Over-mattress with over-cushion that treats bedsores by restoring the arterial blood supply

Abstract

The invention that is the subject of this request is a medical device that, through a system of alternately pressurized pipes, creates a situation in which a small part of the epidermis is simultaneously affected by a micro-levitation phenomenon and by a greater influx of arterial blood. Thanks to the action of the pressurized pipes, the arterial blood, which can no longer pass through the capillaries [(7) in Fig. 6] because they are subjected to a greater pressure than before without the device, is forced to pass through the capillaries [(8) in Fig. 6] which, in turn, are as if levitated because they are no longer in contact with the support surface. Since the device works cyclically, this means that, wherever the lesion is located, it will be traversed by a greater quantity of arterial blood than that which traversed it in the previous condition.

Description

[0001] DESCRIPTION of the industrial invention entitled

[0002] “OVER-MATTRESS (WITH OVER-CUSHION) THAT TREATS BEDSORES BY RESTORING THE ARTERIAL BLOOD SUPPLY”

[0003] The present invention fits into the medical sector and more precisely into that which studies and treats pressure sores or bedsores.

[0004] As is well known, bedsores are lesions of the skin and underlying tissues, caused by the prolonged compression of a soft tissue (skin, subcutaneous tissue, muscle) between an overlying bony protrusion and an external support surface below.

[0005] This compression creates an obstacle to the normal flow of blood, therefore, the same tissues - not adequately nourished - tend to develop necrosis.

[0006] Bedsores therefore form mostly in areas where the prominences of the skeleton (sacrum, ischium, heels, nape, spine), with the participation of the solid support surface, compress the soft tissues between them.

[0007] STATE OF THE ART

[0008] At the beginning of the last century an Italian doctor recommended moving the patient no longer than two hours in the same position.

[0009] At the time it was known that a prolonged fixed posture of the patient would trigger bedsores, so it was recommended to mobilize the patient by having him, from supine, lean first on one side, then on the other, raise the legs, the torso, etc. The purpose of this technique was to prevent a bony prominence from compressing the corresponding soft tissue for a period longer than 2 hours, so that the compressed soft tissue was again supplied with arterial blood before subsequent0 compressions. In 1930, Dr. Landy was able to evaluate the average local arteriolar pressure of the skin at about 32 mmHg, so a pressure greater than 32 mmHg that acts for a sufficiently prolonged time on a portion of the skin gives rise to a bedsore.

[0010] Currently, all the “Guidelines” starting from the USA Agency (A.H.C.P.R.), followed by [Norton D., Me Laren R., Exten Smith] in “An investigation of geriatric nursing problems in hospital” in 1962, the Policlinico S. Orsola Malpighi of the Hospital Company of Bologna, the A.I.S.Le.C. in “Posture Change Guidelines” in 1995 and Patterson J.A., Bennet R.G. in “Prevention and Treatment of Bedsores” in 1995 recommend not applying a pressure higher than 32 mmHg to the skin for more than 2 hours as this would start the formation of a bedsore.

[0011] Instead, Dr. Cucinotta D. in “Pathophysiology of Bedsores” and in “Crucial Aspects in Geriatric Nursing” in 1995 recommends significantly reducing the time of application of pressure because the formation of a bedsore does not depend only on pressure. In fact, the formation of a bedsore also depends on the local thickness of the skin (thickness dependent on the age and health status of the patient), on various haemodynamic factors, on blood viscosity, on the haematocrit value, on obesity, incontinence, malnutrition etc.

[0012] All this being said, at the current state of the art there are numerous devices consisting of anti-bedsores mattresses and / or mattress toppers that perform their action following the principle of alternating pressure and that of air release in order to equally distribute the patient's weight on the same body surface and make him change posture every 2 hours.

[0013] The "alternating pressure devices" are made up of a series of interconnected pipes (or cushion zones) that, by inflating and deflating alternately, prevent the body pressure from exerting its force constantly on the same skin area by alternating the area of influence of the pipes so that the pressure on the same area is less than 2 hours. These devices try, using pressure in the pipes generally higher than 32 mmHg, to convey the arterial flow towards the bedsore in order to heal it with the supply of nutrients but, as we will demonstrate later, the pressures used are lower than those necessary to combat the bedsores and, therefore, they are unable to obtain the benefits they hope to achieve.

[0014] The “air-release devices?* are also made up of a series of interconnected pipes (or cushion zones), formed with porous fabrics that allow, in addition to the alternation of pressure due to the weight of the patient, also the passage of air from the outside towards the patient. This movement of air helps to control humidity, preventing damage from skin maceration.

[0015] There are also “fluidized air devices” with dynamic fluctuation of the air. This device consists of a bed-tub containing siliconized microspheres enclosed in an air-permeable lining and fluidized by a flow of hot air that keeps them in continuous movement.

[0016] Therefore, the body is suspended and this guarantees, in addition to an excellent distribution of body weight, continuous movement of the patient who should thus be free from bedsores.

[0017] Among the countless systems for preventing bedsores, we must take into account patent no. "US 5 010 608" of April 30, 1991 in the name of Dr. Barnett Richard (US) entitled “Support system for reducing the formation of pressure ulcers” with which he claimed the invention of a device made up of “N” series of soft and flexible pipes which, by inflating all the series except one, obtained - by inflating and deflating the series alternately - a variability of pressure on the human body with the aim of mobilizing the patient in order to reduce to a minimum the compression times of a soft tissue between a bony prominence and the underlying mattress.

[0018] In 2018, Dr. Chapin William Lawrence (US) obtained patent no. US 160821 issued on 2018 / 06 / 14 entitled “Moving wave air mattresses and method and apparatus for generating moving waves thereon” claiming the invention of a device consisting of pipes that are inflated and deflated in succession obtaining a movement similar to a sea wave with the intent of avoiding the formation of bedsores and at the same time stating that “the wave patterns can simulate water waves and / or the oscillation movements of a boat to produce relaxing effects for the patient”.

[0019] Dr. Chapin has actually invented a system that automatically arranges the continuity of inflation and deflation (as in all devices that use the alternation of pressure in the pipes that make up the mattress) trying to simulate a calm sea wave that helps the patient to relax, providing a comfortable situation since the maximum pressure acting in the pipes that form the wave is only 25 mmHg, there is however the risk that the patient suffers effects on the nervous system similar to an attack of seasickness.

[0020] In recent years, the use of traditional and advanced dressings has been joined by new treatment options for numb ulcers and difficult wounds, ranging from biological therapies to physical therapies, to new surgical techniques. The sector of "biological therapies" in particular is expanding rapidly, now a consolidated clinical reality in specialized Italian centers. Among these is "larval therapy" which involves the use of fly larvae that feed on dead or infected tissue without damaging healthy tissue; they also release bactericidal substances that stimulate the healing process.

[0021] All the devices previously described try, in various ways, to distribute the patient's weight equally over the entire body surface in order to reduce the pressure between a bony prominence and the corresponding soft tissue and, with the alternating pressures, tiy to optimize the advice given more than a century ago by an Italian doctor.

