Hyperbaric device for medical and therapeutic use

Abstract

A hyperbaric chamber, which consists of a pressurized environment designed to provide high-pressure oxygen to people inside therein, is here described, wherein said hyperbaric chamber is made through a filament-winding process. This type of chamber is used in various medical and therapeutic applications.

Description

[0001] HYPERBARIC DEVICE FOR MEDICAL AND THERAPEUTIC USE

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a hyperbaric chamber, which consists of a pressurized environment designed to provide high-pressure oxygen to people inside therein. This type of chamber is used in various medical and therapeutic applications.

[0004] BACKGROUND OF THE INVENTION

[0005] The hyperbaric chamber is an apparatus capable of withstanding the air pressure therein (higher than the atmospheric pressure, hence the term "hyperbaric") and which allow to house people who need to undergo a hyperbaric decompression treatment, for example, in the case of divers for non-observance of decompression, or need for hyperbaric therapy in patients suffering from various conditions. It owes its name to the fact that its invention is derived from the need to perform decompression stops by deep-sea divers. Subsequently, it has been given other names depending on its use: recompression chamber, hyperbaric therapy chamber, or hyperbaric chamber; the latter is the technical name of the apparatus, which is officially designated as such.

[0006] The hyperbaric chamber consists of a cylindrical enclosure generally made of metal, but also transparent acrylic material or fabric, and resistant to medium or high pressures depending on the typologies, closed by hermetic doors and connected to cylinders of breathable compressed air and oxygen and possibly other gas (helium), which is input to generate a pressure different from the atmospheric pressure and to allow breathing inside. The models used at the hyperbaric centres are capable of housing several people and have separate but connected environments to allow the passage of patients and / or medical personnel from inside to outside and vice versa, allowing environmental compensation. Therefore, they are large-sized, fixed stations with sophisticated management and monitoring equipment, comprising audio-video communication systems. In certain cases, a real operating room can be set up for delicate and particular interventions, and in cases it involves intervening on an embolized patient with traumas and injuries caused during a dive.

[0007] There are also portable single-seater or two-seater models that are accommodated on boats, vans, helicopters, and airplanes, some being directly equipped with a homologated towing system and thus towable by rescue vehicles and / or ambulances, which allow to recover embolized patients and their transport to the centre, and subsequently transfer them in the main hyperbaric chamber of the centre through connection flanges and subsequent pressure compensation. Flexible and portable decompression chamber models have also been constructed and are currently marketed, made with very-high-resistant non-breathable fabrics and closure with a waterproof zipper similar to those of special diving suits. Very useful for being transported anywhere, they are used to perform hyperbaric therapies at home and sometimes for exploratory dives in very vast and inaccessible karst environments. The latter have a very competitive price and are a very valid alternative solution, especially in case of emergencies where there are no hyperbaric centres or it is not possible to transport the patient.

[0008] Overview of hyperbaric therapy, how to breathe air and oxy yen

[0009] In a hyperbaric therapy session, the patient breathes both air and oxygen, but the oxygen is administered at a higher concentration than atmospheric air. The hyperbaric therapy involves immersing the patient in a specifically designed and sealed hyperbaric chamber, wherein the internal environment is maintained at a greater pressure than the external atmospheric pressure. During the hyperbaric therapy, the patient wears a mask, hood, or uses a sealed face mask to breathe the gas provided inside the chamber. This gas can be a mixture of pure oxygen and compressed air or enriched oxygen, depending on the specific therapy and patient needs. In some hyperbaric therapies, only pure oxygen (100% oxygen) is provided because the increased pressure increases the amount of oxygen dissolved in the blood and tissues, thereby promoting healing. In other situations, a mixture of oxygen and compressed air may be administered to reduce the risk of complications related to high-pressure oxygen. The increase in pressure inside the hyperbaric chamber characterizes the hyperbaric therapy and can be used to treat several medical conditions, such as decompression injuries for divers, chronic wounds that have difficulty in healing, carbon monoxide poisoning, and more. The high pressure helps to penetrate more oxygen into the body tissues, contributing to healing and recovery. In hyperbaric therapy, the air inside the hyperbaric chamber is compressed to increase the pressure thereof, but the composition of the atmosphere remains mainly air. During treatment, patients breathe this high- pressure air, which contains a greater amount of dissolved oxygen than the air at normal atmospheric pressure. Thus, the hyperbaric therapy does not rely on inhaling pure oxygen but on inhaling oxygen-enriched air.

[0010] The pressure inside the hyperbaric chamber can be increased to a level higher than atmospheric, usually measured in absolute atmospheres (ATA). For example, the pressure inside a hyperbaric chamber can be also raised to values greater than 2.0 ATA, which corresponds to about twice the normal atmospheric pressure at sea level (1.0 ATA). This increase in pressure facilitates the absorption of a greater amount of oxygen in body fluids, such as blood and tissues, accelerating the healing process in certain medical conditions.

[0011] During treatment, patients wear a face mask or an oxygen mask to breathe the pressurized air inside the chamber. Oxygen can be administered only to selected patients with specific medical prescriptions, but in most cases, the compressed air inside the chamber is sufficient to provide high levels of oxygen dissolved in the blood and tissues.

