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WO2008119171A1 - Detection of urinary tract syndrome by urination onset delay in animals - Google Patents

Detection of urinary tract syndrome by urination onset delay in animals

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Publication number
WO2008119171A1
WO2008119171A1 PCT/CA2008/000596 CA2008000596W WO2008119171A1 WO 2008119171 A1 WO2008119171 A1 WO 2008119171A1 CA 2008000596 W CA2008000596 W CA 2008000596W WO 2008119171 A1 WO2008119171 A1 WO 2008119171A1
Authority
WO
Grant status
Application
Patent type
Prior art keywords
contraction
flow
detector
interval
bladder
Prior art date
Application number
PCT/CA2008/000596
Other languages
French (fr)
Inventor
Lynn Stothers
Andrew J. Macnab
Luya Li
Matthew Peter Walls
Original Assignee
The University Of British Columbia
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/20Detecting, measuring or recording for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/207Sensing devices adapted to collect urine
    • A61B5/208Sensing devices adapted to collect urine adapted to determine urine quantity, e.g. flow, volume
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2503/00Evaluating a particular growth phase or type of persons or animals
    • A61B2503/40Animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1107Measuring contraction of parts of the body, e.g. organ, muscle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08Detecting organic movements or changes, e.g. tumours, cysts, swellings

Abstract

Systems for monitoring bladder function in animals comprises a contraction detector for detecting contraction of a subject's bladder and generating a contraction signal, a flow detector for detecting flow of urine and generating a flow signal, a processor for receiving the contraction signal and the flow signal and determining an interval between the contraction and the flow, and an output device for producing an output based on the interval.

Description

DETECTION OF URINARY TRACT SYNDROME BY URINATION ONSET DELAY

IN ANIMALS

Technical Field

The invention relates to the field of urinary tract dysfunction detection.

Background

An obstruction anywhere along the urinary tract from the kidneys to the urethra, can result in increase pressure within the urinary tract and may slow the flow of urine. Obstructions may completely or partially block the urinary tract. Damage to the kidneys, stone formation and urinary tract infections may result from urinary tract obstructions. Obstructions in the lower urinary tract may be caused by, for example, benign prostatic hypertrophy (BPH), Prostate cancer and other pelvic malignancies, congenital urtheral valve abnormalities etc. Obstruction of the urinary tract may also cause a variety of problems during the voiding cycle, including urinary tract infections, urinary retention, and urine reflux.

Summary

In illustrative embodiments of the present invention, there is provided a system for monitoring bladder function in a subject, the system comprising: a contraction detector for detecting a contraction of said subject's bladder and generating a contraction signal; a flow detector for detecting a flow of urine and generating a flow signal; a processor for receiving the contraction signal and the flow signal and determining a determined interval between the contraction and the flow of urine; an output device for outputting results including the determined interval.

In illustrative embodiments of the present invention, there is provided a system described herein comprising a memory coupled to the processor for storing the determined interval.

In illustrative embodiments of the present invention, there is provided a system described herein wherein the memory stores an expected interval.

In illustrative embodiments of the present invention, there is provided a system described herein wherein the processor is configured to compare the determined interval to the expected interval and determine an interval extension. In illustrative embodiments of the present invention, there is provided a system for monitoring bladder function in a subject comprising: a contraction detector for detecting a contraction of said subject's bladder; a flow detector for detecting a flow of urine; and a timer connected to the contraction detector and the flow detector, the timer configured to start when the contraction detector detects the contraction and configured to stop when the flow detector detects the flow of urine.

In illustrative embodiments of the present invention, there is provided a system described herein wherein the contraction detector is configured to project energy toward said subject's bladder and measure scattered and reflected energy returning from said subject's bladder.

In illustrative embodiments of the present invention, there is provided a system described herein wherein the contraction detector comprises an ultrasound transducer. In illustrative embodiments of the present invention, there is provided a system described herein wherein the contraction detector comprises a mechanical detector.

In illustrative embodiments of the present invention, there is provided a system described herein wherein the flow detector comprises an optical detector.

In illustrative embodiments of the present invention, there is provided a system described herein wherein the flow detector comprises an electrical conductivity monitor.

