WO2021021023A1 - Ensemble tube endotrachéal et dispositif accessoire associé - Google Patents

Ensemble tube endotrachéal et dispositif accessoire associé Download PDF

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Publication number
WO2021021023A1
WO2021021023A1 PCT/SG2020/050436 SG2020050436W WO2021021023A1 WO 2021021023 A1 WO2021021023 A1 WO 2021021023A1 SG 2020050436 W SG2020050436 W SG 2020050436W WO 2021021023 A1 WO2021021023 A1 WO 2021021023A1
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WO
WIPO (PCT)
Prior art keywords
endotracheal tube
pressure
tube assembly
lavage
accessory device
Prior art date
Application number
PCT/SG2020/050436
Other languages
English (en)
Inventor
Chee Mun Eric LOH
Jun Wei NEO
Original Assignee
Avir Medical Pte. Ltd.
Tan Tock Seng Hospital 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 Avir Medical Pte. Ltd., Tan Tock Seng Hospital Pte Ltd filed Critical Avir Medical Pte. Ltd.
Publication of WO2021021023A1 publication Critical patent/WO2021021023A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0445—Special cuff forms, e.g. undulated
    • A61M16/0447—Bell, canopy or umbrella shaped
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0454—Redundant cuffs
    • A61M16/0459—Redundant cuffs one cuff behind another
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0463—Tracheal tubes combined with suction tubes, catheters or the like; Outside connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0475—Tracheal tubes having openings in the tube
    • A61M16/0477—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids
    • A61M16/0479—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids above the cuff, e.g. giving access to the upper trachea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/021—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes operated by electrical means
    • A61M16/022—Control means therefor
    • A61M16/024—Control means therefor including calculation means, e.g. using a processor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0486—Multi-lumen tracheal tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0841—Joints or connectors for sampling
    • A61M16/0858—Pressure sampling ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027—Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3344—Measuring or controlling pressure at the body treatment site
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
    • A61M2205/3382—Upper level detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A61M2205/505—Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7518—General characteristics of the apparatus with filters bacterial

Definitions

  • the present disclosure generally relates to an endotracheal tube assembly and an accessory device thereto.
  • a disadvantage of the described system is that while there is periodic actuation of the system, the actual build-up of fluids within the respiratory tract is not detected, and the system may therefore not immediately activate the suction, notwithstanding high accumulation levels of fluids. This system therefore does not allow for the active management of the suction procedure. Furthermore, the accumulated fluids may not be effectively removed from the respiratory tract by the described system as it relies on a series of suction holes along the endotracheal tube to do so.
  • An object of the invention is to ameliorate one or more of the above- mentioned difficulties.
  • an endotracheal tube assembly for insertion within a trachea comprising: a tubing; a cuff portion carried by the tubing; a drainage channel having an end positioned relative to the cuff portion so as to be able to draw accumulated bodily fluid from the cuff portion; a pressure sensing channel having an end positioned relative to the cuff portion through which an air pressure within the trachea can be measured; wherein the drainage channel is connectable to at least one suction device configured to draw the accumulated bodily fluid from the cuff portion and trachea; and the pressure sensing channel is connectable to a pressure sensor for measuring the air pressure within the trachea.
  • the cuff portion may comprise a basin shaped cavity.
  • the drainage channel end may be located within the basin shaped cavity.
  • the pressure sensing channel end may be located within the basin shaped cavity.
  • the function of both the drainage or pressure sensing channel may be provided by a single channel within the endotracheal tube assembly.ln some embodiments, the endotracheal tube assembly may further comprise a lavage channel having an end positioned relative to the cuff portion to allow for lavage to be supplied to the bodily fluid accumulated on the cuff portion.
  • the endotracheal tube assembly may further comprise an integrative tube member located around the tubing and providing at least one lumen forming at least the pressure sensing channel of the endotracheal tube assembly.
