wipo wo 2009094761 20090806 received march 29 2009 farsad kiani edouard kisenko saulius brikis elias...

8/9/2019 Wipo Wo 2009094761 20090806 Received March 29 2009 Farsad Kiani Edouard Kisenko Saulius Brikis Elias Koikas

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WO 2009094761 20090806TITLE: APPARATUS AND METHOD FOR URINALYSIS

Latest bibliographic data on file with the International Bureau

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Bookmark this pagePub. No.: WO/2009/094761 International Application No.:

PCT/CA2009/000089Publication Date: 06.08.2009 International Filing Date: 23.01.2009IPC: 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)Applicants: EXCELTION MEDICAL INNOVATIONS INC. [CA/CA]; Suite 14 205 TorbayRoad 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 20090806TITLE: 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 language: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 (incompliance with PCT Rule 17.1)


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(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) (for 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) (forUS only)SONG, Fayi [CN/CA]; 1 Beethoven Court North York , Ontario M2H 1W1 (CA) (for USonly)KISENKO, Eduard Yuriyouy [CA/CA]; 64 Raintree Crescent Richmond Hill , Ontario L4E 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) (for US only)XIONG, Hui [CN/CA]; 1 Beethoven Court North York , Ontario M2H 1W1 (CA) (for USonly)

(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 PROCD D'ANALYSE D'URINE

(57) Abstract:(EN): A urinalysis apparatus operates in an automated fashion to determine at least one user characteristic from at least one measured parameter of a urine sample that is provided directly by a user. The urinalysis apparatus includes an inlet for receiving the urine sample and at least one sensor unit having at least one sensor configured to measure at least one parameter from at least a portion of the urine sample. The urinalysis aparatus also has a urine transport assemblyfor transporting the urine sample from the inlet to a sensor unit during a measurement mode, and a cleansing fluid transport assembly for disposing of the urinesample after the measurement mode and cleansing the apparatus during a cleansemode. The urinalysis apparatus can also include other sensor units and a flow meter unit.

(FR): L'invention porte sur un appareil d'analyse d'urine qui fonctionne en modeautomatis et permet de mesurer au moins une caractristique utilisateur part

ir d'au moins un paramtre mesur d'un chantillon d'urine directement fourni par l'utilisateur. L'appareil d'analyse d'urine selon l'invention comprend une entre destine recevoir l'chantillon d'urine et au moins une unit capteur comp


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renant au moins un capteur configur pour mesurer au moins un paramtre partird'au moins une partie de l'chantillon d'urine. L'appareil d'analyse d'urine prcit comprend aussi un ensemble de transport d'urine destin transporter l'chantillon d'urine depuis l'entre jusqu' une unit capteur dans un mode de mesure, et un ensemble de transport de liquide de nettoyage destin vacuer l'chantillon d'urine aprs le mode de mesure et nettoyer l'appareil dans un mode denettoyage. L'appareil d'analyse d'urine peut galement comprendre d'autres unit

s capteurs et une unit dbitmtre.

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, ZWEuropean Patent Office (EPO) : AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, TRAfrican Intellectual Property Organization (OAPI) : BF, BJ, CF, CG, CI, CM, GA,GN, GQ, GW, ML, MR, NE, SN, TD, TGAfrican Regional Intellectual Property Organization (ARIPO) : BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZWEurasian Patent Organization (EAPO) : AM, AZ, BY, KG, KZ, MD, RU, TJ, TM

FIELD

The embodiments described herein relate to an apparatus and method for urinalysis.


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BACKGROUND

Urinalysis, which is the analysis of a urine sample, is a common medical test that can reveal important health related information about the person or animal that provided the urine sample. A urine sample can be analyzed to determine whether 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 analyzedto determine whether a person has consumed illegal or banned substances. A urine sample can also be analyzed to detect the presence of biomolecules that indicate whether a person has developed cancer, or has any of a number of infectious diseases. A urine sample is also commonly analyzed to determine whether a woman is pregnant.

A person whose urine is to be analyzed typically provides one or more urine samples to a physician or other medical professional. The urine samples are sent, sometimes through a courier service, to a medical laboratory for analysis. Trainedmedical laboratory technologists or physicians at the medical laboratory then conduct 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 batches, with several urine samples from different people being analyzed together.

A number of problems arise with this process. First, the costs of operating medical laboratories are generally borne by the health care system (public or private). As a result, urinalysis tests may not be as accessible by people who would like to get tested to determine the state of their health without having to visita physician. Second, the time delays involved may inconvenience both physiciansas well as the people whose urine is being analyzed. In some

instances, the time delays can lead to undesirable consequences resulting from delayed 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 delivery, thereby reducing the accuracy and reliability of the analysis.

SUMMARY

In a first aspect of the invention, at least one exemplary embodiment describedherein provides a urinalysis apparatus comprising a housing; an inlet disposed along a portion of the housing and configured to receive a urine sample from a user; at least one sensor unit disposed within the housing and having at least onesensor configured to measure at least one parameter from at least a portion ofthe urine sample; a urine transport assembly disposed within the housing and configured to transport the urine sample from the inlet to the at least one sensorunit during a measurement mode; a cleansing fluid transport assembly disposed with the housing and configured to dispose of the urine sample after the measurement mode and cleanse the apparatus during a cleanse mode; and a control module configured to control the urinalysis apparatus in an automated fashion and determine at least one user characteristic from the at least one measured parameter.

In another aspect of the invention, at least one exemplary embodiment describedherein provides a method for performing urinalysis. The method comprises: receiving a urine sample from a user; providing at least a portion of the urine samplevia a urine transport assembly to at least one sensor unit; measuring at leastone parameter from the at least a portion of the urine sample during a measurement mode; disposing the urine sample after the measurement mode;

cleansing the apparatus during a cleanse mode; and providing test results on atleast one user characteristic based on the at least one measured parameter.


