Multi-stream data collection system for noninvasive measurement of blood constituents

• US 10,582,886 B2
• Filed: 10/07/2019
• Issued: 03/10/2020
• Est. Priority Date: 07/03/2008
• Status: Active Grant

• Current Assignee: Masimo Corporation
• Original Assignee: Masimo Corporation
• Inventors: Poeze, Jeroen, Lamego, Marcelo, Merritt, Sean, Dalvi, Cristiano, Vo, Hung, Bruinsma, Johannes, Lesmana, Ferdyan, Kiani, Massi Joe E., Olsen, Greg
• Primary Examiner(s): Winakur, Eric F
• Assistant Examiner(s): Liu, Chu Chuan
• Application Number:
  US16/594,980
• Publication Number:
  US 20200029867A1
• Time in Patent Office: 155 Days
• CPC Class Codes: A61B 2562/0233 Special features of optical sensors or probes classified in A61B5/00
• CPC Class Codes: A61B 2562/04 Arrangements of multiple sensors of the same type
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/146 for optical coupling
• 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 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/4875 Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/6816 Ear lobe
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/70 Means for positioning the patient in relation to the detecting, measuring or recording means
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor

Abstract

The present disclosure relates to noninvasive methods, devices, and systems for measuring various blood constituents or analytes, such as glucose. In an embodiment, a light source comprises LEDs and super-luminescent LEDs. The light source emits light at at least wavelengths of about 1610 nm, about 1640 nm, and about 1665 nm. In an embodiment, the detector comprises a plurality of photodetectors arranged in a special geometry comprising one of a substantially linear substantially equal spaced geometry, a substantially linear substantially non-equal spaced geometry, and a substantially grid geometry.

Claims

1. A user-worn physiological measurement device comprising:

a plurality of emitters configured to emit light into tissue of a user;

at least four detectors arranged on a substrate;

a cover comprising a single protruding convex surface, wherein the single protruding convex surface is configured to be located between tissue of the user and the at least four detectors when the physiological measurement device is worn by the user, wherein at least a portion of the single protruding convex surface is sufficiently rigid to cause tissue of the user to conform to at least a portion of a shape of the single protruding convex surface when the physiological measurement device is worn by the user;

one or more processors configured to;

receive one or more signals from at least one of the at least four detectors, the one or more signals responsive to at least a physiological parameter of the user; and

process the one or more signals to determine measurements of the physiological parameter;

a network interface configured to communicate with a mobile phone;

a touch-screen display configured to provide a user interface, wherein;

the user interface is configured to display indicia responsive to the measurements of the physiological parameter, and

an orientation of the user interface is configurable responsive to a user input;

a wall that surrounds at least the at least four detectors, wherein the wall operably connects to the substrate and the cover;

a storage device configured to at least temporarily store at least the measurements of the physiological parameter; and

a strap configured to position the physiological measurement device on the user.

2. The user-worn physiological measurement device of claim 1, wherein at least part of the single protruding convex surface is light permeable to allow light to reach at least one of the at least four detectors.

3. The user-worn physiological measurement device of claim 2, wherein the at least four detectors are arranged on a first surface of the substrate.

4. The user-worn physiological measurement device of claim 3, wherein:

the wall operably connects to the substrate on one side of the wall,

the wall operably connects to the cover on an opposing side of the wall, and

the wall surrounds at least the at least four detectors on the first surface.

5. The user-worn physiological measurement device of claim 4, further comprising a single unit wearable by the user, the single unit encompassing the plurality of emitters, the at least four detectors, the wall, the cover, the one or more processors, the network interface, and the storage device.

6. The user-worn physiological measurement device of claim 5, wherein a surface of the single unit positions the touch-screen display.

7. The user-worn physiological measurement device of claim 6, wherein the strap is attached to the single unit.

8. The user-worn physiological measurement device of claim 7, wherein the network interface is configured to communicate at least the measurements of the physiological parameter to the mobile phone.

9. The user-worn physiological measurement device of claim 7, wherein the network interface is further configured to wirelessly communicate with the mobile phone or with a computer network.

10. The user-worn physiological measurement device of claim 7, wherein the physiological parameter comprises at least one of:

pulse rate, glucose, oxygen, oxygen saturation, methemoglobin, total hemoglobin, carboxyhemoglobin, or carbon monoxide.

11. The user-worn physiological measurement device of claim 10 further comprising:

a magnet configured to be used as a connecting mechanism.

12. The user-worn physiological measurement device of claim 11, wherein the one or more processors are further configured to modulate a duty cycle of one or more of the plurality of emitters, and wherein the modulation includes pulse width time slots and off time slots.

13. The user-worn physiological measurement device of claim 12, wherein the displayed indicia are further responsive to temperature.

14. The user-worn physiological measurement device of claim 12, wherein the physiological parameter comprises a state or trend of wellness of the user.

15. The user-worn physiological measurement device of claim 12, wherein a portion of the physiological measurement device comprises one of at least two sizes, the two sizes intended to be appropriate for larger users and smaller users.

16. The user-worn physiological measurement device of claim 12, wherein the single protruding convex surface protrudes a height between 1 millimeter and 3 millimeters.

17. The user-worn physiological measurement device of claim 16, wherein the single protruding convex surface protrudes a height greater than 2 millimeters and less than 3 millimeters.

18. The user-worn physiological measurement device of claim 17, wherein each of the at least four detectors has a corresponding window that allows light to pass through to the detector.

19. The user-worn physiological measurement device of claim 18 further comprising:

an at least partially opaque layer blocking one or more optical paths to at least one of the at least four detectors, wherein the at least partially opaque layer comprises the windows that allow light to pass through to the corresponding detectors.

20. The user-worn physiological measurement device of claim 19, wherein the at least four detectors are arranged such that a first detector and a second detector of the at least four detectors are arranged across from each other on opposite sides of a central point along a first axis, and a third detector and a fourth detector of the at least four detectors are arranged across from each other on opposite sides of the central point along a second axis which is different from the first axis.

21. The user-worn physiological measurement device of claim 20, wherein the first axis is perpendicular to the second axis.

22. The user-worn physiological measurement device of claim 20, wherein the first, second, third and fourth detectors form a cross pattern about the central point.

23. The user-worn physiological measurement device of claim 19, wherein the wall creates one or more gaps between the first surface of the substrate and a surface of the cover that is interior to the physiological measurement device, and wherein the at least four detectors are positioned on the first surface of the substrate within the one or more gaps.

24. The user-worn physiological measurement device of claim 19, wherein the at least four detectors comprise at least eight detectors.

25. The user-worn physiological measurement device of claim 1, wherein at least one of the detectors is configured to detect light that has been attenuated by tissue of the user.

26. The user-worn physiological measurement device of claim 25, wherein the attenuated light is reflected by the tissue.

27. A physiological measurement system comprising:

the user-worn physiological measurement device according to claim 1; and

the mobile phone in communication with the physiological measurement device.

28. The physiological measurement system of claim 27, wherein the network interface of the physiological measurement device is configured to wirelessly communicate, and wherein the mobile phone wirelessly communicates with the network interface.

29. A physiological measurement system comprising:

the user-worn physiological measurement device according to claim 24; and

the mobile phone in communication with the physiological measurement device.

30. The physiological measurement system of claim 29, wherein the network interface of the physiological measurement device is configured to wirelessly communicate, and wherein the mobile phone wirelessly communicates with the network interface.