[0012] In summary, in hyperbaric therapy, patients breathe pressurized air with a higher amount of dissolved oxygen, while the internal environment of the chamber is at a higher pressure than the external environment. Pure oxygen is used only in particular cases, while compressed air plays a central role in treatment.

[0013] All devices and accessories for both operational and treating personnel are provided as elements accompanying the hyperbaric chamber (mask and hood and / or sealed face mask for breathing the gas provided) .

[0014] Hyperbaric chambers for providing high-pressure oxygen for medical and / or therapeutic use, the object of the present invention, are not described or suggested in the art.

[0015] DESCRIPTION OF THE FIGURES

[0016] The present invention will now be described, by way of illustration, but not limitation, with particular reference to the figures of the attached drawings.

[0017] Figure 1 shows, through an overview, the hyperbaric chamber of the present invention, installed inside a shelter made of composite material. The following components are thus present inside said shelter: an operator console (1) connected to a PLC (6); an electric panel (8); a hyperbaric chamber (7) comprising: o an inlet door (2); o a control porthole (3); o a pass-through window (4); o air, oxygen, and water pipelines (5); o oxygen and air cylinders (9), connected to the pipelines (5).

[0018] Figure 2 shows the hyperbaric chamber of the present invention, comprising:

[0019] • metal material and composite material elements (10) that form the inlet door (2);

[0020] • the metal supports (11) of the hyperbaric chamber (7).

[0021] The hyperbaric chamber (7) has the following dimensions: 1795 mm in width, 3527 mm in length, and 1850 mm in height (with the metal supports (11)) or 1600 mm in height (without the metal supports (11)).

[0022] Figure 3 schematically shows the filament-winding process used to construct the main structure of the hyperbaric chamber (7). In particular, the filament-winding process provides the use of:

[0023] • a spool of carbon fiber filament (12);

[0024] • a resin tank (13) useful for impregnating the carbon fiber filament (12);

[0025] • a nozzle (14) for exiting the carbon fiber filament previously impregnated with resin;

[0026] • a rotating mandrel (15), automatically controlled, necessary to wind the filament exiting the nozzle (14).

[0027] Said hyperbaric chamber (7) is thus made of composite material through said filament-winding procedure. DESCRIPTION OF THE INVENTION

[0028] The present invention relates to a hyperbaric chamber, which consists of a pressurized environment designed to provide high-pressure oxygen to people therein. This type of chamber is used in various medical and therapeutic applications.

[0029] The main technical features typical of the hyperbaric chamber object of the present invention are reported below.

[0030] • Pressure: the hyperbaric chamber can provide a pressure higher than atmospheric pressure, generally from 1.4 to 3 absolute atmospheres (ATA). The pressure inside the chamber, which will have a limited volume, can be regulated according to the treatment or specific application needs.

[0031] • Installation, dimensions, and capacity: the hyperbaric chamber will be housed inside a shelter (as shown in Figure 1). For hyperbaric treatment operations, the following personnel is provided to be accommodated inside the shelter / hyperbaric chamber assembly: up to two people being treated can be inside the hyperbaric chamber; 2 people (a doctor for controlling the patient's health status, and a technical operator responsible for managing the hyperbaric chamber in question, by means of a specific computer connected to an operator console with a graphical interface for operation management) can be inside the shelter.

[0032] • Chamber design: the hyperbaric chamber is designed to be safe and comfortable for patients. Said hyperbaric chamber further consists of advanced composite materials such as carbon and / or aramid fiber (Kevlar), with transparent windowing to allow the doctor to monitor patients during treatment. The use of this technology ensures the maximum lightness possible nowadays for a device of this type.

[0033] • Ambient pressure control system: the hyperbaric chamber is provided with a pressure control system that allows to increase or decrease the pressure inside the chamber. This is made through air and oxygen cylinders with a specific delivery and distribution system that provides high-pressure air to the chamber and oxygen for the patient. The pressure control system is capable of maintaining the desired pressure consistently and safely. For this purpose, an electronic control system, with redundant PLC (Programmable Logic Controller) architecture and latest-generation application software, is used.

[0034] • Oxygen delivery system: the hyperbaric chamber can deliver pure oxygen or a mixture of oxygen and other gases according to the treatment needs. Usually, oxygen is provided to patients through face masks, allowing them to breathe high-pressure oxygen during treatment.

[0035] • Auxiliary monitoring and safety systems: the hyperbaric chamber is provided with monitoring and safety subsystems to ensure the safety of patients during treatment.

[0036] Auxiliary subsystems and functions

[0037] The hyperbaric chamber of the present invention provides the following auxiliary subsystems and functions: an air compressor: provides compressed air inside the chamber to increase the pressure; a pressure control system: allows to regulate and maintain the pressure inside the chamber at the specifications required for patient treatment;

[0038] • an oxygen provision system: in some hyperbaric chambers, it can be necessary to provide pure oxygen to obtain higher oxygen levels compared to ambient air;

[0039] • an exhaust gas delivery system: to remove exhaled gas from patients and maintain a clean and safe environment inside the hyperbaric chamber;

[0040] • an audio and video communication system: used by external personnel to continuously monitor the patient's health status and communicate with him / her via audio and video during treatment so as to provide any necessary assistance.

