U.S. patent application number 16/056524 was filed with the patent office on 2019-11-21 for apparatus in electronic medical records systems that determine and communicate multi-vital-signs from electromagnetic radiation .
This patent application is currently assigned to ARC Devices Ltd.. The applicant listed for this patent is ARC Devices Ltd.. Invention is credited to Irwin Gross, Mark Khachaturian, Michael Smith.
Application Number | 20190350470 16/056524 |
Document ID | / |
Family ID | 67954419 |
Filed Date | 2019-11-21 |
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United States Patent
Application |
20190350470 |
Kind Code |
A1 |
Khachaturian; Mark ; et
al. |
November 21, 2019 |
Apparatus in Electronic Medical Records Systems that Determine and
Communicate Multi-Vital-Signs from Electromagnetic Radiation of a
Subject
Abstract
In some implementations, an apparatus includes a physiological
light monitoring subsystem that includes a source-detector assembly
having a first side that has three transmitters of electromagnetic
radiation frequencies in ranges of 375-415 nm, 640-680 nm and
920-960 nm frequencies 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,
a microprocessor configured to determine an indication of an amount
of glucose in the subject calculated from a ratio of
electromagnetic radiation received by a first photodiode receiver
of electromagnetic radiation in the 350-1100 nm range to measure an
amount of electromagnetic radiation that is absorbed by the subject
at the 375-415 nm frequency range in comparison to electromagnetic
radiation received at the 920-960 nm frequency range, the subject
being positioned between the first side and a second side.
Inventors: |
Khachaturian; Mark; (Boca
Raton, FL) ; Smith; Michael; (Lakeway, TX) ;
Gross; Irwin; (Boca Raton, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ARC Devices Ltd. |
Dublin |
|
IE |
|
|
Assignee: |
ARC Devices Ltd.
Dublin
IE
|
Family ID: |
67954419 |
Appl. No.: |
16/056524 |
Filed: |
August 7, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15985672 |
May 21, 2018 |
|
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16056524 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/02055 20130101;
A61B 5/14542 20130101; A61B 2562/0219 20130101; A61B 2560/0214
20130101; G06T 3/40 20130101; G16H 30/40 20180101; A61B 5/0077
20130101; A61B 5/1495 20130101; A61B 5/02241 20130101; A61B 5/0008
20130101; A61B 5/14551 20130101; A61B 5/746 20130101; G06T 2210/22
20130101; A61B 5/7278 20130101; A61B 2562/0247 20130101; A61B 5/01
20130101; A61B 5/0022 20130101; A61B 5/14532 20130101; A61B 5/02405
20130101; A61B 5/0075 20130101; G16H 50/20 20180101; A61B 5/0816
20130101; G16H 10/60 20180101 |
International
Class: |
A61B 5/0205 20060101
A61B005/0205; A61B 5/145 20060101 A61B005/145; A61B 5/1455 20060101
A61B005/1455; A61B 5/00 20060101 A61B005/00; A61B 5/01 20060101
A61B005/01; G16H 10/60 20180101 G16H010/60; G06T 3/40 20060101
G06T003/40 |
Claims
1. An apparatus comprising: a microprocessor; a physiological light
monitoring subsystem operably coupled to the microprocessor, the
physiological light monitoring subsystem including a
source-detector assembly having a first flexible side and a second
flexible side; and a hard structure surrounding at least a portion
of the physiological light monitoring subsystem, the first flexible
side having three transmitters of electromagnetic radiation
frequencies in ranges of 375-415 nm, 640-680 nm and 920-960 nm
frequencies 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, the
source-detector assembly also having a first photodiode receiver of
electromagnetic radiation in the 350-1100 nm range to measure an
amount of electromagnetic radiation that is absorbed by the
subject, the microprocessor configured to determine an indication
of an amount of oxygen in the subject calculated from a ratio of
electromagnetic radiation received at the 640-680 nm frequency
range in comparison to electromagnetic radiation received at the
920-960 nm frequency range, the microprocessor configured to
determine an indication of an amount of glucose in the subject
calculated from a ratio of electromagnetic radiation received at
the 375-415 nm frequency range in comparison to electromagnetic
radiation received at the 920-960 nm frequency range, the subject
being positioned between the first flexible side and the second
flexible side.
2. The apparatus of claim 1 further comprising a main body
comprising the microprocessor, the main body further comprising a
visual display component that is operably coupled to the
microprocessor and a USB port that is operably coupled to the
microprocessor.
3. The apparatus of claim 1 wherein the first photodiode receiver
of electromagnetic radiation in the second flexible side receives
the electromagnetic radiation at the 640-680 nm frequency range and
wherein the first photodiode receiver of electromagnetic radiation
in the first flexible side receives the electromagnetic radiation
at the 375-415 nm frequency range.
4. The apparatus of claim 3 the source-detector assembly further
comprising a light shielding that shields extraneous near-infrared
and extraneous ambient light such that electromagnetic radiation
entering the subject as well as the electromagnetic radiation
detected will be only in the 350-1100 nm range of the first
photodiode receiver of electromagnetic radiation and the 350-1100
nm range of the first photodiode receiver of electromagnetic
radiation.
5. The apparatus of claim 3 having no further receivers or
transmitters.
6. The apparatus of claim 3 wherein the apparatus is verified by a
second apparatus as known by the second apparatus and as allowed by
the second apparatus to transfer information to the second
apparatus.
7. The apparatus of claim 3 further comprising a digital infrared
sensor having no analog sensor readout ports.
8. The apparatus of claim 7, wherein a digital infrared sensor
further comprises an analog-to-digital converter.
9. The apparatus of claim 3 not including a finger occlusion
cuff.
10. The apparatus of claim 3 further comprising: a first circuit
board including: the microprocessor; the microprocessor operably
coupled to the physiological light monitoring subsystem; and a
first digital interface that is operably coupled to the
microprocessor.
11. The apparatus of claim 10 further comprising a first housing
that contains the first circuit board and an aperture for a camera
and that does not contain the camera.
12. The apparatus of claim 11 further comprising: a second circuit
board in a smartphone, the smartphone having a second housing and
the camera, the second circuit board including: a second digital
interface, the second digital interface being operably coupled to
the first digital interface; and a second microprocessor operably
coupled to the second digital interface, the second microprocessor
being configured to determine a plurality of vital signs.
13. The apparatus of claim 12 wherein a wireless communication
subsystem is operably coupled to the second microprocessor and the
wireless communication subsystem is configured to transmit a
representation of each of the plurality of vital signs via a short
distance wireless communication path.
14. The apparatus of claim 13 wherein a connection is established
and the plurality of vital signs are pushed from the apparatus
through the wireless communication subsystem, thereafter an
external device controls transmission of the plurality of vital
signs between the apparatus and the external device, wherein the
connection further comprises an authenticated communication
channel.
15. The apparatus of claim 13, wherein the wireless communication
subsystem further comprises a component that is configured to
transmit a representation of date and time, operator
identification, patient identification, manufacturer and model
number of the apparatus.
16. The apparatus of claim 12 further comprising: the camera that
is operably coupled to the second microprocessor and configured to
provide a plurality of images to the second microprocessor; and the
microprocessor including a cropper module that is configured to
receive the plurality of images and configured to crop the
plurality of images to exclude a border area of the plurality of
images, generating a plurality of cropped images, the second
microprocessor also including a temporal-motion-amplifier of the
plurality of cropped images that is configured to generate a
temporal variation, the second microprocessor also including a
biological vital sign generator that is operably coupled to the
temporal-motion-amplifier that is configured to generate a
biological vital sign from the temporal variation, wherein the
biological vital sign is a vital sign of the plurality of vital
signs.
17. The apparatus of claim 16 wherein a heart rate is determined
from data from the first photodiode receiver of electromagnetic
radiation, a respiration rate and a heart rate variability and a
blood pressure diastolic is determined from data from the first
photodiode receiver of electromagnetic radiation and the first
photodiode receiver of electromagnetic radiation.
18. The apparatus of claim 16 further wherein a blood pressure
systolic is determined from data from the first photodiode receiver
of electromagnetic radiation.
19. The apparatus of claim 1 where the apparatus is operable to
receive a flag or key that enables use of portions of a volatile
memory or a non-volatile memory to determine the indication of the
amount of glucose in the subject.
20. The apparatus of claim 1, wherein the microprocessor is further
configured to determine an amount of glucose in the subject when
the amount of oxygen in the subject indicates a resting period of a
heartbeat from an indication of a ratio of electromagnetic
radiation received at the 640-680 nm frequency range in comparison
to electromagnetic radiation received at the 920-960 nm frequency
range.
Description
RELATED APPLICATION
[0001] This application is a continuation of, and claims the
benefit and priority of U.S. Original patent application Ser. No.
15/985,672 filed 21 MAY 2018.
FIELD
[0002] 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
[0003] 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
[0004] 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.
[0005] In another aspect, an apparatus including a microprocessor,
the apparatus further including a physiological light monitoring
subsystem operably coupled to the microprocessor, the physiological
light monitoring subsystem including a source-detector assembly
having a first flexible side and a second flexible side, and the
apparatus further including a hard structure surrounding a portion
of the physiological light monitoring subsystem, the first flexible
side having three transmitters of electromagnetic radiation
frequencies in ranges of 375-415 nm, 640-680 nm and 920-960 nm
frequencies 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, the
source-detector assembly also having a first photodiode receiver of
electromagnetic radiation in the 350-1100 nm range to measure an
amount of electromagnetic radiation that is absorbed by the
subject, the microprocessor configured to determine an indication
of an amount of oxygen in the subject calculated from a ratio of
electromagnetic radiation received at a 640-680 nm frequency range
in comparison to electromagnetic radiation received at a 920-960 nm
frequency range, the microprocessor configured to determine an
indication of an amount of glucose in the subject calculated from a
ratio of electromagnetic radiation received at a 375-415 nm
frequency range in comparison to electromagnetic radiation received
at the 920-960 nm frequency range, the subject being positioned
between the first flexible side and the second flexible side.
[0006] 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
[0007] 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;
[0008] 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;
[0009] 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;
[0010] 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;
[0011] 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;
[0012] 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;
[0013] 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;
[0014] FIG. 8 is an isometric diagram of MVS finger cuffs in FIG.
1-FIG. 7, according to an implementation;
[0015] FIG. 9 is an exploded isometric diagram of the MVS finger
cuff in FIG. 1-FIG. 8, according to an implementation;
[0016] FIG. 10 is an exploded isometric diagram of a MVS finger
cuff in FIG. 1-FIG. 9, according to an implementation;
[0017] FIG. 11 is an exploded isometric diagram of the MVS finger
cuff in FIG. 1-FIGS. 2 and 6-FIG. 7;
[0018] FIG. 12 is a cross section diagram of a MVS finger cuff
accessory, according to an implementation;
[0019] FIG. 13 is an isometric diagram of a mechanical design of a
MVS finger cuff accessory, according to an implementation;
[0020] 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;
[0021] FIG. 15 is block diagram of a MVS finger cuff accessory with
the topskin removed to view the interior components, according to
an implementation;
[0022] FIG. 16 is an exploded isometric diagram of a MVS finger
cuff accessory, according to an implementation;
[0023] FIG. 17 is a block diagram of a MVS finger cuff smartphone
system, according to an implementation;
[0024] FIG. 18 is a block diagram of a front end of a MVS finger
cuff accessory, according to an implementation;
[0025] FIG. 19-FIG. 25 are views of a MVS finger clip that reads
physiological light signals and other vital signs, but not blood
pressure, according to implementations;
[0026] FIG. 26 is a block diagram of a MVS smartphone, according to
an implementation;
[0027] FIG. 27 is a block diagram of a MVS smartphone, according to
an implementation;
[0028] FIG. 28 is a data flow diagram of a MVS smartphone,
according to an implementation;
[0029] FIG. 29 is a block diagram of a MVS smartphone system,
according to an implementation;
[0030] FIG. 30 is a block diagram of a MVS smartphone system,
according to an implementation;
[0031] FIG. 31 is a block diagram of a MVS smartphone system,
according to an implementation;
[0032] FIG. 32 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. 33 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. 34 is a block diagram of an apparatus to estimate a
body core temperature from a temperature sensed by an infrared
sensor, according to an implementation;
[0035] FIG. 35-FIG. 36 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;
[0036] FIG. 37 is a block diagram of a digital infrared sensor,
according to an implementation.
[0037] FIG. 38 is a block diagram of a communication system,
according to an implementation;
[0038] FIG. 39 is a block diagram of an apparatus to generate a
predictive analysis of vital signs, according to an
implementation;
[0039] FIG. 40 is a flowchart of a method of motion amplification
from which to generate and communicate biological vital signs,
according to an implementation;
[0040] FIG. 41 is a block diagram of a system of interoperation
device manager, according to an implementation;
[0041] FIG. 42 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;
[0042] FIG. 43 is a flowchart of a method to perform real time
quality check on finger cuff data, according to an
implementation;
[0043] FIG. 44 is a block diagram of a method of MVS detection and
communication method, according to an implementation;
[0044] FIG. 45 is a display screen of the MVS smartphone showing
results of successful MVS measurements, according to an
implementation; and
[0045] FIG. 46 is a display screen of the MVS smartphone showing
history of successful MVS measurements, according to an
implementation.
DETAILED DESCRIPTION
[0046] 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.
[0047] 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-FIG. 11. In the third section, implementations of apparatus
of MVS finger cuff accessories are described in FIG. 12-FIG. 18. In
the fourth section, implementations of apparatus of MVS finger
clips are described in FIG. 19-FIG. 25. In the fifth section,
implementations of MVS smartphones are described in FIG. 26-FIG.
28. In the sixth section, implementations of MVS smartphone systems
are described in FIG. 29-FIG. 31. In the seventh section,
implementations of MVS devices are described in FIG. 32-FIG. 33. In
the eighth section, implementations of vital-sign components are
described in FIG. 34-FIG. 40. In the ninth section, implementations
of interoperability device manager components of an EMR System are
described in FIG. 41-FIG. 42. In the tenth section, methods of MVS
detection and communication are described in FIG. 43-FIG. 44. In
the eleventh section, implementations of displays of MVS
smartphones are described in FIG. 45-FIG. 46. Finally, in the
twelfth section a conclusion of the detailed description is
provided.
1. Overview
[0048] 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.
[0049] 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.
[0050] 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.
[0051] 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.
[0052] 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.
[0053] 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.
[0054] 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 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
[0055] Furthermore, the devices in FIG. 1-FIG. 34 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##
[0056] where Y={660 [nm], 395 [nm]}
[0057] 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 methmoglobin ( 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##
[0058] 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
[0059] FIG. 1-FIG. 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 FIG. 1-FIG. 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.
[0060] 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.
[0061] 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.
[0062] In FIG. 1-FIG. 37, only transmissive/transmissive or
reflective/reflective measurements are performed. In FIG. 1-FIG.
25, 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. 1 and FIG. 4-FIG. 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.
[0063] 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.
[0064] 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.
[0065] A microprocessor of a printed circuit board 106 or a
microprocessor that is mounted on a printed circuit board in FIG.
18-FIG. 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.
[0066] 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.
[0067] 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.
[0068] 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.
[0069] The microprocessor of the printed circuit board 206 or a
microprocessor that is mounted on a printed circuit board in FIGS.
2 and 8-FIG. 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.
[0070] 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.
[0071] 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.
[0072] The microprocessor of the printed circuit board 306 or a
microprocessor that is mounted on a printed circuit board in FIGS.
3 and 8-FIG. 37 determines reflective SpO2 by dividing the amount
of reflective ER at 660 nm and by the amount of reflective ER at
940 nm.
[0073] 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.
[0074] 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.
[0075] The microprocessor of the printed circuit board 406 or a
microprocessor that is mounted on a printed circuit board in FIG. 4
and FIG. 8-FIG. 37 determines reflective glucose by dividing the
amount of reflective ER at 395 nm by the amount of reflective ER at
940 nm.
[0076] 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.
[0077] 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.
[0078] The microprocessor of the printed circuit board or a
microprocessor that is mounted on a printed circuit board in FIG. 5
and FIG. 8-FIG. 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.
[0079] 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.
[0080] 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.
[0081] 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.
[0082] The microprocessor of the printed circuit board 606 or a
microprocessor that is mounted on a printed circuit board in FIG. 6
and FIG. 8-FIG. 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.
[0083] 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.
[0084] 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.
[0085] The microprocessor of the printed circuit board 706 or a
microprocessor that is mounted on a printed circuit board in FIG. 7
and FIG. 8-FIG. 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.
[0086] FIG. 8 is an isometric diagram of a MVS finger cuff 800,
according to an implementation.
[0087] FIG. 9 is an exploded isometric diagram of the MVS finger
cuff 800, according to an implementation.
[0088] 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.
[0089] In FIG. 8-FIG. 10, MVS finger cuff 800 includes a slide
travel 122 that slidably mounts the MVS finger cuffs in FIG. 1-FIG.
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.
[0090] FIG. 11 is an exploded isometric diagram of the MVS finger
cuff 1100 in FIG. 1-FIG. 2 and FIG. 6-FIG. 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
[0091] 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 FIG. 1-FIG. 7, FIG.
34-FIG. 36, FIG. 39-FIG. 40 and/or FIG. 43-FIG. 44, and 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.
[0092] In some implementations, the MVSFCA 1200 operably couples to
a MVS smartphone via direct connect charging contacts 1726 of the
MVS finger cuff smartphone system in FIG. 17 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 3003 in
FIG. 30 or the direct connect charging contacts 1726 of the MVS
finger cuff accessory in FIG. 17 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.
[0093] 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 2600 in FIG. 26, MVS smartphone 2700 in FIG.
27, MVS smartphone 2800 in FIG. 28, MVS smartphone 2904 in FIG. 29,
MVS smartphone 3003 in FIG. 30 and MVS smartphone 3102 in FIG. 31.
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.
[0094] 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.
[0095] 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.
[0096] 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 2904 in FIG. 29, MVS smartphone
3003 in FIG. 30, MVS smartphone 2600 in FIG. 26 and MVS smartphone
3102 in FIG. 31) via the direct connect charging contacts 1726 of
the MVS finger cuff smartphone system in FIG. 3100 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 1726 of the MVS finger cuff smartphone system in FIG. 31
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.
[0097] The MVSFCA 1200 includes an air pump 1402 that is operably
coupled to an air line 1404, a pressure sensor 1406 and a valve
1408, 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.
