U.S. patent application number 13/697022 was filed with the patent office on 2013-10-24 for fluids testing apparatus and methods of use.
This patent application is currently assigned to LABSTYLE INNOVATION LTD.. The applicant listed for this patent is Eyal Cohen, Oren Fuerst, Dov Oppenheim, Meir Plevinski, David Weintraub. Invention is credited to Eyal Cohen, Oren Fuerst, Dov Oppenheim, Meir Plevinski, David Weintraub.
Application Number | 20130276521 13/697022 |
Document ID | / |
Family ID | 44914772 |
Filed Date | 2013-10-24 |
United States Patent
Application |
20130276521 |
Kind Code |
A1 |
Fuerst; Oren ; et
al. |
October 24, 2013 |
FLUIDS TESTING APPARATUS AND METHODS OF USE
Abstract
The invention is directed to a mobile hand held miniature
laboratory system in general, and to fluid testing apparatus for
performing a parameter measurement in a fluid sample and methods of
use thereof in particular. The apparatus comprising: A strip
adapted to absorb a fluid sample and to produce a signal indicative
of said parameter level in said sample; and an adaptor adapted to
connect said strip to a smart phone to thereby allow delivery of
the produced signal or a correlated signal to said smart phone for
obtaining a measurement of said fluid parameter displayed on said
smart phone, wherein said testing apparatus relies on said smart
phone at least for power supply and display means.
Inventors: |
Fuerst; Oren; (Ramat
Hasharon, IL) ; Weintraub; David; (Yavne, IL)
; Oppenheim; Dov; (Jerusalem, IL) ; Plevinski;
Meir; (Tel-Aviv, IL) ; Cohen; Eyal; (Gedera,
IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Fuerst; Oren
Weintraub; David
Oppenheim; Dov
Plevinski; Meir
Cohen; Eyal |
Ramat Hasharon
Yavne
Jerusalem
Tel-Aviv
Gedera |
|
IL
IL
IL
IL
IL |
|
|
Assignee: |
LABSTYLE INNOVATION LTD.
Ramat-Gan
IL
|
Family ID: |
44914772 |
Appl. No.: |
13/697022 |
Filed: |
May 8, 2011 |
PCT Filed: |
May 8, 2011 |
PCT NO: |
PCT/IL11/00369 |
371 Date: |
January 14, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61431449 |
Jan 11, 2011 |
|
|
|
61332778 |
May 9, 2010 |
|
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Current U.S.
Class: |
73/61.59 |
Current CPC
Class: |
A61B 2562/0295 20130101;
G01N 33/66 20130101; G01N 33/487 20130101; H01R 2201/20 20130101;
G01N 33/48785 20130101; G01N 33/49 20130101; G01N 33/493 20130101;
G08C 19/00 20130101; A61B 2560/0487 20130101; H01R 2107/00
20130101; A61B 2560/045 20130101; A61B 5/6898 20130101; A61B 5/0004
20130101; H04M 2250/12 20130101; H04M 1/21 20130101; H01R 24/58
20130101; A61B 5/14532 20130101 |
Class at
Publication: |
73/61.59 |
International
Class: |
G01N 33/487 20060101
G01N033/487; G01N 33/493 20060101 G01N033/493; G01N 33/49 20060101
G01N033/49 |
Claims
1-50. (canceled)
51. A fluid testing apparatus for performing a parameter
measurement in a fluid sample comprising: a. a strip adapted to
absorb a fluid sample and to produce a signal indicative of said
parameter level in said sample; and b. an adaptor adapted to
connect said strip to a mobile device to thereby allow delivery of
the produced signal or a correlated signal to said mobile device
for obtaining a measurement of said fluid parameter displayed on
said mobile device, wherein said testing apparatus is adapted to
obtain at least a display means from said mobile device.
52. The fluid testing apparatus according to claim 51, wherein said
fluid testing apparatus is adapted such that at least one of the
following is true: a. said produced signal or a correlated signal
is processed at least partially by said fluid testing apparatus
before delivery to said mobile device; and b. said produced signal
or a correlated signal is delivered to said mobile device for
processing by a dedicated application software installed on said
mobile device.
53. The fluid testing apparatus according to claim 52, wherein said
processing is conducted by reading the peak and timing of peak of a
current of a voltage signal obtained upon loading the fluid sample
on said strip.
54. The fluid testing apparatus according to claim 51, wherein at
least one of the following is true: a. said adaptor comprises an
electrical circuit adapted to allow communication between the strip
inner circuit and a connecting plug adapted to allow delivery of
the produced signal or a correlated signal to said mobile device;
b. said adaptor further comprises a micro control unit adapted to
perform at least partial processing of said signal prior to
delivery of said signal to said mobile device; c. said fluid
testing apparatus is adapted such that upon delivery of said signal
or a correlated signal to said mobile device, processing of said
signal is performed by dedicated application software installed on
said mobile device, and wherein a measurement is displayed on said
mobile device; and said testing apparatus is adapted to obtain at
least a power supply from said mobile device.
55. The fluid testing apparatus according to claim 51, wherein said
apparatus is adapted to be provided with storage of data and
communication by said mobile device.
56. The fluid testing apparatus according to claim 51, wherein said
strip is either one of a chemical strip or an electrochemical
strip, and wherein said signal transferred to said mobile device by
electric current signal or voltage signal.
57. The fluid testing apparatus according to claim 51, wherein said
fluid is a physiological fluid, and wherein said fluid sample is
either one of a blood sample, a urine sample, an amniotic fluid
sample, and a saliva sample, or a mixture thereof.
58. The fluid testing apparatus according to claim 51, wherein said
parameter measurement is one selected from the group comprising of
a glucose level, cholesterol level, HbAlC level, Hemoglobin level,
fetal lung maturation level, PSA level or a toxic substance.
59. The fluid testing apparatus according to claim 51, wherein said
apparatus comprises two separable subunits, first subunit comprises
a lancing device and housing; and second subunit comprises a slot
adapted to allow collection of said physiological fluid sample, a
strip, an adaptor to thereby allow physical attachment and signals
transmission between said testing apparatus and said mobile device,
and housing.
60. The fluid testing apparatus according to claim 59, wherein the
length of said lancet is adjustable to functionally allow a user to
adapt said lancet length to his physical dimensions.
61. The fluid testing apparatus according to claim 51, wherein said
apparatus is provided with a connecting plug or audio jack that is
functionally adapted to be inserted into said mobile device via the
audio jack port to thereby obtain at least a power supply or
display means from said mobile device.
62. The fluid testing apparatus according to claim 51, wherein said
a signal indicative of said parameter level is delivered to said
mobile device via the audio jack port.
63. The fluid testing apparatus according to claim 62, wherein any
of said strip, said lancet said first subunit, said second subunit
and said apparatus is disposable.
64. The fluid testing apparatus according to claim 51, wherein said
apparatus is functionally connectable to said mobile device via a
USB entry to thereby obtain at least a power supply or display
means from said mobile device.
65. The fluid testing apparatus according to claim 51, wherein said
a signal indicative of said parameter level is delivered to said
mobile device via a USB entry or wirelessly.
66. The fluid testing apparatus according to claim 51, wherein said
adaptor is adapted to connect said strip to said mobile device
selected from the group comprising of smart phone, tablet, iPad,
laptop Android or an iPod.
67. The fluid testing apparatus according to claim 51, wherein said
apparatus is provided with a Micro processing Unit (MCU) that
functionally allows said apparatus to receive commands from said
mobile device via the speaker output pin.
