DESCRIPTION

The present invention relates to a system for preventing and treating decubitus damage. Such a system comprises a support whereon the patient is positioned. Such a support can be an anti-decubitus mattress or an anti decubitus cushion for a chair. The anti-decubitus mattress is a device for preventing and treating bedsores or pressure ulcers, which can be used in hospital facilities or for home care. The anti-decubitus cushion is used in the evolution of the treatment or as an independent device.

As it is well known, pressure ulcers are developed when the compressive force between the body surface and the supporting surface is higher than the pressure in the arteriole-capillary district, creating a condition of vessel collapse and secondary tissue ischemia. This occurs when a pressure force higher than 32 mmHg is applied to an area of skin for a sufficiently prolonged time (at least two hours). Tissues are differently sensitive to oxygen lack: under conditions of persistent ischemia, the formation of necrotic tissue occurs in the deep (muscle) layers before the problem appears on the surface, therefore the progression of the ulcer extends from the deep levels to the superficial levels. When the ulcer becomes visible superficially (as an erythematous, ecchymotic, or clearly ulcerated area), in most cases the underlying tissues are already compromised. Anti-decubitus mattresses are known on the market, which simply redistribute the body weight of the patient over the entire surface of the mattress, in such a way to reduce or eliminate pressure peaks on the mattress. However, said anti-decubitus mattresses are not capable of preventing or treating pressure sores. Additionally, the anti-decubitus mattresses of the prior art are unable to detect the position of the patient. Therefore, if the physician requires a therapy based on the position of the patient, the device is not able to apply a suitable therapy for the new position of the patient. In order to detect the position of the patient, special devices that are complex, expensive and difficult to sanitize must be provided.

US20130090571 describes a method for preventing and treating pressure ulcers by using a sensorized sheet that performs a pressure mapping in different parts of a patient's body. The acquired pressure data are used for a more effective repositioning of the patient.

W099/42070A1 describes a cushion or mattress comprising cells filled with an elastic, porous material that can be configured by varying the height of the cell by applying a negative pressure. According to an embodiment of the invention, a pressure sensor in each cell is disclosed, but it is not disclosed that the cell also has a valve and a control board. Each pressure sensor is electrically connected to a processor disposed in an external control unit. Each cell is pneumatically connected via a conduit to a valve manifold arranged in the external control unit. Therefore, in the case of n cells, it is necessary to have n+1 wires to carry the signals from the pressure sensors to the processor, n tubes to connect the cells to the manifold, and n 3-way valves disposed in the manifold in order to inflate and deflate the cells. Such a configuration may be suitable for a cushion, but is not suitable for a mattress due to the excessive number of electrical and pneumatic connections. Such a document does not describe a pressure balancing of the cells, but a sequential system of height variation of the cells (massage type or pressure wave with lateral movement), for a cyclic operation defined by cycle time, deflation time, deflation area.

CN107693261 A describes a mattress provided with twenty horizontal cylinders, grouped into four blocks of five cylinders, which correspond to head, chest, pelvis, and legs, and two side cylinders in longitudinal position. No pressure sensor, valve or control board is provided within the cylinders. In fact, an external control unit is connected to the mattress by means of six tubes. The control unit contains a microprocessor, a display, a valve manifold, and a pressure sensor. Such a document does not describe a pressure balancing of the cylinders and describes four fixed programs (Sport, Wave, Sideways, Sleep) that alternately inflate/deflate the cylinders, regardless of the pressure peaks on each cylinder. US2014/0026326A1 describes a conventional mattress, under which height-adjustable pneumatic pistons are interposed, by means of a rotary distributor that sequentially connects said pistons to an external control unit. The pistons are arranged in fifteen rows (8 rows of 10 pistons and 7 rows of 9 pistons, alternating with each other). The mattress is airtight, so that the pistons remain in place. The distribution system connects only three pistons at a time, measures the pressure and provides for inflation/deflation by means of a three- way valve disposed on the outside of the mattress. Such a mattress is not applicable to a hospital bed because it cannot be folded due to the presence of the pistons. In addition, the updating process of the pressure in all the pistons of the mattress is very slow, since only three pistons are connected at a time.

US4864671A describes a cushion that is divided into cells that can be inflated by rows or zones. The cells are organized into rows controlled by a system that controls the pressure with a microprocessor disposed in an external control unit. The rows/zones are connected by means of a tube to a three-way valve for inflation/deflation disposed in the external control unit. The inflation pressure of the rows is set using a Hex switch and is indicated with LEDs. Such a document discloses simple inflation/deflation cycles, and not a pressure balancing operation of the cells.

The purpose of the present invention is to eliminate the drawbacks of the prior art by disclosing an anti-decubitus system that is capable of uniformly redistributing the weight of the patient on a mattress in an autonomous way.

Another purpose of the present invention is to provide such an anti decubitus system that is capable of detecting the position of the patient on the mattress and adjusting the mattress according to the position of the patient and to the prescriptions of the physician.

