WO2019223896A1 - Dispositif anti-escarres, lit anti-escarres, procédé de fabrication d'un matelas anti-escarres - Google Patents

Dispositif anti-escarres, lit anti-escarres, procédé de fabrication d'un matelas anti-escarres Download PDF

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Publication number
WO2019223896A1
WO2019223896A1 PCT/EP2019/000155 EP2019000155W WO2019223896A1 WO 2019223896 A1 WO2019223896 A1 WO 2019223896A1 EP 2019000155 W EP2019000155 W EP 2019000155W WO 2019223896 A1 WO2019223896 A1 WO 2019223896A1
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WIPO (PCT)
Prior art keywords
support
decubitus
mattress
previous
sensors
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PCT/EP2019/000155
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English (en)
Inventor
Valter COPETTI
Emiliano LEPORE
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Individual
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Individual
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61G—TRANSPORT, PERSONAL CONVEYANCES, OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS; OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES
    • A61G7/00—Beds specially adapted for nursing; Devices for lifting patients or disabled persons
    • A61G7/05—Parts, details or accessories of beds
    • A61G7/057—Arrangements for preventing bed-sores or for supporting patients with burns, e.g. mattresses specially adapted therefor
    • A61G7/05784—Arrangements for preventing bed-sores or for supporting patients with burns, e.g. mattresses specially adapted therefor with ventilating means, e.g. mattress or cushion with ventilating holes or ventilators

Definitions

  • Anti-decubitus device anti-decubitus bed
  • the present invention relates to an anti-decubitus device, to a bed comprising an antidecubitus device and to a method for manufacturing an anti-decubitus device.
  • anti-decubitus mattresses are known in the field of treatment of bedridden patients with reduced mobility or complete immobility, for example following injuries, surgery, serious diseases or pathologies. Because of the reduction of the blood circulation due to the prolonged mechanical compression of some zones of the patient’s body near the support surface on the bed, some problems of necrosis, lacerations and ulcers known as "bedsores" may arise.
  • the aim of the anti-decubitus mattress is to prevent or at least reduce the effect and the occurrence of bedsores or lesions in patients who are forced to lie in bed for long periods of time.
  • Some of the prior art solutions provide continuous or alternating low pressure pneumatic mattresses, which cause a movement of the patient on the bed by means of successive phases of inflation and deflation of different portions of the mattress.
  • the surface of the mattress is made up of air-filled hermetic cells that swell in an alternating way following the management by a computer system.
  • a movement of the surface of the mattress is induced in a cyclic way, independently of the presence of the user or of the position of the user on the mattress.
  • the reduction in the contact pressure is ensured for at least half of the duration of the operation cycle with an alternation of compression steps and decompression steps.
  • the cells are filled with air and enable the passive outlet of air by means of a turbine compressor.
  • the release of filtered air allows to counteract skin maceration since the air is conveyed onto the patient.
  • Beds are also known, which are provided with soft modules that exert a diversified pressure along the longitudinal development of the bed by means of liftable portions in correspondence of the chest zone and in correspondence of the leg zone.
  • Patent application US 2007/261548 describes a supporting element for preventing, reducing and treating decubitus ulcers and for the transfer of humidity or heat from the body of a user.
  • the supporting element comprises a multi-layer covering sheet that can be used to facilitate the removal of humidity, vapour and heat adjacent and proximal to the patient's superficial interface.
  • the support can include a system for facilitating an airflow to get through the surface.
  • the support can comprise a multi-layer structure for providing a reduced interface pressure between the patient and the covering sheet on which the patient is positioned.
  • the support comprises a first upper permeable layer, a third lower layer with an interposed second layer of spacing material can be made of an open-cell foam material.
  • Patent application US 4 472 847 describes a disposable or reusable "crawl resistant" flexible mattress formed of panels sealed together to define alternately inflatable passages between the panels for sequentially supporting structure for a long term bed patient to reduce decubitus ulcers and bed sores.
  • the mattress has vent holes in its top for ventilating the patient with inflation gas and a crawl resistant layer bonded to a bottom of the mattress to prevent the mattress from "crawling" relative to the bed and patient during use.
  • crawling is reduced by a separation between the inflation passages so individual sections of the mattress can more readily conform to a patient's body contour.
  • the crawl resistant layer is made of a non-woven fabric that is secured directly to a panel that has non-linear passages, such as zigzag or intersecting T-shapes.
  • non-linear passages such as zigzag or intersecting T-shapes.
  • the individual inflatable passages and the respective ridges they create can move independently of each other for more readily conforming to the contour of a patient's body. This separation between the inflatable passages can be made by a cut through the top and bottom panels at the time the top and bottom panels are heat sealed to each other.
  • Patent application EP 0 424 160 describes a seat and backrest construction in which the structure is provided with a hollow part in which temperature conditioned air is circulated.
  • the coil springs define the hollow part and a coating is fixed over the springs wherein the coating is made, from inside outwards, of a layer of metal mesh, of an elastomer sheet with openings for letting air through and of a layer of air-permeable fabric.
  • the elastomer sheet behaves as a viscous liquid when subjected to forces and impacts.
  • the prior art solutions are intended only for therapeutic purposes and not for prevention purposes, unlike the solution according to the present invention that is suitable both for therapeutic purposes and for preventing the occurrence of bedsores, thus being effective and providing valid assistance to the most varied types of patients who are subject to temporary or extended periods of total or partial immobilization.
  • the solutions resorting only to pneumatic mattresses are not able to ensure an effective detachment of the patient from the bed in the contact zones but are generally limited to creating pressure changes in some zones.
  • the resort to solutions that use only mattresses provided with selectively or consecutively inflatable zones may also involve the occurrence of further problems due to the movement of the surface supporting the patient or of the bed sheets with the consequent occurrence of friction between the bed sheets and the patient's body that, in their turn, can cause injuries or pain in the zones already affected by bedsores.
  • the prior art solutions can constitute an obstacle to the intervention in emergency conditions in case of problems related to a cardiopulmonary arrest because the presence of cells filled with air, as in the case of alternating pressure mattresses, constitutes an obstacle to cardiopulmonary resuscitation (CPR) procedures in emergency conditions and the removal of the anti-decubitus mattress is necessary before being able to intervene, with the consequence that precious time is wasted and there may arise further decompensation factors and handling problems by the - often reduced - hospital staff that must face cardiopulmonary arrest situations in obese patients, who are extremely difficult to be moved.
  • CPR cardiopulmonary resuscitation
  • Traditional mattresses optionally of the orthopaedic type, such as spring mattresses, water mattresses, air mattresses, foam mattresses, gel mattresses, are characterised by staticity with respect to the user's position and, as a consequence, due to the presence of a surface that remains static, that is to say, with no active movement, are not able to re-distribute the pressure applied.
  • the aim of the present invention is to provide an anti-decubitus device comprising an anti- decubitus mattress and a bed provided with said anti-decubitus device with improved efficiency that enable an effective action on the user's body also in the configurations in which one or more portions of the support plane of the mattress are partially lifted or bent with respect to a condition in which the support plane of the mattress is horizontal.
  • a further aim of the present invention is to provide an anti-decubitus device that allows preventing the occurrence of bedsores.
  • a further aim of the present invention is to provide a method for manufacturing an anti- decubitus mattress.
  • the solution according to the invention allows obtaining an on-site oxygenation and treatment of injuries of any nature, controlling and actively counteracting skin maceration.
  • the solution according to the invention also enables the control of the skin microclimate of the body in a support condition by enabling a natural perspiration of the skin, actively counteracting its maceration.
  • the solution according to the invention is cost-effective since it provides anti-decubitus mattresses of the disposable and single-patient type, very much to the advantage of hygiene in public hospital facilities.
  • Cost-effectiveness allows to facilitate its use for preventing pathologies related to bedridding or reduced mobility, with a more widespread distribution with respect to the prior art solutions that are expensive and/or little functional as well as unsuitable for a widespread distribution in hospitals and healthcare facilities.
  • Cost- effectiveness allows to further facilitate the use of the device according to the invention both in the hospital sector and at home.
