阅读说明：本技术 其型面设有突出的固定元件 (With projecting fixing elements on the profile ) 是由 S·库皮尔斯 西蒙·德·格如体尔 于 2019-01-24 设计创作，主要内容包括：用于制造用于将患者身体部位固定在支撑面上的固定元件(1)的方法,其中,固定元件(1)包括由热塑性材料制成以用于接收要固定的身体部位的板(8)和用于将固定元件(1)固定至支撑面的至少一个型面(3),其中,型面(3)包括用于将型面(3)固定至板(8)的第一固定装置,其中,固定装置包括由第一接触面(6)和与第一接触面(6)相对的第二接触面(7)界定的凹槽(9),其中,凹槽(9)接收板(8),以便使第一和第二接触面(6、7)沿着板(8)放置,并且其中,第一接触面(6)和第二接触面(7)中的至少一个设有至少一个突出(10),其中,突出(10)在板(8)的厚度方向上穿入由热塑性材料制成的板(8)中,以将由热塑性材料制成的板(8)锚定在凹槽(9)内。(Method for manufacturing a fixation element (1) for fixing a body part of a patient on a support surface, wherein the fixation element (1) comprises a plate (8) made of a thermoplastic material for receiving the body part to be fixed and at least one profiled surface (3) for fixing the fixation element (1) to the support surface, wherein the profiled surface (3) comprises first fixation means for fixing the profiled surface (3) to the plate (8), wherein the fixation means comprise a groove (9) delimited by a first contact surface (6) and a second contact surface (7) opposite the first contact surface (6), wherein the groove (9) receives the plate (8) in order to place the first and second contact surfaces (6, 7) along the plate (8), and wherein at least one of the first contact surface (6) and the second contact surface (7) is provided with at least one protrusion (10), wherein the protrusion (10) penetrates into the sheet (8) of thermoplastic material in the thickness direction of the sheet (8) to anchor the sheet (8) of thermoplastic material within the groove (9).)

1. Method for producing a fixing element (1) for fixing a body part of a patient to a support surface (2), wherein the method comprises the following steps:

-providing a plate (8) made of thermoplastic material for receiving a body part to be immobilized;

-providing a profiled surface (3) comprising, on a first side, first fixing means (4) for fixing the profiled surface (3) to the panel (8) and, on a second side, different from the first side, second fixing means (5) for releasably fixing the profiled surface (3) to the support surface (2), wherein the first fixing means (4) comprise a recess (9) delimited by a first contact surface (6) and a second contact surface (7) opposite to the first contact surface (6) for receiving the panel (8) made of thermoplastic material,

-placing the plate (8) made of thermoplastic material in the recess (9) of the first fixing means (4) so as to place the first and second contact surfaces (6, 7) along the plate (8);

-forming at least one protrusion (10) in at least one of said first contact surface (6) and said second contact surface (7) so as to make said protrusion (10) penetrate into said sheet made of thermoplastic material (8) to anchor said sheet made of thermoplastic material (8) within said groove (9).

2. Method for manufacturing a fixing element (1) according to the preceding claim, wherein said steps are consecutive steps.

3. Method for manufacturing a fixation element (1) according to one of the preceding claims 1-2, wherein the step of forming at least one protrusion (10) into at least one of the first and second contact surfaces (6, 7) is performed by pressing a mould (11) and the mould surface (3) such that the mould surface (3) is plastically deformed forming the first and second contact surfaces (6, 7) provided with at least one protrusion (10).

4. Method for manufacturing a fixing element (1) according to the preceding claim, wherein the mould (11) is provided with mould teeth (12) pressing the at least one protrusion (10) into the mould surface (3).

5. Fixing element (1) for fixing a body part of a patient on a support surface (2), wherein the fixing element (1) comprises a plate (8) made of a thermoplastic material for receiving the body part to be fixed and at least one profiled surface (3) for fixing the fixing element (1) to the support surface (2), wherein the profiled surface (3) comprises a first fixing means (4) for fixing the profiled surface (3) to the plate (8) on a first side and a second fixing means (5) for releasably fixing the profiled surface (3) to the support surface (2) on a second side different from the first side, wherein the first fixing means (4) comprises a recess (9) delimited by a first contact surface (6) and a second contact surface (7) opposite to the first contact surface (6), wherein the recess (9) receives the plate (8) such that the first and second contact surfaces (6, 7) lie along the plate (8), characterized in that at least one of the first contact surface (6) and the second contact surface (7) is provided with at least one protrusion (10), wherein the protrusion (10) penetrates into the plate (8) made of thermoplastic material in the thickness direction of the plate (8) to anchor the plate (8) made of thermoplastic material within the recess (9).

