None.
This invention relates to a device for use in the critical care ventilation of patients.
It is necessary that mechanically ventilated patients have heat and moisture supplied/provided to their breathing gas otherwise complications will occur. Initial methods of humidification were based on a device for heating or bubbling water in order to create a vapour in the breathing stream which was referred to as active humidification. Active humidification has been in use for over 60 years and is considered to be very effective for patients in that it supplies copious amounts of moisture and is claimed to match the physiological humidification of the human body in that it can reach temperatures of 37° C. and deliver 44 mg H2O/l of moisture. Intensive testing has shown that popular known active humidification devices do not reach the claimed levels of 44 mg H2O/l at 37° C. at the patient. Because of its perceived capability of delivering 44 mg H2O/l at 37° C. active humidification is the preferred method used by many physicians but is also believed to be a necessity for certain indications such as when patients are on long term sedation, for paediatric patients or where the patient has poor oxygen uptake or tenacious secretions. Active humidification has the drawback of requiring bulky vapour generating equipment which is mounted on the ventilator with additional tubing and heated breathing tubes in order to prevent moisture build-up and pooling.
Passive humidification was effectively introduced some 30 years ago and involves a plastic enclosure which contains special filter material designed to capture and reflect the heat and moisture from the patient. The passive heat and moisture exchanger (HME) is placed in the breathing circuit between the Y-piece and the endotracheal tube (ET-tube) where it captures the heat and moisture from the patients' exhaled breath and releases it to the patient on inspiration.
The HME has the advantage of compactness with no additional equipment required. HME's operate at about 70 to 80% efficiency and typically return about 33 mg H2O/l to the patient which creates uncertainty for the use in certain conditions. For example, most schools of thought believe that HME's are not suitable for patients undergoing long term sedation and for use with paediatrics or patients with other certain indications. Despite some drawbacks HME's have become widely used particularly for adults and short intravenous sedations.
It is an object of the invention which is the subject of this patent application to address the aforementioned drawbacks of active and passive humidification. The combining of passive humidification with meaningful active humidification poses many challenges. There have been numerous attempts previously to solve these challenges, but all have only had limited success. There is therefore a need for an improved active and passive humidification device for mounting in patient ventilation circuits.
The present invention also relates to a sedation device for insertion between the ET-tube and the Y-piece of a ventilator circuit to vaporize and reflect/conserve a volatile sedative. This type of sedation device essentially comprises a housing having an interior separated by an activated carbon filter into a ventilator chamber and a patient chamber. The ventilator chamber connects to a ventilator and the patient chamber connects to the patient. An evaporator mounted in the patient chamber is operable to deliver a volatile sedative to the patient during breathing. Each time the patient exhales sedative, heat and moisture from the breathing gas is captured by the filter for subsequent release back into the airstream during the next inspiration. Thus, in addition to reflecting volatile sedative, the filter forms a passive humidifier which maintains a level of humidity in air inhaled by the patient. The capture and return of heat and moisture to the patient reduces the chance of adverse conditions associated with artificial ventilation occurring, such as the drying out of lung tissue or patient secretions, as well as considerably reducing the amount of respiratory heat lost by the body. The passive humidification provided by the sedation device can maintain an air temperature of about 33° C. and relative humidity of about 79%. However, the ideal amount of humidification for mechanically ventilated patients is an air temperature of 37° C. with 44 mg H2O/L absolute humidity resulting in 100% relative humidity.
The present invention is directed towards addressing the limitations of existing active and passive offerings which attempt to address these issues.
WO 2018/035579 A1 discloses a respiratory pressure therapy device for generating a flow of breathable air for delivery through a humidifier and an associated vaporizer to humidify the breathable air prior to delivery to a patient. The device may optionally include a heat and moisture exchange module downstream of the vaporizer, that is on the patient side of the vaporizer.
According to the invention, there is provided an active and passive humidification device for mounting in a patient ventilation circuit, the device, including: a housing having a ventilator chamber and an associated patient chamber communicating with the ventilator chamber through a gas permeable filter mounted between the ventilator chamber and the patient chamber; said filter forming a passive humidifier which is operable to capture and reflect heat and moisture received from a patient back to said patient; the ventilator chamber having a ventilator connection port for connection to a ventilator; the patient chamber having a patient connector port for connection to a patient breathing tube; an humidity generating device mounted on the housing and being operable to discharge moisture into the patient chamber; and characterized in that a heater is mounted within the patient chamber, a temperature sensor is mounted within the patient chamber, the humidity generating device, the heater and the temperature sensor being connected to an associated controller which is operable to regulate operation of the heater and the humidity generating device to maintain air at a desired temperature and humidity for delivery from the patient chamber to a patient.
Advantageously the active humidifier device operates in tandem with the passive humidification facilitated by the filter to maintain air at a desired optimum humidification for delivery to a patient.
In one embodiment of the invention, an air flow sensor is mounted within the housing to detect movement of air through the housing, the air flow sensor being connected to the controller which regulates operation of the humidity generating device such that the humidity generating device is switched on by the controller during a patient inhalation and switched off by the controller during a patient exhalation.