[0041] • beds and / or seats for patients: the hyperbaric chamber can be configured, if necessary, with both seats and beds for patient comfort during treatment;

[0042] • a safety and emergency system: includes safety devices for emergency situations, such as the quick depressurization of the chamber.

[0043] Construction method of the hyperbaric chamber

[0044] The construction of the main structure of the hyperbaric chamber (7) is made of composite material by a filament-winding process. This is a complex but well- established operation normally used to create lightweight and strong tanks that contain dangerous liquids and / or gases. Filament-winding is a manufacturing technique that involves winding composite material fiber filaments (carbon, glass fiber, Kevlar®) around a mandrel to form the structure of the chamber. Subsequently, the structure is impregnated with a polymer resin, usually epoxy resin, which is hardened to create a solid and durable composite.

[0045] The essential steps of the filament-winding process (see Figure 3) are described below:

[0046] STEP 1 - designing: all the specifications of the hyperbaric chamber, comprising dimensions, capacity, maximum operating pressure, and structural requirements, are defined;

[0047] STEP 2 - selecting the materials: selecting the type of reinforcing fiber comprises carbon fiber, glass fiber, Kevlar®, etc., as well as the appropriate resin based on the needs of the hyperbaric chamber;

[0048] STEP 3 - preparing the mandrel (15): a solid or hollow mandrel with the internal shape of the hyperbaric chamber is made. The mandrel serves as the base, around which the fiber filaments (12) are wound;

[0049] STEP 4 - preparing the filaments: the fiber filaments (12) are immersed in the resin (13) to ensure good adhesion between the fiber and resin during winding;

[0050] STEP 5 - filament-winding: the fiber filaments (12) are wound around the mandrel (15) in a precise and controlled manner. The process is performed by specific machines that also allow manual intervention during operation;

[0051] STEP 6 - finishing layer: after the winding is completed, a resin finishing layer is added to improve the strength and surface finishing of the hyperbaric chamber;

[0052] STEP 7 - curing: the wound hyperbaric chamber is placed in a curing chamber where the resin is hardened through heat and other techniques, such as vacuum, depending on the type of process and resin used; STEP 8 - removing the mandrel: after the resin is completely hardened, the hyperbaric chamber can be removed from the mandrel;

[0053] STEP 9 - quality tests and controls: the finished hyperbaric chamber undergoes preliminary quality tests and controls to verify the strength, seal, and structural integrity thereof.

[0054] STEP 10 - finishing: the structure undergoes finishing operations such as smoothing and painting to meet the aesthetic and functional requirements;

[0055] STEP 11 - special treatments: in order to obtain the maximum safety in the use of the hyperbaric chamber, the composite components of said hyperbaric chamber, internally and externally, are subjected to a further treatment with a special paint, such as Carbocrylic 1290 ATEX. It is a finishing with antistatic and dissipative charges according to the regulations CEI EN 60079 (electrical constructions for explosive atmospheres due to the presence of gas) .

[0056] STEP 12 - further finishing: the hyperbaric chamber undergoes further finishing operations such as smoothing and painting to meet the aesthetic and functional requirements.

[0057] As mentioned, the main structure of the hyperbaric chamber is made of composite material. Since operational use is foreseen inside a shelter (see Figure

[0058] 1), which can be positioned in turn on the deck of mine-hunting ships, accordingly, said hyperbaric chamber is tested and certified according to the military standard

[0059] MIL-STD 810G (Environment Test Methods and Engineering Guidelines) for shock and vibrations in the naval field. The hyperbaric chamber of the present invention comprises several electronic components such as sensors, control subsystems (operator console, PLC, wireless communication systems, actuators, cameras, etc.); accordingly, said hyperbaric chamber is tested and certified free from susceptibility and / or radio frequency emissions according to the military standard MIL-STD 461G (Requirement for the Control of Electromagnetic Interference Characteristics of Subsystems and Equipment).

[0060] Materials used for the hyperbaric chamber

[0061] The main materials used for the construction of the hyperbaric chamber are the following:

[0062] • Composites: carbon fiber, glass fiber, aramid fiber (Kevlar®);

[0063] • Metals: steel, aluminium, and zinc;

[0064] • Special paints: Carbocrylic 1290 AT EX - finishing with antistatic and dissipative charges.

[0065] Main technical specifications of the hyperbaric chamber

[0066] The main technical specifications of the hyperbaric chamber are as follows:

[0067] • internal diameter from 1200 to 1300 mm;

[0068] • external diameter (max) 1795 - 1600;

[0069] • length 3527 mm;

[0070] • operating pressure up to 5 bar;

[0071] • design pressure 5*1.5 = 7.5 bar;

[0072] • must be certified as fire smoke in class 1;

[0073] • operating temperatures around 20°C (inside the shelter);

[0074] • weight of the chamber + all accessories (air and oxygen cylinders, pipelines, floor supports of the chamber, etc.) 1950 kg. The door of the hyperbaric chamber

[0075] The door of a hyperbaric chamber is designed with a high-seal elliptical shape factor to ensure the safety of patients and personnel using the chamber during treatment. The hyperbaric chamber is a sealed environment wherein the atmospheric pressure is increased above normal conditions in order to provide oxygen at higher concentrations for specific medical treatments.

