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

• US 10,758,166 B2
• Filed: 03/25/2020
• Issued: 09/01/2020
• 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): Liu, Chu Chuan
• Application Number:
  US16/829,578
• Publication Number:
  US 20200221980A1
• Time in Patent Office: 160 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 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:

one or more emitters configured to emit light into tissue of a user;

a first set of photodiodes arranged on a substrate, wherein;

the first set of photodiodes comprises at least four photodiodes, and

the photodiodes of the first set of photodiodes are connected to one another in parallel to provide a first signal stream;

a second set of photodiodes arranged on the substrate, wherein;

the second set of photodiodes comprises at least four photodiodes, and

the photodiodes of the second set of photodiodes are connected to one another in parallel to provide a second signal stream;

a cover comprising a protruding convex surface, wherein the protruding convex surface extends over all of the photodiodes of the first and second sets of photodiodes arranged on the substrate, and wherein at least a portion of the protruding convex surface is rigid;

one or more processors configured to;

receive a signal stream responsive to at least one of the first signal stream or the second signal stream, wherein the signal stream is responsive to at least a physiological parameter of the user; and

process the signal stream 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 first set of photodiodes, wherein the cover is above the wall and the substrate;

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 further comprising:

preprocessing electronics configured to preprocess the at least one of the first signal stream or the second signal stream before being received by the one or more processors.

3. The user-worn physiological measurement device of claim 2, wherein the preprocessing comprises adapting the at least one of the first signal stream or the second signal stream.

4. The user-worn physiological measurement device of claim 3, wherein the preprocessing further comprises amplifying the at least one of the first signal stream or the second signal stream.

5. The user-worn physiological measurement device of claim 4, wherein the preprocessing further comprises converting the at least one of the first signal stream or the second signal stream from analog to digital.

6. The user-worn physiological measurement device of claim 2, wherein the preprocessing electronics comprise at least:

a first common amplifier configured to receive the first signal stream from the first set of photodiodes at an input of the first common amplifier and at least amplify the first signal stream, and

a second common amplifier configured to receive the second signal stream from the second set of photodiodes at an input of the second common amplifier and at least amplify the second signal stream.

7. The user-worn physiological measurement device of claim 6, wherein the protruding convex surface is configured to be located between tissue of the user and the photodiodes of the first and second sets of photodiodes when the physiological measurement device is worn by the user.

8. The user-worn physiological measurement device of claim 7, wherein at least part of the protruding convex surface is light permeable to allow light to reach at least one of the photodiodes of the first or second sets of photodiodes.

9. The user-worn physiological measurement device of claim 8, wherein:

photodiodes of the first set of photodiodes and the photodiodes of the second set of photodiodes are arranged on a first surface of the substrate,

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 first set of photodiodes and the second set of photodiodes on the first surface.

10. The user-worn physiological measurement device of claim 9, wherein the physiological measurement device comprises a single unit wearable by the user, the single unit encompassing at least:

the one or more emitters, the first and second sets of photodiodes, the cover, the wall, the one or more processors, the network interface, and the storage device.

11. The user-worn physiological measurement device of claim 10, wherein a surface of the single unit positions the touch-screen display, and wherein the strap is attached to the single unit.

12. The user-worn physiological measurement device of claim 11, wherein:

the network interface is configured to communicate at least the measurements of the physiological parameter to the mobile phone, and

the network interface is further configured to wirelessly communicate with the mobile phone or with a computer network.

13. The user-worn physiological measurement device of claim 12, wherein the physiological parameter comprises at least one of:

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

14. The user-worn physiological measurement device of claim 13 further comprising:

a magnet configured to be used as a connecting mechanism.

15. The user-worn physiological measurement device of claim 14, wherein the one or more processors are further configured to modulate a duty cycle of one or more of the one or more emitters, and wherein the modulation includes pulse width time slots and off time slots.

16. The user-worn physiological measurement device of claim 13, 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.

17. The user-worn physiological measurement device of claim 13, wherein the protruding convex surface protrudes a height between 1 millimeter and 3 millimeters.

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

19. The user-worn physiological measurement device of claim 13, wherein each of the photodiodes of the first set of photodiodes and each of the photodiodes of the second set of photodiodes has a corresponding window that allows light to pass through to the photodiode.

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

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

21. The user-worn physiological measurement device of claim 13, wherein at least the photodiodes of the first set of photodiodes are arranged such that a first photodiode and a second photodiode are arranged across from each other on opposite sides of a central point along a first axis, and a third photodiode and a fourth photodiode are arranged across from each other on opposite sides of the central point along a second axis which is different from the first axis.