  • the integrative tube member may further comprise a second said lumen for forming a lavage channel.
  • the integrative tube member may comprise an elongate body for substantially accommodating the tubing, said at least one lumen is formed by an internal passage extending through the body along a generally longitudinal axis of the body.
  • the integrative tube member may comprise a short collar shaped body for engaging the tubing, said at least one internal lumen being formed in part by an internal passage passing though the body, and an external lumen connected to the internal passage and extending from the body.
  • an accessory device for an endotracheal tube assembly comprising a microprocessor control unit (MCU); a pressure sensing arrangement comprising: at least one pressure sensor and a pressure sensing line connectable to a pressure sensing channel of the endotracheal tube assembly, the pressure sensor sensing an air pressure within a trachea through the pressure sensing line when in use; and a suction arrangement comprising a pump, a drainage line connectable to a drainage channel of the endotracheal tube assembly, the pump being adapted to apply a negative pressure to the drainage line for drawing bodily fluids from the trachea when in use, and a collection container for receiving the collected bodily fluid; wherein the MCU controls actuation of the pump as a function of the pressure readings from the pressure sensor.
  • MCU microprocessor control unit
  • the MCU may actuate the pump when the pressure difference over time within the trachea is above a user or pre-set value.
  • the MCU may actuate the pump when the air pressure within the trachea is above a user or pre-set value.
  • the suction arrangement further comprises a flow sensor for reading a flow rate of bodily fluid through the drainage line.
  • the accessory device may further comprise a lavage arrangement for supplying lavage to the endotracheal tube, comprising a lavage container, a lavage line connectable to the lavage channel of the endotracheal tube assembly, and a pump controlled by the MCU for delivering the lavage through the lavage line.
  • a lavage arrangement for supplying lavage to the endotracheal tube, comprising a lavage container, a lavage line connectable to the lavage channel of the endotracheal tube assembly, and a pump controlled by the MCU for delivering the lavage through the lavage line.
  • the lavage may be delivered through the lavage line when the measured flow rate though the drainage line is below a pre-set value.
  • the accessory device may further comprise a screen and input buttons connected to the MCU, the screen displaying a user interface for the accessory device, and user input controls for controlling the operation of the accessory device.
  • the screen may display data logged by the MCU including pressure data measured by the pressure sensor, and vacuum pressure data,
  • the pressure data and/or vacuum pressure data may be displayed as a graph and/or numerical values showing the measured pressure difference over time.
  • the data logged by the MCU can be accessed and displayed.
  • an automated suction system comprising an endotracheal tube assembly as described above, and an accessory device as described above.
  • Fig. 1 shows an endotracheal tube assembly, according to an embodiment of the disclosure
  • FIG. 2a shows an exemplary accessory device in association with the endotracheal tube assembly of Fig. 1
  • Fig. 2b shows the accessory device connected to the endotracheal tube assembly according to some embodiments of the disclosure
  • Fig. 3 shows a method of providing an accessory device in association with the endotracheal tube assembly of Fig. 1 , according to an embodiment of the disclosure.
  • FIG. 4 shows an automated suction system comprising an endotracheal tube assembly and accessory device according to another embodiment of the present disclosure
  • Figs. 5a and 5b respectively show a front perspective and rear perspective view of the accessory device of the system of Fig. 4;
  • Figs. 6a, 6b and 6c respectively show opposing side perspective views and a detailed view of an integrative tube member of the endotracheal tube assembly shown in Fig. 4;
  • Figs. 7a and 7b respectively show a side perspective view and detailed view of an integrative tube member according to a further embodiment of the present disclosure
  • Fig. 8 is a system diagram of the accessory device of Figs.4, 5a and 5b;
  • Fig. 9 is a component block diagram of the automated suction system of Fig. 4.
  • Fig. 10 shows an automated suction system comprising an endotracheal tube assembly and accessory device according to a further embodiment of the present disclosure.
