WIRELESS, DISPOSABLE, EXTENDED USE PULSE OXIMETER APPARATUS AND METHODS

• US 20180110450A1
• Filed: 12/07/2016
• Published: 04/26/2018
• Est. Priority Date: 12/07/2015
• Status: Active Grant

• Current Assignee: True Wearables, Inc.
• Original Assignee: True Wearables, Inc.
• Inventors: Lamego, Marcelo Malini, Lamego, Tatiana Buticosky
• Granted Patent: US 10,646,144 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2560/0285 Apparatus for single use
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 2562/166 the sensor is mounted on a specially adapted printed circuit board
• CPC Class Codes: A61B 2562/185 Optical shielding, e.g. baffles
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/02427 Details of sensor
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 5/6822 Neck
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6832 using adhesives A61B5/259 takes precedence
• CPC Class Codes: A61B 5/68335 including release sheets or liners
• CPC Class Codes: A61B 5/7435 : Displaying user selection data, e.g. icons in a graphical user interface
• CPC Class Codes: A61B 5/746 : Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G01J 2003/104 : Monochromatic plural sources
• CPC Class Codes: G01J 3/027 : Control of working procedures of a spectrometer; Failure detection; Bandwidth calculation
• CPC Class Codes: G01J 3/10 : Arrangements of light sources specially adapted for spectrometry or colorimetry
• CPC Class Codes: G01J 3/42 : Absorption spectrometry; Double beam spectrometry; Flicker spectrometry; Reflection spectrometry beam switching arrangements G01J3/08
• CPC Class Codes: G16H 40/67 : for remote operation

Abstract

Apparatus and methods provide wireless, disposable, continuous pulse oximeter sensor technology, useful and beneficial for a number of applications including relatively extended periods of data collection, and/or packaged in compact and easy-to-use assemblies. Economic fabrication and use provides flexible methodologies that can reduce the overall costs of monitoring and collecting patient'"'"'s physiological data, and provide relatively greater ease and comfort to the patient. A disposable wireless continuous pulse oximeter sensor has a reduced emitter-detector separation, a low-power frontend, and a low-cost processor that sends waveforms to a host device so that the host can calculate and display the parameters of interest. Complications created by the reduced distance between emitter and detector are minimized by using an emitter-detector assembly with an optically dark background, and a bandage for improved optical compliance.

Claims

1. Apparatus for gathering continuous medical data from a patient, including:

a wireless disposable assembly mountable on a patient;

said disposable assembly including a continuous pulse oximeter sensor, said sensor having at least one optically dark background cavity in the wavelength range of interest with at least one multi-wavelength light emitter and at least one light detector mounted to said cavity to detect the light from said light emitter reflected from the patient with negligible light-piping effects so as to acquire high signal-to-noise ratio data relating to at least one of the oxygen saturation level of blood, pulse rate, and blood perfusion index of the patient;

said disposable assembly including an electronic circuit assembly including (a) a processor, (b) a radio with antenna to transmit information collected by the assembly, (c) a frontend circuitry, (d) a power management circuitry, (e) a control circuitry, and (f) a battery to power the operation of said assembly, said circuit assembly configured to calculate from the information collected by the assembly at least one of the oxygen saturation level of blood, pulse rate, and blood perfusion index of the patient, and to transmit same wirelessly;

said disposable assembly including a single-use turn-ON switch to enable said sensor to start operation.

2. The apparatus of claim 1, wherein said battery includes a chemistry that provides a very flat voltage profile with discharge and has a short-contact gap to facilitate easy alignment of said battery after attachment to the assembly.

3. The apparatus of claim 1, in which said assembly has sufficient storage and power to continuously monitor the relevant data for the duration of a patient'"'"'s sleep cycle.

4. The apparatus of claim 1, further including a small-loop SMD antenna.

5. A method of gathering continuous medical data from a patient, including:

providing apparatus of claim 1;

affixing the apparatus to a patient; and

gathering the medical data.

6. The apparatus of claim 1, in which said single-use turn-ON switch is fabricated from at least one part each of conductive tape, conductive adhesive, and liner material

7. The apparatus of claim 1, in which said attachment mechanism is a biocompatible adhesive tape.

8. The apparatus of claim 1, in which the emitter-detector separation is in the range of 2.5 to 7 mm.

9. The apparatus of claim 1, in which the electronic circuit assembly executes time critical, high frequency, low latency and low complexity tasks related to the biosensing functions as well as all required wireless communication tasks in order to generate and transmit waveform data and parameters.

10. The apparatus of claim 1, in which said wirelessly transmitted item includes at least one of a waveform, control signal, and/or measurement.

11. The apparatus of claim 1, said disposable assembly including a biocompatible tape positioned to provide protection to said electronic circuit.

12. The apparatus of claim 1, said disposable assembly including an attachment mechanism to attach said assembly to the patient'"'"'s skin.

13. The apparatus of claim 1, further including a bandage further attaching said disposable assembly to the patient to increase optical compliance of said continuous pulse oximeter sensor and the patient'"'"'s skin, in order to increase optical penetration depth and minimize light piping and optical interference effects and increase amplitude of the photoplethysmograph, so as to improve signal-to-noise ratio of said information collected by the assembly.

14. The apparatus of claim 1, in which at least one component of said disposable assembly is separately connectable the rest of said disposable assembly and is modular and can be replaced by a similar component separately from disposing of the entire disposable assembly.

15. The apparatus of claim 14, in which at least one separately connectable component includes a battery.

16. The apparatus of claim 14, in which at least one separately connectable component includes a memory.

17. The apparatus of claim 14, in which at least one separately connectable component includes a both a memory and a battery.

18. The apparatus of claim 1, in which said electronic circuit assembly includes firmware that causes said electronic circuit assembly to automatically update wirelessly upon actuating said single-use turn-ON switch.

19. A continuous pulse oximeter distributed architecture system, including:

a wireless disposable single-patient use oximeter mountable on a patient'"'"'s skin, said oximeter including (a) at least one optical detector (b) at least one emitter, (c) a low-cost low-power processor, (d) a wireless radio, (e) integrated frontend circuitry, (f) a disposable battery, (g) a one-time ON switch, said processor executing time critical, high frequency, low latency and low complexity tasks related to said oximeter'"'"'s biosensing functions and wireless communication tasks to generate and transmit biosensed information, and

at least one host device that receives said wireless communication and said biosensed information from said oximeter and executes complex high-latency tasks with floating-point operations in order to estimate at least one of the oxygen saturation level of blood, pulse rate, and blood perfusion index of the patient.

20. The system of claim 19, in which said mountable oximeter includes biocompatible encapsulation of at least one of its components.

21. The system of claim 19, in which said biosensed information includes at least one of waveform data and parameters.

22. The system of claim 19, in which said at least one host device includes a mobile device.

23. The system of claim 19, in which said at least one host device includes an Internet-based service and said service communicates output to at least one monitor.

24. The system of claim 23, in which said at least one monitor is within the same room as the patient.

25. The system of claim 23, in which said at least one monitor is not within the same room as the patient.