In illustrative embodiments of the present invention, there is provided a system described herein wherein the flow detector comprises an audio detector.

In illustrative embodiments of the present invention, there is provided a system described herein further comprising a garment for supporting the contraction detector in a vicinity of said subject's bladder and for supporting the flow detector in a vicinity of said subject's urinary output.

In illustrative embodiments of the present invention, there is provided a method for monitoring bladder function in a subject comprising: detecting a contraction of said subject's bladder; detecting a flow of urine; determining a determined interval between the contraction and the flow of urine; and outputting results including the determined interval.

In illustrative embodiments of the present invention, there is provided a method described herein comprising comparing the determined interval to an expected interval to determine an interval extension. In illustrative embodiments of the present invention, there is provided a method described herein wherein outputting the results comprises outputting the interval extension.

Brief Description of Drawings

In drawings which illustrate non-limiting embodiments of the invention:

Figure 1 schematically depicts the components of a system according to one embodiment of the invention;

Figure 2 is a graph of example contraction and flow signals from the system of Figure 1;

Figure 3 schematically depicts the components of a system according to another embodiment of the invention;

Figure 4 is a flowchart illustrating the steps of a method according to another embodiment of the invention; and

Figure 5 is a receiver operating characteristic (ROC) curve for time delay between the bladder contraction and the start of the uroflow.

Figure 6 is a graph showing the change in detrusor deoxyhemoglobin, oxyhemoglobin, and cytochrome AA3 as measured by NIRS (μmol/L) as well as the uroflow (ml/sec) over time.

Detailed Description

Throughout the following description specific details are set forth in order to provide a more thorough understanding to persons skilled in the art. However, well known elements may not have been shown or described in detail to avoid unnecessarily obscuring the disclosure. Accordingly, the description and drawings are to be regarded in an illustrative, rather than a restrictive, sense.

As defined herein "a subject" may be an animal. Examples of animals include, but are not limited to: a human, non-human primate, rat, mouse, cow, horse, pig, sheep, goat, dog, cat, other domestic and non-domestic pets or captive animals, etc. The subject may have, be suspected of having or at risk for having urinary tract syndrome, urinary tract dysfunction, a urinary tract obstruction, an abnormal bladder function or a problem associated with the flow of urine. Some diagnostic methods for urinary tract syndrome, urinary tract dysfunction, various urinary tract obstructions, abnormal bladder functions and problems associated with the flow of urine and related disorders and the clinical delineation of diagnoses for urinary tract syndrome, urinary tract dysfunction, a urinary tract obstruction or a problem associated with the flow of urine and related disorders are known to those of ordinary skill in the art. Alternatively, the subject may be known to be a healthy subject that is at risk for developing urinary tract syndrome, urinary tract dysfunction, a urinary tract obstruction, an abnormal bladder function or a problem associated with the flow of urine.

As defined herein "contraction" may be understood as a measurable event associated with the contraction of a subject's bladder. In some circumstances a contraction may be the physical contraction of the bladder itself. In other circumstances a contraction may be an event, such as an electrical impulse, or a blood flow change, or a blood composition change, that is associated with the contraction of the subject's bladder. Such terminology is common in the art and may be exemplified by the electrocardiogram (ECG) in which electrical activity of the heart is an event that may be measured and is associated with the contraction of the heart. In the case of the ECG, a contraction may be either a physical contraction event of the heart or a particular electrical event that is associated with a physical contraction event of the heart. Derivatives of the word "contraction" may be similarly understood according to the context of the particular derivative.

Certain embodiments of the invention provide systems and methods for providing information useful for diagnosing obstruction of the lower urinary tract by determining an interval between the time at which a subject contracts their bladder and a time at which urine begins to flow out of the subject. The interval may be compared to an expected interval. Results based on the determined interval (which may include a length of the interval) may be stored for archival purposes and future reference and/or displayed or otherwise output to a user, for example, the subject's physician. Typically, intervals for unobstructed individuals (i.e. expected interval) may be in the range of 3-14 seconds and typical intervals for obstructed individuals is in the range of 14-45 seconds. Accordingly, an individual having an interval of between >14 seconds would be considered to be obstructed and conversely, an individual having less than or equal to 14 seconds would be considered to be unobstructed.