In another embodiment of the invention, the controller is operable to switch off the humidity generating device at a preset time interval before the end of a patient inhalation.
In another embodiment of the invention, the heater comprises a heater plate mounted within the patient chamber.
In another embodiment of the invention, the heater plate is shaped to correspond to the contour of an outer wall of the patient chamber.
In another embodiment of the invention, the heater plate is mounted against the outer wall of the patient chamber.
In another embodiment of the invention, the heater plate is mounted spaced-apart from the outer wall of the patient chamber.
In another embodiment of the invention, the heater plate has outwardly projecting fins on an inner face of the heater plate.
In another embodiment of the invention, the heater is a ceramic heater plate.
In another embodiment of the invention, an insulation element is mounted on the patient chamber outside the heater plate.
In another embodiment of the invention, the insulation element is mounted on an outside face of the outer wall of the patient chamber.
In another embodiment of the invention, the insulation element has a wiring conduit passing through the insulation element.
In another embodiment of the invention, the patient chamber has a bottom wall which slopes downwardly towards the patient connector port for delivery of any moisture collected in the patient chamber towards the patient connector port.
In another embodiment of the invention, a cowl is mounted about the air flow sensor, the cowl having an opening facing an outer end of the ventilator connector port.
In another embodiment of the invention, the air flow sensor is operable to detect the direction of air flow through the housing.
In another embodiment of the invention, the air flow sensor is operable to detect the volume of air flow through the housing.
In another embodiment of the invention, the air flow sensor is mounted within the ventilator connection port or the ventilator chamber.
In another embodiment of the invention, an evaporator is mounted within the patient chamber for delivery of a volatile anaesthetic into the patient chamber.
In another embodiment of the invention, the humidity generating device is demountably engageable with the housing.
In another embodiment of the invention, the humidity generating device is integral with the housing.
In another embodiment of the invention, the humidity generating device is mounted within the patient chamber.
In another embodiment of the invention, the humidity generating device is mounted at or adjacent the patient connector port.
In another embodiment, a humidifier mounting chamber is formed in the housing adjacent the patient connector port and the humidity generating device is housed within the humidifier mounting chamber, a passageway connects between the humidifier chamber and the patient connector port within which the humidity generating device is mounted.
In another embodiment, the temperature sensor is positioned at an exit from the patient chamber and is located downstream of the humidity generating device, between the humidity generating device and an outlet of the patient connector port.
The invention will be more clearly understood by the following description of some embodiments thereof, given by way of example only, with reference to the accompanying drawings.
Referring to the drawings, and initially to
The ventilator chamber 3 has a ventilator connector port 9 for connection to a ventilator 11. The patient chamber 4 has a patient connector port 10 for connection to a patient breathing tube 13. An evaporator, in this case provided by a vaporising rod 12, is mounted within the patient chamber 4. A humidity generating device 15 is integrated in the housing 2 and is operable to control the humidity of air delivered from the patient chamber 4 through the patient connector port 10 to a patient 8.
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A humidifier mounting chamber 24 is formed in the housing 2 adjacent the patient connector port 10. The humidity generating device 15 is housed within the humidifier mounting chamber 24. A passageway 25 connects between the humidifier chamber 24 and the patient connector port 10 within which the humidity generating device 15 is mounted. A gas sampling port 27 projects outwardly of the patient connector port 10 and can be connected to a gas sampling device 28 for measuring the anaesthetic content delivered to the patient 8.
The humidifier device 15 comprises a housing 30 mounted in the passageway 25 and having a vapour outlet 32 at a bottom of the housing 30. A water inlet 34 at a top of the housing 30 allows delivery of water or saline into the housing 30 for vaporisation and subsequent discharge of water vapour or saline vapour through the vapour outlet 32 into the patient connector port 10. A water or saline supply can be provided either by way of a refillable reservoir on the sedation device 1, or more preferably by a water feed line 35 from a remote water supply or reservoir 36 as shown in
The humidity generating device 15 is connected to an associated controller 37 which regulates operation of the humidity generating device 15. An associated air flow sensor 38 is mounted at the ventilator connector port 9 and is also connected to the controller 37. A temperature sensor 39 is mounted at the patient connector port 10 and connected to the controller 37. The temperature sensor 39 is positioned at an exit from the patient chamber 4 and is located downstream of the humidity generating device 15, that is between the humidity generating device 15 and an outlet 14 of the patient connector port 10 which connects to the patient 8 to ensure an accurate reading of the temperature of the humidified air delivered to the patient 8 upon inhalation.
The patient chamber 4 is fitted with a specially designed ceramic heater plate 40 which conforms and fits snugly to an inner face of the curved bottom wall 23 of the patient chamber 4. The heater plate 40 is shaped to correspond to the internal contour of the bottom wall 23, nesting against the bottom wall 23. The heater plate 40 is connected to the controller 37 and cooperates with the sensors 38, 39 and the humidity generating device 15. The heater plate 40 has a relatively large surface area to facilitate rapid and even temperature control within the patient chamber 4. The patient chamber 4 may be made from a heat-resistant, but biocompatible material.