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In yet another aspect of the invention, at least one exemplary embodiment described herein provides a flow meter unit for measuring a flow rate of a fluid stream. The flow meter unit comprises an intake bucket having an inlet adapted to receive the fluid stream and an outlet adapted to release the measured fluid stream; a rotating element disposed within the intake bucket, the rotating element having a plurality of angled surfaces; an actuator configured to rotate the rotating 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 deviations in the rotation of the rotating element from the nominal rotation rate in order to calculate the flow rate of the fluid stream and control the actuator to rotate the rotating element at the nominal rotation rate, wherein, in use, deviations from the nominal rotation rate are due to the fluid stream contacting the rotating element.

In yet another aspect of the invention, at least one exemplary embodiment described herein provides a method of measuring a flow rate of a fluid stream. The method comprises: rotating a rotating element having a plurality of angled surfacesat a nominal rotation rate; directing the fluid stream onto the angled surfacesof 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 ofthe rotating element from the nominal rotation rate.

In yet another aspect of the invention, at least one exemplary embodiment described herein provides an inlet module adapted to receive a urine sample

from a micturating user. The inlet module comprises a funnel configured to receive the urine sample from the user during use; and an outlet port disposed alonga first portion of the funnel and configured to provide the urine sample to a downstream device during use. In yet another aspect of the invention, at least oneexemplary embodiment described herein provides a radiation sensor unit configured to detect radioactive components in a fluid sample. The radiation sensor unitcomprises a scintillator flow cell configured to receive the fluid sample and p

roduce a photon light signal in proportion to the radioactive components included in the fluid sample; a photoelectric conversion module configured to convert the photon light signal into a photoelectric signal and amplify the photoelectricsignal; and electrical circuitry configured to further amplify the photoelectric signal to produce a pre-processed electrical signal.

In yet another aspect of the invention, at least one exemplary embodiment described herein provides a method of detecting radioactive components in a fluid sample. The method comprises: transporting the fluid sample through a scintillationflow cell which produces a photon light signal in proportion to the radioactivecomponents included in the fluid sample; converting the photon light signal intoa photoelectric signal; amplifying the photoelectric signal to produce a pre- processed electrical signal; and analyzing the pre-processed signal to determineconcentration and type of the radioactive components in the fluid sample.

In yet another aspect of the invention, at least one exemplary embodiment described herein provides a surface plasmon resonance detection unit configured to detect components of interest in a fluid sample. The detection unit comprises a surface plasmon resonance sensor; a flow cell abutting a sensing surface of the surface plasmon resonance sensor and adapted to

channel the fluid sample over the sensing surface in an automated fashion; and an imaging system coupled to the Surface Plasmon Resonance (SPR) sensor and configured to measure changes on the sensing surface due to interactions with components 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 components of interest in a fluid sample. The method comprises: channeling the fluid sample over a sensing surface of a Surface Plasmon Resonance (SPR) sensor in a


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n automated fashion; and imaging the sensing surface to measure changes on the sensing surface due to interactions with components in the channeled fluid sample.

Further aspects and features of the exemplary embodiments described herein willappear from the following description taken together with the accompanying drawings.

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 effect, 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 apparatus that is portable;

FIG. 2 is a schematic diagram illustrating various components of the urinalysisapparatus of FIG. 1 ;

FIG. 3 is a schematic diagram illustrating an exemplary embodiment of various piping components of the urinalysis apparatus of FIG.

1;

FIG. 4 is a flow chart diagram illustrating an exemplary embodiment of a flow sequencing method for the urinalysis apparatus;

FIG. 5A is a perspective view of an exemplary embodiment of an inlet of the urinalysis apparatus of FIG. 1 ; FIG. 5B is a cross-sectional view along line B-B ofthe 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 flow meter unit for measuring the flow rate of a fluid stream; FIG. 6B is a perspective 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 unitof FIG. 6B;

FIG. 6D is a schematic circuit diagram of an exemplary circuit module of the flow meter unit of FIG. 6A;

FIG. 7A is a perspective view of an exemplary embodiment of a housing for a sensor 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 the 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 the sensor body;


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FIG. 8 is a schematic diagram of an exemplary embodiment of a Surface Plasma Resonance (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 scintillation 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 scintillatorflow 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 scintillation 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 method for operating the urinalysis apparatus of FIG. 1.

The person skilled in the art will understand that the drawings, are for illustration purposes only and that they are not intended to limit the scope of the applicant's teachings in any way.

DETAILED DESCRIPTIONIt will be appreciated that for simplicity and clarity of illustration, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. In addition, numerous specific details are set forth in order to provide a thorough understanding of the inventive embodiments described herein. However, it will be understood by those of ordinaryskill in the art that the embodiments described herein may be practiced withoutthese specific details. In other instances, well-known methods, procedures andcomponents have not been described in detail so as not to obscure the inventiveembodiments described herein. Also, the description of the various examples provided herein is meant to further an understanding of various aspects of the applicant'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 embodiment.

Referring first to FIG. 1 , shown therein is a perspective view of an exemplaryembodiment of a urinalysis apparatus 10 that is portable. The urinalysis apparatus 10 comprises a housing 12 in the form of a kiosk that houses various components of the urinalysis apparatus 10. The housing 12 has an inlet 14 for receivinga urine sample from the user while the user micturates (i.e. urinates). The urine sample is received by the inlet 14 and provided to various components within the urinalysis apparatus 10 that analyze the urine sample. The front panel of thehousing 12 includes a number of components that allow the user to interact withthe urinalysis apparatus 10. The urinalysis apparatus 10 further includes a console 16, also known as a user interface, formed of a display 18, a keypad 20, acard reader 22, a biometric scanner 24 and a printer 26. The urinalysis apparatus 10 also includes a plurality of ventilation vents 28 and a plurality of casterwheels 30. The placement of some of these elements can be varied in alternativeembodiments. Some of these elements are optional in some cases.