  • FIG. 1 an endotracheal tube assembly 100 is shown, according to an embodiment of the disclosure.
  • the endotracheal tube assembly 100 can include a tubing 102, a cuff portion 104 and a drainage channel 108, according to an embodiment of the disclosure.
  • the cuff portion 104 may include a pressure cuff, such as an inflation type cuff, and is arranged to be inflated via inflation channel 110.
  • the tubing 102 can include a first end 102a and a second end 102b.
  • the first end 102a and the second end 102b can define the extremities of the tubing 102.
  • the first and second ends 102a/102b can be opposing ends of the tubing 102.
  • the tubing 102 can be in the form of an elongated structure.
  • the tubing 102 can be in the form of an elongated hollow structure.
  • the tubing 102 can be an elongated hollow structure made of clear polyvinyl chloride (PVC) or other suitable materials.
  • PVC polyvinyl chloride
  • the tubing 102 can be shaped and dimensioned in a manner so as to be capable of carrying the cuff portion 104.
  • the tubing 102 can be further shaped and dimensioned in a manner so as to be capable of carrying the drainage channel 108, in an embodiment of the disclosure.
  • the tubing 102 can yet be further shaped and dimensioned in a manner so as to be capable of carrying the inflation channel 110.
  • the drainage channel 108 can be carried by the tubing 102 in a manner so as to facilitate communication (e.g., of fluid/fluids) from the cuff portion 104.
  • the cuff portion 104 can, for example, correspond to a pressure cuff which can be configured provide suction and/or collect and retain fluid/fluids (e.g., nasopharyngeal secretions, saliva and/or vomitus).
  • fluid/fluids e.g., nasopharyngeal secretions, saliva and/or vomitus
  • the drainage channel 108 can, for example, correspond to a subglottic drainage catheter.
  • the drainage channel 108 can be carried by the tubing 102 in a manner so as to facilitate communication from the cuff portion 104.
  • the drainage channel 108 can be configured to facilitate communication, from the cuff portion 104 of the aforementioned collected and retained fluid(s). Specifically, collected fluid(s) can be drawn out of (i.e., communicated from) the cuff portion 104 via the drainage channel 108.
  • the drainage channel 108 can be carried by the tubing 102 in a manner so as to be positioned relative to the cuff portion 104 for communication of collected and retained fluid(s) from (i.e.
  • FIG. 2a shows an accessory device 200 for use with the endotracheal tube 100.
  • the device 200 includes a device receptacle 202 and a fluid collection cannister 204.
  • the device receptacle 202 includes a suction device 210, sensor 220 and a dilution fluid (lavage) container/cannister 230.
  • the device receptor 202 includes a first connector 202a configured to connect with the drainage channel 108 of the endotracheal tube 100 so as to provide a suction force for draining collected/retained fluid around the cuff 104.
  • the device receptor 202 includes a second connector 202b to direct drained fluid to the fluid collection cannister 204.
  • the fluid collection cannister 204 may include a cannister holder 206 to facilitate proper placement and alignment of the fluid collection cannister 204 with respect to the second connector 202b.
  • the drainage channel 108 may be removably attached to a suction device 210 via the first connector 202a.
  • the suction device 210 may include a vacuum pump.
  • the vacuum pump 210 can be operated to induce a high and quick suction pressure.
  • the suction device 210 may be portable to facilitate movement.
  • the drainage channel 108 may include or be connected to a pressure sensor 220, such as a pressure gauge, arranged to sense a fluid buildup around a vicinity of the pressure cuff 104.
  • the piezoelectric sensor operates to measure the air pressure within the trachea, the measured pressure increasing as more fluid is accumulated therein. The pressure difference over a period of time provides an indication of the level of accumulation of fluids during that period.
  • the suction device 210 is configured to activate/be activated upon detection of a pressure around the vicinity of the pressure cuff exceeding or equal to a predetermined threshold.
  • the predetermined threshold may be related to accumulated fluid volumes of 0.1 ml to 20 ml.