[0022] Therefore, today's idea - and the one more than a century old - is and was that of not having constant pressure on parts of the patient's body for a prolonged time. Much has been done in the treatment of bedsores, consequently improving the quality of life of patients.

[0023] Unfortunately, to date, nothing or almost nothing has changed, in fact the Agency for Health Care Policy and Research (A.H.C.P.R.) after reviewing over 300 texts, 45,000 reports and 1,700 documents concluded that after their guidelines, published in 1992, the scientific evidence - to date - has not undergone substantial changes.

[0024] In fact, to date there is no device - nor even a scientific method - that prevents bedsores or cures them by regressing the bedsore until it disappears.

[0025] PROBLEM TO BE SOLVED

[0026] The cause of the onset of bedsores is the occlusion of the capillaries due to crushing due to the effect of the patient's own weight lying on a support support. The surface on which the patient is lying contributes to compressing the capillaries that are found in the soft tissue compressed between a bony protrusion and the supporting surface of the patient: this is the cause that hinders the normal flow of arterial blood that is no longer able to feed the cells with nutrients, thus giving rise to a bedsore.

[0027] Therefore, to avoid the lesion, the patient should levitate in the atmosphere without having a solid structure underneath him so that the patient's own weight does not occlude the capillaries... which is unachievable !!!

[0028] DESCRIPTION OF THE DRAWINGS

[0029] In these drawings and in the figures the following is schematically represented:

[0030] Fig. 1 the over-mattress device, made up of pipes (2), a fluid distribution manifold (3), both placed on the mattress (1) and a box that contains all the control elements (4). The orthogonal section line of the device is indicated there with the expression (Z - Z).

[0031] Fig. 2 the intercalary arrangement in succession of the individual pipes, belonging to the different series, indicated with the first number 2 the generic pipe (pipes in Fig.l), the second number 1 (or 2, or 3) to indicate the series to which they belong, the third number 1 (following 2-3-4-S) to indicate the progressive number of pipes belonging to the same series.

[0032] The same figure schematically represents the arrangement of the pipes (31-32-33) of the collector for the distribution of the fluid inside the pipes forming the over-mattress

[0033] Fig. 3 the first phase of the cycle [case of a device consisting of 3 series of pipes, section view Z-Z (in Fig. 1)] and where (la) and (2a) indicate the first and second series of pressurized pipes, with (3a) the third depressurized series; with (a) the pressurized pipes, with (b) the depressurized pipes; with (g) the sheath containing the pipes;

[0034] Fig. 4 the second phase of the cycle, where series (la) is depressurized while series (2 a) and (3a) are pressurized;

[0035] Fig. 5 the third phase of the cycle where series (la) and (3a) are pressurized while series (2a) is depressurized;

[0036] Fig. 6 highlights both the status of the capillaries (7) ‘‘compressed’ by the combined pressures [body (5) and that (6) of the pressurized pipes (a)] and the status of the “free” capillaries (8) i.e. subjected only to body pressure (5). The same figure highlights the distance “d” between the mattress and the epidermis “c” as well as the distance “e” between two non-contiguous pressurized pipes “a”. It should be noted that the dimensions of the capillaries (in the drawing) are not proportional to the dimensions of the other elements.

[0037] Fig.7,8,9 represents the status of the “hee? (ta) when it is positioned above pipes with a diameter of 16 mm [a’ in (Fig. 7)], with a diameter of 20 mm [a” in (Fig. 8)] and with a diameter of 40 mm [ a”’ in (Fig. 9)].

[0038] SYMBOLS USED IN THIS DESCRIPTION

[0039] Hereinafter we indicate with:

[0040] • BS -> the bedsore (LdD in Italian version);

[0041] • (1) -> [Fig.l] the mattress;

[0042] • (2) -> [Fig.1] the over-mattress made of pipes;

[0043] • (n) -> number of series of pipes forming the over-mattress;

[0044] • (Φ) the diameter of the pipes [Fig.6];

[0045] • (a) -> [Fig. 6] the pressurized pipes;

[0046] • (b) [Fig. 6] the zero internal pressure pipes;

[0047] • (c) [Fig. 6] the line of demarcation of the epidermis;

[0048] •(d) -> [Fig. 6] the distance between the epidermis (c) and the mattress (1);

[0049] • (e) -> [Fig. 6] the distance between two non-contiguous pressurized pipes (a);

[0050] •(op) -> [in Fig. 6 indicated as (5)] the pressure uniformly distributed on the patient's body and deriving from his own weight;

[0051] • (T) -> [in Fig. 6 indicated as (6)] the pressurization value of the pipes;

[0052] • (7) [Fig. 6] the position of the capillaries subjected to both pressure (op) and pressure (T) which we will define as "compressed* capillaries;

[0053] • (8) [Fig. 6] the position of the capillaries subjected only to pressure (op) due to the patient's own weight and which we will define as "free",*

[0054] • (ψ)=(CT?+ T) the combined pressure [sum of pressure (op) and pressure (T)[ weighing on the capillaries and due to the double action of the patient's own weight and the pressure caused by the device;

[0055] • (ψR) = kψ -> value transmitted from (ψ) to the free capillaries in (8) position which are subjected only to the pressure (σP);

[0056] • (k) -> reduction coefficient;

[0057] • (tv) -> the time of application of pressure (vp) [identical to the time of application (tT) of pressure (T)] during a phase of the cycle;

[0058] • (Tcycie) the time duration of an entire operating cycle;

[0059] • (β) the occlusion pressure on the capillaries compressed between a bony prominence and the underlying mattress in normal conditions, that is, without the application of the device;

[0060] • (βR)=70% (P)-> the residual occlusion pressure on the “free? capillaries which are in position (8) [Fig. 6] when the patient is subjected to the action of the device;

[0061] • (ta) -> [Fig. 7] the average width of a heel;

[0062] • (A) = [(n— 1) x tψ] represents the total pressurization time of “a single series of pipes during a complete operating cycle” of the device.

[0063] THE "RATIO" BEHIND THE INVENTION

[0064] It is unfortunately true that “without the elimination of local pressure, any other preventive and therapeutic measure is useless” [Beltracchi V., Calosso A., Marieschi M., A.I.S.Le.C. in 1996]: the patient should therefore be levitated to cure or prevent BS.

[0065] To try to solve the problem, think of a river that branches out in three directions, distributing its flow among them. If you imagine closing 2 branches, the total flow of the river must necessarily flow through the branch that remained open.

[0066] If you further think an obstacle within the only open branch, the flow will overcome the obstacle only if it has sufficient power, otherwise the flow will also be hindered in the only open branch. Returning to the problem of the BS, if - by applying various techniques - we manage to hinder the arterial flow in some capillaries (those defined as "compressed*) to force that same amount of blood flow - "hindered from flowing in the compressed capillaries" - to supply the BS when it is in position (8) [Fig. 6], therefore with the capillaries "free" ... we would have solved the problem, provided that the arterial flow has sufficient thrust to overcome the obstacle represented by the residual occlusion pressure (βR).

