WO2020175927A1 - 하부요로 기능이상의 진단 시스템 및 방법 - Google Patents

하부요로 기능이상의 진단 시스템 및 방법 Download PDF

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WO2020175927A1
WO2020175927A1 PCT/KR2020/002793 KR2020002793W WO2020175927A1 WO 2020175927 A1 WO2020175927 A1 WO 2020175927A1 KR 2020002793 W KR2020002793 W KR 2020002793W WO 2020175927 A1 WO2020175927 A1 WO 2020175927A1
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pressure
patient
urinary
plot
bladder
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PCT/KR2020/002793
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English (en)
French (fr)
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오승준
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서울대학교병원
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Publication of WO2020175927A1 publication Critical patent/WO2020175927A1/ko

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202—Assessing bladder functions, e.g. incontinence assessment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202—Assessing bladder functions, e.g. incontinence assessment
    • A61B5/204—Determining bladder volume
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202—Assessing bladder functions, e.g. incontinence assessment
    • A61B5/205—Determining bladder or urethral pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/207—Sensing devices adapted to collect urine
    • A61B5/208—Sensing devices adapted to collect urine adapted to determine urine quantity, e.g. flow, volume
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A61B5/391—Electromyography [EMG] of genito-urinary organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7275—Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0075—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence by spectroscopy, i.e. measuring spectra, e.g. Raman spectroscopy, infrared absorption spectroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/22—Ergometry; Measuring muscular strength or the force of a muscular blow
    • A61B5/224—Measuring muscular strength
    • A61B5/227—Measuring muscular strength of constricting muscles, i.e. sphincters
    • A—HUMAN NECESSITIES
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7264—Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/48—Diagnostic techniques
    • A61B6/486—Diagnostic techniques involving generating temporal series of image data
    • A61B6/487—Diagnostic techniques involving generating temporal series of image data involving fluoroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/52—Devices using data or image processing specially adapted for radiation diagnosis
    • A61B6/5211—Devices using data or image processing specially adapted for radiation diagnosis involving processing of medical diagnostic data
    • A61B6/5217—Devices using data or image processing specially adapted for radiation diagnosis involving processing of medical diagnostic data extracting a diagnostic or physiological parameter from medical diagnostic data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/52—Devices using data or image processing specially adapted for radiation diagnosis
    • A61B6/5258—Devices using data or image processing specially adapted for radiation diagnosis involving detection or reduction of artifacts or noise
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4427—Device being portable or laptop-like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5215—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data
    • A61B8/5223—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for extracting a diagnostic or physiological parameter from medical diagnostic data

Definitions

  • the present invention relates to disease management, such as diagnosis of disease and decision of treatment policy based on it. More specifically, the lower urinary tract is based on biometric data obtained from urodynamic study, urodynamic test, or urodynamics. urinary tract) relates to systems and methods for providing computer-aided diagnostics of dysfunction.
  • the urinary tract refers to the entire passage through which urine is produced and discharged from the body.
  • kidney usually includes kidney, kidney, ureter, bladder, urethra, and urethra.
  • the lower urinary tract refers to the urethra, including the bladder and urethral sphincter, and the organs and structures below the bladder through which urine passes, including the entrance to the urethra.
  • the lower urinary tract function refers to the bladder and bladder muscles
  • the organs and structures involved in storing and discharging urine refer to the function of storing and discharging urine in an appropriate situation and at an appropriate time through a single or mutually cooperative interaction relationship.
  • urodynamic tests are used to identify various findings related to a specific disease or condition.
  • the urodynamic test is the single most important test in determining the prognosis and treatment of urinary dysfunction. Therefore, it is essential for the medical staff to accurately interpret the patient's urodynamic test results.
  • the term “lower urinary tract dysfunction” is used in the same meaning as lower urinary tract disease. 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793 May.
  • the healthcare practitioner can characterize and diagnose a patient's lower urinary tract dysfunction based on the measured results of the urodynamic indicators.
  • It can be influenced by a number of factors, such as the experience measured and analyzed, the preference of the medical staff to the test, environmental factors, technical errors during the test, and the physical or psychological state of the patient being examined.
  • AI artificial intelligence
  • the urodynamic test includes several sub-test items, but it is not necessary to perform all sub-test items for all patients.
  • urinary kinetics tests include uroflowmetry, filling bladder pressure.
  • the sub-detailed test items of the urethra dynamic test are the urethral pressure test.
  • a non-transitory type of computer-readable medium or media contains a sequence of one or more instructions that, when executed by one or more processors, cause a step to be performed. These steps are for the lower urinary tract to the patient.
  • a system for diagnosing an abnormality in lower urinary tract function includes one or more processors and a diagnostic engine coupled to enable communication with the one or more processors.
  • Diagnostic engine is a lower urinary tract function. It is trained to correlate data obtained from tests with one or more lower urinary tract dysfunctions and is configured to perform the following steps: receiving data from the patient's lower urinary tract function test, and the received data Extracting one or more features from the patient, identifying one or more urodynamic indicators of the patient based on the one or more characteristics, and one or more of the patients associated with one or more identified urodynamic indicators. This is the step of generating an output containing information about an abnormal lower urinary tract function.
  • Fig. 1 is a diagram for diagnosing an abnormality in lower urinary tract function according to an embodiment of the present invention.
  • 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793 This is a block diagram for explaining the acquisition of urinary data in systems and methods.
  • FIG. 2 shows the urodynamic data of the lower urinary tract system in the system and method of the present invention.
  • Figure 3 is a schematic diagram for explaining the pressure measurement of the system and method of the present invention.
  • Figures 4 and 5 show urine test data in two different patients, respectively, according to the system and method of the present invention.
  • Figure 6 shows an example of the intravesical pressure measurement data obtained in the bladder charging and urination step according to the system and method of the present invention.
  • FIG 7 shows an example of the intravesical pressure measurement data obtained in the storage step by the system and method of the present invention.
  • Figure 9 is a system and method of the present invention, during the charging and urination step, the intravesical pressure measurement
  • Figure W illustrates the data obtained during the urination phase of intravesical pressure measurement in the system and method of the present invention.
  • Fig. 11 is a function of urinary flow rate in the system and method of the present invention
  • Fig. 12 shows exemplary data from intravesical pressure measurement (when the data of the urination stage corresponds to the pressure-urinary flow test) in the system and method of the present invention.
  • Figure 13 is taken during the urethral pressure test measurement in the system and method of the present invention
  • Figure 14 is from the measurement of abdominal pressure urinary leakage pressure in the system and method of the present invention.
  • Figure 15 shows a table of urodynamic conclusions according to the classification of ICS (International Continence Society).
  • FIG. 16 is a diagram of a system for diagnosing abnormalities in lower urinary tract functions of the system and method of the present invention.
  • 17 is a schematic diagram of a data acquisition station of the system and method of the present invention.
  • Fig. 18 is a flow chart showing an exemplary process for operating a diagnostic engine in the system and method of the present invention.
  • Fig. 19 shows a computer system of the system and method of the present invention.
  • a component according to an embodiment of the present invention may be described as a separate functional unit that may include a subunit, but the component may be divided into separate components. Including a single system or integrated into a component. Are integrated together.
  • a function or operation according to an embodiment of the present invention may be implemented as a component executed in software, hardware, or a combination thereof.
  • connection includes direct connection, indirect connection through one or more intermediary devices, and wireless connection.
  • references to "one embodiment” and “preferred embodiment” mean that at least a specific feature, structure, characteristic or function described in connection with the embodiment is included.
  • One embodiment of the present invention There can be more than one.
  • FIG. 1 is a diagram for diagnosing lower urinary tract dysfunction according to an embodiment of the present invention
  • artificial intelligence can characterize the nature of specific lower urinary tract dysfunction in patients with single or multiple lower urinary tract dysfunction in order to draw urodynamic conclusions.
  • the urinary dynamics test result 186 of the fluoroscopy method may be the urinary dynamics test result (187, including several sub-inspections) and X-ray perspective data 188.
  • the artificial intelligence 192 can automatically detect and screen errors in the ureadynamic test result 186 of the perspective method before interpreting the results, thereby eliminating the screened errors. have.
  • the detected errors are based on the urodynamic conclusion of a specific patient (193).
  • the basic clinical data 180 may include various patient clinical data.
  • the basic clinical data 180 is data acquired by patient demographics, patient history, systematic review of literature, and physical examination. (181), questionnaire, urine diary, and residual urine volume (PVR) data (182), and laboratory examination
  • the patient demographic statistics may include gender, age, height, weight, body mass index, abdominal circumference, and the like.
  • the patient's medical history may include a past medical examination or surgery history, a drug history, and a current medication.
  • the patient's medical history is all previous neurological diseases, especially the lower urinary tract.
  • the data obtained from the systematic review is the erectile function and the intestinal function.
  • the information from the physical examination is the exercise of the torso, limbs, lower abdomen, genitourinary area or prostate (presence or absence of prostate hypertrophy, urogenital skin eczema or sacral skin defect due to urinary incontinence) or It includes sensory function and may be, in particular, a focused neurological examnination.
  • the result from the focused neurological examination was the degree of perineal sensation and anal tone for a light touch test and/or a pinprick test. , The presence or absence of a bulbocavemosus reflex, voluntary contraction of the anal sphincter, and fecal impaction.
  • the questionnaire may include a patient's response to a structured questionnaire associated with a lower urinary tract symptom.
  • the questionnaire may include the severity of the lower urinary tract symptoms and the quality of life of a particular patient. It is a very important tool in quantifying a patient's subjective symptoms as it can assess its impact on the quality of life.
  • the quantitative information obtained from the urination diary or the urination frequency-volume chart may include the urination frequency during the week or night time, the urination interval, the number of urinary incontinence, the average or maximum amount of urination. have.
  • the amount of residual urine may be evaluated by an ultrasonic device or urinary (urethral catheterization).
  • urinary catheterization In an example, in the laboratory test, the culture of urine microorganisms, serum creatinine level indicating the degree of kidney insufficiency (serum creatinine) level).
  • the anatomical evaluation of the urinary tract may include an imaging examination of the kidney and bladder.
  • CT and or ultrasound images of the urinary tract may show the damaged kidney, or the degree of bladder trabeculation.
  • Coins are findings suggesting compensatory hypertrophy of the bladder wall secondary to lower urinary tract dysfunction.
  • endoscopy of the bladder and urethra was performed on the presence or absence of urethral stenosis, the presence of anatomical bladder exit obstruction due to prostate enlargement in men, the presence of bladder neck incompetence, and vesicoureteral reflux (vesicoureteral). mflux), the morphology of the ureteral orifice and the degree of bladder stiffening can be identified.
  • data obtained from urodynamic tests may contain several errors or artifacts, and if these errors are not corrected quickly and accurately, it can lead to misinterpretation.
  • the present invention can include an artificial intelligence (192) algorithm that can be learned using a vast amount of inspection data accumulated in advance and has the function of automatically detecting these errors.
  • Errors or artifacts during urinary flow testing may include wag artifacts, artifacts due to uneven urination, abdominal tension, and artificial noise signals of fecal incontinence during urinary flow testing.
  • Artifacts include a distributed Pves catheter, a Pves catheter hole in contact with the bladder mucosa surface, rectal contraction, desire to urinate, spontaneous pelvic muscle contraction, involuntary detrusor muscle death before urination instruction, reduction of abdominal pressure in urination, detrusor muscle death ( after-contraction), wag artifacts in the urinary flow, and clogging of the catheter by blood clots.
  • errors or artifacts during measurement of abdominal pressure urinary leakage pressure are involuntary detrusor muscle contraction, Pves catheter slippage, abdominal pressure (Pabd) attenuation, Pabd catheter slip into rectum, pelvic floor muscles (pelvic muscle) relaxation and overestimation due to the catheter itself.
  • errors or artifacts during measurement of detrusor urinary leakage pressure include involuntary detrusor contractions and underestimation due to bladder ureter reflux.
  • errors or artifacts during pelvic muscle EMG are chargers, electromagnetic interference, weak signals, urination impulse during bladder charging, hiccups during bladder charging, and chargers. 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793 Including the guarding reflex that affects intravesical pressure, habitual contraction of the pelvic muscles before urination, paralysis of the legs, and stiffness of the lower body.
  • the present invention is to be performed based on (1) basic clinical data of the patient.
  • the item (3) is the presence or absence of a bladder cervical function failure, during the charger
  • Figure 2 shows the urodynamic data of the lower urinary tract system in the system and method of the present invention.
  • the system 100 for diagnosing an abnormality in the lower urinary tract of the present invention includes a urethral catheter 124 inserted into the bladder 108 through the patient's urethra, and for measuring intra-abdominal pressure.
  • EMG electromyogram
  • the above electrodes 120a and 120b, the imaging device 130, and a capacitive sensor (128, for example, a weight scale) for immediately determining the volume (or weight) of the liquid in the container 126, and
  • It includes a computer 132 that is electrically connected to process signals from and control these configurations.
  • the electrode 120a may be a needle electrode inserted into the anal sphincter or an intraurethral electrode inserted into the urethra to measure the activity of the urethral sphincter.
  • FIG. 3 is a schematic diagram for explaining the pressure measurement of the system and method of the present invention.
  • the rectal catheter 122 and the urethral catheter 124 may be a catheter filled with liquid, and the external pressure transducers 142 and 140 are the ends of the catheter 122 and 124.
  • the pressure (Pabd) measured by the pressure transducer (142) and the pressure (Pves) measured by the pressure transducer (140) are measured respectively. 2020/175927 1»(:1/10 ⁇ 020/002793 Can be entered.
  • each of the pressure transducers 140 and 142 is connected to a stopcock.
  • the stopcock When the stopcock is opened, a fluid meniscus is formed and the pressure of the pressure transducer is set to atmospheric pressure.
  • the height of the stopcock can be set to the top of the pubis joint (153), and Pves and Pabd can be set to 0. This process can be called "zeroing", and this is done in the systems of Figures 2 to 3 .
  • the pressure sensor of the catheter 122, 124 may communicate a wireless channel such as WiFi or Bluetooth.
  • the sensor may be a MEMS device and may be installed near the end of the catheter.
  • the container 126 may collect the liquid excreted by the patient, and the volume sensor 128 converts the weight of the liquid measured in the container 126 into an electrical signal and transmits it through a wireless channel or wire. Electrical signals can be transmitted to the computer 132.
  • volume sensor 128 may be used in place of the volume sensor 128.
  • a load cell gravimetric
  • rotating disk method can be used to measure the amount of urination and urine rate.
  • a dipstick method using the capacity technique can be used to measure the depth of urine in the container 126.
  • drop spectrometry can be used to determine urine velocity by counting the percentage of urine droplets released from the urethral meatus.
  • the electric signal from the volume sensor 128 is transmitted through a wired or wireless communication channel, and the patient's urinary velocity, urinary velocity curve pattern, and total voided volume are determined.
  • the imaging device 130 may be an X-ray perspective monitoring system for capturing images of the patient's bladder 108 and internal organs such as the urethra. have.
  • the fluoroscopic image generated by X-rays is urinary incontinence, anatomical abnormalities of the bladder or urethra, reflux to the kidney It can be captured and analyzed to diagnose lower urinary dysfunction, such as the presence of residual urine volume remaining in the bladder.
  • urine and liquid can be used interchangeably, since liquids can be injected into the bladder during various tests.
  • the patient or caregiver of the patient may use a mobile device 133 such as a mobile phone or PDA to provide baseline clinical data 180 or clinical information to a computer 132.
  • a mobile device 133 such as a mobile phone or PDA to provide baseline clinical data 180 or clinical information to a computer 132.
  • the mobile device 133 transmits basic patient clinical data to the computer 132. 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793 May.
  • the term basic clinical data refers to patient demographic statistics (sex, age, height, weight, body mass index, abdominal circumference), medical history (including neurological diseases, brain, spinal cord, spinal column, genitourinary system). Or previous surgical history in the pelvic cavity), current drug treatment, systemic review (including erectile function, bowel function, lower urinary tract symptoms), physical examination (motor or sensory function of the trunk, limbs, lower abdomen or prostate), patient's perineum, Intensive neurological examination of the anus and genitourinary system, showing the urination cycle and volume
  • patient data refers to the basic clinical data mentioned above (180) and
  • the clinical information obtained from the urodynamic test is collectively designated.
  • various types of sensors may be used in place of the sensors of the system 100.
  • a laser can be used to measure the urine velocity.
  • the pressure inside the bladder is near-infrared applied to the patient's abdominal skin
  • NIRS spectroscopy
  • the sensor 128 can be replaced by another type of sensor, such as a laser.
  • urea kinetics test are urethrametry, intravesical pressure measurement, and urethral pressure test.
  • the medical staff is in a state in which the patient is placed in a standing or sitting position.
  • uroflowmetry To measure the total volume of urination as well as urinary velocity, uroflowmetry can be performed.
  • Figures 4 and 5 are each of two different patients according to the system and method of the present invention.
  • the plot 210 may represent the volume of urine collected by the container 126 as a function of time.
  • the plot (2W) may reach a plateau, which may represent the total amount of urination in the first patient with normal urination function.
  • plot 220 may represent the urinary velocity in the first patient.
  • plots 210 and 220 can be obtained by processing the signal from the volume sensor 128.
  • plots 240 and 250 may be obtained by processing the signal from the volume sensor 128.
  • the urinary flow-EMG test is the urination pattern of the urinary intensive patient
  • a plot 230 of the EMG signal may be used to determine urethral sphincter activity.
  • bladder function should be coordinated with urethral sphincter activity (cooperative action, synergic).
  • urethral sphincter activity cooperative action, synergic.
  • the urethral sphincter should relax (reduction of EMG activity of the urethral sphincter).
  • Abnormalities in urethral sphincter activity can be determined by analyzing plot 230.
  • the urination time (224) can represent the time the patient took to urinate.
  • urinary flow 240 may have a number of local maximums (242, 244 and 246).
  • plot 250 may reach a plateau indicating the total amount of urine excreted by the second patient.
  • the reluctance time 225 (shown in plot 250) may represent a time interval between the start point of the test and the start point of urination.
  • the medical staff may measure the amount of residual urine remaining in the bladder.
  • the medical staff uses (1) a urethral catheter for discharging urine from the bladder (124), (2) a portable ultrasonic bladder scanner, or (3) a conventional ultrasonic device. Can be used.
  • medical staff may use fluoroscopic x-rays 130 to qualitatively determine the amount of residual urine.
  • the features are peak urinary speed (222, 242), urination time (224), hesitation time (225), urinary velocity curve pattern (eg, the number of peaks in the urinary flow test scale (220 or 240) (242 -246)), total urine output and residual urine volume.
  • the urinary velocity curve pattern 220 or 240 may be classified into a general bell pattern, a tower super flow pattern, a compression pattern, a high circular contraction pattern, an intermittent pattern, an intermittent strain urinary flow pattern, and a staccato pattern. .
