U.S. patent application number 15/985672 was filed with the patent office on 2019-11-21 for glucose multi-vital-sign system in an electronic medical records system.
This patent application is currently assigned to ARC Devices Ltd.. The applicant listed for this patent is ARC Devices Limited. Invention is credited to Mark Khachaturian, Michael Smith.
Application Number | 20190350469 15/985672 |
Document ID | / |
Family ID | 67954419 |
Filed Date | 2019-11-21 |
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United States Patent
Application |
20190350469 |
Kind Code |
A1 |
Khachaturian; Mark ; et
al. |
November 21, 2019 |
Glucose Multi-Vital-Sign System in an Electronic Medical Records
System
Abstract
A device measures blood glucose levels, temperature, heart rate,
heart rate variability, respiration, SpO2, blood flow, blood
pressure, total hemoglobin (SpHb), PVi, methemoglobin (SpMet),
acoustic respiration rate (RRa), carboxyhemoglobin (SpCO), oxygen
reserve index (ORi), oxygen content (SpOC) and/or EEG of a
human
Inventors: |
Khachaturian; Mark; (Boca
Raton, FL) ; Smith; Michael; (Lakeway, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ARC Devices Limited |
|
|
|
|
|
Assignee: |
ARC Devices Ltd.
Dublin
IE
|
Family ID: |
67954419 |
Appl. No.: |
15/985672 |
Filed: |
May 21, 2018 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G06T 3/40 20130101; A61B
5/0075 20130101; A61B 5/0022 20130101; A61B 2562/0219 20130101;
A61B 5/02405 20130101; A61B 5/1495 20130101; A61B 5/01 20130101;
A61B 5/7278 20130101; A61B 5/0008 20130101; A61B 5/0816 20130101;
A61B 2562/0247 20130101; A61B 2560/0214 20130101; A61B 5/14542
20130101; A61B 5/746 20130101; A61B 5/14532 20130101; G06T 2210/22
20130101; G16H 10/60 20180101; A61B 5/0077 20130101; A61B 5/14551
20130101; A61B 5/02241 20130101; G16H 50/20 20180101; G16H 30/40
20180101; A61B 5/02055 20130101 |
International
Class: |
A61B 5/0205 20060101
A61B005/0205; A61B 5/145 20060101 A61B005/145; A61B 5/00 20060101
A61B005/00; A61B 5/01 20060101 A61B005/01; A61B 5/1455 20060101
A61B005/1455; G06T 3/40 20060101 G06T003/40; G16H 10/60 20060101
G16H010/60 |
Claims
1. An apparatus to determine a plurality of vital signs, the
apparatus comprising: a microprocessor; a wireless communication
subsystem that is operably coupled to the microprocessor and that
is configured to transmit a representation of the plurality of
vital signs, the plurality of vital signs including a temperature,
an amount of glucose and an amount of oxygen; a digital infrared
sensor that is operably coupled to the microprocessor with no
analog-to-digital converter being operably coupled between the
digital infrared sensor and the microprocessor, the digital
infrared sensor having only digital readout ports, the digital
infrared sensor having no analog sensor readout ports, the digital
infrared sensor including a Faraday cage surrounding a single
thermopile sensor and a central processing unit control block that
digitizes output of the single thermopile sensor; and a first
housing that contains the microprocessor, the wireless
communication subsystem and the digital infrared sensor; a glucose
subsystem that includes a second housing, the housing including a
source-detector assembly having a first side and a second side; the
first side having two transmitters of electromagnetic radiation in
a 375-415 nm frequency range and a 920-960 nm frequency range and a
first photodiode receiver of electromagnetic radiation in a
350-1100 nm range to measure an amount of electromagnetic radiation
that is reflected by a subject that is positioned between the first
side and the second side, wherein the microprocessor is configured
to receive from the digital readout ports a digital signal that is
representative of an infrared signal of the temperature that is
detected by the digital infrared sensor and the microprocessor is
configured to determine the plurality of vital signs from data from
the first photodiode receiver and from the digital signal that is
representative of the infrared signal in reference to a plurality
of tables that are stored in a memory that correlate the
temperature to the plurality of vital signs, a finger occlusion
cuff having a third housing; a central longitudinal axis of the
third housing of the finger occlusion cuff is not coaxial with a
central longitudinal axis of the second housing of the glucose
subsystem, wherein the second housing and the third housing are
aligned so that a finger can be inserted through the finger
occlusion cuff and into the glucose subsystem, wherein the second
housing of the glucose subsystem is mounted to the first housing,
wherein the third housing of the finger occlusion cuff is mounted
to the first housing, wherein the microprocessor is configured to
determine an indication of the amount of glucose in the subject
calculated from a ratio of electromagnetic radiation received in
the 375-415 nm frequency range in comparison to electromagnetic
radiation received in the 920-960 nm frequency range, wherein the
microprocessor is configured to determine an indication of the
amount of oxygen in the subject calculated from a ratio of
electromagnetic radiation received in a 640-680 nm frequency range
in comparison to electromagnetic radiation received in a 920-960 nm
frequency range, wherein a connection is established by the
wireless communication subsystem to an external device and the
plurality of vital signs are pushed from the apparatus through the
wireless communication subsystem, wherein the connection further
comprises an authenticated communication channel.
2. The apparatus of claim 1, wherein the first photodiode receiver
of electromagnetic radiation in the first side receives the
electromagnetic radiation in the 375-415 nm frequency range.
3. The apparatus of claim 1 further comprising a camera that is
operably coupled to the microprocessor and configured to provide a
plurality of images to the microprocessor, the microprocessor
further comprising: a cropper module that is configured to receive
the plurality of images and that is configured to crop each of the
plurality of images to exclude a border area of the images,
generating a plurality of cropped images, a
pixel-examination-module configured to examine pixel-values of the
plurality of cropped images, a temporal-variation module to
determine a temporal variation of the pixel-values between the
plurality of cropped images being below a particular threshold, a
signal processing module configured to amplify the temporal
variation resulting in an amplified-temporal-variation, and a
visualizer to visualize a pattern of flow of blood in the
amplified-temporal-variation in the plurality of images.
4. The apparatus of claim 1 wherein electromagnetic radiation in
the 375-415 nm frequency range is received by the first photodiode
receiver of electromagnetic radiation.
5. The apparatus of claim 1 further comprising: a first circuit
board including the microprocessor and a first digital interface
operably coupled to the microprocessor; and the first housing that
contains the first circuit board and that does not contain the
camera.
6. The apparatus of claim 1 wherein the wireless communication
subsystem transmits via a short distance wireless communication
path.
7-4121. (canceled)
4122. The apparatus of claim 5 further comprising: a second circuit
board in a smartphone, the smartphone having a fourth housing and
the camera; and a second digital interface, the second digital
interface being operably coupled to the first digital interface and
the second digital interface being operably coupled to the digital
infrared sensor.
Description
FIELD
[0001] This disclosure relates generally to detecting multiple
vital signs such as blood glucose levels and communicating the
detected multiple vital signs to a medical records system.
BACKGROUND
[0002] Prior techniques of capturing multiple vital signs including
blood glucose levels from human subjects have implemented
problematic sensors and have been very cumbersome in terms of
affixing the sensors to the patient, recording, analyzing, storing
and forwarding the vital signs to appropriate parties.
BRIEF DESCRIPTION
[0003] In one aspect, a device measures blood glucose levels,
temperature, heart rate, heart rate variability, respiration, SpO2,
blood flow, blood pressure, total hemoglobin (SpHb), PVi,
methemoglobin (SpMet), acoustic respiration rate (RRa),
carboxyhemoglobin (SpCO), oxygen reserve index (ORi), oxygen
content (SpOC) and/or EEG of a human.
[0004] Apparatus, systems, and methods of varying scope are
described herein. In addition to the aspects and advantages
described in this summary, further aspects and advantages will
become apparent by reference to the drawings and by reading the
detailed description that follows.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] FIG. 1 is a cross-section diagram of a multi-vital-sign
(MVS) finger cuff that determines transmissive SpO2, reflective
SpO2, reflective glucose and other vital signs such as blood
pressure, according to an implementation;
[0006] FIG. 2 is a cross-section diagram of a MVS finger cuff that
determines transmissive SpO2 and other vital signs such as blood
pressure, according to an implementation;
[0007] FIG. 3 is a cross-section diagram of a MVS finger cuff that
determines reflective SpO2 and other vital signs such as blood
pressure, according to an implementation;
[0008] FIG. 4 is a cross-section diagram of a MVS finger cuff that
determines reflective glucose and other vital signs such as blood
pressure, according to an implementation;
[0009] FIG. 5 is a cross-section diagram of a MVS finger cuff that
determines transmissive SpO2, reflective SpO2, reflective glucose
and other vital signs such as blood pressure, according to an
implementation;
[0010] FIG. 6 is a cross-section diagram of a MVS finger cuff that
determines transmissive SpO2, reflective glucose and other vital
signs such as blood pressure, according to an implementation;
[0011] FIG. 7 is a cross-section diagram of a MVS finger cuff that
determines transmissive SpO2 and reflective SpO2 and other vital
signs such as blood pressure, according to an implementation;
[0012] FIG. 8 is an isometric diagram of a MVS finger cuff in FIGS.
1-7, according to an implementation;
[0013] FIG. 9 is an exploded isometric diagram of the MVS finger
cuff in FIGS. 1-8, according to an implementation;
[0014] FIG. 10 is an exploded isometric diagram of a MVS finger
cuff in FIGS. 1-9, according to an implementation;
[0015] FIG. 11 is an exploded isometric diagram of the MVS finger
cuff in FIGS. 1-2 and 6-7;
[0016] FIG. 12 is a cross section diagram of a MVS finger cuff
accessory, according to an implementation;
[0017] FIG. 13 is an isometric diagram of a mechanical design of a
MVS finger cuff accessory, according to an implementation;
[0018] FIG. 14 is an isometric diagram of a MVS finger cuff
accessory with the topskin removed to view the interior components,
according to an implementation;
[0019] FIG. 15 is block diagram of a MVS finger cuff accessory with
the topskin removed to view the interior components, according to
an implementation;
[0020] FIG. 16 is an exploded isometric diagram of a MVS finger
cuff accessory, according to an implementation;
[0021] FIG. 17-18 are exploded isometric diagrams of the mechanical
housing of the MVS finger cuff accessory, according to an
implementation;
[0022] FIG. 19 is a block diagram of a MVS finger cuff smartphone
system, according to an implementation;
[0023] FIG. 20 is a block diagram of a front end of a MVS finger
cuff accessory, according to an implementation;
[0024] FIG. 21-27 are views of a MVS finger clip that reads
physiological light signals and other vital signs, but not blood
pressure, according to implementations;
[0025] FIG. 28 is a block diagram of a MVS smartphone, according to
an implementation;
[0026] FIG. 29 is a block diagram of a MVS smartphone, according to
an implementation;
[0027] FIG. 30 is a block diagram of a MVS smartphone system,
according to an implementation;
[0028] FIG. 31 is a block diagram of a MVS smartphone system,
according to an implementation;
[0029] FIG. 32 is a data flow diagram of the MVS smartphone,
according to an implementation;
[0030] FIG. 33 is a block diagram of a MVS smartphone system,
according to an implementation;
[0031] FIG. 34 is a block diagram of a MVS smartphone system,
according to an implementation;
[0032] FIG. 35 is a block diagram of a MVS smartphone device that
includes a digital infrared sensor, a biological vital sign
generator and a temporal motion amplifier, according to an
implementation;
[0033] FIG. 36 is a block diagram of a MVS smartphone device that
includes a no-touch electromagnetic sensor with no temporal motion
amplifier, according to an implementation;
[0034] FIG. 37 is a block diagram of a MVS smartphone device that
includes a non-touch electromagnetic sensor and that detects
biological vital-signs from images captured by a solid-state image
transducer, according to an implementation;
[0035] FIG. 38 is a block diagram of an apparatus to estimate a
body core temperature from a forehead temperature sensed by an
infrared sensor, according to an implementation;
[0036] FIG. 39-40 are block diagrams of an apparatus to derive an
estimated body core temperature from one or more tables that are
stored in a memory that correlate a calibration-corrected
voltage-corrected object temperature to the body core temperature
in reference to the corrected ambient air temperature, according to
an implementation;
[0037] FIG. 41 is a block diagram of a digital infrared sensor,
according to an implementation.
[0038] FIG. 42 is a block diagram of pneumatic system components
that are internal to the MVS finger cuff smartphone system,
according to an implementation;
[0039] FIG. 43 is a block diagram of a solid-state image
transducer, according to an implementation;
[0040] FIG. 44 is a block diagram of a communication system,
according to an implementation;
[0041] FIG. 45 is a block diagram of an apparatus to generate a
predictive analysis of vital signs, according to an
implementation;
[0042] FIG. 46 is a block diagram of an apparatus of motion
amplification, according to an implementation;
[0043] FIG. 47 is a block diagram of an apparatus of motion
amplification, according to an implementation;
[0044] FIG. 48 is a block diagram of an apparatus of motion
amplification, according to an implementation;
[0045] FIG. 49 is a block diagram of an apparatus of motion
amplification, according to an implementation;
[0046] FIG. 50 is a block diagram of an apparatus of motion
amplification, according to an implementation;
[0047] FIG. 51 is a block diagram of an apparatus of motion
amplification, according to an implementation;
[0048] FIG. 52 is a block diagram of an apparatus of motion
amplification, according to an implementation;
[0049] FIG. 53 is an apparatus that performs motion amplification
to generate biological vital signs, according to an
implementation;
[0050] FIG. 54 is a flowchart of a method of motion amplification
from which to generate and communicate biological vital signs,
according to an implementation;
[0051] FIG. 55 is a block diagram of an overview of an electronic
medical records capture system, according to an implementation;
[0052] FIG. 56 is a block diagram of a system of interoperation
device manager, according to an implementation;
[0053] FIG. 57 is a block diagram of apparatus of an EMR capture
system, according to an implementation in which an interoperability
manager component manages all communications in the middle
layer;
[0054] FIG. 58 is a flowchart of a method to perform real time
quality check on finger cuff data, according to an
implementation;
[0055] FIG. 59 is a flowchart of a method to estimate a body core
temperature from a digital infrared sensor, according to an
implementation;
[0056] FIG. 60 is a flowchart of a method to display body core
temperature color indicators, according to an implementation of
three colors;
[0057] FIG. 61 is a flowchart of a method to manage power in a MVS
smartphone system having a digital infrared sensor, according to an
implementation;
[0058] FIG. 62 is a flowchart of a method to estimate a body core
temperature from an external source point in reference to a body
core temperature correlation table, according to an
implementation;
[0059] FIG. 63 is a flowchart of a method to estimate a body core
temperature from an external source point and other measurements in
reference to a body core temperature correlation table, according
to an implementation;
[0060] FIG. 64 is a block diagram of a method of MVS detection and
communication method, according to an implementation;
[0061] FIG. 65 is a display screen of the MVS smartphone showing
results of successful MVS measurements, according to an
implementation; and
[0062] FIG. 66 is a display screen of the MVS smartphone showing
history of successful MVS measurements, according to an
implementation.
DETAILED DESCRIPTION
[0063] In the following detailed description, reference is made to
the accompanying drawings that form a part hereof, and in which is
shown by way of illustration specific implementations which may be
practiced. These implementations are described in sufficient detail
to enable those skilled in the art to practice the implementations,
and it is to be understood that other implementations may be
utilized and that logical, mechanical, electrical and other changes
may be made without departing from the scope of the
implementations. The following detailed description is, therefore,
not to be taken in a limiting sense.
[0064] The detailed description is divided into twelve sections. In
the first section, an overview is described. In the second section,
apparatus of multi-vital-sign (MVS) finger cuffs are described in
FIG. 1-11. In the third section, implementations of apparatus of
MVS finger cuff accessories are described in FIG. 12-20. In the
fourth section, implementations of apparatus of MVS finger clips
are described in FIG. 21-27. In the fifth section, implementations
of MVS smartphones are described in FIG. 28-29. In the sixth
section, implementations of MVS smartphone systems are described in
FIG. 30-34. In the seventh section, implementations of MVS devices
are described in FIG. 35-37. In the eighth section, implementations
of vital-sign components are described in FIG. 38-54. In the ninth
section, implementations of interoperability device manager
components of an EMR System are described in FIG. 55-57. In the
tenth section, methods of MVS detection and communication are
described in FIG. 58-64. In the eleventh section, implementations
of displays of MVS smartphones are described in FIG. 65-66.
Finally, in the twelfth section a conclusion of the detailed
description is provided.
1. Overview
[0065] Table 1 below shows seven implementations of physiological
light monitoring of glucose and/or SpO2 with blood pressure and
other vital-signs. In Table 1, transmissive electromagnetic
radiation (ER) is read by emitting an amount of ER at a specific
wavelength and then detecting an amount of the ER at the specific
wavelength (or within a range such as the specific wavelength.+-.20
nm) that passes through the subject. `nm` is nanometers. Reflective
ER is read by emitting an amount of ER at a specific wavelength and
then detecting an amount of the ER at that specific wavelength (or
within a range of wavelengths) that is reflected by the subject.
Measurements of ER at 395 nm are performed to determine the amount
of nitric oxide (NO) in the subject as a proxy for the amount of
glucose in the subject. Measurements of ER at 395 nm are performed
to determine the amount of oxygen in the subject. Measurements of
ER at 940 nm are performed as a baseline reference that is not
affected by oxygen or nitric oxide.
[0066] In Table 1 below, in implementation #1, transmissive SpO2 is
determined by reading transmissive ER (electromagnetic radiation)
at 660 nm and transmissive ER at 940 nm and then dividing the
amount of transmissive ER at 660 nm by the amount of transmissive
ER at 940 nm, reflective SpO2 is determined by reading reflective
ER at 660 nm and reflective ER at 940 nm and then dividing the
amount of reflective ER at 660 nm and by the amount of reflective
ER at 940 nm and the reflective glucose is determined by reading
reflective ER at 395 nm and reflective ER at 940 nm, and then
dividing the amount of reflective ER at 395 nm by the amount of
reflective ER at 940 nm.
[0067] In implementation #2, transmissive SpO2 is determined by
reading transmissive ER at 660 nm and transmissive ER at 940 nm and
then dividing the amount of transmissive ER at 660 nm by the amount
of transmissive ER at 940 nm.
[0068] In implementation #3, reflective SpO2 is determined by
reading reflective ER at 660 nm and reflective ER at 940 nm and
then dividing the amount of reflective ER at 660 nm and by the
amount of reflective ER at 940 nm. In implementation #4, reflective
glucose is determined by reading reflective ER at 395 nm and
reflective ER at 940 nm, and then dividing the amount of reflective
ER at 395 nm by the amount of reflective ER at 940 nm.
[0069] In implementation #5, reflective SpO2 is determined by
reading reflective ER at 660 nm and reflective ER at 940 nm and
then dividing the amount of reflective ER at 660 nm and by the
amount of reflective ER at 940 nm and reflective glucose is
determined by reading reflective ER at 395 nm and reflective ER at
940 nm, and then dividing the amount of reflective ER at 395 nm by
the amount of reflective ER at 940 nm. In implementation #6,
transmissive SpO2 is determined by reading transmissive ER at 660
nm and transmissive ER at 940 nm and then dividing the amount of
transmissive ER at 660 nm by the amount of transmissive ER at 940
nm and reflective glucose is determined by reading reflective ER at
395 nm and reflective ER at 940 nm, and then dividing the amount of
reflective ER at 395 nm by the amount of reflective ER at 940
nm.
[0070] In implementation #7, reflective SpO2 is determined by
reading reflective ER at 660 nm and reflective ER at 940 nm and
then dividing the amount of reflective ER at 660 nm and by the
amount of reflective ER at 940 nm and transmissive SpO2 is
determined by reading transmissive ER at 660 nm and transmissive ER
at 940 nm and then dividing the amount of transmissive ER at 660 nm
by the amount of transmissive ER at 940 nm.
[0071] In implementations that use transmissive configurations for
at least some of the measurements rather than reflective
transmissions (such as transmissive SPO2 in implementations 1, 2, 6
and 7), transmissive configurations are used because transmissive
is more accurate than reflective. Transmissive techniques have
higher accuracy because more of the signal is transmitted through
the finger than reflected, so transmissive techniques have a
stronger detected signal, and assuming the same emitted signal
strength from a signal that is reflected and a signal that is
transmitted and assuming that background ER noise is the same for
both transmissive configurations and reflective configurations, the
result is a higher signal-to-noise ratio for transmissive
techniques.
TABLE-US-00001 TABLE 1 IMPLEMENTATON DETERMINATION(S) READING(S)
DETECT(S) 1 transmissive SpO2 a) reflective 395 nm transmissive 660
nm/transmissive 940 nm reflective SpO2 b) transmissive 660 nm
reflective 660 nm/reflective 940 nm reflective glucose c)
reflective 660 nm reflective 395 nm/reflective 940 nm d)
transmissive 940 nm e) reflective 940 nm 2 transmissive SpO2 a)
transmissive 660 nm transmissive 660 nm/transmissive 940 nm b)
transmissive 940 nm 3 reflective SpO2 a) reflective 660 nm
reflective 660 nm/reflective 940 nm b) reflective 940 nm 4
reflective glucose a) reflective 395 nm reflective 395
nm/reflective 940 nm b) reflective 940 nm 5 reflective SpO2 a)
reflective 395 nm reflective 660 nm/reflective 940 nm reflective
glucose b) reflective 660 nm reflective 395 nm/reflective 940 nm c)
reflective 940 nm 6 transmissive SpO2 a) reflective 395 nm
transmissive 660 nm/transmissive 940 nm reflective glucose b)
transmissive 660 nm reflective 395 nm/reflective 940 nm c)
transmissive 940 nm d) reflective 940 nm 7 transmissive SpO2 a)
transmissive 660 nm transmissive 660/transmissive 940 nm reflective
SpO2 b) reflective 660 nm reflective 660/reflective 940 nm c)
transmissive 940 nm d) reflective 940 nm
[0072] Furthermore, the devices in FIG. 1-37 can determine within
reasonable clinical accuracy the following vital signs: blood
glucose levels, heart rate, heart rate variability, respiration
rate, SpO2, blood flow, blood pressure, total hemoglobin (SpHb),
PVi, methemoglobin (SpMet), acoustic respiration rate (RRa),
carboxyhemoglobin (SpCO), oxygen reserve index (ORi), oxygen
content (SpOC) and EEG. More specifically, heart rate, heart rate
variability, respiration rate, SpO2, blood flow, blood pressure,
total hemoglobin (SpHb), PVi, methemoglobin (SpMet), acoustic
respiration rate (RRa), carboxyhemoglobin (SpCO), oxygen reserve
index (ORi), oxygen content (SpOC) and EEG can be determined by
reading ER at 660 nm and ER at 940 nm by the PLM subsystem and then
dividing the amount of ER at 660 nm by the amount of ER at 940 nm
and then applying a transformation function that is specific to the
vital sign to the quotient of the division.
R Y = log ( I AC + I DC I DC ) Y [ nm ] log ( I AC + I DC I DC )
940 [ nm ] ##EQU00001##
[0073] where Y={660 [nm], 395 [nm]}
[0074] The relationship between R.sub.Y and the parameters, P,
below is a general transfer function T(R.sub.Y), where
Z N = { SpO 2 total hemoglobin ( SpHb ) PVi methemoglobin ( SpMet )
acoustic respiration rate ( RRa ) carboxyhemoglobin ( SpCO ) oxygen
reserve index ( ORi ) oxygen content ( SpOC ) } ##EQU00002## Z N =
T N ( R 660 , R 395 ) ##EQU00002.2##
[0075] The respiration rate and heart rate variability and the
blood pressure diastolic is estimated from data from the mDLS
sensor and the PLM subsystem. The respiration and the blood
pressure systolic is estimated from data from the mDLS sensor. The
blood flow is estimated from data from the PLM subsystem.
2. Apparatus of Multi-Vital-SignFinger Cuffs
[0076] FIGS. 1-11 are diagrams of multi-vital-sign (MVS) finger
cuffs that read physiological light signals to determine vital
signs such as blood glucose level, according to implementations.
The MVS finger cuffs in FIGS. 1-11 include a main body that is
mechanically and electrically coupled to a Physiological Light
Monitoring (PLM) subsystem. The PLM subsystem is mechanically and
electrically coupled to a finger occlusion cuff 104. In some
implementations, the PLM subsystem includes one or more emitters of
electromagnetic radiation (ER) and one or more detectors of ER
which are discussed in greater detail below.
[0077] The main body 102 includes a printed circuit board that is
mechanically and electrically coupled to a cable 108 that is
mechanically and electrically coupled to a detector of ER in a
range of 350 to 1100 nanometers (nm). ER in a range of 350 to 1100
nm includes both visible and near-infrared light. The printed
circuit board includes a microprocessor.
[0078] The finger occlusion cuff 104 includes a cuff housing 112
that surrounds a bladder tube 114 that mounts an inflatable bladder
116. Two identical collars 118 and 120 at open ends of the cuff
housing 112 position the bladder tube 114 and the inflatable
bladder 116. The MVS finger cuff 100 also includes a slide travel
122 that slideably mounts the PLM subsystem to the main body.
[0079] In FIGS. 1-37, only transmissive/transmissive or
reflective/reflective measurements are performed. In FIGS. 1-27,
reflective/transmissive measurements or transmissive/reflective
measurements are never performed because there is no usefulness to
these measurements. In implementations 1 and 4-6 in table 1 above
and in FIGS. 1 and 4-6, nitric oxide measurements that are
performed as a proxy for glucose are always reflective measurements
and never transmissive measurements because the 395 nm ER emission
that is performed to measure nitric oxide as a proxy for glucose is
visible light which will not be transmitted all the way through a
human finger.
[0080] FIG. 1 is a cross-section diagram of a multi-vital-sign
(MVS) finger cuff 100 that determines transmissive SpO2, reflective
SpO2, reflective glucose and other vital signs such as blood
pressure, according to an implementation. MVS finger cuff 100
operates in accordance with Table 1 above, in implementation #1.
MVS finger cuff 100 is particularly useful for clinical
applications.
[0081] In MVS finger cuff 100, the PLM subsystem is PLM subsystem
124 that includes an emitter in an emitter/detector 126 that emits
ER at 395 nm, 660 nm and 940 nm and that includes a detector in the
emitter/detector 126 that detects the ER in the ranges of 375-415
nm, 640-680 nm and 920-960 nm to measure ER that is reflected by
the subject finger that is positioned in the PLM subsystem 124 at
395 nm, 660 nm and 940 nm. The PLM subsystem 124 also includes an
emitter 128 that emits ER in the ranges of 640-680 nm and 920-960
nm to transmit the ER through the subject finger that is positioned
in the PLM subsystem 124 at 660 nm and 940 nm and the detector in
the emitter/detector 126 detects the ER that is emitted by the
emitter 128 at 660 nm and 940 nm and that is transmitted through
the subject finger that is positioned in the PLM subsystem 124.
[0082] A microprocessor of a printed circuit board 106 or a
microprocessor that is mounted on a printed circuit board in FIG.
18-37 determines transmissive SpO2 at 660 nm by dividing the amount
of transmissive ER at 660 nm by the amount of transmissive ER at
940 nm, reflective SpO2 is determined by dividing the amount of
reflective ER at 660 nm and by the amount of reflective ER at 940
nm and the reflective glucose is determined by dividing the amount
of reflective ER at 395 nm by the amount of reflective ER at 940
nm. MVS finger cuff 100 includes non-volatile memory such as flash
memory on the printed circuit board 106 or non-volatile memory in
the microprocessor of the printed circuit board 106.
[0083] In MVS finger cuff 100, the emitter/detector 126 includes
both an emitter and a detector so that an amount of the
electromagnetic energy that is reflected by the subject is
detected, such as the finger of the patient. The amount or level of
glucose in the blood of a subject is determined by a ratio of the
amount of ER in the 375-415 nm range that detected by the detector
in the emitter/detector 126 is divided by the amount of ER in the
920-960 nm range that detected by the emitter/detector 126, which
is then converted to units of mg/dL or mmol/L in reference to a
non-linear serpentine function. Only the amount of radiation
detected by the emitter/detector 126 in the 375-415 nm range during
the resting period of the heartbeat (in between heartbeats) is
included in the determination of the amount or level of glucose in
the blood of the subject. The resting period of the heartbeat is
determined by a ratio of the amount of ER detected in the 640-680
nm range by the emitter/detector 126 divided by the amount of
radiation detected in the 920-960 nm range by the emitter/detector
126.
[0084] FIG. 2 is a cross-section diagram of a multi-vital-sign
(MVS) finger cuff 200 that determines transmissive SpO2 and other
vital signs such as blood pressure, according to an implementation.
MVS finger cuff 200 operates in accordance with Table 1 above, in
implementation #2.
[0085] In MVS finger cuff 200, the PLM subsystem is PLM subsystem
224 that includes an emitter 226 of 660 nm ER and 940 nm ER. The
PLM subsystem 224 also includes an detector 228 that detects ER in
the ranges of 640-680 nm and 920-960 nm that is transmitted from
the emitter 226 through the subject finger that is positioned in
the PLM subsystem 224 at 660 nm and 940 nm.
[0086] The microprocessor of the printed circuit board 206 or a
microprocessor that is mounted on a printed circuit board in FIGS.
2 and 8-37 determines transmissive SpO2 at 660 nm by dividing the
amount of transmissive ER at 660 nm by the amount of transmissive
ER at 940 nm.
[0087] FIG. 3 is a cross-section diagram of a multi-vital-sign
(MVS) finger cuff 300 that determines reflective SpO2 and other
vital signs such as blood pressure, according to an implementation.
MVS finger cuff 300 operates in accordance with Table 1 above, in
implementation #3.
[0088] In MVS finger cuff 300, the PLM subsystem is PLM subsystem
324 that includes an emitter in an emitter/detector 326 that emits
ER at 660 nm and 940 nm. The emitter/detector 326 also includes a
detector that detects ER in the ranges of 640-680 nm and 920-960 nm
to measure ER that is reflected by the subject finger that is
positioned in the PLM subsystem 324 at 660 nm and 940 nm. The PLM
subsystem 324 does not include a detector on the opposite side of
the PLM subsystem from the emitter/detector 326 to detect ER that
is transmitted through the subject finger that is positioned in the
PLM subsystem.
[0089] The microprocessor of the printed circuit board 306 or a
microprocessor that is mounted on a printed circuit board in FIGS.
3 and 8-37 determines reflective SpO2 by dividing the amount of
reflective ER at 660 nm and by the amount of reflective ER at 940
nm.
[0090] FIG. 4 is a cross-section diagram of a multi-vital-sign
(MVS) finger cuff 400 that determines reflective glucose and other
vital signs such as blood pressure, according to an implementation.
MVS finger cuff 400 operates in accordance with Table 1 above, in
implementation #4.
[0091] In MVS finger cuff 400, the PLM subsystem is PLM subsystem
424 that includes an emitter in an emitter/detector 426 that emits
ER at 395 nm and 940 nm and the emitter/detector 426 also includes
a detector that detects ER in the ranges of 375-415 nm and 920-960
nm to measure ER that is reflected by the subject finger that is
positioned in the PLM subsystem 424 at 395 nm and 940 nm. The PLM
subsystem 424 does not include a detector on the opposite side of
the PLM subsystem from the emitter/detector 426 to detect ER that
is transmitted through the subject finger that is positioned in the
PLM subsystem.
[0092] The microprocessor of the printed circuit board 406 or a
microprocessor that is mounted on a printed circuit board in FIGS.
4 and 8-37 determines reflective glucose by dividing the amount of
reflective ER at 395 nm by the amount of reflective ER at 940
nm.
[0093] FIG. 5 is a cross-section diagrams of a multi-vital-sign
(MVS) finger cuff 500 that determines transmissive SpO2, reflective
SpO2, reflective glucose and other vital signs such as blood
pressure, according to an implementation. MVS finger cuff 500
operates in accordance with Table 1 above, in implementation #5.
MVS finger cuff 100 is particularly useful for non-clinical
wellness applications.
[0094] In MVS finger cuff 500, the PLM subsystem is PLM subsystem
524 that includes an emitter in an emitter/detector 526 that emits
ER at 395 nm, 660 nm and 940 nm and the emitter/detector 526
includes a detector that detects ER in the ranges of 375-415 nm,
640-680 nm and 920-960 nm to measure ER that is reflected by the
subject finger that is positioned in the PLM subsystem 524 at 395
nm, 660 nm and 940 nm. The detector in the emitter/detector 526 is
mounted on the same side of the PLM subsystem 524 as the emitter in
the emitter/detector 526 so that the detector in the
emitter/detector 526 detects an amount of the electromagnetic
energy that is reflected by the subject, such as the finger of the
patient.
[0095] The microprocessor of the printed circuit board or a
microprocessor that is mounted on a printed circuit board in FIGS.
5 and 8-37 determines reflective SpO2 by dividing the amount of
reflective ER at 660 nm and by the amount of reflective ER at 940
nm and the reflective glucose is determined by dividing the amount
of reflective ER at 395 nm by the amount of reflective ER at 940
nm.
[0096] The amount or level of glucose in the blood of a subject is
determined by a ratio of the amount of radiation detected by the
emitter/detector 526 in the 375-415 nm range divided by the amount
of radiation detected by the emitter/detector 526 in the 920-960 nm
range, which is then converted to units of mg/dL or mmol/L in
reference to a non-linear serpentine function, regardless of the
amount of radiation detected by the emitter/detector 526 in the
375-415 nm range during the resting period of the heartbeat (in
between heartbeats). All of radiation detected by the
emitter/detector 526 in the 375-415 nm range during the resting
period of the heartbeat is used in the determination of the amount
or level of glucose in the blood of the subject.
[0097] FIG. 6 is a cross-section diagram of a multi-vital-sign
(MVS) finger cuff 600 that determines transmissive SpO2, reflective
glucose and other vital signs such as blood pressure, according to
an implementation. MVS finger cuff 600 operates in accordance with
Table 1 above, in implementation #6.
[0098] In MVS finger cuff 600, the PLM subsystem is PLM subsystem
624 that includes an emitter in an emitter/detector 626 that emits
ER at 395 nm, 660 nm and 940 nm and the emitter/detector 626
includes a detector that detects ER in the ranges of 375-415 nm and
920-960 nm to measure ER that is reflected by the subject finger
that is positioned in the PLM subsystem 624 at 395 nm and 940 nm.
The PLM subsystem 624 also includes an emitter 628 that emits ER in
the ranges of 640-680 nm and 920-960 nm to transmit ER through the
subject finger that is positioned in the PLM subsystem 624 at 660
nm and 940 nm. The detector in the emitter/detector 626 detects the
ER in the ranges of 640-680 nm and 920-960 nm that is emitted by
the emitter 628.
[0099] The microprocessor of the printed circuit board 606 or a
microprocessor that is mounted on a printed circuit board in FIGS.
6 and 8-37 determines transmissive SpO2 at 660 nm by dividing the
amount of transmissive ER at 660 nm by the amount of transmissive
ER at 940 nm and the reflective glucose is determined by dividing
the amount of reflective ER at 395 nm by the amount of reflective
ER at 940 nm.
[0100] FIG. 7 is a cross-section diagram of a multi-vital-sign
(MVS) finger cuff 700 that determines transmissive SpO2 and
reflective SpO2 and other vital signs such as blood pressure,
according to an implementation. MVS finger cuff 700 operates in
accordance with Table 1 above, in implementation #1.
[0101] In MVS finger cuff 700, the PLM subsystem is PLM subsystem
724 that includes an emitter in an emitter/detector 726 that emits
ER at 660 nm and 940 nm and the emitter/detector 726 includes a
detector that detects ER in the ranges of 375-415 nm, 640-680 nm
and 920-960 nm to measure ER that is reflected by the subject
finger that is positioned in the PLM subsystem 724 at 660 nm and
940 nm. The PLM subsystem 724 also includes an emitter 728 that
emits ER in the ranges of 640-680 nm and 920-960 nm to transmit ER
through the subject finger that is positioned in the PLM subsystem
724 at 660 nm and 940 nm. The detector in the emitter/detector 726
detects the ER in the ranges of 640-680 nm and 920-960 nm that is
emitted by the emitter 628.
[0102] The microprocessor of the printed circuit board 706 or a
microprocessor that is mounted on a printed circuit board in FIGS.
7 and 8-37 determines transmissive SpO2 at 660 nm by dividing the
amount of transmissive ER at 660 nm by the amount of transmissive
ER at 940 nm and reflective SpO2 is determined by dividing the
amount of reflective ER at 660 nm and by the amount of reflective
ER at 940 nm.
[0103] FIG. 8 is an isometric diagram of a MVS finger cuff 800,
according to an implementation.
[0104] FIG. 9 is an exploded isometric diagram of the MVS finger
cuff 800, according to an implementation.
[0105] FIG. 10 is an exploded isometric diagram of the (MVS finger
cuff 700, according to an implementation. FIG. 10 shows a flexible
ribbon cable 1002 that electrically couples the PLM subsystem to
the PCB board in the main body 102 through apertures 1004 and 1006
in the slide travel 122.
[0106] In FIG. 8-10, MVS finger cuff 800 includes a slide travel
122 that slidably mounts the MVS finger cuff in FIG. 1-7 to the
main body 102, the finger occlusion cuff 104 includes the cuff
housing 112 that surrounds the bladder tube 114 that mounts the
inflatable bladder 116 and the identical collars 118 and 120 at
open ends of the cuff housing 112 position the bladder tube 114 and
the inflatable bladder 116.
[0107] FIG. 11 is an exploded isometric diagram of the MVS finger
cuff 1100 in FIGS. 1-2 and 6-7. The MVS finger cuff 1100 includes a
finger occlusion cuff 104 that includes a DLS emitter printed
circuit board 702 mounted on the interior of the bladder tube 114.
