WO2012131626A2 - Ballooned ventilation tube cleaning device - Google Patents

Ballooned ventilation tube cleaning device Download PDF

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Publication number
WO2012131626A2
WO2012131626A2 PCT/IB2012/051532 IB2012051532W WO2012131626A2 WO 2012131626 A2 WO2012131626 A2 WO 2012131626A2 IB 2012051532 W IB2012051532 W IB 2012051532W WO 2012131626 A2 WO2012131626 A2 WO 2012131626A2
Authority
WO
WIPO (PCT)
Prior art keywords
main body
suction
fluid
balloon
ventilation tube
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.)
Ceased
Application number
PCT/IB2012/051532
Other languages
English (en)
French (fr)
Other versions
WO2012131626A3 (en
Inventor
Elad Einav
Oron Zachar
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.)
Airway Medix Sp zoo
Original Assignee
Airway Medix Sp zoo
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
Priority claimed from PL396436A external-priority patent/PL396436A1/pl
Priority claimed from GBGB1119794.4A external-priority patent/GB201119794D0/en
Application filed by Airway Medix Sp zoo filed Critical Airway Medix Sp zoo
Priority to EP19163574.7A priority Critical patent/EP3572112B1/en
Priority to EP12719067.6A priority patent/EP2714168B1/en
Priority to AU2012235744A priority patent/AU2012235744A1/en
Priority to CN201290000559.9U priority patent/CN204208149U/zh
Priority to JP2014501798A priority patent/JP2014527412A/ja
Priority to US14/008,558 priority patent/US10322253B2/en
Priority to US13/806,958 priority patent/US8999074B2/en
Priority to JP2014526598A priority patent/JP6122435B2/ja
Priority to PCT/IL2012/000320 priority patent/WO2013030821A1/en
Priority to BR112014004602-6A priority patent/BR112014004602A2/pt
Priority to EP12828334.8A priority patent/EP2809382B1/en
Priority to AU2012303609A priority patent/AU2012303609A1/en
Publication of WO2012131626A2 publication Critical patent/WO2012131626A2/en
Publication of WO2012131626A3 publication Critical patent/WO2012131626A3/en
Anticipated expiration legal-status Critical
Priority to US14/596,905 priority patent/US20150133864A1/en
Priority to US14/993,757 priority patent/US10143814B2/en
Priority to US15/069,150 priority patent/US10328224B2/en
Priority to US15/377,575 priority patent/US20170106160A1/en
Priority to AU2017204274A priority patent/AU2017204274A1/en
Priority to US16/443,755 priority patent/US10806884B2/en
Priority to US16/450,936 priority patent/US20190381266A1/en
Priority to US17/074,006 priority patent/US20210128856A1/en
Ceased legal-status Critical Current

Links

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. ventilators; 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. ventilators; Tracheal tubes
    • A61M16/0057—Pumps therefor
    • 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. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0436—Special fillings therefor
    • A61M16/0438—Liquid-filled
    • 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. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • A61M16/0454—Redundant cuffs
    • A61M16/0456—Redundant cuffs one cuff within 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. ventilators; 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. ventilators; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • 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. ventilators; 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. ventilators; 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
    • A61M16/0481—Tracheal tubes having openings in the tube with incorporated means for delivering or removing fluids through the cuff wall
    • 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. ventilators; 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/77—Suction-irrigation systems
    • 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. ventilators; 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
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/10—Equipment for cleaning