  • the peak urinary rate (220) is too high (or too low) or urination
  • time 224 is too short (or too long), it may be suggested that the patient has a superflow (or occlusion) pattern.
  • the bladder (108) relaxes and fills the detrusor muscle, which stores urine and emptying the urine.
  • the detrusor is designed to contract during the urination phase.
  • the medical staff may perform intravesical pressure measurement (or cystometrogram as the same meaning), which may be during the storage (315, filling, filling) and urination (31, discharge, emptying) stages of the bladder. Done to investigate
  • the plot 311 shows a detrusor pressure (Pdet, detrusor pressure) 350 measured during intravesical pressure measurement, wherein the detrusor pressure 350 is intravesical pressure (pressure in the bladder, Pves, intravesical pressure) ) It is the pressure obtained by subtracting abdominal pressure (Pabd) from 330.
  • the intravesical pressure measurement is a storage (or filling) step 315 in which the medical staff can fill the bladder with liquid using a urethral catheter (124, charger, bladder intraocular pressure measurement); And the patient can empty the bladder It may include two stages of urination (316) (urinary bladder pressure test, voiding cystometry or equivalently pressure-urinary flow test, pressure-flow study).
  • a urethral catheter 124, charger, bladder intraocular pressure measurement
  • the patient can empty the bladder It may include two stages of urination (316) (urinary bladder pressure test, voiding cystometry or equivalently pressure-urinary flow test, pressure-flow study).
  • the intra-bladder pressure 330, Pves, which is the pressure inside the bladder may be measured by the pressure sensor 140 connected to the urethral catheter 124.
  • abdominal pressure 340, Pabd may be measured by a pressure sensor 142 connected to the rectal catheter 122.
  • the medical staff can fill the bladder 108 with liquid at a constant rate through the urethral catheter 124.
  • the measurement of intravesical pressure during the urination step 316 may be referred to as a pressure-urinary flow test (or, by the same meaning, a urinary intravesical pressure test).
  • the plot 320 shows the amount of liquid (ie, injected volume, infused volume, Vinf) filled in the bladder through the urethral catheter 124, where the liquid is constant during the storage step. Can be filled at speed.
  • Plots (330, 340 and 350) represent Pves, Pabd and Pdet, respectively, and plot (360) is
  • plot 350 corresponds to the storage step 315 of FIG.
  • the horizontal axis corresponds to the time. Since the bladder is charged at a constant rate during the measurement of the internal bladder pressure of the charger, the time reflects the amount of charge in the end.
  • cough a stress maneuver
  • abdominal pressure a momentary increase in abdominal pressure
  • the medical staff may instruct the patient to cough several times, where Pves and Pabd exhibit sharp peaks 322 and 332 at the same time in each cough of the same pressure amplitude.
  • the EMG signal 360 is in the plots 320, 330 and 340 of the pelvic muscles or
  • the medical staff is required to provide adequate pressure transfer from the body to the pressure sensor.
  • cough can be used for quality control of measuring equipment.
  • the medical staff can obtain important information on bladder compliance, bladder sensation, bladder capacity, detrusor function, and urethral function by analyzing data from the measurement of bladder pressure in the charger.
  • Bladder fluid purity is defined as the increase in Pdet per unit dose of liquid charged to the bladder.
  • bladder fluid purity can be classified as medium, low or high.
  • a bladder with normal fluid purity can be filled to a large volume with little increase in Pdet (350).
  • low-purity bladder is caused by various nervous system disorders, such as spinal cord injury or spinal cord disease, which can lead to decreased elasticity in the bladder wall, fibrosis of the bladder wall, or both.
  • Figure 8 is obtained in the injection and urination step by the system and method of the present invention
  • Step 315 can be generated using two plots (plot 350 of 1 Ra and plot of the amount of liquid filled in the bladder 320 of FIG. 7).
  • the Pdet may not increase significantly until the point at which the patient begins urination (373).
  • bladder sensation may also be recorded during the storage (healing) phase.
  • the healthcare provider may ask the patient to report a sensation dependent on the degree of bladder fullness.
  • the medical staff is the patient's first feeling of charge (
  • the amount of filling liquid can be determined and recorded.
  • the medical staff can detect bladder oversensitivity, reduced bladder sensation, absent bladder sensation, abnormal sensation, and nonspecific bladder recognition.
  • bladder pain can be classified as a patient's bladder sensation.
  • the healthcare practitioner can characterize the detrusor activity, such as detrusor overactivity, of the patient's bladder by analyzing data from the charger's intravesical pressure measurement.
  • Detrusor muscles and activity are spontaneous or involuntary, which may be triggered during the storage phase.
  • plots (410, 420, and 430) are of bladder (412, 422 and 432), respectively.
  • involuntary detrusor contraction (420, 430, 434, 436) may occur without urination instruction during the storage phase, where involuntary detrusor contraction may occur on its own or may be triggered by various types of stimulation.
  • involuntary detrusor contraction (420, 430, 434, 436) during the storage phase may indicate detrusor muscle and activity.
  • the bladder 422, 432 may exhibit one or more phasic contractions (434 and 436) during the initial stage of storage.
  • the plot of Fig. 9 can be used to identify urinalysis indicators and to obtain urinary kinetics conclusions.
  • the patient has phased involuntary detrusor contraction (434, 436) or end-stage
  • the patient may conclude that he or she has detrusor overactivity.
  • the bladder capacity may be determined by measuring the bladder pressure in the charger.
  • the bladder capacity is the bladder capacity at the end of the measurement of the bladder pressure in the charger.
  • Medical staff may report reasons for termination, such as "strong urgency.”
  • the maximum cystometric capacity is the amount by which a patient with normal bladder sensation exhibits a strong desire to void.
  • Bladder ureter reflux, intraprostate reflux, detrusor-sphincter coordination disorder, and obstruction of the urinary flow in men can be shown.
  • the amount of residual urine can be qualitatively indicated.
  • An X-ray fluoroscopy image from the device 130 can indicate urine leakage during abdominal pressure urine leakage pressure measurement. 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793
  • the urethral function may be determined during measurement of the charger bladder pressure.
  • the urethral function is in the standardized classification system of «
  • a bladder with normal urethral closure may not have abdominal pressure, even if abdominal pressure increases suddenly, but leakage may occur due to detrusor and activity during the storage phase. If urinary leakage occurs in the absence of bladder contraction, urethral leakage may occur. It can be classified as having a closed function.
  • the ICS will perform to classify a normal or urethral closure malfunction.
  • the medical staff performed a clinical trial based on the patient's medical history, physical examination, and the bladder neck condition evaluated by the abdominal pressure urinary leakage pressure and fluoroscopic images in an upright position. You can make an enemy judgment.
  • the medical staff was opened in the lower bladder by X-ray fluoroscopy at the time of judgment.
  • the bladder neck can be checked.
  • the detrusor leak point pressure may be measured during heavy electric bladder pressure measurement.
  • the urinary muscle urinary leakage pressure is defined as the lowest intravesical pressure at which a leak is found around the catheter during the bladder filling step (315).
  • the detrusor urinary pressure is an indicator of the detection of “high pressure bladder”, which can cause damage to the upper urinary tract in patients with neurogenic bladder.
  • the patient is evacuated in the supine position and the posterior light is emptied.
  • the bladder is filled at a predetermined charging rate, such as 5, 10 or 60 mL/min, and the patient is relieved. It does not inhibit bladder contractions and should not intentionally inhibit leakage during the filling phase.
  • Detrusor urinary leakage pressure can be defined as the pressure at which urinary leakage occurs in the absence of detrusor contraction or increase in abdominal pressure.
  • the fistula can be detected by X-ray spectroscopy or by direct visual observation of urine in the area of the external urethral meatus.
  • the measured indicator is Pves (330).
  • the urinary muscle urinary leakage pressure of more than 40 cmH20 is 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793 It can be regarded as a high-risk factor that may cause damage to the upper urinary tract in the future.
  • the urinary muscle urinary leakage pressure may be used as a predictive indicator of upper urinary tract injury.
  • the measured urinary muscle urinary leakage pressure can be taken into account when the medical staff makes a urodynamic conclusion.
  • Figure W shows exemplary data obtained during the urination phase of intravesical pressure measurement in the system and method of the present invention.
  • plots 510, 520 and 530 are measured during the urination phase.
  • Pves, Pabd, and maternal values of intravesical pressure measurement (pressure-uricology) 316 are shown, respectively, and plot 540 shows the EMG signal from the sensor 120a or 120b.
  • the EMG signal 540 detects urethral sphincter activity, and the urinary flow
  • It can be used to determine if it is cooperative or uncooperative with the urethral sphincter (i.e., to determine if it is a detrusor-sphincter cooperative disorder).
  • the activity of the urethral sphincter increases, the activity of the urethral sphincter immediately before urination begins, decreases, and the activity of the urethral sphincter can resume after urination is over.
  • patients with detrusor-sphincter coordination disorder due to certain nervous system disorders may have increased urethral sphincter activity during the urination phase.
  • plot 550 shows a urine flow measurement, i.e., urine urine velocity (Qura).
  • the plot 550 can be obtained by processing data from the volume sensor 128.
  • the medical staff may instruct the patient to cough (562, 564).
  • the medical staff should be able to determine the appropriate pressure from the body to the pressure sensor.
  • the patient can be instructed to cough before and after urination (i.e. cough can be used for quality control of measuring equipment).
  • the abrupt peaks of Pves (562, 564) and Pabd (566, 567) correspond to a pressure response to a sudden increase in total abdominal pressure.
  • the urinary flow begins to appear at the time point 552, and at the time point 556
  • the urinary flow is terminated.
  • the urinary velocity has a maximum value (the highest urinary velocity) at the time point (554).
  • time points 532 and 534 are the start and end points of urination, respectively (552 and 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793
  • the maximum urinary urinary pressure (detrusor pressure at Qmax, PdetQmax) (580) is the urinary pressure at the point where the urinary velocity Qura is the maximum during the urinary phase
  • Detrusor pressure at Qmin (PdetQmin) (582) is the minimum urinary pressure during the urinary phase, and open detrusor pressure (532) is the urinary pressure at the onset of urination.
  • Closing urination muscle pressure 534 is the urination muscle pressure at which urination ends.
  • FIG. 11 shows a plot of detrusor pressure as a function of urinary velocity in the system and method of the present invention.
  • plots 530 and 550 may be used to generate plots 6W.
  • the entire domain of the plot 600 can be divided into three areas: an obstructed area, an unobstructed area, and an equiivocal area.
  • the plot (6W) is an unoccluded area. Because it is in, it can be concluded that the bladder outlet is not blocked.
  • the plot of Pdet vs. Qura may have a pattern similar to plot 620.
  • the patient can conclude by showing a mechanical bladder outlet obstruction (BOO).
  • BOO mechanical bladder outlet obstruction
  • the pattern of the plot of the Pdet large urine flow can be used as a feature to obtain a urine dynamic conclusion.
  • Bladder outlet obstruction index (BOO index) can be derived.
  • Male bladder outlets can be classified as closed, unclear and non-closed according to the BOO index (eg, BOO index ⁇ 40 (closed); 20 ⁇ BOO index ⁇ 40 (unclear); and BOO index ⁇
  • the X-ray image from the device 130 is used during a pressure-urinary flow test to determine various indicators such as bladder contraction, such as bladder ureter reflux, prostate reflux, detrusor-sphincter coordination disorder, and bladder cervical insufficiency.
  • bladder contraction such as bladder ureter reflux, prostate reflux, detrusor-sphincter coordination disorder, and bladder cervical insufficiency.
  • the time of urination (590) represents the range of time to empty the bladder.
  • Detrusor underactivity is the strength and/or persistence of bladder bladder.
  • plot (Gi 0) could represent the maternal spar of the normal bladder (Gi 2), while plot (720) could represent the Pdet of (722) of the underactive detrusor muscle.
  • the low-active bladder 72 ie the bladder with low-active detrusor muscles, may contract to a reduced intensity and not achieve complete bladder emptying.
  • BCI bladder contractility index
  • BCI PdetQmax + 5*Qmax.
  • the medical staff can conclude that the bladder has weak contractility when the BCI is less than 100 (normal contractility when the BCI is in the W0-150 range, strong contractile when the BCI is greater than 150).
  • bladder voiding efficiency (BVE), which is defined as a percentage according to the following equation.
  • BVE (Urinary volume/Total bladder volume) xlOO
  • the medical staff can qualitatively measure the amount of residual urine using the X-ray fluoroscopic imaging device 130 after the urination is completed.
  • the medical staff injects a contrast agent inside the bladder through the urethral catheter 124, acquires a fluoroscopic image generated by the X-ray fluoroscopic imaging device 130, and uses this image to estimate the amount of residual urine.
  • the external urethral sphincter (hereinafter, the urethral sphincter or sphincter) is located just below the prostate line (110) and controls the opening/closing of the flow of urine from the bladder (108).
  • the medical staff inserts the urethral catheter 124 into the bladder 108 and continuously injects the liquid into the bladder at a predetermined ratio through the second hole of the catheter, while the urethral catheter 124 is It can be withdrawn slowly along the urethra at a set constant withdrawal rate.
  • the urethral catheter 124 is located in the distal portion of the catheter
  • the catheter is withdrawn at a constant rate along the urethra and the liquid is 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793 During injection through the hole, the intravesical pressure (820, Pves) can be continuously measured by a pressure sensor located near the first hole of the catheter, and the urethral pressure (850 , Pura) can be continuously measured by a pressure sensor located near the second hole of the catheter.
  • the plot 820 is measured through a hole located at the tip of the catheter.
  • Plot 850 shows the urethral pressure measured through the second hole (Pura) at the end of the catheter.
  • Plot 860 represents the urethral obstruction pressure corresponding to Pura 850 subtracted by Pves 820.
  • the maximum urethral obstruction pressure 866 is from the maximum urethral pressure 864
  • the maximum urethral obstruction pressure (866) is 68cmH20 and the maximum urethral pressure (864) is
  • pressure 868 may represent the resting bladder pressure and width 862 may represent the length (functional profile) of the portion of the urethra where the urethral pressure is higher than Pves.
  • the resting area light internal pressure may be 6 cmH20
  • the functional profile length can be 74 mm.
  • the maximum urethral pressure, the maximum urethral obstruction pressure, and the functional profile length can be used to identify indicators representing the static and functional aspects of the urethra.
  • the stress urinary leakage pressure is the severity and tolerability of stress urinary incontinence.
  • APP abdominal urinary pressure
  • VLPP Valsalva pressure urinary leak pressure
  • CLPP cough-induced abdominal pressure urinary leak pressure
  • VLPP represents the value of intravesical pressure (910, Pves), which means that there is no detrusor muscle contraction.
  • plots (910, 920, 930 and 940) show Pves, Pabd, Pdet, and EMG signals, respectively, and the plot of FIG. 14 can be obtained in a manner similar to the plot of FIG. 7.
  • the medical staff instructs the patient to cough several times as indicated by the sudden peak point 902 in the figure, and the X-ray perspective image using the imaging device 130 is displayed. Cough-induced urinary incontinence (involuntary urine leakage) can be identified.
  • the practitioner can determine the cough-induced abdominal pressure (912), which corresponds to the minimum cough-induced abdominal pressure that caused the patient to urinate. 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793
  • the healthcare practitioner can check the abdominal urinary leakage pressure 922, which corresponds to the minimum abdominal compression pressure at which the patient leaks urine.
  • the urine leakage is the point at which abdominal urinary leakage pressure occurs. Can be important in determining
  • the measured Valsalva abdominal pressure urinary pressure and cough-induced abdominal pressure urinary leakage pressure determine the severity of abdominal pressure urinary incontinence and endogenous urethral deterioration, a urodynamic indicator that can be used to obtain urodynamic conclusions. admit.
  • Fig. 15 shows a table of urodynamic conclusions according to the classification of ICS (International Continence Society).
  • each item in Table W00 is more than one lower urinary tract function.
  • It may be a corresponding clinical or urodynamic indicator (or simply an indicator).
  • the medical staff can conclude that the patient's bladder is overactive (detrusor and activity).
  • Fig. 16 is a diagram of a system for diagnosing abnormalities in lower urinary tract functions of the system and method of the present invention.
  • the system 1100 includes a data acquisition station (1 W2) for acquiring data from basic clinical data (180) or ureadynamic test results (186), and a database for storing data ( 1 A network through which a diagnosis system (1104), including a diagnosis engine (H08) for diagnosing lower urinary tract dysfunction of a patient based on W6) and data, and a data acquisition station (1102) and diagnosis system (1104), can communicate with each other.
  • a diagnosis system (1104 including a diagnosis engine (H08) for diagnosing lower urinary tract dysfunction of a patient based on W6) and data
  • a data acquisition station (1102) and diagnosis system (1104 can communicate with each other.
  • urea dynamics test result (186) refers to the test described in conjunction with Figs. 2 to 9).
  • the system 1100 may include other devices connected to the network 1112.
  • the diagnostic system 1104 can detect the diagnosed fault with a computer of a medical staff connected to the network 1112 (not shown in FIG. 16). Not).
  • a computer of a medical staff connected to the network 1112 (not shown in FIG. 16). Not).
  • Database 1120 is a data acquisition station (H02) and diagnostics
  • each of the two components 1102 and 1104 may be a computer.
  • one or more elements of component 1102 and/or 1104 may be implemented as a separate computing facility; for example, database 1106 is physically separated from diagnostic engine 1108 and communicatively connected. Can be
  • Figure 17 is a schematic diagram of a data acquisition station of the system and method of the present invention.
  • the data acquisition station 1102 may be similar to the computer 132 of FIG. 2.
  • the data acquisition station (1 W2) is like a microprocessor for operating/adjusting the other components of the data acquisition station.
  • a sensor/camera controller 1210 for controlling the memory 1206, a display 1208 for displaying various images, and various sensors/electrodes and imaging devices 130 of FIGS. 2 and 3 to acquire data therefrom.
  • an image processor 1212 for processing and analyzing images such as X-ray and ultrasonic images received from the imaging device 130, and a signal processor 1214 for processing signals acquired by the sensor/camera controller 1210 ) And, connected to the network (1112)
  • a communication unit 1216 for communicating data with various external devices such as sensors and imaging devices as well as nodes/stations, power cables, Includes one or more ports (1218) to accommodate various terminals.
  • the sensor/camera controller 1210 is
  • the imaging device 130 can be controlled to obtain an image of an internal organ such as the bladder 108, and the imaging device 130 can be an X-ray perspective image monitoring system.
  • the sensor/image controller 1210 may control the sensor/electrode to obtain the signal shown in FIGS. 4 to 14.
  • the user interface 1204 may include a keyboard and/or a mouse for entering patient basic clinical data.
  • the display 1208 allows the user to interact with the data acquisition station 02. It could be a touch screen that lets you do it.
  • the port 1218 is the sensor of Figures 1 to 2 to acquire data
  • a variety of terminals can be accommodated to communicate signals to the station 1102.