The finger occlusion cuff 104 is mounted on a main body 102, and
the main body 102 includes a cable that connects the printed
circuit board 106 to the emitter/detector 126 of FIG. 1, the
detector 228 of FIG. 2, the emitter/detector 626 of FIG. 6 and the
emitter/detector 726 of FIG. 7. A flexible ribbon cable 1102
electrically connects the emitter/detector 126 to the emitter 128
of FIG. 1, the detector 228 to the emitter 226 of FIG. 2, the
emitter/detector 626 to the emitter 628 of FIG. 6 and the
emitter/detector 726 to the emitter 728 of FIG. 7; and to the cable
108.
3. Apparatus of Multi-Vital-Sign Smartphone Accessory
[0108] FIG. 12 is a cross-section diagrams of a multi-vital-sign
finger cuff accessory (MVSFCA) that can determine transmissive
SpO2, reflective SpO2, reflective glucose and other vital signs
such as blood pressure, according to an implementation. An outer
silicon shell 1201 is a solid piece with tongues for securing into
a base of a PLM subsystem 1202, and an internal recess for a
flexible ribbon cable 1102 to fit into and the rigid parts with
components to sit in the slide travel 122. Examples of the PLM
subsystem 1202 include the PLM subsystems 124 in FIG. 1, 224 in
FIG. 2, 324 in FIG. 3, 424 in FIG. 4, 524 in FIG. 5, 624 in FIGS. 6
and 724 in FIG. 7. A translucent silicone fitting 1206, which is a
little wider than the flexible ribbon cable 1102, is positioned
over the cable/components and glued in place. The translucent
silicone fitting 1206 has shape effects 1208 in the interior to aid
in location and positioning of a finger in the PLM subsystem 1202.
The flexible ribbon cable 1102 electrically connects the
emitter/detector 1210 and an emitter 1212 to the cable 108. The
cable 108 is electrically coupled to a printed circuit board 1214.
The printed circuit board 1214 includes a microprocessor that
performs the determinations described in FIGS. 1-7 and the methods
in FIGS. 38-40, 45-54 and/or 58-64 a non-volatile memory such as
flash memory. The printed circuit board 106 of the MVS finger cuff
(such as 100, 200, 300, 400, 500, 600 or 700) is electrically
coupled to the printed circuit board 1214 of the MVSFCA 1200.
[0109] In some implementations, the MVSFCA 1200 operably couples to
a MVS smartphone via direct connect charging contacts 1924 of the
MVS finger cuff smartphone system in FIG. 19 and/or a charging port
on the end of the MVS smartphone in which the MVSFCA 1200 receives
power and control signals from the MVS smartphone and through which
data from the MVSFCA 1200 is transmitted to the MVS smartphone. In
some implementations, the MVSFCA 1200 operably couples to the MVS
smartphone via the contact charging of the MVS smartphone 3103 in
FIG. 31 or the direct connect charging contacts 1924 of the MVS
finger cuff accessory in FIG. 19 and a charging port on the back of
the MVS smartphone in which the MVSFCA 1200 receives power and
control signals from the MVS smartphone and through which data from
the MVSFCA 1200 is transmitted to the MVS smartphone. In some
implementations, the MVSFCA 1200 operably couples to the MVS
smartphone via the Bluetooth.RTM. or other wireless communication
modules of the MVSFCA 1200, such as Zigbee.RTM. or Z-Wave.RTM.. The
MVS smartphone in which the MVSFCA 1200 includes a battery and
receives control signals from the MVS smartphone and through which
data from the MVSFCA 1200 is transmitted to the MVS smartphone. The
MVS smartphone is a smartphone whose memory stores software that
causes the microprocessor of the smartphone to analyze vital sign
data from the MVSFCA 1200 and to display the vital sign data from
the MVSFCA 1200, to display the result of the analysis of vital
sign data from the MVSFCA 1200 and to transmit the vital sign data
from the MVSFCA 1200, to transmit the result of the analysis of
vital sign data from the MVSFCA 1200.
[0110] FIG. 13 is an isometric diagram of a mechanical design of a
MVS finger cuff accessory (MVSFCA) 1200, according to an
implementation. The MVSFCA 1200 can be coupled to a MVS smartphone,
such as MVS smartphone 2800 in FIG. 28, MVS smartphone 2900 in FIG.
29, MVS smartphone 3200 in FIG. 32, MVS smartphone 3004 in FIG. 30,
MVS smartphone 3103 in FIG. 31, and MVS smartphone 3402 in FIG. 34.
The MVSFCA 1200 includes a MVS finger cuff (such as 100, 200, 300,
400, 500, 600 or 700) that includes the PLM subsystem 1202 and a
finger occlusion cuff 104. Some implementations of the MVS finger
cuff accessory 1200 also include a camera and/or a digital infrared
sensor 1312. LED 1316 in the MVSFCA 1200 displays in indication of
temperature of a subject detected through the digital infrared
sensor.
[0111] FIG. 14 is an isometric diagram of a mechanical design of a
multi-vital-sign finger (MVS) cuff accessory (MVSFCA) 1200 with the
topskin removed to view the interior components, according to an
implementation. FIG. 15 is a block diagram of a MVSFCA with the
topskin removed to view the interior components, according to an
implementation. The MVSFCA 1200 includes an air pump 1402 that is
operably coupled to an air line 1404 and a pressure sensor 1406.
The MVSFCA 1200 also includes a battery 1408.
[0112] FIG. 16 is an exploded isometric diagram of a
multi-vital-sign (MVS) finger cuff accessory (MVSFCA) 1200,
according to an implementation. The MVSFCA 1200 includes a MVS
finger cuff (such as MVS finger cuff 100 in FIG. 1 or MVS finger
cuff 300 in FIG. 3) that includes a finger occlusion cuff 104. In
some implementations, the MVSFCA 1200 operably couples to the MVS
smartphone (such as MVS smartphone 3004 in FIG. 30, MVS smartphone
3103 in FIG. 31, MVS smartphone 2800 in FIG. 28 and MVS smartphone
3402 in FIG. 34) via the direct connect charging contacts 1924 of
the MVS finger cuff smartphone system in FIG. 3400 and a charging
port on the end of the MVS smartphone in which the MVSFCA 1200
receives power and control signals from the MVS smartphone and
through which data from the MVSFCA 1200 is transmitted to the MVS
smartphone. In some implementations, the MVSFCA 1200 operably
couples to the MVS smartphone via the direct connect charging
contacts 1924 of the MVS finger cuff smartphone system in FIG. 34
and a charging port on the back of the MVS smartphone in which the
MVSFCA 1200 receives power and control signals from the MVS
smartphone and through which data from the MVSFCA 1200 is
transmitted to the MVS smartphone. In some implementations, the
MVSFCA 1200 operably couples to the MVS smartphone via the
Bluetooth.RTM. or other wireless communication modules of the
MVSFCA 1200, such as Zigbee.RTM. or Z-Wave.RTM.. The MVS smartphone
in which the MVSFCA 1200 includes a battery and receives control
signals from the MVS smartphone and through which data from the
MVSFCA 1200 is transmitted to the MVS smartphone. LED 1316 in the
MVSFCA 1200 displays temperature of a subject detected through the
digital infrared sensor. The MVS smartphone is a smartphone whose
memory stores software that causes the microprocessor of the
smartphone to analyze vital sign data from the MVSFCA 1200 and to
display the vital sign data from the MVSFCA 1200, to display the
result of the analysis of vital sign data from the MVSFCA 1200 and
to transmit the vital sign data from the MVSFCA 1200, to transmit
the result of the analysis of vital sign data from the MVSFCA
1200.
[0113] The MVSFCA 1200 includes an air pump 1402 that is operably
coupled to an air line 1404, a pressure sensor 1406 and a valve
1406, that is ultimately coupled to the finger occlusion cuff 104.
The MVSFCA 1200 also includes a shield 1608 over electronic
components. The MVSFCA 1200 includes a top skin 1610, a printed
circuit board (PCB) 1612, an outer housing 1614 and a bottom skin
1616. PCB 1612 also includes an aperture 1618 and the bottom skin
1616 includes a recess 1620.
[0114] FIG. 17-18 are exploded isometric diagrams of the mechanical
housing of the multi-vital-sign (MVS) finger cuff accessory
(MVSFCA) 1200, according to an implementation.
[0115] FIG. 19 is a block diagram of a multi-vital-sign finger cuff
accessory (MVSFCA) 1900, according to an implementation. MVSFCA
1900 is one implementation of MVSFCA 3002 in FIG. 30, MVSFCA 1900
is one implementation of MVSFCA 3102 in FIG. 31, MVSFCA 1900 is one
implementation of MVSFCSS 3300 in FIG. 33 and MVSFCA 1900 is one
implementation of MVSFCSS 3404 in FIG. 34. The MVSFCA 1900
captures, stores and exports raw data from all supported sensors in
the system. MVSFCA 1900 supports a variety measurement methods and
techniques. The MVSFCA 1900 can be used in a clinical setting for
the collection of human vital signs.
[0116] A microprocessor 1902 controls and receives data from a
multi-vital-sign finger cuff 1904 (such as 100, 200, 300, 400, 500,
600 or 700), a pneumatic engine 1906, an infrared finger
temperature sensor 1908, ambient temperature sensor 1909, a
proximity sensor 1910 and another sensor 1912. In some
implementations the microprocessor 1902 is an advanced reduced
instruction set processor.
[0117] The MVS finger cuff 1904 is affixed into the MVSFCA 1900,
rather than the replaceable, detachable and removable MVS finger
cuff 3006 in FIG. 30. The MVS finger cuff 1904 includes a PLM
subsystem (such as 124, 224, 324, 424, 524, 624 or 724) and at
least one mDLS sensor. The MVS finger cuff 1904 is powered via an
air line (e.g. 3006 in FIG. 30) by the pneumatic engine 1906 that
provides air pressure to inflate the cuff bladder of the MVS finger
cuff 1904 and the that provides control signal to deflate the cuff
bladder of the MVS finger cuff 1904.
[0118] In some implementations, a body surface temperature of a
human is also sensed by the infrared finger temperature sensor 1908
that is integrated into the MVSFCA 1900 in which the body surface
temperature is collected and managed by the MVSFCA 1900.
[0119] In some implementations, a single stage measurement process
is required to measure all vital signs in one operation by the
MVSFCA 1900 by the replaceable, detachable and removable MVS finger
cuff 3006 or the MVS finger cuff 1904 or the infrared finger
temperature sensor 1908. However, in some implementations, a two
stage measurement process is performed in which the MVSFCA 1900
measures some vital signs through the replaceable, detachable and
removable MVS finger cuff 3006 or the MVS finger cuff 1904; and in
the second stage, the body surface temperature is measured through
an infrared finger temperature sensor 1908 in the MVS Smartphone
device 3103.
[0120] The MVS smartphone 3103, when connected to a wireless
Bluetooth.RTM. communication component 1916 of the MVSFCA 1900 via
a wireless Bluetooth.RTM. communication component 3114, is a slave
to the MVSFCA 1900. In other implementations, Zigbee.RTM. or
Z-Wave.RTM. can be used instead of Bluetooth.RTM.. The MVS
Smartphone 3103 reports status, measurement process, and
measurements to the user via the MVSFCA 1900.
[0121] In some implementations, the measurement process performed
by the MVSFCA 1900 is controlled and guided from the MVS Smartphone
3103 via the GUI on the MVS Smartphone 3103. The measurements are
sequenced and configured to minimize time required to complete all
measurements. In some implementations, the MVSFCA 1900 calculates
the secondary measurements of heart rate variability and blood
flow. The MVSFCA 1900 commands and controls the MVS Smartphone 3103
via a wireless Bluetooth.RTM. protocol communication path. In other
implementations, Zigbee.RTM. or Z-Wave.RTM. can be used instead of
Bluetooth.RTM.. In some further implementations, the MVS Smartphone
3103 communicates with the MVSFCA 1900, which could also be
concurrent.
[0122] MVSFCA 1900 includes a USB port 1918 that is operably
coupled to the microprocessor 1902 for interface with slave devices
only, such as the MVS Smartphone 3103, to perform the following
functions: recharge internal rechargeable batteries 1920, export
sensor data sets to a windows based computer system, firmware
update of the MVSFCA 1900 via an application to control and manage
the firmware update of the MVSFCA 1900 and configuration update of
the MVSFCA 1900.
[0123] In some implementation recharging the internal rechargeable
batteries 1920 via the USB port 1918 is controlled by a battery
power management module 1922. The battery power management module
1922 receives power from a direct connect charging contact(s) 1924
and/or a wireless power subsystem 1926 that receives power from a
RX/TX charging coil 1928. The internal rechargeable batteries 1920
of the MVSFCA 1900 can be recharged when the MVSFCA 1900 is
powered-off but while connected to USB port 1918 or DC input via
the direct connect charging contacts 1924. In some implementations,
the MVSFCA 1900 can recharge the MVS Smartphone 3103 from its
internal power source over a wireless charging connection. In some
implementations, the internal rechargeable batteries 1920 provide
sufficient operational life of the MVSFCA 1900 on a single charge
to perform at least 2 full days of measurements before recharging
of the internal rechargeable batteries 1920 of the MVSFCA 1900 is
required. In some implementations, system voltage rails 1929 are
operably coupled to the battery power management module 1922.
[0124] In some implementations, the MVSFCA 1900 includes an
internal non-volatile, non-user removable, data storage device 1930
for up to 2 full days of human raw measurement data sets. In some
implementations, the MVSFCA 1900 includes a Serial Peripheral
Interface (SPI) 1932 that is configured to connect to an eternal
flash storage system 1934.
[0125] In some implementations, the MVSFCA 1900 includes a Mobile
Industry Processor Interface (MIPI) 1936 that is operably connected
to the microprocessor 1902 and a display screen 1938. The
microprocessor 1902 is also operably coupled to the visual
indicators 1940.
[0126] The MVSFCA 1900 also includes a Wi-Fi.RTM. communication
module 1942 for communications via Wi-Fi.RTM. communication
frequencies and the MVSFCA 1900 also includes an enterprise
security module 1943 a cellular communication module 1944 for
communications via cell phone communication frequencies. The
Wi-Fi.RTM. communication module 1942 and the cellular communication
module 1944 are operably coupled to an antenna 1945 that is located
with a case/housing of the MVSFCA 1900.
[0127] The MVSFCA 1900 also includes an audio sub-system 1946 that
controls at one or more speakers 1948 to enunciate information to
an operator or patient. In some implementations, the microprocessor
1902 also controls a haptic motor 1950 through the audio sub-system
1946. User controls 1952 also control the haptic motor 1950. A
pulse-width modulator 1954 that is operably coupled to a
general-purpose input/output (GPIO) 1956 (that is operably coupled
to the microprocessor 1902) provides control to the haptic motor
1950.
[0128] The MVSFCA 1900 is hand held and portable. The MVSFCA 1900
includes non-slip/slide exterior surface material.
[0129] In some further implementations the MVSFCSS 3300 in FIG. 33
and MVSFCA 1900 in FIG. 19 perform continuous spot monitoring on a
predetermined interval with automatic transfer to remote systems
via Wi-Fi.RTM., cellular or Bluetooth.RTM. communication protocols,
with and without the use of a MVS Smartphone device, and alarm
monitoring and integration into clinical or other real time
monitoring systems, integration with the sensor box, with the
MVSFCSS acting as a hub, for third party sensors, such as ECG, or
from direct connect USB or wireless devices, e.g. Bluetooth.RTM.
patches.
[0130] In other implementations, Zigbee.RTM. or Z-Wave.RTM. can be
used instead of Bluetooth.RTM.. Wireless/network systems
(Wi-Fi.RTM., cellular 3G, 4G, 5G or Bluetooth.RTM.) are quite often
unreliable. Therefore in some implementations, the MVS Smartphone
devices and the MVSFCSS devices store vital sign measurements for
later transmission.
[0131] FIG. 20 is a block diagram of a front end of a
multi-vital-sign (MVS) finger cuff accessory 2000, according to an
implementation. The front end of a MVS finger cuff 2000 is one
implementation of a portion of a MVS finger cuff 3006 in FIG. 30.
The front end of a MVS finger cuff 2000 captures, stores and
exports raw data from all supported sensors in the system. The
front end of a MVS finger cuff 2000 supports a variety measurement
methods and techniques. The front end of a MVS finger cuff 2000 can
be used in a clinical setting for the collection of human vital
signs.
[0132] The front end of a MVS finger cuff 2000 includes a front-end
sensor electronic interface 2002 that is mechanically coupled to a
front-end subject physical interface 2004. The front-end sensor
electronic interface 2002 includes a PLM subsystem 2006 that is
electrically coupled to a multiplexer 2008 and to a PLM controller
2010. The front-end sensor electronic interface 2002 includes a
mDLS sensor 2011 that is electrically coupled to a multiplexer 2012
which is coupled to a mDLS controller 2013. The front-end sensor
electronic interface 2002 includes a mDLS sensor 2014 that is
electrically coupled to a multiplexer 2016 and mDLS controller
2017. The front-end sensor electronic interface 2002 includes an
ambient air temperature sensor 1909. The front-end sensor
electronic interface 2002 includes a 3-axis accelerator 2018.
[0133] The PLM controller 2010 is electrically coupled to a
controller 2020 through a Serial Peripheral Interface (SPI) 2022.
The mDLS controller 2013 is electrically coupled to the controller
2020 through a SPI 2024. The mDLS sensor 2014 is electrically
coupled to the controller 2020 through SPI 2026. The ambient air
temperature sensor 1909 is electrically coupled to the controller
2020 through a I2C interface 2028. The 3-axis accelerator 2018 is
electrically coupled to the controller 2020 through the I2C
interface 2028.
[0134] Visual indicator(s) 1940 are electrically coupled to the
controller 2020 through a general-purpose input/output (GPIO)
interface 2030. A serial port 2032 and a high speed serial port
2034 are electrically coupled to the controller 2020 and a serial
power interface 2036 is electrically coupled to the high speed
serial port 2034. A voltage regulator 2038 is electrically coupled
to the controller 2020. A sensor front-end test component is
electrically coupled to the controller 2020 through the GPIO
interface 2030.
[0135] A sensor cover 2048 is mechanically coupled to the PLM
subsystem 2006, a pressure finger cuff 2050 is mechanically coupled
to the front-end subject physical interface 2004 and a pneumatic
connector 2052 is mechanically coupled to the pressure finger cuff
2050.
4. Apparatus of Multi-Vital-Sign Finger Clip
[0136] FIG. 21-27 are views of a multi-vital-sign (MVS) finger clip
2100 that reads physiological light signals and other vital signs,
but not blood pressure, according to implementations.
[0137] The MVS finger clip in FIGS. 21-27 include a main body 2102
that is mechanically and electrically coupled to a Physiological
Light Monitoring (PLM) subsystem 2104. The MVS finger clip in FIGS.
21-27 does not include a finger occlusion cuff, such as finger
occlusion cuff 104 in FIG. 1-7. In some implementations, the PLM
subsystem 2104 includes one or more emitters of electromagnetic
radiation (ER) and one or more detectors of ER which are discussed
in greater detail below.
[0138] The main body 2102 includes a printed circuit board that is
mechanically and electrically coupled to a cable that is
mechanically and electrically coupled to a detector of ER in a
range of 350 to 1100 nanometers. ER in a range of 350 to 1100 nm
includes both visible and near-infrared light. The printed circuit
board includes a microprocessor. A flexible ribbon cable
electrically connects the detector and an emitter printed circuit
board to the cable.
[0139] Similar to FIG. 1-7, in FIG. 21-27, only
transmissive/transmissive or reflective/reflective measurements are
performed. In FIG. 21-27, reflective/transmissive measurements or
transmissive/reflective measurements are never performed because
there is no usefulness to these measurements. In implementations 1
and 4-6 in table 1 above and in FIG. 21-27, the nitric oxide
measurements that are performed as a proxy for glucose are always
reflective measurements and never transmissive measurements because
the 395 nm ER emission that is performed to measure nitric oxide as
a proxy for glucose is visible light which will not be transmitted
all the way through a human finger.
[0140] Some implementations of the MVS finger clip 2100 includes a
digital infrared sensor, such as digital IR sensor 1312 in FIG. 13
and FIG. 16 to measure skin surface temperature. Some
implementations of the MVS finger clip 2100 includes a thermistor
or a thermocouple to measure skin surface temperature.
[0141] In accordance with implementation #1 in Table 1 that is
particularly useful for clinical applications, the multi-vital-sign
(MVS) finger clip 2100 that determines transmissive SpO2,
reflective SpO2, reflective glucose and other vital signs but not
blood pressure, according to an implementation. In MVS finger clip
2100, the PLM subsystem 2104 includes an emitter in an
emitter/detector that emits ER at 395 nm, 660 nm and 940 nm and
that detects ER in the ranges of 375-415 nm, 640-680 nm and 920-960
nm to measure ER that is reflected by the subject finger that is
positioned in the PLM subsystem 2104 at 395 nm, 660 nm and 940 nm.
The PLM subsystem 2104 also includes a detector that detects ER in
the ranges of 640-680 nm and 920-960 nm to transmit ER through the
subject finger that is positioned in the PLM subsystem 2104 at 660
nm and 940 nm. The microprocessor of the printed circuit board or a
microprocessor that is mounted on a printed circuit board
determines transmissive SpO2 at 660 nm by dividing the amount of
transmissive ER at 660 nm by the amount of transmissive ER at 940
nm, reflective SpO2 is determined by dividing the amount of
reflective ER at 660 nm and by the amount of reflective ER at 940
nm and the reflective glucose is determined by dividing the amount
of reflective ER at 395 nm by the amount of reflective ER at 940
nm. In MVS finger clip 2100, the emitter/detector includes both an
emitter and a detector so that an amount of the electromagnetic
energy that is reflected by the subject is detected, such as the
finger of the patient. The amount or level of glucose in the blood
of a subject is determined by a ratio of the amount of ER in the
375-415 nm range that detected by the detector in the
emitter/detector is divided by the amount of ER in the 920-960 nm
range that detected by the emitter/detector, which is then
converted to units of mg/dL or mmol/L in reference to a non-linear
serpentine function. Only the amount of radiation detected by the
emitter/detector in the 375-415 nm range during the resting period
of the heartbeat (in between heartbeats) is included in the
determination of the amount or level of glucose in the blood of the
subject. The resting period of the heartbeat is determined by a
ratio of the amount of ER detected in the 640-680 nm range by the
emitter/detector divided by the amount of radiation detected in the
920-960 nm range by the emitter/detector.
[0142] In accordance with implementation #2 in Table 1, the
multi-vital-sign (MVS) finger clip 2100 that determines
transmissive SpO2 and other vital signs but not blood pressure,
according to an implementation. In MVS finger clip 2100, the PLM
subsystem 2104 includes an emitter in an emitter 226 of 660 nm ER
and 940 nm ER. The PLM subsystem 2104 also includes a detector that
detects ER in the ranges of 640-680 nm and 920-960 nm to transmit
ER through the subject finger that is positioned in the PLM
subsystem 2104 at 660 nm and 940 nm. The microprocessor of the
printed circuit board 2606 or a microprocessor that is mounted on a
printed circuit board determines transmissive SpO2 at 660 nm by
dividing the amount of transmissive ER at 660 nm by the amount of
transmissive ER at 940 nm.
[0143] In accordance with implementation #3 in Table 1, the
multi-vital-sign (MVS) finger clip 2100 that determines reflective
SpO2 and other vital signs but not blood pressure, according to an
implementation. In MVS finger clip 2100, the PLM subsystem 2104
includes an emitter in an emitter/detector that emits ER at 660 nm
and 940 nm and that detects ER in the ranges of 640-680 nm and
920-960 nm to measure ER that is reflected by the subject finger
that is positioned in the PLM subsystem 2104 at 660 nm and 940 nm.
The PLM subsystem 2104 does not include a detector on the opposite
side of the PLM subsystem 2104 from the emitter that detects ER
that is transmitted through the subject finger that is positioned
in the PLM subsystem 2104. The microprocessor of the printed
circuit board or a microprocessor that is mounted on a printed
circuit board determines reflective SpO2 by dividing the amount of
reflective ER at 660 nm and by the amount of reflective ER at 940
nm.
[0144] In accordance with implementation #4 in Table 1, the
multi-vital-sign (MVS) finger clip 2100 that determines reflective
glucose and other vital signs but not blood pressure, according to
an implementation. In MVS finger clip 2100, the PLM subsystem 2104
includes an emitter in an emitter/detector that emits ER at 395 nm
and 940 nm and that detects ER in the ranges of 375-415 nm and
920-960 nm to measure ER that is reflected by the subject finger
that is positioned in the PLM subsystem 2104 at 395 nm and 940 nm.
The microprocessor of the printed circuit board 406 or a
microprocessor that is mounted on a printed circuit board
determines reflective glucose by dividing the amount of reflective
ER at 395 nm by the amount of reflective ER at 940 nm.
[0145] In accordance with implementation #5 in Table 1 that is
particularly useful for non-clinical wellness applications, the
multi-vital-sign (MVS) finger clip 2100 that determines
transmissive SpO2, reflective SpO2, reflective glucose and other
vital signs but not blood pressure, according to an implementation.
In MVS finger clip 2100, the PLM subsystem 2104 that includes an
emitter in an emitter/detector that emits ER at 395 nm, 660 nm and
940 nm and that detects ER in the ranges of 375-415 nm, 640-680 nm
and 920-960 nm to measure ER that is reflected by the subject
finger that is positioned in the PLM subsystem 2104 at 395 nm, 660
nm and 940 nm. The detector in the emitter/detector is mounted on
the same side of the PLM subsystem 2104 as the emitter in the
emitter/detector so that the detector in the emitter/detector
detects an amount of the electromagnetic energy that is reflected
by the subject, such as the finger of the patient. The
microprocessor of the printed circuit board or a microprocessor
that is mounted on a printed circuit board determines reflective
SpO2 by dividing the amount of reflective ER at 660 nm and by the
amount of reflective ER at 940 nm and the reflective glucose is
determined by dividing the amount of reflective ER at 395 nm by the
amount of reflective ER at 940 nm. The amount or level of glucose
in the blood of a subject is determined by a ratio of the amount of
radiation detected by the emitter/detector in the 375-415 nm range
divided by the amount of radiation detected by the emitter/detector
in the 920-960 nm range, which is then converted to units of mg/dL
or mmol/L in reference to a non-linear serpentine function,
regardless of the amount of radiation detected by the
emitter/detector in the 375-415 nm range during the resting period
of the heartbeat (in between heartbeats). All of radiation detected
by the emitter/detector in the 375-415 nm range during the resting
period of the heartbeat is used in the determination of the amount
or level of glucose in the blood of the subject.
[0146] In accordance with implementation #6 in Table 1, the
multi-vital-sign (MVS) finger clip 2100 that determines
transmissive SpO2, reflective glucose and other vital signs but not
blood pressure, according to an implementation. In MVS finger clip
2100, the PLM subsystem 2104 includes an emitter in an
emitter/detector that emits ER at 395 nm, 660 nm and 940 nm and
that detects ER in the ranges of 375-415 nm and 920-960 nm to
measure ER that is reflected by the subject finger that is
positioned in the PLM subsystem 2104 at 395 nm and 940 nm. The PLM
subsystem 2104 also includes a detector that detects ER in the
ranges of 640-680 nm and 920-960 nm to transmit ER through the
subject finger that is positioned in the PLM subsystem 2104 at 660
nm and 940 nm. The microprocessor of the printed circuit board or a
microprocessor that is mounted on a printed circuit board
determines transmissive SpO2 at 660 nm by dividing the amount of
transmissive ER at 660 nm by the amount of transmissive ER at 940
nm and the reflective glucose is determined by dividing the amount
of reflective ER at 395 nm by the amount of reflective ER at 940
nm.
[0147] In accordance with implementation #7 in Table 1, the
multi-vital-sign (MVS) finger clip 2100 that determines
transmissive SpO2 and reflective SpO2 and other vital signs but not
blood pressure, according to an implementation. In MVS finger clip
2100, the PLM subsystem 2104 that includes an emitter in an
emitter/detector that emits ER at 660 nm and 940 nm and that
detects ER in the ranges of 375-415 nm, 640-680 nm and 920-960 nm
to measure ER that is reflected by the subject finger that is
positioned in the PLM subsystem 2104 at 660 nm and 940 nm. The PLM
subsystem 2104 also includes a detector that detects ER in the
ranges of 640-680 nm and 920-960 nm to transmit ER through the
subject finger that is positioned in the PLM subsystem 2104 at 660
nm and 940 nm. The microprocessor of the printed circuit board or a
microprocessor that is mounted on a printed circuit board
determines transmissive SpO2 at 660 nm by dividing the amount of
transmissive ER at 660 nm by the amount of transmissive ER at 940
nm and reflective SpO2 is determined by dividing the amount of
reflective ER at 660 nm and by the amount of reflective ER at 940
nm.
[0148] In some implementations of FIG. 1-37, the PLM subsystem
includes a single light-emitting diode structure capable of
emitting the three wavelengths required for oximetry and dye
dilution measurements. A ring counter causes three semiconductor
chips in the device to be energized in sequence. Light is directed
toward the blood sample and the reflected light is extended to
three synchronous detectors. Each detector operates only when a
corresponding semiconductor chip in the light-emitting diode is
energized; each detector thus responds only to the intensity of
light at a respective wavelength. The outputs of two of the
detectors are extended to a ratio circuit for deriving a final
measurement. The ratio circuit itself has a high accuracy over the
relatively low dynamic range of the ratio values.
[0149] In some implementations of FIG. 1-37, the PLM subsystem is
an infra-red light emitting and detecting system which has a
frequency selected for maximum light absorption by the blood. In
some implementations, the PLM subsystem uses a wavelength of
approximately 940 nm which measures the light absorption spectrum
of oxygenated blood by silicon phototransistors which have peak
response at about 940 nm, such as gallium arsenide light emitting
diodes. The wavelength (940 nm) is within the absorption spectrum
of the hydroxyl constituents of arterial blood. Some devices use
measurements of light reflection to indicate blood pulse rates. In
some implementations, the PLM subsystem measures light absorption
by the blood, using a decrease in back scatter to indicate
increased absorption, which in turn indicates increased volume of
flow. So the occurrence of each pulse is readily detected. The
energy needed in a light absorption device of the type discussed
herein is only about 1/1000 of the energy needed in the light
reflecting devices, which causes a reduction in power requirements.
In some implementations, the light-detecting photocells and the
light-emitting diodes are soldered to one side of a printed circuit
board. In some implementations, the PLM subsystem there is no
direct electrical connection between the light sources and the
detectors. In some implementations of the PLM subsystem, the light
which enters detectors does not measure the reflection of light by
the artery, but instead the back scatter which remains after the
absorption of light by the oxygenated blood in the artery and
arterioles. Each light source is an infra-red light emitting diode.
Each light emitting diode is essentially monochromatic and does not
involve the waste of white light, which has a broad frequency
spectrum. The light detectors are photocells which have high
sensitivity to the wavelength emitted by the light sources. In some
implementations, the PLM subsystem includes a single light
detecting device that is very position sensitive, i.e., their
placement is vet important because light detection efficiency is
dependent on exact location. On the other hand a plurality of
detectors eliminates positioning problems, and ensures effective
functioning of the sensor in spite of reasonable variations in its
location. In some implementations of the PLM subsystem each light
detector is physically paired with a light emitter which is the
most effective means for obtaining a reliable and consistent sensor
signal.
[0150] In some implementations of the PLM subsystem of FIG. 1-37,
light at two or more frequencies is transmitted through the finger
of a subject, and the intensity of the transmitted light is
measured on the other side of the finger, which is affected by such
variables as depth of blood in the finger and differences in the
total hemoglobin concentration in the blood. Inaccuracies caused by
these variables can be eliminated or greatly reduced by taking the
derivative of the intensity of the transmitted light, and
processing the values of these derivatives in association with a
set of predetermined pseudo coefficients by applying these to newly
developed relationships disclosed in the specification. The result
of such processing yields the value of oxygen saturation of the
blood of the subject.
[0151] In some implementations of FIG. 1-37, the apparatus includes
a circuit for the determination of the concentration of any
component of a liquid containing three different components having
different optical properties, for the determination of the
concentration sum of all components and of one other component, for
the determination of the product and of the quotient which is
formed by the third component, and for the calculation of the blood
volume per minute of the heart. One or more light sources, a light
sensing element, an optical filter and a lens are disposed in the
circuit, and also power supply circuits and control circuits. To
these are added a signal converting unit or a sensing system
operating on three wavelengths other than the isobestic points or
on a range containing these points, containing optical measurement
channels, and measuring on the transmission or reflection
principle. The signals delivered by the three-channel sensor or by
the signal converter, as the case may be, are processed by
circuits. The circuits are connected to channel amplifiers, and to
the latter are connected subtraction circuits and multiplication
circuits. By means of the electronics of suitable construction it
is possible to determine in vivo and in vitro both the change with
time of the concentration of the dye placed in the blood at any
point in the circulatory system, and the volume of the blood.
[0152] In some implementations of FIG. 1-37, the PLM subsystem
includes a wavelength range within the 700-1300 nm wavelength
range. Oxygenated hemoglobin (HbO2) which has extremely low
absorption characteristics, whereas disoxygenated hemoglobin (Hb)
displays some weak absorption which slowly rises with decreasing
wavelengths below 815 nm to a small peak in absorption around 760
nm. Because of these optical properties, the Hb-HbO.sub.2 steady
state (i.e., the venous-arterial average) can be monitored. In some
implementations, the PLM subsystem includes light shielding
associated with a light source-detector assembly which is effective
both as to extraneous near-infrared as well as extraneous ambient
light such that the light entering the body as well as the light
detected will be only those wavelengths and only from those light
sources intended to be associated with the measurements. Extraneous
photon energy at the measuring location which might otherwise enter
the body and affect the measurements is therefore desirably
absorbed by means associated with the light source-detector
assembly of the invention. Another important feature is that the
relative space between the light source and the detector elements
remain fixed during the measuring period and not be subject to
alterations by physical changes in body geometry brought about by
breathing, flexing of the body, trauma, and the like. Another
spacing important to the invention operation is the relative
spacing between the point of light entry, optical face of light
source terminal and the point of collecting the measured reflected
and scattered light (i.e. optical face) of measuring light detector
terminal. In order for the PLM subsystem to accommodate a
relatively wide range of body contours, spacing between the points
of light entry and exit can be changed. In this regard, an optical
module is formed with the light source terminal and the light
detector terminal preformed and positioned in optical module.
5. Multi-Vital-Sign Smartphones
[0153] FIG. 28 is a block diagram of a multi-vital-sign (MVS)
smartphone 2800, according to an implementation. The MVS smartphone
2800 includes a number of modules such as a main processor 2802
that controls the overall operation of the MVS smartphone 2800.
Communication functions, including data and voice communications,
can be performed through a communication subsystem 2804. The
communication subsystem 2804 receives messages from and sends
messages to wireless networks 2805. In other implementations of the
MVS smartphone 2800, the communication subsystem 2804 can be
configured in accordance with the Global System for Mobile
Communication (GSM), General Packet Radio Services (GPRS), Enhanced
Data GSM Environment (EDGE), Universal Mobile Telecommunications
Service (UMTS), data-centric wireless networks, voice-centric
wireless networks, and dual-mode networks that can support both
voice and data communications over the same physical base stations.
Combined dual-mode networks include, but are not limited to, Code
Division Multiple Access (CDMA) or CDMA2000 networks, GSM/GPRS
networks (as mentioned above), and future third-generation (3G)
networks like EDGE and UMTS. Some other examples of data-centric
networks include Mobitex.TM. and DataTAC.TM. network communication
systems. Examples of other voice-centric data networks include
Personal Communication Systems (PCS) networks like GSM and Time
Division Multiple Access (TDMA) systems.
[0154] The wireless link connecting the communication subsystem
2804 with the wireless network 2805 represents one or more
different Radio Frequency (RF) channels. With newer network
protocols, these channels are capable of supporting both circuit
switched voice communications and packet switched data
communications.
[0155] The main processor 2802 also interacts with additional
subsystems such as a Random Access Memory (RAM) 2806, a flash
memory 2808, a display 2810, an auxiliary input/output (I/O)
subsystem 2812, a data port 2814, a keyboard 2816, a speaker 2818,
a microphone 2820, short-range communications subsystem 2822 and
other device subsystems 2824. The other device subsystems 2824 can
include any one of the finger occlusion cuff 104 such as and/or the
physiological light monitoring (PLM) subsystem 124, 224, 324, 424,
524, 624 or 724 that provide signals to the biological vital sign
generator 2850. In some implementations, the flash memory 2808
includes a hybrid femtocell/Wi-Fi.RTM. protocol stack 2809. The
hybrid femtocell/Wi-Fi.RTM. protocol stack 2809 supports
authentication and authorization between the MVS smartphone 2800
into a shared Wi-Fi.RTM. network and both a 3G, 4G or 5G mobile
networks.
[0156] The MVS smartphone 2800 can transmit and receive
communication signals over the wireless network 2805 after required
network registration or activation procedures have been completed.
Network access is associated with a subscriber or user of the MVS
smartphone 2800. User identification information can also be
programmed into the flash memory 2808.
[0157] The MVS smartphone 2800 is a battery-powered device and
includes a battery interface 2832 for receiving one or more
batteries 2830. In one or more implementations, the battery 2830
can be a smart battery with an embedded microprocessor. The battery
interface 2832 is coupled to a regulator 2833, which assists the
battery 2830 in providing power V+ to the MVS smartphone 2800.
Future technologies such as micro fuel cells may provide the power
to the MVS smartphone 2800.
[0158] The MVS smartphone 2800 also includes an operating system
2834 and modules 2836 to 2850 which are described in more detail
below. The operating system 2834 and the modules 2836 to 2850 that
are executed by the main processor 2802 are typically stored in a
persistent nonvolatile medium such as the flash memory 2808, which
may alternatively be a read-only memory (ROM) or similar storage
element (not shown). Those skilled in the art will appreciate that
portions of the operating system 2834 and the modules 2836 to 2850,
such as specific device applications, or parts thereof, may be
temporarily loaded into a volatile store such as the RAM 2806.
Other modules can also be included.
