VENTILATION

The present invention relates generally to docking port designs for a combined anaesthesia and portable ventilator system.

Background

International Application No. PCT/GB2021/052280 (the contents of which are incorporated by reference) describes a portable ventilator module that reversibly connects to an anaesthesia module via a docking port to enable the provision of volatile anaesthesia. The present application provides a docking mechanism suitable for linking two such modules.

Description

An aspect of the present invention provides a method of providing a functional connection between an independent portable patient ventilator module and an anaesthesia module designed to facilitate the recirculation of exhaust gases, addition of oxygen and/or air and/or nitrous oxide and the provision of volatile anaesthetic agents including or not including the scavenging of exhaust gases for volatile anaesthesia whereby a docking port is provided in both ventilator and anaesthesia modules that houses gas inlet/outlet connections and electrical connections for the transfer or power and/or performance data and/or display data and/or hospital network data and/or connections that demonstrate intact positioning of the ventilator module with respect to the anaesthesia module.

A further aspect provides a method of providing a gas-tight connection between a portable ventilator module and a corresponding anaesthesia module whereby the anaesthesia module contains inlet and outlet gas connectors with a captured o-ring that is compressed by an angled face on the reciprocal connector in the ventilator module to produce a gas tight seal.

Also provided is a method of allowing movement to align and adequately compress components described in claim 2 whereby the gas manifold of the anaesthesia module is mounted on springs to provide limited lateral movement and a set force to compress the o-ring seal between the anaesthesia and ventilator module gas connection components.

A further aspect provides a docking mechanism to provide a functional connection between an independent portable patient ventilator module and an anaesthesia module.

A docking port may be provided in both ventilator and anaesthesia modules that houses gas in let/outlet connections and electrical connections for the transfer or power and/or performance data and/or display data and/or hospital network data and/or connections that demonstrate intact positioning of the ventilator module with respect to the anaesthesia module. An anaesthesia module may contain inlet and outlet gas connectors with a captured o-ring that is compressed by an angled face on the reciprocal connector in the ventilator module to produce a gas tight seal.

The mechanism may be capable of allowing movement to align and adequately compress components, whereby a gas manifold of the anaesthesia module is mounted on springs to provide limited lateral movement and a set force to compress the o-ring seal between the anaesthesia and ventilator module gas connection components.

A further aspect provides a portable ventilator module that reversibly connects to an anaesthesia module via a docking port to enable the provision of volatile anaesthesia and includes a docking mechanism suitable for linking two such modules.

A further aspect provides a docking system for a portable ventilator module that reversibly connects to an anaesthesia module via a docking port to enable the provision of volatile anaesthesia, including a docking mechanism suitable for linking two such modules.

A further aspect provides a modular anaesthesia machine with a detachable, portable and independent ventilator module containing patient breathing tube connections and a separate, dependent anaesthesia module wherein when separate, the ventilator module is capable of life support ventilation and wherein the ventilator module can dock with the anaesthesia module to provide additional features for the provision of volatile anaesthesia and recirculation of exhaled gases.

In order to dock, separate gas inlet and outlet ports are required to complete a circle patient circuit.

In one embodiment of the invention, the ventilator module has replaceable docking connectors. These docking connectors provide a sealing face corresponding to the sealing face of the receiving docking connectors on the anaesthesia module. Each docking port also has a seal to the ventilator module with securing screws to ensure connection to the docking module.

The docking system may be required to pass one or more of power, communication, display, ethernet and positioning data between the modules.

In a further embodiment of the invention, the docking port area contains electrical connections for the transfer of power from the anaesthesia module to the portable ventilator module to provide energy to deliver ventilation functions and/or to charge the internal batteries.

In a further embodiment of the invention, the docking port area contains electrical connections for the transfer of information between the anaesthesia and ventilator modules. In an embodiment of the invention, this transfer of information is by CANBus. In a further embodiment of the invention, electrical connections for the transmission of display data and touchscreen command for a secondary display are transferred from the ventilator module, through a docking port electrical connection to a secondary display on the anaesthesia module.

In a further embodiment of the invention, electrical connections for the transfer of information from connection to the hospital network (e.g. ethernet) is made across the docking port.

In a further embodiment of the invention, the docking port contains electrical connections to confirm the correct positioning of the ventilator and anaesthesia modules in the docking process. The confirmation that docking position is within limits is required before changes are made that allow gas recirculation and passage through the docking connections and modules. It is envisaged that other methods can be used to detect the correct positioning of the portable ventilator module during docking with the anaesthesia module, for example proximity sensors using acoustic, infra-red or magnetic detection methods.

