[go: up one dir, main page]

WO2025014423A1 - Appareil et procédé de détermination de l'emplacement de l'extrémité distale d'un tube inséré dans une cavité corporelle - Google Patents

Appareil et procédé de détermination de l'emplacement de l'extrémité distale d'un tube inséré dans une cavité corporelle Download PDF

Info

Publication number
WO2025014423A1
WO2025014423A1 PCT/SG2023/050494 SG2023050494W WO2025014423A1 WO 2025014423 A1 WO2025014423 A1 WO 2025014423A1 SG 2023050494 W SG2023050494 W SG 2023050494W WO 2025014423 A1 WO2025014423 A1 WO 2025014423A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
tube
body cavity
distal end
microcontroller
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/SG2023/050494
Other languages
English (en)
Inventor
Johnny Chee
Puay Hian Goh
Xuezhen SONG
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.)
Biosense Diagnostics Pte Ltd
Original Assignee
Biosense Diagnostics Pte Ltd
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 Biosense Diagnostics Pte Ltd filed Critical Biosense Diagnostics Pte Ltd
Priority to PCT/SG2023/050494 priority Critical patent/WO2025014423A1/fr
Priority to TW113126139A priority patent/TW202517236A/zh
Publication of WO2025014423A1 publication Critical patent/WO2025014423A1/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
    • A61B5/68—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
    • A61B5/03—Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure ; Measuring pressure in body tissues or organs
    • A61B5/036—Measuring fluid pressure within the body other than blood pressure, e.g. cerebral pressure ; Measuring pressure in body tissues or organs by means introduced into body tracts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/008—Sensor means, e.g. for sensing reflux, acidity or pressure
    • A61J15/0088—Sensor means, e.g. for sensing reflux, acidity or pressure for sensing parameters related to the device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0431—Portable apparatus, e.g. comprising a handle or case
    • 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
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/168—Fluid filled sensor housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/70—Device provided with specific sensor or indicating means