[0159] The subset of modules 2836 that control basic device
operations, including data and voice communication applications,
will normally be installed on the MVS smartphone 2800 during its
manufacture. Other modules include a message application 2838 that
can be any suitable module that allows a user of the MVS smartphone
2800 to transmit and receive electronic messages. Various
alternatives exist for the message application 2838 as is well
known to those skilled in the art. Messages that have been sent or
received by the user are typically stored in the flash memory 2808
of the MVS smartphone 2800 or some other suitable storage element
in the MVS smartphone 2800. In one or more implementations, some of
the sent and received messages may be stored remotely from the MVS
smartphone 2800 such as in a data store of an associated host
system with which the MVS smartphone 2800 communicates.
[0160] The modules can further include a device state module 2840,
a Personal Information Manager (PIM) 2842, and other suitable
modules (not shown). The device state module 2840 provides
persistence, i.e. the device state module 2840 ensures that
important device data is stored in persistent memory, such as the
flash memory 2808, so that the data is not lost when the MVS
smartphone 2800 is turned off or loses power.
[0161] The PIM 2842 includes functionality for organizing and
managing data items of interest to the user, such as, but not
limited to, e-mail, contacts, calendar events, voice mails,
appointments, and task items. A PIM application has the ability to
transmit and receive data items via the wireless network 2805. PIM
data items may be seamlessly integrated, synchronized, and updated
via the wireless network 2805 with the MVS smartphone 2800
subscriber's corresponding data items stored and/or associated with
a host computer system. This functionality creates a mirrored host
computer on the MVS smartphone 2800 with respect to such items.
[0162] The MVS smartphone 2800 also includes a connect module 2844,
and an IT policy module 2846. The connect module 2844 implements
the communication protocols that are required for the MVS
smartphone 2800 to communicate with the wireless infrastructure and
any host system, such as an enterprise system, with which the MVS
smartphone 2800 is authorized to interface. Examples of a wireless
infrastructure and an enterprise system are given in FIGS. 28 and
63, which are described in more detail below.
[0163] The connect module 2844 includes a set of APIs that can be
integrated with the MVS smartphone 2800 to allow the MVS smartphone
2800 to use any number of services associated with the enterprise
system. The connect module 2844 allows the MVS smartphone 2800 to
establish an end-to-end secure, authenticated communication pipe
with the host system. A subset of applications for which access is
provided by the connect module 2844 can be used to pass IT policy
commands from the host system to the MVS smartphone 2800. This can
be done in a wireless or wired manner. These instructions can then
be passed to the IT policy module 2846 to modify the configuration
of the MVS smartphone 2800. Alternatively, in some cases, the IT
policy update can also be done over a wired connection.
[0164] The IT policy module 2846 receives IT policy data that
encodes the IT policy. The IT policy module 2846 then ensures that
the IT policy data is authenticated by the MVS smartphone 2800. The
IT policy data can then be stored in the RAM 2806 in its native
form. After the IT policy data is stored, a global notification can
be sent by the IT policy module 2846 to all of the applications
residing on the MVS smartphone 2800. Applications for which the IT
policy may be applicable then respond by reading the IT policy data
to look for IT policy rules that are applicable.
[0165] The programs 2837 can also include a
temporal-motion-amplifier 2848 and a biological vital sign
generator 2850. In some implementations, the
temporal-motion-amplifier 2848 includes a forehead
skin-pixel-identification module 4602, a frequency filter (such as
frequency filter 4606 in FIG. 46), a regional facial clusterial
module (such as regional facial clusterial module 4608 in FIG. 46)
and a frequency filter (such as frequency filter 4610 in FIGS. 46
and 47). In some implementations, the temporal-motion-amplifier
2848 includes a forehead skin-pixel-identification module (such as
forehead skin-pixel-identification module 4602 in FIG. 46), a
spatial bandpass filter (such as spatial bandpass filter 4802 in
FIG. 48), a regional facial clusterial module (such as regional
facial clusterial module 4608 in FIG. 46) and a temporal bandpass
filter (such as temporal bandpass filter 4804 in FIG. 48). In some
implementations, the temporal-motion-amplifier 2848 includes a
pixel-examiner (such as a pixel-examiner 4902 in FIG. 49), a
temporal motion determiner (such as temporal motion determiner 4906
in FIG. 49) and a signal processor (such as signal processor 4908
as in FIG. 49). In some implementations, the
temporal-motion-amplifier 2848 includes a forehead-skin pixel
identification module (such as forehead-skin pixel identification
module 5002 in FIG. 50), a frequency-filter module (such as
frequency-filter module 5008 in FIG. 50), a spatial-cluster module
(such as spatial-cluster module 5012 in FIG. 50) and a frequency
filter module (such as frequency filter module 5016 in FIGS. 50 and
52). In some implementations, the temporal-motion-amplifier 2848
includes the forehead-skin pixel identification module (such as the
forehead-skin pixel identification module 5002 in FIG. 50), a
spatial bandpass filter module (such as the spatial bandpass filter
module 5202 in FIG. 50), a spatial-cluster module (such as the
spatial-cluster module 5012 in FIG. 50) and a temporal bandpass
filter module (such as the temporal bandpass filter module 5208 in
FIG. 52). In some implementations, the temporal-motion-amplifier
2848 includes a pixel-examination-module (such as the
pixel-examination-module 5302 in FIG. 50), a temporal motion
determiner module (such as the temporal motion determiner module
5306 in FIG. 53) and a signal processing module (such as the signal
processing module 5310 in FIG. 53). Furthermore, the solid-state
image transducer 2852 captures images 2854 and the biological vital
sign generator 28502 generates the biological vital sign(s).
[0166] In some implementations, the biological vital sign generator
2850 performs the same functions as biological vital sign generator
3534 in FIG. 35 from data received from a MVSFCA in FIGS. 12-20 and
30-34 or a finger clip in FIG. 21-27. In some implementations, the
MVS smartphone 2800 includes no biological vital sign generator
2850 and the determined biological vital signs are received through
the data port 2814, the communication subsystem 2804 or the
short-range communications subsystem 2822 from a MVSFCA such as the
MVSFCAs in FIGS. 12-20 and 30-34 or the MVS finger clip in FIG.
21-27.
[0167] The biological vital sign that is generated or received is
then is displayed by display 2810 or transmitted by the
communication subsystem 2804 or the short-range communications
subsystem 2822, enunciated by the speaker 2818 or stored by the
flash memory 2808. Examples of the biological vital signs that are
displayed on the display 2810 are FIG. 65-66.
[0168] Other types of modules can also be installed on the MVS
smartphone 2800. These modules can be third party modules, which
are added after the manufacture of the MVS smartphone 2800.
Examples of third party applications include games, calculators,
utilities, etc.
[0169] The additional applications can be loaded onto the MVS
smartphone 2800 through of the wireless network 2805, the auxiliary
I/O subsystem 2812, the data port 2814, the short-range
communications subsystem 2822, or any other suitable device
subsystem 2824. This flexibility in application installation
increases the functionality of the MVS smartphone 2800 and may
provide enhanced on-device functions, communication-related
functions, or both. For example, secure communication applications
enables electronic commerce functions and other such financial
transactions to be performed using the MVS smartphone 2800.
[0170] The data port 2814 enables a subscriber to set preferences
through an external device or module and extends the capabilities
of the MVS smartphone 2800 by providing for information or module
downloads to the MVS smartphone 2800 other than through a wireless
communication network. The alternate download path may, for
example, be used to load an encryption key onto the MVS smartphone
2800 through a direct and thus reliable and trusted connection to
provide secure device communication.
[0171] The data port 2814 can be any suitable port that enables
data communication between the MVS smartphone 2800 and another
computing device. The data port 2814 can be a serial or a parallel
port. In some instances, the data port 2814 can be a USB port that
includes data lines for data transfer and a supply line that can
provide a charging current to charge the battery 2830 of the MVS
smartphone 2800.
[0172] The short-range communications subsystem 2822 provides for
communication between the MVS smartphone 2800 and different systems
or devices, without the use of the wireless network 2805. For
example, the short-range communications subsystem 2822 may include
an infrared device and associated circuits and modules for
short-range communication. Examples of short-range communication
standards include standards developed by the Infrared Data
Association (IrDA), Bluetooth.RTM., and the 802.11 family of
standards developed by IEEE. In other implementations, Zigbee.RTM.
or Z-Wave.RTM. can be used instead of Bluetooth.RTM..
[0173] Bluetooth.RTM. is a wireless technology standard for
exchanging data over short distances (using short-wavelength radio
transmissions in the ISM band from 2400-2480 MHz) from fixed and
mobile devices, creating personal area networks (PANs) with high
levels of security. Created by telecom vendor Ericsson in 1994,
Bluetooth.RTM. was originally conceived as a wireless alternative
to RS-232 data cables. Bluetooth.RTM. can connect several devices,
overcoming problems of synchronization. Bluetooth.RTM. operates in
the range of 2400-2483.5 MHz (including guard bands), which is in
the globally unlicensed Industrial, Scientific and Medical (ISM)
2.4 GHz short-range radio frequency band. Bluetooth.RTM. uses a
radio technology called frequency-hopping spread spectrum. The
transmitted data is divided into packets and each packet is
transmitted on one of the 79 designated Bluetooth.RTM. channels.
Each channel has a bandwidth of 1 MHz. The first channel starts at
2402 MHz and continues up to 2480 MHz in 1 MHz steps. The first
channel usually performs 1600 hops per second, with Adaptive
Frequency-Hopping (AFH) enabled. Originally Gaussian
frequency-shift keying (GFSK) modulation was the only modulation
scheme available; subsequently, since the introduction of
Bluetooth.RTM. 2.0+EDR, .pi./4-DQPSK and 8DPSK modulation may also
be used between compatible devices. Devices functioning with GFSK
are said to be operating in basic rate (BR) mode where an
instantaneous data rate of 1 Mb.pi./s is possible. The term
Enhanced Data Rate (EDR) is used to describe .pi./4-DPSK and 8DPSK
schemes, each giving 2 and 3 Mb.pi./s respectively. The combination
of these (BR and EDR) modes in Bluetooth.RTM. radio technology is
classified as a "BR/EDR radio". Bluetooth.RTM. is a packet based
protocol with a master-slave structure. One master may communicate
with up to 7 slaves in a piconet; all devices share the master's
clock. Packet exchange is based on the basic clock, defined by the
master, which ticks at 312.5 .mu.s intervals. Two clock ticks make
up a slot of 625 .mu.s; two slots make up a slot pair of 1250
.mu.s. In the simple case of single-slot packets the master
transmits in even slots and receives in odd slots; the slave,
conversely, receives in even slots and transmits in odd slots.
Packets may be 1, 3 or 5 slots long but in all cases the master
transmit will begin in even slots and the slave transmit in odd
slots. The devices can switch roles, by agreement, and the slave
can become the master (for example, a headset initiating a
connection to a phone will necessarily begin as master, as
initiator of the connection; but may later become a slave). The
Bluetooth.RTM. Core Specification provides for the connection of
two or more piconets to form a scatternet, in which certain devices
simultaneously play the master role in one piconet and the slave
role in another. At any given time, data can be transferred between
the master and one other device (except for the little-used
broadcast mode. The master chooses which slave device to address;
typically, the master switches rapidly from one device to another
in a round-robin fashion. Since the master chooses which slave to
address, whereas a slave is (in theory) supposed to listen in each
receive slot, being a master is a lighter burden than being a
slave. Being a master of seven slaves is possible; being a slave of
more than one master is difficult. Many of the services offered
over Bluetooth.RTM. can expose private data or allow the connecting
party to control the Bluetooth.RTM. device. For security reasons it
is necessary to be able to recognize specific devices and thus
enable control over which devices are allowed to connect to a given
Bluetooth.RTM. device. At the same time, it is useful for
Bluetooth.RTM. devices to be able to establish a connection without
user intervention (for example, as soon as the Bluetooth.RTM.
devices of each other are in range). To resolve this conflict,
Bluetooth.RTM. uses a process called bonding, and a bond is created
through a process called pairing. The pairing process is triggered
either by a specific request from a user to create a bond (for
example, the user explicitly requests to "Add a Bluetooth.RTM.
device"), or the pairing process is triggered automatically when
connecting to a service where (for the first time) the identity of
a device is required for security purposes. These two cases are
referred to as dedicated bonding and general bonding respectively.
Pairing often involves some level of user interaction; this user
interaction is the basis for confirming the identity of the
devices.
[0174] In use, a received signal such as a text message, an e-mail
message, or web page download will be processed by the
communication subsystem 2804 and input to the main processor 2802.
The main processor 2802 will then process the received signal for
output to the display 2810 or alternatively to the auxiliary I/O
subsystem 2812. A subscriber may also compose data items, such as
e-mail messages, for example, using the keyboard 2816 in
conjunction with the display 2810 and possibly the auxiliary I/O
subsystem 2812. The auxiliary I/O subsystem 2812 may include
devices such as: a touch screen, mouse, track ball, infrared
fingerprint detector, or a roller wheel with dynamic button
pressing capability. The keyboard 2816 is preferably an
alphanumeric keyboard and/or telephone-type keypad. However, other
types of keyboards may also be used. A composed item may be
transmitted over the wireless network 2805 through the
communication subsystem 2804.
[0175] For voice communications, the overall operation of the MVS
smartphone 2800 is substantially similar, except that the received
signals are output to the speaker 2818, and signals for
transmission are generated by the microphone 2820. Alternative
voice or audio I/O subsystems, such as a voice message recording
subsystem, can also be implemented on the MVS smartphone 2800.
Although voice or audio signal output is accomplished primarily
through the speaker 2818, the display 2810 can also be used to
provide additional information such as the identity of a calling
party, duration of a voice call, or other voice call related
information.
[0176] FIG. 29 is a block diagram of a MVS smartphone 2900,
according to an implementation. MVS Smartphone 2900 is one
implementation of MVS Smartphone 3004 in FIG. 30. The MVS
Smartphone 2900 includes a sensor printed circuit board (PCB) 2902.
The sensor PCB 2902 includes proximity sensors 2904, 2906 and 2908,
and temperature sensor 2910, autofocus lens 2912 in front of camera
sensor 2914 and an illumination light emitting diode (LED) 2916.
The includes proximity sensors 2904, 2906 and 2908 are operably
coupled to a first FC port 2918 of a microprocessor 2920. One
example of the microprocessor 2920 is a Qualcomm Snapdragon
microprocessor chipset. The temperature sensor 2910 is operably
coupled to a second FC port 2922 of the microprocessor 2920. The FC
standard is a multi-master, multi-slave, single-ended, serial
computer bus developed by Philips Semiconductor (now NXP
Semiconductors) for attaching lower-speed peripheral ICs to
processors and microcontrollers in short-distance, intra-board
communication. The camera sensor 2914 is operably coupled to a MIPI
port 2924 of the microprocessor 2920. The MIPI standard is defined
by the MIPI standard is defined by the MIPI Alliance, Inc. of
Piscataway, N.J. The MIPI port 2924 is also operably coupled to a
MIPI RGB bridge 2926, and the MIPI RGB bridge 2926 is operably
coupled to a display device 2928 such as a TFT Color Display
(2.8''). The illumination LED 2916 is operably coupled to a
pulse-width modulator (PWM) 2930 of the microprocessor 2920. The
PWM 2930 is also operably coupled to a haptic motor 2932. The
microprocessor 2920 also includes a GPIO port 2934, the GPIO port
2934 being a general-purpose input/output that is a generic pin on
an integrated circuit or computer board whose behavior--including
whether GPIO port 2934 is an input or output pin--is controllable
by the microprocessor 2920 at run time. The GPIO port 2934 is
operably coupled to a keyboard 2936, such as a membrane keypad
(3.times. buttons). The microprocessor 2920 is also operably
coupled to an audio codec 2938 with is operably coupled to a
speaker 2940. The microprocessor 2920 also includes a
Bluetooth.RTM. communication port 2942 and a Wi-Fi.RTM.
communication port 2944, that are both capable of communicating
with a PCB antenna 2946. In other implementations, Zigbee.RTM. or
Z-Wave.RTM. can be used instead of Bluetooth.RTM.. The
microprocessor 2920 is also operably coupled to a micro SD slot
(for debugging purposes), a flash memory unit 2950, a DDR3 random
access memory unit 2952 and a micro USB port 2954 (for debugging
purposes). The micro USB port 2954 is operably coupled to voltage
rails and a battery power/management component 2958. The battery
power/management component 2958 is operably coupled to a battery
2960, which is operably coupled to a charger connector 2962.
[0177] Biological vital signs are received through the micro USB
connector 2954, the Wi-Fi.RTM. 2944 or the Bluetooth.RTM. 2942 from
a MVSFCA such as the MVSFCAs in FIGS. 12-20 and 30-34 or the MVS
finger clip in FIG. 21-27. The biological vital signs that are
received are then displayed by display 2928 and/or transmitted by
the Wi-Fi.RTM. 2944 or the Bluetooth.RTM. 2942, enunciated by the
speaker 2940 or stored by the flash memory 2950. Examples of the
biological vital signs that are displayed on the display 2928 are
FIG. 65-66.
6. Apparatus of Multi-Vital-Sign System
[0178] FIG. 30 is a block diagram of a multi-vital-sign (MVS)
smartphone system 3000, according to an implementation. The MVS
system 3000 includes two communicatively coupled devices; a
multi-vital-sign finger cuff accessory MVSFCA 3002 and a
multi-vital-sign smartphone (MVS Smartphone) 3004. The MVSFCA 3002
includes a MVS finger cuff 3006. The MVS system 3000 is one example
of the MVS apparatus 5504. In some implementations, the MVS system
3000 captures, stores and exports raw data from all supported
sensors in the MVS finger cuff 3006. MVS system 3000 provides a
flexible human vital sign measurement methodology that supports
different measurement methods and techniques. The MVS system 3000
can be used in a clinical setting or a home setting for the
collection of human vital signs. The MVSFCA 3002 can be configured
to detect blood pressure only, SpO2 only, heart rate only,
respiration only, or any combination of vital signs that the MVSFCA
is capable of detecting. The MVS Smartphone 3004 includes
non-slip/slide exterior surface material. Heart-rate can be
determined in all devices, apparatus and methods disclosed herein
from the pulsatile component of the SpO2 measurement. The SpO2
measurement used in the determination of the heart-rate can either
transmissive SpO2 (transmissive 660 nm/transmissive 940 nm) or
reflective SpO2 (reflective 660 nm/reflective 940 nm). The number
of pulses is counted in the pulsatile component to determine the
heart-rate. Heart-rate variability can be determined in all
devices, apparatus and methods disclosed herein as the maximum
deviation time from the average heartbeat duration, in a particular
period. The deviation time is the time between any two successive
heartbeats in the particular period. The maximum deviation time is
the largest or greatest deviation of the deviation times in the
particular period. In more specific analysis of heart-rate
variability, methods such as time-domain methods, geometric
methods, frequency-domain or non-linear methods are implemented.
Respiration rate can be determined in all devices, apparatus and
methods disclosed herein from cardiac output based on pulse
analysis (from SpO2) and stroke volume (from DLS blood pressure
sensors). Cardiac output has a linear relationship with respiration
rate, as published by Wallin et al.
[0179] The MVSFCA 3002 includes a pneumatic engine 3005 and a MVS
finger cuff 3006 that are operably coupled to each other through an
air line 1404 and a communication path 3010, such as high speed
serial link A high speed serial link is especially important
because the cable of a serial link is quite a bit a bit thinner and
more flexible than a parallel cable, which provides a lighter cable
that can be more easily wrapped around the MVSFCA 3002. A cuff
bladder of the MVS finger cuff 3006 expands and contracts in
response to air pressure from the air line 1404.
[0180] Some implementations of the MVS finger cuff 3006 include a
finger occlusion cuff 3016 and a PLM subsystem 3018. The MVS finger
cuff in FIG. 1-7 are examples of the MVS finger cuff 3006. The
finger occlusion cuff 3016 and a PLM subsystem 3018 are shown in
greater detail in FIG. 1-12. In some implementations, the MVS
finger cuff 3006 includes at least one miniaturized dynamic light
scattering (mDLS) sensor and the PLM subsystem 3018. The PLM
subsystem in FIG. 1-12 is one example of the PLM subsystem 3018.
PLM subsystem 3018 and the finger occlusion cuff 3016 are operably
coupled to a common board in the MVS finger cuff 3006 and the
common board is operably coupled through the communication path
3010 to a printed circuit board that is in the base of MVSFCA
3002.
[0181] In some implementations, the MVS finger cuff 3006 integrates
the PLM subsystem and at least one miniaturized dynamic light
scattering (mDLS) sensor into a single sensor. Both of the which
are attached to the MVS finger cuff 3006. The PLM and mDLS
implementation of the MVS finger cuff 3006 measures the following
primary and secondary human vital sign measurements through a PLM
subsystem from either an index finger or a middle finger; on both
the left or right hands at heart height to ensure an accurate
measurement: Primary human vital sign measurements such as blood
pressure (diastolic and systolic), SpO2, heart rate and respiration
rate. Secondary human vital sign measurements include heart rate
variability and blood flow. The PLM subsystem optically measures
light that passes through tissue from at least one IR light
emitters. The PLM subsystem includes one infrared detector that
detects infrared energy at two different transmitted wavelengths;
red and near infrared. Signal fluctuations of the light are
generally attributed to the fluctuations of the local blood volume
due to the arterial blood pressure wave, which means that the
amount of blood in the illuminated perfused tissue fluctuates at
the rate of heartbeats. So does the light transmission or light
refraction. Therefore, PLM data is an indirect method of the
estimation of the blood volume changes. The blood pressure is
estimated from data from the mDLS sensor in conjunction with a
blood pressure finger cuff which mimics pressure cycle to create an
occlusion like the arm cuff. The biological target is illuminated
by a laser, the signal is collected by a detector and the time
dependency of the laser speckle characteristics are analyzed. The
mDLS geometry is designed to create direct signal scattering
reflection of the signal into the detector. Each mDLS sensor
includes two photo diode receivers and one laser transmitter.
[0182] In some implementations, the MVS finger cuff 3006 is
replaceable, detachable and removable from the MVSFCA 3002. In some
implementations, the MVS finger cuff 3006 is integrated into the
MVSFCA 3002. The MVS finger cuff 300 that is replaceable,
detachable and removable from the MVSFCA 3002 is beneficial in two
ways: 1) the MVS finger cuff 3006 is replaceable in the event of
damage 2) the MVS finger cuff 3006 can be detached from the MVSFCA
3002 and then attached to a custom connector cable (pneumatic and
electrical) that allows a patient to wear the MVS finger cuff 3006
for continuous monitoring, and (3) servicing the device. The
replaceable MVS finger cuff 3006 can have photo optic component(s)
(e.g. 2.times. mDLS) that are cleanable between patients and
replaceable in the event of failure of the inflatable cuff or the
photo optic component(s). In some implementations, the cuff bladder
of the removable MVS finger cuff 3006 is translucent or transparent
to transparent to the mDLS laser wavelengths and which in some
implementations allows the position of the MVS finger cuff 3006 to
be adjusted in relation to specific parts of human anatomy for
optimal function of the sensors and comfort to the patient.
[0183] The MVSFCA 3002 and the MVS Smartphone 3004 can be operably
coupled to each other through a communication path 3012 to exchange
data and control signals and a 4 point electrical recharge
interface (I/F) line 3014 recharge from a conventional wall outlet.
In some implementations, the 4 point electrical recharge interface
(I/F) line 3014 is a 3 point electrical recharge interface (I/F)
line. The MVSFCA 3002 and the MVS Smartphone 3004 do not need to be
physically attached to each other for measurement operation by
either the MVSFCA 3002 or the MVS Smartphone 3004. In some
implementations, the MVSFCA 3002 has at least one universal serial
bus (USB) port(s) for bi-directional communication, command,
control, status and data transfer with another devices with both
standard and propriety protocols using USB infrastructure. USB
protocol is defined by the USB Implementers Forum at 5440 SW
Westgate Dr. Portland Oreg. 94221. In some implementations, the MVS
Smartphone 3004 has at least one USB port(s) for communication with
other devices via USB, such as connected to a MVSFCA 3002 for the
purposes of transferring the raw sensor data from the device to a
computer for analysis. Biological vital signs are received by MVS
Smartphone 3004 through the Bluetooth.RTM. link 3012 from a MVSFCA
such as in FIG. 12-20 or a MVS finger cuff in FIG. 21-27 in FIG.
12-20 or the MVS finger clip in FIG. 21-27. The biological vital
signs that are received are then displayed by display 2928 an/or
transmitted by the Wi-Fi@ 2944 or the Bluetooth.RTM. 2942,
enunciated by the speaker 2940 or stored by the flash memory 2950.
Examples of the biological vital signs that are displayed on the
display 2928 are FIG. 65-66. In other implementations, Zigbee.RTM.
or Z-Wave.RTM. can be used instead of Bluetooth.RTM..
[0184] FIG. 31 is a block diagram of a MVS smartphone system 3100,
according to an implementation. The MVS smartphone system 3100
includes three communicatively coupled devices; a MVS finger cuff
accessory (MVSFCA) 3102, a multi-vital-sign smartphone (MVS
Smartphone) 3103 and a multi-vital-sign finger cuff accessory
Recharge Station (MVSFCARS) 3104. MVSFCA 3102 is one implementation
of MVSFCA 3002 in FIG. 30. MVS Smartphone 3103 is one
implementation of MVS Smartphone 3004 in FIG. 30. The MVS
smartphone system 3100, the MVSFCA 3102 and the MVS Smartphone 3103
are all examples of the MVS apparatus 5504. The MVS Smartphone 3103
captures, stores and exports raw data from all supported sensors in
the system. More specifically, the MVS Smartphone 3103 extracts and
displays vital signs and transfers the vital-signs to either a
remote third party, hub, bridge etc., or a device manager, or
directly to remote EMR/HER/Hospital systems or other third party
local or cloud based systems. MVS smartphone system 3100 provides a
flexible human vital sign measurement methodology that supports
different measurement methods and techniques. The MVS smartphone
system 3100 can be used in a clinical setting for the collection of
human vital signs.
[0185] Some implementations of the MVSFCA 3102 include a MVS finger
cuff 1904 that is fixed into the MVSFCA 3102, rather than the
replaceable, detachable and removable MVS finger cuff 3006 in FIG.
30. The MVS finger cuff 1904 includes a PLM subsystem and at least
one mDLS sensor. The MVS finger cuff 1904 is powered via an air
line (e.g. 1404 in FIG. 30) by a pneumatic engine 1906 that
provides air pressure to inflate the cuff bladder of the MVS finger
cuff 1904 and the controlled release of that pressure. In some
implementations, the air line 1404 is 1/6'' (4.2 mm) in diameter.
The MVS finger cuff 1904 in FIGS. 31 and 33 is the same as the MVS
finger cuffs in FIGS. 1-11 and 34.
[0186] In some implementations, a body surface temperature of a
human is also sensed by an infrared finger temperature sensor 1908
that is integrated into the MVSFCA 3102 in which the body surface
temperature is collected and managed by the MVSFCA 3102. One
example of the pneumatic engine 1906 is the pneumatic engine 3005
and the pneumatic system components 4200 in FIG. 42.
[0187] In some implementations, a single stage measurement process
is required to measure all vital signs in one operation by the MVS
Smartphone 3103 by the replaceable, detachable and removable MVS
finger cuff 3006 or the MVS finger cuff 1904 or the infrared finger
temperature sensor 1908. However, in some implementations, a two
stage measurement process is performed in which the MVSFCA 3102
measures some vital signs through the replaceable, detachable and
removable MVS finger cuff 3006 or the MVS finger cuff 1904; and in
the second stage, the body surface temperature is measured through
an infrared finger temperature sensor 1908 in the MVS Smartphone
device 3103. One implementation of the infrared finger temperature
sensor 1908 is digital infrared sensor 1312 in FIG. 41.
[0188] The MVSFCA 3102 operates in two primary modes, the modes of
operation based on who takes the measurements, a patient or an
operator. The two modes are: 1) Operator Mode in which an operator
operates the MVSFCA 3102 to take a set of vital sign measurements
of another human. The operator is typically clinical staff or a
home care giver. 2) Patient Mode in which a patient uses the MVSFCA
3102 to take a set of vital sign measurements of themselves. In
some implementations, the MVSFCA 3102 provides both the main
measurement modes for patient and operator. The primary measurement
areas on the human to be measured are 1) Left hand, index and
middle finger, 2) right hand, index and middle finger, and 3) human
forehead temperature (requires the other device to perform
temperature measurement). The MVSFCA 3102 is portable, light
weight, hand held and easy to use in primary and secondary modes of
operation in all operational environments.
[0189] Given the complex nature of integration into hospital
networks, in some implementations, in some implementations the
MVSFCA 3102 does not include site communication infrastructure,
rather the collected data (vital sign) is extracted from the MVSFCA
3102 via a USB port or by a USB mass storage stick that is inserted
into the MVSFCA 3102 or by connecting the MVSFCA 3102 directly to a
PC system as a mass storage device itself.
[0190] The MVS smartphone 3103, when connected to a wireless
Bluetooth.RTM. communication component 1916 of the MVSFCA 3102 via
a wireless Bluetooth.RTM. communication component 3114, can be a
slave to the MVSFCA 3102. The MVS Smartphone 3103 reports status,
measurement process, and measurement measurements to the user via
the MVSFCA 3102. The MVS Smartphone 3103 provides a user input
method to the MVSFCA 3102 via a graphical user interface on a LCD
display 3116 which displays data representative of the measurement
process and status. In one implementation, the wireless
Bluetooth.RTM. communication component 1916 of the MVSFCA 3102
includes communication capability with cellular communication paths
(3G, 4G and/or 5G) and/or Wi-Fi.RTM. communication paths and the
MVSFCA 3102 is not a slave to the captures vital sign data and
transmits the vital sign data via the wireless Bluetooth.RTM.
communication component 1916 in the MVSFCA 3102 to the middle layer
5506 in FIG. 55 or the MVS Smartphone 3103 transmits the vital sign
data via the communication component 3117 of the MVS Smartphone
3103 to the bridge 5520, a Wi-Fi.RTM. access point, a cellular
communications tower, a bridge 5520 in FIG. 55. In other
implementations, Zigbee.RTM. or Z-Wave.RTM. can be used instead of
Bluetooth.RTM..
[0191] In some implementations, the MVS Smartphone 3103 provides
communications with other devices via a communication component
3117 of the MVS Smartphone 3103. The communication component 3117
has communication capability with cellular communication paths (3G,
4G and/or 5G) and/or Wi-Fi.RTM. communication paths. For example,
the MVSFCA 3102 captures vital sign data and transmits the vital
sign data via the wireless Bluetooth.RTM. communication component
1916 in the MVSFCA 3102 to the wireless Bluetooth.RTM.
communication component 3114 in the MVS Smartphone 3103, and the
MVS Smartphone 3103 transmits the vital sign data via the
communication component 3117 of the MVS Smartphone 3103 to the
middle layer 5506 in FIG. 55 or the MVS Smartphone 3103 transmits
the vital sign data via the communication component 3117 of the MVS
Smartphone 3103 to the bridge 5520, a Wi-Fi.RTM. access point, a
cellular communications tower, a bridge 5520 in FIG. 55.
[0192] In some implementations, when the MVS Smartphone 3103 is
connected to the MVSFCA 3102, the MVS Smartphone 3103 performs
human bar code scan by a bar code scanner 3118 or identification
entry as requested by MVSFCA 3102, the MVS Smartphone 3103 performs
an operator bar code scan or identification entry as requested by
MVSFCA 3102, the MVS Smartphone 3103 performs human temperature
measurement as requested by MVSFCA 3102, the MVS Smartphone 3103
displays information that is related to the MVSFCA 3102 direct
action, the MVS Smartphone 3103 starts when the MVSFCA 3102 is
started, and the MVS Smartphone 3103 is shutdown under the
direction and control of the MVSFCA 3102, and the MVS Smartphone
3103 has a self-test mode that determines the operational state of
the MVSFCA 3102 and sub systems, to ensure that the MVSFCA 3102 is
functional for the measurement. In other implementations, when the
MVS Smartphone 3103 is connected to the MVSFCA 3102, the MVS
Smartphone 3103 performs human bar code scan or identification
entry as requested by MVS Smartphone 3103, the MVS Smartphone 3103
performs an operator bar code scan or identification entry as
requested by MVS Smartphone 3103, the MVS Smartphone 3103 performs
human temperature measurement as requested by MVS Smartphone 3103
and the MVS Smartphone 3103 displays information that is related to
the MVSFCA 3102 direct action. In some implementations, the
information displayed by the MVS Smartphone 3103 includes
date/time, human identification number, human name, vitals
measurement such as blood pressure (diastolic and systolic), SpO2,
heart rate, temperature, respiratory rate, MVSFCA 3102 free memory
slots, battery status of the MVS Smartphone 3103, battery status of
the MVSFCA 3102, device status of the MVSFCA 3102, errors of the
MVS Smartphone 3103, device measurement sequence, measurement
quality assessment measurement, mode of operation, subject and
operator identification, temperature, measurement, display mode and
device revision numbers of the MVS Smartphone 3103 and the MVSFCA
3102. In some implementations, when a body surface temperature of a
human is also sensed by an infrared sensor in the MVS smartphone
3103, the body surface temperature is collected and managed by the
MVSFCA 3102. In other implementations, when a body surface
temperature of a human is sensed by an infrared sensor in the MVS
smartphone 3103, the body surface temperature is not collected and
managed by the MVSFCA 3102.
[0193] In some implementations, the multi-vital-sign finger cuff
accessory (MVSFCA) 3102 includes the following sensors and sensor
signal capture and processing components that are required to
extract the required primary and secondary human vital signs
measurements: the MVS finger cuff 1904 that includes a PLM
subsystem and two mDLS sensors, the infrared finger temperature
sensor 1908 and an ambient air temperature sensor 1909, and in some
further implementation, non-disposable sensors for other human
measurements. In some implementations, data sample rates for PLM
subsystem is 2.times.200 Hz.times.24 bit=9600 bits/sec, for each of
the mDLS sensors is 32 kHz.times.24 bit=1,572,864 b.pi./sec and for
the ambient air temperature sensor is less than 1000 bps. Two mDLS
sensors are included in the MVSFCA 3102 to ensure that one or both
sensors delivers a good quality signal, thus increasing the
probability of obtaining a good signal from a mDLS sensor.
[0194] The MVS Smartphone 3103 performs concurrent two stage
measurement processes for all measurements. The measurement process
performed by the MVS Smartphone 3103 is controlled and guided from
the MVS Smartphone 3103 via the GUI on the MVSFCA 3102. The
measurements are sequenced and configured to minimize time required
to complete all measurements. In some implementations, the MVS
Smartphone 3103 calculates the secondary measurements of heart rate
variability and blood flow. The MVS Smartphone 3103 commands and
controls the MVSFCA 3102 via a wireless Bluetooth.RTM. protocol
communication path 3012 and in some further implementations, the
MVSFCA 3102 communicates to other devices through Bluetooth.RTM.
protocol communication line (not shown), in addition to the
communications with the MVS Smartphone 3103 which could also be
concurrent. in some further implementations, the MVS Smartphone
3103 communicates to other devices through Bluetooth.RTM. protocol
communication line (not shown), in addition to the communications
with the MVSFCA 3102 device, which could also be concurrent.
[0195] MVSFCA 3102 includes a USB port 1918 for interface with the
MVS Smartphone 3103 only, such as the MVS Smartphone 3103, to
perform the following functions: recharge the internal rechargeable
batteries 1920 of the MVSFCA 3102, export sensor data sets to a
windows based computer system, firmware update of the MVSFCA 3102
via an application to control and manage the firmware update of the
MVSFCA 3102 and configuration update of the MVSFCA 3102. The MVSFCA
3102 does not update the MVS Smartphone 3103 firmware. The MVSFCA
3102 also includes internal rechargeable batteries 1920 that can be
recharged via a USB port 3122, which transmits charge, and the
MVSFCA 3102 also includes an external direct DC input providing a
fast recharge. The internal batteries of the MVSFCA 3102 can be
recharged when the MVSFCA 3102 is powered-off but while connected
to USB or DC input. In some implementations, the MVSFCA 3102 can
recharge the MVS Smartphone 3103 from its internal power source
over a wireless charging connection. In some implementations, the
internal rechargeable batteries 1920 provide sufficient operational
life of the MVSFCA 3102 on a single charge to perform at least 2
days of full measurements before recharging of the internal
rechargeable batteries 1920 of the MVSFCA 3102 is required.
[0196] In some implementations, the MVSFCA 3102 includes an
internal non-volatile, non-user removable, data storage device 1930
for up to 20 human raw measurement data sets. The data storage
device 1930 can be removed by a technician when the data storage
device 1930 is determined to be faulty. A human measurement set
contains all measurement data and measurements acquired by the
MVSFCA 3102, including the temperature measurement from the MVS
Smartphone 3103. The internal memory is protected against data
corruption in the event of an abrupt power loss event. The MVSFCA
3102 and the MVS Smartphone 3103 have a human-form fit function
sensor and device industrial/mechanical design. The MVSFCA 3102
also includes anti-microbial exterior material to and an easy clean
surface for all sensor and device surfaces. The MVSFCA 3102 stores
in the data storage device 1930 an "atomic" human record structure
that contains the entire data set recording for a single human
measurement containing all human raw sensor signals and readings,
extracted human vitals, and system status information. The MVSFCA
3102 includes self-test components that determine the operational
state of the MVSFCA 3102 and sub systems, to ensure that the MVSFCA
3102 is functional for measurement. The MVSFCA 3102 includes a
clock function for date and time. In some implementations. The date
and time of the MVSFCA 3102 is be updated from the MVS Smartphone
3103. In some implementations, the MVSFCA 3102 includes user input
controls, such as a power on/off switch (start/stop), an emergency
stop control to bring the MVS finger cuff to a deflated condition.
In some implementations, all other input is supported via the MVS
Smartphone 3103 via on screen information of the MVS Smartphone
3103. In some implementations, the MVSFCA 3102 includes visual
indicators 1940 such as a fatal fault indicator that indicates
device has failed and will not power up, a device fault indicator
(that indicates the MVSFCA 3102 has a fault that would affect the
measurement function), battery charging status indicator, battery
charged status indicator, a battery fault status indicator.
