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WO2025056914A1 - Cathéter d'urologie - Google Patents

Cathéter d'urologie Download PDF

Info

Publication number
WO2025056914A1
WO2025056914A1 PCT/GB2024/052384 GB2024052384W WO2025056914A1 WO 2025056914 A1 WO2025056914 A1 WO 2025056914A1 GB 2024052384 W GB2024052384 W GB 2024052384W WO 2025056914 A1 WO2025056914 A1 WO 2025056914A1
Authority
WO
WIPO (PCT)
Prior art keywords
pressure
catheter tube
pressure sensors
balloon
centre
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/GB2024/052384
Other languages
English (en)
Inventor
Eskinder SOLOMON
Michael JEFFRYES
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Guys and St Thomas NHS Foundation Trust
Original Assignee
Guys and St Thomas NHS Foundation Trust
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 Guys and St Thomas NHS Foundation Trust filed Critical Guys and St Thomas NHS Foundation Trust
Publication of WO2025056914A1 publication Critical patent/WO2025056914A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61B5/68—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
    • A61B5/6853—Catheters with a balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • 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
    • A61B5/6885—Monitoring or controlling sensor contact pressure
    • 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
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/043—Arrangements of multiple sensors of the same type in a linear array

Definitions

  • This specification relates to a device 100, method and system for measuring pressures applied to the urethra.
  • Surgery to treat SUI aims to increase the bladder outlet pressure by either bulking or supporting the urethra.
  • the autologous facial sling procedure achieves this by using a ribbon of fascial tissue as a sling to support the urethra.
  • Optimal sling tension is key to maximising treatment efficacy while minimising complications. If the sling is too loose, the urethral closure pressure is not adequate to prevent SUI. If the sling is too tight, the bladder must work hard to overcome the high urethral resistance to generate flow. This results in new-onset overactive bladder symptoms such as frequency, urgency, urge incontinence, incomplete bladder emptying and associated urinary tract infections.
  • the present specification relates to a device for measuring pressures applied to the urethra.
  • the device comprises a catheter tube comprising a proximal end and a distal end, and a balloon, located at the distal end of the catheter tube, wherein the balloon is configured to inflate to anchor the catheter tube in position when the device is in use.
  • the device further comprises one or more pressure sensors, distributed along the catheter tube, wherein the one or more pressure sensors are configured to measure external pressure applied to the catheter tube. By measuring the external pressure applied to the catheter tube, the device can be used to determine the tension of an autologous fascial sling during an autologous fascial sling procedure.
  • the one or more pressure sensors are distributed between the balloon and the centre of the catheter tube. In an embodiment, the one or more pressure sensors are positioned at regular intervals along the catheter tube, for example the one or more pressure sensors may be positioned at 1cm intervals. In an embodiment, the device may comprise six pressure sensors.
  • the one or more pressure sensors are configured to take realtime pressure measurements.
  • the balloon is configured to deflate such that the catheter tube can be removed when the device is not in use.
  • the balloon may have a capacity of 5ml.
  • the specification also provides for a computer implemented method comprising receiving one or more pressure measurements from one or more pressure sensors, wherein the one or more pressure sensors are distributed along a catheter tube and are configured to measure external pressure applied to the catheter tube.
  • the computer implemented method further comprises determining a location of a centre of pressure based on the one or more pressure measurements and the positions of the one or more pressure sensors.
  • determining the location of the centre of pressure comprises calculating the mean of the positions of the one or more pressure sensors weighted by the one or more pressure measurements.
  • the positions of the one or more pressure sensors are measured from a distal end of the catheter tube.
  • the method further comprises displaying the one or more pressure measurements and/or the location of the centre of pressure on a user interface.
  • the one or more pressure measurements may be received in real time, and the location of the centre of pressure may be calculated in real time.
  • the specification further provides for a system for measuring pressures applied to the urethra.
  • the system comprises a device, the device comprising a catheter tube comprising a proximal end and a distal end; a balloon, located at the distal end of the catheter tube, wherein the balloon is configured to inflate to anchor the catheter tube in position when the device is in use; and one or more pressure sensors, distributed along the catheter tube, wherein the one or more pressure sensors are configured to measure external pressure applied to the catheter tube.
  • the system further comprises data processing apparatus in communication with the device and configured to receive one or more pressure measurements from the one or more pressure sensors, and determine a location of a centre of pressure based on the one or more pressure measurements and the positions of the one or more pressure sensors.
  • system further comprises a microcontroller configured to obtain one or more pressure measurements from each of the one or more pressure sensors and to transmit said one or more pressure measurements to the data processing apparatus.
  • the system may also comprise a user interface configured to display the one or more pressure measurements and/or the location of the centre of pressure in real time.
  • Figure 1 shows a device according to the present specification
  • Figure 2 shows a close-up view of an inflated balloon according to the present specification
  • Figure 3 shows a pressure sensor array according to the present specification
  • Figure 4 shows the device of Figure 1 during use
  • Figure 5 depicts a computer implemented method for measuring a location of the centre of pressure according to the present specification
  • Figure 6 shows a system according to the present specification
  • Figure 7 shows an example screenshot of a user interface according to the present specification.
  • FIG. 1 shows a device 100 according to the present specification.
  • the device 100 comprises a catheter tube 101.
  • the catheter tube 101 is inserted through the urethra and into the bladder in order to drain the bladder.
  • the catheter tube 101 may comprise any suitable urinary catheter and may be made of any suitable material.
  • Example materials may include silicone, latex, or polyurethane.
  • the catheter tube 101 comprises a distal end 102 and a proximal end 103.
  • the distal end 102 is defined as the end of the catheter tube 101 that is closest to the bladder when the catheter is inserted into the urethra
  • the proximal end 103 is the end of the catheter tube 101 which protrudes externally from the urethra.
  • a balloon 104 is located at the distal end 102 of the catheter tube 101.
  • the balloon 104 is configured to inflate when the catheter is in position in the urethra.
  • the balloon 104 inflates inside the bladder and acts as an anchor to hold the catheter tube 101 in position and prevent accidental removal.
  • the catheter tube 101 may comprise two channels.
  • the first channel is configured to drain the bladder.
  • the second channel is configured to supply water to the balloon 104.
  • the water is drained from the balloon 104 via the second channel.