[0098] FIG. 17 is a block diagram of a multi-vital-sign finger cuff
accessory (MVSFCA) 1700, according to an implementation. MVSFCA
1700 is one implementation of MVSFCA 2902 in FIG. 29, MVSFCA 1700
is one implementation of MVSFCA 3002 in FIG. 30 and MVSFCA 1700 is
one implementation of MVSFCA 3104 in FIG. 31. The MVSFCA 1700
captures, stores and exports raw data from all supported sensors in
the system. MVSFCA 1700 supports a variety measurement methods and
techniques. The MVSFCA 1700 can be used in a clinical setting for
the collection of human vital signs.
[0099] A microprocessor 1702 controls and receives data from a
multi-vital-sign finger cuff 1704 (such as 100, 200, 300, 400, 500,
600 or 700), a pneumatic engine 1706, an infrared finger
temperature sensor 1708, ambient temperature sensor 1710, a
proximity sensor 1712 and another sensor 1714. In some
implementations the microprocessor 1702 is an advanced reduced
instruction set processor.
[0100] The MVS finger cuff 1704 is affixed into the MVSFCA 1700,
rather than the replaceable, detachable and removable MVS finger
cuff 2908 in FIG. 29. The MVS finger cuff 1704 includes a PLM
subsystem (such as 124, 224, 324, 424, 524, 624 or 724) and at
least one mDLS sensor. The MVS finger cuff 1704 is powered via an
air line (e.g. 1404 in FIG. 14) by the pneumatic engine 1706 that
provides air pressure to inflate the cuff bladder of the MVS finger
cuff 1704 and the that provides control signal to deflate the cuff
bladder of the MVS finger cuff 1704.
[0101] In some implementations, a body surface temperature of a
human is also sensed by the infrared finger temperature sensor 1708
that is integrated into the MVSFCA 1700 in which the body surface
temperature is collected and managed by the MVSFCA 1700.
[0102] In some implementations, a single stage measurement process
is required to measure all vital signs in one operation by the
MVSFCA 1700 by the replaceable, detachable and removable MVS finger
cuff 2908 or the MVS finger cuff 1704 or the infrared finger
temperature sensor 1708. However, in some implementations, a two
stage measurement process is performed in which the MVSFCA 1700
measures some vital signs through the replaceable, detachable and
removable MVS finger cuff 2908 or the MVS finger cuff 1704; and in
the second stage, the body surface temperature is measured through
an infrared finger temperature sensor 1708 in the MVS Smartphone
device 3003.
[0103] The MVS smartphone 3003, when connected to a wireless
Bluetooth.RTM. communication component 1718 of the MVSFCA 1700 via
a wireless Bluetooth.RTM. communication component 3014, is a slave
to the MVSFCA 1700. In other implementations, Zigbee.RTM. or
Z-Wave.RTM. can be used instead of Bluetooth.RTM.. The MVS
Smartphone 3003 reports status, measurement process, and
measurements to the user via the MVSFCA 1700.
[0104] In some implementations, the measurement process performed
by the MVSFCA 1700 is controlled and guided from the MVS Smartphone
3003 via the GUI on the MVS Smartphone 3003. The measurements are
sequenced and configured to minimize time required to complete all
measurements. In some implementations, the MVSFCA 1700 calculates
the secondary measurements of heart rate variability and blood
flow. The MVSFCA 1700 commands and controls the MVS Smartphone 3003
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
3003 communicates with the MVSFCA 1700, which could also be
concurrent.
[0105] MVSFCA 1700 includes a USB port 1718 that is operably
coupled to the microprocessor 1702 for interface with slave devices
only, such as the MVS Smartphone 3003, to perform the following
functions: recharge internal rechargeable batteries 1722, export
sensor data sets to a windows based computer system, firmware
update of the MVSFCA 1700 via an application to control and manage
the firmware update of the MVSFCA 1700 and configuration update of
the MVSFCA 1700.
[0106] In some implementation recharging the internal rechargeable
batteries 1722 via the USB port 1718 is controlled by a battery
power management module 1724. The battery power management module
1724 receives power from a direct connect charging contact(s) 1726
and/or a wireless power subsystem 1728 that receives power from a
RX/TX charging coil 1730. The internal rechargeable batteries 1722
of the MVSFCA 1700 can be recharged when the MVSFCA 1700 is
powered-off but while connected to USB port 1720 or DC input via
the direct connect charging contacts 1726. In some implementations,
the MVSFCA 1700 can recharge the MVS Smartphone 3003 from its
internal power source over a wireless charging connection. In some
implementations, the internal rechargeable batteries 1722 provide
sufficient operational life of the MVSFCA 1700 on a single charge
to perform at least 2 full days of measurements before recharging
of the internal rechargeable batteries 1722 of the MVSFCA 1700 is
required. In some implementations, system voltage rails 1732 are
operably coupled to the battery power management module 1724.
[0107] In some implementations, the MVSFCA 1700 includes an
internal non-volatile, non-user removable, data storage device 1734
for up to 2 full days of human raw measurement data sets. In some
implementations, the MVSFCA 1700 includes a Serial Peripheral
Interface (SPI) 1736 that is configured to connect to an eternal
flash storage system 1738.
[0108] In some implementations, the MVSFCA 1700 includes a Mobile
Industry Processor Interface (MIPI) 1740 that is operably connected
to the microprocessor 1702 and a display screen 1742. The
microprocessor 1702 is also operably coupled to the visual
indicators 1744.
[0109] The MVSFCA 1700 also includes a Wi-Fi.RTM. communication
module 1746 for communications via Wi-Fi.RTM. communication
frequencies and the MVSFCA 1700 also includes an enterprise
security module 1748 a cellular communication module 1750 for
communications via cell phone communication frequencies. The
Wi-Fi.RTM. communication module 1746 and the cellular communication
module 1750 are operably coupled to an antenna 1752 that is located
with a case/housing of the MVSFCA 1700.
[0110] The MVSFCA 1700 also includes an audio sub-system 1754 that
controls at one or more speakers 1756 to enunciate information to
an operator or patient. In some implementations, the microprocessor
1702 also controls a haptic motor 1758 through the audio sub-system
1754. User controls 1760 also control the haptic motor 1758. A
pulse-width modulator 1762 that is operably coupled to a
general-purpose input/output (GPIO) 1764 (that is operably coupled
to the microprocessor 1702) provides control to the haptic motor
1758.
[0111] The MVSFCA 1700 is hand held and portable. The MVSFCA 1700
includes non-slip/slide exterior surface material.
[0112] In some further implementations the MVSFCA 1700 in FIG. 17
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.
[0113] 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.
[0114] FIG. 18 is a block diagram of a front end of a
multi-vital-sign (MVS) finger cuff accessory 1800, according to an
implementation. The front end of a MVS finger cuff 1800 is one
implementation of a portion of a MVS finger cuff 2908 in FIG. 29.
The front end of a MVS finger cuff 1800 captures, stores and
exports raw data from all supported sensors in the system. The
front end of a MVS finger cuff 1800 supports a variety measurement
methods and techniques. The front end of a MVS finger cuff 1800 can
be used in a clinical setting for the collection of human vital
signs.
[0115] The front end of a MVS finger cuff 1800 includes a front-end
sensor electronic interface 1802 that is mechanically coupled to a
front-end subject physical interface 1804. The front-end sensor
electronic interface 1802 includes a PLM subsystem 1806 that is
electrically coupled to a multiplexer 1808 and to a PLM controller
1810. The front-end sensor electronic interface 1802 includes a
mDLS sensor 1812 that is electrically coupled to a multiplexer 1814
which is coupled to a mDLS controller 1816. The front-end sensor
electronic interface 1802 includes a mDLS sensor 1818 that is
electrically coupled to a multiplexer 1820 and mDLS controller
1822. The front-end sensor electronic interface 1802 includes an
ambient air temperature sensor 1710. The front-end sensor
electronic interface 1802 includes a 3-axis accelerator 1824.
[0116] The PLM controller 1810 is electrically coupled to a
controller 1826 through a Serial Peripheral Interface (SPI) 1828.
The mDLS controller 1816 is electrically coupled to the controller
1826 through a SPI 1830. The mDLS sensor 1818 is electrically
coupled to the controller 1826 through a SPI 1832. The ambient air
temperature sensor 1710 is electrically coupled to the controller
1826 through a I2C interface 1834. The 3-axis accelerator 1824 is
electrically coupled to the controller 1826 through the I2C
interface 1834.
[0117] Visual indicator(s) 1744 are electrically coupled to the
controller 1826 through a general-purpose input/output (GPIO)
interface 1836. A serial port 1832 and a high speed serial port
1838 are electrically coupled to the controller 1826 and a serial
power interface 1840 is electrically coupled to the high speed
serial port 1838. A voltage regulator 1842 is electrically coupled
to the controller 1826. A sensor front-end test component is
electrically coupled to the controller 1826 through the GPIO
interface 1836.
[0118] A sensor cover 1848 is mechanically coupled to the PLM
subsystem 1806, a pressure finger cuff 1850 is mechanically coupled
to the front-end subject physical interface 1804 and a pneumatic
connector 1852 is mechanically coupled to the pressure finger cuff
1850.
4. Apparatus of Multi-Vital-Sign Finger Clip
[0119] FIG. 19-FIG. 25 are views of a multi-vital-sign (MVS) finger
clip 1900 that reads physiological light signals and other vital
signs, but not blood pressure, according to implementations.
[0120] The MVS finger clip in FIG. 19-FIG. 25 include a main body
1902 that is mechanically and electrically coupled to a
Physiological Light Monitoring (PLM) subsystem 1904. The MVS finger
clip in FIG. 19-FIG. 25 does not include a finger occlusion cuff,
such as finger occlusion cuff 104 in FIG. 1-FIG. 7. In some
implementations, the PLM subsystem 1904 includes one or more
emitters of electromagnetic radiation (ER) and one or more
detectors of ER which are discussed in greater detail below.
[0121] The main body 1902 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.
[0122] Similar to FIG. 1-FIG. 7, in FIG. 19-FIG. 25, only
transmissive/transmissive or reflective/reflective measurements are
performed. In FIG. 19-FIG. 25, 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. 19-FIG. 25, 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.
[0123] Some implementations of the MVS finger clip 1900 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 1900 includes a thermistor
or a thermocouple to measure skin surface temperature.
[0124] In accordance with implementation #1 in Table 1 that is
particularly useful for clinical applications, the multi-vital-sign
(MVS) finger clip 1900 that determines transmissive SpO2,
reflective SpO2, reflective glucose and other vital signs but not
blood pressure, according to an implementation. In MVS finger clip
1900, the PLM subsystem 1904 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 1904 at 395 nm, 660 nm and 940 nm.
The PLM subsystem 1904 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 1904 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 1900, 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.
[0125] In accordance with implementation #2 in Table 1, the
multi-vital-sign (MVS) finger clip 1900 that determines
transmissive SpO2 and other vital signs but not blood pressure,
according to an implementation. In MVS finger clip 1900, the PLM
subsystem 1904 includes an emitter in an emitter 226 of 660 nm ER
and 940 nm ER. The PLM subsystem 1904 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 1904 at 660 nm and 940 nm. The microprocessor of the
printed circuit board 2406 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.
[0126] In accordance with implementation #3 in Table 1, the
multi-vital-sign (MVS) finger clip 1900 that determines reflective
SpO2 and other vital signs but not blood pressure, according to an
implementation. In MVS finger clip 1900, the PLM subsystem 1904
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 1904 at 660 nm and 940 nm.
The PLM subsystem 1904 does not include a detector on the opposite
side of the PLM subsystem 1904 from the emitter that detects ER
that is transmitted through the subject finger that is positioned
in the PLM subsystem 1904. 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.
[0127] In accordance with implementation #4 in Table 1, the
multi-vital-sign (MVS) finger clip 1900 that determines reflective
glucose and other vital signs but not blood pressure, according to
an implementation. In MVS finger clip 1900, the PLM subsystem 1904
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 1904 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.
[0128] In accordance with implementation #5 in Table 1 that is
particularly useful for non-clinical wellness applications, the
multi-vital-sign (MVS) finger clip 1900 that determines
transmissive SpO2, reflective SpO2, reflective glucose and other
vital signs but not blood pressure, according to an implementation.
In MVS finger clip 1900, the PLM subsystem 1904 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 1904 at 395 nm, 660
nm and 940 nm. The detector in the emitter/detector is mounted on
the same side of the PLM subsystem 1904 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.
[0129] In accordance with implementation #6 in Table 1, the
multi-vital-sign (MVS) finger clip 1900 that determines
transmissive SpO2, reflective glucose and other vital signs but not
blood pressure, according to an implementation. In MVS finger clip
1900, the PLM subsystem 1904 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 1904 at 395 nm and 940 nm. The PLM
subsystem 1904 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 1904 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.
[0130] In accordance with implementation #7 in Table 1, the
multi-vital-sign (MVS) finger clip 1900 that determines
transmissive SpO2 and reflective SpO2 and other vital signs but not
blood pressure, according to an implementation. In MVS finger clip
1900, the PLM subsystem 1904 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 1904 at 660 nm and 940 nm. The PLM
subsystem 1904 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 1904 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.
[0131] In some implementations of FIG. 1-FIG. 34, 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.
[0132] In some implementations of FIG. 1-FIG. 34, 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.
[0133] In some implementations of the PLM subsystem of FIG. 1-FIG.
34, 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.
[0134] In some implementations of FIG. 1-FIG. 34, 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.
[0135] In some implementations of FIG. 1-FIG. 34, the PLM subsystem
includes a wavelength range within the 700-1300 nm wavelength
range. Oxygenated hemoglobin (HbO.sub.2) 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
[0136] FIG. 26 is a block diagram of a multi-vital-sign (MVS)
smartphone 2600, according to an implementation. The MVS smartphone
2600 includes a number of modules such as a main processor 2602
that controls the overall operation of the MVS smartphone 2600.
Communication functions, including data and voice communications,
can be performed through a communication subsystem 2604. The
communication subsystem 2604 receives messages from and sends
messages to wireless networks 2606. In other implementations of the
MVS smartphone 2600, the communication subsystem 2604 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.
[0137] The wireless link connecting the communication subsystem
2604 with the wireless network 2606 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.
[0138] The main processor 2602 also interacts with additional
subsystems such as a Random Access Memory (RAM) 2608, a flash
memory 2610, a display 2614, an auxiliary input/output (I/O)
subsystem 2616, a data port 2618, a keyboard 2620, a speaker 2622,
a microphone 2624, short-range communications subsystem 2626 and
other device subsystems 2628. The other device subsystems 2628 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 2658. In some implementations, the flash memory 2610
includes a hybrid femtocell/Wi-Fi.RTM. protocol stack 2614. The
hybrid femtocell/Wi-Fi.RTM. protocol stack 2614 supports
authentication and authorization between the MVS smartphone 2600
into a shared Wi-Fi.RTM. network and both a 3G, 4G or 5G mobile
networks.
[0139] The MVS smartphone 2600 can transmit and receive
communication signals over the wireless network 2606 after required
network registration or activation procedures have been completed.
Network access is associated with a subscriber or user of the MVS
smartphone 2600. User identification information can also be
programmed into the flash memory 2610.
[0140] The MVS smartphone 2600 is a battery-powered device and
includes a battery interface 2636 for receiving one or more
batteries 2634. In one or more implementations, the battery 2634
can be a smart battery with an embedded microprocessor. The battery
interface 2636 is coupled to a regulator 2638, which assists the
battery 2634 in providing power V+ to the MVS smartphone 2600.
Future technologies such as micro fuel cells may provide the power
to the MVS smartphone 2600.
[0141] The MVS smartphone 2600 also includes an operating system
2640 and modules 2642 to 2658 that are executed by the main
processor 2602 are typically stored in a persistent nonvolatile
medium such as the flash memory 2610, 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 2640 and the modules 2642 to 2658, such as
specific device applications, or parts thereof, may be temporarily
loaded into a volatile store such as the RAM 2608. Other modules
can also be included.
[0142] The subset of modules 2642 that control basic device
operations, including data and voice communication applications,
will normally be installed on the MVS smartphone 2600 during its
manufacture. Other modules include a message application 2644 that
can be any suitable module that allows a user of the MVS smartphone
2600 to transmit and receive electronic messages. Various
alternatives exist for the message application 2644 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 2610
of the MVS smartphone 2600 or some other suitable storage element
in the MVS smartphone 2600. In one or more implementations, some of
the sent and received messages may be stored remotely from the MVS
smartphone 2600 such as in a data store of an associated host
system with which the MVS smartphone 2600 communicates.
[0143] The modules can further include a device state module 2646,
a Personal Information Manager (PIM) 2648, and other suitable
modules (not shown). The device state module 2646 provides
persistence, i.e. the device state module 2646 ensures that
important device data is stored in persistent memory, such as the
flash memory 2610, so that the data is not lost when the MVS
smartphone 2600 is turned off or loses power.
[0144] The PIM 2648 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 2606. PIM
data items may be seamlessly integrated, synchronized, and updated
via the wireless network 2606 with the MVS smartphone 2600
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 2600 with respect to such items.
[0145] The MVS smartphone 2600 also includes a connect module 2650,
and an IT policy module 2652. The connect module 2650 implements
the communication protocols that are required for the MVS
smartphone 2600 to communicate with the wireless infrastructure and
any host system, such as an enterprise system, with which the MVS
smartphone 2600 is authorized to interface. Examples of a wireless
infrastructure and an enterprise system are given in FIGS. 26 and
63, which are described in more detail below.
[0146] The connect module 2650 includes a set of APIs that can be
integrated with the MVS smartphone 2600 to allow the MVS smartphone
2600 to use any number of services associated with the enterprise
system. The connect module 2650 allows the MVS smartphone 2600 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 2650 can be used to pass IT policy
commands from the host system to the MVS smartphone 2600. This can
be done in a wireless or wired manner. These instructions can then
be passed to the IT policy module 2652 to modify the configuration
of the MVS smartphone 2600. Alternatively, in some cases, the IT
policy update can also be done over a wired connection.
[0147] The IT policy module 2652 receives IT policy data that
encodes the IT policy. The IT policy module 2652 then ensures that
the IT policy data is authenticated by the MVS smartphone 2600. The
IT policy data can then be stored in the RAM 2608 in its native
form. After the IT policy data is stored, a global notification can
be sent by the IT policy module 2652 to all of the applications
residing on the MVS smartphone 2600. 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.
