WO 2009094761 20090806

TITLE: APPARATUS AND METHOD FOR URINALYSIS

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Pub. No.: WO/2009/094761 International Application No.:
PCT/CA2009/000089
Publication Date: 06.08.2009 International Filing Date: 23.01.20
09
IPC: G01F 1/10 (2006.01), G01F 1/06 (2006.01), G01N 1/20 (2006.01), G01N 21/7
5 (2006.01), G01N 33/48 (2006.01), G01N 35/00 (2006.01), G01T 1/167 (2006.01), G
01T 1/20 (2006.01)
Applicants: EXCELTION MEDICAL INNOVATIONS INC. [CA/CA]; Suite 14 205 Torbay
Road Markham , Ontario L3R 3W4 (CA) (All Except US).
KIANI, Farsad [CA/CA]; (CA) (US Only).
DEKKER, Edward William [CA/CA]; (CA) (US Only).
SHERMAN, Felix [CA/CA]; (CA) (US Only).
SONG, Fayi [CN/CA]; (CA) (US Only).
KISENKO, Eduard Yuriyouy [CA/CA]; (CA) (US Only).
KOIKAS, Elias [CA/CA]; (CA) (US Only).
BRIKIS, Saulius Peter [CA/CA]; (CA) (US Only).
XIONG, Hui [CN/CA]; (CA) (US Only).
Inventors: KIANI, Farsad; (CA).
DEKKER, Edward William; (CA).
SHERMAN, Felix; (CA).
SONG, Fayi; (CA).
KISENKO, Eduard Yuriyouy; (CA).
KOIKAS, Elias; (CA).
BRIKIS, Saulius Peter; (CA).
XIONG, Hui; (CA).
Agent: BERESKIN & PARR LLP; 40th floor Box 401 Toronto , Ontario M5H 3Y2 (CA) .
Priority Data:
61/025,131 31.01.2008 US
WO 2009094761 20090806
TITLE: APPARATUS AND METHOD FOR URINALYSIS

(12) International Application Status Report

Received at International Bureau: 25 March 2009 (25.03.2009)
Information valid as of: 16 July 2009 (16.07.2009)
Report generated on: 01.04.2010
(10) Publication number: (43) Publication date: (26) Publication languag
e:
WO 2009/094761 06 August 2009 (06.08.2009) English (EN)
(21) Application number: (22) Filing date: (25) Filing language:
PCT/CA2009/000089 23 January 2009 (23.01.2009) English (EN)
(31) Priority number(s): (32) Priority date(s): (33) Priority status:
61/025,131 (US) 31 January 2008 (31.01.2008) Priority document received (in
compliance with PCT Rule 17.1)
(51) International Patent Classification:
G01F 1/10 (2006.01); G01F 1/06 (2006.01); G01N 1/20 (2006.01); G01N 21/75 (2006.
01); G01N 33/48 (2006.01); G01N 35/00 (2006.01); G01T 1/167 (2006.01); G01T 1/20
(2006.01)
(71) Applicant(s):
EXCELTION MEDICAL INNOVATIONS INC. [CA/CA]; Suite 14 205 Torbay Road Markham , O
ntario L3R 3W4 (CA) (for all designated states except US)
KIANI, Farsad [CA/CA]; 15 Sabrina Court Richmond Hill , Ontario L4C 5P8 (CA) (fo
r US only)
DEKKER, Edward William [CA/CA]; 14 Vonda Avenue North York , Ontario M2N 5E7 (CA
) (for US only)
SHERMAN, Felix [CA/CA]; 61 Forest Run Blvd. Concord , Ontario L4K 5J6 (CA) (for
US only)
SONG, Fayi [CN/CA]; 1 Beethoven Court North York , Ontario M2H 1W1 (CA) (for US
only)
KISENKO, Eduard Yuriyouy [CA/CA]; 64 Raintree Crescent Richmond Hill , Ontario L
4E 3T6 (CA) (for US only)
KOIKAS, Elias [CA/CA]; 71 Gaiety Drive Scarborough , Ontario M1H 1B9 (CA) (for U
S only)
BRIKIS, Saulius Peter [CA/CA]; 83 Mill Road Etobicoke , Ontario M9C 1X6 (CA) (fo
r US only)
XIONG, Hui [CN/CA]; 1 Beethoven Court North York , Ontario M2H 1W1 (CA) (for US
only)
(72) Inventor(s):
KIANI, Farsad; 15 Sabrina Court Richmond Hill , Ontario L4C 5P8 (CA)
DEKKER, Edward William; 14 Vonda Avenue North York , Ontario M2N 5E7 (CA)
SHERMAN, Felix; 61 Forest Run Blvd. Concord , Ontario L4K 5J6 (CA)
SONG, Fayi; 1 Beethoven Court North York , Ontario M2H 1W1 (CA)
KISENKO, Eduard Yuriyouy; 64 Raintree Crescent Richmond Hill , Ontario L4E 3T6 (
CA)
KOIKAS, Elias; 71 Gaiety Drive Scarborough , Ontario M1H 1B9 (CA)
BRIKIS, Saulius Peter; 83 Mill Road Etobicoke , Ontario M9C 1X6 (CA)
XIONG, Hui; 1 Beethoven Court North York , Ontario M2H 1W1 (CA)
(74) Agent(s):
BERESKIN & PARR LLP; 40th floor Box 401 Toronto , Ontario M5H 3Y2 (CA)
(54) Title (EN): APPARATUS AND METHOD FOR URINALYSIS
(54) Title (FR): APPAREIL ET PROCÉDÉ D'ANALYSE D'URINE
(57) Abstract:
(EN): A urinalysis apparatus operates in an automated fashion to determine at le
ast one user characteristic from at least one measured parameter of a urine samp
le that is provided directly by a user. The urinalysis apparatus includes an inl
et for receiving the urine sample and at least one sensor unit having at least o
ne sensor configured to measure at least one parameter from at least a portion o
f the urine sample. The urinalysis aparatus also has a urine transport assembly
for transporting the urine sample from the inlet to a sensor unit during a measu
rement mode, and a cleansing fluid transport assembly for disposing of the urine
sample after the measurement mode and cleansing the apparatus during a cleanse
mode. The urinalysis apparatus can also include other sensor units and a flow me
ter unit.
(FR): L'invention porte sur un appareil d'analyse d'urine qui fonctionne en mode
automatisé et permet de mesurer au moins une caractéristique utilisateur à part
ir d'au moins un paramètre mesuré d'un échantillon d'urine directement fourni pa
r l'utilisateur. L'appareil d'analyse d'urine selon l'invention comprend une ent
rée destinée à recevoir l'échantillon d'urine et au moins une unité capteur comp
renant au moins un capteur configuré pour mesurer au moins un paramètre à partir
d'au moins une partie de l'échantillon d'urine. L'appareil d'analyse d'urine pr
écité comprend aussi un ensemble de transport d'urine destiné à transporter l'éc
hantillon d'urine depuis l'entrée jusqu'à une unité capteur dans un mode de mesu
re, et un ensemble de transport de liquide de nettoyage destiné à évacuer l'écha
ntillon d'urine après le mode de mesure et à nettoyer l'appareil dans un mode de
nettoyage. L'appareil d'analyse d'urine peut également comprendre d'autres unit
és capteurs et une unité débitmètre.
International search report:
Received at International Bureau: 17 April 2009 (17.04.2009) [CA]
International preliminary examination report:
Not available
(81) Designated States:
AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CN, CO,
CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN,
HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT,
LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH,
PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT,
TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
European Patent Office (EPO) : AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, G
B, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, S
K, TR
African Intellectual Property Organization (OAPI) : BF, BJ, CF, CG, CI, CM, GA,
GN, GQ, GW, ML, MR, NE, SN, TD, TG
African Regional Intellectual Property Organization (ARIPO) : BW, GH, GM, KE, LS
, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW
Eurasian Patent Organization (EAPO) : AM, AZ, BY, KG, KZ, MD, RU, TJ, TM

FIELD
The embodiments described herein relate to an apparatus and method for urinalysi
s.
BACKGROUND
Urinalysis, which is the analysis of a urine sample, is a common medical test th
at can reveal important health related information about the person or animal th
at provided the urine sample. A urine sample can be analyzed to determine whethe
r a person is leading a healthy lifestyle by determining what vitamins and miner
als are not being assimilated into the body. A urine sample can also be analyzed
to determine whether a person has consumed illegal or banned substances. A urin
e sample can also be analyzed to detect the presence of biomolecules that indica
te whether a person has developed cancer, or has any of a number of infectious d
iseases. A urine sample is also commonly analyzed to determine whether a woman i
s pregnant.
A person whose urine is to be analyzed typically provides one or more urine samp
les to a physician or other medical professional. The urine samples are sent, so
metimes through a courier service, to a medical laboratory for analysis. Trained
medical laboratory technologists or physicians at the medical laboratory then c
onduct the necessary tests on the urine samples, and subsequently send the resul
ts back to the physician. Tests in a medical laboratory are often conducted in b
atches, with several urine samples from different people being analyzed together
.
A number of problems arise with this process. First, the costs of operating medi
cal laboratories are generally borne by the health care system (public or privat
e). As a result, urinalysis tests may not be as accessible by people who would l
ike to get tested to determine the state of their health without having to visit
a physician. Second, the time delays involved may inconvenience both physicians
as well as the people whose urine is being analyzed. In some
instances, the time delays can lead to undesirable consequences resulting from d
elayed diagnosis of a disease. Third, there is potential for urine samples to be
mixed up, misplaced, or tampered with, either at the laboratory or during deliv
ery, thereby reducing the accuracy and reliability of the analysis.
SUMMARY
In a first aspect of the invention, at least one exemplary embodiment described
herein provides a urinalysis apparatus comprising a housing; an inlet disposed a
long a portion of the housing and configured to receive a urine sample from a us
er; at least one sensor unit disposed within the housing and having at least one
sensor configured to measure at least one parameter from at least a portion of
the urine sample; a urine transport assembly disposed within the housing and con
figured to transport the urine sample from the inlet to the at least one sensor
unit during a measurement mode; a cleansing fluid transport assembly disposed wi
th the housing and configured to dispose of the urine sample after the measureme
nt mode and cleanse the apparatus during a cleanse mode; and a control module co
nfigured to control the urinalysis apparatus in an automated fashion and determi
ne at least one user characteristic from the at least one measured parameter.
In another aspect of the invention, at least one exemplary embodiment described
herein provides a method for performing urinalysis. The method comprises: receiv
ing a urine sample from a user; providing at least a portion of the urine sample
via a urine transport assembly to at least one sensor unit; measuring at least
one parameter from the at least a portion of the urine sample during a measureme
nt mode; disposing the urine sample after the measurement mode;
cleansing the apparatus during a cleanse mode; and providing test results on at
least one user characteristic based on the at least one measured parameter.
In yet another aspect of the invention, at least one exemplary embodiment descri
bed herein provides a flow meter unit for measuring a flow rate of a fluid strea
m. The flow meter unit comprises an intake bucket having an inlet adapted to rec
eive the fluid stream and an outlet adapted to release the measured fluid stream
; a rotating element disposed within the intake bucket, the rotating element hav
ing a plurality of angled surfaces; an actuator configured to rotate the rotatin
g element at a nominal rotation rate; a sensor unit configured to sense the rota
tion of the rotating element; and control circuitry configured to sense deviatio
ns in the rotation of the rotating element from the nominal rotation rate in ord
er to calculate the flow rate of the fluid stream and control the actuator to ro
tate the rotating element at the nominal rotation rate, wherein, in use, deviati
ons from the nominal rotation rate are due to the fluid stream contacting the ro
tating element.
In yet another aspect of the invention, at least one exemplary embodiment descri
bed herein provides a method of measuring a flow rate of a fluid stream. The met
hod comprises: rotating a rotating element having a plurality of angled surfaces
at a nominal rotation rate; directing the fluid stream onto the angled surfaces
of the rotating element; sensing the rotation of the rotating element; and calc
ulating the flow rate of the fluid stream based on deviations in the rotation of
the rotating element from the nominal rotation rate.
In yet another aspect of the invention, at least one exemplary embodiment descri
bed herein provides an inlet module adapted to receive a urine sample
from a micturating user. The inlet module comprises a funnel configured to recei
ve the urine sample from the user during use; and an outlet port disposed along
a first portion of the funnel and configured to provide the urine sample to a do
wnstream device during use. In yet another aspect of the invention, at least one
exemplary embodiment described herein provides a radiation sensor unit configur
ed to detect radioactive components in a fluid sample. The radiation sensor unit
comprises a scintillator flow cell configured to receive the fluid sample and p
roduce a photon light signal in proportion to the radioactive components include
d in the fluid sample; a photoelectric conversion module configured to convert t
he photon light signal into a photoelectric signal and amplify the photoelectric
signal; and electrical circuitry configured to further amplify the photoelectri
c signal to produce a pre-processed electrical signal.
In yet another aspect of the invention, at least one exemplary embodiment descri
bed herein provides a method of detecting radioactive components in a fluid samp
le. The method comprises: transporting the fluid sample through a scintillation
flow cell which produces a photon light signal in proportion to the radioactive
components included in the fluid sample; converting the photon light signal into
a photoelectric signal; amplifying the photoelectric signal to produce a pre- p
rocessed electrical signal; and analyzing the pre-processed signal to determine
concentration and type of the radioactive components in the fluid sample.
In yet another aspect of the invention, at least one exemplary embodiment descri
bed herein provides a surface plasmon resonance detection unit configured to det
ect components of interest in a fluid sample. The detection unit comprises a sur
face plasmon resonance sensor; a flow cell abutting a sensing surface of the sur
face plasmon resonance sensor and adapted to
channel the fluid sample over the sensing surface in an automated fashion; and a
n imaging system coupled to the Surface Plasmon Resonance (SPR) sensor and confi
gured to measure changes on the sensing surface due to interactions with compone
nts in the channeled fluid sample. In yet another aspect of the invention, at le
ast one exemplary embodiment described herein provides a method of detecting com
ponents of interest in a fluid sample. The method comprises: channeling the flui
d sample over a sensing surface of a Surface Plasmon Resonance (SPR) sensor in a
n automated fashion; and imaging the sensing surface to measure changes on the s
ensing surface due to interactions with components in the channeled fluid sample
.
Further aspects and features of the exemplary embodiments described herein will
appear from the following description taken together with the accompanying drawi
ngs.
BRIEF DESCRIPTION OF THE DRAWINGS
For a better understanding of the various exemplary embodiments described herein
, and to show more clearly how these exemplary embodiments may be carried into e
ffect, reference will be made, by way of example, to the drawings in which:
FIG. 1 is a perspective view of an exemplary embodiment of a urinalysis apparatu
s that is portable;
FIG. 2 is a schematic diagram illustrating various components of the urinalysis
apparatus of FIG. 1 ;
FIG. 3 is a schematic diagram illustrating an exemplary embodiment of various pi
ping components of the urinalysis apparatus of FIG.
1;
FIG. 4 is a flow chart diagram illustrating an exemplary embodiment of a flow se
quencing method for the urinalysis apparatus;
FIG. 5A is a perspective view of an exemplary embodiment of an inlet of the urin
alysis apparatus of FIG. 1 ; FIG. 5B is a cross-sectional view along line B-B of
the inlet of
FIG. 5A;
FIG. 5C is an exploded perspective view of the inlet of FIG. 5A;
FIG. 6A is a schematic block diagram illustrating an exemplary embodiment of a f
low meter unit for measuring the flow rate of a fluid stream; FIG. 6B is a persp
ective view of an exemplary embodiment of the flow meter unit of FIG. 6A;
FIG. 6C is a partial cross-sectional view along line C-C of the flow meter unit
of FIG. 6B;
FIG. 6D is a schematic circuit diagram of an exemplary circuit module of the flo
w meter unit of FIG. 6A;
FIG. 7A is a perspective view of an exemplary embodiment of a housing for a sens
or unit that can be used with the urinalysis apparatus of FIG. 1 ;
FIG. 7B is a cross-sectional view along the line B-B of the sensor body of FIG.
7A;
FIG. 7C is a perspective view of the sensor body having sensors inserted into th
e sensor body;
FIG. 7D is a rear view of the sensor body of FIG. 7C;
FIG. 7E is a side perspective view of an exemplary embodiment of a sensor for th
e sensor body;
FIG. 8 is a schematic diagram of an exemplary embodiment of a Surface Plasma Res
onance (SPR) sensor unit that can be used with the urinalysis apparatus of FIG.
1 ;
FIG. 9A is a schematic block diagram of an exemplary embodiment of a scintillati
on sensor unit that can be used with the urinalysis apparatus of FIG. 1 ;
FIGS. 9B to 9E are various diagrams of an exemplary embodiment of a scintillator
flow cell that can be used in the scintillation sensor unit of FIG. 9A;
FIGS. 1OA to 10E are various illustrations of an exemplary embodiment of a scint
illation sensor unit that can be used with the urinalysis apparatus of FIG. 1 ;
and FIG. 11 is a flow chart diagram illustrating an exemplary embodiment of a me
thod for operating the urinalysis apparatus of FIG. 1.
The person skilled in the art will understand that the drawings, are for illustr
ation purposes only and that they are not intended to limit the scope of the app
licant's teachings in any way.
DETAILED DESCRIPTION
It will be appreciated that for simplicity and clarity of illustration, where co
nsidered appropriate, reference numerals may be repeated among the figures to in
dicate corresponding or analogous elements. In addition, numerous specific detai
ls are set forth in order to provide a thorough understanding of the inventive e
mbodiments described herein. However, it will be understood by those of ordinary
skill in the art that the embodiments described herein may be practiced without
these specific details. In other instances, well-known methods, procedures and
components have not been described in detail so as not to obscure the inventive
embodiments described herein. Also, the description of the various examples prov
ided herein is meant to further an understanding of various aspects of the appli
cant's teachings and should not be construed as limiting the scope of the presen
t teachings in any way. Furthermore, it should be noted that the word "exemplary
" is used herein to denote an example of an inventive embodiment,
and does not necessarily indicate a preferred implementation of the inventive em
bodiment.
Referring first to FIG. 1 , shown therein is a perspective view of an exemplary
embodiment of a urinalysis apparatus 10 that is portable. The urinalysis apparat
us 10 comprises a housing 12 in the form of a kiosk that houses various componen
ts of the urinalysis apparatus 10. The housing 12 has an inlet 14 for receiving
a urine sample from the user while the user micturates (i.e. urinates). The urin
e sample is received by the inlet 14 and provided to various components within t
he urinalysis apparatus 10 that analyze the urine sample. The front panel of the
housing 12 includes a number of components that allow the user to interact with
the urinalysis apparatus 10. The urinalysis apparatus 10 further includes a con
sole 16, also known as a user interface, formed of a display 18, a keypad 20, a
card reader 22, a biometric scanner 24 and a printer 26. The urinalysis apparatu
s 10 also includes a plurality of ventilation vents 28 and a plurality of caster
wheels 30. The placement of some of these elements can be varied in alternative
embodiments. Some of these elements are optional in some cases.
