U.S. patent application number 16/513570 was filed with the patent office on 2020-01-16 for toilet based urine analysis system.
This patent application is currently assigned to BLOOM HEALTH, INC.. The applicant listed for this patent is BLOOM HEALTH, INC.. Invention is credited to Sergio ALVAREZ, Jon CARDER, Jesus GONZALEZ, Matthew MCCORD.
Application Number | 20200015791 16/513570 |
Document ID | / |
Family ID | 67620812 |
Filed Date | 2020-01-16 |
View All Diagrams
United States Patent
Application |
20200015791 |
Kind Code |
A1 |
MCCORD; Matthew ; et
al. |
January 16, 2020 |
TOILET BASED URINE ANALYSIS SYSTEM
Abstract
Urine analysis system that couples or integrates with a toilet.
Wirelessly links to a computer, such as a user's mobile device to
accept control inputs and report urine test results. Accepts user
input to initiate testing and deploys a urine collector into the
toilet bowl above the water to collect a urine sample. The
collected urine sample is dispensed onto multiple regions of a test
matrix that may perform many urine tests simultaneously. A single
test matrix may include multiple types of tests, such as
immunochromatography and colorimetric assays. An optical imaging
system detects reaction of the urine with reagents integrated into
the test matrix. Analysis of images may be performed locally or on
a remote server. The system may store an inventory of test matrices
to support daily testing for long durations, for example 6 months
or more before refilling.
Inventors: |
MCCORD; Matthew; (San Diego,
CA) ; CARDER; Jon; (San Diego, CA) ; ALVAREZ;
Sergio; (San Diego, CA) ; GONZALEZ; Jesus;
(San Diego, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BLOOM HEALTH, INC. |
San Diego |
CA |
US |
|
|
Assignee: |
BLOOM HEALTH, INC.
San Diego
CA
|
Family ID: |
67620812 |
Appl. No.: |
16/513570 |
Filed: |
July 16, 2019 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
16036621 |
Jul 16, 2018 |
10383606 |
|
|
16513570 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 10/007 20130101;
A61B 5/6891 20130101; A61B 5/207 20130101; C12Q 1/006 20130101;
G01N 33/54386 20130101; E03D 9/00 20130101; E03D 11/00 20130101;
G08C 17/02 20130101; E03D 2201/00 20130101; G01N 1/2035 20130101;
G01N 33/558 20130101; A61B 5/486 20130101; G01N 33/528 20130101;
A47K 13/24 20130101; C12Q 1/54 20130101; G01N 33/493 20130101; E03D
11/13 20130101 |
International
Class: |
A61B 10/00 20060101
A61B010/00; G01N 33/543 20060101 G01N033/543; G01N 33/52 20060101
G01N033/52; E03D 11/13 20060101 E03D011/13; A61B 5/00 20060101
A61B005/00; G01N 1/20 20060101 G01N001/20; G01N 33/493 20060101
G01N033/493 |
Claims
1. A toilet based urine analysis system comprising: a urine
collector configured to collect urine from a user, wherein said
urine collector comprises a deployed position and a retracted
position; wherein when said urine collector is in said deployed
position said urine collector is configured to collect urine and is
outside of a housing, wherein said housing is integrated with said
toilet, and wherein said retracted position is within or adjacent
to said housing; wherein in said deployed position, said urine
collector is inside a volume comprising an interior of a bowl of
said toilet and below a rim of said toilet; and, wherein in said
retracted position, said urine collector is within or adjacent to
said housing that is integrated with said toilet; and, a collector
movement mechanism configured to allow movement of said urine
collector from said retracted position to said deployed position,
and from said deployed position back to said retracted position; a
collector actuator configured to actuate said movement of said
urine collector from said retracted position to said deployed
position, and from said deployed position back to said retracted
position, one or more of an optical sensor, a pressure sensor, a
force sensor, a liquid sensor, a flow sensor and a capacitor that
detect whether said urine is flowing into said urine collector when
said urine collector is under said urine stream and positioned to
collect a volume of said urine; a controller coupled to said
collector actuator and to said one or more of an optical sensor, a
pressure sensor, a force sensor, a liquid sensor, a flow sensor and
a capacitor, wherein said controller is configured to coordinate
said collector actuator and said one or more of an optical sensor,
a pressure sensor, a force sensor, a liquid sensor, a flow sensor
and a capacitor, wherein said urine collector is configured to seek
a urine stream using a seek mode until said urine collector detects
said urine stream, such that said urine collector is further
configured to sweep across an area to collect said urine from said
urine stream during said seek; wherein said collector actuator
supports said seek mode that causes the urine collector to move
within a pre-programmed pattern and speed to seek said urine stream
until said urine collector detects said urine stream, and wherein
when said urine stream moves, said collector actuator triggers a
return to seek mode to detect a new location of said urine stream;
a test chamber configured to contain a test matrix comprising a
plurality of test regions, wherein each test region of said
plurality of test regions comprises one or more reagents configured
to react with one or more substances that may be present in said
urine, and wherein said test matrix further comprises at least one
test region from said plurality of test regions comprising a
colorimetric test, and immobilized active reagents configured to
interact with at least one analyte in said urine, such that when an
amount of said at least one analyte is present in said urine said
at least one test region is configured to change in color with an
intensity, and said change in color or said intensity of said
change in color is configured to indicate whether said at least one
analyte is present and in what quantities said at least one analyte
is present; a fluid transport system coupled to said urine
collector and to said test chamber, and configured to transport a
urine sample from said urine collector, and to dispense at least a
portion of said urine sample onto each test region of the test
matrix in said test chamber; an optical sensor system within or
proximal to said test chamber and configured to capture one or more
signals from said test matrix in said test chamber after said one
or more reagents have been exposed to said at least a portion of
said urine sample; a signal analyzer coupled to said optical sensor
system and configured to receive said one or more signals from said
test matrix; and, analyze said one or more signals from said test
matrix to determine test results; a cleaning solution container
configured to contain a cleaning solution and coupled to said fluid
transport system; and, a wireless communication interface; wherein
said controller is coupled to said fluid transport system, to said
optical sensor system, and to said wireless communication
interface, and wherein said controller is further configured to
control said fluid transport system, said optical sensor system,
and said wireless communication interface.
2. The toilet based urine analysis system of claim 1 further
comprising: a test matrix storage chamber configured to contain a
plurality of test matrices; a waste chamber configured to contain
used test matrices; and, a test matrix transport mechanism coupled
to said controller and configured to transport a test matrix of
said plurality of test matrices from said test matrix storage
chamber to said test chamber, and to transport said test matrix
from said test chamber to said waste chamber after testing.
3. The toilet based urine analysis system of claim 1 wherein said
controller is configured to activate said collector actuator to
move said urine collector to said deployed position; activate said
test matrix transport system to move said test matrix from said
test matrix storage chamber to said test chamber; activate said
fluid transport system to transport said urine sample from said
urine collector, and to dispense at least a portion of said urine
sample onto each test region of the test matrix in said test
chamber; activate said optical sensor system to capture said one or
more signals from said test matrix in said test chamber; activate
said test matrix transport system to move said test matrix in said
test chamber to said waste chamber; and, activate said fluid
transport system to transport said cleaning solution from said
cleaning solution container to said test chamber.
4. The toilet based urine analysis system of claim 1 wherein said
housing is mounted to a side of said bowl of said toilet; said
urine collector is coupled to an arm that is coupled to a hinge
coupled to said housing; and, said movement of said urine collector
from said retracted position to said deployed position, and from
said deployed position back to said retracted position comprises
rotation of said arm around said hinge.
5. The toilet based urine analysis system of claim 1 wherein each
test matrix of said plurality of test matrices further comprises a
barcode.
