WO2023026228A1

WO2023026228A1 - A system and method for bio-containment of a patient

Info

Publication number: WO2023026228A1
Application number: PCT/IB2022/057963
Authority: WO
Inventors: Sabrina Menghini
Original assignee: Inmm S.R.L.
Priority date: 2021-08-27
Filing date: 2022-08-25
Publication date: 2023-03-02
Also published as: IT202100022475A1

Abstract

A system (1) for bio-containment of a patient, comprises: a negative pressure chamber (10), which includes a wall system (101), defining an internal space (109) and which is provided with an air inlet (102) and an air outlet (103); a pressure regulating system (104) for generating and holding a negative pressure inside the internal space (109); a sensing system (20), including a plurality of ambient sensors, for detecting a corresponding plurality of ambient signals representative of an ambient condition inside the internal space (109); a control unit (30), including a memory (301) and a processor (302), connected to the sensing system (20) for receiving the plurality of ambient signals. The control unit is programmed for deriving a plurality of ambient parameters (303) from the plurality of ambient signals and for processing the plurality of ambient parameters (303) and deriving an alert indicator (305) for a person, representative of a need for intervention on the bio-containment system (1).

Description

DESCRIPTION

A SYSTEM AND METHOD FOR BIO-CONTAINMENT OF A PATIENT

Technical field

This invention relates to a system for the bio-containment of one or more patients and a method for providing bio-containment of one or more patients.

Background art

To be able to safely manage cases of highly transmissible infectious diseases, a patient with a contagious disease must be isolated from the surrounding environment so as to protect the health and safety not only of the patient but also of the operators who come into contact with the patient. In particular, known in the prior art in the field of systems for isolating patients with contagious diseases is technology for creating what is known as a bio-containment environment, where the air inside such an environment is brought to and held at a negative pressure, that is to say, a pressure lower than the pressure of the environment outside it.

More specifically, the air in the bio-containment environment is brought to and held at a negative pressure by extracting and filtering the air before expelling it into the outside environment.

Isolating one or more patients suffering from a contagious disease may be necessary, for example, when transporting the patients from their homes to a hospital. Furthermore, such bio-containment environments may constitute a quick and economical alternative to the construction of new hospitals, in the event of hospital bed shortages.

To control the bio-containment environment and a patient inside it, the biocontainment environment may also include a sensing system for detecting the ambient parameters, so as to monitor the ambient conditions, and the body or vital parameters, so as to monitor the state of the patient's health. The sensing system may also interact with a control system to adjust the ambient conditions on the basis of the conditions detected by the sensing system.

An example of such a technology is described in patent documents CN1 1 1441618B and US20040035416; other examples may be found in patent documents US7479103B2, US5975081 A, US2003/205230A1 and US5503143A.

However, when a bio-containment environment comprises a large number of ambient parameters and body parameters to be monitored, or, as in the case of a pandemic, when bio-containment is necessary for a plurality of patients, a healthcare operator may not have the expertise required to monitor and deal with emergencies linked to the bio-containment environment or the health of the patient or plurality of patients. This problem is particularly serious when the patient or the plurality of patients have a highly contagious disease that can spread at a speed that requires rapid, emergency containment measures.

Aim of the invention

The aim of this invention is to provide a bio-containment system and method for one or more patients to overcome the above mentioned disadvantages of the prior art. In particular, the aim of this disclosure is to provide a biocontainment system for one or more patients and a method for creating a bio-containment environment, to allow a healthcare operator to monitor and manage an emergency rapidly and efficiently.

This aim is fully achieved by the system and method of this disclosure as characterized in the appended claims.

The system for bio-containment of a patient comprises a negative pressure chamber. The chamber may be configured to accommodate one or more patients.

The negative pressure chamber includes a wall system that defines an internal space. For example, the wall system may include a plurality of fixed walls, or the wall system may include an enclosure movable between an open configuration and a closed configuration. The open configuration, for example, allows a patient to be accommodated inside a negative pressure chamber. The closed configuration, for example, allows creating, inside an internal space, an environment that is isolated from the outside environment.

The negative pressure chamber may include an air inlet. The air inlet may be configured to allow air from the outside environment into an internal space of a negative pressure chamber. The negative pressure chamber may include an air outlet. The air outlet may be configured to allow air to flow out of an internal space towards the outside environment. The negative pressure chamber may include a pressure regulating system. The pressure regulating system may be configured to create and/or hold a negative pressure inside an internal space; the pressure regulating system may be configured to expel air into the outside environment through an air outlet. For example, the pressure regulating system may have a ventilating system such as a pump, for example. The pump may be configured to extract air from an internal space. The pump may be connected to an air outlet. The pump may extract the air from an internal space and expel it to the outside environment through an air outlet. The pressure regulating system may have an electrical power unit. In an embodiment, the electrical power unit is supported by a battery and is connected to a ventilating system to drive it. Through the pressure regulating system it is possible to create and hold a pressure inside a chamber at a level below the pressure of an environment outside the chamber. The lower pressure in the chamber ensures the internal space remains isolated and prevents dangerous biological agents from escaping uncontrolledly.

The negative pressure chamber may include a filter, configured to filter the air expelled through an air outlet by a pressure regulating system.

The system for bio-containment of one or more patients may comprise a sensing system. The system may comprise an electric battery. For example, the electric battery may be configured to power a sensing system.

The sensing system may be configured to detect a plurality of signals. The sensing system may include a plurality of sensors. The plurality of sensors may be configured to detect a corresponding plurality of signals. The plurality of sensors may include a plurality of ambient sensors, configured to detect a corresponding plurality of ambient signals; the ambient signals may be representative of an ambient condition inside the internal space.

The plurality of ambient sensors may comprise one or more of the sensors listed below: a differential pressure sensor, to detect a differential pressure parameter, the differential pressure parameter being defined as a difference between the pressure inside the internal space and the pressure outside the internal space; a temperature sensor, to detect a temperature parameter, the temperature parameter being defined as a temperature of the air inside the internal space; a carbon dioxide sensor, to detect a carbon dioxide parameter, the carbon dioxide parameter being defined as an amount of carbon dioxide in the air inside the internal space; a humidity sensor, to detect a humidity parameter, the humidity parameter being defined as a humidity of the air inside the internal space; an electric battery charge sensor to detect a charge parameter of an electric battery, the charge parameter of an electric battery being defined as the level of charge of an electric battery included in a bio-containment system; an electric battery voltage sensor, to detect a voltage parameter of an electric battery, the electric battery voltage parameter being defined as a voltage at an electric battery included in a bio-containment system.

The plurality of sensors may include a plurality of body sensors, configured to detect a corresponding plurality of body signals; the body signals may be representative of a condition of a patient's body.

The plurality of body sensors may comprise one or more of the sensors listed below: a blood pressure sensor, to detect a blood pressure parameter, the blood pressure parameter being defined as a patient's blood pressure; a body temperature sensor, to detect a body temperature parameter, the body temperature parameter being defined as a patient's body temperature; a blood oxygen saturation sensor, to detect an oxygen saturation parameter, the oxygen saturation parameter being defined as a level of oxygen saturation in a patient's blood; a heart rate sensor, to detect a heart rate parameter, the heart rate parameter being defined as a patient's heart rate.

The sensing system has the advantage of monitoring the state of the negative pressure chamber and/or the state of health of the patient accommodated therein.

The negative pressure chamber may include one or more nozzles; the one or more nozzles may be configured to connect one or more sensors of a plurality of sensors to an internal space of a negative pressure chamber.

The bio-containment system may comprise a control unit. The control unit may include a memory; the control unit may include a processor. In an example embodiment, the control unit is connected to a sensing system to receive a plurality of signals. In an example embodiment, the control unit receives a plurality of signals and derives a plurality of parameters from the plurality of signals. In an example embodiment, the control unit is connected to a sensing system to receive a plurality of ambient signals; the control unit may be programmed to derive a plurality of ambient parameters from the plurality of ambient signals. In an example embodiment, the control unit is connected to a sensing system to receive a plurality of body signals; the control unit may be programmed to derive a plurality of body parameters from the plurality of body signals. The control unit may be programmed to derive an alert indicator, representative of a need for intervention on a bio-containment system, for one person, for example, for a healthcare operator. By alert indicator is meant an indication, for a healthcare operator, regarding a functional state and/or a possible state of need for intervention on a bio-containment system of a patient and/or regarding a state of health of a patient accommodated therein.

In an example embodiment, the control unit processes a plurality of ambient parameters to derive an alert indicator for a person. In an example embodiment, the control unit processes a plurality of body parameters to derive an alert indicator for a person, representative of a need for intervention on the patient. Thus, the control unit is programmed to derive the alert indicator as a function of the plurality of ambient parameters; preferably, the control unit is programmed to derive the alert indicator as a function of both the plurality of ambient parameters and the plurality of body parameters.

