WO2013109163A1 - Method for measuring urinary bladder pressure and device for implementing thereof - Google Patents

Method for measuring urinary bladder pressure and device for implementing thereof Download PDF

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Publication number
WO2013109163A1
WO2013109163A1 PCT/RU2012/001074 RU2012001074W WO2013109163A1 WO 2013109163 A1 WO2013109163 A1 WO 2013109163A1 RU 2012001074 W RU2012001074 W RU 2012001074W WO 2013109163 A1 WO2013109163 A1 WO 2013109163A1
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WO
WIPO (PCT)
Prior art keywords
urinary bladder
pressure
balloon
measuring
battery cell
Prior art date
Application number
PCT/RU2012/001074
Other languages
French (fr)
Inventor
Alexey Olegovich LOBKAREV
Oleg Alexandrovich LOBKAREV
Original Assignee
Lobkarev Alexey Olegovich
Lobkarev Oleg Alexandrovich
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lobkarev Alexey Olegovich, Lobkarev Oleg Alexandrovich filed Critical Lobkarev Alexey Olegovich
Publication of WO2013109163A1 publication Critical patent/WO2013109163A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/20Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202Assessing bladder functions, e.g. incontinence assessment
    • A61B5/205Determining bladder or urethral pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846Arrangements 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
    • A61B5/6867Arrangements 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 specially adapted to be attached or implanted in a specific body part
    • A61B5/6874Bladder

Definitions

  • the inventions relate to medicine and, in particular, to urology, and are intended for measuring the urinary bladder pressure in diagnostics and therapeutic procedures.
  • Intravesical pressure is a key indicator in diagnostics and treatment of such urological diseases as prostate adenoma, uroschesis, urinary incontinence, etc.
  • the known catheter is inserted into the urinary bladder through the urethra, where it remains until the end of diagnostics or treatment that completely distorts natural conditions, is accompanied by obstruction and irritation of the urethra and impacts negatively on the effectiveness of the diagnostics or treatment.
  • the catheter is inserted by the means of a suprapubic puncture and/or layered dissection of tissues from skin to urinary bladder wall, where it remains until the end of the diagnostics or treatment.
  • This technique of the catheter insertion is traumatic, requires continuous medical monitoring of a patient before and after the diagnostics or treatment.
  • transurethral and epicystostomic techniques of insertion of measuring catheters into the urinary bladder suffer a technical problem, which has not been still resolved.
  • transurethral and epicystostomic techniques of insertion of measuring catheters into the urinary bladder suffer a technical problem, which has not been still resolved.
  • This problem is that the measured intravesical pressure is responsive to a depth of catheter insertion into the bladder; the higher the catheter edge is located relative to the bladder top, the lower the measured pressure is, and vice versa, the lower the catheter edge is located, the higher the measured pressure is.
  • Epicystostomic insertion of the catheter does not provide a technical capability of an adequate and low-traumatic fixation of the epicystostomic catheter inside the urinary bladder to ensure that the catheter can be removed quickly after the pressure has been measured, as the catheter is suspended to the urinary bladder wall with catgut sutures to make it fixed, besides the risk of infection is remained due to permanent residence of catheters in the urinary bladder and their communication with the external environment.
  • catheters are inserted into the bladder to different levels, and pressure fluctuations, transmitted by the catheters, are picked up by the devices to which they are coupled by hydraulic, pneumatic or wired connection.
  • This known method of measuring the intravesical pressure is performed by the sensor with a battery cell and the pressure transmitter, which are both inserted endoscopically and sutured to the urinary bladder wall between the mucosa and the muscle tissue.
  • the intravesical pressure picked up by the sensor is transmitted by the transmitter and recorded by an external recorder, according to the prior art, on the arm of the patient.
  • This method involving endoscopic suturing and removing of the sensor with a battery cell and the transmitter is traumatic and does not provide a reliable, and, the most important, complete information about intravesical pressure over the entire volume of the urinary bladder, because the sensor is sutured in a definite place of the urinary bladder.
  • the proposed method of measuring the urinary bladder pressure and the device for implementing thereof overcome all above-mentioned drawbacks and allow measuring the intravesical pressure non-traumatically over the entire volume of the urinary bladder in its natural physiological state, thereby, providing wide opportunities for measuring the pressure and improved absolute accuracy of measurement results.
  • the essence of inventions lies in that the proposed method of measuring the intravesical pressure implies usage of a sensor with a battery cell and a pressure transmitter, floating on a surface of urinary bladder liquid inside a balloon the location of which is changed responsively to varying of the level of the urinary bladder liquid while transmitting the pressure of corresponding levels to the external recorder located outside the patient's body, thereby proving wide opportunities for measuring and high accuracy of measurement results.
  • Fig. l shows schematically transurethral 2 insertion of a deflated balloon 5, with a pressure sensor, a battery cell and a pressure transmitter 6 located inside it, into a urinary bladder 3 by a conductor 1 , with subsequent inflation of the balloon by a dispenser 7 through a tubular conductor 1 and a check valve 4 of the balloon 5, thereafter, the conductor 1 is disconnected from the check valve 4 by a backward motion and is removed from out of the urinary bladder.
  • Fig. 2 shows schematically the urinary bladder 3 and location of the balloon 5 filled with gas via the check valve 4, with the pressure sensor with a battery cell and the pressure transmitter 6 inside the balloon 5, floating on the surface of the urinary bladder 3 liquid.
  • the method of measuring urinary bladder pressure at different levels implemented by the device comprising the pressure sensor with a battery cell and the pressure transmitter for transmitting pressure to the external recorder located outside the patient's body, is performed as follows:
  • Example 1 The balloon 5, made of a flexible material, comprising the pressure sensor with a battery cell and the pressure transmitter 6 is connected via its check valve 4 to the tubular conductor 1 and inserted transurethral ly 2 in its deflated state into the urinary bladder 3. Then the balloon 5 is inflated with gas to a desired volume by the dispenser 7, for example, by a syringe, connected to the free end of the tubular conductor 1. The inflated balloon 5 prevents pulling out of the conductor 1 , thus the conductor 1 becomes disconnected from the check valve 4 and is drawn out, while the gas inflated balloon 5 keeps floating on the surface of the urinary bladder 3 liquid.
  • the pressure sensor with a battery cell and the pressure radio-transmitter 6 located in the balloon starts to transmit the intravesical pressure.
  • Example 2 gas is released from the balloon 5 by means of an endoscope, and the deflated balloon is then removed from the bladder 3.
  • Example 2 All steps of Example 1 are repeated, by the exception that the deflated balloon 5 is inserted into the urinary bladder 3 by the conductor 1 epicystostomically, i.e. by suprapubic puncture and/or by layered discission of the tissue from the skin to the urinary bladder 3 wall, and after the balloon 5 is inflated and the conductor 1 is removed, the excisions are sutured.
  • the balloon 5 may also be removed transurethral ly.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Physiology (AREA)
  • Measuring And Recording Apparatus For Diagnosis (AREA)