[0148] The programs 2637 can also include a
temporal-motion-amplifier 2656 and a biological vital sign
generator 2658. In some implementations, the
temporal-motion-amplifier 2656 includes a skin-pixel-identification
module, a frequency filter, a regional facial clusterial module and
a frequency filter. In some implementations, the
temporal-motion-amplifier 2656 includes a skin-pixel-identification
module, a spatial bandpass filter, a regional facial clusterial
module and a temporal bandpass filter. In some implementations, the
temporal-motion-amplifier 2656 includes a pixel-examiner, a
temporal motion determiner and a signal processor. In some
implementations, the temporal-motion-amplifier 2656 includes a skin
pixel identification module, a frequency-filter module, a
spatial-cluster module and a frequency filter module. In some
implementations, the temporal-motion-amplifier 2656 includes the
skin pixel identification module, a spatial bandpass filter module,
a spatial-cluster module and a temporal bandpass filter module. In
some implementations, the temporal-motion-amplifier 2656 includes a
pixel-examination-module, a temporal motion determiner module and a
signal processing module. Furthermore, the solid-state image
transducer 2660 captures images 2662 and the biological vital sign
generator 2658 generates the biological vital sign(s).
[0149] In some implementations, the biological vital sign generator
2658 performs the same functions as biological vital sign generator
3234 in FIG. 32 from data received from a MVSFCA in FIG. 12-FIG. 18
and FIG. 29-FIG. 31 or a finger clip in FIG. 19-FIG. 25. In some
implementations, the MVS smartphone 2600 includes no biological
vital sign generator 2658 and the determined biological vital signs
are received through the data port 2618, the communication
subsystem 2604 or the short-range communications subsystem 2626
from a MVSFCA such as the MVSFCAs in FIG. 12-FIGS. 18 and 29-FIG.
31 or the MVS finger clip in FIG. 19-FIG. 25.
[0150] The biological vital sign that is generated or received is
then displayed by display 2614 or transmitted by the communication
subsystem 2604 or the short-range communications subsystem 2626,
enunciated by the speaker 2622 or stored by the flash memory 2610.
Examples of the biological vital signs that are displayed on the
display 2614 are FIG. 45-FIG. 46.
[0151] Other types of modules can also be installed on the MVS
smartphone 2600. These modules can be third party modules, which
are added after the manufacture of the MVS smartphone 2600.
Examples of third party applications include games, calculators,
utilities, etc.
[0152] The additional applications can be loaded onto the MVS
smartphone 2600 through of the wireless network 2606, the auxiliary
I/O subsystem 2616, the data port 2618, the short-range
communications subsystem 2626, or any other suitable device
subsystem 2628. This flexibility in application installation
increases the functionality of the MVS smartphone 2600 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 2600.
[0153] The data port 2618 enables a subscriber to set preferences
through an external device or module and extends the capabilities
of the MVS smartphone 2600 by providing for information or module
downloads to the MVS smartphone 2600 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
2600 through a direct and thus reliable and trusted connection to
provide secure device communication.
[0154] The short-range communications subsystem 2626 provides for
communication between the MVS smartphone 2600 and different systems
or devices, without the use of the wireless network 2606. For
example, the short-range communications subsystem 2626 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..
[0155] 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 Mbit/s is possible. The term Enhanced
Data Rate (EDR) is used to describe .pi./4-DPSK and 8DPSK schemes,
each giving 2 and 3 Mbit/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.
[0156] 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 2604 and input to the main processor 2602.
The main processor 2602 will then process the received signal for
output to the display 2614 or alternatively to the auxiliary I/O
subsystem 2616. A subscriber may also compose data items, such as
e-mail messages, for example, using the keyboard 2620 in
conjunction with the display 2614 and possibly the auxiliary I/O
subsystem 2616. The auxiliary I/O subsystem 2616 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 2620 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 2606 through the
communication subsystem 2604.
[0157] For voice communications, the overall operation of the MVS
smartphone 2600 is substantially similar, except that the received
signals are output to the speaker 2622, and signals for
transmission are generated by the microphone 2624. Alternative
voice or audio I/O subsystems, such as a voice message recording
subsystem, can also be implemented on the MVS smartphone 2600.
Although voice or audio signal output is accomplished primarily
through the speaker 2622, the display 2614 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.
[0158] FIG. 27 is a block diagram of a MVS smartphone 2700,
according to an implementation. MVS Smartphone 2700 is one
implementation of MVS Smartphone 2904 in FIG. 29. The MVS
Smartphone 2700 includes a sensor printed circuit board (PCB) 2702.
The sensor PCB 2702 includes proximity sensors 2704, 2706 and 2708,
and temperature sensor 2710, autofocus lens 2712 in front of camera
sensor 2714 and an illumination light emitting diode (LED) 2716.
The includes proximity sensors 2704, 2706 and 2708 are operably
coupled to a first FC port 2718 of a microprocessor 2720. One
example of the microprocessor 2720 is a Qualcomm Snapdragon
microprocessor chipset. The temperature sensor 2710 is operably
coupled to a second FC port 2722 of the microprocessor 2720. 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 2714 is operably coupled to a MIPI
port 2724 of the microprocessor 2720. The MIPI standard is defined
by the MIPI Alliance, Inc. of Piscataway, N.J. The MIPI port 2724
is also operably coupled to a MIPI RGB bridge 2726, and the MIPI
RGB bridge 2726 is operably coupled to a display device 2728 such
as a TFT Color Display (2.8''). The illumination LED 2716 is
operably coupled to a pulse-width modulator (PWM) 2730 of the
microprocessor 2720. The PWM 2730 is also operably coupled to a
haptic motor 2732. The microprocessor 2720 also includes a GPIO
port 2734, the GPIO port 2734 being a general-purpose input/output
that is a generic pin on an integrated circuit or computer board
whose behavior--including whether GPIO port 2734 is an input or
output pin--is controllable by the microprocessor 2720 at run time.
The GPIO port 2734 is operably coupled to a keyboard 2736, such as
a membrane keypad (3.times. buttons). The microprocessor 2720 is
also operably coupled to an audio codec 2738 with is operably
coupled to a speaker 2740. The microprocessor 2720 also includes a
Bluetooth.RTM. communication port 2742 and a Wi-Fi.RTM.
communication port 2744, that are both capable of communicating
with a PCB antenna 2746. In other implementations, Zigbee.RTM. or
Z-Wave.RTM. can be used instead of Bluetooth.RTM.. The
microprocessor 2720 is also operably coupled to a micro SD slot
(for debugging purposes), a flash memory unit 2750, a DDR3 random
access memory unit 2752 and a micro USB port 2754 (for debugging
purposes). The micro USB port 2754 is operably coupled to voltage
rails and a battery power/management component 2758. The battery
power/management component 2758 is operably coupled to a battery
2760, which is operably coupled to a charger connector 2762.
[0159] Biological vital signs are received through the micro USB
connector 2754, the Wi-Fi.RTM. 2744 or the Bluetooth.RTM. 2742 from
a MVSFCA such as the MVSFCAs in FIG. 12-FIG. 18 and FIG. 29-FIG. 31
or the MVS finger clip in FIG. 19-FIG. 25. The biological vital
signs that are received are then displayed by display 2728 and/or
transmitted by the Wi-Fi.RTM. 2744 or the Bluetooth.RTM. 2742,
enunciated by the speaker 2740 or stored by the flash memory 2750.
Examples of the biological vital signs that are displayed on the
display 2728 are FIG. 45-FIG. 46.
[0160] FIG. 28 is a data flow diagram 2800 of the MVS smartphone
3003, according to an implementation. Data flow diagram 2800 is a
process of the MVSFCA 3002 via a graphical user interface on a LCD
display 3016 on the MVS smartphone device 3003.
[0161] In data flow diagram 2800, a main screen 2802 is displayed
by the MVS Smartphone device 3003 that provides options to exit the
application 2804, display configuration settings 2806, display data
export settings 2808 or display patient identification entry screen
2810. The configuration settings display 2806 provides options for
the configuration/management of the MVS Smartphone device 3003. In
some implementations, the data flow diagram 2800 includes low power
operation and sleep, along startup, initialization, self check and
measurement capability of the MVS Smartphone device 3003. The
display of data export settings 2808 provides options to take
individual measurement of a given vital sign. After the patient
identification entry screen 2810 or and alternatively, bar code
scanning of both operator and subject, has been completed, one or
more sensors are placed on the patient 2812, the MVS Smartphone
device 3003 verifies 2814 that signal quality from the sensors is
at or above a predetermined minimum threshold. If the verification
2814 fails 2816 as shown in FIG. 45, then the process resumes where
one or more sensors are placed on the patient 2812. If the
verification 2814 succeeds 2818 as shown in FIG. 46, then
measurement 2820 using the one or more sensors is performed and
thereafter the results of the measurements are displayed 2822 as
shown in FIG. 34 and thereafter the results of the measurements are
saved to EMR or clinical cloud 2824, and then the process continues
at the main screen 2802. The "para n done" actions the measurement
2820 are indications that the sensing of the required vital-signs
is complete. Examples of the measurements 2820 that are displayed
2822 are FIG. 45-FIG. 46.
6. Apparatus of Multi-Vital-Sign System
[0162] FIG. 29 is a block diagram of a multi-vital-sign (MVS)
smartphone system 2900, according to an implementation. The MVS
system 2900 includes two communicatively coupled devices; a
multi-vital-sign finger cuff accessory MVSFCA 2902 and a
multi-vital-sign smartphone (MVS Smartphone) 2904. The MVSFCA 2902
includes a MVS finger cuff 2908. The MVS system 2900 is one example
of the MVS apparatus 4104. In some implementations, the MVS system
2900 captures, stores and exports raw data from all supported
sensors in the MVS finger cuff 2908. MVS system 2900 provides a
flexible human vital sign measurement methodology that supports
different measurement methods and techniques. The MVS system 2900
can be used in a clinical setting or a home setting for the
collection of human vital signs. The MVSFCA 2902 can be configured
to detect blood pressure only, SpO2 only, blood glucose levels
only, heart rate only, respiration only, or any combination of
vital signs that the MVSFCA is capable of detecting. The MVS
Smartphone 2904 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.
[0163] The MVSFCA 2902 includes a pneumatic engine 2906 and a MVS
finger cuff 2908 that are operably coupled to each other through an
air line 1404 and a communication path 2910, such as a 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 2902. A cuff
bladder of the MVS finger cuff 2908 expands and contracts in
response to air pressure from the air line 1404.
[0164] Some implementations of the MVS finger cuff 2908 include a
finger occlusion cuff 2916 and a PLM subsystem 2918. The MVS finger
cuffs in FIG. 1-FIG. 7 are examples of the MVS finger cuff 2908.
The finger occlusion cuff 2916 and the PLM subsystem 2918 are shown
in greater detail in FIG. 1-FIG. 12. In some implementations, the
MVS finger cuff 2908 includes at least one miniaturized dynamic
light scattering (mDLS) sensor and the PLM subsystem 2918. The PLM
subsystems in FIG. 1-FIG. 12 are examples of the PLM subsystem
2918. PLM subsystem 2918 and the finger occlusion cuff 2916 are
operably coupled to a common board in the MVS finger cuff 2908
(such as printed circuit boards 106, 206, 306, 406, 506, 606 and
706 in FIG. 1, FIG. 2, FIG. 3, FIG. 4, FIG. 5, FIG. 6 and FIG. 7,
respectively) and the common board is operably coupled through the
communication path 2910 (such as finger sensor cable 3110 in FIG.
31) to a printed circuit board (such as printed circuit board 1214
in FIG. 12) that is in the base of MVSFCA 2902.
[0165] In some implementations, the MVS finger cuff 2908 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 2908. The PLM and mDLS
implementation of the MVS finger cuff 2908 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.
[0166] In some implementations, the MVS finger cuff 2908 is
replaceable, detachable and removable from the MVSFCA 2902. In some
implementations, the MVS finger cuff 2908 is integrated into the
MVSFCA 2902. The MVS finger cuff 290 that is replaceable,
detachable and removable from the MVSFCA 2902 is beneficial in two
ways: 1) the MVS finger cuff 2908 is replaceable in the event of
damage 2) the MVS finger cuff 2908 can be detached from the MVSFCA
2902 and then attached to a custom connector cable (pneumatic and
electrical) that allows a patient to wear the MVS finger cuff 2908
for continuous monitoring, and (3) servicing the device. The
replaceable MVS finger cuff 2908 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 2908 is translucent or transparent
to transparent to the mDLS laser wavelengths and which in some
implementations allows the position of the MVS finger cuff 2908 to
be adjusted in relation to specific parts of human anatomy for
optimal function of the sensors and comfort to the patient.
[0167] The MVSFCA 2902 and the MVS Smartphone 2904 can be operably
coupled to each other through a communication path 2912 to exchange
data and control signals and a 4 point electrical recharge
interface (I/F) line 2914 recharge from a conventional wall outlet.
In some implementations, the 4 point electrical recharge interface
(I/F) line 2914 is a 3 point electrical recharge interface (I/F)
line. The MVSFCA 2902 and the MVS Smartphone 2904 do not need to be
physically attached to each other for measurement operation by
either the MVSFCA 2902 or the MVS Smartphone 2904. In some
implementations, the MVSFCA 2902 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 2904 has at least one USB port(s) for communication with
other devices via USB, such as connected to a MVSFCA 2902 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 2904 through the Bluetooth.RTM. link 2912 from a MVSFCA
such as in FIG. 12-FIG. 18 or a MVS finger cuff in FIG. 19-FIG. 25
in FIG. 12-FIG. 18 or the MVS finger clip in FIG. 19-FIG. 25. The
biological vital signs that are received are then displayed by
display 2728 an/or transmitted by the Wi-Fi.RTM. 2744 or the
Bluetooth.RTM. 2742, enunciated by the speaker 2740 or stored by
the flash memory 2750. Examples of the biological vital signs that
are displayed on the display 2728 are FIG. 45-FIG. 46. In other
implementations, Zigbee.RTM. or Z-Wave.RTM. can be used instead of
Bluetooth.RTM..
[0168] FIG. 30 is a block diagram of a MVS smartphone system 3000,
according to an implementation. The MVS smartphone system 3000
includes three communicatively coupled devices; a MVS finger cuff
accessory (MVSFCA) 3002, a multi-vital-sign smartphone (MVS
Smartphone) 3003 and a multi-vital-sign finger cuff accessory
Recharge Station (MVSFCARS) 3004. MVSFCA 3002 is one implementation
of MVSFCA 2902 in FIG. 29. MVS Smartphone 3003 is one
implementation of MVS Smartphone 2904 in FIG. 29. MVS smartphone
system 3000, the MVSFCA 3002 and the MVS Smartphone 3003 are all
examples of the MVS apparatus 4104. The MVS Smartphone 3003
captures, stores and exports raw data from all supported sensors in
the system. More specifically, the MVS Smartphone 3003 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 3000 provides a
flexible human vital sign measurement methodology that supports
different measurement methods and techniques. The MVS smartphone
system 3000 can be used in a clinical setting for the collection of
human vital signs.
[0169] Some implementations of the MVSFCA 3002 include a MVS finger
cuff 1704 that is fixed into the MVSFCA 3002, rather than the
replaceable, detachable and removable MVS finger cuff 2908 in FIG.
29. The MVS finger cuff 1704 includes a PLM subsystem and at least
one mDLS sensor. The MVS finger cuff 1704 is powered via an air
line (e.g. 1404 in FIG. 29) by a pneumatic engine 1706 that
provides air pressure to inflate the cuff bladder of the MVS finger
cuff 1704 and the controlled release of that pressure. In some
implementations, the air line 1404 is 1/6'' (4.2 mm) in
diameter.
[0170] In some implementations, a body surface temperature of a
human is also sensed by an infrared finger temperature sensor 1708
that is integrated into the MVSFCA 3002 in which the body surface
temperature is collected and managed by the MVSFCA 3002. One
example of the pneumatic engine 1706 is the pneumatic engine
2906.
[0171] In some implementations, a single stage measurement process
is required to measure all vital signs in one operation by the MVS
Smartphone 3003 by the replaceable, detachable and removable MVS
finger cuff 2908 or the MVS finger cuff 1704 or the infrared finger
temperature sensor 1708. However, in some implementations, a two
stage measurement process is performed in which the MVSFCA 3002
measures some vital signs through the replaceable, detachable and
removable MVS finger cuff 2908 or the MVS finger cuff 1704; and in
the second stage, the body surface temperature is measured through
an infrared finger temperature sensor 1708 in the MVS Smartphone
device 3003. One implementation of the infrared finger temperature
sensor 1708 is digital infrared sensor 1312 in FIG. 37.
[0172] The MVSFCA 3002 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 3002 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
3002 to take a set of vital sign measurements of themselves. In
some implementations, the MVSFCA 3002 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
temperature (requires the other device to perform temperature
measurement). The MVSFCA 3002 is portable, light weight, hand held
and easy to use in primary and secondary modes of operation in all
operational environments.
[0173] Given the complex nature of integration into hospital
networks, in some implementations the MVSFCA 3002 does not include
site communication infrastructure, rather the collected data (vital
sign) is extracted from the MVSFCA 3002 via a USB port or by a USB
mass storage stick that is inserted into the MVSFCA 3002 or by
connecting the MVSFCA 3002 directly to a PC system as a mass
storage device itself.
[0174] The MVS smartphone 3003, when connected to a wireless
Bluetooth.RTM. communication component 1718 of the MVSFCA 3002 via
a wireless Bluetooth.RTM. communication component 3014, can be a
slave to the MVSFCA 3002. The MVS Smartphone 3003 reports status,
measurement process, and measurement measurements to the user via
the MVSFCA 3002. The MVS Smartphone 3003 provides a user input
method to the MVSFCA 3002 via a graphical user interface on a LCD
display 3016 which displays data representative of the measurement
process and status. In one implementation, the wireless
Bluetooth.RTM. communication component 1718 of the MVSFCA 3002
includes communication capability with cellular communication paths
(3G, 4G and/or 5G) and/or Wi-Fi.RTM. communication paths and the
MVSFCA 3002 is not a slave to the captures vital sign data and
transmits the vital sign data via the wireless Bluetooth.RTM.
communication component 1718 in the MVSFCA 3002 to the middle layer
4206 in FIG. 42 or the MVS Smartphone 3003 transmits the vital sign
data via the communication component 3018 of the MVS Smartphone
3003 to the bridge 4220, a Wi-Fi.RTM. access point, a cellular
communications tower, a bridge 4220 in FIG. 42. In other
implementations, Zigbee.RTM. or Z-Wave.RTM. can be used instead of
Bluetooth.RTM..