  • the solution according to the invention acts in close contact with the patient's skin and, in the therapy of bedsores, stimulates vascularization, ensuring a better inflow of oxygen and nutrients in the affected zone, unlike the known solutions currently available on the market, which are not effective for this purpose. In this way, an activation of the wound is caused, which thus facilitates complete recovery from clinically and socially relevant pathologies.
  • the solution according to the invention allows to obtain an effective action of forced ventilation, evaporation, optimal skin perspiration that prevents possible humidity accumulation on the skin preventing its maceration; a tissue oxygenation that causes a better blood supply to the areas in contact and/or subject to potential bedsore problems.
  • the solution according to the invention allows bedridden patients to obtain improved hygiene conditions with reference to the prevention of phenomena of excessive localised humidity, while facilitating the patients' movements.
  • the solution according to the invention allows to prevent or at least reduce the occurrence of bedsores allowing to considerably limit the current cost of healthcare for dealing with the problem of bedsores that, for example, in Italy affects 2 million people.
  • the solution according to the invention enables the control and the adjustment of one or more parameters selected from humidity in the contact zones between the user and the device with a control action preventing humidity accumulation, pressure in the support zones of the user on the device with a control action to facilitate re-positioning or to limit the effects of a prolonged static support in the same position, body temperature of the user with a control action to facilitate a comfortable condition, level of oxygenation in the contact zones between the user and the device with a control action to counteract unfavourable conditions, presence of necrosis or lesions, movement of the user.
  • the device according to the invention advantageously allows to perform cardiopulmonary resuscitation (CPR) in emergency conditions because, unlike the prior art solutions, the device according to the invention is not provided with air-filled cells and does not need to deflate the cells or to move the patient onto another rigid surface, as for example in the case of alternating pressure mattresses.
  • the device according to the invention is a minimum thickness support that does not need to be removed to perform cardiopulmonary resuscitation manoeuvres in emergency because, as a matter of fact, the user is already on an essentially or sufficiently rigid surface that is a necessary requirement in order to be able to perform cardiopulmonary resuscitation. This allows the medical staff to be able to act promptly without further handling or movements of the user of the device in the case of occurrence of problems related to a cardiopulmonary arrest.
  • 3D material means a material or a fabric or a non-woven fabric having an internal alveolar structure in which basically most of the surface with which an external body can get in contact and/or most of its internal volume consists of spaces occupied by air, commonly known as void spaces.
  • Fig. 1 is a perspective view of the anti-decubitus device made in accordance with the present invention.
  • Fig. 2 is a perspective view of the anti-decubitus device of Fig. 1 in which some portions of the mattress of the anti-decubitus device have been sectioned and removed.
  • Fig. 3 is a side view of the detail indicated by“A” in Fig. 2.
  • Fig. 4 is a side view of the detail indicated by“B” in Fig. 2.
  • Fig. 5 is a schematic view of one of the components of the anti-decubitus device according to the invention showing some of the sensor devices applied.
  • Fig. 6 is a schematic view of one of the components of the anti-decubitus device according to the invention showing some of the sensor devices applied.
  • Fig. 7 is a schematic view of one of the components of the anti-decubitus device according to the invention showing some of the sensor devices applied.
  • Fig. 8 is a perspective view of the anti-decubitus bed provided with the anti-decubitus device made in accordance with the present invention.
  • Fig. 9 is a schematic sectional view of the anti-decubitus bed of Fig. 8.
  • Fig. 10, Fig. 11 , Fig. 12, Fig. 13, Fig. 14, Fig. 15, Fig. 16 are an operating sequence for manufacturing the mattress of the anti-decubitus device made in accordance with the present invention.
  • Fig. 17 is a perspective view of a different embodiment of one of the components of the anti- decubitus device according to the invention in which some portions of the device have been sectioned and removed.
  • Fig. 18 and Fig. 19 schematically show a possible embodiment of a display component of the anti-decubitus device made in accordance with the present invention.
  • Fig. 20 schematically shows a possible embodiment of an internal structure of a support of 3D material.
  • Fig. 21 schematically shows a possible embodiment of a system for removably applying acquisition sensors.
  • the present invention relates (Fig. 1 , Fig. 2) to an anti-decubitus device (1 ) comprising an anti-decubitus mattress (2), to a (Fig. 8, Fig. 9) bed (13) comprising the anti-decubitus device (1 ) and to a method (Fig. 10, Fig. 1 1 , Fig. 12, Fig. 13, Fig. 14, Fig. 15, Fig. 16) for manufacturing an anti-decubitus mattress.
  • a method Fig. 10, Fig. 1 1 , Fig. 12, Fig. 13, Fig. 14, Fig. 15, Fig. 16
  • the mattress (2) comprises (Fig. 10, Fig. 1 1 , Fig. 12, Fig. 13, Fig. 14, Fig. 15, Fig.
  • first support (44) which houses a system of tubular passages (9) each of which is provided with a series of outlet holes (10) for the outlet of (Fig. 9) a flow (14) of a gaseous fluid.
  • the system of tubular passages (9) enables an accurate and uniform distribution of the gaseous fluid below (Fig. 9) a user (54) of the anti-decubitus device (1 ), such as a bedridden patient or a patient on a wheelchair with reduced mobility or complete immobility, for example due to accidents, surgery, serious diseases or pathologies, old age.
  • the gaseous fluid can for example be selected from air taken by the environment, mixture of air and additional oxygen, mixtures of various gases, a pressurized gas extractable from wall outlets of a hospital structure.
  • the first support (44) is preferably made starting from a 3D material.
  • 3D material means a material or a fabric or a non-woven fabric having an internal alveolar structure (Fig. 20) in which basically most of the surface with which an external body can get in contact and/or most of its internal volume consists of spaces occupied by air, commonly known as void spaces.
  • the 3D material with the internal alveolar structure is characterised by an internal structure having variable rigidity that allows, by using very little material, to support even heavy weights. Thanks to the use of this material, the user is more in contact with the void spaces of the material rather than with the solid spaces of the same material, thus facilitating a reduction in the contact points between the user's skin and the first support (44). Therefore, the system of tubular passages (9) comprises at least one tubular passage (9), preferably a series of tubular passages (9).
  • tubular passage (9) can be made in the form of a coil in such a way that there is one single tubular passage.
  • the tubular passage (9) is inserted into the first support (44) in such a way that, from outside the first support (44), a respective first end is accessible, which is provided with an inlet (55) for feeding the flow (14) of gaseous fluid into the tubular passage (9).
  • the tubular passage is inserted into the first support (44) in such a way that, from outside the first support (44), a respective first end is accessible, which is provided with an inlet (55) for feeding the flow (14) of gaseous fluid into the tubular passage (9).
  • (9) is preferably provided (Fig. 4) with an ending portion (56) which seals a second terminal end of the tubular passage (9), the second terminal end being opposite with respect to the first end on which there is the inlet (55), the ending portion (56) sealing the second terminal end in such a way that the flow (14) of gaseous fluid introduced into the tubular passage (9) comes out only of the series of outlet holes (10) in order to generate the flow (14) of gaseous fluid directed towards the user (54) of the anti-decubitus device (1 ) who is lying or sitting on the anti-decubitus mattress (2).
  • the flow (14) of a gaseous fluid is introduced by means of a forced circulation system, enters the tubular passages (9) via the inlet (55), crosses the tubular passages (9), exits the holes
  • the forced circulation system comprises (Fig. 1 , Fig. 2, Fig. 8) a blower (6) fed by means of a feeder (7).
  • the blower (6) is configured to generate the flow (14) of gaseous fluid that is introduced into an outlet pipe (5) and that is distributed to the at least one tubular passage (9).
  • a flow distributor (4) which distributes the flow (14) of gaseous fluid from the outlet pipe (5) towards the series of tubular passages (9).
  • the flow distributor (4) can be provided with electro-valves or controllable shutting devices in such a way as to be able to adjust the flow (14) of gaseous fluid within each tubular passage (9) of the series of tubular passages (9) in an independent way, for example depending on control parameters managed by a processing unit (20) on the basis of signals coming from one or more sensors (16, 24, 28) of the anti-decubitus device (1 ).
  • a processing unit (20) on the basis of signals coming from one or more sensors (16, 24, 28) of the anti-decubitus device (1 ).