[0197] The components (e.g. 1904, 1906, 1908, 1909, 1916, 1918,
1920, 3122, 1930 and 1940) in the MVSFCA 3102 are controlled by a
control process and signal processing component 3127. The control
process and signal processing component can implemented by a
microprocessor or by a FPGA.
[0198] The multi-vital-sign finger cuff accessory Recharge Station
(MVSFCARS) 3104, provides electrical power to recharge the MVSFCA
3102. The MVSFCARS 3104 can provide electrical power to recharge
the batteries of the MVSFCA 3102 either via a physical wired
connection or via a wireless charger 3130. In some implementations,
the MVSFCARS 3104 does not provide electrical power to the MVSFCA
3102 because the MVSFCA 3102 includes internal rechargeable
batteries 1920 that can be recharged via either USB port 3122 or a
DC input.
[0199] MVS Smartphone 3103 includes a connection status indicator
(connected/not connected, fault detected, charging/not charging), a
connected power source status indicator, (either USB or DC input)
and a power On/Off status indicator. The visual indicators are
visible in low light conditions in the home and clinical
environment.
[0200] The MVSFCA 3102 is hand held and portable. The MVSFCA 3102
includes non-slip/slide exterior surface material.
[0201] Vital signs are received through the wireless Bluetooth.RTM.
communication component 3114 from a MVSFCA such as the MVSFCAs in
FIGS. 12-20 and 30-34 or the MVS finger clip in FIG. 21-27. The
vital signs that are received are then displayed by LCD display
3116 and/or transmitted by the communication component 3117,
enunciated by a speaker or stored by a flash memory. Examples of
the biological vital signs that are displayed on the display 3116
are FIG. 65-66.
[0202] FIG. 32 is a data flow diagram 3200 of the MVS smartphone
3103, according to an implementation. Data flow diagram 3200 is a
process of the MVSFCA 3102 via a graphical user interface on a LCD
display 3116 on the MVS smartphone device 3103.
[0203] In data flow diagram 3200, a main screen 3202 is displayed
by the MVS Smartphone device 3103 that provides options to exit the
application 3204, display configuration settings 3206, display data
export settings 3208 or display patient identification entry screen
3210. The configuration settings display 3206 provides options for
the configuration/management of the MVS Smartphone device 3103. In
some implementations, the data flow diagram 3200 includes low power
operation and sleep, along startup, initialization, self check and
measurement capability of the MVS Smartphone device 3103. The
display of data export settings 3208 provides options to take
individual measurement of a given vital sign. After the patient
identification entry screen 3210 or and alternatively, bar code
scanning of both operator and subject, has been completed, one or
more sensors are placed on the patient 3212, the MVS Smartphone
device 3103 verifies 3214 that signal quality from the sensors is
at or above a predetermined minimum threshold. If the verification
3214 fails 3216 as shown in FIG. 65, then the process resumes where
one or more sensors are placed on the patient 3212. If the
verification 3214 succeeds 3218 as shown in FIG. 66, then
measurement 3220 using the one or more sensors is performed and
thereafter the results of the measurements are displayed 3222 as
shown in FIG. 38 and thereafter the results of the measurements are
saved to EMR or clinical cloud 3224, and then the process continues
at the main screen 3202. The "para n done" actions the measurement
3220 are indications that the sensing of the required vital-signs
is complete. Examples of the measurements 3220 that are displayed
3222 are FIG. 65-66.
[0204] FIG. 33 is a block diagram of a multi-vital-sign finger cuff
smartphone system (MVSFCSS) 3300, according to an implementation.
MVSFCSS 3300 is one implementation of MVSFCA 3002 in FIG. 30 and
MVSFCSS 3300 is one implementation of MVSFCA 3102 in FIG. 31. The
MVSFCSS 3300 captures, stores and exports raw data from all
supported sensors in the system. MVSFCSS 3300 supports a variety
measurement methods and techniques. The MVSFCSS 3300 can be used in
a clinical setting for the collection of human vital signs.
[0205] A sensor management component 3302 controls and receives
data from a MVS finger cuff 1904, a pump, valve, and pressure
sensor (shown in FIG. 42) an infrared finger temperature sensor
1908, a proximity sensor 1910 and another sensor 1912. The sensor
management component 3302 can be implemented in the control process
and signal processing component 3127 in FIG. 31, which can be
implemented by a microprocessor or by a FPGA.
[0206] MVSFCSS 3300 also includes a CMOS camera 3308 that is
operably coupled to a USB port 3304. The CMOS camera captures
images that are processed for reading a barcode to identify the
patient and by motion amplification components for determining
heart rate, respiratory rate, and blood pressure, a lens 3310 is
coupled to the CMOS camera 3308.
[0207] The MVS finger cuff 1904 is integrated into the MVSFCSS
3300, rather than the replaceable, detachable and removable MVS
finger cuff 3006 in FIG. 30. The MVS finger cuff 1904 includes a
PLM subsystem and at least one mDLS sensor. The MVS finger cuff
1904 is powered via an air line (e.g. 1404 in FIG. 30) by the
pneumatic engine 1906 that provides air pressure to inflate and
deflate the cuff bladder of the MVS finger cuff 1904 and real time
measurement.
[0208] In some implementations, a body surface temperature of a
human is also sensed by the infrared finger temperature sensor 1908
that is integrated into the MVSFCSS 3300 in which the body surface
temperature is collected and managed by the MVSFCSS 3300.
[0209] In some implementations, a single stage measurement process
is required to measure all vital signs in one operation by the
MVSFCSS 3300 by the replaceable, detachable and removable MVS
finger cuff 3006 or the MVS finger cuff 1904 or the infrared finger
temperature sensor 1908. However, in some implementations, a two
stage measurement process is performed in which the MVSFCSS 3300
measures some vital signs through the replaceable, detachable and
removable MVS finger cuff 3006 or the MVS finger cuff 1904; and in
the second stage, the body surface temperature is measured through
an infrared finger temperature sensor 1908 in the MVS Smartphone
device 3103.
[0210] The MVSFCSS 3300 operates in two primary modes, the modes of
operation based on who takes the measurements, a patient or an
operator. The two modes are: 1) Operator Mode in which an operator
operates the MVSFCSS 3300 to take a set of vital sign measurements
of another human The operator is typically clinical staff or a home
care giver. 2) Patient Mode in which a patient uses the MVSFCSS
3300 to take a set of vital sign measurements of themselves. In
some implementations, the MVSFCSS 3300 provides both the main
measurement modes for patient and operator. The primary measurement
areas on the human to be measured are 1) face 2) forehead 3) Left
hand, index and middle finger and 4) right hand, index and middle
finger. The MVSFCSS 3300 is portable, light weight, hand held and
easy to use in primary and secondary modes of operation in all
operational environments.
[0211] Given the complex nature of integration into hospital
networks, in some implementations, the MVSFCSS 3300 does not
include site communication infrastructure, rather the collected
data (vital sign) is extracted from the MVSFCSS 3300 via a USB port
or by a USB mass storage stick that is inserted into the MVSFCSS
3300 or by connecting the MVSFCSS 3300 directly to a PC system as a
mass storage device itself.
[0212] The MVS smartphone 3103, when connected to a wireless
Bluetooth.RTM. communication component 1916 of the MVSFCSS 3300 via
a wireless Bluetooth.RTM. communication component 3114, is a slave
to the MVSFCSS 3300. The MVS Smartphone 3103 reports status,
measurement process, and measurement measurements to the user via
the MVSFCSS 3300.
[0213] When the MVS Smartphone 3103 is connected to the MVSFCSS
3300, the MVS Smartphone 3103 performs patient bar code scan or
identification entry as requested by MVSFCSS 3300, the MVS
Smartphone 3103 performs an operator bar code scan or
identification entry as requested by MVSFCSS 3300, the MVS
Smartphone 3103 performs human temperature measurement as requested
by MVSFCSS 3300, the MVS Smartphone 3103 displays information that
is related to the MVSFCSS 3300 direct action, the MVSFCSS 3300
starts when the MVS Smartphone 3103 is started, and the MVSFCSS
3300 is shutdown under the direction and control of the MVS
Smartphone 3103. In some implementations, the information displayed
by the MVS Smartphone 3103 includes battery status of the MVSFCSS
3300, device status of the MVSFCSS 3300, MVSFCSS 3300 display mode
and device revision numbers of the MVS Smartphone 3103 and the
MVSFCSS 3300. In some implementations, when a body surface
temperature of a human is also sensed by an infrared finger
temperature sensor 1908 in the MVS smartphone 3103, the body
surface temperature is collected and managed by the MVSFCSS
3300.
[0214] In some implementations, the multi-vital-sign finger cuff
smartphone system (MVSFCSS) 3300 includes the following sensors and
sensor signal capture and processing components that are required
to extract the required primary and secondary human vital signs
measurements: the MVS finger cuff 1904 that includes a PLM
subsystem and two mDLS sensors, the infrared finger temperature
sensor 1908, a proximity sensor 1910 and another non-disposable
sensor(s) for other human measurements sensor 1912 or ambient air
temperature sensor 1909.
[0215] The MVSFCSS 3300 performs concurrent two stage measurement
processes for all measurements. The measurement process performed
by the MVSFCSS 3300 is controlled and guided from the MVSFCSS 3300
via the GUI on the MVS Smartphone 3103. The measurements are
sequenced and configured to minimize time required to complete all
measurements. In some implementations, the MVSFCSS 3300 calculates
the secondary measurements of heart rate variability and blood
flow. The MVSFCSS 3300 commands and controls the MVS Smartphone
3103 via a wireless Bluetooth.RTM. protocol communication path 3012
and in some further implementations, the MVS Smartphone 3103
communicates with the MVSFCSS 3300, which could also be
concurrent.
[0216] In some implementations, the MVSFCSS 3300 includes the USB
On-the-Go port 3304 for interface with slave devices only, such as
the MVS Smartphone 3103, to perform the following functions:
recharge the internal rechargeable batteries 1920, export sensor
data sets to a windows based computer system, firmware update of
the MVSFCSS 3300 via an application to control and manage the
firmware update of the MVSFCSS 3300 and configuration update of the
MVSFCSS 3300. The MVSFCSS 3300 does update the MVS Smartphone 3103
firmware. The internal batteries of the MVSFCSS 3300 can be
recharged when the MVSFCSS 3300 is powered-off but while connected
to USB or DC input. In some implementations, the MVSFCSS 3300 can
recharge the MVS Smartphone 3103 from its internal power source
over a wireless charging connection. In some implementations, the
internal rechargeable batteries 1920 provide sufficient operational
life of the MVSFCSS 3300 on a single charge to perform at least 2
days of full measurements before recharging of the internal
rechargeable batteries 1920 of the MVSFCSS 3300 is required.
[0217] In some implementations, the MVSFCSS 3300 includes visual
indicators 1940 such as a fatal fault indicator that indicates the
MVSFCSS 3300 has failed and will not power up, a device fault
indicator (that indicates the MVSFCSS 3300 has a fault that would
affect the measurement function), a battery charging status
indicator, a battery charged status indicator, and/or a battery
fault status indicator.
[0218] The MVSFCSS 3300 also includes a cellular communication
module 1944 (this could be integrated into the processor) for
communications via cell communication frequencies and a Wi-Fi.RTM.
communication module 1942 (this could be integrated into the
processor) for communications via Wi-Fi.RTM. communication
frequencies. In some implementations, the MVSFCSS 3300 also
includes an audio sub-system 1946 that controls at one or more
speakers 1948 to enunciate information to an operator or patient
via tones, polymorphic and general music/speech capability.
[0219] MVSFCSS 3300 includes a microprocessor 3320 that controls
and communicates with the sensor management component 3302, the
CMOS camera 3308, the lens 3310, the cellular communication module
1944, the wireless communication module 1942, the audio sub-system
1946, speakers 1948, the USB port 3304, the batteries 3306 and the
visual indicators 1940. In some implementations, the sensor
management component 3302 is a component of the microprocessor
3320. The MVSFCSS 3300 is hand held and portable. The MVSFCSS 3300
includes non-slip/slide exterior surface material.
[0220] Vital signs are received from sensor management component
3302. The vital signs that are received are then displayed by a LCD
display 3116 and/or transmitted by the cellular communication
module 1944, the wireless communication module 1942 and/or the
wireless Bluetooth.RTM. communication component 3114, enunciated by
a speaker 1948 or stored by a flash memory. Examples of the vital
signs that are displayed on the display are FIG. 65-66.
[0221] FIG. 34 is a block diagram of a MVS smartphone system 3400,
according to an implementation. The MVS smartphone system 3400
includes two communicatively coupled devices; a MVS smartphone 3402
and a MVS finger cuff accessory (MVSFCA) 3404. MVS smartphone 3402
is one implementation of MVS smartphone 3004 in FIG. 30 and one
implementation of MVS smartphone 3103 in FIG. 31. MVSFCA 3404 is
one implementation of MVSFCA 3002 in FIG. 30 and one implementation
of MVSFCA 3102 in FIG. 31. The MVS smartphone system 3400, the
MVSFCA 3404 and the MVS smartphone 3402 are all examples of the MVS
apparatus 5504. The MVS smartphone 3402 captures, stores and
exports raw data from all supported sensors in the MVS smartphone
system 3400. More specifically, the MVS smartphone 3402 extracts
the vital signs through the MVSFCA 3404, displays the vital signs
and transfers the vital signs to either a remote third party, hub,
bridge etc., or a device manager, or directly to remote
EMR/HER/Hospital systems or other third party local or cloud based
systems. MVS smartphone system 3400 provides a flexible human vital
sign measurement methodology that supports different measurement
methods and techniques. The MVS smartphone system 3400 can be used
in a clinical setting for the collection of human vital signs.
[0222] The MVSFCA 3404 include a MVS finger cuff 3406 (such as MVS
finger cuff 1904 in FIG. 19) that is fixed into the MVSFCA 3404,
rather than the replaceable, detachable and removable MVS finger
cuff 3006 in FIG. 30. MVS finger cuff 3406 is electrically coupled
to the MVSFCA 3404 via a serial line 3407. The MVS finger cuff 3406
includes a PLM subsystem 2006 and at least one mDLS sensor 2011
and/or 2014. The MVS finger cuff 3406 is powered by and connected
to a finger sensor cable (FSC) 3408 that includes an air line (e.g.
3006 in FIG. 30), the air line being powered by a pneumatic engine
1906 in the MVSFCA 3404 that provides air pressure to inflate a
cuff bladder of the pressure finger cuff 2050 and the controlled
release of that air pressure.
[0223] In some implementations, a body surface temperature of a
human is also sensed by an infrared finger temperature sensor 1908
that is integrated into the MVS finger cuff 3406 in which the body
surface temperature is collected and managed by the MVS finger cuff
3406.
[0224] In some implementations, a single stage measurement process
is required to measure all vital signs in one operation by the MVS
smartphone 3402, the MVSFCA 3404 and the MVS finger cuff 3406
working cooperatively. However, in some implementations, a two
stage measurement process is performed in which the MVSFCA 3404
measures some vital signs through the MVS finger cuff 3406; and in
the second stage, the body surface temperature is measured through
an infrared finger temperature sensor 1908 in the MVS smartphone
3402. One implementation of the infrared finger temperature sensor
1908 is digital infrared sensor 1312 in FIG. 41.
[0225] The MVSFCA 3404 operates in two primary modes, the modes of
operation based on who takes the measurements, a patient or an
operator. The two modes are: 1) Operator Mode in which an operator
operates the MVSFCA 3404 through the MVS smartphone 3402 to take a
set of vital sign measurements of another human. The operator is
typically clinical staff or a home care giver. 2) Patient Mode in
which a patient uses the MVSFCA 3404 through the MVS smartphone
3402 to take a set of vital sign measurements of themselves. In
some implementations, the MVSFCA 3404 provides both the main
measurement modes for patient and operator. The primary measurement
areas on the human to be measured are 1) Left hand, index and
middle finger, 2) right hand, index and middle finger, and 3) human
forehead temperature (requires the MVS smartphone 3402 to perform
temperature measurement). The MVSFCA 3404 is portable, light
weight, hand held and easy to use in primary and secondary modes of
operation in all operational environments.
[0226] Given the complex nature of integration into hospital
networks, in some implementations, in some implementations the
MVSFCA 3404 does not include site communication infrastructure,
rather the collected data (vital sign) is extracted from the MVSFCA
3404 via a USB port 3122 or by a USB mass storage stick that is
inserted into the MVSFCA 3404 or by connecting the MVSFCA 3404
directly to a PC system as a mass storage device itself.
[0227] The MVSFCA 3404, when connected to a wireless Bluetooth.RTM.
communication component 3114 of the MVS smartphone 3402 via a
wireless Bluetooth.RTM. communication component 1916, can be a
slave to the MVS smartphone 3402. The MVSFCA 3404 reports status,
measurement process, and measurement measurements to the user via
the MVS smartphone 3402. The MVS smartphone 3402 provides a user
input method to the MVSFCA 3404 via a graphical user interface on a
LCD display 3116 which displays data representative of the
measurement process and status. In one implementation, the wireless
Bluetooth.RTM. communication component 3114 of the MVS smartphone
3402 includes communication capability with cellular communication
paths (3G, 4G and/or 5G) and/or Wi-H.RTM. communication paths, the
MVS smartphone 3402 is not a slave to the MVSFCA 3404 and the
MVSFCA 3404 captures vital sign data and transmits the vital sign
data via the wireless Bluetooth.RTM. communication component 3114
in the MVS smartphone 3402 and the MVS smartphone 3402 transmits
the vital sign data to the middle layer 5506 in FIG. 55 or the
MVSFCA 3404 transmits the vital sign data via the wireless
Bluetooth.RTM. communication component 1916 of the MVSFCA 3404 to
the bridge 5520, a Wi-Fi.RTM. access point, a cellular
communications tower or a bridge 5520 in FIG. 55. In other
implementations, Zigbee.RTM. or Z-Wave.RTM. can be used instead of
Bluetooth.RTM..
[0228] In some implementations, the MVS smartphone 3402 provides
communications with other devices via a communication component
3117 of the MVS smartphone 3402. The communication component 3117
has communication capability with cellular communication paths (3G,
4G and/or 5G) and/or Wi-Fi.RTM. communication paths. For example,
the MVSFCA 3404 captures vital sign data and transmits the vital
sign data via the wireless Bluetooth.RTM. communication component
1916 in the MVSFCA 3404 to the wireless Bluetooth.RTM.
communication component 3114 in the MVS smartphone 3402, and the
MVS smartphone 3402 transmits the vital sign data via the
communication component 3117 of the MVS smartphone 3402 to the
middle layer 5506 in FIG. 55 or the MVS smartphone 3402 transmits
the vital sign data via the communication component 3117 of the MVS
smartphone 3402 to the bridge 5520, a Wi-Fi.RTM. access point, a
cellular communications tower or a bridge 5520 in FIG. 55.
[0229] In some implementations, when the MVS smartphone 3402 is
connected to the MVSFCA 3404, the MVS smartphone 3402 performs
human bar code scan by a bar code scanner 3118 or identification
entry as requested by MVSFCA 3404, the MVS smartphone 3402 performs
an operator bar code scan or identification entry as requested by
MVSFCA 3404, the MVS smartphone 3402 displays information that is
related to the MVSFCA 3404, the MVS smartphone 3402 starts when the
MVSFCA 3404 is started, and the MVS smartphone 3402 is shutdown
under the direction and control of the MVSFCA 3404, and the MVS
smartphone 3402 has a self-test mode that determines the
operational state of the MVSFCA 3404 and sub systems, to ensure
that the MVSFCA 3404 is functional for the measurement. In other
implementations,
[0230] In some implementations, when the MVS smartphone 3402 is
connected to the MVSFCA 3404, the MVS smartphone 3402 performs
human bar code scan by a bar code scanner 3118 or identification
entry as requested by the MVSFCA 3404, the MVS smartphone 3402
performs an operator bar code scan or identification entry as
requested by the MVSFCA 3404, and the MVS smartphone 3402 displays
information that is related to the MVSFCA 3404. In some
implementations, the information displayed by the MVS smartphone
3402 includes date/time, human identification number, human name,
vitals measurement such as blood pressure (diastolic and systolic),
SpO2, heart rate, temperature, respiratory rate, MVSFCA 3404 free
memory slots, battery status of the MVS smartphone 3402, battery
status of the MVSFCA 3404, device status of the MVSFCA 3404, errors
of the MVS smartphone 3402, device measurement sequence,
measurement quality assessment measurement, mode of operation,
subject and operator identification, temperature, measurement,
display mode and device revision numbers of the MVS smartphone 3402
and the MVSFCA 3404. In some implementations, when a body surface
temperature of a human is also sensed by an infrared sensor in the
MVS smartphone 3402, the body surface temperature is collected and
managed by the MVSFCA 3404. In other implementations, when a body
surface temperature of a human is sensed by an infrared sensor in
the MVS smartphone 3402, the body surface temperature is not
collected and managed by the MVSFCA 3404.
[0231] In some implementations, the MVS finger cuff accessory
(MVSFCA) 3404 includes the following sensors and sensor signal
capture and processing components that are required to extract the
required primary and secondary human vital signs measurements: the
pressure finger cuff 2050, the PLM subsystem 2006 and two mDLS
sensors 2011 and 2014, the infrared finger temperature sensor 1908
and an ambient air temperature sensor 1909, and in some further
implementations, non-disposable sensors for other human vital sign
measurements. In some implementations, data sample rates for the
PLM subsystem 2006 is 2.times.200 Hz.times.24 bit=9600 bits/sec,
for each of the mDLS sensors 2011 and 2014 is 31 kHz.times.24
bit=1,572,864 b.pi./sec and for the ambient air temperature sensor
is less than 1000 bps. Two mDLS sensors 2011 and 2014 are included
in the MVS finger cuff 3406 to ensure that one or both sensors 2011
and 2014 delivers a good quality signal, thus increasing the
probability of obtaining a good signal from at least one of the
mDLS sensors 2011 and 2014.
[0232] The MVS smartphone 3402 performs concurrent two stage
measurement processes for all measurements. The measurement process
performed by the MVSFCA 3404 is controlled and guided from the MVS
smartphone 3402 via the GUI on the MVSFCA 3404. The measurements
are sequenced and configured to minimize time required to complete
all measurements. In some implementations, the MVS smartphone 3402
calculates the secondary measurements of heart rate variability and
blood flow from signals from the PLM subsystem 2006. The MVS
smartphone 3402 commands and controls the MVSFCA 3404 via a
wireless Bluetooth.RTM. protocol communication line and in some
further implementations, the MVSFCA 3404 communicates to other
devices through Bluetooth.RTM. protocol communication line (not
shown), in addition to the communications with the MVS smartphone
3402, which could also be concurrent. In some further
implementations, the MVS smartphone 3402 communicates to other
devices through Bluetooth.RTM. protocol communication line (not
shown), in addition to the communications with the MVSFCA 3404
device, which could also be concurrent.
[0233] MVSFCA 3404 includes USB port 3122 to perform the following
functions: recharge the internal rechargeable batteries 1920 of the
MVSFCA 3404, export sensor data sets to a windows based computer
system 3412, firmware update of the MVSFCA 3404 via an application
to control and manage the firmware update of the MVSFCA 3404 and
configuration update of the MVSFCA 3404. The MVSFCA 3404 does not
update the MVS smartphone 3402 firmware. The internal rechargeable
batteries 1920 can be recharged via a USB port 3122, which provides
charge, and the MVSFCA 3404 can also include an external direct DC
input providing a fast recharge. The internal batteries 1920 of the
MVSFCA 3404 can be recharged when the MVSFCA 3404 is powered-off
but while connected to USB or DC input. In some implementations,
the MVSFCA 3404 can recharge the MVS smartphone 3402 from its
internal power source over a wireless charging connection. In some
implementations, the internal rechargeable batteries 1920 provide
sufficient operational life of the MVSFCA 3404 on a single charge
to perform at least 2 days of full measurements before recharging
of the internal rechargeable batteries 1920 of the MVSFCA 3404 is
required.
[0234] In some implementations, the MVSFCA 3404 includes an
internal non-volatile, non-user removable, data storage device 1930
for up to 20 human raw measurement data sets. The data storage
device 1930 can be removed by a technician when the data storage
device 1930 is determined to be faulty. A human measurement set
contains all measurement data and measurements acquired by the
MVSFCA 3404, including the temperature measurement from the MVS
smartphone 3402. The internal memory is protected against data
corruption in the event of an abrupt power loss event. The MVSFCA
3404 and the MVS finger cuff 3406 have a human-form fit function.
The MVSFCA 3404 also includes anti-microbial exterior material to
and an easy clean surface for all sensor and device surfaces. The
MVSFCA 3404 stores in the data storage device 1930 an "atomic"
human record structure that contains the entire data set recording
for a single human measurement containing all human raw sensor
signals and readings, extracted human vitals, and system status
information. The MVSFCA 3404 includes self-test components that
determine the operational state of the MVSFCA 3404 and sub systems,
to ensure that the MVSFCA 3404 is functional for measurement. The
MVSFCA 3404 includes a clock function for date and time. In some
implementations. The date and time of the MVSFCA 3404 is be updated
from the MVS smartphone 3402. In some implementations, the MVSFCA
3404 includes user input controls, such as a power on/off switch
(start/stop), an emergency stop control to bring the pressure
finger cuff 2050 to a deflated condition. In some implementations,
all other input is supported via the MVS smartphone 3402 via on
screen information of the MVS smartphone 3402. In some
implementations, the MVSFCA 3404 includes visual indicators 1940
such as a fatal fault indicator that indicates device has failed
and will not power up, a device fault indicator (that indicates the
MVSFCA 3404 has a fault that would affect the measurement
function), battery charging status indicator, battery charged
status indicator or a battery fault status indicator.
[0235] The components (e.g. 1906, 1916, 1920, 3122, 1930 and 1940)
in the MVSFCA 3404 are controlled by a control process and signal
processing component 3127. The control process and signal
processing component 3127 be can implemented in a microprocessor or
by a FPGA.
[0236] The external USB charger 3410 provides electrical power to
recharge the MVSFCA 3404. The external USB charger 3410 can provide
electrical power to recharge the batteries of the MVSFCA 3404
either via a physical wired connection or via a wireless charger.
In some implementations, the external USB charger 3410 does not
provide electrical power to the MVSFCA 3404 because the MVSFCA 3404
includes internal rechargeable batteries 1920 that can be recharged
via either USB port 3122 or a DC input. The MVSFCA 3404 is hand
held and portable. The MVSFCA 3404 includes non-slip/slide exterior
surface material.
[0237] Vital signs are received through the wireless Bluetooth.RTM.
communication component 3114 from a MVSFCA such as the MVSFCAs in
FIGS. 12-20 and 30-34 or the MVS finger clip in FIG. 21-27. The
vital signs that are received are then displayed by display 2928
an/or transmitted by the communication component 3117, enunciated
by a speaker or stored by flash memory. Examples of the vital signs
that are displayed on the display 2928 are FIG. 65-66.
[0238] MVS Smartphones 2800 in FIG. 28, MVS smartphone 2900 in FIG.
29, MVS smartphone 3200 in FIG. 32, MVS smartphone 3004 in FIG. 30,
MVS smartphone 3103 in FIG. 31, and MVS smartphone 3402 in FIG. 34
are production smartphones that have been modified by either
downloading software to volatile memory or including non-volatile
memory to receive, determine/calculate, display and/or transmit the
multi-vital signs. In some implementations, of the apparatus,
systems and methods described herein, a heart rate is estimated
from data from a PLM subsystem, a respiration rate and a heart rate
variability and/or a blood pressure diastolic is estimated from
data from a micro dynamic light scattering sensor and the PLM
subsystem. In some implementations, SpO2 blood oxygenation is
estimated from data from the PLM subsystem, respiration rate is
estimated from data from the micro dynamic light scattering sensor
and blood pressure is estimated from data from the micro dynamic
light scattering sensor in conjunction with data from the finger
cuff.
7. Apparatus of Multi-Vital-Sign Devices
[0239] FIG. 35 is a block diagram of a MVS device 3500 that
includes a digital infrared sensor, a biological vital sign
generator and a temporal motion amplifier, according to an
implementation. MVS device 3500 is an apparatus to measure body
core temperature and other biological vital signs. The MVS device
3500 is one example of the MVS apparatus 5504.
[0240] The MVS device 3500 includes a microprocessor 3502. The MVS
device 3500 includes a battery 3504, in some implementations a
single button 3506, and a digital infrared sensor 3508 that is
operably coupled to the microprocessor 3502. The digital infrared
sensor 3508 includes digital ports 3510 that provide only digital
readout signal 3511. One example of the digital infrared sensor
3508 is digital infrared sensor 1312 in FIG. 41. In some
implementations the MVS device 3500 includes a display device 3514
that is operably coupled to the microprocessor 3502. In some
implementations, the display device 3514 is a LCD color display
device or a LED color display device, which are easy to read in a
dark room, and some pixels in the display device 3514 are activated
(remain lit) for about 5 seconds after the single button 3506 is
released. After the display has shut off, another body core
temperature reading can be taken by the apparatus. The color change
of the display device 3514 is to alert the operator of the
apparatus of a potential change of body core temperature of the
human or animal subject. The body core temperature reported on the
display device 3514 can be used for treatment decisions.
[0241] The microprocessor 3502 is configured to receive from the
digital ports 3510 that provide only digital readout signal 3511.
In some implementations, the digital readout signal 3511 is
representative of an infrared signal 3516 of a forehead surface
temperature that is detected by the digital infrared sensor 3508.
In other implementations, the digital readout signal 3511 is
representative of an infrared signal 3516 of a surface temperature
of a human other than the forehead surface that is detected by the
digital infrared sensor 3508. A body core temperature estimator
3518 in the microprocessor 3502 is configured to estimate the body
core temperature 3520 from the digital readout signal 3511 that is
representative of the infrared signal 3516 of the forehead (or
other surface), a representation of an ambient air temperature
reading from an ambient air sensor 1909, a representation of a
calibration difference from a memory location that stores a
calibration difference 3524 and a memory location that stores a
representation of a bias 3526 in consideration of a temperature
sensing mode. In some implementations, the MVS device 3500 does not
include an analog-to-digital converter 3512 operably coupled
between the digital infrared sensor 3508 and the microprocessor
3502. Furthermore, the digital infrared sensor 3508 also does not
include analog readout ports 3513. The dashed lines of the A/D
converter 3512 and the analog readout ports 3513 indicates absence
of the A/D converter 3512 and the analog readout ports 3513 in the
MVS device 3500
[0242] A temperature estimation table 3527 is a lookup table that
correlates a sensed forehead temperature to an estimated body core
temperature 3520. The sensed forehead temperature is derived from
the digital readout signal 3511.
[0243] The temperature estimation table 3527 is stored in a memory.
In FIG. 38-40, the temperature estimation table 3527 is shown as a
component of the microprocessor 3502. The memory that stores the
temperature estimation table 3527 can be separate from the
microprocessor 3502 or the memory can be a part of the
microprocessor 3502, such as cache on the microprocessor 3502.
Examples of the memory include Random Access Memory (RAM) 2806 and
flash memory 2808 in FIG. 28. In implementations of the MVS
smartphone systems in FIG. 30-34, the apparatus that estimates a
body core temperature in FIG. 38-40, the apparatus of motion
amplification in FIG. 46-54, the MVS smartphone 2800 in which speed
of the MVS smartphone systems in FIGS. 35-39 and the apparatus that
estimate a body core temperature of an external source point in
FIG. 38-40 is very important, storing the temperature estimation
table 3527 in memory that is a part of the microprocessor 3502,
such as cache on the microprocessor 3502, is very important.
[0244] The correlation between the sensed forehead temperature to
an estimated body core temperature varies based on age, sex, and a
febrile (pyretic) or hypothermic condition of the patient and
intraday time of the reading. Accordingly, in some implementations,
the MVS apparatus 5504 includes temperature estimation tables 3527
that are specific to the combinations and permutations of the
various situations of the age, sex, and a febrile (pyretic) or
hypothermic condition of the patient and the intraday time of the
reading. For example, in one implementation, the MVS apparatus 5504
include a temperature estimation table 3527 for male humans of 3-10
years old, that are neither febrile nor hypothermic, for
temperature readings taken between 10 am-2 pm. In another example,
in another implementation, the MVS apparatus 5504 include a
temperature estimation table 3527 for female humans of greater than
51 years of age, that are febrile and for temperature readings
taken between 2 am-8 am.
[0245] Some implementations of the MVS device 3500 include a
solid-state image transducer 2852 that is operably coupled to the
microprocessor 3502 and is configured to provide two or more images
2854 to a temporal-motion-amplifier 3532 and a biological vital
sign generator 3534 in the microprocessor 3502 to estimate one or
more biological vital signs 3536 that are displayed on the display
device 3514.
[0246] The MVS device 3500 includes any one of a pressure sensor
3538, a pressure cuff 3540, a micro dynamic light scattering (mDLS)
sensor 3542 and/or a physiological light monitoring (PLM) subsystem
3544 that provide signals to the biological vital sign generator
3534. The mDLS sensor uses a laser beam (singular wavelength) of
light and a light detector on the opposite side of the finger to
detect the extent of the laser beam that is scattered in the flesh
of the finger, which indicates the amount of oxygen in blood in the
fingertip. The PLM subsystem uses projected light and a light
detector on the opposite side of the finger to detect the extent of
the laser beam that is absorbed in the flesh of the finger, which
indicates the amount of oxygen in blood in the fingertip, which is
also known as pulse oximetry. The pressure sensor 3538 is directly
linked to the pressure cuff 3540. In some implementations, the MVS
device 3500 includes two mDLS sensors to ensure that at least one
of the mDLS sensors provides a good quality signal. In some
implementations, the biological vital sign generator 3534 generates
blood pressure measurement (systolic and diastolic) from signals
from the pressure sensor 3538, the finger pressure cuff 3540 and
the mDLS sensor 3542. In some implementations, the biological vital
sign generator 3534 generates blood glucose levels from signals
from the PLM subsystem 3544. In some implementations, the
biological vital sign generator 3534 generates SpO2 measurement and
heart rate measurement from signals from the PLM subsystem 3544. In
some implementations, the biological vital sign generator 3534
generates respiration (breathing rate) measurement from signals
from the mDLS sensor 3542. In some implementations, the biological
vital sign generator 3534 generates blood flow measurement from
signals from the mDLS sensor 3542. In some implementations, the
biological vital sign generator 3534 generates heartrate
variability from signals from the PLM subsystem 3544. In some
implementations, the body core temperature estimator 3518 is
implemented in the biological vital sign generator 3534.
[0247] The MVS device 3500 also includes a wireless communication
subsystem 2804 or other external communication subsystem, such as
an Ethernet port, that provides communication to the EMR data
capture systems 5500 and 5700 or other devices. In some
implementations, the wireless communication subsystem 2804 is
communication subsystem 2804 in FIG. 44. The wireless communication
subsystem 2804 is operable to receive and transmit the estimated
body core temperature 3520 and/or the biological vital sign(s)
3536.
[0248] In some implementations, the digital infrared sensor 3508 is
a low noise amplifier, 17-bit ADC and powerful DSP unit through
which high accuracy and resolution of the estimated body core
temperature 3520 by the MVS smartphone systems in FIG. 30-34, the
apparatus that estimates a body core temperature in FIGS. 35-40 and
41, the apparatus of motion amplification in FIGS. 46-54 and the
MVS smartphone 2800.
[0249] In some implementations, the digital infrared sensor 3508,
10-bit pulse width modulation (PWM) is configured to continuously
transmit the measured temperature in range of -20 . . . 120.degree.
C., with an output resolution of 0.14.degree. C. The factory
default power on reset (POR) setting is SMBus.
[0250] In some implementations, the digital infrared sensor 3508 is
packaged in an industry standard TO-39 package.
[0251] In some implementations, the generated object and ambient
air temperatures are available in RAM of the digital infrared
sensor 3508 with resolution of 0.01.degree. C. The temperatures are
accessible by 2 wire serial SMBus compatible protocol (0.02.degree.
C. resolution) or via 10-bit PWM (Pulse Width Modulated) output of
the digital infrared sensor 3508.
[0252] In some implementations, the digital infrared sensor 3508 is
factory calibrated in wide temperature ranges: -40 . . . 85.degree.
C. for the ambient air temperature and -70 . . . 380.degree. C. for
the object temperature.
[0253] In some implementations of the digital infrared sensor 3508,
the measured value is the average temperature of all objects in the
Field Of View (FOV) of the sensor. In some implementations, the
digital infrared sensor 3508 has a standard accuracy of
.+-.0.5.degree. C. around room temperatures, and in some
implementations, the digital infrared sensor 3508 has an accuracy
of .+-.0.2.degree. C. in a limited temperature range around the
human body core temperature.
[0254] These accuracies are only guaranteed and achievable when the
sensor is in thermal equilibrium and under isothermal conditions
(there are no temperature differences across the sensor package).
The accuracy of the detector can be influenced by temperature
differences in the package induced by causes like (among others):
Hot electronics behind the sensor, heaters/coolers behind or beside
the sensor or by a hot/cold object very close to the sensor that
not only heats the sensing element in the detector but also the
detector package. In some implementations of the digital infrared
sensor 3508, the thermal gradients are measured internally and the
measured temperature is compensated in consideration of the thermal
gradients, but the effect is not totally eliminated. It is
therefore important to avoid the causes of thermal gradients as
much as possible or to shield the sensor from the thermal
gradients.
[0255] In some implementations, the digital infrared sensor 3508 is
configured for an object emissivity of 1, but in some
implementations, the digital infrared sensor 3508 is configured for
any emissivity in the range 0.1 . . . 1.0 without the need of
recalibration with a black body.
