Device for supporting the head of a human body

Abstract

The invention relates to a device for supporting the head of a human body in the supine position in a horizontal plane. According to the invention, the device consists of at least two pneumatic chambers superimposed in the vertical direction, at least two pneumatic chambers being non-removably connected, the at least two chambers consisting of at least two thermoplastic polymer sheets, one of the at least two thermoplastic polymer sheets being shared by the at least two pneumatic chambers, at least one of the at least two pneumatic chambers consisting of at least two thermoplastic polymer sheets connected at their periphery and at least one substantially vertical wall consisting of a thermoplastic polymer sheet welded along its length to each of the inner surfaces of two of the at least two thermoplastic polymer sheets, and at least the pneumatic chamber lying in the horizontal plane being kept under pressure.

Description

HUMAN HEAD SUPPORT DEVICE

[0001] The present invention relates to a device for supporting the head of a human body in a fixed position. Although not limited to this type of application, the invention will be described more particularly with reference to the case of patients in a hospital setting when they are to undergo surgery, whose head must be stable and in a specific position.

[0002] Other types of applications include pillows or headrests for hospital or home use to provide support and comfort in a specific position.

[0003] In many situations, hospitalized patients, whether in a room or in the operating room, must remain lying still on their backs or in a supine position. Regardless of the mattress quality, it is necessary to keep the head elevated to avoid disturbing the cervical vertebrae and to maintain spinal alignment. During surgery, it may also be necessary to reposition the head during the procedure to access specific areas.

[0004] One technique currently used in hospitals involves the use of foam or gel wedges. These types of wedges do not allow for adjusting the head support height and therefore cannot be adapted to different patient body shapes or specific surgical situations.

[0005] Document EP0736278A1 describes an inflatable cushion designed to improve the comfort of a patient who must remain seated. This cushion consists of multiple fluid-filled cells that control the flow of fluid from one cell to another. Such a device offers no guarantee of stability and does not allow for adjustment of head position.

[0006] US patent 20170065473A1 describes an inflatable device for supporting an individual, allowing for simplified application. When used for head support, this type of device does not provide the desired stability.

[0007] Document WO98 / 55013 describes a device for supporting a body during radiographs, comprising inflatable parts to allow positioning of the body.

[0008] The inventors have thus set themselves the task of proposing a support device for the head of a human body, allowing the user to choose a support height and ensuring improved stability compared to known devices.

[0009] This goal has been achieved according to the invention by a device for supporting the head of a human body in a supine position on a horizontal plane, said device being made up of at least two pneumatic chambers superimposed in the vertical direction, at least two pneumatic chambers being linked in a non-removable manner, said at least two chambers being made up of at least two sheets of thermoplastic polymer, one of said at least two sheets of thermoplastic polymer being common to said at least two pneumatic chambers,at least one of said at least two pneumatic chambers being made up of at least two sheets of thermoplastic polymer joined at their periphery and at least one substantially vertical wall made up of a sheet of thermoplastic polymer welded along its length to each of the internal surfaces of two of said at least two sheets of thermoplastic polymer and at least the pneumatic chamber resting on the horizontal plane being kept under pressure.

[0010] The head support device for a human body thus described according to the invention makes it possible to support the head of the human body in a desired position while reducing the risk of unwanted displacement.

[0011] The inventors were first able to demonstrate that the superposition of inflatable chambers makes it possible to adjust the height of head support.

[0012] The inventors also demonstrated that pressurizing at least one pneumatic chamber resting on the horizontal plane and ensuring the fixed connection between two chambers provides entirely satisfactory stability to the device. In particular, the inventors believe that, for a given height, the vertical superposition of at least two chambers provides greater stability than a device consisting of a single pneumatic chamber. Furthermore, they believe that reducing the height of the support device requires the presence of at least two vertically superimposed pneumatic chambers, which allows for... Inflating only one air chamber allows for greater stability compared to a device consisting of a single air chamber, for which it would be necessary to reduce the inflation pressure of the single air chamber.

[0013] Furthermore, the common part of two pneumatic chambers, which constitutes the common thermoplastic polymer sheet, which notably gives the immovable character of the connection between said two pneumatic chambers, contributes to the stability of the support device for the head of a human body according to the invention.