In an embodiment of the invention, the docking port electrical connections are provided with a seal that prevents oxygen from a leaking gas connection entering the electrical docking connection and potentially leading to a risk of fire.

In one embodiment of the invention, the provision of power to the docking port connections from either the ventilator or anaesthesia module is only delivered when the contacts that confirm correct position are complete, to reduce the risk of oxygen leak over electrical connections or electrical shock to the user.

The docking port gas connection must be gas-tight as anaesthesia circuits often run in a low-flow state where only small volumes of gas are added to the circuit each minute (approximately 200ml/min). The circuit may operate in a pressurised state (up to 150cmH2O pressure) and the seals must be able to cope with these pressures and potential negative pressures due to patient deep inhalation with low circuit volume.

In an embodiment of the invention, the gas connection from the ventilator module has a face at an angle at or over 45 degrees that compresses against a captured o-ring seal internally in the anaesthesia connector, although other angles other than 45 degrees (e.g. less than 45 degrees) are envisaged. The angle of the seal must mean that the face seal can be disengaged without drawing the o-ring from the anaesthesia module gas connection.

In an embodiment, the anaesthesia module gas connection is shaped so that the ventilator module gas connection angled face contacts the anaesthesia gas module connector when the correct placement and thus o-ring compression is achieved to ensure a gas-tight seal.

In an embodiment, successful docking takes place in two steps. In the first step (primary docking), the user must be able to place the portable ventilator module to link to and be held by the static anaesthesia module with the ventilator module supported and safe in its location. As a second step ("Docking Completion”), the user pushes the ventilator module along a guided motion pathway that positions the ventilator module gas connection into the anaesthesia module gas connection and provides the necessary force to compress the o-ring in the anaesthesia module to create a gas-tight seal.

In another embodiment of the invention, Docking Completion can be provided mechanically either by the use of pneumatics or electrically driven motors to power the movement of the portable ventilator module into the fully docked position.

In one embodiment of the invention, the anaesthesia module has an inflatable seal for each of the gas inlet and outlet of the anaethesia module. When the ventilator module is in the Docking Completion position, the inflatable seals are pressurised and extend from the anaesthesia module to press against a corresponding face on the ventilator module to create a gas-tight seal. When undocking is selected, the pressure is removed and the seal returns to its prepressurised form within the anaesthesia module. This process may be supplemented by the use of vacuum.

The use of an o-ring to seal each gas pathway may be combined with the inflatable seal by using the inflatable seal around the o-ring connection components described in this application for each gas pathway to prevent the leakage of patient gases into the operating room and/or devices. In an embodiment of the invention, an electromagnet is used to secure the ventilator module to the anaesthesia module following or as part of docking completion. In the case of failure of one of the modules, safety systems will remove the load from the electromagnet and the ventilator and anaesthesia modules will disconnect from completed docking, but still be safely secured from falling by the primary docking. This will ensure that life-preserving ventilation will be maintained in the case of system failure of the anaesthesia module.

In an embodiment of the invention, if a safe state is triggered by failure or one or both of the ventilation or anaesthesia modules, the docking is released so that the portable ventilator module still remains safely in place but so that it can be removed by the user (i.e. any locking system is disengaged).

In order to maintain an appropriate gas seal, force is required to compress the o-ring in the anaesthesia module. In an embodiment of the invention, the force is provided by the user during guided movement in docking completion. In an embodiment, the force is controlled by the anaesthesia manifold of the anaesthesia module being mounted on springs with a controlled spring force required to ensure adequate sealing of the gas connection. The springs in the anaesthesia module are able to move laterally to ensure that the correct docking position is found and provide a controlled force to ensure adequate compression of the o-ring seal but not too much compression to lead to damage to either the ventilator or anaesthesia module docking components. In another embodiment of the invention, a rotary compression mechanism is located on the anaesthesia module. The user places the portable ventilation module onto the anaesthesia module, first engaging the rounded front of the ventilator module into a corresponding moulding on the front of the anaesthesia module, forming a hinge. The rear of the portable ventilator module has connecting points with roller bearings on either side, which engage inside a cam in the anaesthesia module. At this stage, the base of the portable ventilator module and anaesthesia module are held apart by the location of the bearings within the cam. When Docking Completion is triggered by touch command on the ventilator module by the user, a servomotor rotates the cam leading to the ventilator module being drawn down to the anaesthesia module, rotating at the hinge formed between the ventilator and anaesthesia modules. As the gas components from each module come together, the o-ring seal is compressed to ensure a gas-tight connection. The cam locks the modules together. It is envisaged that an alternative method of powering the rotary connection could be used by someone skilled in the art, for example stepper motor or pneumatic rotary actuator. The cam may be operated so that in a power-off state, the cam rotates to the open position and releases the ventilator module. This may be by use of a spring or pneumatic actuator although other methods are familiar to those skilled in the art.

