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
  • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
  • A61M16/0808—Condensation traps
• • 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
  • A61M16/0875—Connecting 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. ventilators; Tracheal tubes
  • A61M16/10—Preparation of respiratory gases or vapours
  • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
  • A61M16/16—Devices to humidify the respiration air
• • 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
• • 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
• • 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
• • 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
  • A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes

Definitions

• the present invention relates generally to a medical device. More particularly, the present invention is related to a moisture removal and condensation and humidity management apparatus for placement with a breathing circuit.
• a breathing circuit delivers medical gas to a patient under pressure in a prescribed volume and breathing rate.
• the medical gas is often humidified by a humidifier located at or near the ventilator or respirator.
• the optimum respiratory circuit delivers 100% RH medical gases to the patient while reducing the amount of humidity and subsequent condensate delivered back to the ventilator through the expiratory limb. Therefore, the humidified gas has to travel through all or most of the tubing and has time to cool. Cooling of the gas leads to rainout or condensation in the breathing tube and collection of water within the breathing circuit.
• a heating wire provided along the length of the tube.
• the wire may be provided within the interior of the tubing or alternatively may be embedded along the interior of the tubing.
• the wire heats the humidified gas traveling through the tubing to prevent the gas from cooling, thus preventing the problem of water condensing out of the gas traveling through the breathing circuit.
• the manufacture of such heated wire respiratory circuits can be time consuming and costly.
• a water collection apparatus is typically placed in the expiratory limb of the respiratory circuit to collect and allow for manual removal of excessive condensation prior to the gases entering the ventilator or respirator. It is known that excessive condensate entering a ventilator or respirator from the expiratory limb of a respiratory circuit can harm the device.
• the water collection device is designed to trap the condensed water vapor in a removable container.
• a valve can be actuated to create a gas tight seal for the breathing circuit.
• this type of water collection device has to be monitored and manually emptied, causing risk of patient or caregiver infection.
• the removal of moisture and condensation management is not automatic.
• the removable container is often only at one discrete point along the breathing circuit, and may need to be lowered to gravitationally collect liquid, which may be impractical.
• Another possible solution is to provide a permeable membrane in the breathing circuit tubing which is permeable to water vapor but impermeable to liquid water, such that moisture inside the breathing gas flow inside such tubing dissipates to outside the tubing via such a membrane, and out to the ambient air surrounding the tubing.
• the problem with this solution is at least two-fold: first, such a thin walled membrane which is exposed to the
• the improved apparatus for removing or decreasing water vapor, moisture, or condensate in a breathing circuit eliminates the need to monitor the device or to heat the exhalation limb of the breathing tube, and is not dependent on the positioning of the device, protects the device and its moisture and humidity transmission mechanism from damage, and increases its capacity for moisture removal and condensation management in a breathing circuit.
• a moisture removal and condensation and humidity management apparatus for a breathing circuit arranged between a patient and a ventilator, comprising a breathing circuit tubing defining a breathing gas conduit for a flow of breathing gas therein, the breathing gas having a first humidity level and a level of moisture or condensate therein.
• a dry gas conduit is disposed adjacent at least a portion of the breathing gas conduit for a dry gas flow in said dry gas conduit, the dry gas flow being configured to have a second humidity level lower than the first humidity level.
• a moisture transmission pathway is included between the breathing gas conduit and the dry gas conduit, such that humidity in the flow of breathing gas is lowered and moisture or condensate in the flow of breathing gas is transferred to the dry gas flow.
• the dry gas conduit is closed to ambient air around the apparatus
• the breathing circuit tubing comprises a permeable portion which is permeable to water vapor but impermeable to liquid water, such that the moisture transmission pathway is provided by such permeable portion of the breathing circuit tubing.
• the breathing circuit tubing is formed by an inner tube defining the breathing gas conduit
• the dry gas conduit is formed by an outer tube surrounding the inner tube, the dry gas conduit being defined by an annular flow conduit defined between the inner tube and outer tube.
• the breathing circuit tubing is formed by an inner tube defining the breathing gas conduit
• the dry gas conduit is formed by an outer tube surrounding the inner tube, an annular space being defined between the inner tube and outer tube.
• a dividing wall is formed between the inner tube and outer tube in the annular space to divide the dry gas conduit into a first, delivery conduit for flow of dry gas from a first end of the apparatus to a second end of the apparatus, and a second, return conduit for flow of dry gas from the second end of the apparatus to the first end of the apparatus.
