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

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.

What is claimed is: 
     
         1 . A medication monitor comprising:
 a housing configured to contain medication;   a detection device having a target agent sensor for detecting a target agent in a biological sample from a user, wherein   the target agent sensor 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 data based on an amount of glucose sensed; and   a communication port configured to communicate the medication data to a data network.   
     
     
         2 . The medication monitor according to  claim 1 , wherein
 the detection device includes a sample collection device.   
     
     
         3 . The medication monitor according to  claim 2 , wherein
 the sample collection device is a skin-prick device.   
     
     
         4 . The medication monitor according to  claim 1 , wherein
 the detection device is wirelessly connected to the medication monitor.   
     
     
         5 . The medication monitor according to  claim 1 , wherein
 the detection device is hard wired to the medication monitor.   
     
     
         6 . 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.   
     
     
         7 . The medication monitor according to  claim 6 , 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.   
     
     
         8 . The medication monitor according to  claim 1 , wherein the target agent is an immunosuppressant or a metabolite thereof. 
     
     
         9 . The medication monitor according to  claim 1 , wherein the target agent is Tacrolimus or a metabolite thereof. 
     
     
         10 . The medication monitor according to  claim 9 , 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. 
     
     
         11 . The medication monitor according to  claim 9 , wherein the enzyme is attached to a molecule that binds to Tacrolimus or a metabolite thereof that is bound to the recognition molecule. 
     
     
         12 . The medication monitor according to  claim 1 , wherein the solid support comprises a bead or a membrane. 
     
     
         13 . The medication monitor according to  claim 1 , wherein the recognition molecule includes a nucleic acid molecule, a protein, a polymer, or an antibody that specifically binds to the target agent. 
     
     
         14 . 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.   
     
     
         15 . The medication monitor according to  claim 1 , wherein the target agent sensor includes a plurality of sensors, each sensor of the plurality of sensors sensing a target agent specific to that sensor. 
     
     
         16 . The medication monitor according to  claim 15 , wherein each sensor of the plurality of sensors is configured to detect a different target agent. 
     
     
         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 . The medication monitor of  claim 7 , wherein the medication sensor is configured to sense an indicium of origin of manufacture of the medication to verify authenticity of the medication. 
     
     
         19 . The medication monitor of  claim 18 , wherein the indicium of origin is provided by an information source associated with a pre-filled medication cartridge that is insertable into said opening. 
     
     
         20 . The medication monitor of  claim 19 , 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. 
     
     
         21 . The medication monitor of  claim 18 , wherein the information source is at least one member selected from the group consisting of size, shape and color of the medication. 
     
     
         22 . The medication monitor of  claim 19 , wherein the housing includes a plurality of housings for containing a plurality of pre-filled medication cartridges. 
     
     
         23 . The medication monitor of  claim 22 , wherein a shape of each of the plurality of housings is configured to match a specific shape of each pre-filled medication cartridge. 
     
     
         24 . 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 drag levels or benchmark drag levels.   
     
     
         25 . The medication monitor of  claim 1 , wherein
 the processor is configured to compare the amount 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.   
     
     
         26 . 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 a medication monitor;   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 provided with the detection device, the sensor comprising:
 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 fee 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 fee 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   outputting at least one recommendation selected from the group consisting of:   replacing at least one medication used in the treatment regimen with at least one different medication, changing at least one dosage of at least one medication used in the treatment regimen, changing the tuning of recommended usage of at least one medication in the treatment regimen, and not changing the treatment regimen.   
     
     
         27 . The method of  claim 26 , wherein the medication data relates to a concentration of medication in the patient's bloodstream. 
     
     
         28 . The method of  claim 26 , wherein the medication data is provided to the central server. 
     
     
         29 . The method of  claim 28 , wherein the medication data is provided to the central server by the medication monitor. 
     
     
         30 . The method of  claim 26 , wherein
 the detection device includes a skin-prick device.   
     
     
         31 . The medication monitor according to  claim 26 , wherein
 the detection device is wirelessly connected to the medication monitor.   
     
     
         32 . The method of  claim 26 , wherein
 the detection device is hard wired to the medication monitor.   
     
     
         33 . The method of  claim 26 , wherein
 the biological sample includes at least one of blood, urine and saliva.   
     
     
         34 . The method of  claim 26 , wherein the patient is a transplant recipient, and the medication comprises an immunosuppressant. 
     
     
         35 . The method of  claim 34 , wherein the immunosuppressant is Tacrolimus. 
     
     
         36 . The method of  claim 35 , wherein the enzyme is attached to a Tacrolimus analogue molecule or a Tacrolimus metabolite analogue molecule that competes less strongly than Tacrolimus or a metabolite thereof for binding to the recognition molecule. 
     
     
         37 . The method of  claim 35 , wherein the enzyme is attached to a molecule that binds to Tacrolimus or a metabolite thereof that is bound to the recognition molecule. 
     
     
         38 . The method of  claim 26 , further comprising:
 correlating the patient's pattern of compliance and medication data with patterns of compliance and medication data from a population of patients; and   outputting the at least one recommendation based on both the patient's pattern of compliance and medication data and the patterns of compliance and medication data from the population of patients.   
     
     
         39 . The method of  claim 26 , wherein the treatment regimen is a standardized treatment regimen. 
     
     
         40 . The method of  claim 26 , wherein the treatment regimen is an individual patient treatment regimen. 
     
     
         41 . The method of  claim 26 , further comprising:
 outputting a recommendation to a health care provider to enable the health care provider to determine target drug levels or benchmark drug levels.   
     
     
         42 . The method of  claim 26 , further comprising:
 comparing the amount glucose produced with a baseline glucose level and quantitatively determining 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.   
     
     
         43 . 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;   a second detection device having a target agent sensor for detecting a target agent in a biological sample from a user, wherein   the target agent sensor 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.   
     
     
         44 . The self-contained medication monitor according to  claim 39 , wherein
 the processor 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.   
     
     
         45 . The self-contained medication monitor according to  claim 39 , wherein
 the processor is configured to compare the amount 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.