The console 16 allows the user to use the urinalysis apparatus 10 to perform a urine test and to receive a report of the results of the urinalysis. The display18 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 information. The display 18 can be a cathode-ray tube display, a plasma display, an LCDdisplay or any other suitable display mechanism. The keypad 20 is a keyboard, a


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touchpad, or some combination thereof. In alternative embodiments, the display18 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 keypad 20 can include a trackball or can be replaced by a trackball. The biometricscanner 24, which is optional, can be used to collect biometric data that can be used to measure a biometric parameter of the user to identify

the user. The measured biometric parameter can be communicated by a communication module (see FIG. 2) to a remote system (not shown) to identify the user and access related personal and/or test information. The measured biometric parametercan also be used to determine which user characteristic is to be analyzed by theurinalysis apparatus 10. In this exemplary embodiment, the biometric scanner 24is a fingerprint reader. However, in alternative embodiments, the biometric scanner 24 can be an eye scanner, a facial scanner and the like. Alternatively, theuser can use the card reader 22 along with a public or private health insurancecard, or other identification card such as a driver's license, to identify themselves.

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 commence the urine test. In this embodiment, the payment unit includes the card reader 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 urinalysis apparatus 10. In some embodiments, the payment unit also includes a money deposit mechanism (not shown) that accepts coins and/or banknotes to provide the user with a number of ways to provide payment for using the urinalysis apparatus 10. It should be noted that there can be alternative embodiments in which payment is not required to conduct a urine test.

After the test is completed, the display 18 can provide test results and other information to the user. The printer 26 can also provide the user with the results 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 as a receipt for payment received from the user for using the urinalysis apparatus 10 as well as further information or instructions to take further steps depending on the type of test conducted and the test results. For example, for positive test results of a serious condition, further information can be provided to the user with regard to taking appropriate medical action. The test

information can also be communicated to a remote location as explained in further detail below.

The housing 12 may be made from stainless steel panels, or other appropriate materials well known to those of skill in the art. The ventilation vents 28 are distributed along the upper and lower portions of the side and back panels of the housing 12 to provide a heat pathway through which heat generated by the internalcomponents of the urinalysis apparatus 10 can be ventilated in order to keep the components at a safe operating temperature. In some embodiments, ventilation fans (not shown) are used within the housing 12 to enhance heat transfer to the exterior of the housing 12. The caster wheels 30 are coupled to the base of the housing 12 to allow the urinalysis apparatus 10 to be easily transported. The caster wheels 30 typically include a locking mechanism to prevent the urinalysis device 10 from inadvertently moving while in use. Referring now to FIG. 2, shown therein are various components of the urinalysis apparatus 10 according to an exemplary embodiment. The urinalysis apparatus 10 generally includes a control module 50, a flow meter unit 52, a sensor unit 54, a cleansing fluid transport assembly 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 transport assembly 56 is shown in FIG. 2. A more detailed view of the cleansing fluid transport assembly 56 is shown in FIG. 3. Also, it should be noted that the


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urinalysis apparatus 10 also includes a urine transport assembly, portions of which are shown in FIG 2. The urine transport assembly is shown more clearly in FIG. 3. The urinalysis apparatus 10 further includes a USB hub 62, an Input/Output (I/O) module 64, a power supply control panel 66, a power supply unit 68 and auxiliary 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 implemented by any suitable micro-processor or controller as is commonly known bythose skilled in the art. The control module 50 also

includes memory components and the like. The memory components can be used to maintain information on studies that can be conducted based on all of the urine tests that are performed. The control module can be implemented with an off-the-shelf processor, such as a 3 GHz processor, with a suitable amount of RAM on the order of 1 GB. The control module 50 can control various components such as the flow meter unit 52, the urine and cleansing fluid transport mechanisms, and the sensor unit 54. For instance, the control module 50 controls the on and off stateof various electronic values thereby allowing or disallowing fluid flow through

various sections of the urinalysis apparatus 10. The control module 50 also controls various pumps to flush various fluids, such as cleansing fluids and calibration fluids, for example, through certain portions of the urinalysis apparatus10 as required.

The control module 50 also performs a number of other functions, including analyzing the various measured parameters to determine at least one characteristic ofthe user who provided the urine sample. For example, the control module 50 receives uroflowmetric data from the flow meter unit 52 and sensor data from the sensor unit 54 based on the urine sample provided by the user and processes this data to determine one or more characteristics of the user. The control module 50 communicates with the various components of the urinalysis apparatus 10 primarilythrough 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 Bus or HP-IB), or any other suitable communications methods known to one of skillin the art. The USB hub 62 interfaces the control module 50 to the card reader 22, the biometric scanner 24, and the display 18. In this case, the display is shown as an LCD touch display 18' (accordingly there is no keypad 20) and there isalso 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 control module 50 also has a direct connection to the display 18' to control display (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 Magtek MT-215 USB card reader system and the finger print scanner 24 can be a ZVETCOP4000-TPM finger print reader system. The camera can be a black and white CCD camera. 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/Omodule 64 is an Analog-to-Digital Converter that interfaces with the flow meterunit 52, the sensor unit 54, the urine transport assembly, the cleansing fluidtransport assembly 56, and the waste assembly 58. The I/O module 64 has multipleinput channels with high impedance inputs for receiving sensor signals from various components of the urinalysis apparatus 10 and an ADC. These digitized signals may then be digitally multiplexed either in series or in parallel and provided 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 communicate with a remote server (not shown) over a communications link. The communications link can be a secure link. The communications module 60 is a cable modem


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that can establish the secure communications link over a cable line based communications network. In alternative embodiments, the communications module 60 can be a digital subscriber line modem that can establish the secure communications link over the lines of a telephone network. Alternatively, the communications module 60 can be a wireless transceiver that can establish a secure communicationslink over a wireless network such as an 802.11 wireless local area network, a cellular network such as a Global System for Mobile Communications (GSM), a Code D

ivision Multiple Access (CDMA) network, or a 3G network. The secure communications link can be established using a transport layer security protocol (TLS) or asecure sockets layer protocol (SSL). Other communications technologies can be used, 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 auxiliary ports 70 to interact with the control module 50 and perform various operations such as calibration or maintenance. The inlet 14 receives a urine sample froma user. A portion of the urine transport assembly provides the urine sample fromthe 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 sample primarily under the influence of gravity, and without any blockages, allows the flow meter unit 52 to accurately sense the flow characteristics of the urinesample. The controller 52c is the electronic portion of the flow meter unit 52 and consists of an actuator/transducer and associated electronics that detect changes 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 module 64. The flow meter unit 52 is described in further detail with respect to FIGS. 6A-6D.