[0256] In some implementations of the digital infrared sensor 3508,
the PWM can be easily customized for virtually any range desired by
the customer by changing the content of 2 EEPROM cells. Changing
the content of 2 EEPROM cells has no effect on the factory
calibration of the device. The PWM pin can also be configured to
act as a thermal relay (input is To), thus allowing for an easy and
cost effective implementation in thermostats or temperature
(freezing/boiling) alert applications. The temperature threshold is
programmable by the microprocessor 3502 of the MVS smartphone
system. In a MVS smartphone system having a SMBus system the
programming can act as a processor interrupt that can trigger
reading all slaves on the bus and to determine the precise
condition.
[0257] In some implementations, the digital infrared sensor 3508
has an optical filter (long-wave pass) that cuts off the visible
and near infra-red radiant flux is integrated in the package to
provide ambient and sunlight immunity. The wavelength pass band of
the optical filter is from 5.5 to 14 .mu.m.
[0258] In some implementations, the digital infrared sensor 3508 is
controlled by an internal state machine, which controls the
measurements and generations of the object and ambient air
temperatures and does the post-processing of the temperatures to
output the body core temperatures through the PWM output or the
SMBus compatible interface.
[0259] Some implementations of the MVS smartphone system includes 2
IR sensors, the output of the IR sensors being amplified by a low
noise low offset chopper amplifier with programmable gain,
converted by a Sigma Delta modulator to a single bit stream and fed
to a DSP for further processing. The signal is treated by
programmable (by means of EEPROM contend) FIR and IIR low pass
filters for further reduction of the bandwidth of the input signal
to achieve the desired noise performance and refresh rate. The
output of the IIR filter is the measurement result and is available
in the internal RAM. 3 different cells are available: One for the
on-board temperature sensor and 2 for the IR sensors. Based on
results of the above measurements, the corresponding ambient air
temperature Ta and object temperatures To are generated. Both
generated body core temperatures have a resolution of 0.01.degree.
C. The data for Ta and To is read in two ways: Reading RAM cells
dedicated for this purpose via the 2-wire interface (0.02.degree.
C. resolution, fixed ranges), or through the PWM digital output (10
bit resolution, configurable range). In the last step of the
measurement cycle, the measured Ta and To are rescaled to the
desired output resolution of the PWM) and the regenerated data is
loaded in the registers of the PWM state machine, which creates a
constant frequency with a duty cycle representing the measured
data.
[0260] In some implementations, the digital infrared sensor 3508
includes a SCL pin for Serial clock input for 2 wire communications
protocol, which supports digital input only, used as the clock for
SMBus compatible communication. The SCL pin has the auxiliary
function for building an external voltage regulator. When the
external voltage regulator is used, the 2-wire protocol for a power
supply regulator is overdriven.
[0261] In some implementations, the digital infrared sensor 3508
includes a slave deviceA/PWM pin for digital input/output. In
normal mode the measured object temperature is accessed at this pin
Pulse Width Modulated. In SMBus compatible mode the pin is
automatically configured as open drain NMOS. Digital input/output,
used for both the PWM output of the measured object temperature(s)
or the digital input/output for the SMBus. In PWM mode the pin can
be programmed in EEPROM to operate as Push/Pull or open drain NMOS
(open drain NMOS is factory default). In SMBus mode slave deviceA
is forced to open drain NMOS I/O, push-pull selection bit defines
PWM/Thermal relay operation. The PWM/slave deviceA pin the digital
infrared sensor 3508 operates as PWM output, depending on the
EEPROM settings. When WPWM is enabled, after POR the PWM/slave
deviceA pin is directly configured as PWM output. When the digital
infrared sensor 3508 is in PWM mode, SMBus communication is
restored by a special command In some implementations, the digital
infrared sensor 3508 is read via PWM or SMBus compatible interface.
Selection of PWM output is done in EEPROM configuration (factory
default is SMBus). PWM output has two programmable formats, single
and dual data transmission, providing single wire reading of two
temperatures (dual zone object or object and ambient). The PWM
period is derived from the on-chip oscillator and is
programmable.
[0262] The microprocessor 3502 has read access to the RAM and
EEPROM and write access to 9 EEPROM cells (at addresses 0x00, 0x01,
0x02, 0x03, 0x04, 0x05, 0x0E, 0x0F, 0x09). When the access to the
digital infrared sensor 3508 is a read operation, the digital
infrared sensor 3508 responds with 16 data bits and 8 bit PEC only
if its own slave address, programmed in internal EEPROM, is equal
to the SA, sent by the master. A slave feature allows connecting up
to 127 devices (SA=0x00 . . . 0x07F) with only 2 wires. In order to
provide access to any device or to assign an address to a slave
device before slave device is connected to the bus system, the
communication starts with zero slave address followed by low R/W
bit. When the zero slave address followed by low R/W bit sent from
the microprocessor 3502, the digital infrared sensor 3508 responds
and ignores the internal chip code information. In some
implementations, two digital infrared sensors 3508 are not
configured with the same slave address on the same bus.
[0263] In regards to bus protocol, after every received 8 bits, the
slave device should issue ACK or NACK. When a microprocessor 3502
initiates communication, the microprocessor 3502 first sends the
address of the slave and only the slave device which recognizes the
address will ACK, the rest will remain silent. In case the slave
device NACKs one of the bytes, the microprocessor 3502 stops the
communication and repeat the message. A NACK could be received
after the packet error code (PEC). A NACK after the PEC means that
there is an error in the received message and the microprocessor
3502 attempts resending the message. PEC generation includes all
bits except the START, REPEATED START, STOP, ACK, and NACK bits.
The PEC is a CRC-8 with polynomial X8+X2+X1+1. The Most Significant
Bit of every byte is transferred first.
[0264] In single PWM output mode the settings for PWM1 data only
are used. The temperature reading can be generated from the signal
timing as:
T OUT = ( 2 t 2 T .times. ( T O_MAX - T O_MIN ) ) + T O_MIN
##EQU00003##
[0265] where Tmin and Tmax are the corresponding rescale
coefficients in EEPROM for the selected temperature output (Ta,
object temperature range is valid for both Tobj1 and Tobj2 as
specified in the previous table) and T is the PWM period. Tout is
TO1, TO2 or Ta according to Config Register [5:4] settings.
[0266] The different time intervals t1 . . . t4 have following
meaning:
[0267] t1: Start buffer. During t1 the signal is always high.
t1=0.125s.times.T (where T is the PWM period)
[0268] t2: Valid Data Output Band, 0 . . . 1/2T. PWM output data
resolution is 10 bit.
[0269] t3: Error band--information for fatal error in EEPROM
(double error detected, not correctable).
[0270] t3=0.25s.times.T. Therefore a PWM pulse train with a duty
cycle of 0.875 indicates a fatal error in EEPROM (for single PWM
format). FE means Fatal Error.
[0271] In regards to a format for extended PWM, the temperature can
be generated using the following equation:
T OUT 1 = ( 4 t 2 T .times. ( T MAX 1 - T MIN 1 ) ) + T MIN 1
##EQU00004## [0272] For Data 2 field the equation is:
[0272] T OUT 2 = ( 4 t 5 T .times. ( T MAX 2 - T MIN 2 ) ) + T MIN
2 ##EQU00005##
[0273] In some implementations of FIG. 38-40, the microprocessor
3502, the image transducer 2852, the pressure sensor 3538, the
pressure cuff 3540, the micro dynamic light scattering (mDLS)
sensor 3542 and/or the physiological light monitoring (PLM)
subsystem 3544 are located in the MVS finger cuff smartphone system
and the display devices 3514 and 3614 are located in the MVS
smartphone.
[0274] In some implementations of FIG. 38-40, the image transducer
2852, the pressure sensor 3538, the pressure cuff 3540, the micro
dynamic light scattering (mDLS) sensor 3542 and/or the
physiological light monitoring (PLM) subsystem 3544 are located in
the MVS finger cuff smartphone system and the microprocessor 3502
and the display devices 3514 and 3614 are located in the MVS
smartphone.
[0275] FIG. 36 is a block diagram of a MVS device 3600 that
includes a non-touch electromagnetic sensor with no temporal motion
amplifier, according to an implementation. The MVS device 3600 is
one example of the MVS smartphone system 5504 and one example of
the MVS finger cuff accessory (MVSFCA) 3102. The MVS device 3600
includes a battery 3504, in some implementations a single button
3506, in some implementations a display device 3514, a non-touch
electromagnetic sensor 3602 and an ambient air sensor 1909 that are
operably coupled to the microprocessor 3502. The microprocessor
3502 is configured to receive a representation of an infrared
signal 3516 of the forehead or other external source point from the
non-touch electromagnetic sensor 3602. The microprocessor 3502
includes a body core temperature estimator 3518 that is configured
to estimate the body core temperature 3612 of the subject from the
representation of the electromagnetic energy of the external source
point.
[0276] The MVS device 3600 includes a pressure sensor 3538, a
pressure cuff 3540, a mDLS sensor 3542 and a PLM subsystem 3544
that provide signals to the biological vital sign generator 3534.
The pressure sensor 3538 is directly linked to the pressure cuff
3540. In some implementations, the MVS device 3600 includes two
mDLS sensors to ensure that at least one of the mDLS sensors
provides a good quality signal. In some implementations, the
biological vital sign generator 3534 generates blood pressure
measurement (systolic and diastolic) from signals from the pressure
sensor 3538, the finger pressure cuff 3540 and the mDLS sensor
3542. In some implementations, the biological vital sign generator
3534 generates SpO2 measurement and heart rate measurement from
signals from the PLM subsystem 3544. In some implementations, the
biological vital sign generator 3534 generates respiration
(breathing rate) measurement from signals from the mDLS sensor
3542. In some implementations, the biological vital sign generator
3534 generates blood flow measurement from signals from the mDLS
sensor 3542. In some implementations, the biological vital sign
generator 3534 generates heartrate variability from signals from
the PLM subsystem 3544.
[0277] The body core temperature correlation table for all ranges
of ambient air temperatures provides best results because a linear
or a quadratic relationship provide inaccurate estimates of body
core temperature, yet a quantic relationship, a quintic
relationship, sextic relationship, a septic relationship or an
octic relationship provide estimates along a highly irregular curve
that is far too wavy or twisting with relatively sharp
deviations.
[0278] The non-touch electromagnetic sensor 3602 detects
temperature in response to remote sensing of a surface a human or
animal. In some implementations, the MVS smartphone system having
an infrared sensor is an infrared temperature sensor. All humans or
animals radiate infrared energy. The intensity of this infrared
energy depends on the temperature of the human or animal, thus the
amount of infrared energy emitted by a human or animal can be
interpreted as a proxy or indication of the body core temperature
of the human or animal The non-touch electromagnetic sensor 3602
measures the temperature of a human or animal based on the
electromagnetic energy radiated by the human or animal The
measurement of electromagnetic energy is taken by the non-touch
electromagnetic sensor 3602 which constantly analyzes and registers
the ambient air temperature. When the operator of apparatus in FIG.
36 holds the non-touch electromagnetic sensor 3602 about 5-8 cm
(2-3 inches) from the forehead and activates the radiation sensor,
the measurement is instantaneously measured. To measure a
temperature using the non-touch electromagnetic sensor 3602,
pushing the button 3506 causes a reading of temperature measurement
from the non-touch electromagnetic sensor 3602 and in some
implementations the measured body core temperature is thereafter
displayed on the display device 3514. Various implementations of
the non-touch electromagnetic sensor 3602 can be a digital infrared
sensor, such as digital infrared sensor 3508 or an analog infrared
sensor.
[0279] The body core temperature estimator 3518 correlates the
temperatures sensed by the non-touch electromagnetic sensor 3602 to
another temperature, such as a body core temperature of the
subject, an axillary temperature of the subject, a rectal
temperature of the subject and/or an oral temperature of the
subject. The body core temperature estimator 3518 can be
implemented as a component on a microprocessor, such as main
processor 2802 in FIG. 28 or on a memory such as flash memory 2808
in FIG. 28.
[0280] The MVS device 3600 also detects the body core temperature
of a human or animal regardless of the room temperature because the
measured temperature of the non-touch electromagnetic sensor 3602
is adjusted in reference to the ambient air temperature in the air
in the vicinity of the apparatus. The human or animal must not have
undertaken vigorous physical activity prior to temperature
measurement in order to avoid a misleading high temperature. Also,
the room temperature should be moderate, 50.degree. F. to
80.degree. F.
[0281] The MVS device 3600 provides a non-invasive and
non-irritating means of measuring human or animal body core
temperature to help ensure good health. When evaluating results,
the potential for daily variations in body core temperature can be
considered. In children less than 6 months of age daily variation
is small In children 6 months to 4 years old the variation is about
1 degree. By age 6 variations gradually increase to 4 degrees per
day. In adults there is less body core temperature variation.
[0282] The MVS device 3600 also includes a wireless communication
subsystem 2804 or other external communication subsystem, such as
an Ethernet port, that provides communication to the EMR data
capture systems 5500 and 5700. In some implementations, the
wireless communication subsystem 2804 is communication subsystem
2804 in FIG. 44.
[0283] FIG. 37 is a block diagram of a MVS device 3700 that
includes a non-touch electromagnetic sensor and that detects
biological vital-signs from images captured by a solid-state image
transducer, according to an implementation. The MVS device 3700 is
one example of the MVS smartphone system 5504 and one example of
the MVS finger cuff smartphone system (MVSFCSS) 502 in FIG. 5. The
MVS device 3700 includes a battery 3504, in some implementations a
single button 3506, in some implementations a display device 3514,
a non-touch electromagnetic sensor 3602 and an ambient air sensor
1909 that are operably coupled to the microprocessor 3502. The
microprocessor 3502 is configured to receive a representation of an
infrared signal 3516 of the forehead or other external source point
from the non-touch electromagnetic sensor 3602. The microprocessor
3502 includes a body core temperature estimator 3518 that is
configured to estimate the body core temperature 3612 of the
subject from the representation of the electromagnetic energy of
the external source point. The MVS device 3700 includes a
solid-state image transducer 2852 that is operably coupled to the
microprocessor 3502 and is configured to provide two or more images
2854 to the microprocessor 3502.
[0284] The MVS device 3700 include a pressure sensor 3538, a
pressure cuff 3540, a mDLS sensor 3542 and a PLM subsystem 3544
that provide signals to the biological vital sign generator 3534.
The pressure sensor 3538 is directly linked to the pressure cuff
3540. In some implementations, the MVS device 3700 includes two
mDLS sensors to ensure that at least one of the mDLS sensors
provides a good quality signal. In some implementations, the
biological vital sign generator 3534 generates blood pressure
measurement (systolic and diastolic) from signals from the pressure
sensor 3538, the finger pressure cuff 3540 and the mDLS sensor
3542. In some implementations, the biological vital sign generator
3534 generates SpO2 measurement and heart rate measurement from
signals from the PLM subsystem 3544. In some implementations, the
biological vital sign generator 3534 generates respiration
(breathing rate) measurement from signals from the mDLS sensor
3542. In some implementations, the biological vital sign generator
3534 generates blood flow measurement from signals from the mDLS
sensor 3542. In some implementations, the biological vital sign
generator 3534 generates heartrate variability from signals from
the PLM subsystem 3544.
8. Apparatus of Multi-Vital-Sign Components
[0285] FIG. 38 is a block diagram of an apparatus 3800 to estimate
a body core temperature from a forehead temperature sensed by an
infrared sensor, according to an implementation. Apparatus 3800
includes a power-initializer 3802 for the infrared sensor 3804 and
a time delay 3806 that delays subsequent processing for a period of
time specified by the time delay 3806 after power initialization of
the infrared sensor 3804 by the power-initializer 3802, such as a
delay of a minimum of 340 ms (+20 ms) to a maximum of 360 ms.
[0286] Apparatus 3800 includes a voltage level measurer 3808 of the
infrared sensor 3804 that outputs a representation of the sensor
voltage level 3810 of the infrared sensor 3804. When the sensor
voltage level 3810 is below 2.7V or is above 3.5V, a reading error
message 3812 is generated and displayed.
[0287] Apparatus 3800 also includes a sensor controller 3814 that
initiates four infrared measurements 3816 of the forehead surface
by the infrared sensor 3804 and receives the four infrared
measurements 3816. In some implementations, each of the four
infrared measurements 3816 of the forehead surface are performed by
the infrared sensor 3804 with a period of at least 135 ms (+20 ms)
to a maximum of 155 ms between each of the infrared measurements
3816.
[0288] If one of the up to 15 infrared measurements 3816 of the
forehead surface by the infrared sensor 3804 that is received is
invalid, a reading error message 3812 is displayed.
[0289] Apparatus 3800 also includes an ambient air temperature
controller 3818 that initiates an ambient air temperature (Ta)
measurement 3820 and receives the ambient air temperature (Ta)
measurement 3820. If the ambient air temperature (Ta) measurement
3820 of the ambient air temperature is invalid, a reading error
message 3812 is displayed. The ambient air temperature controller
3818 compares the ambient air temperature (Ta) measurement 3820 to
a range of acceptable values, such as the numerical range of
283.15K (10.degree. C.) to 313.15.degree. K (40.degree. C.). If the
ambient air temperature (Ta) measurement 3820 is outside of this
range, a reading error message 3812 is displayed. The sensor
controller 3814 compares all four of the infrared measurements 3816
of the forehead surface by the infrared sensor 3804 to determine
whether or not are all four are within 1 Kelvin degree of each
other. If all four infrared measurements of the forehead surface by
the infrared sensor 3804 are not within 1 Kelvin degree of each
other, a reading error message 3812 is displayed.
[0290] The sensor controller 3814 averages the four infrared
measurements of the forehead surface to provide a received object
temperature (Tobj) 3822 when all four infrared measurements of the
forehead surface by the infrared sensor 3804 are within 1 degree
Kelvin of each other. The sensor controller 3814 also generates a
voltage-corrected ambient air temperature (COvTa) 3824 and a
voltage-corrected object temperature (COvTobj) 3826 by applying a
sensor voltage correction 3828 to the ambient air temperature (Ta)
and the object temperature (Tobj) 3822, respectively. For example,
the sensor voltage correction 3828 in Kelvin=object temperature
(Tobj)-(voltage at sensor-3.00)*0.65. In some implementations, a
sensor calibration offset is applied to the voltage-corrected
object temperature (COvTobj), resulting in a calibration-corrected
voltage-corrected object temperature (COcaCOvTobj) 3830. For
example, a sensor calibration offset of 0.60 Kelvin is added to
each voltage-corrected object temperature (COvTobj) from the
infrared sensor 3804 of a particular manufacturer.
[0291] An estimated body core temperature generator 3832 reads an
estimated body core temperature 3834 from one or more tables 3836
that are stored in a memory 3838 (such as memory 3838 in FIG. 38)
that correlates the calibration-corrected voltage-corrected object
temperature (COcaCOvTobj) to the body core temperature in reference
to the voltage-corrected ambient air temperature (COvTa) 3824. One
implementation of the estimated body core temperature generator
3832 in FIG. 38 is apparatus 3900 in FIG. 39. The tables 3836 are
also known as body core temperature correlation tables.
[0292] A scale converter 3840 converts the estimated body core
temperature 3834 from Kelvin to .degree. C. or .degree. F.,
resulting in a converted body core temperature 3842. There is a
specific algorithm for pediatrics (<=8 years old) to account for
the different physiological response of children in the febrile
>101 degF range.
[0293] FIG. 39-40 are block diagrams of an apparatus 3900 to derive
an estimated body core temperature from one or more tables that are
stored in a memory that correlate a calibration-corrected
voltage-corrected object temperature to the body core temperature
in reference to the corrected ambient air temperature, according to
an implementation. Apparatus 3900 is one implementation of the
estimated body core temperature generator 3832 in FIG. 38.
[0294] Apparatus 3900 includes an ambient air temperature
operating-range comparator 3902 that is configured to compare the
voltage-corrected ambient air temperature (COvTa) (3824 in FIG. 38)
to an operational temperature range of the apparatus to determine
whether or not the voltage-corrected ambient air temperature
(COvTa) 3824 is outside of the operational temperature range of the
apparatus. The operational temperature range is from the lowest
operational temperature of the apparatus 3900 to the highest
operational temperature of the MVS system 3000. In one example, the
operational temperature range is 10.0.degree. C. to 40.0.degree. C.
In a further example, if the voltage-corrected ambient air
temperature (COvTa) is 282.15.degree. K (9.0.degree. C.), which is
less than the exemplary lowest operational temperature
(10.0.degree. C.), then the voltage-corrected ambient air
temperature (COvTa) is outside of the operational temperature
range.
[0295] Apparatus 3900 includes an ambient air temperature
table-range comparator 3904 that determines whether or not the
voltage-corrected ambient air temperature (COvTa) 3824 is outside
of the range of the tables. For example, if the voltage-corrected
ambient air temperature (COvTa) is 287.15.degree. K (14.0.degree.
C.), which is less than the lowest ambient air temperature in the
tables, then the voltage-corrected ambient air temperature (COvTa)
is outside of the range of the tables. In another example, if the
voltage-corrected ambient air temperature (COvTa) is 312.25.degree.
K (39.1.degree. C.), which is greater than the highest ambient air
temperature (37.9.degree. C.) of all of the tables, then the
voltage-corrected ambient air temperature (COvTa) is outside of the
range of the tables.
[0296] When the ambient air temperature table-range comparator 3904
determines that the voltage-corrected ambient air temperature
(COvTa) 3824 is outside of the range of the tables, then control
passes to an ambient air temperature range-bottom comparator 3906
that is configured to compare the voltage-corrected ambient air
temperature (COvTa) (3924 in FIG. 38) to the bottom of the range of
the tables to determine whether or not the voltage-corrected
ambient air temperature (COvTa) 3824 is less than the range of the
tables. The bottom of the range of the tables is the lowest ambient
air temperature of all of the tables, such as 14.6.degree. C. In a
further example, if the voltage-corrected ambient air temperature
(COvTa) is 287.15.degree. K (14.0.degree. C.), which is less than
the lowest ambient air temperature (14.6.degree. C.) of the tables,
then the voltage-corrected ambient air temperature (COvTa) is less
than the bottom of the range of the tables.
[0297] When the ambient air temperature range-bottom comparator
3906 determines that the voltage-corrected ambient air temperature
(COvTa) 3824 is less than the range of the tables, control passes
to an estimated body core temperature calculator for hypo ambient
air temperatures 3908 sets the estimated body core temperature 3834
to the calibration-corrected voltage-corrected object temperature
(COcaCOvTobj) 3830+0.19.degree. K for each degree that the
voltage-corrected ambient air temperature (COvTa) is below the
lowest ambient body core table.
[0298] For example, when the voltage-corrected ambient air
temperature (COvTa) is 12.6.degree. C., which is less than the
range of the tables, 14.6.degree. C., and the calibration-corrected
voltage-corrected object temperature (COcaCOvTobj) 3830 is
29.degree. C. (302.15.degree. K) then the estimated body core
temperature calculator for hypo ambient air temperatures 3908 sets
the estimated body core temperature 3834 to 302.15.degree.
K+(0.19.degree. K*(14.6.degree. C.-12.6.degree. C.)), which is
302.53.degree. K.
[0299] When the ambient air temperature range-bottom comparator
3906 determines that the voltage-corrected ambient air temperature
(COvTa) 3824 is not less than the range of the tables, control
passes to an estimated body core temperature calculator 3910 for
hyper ambient air temperatures that sets the estimated body core
temperature 3834 to the calibration-corrected voltage-corrected
object temperature (COcaCOvTobj) 3830-0.13.degree. K for each
degree that the voltage-corrected ambient air temperature (COvTa)
is above the highest ambient body core table.
[0300] For example, when the voltage-corrected ambient air
temperature (COvTa) is 45.9.degree. C., which is above the range of
all of the tables, (43.9.degree. C.), and the calibration-corrected
voltage-corrected object temperature (COcaCOvTobj) 3830 is
29.degree. C. (302.15.degree. K) then the estimated body core
temperature calculator 3910 for hyper ambient air temperatures sets
the estimated body core temperature 3834 to 302.15.degree.
K-(0.13.degree. K*(45.9.degree. C.-43.9.degree. C.)), which is
301.89.degree. K.
[0301] When the ambient air temperature table-range comparator 3904
determines that the voltage-corrected ambient air temperature
(COvTa) 3824 is not outside of the range of the tables, then
control passes to an ambient air temperature table comparator 3912
that determines whether or not the voltage-corrected ambient air
temperature (COvTa) is exactly equal to the ambient air temperature
of one of the tables, when the estimated body core temperature
calculator 3910 for hyper ambient air temperatures determines that
the voltage-corrected ambient air temperature (COvTa) is within of
the range of the tables. When the ambient air temperature table
comparator 3912 determines that the voltage-corrected ambient air
temperature (COvTa) is exactly equal to the ambient air temperature
of one of the tables, then the estimated body core temperature
table value selector for exact ambient air temperatures 3914 sets
the estimated body core temperature 3834 to the body core
temperature of that one table, indexed by the calibration-corrected
voltage-corrected object temperature (COcaCOvTobj) 3830.
[0302] For example, when the voltage-corrected ambient air
temperature (COvTa) is 34.4.degree. C. (the ambient air temperature
of Table D) and the calibration-corrected voltage-corrected object
temperature (COcaCOvTobj) 3830 is 29.1.degree. C., then the
estimated body core temperature table value selector for exact
ambient air temperatures 3914 sets the estimated body core
temperature 3834 to 29.85 C, which is the body core temperature of
Table D indexed at the calibration-corrected voltage-corrected
object temperature (COcaCOvTobj) 3830 of 29.1.degree. C.
[0303] Apparatus 3900 includes a table interpolation selector 3916.
When the ambient air temperature table comparator 3912 determines
that the voltage-corrected ambient air temperature (COvTa) is not
exactly equal to the ambient air temperature of one of the tables,
then the table interpolation selector 3916 identifies the two
tables which the voltage-corrected ambient air temperature (COvTa)
falls between.
[0304] For example, if the voltage-corrected ambient air
temperature (COvTa) is 293.25.degree. K (20.1.degree. C.), this
ambient value falls between the tables for ambient air temperatures
of 19.6.degree. C. and 24.6.degree. C., in which case, the
19.6.degree. C. table is selected as the Lower Body Core Table and
the 24.6.degree. C. table is selected as the Higher Body Core
Table.
[0305] Thereafter, apparatus 3900 includes a table interpolation
weight calculator 3920 that calculates a weighting between the
lower table and the higher table, the table interpolation weights
3922.
[0306] For example, when Tamb_bc_low (the voltage-corrected ambient
air temperature (COvTa) for the Lower Body Core Table)=19.6.degree.
C. and T amb_bc_high (the voltage-corrected ambient air temperature
(COvTa) for the Higher Body Core Table)=24.6 C, then the
amb_diff=(Tamb_bc_high-Tamb_bc_low/100)=(24.6-19.6)/100=0.050.degree.
C. Further, the Higher Table
Weighting=100/((Tamb-Tamb_bc_low)/amb_diff)=100/((20.1-19.6)/0.050)=10%
and the Lower Table Weighting=100-Higher Table
Weighting=100-10=90%.
[0307] Apparatus 3900 includes a body core temperature reader 3924
that reads the core body core temperature that is associated with
the sensed forehead temperature from each of the two tables, the
Lower Body Core Table and the Higher Body Core Table. The
calibration-corrected voltage-corrected object temperature
(COcaCOvTobj) 3830 is used as the index into the two tables.
[0308] Apparatus 3900 also includes a correction value calculator
3926 that calculates a correction value 3928 for each of the Lower
Body Core Table and the Higher Body Core Table. For example, where
each of the tables has an entry of calibration-corrected
voltage-corrected object temperature (COcaCOvTobj) 3830 for each
0.1.degree. Kelvin, to calculate to a resolution of 0.01.degree.
Kelvin, the linear difference is applied to the two table values
that the calibration-corrected voltage-corrected object temperature
(COcaCOvTobj) 3830 falls between.
[0309] For example, when the calibration-corrected
voltage-corrected object temperature (COcaCOvTobj) 3830 is
309.03.degree. K, then the calibration-corrected voltage-corrected
object temperature (COcaCOvTobj) 3830 falls between 309.00 and
309.10. The correction value 3928 is equal to a+((b-a)*0.03), where
a=body core correction value for 309.0.degree. K and b=body curve
correction value for 309.1.degree. K.
[0310] Thereafter, apparatus 3900 includes an estimated body core
temperature calculator for interpolated tables 3930 that determines
the body core temperature of the sensed forehead temperature in
reference to the ambient air temperature by summing the weighted
body core temperatures from the two tables. The estimated body core
temperature is determined to equal (Tcor_low*Lower Table
Weighting/100)+(Tcor_high*Higher Table Weighting/100).
[0311] For example, when the voltage-corrected ambient air
temperature (COvTa) is 293.25.degree. K (20.10.degree. C.), then in
this case 90% (90/100) of the Table) and 10% (10/100) are summed to
set the estimated body core temperature 3834.
[0312] The comparator 3902, comparator 3904 and comparator 3906 can
be arranged in any order relative to each other.
[0313] FIG. 41 is a block diagram of a digital infrared sensor
1312, according to an implementation. The digital infrared sensor
1312 contains a single thermopile sensor 4102 that senses only
infrared electromagnetic energy 4104. The digital infrared sensor
1312 contains a CPU control block 4106 and an ambient air
temperature sensor 4108, such as a thermocouple. The single
thermopile sensor 4102, the ambient air temperature sensor 4108 and
the CPU control block 4106 are on separate silicon substrates 4110,
4112 and 4114 respectively. The CPU control block 4106 digitizes
the output of the single thermopile sensor 4102 and the ambient air
temperature sensor 4108.
[0314] The digital infrared sensor 1312 has a Faraday cage 4116
surrounding the single thermopile sensor 4102, the CPU control
block 4106 and the ambient air temperature sensor 4108 to prevent
electromagnetic (EMF) interference in the single thermopile sensor
4102, the CPU control block 4106 and the ambient air temperature
sensor 4108 that shields the components in the Faraday cage 4116
from outside electromagnetic interference, which improves the
accuracy and the repeatability of a device that estimates body core
temperature from the ambient and object temperature generated by
the digital infrared sensor 1312. The digital IR sensor 1312 also
requires less calibration in the field after manufacturing, and
possibly no calibration in the field after manufacturing because in
the digital infrared sensor 1312, the single thermopile sensor
4102, the CPU control block 4106 and the ambient air temperature
sensor 4108 are in close proximity to each other, which lowers
temperature differences between the single thermopile sensor 4102,
the CPU control block 4106 and the ambient air temperature sensor
4108, which minimizes or eliminates calibration drift over time
because they are based on the same substrate material and exposed
to the same temperature and voltage variations. In comparison,
conventional infrared temperature sensors do not include a Faraday
cage 4116 that surrounds the single thermopile sensor 4102, the CPU
control block 4106 and the ambient air temperature sensor 4108. The
Faraday cage 4116 can be a metal box or a metal mesh box. In the
implementation where the Faraday cage 4116 is a metal box, the
metal box has an aperture where the single thermopile sensor 4102
is located so that the field of view of the infrared
electromagnetic energy 4104 is not affected by the Faraday cage
4116 so that the infrared electromagnetic energy 4104 can pass
through the Faraday cage 4116 to the single thermopile sensor 4102.
In the implementation where the Faraday cage 4116 is a metal box,
the metal box has an aperture where the ambient air temperature
sensor 4108 is located so that the atmosphere can pass through the
Faraday cage 4116 to the ambient air temperature sensor 4108. In
other implementations the ambient air temperature sensor 4108 does
not sense the temperature of the atmosphere, but instead senses the
temperature of the sensor substrate (silicon) material and
surrounding materials because the ambient air temperature sensor
4108 and the target operating environment temperature are required
to be as close as possible in order to reduce measurement error,
i.e. the ambient air temperature sensor 4108 is to be in thermal
equilibrium with the target operating environment.
[0315] In some further implementations, the Faraday cage 4116 of
the digital infrared sensor 1312 also includes an multichannel
analogue-to-digital converter (ADC) 4118 that digitizes an analogue
signal from the single thermopile sensor 4102. The ADC 4118 also
digitizes an analogue signal from the ambient air temperature
sensor 4108. In another implementation where the ADC is not a
multichannel ADC, separate ADCs are used to digitize the analogue
signal from the single thermopile sensor 4102 and the analogue
signal from the ambient air temperature sensor 4108. There is no
ADC between the digital infrared sensor 1312 and microprocessor(s),
main processor(s) and controller(s) that are outside the digital IR
sensor 1312, such as the microprocessor 3502 in FIG. 35.
[0316] The single thermopile sensor 4102 of the digital infrared
sensor 1312 is tuned to be most sensitive and accurate to the human
body core temperature range, such as forehead surface temperature
range of 25.degree. C. to 39.degree. C. The benefits of the digital
IR sensor 1312 in comparison to conventional analogue infrared
temperature sensors include minimization of the temperature
difference between the analogue and digital components effects on
calibration parameters (when the temperature differences are close
there is a smaller .DELTA.T which mimics the calibration
environment) and reduction of EMC interference in the datalines.
The digital infrared sensor 1312 outputs a digital representation
of the surface temperature in absolute Kelvin degrees (.degree. K)
that is presented at a digital readout port of the digital infrared
sensor 1312. The digital representation of the surface temperature
is also known as the body surface temperature in FIG. 41, digital
readout signal 3511 in FIG. 35, digital signal that is
representative of an infrared signal of a forehead temperature that
is detected by the digital infrared sensor in FIG. 59, the body
core temperature in FIG. 33, the temperature measurement in FIG.
61, the sensed forehead temperature in FIG. 38 and the numerical
representation of the electromagnetic energy of the external source
point in FIG. 63.
[0317] The digital infrared sensor 1312 is not an analog device or
component, such as a thermistor or a resistance temperature
detector (RTD). Because the digital infrared sensor 1312 is not a
thermistor, there is no need or usefulness in receiving a reference
signal of a resister and then determining a relationship between
the reference signal and a temperature signal to compute the
surface temperature. Furthermore, the digital infrared sensor 1312
is not an array of multiple transistors as in complementary metal
oxide (CMOS) devices or charged coupled (CCD) devices. None of the
subcomponents in the digital infrared sensor 1312 detect
electromagnetic energy in wavelengths of the human visible spectrum
(380 nm-750 nm). Neither does the digital infrared sensor 1312
include an infrared lens.
[0318] FIG. 42 is a block diagram of a pneumatic system components
4200, according to an implementation. The pneumatic system
components 4200 is one component of the MVS finger cuff 3006 in
Fig. The pneumatic system components 4200 are in the MVSFCA 3002,
MVSFCA 3102, MVSFCSS 3300, MVSFCA 1900 and the front end of a MVS
finger cuff 2000.
[0319] The pneumatic system components 4200 includes a pneumatic
pump 4204 that is mechanically coupled to an inflatable cuff
bladder, such as inflatable cuff bladder 6806 that provides air
pressure to inflate the inflatable cuff bladder in the finger
occlusion cuff 3016 in FIG. 30. The inflatable cuff bladder 6806 is
mechanically coupled to the pneumatic pump 4204 via an air line
421404. The inflatable cuff bladder 6806 is mechanically coupled to
a pressure sensor 4208 that measures pneumatic pressure in the
inflatable cuff bladder 6806. The air line 4206 is mechanically
coupled to a valve 1406 that controls pressure from the pneumatic
pump 4204 to the inflatable cuff bladder 6806. The pneumatic system
components 4200 is one implementation of the pneumatic engine 3005
and the pneumatic engine 1906.
[0320] FIG. 43 is a block diagram of a solid-state image transducer
2852, according to an implementation. The solid-state image
transducer 2852 includes a great number of photoelectric elements,
a.sub.1..sub.1, a.sub.2..sub.1, . . . , a.sub.mn, in the minute
segment form, transfer gates TG1, TG2, . . . , TGn responsive to a
control pulse V.sub..phi.P for transferring the charges stored on
the individual photoelectric elements as an image signal to
vertical shift registers VS1, VS2, . . . , VSn, and a horizontal
shift register HS for transferring the image signal from the
vertical shift registers VSs, through a buffer amplifier 2d to an
outlet 2e. After the one-frame image signal is stored, the image
signal is transferred to vertical shift register by the pulse
V.sub..phi.P and the contents of the vertical shift registers VSs
are transferred upward line by line in response to a series of
control pulses V.sub..phi.V1, V.sub..phi.V2. During the time
interval between the successive two vertical transfer control
pulses, the horizontal shift register HS responsive to a series of
control pulses V.sub. .phi.H1, V.sub..phi.H2 transfers the contents
of the horizontal shift registers HSs in each line row by row to
the right as viewed in FIG. 43. As a result, the one-frame image
signal is formed by reading out the outputs of the individual
photoelectric elements in such order.
[0321] FIG. 44 is a block diagram of a wireless communication
system 4400, according to an implementation. The wireless
communication system 4400 includes a communication subsystem 2804
that includes a receiver 4401, a transmitter 4402, as well as
associated components such as one or more embedded or antennas 4404
and 4406, Local Oscillators (LOs) 4408, and a processing module
such as a digital signal processor (DSP) 4410. The particular
implementation of the wireless communication subsystem 2804 is
dependent upon communication protocols of a wireless network 2805
with which the mobile device is intended to operate. Thus, it
should be understood that the implementation illustrated in FIG. 44
serves only as one example. Examples of the mobile device include
MVS smartphone 2800, MVS smartphone system in FIG. 3031 and MVS
smartphone in FIG. 28-34. Examples of the wireless network 4405
include network 2805 in FIG. 28.
[0322] Signals received by the antenna 4404 through the wireless
network 4405 are input to the receiver 4401, which may perform such
common receiver functions as signal amplification, frequency down
conversion, filtering, channel selection, and analog-to-digital
(A/D) conversion. A/D conversion of a received signal allows more
complex communication functions such as demodulation and decoding
to be performed in the DSP 4410. In a similar manner, signals to be
transmitted are processed, including modulation and encoding, by
the DSP 4410. These DSP-processed signals are input to the
transmitter 4402 for digital-to-analog (D/A) conversion, frequency
up conversion, filtering, amplification and transmission over the
wireless network 4405 via the antenna 4406. The DSP 4410 not only
processes communication signals, but also provides for receiver and
transmitter control. For example, the gains applied to
communication signals in the receiver 4401 and the transmitter 4402
may be adaptively controlled through automatic gain control
algorithms implemented in the DSP 4410.