The console 16 allows the user to use the urinalysis apparatus 10 to perform a u
rine test and to receive a report of the results of the urinalysis. The display
18 provides instructions to the user on how to use the urinalysis apparatus 10.
The user can then use the keypad 20 to select various test options, i.e. select
a particular type of urinalysis test, as well as to enter identification informa
tion. The display 18 can be a cathode-ray tube display, a plasma display, an LCD
display or any other suitable display mechanism. The keypad 20 is a keyboard, a
 touchpad, or some combination thereof. In alternative embodiments, the display
18 can be a touch screen display, which also provides the keypad functionality;
in this case the keypad 20 is optional. Also, in alternative embodiments, the ke
ypad 20 can include a trackball or can be replaced by a trackball. The biometric
scanner 24, which is optional, can be used to collect biometric data that can b
e used to measure a biometric parameter of the user to identify
the user. The measured biometric parameter can be communicated by a communicatio
n module (see FIG. 2) to a remote system (not shown) to identify the user and ac
cess related personal and/or test information. The measured biometric parameter
can also be used to determine which user characteristic is to be analyzed by the
urinalysis apparatus 10. In this exemplary embodiment, the biometric scanner 24
is a fingerprint reader. However, in alternative embodiments, the biometric sca
nner 24 can be an eye scanner, a facial scanner and the like. Alternatively, the
user can use the card reader 22 along with a public or private health insurance
card, or other identification card such as a driver's license, to identify them
selves.
Once the user selects a particular type of test and has entered any required inf
ormation, the user uses a payment unit, which accepts payment from the user to c
ommence the urine test. In this embodiment, the payment unit includes the card r
eader 22 that can accept a credit card, bank debit card, or a specialized card,
to receive payment for the particular urinalysis test to be conducted by the uri
nalysis apparatus 10. In some embodiments, the payment unit also includes a mone
y deposit mechanism (not shown) that accepts coins and/or banknotes to provide t
he user with a number of ways to provide payment for using the urinalysis appara
tus 10. It should be noted that there can be alternative embodiments in which pa
yment is not required to conduct a urine test.
After the test is completed, the display 18 can provide test results and other i
nformation to the user. The printer 26 can also provide the user with the result
s of the urinalysis test in the form of a printout of information about the urin
e sample. The printer 26 can also provide any other required information, such a
s a receipt for payment received from the user for using the urinalysis apparatu
s 10 as well as further information or instructions to take further steps depend
ing on the type of test conducted and the test results. For example, for positiv
e test results of a serious condition, further information can be provided to th
e user with regard to taking appropriate medical action. The test
information can also be communicated to a remote location as explained in furthe
r detail below.
The housing 12 may be made from stainless steel panels, or other appropriate mat
erials well known to those of skill in the art. The ventilation vents 28 are dis
tributed along the upper and lower portions of the side and back panels of the h
ousing 12 to provide a heat pathway through which heat generated by the internal
components of the urinalysis apparatus 10 can be ventilated in order to keep th
e components at a safe operating temperature. In some embodiments, ventilation f
ans (not shown) are used within the housing 12 to enhance heat transfer to the e
xterior of the housing 12. The caster wheels 30 are coupled to the base of the h
ousing 12 to allow the urinalysis apparatus 10 to be easily transported. The cas
ter wheels 30 typically include a locking mechanism to prevent the urinalysis de
vice 10 from inadvertently moving while in use. Referring now to FIG. 2, shown t
herein are various components of the urinalysis apparatus 10 according to an exe
mplary embodiment. The urinalysis apparatus 10 generally includes a control modu
le 50, a flow meter unit 52, a sensor unit 54, a cleansing fluid transport assem
bly 56, a waste assembly 58, and a communications module 60. The flow meter unit
52 is optional. It should be noted that only a portion of the cleansing fluid t
ransport assembly 56 is shown in FIG. 2. A more detailed view of the cleansing f
luid transport assembly 56 is shown in FIG. 3. Also, it should be noted that the
 urinalysis apparatus 10 also includes a urine transport assembly, portions of w
hich are shown in FIG 2. The urine transport assembly is shown more clearly in F
IG. 3. The urinalysis apparatus 10 further includes a USB hub 62, an Input/Outpu
t (I/O) module 64, a power supply control panel 66, a power supply unit 68 and a
uxiliary ports 70.
The control module 50 controls the operation of the various mechanical and elect
ronic components of the urinalysis apparatus 10. The control module 50 can be im
plemented by any suitable micro-processor or controller as is commonly known by
those skilled in the art. The control module 50 also
includes memory components and the like. The memory components can be used to ma
intain information on studies that can be conducted based on all of the urine te
sts that are performed. The control module can be implemented with an off-the-sh
elf processor, such as a 3 GHz processor, with a suitable amount of RAM on the o
rder of 1 GB. The control module 50 can control various components such as the f
low meter unit 52, the urine and cleansing fluid transport mechanisms, and the s
ensor unit 54. For instance, the control module 50 controls the on and off state
of various electronic values thereby allowing or disallowing fluid flow through
various sections of the urinalysis apparatus 10. The control module 50 also con
trols various pumps to flush various fluids, such as cleansing fluids and calibr
ation fluids, for example, through certain portions of the urinalysis apparatus
10 as required.
The control module 50 also performs a number of other functions, including analy
zing the various measured parameters to determine at least one characteristic of
the user who provided the urine sample. For example, the control module 50 rece
ives uroflowmetric data from the flow meter unit 52 and sensor data from the sen
sor unit 54 based on the urine sample provided by the user and processes this da
ta to determine one or more characteristics of the user. The control module 50 c
ommunicates with the various components of the urinalysis apparatus 10 primarily
through the USB hub 62, but can also use another serial or parallel communicati
ons bus, an IEEE-488 interface bus (also known as a Hewlett Packard Interface Bu
s or HP-IB), or any other suitable communications methods known to one of skill
in the art. The USB hub 62 interfaces the control module 50 to the card reader 2
2, the biometric scanner 24, and the display 18. In this case, the display is sh
own as an LCD touch display 18' (accordingly there is no keypad 20) and there is
also a camera 74 that is interfaced to the control module 50 by the USB hub 62.
Also in this example, the biometric scanner 24 is a finger print scanner. The c
ontrol module 50 also has a direct connection to the display 18' to control disp
lay (i.e. VGA) parameters. The display 18' can be a Planar LA1500RTC
open-frame liquid crystal touch screen display. The card reader 22 can be a Magt
ek MT-215 USB card reader system and the finger print scanner 24 can be a ZVETCO
P4000-TPM finger print reader system. The camera can be a black and white CCD c
amera. The printer 26 can be a Nanoptix T1A-02 HD- Kiosk thermal printer.
The USB hub 62 also connects the control module 50 to the I/O module 64. The I/O
module 64 is an Analog-to-Digital Converter that interfaces with the flow meter
unit 52, the sensor unit 54, the urine transport assembly, the cleansing fluid
transport assembly 56, and the waste assembly 58. The I/O module 64 has multiple
input channels with high impedance inputs for receiving sensor signals from var
ious components of the urinalysis apparatus 10 and an ADC. These digitized signa
ls may then be digitally multiplexed either in series or in parallel and provide
d to the USB hub 62 which then sends the signals to the control module 50. The I
/O module 64 can be implemented with a 16-bit channels and a 10-bit ADC.
The control module 50 is also connected to the communications module 60 to commu
nicate with a remote server (not shown) over a communications link. The communic
ations link can be a secure link. The communications module 60 is a cable modem
that can establish the secure communications link over a cable line based commun
ications network. In alternative embodiments, the communications module 60 can b
e a digital subscriber line modem that can establish the secure communications l
ink over the lines of a telephone network. Alternatively, the communications mod
ule 60 can be a wireless transceiver that can establish a secure communications
link over a wireless network such as an 802.11 wireless local area network, a ce
llular network such as a Global System for Mobile Communications (GSM), a Code D
ivision Multiple Access (CDMA) network, or a 3G network. The secure communicatio
ns link can be established using a transport layer security protocol (TLS) or a
secure sockets layer protocol (SSL). Other communications technologies can be us
ed, which will be apparent to one of skill in the art.
The control module 50 is also connected to auxiliary ports 70 to receive inputs.
For example, a technician can connect a keyboard or mouse to one of the auxilia
ry ports 70 to interact with the control module 50 and perform various operation
s such as calibration or maintenance. The inlet 14 receives a urine sample from
a user. A portion of the urine transport assembly provides the urine sample from
the inlet 14 to the flow meter unit 52 primarily under the influence of gravity
, rather than under the influence of a pump. The flow meter unit 52 measures the
flow characteristics of the urine sample. Accordingly, providing the urine samp
le primarily under the influence of gravity, and without any blockages, allows t
he flow meter unit 52 to accurately sense the flow characteristics of the urine
sample. The controller 52c is the electronic portion of the flow meter unit 52 a
nd consists of an actuator/transducer and associated electronics that detect cha
nges in the flow rate of the urine sample when it is being provided by the user.
The output of the flow meter unit 52 is sent to an input channel of the I/O mod
ule 64. The flow meter unit 52 is described in further detail with respect to FI
GS. 6A-6D.
The flow rate measured by the flow meter unit 52 allows the control module 50 to
determine when a urine sample has been provided, and the volume of the urine sa
mple. The volume of the urine sample is determined because a certain minimum amo
unt of urine is required in order to properly perform urinalysis. For example, t
he sensor unit 54 requires a certain amount of urine to be able to properly sens
e certain components of the urine sample. This minimum amount of urine may be on
the order of 50 ml but this depends on the configuration and the number of the
sensor units. Various uroflowmetric parameters can be measured and analyzed. For
instance, with information measured by the flow meter unit 52, the urinalysis a
pparatus 10 can construct a flow profile which graphs flow rate versus elapsed t
ime. Various parameters can be obtained from this profile such as peak flow rate
, maximum increase in flow rate, flow duration and the like. In addition, the be
ginning and the end of the actual urine sample is obtained, which is used to beg
in analyzing the
sample and also to do cleansing and flushing as is described in relation to FIGS
. 3 and 4.
The urine sample is then transported to a filter module 72 which filters the uri
ne sample prior to measurement of the parameters of interest. The filter module
72 is a physical filter module consists of a fine mesh, such as a sieve, to bloc
k out foreign particles in the urine sample and prevent these foreign particles
from interacting with the remainder of the urinalysis apparatus 10. The filter m
odule 72 is optional in some cases. The urine sample is then provided to the sen
sor unit 54 for measurement of various parameters of interest. The sensors in th
e sensor unit 54 sense these various parameters of interest based on whether the
urine sample has certain components and then generate electrical sensor signals
corresponding to sensed parameters of interest. Signal conditioning circuitry t
hen pre-processes the sensed signals to provide reduced noise sensor signals. Th
e pre-processing typically includes filtering and amplification. The conditioned
sensed signals are then provided to the I/O module 64 which digitizes these sig
nals.
In the exemplary embodiment shown in FIG. 2, the sensor unit 52 includes a plura
lity of ion selective electrode sensors 76, a sensor housing 78, and a signal co
nditioning module 80. The ion selective electrode sensors 76 and the sensor hous
ing 78 are described in more detail with respect to FIGS. 7A to 7E. The sensor u
nit 54 also includes an optional temperature sensor 82, which provides a reading
that is directly related to the temperature of the urine sample. A driver 84 an
d an actuator 86 are located close by the sensor unit 54 and are used to control
the expulsion of fluids from the sensor unit 54. It should be noted that in the
embodiments described herein that these types of drivers and actuators are typi
cally implemented using a driver circuit and a solenoid valve. The solenoid valv
e is an integrated electromechanical device along with a pneumatic or hydraulic
valve that is actuated by the device. The driver circuit is an electronic circui
t that provides the required signal to open or close the solenoid valve. The dri
ver circuits can be implemented with a solenoid driver relay automation direct Q
M2N1-D24V with 5 Amp contacts.
The solenoid valves can be implemented with an ASCO 8210G94/238710 12V DC NC sol
enoid valve (11.6 W). Alternative devices such as diaphragm solenoids, can be us
ed as long as they meet specifications to prevent cross contamination of urine s
amples. Prior to measurement, the control module 50 sends a control signal to th
e driver 84 to keep the solenoid valve 86 closed so that when the urine sample i
s provided to the sensor unit 54, it is kept within the sensor unit 54 for an am
ount of time that is sufficient to allow the sensors 76 to sense various compone
nts in the urine sample. Any excess of the urine sample exits the sensor unit 54
via an overflow pipe 88. The sensor signals are then pre-processed by the signa
l conditioning module 80. The control module 50 then provides another control si
gnal to the driver 84 to open the solenoid valve 86 to expel the urine sample fr
om the sensor unit 54.
The signal conditioning module 80 typically includes a bank of signal conditioni
ng circuits. A different signal conditioning circuit is typically used for each
sensor to reduce cross-talk between the sensors. Each signal conditioning circui
t includes a high impedance buffer to isolate a sensor 76 from the I/O module 64
. The high impedance buffer is followed by a low-pass filter to reduce noise, fo
llowed by one or more amplifiers to provide amplification and/or voltage offset.
The signals provided by the sensors 76 are similar to DC signals. Accordingly,
low pass filtering is done to provide additional signal conditioning and filter
out noise. Averaging can also be done in software by the control module 50 to fu
rther remove noise. The measured data is then converted from a voltage value to
a parts-per-million value and is compared to a known concentration, typically in
mmol/L, for normal urine. Those skilled in the art are familiar with how to imp
lement the signal conditioning module 80.
Although the urinalysis apparatus 10 is shown having one sensor unit 52 based on
ISE sensors, it should be understood that it can have a sensor unit that is bas
ed on other types of sensors including a surface plasmon resonance sensor (see F
IG. 8) and a scintillation sensor (see FIGS. 9A-10E) depending on the testing th
at is to be performed by the urinalysis apparatus
10. For instance, there can be different versions of the urinalysis apparatus 10
that are configured to perform certain tests depending on the types of sensors
that are used.
In addition, although only one sensor unit is shown in FIG. 2, which is describe
d in further detail with respect to FIGS. 7A-7E, in alternative embodiments ther
e can be additional sensor units which each use different sensors. For example,
Ion Selective Electrode (ISE) sensors, a Surface Plasmon Resonance (SPR) sensor
or scintillation sensors can be used. Accordingly, there can be embodiments in w
hich there are at least two sensor units having different types of sensors. The
different types of sensors are at least two of an ion selective electrode sensor
, a surface plasmon resonance sensor, and a scintillation sensor. Accordingly, t
here can be different embodiments of the urinalysis apparatus having an ISE sens
or unit and an SPR sensor unit, or an ISE sensor unit and a scintillation sensor
unit, or an SPR sensor unit and a scintillation sensor unit or an ISE sensor un
it, an SPR sensor unit and a scintillation sensor unit. The sensor units can be
coupled in parallel or in series depending on whether the particular tests condu
cted by these sensor units interfere with one another. Also, the use of a serial
or parallel configuration for the different sensor units can result in a more e
fficient implementation of the urine transport assembly and the cleansing fluid
transport assembly.
In some embodiments, additional sensor units can be added which are duplicate se
nsor units to provide some redundancy in the event that one sensor unit having a
certain type of sensor fails. In the event of sensor failure, the urine sample
can then be routed to a "back-up" sensor unit that is operational.
The control module 50 analyzes the sensor data to determine values for the param
eters of interest. The sensors that are used have known transfer functions that
are determined during a one-time calibration and may be periodically updated wit
h ongoing calibration. A given transfer function for a given sensor defines the
relationship between the sensed values and the
corresponding measurements for the parameter of interest. These transfer functio
ns are stored by the control module 50 and used to translate the sensor data to
determine the various parameters of interest. The transfer functions can be stor
ed as lookup tables in the memory of the control module 50. In at least some emb
odiments, a determined value is compared against corresponding normative values
that represent a range of acceptable values found in representative samples of u
rine to determine if the determined values are outside these normal ranges. Any
abnormalities are flagged in the urine test report produced by the urinalysis ap
paratus 10. After measurement, the urine sample is then flushed out of the senso
r unit 54 and provided to the waste assembly 58 for subsequent disposal. The was
te assembly 58 includes a driver 90, a solenoid valve 92, a collection tank 94,
a controller 96, a pump 98, a pipe 100, a drain pipe 102, a connector 104 and an
overflow pipe 106. The control module 50 provides a control signal to the drive
r 90 to open the solenoid valve 92 after the sensor unit 52 has performed a meas
urement on the urine sample. The urine sample is then provided to the collection
tank 94. The controller 96 monitors the amount of urine in the collection tank
94. When the controller 96 determines that the collection tank 94 is close to be
ing full, the controller 96 activates the pump 98 which creates the pressure dif
ferential required to pump the urine from the collection tank 94 through the pip
e 100 and the drain pipe 102 to an external drain pipe 108. Alternatively, the p
ump 98 can be periodically operated to empty the collection tank 94. The pump 98
can be implemented with a Flotec FP0F360AC evacuation pump. The cleansing fluid
transport assembly 56 comprises a connector 110, a main valve 112, a driver 114
, a solenoid valve 116, a distiller 118, a cleansing fluid tank 120, solenoid va
lves 122 and 126, drivers 124 and 128, and output pipes 130 and 132. Alternative
ly, the solenoid valve 116 can be replaced with a pressure regulator to regulate
the fluid pressure in the various pipe assemblies of the urinalysis device 10.
Also, the pump 98 pressurizes the whole system so that liquid can be drawn throu
gh the cleansing fluid transport
assembly 56 and the rest of the pipe assemblies where needed. An external water
source such as a water tap is connected to the cleansing fluid transport assembl
y 56 via the connector 110. The main valve 112 is used to provide water to the u
rinalysis apparatus 10. The water is used for cleansing purposes and will be ref
erred to as a cleansing fluid. In alternative embodiments, an external water sup
ply may not be available proximate to the urinalysis apparatus 10 in which case
the urinalysis apparatus 10 includes a water tank (not shown) to supply the requ
ired water.