  • port 1218 may comprise a wireless communication connection that communicates a wireless signal with the sensors of FIGS. 2 to 3.
  • the diagnostic engine 1108 acquires data
  • the station 02 By receiving data from the station 02 and analyzing the received data, it is possible to diagnose a patient's lower urinary tract dysfunction, where the data received may include data from urodynamic tests and patient basic clinical data.
  • the diagnostic engine 08 may be software, a hardware device, or a combination thereof.
  • the diagnostic engine 1108 may include an artificial intelligence (Show 1) algorithm.
  • the diagnostic engine 08 extracts features from the received data, and basic clinical data and/or The results of urodynamic indicators can be identified, and the patient's lower urinary tract dysfunction can be characterized from basic clinical data or the identified results of urodynamic indicators.
  • the diagnosed lower urinary tract dysfunction may include one or more of the items in Table 00.
  • the diagnostic engine 1108, from the data shown in Figures 4 to 14 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793 Characteristic can be given.
  • the AI algorithm can extract the features described in relation to 4 to 9 even by replacing the medical staff.
  • the characteristics of the data acquired during the urination phase of the intravesical pressure measurement can be extracted, and the above-described characteristics are the maximum flow rate (Qmax), the maximum urinary muscle pressure.
  • BOO index bladder exit occlusion index
  • BCI bladder contraction index
  • BVC bladder urination efficiency
  • Indicators such as maximum urethral pressure, maximum urethral closure pressure, total profile length, and functional profile length are included.
  • the diagnostic engine 1108 is a major lower urinary tract symptom, the patient's medical
  • Indicators can be extracted from data 180.
  • the diagnostic engine (1 W8) may be trained by a supervised learning process.
  • the diagnostic engine 1108 can use training data, where each of the training data can contain a pair of input objects and a desired output object.
  • the input object may include one or more data from basic clinical data 180 and ureadynamic test results 186, such as plots/data shown in Figures 4-14, wherein the desired output object May be associated with the input object and include the patient's lower urinary tract dysfunction listed in Table W00.
  • a trained medical staff may analyze a large number of input objects and diagnose a patient's lower urinary tract dysfunction for each input object to prepare a desired output object.
  • the trained diagnostic engine (1 W8) receives a new input object and 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793 Can be used to diagnose lower urinary tract dysfunction.
  • FIG. 18 is a flow chart showing an exemplary process for operating a diagnostic engine in the system and method of the present invention.
  • step 1302 the diagnostic engine 1108 collects data related to lower urinary tract malfunction.
  • diagnostic engine 18 may be trained to associate data with one or more lower urinary tract dysfunctions.
  • the received data may include data from a ureadynamic test result 186 and basic clinical data 180 generated from a clinical evaluation (as discussed in connection with Figures 4 to 14). .
  • the diagnostic engine 1108 may give one or more characteristics from the received data.
  • the diagnostic engine 1108 is based on the extracted features, one or more results of the patient's basic clinical data 180 and/or the results of urodynamic tests (186, or urodynamic indicators). Can be identified.
  • the data received by the diagnosis engine 1108 is shown in the plots 210, 240, 220, 230 and 250 of Figs. Can be included, and these plots can be obtained from urine flow measurements and represent urine speed, EMG signal and volume of urine, respectively.
  • the diagnostic engine 1108 can extract a feature from the input data, wherein the feature is a plot of urination 240, the maximum amount (222, 242), urination time (224), It can be the hesitation time, the total amount of urination, and the amount of residual urine.
  • the diagnostic engine 08 may use the extracted features to identify a urodynamic indicator (or simply an indicator) associated with a patient's lower urinary tract dysfunction.
  • the diagnostic engine 1108 can conclude that the patient's urine flow is normal.
  • the peak urinary rate (220) is too high (or too low), urination
  • the diagnostic engine 1108 can identify the superflow (or occlusion) pattern.
  • the data received by the diagnostic engine 08 may include one or more plots (320, 330, 340, 350 and 360) of Fig. 7, which plots may be taken during the storage phase of the bladder measurement. There, Each signal is displayed.
  • the horizontal axis corresponds to the time. 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793 Since the central bladder is charged at a constant speed, the time reflects the amount of charge in the end.
  • the diagnostic engine 1108 may use these plots 311, 3, 376.
  • the diagnostic engine 1108 is 3A to 3C
  • the features can be extracted from the plot to check the bladder compliance, where the features are the bladder fill curve during the storage phase (376), the first sensation of filling and the first desire of the patient. to void), and bladder volume when a strong desire to void is felt.
  • the diagnosis engine 1108 is judged to be low bladder capacity. can do.
  • the data received by the diagnostic engine 1 W8 may include plots 330 and 350 of FIG. 7, and these plots may represent Pves and Pdet, respectively.
  • the diagnosis engine 1108 measures the urinary muscle urinary leakage pressure.
  • the included features can be extracted, and based on the extracted features, the diagnostic engine (H08) can identify urodynamic indicators as a prognostic risk factor that damage to the upper urinary tract, such as height, will occur in the future.
  • the diagnostic engine 1108 may generate plots 410, 420, and 430 of FIG. 9 using the data 320, 330, 340 and 350 received by the diagnostic engine 1108. Where data can be obtained from the storage phase of intravesical pressure measurements.
  • the diagnostic engine 1108 extracts features such as the number of involuntary detrusor contractions during the storage phase, and the phase performance number when a number of involuntary detrusor contractions occur during the storage phase. You can grasp the axis.
  • the diagnostic engine 1108 is used for involuntary detrusor muscle contraction during the storage phase.
  • the diagnostic engine (1 W8) can also receive X-ray images to extract features of the bladder neck (open or closed) and features such as leak detection from X-ray images.
  • the data received by the diagnostic engine 1108 may include plots (510, 520, 530, 540 and 550) of FIG. 10, and these plots are Pves, Pabd, Pdet, EMG, and It shows the urinary speed.
  • the diagnostic engine (1 W8) uses the input data in Figs. 11 and 7 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793 plot (610, 710, 720)) can be created.
  • features can be extracted from the data and various results can be identified from the features, where the features are peak urinary speed (554), open urinary pressure (532), closed urinary pressure (534), total urinary volume, pressure (Pdet)-pattern of urinary flow plot. (610, 620), peak urinary urinary pressure during the urinary phase
  • the diagnostic engine 1108 can identify detrusor underactivity if the peak detrusor pressure (Pdet) is low during the urination phase.
  • the diagnostic engine 1108 can identify the bladder outlet obstruction.
  • the data input to the diagnostic engine 1108 may include plots 810, 820, 830, 840, 850 and 860 of FIG. 13, and these plots are acquired during urethral pressure test measurement, EMG signals, intravesical pressure, abdominal pressure, detrusor pressure, urethral pressure near the catheter tip, and urethral closure pressure.
  • the diagnostic engine 1108 may generate lots of urethral obstruction pressure 860 using plots 820 and 850.
  • the diagnostic engine 1108 may give a characteristic from the plot of FIG. 13, wherein the characteristic is a maximum urethral pressure 864, a urethral closure pressure. ) And functional profile length.
  • step 1306 the diagnosis engine is when the maximum urethral obstruction pressure 864 is low
  • Indicators such as indirect evidence of sphincter incompetence can be identified
  • plots 810, 820, 830 and 840 are similar to the corresponding plots in FIG. 7. That is, plots 810, 820, 830 and 840 represent EMG signals, bladder pressure, abdominal pressure, and urinary muscle pressure. Show.
  • Plot 850 shows the pressure measured at the catheter 124 end 182
  • the plot 860 is the pressure difference between the pressure 850 measured at the catheter end 182 and the intravesical pressure 820.
  • the pressure difference can be referred to as the urinary pressure.
  • the data received by the diagnostic engine 1108 may include plots (910, 920, 930 and 940) of Fig. 14, and these plots represent Pves, Pabd, Pdet and EMG signals, respectively.
  • the diagnostic engine 1108 is
  • VLPP stress urinary leakage pressure
  • CLPP cough-induced abdominal pressure urinary pressure
  • step 1308 the diagnostic engine 1108 is associated with the identified urodynamic indicator.
  • the identified urodynamic indicator may include one or more items of Table W00.
  • a patient's lower urinary tract dysfunction may be related to one or more abnormal basic clinical data (180) or urodynamic indicators, and that different lower urinary tract dysfunction may have common indicators.
  • step 13 W the output can be transmitted to the medical staff's computer so that the patient's lower urinary tract dysfunction can be diagnosed and treated.
  • a patient without an anus after rectal cancer surgery may have a bowel movement through an abdominal stoma.
  • a rectal catheter 122 may be inserted through an abdominal stoma to measure abdominal pressure.
  • a suprapubic cystostomy previously installed in the lower abdomen (suprapubic cystostomy). catheter).
  • the humerus bladder lumbar catheter may also be considered to serve as the catheter 124 and the intravesical pressure may be measured.
  • the data of FIGS. 4 to 9 may be obtained in a standard urodynamic test, where the patient is in a fixed position during the test.
  • the same data can be obtained in an ambulatory urodynamic study, where the patient can be moved with a urodynamic pressure transducer and signal recorder during the examination.
  • one or more computing systems may be configured to perform one or more of the methods, functions, and/or operations presented herein.
  • a system that implements at least one or more of the methods, functions and/or operations described in this specification may include an application or application running on at least one computing system.
  • a computing system may contain one or more computers and one or more databases.
  • a computer system may be a single system, a distributed system, a cloud-based computer system, or a combination thereof.
  • the present invention may be implemented in any instruction execution/calculation device or system capable of processing data including, but not limited to, laptop computers, desktop computers and servers.
  • the present invention can also be implemented in other computing devices and systems.
  • embodiments of the present invention can be implemented in various ways including software (including firmware), hardware, or a combination thereof.
  • Components one or more application-specific integrated circuits (ASICs) and/or 2020/175927 1»(:1 ⁇ 1 ⁇ 2020/002793 Can be performed by components implemented in various ways including program control.
  • ASICs application-specific integrated circuits
  • FIG. 19 An exemplary system 1400 that can be used to implement is described with reference to FIG. 19.
  • the computing device described in connection with FIGS. 1 to 17 may include one or more components in the system 1400. As shown in FIG. 19, the system 1400 provides computing resources and controls the computer. It includes a central processing unit (CPU) 1401.
  • CPU central processing unit
  • the CPU 1401 may be implemented with a microprocessor, etc., and may include a graphic processor for mathematical calculations and/or a floating point coprocessor.
  • System 1400 may include system memory 1402, which may be in the form of random-access memory (RAM) and read-only memory (ROM).
  • RAM random-access memory
  • ROM read-only memory
  • Input controller 1403 represents an interface to various input devices 1404 such as a keyboard, mouse, or stylus.
  • the input controller 1403 may have a scanner controller 1405 in communication with the scanner 1406.
  • System 1400 is a storage device to interface with one or more storage devices 1408
  • a controller 1407 may be included, each of which is a storage medium such as a magnetic tape or disk, or an optical medium that can be used to record an instruction program for an operating system, utility, or a program implementing various embodiments of the present invention. Contains applications that can be included.
  • Storage 1408 may also be used to store data processed or data to be processed according to the present invention.
  • System 1400 is a cathode ray tube (CRT), thin film.
  • CRT cathode ray tube
  • a display for providing an interface to a display device 1411 which may be a transistor (TFT) display, or other type of display.
  • TFT transistor
  • Controller 1409 may be included.
  • the system 1400 may also include a printer controller 1412 for communicating with the printer 1413.
  • the communication controller 1414 can interface with one or more communication devices 1415, which means that the system 1400 can interface with the Internet, Ethernet cloud, FCoE/DCB cloud, local area network (LAN), WAN (Wide Area Network), It allows connection to a remote device through any of a variety of networks, including a storage area network (SAN), or through an appropriate electromagnetic carrier signal including infrared signals.
  • communication devices 1415 which means that the system 1400 can interface with the Internet, Ethernet cloud, FCoE/DCB cloud, local area network (LAN), WAN (Wide Area Network), It allows connection to a remote device through any of a variety of networks, including a storage area network (SAN), or through an appropriate electromagnetic carrier signal including infrared signals.
  • bus 1416 can represent more than one physical bus.
  • the various system components may or may not be physically close to each other.
  • input data and/or output data may be transmitted remotely from one physical location to another.
  • a program implementing various embodiments of the present invention may be provided at a remote location (eg For example, it can be accessed from the server).
  • Such data and/or programs may contain hard disks, floppy disks and magnetic
  • Magnetic media such as tapes; optical media such as CD-ROMs and holographic devices; optical magnetic media; and programs such as application-specific integrated circuits (ASICs), programmable logic devices (PLCs), flash memory devices, ROM and RAM devices It may be transmitted through a variety of machine-determinable media including, but not limited to, hardware devices specifically configured to store or store code.
  • ASICs application-specific integrated circuits
  • PLCs programmable logic devices
  • flash memory devices ROM and RAM devices
  • the one or more non-transitory computer-readable media shall contain volatile and nonvolatile memory.
  • Hardware implementation functions are ASIC, programmable array, digital signal processing circuit
  • any claim is intended to include both software and hardware implementations.
  • computer-readable medium or medium refers to the instructions embodied thereon. Includes software and/or hardware with programs or combinations thereof.
  • embodiments of the present invention may also relate to computer products having a non-transitory type of computer-readable medium having computer code for performing various computer-implemented operations.
  • They may be ones that are notified to the person concerned and are available for use.
  • Examples of [378] types of computer-readable media are hard disks, floppy disks, and magnetics.
  • Magnetic media such as tapes; optical media such as CD-ROMs and holographic devices; optical magnetic media; and programs such as application-specific integrated circuits (ASICs), programmable logic devices (PLCs), flash memory devices, and ROM and RAM devices
  • ASICs application-specific integrated circuits
  • PLCs programmable logic devices
  • flash memory devices and ROM and RAM devices
  • Examples of computer code include machine code generated by a compiler and a computer
  • This embodiment of the present invention may be implemented in whole or in part as machine executable instructions that may be present in a program module executed by a processing device.
  • Examples of program modules include libraries, programs, routines, objects, components, and
  • program modules can be physically located in one or more of the local and remote locations.
  • the present invention can be used in all industries related to the diagnosis of lower urinary tract dysfunction.

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Abstract

본 발명은 의료진이 환자의 하부요로 기능이상을 평가하고 치료하는 것을 돕기 위해, 다양한 검사로부터의 얻은 많은 양의 데이터에 기초하여 AI 알고리즘을 훈련시키고, AI 알고리즘을 적용하는 하부요로 기능이상의 진단 시스템 및 방법에 관한 것이다.

Description

2020/175927 1»（：1/10公020/002793 명세서
발명의 명칭:하부요로기능이상의진단시스템및방법 기술분야
[1] 본발명은질환의진단및이에기반한치료방침의결정등질환관리에관한 것으로,보다상세하게는요역동학검사 (urodynamic study, urodynamic test또는 urodynamics)로부터얻어진생체데이터에기초하여하부요로 (lower urinary tract) 기능이상 (dysfunction)의컴퓨터보조진단을제공하기위한시스템및방법에 관한것이다.
배경기술
四 요로 (urinary tract)라함은소변이생산되어몸밖으로배출되는통로전체를
말하며통상신장,신우,요관,방광,요도,요도구를포함한다.
[3] 하부요로 (lower urinary tract)라함은방광과요도괄약근 (urethral sphincter)을 포함한요도및요도입구를포함하여소변이통과하는방광이하의생체 구조물들과장기들을통칭한다.
[4] 하부요로기능 (lower urinary tract function)이라함은방광과방광근육,
요도괄약근,골반근육,전립선등소변을저장하고배출하는데관련된장기들과 구조물들이단독또는상호협조적인작용관계를통해적절한상황과적절한 시점에소변의저장과배출을이루는기능을말한다.
[5] 요역동학검사 (urodynamic study)는요도괄약근 (ure比 iral sphincter)과방광이
소변을저장하고배출하기위해어떻게기능하는지를평가하는검사이다.
그리고요역동학검사는특정질병이나상태와관련된다양한소견들을 확인하는데사용된다.
[6] 의료진은요역동학검사결과에기초하여단일질환 (single disease
entity)에서라도나타날수있는다양한유형들의방광/요도기능이상을명확하게 구별할수있다.일반적으로의료진은하부요로기능이상/질병의특성을 진단하는데필요한상세정보를얻기위해요역동학검사를수행하며,이로써 환자에게적용가능한최상의치료방법을제공할수있다.
[7] 환자가다른엔티티 (entity)의하부요로기능이상을갖고있더라도,요역동학적 패턴은다른엔티티의그것과유사할수있다.따라서,환자의특정하부요로 기능이상의 예후및치료는다른질환개체의경우와유사하거나심지어동일할 수도있다.
[8] 요역동학검사의주요역할중하나는특정요로기능이상을가진환자의
예후를결정하고치료계획을수립하는것으로,요역동학검사는요로기능 이상의 예후와치료를결정하는데있어가장중요한단일검사이다.따라서 의료진은환자의요역동학검사결과를정확하게해석하는것이필수적이다. 여기서하부요로기능이상이라는용어는하부요로질환과같은뜻으로사용될 2020/175927 1»（：1^1{2020/002793 수있다.
[9] 일반적으로,요역동학검사는소변의 저장및배출기능과관련된다양한
지표들을식별하는여러 세부테스트들을포함한다.의료진은요역동학적 지표들의측정된결과에 기초하여환자의하부요로기능이상을특정하고 진단할수있다.
[1이 그러나의료진의요역동학검사결과의 해석은의료진이 평가지표들을
측정하고분석한경험,테스트에 대한의료진의선호도,환경적요인,검사중 기술적오류,피검환자의신체적또는심리적상태등과같은여러요인에 의해 영향을받을수있다.
[11] 결과적으로,동일한하부요로기능이상이라도의료진의판단에따라서다른 요역동학적 결론에도달할수있으며,이는하부요로기능이상이 잘못진단되어 부적절한치료를초래할수있다.
[12] 추가적으로,요역동학검사를위한분류시스템이 현존한다.구체적으로는, 국제요실금학회 (ICS, International Continence Society)는하부요로기능이상과 관련된증상,증후,요역동학적측정기법 및요역동학적소견들을정의하고 있는데,이는지금까지의료계에서 가장널리 인정되는표준화된정의이다.
[13] 그러나, ICS는각하위세부검사들에서정상또는비정상결과의특정 값에 대한정의를제공하지 않기 때문에 의료진은요역동학검사후결과를
임상상황을고려하여자의적으로해석한다.따라서요역동학검사의 결과에 대한최종해석과이에따른의료진의 임상적판단은의료진의주관에의존되는 부분이 많을수밖에 없다.
[14] 최근에,인공지능 (AI, artificial intelligence)알고리즘은환자의질병을진단하기 위해다양한분야에서 이용되고있다.일반적으로 AI시스템에는그시스템을 학습시킬목적으로데이터베이스가필요하다.이 데이터베이스는표준화된 테스트프로토콜에따라이미 체계적으로측정되고기록된많은양의 데이터를 포함하고있어야한다.