[0067] PRACTICAL CONSEQUENCES OF THE INVENTION

[0068] As an application to obtain a positive result we thought of an overmattress [Fig. 1] made up of a series of soft and flexible pipes to be pressurized and depressurized cyclically, so that the BS present on the patient's body surface in contact with the device, will be - wherever it is - stimulated by the action of the device.

[0069] Therefore, it will be necessary to find the value of the pressurization pressure (T) of the pipes which, together with the body pressure (op), will form the pressure (ψ)=[(T)+(CTP)] capable of obstructing the blood flow in some capillaries so that, this rejected flow, is forced to direct itself towards those capillaries not subjected to pressure (vp) but only to body pressure (σp). Since the action of the device is cyclical, it is evident that, when the BS is in (8) position [in Fig. 6], the affected capillaries will receive a greater influx of arterial blood which, with its nutrients, will be able to defeat the BS.

[0070] Moving on to examine the different values, we have that:

[0071] 1. the pressure (ψ), to be exerted on the capillaries in position (7) that are intended to be compressed, must be evaluated in order to avoid the possibility of triggering a new BS due to the excessive value of the (ψ) pressure;

[0072] 2. the application time (tψ), of the afore mentioned pressure (vp), must also be evaluated, because the onset of a new BS also depends on the application time of the pressure;

[0073] 3. since the pipes constituting the device follow a pressurization and depressurization cycle, we will have that the capillaries that flow into the BS in contact with the device will be found, cyclically, in position (7) and in position (8), both highlighted in Fig. 6;

[0074] 4. the BS originates due to the occlusion pressure (β) which is evaluated between 120 and 170 mmHg \Redfem S. et al. in “Local pressures with ten types of patient support system”, Lancet in 1973] and [Molinelli S. in “ Bedsores”, in 2007]. We indicate with (0R) the residual occlusion pressure that occurs in the same occluded capillaries (present in the BS) when from position (7) [Fig. 6], thanks to the action of our device, they come to position (8) [Fig. 6], that is, when they are subjected only to body pressure (op) without having any contact with the underlying mattress;

[0075] 5. similarly, the residual value (ψR) of the pressure (i| / J must be evaluated, which is transmitted, from those capillaries [in position (7) Fig. 6] deliberately obstructed by the device, to arterial blood flow that will pass through the obstructed (but “free”) capillaries, inside the BS, when they are in position (8) Fig. 6;

[0076] 6. once the values of (0R) and (VJ / R) have been obtained, it will be necessary to verify that they are:

[0077] (ψR) > (βR) otherwise the action of the pressurized pipes will be completely irrelevant.

[0078] With these premises we thought of transforming the above0 theoretical reasoning into a medical device. EXAMINATION OF A HISTORICAL ASSUMPTION AND ITS CONSEQUENCES

[0079] The assumption in question is the following:

[0080] “a pressure of 32 mmHg acting for more than 2 hours on the same body portion is enough for the onset of a bedsore* [Landy, in 1930]

[0081] We know that the blood pressure inside the capillaries is 32 mmHg so it is understandable how an external pressure of only 32 mmHg, even if equal but lasting over time [because tissue hypoperfusion is tolerated only for a short period of time (A.I.S.Le.C. 1996)] negatively affects blood transit inside the capillaries.

[0082] The BS inevitably appears, therefore, when the threshold determined by the product of the pressure and the application time is exceeded, that is, the value of what we will call the “total amount of pressure Qpt” equal to

[0083] (1) Qpt = P x T [mmHg x 1’ ] = 3.840 mmHg x 1’ where:

[0084] • P is the reference pressure set at 32 mmHg;

[0085] • T is the expected maximum application time of said pressure P equal to 2 hours, expressed in minutes;

[0086] • Qpt is the total amount of pressure P that the epidermis receives for the entire time of application of said pressure P;

[0087] • 3,840 mmHg is the total amount of pressure that is delivered in a single minute; exceeding the indicated value means having the certainty that the green light will be given to the onset of a new BS.

[0088] The formula above is strictly empirical, so stated “it is not applicable*: in reality a pressure of 3,840 mmHg is not humanly bearable and furthermore it is not real that capillaries - deprived of nutrients for just one minute - can induce a new BS, but this equality becomes fundamental for subsequent developments.

[0089] Below we will use, as a theoretical upper limit in order to avoid the onset of new BS, the following inequality

[0090] (2) where

[0091] • “x” is the pressure of the pressurized pipes;

[0092] • “op” is the pressure determined by the patient's own weight and uniformly distributed on the body area affected by the BS;

[0093] “X” is the application time of the pressure ψ = (r+σp) delivered by a single series of pressurized pipes during an entire operating cycle of the device.

[0094] This relationship, connecting the pressure (ψ) = [(T)+(σP)] with its application time X, indicates the maximum amount of pressure that each single series of pressurized pipes must not exceed during each complete operating cycle.

[0095] DETAILED DESCRIPTION OF THE INVENTION

[0096] To obtain the expected results described previously in the chapter “The ratio behind the invention” we created an over-mattress [Fig. 1] made up of “n” series of soft and flexible pipes, arranged adjacent and along the length of the mattress to form a single, uninterrupted surface that completely covers the underlying mattress.

[0097] The pipes are then inserted inside a fireproof sheath, washable and sterilizable at 90°C to ensure hygiene. The pipes can have a diameter ranging from Φ 20 mm to Φ 40 mm (we will demonstrate the reason for these measures later), but, in the same device, they will all have the same size.

[0098] In addition to the over-mattress, there will also be an over-cushion made with pipes of the same diameter as the over-mattress pipes but arranged along the width of the mattress, therefore at 90° to the orientation of the pipes forming the over-mattress. These will also be incorporated inside a sheath to ensure hygiene and will be connected to the fluid distribution system by means of small silicone pipes connected via the necessary fittings.

[0099] The cyclic pressurization of the pipes will take place by means of a compressor that will push the fluid (liquid or gaseous) through a distribution system [Fig. 2] that connects all the pipes.

[0100] The system will be managed by an electronic board that will control, through special solenoid valves, the various pressurization and depressurization actions; the maximum pressure value (T) to be given to the pipes will be controlled by a pressure switch (which will check that the pressure does not exceed the pre-set value) and visually monitored by a pressure gauge.

[0101] All the pipes will be divided into several series so as to have, at every moment, only one series depressurized while all the others will be pressurized.

[0102] Figs. 3, 4 and 5 highlight the pressurization phases of the series during a cycle:

[0103] 1) in the phase explained in Fig. 3 we have the first and second series pressurized while the third series is depressurized;

[0104] 2) similarly, in Fig. 4 the second and third series are pressurized while the first is depressurized;

[0105] 3) finally in Fig. 5 the first and third are pressurized while the second series is depressurized; from this it can be deduced that the time duration of the pressure (ψ) during a cycle [composed of 3 phases, which corresponds to the number of series of pipes] is equal to 2 times the time duration of each phase.