68. The fluid testing apparatus according to claim 51, wherein at
least one of the following is true: a. said adaptor comprises an
electrical circuit adapted to allow communication between the strip
inner circuit and a connecting plug adapted to allow delivery of
the produced signal or a correlated signal to said mobile device;
b. said adaptor further comprises a micro control unit adapted to
perform at least partial processing of said signal prior to
delivery of said signal to said mobile device; c. said fluid
testing apparatus is adapted such that upon delivery of said signal
or a correlated signal to said mobile device, processing of said
signal is performed by dedicated application software installed on
said mobile device, and wherein a measurement is displayed on said
mobile device; and d. said testing apparatus is adapted to obtain
at least a power supply from said mobile device.
69. The fluid testing apparatus according to claim 68, wherein said
adaptor is adapted to connect said strip to said mobile device
selected from the group comprising of smart phone, tablet, iPad,
laptop, Android or an iPod.
70. A fluid testing apparatus for performing a parameter
measurement in a fluid sample comprising: a. a strip adapted to
absorb a fluid sample and to produce a signal indicative of said
parameter level in said sample; and b. an adaptor adapted to
connect said strip to a mobile device to thereby allow delivery of
the produced signal or a correlated signal to said mobile device
for obtaining a measurement of said fluid parameter displayed on
said mobile device, wherein said testing apparatus is adapted to
obtain at least a display means from said mobile device and is
connected thereto by said adaptor audio jack to audio port of said
mobile device.
71. The fluid testing apparatus according to claim 70, wherein said
fluid testing apparatus is adapted such that at least one of the
following is true: a. said produced signal or a correlated signal
is processed at least partially by said fluid testing apparatus
before delivery to said mobile device; and b. said produced signal
or a correlated signal is delivered to said mobile device for
processing by a dedicated application software installed on said
mobile device.
72. A method for performing a fluid parameter measurement in a
fluid sample comprising steps of: a. installing a dedicated
application software on a mobile device; b. loading a fluid sample
on a fluid testing apparatus, said apparatus comprising: a strip
adapted to absorb said sample and to produce a signal indicative of
said parameter level in said sample; and an adaptor adapted to
connect said strip to a mobile device to thereby allow delivery of
the produced signal or a correlated signal to said mobile device
for obtaining a measurement of said fluid parameter displayed on
said mobile device; c. inserting said loaded fluid testing
apparatus to allow communication between said apparatus and said
mobile device; and d. obtaining the measured parameter level
displayed on said mobile device screen, wherein said step of
inserting is into the audio jack port of a mobile device.
73. The method according to claim 72, wherein said testing
apparatus is adapted to obtain at least a power supply and display
means from said mobile device.
74. The method according to claim 72, wherein said fluid testing
apparatus is adapted such that at least one of the following is
true: a. said produced signal or a correlated signal is processed
at least partially by said fluid testing apparatus before delivery
to said mobile device; and b. said produced signal or a correlated
signal is delivered to said mobile device for processing by a
dedicated application software installed on said mobile device.
Description
FIELD OF THE INVENTION
[0001] The present invention is generally related to a novel
disposable apparatus adapted to allow the performance of various
fluids test in order to measure the level of different parameters
in such fluid in general, and to perform various physiological
fluids test such as urine, blood, amniotic fluid, and saliva in
particular, in an easy friendly and inexpensive way, by symbiotic
relations of a special apparatus with a smart phone ("Symbiotronic"
relation).
BACKGROUND ART
[0002] The following references may be relevant as a background art
to the present invention:
U.S. Patent Ap. 20080299009; US2006260940; U.S. Pat. No. 7,810,729;
Qi Li, Jingqi Yuan, Proceedings of the 2005 IEEE, Engineering in
Medicine and Biology 27th Annual Conference, Shanghai, China, Sep.
1-4, 2005; www.alivetec.com, Mobile Diabetes Management;
www.entrahealthsystems.com MyGlucoHealth Diabetes App;
www.bodytel.com; www.myglucometer.com; www.bayercontourusb.us;
https://my.glucophone.com/runscript.cfm?page=home.cfm;
https://sites.google.com/site/glucosemeterandroid;
http://www.androlib.com/android.application.com-fjbelchi-glucosemeter-Aqm-
x.aspx
SUMMARY OF THE INVENTION
[0003] This summary section of the patent application is intended
to provide an overview of the subject matter disclosed herein, in a
form lengthier than an "abstract", and should not be construed as
limiting the disclosure to any features described in this summary
section.
[0004] The present invention is aimed to provide a novel fluid
testing apparatus for performing a parameter measurement in a fluid
sample comprising: A strip adapted to absorb a fluid sample and to
produce a signal indicative of the parameter level in the sample;
and an adaptor adapted to connect said strip to a smart phone to
thereby allow delivery of the produced signal or a correlated
signal to said smart phone for obtaining a measurement of said
fluid parameter displayed on said smart phone, wherein said testing
apparatus relies on said smart phone at least for power supply and
display means.
[0005] It is also the aim of the present invention to provide a
novel physiological fluid testing apparatus for performing a
parameter measurement in a fluid sample comprising: a strip adapted
to absorb a physiological fluid sample and to produce a signal
indicative of said parameter level in said sample; and an adaptor
adapted to connect said strip to a smart phone to thereby allow
delivery of the produced signal or a correlated signal to said
smart phone for obtaining a measurement of said fluid parameter
displayed on said smart phone, wherein said physiological fluid
testing apparatus relies on said smart phone at least for power
supply and display means.
[0006] The present invention is further aimed to provide a blood
testing apparatus for performing glucose measurement in a blood
sample comprising: a glucose strip adapted to absorb a blood sample
and to produce a signal indicative of the glucose level in said
blood sample; and an adaptor adapted to connect said glucose strip
to a smart phone to thereby allow delivery of the produced signal
or a correlated signal to said smart phone for obtaining a
measurement of the glucose level displayed on said smart phone,
wherein said blood testing apparatus relies on said smart phone at
least for a power supply and display means.
[0007] The present invention is further directed to a method for
performing glucose measurement in a blood sample comprising the
steps of: Installing a dedicated application software on a smart
phone; Loading a blood sample on a glucose measurement apparatus,
said apparatus comprising: a strip adapted to absorb blood sample
and to produce a signal indicative of said glucose level in said
sample; and an adaptor adapted to connect said strip to a smart
phone to thereby allow delivery of the produced signal or a
correlated signal to said smart phone for obtaining a measurement
of said glucose level displayed on said smart phone, wherein said
glucose measurement apparatus relies on said smart phone at least
for a power supply and display means; Inserting said loaded glucose
measuring apparatus into a headset jack of a smart phone to thereby
allow communication between said apparatus and said smart phone and
delivery of power supply; and, obtaining the measured glucose level
displayed on said smart phone screen.
[0008] The present invention further provides a blood glucose
monitoring apparatus for determining glucose level in a blood
sample of a user comprising: a lancing device adapted to allow said
user obtaining a blood sample; a slot adapted to allow collection
of said blood sample; a glucose strip adapted to absorb said blood
sample and to produce a signal indicative of said glucose level in
said sample; an adaptor adapted to functionally connect said
glucose strip to a smart phone via a connecting plug designed to be
inserted into a headset jack of a smart phone to functionally
deliver to said smart phone the produced signal or a correlated
signal thereof, and to allow said apparatus obtain at least a power
supply and display means from said smart phone.