The memory may contain a plurality of reference data items and a plurality of predetermined categories for an alert indicator. The control unit may be programmed to process a plurality of parameters, for example, ambient parameters, or body parameters, according to a plurality of reference data items. The control unit may be programmed to attribute an alert indicator to a category of a plurality of predetermined categories. The control unit may attribute an alert indicator to a category of a plurality of predetermined categories, responsive to a predetermined condition of a plurality of predetermined conditions satisfied by parameters with respect to reference data.

In an example embodiment, the memory contains first reference data and at least a first and a second predetermined category for an alert indicator. The control unit may be programmed to process parameters according to first reference data. The control unit may attribute an alert indicator to a first category, responsive to a first predetermined condition satisfied by parameters with respect to first reference data.

In an example embodiment, the memory contains first reference data for a plurality of ambient parameters. For example, the ambient parameters may include a differential pressure parameter, a carbon dioxide parameter, an air flow parameter and an electric battery charge parameter. The memory may contain a first and a second predetermined category for an alert indicator. One or more parameters of a plurality of ambient parameters may satisfy a first predetermined condition with respect to first reference data, where the first predetermined condition is representative of a critical working condition, that is, a working condition of the bio-containment system which requires the immediate intervention of a person, for example, a healthcare operator. For example, a first predetermined condition representative of a critical working condition (that is, a working condition of the bio-containment system which requires the immediate intervention of a person, for example, a healthcare operator) satisfied by one or more ambient parameters, may include one of the following first predetermined conditions: differential pressure parameter <10 Pa, air flow parameter <5m3/h, carbon dioxide parameter >1500 ppm, electric battery charge parameter <30%.

The memory may contain a first category for an alert indicator, this first category being defined as "critical". The control unit may be programmed, according to first reference data, to attribute an alert indicator to a "critical " category responsive to one of the first predetermined conditions satisfied by one or more ambient parameters with respect to first reference data.

In an example embodiment, the memory contains second reference data and a third predetermined category for an alert indicator. The control unit may be programmed to process parameters according to second reference data. The control unit may attribute an alert indicator to a second or a third category, responsive to a second or a third predetermined condition satisfied by parameters with respect to second reference data. In an example embodiment, the memory contains second reference data for a plurality of ambient parameters. For example, the ambient parameters may include a differential pressure parameter, a carbon dioxide parameter, an air flow parameter and an electric battery charge parameter, a temperature parameter, a humidity parameter and an electric battery voltage parameter. One or more parameters of a plurality of ambient parameters may satisfy a second predetermined condition with respect to second reference data, where the second predetermined condition is representative of an abnormal working condition, that is, a working condition of the bio-containment system which requires the attention of a person, for example, a healthcare operator. For example, a second predetermined condition representative of an abnormal working condition (that is, a working condition of the bio-containment system which requires the attention of a person, for example, a healthcare operator) satisfied by one or more ambient parameters, may include one of the following second predetermined conditions: differential pressure parameter <40 Pa, air flow parameter <10m3/h, carbon dioxide parameter >1000 ppm, electric battery charge parameter <75%, temperature parameter <24°C or > 28°C, humidity parameter <40%RH or >80%RH, electric battery voltage parameter <10 or >15 V.

One or more ambient parameters of a plurality of ambient parameters may satisfy a third predetermined condition, where the third predetermined condition is representative of a normal working condition, that is, a working condition of the bio-containment system which does not require the attention of a person, for example, a healthcare operator.

For example, a third predetermined condition representative of a normal working condition (that is, a working condition of the bio-containment system which does not require the attention of a person, for example, a healthcare operator) satisfied by each of the ambient parameters, may include one of the following third predetermined conditions: differential pressure parameter >40 Pa, air flow parameter >10m3/h, carbon dioxide parameter <1000 ppm, electric battery charge parameter >75%, temperature parameter between 24°C and 28°C, humidity parameter between 40%RH and 80%RH, electric battery voltage parameter between 10 and 15 V.

The memory may contain a second category for an alert indicator, the second category being defined as "abnormal" and a third category for an alert indicator, the third category being defined as "normal. The control unit may be programmed, according to second reference data, to attribute an alert indicator to the "abnormal" category responsive to a second predetermined condition satisfied by one or more ambient parameters with respect to second reference data. The control unit may be programmed, according to second reference data, to attribute an alert indicator to the "normal" category responsive to a third predetermined condition satisfied by each of the ambient parameters with respect to second reference data.

The designations "critical", "abnormal" and "normal" for the alert indicators may be equivalently replaced by, for example, a colour code system where red, yellow and green correspond to "critical", "abnormal" and "normal", respectively.

Deriving an alert indicator has the advantage of providing a healthcare operator with a concise analysis of the ambient conditions, that is, the state of the negative pressure chamber. This concise analysis simplifies and speeds up the healthcare operator's task of monitoring, especially when the number of ambient parameters to be monitored simultaneously is particularly large. In effect, depending on the alert indicator output from the processor, the operator is informed as to whether or not a bio-containment system needs attention. In an example embodiment, the memory contains a plurality of predetermined categories for a diagnostic indicator. The diagnostic indicator may be representative of an undesirable working condition of the system; by "undesirable working condition" of the system is meant for example, a service disruption of the bio-containment system. The control unit may be programmed to process a diagnostic indicator. The control unit may be programmed to attribute a diagnostic indicator to one or more predetermined categories of the plurality of predetermined categories. The control unit may be programmed to attribute a diagnostic indicator to one or more predetermined categories of the plurality of predetermined categories, based on a plurality of parameters. For example, the control unit may be programmed to attribute the diagnostic indicator to one or more predetermined categories of a plurality of predetermined categories, based on a plurality of body parameters. For example, the control unit may be programmed to attribute the diagnostic indicator to one or more predetermined categories of a plurality of predetermined categories, based on a plurality of ambient parameters.

One or more categories of the plurality of predetermined categories for the diagnostic indicator may be selected from the following list: low level of charge of an electric battery, break in wall system; shutdown of an electrical power unit; opening of a nozzle.

The purpose of attributing a diagnostic indicator representative of an undesirable working condition of the system is to inform a healthcare operator, for example, of a system service disruption, allowing them to deal with the disruption promptly and efficiently.

The control unit may attribute the diagnostic indicator to one or more predetermined categories through a machine-learned model. For example, the control unit may feed the plurality of ambient parameters to a machine- learned model. The machine-learned model may be trained to attribute a diagnostic indicator to predetermined categories.

The machine-learned model may be trained to attribute a diagnostic indicator to predetermined categories through a classification algorithm. By "classification algorithm" is meant an algorithm that categorizes, that is to say, an algorithm that assigns an object, for example, a diagnostic indicator, to a predetermined category. For example, the classification algorithm may assign a diagnostic indicator to a predetermined category. By way of example, the classification algorithm may comprise a plurality of classification trees. Each classification tree of the plurality of classification trees may include a plurality of nodes, where each node of the plurality of nodes represents a predetermined condition for a parameter; each classification tree may include a plurality of branches, where each branch represents a predetermined condition satisfied by a parameter. Each classification tree may include a plurality of terminations, where each termination represents a predetermined category. The classification algorithm assigns an object, that is, a diagnostic indicator, to the most frequent predetermined category of the predetermined categories of the plurality of classification trees.

In an example embodiment, the system comprises an alerting system. The control unit may be programmed to derive an alerting signal, based on an alert indicator. The control unit may be programmed to derive an alerting signal, based on ambient parameters and/or on body parameters. The control unit may be programmed to derive an alerting signal, based on a diagnostic indicator. The control unit may be connected to an alerting system to send an alerting signal to the alerting system.

In an example embodiment, the system comprises a database. The control unit may be connected to a database to store ambient parameters and/or body parameters in the database. The control unit may be connected to a database to store alert indicators in the database. The control unit may be connected to a database to store diagnostic indicators in the database.

In an example embodiment, the system comprises a screen. The control unit may be connected to the screen to display ambient parameters and/or body parameters on the screen. The control unit may be connected to a screen to display alert indicators on the screen. The control unit may be connected to a screen to display diagnostic indicators on the screen.

In an example embodiment, the system comprises a plurality of negative pressure chambers and a corresponding plurality of sensing systems for bio-containment of a plurality of patients.

In an example embodiment, the system comprises a control unit connected to each sensing system of a plurality of sensing systems.

In an example embodiment, the system comprises a plurality of control units and each control unit of the plurality of control units is connected to a corresponding plurality of sensing systems.

The purpose of the plurality of sensing systems is to monitor a plurality of ambient conditions of a plurality of negative pressure chambers and/or a plurality of bodily conditions of a plurality of patients.