6. The fixing element (1) according to the preceding claim, wherein the plate (8) made of thermoplastic material is anchored within the groove (9) mainly by clamping the plate (8) with the at least one protrusion (10).

7. Fixing element (1) according to one of the preceding claims 5-6, wherein the protrusion (10) penetrates into the plate (8) of thermoplastic material in the thickness direction of the plate (8), but only partially.

8. The fixation element (1) according to any one of the preceding claims 5-7, wherein at least one of the first contact surface (6) and the second contact surface (7) is provided with a set of protrusions (10).

9. The fixing element (1) according to any of the preceding claims 5-8, wherein the set of protrusions (10) comprises at least one row of protrusions, wherein the centre point of the cross-section of the protrusions (10) within the at least one row of protrusions is arranged to lie substantially on the same line with the contact surface (6, 7) provided with the protrusions (10), preferably directed in the longitudinal direction of the groove (9).

10. The fixing element (1) according to the preceding claim, wherein the set of protrusions (10) comprises a first row of protrusions and at least one further second row of protrusions, wherein the first row of protrusions and the further second row of protrusions are parallel to each other.

11. The fixing element (1) according to one of the preceding claims 9-10, wherein the centre point of the cross-section of each protrusion (10) in at least one row of protrusions on the contact surface (6, 7) provided with the at least one row of protrusions (10) is at an inter-protrusion distance from the centre point of at least one adjacent protrusion (10) in the row of protrusions, and wherein the inter-protrusion distance of each protrusion (10) in the at least one row of protrusions is approximately equal, thereby forming a regular row.

12. The fixing element (1) according to the preceding claim in combination with at least claim 10, wherein the first row of projections and the at least one further second row of projections of the set of projections (10) are regular rows having the same inter-projection distance and being offset with respect to each other along the longitudinal direction of the rows by a distance which is smaller than the inter-projection distance of the rows.

13. The fixing element (1) according to any of the preceding claims 5 to 12, wherein both the first contact surface (6) and the second contact surface (7) are provided with at least one protrusion (10).

14. The fixing element (1) according to the preceding claim, wherein the first contact surface (6) and the second contact surface (7) are each provided with a set of protrusions (10).

15. The fixing element (1) according to the preceding claim in combination with at least claim 11, wherein a set of protrusions (10) provided on the first contact surface (6) and a set of protrusions (10) provided on the second contact surface (7) both form at least one regular row having the same inter-protrusion distance, and wherein the at least one regular row of protrusions provided on the first contact surface (6) and the at least one regular row of protrusions provided on the second contact surface (7) are parallel to each other.

16. The fixing element (1) according to the preceding claim, wherein the at least one regular row of protrusions of the set of protrusions (10) provided on the first contact face (6) and the at least one regular row of protrusions of the set of protrusions (10) provided on the second contact face (7) are offset with respect to each other along the longitudinal direction of the row by a distance which is smaller than the inter-protrusion distance of the row.

17. The immobilization element (1) according to any of the preceding claims 5-16, wherein the plate (8) made of thermoplastic material for receiving a body part to be immobilized is selected from the group comprising: thermoplastic elastomers, thermoplastic polyurethanes, thermoplastic polyisoprenes, thermoplastic polyesters, thermoplastic polyolefins, polyvinyl chlorides, polystyrenes, or mixtures of two or more of these materials.

18. The immobilization element (1) according to any of the preceding claims 5-17, wherein the plate (8) made of thermoplastic material for receiving the body part to be immobilized has a deformation temperature between 65 ℃ and 70 ℃, wherein the deformation temperature refers to the temperature when the plate (8) is pulled onto the body part to be immobilized, such that the shape of the body part to be immobilized is maintained after cooling of the plate (8) made of thermoplastic material.

19. Use of a fixing element (1) according to one of the preceding claims 5 to 18,

wherein the fixing element (1) is heated;

wherein the sheet (8) made of thermoplastic material is pulled onto the body part to be immobilized, and

wherein, after cooling, the sheet (8) made of thermoplastic material retains the shape of the body part to be immobilized.

20. Use of a fixing element (1) according to the preceding claim, wherein the fixing element (1) retains the shape of the body part to be fixed after cooling of the plate (8) made of thermoplastic material for fixing the patient's body part on the support surface (2).