[0009] The invention is further aimed to provide a mobile miniature
laboratory system capable of performing fluid parameter measurement
of a sample, said system comprising: A smart phone installed with a
dedicated application software; A strip adapted to absorb a fluid
sample and to produce a signal indicative of said parameter level
in said sample; An adaptor adapted to connect said strip to a smart
phone to thereby allow delivery of the produced signal or a
correlated signal to said smart phone for obtaining a measurement
of said fluid parameter displayed on said smart phone, wherein said
testing apparatus relies on said smart phone at least for a power
supply and display means.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] It should be clear that the description of the embodiments
and attached Figures set forth in this specification serves only
for a better understanding of the invention, without limiting its
scope. It should also be clear that a person skilled in the art,
after reading the present specification could make adjustments or
amendments to the attached Figures and above described embodiments
that would still be covered by the present invention. In the
figures, identical structures, elements or parts that appear in
more than one figure are generally labeled with the same numeral in
all the figures in which they appear. Dimensions of components and
features shown in the figures are generally chosen for convenience
and clarity of presentation and are not necessarily shown to scale.
Many of the figures presented are in the form of schematic
illustrations and, as such, certain elements may be drawn greatly
simplified or not-to-scale, for illustrative clarity. The figures
are not intended to be production drawings. The figures (Figs.) are
listed below.
[0011] FIG. 1 is a schematic top view illustration of a
physiological fluid testing apparatus (hereinafter: "PFTA") in
accordance with variations of the present invention that is
functionally adapted to perform blood tests.
[0012] FIG. 2 is an upper front view illustration of PFTA 100 of
FIG. 1 in a detached position.
[0013] FIG. 3 is a schematic "bomb view" illustration of subunit
102 of PFTA 100 of FIG. 1 showing all the components comprised in
subunit 102 in accordance with variations of the invention.
[0014] FIG. 4 is a schematic illustration of another variation of
physiological fluid testing apparatus in accordance with the
present invention that is functionally adapted to perform blood
tests. FIG. 4A is an upper front view illustration of PFTA 400 in a
packed form made of two subunits; FIG. 4B is an upper front view of
first subunit 402 of PFTA 400; FIG. 4C is an upper front view of
second subunit 404 of PFTA 400.
[0015] FIG. 5 is a schematic illustration of an optional operation
mode of PFTA 100 or PFTA 400 adapted to measure glucose level in
the blood, in accordance with variations of the present invention
(FIG. 5A), and two optional measurement circuits that may be used
in such operation mode: A proposed measurement circuit with long
recording time (FIG. 5B); and, a proposed measurement circuit with
short recording time (FIG. 5C).
[0016] FIG. 6 is a schematic illustration of another optional
measurement circuit of PFTA 100 or PFTA 400 adapted to measure
glucose level in the blood in accordance with variations of the
present invention.
[0017] FIG. 7 is a schematic is a schematic illustration of a basic
Chrip signal that smart phone generates in order to make glucose
analysis from a chemical strip in accordance with variations of the
present invention.
[0018] FIG. 8 is a graphic illustration of differentiator output
voltage vs. strip current, in accordance with variations of the
present invention.
[0019] FIG. 9 is a graphic illustration of 100 Hz speaker signal
vs. glucose level of 48 mg/dL (8A); 198 mg/dL (8B); and 393 mg/dL
(8C) in accordance with the present invention as described in FIG.
5C.
[0020] FIG. 10 is a schematic functional block diagram of the PFTA
100 of FIG. 1, and a smart phone in accordance with variation of
the invention.
[0021] FIG. 11 is a graphic illustration of typical current values
generated by a glucose strip following a chemical or an
electrochemical reaction.
[0022] FIG. 12 is a graphic illustration of typical sinus wave
generated by a speaker of a smart phone for it to be recorded by
the smart's phone microphone as a baseline waveform.
[0023] FIG. 13 is a graphic illustration of a strip current (top
part) and a microphone recorded waveform (bottom part) for three
distinct glucose values 48 mg/dL (13A), 189 mg/dL (13B), and 393
mg/dL (13C) in accordance with variations of the invention as
described in FIG. 5B.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0024] In the following description, various aspects of a novel
fully disposable apparatus adapted to allow performance of various
fluids test such as toxicity tests in industrial pools and
entertainment instruments such as swimming pool and to allow
various physiological fluids test such as urine, blood, amniotic
fluid, and saliva in an easy and friendly manner will be described.
The novel disposable apparatus described herein is functionally
connected to a smart phone installed with dedicated application
software and relies on said smart phone at least for a power source
and display means, and to transmit signals indicative of the
measured parameter to said smart phone in a symbiotronic manner.
The term "symbiotronic" as used herein is aimed to describe a
symbiotic electrical relationship between the novel apparatus of
the invention and a smart phone to form an all new device, such as
a Glucometer. In order to allow, said symbiotronic relations and to
perform various physiological fluid tests, dedicated application
software is preinstalled on the smart phone that allows
transformation of a measured level of a specific parameter in a
physiological fluid sample obtained by a chemical reaction on a
commercial strip, into a displayed number or other indicative
symbol on the smart phone screen. Analysis of the data obtained
from the commercial strip may be performed either on the disposable
apparatus, or on the smart phone or on both, as will be described
in details hereinafter. For the purpose of explanation, specific
configurations and details are set forth in order to provide a
thorough understanding of the apparatus.
[0025] Although various features of the disclosure may be described
in the context of a single embodiment, the features may also be
provided separately or in any suitable combination. Conversely,
although the disclosure may be described herein in the context of
separate embodiments for clarity, the disclosure may also be
implemented in a single embodiment. Furthermore, it should be
understood that the disclosure can be carried out or practiced in
various ways, and that the disclosure can be implemented in
embodiments other than the exemplary ones described herein below.
The descriptions, examples and materials presented in the
description, as well as in the claims, should not be construed as
limiting, but rather as illustrative.
[0026] Terms for indicating relative direction or location, such as
"right" and "left", "up" and "down", "top" and "bottom",
"horizontal" and "vertical", "higher" and "lower", and the like,
may also be used, without limitation.
[0027] In accordance with embodiments of the present invention the
novel apparatus provided herein may be used to perform various
fluid test such as toxicity tests, and various biological tests
produced from physiological fluids such as blood, urine, amniotic
fluid, or saliva, such as glucose level, cholesterol level,
coagulation test, pregnancy test (in blood or urine), HIV test, PH
test, fetal lung maturation test, and more. The apparatus is
preferably a small size fully disposable apparatus. It may be made
of one unit or more. The apparatus is functionally connected to a
smart phone and may rely on the phone for power supply, display
means, storage and communication for operation. The electrical
connection between the apparatus and the smart phone may be
established by a connector from any kind known in the art and that
is suitable for this purpose (Ear phone plug, USB, or other).
[0028] The apparatus provided herein is connected to a smart phone
in a complementary manner, as the combination of the two together
with specific software installed on the smart phone provides a
novel system capable of performing various physiological fluids
tests in a user friendly, fully disposable, and inexpensive manner.
In addition, the apparatus may communicate besides of a cell phone
or a Wi-Fi based phone, with any mobile device with a computing
power such as an iPod or iPad, and it is may also communicate with
any other tablet devices. Similarly, the novel apparatus provided
herein may communicate with any computing devices such as a
Laptop.