  • one can provide multiple blowers (6), each of which is pertinent to one or more tubular passages (9) arranged in different sections of the first support (44) of the mattress (2).
  • the blower (6) is preferably fed by means of silent or low-noise ventilation fans that force the passage of the flow (14) of gaseous fluid that is introduced into the outlet pipe (5) in such a way that the flow (14) of gaseous fluid, after having been distributed by the series of tubular passages (9), comes out of the series of outlet holes (10) exactly below the user (54) of the anti-decubitus device (1 ) who is lying or sitting on the anti-decubitus mattress (2), in particular, where the user (54) is in a support condition, a condition that for example can be detected on the basis of signals from one or more sensors (16, 24, 28) of the anti- decubitus device (1 ).
  • the reason for this technical choice of introducing forced air into the series of tubular passages (9) is due to the need for actively preventing the occurrence of possible skin maceration phenomena.
  • the first support (44) of the mattress (2) is obtained from a 3D material having a little compressible structure, thus advantageously obtaining a more effective contribution of gaseous fluid, such as air, oxygen or mixtures of various gases, also below the skin areas that are in a support condition and that thus exert a pressure on the underlying mattress, thus ensuring the best control of the skin microclimate of the body of the user (54) resting on the first support (44) of the mattress (2), enabling natural skin perspiration, actively counteracting the occurrence of any maceration phenomena or contributing to solving any maceration phenomena already present.
  • gaseous fluid such as air, oxygen or mixtures of various gases
  • the first support (44) included in the mattress (2) is a little compressible structure, it is ensured that the holes (10) made on the series of tubular passages (9) remain open, thus ensuring the continuity of the flow (14) of gaseous fluid in each support zone of the user (54) of the anti-decubitus device (1 ), independently of the applied pressure conditions due the weight of the user in specific support zones on the first support (44) of the mattress (2).
  • the anti-decubitus device (1 ) is a simple, practical, cost-effective device, preferably disposable and single-patient, which acts in close contact with the patient's skin and, in the therapy of bedsores, stimulates vascularization, ensuring a better inflow of oxygen and nutrients in the affected zone, unlike the prior art devices that are not equally effective also due to the squeezing of the relative first support causing an obstruction of the flow of gaseous fluid in the support zones of the user (54).
  • the anti- decubitus device (1 ) provides a flow (14) of gaseous fluid in each support zone of the user (54) with the consequence that it is possible to obtain a direct effect of treatment of the wound, thus facilitating the complete recovery from clinically and socially relevant pathologies. It is possible to prevent many decubitus lesions from getting worse; many others, instead, can be totally prevented. In fact, in case of still intact skin, the anti- decubitus device (1 ) performs a preventive action by considerably lowering the risk of occurrence of the lesion. It thus becomes ideal for anti-decubitus prophylaxis.
  • the anti-decubitus device (1 ) according to the invention can be used as a stand-alone system in a bed (13) or can be used superimposed to an additional traditional mattress in a bed (13) or can be used as a seating device for a wheelchair, for example for quadriplegic patients.
  • its preventive and therapeutic action is guaranteed in any case.
  • its application thanks to its cost-effectiveness, will be able to be extended both to a hospital and to a domestic sector.
  • the clinically and socially relevant pathologies for which the anti-decubitus device (1 ) according to the invention is intended are for example decubitus ulcers, diabetic ulcers, chronic ulcers of various nature (traumatic, vascular, neurologic, etc.), wounds of various nature (extended, transuding/exuding, chronic, sutured surgical, "road accident”, infected wounds, etc.), burns; highly invalidating pathologies that force to long-term bedridding or to the prolonged use of wheelchairs as, for example, fractures of the pelvis, fractures of both legs, fractures of one leg and one arm that do not allow to use Canadian crutches, polytrauma, head traumas with consequent coma or paralysis (paraplegia, hemiplegia, quadriplegia), vertebral traumas with injuries of the spinal marrow (paraplegia, quadriplegia), neurologic or muscle diseases that jeopardize to a various extent motility and also walking (multiple sclerosis, polyneuriti
  • the first support (44) made of a“3D” material with characteristics of low compressibility and having an internal structure with a high percentage of void spaces with respect to solid spaces one obtains inside the first support a large amount of air between the first support (44) and the user (54) of the anti-decubitus device (1 ) in every condition of pressure applied and, therefore, one ensures the presence of the flow (14) of gaseous fluid that from the holes (10) on the tubular passages (9) reaches the skin of the user (54). Thanks to the lift characteristics of the first support (44) made of“3D” material one also obtains an essentially uniform distribution of the contact pressure in the support zones, thus further facilitating an essentially uniform outlet of the flow (14) of gaseous fluid.
  • the series of tubular passages (9) is divided into at least two sections, of which a first section (1 1 ) is related to the back/pelvis/leg zone of the user (54) and a second section (12) is related to the calf/ankle zone of the user (54).
  • a third section related to the head/shoulder zone of the user (54).
  • the anti-decubitus device (1 ) can comprise an adjusting system for adjusting the intensity of the flow (14) of a gaseous fluid which is intended to adjust the intensity of the flow (14) of gaseous fluid of the first group of tubular passages (9) of the first section (1 1 ) in an independent way with respect to the intensity of the flow (14) of gaseous fluid of the second group of tubular passages (9) of the second section (12).
  • the blower (6) preferably comprises a system of fans, which consists of one or more fans.
  • the selected type is preferably a radial blower.
  • the blower (6) can be of the radial type with a flow rate adjusting signal.
  • the blower (6) can have a flow rate in a range between 0.20 m 3 /minute and 1.50 m 3 /minute, preferably in a range between 0.25 m 3 /minute and 1.00 nrvVminute, even more preferably in a range between 0.40 and 0.58 m 3 /minute, the provided values corresponding to environmental conditions at atmospheric pressure.
  • the incoming airflow is preferably axial, the outgoing airflow is preferably radial.
  • the weight of the rotor is preferably in a range from 0.01 kg to 1 kg, preferably in a range from 0.05 kg to 0.5 kg.
  • the blower (6) can have a size in a range between 1 mm and 200 mm, preferably a size with a width of less than 80 mm, a height of less than 75 mm, a depth of less than 60 mm.
  • the weight of the blower (6) is lower than 0.5 kg, even more preferably lower than 0.30 kg.
  • the maximum noise produced by the blower (6) in correspondence of the nominal operating point is preferably in a range between 1 dB and 60 dB, preferably between 3 dB and 50 dB.
  • the anti-decubitus device (1 ) further comprises an adjusting system for adjusting the temperature of the gaseous fluid of the flow (14) of gaseous fluid, ensuring the homeostasis of humidity and temperature.
  • the temperature of the gaseous fluid of the flow (14) of gaseous fluid can be adjusted by means of a conditioning unit of the gaseous fluid coming out of the blower (6).
  • the air conditioning unit can be a separate unit or a unit integrated in the blower (6).
  • the conditioning unit of the gaseous fluid can be a unit suitable both to cool and to heat the gaseous fluid coming out of the blower (6).
  • the heating can occur by means of heating resistors and the cooling can occur by means of Peltier cells or other equivalent systems.
  • the optimal temperature can be set for example on the basis of an ideal target temperature for the temperature of the user, which for example can be set on the basis of clinical requirements of the user as provided by the medical staff who can establish the use of particular temperatures of outlet of the flow (14) of gaseous fluid to obtain an external action of stabilization of the user also in case of patients subjected to intensive care procedures. Thanks to the presence of the adjusting system for adjusting the temperature, it is possible to advantageously compensate for changes in the user's temperature.
  • the blower (6) can incorporate an air heating system, optionally deactivable and provided with an anti-overheating system, which is controlled by the processing unit (20) according to signals coming from one or more sensors (16, 24, 28) of the anti-decubitus device (1 ).
  • the processing unit (20) although represented as a stand- alone, separate unit, will be preferably integrated in one of the components of the anti- decubitus device (1 ), for example in the body of blower (6) in order to reduce the number of components of the system.
  • the series of tubular passages (9) can comprise different numbers of tubular passages (9) arranged according to a longitudinal, transverse or longitudinal/transverse mixed configuration inside the first support (44).