Definitions

  • the present disclosure relates to an apparatus and method for determining location of a distal end of a tube inserted into a body cavity, and in particular to location of a distal end of a nasogastric tube for tube feeding a patient.
  • tubes In healthcare settings, tubes often need to be inserted into parts of a body (whether human or animal) for various reasons. Evidently, the tube needs to be correctly placed in order for it to be of use. If the distal end of the inserted tube is in a wrong location, therapeutic agents that are provided through the tube will be administered to a wrong part of the body and can cause harm.
  • NGT nasogastric tube
  • misdirection may occur and the distal end of the NGT may end up in the lungs or pleural space instead of the stomach, leading to pneumothorax, pneumonia and/or feed empyema if liquid food is poured into such a NGT.
  • sensors and devices include an ultrasound transducer, pH sensor, contact pressure sensor, continuity monitor, fluid pressure sensor, microphone, vibrator, and wave generator.
  • sensors it is not desirable to introduce sensors into the body to determine the distal end of the NGT, nor to have the sensors left inside for lengthy periods.
  • sensors must be made biologically robust and biocompatible to withstand the corrosion from body fluids such as stomach acid or antibodies from the body’s immunity system, thus driving up the cost of such sensors.
  • the present application discloses an apparatus and method for determining location of a distal end of a tube inserted into a body cavity. It can be used to determine the location of the distal end of an NGT before tube feeding commences. At all times, no part of the apparatus comes into contact with the body.
  • the disclosed apparatus and method introduce no sensors into the body and is compatible with standard tubes that are in common use.
  • the apparatus works for all patients, is readily portable, quick to set up and easy to operate. It allows for bedside point-of-care use and provide location confirmation within seconds. Issues with mess and contamination associated with drawing aspirate are avoided.
  • the apparatus is easy to clean and can be used with multiple patients without causing cross-contamination or producing any radiation, thereby reducing costs and posing no health risks.
  • an apparatus for determining location of a distal end of a tube inserted into a body cavity comprising: a sensing unit having a fluid outlet provided to form a fluid communication with a proximal end of the tube; a fluid chamber provided in the sensing unit in fluid communication with the fluid outlet; a fluid bolus valve provided in fluid communication between the fluid chamber and the fluid outlet, wherein upon activation of the fluid bolus valve when the proximal end of the tube is in fluid communication with the fluid outlet and the distal end of the tube is inserted into a body cavity, the fluid bolus valve is opened for a predefined period of time to release a fluid bolus having a predefined pressure and a predefined volume that travels from the fluid chamber through the tube into the body cavity; a backpressure sensor provided in fluid communication with the fluid outlet to measure, over a predetermined period of time, backpressure that arises as the fluid bolus is released from the distal end of the
  • the apparatus may further comprise a warning indicator provided on the sensing unit and activatable by the microcontroller to indicate a warning if the distal end of the tube is determined by the microcontroller to be not at the first predefined body cavity.
  • the apparatus may further comprise a second indicator provided on the sensing unit to indicate that the distal end of the tube is at a second predefined body cavity if so determined by the microcontroller.
  • the apparatus may further comprise a second switch provided on the sensing unit and activatable by a user to activate the fluid bolus valve, and wherein the warning indicator is further activatable by the microcontroller to indicate a warning if the distal end of the tube is determined by the microcontroller to be not at the second predefined body cavity.
  • the apparatus may further comprise a third indicator provided on the sensing unit and activatable by the microcontroller to indicate that location of the distal end of the tube is unknown if the distal end of the tube has been determined by the microcontroller to be neither at the first predefined body cavity nor at the second predefined body cavity.
  • the fluid may be air
  • the sensing unit further comprises a fluid inlet
  • the apparatus further comprises a pump provided in fluid communication between the fluid inlet and the fluid chamber to pump ambient air into the fluid chamber.