Definitions

  • Ventilation-tube-inner-surface-contacting width-expanded wiping element e.g. inflated balloon
  • the fluid delivery and the suction orifice(s) may respectively stream fluid into and suction material out of the more proximal portion of the interstitial region.
  • substantially no suction or suction at a significantly lower proximal air flow rate than the suction of step C is applied to locations distal of the slidable boundary.
  • the suction-orifice-displacement-value is at most 2 cm or at most 1 cm or at most 0.5 cm.
  • boundary- forming balloon 588 is mounted to the main body 210 at a location in a distal half (or third or quarter or fifth or tenth) of the main body 210.
  • longitudinal motion of the flexible main body 210 induces longitudinal motion of the fluid delivery orifice(s); II. is located proximal to the slidable boundary when the boundary forming balloon 558 is inflated to form the slidable bonudary;
  • proximal fluid delivery port 827 in fluid communication with proximal interior location 829 within fluid delivery lumen(s) 520 that is proximal to the connector assembly 158, the proximal fluid delivery port 827 being configured, when directly or indirectly connected to the source of pressurized fluid (e.g. 602 or other example(s)), to mediate a substantially fluid-tight (e.g.
  • ii. is(are) mechanically coupled to flexible main body 210 so that longitudinal motion of the flexible main body 210 induces longitudinal motion of the fluid delivery orifice(s) 525; iii. is located proximal to the slidable boundary when the boundary- forming balloon 558 is inflated to form the slidable boundary and is longitudinally displaced from the slidable boundary by at most 2 cm.
  • Some embodiments of the present invention relate to a wiping device for cleaning an inner surface of a ventilation tube in a closed ventilation system where an oxygen- including gas (e.g. air) is mechanically forced into the ventilation tube by an external ventilator.
  • the wiping device includes an elongate flexible main body, an width- expandable wiping element (e.g. an inflatable balloon), one or more suction orifice(s) and one or more fluid delivery orifice(s).
  • a wiping operation In order to clean an inside surface of a ventilation tube, it is possible to carry out (e.g. simultaneously or in any order) a wiping operation, a fluid delivery operation and a suction operation.
  • the width- expanded wiping element e.g. the inflated balloon
  • the ventilation tube inner surface e.g. biofilm
  • stream(s) of fluid e.g.
  • flexible, elongate main body 210 slidably and snugly passes through the interior of ventilation tube connector assembly 158 in a manner that does not substantially break the substantially air-tight connection between the ventilator machine 900 and the interior of the ventilation tube 60.
  • the systems 600A-C of FIGS. 4-16 all include an inflatable 'boundary-forming balloon' 588, mounted to the flexible main body 200.
  • proximal 774 and distal 778 portions of the interior of ventilation tube 60.
  • this slidable 'boundary; between proximal 774 and distal 778 portions is useful for facilitating the cleaning of the inner surface 201 - for example, for substantially confining locations of negative pressure and/or fluid (e.g.
  • fluid delivery orifice(s) 525 located on the surface of the second balloon 550 - for example, as voids or holes in the surface of the second balloon 550. This is not a limitation, and in the examples of FIGS. 8 and 16 alternative configurations are illustrated.
  • At least a portion 598 of elongate main body 210 is located proximal to ventilation tube connector assembly 158.
  • the magnitude of this 'portion' may depend on an extent to which distal end 208 and/or balloon 588 is deployed within ventilation tube 60 and/or an extent to which distal end 208 and/or balloon 588 is longitudinally displaced from ventilation tube connector assembly 158 - for example, an extent to which the main body 210 slides through ventilation tube connector assembly 158 in a distal direction.
  • a distal end 908 of sleeve 610 is (i) directly or indirectly attached to and/or (ii) has a location that is fixed and/or longitudinally fixed relative to ventilation tube connector assembly 158.
  • a longitudinal position of a location of a distal end 908 of sleeve 610 corresponds to a location on ventilation tube connector assembly 158 (e.g. at or near main body inlet 640) and/or is longitudinally displaced from a proximal end (e.g.
  • this may obviate the need to provide a source of pressurized liquid.
  • a source of pressurized gas or pressurized gas/liquid mixture 692 and (ii) a source of liquids (i..e. pressurized or unpressurized) or liquid- gas mixture.
  • FIG. 5 is a close-up view of locations near distal end 208 of main body 210 in some embodiments and in some configurations.
  • Inflatable balloon 588, suction orifice(s) 440 and fluid delivery orifice(s) are all visible close to the distal end 208 of main body 210.
  • FIG. 6 illustrates the distal end of main body 210 after insertion into ventilation tube 60 having an inner surface 201.
  • inflatable balloon 588 divides the region of space within the ventilation tube 60 but outside of main body 210 into two regions:
  • a pressurized liquid 525 may enter, via the fluid delivery orifice(s) 525 into '"the more proximal portion of the region within the ventilation tube and outside of main body' 774 of the interstitial region proximal to inflatable balloon 588 (for example, when balloon 588 is inflated into contact and/or so as to obstruct).
  • main body 210 may be true any position of main body 210 relative to an enclosing tube - e.g. a "reference" cylindrical tube having an inner diameter that is at least 4 mm or at least 6 mm and/or at most 12 mm or at most 10 mm or at most 8 mm.
  • an enclosing tube - e.g. a "reference" cylindrical tube having an inner diameter that is at least 4 mm or at least 6 mm and/or at most 12 mm or at most 10 mm or at most 8 mm.
  • size features of the enclosing tube - e.g.
  • FIGS. 7A-7B are not limited to embodiments of FIG. 6, and may relate to the any other embodiment.
  • delivering a stream of fluid with sufficient momentum to be incident upon inner surface 201 of ventilation tube 60 may be useful for mechanically dislodging biofilm temporarily attached to the ventilation tube inner surface 201 and/or chemically interacting with the biofilm in order to reduce any forces causing the biofilm to adhere to inner surface 201.
  • fluid delivery orifice(s) 525 is supplied with pressurized liquid (e.g. from liquid source 602) via fluid delivery lumen(s) 520.
  • pressurized liquid received via fluid delivery lumen(s) 520 also functions to inflate second balloon 586.
  • second balloon 586 is inflatable.
  • second balloon 586 is not required to be inflatable.
  • main body 588 within main tube 210) to cause contact with an enclosing ventilation tube 60 and/or to Obstruct flow' with the aforementioned 'reference' enclosing tube having an inner diameter of at least 4 mm or at least 6 mm and/or at most 12 mm or at most 11 mm or at most 10 mm or at most 8 mm.
  • a practitioner e.g. nurse or doctor
  • deflate and/or remove the balloon rather 'quickly' - e.g. within 60 seconds or 30 seconds or 15 seconds from a time that boundary is formed.
  • This may be useful for reducing a risk of suffocation to the patient.
  • the provisioning of a single mechanism for both pressurized fluid delivery as well as maintenance of boundary can be useful for reducing the risk that, at the end of the procedure whereby an inner surface 201 of tube 60 is cleaned, the practitioner remembers to 'shut off the fluid delivery but neglects to deflate boundary- forming balloon 588.
  • FIG. 17B illustrates an embodiment wherein a single fluids lumen 520 supplies both fluids delivery lumen 520 and an interior of balloon 588 with fluid (e.g. liquid and/or gas - for example, a pressurized fluid such as a pressurized liquid).
  • fluid e.g. liquid and/or gas - for example, a pressurized fluid such as a pressurized liquid.
  • the fluid travels within lumen 520 - at location 516, a first portion of the fluid that has travelled within lumen 520 continues in a distal direction into balloon 588 to inflate balloon 518; a second portion of the fluid that has travelled within lumen 520 exits into proximal portion 774 of the interstitial region via fluid delivery orifice 525.
  • the balloon as illustrated in FIGS. 17A-17B is sealed and is not leaky - this is in contrast to the balloon of FIG. 16A which is leaky and has voids/holes therein.
  • one or more of (i.e. any combination) the following features may be provided: (i) a single lumen 520 or a single fluids source 602 supplies fluid to fluid delivery orifice 525 and to inflatable balloon 588; and/or (ii) a single lumen 520 or a single fluids source 602 supplies fluid to fluid delivery orifice 525 and to an inflatable no n- leaky or sealed balloon 588; and/or (iii) a single lumen 520 or a single fluids source 602 supplies fluid to inflatable balloon 588 and to a fluid delivery orifice 525 not located on balloon 588 (e.g. proximal to balloon 588 - e.g. by at least 3 mm or at least 5 mm or at least 1 cm).
  • FIGS. 18-22 relate to an embodiment whereby cleaning device includes a 'mist- formation assembly.'
  • a mist is formed by combining (i) a gas or gas-rich fluid (e.g. from fluid source 602A) and (ii) a liquid or liquid-rich fluid (e.g. from fluids source 602B).
  • the gas or gas-rich fluid is received into a first fluid-delivery lumen 520A (e.g.
  • the liquid or liquid-rich fluid forms droplets which are suspended within the gas of or the gas-rich fluid, thereby forming the mist.
  • an elongate, flexible, main body 210 that is insertable through the tube- connector assembly 158 into the ventilation tube 60 to form an interstitial region outside of the main body 210 within ventilation tube 60;
  • a pliable sleeve 610 around at least a portion of the main body 210 in locations proximal to the tube-connector assembly 158 and distal to the suction port 830 to inhibit contamination.
  • a ballooned cleaning device for use with an ETT or tracheostomy ventilation tube 60, a ventilator machine 900, a source(s) of fluid and a source(s) of suctioning 603, the cleaning device comprising:
  • a ballooned cleaning device for use with an ETT or tracheostomy ventilation tube 60, a ventilator machine 900, a source(s) of fluid and a source(s) of suctioning 603, the cleaning device comprising:
  • suction lumen(s) 530 arranged within or along the main body, and operative to convey negative pressure from suction source(s) 603 via suction orifice(s) 440 when balloon 588 is inflated into contact, suction orifice(s) 440 being open to the proximal portion 774 and mechanically coupled to the main body 210.
  • the main body is insertable through the tube-connector assembly 158 into the ventilation tube 60 and/or the fluid delivery orifice is located on or mechanically coupled to the main body 210.
  • the balloon is fluid-inflatable, and the device is configured so that for a given fluid delivery lumen 520, a first portion of fluid flowing through the given fluid delivery lumen enters into the proximal portion 774 after passing through fluid delivery orifice(s) 525, and a second portion of fluid flowing through the given fluid delivery lumen inflates balloon 588.
  • balloon 588 is leaky and fluid delivery orifice(s) that is supplied by fluid via the given fluid delivery lumen 520 is located on a surface 589 of balloon 588. In some embodiments, the balloon 588 is sealed and fluid delivery orifice(s) that is supplied by fluid via the given fluid delivery lumen 520 is not located on a surface 589 of balloon 588. In some embodiments, fluid delivery orifice(s) that is supplied by fluid via the given fluid delivery lumen 520 is located proximal to balloon 588.
  • a cleaning device for use with an ETT or tracheostomy ventilation tube 60, a ventilator machine 900, a source(s) of fluid and a source(s) of suctioning 603, the cleaning device comprising:
  • a tube-connector assembly 158 for connecting the ventilation tube 60 to the ventilator machine 900, in a substantially air-tight manner
  • an elongate, flexible, main body 210 that is insertable through the tube- connector assembly 158 into the ventilation tube 60 to form an interstitial region outside of the main body 210 within ventilation tube 60;
  • a width-expandable wiping element 588 mounted to the main body 210 and width-expandable in a direction perpendicular to an elongate axis of the main body 210 into contact with an inner surface 201 of the ventilation tube 60;
  • a cleaning device for use with an ETT or tracheostomy ventilation tube 60, a ventilator machine 900, a source(s) of fluid and a source(s) of suctioning 603, the cleaning device comprising:
  • a cleaning device for use with an ETT or tracheostomy ventilation tube 60, a ventilator machine 900, a source(s) of fluid and a source(s) of suctioning 603, the cleaning device comprising:
  • a tube-connector assembly 158 for connecting the ventilation tube 60 to the ventilator machine 900, in a substantially air-tight manner; b. an elongate, flexible, main body 210 that is insertable through the tube- connector assembly 158 into the ventilation tube 60 to form an interstitial region outside of the main body 210 within ventilation tube 60;
  • first 220 and second 240 fluid delivery lumen(s) arranged within or along the elongated main body, and operative to transport fluid, received respectively from first and second fluid source(s) outside of the ventilation tube 60, into a proximal portion 774 of the interstitial region that is proximal of the wiping element 588 so that the:
  • fluid respectively transported through the first 220A and second 220B fluid delivery lumen(s) respectively enters the proximal portion 774 via first 224 and second 244 orifices that are separated from each other by at most 5 mm and that are each located on or mechanically coupled to the main body 210;
  • a suction port 830 connectable to the suction source(s) 603 for mediating a connection between the suction source and the suction lumen(s) ;
  • a tube-connector assembly 158 for connecting the ventilation tube 60 to the ventilator machine 900, in a substantially air-tight manner
  • an elongate, flexible, main body 210 that is insertable through the tube- connector assembly 158 into the ventilation tube 60 to form an interstitial region outside of the main body 210 within ventilation tube 60;
  • a width-expandable wiping element 588 mounted to the main body 210 and width-expandable in a direction perpendicular to an elongate axis of the main body 210 into contact with an inner surface 201 of the ventilation tube 60;
  • a mist formation assembly operative, when the main body 210 is inserted through the tube-connector assembly 158 into the ventilation tube 60, to form a mist from a liquid-containing fluid and a gas-containing fluid so that the formed mist flows within a proximal portion 774 of the interstitial region that is proximal of the wiping element 588
  • suction lumen(s) 530 arranged within or along the main body, and operative to convey negative pressure from suction source(s) 603 predominantly into the proximal portion 774 of interstitial region via suction orifice(s) 440 when wiping element 588 is expanded into contact, suction orifice(s) 440 being open to the proximal portion 774 and mechanically coupled to the main body 210;
  • a suction port 830 connectable to the suction source(s) 603 for mediating a connection between the suction source and the suction lumen(s) ;
  • a pliable sleeve 610 around at least a portion of the main body 210 in locations proximal to the tube-connector assembly 158 and distal to the suction port 830 to inhibit contamination.