For each negative pressure chamber of a plurality of negative pressure chambers, the control unit may be programmed to process a respective plurality of parameters. For each negative pressure chamber of a plurality of negative pressure chambers, the control unit may be programmed to derive a respective alert indicator from a plurality of parameters. For each negative pressure chamber of a plurality of negative pressure chambers, the control unit may be programmed to derive a respective diagnostic indicator. In particular, the memory may contain a plurality of predetermined categories for a diagnostic indicator, representative of an undesirable working condition for the system. For each negative pressure chamber of the plurality of negative pressure chambers, the control unit is also programmed to attribute the diagnostic indicator to one or more predetermined categories of the plurality of predetermined categories, based on the respective plurality of ambient parameters; the mode of attribution and the predetermined categories may be according to one or more aspects of this disclosure. For example, the control unit may be programmed to generate image data to be displayed on a screen. The function of the image data is to provide a supervisory operator (for example, a hospital operator) with a synoptic representation of the situation of a multiplicity of chambers. That way, it is easier for the operator to take action where there is a more urgent need because the conditions in the chamber and the conditions of the patient, as a whole, are not good or acceptable. The system is also programmed to allow the operator to choose (from a predetermined selection of different options) the type of information to be displayed for each chamber and/or the mode of graphically representing the information. This further facilitates the task of monitoring the plurality of chambers. It should be noted that monitoring can be conducted remotely from a site that is remote from the building or structure where the chambers are located.

The image data may be representative of a chart. The chart may illustrate a graphical indication of parameters of a plurality of negative pressure chambers. The chart may illustrate a graphical indication of alert indicators of a plurality of negative pressure chambers. The chart may illustrate a graphical indication of diagnostic indicators of a plurality of negative pressure chambers.

In an example embodiment, the chart may include a plurality of configurations.

For example, in a configuration of a plurality of configurations, the chart may illustrate, in combination, alert indicators, parameters and diagnostic indicators for a plurality of negative pressure chambers. For example, in a configuration of a plurality of configurations, the chart may illustrate, in combination, an alert indicator, parameters and a diagnostic indicator for one negative pressure chamber.

For example, in a first configuration, the chart may illustrate a graphical indication of diagnostic indicators and/or of one or more parameters of the plurality of parameters and/or of the diagnostic indicators of a plurality of negative pressure chambers. In a second configuration, for example, the chart may illustrate a graphical indication of a diagnostic indicator, of an alert indicator and of one or more parameters of one negative pressure chamber. For example, in a third configuration, the chart may illustrate a graphical indication of one or more ambient parameters of a negative pressure chamber, and one or more body parameters of a patient accommodated in a negative pressure chamber.

In an embodiment, the chart comprises a plurality of configurations, where, in a first configuration, the chart illustrates a plurality of alert indicators, a plurality of diagnostic indicators and a plurality of ambient parameters of the respective plurality of negative pressure chambers, and in a second configuration, the chart illustrates an alert indicator, a diagnostic indicator and a plurality of ambient parameters of one negative pressure chamber of the plurality of negative pressure chambers.

The control unit may be programmed to display a plurality of configurations of a chart on a screen. The control unit may be programmed to switch the chart from one configuration to another of the plurality of configurations, for example, from the first configuration to the second configuration and vice versa.

In an example embodiment, where the system comprises a plurality of negative pressure chambers and the control unit is programmed to process the image data representative of a chart illustrating a graphical indication of the alert indicators and/or of the diagnostic indicators of the plurality of negative pressure chambers through the image data, the operator is informed of the ambient conditions of the plurality of negative pressure chambers; thus, through the graphical indication of the alert indicators, it is easier for the healthcare operator to decide, for example, an order of priority for a plurality of needs for intervention on a bio-containment system comprising a plurality of negative pressure chambers, thus allowing efficient management of a plurality of patients.

This disclosure also provides a method for providing bio-containment of a patient. The method comprises a step of creating a negative pressure chamber which may comprise a wall system defining an internal space. The wall system may include a plurality of fixed walls, or it may include an enclosure movable between an open configuration and a closed configuration. The open configuration, for example, allows a patient to be accommodated inside a chamber. The closed configuration, for example, allows creating, inside an internal space, an environment that is isolated from the outside environment.

The method comprises a step of generating a negative pressure inside an internal space. The method may comprise a step of holding a negative pressure inside an internal space. The step of generating and holding a negative pressure may include a step of taking air in through an air inlet provided in a negative pressure chamber. The step of generating and holding a negative pressure may include a step of letting air out through an air outlet provided in a negative pressure chamber. The step of generating and holding a negative pressure may include a step of moving the air from an air inlet to an air outlet. The step of moving the air from an air inlet to an air outlet may be carried out by a pressure regulating system. In an example embodiment, the step of moving the air is carried out by a ventilating system such as a pump, for example. The method may include a step of driving a ventilating system by means of an electrical power unit.

The method may include a step of filtering through a filter located on an air outlet.

The method may include a step of making a sensing system; the method may comprise providing an electric battery. For example, the method may include a step of powering a sensing system through an electric battery. The method may include a step of configuring a sensing system and a step of providing a plurality of sensors to detect a plurality of signals. The method may include a step of detecting a plurality of signals by means of a plurality of sensors.

The method may include a step of providing a plurality of ambient sensors to detect a plurality of ambient signals. The method may include a step of detecting a plurality of ambient signals, representative of an ambient condition inside an internal space, by means of a plurality of ambient sensors.

In an example embodiment, the method comprises a step of selecting a plurality of ambient sensors from one or more of the sensors listed below: a differential pressure sensor, to detect a differential pressure parameter, the differential pressure parameter being defined as a difference between the pressure inside the internal space and the pressure outside the internal space; a temperature sensor, to detect a temperature parameter, the temperature parameter being defined as a temperature of the air inside the internal space; a carbon dioxide sensor, to detect a carbon dioxide parameter, the carbon dioxide parameter being defined as an amount of carbon dioxide in the air inside the internal space; a humidity sensor, to detect a humidity parameter, the humidity parameter being defined as a humidity of the air inside the internal space; an electric battery charge sensor to detect a charge parameter of an electric battery, the charge parameter of an electric battery being defined as the level of charge of an electric battery included in a bio-containment system; an electric battery voltage sensor, to detect a voltage parameter of an electric battery, the electric battery voltage parameter being defined as a voltage at an electric battery included in a bio-containment system.

The method may include a step of providing a plurality of body sensors to detect a plurality of body signals. The method may include a step of detecting a plurality of body signals, representative of a condition of a patient's body, by means of a plurality of body sensors.

In an example embodiment, the method comprises a step of selecting a plurality of body sensors from one or more of the sensors listed below: a blood pressure sensor, to detect a blood pressure parameter, the blood pressure parameter being defined as the patient's blood pressure; a body temperature sensor, to detect a body temperature parameter, the body temperature parameter being defined as the patient's body temperature; a blood oxygen saturation sensor, to detect an oxygen saturation parameter, the oxygen saturation parameter being defined as a level of oxygen saturation in the patient's blood; a heart rate sensor, to detect a heart rate parameter, the heart rate parameter being defined as the patient's heart rate.

The method may comprise a step of connecting one or more sensors of the plurality of sensors to the negative pressure chamber through one or more nozzles.

In an example embodiment, the method comprises a step, performed by a control unit, of receiving a plurality of signals; for example, the method may comprise a step, performed by a control unit, of deriving a plurality of parameters from a plurality of signals;

In an example embodiment, the method comprises a step, performed by a control unit, of receiving a plurality of ambient signals; for example, the method may comprise a step, performed by a control unit, of deriving a plurality of ambient parameters from a plurality of ambient signals; in an example embodiment, the method comprises a step, performed by a control unit, of receiving a plurality of body signals; for example, the method may comprise a step, performed by a control unit, of deriving a plurality of body parameters from a plurality of body signals.

The method may comprise a step, performed by a control unit, of deriving an alert indicator for a person, representative of a need for intervention on a bio-containment system.

In an example embodiment, the method comprises a step, performed by a control unit, of processing a plurality of body parameters and deriving an alert indicator. The method may include a step, performed by a control unit, of accessing a memory containing a plurality of reference data items and a plurality of predetermined categories for an alert indicator. The method may include a step, performed by a control unit, of processing a plurality of parameters, for example, ambient parameters, or body parameters, according to a plurality of reference data items. The method may include a step, performed by a control unit, of attributing an alert indicator to a category of a plurality of predetermined categories, responsive to a predetermined condition of a plurality of predetermined conditions satisfied by parameters with respect to reference data.

In an example embodiment, the method may include a step, performed by a control unit, of accessing a memory containing first reference data items and at least a first and a second predetermined category for an alert indicator. The method may comprise a step, performed by a control unit, of processing parameters according to the first reference data. The method may comprise a step, performed by a control unit, of attributing an alert indicator to a first category, responsive to a first predetermined condition satisfied by parameters with respect to first reference data.

In an example embodiment, the method includes a step, performed by a control unit, of accessing a memory containing first reference data for a plurality of ambient parameters, which may include, for example, a differential pressure parameter, a carbon dioxide parameter, an air flow parameter and an electric battery charge parameter. The method may include a step, performed by a control unit, of accessing a memory containing at least a first and a second predetermined category for an alert indicator. The method may comprise a step, performed by a control unit, of processing ambient parameters according to first reference data. The method may comprise a step, performed by a control unit, of attributing an alert indicator to a first category, responsive to a first predetermined condition satisfied by ambient parameters with respect to first reference data. The first predetermined condition may be representative of a critical working condition, that is, a working condition of the bio-containment system which requires the immediate intervention of a person, for example, a healthcare operator. For example, a first predetermined condition representative of a critical working condition (that is, a working condition of the bio-containment system which requires the immediate intervention of a person, for example, a healthcare operator) satisfied by one or more ambient parameters, may include one of the following first predetermined conditions: differential pressure parameter <10 Pa, air flow parameter <5m3/h, carbon dioxide parameter >1500 ppm, electric battery charge parameter <30%.