[0175] In some implementations, the MVS Smartphone 3003 provides
communications with other devices via a communication component
3018 of the MVS Smartphone 3003. The communication component 3018
has communication capability with cellular communication paths (3G,
4G and/or 5G) and/or Wi-Fi.RTM. communication paths. For example,
the MVSFCA 3002 captures vital sign data and transmits the vital
sign data via the wireless Bluetooth.RTM. communication component
1718 in the MVSFCA 3002 to the wireless Bluetooth.RTM.
communication component 3014 in the MVS Smartphone 3003, and the
MVS Smartphone 3003 transmits the vital sign data via the
communication component 3018 of the MVS Smartphone 3003 to the
middle layer 4206 in FIG. 42 or the MVS Smartphone 3003 transmits
the vital sign data via the communication component 3018 of the MVS
Smartphone 3003 to the bridge 4220, a Wi-Fi.RTM. access point, a
cellular communications tower, a bridge 4220 in FIG. 42.
[0176] In some implementations, when the MVS Smartphone 3003 is
connected to the MVSFCA 3002, the MVS Smartphone 3003 performs
human bar code scan by a bar code scanner 3020 or identification
entry as requested by MVSFCA 3002, the MVS Smartphone 3003 performs
an operator bar code scan or identification entry as requested by
MVSFCA 3002, the MVS Smartphone 3003 performs human temperature
measurement as requested by MVSFCA 3002, the MVS Smartphone 3003
displays information that is related to the MVSFCA 3002 direct
action, the MVS Smartphone 3003 starts when the MVSFCA 3002 is
started, and the MVS Smartphone 3003 is shutdown under the
direction and control of the MVSFCA 3002, and the MVS Smartphone
3003 has a self-test mode that determines the operational state of
the MVSFCA 3002 and sub systems, to ensure that the MVSFCA 3002 is
functional for the measurement. In other implementations, when the
MVS Smartphone 3003 is connected to the MVSFCA 3002, the MVS
Smartphone 3003 performs human bar code scan or identification
entry as requested by MVS Smartphone 3003, the MVS Smartphone 3003
performs an operator bar code scan or identification entry as
requested by MVS Smartphone 3003, the MVS Smartphone 3003 performs
human temperature measurement as requested by MVS Smartphone 3003
and the MVS Smartphone 3003 displays information that is related to
the MVSFCA 3002 direct action. In some implementations, the
information displayed by the MVS Smartphone 3003 includes
date/time, human identification number, human name, vitals
measurement such as blood pressure (diastolic and systolic), SpO2,
heart rate, temperature, respiratory rate, MVSFCA 3002 free memory
slots, battery status of the MVS Smartphone 3003, battery status of
the MVSFCA 3002, device status of the MVSFCA 3002, errors of the
MVS Smartphone 3003, 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 3003 and the MVSFCA
3002. In some implementations, when a body surface temperature of a
human is also sensed by an infrared sensor in the MVS smartphone
3003, the body surface temperature is collected and managed by the
MVSFCA 3002. In other implementations, when a body surface
temperature of a human is sensed by an infrared sensor in the MVS
smartphone 3003, the body surface temperature is not collected and
managed by the MVSFCA 3002.
[0177] In some implementations, the multi-vital-sign finger cuff
accessory (MVSFCA) 3002 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 1704 that includes a PLM
subsystem and two mDLS sensors, the infrared finger temperature
sensor 1708 and an ambient air temperature sensor 1710, 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 bit/sec and for
the ambient air temperature sensor is less than 1000 bps. Two mDLS
sensors are included in the MVSFCA 3002 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.
[0178] The MVS Smartphone 3003 performs concurrent two stage
measurement processes for all measurements. The measurement process
performed by the MVS Smartphone 3003 is controlled and guided from
the MVS Smartphone 3003 via the GUI on the MVSFCA 3002. The
measurements are sequenced and configured to minimize time required
to complete all measurements. In some implementations, the MVS
Smartphone 3003 calculates the secondary measurements of heart rate
variability and blood flow. The MVS Smartphone 3003 commands and
controls the MVSFCA 3002 via a wireless Bluetooth.RTM. protocol
communication path 2912 and in some further implementations, the
MVSFCA 3002 communicates to other devices through Bluetooth.RTM.
protocol communication line (not shown), in addition to the
communications with the MVS Smartphone 3003 which could also be
concurrent. in some further implementations, the MVS Smartphone
3003 communicates to other devices through Bluetooth.RTM. protocol
communication line (not shown), in addition to the communications
with the MVSFCA 3002 device, which could also be concurrent.
[0179] MVSFCA 3002 includes a USB port 1720 for interface with the
MVS Smartphone 3003 only, such as the MVS Smartphone 3003, to
perform the following functions: recharge the internal rechargeable
batteries 1722 of the MVSFCA 3002, export sensor data sets to a
windows based computer system, firmware update of the MVSFCA 3002
via an application to control and manage the firmware update of the
MVSFCA 3002 and configuration update of the MVSFCA 3002. The MVSFCA
3002 does not update the MVS Smartphone 3003 firmware. The MVSFCA
3002 also includes internal rechargeable batteries 1722 that can be
recharged via a USB port 3028, which transmits charge, and the
MVSFCA 3002 also includes an external direct DC input providing a
fast recharge. The internal batteries of the MVSFCA 3002 can be
recharged when the MVSFCA 3002 is powered-off but while connected
to USB or DC input. In some implementations, the MVSFCA 3002 can
recharge the MVS Smartphone 3003 from its internal power source
over a wireless charging connection. In some implementations, the
internal rechargeable batteries 1722 provide sufficient operational
life of the MVSFCA 3002 on a single charge to perform at least 2
days of full measurements before recharging of the internal
rechargeable batteries 1722 of the MVSFCA 3002 is required.
[0180] In some implementations, the MVSFCA 3002 includes an
internal non-volatile, non-user removable, data storage device 1734
for up to 20 human raw measurement data sets. The data storage
device 1734 can be removed by a technician when the data storage
device 1734 is determined to be faulty. A human measurement set
contains all measurement data and measurements acquired by the
MVSFCA 3002, including the temperature measurement from the MVS
Smartphone 3003. The internal memory is protected against data
corruption in the event of an abrupt power loss event. The MVSFCA
3002 and the MVS Smartphone 3003 have a human-form fit function
sensor and device industrial/mechanical design. The MVSFCA 3002
also includes anti-microbial exterior material to and an easy clean
surface for all sensor and device surfaces. The MVSFCA 3002 stores
in the data storage device 1734 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
3002 includes self-test components that determine the operational
state of the MVSFCA 3002 and sub systems, to ensure that the MVSFCA
3002 is functional for measurement. The MVSFCA 3002 includes a
clock function for date and time. In some implementations. The date
and time of the MVSFCA 3002 is be updated from the MVS Smartphone
3003. In some implementations, the MVSFCA 3002 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 3003 via on screen information of the MVS Smartphone
3003. In some implementations, the MVSFCA 3002 includes visual
indicators 1744 such as a fatal fault indicator that indicates
device has failed and will not power up, a device fault indicator
(that indicates the MVSFCA 3002 has a fault that would affect the
measurement function), battery charging status indicator, battery
charged status indicator, a battery fault status indicator.
[0181] The components (e.g. 1704, 1706, 1708, 1710, 1718, 1720,
1722, 3028, 1734 and 1744) in the MVSFCA 3002 are controlled by a
control process and signal processing component 3030. The control
process and signal processing component can implemented by a
microprocessor or by a FPGA.
[0182] The multi-vital-sign finger cuff accessory Recharge Station
(MVSFCARS) 3004, provides electrical power to recharge the MVSFCA
3002. The MVSFCARS 3004 can provide electrical power to recharge
the batteries of the MVSFCA 3002 either via a physical wired
connection or via a wireless charge 3034. In some implementations,
the MVSFCARS 3004 does not provide electrical power to the MVSFCA
3002 because the MVSFCA 3002 includes internal rechargeable
batteries 1722 that can be recharged via either USB port 3028 or a
DC input.
[0183] MVS Smartphone 3003 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.
[0184] The MVSFCA 3002 is hand held and portable. The MVSFCA 3002
includes non-slip/slide exterior surface material.
[0185] Vital signs are received through the wireless Bluetooth.RTM.
communication component 3014 from a MVSFCA such as the MVSFCAs in
FIG. 12-FIG. 18 and FIG. 29-FIG. 31 or the MVS finger clip in FIG.
19-FIG. 25. The vital signs that are received are then displayed by
LCD display 3016 and/or transmitted by the communication component
3018, enunciated by a speaker or stored by a flash memory. Examples
of the biological vital signs that are displayed on the display
3016 are FIG. 45-FIG. 46.
[0186] FIG. 31 is a block diagram of a MVS smartphone system 3100,
according to an implementation. The MVS smartphone system 3100
includes two communicatively coupled devices; a MVS smartphone 3102
and a MVS finger cuff accessory(MVSFCA) 3104. MVS smartphone 3102
is one implementation of MVS smartphone 2904 in FIG. 29 and one
implementation of MVS smartphone 3003 in FIG. 30. MVSFCA 3104 is
one implementation of MVSFCA 2902 in FIG. 29 and one implementation
of MVSFCA 3002 in FIG. 30. The MVS smartphone system 3100, the
MVSFCA 3104 and the MVS smartphone 3102 are all examples of the MVS
apparatus 4104. The MVS smartphone 3102 captures, stores and
exports raw data from all supported sensors in the MVS smartphone
system 3100. More specifically, the MVS smartphone 3102 extracts
the vital signs through the MVSFCA 3104, 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 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.
[0187] The MVSFCA 3104 include a MVS finger cuff 3106 (such as MVS
finger cuff 1704 in FIG. 17) that is fixed into the MVSFCA 3104,
rather than the replaceable, detachable and removable MVS finger
cuff 2908 in FIG. 29. MVS finger cuff 3106 is electrically coupled
to the MVSFCA 3104 via a serial line 3108. The MVS finger cuff 3106
includes a PLM subsystem 1806 and at least one mDLS sensor 1812
and/or 1818. The MVS finger cuff 3106 is powered by and connected
to a finger sensor cable (FSC) 3110 that includes an air line (e.g.
1404 in FIG. 14), the air line being powered by a pneumatic engine
1706 in the MVSFCA 3104 that provides air pressure to inflate a
cuff bladder of the pressure finger cuff 1850 and the controlled
release of that air pressure.
[0188] In some implementations, a body surface temperature of a
human is also sensed by an infrared finger temperature sensor 1708
that is integrated into the MVS finger cuff 3106 in which the body
surface temperature is collected and managed by the MVS finger cuff
3106.
[0189] In some implementations, a single stage measurement process
is required to measure all vital signs in one operation by the MVS
smartphone 3102, the MVSFCA 3104 and the MVS finger cuff 3106
working cooperatively. However, in some implementations, a two
stage measurement process is performed in which the MVSFCA 3104
measures some vital signs through the MVS finger cuff 3106; and in
the second stage, the body surface temperature is measured through
an infrared finger temperature sensor 1708 in the MVS smartphone
3102. One implementation of the infrared finger temperature sensor
1708 is digital infrared sensor 1312 in FIG. 37.
[0190] The MVSFCA 3104 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 3104 through the MVS smartphone 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 3104 through the MVS smartphone
3102 to take a set of vital sign measurements of themselves. In
some implementations, the MVSFCA 3104 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
temperature (requires the MVS smartphone 3102 to perform
temperature measurement). The MVSFCA 3104 is portable, light
weight, hand held and easy to use in primary and secondary modes of
operation in all operational environments.
[0191] Given the complex nature of integration into hospital
networks, in some implementations, in some implementations the
MVSFCA 3104 does not include site communication infrastructure,
rather the collected data (vital sign) is extracted from the MVSFCA
3104 via a USB port 3028 or by a USB mass storage stick that is
inserted into the MVSFCA 3104 or by connecting the MVSFCA 3104
directly to a PC system as a mass storage device itself.
[0192] The MVSFCA 3104, when connected to a wireless Bluetooth.RTM.
communication component 3014 of the MVS smartphone 3102 via a
wireless Bluetooth.RTM. communication component 1718, can be a
slave to the MVS smartphone 3102. The MVSFCA 3104 reports status,
measurement process, and measurement measurements to the user via
the MVS smartphone 3102. The MVS smartphone 3102 provides a user
input method to the MVSFCA 3104 via a graphical user interface on a
LCD display 3016 which displays data representative of the
measurement process and status. In one implementation, the wireless
Bluetooth.RTM. communication component 3014 of the MVS smartphone
3102 includes communication capability with cellular communication
paths (3G, 4G and/or 5G) and/or Wi-Fi.RTM. communication paths, the
MVS smartphone 3102 is not a slave to the MVSFCA 3104 and the
MVSFCA 3104 captures vital sign data and transmits the vital sign
data via the wireless Bluetooth.RTM. communication component 3014
in the MVS smartphone 3102 and the MVS smartphone 3102 transmits
the vital sign data to the middle layer 4206 in FIG. 42 or the
MVSFCA 3104 transmits the vital sign data via the wireless
Bluetooth.RTM. communication component 1718 of the MVSFCA 3104 to
the bridge 4220, a Wi-Fi.RTM. access point, a cellular
communications tower or a bridge 4220 in FIG. 42. In other
implementations, Zigbee.RTM. or Z-Wave.RTM. can be used instead of
Bluetooth.RTM..
[0193] In some implementations, the MVS smartphone 3102 provides
communications with other devices via a communication component
3018 of the MVS smartphone 3102. The communication component 3018
has communication capability with cellular communication paths (3G,
4G and/or 5G) and/or Wi-Fi.RTM. communication paths. For example,
the MVSFCA 3104 captures vital sign data and transmits the vital
sign data via the wireless Bluetooth.RTM. communication component
1718 in the MVSFCA 3104 to the wireless Bluetooth.RTM.
communication component 3014 in the MVS smartphone 3102, and the
MVS smartphone 3102 transmits the vital sign data via the
communication component 3018 of the MVS smartphone 3102 to the
middle layer 4206 in FIG. 42 or the MVS smartphone 3102 transmits
the vital sign data via the communication component 3018 of the MVS
smartphone 3102 to the bridge 4220, a Wi-Fi.RTM. access point, a
cellular communications tower or a bridge 4220 in FIG. 42.
[0194] In some implementations, when the MVS smartphone 3102 is
connected to the MVSFCA 3104, the MVS smartphone 3102 performs
human bar code scan by a bar code scanner 3020 or identification
entry as requested by MVSFCA 3104, the MVS smartphone 3102 performs
an operator bar code scan or identification entry as requested by
MVSFCA 3104, the MVS smartphone 3102 displays information that is
related to the MVSFCA 3104, the MVS smartphone 3102 starts when the
MVSFCA 3104 is started, and the MVS smartphone 3102 is shutdown
under the direction and control of the MVSFCA 3104, and the MVS
smartphone 3102 has a self-test mode that determines the
operational state of the MVSFCA 3104 and sub systems, to ensure
that the MVSFCA 3104 is functional for the measurement. In other
implementations,
[0195] In some implementations, when the MVS smartphone 3102 is
connected to the MVSFCA 3104, the MVS smartphone 3102 performs
human bar code scan by a bar code scanner 3020 or identification
entry as requested by the MVSFCA 3104, the MVS smartphone 3102
performs an operator bar code scan or identification entry as
requested by the MVSFCA 3104, and the MVS smartphone 3102 displays
information that is related to the MVSFCA 3104. In some
implementations, the information displayed by the MVS smartphone
3102 includes date/time, human identification number, human name,
vitals measurement such as blood pressure (diastolic and systolic),
SpO2, heart rate, temperature, respiratory rate, MVSFCA 3104 free
memory slots, battery status of the MVS smartphone 3102, battery
status of the MVSFCA 3104, device status of the MVSFCA 3104, errors
of the MVS smartphone 3102, 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 3102
and the MVSFCA 3104. In some implementations, when a body surface
temperature of a human is also sensed by an infrared sensor in the
MVS smartphone 3102, the body surface temperature is collected and
managed by the MVSFCA 3104. In other implementations, when a body
surface temperature of a human is sensed by an infrared sensor in
the MVS smartphone 3102, the body surface temperature is not
collected and managed by the MVSFCA 3104.
[0196] In some implementations, the MVS finger cuff accessory
(MVSFCA) 3104 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 1850, the PLM subsystem 1806 and two mDLS
sensors 1812 and 1818, the infrared finger temperature sensor 1708
and an ambient air temperature sensor 1710, and in some further
implementations, non-disposable sensors for other human vital sign
measurements. In some implementations, data sample rates for the
PLM subsystem 1806 is 2.times.200 Hz.times.24 bit=9600 bits/sec,
for each of the mDLS sensors 1812 and 1818 is 31 kHz.times.24
bit=1,572,864 bit/sec and for the ambient air temperature sensor is
less than 1000 bps. Two mDLS sensors 1812 and 1818 are included in
the MVS finger cuff 3106 to ensure that one or both sensors 1812
and 1818 delivers a good quality signal, thus increasing the
probability of obtaining a good signal from at least one of the
mDLS sensors 1812 and 1818.
[0197] The MVS smartphone 3102 performs concurrent two stage
measurement processes for all measurements. The measurement process
performed by the MVSFCA 3104 is controlled and guided from the MVS
smartphone 3102 via the GUI on the MVSFCA 3104. The measurements
are sequenced and configured to minimize time required to complete
all measurements. In some implementations, the MVS smartphone 3102
calculates the secondary measurements of heart rate variability and
blood flow from signals from the PLM subsystem 1806. The MVS
smartphone 3102 commands and controls the MVSFCA 3104 via a
wireless Bluetooth.RTM. protocol communication line and in some
further implementations, the MVSFCA 3104 communicates to other
devices through Bluetooth.RTM. protocol communication line (not
shown), in addition to the communications with the MVS smartphone
3102, which could also be concurrent. In some further
implementations, the MVS smartphone 3102 communicates to other
devices through Bluetooth.RTM. protocol communication line (not
shown), in addition to the communications with the MVSFCA 3104
device, which could also be concurrent.