[0029] Wikipedia defines smart phone as the following: "A smart
phone is a mobile phone that offers more advanced computing ability
and connectivity than a contemporary basic feature phone. Smart
phones and feature phones may be thought of as handheld computers
integrated within a mobile telephone, but while most feature phones
are able to run applications based on platforms such as Java ME, a
smart phone usually allows the user to install and run more
advanced applications. According to a study by ComScore, over 45.5
million people in the United States owned smart phones in 2010 and
it is the fastest growing segment of the mobile phone market, which
comprised 234 million subscribers in the United States. Thus, by
using a smart phone as a platform for example for performing
various fluid test in combination with the novel fully disposable
apparatus of the present invention, as an hand held miniature
mobile laboratory, it may provide mass of people worldwide an
opportunity to easily monitor and follow up various physiological
parameters including without limitation, glucose levels,
cholesterol levels, hemoglobin level etc., without the need to go
to the doctor and without the need to go to a laboratory in order
to performs such biological tests and to wait usually few days
until they have the results. In addition, the proposed platform and
the novel apparatus provided herein, allow many diabetic people
worldwide, that should monitor their glucose level in a daily
manner a simple, friendly, fully disposable, and minimally
burdening platform to do this compared with currently available
Glucometers (both, transplanted glucose monitoring systems and non
transplanted systems). Furthermore, according to the international
Diabetes federation (www.idf.org) much of the population in
developing countries is not being followed properly in light of the
costs and the logistics of the currently available devices and
their analysis. The proposed platform together with the novel
apparatus provided herein may solve this problem and provide a
simple, non expensive and easy to perform solution.
[0030] In accordance with features of the invention, for testing a
blood sample the apparatus may comprise the general following
components: a lancing device to sample blood from a finger, forearm
or palm of a user; an electrochemical strip, such as a glucose
strip or a cholesterol strip adapted to collect blood sample and to
produce data; and an electrical circuit that is functionally
adapted to receive the data produced by said electrochemical strip
and translate the chemical results into an electronic signal
(analog or digital) that is, preferably, transmitted to a smart
phone, either by wire or wireless transmission. Data transmission
from the apparatus of the invention to a smart phone may be
performed either by physical attachment of the two, for example by
plugging the apparatus into the headset jack of the smart phone.
Alternatively, it may be transmitted in a wireless mode in any form
known in the art (e.g. Bluetooth, infra red, radio frequency,
sound, RFID etc.).
[0031] For testing a urine sample, saliva sample or amniotic fluid
sample the apparatus may comprise an electrochemical or chemical
strip adapted to absorb the liquid sample and to produce data, and
an electric circuit that is functionally adapted to receive the
data produced by said electrochemical or chemical strip and
translate the chemical results into an electronic signal (analog or
digital) that is preferably, transmitted to a smart phone.
[0032] The electrochemical or chemical strip could be test-specific
strips (for example glucose strip, cholesterol strip, pregnancy
strip, protein strip, etc.)
[0033] In accordance with one feature of the present invention, a
fluid testing apparatus for performing parameter measurement in a
fluid sample is provided. The apparatus comprises: a strip adapted
to absorb a fluid sample and to produce a signal indicative of said
parameter level in said sample; and an adaptor adapted to connect
said strip to a smart phone to thereby allow delivery of the
produced signal or a correlated signal to said smart phone for
obtaining a measurement of said fluid parameter displayed on said
smart phone, wherein said testing apparatus relies on said smart
phone at least for power supply and display means. The produced
signal or a correlated signal may be processed at least partially
by said fluid testing apparatus before delivery to said smart
phone. Alternatively, the produced signal or a correlated signal
may be delivered to said smart phone for processing by a dedicated
application software installed on said smart phone. In accordance
with one variation, processing may be conducted by reading the peak
and timing of peak of a current of a voltage signal obtained upon
loading the fluid sample on said strip. The adaptor may comprise an
electrical circuit adapted to allow communication between said
strip inner circuit and a connecting plug adapted to allow delivery
of the produced signal or a correlated signal to said smart phone.
The adaptor may further comprise a micro control unit and may be
adapted to perform at least partial processing of said signal prior
to delivery of said signal to said smart phone. Upon delivery of
said signal or a correlated signal to the smart phone, processing
of said signal is performed by dedicated application software
installed on said smart phone, and a measurement is being displayed
on said smart phone. In accordance with a further variation of the
invention, the apparatus further relies on said smart phone for
storage of data and communication. The measured parameter in
accordance with variation of the invention may be a toxic
substance.
[0034] In accordance with the present invention, the strip may be
either one of a chemical strip or an electrochemical strip, and the
signal transferred to the smart phone is either an electric current
signal or a voltage signal.
[0035] The fluid sample may also be a physiological fluid, such as
a blood sample, a urine sample, an amniotic fluid sample, and a
saliva sample, or a mixture thereof. In such variation, the
measured parameter may be for example, a glucose level, cholesterol
level, HbAlC level, Hemoglobin level, fetal lung maturation level,
and PSA level. In a specific variation of the invention, the
apparatus is adapted to perform blood tests and comprises at least
two separable subunits, first subunit comprises at least: a lancing
device and housing; and second subunit comprises at least: a slot
adapted to allow collection of said physiological fluid sample, a
strip, an adaptor to thereby allow physical attachment and signals
transmission between said testing apparatus and said smart phone,
and housing. In such variation, the apparatus may further comprise
a thread that functionally allows a user to adapt said lancet
length to his physical dimensions.
[0036] The apparatus provided herein may functionally be connected
to said smart phone either via the headset jack or via a USB entry
to thereby obtain at least a power supply and display means from
said smart phone. The signal indicative of said parameter level may
be delivered to the smart phone either via the headphone jack or
via a USB entry, or it may be transmitted wirelessly. The apparatus
is preferably fully disposable. In accordance with one another
variation the apparatus may be connected and rely on a tablet
device (such as iPad) or an iPod instead of a smart phone.
[0037] The present invention further provides a physiological fluid
testing apparatus for performing a parameter measurement in a fluid
sample comprising: A strip adapted to absorb a physiological fluid
sample and to produce a signal indicative of said parameter level
in said sample; An adaptor adapted to connect said strip to a smart
phone to thereby allow delivery of the produced signal or a
correlated signal to said smart phone for obtaining a measurement
of said fluid parameter displayed on said smart phone, wherein said
physiological fluid testing apparatus relies on said smart phone at
least for power supply and display means. The produced signal or a
correlated signal may be processed at least partially by said
testing apparatus before delivery to said smart phone.
Alternatively, the produced signal or a correlated signal may be
delivered to the smart phone for processing by dedicated
application software installed on said smart phone. The fluid
sample in such variation may be either one of a blood sample, a
urine sample, an amniotic fluid sample, a saliva sample, or a
mixture thereof, and wherein, said measured parameter is either one
of a glucose level, cholesterol level, HbAlC level, Hemoglobin
level, fetal lung maturation level, and PSA level. The apparatus is
preferably fully disposable. In one another variation, it may be
connected and rely on a tablet device (such as iPad) or an iPod
instead of a smart phone.