The flow rate measured by the flow meter unit 52 allows the control module 50 todetermine when a urine sample has been provided, and the volume of the urine sample. 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, the sensor unit 54 requires a certain amount of urine to be able to properly sense certain components of the urine sample. This minimum amount of urine may be onthe order of 50 ml but this depends on the configuration and the number of thesensor units. Various uroflowmetric parameters can be measured and analyzed. Forinstance, with information measured by the flow meter unit 52, the urinalysis apparatus 10 can construct a flow profile which graphs flow rate versus elapsed time. 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 beginning and the end of the actual urine sample is obtained, which is used to begin 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 urine sample prior to measurement of the parameters of interest. The filter module72 is a physical filter module consists of a fine mesh, such as a sieve, to block out foreign particles in the urine sample and prevent these foreign particlesfrom interacting with the remainder of the urinalysis apparatus 10. The filter module 72 is optional in some cases. The urine sample is then provided to the sensor unit 54 for measurement of various parameters of interest. The sensors in the sensor unit 54 sense these various parameters of interest based on whether theurine sample has certain components and then generate electrical sensor signalscorresponding to sensed parameters of interest. Signal conditioning circuitry t

hen pre-processes the sensed signals to provide reduced noise sensor signals. The pre-processing typically includes filtering and amplification. The conditionedsensed signals are then provided to the I/O module 64 which digitizes these sig


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nals.

In the exemplary embodiment shown in FIG. 2, the sensor unit 52 includes a plurality of ion selective electrode sensors 76, a sensor housing 78, and a signal conditioning module 80. The ion selective electrode sensors 76 and the sensor housing 78 are described in more detail with respect to FIGS. 7A to 7E. The sensor unit 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 and an actuator 86 are located close by the sensor unit 54 and are used to controlthe expulsion of fluids from the sensor unit 54. It should be noted that in theembodiments described herein that these types of drivers and actuators are typically implemented using a driver circuit and a solenoid valve. The solenoid valve is an integrated electromechanical device along with a pneumatic or hydraulicvalve that is actuated by the device. The driver circuit is an electronic circuit that provides the required signal to open or close the solenoid valve. The driver circuits can be implemented with a solenoid driver relay automation direct QM2N1-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 used as long as they meet specifications to prevent cross contamination of urine samples. Prior to measurement, the control module 50 sends a control signal to the driver 84 to keep the solenoid valve 86 closed so that when the urine sample is provided to the sensor unit 54, it is kept within the sensor unit 54 for an amount of time that is sufficient to allow the sensors 76 to sense various components in the urine sample. Any excess of the urine sample exits the sensor unit 54via an overflow pipe 88. The sensor signals are then pre-processed by the signal conditioning module 80. The control module 50 then provides another control signal to the driver 84 to open the solenoid valve 86 to expel the urine sample from 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 eachsensor to reduce cross-talk between the sensors. Each signal conditioning circuit 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, followed 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 filterout noise. Averaging can also be done in software by the control module 50 to further remove noise. The measured data is then converted from a voltage value toa parts-per-million value and is compared to a known concentration, typically inmmol/L, for normal urine. Those skilled in the art are familiar with how to implement the signal conditioning module 80.

Although the urinalysis apparatus 10 is shown having one sensor unit 52 based onISE sensors, it should be understood that it can have a sensor unit that is based on other types of sensors including a surface plasmon resonance sensor (see FIG. 8) and a scintillation sensor (see FIGS. 9A-10E) depending on the testing that is to be performed by the urinalysis apparatus

10. For instance, there can be different versions of the urinalysis apparatus 10that are configured to perform certain tests depending on the types of sensorsthat are used.

In addition, although only one sensor unit is shown in FIG. 2, which is described 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) sensoror scintillation sensors can be used. Accordingly, there can be embodiments in w


12/45

hich there are at least two sensor units having different types of sensors. Thedifferent types of sensors are at least two of an ion selective electrode sensor, a surface plasmon resonance sensor, and a scintillation sensor. Accordingly, there can be different embodiments of the urinalysis apparatus having an ISE sensor unit and an SPR sensor unit, or an ISE sensor unit and a scintillation sensorunit, or an SPR sensor unit and a scintillation sensor unit or an ISE sensor unit, 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 conducted by these sensor units interfere with one another. Also, the use of a serialor parallel configuration for the different sensor units can result in a more efficient implementation of the urine transport assembly and the cleansing fluidtransport assembly.

In some embodiments, additional sensor units can be added which are duplicate sensor units to provide some redundancy in the event that one sensor unit having acertain type of sensor fails. In the event of sensor failure, the urine samplecan 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 thatare determined during a one-time calibration and may be periodically updated with ongoing calibration. A given transfer function for a given sensor defines therelationship between the sensed values and the

corresponding measurements for the parameter of interest. These transfer functions are stored by the control module 50 and used to translate the sensor data todetermine the various parameters of interest. The transfer functions can be stored as lookup tables in the memory of the control module 50. In at least some embodiments, a determined value is compared against corresponding normative valuesthat represent a range of acceptable values found in representative samples of urine to determine if the determined values are outside these normal ranges. Anyabnormalities 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 sensor unit 54 and provided to the waste assembly 58 for subsequent disposal. The waste 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 anoverflow pipe 106. The control module 50 provides a control signal to the driver 90 to open the solenoid valve 92 after the sensor unit 52 has performed a measurement on the urine sample. The urine sample is then provided to the collectiontank 94. The controller 96 monitors the amount of urine in the collection tank94. When the controller 96 determines that the collection tank 94 is close to being full, the controller 96 activates the pump 98 which creates the pressure differential required to pump the urine from the collection tank 94 through the pipe 100 and the drain pipe 102 to an external drain pipe 108. Alternatively, the pump 98 can be periodically operated to empty the collection tank 94. The pump 98can be implemented with a Flotec FP0F360AC evacuation pump. The cleansing fluidtransport 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 valves 122 and 126, drivers 124 and 128, and output pipes 130 and 132. Alternatively, the solenoid valve 116 can be replaced with a pressure regulator to regulatethe 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 through the cleansing fluid transport

assembly 56 and the rest of the pipe assemblies where needed. An external watersource such as a water tap is connected to the cleansing fluid transport assembly 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 referred to as a cleansing fluid. In alternative embodiments, an external water supply may not be available proximate to the urinalysis apparatus 10 in which case


13/45

the urinalysis apparatus 10 includes a water tank (not shown) to supply the required water.