  • a valve is located at the proximal end 103 of the second channel to switch between supplying the balloon 104 with water and draining the balloon 104. In this way, the catheter tube 101 is held in position in the urethra in a repeatable manner.
  • a catheter of this type is referred to as a Foley catheter or an indwelling urinary catheter.
  • the balloon 104 may be made of any suitable material. Suitable materials include silicone and latex.
  • the balloon 104 may have a total volume of 5ml.
  • the device 100 further comprises an array of one or more pressure sensors 105 distributed along the catheter tube 101.
  • the one or more pressure sensors 105 may be located in any suitable positions along the length of the catheter tube 101. In an embodiment, the one or more pressure sensors 105 may be positioned at regular intervals along the catheter tube 101. Alternatively, the one or more pressure sensors 105 may be positioned at irregular intervals. For example, the spacing between sensors may be reduced close to the anticipated location centre of pressure. In an embodiment, the pressure sensors may be distributed close to the distal end 102 of the catheter tube 101, such as between the balloon 104 and the centre of the catheter tube 101.
  • the spacing between adjacent pressure sensors may be less than 2cm, such as less than 1cm, such as less than 0.5cm.
  • the device 100 may comprise multiple pressure sensors, such as more than two pressure sensors, such as more than five pressure sensors.
  • the device 100 may comprise six pressure sensors evenly distributed at 1cm intervals starting from the internal edge of the balloon 104 and working towards the centre of the catheter.
  • the one or more pressure sensors 105 are attached to a flexible printed circuit board (PCB) 301, and the device 100 is produced by fitting the PCB 301 to the catheter tube 101.
  • the device 100 may be produced by retrofitting the flexible PCB 301 comprising the one or more pressure sensors 105 into a standard Foley catheter.
  • the device 100 can be readily adopted into standard practice, because the clinical technique for inserting the catheter is unchanged.
  • Figure 4 shows the device 100 in use during the autologous fascial sling procedure. Although Figure 4 depicts a female anatomy, it will be appreciated that the device 100 is also suitable for use during male SUI surgery, such as male sling surgery.
  • the device 100 may be used in other types of urinary surgery, including any procedure with a mechanism of action which potentially increases urethral resistance.
  • the device 100 is inserted into the urethra, and the balloon 104 is inflated within the bladder to anchor the device 100 in position.
  • the device 100 is positioned such that the one or more pressure sensors 105 are able to measure the pressure applied to the urethra by the autologous fascial sling.
  • the tension of the autologous fascial sling is indirectly measured via the pressure applied to the urethra. As the tension of the sling increases a greater force will be applied to the urethra resulting in an increase in the pressure applied to the urethra. A decrease in tension would result in a decrease in pressure.
  • the one or more pressure sensors 105 record the pressure applied.
  • the inventors have found that there is a linear relationship between the tension of the sling and the pressure measured by the device 100. Therefore, by measuring the pressure applied to the urethra, the device 100 can be used to determine the tension of the autologous fascial sling. In this way, the device 100 may be used to quantify the optimum sling tension, which until now has been measured subjectively by surgeons.
  • the one or more pressure sensors 105 are configured to take real time pressure measurements. In this way, a surgeon can adjust the tension of the autologous fascial sling in real time during surgery, guided by the pressure measurements taken by the device 100.
  • Figure 5 depicts a computer implemented method for measuring a location of the centre of pressure. The method may be performed by a data processing apparatus, such as the data processing apparatus 601 described below.
  • the method comprises receiving one or more pressure measurements from one or more pressure sensors.
  • the one or more pressure sensors are the one or more pressure sensors 105 of the device 100.
  • a location of a centre of pressure is determined based on the one or more pressure measurements and the positions of the one or more pressure sensors.
  • determining the location of the centre of pressure comprises calculating the mean of the positions of the one or more pressure sensors weighted by the one or more pressure measurements. Other methods of calculating the centre of pressure may also be used.
  • the resolution of the location of the centre of pressure may be improved by reducing the spacing between the one or more pressure sensors 105. Additionally or alternatively, increasing the number of pressure sensors may also improve the resolution of the location of the centre of pressure.
  • the one or more pressure sensors 105 may be configured to take real time pressure measurements, and the location of the centre of pressure may be calculated in real time.
  • the method 500 may additionally comprise displaying 503 the pressure measurements and/or the location of the centre of pressure on a user interface.
  • the surgeon can adjust the tension of the autologous fascial sling in real time during surgery.
  • the surgeon can adjust the position of the autologous fascial sling during surgery based on the location of the centre of pressure.
  • the surgeon can respond in real-time to feedback from the device 100 presented via the user interface. In this way, the accuracy of both the tension and position of the autologous fascial sling can be improved, improving the efficacy of the surgery and reducing the risk of complications for the patient.
  • FIG. 6 shows a system 600 according to the present specification.
  • the system 600 comprises the device 100 and data processing apparatus 601, configured to perform the steps of the method 500.
  • the device 100 is in communication with the data processing apparatus 601.
  • the system further comprises a microcontroller 602 configured to obtain one or more pressure measurements from each of the one or more pressure sensors 105 and to transmit said one or more pressure measurements to the data processing apparatus.
  • the microcontroller 602 may be attached to the device 100 and configured to transmit the one or more pressure measurements to the data processing apparatus 601 via a Bluetooth connection.
  • the device 100 may be connected directly to the data processing apparatus 601, for example via a wired connection.
  • the system may also comprise a user interface 603.
  • the user interface 603 may be configured to display the one or more pressure measurements and/or the location of the centre of pressure in real time.
  • Figure 7 shows an example screenshot of the user interface 603.
  • the user interface 603 displays the pressure measured by each of the one or more pressure sensors as a continuous graph, with each pressure sensor identified by its distance from the balloon.
  • the user interface displays a representation of the device 100 (shown on the right-hand side of Figure 7). Colour mapping on the representation of the device provides a visual indication of the pressure applied to different parts of the catheter tube, with a stronger colour indicating a higher pressure.
  • the highest pressure is applied at the pressure sensor 3cm from the balloon. In this way, both the strength of the pressure applied and the location of the centre of pressure can be visualised in real-time whilst the surgery is being performed.
  • the data processing apparatus 601 can record the pressure measurements and the location of the centre of pressure for future reference and patient records. Furthermore, the data processing apparatus may be configured to record timestamps to mark events during the surgery, for example the start of tensioning of the sling.