• the permeable portion of the breathing circuit tubing is a permeable membrane which forms a portion of said breathing circuit tubing.
• the breathing circuit tubing comprises one or more perforations which permit drainage of liquid water from the breathing gas conduit to the dry gas conduit, such that the moisture transmission pathway is provided by such one or more perforations of the breathing circuit tubing.
• the breathing circuit conduit and dry gas conduit share a common dividing wall, the common dividing wall having the moisture transmission pathway.
• the common dividing wall comprises a permeable portion which is permeable to water vapor but impermeable to liquid water, such that the moisture transmission pathway is provided by such permeable portion of the common dividing wall.
• the permeable portion of the breathing circuit tubing is a permeable membrane which forms a portion of said common dividing wall.
• the common dividing wall comprises one or more perforations which permit drainage of liquid water from the breathing gas conduit to the dry gas conduit, such that the moisture transmission pathway is provided by such one or more perforations of the common dividing wall.
• an exit port is provided on the apparatus for the dry gas conduit having a filter, the dry gas exiting via the exit port to the ambient environment surrounding the apparatus.
• an input port is provided on the apparatus for the dry gas conduit having a flow or volumetric control element for the dry gas flow.
• an exit port is provided on the apparatus for the dry gas conduit which is connected to a source of suction.
• method of removing moisture or controlling condensation in a breathing circuit comprising providing an apparatus as disclosed in any of the preceding recited embodiments of the present invention.
• the apparatus is configured and arranged to be disposed between a ventilator and a patient.
• Breathing gas is supplied via the breathing circuit tubing to a patient.
• dry air is supplied through the dry gas conduit to remove moisture or liquid water condensate from the breathing gas conduit.
• one or more of the first and second humidity levels may be monitored using a humidity sensor.
• the breathing circuit tubing is an expiratory limb of a ventilator circuit.
• FIG. 1 is a schematic view illustrating an apparatus incorporated into or as part of a breathing gas circuit in accordance with one or more embodiments of the present invention
• FIG. 2 a schematic cross-sectional view illustrating the apparatus of FIG. 1 in one or more embodiments of the present invention
• FIG. 3 a schematic cross-sectional view illustrating the apparatus of FIG. 1 in one or more additional embodiments of the present invention
• FIG. 4 is a schematic cross sectional view of an apparatus incorporated into or as part of a breathing gas circuit in accordance with one or more additional embodiments of the present invention.
• a moisture removal and condensation and humidity management apparatus for a breathing circuit to rapidly remove water vapor or condensate from a humidified medical gas traveling through a breathing circuit between a ventilator and a patient or the patient and the ventilator.
• a “breathing circuit” or “breathing gas circuit” is any arrangement of tubing or conduits which carries gases to be administered to and from a patient, such as from a ventilator, and which may include additional accessories or devices attached to it.
• Such “breathing gases” may include oxygen, air or any component thereof, and are configured for absorbing high levels of moisture and/or being humidified prior to administration to a patient, or during
• FIG. 1 is a schematic view illustrating an apparatus incorporated into or as part of a breathing gas circuit in accordance with one or more embodiments of the present invention.
• a moisture removal and condensation and humidity management apparatus 10 for a breathing circuit includes a section or length of breathing circuit tubing 1 1 defining a breathing gas conduit 12 for a flow (B) of breathing gas therein.
• the breathing gas flows from a first, upstream end 10A of the device 10, through the conduit 12 defined within device 10, to a second, downstream end 10B of the device 10.
• the breathing gas is configured to have a first humidity level and a level of moisture therein, which may be calibrated based on the needs of the patient.
• such a length of breathing circuit tubing 1 1 may be in an expiratory limb of a breathing circuit, such as, for example, somewhere between a patient and a ventilator.
• a dry gas conduit 14 is defined adjacent at least a portion of the breathing gas conduit 12 between the first end 10A and second end 10B, for a dry gas flow (D) therein.
• the dry gas flow (D) is configured to have a second humidity level which is lower than the first humidity level within the breathing gas conduit (B).
• a dry gas flow is coupled from a dry gas source (not shown) to one or more input ports 40 which feed the dry gas flow (D) into the dry gas conduit 14, which then flows substantially parallel to, or around the breathing gas conduit 12.
• FIG. 2 a schematic cross-sectional view illustrating the apparatus of FIG. 1 in one or more embodiments of the present invention.
• the dry gas conduit 14 may be an annular flow space which is concentric with breathing gas conduit 12.