The main valve 112 is a manual valve used to allow water from the external watersource into the cleansing fluid transport assembly. In alternative embodiments,the main valve 112 can be a solenoid valve that is under electronic control. The 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 apparatus 10. The control module 50 sends control signals to the driver 114 to open the solenoid valve 116 during a cleansing mode.

Otherwise, during a measurement mode, the control module 50 sends control signals 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 distill the water. The distiller 118 can also be referred to as a deionizer. Thedistiller 118 is optional depending on the hardness of the water provided by thewater supply source. Although the ISE sensors can get damaged in the presence of distilled water, the urinalysis apparatus does not continuously operate with p

urely distilled water, but distilled water can be used momentarily to flush outthe various pipe assemblies and other fluid transport components. The water fromthe 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 inlet 14. During various stages of a cleansing mode, the control module 50 provides control signals to the driver 128 to open the solenoid valve 126 and inject water into the inlet 14 which then travels through various internal components ofthe urinalysis apparatus 10. Otherwise, the solenoid valve 126 is typically maintained in the closed position. The second

output pipe 132 includes the solenoid valve 122 and is connected to the cleansing fluid tank 120, which contains a suitable detergent, such as a hospital gradecleaning 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 stages of the cleansing mode, the control module 50 sends control signals to the driver 124 to open the solenoid valve 122 to inject the mixture into the inlet 14. The mixture then travels through various internal components of the urinalysis apparatus 10. Otherwise, the solenoid valve 122 is typically maintained in the closed position. The connectors 104 and 110 are quick disconnect connectors to easily connect to and disconnect from the external drain pipes. This allows the urinalysis apparatus 10 to be quickly setup at or removed from a site where it is tobe used. The overflow pipe 106 provides a relief mechanism if the collection tank 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 theurinalysis apparatus 10. The power supply line is a 120 V AC supply line that is connected to the power supply control panel 66 that serves as the main power control point for a power supply bus. The power supply control panel 66 includesa number of fuses or circuit breakers (not shown) to protect various componentsthat connect to the power supply bus from current surges. Accordingly, one end of the power supply bus connects to these fuses/circuit breakers and the other end of the power supply bus is connected to various components of the urinalysis apparatus 10 that require 120 V AC power. For instance, the ventilation fans (notshown), the control module 50, the USB hub 62, the printer 26, the controller 52c and the controller 96 are connected to these fuses/circuit breakers since these 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 voltage levels that are required by various components of the


14/45

urinalysis apparatus 10. For instance, the power supply converter unit 68 converts the 120 V AC supply line voltage into 12 V, 5 V, and 3 V DC supply voltage levels. The power supply converter unit 68 converts the incoming 120 V AC supply line voltage into the different supply voltage levels using appropriate step-downtransformers or converters (not shown) as is commonly known by those skilled inthe art. These different supply voltage levels are then provided as required tovarious 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 66b2 provides 24 V DC power. Other portions of the power supply bus provide 120 VAC power to various components as described above.

Referring now to FIG. 3, shown therein is a schematic diagram illustrating an exemplary embodiment of the various components of the urine transport assembly, the cleansing fluid transport assembly 56 and the waste fluid transport assembly 58. These assemblies include several pipe sections, drivers and solenoid valves.These assemblies also include t-fittings, cross- fittings, and elbow-fittings asrequired. The pipes and fittings can be made from copper, brass, stainless steel, polyvinyl chloride (PVC), or any other suitable material which is known to those 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 transport assemblies in order to gate the flow of the urine sample through various components of the urinalysis apparatus 10. The solenoid valves also open or closein order to allow or disallow cleansing fluid or another type of fluid througha 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 sample within the urine transport assembly in response to gating commands received from the control module 50.

The components of the urine transport assembly, the cleansing fluid transport assembly 56 and the waste fluid transport assembly 58 have been collectively labeled 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 portion 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 and solenoid valves 114, 122 and 126 form a portion of the fluid transport assembly 56 that was shown in FIG. 2. Another portion of the fluid transport assembly 56 includes pipe sections p2, p3-1 , p3-2, p-1 , p8-2, an

solenoi

valve 150. Pipe sections p9, p10 along with solenoi

valve 152 form the urine transport assembly. Pipe sections p11 , p12, p13-1 , p13-2, p14, p15, p16 an

p17, along withsolenoi

valves 154 an

156, an

pump 98 form the waste transport assembly 58. The collection tank 94 is not shown in FIG. 3 but it woul

be locate

right before the pump 98. The various transport assemblies have been

esigne

to utilize acombination of physical orientation, solenoi

valves an

pumps to transport various flui

s through certain components of the urinalysis apparatus 10. For example, the main valve 112 is use

to control whether water is provi

e

to the urinalysis apparatus 10. Element 114 is a pressure regulator which is use

to regulatethe pressure of the flui

as it travels through various components

uring

isinfect, cleanse an

rain mo

es (see FIG. 4). The solenoi

valve 150 is use

to control whether cleansing flui

is provi

e

to the sensor unit 54 an

subsequent components of the urinalysis apparatus 10. The solenoi

valve 126 is use

to control whether cleansing flui

is provi

e

to the inlet 14 an

subsequent components of the urinalysis apparatus 10. The solenoi

valve 122 is use

to control whether a

etergent is mixe

with water an

then provi

e

as a cleansing flui

to the 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 cleansing flui

, that has just cleanse

the inlet 14, is provi

e

to the sensor unit 54. The solenoi

valve 156 is use

to control whether air is exhauste

from t


15/45

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

these 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 exemplary embo

iment of a flow sequencing metho

170 for the urinalysis apparatus10. 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 example 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 sequencing 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 asan SPR or ra

iation sensor unit is use

, or if a combination of sensor units are use

.