[0014] Advantageously according to the invention, said at least one substantially vertical wall is advantageously dimensioned to create two volumes which communicate with each other to allow the inflation of the pneumatic chambers from a single orifice.

[0015] Said at least one substantially vertical wall, according to its dimensions, defines the distance between said two sheets of thermoplastic polymer and defines the external shape of the pneumatic chamber. It thus further contributes to the good stability of the head support device for a human body according to the invention.

[0016] The pneumatic chamber advantageously comprises several substantially vertical walls, each consisting of a thermoplastic polymer sheet welded along its length to each of the internal surfaces of said two thermoplastic polymer sheets. Their distribution within the pneumatic chamber allows for optimal definition of the chamber's external shape, thereby contributing to the stability of the head support device for a human body according to the invention.

[0017] According to an advantageous embodiment of the invention, the pneumatic chamber on which the head rests directly is maintained at a pressure under load of less than 20 millimeters of mercury (mmHg).

[0018] For the purposes of the invention, a pressure under load corresponds to the pressure measured when the head of the human body is resting on the support device.

[0019] The inventors have further highlighted that the pneumatic chamber which directly supports the head, at such pressure, provides comfort and in the case of prolonged pressure can help to avoid or at least limit the appearance of bedsores.

[0020] Pressure sores or necrosis can occur when pressure is exerted by the patient's weight between bony prominences and pressure points on the skin and These skin lesions result from prolonged pressure on certain parts of the body, leading to tissue ischemia and significant skin damage.

[0021] The inventors have indeed shown that the superimposed pneumatic chambers which are thus inflated according to the invention make it possible to maintain the head in the chosen position in a stable manner, providing comfort to the individual and limiting the risk of pressure sores.

[0022] According to one embodiment of the invention, a pneumatic chamber of the head support device for a human body is made of at least two sheets of thermoplastic polymer preferably having a tensile modulus at 10% elongation of less than 20 MPa, said at least two sheets of thermoplastic polymer being heat-welded edge to edge at their periphery. The pneumatic chamber of the device then has the shape of a cushion.

[0023] In another embodiment, a pneumatic chamber for the human head support device consists of at least three thermoplastic polymer sheets. Two of these sheets are connected at their periphery by a third thermoplastic polymer sheet forming a vertical wall. This third thermoplastic polymer sheet is heat-sealed to the periphery of the first two thermoplastic polymer sheets. The three thermoplastic polymer sheets thus form a mattress-shaped pneumatic chamber. Preferably, the three thermoplastic polymer sheets have a tensile modulus at 10% elongation of less than 20 MPa.

[0024] The measurements of the modulus of elasticity under tension at 10% elongation are carried out according to the DIN 53504 standard.

[0025] The heat sealing of thermoplastic polymer sheets can be carried out in particular by ultrasound, conduction or high frequency.

[0026] Preferably, the thermoplastic polymer sheet(s) have a tensile modulus at 10% elongation of less than 10 MPa.

[0027] Preferably, the thermoplastic polymer sheet(s) should have a thickness of less than 1 mm and preferably even less than 0.5 mm.

[0028] Such a material allows, in a known manner, the simple fabrication of a component with a sealed pneumatic chamber that can be pressurized. A particularly suitable material is thermoplastic polyurethane. Heat sealing can be achieved by locally heating the sheet to its melting temperature. The sheet's rigidity helps reduce the risk of pressure sores when it is in contact with the skin. Heat sealing can be performed using ultrasound, conduction, or high frequency.

[0029] The choice of this thin and deformable material allows it to conform to the head of the supported human body and thus optimize the contact surface between the support device and the head of the human body.

[0030] Furthermore, manufacturing the head support device for a human body from a heat-weldable material allows for relatively precise shaping. The shape of the support device can be defined using heat welding.

[0031] When the at least two pneumatic chambers of the support device are made of at least two sheets of thermoplastic polymer, the thermoplastic polymer sheet(s) not in contact with the skin are advantageously reinforced. This reinforcement may be fiber-based or fabric-based and results in a thermoplastic polymer sheet that is stiffer than one having a tensile modulus of elasticity at 10% elongation of less than 20 MPa.

[0032] According to one embodiment of the invention, the head support device of a human body consists of at least three pneumatic chambers.

