Medical device and method with improved biometric verification

• US 9,943,252 B1
• Filed: 02/06/2014
• Issued: 04/17/2018
• Est. Priority Date: 08/13/2008
• Status: Active Grant

• Current Assignee: Cleveland Medical Devices Inc.
• Original Assignee: Cleveland Medical Devices Inc.
• Inventors: Kayyali, Hani
• Primary Examiner(s): Downey, John R
• Assistant Examiner(s): JIAN, SHIRLEY XUEYING
• Application Number:
  US14/173,897
• Time in Patent Office: 1,531 Days
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• 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 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/1172 using fingerprinting
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/398 Electrooculography [EOG], e.g. detecting nystagmus; Electroretinography [ERG]
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: G06V 40/10 Human or animal bodies, e.g. vehicle occupants or pedestrians; Body parts, e.g. hands
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

The present invention is both a device and a method for verifying a subject'"'"'s identity while using a medical device or undergoing a medical diagnostic or therapeutic procedure, particularly at home or at a remote location. The method and device can be used for inpatient and remote sleep and signal analysis with biometric identification. The present invention is further related to the devices and sensors used in executing the method, and includes various embodiments of a method of inpatient and remote sleep analysis.

Claims

1. A sleep diagnostic device adapted for providing sleep test data for analysis and diagnosis of sleep apnea by a clinician comprising:

an interface box with an air port connection adapted to connect with a nasal cannula or a mask, at least three sensors for measuring physiological parameters of a subject related to the subject'"'"'s quality of sleep, the at least three sensors being an air flow sensor internal to the interface box, a finger tip pulse oximeter and a respiratory effort belt, a processor and at least one biometric sensor for identifying the subject;

wherein the interface box houses the processor and having circuitry adapted to connect the at least three sensors and the biometric sensor to the processor, the processor is adapted to authenticate the identity of the subject being tested using data acquired by the biometric sensor and is adapted to output sleep test data from each of the at least three sensors for analysis and diagnosis by a clinician, and wherein the authentication is performed at random times during a sleep test.

2. The device of claim 1, wherein the device is adapted to use previously collected biometric data of the subject to verify the subject'"'"'s identity with the processor during the course of the sleep test.

3. The device of claim 1 wherein the device is used to collect biometric data, compare biometric data with previously collected biometric data, and adapted to securely exchange information to comply with HIPAA requirements with an external device through a transceiver on the device.

4. The device of claim 1, wherein the at least one biometric sensor is adapted to collect biometric data from a subject, the processor is adapted to compares the collected biometric data with biometric data previously collected from the subject, and the processor is adapted to outputs verification of the identity of the subject whose quality of sleep is being measured without outputting the subject'"'"'s biometric data.

5. The device of claim 1, wherein the at least one biometric sensor is a fingerprint sensor and the fingerprint sensor and the fingertip pulse oximeter being in a common housing adapted in such a manner as to require that fingerprint verification and pulse oximetry be performed on adjacent fingers of the subject'"'"'s hand.

6. A sleep diagnostic device adapted for providing sleep test data for analysis and diagnosis of sleep apnea by a clinician comprising:

an interface box with an air port connection adapted for connecting with a nasal cannula or mask, at least three sensors for measuring physiological parameters of a subject related to the subject'"'"'s quality of sleep the at least three sensors being an air flow sensor internal to the interface box, a finger tip pulse oximeter and a respiratory effort belt, a processor and at least one biometric sensor;

wherein the interface box houses the processor and having circuitry adapted to connect the at least three sensors and the biometric sensor to the processor, the processor is adapted for authentication of the identity of the subject being tested, and the at least one biometric sensor is further adapted for collection of biometric data from the subject, by having the processor compare the collected biometric data with biometric data previously collected from the subject, and the processor being adapted to output verification of the identity of the subject whose quality of sleep is being measured during a sleep test to a database or a display without outputting the subject'"'"'s biometric data and is adapted to output sleep test data from each of the at least three sensors for analysis and diagnosis by a clinician.

7. The device of claim 6, wherein authentication of subject identity by the processor using said biometric sensor is performed at random times.

8. The device of claim 6, wherein the device is adapted to use previously collected biometric data of the subject to verify the subject identity with the processor during the course of the sleep test.

9. The device of claim 6, wherein the device is used to collect biometric data, compare biometric data with previously collected biometric data, and is adapted to securely exchange information to comply with HIPAA requirements with an external device through a transceiver on the device.

10. The device of claim 6, wherein the biometric sensor is adapted to detect a biometric electrophysiological characteristic of the subject.

11. The device of claim 6, the device further comprising a memory for storing biometric data of the subject for comparison.

12. The device of claim 6, wherein the output verification to the database or display of the identity of the subject whose quality of sleep is being measured is a pass/fail.

13. A sleep diagnostic device adapted for providing sleep test data for analysis and diagnosis of sleep apnea by a clinician comprising:

an interface box with an air port connection adapted for connecting to a nasal cannula or mask, at least three sensors for measuring physiological parameters of a subject related to the subject'"'"'s quality of sleep, the at least three sensors being an air flow sensor internal to the interface box, a finger tip pulse oximeter and a respiratory effort belt, a processor, and at least one biometric sensor;

wherein the interface box houses the processor and having circuitry adapted to the at least three sensors and the biometric sensor to the processor, and the processor is adapted to authenticate the identity of the subject being tested by using a electrophysiological characteristic of the subject whose identity is being authenticated during a sleep test and to output sleep test data from each of the at least three sensors for analysis and diagnosis by a clinician.

14. The device of claim 13, wherein authentication of subject identity by the processor using said biometric sensor is performed at random times.

15. The device of claim 13, wherein the device is adapted to use previously collected biometric data of the subject to verify the subject identity with the processor during the course of the sleep test.

16. The device of claim 13, wherein output verification to a display of the sleep diagnostic device of the identity of the subject whose quality of sleep is being measured is a pass/fail.