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1. (WO2019026024) INTERACTIVE SYSTEM FOR HEALTHCARE APPLICATIONS
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DESCRIPTION

INTERACTIVE SYSTEM FOR MEDICAL APPLICATIONS

Technical field

This invention relates to an interactive system for medical applications and in particular to an integrated interactive system for digestive endoscopy, to which explicit reference is hereinafter made.

The interactive system, as explained in more detail below, is designed for a patient for allowing him/her to interact with the surrounding environment, with the medical apparatus controlled by the doctor and, therefore, with the doctor, aimed at reducing the stress and the constant monitoring of his/her subjective status during medical operations, in particular endoscopies, or in any case in those cases in which a general anaesthesia is not necessary.

Background art

Preferred sectors of application of this solution are endoscopic rooms or so-called "day surgeries" or dentistry rooms.

Endoscopic operations are usually performed in a medical room or the like in which the patient, once prepared, passively undergoes the operations necessary for performance of the examinations or of the investigations to which he/she must be subjected.

The increasing understanding, in a medical context, of the skills of personnel working in the sector even by of patients, for example thanks to the information available online, is resulting in an ever greater desire for a more significant involvement in the management of the relative medical care by patients-consumers.

Moreover, the daily multimedia interactivity in numerous aspects of life has lead to a growth in the marked propensity for interaction with the machines and the environment which surround us as well as the desire to offer per- sonal assessments on the activities which are undertaken and these ambitions are currently substantially neglected in the medical sector.

Currently, in fact, many medial practices, for example endoscopy or dentistry procedures, are carried out with an intervention on the patient by the doctor using medical apparatuses (for example, endoscopes, dental drill units, etc.). Some medical practices may be invasive and cause nervousness, discomfort and/or pain and are conventionally performed by using pharmacological sedoanalgesia, that is to say, premedication with drugs both to reduce anxiety and for analgesia.

At the same time, it may not be easy for the operator to monitor the subjective perception of discomfort or pain during the procedure, for example due to a lack of technological structures for this purpose and/or because the patient may have difficultly in communicating his/her subjective status of wellbeing or ill health. An understanding of the subjective mental-physical status of the patient as well as his/her state of consciousness would advantageously facilitate a possible variation of the activities of the doctor/medical operator during the procedure, for example by means of an alarm communicated to the doctor/medical operator, and would put them in a condition to work with greater safety and facilitate an improved quality perceived by the patient.

In this context, the main aim of the invention is to provide an integrated system for medical applications which are able to satisfy the above-mentioned requirements.

Aim of the invention

An aim of this invention is to provide an interactive system connected to and integrated with a medical apparatus which allows the patient to be active during medical operations to which he/she is subjected such as, for example, during an endoscopic examination and to relate with the medical environment, with the medical apparatus and with the medical personnel.

Another aim of this invention is to provide an interactive system which allows the patient to personalise, at least partly, the medical environment in which the process to which he/she is subjected is carried out.

Multimedia methods have currently been proposed such as alternative methods to pharmacological sedation. Documents such as Khadra et al.: "Projector-based virtual reality dome environment for procedural pain and anxiety in young children with burn injuries: a pilot study, Journal of Pain Research 2018:1 1 , pp. 343-353 e Pandya et al.: " Virtual reality distraction decreases routine intravenous sedation and procedure-related pain during preoperative adductor canal catheter insertion: a retrospective study, Korean Journal of Anesthesiology 2017, VOL. 70, NO. 4, August 2017, pp. 439-445 may be examples of these methods.

However, an absence of multimedia content has been noted for the purpose of involvement and reduction of the stress of the patient, for a direct interaction between the patient and the medical apparatus used by the doctor to perform the operation. For example, the use of such a method in the endoscopic sector, for example digestive or urological, or in the dental treatment sector, has not been noted.

The use of these methods could advantageously facilitate a reduction of the pharmacological dosage for sedation and preferably of the risks linked to the procedure in terms of pharmacological complications. Thanks to these techniques, it is possible to improve the outcome of the operation from the point of view of the patient and facilitate a faster discharging of the patient after the operation, as well as the possibility for the patient to indicate his/her subjective state of wellbeing or ill health through a full interactivity. Moreover, the signalling of the relative subjective status, interacting with the medical apparatus used by an operator, may indicate the fact that a certain operation in the procedure in progress can determine complications. In this way, this signalling may be useful for alerting the operator during the operation, in such a way as to interrupt of modify it when appropriate.