[0033] According to this embodiment of the invention, in the case of three pneumatic chambers, according to a first embodiment, the third pneumatic chamber is advantageously permanently linked to one of the other two pneumatic chambers. When said third pneumatic chamber is made of at least two sheets of thermoplastic polymer, it advantageously shares one of these sheets with another pneumatic chamber.

[0034] According to this same variant of the invention, according to a second embodiment, the third pneumatic chamber can also be linked to another pneumatic chamber in a detachable manner by any separable linking means known to a person skilled in the art.

[0035] Separable fastening means include, for example, Velcro® type devices, each part of which is fixed to the surface of a pneumatic chamber by welding, sewing or any other suitable means.

[0036] Separable fastening means can also be any other type of fastening system that is advantageously simple to use, such as, for example, detachable zipper fasteners or any type of quick-release buckle system.

[0037] According to a preferred embodiment of the invention, each of the pneumatic chambers includes an inflation orifice.

[0038] Such inflation ports are, for example, connected to a tube and possibly a valve. These inflation ports, present on each of the pneumatic chambers, ensure that the required pressure is maintained for each chamber under the weight of the human head pressing against it, and allow for the possible control of the different pressures during the use of the device.

[0039] The inflation ports are advantageously positioned for easy access during use and to prevent contact with the human body. They are advantageously connected to tubes that allow for remote connection to the inflation device and may be joined together to facilitate pressurizing the air chambers.

[0040] The inflation ports are advantageously further associated with flap valves or tubes associated with "clamp" type clamps to ensure the best possible seal.

[0041] An advantageous embodiment of the invention provides that at least a portion of the surface of said device coming into contact with the head of a human body is covered with a 3D spacer fabric known as "3D spacer".

[0042] For the purposes of this invention, "3D spacer fabrics" are fabrics made in three dimensions, such as the "XD Spacer Fabrics" marketed by Baltex or the "3D MESH SPACER FABRIC" marketed by Muller, which are already used in medical applications. These three-dimensional fabrics have the advantage of providing ventilation to the surface of the human skin in contact with the support module. Such fabrics are described for example in documents US 2018187348, EP 1347087, EP 2408957, WO 2012098130.

[0043] Such "3D spacer" fabrics can be woven or knitted, consisting of two layers connected by one or more filaments. These filaments can be made of various materials: polyester, polyamide, polypropylene, or cotton. They can be used in their raw form, or coated or coated to modify the texture or limit the growth of viruses or bacteria. These filaments possess a certain resilience conferred by their diameter, which is greater than 30 microns, preferably greater than 100 microns, and with a density and pattern adapted to withstand compressive forces. This gives the "3D spacer" fabric buckling strength, that is, resistance to compression or buckling of these filaments.

[0044] Advantageously, the "3D spacer" fabric exhibits a buckling stress greater than the inflation pressure of the pneumatic chamber.

[0045] In the context of this invention, the buckling stress of the fabric is the stress perpendicular to the median plane of the fabric that causes the filaments connecting the two surfaces to buckle. Beyond this stress, the two fabric surfaces come very close together and can no longer perform their ventilation function.

[0046] The average plane of the fabric corresponds to the surface of the fabric when it is laid flat.

[0047] The buckling stress is measured according to ISO 3386-1.

[0048] Even more advantageously, the buckling stress of the "spacer 3D" fabric is less than 0.2 bar.

[0049] Such buckling constraints make it possible to combine ventilation of the human body's skin and supportive comfort.

[0050] According to a preferred embodiment of the invention, the thickness of the "3D spacer" fabric is less than 10 mm.

[0051] Preferably according to the invention, the air permeability of the "3D spacer" fabric is greater than 1000 l / dm² 2 xmin under a pressure of 1 mbar.

[0052] The permeability of the tissue is measured according to the ISO 9237 standard.

[0053] The presence of a "3D spacer" fabric, advantageously presenting characteristics such as those described above, in contact with the skin of the supported body allows for the evacuation of moisture and heat and thus helps to preserve the skin which comes into contact with the support device.

[0054] According to one embodiment of the invention, the "3D spacer" fabric is provided to be removable and separable from the first element so that it can be properly cleaned and / or changed regularly.