  • the tubular passages (9) are arranged parallel to one another, transversely with respect to the first support (44) of the mattress (2), that is to say, in the width direction of the mattress (2).
  • the series of tubular passages (9) can comprise 12 tubular passages (9) but it is evident that the tubular passages (9) can also be provided in a number higher or lower than 12.
  • Each tubular passage (9) can have a size in section with a diameter in a range between 0.01 mm and 50 mm, preferably in a range between 0.1 mm and 20 mm. Each tubular passage (9) can have a length in a range between 1 cm and 500 cm, preferably in a range between 10 cm and 250 cm. Each tubular passage (9) can have a number of outlet holes (10) of the flow (14) of gaseous fluid in a range between 1 and 500, preferably between 2 and 100. Each hole (10) can have a size in section with a diameter in a range between 0.05 mm and 10 mm, preferably in a range between 0.1 mm and 8 mm.
  • Each tubular passage (9) is preferably provided (Fig. 3) with an inlet (55) connectable or connected to a feeding duct (3) of the flow (14) of gaseous fluid.
  • the duct (3) and the tubular passage (9) are one single body, but they can also be two distinct elements reciprocally fittable with each other.
  • Each tubular passage (9) is preferably provided (Fig. 4) with an ending portion (56) which is closed and blocks the flow (14) of gaseous fluid forcing it to come out only through the holes (10).
  • Each tubular passage (9) is inserted into an insertion seat (8) obtained within the thickness of the first support (44) of the mattress (2).
  • Each tubular passage (9) is connected to a flow distributor (4), which distributes the flow (14) of gaseous fluid from the outlet pipe (5) of the blower (6) towards the series of tubular passages (9).
  • the outlet pipe (5) can have a size in section with a diameter in a range between 0.01 mm and 50 mm, preferably in a range between 0.1 mm and 20 mm with a length in a range between 1 cm and 500 cm preferably in a range between 10 cm and 250 cm.
  • the tubular passages (9) are preferably flexible elements obtained by extrusion and can be made of silicone, PVC, PVC with no release of phthalates or other substances, PVC AM22M and PVC AM956.
  • the tubular passages (9) are preferably made of PVC, even more preferably of PVC suitable for medical applications that does not release phthalates.
  • An example of commercially available components suitable for use as a component for the tubular passages (9) is the product from ModenPlast under the trade name of RB5/M NDG that corresponds to tubular passages having a size with an internal diameter of 4.8 mm and an external diameter of 6.8 mm.
  • said component can be, for example, a component obtained by injection moulding made of silicone, PVC, PVC with no release of phthalates or other substances, PVC AM22M and PVC AM956.
  • the distributor (4) is preferably made of PVC, even more preferably of PVC suitable for medical applications that does not release phthalates.
  • An example of commercially available components suitable for use as a component for the distributor (4) is the product from TPV Compound under the trade name of PVC AM22W17 CRY that corresponds to a 12-way multi-connector.
  • said component for example can be a component obtained by injection moulding made of silicone, PVC, PVC with no release of phthalates or other substances, PVC AM22M and PVC AM956.
  • the pipe (5) is preferably made of PVC, even more preferably of PVC suitable for medical applications that does not release phthalates.
  • An example of commercially available components suitable for use as a component for the pipe (5) is the product from ModenPlast under the trade name of PVC RB4 that corresponds to a pipe having a size with an internal diameter of 20 mm and an external diameter of 24 mm.
  • said component for example can be a component obtained from a 3D material having an internal structure with a high percentage of free or void spaces with respect to solid spaces.
  • the 3D material can have the internal structure with a supporting alveolar net with a ratio between the volume occupied by free spaces with respect to the overall volume of the first support (44) in a range from 0.50 to 0.95, preferably from 0.70 to 0.90.
  • a material of the first support (44) having a ratio between the volume occupied by free spaces with respect to the overall volume of 0.85.
  • the first support (44) can have minimum thicknesses of 10 mm up to thickness values even of 100 mm.
  • the ratio between the internal volume consisting of the internal supporting alveolar structure and the internal volume consisting of free spaces is much lower than 1.
  • An example of a commercially available component suitable for use as a component for making the first support (44) is the product from Essedea GmbH & Co. KG under the trade name of 3DEA 303031 having the following technical specifications: material 100% polyester, thickness between 20 and 22 mm, weight in the order of 1.5 kg per each square metre of product, indentation hardness according to standard power at 40% in compliance with regulation DIN EN ISO 53579, Part 1 , indentation die with a diameter of 112.8 mm] 150 N +/- 10 N, air permeability [measured in accordance with regulation DIN EN ISO 9327] with side blow 2355 mm/s and without side blow 1032 mm/s, compression strain [measured in accordance with regulation DIN EN ISO 1856] after 10 minutes with a weight of 17 kg 0.15% / after 60 minutes with a weight of 17 kg 0.65% / after 24 hours with a weight of 17 kg 3.87% / after 10 minutes with a weight of 62 kg 1.33% / after 60 minutes with a weight of 62
  • An example of an alternative commercially available component suitable for use as a component for making the first support (44) is the product from Essedea GmbH & Co. KG under the trade name of 3DEA 303021 having the following technical specifications: material 100% polyester, thickness between 20 and 22 mm, weight in the order of 1.4-1.5 kg per each square metre of product, indentation hardness according to standard power at 40% in accordance with regulation DIN EN ISO 53579, Part 1 , indentation die with a diameter of 1 12.8 mm, 130 N +/- 10 N.
  • Examples of further alternative commercially available materials as components for making the first support (44) are the products from Essedea GmbH & Co. KG under the trade names of 3DEA 303025, 304025, 303073, 303023, 303072, 304045, 304072.
  • Examples of further alternative commercially available materials as components for making the first support (44) are the products from Muller Textil GmbH under the trade names of:
  • Examples of further alternative commercially available materials as components for making the first support (44) are the products from Tylex Letovice a.s. under the trade names of:
  • Examples of further alternative commercially available materials as components for making the first support (44) are the products from Pressless Gmbh under the trade names of:
  • Table 1 characteristics of alternative materials for the first support.
  • the material to be preferably used as a material for making the first support (44) is a material having one or more of the following characteristics:
  • a thickness between 18 and 60 mm such as a thickness selected from one of the following ranges: between 17 and 20 mm, between 20 and 22 mm, between 22 and 24 mm, between 24 and 27 mm, between 27 and 30 mm, between 30 and 33 mm, between 33 and 37 mm, between 37 and 41 mm, between 41 and 44 mm, between 44 and 47 mm, between 47 and 50 mm, between 50 and 55 mm, between 55 and 60 mm;
  • a weight per each square metre of product between 0.6 and 4.0 kg such as a weight per each square metre of product between 0.6 and 1.0 kg/m 2 or between 1.0 and 1.2 kg/m 2 or between 1.2 and 1.4 kg/m 2 or between 1.4 and 1.5 kg/m 2 or between 1.5 and 1.8 kg/m 2 or between 1.8 and 1.9 kg/m 2 or between 1.9 and 2.1 kg/m 2 or between 2.1 and 2.2 kg/m 2 or between 2.2 and 2.3 kg/m 2 or between 2.3 and 2.5 kg/m 2 or between 2.5 and 2.8 kg/m 2 or between 2.8 and 2.9 kg/m 2 or between 2.9 and 3.0 kg/m 2 or between 3.0 and 3.3 kg/m 2 or between 3.3 and 3.6 kg/m 2 or between 3.6 and 3.8 kg/m 2 or between 3.8 and 4.0 kg/m 2 ;
  • indentation die with a diameter of 1 12.8 mm between 80 N and 450 N, such as between 80 and 130 N, between 130 and 170 N, between 170 and 210 N, between 210 and 240 N, between 240 and 270 N, between 270 and 310 N, between 310 and 340 N, between 340 and 370 N, between 370 and 410 N, between 410 and 440 N;
  • the mattress (2) also comprises (Fig. 17), in addition to the previously described first support (44), a second support (33) superimposed to the first support (44).
  • the second support (44) in this case is an element that is interposed between the first support (44) and the user (54) of the anti-decubitus device (1 ).
  • the second support (44) is applied on the first support (44) in correspondence of the side of use of the mattress (2).