[0106] Defining with (tψ) the time duration of a phase of the cycle, that of a complete operating cycle for a device formed by (n) series of pipes is: (3) while the actual duration of the pressure action of ( ψ) on the capillaries [which are located in correspondence with a series of pipes] during an entire operating cycle is

[0107] (4)

[0108] To evaluate the patient's body pressure (op) we must use the B.S.A. (Body Surface Area) formula [Dubois D., Dubois E.F., Arch. Intern. Med. 1916] with which the entire area of the patient's body surface is determined by referring to his height and weight according to the formula set out below

[0109] (5) where:

[0110] 1. “h” is the height in centimeters;

[0111] 2. “p” is the weight in kilograms;

[0112] 3. result expressed in square meters.

[0113] Therefore, knowing the B.S.A. and dividing it by 2, we obtain the dorsal surface of the patient in the supine position on the mattress and, therefore, the affected capillaries (with the patient in the supine position) will undergo a “uniformly distributed op pressure” of:

[0114] (6)

[0115] [pressure indicated with the number 5 in Fig. 6].

[0116] The above is to highlight how not only the weight but also the height of the patient influences to determine the uniformly distributed pressure due to the patient's own weight.

[0117] However, it should be noted that the average pressure on the compressed tissues (and therefore on the capillaries present therein) between the bony protrusions and the underlying support surface varies between 120 and 170 mmHg \Redfem S. et al. in “Local pressures with ten types of patients support system”, Lancet in 1973]; while elsewhere \Molinelli S. in “Bedsore^1, in 2007] indicates the maximum pressure value on the sacrum, in the supine position, equal to 150 mmHg. The average of the values reported by “Redfern” does not differ much from the value indicated by “Molinelli,m so we take this last value as a basis and reference for subsequent developments.

[0118] Let's check below how our device should act when a BS on the pelvis needs to be cured.

[0119] Let's start by establishing that the occlusion pressure of the capillaries present in the pelvis is β = 150 mmHg.

[0120] Let's now move on to evaluate the other values we need, namely CTP, T, ψ, βR,ψR, tψ and the diameter Φ of the pipes to be used.

[0121] To evaluate the ap uniformly distributed on the pelvis we must apply the "rule of 9' [Wallace in the "Lancet" magazine in 1951] which is used, in the case of burn patients, to determine the burned surface area. From this table it appears that the pelvis represents 18% of the entire body surface (divided equally between the anterior and posterior parts) and the pelvic area, alone, represents 1%.

[0122] So 9% of the body surface represents the entire posterior area of the pelvis but, of this entire surface, a part, equal to the area of the buttocks [which are valued at 2.5% / each] will come into direct contact with the mattress: therefore the actual surface area of the pelvis in contact with the mattress will be

[0123] Pelvis = 5% of the body surface.

[0124] Similarly, the “rule of 9" is also used to evaluate the “weight1of the various body parts, specifically the pelvis is valued at 18% of the patient’s entire weight, so the pressure (op) uniformly distributed on the pelvis and determined by the patient’s predicted values will be: from which the value of (op) is easily obtained, that is, the local pressure exerted by the patient’s weight on the contact surface of the pelvis with the mattress.

[0125] Now we need to find the value of the residual occlusion pressure (βR) that occurs when the patient is positioned on the device and the BS is located in correspondence with the area (e) between "two pressurized pipes [(a) Fig. 6] but not contiguous". It is clear that in this position, as there is no contrast with the underlying mattress, the occlusion pressure will be lower than that existing when the BS was compressed between the patient's own weight and the contrast with the mattress. In theory, the pressure should vanish since we would find ourselves in a situation of a levitating body. But certainty, in practice, this does not happen !!!

[0126] Meantime, it is important to consider the fact that the diameter of the pipes (never greater than 40 mm, we will explain why later) on one hand helps to prevent contact with the underlying mattress due to their small size, but on the other hand the two non-contiguous pressurized pipes exert an action similar to that of a sheet held taut by a series of men to receive another man who falls from a prohibitive height, so the epidermis will take on a configuration similar to that shown with the letter (c) [Fig. 6].

[0127] It is also known to obtain aorta dilation of 30 mm , a pressure of 750 mmHg must be applied \Interdepartrnental Research Center "E. Piaggio", Faculty of Engineering in Pisa].

[0128] In the case in question, the part of the epidermis present between two non-contiguous pressurized pipes, without contact with the underlying mattress, is:

[0129] 1- subjected only to body pressure which, on average, will never be higher than 10 mmHg,

[0130] 2- the deformability of the epidermis is far greater than that of the aorta and, considering an empirical ratio of 1 to 5 between the stiffness of the aorta and that of the epidermis, we should apply a pressure equal to 150 mmHg [= 750 mmHg divided by 5] on the surface of the epidermis to obtain the same deviation of 30 mm recorded in the aorta, a deviation that would cause the patient to come into contact with the underlying mattress; 3- to obtain a uniformly distributed pressure of 150 mmHg we should have a patient weighing 225 kg but with a B.S.A. < 1.50 m2and this is clearly outside the norm!

[0131] From what has just been stated, it can be deduced that the part of the patient's epidermis located between two pressurized, but not contiguous, pipes, enjoys a situation of "temporary micro-levitation" since there can never be contact with the underlying mattress but, on the other hand, the epidermis is tense due to the action of the two lateral pressurized pipes and this is comparable, albeit live but always, to contact with the underlying mattress.

[0132] Therefore, the residual occlusion pressure (βR) cannot be zero as it would be in the case of actual levitation, but it will certainly be lower than the value of the occlusion pressure (P).

[0133] Since it is not possible to evaluate the pressure drop resulting from the fact that the BS is active, we consider that the pressure (βR) is equal to 60÷70% of the initial value of the occlusion pressure (P), for which we choose the equality:

[0134] In practice the value will fluctuate between 90 and 105 mmHg, we choose to use as the value below:

[0135] Now we must find the value of the combined pressure (ψ) that can counteract the residual occlusion pressure (βR) and therefore allow the arterial flow to supply the capillaries, present in the BS, with the nutrients necessary to defeat the same BS.

[0136] The capillaries present in the position indicated with the number (7) [Fig. 6] will be subjected, by the action of the device, to the combined pressure (ψ) and the result will be to counteract the normal flow of arterial blood, so this hindered flow will necessarily have to find another path which can only be the one indicated by the area (e) between two pressurized but noncontiguous pipes (a) [Fig. 6] occupied by the capillaries present in the position indicated with the number (8) [Fig. 6] which we have defined as “free [i.e. free from the presence of both pressure (T) and contact with the mattress, therefore subjected only to pressure (op) in the quasi-levitation condition).

[0137] The arterial flow thus directed towards the capillaries located in position (8) [Fig. 6] will reach them with a lower pressure than that existing in the capillaries in position (7) [Fig. 6] due to a natural pressure drop.

[0138] We evaluate this residual pressure (ψR) as equal to: where we indicate with “k” a reduction coefficient that we estimate to be equal to where ( Φ ) indicates the diameter of the pipes expressed in millimeters.