[0076] The main aspects of the design of the door of the hyperbaric chamber are reported below:

[0077] • pressure-resistant materials: the door is made of robust and resistant carbon and / or glass fiber composite materials so as to withstand the high internal pressures of the hyperbaric chamber; for some accessories such as the portholes and pass-through window (i.e., for medications), alloys of aluminium, stainless steel, or other metal materials suitable for this purpose are used;

[0078] • gaskets and sealing systems: the gaskets are essential to ensure a hermetic seal of the door during the operation of the chamber; they are designed to prevent any pressure leaks from inside to outside and vice versa;

[0079] • controlled opening and closing: the door is designed so as to be opened and closed in a controlled and safe manner; there are blocking mechanisms or screw closures, which are used to ensure a hermetic seal and gradual opening;

[0080] • safety and emergency: the door is designed with an emergency system to allow the quick and safe exit of patients and personnel if necessary; quick release mechanisms or emergency opening systems are provided / included;

[0081] • accessibility: the door design allows an easy access for patients, minimizing the need for complex movements and manoeuvres.

[0082] • pressure tests: before use, the door and the entire hyperbaric chamber undergo rigorous pressure tests to ensure they meet safety and functionality requirements.

[0083] It should be noted that the specific design details can vary depending on the model of the hyperbaric chamber. In any case, the design, construction, and operation of the hyperbaric chamber comply with current regulations and specific guidelines to ensure the safety of patients and personnel.

[0084] Controlling the pressure in the hyperbaric chamber

[0085] Controlling the pressure in the hyperbaric chamber is a critical aspect to ensure a safe and controlled environment during treatment. The pressure control system regulates the pressure trend inside the chamber, ensuring that it remains constant or varies in a controlled manner according to the treatment needs / procedures. There are two main ways for controlling the pressure in a hyperbaric chamber: manual control exerted by an operator and automatic control by an operator with a command-and-control console.

[0086] Manual control: the hyperbaric chamber can be manually controlled, meaning that an operator or a specialized technician manually regulates the pressure inside the chamber. This can be done using gauges and pressure regulators. The experienced personnel will constantly monitor the pressure during treatment and make the necessary regulations to maintain the desired pressure. Automatic control: the hyperbaric chamber is provided with automatic pressure control systems. These systems are capable of continuously monitoring the pressure inside the chamber and regulating it automatically to maintain it constant or following pre-set programs. Automatic control is more precise and reliable, reducing the need for human intervention.

[0087] In both cases, the pressure control system is designed and constructed to maintain safe pressure levels complying with relevant guidelines and regulations. This means that the system can withstand the forces and stresses generated by the internal pressure of the hyperbaric chamber without risks of leaks or malfunctions.

[0088] It is important to note that during treatment in a hyperbaric chamber, the pressure may vary according to the treatment protocol and the patient's medical needs. The pressure can be gradually increased or decreased according to a specific scheme. The deceleration and acceleration of the pressurization process are managed so as to minimize the effects on the patient’s health and prevent quick decompression situations, which could result in health risks.

[0089] Finally, medical and technical personnel must be adequately trained to operate and monitor the pressure control system correctly and safely during treatment in the hyperbaric chamber.

[0090] Control of the ambient pressure via PLC (Programmable Logic Controller)

[0091] In the hyperbaric chamber, the control of the ambient pressure is carried out by means of an automatic regulation system based on PLC (Programmable Logic Controller), which monitors and regulates the internal pressure of the chamber to maintain it at the desired level. The pressure control via PLC is carried out through the use of the following components: • pressure sensors: the hyperbaric chamber is provided with pressure sensors that constantly measure the pressure inside the chamber; these sensors continuously send data to the PLC;

[0092] • pressure set-point: the PLC is programmed with a desired pressure value or "set-point", which represents the pressure, at which the environment inside the hyperbaric chamber is to be maintained;

[0093] • system control: the PLC processes the data from the pressure sensors and continuously compares the current pressure measure with the pre-set set-point;

[0094] • control actions: based on the difference between the current pressure and the set-point, the PLC decides on the corrective action to take to reach or maintain the desired pressure; depending on the specific system of the hyperbaric chamber, the PLC can control several devices to regulate the internal pressure;

[0095] • compressor: if the pressure is lower than the set-point, the PLC can activate the compressor to increase the pressure inside the chamber;

[0096] • exhaust valves: if the pressure is higher than the set-point, the PLC can open the exhaust valves to allow excess air to escape and reduce the pressure;

[0097] • inlet valves: the PLC can control the air inlet valves to regulate the amount of air entering the chamber, so as to reach the desired setpoint;

[0098] • control cycle: the PLC performs these control operations in a continuous and regular cycle to maintain the ambient pressure of the hyperbaric chamber as close as possible to the set-point; • monitoring and safety: throughout the control process, the PLC continuously monitors the operation of the system and verifies if there are any emergency situations or malfunctions. In case of faults or dangerous situations, the PLC can activate safety measures such as stopping the compressor or issuing alarms.

[0099] Software algorithm for controlling the pressure inside the hyperbaric chamber

[0100] The algorithm for controlling the pressure in a hyperbaric chamber is implemented both as a proportional (P) control or a PID (proportional-integral- derivative) control, depending on the precision and stability needs of the system.