Figure 1 generally shows a system 10 according to one embodiment of the invention. System 10 comprises a contraction detector 20 and a flow detector 30 coupled to a processor 40. Processor 40 receives signals from contraction detector 20 and flow detector 30, and provides results to an output device 50. Contraction detector 20 is configured to detect contraction of a subject's bladder. In some embodiments, contraction detector 20 generates a contraction signal 22 upon detection of a bladder contraction. Contraction detector 20 may be configured to detect bladder contractions by directing energy towards the subject's bladder and detecting transmitted, scattered and/or reflected energy returning from the subject's bladder. Contraction detector 20 may comprise, for example: an optical energy source and an optical detector such as an infrared or near infrared detector; and may additionally include an ultrasonic energy source and an ultrasonic detector such as an ultrasound transducer. In some embodiments, contraction detector 20 may be in physical contact with the subject, and comprise a mechanical detector to which movements of the subject's bladder are physically coupled. In some embodiments, the ultrasonic energy source and an ultrasonic detector may be used to determine residual urine volume in the bladder following voiding.

Flow detector 30 is configured to detect the onset of urination. In some embodiments flow detector 30 generates a flow signal 32 upon detecting a flow of urine. Flow detector 30 may comprise an electrical conductivity monitor placed in a urine path along which the subject's urine is expected to flow, an audio detector, optical energy source and an optical detector such as an infrared or near infrared detector, or an ultrasonic energy source and an ultrasonic detector such as an ultrasound transducer.

Processor 40 is configured to determine the length of interval between the contraction of the subject's bladder and the onset of urine flow. In some embodiments, contraction and flow signals 22 and 32 may include timing information, and the interval may be determined from the timing information. In other embodiments, processor 40 may determine the interval based on the times at which contraction and flow signals 22 and 32 are received. Processor 40 may further comprise an internal clock or timer, or may be in communication with an external clock or timer, for measuring the interval.

Processor 40 provides results including the interval to an output device 50. A memory 42 may be provided for storing the results. Memory 42 may also store an expected interval. Processor 40 may compare the determined interval to the expected interval to determine an interval extension. The results provided to output device 50 may also include the interval extension. Processor 40 to a user, such as for example the subject's physician, operator, technician or the subject himself. Output device 50 may comprise, for example, a display screen, an audio device or a communication device.

In some embodiments, system 10 may comprise a garment (not shown) for supporting the contraction detector in a vicinity of the subject's bladder and for supporting the flow detector in a vicinity of the subject's urinary output.

Figure 2 is a graph showing example contraction and flow signals 22 and 32, respectively, as provided to the processor 40 by contraction and flow detectors 20 and 30, respectively. Processor 40 may compare contraction signal 22 to a threshold, and/or may detect a pattern in contraction signal 22, to detect the time of a bladder contraction, as indicated for example by line Tc in Figure 2. Likewise, processor 40 may compare flow signal 32 to a threshold, and/or may detect a pattern in flow signal 32, to detect the time of the onset of urine flow, as indicated for example by line Tf in Figure 2. The interval may be determined as the difference between Tf and Tc. In some embodiments, processor 40 may obtain an expected time of the onset of urine flow from memory 42, as indicated for example by line Te in Figure 2. The interval extension may be determined as the difference between Tf and Te.

Figure 3 generally shows a system 60 according to another embodiment of the invention. In the Figure 3 embodiment, contraction detector 20 and flow detector 30 are connected to a timer 70 by lines 24 and 34, respectively. Line 24 is connected to a start pin 72 of timer 70, and line 34 is connected to a stop pin 74, such that timer 70 starts when contraction detector 20 detects a bladder contraction, and timer 70 stops when flow detector 30 detects a flow of urine. Timer 70 may comprise a display 76 for displaying the elapsed time between contraction and urine flow.