A further purpose of the present invention is to disclose such an anti decubitus system that is capable of identifying the position of a bedsore, or of damage in the initial phase, and adjusting the mattress according to the detected situation.

An additional purpose of the present invention is to disclose such an anti-decubitus system that is versatile, effective, reliable, with customizable operation parameters according to the physical features of the patient (height, weight, maximum time permitted in a given position, etc.), simple to operate and easy to sanitize.

These purposes are achieved according to the invention with the characteristics of the independent claims.

Advantageous embodiments of the invention appear from the dependent claims.

The anti-decubitus system of the invention comprises a support whereon the patient is positioned. The support comprises independent cells controlled by a microprocessor, which are capable of measuring the pressure exerted by the body of the patient. A control unit is connected to the support and is able to modify the inflation pressure of the cells, with the aim of redistributing the weight of the patient on the cells, thus avoiding the risk of subjecting sensitive areas of the patient to ischemic damage (in particular, sacrum-coccyx, ischial tuberosities, calcaneus, occiput) and to pressure peaks due to the permanence of the patient in a given position for a prolonged time.

In any case, the inflation pressure of the cells must not exceed the preset limit value of 32mmHg, which is responsible for ischemic damage in the areas of the patient that are subjected to such pressure.

The continuous pressure rebalancing within values that do not exceed the preset limit is the mechanism used by the anti-decubitus system in order to prevent decubitus ulcers.

The anti-decubitus system is also capable of detecting the onset of decubitus thanks to the use of a magnetic indicator that is positioned in a damaged part of the patient. The presence of the magnetic indicator is detected by the affected cells and is communicated to the control unit which provides for a pressure discharge action in the affected cells. In view of the above, the mattress becomes a medical aid because the cells corresponding to the damaged tissue modify their basic functions, creating a depression without redistributing the pressure. Such a discharge zone allows for a better vascular and lymphatic circulation of the damaged tissues, favoring tissue repair. Finally, the intelligent features of the anti-decubitus system allow for modifying the functions in relation to the patient's needs. Depending on the individual characteristics (patient's weight, cooperating or uncooperating patient, possibility of modifying the decubitus) and on the potential or actual injuries (site of injury, extent of damage), the anti-decubitus system may respond to each case in a different, appropriate way, thus becoming a tool for personalized treatment and research activity.

Additional features of the invention will be clearer from the following description, which refers to merely illustrative, not limiting embodiments, as shown in the appended figures, wherein:

Fig. 1 is a top view of the anti-decubitus system according to the invention, in the embodiment of a mattress;

Fig. 1 A is a partially interrupted perspective view of a portion of the anti decubitus mattress of Fig. 1 disposed in a cover;

Fig. is a perspective view of a slat of the mattress of Fig. 1 , whereon the cells are fixed;

Fig. 2 is a block diagram of a pneumatic circuit of the system of Fig. 1 ;

Fig. 3 is a block diagram of a control board of a single cell of the anti decubitus system of Fig. 1 ;

Fig. 3A is a perspective view of a cell;

Fig. 3B is a perspective view of a support of a cell;

Fig. 4 is a block diagram of the control unit of the anti-decubitus system of Fig. 1 ;

Fig. 5 is a perspective diagrammatic view that shows the position of a magnetic indicator in order to activate a treatment functionality;

Fig. 6 is a block diagram that shows the connection of multiple anti decubitus systems according to the invention to a local telecommunication network;

Fig. 7 is a perspective view of the anti-decubitus system according to the invention, in the embodiment of an anti-decubitus cushion;

Fig. 8 is a perspective view of a slat of the cushion of Fig. 7;

Fig. 8A is a perspective view of a cell of the slat of Fig. 8; Fig. 9 is an exploded perspective view of the assembly parts of a cell of the cushion of Fig. 7;

Fig. 10 is a block diagram that shows all possible communications of the anti-decubitus system in the form of a cushion and of a mattress.

With reference to the Figures, the anti-decubitus system according to the invention is disclosed, which is generally indicated with reference numeral 100.

With reference to Fig. 1 , the anti-decubitus system (100) comprises an anti-decubitus support (1 ) whereon the patient is to be positioned.

Fig. 1 shows an anti-decubitus support (1 ) that comprises a mattress (1 ), such as for example a traditional mattress suitable for being disposed on a standard hospital bed.

The anti-decubitus support (1 ) comprises a plurality of cells (10) disposed along a grid of rows and columns.

With reference to Fig. 1 B, each row of the grid of cells comprises a slat (12) composed of a support whereon a plurality of cells (10) is mounted. Fig. 1 B shows eight cells (10) mounted on a slat (12).

The anti-decubitus support (1 ) comprises tubular elements (13a, 13b, 13c, 12d) of inflatable type that surround the cells (10). For illustrative purposes, four tubular elements are provided. The tubular elements (13a, 13b, 13c, 12d) perform a double action, namely they accumulate the air and they contain the cells (10).