Moreover, the interactivity may allow an assessment of the state of consciousness. In effect, over the years, there has been an increase in sedo-analgesia procedures, which, however, should be accompanied with research on the cognitive and residual motor effects during the examination and post-procedural recovery phase. An excess pharmacological dosage in the absence of cognitive feedback by the patient may represent, in effect, a risk, in some cases even high, of procedural complications. Conventionally, during the procedure, the medical apparatuses are not provided with elements for feeding back the status perceived by the patient nor the state of consciousness. As mentioned above, the lack of an integrated system comprising cognitive monitoring and control of the perceived status of the patient during the examination of the anaesthetic sedation may represent a risk element.

There are currently biophysical monitors based on saccadic eye movements; see, for example Khan O.A. et al.: "Anaesthesia and saccadic eye movements", Anaesthesia 55(9):877-82 October 2000. Moreover, the documents US2010286490A1 , US2016042123A1 , US201801 1971 A1 , US2012/0310665A1 and TW201801677A may be interest for this invention.

Again, there does not currently appear to exist an integrated system between the patient, operating medical apparatus and doctor, in a medical room designed for medical procedures which can meet one or more of the following requirements:

- offering to the patient the possibility of actively participating in the examination procedure by means of an interactive system which is able to personalise the relative perceptive "environment", thanks to a vast choice of multimedia menus of environments designed to modify virtually the medical room in which the procedure is performed, for example by using virtual reality visors, in which the interactive system may be integrated with medical apparatus in such a way that one of the elements of choice can comprise displaying the procedure performed by the doctor; and/or

- preferably at the same time, creating an interaction between patient, medical apparatus, doctor and objective monitoring and reporting system (for example sensors applied to the patient and a memory unit which records the data measured by the sensors and/or the data relative to the procedure in progress), such as to guarantee to the patient the possibility of signalling, before, during (all) the procedure and in the post-procedural phase, alterations of the subjective status of the patient which can be received by the apparatus medical which in turn can signal, by means of alarms, a problematic situation for the patient; and/or

- allowing the objective interaction with the activity of the patient during the process (conventionally, the patient remains passive); which can be expressed and recorded by means of the multimedia choices made by the patient; and/or

- integrating the subjective signals with objective parameters, measurable independently by suitable measuring devices (for example, pulse monitors), conventionally not integrated in a recording of the entire period of the duration of the examination; and/or

- signalling, by means of the medical apparatus, alarm conditions (which can be pre-defined by the doctor), for example by sounds or vibrations; and/or

- recording and printing a trace relative to the procedure.

The prior art medical apparatuses designed for the procedures (for example, endoscopy systems, dentistry) do not appear to be designed for interacting with the patient. For example, the prior art apparatuses are not structured or connected with instruments or systems which can be directly controlled by the patient to allow a two-way communication between the patient and the operator.

The feeling of control and the possibility of modifying the environment by the patient can represent a parameter which improves the quality per-

ceived by the patient through the personalising of the environment and, therefore, the personalising of the procedure.

For example, the term 'modification of the environment' means the modification of real perceptive parameters (environmental colours, sounds, projections) or modification of a virtual environment through the use by the patient of special systems designed for immersive virtual reality applications.

For example, this invention may be applied in the case of sedoanalgesia of the conscious type (where the patient maintains the state of consciousness), where active involvement, personalising of the environment and the use of multimedia solutions, including in augmented and virtual reality, can reduce the impact of the procedure on the patient, for example a system is desirable which allows direct connection of the patient and a medical apparatus used by the doctor on the patient.

Moreover, it is desirable that, during the procedures, it is possible to control, for example by instruments independent from the medical apparatus in use, objective parameters of the patient, such as frequency, blood pressure, oxygen saturation as well as subjective parameters of the patient. These independent instruments may be connected to the medical apparatus in use, for example to exchange information relating to the status of the patient and/or the procedure in progress.

An interactive system is therefore desirable comprising the use of multimedia and immersive reality systems as an element for distraction and stress reduction and comprising a coupling of such a multimedia system with a medical apparatus used by a doctor. For example, the connection may be made to in order to form a complementary element to the sedoanalgesia action, not only by the interaction of the patient, with his/her active involvement, but also the transmission of multimedia elements with a distracting and therefore anxiolytic function, to be associated with pharmacological sedoanalgesia, which may facilitate a lowering, even tangible, of the pharmacological dosage.