The main valve 112 is a manual valve used to allow water from the external water
source into the cleansing fluid transport assembly. In alternative embodiments,
the main valve 112 can be a solenoid valve that is under electronic control. Th
e driver 114 and the solenoid valve 116 provide a first level of control to allo
w or disallow the flow of water into certain components of the urinalysis appara
tus 10. The control module 50 sends control signals to the driver 114 to open th
e solenoid valve 116 during a cleansing mode.
Otherwise, during a measurement mode, the control module 50 sends control signal
s to the driver 114 to keep the solenoid valve 116 closed.
When the solenoid valve 116 is open, water is provided to the distiller 118 to d
istill the water. The distiller 118 can also be referred to as a deionizer. The
distiller 118 is optional depending on the hardness of the water provided by the
water supply source. Although the ISE sensors can get damaged in the presence o
f distilled water, the urinalysis apparatus does not continuously operate with p
urely distilled water, but distilled water can be used momentarily to flush out
the various pipe assemblies and other fluid transport components. The water from
the distiller 118 is provided to the first and second output pipes 130 and 132.
The first output pipe 130 includes the solenoid valve 126 and connects to the i
nlet 14. During various stages of a cleansing mode, the control module 50 provid
es control signals to the driver 128 to open the solenoid valve 126 and inject w
ater into the inlet 14 which then travels through various internal components of
the urinalysis apparatus 10. Otherwise, the solenoid valve 126 is typically mai
ntained in the closed position. The second
output pipe 132 includes the solenoid valve 122 and is connected to the cleansin
g fluid tank 120, which contains a suitable detergent, such as a hospital grade
cleaning detergent. The detergent mixes with the water in the output pipe 132. T
he mixture is also referred to as a cleansing fluid herein. During certain stage
s of the cleansing mode, the control module 50 sends control signals to the driv
er 124 to open the solenoid valve 122 to inject the mixture into the inlet 14. T
he mixture then travels through various internal components of the urinalysis ap
paratus 10. Otherwise, the solenoid valve 122 is typically maintained in the clo
sed position. The connectors 104 and 110 are quick disconnect connectors to easi
ly connect to and disconnect from the external drain pipes. This allows the urin
alysis apparatus 10 to be quickly setup at or removed from a site where it is to
be used. The overflow pipe 106 provides a relief mechanism if the collection ta
nk 94 is full and the pump 98 has not yet been activated or is not operational.
A power supply line is used to provide power to the electronic components of the
urinalysis apparatus 10. The power supply line is a 120 V AC supply line that i
s connected to the power supply control panel 66 that serves as the main power c
ontrol point for a power supply bus. The power supply control panel 66 includes
a number of fuses or circuit breakers (not shown) to protect various components
that connect to the power supply bus from current surges. Accordingly, one end o
f the power supply bus connects to these fuses/circuit breakers and the other en
d of the power supply bus is connected to various components of the urinalysis a
pparatus 10 that require 120 V AC power. For instance, the ventilation fans (not
shown), the control module 50, the USB hub 62, the printer 26, the controller 5
2c and the controller 96 are connected to these fuses/circuit breakers since the
se components require 120 V AC power.
The power supply control panel 66 is also connected to the power supply converte
r unit 68 which converts the 120 V AC power into several different supply voltag
e levels that are required by various components of the
urinalysis apparatus 10. For instance, the power supply converter unit 68 conver
ts the 120 V AC supply line voltage into 12 V, 5 V, and 3 V DC supply voltage le
vels. The power supply converter unit 68 converts the incoming 120 V AC supply l
ine voltage into the different supply voltage levels using appropriate step-down
transformers or converters (not shown) as is commonly known by those skilled in
the art. These different supply voltage levels are then provided as required to
various components of the urinalysis apparatus 10 via a power supply bus 66b. F
or instance power supply bus 66b1 provides 12 V DC power, and power supply bus 6
6b2 provides 24 V DC power. Other portions of the power supply bus provide 120 V
AC power to various components as described above.
Referring now to FIG. 3, shown therein is a schematic diagram illustrating an ex
emplary embodiment of the various components of the urine transport assembly, th
e cleansing fluid transport assembly 56 and the waste fluid transport assembly 5
8. These assemblies include several pipe sections, drivers and solenoid valves.
These assemblies also include t-fittings, cross- fittings, and elbow-fittings as
required. The pipes and fittings can be made from copper, brass, stainless stee
l, polyvinyl chloride (PVC), or any other suitable material which is known to th
ose skilled in the art. The solenoid valves are shown but the drivers are not sh
own for simplicity. The solenoid valves are used in certain sections of the tran
sport assemblies in order to gate the flow of the urine sample through various c
omponents of the urinalysis apparatus 10. The solenoid valves also open or close
in order to allow or disallow cleansing fluid or another type of fluid through
a particular section. The control module 50 controls the actuators. For instance
, at least one electronic valve is configured to gate the flow of the urine samp
le within the urine transport assembly in response to gating commands received f
rom the control module 50.
The components of the urine transport assembly, the cleansing fluid transport as
sembly 56 and the waste fluid transport assembly 58 have been collectively label
ed as pipe sections p1 to p17. Pipe sections that are shown as being
broken because they finish at one portion of FIG. 3 and re-appear at another por
tion of FIG. 3 have dashed reference numerals. For example, pipe sections p3-1 ,
p3-2, p8-1 , p8-2, p13-1 and p13-2 are such pipe sections.
Pipe sections p1 , p4, p5, p6 and p7 along with connector 110, main valve 112 an
d solenoid valves 114, 122 and 126 form a portion of the fluid transport assembl
y 56 that was shown in FIG. 2. Another portion of the fluid transport assembly 5
6 includes pipe sections p2, p3-1 , p3-2, pδ-1 , p8-2, an solenoi valve 150. P
ipe sections p9, p10 along with solenoi valve 152 form the urine transport asse
mbly. Pipe sections p11 , p12, p13-1 , p13-2, p14, p15, p16 an p17, along with
solenoi valves 154 an 156, an pump 98 form the waste transport assembly 58. T
he collection tank 94 is not shown in FIG. 3 but it woul be locate right befor
e the pump 98. The various transport assemblies have been esigne to utilize a
combination of physical orientation, solenoi valves an pumps to transport vari
ous flui s through certain components of the urinalysis apparatus 10. For exampl
e, the main valve 112 is use to control whether water is provi e to the urinal
ysis apparatus 10. Element 114 is a pressure regulator which is use to regulate
the pressure of the flui as it travels through various components uring isin
fect, cleanse an rain mo es (see FIG. 4). The solenoi valve 150 is use to co
ntrol whether cleansing flui is provi e to the sensor unit 54 an subsequent c
omponents of the urinalysis apparatus 10. The solenoi valve 126 is use to cont
rol whether cleansing flui is provi e to the inlet 14 an subsequent component
s of the urinalysis apparatus 10. The solenoi valve 122 is use to control whet
her a etergent is mixe with water an then provi e as a cleansing flui to th
e inlet 14 an subsequent components of the urinalysis apparatus 10 as escribe
below. The solenoi valve 152 is use to control whether the urine sample or cl
eansing flui , that has just cleanse the inlet 14, is provi e to the sensor un
it 54. The solenoi valve 156 is use to control whether air is exhauste from t
he sensor unit 54. The solenoi valve 154 is use to release urine or other flui
s from the sensor unit 54. The pump 98 is also use to remove the urine an the
se other flui s from this portion of the urinalysis apparatus 10.
Referring now to FIG. 4, shown therein is a flow chart iagram illustrating an e
xemplary embo iment of a flow sequencing metho 170 for the urinalysis apparatus
10. The control mo ule 50 operates un er various mo es in which certain flui s
are provi e to various components of the urinalysis apparatus 10. In this examp
le embo iment, the control mo ule 50 operates in a calibration mo e 172, a stan
by mo e 174, a pretest rain mo e 176, a micturition mo e 178, a test mo e 180,
a isinfect mo e 182, a cleanse mo e 184 an a rain mo e 186. This flow sequenc
ing metho 170 has been foun to work well for the SPR sensor unit 54. However,
if other flow sequencing metho s may also be use if another sensor unit such as
an SPR or ra iation sensor unit is use , or if a combination of sensor units ar
e use .
The calibration mo e 172 is optional. The calibration mo e 172 is use epen ing
on whether the sensors that are use by the urinalysis apparatus 10 require per
io ic calibration. For example, some ion selective electro e sensors have a fast
ecaying electro e potential of approximately 8 mV per ay, an require calibra
tion at least once per ay. Accor ingly, in this case, the calibration mo e oes
not have to be one when each urine sample is teste but rather is performe on
ce aily prior to con ucting any urine tests for the ay. Various calibration te
chniques can be use . In one exemplary calibration technique, uring the calibra
tion mo e 172, after a previous isinfect mo e an cleanse mo e, a calibration f
lui is provi e into the sensor unit 54 to allow the sensors 76 to be calibrate
. The calibration flui contains known quantities of the various constituents o
f a urine sample that are to be measure by the sensors 76. During the calibrati
on mo e 172, the sensors 76 etect the levels of these constituents in the calib
ration flui , an provi e the measure levels to the control mo ule 50 as escri
be below in relation to the test mo e 180. The control mo ule 50 uses this cali
bration ata to characterize the sensor outputs that are provi e by the sensors
76, for instance, by generating an storing a transfer function representing th
e
expecte levels of a constituent of the urine for a given measure electrical si
gnal provi e by the sensor 76 that measures that constituent.
To facilitate a iscussion of the other various mo es of the metho 170, a brief
escription of the sensor unit 54 will be provi e . The sensor unit 54 is escr
ibe in more etail with regar s to FIGS. 7A-7E. The sensor unit 54 inclu es a s
ensor housing 190 that has a channel 192 with an inlet 194, an an outlet 196. T
he sensor unit 54 also inclu es an overflow port 198, an an exhaust port 200 fo
r the channel 192. The sensor unit 54 also inclu es several sensor ports 202 wit
h an outer portion that is shape to receive an en of the sensor 76, an an inn
er portion that is large enough to allow the tip of the sensor 76 to protru e o
wn into the channel 192 so that it makes contact with a flui uring use. The se
nsor unit 52 also inclu es caps 204 to plug a sensor port 202 that is not being
use an an access port at the front of the sensor housing 190. During the stan
by mo e 174, some flui is left stan ing within the sensor unit 54 in or er to c
oat the sensors 76 where necessary to prevent the sensors 76 from being amage
when not in use. Also, when the ISE sensors are wet, it takes less time for them
to recover from stan by mo e to begin measuring ata. The stan ing flui is als
o in pipe sections p14 an p15. The stan ing flui is water that is left over af
ter a previous cleanse an rain mo e. There is also water that is in most of th
e sections of the cleansing flui transport assembly 56. The solenoi valves 150
, 126 an 122 are close to keep this water in pipe sections p1 , p2, p4, an p5
. Also, it shoul be un erstoo that the apparatus 10 has been isinfecte , rai
ne an cleanse prior to entering the stan by mo e 174.
When a urine test is being con ucte , the control mo ule 50 configures the urina
lysis apparatus 10 to operate in the pretest rain mo e 176. In this mo e, the s
tan ing water in the sensor housing 190 is rawn out by opening the solenoi val
ve 154. Also, a pre-test flush cycle can be one that both rinses an then empti
es various components with the help of the pump 98. The stan ing water moves fro
m the channel 192 to pipe sections p15, p16
an p17 to the external rain pipe (not shown). The solenoi valves 150, 122 an
126 are maintaine in the close state to prevent the cleansing flui from bein
g rawn into the inlet 14 an the sensor unit 54.
The control mo ule 50 then configures the urinalysis apparatus 10 to operate in
the micturition mo e 178. In this mo e, the user micturates (i.e. urinates) into
the inlet 14. The urine provi e by the user, hereafter referre to as a urine
sample, travels to the flow meter unit 52 via the pipe section p9. If there is a
ny overflow of urine at this point, the urine overflow goes to pipe sections p8-
1 an p8-2. The flow meter unit 52 measures the flow rate an volume of the urin
e sample as it passes through the flow meter unit 52 to the pipe section p10. Al
ternatively, the ata measure by the flow meter unit 52 can be provi e to the
control mo ule 50 which performs these calculations. The solenoi valve 152 is o
pen an the urine sample flows through the inlet 194 into the channel 192 of the
sensor housing 190. The solenoi valve 154 is alrea y close so the urine sampl
e fills up the channel 192 an the pipe section p15. Any overflow of the urine s
ample goes through the overflow port 198 into the pipe section p14 an possibly
through the exhaust port 200 to the pipe section p11 epen ing on the amount an
flow rate of the urine sample. The pump 98 is not active uring the micturition
mo e 178 so as to avoi affecting the uroflowmetric measurements ma e by the fl
ow meter unit 52. In a ition, the solenoi valve 156 is in the open state, ther
eby allowing air within the channel 192 to leave the sensor housing 190 as the u
rine sample is collecte within the channel 192 so as to prevent any bubbles in
the urine sample which may affect the measurements performe by the sensors 76.
The control mo ule 50 then configures the urinalysis apparatus 10 to operate in
the test mo e 180. During the test mo e 180, the sensors 76 in the sensor unit 5
2 are immerse in the portion of the urine sample within the channel 192 to meas
ure one or more parameters of this portion of the urine sample. In alternative e
mbo iments, ifferent portions of the urine sample are channele by an altere v
ersion of the urine transport assembly to several ifferent sensor units that ar
e either in parallel or in series with one another. During
the test mo e 180, the solenoi valve 154 is maintaine in the close position.
The length of time of the test mo e 180 epen s on the type of sensors employe
by the sensor unit 54. This length of time may be two to three minutes for examp
le. The length of the test time can also be etermine base on ata collecte b
y the flow meter unit 52. When the flow meter unit 52 etects that there is no m
ore flui entering the inlet 14, the urinalysis apparatus 10 can give the user a
message on the isplay 18 that urination shoul continue. If urination continue
s, the flow meter unit 52 continues to measure the characteristics of the urine
flow. If urination oes not continue, then the urinalysis apparatus 10 eci es t
hat the user is one an procee s to o test the urine sample an flush the syst
em.
Once sensor measurement has been complete , the control mo ule 50 then configure
s the urinalysis apparatus 10 to operate in the isinfect mo e 182. In this mo e
, a etergent is release from the cleansing flui tank 120. The etergent can b
e a hospital gra e etergent, such as "Triton X100" or "Tween 20" from Sigma-Al
rich, that is use to isinfect the components of the urinalysis apparatus 10 af
ter a urinalysis test has been performe . In this embo iment, the etergent ente
rs the pipe assembly through a special pressure washing valve that opens when th
ere is a flow of water etecte in pipe section p5. The pump 98 helps to acceler
ate the volume of water an etergent through the various pipe sections an othe
r components in the urinalysis apparatus 10 that receive flui .
The etergent travels through pipe section p5 to solenoi valve 122 which is now
opene . Accor ingly, the water that was in pipe section p5 moves to pipe sectio
n p6. The etergent then moves to pipe section p6 as the water moves to pipe sec
tion p7. The water then moves through the inlet 14 to the pipe section p9 an th
e flow meter unit 52. The etergent starts to follow the same path as the water
reaches the inlet 14. The solenoi valve 152 is then opene so that the water ca
n move into pipe section p10 an the channel 192. The etergent is then no longe
r provi e by the cleansing flui tank 120. The etergent follows the path that
the water just took through the pipe
sections p6 an p7 to the inlet 14, pipe section p9, an the flow meter unit 52.
It shoul be note that the timing an uration of the passing of the water an
the etergent through the various components, as escribe in this text an in
the following text can be altere in ifferent embo iments as long as sufficient
isinfection an cleansing is achieve .
When the solenoi valve 152 opens, the solenoi valve 154 also opens so that as
the water enters pipe section p10 an the channel 192, the urine sample flows ou
t of the channel 192 into pipe sections p14, p15 an p16. The etergent then mov
es into pipe section p10 an into the channel 192. Aroun this time, the solenoi
valve 126 is opene so that water moves into pipe section p7 an the inlet 14.
The urine sample continues to be remove an moves through pipe sections p16 an
p17 an the water now moves through pipe sections p9, p8-1 an p8-2 an the e
tergent moves through pipe sections p11 , p14 an p15. As the urine sample is ex
iting through pipe section p17, the etergent is traveling through pipe section
p13-1 , p13-2 an p16. Aroun this time, the water is moving through the channel
192 to pipe sections p14 an p15. When the water has fille up the channel 192,
the solenoi valves 122 an 126 are close . At this point, no new water is prov
i e to flow in pipe sections p6 an p7, an the inlet 14 as the remaining eter
gent an water continues to move through the other pipe sections.
The control mo ule 50 now configures the urinalysis apparatus 10 to operate in t
he cleanse mo e 184. In this mo e, as the previous flow of water passes through
pipe sections p9, p8-1 , p8-2, the flow meter unit 52 an the pipe section p10,
the solenoi valve 152 is close . The solenoi valve 150 is opene to provi e a
new flow of water through pipe sections p3-1 an p3-2 to the sensor unit 54. As
this new flow of water enters the sensor unit 54 an fills up the channel 192, t
he etergent moves out of pipe section p17. This mo e lasts long enough to clean
each of the tips of the sensors 76. In this mo e, water is sent through pipe se
ctions p16 an p17. The cleanse mo e
184 also allows the sensors 76 to be reset to the appropriate equilibrium point
in preparation for the next set of measurements.
The control mo ule 50 now configures the urinalysis apparatus 10 to operate in t
he rain mo e 186. In this mo e, the solenoi valves 152 an 154 are close as w
ater rains through p11 , p13-1 , p13-2, p14 an p16. The solenoi valve 150 is
then close an water continues to rain from pipe section p17, p3-1 an p3-2 un
til stan ing water remains in the channel 192, pipe section p15 an part of pipe
section p14. At this point, the control mo ule 50 operates once more in stan by
mo e. Some water is left stan ing in the sensor unit 54 to prevent the sensors
76 from being amage , for instance, by rying out between tests. Accor ingly, s
ufficient water is left stan ing in the sensor unit 54 so as to coat the sensing
surfaces of the sensors 76. In a ition, in this example, the urine sample an
other flui s are expelle into the external rain. However, in other embo iments
, these flui s can be expelle into the collection tank 94.
In alternative embo iments, some mo es may be repeate or reor ere as require .
