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

• US 10,610,138 B2
• Filed: 08/19/2019
• Issued: 04/07/2020
• 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:
  US16/544,755
• Publication Number:
  US 20190374135A1
• Time in Patent Office: 232 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 that defines a plurality of optical paths, the physiological measurement device comprising:

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

at least four detectors positioned on a first surface and surrounded by a wall that is operably connected to the first surface; and

a cover operably connected to the wall and comprising a single protruding convex surface 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 the physiological measurement device provides a plurality of optical paths, wherein each of the optical paths;

exits an emitter of the plurality of emitters,

passes through tissue of the user,

passes through the single protruding convex surface, and

arrives at a corresponding detector of the at least four detectors, the corresponding detector configured to detect light emitted by the emitter after traversal by the light of a corresponding optical path of the plurality of optical paths and after attenuation of the light by tissue of the user.

2. The user-worn physiological measurement device of claim 1, wherein each of the optical paths further:

passes through a corresponding space formed by an interior surface of the cover, the wall, and the first surface.

3. The user-worn physiological measurement device of claim 2, wherein at least a portion of the cover 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.

4. The user-worn physiological measurement device of claim 3, wherein the at least four detectors are arranged such that a first detector and a second detector of the 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 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.

5. The user-worn physiological measurement device of claim 3, wherein the at least four detectors comprise at least eight detectors.

6. The user-worn physiological measurement device of claim 5 further comprising:

a plurality of windows, wherein each of the at least four detectors has a corresponding window of the plurality of windows that allows light to pass through to the detector,

wherein each of the optical paths further;

passes through a corresponding window of the plurality of windows.

7. The user-worn physiological measurement device of claim 6, wherein the single protruding convex surface protrudes a height between 1 millimeter and 3 millimeters.

8. The user-worn physiological measurement device of claim 7, wherein the interior surface of the cover, the wall, and the first surface together hermetically seal the at least four detectors.

9. The user-worn physiological measurement device of claim 8 further comprising:

a magnet configured to be used as a connecting mechanism.

10. The user-worn physiological measurement device of claim 9 further comprising:

one or more processors configured to;

receive one or more signals from at least one of 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; and

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

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

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

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 11, wherein the displayed indicia are further responsive to temperature.

14. The user-worn physiological measurement device of claim 11, wherein the physiological parameter comprises a state or trend of wellness of the user.

15. The user-worn physiological measurement device of claim 11, 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 15, wherein the attenuated light is reflected by the tissue.

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

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

18. The user-worn physiological measurement device of claim 17, 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 plurality of windows, the one or more processors, the network interface, and the storage device.

19. The user-worn physiological measurement device of claim 18, wherein a surface of the single unit positions the touch-screen display.

20. The user-worn physiological measurement device of claim 19, wherein the strap is attached to the single unit.

21. The user-worn physiological measurement device of claim 20, wherein the network interface is configured to communicate at least the measurements of the physiological parameter to the mobile phone.

22. The user-worn physiological measurement device of claim 21, wherein the single protruding convex surface protrudes a height greater than 2 millimeters and less than 3 millimeters.

23. A physiological measurement system comprising:

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

a mobile phone in communication with the physiological measurement device.

24. A physiological measurement system comprising:

the user-worn physiological measurement device according to claim 22; and

the mobile phone in communication with the physiological measurement device.

25. The user-worn physiological measurement device of claim 1, wherein multiple of the optical paths exit different emitters and arrive at a same corresponding detector.

26. The user-worn physiological measurement device of claim 1, wherein multiple of the optical paths exit a same emitter and arrive at different corresponding detectors.

27. The user-worn physiological measurement device of claim 1, wherein each of the at least four detectors is configured to receive light that has traversed multiple of the optical paths and has exited multiple different emitters.

28. The user-worn physiological measurement device of claim 1, wherein each of the plurality of emitters is configured to emit light that traverses multiple of the optical paths and arrives at multiple different corresponding detectors.

29. A physiological measurement system comprising:

a physiological sensor device comprising;

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

at least four detectors positioned on a first surface and surrounded by a wall that is operably connected to the first surface; and

a cover operably connected to the wall and comprising a single protruding convex surface configured to be located between tissue of the user and the at least four detectors when the physiological sensor device is worn by the user,

wherein the physiological sensor device provides a plurality of optical paths, wherein each of the optical paths;

exits an emitter of the plurality of emitters,

passes through tissue of the user,

passes through the single protruding convex surface, and

arrives at a corresponding detector of the at least four detectors, the corresponding detector configured to detect light emitted by the emitter after traversal by the light of a corresponding optical path of the plurality of optical paths and after attenuation of the light by tissue of the user; and

a handheld computing device in wireless communication with the physiological sensor device, wherein the handheld computing device comprises;

one or more processors configured to wirelessly receive one or more signals from the physiological sensor device, the one or more signals responsive to at least a physiological parameter of the user;

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

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

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

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

30. The physiological measurement system of claim 29, wherein each of the optical paths further:

passes through a corresponding space formed by an interior surface of the cover, the wall, and the first surface.

31. The physiological measurement system of claim 30, wherein at least a portion of the cover 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 sensor device is worn by the user.

32. The physiological measurement system of claim 31, wherein the physiological sensor device further comprises:

a plurality of windows, wherein each of the at least four detectors has a corresponding window of the plurality of windows that allows light to pass through to the detector,

wherein each of the optical paths further;

passes through a corresponding window of the plurality of windows.

33. The physiological measurement system of claim 32, wherein the at least four detectors comprise at least eight detectors.

34. The physiological measurement system of claim 33, wherein the single protruding convex surface protrudes a height greater than 2 millimeters and less than 3 millimeters.

35. The physiological measurement system of claim 29, wherein multiple of the optical paths exit different emitters and arrive at a same corresponding detector.

36. The physiological measurement system of claim 29, wherein multiple of the optical paths exit a same emitter and arrive at different corresponding detectors.

37. The physiological measurement system of claim 29, wherein each of the at least four detectors is configured to receive light that has traversed multiple of the optical paths and has exited multiple different emitters.

38. The physiological measurement system of claim 29, wherein each of the plurality of emitters is configured to emit light that traverses multiple of the optical paths and arrives at multiple different corresponding detectors.