The calibration mo

e 172 is optional. The calibration mo

e 172 is use

epen

ingon whether the sensors that are use

by the urinalysis apparatus 10 require perio

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 calibration at least once per

ay. Accor

ingly, in this case, the calibration mo

e

oesnot have to be

one when each urine sample is teste

but rather is performe

once

aily prior to con

ucting any urine tests for the

ay. Various calibration techniques can be use

. In one exemplary calibration technique,

uring the calibration mo

e 172, after a previous

isinfect mo

e an

cleanse mo

e, a calibration flui

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 of a urine sample that are to be measure

by the sensors 76. During the calibration mo

e 172, the sensors 76

etect the levels of these constituents in the calibration flui

, an

provi

e the measure

levels to the control mo

ule 50 as

escribe

below in relation to the test mo

e 180. The control mo

ule 50 uses this calibration

ata to characterize the sensor outputs that are provi

e

by the sensors

76, for instance, by generating an

storing a transfer function representing the

expecte

levels of a constituent of the urine for a given measure

electrical signal 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

escribe

in more

etail with regar

s to FIGS. 7A-7E. The sensor unit 54 inclu

es a sensor housing 190 that has a channel 192 with an inlet 194, an

an outlet 196. The sensor unit 54 also inclu

es an overflow port 198, an

an exhaust port 200 for the channel 192. The sensor unit 54 also inclu

es several sensor ports 202 with an outer portion that is shape

to receive an en

of the sensor 76, an

an inner portion that is large enough to allow the tip of the sensor 76 to protru

e

own into the channel 192 so that it makes contact with a flui

uring use. The sensor unit 52 also inclu

es caps 204 to plug a sensor port 202 that is not beinguse

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 coat 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 themto recover from stan

by mo

e to begin measuring

ata. The stan

ing flui

is also in pipe sections p14 an

p15. The stan

ing flui

is water that is left over after a previous cleanse an

rain mo

e. There is also water that is in most of the 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

,

raine

an

cleanse

prior to entering the stan

by mo

e 174.


16/45

When a urine test is being con

ucte

, the control mo

ule 50 configures the urinalysis apparatus 10 to operate in the pretest

rain mo

e 176. In this mo

e, the stan

ing water in the sensor housing 190 is

rawn out by opening the solenoi

valve 154. Also, a pre-test flush cycle can be

one that both rinses an

then empties various components with the help of the pump 98. The stan

ing water moves from 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 being

rawn into the inlet 14 an

the sensor unit 54.

The control mo

ule 50 then configures the urinalysis apparatus 10 to operate inthe micturition mo

e 178. In this mo

e, the user micturates (i.e. urinates) intothe inlet 14. The urine provi

e

by the user, hereafter referre

to as a urinesample, travels to the flow meter unit 52 via the pipe section p9. If there is any 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 urine sample as it passes through the flow meter unit 52 to the pipe section p10. Alternatively, 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 open an

the urine sample flows through the inlet 194 into the channel 192 of thesensor housing 190. The solenoi

valve 154 is alrea

y close

so the urine sample fills up the channel 192 an

the pipe section p15. Any overflow of the urine sample goes through the overflow port 198 into the pipe section p14 an

possiblythrough 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 micturitionmo

e 178 so as to avoi

affecting the uroflowmetric measurements ma

e by the flow meter unit 52. In a

ition, the solenoi

valve 156 is in the open state, thereby allowing air within the channel 192 to leave the sensor housing 190 as the urine sample is collecte

within the channel 192 so as to prevent any bubbles inthe 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 52 are immerse

in the portion of the urine sample within the channel 192 to measure one or more parameters of this portion of the urine sample. In alternative embo

iments,

ifferent portions of the urine sample are channele

by an altere

version of the urine transport assembly to several

ifferent sensor units that are 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 example. The length of the test time can also be

etermine

base

on

ata collecte

by the flow meter unit 52. When the flow meter unit 52

etects that there is no more flui

entering the inlet 14, the urinalysis apparatus 10 can give the user amessage on the

isplay 18 that urination shoul

continue. If urination continues, the flow meter unit 52 continues to measure the characteristics of the urineflow. If urination

oes not continue, then the urinalysis apparatus 10

eci

es that the user is

one an

procee

s to

o test the urine sample an

flush the system.

Once sensor measurement has been complete

, the control mo

ule 50 then configures 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 be 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 after 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 there is a flow of water

etecte

in pipe section p5. The pump 98 helps to accelerate the volume of water an

etergent through the various pipe sections an

othe


17/45

r components in the urinalysis apparatus 10 that receive flui

.

The

etergent travels through pipe section p5 to solenoi

valve 122 which is nowopene

. Accor

ingly, the water that was in pipe section p5 moves to pipe section p6. The

etergent then moves to pipe section p6 as the water moves to pipe section p7. The water then moves through the inlet 14 to the pipe section p9 an

the 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 can move into pipe section p10 an

the channel 192. The

etergent is then no longer provi

e

by the cleansing flui

tank 120. The

etergent follows the path thatthe 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

inthe 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 out of the channel 192 into pipe sections p14, p15 an

p16. The

etergent then moves 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

etergent moves through pipe sections p11 , p14 an

p15. As the urine sample is exiting through pipe section p17, the

etergent is traveling through pipe sectionp13-1 , p13-2 an

p16. Aroun

this time, the water is moving through the channel192 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 provi

e

to flow in pipe sections p6 an

p7, an

the inlet 14 as the remaining

etergent an

water continues to move through the other pipe sections.

The control mo

ule 50 now configures the urinalysis apparatus 10 to operate in the cleanse mo

e 184. In this mo

e, as the previous flow of water passes throughpipe 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 anew flow of water through pipe sections p3-1 an

p3-2 to the sensor unit 54. Asthis new flow of water enters the sensor unit 54 an

fills up the channel 192, the

etergent moves out of pipe section p17. This mo

e lasts long enough to cleaneach of the tips of the sensors 76. In this mo

e, water is sent through pipe sections p16 an

p17. The cleanse mo

e

184 also allows the sensors 76 to be reset to the appropriate equilibrium pointin preparation for the next set of measurements.