  • the drainage channel 108 may additionally be connected to a viscosity sensor (not shown) to detect a viscosity parameter of any fluid buildup in the vicinity of the pressure cuff.
  • the pressure sensor 220 comprises a connector.
  • the connector can be shaped and dimensioned as a syringe for interfacing with a port associated with the drainage channel to remove or minimize any buildup of fluids in the vicinity of the pressure cuff when in use.
  • the connector is configured to match the shape of a typical syringe with no leakage of pressure when retrofitting to the subglottic secretion drainage (SSD) port.
  • SSD subglottic secretion drainage
  • the drainage channel may be connected to a suction device via one or more ports.
  • the endotracheal tube assembly 100 will next be described in a context of its operation. After the endotracheal tube assembly 100 has been lodged within an individual’s trachea, the cuff portion 104 can be in contact with the trachea 202, defining a contact portion.
  • Fluid/Fluids 206 can be collected in the vicinity of the cuff portion 104. Specifically, fluid(s) can be collected by the cuff portion 104 on the inflated surface of the cuff portion 104. In an embodiment when the cuff portion 104 is inflated a basin structure may be formed and fluid may accumulate therein. Such a structure aids in collection and retention of fluid(s).
  • the pressure sensor 220 detects a corresponding pressure buildup. Once a particular pressure difference over time is reached, or the pressure reaches a particular threshold, the suction device 210 can be activated via a switch arranged in data communication with the pressure sensor 220. Examples of the switch include electronic switches such as transistors.
  • the suction device 210 Upon activation of the suction device 210, the suction device 210 produces a suction force to drain the fluid around the vicinity of the cuff portion 104 via the drainage channel 108. Fluid(s) 206 can be drawn out of the trachea 202 by manner of suction. Suction can be by manner of negative pressure.
  • the drainage channel 108 can be carried by the tubing 102 so as to be positionally optimal for the purpose of drawing fluid(s) 206 out of the trachea 202.
  • the drainage channel 108 can, for example, be positioned relative to the cuff portion 104 so as to be capable of drawing fluid(s) carried by the cuff 104 out of the trachea.
  • the present disclosure contemplates a combination of impeding flow of fluid(s) beyond the a predetermined threshold, and drawing fluid(s) out of the trachea (i.e., in association with the drainage channel 108) for minimizing the possibility of, for example, ventilator-associated pneumonia (VAP) from occurring (i.e., hence advantageously at least reducing/mitigating health related risk(s)).
  • VAP ventilator-associated pneumonia
  • the present disclosure may be used with a variety of endotracheal tubes 100.
  • the pressure cuff 104 may include a plurality of portions shaped and dimensioned to produce a negative pressure to assist in drainage of fluid buildup around the cuff 204.
  • an endotracheal tube 100 which can include a tubing 102, a cuff portion 104, and a drainage channel 108.
  • a method 300 in association with the endotracheal tube 100 is shown in accordance with an embodiment of the disclosure.
  • the method 300 can correspond to a method of retrofitting the endotracheal tube 100 with a pressure sensor and a suction device, according to an embodiment of the disclosure.
  • the method 300 can, in one embodiment, include any one of a first providing step 302, a second providing step 304, or any combination thereof.
  • the method 300 can include a first providing step 302, a second providing step 304.
  • the pressure sensor can be provided in the receptable of the endotracheal tube 100, within the drainage channel 108, or connected to a port of the drainage channel 108.
  • the suction device can be provided. Specifically, the suction device may be connected to a port of the drainage channel 108.
  • suction device 210 and the sensor device 220 may be integrated as one single unit.
  • ETT airway respiratory management equipment
  • a drainage channel such as a subglottic secretion drainage channel can also be attached above the pressure cuff of an ETT for the purpose of removing bodily fluids, typically via a syringe-like device, which is contemplated as one of the possible suction devices as long as the operation of the syringe can be automated.