6. The toilet based urine analysis system of claim 5 wherein said
barcode identifies one or more of an expiration date; tests
performed by said plurality of test regions; and, test calibration
data for said plurality of test regions.
7. The toilet based urine analysis system of claim 1 further
comprising: a user control coupled to said controller and
configured to send a command to said controller to initiate
movement of said urine collector from said retracted position to
said deployed position.
8. The toilet based urine analysis system of claim 7 wherein said
user control comprises a button coupled to said controller.
9. The toilet based urine analysis system of claim 8 wherein said
button is coupled to said controller via said wireless
communication interface.
10. The toilet based urine analysis system of claim 7 wherein said
user control comprises a control on an application configured to
execute on a computer, mobile device or handheld device coupled to
said controller via said wireless communication interface.
11. The toilet based urine analysis system of claim 1 further
comprising: an application configured to execute on a mobile device
and configured to receive said test results from said signal
analyzer; and, display said test results to said user.
12. The toilet based urine analysis system of claim 1 wherein said
signal analyzer comprises a server coupled to said optical sensor
system via one or more network connections.
13. The toilet based urine analysis system of claim 1 wherein said
optical sensor system comprises one LED or a plurality of LEDs
configured to emit a corresponding wavelength of light or a
plurality of wavelengths of light.
14. The toilet based urine analysis system of claim 1 wherein said
test matrix comprises test regions for 5 or more different urine
analysis tests.
15. The toilet based urine analysis system of claim 1 wherein said
test matrix comprises test regions for 15 or more different urine
analysis tests.
16. The toilet based urine analysis system of claim 1 wherein said
test matrix comprises test regions for 30 or more different urine
analysis tests.
17. The toilet based urine analysis system of claim 1 wherein said
test matrix further comprises at least one test region comprising a
lateral flow test.
18. The toilet based urine analysis system of claim 2 wherein said
test matrix storage chamber is configured to contain at least 6
test matrices; and, said waste chamber configured to contain at
least 6 used test matrices.
19. The toilet based urine analysis system of claim 1 wherein said
urine collector is coupled with said toilet.
20. The toilet based urine analysis system of claim 1 wherein said
urine collector is integrated into said toilet.
21. The toilet based urine analysis system of claim 1 wherein said
urine collector comprises a trough.
22. The toilet based urine analysis system of claim 21 further
comprising lips or flanges extending from said trough.
23. The toilet based urine analysis system of claim 21 wherein said
trough is configured to minimize urine splashing via said lips or
flanges to capture said urine and direct said urine into said
trough.
24. The toilet based urine analysis system of claim 1 further
comprising a reel of test matrices comprising said test matrix.
25. The toilet based urine analysis system of claim 1 further
comprising a recommendation engine configured to convert
multi-point health data sets into dietary and lifestyle
recommendations.
26. The toilet based urine analysis system of claim 1 wherein said
test matrix is disposable and configured to be discarded after use.
Description
[0001] This application is a continuation of U.S. Utility patent
application Ser. No. 16/036,621, filed on 16 Jul. 2018, the
specification of which is hereby incorporated herein by
reference.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] 10011 One or more embodiments of the invention are related
to the field of biochemical analysis of a body fluid, such as a
urine or saliva sample, and are also related to mounting systems.
More particularly, but not by way of limitation, one or more
embodiments of the invention enable a urine sample collection and
analysis system that may be mounted on a urinal collection
apparatus, for example a toilet or urinal, while other embodiments
may be mounted on a countertop or in any convenient location.
Description of the Related Art
[0003] Analysis of a person's body fluid, for example urine,
currently requires the person to obtain a physician order, visit a
laboratory to provide a urine sample, wait for the laboratory's
specialized equipment and personnel to analyze the sample and then
release the results to the person. This process is slow,
inconvenient and expensive. Alternatively, a person may buy test
strips and urinate on them, however this approach is highly
unreliable due to lighting conditions, each person's color
sensitivity, print fidelity of the color chart provided with the
color strips, amount of urine used, time from urine exposure to
when test is read, etc. As a consequence, urine is not routinely
analyzed except for specific suspected or known medical conditions.
In addition, urine analysis is generally limited to a small number
of specific tests, because of the time and expense required to
perform the analyses. Another disadvantage of urine analysis in a
laboratory is that urine test results can vary significantly
throughout the day; urine lab tests may therefore not produce
reliable and repeatable measurements. Although labs sometimes do
24-hour urine tests in an attempt to compensate for within-day
variation, this imposes an additional collection burden on the
patient and is therefore not routinely performed. Moreover, it is
impractical for a patient to visit a lab on a regular basis for
urine analysis, so laboratory testing generally cannot monitor
trends over time. In-home urine testing would overcome many of
these limitations of laboratory urine testing. Although embodiments
herein are described in terms of urine, other embodiments may be
utilized for saliva.
[0004] Known systems that include urinalysis capabilities and that
mount on toilets are generally limited in the number of substances
that may be analyzed or have limits with respect to the number of
samples or sensitivity of the analysis. Other limitations include
lack of Internet or wireless functionality, associated remote
monitoring capabilities, and full automation.
[0005] It is desirable to have a urine analysis system that can
monitor a potentially large number of substances in urine on a
regular basis. Ideally this analysis would be performed in the
user's, or family's home, or in an office or other room associated
with at least one user, obviating the need for trips to a
laboratory or test orders from a physician. Attachment or
integration of a urine analysis system into a home toilet, or
toilet at any other location, in one embodiment for example would
provide maximum convenience and would allow for analysis whenever
the user urinates into the toilet, thus providing trends and
consistent monitoring of analytes of interest. For at least the
limitations described above there is a need for a toilet based
urine analysis system that may for example include toilet mountable
or toilet integrated housing or standalone housing, or for example
be detached and relocated to another location.
BRIEF SUMMARY OF THE INVENTION
[0006] One or more embodiments described in the specification are
related to a toilet based urine analysis system that may for
example include toilet mountable or toilet integrated housing or
standalone housing. One or more embodiments may include components
that are attached to, integrated into, or proximal to a toilet or
other apparatus that may be utilized to collect urine, such as a
urinal, so that a urine sample may be collected directly during
routine urination and analyzed immediately at the point of use.
Thus, toilet for the purpose of this disclosure also includes a
urinal or any other apparatus into which a user urinates. A user
may be any person or animal. One skilled in the art will recognize
that other embodiments may be constructed for testing saliva that
include components disclosed herein with respect to urine.
[0007] One or more embodiments of the urine analysis system may
include a urine collector, such as a cup, a container, a trough, or
an absorbent material such as Porex.RTM. for example, that may be
deployed into or near a toilet bowl so that a user can provide a
urine sample into the collector. The urine collector may have a
deployed position and a retracted position. In the retracted
position, the urine collector may be located within or adjacent to
a housing that may be mounted to the toilet. This housing may for
example protect the collector from toilet water during flushing and
toilet cleaning products when the toilet is being cleaned. In the
deployed position, the urine collector may be located inside the
toilet bowl, or possibly above the toilet bowl within a cylinder
that extends upwards from the top of the interior of the bowl,
i.e., so that the collector may be below, at, or above the plane
defined by the rim of the toilet. A collector movement mechanism,
such as for example a hinge, may allow the collector to move from
the retracted position to or from the deployed position. In one or
more embodiments the movement of the urine collector from the
retracted position to and from the deployed position may be
performed by a collector actuator.