[0055] It is still possible to provide a cover made with the "3D spacer" fabric enveloping the entire head support device of the human body, these covers being designed to be removable so that they can be properly cleaned and / or changed regularly.

[0056] Advantageously according to the invention, the inflation of the pneumatic chambers of the head support device of a human body is carried out with an inert and / or purified gas to avoid any additional risk of infection in the event of an accident on one of the pneumatic chambers leading to a leak, particularly when used in a hospital setting.

[0057] The invention as described above offers several other advantages, particularly those related to the inflatable nature of the components of the head support device for a human body. Indeed, the use of inflatable components allows their volume to be reduced when not in use or before use, thus facilitating storage.

[0058] Another advantage of the human head support device as presented relates to manufacturing costs, particularly due to the materials chosen. Indeed, the low cost of producing the support device according to the invention also allows for the availability of devices in different sizes or shapes for better adaptation to the size or build of the human body.

[0059] Combined with the gain in volume and the low cost of the support system, it becomes possible to store a large number and variety of these elements and thus have at any time the model best suited to the situation, particularly in terms of variety of shapes.

[0060] Other advantageous details and features of the invention will become apparent from the description of the examples of embodiments of the invention with reference to figures 1 to 4 which represent: figure 1, a schematic representation of a first embodiment of a support device according to the invention, figure 2, a schematic representation, top view, of the first embodiment of a support device according to the invention, figure 3, a schematic representation of a second embodiment of a support device according to the invention, figure 4, a schematic representation, top view, of the second embodiment of a support device according to the invention.

[0061] The figures are not shown to scale to simplify understanding.

[0062] In Figure 1, the head support device of a human body 1 comprises two superimposed pneumatic chambers 2, 3. The pneumatic chamber 2 consists of two sheets of thermoplastic polyurethane 4, 5 welded around their periphery along a line 6. Internal walls 7, formed of sheets of thermoplastic polyurethane, are welded along their entire length to each face of the two thermoplastic polyurethane sheets 4, 5, internal to the pneumatic chamber 2.

[0063] The pneumatic chamber 3 consists of two sheets of thermoplastic polyurethane 5, 8 welded to the periphery of the thermoplastic polyurethane sheet 8 which is lower than that of the thermoplastic polyurethane sheet 5. Internal walls 9, formed of sheets of thermoplastic polyurethane, are welded along their entire length to each of the faces of the two thermoplastic polyurethane sheets 5, 8, internal to the pneumatic chamber 2.

[0064] Thermoplastic polyurethane sheets are marketed under the name TUFTANE® TFL-1E and have a secant elongation modulus of 9.8 MPa at 10% elongation.

[0065] Figure 2 illustrates the support device for a human body 1 seen from above. In this figure 2, the thermoplastic polyurethane sheet 8 is shown superimposed on the thermoplastic polyurethane sheet 5.

[0066] During use, the pneumatic chamber 2 is maintained at a pressure to ensure a height hl for the head support device of a human body 1, while the pneumatic chamber 3 remains deflated. When the pneumatic chamber 3 is also maintained at a pressure, the head support device of a human body 1 has a height h2, with the head of the human body resting on the pneumatic chamber 2.

[0067] The head support device of a human body 1 can thus, for example, be adapted to different types of human bodies that may have different body sizes.

[0068] The pressurization of each of the pneumatic chambers 2 and 3 is achieved via valves, not shown in the figures, fitted to each of the pneumatic chambers. Each valve can be located at the end of a tube connected to one of the pneumatic chambers, ensuring easy access for inflation to the desired pressure under load. These valves, or the tubes connecting them, are designed to avoid contact with the head.

[0069] Figure 3 illustrates a schematic representation of a second example of a head support device for a human body 21. The head support device for a human body 21 comprises two superimposed pneumatic chambers 22, 23. The pneumatic chamber 22 is made of two sheets of thermoplastic polyurethane. 24, 25 welded at their periphery by means of a third sheet of thermoplastic polyurethane 26 forming a vertical wall and giving the pneumatic chamber 22 the appearance of a mattress. Internal walls 27, formed of sheets of thermoplastic polyurethane, are welded along their entire length to each of the faces of the two thermoplastic polyurethane sheets 24, 25, internal to the pneumatic chamber 22.