  • the fluids are secreted from the mouth or gastric reflux from the stomach and can be accumulated over time. It is contemplated that other suction devices such as a medical aspirator may be used to draw bodily fluids through the mechanical action of a vacuum pump which create suction.
  • the disclosure envisages the capability of detecting bodily fluids accumulated on top of the pressure cuff of an ETT.
  • the ability of detection including but not limited to, sensing presence of fluid, level or volume of fluids, triggers a suction response to drain the fluids out.
  • Increasing suction force within a safe range of pressure can also be induced to remove fluids of higher viscosities.
  • saline or water may be introduced to dilute accumulated secretions in the event where an increasing suction force is unable to draw the fluids out of the trachea. For example, if suction force is applied by the suction device for a predetermined period and the pressure sensor detects insignificant drop in pressure, this may indicate that the accumulated fluid has a high level of viscosity. A specific volume of saline would be introduced through the SSD port into the site of secretion. Following which, a suction response will be delivered to draw the diluted fluids out.
  • the tubing 102 can be in the form of an elongated structure. It is further contemplated that the tubing 102 can be in the form of a flexible elongated structure.
  • the pressure sensor has been described as a means to detect a parameter (pressure) buildup around the cuff region, it is appreciable that other devices, including active or passive measurement devices or sensors, may be used to detect one or more parameters associated with fluid buildup in the vicinity or within the pressure cuff such as volume or height.
  • the devices may include mechanical and/or electrical parts.
  • Figs. 4 to 9 respectively show an automated suction system 350 according to another embodiment of the present disclosure.
  • the automated suction system 350 comprises an accessory device 351 and an endotracheal tube assembly 353 that can be functionally connected to the control accessory 351.
  • the endotracheal tube assembly 353 shown in Fig. 4 comprises an endotracheal tube 370, about which has been mounted an integrative tube member 372 which is shown in more detail in Figs. 6a to 6c.
  • the endotracheal tube 370 comprises tubing 371 with an upper/machine end 379, and an opposing lower/patient end 377. Supported on the tubing 371 adjacent the lower/patient end 377 is a concave primary cuff portion 373, and a secondary cuff portion 375 spaced long the tubing 371 , with the secondary cuff portion 375 located closer to the lower/patient end 377.
  • This endotracheal tube 370 is described in more detail in the Applicant’s International Application No.
  • the integrative tube member 372 as shown in Figs. 6a to 6c comprises an elongate body 390 which may typically be made from a flexible and soft material capable of retaining its original shape. Extending along the length of the body 390 is a slot 391 that provides access to an internal channel 392 extending through the length of the body 390. This allows the tubing 371 of the endotracheal tube 370 to be inserted into and substantially accommodated within the channel 392.
  • the slot 391 is provided with a cut out section 393 which acts as an attachment opening through which the endotracheal tube 370 can be accessed. This allows for a drainage line 385 from the accessory device 351 (see Fig.
  • an internal drainage channel which may for example be a subglottic drainage catheter located within the endotracheal tube 370.
  • the side of the body 390 opposite to the slot 391 can be provided with a slot 395 to allow for any other external channels from the endotracheal tube 370 to extend therefrom, and not be blocked by the integrative tube member 372 when mounted on the endotracheal tube 370.
  • the Applicant’s International Application No. PCT/SG2020/050178 provides further details of these internal channels, which can include an inflation channel for allowing the cuff portions 373,375 to be inflated after the endotracheal tube assembly 353 has been inserted in the trachea.
  • One or more internal lumens may extend in a generally longitudinal direction through the wall 396 of the integrative tube member 372.
  • two such internal lumens are provided in the integrative tube member 372, with the upper end 390a of the body 390 being provided with inlet ports 397,399 to the internal lumens.
  • These internal lumens respectively form a pressure sensing channel and lavage channel for the endoscopic tube assembly 353.