[0101] P Control: in proportional control, the control action is proportional to the difference between the desired pressure set-point and the current pressure measure. This means that the greater the difference, the greater the corrective action to bring the pressure closer to the desired threshold. P control is the simplest of the three types of control and is often used in situations wherein small regulation errors can be tolerated. However, P control alone can lead to oscillations or a steady-state error (residual error between actual pressure and set-point) as it does not consider the past history of errors.

[0102] PID control: adds the integral and derivative components to the proportional control. In this way, the PID considers the past history of errors and their variations over time to provide a more precise and stable pressure control. The PID algorithm calculates the control action by combining three components:

[0103] • proportional (P): immediate action based on the current error;

[0104] • integral (I): action to reduce the steady- state error accumulated over time;

[0105] • derivative (D): action to anticipate and prevent quick pressure changes. PID control is very common in industrial control applications and is widely used in systems requiring a precise and fast control of the process variable.

[0106] The algorithm uses the values calculated by the PID controller to regulate the speed for pumping air in / out of the hyperbaric chamber. If the measured pressure is lower than the target pressure, the pumping speed will increase to increase the internal pressure. Vice versa, if the pressure is higher than the target pressure, it will reduce the pumping speed to decrease the pressure.

[0107] The PID control structure of the hyperbaric chamber is defined by the following equation: where:

[0108] • u(t) is the control signal to be applied to the system at time t;

[0109] •e(t) is the instantaneous error at time t, calculated as the difference between the reference value (set-point) and the current output of the system;

[0110] . Kp is the proportional gain, which determines the magnitude of the system response in proportion to the error. Increasing Kp, the proportional control effect increases;

[0111] • Ki is the integral gain, which considers the integral of the error over time and helps to eliminate the steady-state error. Increasing Ki, the steady-state error elimination effect increases;

[0112] • Kd is the derivative gain, which considers the rate of change of the error over time. It helps to reduce overshoot and improve system stability. Increasing Kd, the derivative control effect increases. The above equation and other minor parameters are implemented in the application software of the hyperbaric chamber.

[0113] Description of the copper pipelines entering the hyperbaric chamber

[0114] The copper pipelines entering the hyperbaric chamber perform several essential functions for the proper operation and safety of the chamber itself. Said copper pipelines mainly have the following main purposes inside the hyperbaric chamber:

[0115] • oxygen provision: one of the main reasons a hyperbaric chamber operates is to provide high-pressure oxygen; the copper pipelines transport the oxygen from the external source, such as a cylinder, inside the hyperbaric chamber; high-pressure oxygen increases the amount of oxygen dissolved in the blood, thus promoting the healing of tissues and injuries;

[0116] • compressed air provision: said copper pipelines are used to provide compressed air inside the hyperbaric chamber, which helps to increase atmospheric pressure; compressed air can be purified and heated to ensure the safety and comfort of the people inside the chamber;

[0117] • pressure regulation: the copper pipelines are essential for controlling the pressure inside the hyperbaric chamber; a pressure control system regulates the amount of air or gas, such as oxygen, entering the chamber to maintain the desired hyperbaric pressure during treatment;

[0118] • safety and air evacuation: the copper pipelines play an important role in ensuring safety inside the hyperbaric chamber; during treatment, it is essential to ensure that air is continuously supplied and filtered to avoid the presence of harmful gases or dangerous oxygen levels; the pipelines can also allow for the quick evacuation of air from the chamber in case of emergency.

[0119] Moreover, copper is often used for pipelines as it is a corrosion-resistant material, making it suitable for the humid and pressurized environment inside the hyperbaric chamber. In summary, the copper pipelines play a crucial role in providing the necessary oxygen, regulating the pressure, and ensuring safety inside the hyperbaric chamber during medical treatments.

[0120] Audio and video intercom subsystem for the hyperbaric chamber

[0121] The audio and video intercom system of the hyperbaric chamber is of the wireless type, carefully designed to ensure the safety and reliability of the installation. Said audio and video intercom system is made according to the guidelines described below:

[0122] • research and compliance with regulations: the audio and video intercom system follows all safety regulations and guidelines related to the use of electronic devices inside hyperbaric chambers; the system meets all requirements and certifications related to ATEX Zone 1 systems;

[0123] • accurate selection of the components: all selected equipment is suitable for the hyperbaric environment; the electronic components of the intercom system, such as cameras, microphones, speakers, and cables, are capable of withstanding high pressures and the specific conditions of the hyperbaric chamber; • audio communication system: a microphone is installed inside the chamber for clearly listening to the voices of patients and / or personnel inside the chamber;

[0124] • video communication system: the cameras installed inside the hyperbaric chamber allow to monitor patients and personnel from the outside. High-definition cameras (pressure-resistant) are used to ensure a clear and detailed view;

[0125] • signal transmission: the wireless, audio, and video signal transmission from inside the hyperbaric chamber to the outside is made with electromagnetic radiation low-power radio components; the adopted components are suitable for working in pressurized environments. The frequency range is that of UHF and / or Wi-Fi devices operating at 2.4 GHz and 5 GHz;

[0126] • external monitor and control: outside the hyperbaric chamber, in the operator station console, it is possible to display the images from the internal cameras on the monitor as well as control and manage the intercom;

[0127] • before operating the system: the operational protocol, also available in the operator console, provides mandatory rigorous safety and functionality tests to ensure that all functionalities are operating and that there are no risks for patients or personnel; furthermore, regular maintenance procedures should be planned to ensure that the system remains in optimal conditions.