Abstract

The inventions relate to a medicine, in particular, to urology, and are intended for measuring a urinary bladder pressure in diagnostic and therapeutic procedures. A proposed method of measuring the urinary bladder 3 pressure is performed by a sensor with a battery cell and a pressure transmitter 6 located inside a balloon 5 which is inserted transurethral or epicystostomyically in its deflated state by a tubular conductor 1 connected to a check valve 4 of the balloon 5 with subsequent gas inflation of the balloon 5 by a dispenser 7. The tubular conductor 1 is disconnected from the check valve 4 by a backward motion and is removed out, and the balloon 5 keeps floating on a surface of the urinary bladder 3 liquid. Pressure values transmitted by the pressure transmitter 6 are received by an external recorder. After diagnostic and therapeutic procedures have been completed, gas is released from the balloon 5 by means of an endoscope, and the deflated balloon is then removed from the urinary bladder 3. The proposed method and the device for implementation thereof provide non-traumatically measuring of the intravesical pressure over the entire volume of the urinary bladder 3 in its natural physiological state synchronically with varying of the level of the urinary bladder 3 liquid.

Description

METHOD FOR MEASURING URINARY BLADDER PRESSURE AND
DEVICE FOR IMPLEMENTING THEREOF
The inventions relate to medicine and, in particular, to urology, and are intended for measuring the urinary bladder pressure in diagnostics and therapeutic procedures.
Pressure inside a urinary bladder, hereinafter referred to as "intravesical pressure", is a key indicator in diagnostics and treatment of such urological diseases as prostate adenoma, uroschesis, urinary incontinence, etc.
The method for measuring the intravesical pressure, performed by two techniques, using a known catheter, which could be considered as the closest prior art to the proposed techniques, is known from various information sources (UROFLOWMETRY/ E.L. Vishnevsky, D.Y. Pushkar, O.B. Laurent, V.V.Danilov, A.E. Vishnevsky .-M: Pechatny gorod,2004.-220 p.,p3(See Appendix
1)
According to the first transurethral technique,' the known catheter is inserted into the urinary bladder through the urethra, where it remains until the end of diagnostics or treatment that completely distorts natural conditions, is accompanied by obstruction and irritation of the urethra and impacts negatively on the effectiveness of the diagnostics or treatment.
According to the second epicystostomic technique, the catheter is inserted by the means of a suprapubic puncture and/or layered dissection of tissues from skin to urinary bladder wall, where it remains until the end of the diagnostics or treatment. This technique of the catheter insertion is traumatic, requires continuous medical monitoring of a patient before and after the diagnostics or treatment.
According to Russian and foreign authors, transurethral and epicystostomic techniques of insertion of measuring catheters into the urinary bladder suffer a technical problem, which has not been still resolved.
1) Traumatic insertion of measuring catheters into the urinary bladder. 2) Non - physiologic conditions of analysis, because the patient is subjected to live and work with the catheter inserted through the urethra and suprapubic stoma;
3) A constant threat of loss of the measuring catheters from the urinary bladder
4) The risk of infectious and inflammatory complications due to permanent residence of catheters into the urinary tract;
5) Inadequacy of obtained values to the true values, due to the fact, that the depth of catheter insertion into the urinary bladder influences on the measured value of intravesical pressure:
the higher the catheter edge is located relative to the bladder top, the lower the measured pressure is and vice versa. [Chappie C, MacDiarmid S., Patel A. Urodynamics made easy. - London: Elsevier, 2009! - 221 p. - P. 68 - 69];
6) Discrepancy of the patient's sensation during the analysis with his everyday complaints is caused by the fact, that catheters inserted by any method, mechanically irritate the bottom wall of the urinary bladder, and, thus, simulate sensations and / or complaints that are not specific for everyday life of the patient.
According to Russian and foreign authors, transurethral and epicystostomic techniques of insertion of measuring catheters into the urinary bladder suffer a technical problem, which has not been still resolved. This problem is that the measured intravesical pressure is responsive to a depth of catheter insertion into the bladder; the higher the catheter edge is located relative to the bladder top, the lower the measured pressure is, and vice versa, the lower the catheter edge is located, the higher the measured pressure is. Epicystostomic insertion of the catheter does not provide a technical capability of an adequate and low-traumatic fixation of the epicystostomic catheter inside the urinary bladder to ensure that the catheter can be removed quickly after the pressure has been measured, as the catheter is suspended to the urinary bladder wall with catgut sutures to make it fixed, besides the risk of infection is remained due to permanent residence of catheters in the urinary bladder and their communication with the external environment. For more accurate measuring of the intravesical pressure, catheters are inserted into the bladder to different levels, and pressure fluctuations, transmitted by the catheters, are picked up by the devices to which they are coupled by hydraulic, pneumatic or wired connection.