The control mo

ule 50 now configures the urinalysis apparatus 10 to operate in the

rain mo

e 186. In this mo

e, the solenoi

valves 152 an

154 are close

as water

rains through p11 , p13-1 , p13-2, p14 an

p16. The solenoi

valve 150 isthen close

an

water continues to

rain from pipe section p17, p3-1 an

p3-2 until stan

ing water remains in the channel 192, pipe section p15 an

part of pipesection p14. At this point, the control mo

ule 50 operates once more in stan

bymo

e. Some water is left stan

ing in the sensor unit 54 to prevent the sensors76 from being

amage

, for instance, by

rying out between tests. Accor

ingly, sufficient water is left stan

ing in the sensor unit 54 so as to coat the sensingsurfaces 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

.


18/45


19/45

et 14. For example, the inclination 262 is selecte

to maximize the flow of theurine passing through the funnel 250 thereby minimizing any re

uction in the flow rate of the urine sample. The slope of the walls of the funnel 250 can be selecte

by con

ucting 3D mo

eling an

using ray analysis to

etermine the trajectory of the urine after it contacts the insi

e walls of the funnel 250. The shape of the funnel 250 shown in FIGS. 5A-5C was seen to give acceptable results. Further, 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 in the current stream of urine then there will be a continuous stream of urine once urination resumes an

it was foun

that later streams of urine

o not interfere with previous streams of urine with regar

s to the uroflowmetric analysis that is con

ucte

. The number of interruptions an

volume of urine is measure

by the 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 urinate into the inlet 14. For female users, a separate container can be use

tourinate in an

the user can then pour the contents of the container into the inlet 14. Uroflowmetric measurements may not be as much of a concern for female users because they

o not experience the prostrate problems that male users experience.

In at least one alternative embo

iment, the inlet 14 is shape

to accommo

ate both men an

women. Also, in at least one alternative embo

iment, the inlet 14 isheight-a

justable. In this case, the inlet 14, the portion of the urine transport assembly connecting the inlet 14 an

the flow meter unit 52, as well as the flow meter unit 52 itself are couple

to a mechanism that can sli

e vertically with respect to the housing of the urinalysis apparatus 10 to change the height ofthe inlet 14 while preserving the "gravity-flow" feature of this assembly of components to allow for accurate urine flow rate measurements. In this case, the connection between the output of the flow meter unit 52 an

the sensor unit 54 isflexible 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 270 that circumscribes the upper portion of the funnel 250. The

ownwar

ly exten

ing portion of the lip has a plurality of holes 272. The portion of the lip 268 that is closer to the back wall 264 of the inlet 14 is larger than the si

e an

front portions of the lip 268. The holes 272 generally exten

along the entire circumference of the lip 268. The shape of the cleansing flui

istribution element 256 was chosen to have a larger area near the rear of the funnel 250 (i.e. near 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 cleansing flui

is

irecte

against the inner wall 274 so that a portion of the cleansing flui

follows the channel 270 to form a circumferential stream of cleansingflui

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 along the channel 270 is

irecte

through the holes 272 to form a plurality of jets of cleansing flui

. These jets of cleansing flui

are spraye

against opposingportions of the walls of the funnel 250 to thoroughly cleanse an

, in the caseof

etergent,

isinfect the funnel 250 after the user

has micturate

into the funnel 250. The skewe

or asymmetrical shape of the

istribution element 256 facilitates this "

ual-flow" of the cleansing flui

an

ensures that the inner surface of the funnel 250 is completely cleane

. Also, the pressure 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 alternative embo

iments, for certain uses of the urinalysis apparatus 10, such as ina

octor's office, where there are traine

personnel, prior to urinalysis for a


20/45

new user, the traine

personnel can fit the inlet 14 with an external liner thatis pre-sterilize

in which case the inlet 14

oes not have to be cleanse

as often.

Referring now to FIG. 5C, shown therein is an explo

e

view of the inlet 14. Triangular sha

ing is use

to show surface curvature of the components of the inlet14. 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

within the first housing element 276. An en

portion of the pipe section p7 is then 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 element 276. The en

portion of the pipe section p7 rests on groove 280 of a plate282 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

attache

to the outlet port 252 of the funnel 250. The other en

of pipe section p18 is connecte

to the inlet of the flow meter unit 52. A secon

housing element286 is attache

to the bottom e

ges of the secon

housing element 276 an

the outer e

ges of the bottom half of the plate 282. A thir

housing element 288 is then 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 ofabout 5 inches an

the length of the major axis of the mouth of the funnel 250 can 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 inches below the waist height of the average male height.

Referring now to FIG. 6A, shown therein is a schematic block

iagram illustrating an exemplary embo

iment of the flow meter unit 52. The flow meter unit 52 is capable of measuring the flow rate of a liqui

moving primarily un

er the influence 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 inlet302 an

an outlet 304, a rotating element 306

ispose

within the intake bucket300, an actuator 308 an

a sensor unit 310. Various structural components of the flow meter unit 52 such as the intake bucket 300 an

the rotating element 306can be ma

e from PVC or another suitable material.

The inlet 302 of the intake bucket 300 receives the urine sample from the inlet14 via the pipe section p9 an

the outlet 304 releases the urine sample to the pipe section p10 of the urine transport assembly as explaine

previously. The rotating element 306 is

ispose

within the intake bucket 300 an

has a plurality of 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 motor 308m can be any motor that is suitable for

riving the rotating element 306 in 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 element 306 an

the control circuitry 308c is configure

to measure

eviations fromthe nominal rotation rate in or

er to calculate the flow rate of the flui

stream. During the micturition mo

e, the urine sample contacts the rotating element306 an

changes the rate of rotation of the rotating element 306.

The changes in the rate of rotation of the rotating element 306 are proportionalto the flow rate of the urine sample.