[15] 현재까지하부요로기능이상과관련된충분한데이터가없었기 때문에,환자의 하부요로와관련된기능이상을진단하기위해 적용할수있는 AI시스템은 존재하지 않는다.
[16] 요역동학검사는여러 가지의하위 세부검사항목들을포함하지만,모든환자에 대해모든하위 세부검사항목들을수행할필요는없다.
[17] 예를들어,요역동학검사에는요류측정술 (uroflowmetry),충전방광내압
즉정술 (filling cystometry)및압력 -요류검사 (pressure-flow study,또는 voiding cystometry)와같은여러하위 세부검사항목들이포함되며,이검사들은거의 모든환자에서수행된다.
[18] 그리고이 외의요역동학검사의하위세부검사항목들로는요도단압검사
(Urethral Pressure Profile),복압성요누줄압 (ALPP, Abdominal Leak Point Pressure) 즉정 및배뇨근요누줄압 (DLPP, Detrusor Leak Point Pressure)즉정과같은다른 2020/175927 1»（：1^1{2020/002793 하위테스트항목들도포함되는데,이는환자가가진특정질병/조건에서 선택적으로수행된다.
[19] 따라서,특정환자에게어떤종류의하위세부검사항목들을수행해야
하는지에대한지침을제공할수있는시시스템이필요하다.
발명의상세한설명
기술적과제
[2이 의료진이환자의하부요로기능이상을평가하고치료하는것을돕기위해, 다양한검사로부터의얻은많은양의데이터에기초하여시알고리즘을 훈련시키고,시알고리즘을적용하는방법과체계가필요하다.
과제해결수단
[21] 본발명의한측면에서,비일시적유형의컴퓨터판독가능매체또는매체들은 하나이상의프로세서에의해실행될때단계를수행하게하는하나이상의명령 시퀀스를포함한다.이단계들은환자에대한하부요로에대한기능검사로부터 얻은데이터를수신하는단계 -하부요로의기능검사로부터얻어진데이터를 하나나그이상의하부요로기능이상과연관짓도록훈련된진단엔진;수신된 데이터로부터하나이상의특징을추출하는단계;하나이상의추출된특징에 기초하여환자의하나나그이상의요역동학적지표들을식별하는단계;하나 이상의식별된요역동학적지표와관련된하나나그이상의하부요로
기능이상의정보를포함하는출력을생성하는단계등이다.
[22] 본발명의다른실시 예에따른하부요로기능이상진단을위한시스템은, 하나나그이상의프로세서와,상기하나이상의프로세서에통신이가능하도록 결합된진단엔진을포함한다.진단엔진은하부요로기능검사들로부터획득된 데이터를하나이상의하부요로기능이상과연관시키도록훈련되어있고아래 단계들을수행하도록구성되어 있다.즉,환자의하부요로기능검사로부터얻은 데이터를수신하는단계와,상기수신된데이터로부터하나나그이상의특징을 추출하는단계와,상기하나나그이상의특징에기초하여환자의하나나그 이상의요역동학적지표를확인하는단계와,하나나그이상의식별된 요역동학적지표들과관련된환자의하나나그이상의하부요로기능이상의 정보를포함한출력을생성하는단계등이다.
발명의효과
[23] 본발명의하부요로기능이상을진단하기위한시스템및방법은,다양한
검사들로부터얻어진많은양의데이터를기반으로훈련된시알고리즘이 적용된것으로써,환자의하부요로기능이상을정확하게특성화할수가있어 의료진이환자의하부요로기능이상을평가하고치료하는것에도움을줄수 있다.
도면의간단한설명
[24] 도 1은본발명의일실시 예에따른하부요로기능이상을진단하기위한 2020/175927 1»（：1^1{2020/002793 시스템및방법에서 비뇨기계의 데이터의 획득을설명하기 위한블록도이다.
[25] 도 2는본발명의시스템및방법에서하부요로계의요역동학데이터를
획득하기 위한요역동학검사를설명하기위한계략도이다.
[26] 도 3은본발명의시스템및방법의 압력측정을설명하기 위한계략도이다.
[27] 도 4및도 5는본발명의시스템및방법에 의한각각 2명의상이한환자에 있어서의요류검사데이터를예시한것이다.
[28] 도 6은본발명의시스템및방법에의한방광충전및배뇨단계에서 얻어진 방광내압측정 데이터를예시한것이다.
[29] 도 7은본발명의시스템및방법에의한저장단계에서 얻어진방광내압측정 데이터를예시한것이다.
[3이 도 8은본발명의시스템및방법에의한주입 및배뇨단계에서 얻어진
방광내압측정 데이터를예시한것이다.
[31] 도 9는본발명의시스템및방법에서충전및배뇨단계중방광내압측정
데이터를예시한것이다.
[32] 도 W은본발명의시스템및방법에서방광내압측정의 배뇨단계동안얻어진 데이터를예시한것이다.
[33] 도 11은본발명의시스템및방법에서요류 (urinary flow rate)의 함수로서
배뇨근압 (detrusor pres sure)의늘롯을나타낸것이다.
[34] 도 12는본발명의시스템및방법에서방광내압측정 (배뇨단계의 데이터가 압력-요류검사에 대응하는경우)으로부터의 예시적인데이터를나타낸것이다.
[35] 도 13은본발명의시스템및방법에서요도단압검사측정동안취해진
예시적인데이터를나타낸것이다.
[36] 도 14는본발명의시스템및방법에서복압성요누출압측정으로부터의
예시적인데이터를나타낸것이다.
[37] 도 15는 ICS (International Continence Society,국제요실금학회)분류에따른 요역동학적 결론의표를나타낸것이다.
[38] 도 16은본발명의시스템및방법의하부요로기능이상진단시스템의
개략도이다.
[39] 도 17은본발명의시스템및방법의 데이터 획득스테이션의 개략도이다.
[4이 도 18은본발명의시스템및방법에서진단엔진을작동시키기 위한예시적인 프로세스를도시한흐름도이다.
[41] 도 19는본발명의시스템및방법의 컴퓨터시스템을도시한것이다.
발명의실시를위한최선의형태
[42] 이하에서는본발명의 이해를돕기위해특정세부사항이설명되나,본발명이 반드시 이러한특정 세부사항에 한정되는것은아니다.
[43] 또한,당업자는후술하는본발명의실시 예에 따른유형의 컴퓨터판독가능한 매체가,프로세스,장치,시스템또는방법과같은다양한방식으로구현될수 2020/175927 1»（：1^1{2020/002793 있음을인식할것이다.
[44] 도면에도시된구성요소는본발명을명확히하기 위해,본발명의실시 예를 도시한것이다.
[45] 본발명의실시 예에 따른구성요소는서브유닛을포함할수있는별도의기능 유닛으로서 설명될수있지만,그구성요소는별도의구성요소로분할될수도 있다.단일시스템또는구성요소에통합된것을포함하여함께통합된다.
[46] 본발명의실시 예에 따른기능또는동작은소프트웨어 ,하드웨어또는이들의 조합에서수행되는부품으로서구현될수있다.
[47] 본발명에서 "연결된”또는”통신적으로연결된”이라는용어는직접 연결,하나 이상의중개장치를통한간접 연결및무선연결을포함한다.
[48] 본발명에서특정단계는선택적으로수행되거나,특정순서로수행이
제한되지 않으며 ,다른단계와동시에수행될수있다.
[49] 본발명에서 "일실시 예”, "바람직한실시 예”대한언급은실시 예와관련하여 설명된특정특징,구조,특성또는기능이 적어도포함된다는것을의미한다.본 발명의 일실시 예는하나이상일수있다.
[5이 본발명에서 ”일실시 예에서”또는 "실시 예에
[51] 서”의 기재는모두반드시동일한실시 예를지칭하는것은아니다.
[52] 도 1은본발명의 일실시 예에따른하부요로기능이상을진단하기위한
시스템의 비뇨기계의 데이터의 획득을설명하기 위한블록도이다.
[53] 도 1을참조하면,인공지능 (AI, 192)은요역동학적 결론을도출하기 위해단일 또는복수의하부요로기능이상을갖는환자의특정하부요로기능이상의 본질을특징지을수있다.
[54] 인공지능 (192)은기본임상데이터 (180)및투시법의요역동학검사결과 (186)를 포함하는데이터를사용할수있다.
[55] 실시 예에서,투시법의요역동학검사결과 (186)는요역동학검사결과 (187,여러 하위 세부검사포함)및 엑스선투시 데이터 (188)일수있다.
[56] 실시 예에서,인공지능 (192)은결과를해석하기 전에,투시법의요역동학검사 결과 (186)에서 에러 (errors)를자동으로검출하고스크리닝하여,스크리닝된 에러 (errors)를제거할수있다.
[57] 실시 예에서,검출된에러 (errors)는특정환자의요역동학적결론 (193)에
추가사항으로부록으로열거될수있다.
[58] 실시 예에서,기본임상데이터 (180)는다양한환자임상데이터를포함할수 있다.예컨대,기본임상데이터 (180)는환자인구통계,환자병력,체계적인 문헌고찰및신체검사에의해 획득된데이터 (181)와,설문지,배뇨일지 및 잔뇨량 (PVR, post-void residual urine volume)데이터 (182)와,검사실검사
(laboratory test;혈액검사및소변분석검사등과같은진단검사를말함) 결과 (183)와,영상진단검사로얻어진데이터 (184)와내시경검사데이터 (185)를 포함할수있다. 2020/175927 1»（：1/10公020/002793
[59] 실시예에서,환자인구통계는성별,연령,신장,체중,체질량지수,복부둘레 등을포함할수있다.
[6이 실시예들에서,환자의학적이력은과거의검진또는수술이력,약물이력및 현재복용약물을포함할수있다.
[61] 실시예들에서,환자의의학적이력은모든이전신경질환,특히하부요로
기능에크게영향을줄수있는뇌,척수,척추,비뇨생식기또는골반강에서의 이전수술이력을포함할수있다.
[62] 실시예에서,체계적검토로부터획득된데이터는발기기능및장기능을
포함할수있다.
[63] 실시예에서,신체검사로부터의정보는몸통,사지,하복부 (lower abdomen), 비뇨생식기영역또는전립선 (전립선비대증의존재또는부재,요실금으로인한 비뇨생식기피부습진또는천골피부결함)의운동또는감각기능을포함하고, 특히 ,집중신경학적검사 (focused neurological examnination)일수있다.
[64] 실시예에서,집중된신경학적검사로부터의결과는,가벼운촉각검사 (light touch test)및/또는바늘통각검사 (pinprick test)에대한회음부감각 (perineal sensation),항문근육긴장도 (anal tone)정도,구해면체반사 (bulbocavemosus reflex)의존재또는부재 ,항문괄약근 (anal sphincter)의수의적인수죽 (voluntary contraction),및대변막힘 (fecal impaction)을포함할수있다.
[65] 실시예에서 ,설문지는하부요로증상 (lower urinary tract symptom)과관련된 구조화된설문에대한환자의응답을포함할수있다.설문지는하부요로증상의 중증도 (severity)와특정환자의삶의질 (quality of life)에미치는영향을평가할 수있기때문에환자의주관적증상을정량화하는데매우중요한도구이다.
[66] 실시예에서,배뇨일지또는배뇨횟수-배뇨량일지 (frequency-volume chart) 로부터획득된정량적정보는주간또는야간시간동안의배뇨빈도,배뇨간격 , 요실금의횟수,평균또는최대배뇨량을포함할수있다.
[67] 실시예에서,잔뇨량 (PVR)은초음파장치또는도뇨 (urethral catheterization)에 의해평가될수있다.실시예에서,검사실검사에는소변미생물의배양,신장 기능부족정도를나타내는혈청크레아티닌수치 (serum creatinine level)를 포함할수있다.
[68] 실시예에서,요로의해부학적평가는신장및방광의영상화검사를포함할수 있다.요로 CT및또는초음파영상은손상된신장,또는방광의육주화 (bladder trabeculation)정도를보여줄수있다.방광육주화는하부요로기능이상에 속발한방광벽의보상성비후 (compensatory hypertrophy)를암시하는소견이다.
[69] 실시예에서,방광및요도의내시경검사는요도협착의유무,남성의전립선 비대에의한해부학적방광출구폐색의유무,방광경부기능부실 (bladder neck incompetence)의유무,방광요관역류 (vesicoureteral mflux)를암시하는두요관구 (ureteral orifice)의형태및방광육주화정도를식별할수있다.
[7이 이하, 1기본환자데이터 (baseline patient data)、 자임상데이터 (patient 2020/175927 1»（：1^1{2020/002793 clinical data)'또는 '기본임상데이터 (baseline clinical data)'라는용어는상술한 환자데이터,및요역동학검사가아닌다른출처들에서얻은임상정보를 통칭한다.
1] 일반적으로,요역동학검사에서획득된데이터는몇가지오류또는아티팩트를 포함할수있다.그리고이러한오류가빠르고정확하게수정되지않으면잘못된 해석으로이어질수있다.
2] 본발명은사전에축적된방대한양의검사데이터를사용하여학습될수있고 이들에러를자동검출하는기능을갖는인공지능 (192)알고리즘 (algorithm)을 포함할수있다.
[73] 인공지능 (192)알고리즘 (algorithm)은미리피할수있는일부에러를검출하고, 검사후에미리피할수없는다른에러를정확하게인식하고인식된에러에 대한대책을제안할수있다.
[74] 실시예들에서,인공지능 (192)알고리즘 (algorithm)이검출할수있는에러중 일부는다음과같다.
[75] 요류검사중의오류또는아티팩트 (artifact)는,웨그아티팩트 (wag artifact), 고르지않는배뇨에의한아티팩트 (artifact),복부긴장,요류검사중의변실금 인공노이즈신호가포함될수있다.
[76] 실시예에서 ,충전기방광내압측정중오류또는아티팩트 (artifact)는,초기
휴지기압력 (initial resting pressure),복압 (Pabd)라인의기포,방광내압 (Pves) 라인의기포,튜빙시스템의기포,반복되는충전,환자위치,충전속도,장가스, 직장수축,직장수축에의한동시에변화되는방광내압,복부호흡,자발적인 골반근육수죽,불수의적배뇨근수죽 (involuntary detrusor contraction) 합겨] , 과소평가된방광유순도 (bladder compliance),충전된방광용적의추정에영향을 미치는이뇨 (diuresis)를포함할수있다.
[77] 실시예에서,압력-요류검사 (pressure-flow study)중오류또는
아티팩트 (artifact)는배줄된 Pves카테터 (catheter),방광점막표면에닿은 Pves 카테터구멍,직장수축,배뇨욕구,자발적인골반근육수축,배뇨지시전 불수의적배뇨근수죽,배뇨에서복압저하,배뇨근후수죽 (after-contraction), 요류에서웨그아티팩트 (wag artifact),혈괴 (blood clot)에의해카테터막힘을 포함할수있다.
[78] 실시예에서 ,복압성요누출압측정중오류또는아티팩트 (artifact)는불수의적 배뇨근수축, Pves카테터미끄러져빠짐 ,복압 (Pabd)의감쇠 , Pabd카테터의직장 내로의미끄러짐,골반저근 (pelvic muscle)이완및카테터자체로인한과대 평가를포함한다.
9] 실시예에서 ,배뇨근요누출압측정중오류또는아티팩트 (artifact)는불수의적 배뇨근수축및방광요관역류에의한과소평가를포함한다.
[8이 실시예에서,골반근육 EMG중오류또는아티팩트 (artifact)는충전기,전자기 간섭,약한신호,방광충전중배뇨충동,방광충전중에딸꾹질,충전기 2020/175927 1»（：1^1{2020/002793 방광내압즉정에영향을미치는보호반사 (guarding reflex),배뇨전골반근육의 습관적수축,하지마비,하체경직을포함한다.
[81] 실시예에서 ,요도내압곡선중오류또는아티팩트 (artifact)는자발적인
골반저근수축,낮은주입압력,불수의적배뇨근수축및과도하게긴기능적 프로파일길이등을포함한다.
[82] 실시예에서 ,투시모니터링중오류또는아티팩트 (artifact)는방광경부와
치골결합의오버랩핑 (overlapping)및이미지획득시부적절한타이밍을 포함한다.
[83] 실시예에서,본발명은 (1)환자의기본임상데이터에기초하여수행될
요역동학검사의세부적인하위테스트항목들을결정하고, (2)요역동학검사를 수행하는동안오류를자동검출하고아티팩트 (artifact)리스트를만들며, (3) 요역동학검사를수행하는동안요역동학검사의결과를도출하기위해자동으로 상세한결과를선택하고, (4)기존의요역동학적결론과더불어요역동학검사를 수행하는동안획득된다른주요결과를나열하고, (5)하부요로기능이상의특정 특성이특징적인경우,향후하부요로기능이상이장차신장손상을야기할위험 요소를예측할수있다.
[84] 실시예에서,상기항목 (3)은방광경부기능부실유무,충전기동안
방광요관역류,충전기동안방광의육주화,배뇨단계동안방광요관역류,배뇨 단계동안의전립선내역류,배뇨단계동안방광경부또는요도괄약근의거동 및배뇨후단계에서의잔뇨량에관한하나이상의정보를포함할수있다.
[85] 도 2는본발명의시스템및방법에서하부요로계의요역동학적데이터를
획득하기위한요역동학검사를설명하기위한계략도이다.
[86] 도 2를참조하면,본발명의하부요로기능이상을진단하기위한시스템 (100)은 환자의요도를통해방광 (108)에삽입되는요도카테터 (124)와,복부내압력 측정을위해직장 (112)에삽입되는직장풍선 (122)와,요도괄약근또는 골반근육에의해생성된전기활동을나타내는근전도 (EMG)신호를측정하기 위해항문 (또는요도괄약근또는골반근육)주위에부착된하나이상의 전극 (120a및 120b)과,이미징장치 (130)와,용기 (126)내의 액체의용량 (또는 중량)를즉정하기위한용량센서 (128예컨대,체중계)와,이들구성과
전기적으로연결되어이들구성으로부터신호를처리하고이들구성을 제어하는컴퓨터 (132)를포함한다.
[87] 실시예에서,전극 (120a)은요도괄약근의활동을측정하기위해항문괄약근에 삽입된바늘전극또는요도에삽입된요도내전극일수있다.
[88] 도 3은본발명의시스템및방법의압력측정을설명하기위한계략도이다.
[89] 도 3을참조하면,실시예에서,직장카테터 (122)및요도카테터 (124)는액체로 채워진카테터일수있으며,외부압력변환기 (142및 140)는카테터 (122및 124) 끝단 (tip)에서의압력을각각측정한다.압력변환기 (142)에의해측정된 압력 (Pabd)및압력변환기 (140)에의해측정된압력 (Pves)은컴퓨터 (132)에 2020/175927 1»（：1/10公020/002793 입력될수있다.