  • the second support can for example have the function of providing the user with greater comfort by creating greater thickness, that is to say, a cushioning function, yet without hindering or interfering too much with the flow of gaseous fluid towards the user.
  • the second support (33), too, is made of a “3D” material.
  • the thickness of the second support (33) is smaller with respect to the thickness of the first support (44) within which the tubular passages (9) are housed.
  • the second support (33) can have a thickness between 1/10 and 3/4 with respect to the thickness of the first support (44).
  • a first support (44) having a thickness between 10 and 60 mm one can use a second support (33) having a thickness between 1 and 45 mm.
  • the second support (33) has a thickness between 1 and 10 mm.
  • An example of a commercially available component suitable for use as a component for making the second support (33) is the product from Muller Textil GmbH under the trade name of T5683-0650-2450-0001 having the following technical specifications: material 100% polyester, thickness of 6.5 mm, weight in the order of 0.31 kg per each square metre of product, compression strength at 40% (DIN EN ISO 3386 / 1 +2) of 4 kPa.
  • the first support (44) and the second support (33) are reciprocally fixed to each other.
  • the fixing of the first support (44) and of the second support (33) occurs by means of gluing, preferably by means of gluing with a glue having characteristics of perimetric impermeabilization with respect to the passage of air in such a way that the flow (14) of gaseous fluid is forced to go through the second support (33) without side leaking.
  • a glue for medical applications like a glue based on cyclohexanone or the like.
  • the mattress (2) of the anti-decubitus device (1 ) can have a width in a range from 40 cm to 120 cm, preferably in a range from 60 cm to 80 cm.
  • the mattress (2) of the anti-decubitus device (1 ) can have a length in a range from 50 cm to 250 cm, preferably in a range from 90 cm to 220 cm.
  • the tubular passages (9) are inserted into the first support (44) within corresponding insertion seats (8) that ensure the correct housing of the tubular passages (9) in order to ensure that the user (54) does not feel the presence of the tubular passages (9) below their own body and, at the same time, the first support (44) provides a sufficient rigidity to compression to prevent the user's (54) weight from compressing the first support (44) to the extent of causing an obstruction of the tubular passages (9) or holes (10) preventing the correct and planned continuous outlet of the flow (14) of gaseous fluid. Therefore, the rigidity with respect to the compression of the first support (44) ensures the maintenance of a guaranteed minimum height not lower than the external diameter of the tubular passages (9). In this way the forced outlet of flow (14) of gaseous fluid below the user (54) is continuous and guaranteed over time, also in the contact zones with greater localised pressure.
  • the characteristics of the first support (44) ensure that, in the case in which the mattress (2) of the anti-decubitus device (1 ) is housed above other anti-decubitus equipment exerting a pneumatic, mechanical action of anti-decubitus movement, or an action of another type, the mattress (2) of the anti-decubitus device (1 ) is not an obstacle to this anti-decubitus movement action.
  • the mattress (2) of the anti-decubitus device (1 ) can be used in combination with additional anti-decubitus equipment exerting a pneumatic, mechanical action of anti-decubitus movement, or an action of another type, such as alternating air, air release, static anti-decubitus equipment and anti-decubitus equipment with a mechanical anti-decubitus mechanism.
  • additional anti-decubitus equipment that can be used is (Fig. 8, Fig. 9) an anti-decubitus bed (13) provided with a bed base (57) to be fixed to a bed (13) wherein the bed base (46) is provided with massaging means (53, 58, 17, 47, 48, 49, 50, 51 , 52).
  • the bed base (57) can be provided with massaging means (53, 58, 17, 47, 48, 49, 50, 51 , 52) comprising slats (58) arranged after one another and defining a support plane for the mattress (2) of the anti-decubitus device (1 ), each of the slats (58) being essentially arranged transversely with respect to a longitudinal direction (59) of the support plane.
  • the bed base (57) is divided into multiple contiguous areas (35, 36, 37, 38) arranged after one another along the longitudinal direction (59).
  • the areas (35, 36, 37, 38) are reciprocally hinged by means of respective hinging points (39, 40, 41 ) according to such a structure that at least some of the areas (35, 36, 37, 38) are movable and positionable according to at least two configurations of which a first configuration is a configuration in which the areas (35, 36, 37, 38) are reciprocally aligned and form the support plane and of which a second configuration is a configuration in which one or more of the areas (35, 36, 37, 38) are inclined with respect to the adjacent portion, the slats (58) being vertically movable by means of at least one rotary shaft (47, 48, 49, 50) provided with coupling means (53) for coupling with the slats (58).
  • the massaging means (53, 58, 17, 47, 48, 49, 50, 51 , 52) comprise a first drive (51 ) that sets in rotation a first articulated shaft (47, 48, 45) and a second drive (52) that sets in rotation a second articulated shaft (49, 50, 46).
  • the first articulated shaft (47, 48, 45) and the second articulated shaft (49, 50, 46) are mechanically disconnected and independent with respect to each other, the first articulated shaft (47, 48, 45) moving a first series of slats (58) that are arranged on a first group of said areas (35, 36) which is a distinct and independent group with respect to a second group of said portions (37, 38) comprising a second series of slats (58) moved by means of the second articulated shaft (49, 50, 46).
  • the areas (35, 36, 37, 38) are preferably four areas consisting of a first area (35), a second area (36), a third area (37), a fourth area (38).
  • the first area (35) is a fixed area with respect to which the second area (36) and the third area (37) are movable, the first area (35) constituting the coupling interface for fixing the bed base (57) to the bed (13).
  • the first area (35) is a fixed area meaning that it remains stationary during the movement of the other areas, said first area (35) being for example provided with fixing means for fixing the bed base (46) to a structure of the bed (13) so as to constitute one single integral assembly.
  • the first area (35) can be arranged in a longitudinal position corresponding to the support zone for the user's glutei.
  • the first area (35) comprises a respective first frame that acts as a fixing element for a series of slats (58).
  • the second area (36) can be the area that corresponds to the support zone for the user's back and head.
  • the second area (36) is movably fixed on a first side of the first area (35) by means of first hinging points (39) which enable a rotational movement of the second area (36) with respect to the first area (35), for example to allow the user to assume a position in which the glutei rest on the first area (35) arranged essentially horizontally while the back is kept inclined with respect to the horizontal position by means of the supporting action of the second area (36) when it assumes a position inclined by a certain angle with respect to the first area (35).
  • the second area (12) comprises a respective second frame that acts as a fixing element for a series of slats (58).
  • the third area (37) can be the area that corresponds to the support zone for the user's thighs.
  • the third area (37) is movably fixed to the first area (35) on a second side of the first area (35) that is opposite with respect to the first side of the first area on which the second area (36) is fixed.
  • the third area (37) is movably fixed to the first area (35) by means of second hinging points (40) which enable a rotational movement of the third area (37) with respect to the first area (35), for example to allow the user to assume a position in which the glutei rest on the first area (35) arranged essentially horizontally while the thighs are kept inclined with respect to the horizontal position by means of the supporting action of the third area (37) when it assumes a position inclined by a certain angle with respect to the first area (35).
  • the third area (37) comprises a respective third frame that acts as a fixing element for a series of slats (58).
  • the fourth area (38) can be the area that corresponds to the support zone for the user's legs and feet.
  • the fourth area (38) is movably fixed to the third area (37) on one side of the third area (37) that is opposite with respect to the side of the third area that is fixed to the first area (35).
  • the fourth area (38) is movably fixed to the third area (35) by means of third hinging points (41 ) which enable a rotational movement of the fourth area (38) with respect to the third area (37), for example to allow the user to assume a position in which the thighs rest on the third area (38) while the legs are kept inclined with respect to the thighs by means of the supporting action of the fourth area (38) when it assumes a position inclined by a certain angle with respect to the third area (37).
  • the fourth area (38) comprises a respective fourth frame that acts as a fixing element for a series of slats (58).
  • the bed base (57) and, thus, the bed (13) are provided with actuators that control the rotational movement of the areas (36, 37, 38) on the respective hinging points (39, 40, 41 ).
  • the first area (35) of the bed base (57), optionally in combination with the third area (37) can be an area corresponding to the first section (1 1 ) of the mattress (2) of the anti-decubitus device (1 ) that in its turn corresponds to the back/pelvis/leg zone of the user (54).