[0128] Safety system for fire risk Mitigating the fire risk in the hyperbaric chamber is crucial to ensure the safety of personnel and patients inside the pressurized environment. Being a controlled environment with high-pressure oxygen, the fire risk can be greater than in a normal atmospheric pressure environment. The chamber is provided with adequate sensors that are alarmed in real time in case of fire (IR [infrared] detectors sensitive to quick changes of ambient temperature). The hyperbaric chamber is provided with a circuit of independent pipelines that carry the water necessary to extinguish a fire starting in the bud. The fire risk mitigation measures implemented in the hyperbaric chamber are described below:

[0129] • fire-resistant materials: the interiors of the chamber and all materials used therein are fire-resistant or low-fire-risk; this includes fabrics, paddings, coatings, and other components present inside the chamber;

[0130] • oxygen control: the oxygen levels inside the hyperbaric chamber are accurately monitored by the PLC so as to ensure they are maintained at safe levels; excessively high oxygen levels can significantly increase the fire risk; medical personnel must strictly follow the guidelines for oxygen administration and use safe and well-maintained equipment;

[0131] • limitation of spark and heat sources: it is essential to avoid introducing electrical devices, equipment, or materials that could generate sparks or heat inside the hyperbaric chamber; in the operator console computer, the control procedure that contains special precautions to be followed mandatorily in case it is indispensable to introduce electrical devices, is available; these must be certified for use in hyperbaric environments; • constant surveillance: the hyperbaric chamber is constantly monitored by the computerized system during treatments; personnel must be trained to promptly recognize any signs of danger or risky situations;

[0132] • limitation of metal objects: limit metal objects inside the hyperbaric chamber as they can be dangerous in case of fire; however, copper is often used for pipelines due to its corrosion resistance and can be safe if used correctly;

[0133] • personnel training: it should be ensured that all personnel involved in hyperbaric therapy are adequately trained on safety measures and emergency procedures in case of fire; safety is an absolute priority in managing a hyperbaric chamber, and these fire risk mitigation measures contribute to ensure a safe environment for patients and personnel.

[0134] Therefore, the object of the present invention is a hyperbaric device for medical and / or therapeutic use, comprising a shelter, made of composite material, further comprising:

[0135] • an operator console (1) connected to a PLC (6);

[0136] • an electric panel (8);

[0137] • a hyperbaric chamber (7) comprising: o an inlet door (2); o a control porthole (3); o a pass-through window (4), made with materials selected from the group comprising: alloys of aluminium, stainless steel, and / or a combination thereof; o air, oxygen, and water pipelines (5); o oxygen and air cylinders (9), connected to the pipelines (5), and wherein:

[0138] - the inlet door (2) is made of metal material and composite material elements (10);

[0139] - the hyperbaric chamber (7) has metal supports (11);

[0140] - said hyperbaric device comprises the following subsystems / devices:

[0141] • an air compressor, useful for providing compressed air inside the hyperbaric chamber (7) to increase the pressure;

[0142] • a pressure control system useful for regulating and maintaining the pressure inside the hyperbaric chamber (7) at the required specifications for patient treatment;

[0143] • an oxygen provision system, useful for providing pure oxygen to obtain higher oxygen levels compared to ambient air;

[0144] • an exhaust gas delivery system, useful for removing exhaled gas from patients and maintaining a clean and safe environment inside the hyperbaric chamber (7);

[0145] • an audio and video communication system, useful for external personnel to continuously monitor the patient's health status and communicate with him / her via audio and video during treatment so as to provide any necessary assistance;

[0146] • beds and / or seats for patients, useful for patient comfort during treatment; a safety and emergency system. A further object of the present invention is a hyperbaric device for medical and / or therapeutic use, wherein the hyperbaric chamber (7) is made through the filament-winding process, which comprises the following processing steps:

[0147] STEP 1 - designing: all the specifications of the hyperbaric chamber (7), comprising dimensions, capacity, maximum operating pressure, and structural requirements, are defined;

[0148] STEP 2 - selecting the materials: selecting the type of reinforcing fiber comprises carbon fiber, glass fiber, Kevlar, and / or a combination thereof, as well as the appropriate resin based on the needs of the hyperbaric chamber (7);

[0149] STEP 3 - preparing the mandrel (15): a solid or hollow mandrel with the internal shape of the hyperbaric chamber (7) is made. The mandrel serves as the base, around which the fiber filaments (12) are wound;

[0150] STEP 4 - preparing the filaments: the fiber filaments (12) are immersed in the resin (13) to ensure good adhesion between fiber and resin during winding;

[0151] STEP 5 - filament-winding: the fiber filaments (12) are wound around the mandrel (15) in a precise and controlled manner;

[0152] STEP 6 - finishing layer: after the winding of step 6 is completed, a resin finishing layer is added to improve the strength and surface finishing of the hyperbaric chamber (7);

[0153] STEP 7 - curing: the hyperbaric chamber (7), at the end of step 6, is placed in a curing chamber where the resin is hardened through heat;

