IMPROVEMENTS IN OR RELATING TO PATIENT CARE

Abstract

A portable ventilator module is provided and includes a data module capable of artificial intelligence (AI) and/or machine learning (ML). The ventilator module is detachably attachable to an anaesthesia module to enable a single device to collect data from a patient in critical care and theatre environments. Also provided is a system for the unbroken acquisition of data from the entire patient stay in critical care, emergency areas and theatres in a single device by including a data module capable of AI or ML within a portable ventilator module, wherein the portable ventilator module can provide life-sustaining ventilation support to a patient in critical care and wherein the portable ventilator can dock with an anaesthesia module to provide anaesthesia during operations in theatre so that a machine change from an ICU ventilator to a separate anaesthesia machine and back again is not required, thereby avoiding data loss.

Claims

1-35. (canceled)

36. A portable ventilator module comprising a data module capable of artificial intelligence (AI), machine learning (ML), or a combination thereof; wherein the portable ventilator module is detachably attachable to an anaesthesia module to enable a single device to collect data from a patient in critical care and theatre environments.

37. The portable ventilator module of claim 36, wherein: the data module comprises an Artificial Intelligence (AI) module for the acquisition of data from a patient stay on ventilation; wherein the AI module is capable of performing analysis of the data; wherein the AI module can be inserted into or form part of the portable ventilator to provide life-sustaining ventilation support to the patient in critical care; and wherein the portable ventilator can dock with the anaesthesia module to provide anaesthesia during operations in theatre.

38. The portable ventilator module of claim 37, wherein: the AI module is configured for unbroken acquisition of data from a patient stay in critical care, emergency areas, and theatres; and a machine change from an ICU ventilator to a separate anaesthesia machine and back again is not required, thereby avoiding data loss.

39. A modular anaesthesia machine comprising: a detachable, portable, and independent ventilator module, the ventilator module comprising patient breathing tube connections; a separate, independent 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.

40. The modular anaesthesia machine of claim 39, wherein when the anaesthesia module is not connected, air is drawn in from atmosphere by the action of a ventilator module turbine.

41. The modular anaesthesia machine of claim 39, wherein ambient air is mixed with oxygen for ventilation when the ventilation module is not connected and wherein pressurised air is mixed with pressurised oxygen when the anaesthesia module is connected.

42. The modular anaesthesia machine of claim 39, wherein the ventilation module is a master module and includes a ventilation processor, wherein the anaesthesia module has its own processor.

43. The modular anaesthesia machine of claim 39, comprising an anaesthesia module controller that interfaces with components in the anaesthesia module and communicates with the ventilator module.

44. The modular anaesthesia machine of claim 39, further comprising a display for the anaesthesia module, the display independent of the ventilation module and active when the anaesthesia module is powered on but not necessarily connected to the ventilation module, the display configured to display parameters specific to the anaesthesia module.

45. The modular anaesthesia machine of claim 39, wherein the anaesthesia module can be powered on and tested when connected to a first ventilation module and subsequently disconnected from the first ventilation module and connected to a second ventilation module for a following patient.

46. The modular anaesthesia machine of claim 39, wherein the anaesthesia module can be powered on and tested when connected to a first ventilation module and remain connected to the first ventilation module until powered off.

47. The modular anaesthesia machine of claim 39, wherein the ventilation module comprises a docking port capable of providing an interface for a secondary display, wherein the docking port can also be used to connect to the anaesthesia module.

48. The modular anaesthesia machine of claim 39, wherein the ventilation module comprises a docking port capable of connecting the ventilator module to the anaesthesia module via a single location.

49. The modular anaesthesia machine of claim 48, wherein the docking port comprises a connection capable of connecting recirculated gas from the anaesthesia module to an air intake input in the ventilator module.

50. The modular anaesthesia machine of claim 48, wherein the docking port comprises a connection capable of connecting exhaled gas from the patient from the ventilator module with a recirculation intake of the anaesthesia module.

51. The modular anaesthesia machine of claim 48, wherein the docking port comprises a communication connection capable of connecting a controller for the ventilator module with a controller for the anaesthesia module.

52. The modular anaesthesia machine of claim 48, wherein the docking port comprises a connection capable of passing power from the anaesthesia module to the ventilator module.

53. The modular anaesthesia machine of claim 48, wherein the docking port comprises an Ethernet connection capable of linking an Ethernet output form the ventilation module to a healthcare institution Local Area Network.