  • the apparatus may further comprise a chamber pressure sensor provided to determine a chamber air pressure of air in the fluid chamber, wherein the microcontroller is in communication with the chamber pressure sensor and the pump, and wherein the pump is controllable by the microcontroller to keep the chamber air pressure at a preset chamber air pressure.
  • the apparatus may further comprise a filter provided between the fluid inlet and the fluid chamber to filter the ambient air that is pumped into the fluid chamber.
  • the sensing unit may further comprise an exhaust outlet and wherein the fluid chamber is in fluid communication with the exhaust outlet via an exhaust valve configured to allow excess air to leave the fluid chamber when the chamber air pressure exceeds a predetermined safety pressure.
  • the apparatus may further comprise a cartridge attachable to the sensing unit and to which the proximal end of the tube is connectable, the cartridge having a fluid passage therethrough to establish a fluid connection between the fluid outlet of the sensing unit and the proximal end of the tube, wherein a valve is provided in the fluid passage to prevent backflow of fluid from the tube to the fluid outlet.
  • the apparatus may further comprise a connecting tube to establish a fluid connection between the cartridge and the proximal end of the tube.
  • the microcontroller may be in communication with the first switch and the fluid bolus valve, and is configured to control activation of the fluid bolus valve upon activation of the first switch by the user.
  • the microcontroller may be further configured to compare the obtained characteristics with predetermined characteristics of predetermined body cavities and to classify the location of the distal end of the tube according to the predefined body cavity of which the predetermined characteristics correlate with the obtained characteristics.
  • a method of determining location of a distal end of a tube inserted into a body cavity comprising the steps of:
  • step (e) may further comprise the microcontroller activating a first indicator provided to indicate that the distal end of the tube is at the first predefined body cavity.
  • step (e) may further comprise the microcontroller activating a second indicator provided to indicate that the distal end of the tube is at the second predefined body cavity.
  • step (e) may comprise the microcontroller activating a third indicator provided to indicate that the distal end of the tube is unknown.
  • the method may further comprise the microcontroller activating a warning indicator if step (a) was performed by activating a first switch and the location determined in step (d) is not the first predefined body cavity.
  • the method may further comprise the microcontroller activating the warning indicator if the location determined in step (d) is neither the first predefined body cavity nor the second predefined body cavity.
  • Step (a) may comprise releasing a plurality of fluid boli at predefined time intervals into the proximal end of the tube, and wherein step (b) comprises measuring the backpressure that arises as the plurality of fluid boli are released from the distal end of the tube into the body cavity.
  • the fluid may be air and the method may further comprise pumping ambient air into the fluid chamber to keep a chamber air pressure of air in the fluid chamber at a preset chamber air pressure.
  • the method may further comprise comprising filtering the ambient air that is pumped into the fluid chamber using a filter.
  • the method may further comprise allowing excess air to leave the fluid chamber via an exhaust valve when the chamber air pressure exceeds a predetermined safety pressure.
  • the method may further comprise, before step (a), providing a cartridge in fluid connection between the fluid outlet and the proximal end of the tube to prevent backflow of fluid from the tube to the outlet using a valve provided in the cartridge.
  • the method may further comprise, before step (a), establishing a fluid connection between the cartridge and the proximal end of the tube using a connecting tube.
  • Step (e) may comprise the obtained characteristics with reference characteristics of predetermined body cavities and classifying the location of the distal end of the tube according to the predefined body cavity where the reference characteristics correlate with the obtained characteristics.
  • FIG. 1 is a perspective view of an exemplary embodiment of a tube attached to an apparatus for determining location of a distal end of the tube when the tube is inserted into a body cavity.
  • FIG. 2 is a perspective view of exemplary components of the apparatus of FIG. 1 before assembly for use.
  • FIG. 3 is an exploded assembly view of a sensing unit of the apparatus of FIG. 1.
  • FIG. 4 is a close-up perspective view of some components within the sensing unit.
  • FIG. 5 is a top view of a first exemplary top surface of the sensing unit.