[0038] In one further variation of the invention, a blood testing
apparatus for performing glucose measurement in a blood sample is
provided. The apparatus comprising: A glucose strip adapted to
absorb a blood sample and to produce a signal indicative of the
glucose level in said blood sample; and an adaptor adapted to
connect said glucose strip to a smart phone to thereby allow
delivery of the produced signal or a correlated signal to said
smart phone for obtaining a measurement of the glucose level
displayed on said smart phone, wherein said blood testing apparatus
relies on said smart phone at least for a power supply and display
means. In such variation, the produced signal or a correlated
signal is being processed at least partially by said blood testing
apparatus before delivery to said smart phone. Alternatively, the
produced signal or a correlated signal is delivered to said smart
phone for processing by a dedicated application software installed
on said smart phone. Processing may be conducted by reading the
peak and timing of peak of a current or a voltage signal obtained
upon loading the blood sample on said glucose strip. In such
variation, the apparatus is preferably fully disposable. In one
another variation, the apparatus may be connected and rely on a
tablet device (such as iPad) or an iPod instead of a smart
phone.
[0039] The invention is further directed to a method for performing
a fluid parameter measurement in a fluid sample comprising the
steps of: Installing a dedicated application software on a smart
phone; Loading a fluid sample on a fluid testing apparatus, said
apparatus comprising: a strip adapted to absorb such sample and to
produce a signal indicative of said parameter level in said sample;
and an adaptor adapted to connect said strip to a smart phone to
thereby allow delivery of the produced signal or a correlated
signal to said smart phone for obtaining a measurement of said
fluid parameter displayed on said smart phone, wherein said testing
apparatus relies on said smart phone at least for a power supply
and display means; Inserting said loaded fluid testing apparatus
into a headset jack of a smart phone to thereby allow communication
between said apparatus and said smart phone and delivery of power
supply; and obtaining the measured parameter level displayed on
said smart phone screen. The loaded fluid testing apparatus may be
connected to said smart phone via a USB entry. The produced signal
may be delivered to the smart phone either via the headset jack,
via a USB entry, or it may be transmitted wirelessly.
Alternatively, the apparatus may be connected and rely on a tablet
device (such as iPad) or an iPod instead of a smart phone. In
accordance with one specific variation, the tested fluid is a
physiological fluid, such as blood, urine, an amniotic fluid,
saliva, or a mixture thereof. The measured parameter may be for
example, a glucose level, cholesterol level, HbAlC level,
Hemoglobin level, fetal lung maturation level, and PSA level. The
strip may be either one of a chemical strip or an electrochemical
strip, and the signal transferred to the smart phone may be either
an electric current signal or a voltage signal. The produced signal
or correlated signal may be processed at least partially by said
fluid testing apparatus before delivery to said smart phone.
Alternatively, the produced signal or a correlated signal may be
delivered to said smart phone for processing by a dedicated
application software installed on said smart phone. In one specific
variation, processing is conducted by reading the peak and timing
of peak of a current of a voltage signal obtained upon loading the
fluid sample on said strip.
[0040] The present invention further provides a method for
performing glucose measurement in a blood sample comprising the
steps of: Installing dedicated application software on a smart
phone; Loading a blood sample on a glucose measurement apparatus,
said apparatus comprising: a strip adapted to absorb blood sample
and to produce a signal indicative of said glucose level in said
sample; and an adaptor adapted to connect said strip to a smart
phone to thereby allow delivery of the produced signal or a
correlated signal to said smart phone for obtaining a measurement
of said glucose level displayed on said smart phone, wherein said
glucose measurement apparatus relies on said smart phone at least
for a power supply and display means; Inserting said loaded glucose
measuring apparatus into a headset jack of a smart phone to thereby
allow communication between said apparatus and said smart phone and
delivery of power supply; and obtaining the measured glucose level
displayed on said smart phone screen. In such variation, the loaded
glucose measurement apparatus may be, alternatively, connected to
said smart phone via a USB entry. The signal produced may be
delivered to said smart phone either via the headset jack, via a
USB entry, or it is transmitted wirelessly. The apparatus is
preferably fully disposable. In one another variation, the
apparatus may be connected and rely on a tablet device (such as
iPad) or an iPod instead of a smart phone.
[0041] The application is further directed to a blood glucose
monitoring apparatus for determining glucose level in a blood
sample of a user comprising: a lancing device adapted to allow said
user obtaining a blood sample; a slot adapted to allow collection
of said blood sample; a glucose strip adapted to absorb said blood
sample and to produce a signal indicative of said glucose level in
said sample; and an adaptor adapted to functionally connect said
glucose strip to a smart phone via a connecting plug designed to be
inserted into a headset jack of a smart phone to functionally
deliver to said smart phone the produced signal or a correlated
signal thereof, and to allow said apparatus obtain at least a power
supply and display means from said smart phone.
[0042] The invention is also directed to a mobile hand held,
miniature laboratory system capable of performing fluid parameter
measurement of a sample, said system comprising: a smart phone
installed with dedicated application software; a strip adapted to
absorb a fluid sample and to produce a signal indicative of said
parameter level in said sample; and an adaptor adapted to connect
said strip to a smart phone to thereby allow delivery of the
produced signal or a correlated signal to said smart phone for
obtaining a measurement of said fluid parameter displayed on said
smart phone, wherein said testing apparatus relies on said smart
phone at least for a power supply and display means. In a specific
variation the fluid sample may be a physiological fluid sample such
as, a blood sample, a urine sample, an amniotic fluid sample, a
saliva sample, or a mixture thereof, and wherein, said measured
parameter is either one of a glucose level, cholesterol level,
HbAlC level, Hemoglobin level, fetal lung maturation level, and PSA
level.
[0043] Reference is now made to the figures.
[0044] FIG. 1 is a schematic top view illustration of a
physiological fluid testing apparatus in accordance with variations
of the present invention that is functionally adapted to perform
blood tests. PFTA 100 illustrated in FIG. 1 is in a packed form and
composed of two subunits 102 and 104. However; it is clear to a man
skilled in the art that such apparatus could be composed of one
subunit only, or alternatively it may be composed of more than two
subunits according to a desired design. First subunit 102 comprises
a housing 122, a slot 140 for collecting a blood sample located at
the distal end of subunit 102 away from subunit 104 and a chemical
strip 150. Slot 140 is preferably but not necessarily made of a
transparent cover 124 that provides the user a convenient view for
indicating whether the blood sample has reached strip 150. First
subunit further comprises an adaptor 180 that comprises an
electrical circuit (not shown) attached to a PCB (printed circuit
board), connecting socket to connect the chemical strip to the PCB,
and a connecting plug 130 such as an audio jack output, that is
functionally adapted to be inserted into an audio jack port of a
smart phone, or other computerized device as mentioned above and
functionally to transmit/deliver the signals obtained from the
strip or correlated signals to the smart phone. Connecting plug 130
may be connected to a plain electric circuit that is aim to allow
communication between connecting plug 130 and strip 150 (and to
deliver a non processed signal), or it may be connected to a
complex electric circuit with a Micro control unit (MCU) that fully
or partially analyzes the signal produced by the strip (and to
deliver a processed signal). The other end of connecting plug 130
that is free is adapted to be inserted into the headset jack of a
smart phone to physically connect subunit 102 to said smart phone
(not shown in this figure). Second subunit 104 generally comprises
a housing 120, a cocking mechanism 133 that is adapted to cock a
lancet upon usage, a lancet trigger 166, and a lancet opening. The
term "lancet" as used herein also refers to a needle. When subunit
102 is connected to subunit 104 cocking mechanism 133 is unable to
function, wherein the connection between the two subunits
functionally serves as a safety mechanism. Subunit 104 may also
comprise a thread 170 that may cover the connection area of subunit
102 and subunit 104 and allows a user to set the lancet length to
be protruded upon pressing the lancet trigger 166. This mechanism
allows a user to adapt it to its physical dimensions. The
attachment of subunit 102 and 104 may be based on structural
fitting of the attached components as shown in FIG. 2. A detailed
description of the functionality of the components mentioned in the
above will be made with reference to FIG. 4 hereinafter. Although
the general structure of PFTA 100 is the same, minor changes may be
made in accordance with the type of fluid tested (urine, blood,
saliva, amniotic fluid, or other), and accordingly the chemical
strip comprised in the specific apparatus should be suitable for
the parameter measured. The packed form of PFTA 100 and variation
thereof may be available to a user as OTC merchandise in a pharmacy
or supermarket according to local regulation, or sold via other
means, such as over the internet, or as an add-on to health
products, such a diet meals plans.