  • the mist is formed within the main body 210. In some embodiments, when the main body is inserted through the tube-connector assembly 158 into the ventilation tube 60 to form the interstitial region, the mist is formed within the main body in location(s) within ventilation tube 60.
  • the mist formation assembly includes first and second fluid- delivery lumen(s) arranged within or along the elongated main body and respectively operative to receive and transport the liquid-containing and gas-containing fluids.
  • the mist formation assembly includes a common orifice via which material transported within the first and second fluid-delivery lumen(s) enters into the proximal portion 774 of the interstitial region.
  • the first and second fluid-delivery lumen(s) merge within main body 210 at a merge or mixing location 522.
  • the first 224 and second 244 orifices are separated from each other by at most 4 mm or at most 3 mm or at most 2 mm or at most 1 mm.
  • a width-expandable wiping element 588 mounted to the main body 210 and width-expandable in a direction perpendicular to an elongate axis of the main body 210;
  • a pliable sleeve 610 around at least a portion of the main body 210 in locations proximal to the tube-connector assembly 158 and distal to the suction port 830 to inhibit contamination.
  • the device and liquid source configured, when the main body 210 is inserted within the ventilation tube 60, such that the pressurized liquid received from the fluid(s) source or a derivative thereof enters proximal portion 774 after passing through fluid delivery orifice(s).
  • the device and liquid source configured, when the main body 210 is inserted within the ventilation tube 60, such that the fluid received from the fluid(s) source or a derivative thereof enters proximal portion 774 after passing through fluid delivery orifice(s).
  • the fluid(s) source includes a source of unpressuriazed fluid.
  • an elongate, flexible, main body 210 traverses an interior of the tube connector assembly 158 so that a distal end of the main body 210 is located within the ventilation tube 60 to form an interstitial region outside of the main body 210 and within the ventilator tube;
  • an inflatable balloon 588 mounted to the main body 210 is located within the ventilation tube 60;
  • a ventilation machine 900 is connected to the ventilation tube 60 via a tube connector assembly 158 in a substantially air-tight manner;
  • an elongate, flexible, main body 210 traverses an interior of the tube connector assembly 158 so that a distal end of the main body 210 is located within the ventilation tube 60 to form an interstitial region outside of the main body 210 and within the ventilator tube; iii. a width-expandable wiping element 588 mounted to the main body 210 is located within the ventilation tube 60;
  • sources of fluid 602 and suction 603 are and are respectively in fluid communication with fluid delivery orifice(s) 525 and suction orifice(s) 440, the suction 440 orifice(s) being located proximal to wiping element 588 within ventilation tube 60 and on main body 210 or mechanically coupled to main body 210,
  • suction 440 and fluid delivery 525 orifice(s) are in fluid
  • an elongate, flexible, main body 210 traverses an interior of the tube connector assembly 158 so that a distal end of the main body 210 is located within the ventilation tube 60 to form an interstitial region outside of the main body 210 and within the ventilator tube; iii. a width-expandable wiping element 588 mounted to the main body 210 is located within the ventilation tube 60;
  • the balloon is mounted to the main body 210 at a location in a distal half, or distal third, or distal quarter, or distal fifth or distal tenth of the main body 210.
  • the system lacks suction orifice(s) more distal than the balloon 558 and/or distal to boundary and in fluid communication with suction source 603.
  • the combined total aperture area of any and all suction orifices in fluid communication with suction source 603 and more distal than the balloon 588 and/or open to distal locations 778 is at most 50%, or at most 40%, or at most 30%, or at most 20%, or at most 10% of the combined total aperture area of any and all suction orifices 440 in fluid communication with suction source 603 and proximal to the balloon 558 and/or open to proximal location(s) 774.
  • the system is operative such that:
  • a second fluid delivery orifice 525B deployed substantially to a second side of the elongate main body 210 that is on opposite side of main body central axis 202 within a tolerance that is at most 75 degrees or at most 45 degrees or at most 25 degrees.
  • all suction lumen(s) are collectively not in fluid communication with any suction orifice located distal to balloon 588.
  • kits including one or more parts which, when assembled, form any presently disclosed apparatus or device or portion thereof are also in the scope of the invention.
  • connector assembly 158 and/or input module assembly 156 and/or any port disclosed herein may be provided as parts which may be assembled on-site (e.g. in the intensive care ward).
  • sleeve 610 may be part of a kit and deployed on site. Other configurations are within the scope of embodiments of the invention.