  • FIG. 6 is a top view of a second exemplary top surface of the sensing unit.
  • FIG. 7 is a top view of a third exemplary top surface of the sensing unit.
  • FIG. 8 is an exemplary backpressure profile obtained when the distal end of the tube is in the stomach.
  • FIG. 9 is a first exemplary backpressure profile obtained when the distal end of the tube is in the oesophagus.
  • FIG. 10 is a second exemplary backpressure profile obtained when the distal end of the tube is in the oesophagus.
  • FIG. 11 is a flowchart of an exemplary method of determining location of the distal end of the tube when the tube is inserted into a body cavity.
  • FIG. 12 is a schematic diagram of a fluid pathway and a signal pathway of the apparatus and method.
  • FIGS. 1 to 12 Exemplary embodiments of the apparatus 100 and method 200 for determining location of a distal end 301 of a tube 300 inserted into a body cavity (not shown) will be described with reference to FIGS. 1 to 12 in which the same reference numerals are used across the figures to refer to the same or similar parts.
  • the apparatus 100 comprises a sensing unit 10 having a fluid outlet 11 provided to form a fluid communication with a proximal end 302 of the tube 300.
  • the sensing unit 10 is preferably easily portable in one hand, and may have a cuboid form with a housing 14 enclosing various components therein, as shown in FIG. 3.
  • the proximal end 320 of the tube 300 may be directly connected to the fluid outlet 11.
  • the apparatus 100 may further comprise a cartridge 80 attachable to the sensing unit 10 and to which the proximal end 302 of the tube 300 is connectable.
  • the cartridge 80 has a fluid passage therethrough to establish a fluid connection between the fluid outlet 11 of the sensing unit 10 and the proximal end 302 of the tube 300.
  • An anti-backflow valve (not shown) is preferably provided in the fluid passage of the cartridge 80 to prevent backflow of fluid from the tube 300 to the fluid outlet 11.
  • the anti-backflow valve may be provided at the fluid outlet 11 on the sensing unit 10.
  • the housing 14 of the apparatus may include a cartridge receiver 48 configured to form a fluid-tight seal with the cartridge 80 while allowing fluid communication from the housing 14 to the cartridge 80.
  • the housing 14 and cartridge 80 are preferably made of a plastics material such as polycarbonate (PC), acrylonitrile butadiene styrene (ABS), or a mixture of PC and ABS, for example.
  • a connecting tube 90 may additionally be provided in the apparatus 100 to establish a fluid connection between the cartridge 80 and the proximal end 302 of the tube 300.
  • the connecting tube 90 may have a nozzle 91 provided at its distal end to facilitate connection with the proximal end 802 of the tube 300.
  • the connecting tube 90 would allow a fluid connection to be established between the sensing unit 10 and the proximal end 302 of the tube 300 that is at a distance away and closer to the patient in bed.
  • a fluid chamber 13 is provided in the sensing unit 10, as shown in FIG. 3.
  • the fluid chamber 13 is in fluid communication with the fluid outlet 11.
  • the fluid chamber 13 may be connected to the fluid outlet 11 via a chamber outlet tubing 13-2 for example, as shown in FIG. 4.
  • a fluid bolus valve 17 is provided in fluid communication between the fluid chamber 13 and the fluid outlet 11 , as shown in FIG. 4.
  • the fluid bolus valve 17 may be a solenoid valve, for example.
  • the fluid bolus valve 17 When the fluid bolus valve 17 is activated, the fluid bolus valve 17 is opened for a predefined period of time. This will release a fluid bolus (not shown) from the fluid chamber 13 to the fluid outlet 11.
  • the fluid bolus has a predefined pressure and a predefined volume that may be determined from the fluid pressure in the fluid chamber 13 and the predefined period of time during which the fluid bolus valve 17 is open.
  • the fluid bolus valve 17 is opened while the proximal end 302 of the tube 300 is in fluid communication with the fluid outlet 11 and the distal end 301 of the tube 300 is inserted into a body cavity, the released fluid bolus will travel from the fluid chamber 13 into the tube 300 and leave the distal end 301 of the tube 300 to enter the body cavity.
  • a backpressure sensor 19 is provided in the sensing unit 10 in fluid communication with the fluid outlet 11 (for example via a backpressure sensor tubing 19-1 as shown in FIG. 4).
  • the apparatus 100 also comprises a microcontroller 20 provided in the sensing unit 10 in communication with the backpressure sensor 19.
  • the microcontroller 20 is configured to generate a backpressure profile from the backpressure measured over the predetermined period of time.