도 3을참조하면,실시예에서,각각의압력변환기 (140및 142)는스톱콕에 연결된다.스톱콕이열리면액체메니스커스 (fluid meniscus)가형성되고압력 변환기의압력이대기압으로설정된다.그리고,스톱콕의높이는치골결합의 상단 (153)으로설정될수있고, Pves및 Pabd는 0으로설정될수있다.이 프로세스를 "제로화”라고할수있고,이는도 2내지도 3의시스템에서 수행된다.
실시예에서,카테터 (122, 124)의압력센서는와이파이또는블루투스와같은 무선채널을통신할수있다.실시 예에서,센서는 MEMS디바이스일수있고 카테터의끝단근처에설치될수있다.
실시예들에서,용기 (126)는환자에의해배뇨된액체를수집할수있고,볼륨 센서 (128)는용기 (126)내에서측정된액체의중량을전기신호로변환하고무선 채널또는와이어를통해전기신호를컴퓨터 (132)에전달할수있다.
[93] 실시예에서,배뇨량 (voided volume)으로부터요속 (flow rate)이계산되거나그 반대인경우도있기때문에,배뇨량과요속은상호의존적이다.
실시예에서,볼륨센서 (128)대신에다른유형의측정장치가사용될수있다.
[95] 예를들어 ,로드셀 (load cell, gravimetric)또는회전디스크방법이배뇨량과 요속을측정하기위해사용될수있다.
다른예에서,용량기술을사용하는딥스틱방법은용기 (126)의소변깊이를 측정하기위해사용될수있다.
[97] 또다른예에서,방울분광법 (drop spectrometry )은요도구 (urethral meatus)에서 배출된소변방울의비율을계수함으로써요속을결정하는데사용될수있다.
[98] 실시예에서,볼륨센서 (128)로부터의전기신호는유선또는무선통신채널을 스 통해전송되고환자의요속,요속곡선패턴및종배뇨량 (total voided volume)을
021
결정하도록처리될수있다.
실시예에서,다양한유형의이미징장치 (130)가사용될수있다.예를들어, 이미징장치 (130)는환자의방광 (108)및요도와같은내부장기의이미지를 캡처하기위한엑스선투시모니터링시스템일수있다.
00] 실시예에서 ,요도카테터 (124)를통해조영제가혼합된액체가방광 (108)에 주입된후,엑스선에의해생성된투시영상은요실금,방광또는요도의 해부학적이상,신장으로의역류,방광에남아있는잔뇨량의존재등과같은 하부요로기능이상을진단하기위해포착및분석될수있다.
이하에서는의료진이다양한시험동안액체를방광으로주입할수있기 때문에,소변및액체라는용어는상호교환적으로사용될수있다.
실시예에서,환자또는환자의간병인은휴대폰또는 PDA와같은모바일 장치 (133)를사용하여기본임상데이터 (baseline clinical data) (180)또는임상 정보를컴퓨터 (132)에제공할수있다.
03] 예를들어,모바일장치 (133)는환자기본임상데이터를컴퓨터 (132)로전송할 2020/175927 1»（：1^1{2020/002793 수있다.
[104] 상술한바와같이,기본임상데이터 (180)라는용어는환자인구통계 (성,연령, 신장,체중,체질량지수,복부둘레),병력 (신경계질환포함,뇌,척수,척주, 비뇨생식기또는골반강에서의이전수술병력포함),현재약물치료,전신 검토 (발기기능,장기능,하부요로증상포함),신체검사 (몸통의운동또는감각 기능,팔다리 ,하복부또는전립선포함),환자의회음부,항문및비뇨생식기 계통에대한집중된신경학적검사,배뇨주기와배뇨량을보여주는
배뇨일지로부터의지표,하부요로증상설문지에대한응답을지칭하지만이에 제한되지는않는다.
[105] 이하,환자데이터라는용어는위에서언급한기본임상데이터 (180)및
요역동학검사로부터얻어진임상정보를총괄적으로지칭한다.
[106] 실시예에서,시스템 (100)의센서대신에다양한유형의센서가사용될수있다. 예를들어,볼륨센서 (128)대신에요속을측정하기위해레이저가사용될수 있다.
[107] 다른예에서,압력방광내부는환자의복부피부에적용되는근적외선
분광법 (NIRS)기술에의해직접또는간접적으로측정될수있다.체적
센서 (128)는레이저와같은다른유형의센서로대체될수있다.
[108] 환자의하부요로기능이상을진단하기위해,의료진은하부요로기능이상에 대한다양한테스트를수행할수있다.
[109] 이하,요역동학검사라는용어는요류측정술,방광내압측정,요도단압검사
(urethral pressure profile)및요누줄압즉정등의환자의하부요로기능이상을 특성화하기위해수행되는하위세부테스트들을총칭한다.
[110] 실시예에서,의료진은환자가기립또는앉은자세로배치된상태에서
요속뿐만아니라배뇨량의총량을측정하기위해요류검사 (uroflowmetry)를 수행할수있다.
[111] 도 4및도 5는본발명의시스템및방법에의한각각 2명의상이한환자에
대한요류검사의예시적인데이터를나타낸것이다.
[112] 도 4를참조하면,플롯 (210)은시간의함수로서컨테이너 (126)에의해수집된 소변의용량을나타낼수있다.
[113] 실시예에서,플롯 (2W)은정체기 (plateau)에도달할수있는데,이는정상배뇨 기능을갖는제 1환자에서총배뇨량을나타낼수있다.
[114] 실시예에서 ,플롯 (220)은제 1환자에서의요속을나타낼수있다.
[115] 실시예에서,플롯 (210및 220)은볼륨센서 (128)로부터의신호를처리함으로써 얻어질수있다.
[116] 도 5를참조하면,요류검사 (uroflowmetry),보다구체적으로,요류-근전도검사 (flow-EMG)로부터나오는데이터인데，이데이터는 EMG센서 (120a,
120b)로부터나오는 EMG신호의플롯 (230),요속을나타내는플롯 (240)및양성 전립선비대증과같은방광줄구폐색 (bladder outlet obstruction)이 있는두번째 2020/175927 1»（：1^1{2020/002793 환자에 의해배뇨된소변양을나타내는플롯 (250)을포함한다.
[117] 실시 예에서,플롯 (240및 250)은볼륨센서 (128)로부터의신호를처리함으로써 획득될수있다.
[118] 실시 예에서,요류-근전도검사는배뇨중환자의 배뇨패턴이요도괄약근
활성과관련있는지 결정하기위해수행될수있다.
[119] 실시 예들에서, EMG신호의플롯 (230)은요도괄약근활동을판단하기 위해 사용될수있다.
[120] 일반적으로방광기능은요도괄약근활동과조화가이루어져야한다 (협동적 작용, synergic).방광을비우기위해방광이수축하면 (요류가나타나면) 요도괄약근은이완되어야한다 (요도괄약근의 EMG활동감소).
[121] 일반적으로,건강한사람은소변저장단계동안에는요도괄약근의 정상적인 활성이 나타나고,배뇨가시작되기 직전에요도괄약근의 활동이감소하며, 배뇨가완료된후요도괄약근활동은정상화된다.
[122] 대조적으로,관련신경계질환으로인해요도괄약근활성이고정된환자는
배뇨단계동안요도괄약근을자동으로이완시킬수없다 (따라서,요도괄약근의 EMG활성감소가없음).
[123] 마찬가지로,특정척수손상또는척수질환과같은관련신경계장애가있는 환자의 경우,배뇨단계동안의요도괄약근의 활동증가또는배뇨근-괄약근 협동장애 (detrusor-sphincter dyssynergia)가관찰될수있다.
[124] 요도괄약근활성의 이상은플롯 (230)을분석함으로써 결정될수있다.
[125] 늘롯 (220)에도시된바와같이 ,요속은최고요속 (maximum flow rate, Qmax,
222)으로나타내어질수있고,배뇨시간 (224)은환자가배뇨에 걸린시간을 나타낼수있다.
[126] 대조적으로,요류 (240)는다수의국소최대값 (242, 244및 246)을가질수있다. 실시 예에서，플롯 (250)은제 2환자가배뇨한소변의총량을나타내는정체기에 도달할수있다.
[127] 또한,실시 예에서 ,주저시간 (225)(플롯 (250)에도시 됨 )은검사의시작지점과 배뇨의시작지점사이의시간간격을나타낼수있다.
[128] 실시 예에서,요역동학검사후,의료진은방광에남아있는잔뇨량을측정할수 있다.
[129] 실시 예에서,잔뇨량을정량적으로측정하기 위해,의료진은 (1)방광으로부터 소변을배출하기위한요도카테터 (124), (2)휴대용초음파방광스캐너,또는 (3) 종래의초음파장치를사용할수있다.
[130] 대안적으로,의료진은투시 엑스선 (130)을사용하여잔뇨량을정성적으로
산출할수있다.
[131] 실시 예에서,플롯 (210, 220, 230, 240및 250)의 여러특징들은요역동학적
결론을획득하거나,환자의하부요로기능이상을식별하기 위한지표로사용될 수있다. 2020/175927 1»（：1^1{2020/002793
[132] 실시 예에서，특징은최고요속 (222, 242),배뇨시간 (224),주저시간 (225),요속 곡선패턴 (예컨대,요류검사계량도 (220또는 240)에서의 피크수 (242-246)와 같은것들을포함함),총배뇨량및잔뇨량을포함할수있다.
[133] 실시 예들에서,요속곡선패턴 (220또는 240)은일반적인종형패턴,탑형슈퍼 플로우패턴,압축패턴,고원형수축패턴,단속형 패턴,간헐적스트레인요류 패턴,스타카토모양의패턴으로구분될수있다.
[134] 예컨대,제 2환자의 예에서는요속곡선 (240)이중단된형상이기 때문에
간헐성을갖는것으로결론지을수있다.
[135] 다른예에서,배뇨시간 (224)이 정상범위 내에 있는경우,제 1환자의 배뇨근 기능이 정상일가능성이 있다고제안될수있다.
[136] 또다른예에서,최고요속 (220)이 너무높거나 (또는너무낮음)배뇨
시간 (224)이너무짧거나 (또는너무긴경우),환자가수퍼플로우 (또는폐색) 패턴을갖는것이 제안될수있다.
[137] 방광 (108)은배뇨근이 이완되고충만되어소변이 저장되고,소변을비우기
위해 배뇨단계동안배뇨근이수축되도록되어 있다.
[138] 실시 예에서,의료진은방광내압측정 (또는같은의미로서 cystometrogram)을 시행할수있는데,이는방광의 저장 (315,충전, filling)및배뇨 (31,배출, emptying)단계동안있을수있는기능이상을조사하기 위해 행해지는
요역동학검사의중요한부분이다.
[139] 도 6은본발명의시스템및방법에의한충전및배뇨단계에서 얻어진
방광내압측정의 예시적인데이터를나타낸것이다.
[14이 실시 예에서 ,플롯 (311)은방광내압측정동안측정된배뇨근압 (Pdet, detrusor pressure) (350)을도시하는데,배뇨근압 (350)은방광내압 (방광내의 압력, Pves, intravesical pressure)(330)에서복압 (Pabd, abdominal pressure)을차감한압력이다.
[141] 실시 예에서 ,방광내압측정은의료진이요도카테터 (124,충전기방광내압 측정)를사용하여방광을액체로채울수있는저장 (또는충전)단계 (315);및 환자가방광을비울수있는배뇨단계 (316) (배뇨기방광내압검사, voiding cystometry또는동일한의미로압력-요류검사, pressure-flow study)등두단계를 포함할수있다.
[142] 실시 예에서,방광내부의 압력인방광내압 (330, Pves)은요도카테터 (124)에 연결된압력 센서 (140)에의해측정될수있다.
[143] 실시 예에서,복압 (340, Pabd)은직장카테터 (122)에 연결된압력 센서 (142)에 의해측정될수있다.
[144] 실시 예에서,충전단계 (315)동안의료진은요도카테터 (124)를통해 일정한 속도로액체로방광 (108)에채울수있다.
[145] 플롯 (311)에도시된바와같이환자가소변을보려는강한배뇨욕구 (strong desire to void)를느끼는시점 (312)에서 배뇨지시가있을때까지，모산라는낮고 안정적으로유지될수있다. 2020/175927 1»（：1^1{2020/002793
[146] 환자가강한배뇨욕구를느끼는시점 (312)에서,소변을비우기시작하도록 환자의 배뇨근이수축하기 때문에 Pdet는빠르게증가할수있다.
[147] 실시 예들에서,배뇨단계 (316)동안의방광내압측정은압력-요류검사 (또는 동일한의미로배뇨기 방광내압검사)로지칭될수있다.
[148] 도 7은본발명의시스템및방법에의한저장단계에서 얻어진방광내압
측정의 예시적인데이터를나타낸것이다.
[149] 도 7을참조하면,플롯 (320)은요도카테터 (124)를통해방광에 채워진액체의 양 (즉,주입된용량, infused volume, Vinf)을도시하며，여기서 액체는저장단계 동안일정한속도로채워질수있다.
[150] 플롯 (330, 340및 350)은각각 Pves, Pabd및 Pdet를나타내고,플롯 (360)은
센서 (120a및 120b)로부터의 EMG신호를나타낸다.여기서,플롯 (350)은도 6의 저장단계 (315)에 대응되는것이다.
[151] 충전기방광내압측정에서,가로축은시간에 해당한다.충전기방광내압측정 동안방광이 일정한속도로충전되기 때문에,시간은결국충전량을반영한다.
[152] 전형적으로, stress maneuver인기침은복압의순간적인증가를유도하기위해 사용될수있다.
[153] 실시 예에서,의료진은환자에게몇차례기침을지시할수있으며,이때 Pves 및 Pabd는동일한압력진폭의 각기침에서동시에날카로운피크 (322및 332)를 나타낸다.
[154] Pdet(350)는 Pabd(340)에 의해감산된 Pves(330)의 압력이기 때문에，이러한 피크는 Pdet의플롯 (350)에 나타나지 않는다 (Pves(330)및 Pabd(340)의피크의 진폭이동일할수있기 때문이다.).
[155] 실시 예에서, EMG신호 (360)는플롯 (320, 330및 340)에서골반근육또는
요도괄약근의 반사활성화로인한 EMG활성의증가를나타낼수있다.
[156] 실시 예들에서,의료진은신체로부터 압력 센서로의 적절한압력 전달을
보장하기 위해배뇨단계전후에환자에게기침을지시할수있다 (즉,기침은 측정장비의품질관리를위해사용될수있다).
[157] 실시 예에서,의료진은충전기방광내압측정으로부터 데이터를분석하여방광 유순도 (bladder compliance),방광감각,방광용량,배뇨근기능및요도기능에 대한중요한정보를얻을수있다.
[158] 방광유순도는방광에충전된액체의단위용량당 Pdet의증가로정의된다.
[159] 보관단계에서 방광유순도는보통,낮음또는높음으로분류될수있다.
[160] 정상적인유순도를가진방광은 Pdet(350)의증가가거의 없이큰용적까지 채워질수있다.
[161] 그러나,유순도가낮은방광은척수손상또는척수질환과같은다양한신경계 장애로인해발생하는데,이러한질환들은방광벽 내의탄성감소,방광벽의 섬유증,또는두가지모두의 이상을초래한다.
[162] 이러한방광벽 탄성의감소는방광내압측정의 저장단계동안점진적인압력 2020/175927 1»（：1^1{2020/002793 증가로수용력상실에반영될수있다.
[163] 도 8은본발명의시스템및방법에의한주입및배뇨단계에서얻어진
방광내압측정의예시적인데이터를나타낸것이다.
[164] 실시예들에서,도 6의플롯 (311)(또는도 8의플롯 (3기및 376))의저장
단계 (315)는두플롯 (1라의플롯 (350)과도 7의방광에채워진액체의양 (320)의 플롯)을사용하여생성될수있다.
[165] 플롯 (3기)에도시된바와같이,유순도가높은방광 (372)에서는환자가배뇨를 시작할시점 (373)까지 Pdet가크게증가하지않을수있다.
[166] 이에비해 ,저유순도방광 (374)에서는액체를채우는초기단계에서 Pdet가
크게증가할수있다.즉,방광의충전용적이소량에도달하더라도방광내압 곡선 (376)의기울기가급격히증가한다.
[167] 실시예에서,도 6내지도 3c의특징들은방광유순도 (bladder compliance)을
식별하는데사용될수있으며,여기서특징들은곡선 (376)의기울기를포함할수 있다.
[168] 실시예들에서,저장 (중전)단계동안방광감각 (bladder sensation)도기록될수 있다.
[169] 충전 (또는저장)단계 (315)동안방광이 액체로채워질때,의료진은환자에게 방광충만정도에따른감각을보고하도록요청할수있다.
[17이 실시예에서,환자의보고에기초하여의료진은환자의첫충전감각 (first
sensation of filling),첫배뇨욕구 (first desire to void),및강한배뇨욕구 (strong desire to void)를가질때충전액체의양을파악하고기록할수있다.
[171] 이러한방광감각정보에기초하여 ,의료진은방광과민 (bladder oversensitivity), 방광감각감소 (reduced bladder sensation),방광감각부재 (absent bladder sensation),비정상적방광감각 (abnormal sensation),비특이적방광인식
(non-specific bladder awareness)및방광통증 (bladder pain)등으로환자의 방광감각을분류할수있다.
[172] 도식목적으로나타내자면,정상적인방광감각을가진경우,방광에채워진 액체의용량이통상약 400또는 500 mL에도달할때강한배뇨욕구 (strong desire to void)를느끼게된다.
[173] 그러나,방광감각이감소된환자는방광용량이예를들어약 400mL에도달할 때첫중전감각 (first sensation of filling)을느낄수있다.
[174] 실시예에서,의료진은충전기방광내압측정으로부터의데이터를분석하여 환자의방광의배뇨근과활동성 (detrusor overactivity)과같은배뇨근활동을 특성화할수있다.
[175] 배뇨근과활동성은저장단계에서자발적이거나유발될수있는불수의적
배뇨근수죽 (involuntary detrusor contraction)을특징으로하는요역동학적관찰로 정의된다.
[176] 도 9는본발명의시스템및방법에서충전및배뇨단계중방광내압 2020/175927 1»（：1^1{2020/002793 측정으로부터의 예시적인데이터를나타낸것이다.
[177] 도시된바와같이 ,플롯 (410, 420및 430)은각각방광 (412, 422및 432)의
배뇨근압 (Pdet)을나타낸다.
[178] 정상적인방광 (412)과비교하여 ,과활동성 방광 (overactive bladder)(422,
432)에서는저장단계동안배뇨지시 없이불수의적 배뇨근수축 (420, 430, 434, 436)이 발생될수있는데,여기서불수의적 배뇨근수축은저절로일어날수도, 또는여러종류의자극에의해유발되어나타날수도있다.