An external surface of the patient chamber 4 is fitted with an insulation element 42 to protect the patient, medical professionals and the environment from the heat generated within the patient chamber 4 by the ceramic heater plate 40. The insulation element 42 is suitably shaped to match the contour of an exterior surface of the patient chamber 4 and to support ergonomic handling of the device 1. Conveniently, the insulation element 42 may facilitate the connection of the sensors 38, 39 and humidity generating device 15 to the controller 37 (or may have a Bluetooth sensor) and will incorporate all the wiring 33 connecting the heater plate 40, humidity generating device 15 and the sensors 38, 39 to the controller 37.
By controlling operation of the heater plate 40 and the humidity generating device 15, a range of temperatures and moisture outputs of 33° C. and 35.5 mg H2O/l up to 37° C. and 44 mg H2O/l can be achieved.
The airflow sensor 38 mounted in the ventilator chamber 3 will detect the beginning and end of inspiration and the controller 37 will stop the delivery of moisture at a predetermined point before the end of inspiration. This prevents the patient exhaling excess moisture onto the filter 5.
The air flow sensor 38 is operable to sense the direction of air flow through the device 1. It also measures the volume of air moving through the device 1 upon each inhalation and exhalation by the patient 8. The air flow sensor 38 will cooperate with the controller 37 to determine the flow rate and the duration of flow and will use its learned history to instruct the humidity generating device 15 to deliver the correct amount of moisture to achieve the required relative humidity at the preset temperature.
Referring in particular to
In use, the device 1 is mounted in the usual way in a ventilating system 50 between a ventilator 11 and a patient 8. A volatile sedative at a selected dosage is delivered into the air within the patient chamber 4 by the evaporator 12 for inhalation by the patient 8. As the patient 8 exhales, the exhaled air passes through the sedation device 1 and sedative, heat and moisture is captured by the filter 5 for subsequent release back into the air upon the next inhalation by the patient 8. Thus, the filter 5 provides a passive humidification of the air breathed by the patient 8. In this way the sedation device will operate at an air temperature of about 33° C. with 28 mg H2O/L absolute humidity resulting in 79% relative humidity. In addition to this passive humidification by operation of the humidity generating device 15 an optimum air condition, providing an air temperature of 37° C. with 44 mg H2O/L absolute humidity resulting in 100% relative humidity, can be achieved and maintained.
The controller 37 controls operation of the humidity generating device 15 and the heater plate 40. The air flow sensor 38 senses whether air is travelling to or from the ventilator 11. The controller 37 regulates operation of the humidity generating device 15 such that it is switched on by the controller 37 during a patient inhalation and switched off by the controller 37 during a patient exhalation. It will be noted that the controller 37 switches off the active humidity generating device 15 at a pre-set time interval before the end of a patient inhalation. The heater plate 40 is operable to control the temperature of air delivered to the patient 8. The temperature sensor 39 senses air temperature at the patient connector port 10 and the controller 37 controls operation of the heater plate 40 to achieve the desired air temperature. Further, in response to the sensed temperature, the controller 37 operates the humidity generating device 15 to achieve a desired relative humidity in the air delivered to the patient 8. Typically, this will be at or approaching 100% relative humidity and may be controlled within a desired range of 85%-100% relative humidity at a controlled constant temperature ranging up to 37° C. More preferably the humidity is controlled to between 95%-100% relative humidity and most preferably at about 95% relative humidity which advantageously avoids rainout and possible excess moisture build-up.
The controller 37 uses the inputs from the air flow sensor 38 and the temperature sensor 39 to regulate operation of the heater plate 40 and the humidity generating device 15 to maintain air delivered to the patient 8 at a desired temperature and humidity.
Advantageously the device 1 of the invention is relatively compact and can be readily easily inserted into a breathing tube 13 which communicates between a ventilator 11 and a patient 8.
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It will be appreciated that any suitable humidity generating device may be employed in the devices of the invention, including for example a perforated piezoelectric plate, an ultrasonic vibrating plate, a syringe vaporizer for squeezing water through a perforated plate, an injection or infusion device or a heated wick.
It will further be appreciated that the heater plates provided in the devices of the invention may be of any suitable material and construction.
The device and method of the present invention provides a number of advantages over existing active and passive humidification devices, including:
The terms “comprise” and “include”, and any variations thereof required for grammatical reasons, are to be considered as interchangeable and accorded the widest possible interpretation.
The invention is not limited to the embodiments hereinbefore described but may be varied in construction and detail within the scope of the appended claims.
Number | Date | Country | Kind |
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19177739.0 | May 2019 | EP | regional |
This application is a national phase to PCT Application No. PCT/EP2020/065077 filed May 29, 2020 which in turn claims priority to European Patent Application No. 19177739.0 filed May 31, 2019, wherein all said applications incorporated in their entirety herein by reference thereto.
Filing Document | Filing Date | Country | Kind |
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PCT/EP2020/065077 | 5/29/2020 | WO | 00 |