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

Abstract

L'invention concerne un dispositif et un système de mesure de pressions appliquées à l'urètre. Le dispositif comprend un tube de cathéter comprenant une extrémité proximale et une extrémité distale ; un ballonnet, situé au niveau de l'extrémité distale du tube de cathéter, le ballonnet étant conçu pour se gonfler pour ancrer le tube de cathéter en position lorsque le dispositif est utilisé ; et un ou plusieurs capteurs de pression, répartis le long du tube de cathéter, le ou les capteurs de pression étant configurés pour mesurer une pression externe appliquée au tube de cathéter. La spécification concerne également un procédé mis en œuvre par ordinateur recevant une ou plusieurs mesures de pression provenant d'un ou de plusieurs capteurs de pression et déterminant un emplacement d'un centre de pression sur la base de la ou des mesures de pression et des positions du ou des capteurs de pression.
PCT/GB2024/052384 2023-09-13 2024-09-13 Cathéter d'urologie Pending WO2025056914A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB2313990.0A GB202313990D0 (en) 2023-09-13 2023-09-13 Urology catheter
GB2313990.0 2023-09-13

Publications (1)

Publication Number Publication Date
WO2025056914A1 true WO2025056914A1 (fr) 2025-03-20

Family

ID=88412852

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2024/052384 Pending WO2025056914A1 (fr) 2023-09-13 2024-09-13 Cathéter d'urologie

Country Status (2)

Country Link
GB (1) GB202313990D0 (fr)
WO (1) WO2025056914A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040068203A1 (en) * 2002-10-03 2004-04-08 Scimed Life Systems, Inc. Sensing pressure
US20100069784A1 (en) * 2008-09-16 2010-03-18 Blaivas Jerry G Urological medical device and method for analyzing urethral properties

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040068203A1 (en) * 2002-10-03 2004-04-08 Scimed Life Systems, Inc. Sensing pressure
US20100069784A1 (en) * 2008-09-16 2010-03-18 Blaivas Jerry G Urological medical device and method for analyzing urethral properties

Also Published As

Publication number Publication date
GB202313990D0 (en) 2023-10-25

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