With reference to Fig. 1A, the anti-decubitus support (1 ) comprises a casing (5). The casing (5) comprises:

- a lower cover (50) made of a flexible, heavy material, provided with handles:

- an upper cover (51 ) made of a sanitizable material suitable for medical uses.

The two covers (50, 51 ) of the casing are joined by a zipper (52) that extends for the entire perimeter of the casing. In particular, the upper cover (51 ) can be replaced for hygienic needs, if necessary. With reference to Figs. 3A and 3B, each cell (10) comprises a bubble (9) that defines a chamber suitable for being inflated with compressed air. Each cell (10) comprises a control board (8) mounted on a support (16) disposed in a housing of the slat (12). The control board (8) performs multiple functions, as it will be described hereinafter in detail.

With reference to Fig. 1 , the anti-decubitus system (100) comprises:

- an electrical power supply (24) that provides energy in DC mode to power all the control boards (8) of the cells;

- a pneumatic pump (34) that provides the compressed air necessary for initially inflating the bubbles (9) and the tubular elements (13a, 13b, 13c, 13d) for a dynamic operation of the anti-decubitus support (1 ); and

- a processor (3) used to control the cells (10), collect the data, and apply the treatments defined by the physician.

A display (40) and a Wi-Fi keyboard can be connected to the processor (3) to display the current parameters of the system (100) by the bedside or to program the system (100).

The system (100) can be also programmed online with a tablet or from a control station.

If the anti-decubitus support (1 ) is a mattress, the dimensions of the anti decubitus support (1 ) are 200 x 90 cm. With reference to Fig. 1 , the anti decubitus support (1 ) comprises nineteen slats (12) that extend transversally. The structure with transverse slats is necessary to ensure compatibility with hospital beds, which are articulated in four sections: bust (cervicodorsal), glutei (sacroiliac), thigh (femoral), leg (tibia, fibula, heel).

Each slat (12) supports eight cells (10). Therefore the anti-decubitus support (1 ) comprises 152 cells.

The slat (12) is made of a box parallelepiped structure that is shaped like a strip of flexible material (foam polypropylene) so that the anti-decubitus support (1 ) can adjust to the articulation of the bed.

The pump (34), the power supply (24) and the processor (3) are contained in a control unit (2) that will be described hereinafter in detail. With reference to Figs. 3, 3A and 3B, the cell (10) is a smart unit that comprises the bubble (9) and the control board (8). The bubble (9) is shaped like an overturned truncated-pyramid with a major basis of 10x10 cm and a height of 12 cm.

The control board (8) of each cell is mounted on the support (16) that simplifies the electric wiring of the control board (8) and the pneumatic wiring of the bubble (9).

The control boards (8) of the cells (10) of each slat (12) are electrically connected to a connection bus (46) of 3-wire type. The connection buses (46) of all slats are connected to a main bus (29) that comprises three wires: two power supply wires (21 , 22) and one data wire (23).

The power supply wires (21 , 22) of the main bus (29) are connected to the power supply (24) of the control unit (2). In view of the above, all control boards (8) of the cells (10) are electrically powered.

The data wire (23) of the main bus (29) is connected to the processor (3) of the control unit (2). In view of the above, each control board (8) can exchange data with the processor (3) in a client-server mode.

The bubbles (9) of the cells of a slat are pneumatically connected to a connection duct (17) that passes from a support (16) to another support (16) in the slat until it reaches a distribution duct (30) (Fig. 2).

With reference to Fig. 3, each cell (10) comprises:

- a pressure sensor (11 ) to measure the absolute pressure inside the bubble (9); and

- a solenoid valve (19) disposed in a derivation duct (44) that connects the bubble (9) to the connection duct (17) of the slat.

The solenoid valve (19) is controlled by the control board (8) based on the pressure measured by the pressure sensor (11 ), in such a way to inflate or deflate the bubble (9).

The cell (10) operates autonomously for multiple variation or measurement operations of the bubble pressure.

The cell (10) further includes a magnetic sensor (18) mounted on the control board (8). The magnetic sensor (18) is capable of measuring the intensity of a static magnetic field, such as the one provided by a magnetic element (89) (Fig. 5) of a magnetic indicator positioned on the patient. The smaller the distance from the magnetic element (89), the higher the intensity of the magnetic field measured by the magnetic sensor (18) will be.

Each cell (10) performs the following functions:

- it measures the air pressure inside the bubble (9) by means of the pressure sensor (11 );

- it controls the solenoid valve (19) for connecting the bubble (9) to the distribution duct (30);

- it measures an intensity of the magnetic field in the proximity of the cell by means of the magnetic sensor (18);

- it communicates with the processor (3) to send the data measured by the sensors and receive the commands to be implemented.

The pressure sensor (11 ) and the magnetic sensor (18) are embedded in the control board (8).

With reference to Fig. 2, each cell (10) of the mattress has a univocal identification address composed of a row number and of a column number. In fact, the cells are disposed according to a grid of 19 rows and 8 columns.