[0323] The wireless link between the MVS apparatus 5504 and the
wireless network 4405 can contain one or more different channels,
typically different RF channels, and associated protocols used
between the MVS apparatus 5504 and the wireless network 4405. An RF
channel is a limited resource that must be conserved, typically due
to limits in overall bandwidth and limited battery power of the MVS
apparatus 5504.
[0324] When the MVS apparatus 5504 are fully operational, the
transmitter 4402 is typically keyed or turned on only when it is
transmitting to the wireless network 4405 and is otherwise turned
off to conserve resources. Similarly, the receiver 4401 is
periodically turned off to conserve power until the receiver 4401
is needed to receive signals or information (if at all) during
designated time periods.
[0325] Each patient record 4412 is received by the wireless
communication subsystem 2804 from the main processor 2802 at the
DSP 4410 and then transmitted to the wireless network 4405 through
the antenna 4404 of the receiver 4401. In some implementations,
each patient record 4412 is a patient file that is managed or
controlled by an ambulatory medical facility or a private medical
office, such as a Patient Portal Medical Record or a
Patient-Generated Health Data (PGHD)) and conforms to the Patient
Care Device Technical Framework standard published by the
Integrating the Healthcare Enterprise of 820 Jorie Boulevard, Oak
Brook, Ill. 60523 or the Fundamentals of Data Exchange standard
published by the Personal Connected Health Alliance of 4300 Wilson
Boulevard--Suite 250, Arlington, Va. 22203, or data exchange
requirement of various EHR and EMR vendors.
[0326] FIG. 45 is a block diagram of an apparatus 4500 to generate
a predictive analysis of vital signs, according to an
implementation. The apparatus 4500 can be implemented on the MVS
finger cuff accessory (MVSFCA) 3002 in FIG. 30, the MVS smartphone
(MVS Smartphone) 3004 in FIG. 30, the MVS finger cuff accessory
(MVSFCA) 3102 in FIG. 31 or the MVS smartphone 3103 in FIG. 31, the
sensor management component 3302 in FIG. 33, the microprocessor
3320 in FIG. 33, the MVS finger cuff 1904 in FIG. 19 and FIG. 7,
the microprocessor 1902 in FIG. 19, controller 2020 in FIG. 20, the
microprocessor 3402 in FIG. 34 and/or main processor 2802 in FIG.
28. In apparatus 4500, blood glucose levels 4501, heartrate data
4502, respiratory rate data 4504, estimated body core temperature
data 4506 (such as estimated body core temperature 3520 in FIG. 35
or estimated body core temperature 3612 in FIG. 38-40), blood
pressure data 4508 (such as blood pressure 5222 in FIG. 52), EKG
data 4510 (such as EKG 5228 in FIG. 52) and/or SpO2 data 4512 is
received by a predictive analysis component 4514 that evaluates the
data 4501, 4502, 4504, 4506, 4508, 4510 and/or 4512 in terms of
percentage change over time. More specifically, the relative change
and the rate of change or change in comparison to an established
pattern that is described in terms of frequency and amplitude. When
the percentage change over time exceeds a predetermined threshold,
a flag 4516 is set to indicate an anomaly. The flag 4516 can be
transmitted to the EMR/clinical data repository 5544, as shown in
FIG. 55-57.
[0327] FIG. 46 is a block diagram of an apparatus 4600 of motion
amplification, according to an implementation. Apparatus 4600
analyzes the temporal and spatial variations in digital images of
an animal subject in order to generate and communicate biological
vital signs.
[0328] In some implementations, apparatus 4600 includes a forehead
skin-pixel-identification module 4602 that identifies pixel-values
that are representative of the skin in two or more images 2854. The
pixel-values are the values of the pixels in the images 2854. In
some implementations the images 2854 are frames of a video. The
forehead skin-pixel-identification module 4602 performs block 5404
in FIG. 54. Some implementations of the forehead
skin-pixel-identification module 4602 perform an automatic seed
point based clustering process on the two or more images 2854. In
some implementations, apparatus 4600 includes a frequency filter
4606 that receives the output of the forehead
skin-pixel-identification module 4602 and applies a frequency
filter to the output of the forehead skin-pixel-identification
module 4602. The frequency filter 4606 performs block 5406 in FIG.
54 to process the images 2854 in the frequency domain. In
implementations where the apparatus in FIG. 46-54 are implemented
on MVS smartphone systems and MVS smartphone systems having an
infrared sensor in FIG. 30-34, the images 2854 in FIG. 46-54 are
the images 2854 in FIG. 35-40. In some implementations the
apparatus in FIG. 46-54 are implemented on the MVS smartphone 2800
in FIG. 28.
[0329] In some implementations, apparatus 4600 includes a regional
facial clusterial module 4608 that includes a spatial clusterer
that is applied to the output of the frequency filter 4606. The
regional facial clusterial module 4608 performs block 5408 in FIG.
54. In some implementations the regional facial clusterial module
4608 includes fuzzy clustering, k-means clustering,
expectation-maximization process, Ward's apparatus or seed point
based clustering.
[0330] In some implementations, apparatus 4600 includes a
frequency-filter 4610 that applies a frequency filter to the output
of the regional facial clusterial module 4608. The frequency-filter
4610 performs block 5410 in FIG. 54. In some implementations, the
frequency-filter 4610 is a one-dimensional spatial Fourier
Transform, a high pass filter, a low pass filter, a bandpass filter
or a weighted bandpass filter. Some implementations of
frequency-filter 4610 includes de-noising (e.g. smoothing of the
data with a Gaussian filter). The forehead
skin-pixel-identification module 4602, the frequency filter 4606,
the regional facial clusterial module 4608 and the frequency-filter
4610 amplify temporal motion (as a temporal-motion-amplifier) in
the two or more images 2854.
[0331] In some implementations, apparatus 4600 includes a
temporal-motion identifier 4612 that identifies temporal motion of
the output of the frequency-filter 4610. Thus, the temporal motion
represents temporal motion of the images 2854. The temporal-motion
identifier 4612 performs block 5412 in FIG. 54.
[0332] In some implementations, apparatus 4600 includes a
biological vital-sign generator 4614 that generates one or more
biological vital sign(s) 4616 from the temporal motion. The
biological vital sign(s) 4616 are displayed for review by a
healthcare worker or stored in a volatile or nonvolatile memory for
later analysis, or transmitted to other devices for analysis.
[0333] Fuzzy clustering is a class of processes for cluster
analysis in which the allocation of data points to clusters is not
"hard" (all-or-nothing) but "fuzzy" in the same sense as fuzzy
logic. Fuzzy logic being a form of many-valued logic which with
reasoning that is approximate rather than fixed and exact. In fuzzy
clustering, every point has a degree of belonging to clusters, as
in fuzzy logic, rather than belonging completely to just one
cluster. Thus, points on the edge of a cluster, may be in the
cluster to a lesser degree than points in the center of cluster.
Any point x has a set of coefficients giving the degree of being in
the kth cluster w.sub.k(x). With fuzzy c-means, the centroid of a
cluster is the mean of all points, weighted by a degree of
belonging of each point to the cluster:
c k = x w k ( x ) m x x w k ( x ) m . ##EQU00006##
[0334] The degree of belonging, w.sub.k(x), is related inversely to
the distance from x to the cluster center as calculated on the
previous pass. The degree of belonging, w.sub.k(x) also depends on
a vital-sign m that controls how much weight is given to the
closest center.
[0335] k-means clustering is a process of vector quantization,
originally from signal processing, that is popular for cluster
analysis in data mining k-means clustering partitions in
observations into k clusters in which each observation belongs to
the cluster with the nearest mean, serving as a prototype of the
cluster. This results in a partitioning of the data space into
Voronoi cells. A Voronoi Cell being a region within a Voronoi
Diagram that is a set of points which is specified beforehand. A
Voronoi Diagram is a technique of dividing space into a number of
regions. k-means clustering uses cluster centers to model the data
and tends to find clusters of comparable spatial extent, like
K-means clustering, but each data point has a fuzzy degree of
belonging to each separate cluster.
[0336] An expectation-maximization process is an iterative process
for finding maximum likelihood or maximum a posteriori (MAP)
estimates of vital-signs in statistical models, where the model
depends on unobserved latent variables. The
expectation-maximization iteration alternates between performing an
expectation step, which creates a function for the expectation of
the log-likelihood evaluated using the current estimate for the
vital-signs, and a maximization step, which computes vital-signs
maximizing the expected log-likelihood found on the expectation
step. These vital-sign-estimates are then used to determine the
distribution of the latent variables in the next expectation
step.
[0337] The expectation maximization process seeks to find the
maximization likelihood expectation of the marginal likelihood by
iteratively applying the following two steps:
[0338] 1. Expectation step (E step): Calculate the expected value
of the log likelihood function, with respect to the conditional
distribution of Z given X under the current estimate of the
vital-signs .theta..sup.(t):
Q(.theta.|.theta..sup.(t))=E.sub.Z|X,.theta..sub.(t)[log
L(.theta.;X,Z)]
[0339] 2. Maximization step (M step): Find the vital-sign that
maximizes this quantity:
.theta. ( t + 1 ) = arg max .theta. Q ( .theta. | .theta. ( t ) )
##EQU00007##
[0340] Note that in typical models to which expectation
maximization is applied:
[0341] 1. The observed data points X may be discrete (taking values
in a finite or countably infinite set) or continuous (taking values
in an uncountably infinite set). There may in fact be a vector of
observations associated with each data point.
[0342] 2. The missing values (aka latent variables) Z are discrete,
drawn from a fixed number of values, and there is one latent
variable per observed data point.
[0343] 3. The vital-signs are continuous, and are of two kinds:
Vital-signs that are associated with all data points, and
vital-signs associated with a particular value of a latent variable
(i.e. associated with all data points whose corresponding latent
variable has a particular value).
[0344] The Fourier Transform is an important image processing tool
which is used to decompose an image into its sine and cosine
components. The output of the transformation represents the image
in the Fourier or frequency domain, while the input image is the
spatial domain equivalent. In the Fourier domain image, each point
represents a particular frequency contained in the spatial domain
image.
[0345] The Discrete Fourier Transform is the sampled Fourier
Transform and therefore does not contain all frequencies forming an
image, but only a set of samples which is large enough to fully
describe the spatial domain image. The number of frequencies
corresponds to the number of pixels in the spatial domain image,
i.e. the image in the spatial and Fourier domains are of the same
size.
[0346] For a square image of size N.times.N, the two-dimensional
DFT is given by:
F ( k , l ) = i = 0 N - 1 j = 0 N - 1 f ( i , j ) e - 2.pi. ( ki N
+ j N ) ##EQU00008##
[0347] where f(a,b) is the image in the spatial domain and the
exponential term is the basis function corresponding to each point
F(k,l) in the Fourier space. The equation can be interpreted as:
the value of each point F(k,l) is obtained by multiplying the
spatial image with the corresponding base function and summing the
result.
[0348] The basis functions are sine and cosine waves with
increasing frequencies, i.e. F(0,0) represents the DC-component of
the image which corresponds to the average brightness and
F(N-1,N-1) represents the highest frequency.
[0349] A high-pass filter (HPF) is an electronic filter that passes
high-frequency signals but attenuates (reduces the amplitude of)
signals with frequencies lower than the cutoff frequency. The
actual amount of attenuation for each frequency varies from filter
to filter. A high-pass filter is usually modeled as a linear
time-invariant system. A high-pass filter can also be used in
conjunction with a low-pass filter to make a bandpass filter. The
simple first-order electronic high-pass filter is implemented by
placing an input voltage across the series combination of a
capacitor and a resistor and using the voltage across the resistor
as an output. The product of the resistance and capacitance
(R.times.C) is the time constant (.tau.); the product is inversely
proportional to the cutoff frequency f.sub.c, that is:
f c = 1 2 .pi..tau. = 1 2 .pi. RC , ##EQU00009##
[0350] where f.sub.c is in hertz, .tau. is in seconds, R is in
ohms, and C is in farads.
[0351] A low-pass filter is a filter that passes low-frequency
signals and attenuates (reduces the amplitude of) signals with
frequencies higher than the cutoff frequency. The actual amount of
attenuation for each frequency varies depending on specific filter
design. Low-pass filters are also known as high-cut filter, or
treble cut filter in audio applications. A low-pass filter is the
opposite of a high-pass filter. Low-pass filters provide a smoother
form of a signal, removing the short-term fluctuations, and leaving
the longer-term trend. One simple low-pass filter circuit consists
of a resistor in series with a load, and a capacitor in parallel
with the load. The capacitor exhibits reactance, and blocks
low-frequency signals, forcing the low-frequency signals through
the load instead. At higher frequencies the reactance decreases,
and the capacitor effectively functions as a short circuit. The
combination of resistance and capacitance gives the time constant
of the filter. The break frequency, also called the turnover
frequency or cutoff frequency (in hertz), is determined by the time
constant.
[0352] A band-pass filter is a device that passes frequencies
within a certain range and attenuates frequencies outside that
range. These filters can also be created by combining a low-pass
filter with a high-pass filter. Bandpass is an adjective that
describes a type of filter or filtering process; bandpass is
distinguished from passband, which refers to the actual portion of
affected spectrum. Hence, a dual bandpass filter has two passbands.
A bandpass signal is a signal containing a band of frequencies not
adjacent to zero frequency, such as a signal that comes out of a
bandpass filter.
[0353] FIG. 47 is a block diagram of an apparatus 4700 of motion
amplification, according to an implementation. Apparatus 4700
analyzes the temporal and spatial motion in digital images of an
animal subject in order to generate and communicate biological
vital signs.
[0354] In some implementations, apparatus 4700 includes a forehead
skin-pixel-identification module 4602 that identifies pixel-values
that are representative of the skin in two or more images 2854. The
forehead skin-pixel-identification module 4602 performs block 5404
in FIG. 54. Some implementations of the forehead
skin-pixel-identification module 4602 performs an automatic seed
point based clustering process on the images 2854.
[0355] In some implementations, apparatus 4700 includes a frequency
filter 4606 that receives the output of the forehead
skin-pixel-identification module 4602 and applies a frequency
filter to the output of the forehead skin-pixel-identification
module 4602. The frequency filter 4606 performs block 5406 in FIG.
54 to process the images 2854 in the frequency domain
[0356] In some implementations, apparatus 4700 includes a regional
facial clusterial module 4608 that includes a spatial clusterer
that is applied to the output of the frequency filter 4606. The
regional facial clusterial module 4608 performs block 5408 in FIG.
54. In some implementations the regional facial clusterial module
4608 includes fuzzy clustering, k-means clustering,
expectation-maximization process, Ward's apparatus or seed point
based clustering.
[0357] In some implementations, apparatus 4700 includes a
frequency-filter 4610 that applies a frequency filter to the output
of the regional facial clusterial module 4608, to generate a
temporal motion. The frequency-filter 4610 performs block 54010 in
FIG. 54. In some implementations, the frequency-filter 4610 is a
one-dimensional spatial Fourier Transform, a high pass filter, a
low pass filter, a bandpass filter or a weighted bandpass filter.
Some implementations of frequency-filter 4610 includes de-noising
(e.g. smoothing of the data with a Gaussian filter). The forehead
skin-pixel-identification module 4602, the frequency filter 4606,
the regional facial clusterial module 4608 and the frequency-filter
4610 amplify temporal motion in the two or more images 2854.
[0358] In some implementations, apparatus 4700 includes a
biological vital-sign generator 4614 that generates one or more
biological vital sign(s) 4616 from the temporal motion. The
biological vital sign(s) 4616 are displayed for review by a
healthcare worker or stored in a volatile or nonvolatile memory for
later analysis, or transmitted to other devices for analysis.
[0359] FIG. 48 is a block diagram of an apparatus 4800 of motion
amplification, according to an implementation. Apparatus 4800
analyzes the temporal and spatial motion in digital images of an
animal subject in order to generate and communicate biological
vital signs.
[0360] In some implementations, apparatus 4800 includes a forehead
skin-pixel-identification module 4602 that identifies pixel-values
that are representative of the skin in two or more images 2854. The
forehead skin-pixel-identification module 4602 performs block 5404
in FIG. 54. Some implementations of the forehead
skin-pixel-identification module 4602 performs an automatic seed
point based clustering process on the images 2854.
[0361] In some implementations, apparatus 4800 includes a spatial
bandpass filter 4802 that receives the output of the forehead
skin-pixel-identification module 4602 and applies a spatial
bandpass filter to the output of the forehead
skin-pixel-identification module 4602. The spatial bandpass filter
4802 performs blocks 5410 and 5412 in FIG. 54 to process the images
2854 in the spatial domain.
[0362] In some implementations, apparatus 4800 includes a regional
facial clusterial module 4608 that includes a spatial clusterer
that is applied to the output of the frequency filter 4606. In some
implementations the regional facial clusterial module 4608 includes
fuzzy clustering, k-means clustering, expectation-maximization
process, Ward's apparatus or seed point based clustering.
[0363] In some implementations, apparatus 4800 includes a temporal
bandpass filter 4804 that applies a frequency filter to the output
of the regional facial clusterial module 4608. The temporal
bandpass filter 4804 performs block 5412 in FIG. 54. In some
implementations, the temporal bandpass filter 4804 is a
one-dimensional spatial Fourier Transform, a high pass filter, a
low pass filter, a bandpass filter or a weighted bandpass filter.
Some implementations of temporal bandpass filter 4804 includes
de-noising (e.g. smoothing of the data with a Gaussian filter).
[0364] The forehead skin-pixel-identification module 4602, the
spatial bandpass filter 4802, the regional facial clusterial module
4608 and the temporal bandpass filter 4804 amplify temporal motion
in the two or more images 2854.
[0365] In some implementations, apparatus 4800 includes a
temporal-motion identifier 4612 that identifies temporal motion of
the output of the frequency-filter 4610. Thus, the temporal motion
represents temporal motion of the images 2854. The temporal-motion
identifier 4612 performs block 5306 in FIG. 53 or block 5412 in
FIG. 54.
[0366] In some implementations, apparatus 4800 includes a
biological vital-sign generator 4614 that generates one or more
biological vital sign(s) 4616 from the temporal motion. The
biological vital sign(s) 4616 are displayed for review by a
healthcare worker or stored in a volatile or nonvolatile memory for
later analysis, or transmitted to other devices for analysis.
[0367] FIG. 49 is a block diagram of an apparatus 4900 of motion
amplification, according to an implementation.
[0368] In some implementations, apparatus 4900 includes a
pixel-examiner 4902 that examines pixel-values of two or more
images 2854. The pixel-examiner 4902 performs block 5404 in FIG.
54.
[0369] In some implementations, apparatus 4900 includes a temporal
motion determiner 4906 that determines a temporal motion of
examined pixel-values. The temporal motion determiner 4906 performs
block 5408 in FIG. 54.
[0370] In some implementations, apparatus 4900 includes a
signal-processor 4908 that applies signal processing to the pixel
value temporal motion, generating an amplified-temporal-motion. The
signal processing amplifies the temporal motion, even when the
temporal motion is small In some implementations, the signal
processing performed by signal-processor 4908 is temporal bandpass
filtering that analyzes frequencies over time. In some
implementations, the signal processing performed by
signal-processor 4908 is spatial processing that removes noise.
Apparatus 4900 amplifies only small temporal motion in the
signal-processing module.
[0371] In some implementations, apparatus 4900 includes a
biological vital-sign generator 4614 that generates one or more
biological vital sign(s) 4616 from the temporal motion. The
biological vital sign(s) 4616 are displayed for review by a
healthcare worker or stored in a volatile or nonvolatile memory for
later analysis, or transmitted to other devices for analysis.
[0372] While apparatus 4900 can process large temporal motion, an
advantage in apparatus 4900 is provided for small temporal motion.
Therefore apparatus 4900 is most effective when the two or more
images 2854 have small temporal motion between the two or more
images 2854. In some implementations, a biological vital sign is
generated from the amplified-temporal-motion of the two or more
images 2854 from the signal-processor 4908.
[0373] FIG. 50 is a block diagram of an apparatus 5000 of motion
amplification, according to an implementation. Apparatus 5000
analyzes the temporal and spatial motion in digital images of an
animal subject in order to generate and communicate biological
vital signs.
[0374] In some implementations, apparatus 5000 includes a
forehead-skin pixel identification module 5002 that identifies
pixel-values 5006 that are representative of the skin in two or
more images 5004. The forehead-skin pixel identification module
5002 performs block 5404 in FIG. 54. Some implementations of the
forehead-skin pixel identification module 5002 perform an automatic
seed point based clustering process on the two images 5004.
[0375] In some implementations, apparatus 5000 includes a
frequency-filter module 5008 that receives the identified
pixel-values 5006 that are representative of the skin and applies a
frequency filter to the identified pixel-values 5006. The
frequency-filter module 5008 performs block 5406 in FIG. 54 to
process the images 2854 in the frequency domain. Each of the images
2854 is Fourier transformed, multiplied with a filter function and
then re-transformed into the spatial domain. Frequency filtering is
based on the Fourier Transform. The operator receives the images
2854 and a filter function in the Fourier domain The images 2854
are then multiplied with the filter function in a pixel-by-pixel
fashion using the formula:
G(k,l)=F(k,l)H(k,l)
[0376] where F(k,l) is the image of identified pixel-values 5006 in
the Fourier domain, H(k,l) the filter function and G(k,l) is the
frequency filtered identified pixel-values of skin 5010. To obtain
the resulting image in the spatial domain, G(k,l) is re-transformed
using the inverse Fourier Transform. In some implementations, the
frequency-filter module 5008 is a two-dimensional spatial Fourier
Transform, a high pass filter, a low pass filter, a bandpass filter
or a weighted bandpass filter.
[0377] In some implementations, apparatus 5000 includes a
spatial-cluster module 5012 that includes a spatial clusterer that
is applied to the frequency filtered identified pixel-values of
skin 5010, generating spatial clustered frequency filtered
identified pixel-values of skin 5014. The spatial-cluster module
5012 performs block 5408 in FIG. 54. In some implementations the
spatial-cluster module 5012 includes fuzzy clustering, k-means
clustering, expectation-maximization process, Ward's apparatus or
seed point based clustering.
[0378] In some implementations, apparatus 5000 includes a
frequency-filter module 5016 that applies a frequency filter to the
spatial clustered frequency filtered identified pixel-values of
skin 5014, which generates frequency filtered spatial clustered
frequency filtered identified pixel-values of skin 5018. The
frequency-filter module 5016 performs block 5410 in FIG. 54. In
some implementations, the frequency-filter module 5016 is a
one-dimensional spatial Fourier Transform, a high pass filter, a
low pass filter, a bandpass filter or a weighted bandpass filter.
Some implementations of frequency-filter module 5016 includes
de-noising (e.g. smoothing of the data with a Gaussian filter).
[0379] The forehead-skin pixel identification module 5002, the
frequency-filter module 5008, the spatial-cluster module 5012 and
the frequency-filter module 5016 amplify temporal motion in the two
or more images 2854.
[0380] In some implementations, apparatus 5000 includes a
temporal-motion module 5020 that determines temporal motion 5022 of
the frequency filtered spatial clustered frequency filtered
identified pixel-values of skin 5018. Thus, temporal motion 5022
represents temporal motion of the images 2854. The temporal-motion
module 5020 performs block 5412 in FIG. 54.
[0381] FIG. 51 is a block diagram of an apparatus 5100 of motion
amplification, according to an implementation. Apparatus 5100
analyzes the temporal and spatial motion in digital images of an
animal subject in order to generate and communicate biological
vital signs.
[0382] In some implementations, apparatus 5100 includes a
forehead-skin pixel identification module 5002 that identifies
pixel-values 5006 that are representative of the skin in two or
more images 2854. The forehead-skin pixel identification module
5002 performs block 5404 in FIG. 54. Some implementations of the
forehead-skin pixel identification module 5002 perform an automatic
seed point based clustering process on the images 2854.
[0383] In some implementations, apparatus 5100 includes a
frequency-filter module 5008 that receives the identified
pixel-values 5006 that are representative of the skin and applies a
frequency filter to the identified pixel-values 5006. The
frequency-filter module 5008 performs block 5406 in FIG. 54 to
process the images 2854 in the frequency domain. Each of the images
2854 is Fourier transformed, multiplied with a filter function and
then re-transformed into the spatial domain. Frequency filtering is
based on the Fourier Transform. The apparatus 5100 takes the images
2854 and a filter function in the Fourier domain. The images 2854
are then multiplied with the filter function in a pixel-by-pixel
fashion using the formula:
G(k,l)=F(k,l)H(k,l)
[0384] where F(k,l) is each of the images 2854 of identified
pixel-values 5006 in the Fourier domain, H(k,l) the filter function
and G(k,l) is the frequency filtered identified pixel-values of
skin 5010. To obtain the resulting image in the spatial domain,
G(k,l) is re-transformed using the inverse Fourier Transform. In
some implementations, the frequency-filter module 5008 is a
two-dimensional spatial Fourier Transform, a high pass filter, a
low pass filter, a bandpass filter or a weighted bandpass
filter.
[0385] In some implementations, apparatus 5100 includes a
spatial-cluster module 5012 that includes a spatial clusterer that
is applied to the frequency filtered identified pixel-values of
skin 5010, generating spatial clustered frequency filtered
identified pixel-values of skin 5014. The spatial-cluster module
5012 performs block 5408 in FIG. 54. In some implementations the
spatial clustering includes fuzzy clustering, k-means clustering,
expectation-maximization process, Ward's apparatus or seed point
based clustering.
[0386] In some implementations, apparatus 5100 includes a
frequency-filter module 5016 that applies a frequency filter to the
spatial clustered frequency filtered identified pixel-values of
skin 5014, which generates frequency filtered spatial clustered
frequency filtered identified pixel-values of skin 5018. The
frequency-filter module 5016 performs block 54108 in FIG. 54 to
generate a temporal motion 5022. In some implementations, the
frequency-filter module 5016 is a one-dimensional spatial Fourier
Transform, a high pass filter, a low pass filter, a bandpass filter
or a weighted bandpass filter. Some implementations of the
frequency-filter module 5016 includes de-noising (e.g. smoothing of
the data with a Gaussian filter). The forehead-skin pixel
identification module 5002, the frequency-filter module 5008, the
spatial-cluster module 5012 and the frequency-filter module 5016
amplify temporal motion in the two or more images 2854.
[0387] The frequency-filter module 5016 is operably coupled to one
or more modules in FIG. 52 to generate and present any one or a
number of biological vital signs from amplified motion in the
temporal motion 5022.
[0388] FIG. 52 is a block diagram of an apparatus 5200 of motion
amplification, according to an implementation. Apparatus 5200
analyzes the temporal and spatial motion in digital images of an
animal subject in order to generate and communicate biological
vital signs.
[0389] In some implementations, apparatus 5200 includes a
forehead-skin pixel identification module 5002 that identifies
pixel-values 5006 that are representative of the skin in two or
more images 2854. The forehead-skin pixel identification module
5002 performs block 5404 in FIG. 28. Some implementations of the
forehead-skin pixel identification module 5002 perform an automatic
seed point based clustering process on the images 2854. In some
implementations, apparatus 5200 includes a spatial bandpass filter
module 5202 that applies a spatial bandpass filter to the
identified pixel-values 5006, generating spatial bandpassed
filtered identified pixel-values of skin 5204. In some
implementations, the spatial bandpass filter module 5202 includes a
two-dimensional spatial Fourier Transform, a high pass filter, a
low pass filter, a bandpass filter or a weighted bandpass
filter.
[0390] In some implementations, apparatus 5200 includes a
spatial-cluster module 5012 that includes a spatial clusterer that
is applied to the frequency filtered identified pixel-values of
skin 5010, generating spatial clustered spatial bandpassed
identified pixel-values of skin 5206. In some implementations the
spatial clustering includes fuzzy clustering, k-means clustering,
expectation-maximization process, Ward's apparatus or seed point
based clustering.
[0391] In some implementations, apparatus 5200 includes a temporal
bandpass filter module 5208 that applies a temporal bandpass filter
to the spatial clustered spatial bandpass filtered identified
pixel-values of skin 5206, generating temporal bandpass filtered
spatial clustered spatial bandpass filtered identified pixel-values
of skin 5210. In some implementations, the temporal bandpass filter
is a one-dimensional spatial Fourier Transform, a high pass filter,
a low pass filter, a bandpass filter or a weighted bandpass
filter.
[0392] In some implementations, apparatus 5200 includes a
temporal-motion module 5020 that determines temporal motion 5322 of
the temporal bandpass filtered spatial clustered spatial bandpass
filtered identified pixel-values of skin 5210. Thus, temporal
motion 5322 represents temporal motion of the images 2854. The
temporal-motion module 5020 is operably coupled to one or more
modules in FIG. 52 to generate and present any one of a number of
biological vital signs from amplified motion in the temporal motion
5322.
[0393] FIG. 53 is a block diagram of an apparatus 5300 of motion
amplification, according to an implementation.
[0394] In some implementations, apparatus 5300 includes a
pixel-examination-module 5302 that examines pixel-values of two or
more images 2854, generating examined pixel-values 5304. In some
implementations, the pixel-examination-module 5302 performs block
5406 in FIG. 54.
[0395] In some implementations, apparatus 5300 includes a temporal
motion determiner module 5306 that determines a temporal motion
5308 of the examined pixel-values 5304. In some implementations,
the temporal motion determiner module 5306 performs block 5406 in
FIG. 54.
[0396] In some implementations, apparatus 5300 includes a
signal-processing module 5310 that applies signal processing to
pixel values of the temporal motion 5308, generating an amplified
temporal motion 5322. In some implementations, the
signal-processing module 5310 performs block 5408 in FIG. 54. The
signal processing amplifies the temporal motion 5308, even when the
temporal motion 5308 is small In some implementations, the signal
processing performed by signal-processing module 5310 is temporal
bandpass filtering that analyzes frequencies over time. In some
implementations, the signal processing performed by
signal-processing module 5310 is spatial processing that removes
noise. Apparatus 5300 amplifies only small temporal motion in the
signal-processing module.
[0397] While apparatus 5300 can process large temporal motion, an
advantage in apparatus 5300 is provided for small temporal motion.
Therefore apparatus 5300 is most effective when the two or more
images 2854 have small temporal motion between the two or more
images 2854. In some implementations, a biological vital sign is
generated from the amplified-temporal-motion of the two or more
images 2854 from the signal-processing module 5310.
[0398] FIG. 54 is a flowchart of a method 5400 of motion
amplification from which to generate and communicate biological
vital signs, according to an implementation. FIG. 54 uses spatial
and temporal signal processing to generate biological vital signs
from a series of digital images.
[0399] Method 5400 analyzes the temporal and spatial motion in
digital images of an animal subject in order to generate and
communicate the biological vital signs.
[0400] In some implementations, method 5400 includes cropping
plurality of images to exclude areas that do not include a skin
region, at block 5402. For example, the excluded area can be a
perimeter area around the center of each image, so that an outside
border area of the image is excluded. In some implementations of
cropping out the border, about 72% of the width and about 72% of
the height of each image is cropped out, leaving only 7.8% of the
original uncropped image, which eliminates about 11/12 of each
image and reduces the amount of processing time for the remainder
of the actions in this process by about 12-fold. This one action
alone at block 5402 in method 5400 can reduce the processing time
of the plurality of images 2854 by 86%, which is of significant
difference to the health workers who used devices that implement
method 5400. In some implementations, the remaining area of the
image after cropping in a square area and in other implementation
the remaining area after cropping is a circular area. Depending
upon the topography and shape of the area in the images that has
the most pertinent portion of the imaged subject, different
geometries and sizes are most beneficial. In other implementations
of apparatus 4600, 4700, 4800, 4900, 5000, 5100, 5200 and 5300, a
cropper module that performs block 5402 is placed at the beginning
of the modules to greatly decrease processing time of the
apparatus.
[0401] In some implementations, method 5400 includes identifying
pixel-values of the plurality of or more cropped images that are
representative of the skin, at block 5404. Some implementations of
identifying pixel-values that are representative of the skin
include performing an automatic seed point based clustering process
on the least two images.
[0402] In some implementations, method 5400 includes applying a
spatial bandpass filter to the identified pixel-values, at block
5406. In some implementations, the spatial filter in block 5402 is
a two-dimensional spatial Fourier Transform, a high pass filter, a
low pass filter, a bandpass filter or a weighted bandpass
filter.
[0403] In some implementations, method 5400 includes applying
spatial clustering to the spatial bandpass filtered identified
pixel-values of skin, at block 5408. In some implementations the
spatial clustering includes fuzzy clustering, k-means clustering,
expectation-maximization process, Ward's method or seed point based
clustering.
[0404] In some implementations, method 5400 includes applying a
temporal bandpass filter to the spatial clustered spatial bandpass
filtered identified pixel-values of skin, at block 5410. In some
implementations, the temporal bandpass filter in block 5208 is a
one-dimensional spatial Fourier Transform, a high pass filter, a
low pass filter, a bandpass filter or a weighted bandpass
filter.
[0405] In some implementations, method 5400 includes determining
temporal motion of the temporal bandpass filtered spatial clustered
spatial bandpass filtered identified pixel-values of skin, at block
5412.
[0406] In some implementations, method 5400 includes analyzing the
temporal motion to generate and visually display a pattern of flow
of blood, at block 5414. In some implementations, the pattern flow
of blood is generated from motion changes in the pixels and the
temporal motion of color changes in the skin. In some
implementations, method 5400 includes displaying the pattern of
flow of blood for review by a healthcare worker, at block 5416.
[0407] In some implementations, method 5400 includes analyzing the
temporal motion to generate heartrate, at block 5418. In some
implementations, the heartrate is generated from the frequency
spectrum of the temporal motion in a frequency range for heart
beats, such as (0-10 Hertz). In some implementations, method 5400
includes displaying the heartrate for review by a healthcare
worker, at block 5420.
[0408] In some implementations, method 5400 includes analyzing the
temporal motion to determine respiratory rate, at block 5422. In
some implementations, the respiratory rate is generated from the
motion of the pixels in a frequency range for respiration (0-5
Hertz). In some implementations, method 5400 includes displaying
the respiratory rate for review by a healthcare worker, at block
5424.
[0409] In some implementations, method 5400 includes analyzing the
temporal motion to generate blood pressure, at block 5426. In some
implementations, the blood pressure is generated by analyzing the
motion of the pixels and the color changes based on the clustering
process and potentially temporal data from the infrared sensor. In
some implementations, method 5400 includes displaying the blood
pressure for review by a healthcare worker, at block 5428.
[0410] In some implementations, method 5400 includes analyzing the
temporal motion to generate EKG, at block 5430. In some
implementations, method 5400 includes displaying the EKG for review
by a healthcare worker, at block 5432.
[0411] In some implementations, method 5400 includes analyzing the
temporal motion to generate pulse oximetry, at block 5434. In some
implementations, the pulse oximetry is generated by analyzing the
temporal color changes based in conjunction with the k-means
clustering process and potentially temporal data from the infrared
sensor. In some implementations, method 5400 includes displaying
the pulse oximetry for review by a healthcare worker, at block
5434.
9. Apparatus of Interoperability Device Manager Components of an
EMR System
[0412] FIG. 55 is a block diagram of apparatus of an electronic
medical records (EMR) capture system 5500, according to an
implementation. EMR capture system 5500 supports the capture and
management of MVS data including blood glucose levels. EMR capture
system 5500 includes a device/user layer 5502 that further includes
one or more MVS device(s) 5504. Examples of the MVS devices(s) 5504
are shown in FIG. 1-37.
[0413] EMR capture system 5500 includes a middle layer 5506 that
communicates with the MVS apparatus 5504 in the device/user layer
5502. The middle layer 5506 includes user/patient vital sign
results data 5508 that is communicated via cellular communication
paths, such as 3G, 4G or a 5G or a Wi-Fi.RTM. communication path,
user/patient vital sign results data 5510 that is communicated via
a Wi-Fi.RTM. communication path and user/patient vital sign results
data 5512 that is communicated via a Bluetooth.RTM. communication
path. The middle layer 5506 further includes a first set of
application program interfaces 5514 and optionally a second set of
application program interfaces 5516 that the user/patient vital
sign results data 5508, 5510 and 5512 is communicated to and from
the MVS apparatus 5504 in the device/user layer 5502 between one or
more hubs 5518, bridges 5520, interface engines 5522 and gateways
5524 in the middle layer 5506. The middle layer 5506 further
includes an interoperability device manager component 5526 that
deploys data such as primary communication protocol, configuration
settings, firmware modifications and representations of an
authorized location to the MVS apparatus 5504 in the device/user
layer 5502. The interoperability device manager component 5526
sends the data via a 3G, 4G or 5G cellular communication path 5528,
a Wi-Fi.RTM. communication path 5530, a Bluetooth.RTM.
communication path 5532 and/or a near-field communication (NFC)
path 5534. The interoperability device manager component 5526
receives the device health data via 3G, 4G or 5G cellular
communication path 5536 or a Wi-Fi.RTM. communication path 5538
from the MVS apparatus 5504 in the device/user layer 5502. Examples
of MVS apparatus 5504 include the MVS finger cuffs in FIG. 1-11,
MVS finger cuff accessories in FIG. 12-20, MVS finger clips in FIG.
21-27, MVS smartphones in FIG. 28-29, MVS smartphone systems, MVS
finger cuff accessories and MVS smartphones in FIGS. 30-34 and the
MVS devices in FIG. 35-37. The user/patient vital sign results data
5508, 5510 and 5512 can include patient records 4412.
[0414] The one or more hubs 5518, bridges 5520, interface engines
5522 and gateways 5524 in the middle layer 5506 communicate via 3G,
4G or 5G cellular communication path 5540 and/or an
internet/intranet communication path 5542 to an EMR/clinical data
repository 5544. The EMR/clinical data repository 5544 includes an
EMR system 5546, a clinical monitoring system 5552 and/or a
clinical data repository 5554. The EMR system 5546 is located
within or controlled by a hospital facility. One example of
Bluetooth.RTM. protocol is Bluetooth.RTM. Core Specification
Version 2.1 published by the Bluetooth.RTM. SIG, Inc. Headquarters,
5209 Lake Washington Blvd NE, Suite 350, Kirkland, Wash. 98033. In
other implementations, Zigbee.RTM. or Z-Wave.RTM. can be used
instead of Bluetooth.RTM..