[0198] MVSFCA 3104 includes USB port 3028 to perform the following
functions: recharge the internal rechargeable batteries 1722 of the
MVSFCA 3104, export sensor data sets to a windows based computer
system 3114, firmware update of the MVSFCA 3104 via an application
to control and manage the firmware update of the MVSFCA 3104 and
configuration update of the MVSFCA 3104. The MVSFCA 3104 does not
update the MVS smartphone 3102 firmware. The internal rechargeable
batteries 1722 can be recharged via a USB port 3028, which provides
charge, and the MVSFCA 3104 can also include an external direct DC
input providing a fast recharge. The internal batteries 1722 of the
MVSFCA 3104 can be recharged when the MVSFCA 3104 is powered-off
but while connected to USB or DC input. In some implementations,
the MVSFCA 3104 can recharge the MVS smartphone 3102 from its
internal power source over a wireless charging connection. In some
implementations, the internal rechargeable batteries 1722 provide
sufficient operational life of the MVSFCA 3104 on a single charge
to perform at least 2 days of full measurements before recharging
of the internal rechargeable batteries 1722 of the MVSFCA 3104 is
required.
[0199] In some implementations, the MVSFCA 3104 includes an
internal non-volatile, non-user removable, data storage device 1734
for up to 20 human raw measurement data sets. The data storage
device 1734 can be removed by a technician when the data storage
device 1734 is determined to be faulty. A human measurement set
contains all measurement data and measurements acquired by the
MVSFCA 3104, including the temperature measurement from the MVS
smartphone 3102. The internal memory is protected against data
corruption in the event of an abrupt power loss event. The MVSFCA
3104 and the MVS finger cuff 3106 have a human-form fit function.
The MVSFCA 3104 also includes anti-microbial exterior material to
and an easy clean surface for all sensor and device surfaces. The
MVSFCA 3104 stores in the data storage device 1734 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 3104 includes self-test components that
determine the operational state of the MVSFCA 3104 and sub systems,
to ensure that the MVSFCA 3104 is functional for measurement. The
MVSFCA 3104 includes a clock function for date and time. In some
implementations. The date and time of the MVSFCA 3104 is be updated
from the MVS smartphone 3102. In some implementations, the MVSFCA
3104 includes user input controls, such as a power on/off switch
(start/stop), an emergency stop control to bring the pressure
finger cuff 1850 to a deflated condition. In some implementations,
all other input is supported via the MVS smartphone 3102 via on
screen information of the MVS smartphone 3102. In some
implementations, the MVSFCA 3104 includes visual indicators 1744
such as a fatal fault indicator that indicates device has failed
and will not power up, a device fault indicator (that indicates the
MVSFCA 3104 has a fault that would affect the measurement
function), battery charging status indicator, battery charged
status indicator or a battery fault status indicator.
[0200] The components (e.g. 1706, 1718, 1722, 3028, 1734 and 1744)
in the MVSFCA 3104 are controlled by a control process and signal
processing component 3030. The control process and signal
processing component 3030 be can implemented in a microprocessor or
by a FPGA.
[0201] The external USB charger 3112 provides electrical power to
recharge the MVSFCA 3104. The external USB charger 3112 can provide
electrical power to recharge the batteries of the MVSFCA 3104
either via a physical wired connection or via a wireless charger.
In some implementations, the external USB charger 3112 does not
provide electrical power to the MVSFCA 3104 because the MVSFCA 3104
includes internal rechargeable batteries 1722 that can be recharged
via either USB port 3028 or a DC input. The MVSFCA 3104 is hand
held and portable. The MVSFCA 3104 includes non-slip/slide exterior
surface material.
[0202] Vital signs are received through the wireless Bluetooth.RTM.
communication component 3014 from a MVSFCA such as the MVSFCAs in
FIG. 12-FIG. 18 and FIG. 29-FIG. 31 or the MVS finger clip in FIG.
21-FIG. 25. The vital signs that are received are then displayed by
display 2728 an/or transmitted by the communication component 3018,
enunciated by a speaker or stored by flash memory. Examples of the
vital signs that are displayed on the display 2728 are FIG. 45-FIG.
46.
[0203] MVS Smartphones 2600 in FIG. 26, MVS smartphone 2700 in FIG.
27, MVS smartphone 2800 in FIG. 28, MVS smartphone 2904 in FIG. 29,
MVS smartphone 3003 in FIG. 30, and MVS smartphone 3102 in FIG. 31
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, the downloaded software
is a flag or key that enables use of portions of the volatile
memory or the non-volatile memory to process a specific vital sign,
such as glucose blood levels. 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
[0204] FIG. 32 is a block diagram of a MVS device 3200 that
includes a digital infrared sensor, a biological vital sign
generator and a temporal motion amplifier, according to an
implementation. MVS device 3200 is an apparatus to measure body
core temperature and other biological vital signs. The MVS device
3200 is one example of the MVS apparatus 4104.
[0205] The MVS device 3200 includes a microprocessor 3202. The MVS
device 3200 includes a battery 3204, in some implementations a
single button 3206, and a digital infrared sensor 3208 that is
operably coupled to the microprocessor 3202. The digital infrared
sensor 3208 includes digital ports 3210 that provide only digital
readout signal 3212. One example of the digital infrared sensor
3208 is digital infrared sensor 1312 in FIG. 37. In some
implementations the MVS device 3200 includes a display device 3218
that is operably coupled to the microprocessor 3202. In some
implementations, the display device 3218 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 3218 are activated
(remain lit) for about 5 seconds after the single button 3206 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 3218 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 3218 can be used for treatment decisions.
[0206] The microprocessor 3202 is configured to receive from the
digital ports 3210 that provide only digital readout signal 3212.
In some implementations, the digital readout signal 3212 is
representative of an infrared signal 3220 of a surface temperature
that is detected by the digital infrared sensor 3208. In other
implementations, the digital readout signal 3212 is representative
of an infrared signal 3220 of a surface temperature of a human
other than the surface that is detected by the digital infrared
sensor 3208. A body core temperature estimator 3222 in the
microprocessor 3202 is configured to estimate the body core
temperature 3224 from the digital readout signal 3212 that is
representative of the infrared signal 3220 of the (or other
surface), a representation of an ambient air temperature reading
from an ambient air sensor 1710, a representation of a calibration
difference from a memory location that stores a calibration
difference 3226 and a memory location that stores a representation
of a bias 3228 in consideration of a temperature sensing mode. In
some implementations, the MVS device 3200 does not include an
analog-to-digital converter 3214 operably coupled between the
digital infrared sensor 3208 and the microprocessor 3202.
Furthermore, the digital infrared sensor 3208 also does not include
analog readout ports 3216. The dashed lines of the A/D converter
3214 and the analog readout ports 3216 indicates absence of the A/D
converter 3214 and the analog readout ports 3216 in the MVS device
3200.
[0207] A temperature estimation table 3230 is a lookup table that
correlates a sensed temperature to an estimated body core
temperature 3224. The sensed temperature is derived from the
digital readout signal 3212.
[0208] The temperature estimation table 3230 is stored in a memory.
In FIG. 34-FIG. 36, the temperature estimation table 3230 is shown
as a component of the microprocessor 3202. The memory that stores
the temperature estimation table 3230 can be separate from the
microprocessor 3202 or the memory can be a part of the
microprocessor 3202, such as cache on the microprocessor 3202.
Examples of the memory include Random Access Memory (RAM) 2608 and
flash memory 2610 in FIG. 26. In implementations of the MVS
smartphone systems in FIG. 29, FIG. 30 and FIG. 31, the apparatus
that estimates a body core temperature in FIG. 34-FIG. 36,
apparatus of the motion amplification in FIG. 40, the MVS
smartphone 2600 in which speed of the MVS smartphone systems in
FIG. 29, FIG. 30 and FIG. 31 and the apparatus that estimate a body
core temperature of an external source point in FIG. 34-FIG. 36 is
very important, storing the temperature estimation table 3230 in
memory that is a part of the microprocessor 3202, such as cache on
the microprocessor 3202, is very important.
[0209] The correlation between the sensed 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 4104 includes temperature estimation tables 3230
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 4104
include a temperature estimation table 3230 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 4104 include a
temperature estimation table 3230 for female humans of greater than
51 years of age, that are febrile and for temperature readings
taken between 2 am-8 am.
[0210] Some implementations of the MVS device 3200 include a
solid-state image transducer 2660 that is operably coupled to the
microprocessor 3202 and is configured to provide two or more images
2662 to a temporal-motion-amplifier 3232 and a biological vital
sign generator 3234 in the microprocessor 3202 to estimate one or
more biological vital signs 3236 that are displayed on the display
device 3218.
[0211] The MVS device 3200 includes any one of a pressure sensor
3238, a pressure cuff 3240, a micro dynamic light scattering (mDLS)
sensor 3242 and/or a physiological light monitoring (PLM) subsystem
3244 that provide signals to the biological vital sign generator
3234. 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 3238 is directly
linked to the pressure cuff 3240. In some implementations, the MVS
device 3200 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 3234 generates
blood pressure measurement (systolic and diastolic) from signals
from the pressure sensor 3238, the finger pressure cuff 3240 and
the mDLS sensor 3242. In some implementations, the biological vital
sign generator 3234 generates blood glucose levels from signals
from the PLM subsystem 3244. In some implementations, the
biological vital sign generator 3234 generates SpO2 measurement and
heart rate measurement from signals from the PLM subsystem 3244. In
some implementations, the biological vital sign generator 3234
generates respiration (breathing rate) measurement from signals
from the mDLS sensor 3242. In some implementations, the biological
vital sign generator 3234 generates blood flow measurement from
signals from the mDLS sensor 3242. In some implementations, the
biological vital sign generator 3234 generates heartrate
variability from signals from the PLM subsystem 3244. In some
implementations, the body core temperature estimator 3222 is
implemented in the biological vital sign generator 3234.
[0212] The MVS device 3200 also includes a wireless communication
subsystem 2604 or other external communication subsystem, such as
an Ethernet port, that provides communication to the EMR data
capture systems 4200 and 4200 or other devices. In some
implementations, the wireless communication subsystem 2604 is
communication subsystem 2604 in FIG. 38. The wireless communication
subsystem 2604 is operable to receive and transmit the estimated
body core temperature 3224 and/or the biological vital sign(s)
3236.
[0213] In some implementations, the digital infrared sensor 3208 is
a low noise amplifier, 17-bit ADC and powerful DSP unit through
which high accuracy and resolution of the estimated body core
temperature 3224 by the MVS smartphone systems in FIG. 29, FIG. 30
and FIG. 31, the apparatus that estimates a body core temperature
in FIG. 34-FIG. 36 and the MVS smartphone 2600.
[0214] In some implementations, the digital infrared sensor 3208,
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.
[0215] In some implementations, the digital infrared sensor 3208 is
packaged in an industry standard TO-39 package.
[0216] In some implementations, the generated object and ambient
air temperatures are available in RAM of the digital infrared
sensor 3208 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 3208.
[0217] In some implementations, the digital infrared sensor 3208 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.
[0218] In some implementations of the digital infrared sensor 3208,
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 3208 has a standard accuracy of
.+-.0.5.degree. C. around room temperatures, and in some
implementations, the digital infrared sensor 3208 has an accuracy
of .+-.0.2.degree. C. in a limited temperature range around the
human body core temperature.
[0219] 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 3208, 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.
[0220] In some implementations, the digital infrared sensor 3208 is
configured for an object emissivity of 1, but in some
implementations, the digital infrared sensor 3208 is configured for
any emissivity in the range 0.1 . . . 1.0 without the need of
recalibration with a black body.
[0221] In some implementations of the digital infrared sensor 3208,
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 3202 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.
[0222] In some implementations, the digital infrared sensor 3208
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.
[0223] In some implementations, the digital infrared sensor 3208 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.
[0224] 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.
[0225] In some implementations, the digital infrared sensor 3208
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.
[0226] In some implementations, the digital infrared sensor 3208
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 3208 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 3208 is in PWM mode, SMBus communication is
restored by a special command In some implementations, the digital
infrared sensor 3208 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.
[0227] The microprocessor 3202 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 3208 is a read operation, the digital
infrared sensor 3208 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 3202, the digital infrared sensor 3208 responds
and ignores the internal chip code information. In some
implementations, two digital infrared sensors 3208 are not
configured with the same slave address on the same bus.
[0228] In regards to bus protocol, after every received 8 bits, the
slave device should issue ACK or NACK. When a microprocessor 3202
initiates communication, the microprocessor 3202 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 3202 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
3202 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.
[0229] 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##
[0230] 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.
[0231] The different time intervals t1 . . . t4 have following
meaning:
[0232] t1: Start buffer. During t1 the signal is always high.
t1=0.125s.times.T (where T is the PWM period)
[0233] t2: Valid Data Output Band, 0 . . . 1/2T. PWM output data
resolution is 10 bit.
[0234] t3: Error band--information for fatal error in EEPROM
(double error detected, not correctable).
[0235] 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.
[0236] 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## [0237] For Data 2 field the equation is:
[0237] T OUT 2 = ( 4 t 5 T .times. ( T MAX 2 - T MIN 2 ) ) + T MIN
2 ##EQU00005##
[0238] In some implementations of FIG. 34-FIG. 36, the
microprocessor 3202, the image transducer 2660, the pressure sensor
3238, the pressure cuff 3240, the micro dynamic light scattering
(mDLS) sensor 3242 and/or the physiological light monitoring (PLM)
subsystem 3244 are located in the MVS finger cuff smartphone system
and the display devices 3218 and 3314 are located in the MVS
smartphone.
[0239] In some implementations of FIG. 34-FIG. 36, the image
transducer 2660, the pressure sensor 3238, the pressure cuff 3240,
the micro dynamic light scattering (mDLS) sensor 3242 and/or the
physiological light monitoring (PLM) subsystem 3244 are located in
the MVS finger cuff smartphone system and the microprocessor 3202
and the display devices 3218 and 3314 are located in the MVS
smartphone.
[0240] FIG. 33 is a block diagram of a MVS device 3300 that
includes a non-touch electromagnetic sensor with no temporal motion
amplifier, according to an implementation. The MVS device 3300 is
one example of the MVS apparatus 4104 and one example of the MVS
finger cuff accessory (MVSFCA) 3002. The MVS device 3300 includes a
battery 3204, in some implementations a single button 3206, in some
implementations a display device 3218, a non-touch electromagnetic
sensor 3302 and an ambient air sensor 1710 that are operably
coupled to the microprocessor 3202. The microprocessor 3202 is
configured to receive a representation of an infrared signal 3220
of the or other external source point from the non-touch
electromagnetic sensor 3302. The microprocessor 3202 includes a
body core temperature estimator 3222 that is configured to estimate
the body core temperature 3312 of the subject from the
representation of the electromagnetic energy of the external source
point.
[0241] The MVS device 3300 includes a pressure sensor 3238, a
pressure cuff 3240, a mDLS sensor 3242 and a PLM subsystem 3244
that provide signals to the biological vital sign generator 3234.
The pressure sensor 3238 is directly linked to the pressure cuff
3240. In some implementations, the MVS device 3300 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 3234 generates blood pressure
measurement (systolic and diastolic) from signals from the pressure
sensor 3238, the finger pressure cuff 3240 and the mDLS sensor
3242. In some implementations, the biological vital sign generator
3234 generates SpO2 measurement and heart rate measurement from
signals from the PLM subsystem 3244. In some implementations, the
biological vital sign generator 3234 generates respiration
(breathing rate) measurement from signals from the mDLS sensor
3242. In some implementations, the biological vital sign generator
3234 generates blood flow measurement from signals from the mDLS
sensor 3242. In some implementations, the biological vital sign
generator 3234 generates heartrate variability from signals from
the PLM subsystem 3244.
[0242] 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.
[0243] The non-touch electromagnetic sensor 3302 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 3302
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 3302 which constantly analyzes and registers
the ambient air temperature. When the operator of apparatus in FIG.
33 holds the non-touch electromagnetic sensor 3302 about 5-8 cm
(2-3 inches) from the and activates the radiation sensor, the
measurement is instantaneously measured. To measure a temperature
using the non-touch electromagnetic sensor 3302, pushing the button
3206 causes a reading of temperature measurement from the non-touch
electromagnetic sensor 3302 and in some implementations the
measured body core temperature is thereafter displayed on the
display device 3218. Various implementations of the non-touch
electromagnetic sensor 3302 can be a digital infrared sensor, such
as digital infrared sensor 3208 or an analog infrared sensor.
[0244] The body core temperature estimator 3222 correlates the
temperatures sensed by the non-touch electromagnetic sensor 3302 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 3222 can be
implemented as a component on a microprocessor, such as main
processor 2602 in FIG. 26 or on a memory such as flash memory 2610
in FIG. 26.
[0245] The MVS device 3300 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 3302
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.
[0246] The MVS device 3300 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.
[0247] The MVS device 3300 also includes a wireless communication
subsystem 2604 or other external communication subsystem, such as
an Ethernet port, that provides communication to the EMR data
capture systems 4200 and 4200. In some implementations, the
wireless communication subsystem 2604 is communication subsystem
2604 in FIG. 38.
8. Apparatus of Multi-Vital-Sign Components
[0248] FIG. 34 is a block diagram of an apparatus 3400 to estimate
a body core temperature from a temperature sensed by an infrared
sensor, according to an implementation. Apparatus 3400 includes a
power-initializer 3402 for the infrared sensor 3404 and a time
delay 3406 that delays subsequent processing for a period of time
specified by the time delay 3406 after power initialization of the
infrared sensor 3404 by the power-initializer 3402, such as a delay
of a minimum of 340 ms (+20 ms) to a maximum of 360 ms.
[0249] Apparatus 3400 includes a voltage level measurer 3408 of the
infrared sensor 3404 that outputs a representation of the sensor
voltage level 3410 of the infrared sensor 3404. When the sensor
voltage level 3410 is below 2.7V or is above 3.5V, a reading error
message 3412 is generated and displayed.
[0250] Apparatus 3400 also includes a sensor controller 3414 that
initiates four infrared measurements 3416 of the surface by the
infrared sensor 3404 and receives the four infrared measurements
3416. In some implementations, each of the four infrared
measurements 3416 of the surface are performed by the infrared
sensor 3404 with a period of at least 135 ms (+20 ms) to a maximum
of 155 ms between each of the infrared measurements 3416.