Advantageously, the recoding of the pharmacological and of the simultaneous multimedia content together with the objective and subjective data of the status of the patient can contribute to an analysis of the activities carried out in order to reformulate, for example, the sedoanalgesia. An apparatus is also desirable which, during use, can be combined to a dynamic interface with the patient, which can send dynamically, for example whilst providing multimedia content sent by a multimedia system connected to the machine, data on his/her subjective status of wellbeing or ill health. These elements, transmitted in real time to the medical apparatus used by the doctor, can immediately modify the activities of the doctor. Moreover, these elements can be recorded and may therefore represent a tracking of the quality of the procedure performed.

In one embodiment, the system according to the invention is configured for connecting the doctor to the patient in a two-way fashion thanks to a multimedia and dynamic monitoring interface connected to the medical apparatus to be used by the doctor on the patient in a medical room.

The technical purpose indicated and the aims specified are substantially achieved by an interactive system for medical applications according to one or more of the appended claims.

According to an aspect of the invention, the invention relates to an interactive system for medical applications which allows an active interaction of a patient with an electro-medical apparatus in a medical room, such as, for example, a medical room or an endoscopic room.

The system in accordance with an aspect of the invention comprises a portable electronic device, for example a smartphone or a tablet, to which reference is hereinafter made without thereby limiting the scope of the invention, in communication with the electro-medical apparatus and which can be used by the patient.

According to an aspect of the invention, the invention relates to an integral covering system of the portable electronic device, used in the interactive system for medical applications, allows, amongst other things, the use of the electronic device in the medical room without adversely affecting the sterilising requirements.

According to an aspect of the invention, the interactive system comprises a multimedia system in communication with the portable electronic device and operating in the medical environment in which the interactive system operates.

According to an aspect of the invention, the portable electronic device is configured to interact with electro-medical apparatus with the multimedia system.

In a preferred embodiment, the electronic device is programmed with a so-called mobile phone application or, in general, an 'app' for interacting with the outside environment, for example with the medical room and/or with the operators in the room.

According to an aspect of the invention, the interactive system comprises a screen configured to display a condition of the patient, for example a condition of wellbeing or ill health, following a first instruction of the portable electronic device to the multimedia system.

According to an aspect of the invention, the portable electronic device is configured to send the first instruction on the basis of a first command of the patient.

According to an aspect of the invention, the portable electronic device is configured, preferably by the mobile phone application, to have at least a graphical interface in such a way that the patient can provide the first command.

According to an aspect of the invention, the multimedia system comprises a printer configured for printing a report on the condition of the patient, for example as displayed on the above-mentioned monitor if present, following a second instruction of the portable electronic device.

According to an aspect of the invention, the portable electronic device is configured to send the second instruction to the multimedia system on the basis of a second command of the patient.

According to an aspect of the invention, the portable electronic device is configured, preferably by the mobile phone application, to have at least a graphical interface in such a way that the patient can provide the second command.

According to an aspect of the invention, the multimedia system comprises a system for displaying images configured for displaying at least one environment in the medical room following a third instruction of the portable electronic device to the multimedia system.

According to an aspect of the invention, the portable electronic device is configured to send the third instruction to the multimedia system on the basis of a third command of the patient.

According to an aspect of the invention, the portable electronic device is configured, preferably by the mobile phone application, to have at least a graphical interface in such a way that the patient can provide the third command.

According to an aspect of the invention, in one embodiment, the display system comprises a projection screen positioned in the medical room and a projector for projecting on the projection screen the environment, in the form of images or videos, selected by the patient.

Advantageously, the screen is positioned in the medical room in such a way that it can be seen by the patient during the medical intervention.

In one embodiment, for example, the screen is in the form of a roller sheet which surrounds, at least partly, the operating table.

According to an aspect of the invention, the display system comprises a platform of the 'wearable' type which can be worn by the patient to show to the patient the environment selected.

According to an aspect of the invention, the portable electronic device is configured, preferably by the mobile phone application, to have at least a graphical interface in such a way that the patient can provide the third command.