1.1 1.8 19.1 19 8

The control board (8) of each cell is equipped with a firmware (set of control programs of the microprocessor of the control board) and therefore it is capable of executing commands, in total autonomy, upon request of the processor (3).

The processor (3) can send specific commands to each cell (10) (recognized from its univocal address) or commands to all of the cells simultaneously (broadcast).

Data reading is performed by means of a communication between the processor (3) and each individual control board (8) in a sequence. The data provided by a control board (8) is: Pressure (pressure value), Magnetic (magnetic field value), Occupied (occupied or free), Active (active or not active), Ton (solenoid valve T open/closed), Pon (solenoid valve P open/closed). The processor (3) checks the correctness and the reliability of the transmitted or received data.

The firmware of each control board (8) of a cell is capable of executing a number of direct commands or broadcast commands.

Some of the instructions provide for help tasks for the operators in charge of repair. For example, some instructions in the control board (8) of each cell allow for changing the addresses of each cell (in case of replacement of a cell or of an entire slat with eight cells due to malfunction). Programs used for production tests of the system (100) are stored in the processor (3).

The firmware of each control board (8) can be updated in case of development of new commands or behaviors to be performed by the cell.

The anti-decubitus system (100) is of compensated pneumatic type, that is to say, its operation and the data detected by the pressure sensors (11 ) of each cell are independent from the environmental situation wherein the system is installed. Otherwise said, the anti-decubitus system (100) is insensitive to the altitude of the environment wherein it is used (sea or mountain level) and to the variations of the atmospheric pressure (good or bad weather).

A calibration operation of the system (100) is regularly repeated several times in an hour. An atmospheric pressure value of the location of the mattress is measured and communicated to all cells (10). In this way, the system (100) only considers the pressure exerted by the body of the patient on the device, regardless of the atmospheric pressure.

The anti-decubitus support (1 ) comprises an air accumulation system (13) comprising the four tubular elements (13a, 13b, 13c, 13d) of inflatable type, arranged around the perimeter of the grid of cells (10) Said tubular elements comprise a front tubular element (13a), a back tubular element (13b), a right tubular element (13c) and a left tubular element (13d).

With reference to Fig. 2, each slat (12) is pneumatically connected to the distribution duct (30) by means of the connection ducts (17) of the slat.

The distribution duct (30) is part of a pneumatic system (S) of the anti decubitus system (100). If the pneumatic system (S) comprises the accumulation system (13), said accumulation system (13) is connected by means of a distributor (33) to the pump (34) and to the distribution duct (30). In view of the above, it is not necessary to operate the pump (34) continuously because the compressed air in the distribution duct (30) is taken from the accumulation system (13) and therefore the pump (34) is switched on only for the time necessary to fill the accumulation system (13) with air. In such a way, it is possible to reduce the operating noise with respect to the systems where the pump is operated continuously.

For illustrative purposes, the pump (34) can be a diaphragm pump. A unidirectional valve (35) is disposed between the pump (34) and the distributor (33).

The control unit (2) comprises a transformer (36) that is electrically connected to the electrical mains and to the pump (34) in order to electrically power the pump. A relay switch (37) is disposed between the transformer (36) and the pump (34). The relay switch (37) is controlled by a first control cell (C1 ) controlled by the processor (3).

The unidirectional valve (35) and the first control cell (C1 ) maintain the accumulation system (13) at a constant pressure. When the accumulation system (13) reaches the desired pressure, the first control cell (C1 ) controls the relay switch (37) that stops the pump (34).

The distribution duct (30) is connected to the distributor (33) by means of an air inlet valve (31 ) in order to take the air from the distributor (33) towards the distribution duct (30). A discharge valve (32) connects the distribution duct (30) to a discharge towards the exterior. The air inlet valve (31 ) and the discharge valve (32) are solenoid valves controlled by a second control cell (C2) controlled by the processor (3).

Such an air distribution system, in conjunction with a time sharing technique implemented by the programs of the processor (3), allows for using only one solenoid valve (19) for each cell (10) for inflating and deflating the bubble (9). The solenoid valves (19) of the cells are normally closed, and so are the inlet valves and the discharge valves (31 , 32).

If, based on the pressure data measured by the pressure sensors (11 ) of the cells (10) and on the parameters set by the physician, the processor (3) detects that some of the bubbles (9) are to be deflated, then the processor (3) opens the discharge valve by means of the second control cell (C2) and informs the cells that deflation can begin. Consequently, the air exits from the bubbles (9), reaches the distribution duct (30) through the connection duct (17) of the slat (12) and is discharged outside. When each bubble (9) has reached the desired pressure, the control board (8) of each cell closes the relative solenoid valve (19).

On the contrary, if, based on the data measured by the pressure sensors (11 ), the processor (3) detects that some of the cells (10) are to be inflated, then the processor (3) opens the inlet valve (31 ) by means of the second control cell (C2) and informs the cells that inflation can begin. As a result, the air from the accumulation system (13) of the pneumatic system (S) reaches the distribution duct (30) and is made available for the bubbles (9) through the connection duct (17) of the slat (12). The control board (8) of the cell opens the solenoid valve (19), inflating the bubble (9) at the desired pressure.