[0251] If one of the up to 15 infrared measurements 3416 of the
surface by the infrared sensor 3404 that is received is invalid, a
reading error message 3412 is displayed.
[0252] Apparatus 3400 also includes an ambient air temperature
controller 3418 that initiates an ambient air temperature (Ta)
measurement 3420 and receives the ambient air temperature (Ta)
measurement 3420. If the ambient air temperature (Ta) measurement
3420 of the ambient air temperature is invalid, a reading error
message 3412 is displayed. The ambient air temperature controller
3418 compares the ambient air temperature (Ta) measurement 3420 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 3420 is outside of this
range, a reading error message 3412 is displayed. The sensor
controller 3414 compares all four of the infrared measurements 3416
of the surface by the infrared sensor 3404 to determine whether or
not are all four are within 1 Kelvin degree of each other. If all
four infrared measurements of the surface by the infrared sensor
3404 are not within 1 Kelvin degree of each other, a reading error
message 3412 is displayed.
[0253] The sensor controller 3414 averages the four infrared
measurements of the surface to provide a received object
temperature (Tobj) 3422 when all four infrared measurements of the
surface by the infrared sensor 3404 are within 1 degree Kelvin of
each other. The sensor controller 3414 also generates a
voltage-corrected ambient air temperature (COvTa) 3424 and a
voltage-corrected object temperature (COvTobj) 3426 by applying a
sensor voltage correction 3428 to the ambient air temperature (Ta)
and the Tobj 3422, respectively. For example, the sensor voltage
correction 3428 in Kelvin=Tobj-(voltage at sensor-3.00)*0.65. In
some implementations, a sensor calibration offset is applied to the
COvTobj, resulting in a calibration-corrected voltage-corrected
object temperature (COcaCOvTobj) 3430. For example, a sensor
calibration offset of 0.60 Kelvin is added to each
voltage-corrected object temperature (COvTobj) from the infrared
sensor 3404 of a particular manufacturer.
[0254] An estimated body core temperature generator 3432 reads an
estimated body core temperature 3434 from one or more tables 3436
that are stored in a memory 3438 (such as memory 3438 in FIG. 34)
that correlates the COcaCOvTobj to the body core temperature in
reference to the COvTa 3424. One implementation of the estimated
body core temperature generator 3432 in FIG. 34 is apparatus 3500
in FIG. 35. The tables 3436 are also known as body core temperature
correlation tables.
[0255] A scale converter 3440 converts the estimated body core
temperature 3434 from Kelvin to .degree. C. or .degree. F.,
resulting in a converted body core temperature 3442. There is a
specific algorithm for pediatrics (<=8 years old) to account for
the different physiological response of children in the febrile
>101 deg F. range.
[0256] FIG. 35-FIG. 36 are block diagrams of an apparatus 3500 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 3500 is one implementation of the
estimated body core temperature generator 3432 in FIG. 34.
[0257] Apparatus 3500 includes an ambient air temperature
operating-range comparator 3502 that is configured to compare the
COvTa (3824 in FIG. 34) to an operational temperature range of the
apparatus to determine whether or not the COvTa 3424 is outside of
the operational temperature range of the apparatus. The operational
temperature range is from the lowest operational temperature of the
apparatus 3500 to the highest operational temperature of the MVS
system 2900. In one example, the operational temperature range is
10.0.degree. C. to 40.0.degree. C. In a further example, if the
C.OvTa is 282.15.degree. K (9.0.degree. C.), which is less than the
exemplary lowest operational temperature (10.0.degree. C.), then
the COvTa is outside of the operational temperature range.
[0258] Apparatus 3500 includes an ambient air temperature
table-range comparator 3504 that determines whether or not the
COvTa 3424 is outside of the range of the tables. For example, if
the C.OvTa is 287.15.degree. K (14.0.degree. C.), which is less
than the lowest ambient air temperature in the tables, then the
COvTa is outside of the range of the tables. In another example, if
the 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 COvTa is outside of the range of the
tables.
[0259] When the ambient air temperature table-range comparator 3504
determines that the COvTa 3424 is outside of the range of the
tables, then control passes to an ambient air temperature
range-bottom comparator 3506 that is configured to compare the
COvTa (3924 in FIG. 34) to the bottom of the range of the tables to
determine whether or not the COvTa 3424 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 C.OvTa 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 COvTa is less
than the bottom of the range of the tables.
[0260] When the ambient air temperature range-bottom comparator
3506 determines that the COvTa 3424 is less than the range of the
tables, control passes to an estimated body core temperature
calculator for hypo ambient air temperatures 3508 sets the
estimated body core temperature 3434 to the COcaC.OvTobj
3430+0.19.degree. K for each degree that the COvTa is below the
lowest ambient body core table.
[0261] For example, when the COvTa is 12.6.degree. C., which is
less than the range of the tables, 14.6.degree. C., and the
COcaCOvTobj 3430 is 29.degree. C. (302.15.degree. K) then the
estimated body core temperature calculator for hypo ambient air
temperatures 3508 sets the estimated body core temperature 3434 to
302.15.degree. K+(0.19.degree. K*(14.6.degree. C.-12.6.degree.
C.)), which is 302.53.degree. K.
[0262] When the ambient air temperature range-bottom comparator
3506 determines that the COvTa 3424 is not less than the range of
the tables, control passes to an estimated body core temperature
calculator 3510 for hyper ambient air temperatures that sets the
estimated body core temperature 3434 to the COcaC.OvTobj
3430-0.13.degree. K for each degree that the COvTa is above the
highest ambient body core table.
[0263] For example, when the COvTa is 45.9.degree. C., which is
above the range of all of the tables, (43.9.degree. C.), and the
COcaCOvTobj 3430 is 29.degree. C. (302.15.degree. K) then the
estimated body core temperature calculator 3510 for hyper ambient
air temperatures sets the estimated body core temperature 3434 to
302.15.degree. K-(0.13.degree. K*(45.9.degree. C.-43.9.degree.
C.)), which is 301.89.degree. K.
[0264] When the ambient air temperature table-range comparator 3504
determines that the COvTa 3424 is not outside of the range of the
tables, then control passes to an ambient air temperature table
comparator 3512 that determines whether or not the COvTa is exactly
equal to the ambient air temperature of one of the tables, when the
estimated body core temperature calculator 3510 for hyper ambient
air temperatures determines that the COvTa is within of the range
of the tables. When the ambient air temperature table comparator
3512 determines that the 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
3514 sets the estimated body core temperature 3434 to the body core
temperature of that one table, indexed by the COcaCOvTobj 3430.
[0265] For example, when the COvTa is 34.4.degree. C. (the ambient
air temperature of Table D) and the COcaCOvTobj 3430 is
29.1.degree. C., then the estimated body core temperature table
value selector for exact ambient air temperatures 3514 sets the
estimated body core temperature 3434 to 29.85 C, which is the body
core temperature of Table D indexed at the COcaCOvTobj 3430 of
29.1.degree. C.
[0266] Apparatus 3500 includes a table interpolation selector 3516.
When the ambient air temperature table comparator 3512 determines
that the COvTa is not exactly equal to the ambient air temperature
of one of the tables, then the table interpolation selector 3516
identifies the two tables which the COvTa falls between.
[0267] For example, if the C.OvTa 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.
[0268] Thereafter, apparatus 3500 includes a table interpolation
weight calculator 3520 that calculates a weighting between the
lower table and the higher table, the table interpolation weights
3522.
[0269] For example, when Tamb_bc_low (the COvTa for the Lower Body
Core Table)=19.6.degree. C. and T amb_bc_high (the 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%.
[0270] Apparatus 3500 includes a body core temperature reader 3524
that reads the core body core temperature that is associated with
the sensed temperature from each of the two tables, the Lower Body
Core Table and the Higher Body Core Table. The COcaCOvTobj 3430 is
used as the index into the two tables.
[0271] Apparatus 3500 also includes a correction value calculator
3526 that calculates a correction value 3528 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 COcaCOvTobj 3430 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 COcaCOvTobj 3430 falls between.
[0272] For example, when the COcaC.OvTobj 3430 is 309.03.degree. K,
then the COcaCOvTobj 3430 falls between 309.00 and 309.10. The
correction value 3528 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.
[0273] Thereafter, apparatus 3500 includes an estimated body core
temperature calculator for interpolated tables 3530 that determines
the body core temperature of the sensed 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).
[0274] For example, when the C.OvTa 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 3434.
[0275] The comparator 3502, comparator 3504 and comparator 3506 can
be arranged in any order relative to each other.
[0276] FIG. 37 is a block diagram of a digital infrared sensor
1312, according to an implementation. The digital infrared sensor
1312 contains a single thermopile sensor 3702 that senses only
infrared electromagnetic energy 3704. The digital infrared sensor
1312 contains a CPU control block 3706 and an ambient air
temperature sensor 3708, such as a thermocouple. The single
thermopile sensor 3702, the ambient air temperature sensor 3708 and
the CPU control block 3706 are on separate silicon substrates 3710,
3712 and 3714 respectively. The CPU control block 3706 digitizes
the output of the single thermopile sensor 3702 and the ambient air
temperature sensor 3708.
[0277] The digital infrared sensor 1312 has a Faraday cage 3716
surrounding the single thermopile sensor 3702, the CPU control
block 3706 and the ambient air temperature sensor 3708 to prevent
electromagnetic (EMF) interference in the single thermopile sensor
3702, the CPU control block 3706 and the ambient air temperature
sensor 3708 that shields the components in the Faraday cage 3716
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
3702, the CPU control block 3706 and the ambient air temperature
sensor 3708 are in close proximity to each other, which lowers
temperature differences between the single thermopile sensor 3702,
the CPU control block 3706 and the ambient air temperature sensor
3708, 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 3716 that surrounds the single thermopile sensor 3702, the CPU
control block 3706 and the ambient air temperature sensor 3708. The
Faraday cage 3716 can be a metal box or a metal mesh box. In the
implementation where the Faraday cage 3716 is a metal box, the
metal box has an aperture where the single thermopile sensor 3702
is located so that the field of view of the infrared
electromagnetic energy 3704 is not affected by the Faraday cage
3716 so that the infrared electromagnetic energy 3704 can pass
through the Faraday cage 3716 to the single thermopile sensor 3702.
In the implementation where the Faraday cage 3716 is a metal box,
the metal box has an aperture where the ambient air temperature
sensor 3708 is located so that the atmosphere can pass through the
Faraday cage 3716 to the ambient air temperature sensor 3708. In
other implementations the ambient air temperature sensor 3708 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
3708 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 3708 is to be in thermal
equilibrium with the target operating environment.
[0278] In some further implementations, the Faraday cage 3716 of
the digital infrared sensor 1312 also includes an multichannel
analogue-to-digital converter (ADC) 3718 that digitizes an analogue
signal from the single thermopile sensor 3702. The ADC 3718 also
digitizes an analogue signal from the ambient air temperature
sensor 3708. 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 3702 and the analogue
signal from the ambient air temperature sensor 3708. 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 3202 in FIG. 32.
[0279] The single thermopile sensor 3702 of the digital infrared
sensor 1312 is tuned to be most sensitive and accurate to the human
body core temperature range, such as 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 AT 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. 37, digital readout
signal 3212 in FIG. 32, digital signal that is representative of an
infrared signal of a 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 temperature in
FIG. 34 and the numerical representation of the electromagnetic
energy of the external source point in FIG. 63.
[0280] 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.
[0281] FIG. 38 is a block diagram of a wireless communication
system 3800, according to an implementation. The wireless
communication system 3800 includes a communication subsystem 2604
that includes a receiver 3802, a transmitter 3804, as well as
associated components such as one or more embedded or antennas 3806
and 3808, Local Oscillators (LOs) 3810, and a processing module
such as a digital signal processor (DSP) 3812. The particular
implementation of the wireless communication subsystem 2604 is
dependent upon communication protocols of a wireless network 2606
with which the mobile de MVS smartphone systems vice is intended to
operate. Thus, it should be understood that the implementation
illustrated in FIG. 38 serves only as one example. Examples of the
MVS smartphone system 2900 include MVS smartphone systems in FIG.
30 and FIG. 31, apparatus that estimates a body core temperature in
FIG. 34-FIG. 36 and MVS smartphone 2600. Examples of the wireless
network 3805 include network 2606 in FIG. 26.
[0282] Signals received by the antenna 3806 through the wireless
network 3805 are input to the receiver 3802, 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 3812. In a similar manner, signals to be
transmitted are processed, including modulation and encoding, by
the DSP 3812. These DSP-processed signals are input to the
transmitter 3804 for digital-to-analog (D/A) conversion, frequency
up conversion, filtering, amplification and transmission over the
wireless network 3805 via the antenna 3808. The DSP 3812 not only
processes communication signals, but also provides for receiver and
transmitter control. For example, the gains applied to
communication signals in the receiver 3802 and the transmitter 3804
may be adaptively controlled through automatic gain control
algorithms implemented in the DSP 3812.
[0283] The wireless link between the MVS apparatus 4104 and the
wireless network 3805 can contain one or more different channels,
typically different RF channels, and associated protocols used
between the MVS apparatus 4104 and the wireless network 3805. 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 4104.
[0284] When the MVS apparatus 4104 are fully operational, the
transmitter 3804 is typically keyed or turned on only when it is
transmitting to the wireless network 3805 and is otherwise turned
off to conserve resources. Similarly, the receiver 3802 is
periodically turned off to conserve power until the receiver 3802
is needed to receive signals or information (if at all) during
designated time periods.
[0285] Each patient record 3814 is received by the wireless
communication subsystem 2604 from the main processor 2602 at the
DSP 3812 and then transmitted to the wireless network 3805 through
the antenna 3806 of the receiver 3802. In some implementations,
each patient record 3814 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.
[0286] FIG. 39 is a block diagram of an apparatus 3900 to generate
a predictive analysis of vital signs, according to an
implementation. The apparatus 3900 can be implemented on the MVS
finger cuff accessory (MVSFCA) 2902 in FIG. 29, the MVS smartphone
(MVS Smartphone) 2904 in FIG. 29, the MVS finger cuff accessory
(MVSFCA) 3002 in FIG. 30 or the MVS smartphone 3003 in FIG. 30, the
sensor management component 3302 in FIG. 33, the microprocessor
3320 in FIG. 33, the MVS finger cuff 1704 in FIG. 17 and FIG. 7,
the microprocessor 1702 in FIG. 17, controller 1826 in FIG. 18, the
microprocessor 3320 in FIG. 31 and/or main processor 2602 in FIG.
26. In apparatus 3900, blood glucose levels 3902, heartrate data
3904, respiratory rate data 3906, estimated body core temperature
data 3908 (such as estimated body core temperature 3224 in FIG. 32
or estimated body core temperature 3434 in FIG. 34-FIG. 36), blood
pressure data 3910, EKG data 3912 and/or SpO2 data 3914 is received
by a predictive analysis component 3916 that evaluates the data
3902, 3904, 3906, 3908, 3910, 3912 and/or 3914 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 3918 is set to indicate an anomaly. The flag 3918 can be
transmitted to the EMR/clinical data repository 4244, as shown in
FIG. 42.
[0287] FIG. 40 is a flowchart of a method 4000 of motion
amplification from which to generate and communicate biological
vital signs, according to an implementation. FIG. 40 uses spatial
and temporal signal processing to generate biological vital signs
from a series of digital images.
[0288] Method 4000 analyzes the temporal and spatial motion in
digital images of an animal subject in order to generate and
communicate the biological vital signs.
[0289] In some implementations, method 4000 includes cropping
plurality of images to exclude areas that do not include a skin
region, at block 4002. 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 4002 in method 4000 can reduce the processing time
of the plurality of images 2662 by 86%, which is of significant
difference to the health workers who used devices that implement
method 4000. 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
a cropper module that performs block 4002 is placed at the
beginning of the modules to greatly decrease processing time of the
apparatus.
[0290] In some implementations, method 4000 includes identifying
pixel-values of the plurality of or more cropped images that are
representative of the skin, at block 4004. 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.
[0291] In some implementations, method 4000 includes applying a
spatial bandpass filter to the identified pixel-values, at block
4006. In some implementations, the spatial filter in block 4002 is
a two-dimensional spatial Fourier Transform, a high pass filter, a
low pass filter, a bandpass filter or a weighted bandpass
filter.
[0292] In some implementations, method 4000 includes applying
spatial clustering to the spatial bandpass filtered identified
pixel-values of skin, at block 4008. In some implementations the
spatial clustering includes fuzzy clustering, k-means clustering,
expectation-maximization process, Ward's method or seed point based
clustering.
[0293] In some implementations, method 4000 includes applying a
temporal bandpass filter to the spatial clustered spatial bandpass
filtered identified pixel-values of skin, at block 4010. 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.
[0294] In some implementations, method 4000 includes determining
temporal motion of the temporal bandpass filtered spatial clustered
spatial bandpass filtered identified pixel-values of skin, at block
4012.
[0295] In some implementations, method 4000 includes analyzing the
temporal motion to generate and visually display a pattern of flow
of blood, at block 4014. 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 4000 includes displaying the pattern of
flow of blood for review by a healthcare worker, at block 4016.
[0296] In some implementations, method 4000 includes analyzing the
temporal motion to generate heartrate, at block 4018. 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 4000
includes displaying the heartrate for review by a healthcare
worker, at block 4020.
[0297] In some implementations, method 4000 includes analyzing the
temporal motion to determine respiratory rate, at block 4022. 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 4000 includes displaying
the respiratory rate for review by a healthcare worker, at block
4024.
[0298] In some implementations, method 4000 includes analyzing the
temporal motion to generate blood pressure, at block 4026. 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 4000 includes displaying the blood
pressure for review by a healthcare worker, at block 4028.
[0299] In some implementations, method 4000 includes analyzing the
temporal motion to generate EKG, at block 4030. In some
implementations, method 4000 includes displaying the EKG for review
by a healthcare worker, at block 4032.
[0300] In some implementations, method 4000 includes analyzing the
temporal motion to generate pulse oximetry, at block 4034. 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 4000 includes displaying
the pulse oximetry for review by a healthcare worker, at block
4034.