The sensor unit 310 inclu

es an opto-interruptor mechanism in which light is

irecte

towar

s the rotating element 306 an

the rate of reflection or transmissio


21/45

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 306. For example, a rotation rate vane (not shown) can be couple

to the motor 308m so as to spin at the same rate as the rotating element 306. The rotation ratevane is typically a serrate

isk couple

to a

rive shaft 324 of the motor 308m. A light source an

a light

etector can be place

on either si

e of the rotating 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 proximate light

etector, such as a phototransistor (not shown), in the opto-interrupter mechanism. As a result of the perio

ic interruption, the phototransistor current varies at the same rate as the instantaneous rotation rate of the rotationalrate vane, an

thus represents the instantaneous rotation rate of the rotating element 306. An example configuration of the circuitry of the opto-interruptor isshown in FIG. 6D. Alternative metho

s of measuring the rotation rate of the rotating 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 Mo

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 while the DAQ mo

ule 318 can be consi

ere

to be part of the I/O mo

ule 64. The clock source 316 is optional since the flow meter unit 52 can receive a clock signal from an external

evice such as the control mo

ule 50. The

ata acquisitionmo

ule 318 is an Analog to Digital Converter (ADC) an

the PWM control block 314can be replace

with other types of control blocks executing other types of suitable control algorithms as is commonly known to those skille

in the art. The instantaneous rotation rate (i.e. the signal TACH) sense

by the sensor unit 310is use

by the PLL 312 to

etermine whether the rotating element

306 is rotating at the nominal rotation rate by comparing the measure

instantaneous rotation rate with the nominal rotation rate. The varying current signal that 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 enco

es the

ifference between the measure

instantaneous rotation rate an

the nominal rotation rate generate

by the clock source 316 that represents the pre

etermine

spin rate. The nominal rotation rate can be represente

by a perio

ic signal with an appropriate frequency. For example, for a nominal rotation rate of1500 revolutions per minute, the perio

ic signal generate

by the clock source 361 has a frequency of 3000 Hz. The PROCESS signal is provi

e

to the PWM controlblock 314 an

to the flow rate sensor

ata acquisition unit 310. The PWM control block 314 uses the PROCESS signal to a

just the rotation rate of the motor 308m so that it rotates the rotating element 306 at the nominal rotation rate. ThePWM control block 314 controls the rotation rate of the motor 308m by varying the

uty cycle of a power supply voltage that is provi

e

to the motor 308m. As aresult, the PROCESS signal provi

e

by the PLL 306 alters the

uty cycle of thePWM control block 314 to alter the rotation rate of the motor 308m. The generation of the PROCESS signal an

the a

justment of the rotation rate of the motor 308m 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 of the PROCESS signal can occur at a rate of up to 1 kHz. Similar to the other

ata acquisition units use

in the urinalysis apparatus 10, the DAQ mo

ule 318 inclu

es a signal con

itioner to filter out noise in the PROCESS signal, an amplifier to amplify the filtere

signal, an

an analog-to-

igital converter to perform

igitization. The urine falling on the rotating element 306 causes it to loserotational 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 between the measure

instantaneous rotation


22/45

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- sectional views of an exemplary embo

iment of the flow rate sensor unit 52. The rotating element 306 is a multi-bla

e impeller or fan 306' with several bla

es that intercept 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 the bla

es of the multi-bla

e fan 306'. The angle of the intake

ownspout 320 is selecte

such that the urine continues to move primarily un

er the flow of gravity to preserve the flow rate properties of the urine sample an

is also steep enough 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 areaof the bla

es or fins of the fan 306'. The motor 308m, the sensor unit 310 an

the 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 306' are fixe

to a central member 326 that is rotate

by the

rive shaft 324

riven by the motor 308m. Each bla

e of the multi-bla

e fan 306' typically has a rectangular shape an

is fixe

to the central member 326. The bla

es exten

from aspinning axis of the multi-bla

e fan an

are angle

with respect to the axis ofthe inlet 302 of the intake bucket 300 as well as being angle

away from the plane of the central member 326. This allows for increasing the surface area of each bla

e that is available for intercepting the incoming urine. Since the bla

esare 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 size

rotational elements that

o not use bla

es. The angle of the bla

es is selecte

such that the multi-bla

e fan captures an

eflects the flow of urine consistently 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 rotational 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 52primarily 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 ofthe user, the urine provi

e

by the user may have a very low flow rate an

volume. In contrast,

uring the

isinfect mo

e 182 an

cleanse mo

e 184, much largeramounts of flui

s are flushe

through portions of the flow meter unit 52 un

er high pressure in or

er to effectively

isinfect an

clean these portions of the flow meter unit 52. As a result, the mechanical components of the flow meter unit52 are

esigne

to han

le a wi

e range of flui

flow rates, pressures an

volumes. For instance, the flow meter unit 52 can generally measure urine flow ratesas low as 1.0 to 1.2 milliliters per secon

, while han

ling cleansing flui

flowrates 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 urine flow rates that may be encountere

when a user micturates. Also, the larger surface 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 flowmeasurements. In a

ition, a smaller amount of cleansing flui

is require

to sufficiently cleanse the flow meter unit 52. The multi-bla

e fan 306' typically c


23/45

ontinues to rotate

uring the

isinfect mo

e 182 an

the cleanse mo

e 184 so asto 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 anyflui

s, an

in particular cleansing flui

s

uring the

isinfect mo

e 182 an

thecleanse mo

es 184, from exiting the flow meter unit 52 other than through the intake bucket outlet 304 un

er a

variety of flow rates for these flui

s. The outlet 304 is use

to connect the flow meter unit 52 to the pipe section p9. In an exemplary implementation the intake bucket 300 can have a

iameter on the or

er of 4 inches, a height on the or

er 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 urinalysis apparatus 10. The flow meter unit 52 is calibrate

by injecting flui

sat 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

ule50 an

use

to

etermine the urine flow rate

uring the micturition mo

e 178 bycomparing 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 the measure

flow rate.

Referring now to FIG. 6D, shown therein is a schematic circuit

iagram of an exemplary embo

iment of a circuit mo

ule 330 that provi

es the functionality of thesensor unit 3

wipo wo 2009094761 20090806 received march 29 2009 farsad kiani edouard kisenko saulius brikis elias...

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