[0139] Since we have considered that the occlusion pressure in the capillaries - that are part of the BS previously “compressed ” and now “free?* - is equal to (βR) = 100 mmHg, the pressure (ψR) must necessarily be greater them this value to allow the nutrients to reach the BS [let's remember the case of the river that, if even in the only open branch there is an obstacle and the pressure of the river cannot overcome it, the river water will have to find another alternative path to all the branches). To be sure that the device can effectively carry out its action, we evaluate this increase to be equal to 50%, therefore we will have the following inequality from which the value of the pressurization pressure (T) of the pipes is obtained

[0140] It is now necessary to evaluate the size of the pipes. Let us take on as a reference the average size of a heel that we consider equal to 45 millimeters. This reference is substantial, in fact examining what is described in Figs. (7) and (8) it can be noted how a Φ 20 mm pipe is able to divide the heel (ta) in order to make the device efficient. Instead in Fig. (9) it can be noted how a Φ 40 mm pipe occupies almost all the space inherent to the heel preventing the device from carrying out its action: therefore we conclude that the maximum diameter of the pipes suitable for our device cannot have a diameter greater than 40 mm.

[0141] Likewise, the minimum diameter of the pipes must not be less than 20 mm because otherwise the two sizes (d) and (e) [Fig. 6] would be so small as to limit the expansion of the "free" capillaries (8) and therefore would contrast the functionality of the device.

[0142] Of course, the device will perform its functions even if pipes with a diameter greater than 40 mm are used, but it would not be able to intervene on the lesions present in the heels and elbows.

[0143] In everyday practice, the use of a pipe with an external diameter of 30 mm is recommended.

[0144] It now remains to evaluate the time of a phase of the combined pressure application cycle (ψ) [time equal to that of the pressure (T)] referring to expression (1) on page 11

[0145] Qpt = P x T = 3.840 mmHg x 1’.

[0146] Let us consider a device made up of “n” series of pipes that are - always and at every instant - with all the sets pressurized and only one (not always the same) at zero pressure [Figs. 3,4,5].

[0147] It is therefore necessary to evaluate the amount of pressure that the device supplies to the patient, with its pressurized pipes, and compare it to the maximum amount of pressure allowed Qpt.

[0148] The value of the amount of pressure expressed by each single series of pipes of the device during an operating cycle will be

[0149] (14) with ψ = (T + σp), with Tcycie = n x tT, with n = number of pipes series composing the device, with tT= time duration of a pressurization phase, based on what is described above, it must be

[0150] (15) it is therefore easy to obtain the time duration value tT(which is identical to the value of tv) to be given to each, phase of pressurization of the pipes

[0151] (16)

[0152] Remembering that Dr. Cucinotta D. in “Physiopathology of bedsores" and with “Crucial aspects in geriatric nursing" in 1995 recommends taking into account that the formation of a bedsore does not depend solely on pressure but also on a combination of other factors, we consider applying the expression (1) above with the necessary variations, decreasing the maximum values, relating them to the clinical conditions of the patient as specified below:

[0153] > reduced by 70% in the case of patients with B.S.A. > 1.50 m2:

[0154] Q°pt = 30% Qpt < (0.3 x 3.840) = 1.152 mmHg x 1’;

[0155] > in the case of patients with B.S.A. < 1.50 m2, so extremely fragile patients, it is necessary to further decrease, up to 80%, the total amount of pressure which will result:

[0156] Q°°pt = 20% Qpt < (0.2 x 3.840) = 768 mmHg x 1’

[0157] Therefore, in conclusion, in the practical application of the device the underlying inequalities must be taken into account:

[0158] (17)

[0159] (18) It should be noted that, with the increase in pipe series, the area in which the capillaries are located in correspondence with the nonpressurized pipes, - at the same pressure ψ , of the same cycle time (Tcycie) and net of natural pressure drop - will be traversed by a greater amount of arterial blood. In fact, in the case of 3 series, there is a ratio of 2 to 1 because the “hindered* arterial blood - which travels through the area corresponding to that where the non-pressurized pipes act - comes from a double surface area; in the case of 4 series of pipes, this ratio becomes 3 to 1, and so on by increasing the number of series. The advantage of having more series of pipes is evident because by increasing the quantity of arterial blood forced to travel through the capillaries inherent to the BS, there is a greater supply of nutrients and therefore a quicker healing; but this does not exclude the possibility of using the device with only 2 series of pipes, for which only one pressurized and one the other not, the device will still perform its action.

[0160] As a final consideration, it must be kept in mind that "the application of low pressure for a prolonged period of time is more harmful than the application of high pressure for a short period", a finding verified by Dr. Zanetti [Zanetti E. "Physiopathology of bedsores", in 1996].

[0161] This last observation must be taken into great consideration because formulas (17) and (18) provide us with 2 interconnected data, the pressure and its application time, therefore it is up to the operator to evaluate, based on the general conditions of the patient, whether to increase the pressure at the expense of the application time or vice versa, always respecting the maximum values indicated by inequalities (17) and (18).

[0162] Let's now see what the minimum pressure to be given to the pipes should be so that it can perform the required function. From [Redfern S. et al. in “ Local pressures with ten types of patient support system”, Lancet in 1973, page 10], we know that the A of the blood pressure values is between 120 and 170 mmHg.

[0163] Therefore, in the case of the minimum occlusion pressure of 120 mmHg acting on the capillaries compressed between a bony protrusion and the underlying mattress without the presence of our device, this, thanks to the device, will become, when it is in position (8) [Fig. 6]: βR= 70% x 120 mmHg = 84 mmHg and therefore the pressure ψR, capable of overcoming this barrier, must have a value of ψR = ( 84 mmHg x 1.5 ) = 126 mmHg.

[0164] This value indicates the incontrovertible fact that, thanks to the micro-levitation effect, the pressure to be applied to the pipes is far lower (and therefore more acceptable to patients) than what would be necessary to defeat the BS without our device.

[0165] This is the minimum value that the pressure (ψR) must reach in order for the device to be able to start supplying nutrients to the less invasive lesions. Below this value, positive results cannot be obtained, a lower pressure will be completely irrelevant for the eventual healing of the BS.

[0166] Therefore, generalizing, we can write that the value of the pressure (ψR) that the device must supply, in relation to the residual occlusion pressure (βR), must always respect the following inequality:

[0167] (19)

[0168] This is the condition that the residual combined pressure (ψR) will have to respect in order to be sure that the hindered capillaries of the BS will receive those essential nutrients to be able to eradicate the BS, a lower pressure will be completely irrelevant.

[0169] In conclusion, knowing the weight and height of the patient and, thanks to the expressions reported above, we are sure that the arterial blood will be able to counteract the occlusion pressure (βR) by providing the BS with all those nutrients that will be able to make the BS regress to until it completely disappears.