  • the inlet ports 397,399 allow for a pressure sensing line 383 and lavage line 381 extending from the accessory device 351 to be respectively connected to each port 397,399 as shown in Fig. 4.
  • the integrative tube member 372 is mounted on the endotracheal tube 370 with the lower end 390b of the body 390 located within the basin shaped cavity 373a of the concave primary cuff portion 373.
  • the internal lumens extend to the lower end 390b and are therefore in fluid communication with the basin shaped cavity 373a.
  • the internal lumens when joined with the pressure sensing and lavage lines 381 ,383 form a continuous fluid connection from the accessory device 351 to the primary cuff portion 373.
  • Fig. 7a and 7b shows an alternative embodiment of an integrative tube member 401 comprising a short collar shaped body 403 having an opening 404 provided on one side thereof.
  • the body 403 is made from a flexible material so that the tubing 371 of the endotracheal tube 370 can be inserted through the opening 404.
  • the body 403 can therefore act like a clip to hold in place on the integrative tube member 401 on the endotracheal tube 370.
  • the body 403 is provided with two internal lumens 409, 411 having inlet ports 413, 415 provided at an end of the body 403.
  • the opposing end of each internal lumen 409,411 is respectively connected to two external lumens 405 and 407.
  • This arrangement provides fluid communication from the inlet ports 413, 415 to the distal ends 417,419 of each external lumen 405,407.
  • the integrative tube member 401 can be installed on the endotracheal tube 370 with the distal ends 417, 419 of each external lumen 405,407 located within the basin shaped cavity 373a.
  • Adhesive means such as adhesive tape may be used to secure each external lumen 405,407 to the tubing 371 of the endotracheal tube 370.
  • Each internal lumen 409,411 when joined to the associated external lumen 405,407 respectively form a pressure sensing channel and lavage channel of the endotracheal tube assembly.
  • the inlet ports 413,415 can then be respectively connected to the pressure sensing and lavage lines 379,383 extending from the accessory device 351 to thereby provide a continuous fluid communication between the accessory device 351 and the primary cuff portion 373.
  • the integrative tube member 401 will therefore operate in the same manner as the integrative tube member 372 of the previously described endotracheal tube assembly 353.
  • integrative tube members 372,401 have been described being used on the endotracheal tube 370 having a concave cuff portion 373, it is to be appreciated that they could also be installed on a conventional endotracheal tube which may have a balloon shaped cuff portion similar to that shown in Fig. 1.
  • the accessory device 351 comprises a housing 355, within may be accommodated a microprocessor control unit (MCU) 517, a pressure sensor 509 for sensing the air pressure within the trachea, a motor pump 527 and valves 523 for drawing accumulated bodily fluids through the drainage line 385, a flow sensor 513 for sensing the flow rate of bodily fluids and/or the presence of said fluids passing through the drainage line 385, and a lavage pump 557 for pumping lavage as required to dilute the viscosity of the bodily fluids prior to collection if required.
  • the motor pump 527 can provide a negative pressure to the drainage line 385 to draw bodily fluids therethrough as a suction response.
  • the motor pump 527 can however also provide a positive pressure to the drainage line 385 if a blockage is detected or experienced within that drainage line 385.
  • the MCU 517 communicates with the sensors 509,513, motor pump 527 and lavage pump 557 to enable the appropriate response including the frequency and/or duration of the suction response and/or lavage delivery to be provided.
  • a removable collection canister 551 for receiving fluids drawn from the trachea may also be accommodated within the housing 355, The collection canister 551 may be attached to a filter for preventing bacterial contamination, and may be integrated level meter to prevent overflow therefrom.
  • a removable lavage container 553 may also be accommodated within the housing 355, and may contain water, saline or other lavage for pumping by the lavage pump 557.
  • the exterior of the housing 355 supports a screen 357 on one side thereof.
  • a user interface of the accessory device 351 may be displayed on the screen 357.
  • Input buttons 369 may be located adjacent the screen 357 to allow a user to input instructions to the control module 351.