  • FIG. 8 shows an exemplary backpressure profile obtained when the distal end 301 of the tube 300 was confirmed to be in a patient’s stomach (the stomach being an example of a body cavity) and the fluid bolus was released from the fluid chamber 13.
  • FIGS. 9 and 10 show exemplary backpressure profiles obtained from two patients when the distal end 301 of the tube 300 was confirmed to be in each patient’s oesophagus, the oesophagus being another example of a body cavity.
  • the backpressure profiles for the body cavity being the oesophagus both have significant initial peaks that drop sharply and then plateau, unlike the backpressure profile for the body cavity being the stomach (FIG.
  • backpressure profiles have been obtained from different known body cavities of multiple patients, and the specific characteristics from these backpressure profiles have been subsequently obtained.
  • reference characteristics that are specific to predefined body cavities have been obtained and can be used to determine the location of the distal end 301 of the tube 300 for most patients.
  • the reference characteristics are stored in a data storage unit (not shown) that is in communication with the microcontroller 20 before use of the apparatus 100.
  • the reference characteristics are stored when the apparatus 100 is being configured to specifically detect if the distal end 301 of the tube 300 is in one or more predefined body cavities.
  • the microcontroller 20 is configured to obtain the characteristics of the generated backpressure profile whenever the apparatus 100 is used, and to determine the location of the distal end 301 of the tube 300 according to the obtained characteristics. To do so, the microcontroller 20 may compare the characteristics obtained during use of the apparatus 100 with the stored reference characteristics and classify the location of the distal end 301 of the tube 300 as being in the predefined body cavity when the reference characteristics correlate with the obtained characteristics.
  • a chamber pressure sensor 16 is preferably provided in fluid connection with the fluid chamber 13 (for example via a chamber pressure sensor tubing 16-1 as shown in FIG. 4).
  • the sensing unit 10 further comprises a fluid inlet 99 and a pump 97 provided in fluid communication between the fluid inlet 99 and the fluid chamber 13 (for example via an inlet tubing 99-1 and a pump tubing 97-1 as shown in FIG. 4). In this way, ambient air can be drawn through the fluid inlet 99 and pumped into the fluid chamber 13 using the pump 97.
  • the microcontroller 20 is in communication with the chamber pressure sensor 16 and the pump 97.
  • the pump 97 is controlled by the microcontroller 20 to keep the chamber air pressure at a preset chamber air pressure.
  • a filter (not shown) may be provided between the fluid inlet 99 and the fluid chamber 13 to filter the ambient air that is pumped into the fluid chamber 13, so that the fluid bolus that is released into the body cavity comprises clean air.
  • an exhaust outlet 95 also may be provided in the sensing unit 10, wherein the fluid chamber 13 is in fluid communication with the exhaust outlet 95 via an exhaust valve 94 (for example via an exhaust outlet tubing 95-1 and an exhaust valve tubing 94-1 as shown in FIG. 4).
  • the exhaust valve 94 is in communication with the microcontroller 20 and is configured to be activated by the microcontroller to allow excess air to leave the fluid chamber 13 when the microcontroller 20 determines that the chamber air pressure (as measured by the chamber pressure sensor 16) exceeds a predetermined safety pressure.
  • a first switch 21 is provided on the sensing unit 10.
  • the first switch 21 is activatable by a user to activate the fluid bolus valve 17.
  • the first switch 22 may comprise a push button switch provided on a top surface 18 of the housing 14 of the sensing unit 10, as shown in FIGS. 1-3 and 5-7. In alternative embodiments, other switch types (not shown) may be used.
  • the first switch 21 is preferably connected to the microcontroller 20 so that when the first switch 21 is activated, the microcontroller 20 activates the fluid bolus valve 17 by opening the fluid bolus valve 17 for the predefined period of time. In this way, the fluid bolus that is released has the predefined pressure and predefined volume.
  • the fluid bolus may have a pressure ranging from 10 cmH 2 O to 100 cmH 2 O, and a volume ranging from 0.1 ml to 10 ml.
  • this can be controlled by the microcontroller based on the measurements of the chamber pressure sensor 16, the known size of the fluid outlet 11 and the predefined period of time for which the fluid bolus valve 17 is opened.
  • a first indicator 31 is also provided on the sensing unit 10, preferably also on the top surface 18 of the housing 14, as shown in FIGS. 1-3 and 5-7.
  • the first indicator 31 is connected to the microcontroller 20.