22. The user-worn physiological measurement device of claim 13, wherein at least one of the photodiodes is configured to receive light that has been attenuated by tissue of the user.

23. The user-worn physiological measurement device of claim 22, wherein the attenuated light is reflected by the tissue.

24. A physiological measurement system comprising:

the user-worn physiological measurement device according to claim 13; and

the mobile phone in communication with the physiological measurement device,

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.

25. A user-worn physiological measurement device comprising:

one or more emitters configured to emit light into tissue of a user;

a first set of photodiodes, the first set of photodiodes comprising at least four photodiodes, the photodiodes of the first set of photodiodes connected to one another in parallel to provide a first signal stream;

a second set of photodiodes, the second set of photodiodes comprising at least four photodiodes, the photodiodes of the second set of photodiodes connected to one another in parallel to provide a second signal stream;

one or more processors configured to;

receive a signal stream responsive to at least one of the first signal stream or the second signal stream, wherein the signal stream is responsive to at least a physiological parameter of the user; and

process the signal stream 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

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

26. The user-worn physiological measurement device of claim 25, wherein the first and second sets of photodiodes are arranged on a substrate, and wherein the user-worn physiological measurement device further comprises:

a protruding convex surface positioned above the substrate and extending over the photodiodes of the first and second sets of photodiodes.

27. The user-worn physiological measurement device of claim 26 further comprising:

preprocessing electronics comprising at least;

a first amplifier configured to receive the first signal stream at an input of the first amplifier and at least amplify the first signal stream, and

a second amplifier configured to receive the second signal stream at an input of the second amplifier and at least amplify the second signal stream.

28. The user-worn physiological measurement device of claim 27, wherein the preprocessing electronics are further configured to convert the at least one of the first signal stream or the second signal stream from analog to digital before being received by the one or more processors.

29. A user-worn physiological measurement device comprising:

one or more emitters configured to emit light into tissue of a user;

a first set of photodiodes arranged on a first surface of a substrate, wherein;

the first set of photodiodes comprises at least four photodiodes, and

the photodiodes of the first set of photodiodes are connected to one another in parallel to provide a first signal stream;

a second set of photodiodes arranged on the first surface of the substrate, wherein;

the second set of photodiodes comprises at least four photodiodes, and

the photodiodes of the second set of photodiodes are connected to one another in parallel to provide a second signal stream;

a cover comprising a protruding convex surface, wherein;

the protruding convex surface extends over all of the photodiodes of the first and second sets of photodiodes arranged on the substrate,

at least a portion of the protruding convex surface is rigid,

the protruding convex surface is configured to be located between tissue of the user and the photodiodes of the first and second sets of photodiodes when the physiological measurement device is worn by the user, and

at least part of the protruding convex surface is light permeable to allow light to reach at least one of the photodiodes of the first or second sets of photodiodes;

an at least partially opaque layer comprising windows that allow light to pass through to corresponding photodiodes of the first and second sets of photodiodes;

preprocessing electronics configured to preprocess the at least one of the first signal stream or the second signal stream, wherein the preprocessing electronics comprise at least;

a first common amplifier configured to receive the first signal stream from the first set of photodiodes at an input of the first common amplifier and at least amplify the first signal stream, and

a second common amplifier configured to receive the second signal stream from the second set of photodiodes at an input of the second common amplifier and at least amplify the second signal stream;

one or more processors configured to;

receive a signal stream responsive to at least one of the first signal stream or the second signal stream after the preprocessing of the at least one of the first signal stream or the second signal stream, wherein the signal stream is responsive to at least a physiological parameter of the user, and wherein the physiological parameter comprises at least one of;

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

process the signal stream to determine measurements of the physiological parameter;

a network interface configured to communicate at least the measurements of the physiological parameter to at least one of;

a mobile phone or a computer network;

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;

a wall that surrounds at least the first set of photodiodes, wherein;

the cover is above the wall and the substrate,

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 first set of photodiodes and the second set of photodiodes on the first surface;

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,

wherein;

the physiological measurement device comprises a single unit wearable by the user, the single unit encompassing at least;

the one or more emitters, the first and second sets of photodiodes, the cover, the wall, the one or more processors, the network interface, and the storage device,

a surface of the single unit positions the touch-screen display, and wherein the strap is attached to the single unit,

at least one of the photodiodes is configured to receive light that has been attenuated by tissue of the user, and

the attenuated light is reflected by the tissue.