This specification relates to patient ventilators and ventilation systems. In particular, although not exclusively, this specification relates to multi-place BiPAP non-invasive patient ventilation systems for pre-critical care applications where patient breathing assistance is required. Further, it is a non-exclusive object of this specification to provide a patient ventilation system which may allow the adjustment and pre-setting of key treatment parameters that will allow use by a range of patients.
Ventilation systems may be used by a patient to assist breathing where the patient is experiencing respiratory difficulties.
One form of ventilation is non-invasive ventilation (NIV) which relies upon the patient wearing a face mask or similar that allows ventilation without invasive intubation and therefore can be administered to patients who are able to maintain an airway and some breathing function but who require assistance.
Such ventilation techniques use an increased positive pressure of breathing gas to assist patients during recovery from respiratory failure (RF).
The use of such ventilation is useful in supporting patients while the underlying cause or condition that has led to the RF is reversed. For patients who are heading into RF this technique can provide assistance and breathing support for a critical period, for example, while a patient's immune system deals with an underlying viral infection. Importantly, the use of NIV may prevent declining patient health that would normally result in the need for invasive ventilation.
There are a number of different techniques used in NIV therapy, some more complex than others. Two known techniques are CPAP and BiPAP.
The BiPAP technique refers to Bi-level Positive Airway Pressure where a different pressure is supplied to the patient during the inspiration and expiration phases of the breathing cycle. This technique is suited to the treatment of both Type I and Type II hypercapnic RF or a combination of both. For this reason, the use of BiPAP is generally considered as more effective and versatile than simple CPAP as it allows actual breathing assistance during a complete breathing cycle.
For conventional mechanical non-invasive clinical ventilators, BiPAP (or a derivative thereof) may be the preferred mode of operation/treatment, and the critical breathing parameters of pressure, flow and volume (over time) are adjustable by clinicians.
The design and manufacture of fully adjustable BiPAP ventilator systems is complex and involved, particularly where parameters are variable over a wide operating range and a wide range of patients. There are also issues with electrical power consumption and use of compressed oxygen gas supplies which may be considerable where a large number of ventilator systems are rapidly deployed.
There is, therefore, a need to provide a ventilation system which alleviates one or more problems associated with the prior art.
Accordingly, a first aspect is provided by a ventilator manifold as claimed in claim 1. Further aspects of the manifold are provided in dependent claims 2 to 18.
In accordance with a second aspect of the present invention, there is provided a ventilator system as claimed in claim 29. Further aspects of the system are provided by dependent claims 30 to 38.
Embodiments of the ventilation manifold and system are described, by way of example, with reference to the accompanying drawings, in which:
Referring firstly to
The breathing gas may be compressed and include, for example, air, oxygen or compressed oxygen and air supplied from a mixing manifold (not shown). The mixing manifold (not shown) may permit selection of breathing gas mixture with oxygen concentrations anywhere in the range of 21-100%. The manifold 13 presents the breathing gas for a ventilator action to the patient, for example inspiration, and for exhaust of spent gas from the patient, for example exhalation, in a breathing process. As will be appreciated, the breathing gas will have a range of composition from that substantially of nascent air about the patient to higher levels of oxygen dependent upon patient requirements.
The ventilator 1 and/or ventilator manifold 13 may be formed using additive manufacturing, moulding and/or a combination of additive and subtractive methods. It will be appreciated that the material from which the manifold is formed must be acceptable for hygiene purposes and typically must be capable of being rendered sterile in a clinical environment. The ventilator 1 and/or ventilator manifold 13 may be disposable.
Now referring to
A number of manifolds 13 may be provided (small, medium, large and the like) specifically or notionally related to patient lung capacity or patient requirements with each manifold located or otherwise assembled with the mask or ventilator as required.
During an inspiration stage (breath in), the breathing gas passes to the patient from the source of breathing gas. The breathing gas may enter a first chamber 41 via fluid conduit 14 at a pressure above ambient. The breathing gas may then follow a source path 43 via a constriction path 42, before entering a second chamber 411. The breathing gas may then exit the second chamber 411 and flow towards the mask 12. The breathing gas is drawn into the mask 12 via its positive pressure. The breathing gas flow rate may be continuous. It will be appreciated that the size and/or configuration of the chambers and paths above may be adapted to adjust the flow rate of the breathing gas. This may be advantageous to provide different breathing gas flow rates for different patients.
In an exhalation stage, the pressure of the breathing gas within the constriction path 42 directs the expelled spent breath gas to a vent path 44 and through a vent exhaust 45. The breathing gas following the constriction path 42 may also be directed to the vent path 44.
Thus, in the inspiration stage, the breathing gas is presented to the user as a slight over-pressure to facilitate ventilator action in the patient's lungs dependent upon the constriction path 42, whilst upon exhalation due to a patient's muscle and diaphragm contraction, the spent gas exhalation is directed to the vent path against the slight gas pressure through the constriction path 42.