The method may include a step, performed by a control unit, of accessing a memory containing a first category for the alert indicator, this first category being defined as "critical". The method may include a step, performed by a control unit, of attributing an alert indicator to the "critical " category according to the first reference data, responsive to one of the first predetermined conditions satisfied by one or more ambient parameters with respect to the first reference data.

In an example embodiment, the method includes a step, performed by a control unit, of accessing a memory containing second reference data items and a third predetermined category for an alert indicator. The method may comprise a step, performed by a control unit, of processing parameters according to second reference data. The method may comprise a step, performed by a control unit, of attributing an alert indicator to a second or a third category, responsive to a second or a third predetermined condition satisfied by parameters with respect to second reference data.

In an example embodiment, the method includes a step, performed by a control unit, of accessing a memory containing second reference data for a plurality of ambient parameters, which may include, for example, a differential pressure parameter, a carbon dioxide parameter, an air flow parameter, an electric battery charge parameter, a temperature parameter, a humidity parameter and an electric battery voltage parameter. The method may include a step, performed by a control unit, of accessing a memory containing a second and a third predetermined category for an alert indicator. The method may comprise a step, performed by a control unit, of processing ambient parameters according to second reference data. The method may comprise a step, performed by a control unit, of attributing an alert indicator to a second category, responsive to a second predetermined condition satisfied by ambient parameters with respect to second reference data. The second predetermined condition may be representative of an abnormal working condition, that is, a working condition of the biocontainment system which requires the attention of a person, for example, a healthcare operator. For example, a second predetermined condition representative of an abnormal working condition (that is, a working condition of the bio-containment system which requires the attention of a person, for example, a healthcare operator) satisfied by one or more ambient parameters, may include one of the following second predetermined conditions: differential pressure parameter <40 Pa, air flow parameter <10m3/h, carbon dioxide parameter >1000 ppm, electric battery charge parameter <75%, temperature parameter <24°C or > 28°C, humidity parameter <40%RH or >80%RH, electric battery voltage parameter <10 or >15 V.

The method may comprise a step, performed by a control unit, of attributing the alert indicator to a third category, responsive to a third predetermined condition satisfied by ambient parameters with respect to second reference data.

The third predetermined condition may be representative of a normal working condition, that is, a working condition of the bio-containment system which does not require the attention of a person, for example, a healthcare operator.

For example, the third predetermined condition representative of a normal working condition (that is, a working condition of the bio-containment system which does not require the attention of a person, for example, a healthcare operator) satisfied by each of the ambient parameters, may include one of the following third predetermined conditions: differential pressure parameter >40 Pa, air flow parameter >10m3/h, carbon dioxide parameter <1000 ppm, electric battery charge parameter >75%, temperature parameter between 24°C and 28°C, humidity parameter between 40%RH and 80%RH, battery voltage parameter between 10 and 15 V.

The method may include a step, performed by a control unit, of accessing a memory containing a second category for an alert indicator, the second category being defined as "abnormal", and a third category for the alert indicator, the third category being defined as "normal". The method may include a step, performed by a control unit, of attributing an alert indicator to the "abnormal" category according to second reference data and responsive to a second predetermined condition satisfied by one or more ambient parameters with respect to second reference data.

The method may include a step, performed by a control unit, of attributing an alert indicator to the "normal" category according to second reference data and responsive to a third predetermined condition satisfied by one or more ambient parameters with respect to second reference data.

In an example embodiment, the method comprises a step, performed by a control unit, of accessing a memory containing a plurality of predetermined categories for a diagnostic indicator, the diagnostic indicator being representative of an undesirable working condition of the system; the method may comprise a step, performed by a control unit, of processing a diagnostic indicator. The method may include a step of attributing a diagnostic indicator to one or more predetermined categories of a plurality of predetermined categories. The method may include a step of attributing a diagnostic indicator to one or more predetermined categories of a plurality of predetermined categories, based on a plurality of parameters. For example, the method may comprise a step, performed by a control unit, of attributing a diagnostic indicator to one or more predetermined categories, based on a plurality of body parameters. For example, the method may comprise a step, performed by a control unit, of attributing a diagnostic indicator to one or more predetermined categories, based on a plurality of ambient parameters.

For example, the method may comprise a step of attributing a diagnostic indicator to one or more predetermined categories by means of a machine- learned model. In an example embodiment, the method comprises a step, performed by a control unit, of feeding a plurality of ambient parameters to a machine-learned model. The method may comprise a step, performed by a control unit, of training a machine-learned model. For example, the method may comprise a step, performed by a machine-learned model, of attributing a diagnostic indicator to predetermined categories. The method may comprise a step, performed by a machine-learned model, of selecting predetermined categories from those shown in the following list: low level of charge of an electric battery; break in wall system; shutdown of an electrical power unit; opening of a nozzle.

In an example embodiment, the method comprises a step, performed by a machine-learned model, of attributing a diagnostic indicator to predetermined categories through a classification algorithm. By "classification algorithm" is meant an algorithm that categorizes, that is to say, an algorithm that assigns an object to a predetermined category. For example, the method may comprise a step, performed by a classification algorithm, of assigning a diagnostic indicator to a predetermined category. By way of example, the method may include a step, performed by a classification algorithm, of attributing a diagnostic indicator including a plurality of classification trees. Each classification tree of the plurality of classification trees may include a plurality of nodes, where each node of the plurality of nodes represents a predetermined condition for a parameter; each classification tree may include a plurality of branches, where each branch represents a predetermined condition satisfied by a parameter. Each classification tree may include a plurality of terminations, where each termination represents a predetermined category. The method may comprise a step, performed by the classification algorithm, of attributing an object, for example, a diagnostic indicator, to the most frequent predetermined category of the predetermined categories of the plurality of classification trees.

In an example embodiment, the method comprises a step of creating an alerting system. The method may comprise a step, performed by a control unit, of deriving an alerting signal based on an alert indicator. The method may include a step, performed by a control unit, of deriving an alerting signal based on ambient parameters and/or on body parameters. The method may include a step, performed by a control unit, of deriving an alerting signal based on a diagnostic indicator. The method may comprise a step, performed by a control unit, of accessing an alerting system to send an alerting signal to the alerting system.

In an example embodiment, the method comprises a step, performed by a control unit, of accessing a database. The method may include a step, performed by a control unit, of storing ambient parameters and/or body parameters in a database. The method may include a step, performed by a control unit, of storing alert indicators in a database. The method may include a step, performed by a control unit, of storing diagnostic indicators in a database.

In an example embodiment, the method comprises a step, performed by a control unit, of accessing a screen. The method may include a step, performed by a control unit, of displaying ambient parameters and/or body parameters on a screen. The method may include a step, performed by a control unit, of displaying alert indicators on a screen. The method may include a step, performed by a control unit, of displaying diagnostic indicators on a screen.

In an example embodiment, the method comprises a step of providing a plurality of negative pressure chambers and a corresponding plurality of sensing systems.

For each negative pressure chamber, the method may comprise a step, performed by a control unit, of processing a respective plurality of parameters. For each negative pressure chamber, the method may comprise a step, performed by a control unit, of processing respective alert indicators from a plurality of parameters. For each negative pressure chamber, the method may comprise a step, performed by a control unit, of processing respective diagnostic indicators from a plurality of parameters. In particular, the method may comprise a step, performed by a control unit, of accessing a memory, the memory containing a plurality of predetermined categories for a diagnostic indicator, representative of an undesirable working condition for bio-containment and, for each negative pressure chamber, the method may comprise a step, performed by a control unit, of processing the respective plurality of ambient parameters and attributing the diagnostic indicator to one or more predetermined categories of the plurality of predetermined categories, based on the plurality of ambient parameters. The method may comprise a step, performed by a control unit, of generating image data to be displayed on a screen. The image data may be representative of a chart. The chart may illustrate a graphical indication of parameters of a plurality of negative pressure chambers. The chart may illustrate a graphical indication of alert indicators of a plurality of negative pressure chambers. The chart may illustrate a graphical indication of diagnostic indicators of a plurality of negative pressure chambers. The method may include a step, performed by a control unit, of generating a plurality of configurations for the image data representative of a chart.

For example, the method may include a step, performed by a control unit, of displaying a configuration of a plurality of configurations of a chart illustrating, in combination, alert indicators, parameters and diagnostic indicators for a plurality of negative pressure chambers. For example, the method may include a step, performed by a control unit, of displaying a configuration of a plurality of configurations of a chart illustrating, in combination, alert indicators, parameters and a diagnostic indicator for a negative pressure chamber.