[0154] STEP 8 - removing the mandrel: after the resin is completely hardened, the hyperbaric chamber (7) can be removed from the mandrel (15); STEP 9 - quality tests and controls: the finished hyperbaric chamber (7) undergoes preliminary quality tests and controls to verify the strength, seal, and structural integrity thereof;

[0155] STEP 10 - finishing: the hyperbaric chamber (7) undergoes finishing operations such as smoothing and painting to meet the aesthetic and functional requirements;

[0156] STEP 11 - special treatments: in order to obtain the maximum safety in the use of the hyperbaric chamber (7), the composite components of said hyperbaric chamber (7), internally and externally, are subjected to a further treatment with a paint with antistatic and dissipative charges;

[0157] STEP 12 - further finishing: the hyperbaric chamber (7) undergoes further finishing operations such as smoothing and painting to meet the aesthetic and functional requirements.

[0158] A further object of the present invention is a hyperbaric device for medical and / or therapeutic use, wherein the inlet door (2):

[0159] • is made with pressure-resistant materials, such as carbon and / or glass fiber composite materials;

[0160] • has gaskets and sealing systems to ensure a hermetic seal of said inlet door (2) during the operation of the hyperbaric chamber (7);

[0161] • is designed so as to be opened and closed in a controlled and safe manner through blocking mechanisms or screw closures;

[0162] • is designed with an emergency system to allow the quick and safe exit of patients and personnel if necessary.

[0163] A further object of the present invention is a hyperbaric device for medical and / or therapeutic use, wherein the control of the ambient pressure inside the hyperbaric chamber (7) is carried out by means of an automatic regulation system based on PLC, which monitors and regulates the internal pressure of the chamber to maintain it at the desired level.

[0164] A further object of the present invention is a hyperbaric device for medical and / or therapeutic use, wherein the algorithm for controlling the pressure in the hyperbaric chamber (7) is implemented using a proportional controller and / or a PID controller.

[0165] A further object of the present invention is a hyperbaric device for medical and / or therapeutic use, wherein the pipelines (5) are made of copper and are useful for:

[0166] • transporting high-pressure oxygen from the cylinders (9) inside the hyperbaric chamber (7);

[0167] • transporting compressed air from the cylinders (9) inside the hyperbaric chamber (7);

[0168] • regulating the pressure inside the hyperbaric chamber (7) through a control system;

[0169] • allowing the quick evacuation of air from the hyperbaric chamber (7) in case of emergency.

[0170] A further object of the present invention is a hyperbaric device for medical and / or therapeutic use, wherein the audio and video communication system of the hyperbaric chamber (7): is of the wireless type; meets all safety regulations related to the use of electronic devices inside hyperbaric chambers; • is made with electronic components capable of withstanding high pressures and the specific conditions of the hyperbaric chamber (7);

[0171] • has, inside the hyperbaric chamber (7), a microphone useful for clearly listening to the voices of patients and / or personnel;

[0172] • has, inside the hyperbaric chamber (7), high-definition cameras useful for monitoring patients and personnel from the outside;

[0173] • the transmission of wireless, audio, and video signals from inside the hyperbaric chamber (7) to the outside is made with electromagnetic radiation low-power radio components;

[0174] • has an operator console (1), placed outside the hyperbaric chamber (7), useful for displaying the images from the internal cameras as well as controlling and managing the intercom.

[0175] A further object of the present invention is a hyperbaric device for medical and / or therapeutic use, provided with:

[0176] • sensors that are alarmed in real time in case of fire;

[0177] • a circuit of independent pipelines that carry the water necessary to extinguish a fire starting in the bud;

[0178] • fire-resistant or low-fire-risk materials.

[0179] A further object of the present invention is a hyperbaric device for medical and / or therapeutic use, wherein the hyperbaric chamber (7) is tested and certified:

[0180] • for shock and vibrations in the naval field;

[0181] • in order to be free from susceptibility and / or radio frequency emissions.

[0182] A further object of the present invention is a hyperbaric device for medical and / or therapeutic use, wherein the hyperbaric chamber (7) is made through materials selected from the group comprising: carbon fiber, glass fiber, aramid fiber, steel, aluminium, zinc, paints with antistatic and dissipative charge and / or a combination thereof.