Figure 4 generally shows a method 100 according to one embodiment of the invention. At block 110, a contraction of a subject's bladder is detected. At block 120, a flow of urine is detected. At block 130 an interval between the contraction and the onset of the flow of urine is determined. At block 140, results including or based on the determined interval are outputted to a user.

Figure 5 shows the receiver operating characteristic (ROC) curve for the time between the bladder contraction and the start of the uroflow. ROC curve is used to illustrate and evaluate the diagnostic performance of the methods. The performance of the diagnostic test depends on how well the test separates the group being diagnosed as having an obstruction from those without the obstruction. The performance is measured by the area under the ROC curve. A rough guide for classifying the accuracy of a diagnostic test is the traditional academic point system:

.90-1 = excellent (A) .80-.9O = good (B) .70-.8O - fair (C) .60-.7O = poor (D)

.50-.6O - fail (F)

A measure of the area under the ROC curve for the time in the tested population is 0.98 which indicates the test is excellent.

Certain implementations of the invention comprise computer processors which execute software instructions which cause the processors to perform a method of the invention. For example, one or more processors may implement the methods of Figure 4 by executing software instructions in a program memory accessible to the processors. The invention may also be provided in the form of a program product. The program product may comprise any medium which carries a set of computer-readable signals comprising instructions which, when executed by a data processor, cause the data processor to execute a method of the invention. Program products according to the invention maybe in any of a wide variety of forms. The program product may comprise, for example, physical media such as magnetic data storage media including floppy diskettes, hard disk drives, optical data storage media including CD ROMs, DVDs, electronic data storage media including ROMs, flash RAM, or the like. The computer-readable signals on the program product may optionally be compressed or encrypted.

Where a component (e.g. a software module, processor, assembly, device, circuit, etc.) is referred to above, unless otherwise indicated, reference to that component (including a reference to a "means") should be interpreted as including as equivalents of that component any component which performs the function of the described component (i.e., that is functionally equivalent), including components which are not structurally equivalent to the disclosed structure which performs the function in the illustrated exemplary embodiments of the invention.

Various alternative embodiments and examples of the invention are described herein. These embodiments and examples are illustrative and should not be construed as limiting the scope of the invention. Example 1

15 male (18 to 60 years) and 15 female (20 to 60 years) adult volunteers participated. All had no history of urinary tract symptoms, normal flow patters for age, and had residual urine measurements by ultrasound of less than 50cc. NIRO-300 (Hamamatsu, Japan) spectrophotometer optodes were positioned suprapubically throughout filling and emptying. During voiding NIRS and uroflow data was recorded simultaneously at 6Hz as subjects emptied into a conventional uroflowmeter. During filling, subjects lay supine with minimal body movement and were provided water ad libitum until bladder capacity was reached. A second study with simultaneous uroflow and NIRS followed by residual urine was recorded.

During emptying, mean NIRS change, in μmol*L" relative to the pre-voiding baseline were: oxyhemoglobin (HbO2) -8.38 in women vs 7.61 in men; detrusor deoxyhemoglobin (Hb) -0.76 in women vs 4.42 in men. During voiding there is a change in the concentration OfHbO2 and Hb. An example for men is shown in Figure 6. During filling, mean changes were: HbO2 10.68 in women vs -9.18 in men; Hb 4.78 in women vs -3.33 in men. NIRS patterns were reproducible within test subjects.

NIRS changes provide additional physiologic information to standard flow studies and detects non-invasively physiological changes in Hb and HbO2 that occur during the natural filling and voiding of the bladder in adults; a measure not possible with standard urodynamics using artificial filling.

While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following aspects be interpreted to include all such modifications, permutations, additions and sub-combinations. Many adaptations and modifications may be made within the scope of the invention in accordance with the common general knowledge of those skilled in this art. Such modifications include the substitution of known equivalents for any aspect of the invention in order to achieve the same result in substantially the same way. Numeric ranges are inclusive of the numbers defining the range. The word "comprising" is used herein as an open-ended term, substantially equivalent to the phrase "including, but not limited to", and the word "comprises" has a corresponding meaning. As used herein, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a thing" includes more than one such thing. Citation of references herein is not an admission that such references are prior art to the present invention. Any priority document(s) and all publications, including but not limited to patents and patent applications, cited in this specification are incorporated herein by reference as if each individual publication were specifically and individually indicated to be incorporated by reference herein and as though fully set forth herein. The invention includes all embodiments and variations substantially as hereinbefore described and with reference to the examples and drawings.