For example, the method may include a step, performed by a control unit, of displaying a first configuration, where a chart may illustrate a graphical indication of diagnostic indicators and/or of one or more parameters of a plurality of parameters and/or of the diagnostic indicators of a plurality of negative pressure chambers.

For example, the method may include a step, performed by a control unit, of displaying a second configuration, where a chart may illustrate a graphical indication of a diagnostic indicator, of an alert indicator and of one or more parameters of a negative pressure chamber.

For example, the method may include a step, performed by a control unit, of displaying a third configuration, where a chart may illustrate a graphical indication of one or more ambient parameters of a negative pressure chamber, and one or more body parameters of a patient accommodated in a negative pressure chamber.

In an embodiment, the chart includes a plurality of configurations, where, in a first configuration, the chart illustrates a plurality of alert indicators, a plurality of diagnostic indicators and a plurality of ambient parameters of the respective plurality of negative pressure chambers, and in a second configuration, the chart illustrates an alert indicator, a diagnostic indicator and a plurality of ambient parameters of one negative pressure chamber of the plurality of negative pressure chambers. The method may comprise a step, performed by a control unit, of switching a chart between one configuration and another configuration of the plurality of configurations.

It should be noted that the bio-containment system of this disclosure may be applied in a hospital or in any structure intended to contain one or more containment chambers, for example, a vehicle; the vehicle may, for example, be a road vehicle (for example, an ambulance) or an aircraft (for example, an aeroplane or a helicopter).

It should be noted that this disclosure also covers a system and a method for monitoring one or more containment chambers.

Brief description of the drawings

These and other features will become more apparent from the following description of a preferred embodiment, illustrated by way of non-limiting example in the accompanying drawings, in which:

Figure 1 illustrates a bio-containment system comprising a plurality of negative pressure chambers.

Figure 2 illustrates a bio-containment system (1 ) for a patient.

Figure 3 shows a flow chart for deriving an alert indicator.

Figure 4 shows a flow chart for deriving a diagnostic indicator.

Figures 5a, 5b and 5c show, respectively, a first, a second and a third example configuration of a chart to be displayed on a screen.

Detailed description of preferred embodiments of the invention

The numeral 1 in the drawings denotes a system for bio-containment of a patient.

In an embodiment, the bio-containment system 1 comprises a plurality of negative pressure chambers 10. The negative pressure chamber 10 of the plurality of negative pressure chambers may be configured to accommodate a patient.

The negative pressure chamber 10 includes a wall system 101 that defines an internal space 109. The wall system 101 includes an enclosure movable between an open configuration and a closed configuration. The open configuration, for example, allows the patient to be accommodated inside the chamber 10. The closed configuration, for example, allows creating, inside the internal space 109, an environment that is isolated from the outside environment.

The wall system 101 includes an air inlet 102. The air inlet 102 is configured to allow air from the outside environment to be taken into the internal space 109 of the chamber 10.

The negative pressure chamber 10 includes an air outlet 103. The air outlet 103 is configured to allow the air to be expelled from the internal space 109 to the outside environment.

The wall system 101 includes a pressure regulating system 104 configured for generating and holding a negative pressure inside the internal space 109; the pressure regulating system 104 is configured for expelling air into the outside environment through the air outlet 103. The pressure regulating system has a pump 105. The pump is connected to the airt outlet 103 and is configured to extract air from the internal space 109 and to expel it into the outside environment through the air outlet 103. The pressure regulating system 104 has an electrical power unit 106. The electrical power unit 106 is connected to the pump 105 to drive it.

The negative pressure chamber 10 includes a filter 107, connected to the air outlet 103 and configured to filter the air expelled into the outside environment through the air outlet 103 by the pump 105.

The system 1 for bio-containment of a patient comprises an electric battery 70.

The system 1 for bio-containment of a patient comprises a plurality of sensing systems 20. The sensing system of the plurality of sensing systems 20 is configured to detect a plurality of signals. The system 1 for biocontainment of a patient comprises a plurality of electric batteries 70 for powering the corresponding plurality of sensing systems 20. The sensing system 20 includes a plurality of sensors. The plurality of sensors includes a plurality of ambient sensors 201 , configured to detect a corresponding plurality of ambient signals; the ambient signals are representative of an ambient condition inside the internal space 109.

The ambient sensors of the plurality of ambient sensors 201 are selected from the following list: a differential pressure sensor, to detect a differential pressure parameter, the differential pressure parameter being defined as a difference between the pressure inside the internal space 109 and the pressure outside the internal space; a temperature sensor, to detect a temperature parameter, the temperature parameter being defined as a temperature of the air inside the internal space 109; a carbon dioxide sensor, to detect a carbon dioxide parameter, the carbon dioxide parameter being defined as an amount of carbon dioxide in the air inside the internal space 109; a humidity sensor, to detect a humidity parameter, the humidity parameter being defined as a humidity of the air inside the internal space 109; an electric battery 70 charge sensor to detect a charge parameter of the electric battery 70, the charge parameter of the electric battery 70 being defined as a charge of the electric battery 70; an electric battery 70 voltage sensor, to detect a voltage parameter of the electric battery 70, the electric battery 70 voltage parameter being defined as a voltage at the electric battery 70.

The plurality of sensors includes a plurality of body sensors 203, configured to detect a corresponding plurality of body signals; the body signals are representative of a condition of a patient's body.

The body sensors of the plurality of body sensors 203 are selected from the following list: a blood pressure sensor, to detect a blood pressure parameter, the blood pressure parameter being defined as a patient's blood pressure; a body temperature sensor, to detect a body temperature parameter, the body temperature parameter being defined as a patient's body temperature; a blood oxygen saturation sensor, to detect an oxygen saturation parameter, the oxygen saturation parameter being defined as a level of oxygen saturation in a patient's blood; a heart rate sensor, to detect a heart rate parameter, the heart rate parameter being defined as a patient's heart rate.

The negative pressure chamber 10 includes a plurality of nozzles 108, configured for connecting one or more sensors of the plurality of sensors to the internal space 109 of the negative pressure chamber 10.

The bio-containment system 1 comprises a control unit 30.

The control unit 30 includes a memory 301 ; the control unit includes a processor 302. The control unit 30 is connected to the sensing system 20 for receiving the plurality of signals and deriving a plurality of parameters from the plurality of signals. In particular, the control unit 30 is connected to the sensing system 20 for receiving the plurality of ambient signals and the processor 302 is programmed for deriving a plurality of ambient parameters 303 from the plurality of ambient signals.

The plurality of ambient parameters 303 includes: the differential pressure parameter, the temperature parameter, the carbon dioxide parameter, the humidity parameter, the charge parameter of the electric battery 70 and the voltage parameter of the electric battery 70.

The control unit 30 is also connected to the sensing system 20 for receiving the plurality of body signals; the processor 302 is programmed for deriving a plurality of body parameters 304 from the plurality of body signals.

The plurality of body parameters 304 includes: the blood pressure parameter, the body temperature parameter, the blood oxygen saturation parameter and the heart rate parameter.

The processor 302 is programmed for deriving an alert indicator 305 for a person. The processor 302 processes the plurality of ambient parameters 303 to derive the alert indicator 305 for a person.

The memory 301 contains first and second reference data for the ambient parameters 303. The memory 301 contains a first predetermined category 306, a second predetermined category 307 and a third predetermined category 308 for the alert indicator 305. The processor 302 is programmed for processing the plurality of ambient parameters 303 and attributing the alert indicator 305 to the first category 306, the second category 310 or the third category 31 1 , responsive to a first condition 309, a second condition 310 or a third condition 31 1 satisfied by the plurality of ambient parameters 303.

In an example, the first predetermined condition 309 includes the following first predetermined conditions: differential pressure parameter <10 Pa, air flow parameter <5m3/h, carbon dioxide parameter >1500 ppm, charge parameter of the electric battery 70 <30%.

Responsive to the first predetermined conditions satisfied by at least one of the ambient parameters 303, the processor 302 is programmed for attributing the alert indicator 305 to the first category 306. The first category 306 is defined as "critical" and indicates a working condition of the biocontainment system 1 which requires the immediate intervention of a person.

In an example, the second predetermined condition 310 includes the following second predetermined conditions: differential pressure parameter <40 Pa, air flow parameter <10m3/h, carbon dioxide parameter >1000 ppm, battery charge parameter <75%, temperature parameter <24°C or > 28°C, humidity parameter <40%RH or >80%RH, battery voltage parameter <10 or >15 V.

Responsive to the second predetermined conditions satisfied by at least one of the ambient parameters 303, the processor 302 is programmed for attributing the alert indicator 305 to the second category 310. The second category 310 is defined as "abnormal" and indicates a working condition of the bio-containment system 1 which requires the attention of a person.

In an example, the third predetermined condition 31 1 includes the following third predetermined conditions: differential pressure parameter >40 Pa, air flow parameter >10m3/h, carbon dioxide parameter <1000 ppm, charge parameter of the electric battery 70 >75%, temperature parameter between 24°C and 28°C, humidity parameter between 40%RH and 80%RH, electric battery 70 voltage parameter between 10 and 15 V.