 For example, the isinfect mo e 182, the cleanse mo e 184 an the rain mo e 18
6 can be repeate several times to ensure complete isinfection an econtaminat
ion of the urinalysis apparatus 10 between tests. Sensors can be use in these e
mbo iments to etermine if these mo es nee to be repeate . Also, these mo es ma
y be one in between urine tests especially if the time uration between tests i
s long to ensure that the ISE sensors o not become amage . For example, in an
alternative embo iment, the flui flow sequencing can be the following: stan by
mo e 174, isinfect mo e 182, cleanse mo e 184, rain mo e 186, micturition mo e
178, test mo e 180, a secon cleanse mo e 184, a secon rain mo e 186, a secon
isinfect mo e 182, a thir cleanse mo e 184 an a thir rain mo e 186. It sh
oul also be note that the urine sample is typically brought to the various sen
sor units un er the influence of gravity while the cleansing flui s are usually
elivere un er pressure for better cleaning.
Referring now to FIGS. 5A, 5B an 5C, shown therein are perspective an cross-se
ctional views of an exemplary embo iment of the inlet 14 that receives the urine
sample from the user uring micturition. The inlet 14 comprises a funnel 250 an
an outlet port 252. The funnel 250 is configure to receive the urine sample f
rom the user uring micturition. The outlet port 252 is locate along a first po
rtion of the funnel 250 along a lower portion thereof an is configure to provi
e the urine sample to a ownstream element of the urinalysis apparatus 10, in t
his case the pipe sections p9 an in the case of overflow pipe sections p8-1 an
p8-2. The inlet 14 further inclu es an inlet port 254 an a cleansing flui is
tribution element 256. The inlet port 254 is locate along an upper portion of t
he funnel 250 an receives a cleansing flui uring certain mo es of operation a
s previously explaine . The cleansing flui istribution element 256 is locate
along an upper portion of the funnel 250 an provi es a circumferential stream o
f the cleansing flui an a plurality of jets of the cleansing flui when receiv
ing the cleansing flui from the inlet port uring certain mo es of operation. A
s explaine previously with respect to FIG. 4, the cleansing flui is water, a
etergent or a combination of both water an etergent.
The funnel 250 has a generally elliptically shape rim 258, a sloping front wall
260 having a pre etermine inclination 262, a slope back wall 264 that is oppo
site to the front wall 260 an that abuts the front panel of the housing 12.
The back wall 264 is not slope as much as the front wall 260. The funnel
250 also inclu es a pair of si ewalls 266, only one of which is shown, connectin
g the front wall 260 an the back wall 264. The inlet 14 is typically ma e from
stainless steel. However, in alternative embo iments, the inlet 14 can be ma e f
rom glaze vitreous china or any other suitable material.
During the micturition mo e 178, the user's urine enters the funnel 250 through
the mouth of the funnel 250 an is gui e to the outlet port 252 primarily by th
e front wall 260, although the urine may first make contact with at least one of
the back wall 264 an the si ewalls 266. However, it has been iscovere that c
ontact with these walls oes not appreciably affect the
measurements ma e by the flow meter unit 52. The urine sample is then irecte t
o the flow meter unit 52 by the pipe section p9. The inclination 262 of the fron
t wall 260 portion of the funnel 250, the axis of the outlet port 252 an the lo
ngitu inal axis of the pipe section p9 have a slope selecte to transport the ur
ine sample to the flow meter unit 52 primarily using gravitational force to mini
mize interference with the flow characteristics of the urine sample uring mictu
rition so that the flow meter unit 252 can accurately measure the flow character
istics of the urine sample. In a ition, the inclination 262 of the front wall 2
60 is selecte so that the surface of the front wall 260 is substantially parall
el to the estimate trajectory of the urine entering the funnel 250 so as to min
imally affect the flow characteristics of the urine as it passes through the inl
et 14. For example, the inclination 262 is selecte to maximize the flow of the
urine passing through the funnel 250 thereby minimizing any re uction in the flo
w rate of the urine sample. The slope of the walls of the funnel 250 can be sele
cte by con ucting 3D mo eling an using ray analysis to etermine the trajector
y of the urine after it contacts the insi e walls of the funnel 250. The shape o
f the funnel 250 shown in FIGS. 5A-5C was seen to give acceptable results. Furth
er, it was etermine that the trajectory of the urine, once urination begins, w
ill not change for one continuous stream of urine. If there is an interruption i
n the current stream of urine then there will be a continuous stream of urine on
ce urination resumes an it was foun that later streams of urine o not interfe
re with previous streams of urine with regar s to the uroflowmetric analysis tha
t is con ucte . The number of interruptions an volume of urine is measure by t
he flow meter unit 52. In a ition, the height of the inlet 14 is selecte base
on the average height of a male an to allow sufficient space for the male to u
rinate into the inlet 14. For female users, a separate container can be use to
urinate in an the user can then pour the contents of the container into the inl
et 14. Uroflowmetric measurements may not be as much of a concern for female use
rs because they o not experience the prostrate problems that male users experie
nce.
In at least one alternative embo iment, the inlet 14 is shape to accommo ate bo
th men an women. Also, in at least one alternative embo iment, the inlet 14 is
height-a justable. In this case, the inlet 14, the portion of the urine transpor
t assembly connecting the inlet 14 an the flow meter unit 52, as well as the fl
ow meter unit 52 itself are couple to a mechanism that can sli e vertically wit
h respect to the housing of the urinalysis apparatus 10 to change the height of
the inlet 14 while preserving the "gravity-flow" feature of this assembly of com
ponents to allow for accurate urine flow rate measurements. In this case, the co
nnection between the output of the flow meter unit 52 an the sensor unit 54 is
flexible to accommo ate the motion of these components.
The cleansing flui istribution element 256 comprises an inwar ly an ownwar l
y exten ing lip 268 at an upper portion of the funnel 250 to efine a channel 27
0 that circumscribes the upper portion of the funnel 250. The ownwar ly exten i
ng portion of the lip has a plurality of holes 272. The portion of the lip 268 t
hat is closer to the back wall 264 of the inlet 14 is larger than the si e an f
ront portions of the lip 268. The holes 272 generally exten along the entire ci
rcumference of the lip 268. The shape of the cleansing flui istribution elemen
t 256 was chosen to have a larger area near the rear of the funnel 250 (i.e. nea
r the inlet port 254) for cleansing purposes as now escribe .
The inlet port 254 opposes an inner wall 274 of the lip 268 so that, uring a mo
e when a cleansing flui is provi e to the inlet 14 un er pressure, the cleans
ing flui is irecte against the inner wall 274 so that a portion of the cleans
ing flui follows the channel 270 to form a circumferential stream of cleansing
flui which then casca es along the front, back an si ewalls 260, 264 an 266
own to the outlet port 252. Another portion of the cleansing flui that flows al
ong the channel 270 is irecte through the holes 272 to form a plurality of jet
s of cleansing flui . These jets of cleansing flui are spraye against opposing
portions of the walls of the funnel 250 to thoroughly cleanse an , in the case
of etergent, isinfect the funnel 250 after the user
has micturate into the funnel 250. The skewe or asymmetrical shape of the ist
ribution element 256 facilitates this " ual-flow" of the cleansing flui an ens
ures that the inner surface of the funnel 250 is completely cleane . Also, the p
ressure regulator 114 can be use to a just the pressure of the cleansing flui ,
as well as the geometry of the istribution element 256 an the holes 272 to en
sure that the cleansing flui oes not spray outsi e of the funnel 250. In alter
native embo iments, for certain uses of the urinalysis apparatus 10, such as in
a octor's office, where there are traine personnel, prior to urinalysis for a
new user, the traine personnel can fit the inlet 14 with an external liner that
is pre-sterilize in which case the inlet 14 oes not have to be cleanse as of
ten.
Referring now to FIG. 5C, shown therein is an explo e view of the inlet 14. Tri
angular sha ing is use to show surface curvature of the components of the inlet
14. The cleansing flui istribution element 256 inclu es the rim element 258,
the lip element 268 an a first housing element 276. The funnel 250 is place wi
thin the first housing element 276. An en portion of the pipe section p7 is the
n place through aperture 278 an aligne with input port 254 of the funnel 250.
The rim an lip elements 258 an 268 are then attache to the first housing ele
ment 276. The en portion of the pipe section p7 rests on groove 280 of a plate
282 that is attache to the front of the housing of the urinalysis apparatus 10.
An en of the pipe section p18 is sli through aperture 284 of plate 282 an at
tache to the outlet port 252 of the funnel 250. The other en of pipe section p
18 is connecte to the inlet of the flow meter unit 52. A secon housing element
286 is attache to the bottom e ges of the secon housing element 276 an the o
uter e ges of the bottom half of the plate 282. A thir housing element 288 is t
hen attache to the upper e ges of the back half of the secon housing element 2
76 an the outer e ges of the top half of the plate 282.
In an exemplary implementation, the mouth of the funnel 250 can have a wi th of
about 5 inches an the length of the major axis of the mouth of the funnel 250 c
an be on the or er of 9.5 inches. The height of the inlet 14 can
be on the or er of 11 inches. Also, the inlet 14 can be place at a several inch
es below the waist height of the average male height.
Referring now to FIG. 6A, shown therein is a schematic block iagram illustratin
g an exemplary embo iment of the flow meter unit 52. The flow meter unit 52 is c
apable of measuring the flow rate of a liqui moving primarily un er the influen
ce of gravity without a pressure ifferential between an inlet an an outlet. In
a ition, the flow meter unit 52 can be cleanse un er pressure without leakage
. The flow meter unit 52 generally inclu es an intake bucket 300 having an inlet
302 an an outlet 304, a rotating element 306 ispose within the intake bucket
300, an actuator 308 an a sensor unit 310. Various structural components of th
e flow meter unit 52 such as the intake bucket 300 an the rotating element 306
can be ma e from PVC or another suitable material.
The inlet 302 of the intake bucket 300 receives the urine sample from the inlet
14 via the pipe section p9 an the outlet 304 releases the urine sample to the p
ipe section p10 of the urine transport assembly as explaine previously. The rot
ating element 306 is ispose within the intake bucket 300 an has a plurality o
f angle surfaces that rotate at a nominal rotation rate. The actuator 308 inclu
es a motor 308m an control circuitry 308c to control the motor 308m so that it
rives the rotating element 306 to rotate at the nominal rotation rate. The mot
or 308m can be any motor that is suitable for riving the rotating element 306 i
n an energy efficient manner. The motor 308m can be a permanent magnet DC motor.
The sensor unit 310 is configure to sense the rotation rate of the rotating ele
ment 306 an the control circuitry 308c is configure to measure eviations from
the nominal rotation rate in or er to calculate the flow rate of the flui stre
am. During the micturition mo e, the urine sample contacts the rotating element
306 an changes the rate of rotation of the rotating element 306.
The changes in the rate of rotation of the rotating element 306 are proportional
to the flow rate of the urine sample.
The sensor unit 310 inclu es an opto-interruptor mechanism in which light is ir
ecte towar s the rotating element 306 an the rate of reflection or transmissio
n of this light, epen ing on the configuration of the opto- interruptor, provi
es an in ication of the instantaneous rate of rotation of the rotating element 3
06. For example, a rotation rate vane (not shown) can be couple to the motor 30
8m so as to spin at the same rate as the rotating element 306. The rotation rate
vane is typically a serrate isk couple to a rive shaft 324 of the motor 308
m. A light source an a light etector can be place on either si e of the rotat
ing rate vane. The rotating rate vane perio ically interrupts the light path bet
ween the light source, such as a light emitting io e (not shown), an a proxima
te light etector, such as a phototransistor (not shown), in the opto-interrupte
r mechanism. As a result of the perio ic interruption, the phototransistor curre
nt varies at the same rate as the instantaneous rotation rate of the rotational
rate vane, an thus represents the instantaneous rotation rate of the rotating e
lement 306. An example configuration of the circuitry of the opto-interruptor is
shown in FIG. 6D. Alternative metho s of measuring the rotation rate of the rot
ating element 306 can be use as is known by those skille in the art.
The control circuitry 308c inclu es a Phase Lock Loop (PLL) 312, a Pulse Wi th M
o ulate (PWM) control block 314, a clock source 316 an a Data AcQuisition (DAQ
) mo ule 318. The control circuitry 308c, PLL 312, PWM control block 314 an the
clock source 316 can be consi ere to be part of the controller 52c of FIG. 2 w
hile the DAQ mo ule 318 can be consi ere to be part of the I/O mo ule 64. The c
lock source 316 is optional since the flow meter unit 52 can receive a clock sig
nal from an external evice such as the control mo ule 50. The ata acquisition
mo ule 318 is an Analog to Digital Converter (ADC) an the PWM control block 314
can be replace with other types of control blocks executing other types of sui
table control algorithms as is commonly known to those skille in the art. The i
nstantaneous rotation rate (i.e. the signal TACH) sense by the sensor unit 310
is use by the PLL 312 to etermine whether the rotating element
306 is rotating at the nominal rotation rate by comparing the measure instantan
eous rotation rate with the nominal rotation rate. The varying current signal th
at is pro uce by the light etector of the sensor unit 310 is buffere an ampl
ifie to pro uce the TACH signal. The PLL 312 generates a PROCESS signal that en
co es the ifference between the measure instantaneous rotation rate an the no
minal rotation rate generate by the clock source 316 that represents the pre et
ermine spin rate. The nominal rotation rate can be represente by a perio ic si
gnal with an appropriate frequency. For example, for a nominal rotation rate of
1500 revolutions per minute, the perio ic signal generate by the clock source 3
61 has a frequency of 3000 Hz. The PROCESS signal is provi e to the PWM control
block 314 an to the flow rate sensor ata acquisition unit 310. The PWM contro
l block 314 uses the PROCESS signal to a just the rotation rate of the motor 308
m so that it rotates the rotating element 306 at the nominal rotation rate. The
PWM control block 314 controls the rotation rate of the motor 308m by varying th
e uty cycle of a power supply voltage that is provi e to the motor 308m. As a
result, the PROCESS signal provi e by the PLL 306 alters the uty cycle of the
PWM control block 314 to alter the rotation rate of the motor 308m. The generati
on of the PROCESS signal an the a justment of the rotation rate of the motor 30
8m can occur at a rate of 5 Hz.
The PROCESS signal is also converte into igital form by the DAQ mo ule 318 an
transmitte to the control mo ule 50 for uroflowmetric analysis. The sampling o
f the PROCESS signal can occur at a rate of up to 1 kHz. Similar to the other a
ta acquisition units use in the urinalysis apparatus 10, the DAQ mo ule 318 inc
lu es a signal con itioner to filter out noise in the PROCESS signal, an amplifi
er to amplify the filtere signal, an an analog-to- igital converter to perfor
m igitization. The urine falling on the rotating element 306 causes it to lose
rotational momentum since the urine falling on the rotating element 306 a s mas
s to the surface of the rotating element 306. As a result, the ifference betwee
n the measure instantaneous rotation
rate an the nominal rotation rate is proportional to the flow rate of the urine
uring the micturition mo e 178.
Referring now to FIGS. 6B an 6C, shown therein are perspective an cross- secti
onal views of an exemplary embo iment of the flow rate sensor unit 52. The rotat
ing element 306 is a multi-bla e impeller or fan 306' with several bla es that i
ntercept the flow of urine passing through the intake bucket 300. An intake own
spout 320, which is a tube, channels the urine sample such that it flows onto th
e bla es of the multi-bla e fan 306'. The angle of the intake ownspout 320 is s
electe such that the urine continues to move primarily un er the flow of gravit
y to preserve the flow rate properties of the urine sample an is also steep eno
ugh to ensure pre ictable flow velocity. The intake ownspout 320 is also locate
such that the flow of the incoming flui is perpen icular to the surface area
of the bla es or fins of the fan 306'. The motor 308m, the sensor unit 310 an t
he control circuitry 308c are typically house in a seale compartment 322 outsi
e of the intake bucket 300 to protect these components from exposure to flui .
The motor 308m an the multi-bla e fan 306 are couple by a rive shaft 324.
The bla es of the multi-bla e fan 306' are angle to provi e a greater surface a
rea for interaction with the incoming urine. The bla es of the multi-bla e fan 3
06' are fixe to a central member 326 that is rotate by the rive shaft 324 ri
ven by the motor 308m. Each bla e of the multi-bla e fan 306' typically has a re
ctangular shape an is fixe to the central member 326. The bla es exten from a
spinning axis of the multi-bla e fan an are angle with respect to the axis of
the inlet 302 of the intake bucket 300 as well as being angle away from the pl
ane of the central member 326. This allows for increasing the surface area of ea
ch bla e that is available for intercepting the incoming urine. Since the bla es
are angle away from the plane of the central member 326, each bla e can be ma
e larger, an thus have an increase surface area when compare to similarly siz
e rotational elements that o not use bla es. The angle of the bla es is select
e such that the multi-bla e fan captures an eflects the flow of urine consist
ently for the expecte range of
micturition flow rates. In an exemplary embo iment, the bla es of the multi- bla
e fan 306' are fixe to the central member 326 at a 45- egree angle to the rota
tional plane of the multi-bla e fan 306'. Other suitable angles can also be use
. In this exemplary embo iment, seven bla es are use for the multi- bla e fan.
Other suitable numbers of bla es can also be use .
During the micturition mo e 178, the urine passes through the flow meter unit 52
primarily un er gravity an is not subjecte to an input or output pressure to
raw the urine into or out of the flow meter unit 52. Depen ing on the state of
the user, the urine provi e by the user may have a very low flow rate an volum
e. In contrast, uring the isinfect mo e 182 an cleanse mo e 184, much larger
amounts of flui s are flushe through portions of the flow meter unit 52 un er h
igh pressure in or er to effectively isinfect an clean these portions of the f
low meter unit 52. As a result, the mechanical components of the flow meter unit
52 are esigne to han le a wi e range of flui flow rates, pressures an volum
es. For instance, the flow meter unit 52 can generally measure urine flow rates
as low as 1.0 to 1.2 milliliters per secon , while han ling cleansing flui flow
rates as high as 142 milliliters per secon .
The multi-bla e fan 306' has a larger surface area, ue to the use of the angle
bla es, to intercept the urine an as such, allows for increase sensitivity an
accuracy in flow rate measurement which allows for the measurement of low urin
e flow rates that may be encountere when a user micturates. Also, the larger su
rface area of the multi-bla e fan allows the size of the fan itself an the inta
ke bucket 300 to be re uce while still being able to accurately make these flow
measurements. In a ition, a smaller amount of cleansing flui is require to s
ufficiently cleanse the flow meter unit 52. The multi-bla e fan 306' typically c
ontinues to rotate uring the isinfect mo e 182 an the cleanse mo e 184 so as
to enhance the istribution of the cleansing flui within the intake bucket 300.