A third condition is possible, wherein the pressure load has to be redistributed among multiple cells. In such a case, the processor (3) sets the distribution duct (30) at an average pressure value of the bubbles (9) of the cells to be put in communication, and then the processor (3) closes the inlet valve and the discharge valve (31 , 32) controlled by the second control cell (C2). Finally, the processor (3) sends a command to the cells in order to open the solenoid valve (19). In view of the above, the pressure is rebalanced among multiple cells rapidly without consuming any air.

The anti-decubitus support (1 ) may comprise a mattress (Fig. 1 ) or a cushion (Fig. 7). The control units (2) are specific for the mattress or for the cushion. Such a diversity of the control units (2) is due to the different way in which the mattress or the cushion is used. The mattress is used in a hospital setting or in a home setting and requires a correct power supply from the electrical mains and suitable data connection resources (wired LAN or Wi-Fi). In particular, in a hospital setting, multiple devices may be used simultaneously and need to be interconnected.

With reference to Fig. 4, if the anti-decubitus support is a mattress, the control unit (2) embeds power supply and control systems of the anti-decubitus support (1 ) and is powered from the 230V AC mains.

The control unit (2) comprises the following devices:

- a bipolar switch (39) of luminous type;

- a toroidal insulation transformer (36) (230/230V, 200VA, Vis. 4500V) to guarantee a galvanic separation from the mains for safety problems in a medical setting;

- the processor (3) consisting in a mini PC, namely ASUS UN45 (Cel. D. core, RAM 4GB, HD 120GB SSD, Win 10P, Wi-Fi). The processor (3) has an HDMI port (28) suitable for being connected to the display (40) of the user interface and a USB adapter for a Wi-Fi wireless keyboard (optional);

- a secondary AC/DC power supply (25) (220V/19V 3.7 A, 45W) to power the mini PC of the processor;

- the main power supply (24) consisting in an AC/DC power supply (220V/12V 10A, 120W) to power the electrical circuits of the mattress, through the main bus (29), and a USB-Data bus converter (26) for making the connection (23) for the communications between mattress and processor (3);

- the pump (34) consisting in a diaphragm pump (220 V, 50 Hz, 6W, max. pressure approx. 200 mBar) for inflating the bubbles (9) of the cells;

- the relay switch (37) controlled by the first control cell (C1 ) in order to control the pump (34).

All the devices of the control unit (2) are housed in a box that is disposed near the anti-decubitus support (1 ).

The control unit (2) is electrically connected to the slats (12) by means of the main bus (29) (as shown in Fig. 1 ) that provides power supply and a data connection to the electrical devices of the cells (10). The control unit (2) is pneumatically connected to the distributor (33) of the pneumatic system by means of an air inlet tube (27).

With reference to Fig. 7, an anti-decubitus system (100) is disclosed, wherein the anti-decubitus support (1 ) comprises a cushion with 42 x 42 cm dimensions.

With reference to Fig. 8, the cushion (6) comprises seven slats (12) that extend longitudinally on a seating surface. The structure with longitudinal slats is necessary for the cushion to be compatible with a transverse curvature of medical chairs for patients. Moreover, each slat (12) is inclined downwards in correspondence with the last cell (10) in order to facilitate the seating in the area near the lower portion of the knees (popliteal cavity).

Each slat (12) supports seven cells (10). Therefore the cushion comprises 49 cells. The slat (12) is made of a strip of flexible material (foam polypropylene) in such a way that the cushion can adjust to the seating surface.

As described for the mattress, the cell (10) of the cushion is a smart unit composed of a bubble (9) shaped like an overturned truncated cone, with max. diameter of 6 cm and height of 5 cm, and associated with a microprocessor- based control board (8).

Fig. 9 is an exploded view of a cell (10) of the cushion. The cell (10) comprises:

- the bubble (9) mounted on a rigid surface (43);

- a derivation duct (44) for the connection between the bubble and the solenoid valve (19),

- the connection duct (17) for the connection between the bubbles,

- the connection bus (46) with 3 wires for power supply and data connection, which is connected to the main bus (29),

- the control board (8) mounted on the support (14);

- the slat (12);

- fixing elements (47).

The cells (9) of a slat are electrically connected by the connection bus (46) with 3 wires connected to the main bus (29) which provides power supply and data transmission from/to the processor (3). The cells (20) are interconnected by a duct that goes from a support to another support until the distribution duct (30).

In view of its use in a mobility condition, the anti-decubitus system with the cushion needs an autonomous power supply, such as a rechargeable battery (124) and a Wi-Fi or telephone data connection network (3G-4G).

The control unit (2) is similar to the one for the mattress, as described previously, with the following differences:

- power is supplied by the rechargeable battery (124) of adequate capacity (12V, 7.2 Ah);

- the isolation transformer is no longer necessary, and is replaced by a battery charger with charge limiter.