  • the screen 357 may be a touch screen facilitating the input of instructions to the accessory device 351.
  • connection ports 370 which can for example be in to form of USB ports, are also provided on the housing 355. These connection ports 370 provide a connection to the microprocessor unit facilitating data sharing therefrom. It is also envisaged that alternative connection technologies such as WiFi or Bluetooth could be used to facilitate data sharing therefrom.
  • An on/off button 367 is also provided adjacent the screen 357.
  • the control accessory 351 can alternatively be either AC or DC powered.
  • the opposing side of the housing 355 is provided with a sub-housing 359 within which is accommodated the removeable collection canister 551 within which the extracted bodily fluids can be collected.
  • An end of the housing 355 is provided with three connectors 361 ,363,365 for respectively connecting to a lavage line 381 , pressure sensing line 383 and drainage line 385 as shown in Fig. 4.
  • the opposing end of the housing may be provided with a sub housing 360 for accommodating therein the removable lavage cannister 553 containing lavage used to dilute the accumulated bodily fluids when required.
  • Fig. 8 is a system diagram showing the operation of the accessory device 351.
  • the input data 501 to the accessory device 351 includes data from one or more pressure sensors 509 which sense the air pressure difference over time or a predetermined air pressure within the trachea thereby showing the fluid build-up 507 within the trachea.
  • a further input is data from one or more flow sensors 513, where the flow rate and/or presence of fluids are sensed during a suction response to thereby provide fluid monitoring 511 of that flow rate and/or fluid presence.
  • a control arrangement 503 takes into account and records input data from the pressure and flow sensors 509,513 and input data provided by ADC and drivers 519 in communication with the pump 527 and lavage system 531 , this data logging 515 undertaken by the MCU 517.
  • the data that is recorded includes the pressure and flow sensed by the pressure and flow sensors 509,513, and vacuum pressure data from the suction response 525 of the pump 527,
  • the control arrangement 503 also provides for both mechanical flow and pressure control 521 of control valves 523 within the accessory device 351.
  • the output 505 will be a suction response 525 to extract the accumulated fluids using the pump 527, and an optional fluid dilution 529 using the lavage system 532 to dilute the fluids prior to the suction response.
  • the MCU 519 uses the logged data to calculate and analyse air pressure changes within the trachea, and the volume, flow rate and/or viscosity of the bodily fluids being collected or to be collected.
  • the data recorded by the MCU 519 can be plotted over time in a visually-friendly manner (either as a graph or as numerical values) that can be displayed on the screen 357.
  • Fig. 9 is a block schematic diagram showing the various components of the automated suction system 350.
  • the accessory device 351 includes the MCU 519 which controls a number of components including the lavage pump 557 for pumping lavage from a lavage canister 553 and though the lavage line 381 connected to one of the inlet ports 397,399,413,415 of the integrative tube member 372,401.
  • the MCU 519 further controls the motor pump 527 and valves 523 that can apply a negative pressure to the drainage line 385, that may be connected to the subglottic drainage port 571 of the endotracheal tube 353. Accumulated bodily fluids then can be drawn up through the drainage channel 385 from the concave cuff portion 373.
  • the MCU 519 further controls and receives data from the flow sensor 513 that measures the flow rate of bodily fluids being drawn through the drainage channel 385 into a collection canister 551.
  • the flow meter 513 used herein is not restricted in type, and can for example include capacitive, ultrasonic, electromagnetic (hall effect), resistive or infrared sensors.
  • the MCU 519 further controls and receives data from a pressure sensor 509 that measures air pressure within the trachea via the pressure sensing channel 383 that when connected to the integrative tube member 372,401 mounted on the endotracheal tube 353.
  • the pressure sensor 509 is also not restricted in type and could for example include capacitive, optical, piezoelectric, and piezoresistive sensors.
  • the output signal from the pressure sensor 509 can be either analog or digital.