The docking port gas and electrical connections should be covered when the docking port is not in use to prevent dust and contaminants entering the docking area and also to reduce the risk of electrical shock to the user. In an embodiment, these covers that protect the gas/electrical connections retract as part of the primary docking process. In an embodiment of the invention, this is driven mechanically by gears/levers inside the ventilator and anaesthesia module that are connected to pins on both sides of the ventilator module that run though the guide rails on the anaesthesia module. The movement of the pins down the guide rail track pushes on levers/cams that drive the doors in both modules to the open positions. Springs return the doors to the closed position when the ventilator module is disengaged from the anaesthesia module.

In another embodiment, the doors are opened electromechanically after primary docking is complete as docking completion is triggered from the touchscreen display. Servomotors or pneumatics are used to drive open the doors ready for docking completion to proceed. They are returned to their closed position after the user triggers the release of docking via the touchscreen display.

The user is able to trigger undocking from the display during ventilation. The user must confirm the command after it is made, to ensure that an accidental undocking is not performed. In the case of desired and confirmed undocking, gas flow into the anaesthesia module is ceased and the anaesthesia gas circuit is disconnected from the ventilator module circuit by the use of valves in the ventilator module and/or anaesthesia module. The docking completion step is reversed to release the ventilator module from the anaesthesia module, power and communications are disconnected, the gas connection is disconnected and the doors are closed as the ventilator module is removed from the anaesthesia module. In a further embodiment of the invention, the docking port on the portable ventilator module can dock with a base station without gas connections, just using the electrical connections already mentioned to transfer power, display, data and ethernet from the base unit to the portable ventilator module. This enables the ventilator module to be mechanically connected to the base unit for stability and therefore connect to one or more of a secondary display, hospital data connection and power that are attached to the base unit. This base unit would be available in recovery, imaging or intensive care units where anaesthesia or anaesthesia gas scavenging may not be required.

In a further embodiment of the invention, the secondary display could be located at a distance from the base unit or in a nearby or adjacent room. This would be advantageous in the case of imaging where the patient and ventilator module must be in the imaging room that may be exposed to ionizing radiation or high strength magnetic fields and the user may be safely located in an adjacent room. In this case, functionality may be provided where the ventilator module may be controlled by the secondary touchscreen display. In an embodiment, the level of control is determined by a settings screen on the ventilator module so that only the desired functionality can be controlled by the secondary display.

In a further embodiment, gas inlet and outlet connections of the base unit may be present and connect to the ventilator module in the same way as the anaesthesia module gas connections connect to the ventilator module, with a gas-tight connection. The gas outlet connection is connected to a scavenging system (either passive or active as familiar to those skilled in the art). This connection is used to transport exhaust gases away from the area of use. This may be important in locations of long-term use such as Intensive Care Units and/or infectious cases where the passage of exhaust gases to ambient air in the area of use may carry with it risk of infection to the user(s) and/or postoperative recovery where volatile anaesthetic agents are still being exhaled by the patient and must be extracted for the safety of clinical personnel.

Different aspects and embodiments of the invention may be used separately or together.

Further particular and preferred aspects of the present invention are set out in the accompanying independent and dependent claims. Features of the dependent claims may be combined with the features of the independent claims as appropriate, and in combination other than those explicitly set out in the claims. Each aspect can be carried out independently of the other aspects or in combination with one or more of the other aspects.

The present invention will now be more particularly described, by way of example, with reference to the accompanying drawings.

The example embodiments are described in sufficient detail to enable those of ordinary skill in the art to embody and implement the systems and processes herein described. It is important to understand that embodiments can be provided in many alternative forms and should not be construed as limited to the examples set forth herein.

Accordingly, while embodiments can be modified in various ways and take on various alternative forms, specific embodiments thereof are shown in the drawings and described in detail below as examples. There is no intent to limit to the particular forms disclosed. On the contrary, all modifications, equivalents, and alternatives falling within the scope of the appended claims should be included. Elements of the example embodiments are consistently denoted by the same reference numerals throughout the drawings and detailed description where appropriate.

Unless otherwise defined, all terms (including technical and scientific terms) used herein are to be interpreted as is customary in the art. It will be further understood that terms in common usage should also be interpreted as is customary in the relevant art and not in an idealised or overly formal sense unless expressly so defined herein.