[0008] One or more embodiments of the urine analysis system may
perform urine analysis tests by dispensing a portion of the urine
sample in the collector into a reaction chamber. The reaction
chamber may contain a single-use or multiple-use test media, for
example a reaction zone matrix, which may be used to perform one or
more tests. The media or matrix may for example be a sheet of
material with one or more test regions, where each test region has
specific reagents that perform specific urine conditioning and
analysis tests to detect specific substances in the urine. A new
test matrix may be provided for each urine analysis session. A bank
of unused test matrices may be stored in a test matrix storage
chamber. To perform urine tests, a test matrix transport mechanism
or reel system may take an unused test matrix from the storage
chamber and transport it or advance it to a reaction chamber. A
fluid transport system may then dispense urine from the urine
collector onto the test regions of the test media matrix. After the
test regions have been exposed to urine, a sensor system may then
capture one or more reported signals of the exposed test matrix.
For example, without limitation, the sensor system may include an
optical sensor system that captures one or more images of the
matrix or each test region or multiple test regions. One or more
embodiments may capture and analyze any type or types of signals,
including but not limited to images or optical signals. In one or
more embodiments, data may be collected at different time intervals
to track reaction of the urine with the test media as a function of
time. The signal values may then be transmitted to a processing
system that analyzes the data within the system, by the user's
handheld device or computer, or by a remote server to determine the
results of the tests. For example, without limitation, the data
analysis system may include an image analyzer that analyzes
images.
[0009] After the testing in the test chamber is complete, the test
matrix transport system may transport the used test matrix to a
waste chamber. A cleaning solution stored in a cleaning solution
container may then be flushed through parts of the system to
prepare it for subsequent tests. One or more embodiments may
contain or use multiple cleaning solutions, for example to support
a two-stage cleaning process with a first solution followed by a
second solution.
[0010] In one or more embodiments the test matrix may have one or
more multiple use reaction zones. These multiple use reaction zones
may for example contain an array of micro-reactors containing
immobilized active reagents that interact with the analytes of
interest. Once the reaction or reactions are complete, the
micro-reactors may be flushed, and the report signal or signals may
be captured with one or more sensors (such as for example an image
capture system). The micro-reactors may then be regenerated with an
appropriate solution or solutions, which may condition them for the
next test.
[0011] The urine analysis system may have a wired or wireless
communication interface, for example to receive commands or
transmit images, numeric data, raw image data, or test results.
Data may be encrypted for transmission in one or more embodiments.
Transmitted data may be anonymous, or it may have a security key or
other identifier for example to match it to the user. Thus,
embodiments may meet any medical law requirements, such as HIPAA
and for example may be used to facilitate communication of data to
a physician or other person. The urine analysis system may have a
controller that may for example coordinate the sensors, actuators,
processors, and communication interfaces of the system. For
example, the controller may perform or coordinate steps such as
activating the collector actuator to move the urine collector to
its deployed position, activating the test matrix transport system
to move a test matrix from the test matrix storage chamber to the
test chamber, activating the fluid transport system to transport a
urine sample from the urine collector and to dispense a portion of
the urine sample onto each test region of the test matrix in the
test chamber, activating the image capture system (or other sensor
system) to illuminate and capture one or more images (or other
signals) of the test matrix in the test chamber, activating the
test matrix transport system to move the test matrix from the test
chamber to the waste chamber, and activating the fluid transport
system to transport cleaning solution from the cleaning solution
container to the test chamber.
[0012] In one or more embodiments of the urine analysis system, the
urine collector may be coupled to an arm that is attached to a
hinge on or near the housing, where the housing may for example be
mounted to the side of the toilet bowl. Deployment or retraction of
the urine collector may be performed by rotating the arm around the
hinge, potentially using a collector actuator for example.
[0013] In one or more embodiments of the urine analysis system, the
test matrices may have a barcode. The barcode may encode or provide
an index into various types of information, including for example,
without limitation, manufacturing date(s), assembly date, an
expiration date, test calibration data, manufacturing
specifications, and an identification of the tests incorporated
into the test matrix.
[0014] In one or more embodiments a user may initiate a urine
analysis test by activating a user control, such as for example a
"start test" button. This button may be for example a physical
button (mounted for example on or near the toilet), or a button on
an application or "app" on the user's computer, mobile device or
handheld device. When the physical button or button on an app is
activated, a command may be sent over the wireless communications
interface to the controller of the urine analysis system,
indicating that the urine collector should be deployed. Device
activation controls may for example include any or all of a
physical button on the device, a wireless button on the wall or
toilet (like an Amazon Dash.TM. button, for example) (potentially
with multiple buttons for different users), a soft button within a
phone app, a handheld device, a biometric sensor like touch id that
may for example scan the user's fingerprint, a near field
communication tag, a physical gesture such as waving a hand or
foot, voice or sound activation, smart sensors on clothing or
shoes, controls on any personal device such as a phone, fitness
monitor, or smart watch, and automatic urine sample
identification.
[0015] One or more embodiments of the urine analysis system may
include or communicate with an app on a computer, mobile, handheld
or any other electronic device that receives test results and
displays them to the user.
[0016] The image analyzer or other signal analyzer or analyzers of
the urine analysis system may be local to the toilet mounted
components, or remote from these components. For example, in one or
more embodiments, the signal analyzer may be a server that receives
image data (or other signal data) over a network connection; the
server may then transmit results to the user's mobile device.
[0017] In one or more embodiments of the urine analysis system, the
sensor system may include multiple LEDs or other light sources,
each of which emits a specific wavelength of light or one or more
wavelengths or ranges of wavelengths of light. These different
wavelengths may be optimal for a particular test or different tests
on the test matrix.
[0018] Test matrices may contain several test regions; for example,
in one or more embodiments test matrices may contain any number of
test regions, constrained only by the number of tests that fit in
the chamber, and any number of tests per cartridge, for example 6,
20, 30, 60, 180, or more different urine analysis tests or any
other number per cartridge. Test regions may include for example
both lateral flow tests and colorimetric tests on the same test
matrix for example.
[0019] In one or more embodiments, the test matrix storage chamber
and the waste chamber may have capacity to store at least 180 test
matrices. This capacity may for example support daily use of the
urine analysis system for approximately 6 months or more.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The above and other aspects, features and advantages of the
invention will be more apparent from the following more particular
description thereof, presented in conjunction with the following
drawings wherein:
[0021] FIG. 1 illustrates an embodiment of a toilet based urine
analysis system that collects a urine sample from a user, analyzes
various substances in the urine using analytical supplies and
equipment attached to the toilet, and transmits results to a remote
computer, such as the user's mobile device.
[0022] FIG. 2 shows a block diagram of an embodiment of the
invention.
[0023] FIG. 3 shows an architectural diagram of an embodiment of
the invention that illustrates physical, electrical, and fluid
connections.
[0024] FIG. 4 shows an illustrative flowchart of steps for an
embodiment of the invention that collects and analyzes urine.
[0025] FIGS. 5A, 5B, and 5C show an illustrative urine collector,
which for example may be a collector cup in one or more
embodiments.
[0026] FIGS. 6A, 6B, 6C, and 6D illustrate deploying the urine
collection mechanism.
[0027] FIG. 6E illustrates a challenge in collecting urine that may
be dispensed by the user anywhere within a wide area within the
toilet.
[0028] FIG. 6F illustrates an embodiment with a collector that
incorporates a trough along a rotating arm. FIG. 6G shows a closeup
view of the collector of FIG. 6F, and FIG. 6H shows a cross
sectional view of the trough.
[0029] FIG. 7 shows an illustrative test matrix with various
reagents embedded in different regions to perform different urine
analysis tests.
[0030] FIG. 7A shows an illustrative embodiment of a lateral flow
test.
[0031] FIG. 7B shows an illustrative embodiment with a horizontally
oriented test matrix sandwiched between a top clamp through which
imaging occurs and a bottom clamp through which urine flows.