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  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Emergency Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Respiratory Apparatuses And Protective Means (AREA)
  • Endoscopes (AREA)
  • Cleaning In General (AREA)
PCT/IB2012/051532 2011-03-29 2012-03-29 Ballooned ventilation tube cleaning device Ceased WO2012131626A2 (en)

Priority Applications (20)

Application Number Priority Date Filing Date Title
EP19163574.7A EP3572112B1 (en) 2011-03-29 2012-03-29 Ballooned ventilation tube cleaning device
EP12719067.6A EP2714168B1 (en) 2011-03-29 2012-03-29 Ballooned ventilation tube cleaning device
AU2012235744A AU2012235744A1 (en) 2011-03-29 2012-03-29 Ballooned ventilation tube cleaning device
CN201290000559.9U CN204208149U (zh) 2011-03-29 2012-03-29 气囊式通气管清洗装置
JP2014501798A JP2014527412A (ja) 2011-03-29 2012-03-29 バルーン型換気チューブクリーニング装置
US14/008,558 US10322253B2 (en) 2011-03-29 2012-03-29 Ballooned ventilation tube cleaning device
EP12828334.8A EP2809382B1 (en) 2011-08-26 2012-08-26 Suction catheter with fluid input module for cleaning tracheal tubes
AU2012303609A AU2012303609A1 (en) 2011-08-26 2012-08-26 Fluid input module for multi-lumen catheters
PCT/IL2012/000320 WO2013030821A1 (en) 2011-08-26 2012-08-26 Fluid input module for multi-lumen catheters
BR112014004602-6A BR112014004602A2 (pt) 2011-08-26 2012-08-26 módulo de entrada de fluido para cateteres multi-lúmen
JP2014526598A JP6122435B2 (ja) 2011-08-26 2012-08-26 マルチルーメンカテーテル用流体入力モジュール
US13/806,958 US8999074B2 (en) 2011-03-29 2012-08-26 Fluid input module for multi-lumen catheters
US14/596,905 US20150133864A1 (en) 2011-03-29 2015-01-14 Suction catheter with distal suction modulation
US14/993,757 US10143814B2 (en) 2011-03-29 2016-01-12 Fluid input module for multi-lumen catheters
US15/069,150 US10328224B2 (en) 2011-03-29 2016-03-14 Mechanical user control of fluid input module
US15/377,575 US20170106160A1 (en) 2011-03-29 2016-12-13 Suction catheter with distal suction modulation
AU2017204274A AU2017204274A1 (en) 2011-08-26 2017-06-23 Fluid input module for multi-lumen catheters
US16/443,755 US10806884B2 (en) 2011-03-29 2019-06-17 Ballooned ventilation tube cleaning device
US16/450,936 US20190381266A1 (en) 2011-03-29 2019-06-24 Mechanical user control of fluid input module
US17/074,006 US20210128856A1 (en) 2011-03-29 2020-10-19 Ballooned ventilation tube cleaning device