• the breathing circuit tubing 1 1 may be formed by an inner tube 20 defining the breathing gas conduit 12, and the dry gas conduit 14 is formed by an outer sleeve or tube 22 surrounding the inner tube 20, the dry gas conduit 14 thereby being defined as an annular flow conduit 24 defined between the inner tube 20 and outer tube 22.
• One, or both, of the inner and outer conduits may be formed by corrugated tubing.
• the inner tube 20 could define the dry gas conduit 14 and the annular space 24 between the inner and outer tubes 20, 22 could be the breathing gas conduit 12.
• a sufficient stretch of surface area is shared along the breathing circuit tubing 1 1 between the breathing gas conduit 12 and dry gas conduit 14 such that a moisture and humidity transmission pathway is enabled between the two conduits, as further described below.
• the present invention provides one or more embodiments which provide a moisture transmission pathway between the breathing gas conduit 12 and the dry gas conduit 14, such that humidity in the flow of breathing gas (B) is lowered and moisture in the flow of breathing gas (B) is transferred to the dry gas flow (D).
• a moisture transmission pathway (T) occurs between the higher humidity breathing gases in conduit 12 and the lower humidity dry gas flow in conduit 14.
• a user can increase or decrease the level of dry gas supplied to the circuit to manage or remove the condensate which may be transmitted from the breathing gas (B) to the dry gas conduit. The moisture level thus may be reduced from within the breathing gas flow and transferred to the dry gas flow.
• FIG. 1 such as shown in FIG.
• the breathing circuit tubing 1 1 comprises a permeable portion (not shown) along part or all of the inner conduit 20 is provided, which is permeable to water vapor but impermeable to liquid water, such that the moisture transmission pathway (T) is provided by such permeable portion of the breathing circuit tubing.
• the materials comprising the permeable portion are water vapor breathable and allow passage of water vapor, as is well known to those of ordinary skill in the art.
• the permeable portion may form some or all of the walls of the breathing gas conduit 12, such as inner tube 20, and may include a single, or composite outer, layer of water vapor breathable medium. In one embodiment, an additional wicking layer may be added to the permeable portion. In the embodiment shown in FIG.
• the additional wicking layer may be disposed as an inner layer of inner conduit 20, configured to be in contact with breathing gas flow (B) inside said conduit.
• a wicking layer may be made of wicking material which allows for adsorption and/or absorption of both moisture and water in any phase, gas or liquid, using a capillary action, while the outer layer of water vapor breathable medium permits the passage of water vapor only and not liquid water.
• wicking material in the inner layer are a knit or non- woven cloth or fabric, and can be synthetic and made of polyester, polyester and polypropylene blends, nylon, polyethylene or paper, and can be
• microfilaments or microfiber material such as Evolon® brand fabric material made by Freudenberg & Co. KG.
• a particular example of wicking material would be a non-woven material of 70% polypropylene and 30% polyester.
• Another example of the wicking material can be Evolon® brand fabric material having a weight of 60 or 80 grams per square meter.
• Examples of the outer layer of water vapor breathable medium are Sympatex® brand water vapor permeable membranes made of polymers made by Sympatex Technologies, including monolithic hydrophilic polyester ester membrane, including, as one example, a 12 micron thick membrane.
• the breathing circuit tubing 1 1 comprises one or more small openings or perforations (not shown) in inner tube 20 which permit drainage of liquid water from the breathing gas conduit 12 to the dry gas conduit 14, such that another, different, moisture transmission pathway T1 is provided by such one or more perforations between the breathing gas flow (B) and dry gas flow (D), such as shown in FIG. 2.
• FIG. 3 a schematic cross-sectional view illustrating the apparatus of FIG. 1 in one or more additional embodiments of the present invention.
• a dividing wall 30 is formed between the inner tube 20 and outer tube 22 in the annular space between said tubes to divide the dry gas conduit into a first, delivery conduit 32 for flow of dry gas (D1 ) from a first end of the apparatus 10 to a second end of the apparatus, and a second, return conduit 34 for flow of dry gas (D2) from the second end of the apparatus to the first end of the apparatus 10.
• the dry gas flow may be re-used, such as, for example, in a closed loop system.
• One or more moisture transmission pathways may be defined between breathing gas flow conduit (B) and one or both of dry gas conduits (D1 , D2), including a permeable membrane
• the permeable membrane is permeable to water vapor but impermeable to liquid water and may include one or more layers, including a wicking layer, as described above.
• FIG. 4 is a schematic cross sectional view of an apparatus 100 incorporated into or as part of a breathing gas circuit in accordance with one or more additional embodiments of the present invention.