[0415] FIG. 56 is a block diagram of a system of interoperability
device manager component 5526, according to an implementation. The
interoperability device manager component 5526 includes a device
manager 5602 that connects one or more MVS apparatus 5504 and
middleware 5606. The MVS apparatus 5504 are connected to the device
manager 5602 through via a plurality of services, such as a chart
service 5608, an observation service 5610, a patient service 5612,
a user service and/or an authentication service 5616 to a bridge
5618 in the interoperability device manager 5602. The MVS apparatus
5504 are connected to the device manager 5602 to a plurality of
maintenance function components 5620, such as push firmware 5622, a
push configuration component 5624 and/or a keepalive signal
component 5626. The keepalive signal component 5626 is coupled to
the middleware 5606. In some implementations, the APIs 5630, 5632,
5634 and 5636 are health date APIs, observation APIs, electronic
health record (EHR) or electronic medical record (EMR) APIs.
[0416] The bridge 5618 is operably coupled to a greeter component
5628. The greeter component 5628 synchronizes date/time of the
interoperability device manager 5602, checks device log, checks
device firmware, checks device configuration and performs
additional security. The greeter component 5628 is coupled to the
keepalive signal component 5626 through a chart application program
interface component 5630, a patient application program interface
component 5632, a personnel application program interface component
5634 and/or and authentication application program interface
component 5636. All charted observations from the chart application
program interface component 5630 are stored in a diagnostics log
5638 of a datastore 5640. The datastore 5640 also includes
interoperability device manager settings 5642 for the application
program interface components 5630, 5632, 5634 and/or 5636, current
device configuration settings 5644, current device firmware 5646
and a device log 5648.
[0417] The interoperability device manager 5602 also includes a
provision device component 5650 that provides network/Wi-Fi.RTM.
Access, date/time stamps, encryption keys--once for each of the MVS
apparatus 5504 for which each MVS apparatus 5504 is registered and
marked as `active` in the device log 5648. The provision device
component 5650 activates each new MVS apparatus 5504 on the
interoperability device manager component 5526 through a device
activator 5652.
[0418] FIG. 57 is a block diagram of apparatus of an EMR capture
system 5700, according to an implementation in which an
interoperability manager component manages all communications in
the middle layer. In EMR capture system 5700, an interoperability
manager component 5702 manages all communications in the middle
layer 5506 between the device/user layer 5502 and the first set of
application program interfaces 5514, the optional second set of
application program interfaces 5516, one or more hubs 5518, bridges
5520, interface engines 5522 and gateways 5524 in the middle layer
5506. In EMR capture system 5700, the operation of the device/user
layer 5502 and the EMR/clinical data repository 5544 is the same as
in the EMR capture system 5500.
[0419] Some other implementations of an electronic medical records
capture system includes a bridge that transfers patient record 4412
from MVS apparatus 5504 to EMR systems in hospital and clinical
environments. Each patient record 4412 includes patient measurement
data, such as biological vital sign 3536 in FIG. 35-40, blood
glucose level 6502 in FIG. 65, biological vital sign 3536 in FIGS.
35-40 and biological vital sign 4616 in FIG. 46-61. Examples MVS
apparatus 5504 include the MVS smartphone system in FIG. 30, the
MVS smartphone systems in FIG. 30-34, the apparatus of motion
amplification in FIGS. 46-54 and the MVS smartphone 2800. In some
implementations, the MVS apparatus 5504 includes a temperature
estimation table that is stored in memory. The temperature
estimation table is a lookup table that correlates a sensed
forehead temperature to a body core temperature. The correlation of
sensed forehead temperature to body core temperature is a
significant advance in the technology of the MVS smartphone systems
in FIG. 30-34, the apparatus of motion amplification in FIGS. 46-54
and the MVS smartphone 2800 in FIG. 28, because the correlation has
been developed to a highly accurate degree, to an extent of
accuracy that surpasses all other MVS smartphone systems, apparatus
that estimates a body core temperature, apparatus of motion
amplification, hand-held devices, MVS smartphone systems and
tablets, that for the first time provides sufficient accuracy to be
used in medical clinics. The EMR data capture system includes two
important aspects: 1. A server bridge to control the flow of
patient measurement data from MVS apparatus 5504 to one or more and
to manage local MVS apparatus 5504. 2. The transfer of patient
measurement data in a patient record 4412, anonymous, and other
patient status information to a cloud based EMR/clinical data
repository 5544. The bridge controls and manages the flow of
patient measurement data to an EMR/clinical data repository 5544
and another EMR/clinical data repository 5544 and provides
management services to MVS apparatus 5504. The bridge provides an
interface to: a wide range of proprietary EMR/clinical data
repository 5544, location specific services, per hospital, for
verification of active operator, and if necessary, patient
identifications, and a cloud based EMR/clinical data repository
5544) of one or more MVS apparatus 5504, for the purpose of storing
all measurement records in an anonymous manner for analysis. A
setup, management and reporting mechanism also provided. The bridge
accepts communications from MVS apparatus 5504 to: Data format
conversion and transferring patient measurement records to
EMR/clinical data repository 5544, manage the firmware and
configuration settings of the MVS apparatus 5504, determine current
health and status of the MVS apparatus 5504, support device level
protocol for communications, TCP/IP. The support device level
protocol supports the following core features: authentication of
connected device and bridge transfer of patient measurement records
to bridge with acknowledgement and acceptance by the bridge or EMR
acceptance, support for dynamic update of configuration information
and recovery of health and status of the MVS apparatus 5504,
support for firmware update mechanism of firmware MVS apparatus
5504. The EMR data capture system provides high availability,
24/7/365, with 99.99% availability. The EMR data capture system
provides a scalable server system to meet operational demands in
hospital operational environments for one or both of the following
deployable cases: 1) A local network at an operational site in
which the bridge provides all features and functions in a defined
operational network to manage a system of up to 10,000+MVS
apparatus 5504. 2) Remote or cloud based EMR/clinical data
repository 5544 in which the bridge provides all services to many
individual hospital or clinical sites spread over a wide
geographical area, for 1,000,000+MVS apparatus 5504. The bridge
provides a central management system for the MVS apparatus 5504
that provides at least the following functions: 1) configuration
management and update of the MVS apparatus 5504 2) device level
firmware for all of the MVS apparatus 5504 and 3) management and
reporting methods for the MVS apparatus 5504. The management and
reporting methods for the MVS apparatus 5504 provides (but not
limited to) health and status of the MVS apparatus 5504, battery
level, replacement warning of the MVS apparatus 5504,
check/calibration nearing warning of the MVS apparatus 5504,
rechecking due to rough handling or out of calibration period of
the MVS apparatus 5504, history of use, number of measurements,
frequency of use etc. of the MVS apparatus 5504, display of current
device configuration of the MVS apparatus 5504, Date/time of last
device communications with each of the MVS apparatus 5504. The
bridge provides extendable features, via software updates, to allow
for the addition of enhanced features without the need for
additional hardware component installation at the installation
site. The bridge provides a device level commission mechanism and
interface for the initial setup, configuration and test MVS
apparatus 5504 on the network. The bridge supports MVS smartphone
systems that are not hand-held. Coverage of the EMR data capture
system in a hospital can include various locations, wards, ER
rooms, offices, physician's Offices etc. or anywhere where
automatic management of patient biological vital sign information
is required to be saved to a remote EMR system. The MVS apparatus
5504 can communicate with a third party bridge to provide access to
data storage services, EMR systems, MVS smartphone system cloud
storage system etc. Networking setup, configuration, performance
characteristics etc. are also determined and carried out by the
third party bridge or another third party, for the operational
environments. The MVS smartphone system can support the network
protocols for communication with the third party bridge devices. In
some implementations the bridge is a remote cloud based bridge. The
remote cloud based bridge and the EMR/clinical data repositories
5544 are operably coupled to the network via the Internet.
[0420] In some implementations, a push data model is supported by
the EMR data capture system between the MVS apparatus 5504 and the
bridge in which connection and data are initially pushed from the
MVS apparatus 5504 to the bridge. Once a connection has been
established and the MVS apparatus 5504 and the bridge, such as an
authenticated communication channel, then the roles may be reversed
where the bridge controls the flow of information between the MVS
apparatus 5504 and the EMR/clinical data repository 5544. In some
implementations, the MVS apparatus 5504 are connected via a
wireless communication path, such as a Wi-H.RTM. connection to
Wi-H.RTM. access point(s). In other implementations, the MVS
apparatus 5504 are connected to a docking station via a wireless or
physical wired connection, such as local Wi-H.RTM., Bluetooth.RTM.,
Bluetooth.RTM. Low Energy (BLE), serial, USB, etc., in which case
the docking station then acts as a local pass-through connection
and connects to the bridge via a LAN interface and/or cellular or
Wi-H.RTM. link from the docking station to the bridge. In some
implementations, the MVS apparatus 5504 are connected via a 3G, 4G
or a 5G cellular data communication path to a cellular
communication tower which is operably coupled to a cell service
provider's cell network which is operably coupled to a
bridge/access point/transfer to a LAN or WLAN. In some
implementations one or more MVS apparatus 5504 are connected a
smartphone via a communication path such as a Bluetooth.RTM.
communication path, a 3G, 4G or a 5G cellular data communication
path, a USB communication path, a Wi-H.RTM. communication path, or
a Wi-H.RTM. direct communication path to the cell phone; and the
smartphone is connected to a cellular communication tower via a 3G,
4G or a 5G cellular data communication path. These portable MVS
apparatus 5504 support various power saving modes and as such each
device is responsible for the initiation of a connection to the
wireless network or a wired network and the subsequent connection
to the bridge that meets their own specific operational
requirements, which provides the MVS apparatus 5504 additional
control over their own power management usage and lifetime. In some
implementations in which the MVS apparatus 5504 attempt connection
to the bridge, the bridge is allocated a static Internet protocol
(IP) address to reduce the IP discovery burden on the MVS apparatus
5504 and thus connect the MVS smartphone system to the bridge more
quickly. More specifically, the MVS apparatus 5504 are not required
to support specific discovery protocols or domain name service
(DNS) in order to determine the IP address of the bridge. It is
therefore important in some implementations that the bridge IP
address is static and does not change over the operational lifetime
of EMR data capture system on the network. In other
implementations, a propriety network discovery protocol using UDP
or TCP communications methods is implemented. In other
implementations, the MVS apparatus 5504 have a HTTP address of a
remote sever that acts as a discovery node for the MVS apparatus
5504 to obtain a connection to a remote system or to obtain that
remote systems network address. In some implementations
installation of a new MVS apparatus 5504 on the network requires
configuration of the MVS apparatus 5504 for the bridge of IP
address and other essential network configuration and security
information. Commissioning of a MVS apparatus 5504 on the network
in some implementations is carried out from a management interface
on the bridge. In this way a single management tool can be used
over all lifecycle phases of a MVS apparatus 5504 on the network,
such as deployment, operational and decommissioning. In some
implementations the initial network configuration of the MVS
apparatus 5504 does not require the MVS apparatus 5504 to support
any automated network level configuration protocols, WPS, Zeroconfi
etc. Rather the bridge supports a dual network configuration, one
for operational use on the operational network of the hospital or
clinic, or other location, and an isolated local network, with
local DHCP server, for out of the box commissioning of a new MVS
apparatus 5504 and for diagnostic test of the MVS apparatus 5504.
MVS apparatus 5504 can be factory configured for known network
settings and contain a default server IP address on the
commissioning network. In addition the MVS apparatus 5504 are
required in some implementations to support a protocol based
command to reset the MVS apparatus 5504 to network factory defaults
for test purposes. In some situations, the firmware revision(s) of
the MVS apparatus 5504 are not consistent between all of the MVS
apparatus 5504 in the operational environment. Therefore the bridge
is backwards compatible with all released firmware revisions from
firmware and protocol revision, data content and device settings
view point of the MVS apparatus 5504. As a result, different
revision levels MVS apparatus 5504 can be supported at the same
time on the network by the bridge for all operations.
Implementation Alternatives
Operational Features and Implementation Capability
[0421] Some implementations of the EMR data capture systems 5500
and 5700 have limited operational features and implementation
capability. A significant function of the EMR data capture systems
5500 and 5700 with the limited operational features and
implementation capability in the bridge 5520 is to accept data from
a MVS apparatus 5504 and update the EMR/Clinical Data Repository
5544. The EMR/Clinical Data Repository 5544 can be one or more of
the following: Electronic Medical Records System (EMR) 5546,
Clinical Monitoring System 5552 and/or Clinical Data Repository
5554.
[0422] The following limited feature set in some implementations is
supported by the EMR data capture systems 5500 and 5700 for the
demonstrations:
[0423] Implementation to a local IT network on a server of the
local IT network, OR located on a remote-hosted network, whichever
meets the operational requirements for healthcare system.
[0424] Acceptance of patient medical records from a MVS apparatus
5504:
[0425] a. Date and Time
[0426] b. Operator identification
[0427] c. Patient identification
[0428] d. Vital Sign measurement(s)
[0429] e. Device manufacturer, model number and firmware
revision
[0430] Acceptance of limited status information from a MVS
apparatus 5504:
[0431] a. Battery Level
[0432] b. Hospital reference
[0433] c. location reference
[0434] d. Manufacturer identification, serial number and firmware
revision
[0435] e. Unique identification number
[0436] Transfer of patient records from a MVS apparatus 5504 to a
third party EMR capture system and to the EMR data capture systems
5500 and 5700, respectively in that order.
[0437] User interface for status review of known MVS apparatus
5504.
[0438] Configuration update control for active devices providing
configuration of:
[0439] a. Hospital reference
[0440] b. Unit location reference
Limited Operational Features and Implementation Capability
[0441] The following features are supported limited operational
capability:
[0442] A Patient Record Information and measurement display
interface for use without submission of that data to an
EMR/Clinical Data Repository 5544.
[0443] Update of device firmware to support and activate
determination of blood glucose levels over the wireless network. In
some implementations, components for determination of blood glucose
levels (or other vital signs) is in the firmware or other
nonvolatile memory, but the components are not active or activated
as indicated by a flag in flash memory of the device. Subsequently,
action is taken to activate the components by changing the flag in
the flash memory.
Operational Use
Local Network Based--Single Client
[0444] In some implementations, the MVS apparatus 5504 are deployed
to a local hospital, or other location, wireless IT network that
supports Wi-Fi.RTM. enabled devices. The MVS apparatus 5504
supports all local network policy's including any local security
policy/protocols, such as WEP, WPA, WPA2, WPA-EPA as part of the
connection process for joining the network. In some
implementations, the MVS apparatus 5504 operates on both physical
and virtual wireless LAN's, WAN's, and the MVS apparatus 5504 are
configured for operation on a specific segment of the network.
Depending on the IT network structure, when the MVS apparatus 5504
is configured for operation on a specific segment of the network,
the MVS apparatus 5504 network connection ability is limited to the
areas of the operational environment for which it as be configured.
Therefore, the MVS apparatus 5504 in network environments that have
different network configurations are configured to ensure that when
the MVS apparatus 5504 are used in various locations throughout the
environment that the MVS apparatus 5504 has access in all required
areas.
[0445] In some implementations the bridge 5520 system is located on
the same IT network and deployed in accordance with all local IT
requirements and policy's and that the MVS apparatus 5504 on this
network are able to determine a routable path to the bridge 5520.
The MVS apparatus 5504 and the server are not required to implement
any network name discovery protocols and therefore the bridge 5520
is required to be allocated static IP address on the network. In
the case where a secondary bridge device is deployed to the network
as a backup for the primary, or the bridge 5520 supports a dual
networking interface capability, then the secondary bridge IP
address is also required to be allocated a static IP address. It is
important to note that this is a single organization implementation
and as such the bridge 5520 is configured to meet the security and
access requirements of a single organization.
[0446] An implementation of a remote cloud-based bridge 5520 for a
single client is similar to the local network case described at the
end of the description of FIG. 13, with the exception that the
bridge 5520 may not be physically located at the physical site of
the MVS apparatus 5504.
[0447] The MVS apparatus 5504 include a temperature estimation
table (not shown in FIG. 13). The temperature estimation table is
stored in memory. The temperature estimation table is a lookup
table that correlates a sensed surface temperature to a body core
temperature.
[0448] The physical locale of the bridge 5520 is transparent to the
MVS apparatus 5504.
Remote Based--Multiple Client Support
[0449] In some implementations for smaller organizations or for
organizations that do not have a supporting IT infrastructure or
capability that a remote bridge 5520 system is deployed to support
more than one organization. Where the bridge 5520 is deployed to
support more than one organization, the bridge 5520 can be hosted
as a cloud based system. In this case the MVS apparatus 5504 are
located at the operational site for the supported different
geographical location organizations and tied to the bridge 5520 via
standard networking methods via either private or public
infrastructure, or a combination thereof.
[0450] Where a remote, i.e. non-local IT network, system is
deployed to support more than one hospital or other organization
EMR data capture systems 5500 and 5700 includes components that
isolate each of the supported organizations security and user
access policy's and methods along with isolating all data transfers
and supporting each organizations data privacy requirements. In
addition system performance is required to be balanced evenly
across all organizations. In this case each organization can
require their specific EMR data capture systems 5500 and 5700 be
used and their EMR data capture systems 5500 and 5700 are
concurrently operational with many diverse EMR/Clinical Repository
systems such as Electronic Medical Record System EMR 5546, 2,
Clinical Monitoring System 5552 and/or Clinical Data Repository
5554.
Single Measurement Update
[0451] The primary function of the MVS apparatus 5504 is to take
vital sign measurements, for example, blood glucose level, display
the result to the operator and to save the patient information and
the blood glucose level to an EMR/Clinical Data Repository 5544.
Normally the MVS apparatus 5504 are in a low power state waiting
for an operator to activate the unit for a patient measurement.
Once activated by the operator EMR data capture systems 5500 and
5700 will power up and under normal operating conditions guide the
operator through the process of blood glucose level measurement and
transmission of the patient record to the bridge 5520 for saving
using the EMR data capture systems 5500 and 5700.
[0452] Confirmation at each stage of the process by the operator is
required, to ensure a valid and identified patient result is
obtained and saved to the EMR, the key last confirmation point is:
Saving of data to the bridge 5520.
[0453] In some implementations, the confirmation at each stage in
some implementations is provided by the operator through either the
bridge 5520, multi-vital sign capture system(s) 5504, or the
EMR/Clinical Data Repository 5544.
[0454] When confirmation is provided by the bridge 5520 it is an
acknowledgment to the MVS apparatus 5504 that the bridge 5520 has
accepted the information for transfer to the EMR/Clinical Data
Repository 5544 in a timely manner and is now responsible for the
correct management and transfer of that data.
[0455] When confirmation is provided by the EMR, the bridge 5520 is
one of the mechanisms via which the confirmation is returned to the
MVS apparatus 5504. That is the MVS apparatus 5504 sends the data
to the bridge 5520 and then waits for the bridge 5520 to send the
data to the EMR and for the EMR to respond to the bridge 5520 and
then the bridge 5520 to the MVS apparatus 5504,
[0456] In some implementations depending on the operational network
and where the bridge 5520 is physically located, i.e. local or
remote, that the type of confirmation is configurable.
[0457] In some implementations, the MVS apparatus 5504 maintains an
internal non-volatile storage mechanism for unsaved patient records
if any or all of these conditions occur: The MVS apparatus 5504
cannot join the network. The MVS apparatus 5504 cannot communicate
with the bridge 5520. The MVS apparatus 5504 does not receive level
confirmation from either the bridge 5520 or the EMR/Clinical Data
Repository 5544. The MVS apparatus 5504 must maintain the internal
non-volatile storage mechanism in order to fulfill its primary
technical purpose in case of possible operational issues. When the
MVS apparatus 5504 has saved records present in internal memory of
the MVS apparatus 5504, then the MVS apparatus 5504 attempts to
transfer the saved records to the bridge 5520 for processing in a
timely automatic manner
Periodic Connectivity
[0458] The MVS apparatus 5504 in order to obtain date/time,
configuration setting, provides status information to the bridge
5520, transfers saved patient records and checks for a firmware
update to provide a mechanism on a configured interval
automatically that powers up and communicates to the configured
bridge 5520 without operator intervention.
[0459] Accordingly, outside of the normal clinical use activation
for the MVS apparatus 5504, the MVS apparatus 5504 can both update
its internal settings, and provide status information to the bridge
5520 system.
Automatic Transfer of Saved Patient Measurement Records (PMRs)
[0460] If the MVS apparatus 5504 for an unknown reason has been
unable to either join the network or connect to the bridge 5520 or
receive a bridge 5520 or EMR data level acknowledge that data has
been saved the MVS apparatus 5504 allows the primary clinical body
core temperature measurement function to be performed and saves the
resultant PMR in non-volatile internal memory up to a supported,
configured, maximum number of saved patient records on the MVS
apparatus 5504.
[0461] When the MVS apparatus 5504 are started for a measurement
action the MVS apparatus 5504 determines if the MVS apparatus 5504
contains any saved patient records in its internal memory. If one
or more saved patient records are detected then the MVS apparatus
5504 attempts to join the network immediately, connect to the
bridge 5520 and send the patient records one at a time to the
bridge 5520 device while waiting for the required confirmation that
the bridge 5520 has accepted the patient record. Note in this case
confirmation from the EMR is not required. On receipt of the
required validation response from the remote system the MVS
apparatus 5504 deletes the patient record from its internal memory.
Any saved patient record that is not confirmed as being accepted by
the remote device is maintained in the MVS apparatus 5504 internal
memory for a transfer attempt on the next power up of the MVS
apparatus 5504.
[0462] The MVS apparatus 5504 on a configured interval will also
carry out this function. In some implementations the MVS apparatus
5504 reduces the interval when saved patient records are present on
the MVS apparatus 5504 in order to ensure that the records are
transferred to the bridge 5520, and subsequently the EMR/Clinical
Data Repository 5544, in a timely manner once the issue has been
resolved. When this transfer mechanism is active status information
is presented to the operator on the MVS apparatus 5504 screen.
[0463] Under this operation it is possible for the bridge 5520
device to receive from a single MVS apparatus 5504 multiple patient
record transfer requests in rapid sequence.
Device Configuration
[0464] The MVS apparatus 5504 upon 1) connection to the bridge
5520, 2) configured interval or 3) operator initiation, transmits
to the bridge 5520 with the model number and all appropriate
revisions numbers and unique identification of the MVS apparatus
5504 to allow the bridge 5520 to determine the MVS apparatus 5504
capabilities and specific configurations for that MVS apparatus
5504.
[0465] The bridge 5520 acts as the central repository for device
configuration, either for a single device, a group of defined
devices or an entire model range in which the MVS apparatus 5504
queries the bridge 5520 for the device vital-signs of the MVS
apparatus 5504 and if the queried device vital-signs are different
from the MVS apparatus 5504, the MVS apparatus 5504 updates the
current setting to the new setting values as provided by the bridge
5520.
Device Status Management
[0466] In some implementations the bridge 5520 provides a level of
device management for the MVS apparatus 5504 being used with EMR
data capture systems 5500 and 5700. In some implementations, the
bridge 5520 is able to report and determine at least the
following:
[0467] Group and sort devices by manufacture, device model,
revisions information and display devices serial numbers, unique
device identification, asset number, revisions, etc. and any other
localized identification information configured into the MVS
apparatus 5504, e.g. ward location reference or Hospital
reference.
[0468] The last time a specific unit connected to EMR data capture
systems 5500 and 5700.
[0469] The current status of the given device, battery level, last
error, last date of re-calibration of check, or any other health
indicator supported by the MVS apparatus 5504.
[0470] Report devices out of their calibration period, or
approaching their calibration check.
[0471] Report devices that require their internal battery
replaced.
[0472] Report devices that require re-checking due to a detected
device failure or error condition, or that have been treated in a
harsh manner or dropped.
[0473] Determine if a MVS apparatus 5504 has not connected for a
period of time and identify the MVS apparatus 5504 as lost or
stolen. If the MVS apparatus 5504 reconnects to the network after
this period of time then the MVS apparatus 5504 in some
implementations is highlighted as requiring an accuracy check to
ensure that it is operational. In some implementations, the MVS
apparatus 5504 also supports this capability and after a
pre-determined time disconnects from the network to inhibit the
measurement function of the MVS apparatus 5504 until a MVS
apparatus 5504 level recheck is carried out.
[0474] Provide a mechanism to commission and decommission devices
onto and off of the network. If a MVS apparatus 5504 has not been
specifically commissioned for operation on the network then it in
some implementations is not be allowed to access the core services
supported by the bridge 5520 even if it has configured for
operation on the EMR data capture systems 5500 and 5700.
Firmware Update
[0475] In some implementations a firmware update for a given device
model is scheduled on the network as opposed to simply occurring.
When a MVS apparatus 5504 is activated for a patient measurement
firmware, updates are blocked because the update process delays the
patient biological vital sign measurement. Instead the bridge 5520
system includes a firmware update roll out mechanism where the date
and time of the update can be scheduled and the number of devices
being updated concurrently can be controlled.
[0476] In some implementations, when a MVS apparatus 5504 connects
to the bridge 5520 due to a heartbeat event that the MVS apparatus
5504 queries the bridge 5520 to determine if a firmware update for
that model of device is available and verify if the firmware MVS
apparatus 5504 (via revision number), is required to be updated.
The bridge 5520 responds to the query by the MVS apparatus 5504
based on whether or not a firmware update is available and the
defined schedule for the update process. If an update is available
at the bridge 5520 but the current time and date is not valid for
the schedule then the bridge 5520 transmits a message to the MVS
apparatus 5504 that there is an update but that the update process
is delayed and update the MVS apparatus 5504 firmware check
interval configuration. The firmware check interval setting will
then be used by the MVS apparatus 5504 to reconnect to the bridge
5520 on a faster interval than the heartbeat interval in order to
facilitate a more rapid update. For e.g. the firmware update
schedule on the bridge 5520 in some implementations is set to every
night between 2 am and 4 am and the interval timer in some
implementations is set to for example, every 15 minutes.
[0477] In some implementations the bridge 5520 manages the firmware
update process for many different MVS smartphone systems 5504 each
with their specific update procedure, activated vital sign
determination processes, file formats, and verification methods and
from a date and time scheduling mechanism and the number of devices
being update concurrently. In addition in some implementations the
bridge 5520 will provide a mechanism to manage and validate the
firmware update files maintained on the bridge 5520 for use with
the MVS apparatus 5504.
[0478] This section concludes with short notes below on a number of
different aspects of the EMR data capture systems 5500 and 5700
follow on numerous topics:
[0479] Remote--single client operation: The bridge 5520
architecture provide remote operation on a hospital network system.
Remote operation is seen as external to the network infrastructure
that the MVS apparatus 5504 are operational on but considered to be
still on the organizations network architecture. This can be the
case where a multiple hospital--single organization group has
deployed EMR data capture systems 5500 and 5700 but one bridge 5520
device services all hospital locations and the bridge 5520 is
located at one of the hospital sites or their IT center.
[0480] Remote--multiple client operation: The bridge 5520
architecture in some implementations is limited to remote operation
on a cloud based server that supports full functionality for more
than one individual separate client concurrently when a cloud based
single or multiple server system is deployed to service one or more
individual hospital/clinical organizations.
[0481] Multiple concurrent EMR support: For a single remote bridge
5520 servicing multiple clients EMR data capture systems 5500 and
5700 supports connectivity to an independent EMR, and a different
EMR vendor, concurrently for each supported client. With one bridge
5520 servicing multiple clients in some implementations, each
client requires the configuration to send data securely to
different EMR/Clinical Data Repositories.
[0482] Support Different EMR for same client: The bridge 5520
architecture for operation in a single client organization supports
the user by the organization of different EMR/Clinical Data
Repository 5544 from different departments of wards in the
operational environment. It is not uncommon for a single
organization to support multiple different EMR/Clinical Data
Repository 5544 for different operational environments, for
example, Cardiology and ER. EMR data capture systems 5500 and 5700
in some implementations takes this into account and routes the
patient data to the correct EMR/Clinical Data Repository 5544.
Therefore the bridge 5520 is informed for a given MVS apparatus
5504 which indicates to the EMR the medical data has to be routed
to.
[0483] Segregation of operations for multiple client operations on
a single bridge 5520:
[0484] EMR data capture systems 5500 and 5700 supports per client
interfaces and functionality to ensure that each client's
configurations, performance, user accounts, security, privacy and
data protection are maintained. For single server implementations
that service multiple independent hospital groups the bridge 5520
in some implementations maintain all functionality, and performance
per client separately and ensure that separate user accounts,
bridge 5520 configuration, device operation, patient and
non-patient data, interfaces etc. are handled and isolated per
client. A multiple cloud based implementation obviates this
function as each client includes their own cloud based system.
[0485] Multiple organization device support: The bridge 5520
supports at least 1 million+MVS apparatus 5504 for a remote
implementations that services multiple separate hospital systems.
The supported MVS apparatus 5504 can be MVS apparatus 5504 from
different manufacturers.
[0486] EMR capture system support: The MVS apparatus 5504 supports
a wide range implementations of the EMR data capture system(s) 5500
and 5700 and is capable of interfacing to any commercially deployed
EMR/Clinical Data Repository 5544.
[0487] EMR capture system interface and approvals: The bridge 5520
device provides support for all required communication, encryption,
security protocols and data formats to support the transfer of PMR
information in accordance with all required operational, standards
and approval bodies for EMR/Clinical Data Repository 5544 supported
by the EMR data capture systems 5500 and 5700.
[0488] Remote EMR capture system(s): The bridge 5520 supports
interfacing to the required EMR/Clinical Data Repository 5544
independent of the EMR data capture system(s) 5500 and 5700
location, either locally on the same network infrastructure or
external to the network that the bridge 5520 is resided on or a
combination of both. The EMR data capture systems 5500 and 5700, or
systems, that the bridge 5520 is required to interact with and save
the patient to can not be located on the same network or bridge
5520 implementation location, therefore the bridge 5520
implementation in some implementations ensure that the route to the
EMR exists, and is reliable.
[0489] Bridge buffering of device patient records: The bridge 5520
device provides a mechanism to buffer received PMRs from connected
MVS apparatus 5504 in the event of a communications failure to the
EMR/Clinical Data Repository 5544, and when communications has been
reestablished subsequently transfer the buffered measurement
records to the EMR. From time to time in normal operation, the
network connection from the bridge 5520 is lost. If communications
has been lost to the configured EMR data capture system(s) 5500 and
5700 then the bridge 5520 in some implementations accepts
measurement records from the MVS apparatus 5504 and buffers the
measurement records until communications has be reestablished.
Buffering the measurement records allows the medical facility to
transfer the current data of the medical facility to the bridge
5520 for secure subsequent processing. In this event the bridge
5520 will respond to the MVS apparatus 5504 that either 1. Dynamic
validation of EMR acceptance is not possible, or 2. The bridge 5520
has accepted the data correctly.
[0490] Bridge 5520 real time acknowledge of EMR save to device: The
bridge 5520 provides a mechanism to pass to the MVS apparatus 5504
confirmation that the EMR has accepted and saved the PMR. The
bridge 5520 when configured to provide the MVS apparatus 5504 with
real time confirmation that the EMR/Clinical Data Repository 5544
(s) have accepted and validated the PMR. This is a configuration
option supported by the bridge 5520.
[0491] Bridge 5520 real time acknowledgement of acceptance of
device PMR: The bridge 5520 provides a mechanism to pass to the MVS
apparatus 5504 confirmation that the bridge 5520 has accepted the
PMR for subsequent processing to the EMR. The MVS apparatus 5504 in
some implementations verifies that the bridge 5520 has accepted the
PMR and informs the operator of the MVS apparatus 5504 that the
data is secure. This level of confirmation to the MVS apparatus
5504 is considered the minimum level acceptable for use by the EMR
data capture systems 5500 and 5700. Real time acknowledgement by
the bridge 5520 of acceptance of the PMR from the device is a
configuration option supported by the bridge 5520.
[0492] Bridge Date and Time: The bridge 5520 maintains internal
date and time against the local network time source or a source
recommended by the IT staff for the network. All transitions and
logging events in some implementations are time stamped in the logs
of the bridge 5520. The MVS apparatus 5504 will query the bridge
5520 for the current date and time to update its internal RTC. The
internal time MVS apparatus 5504 can be maintained to a+/-1 second
accuracy level, although there is no requirement to maintain time
on the MVS apparatus 5504 to sub one-second intervals.
[0493] Graphical User Interface: The bridge 5520 device provides a
graphical user interface to present system information to the
operator, or operators of EMR data capture systems 5500 and 5700.
The user interface presented to the user for interaction with EMR
data capture systems 5500 and 5700 in some implementations can be
graphical in nature and use modern user interface practices,
controls and methods that are common use on other systems of this
type. Command line or shell interfaces are not acceptable for
operator use though can be provided for use by system admin
staff.
[0494] Logging and log management: The bridge 5520 is required to
provide a logging capability that logs all actions carried out on
the bridge 5520 and provides a user interface to manage the logging
information. Standard logging facilities are acceptable for this
function for all server and user actions. Advanced logging of all
device communications and data transfers in some implementations is
also provided, that can be enabled/disable per MVS smartphone
system or for product range of MVS smartphone system.
[0495] User Accounts: The bridge 5520 device provides a mechanism
to support user accounts on the MVS apparatus 5504 for access
control purposes. Standard methods for user access control are
acceptable that complies with the operational requirements for the
install/implementation site.
[0496] User Access Control: The bridge 5520 device supports
multiple user access control that defines the access control
privileges for each type of user. Multiple accounts of each
supported account type are to be support. Access to EMR data
capture systems 5500 and 5700 in some implementations be controlled
at a functional level, In some implementations, the following
levels of access is provided:
[0497] System Admin: provides access to all features and functions
of EMR data capture systems 5500 and 5700, server and device
based.
[0498] Device Admin: provides access only to all device related
features and functions supported by the EMR data capture systems
5500 and 5700.
[0499] Device Operator: provides access only to device usage.
[0500] Device Installer: provides access only to device
commissioning and test capabilities.
[0501] A user account can be configured for permissions for one or
more account types.
[0502] Multi-User Support: The bridge 5520 device is required to
provide concurrent multi-user support for access and management of
the bridge 5520 system across all functions. Providing multiple
user access is deemed a necessary operational feature to
support.
[0503] Modify User Accounts: The bridge 5520 provides a method to
create, delete, and edit the supported user accounts and supported
access privileges per account.
[0504] Bridge Data Corruption/Recovery: The bridge 5520
architecture and implementation in some implementations ensure that
under an catastrophic failure of EMR data capture systems 5500 and
5700 or a storage component that no data is lost that has not been
confirmed as saved to the either the EMR for PMRs or localize
storage for operational data pertaining to the non-patient data
maintained by the EMR data capture systems 5500 and 5700. The
bridge 5520 supports a method to ensure zero data lost under
critical and catastrophic system failure of the bridge 5520 or any
of the bridge 5520 components, network interfaces, storage systems,
memory contents, etc. for any data handled by the EMR data capture
systems 5500 and 5700. In the event of a recovery action where a
catastrophic failure has occurred EMR data capture systems 5500 and
5700 supports both the recovery action and its normal operational
activities to ensure that EMR data capture systems 5500 and 5700 is
active for clinical use.
[0505] Bridge availability: The bridge 5520 device is a high
availably system for fail safe operation 24/7/365, with 99.99%
availability, i.e. "four nines" system. The bridge 5520
implementation meets an availability metric of 99.99%, i.e. a "four
nines" system because the bridge 5520 hardware in some
implementations is implemented with a redundant dual server
configuration to handle single fault conditions. The bridge 5520
has an independent power source or when the installation site has a
policy for power loss operation the bridge 5520 installation in
some implementations complies with the policy requirements.
[0506] Bridge Static IP address and port Number: The bridge 5520
provides a mechanism to configure the bridge 5520 for a primary use
static IP address and port number. For MVS apparatus 5504
connection to the bridge 5520, the bridge 5520 in some
implementations has a static IP address and that IP address in some
implementations is known by the MVS apparatus 5504.
[0507] Bridge Dual network capability: The bridge 5520 system
provides a mechanism to support a dual operational network
interface to allow for failure of the primary network interface.
This secondary network interface supports a configurable static IP
address and port number. A redundant network connection in some
implementations is provided to cover the event that the primary
network interface has failed. Note if the bridge 5520
implementation for EMR data capture systems 5500 and 5700 employs
two separate bridges 5520 or other redundant mechanism to provide a
backup system then this requirement can be relaxed from an
operational view point, however EMR data capture systems 5500 and
5700 in some implementations support this mechanism.
[0508] Local Wi-Fi.RTM. commissioning network: The bridge 5520
provides a mechanism on the local operational network to commission
new MVS apparatus 5504 for operational use. EMR data capture
systems 5500 and 5700 supplies a localized isolated network for the
use of commissioning new devices onto the operational network. The
bridge 5520 has a known default IP address on this network and
provides a DHCP server for the allocation of IP address to devices
on EMR data capture systems 5500 and 5700. The commissioning of new
devices is to be considered a core aspect of the bridge 5520
functions. However it is acceptable that a separate non server
based application in some implementations will manage the
configuration process provided the same user interface is presented
to the user and the same device level configuration options are
provided. In some implementations, the configuration of a new MVS
apparatus 5504 on the network is carried out in two stages: Stage
1: network configuration from the commissioning network to the
operational network. Stage 2: Once joined on the operational
network specific configuration of the MVS apparatus 5504 for
clinical/system function operation.
[0509] Remote commissioning of devices: EMR data capture systems
5500 and 5700 provides a mechanism where the bridge 5520 device is
not present on the local network for a new device is to be
commissioned on the operational network. Even when the bridge 5520
is on a cloud server external to the operational site network new
devices in some implementations can be commissioned onto the
network in the same manner as if the bridge 5520 was a local
server. This does not preclude the installation of a commission
relay server on to the operational network that supports this
mechanism.