Applications Claiming Priority (28)

Application Number Priority Date Filing Date Title
US201161468990P 2011-03-29 2011-03-29
US61/468,990 2011-03-29
US201161473790P 2011-04-10 2011-04-10
US61/473,790 2011-04-10
US201161483699P 2011-05-08 2011-05-08
US61/483,699 2011-05-08
US201161496019P 2011-06-12 2011-06-12
US61/496,019 2011-06-12
US201161527658P 2011-08-26 2011-08-26
US61/527,658 2011-08-26
PL396436A PL396436A1 (pl) 2011-09-26 2011-09-26 Balonowe urzadzenie do czyszczenia rurek intubacyjnych
PLPL396436 2011-09-26
US201161539998P 2011-09-28 2011-09-28
GB1116735.0 2011-09-28
GB1116735.0A GB2482618B (en) 2011-09-26 2011-09-28 Ballooned ventilation tube cleaning device
US61/539,998 2011-09-28
US201161560385P 2011-11-16 2011-11-16
US61/560,385 2011-11-16
GB1119794.4 2011-11-16
GBGB1119794.4A GB201119794D0 (en) 2011-11-16 2011-11-16 Ballooned ventilation tube cleaning device
US201261603340P 2012-02-26 2012-02-26
US201261603344P 2012-02-26 2012-02-26
US61/603,344 2012-02-26
US61/603,340 2012-02-26
US201261609763P 2012-03-12 2012-03-12
US61/609,763 2012-03-12
US201261613408P 2012-03-20 2012-03-20
US61/613,408 2012-03-20

Related Child Applications (4)

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US14/008,558 A-371-Of-International US10322253B2 (en) 2011-03-29 2012-03-29 Ballooned ventilation tube cleaning device
PCT/IL2012/000320 Continuation-In-Part WO2013030821A1 (en) 2011-03-29 2012-08-26 Fluid input module for multi-lumen catheters
US13/806,958 Continuation-In-Part US8999074B2 (en) 2011-03-29 2012-08-26 Fluid input module for multi-lumen catheters
US16/443,755 Continuation US10806884B2 (en) 2011-03-29 2019-06-17 Ballooned ventilation tube cleaning device

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WO2012131626A2 true WO2012131626A2 (en) 2012-10-04
WO2012131626A3 WO2012131626A3 (en) 2012-11-29

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US (3) US10322253B2 (cg-RX-API-DMAC7.html)
EP (2) EP3572112B1 (cg-RX-API-DMAC7.html)
JP (2) JP2014527412A (cg-RX-API-DMAC7.html)
CN (1) CN204208149U (cg-RX-API-DMAC7.html)
AU (1) AU2012235744A1 (cg-RX-API-DMAC7.html)
WO (1) WO2012131626A2 (cg-RX-API-DMAC7.html)

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US10322253B2 (en) 2019-06-18
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US20140246015A1 (en) 2014-09-04
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WO2012131626A3 (en) 2012-11-29
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