  • the second area (36) of the bed base (57) can be an area corresponding to the second section (12) of the anti-decubitus device (1 ) that in its turn corresponds to the calf/ankle zone of the user (54).
  • the fourth area (38) of the bed base (57) can be an area corresponding to the third section of the mattress (2) of the anti-decubitus device (1 ) that in its turn corresponds to the head/shoulder zone of the user (54).
  • the first articulated shaft (47, 48, 45) moves a first series of slats (58) that are arranged on a first group of areas (35, 36) that consists of the first area (35) and of the second area (36).
  • the second articulated shaft (49, 50, 46) moves a second series of slats (58) that are arranged on a second group of areas (37, 38) that consists of the third area (37) and of the fourth area (38), which is movable with respect to the third area (13) to which it is fixed by means of the respective third hinging point (41 ).
  • the first articulated shaft (47, 48, 45) consists (9) of a first shaft (47) and of a second shaft (48) that are connected to each other by means of a first joint (45) preferably in the form of a first universal joint.
  • the second articulated shaft (49, 50, 46) consists (Fig. 9) of a third shaft (49) and of a fourth shaft (50) that are connected to each other by means of a second joint (46) preferably in the form of a second universal joint.
  • the first shaft (47) is arranged below the first area (35)
  • the second shaft (48) is arranged below the second area (36)
  • the third shaft (49) is arranged below the third area (37)
  • the fourth shaft (50) is arranged below the fourth area (38).
  • the coupling means for coupling with the slats (58) are (Fig. 9) cams (53) provided with an eccentric zone and with an essentially non-eccentric zone with respect to a rotation fulcrum of the cam (53), the eccentric zone and the essentially non-eccentric zone being arranged on opposite sides with respect to the centre of the rotary shaft (47, 48, 49, 50).
  • the cams (53) are set in rotation by means of the rotary shaft (47, 48, 49, 50), each of the cams (53) being hooked to a corresponding slat (58) by means of a coupling interface, preferably in the form of a plate.
  • the coupling interface and the cam (53) are configured and structured in such a way as to:
  • the coupling interface and the cam (53) are reciprocally hooked to each other.
  • the cams (53) are cams having an eccentric profile and are arranged according to a configuration in which each cam (53) of the series of cams of each shaft (47, 48, 49, 50) is rotated with respect to the previous or following cam (53) by an angle of rotation between 50 and 70 degrees, preferably approximately of 60 degrees.
  • the coupling means or cams (53) are arranged along the first articulated shaft (47, 48, 45) and second articulated shaft (49, 50, 46) according to an arrangement such as to move vertically by deflection the slats (53) according to a sine wave shape.
  • a sine wave is created having an alternating decompression effect on all the surfaces of the body.
  • the induced sine wave can have a height between 2 and 5 cm, preferably of 3 cm, so as to cause detachment and to relieve the pressure on the user’s body parts.
  • the anti-decubitus movement of the bed base (57) is advantageously transmitted vertically without or only with partial attenuation to the user (54) who is on the mattress (2) of the anti- decubitus device (1 ) arranged on the bed base (57) of the bed (13).
  • the user (54) can enjoy both the benefits of the anti-decubitus equipment exerting a pneumatic, mechanical action of anti-decubitus movement, or an action of another type, and the benefits of the anti-decubitus device (1 ) generating the flow (14) of gaseous fluid below the user (54).
  • the movement of the slats has an effect on the mattress (2) of the anti-decubitus device (1 ), thus generating a slow variation of the support points of the user's body.
  • This movement has a double action since it decreases pressure on the zones at risk for the occurrence of bedsores and improves blood circulation, which is useful both for repair processes and for prevention, without causing a rise in the body temperature that would be harmful for any decubitus lesions present.
  • the first support (44) and the second support (33), if present, are preferably already made according to a size corresponding to the desired final size of the mattress or, as an alternative, can be obtained from a larger-sized sheet by means of a cutting phase, such as a laser cutting phase or a mechanical cutting phase, which is preferably followed by a hot air treatment on the perimeter of the first support (44) and of the second support (33), if present, that will prevent the structure of the 3D material from splitting apart.
  • a cutting phase such as a laser cutting phase or a mechanical cutting phase
  • the tubular passages (9) are inserted into the first support (44) by using internally hollow and essentially rigid pipes (34) having an internal diameter greater than the external diameter of the tubular passages (9). Therefore, the method for manufacturing the mattress (2) of the anti-decubitus device (1 ) provides the following steps:
  • the pipe (34) is provided with a first closed end (42) and with a second open end (43) that provides access to the hollow inside of the pipe * (34).
  • the first closed end (42) is shaped as a penetration tip, even more preferably shaped as a rounded penetration tip, facilitating the penetration of the pipe (34) into the first support (44);
  • first side and the second side are lateral sides of the support, that is to say, the long perimetric sides of the support, for the insertion of tubular passages (9) according to a transverse direction of insertion (66), but the same procedure can be applied by resorting to the short perimetric sides of the support for the insertion of tubular passages (9) according to a longitudinal direction of insertion (59).
  • each tubular element (9) will already be in the correct position, which will be kept automatically by the internal structure of the first support (44).
  • each tubular element (9) will be in the correct position, which will be kept automatically by the internal structure consisting of a thick network of filaments that make up the internal core of the“3D” material.
  • the steps for manufacturing the mattress (2) of the anti-decubitus device (1 ) and, preferably, each of its components occur in an ISO 8 class controlled environment. The assembly occurs by gluing with the solvent cyclohexanone in an ISO 7 class cleanroom and packaged in a sealed polyethylene bag.
  • the tubular passages are fixed in position, preferably by means of the solvent cyclohexanone, for example, in correspondence of the inlet zone of the tubular passage in the insertion seat, after having extracted the pipe in order not to get the pipe dirty with glue.
  • the mattress (2) of the anti-decubitus device (1 ) can be provided with one or more sensors (16, 24, 28) of one or more different types.
  • the signals of the sensors (16, 24, 28) are sent to at least one processing unit (20) that processes the received signals for the purpose of adjusting the flow (14) of gaseous fluid as to its intensity, its temperature, its specific parameters, such as humidity, any mixing percentages of different gases forming the gaseous fluid.
  • the signals of the sensors (16, 24, 28) can also be used by the processing unit (20) that, by processing the received signals, generates possible warning or alarm signals with respect to the conditions of the user (54) of the mattress (2) of the anti-decubitus device (1 ).
  • the one or more sensors (16, 24, 28) can be housed alone or in combination (Fig. 5, Fig. 6, Fig. 7) in correspondence of the upper part of the mattress (2) and/or inside the mattress and/or below the mattress (2) in such a way as to ensure the monitoring of control parameters of the processing unit (20) which will intervene with adjusting or signalling actions in order to diagnose in advance the occurrence of decubitus lesions through the monitoring of parameters such as the pressure in correspondence of the contact interface between the skin of the user (54) and the mattress (2) of the anti-decubitus device (1 ), the body temperature of the user (54), the skin humidity of the user (54), the tissue oxygenation of the skin of the user (54), the cellular necrosis of the skin of the user (54), local biochemical changes of the skin of the user (54), shear stress and movement of the user (54).
  • At least some of the one or more sensors (16, 24, 28) are applied on a fixing substrate that is provided with coupling devices (67) for the removable fixing to the first support (44), the first support (44) being provided with corresponding counter-coupling devices (68) for obtaining a coupling between the fixing substrate and the first support (44).
  • the coupling devices (67) and the counter-coupling devices (68) are reciprocal coupling devices of the magnetic type, although other solutions can also be provided, such as tear-off solutions.
  • the fixing substrate can also be made in the form of a protection cover of the sensors.
  • the one or more sensors (16, 24, 28) can comprise (Fig. 5) pressure sensors (16) which are intended to detect the pressure exerted by the body of the user (54) of the mattress (2) of the anti-decubitus device (1 ) in correspondence of the contact zones of the body of the user (54).
  • the pressure sensors (16) are preferably arranged on the whole surface of the mattress (2) of the anti-decubitus device (1 ) according to an arrangement such that the pressure sensors (16) are subdivided into multiple independent sectors (22) that are independently detectable and identifiable by the processing unit (20).