[0032] FIGS. 7C and 7D show the read side and exposure side,
respectively, of an illustrative test matrix that may for example
be used in conjunction with the test chamber of FIG. 7B.
[0033] FIG. 7E shows an illustrative embodiment with a vertically
oriented test matrix and a vertically oriented test chamber.
[0034] FIG. 7F shows the embodiment of FIG. 7E with urine partially
filling the test chamber.
[0035] FIG. 8 shows illustrative compartments and mechanisms for
storage, use, and disposal of test matrices.
[0036] FIG. 8A shows an illustrative embodiment that employs a reel
to reel system for test matrix storage and transport.
[0037] FIG. 9 shows spectral response curves for an illustrative
colorimetric test that may be performed by one or more embodiments
of the invention, illustrating a procedure that may be used to
select one or more wavelengths of light to illuminate the test
matrix.
[0038] FIG. 10 shows several illustrative architectures for
analysis of test matrix signals (such as images, for example) to
determine urine test results.
[0039] FIG. 11 shows an illustrative architecture for an embodiment
that incorporates a recommendation engine to provide users with
dietary and lifestyle recommendations based on their urine analysis
results.
DETAILED DESCRIPTION OF THE INVENTION
[0040] A toilet based urine analysis system will now be described.
In the following exemplary description, numerous specific details
are set forth in order to provide a more thorough understanding of
embodiments of the invention. It will be apparent, however, to an
artisan of ordinary skill that the present invention may be
practiced without incorporating all aspects of the specific details
described herein. In other instances, specific features,
quantities, or measurements well known to those of ordinary skill
in the art have not been described in detail so as not to obscure
the invention. Readers should note that although examples of the
invention are set forth herein, the claims, and the full scope of
any equivalents, are what define the metes and bounds of the
invention.
[0041] FIG. 1 shows an embodiment of a toilet based urine analysis
system 100 attached to toilet 110. In this illustrative embodiment,
the system 100 is mounted on the side of toilet 110. In one or more
embodiments the urine analysis system may be mounted or attached to
any portion or portions of a toilet or may be located in any area
or areas proximal to the toilet. In one or more embodiments the
urine analysis system or portions thereof may be integrated into
the toilet, for example by a toilet manufacturer, installer, or
designer. The toilet may be for single user use, family use,
company use, senior living facility, clinic, hospital, corporate
use, for example corporate compliance, or public use; it may be in
any location, including but not limited to a private dwelling, an
office building, a commercial building, or a public space. For
example, in one or more embodiments of the invention, the device
could also be stand alone on a countertop or a cart. Urine may be
provided manually from a container, a bedpan, or a urinary drainage
bag, which is useful in hospitals and elder care facilities, for
patients that have limited mobility, are bed ridden or otherwise
are unable to utilize other embodiments of the invention described
herein. One or more embodiments may provide a urine analysis system
for a pet or domestic animal. The urine analysis system may be
integrated or attached for example to a device that the pet or
animal may urine into or onto. In one or more embodiments the
animal urine analysis system may be standalone, and a person may
collect a urine sample from the animal, for example using a
container or tool, and then dispense this sample into the
standalone urine analysis system. The illustrative urine analysis
system 100 has a urine collector 101 that is shown in its deployed
position. The deployed position is located in a volume that
includes the interior of the bowl of toilet 110. In one or more
embodiments the collector's deployed position may be above the rim
of toilet 110, for example within a cylinder that extends upwards
from a horizontal section of the interior of the bowl at or near
the top of the rim. The collector 101 may be of any size and shape.
In one or more embodiments the collector 101 may be attached to or
integrated into the toilet seat 111. One or more embodiments of the
collector may be made from, or coated with, materials that do not
allow substances, including but not limited to minerals, proteins,
and bacteria, to easily adhere to the collector surface, such as
polytetrafluoroethylene (PTFE), liquid-infused polymers,
hydrophobic, super-hydrophobic, oleophobic or superomniphobic
materials and/or microscopic or nanotechnology materials, for
example that exhibit the Lotus effect, or use labyrinths that
contain only turbulent flow areas to keep sediment or any other
material from settling on a surface.
[0042] The embodiment shown in FIG. 1 illustrates a urine analysis
system mounted on a toilet. In one or more embodiments the toilet
may be a urinal or any other apparatus into which a user urinates.
In one or more embodiments the urine analysis system may be
attached to or integrated into a urine collection area that may for
example be a drain of a shower or bathtub or any other area into
which a user may urinate. In one or more embodiments the urine
analysis system may be standalone, and may for example be used to
receive urine and analyze urine collected by or from a user in any
location using any device or container.
[0043] In one or more embodiments of the invention, the system may
support collection and analysis of other body fluids or materials
instead of or in addition to urine. For example, one or more
embodiments may also provide a capability to collect and analyze
saliva.
[0044] Urine is collected in collector 101 and is transported into
the analytic components of system 100. These analytic components
may perform any desired urine analysis test or tests. In one or
more embodiments the system 100 may perform multiple tests,
potentially tens or hundreds of tests for example, on a single
urine sample collected by collector 101. Tests may involve any type
or types of reagents, assays, and detection technologies. Tests may
include, for example, without limitation, any one or any
combination of lateral flow tests, colorimetric tests, florescence
tests, surface plasmon resonance ("SPR") tests, immunoassays
(including but not limited to paper-based and liquid immunoassays),
homogeneous and immunochromatographic assays, optical sensors,
electrical sensors, chemical sensors, label and label-free
detection technologies, chromogenic assays, fluorophore-based
assays, binding events assays, and electrochemical assays.
[0045] Data from tests performed by system 100 may be transmitted
to one or more display systems, to databases, to messaging systems,
to medical record systems, or to other systems for further
analysis. In the illustrative example shown in FIG. 1, data from
system 100 is transmitted over a wireless connection 120, such as
for example a Wi-Fi or Bluetooth link, to a mobile device 130 used
for example by the consumer performing the urine test. Any device
or system may receive data from the system 100, over any type or
types of links or network connections. For example, in addition to
or instead of transmitting data to the user's mobile device 130,
the system 100 may send data to the user's physician, to a family
member or caregiver, to an insurance company or benefit manager, to
a case manager, to a pharmacy, or to a database containing the
user's medical record.
[0046] In one or more embodiments, data from urine analysis system
100 may also be transmitted to one or more other systems or devices
for further analysis. The results of these further analyses may
then be sent to the user's mobile device 130 or to any other
recipients or systems including those described above. In one or
more embodiments the mobile device 130 may perform all or part of
the analysis of the data from the urine analysis system.
[0047] Test results may be displayed on mobile device 130 or any
other system or device in any desired format. In the illustrative
example of FIG. 1, an app linked to the urine analysis system
displays a summary total health grade 140 (which may for example be
a letter grade, a numerical rating, a percentile, or any other
measure or measures), and indicators 141 and 142 showing which test
results are abnormal or of concern. For other test results, details
151 and 152 show the actual result values and a chart of results
over time. One or more embodiments may provide additional
information or options such as data or charts on all test results
including normal results, explanations of the tests, and
suggestions for lifestyle modifications or interventions to improve
results.
[0048] FIG. 2 shows a block diagram of an embodiment of the
invention. Urine collector 101 is located within or proximal to
toilet 110. It collects a urine sample 203. A fluid transport
system 204, which may for example comprise pumps, valves, tubes,
capillaries, microfluidics systems, or other elements, transports
all or a portion of urine sample 203 from the collector 101 to a
test chamber 210 for analysis. In one or more embodiments, the
collector itself may also act as a test chamber. In the embodiment
shown in FIG. 2, tests are performed by dispensing urine onto one
or more regions of a test matrix, where each region may have
reagents that react with the urine to perform one or more specific
tests. The system stores unused test matrices in a test matrix
storage chamber 211. A test matrix transport system 213 takes an
unused test matrix 212 from the storage chamber 211 and moves it
into test chamber 210. The fluid transport system 204 dispenses a
controlled volume 205 of urine onto the test regions of the test
matrix in the test chamber 210. In the illustrated embodiment, the
test matrices are disposable; they are discarded after use. In one
or more embodiments, the test matrices may be reusable.