The pump (34) is a diaphragm pump with DC power supply. (12V DC, 0.7 A, 8.4 W), in conjunction with a tank with a capacity of about 2 liters and air accumulation system.

The processor (3) consists in a PC with adequate features for the device to be controlled (ASUS Vivo Stick, Atom processor, 2GB RAM, 32 GB Hard Disk SSD, USB interfaces, HDMI, Wi-Fi).

The control unit (2) is connected to the cushion by means of the main bus (29) with 3 wires for power supply-data connection, and a tube (27) that provides compressed air. The control unit (2) is enclosed in a container that can be hung as a backpack behind the chair or under the seating surface.

To recharge the battery (124) it is simply necessary to connect the control unit (2) to a power outlet with a detachable cable provided.

Going back to Fig. 1 , the anti-decubitus system (100) comprises three units:

- the anti-decubitus support (1 );

- the control unit (2); and

- the user interface (4) comprising the display (40), which can be a 15” color LCD, and a mini wireless keyboard (optional).

If it is a mattress, the anti-decubitus support (1 ) is obviously positioned on the bed with the slats (12) facing down and the bubbles (9) facing up. The control unit (2) contains the electrical and pneumatic devices and can be placed on the floor or can be hung from a bedside table. The 3-wire bus (29) and the tube (27) for the connection with the pneumatic part of the anti-decubitus support (1 ) start from the control unit (2).

Fig. 6 shows a hospital setting wherein a plurality of anti-decubitus systems are installed (100). The control unit (2) of each anti-decubitus system (100) can be controlled with a dedicated user interface (4), which can be disposed on the bed, for example, or with a PC (71 ) of a centralized station (70) (i.e. a nursing room), or with a portable terminal (7a), namely a tablet. The PC (71 ) and the tablet (7a) use the same application program, which is a Web App.

The centralized station (70) has a large-sized monitor (72) and a wireless keyboard (73). The monitor (72) shows a general situation of all the anti-decubitus systems (100) connected to the centralized station, and the real time condition of an individual anti-decubitus system (100). In view of the above, a physician can also see a hospitalization history of the patient who is positioned on one of the mattresses of the anti-decubitus system (100).

In order to control the anti-decubitus system (100) from the bed, particularly when the application is started or when a new patient is being treated, it is more useful to have a quick system for the implementation of the controlling and data entering functions. This can be accomplished with the user interface (4), which comprises a monitor and a keyboard that can be used to perform all the operations that are necessary for positioning a new patient on the mattress.

The data of the patient is stored in the PC (71 ) in order to facilitate consultation operations. The PC (71 ) stores a copy of the data in a Cloud (74) at regular intervals. When the permanence cycle of the patient on the mattress is completed, the data is transferred to the Cloud (74) and is removed from the PC (71 ). In this way, the retrievability of the data of hospitalized patients is immediate. However, if the physician wants to analyze the data of previously hospitalized patients, the data can be retrieved from the Cloud (74).

The phenomena controlled by the anti-decubitus system (100) are very slow. Moreover, it is necessary to prevent the anti-decubitus support (1 ) from responding too quickly to the variations in the posture of the patient, in order to prevent the patient from being uncomfortable or unstable. A variation in the way the patient is supported on the anti-decubitus support (1 ) must be compensated within tens of seconds and not immediately.

The purpose of the anti-decubitus system (100) is to avoid pressure peaks and evenly distribute the pressure on the bubbles (9) of the cells (10) of the mattress occupied by the patient. The human body has a different distribution of weights in its various parts. When the average pressure is equalized for all the bubbles (9) in the cells (10) occupied by the patient, this circumstance is manifested by a different height of the bubbles (9) (lower height for more loaded bubbles and higher height for less loaded bubbles).

The basic principles implemented in the anti-decubitus system (100) are:

- to detect the pressure exerted on the various cells (10) and to determine the cells occupied by the patient;

- to carry out variations in the inflation and deflation of the cells in order to modify the posture of the patient's body, in a slow manner, so as not to create a sense of instability;

- to try using as much as possible the air that is already inside the bubbles (9) or that has been loaded in the accumulation system (13) in order to avoid having to operate the pump (34) for a long time. In view of the above, the operating time and consequently the noise and vibration level of the pump is reduced;

- to limit the switching of the solenoid valves (19) of the cells in order to reduce noise interference.

The control system of the cells (10) is based on the Time Sharing principle. The inflation and deflation operations of the cells (10) and the rebalancing operations of the pressure take place according to a preset sequence that is repeated cyclically.

The processor (3) of the control unit (2) is suitably programmed so as to perform the following operations, in a repetitive mode:

• detection of the pressure of all bubbles (9) of the cells (10) of the mattress in such a way to map the status of all cells; • determination of the cells (10) in contact with the body of the patient and comparison with a previous map;

• verification of alarm conditions, when the pressure on a cell is higher than a preset threshold value;

• calculations (average pressure, correspondence with the weight of the patient, etc.);

• pressure rebalancing operations;

• overpressure discharging operations;

• inflating operations of the bubbles in contact with the body of the patient that are below a preset pressure;

• deflating operations of the bubbles in contact with the body of the patient that are above a preset pressure;

• inflating or deflating operations of the unoccupied bubbles in order to bring them to a standard pressure.