According to an aspect of the invention, the multimedia system comprises an audio system for the diffusion in the medical room of at least one musical track following a fourth instruction of the portable electronic device to the multimedia system.

According to an aspect of the invention, the portable electronic device is configured to send the fourth instruction to the multimedia system on the basis of a fourth command of the patient.

According to an aspect of the invention, the portable electronic device is configured, preferably by the mobile phone application, to have at least a graphical interface in such a way that the patient can provide the fourth command.

According to an aspect of the invention, the interactive system comprises a system for integral covering of the portable electronic device which allows the use of the electronic device in the medical room without adversely affecting the sterilisation requirements.

According to an aspect of the invention, the integral covering system comprises a first case for the portable electronic device made of material suitable for sterilisation in an autoclave.

The first case is, for example, a security case of the electronic device. According to an aspect of the invention, the integral covering system comprises a second single-use medical case for the portable electronic device. Preferably, if there is also the first case, the electronic device with the first case is inserted in the second case.

According to an aspect of the invention, the portable electronic device is configured to receive from the electro-medical apparatus information on the medical procedure in progress following a fifth instruction of the portable electronic device to the electro-medical apparatus.

According to an aspect of the invention, the portable electronic device is configured to send the fifth instruction on the basis of a fifth command of the patient.

According to an aspect of the invention, the portable electronic device is configured, preferably by the mobile phone application, to have at least a graphical interface in such a way that the patient can provide the fifth command.

According to an aspect of the invention, the interactive system may comprise the electro-medical apparatus.

The interactive system comprises, in one embodiment, a safe for housing the electronic device when it is not in use.

According to an aspect of the invention, the interactive system comprises a modular unit which integrates, for example in the form of a display, the display screen of the condition of the patient and/or the printer and/or the safe for the portable electronic device.

In a preferred embodiment, the modular unit is directly connected to the medical apparatus or is integrated in the same.

According to an aspect of the invention, the invention relates to a an endoscopic room comprising an interactive system according to one or more aspects of the invention and wherein electro-medical apparatus is an endoscope.

Advantageously, the solution in accordance with one or more aspects of the invention allows the involvement of the patient during the relative operations.

The patient may personalise the relative environment by means of audio, images, videos.

The patient may also interact with the medical staff, providing both a feedback on his/her sensations during the operation and a printed report.

The interaction with the patient is made in such a way that he/she enters in an environment which may controlled through a dedicated app and a dedicated medical room set up to modified, at least partly.

Amongst the other things, in particular, the patient may have control, at least partial, of the activities in progress and can provide a feedback on the perceived quality by means of registrations which can also be printed.

Brief description of the drawings

Further features and advantages of this invention are more apparent in the non-limiting description of a preferred but non-exclusive embodiment of an interactive system for medical applications, as illustrated in the accompanying drawings, in which:

Figure 1 illustrates a schematic block diagram of an endoscopy room according to the invention;

Figure 2 illustrates a schematic block diagram of a detail of an interactive system for medical applications according to the invention;

Figure 3 illustrates a schematic view of an example of a portable electronic device forming part of an interactive system for medical applications in accordance with the invention;

Figure 4 illustrates a schematic view of a second example of a portable electronic device forming part of an interactive system for medical applications in accordance with the invention;

Figure 5 illustrates a schematic block diagram of a component of an interactive system for medical applications according to the invention.

Detailed description of preferred embodiments of the invention

With reference to Figure 1 , the numeral 100 denotes an endoscopy room in accordance with the invention.

The medical room 100 is an example of medical room in which there is an electro-medical apparatus 101 which, in the embodiment illustrated, is an endoscope or a system of endoscopic instruments or an endoscopy column or system, comprising both dedicated instruments and a monitor for displaying the operations, of substantially known type and not described in detail and to which explicit reference will be made without limiting the scope of the invention.

An interactive system 1 for medical applications for allowing an interaction of a patient P with an electro-medical apparatus, in particular the apparatus 101 , is provided in the medical room 100.

The system 1 comprises a portable electronic device 2, for example a smartphone or a tablet, in communication with the electro-medical apparatus 101 and which can be used by the patient P.

As will be described in detail below, the system 1 comprises a mobile phone application, resident, at least partly, in the device 2, to allow the patient P to interact with other devices present in the medical room 100.