[0170] To achieve this, the device must achieve, SIMULTANEOUSLY, the following 4 conditions:

[0171] 1st condition: the values indicated in the two following inequalities must be respected

[0172] (17)

[0173] (18)

[0174] 2nd condition:

[0175] This inequality must be verified

[0176] 3rd condition: the pipes, constituting the device, must have a diameter (<D) between

[0177] 4th condition: the pipes, constituting the device, must be formed, preferably, with a serial number (n) of pipes not less than 3, so

[0178] In fact:

[0179] > by respecting the “1st condition” we are certain that a new BS cannot be created;

[0180] > by respecting the “2nd condition” we will be certain that the device will be able to send arterial blood with the right pressure to defeat the residual pressure (βR) insisting on the BS;

[0181] > by respecting the “3rd condition” we will be certain that the device will perform its functions because:

[0182] 1) with diameters > 40 mm the epidermis (especially in elderly and debilitated subjects) will come into contact with the mattress canceling the micro-levitation in addition to not being able to influence the BS present on the heels and elbows;

[0183] 2) with diameters < 20 mm the two sizes (d) and (e) [Fig. 6[ would be so small as to create difficulties for the “free” capillaries (8) [Fig. 6] to expand to facilitate the functionality of the device;

[0184] > by respecting the “4th condition” we will be sure that the device will be able to send a flow of arterial blood in such quantity as to supply the BS with the necessary and sufficient nutrients.

[0185] Of course the device must be - always - supported by all the nursing and clinical measures aimed at keeping the BS clean and not purulent.

[0186] DETAILED DESCRIPTION OF AN EMBODIMENT

[0187] In an exemplary embodiment of the present invention, concerning the over-mattress device, let us assume that pipes with an external diameter of 30 millimeters are used.

[0188] Therefore, it will be necessary to use no. 30 pipes to cover the entire width of the mattress; the length of each pipe must be 180 centimeters so that the collector (3) [Fig. 1] has space to be placed under the cushion.

[0189] As a first step, it is necessary to decide the type of fluid to use for the pressurizing the pipes. It is preferable to use air rather than a liquid fluid because the following advantages are obtained: a) in hospital resuscitation departments it is not possible to use liquid fluids in the pipes; b) it is lighter (therefore more maneuverable) than liquid fluids; c) it does not require a container to receive the fluid in the depressurization phase, the air can be discharged into the environment; d) the air can be heated in the same way as the liquid fluid.

[0190] The equipment needed for the device to function, such as the compressor, the pressure switch, the pressure gauge (visible from the outside of the container box), the electronic control board for all operations, the electrical cut-out safety switch and all other components needed for the device to function properly, will be placed inside a container (4) [Fig.1] located at the footboard of the bed.

[0191] To heat the fluid, a cartridge heater must be inserted into the pipes in each set, while maintaining the temperature of the heaters below 20°C; higher temperatures would cause exudation and therefore skin maceration.

[0192] If, however, the device is used in the intensive care unit and the patient is also with hypothermia problems, the heaters must be able to reach a temperature of 40°C; the combined effect of the thermal blankets and the heating device would help overcome the problem.

[0193] The series of pipes in the over-cushion will be connected to the pipes in the over-mattress using standard quick couplings; these sets will also be controlled by the equipment inside the container located at the footboard of the bed.

[0194] From what has been described above and so far, it can be said that for a technician in the sector there cannot be significant obstacles for the creation of the device, including the command and control system.

[0195] HOW TO CALCULATE THE VALUES

[0196] TO ATTRIBUTE TO THE DEVICE IN RELATION

[0197] TO THE PATIENTS CHARACTERISTICS

[0198] 1 ) over-mattress

[0199] Let's consider a patient with 165 cm height , 62 kg weight and 3 pipes series with diameter Φ 30 mm: therefore using the formula (5) we are able to calculate the value of his B.S.A. = 1.68 m2.

[0200] Therefore we will use the expression (17) Q°pt < 1,150 mmHg x 1' minute.

[0201] Let's consider that the BS is located in the pelvis area and, thus, using the "NINE” formula, we will have that the pressure (CTP) uniformly distributed on the pelvis will be: the coefficient k of the expression (10) k = (1 - 0.2% Φ) will be : k = 0.94 and having decided to assume, as residual pressure on the pelvis, when the BS is in position (8) [Fig. 6], the value equal to

[0202] PR = 100 mmHg, we will have ψR = 0.94 ψ = 1.5 PR = 150 mmHg , from which we get ψ = 159.57 mmHg, so we can calculate the pressurization value T of the pipes: r = ψ - CTP = ( 159.57 - 9.78 ) = 149.79 mmHg to be applied for a time [using the expressions (15) and (16)] and from expression (3) we get:

[0203] So we have derived both the value of pressurization to be given to pipes

[0204] T = 150 mmHg and its application time tT= 3’ 36” (three minutes and thirty-six seconds).

[0205] We have, thus, derived all the elements needed to make the device work positively.

[0206] 2) over-cushion

[0207] With the same “rule of 9* we know that the surface of the head and neck of an individual is equal to 9%. Therefore, we consider that the surface of the head in contact with the cushion is equal to 3% of the body surface of the head in contact with the cushion is equal to 3% of the body surface evaluated with the BSA method, in the case in question we will have that the surface of the head that will come, into contact with our device, will be:

[0208] 1.68 m2x 3 % = 0.0504 m2= 504 cm2; similarly the weight of the head and neck, equal to 9% of the body weight is:

[0209] 62 kg x 9 % = 5.58 kg;

[0210] Therefore, the local pressure, uniformly distributed and due to the patient's own weight, weighing on the capillaries affected by the head is: value not dissimilar to the value found on the buttocks, therefore a single previously calculated pressure (T) value is applied to the device, so the pipes present in the over-cushion will act with methods identical to those valid for the pipes present in the over-mattress.

[0211] From the calculations highlighted above, it appears that for any patient the value of the pressure (T) and the value of its application time (tT) to be used is practically identical for both the over-mattress and the over-cushion.

[0212] From what has been described above, it can be seen that the device is easily adaptable to any type of patient with any type of lesion: the micro-levitation of small parts of the body, being continuous, substantially affects the entire body surface in contact with the pipes that replace the mattress; in practice, the continuous micro-levitation means that the arterial flow cannot fail to - cyclically - supply the entire body surface affected by the action of the device. INDUSTRIALIZATION OF THE DEVICE

[0213] The industrialization of the device that is the subject of this patent application is objectively necessary because to date there are no cures for BS that can reverse BS and prevent its recurrence. It is also known that the world population tends to live longer and longer, thanks to medical developments, but this leads to more and more people subject to BS and, in practice, these only occur in elderly people with the sole exception of young people who have suffered trauma that forces them to not be able to move independently. Therefore, the global numbers are immense and we cannot think of an industrialization of the only (for now) device capable of regressing the BS and preventing its recurrence.

[0214] In Italy alone, statistics from the 2010s, there were approximately 2 million people affected by BS and this number increased by approximately 8% each year.