[0045] FIG. 2 is an upper front view illustration of PFTA 100 of
FIG. 1 in a detached position. In this figure first subunit 102 and
second subunit 104 are detached from each other, ready to be used.
In such position, in addition to the components viewed in FIG. 1,
connecting plug 130 is exposed.
[0046] FIG. 3 is a schematic "bomb view" illustration of subunit
102 of PFTA 100 of FIG. 1 showing all the components comprised in
subunit 102 in accordance with one variation of the invention.
Shown in this view are: housing 122 (upper and lower parts), slot
140 within transparent cover 124, chemical strip 150, adaptor 180
comprising connecting plug 130 and electric circuit 110. As shown
in this figure connecting plug 130 is adapted to be inserted into
an audio jack port of a smart phone (such as an iphone, or android)
device and comprises three rings (left, right and microphone).
Detailed description of adaptor 180 including plug 130 and audio
jack pins 510 will be described in details with reference to FIGS.
5-6 hereinafter.
[0047] FIG. 4 is a schematic illustration of one another variation
of physiological fluid testing apparatus in accordance with the
present invention that is functionally adapted to perform blood
tests. FIG. 4A is an upper front view illustration of PFTA 400 in a
packed form made of two subunits; FIG. 4B is an upper front view of
first subunit 402 of PFTA 400; FIG. 4C is an upper front view of
second subunit 404 of PFTA 400.
In more details, FIG. 4A illustrates one another variation of PFTA
in accordance with the present invention in a packed form.
[0048] FIG. 4B is a schematic illustration of subunit 402 of PFTA
400. This subunit, is physically attached via connecting plug 430
of adaptor 180 to a smart phone device at least for receiving its
power source and display means, and serves for the collection of a
drop of blood, through slot 440, into a dedicated strip 450 (for
example glucose or cholesterol strip), covered with a transparent
cover 424, where it is connected to specially designed electric
circuit (not shown) hidden in the subunit's housing 422, where the
electrochemical analysis of parameter level in a fluid sample (for
example blood glucose level, or cholesterol level) is processed and
transmitted to the smart phone. In accordance with one another
variation of the invention, PFTA 400 comprises a basic electric
circuit that only allows transmitting/delivering the signals
measured by the electric circuit of the chemical strip 150 to the
smart phone for processing and analysis. The two different
operating modes and optional measurement circuits for each of them
is described in details with reference to FIGS. 5-13. Transmission
to the smart phone (or to other computerized device such as iPad or
iPod), may be carried out either by connecting plug 430 (Earphone
or USB plug), or wirelessly, for further data collection,
displaying, storage in memory, communication, and further usage.
The electrical circuit hidden in housing 422 may send to the smart
phone digital or analog signals, where these signals will be
translated (if necessary) to digital information, that will be
displayed on the smart phone screen as fluid chemical's
concentration value (for example blood glucose level, hemoglobin
level, PSA level, cholesterol level, etc.).
[0049] The transparency character of cover 424 allows the user to
visualize the absorbance, by capillary forces, of an adequate
amount of blood sample by the electrochemical glucose strip 450.
The ability to visualize the absorbance of the sample by strip 450
is convenient for the user and allows him/her monitoring that a
proper amount of blood sample has reached the proper location to
thereby perform the required test adequately.
[0050] In a packed form (FIG. 4A), plug 430 may serve also for
establishing a physical connection with subunit 404 (FIG. 4C)
through socket 470 located in subunit 404 (FIG. 4C). The connection
between the two subunits in accordance with this variation of the
invention is mechanical attachment that is based on complementary
structure of the components involved. In the unpacked pre-operative
form, plug 430 is released from socket 470 ready to be inserted
into a smart phone via a suitable socket (headphone jack or a USB
entrance). The physical and functional connection between subunit
402 and a smart phone, through connecting plug 430, is a
"Symbiotronic" connection, meaning, that the physical connection of
the two electronic platforms, the smart phone and subunit 402,
produces a new device such as a Glucometer. While the smart phone
brings power source, display means, control buttons (either virtual
or non virtual), memory for storage, and communication abilities
(either by cellular connection or by web connection) and adequate
operation software, while subunit 402 brings the ability to collect
fluid sample and the production of a processed electrical signal,
which is understood by a said specific application software pre
installed on the smart phone, allowing the processing and display
of a specific chemical's concentration value that is being tested
in a physiologic fluid sample. The reliance on the smart phone for
power supply, processing, communication, storage, and display,
enables potentially significant simplification of the glucose
meter, a fully disposability of the apparatus, and a meaningful
reduction of its costs.
[0051] The physical connection is preferably to an analog outlet of
the smart phone but it may also be established to a digital outlet.
In such a scenario, a digital to analog converter is required as
part of the electrical circuit comprised in housing 422. The
transmission of data from subunit 402 to the smart phone may also
be conducted via connecting plug 430. Additionally or alternatively
transmission of data may be conducted via other physical connection
between subunit 402 and the smart phone or it may be conducted in a
wireless manner by any wireless connection known in the art
including without limitation Bluetooth, Radio Frequency (RF), Infra
Red (IR), sound, and RFID. In such a scenario, subunit 402 will
include the proper transmission components according to the
transmission method selected. In a scenario that PFTA 400 comprises
a specific electrical circuit with a micro processing unit that
delivers the smart phone a processed signal correlative to a
measured value in the fluid sample, only upon receipt of the
processed signals the smart phone is capable of translating the
data obtained, displaying it on a screen, keeping it in the smart
phone's memory, compare it to former results, alert the user when
the results are out of normal range, connect to an emergency center
or to a family member when a life threatening situation is
recognized (such as Hypoglycemia), or any other predetermined
operation it is designed to perform. Thus, the combination of each
variation of PFTA of the present invention and a smart phone
provides a novel platform that is adapted to serve as a mobile,
easy to use, fast operating, inexpensive, disposable, and ready to
be used any time and anywhere (24/7) laboratory, capable of
performing various physiological fluids specific tests. In the
specific embodiment illustrated in FIG. 4, the combination of PFTA
400 with a smart phone may function as a user-friendly Glucometer
capable of measuring glucose levels in the blood of any person,
either a diabetic or non diabetic (e.g. for high risk for diabetes)
person, in an inexpensive, easy to perform manner, releasing a
person from the trouble of purchasing and carrying along a specific
kit or the need for a special expensive time consuming visit to a
medical doctor to be referred for a laboratory test.
[0052] FIG. 4C is a schematic illustration of subunit 404 of device
400 in an unpacked form, ready to be used. Subunit 404 in
[0053] its unpacked form, in the case of a blood test, serves as a
personal, disposable, unit for the test lancing device to prick
one's skin (finger, arm, palm) allowing for the drawing of a tiny
drop of blood to be tested by subunit 402 while connected
symbiotronically to a smart phone. Subunit 404 comprises a housing
420, a complementary socket 470 that is functionally adapted to
hook plug 430 in the packed form (FIG. 4A), a lancet opening 460,
where it is attached to the skin of a person for pricking the skin,
a releasing button (not shown) for firing the lancet, and another
button (not shown) to cock the lancet device in the case that more
attempts are needed.