Generally speaking, the device 2, of substantially known type, preferably comprises a touchscreen and wireless type communication systems by means of which the patient P may preferably communicate with other devices, as explained in more detail below; for clarity of description, the accompanying drawings indicate physical connections between the electronic device and the other devices, however, the preferred communication method is of the wireless type.

The system 1 comprises an integral covering system 3 of the portable electronic device 2 to allow the use, in terms of sterilisation, in the medical room 100.

As illustrated in particular in Figure 2, in a preferred embodiment the system 3 comprises a first case 4 for the device 2.

The first case 4 is, for example, a security case, such as the Kensington K39309US Secure Back, and it is made of material suitable for sterilisation in an autoclave.

In general, the case 4 is made of material suitable for sterilisation in an autoclave according to known procedures.

Preferably, the system 3 comprises a second single-use medical case 5 for the device 2.

The case 5 is, for example, in the form of a foldable cover inside of which may be placed the device 2 together with the case 4 when in use in the system 1 , that is to say, when the device 1 is given to the patient P.

The system 1 comprises a multimedia system in communication with the portable electronic device 2 and operating in the room 100.

The multimedia system is preferably configured to allow the patient P to interact with the medical operators OP and the apparatus 101 in the operating 100.

The multimedia system is preferably configured to allow the patient P to interact with the medical room 100 in such a way as to modify the environment at least partly for making him/her more comfortable.

The device 2 is configured to interact with the multimedia system.

In a preferred embodiment, the multimedia system comprises a monitor or screen or display, that is, a display system, schematically represented by a corresponding block 6, configured for displaying, for example to a medical operator OP, a condition of the patient P following a first instruction 11 given by the device 2 to the multimedia system.

For simplicity, a single operator OP is indicated, but the term operator can also mean a team working in the medical room 100.

More specifically, the device 2 is configured, for example through the above-mentioned mobile phone application, for sending the first instruction 11 on the basis of a first command of the patient P given by the touchscreen of the device 2.

Preferably, the device 2 is configured, by the mobile phone application, to have at least a graphical interface 7, schematically illustrated in Figure 3, in such a way that the patient P can provide the first command.

The condition selected by the patient P may correspond to a condition of ill health or wellbeing including any intermediate sensations which can, for example, be selected by means of one or more icons 8 provided in the graphical interface 7 and displayed by the screen 6.

In a preferred embodiment, the multimedia system comprises a printer, schematically represented as a block 9, configured for printing a report of the condition of the patient P following a second instruction I2 of the device 2.

The device 2 is configured to send the second instruction 12 to the multimedia system, and in particular to the printer 9, on the basis of a second command of the patient P.

Preferably, the device 2 is configured, by the mobile phone application, in such a way that the graphical interface 7 presents and icon 10 through which the patient P can provide the second command.

As illustrated in Figure 1 , the multimedia system comprises a system 1 1 for displaying images configured for displaying at least one environment

200 in the medical room 100 following a third instruction I3 of the device 2 sent to the multimedia system, in particular to the system 1 1 .

More specifically, the device 2 is configured, for example through the above-mentioned mobile phone application, for sending the instruction I3 on the basis of a third command of the patient P given by the touchscreen of the device 2.

Preferably, the device 2 is configured, by the mobile phone application, to have at least a graphical interface 12, schematically illustrated in Figure 4, in such a way that the patient P can provide the third command by, for example, corresponding icons 13.

In the example illustrated in Figure 4, the interface 12 shows to the patient P previews of the environment 200 (for example, mountain or coastal views), which can be displayed by the system 1 1 , and corresponding icons 13.

On the basis of the selection of the patient P, the image corresponding to the command and the icon 13 is displayed by the system 1 1 .

In practice, the device 2 is therefore configured to send the third instruction I3 to the display system on the basis of a third command of the patient P.

Advantageously, the environments 200 may be in the form of static images or also videos.

In one embodiment, illustrated in Figure 1 , the system 1 1 comprises a projection screen 14 positioned in the operating rom 100 and a projector 15 for projecting, on the screen 14, the environment 200.

In one embodiment, not illustrated, the display system comprises a platform of the 'wearable' type which can be worn by the patient P to show the environment 200 to the patient P.

With reference to Figures 1 and 4, the device 2, in use, shows the patient P the preview of the environments 200 which can be viewed, which the patient may choose using the corresponding icon 13.