Claims

What is Claimed is
1. A system for monitoring bladder function in a subject, the system comprising: a contraction detector for detecting a contraction of said subject's bladder and generating a contraction signal; a flow detector for detecting a flow of urine and generating a flow signal; a processor for receiving the contraction signal and the flow signal and determining a determined interval between the contraction and the flow of urine; an output device for outputting results including the determined interval.
2. The system according to claim 1 comprising a memory coupled to the processor for storing the determined interval.
3. The system according to claim 2 wherein the memory stores an expected interval.
4. The system according to claim 3 wherein the processor is configured to compare the determined interval to the expected interval and determine an interval extension.
5. A system for monitoring bladder function in a subject comprising: a contraction detector for detecting a contraction of said subject's bladder; a flow detector for detecting a flow of urine; and a timer connected to the contraction detector and the flow detector, the timer configured to start when the contraction detector detects the contraction and configured to stop when the flow detector detects the flow of urine.
6. The system according to any one of claims 1 to 5 wherein the contraction detector is configured to project energy toward said subject's bladder and measure scattered and reflected energy returning from said subject's bladder.
7. The system according to any one of claims 1 to 6 wherein the contraction detector comprises an ultrasound transducer.
8. The system according to any one of claims 1 to 6 wherein the contraction detector comprises a mechanical detector.
9. The system according to any one of claims 1 to 8 wherein the flow detector comprises an optical detector.
10. The system according to any one of claims 1 to 8 wherein the flow detector comprises an electrical conductivity monitor.
11. The system according to any one of claims 1 to 8 wherein the flow detector comprises an audio detector.
12. The system according to any one of claims 1 to 11 further comprising a garment for supporting the contraction detector in a vicinity of said subject's bladder and for supporting the flow detector in a vicinity of said subject's urinary output.
13. A method for monitoring bladder function in a subject comprising: detecting a contraction of said subject's bladder; detecting a flow of urine; determining a determined interval between the contraction and the flow of urine; and outputting results including the determined interval.
14. The method according to claim 13 comprising comparing the determined interval to an expected interval to determine an interval extension.
15. The method according to claim 14 wherein outputting the results comprises outputting the interval extension.
PCT/CA2008/000596 2007-03-30 2008-03-31 Detection of urinary tract syndrome by urination onset delay in animals WO2008119171A1 (en)

Priority Applications (2)

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US92077707 true 2007-03-30 2007-03-30
US60/920,777 2007-03-30

Applications Claiming Priority (1)

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CA 2719714 CA2719714A1 (en) 2007-03-30 2008-03-31 Detection of urinary tract syndrome by urination onset delay in animals

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5853005A (en) * 1996-05-02 1998-12-29 The United States Of America As Represented By The Secretary Of The Army Acoustic monitoring system
EP1187585A2 (en) * 1999-06-29 2002-03-20 The Procter & Gamble Company Disposable article having sensor to detect impending elimination of bodily waste
WO2005034754A1 (en) * 2003-10-15 2005-04-21 The University Of British Columbia Methods and apparatus for urodynamic analysis
US20060281992A1 (en) * 2003-10-15 2006-12-14 Lynn Stothers Bladder function monitoring methods, apparatuses, media and signals

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5853005A (en) * 1996-05-02 1998-12-29 The United States Of America As Represented By The Secretary Of The Army Acoustic monitoring system
EP1187585A2 (en) * 1999-06-29 2002-03-20 The Procter & Gamble Company Disposable article having sensor to detect impending elimination of bodily waste
WO2005034754A1 (en) * 2003-10-15 2005-04-21 The University Of British Columbia Methods and apparatus for urodynamic analysis
US20060281992A1 (en) * 2003-10-15 2006-12-14 Lynn Stothers Bladder function monitoring methods, apparatuses, media and signals

Also Published As

Publication number Publication date Type
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