54. The modular anaesthesia machine of claim 39, wherein: the ventilator module comprises contacts capable of confirming correct placement of the ventilator module when docking with the anaesthesia module; or the anaesthesia module comprises contacts capable of confirming correct placement of the ventilator module when docking with the anaesthesia module.

55. A system, comprising: a portable ventilator module comprising an Artificial Intelligence (AI) module capable of AI, machine learning (ML), or a combination thereof; wherein the portable ventilator module is detachably attachable to an anaesthesia module to enable a single device to collect data from a patient in critical care and theatre environments; wherein the AI module is capable of acquisition of data from a patient stay on ventilation; wherein the AI module is capable of performing analysis of the data; wherein the AI module can be inserted into or form part of the portable ventilator to provide life-sustaining ventilation support to the patient in critical care; wherein the portable ventilator can dock with the anaesthesia module to provide anaesthesia during operations in theatre; and wherein the ventilator module comprises a connection to the internet or a hospital intranet thereby allowing a user to request help from other experienced clinicians; wherein the ventilator module may transmit data comprising audio and/or visual information to a compatible device used by an experienced remote user; wherein the compatible device comprises a similar ventilator module; wherein transmission of data comprising audio and/or visual information from the similar ventilator module to the ventilator module is capable of aiding the user.

Description

DETAILED DESCRIPTION OF DRAWINGS

[0143] FIG. 1—Piping and Instrumentation Diagram

KEY

[0144] V—ventilator [0145] A—anaesthesia [0146] 11—Medical oxygen [0147] 22—Medical air [0148] 33—Mixed medical air/oxygen [0149] 44—Expired air/oxygen mixture [0150] 55—Medical N2O [0151] 66—Ambient air [0152] Functional unit [0153] Feedback loop

[0154] A separate anaesthesia module detaches from ventilator module.

[0155] When the ventilator module is operating independently. Pressurised oxygen from tank 11-CY1 passes through a filter 11-F2 and one way valve 11-CV2 to a pressure reducing valve 11-PRV1, reducing the pressure to 3 bar. The pressure in the oxygen cylinder 11-CY1 is monitored by 11-PT2. The pressure downstream of 11-PRV1 is monitored by 11-PT1. 11-PT1 also detects the pipeline oxygen pressure from ISO-standard connectors 11-C1. Pipeline oxygen passes through the filter 11-F1 and one way valve 11-CV1 to prevent reverse flow. Pipeline oxygen is supplied at 4-6 bar and therefore, oxygen supplies from 11-C2 should only be used if the pipeline pressure drops below 3 bar. 11-PRV2 reduces the pressure to 2.6 bar, monitored by 11-PT3. The flow of oxygen into the patient circuit is controlled by 11-PFV1 with measurement from 11-FM1. When in ventilator-only mode, oxygen is mixed with ambient air drawn from the air inlet 44-C3 and monitored by oxygen sensor 33-02T1 and temperature sensor 33-TT1. Air and oxygen are drawn into the dynamically controlled turbine 33-T1, which pressurises the air and oxygen to drive inspiration and maintains an appropriate speed to prevent back-flow of gas during the remainder of the respiratory cycle. The inspiratory pressure is monitored by 33-PT1 and the flow monitored by 33-FT1 with outlet temperature monitored by 33-TT2. Inspiratory gases pass through the ISO standard connector 33-C1 into the disposable patient circuit tubing external to the machine. A near-patient flowmeter 44-FT1 and pressure transducer 44-PT1 are connected between the y-piece and the patient connection (e.g. Endotracheal tube). The near patient devices are connected to the device for power (3.3-5 v) and communication (e.g. UART). Inspiratory and expiratory gases pass to and from the patient via a Heat and Moisture Exchange (HME) filter 44-F1. Pressure relief can be placed in the inspiratory or expiratory limbs or near-patient as shown. Expiratory gases return to the device via the standard ISO connector 44-C1 with flow monitoring by 44-FT2. A water trap 44-VVT1 removes any liquid water from the circuit. The pressure of the patient circuit is controlled by a Positive End Expiratory Pressure (PEEP) valve 44-PEEPV1. The PEEP valve control can be but is not limited to a diaphragm-type with gas pressure from the oxygen supply regulated by inlet and outlet proportional valves under the control of a pressure transducer and microcontroller. The PEEP valve may also be but is not limited to control by voice coil. Exhaust gases exit through the expiratory connector 44-C2 to atmosphere. Further features are offered including pressurised oxygen for a nebuliser and cuff-pressure control system.