  • the microcontroller determines the body cavity that the distal end 301 of the tube 300 is in according to the obtained characteristics of the backpressure profile that has been generated. Also as described above, this may comprise the microcontroller 20 comparing the obtained characteristics with the reference characteristics of a first predefined body cavity, for example the stomach.
  • the reference characteristics have already been stored in a data storage unit (not shown) that is in communication with the microcontroller 20 before use of the apparatus 100.
  • the reference characteristics are stored when the apparatus 100 is being configured to specifically detect if the distal end 301 of the tube 300 is in the first predefined body cavity. If the microcontroller 20 determines that the distal end 301 of the tube 300 is indeed at the first predefined body cavity, the first indicator 31 is activated by the microcontroller 20 to provide this indication to the user, for example by lighting up if the first indicator comprises a light emitting diode (LED).
  • LED light emitting diode
  • the apparatus 100 may further include a warning indicator 33 provided on the sensing unit 10, preferably also on the top surface 18 of the housing 14.
  • the warning indicator 33 is connected to and activatable by the microcontroller 20 to indicate a warning if the distal end 301 of the tube 300 is determined by the microcontroller 20 to be not at the first predefined body cavity, for example by lighting up if the warning indicator 33 is an LED.
  • the apparatus 100 may further include a second indicator 32 provided on the sensing unit 10.
  • the apparatus 100 before use, is configured to specifically detect whether the distal end 301 of the tube 300 is in a first predefined body cavity (for example the stomach) or whether the distal end 301 of the tube 300 is in a second predefined body cavity (for example the oesophagus). This may comprise storing the reference characteristics of the first predefined body cavity and the reference characteristics of the second predefined body cavity in the sensing unit 10 before use of the apparatus 100.
  • the second indicator 32 is provided to indicate that the distal end 301 of the tube 300 is at the second predefined body cavity if so determined by the microcontroller 20 according to the obtained characteristics when the apparatus 100 is used.
  • the microcontroller 20 may be configured to activate the warning indicator 33 to indicate a warning if it 20 detects that the distal end 301 of the tube 300 is neither at the first nor the second predefined body cavity.
  • the apparatus 100 may further include a second switch 22 provided on the sensing unit 10, together with the second indicator 32 and the warning indicator 33.
  • the second switch 22 is configured to be activatable by a user to activate the fluid bolus valve 17 when the user wishes to determine if the distal end 301 of the tube 300 is at the second predefined body cavity.
  • the microcontroller 20 may be configured to activate the warning indicator 33 to indicate a warning if the distal end 301 of the tube 300 is determined by the microcontroller 20 to be not at the second predefined body cavity after the second switch 22 has been activated.
  • the first indicator 31 preferably also lights up together with the warning indicator 33.
  • the microcontroller 20 may be configured to activate the warning indicator 33 to indicate a warning if the distal end 301 of the tube 300 is determined by the microcontroller 20 to be not at the first predefined body cavity after the first switch 21 has been activated.
  • the microcontroller 20 may further be configured to activate the warning indicator 33 to indicate a warning if it 20 detects that the distal end 301 of the tube 300 is neither at the first nor the second predefined body cavity after either the first switch 21 or the second switch 22 is activated.
  • the top surface 18 of the housing 14 may comprise a membrane switch panel 18 in which the switches and indicators of the sensing unit 10 are provided.
  • the switches and indicators are protected by a waterproof membrane of the membrane switch panel 18 that serves as a user interface of the apparatus 100.
  • a power switch 29 is also provided on the top surface 18 of the housing 14 to turn on the sensing unit 10, although in other embodiments the first switch 21 can also be configured to additionally function as a power switch besides functioning to activate the fluid bolus valve 17.
  • the microcontroller 20, the valves 17, 94, the pressure sensors 16, 19 and the fluid pump 97 may be provided on a printed circuit board 40 provided in the housing 14, as shown in FIGS. 3 and 4.
  • the switches 21 , 22, 29 and indicators 31 , 32, 33 provided on the top surface 18 of the housing 14 may be connected to the PCB 40 in order to be in communication with the microcontroller 20.