Once the environment 200 of interest is selected, the device 2 sends the instruction to the display system I3 which transfers it on the screen 14 or on the 'wearable' platform, for example glasses.

More generally speaking, the multimedia system and/or the device 2 may be integrated in a 'wearable' platform comprising, for example, also a joystick for the commands of the patient P.

As illustrated in Figure 1 , the multimedia system comprises an audio system, schematically illustrated with a block 16, for the diffusion in the medical room 100 of at least one musical track following a fourth instruction I4 of the device 2 to the multimedia system, in particular to the system 16. The portable electronic device 2 is configured to send the fourth instruction I4 on the basis of a fourth command of the patient P.

In a preferred embodiment, the patient P selects a musical track from a list and the device 2 reproduces it, sending to the system 16.

Preferably, the device 2 is configured, by the mobile phone application, to have at least a graphical interface 17, schematically illustrated in Figure 4, in such a way that the patient P can provide the fourth command by, for example, corresponding icons 13.

In the example illustrated in Figure 4, the interface 17 shows to the patient P tracks which can be displayed by the system 16, and corresponding icons 18.

On the basis of the selection of the patient P, the track corresponding to the command and the icon 18 is played by the system 16.

In practice, the device 2 is therefore configured to send the fourth instruction I4 to the audio system 16 on the basis of a fourth command of the patient P.

In a preferred embodiment, the device 2 is configured, preferably by the mobile phone application, with the apparatus 101 in such a way that the patient P can be a participant, for example, in the techniques which are being used, the dosage of drugs used, the time passed from the start the intervention which are details normally available in the apparatus 101 . In a preferred embodiment, the device 2 is configured to receive from the apparatus 101 information I on the medical procedure in progress following a fifth instruction I5 from the device 2 to the apparatus 101 .

In practice, the mobile phone application allows the patient P to interrogate, with the instruction I5, the apparatus 101 to receive, preferably on the touch screen of the device 2, the significant information I at least of some of the parameters available for the intervention in progress.

In a preferred embodiment, the apparatus 101 also interacts with other devices/apparatuses present in the medical room 100 for integrating, if necessary, for example, also the data measured by a detector of vital parameters inside (blood pressure, cardiac rate, oxygen saturation and breathing frequency) and making them available to the device 2.

These parameters are also made available, for example by means of the device 2, to the printer 9 to be shared and printed in the above-mentioned report relative to the conditions of the patient P.

These parameters are also made available, for example by the device 2, to the monitor 6 to be displayed by it.

Preferably, the device 2 is configured, by the mobile phone application, to have at least a graphical interface 19, schematically illustrated in Figure 3, in such a way that the patient P can interrogate the apparatus 101 by, for example, corresponding icons 20.

The device 2 is configured, for example by means of the mobile phone application, in order to show to the patient P the data requested and made available by the apparatus 101 .

Since the portable electronic device 2 may also comprise sensitive data stored inside it, the interactive system comprises a portable safe 21 , of known type and not described or illustrated in detail, made available in the medical room 100 in order to protect the device 2.

The safe 21 has, for example, finger print recognition or a combination lock, and serves to house the device 2 when it is not in use.

In a preferred embodiment, illustrated for example in Figure 5, the system

I comprises a modular unit 22 which integrates the safe 21 , the monitor 6 and the printer 9.

In a preferred embodiment, the unit 22 is directly connected to the medical apparatus 101 .

The monitor 6 in the unit 22 may be in the form of a display and show, as already mentioned, the condition of the patient P (in the sense, for example, of the condition of wellbeing or ill health) following the first instruction

II given by the device 2 following the command of the patient P, in such a way that the operator OP can have a subjective control on the condition of the patient P.

In one embodiment, as mentioned, the monitor 6 in the unit 22 can display vital parameters of the patient P.

In one embodiment, the monitor 6 or also another display may be used for displaying the intensity of the need of the patient to have assistance, indicated schematically as 'phase intensity'.

The phase intensity is preferably indicated to the operator OP by means of a corresponding command given, for example, by a touchscreen monitor of the apparatus 101 . In practice, the monitor 6 is used to display a need of the operator OP as a function of the status of the patient P.

In a preferred embodiment, the apparatus 101 integrates the unit 22 or its components, either fully or partly.