[0049] The embodiment shown in FIG. 2 uses optical detection
elements, for example photosensor system 220 to measure the
reaction of the urine sample with the reagents of the test regions
of the test matrix. One or more embodiments may use any type or
types of detection technology, including but not limited to optical
detection. One or more light sources such as LEDs 221 may
illuminate the test matrix with source light 222, which may be of
specific wavelength(s) associated with particular tests. Reflected
light 223 is measured by optical sensor or sensors 224. Optical
sensors 224 may be any desired technology that responds to any type
of electromagnetic radiation. For example, without limitation,
sensor or sensors 224 may be a photosensor capable of detecting any
combination of light reflectance, absorption, or fluorescence, such
as for example a CMOS/CCD camera, a photodiode array, or a
spectrophotometer. Data from sensors 224 is transmitted to one or
more image analyzers to determine the results of the tests. A
controller 230 coordinates transmission of the data to the image
analyzer. Controller 230 may also coordinate the other sensors and
actuators of the urine analysis system, such as for example the
fluid transport system 204 and the test matrix transport system
213. In one or more embodiments an image analyzer 233b may be
located within or proximal to the urine analysis system. In one or
more embodiments an image analyzer 233a may be remote from the
urine analysis system, and the controller 230 may use a network
interface such as wireless communications interface 231 to transmit
image data 232 from sensor 224 to the image analyzer. A battery 240
may provide power to the electrical components of the system; in
one or more embodiments power may be supplied from an AC power
connection.
[0050] After testing is complete, the test matrix transport system
213 may transport the used test matrix 214 from the test chamber
210 to a waste chamber 215. A cleaning process may then be executed
to prepare the system for a subsequent test. For example, the
system may include one or more cleaning solution containers 250
that contain a cleaning solution. The fluid transport system 204
(or a separate cleaning fluid transport system) may then move a
cleaning solution 251 through the fluidics system, the test
chamber, or any other portions of the system to prepare for the
next test.
[0051] In one or more embodiments any or all of the fluid transport
system 204, the fluidics system, and the test chamber 210 may be
configured with one or more fluid paths that promote turbulent flow
of the urine through the system, thereby preventing or reducing
buildup of deposits or precipitates in the system that might for
example lead to clogging or suboptimal urine flow. Fluid paths may
for example incorporate one or more labyrinth shapes to promote
this turbulent flow. The system pump may also be controlled in a
manner to promote turbulent flow. In one or more embodiments a
cleaning solution 251 may be unnecessary when fluid paths provide
sufficient turbulence for a self-cleaning system.
[0052] FIG. 3 shows an architectural diagram of the components and
connections of an embodiment of the invention. Elements shown
include components 351, Y-valves 352, and fluidic valves 353.
Connections illustrated include electrical connections 361, urine
fluid connections 362, cleaning fluid connections 363, physical
connections 364, and air connections 365.
[0053] Collector 101 has a deployed position and a retracted
position. In the retracted position, the collector 101 is within or
adjacent to a housing 301. The housing 301 may for example protect
the collector and other components while the toilet is being
cleaned. A hinge 302 allows the collector to move between the
deployed and retracted positions. One or more embodiments may
incorporate any type or types of mechanisms, including but not
limited to a hinge, to allow movement of the collector between the
deployed and retracted positions. In one or more embodiments a
collector actuator 303 may be actuated to deploy or retract the
collector. In one or more embodiments the user may manually deploy
or retract the collector. In one or more embodiments, a collector
actuator may support a seek mode that causes the collector to move
within a pre-programmed pattern and speed to seek for a urine
stream until it finds it; this mode may be particularly useful for
example for a user standing or seating who does not wish to have to
aim the urine stream towards a static collector location or look
down to observe where the collector is located. For example,
without limitation, in seek mode the collector may sweep across the
front half of the toilet bowl (like a windshield wiper) until it
detects the urine stream. If the urine stream moves, this may
trigger a return to seek mode to find the new location (unless for
example sufficient urine has already been collected).
[0054] Urine fluid flows from the collector cup 101 to the test
chamber 210. A urine filter or conditioner 311 may be in-line in
this fluid flow to prepare the urine sample for testing. An optical
sensor 312a may detect the flow of urine in this connection line to
ensure that the sample is flowing correctly for the test. To
perform a test, a test matrix may be moved from a bank of test
matrices 212 in storage 211 by a test matrix actuation system 213a;
it may be received into test chamber 210 and placed into position
by a chamber actuation system 213b. Urine fluid may then be
deposited on the test matrix. In one or more embodiments urine
fluid may be deposited onto the test matrix incrementally as it
moves into or through the test chamber. Alternatively, in one or
more embodiments all tests in the test matrix may be exposed to
urine simultaneously. After urine has reacted with the test matrix
and the correct reaction/incubation time has elapsed, optical
capture system 220 may illuminate the test matrix with LEDs 221 or
other light sources, and capture images with cameras, photodiodes,
or other sensors 224. Sensor data may be sent to control board 230
and transmitted over wireless connections such as for example a
Bluetooth connection 231a or a Wi-Fi connection 231b. Electronics
and electrical sensors and actuators may be powered from battery
240.
[0055] After testing, the used test matrix may be moved to waste
storage 215, which contains used test matrices 214. The waste
chamber 215 and the unused test matrix storage chamber 211 may
include desiccants 331 and 322. One or more cleaning solutions may
then be flushed through the system to prepare for additional tests.
During cleaning, a blank test matrix may be moved from blanks 321
in storage 211 into the test chamber 210. The embodiment in FIG. 3
shows two cleaning solutions in storage containers 250a and 250b;
either or both of these solutions may be used to clean the system.
One or more embodiments may use any desired type and number of
cleaning solutions. An air pump 204a may be used to transmit fluids
such as urine and cleaning solutions. An optical sensor 312b may be
used to measure flow of the cleaning solutions or flow of urine out
of the system after testing.
[0056] FIG. 4 shows an illustrative process flow to perform one or
more urine tests. Some of these steps may be initiated or
coordinated for example by the controller in the urine testing
system, by a processor in a user's mobile device, or by a
combination thereof. In step 401 the system accepts user input via
a computer, such as a mobile device or remote computer or local
button for example and initiates a test. In step 402 the system
accepts a urine sample from the user, i.e., accepts urine into the
collector. In step 403 an unused test matrix is cycled from the
test matrix storage chamber into the test chamber. In step 404 a
fluid transport system, such as for example a microfluidics system,
transports urine from the collector 101 into the test chamber and
dispenses urine onto the test matrix regions containing tests. In
step 405, the optical system illuminates the test matrix and
captures images with one or more sensors to detect changes in color
or intensity from the reaction of urine with the reagents on the
test matrix. In step 406, the data captured by the imaging sensor
or sensors on color or intensity is transmitted to one or more
image analysis elements. Image analysis elements may be integrated
into the urine testing system or remote from the system. In step
407, the used test matrix is moved to the waste chamber. Then in
step 408, the fluid transport system is flushed with cleaning
solution. After cleaning, in step 409 the system is ready for a
subsequent test.
[0057] FIGS. 5A, 5B, and 5C show several views of an illustrative
urine collector that may be used in one or more embodiments. FIG.
5A shows collector 101 in the deployed position, located within or
above the toilet bowl. FIG. 5B shows a close-up view of cup 101.