  • FIG. 11 shows an exemplary embodiment of the method 200 for determining location of the distal end 301 of the tube 300 inserted into a body cavity.
  • FIG. 13 shows a fluid pathway and a signal pathway showing how fluid and signals flow through the various components of the apparatus 100 when the method 200 is performed.
  • the method 200 comprises first releasing at least one fluid bolus having a predefined pressure and a predefined volume from the fluid chamber 13 into the proximal end 302 of the tube 300 (201). This occurs when the user activates the first switch 21.
  • the method 200 comprises measuring, using the backpressure sensor 19, over a predetermined period of time, backpressure that arises as the at least one fluid bolus is released from the distal end 301 of the tube 300 into the body cavity (202).
  • the method 200 next comprises generating, using the microcontroller 20, a backpressure profile from the measured backpressure (203).
  • the method 200 comprises obtaining, using the microcontroller 20, characteristics of the generated backpressure profile (204).
  • indicating the location (206) encompasses indicating a warning if the distal end 301 of the tube 300 is determined to be not at a predefined body cavity that the apparatus 100 has been specifically configured to detect.
  • the location of the distal end 301 of the tube 300 can be quickly determined and indicated to a user, in a matter of seconds.
  • the apparatus 100 provides a user-friendly, point-of-care location determination of the distal end 301 of the tube 300 without requiring use of x-ray or drawing of aspirate in the case where the tube 300 is an NGT. In this way, the patient is not exposed to any harmful radiation, and no additional foreign materials are introduced into the patient as all components of the apparatus 100 do not come into contact with the patient at any time during use.
  • the apparatus 100 can be configured to determine multiple different body cavities into which a tube may be inserted, by storing the reference characteristics of these multiple different body cavities for comparison against the characteristics that are obtained during use of the apparatus 100 and providing the requisite indicators to show when the distal end 301 of the tube 300 has been determined to be at a specific body cavity.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Hematology (AREA)
  • Human Computer Interaction (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un appareil pour déterminer l'emplacement d'une extrémité distale d'un tube inséré dans une cavité corporelle, l'appareil comprenant : une unité de détection dotée d'une sortie de fluide destinée à former une communication fluidique avec une extrémité proximale du tube ; une chambre de fluide disposée dans l'unité de détection en communication fluidique avec la sortie de fluide ; une valve de bolus de fluide disposée en communication fluide entre la chambre de fluide et la sortie de fluide, la valve de bolus de fluide, activée lorsque l'extrémité proximale du tube est en communication fluide avec la sortie de fluide et que l'extrémité distale du tube est insérée dans une cavité corporelle, étant ouverte pendant une période prédéfinie pour libérer un bolus de fluide à une pression prédéfinie et un volume prédéfini qui se déplace de la chambre à fluide à travers le tube dans la cavité corporelle ; un capteur de contre-pression disposé en communication fluidique avec la sortie de fluide pour mesurer, sur une période prédéterminée, la contre-pression qui se produit lorsque le bolus de fluide est libéré de l'extrémité distale du tube dans la cavité corporelle ; un microcontrôleur disposé en communication avec le capteur de contre-pression et configuré pour générer un profil de contre-pression à partir de la contre-pression mesurée, le microcontrôleur étant en outre configuré pour obtenir des caractéristiques du profil de contre-pression généré et pour déterminer l'emplacement de l'extrémité distale du tube en fonction des caractéristiques obtenues ; un premier commutateur disposé sur l'unité de détection et pouvant être activé par un utilisateur pour activer la valve de bolus de fluide ; et un premier indicateur situé sur l'unité de détection pour indiquer la présence de l'extrémité distale du tube dans une première cavité corporelle prédéfinie, si elle est déterminée par le microcontrôleur.
PCT/SG2023/050494 2023-07-13 2023-07-13 Appareil et procédé de détermination de l'emplacement de l'extrémité distale d'un tube inséré dans une cavité corporelle Pending WO2025014423A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/SG2023/050494 WO2025014423A1 (fr) 2023-07-13 2023-07-13 Appareil et procédé de détermination de l'emplacement de l'extrémité distale d'un tube inséré dans une cavité corporelle
TW113126139A TW202517236A (zh) 2023-07-13 2024-07-12 決定插入主體空腔的管狀物遠端位置之方法以及裝置

