SYSTEM AND APPARATUS FOR PROVIDING DIAGNOSIS AND PERSONALIZED ABNORMALITIES ALERTS AND FOR PROVIDING ADAPTIVE RESPONSES IN CLINICAL TRIALS

• US 20110112416A1
• Filed: 11/10/2009
• Published: 05/12/2011
• Est. Priority Date: 11/10/2009
• Status: Active Grant

• Current Assignee: Makor Issues & Rights Ltd.
• Original Assignee: Makor Issues & Rights Ltd.
• Inventors: MYR, David
• Granted Patent: US 8,838,217 B2
• Time in Patent Office: Days
• US Class Current: 600/509
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• 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 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: A61N 2005/0626 Monitoring, verifying, controlling systems and methods

Abstract

A personalized real-time automated cardiovascular monitoring system monitors abnormalities in a patient'"'"'s cardiovascular activity data through the use of individually adjusted electrocardiogram Holter apparatus (Holter/ECG device) that provides an automatic medical diagnosis of cardiac abnormalities and generates abnormality alert signals representative of certain abnormalities in patient'"'"'s cardiac activities. The signals are transmitted using a wireless network through a bi-directional wireless protocol to a medical dispatcher center. A response is generated according to the abnormality detected. Individual parameters indicative of patient'"'"'s cardio activities are personalized to allow for adjustments of chronic patients. A base Holter/ECG unit, includes the wireless/electric electrodes and their respective wireless/electric connections, and a Holter/ECG recording unit affixed to the base unit. The Holter/ECG apparatus can be integrated as a chip into a wireless device, such device being in a wireless phone network. Automatic real-time medical response may be provided to detection of risks of adverse effects resulting from use of at least one medication, based on automatic cardiac abnormality alert detection from the Holter/ECG data.

Claims

1. A method for providing cardiovascular personalized patient alerts for a patient, comprising:

a) enrolling the patient in a centralized medical database by inserting previously collected medical data and cardiological parameters of the patient;

b) creating “

resting”

personalized abnormality alert thresholds for the patient based on the inserted medical data and cardiological parameters;

c) providing the patient with a permanent Holter/ECG-type device, said Holter/ECG-type device being integrated as a chip into a wireless device that is part of a wireless phone network, said Holter/ECG-type device comprising a plurality of input buttons, the input buttons including a Medicine button for pressing when the patient has taken any particular medicine, a Sports button for pressing when the patient will be engaged in a sporting activity;

a Meal button for pressing when the patient will have a meal;

a Sleep button for pressing when the patient will start/finish his sleep; and

an Emergency button for pressing to contact the emergency center;

d) updating the “

resting”

personalized abnormality alert thresholds based on data inputted to the plurality of input buttons;

e) creating new personalized abnormality alert thresholds in real-time by analyzing new cardiological data of the patient obtained using the Holter/ECG-type device;

f) providing automatically and in real-time cardiological medical diagnosis by comparing data record by the Holter/ECG-type device with the new personalized abnormality alert thresholds;

g) generating automatically a medical abnormality alert based on said cardiological medical diagnosis;

h) transmitting said abnormality alert using the wireless phone network to a medical emergency center; and

i) providing an emergency response to the abnormality alert.

2. The method of claim 1, further comprising the steps of:

j) obtaining as an input from the centralized database initial patient personalized emergency alerts thresholds;

k) obtaining as an input real-time cardiological data of the patient from the Holter/ECG-type device, including the patient personalized emergency alerts thresholds;

l) updating said patient personalized emergency alerts thresholds with the real-time cardiological data.

3. The method of claim 1, further comprising the step of:

j) storing medical information obtained from the patient at the centralized database.

4. The method of claim 1, wherein said wireless device is a selected one of a cellular mobile telephone, a multimedia phone or a personal digital assistant (PDA).

5. The method of claim 1, further comprising the step of:

j) providing a wireless network architecture and infrastructure for facilitating a bi-directional exchange of information between the patient'"'"'s wireless device and the centralized database.

6. The method of claim 1, wherein step (h) comprises:

h) transmitting with said wireless device said abnormality alert via a cellular network to the said centralized database at the medical emergency center.

7. The method of claim 1, further comprising the step of:

j) determining an exact location of said wireless device by obtaining a wireless phone location of the wireless device or a GPS equipment-based location of the wireless device.

8. The method of claim 1, wherein step (i) comprises sending an ambulance in response to the abnormality alert.

9. The method of claim 8, wherein an exact location of said wireless device by obtaining a wireless phone location of the wireless device or a GPS equipment-based location of the wireless device, and the ambulance is sent to the patient'"'"'s exact location.

10. The method of claim 1, further comprising the step of:

j) providing an input capability for enabling the patient to input personal data including the time of meal intake.

11. The method of claim 1, wherein the wireless device includes a means for analyzing statistical data received from the centralized database.

12. The method of claim 11, wherein the wireless device includes a means for sending the analyzed statistical data to clinical trial providers in a format acceptable to the clinical trial providers.

19. The method of claim 1, wherein the wireless device further includes a blood pressure apparatus, and further comprising the step of:

j) transferring a blood pressure measurement taken with the blood pressure apparatus wirelessly to the medical emergency center after the generation of the medical abnormality alert.