Urine flows along tube 501 from the collector to the urine analysis
components. An exit hole 502 provides a drain for excess urine in
the cup. FIG. 5C shows a side section view of cup 101. Urine flows
through a narrow circuitous path from the cup into tube 501; this
path may function for example as a urine filter.
[0058] FIGS. 6A through 6D shows illustrative mechanisms that
support deployment of the urine collector from the retracted
position. A user may initiate deployment by pressing a physical
button 601, which may for example be installed on a wall in a
bathroom or on the toilet itself. The button may have a wireless
communications interface that transmits a signal to the wireless
interface 231 of the urine analysis system mounted to toilet 110.
In one or more embodiments the button 601 may be coupled to the
urine analysis system by a wired connection. Alternatively, a user
may use an app on a mobile device 130 and may for example initiate
deployment by pressing a control 602 on the app that sends a
wireless signal to the urine analysis system. One or more
embodiments may support mechanisms to initiate deployment of the
collector 101 without an explicit command from the user; for
example, the system may use image capture devices or other sensors
to recognize when a user is proximal to toilet 110 and may deploy
automatically when a user is present.
[0059] FIG. 6B shows an embodiment of the system with urine
collector 101 in the retracted position, in this embodiment
underneath housing 301. When the start deployment command is
received, an actuator rotates the arm holding collector 101 around
a hinge, deploying the collector cup. FIG. 6C shows the collector
cup partially deployed, and FIG. 6D shows the collector cup fully
deployed and ready to collect a urine sample.
[0060] A desirable feature of a toilet-based urine analysis system
is to be able to collect urine when the user uses the toilet,
without requiring the user to aim at a collector cup. FIG. 6E
illustrates a challenge in accomplishing this objective: users may
dispense urine at a wide variety of locations within the toilet.
For illustration, zone 611 is an area into which a male user
standing may typically dispense a urine stream. Zone 612 is an area
into which a female user seated may typically dispense a urine
stream. Zone 613 is an area into which a male user seated may
typically dispense a urine stream. Since zone 611 contains the
other two smaller zones 612 and 613, a collector that works to
collect urine from a stream anywhere in zone 611 will work for all
three cases. Collecting urine from anywhere within zone 611 may be
accomplished in one or more embodiments for example with a
collector made of a mesh or fabric material that unfolds to cover
the full area. The collector may for example be anchored at two or
more points on the toilet and may deploy to cover the entire zone
611. The collector may for example be constructed of a hydrophobic
anti-stick fabric, or a wire mesh. When collection is completed, in
one or more embodiments the unfolded collector may for example be
sucked back into a tube, or folded up like a fan, to get rid of
excess liquid.
[0061] One or more embodiments may alternatively or in addition
provide a collector capable of sweeping across the entire zone 611,
detecting when it is under the urine stream, and remaining
positioned in the stream long enough to collect an adequate volume
of urine. Detection of urine flowing into the collector may for
example use one or more pressure sensors, force sensors, liquid
sensors, flow sensors, capacitors, or any other mechanism to detect
the urine flow. Illustrative embodiments employing a sweeping
collector may include for example an embodiment with collector cup
at the end of a jointed collector arm, with actuators to rotate the
arm and to rotate at the elbow to sweep the collector cup across
the entire collection zone using two degrees of freedom. Another
illustrative embodiment may for example use a collector
incorporated into a rotating arm without an elbow joint, having a
single degree of freedom, with the collector formed as a trough
along the arm. An illustrative trough collector may for example
have a C-shaped cross section with a slot facing upward, similar to
a straw with a split cut into it. A potential advantage of a trough
collector is that only a single actuator may be needed to sweep the
collector across the collection zone.
[0062] FIG. 6F shows an illustrative embodiment with a trough
collector 621, which rotates around a joint 622 to sweep across the
collection zone. FIG. 6G shows a closeup view of the collector arm
621. FIG. 6H shows a cross section of the arm 621, illustrating a
roughly circular trough 623 with a section removed for collection,
and lips or flanges 624 that extend from the circular area outward
to the sides to capture urine across a wider zone and direct it
into the trough. Urine may for example vortex around the trough
instead of splashing out, and then flow inward along the arm to the
analysis system. The geometry of this illustrative trough collector
minimizes splashing due to its minimal splash surface. One or more
embodiments may have a trough collector that does not include lips
or flanges, for example with a trough geometry that has a large
trough surface to facilitate collection but has a shape or material
that reduces splashing off of this surface.
[0063] FIG. 7 shows an illustrative test matrix 212. Test matrices
may contain any number and any type or types of urine tests. For
example, the test matrix may be divided into regions, each of which
is impregnated with reagents and materials that condition the
sample and perform one or more specific test reactions. The
illustrative test matrix 212 contains 8 lateral flow
immunochromatography strips in regions 701a through 701h, and 18
colorimetric test pads in regions 702a through 702r. Lateral flow
strips 701a through 701h may each perform multiple tests; for
example, in one or more embodiments each strip may perform 2 to 4
tests per strip. An illustrative size of a test matrix may be for
example 38 mm high by 72 mm wide, by 0.9 mm deep. An illustrative
size for a lateral flow strip may be for example 5 mm high by 20 mm
wide. An illustrative size for a colorimetric test pad may be for
example 2 mm wide by 2 mm high. These sizes are illustrative; one
or more embodiments may use larger test matrices or smaller test
regions to achieve a higher density of tests per test matrix. For
example, a test matrix 76 mm high by 72 mm wide may contain at
least 16 lateral flow strips and 36 colorimetric test pads, using
the same test region dimensions as those described above; with two
tests per lateral flow strip, this test matrix may contain over 60
different tests. A test matrix may have multiple layers, including
for example a backing, one or more layers for reagents, and a top
laminate layer. Materials may be selected to absorb sufficient
urine sample volume to perform the tests, and to release the volume
to the regions with reagents to perform the desired assays. The top
laminate layer may have perforations through which urine flows when
dispensed by the fluid transport system. Different volumes may be
required for lateral flow tests and colorimetric tests. Urine may
be deposited along the test matrix as it moves into and through the
test chamber; as a result, different regions may be exposed to
urine for different period of time. Therefore, perforation sizes
may be different for different tests on the test matrix to
compensate for this variation in exposure times and for different
urine volumes needed for different tests.
[0064] Illustrative amounts of urine required for tests in one or
more embodiments of the test matrix may be for example
approximately 50 microliters for each colorimetric test and
approximately 150 microliters for each lateral flow test. The total
amount of urine sample required for a test matrix with dozens of
tests may be therefore on the order of 2 milliliters. (For example,
for 18 colorimetric tests and 8 lateral flow tests, the urine
amount required may be approximately 50.times.18+150.times.8=2100
microliter=2.1 milliliter.) This illustrates that one or more
embodiments of the system may not need to collect a large amount of
urine from the user to perform all of the tests in the test
matrix.
[0065] The test matrix may also contain one or more barcodes, such
as barcode 703, or similar identifying marks or elements. Barcode
703 may directly or indirectly indicate information about the test
matrix, such as its manufacture date, its expiration date,
calibration information, or identification of the tests
incorporated into the test matrix. This information may be
integrated into the barcode or may be accessible in a database
indexed by the barcode. In one or more embodiments, the barcode
information (or information indexed by the barcode) may also be
used by the controller of the urine analysis system to control
various test parameters, such as the amount of urine dispensed onto
the matrix, the amount of time of exposure to urine for the test,
and the wavelengths of light used to illuminate the test matrix.
Test matrix 212 may also contain one or more other regions for
calibration or quality control, such as for example humidity test
validation marker 704. These calibration or quality control regions
may be imaged and analyzed to ensure that the tests are valid or to
compensate for example for environmental factors or test matrix
degradation.