  • the signals from the pressure sensors (16) of each of the sectors (22) are preferably detected by means of electronic modules (17', 17", ..., 17 XIV ) which communicate by means of a connection (19) with a data concentrator (18) that in its turn sends the concentrated data of the pressure sensors (16) to the processing unit (20) by means of a communication channel (21 ) that, for example, can be a wireless communication channel such as a communication channel of the Bluetooth type or the like.
  • a communication channel (21 ) that, for example, can be a wireless communication channel such as a communication channel of the Bluetooth type or the like.
  • the pressure sensors (16) are preferably positioned (Fig. 5) on a second side (65) of the first support (44) that is opposite with respect to the first side (64).
  • the pressure sensors (16) are protected (Fig. 5) by a cover (63) that makes them easy to clean and sanify.
  • the pressure sensors are applied by means of their insertion into the cover (63).
  • the pressure sensors (16) can be directly applied to the first support (44) but in different embodiments the pressure sensors (16) can be applied on a fixing substrate that is then applied to the first support (44).
  • the fixing substrate can also be made in the form of a protection cover of the sensors, that is to say, the previously described cover (63) can act both as a cover and as a fixing substrate of the pressure sensors (16).
  • the fixing of the pressure sensors (16) to the fixing substrate can occur for example by means of a rolling phase or by means of magnetic strips or, more simply, by means of single magnets.
  • the fixing of the substrate to the first support (44) can occur by gluing or by means of the previously described embodiment in which the fixing substrate (Fig. 21 ) is provided with coupling devices (67) for the removable fixing to the first support (44), the first support (44) being provided with corresponding counter-coupling devices (68) for obtaining a coupling between the fixing substrate and the first support (44).
  • the set of pressure sensors (16) applied on the first support (44) is such as to essentially cover approximately the whole surface of the first support (44) in such a way that on the basis of the data collected by the pressure sensors (16) the device (1 ) is able to generate a map (61 ) representing the data collected by the, sensors in correspondence of the various acquisition points of the sensors essentially approximately on the whole surface of the mattress (2).
  • the sensitive area covered by the pressure sensors (16) can be of 90 cm x 180 cm with a number of detected pressure points in the order of 1000-2000 detection points.
  • the pressure sensors (16) can be positioned on the first support (44) according to a configuration in which the pressure sensors (16) are arranged on a matrix of acquisition points that essentially extends approximately on the whole surface of the mattress (2), wherein the matrix of acquisition points contains a number of acquisition points arranged according to a configuration of 48 acquisition points x 24 acquisition points.
  • the matrix of acquisition points contains a number of acquisition points arranged according to a configuration of 48 acquisition points x 24 acquisition points.
  • each sector (22) can have a size of about 45 cm x 60 cm.
  • each sector (22) can have a size of about 45 cm x 22.5 cm.
  • the pressure sensors (16) can be round-shaped sensors with a diameter in the order of 1-5 cm, such as of 2.26 cm, and having a detectable pressure range of 5-350 mmHg, and precision in the order of 3-15%, preferably precision in the order of 6-10%. Each sensor preferably has a horizontal and vertical detection resolution in the order of 2-6 cm, preferably of 3.75 cm.
  • the pressure sensors (16) are previously assembled on a mounting element, such as a flexible element of fabric or non-woven fabric, which is then applied on the mattress (2).
  • the one or more sensors (16, 24, 28) can comprise (Fig. 6) humidity sensors (24) which are intended to detect the humidity of the skin of the user (54) in correspondence of a contact zone with the skin of the user (54) of the mattress (2) of the anti-decubitus device (1 ).
  • the humidity sensors (24) are preferably arranged in correspondence of different portions (23) of the mattress (2) of the anti-decubitus device (1 ) according to an arrangement such that the humidity sensors (24) are subdivided into multiple independent portions (23) that are independently detectable and identifiable by the processing unit (20).
  • the signals from the humidity sensors (24) of each of the portions (23) can be collected by a communication unit (26) that sends the signals to the processing unit (20) by means of a communication connection (25) that, for example, can be a wireless communication connection such as a communication connection of the Bluetooth type or the like. It will be evident to those skilled in the art that multiple architectures of the system of humidity sensors (24), subdivision portions (23), communication unit (26) are possible and that the present invention is not to be considered as limited to the particular embodiment illustrated.
  • the humidity sensors (24) are made in form of humidity sensors of the impedance type, more particularly in the form of humidity sensors of the resistive type.
  • each humidity sensor (24) is provided with a first electrode and a second electrode, wherein each of the electrodes is shaped with transverse extension arms reciprocally spaced by a respective separation space, according to a configuration in which the transverse extension arms of the first electrode are transversely inserted into the separation space between transverse extension arms of the second electrode and vice versa in which the transverse extension arms of the second electrode are transversely inserted into the separation space between transverse extension arms of the first electrode (Fig. 6).
  • Films responsive to humidity are arranged between the arms of the electrodes in such a way as to be in contact with the electrodes themselves.
  • the films responsive to humidity can be electrolytic conducting polymers.
  • the humidity sensors (24) are arranged in correspondence of the first side (64) of the support (44) that is the side of the support (44) facing the user (54) of the anti-decubitus device (1 ).
  • the humidity sensors (24) can be previously assembled on a mounting element, such as a flexible element of fabric or non-woven fabric, which is then applied on the mattress (2).
  • the humidity sensors (24) are of the disposable type and are mounted on the mattress (2) in a condition of direct contact or very close to the skin of the user in order to detect the parameters thereof.
  • the one or more sensors (16, 24, 28) can comprise (Fig. 7) oxygenation sensors (28) which are intended to detect the oxygenation of the skin of the user (54) in correspondence of a contact zone with the skin of the user (54) of the mattress (2) of the anti-decubitus device (1 ).
  • the measurement of the oxygenation of the body tissues of the user is a very important parameter for the analysis of the state of health of the body tissues of the user. If the level of oxygenation of the body tissues is reduced, the body tissues can develop phenomena of ischemia, sores and other types of pathologies.
  • the oxygenation sensors (28) are preferably arranged in correspondence of different zones (27) of the mattress (2) of the anti-decubitus device (1 ) according to an arrangement such that the oxygenation sensors (28) are subdivided into multiple independent zones (27) that are independently detectable and identifiable by the processing unit (20).
  • the signals from the oxygenation sensors (28) of each of the zones (27) can be collected by a linking unit (30) that sends the signals to the processing unit (20) by means of a communication link (29) that, for example, can be a wireless communication link, such as a communication link of the Bluetooth type or the like.
  • the oxygenation sensors (28) are of the non-invasive type, such as oxygenation sensors (28) based on impedance spectroscopy.
  • the latter is a condition of reduced oxygenation and reduced inflow of nutrients of the body tissues of the user due to constrictions or obstructions of the blood vessels.
  • Ischemia obliges the body tissues to work in anaerobic conditions.
  • the most known forms of ischemia are brain ischemia and heart ischemia but also the body tissues can be subject to ischemia. Different types of body tissues react in a different way to ischemia.
  • the impedance of a biologic body tissue it is the result of the interaction of an electric current with the tissue on a cellular and molecular level.
  • the impedance spectroscopy is a measure of the complex impedance in a given range of frequencies. Impedance is established by injecting a sub-threshold current, typically lower than 1 mA/cm 2 into the tissue measuring the resulting voltage.
  • a sub-threshold current typically lower than 1 mA/cm 2
  • oxygenation sensors (28) based on impedance detection technology, they can have a size in the order of 1x1 cm, 2x2 cm, 3x3 cm, 4x4 cm, 5x5 cm or larger. Each sensor preferably has a horizontal and vertical detection resolution in the order of 2-8 cm, preferably of 4.5 cm.
  • the oxygenation sensors (28) are of the disposable type and are mounted on the mattress (2) in a condition of direct contact or very close to the skin of the user in order to detect the parameters thereof.