[179] 실시 예들에서 ,저장단계동안불수의적 배뇨근수축 (420, 430, 434, 436)은 배뇨근과활동성을나타낼수있다.
[180] 또한,일반방광 (412)와비교하여 ,방광 (422, 432)에서는저장단계의초기동안 하나나그이상의 위상성수죽 (phasic contraction, 434및 436)을나타낼수있다.
[181] 실시 예에서,도 9의플롯은요역동학적지표를식별하고요역동학적 결론을 얻는데사용될수있다.
[182] 저장단계의초기에서불수의적 배뇨근수축이발생할때환자는위상성
불수의적 배뇨근수죽 (phasic involuntary detrusor contraction) (434, 436)을 갖는다고결론지을수있다.
[183] 또한저장단계의마지막단계에서불수의적 배뇨근수축이발생할때환자는 말기불수의적 배뇨근수죽 (terminal involuntary detrusor contraction) (420, 430)을 갖는다고결론지을수있다.
[184] 환자가저장단계동안,위상성불수의적 배뇨근수축 (434, 436)또는말기
불수의적 배뇨근수축 (420, 430)중어느하나이상을갖는경우에,환자는 배뇨근과활동성 (detrusor overactivity)을갖는것으로결론지을수있다.
[185] 실시 예들에서 ,방광용량 (bladder capacity)은충전기 방광내압측정에 의해 결정될수있다.
[186] 방광용량은충전기 방광내압측정종료시 방광용량이다.실시 예에서,
의료진은‘강한절박뇨 (strong urgency)’와같은종료사유를보고할수있다.
[187] 최대방광압용량 (maximum cystometric capacity)은정상적인방광감각을가진 환자가강한배뇨욕구 (strong desire to void)를나타내는양이다.
[188] 실시 예들에서,충전단계동안장치 (130)로부터의 엑스선투시영상은
방광경부기능부실 (incompetent bladder neck),전립선비대,방광요관역류, 육주화형성,방광게실 (bladder diverticulum),수죽방광및요누줄 (urine leakage)을결정하기위해분석될수있다.
[189] 배뇨단계동안,장치 (130)로부터의 엑스선투시영상은방광수축시
방광요관역류,전립선내 역류,배뇨근-괄약근협동장애,남성에서요류의폐색 위치를보여줄수있다.
[190] 또한,배뇨후기간에장치 (130)로부터의 엑스선투시영상은많은양의
잔뇨량을정성적으로나타낼수있다.장치 (130)로부터의 엑스선투시영상은 복압성요누출압측정동안소변누출을나타낼수있다. 2020/175927 1»（：1^1{2020/002793
[191] 실시예에서,요도기능은충전기방광내압측정중에결정될수있다.
[192] 저장 (또는충전)단계 (315)에서,요도기능은 « 의표준화된분류체계에
의거하여정상또는요도닫김기능부실 (incompetent urethral closure
mechanism)로분류될수있다.
[193] 정상적인요도닫김기능을갖는방광은복압이갑자기증가하더라도복압성 요누출이없을수있지만,저장단계에서배뇨근과활동성으로인해누출이 발생할수있다.방광수축이없는상태에서소변누출이발생하면요도닫김 기능부실이 있는것으로분류될수있다.
[194] 요역동학복압성요실금은방광수축이없는상태에서복압이증가할때
발생하는비자발적소변누출로정의된다.
[195] 일반적으로, ICS는정상또는요도닫김기능부실을분류하기위해수행할
검사의종류또는적용할절단치 (cutoff value)를지정한정량적기준을제공하지 않는다.
[196] 요도닫김기능의유형을결정하기위해요도단압검사 (Urethral Pressure Profile, UPP)또는복압성요누출압중어느것이측정되어야하는지에대한지침이없기 때문에,의료진은자신의임상경험에기초하여요도닫김기능을판단하여야 한다.
[197] 실시예에서,저장단계 (315)에서요도기능을파악하기위해의료진은환자의 병력,신체검사및똑바로선자세에서복압성요누출압및투시영상에의해 평가된방광경부상태에기초하여임상적판단을내릴수있다.
[198] 실시예에서,의료진은판단시엑스선투시법으로하부방광에서열린
방광경부를확인할수있다.
[199] 실시예들에서 ,배뇨근요누줄압 (detrusor leak point pressure, DLPP)는중전기 방광내압측정동안측정될수있다.
[200] 배뇨근요누출압은방광충전단계 (315)동안카테터주위에서누출이발견되는 최저방광내압으로정의된다.
[201] 배뇨근요누줄압은신경인성방광 (neurogenic bladder)환자에서상부요로계 손상을유발할수있는’’고압방광 (high pressure bladder)’’을감지하는지표이다.
[202] 배뇨근요누출압을측정하기위해환자를앙와위 (supine position)자세로누인 후방광을비운다.방광은 5, 10또는 60 mL/분과같은미리정해진충전속도로 채워지며,환자는긴장을풀고방광수축을억제하지않으며충전단계동안 누출을의도적으로억제하지는말아야한다.
[203] 배뇨근요누출압은배뇨근수축또는복압증가가없을때소변누출이발생하는 압력으로정의될수있다.
[204] 누줄은엑스레이투시법또는외요도구 (external urethral meatus)부위에소변이 나오는지직접시각적으로관찰함으로써감지할수있다.일반적으로측정된 지표는 Pves (330)이다.
[205] 실시예에서 ,신경인성방광환자의경우, 40 cmH20초과의배뇨근요누출압은 2020/175927 1»（：1^1{2020/002793 향후상부요로계에손상이 일어날수있는고위험 인자로간주될수있다.
[206] 실시 예에서 ,방광유순도가열악한환자의경우,배뇨근요누출압은상부요로 손상의 예측지표로서사용될수있다.
[207] 실시 예에서,측정된배뇨근요누출압은의료진이요역동학적결론을내릴때 고려될수있다.
[208] 도 W은본발명의시스템및방법에서방광내압측정의 배뇨단계동안얻어진 예시적인데이터를나타낸것이다.
[209] 도시된바와같이,플롯 (510, 520및 530)은배뇨단계동안측정된
방광내압측정 (압력-요류검사) (316)의 Pves, Pabd및모산 를각각나타내고, 플롯 (540)은센서 (120a또는 120b)로부터의 EMG신호를나타낸다.
[210] 실시 예에서, EMG신호 (540)는요도괄약근활성을검출하고,요류가
요도괄약근과협동적또는비협동적인지를결정하는데사용될수있다 (즉, 배뇨근-괄약근협동장애인지결정함).
[211] 요류-근전도 (flow-EMG)검사에서 위에서설명한바와같이,건강한사람은
방광이 채워짐에따라요도괄약근의활동이증가하고,배뇨가시작되기 직전에 요도괄약근의 활동이감소하고,배뇨가끝난후요도괄약근의활동을재개할수 있다.
[212] 대조적으로,특정신경계장애로인해괄약근활동이고정된환자는배뇨단계 동안요도괄약근의활동을감소시키지못할수있다.
[213] 유사하게,특정신경계장애로인한배뇨근-괄약근협동장애를갖는환자는 배뇨단계동안요도괄약근의활동이증가될수있다.
[214] 근전도검사 (540)에 에러 및/또는아티팩트 (artifact)가나타날수있기 때문에, 방광경부및외요도괄약근 (external urethral sphincter)의 개방여부를파악하기 위해 배뇨직전및배뇨직후에방광경부및외요도괄약근에 엑스선이미지를 획득하여근전도에독립적이고도보조적인소견을얻어판단할수있다.
[215] 실시 예들에서,플롯 (550)은요류측정,즉소변의요속 (Qura)를보여주고있다. 여기서플롯 (550)은볼륨센서 (128)로부터 데이터를처리함으로써 획득될수 있다.
[216] 실시 예에서,배뇨단계직전및직후에,의료진은환자에게기침 (562, 564)을 하라고지시할수있다.
[217] 또한,상술한바와같이,의료진은신체로부터 압력 센서로의 적절한압력
전달을보장하기위해 배뇨전후에환자에게기침을지시할수있다 (즉,기침은 측정장비의품질관리를위해사용될수있다).
[218] 실시 예에서, Pves(562, 564)및 Pabd(566, 567)의급격한피크는전체복압의 급격한증가에 대한압력반응에 해당한다.
[219] 실시 예들에서,시점 (552)에서요류가출현하기시작하고,시점 (556)에서
요류가종료된다.요속은시점 (554)에서최대값 (최고요속)을갖는다.
[22이 실시 예들에서 ,시점 (532및 534)은각각배뇨의시작및종료시점 (552및 2020/175927 1»（：1^1{2020/002793
556)에 대응되고,두시점에서의 Pdet는각각열림배뇨근압 (opening detrusor pressure)및닫김배뇨근압 (closing detrusor pressure)에 대응한다.
[221] 늘롯 (530)에서 ,최고요속배뇨근압 (detrusor pressure at Qmax, PdetQmax)(580)는 배뇨단계동안요속 Qura이 최대인시점에서의 배뇨근압이고,
최저요속배뇨근압 (detrusor pressure at Qmin, PdetQmin) (582)는배뇨단계동안 최소배뇨근압이고,열림배뇨근압 (532)은배뇨가시작되었을때 배뇨근압이다. 닫김배뇨근압 (534)은배뇨가종료되는배뇨근압이다.
[222] 실시 예에서 , Qmax(554), PdetQmax(580), PdetQmin(582),열림배뇨근압 (532), 닫김배뇨근압 (534),및총배뇨량을포함할수있는몇몇특징들은요역동학적 지표를식별하고요역동학적 결론을얻기 위해사용될수있다.
[223] 도 11은본발명의시스템및방법에서요속의 함수로서 배뇨근압의플롯을 나타낸것이다.
[224] 실시 예에서,플롯 (530및 550)은플롯 (6W)을생성하는데사용될수있다.
[225] 도시된바와같이 ,플롯 (600)의 전체도메인은폐색 (obstructed)영역 ,비폐색 (unobstructed)영역 및불분명 (equivocal)영역등 3개의 영역들로구분될수 있다.플롯 (6W)이비폐색 영역에 있기 때문에,방광출구가막히지 않았다고 결론지을수있다.
[226] 대조적으로,요도를통한소변의흐름을막는양성 전립선비대증을가진
환자의 경우, Pdet대 Qura의플롯은플롯 (620)과유사한패턴을가질수있다.
[227] 그러한경우,환자는기계적방광줄구폐색 (mechanical bladder outlet obstruction, BOO)을나타내는것으로결론지을수있다.
[228] 따라서,실시 예에서, Pdet대요류의플롯의패턴은요역동학적결론을얻는 특징으로서사용될수있다.
[229] 방광출구폐색을수치적으로정량화하기위해 ,특정 공식을사용하여
방광출구폐색지수 (BOO지수)를도출할수있다.
[230] BOO지수 = PdetQmax ? 2 * Qmax
[231] 남성방광출구는 BOO지수에 따라폐쇄,불분명 및비폐쇄로분류될수있다 (예컨대, BOO index ñ 40(폐쇄); 20 < BOO index < 40(불분명);및 BOO지수 <
20(비폐쇄).
[232] 실시 예에서 ,장치 (130)로부터의 엑스선이미지는방광수축시방광요관역류, 전립선역류,배뇨근-괄약근협동장애,방광경부기능부실등의다양한지표를 결정하기 위해압력-요류검사동안사용될수있다.
[233] 도 W에서,배뇨시간 (590)은방광을비우는시간범위를나타낸다.
[234] 배뇨근저활동성 (detrusor underactivity)은방광수죽의 강도및/또는지속
시간의감소로정의되며 ,장기간방광배출및/또는정상적인시간내에 완전한 방광배출을달성하지못하는결과로이어진다.
[235] 도 12는본발명의시스템및방법에서방광내압측정 (배뇨단계의 데이터가 압력-요류검사에 대응하는경우)으로부터의 예시적인데이터를나타낸것이다. 2020/175927 1»（：1^1{2020/002793
[236] 도시된바와같이,플롯 (기 0)은정상방광 (기 2)의모산라를나타낼수있는반면, 플롯 (720)은저활동성배뇨근의 (722)의 Pdet를나타낼수있다.
[237] 배뇨단계 (702)동안,저활동성방광 (722),즉,저활동성배뇨근를갖는방광은 감소된강도로수축하여완전한방광비우기를달성하지못할수있다.
[238] 방광수축정도를수치적으로정량화하기위해 ,다음식을사용하여방광수축 지수 (bladder contractility index, BCI)를도줄할수있다.
[239] BCI = PdetQmax + 5*Qmax.
[24이 실시예에서,의료진은 BCI가 100미만일때방광이약한수축성을갖는다고 결론을내릴수있다 (BCI가 W0?150범위일때정상적인수축성, BCI가 150보다 클때강한수축력).
[241] 실시예에서 ,저활동성방광에서방광비우기정도를나타내는데사용될수 있는다른지표는방광배뇨효율 (BVE, bladder voiding efficiency)이며 ,이는다음 식에따른백분율로정의된다.
[242] BVE =(배뇨량/총방광용량) xlOO
[243] 예를들어 ,환자가 350mL의잔뇨량 (총방광용량 500mL)에서 150mL를비울 경우,환자의 BVE는 30 %이다.
[244] 실시예에서 ,배뇨단계동안의최대 Pdet, BCI,배뇨중 BVE및잔뇨량의
존재와같은특징을요역동학적지표들을식별하고요역동학적결론을얻기 위해사용될수있다.
[245] 이경우,의료진은배뇨완료후엑스선투시영상장치 (130)를사용하여정 성적으로잔뇨량을측정할수있다.
[246] 예를들어,의료진은요도카테터 (124)를통해방광내부의조영제를주입하고 엑스선투시영상장치 (130)에의해생성된투시영상을획득하고,이영상을 사용하여잔뇨량을추정할수있다.
[247] 외요도괄약근 (이하,요도괄약근또는괄약근)은전립선 (110)바로아래에 위치하며방광 (108)으로부터소변의흐름의개방/폐쇄를제어한다.
[248] 실시예에서,괄약근능력은요도단압검사를분석함으로써단독으로는
아니지만추정될수있다.
[249] 도 13은본발명의시스템및방법에서요도단압검사측정동안취해진
예시적인데이터를나타낸것이다.
[25이 요도측정동안,의료진은요도카테터 (124)를방광 (108)에삽입하고카테터의 제 2홀을통해액체를미리정해진일정한비율로방광내로연속적으로 주입하는한편,요도카테터 (124)는기설정된일정한인출률로요도를따라 천천히인출될수있다.
[251] 실시예들에서 ,요도카테터 (124)는카테터의말단부부분에위치되고
카테터의길이방향을따라서로약 6cm만큼분리된 2개의구멍을갖도록 변형될수있다.
[252] 실시예들에서,카테터를요도를따라일정한속도로빼내고액체는제 2 2020/175927 1»（：1^1{2020/002793 구멍을통해주입될동안방광내압 (820, Pves)은카테터의 제 1홀근처에 위치한 압력 센서에의해 연속적으로측정될수있고,요도압력 (850, Pura)은카테터의 제 2홀근처에위치한압력 센서에 의해지속적으로측정될수있다.
[253] 도 13에서 ,플롯 (820)은카테터의선단에위치한구멍을통해측정된
방광내압 (Pves)을나타낸다.
[254] 플롯 (850)은카테터의끝에서 제 2홀 (Pura)을통해측정된요도압력을
나타내고,플롯 (860)은 Pves(820)에의해감산된 Pura(850)에 대응하는요도폐쇄 압력을나타낸다.
[255] 실시 예에서,최대요도폐쇄 압력 (866)은최대요도압력 (864)으로부터
Pves(820)을차감함으로써 얻어질수있다.
[256] 예컨대,최대요도폐쇄압력 (866)은 68cmH20이고최대요도압력 (864)은
72cmH20이다.
[257] 도 13에서 ,압력 (868)은휴지 방광내압을나타낼수있고폭 (862)은요도압력이 Pves보다높은요도부분의 (기능적프로파일)길이를나타낼수있다.
[258] 예컨대 ,도 13에도시된바와같이 ,휴지방광내압은 6 cmH20일수있고
기능적프로파일길이는 74 mm일수있다.
[259] 최대요도압력,최대요도폐쇄압력 및기능적프로파일길이는요도의정적 기능적측면을나타내는지표를식별하기 위해사용될수있다.
[26이 실시 예들에서 ,복압성요누출압은복압성요실금의중증도및내인성
요도기능저하 (intrinsic sphincter deficiency)의존재를결정하기위한도구로서 사용될수있다.
[261] 실제로,의료진은발살바복압성요누출압 (VLPP)및기침유발복압성요누출압 (CLPP)등두가지유형의복압성요누출압 (ALPP)을측정할수있다.
[262] VLPP는방광내압 (910, Pves)의값을나타내며,이는배뇨근수축이 없는
상태에서요자제기전 (continence mechanism)을초과하여소변이누줄되는 방광내압의 값을나타내며， (그 모는소변누출을초래하는기침에의해유발된 방광내압의 값을나타낸다.
[263] 도 14는본발명의시스템및방법에서복압성요누출압측정으로부터의
예시적인데이터를나타낸것이다.
[264] 도시된바와같이 ,플롯 (910, 920, 930및 940)은각각 Pves, Pabd, Pdet및 EMG 신호를도시하며，여기서도 14의플롯은도 7의플롯과유사한방식으로획득될 수있다.
[265] 실시 예에서,복압성요누출압측정동안,그림의급격한피크포인트 (902)에 의해나타난바와같이의료진은환자로하여금여러번기침을하도록지시하며 , 영상장치 (130)를이용한엑스선투시영상을통해기침유발요실금 (불수의적 소변누출)을확인할수있다.
[266] 플롯 (910)을사용하여,의료진은기침유발복압성요누출압 (912)을확인할수 있으며,이는환자에게배뇨를야기한최소기침유발복압에해당한다. 2020/175927 1»（：1^1{2020/002793
[267] 유사하게,의료진은복압성요누출압 (922)을확인할수있는데,이는환자가 소변을누출시키는최소복부압박압력에해당한다.실시 예에서 ,소변누출은 복압성요누출압이 발생하는시점을결정하는데중요할수있다.
[268] 실시 예에서 ,측정된발살바복압성요누출압및기침유발복압성요누출압은 복압성요실금및내인성요도기능저하의심한정도를결정하여요역동학적 결론을얻기위해사용될수있는요역동학적지표들이다.
[269] 도 15는 ICS (International Continence Society)분류에따른요역동학적결론의 표를나타낸것이다.
[27이 도시된바와같이,표 W00의 각항목은하나이상의하부요로기능이상에
대응하는임상또는요역동학적지표 (또는간단히지표)일수있다.
[271] 예를들어,플롯 (420)의요역동학특징에기초하여,의료진은환자의방광이 과활동성인것으로결론을내릴수있다 (배뇨근과활동성).
[272] 의료진은도 4내지도 14의다른플롯으로부터추출된특징에 기초하여다른 요역동학적지표를확인할수있고,식별된지표와관련된하부요로기능이상을 결론지을수있다.