The software programs that regulate the processor (3) of the control unit follow four main steps that are repeatedly cyclically:

1 data reading checks and calculations

2 pressure balancing

1 data reading checks and calculations

3 overpressure discharge

1 data reading checks and calculations

4 pressure reset

Step 1 , namely data reading, checks and calculations, is always performed before each operating step 2, 3 and 4 and the step of data reading and calculations may provide for skipping the following operating step, if it is not necessary. In view of the above, a control system that is automatically reconfigured according to the needs is realized.

Such an operating mode uses only one solenoid valve (19) for each cell (10), but the distribution duct (30) of the pneumatic system performs a triple function:

- it provides pressurized air from the accumulation system (13);

- it acts as interconnection duct for balancing the cells; - it acts as exhaust duct to discharge excessive air.

The control of the distribution duct (30) is performed by the processor (3) through the second control cell (C2) that controls the inlet valve (31 ) and the exhaust valve (32). The distribution duct (30) has an inner diameter of less than 10 mm, preferably 6 mm, to slow down the inflation and deflation of the cells, so as to avoid abrupt variations. Furthermore, the distribution duct (30) has a length of about 2 m, and therefore its volume is about 60 cm ³ . So it is necessary to take such a volume into account and therefore the control cell (C2) of the distribution duct (30) also provides for measuring the pressure in the distribution duct and for regulating the pressure before it is occupied.

In addition, each cell (10) is equipped with a pressure sensor (11 ), so that during the inflation and deflation operations, the control board (8) of the cell closes the solenoid valve (19) of the cell when the pressure reaches the set value.

The ordinary operation of the anti-decubitus system (100) should be able to prevent decubitus damage thanks to the capability of redistributing the pressure under a threshold value of 32 mmHg.

In any case, with the onset of the first symptoms of decubitus damage, or in the presence of proven damage, the anti-decubitus system (100) offers a treatment function in the affected area, by automatically reducing the pressure. With reference to Fig. 6, such a condition is achieved by means of a magnetic indicator that comprises a magnet (89), in the shape of a disc and with the size of a coin with a diameter of 20 mm, applied near the affected skin area or in correspondence of a dressing.

The decubitus ulcer is treated in the traditional way, with the peculiarity that the magnet (89) is applied on the outside of the dressing.

Advantageously, the magnet (89) is enclosed in a silicone casing (90) which protects the magnet (89) from impacts and can be sanitized.

When the patient lies down on the mattress (1 ), a cell (10) will be closer to the magnet (89), while the cells that surround the cell in closest position to the magnet will be proximal. Each cell (10) of the mattress is equipped with the magnetic sensor (18) which is able to measure an intensity of the magnetic in the proximity of the cell, so that it is possible to create a map of the cells where the magnet (89) is disposed, indicating the cells in correspondence with a part of the body of the patient that is subject to injury. A particular algorithm calculates a decrease in the pressure (and therefore in the load) to be applied to the cells in correspondence with the magnet (89), causing the area of the patient affected by pathology to be relieved and consequently reducing the pressure of the cell (10) in contact with the area of the patient affected by the injury and the surrounding areas. The reduction of the contact pressure should favor the prevention and/or healing of decubitus damage.

Another positive factor is that the magnets (89) can be applied on the body of the patient even in the presence of the first symptoms of decubitus damage and that the magnets (89) may be more than one.

The anti-decubitus system (100) automatically adjusts the anti-decubitus support (1 ) to the position of the patient even if the patient moves autonomously in the bed. This makes it possible to produce a perfectly sanitizable anti decubitus support, without the addition of other systems used to detect the position of the patient, which are expensive, difficult to place and sanitize.

According to the anti-decubitus system (100), the mattress (1 ) can have zones that are preset at a constant pressure value in order to avoid physical damage to the patient and that are not subjected to the control processes.

Said zones are:

- an x number of rows starting from the bottom of the bed (heel area);

- a number of lines starting from the top of the bed (occipital zone), if the patient is equipped with an anti-decubitus pillow for hospitalization.

No detection and/or control action is carried out in these areas.

For illustrative purposes, if according to the physician it is advisable to relieve the heel area of a patient, it will be possible to establish a pressure lower than the typical inflation value of the cells of the mattress for this area. In this way, the legs of the patient are supported in the tibia-fibula area and therefore the heels are not at risk of injury.

The mattress tries to compensate the pressure peaks, when the patient is positioned correctly, supine and with the bed in horizontal position. Under special conditions of use, the system may not be able to compensate the peak pressures.

For example, the adjustment of the articulated bed (in 4 sections) can create areas with pressure overload that cannot be compensated by the mattress (> 32mmHg) if the inclinations are very pronounced and the load is shifted to the gluteal area.

