Simultaneous multi-parameter physiological monitoring device with local and remote analytical capability

• US 10,022,053 B2
• Filed: 02/21/2014
• Issued: 07/17/2018
• Est. Priority Date: 02/22/2013
• Status: Active Grant

• Current Assignee: Cloud Dx, Inc.
• Original Assignee: Cloud Dx, Inc.
• Inventors: Li, Xinde, Sleight, Christian D. J., Valsan, Gopal, Kaul, Robert
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): PAHAKIS, MANOLIS Y
• Application Number:
  US14/186,151
• Publication Number:
  US 20140243612A1
• Time in Patent Office: 1,607 Days
• Field of Search: None
• 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 method of simultaneously monitoring pulse waveforms indicative of blood pressure, blood oxygen levels, and electrocardiogram signals, said method comprising:

providing a system, said system comprising;

a display;

a portable handheld base unit comprising a base unit processor, software, memory, an external chassis, and user control inputs;

a blood pressure monitoring cuff comprising tubing;

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

an external chassis mounted first ECG electrode, configured to touch a patient'"'"'s hand while said patient is holding said handheld base unit;

an ECG amplifier;

an external combination finger pulse oximeter-ECG electrode device that is separate from and external to said external chassis said external combination finger pulse oximeter-ECG electrode device comprising an interior;

a second ECG electrode arranged in said interior of said finger pulse oximeter-ECG electrode device;

a pulse oximeter arranged in said interior of said finger pulse oximeter-ECG electrode device, said pulse oximeter comprising a plurality of light sources and a photodetector;

an external chassis mounted electrical ECG-oximeter port for receiving input from said second ECG electrode and said pulse oximeter;

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

said blood pressure monitoring cuff connected to said external chassis mounted cuff port;

said external combination finger pulse oximeter-ECG electrode device connected to said external chassis mounted electrical ECG-oximeter port;

placing said blood pressure monitoring cuff around the arm of the other hand of the patient;

obtaining two lead electrocardiogram pulse wave information from only said first and second ECG electrodes by;

placing said external combination finger pulse oximeter-ECG electrode device around a digit of said other hand of said patient;

instructing said patient to hold said base unit so that said first ECG electrode makes electrical contact with said hand of said patient holding said base unit, while said second ECG electrode makes electrical contact with said digit of said patient;

producing synchronized pulse wave, hemoglobin absorbance, and two lead ECG waveforms of the same patient heart beats by, simultaneously in real time;

applying varying amounts of air pressure to said cuff, with said base unit processor, and obtaining pulse wave information data from said cuff as a function of air pressure;

driving said external combination finger pulse oximeter-ECG electrode device at a plurality of wavelengths, and obtaining with said base unit processor and said photodetector blood hemoglobin absorbance information data as a function of wavelength and as a function of said pulse wave;

monitoring said two-lead electrocardiogram pulse wave information from said first ECG electrode and second ECG electrode;

storing with said base unit processor

said pulse wave information data from said cuff, said, external combination finger pulse oximeter-ECG electrode device blood hemoglobin absorbance information, and said two lead electrocardiogram pulse wave information in either local memory or remote memory;

determining a diastolic and a systolic blood pressure from the pulse wave information from said cuff;

analyzing said diastolic and said systolic blood pressure based on the hemoglobin absorbance information; and

displaying the diastolic blood pressure, the systolic blood pressure, and the synchronized waveforms on said display.

2. The method of claim 1, further using said base unit processor to automatically transmit any or all of blood pressure monitoring pulse wave information data, 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, located external to said external chassis, via a wired, wireless, or optical communications port.

3. The method of claim 2, wherein said external computerized device or remote server comprises at least one server processor, and said data comprises pulse waveforms indicative of blood pressure, blood oxygen levels, and electrocardiogram signals;

further using said external computerized device or remote server'"'"'s at least one server processor to mathematically analyze said data producing server processor mathematically computed blood pressure, blood oxygen level, and ECG results, generate graphs of said data, and report on said server processor mathematically computed blood pressure, blood oxygen level, and ECG results.

4. The method of claim 2, wherein said external computerized device is a remote server comprising at least one server processor;

said data comprises pulse waveforms indicative of blood pressure, blood oxygen levels, and electrocardiogram signals;

using said at least one server processor on said remote server to analyze said data according to patient specific algorithms customized for a 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 medical alerts or drug dosage advisory messages according to patient specific algorithms customized for said health status of said individual patient.

5. The method of claim 4, further using said at least one server processor and pulse oximeter algorithms to indirectly determine a breathing rate of said patient from said finger pulse oximeter data, or to improve accuracy of blood pressure monitoring information obtained from said blood pressure monitoring cuff.

6. The method of claim 4, further using said at least one server processor, Chronic Obstructive Pulmonary Disease (COPD) drug dose algorithms, and said data to recommend or change dose levels of at least one drug used to treat COPD.

7. The method of claim 4, further using said at least one server processor, oscillometric analysis algorithms and said data to determine at least one of a systolic blood pressure, diastolic blood pressure, average pulse rate, variation in pulse rate, and pulse arrhythmia.

8. The method of claim 4, 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 medical 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.

9. The method of claim 4, 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 those medical analysis algorithms and/or patient specific drug dosage algorithms and parameters for said at least one server processor on said remote server to use to automatically analyze data from specific patients.

10. The method of claim 4, further transmitting duplicate copies of said automatically generated medical alerts or drug dosage advisory messages to both said patient and at least one physician.

11. The method of claim 1, wherein said two lead ECG device consists of said first ECG electrode and said second ECG electrode.