[0156] When the anaesthesia module is connected to the ventilator module. In one embodiment, the oxygen delivery system described above (reference to V-Gas conditioning) is used to provide oxygen into the device. In another embodiment of the invention, an additional supply of pressurised oxygen can be provided as explained following. Using a separate supply of oxygen may be preferred as connections to different pipeline or cylinders are not required to be made/unmade and because the flows through flow control valves (e.g. 11-PRV1) are different for dynamically mixing systems required for the ventilator only function (up to 200 SLPM) whereas flows of 0-20 SLPM are required for closed-circuit anaesthesia, with greater accuracy at low flows of 150-500 ml/min.

[0157] Pressurised oxygen, air and nitrous oxide are delivered via identical pressure control and monitoring systems as described for “V-Gas Conditioning” to deliver filtered, pressurised gas at 2.6 bar to a flow control valve. In this case, a piezo-electric flow controller is used to deliver gas into the patient circuit at the rate demanded by the control system, although other methods familiar to those experienced in the state of the art can be used. A bypass oxygen supply is provided via manual flowmeter 11-FM2 and safety isolation valve 11-SV1.

[0158] Volatile anaesthetic can either be added by the incorporation of a vapouriser or by the use of a volatile injection system downstream of the multi-gas outlet. Gas is drawn through the one way valve 44-CV2 and connection between the anaesthesia and ventilator modules 44-C3 into the ventilator module for delivery to the patient. Exhaled gases return through the expiratory port 44-C2 to the CO.sub.2 absorber 44-CO2A and volume reservoir bag 44-BAG to complete the closed circle circuit. In this way, exhaled gases return via the PEEP valve to the bag. These gases are then drawn into the turbine and delivered into the inspiratory limb following additions of further air/oxygen/nitrous oxide/volatile anaesthetic as demanded by the anaesthesia controller. Any excess circuit volume is wasted through the Adjustable Pressure Limiting valve (APL-A-APL). This valve has a minimum value of 2cmH.sub.2O to ensure the circuit remains filled. When the turbine is in operation, the APL valve is set to minimum. If the user wants to manually ventilate the patient, the APL valve is turned to the desired pressure value by the user. This switches off the turbine and will pressurise the circuit as demanded by the user via the APL valve. Exhaust gases pass to a two position, two-way valve 44-EV1 that directs waste gas to the active scavenging system via 44-C5 or a passive, recycling scavenging system via 44-C4. Positive pressure relief valve 44-PRV2 protect the patient circuit from overpressure in the case of occlusion and a negative pressure relief valve 44-PRV2 protects the patient circuit from excess negative pressure from the active scavenging system. Condensation of gases with moisture from the patient, humidifier or CO.sub.2 absorber is prevented by the heating of the anaesthesia manifold by Man-Htg1 under the control and monitoring of temperature transducers Man-T1/T2. Patient circuit humidity and temperature are monitored by 44-H1 and pressure in the anaesthesia manifold (pre-turbine) by 44-PT2.

[0159] FIG. 2

[0160] The ventilator component on the ventilator processor interfaces with the I/O to manage the ventilator module. The visualisation controller provides an interface to the network, the Primary UI and also to the Secondary UI, but in the latter case, this is provided through the docking port that interfaces between the ventilator and anaesthesia modules. The Anaesthesia Processor interfaces with the I/O in the anaesthesia module and also the Anaesthesia Module UI to display important parameters specific to the Anaesthesia module. Communication between the processors is via CANBUS. The CANBUS connection is passed via the docking port between the anaesthesia and ventilator modules to allow the modules to work together. Power in the anaesthesia module is provided from a separate power controller (not shown) in the anaesthesia module. This provides power to the power controller in the ventilator module through the docking station (not shown). Likewise, a networking connection is passed from the anaesthesia module to the ventilator module to charge the portable ventilator module batteries when the ventilator module is docked to the anaesthesia module.

[0161] FIG. 3

[0162] The ventilator module 1 is docked to the anaesthesia module. The anaesthesia module includes a container for Carbon dioxide absorber 3, a reservoir bag 2, a secondary display 4, height adjust capabilities for the anaesthesia docking port, secondary display and table work area 5, a pole to attach intravenous pump racks 6, warming devices 7 or other ancillaries. The base 9 houses batteries and power connections, rails at the side 8 protect the device envelope and enable easy movement. The ventilator module houses the standard ventilator breathing system inspiratory and expiratory connections. These are in recessed housings to prevent damage (they are male connections) in the location shown 10 (actual connections not shown in model-only location).