• a breathing circuit tubing 101 defines a breathing gas conduit 1 12 for a flow of breathing gas flow (B) therein, said breathing gas having a first humidity level and a level of moisture therein, and a dry gas conduit 1 14 is formed adjacent at least a portion of the breathing gas conduitl 12 for a dry gas flow (D) therein, said dry gas flow configured to have a second humidity level lower than the first humidity level.
• B breathing gas flow
• D dry gas flow
• a moisture transmission pathway (T2) is provided between the breathing gas conduit 1 12 and the dry gas conduit 1 14, such that humidity in the flow of breathing gas (B) is lowered and moisture in the flow of breathing gas (B) is transferred to the dry gas flow (D).
• the breathing gas conduit 1 12 and dry gas conduit 1 14 share a common dividing wall 130, the common dividing wall 130 having the moisture transmission pathway (T2), which may be provided by a permeable membrane incorporated into part or all of the dividing wall 130, as described herein, or a series of perforations in part or all of the dividing wall 130, as also described herein.
• the permeable membrane is permeable to water vapor but impermeable to liquid water and may include one or more layers, including a wicking layer, as described above.
• the dry gas conduit 14, 32, 34, 1 14 can be closed to ambient air around the apparatus.
• the dry gas conduit therefore can be configured to provide a stream of dry gas flow at humidity levels which are significantly lower than the humidity in the breathing gas conduit 12, 1 12.
• An exit port for the dry gas conduit may further include a filter, the dry gas exiting via the exit port to the ambient environment surrounding the apparatus. Such an exit port may also be connected to a source of suction.
• An input port for the dry gas conduit may include a flow or volumetric control element for the dry gas flow.
• the present invention therefore uses the differential between humidity or moisture content between the respective flows in the breathing gas conduit 12, 1 12, vs. the dry gas conduit 14, 32, 34, 1 14, which allows for greater extraction or diffusion of moisture and humidity from the breathing gas flow to the dry gas flow, which is further assisted by the convective action of the dry gas flow along the common surface area shared between the breathing gas conduit 12, 1 12, and the dry gas conduit 14, 32, 34, 1 14, such as along inner conduit 20, or common dividing wall 130.
• the present invention therefore provides a superior way of removal of moisture or water vapor from a breathing circuit, which is better than water traps or other fluid dissipation or moisture removal devices known in the prior art.
• the result of the inventive apparatus disclosed is that when the apparatus is coupled with a breathing circuit, rainout or condensation in the breathing tube and collection of water within the breathing circuit is significantly reduced.
• the present invention therefore allows for removal of the collected condensate on the inner walls of a breathing gas conduit, which is then transported away through an outer sleeve which provides the dry gas conduit.
• the outer tube of the apparatus can also serve to protect the inner tube from damage or puncture, which can be especially vulnerable to damage or puncture when it incorporates a permeable membrane and/or perforations as described herein.
• an additional outer cover structure can be added to the apparatus.
• the present invention therefore represents an improvement over the known prior art by providing the benefits of: (a) reducing or eliminating user management of condensate levels within a breathing circuit, and/or (b) reducing the humidity output from an expiratory limb of a breathing circuit to reduce the collection of condensate which may be collected in the ventilator.

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• Health & Medical Sciences (AREA)
• Emergency Medicine (AREA)
• Pulmonology (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Separation Using Semi-Permeable Membranes (AREA)
• Respiratory Apparatuses And Protective Means (AREA)

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Citations (5)

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• 2016
  • 2016-04-14 US US15/099,051 patent/US11471636B2/en active Active
  • 2016-04-15 WO PCT/US2016/027682 patent/WO2016168548A1/en not_active Ceased
  • 2016-04-15 CA CA2982676A patent/CA2982676C/en active Active
  • 2016-04-15 EP EP22209171.2A patent/EP4159261B1/en active Active
  • 2016-04-15 AU AU2016250271A patent/AU2016250271B2/en active Active
  • 2016-04-15 EP EP16780803.9A patent/EP3283153B1/en active Active
  • 2016-04-15 JP JP2017554281A patent/JP7382699B2/ja active Active
• 2022
  • 2022-10-14 US US17/966,613 patent/US20230030671A1/en active Pending
• 2023
  • 2023-05-16 JP JP2023080545A patent/JP2023100991A/ja active Pending
• 2025
  • 2025-06-17 JP JP2025100969A patent/JP2025124928A/ja active Pending

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