Accordingly, in normal operation the manifold 13 and associated ventilator system will work based upon simple patient breathing action. Thus, the inhalation stage will use the patient breathing action to cause breathing gas flow to the patient and the exhalation will act against the breathing gas pressure so that this pressure acts as a ‘switch’ to urge expelled spent gas from the patient to the exhaust vent 45.
The ventilator manifold 13 is a non-mechanical device with no moving parts. The ventilator manifold 13 attaches to a breathing circuit which is in turn connected to a breathing mask 12 worn by the patient. This provides a fluid logic ventilator. A fluid logic ventilator may rely on passing a fluid (for example, breathable gas) through a Y-shaped cavity with control orifices which toggle flow automatically between the two branches of the Y-shaped cavity in a cyclic manner. The ventilator 1 may be a pressure cycled assistor-controller ventilator consisting of a single bi-stable load switched non-moving part fluid logic element.
This simple design permits a range of manufacturing methods to be employed in the construction of the ventilator, including but not limited to machining, moulding, 3D printing and fabrication. The design is such that the system can either be configured as an assembly comprising a series of individual components, or can be manufactured as a single piece component using advanced manufacturing methods such as, but not limited to selective laser sintering, stereolithographic, fusion deposition and metal additive manufacturing methods. Such a design could optionally include an integrated fluidic logic block and top plate, and may also include integrated inlet and exhaust ports, control port connectors, and the facility to incorporate a filtration device, and/or pressure relief valve, on any or all of the inlet, inhalation, and exhaust ports.
The fluid logic ventilator in a fixed form is not generally adjustable but allows the adjustment and pre-setting of key treatment parameters allowing use by a range of patients. Normally an open path is dependent upon the configuration of an inlet breathing gas chamber, the configuration (size, width, length, straight/curved/undulating and the like) of the constriction path 42, source path 43 to the ventilator mask 12, vent path 44, and also the relative angles between these elements. The angles are relative to a manifold 13 axis typically determined by the constriction path 42 with a source angle to one side of the axis and a vent angle to the other. In a conventional ventilator manifold these angles, configurations, and orientations are fixed. A set of ventilator manifolds may be provided which are fixed for different configurations so each ventilator manifold 13 is inter-changeable in the mask 12 for different results as required for specific current patient requirements and breathing gas conditions. Different sized manifolds 13 and/or different configurations of the above parameters may be provided to control the flow of breathable gas through the ventilator 1.
Further, a peak inspiratory pressure (PIP) and hence the tidal volume (VT) varies proportionally with the ventilator supply pressure allowing convenient control of the above key parameters. The end expiratory pressure is set to atmosphere, or by a PEEP valve connected downstream of the exhaust 45, the effort required to initiate a switch from inspiration to expiration is a function of the geometry of the ventilator manifold 13 and supply pressure, it changes based on supply pressure, with higher supply pressures requiring increased effort to initiate a switch. In some cases, the expiratory pressure may be pre-set by the geometry of the fluid logic element 2 defined by the ventilator manifold 13 and remains constant if fixed over typical supply pressure ranges. Further, it is possible to modify this by employing the aforementioned variable restriction feedback loops, if present. A range of minute volumes can be delivered through the use of different ventilator devices with the same geometry but with different cavity aspect ratios in the respective inter-changeable ventilator manifolds 13 in a set provided for the ventilator 1.
An alternative to providing a set of ventilator manifolds 13 is for the angles, orientations and dimensions to be adjustable in their own right but with clear constructional complications. Nevertheless, with some designs, rather than have ventilator manifold adjustment in a ventilator by using different fixed manifold sizes, a more generic manifold may be used with a length, width and eccentricity of the constriction path, source path to the ventilator, and vent path adjusted as required. Such adjustment may be by simple expansion and contraction upon adjusters as well rotation of the angles as required upon appropriate assemblies, then fixed in the desired configuration for a desired ventilator manifold and ventilator operation. Such adjusters may be conventional slip, ratchet or screw adjusters (for example, a grub screw) but also may be provided by presenting the element (source path, vent path and/or constriction path) in shape memory material which may then be fixed by curing or other means in use.
It will also be understood that constructional features such as ledges, ribs and grooves which themselves may be adjustable into and out of the flow paths can be provided as required for adjustment from a generic manifold or to allow fine adjustments by medical staff for individual current patient requirements. It will be appreciated that such adjustments may be conducted with gloved-hands. As such, grub screw type mechanisms may be preferred.
Now referring to
For single patient applications in a clinical situation the breathing gas provided to the ventilator 1 can simply be a hospital ring-main or cylinder-based gas supply (air, oxygen or a mixture) reduced to a pressure between 15 cmH2O (1.47 kPa) and 400 cmH2O (39.22 kPa) for inspiratory pressures between 5 cmH2O (0.49 kPa) and 40 cmH2O (3.92 kPa).