At present, a method of measuring the intravesical pressure by a sensor with battery cell and a pressure transmitter is known and is referred to as the closest prior art (Wireless Micromanometer System for Chronic Bladder Pressure Monitoring. Conference materials - INSS, 09# 1569182043 (See Annex 2).
This known method of measuring the intravesical pressure is performed by the sensor with a battery cell and the pressure transmitter, which are both inserted endoscopically and sutured to the urinary bladder wall between the mucosa and the muscle tissue. The intravesical pressure picked up by the sensor is transmitted by the transmitter and recorded by an external recorder, according to the prior art, on the arm of the patient.
This method involving endoscopic suturing and removing of the sensor with a battery cell and the transmitter is traumatic and does not provide a reliable, and, the most important, complete information about intravesical pressure over the entire volume of the urinary bladder, because the sensor is sutured in a definite place of the urinary bladder.
The proposed method of measuring the urinary bladder pressure and the device for implementing thereof overcome all above-mentioned drawbacks and allow measuring the intravesical pressure non-traumatically over the entire volume of the urinary bladder in its natural physiological state, thereby, providing wide opportunities for measuring the pressure and improved absolute accuracy of measurement results.
The essence of inventions lies in that the proposed method of measuring the intravesical pressure implies usage of a sensor with a battery cell and a pressure transmitter, floating on a surface of urinary bladder liquid inside a balloon the location of which is changed responsively to varying of the level of the urinary bladder liquid while transmitting the pressure of corresponding levels to the external recorder located outside the patient's body, thereby proving wide opportunities for measuring and high accuracy of measurement results.
Fig. l shows schematically transurethral 2 insertion of a deflated balloon 5, with a pressure sensor, a battery cell and a pressure transmitter 6 located inside it, into a urinary bladder 3 by a conductor 1 , with subsequent inflation of the balloon by a dispenser 7 through a tubular conductor 1 and a check valve 4 of the balloon 5, thereafter, the conductor 1 is disconnected from the check valve 4 by a backward motion and is removed from out of the urinary bladder.
Fig. 2 shows schematically the urinary bladder 3 and location of the balloon 5 filled with gas via the check valve 4, with the pressure sensor with a battery cell and the pressure transmitter 6 inside the balloon 5, floating on the surface of the urinary bladder 3 liquid.
The method of measuring urinary bladder pressure at different levels implemented by the device, comprising the pressure sensor with a battery cell and the pressure transmitter for transmitting pressure to the external recorder located outside the patient's body, is performed as follows:
Example 1. The balloon 5, made of a flexible material, comprising the pressure sensor with a battery cell and the pressure transmitter 6 is connected via its check valve 4 to the tubular conductor 1 and inserted transurethral ly 2 in its deflated state into the urinary bladder 3. Then the balloon 5 is inflated with gas to a desired volume by the dispenser 7, for example, by a syringe, connected to the free end of the tubular conductor 1. The inflated balloon 5 prevents pulling out of the conductor 1 , thus the conductor 1 becomes disconnected from the check valve 4 and is drawn out, while the gas inflated balloon 5 keeps floating on the surface of the urinary bladder 3 liquid. The pressure sensor with a battery cell and the pressure radio-transmitter 6 located in the balloon, starts to transmit the intravesical pressure. After diagnostics and treatment procedures have been completed, gas is released from the balloon 5 by means of an endoscope, and the deflated balloon is then removed from the bladder 3. Example 2. All steps of Example 1 are repeated, by the exception that the deflated balloon 5 is inserted into the urinary bladder 3 by the conductor 1 epicystostomically, i.e. by suprapubic puncture and/or by layered discission of the tissue from the skin to the urinary bladder 3 wall, and after the balloon 5 is inflated and the conductor 1 is removed, the excisions are sutured. The balloon 5 may also be removed transurethral ly.