[0163] FIG. 4

[0164] The ventilator module 21 is undocked from the anaesthesia module 22. The ventilator module is portable, with carrying handles 23 and the primary touchscreen user interface 24. A positioning recess 26 in the anaesthesia module ensures stability when the ventilator module docks to the anaesthesia module docking port 27. Volatile anaesthesia may be provided by a volatile anaesthetic-specific removable cassette 25 located within the anaesthesia module. The anaesthesia module also contains backup gas cylinders 28 and connections to pipeline gas supplies (not shown).

[0165] FIG. 5

[0166] The ventilator module location strip 31 matches to the anaesthesia module location recess (see FIG. 4). The male docking port 32 of the ventilator module is protected by the protrusion of the support frame 33. Other exposed buttons and rotary encoder are contained on an easily removable section 34 so that they can be replaced quickly if damaged and will not damage the main unit.

[0167] FIG. 6

[0168] A single ventilator module with networking, data storage and Artificial Intelligence (AI)/Machine Learning (ML) capability is used across critical care areas to provide uninterrupted data capture and analysis. Additional functionality is provided by a docking port that enables extra display of information in Intensive Care Units (ICU), Emergency Department (ED), Wards, Radiology and Recovery and docking with an anesthesia module allows the provision of volatile anaesthesia for surgery in theatres with the potential to integrate with volatile anaesthetic recycling services to reduce necessary infrastructure and reduce environmental pollution. At all stages, transfer is with a fully-functional ICU-grade ventilator and a high frequency data record is maintained with AI/ML-based analysis.

[0169] AI/ML in devices and their connection to the network enables the passage of data and analysis across the network to modules in critical care so that patients at risk of deterioration can be identified to experienced clinicians, their data and analysis reviewed and acted upon. Data transfer and analysis also allows review of issues in one theatre by another and the review of patients in recovery by a device in theatre (for example, a patient waking up would be reviewed by the anesthetist in theatre).

[0170] FIG. 7

[0171] An AI module is inserted into a compatible ward-based monitor. The monitor and AI module are then used to monitor a patient on the ward. The AI module stores patient information and performs analysis including the ability to alert expert clinicians to the ‘need to rescue’. This refers to the need to review a deteriorating patient. When the patient needs critical care intervention, the AI module is removed and inserted into the ventilator module, bringing with it patient information, history and data. This ventilator module is used in ICU and can also dock with an anaesthesia module to provide anaesthesia in theatre. It is then returned to the ward-based monitor when the episode of critical care is complete.

[0172] FIG. 8

[0173] In ventilator only mode. Oxygen from a cylinder or pipeline supply, is supplied through a filter 11-F1 with monitoring by pressure transducer 11-PT1. The flow control valve 11-PFV1 regulates flow into the patient circuit through the mass flow meter (11-PT2 atmospheric pressure, 11-TT1 temperature transducer, 11-FT1 flowmeter). Ambient air is drawn into circuit through the 3 port 2 position valve 11-3P2PV1 and filter 22-F1 under monitoring from 22-PT1. Flow control valve 22-PTV1 and the mass flow meter (22-PT2, 22-TT1, 22FT1) regulate flow generated by the turbine 33-T1 under the control of inspiratory flowmeter 33-FT1 and near-patient differential pressure transducer 44-DPT1. Oxygen concentration is monitored by 33-OT1. Electronically-controlled Patient pressure relief and power-off gas supply is provided by 33-NOSV1, with a mechanical relief valve 33-PRV1. Air is filtered by 33-F1. A standard ISO connector connects to the ventilator breathing system. Near-patient flowmeter is provided prior to the near-patient differential pressure transducer. Exhaled gas returns to the ISO-standard connection port, exhaled and bypass flow is measured by the flowmeter 44-FT1 with circuit pressure controlled by the PEEP valve 33-PEEPV1. This may be controlled by air loaded diaphragm (may be from a dual valve pressure regulator 33-EPCD) or by voice coil. In ventilator-only mode, exhaust gas leaves from the exhaust port following the PEEP valve 44-PEEPV1.