9. Apparatus of Interoperability Device Manager Components of an
EMR System
[0301] FIG. 41 is a block diagram of a system of interoperability
device manager component 4100, according to an implementation. The
interoperability device manager component 4100 includes a device
manager 4102 that connects one or more MVS apparatus 4104 and
middleware 4106. The MVS apparatus 4104 are connected to the device
manager 4102 through via a plurality of services, such as a chart
service 4108, an observation service 4110, a patient service 4112,
a user service and/or an authentication service 4116 to a bridge
4118 in the interoperability device manager 4102. The MVS apparatus
4104 are connected to the device manager 4102 to a plurality of
maintenance function components 4120, such as push firmware 4122, a
push configuration component 4124 and/or a keepalive signal
component 4126. The keepalive signal component 4126 is coupled to
the middleware 4106. In some implementations, the APIs 4130, 4132,
4134 and 4136 are health date APIs, observation APIs, electronic
health record (EHR) or electronic medical record (EMR) APIs.
[0302] The bridge 4118 is operably coupled to a greeter component
4128. The greeter component 4128 synchronizes date/time of the
interoperability device manager 4102, checks device log, checks
device firmware, checks device configuration and performs
additional security. The greeter component 4128 is coupled to the
keepalive signal component 4126 through a chart application program
interface component 4130, a patient application program interface
component 4132, a personnel application program interface component
4134 and/or and authentication application program interface
component 4136. All charted observations from the chart application
program interface component 4130 are stored in a diagnostics log
4138 of a datastore 4140. The datastore 4140 also includes
interoperability device manager settings 4142 for the application
program interface components 4130, 4132, 4134 and/or 4136, current
device configuration settings 4144, current device firmware 4146
and a device log 4148.
[0303] The interoperability device manager 4102 also includes a
provision device component 4150 that provides network/Wi-Fi.RTM.
Access, date/time stamps, encryption keys--once for each of the MVS
apparatus 4104 for which each MVS apparatus 4104 is registered and
marked as `active` in the device log 4148. The provision device
component 4150 activates each new MVS apparatus 4104 on the
interoperability device manager component 4100 through a device
activator 4152. Examples of the MVS apparatus 4104 include the MVS
finger cuff accessories in FIG. 12-FIG. 18, apparatus of the MVS
finger clips in FIG. 19-FIG. 25, the MVS smartphones in FIG.
26-FIG. 28, the MVS smartphone systems in FIG. 29-FIG. 31 and the
MVS devices in FIG. 32-FIG. 33.
[0304] FIG. 42 is a block diagram of apparatus of an EMR capture
system 4200, according to an implementation in which an
interoperability manager component manages all communications in
the middle layer. In EMR capture system 4200, an interoperability
device manager component 4100 manages all communications in the
middle layer 4206 between the device/user layer 4202 and the first
set of application program interfaces 4214, the optional second set
of application program interfaces 4216, one or more hubs 4218,
bridges 4220, interface engines 4222 and gateways 4224 in the
middle layer 4206. The EMR/clinical data repository 4244 includes
an EMR system 4246, a clinical monitoring system 4252 and/or a
clinical data repository 4254. The EMR system 4246 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..
[0305] Some other implementations of an electronic medical records
capture system include a bridge that transfers patient record 3814
from MVS apparatus 4104 to EMR systems in hospital and clinical
environments. Each patient record 3814 includes patient measurement
data, such as biological vital sign 3236 in FIG. 32-FIG. 33, blood
glucose level 4502 in FIG. 45, biological vital sign 3236 in FIG.
32-FIG. 33 and vital sign in FIG. 42. The EMR data capture system
includes two important aspects: 1.A server bridge to control the
flow of patient measurement data from MVS apparatus 4104 to one or
more and to manage local MVS apparatus 4104. 2. The transfer of
patient measurement data in a patient record 3814, anonymous, and
other patient status information to a cloud based EMR/clinical data
repository 4244. The bridge controls and manages the flow of
patient measurement data to an EMR/clinical data repository 4244
and another EMR/clinical data repository 4244 and provides
management services to MVS apparatus 4104. The bridge provides an
interface to: a wide range of proprietary EMR/clinical data
repository 4244, location specific services, per hospital, for
verification of active operator, and if necessary, patient
identifications, and a cloud based EMR/clinical data repository
4244) of one or more MVS apparatus 4104, 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 4104 to: Data format
conversion and transferring patient measurement records to
EMR/clinical data repository 4244, manage the firmware and
configuration settings of the MVS apparatus 4104, determine current
health and status of the MVS apparatus 4104, 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 4104,
support for firmware update mechanism of firmware MVS apparatus
4104. 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 4104. 2) Remote or cloud based EMR/clinical data
repository 4244 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 4104. The bridge
provides a central management system for the MVS apparatus 4104
that provides at least the following functions: 1) configuration
management and update of the MVS apparatus 4104 2) device level
firmware for all of the MVS apparatus 4104 and 3) management and
reporting methods for the MVS apparatus 4104. The management and
reporting methods for the MVS apparatus 4104 provides (but not
limited to) health and status of the MVS apparatus 4104, battery
level, replacement warning of the MVS apparatus 4104,
check/calibration nearing warning of the MVS apparatus 4104,
rechecking due to rough handling or out of calibration period of
the MVS apparatus 4104, history of use, number of measurements,
frequency of use etc. of the MVS apparatus 4104, display of current
device configuration of the MVS apparatus 4104, Date/time of last
device communications with each of the MVS apparatus 4104. 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 4104 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
4104 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
4244 are operably coupled to the network via the Internet.
[0306] In some implementations, a push data model is supported by
the EMR data capture system between the MVS apparatus 4104 and the
bridge in which connection and data are initially pushed from the
MVS apparatus 4104 to the bridge. Once a connection has been
established and the MVS apparatus 4104 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 4104 and the EMR/clinical data repository 4244. In some
implementations, the MVS apparatus 4104 are connected via a
wireless communication path, such as a Wi-Fi.RTM. connection to
Wi-Fi.RTM. access point(s). In other implementations, the MVS
apparatus 4104 are connected to a docking station via a wireless or
physical wired connection, such as local Wi-Fi.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-Fi.RTM. link from the docking station to the bridge.
In some implementations, the MVS apparatus 4104 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 4104 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-Fi.RTM. communication path, or
a Wi-Fi.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 4104 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 4104 additional
control over their own power management usage and lifetime. In some
implementations in which the MVS apparatus 4104 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
4104 and thus connect the MVS smartphone system to the bridge more
quickly. More specifically, the MVS apparatus 4104 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 4104 have a HTTP address of a
remote sever that acts as a discovery node for the MVS apparatus
4104 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 4104 on the network requires
configuration of the MVS apparatus 4104 for the bridge of IP
address and other essential network configuration and security
information. Commissioning of a MVS apparatus 4104 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 4104 on the network,
such as deployment, operational and decommissioning. In some
implementations the initial network configuration of the MVS
apparatus 4104 does not require the MVS apparatus 4104 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 4104 and for diagnostic test of the MVS apparatus 4104.
MVS apparatus 4104 can be factory configured for known network
settings and contain a default server IP address on the
commissioning network. In addition the MVS apparatus 4104 are
required in some implementations to support a protocol based
command to reset the MVS apparatus 4104 to network factory defaults
for test purposes. In some situations, the firmware revision(s) of
the MVS apparatus 4104 are not consistent between all of the MVS
apparatus 4104 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 4104. As a result, different
revision levels of the MVS apparatus 4104 can be supported at the
same time on the network by the bridge for all operations.
Implementation Alternatives
Operational Features and Implementation Capability
[0307] Some implementations of the EMR data capture systems 4200
have limited operational features and implementation capability. A
significant function of the EMR data capture systems 4200 with the
limited operational features and implementation capability in the
bridge 4220 is to accept data from a MVS apparatus 4104 and update
the EMR/Clinical Data Repository 4244. The EMR/Clinical Data
Repository 4244 can be one or more of the following: Electronic
Medical Records System(EMR) 4246, Clinical Monitoring System 4252
and/or Clinical Data Repository 4254.
[0308] The following limited feature set in some implementations is
supported by the EMR data capture systems 4200 and 4200 for the
demonstrations:
[0309] 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.
[0310] Acceptance of patient medical records from a MVS apparatus
4104:
[0311] a. Date and Time
[0312] b. Operator identification
[0313] c. Patient identification
[0314] d. Vital Sign measurement(s)
[0315] e. Device manufacturer, model number and firmware
revision
[0316] Acceptance of limited status information from a MVS
apparatus 4104:
[0317] a. Battery Level
[0318] b. Hospital reference
[0319] c. location reference
[0320] d. Manufacturer identification, serial number and firmware
revision
[0321] e. Unique identification number
[0322] Transfer of patient records from a MVS apparatus 4104 to a
third party EMR capture system and to the EMR data capture systems
4200, respectively in that order.
[0323] User interface for status review of known MVS apparatus
4104.
[0324] Configuration update control for active devices providing
configuration of:
[0325] a. Hospital reference b. Unit location reference
Limited Operational Features and Implementation Capability
[0326] The following features are supported limited operational
capability:
[0327] A Patient Record Information and measurement display
interface for use without submission of that data to an
EMR/Clinical Data Repository 4244.
[0328] 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
[0329] In some implementations, the MVS apparatus 4104 are deployed
to a local hospital, or other location, wireless IT network that
supports Wi-Fi.RTM. enabled devices. The MVS apparatus 4104
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 4104 operates on both physical
and virtual wireless LAN's, WAN's, and the MVS apparatus 4104 are
configured for operation on a specific segment of the network.
Depending on the IT network structure, when the MVS apparatus 4104
is configured for operation on a specific segment of the network,
the MVS apparatus 4104 network connection ability is limited to the
areas of the operational environment for which it as be configured.
Therefore, the MVS apparatus 4104 in network environments that have
different network configurations are configured to ensure that when
the MVS apparatus 4104 are used in various locations throughout the
environment that the MVS apparatus 4104 has access in all required
areas.
[0330] In some implementations the bridge 4220 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 4104 on this
network are able to determine a routable path to the bridge 4220.
The MVS apparatus 4104 and the server are not required to implement
any network name discovery protocols and therefore the bridge 4220
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 4220 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 4220 is configured to meet the security and
access requirements of a single organization.
[0331] An implementation of a remote cloud-based bridge 4220 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 4220 may not be physically located at the physical site of
the MVS apparatus 4104.
[0332] The MVS apparatus 4104 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.
[0333] The physical locale of the bridge 4220 is transparent to the
MVS apparatus 4104.
Remote Based--Multiple Client Support
[0334] In some implementations for smaller organizations or for
organizations that do not have a supporting IT infrastructure or
capability that a remote bridge 4220 system is deployed to support
more than one organization. Where the bridge 4220 is deployed to
support more than one organization, the bridge 4220 can be hosted
as a cloud based system. In this case the MVS apparatus 4104 are
located at the operational site for the supported different
geographical location organizations and tied to the bridge 4220 via
standard networking methods via either private or public
infrastructure, or a combination thereof.
[0335] 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 4200 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 4200 be used and their EMR data
capture systems 4200 are concurrently operational with many diverse
EMR/Clinical Repository systems such as Electronic Medical Record
System EMR 4246, Clinical Monitoring System 4252 and/or Clinical
Data Repository 4254.
Single Measurement Update
[0336] The primary function of the MVS apparatus 4104 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 4244.
Normally the MVS apparatus 4104 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 system 4200 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 4220 for saving
using the EMR data capture system 4200.
[0337] 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 4220.
[0338] In some implementations, the confirmation at each stage in
some implementations is provided by the operator through either the
bridge 4220, MVS apparatus 4104, or the EMR/Clinical Data
Repository 4244.
[0339] When confirmation is provided by the bridge 4220 it is an
acknowledgment to the MVS apparatus 4104 that the bridge 4220 has
accepted the information for transfer to the EMR/Clinical Data
Repository 4244 in a timely manner and is now responsible for the
correct management and transfer of that data.
[0340] When confirmation is provided by the EMR, the bridge 4220 is
one of the mechanisms via which the confirmation is returned to the
MVS apparatus 4104. That is the MVS apparatus 4104 sends the data
to the bridge 4220 and then waits for the bridge 4220 to send the
data to the EMR and for the EMR to respond to the bridge 4220 and
then the bridge 4220 to the MVS apparatus 4104,
[0341] In some implementations depending on the operational network
and where the bridge 4220 is physically located, i.e. local or
remote, that the type of confirmation is configurable.
[0342] In some implementations, the MVS apparatus 4104 maintains an
internal non-volatile storage mechanism for unsaved patient records
if any or all of these conditions occur: The MVS apparatus 4104
cannot join the network. The MVS apparatus 4104 cannot communicate
with the bridge 4220. The MVS apparatus 4104 does not receive level
confirmation from either the bridge 4220 or the EMR/Clinical Data
Repository 4244. The MVS apparatus 4104 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 4104 has saved records present in internal memory of
the MVS apparatus 4104, then the MVS apparatus 4104 attempts to
transfer the saved records to the bridge 4220 for processing in a
timely automatic manner
Periodic Connectivity
[0343] The MVS apparatus 4104 in order to obtain date/time,
configuration setting, provides status information to the bridge
4220, 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 4220 without operator intervention.
[0344] Accordingly, outside of the normal clinical use activation
for the MVS apparatus 4104, the MVS apparatus 4104 can both update
its internal settings, and provide status information to the bridge
4220 system.
Automatic Transfer of Saved Patient Measurement Records (PMRs)
[0345] If the MVS apparatus 4104 for an unknown reason has been
unable to either join the network or connect to the bridge 4220 or
receive a bridge 4220 or EMR data level acknowledge that data has
been saved the MVS apparatus 4104 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 4104.
[0346] When the MVS apparatus 4104 are started for a measurement
action the MVS apparatus 4104 determines if the MVS apparatus 4104
contains any saved patient records in its internal memory. If one
or more saved patient records are detected then the MVS apparatus
4104 attempts to join the network immediately, connect to the
bridge 4220 and send the patient records one at a time to the
bridge 4220 device while waiting for the required confirmation that
the bridge 4220 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 4104 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 4104 internal
memory for a transfer attempt on the next power up of the MVS
apparatus 4104.
[0347] The MVS apparatus 4104 on a configured interval will also
carry out this function. In some implementations the MVS apparatus
4104 reduces the interval when saved patient records are present on
the MVS apparatus 4104 in order to ensure that the records are
transferred to the bridge 4220, and subsequently the EMR/Clinical
Data Repository 4244, 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 4104 screen.
[0348] Under this operation it is possible for the bridge 4220
device to receive from a single MVS apparatus 4104 multiple patient
record transfer requests in rapid sequence.
Device Configuration
[0349] The MVS apparatus 4104 upon 1) connection to the bridge
4220, 2) configured interval or 3) operator initiation, transmits
to the bridge 4220 with the model number and all appropriate
revisions numbers and unique identification of the MVS apparatus
4104 to allow the bridge 4220 to determine the MVS apparatus 4104
capabilities and specific configurations for that MVS apparatus
4104.
[0350] The bridge 4220 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 4104
queries the bridge 4220 for the device vital-signs of the MVS
apparatus 4104 and if the queried device vital-signs are different
from the MVS apparatus 4104, the MVS apparatus 4104 updates the
current setting to the new setting values as provided by the bridge
4220.
Device Status Management
[0351] In some implementations the bridge 4220 provides a level of
device management for the MVS apparatus 4104 being used with EMR
data capture system 4200. In some implementations, the bridge 4220
is able to report and determine at least the following:
[0352] 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 4104, e.g. ward location reference or Hospital
reference.
[0353] The last time a specific unit connected to EMR data capture
system 4200.
[0354] 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 4104.
[0355] Report devices out of their calibration period, or
approaching their calibration check.
[0356] Report devices that require their internal battery
replaced.
[0357] 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.
Firmware Update
[0358] 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 4104 is activated for a patient measurement
firmware, updates are blocked because the update process delays the
patient biological vital sign measurement. Instead the bridge 4220
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.
[0359] In some implementations, when a MVS apparatus 4104 connects
to the bridge 4220 due to a heartbeat event that the MVS apparatus
4104 queries the bridge 4220 to determine if a firmware update for
that model of device is available and verify if the firmware MVS
apparatus 4104 (via revision number), is required to be updated.
The bridge 4220 responds to the query by the MVS apparatus 4104
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 4220 but the current time and date is not valid for
the schedule then the bridge 4220 transmits a message to the MVS
apparatus 4104 that there is an update but that the update process
is delayed and update the MVS apparatus 4104 firmware check
interval configuration. The firmware check interval setting will
then be used by the MVS apparatus 4104 to reconnect to the bridge
4220 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 4220 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.
[0360] In some implementations the bridge 4220 manages the firmware
update process for many different MVS apparatus 4104 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
4220 will provide a mechanism to manage and validate the firmware
update files maintained on the bridge 4220 for use with the MVS
apparatus 4104.
[0361] This section concludes with short notes below on a number of
different aspects of the EMR data capture system 4200 follow on
numerous topics:
[0362] Remote--single client operation: The bridge 4220
architecture provide remote operation on a hospital network system.
Remote operation is seen as external to the network infrastructure
that the MVS apparatus 4104 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 system 4200 but one bridge 4220 device
services all hospital locations and the bridge 4220 is located at
one of the hospital sites or their IT center.
[0363] Remote--multiple client operation: The bridge 4220
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.
[0364] Multiple concurrent EMR support: For a single remote bridge
4220 servicing multiple clients EMR data capture system 4200
supports connectivity to an independent EMR, and a different EMR
vendor, concurrently for each supported client. With one bridge
4220 servicing multiple clients in some implementations, each
client requires the configuration to send data securely to
different EMR/Clinical Data Repositories.
[0365] Support Different EMR for same client: The bridge 4220
architecture for operation in a single client organization supports
the user by the organization of different EMR/Clinical Data
Repository 4244 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 4244 for different operational environments, for
example, Cardiology and ER. EMR data capture system 4200 in some
implementations takes this into account and routes the patient data
to the correct EMR/Clinical Data Repository 4244. Therefore the
bridge 4220 is informed for a given MVS apparatus 4104 which
indicates to the EMR the medical data has to be routed to.
[0366] Segregation of operations for multiple client operations on
a single bridge 4220: EMR data capture system 4200 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 4220
in some implementations maintain all functionality, and performance
per client separately and ensure that separate user accounts,
bridge 4220 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.
[0367] Multiple organization device support: The bridge 4220
supports at least 1 million+ MVS apparatus 4104 for a remote
implementations that services multiple separate hospital systems.
The supported MVS apparatus 4104 can be MVS apparatus 4104 from
different manufacturers.