Or, at certain times of the day or for particular functions (for example, at lunch/dinner time) the patient is seated on the bed, with his/her legs out of the bed, so that all the weight is discharged on the glutei and on part of the femoral area.

In these cases, the system abandons the pressure redistribution principle and switches to a rebalanced support of the body. Moreover, it implements an automatic massage system by alternating some occupied cells, with a pressure x% higher than the average, with other cells with an average pressure lower by the same percentage.

Such an alternating situation is changed slowly over time, in order to create a slow massage and avoid harmful pressure peaks.

The passage from the balanced mode to the massage mode can be done automatically or manually.

Such a condition occurs easily with the anti-decubitus cushion device.

In any case, the application of a magnetic indicator allows for excluding the area from the massage operations and for discharging the pressure.

The anti-decubitus systems, namely mattress and cushion, are controlled by a PC which, in addition to controlling their operation, collects and stores the data in the Cloud.

Such a data collection allows for developing research programs aimed at improving the knowledge and the treatment of these diseases.

For example, artificial intelligence systems can understand the position of the patient based on the pressure mark detected by the mattress.

Or, they can understand the relationship between the possibility of developing decubitus damage and the physical characteristics of the patient. The system according to the invention comprises an anti-decubitus support (1 ) comprising a plurality of smart cells (10). Each cell (1 ) comprises a control board (8) which is a local processor, a bubble (9) of inflatable type, a pressure sensor (11 ) and a one-way solenoid valve (19). Advantageously, the cell also includes a magnetic sensor (18).

The processor (3) communicates with the control board (8) of the individual cells through the connection bus (46) and programs the control boards (8) of the cells for operations that are performed autonomously.

The pneumatic system (S) has a distribution duct (30) that is common to all the bubbles (9) and operates in time partitions and in sequence for several functions, in order to inflate and deflate the bubbles and rebalance the pressure of the bubbles based on the pressure detected by the pressure sensor of each cell.

The processor (3) is in continuous communication with the control board (8) of each cell, through the connection bus (46) in order to instantaneously read the pressure detected by the pressure sensors in each cell and reprocess the data to be sent to each control board in order to modify the behavior of the cell.

The expressions “time partition” and “autonomous operation” of the various cells are described as follows: the patient is positioned on the anti-decubitus device (1 ) and the pressure of the bubbles is measured after positioning the patient on the anti decubitus device.

The processor (3) compares the measured pressures with preset threshold pressure values and determines that:

- some of the bubbles need to be inflated (at different pressures),

- some of the bubbles need to be deflated (at different pressures),

- some of the bubbles must be connected in order to rebalance their pressure.

Then, the processor (3) sends information to the control board (8) of each cell on the actions that are to be implemented by the control board and on the pressure to be reached by the bubble. Then, time partition 1 (Inflation) begins and the distribution duct (30) is put under pressure for inflation. The cells of the bubbles that are to be inflated open the solenoid valve and the bubble is inflated to the preset pressure. When the preset pressure is reached, the solenoid valve is closed.

Similarly, time partition 2 (Deflation) begins. When a bubble is to be deflated, the distribution duct (30) is enabled to discharge the air outside. The cells of the bubbles that are to reduce their pressure open the solenoid valve and the bubbles are deflated to the preset pressure.

Then, time partition 3 (Rebalancing) begins. The rebalancing of the pressures is accomplished by connecting the bubbles to the distribution duct, which does not allow for loading or unloading the air and only acts as intercommunication.

This system employs half the solenoid valves of the systems of the prior art and uses only one tube (distribution duct (30)) for the pneumatic connection with all the cells, unlike the system in W099/42070A1 which uses a number of connection tubes equal to the number of cells.

The use of the magnetic sensor (18) provides an active protective system against decubitus damage.

It must be considered that all systems of the prior art are limited to performing massage cycles, without any indication of the clinical status of the patient. Therefore, the systems of the prior art are based on the fact that the medical staff must identify the position of the decubitus injury and modify the support accordingly. Obviously, such a solution is not valid if the patient moves.

On the contrary, in the system according to the invention, for patients with decubitus damage, the magnet (89) is applied in the proximity of the dressing and acts as a token. When the patient sits on the anti-decubitus support (1 ), the cell closest to the magnet (89) (via the magnetic sensor (18)) will reduce the support pressure on that specific cell and on the cells of the surrounding area, deflating the corresponding bubbles. Because of this, the area of decubitus damage is automatically relieved from the support pressure.

This applies even if the patient moves on the support. The system is automatically operated if the area subject to the damage is on the support surface, otherwise the system is operated normally for rebalancing the pressures.

For example, if the patient has damage in a scapula, without the intervention of an operator or a nurse, the system will be operated if the patient is supine and will not be operated if the patient lies on her/his side.

Furthermore, being organized in slats (12), the system according to the invention facilitates the services of replacement, maintenance and repair of the devices. If a cell malfunctions, the entire slat (a 3-way electrical connector and a single tube) is replaced in an extremely simple way without tools.