SYSTEMS AND METHODS FOR MONITORING PATIENT MEDICATION ADHERENCE

• US 20160188839A1
• Filed: 03/03/2016
• Published: 06/30/2016
• Est. Priority Date: 02/22/2013
• Status: Active Grant

• Current Assignee: Cloud Dx, Inc.
• Original Assignee: Cloud Dx, Inc.
• Inventors: Ross-Howe, Sara, Kaul, Robert, Pedro, Justin
• Granted Patent: US 9,946,844 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0468 Built-in electrodes
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02125 of pulse wave propagation time
• CPC Class Codes: A61B 5/0225 the pressure being controlled by electric signals, e.g. derived from Korotkoff sounds
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/6822 Neck
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Invention for determining a patient'"'"'s adherence to various prescribed medications. Here a variety of different types of patient pulse wave measurements (blood pressure, pulse oximeter, ECG) and other physiological measurements are obtained. This actual data is compared to calculated measurements that would be expected based on the various patient baseline measurements in the absence of medication, schedule of medications, and impact of medications the various patient baseline measurements. If the actual data meets expectations, then the patient is likely adhering to the regime. Depending on which types of data do not meet expectations, non-adherence to various previously described medications may be reported. Other types of patient physiological readings, such as temperature, motion, lung function, brain wave function (EEG) and the like may also be obtained, and these additional types of readings can be used to extend the range of different types of drugs/medications that the invention can successfully monitor.

Claims

1. A method for determining a patient'"'"'s adherence to a medication regime, said method comprising:

obtaining patient operable instrumentation comprising a plurality of physiological monitoring devices configured to obtain a plurality of different types of actual patient pulse wave measurements;

said patient operable instrumentation further comprising at least one processor and memory;

obtaining a plurality of medication impact parameters, each individual medication impact parameter providing information on how a specific medication alters a specific type of pulse wave measurements;

obtaining a plurality of patient reference information, each individual patient reference information providing information on a specific type of patient baseline pulse wave measurements in an absence of medication;

obtaining medication schedule information pertaining to at least one medication and medication dosing schedule for said patient;

wherein when said patient operable instrumentation is used on a patient with medication schedule information;

using said at least one processor to analyze said plurality of different types of actual patient pulse wave measurements at a known time, and determining which of said plurality of different types of actual patient pulse wave measurements are inconsistent with those expected patient pulse wave measurements calculated from said medication schedule information, said known time, said plurality of patient reference information, and said plurality of medication impact parameters;

and storing at least those medications where inconsistent findings were obtained in said memory.

2. The method of claim 1, wherein said patient operable instrumentation and said physiological monitoring devices are configured to provide a first plurality of types of actual patent pulse wave measurements, said first plurality of types comprising at least two types taken from time varying blood oxygen saturation levels, time varying electrocardiograph (ECG) readings, and time varying blood pressure measurements types;

and

wherein said plurality of medication impact parameters and plurality of patient reference information further provide information pertaining to at least said first plurality of types.

3. The method of claim 2, further obtaining patient alarm information, said patient alarm information reporting on when any of blood oxygen saturation, blood pressure measurements, or electrocardiograph readings fall outside of previously established boundaries;

and

using said patient alarm information and those medications where inconsistent findings were obtained to determine and report that said patient may be out of compliance with taking those medications.

4. The method of claim 2, further determining if inconsistent findings were obtained over more than one different type of actual patient pulse wave measurements;

and

when at least two different types of actual patient pulse wave measurements have inconsistent findings, then determining and reporting that said patient may be out of compliance with taking those medications.

5. The method of claim 2, wherein said patient operable instrumentation and said physiological monitoring devices are a unitized system, all managed by at least one common processor.

6. The method of claim 1, wherein said plurality of medication impact parameters is obtained by from at least one of either:

a) averages over a plurality of similar patients in a presence and absence of said medication, further computing difference parameters between said presence and absence of said medication;

b) data obtained from said patient in said presence and absence of said medication, further computing difference parameters between said presence and absence of said medication.

7. The method of claim 1, wherein said plurality of patient reference information is obtained from at least one of either:

a) averages over a plurality of similar patients in an absence of said medication;

b) data obtained from said patient in said absence of said medication.

8. The method of claim 1, wherein said expected patient pulse wave measurements are calculated from said medication schedule information, said known time, said plurality of patient reference information, and said plurality of medication impact parameters by using said processor to transform said plurality of patient reference information into said expected patient pulse wave measurements by the steps of:

for each individual medication in said medication schedule information;

a) selecting corresponding individual medication impact parameters from said plurality of medication impact parameters, thereby producing selected individual medication impact parameters;

b) applying, either analytically or empirically, said selected individual medication impact parameters to said plurality of patient reference information, thereby producing intermediate transformed patient reference information;

c) repeating steps a and b until all individual medication in said medication schedule information has been processed, thereby producing said expected patient pulse wave measurements.

9. The method of claim 1, wherein said patient operable instrumentation is further configured to receive compliance information from said patient reporting on periods of at least one of patient medication compliance or non-compliance, and to use said compliance information to select at least some actual patient pulse wave measurements for use in establishing or refining at least some of said medication impact parameters or said patient reference information.