For example, in the preferred example wherein the apparatus is an endoscope or a system of endoscopic instruments or an endoscopy column or system, comprising both dedicated instruments and a monitor for displaying the operations, the column or the system integrate at least the monitor 6 and/or the printer 9 and/or the safe 21 .

In one embodiment, the unit 22 integrates, optionally, also the data measured by a detector of parameters vital such as, for example, blood pressure, cardiac frequency, oxygen saturation and breathing frequency which are made available to the device 2 and/or to the printer 9.

In a preferred embodiment, the mobile phone application loaded on the device 2 is also designed to facilitate the patient in breathing so that the patient breathes in a sufficient and regular manner, which thus facilitates the muscular relaxation and, in particular, makes the endoscopic examination easier. This occurs by means of a search for the breathing synchronisation of the patient P with a dedicated icon, not illustrated, shown in the device 2, illustrating lungs, which expand and contract according to an optimum rhythm.

In one embodiment, the icon dedicated for the use of the breathing is reactive at an altered breathing frequency, such as, for example, measured by a dedicated detector, in such a way as to dynamically control the behaviour of the patient P.

In one embodiment, the graphics interface 7, 12, 17, 19 of the device 2 may comprise commands which can be activated by the patient P which may allow a continuous interaction between patient P and a medical operator OP, for example a doctor, regardless of the treatment conditions (for example, decubitus, impossibility of using the language etc.).

An embodiment may refer to an interactive system 1 configured for reducing pharmacological sedation and for dynamically determining objective and subjective parameters of the patient P which can produce and adaptation of the actions of the medical operator OP during the medical procedure itself.

In one embodiment, as already discussed, the interactive system 1 comprises a dynamic system to interact with the electro-medical apparatus 101 and preferably with the outside environment, for example with the medical room and/or with the operators in the room. For example, the system 1 allows a multi-directional integrated connection between medical operator, patient and medical apparatus. Again for example, the interactive system 1 allows an exchange of data and multimedia content between operator-patient-medical apparatus both during a medical operation, during a preceding time interval and/or after the operation. This solution, as previously discussed, is designed to improve the safety, the perceived quality and the performance of the medical procedures.

In a similar manner to that described above, the interactive system 1 may therefore be based on an integration and on a multi-directional interaction which can be recorded and formalised, for example, by means of a specific report, between the doctor, the patient and the medical apparatus in a medical room where the system may comprise a recording of a dynamic trace of the quality perceived by the patient. For example, the recording may contain data entered by or relating to the patient, data relating to actions performed by the doctor by means of the medical apparatus as well as data relating to the multimedia content to which the patient P has access by means of the multimedia system, for example in order in time. In one embodiment, the tracking of the actions and/or of the commands carried out may be collected during an operation by means of a tracking with ID of the video and of the medical apparatus 101 ; moreover, the tracking may be recorded during an interval of time corresponding to the pre-procedure, procedure and post-procedure phases. Optionally, there is the possibility of validating a video comprising the tracking, for example by providing a consent by means of a voice recording. This tracking may have one or more advantages, for example, the possibility to determine the context of the patient P in the case of sudden appearance of pain and/or discomfort.

In one embodiment, the interactive system 1 may comprise an interactive interface 7, 12, 17, 19 for the patient which makes it possible to integrate multimedia elements with interactive measurements of the subjective status of the patient, with it being possible to call up the interactive measurements of the status of the patient, when desired, by the patient and superposed on multimedia content.

As shown in Figure 1 , the projection screen 14 may show, even simultaneously:

- the environments 200, in the form of static images or even videos, and/or

- static images and/or video relating to the procedure in progress, and/or

- in a reduced portion 140 of the projection screen 14, one or more strings 1 10a, 1 10b, 1 10c, 1 10d indicating subjective or objective parameters relative to the patient P, for example perceived pain, time since the start of the procedure, level of sedation, heart rate, breathing.

In a preferred embodiment, the system 1 comprises a memory unit, schematically represented as a block 23, in communication with the portable electronic device 2, for example a memory card inside the device 2 such as a SD card micro.

In other embodiments, the system 1 comprises a memory unit in communication with the portable electronic device 2 and outside of it, for example a storage device such as a hard disk or a memory inside the electromedical apparatus 101 .