Claims

CLAIMS1. A hyperbaric device for medical and / or therapeutic use, comprising a shelter, made of composite material, further comprising:• an operator console (1) connected to a PLC (6);• an electric panel (8);• a hyperbaric chamber (7) comprising: o an inlet door (2); o a control porthole (3); o a pass-through window (4), made with materials selected from the group comprising: alloys of aluminium, stainless steel, and / or a combination thereof; o air, oxygen, and water pipelines (5); o oxygen and air cylinders (9), connected to the pipelines (5), and wherein:- the inlet door (2) consists of metal material elements and composite material (10);- the hyperbaric chamber (7) has metal supports (11);- said hyperbaric device comprises the following subsystems / devices:• an air compressor, useful for providing compressed air inside the hyperbaric chamber (7) to increase the pressure;• a pressure control system useful for regulating and maintaining the pressure inside the hyperbaric chamber (7) at the required specifications for patient treatment;• an oxygen provision system, useful for providing pure oxygen to obtain higher oxygen levels compared to ambient air;• an exhaust gas delivery system, useful for removing exhaled gas from patients and maintaining a clean and safe environment inside the hyperbaric chamber (7);• an audio and video communication system, useful for external personnel to continuously monitor the patient's health status and communicate with him / her via audio and video during treatment, so as to provide any necessary assistance;• beds and / or seats for patients, useful for patient comfort during treatment;• a safety and emergency system;- the hyperbaric chamber (7) is made through a filament-winding process, which comprises the following processing steps:STEP 1 - designing: all the specifications of the hyperbaric chamber (7), comprising dimensions, capacity, maximum operating pressure, and structural requirements, are defined;STEP 2 - selecting the materials: selecting the type of reinforcing fiber comprises carbon fiber, glass fiber, Kevlar®, and / or a combination thereof, as well as the appropriate resin based on the needs of the hyperbaric chamber (7);STEP 3 - preparing the mandrel (15): a solid or hollow mandrel with the internal shape of the hyperbaric chamber (7) is made; the mandrel serving as the base, around which the fiber filaments (12) are wound;STEP 4 - preparing the filaments: the fiber filaments (12) are immersed in the resin (13) to ensure good adhesion between fiber and resin during winding;STEP 5 - filament-winding: the fiber filaments (12) are wound around the mandrel (15) in a precise and controlled manner;STEP 6 - finishing layer: after the winding of step 6 is completed, a resin finishing layer is added to improve the strength and surface finishing of the hyperbaric chamber (7);STEP 7 - curing: the hyperbaric chamber (7), at the end of step 6, is placed in a curing chamber where the resin is hardened through heat;STEP 8 - removing the mandrel: after the resin is completely hardened, the hyperbaric chamber (7) can be removed from the mandrel (15);STEP 9 - quality tests and controls: the finished hyperbaric chamber (7) undergoes preliminary quality tests and controls to verify the strength, seal, and structural integrity thereof;STEP 10 - finishing: the hyperbaric chamber (7) undergoes finishing operations such as smoothing and painting to meet the aesthetic and functional requirements;STEP 11 - special treatments: in order to obtain the maximum safety in the use of the hyperbaric chamber (7), the composite components of said hyperbaric chamber (7), internally and externally, are subjected to a further treatment with a paint with antistatic and dissipative charges;STEP 12 - further finishing: the hyperbaric chamber (7) undergoes further finishing operations such as smoothing and painting to meet the aesthetic and functional requirements.

2. The hyperbaric device of claim 1, wherein the inlet door (2):• is made with pressure-resistant materials, such as carbon fiber and / or glass fiber composite materials; has gaskets and sealing systems to ensure a hermetic seal of said inlet door (2) during the operation of the hyperbaric chamber (7);• is designed so as to be opened and closed in a controlled and safe manner through blocking mechanisms or screw closures;• is designed with an emergency system to allow the quick and safe exit of patients and personnel if necessary.

3. The hyperbaric device of claim 1, wherein the control of the ambient pressure inside the hyperbaric chamber (7) is carried out by means of an automatic regulation system based on a PLC, which monitors and regulates the internal pressure of the chamber to maintain it at the desired level.

4. The hyperbaric device of claim 1, wherein the algorithm for controlling the pressure in the hyperbaric chamber (7) is implemented using a proportional controller and / or a PID controller.

5. The hyperbaric device of claim 1, wherein the pipelines (5) are made of copper and are useful for:• transporting high-pressure oxygen from the cylinders (9) inside the hyperbaric chamber (7);• transporting compressed air from the cylinders (9) inside the hyperbaric chamber (7);• regulating the pressure inside the hyperbaric chamber (7) through a control system;• allowing the quick evacuation of air from the hyperbaric chamber (7) in case of emergency.

6. The hyperbaric device of claim 1, wherein the audio and video communication system of the hyperbaric chamber (7) : is of the wireless type;• meets all safety regulations related to the use of electronic devices inside hyperbaric chambers;• is made with electronic components capable of withstanding the high pressures and specific conditions of the hyperbaric chamber (7);• has, inside the hyperbaric chamber (7), a microphone useful for clearly listening to the voices of patients and / or personnel;• has, inside the hyperbaric chamber (7), high-definition cameras useful for monitoring patients and personnel from the outside;• the transmission of wireless, audio and video signals from inside the hyperbaric chamber (7) to the outside is made with electromagnetic radiation low-power radio components;• has an operator console (1), placed outside the hyperbaric chamber (7), useful for displaying the images from the internal cameras as well as controlling and managing the intercom.

7. The hyperbaric device of claim 1, provided with:• sensors that are alarmed in real time in case of fire;• a circuit of independent pipelines that carry the water necessary to extinguish a fire starting in the bud;• fire-resistant or low-fire-risk materials.

8. The hyperbaric device of claim 1, wherein the hyperbaric chamber (7) is tested and certified:• for shock and vibrations in the naval field;• in order to be free from susceptibility and / or radio frequency emissions.

9. The hyperbaric device of claim 1, wherein the hyperbaric chamber (7) is made through materials selected from the group comprising: carbon fiber, glass fiber, aramid fiber, steel, aluminium, zinc, paints with antistatic and dissipative charge and / or a combination thereof.

Images