The intake bucket 300 is also a seale enclose structure so as to prevent any
flui s, an in particular cleansing flui s uring the isinfect mo e 182 an the
cleanse mo es 184, from exiting the flow meter unit 52 other than through the i
ntake bucket outlet 304 un er a
variety of flow rates for these flui s. The outlet 304 is use to connect the fl
ow meter unit 52 to the pipe section p9. In an exemplary implementation the inta
ke bucket 300 can have a iameter on the or er of 4 inches, a height on the or e
r of 5 inches an the multi-bla e fan 306' can be on the or er of 2.5 inches in
iameter for generally opposing bla e tips.
The flow meter unit 52 is typically calibrate uring the manufacturing of the u
rinalysis apparatus 10. The flow meter unit 52 is calibrate by injecting flui s
at known flow rates into the intake bucket 300 an then measuring the resulting
igitize PROCESS signal. This calibration ata is store by the control mo ule
50 an use to etermine the urine flow rate uring the micturition mo e 178 by
comparing the measure value for the PROCESS signal to calibrate values for th
e PROCESS signal an then using the correspon ing store calibration value as th
e measure flow rate.
Referring now to FIG. 6D, shown therein is a schematic circuit iagram of an exe
mplary embo iment of a circuit mo ule 330 that provi es the functionality of the
sensor unit 310 an the control circuitry 308c an can be use with the flow ra
te sensor unit 52. The circuit mo ule 330 inclu es an opto-interruptor stage 332
, an amplification stage 334, a PLL stage 336, a PWM control stage 338 an a clo
ck stage 340. As the rive shaft 324 of the motor 308m turns, vanes mounte onto
the rive shaft 324 interrupt the light path from the LED to the light sensor i
n the opto-interruptor stage 332. The output of the light sensor is the TACH sig
nal, which is a sine-wave like signal whose frequency is proportional to the rat
e at which the motor 308m spins (i.e. a tachometer signal). The amplification st
age 334 provi es a squaring function an converts the output of the opto-interru
ptor stage 332 (i.e. TACH signal) into a square-wave signal that conforms to sta
n ar TTL logic levels. The PLL stage 336 analyzes the square TACH signal an c
ompares it to a stable reference signal of fixe frequency that is provi e by t
he clock stage 340. An attempt to slow the rotating element 306, by the flui fl
ow striking the rotating element, will result in a positive correction signal be
ing generate by the PLL stage 336. The correction signal is sent to the PWM con
trol stage
338, which mo ulates the spee of the motor accor ingly via PWM control. A sampl
e of the correction signal is simultaneously filtere via a 2 Hz LPF an subsequ
ently passe to the DAQ mo ule 318 for further processing by the control mo ule
50. The amplitu e of the correction signal is proportional to flui flow rate. T
he clock stage 340 uses a highly stable, crystal-controlle oscillator whose out
put frequency is ivi e own by igital-logic ivi ers until its final frequenc
y is equal to the nominal tachometric frequency of the motor 308m which can be o
n the or er of 3 KHz for example. The motor is controlle via a linear power amp
lifier that is biase full-on/full-off (i.e. it acts as a switch to issipate li
ttle heat) an pulses at a rate relate to the reference clock. The PLL stage 33
6 mo ifies the pulses of the linear power amplifier as require to mo ulate a co
ntrol signal accor ing to the PWM control technique. The mo ulate control signa
l is sent to the motor 308m.
Referring now to FIGS. 7A an 7B, shown therein are perspective an en views of
an exemplary embo iment of a sensor housing 350 that can be use for the sensor
unit 54. The sensor housing 350 has a bo y 352 that is a apte to efine an int
ernal channel (not shown) for receiving a urine sample or cleansing flui . The b
o y 352 is further a apte to efine an inlet port 354 for the channel, a plural
ity of sensor ports 356, an access aperture 358 (use for maintenance purposes),
an air exhaust port 360 an an overflow port 362.
The bo y 352 is further a apte to efine an outlet port (not shown) for the cha
nnel. The inlet an outlet ports are generally efine at opposing en s of the c
hannel. The bo y 352 can be ma e from at least one of aluminum, acrylic or other
suitable plastic. The sensor housing 250 is esigne to be easily sli into or
out of place. This allows the sensor housing to be easily remove an re-inserte
for maintenance.
The channel exten s longitu inally through the bo y 352. The channel is size to
have a volume that can accommo ate the minimum amount of urine require for an
accurate urinalysis test by the sensors 76. However, other volumes can also be u
se that allow for accurate sensor measurement. In use, flui s enter the channel
through the inlet port 354 an the flui s exit the
channel through the output port 366. Excess flui exits the bo y 350 though the
overflow port 362. The air exhaust port 360 allows air to be vente out of the c
hannel when a flui is filling the channel.
The sensor ports 356 are efine in an upper portion of the bo y 352 an receive
the sensors 76. Each of the sensor ports 356 has a respective sensor port bore
that exten s from the upper portion of the bo y 352 to the channel.
Each of the sensor ports 356 has an outer portion at the upper surface of the bo
y 352 efine to releasably an securably receive a sensor an an inner portion
terminating at the channel to position a sensing en of the sensor within the c
hannel such that the sensing en is at least partially immerse in the flui tha
t is in the channel uring use. The sensor ports 356 can have ifferent sizes to
accommo ate sensors of ifferent sizes.
The sensor ports 356 are istribute along the longitu inal length of the bo y 3
52, an a jacent sensor ports 356 are alternately ispose on opposing angle su
rfaces of the bo y 352 to form a "V" configuration. The axes of a jacent sensor
ports 356 form an acute angle. The a jacent sensor ports 356 are also offset fro
m one another in the longitu inal irection of the bo y 352. For instance, in on
e exemplary embo iment shown in FIG. 7B, the axis 356a of one sensor port 356 is
offset at a 20 egree angle with respect to the vertical axis 352v of the bo y
352 that passes through the central axis of the channel, while the axis 356a' of
an a jacent sensor port 356 (not shown in FIG. 7B) is offset at a -20 egree an
gle from this vertical axis 352v. Other angles can also be use provi e there i
s enough space for the en s of the sensors that are not inserte into the bo y 3
52. The offset positions of the sensor ports 356 allow sensing en s of the senso
rs 76 to be positione generally in a line within the channel an irectly in th
e channel to be immerse in the flui in the channel without the sensing en s to
uching one another, while allowing the bo ies of the sensors 76 to be place in
a more compact fashion within the sensor unit 54. Accor ingly, the offset positi
ons of the sensor ports 356 allows for the size of the channel to be re uce whi
le still being able to accommo ate the plurality of sensors. This
results in a re uction of the volume of urine that is require in the channel fo
r accurate urinalysis testing. However, while the offsets allow the sensors 76 t
o be place close together, a certain egree of separation between the sensors 7
6 is still require to re uce interactions between sensors 76 an to allow for m
aintenance of the sensors 76. Sensors are replace perio ically, such as yearly
for example, epen ing on the type of sensor that is use . Some types of sensors
are refutable while other types of sensors require complete replacement.
The bore of the sensor ports 356 generally have threa e sections to allow for e
asy insertion an removal of a sensor. The bores of the other ports of the bo y
352 that are connecte to various components of the transport assemblies of the
urinalysis apparatus 10 also generally have threa e sections to facilitate easy
assembly an isassembly as well as to make a secure connection. In alternative
embo iments, the sensor ports 356 an the other ports of the sensor bo y 352 ca
n be shape to provi e pressure fit connections for engaging the sensors 76 an
the various components of the transport assembly respectively or other suitable
connections as is well known by those skille in the art.
In one exemplary embo iment, typical imensions for the various parts of the sen
sor housing 350 are as follows. The sensor housing 350 can have a length on the
or er of 10 inches, a wi th of about 1.6 inches, an a height of about 2.7 inche
s. The iameters of the sensor ports can be on the or er of
0.7 inches for the inner portion an about 1.1 inches for the outer portion an
can vary epen ing on the geometry of the ISE sensors 76. The channel can have a
iameter on the or er of 0.75 inches with the longitu inal axis being locate a
bout 1.25 inches from the top of the sensor housing 350.
Referring now to FIGS. 7C an 7D, shown therein are perspective an cross- secti
onal en views of the sensor bo y 352 having sensors inserte into the sensor bo
y 352. The sensor housing 350 is configure for use with ion selective electro
e sensors, each of which etects a particular ionic species in a flui . Other ty
pes of sensors may also be use as long as they conform to
the mechanical specifications of the sensor housing 350 an are able to withstan
the pressure of the liqui s in the channel that are generate uring cleansing
of the urinalysis apparatus 10. Also shown are an inlet connector 364, an outle
t connector 366, an an overflow connector 368 to facilitate connection to vario
us components of the urine transport assembly an the waste assembly. A plug 370
is also shown for sealing the channel. The plug 370 is removable so that the ch
annel can be inspecte for maintenance purposes.
A bank of Ion Selective Electro e sensors (ISEs) is use to etect an analyze a
number of the constituents of the urine sample. In this example embo iment, the
bank of ISEs inclu e a pH ISE 372 that measures the aci ity of the urine, a so
ium ion ISE 374, a chlori e ISE 376, a potassium ISE 378, a nitrite ISE 380, an
an ammonium ISE 382 as shown in FIG. 7C.
Accor ingly, this particular sensor configuration allows for the measurement of
the aci ity of the urine sample, an the levels of so ium, chlori e, ammonium, p
otassium, an nitrite ions present in the urine sample. However, it shoul be un
erstoo that other ISEs can be use an ifferent embo iments can have ifferen
t combinations of ISEs. The size of the sensor housing 350 can be mo ifie to ac
commo ate a larger or smaller number of ISEs. Any unuse sensor ports (not shown
) are plugge .
As previously escribe , these ISEs are couple to the sensor ports 356 such tha
t their sensing en s are positione within the channel such that they are immers
e in the flui s present within the channel. Since the sensors are arrange in a
n alternating or zig-zag pattern, the sensors can be place closer together with
out the sensing en s hitting one another in the channel which allows the channel
an the sensor housing 350 to be smaller as well as the volume of urine that is
require for testing by the ISE sensor unit 52.
Other sensors that can be use in the urinalysis apparatus 10 inclu e a temperat
ure etector (see FIG. 2), a surface plasmon resonance sensor (see FIG. 8), a sc
intillating sensor (see FIGS. 9A-10E) for etecting ra ioactive constituents in
urine, an a colorimetric sensor (not shown) for etecting
opacity levels. The colorimetric sensor can be inserte into one of the spare po
rts on the sensor housing 350.
Referring now to FIG. 7E, shown therein respectively are a si e view of an exemp
lary embo iment of an ISE sensor 390 that can be use with the sensor housing 35
0 an an explo e view of an exemplary embo iment of an a aptor use to connect
the sensor 390 with the sensor housing 350. The sensor 390 has a sensing en 392
that is typically ma e of glass or a polyvinyl chlori e (PVC) or a combination
of PVC an silicone. The sensor 390 also has a wire 394 exten ing therefrom for
connection to a signal con itioning mo ule for signal con itioning an igitizat
ion for later analysis. The sensor 390 is place within a sensor a aptor 396 tha
t encases a portion of the sensor 390 to allow it to be couple to the sensor po
rt 356. The sensor a aptor 396 allows sensors 390 of varying sizes to be use wi
th the sensor bo y 350. The sensor a aptor 396 has a threa e connector 398 that
engages with complementary threa s on a sensor port 356 of the sensor housing 3
50 to couple the sensor 390 to the sensor port 356. The sensor a aptor 396 furth
er inclu es a sealing ring 400 that is use to prevent flui s within the channel
from exiting the sensor housing 350 by closing any gaps between the sensor 390
an the sensor a aptor 396. The sensor a aptor 396 has a secon threa e connect
or 402 that engages complementary threa s (not shown) on a sensor a aptor cap 40
4 that is couple to the sensor a aptor 396 for compressing the sealing ring 400
against the sensor 390 thereby provi ing a flui -proof seal.
Referring now to FIG. 8, shown therein is a schematic iagram of an exemplary em
bo iment of a Surface Plasmon Resonance (SPR) sensor unit
450 that can be use with the urinalysis apparatus 10 to etect certain componen
ts of interest in the urine sample such as biomolecules. The SPR sensor unit 450
allows for the measurement of molecules of interest without manual sample colle
ction an any sample pretreatment an without interference with the SPR etectio
n sensitivity, specification an repro ucibility. As previously mentione , the S
PR sensor unit 450 can be
use alone, in combination with the ISE sensor unit 54 or in combination with ot
her sensor units. The SPR sensor unit 450 generally inclu es an SPR sensor 460,
a flow cell 462 abutting a sensing surface of the SPR sensor 460 to provi e a fl
ui over the sensing surface uring use, an an imaging system couple to the SP
R sensor 460 an configure to measure changes on the sensing surface ue to the
channele flui . The imaging system generally comprises a light source 452 that
pro uces a laser beam 454, a polarizer 456, a prism 458 an a light etector 46
4. The light etector 464 is connecte to the control mo ule 50. The SPR sensor
unit 450 also inclu es various components that are use to provi e an transport
various flui s that are nee e for testing, cleaning, calibration an regenerat
ion. The SPR sensor unit 450 inclu es a urine sample container 466, a buffer sol
ution container 468, a regeneration flui container 470, a calibration flui con
tainer 472 an a cleansing flui container 474. Some of the components may be sh
are with the cleansing flui transport assembly 56. The SPR sensor unit 450 als
o inclu es a flui transport assembly couple to the flow cell 462. The flui tr
ansport assembly inclu es a flui elivery assembly that transports urine sample
s an other flui s to the flow cell 462 an a flui expulsion assembly that tran
sports the urine sample an these other flui s way from the flow cell 462 when t
hey are no longer nee e . The flui elivery assembly an the flui expulsion as
sembly inclu e a buffer solution flui pump 476, a three way valve 478 to be abl
e to refill the pump 476, an injection valve 480, a flui injection pump 482, a
flui valve 484, the collection tank 94 an the piping components nee e to conn
ect all of these components.
The flow cell 462 abuts a sensing surface of the SPR sensor 460 to channel vario
us flui s over the sensing surface. The sensing surface of the SPR sensor 460 is
a functionalize biochip that can etect one or more of a number of biomolecule
s of interest, such as, but not limite to C-reactive protein, prostate specific
 antigen, human immuno eficiency virus, an human chorionic gona otropin molecul
es. In the exemplary embo iment, the
sensing surface of the SPR sensor 460 is functionalize to etect an array of an
tigens, antibo ies, an DNA fragments. For example, the SPR sensor 460 can be co
nfigure to etect at least one of a c-reactive protein, a prostate specific ant
igen, a human immuno eficiency virus, an a human chorionic gona rotropin in the
channele urine sample. Those skille in the art are knowle geable in terms of
how to configure the SPR sensor 460 to etect such elements. The flow cell injec
tion valve 480 is couple to an intake port of the flow cell 462 to selectively
provi e one of a number of ifferent flui s that are to be injecte into the flo
w cell 462. The output of the flow cell 462 is couple by a piping mechanism to
the collection tank 94 to allow the various flui s to be remove after use.
The light source 452 irects the laser beam 454 through the polarizer 456 to pro
vi e a polarize light beam 486 that enters a facet of the prism 458. The prism
458 is couple to the sensing surface of the SPR sensor 460 to allow the polariz
e light beam 486 to be irecte towar s an reflecte from a thin metal film (n
ot shown) eposite on the sensing surface of the SPR sensor 460 thereby generat
ing a resonance of the plasmons on the sensing surface of the SPR sensor 460. Th
e reflecte light beam 488 exits through another facet of the prism 458 an is
etecte by the light etector 464, which can be a charge couple evice camera f
or example. The light etector 464 recor s the reflecte image of the sensing su
rface of the SPR sensor 460 an provi es this image ata to the control mo ule 5
0 for subsequent processing an analysis. The sensing surface of the SPR sensor
460 can be calibrate against a non-functionalize sensing surface (not shown) i
t or er to compensate for backgroun noise in the SPR sensor 460 cause by a var
iety of nonspecific interactions.
The sensing surface of the SPR sensor 460 can be implemente with a microarray,
which is a stan ar chemistry mo ule that can be use to etect molecules of int
erest. The urine sample will flow over the microarray via the flow cell 462. The
microarray inclu es many separate istinct elements that can each etect a mole
cule of interest when the urine sample flows over the
sensing surface of the SPR sensor 460. Accor ingly, the microarray substrate is
functionalize in ivi ually with ifferent functional molecules so that the SPR
sensor 460 can etect all of the esire con itions/molecules. The microarray ca
n be purchase off the shelf or it can be custom ma e. The flow cell 462 is an a
crylic block that is rill-tape an machine to provi e a flui chamber with a
esire volume so that the microarray is continuously submerge in either a buff
er solution or a urine sample that is being teste as well as other flui s which
are use at times for cleansing an regeneration as explaine in further etail
below. The microarray ensures the elimination of non-specific interactions an
other interferences by using the principle of specific antigen-antibo y interact
ion. The elimination of these interactions an interferences can also be accompl
ishe by using a ifferential measurement between target an reference spots on
the microarray with or without the complementary antigen or antibo y on the same
sensing surface but at a ifferent 2D location. Furthermore, some reagents can
be use to block or voi the non- specification interaction an other interactio
ns uring functionalization of the sensing surface of the SPR sensor 460 an ur
ing the measurement of the urine sample. In an alternative embo iment, a multi-c
hannel format can be use for the sensing surface of the SPR sensor 460 in which
each channel inclu es a separate microarray. Some of these separate microarrays
in the ifferent channels can be i entical to provi e re un ancy as well as to
improve the accuracy of the measurements by making measurements of certain molec
ules of interest more than once.
During the test mo e, when a portion of the urine sample flows over the sensing
surface of the SPR sensor 460, the molecules that are to be etecte bin to cor
respon ing antibo ies on the sensing surface of the SPR sensor 460, thereby chan
ging the resonance properties of the sensing surface of the SPR sensor 460, an
hence changing the refractive in ex of the sensing surface. This change in the r
efractive in ex is etecte by the light etector
464 when a certain type of light is provi e to the sensing surface of the SPR s
ensor 460, which allows for the etection an measurement of the levels of the m
olecules of interest that are present in the urine sample.