[0054] In its packed form, subunit 404, which is firmly but
reversibly, attached to subunit 402, serves as a cover for subunit
402, for protecting the test strip 450 from moisture, dust and any
possible damage of any kind, and covering connecting plug 430 for
the same purposes.
[0055] In the case of Urine, Amniotic fluid or Saliva tests,
subunit 404 serves merely as a cover, for protection purposes, as
mentioned above.
[0056] A user, intending to perform blood glucose test, separates
the two subunits 402 and 404 thereof. Then, a user should attach
subunit 402 to his smart phone that was pre-installed with specific
application software as mentioned above. In accordance with one
variation of the invention, while connecting the two pieces
together the glucometer application pops up showing that the system
is ready for glucose test. Next, a user uses subunit 404 to prick
the skin for blood drawing and attaches the drop of blood to slot
440 of subunit 402 allowing for blood to be suctioned by capillary
force into the test strip. After few seconds, test result appears
on the smart phone screen. The glucometer application software
installed of the smart phone allows the test results to be stored
in the smart phone memory and allows displaying trends and history
of previous glucose tests, for the evaluation of disease management
and data transfer.
[0057] Reference is now made to FIGS. 5A-C that schematically
illustrates an optional operation mode of PFTA 100 illustrated in
FIG. 1 in accordance with variations of the present invention, and
two optional electric circuits that may be used in such operation
mode, wherein the apparatus in this example is adapted to measure
glucose level in the blood. Shown in FIG. 5A: measurement unit 500,
i.e. a smart phone that includes an audio jack port 590 for a
microphone input M, and L and R speaker outputs, all denoted
hereinafter as audio pins 510; Adapter 180 may comprise connecting
means (not shown) to functionally connect glucose strip 150 to a
PCB comprising an electric circuit 110; and a connecting plug 130
adapted to be attached to the PCB on one end and to be inserted
into a headset jack of a smart phone on the other end to
functionally deliver to the smart phone the produced signal or a
correlated signal, either processed or non processed signal
(according to the electric circuit in use) to thereby obtain and
display a measurement of the physiological fluid parameter on the
smart phone screen. Connecting plug 130 should match the smart
phone's port. The electric circuit 110 may be a minimal electric
circuit that may include several resistors, capacitors, diodes and
inductors. Alternatively, it may comprise a MCU and additional
electric components.
[0058] Test strip 150, which may be a commercial glucose strip, is
being inserted to the appropriate header in this unit; also shown
in this figure is blood sample 190.
[0059] Generally, Smart phone 500 generates a sinus wave either in
a single frequency mode or a sweep mode, and outputs this sinus
wave through an electric circuit 180 to the strip. Going through
the blood sample, the waveform is modulated by the electrical
properties of the blood and is being reread at the microphone
input.
[0060] FIG. 5B illustrates an optional measurement electrical
circuit (13) connected to the speaker output (14) and to the
microphone input (12). Circuits (14) and (12) are general knowledge
and make the fundamental (may appear with minor changes between
several commercial products) circuit for a speaker output and
microphone input. The speaker output is generally isolated by a
series capacitor with a few uF of value.
[0061] Microphone input is composed of two main branches--ac input
and dc output. In order to operate correctly, most of the
microphones require a DC voltage that is generated by a DC power
supply (6) at the microphone input. This DC voltage (6) is passed
through a series resistor (5) generally 2.2 KOhm. In order for the
internal A/D sampler not to be saturated by this DC voltage, the
actual microphone input is isolated by a series capacitor (4) up to
the trans-conductance amplifier's input impedance (3).
[0062] A glucose strip includes a chemical enzyme that reacts
chemically with the glucose located in the blood. The chemical
reaction generates current that flows in. This current passes
through resistors (8) and (9) and is converted to a voltage
drop.
[0063] Diode (11) is used as a toggle switch that in the above
circuit is normally closed. That means that the microphone's
internal DC voltage source (6) is forward biasing the diode while
the current source is off (no measurement is taken). In such a
scenario, the speaker output sinus wave is recorded by the
microphone with minimal attenuation by the diode. When a glucose
strip is inserted and blood is to be measured, the current
generates a rise in the diode's cathode voltage and causes it to be
higher than the anode voltage. This causes the diode to serve as an
open circuit. When this occurs, the microphone records only noise,
until the strip's current is low again and the diode returns to
conduct. The time duration in which the sinus wave was shut down
and no signal was recorded, is relative to the strip's glucose
level. As the glucose level is higher, the time the diode is off is
longer.
[0064] FIG. 5C illustrates alternative electrical circuit in
accordance with variations of the present invention in which,
recording time is shortened related to the measurement circuit of
FIG. 5B. The measurement circuit illustrated in FIG. 5C generally
functions in the same manner as the former circuit, except series
capacitor (15) and parallel resistor (15). The parallel resistor
(15) is used to convert the strip's current source into a voltage
source. Additionally, capacitor (15), together with resistors (8)
and (9) functions as a differentiator. This differentiator is
functionally used to sense when the voltage generated by the
current source reaches its peak. When this happens, a negative
voltage is generated on resistor (9) and the diode returns to
conduct. This operation shortens extensively the measurement period
of time, thus enables a faster display of the measured parameter
level.
[0065] Reference is now made to FIG. 6 that schematically
illustrates one another measurement circuit in accordance with
variation of the invention for measuring glucose level in a blood
sample.
[0066] Smart phone's header connector usually comprises a
microphone (mic) input and a Left and Right speaker outputs, all
together denoted as "audio pins" 510. The mic input pin may be
connected to a sensing circuit 660 that usually includes a parallel
resistor and a series capacitor. Sensing circuit 660 is required to
thereby allow the smart phone to "sense" whether an external mic
circuit is connected. In accordance with one feature of the present
invention, the mic input is fed by the physiological fluid
parameter measured, e.g. with a glucose measurement unit Tx output
obtained from glucose measurement circuit 680.
[0067] In order to allow the smart phone device to read the
measurement obtained from the measurement module, a Tx pin is used
as a platform for a frequency modulated signal. Once the
measurement device is on, it generates an FSK signal (two distinct
frequencies symbolize `0` and `1`), and through this signal,
information regarding the status of the apparatus is transferred to
the smart phone by transferring predetermined binary "words',
wherein each "word" represents a specific status. Additionally, the
measurement module 680 may comprise a Micro processing Unit (MCU)
that functionally allows the apparatus of the present invention to
receive commands from the smart phone via the output pin (which in
fact is a speaker output pin).
[0068] In order to operate correctly, the measurement module 680
requires a DC voltage. It receives its power via an AC/DC converter
circuit 670, which include a transformer and a rectifier circuit.
The smart phone generates a low voltage, high frequency sinus wave
that is uploaded to higher voltages via the transformer. The high
voltage sinus wave is rectified by a series capacitor and a diode.
The output of this circuit is a steady DC voltage.
[0069] In more details, glucose measurement module 680 is
functionally connected to test strip 650, and may be implemented by
using MCU or analog circuit that converts currents/voltages to
readable data. Such unit is able to communicate with the smart
phone device, for example by FSK (Frequency Shift Keying)
modulation commands. Smart phone device may additionally transmit
FSK commands via one of its speaker outputs to glucose measurement
circuit 680 via Rx input and the measured data and the apparatus
status may be retransmitted to the smart phone via Tx output of FSK
waveform. The FSK received signals are then analyzed by the smart
phone and converted to real glucose measurements.