[0368] EMR capture system support: The MVS apparatus 4104 supports
a wide range implementations of the EMR data capture system 4200
and is capable of interfacing to any commercially deployed
EMR/Clinical Data Repository 4244.
[0369] EMR capture system interface and approvals: The bridge 4220
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 4244 supported
by the EMR data capture system 4200.
[0370] Remote EMR capture system(s): The bridge 4220 supports
interfacing to the required EMR/Clinical Data Repository 4244
independent of the EMR data capture system 4200 location, either
locally on the same network infrastructure or external to the
network that the bridge 4220 is resided on or a combination of
both. The EMR data capture system 4200, or systems, that the bridge
4220 is required to interact with and save the patient to can not
be located on the same network or bridge 4220 implementation
location, therefore the bridge 4220 implementation in some
implementations ensure that the route to the EMR exists, and is
reliable.
[0371] Bridge buffering of device patient records: The bridge 4220
device provides a mechanism to buffer received PMRs from connected
MVS apparatus 4104 in the event of a communications failure to the
EMR/Clinical Data Repository 4244, 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 4220 is lost. If communications
has been lost to the configured EMR data capture system 4200 then
the bridge 4220 in some implementations accepts measurement records
from the MVS apparatus 4104 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 4220 for secure
subsequent processing. In this event the bridge 4220 will respond
to the MVS apparatus 4104 that either 1. Dynamic validation of EMR
acceptance is not possible, or 2. The bridge 4220 has accepted the
data correctly.
[0372] Bridge 4220 real time acknowledge of EMR save to device: The
bridge 4220 provides a mechanism to pass to the MVS apparatus 4104
confirmation that the EMR has accepted and saved the PMR. The
bridge 4220 when configured to provide the MVS apparatus 4104 with
real time confirmation that the EMR/Clinical Data Repository 4244
(s) have accepted and validated the PMR. This is a configuration
option supported by the bridge 4220.
[0373] Bridge 4220 real time acknowledgement of acceptance of
device PMR: The bridge 4220 provides a mechanism to pass to the MVS
apparatus 4104 confirmation that the bridge 4220 has accepted the
PMR for subsequent processing to the EMR. The MVS apparatus 4104 in
some implementations verifies that the bridge 4220 has accepted the
PMR and informs the operator of the MVS apparatus 4104 that the
data is secure. This level of confirmation to the MVS apparatus
4104 is considered the minimum level acceptable for use by the EMR
data capture system 4200. Real time acknowledgement by the bridge
4220 of acceptance of the PMR from the device is a configuration
option supported by the bridge 4220.
[0374] Bridge Date and Time: The bridge 4220 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 4220. The MVS apparatus 4104 will query the bridge
4220 for the current date and time to update its internal RTC. The
internal time MVS apparatus 4104 can be maintained to a+/-1 second
accuracy level, although there is no requirement to maintain time
on the MVS apparatus 4104 to sub one-second intervals.
[0375] Graphical User Interface: The bridge 4220 device provides a
graphical user interface to present system information to the
operator, or operators of EMR data capture system 4200. The user
interface presented to the user for interaction with EMR data
capture system 4200 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.
[0376] Logging and log management: The bridge 4220 is required to
provide a logging capability that logs all actions carried out on
the bridge 4220 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/disabled per MVS smartphone
system or for product range of MVS smartphone system.
[0377] User Accounts: The bridge 4220 device provides a mechanism
to support user accounts on the MVS apparatus 4104 for access
control purposes. Standard methods for user access control are
acceptable that complies with the operational requirements for the
install/implementation site.
[0378] User Access Control: The bridge 4220 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 system 4200 in some implementations be controlled at a
functional level, In some implementations, the following levels of
access is provided:
[0379] System Admin: provides access to all features and functions
of EMR data capture system 4200, server and device based.
[0380] Device Admin: provides access only to all device related
features and functions supported by the EMR data capture system
4200.
[0381] Device Operator: provides access only to device usage.
[0382] Device Installer: provides access only to device
commissioning and test capabilities.
[0383] A user account can be configured for permissions for one or
more account types.
[0384] Multi-User Support: The bridge 4220 device is required to
provide concurrent multi-user support for access and management of
the bridge 4220 system across all functions. Providing multiple
user access is deemed a necessary operational feature to
support.
[0385] Modify User Accounts: The bridge 4220 provides a method to
create, delete, and edit the supported user accounts and supported
access privileges per account.
[0386] Bridge Data Corruption/Recovery: The bridge 4220
architecture and implementation in some implementations ensure that
under an catastrophic failure of EMR data capture system 4200 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 system 4200. The bridge 4220 supports a method
to ensure zero data lost under critical and catastrophic system
failure of the bridge 4220 or any of the bridge 4220 components,
network interfaces, storage systems, memory contents, etc. for any
data handled by the EMR data capture system 4200. In the event of a
recovery action where a catastrophic failure has occurred EMR data
capture system 4200 supports both the recovery action and its
normal operational activities to ensure that EMR data capture
system 4200 is active for clinical use.
[0387] Bridge availability: The bridge 4220 device is a high
availably system for fail safe operation 24/7/365, with 99.99%
availability, i.e. "four nines" system. The bridge 4220
implementation meets an availability metric of 99.99%, i.e. a "four
nines" system because the bridge 4220 hardware in some
implementations is implemented with a redundant dual server
configuration to handle single fault conditions. The bridge 4220
has an independent power source or when the installation site has a
policy for power loss operation the bridge 4220 installation in
some implementations complies with the policy requirements.
[0388] Bridge Static IP address and port Number: The bridge 4220
provides a mechanism to configure the bridge 4220 for a primary use
static IP address and port number. For MVS apparatus 4104
connection to the bridge 4220, the bridge 4220 in some
implementations has a static IP address and that IP address in some
implementations is known by the MVS apparatus 4104.
[0389] Bridge Dual network capability: The bridge 4220 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 4220
implementation for EMR data capture system 4200 employs two
separate bridges 4220 or other redundant mechanism to provide a
backup system then this requirement can be relaxed from an
operational view point, however EMR data capture system 4200 in
some implementations support this mechanism.
[0390] Local Wi-Fi.RTM. commissioning network: The bridge 4220
provides a mechanism on the local operational network to commission
new MVS apparatus 4104 for operational use. EMR data capture system
4200 supplies a localized isolated network for the use of
commissioning new devices onto the operational network. The bridge
4220 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 system 4200. The commissioning of new devices is to be
considered a core aspect of the bridge 4220 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 4104 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 4104 for clinical/system function operation.
[0391] Remote commissioning of devices: EMR data capture system
4200 provides a mechanism where the bridge 4220 device is not
present on the local network for a new device is to be commissioned
on the operational network. Even when the bridge 4220 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 4220 was a local server. This does not
preclude the installation of a commission relay server on to the
operational network that supports this mechanism.
[0392] Device setup: The bridge 4220 supports the configuration of
a device level network operation and security settings for an
existing or new MVS apparatus 4104 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 4104 are
currently connected to the bridge 4220 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 4104 have been configured
correctly but be presented to the operator to prove that the MVS
apparatus 4104 are operational. Devices support a network command
to reboot and rejoin the network for this verification purpose.
[0393] Bridge Configuration: The bridge provides a mechanism to
support configuration of all required specific control options of
the bridge 4220. A method to configure the bridge 4220 functions in
some implementations is provided for all features where a
configuration option enable, disable or a range of vital-signs are
required.
[0394] Bridge MVS smartphone system acknowledgement method: The
bridge 4220 provides a configuration method to control the type of
acknowledgement required by the EMR data capture system 4200, one
of: device configuration dependent, EMR level acknowledgment,
bridge 4220 level acknowledgement. In some implementations, a MVS
apparatus 4104 requires from the bridge an acknowledgement that the
PMR has been saved by the EMR data capture system 4200 or accepted
for processing by the bridge 4220.
[0395] EMR Level: Bridge 4220 confirms save by EMR data capture
system 4200.
[0396] Bridge Level: bridge 4220 controlled, accepted for
processing by the bridge 4220.
[0397] Enabled/Disable of firmware updated mechanism: The bridge
4220 provides a method to globally enable or disable the supported
MVS apparatus 4104 firmware updated feature. A global
enable/disable allows the control of the firmware update
process.
[0398] Server Management: The bridge 4220 is required to provide a
user interface that provides configuration and performance
monitoring of the bridge 4220 and platform functions.
[0399] System Reporting: The bridge 4220 is required to provide a
mechanism to provide standard reports to the operator on all
capabilities of the bridge 4220 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 system 4200, with location
reference and date and time of last connection Report on the
battery status for all known MVS apparatus 4104. 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.
[0400] Demo Patient Interface: The bridge 4220 provides a mechanism
for demo only purposes where an EMR data capture system 4200 is not
available for interfacing to EMR data capture system 4200 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 system 4200 where there is no EMR data capture system
4200 to connect the bridge 4220 the system provides a user
interface method to present the data sent to the bridge 4220 by the
connected MVS apparatus 4104. 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
[0401] Interface to EMR/clinical data repository 4244: The bridge
4220 device provides an interface to the EMR/clinical data
repository 4244 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 4104.
[0402] Device PMRs: The bridge 4220 in some implementations accepts
propriety formatted measurement records from MVS apparatus 4104
connected and configured to communicate with the bridge 4220 and
translate the received measurement record into a suitable format
for transfer to a EMR data capture system 4200. The bridge 4220 is
the MVS apparatus 4104 that will take the MVS apparatus 4104 based
data and translate that data into a format suitable to pass along
to a local or remote EMR/Clinical Data Repository 4244 system using
the required protocols of that EMR/Clinical Data Repository
4244.
[0403] Device non patient measurement data: The bridge 4220 in some
implementations accepts data from connected MVS apparatus 4104 and
provides data to a connected device. This is data or setting
vital-signs associated with the MVS apparatus 4104 that in some
implementations is managed by the bridge 4220, e.g. device
configuration settings, firmware images, status information
etc.
[0404] Device to Bridge 4220 interface protocol: The bridge 4220
supports a MVS apparatus 4104 to bridge 4220 interface protocol,
BRIP, for all communications between the MVS apparatus 4104 and the
bridge 4220 device. Each device supports a single interface
protocol, BRIF and individual device or manufacture level protocols
can be supported by the bridge 4220.
[0405] Network communications method: The bridge 4220 supports a
LAN based interface for processing connection requests and data
transfers from remote MVS apparatus 4104. 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 system 4200 in some implementations support other
transfer methods such as UDP. Where more than one MVS apparatus
4104 type is supported in EMR data capture system 4200 the bridge
4220 supports different transfer mechanism concurrently MVS
apparatus 4104: The bridge 4220 in some implementations accept
connections and measurement data records from MVS apparatus
4104.
[0406] Non-conforming MVS apparatus: The bridge 4220 in some
implementations accepts connections and measurement data records
from non-MVS system using device interface protocols specific to a
given device or manufacture of a range of device. The EMR data
capture system 4200 support third party MVS apparatus 4104 to
provide the same core features and functions as those outlined in
this document. In some implementations, a core system supports all
MVS apparatus 4104 connected to EMR data capture system 4200, 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 4244, along with per device
configuration and status monitoring.
[0407] Single Vital-sign Measurement Data: The bridge 4220 in some
implementations accept and processes for transfer to the configured
EMR/Clinical Data Repository 4244, 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
4104 that supports a single biological vital sign reading.
[0408] Multiple Vital-sign Measurement Data: The bridge 4220 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.
[0409] Continuous Vital-sign Measurement Data: The bridge 4220 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.
[0410] Unique MVS smartphone system identification: The bridge 4220
supports a unique identifier per MVS apparatus 4104, across all
vendors and device types, for the purposes of device
identification, reporting and operations. Each MVS apparatus 4104
that is supported by the EMR data capture system 4200 provides a
unique identification based on the manufacture, product type, and
serial number or other factors such as the FDA UID. The bridge 4220
is required to track, take account of, and report this number in
all interactions with the MVS apparatus 4104 and for logging. This
device identification can also be used in the authentication
process when a MVS apparatus 4104 connects to the bridge 4220.
[0411] Device connection authentication: The bridge 4220 provides a
mechanism to authenticate a given MVS apparatus 4104 on connection
to ensure that the MVS apparatus 4104 are known and allowed to
transfer information to the bridge 4220. Access to the bridge 4220
functions in some implementations is controlled in order to
restrict access to currently allowed devices only. Acceptance of a
MVS apparatus 4104 making connection the bridge 4220 for 2 main
rationales. The MVS apparatus 4104 are known to the bridge 4220,
and that 2. A management function to control access for a given
device, i.e. allow or bar access.
[0412] Last connection of device: The bridge 4220 is required
maintain a history of the connection dates and times for a given
MVS apparatus 4104. This is required from a reporting and logging
viewpoint. In some implementations will also be used to determine
if a MVS apparatus 4104 are lost/stolen or failed.
[0413] Calibration/Checker Monitoring: The bridge 4220 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 4104 in some
implementations be checked for operation and accuracy on a regular
bases. EMR data capture system 4200 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 4220 is on the expiry date exposed by the MVS
apparatus 4104. The bridge 4220 is not required to check the MVS
apparatus 4104 for calibration, only report if the MVS apparatus
4104 are out of calibration based on the MVS apparatus 4104 expiry
date. In some implementations the expiry date is updated at the
time of the MVS apparatus 4104 recalibration check.
[0414] Error/Issue monitoring: The bridge 4220 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 4104.
[0415] Battery Life monitoring: The bridge 4220 is required to
track the battery level of a given device and report the battery
level information to the operator. EMR data capture system 4200 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 4104. It is the MVS apparatus 4104
responsibility to determine its own internal power source charge
level or battery condition. The bridge 4220 can provide a mechanism
to report the known battery condition for all devices, e.g. say all
devices that have 10% battery level remaining.
[0416] Lost/Stolen/Failed monitoring: The bridge 4220 is required
to determine for a given MVS apparatus 4104 if it has been
lost/stolen/or failed and disable the MVS apparatus 4104 for system
operation. Being able to determine if a system has not connected to
the bridge 4220 for a period of time is a feature for failed, lost
or stolen reporting to the operator. If a MVS apparatus 4104 has
not connected to EMR data capture system 4200 for a period of time,
EMR data capture system 4200 determines that the MVS apparatus 4104
has been stolen or lost, in this event the operator is informed in
terms of a system report and the MVS apparatus 4104 removed from
the supported devices list. If and when the MVS apparatus 4104
reconnects to EMR data capture system 4200 the MVS apparatus 4104
are to be lighted as "detected" and forced to be rechecked and
re-commissioned again for use on the network.
[0417] 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.
[0418] 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.
[0419] Dynamic Device Parameter Configuration: The bridge 4220
provides a mechanism to provide configuration information to a MVS
apparatus 4104 when requested by the MVS apparatus 4104 on
connection to the bridge 4220 or via the keep device alive
mechanism. Upon connecting to a bridge 4220 a MVS apparatus 4104 as
part of the communications protocol determines if its current
configuration is out of date, if any aspect of the MVS apparatus
4104 configuration is out of date and is required to be updated
then the bridge 4220 provides the current configuration information
for the MVS apparatus 4104 model and revision This is intended to
be as simple as the MVS apparatus 4104 getting the configuration
setting for each of its supported parameters. The bridge 4220 is
responsible to ensure that the supplied information is correct for
the MVS apparatus 4104 model and revision level.
[0420] Device Configuration Grouping: Single device: The bridge
4220 provides a mechanism to configure a single device, based on
unique device ID, to known configuration parameters. The bridge
4220 in some implementations allows a single MVS apparatus 4104 to
be updated when it connects to the bridge 4220 either via the heart
beat method or via operator use. This effectively means that the
bridge 4220 provides a method to manage and maintain individual
device configuration settings and have those settings available
dynamically for when the MVS apparatus 4104 connects. Further the
bridge 4220 supports per device configurations for different
revisions of device firmware, for example revision 1 of the MVS
apparatus 4104 has configuration parameters x, y and z, but
revision 2 of the MVS apparatus 4104 has configuration parameters
has x, y, z and k and the valid allowed range for the y parameter
has been reduced.
[0421] Device Configuration Grouping--MVS apparatus 4104 model
group: The bridge 4220 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.
[0422] Device Configuration Grouping--selected group within model
range: The bridge 4220 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 4220
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.
[0423] Device Configuration files: The bridge 4220 provides a
method to save, load, update and edit a configuration file for a
MVS apparatus 4104 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
system 4200. A file management mechanism in some implementations is
also provided for the saved configuration files.
[0424] Dynamic configuration content: The bridge 4220 in some
implementations dynamically per MVS apparatus 4104 connection
determine upon request by the MVS apparatus 4104 the new
configuration settings for that device, given that the medical
devices connect in a random manner to the bridge 4220, the bridge
4220 is required for the connected device, model, revision, unique
identification etc. to maintain the configuration settings for that
device.
[0425] The bridge 4220 provides a mechanism to control the patient
record received from a MVS apparatus 4104 to transfer the record to
one or more of the supported EMR/Clinical Data Repository 4244.
Where more than one EMR/Clinical Data Repository 4244 is maintained
by a single organization, e.g. one for ER, cardiology use and
possibility one for outpatients etc. EMR data capture system 42
4200 in some implementations manage either by specific device
configuration or bridge 4220 configuration which EMR the patient
record is to be transmitted to by the bridge 4220.
[0426] Device Configuration and Status Display: In some
implementations, when a MVS apparatus 4104 connects to the bridge
4220 that the MVS apparatus 4104 queries its current configuration
settings against the bridge 4220 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 system 4200. 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 4104, updated with the same settings. Bridge 4220
device configuration options adjusted based on MVS apparatus 4104.
The bridge 4220 in some implementations adjusts the configuration
options presented to the operator based on the capabilities of the
MVS apparatus 4104 being configured. Where multiple different MVS
apparatus 4104 are supported by the EMR data capture system 4200 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 4220 in some
implementations determine the configuration capabilities for the
MVS apparatus 4104 to be configured and present only valid
configuration options for that device with valid parameter ranges
for these options.
[0427] Device parameter Validation: The bridge 4220 provides a
mechanism for a given model MVS apparatus 4104 to validate that a
given configuration parameter is set within valid parameter ranges
for that device model and revision. The bridge 4220 is required
based on the MVS apparatus 4104 model and revision level to present
valid parameter ranges fo