The ifferent types of flui s that are injecte into the flow cell 462 inclu e u
rine, a buffer solution that serves as a carrier for the urine being teste , a r
egeneration flui for regenerating the sensing surface of the SPR sensor 460 aft
er each urinalysis test, an cleansing an calibration flui s. The type of flui
s that are injecte into the flow cell 462 epen s on the particular mo e of ope
ration of the urinalysis apparatus 10. During the test mo e, the buffer solution
flui pump 472 injects a buffer solution from the buffer solution container 468
into the flow cell 462 through the injection valve 480. The buffer solution is
pumpe such that it brackets the urine sample being teste in or er to ensure th
at there are no air bubbles present in the flow cell 462. Accor ingly, the buffe
r solution is injecte into the flow cell 462 before an after the urine sample
is injecte into the flow cell 462. Stan ar commercial buffer solutions with a
PH of aroun 7, such as a phosphate buffer solution, can be use epen ing on th
e analytes (i.e. molecules of interest) to be teste . However, a minor effect on
the measurement may result in terms of sensitivity an repro ucibility with if
ferent buffer solutions for ifferent analytes of interest. Accor ingly, the buf
fer solution that is use may nee to be experimentally optimize for the best m
easurement results. Once the measurement has been ma e, the sample is pumpe to
the collection tank 94.
The flui injection pump 482 pumps one of the urine being teste , the regenerati
on flui , the calibration flui an the cleansing flui into the flow cell
462 through the injection valve 170 as is require . The urine un er test is prov
i e by the urine sample container (USC) 466 which receives the urine from the i
nlet 14 via a connection (not shown) to the urine transport assembly shown in FI
G. 3. The SPR sensor unit 450 oes not require as much of the urine sample as th
e ISE sensor unit 52 since the SPR sensor unit 450 requires a urine sample volum
e on the or er of microlitres while the ISE
sensor unit requires a urine sample volume on the or er of milliliters. The rege
neration flui is provi e by the regeneration flui container (RFC) 470. The ca
libration flui is provi e by the calibration flui container (CFC) 472. The re
generation an cleansing flui s are selecte base on the particular SPR sensor
460 that is in use. The cleansing flui is provi e by a cleansing flui contain
er 474 an a cleansing flui transport assembly (not shown). The regeneration fl
ui container 470, the calibration flui container 472 an the cleansing flui c
ontainer 474 are perio ically refille such as uring maintenance for example. T
he flui valve 484 couple between the flui injection pump 482 an the urine sa
mple container 466, the regeneration flui container 470, calibration flui cont
ainer 472 an cleansing flui container 474 is configure by the control mo ule
50 to control which flui is pumpe to the flow cell 462 epen ing on the mo e o
f operation.
The urine sample container 466 receives urine uring the micturition mo e 178. I
n embo iments which employ multiple sensor units, the urine sample can be channe
le to the urine sample container 466 from the inlet 14 an a portion of a urine
transport assembly uring micturition, or it can be channele to the urine samp
le container 466 from another sensor unit after that sensor unit has finishe te
sting the urine sample. For example, with the embo iment shown in FIG. 3, the ur
ine sample container 466 can be the pipe section p15 that imme iately follows th
e sensor housing 190. The pipe section p15 fills with urine uring the micturiti
on mo e as valve 154 is maintaine in the close position. Accor ingly, another
pipe as well as a valve can be attache to pipe section p15 to provi e a portion
of the urine sample to the SPR sensor unit 450. Other configurations are also p
ossible.
The regeneration flui is injecte into the flow cell 462 by the flui injection
pump 482 after a test has been complete in or er to regenerate the sensing sur
face of the SPR sensor 460. The regeneration flui is a tailor-ma e solution tha
t issociates any bon ing of the molecule of interest an removes the molecules
of interest from the sensing surface of the SPR sensor 460; this waste is then s
ent to the collection tank 94. For instance, when the molecule
of interest is an antigen, the regeneration flui s enatures an removes the ant
igen molecules that are boun to the antibo y molecules on the sensing surface o
f the SPR sensor 460. The sensing surface therefore becomes functionalize (i.e.
regenerate ) an is rea y for the next sample measurement. The regeneration flu
i thus allows the SPR sensor 460 to be reuse after each test. The regeneration
flui is typically injecte into the flow cell 462 after the isinfect mo e 182
an before the cleanse mo e 184. The regeneration solution can vary an have i
fferent composition, for example a basic or an aci ic solution, an has to be ex
perimentally optimize for ifferent analytes. The regeneration solution can be
purchase off the shelf or custom evelope . After regeneration, the buffer solu
tion, which acts as the storage solution uring stan by, is pumpe to the flow c
ell 462.
The cleansing flui is injecte into the flow cell 462 by the flui injection pu
mp 482 after a test has been complete in or er to clean the injection valve 480
, the flui injection pump 482, the valve 484 an the flow cell 462. The cleansi
ng flui is provi e to these components as part of the isinfect an cleanse mo
es 182 an 184. The ISE sensor unit 52 an the SPR sensor unit 450 generally ha
ve a separate cleansing an regeneration cycle that are not relate to one anoth
er. The calibration flui is injecte into the flow cell 462 by the flui inject
ion pump 482 to perio ically calibrate the SPR sensor 460 as well as to perform
calibration when a new SPR sensor 460 is inserte , as explaine below. Calibrati
on is one after the isinfect, cleanse an rain mo es 182, 184 an 186 have be
en performe . Calibration can be one perio ically such as once per ay. Althoug
h regeneration flui is provi e to the SPR sensor 460 to regenerate an prolong
the use of the SPR sensor 460, after a certain perio of time, or number of tes
ts, the SPR sensor 460 will lose its sensitivity an can no longer be use . Acco
r ingly, the SPR sensor unit 450 further inclu es an SPR sensor replacement mech
anism 490 which automates the removal of a worn- out or amage SPR sensor 460 w
ith a new SPR sensor. The SPR sensor replacement mechanism 490 can remove the cu
rrent SPR sensor 462 an
insert a new SPR sensor that it obtains from a repository of replacement SPR sen
sors 492. The control mo ule 50 can perform perio ic calibration tests on the SP
R sensor 460 to etermine whether it requires replacement.
Ra ioactive materials can amage a person's bo y through internal an external e
xposure. Internal exposure inclu es inhalation, ingestion an absorption through
an open woun of a ra ioactive substance. Ra ionucli es that have entere the p
erson's bo y can either be soluble or insoluble in bo y flui s. Since a large pe
rcentage of ra ionucli es that enter a person's bo y are excrete in the first f
ew ays, one technique to etect the internalization of ra ioactive substance is
to test for soluble (i.e. transportable) ra ionucli es that have entere the bl
oo stream an will be eliminate through urinary excretion. For example, after
tritium is inhale or absorbe through a person's skin, it istributes equally i
n all bo y liqui s, such as the bloo , saliva, sweat or urine of the person. It
usually takes about 2 hours for tritium to reach the same concentration in all o
f these bo y flui s after which it is stea ily eliminate . Tritium has an effect
ive half-life of 10 ays. Accor ingly, one approach to etect whether a person h
as been expose to tritium is to test the person's urine.
Referring now to FIG. 9A, shown therein is a schematic block iagram of an exemp
lary embo iment of a ra iation sensor unit 500 that can be use with the urinaly
sis apparatus 10 to etect certain ra ioactive components in the user's urine sa
mple. The ra iation sensor unit 500 can i entify ra iation contamination of the
user if the user was expose to beta emitters such as tritium (H-3), ra io-io in
e (1-131), an ra io-carbon (C-14). The ra iation sensor unit 500 can be use al
one or in combination with one or both of the
ISE sensor unit 54 an the SPR sensor unit 450 as well as in combination with ot
her sensor units.
The ra iation sensor unit 500 inclu es a scintillator flow cell 502, an optical
interface (i.e. light pipe) 504, a photomultiplier 506, a shiel element 508, si
gnal con itioning circuitry inclu ing a charge amplifier 510, a Gaussian shaping
amplifier 512, an a pulse height analyzer 514. The pulse height
analyzer 514 will typically inclu e an ADC; otherwise a separate ADC is use . A
transport assembly consisting of pipe elements, valves an the like is require
to transport the urine sample an cleansing flui s to the ra iation sensor unit
500. This transport assembly can be connecte to the urine transport assembly an
cleansing assemblies escribe earlier in relation to FIG. 3 an may be connec
te in a similar fashion as was escribe for the SPR sensor unit 450. Also, a p
ump, such as a peristaltic pump, is typically use to pump the urine sample thro
ugh the scintillator flow cell 502.
Generally, the scintillator flow cell 502 receives a flui sample, in this case
a urine sample, an pro uces a photon light signal in proportion to the ra ioact
ive components inclu e in the flui sample. The light pipe 504, the photomultip
lier 506 an shiel element 508 form a photoelectric conversion mo ule that conv
erts the photon light signal into a photoelectric signal an amplifies the photo
electric signal. The charge amplifier 510 an the Gaussian shaping amplifier 512
are electrical circuitry that further amplify the photoelectric signal to pro u
ce a pre-processe electrical signal. The pulse height analyzer 514 is an analyz
er that etermines whether there are ra ioactive components in the flui sample
an provi es an in ication of the concentration an type of ra ioactive componen
ts. The scintillator flow cell 502 inclu es a bo y 516 a apte to efine several
channels 518, fittings 520 which are inserte into the channels 518 an a flui
transport pipe 522 to transport flui along various portions of the scintillato
r flow cell 502. Due to the high sensitivity of the photomultiplier 506, these c
omponents are house in a light free chamber that has a ark (i.e. light- proof)
casing, which is iscusse further with regar s to Figures 10A-10E.
The configuration of the ra iation sensor unit 500 allows for the ra iation sens
or to be essentially in irect contact with the urine sample, an to receive the
urine sample in an automate fashion. Accor ingly, this operation oes not requ
ire a reagent or pretreatment of the flui sample, thereby re ucing the material
s use . Accor ingly, there is also no significant time elay between submission
of the flui sample an obtaining test results, which overcomes
waiting perio s uring emergency situations an me ical emergencies such as ra i
ation spills.
The scintillator flow cell 502 is ma e from a material that absorbs high-energy
(i.e. ionizing) charge -particle ra iation an then fluoresces photons at a char
acteristic Stokes-shifte (i.e. longer) wavelength releasing the previously abso
rbe energy. Accor ingly, the scintillator flow cell 502 will fluoresce upon exp
osure to a flui having ra ioactive components. The configuration of the scintil
lator flow cell 502 an the flui transport pipe 522 increases the sensitivity o
f the ra iation sensor unit 500 since the urine sample is route an re-route t
hrough various portions of the scintillator flow cell 502 allowing for more inte
raction between any ra ioactive particles in the urine sample an the scintillat
or flow cell 502 to encourage a higher level of scintillation.
Referring now to FIGS. 9B to 9E, shown therein are various iagrams of the scint
illator flow cell 502. In this exemplary embo iment, the bo y 516 of the scintil
lator flow cell 502 is ma e from a soli plastic scintillator ro ma e from a ty
pe of material with a certain sensitivity an is selecte base on etection cri
teria. For example, the material can be selecte to provi e a high photon count
for weak, 2 keV beta particles (e.g. tritium).
The channels 518 are forme in the bo y 516 an the fittings 520 are inserte at
both en s of each channel 518. The channels 518 are shown ispose in a circula
r fashion along the perimeter of a circle. The fittings 520 can be ma e from pla
stic. The flui transport pipe 522 is inserte through the fittings
20 into the channels 518. The fittings 520 provi e a tight fit to hol the flui
transport pipe 522 in place once it has been inserte . In an example embo iment
, the bo y 516 has a height of 50 mm an a iameter of 50 mm, an has eight chan
nels each having a iameter of about 5 mm. The channels are locate along the pe
rimeter of a circle having a ra ius of 16 mm. In alternative embo iments, anothe
r configuration can be use for the scintillator flow cell 502. For instance, a
ifferent shape can be use for the bo y, a ifferent number of channels 518 can
be use , a ifferent iameter can be
use for the channels 518 an the flui transport pipe 522 can traverse the chan
nels in a ifferent serial sequence.
The flui transport pipe 522 interconnects the various channels 518 in series. T
he number of channels 518 an the loope configuration of the flui transport pi
pe 522 increases the surface area contact between the urine sample an the scint
illator material of the scintillation flow cell 502 as well as the amount of tim
e that the material is expose to the urine sample, since the urine sample trave
ls through all of these channels 518 in series. The loope configuration of the
flui transport pipe 522 facilitates cleansing in that it re uces backwash resi
uals an re uces specimen resi uals. The flui transport pipe 522 can be ma e fr
om a flexible material, such as Tygon™ tubing having an internal iameter of 3/1
6" for example. Other types of material, such as a ifferent PVC material, can b
e use for the flui transport pipe 522 as long as the material is flexible enou
gh to be withstan the flui pressure elivere by a pump, such as a peristaltic
pump, be flexible enough to be passe through the channels 518 an not break ow
n ue to exposure to various components in the urine sample or other flui s that
will be pumpe through the flui transport pipe 522.
The light photons that are emitte by the scintillator flow cell 502, upon expos
ure to ra ioactive components in the urine sample, are then transporte via the
light pipe 504 to the photomultiplier 506, which acts as a photo etector to conv
ert the transporte photon light signal into a photoelectric signal (i.e. photoe
lectrons) an amplifies the photoelectric signal. The light pipe 504 can be ma e
from Perspex™, which is a non-quenche acrylic 'glass' with an in ex of refract
ion that matches the in ex of refraction of the scintillator flow cell 502 to i
eally provi e lossless transmission of scintillate light from the scintillator
flow cell 502 to the photomultiplier 506. The light pipe 504 is ma e to have a c
ertain geometry to provi e i eally lossless coupling between the scintillator fl
ow cell 502 an the photomultiplier 506. The photomultiplier 506 is an ultra-low
noise photomultiplier with an integrate ivi er network. The photomultiplier 5
06 can be an off-the-shelf component.
The photomultiplier 506 is configure to multiply the number of photoelectrons b
y a factor of at least 1 million. The output signal of the photomultiplier 506 i
s an electron charge pulse signal. The shiel element 508 is essentially a ferro
magnetic shiel that shiel s the generate photoelectrons from external magnetic
fiel s or charge particles. The shiel element 508 typically exten s over the
entire extent of the photomultiplier 506 an also covers at least part of the li
ght pipe 504 as shown. However, in other embo iments the shiel element 508 can
fully cover the light pipe 504 as well as the scintillation flow cell 502. In th
is case, the shiel element 508 also shiel s particle-emission trajectories, ema
nating from ra ioactive sources in the urine sample, against influence from exte
rnal magnetic fiel s.
The electron charge pulse signal that is output by the photomultiplier 506 is th
en provi e to the charge amplifier 510 which provi es a first amount of gain. T
he charge amplifier 510 has a programmable gain in the range of 5 to 30 an a fa
st rise time of less than 30 ns. This amount of exponential ecay facilitates po
st-Gaussian amplification. The output signal of the charge amplifier 510 is then
further amplifie by the Gaussian shaping amplifier 512. The Gaussian shaping a
mplifier 512 has a programmable gain in the range of 2 to 10 an also shapes the
pulses in the output signal of the charge amplifier 510 to provi e a Gaussian r
esponse. The Gaussian shaping amplifier 512 is use because it facilitates peak/
hol etection that is one by the pulse height analyzer 514 when implemente by
certain types of Multi-Channel analyzers (MCAs).
The output signal of the Gaussian shaping amplifier 512 is then provi e to the
pulse height analyzer 514. The pulse height analyzer 514 counts pulses to istin
guish between the ifferent types of ra iation (i.e. beta versus gamma or alpha
ra iation). The pulse height analyzer 514 can also construct a histogram to ete
rmine the equivalent concentration of the ra ioactive elements in the urine samp
le. The pulse height analyzer 514 can be implemente with an MCA. The pulse heig
ht analyzer 514 increments pulse counts for pulses of certain heights in the out
put signal of the Gaussian
shaping amplifier 512. In one implementation, the pulse height analyzer 514 has
a 4K pulse-height capability. The ICS-4KPCI mo el available from Spectrum Techni
ques can be use to implement the charge amplifier 510, the Gaussian shaping amp
lifier 512, an the pulse height analyzer 514. The control mo ule 50 receives th
e pulse-height ata from the pulse height analyzer 514 an analyzes this ata to
etermine whether there are any ra ioactive components in the urine sample, an
if so, etermine what the source of ra iation is. The pulse height analyzer 514
typically constructs a table of pulse height versus counts. The control mo ule
50 can analyze this information to etermine various characteristics about the r
a iation source such as type an concentration. In alternative embo iments, the
pulse height analyzer 514 can perform this analysis.
Referring now to FIGS. 10A to 10E, shown therein are various illustrations of an
exemplary embo iment of a ra iation sensor unit 550. The ra iation sensor unit
550 inclu es the scintillator flow cell 502 with the channels 518 an the fittin
gs 520. The ra iation sensor unit 550 also inclu es a light pipe 552 that has a
cylin rical bo y with a transverse concave surface en that complements the surf
ace curvature of the bo y of the scintillator flow cell 502 to make a tight fit
as well as to re uce the reflection of any light that is provi e by the scintil
lator flow cell 502. The other en 556 of the light pipe 552 is form fitte to a
ttach with the housing 560 of the photomultiplier tube 558. The photomultiplier
tube 588, which is commercially available, also inclu es connectors 562 an 564
as well as a voltage ivi er (see FIG. 10D). The ra iation sensor unit 550 also
inclu es an enclose housing 566, which acts as the shiel element 508 an also
keeps light out of the sensor unit 550 as well as inlet an outlet pipe sections
568 an 570 for the flui transport pipe 522 that protru e from the base of the
 enclose housing 566.
The specifications for the ra iation sensor unit 500 are to etect alpha, beta a
n gamma ra iation, inclu ing tritium, in flui samples. The ra iation sensor un
it 500 is sensitive to particle energies from less than 0.001 MeV to approximate
ly 8 MeV an generates at least 10 photons per keV of particle
energy absorbe . The ra iation sensor unit 500 also has a fast pulse response on
the or er of less than 50 ns an a ark count of less than 20 /s. The ra iation
sensor unit 500 also has a narrow energy resolution which is less than 10% FWHM
(Full-Wi th Half-Maximum). The ra iation sensor unit 500 is also non-hy roscopi
c (i.e. not water absorbent) an tolerates weak aci s an solvents.
It shoul be note that the ra iation sensor unit 500 can be evelope into a wh
ole bo y counter to monitor contamination by gamma emitting ra ionucli es eposi
te in the user's bo y. This can be one by irectly counting the eposite gamm
a emitting ra ionucli es in a ition to the internal soluble contamination, whic
h woul greatly expan the capabilities of the urinalysis apparatus 10.