Responsive to each of the third predetermined conditions satisfied by each of the ambient parameters 303, the processor 302 is programmed for attributing the alert indicator 305 to the third category 308. The third category 308 is defined as "normal" and indicates a working condition which does not require the attention of a person.

The memory 301 contains a plurality of predetermined categories 313 for a diagnostic indicator 312, representative of an undesirable working condition for the system 1 ; by "undesirable working condition" of the system 1 is meant for example, a service disruption of the bio-containment system 1 .

The control unit 302 is programmed for attributing the diagnostic indicator 312 to one or more of the predetermined categories 313, based on the plurality of ambient parameters 303. The plurality of predetermined categories includes the following categories 313: charge parameter of the electric battery 70 low, break in enclosure; shutdown of the electrical power unit 106; one of nozzles 108 open.

The processor 302 attributes the diagnostic indicator 312 to one or more predetermined categories of the plurality of predetermined categories 313 through a machine-learned model 314. The processor 302 feeds the plurality of ambient parameters 303 to the machine-learned model 314. The machine-learned model 314 is trained to attribute the diagnostic indicator 312 to the predetermined categories 313.

The machine-learned model 314 is trained to attribute the diagnostic indicator 312 to the predetermined categories 313 through a classification algorithm. By "classification algorithm" is meant an algorithm that categorizes, that is to say, an algorithm that assigns an object, for example, a diagnostic indicator 312, to a predetermined category. In an example, the classification algorithm assigns the diagnostic indicator 312 to a predetermined category 313. By way of example, the classification algorithm comprises a plurality of classification trees 315. Each classification tree of the plurality of classification trees 315 includes a plurality of nodes 316, where each node of the plurality of nodes 316 represents a predetermined condition for an ambient parameter of the plurality of ambient parameters 303; each classification tree 316 includes a plurality of branches 317, where each branch of the plurality of branches 317 represents a predetermined condition satisfied by the ambient parameter of the plurality of ambient parameters 303. Each classification tree 315 includes a plurality of terminations 318, where each termination of the plurality of terminations 318 represents a predetermined category 313 for the diagnostic indicator 312. The classification algorithm assigns the diagnostic indicator 312 to the most frequent predetermined category 313 of the predetermined categories 313 of the plurality of classification trees 315.

The bio-containment system 1 comprises an alerting system 40. The control unit 30 is connected to the alerting system 40. The processor 302 is programmed for deriving an alerting signal, based on the alert indicator 305. The processor 302 is programmed for deriving an alerting signal, based on the ambient parameters 303. The processor 302 is programmed for deriving an alerting signal, based on the body parameters 304. The processor 302 is programmed for deriving an alerting signal, based on the diagnostic indicator 312. The processor 302 is programmed for sending the alerting signal to the alerting system 40.

The bio-containment system 1 comprises a database 50 for containing the ambient parameters 303, the body parameters 304, the alert indicator 305 and the diagnostic indicator 312. The control unit 30 is connected to the database 50. The processor 302 is programmed for storing the ambient parameters 303, the body parameters 304, the alert indicator 305 and the diagnostic indicator 312 in the database 50.

The bio-containment system 1 is connected to the screen 60. The control unit 30 is connected to the screen 60. The processor 30 is programmed for displaying the ambient parameters 303, the body parameters 304, the alert indicator 305 and the diagnostic indicator 312 on the screen 60.

The processor 302 is programmed for generating image data representative of a chart to be displayed on the screen 60.

The chart includes a plurality of configurations.

In an example embodiment, the chart, in a first configuration 601 , shows a graphical indication of the alert indicators 312 of the plurality of negative pressure chambers 10 and one or more ambient parameters 303 of the plurality of negative pressure chambers 10. In particular, in the first configuration 601 , the chart shows a graphical indication of the alert indicators 312, of the differential pressure parameter and of the air flow parameter of the plurality of negative pressure chambers 10. In a second configuration 602, the chart shows a graphical indication of the alert indicator 305, of the diagnostic indicator 312 and of one or more ambient parameters 303, including the differential pressure parameter, the air flow parameter, the carbon dioxide parameter, the temperature parameter, the humidity parameter, the electric battery 70 charge parameter, and the electric battery 70 voltage parameter, for one negative pressure chamber 10.

In a third configuration 603, the chart shows a graphical indication of one or more ambient parameters 303 of a negative pressure chamber 10, including the differential pressure parameter, the air flow parameter, the carbon dioxide parameter, the temperature parameter, the humidity parameter, the electric battery 70 charge parameter, and one or more body parameters 304 including, for example, the blood oxygen saturation parameter, the blood pressure parameter and the heart rate parameter for one negative pressure chamber 10 of a patient accommodated in that negative pressure chamber 10.

The processor 302 is programmed for displaying the plurality of configurations of the chart on the screen 60. The processor 302 is programmed for switching the chart between the first configuration 601 , the second configuration 602 and the third configuration 603.

This disclosure also provides a method for providing bio-containment.

In an embodiment, the method comprises a step of providing a plurality of negative pressure chambers 10. The negative pressure chamber of the plurality of negative pressure chambers 10 includes a wall system 101 that defines an internal space 109. The wall system includes an enclosure movable between an open configuration and a closed configuration.

The method comprises a step of generating a negative pressure inside the internal space 109. The method comprises a step of holding the negative pressure inside the internal space 109. The steps of generating and holding the negative pressure include a step of taking air in through an air inlet 102. The steps of generating and holding the negative pressure include a step of letting air out through an air outlet 103. The steps of generating and holding the negative pressure include a step of moving air, performed by a pressure regulating system 104, in particular by a pump 105 of the pressure regulating system 104. The method includes a step of driving the pump 105 by means of an electrical power unit 106.

The method includes a step of filtering air through a filter 107 before the air is expelled by the pump 105 into the outside environment through the air outlet 103.

The method comprises a step of providing an electric battery 70.

In an example, the method comprises a step of providing a plurality of sensing systems 20. The method comprises a step, performed by a plurality of batteries 70, of powering the corresponding plurality of sensing systems 20. The method includes a step of configuring the sensing system 20 and a step of providing a plurality of ambient sensors 201 to detect a corresponding plurality of ambient signals.

The method comprises a step of selecting one or more sensors of the plurality of ambient sensors 201 from those listed below: a differential pressure sensor, to detect a differential pressure parameter, the differential pressure parameter being defined as a difference between the pressure inside the internal space 109 and the pressure outside the internal space 109; a temperature sensor, to detect a temperature parameter, the temperature parameter being defined as a temperature of the air inside the internal space 109; a carbon dioxide sensor, to detect a carbon dioxide parameter, the carbon dioxide parameter being defined as an amount of carbon dioxide in the air inside the internal space 109; a humidity sensor, to detect a humidity parameter, the humidity parameter being defined as a humidity of the air inside the internal space 109; an electric battery 70 charge sensor to detect a charge parameter of the electric battery 70, the charge parameter of the electric battery 70 being defined as a charge of the electric battery 70; an electric battery 70 voltage sensor, to detect a voltage parameter of the electric battery 70, the electric battery 70 voltage parameter being defined as a voltage at the electric battery 70.

The method includes a step of providing a plurality of body sensors 203 to detect a corresponding plurality of body signals.

The method comprises a step of selecting one or more body sensors of the plurality of ambient body sensors 203 from those listed below: a blood pressure sensor, to detect a blood pressure parameter, the blood pressure parameter being defined as a patient's blood pressure; a body temperature sensor, to detect a body temperature parameter, the body temperature parameter being defined as a patient's body temperature; a blood oxygen saturation sensor, to detect an oxygen saturation parameter, the oxygen saturation parameter being defined as a level of oxygen saturation in a patient's blood; a heart rate sensor, to detect a heart rate parameter, the heart rate parameter being defined as a patient's heart rate.

The method comprises a step of connecting one or more sensors of the plurality of ambient sensors 201 and of the plurality of body sensors 203 to the negative pressure chamber 10 through one or more nozzles 108. the method comprises a step, performed by a control unit 30, of receiving the plurality of signals; the method comprises a step, performed by the processor 302, of deriving a plurality of ambient parameters 303 from the plurality of ambient signals.

The method comprises a step, performed by the control unit 30, of receiving the plurality of body signals; the method comprises a step, performed by the processor 302, of deriving a plurality of body parameters 304 from the plurality of body signals.

The method includes a step, performed by the processor 302, of deriving from the plurality of ambient parameters 303 an alert indicator 305 for a person, representative of a need for intervention on a bio-containment system 1 .

The method includes a step, performed by the processor 302, of accessing the memory 301 , containing first and second reference data for the ambient parameters 303 and a first predetermined category 306, a second predetermined category 307 and a third predetermined category 308 for the alert indicator 305. The method includes a step, performed by the processor 302, of processing the plurality of ambient parameters 303 and a step of attributing the alert indicator 305 to the first category 306, the second category 310 or the third category 31 1 , responsive to a first condition 309, a second condition 307 or a third condition 308 satisfied by the plurality of ambient parameters 303.