Claims

Claims
1. A method of measuring urinary bladder pressure, the method comprising using a sensor with a battery cell and a urinary bladder pressure transmitter, characterized in that the measured pressure is transmitted by the sensor with the battery cell and the pressure transmitter both floating on the urinary bladder liquid surface inside a balloon the location of which is changed by varying the level of the urinary bladder liquid.
2. A device for implementing the method for measuring urinary bladder pressure, the device comprising a sensor with the battery cell and a pressure transmitter, characterized in that the sensor with the battery cell and the pressure transmitter are enclosed in a flexible inflatable balloon provided with a check valve detachably connected to a tubular conductor having its other end connected to a gas dispenser to inflate the balloon after it has been inserted into the urinary bladder.
PCT/RU2012/001074 2012-01-17 2012-12-17 Method for measuring urinary bladder pressure and device for implementing thereof WO2013109163A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU2012101539 2012-01-17
RU2012101539/14A RU2491893C1 (en) 2012-01-17 2012-01-17 Method for urinary bladder pressure measurement, and ao lobkaryov's and oa lobkaryov's apparatus for implementing it

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017017688A2 (en) 2015-07-29 2017-02-02 The Trendlines Group Ltd. Method and device for treatment of stress urinary incontinence (sui)
CN111345829A (en) * 2020-03-20 2020-06-30 中国科学院大学温州研究院(温州生物材料与工程研究所) Novel bladder pressure test device

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CN201820338U (en) * 2010-02-09 2011-05-04 王剑火 Urination alarm device
CN102144921A (en) * 2010-02-09 2011-08-10 王剑火 Bladder pressure probe

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WO2000054701A1 (en) * 1999-03-15 2000-09-21 Innoventions Inc. Intravesicular balloon
WO2005115245A1 (en) * 2004-05-28 2005-12-08 Dynaventions Inc. Intravesicular device
CN201820338U (en) * 2010-02-09 2011-05-04 王剑火 Urination alarm device
CN102144921A (en) * 2010-02-09 2011-08-10 王剑火 Bladder pressure probe

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017017688A2 (en) 2015-07-29 2017-02-02 The Trendlines Group Ltd. Method and device for treatment of stress urinary incontinence (sui)
US11007354B2 (en) 2015-07-29 2021-05-18 Continale Medical Pte. Ltd. Method and device for treatment of stress urinary incontinence (SUI)
CN111345829A (en) * 2020-03-20 2020-06-30 中国科学院大学温州研究院(温州生物材料与工程研究所) Novel bladder pressure test device
CN111345829B (en) * 2020-03-20 2023-06-16 中国科学院大学温州研究院(温州生物材料与工程研究所) Novel bladder pressure test device

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