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/SG2023/050494 WO2025014423A1 (fr) 2023-07-13 2023-07-13 Appareil et procédé de détermination de l'emplacement de l'extrémité distale d'un tube inséré dans une cavité corporelle

Publications (1)

Publication Number Publication Date
WO2025014423A1 true WO2025014423A1 (fr) 2025-01-16

Family

ID=94215829

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SG2023/050494 Pending WO2025014423A1 (fr) 2023-07-13 2023-07-13 Appareil et procédé de détermination de l'emplacement de l'extrémité distale d'un tube inséré dans une cavité corporelle

Country Status (2)

Country Link
TW (1) TW202517236A (fr)
WO (1) WO2025014423A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015136540A1 (fr) * 2014-03-13 2015-09-17 Art Healthcare Ltd. Mise en place et/ou suivi d'une sonde d'alimentation naso-/oro-gastrique par mesure combinée
US20180042819A1 (en) * 2015-03-13 2018-02-15 Brigham And Women's Hospital, Inc. Systems and Methods for Self-Detection Positioning of Nasogastric Tubes, Feeding Tubes, or Other Tubes
US20210030480A1 (en) * 2019-07-30 2021-02-04 Avent, Inc. Medical Device Position Notification System
WO2021202266A1 (fr) * 2020-03-30 2021-10-07 Mary Ann Winter Associates, Inc. Appareil et méthode pour guide d'insertion de sonde naso-gastrique
US20220011146A1 (en) * 2020-07-10 2022-01-13 Avent, Inc. Airway Detection Using Air Pressure Differential
US20220062574A1 (en) * 2020-08-31 2022-03-03 Avent, Inc. System and Method for Real-Time Carbon Dioxide and Pressure Sensing to Verify Placement of Tube in Airway or Esophagus

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015136540A1 (fr) * 2014-03-13 2015-09-17 Art Healthcare Ltd. Mise en place et/ou suivi d'une sonde d'alimentation naso-/oro-gastrique par mesure combinée
US20180042819A1 (en) * 2015-03-13 2018-02-15 Brigham And Women's Hospital, Inc. Systems and Methods for Self-Detection Positioning of Nasogastric Tubes, Feeding Tubes, or Other Tubes
US20210030480A1 (en) * 2019-07-30 2021-02-04 Avent, Inc. Medical Device Position Notification System
WO2021202266A1 (fr) * 2020-03-30 2021-10-07 Mary Ann Winter Associates, Inc. Appareil et méthode pour guide d'insertion de sonde naso-gastrique
US20220011146A1 (en) * 2020-07-10 2022-01-13 Avent, Inc. Airway Detection Using Air Pressure Differential
US20220062574A1 (en) * 2020-08-31 2022-03-03 Avent, Inc. System and Method for Real-Time Carbon Dioxide and Pressure Sensing to Verify Placement of Tube in Airway or Esophagus

Also Published As

Publication number Publication date
TW202517236A (zh) 2025-05-01

Similar Documents

Publication Publication Date Title
AU2023200628B2 (en) Systems, devices and methods for draining and analyzing bodily fluids
JP7688035B2 (ja) 体液の排出および分析並びに健康状態を評価するためのシステム、装置、および方法
US8631683B2 (en) Dialysis systems including non-invasive multi-function sensor systems
US8016798B2 (en) Fluid delivery system and sensing unit therefor
JP7091240B2 (ja) モニタリング能力を含むカテーテルアセンブリ
CN106902406B (zh) 磁性传感器及相关系统和方法
CN205796164U (zh) 用于检测液体流路中的气泡的泵匣盒主体和系统
CN103874522B (zh) 压力调节注射器及其方法
EP3496622B1 (fr) Aspirateurs à testeurs colorimétriques en ligne
CN112469453B (zh) 具有感测器并被配置用于诊断腹膜炎的腹膜透析系统
US20080103445A1 (en) Method and Apparatus for Detecting Air Bubbles
US20090187164A1 (en) Nasogastric tube placement and monitoring system
JP2017536857A (ja) 生理学的データを感知し、体液を排出しかつ分析するためのシステム、デバイス、および方法
CN103313740A (zh) 压力传感器及其使用方法
CN205073362U (zh) 微型负压吸引器
CN104840366A (zh) 一种营养饲管
WO2014078751A1 (fr) Suivi de respiration pour la trachéostomie
JP2024050587A (ja) 患者ラインの再使用を検出するための圧力測定の利用
WO2025014423A1 (fr) Appareil et procédé de détermination de l'emplacement de l'extrémité distale d'un tube inséré dans une cavité corporelle
US20220355018A1 (en) Devices and methods for managing chest or wound drainage
US10646629B2 (en) Pleural manometry catheter
US20130310770A1 (en) Infusion Apparatus With Composition Pulse Flow Sensor
CN215309032U (zh) 血管造影注射系统
CN222605026U (zh) 一种可检测插入位置的新型电导率胃管
US20090093786A1 (en) Method for detecting the occlusion of a tubing for a device for administering physiological liquids

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 23945255

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: AU2023454501

Country of ref document: AU