In an example, the first predetermined condition 309 includes the following first predetermined conditions: differential pressure parameter <10 Pa, air flow parameter <5m3/h, carbon dioxide parameter >1500 ppm, charge parameter of the electric battery 70 <30%. Responsive to the first predetermined conditions satisfied by at least one of the ambient parameters 303, the method includes a step of attributing the alert indicator 305 to the first category 306, which is defined as "critical" and indicates a working condition of the bio-containment system 1 which requires the immediate intervention of a person.

In an example, the second predetermined condition 310 includes the following second predetermined conditions: differential pressure parameter <40 Pa, air flow parameter <10m3/h, carbon dioxide parameter >1000 ppm, electric battery 70 charge parameter <75%, temperature parameter <24°C or > 28°C, humidity parameter <40%RH or >80%RH, electric battery 70 voltage parameter <10 or >15 V.

Responsive to the second predetermined conditions satisfied by at least one of the ambient parameters 303, the method includes a step of attributing the alert indicator 305 to the second category 307, which is defined as "abnormal" and indicates a working condition of the bio-containment system 1 which requires the attention of a person.

Responsive to the third predetermined conditions satisfied by each of the ambient parameters 303, the method includes a step of attributing the alert indicator 305 to the third category 308, which is defined as "normal" and indicates a working condition of the bio-containment system 1 which does not require the attention of a person.

The method comprises a step, performed by the processor 302, of accessing the memory 301 containing a plurality of predetermined categories 313 for a diagnostic indicator 312, the diagnostic indicator 312 being representative of an undesirable working condition of the system 1 , for example, a service disruption of the bio-containment system 1 .

The method includes a step of attributing the diagnostic indicator 312 to one or more of the predetermined categories of the plurality of predetermined categories 313, based on the plurality of ambient parameters 303.

The step of attributing the diagnostic indicator 312 is carried out through a machine-learned model 314. The method comprises a step, performed by the processor 302, of feeding the plurality of ambient parameters 303 to the machine-learned model 314. The method includes a step, performed by the processor 302, of training the machine-learned model 314. The method comprises a step, performed by the processor 302, of selecting one of the following categories for the diagnostic indicator 312: charge parameter of the electric battery 70 low, break in enclosure; shutdown of the electrical power unit 106; one of nozzles 108 open.

The method comprises a step, performed by a machine-learned model 314, of attributing the diagnostic indicator 312 to one of the predetermined categories 313 of the diagnostic indicator 312 through a classification algorithm. By "classification algorithm" is meant an algorithm that categorizes, that is to say, an algorithm that assigns an object, for example, a diagnostic indicator 312, to a predetermined category 313. The method comprises a step of assigning the diagnostic indicator 312 to one of the predetermined categories 313 through a classification algorithm. The method includes a step of attributing the diagnostic indicator 312 through a classification algorithm including a plurality of classification trees 315. Each classification tree of the plurality of classification trees 315 includes a plurality of nodes 316, where each node of the plurality of nodes 316 represents a predetermined condition for an ambient parameter of the plurality of ambient parameters 303; each classification tree 315 includes a plurality of branches 317, where each branch of the plurality of branches 317 represents a predetermined condition satisfied by the ambient parameter of the plurality of ambient parameters 303. Each classification tree 315 includes a plurality of terminations 318, where each termination of the plurality of terminations 318 represents a predetermined category 313 for the diagnostic indicator 312. The method comprises a step, performed by the classification algorithm, of attributing the diagnostic indicator 312 to the most frequent predetermined category 313 of the predetermined categories 313 of the plurality of classification trees 315.

The method comprises a step of creating an alerting system 40.

The method comprises a step, performed by the processor 302, of deriving an alerting signal based on the ambient parameters 303. The method comprises a step, performed by the processor 302, of deriving an alerting signal based on the body parameters 304. The method comprises a step, performed by the processor 302, of deriving an alerting signal based on the alert indicator 305. The method comprises a step, performed by the processor 302, of deriving an alerting signal based on the diagnostic indicator 312. The method comprises a step, performed by the processor 302, of accessing the alerting system 40 to send the alerting signal to the alerting system 40.

The method comprises a step, performed by the processor 302, of accessing a database 50. The method includes a step, performed by the processor 302, of storing the ambient parameters 303, the body parameters 304, the alert indicator 305 and the diagnostic indicator 312 in the database 50.

The method includes a step, performed by the processor 302, of accessing a screen 60. The method includes a step, performed by the processor 302, of displaying the ambient parameters 303, the body parameters 304, the alert indicator 305 and the diagnostic indicator 312.

The method comprises a step, performed by the processor 302, of generating image data representative of a chart to be displayed on the screen 60. The method comprises a step of generating a plurality of configurations for the image data.

In an example, the method includes a step, performed by the processor 302, of displaying a chart in a first configuration 601 , showing a graphical indication of the alert indicators 305 of the plurality of negative pressure chambers 10 and one or more ambient parameters 303 of the plurality of negative pressure chambers 10. In an example, the method includes a step of displaying a chart in the first configuration 601 , showing a graphical indication of the alert indicators 305, of the differential pressure parameter and of the air flow parameter of the plurality of negative pressure chambers 10.

In an example, the method comprises a step, performed by the processor 302, of displaying a chart in a second configuration 602, showing a graphical indication of the alert indicator 305, of the diagnostic indicator 312 and of one or more ambient parameters 303, including the differential pressure parameter, the air flow parameter, the carbon dioxide parameter, the temperature parameter, the humidity parameter, the electric battery 70 charge parameter, and the electric battery 70 voltage parameter, for one negative pressure chamber 10.

In an example, the method comprises a step, performed by the processor 302, of displaying a chart in a third configuration 603, showing a graphical indication of one or more ambient parameters 303, including the differential pressure parameter, the air flow parameter, the carbon dioxide parameter, and one or more body parameters 304, including the blood oxygen saturation parameter, the blood pressure parameter and the heart rate parameter, for one negative pressure chamber 10 and a patient accommodated in that negative pressure chamber 10. The method comprises a step, performed by the processor 302, of switching the image data between the first configuration 601 , the second configuration 602 and the third configuration 603.

Claims

43

1 . A system (1 ) for bio-containment of a patient, comprising: a negative pressure chamber (10), including: a wall system (101 ), defining an internal space (109) and provided with an air inlet (102) and an air outlet (103); a pressure regulating system (104), connected to the air outlet (103), to generate and hold a negative pressure inside the internal space (109); a sensing system (20), including a plurality of ambient sensors (201 ) configured to detect a corresponding plurality of ambient signals representative of an ambient condition inside the internal space (109); a control unit (30), including a memory (301 ) and a processor (302), connected to the sensing system (20) for receiving the plurality of ambient signals and programmed for deriving a plurality of ambient parameters (303), from the plurality of ambient signals, characterized in that the control unit (30) is also programmed for processing the plurality of ambient parameters (303), to derive an alert indicator (305) for a person, representative of a need for intervention on the biocontainment system (1 ).

2. The system (1 ) according to claim 1 , wherein the ambient sensors of the plurality of ambient sensors are selected from the following list: a differential pressure sensor, to detect a differential pressure parameter, the differential pressure parameter being defined as a difference between the pressure inside the internal space (109) and the pressure outside the internal space (109); a temperature sensor, to detect a temperature parameter, the temperature parameter being defined as a temperature of the air inside the internal space (109); a carbon dioxide sensor, to detect a carbon dioxide parameter, the carbon dioxide parameter being defined as an amount of carbon dioxide in 44 the air inside the internal space (109); an air flow sensor, to detect an air flow parameter, the air flow parameter being defined as an air flow in the internal space (109); a humidity sensor, to detect a humidity parameter, the humidity parameter being defined as a humidity of the air inside the internal space (109); an electric battery (70) charge sensor, to detect a charge parameter of an electric battery (70), the charge parameter of an electric battery (70) being defined as a charge level of an electric battery (70) included in the system (1 ); an electric battery (70) voltage sensor, to detect a voltage parameter of an electric battery (70), the voltage parameter of an electric battery (70) being defined as a voltage at an electric battery (70) included in the system (1 )-

3. The system (1 ) according to the claim 2, wherein: the sensing system (20) includes the differential pressure sensor, the carbon dioxide sensor, the air flow sensor and the battery (70) charge sensor, wherein the ambient parameters (303) include the differential pressure parameter, the carbon dioxide parameter, the air flow parameter and the battery (70) charge parameter; the memory contains first reference data and at least a first (306) and a second (307) predetermined category for the alert indicator (305); the processor (30) is programmed to process the ambient parameters (303), in dependence of the first reference data, for attributing the alert indicator (305) to the first category (306) responsive to a first predetermined condition (309) being verified by the ambient parameters (303) with respect to the first reference data.