In the following description, all orientational terms, such as upper, lower, radially and axially, are used in relation to the drawings and should not be interpreted as limiting on the invention.

The terminology used herein to describe embodiments is not intended to limit the scope. The articles “a,” “an,” and “the” are singular in that they have a single referent, however the use of the singular form in the present document should not preclude the presence of more than one referent. In other words, elements referred to in the singular can number one or more, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises,” “comprising,” “includes,” and/or “including,” when used herein, specify the presence of stated features, items, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, items, steps, operations, elements, components, and/or groups thereof.

Detailed Description of Drawings

Figure 1A shows the portable ventilator module (1 ) being positioned by the user into the docking area of the anaesthesia module (2) where it remains in an undocked state, where the docking faces of the ventilator module and anaesthesia module are not yet come together (3), and where the ventilator module can be removed by the user but is also held to prevent the risk of the ventilator module falling when not held by the user.

Figure 1 B shows the portable ventilator module in the docked position, whereby the docking mechanism has pulled the docking faces of the ventilator and anaesthesia modules together (4) to facilitate the generation of a gas-tight seal between the ventilator module gas inlet and outlet and the anaethesia module outlet and inlet. Figure 2 shows a mechanical representation of the docking system for description. The docking port of the ventilator module (21 ) has a curved protrusion on the front face (23). This corresponds with a socket (24) on the anaesthesia module (22) docking port to create a hinge. Tabs on the ventilator module (26) with runners engage with a cam in the anaesthesia module (25) to prevent the ventilator module from falling from the anaesthesia docking station after initial positioning by the user. When the user selects to complete docking on the ventilator module graphical user interface (not shown) the cam in the anaesthesia module (25) rotates to bring the ventilator module docking port into contact with the anaesthesia docking port to facilitate the gas connection (not shown). When the user selects to undock the ventilator module, the cam (25) rotates in the alternate direction and the ventilator module docking port (21 ) is lifted away from the anaesthesia module docking port (22) and is ready to be removed by the user.

Figure 3 shows the sprung gas connection in the anaesthesia module. The gas connection (31 ) is mounted onto a plate (32). The plate is secured to the anaesthesia module body by a screw (joint shown 35). The screw is designed with a cylindrical section to support a spring in the groove shown (34- spring not shown). This spring supports the plate (32) against the anaesthesia module body. When the ventilator module gas connection (not shown) presses against the anaesthesia module gas connection (31 ), the spring provides minor lateral movement to allow adjustment to lateral alignment and vertical movement to accept the ventilator module gas connection and provides a constant force to ensure a gas tight connection. Figure 4 shows the gas connection between the ventilator and anaesthesia modules. The ventilator module (45) supports a plate (42) which is connected to the ventilator module gas connection (41 ). When the docking port is fully engaged and the ventilator module (45) has been brought into contact with the anaesthesia module (46) the ventilator gas connection (41) engages with the captured seal (44) in the anaethesia module gas connection (43) in the anaesthesia module (46). This provides a gas tight connection between the modules. The force between the gas connections, acting to compress the seal is controlled by the sprung anaesthesia connector as shown and described in figure 3.

Figure 5 shows the covers in the anaesthesia and ventilator modules. The ventilator module (52) cover is a sliding cover (53) that retracts to expose the ventilator module gas connection (51 ). The anaesthesia module (56) sliding cover (55) retracts from a fixed portion of the cover (54) to expose the anaesthesia gas connection (57). The anaesthesia module cover fits into a recess in the ventilator module (58) when the docking ports are brought together. All of the covers spring return to the closed position and are opened by actuator levers in the anaesthesia module that engage with slots in the covers (not shown).

Figure 6 shows the signal connections between the ventilator and anaesthesia modules (power connections not shown). Additional connections may be present that are not shown in this diagram. This diagram shows that the secondary display on the anaesthesia module is controlled by the ventilator module when the ventilator module is docked. The anaesthesia process controller “Anaesthesia” is connected to the ventilator controller “Ventilator” through the docking port. Serial and Ethernet connections pass through the anaesthesia module from the ventilator module from connections in the docking interface to mirror the connections present on the side of the ventilator module itself.

Although illustrative embodiments of the invention have been disclosed in detail herein, with reference to the accompanying drawings, it is understood that the invention is not limited to the precise embodiments shown and that various changes and modifications can be effected therein by one skilled in the art without departing from the scope of the invention as defined by the appended claims and their equivalents.