Apparatus and method for monitoring heart rate variability

• US 7,460,899 B2
• Filed: 02/25/2005
• Issued: 12/02/2008
• Est. Priority Date: 04/23/2003
• Status: Expired due to Fees

• Current Assignee: Respite LLC
• Original Assignee: Quiescent, Inc.
• Inventors: Almen, Adam J.
• Primary Examiner(s): Schaetzle; Kennedy J.
• Assistant Examiner(s): PATEL, NATASHA
• Application Number:
  US11/067,168
• Publication Number:
  US 20050177051A1
• Time in Patent Office: 1,376 Days
• Field of Search: 600/515, 600/519, 600/520, 600/481, 600/483, 128/897, 128/898, 340/575, 345/573.7
• US Class Current: 600/509
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/02455 provided with high/low alarm devices
• CPC Class Codes: A61B 5/398 Electrooculography [EOG], e.g. detecting nystagmus; Electroretinography [ERG]
• CPC Class Codes: A61B 5/4812 Detecting sleep stages or cycles
• CPC Class Codes: A61B 5/4815 Sleep quality
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/681 Wristwatch-type devices

Abstract

A wrist-worn or arm band worn heart rate variability monitor is provided. Heart rate variability (“HRV”) refers to the variability of the time interval between heartbeats and is a reflection of an individual'"'"'s current health status. Over time, an individual may use the results of HRV tests to monitor either improvement or deterioration of specific health issues. Thus, one use of the HRV test is as a medical motivator. When an individual has a poor HRV result, it is an indicator that they should consult their physician and make appropriate changes where applicable to improve their health. If an individual'"'"'s HRV results deviate significantly from their normal HRV, they may be motivated to consult their physician. In addition, the inventive monitor is capable of monitoring the stages of sleep by changes in the heart rate variability and can record the sleep (or rest) sessions with the resulting data accessible by the user or other interested parties. Alternate embodiments of the invention allow assistance in the diagnosis and monitoring of various cardiovascular and sleep breathing disorders and/or conditions. Other embodiments allow communication with internal devices such as defibrillators or drug delivery mechanisms. Still other embodiments analyze HRV data to assist the user in avoiding sleep.

Claims

1. A wrist or arm worn heart rate variability monitor, comprising:

at least one sensor embedded in a membrane for detecting heart rate signals generated within a body when placed in contact with the body'"'"'s wrist, wherein the sensor is capable of monitoring signals selected from the group consisting of optical, infra-red, pressure, ultrasonic and electrical signals;

a circuit that conditions the electrical signals and converts the analog signals to digital signal data;

a heart rate variability signal processor that monitors and analyzes the digital signal data, calculates parameters comprising the mean digital signal value and at least one standard deviation of the digital signal data monitored and establishes a threshold level based on the calculated parameters evaluated when the user is in an awake state and just prior to real-time heart rate variability data monitoring, wherein the calculated threshold level is neither predetermined nor preset and does reflect the user'"'"'s actual heart rate and heart rate variability over the defined time interval, and wherein the processor monitors the digital signal data and recognizes the crossing of the established threshold level by the digital signal data and may be programmed to establish a new threshold level into a subsequent sleep state that reflects the body'"'"'s actual heart rate and heart rate variability within the subsequent sleep state and then performs at least one HRV test using the new threshold level while the body is within the subsequent sleep state and then continues to monitor the body'"'"'s HRV for additional threshold crossings;

an alarm that may be activated to alert the user of abnormal conditions or events or the crossing of a specified threshold level by the heart rate variability; and

a memory capable of storing the established threshold levels and real time digital signal data.

2. The heart rate variability monitor of claim 1, wherein the at least one sensor comprises at least one piezoelectric sensor.

3. The heart rate variability monitor of claim 1, further wherein the at least one sensor comprises at least one micro electromechanical sensor.

4. The heart rate variability monitor of claim 1, further comprising the at least one sensor being selected from the group consisting of electrode sensors, optical sensors, cMUT sensors and piezoelectric sensors.

5. The heart rate variability monitor of claim 1, further comprising:

a transceiver for two-way communication with an internal device, wherein the alarm may be activated upon communication of a significant event to the transceiver by the internal device.

6. The heart rate variability monitor of claim 5, wherein the internal device communicates diagnostic data to the heart rate variability monitor.

7. The heart rate variability monitor of claim 5, further comprising communicating to the internal device that the significant event is permitted to occur, not permitted to occur, or permitted to occur but only after a period of time has passed.

8. The heart rate variability monitor of claim 5, wherein the internal device is a defibrillator and the significant event comprises defibrillation.

9. The heart rate variability monitor of claim 5, wherein the internal device is a drug delivery system and the significant event comprises delivery of the drug.

10. The heart rate variability monitor of claim 9, wherein the drug delivery system comprises an insulin pump and the significant event comprises delivery of insulin.

11. The heart rate variability monitor of claim 1, wherein the processor is capable of analyzing HRV data to determine when the user is entering the beginning stages of sleep and activating the alarm to ensure the user remains awake.

12. The heart rate variability monitor of claim 4, further comprising the monitor having a back surface;

and a conductive membrane comprising metal rubber disposed on the back surface of the monitor and contacting the at least one sensor and further having contact with the user'"'"'s skin.

13. The heart rate variability monitor of claim 4, further comprising an infra-red sensor, wherein the infra-red sensor monitors heart rate variability.

14. The heart rate variability monitor of claim 1, wherein the processor is capable of using the infra-red and/or optical signals to perform pulse oximetry analysis.

15. The heart rate variability monitor of claim 1, wherein the at least one sensor monitors blood oxygen levels to assist in diagnosing, monitoring or treating diseases, conditions or maladies.

16. The heart rate variability monitor of claim 1, further comprising a memory device.