[0174] When the anaesthesia module is connected, the circuit is closed. Exhaust gases from the PEEP valve 44-PEEPV1 pass to the CO.sub.2 absorber 44-CO2ABS1 and to the reservoir bag 44-BAG1. Recirculated gases pass through the normally-closed valve 33-NCSV1 to return to the turbine 33-T1. Ambient air is no longer drawn into the patient circuit by the turbine 33-T1 as the 3 port 2-position valve 11-3P2PV1 is directed instead to compressed air stored in 11-V1. Compressed air is provided by the air compressor 44-DP1 to a pressure of 4-6 bar. Preferably 44-DP1 is a diaphragm pump, although other pumps familiar to those skilled in the art can be used. As an alternative embodiment, a turbine may be used and the pressure in 11-V1 be reduced to 20-100 mbar. Ambient air can be drawn to into the inlet of the pump/turbine from atmosphere or from exhaust gases. Exhaust gases are passed from the patient circuit to 44-DP1 by the action of 44-3P2PV1 when the controller detects excess pressure in the circuit following the PEEP valve (44-CO2ABS1, 44-BAG1). Exhaust gases are filtered first by 44-F1. During exhaust, gases pass through 44-3P2PV1 to the pump 44-DP1 through the three-port valve 44-3P2PV2 to Nafion water-selective tubing 44-MF1 to remove water vapour from exhaust gases. Dried gas passes to the capture chamber 44-V1 at pressure of atmosphere to 4 bar controlled by the flow control valve 44-PFV1 with scrubbed waste gases passing to atmosphere. The capture chamber contains an absorbent material such as silica, activated carbon, aerogel (silica or carbon-based), graphene, zeolite or metal-organic framework (MOF). The volatile anaesthetic is captured onto the capture material at pressure. At the end of the operation, when the anaesthesia machine is no longer being used, the capture chamber 44-V1 is purged of volatile anaesthetic first by passing through 44-MF1, 44-3P2PV2, 44-3P2PV1 and being directed to the removable capture canister 44-V2, in which dried volatile anaesthetic is absorbed with scrubbed waste gases passing to atmosphere. A vacuum can be provided by pump 44-DP1 operating in reverse to complete volatile anaesthetic desorption from 44-V1 and transfer to 44-V2. The storage canister 44-V2 can be removed for further recycling according to other prior art (for example WO2016/027097 and WO2017/144879). By this method, the pump 44-DP1 can perform three functions at different stages of the anaesthesia case: [0175] 1. Air compression to provide compressed air to be added to the patient circuit (mostly before case starts and the machine is turned on or rarely and intermittently when the exhaust is not active) [0176] 2. Dehumidification of exhaust gases and storage of volatile anaesthetic in chamber 44-V1 (when 44-BAG1 pressure high during the operation) [0177] 3. Transfer of stored volatile anaesthetic from 44-V1 to a removable anaesthetic recycling canister 44-V2 at the end of the operation or day (depending on the filling status of the absorbent canister).

[0178] FIG. 9

[0179] The patient circuit is arranged in the same way as FIG. 6, to provide modular anaesthesia and ventilation so that the device may perform as a stand-alone portable ventilator using ambient air and pressurised oxygen and an anaesthesia machine where the patient circuit is closed and air and oxygen are both provided from a pressurised source. The difference between FIGS. 6 and 7 is the configuration of the waste processing and recycling system and the provision of pressurised air in the anaesthesia module

[0180] Exhaled gases pass through the PEEP valve 44-PEPV1 in the ventilator module into the anaesthesia module. Excess pressure in the circuit leads to wasting of exhaust gases through filter 44-F1 and valve 44-3P2PV1 to the pump or turbine 44-DP1. This pressurises the exhaust gases to 4 bar through the Nafion membrane 44-MF1 to remove moisture and then to the collection chamber 44-V1 where absorbent material as described for FIG. 6 is located. Nafion moisture removal (uses PEEP waste O2 as drying gas). The absorbent material scrubs the dried exhaust gases of volatile anaesthetic. Scrubbed waste gas above 4 bar spills over the proportional valve 44-PFV1 and is subsequently directed to atmosphere as waste. Waste air/oxygen stripped of anaesthetic from exhaust passes into theatre air. Following the completion of the case, the proportional valve 44-PFV1 opens to gradually transfer the contents of the collection chamber 44-V1 to the removable absorbent canister 44-V2, as used by recycling systems for example (for example WO2016/027097 and WO2017/144879). Recycling canister (44-V2) collects evacuated contents off 44-V1 at end of case. Before the start of the case or if the air pressure is low in the pressurised air reservoir 11-V1, the pump 44-DP1 compresses air taken from atmosphere through 44-3P2PV1 and passes it to 44-3P2PV2 through the connection 11-C1 and to the air reservoir 11-V1 at 4 bar. If required, 11-V1 can be vented to atmosphere by passing its contents through 11-NCSV1.

[0181] Compressed air may be provided during anaesthesia mode.

[0182] 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 idealized or overly formal sense unless expressly so defined herein.

[0183] 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.