[0070] In addition to the glucose measurement circuit described in
the above, microphone (Mic) sensing circuit 610 is illustrated.
This circuit functionally allows the smart phone device to sense
when an external loading circuit is communicating with it via its
microphone input and speaker outputs. Without this circuit, the
smart phone device is not capable of recording data from the audio
jack port.
[0071] Voltage rectifier circuit 670 receives from the speakers or
earplugs output of the smart phone device sinus waves at specific
and constant frequency. These sinus waves serve as an energy source
that operates the electrical circuit. The sinus waves may be
extracted from a single speaker output or from both as a balanced
signal. The low voltage signals are up-converted to higher voltage
levels and rectified with voltage doublers/rectifiers circuits 670.
This rectifier circuit may contain diodes and capacitors with
appropriate values.
[0072] FIG. 7 is a graphic diagram of a chrip signal in accordance
with one operational option of PFTA 100 of the present invention. A
chrip signal is a basic waveform that the smart phone generates in
order to conduct the glucose analysis of the strip. The smart phone
outputs a chirp signal which is basically a sinus wave that is
being swept by its frequency at a pre-defined rate. This sweep can
be continuous or in a stepped regime. At each frequency point, the
smart phone reads the microphone input signal and stores it. Once
all the frequency points are measured, the smart phone processes
the data and shows the result.
[0073] The next paragraph describes another measurement technique
that is different from the one proposed previously. The above
measurement unit measures the time delay the high frequency signal
when recorded is off. For each delay there should be a distinct
glucose value. The measurement technique illustrated herein is base
on the idea that the strip's impedance (resistance of an object to
high frequency signal) varies with glucose levels. For this, the
speaker should output a sinus waveform in a single or swept
frequency, passing through the sample and being modulated by it.
The signal is than recorded by the microphone input circuit and
analyzed in the smart phone. It should be emphasized that this is a
novel measurement technique for measuring impedance in different
frequency values.
[0074] In more details, before the blood sample is placed onto the
test strip, the smart phone device sends a chirp signal through the
test strip for calibration purposes. Then, after the sample is
placed, smart phone device constantly sends chirp waves that
measure the medium transmission function (which includes
impedance). After several successive chirp measurements, the smart
phone device is post processing the data and calculates the glucose
levels of the sample. This technique for glucose measurement is
based on measuring impedance of the test strip during its chemical
reaction phase, and may be performed mutatis mutandis to other
physiological fluid parameters being evaluated. In such measuring
model, the smart phone device basically serves as an impedance
analyzer in the frequency range of its speaker's amplifiers
(100-20000 Hz).
[0075] More particularly, upon inserting subunit 102 (that
comprises test strip 150 with a blood sample), smart phone device
500 transmits through its speaker output an electrical waveform
that changes its frequency constantly. This waveform is known as a
chrip signal. Smart phone 500 sweeps the whole frequency band in
small time periods (less than 0.5 sec) and repeat the measurement
for a few seconds. This is performed in order to monitor changes in
the measurements that are solely related to the chemical reaction
of the glucose measurement enzyme. With the measured data, the
impedance of the blood sample is calculated and in a post
measurement process, it is further converted to glucose levels.
[0076] FIG. 8 is a graphic presentation of differentiator output
voltage vs. strip current of the electrical circuit of FIG. 5C that
allows a short recording time. As shown in the figure, upon
shortening of the recording time, the sinus waveform is lost for a
shorter time period similarly to waveform of the long time
recording circuit illustrated in FIG. 5B. However, though the rise
time remains almost as before, the fall time of the current is
being reduced dramatically (5 sec instead of 8 sec).
[0077] FIG. 9 is a graphic illustration of 100 Hz speaker signal
vs. glucose level of 48 mg/dL (8A); 198 mg/dL (8B); and 393 mg/dL
(8C) in accordance with variations of the invention. As shown in
the figure the glucose value is related to the time the pulse is
off. As the glucose level in the blood sample rises the time period
the pulse is off is extended.
[0078] FIG. 10 is a schematic functional block diagram of the PFTA
shown in FIG. 1, and a smart phone in accordance with variation of
the invention. It is well known in the art that in order to measure
glucose levels it is possible to measure either the peak current of
the pulse (as most gluco-meter does) or the Time Of Appearance
(TOA) of the peak. This TOA is measured as the time that the pulse
current (or voltage) is above a pre-defined threshold. As glucose
levels are higher, the TOA gets longer. Thus by measuring this TOA,
it is possible to link this parameter to the actual glucose
levels.
[0079] As illustrated in the figure, Speaker (1) generates a sinus
wave with a specific frequency and amplitude. The waveform is
passed through a normally close switch (2) in order to be recorded
by the smart phone's microphone (3). When a glucose measurement
begins, prior to the insertion of blood sample to the measurement
strip (7), the speaker's output signal is continuously recorded.
When the blood sample is loaded, circuit (6) monitors the strip's
voltage/current. When it passes a certain threshold, it toggels the
switch to OFF mode and the smart phone records only noise. In
accordance with one variation of the invention, this mode will
continue until the strip's current/voltage will drop below the
threshold. In accordance with one another variation of the
invention, this mode will continue until the strip's
current/voltage will start to drop (peak detection). It is clear to
a man skilled in the art that switch (2) may be set to a normally
opened working mode and upon crossing the threshold value circuit
(6) toggels the switch to ON mode.
[0080] Once recording the measurement is completed, software (4)
starts processing the recorded measurements and analyze the time
period where the signal was OFF/ON. This period is relative to the
glucose level. When a result is reached, its value is plotted onto
the system GUI, displayed and may be further stored in a data
base.
[0081] FIG. 11 is a graphic illustration of typical current values
generated by a glucose strip following a chemical reaction. As
illustrated in the figure, typical current values are generated by
a standard glucose strip. The current generated has an exponential
charging/de-charging nature with maximal peak and time constant
relative to the glucose level. When the glucose level is higher,
the current is also higher and the periods of charging and
de-charging are elongated respectively.
[0082] FIG. 12 is a graphic illustration of typical sinus wave
generated by a speaker of a smart phone for it to be recorded by
the smart phone's microphone. As shown in the figure, a typical
sinus wave is generated by the speaker for it to be recorded by the
smart phone's microphone. The frequency, amplitude and shape of the
waveform may be sinus wave or any other waveform. When an external
device is connected to the smart phone, additional wave is mounted
on this inner recorded wave. A graphic illustration of such
scenario is illustrated in FIGS. 13A-13C.
[0083] FIG. 13 is a graphic illustration of a strip current (top
part) and a microphone recorded waveform (bottom part) for three
actual distinct glucose values 48 mg/dL (13A), 189 mg/dL (13B), and
393 mg/dL (13C) in accordance with variations of the present
invention. It is clearly shown that when glucose level is higher,
the time period in which the microphone waveform is shut down is
getting longer (up to 15 sec).
[0084] It should be clear that the description of the embodiments
and attached Figures set forth in this specification serves only
for a better understanding of the invention, without limiting its
scope. It should also be clear that a person skilled in the art,
after reading the present specification could make adjustments or
amendments to the attached Figures and above described embodiments
that would still be covered by the present invention.
* * * * *
References