[0215] The industrialization of the device can be implemented by using:

[0216] > a mold that will provide, in a single piece, all the pipes needed for both the over-mattress and the over-cushion;

[0217] > a mold will also be used to have, in a single piece, the fluid distribution manifold;

[0218] > all other components are easy to find on the market and in constant production, so there are no obstacles to the creation of the container box with all the components needed for the operability of the device.

[0219] D IFFEREN CE S

[0220] OF OUR DEVICE WITH OTHER DEVICES

[0221] All the anti-bedsores devices currently on the market base their " ratio” on three fundamental principles to be respected which are:

[0222] 1. DISTRIBUTE, the patient's own weight over the maximum0 possible body surface, trying to avoid critical load points such as the shoulder blades, buttocks etc. ;

[0223] 2. AVOID, having one area of the patient's body in the same posture for more than two hours;

[0224] 3. MASSAGE, through alternating pressure systems, the patient with the intent of increasing the amount of blood flow in the hope that this greater amount will supply the BS.

[0225] However, with current systems, the patient will always be in contact with the support surface as the components of the known devices (pipes or sectors) are far greater than the limit of 40 mm and, since the pressure that the known devices are able to dispensing is almost always lower than the value indicated by the expression (19), these systems are unable to prevent and treat the BS. Referring to the example of the river with two closed branches and one open, we have considered that the only open branch, which still presents an occlusion, will have to be crossed by a flow with a pressure (ψR) not lower than 1.5 times the occlusion pressure (βR) in order to get positive results: no one to date has evaluated this “conditio sine qua” positive results will never be achieved

[0226] Moreover (as stated on page 5) the Agency for Health Care Policy and Research (A.H.C.P.R.) after having reviewed over 300 texts, 45,000 reports and 1,700 documents concluded that "after their guidelines, published in 1992, the scientific evidence - to date - has not undergone substantial changes".

[0227] The “ratio” of our finding differentiates it from all the others for the following reasons:

[0228] > the currently known devices do not consider our “INEQUALITIES (17) and (18)” (to estimate pressures and delivery times), which entails the risk of generating other BS instead of taking care the existing ones;

[0229] > none of the currently known devices refers to the “B.S.A.” value which characterizes the patient [all other devices consider patients physically equal to each other] and from which the study must begin to calculate the values to be applied to each individual patient: in fact, a patient who weighs 40 kg and is 150 cm tall, with B.S.A. - 1.29 m2, will have a uniformly distributed pressure on the buttocks of 8.16 mmHg, while a patient weighing 100 kg and 180 cm tall, with B.S.A. = 2.23 m2, will have a pressure on the buttocks of 11.67 mmHg, consequently the value to be attributed to the pressure of the pipes varies, but - more importantly - the “maximum value of the amount of pressure?* to be attributed to the series of device pipes varies in relation to the patient’s B.S.A., by applying of our formulas (17) and (18);

[0230] > the majority of currently known devices have no possibility of intervening on the BS present in the “HEELS and ELBOWS’, given the enormous size of their pipes and sectors that will never be able to divide the afore mentioned BS; while some current devices that have pipes or sectors capable to divide the area of the heels and elbows are unable to be proactive due to the inefficiency of the pressures they use;

[0231] > finally, a substantial difference is that no known device provides for “A DELIBERATELY PRESSURE ACTION” [calculated on the patient’s own BSA value] on the capillaries in position (7) [Fig. 6] compressed between the patient’s own weight and the pressurized pipes aimed at obstructing the regular arterial blood flow so as TO FORCE the same hindered flow to supply the BS. In fact, so that the arterial flow can pass through the space, indicated by the letter (e) [Fig. 6] with a pressure “ψR” such as to counteract the residual occlusion pressure “(3R” (residual thanks to the micro levitation) it will be necessary to find the value of the pressure “r” to be given to the pipes, which can be done using our expression no. (13);

[0232] > since the alternation of pressures is cyclical, the BS - wherever it is, as long as it is in contact with the device - will be reached and supplied by arterial blood flow; > none of the currently known devices foresees decreasing the occlusion pressure in order to facilitate the blood supply of the BS through arterial blood, which our invention does by making use of a localized “MICRO-LEVITATION” which extends, during the operating cycle, over the entire body surface in contact with the device;

[0233] > none of the currently known devices considers that a BS originating from a “MINIMUM* occlusion pressure (which has an estimated and universally recognized valid value of 120 mmHg) in order to be treated it will have to receive an arterial flow with a pressure well above 120 mmHg, a value that almost no device reaches;

[0234] > the currently known devices perform their action on patients in a standard manner and any variability is empirically deduced thanks to the experience of the operators, our device provides “PRECISE INDICATIONS THAT MUST BE REFERRED TO THE PHYSICAL AND CLINICAL CONDITIONS OF EACH INDIVIDUAL PATIENT”: indications that allow you to cure the BS, prevent them and make recurrence impossible by respecting and evaluating the characteristic clinical conditions of the patient being treated.

[0235] Having examined and verified that the multiple treatment and prevention options for bedsores have nothing to do with our “finding”, we are certain of the uniqueness of our “finding* which will certainly provide modest help to further scientific study to eradicate bedsores.

[0236] ADVANTAGES OF THE DEVICE

[0237] The finding, as described above, certainly contributes to an improvement in the patient’s quality of life because by regressing necrosis and by regenerating tissues it eliminates the continuous (24 hours a day) pain that necrosis produces; furthermore, with is continuous massage, it improves blood circulation, bringing well-being to the patient’s entire body.

[0238] To more carefully evaluate the advantages offered by the device, the data that emerged from the CORTE National Congress (Italian Conference for the study and research on ulcers, sores, wounds and tissue repair, held in 2014 in Rome) are reported, which highlight what the appearance of a pressure ulcer entails: a) it increases the number of patients in hospital tenfold; b) it increases the risk of death fourfold; c) has a recurrence rate of no less than 70%; d) causes permanent disability in 30% of cases.

[0239] In light of these assessments, the advantages that can be obtained with the device can be listed as follows:

[0240] • reduction of nursing care;

[0241] • reduction of medicines;

[0242] • with the continuous use of the device, recurrence becomes impossible;

[0243] • improvement of quality of life with the elimination of pain;

[0244] • reduction of hospitalization.

[0245] Advantages, both in economic terms and quality of life, are not indifferent if we consider that the treatment of bedsores absorbs more than 4% of the expenses of the Italian National Health Service.

[0246] CONCLUSION

[0247] The device does not claim to solve the problem of bedsores, but it certainly helps to eradicate necrosis, avoiding recurrence and offering a clear improvement in the quality of life of those patients suffering from bedsores.

[0248] The methods described above are sufficient for the expert person to create the device, consequently, in a concrete application - for experts in the art - it will be immediately obvious that countless variations and modifications can be made to what has been described (for example relating to shape, dimensions, arrangements and parts with equivalent functionality) without departing from the scope of protection of the invention as appears from the claims which form an integral part of this description.

[0249] It is understood that, although the invention described here is fully capable of achieving the intended purposes and providing the advantages listed, the embodiments and features of the invention are purely illustrative.