[0070] The pneumatic chamber 23 is made of two thermoplastic polyurethane sheets 25, 28 welded to the periphery of the thermoplastic polyurethane sheet 28, which is lower than that of the thermoplastic polyurethane sheet 25, by means of a third sheet of thermoplastic polyurethane 29 forming a vertical wall and giving the pneumatic chamber 23 the appearance of a mattress. Internal walls 30, formed of sheets of thermoplastic polyurethane, are welded along their entire length to each of the faces of the two thermoplastic polyurethane sheets 25, 28, internal to the pneumatic chamber 23.

[0071] As in the case of device 1, the thermoplastic polyurethane sheets are marketed under the name TUFTANE® TFL-1E and have a secant elongation modulus of 9.8 MPa at 10% elongation.

[0072] Figure 4 illustrates the support device for a human body 21 seen from above. In this figure 4, the thermoplastic polyurethane sheet 28 is shown, which is superimposed on the thermoplastic polyurethane sheet 25.

[0073] During use, the pneumatic chamber 22 is maintained at a pressure to ensure a height h21 for the head support device of a human body 21, while the pneumatic chamber 23 remains deflated. When the pneumatic chamber 23 is also maintained at a pressure, the head support device of a human body 21 has a height h22, with the head of the human body resting on the pneumatic chamber 23.

[0074] As in the previous case when using the support device 21, it is therefore possible to adapt the height of the head support device to a human body 21.

[0075] Tests were carried out with a support device as shown in Figures 1 and 2.

[0076] Before its installation, the support device is partially filled with inflation gas in order to separate the walls of the pneumatic chambers.

[0077] The support device is put in place and the two pneumatic chambers 2 and 3 are brought to and maintained at the desired pressures under load.

[0078] The tests carried out showed that the support device according to the invention allows greater stability than that which would be provided by an air cushion consisting of a single air chamber allowing the same height to be ensured.

[0079] The pressure of the pneumatic chamber 3, on which the head rests, can be further defined for optimal support, thereby reducing the risk of pressure ulcers by ensuring stable pneumatic support at the desired height. The pressure of the pneumatic chamber 3 under load is then advantageously less than 20 mmHg.

[0080] The examples presented should not be interpreted as an exhaustive list. The forms of the devices can vary, as can their methods of implementation. may be different and the number of pneumatic chambers in a device may be greater.

Claims

DEMANDS 1 - A device for supporting the head of a human body in a supine position on a horizontal plane, characterized in that said device consists of at least two pneumatic chambers superimposed in the vertical direction, in that said at least two pneumatic chambers are linked in a non-removable manner, in that said at least two chambers are made of at least two sheets of thermoplastic polymer, in that one of said at least two sheets of thermoplastic polymer is common to said at least two pneumatic chambers,in that at least one of said at least two pneumatic chambers is made up of at least two sheets of thermoplastic polymer connected at their periphery and at least one substantially vertical wall made up of a sheet of thermoplastic polymer welded along its length to each of the internal surfaces of two of said at least two sheets of thermoplastic polymer, and in that at least the pneumatic chamber resting on the horizontal plane is kept under pressure. 2- Human head support device, according to claim 1, characterized in that at least one pneumatic chamber of the human head support device is made up of at least two thermoplastic polymer sheets heat-welded edge to edge at their periphery. 3- Human head support device, according to claim 1, characterized in that at least one pneumatic chamber of the human head support device is made up of at least three sheets of thermoplastic polymer, in that two sheets of thermoplastic polymer are connected at their periphery by a third sheet of thermoplastic polymer forming a vertical wall, and in that said third sheet of thermoplastic polymer is heat-welded at the periphery of the first two sheets of thermoplastic polymer. 4- A device for supporting the head of a human body, according to any one of claims 1 to 3, characterized in that each of the pneumatic chambers has an inflation orifice. 5- A head support device for a human body, according to any one of claims 1 to 4, characterized in that the device comprises at least one detachable pneumatic chamber. 6- A head support device for a human body according to claim 5, characterized in that said at least one detachable pneumatic chamber is associated with at least one other pneumatic chamber by means of connection. 7- A head support device for a human body according to any one of claims 1 to 6, characterized in that at least a part of the surface of said device coming into contact with the head of a human body is covered with a "3D spacer" fabric.

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