Referring now to FIG. 11 , shown therein is a flow chart iagram illustrating an
exemplary embo iment of an operating metho 600 for operating the urinalysis ap
paratus 10. At step 602, the urinalysis apparatus 10 is operating in stan by mo
e an is waiting for a user to request a urinalysis test. At this point, the uri
nalysis apparatus has performe isinfect, cleanse an rain mo es an is rea y
to initiate a urine test. The user activates the urinalysis apparatus 10 through
the console 16. At step 604, the user provi es i entification information to th
e urinalysis apparatus, by inputting information via at least one of the keypa
20 or the isplay 18 if a touch screen is provi e , the car rea er 22 an the b
iometric scanner 24. The user is then typically provi e with the types of urina
lysis tests that can be performe by the urinalysis apparatus 10 an is aske to
make a selection. For instance, the user may be given the choice to select one
or more in ivi ual tests, or may select from pre- etermine groupings of tests.
Alternatively, once the user has i entifie himself, the selection of a test pro
tocol by the user may not be require if a physician or other me ical practition
er has provi e this information to the urinalysis apparatus 10. Once the type o
f urine testing is etermine , the urinalysis apparatus typically prompts the us
er for payment at step 606. The user then provi es the
appropriate payment, for instance, by using their cre it or ebit car with the
car rea er 22, or by epositing coins an /or banknotes into the money eposit m
echanism if this option is possible. The urinalysis apparatus 10 then processes
the payment. It shoul be note that there can be embo iments of the urinalysis
apparatus 10 in which payment is not require epen ing on the facility where th
e urinalysis apparatus is being use .
Once payment is processe , if it was require , the metho 600 moves to step 608
at which point the user is provi e with instructions on how to procee , namely
on how to provi e a urine sample (i.e. micturate into the inlet 14 for a certain
perio of time). The urine sample is receive by the inlet 14 an then provi e
to various components within the urinalysis apparatus 10 as previously escribe
an testing is performe at step 610. Once the testing is complete, the urinal
ysis apparatus 10 provi es test results at step 612. The test results are typica
lly provi e to the user by provi ing at least one of a printout by the printer
26 an a numerical or graphical presentation shown on the isplay 18. In some em
bo iments, the results are also transmitte to the user's physician, or another
intereste party, through by the communications mo ule 60 for recor keeping or
further analysis. It shoul be note that there may be some tests in which the u
ser is not irectly provi e with the test results, such as in testing for sport
s oping an the like. It shoul also be note that the various isinfect, clean
se an rain mo es as escribe in relation to FIG. 4 are performe as require
although not shown in FIG. 11.
In embo iments where the urinalysis apparatus 10 inclu es the biometric scanner
24, the user can initiate urinalysis testing by provi ing the require biometric
ata to the biometric scanner 24, for instance, by placing their finger on a fi
ngerprint scanner, or by positioning their eyes or face in line with an eye scan
ner or a facial scanner respectively such as the camera 74.
As previously mentione , there can also be embo iments in which the user oes no
t select the type of urinalysis tests to be con ucte since a me ical practition
er can etermine the type of urinalysis tests to con uct an interact remotely w
ith the communications mo ule 60 to provi e this information as
well as the user's biometric ata if it is not alrea y in the system. In this ca
se, while the user visits the me ical practitioner, the user can register their
biometric ata. The physician then associates the require urinalysis tests with
the user's biometric ata an provi es this information to the urinalysis appar
atus 10 via a remote server. In this case, the communications mo ule 60 establis
hes a secure communications link with the remote server (not shown) in or er to
retrieve the user's biometric ata along with information on the type of urinaly
sis tests to be con ucte as specifie by the me ical practitioner. The retrieve
biometric ata is then compare with the biometric ata obtaine by the biomet
ric scanner 24 in or er to i entify the user of the urinalysis apparatus 10, an
to etermine what types of urinalysis tests are to be performe for the user. I
n some embo iments, the results of the urinalysis tests are provi e to the user
an transmitte to the remote server over the secure communications link. The u
ser's physician can then access the remote server to retrieve the user's test re
sults for a itional analysis.
Alternatively, a user number can be associate with the biometric ata an use
by the me ical practitioner when sen ing the testing information to the urinalys
is apparatus 10. When the user interacts with the biometric scanner, the urinaly
sis apparatus 10 can compare this information with a atabase to obtain the corr
espon ing user number to access the test protocol that has been requeste by the
me ical practitioner.
The various embo iments of the urinalysis apparatus escribe herein provi e a s
elf monitoring system that allows the general population to check their health s
tatus, any time uring the ay or night, without requiring a visit to a health c
are professional. Accor ingly, the urinalysis apparatus lowers the cost of healt
h care an avoi s long-term wait for people nee ing to have a urine test. Base
on test results, the urinalysis apparatus can provi e the user with a warning of
a possible isease at a very early stage in or er to provi e the user with a be
tter chance of improving their health. The urinalysis apparatus is a fully autom
ate an autonomous iagnostic unit that is portable an capable of etecting va
rious chemicals an biomarkers.
With the urinalysis apparatus, the urine sample is provi e by one person at a t
ime, who are i entifie before testing, so there is no possibility of a mix-up o
f urine samples from ifferent people, which occurs from time to time using conv
entional urinalysis techniques. A flush, rinse an isinfect cycle automatically
prepares the urinalysis apparatus for the next urine test. Generally, the urina
lysis apparatus is cleane just before an just after the user provi es their ur
ine sample (straight into the machine). The analysis is also performe right aft
er the urine sample is provi e , an there is no nee for a lab technician to be
involve in interpreting the observe results, thereby removing the possibility
of intro ucing human error into the urine testing process. Accor ingly, the uri
nalysis apparatus provi es a very safe, straightforwar an hygienic sample coll
ector unit for in ivi uals to use at their ease.
The urinalysis apparatus allows for the collection an analysis of a urine sampl
e to occur almost concurrently. Accor ingly, sensors are provi e with the urine
sample very quickly which avoi s the issue of protein egra ation/ enaturation
that sometimes occurs with conventional urine testing ue to the transfer an st
orage of urine samples. The urinalysis apparatus is capable of provi ing multipl
e time-sensitive quantitative analyses an multiple qualitative biological/chemi
cal analyses of urine samples. For example, multiple immunoassays can be perform
e using SPR an ISE- base sensor units, as escribe previously. One of more o
ther types of sensors such as a flow rate sensor, a ra iation sensor, a colorime
ter an a temperature sensor can also be incorporate into the urinalysis appara
tus.
ISE sensors can etect the electrolyte concentration an ionic strength of vario
us elements such as, but not limite to potassium, nitrites, chlori e, so ium, p
otassium, calcium, ammonium, io i e, glucose an the like within the urine sampl
e. The pH, electrolytes an the specific gravity of the urine sample can also be
measure . The measurement of these various elements an properties can be one
by using certain ISE sensors that are built to etect them. These ISE sensors ar
e rea ily available in the marketplace an nee to be inserte into the sensor u
nit as escribe previously. Each
measure value is compare to a range of normative values for that measurement.
For example, the measure values of pH an specific gravity can be compare agai
nst the normative range of values of 4.5 to 8.0 for pH an 1.005 to 1.035 for sp
ecific gravity. The SPR sensors allow for the etection of pathogens an other b
iological organisms within the urine sample. The SPR sensors also allow for the
etection of bio-molecules responsible for the evelopment of certain iseases (
infectious, metabolic, etc.) an tumors in humans. Specifically, with the SPR se
nsors, many health-relate biomarkers inclu ing C-Reactive Protein (CRP), Prosta
te Specific Antigen (PSA), Human Immuno eficiency Virus (HIV), Human Chorionic G
ona otropin (HCG) an pathogens can be measure automatically in a single measur
ement. The SPR sensors also allow for the etection of viruses such as, but not
limite to, Smallpox, Ebola, Japanese B encephalitis, Marburg hemorrhagic fever,
Avian influenza an the like. The SPR sensors also allow for the etection of b
acteria such as, but not limite to, Bacillus anthracis, Francisella tularensis,
Clostri ium botulinum, Clostri ium perfringens, Coxiella burnetii an Yersinia
pestis as well as fungi such as, but not limite to, Cocci ioi es immitis an Hi
stoplasma capsulatum. The SPR sensors can also be use to etect pathogen marker
s, biological/chemical warfare agents, toxicants, herbici al constituents, prote
ins, ketones, certain nucleic aci s, pestici e measurements, rug iscovery, an
rug release. The etection of these various elements can be one by using an S
PR sensor that has been specially built to etect these elements. These SPR sens
ors are rea ily available in the marketplace an nee only be configure for use
with the SPR sensor unit escribe previously.
The scintillating sensors allow for the etection of ra ioactive constituents wi
thin the urine sample. This allows for the assessment of human exposure to ra ia
tion in various environments. Exposure of a person to common Beta an Gamma-emit
ting ra ionucli es such as tritium, ra io-carbon, ra io-sulfur, ra io-phosphate,
ra io-io ine, uranium an the like, lea s to a major
contamination of the whole biological system of the person which is reflecte in
their biological flui s (i.e. urine) in a short perio of time. The scintillati
on sensor unit can be use to etect such ra ionucli es in the person's urine an
to monitor the concentration of these ra ionucli es over time. The colorimetri
c sensors allow for the etection of color, opacity (i.e. clarity), proteins an
chemical constituents within the urine sample. The flow rate meter unit allows
for the measurement of flow rate an voi e volume as well as information with r
espect to any obstructions or problems with the urination process. Sensors can a
lso be use to measure osmolality, con uctivity. The colorimetric sensors as wel
l as the sensors that measure the osmolality an con uctivity can be inserte in
to the ISE sensor unit. Other sensors can also be evelope to etect re bloo
cell count an white bloo cell count from the urine sample.
Sensor units base on these ifferent types of sensor can be incorporate into t
he urinalysis apparatus in a mo ular fashion which allows the urinalysis apparat
us to be quite versatile an re-configurable epen ing on what tests shoul be p
erforme . This epen s on where an how the urinalysis apparatus is use . A urin
alysis apparatus having numerous ifferent types of sensors allows a user to per
form a variety of urine tests an receive a very etaile report on the urine sa
mple that they provi e. In a ition, a urinalysis apparatus with the sensors es
cribe above provi es improve early iagnosis of various iseases, such as earl
y etection of cancer an infectious isease, an this early etection can lea
to increase survival rates. The overall time require for urine sample analysis
is relatively short compare to conventional techniques an can last about 1-10
minutes. The test results for a variety of substances can be ma e available as
a printout, a screen isplay, an /or may be sent to a remote location that can b
e accesse by a me ical physician electronically, as soon as the analysis is com
plete. The urinalysis apparatus can provi e positive or negative test results fo
r the teste con itions/constituents by automatic comparison of measure values
of the urine sample with normative reference values or a range of normative refe
rence values.
The test results can also be a e to a atabase an abnormal in ications can be
flagge imme iately to all parties involve (i.e. the user, the user's octor,
etc.). Flexible atabase management an control ensures confi ential ata transp
ort an report routing. Test results can also be sent irectly to a me ical inst
itution, if appropriate, via a secure communications link such as, but not limit
e to, an SSL-secure interface. In a ition, the user oes not nee to wait for
the results after provi ing the urine sample. The user can get the test results
at a later time. For instance, the test results can be emaile to the user if t
he user provi es an email a ress along with their i entification information th
at was use to initiate urine testing. Alternatively, a website with a e icate
atabase can be employe along with the urinalysis apparatus to allow the user,
or another authorize person, to log on, from any computer via the Internet or
other network, an access their test results an etermine if further follow-up
testing is require .
Accor ingly, the urinalysis apparatus is capable of provi ing rea ily available,
real-time, time-sensitive qualitative an quantitative biological an chemical
analysis of the constituents in a urine samples along with uroflometric analysis
of the provision of the urine sample. Furthermore, epen ing on the particular
sensor configuration, the urinalysis apparatus escribe herein can automaticall
y an simultaneously measure a variety of ifferent parameters in a single urine
sample measurement an provi e an all-in-one functional iagnostic system for a
vance uro ynamics, electrolyte testing, rug trials, ra iological tests an ot
her uro- iagnostic parameters as is escribe below.
Urinalysis is also an excellent metabolic biofee back technique that can be use
to in icate whether a person's lifestyle is beneficial or etrimental. Urinalys
is also provi es specific information on which vitamins an minerals are not bei
ng assimilate into the user's cellular structure. In this regar , the urinalysi
s apparatus is useful as a general health monitoring system to etermine, for ex
ample, if a person is secreting too much or too little calcium
in their urine, which in icates whether there is an imbalance in the metabolism
of certain elements, which coul raise an important issue in the person's health
status. This can be one using the ISE sensors.
The urinalysis apparatus can also be use to watch the person's iet by i entify
ing the chemical levels excrete on a aily or other perio ic basis. In this reg
ar , the urinalysis apparatus can be use to keep the bo y in balance an harmon
y by provi ing routine urine testing for pH level an certain chemicals. The uri
nalysis apparatus can also facilitate 24-hour urine testing to measure the rate
at which a person's bo y is oing certain things, such as breaking own or resor
bing bone, for example, which is reflecte in the person's rate of calcium metab
olism. Accor ingly, the urinalysis apparatus can be use to etermine the person
's rate of calcium metabolism to pre ict the possibility of osteoporosis con iti
ons. The urinalysis apparatus also provi es an effective tool for assessing a pe
rson's ehy ration status. This can be one using the ISE sensors.
In a ition, the urinalysis apparatus can be use for testing nicotine consumpti
on in smokers since ifferent smokers may inhale ifferent levels of cigarette s
moke an the number of cigarettes smoke is not a reliable in icator of the actu
al nicotine consumption/contamination. The urinalysis apparatus can also be use
to provi e a urine alcohol an rug test. This can be one with a specialize s
ensor block.
Furthermore, it may be possible to provi e the urinalysis apparatus with more me
ical information so that a user can use the urinalysis apparatus to perform sel
f- iagnosis for a variety of me ical con itions. For instance, if the user suspe
cts that there is something wrong with their health then they can use the urinal
ysis apparatus to confirm their suspicions an etermine whether they require fu
rther me ical attention.
After every urine sample is analyze accor ing to a selecte test protocol, the
whole system is thoroughly econtaminate to prepare for reception an analysis
of the next urine sample. In a ition, the status of the urinalysis apparatus ca
n be continuously monitore an reporte through a secure
networking system so that any malfunctions that occur can be quickly etecte an
effectively ealt with. In this regar , the urinalysis apparatus has various s
ensors that provi e iagnostic information to the control mo ule 50 such as vari
ous overflow or power con itions. Accor ingly, the urinalysis apparatus is a sel
f-containe iagnostic evice with integrate analysis, communication systems an
self-cleaning mechanisms.
The fully automate nature of the urinalysis apparatus allows it to be eploye
in locations that are not serve by technical staff, such as lab technicians or
other me ical personnel, an requires no specialize human interaction to operat
e. Any lay person can operate the urinalysis apparatus. The urinalysis apparatus
instructs the user on an as-nee e basis until the test is complete an user is
cleare to leave.
Also, any consumable materials, such as printer paper, etergent, an the like t
hat are use by the urinalysis apparatus can be replace by non-technical person
nel when nee e . This allows the urinalysis apparatus to be eploye at a variet
y of locations such as, but not limite to, health spas, training facilities, MA
SH units, isaster areas, malls, sta iums, an other public places. The urinalys
is apparatus can also be use by the military as well as in police stations wher
e an in ivi ual's health status can be quickly an accurately screene for possi
ble infectious iseases an /or alcohol an rug abuse.
The urinalysis apparatus can also be eploye at airports where travelers can be
quickly an reliably screene for viruses an other pathogens that they may car
ry from other continents an /or countries. This helps in preventing major contag
ious health breakouts in a city or town as well as in protecting passengers on p
lanes from other passengers who may have a contagious health con ition.
The urinalysis apparatus can also be use in me ical facilities. For example, a
octor can have the urinalysis apparatus in his office so that he or she can tes
t a patient's urine sample an get the result almost in real-time to help with
iagnosis. This is especially useful in rural areas an isolate or inaccessible
villages, where there is limite access to a clinical iagnostic laboratory/faci
lity. The urinalysis apparatus can also be use in me ical centers, walk-in clin
ics, an rug stores as well as hospitals. In that regar , the urinalysis appara
tus can be use in emergency war s where a quick, accurate human testing system
is urgently nee e . The urinalysis apparatus is quite useful for clinics, which
nee to have a quick iagnostic tool especially when major outbreaks occur of a
new virus or bacteria, such as the SARS outbreak in 2003.
The urinalysis apparatus can also be use at bloo collecting centers, such as t
he Cana ian Bloo Services an Re Cross, where there is a nee to have a screen
ing system in place for bloo onors. With the urinalysis apparatus, urine testi
ng can occur on site before bloo collection to avoi collecting contaminate bl
oo .
The urinalysis apparatus can also be use in a university or research institute
laboratory facility for basic research or routine analyses purposes. For example
, the urinalysis apparatus can be use to effectively screen participants in cli
nical research stu ies who nee to be teste to assess whether they meet certain
inclusion/exclusion criteria to be accepte as an eligible participant in those
stu ies. It is very important for these participants to be teste every time th
ey return to the clinic an this apparatus will quickly provi e accurate informa
tion that can be use to etermine whether to inclu e the participant in further
stu ies.
The urinalysis apparatus also has a mo ular esign so that it can be configure
for a particular application or environment. For instance, the urinalysis appara
tus can be configure to match the nee s of the population being examine (e.g.
an airport might have a ifferent set of urine test requirements than a spa faci
lity). Accor ingly, the urinalysis apparatus can be configure for applications
in etecting sport oping, i.e. to facilitate testing at sporting event venues w
here rug testing is require such as the Olympics an the like. The urinalysis
apparatus can also be use to etect ra iation exposure, munitions exposure, pat
hogens an PSA cancer. The urinalysis
apparatus can also be use to provi e a simple an quick tool for serving human
rights especially for immigrants, while they are waiting for their health care p
lan to be approve an issue .
Since the urinalysis apparatus is portable, it is also useful for provi ing quic
k, accurate iagnostic services for remote areas especially in times of major ev
ents such as earthquakes, hurricanes, floo s an other environmental isastrous
situations. The urinalysis apparatus can also be use in areas where there are m
ilitary conflicts, or where there is potential for outbreaks or pathogenic trans
fer among the population. The urinalysis apparatus can also be use in thir wor
l countries where nutritional iagnostics an examination of foo -ai istribut
ion/content is important. In these applications, the urinalysis apparatus can be
use to monitor the effect of foo an the environment on a person by analyzing
their urine.