[0510] Device setup: The bridge 5520 supports the configuration of
a device level network operation and security settings for an
existing or new MVS apparatus 5504 on either the commissioning
network or the operational network. New devices are configured on
the commissioning network. Existing devices on the operational
network are also configurable for network and security requirements
independent of the network that the MVS apparatus 5504 are
currently connected to the bridge 5520 provides the required user
interface for the configuration of the network operational and
security settings by the operator. Once configured, a method of
verifying that the MVS apparatus 5504 have been configured
correctly but be presented to the operator to prove that the MVS
apparatus 5504 are operational. Devices support a network command
to reboot and rejoin the network for this verification purpose.
[0511] Bridge Configuration: The bridge provides a mechanism to
support configuration of all required specific control options of
the bridge 5520. A method to configure the bridge 5520 functions in
some implementations is provided for all features where a
configuration option enable, disable or a range of vital-signs are
required.
[0512] Bridge MVS smartphone system acknowledgement method: The
bridge 5520 provides a configuration method to control the type of
acknowledgement required by the EMR data capture systems 5500 and
5700, one of: device configuration dependent, EMR level
acknowledgment, bridge 5520 level acknowledgement. In some
implementations, a MVS smartphone system 5504 requires from the
bridge an acknowledgement that the PMR has been saved by the EMR
data capture systems 5500 and 5700 or accepted for processing by
the bridge 5520.
[0513] EMR Level: Bridge 5520 confirms save by EMR data capture
systems 5500 and 5700.
[0514] Bridge Level: bridge 5520 controlled, accepted for
processing by the bridge 5520.
[0515] Enabled/Disable of firmware updated mechanism: The bridge
5520 provides a method to globally enable or disable the supported
MVS apparatus 5504 firmware updated feature. A global
enable/disable allows the control of the firmware update
process.
[0516] Server Management: The bridge 5520 is required to provide a
user interface that provides configuration and performance
monitoring of the bridge 5520 and platform functions.
[0517] System Reporting: The bridge 5520 is required to provide a
mechanism to provide standard reports to the operator on all
capabilities of the bridge 5520 system. Standard reporting in some
implementations includes selection of report vital-sign, sorting of
report vital-signs, printing of reports, export of reports to known
formats, WORD, excel, PDF etc., identification of reports,
organization name, location, page numbers, name of report etc.,
date and time of log, generate by user type and extent of provides
full reporting for all system features and logs, examples are: List
of devices known to EMR data capture systems 5500 and 5700, with
location reference and date and time of last connection Report on
the battery status for all known MVS apparatus 5504. Report on any
devices that reported an error Report on devices that have expired
there calibration dates. Report on devices that are approaching
their calibration dates.
[0518] Demo Patient Interface: The bridge 5520 provides a mechanism
for demo only purposes where an EMR data capture systems 5500 and
5700 is not available for interfacing to EMR data capture systems
5500 and 5700 to allow patient records received from a given device
to be viewed and the biological vital sign data presented. For
demonstrations of EMR data capture systems 5500 and 5700 where
there is no EMR data capture systems 5500 and 5700 to connect the
bridge 5520 the system provides a user interface method to present
the data sent to the bridge 5520 by the connected MVS apparatus
5504. In some implementations this patient data interface manages
and stores multiple patients and multiple record readings per
patient and present the information to the operator in an
understandable and consistent manner
[0519] Interface to EMR/clinical data repository 5544: The bridge
5520 device provides an interface to the EMR/clinical data
repository 5544 for the purpose of storing patient records. Also,
anonymous PMRs are stored for the purposes of data analysis as well
as provide a mechanism to monitor the operation of the MVS
apparatus 5504.
[0520] Device PMRs: The bridge 5520 in some implementations accepts
propriety formatted measurement records from MVS apparatus 5504
connected and configured to communicate with the bridge 5520 and
translate the received measurement record into a suitable format
for transfer to a EMR data capture systems 5500 and 5700. The
bridge 5520 is the MVS apparatus 5504 that will take the MVS
apparatus 5504 based data and translate that data into a format
suitable to pass along to a local or remote EMR/Clinical Data
Repository 5544 system using the required protocols of that
EMR/Clinical Data Repository 5544.
[0521] Device non patient measurement data: The bridge 5520 in some
implementations accepts data from connected MVS apparatus 5504 and
provides data to a connected device. This is data or setting
vital-signs associated with the MVS apparatus 5504 that in some
implementations is managed by the bridge 5520, e.g. device
configuration settings, firmware images, status information
etc.
[0522] Device to Bridge 5520 interface protocol: The bridge 5520
supports a MVS apparatus 5504 to bridge 5520 interface protocol,
BRIP, for all communications between the MVS apparatus 5504 and the
bridge 5520 device. Each device supports a single interface
protocol, BRIF and individual device or manufacture level protocols
can be supported by the bridge 5520.
[0523] Network communications method: The bridge 5520 supports a
LAN based interface for processing connection requests and data
transfers from remote MVS apparatus 5504. Standard communications
methods such as UDP/TCP/IP etc. are supported but the interface is
not restricted to this transfer mechanism, the architecture of EMR
data capture systems 5500 and 5700 in some implementations support
other transfer methods such as UDP. Where more than one MVS
apparatus 5504 type is supported in EMR data capture systems 5500
and 5700 the bridge 5520 supports different transfer mechanism
concurrently MVS apparatus 5504: The bridge 5520 in some
implementations accept connections and measurement data records
from MVS apparatus 5504.
[0524] Non-conforming MVS apparatus: The bridge 5520 in some
implementations accepts connections and measurement data records
from non-MVS apparatus 5504 using device interface protocols
specific to a given device or manufacture of a range of device. The
EMR data capture systems 5500 and 5700 support third party MVS
apparatus 5504 to provide the same core features and functions as
those outlined in this document. In some implementations, a core
system supports all MVS apparatus 5504 connected to EMR data
capture systems 5500 and 5700, for the purposes of measurement
data, body core temperature, ECG, blood pressure, plus other
biological vital signs, both single and continuous measurement
based, for transfer to the selected EMR/Clinical Data Repository
5544, along with per device configuration and status
monitoring.
[0525] Single Vital-sign Measurement Data: The bridge 5520 in some
implementations accept and processes for transfer to the configured
EMR/Clinical Data Repository 5544, single event measurement data.
Single event measurement data is defined as a patient biological
vital sign single point measurement such as a patient body core
temperature, blood pressure, heart rate or other data that is
considered a one-time measurement event for a single measurement
vital-sign. This type of data is generated from a MVS apparatus
5504 that supports a single biological vital sign reading.
[0526] Multiple Vital-sign Measurement Data: The bridge 5520 in
some implementations accept and process for transfer to the EMR
multiple event measurement data. Multiple event measurement data is
defined as a patient biological vital sign single point measurement
such as a patient blood glucose levels or other vital sign that is
considered a one-time measurement event for more than one vital
sign.
[0527] Continuous Vital-sign Measurement Data: The bridge 5520 in
some implementations accept and process for transfer to the EMR
single vital-sign continuous measurement data. Continuous
measurement data is defined as a stream of measurement samples
representing a time domain signal for a single or multiple
biological vital sign vital-sign.
[0528] Unique MVS smartphone system identification: The bridge 5520
supports a unique identifier per MVS apparatus 5504, across all
vendors and device types, for the purposes of device
identification, reporting and operations. Each MVS apparatus 5504
that is supported by the EMR data capture systems 5500 and 5700
provides a unique identification based on the manufacture, product
type, and serial number or other factors such as the FDA UID. The
bridge 5520 is required to track, take account of, and report this
number in all interactions with the MVS apparatus 5504 and for
logging. This device identification can also be used in the
authentication process when a MVS apparatus 5504 connects to the
bridge 5520.
[0529] Device connection authentication: The bridge 5520 provides a
mechanism to authenticate a given MVS apparatus 5504 on connection
to ensure that the MVS apparatus 5504 are known and allowed to
transfer information to the bridge 5520. Access to the bridge 5520
functions in some implementations is controlled in order to
restrict access to currently allowed devices only. Acceptance of a
MVS apparatus 5504 making connection the bridge 5520 for 2 main
rationales. 55. The MVS apparatus 5504 are known to the bridge
5520, and that 2. A management function to control access for a
given device, i.e. allow or bar access.
[0530] Last connection of device: The bridge 5520 is required
maintain a history of the connection dates and times for a given
MVS apparatus 5504. This is required from a reporting and logging
viewpoint. In some implementations will also be used to determine
if a MVS apparatus 5504 are lost/stolen or failed.
[0531] Calibration/Checker Monitoring: The bridge 5520 is required
to track the valid calibration dates for a given device and present
to the operator those devices that are out of calibration or
approaching calibration. All MVS apparatus 5504 in some
implementations be checked for operation and accuracy on a regular
bases. EMR data capture systems 5500 and 5700 can provide the
facility to generate a report and highlight devices that are either
out of calibration and those approaching calibration. The check
carried out by the bridge 5520 is on the expiry date exposed by the
MVS apparatus 5504. The bridge 5520 is not required to check the
MVS apparatus 5504 for calibration, only report if the MVS
apparatus 5504 are out of calibration based on the MVS apparatus
5504 expiry date. In some implementations the expiry date is
updated at the time of the MVS apparatus 5504 recalibration
check.
[0532] Error/Issue monitoring: The bridge 5520 is required to track
the issues/errors reported by a given device and present that
information to the operator in terms of a system report. Reporting
of device level errors dynamically for a given device is
diagnostics tool for system management. Providing the issue/error
history for a given device provides core system diagnostic
information for the MVS apparatus 5504.
[0533] Battery Life monitoring: The bridge 5520 is required to
track the battery level of a given device and report the battery
level information to the operator. EMR data capture systems 5500
and 5700 is to highlight to the operator that a given device has an
expired or nearly expired or failed internal battery based on the
information exposed by the MVS apparatus 5504. It is the MVS
apparatus 5504 responsibility to determine its own internal power
source charge level or battery condition. The bridge 5520 can
provide a mechanism to report the known battery condition for all
devices, e.g. say all devices that have 10% battery level
remaining
[0534] Lost/Stolen/Failed monitoring: The bridge 5520 is required
to determine for a given MVS apparatus 5504 if it has been
lost/stolen/or failed and disable the MVS apparatus 5504 for system
operation. Being able to determine if a system has not connected to
the bridge 5520 for a period of time is a feature for failed, lost
or stolen reporting to the operator. If a MVS apparatus 5504 has
not connected to EMR data capture systems 5500 and 5700 for a
period of time, EMR data capture systems 5500 and 5700 determines
that the MVS apparatus 5504 has been stolen or lost, in this event
the operator is informed in terms of a system report and the MVS
apparatus 5504 removed from the supported devices list. If and when
the MVS apparatus 5504 reconnects to EMR data capture systems 5500
and 5700 the MVS apparatus 5504 are to be lighted as "detected" and
forced to be rechecked and re-commissioned again for use on the
network.
[0535] Reset device to network default: A method to reset a target
device or group of selected devices to factory settings for all
network parameters in some implementations.
[0536] Reset device to factory default: A method to reset a target
device or group of selected devices to their factory default
settings in some implementations is supported.
[0537] Dynamic Device Parameter Configuration: The bridge 5520
provides a mechanism to provide configuration information to a MVS
apparatus 5504 when requested by the MVS apparatus 5504 on
connection to the bridge 5520 or via the keep device alive
mechanism. Upon connecting to a bridge 5520 a MVS apparatus 5504 as
part of the communications protocol determines if its current
configuration is out of date, if any aspect of the MVS apparatus
5504 configuration is out of date and is required to be updated
then the bridge 5520 provides the current configuration information
for the MVS apparatus 5504 model and revision This is intended to
be as simple as the MVS apparatus 5504 getting the configuration
setting for each of its supported parameters. The bridge 5520 is
responsible to ensure that the supplied information is correct for
the MVS apparatus 5504 model and revision level.
[0538] Device Configuration Grouping: Single device: The bridge
5520 provides a mechanism to configure a single device, based on
unique device ID, to known configuration parameters. The bridge
5520 in some implementations allows a single MVS apparatus 5504 to
be updated when it connects to the bridge 5520 either via the heart
beat method or via operator use. This effectively means that the
bridge 5520 provides a method to manage and maintain individual
device configuration settings and have those settings available
dynamically for when the MVS apparatus 5504 connects. Further the
bridge 5520 supports per device configurations for different
revisions of device firmware, for example revision 1 of the MVS
apparatus 5504 has configuration parameters x, y and z, but
revision 2 of the MVS apparatus 5504 has configuration parameters
has x, y, z and k and the valid allowed range for the y parameter
has been reduced.
[0539] Device Configuration Grouping--MVS apparatus 5504 model
group: The bridge 5520 provides a mechanism to configure all
devices within a model range to known configuration parameters. The
facility to reconfigure a selected sub-group of devices that are
model x and at revision level all with the same configuration
information.
[0540] Device Configuration Grouping--selected group within model
range: The bridge 5520 provides a mechanism to configure a selected
number of devices within the same model range to known
configuration parameters. The facility to reconfigure a selected
sub-group of devices that are model x and at revision level y
Device Configuration Grouping--defined sub group: The bridge 5520
provides a mechanism to configure a selected number of devices with
the same model based on device characteristics e.g. revision level,
operational location etc. The facility to reconfigure all devices
that are model x and at revision level y, OR all model x devices
that are in operation in Ward 6 is a feature.
[0541] Device Configuration files: The bridge 5520 provides a
method to save, load, update and edit a configuration file for a
MVS apparatus 5504 model number and/or group settings. The ability
to save and load configuration files and change the configuration
content in the file is a required feature for EMR data capture
systems 5500 and 5700. A file management mechanism in some
implementations is also provided for the saved configuration
files.
[0542] Dynamic configuration content: The bridge 5520 in some
implementations dynamically per MVS apparatus 5504 connection
determine upon request by the MVS apparatus 5504 the new
configuration settings for that device, given that the medical
devices connect in a random manner to the bridge 5520, the bridge
5520 is required for the connected device, model, revision, unique
identification etc. to maintain the configuration settings for that
device.
[0543] The bridge 5520 provides a mechanism to control the patient
record received from a MVS apparatus 5504 to transfer the record to
one or more of the supported EMR/Clinical Data Repository 5544.
Where more than one EMR/Clinical Data Repository 5544 is maintained
by a single organization, e.g. one for ER, cardiology use and
possibility one for outpatients etc. EMR data capture systems 5500
and 5700 in some implementations manage either by specific device
configuration or bridge 5520 configuration which EMR the patient
record is to be transmitted to by the bridge 5520.
[0544] Device Configuration and Status Display: In some
implementations, when a MVS apparatus 5504 connects to the bridge
5520 that the MVS apparatus 5504 queries its current configuration
settings against the bridge 5520 settings for that specific device
type and device as outlined below: 1. A given device based on a
unique ID for that device. Note each device is required to be
uniquely identified in EMR data capture systems 5500 and 5700. 2. A
group of devices allocated to a physical location in the hospital,
i.e. Based on a ward number of other unique location reference.
Accordingly, in some implementations a group of devices in a given
location in some implementations is updated separately from other
devices of the same type located in a different location in the
same hospital environment, i.e. a recovery ward 1 as opposed to an
emergency room. A group of devices based on product type, i.e. all
MVS apparatus 5504, updated with the same settings. Bridge 5520
device configuration options adjusted based on MVS apparatus 5504.
The bridge 5520 in some implementations adjusts the configuration
options presented to the operator based on the capabilities of the
MVS apparatus 5504 being configured. Where multiple different MVS
apparatus 5504 are supported by the EMR data capture systems 5500
and 5700 it cannot be assumed that each device from a different
manufacture or from the same manufacture but a different model of
the same device level configuration parameters. Therefore the
bridge 5520 in some implementations determine the configuration
capabilities for the MVS apparatus 5504 to be configured and
present only valid configuration options for that device with valid
parameter ranges for these options.
[0545] Device parameter Validation: The bridge 5520 provides a
mechanism for a given model MVS apparatus 5504 to validate that a
given configuration parameter is set within valid parameter ranges
for that device model and revision. The bridge 5520 is required
based on the MVS apparatus 5504 model and revision level to present
valid parameter ranges for the operator to configure a MVS
apparatus 5504 level parameter with. Device patient record
acceptance check response source. The bridge 5520 provides a
mechanism to configure the MVS apparatus 5504 to require either: 1)
a confirmation from the bridge 5520 device only that a patient
record has been received for processing or 2) a confirmation from
the bridge 5520 device that the EMR data capture systems 5500 and
5700 has received and saved the patient information. In some
implementations of the configuration of the MVS apparatus 5504 the
MVS apparatus 5504 reports to the operator a status indicator.
[0546] Device Hospital/Clinic Reference: A device setting to allow
an organization identifier to be configured on the MVS apparatus
5504. The MVS apparatus 5504 can be configured with an alphanumeric
identification string, max 30 characters that allows the
organization to indicate to the hospital/clinic that the MVS
apparatus 5504 are in use with, e.g. "Boston General".
[0547] Device Ward Location reference: A device setting to allow an
operational location identifier to be configured on the MVS
apparatus 5504. The MVS apparatus 5504 are to be configured with an
alphanumeric identification string, max 30 characters that allows
the organization to indicate an operational area within the
organization, e.g. "General Ward #5".
[0548] Device Asset Number: A device setting to allow an
organization asset number to be configured on the MVS apparatus
5504. The MVS apparatus 5504 are to be configured with an
alphanumeric identification string, max 30 characters to allow the
organization to provide an asset tag for the MVS apparatus
5504.
[0549] Display device Manufacture Name, Device Model and Serial
Number: A method to display the manufacture name, device model
number and device serial number for the unit is provided. EMR data
capture systems 5500 and 5700 can provide a method to determine the
manufacturer name, model number and device level serial number of
for the MVS smartphone system 5504. Alphanumeric identification
string, max 60 characters in length for each of the three
parameters.
[0550] Display MVS apparatus 5504 unique identification reference
tag: A method to display the device level unique identifier for the
unit. For regulatory traceability reasons each device is to support
a unique identification number this number in some implementations
be displayed by the EMR data capture systems 5500 and 5700.
[0551] Device last Check/Calibration Date: A method to display and
set the date of the last check or re-calibration action for the MVS
apparatus 5504. This allows the bridge 5520 to determine which
devices are required to be re-checked and present that information
to the operator of EMR data capture systems 5500 and 5700. All MVS
apparatus 5504 with a measurement function are required to be
checked for accuracy on a regular basis. EMR data capture systems
5500 and 5700 provides a mechanism to update the MVS apparatus 5504
date of last check/calibration when a device level check has been
carried out.
10. Methods of Multi-Vital-Sign_Detection and Communication
[0552] In this section, the particular methods performed by FIGS.
13, 30, 35, 36, 37 and 41 are described by reference to a series of
flowcharts.
[0553] FIG. 58 is a flowchart of a method 5800 to perform real time
quality check on finger cuff data, according to an implementation.
The method 5800 uses signals from physiological light monitoring
(PLM) subsystems to perform quality check. The method 5800 can be
performed by any of the printed circuit boards or any of the
microprocessors in FIG. 1-37, such as the printed circuit board 106
in FIGS. 1-7 and 12, the MVS finger cuff accessory (MVSFCA) 3002 in
FIG. 30, the MVSFCA 3102 in FIG. 31, the sensor management
component 3302 in FIG. 33, the microprocessor 3320 in FIG. 33, the
MVS finger cuff 1904 in FIG. 19 and FIG. 11, the microprocessor
1902 in FIG. 19, controller 2020 in FIG. 20, the microprocessor
3502 in FIGS. 35-40 and 41 and/or main processor 2802 in FIG.
28.
[0554] In method 5800, raw data 5802 is received from a PLM
subsystem, such as PLM subsystem in the MVS finger cuff in FIG.
1-18, 1904 in FIGS. 19, 31 and 33, FIGS. 21-27, 30-34 and/or 3544
in FIG. 35-40, raw data 5804 is received from two mDLS sensors,
such as mDLS sensor in the MVS finger cuff in FIG. 1-18, 1904 in
FIGS. 19, 31 and 33 and/or 3542 in FIG. 35-40, raw data 5806 is
received from pressure cuff, such as MVS finger cuff in FIG. 1-18,
1904 in FIGS. 19, 31 and 33 and/or 3542 in FIGS. 35-40 and/or the
pressure sensor 4208 in FIG. 42, raw data 5824 is received from an
accelerometer and raw data 5832 is received from a three-axis
gyroscope. The raw data 5806 received from the pressure cuff can be
received from the pneumatic pressure sensor 4208 in FIG. 42.
[0555] The raw data 5802 that is received from the PLM subsystem is
analyzed in PLM signal processing 5808, the raw data 5804 that is
received from the mDLS sensors is analyzed in mDLS signal
processing 5810, the raw data 5806 that is received from the
pressure cuff is analyzed in cuff pressure processing 5812, the raw
data 5824 that is received from the accelerometer is analyzed in
accelerometer processing 5826 and the raw data 5832 that is
received from the three axis gyroscope is analyzed in gyroscope
processing 5834. If the analysis in the PLM signal processing 5808
and the mDLS signal processing 5810 indicates a poor
signal-to-noise ratio 5814 in the raw data 5802 that is received
from the PLM subsystem or the raw data 5804 that is received from
the mDLS sensors, the measurement is ended 5815. If the analysis in
the PLM signal processing 5808 and the mDLS signal processing 5810
indicates a good signal-to-noise ratio 5814 in both the raw data
5802 that is received from the PLM subsystem and the raw data 5804
that is received from the mDLS sensors, then a waveform analysis
5818 is performed on both the raw data 5802 that is received from
the PLM subsystem and the raw data 5804 that is received from the
mDLS sensors. If the analysis in the cuff pressure processing 5812
indicates the bladder of the finger occlusion cuff can not be
inflated to a required pressure or that the required amount of
pressure can not be maintained in the bladder of the MVS finger
cuff 5816 then the measurement is ended 5815. If the analysis in
the accelerometer processing 5826 indicates unreliable data from
the accelerometer, then the measurement is ended 5815. If the
analysis in the three axis gyroscope processing 5834 indicates
unreliable data from the three axis gyroscope, then the measurement
is ended 5815.
[0556] From the waveform analysis 5818 that is performed on both
the raw data 5802 that is received from the PLM subsystem and the
raw data 5804 that is received from the mDLS sensors, flags
indicating that status of heartrate, respiratory rate and/or are
generated 5820. From the cuff pressure processing 5812, flags
indicating the blood pressure (diastolic and systolic) are
generated 5822. From the accelerometer processing 5826, flags
indicating the quality of the accelerometer data 5824 are generated
5830. From the three axis gyroscope processing 5834, flags
indicating the quality of the three axis gyroscope data 5832 are
generated 5838.
[0557] FIG. 59 is a flowchart of a method 5900 to estimate a body
core temperature from a digital infrared sensor, according to an
implementation. Method 5900 includes receiving from the digital
readout ports of a digital infrared sensor a digital signal that is
representative of an infrared signal of a forehead temperature that
is detected by the digital infrared sensor, at block 5902. No
signal that is representative of the infrared signal is received
from an analog infrared sensor.
[0558] Method 5900 also includes estimating a body core temperature
from the digital signal that is representative of the infrared
signal, at block 5904.
[0559] FIG. 60 is a flowchart of a method 6000 to display body core
temperature color indicators, according to an implementation of
three colors. Method 6000 provides color rendering to indicate a
general range of a body core temperature.
[0560] Method 6000 includes receiving the body core temperature
(such as digital readout signal 3511 that is representative of the
infrared signal 3516 of the forehead in FIG. 35), at block
6001.
[0561] Method 6000 also includes determining whether or not the
body core temperature is in a first range, such as a range of
32.0.degree. C. and 37.3.degree. C., at block 6002. If the body
core temperature is in the first range, then the color is set to
`amber` to indicate a body core temperature that is low, at block
6004 and a lighting emitting diode (LED) (such as LED 316) or the
background of the display of the smartphone is activated in
accordance with the color, at block 6006.
[0562] If the body core temperature is not the first range, then
method 6000 also includes determining whether or not the body core
temperature is in a second range that is immediately adjacent and
higher than the first range, such as a range of 37.4.degree. C. and
35.0.degree. C., at block 6008. If the body core temperature is in
the second range, then the color is set to green to indicate no
medical concern, at block 6010 and the LED (such as LED 316) or the
background of the display is activated in accordance with the
color, at block 6006.
[0563] If the body core temperature is not the second range, then
method 6000 also includes determining whether or not the body core
temperature is over the second range, at block 6012. If the body
core temperature is over the second range, then the color is set to
`red` to indicate alert, at block 6012 and the LED (such as LED
316) or the background is activated in accordance with the color,
at block 6006.
[0564] Method 6000 assumes that body core temperature is in
gradients of 10ths of a degree. Other body core temperature range
boundaries are used in accordance with other gradients of body core
temperature sensing.
[0565] In some implementations, some pixels in the LED or the
display are activated as an amber color when the body core
temperature is between a first range of 36.3.degree. C. and
37.3.degree. C. (97.3.degree. F. to 99.1.degree. F.), some pixels
in the display are activated as a green when the body core
temperature is between a second range of 37.4.degree. C. and
37.9.degree. C. (99.3.degree. F. to 100.2.degree. F.), the LED or
some pixels in the display are activated as a red color when the
body core temperature is greater than the second range (a least
35.degree. C. (100.4.degree. F.)).
[0566] FIG. 61 is a flowchart of a method 6100 to manage power in a
non-touch device having a digital infrared sensor, according to an
implementation. The method 6100 manages power in the devices 1-37,
in order to reduce heat pollution in the digital infrared
sensor.
[0567] To prevent or at least reduce heat transfer between digital
infrared sensor 3508 and a microprocessor (such as the digital
infrared sensor 3508 and the microprocessor 3502, main processor
2802 in FIG. 28, the components of the MVS smartphone systems in
FIG. 30-34, the apparatus that estimates a body core temperature in
FIG. 38-41), the apparatus of motion amplification in FIGS. 46-54
and the MVS smartphone 2800 are power controlled, i.e. sub-systems
are turned on and off, and the sub-systems are only activated when
needed in the measurement and display process, which reduces power
consumption and thus heat generation by the microprocessor 3502, or
main processor 2802 in FIG. 28, of the MVS smartphone systems in
FIG. 30-34, the apparatus that estimates a body core temperature in
FIG. 38-40, the apparatus of motion amplification in FIG. 46-54,
the MVS smartphone 2800, respectively. When not in use, at block
6102, the MVS smartphone systems in FIG. 30-34, the apparatus that
estimates a body core temperature in FIG. 38-41, the apparatus of
motion amplification in FIGS. 46-54 and the MVS smartphone 2800 are
completely powered-off, at block 6104 (including the main PCB
having the microprocessor 3502, main processor 2802 in FIG. 28 and
the sensor PCB having the digital infrared sensor 3508) and not
drawing any power, other than a power supply, i.e. a boost
regulator, which has the effect that the MVS smartphone systems in
FIG. 1-37, the apparatus that estimates a body core temperature in
FIG. 38-40, the apparatus of motion amplification in FIGS. 46-54
and the MVS smartphone 2800 draw only micro-amps from the battery
3504 while in the off state, which is required for the life time
requirement of 3 years of operation, but which also means that in
the non-use state there is very little powered circuitry in the MVS
smartphone systems in FIG. 30-34, the apparatus of motion
amplification in FIGS. 46-54 and the MVS smartphone 2800 and
therefore very little heat generated in the MVS smartphone systems
in FIG. 30-34, the apparatus of motion amplification in FIGS. 46-54
and the MVS smartphone 2800.
[0568] When the MVS smartphone systems in FIG. 30-34, the apparatus
that estimates a body core temperature in FIG. 38-40, the apparatus
of motion amplification in FIGS. 46-54 and the MVS smartphone 2800
are started by the operator, at block 6106, only the microprocessor
3502, microprocessor 3502, main processor 2802. In FIG. 28, main
processor 2802 in FIG. 28, digital infrared sensor 3508, and in
some implementations low power LCD (e.g. display device 3514) are
turned on for the first 1 second, at block 6108, to take the
temperature measurement via the digital infrared sensor 3508 and
generate the body core temperature result via a microprocessor in
FIG. 1-37 at block 6110. In this way, the main heat generating
components (the display device 3514, the main PCB having the
microprocessor 3502 and the sensor PCB having the digital infrared
sensor 3508), the display back-light and the body core temperature
traffic light) are not on and therefore not generating heat during
the critical start-up and measurement process, no more than 1
second. After the measurement process of block 6110 has been
completed, the digital infrared sensor 3508 is turned off, at block
6112, to reduce current usage from the batteries and heat
generation, and also the display back-light and temperature range
indicators are turned on, at block 6114.
[0569] The measurement result is displayed for 4 seconds, at block
6116, and then the MVS smartphone systems in FIG. 30-34, the
apparatus that estimates a body core temperature in FIG. 1-37, the
apparatus of motion amplification in FIGS. 46-54 and the MVS
smartphone 2800 are put in low power-off state, at block 6118.
[0570] In some implementations of methods and apparatus of FIG.
1-37 an operator can take the temperature of a subject and from the
temperatures to estimate the temperature at a number of other
locations of the subject.
[0571] The correlation of action can include a calculation based on
Formula 1:
T.sub.body=|f.sub.stb(T.sub.surface
temp)+f.sub.ntc(T.sub.ntc)+F4.sub.body|
[0572] Formula 1
[0573] where T.sub.body is the temperature of a body or subject
[0574] where f.sub.stb is a mathematical formula of a surface of a
body
[0575] where f.sub.ntc is mathematical formula for ambient air
temperature reading
[0576] where T.sub.surface temp is a surface temperature estimated
from the sensing.
[0577] where T.sub.ntc is an ambient air temperature reading
[0578] where F4.sub.body is a calibration difference in axillary
mode, which is stored or set in a memory of the apparatus either
during manufacturing or in the field. The apparatus also sets,
stores and retrieves F4.sub.oral, F4.sub.core, and F4.sub.rectal in
the memory.
[0579] f.sub.ntc(T.sub.ntc) is a bias in consideration of the
temperature sensing mode. For example
f.sub.axillary(T.sub.axillary)=0.2.degree. C.,
f.sub.oral(T.sub.oral)=0.4.degree. C.,
f.sub.rectal(T.sub.rectal)=0.5.degree. C. and
f.sub.core(T.sub.core)=0.3.degree. C.
[0580] Apparatus in FIG. 46-54 use spatial and temporal signal
processing to generate a biological vital sign from a series of
digital images.
[0581] FIG. 62 is a flowchart of a method 6200 to estimate a body
core temperature from an external source point in reference to a
body core temperature correlation table, according to an
implementation.
[0582] Method 6200 includes receiving from a non-touch
electromagnetic sensor a numerical representation of
electromagnetic energy of the external source point of a subject,
at block 6202.
[0583] Method 6200 also includes estimating the body core
temperature of the subject from the numerical representation of the
electromagnetic energy of the external source point, a
representation of an ambient air temperature reading, a
representation of a calibration difference, and a representation of
a bias in consideration of the temperature sensing mode, at block
6204. The estimating at block 6204 is based on a body core
temperature correlation table representing the body core
temperature and the numerical representation of the electromagnetic
energy of the external source point.
[0584] A body core temperature correlation table provides best
results because a linear or a quadratic relationship provides
inaccurate estimates of body core temperature, yet a quartic
relationship, a quintic relationship, sextic relationship, a septic
relationship or an octic relationship provide estimates along a
highly irregular curve that is far too wavy or twisting with
relatively sharp deviations.
[0585] Method 6200 also includes displaying the body core
temperature, at block 6206.
[0586] FIG. 63 is a flowchart of a method 6300 to estimate a body
core temperature from an external source point and other
measurements in reference to a body core temperature correlation
table, according to an implementation;
[0587] Method 6300 includes receiving from a non-touch
electromagnetic sensor a numerical representation of
electromagnetic energy of the external source point of a subject,
at block 6302.
[0588] Method 6300 also includes estimating the body core
temperature of the subject from the numerical representation of the
electromagnetic energy of the external source point, a
representation of an ambient air temperature reading, a
representation of a calibration difference, and a representation of
a bias in consideration of the temperature sensing mode, at block
6304. The estimating at block 6304 is based on a body core
temperature correlation table representing three thermal ranges
between the body core temperature and the numerical representation
of the electromagnetic energy of the external source point.
[0589] Method 6300 also includes displaying the body core
temperature, at block 6206.
[0590] In some implementations, methods 5400 and 5800-6400 are
implemented as a sequence of instructions which, when executed by a
microprocessor in FIG. 1-37, cause the processor to perform the
respective method. In other implementations, methods 5400 and
5800-6400 are implemented as a computer-accessible medium having
computer executable instructions capable of directing a
microprocessor, such as microprocessor in FIG. 1-37, to perform the
respective method. In different implementations, the medium is a
magnetic medium, an electronic medium, or an optical medium.
[0591] FIG. 64 is a block diagram of a method of MVS (MVS)
detection and communication method 6400, according to an
implementation. The MVS detection and communication method 6400 in
FIG. 64 can include any combination and permutation of three
general processes including glucose and other monitoring at block
6402, temperature monitoring at block 6404 and motion amplification
monitoring 6406.
[0592] The glucose and other monitoring 6402 in FIG. 64 includes
receiving data from a SpO2/glucose subsystem having photodiode
receivers of ER at block 6408. One example of the SpO2/glucose
subsystem is Physiological Light Monitoring (PLM) subsystem in FIG.
1 and Physiological Light Monitoring (PLM) subsystem 304 in FIG. 3.
In some implementations, the glucose and other monitoring 6402 also
includes estimating a blood glucose level from the data of the
photodiode receivers at block 6410. In some implementations, the
glucose and other monitoring at block 6402 includes estimating an
SpO2 level from the data of the photodiode receivers 6412. The
glucose and other monitoring 6402 thereafter includes estimating a
heart rate, a respiration rate, a heart rate variability and a
blood pressure diastolic from the data of the photodiode receivers
at block 6414.
[0593] One implementation of the temperature monitoring 6404 in
FIG. 64 includes detecting through an infrared sensor an infrared
signal that is representative of a body surface temperature at
block 6416, receiving the body surface temperature from the digital
infrared sensor at block 6418 and providing a vital sign (such as a
body core temperature) correlated to the body surface temperature
at block 6420.
[0594] Other implementations of the temperature monitoring 6404 in
FIG. 64 include methods in FIG. 59-63. The temperature monitoring
6404 in FIG. 64 can be performed by apparatus in FIGS. 12-27,
30-36, 38-41 and 45.
[0595] The motion amplification monitoring at block 6406 in FIG. 64
includes examining pixel values of a plurality of images at block
6424, determining a temporal motion of the pixel values between the
plurality of images being below a particular threshold at block
6426, amplifying the temporal motion resulting in an amplified
temporal motion at block 6428 and visualizing a pattern of flow of
blood in the amplified temporal-motion in the plurality of images
and block 6430.
[0596] After completion of the glucose and other monitoring 6402,
the temperature monitoring 6404 and/or the motion amplification
monitoring 6406, the vital signs are transmitted from a wireless
communication subsystem via a short distance wireless communication
path at block 6432. In some implementations, the vital signs are
transmitted by the communication subsystem through an Internet
Protocol tunnel at block 6434. One implementation of the
communication subsystem is communication subsystem 2804 In FIG.
44.
11. Displays of Multi-Vital-Sign Smartphones
[0597] FIG. 65 is a display screen 6500 of the MVS smartphone 3103
showing results of successful multi-vital sign measurements,
according to an implementation. The display screen 6500 includes
display of the blood glucose levels 6502, heartrate variability
6504, battery charge level 6506, measured blood pressure 6510
(systolic and diastolic in terms of millimeters of mercury) of the
patient, measured core temperature 6512, measured heartrate in
beats per minute 6514, measured SpO2 levels 6516 in the patient
bloodstream and/or measured respiratory rate 6518 in terms of
breaths per minute of the patient. Other data that can be displayed
by display screen 6500 is level of Wi-Fi.RTM. connectivity or the
level of Bluetooth.RTM. connectivity or the level of cellular
connectivity, the current time and the patient name of the patient
whose vital signs are measured. In other implementations,
Zigbee.RTM. or Z-Wave.RTM. can be used instead of
Bluetooth.RTM..
CONCLUSION
[0598] A MVS device senses blood glucose levels, body core
temperature, heart rate, heart rate variability, respiration, SpO2,
blood flow and/or blood pressure and transmits the vital signs to
an electronic medical record system. In some implementations, the
transmission is performed through a smartphone. A technical effect
of the apparatus and methods disclosed herein is wireless
electronic transmission of a plurality of vital signs, including
blood glucose levels from an electromagnetic sensor, to an
electronic medical record system. Another technical effect of the
apparatus and methods disclosed herein is generating a temporal
motion of images from which a biological vital sign can be
transmitted to an electronic medical record system. Although
specific implementations are illustrated and described herein, it
will be appreciated by those of ordinary skill in the art that any
arrangement which is generated to achieve the same purpose may be
substituted for the specific implementations shown. This
application is intended to cover any adaptations or variations.
Further implementations of power supply to all devices includes A/C
power both as a supplemental power supply to battery power and as a
substitute power supply.
[0599] In particular, one of skill in the art will readily
appreciate that the names of the methods and apparatus are not
intended to limit implementations. Furthermore, additional methods
and apparatus can be added to the modules, functions can be
rearranged among the modules, and new modules to correspond to
future enhancements and physical devices used in implementations
can be introduced without departing from the scope of
implementations. One of skill in the art will readily recognize
that implementations are applicable to future vital sign and
non-touch temperature sensing devices, different temperature
measuring sites on humans or animals, new communication protocols
for transmission (of user service, patient service, observation
service, and chart service) and all current and future application
programming interfaces and new display devices.
[0600] The terminology used in this application meant to include
all temperature sensors, processors and operator environments and
alternate technologies which provide the same functionality as
described herein.
* * * * *