenticity of the medication.

6. The medication monitor of claim 5, wherein

the indicium of origin is provided by an information source associated with a pre-filled medication cartridge that is insertable into said opening.

7. The medication monitor of claim 6, wherein the housing includes a plurality of housings for containing a plurality of pre-filled medication cartridges.

8. The medication monitor of claim 6, wherein

the information source is at least one member selected from the group consisting of an RFID chip, a barcode, and a shape of the cartridge.

9. The medication monitor according to claim 1, wherein the enzyme is attached to a Tacrolimus analogue molecule or a Tacrolimus metabolite analogue molecule that competes less strongly than Tacrolimus or the metabolite thereof for binding to the recognition molecule.

10. The medication monitor according to claim 1, wherein the enzyme is attached to a molecule that binds to Tacrolimus or a metabolite thereof that is bound to the recognition molecule.

11. The medication monitor of claim 1, wherein

the processor is configured to compare the amount of glucose sensed with a baseline glucose level and quantitatively determine an amount of the target agent present in the biological sample based on a difference between the baseline glucose level and the amount of glucose sensed.

12. The medication monitor of claim 1, wherein

the communication port is configured to output a recommendation to a health care provider to enable the health care provider to determine target drug levels or benchmark drug levels.

13. The medication monitor according to claim 1, wherein the solid support comprises a bead or a membrane.

14. The medication monitor according to claim 1, wherein

the communication port is configured to output a recommendation to a health care provider to enable the health care provider to determine target drug levels.

15. The medication monitor according to claim 1, wherein the enzyme is

an invertase, sucrase or sucrase-isomaltase that can convert sucrose to glucose,

a maltase that can convert maltose into glucose,

a trehalase that can convert trehalose into glucose,

an amylase that can convert starch into glucose, or

a cellulase that can convert cellulose into glucose.

16. The medication monitor according to claim 1, wherein

the detection device is hard wired to the medication monitor.

17. The medication monitor according to claim 1, wherein

the communications port is configured to wirelessly communicate the medication data to a data network.

18. A self-contained medication monitor comprising:

a housing body configured to contain medication;

a first detection device for detecting removal of medication from the self-contained medication monitor, the first detection device being integrally formed into the housing;

a second detection device having a target agent sensor for detecting a target agent in a biological sample from a user, the second detection device being integrally formed into the housing, wherein

the target agent sensor includes a plurality of sensors, where each sensor of the plurality of sensors comprises;

a solid support to which is attached a recognition molecule that specifically binds to the target agent in the presence of the target agent but not significantly to other agents;

a substance that can be enzymatically converted to glucose; and

an enzyme that can catalyze the conversion of the substance to glucose in the presence of the target agent;

a processor that produces medication usage data and medication data based on detected removal of the medication and an amount of glucose sensed and that outputs recommendations to the patient based on the medication usage data and medication data; and

a display device configured to display the recommendations to the patient;

wherein

each sensor of the plurality of sensors being configured to detect a different target agent, and

at least one sensor of the plurality of sensors is configured to detect Tacrolimus or a metabolite thereof.

19. A method of optimizing treatment of a medication recipient patient, comprising:

generating usage data regarding a patient'"'"'s compliance with a medication treatment regimen with the self-contained medication monitor of claim 18;

providing the usage data to a central server over a predetermined period of time;

determining the patient'"'"'s pattern of compliance with the medication treatment regimen;

collecting a biological sample with a detection device that is operatively connected to the medication monitor;

sensing a target agent with a target agent sensor integrated onto the detection device, the target agent sensor including a plurality of sensors, where each sensor of the plurality of sensors comprises;

a solid support to which is attached a recognition molecule that permits detection of the target agent, wherein the recognition molecule specifically binds to the target agent in the presence of the target agent but not significantly to other agents;

a substance that can be enzymatically converted to glucose;

an enzyme that can catalyze the conversion of the substance to glucose in the presence of the target agent; and

detecting the glucose produced from the substance with a glucose meter to generate medication data, wherein

the detection of glucose indicates a presence of the target agent in the biological sample, and an absence of detected glucose indicates an absence of the target agent in the biological sample;

correlating the patient'"'"'s pattern of compliance with the medication data and identifying, based on the detection of glucose, a pattern of misses in an initial treatment regimen; and

outputting at least one recommendation selected from the group consisting of;

changing at least one dosage of at least one medication used in the treatment regimen, and changing the timing of recommended usage of at least one medication in the treatment regimen;

wherein

the target agent comprises Tacrolimus or a metabolite thereof.

20. The self-contained medication monitor according to claim 18, wherein

the processor is configured to compare the amount of glucose sensed with a baseline glucose level and quantitatively determine an amount of each target agent present in the biological sample based on a difference between the baseline glucose level and the amount of glucose sensed.