It shoul also be note that the urinalysis apparatus is not restricte solely t
o the analysis of urine. This apparatus can also be use for analyzing the chemi
cal makeup of a variety of water-base liqui s by reconfiguring the sensors an
normative ata that are use . For instance, this apparatus can also be use in v
arious environmental epartments to analyze water or other flui s. The apparatus
can also be use for water supply analysis for emergency shelters, temporary ve
nues, isaster relief, pools, beaches an reservoirs. In these ifferent applica
tions, flui samples can be irectly poure into the inlet of the urinalysis ev
ice or the inlet can be remove an a pipe from the water supply can be connecte
to the urinalysis evice with appropriate valves for perio ic or constant moni
toring. It shoul be note that the term "con uit" is meant to cover the term "p
ipe" as a pipe is a form of a con uit. Accor ingly, various components of the ur
inalysis apparatus 10 can be escribe as con uits. For instance, the terms pipe
assembly, pipe section, piping components, piping mechanism can be replace wit
h the terms con uit assembly, con uit section, con uit components, an con uit m
echanism respectively.
It shoul also be note that in at least one inventive embo iment escribe here
in, a urinalysis apparatus is escribe comprising a housing; an inlet ispose
along a portion of the housing an configure to receive a urine sample from a u
ser; at least one sensor unit ispose within the housing an having at least on
e sensor configure to measure at least one parameter from at least a portion of
the urine sample; a urine transport assembly ispose within the housing an co
nfigure to transport the urine sample from the inlet to the at least one sensor
unit uring a measurement mo e; a cleansing flui transport assembly ispose w
ith the housing an configure to ispose of the urine sample after the measurem
ent mo e an cleanse the apparatus uring a cleanse mo e; an a control mo ule c
onfigure to control the urinalysis apparatus in an automate fashion an eterm
ine at least one user characteristic from the at least one measure parameter.
The urine transport assembly comprises a first plurality of con uits ispose be
tween the inlet an the at least one sensor unit an configure to transport the
urine sample from the inlet to the at least one sensor unit; an at least one e
lectronic valve configure to gate the flow of the urine sample within the urine
transport assembly in response to gating comman s receive from the control mo
ule. The urinalysis apparatus inclu es a cleansing flui transport assembly that
comprises a secon plurality of con uits couple to the inlet, the urine transp
ort assembly an the at least one sensor unit; at least one other electronic val
ve for gating the flow of cleansing flui through portions of the apparatus in r
esponse to gating comman s receive from the control mo ule; at least one flui
pump for pumping cleansing flui through the first an secon plurality of con u
its in response to pumping comman s receive from the control mo ule; an a clea
nsing flui tank configure to provi e the cleansing flui in use.
The urinalysis apparatus can further comprise a calibration unit couple to the
urine transport assembly an configure to provi e a calibration flui through
the urine transport assembly to the at least one sensor unit to calibrate the at
least one sensor.
The at least one sensor can be configure to measure at least one parameter of t
he calibration flui , an the control mo ule is configure to use the at least o
ne measure parameter of the calibration flui as a baseline measurement to cali
brate the at least one sensor.
The urinalysis apparatus can be in a housing which is a kiosk.
The urinalysis apparatus further comprises a isplay ispose on a portion of th
e housing to provi e information to the user. The control mo ule of the urinalys
is apparatus is further configure to report the at least one user characteristi
c.
The urinalysis apparatus further comprises a user interface configure to receiv
e input from the user.
In some cases, the isplay an a portion of the user interface are provi e by a
 touch screen isplay.
The urinalysis apparatus can further comprise a communication mo ule configure
to transmit an receive user ata from a remote system.
The urinalysis apparatus can further comprise a printer configure to provi e a
printout of information about the urine sample. The urinalysis apparatus can fur
ther comprise a biometric scanner configure to measure a biometric parameter of
the user to i entify the user.
The biometric parameter of the user can be communicate by the communication mo
ule to the remote system to i entify the user, an to etermine which user chara
cteristic is to be analyze by the urinalysis apparatus.
The urinalysis apparatus further comprises a payment unit configure to accept p
ayment from the user to commence urine testing.
The urinalysis apparatus can further comprise a flow meter unit that is couple
between the inlet an the urine transport assembly, the flow meter unit being co
nfigure to measure a flow rate of the urine sample into the inlet uring mictur
ition an to measure a uration of micturition. The control mo ule can be config
ure to receive the measure flow rate an uration of micturition an etermine
therefrom an amount for the urine sample available for measurement.
The at least one sensor unit can comprise a plurality of ion selective electro e
sensors; an a bo y for housing the plurality of sensors, the bo y being couple
with the urine transport assembly an being configure to efine a channel the
rethrough an a plurality of sensor ports, each sensor port having an outer port
ion at a surface of the bo y for receiving one of the plurality of ion selective
electro e sensors an an inner portion terminating at the channel to position s
ensing en s of the plurality of ion selective electro e sensors within the chann
el, wherein, uring use, the channel receives a portion of the urine sample uri
ng the measurement mo e an a portion of the cleansing flui uring the cleanse
mo e, an wherein sensing en s of the plurality of ion selective electro e senso
rs are immerse within the portion of the urine sample uring the measurement mo
e an within the portion of the cleansing flui uring the cleanse mo e.
In at least some cases, the urinalysis apparatus can comprise at least two senso
r units having ifferent types of sensors. The ifferent types of sensors compri
se at least two of an ion selective electro e sensor, a surface plasmon resonanc
e sensor, an a scintillation sensor. The urinalysis apparatus can also comprise
an inlet that inclu es a funnel having an outlet port at a lower portion thereo
f couple to a portion of the urine transport assembly, wherein a lower portion
of the funnel an the portion of the urine transport assembly have a slope selec
te to transport the urine sample primarily using gravitational force to minimiz
e interference with flow characteristics of the urine sample uring the measurem
ent mo e.
The funnel further comprises a flushing flui inlet port couple to a portion of
the cleansing flui transport assembly to receive a pressurize portion of the
cleansing flui uring the cleanse mo e.
In a ition, in at least one inventive embo iment escribe herein a metho is
escribe for performing urinalysis. The metho comprises: receiving a urine samp
le from a user; provi ing at least a portion of the urine sample via a urine tra
nsport assembly to at least one sensor unit; measuring at least one parameter fr
om the at least a portion of the urine sample uring a measurement mo e; isposi
ng the urine sample after the measurement mo e; cleansing the apparatus uring a
cleanse mo e; an provi ing test results on at least one user characteristic ba
se on the at least one measure parameter. The metho can further comprise prov
i ing a calibration flui through the urine transport assembly to the at least o
ne sensor unit to calibrate the at least one sensor unit.
The metho can further comprise obtaining a biometric parameter of the user to i
entify the user an to etermine which user characteristic is to be analyze by
the urinalysis apparatus.
The user provi es the urine sample uring micturition an the metho can further
comprise measuring uroflowmetric properties of the user uring micturition.
The metho further can comprises using at least two of an ion selective electro
e sensor, a surface plasmon resonance sensor, an a scintillation sensor uring
urinalysis.
In a ition, in at least one inventive embo iment escribe herein a flow meter
unit is escribe for measuring a flow rate of a flui stream. The flow
meter unit comprises an intake bucket having an inlet a apte to receive the flu
i stream an an outlet a apte to release the measure flui stream; a rotating
element ispose within the intake bucket, the rotating element having a plural
ity of angle surfaces; an actuator configure to rotate the rotating element at
a nominal rotation rate; a sensor unit configure to sense the rotation of the
rotating element; an control circuitry configure to sense eviations in the ro
tation of the rotating element from the nominal rotation rate in or er to calcul
ate the flow rate of the flui stream an control the actuator to rotate the rot
ating element at the nominal rotation rate, wherein, in use, eviations from the
nominal rotation rate are ue to the flui stream contacting the rotating eleme
nt.
The flow meter can comprise a rotating element that inclu es a multi-bla e impel
ler having bla es ra iating from a rotation axis of the multi-bla e impeller an
being angle with respect to a plane of the inlet of an intake bucket. The flow
meter can comprise an actuator that comprises a motor an the sensor unit compr
ises a sensor configure to sense the instantaneous rotation rate of the rotatin
g element, an the ifference between the instantaneous rotation rate an the no
minal rotation rate is proportional to the flow rate of the flui stream. The co
ntrol circuitry can comprise a phase locke loop.
The intake bucket can be an enclose structure a apte to efine the inlet an t
he outlet an otherwise being seale to prevent leakage un er a variety of flow
rates for the flui stream.
The inlet can comprise a tube having a longitu inal axis with a slope selecte t
o allow the flui stream to move through the tube primarily un er the force of g
ravity.
In a ition, in at least one inventive embo iment escribe herein, a metho of
measuring a flow rate of a flui stream is escribe . The metho comprises:
rotating a rotating element having a plurality of angle surfaces at a nominal r
otation rate; irecting the flui stream onto the angle surfaces of the rotatin
g element; sensing the rotation of the rotating element; an calculating the flo
w rate of the flui stream base on eviations in the rotation of the rotating e
lement from the nominal rotation rate.
The metho can comprise using a multi-bla e impeller as the rotating element, th
e rotating element having angle bla es ra iating from a rotation axis of the mu
lti-bla e impeller.
The metho can comprise using a tube having a longitu inal axis with a slope sel
ecte to provi e the flui stream to the rotating element primarily un er the fo
rce of gravity. The calculating step can comprise using a phase locke loop.
In at least one inventive embo iment escribe herein, an inlet mo ule is escri
be that is a apte to receive a urine sample from a micturating user. The inlet
mo ule comprises a funnel configure to receive the urine sample from the user
uring use; an an outlet port ispose along a first portion of the funnel an
configure to provi e the urine sample to a ownstream evice uring use.
The outlet port is at a lower portion of the funnel, an the lower portion of th
e funnel an a plane of the outlet port have a slope selecte to transport the u
rine sample to a ownstream element using gravitational force to minimize interf
erence with flow characteristics of the urine sample uring use.
The inlet mo ule further comprises an inlet port ispose along a secon portion
of the funnel an configure to receive a cleansing flui uring use; an a cle
ansing flui istribution element ispose along an upper portion of the funnel
an a apte to provi e a circumferential stream of the cleansing
flui an a plurality of jets of the cleansing flui when receiving the cleansin
g flui from the inlet port uring use.
The inlet port is efine at an upper portion of the funnel.
The cleansing flui istribution element comprises an inwar ly an ownwar ly ex
ten ing lip at an upper portion of the funnel to efine a channel circumscribing
the upper portion of the funnel, an the ownwar ly exten ing portion of the li
p has a plurality of holes.
The inlet port opposes an inner wall of the lip, wherein uring use, the cleansi
ng flui is irecte against the inner wall of the flui istribution element wh
ere a portion of the cleansing flui follows the channel to form the circumferen
tial stream an another portion of the cleansing flui passes through the plural
ity of holes to form the plurality of jets.
The plurality of holes can exten along the circumference of the lip.
In yet another exemplary inventive embo iment escribe herein a ra iation senso
r unit is escribe that is configure to etect ra ioactive components in a flu
i sample. The ra iation sensor unit comprises a scintillator flow cell configur
e to receive the flui sample an pro uce a photon light signal in proportion t
o the ra ioactive components inclu e in the flui sample; a photoelectric conve
rsion mo ule configure to convert the photon light signal into a photoelectric
signal an amplify the photoelectric signal; an electrical circuitry configure
to further amplify the photoelectric signal to pro uce a pre- processe electri
cal signal.
The ra iation sensor unit can further comprise an analyzer configure to analyze
the pre-processe signal to etermine concentration an type of the ra ioactive
components in the flui sample.
The photoelectric conversion mo ule comprises a light con uit configure to tran
sport the photon light signal; a photomultiplier configure to convert the trans
porte photon light signal into the photoelectric signal an amplify the photoel
ectric signal; an a shiel element a apte to surroun the
photomultiplier, the light con uit an the scintillation flow cell to provi e el
ectromagnetic shiel ing.
The electrical circuitry can comprise a charge amplifier an a Gaussian shaping
amplifier. The scintillation flow cell comprises a plurality of channels an a f
lui transport con uit place within the channels to form several loops through
the scintillation flow cell to transport the flui sample through the scintillat
ion flow cell several times.
The scintillation flow cell can be a ro an an en of the light con uit a jacen
t to the scintillation flow cell has a concave shape to mate with the outer surf
ace of the scintillation flow cell.
The ra iation sensor unit further comprises a housing to block light from the sc
intillation flow cell an the photoelectric conversion mo ule an provi e shiel
ing from external magnetic fiel s. In yet another inventive embo iment escribe
herein a metho of etecting ra ioactive components in a flui sample is escri
be . The metho comprises: transporting the flui sample through a scintillation
flow cell which pro uces a photon light signal in proportion to the ra ioactive
components inclu e in the flui sample; converting the photon light signal int
o a photoelectric signal; amplifying the photoelectric signal to pro uce a pre-
processe electrical signal; an analyzing the pre-processe signal to etermine
concentration an type of the ra ioactive components in the flui sample.
The analyzing step can comprise creating a histogram of pulse heights versus fre
quency of the pulse heights.
The converting step comprises transporting the photon light signal via a light c
on uit to a photomultiplier that converts the transporte photon light signal in
to the photoelectric signal an amplifies the photoelectric signal.
The metho further comprises shiel ing the photomultiplier, the light con uit an
the scintillation flow cell from external electromagnetic signals an external
light.
The transporting step comprises passing the flui sample through the scintillati
on flow cell several times by passing the flui sample through a plurality of ch
annels in the scintillation flow cell in a serial fashion. In yet another invent
ive embo iment escribe herein, a surface plasmon resonance etection unit is
escribe that is configure to etect components of interest in a flui sample.
The etection unit comprises a surface plasmon resonance sensor; a flow cell abu
tting a sensing surface of the surface plasmon resonance sensor an a apte to c
hannel the flui sample over the sensing surface in an automate fashion; an an
imaging system couple to the Surface Plasmon Resonance (SPR) sensor an config
ure to measure changes on the sensing surface ue to interactions with componen
ts in the channele flui sample.
The etection unit further comprises a flui transport assembly couple to the f
low cell, the flui transport assembly comprising: a flui elivery assembly a a
pte to transport the flui sample to the flow cell; an a flui expulsion assem
bly a apte to transport the flui sample from the flow cell after measurement.
The flui transport assembly further comprises a cleansing flui source couple
to the flui elivery assembly an the flui expulsion assembly, the cleansing f
lui source being a apte to supply a cleansing flui to expel the flui sample
after measurement an flush the flui elivery assembly, the flow cell, an the
flui expulsion assembly.
The flui transport assembly further comprises a regeneration flui source coupl
e to the flui elivery assembly an a apte to supply a regeneration
flui to the sensing surface of the SPR sensor to regenerate the sensing surface
after flui sample measurement.
The flui transport assembly can further comprises a calibration flui source co
uple to the flui elivery assembly an a apte to supply a calibration flui t
o the sensing surface of the SPR sensor to calibrate the SPR sensor.
The flui elivery assembly comprises an inlet con uit couple to the flow cell
an a apte to gui e the flui sample to the flow cell.
The flui expulsion assembly comprises an outlet con uit couple to the flow cel
l an a apte to remove the flui sample from the flow cell after measurement.
The flui transport assembly comprises at least one flui pump a apte to rive
the flui sample, the cleansing flui , an the regeneration flui through the in
let con uit, the flow cell, an the outlet con uit.
In another implementation, the etection unit comprises: a flui transport assem
bly couple to the flow cell an a apte to transport the flui sample to an fr
om the flow cell; a cleansing flui source couple to the flui transport assemb
ly an a apte to supply a cleansing flui to expel the flui sample after measu
rement an flush the flow cell an the flui transport assembly; a regeneration
flui source couple to the flui transport assembly an a apte to supply a reg
eneration flui to the sensing surface of the flow cell to regenerate the sensin
g surface after measurement; an a calibration flui source couple to the flui
elivery assembly an a apte to supply a calibration flui to the sensing surf
ace of the SPR sensor to calibration the SPR sensor. The surface plasmon resonan
ce sensor can be a apte to etect at least one of a c-reactive protein, a prost
ate specific antigen, a human immuno eficiency virus, an a human chorionic gona
rotropin in the channele flui sample.
The etection unit can further comprise an SPR sensor replacement mechanism an
replacement SPR sensors, wherein the SPR sensor
replacement mechanism is configure to automatically replace a current SPR senso
r with one of the replacement SPR sensors.
The etection unit can further be configure to perform calibration on the curre
nt SPR sensor to etermine whether the current SPR sensor shoul be replace wit
h the one of the replacement SPR sensors.
The sensing surface can comprise a microarray of etection elements an each et
ection element is configure to etect a molecule of interest in the flui sampl
e.
Alternatively, the sensing surface can comprise a plurality of channels, each of
the channels comprising a microarray of etection elements an each etection e
lement is configure to etect a molecule of interest in the flui sample.
In yet another inventive embo iment escribe herein, a metho of etecting comp
onents of interest in a flui sample is escribe . The metho comprises: channel
ing the flui sample over a sensing surface of a
Surface Plasmon Resonance (SPR) sensor in an automate fashion; an imaging the
sensing surface to measure changes on the sensing surface ue to interactions wi
th components in the channele flui sample. The metho further comprises transp
orting the channele flui sample away from the sensing surface after measuremen
t, an flushing the sensing surface with a cleansing flui in an automate fashi
on.
The metho further comprises supplying a regeneration flui to the sensing surfa
ce of the SPR sensor in an automate fashion to regenerate the sensing surface a
fter flui sample measurement.
The metho can further comprise supplying a calibration flui to the sensing sur
face of the SPR sensor in an automate fashion to calibrate the SPR sensor.
The metho can comprise configuring the sensing surface of the SPR sensor to et
ect at least one of a c-reactive protein, a prostate specific antigen, a human i
mmuno eficiency virus, an a human chorionic gona rotropin in the channele flui
sample. The metho can further comprise etermining whether the SPR sensor nee
s to be replace an automatically replacing the SPR sensor with a replacement
SPR sensor when the SPR sensor requires replacement.
The metho can further comprise provi ing the sensing surface with a microarray
of etection elements that are each configure to etect a molecule of interest
in the flui sample.
Alternatively, the metho can comprise provi ing the sensing surface with a plur
ality of channels that each comprise a microarray of etection elements an each
etection element is configure to etect a molecule of interest in the flui s
ample. In any of the embo iments escribe herein, the flui sample can be urine
.
While the applicant's teachings are escribe herein in conjunction with various
embo iments, it is not inten e that the applicant's teachings be limite to su
ch embo iments. On the contrary, the applicant's teachings encompass various alt
ernatives, mo ifications an equivalents, as will be appreciate by those of ski
ll in the art, the general scope of which is efine in the appen e claims.