  • the user interface of the accessory device 351 is provided with a display screen 357, input buttons as for example shown in Fig. 5a.
  • the control accessory 351 is powered though a power supply 563 providing either AC or DC power.
  • the drainage channel and pressure sensing channel are described as two separate channels within the endotracheal tube assembly. It is however also envisaged that the function of both the drainage or pressure sensing channel be provided by a single channel 605 within the endotracheal tube assembly 353A as shown in Fig. 10..
  • the accessory device 351A would then be adapted to provide a single connection port 599 which may be in fluid connection with that single channel 605, and which can allow for both a suction response and pressure sensing using that single channel 605 via that single port 599.
  • a drainage/pressure sensing line 605 extends from the single port 599, and is connected via a connector 603 to the single channel 605.
  • Fig. 10 also shows an inflation channel 607 and negative pressure channel 609 from the endotracheal tube assembly 353A, the purpose of which are described in the Applicant’s International Application No. PCT/SG2020/050178.
  • processor and its plural form include microcontrollers, microprocessors, programmable integrated circuit chips such as application specific integrated circuit chip (ASIC), computer servers, electronic devices, and/or combination thereof capable of processing one or more input electronic signals to produce one or more output electronic signals.
  • the processor includes one or more input modules and one or more output modules for processing of electronic signals.

Abstract

L'invention concerne un ensemble tube endotrachéal (100, 353) destiné à être inséré à l'intérieur d'une trachée et comprenant : un tube (102, 371) ; une partie de manchon (104, 373) portée par le tube ; un canal de drainage (108) ayant une extrémité positionnée par rapport à la partie de manchon de façon à pouvoir aspirer le fluide corporel accumulé de la partie de manchon ; un canal de détection de pression (397, 399, 413, 415, 405, 407) ayant une extrémité positionnée par rapport à la partie de manchon à travers laquelle une pression d'air à l'intérieur de la trachée peut être mesurée ; le canal de drainage pouvant être relié à au moins un dispositif d'aspiration conçu pour aspirer le fluide corporel accumulé de la partie de manchon et de la trachée ; et le canal de détection de pression peut être relié à un capteur de pression pour mesurer la pression d'air à l'intérieur de la trachée.
PCT/SG2020/050436 2019-07-30 2020-07-29 Ensemble tube endotrachéal et dispositif accessoire associé WO2021021023A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SG10201907027P 2019-07-30
SG10201907027P 2019-07-30

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021252589A1 (fr) * 2020-06-09 2021-12-16 Pham Thach Appareil d'aspiration de lavage bronchique automatique synchronisé

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Publication number Priority date Publication date Assignee Title
US20160101253A1 (en) * 2014-10-08 2016-04-14 Husam Ibrahim ALAHMADI Protective endotracheal tube
US9474469B2 (en) * 2008-10-24 2016-10-25 Hospitech Respiration Ltd. Method and system for ventilation
US9750910B2 (en) * 2014-08-14 2017-09-05 Coeo Labs Private Limited Systems for automatically removing fluid from multiple regions of a respiratory tract
US20190060594A1 (en) * 2017-08-31 2019-02-28 Qscope, LLC Endotracheal tube drainage system and methods

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9474469B2 (en) * 2008-10-24 2016-10-25 Hospitech Respiration Ltd. Method and system for ventilation
US9750910B2 (en) * 2014-08-14 2017-09-05 Coeo Labs Private Limited Systems for automatically removing fluid from multiple regions of a respiratory tract
US20160101253A1 (en) * 2014-10-08 2016-04-14 Husam Ibrahim ALAHMADI Protective endotracheal tube
US20190060594A1 (en) * 2017-08-31 2019-02-28 Qscope, LLC Endotracheal tube drainage system and methods

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021252589A1 (fr) * 2020-06-09 2021-12-16 Pham Thach Appareil d'aspiration de lavage bronchique automatique synchronisé

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