The memory unit 23 is configured to store a data item representing at least one interaction between the patient P and the electro-medical apparatus 101 by means of the portable electronic device 2, for example a communication of pain perceived by the patient P.

In a preferred embodiment, the memory unit 23 is in communication with the electro-medical apparatus 101 .

The memory unit 23 is configured to store a data item received from the electro-medical apparatus, for example a vital parameter of the patient P.

The vital parameter may be measured, for example, by the apparatus itself or by an above-mentioned associated vital parameter detector, such as, for example, a biometric sensor, schematically represented as a block 24. For example, the data stored in the memory unit 23 may be included in the report described above printed by the printer 9.

In one embodiment, as already discussed, the portable electronic device 2 used by the patient P may be in communication with the electro-medical apparatus 101 (in turn in communication with the doctor). The device 2 may comprise a display unit (for example, a touchscreen) designed for providing information to the patient P, for example multimedia content, and for receiving from the electro-medical apparatus 101 information I on the medical procedure in progress, even simultaneously, for example following an instruction by the patient P from the portable electro-medical device 2 to the electronic apparatus 101 .

In one embodiment, in a similar manner to that described above, the device 2 may form part of a web service type infrastructure and be configured, by the mobile phone application, to have at least a graphical interface 7, 12, 17, 19 in such a way that the patient P can interrogate the apparatus 101 and/or interact with the integrated multimedia system 6, 9, 1 1 , 16. For example, the multimedia system may be integrated with a system for measuring the subjective status of the patient, with the multimedia system in communication with the portable electronic device 2 operating in the medical room 100.

In one embodiment, the interactive system 1 may allow an interaction and communication, preferably multidirectional, between the patient, the medical operator and the medical apparatus by means of the components of the system. The system 1 may comprise a medical apparatus 101 , an electronic device 2 equipped with a display which can be used by the patient P, a web infrastructure of the type referred to above to allow the interactions, and a display unit 6 to allow the interaction of the doctor with the medical apparatus 101 .

As illustrated, the system 1 comprises the medical apparatus 101 , however there is the possibility of introducing further medical apparatuses inside the interactive system, which can be placed in communication through the web infrastructure as described above. The use of a tablet as the portable electronic device 2 is to be considered as a non-limiting example of an embodiment. As already discussed above, the portable electronic device 2 may comprise a pair of glasses (for example, a virtual reality visor) for the displaying and the patient P can provide commands to the portable electronic device 2, for example, by a touch screen, by means of commands linked to eye movements, vocal commands, a joystick and/or virtual gloves. In embodiments where there is a virtual reality visor present, there is the possibility of integrating the portable electronic device 2 and the system 1 1 for displaying images.

In one embodiment, the system 1 may therefore allow a control of the objective and subjective status of the patient P through the medical apparatus 101 and the multimedia system 6, 9, 1 1 , 16.

As described above, the system 1 may also be of use for controlling the sedation of the patient P by means of the subjective and objective control of the patient P.

In one embodiment, the interactive system 1 may be configured for performing, automatically (for example, periodically) or on the request of a medical operator OP by means of a command on the electro-medical apparatus 101 , cognitive tests for assessing the state of consciousness of the patient.

In one embodiment, the interactive system 1 may allow the informed consent of the patient P to be obtained by mean of a multimedia display of the procedure and/or material presented in a preferred language. In this way, the patient P may be conscious of the actions which will be carried out by the medial operator OP during the procedure.

In one embodiment, the condition of the patient P communicated after a first instruction 11 may comprise an indication on a perceived discomfort or pain. Moreover, the objective control of the patient may comprise the measurement of vital parameters, by means of the vital parameters detection device 24, indicating a condition of stress of the body of the patient P, for example tachycardia or lack of response to one or more cognitive tests, usually correlated with a condition of pain.

For example, if the instruction 11 indicates presence of a pain greater than a first predetermined threshold and/or vital parameters indicating a condition of stress of the body of the patient P exceed a second predetermined threshold (for example, heart rate greater than a certain frequency or absence of response by the patient above a time limit), an alarm signal may be emitted, for example an audio or optical signal which can be perceived by the medical operator OP, optionally in addition to a display of the alarm on the display system 6.

Thanks to the embodiments discussed, it is possible to monitor dynamic variations in the wellbeing, pain and/or discomfort status of the patient P and an interactivity is also possible, formalised after one or more commands by the patient P.