  • oxygenation sensors (28) For each of the different zones (27) of the mattress (2) of the anti-decubitus device (1 ) that are provided with oxygenation sensors (28) there at least three oxygenation sensors (28), but one can provide solutions with a greater number of sensors, such as a number of sensors of 4, 5, or more oxygenation sensors (28) for each of the zones (27) of the mattress (2) of the anti-decubitus device (1 ) that are provided with oxygenation sensors (28).
  • the oxygenation sensors (28) form (Fig. 7) a detection surface consisting of different zones.
  • the oxygenation sensors (28) are previously assembled on a mounting element, such as a flexible element of fabric or non-woven fabric, which is then applied on the mattress (2).
  • the processing unit (20) is a separate unit with respect to the blower (6) one can provide (Fig. 2) a control channel (31 ) by means of which the processing unit (20) communicates adjustment data of the blower (6) to adjust the flow (14) of gaseous fluid as to its intensity, its temperature, its specific parameters such as humidity, any mixing percentages of different gases forming the gaseous fluid.
  • the anti-decubitus device (1 ) can be associated with a cushion (32) provided with a sensor or sensors of the cushion (62), which can be selected from the previously mentioned sensors. That is to say, the sensor or sensors of the cushion (62) can be one or a combination of sensors selected from pressure sensors (16), humidity sensors (24), oxygenation sensors (28). Preferably the sensors of the cushion (62) comprise at least one series of pressure sensors (16).
  • the anti-decubitus device (1 ) can be associated with a monitor (60) for displaying the data collected by the sensors (16, 24, 28), which can be displayed, for example, in the form of at least one map (61 ) representing the data collected by the sensors in correspondence of the various acquisition points of the sensors on the surface of the mattress (2).
  • the map (61 ) can represent the data correspondingly with an acquisition position on the surface of the mattress (2).
  • the map (61 ) can be a colour map in which each colour corresponds to a given range of detected value.
  • average values can be displayed on the monitor.
  • alarm signals can be displayed on the monitor in case of detection of values of the data acquired by the sensors (16, 24, 28) out of thresholds corresponding to essentially normal conditions of the data acquired by the sensors with respect to those expected for the user (54) of the anti-decubitus device (1 ).
  • the anti-decubitus device (1 ) can be associated with a control unit (15) by which the user (54) can transmit adjusting controls to the processing unit, for example to adjust the value of the flow (14) of gaseous fluid as to its intensity, its temperature, etc.
  • the control unit (15) can integrate, in addition to the adjusting functions of the anti-decubitus device (1 ), the adjusting functions of the anti-decubitus bed (13) as well.
  • the anti-decubitus device (1 ), the bed base (57) in combination with the anti- decubitus device (1 ) or the bed (13) in combination with the bed base (57) and with the anti- decubitus device (1 ) can be configured both for use in hospitals and for domestic or private use.
  • an anti-decubitus device (1 ) comprising a mattress (2) provided with one or more tubular passages (9) and a blower (6) which is intended to generate a flow (14) of a gaseous fluid, the blower (6) being connected to a conveying system of the flow (14) of gaseous fluid from the blower (6) towards the one or more tubular passages (9) of the mattress (2), wherein the mattress (2) comprises at least one first support (44), wherein the first support (44) is made in the form of a body having an internal structure with a supporting alveolar net provided with free spaces.
  • the one or more tubular passages (9) are positioned inside the internal supporting alveolar structure and the one or more tubular passages (9) are provided with a series of outlet holes (10) for the flow
  • the holes (10) are arranged on the one or more tubular passages (9) according to a heading direction of the flow (14) of gaseous fluid that is directed towards a first side (64) of the first support (44) of the mattress (2) constituting a support surface for a user (54) of the anti-decubitus device (1 ).
  • the internal structure with a supporting alveolar net is intended to support the weight of the user (54) of the anti-decubitus device (1 ) in conditions of absence of squeezing of the one or more tubular passages (9).

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  • Health & Medical Sciences (AREA)
  • Nursing (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Invalid Beds And Related Equipment (AREA)
  • Mattresses And Other Support Structures For Chairs And Beds (AREA)

Abstract

Un dispositif anti-escarres (1) comprend un matelas (2) pourvu de passages tubulaires (9) et d'une soufflante (6) pour générer un écoulement de fluide (14) dans les passages (9), le matelas (2) comprenant au moins un premier support (44) ayant une structure interne avec un filet alvéolaire de support, les passages tubulaires (9) étant positionnés à l'intérieur de la structure interne, les passages tubulaires (9) comprenant une série de trous de sortie (10), dirigés vers un premier côté (64) du premier support (44) du matelas (2), ledit premier côté constituant une surface de support pour un utilisateur (54), la structure interne étant destinée à supporter le poids de l'utilisateur (54) dans une condition d'absence de compression des passages tubulaires (9), le dispositif (1) comprenant au moins une unité de traitement (20), le matelas (2) du dispositif (1) étant pourvu d'un ou de plusieurs capteurs (16, 24, 28), destinés à envoyer des données de mesure à l'unité de traitement (20), caractérisé en ce que l'unité de traitement (20) est pourvue d'un dispositif de réglage pour régler l'écoulement (14) du fluide gazeux en fonction des données de mesure du ou des capteurs (16, 24, 28). Procédé de fabrication d'un matelas anti-escarres (2) caractérisé en ce qu'il comprend les étapes suivantes consistant à : (a) pré-agencer un premier support (44) du matelas (2) ayant une structure interne avec un filet alvéolaire de support pourvu d'espaces libres; (b) préparer au moins un élément tubulaire (9) ayant une série de trous de sortie (10) pour un écoulement (14) de fluide gazeux; (c) obtenir un siège d'insertion (8) en insérant un tuyau (34) intérieurement creux et essentiellement rigide de telle sorte qu'une première extrémité (42) du tuyau (34) pénètre dans le premier support (44) jusqu'à la première extrémité (42) du tuyau (34) sort du premier support (44); (d) insérer l'élément tubulaire (9) dans le tuyau (34) au niveau d'une seconde extrémité ouverte (43) du tuyau (34) jusqu'à une insertion complète correspondant à la longueur du siège d'insertion (8); (e) verrouiller l'élément tubulaire (9) par rapport au premier support (44); (f) extraire le tuyau (34) du premier support (44) dans le sens d'insertion de telle sorte que l'élément tubulaire (9) est extrait du tuyau (34), laissant ainsi l'élément tubulaire (9) libre à l'intérieur du siège d'insertion (8) creusé par le tuyau (34).
PCT/EP2019/000155 2018-05-21 2019-05-17 Dispositif anti-escarres, lit anti-escarres, procédé de fabrication d'un matelas anti-escarres Ceased WO2019223896A1 (fr)

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IT102018000005532A IT201800005532A1 (it) 2018-05-21 2018-05-21 Dispositivo antidecubito, letto antidecubito, metodo di realizzazione di materasso antidecubito
IT102018000005532 2018-05-21

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CN113491408A (zh) * 2020-04-07 2021-10-12 Lg电子株式会社 床的控制方法
EP3892159A1 (fr) * 2020-04-07 2021-10-13 LG Electronics Inc. Lit
US11779126B2 (en) 2020-04-07 2023-10-10 Lg Electronics Inc. Bed
DE102022120259A1 (de) * 2022-08-11 2024-02-22 BH Holding GmbH Vorrichtung zur Messung von Druck, Feuchtigkeit und/oder Temperatur
WO2024164029A3 (fr) * 2023-02-02 2024-10-24 Universal Tech Corporation Dispositif de prévention de décubitus
IT202300017814A1 (it) * 2023-08-30 2025-03-02 Starnem Srl Sistema di ausilio per la movimentazione di pazienti.
CN119857031A (zh) * 2024-11-19 2025-04-22 中科泛米(安徽)科技有限公司 一种ai智能防褥疮监护仪
CN120227241A (zh) * 2025-05-30 2025-07-01 厦门大学附属第一医院(厦门市第一医院、厦门市红十字会医院、厦门市糖尿病研究所) 一种医疗监护护理监测报警装置

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CN113491408A (zh) * 2020-04-07 2021-10-12 Lg电子株式会社 床的控制方法
EP3892159A1 (fr) * 2020-04-07 2021-10-13 LG Electronics Inc. Lit
US11779126B2 (en) 2020-04-07 2023-10-10 Lg Electronics Inc. Bed
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