[273] 도 16은본발명의시스템및방법의하부요로기능이상진단시스템의
개략도이다.
[274] 도시된바와같이,시스템 (1100)은,기본임상데이터 (180)또는요역동학검사 결과 (186)로부터 데이터를획득하기위한데이터 획득스테이션 (1 W2)과, 데이터를저장하기위한데이터베이스 (1 W6)및데이터에 기초하여환자의 하부요로기능이상을진단하기 위한진단엔진 (H08)을포함하는진단 시스템 (1104)과,데이터 획득스테이션 (1102)과진단시스템 (1104)이서로 통신할수있는네트워크 (1112)를포함한다 (요역동학검사결과 (186)는도 2내지 9와함께설명된검사를통칭한다).
[275] 시스템 (1100)은네트워크 (1112)에 연결된다른장치를포함할수있다.예를 들어,진단시스템 (1104)은진단된장애를네트워크 (1112)에 연결된의료진의 컴퓨터 (도 16에도시되지 않음)에보고할수있다.예를들어 ,
데이터베이스 (1120)는데이터 획득스테이션 (H02)및진단
시스템 (1 W4)으로부터원격에 위치하고통신적으로연결될수있다.
[276] 실시 예에서 , 2개의구성요소 (1102및 1104)각각은컴퓨터일수있다.
대안적으로,컴포넌트 (1102,및/또는 1104)의하나이상의요소는별도의 컴퓨팅 설비로서구현될수있다.예를들어,데이터베이스 (1106)는진단엔진 (1108)과 물리적으로분리되어통신적으로연결될수있다.
[277] 도 17은본발명의시스템및방법의 데이터 획득스테이션의 개략도이다.
[278] 실시 에서,데이터 획득스테이션 (1102)은도 2의 컴퓨터 (132)와유사할수 있다.
[279] 도시된바와같이 ,데이터 획득스테이션 (1 W2)은,데이터 획득스테이션의 다른컴포넌트들을동작/조정하기 위한마이크로프로세서와같은 2020/175927 1»（：1^1{2020/002793 프로세서 (1202)와,스테이션의사용자로부터입력제어신호및데이터를 수신하기위한사용자인터페이스 (1204)와,데이터를저장하기위한
메모리 (1206)와,다양한이미지를디스플레이하기위한디스플레이 (1208)와,도 2및도 3의다양한센서/전극및이미징장치 (130)를제어하여그로부터 데이터를획득하기위한센서/카메라제어기 (1210)와,이미징장치 (130)로부터 수신된엑스레이및초음파이미지와같은이미지를처리하고분석하기위한 이미지프로세서 (1212)와,센서/카메라제어기 (1210)에의해획득된신호를 처리하기위한신호처리기 (1214)와,네트워크 (1112)에연결된
노드/스테이션뿐만아니라센서및촬상장치와같은다양한외부장치와 데이터를통신하기위한통신유닛 (1216)과,전원케이블,
Figure imgf000024_0001
다양한 단자를수용하기위한하나이상의포트 (1218)를포함한다.
[28이 실시예에서,상술한바와같이,센서/카메라제어기 (1210)는환자의
방광 (108)과같은내부장기의이미지를얻도록이미징장치 (130)를제어할수 있으며,이미징장치 (130)는엑스선투시영상모니터링시스템일수있다.
[281] 또한,센서/이미지제어기 (1210)는도 4내지도 14에도시된신호를얻도록 센서/전극을제어할수있다.
[282] 실시예에서 ,사용자인터페이스 (1204)는환자기본임상데이터를입력하기 위한키보드및/또는마우스를포함할수있다.실시 예에서,디스플레이 (1208)는 사용자가데이터획득스테이션 ( 02)과상호작용할수있게하는터치 스크린일수있다.
[283] 실시예에서 ,포트 (1218)는도 1내지도 2의센서가데이터획득
스테이션 (1102)으로신호를통신할수있도록다양한단자를수용할수있다.
[284] 실시예에서,포트 (1218)는무선신호를도 2내지도 3의센서와통신하는무선 통신연결을포함할수있다.
[285] 도 16을다시참조하면,실시 예에서,진단엔진 (1108)은데이터획득
스테이션 ( 02)으로부터데이터를수신하고수신된데이터를분석하여환자의 하부요로기능이상을진단할수있으며 ,여기서수신된데이터는요역동학검사 및환자기본임상데이터로부터의데이터를포함할수있다.
[286] 실시예에서,진단엔진 ( 08)은소프트웨어,하드웨어장치또는이들의조합 일수있다.
[287] 실시예에서,진단엔진 (1108)은인공지능 (쇼1)알고리즘을포함할수있다.실시 예에서,진단엔진 ( 08)은수신된데이터로부터특징을추출하고,기본임상 데이터및/또는요역동학적지표의결과를식별하고,기본임상데이터또는 요역동학적지표의식별된결과로부터환자의하부요로기능이상을특징화할 수있다.
[288] 실시예에서 ,진단된하부요로기능이상은표 00의항목중하나이상을 포함할수있다.
[289] 실시예에서,진단엔진 (1108)은,도 4내지도 14에도시된데이터로부터 2020/175927 1»（：1^1{2020/002793 특징을주줄할수있다.
[29이 보다구체적으로, AI알고리즘은의료진을대체하여도 4내지도 9와관련하여 설명된특징들을추출할수있다.
[291] 예를들어,다른예에서,도 10에서논의된바와같이,진단엔진 (1108)은
방광내압측정의 배뇨단계동안획득된데이터의특징을추출할수있으며 , 상술한특징은최고요속 (maximum flow rate, Qmax),최고요속배뇨근압
(PdetQmax),배뇨근-괄약근협동장애유무,열림배뇨근압 (opening detrusor pressure),닫힘배뇨근압 (closing detrusor pressure),배뇨시 최소배뇨근압
(minimum detrusor pressure)을포함할수있다.
[292] 다른예에서 ,도 11및도 12에서논의된바와같이 ,상술된특징은
방광내압측정동안획득된데이터의다양한특징으로부터 얻어질수있으며, 방광출구폐색지수 (BOO index),방광수축지수 (BCI)및방광배뇨효율 (BVC)을 포함한다.
[293] 다른예에서 ,도 13에서논의된바와같이 ,상술된특징은요도내압측정동안 취해진데이터의다양한특징으로부터 얻어질수있으며,최대요도내압
(maximum urethral pressure),최대요도폐쇄압 (maximum urethral closure pressure), 종요도길이 (total profile length)및기능요도길이 (functional profile leng比！)와같은 지표들을포함한다.
[294] 다른예에서 ,도 14에서논의된바와같이 ,상술된특징은복압성요누출압
측정 (VLPP및 CLPP포함)동안취해진데이터의다양한특징으로부터 얻어질 수있다.
[295] 실시 예에서,진단엔진 (1108)은주요하부요로증상,환자의 의학적
이력 (과거의 의학적 이력,이전수술이력 및/또는약물이력),신체검사 (사지의 감각과같은일반적인신경학적검사,집중신경학적검사포함),설문지, 배뇨일지 (또는배뇨횟수-배뇨량일지),배뇨후잔뇨량,신장상태 (CT또는 초음파영상),및방광내시경등의 임상평가로부터 생성된기본임상
데이터 (180)로부터지표를추출할수있다.
[296] 실시 예에서,진단엔진 (1 W8)은감독학습프로세스에의해훈련될수있다.
[297] 훈련단계동안,진단엔진 (1108)은훈련데이터를사용할수있으며,여기서 훈련데이터각각은한쌍의 입력객체와원하는출력 객체를포함할수있다.
[298] 실시 예에서,입력 객체는기본임상데이터 (180)및도 4내지도 14에도시된 플롯/데이터와같은요역동학검사결과 (186)로부터의하나이상의 데이터를 포함할수있으며,여기서 원하는출력 객체는입력 객체와연관될수있고,표 W00에 나열된환자의하부요로기능이상을포함한다.
[299] 실시 예에서,숙련된의료진은많은수의 입력 객체를분석하고원하는출력 객체를준비하기위해각입력 객체에 대한환자의하부요로기능이상을진단할 수있다.
[300] 실시 예에서,훈련된진단엔진 (1 W8)은새로운입력객체를수신하고환자의 2020/175927 1»（：1^1{2020/002793 하부요로기능이상을진단하기위해사용될수있다.
[301] 도 18은본발명의시스템및방법에서진단엔진을작동시키기위한예시적인 프로세스를도시한흐름도이다.
[302] 1302단계에서,진단엔진 (1108)은하부요로기능이상과관련된데이터를
수신할수있다.
[303] 실시예에서 ,진단엔진 (1 8)은데이터를하나이상의하부요로기능이상과 연관시키도록훈련될수있다.
[304] 실시예에서,수신된데이터는 (도 4내지도 14와관련하여논의된바와같이) 요역동학검사결과 (186)로부터의데이터및임상평가로부터생성된기본임상 데이터 (180)를포함할수있다.
[305] 이후, 1304단계에서,진단엔진 (1108)은수신된데이터로부터하나이상의 특징을주줄할수있다.
[306] 다음으로, 1306단계에서,진단엔진 (1108)은추출된특징에기초하여환자의 기본임상데이터 (180)의하나이상의결과및/또는요역동학검사결과 (186,또는 요역동학적지표)를식별할수있다.
[307] 실시예에서,도 4내지도 5와관련하여설명된바와같이,진단엔진 (1108)에 의해수신된데이터는도 4및도 5의플롯 (210, 240, 220, 230및 250)을포함할수 있으며,이플롯은요류측정에서얻을수있으며각각요속, EMG신호및 배뇨량을나타낸다.
[308] 실시예에서, 1304단계에서,진단엔진 (1108)은입력데이터로부터특징을 추출할수있고,여기서특징은배뇨의플롯 (240),최대요량 (222, 242),배뇨 시간 (224),주저시간,총배뇨량및잔뇨량일수있다.
[309] 실시예에서, 1306단계에서,진단엔진 ( 08)은추출된특징을사용하여환자의 하부요로기능이상과관련된요역동학적지표 (또는간단히지표)를식별할수 있다.
[310] 예를들어,진단엔진 (1108)은요류의플롯 (240)이다수의피크를가질때
간헐적인흐름패턴을식별할수있다.
[311] 다른예에서,배뇨시간 (224)이정상범위내에있을때,배뇨량이적절한
경우 (바람직하게는 150å1止초과),진단엔진 (1108)은환자의소변흐름이 정상이라고결론지을수있다.
[312] 또다른예에서,최고요속 (220)이너무높거나 (또는너무낮은),배뇨
시간 (224)이너무짧은 (또는너무긴)경우,진단엔진 (1108)은수퍼플로우 (또는 폐색)패턴을식별할수있다.
[313] 실시예에서,진단엔진 ( 08)에의해수신된데이터는도 7의하나이상의 플롯 (320, 330, 340, 350및 360)을포함할수있으며 ,이플롯은방광측정의저장 단계동안취해질수있고,
Figure imgf000026_0001
신호를각각 나타낸다.
[314] 충전기방광내압측정에서,가로축은시간에해당한다.충전기방광내압측정 2020/175927 1»（：1^1{2020/002793 중방광이일정한속도로충전되기때문에,시간은결국충전량을반영한다.
[315] 실시예에서,진단엔진 (1108)은이러한플롯 (311, 3기, 376)을사용할수있다.
[316] 실시예에서, 1304단계및 1306단계에서,진단엔진 (1108)은 3A내지 3C의
플롯으로부터특징들을추출하여방광유순도 (bladder compliance)를확인할수 있으며,여기서특징은저장단계동안의방광충전곡선 (376)기울기와환자의첫 중전감각 (first sensation of filling),첫배뇨욕구 (first desire to void),및강한배뇨 욕구 (strong desire to void)를느낄때의방광용적 (bladder volume)을포함할수 있다.
[317] 예를들어,저장단계의초기단계에서곡선 (376)의기울기가빠르게증가하면, 진단엔진 (1108)은낮은방광유순도 (low bladder compliance)라고판단할수있다.
[318] 다른예에서,방광용적이예상평균정상용량에도달하지않았을때환자가 강한배뇨욕구 (strong desire to void)를느낀다면,진단엔진 (1108)은낮은 방광용량 (low bladder capacity)라고판단할수있다.
[319] 실시예들에서,진단엔진 (1 W8)에의해수신된데이터는도 7의플롯 (330및 350)을포함할수있으며 ,이플롯은각각 Pves, Pdet를나타낼수있다.
[32이 실시예에서, 1304및 1306단계에서,진단엔진 (1108)은배뇨근요누출압을
포함하는특징을추출할수있고,추출된특징에기초하여,진단엔진 (H08)은 장차신장등상부요로계손상이유발되리라는예후적인위험인자로서 요역동학적지표를파악할수있다.
[321] 실시예들에서,진단엔진 (1108)은진단엔진 (1108)에의해수신된데이터 (320, 330, 340및 350)를사용하여도 9의플롯 (410, 420및 430)을생성할수있으며, 여기서데이터는방광내압측정의저장단계에서얻어질수있다.
[322] 실시예에서, 1304단계및 1306단계에서,진단엔진 (1108)은저장단계동안의 불수의적배뇨근수축횟수와같은특징을추출하고,저장단계동안다수의 불수의적배뇨근수축이발생할때위상성수축을파악할수있다.
[323] 실시예들에서,진단엔진 (1108)은저장단계동안불수의적배뇨근수축의
유형과같은다른특징을주줄하고, (1)불수의적배뇨근수죽이저장단계의 초기에발생할때위상성배뇨근과활동성, (2)검사자에의한배뇨지시없이 방광이수죽할때환자의최대방광용량 (maximum cystometric capacity)근처에서 말기배뇨근과활동성과같은지표를파악할수있다.
[324] 진단엔진 (1 W8)은또한엑스선이미지를수신하여방광경부의특징 (열림또는 닫힘)및엑스선이미지로부터누출검출과같은특징을추출할수있다.
[325] 실시예에서,진단엔진 (1108)에의해수신된데이터는도 10의플롯 (510, 520, 530, 540및 550)을포함할수있으며 ,이플롯은각각 Pves, Pabd, Pdet, EMG및 요속을나타낸다.
[326] 실시예에서 ,배뇨단계동안의 EMG신호 (540)또는엑스선투시영상은
배뇨근-괄약근협동장애여부를결정하기위해사용될수있다.
[327] 실시예에서,진단엔진 (1 W8)은입력데이터를사용하여도 11및 7에서 2020/175927 1»（：1^1{2020/002793 플롯 (610, 710, 720))을생성할수있다.
[328] 실시예에서, 1304단계및 1306단계에서,진단엔진 (1108)은입력
데이터로부터특징을추출하고특징으로부터다양한결과를파악할수있으며, 여기서특징은최고요속 (554),열림배뇨근압 (532),닫김배뇨근압 (534),총배뇨량, 압력 (Pdet)-요류플롯의패턴 (610, 620),배뇨단계동안최고요속배뇨근압
(PdetQmax)및잔뇨량을포함할수있다.
[329] 예를들어,플롯 (720)에도시된바와같이,진단엔진 (1108)은배뇨단계동안 최고배뇨근압 (Pdet)이낮다면배뇨근저활동성 (detrusor underactivity)을식별할 수있다.
[33이 다른예에서,압력-요류플롯 (620)이폐색영역에 있을때,진단엔진 (1108)은 방광출구폐색을식별할수있다.
[331] 실시예에서,진단엔진 (1108)에입력된데이터는도 13의플롯 (810, 820, 830, 840, 850및 860)을포함할수있으며 ,이플롯은요도단압검사측정동안 획득되고, EMG신호,방광내압,복압,배뇨근압,카테터끝단 (tip)근처의요도 압력및요도폐쇄압 (urethral closure pressure)을나타낸다.
[332] 실시예에서,진단엔진 (1108)은플롯 (820및 850)을사용하여요도폐쇄압 (860) 늘롯을생성할수있다.
[333] 실시예에서, 1304단계에서,진단엔진 (1108)은도 13의플롯으로부터특징을 주줄할수있으며 ,여기서특징은최대요도내압 (maximum urethral pressure)(864), 최대요도폐쇄압 (urethral closure pressure)및기능요도길이 (functional profile length)를포함할수있다.
[334] 실시예에서, 1306단계에서,진단엔진은최대요도폐쇄압 (864)이낮을때
괄약근기능부실 (sphincter incompetence)을나타내는간접적증거와같은지표를 식별할수있다
[335] 도 13에서,플롯 (810, 820, 830및 840)은도 7에서의대응플롯과유사하다.즉, 플롯 (810, 820, 830및 840)은 EMG신호,방광압,복압및배뇨근압을나타낸다.
[336] 플롯 (850)은카테터 (124)끝단 (182)에서측정된압력을나타내고,플롯 (860)은 카테터끝단 (182)에서측정된압력 (850)과방광내압 (820)사이의압력차이를 나타낸다.여기서압력차이는요도압이라할수있다.
[337] 실시예에서,진단엔진 (1108)에의해수신된데이터는도 14의플롯 (910, 920, 930및 940)을포함할수있으며 ,이들플롯은각각 Pves, Pabd, Pdet및 EMG 신호를나타낼수있다.
[338] 실시예에서, 1304단계및 1306단계에서,진단엔진 (1108)은발살바
복압성요누출압 (VLPP)및기침유발복압성요누출압 (CLPP)을포함하는특징을 추출할수있고,추출된특징에기초하여,진단엔진 (H08)은복압성요실금의 심각도및내인성요도기능저하와같은지표들을식별할수있다.
[339] 1308단계에서,진단엔진 (1108)은식별된요역동학적지표와관련된하나
이상의하부요로기능이상의정보를포함하는출력을생성할수있다. 2020/175927 1»（：1^1{2020/002793
[34이 실시 예들에서,식별된요역동학적지표는표 W00의하나이상의 아이템을 포함할수있다.
[341] 환자의하부요로기능이상은하나이상의비정상적인기본임상데이터 (180) 또는요역동학적지표관련될수있고,상이한하부요로기능이상이공통의 지표를가질수있음에유의한다.
[342] 13 W단계에서,의료진의환자의하부요로기능이상을진단하고치료할수 있도록출력내용이의료진의 컴퓨터로전송될수있다.
[343] 의료진들은도 4내지도 9와관련하여 설명된측정들중일부를수행하지못할 수있음에유의한다.
[344] 예를들어,직장암수술을받아항문이 없는환자는전복부에 형성된장루 (abdominal stoma)를통해배변할수있다.
[345] 그러한경우에,실시 예에서，복부장루를통해직장카테터 (122)를삽입하여 복압을측정할수있다.유사하게,요도가없는환자는하복부에 기존에설치된 상치골방광루카테터 (suprapubic cystostomy catheter)를통해 압력을즉정할수 있다.
[346] 그러한경우에 ,실시 예에서 ,상치골방광루카테터가요도카테터 (124)역할을 하는것으로간주하고방광내압을측정할수있다.