4. The system (1 ) according to claim 3, wherein the sensing system (20) further includes the temperature sensor, the 45 humidity sensor and the battery (70) voltage sensor, wherein the ambient parameters (303) further include the temperature parameter, for the humidity parameter and for the battery (70) voltage parameter; the memory (301 ) contains second reference data and a third (308) predetermined category for the alert indicator (305); the processor (30) is programmed to further process the ambient parameters (303) according to the second reference data, for attributing the alert indicator (305) to the second (307) or third (308) category, responsive to a second (310) or a third predetermined condition (31 1 ) being verified by the ambient parameters (303) with respect to the second reference data.

5. The system (1 ) according to any of the previous claims, wherein: the memory (301 ) contains a plurality of predetermined categories (313) for a diagnostic indicator (312), representative of an undesirable working condition for the system (1 ); the control unit (30) is programmed for attributing the diagnostic indicator (312) to one or more of the predetermined categories (313), on the basis of the plurality of ambient parameters (303).

6. The system (1 ) according to claim 5, wherein the predetermined categories (313) for the diagnostic indicator (312) are selected from the following items: low level of charge of an electric battery (70) provided in the system (1 ); wall system (101 ) broken; shutdown of an electrical power unit (106) provided in the pressure regulating system (104); opening of a nozzle (108) provided in the negative pressure chamber (10) to connect the sensing system (20) to the internal space (109).

7. The system according to any of the previous claims, wherein: the sensing system (20) includes a plurality of body sensors (203), configured to detect a corresponding plurality of body signals representative of a condition of a patient's body; the control unit (30) is connected to the sensing system (20) for receiving the plurality of body signals and is programmed for deriving a plurality of body parameters (304), from the plurality of body signals; the control unit (30) is programmed for deriving the alert indicator (305) also according to the plurality of body parameters (304).

8. The system (1 ) according to claim 7, wherein the body sensors of the plurality of body sensors (203) are selected from the following list: a blood pressure sensor, to detect a blood pressure parameter, the blood pressure parameter being defined as a patient's blood pressure; a body temperature sensor, to detect a body temperature parameter, the body temperature parameter being defined as a patient's body temperature; a blood oxygen saturation sensor, to detect an oxygen saturation parameter, the oxygen saturation parameter being defined as a level of oxygen saturation in a patient's blood; a heart rate sensor, to detect a heart rate parameter, the heart rate parameter being defined as a patient's heart rate.

9. The system (1 ) according to any of the previous claims, comprising a plurality of negative pressure chambers (10) and a corresponding plurality of sensing systems (20), wherein the control unit (30) is connected to each sensing system of the plurality of sensing systems (20) and, for each negative pressure chamber of the plurality of negative pressure chambers (10), is programmed for processing the respective plurality of ambient parameters (303), to derive a respective alert indicator (305), the control unit (30) being further programmed for generating image data to be displayed on a screen (60), the image data being representative of a chart showing a graphic indication for the alert indicators (305) of the plurality of negative pressure chambers (10).

10. The system (1 ) according to claim 9, wherein the memory (301 ) contains a plurality of predetermined categories (313) for a diagnostic indicator (312), representative of an undesirable working condition of the system (1 ) and wherein, for each negative pressure chamber of the plurality of negative pressure chambers (10), the control unit (30) is also programmed for attributing the diagnostic indicator (312) to one or more predetermined categories of the plurality of predetermined categories (313), on the basis of the respective plurality of ambient parameters (303), the chart also showing a graphical indication for the diagnostic indicators (312) of the plurality of negative pressure chambers (10).

1 1. The system (1 ) according to claim 10, wherein the chart comprises a plurality of configurations, wherein: in a first configuration, the chart shows a plurality of alert indicators, a plurality of diagnostic indicators and a plurality of ambient parameters of the respective plurality of negative pressure chambers; in a second configuration, the chart shows an alert indicator, a diagnostic indicator and a plurality of ambient parameters for a negative pressure chamber of the plurality of negative pressure chambers, the control unit being configured to switch the chart from the first configuration to the second configuration and vice versa.

12. A method for providing bio-containment of a patient, comprising the following steps: providing a negative pressure chamber (10) having an internal space (109); generating and holding a negative pressure inside the internal space (109); 48 providing a sensing system (20) including a plurality of ambient sensors (201 ); detecting, through the plurality of ambient sensors (201 ), a corresponding plurality of ambient signals representative of an ambient condition inside the internal space (109); receiving at a control unit (30) the plurality of ambient signals; through the control unit (30), deriving a plurality of ambient parameters (303) from the plurality of ambient signals; through the control unit (30), processing the plurality of ambient parameters (303) and deriving an alert indicator (305) for a person, representative of a need for intervention on the bio-containment.

13. The method according to claim 12, wherein the sensing system (20) includes: a differential pressure sensor, to detect a differential pressure parameter, the differential pressure parameter being defined as a difference between the pressure inside the internal space (109) and the pressure outside the internal space (109); a carbon dioxide sensor, to detect a carbon dioxide parameter, the carbon dioxide parameter being defined as an amount of carbon dioxide in the air inside the internal space (109); an air flow sensor, to detect an air flow parameter, the air flow parameter being defined as an air flow in the internal space (109); an electric battery (70) charge sensor to detect a charge parameter of an electric battery (70), the charge parameter of an electric battery (70) being defined as a charge of an electric battery (70); wherein the ambient parameters (303) include the differential pressure parameter, the carbon dioxide parameter, the air flow parameter and the electric battery (70) charge parameter; the method further comprising the following steps carried out by the control unit (30): 49 accessing a memory (301 ) containing first reference data and at least a first (306) and a second (307) predetermined category for the alert indicator (305); processing the ambient parameters (303) according to the first reference data, to attribute the alert indicator (305) to the first category

(306), responsive to a first predetermined condition (309) being verified by the ambient parameters (303) with respect to the first reference data.

14. The method according to claim 13, wherein the sensing system (20) further includes: a temperature sensor, to detect a temperature parameter, the temperature parameter being defined as a temperature of the air inside the internal space (109); a humidity sensor, to detect a humidity parameter, the humidity parameter being defined as a humidity of the air inside the internal space (109); an electric battery (70) voltage sensor, to detect a voltage parameter of an electric battery (70), the electric battery (70) voltage parameter being defined as a voltage at an electric battery (70); and wherein the ambient parameters (303) include the temperature parameter, the humidity parameter and the electric battery (70) voltage parameter; the method further comprising the following steps carried out by the control unit (30): accessing the memory (301 ), the memory including second reference data and a third (308) predetermined category for the alert indicator (305); processing the ambient parameters (305), also according to the second reference data, to attribute the alert indicator (305) to the second

(307) or third (308) category, responsive to a second (310) or a third predetermined condition (31 1 ) being verified by the ambient parameters 50

(303) with respect to the second reference data.

15. The method according to any of the claims from 12 to 14, comprising the following steps carried out by the control unit (30): accessing a memory (301 ), the memory (301 ) containing a plurality of predetermined categories (313) for a diagnostic indicator (312), representative of an undesirable working condition for bio-containment; processing the plurality of ambient parameters (303) and attributing the diagnostic indicator (312) to one or more of the predetermined categories (313), on the basis of the plurality of ambient parameters (303).

16. The method according to claim 15, wherein the control unit (30) feeds the plurality of ambient parameters (303) to a machine-learned model (314), the machine-learned model (314) being trained to attribute the diagnostic indicator (312) to the predetermined categories (313), the categories (313) being selected from the following list: low level of charge of an electric battery (70); break in a wall system (101 ) included in the negative pressure chamber (10); shutdown of an electrical power unit (106) of a pressure regulating system (104) provided for generating and holding the negative pressure inside the internal space (109); opening of a nozzle (108) provided in the negative pressure chamber (10) to connect the sensing system (20) to the internal space (109).

17. The method according to any of the claims from 12 to 16, comprising the following steps: providing a plurality of negative pressure chambers (10) and a corresponding plurality of sensing systems (20); through the control unit (30), processing the respective plurality of ambient parameters (303) for each negative pressure chamber (10), to 51 derive a respective alert indicator (305); through the control unit (30), generating image data representative of a chart showing a graphic indication for the alert indicators (305) of the plurality of negative pressure chambers (10); displaying the image data.

18. The method according to claim 17, comprising the following steps, carried out by the control unit (30): accessing a memory (301 ), the memory (301 ) containing a plurality of predetermined categories (313) for a diagnostic indicator (312), representative of an undesirable working condition for bio-containment; for each negative pressure chamber, processing the respective plurality of ambient parameters (303) and attributing the diagnostic indicator (312) to one or more of the predetermined categories (313), on the basis of the plurality of ambient parameters (303), the chart also showing a graphical indication for the diagnostic indicators (312) of the plurality of negative pressure chambers (10).

19. The method according to claim 18, wherein the chart includes a plurality of configurations, wherein: in a first configuration, the chart shows a plurality of alert indicators, a plurality of diagnostic indicators and a plurality of ambient parameters of the respective plurality of negative pressure chambers; in a second configuration, the chart shows an alert indicator, a diagnostic indicator and a plurality of ambient parameters for a negative pressure chamber of the plurality of negative pressure chambers, the method comprising a step, performed by the control unit, of switching the chart from the first configuration to the second configuration and vice versa.