SIMULTANIOUS MULTI-PARAMETER PHYSIOLOGICAL MONITORING DEVICE WITH LOCAL AND REMOTE ANALYTICAL CAPABILITY

• US 20140243612A1
• Filed: 02/21/2014
• Published: 08/28/2014
• Est. Priority Date: 02/22/2013
• Status: Active Grant

• Current Assignee: Cloud Dx, Inc.
• Original Assignee: Biosign Technologies, Inc.
• Inventors: Li, Xinde, Sleight, Christian D. J., Valsan, Gopal, Kaul, Robert
• Granted Patent: US 10,022,053 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• 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 5/02233 Occluders specially adapted therefor tourniquets A61B17/132
• 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 5/6826 Finger
• CPC Class Codes: A61B 5/7435 Displaying user selection data, e.g. icons in a graphical user interface

Abstract

Handheld medical diagnostic instrument that provides high time-resolution pulse waveforms associated with multiple parameters including blood pressure measurements, blood oxygen saturation levels, electrocardiograph (ECG) measurements, and temperature measurements. The device stores and analyzes the pulse waveforms simultaneously obtained from all tests, and thereby allows an unusually detailed view into the functioning of the user'"'"'s cardiovascular heart-lung system. The device is designed for use by unskilled or semi-skilled users, thus enabling sophisticated cardiovascular measurements to be obtained in a home environment. Data from the device can be analyzed onboard, with local computerized devices, and with remote server based systems. The remote server may be configured to analyze this data according to various algorithms chosen by the physician to be most appropriate to that patient'"'"'s particular medical condition (e.g. COPD patient algorithms). The server may be further configured to automatically provide alerts and drug recommendations.

Claims

1. A portable handheld device for simultaneously monitoring pulse waveforms indicative of blood pressure, blood oxygen levels, and electrocardiogram signals, said device comprising:

a handheld base unit comprising a microprocessor or microcontroller, software, memory, display, and user control inputs;

said handheld base unit further comprising an air pump and valve for driving a blood pressure monitoring cuff, at least one detector to monitor pulse input from said blood pressure monitoring cuff, and an external cuff port to accommodate the tubing for said blood pressure monitoring cuff;

said handheld base unit further comprising an external first ECG electrode configured to touch the patient'"'"'s hand while the patient is holding said handheld base unit, ECG amplifier, and an electrical ECG/oximeter port to receive input from a second ECG electrode mounted on the interior of an external finger pulse oximeter/ECG electrode device, thereby also obtaining electrocardiogram pulse wave information;

said electrical ECG/oximeter port further configured to drive a plurality of finger pulse oximeter light sources at a plurality of wavelengths, and to receive photodetector signals from said finger pulse oximeter/ECG electrode device;

wherein when a blood pressure monitoring cuff is plugged into said external cuff port and placed around the limb of a patient, and said external finger pulse oximeter/ECG electrode device is further placed around a digit of said patient, said device is configured to apply varying amounts of air pressure to said cuff and obtain pulse wave information from said cuff, said device is also configured drive said external finger pulse oximeter/ECG electrode device at a plurality of wavelengths, and obtain blood hemoglobin absorbance information as a function of wavelength and as a function of pulse wave, and said device is configured to monitor electrical signals from said first ECG electrode and second ECG electrodes, thereby deriving electrocardiogram pulse wave information;

wherein said device software is configured to direct said microprocessor or microcontroller to store in either local or remote memory, either direct or mathematically processed versions of said blood pressure monitoring pulse wave information, said external finger pulse oximeter/ECG electrode device blood hemoglobin absorbance information as a function of wavelength pulse wave information, and said electrocardiogram pulse wave information.

2. The device of claim 1, wherein said device software and processor is further configured to use said blood hemoglobin absorbance information as a function of wavelength and as a function of pulse wave to improve the accuracy of blood pressure monitoring information obtained from said blood pressure monitoring cuff.

3. The device of claim 1, wherein said device is configured to transmit any or all of said blood pressure monitoring pulse wave information data, said external finger pulse oximeter/ECG electrode device blood hemoglobin absorbance information data, and said electrocardiogram pulse wave information, along with device air pressure information data and light source driving information data, to an external computerized device or remote server via a wired, wireless, or optical communications port.

4. The device of claim 3, wherein said external computerized device or remote server is configured to analyze said data, generate medically useful graphs of said data, and report on mathematically computed blood pressure, blood oxygen level, and ECG results.

5. The device of claim 3, wherein said external computerized device is a remote server, and wherein said remote server is further configured to analyze said data according to patient specific algorithms customized for the health status of an individual patient using said device;

and

wherein said remote server is further configured to automatically generate at least one of medical alerts or drug dosage advisory messages according to patient specific algorithms customized for the health status of said individual patient;

or

wherein said remote server is further configured to automatically generate quality assurance alerts.

6. The device of claim 1, wherein at least one of said plurality of light sources is set at a wavelength where the absorbance of blood hemoglobin changes substantially as a function of the degree of oxygenation of said blood hemoglobin, and at least one of said plurality of light sources is set at a wavelength where the absorbance of blood hemoglobin changes minimally as a function of the degree of oxygenation of said blood hemoglobin;

and where said air pump and valves are configured to deliver air pressure to said cuff at varying pressure levels set to allow said device to obtain medically useful blood pressure readings.