[0066] FIG. 7A shows an illustrative embodiment of a lateral flow
assay that may be incorporated for example into test matrix 212.
Liquid sample and buffer 710 are dispensed onto a sample pad 711.
An absorbent pad 717 on the opposite side of the lateral flow assay
provides a pulling force that moves liquid through the stages of
the test. First the sample liquid flows to conjugate pad 712, into
which a detection conjugate 713 is embedded. The sample and
conjugate then flow into nitrocellulose membrane 714. As the
lateral flow along membrane 714 continues, the sample and conjugate
reach the test line 715, which contains material that reacts with
the analyte being tested for. If enough analyte is present, the
test line may for example change color and the color change or
intensity of the color may indicate whether the analyte is present
and in what quantities. A benefit of one or more embodiments of the
system is that test results may be quantitative, rather than simply
binary (analyte present or not present); using the systems optical
imaging for example combined with analysis software, the intensity
of the color or other features of the test line may be analyzed to
determine the amount of analyte present. One or more embodiments
may incorporate lateral flow assays with multiple test lines that
may for example test for multiple analytes on the same assay; the
assay shown in FIG. 7A has a first test line 715 and a second test
line 715a. After reaching the test line or test lines, flow
continues to control line 716, which indicates that the sample and
conjugate solution has reached this area, thereby showing that the
test is valid.
[0067] In one or more embodiments, test matrices may incorporate
one or more tests that require a multistep chemical reaction. These
tests may be performed for example using multiplexed lateral flow
strip or vertical flow stacks. A multiplexed lateral flow strip may
for example have multiple test lines per strip. In vertical flow
stacks, sample and conjugate flow vertically and may be guided into
multiple channels in parallel and into multiple test areas in
series. Illustrative tests that may require multi-step assays
include for example vitamins B7, B9, and B12, and other targets
that cannot be measured with single step colorimetric tests.
[0068] In one or more embodiments, test matrices may be configured
with perforations on the "exposure side" of the matrix through
which urine is delivered, with optical imaging performed on the
opposite "read side" of the matrix. For example, one or more
embodiments may perform tests by clamping and sealing the test
chamber against the exposure side (the side with holes) and filling
the chamber with urine. Urine may for example flow through the
holes at a controlled rate (based for example on hole size and
pattern) and saturate the absorbent material. The sensor or sensors
may look at the read side and record signals as each assay changes
color/intensity over time after urine exposure; this approach may
increase the reliability of the test results for example compared
to taking a single reading after a countdown time. One or more
embodiments may expose the tests to urine and take multiple
readings at known time intervals as the test color/intensity
changes. Since different tests may require different amounts of
sample, flow rates may be controlled individually for each test in
the test matrix by altering the hole pattern opposite that
test.
[0069] In one or more embodiments the test chamber may be
configured for example with the optical system on top of the
chamber, with urine entering from the bottom of the chamber, and
with the test matrix oriented horizontally between the urine flow
and the optical system. FIG. 7B illustrates an embodiment with a
test chamber configured in this manner. The long axis of the test
chamber in this embodiment is horizontal. A top clamp 721 and a
bottom clamp 722 are clamped against test matrix 212, using for
example a moveable top clamp driven by an actuator. O-rings 729a on
the top clamp and 729b on the bottom clamp may provide a seal. The
read side 723 of the test matrix is facing upward and the exposure
side 724 of the test matrix is facing downward. Upper clamp 721 has
a transparent base 726, made for example out of glass or plastic,
through which image capture system 220 can obtain optical signals
from the test matrix 212. The read side 723 of the test matrix may
for example be covered with a transparent laminate backing 727.
Imaging may occur through this laminate backing structure and
through the transparent base 726. Urine may enter vertically
through a path 725 from the bottom to perform a test. Urine may
fill the test chamber 728 and flow through perforations on the
exposure side 724 to reach the tests embedded in read side 723. In
one or more embodiments the flow of urine into test chamber 725 may
be facilitated by vacuum suction to pull urine into the chamber. In
one or more embodiments a pump may push urine into test chamber 725
without requiring vacuum suction. After a test is performed, urine
may exit test chamber 728 through the same path 725 or through a
different path. The vertical orientation of the urine flow path may
for example facilitate draining of the test chamber after testing.
Another potential benefit of this orientation is that as the urine
flows into test chamber 728, all perforations on exposure side 724
are exposed to urine simultaneously.
[0070] One or more embodiments may orient the components of FIG. 7B
(or similar components) horizontally, rather than vertically as
depicted in FIG. 7B, and may orient the long axis of the test
chamber vertically, rather than horizontally as depicted in FIG.
7B. FIG. 7E shows an illustrative embodiment with a horizontally
oriented stack. In this embodiment the long axis of test chamber
728 is vertical, rather than horizontal as shown in FIG. 7B. Urine
entry and exit path 725a is at the bottom of the test chamber 728.
This embodiment also illustrates a vacuum line 725b at the top of
test chamber 728, which may provide suction to assist in filling
the test chamber. A potential benefit of this orientation is that
urine fills the test chamber from bottom to top; therefore, the
perforations on exposure side 724 are exposed to urine for
different periods of time as the water line of the urine in the
test chamber rises over time during filling. This difference in
exposure times may be useful in some situations where different
tests in test matrix 212 require different amounts of time. FIG. 7F
illustrates the embodiment of FIG. 7E with a partially filled test
chamber 728. Urine has reached and flowed through perforation 724a
in exposure side 724; hence the test or tests fed by this
perforation may have started reacting, while the other tests have
not yet started. In one or more embodiments the rate of filling of
test chamber 728 may be precisely controlled to provide precise
urine exposure times for each test. In one or more embodiments,
controlled filling of the test chamber may be further combined with
differences in the perforation sizes or patterns behind each test
to further control the exposure time and rate of urine flow for
each test.
[0071] FIGS. 7C and 7D show the read side 723 and exposure side
724, respectively, of an illustrative test matrix that may for
example be used with the test chamber of FIG. 7B in one or more
embodiments. In this illustrative test matrix, the individual
lateral flow and colorimetric tests are separated by dividers to
prevent cross contamination. The exposure side 724 has holes or
other perforations such as hole 730 through which urine flows to
reach the test pads.
[0072] In one or more embodiments, rather than exposing all test
pads to urine directly via the exposure side of a test matrix, a
test matrix may for example have a single sample pad (or a limited
number of sample pads), and the matrix may include fluid paths such
as glass fibers through which urine is wicked to all of the tests,
pulled for example by absorbent pads via capillary action. In
general, the test matrix may have any number and configuration of
fluidics paths integrated into the matrix to enable delivery of
urine to tests. One or more embodiments may incorporate a lateral
flow test that has one or more colorimetric tests located in the
middle of the lateral flow strip, so that the lateral flow action
itself delivers urine to multiple tests. In one or more
embodiments, multiple fluidics paths may be integrated into the
test chamber to enable separate delivery of urine to different
tests or groups of tests, or to more precisely control the timing
of urine delivery to each test.
[0073] FIG. 8 shows the internal structure of the test matrix
storage chamber 211, the test chamber 210, and the waste chamber
215 for one or more embodiments of the invention. In this
illustrative embodiment, the test matrices are stored in a stack,
and test matrices are moved from the top of the storage stack 212
to the test chamber 210, and then to the top of the waste stack 214
in the waste chamber 215. The unused test matrix stack and the
waste stack may for example be contained in removable magazines
that are inserted into the test matrix storage chamber 211 and
waste chamber 215 respectively.