10. The method of claim 1, further reporting at least some of those medications where inconsistent findings were obtained to a remote computerized device over a network;

and storing least some of those medication where inconsistent findings were obtained in at least one remote network computer memory.

11. The method of claim 1 wherein any of said plurality of medication impact parameters, plurality of patient reference information, and medication schedule information is either uploaded or downloaded over a network from a remote computerized device.

12. A device for determining a patient'"'"'s adherence to a medication regime, said device comprising:

patient operable instrumentation comprising physiological monitoring devices configured to obtain a plurality of different types of actual patient pulse wave measurements;

said patient operable instrumentation further comprising at least one processor and memory;

wherein said patient operable instrumentation and said physiological monitoring devices are configured to provide a first plurality of types of actual patent pulse wave measurements, said first plurality of types comprising at least two types taken from varying blood oxygen saturation levels, time varying electrocardiograph (ECG) readings, and time varying blood pressure measurements types;

wherein said patient operable instrumentation and said physiological monitoring devices are a unitized system, all managed by at least one common processor;

wherein said device is configured to store a plurality of medication impact parameters, each individual medication impact parameter providing information on how a specific medication alters a specific type of pulse wave measurements;

wherein said plurality of medication impact parameters and plurality of patient reference information further provide information pertaining to at least said first plurality of types;

wherein said device is further configured to store a plurality of patient reference information, each individual patient reference information providing information on a specific type of patient baseline pulse wave measurements in an absence of medication;

wherein said device is further configured to store medication schedule information pertaining to at least one medication and medication dosing schedule for said patient;

said at least one processor further configured so that when said patient operable instrumentation is used on a patient with medication schedule information, said at least one processor analyzes said plurality of different types of actual patient pulse wave measurements at a known time, and determines which of said plurality of different types of actual patient pulse wave measurements are inconsistent with those expected patient pulse wave measurements calculated from said medication schedule information, said known time, said plurality of patient reference information, and said plurality of medication impact parameters;

wherein said at least one processor is further configured to store at least those medications where inconsistent findings were obtained in said memory.

13. The device of claim 12, wherein said at least one processor is further configured to provide patient alarm information, said patient alarm information reporting on when any of blood oxygen saturation, blood pressure measurements, or electrocardiograph readings fall outside of previously established boundaries;

and

Wherein said device is configured to use said patient alarm information and those medications where inconsistent findings were obtained to determine and report that said patient may be out of compliance with taking those medications.

14. The device of claim 12, wherein said at least one processor is further configured to determine if inconsistent findings were obtained over more than one different type of actual patient pulse wave measurements;

and

Wherein said device is configured so that when at least two different types of actual patient pulse wave measurements have inconsistent findings, said device further determines and reports that said patient may be out of compliance with taking those medications.

15. The device of claim 12, wherein said at least one processor is further configured to calculate said expected patient pulse wave measurements from said medication schedule information, said known time, said plurality of patient reference information, and said plurality of medication impact parameters by using said processor to transform said plurality of patient reference information into said expected patient pulse wave measurements by the steps of:

for each individual medication in said medication schedule information;

a) selecting corresponding individual medication impact parameters from said plurality of medication impact parameters, thereby producing selected individual medication impact parameters;

b) applying, either analytically or empirically, said selected individual medication impact parameters to said plurality of patient reference information, thereby producing intermediate transformed patient reference information;

c) repeating steps a and b until all individual medication in said medication schedule information has been processed, thereby producing said expected patient pulse wave measurements.

16. The device of claim 12, wherein said patient operable instrumentation is further comprises means to receive compliance information from said patient reporting on periods of at least one of patient medication compliance or non-compliance;

and

wherein said at least one processor is further configured to use said compliance information to select at least some actual patient pulse wave measurements for use in establishing or refining at least some of said medication impact parameters or said patient reference information.

17. The device of claim 12, further configured with network interface means to allow said device to connect with at least one remote computerized device over a network;

wherein said at least one processor is further configured report at least some of those medications where inconsistent findings were obtained to said remote computerized device; and

/or

wherein said at least one processor is further configured to enable any of said plurality of medication impact parameters, plurality of patient reference information, and medication schedule information is either uploaded or downloaded over a network from a remote computerized device.

18. The device of claim 12, further configured with at least one of a body temperature sensor and an accelerometer sensor, at least one lung function sensor, and a time varying electroencephalographic (EEG) reading sensor;

wherein said plurality of patient reference information further comprises at least one of baseline body temperature information, baseline patient motion data, baseline patient lung status data, or baseline patient EEG data;

wherein at least some of said individual medication impact parameters further provide information on how a specific medication alters at least one of said baseline body temperature information, said baseline patient motion data, baseline patient lung function, and said patient baseline EEG data;

wherein said at least one processor is further configured to use said medication schedule information, said known time, said plurality of patient reference information and at least some of said individual medication impact parameters to further determine if at least some medications are producing inconsistent findings.