7. The device of claim 1, further comprising a blood pressure monitoring cuff configured to detachably plug into said external cuff port;

and

a combination external pulse oximeter/ECG electrode device configured to detachably plug into said electrical ECG/oximeter port.

8. The device of claim 1, further comprising a blood pressure monitoring cuff configured to permanently plug into said external cuff port;

and

a combination external pulse oximeter/ECG electrode device configured to permanently plug into said electrical ECG/oximeter port.

9. The device of claim 1, wherein said software is configured to compute at least blood pressure results, blood oxygen level results, and graphically display electrocardiogram signal results as a function of time, and display said results on said display without the need of interfacing with an external computerized device or remote server.

10. The device of claim 1, wherein either said external finger pulse oximeter/ECG electrode device or said handheld base unit further comprises a temperature sensor configured to monitor the body temperature of said patient.

11. A method of simultaneously monitoring pulse waveforms indicative of blood pressure, blood oxygen levels, and electrocardiogram signals, said method comprising:

providing a portable handheld base unit comprising a microprocessor or microcontroller, software, memory, display, and user control inputs;

said handheld base unit further comprising an air pump and valve for driving a blood pressure monitoring cuff, at least one detector to monitor pulse input from said blood pressure monitoring cuff, and an external cuff port to accommodate the tubing for said blood pressure monitoring cuff;

said handheld base unit further comprising an external first ECG electrode configured to touch the patient'"'"'s hand while the patient is holding said handheld base unit, ECG amplifier, and an electrical ECG/oximeter port to receive input from a second ECG electrode mounted on the interior of an external finger pulse oximeter/ECG electrode device, thereby also obtaining electrocardiogram pulse wave information;

said electrical ECG/oximeter port further configured to drive a plurality of finger pulse oximeter light sources at a plurality of wavelengths, and to receive photodetector signals from said finger pulse oximeter/ECG electrode device;

said blood pressure monitoring cuff being plugged into said external cuff port;

said external finger pulse oximeter/ECG electrode device being plugged into said electrical ECG/oximeter port;

placing said blood pressure monitoring cuff around the limb of a patient;

placing said external finger pulse oximeter/ECG electrode device around the digit of said patient;

instructing said patient to hold said base unit so that said first ECG electrode makes electrical contact with the hand of said patient holding said base unit, while said second ECG electrode makes electrical contact with a digit on either a different hand or a toe of said patient;

using said air pump and valve to apply varying amounts of air pressure to said cuff and obtaining pulse wave information data from said cuff as a function of air pressure;

driving said external finger pulse oximeter/ECG electrode device at a plurality of wavelengths, and using said photodetector to obtain blood hemoglobin absorbance information data as a function of wavelength and as a function of pulse wave;

monitoring electrical signals from said first ECG electrode and second ECG electrodes, thereby deriving electrocardiogram pulse wave information data;

using said microprocessor or microcontroller to store either direct or mathematically processed versions of said blood pressure monitoring pulse wave information, said external finger pulse oximeter/ECG electrode device blood hemoglobin absorbance information as a function of wavelength pulse wave information, and said electrocardiogram pulse wave information in either local memory or remote memory.

12. The method of claim 11, further using said microprocessor or microcontroller to transmit any or all of said blood pressure monitoring pulse wave information data, said external finger pulse oximeter/ECG electrode device blood hemoglobin absorbance information data, and said electrocardiogram pulse wave information, along with device air pressure information data and light source driving information data, to an external computerized device or remote server via a wired, wireless, or optical communications port.

13. The method of claim 12, wherein said external computerized device or remote server comprises at least one processor, further using said external computerized device or remote server'"'"'s at least one processor to analyze said data, generate medically useful graphs of said data, and report on mathematically computed blood pressure, blood oxygen level, and ECG results.

14. The method of claim 12, wherein said external computerized device is a remote server comprising at least one server processor;

using said at least one server processor on said remote server to analyze said data according to patient specific algorithms customized for the health status of an individual patient using said device; and

further using said at least one server processor on said remote server to automatically generate medial alerts or drug dosage advisory messages according to patient specific algorithms customized for the health status of said individual patient.

15. The method of claim 14, further using pulse oximeter algorithms to indirectly determine the breathing rate of said patient from said finger pulse oximeter data, or to improve the accuracy of blood pressure monitoring information obtained from said blood pressure monitoring cuff.

16. The method of claim 14, further using COPD drug dose algorithms and said data to recommend or change dose levels of at least one drug used to treat COPD.

17. The method of claim 14, further using oscillometric analysis algorithms and said data to determine at least one of the systolic blood pressure, diastolic blood pressure, average pulse rate, variation in pulse rate, and pulse arrhythmia.

18. The method of claim 14, further uploading patient specific medical analysis parameters and patient specific drug dosage algorithm parameters to said server, and using at least one server processor, said data, said patient specific medial analysis parameters, and said patient specific drug dosage algorithm parameters to recommend or change dose levels of at least one drug used to treat said patient.

19. The method of claim 14, further providing a plurality of medical analysis algorithms and parameters and patient specific drug dosage algorithms and parameters on said server, and providing a menu allowing an authorized physician to select which of said plurality of medical analysis algorithms and/or patient specific drug dosage algorithms and parameters are to be used to analyze data from specific patients.

20. The method of claim 14, further transmitting duplicate copies of said automatically generated medial alerts or drug dosage advisory messages to both said patient and said physician.