20. The method of claim 1, wherein the blood pressure apparatus comprises:

an inflatable cuff chamber operable to be inflated during an inflation interval and deflated during a deflation interval;

a sensor coupled to said inflatable cuff chamber and configured to measure a blood pressure; and

a control electronic module configured for controlling the operation of said inflatable cuff chamber and said sensor.

21. The method of claim 20, further comprising the step of:

k) taking a permanent continuous blood pressure measurement in predetermined time-intervals.

22. The method of claim 21, further comprising the step of:

l) transmitting wirelessly a personalized abnormality blood pressure alert to the medical emergency center based on personalized blood pressure measurements thresholds.

23. The method of claim 22, further comprising the steps of:

m) obtaining as an input from the centralized database initial patient personalized blood pressure emergency alerts thresholds;

n) obtaining as an input real-time cardiological data of the patient from the continuous blood pressure measurement, including the initial patient personalized blood pressure emergency alerts thresholds;

o) updating said initial patient personalized blood pressure emergency alerts thresholds with the real-time cardiological data.

13. A method for providing automatic real-time medical response in clinical trials for detection of adverse effects and risks of adverse effects resulting from use of at least one medication or other medical treatment, based on automatic cardiac abnormality alert detection from Holter/ECG data, comprising the steps of:

a) identifying at least one medication or medical treatment for each clinical trial;

b) identifying a safe use profile for the at least one medication or medical treatment;

c) identifying a group of clinical trial participants that use the at least one medication or medical treatment and creating a database of the clinical trial participants;

d) identifying parameters of the safe use profile for the at least one medication or medical treatment used by the group of clinical trial participants;

e) supplying each clinical trial participant with a permanent Holter/ECG-type device, said Holter/ECG-type device being integrated as a chip into a wireless device that is part of a wireless phone network;

f) automatically and in real-time obtaining abnormality alerts data from the permanent Holter/ECG-type devices;

g) determining whether the abnormality alerts data is within the parameters of the safe use profile for the particular participant;

h) for abnormality alerts data that is outside of the parameters of the safe use profile for the particular participant, assessing the abnormality alerts data in combination with at least one of drugs data, foods data, beverages data, vitamins data, and other parameters data to determine whether the abnormality alerts data constitutes an adverse effect risk requiring emergency medical response;

i) providing an emergency medical alert if the abnormality alerts data constitutes an adverse effect risk.

14. The method of claim 13, further comprising the step of:

j) transmitting wirelessly to the participant a clinical trial medical order to change a dosage of said medication or medical treatment.

15. The method of claim 13, further comprising the step of:

j) transmitting wirelessly to the participant a clinical trial medical order to stop taking said medication or medical treatment.

16. The method of claim 13, further comprising the step of:

j) transmitting wirelessly to the participant a clinical trial medical order to start taking another medication or medical treatment.

17. The method of claim 13, further comprising the step of:

j) pulling the participant out of the clinical trial based at least in part on the abnormality alerts data.

18. The method of claim 13, further comprising the step of:

j) stopping the clinical trial based at least in part on the abnormality alerts data.

24. A system for monitoring cardiovascular activity of a patient comprising:

a plurality of sensors for generating data relating to the cardiovascular activity of the patient; and

a processor for generating personalized thresholds for said patient

a wireless device comprising;

a receiver configured to receive the data generated by the plurality of sensors;

a detector configured to detect abnormalities in the cardiovascular activity of the patient by comparing the received data with said personalized thresholds for the patient and generate alerts based on the detected abnormalities; and

a transmitter configured to transmit the generated alerts over a wireless network to a medical emergency center and receive a response over the wireless network from the medical emergency center,

said processor also for changing said personalized thresholds for said patient depending upon which of a plurality of activities said patient is engaging in and said processor is made aware of.

25. A method for monitoring cardiovascular activity of a patient, comprising the steps of:

obtaining data relating to the cardiovascular activity of the patient;

generating personalized thresholds for said patient and changing said personalized thresholds for said patient depending upon which of a plurality of activities said patient is engaging in and said processor is made aware of;

detecting abnormalities in the cardiovascular activity of the patient by comparing the obtained data with personalized cardiovascular activity thresholds for the patient;

generating alerts based on the detected abnormalities;

transmitting the alerts to a medical emergency center over a wireless network; and

receiving a response from the medical emergency center over the wireless network.

26. A method for providing real-time medical response to abnormal cardiovascular activity of a patient, comprising the steps of:

providing to the patient a recorder device for continuously monitoring the cardiovascular activity of the patient, said recorder device for generating personalized thresholds for said patient and changing said personalized thresholds for said patient depending upon which of a plurality of activities said patient is engaging in and said processor is made aware of;

receiving at a medical emergency center alerts indicating the abnormal cardiovascular activity of the patient from the recorder device via a wireless network; and

issuing the medical response to the patient in real-time based on the received alerts.

27. Apparatus for providing cardiovascular personalized patient alerts for a patient, comprising:

a plurality of sensors for generating data relating to the cardiovascular activity of the patient;

a plurality of input buttons, the input buttons including a medicine button for pressing when the patient has taken any particular medicine, a sports button for pressing when the patient will be engaged in a sporting activity;

a meal button for pressing when the patient will have a meal, a sleep button for pressing when the patient will start/finish his sleep; and

an emergency button for pressing to contact the emergency center;

a storage unit for storing thresholds based on the cardiovascular activity of the patient when the input buttons are pushed;

a transmitter for transmitting a medical abnormality alert based on a comparison of any of said thresholds with further data acquired from said patient by said sensors.