This may be advantageous for pre-clinical patient treatment in a non-hospital setting, for example: repurposed hotels, community centres or schools. In such environments there is the opportunity to deliver ventilator gas supplies to multiple ventilators (and patients) simultaneously from simple air compressors augmented by oxygen supply cylinders local to the patient, if elevated FiO2 patient treatment is indicated.
The ventilator air delivery system may comprise an air compressor to generate the increased air supply pressure, a filtration system to assure air quality and local gas storage to ensure delivery continuity. A preferred scenario is to be able to use air compressors of a variety of types, manufacturers and specifications such that existing equipment (or available equipment) can be used.
Further, this delivery system would be typically located remotely from patients to avoid issues of equipment noise and operator attendance for maintenance and operational duties.
Fluids, including breathing gas for example, may be delivered to each patient's location through a system of low-pressure fluid delivery hoses where a supply pressure would be maintained at a suitable level to feed separate local pressure regulators (and oxygen mixing manifolds) local to each patient.
Optional gas humidification may be provided at the patient's location to improve tolerance to the ventilator and patient comfort, as can a gas exhaust system that will remove high oxygen concentration exhaust gases to an outdoor vent location.
Systems may be sized to meet an expected typical treatment centre, so capacity for between 8 and 20 patients from one system may be provided, for example—or more, if required. Multiple systems may be deployed where greater numbers are needed. Of course, these are examples of numbers and capacity may be scaled to meet requirements.
On an exhalation stage shown in
As will be appreciated, relative configuration, orientation and angles will determinate flow operation using the logic switch of the breathing gas pressure in the constriction path 42. Further control can be provided by regulator or control elements 46, 47 associated with the constriction path 42. One or more regulator element(s) 46, 47 may be included, in particular, two regulator elements may be included. Further regulator elements 46, 47 may be included as required.
The regulator or control elements 46, 47 are typically a path with a void at the end away from the constriction. The voids provide controlling features in terms of the breathing process and also provide sizing so that couplings to means for pressure regulation in the element 46, 47 can be provided. This pressure regulation may be with compressed air into the elements or induction of reduced pressure to stimulate flow and so assist the breathing process.
The regulator elements 46, 47 as indicated previously are normally fixed but could be adjustable in terms of length, orientation, as well as being switchable into or out of action with an operable valve, and having variable restrictions linked to either atmosphere, or a feedback loop. The regulator elements 46, 47 may be configured in a variety of ways to influence the operating parameters of the ventilator, and may act to exert a force on the inlet flow through the constriction path 42, applied via means of pressure, flow, or acoustic resonance, to influence the direction of the inlet (source) flow as it exits the constriction path 42, and direct it towards either the source path 43 or vent path 44.
Further, the regulator elements 46,47 may direct fluid flow exiting the constriction path 42 and/or source path 43. The regulator elements 46, 47 may be fluidly connected to a pressurised source. A differential pressure in a regulator element 46, 47 may provide means for directing a flow following the constriction path 42 and/or source path 43. Application of a differential pressure to either regulator element 46, 47 may provide switching of a flow path within the ventilator manifold 13. Switching frequency may be synchronised to a desired patient's requirements.
As shown in
Further optionally, control or regulator paths and voids may be provided in the manifold 13. These paths and voids may be actively switched into operation by applying gas pressure or a reduced pressure in timed sequence and/or in response to pressure sensors to stimulate or initiate gas flows in the inhalation stage and exhalation stage. These control or regulator paths will add some complication but will provide some ‘power-assistance’ to some patients whose breathing action is mildly compromised ensuring adequate breathing gas enters the lungs. It will also be understood that normally as can be seen in the graph shown in
It will be appreciated that the breathing process is one of push and pull with the breathing gas pressure being the push into the lungs with patient muscular action, and the push provided by contraction of the lungs as well as configuration of the manifold for venting of the expelled spent gas from the lungs.
It will be further appreciated that any regulator element 46, 47 may amplify a pressure and/or flow rate as required. As such, the ventilator 1 is bi-stable when oscillating and/or amplifying.
The ventilator 1 may optionally include variably controlled feedback systems on either of, or both of, the inhalation 14 and/or exhalation branches 11 providing feedback to either of, or both of the regulator elements 46, 47 to permit the flow characteristic of the circuit to be modified.
While the invention has been illustrated and described in detail in the drawings and preceding description, such illustration and description are to be considered illustrative or exemplary and non-limiting.
Other variations of the invention can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. Each feature of the invention may be replaced by alternative features serving the same, equivalent or similar purpose, unless stated otherwise. Therefore, unless stated otherwise, each feature disclosed is one example of a generic series of equivalent or similar features.
In the claims, the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality.
Any reference signs in the claims should not be construed as limiting the scope.
Number | Date | Country | Kind |
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2004281.8 | Mar 2020 | GB | national |
Filing Document | Filing Date | Country | Kind |
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PCT/IB2021/052448 | 3/24/2021 | WO |