[347] 실시 예에서,도 4내지도 9의 데이터는표준요역동학검사에서 획득될수 있으며 ,여기서 검사동안환자는고정된위치에 있다.
[348] 대안적으로,이동성요역동학검사 (ambulatory urodynamic study)에서동일한 데이터가획득될수있으며,여기서환자는검사중에요역동학적 압력 변환기 및신호기록장치와함께 이동할수있다.
[349] 실시 예에서 ,하나이상의 컴퓨팅시스템은여기에 제시된방법 ,기능및/또는 동작중하나이상을수행하도록구성될수있다.
[35이 본명세서에 기술된방법 ,기능및/또는동작중적어도하나이상을구현하는 시스템은적어도하나의 컴퓨팅시스템에서동작하는애플리케이션또는 애플리케이션을포함할수있다.
[351] 컴퓨팅시스템은하나이상의 컴퓨터 및하나이상의 데이터베이스를포함할 수있다.컴퓨터시스템은단일시스템,분산시스템,클라우드기반컴퓨터 시스템또는이들의조합일수있다.
[352] 본발명은,랩톱컴퓨터 ,데스크탑컴퓨터 및서버를포함하지만이에 제한되지 않는데이터를처리할수있는임의의 명령실행/계산장치또는시스템에서 구현될수있음에유의해야한다.
[353] 본발명은또한다른컴퓨팅장치 및시스템에서구현될수있다.
[354] 또한,본발명의실시예는소프트웨어 (펌웨어포함),하드웨어또는이들의 조합을포함하는다양한방식으로구현될수있다.
[355] 예를들어,본발명의다양한실시 예를실시하기위한기능은이산로직
컴포넌트,하나이상의 ASIC (application- specific integrated circuit)및/또는 2020/175927 1»（：1^1{2020/002793 프로그램제어를포함하는다양한방식으로구현되는컴포넌트에 의해수행될 수있다.
[356] 이들항목이구현되는방식은본발명에중요하지 않다는점에유의해야한다.
[357] 본발명의 세부사항을설명하였지만,본발명의하나이상의실시예를
구현하는데사용될수있는예시적인시스템 (1400)은도 19를참조하여 설명한다.
[358] 도 1내지도 17와관련하여 설명된컴퓨팅장치는시스템 (1400)에하나이상의 컴포넌트를포함할수있다.도 19에도시된바와같이,시스템 (1400)은컴퓨팅 리소스를제공하고컴퓨터를제어하는중앙처리장치 (CPU)(1401)를포함한다.
[359] CPU(1401)는마이크로프로세서등으로구현될수있으며,수학계산을위한 그래픽프로세서 및/는부동소수점코프로세서를포함할수도있다.
[360] 시스템 (1400)은 RAM (random-access memory)및 ROM (read-only memory)의 형태 일수있는시스템메모리 (1402)를포함할수있다.
[361] 도 19에도시된바와같이 ,다수의제어기 및주변장치가제공될수도있다. 입력 제어기 (1403)는키보드,마우스또는스타일러스와같은다양한입력 장치 (1404)에 대한인터페이스를나타낸다.
[362] 또한,입력제어기 (1403)는스캐너 (1406)와통신하는스캐너 제어기 (1405)가 있을수도있다.
[363] 시스템 (1400)은하나이상의 저장장치 (1408)와인터페이스하기위한저장
제어기 (1407)를포함할수있으며,이들각각은자기 테이프또는디스크와같은 저장매체,또는운영 체제,유틸리티를위한명령어프로그램을기록하는데 사용될수있는광매체,본발명의다양한실시예를구현하는프로그램의포함할 수있는애플리케이션을포함한다.
[364] 저장장치 1408)는또한본발명에 따라처리된데이터또는처리될데이터를 저장하는데사용될수있다.시스템 (1400)은음극선관 (CRT),박막
트랜지스터 (TFT)디스플레이,또는다른유형의디스플레이 일수있는 디스플레이장치 (1411)에 인터페이스를제공하기 위한디스플레이
제어기 (1409)를포함할수있다.
[365] 시스템 (1400)은또한프린터 (1413)와통신하기위한프린터제어기 (1412)를 포함할수있다.
[366] 통신제어기 (1414)는하나이상의통신장치 (1415)와인터페이스할수있으며, 이는시스템 (1400)이 인터넷,이더넷클라우드, FCoE/DCB클라우드,근거리 통신망 (LAN), WAN (Wide Area Network), SAN (Storage Area Network)을 포함하는다양한네트워크중임의의 네트워크를통하거나,적외선신호를 포함한적절한전자기 캐리어신호를통해원격장치에 연결될수있게 한다.
[367] 도시된시스템에서 ,모든주요시스템구성요소는하나이상의물리적버스를 나타낼수있는버스 (1416)에 연결될수있다.그러나,다양한시스템구성요소는 서로물리적으로근접하거나근접하지 않을수있다. 2020/175927 1»（：1^1{2020/002793
[368] 예를들어,입력 데이터 및/또는출력 데이터는하나의물리적 위치에서다른 물리적 위치로원격으로전송될수있다.또한,본발명의다양한실시예를 구현하는프로그램은네트워크를통해원격 위치 (예를들어,서버)로부터 액세스될수있다.
[369] 이러한데이터 및/또는프로그램은하드디스크,플로피 디스크및자기
테이프와같은자기 매체； CD-ROM및홀로그래픽장치와같은광학매체 ;광 자기 매체 ;및 ASIC (application-specific integrated circuit), PLC(programmable logic device),플래시 메모리장치, ROM및 RAM장치와같은프로그램코드를저장 또는저장하도록특별히구성된하드웨어장치를포함하는다양한기계판단 가능한매체를통해 전달될수있지만이에 제한되지 않는다.
[37이 본발명의실시 예에서 단계가수행되도록하나이상의프로세서또는처리 유닛에 대한명령으로하나이상의 비일시적 컴퓨터판독가능매체상에 인코딩될수있다.
[371] 하나이상의 비일시적 컴퓨터판독가능매체는휘발성 및비휘발성 메모리를 포함해야한다.
[372] 하드웨어구현또는소프트웨어/하드웨어구현을포함하여 대안적인구현이 가능하다는점에유의해야한다.
[373] 하드웨어구현기능은 ASIC,프로그래머블어레이，디지털신호처리회로
등을사용하여실현될수있다.
[374] 따라서,임의의 청구항에서의 "수단”이라는용어는소프트웨어 및하드웨어 구현모두를포함하도록의도된다.유사하게,본명세서에서사용되는용어 "컴퓨터판독가능매체또는매체”는그위에구현된명령어프로그램을갖는 소프트웨어 및/또는하드웨어또는이들의조합을포함한다.
[375] 이러한구현대안을고려하여,도면및첨부된설명은당업자가프로그램
코드 (즉,소프트웨어)를작성하고/하거나,필요한처리를하기위한회로 (즉, 하드웨어)를제조하기위해필요한기능적 정보를제공한다는것을이해해야 한다.
[376] 본발명의실시 예는또한다양한컴퓨터구현동작을수행하기 위한컴퓨터 코드를갖는비일시적유형의 컴퓨터판독가능매체를갖는컴퓨터제품에 관련될수있음에유의해야한다.
[377] 상기 매체 및컴퓨터코드는본발명을위하여특별히설계되고구성된
것들이거나당업자에게공지되어사용가능한것일수도있다.
[378] 유형의 컴퓨터판독가능매체의 예는하드디스크,플로피 디스크및자기
테이프와같은자기 매체； CD-ROM및홀로그래픽장치와같은광학매체 ;광 자기 매체 ;및 ASIC (application-specific integrated circuit), PLC (programmable logic device),플래시 메모리장치 및 ROM및 RAM장치와같은프로그램코드를 저장또는저장하도록특별히구성된하드웨어장치를포함하나이에 제한되지 않는다. 2020/175927 1»（：1^1{2020/002793
[379] 컴퓨터코드의 예로는컴파일러에서 생성 한기계코드및컴퓨터가
인터프리터를사용하여실행하는고급코드가포함된파일을포함할수있다.
[38이 본발명의실시 예는처리장치에 의해실행되는프로그램모듈에 있을수있는 기계실행가능명령어로서 전체적으로또는부분적으로구현될수있다.
[381] 프로그램모듈의 예로는라이브러리,프로그램,루틴,객체,구성요소및
데이터구조를포함할수있다.
[382] 분산컴퓨팅환경에서프로그램모듈은물리적으로로컬,원격중어느하나 이상에 위치할수있다.
[383] 당업자는컴퓨팅시스템또는프로그래밍 언어가본발명의실시에중요하지 않다는것을인식할것이다.
[384] 당업자는전술한많은요소들이물리적으로및/또는기능적으로서브모듈로 분리되거나함께결합될수있음을인식할것이다.
[385] 상술한실시 예는예시적인것이며본발명의범위를제한하지 않음은
당업자에게 이해될것이다.
[386] 본명세서를읽고도면을연구할때 당업자에게명백한모든순열,향상,등가, 조합및개선은본발명의 진정한사상및범위 내에포함되는것으로의도된다. 산업상이용가능성
[387] 본발명은하부요로기능이상의 진단과관련된모든산업분야에서 이용될수 있다.

Claims

2020/175927 1»（：1/10公020/002793 청구범위
[청구항 1] 환자에대한요로계검사로부터획득된데이터를수신한진단시스템이 상기데이터를하나나그이상의하부요로기능이상과연관시키도록 훈련하는단계;
상기수신된데이터로부터하나나그이상의특징을추출하는단계; 추출된상기하나나그이상의특징에기초하여하나나그이상의환자 요역동학적지표를식별하는단계;및
하나나그이상의식별된상기요역동학적지표와관련된하나나그 이상의하부요로기능이상의정보를포함하는출력을생성하는단계를 포함하는방법.
[청구항 2] 청구항 1에있어서,
상기요로계검사는요류검사를포함하고,
상기수신된데이터는환자의요도괄약근에의해생성된전기활동을 나타내는근전도 (EMG)신호중적어도하나를포함하고, 상기근전도 (EMG)신호는,
환자의환자의요도괄약근또는골반근육에의해생성된전기적활성과, 환자의요속플롯과,
환자의배뇨량플롯을포함하는방법 .
[청구항 3] 청구항 2에있어서,
상기하나이상의특징은,
상기요속플롯에서적어도하나의최대요속과,
배뇨시간과,
상기요속플롯에서복수의국소최대값을포함하는방법.
[청구항 4] 청구항 1에있어서,
상기요로계검사는방광내압측정을포함하고,
상기수신된데이터는근전도 (EMG)신호중적어도하나를포함하고, 상기근전도 (EMG)신호는,
환자의요도괄약근또는골반근육에의해생성된전기적활성과, 환자의방광의채워진액체의용량플롯과,
환자의복압플롯과,
환자의방광내압플롯과,
환자의방광의잔뇨량플롯을포함하는방법 .
[청구항 5] 청구항 4에있어서,
환자의방광에채워진액체의용적과배뇨근압간의플롯을생성하는 단계를더포함하고,
상기배뇨근압은복압에의해차감된방광내압이고,
상기하나이상의특징은, 2020/175927 1»（：1^1{2020/002793 상기방광내압측정의저장단계동안상기배뇨근압플롯의적어도 하나의배뇨근압기울기와,
환자가강한배뇨욕구 (strong desire to void)를느낄때의액체용량과, 불수의적배뇨근수축이발생할때의액체의용량과,
상기저장단계동안에일어난다수의불수의적배뇨근수축을포함하는 방법.
［청구항 6］ 청구항 4에있어서,
배뇨근압대요류간의플롯을생성하는단계를더포함하고, 상기배뇨근압은복압에의해차감된방광내압이고,
상기하나이상의특징은,
상기배뇨근압대요류플롯의적어도하나의패턴과, 환자가배뇨를시작할때상기배뇨근압값과,
환자가배뇨를정지할때상기배뇨근압값과,
요속의최대값을포함하는방법 .
［청구항 7］ 청구항 4에있어서,
환자방광내의액체용량에대한배뇨근압플롯을생성하는단계를더 포함하고,
상기배뇨근압은복압에의해차감된방광내압이고,
상기하나이상의특징은,
상기방광내압측정의배뇨단계동안상기배뇨근압플롯의배뇨근압 평균값을포함하는방법 .
［청구항 8］ 청구항 1에있어서,
상기요로계검사는요도단압검사측정을포함하고,
상기수신된데이터는,적어도하나의방광내압플롯과,압력센서가 환자의요도를따라이동하는동안압력센서에의해측정된요도압 플롯을포함하는방법 .
［청구항 9］ 청구항 8에있어서,
요도압플롯프로파일을생성하는단계를더포함하고, 상기요도압은요도압센서에의해측정된압력과방광내압사이의 차이이고,
상기하나이상의특징은,
상기요도단압검사플롯에서요도압의최대값을포함하는방법 .
［청구항 1이 청구항 1에있어서,
상기요로계검사는,누출압측정을포함하고,
상기수신된데이터는,
환자의요도괄약근또는골반근육에의해생성된전기적활동을 나타내는근전도 (EMG)신호중적어도하나와,
복압플롯과, 2020/175927 1»（：1^1{2020/002793 방광내압의플롯을포함하고,
상기하나이상의특징은,
발살바복압성요누출압 나 ),기침유발복압성요누출압 ((:나平)및 배뇨근요누출압 나平)중적어도하나를포함하는방법.
［청구항 11］ 청구항 1에 있어서,
투시요역동학검사결과에서하나나그이상의아티팩트 (3 꾜^0를자동 감지하고스크리닝하는단계와,
상기하나나그이상의아티팩트 (3 ^0를나열하는단계를더포함하는 방법.
［청구항 12］ 하나나그이상의프로세서와,
상기하나이상의프로세서에통신가능하게결합되고,하부요로 기능검사로부터 획득된데이터를하나나그이상의하부요로기능이상과 연관시키도록훈련되는진단엔진을포함하고,
상기 진단엔진은,
환자의하부요로기능검사로부터 얻은데이터를수신하는단계와, 상기수신된데이터로부터하나나그이상의특징을추출하는단계와, 추출된상기하나나그이상의특징에기초하여환자의하나나그이상의 요역동학적지표를확인하는단계와,
상기 확인된지표와관련된하나나그이상의환자하부요로기능이상의 정보를포함하는출력을생성하는단계를수행하는시스템.
［청구항 청구항 12에 있어서,
상기하나이상의특징은,
상기요속플롯에서 적어도하나의 최대요속과,
배뇨시간과,
상기요속플롯에서복수의국소최대값을포함하는시스템.
［청구항 14］ 청구항 13에 있어서,
상기요로계검사는요류검사를포함하고,
상기수신된데이터는근전도 (EMG)신호중적어도하나를포함하고, 상기근전도 (EMG)신호는,
환자의환자의요도괄약근또는골반근육에 의해생성된전기적활성과, 환자의요속플롯과,
환자의 배뇨량플롯을포함하는시스템.
［청구항 15］ 청구항 12에 있어서,
상기요로계검사는방광내압측정을포함하고,
상기수신된데이터는근전도 (EMG)신호중적어도하나를포함하고, 상기근전도 (EMG)신호는,
환자의요도괄약근또는골반근육에의해 생성된전기적 활성과, 환자의 방광의채워진액체의용량플롯과, 2020/175927 1»（：1^1{2020/002793 환자의복압플롯과,
환자의방광내압플롯과,
환자의방광의잔뇨량플롯을포함하는시스템.
［청구항 16］ 청구항 15에있어서,
상기진단엔진은,
환자의방광에채워진액체의용량에대한배뇨근압플롯을생성하는 단계를더수행하고,
상기배뇨근압은복압에의해차감된방광내압이고,
상기하나이상의특징은,
상기방광내압측정의저장단계동안상기배뇨근압플롯의적어도 하나의배뇨근압기울기와,
환자가강한배뇨욕망을느낄때의액체의용량과,
불수의적배뇨근수축이발생할때의액체의용량과,
상기저장단계동안다수의불수의적배뇨근수축을포함하는시스템. ［청구항 17］ 청구항 15에있어서,
상기진단엔진은,
배뇨근압대요류플롯을생성하는단계를더수행하고, 상기배뇨근압은복압에의해차감된방광내압이고,
상기하나이상의특징은,
상기배뇨근압대요속플롯의적어도하나의패턴과,
환자가배뇨를시작할때상기배뇨근압값과,
환자가배뇨를정지할때상기배뇨근압값과,
요속의최대값을포함하는시스템.
［청구항 18］ 청구항 15에있어서,
상기진단엔진은,
환자의방광내액체의용량에대한배뇨근압플롯을생성하는단계를더 수행하고,
상기배뇨근압은복압에의해차감된방광내압이고,
상기하나이상의특징은,
상기방광내압측정의배뇨단계동안상기배뇨근압플롯의배뇨근압 평균값을포함하는시스템.
［청구항 19］ 청구항 12에있어서,
상기요로계검사는요도단압검사측정을포함하고,
상기수신된데이터는,적어도하나의방광내압플롯과,압력센서가 환자의요도를따라이동하는동안압력센서에의해측정된요도압력 늘롯을포함하는시스템.
［청구항 2이 청구항 19에있어서,
상기진단엔진은요도압플롯프로파일을생성하는단계를더수행하고, 2020/175927 1»（：1^1{2020/002793 상기요도압력은요도압센서에의해측정된압력과방광내압사이의 차이이고,
상기하나이상의특징은,
상기요도압의플롯의요도압의최대값을포함하는시스템 [청구항 21] 청구항 12에있어서,
상기요로계검사는요누출압측정을포함하고,
상기수신된데이터는,
환자의요도괄약근또는골반근육에의해생성된전기적활동을 나타내는근전도（EMG）신호중적어도하나와,
복압플롯과,
방광내압의플롯을포함하고,
상기하나이상의특징은,
발살바복압성요누출압（ 나 ）,기침유발복압성요누출압（（:나平）및 배뇨근요누출압必나平）중적어도하나를포함하는시스템.
[청구항 22] 청구항 12에있어서 ,
투시요역동학검사결과에서하나나그이상의아티팩트（3 꾜^0를자동 감지하고스크리닝하는단계와,
상기하나나그이상의아티팩트（3 꾜^0를나열하는단계를더수행하는 시스템.
[청구항 23] 청구항 12에있어서,
상기요로계검사는요누출압측정을포함하고,
상기수신된데이터는,
환자의요도괄약근또는골반근육에의해생성된전기적활동을 나타내는근전도（EMG）신호중적어도하나와,
복압플롯과,
방광내압의플롯을포함하고,
상기하나이상의특징은,
발살바복압성요누출압（ 나平）및기침유발복압성요누출압（（:나平）중 적어도하나를포함하는시스템.
PCT/KR2020/002793 2019-02-27 2020-02-27 하부요로 기능이상의 진단 시스템 및 방법 WO2020175927A1 (ko)

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