[0074] FIG. 8 illustrates test matrix actuator 213a, which may for
example be a conveyor system that takes the top unused test matrix
212 from the storage stack, moves it to test chamber 210 for
testing, and then moves the used test matrix to the top of waste
stack 214. Cleaning solution container 250 is located between the
unused test matrix stack and the used test matrix stack; tube 801
carries cleaning solution from the cleaning solution container 250
into the test chamber. Tube 802 carries urine into the test chamber
to be deposited onto the test matrix. Optical capture system 220
illuminates and images the test matrix.
[0075] One or more embodiments may alternatively store test
matrices in a circular cartridge, and may for example spool a reel
of test matrices between a storage cartridge and a waste cartridge.
FIG. 8A shows an illustrative embodiment of a system that employs a
reel to reel system for test matrix storage and transport. For
example, unused test matrices may be stored in reel 811 and spooled
through test chamber 210 for testing, then wound around reel 812
for disposal. An actuator for example may rotate reel 812 to pull
new test matrices into the chamber for testing, and out of the
chamber for disposal. A tensioning system may be used to keep the
spool in position when it is not actuated and to ensure that the
matrices spool smoothly from the storage cartridge through the test
chamber to the waste cartridge. FIG. 8A also shows an illustrative
cleaning solution container 250 and battery 240. An illustrative
reel may for example store 30 tests per cartridge, with two blanks
between each test; an illustrative size for the reel to reel
mechanism in this configuration may be for example approximately 85
mm deep by 162 mm wide. Another illustrative reel may for example
store 180 tests per cartridge, with two blanks between each test;
an illustrative size for the reel to reel mechanism in this
configuration may be for example approximately 85 mm deep by 240 mm
wide. The 30 tests per cartridge system may have for example have
two 135 mL containers for cleaning solution, using three washes per
test. The 180 tests per cartridge system may for example have a
single 950 mL container for cleaning solution, using two washes per
test. The configuration may be rotated 90 degrees in either
direction so that battery 240 is on the top or bottom in other
embodiments of the invention.
[0076] One or more embodiments may illuminate the test matrix with
selected wavelengths of light to maximize the sensitivity of one or
more urine analysis tests. Different tests may respond to different
wavelengths; therefore, one or more embodiments may provide several
different wavelengths for illumination of the test matrix. FIG. 9
illustrates an example of selecting an optimal wavelength for a
specific test. The chart shows the response of reflectance 903 to
different concentrations of potassium 901 as a function of the
wavelength 902 of illuminating light. Curve 904 shows the best
sensitivity, corresponding to a wavelength of 565 nm. Other assays
may respond better to different wavelengths; hence in one or more
embodiments the optical capture system may provide various
wavelengths for illumination. In one or more embodiments these
different wavelengths may be provided for example by different
LEDs, each emitting one of the desired wavelengths. In one or more
embodiments a diffraction grating may split a single source of
incident light into various wavelengths that may be used for test
matrix illumination. A diffraction grating may also be used to
divide reflected light into different wavelength components like a
prism. Diffracting different wavelengths at different angles onto
different regions of an optical sensor (such as for example a CMOS
sensor) creates a type of spectrophotometer.
[0077] Images of the test matrix may be analyzed to determine the
results of the urine tests embedded in the test matrix. An image or
other signals to be analyzed may be any data captured by any sensor
or sensors of the urine analysis system. Analysis of images or
other signals may be performed local to the urine analysis system,
remote from the system, or via a combination of local and remote
analysis. FIG. 10 shows several illustrative alternatives for the
organization of data analysis. One or more images 1001a or other
signal data are obtained by sensors 224. In one or more embodiments
this data may be transmitted to a local data analysis processor or
processors 233b integrated into the urine analysis system mounted
to the toilet. Results 1002a may be transmitted for example over
wireless channel 120 to mobile device 130 or other systems for
storage, display, or further analysis. A second alternative is to
analyze signal data on the mobile device 130: signals 1001b may be
transmitted over wireless channel 120 to mobile device 130 and
analyzed on processor 233a in the mobile device, and results 1002b
may be displayed on the mobile device or otherwise stored or
transmitted elsewhere. A third alternative is to analyze signal
data on a server or other systems remote from both the urine
analysis system and the user's mobile device: for example, signals
1001b may be sent to mobile device 130 and signals 1001c may then
be forwarded (for example over an Internet link) to server 233c
over network or Internet 1010; results 1002c may be sent back to
mobile device 130 for display or otherwise stored or transmitted
elsewhere. In one or more embodiments, server 233c may be multiple
servers or a network of any systems that may jointly analyze the
signal data 1001c. Combinations of these approaches may be used in
one or more embodiments, with some aspects of signal analysis
occurring locally and others remotely.
[0078] One or more embodiments may include or utilize a
recommendation engine, which may for example incorporate algorithms
that convert multi-point health data sets into dietary and
lifestyle recommendations. Recommendations may be based on combined
measurements of multiple factors over time. This approach provides
several potential benefits since the body's absorption and use of
specific vitamins or minerals may depend on the presence of other
vitamins or minerals. An example is vitamin B9 which can't be
effectively utilized without adequate levels of Vitamin B12 (as
well as Vitamin B6 and Iron). Magnesium utilization depends on
levels of Vitamin B6, Calcium, Potassium, Zinc, etc. Zinc
utilization depends on levels of Copper. Copper utilization depends
on levels of Vitamin C, Iron, and Zinc. Vitamin C utilization
depends on levels of Iron. Since embodiments of the system may
measure many of the body's important vitamins and minerals (along
with hydration, amino acids, hormone levels, and other health
metrics) on a daily basis, a new layer of data may be created as
users implement dietary recommendations and see the results in real
time. Providing continuously updated recommendations and daily
monitoring of results offers significantly more potential than the
current approach in the art of obtaining yearly test results at an
annual checkup and rechecking results months later after
recommended changes have been implemented. Results may be
personalized to each unique individual based on sex, height,
weight, and other factors. Actionable recommendations may be
rapidly tested and validated or adjusted by a machine learning or
artificial intelligence process coupled to the recommendation
engine. The recommendation engine may be programmed with medical
and nutritional input from health advisors and a machine learning
system may be incorporated to update the recommendation engine as
more data is collected. Recommendations may be displayed as results
1002b on electronic device 130 for example, or on any other
computer, such as a physician's computer, such as server 233c or
any other computer connected to Internet 1010, for example in
conjunction with appropriate levels of security for sensitive
health information.
[0079] FIG. 11 shows an illustrative architecture for an embodiment
that includes a recommendation engine. Urine analysis system 100
collects data over time, which may be stored for example in a user
history 1101. This history tracks multiple results over time. Based
on the user's results and trends, a recommendation engine 1102
analyzes the data and transmits recommendations to a user device
such as mobile device 130. Transmitted recommendations may for
example also include links or other mechanisms to allow users to
purchase or order vitamins, drugs, nutraceuticals, food,
supplements, or other products. Recommendations may also be based
on a user profile 1107, which may for example include the user's
gender, age, weight, medical conditions, or other relevant
information. The recommendation engine 1102 may for example access
a knowledge base 1103 to develop the recommendations for the user.
Knowledge base 1103 may incorporate data from medical and
nutritional advisors 1104, such as scientifically supported
algorithms that determine effective recommendations or
interventions. In one or more embodiments knowledge base 1103 may
also be constructed or updated based on a machine learning system
1105, such as a deep learning network or any other learning system.
A machine learning system 1105 may for example analyze data 1106
that includes measurements, recommendations, and outcomes across
multiple users, and may update knowledge base 1103 by learning
which recommendations and interventions may improve outcomes.
[0080] While the invention herein disclosed has been described by
means of specific embodiments and applications thereof, numerous
modifications and variations could be made thereto by those skilled
in the art without departing from the scope of the invention set
forth in the claims.
* * * * *