Medical device and method with improved biometric verification

• US 10,413,222 B1
• Filed: 03/02/2018
• Issued: 09/17/2019
• 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): Flory, Christopher A
• Assistant Examiner(s): Jian, Shirley X
• Application Number:
  US15/910,068
• Time in Patent Office: 564 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 system comprising a device for a sleep test, the system adapted for providing sleep test data for analysis and diagnosing sleep apnea, the device further comprising an interface box with at least one air port connection, 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 fingertip 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 having circuitry adapted to connect the at least three sensors and the biometric sensor to the processor to collect data for identification of the subject being tested using the data from the biometric sensor, the at least one biometric sensor is used to randomly collect data to authenticate the identity of the subject being tested during a sleep test, and the collected data is output for analysis and diagnosis by a clinician.

2. The system of claim 1, wherein the processor or another processor is adapted to use previously collected biometric data of the subject to verify the subject'"'"'s identity who took the sleep test.

3. The system of claim 1 wherein system compares the collected 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 system.

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

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

6. The system of claim 1 further including a transceiver adapted to transmit the data to a remote location.

7. The system of claim 1, wherein the biometric sensor is a fingerprint sensor.

8. A sleep diagnostic system comprising a device for a sleep test, the system adapted for providing sleep test data for analysis and diagnosing sleep apnea, the device further comprising an interface box with at least one air port connection, 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 fingertip 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 having circuitry adapted to connect the at least three sensors and the biometric sensor to the processor, to collect data for identification of the subject being tested using the data from the biometric sensor to compare with biometric data previously collected from the subject, and output of the collected data from the at least three sensors is further output for analysis and diagnosis by a clinician.

9. The system of claim 8, wherein authentication of subject identity by said biometric sensor is performed randomly.

10. The system of claim 8, wherein the system 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.

11. The system of claim 8, wherein the system compares the collected 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 system.

12. The system of claim 8, wherein the biometric sensor is adapted to detect a biometric electrophysiological characteristic of the subject.

13. The system of claim 8, the system further comprising a memory for storing biometric data of the subject for comparison.

14. The system of claim 8, wherein the processor or another processor in the system compares the biometric data with previously collected biometric data from the subject and outputs verification of the identity of the subject whose quality of sleep is being measured as a pass/fail.

15. A sleep diagnostic system comprising a device for a sleep test, the system adapted for providing sleep test data for analysis and diagnosing sleep apnea, the device further comprising an interface box with at least one air port connection, 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 fingertip pulse oximeter and a respiratory effort belt, a processor and at least one biometric sensor for identifying the subject wherein the biometric sensor is adapted to detect a biometric electrophysiological characteristic of the subject and the interface box houses the processor having circuitry adapted to connect the at least three sensors and the biometric sensor to the processor, to collect data for identification of the subject being tested using the data from the biometric sensor to compare with biometric data previously collected from the subject, and output of the collected data from the at least three sensors is further output for analysis and diagnosis by a clinician.

16. The system of claim 15, wherein authentication of subject identity by said biometric sensor is performed randomly.

17. The device of claim 15, wherein the processor or another processor in the system compares the biometric data with previously collected biometric data from the subject and outputs verification of the identity of the subject whose quality of sleep is being measured as a pass/fail.

18. The system of claim 15, wherein the processor or another processor compares the collected biometric data with the biometric data previously collected from the subject, and the processor outputs verification of the identity of the subject whose quality of sleep is being measured without outputting the subject'"'"'s biometric data.

19. The system of claim 18, wherein biometric data is loaded onto the sleep diagnostic device from an already existent source.

20. The system of claim 15, wherein the biometric sensor is an EKG sensor.