[0250] Accordingly, we do not intend that the scope of our exclusive rights and privileges of the invention be limited to the details of the embodiments described.

[0251] We therefore intend that equivalents, adaptations and modifications of the invention, reasonably deducible from the description contained herein, are included in the scope of the invention as defined by the attached tables and claims.

Claims

AMENDED CLAIMS received by the International Bureau on 15 April 2025 (15.04.2025).1) Medical device [Fig. 1] suitable to treat bedsores, consisting of: a) an over-mattress [2 in Fig. 1] made up of (n) series of soft, flexible and small pipes, each series made by multiple pipes. Said pipes [Fig. 2] are connected to form a single, continuous and uninterrupted surface, arranged above and having the dimensions of an underlying mattress, b) an over-cushion made up of (n) series of soft, flexible and small pipes, each series made by multiple pipes, connected to form a single, continuous and uninterrupted surface, arranged above and having the dimensions of an underlying cushion; c) the serial quantity of pipes present in the over-cushion and in the over-mattress are identical; d) said pipes are arranged, both in the over-mattress and in the overcushion, in an alternating manner [pointed out as 31 / 32 / 33 in Fig. 2] that is, pipe no. 1 of the first series is located next to all the pipes no. 1 of the subsequent series up to pipe no. 1 of the nth series. In succession to pipe no. 1 of the umpteenth series there are pipe no. 2 of the first series flanked by all the pipes no. 2 of the other series, and so on until the last pipe of the last series; e) the pipes belonging to the same series aue connected to each other, whereby pipe no. 1 of the first series is connected to pipe no. 2 of the same first series but, between them there are all the pipes no. 1 belonging to all other series. Likewise, pipe no. 3 of the first series is connected to pipe no. 2 of the same first series but between them there are all the pipes no. 2 belonging to all other series. The arrangement of the subsequent pipes continues following the same pattern until covering the entire surface of the underlying mattress and the underlying cushion; f) the pipes referred to items a) and b) are:» all of the same diameter,• the pipes of the series that make up the over-mattress areconnected with the pipes of the corresponding series that make up the over-cushion,« inside said pipes a fluid, liquid or gaseous, flow through; g) two fireproof sheaths, washable and sterilizable at 90°C, which houses, the one, all the pipes referred in item a) and other houses all the pipes referred in item b); h) a manifold [3 in Fig. 1], placed under the cushion, whereby the manifold connects all the pipes series and distributes the filling fluid [pointed out as 31 / 32 / 33 in Fig. 2]; i) a device control unit which contains an air compressor (or a pump for liquid fluids), an electronic board to manage the operations, solenoid valves, pressure limiters and anything else needed for the correct management of the device. It may be located - depending on its size - on the bed footboard [pointed out as 4 in Fig. 1] or on the ground;1) the device control unit, referred to in item g), manage the operations so that, cyclically, at any time of the device operating, the filling fluid fills all the series at maximum pressure [pointed out as pipes (a) in Fig. 6] with the exception of only one series [pointed out as pipes (b) in Fig. 6] at zero pressure so that each series reaches, being pressured in circular mode, its maximum and minimum pressure during each of its cycle [Figs. 3, 4 and 5], “The cycle” it means that every pipes series starts its cycle at zero pressure and, after being pressurized - at pressure greater than zero - returns to zero pressure ending its “complete operating cycle”; and the device beingCHARACTERIZED BY THE FACT THAT• by having (n-1 ) pipes series simultaneously pressurized at pressure with- being “τ” [pointed out as (6) in Fig. 6] the pressure to be given tothe pressurized pipes [pointed out as (a) in Fig. 6], using formula (13);- being “ k ” a reduction coefficient [formula (11)];- being “ βR” = 70% β [formula (8)];- being "β ” the pressure acting on the occluded capillaries - according to Redfern S. [on Lancet magazine 1973] and depending on the bedsore location - assessed variable between“ 120 mmHg ≤ β ≤ 170 mmHg ” and with σP.... Kg cm-2- being “ σP” the uniformly distributed local pressure on that portion of the patient’s body area, where the bedsore is present, evaluating both the weight and the actual contact area with the mattress - in that same portion of the body - using formulas (5), (6) and “Rule of 9” [Wallace on Lancet magazine 1951] ;- being “p” the patient’s weight;- being “B.S.A.” the Body Surface Area [Dubois on Arch. Intern. Med. magazine 1916] pointed out as formula (5);* and a single series at zero-pressure pipesCA USE thanks to the double effect of- temporary and localized micro-le vitation: temporary because it is commensurate with the time[being the pressureapplication time during a single phase of the cycle (formula 16)] and localized because it acts on the capillaries which, cyclically, are found in the position pointed out as 8 in Fig. 6;- obstructing the normal blood flow in the capillaries pointed out as 7 in Fig. 6, due to pressure acting on them;A GREATER ARTERIAL BLOOD FLOW, resulting from the blood flow being prevented from passing through thecapillaries subjected to pressure \| / pointed out as 7 in Fig. 6, inside those capillaries that are located in correspondence with the zeropressure pipes series [pointed out as 8 in Fig. 6];2) device, as claimed in claim no. 1) and constituting the invention, beingCHARACTERIZED BY THE FACT THAT the pressure (highlighted in claim no. 1) multiplied by its application timei) being “ λ ” the pressurization time of one single series of pipes during a complete operating cycle [formula (4)] ii) being “ Tcycle” the time duration of a “complete operating cycle” whereby, said product ( \| / × λ ), must satisfy the following inequalities based on the patient’s B.S.A. value [formula (5)] and that is: a) for patients with B.S.A. greater than 1.50 m2it must be ( \| / × λ ) ≤ 1150 mmHg x 1 minute b) for patients with B.S.A. lower than or equal to 1.50 m2it must be ( \| / × λ ) ≤ 770 mmHg x 1 minute3) device, as claimed in claim no. 1) and in claim n° 2) and constituting the invention, beingCHARACTERIZED BY THE FACT THAT the value of the pressure (\| / R) that must act on the capillaries that flow inside the bedsore when it is in location pointed out as (8) [of Fig. 6] must satisfy the following inequality:- being- being k a reduction coefficient [formula (11)]4) device, as claimed in claim n° 1), in claim n° 2) and in claim n° 3) and constituting the invention, beingCHARACTERIZED BY THE FACT THAT the device pipes must have a diameter (Φ) between the following measurements20 millimeters ≤ Φ ≤ 40 millimeters5) device, as claimed in claim n° 1), in claim n° 2), in claim n° 3) and in claim n° 4) , and constituting the invention, being CHARACTERIZED BY THE FACT THAT it must be made up of a series (n) of pipes no less than “ 3 ”, that’s how it will have to be pipes series number ≥ 3 6) device, as claimed in claim no. 1), in claim no. 2), in claim no. 3), in claim no. 4) and in claim no. 5), and constituting the invention, beingCHARACTERIZED BY THE FACT THAT the conditions reported in claim no. 2), in claim no. 3), in claim no. 4) and in claim no. 5) must all be satisfied simultaneously.

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