21. Use of a fixation element (1) according to the preceding claim for radiotherapy, such as photon therapy.

22. Use of a fixing element (1) according to the preceding claim as a fixing mask for fixing a patient's head on the support face (2).

23. Machine for carrying out the method according to any one of the preceding claims 1-4, comprising:

-clamping means (13) for receiving the profiled surface (3) and the plate (8);

-a die (11) provided with die teeth (12) for pressing at least one protrusion (10) under pressure into the moulding surface (3); and

-pressing means (14) for pressing said moulding surface (3) and said mould (11) so as to elastically deform said moulding surface (3) forming said first and second contact surfaces (6, 7) provided with said at least one protrusion (10).

24. The machine of the preceding claim, wherein the mould (11) is replaceable.

Technical Field

The invention relates to a fixing element for fixing a body part of a patient to a support surface, as described in the preamble of the first claim. More particularly, the invention relates to the anchoring of the profile of the fixing element and the plate made of thermoplastic material. The invention also relates to the use of the fixing element, a method for manufacturing the fixing element and a machine for performing the method.

Background

Disclosure of Invention

The object of the present invention is to provide a method for manufacturing a fixing element with which the above-mentioned problems are solved. More specifically, it is an object of the invention to provide a method for manufacturing a fixing element which still has a better connection under the tension created between the plate and the profile of the fixing element. To this end, the invention provides a method comprising the steps of:

providing a plate made of thermoplastic material for receiving a body part to be immobilized;

providing a profiled surface comprising, at a first side, first fixing means for fixing the profiled surface to a panel and, at a second side different from the first side, second fixing means for releasably fixing the profiled surface to a support surface, wherein the first fixing means comprise a recess delimited by a first contact surface and a second contact surface opposite the first contact surface, the recess being for receiving a panel made of thermoplastic material,

placing a plate made of thermoplastic material in the recess of the first fixture so that the first contact surface and the second contact surface are placed along the plate;

forming at least one protrusion in at least one of the first contact surface and the second contact surface, so as to penetrate the protrusion into the plate made of thermoplastic material, to anchor the plate made of thermoplastic material within the groove.

The invention has the following advantages: by forming at least one protrusion in at least one of the first contact surface and the second contact surface, the sheet of thermoplastic material is anchored in the recess of the mould surface, so that the sheet of thermoplastic material can be attached to the mould surface in a stable and secure manner. For example, the method provides a profile that enables a panel to be securely and stably attached thereto for an extended period of time. The fixing element obtained according to the method of the invention is resistant to the tensions that are generated between the plate and the profile during the initial pulling of the plate onto the body part to be fixed and during the movement of the patient during the treatment. However, when moving the patient during immobilization of the body part and thus the body part to be immobilized, a large tension is created between the mould surface and the anchored plate, which tension tries to pull the plate out of the mould surface. In the fixing element obtained by the method according to the invention, the risk of the sheet in the groove of the profile tearing, deforming or falling off under tension is reduced. The fixing element obtained according to the method of the invention therefore has the following advantages: the body part to be immobilized can be positioned and immobilized on the support surface in an accurate and reliable manner. For example, during the course of treatment, the body part can be repeatedly positioned and fixed with little change in the fixed position. A secondary advantage of the invention is that the anchoring of the plate in the groove of the profile is not affected by environmental factors such as a humid environment, whereby the anchoring can be kept stable for a long time.

A secondary advantage of the invention is that no auxiliary material is required to clamp the plate in the recess of the mould surface, thereby saving costs, which are for example necessary for purchasing anchoring elements such as screws. Furthermore, the fixing element obtained by the method according to the invention is not affected in use by secondary fixing materials which may affect the function of the fixing element. Thus, for example, the at least one protrusion exerts little effect on electromagnetic radiation (e.g., X-rays, gamma rays, electron and proton beams, and ultrasound waves used during radiation therapy or during medical diagnosis). This effect is for example obtained by the homogeneous material properties of the other parts of the at least one protrusion and the mould surface, e.g. the other parts of the at least one protrusion and the mould surface are made of the same material and thus consist of the same particles having the same proton mass. A secondary advantage of the method according to the invention is that the production of the fastening element by means of the at least one projecting clamping plate is a time-saving and cost-effective method, since there is no need to provide the fastening element separately, for example: applying an adhesive, wherein the adhesive must be hardened before the fixing element is used, or for example: the plate is anchored in the groove by ultrasonic welding, which necessitates the procurement of expensive equipment. A secondary advantage of the invention is that the fixing element can be manufactured before the fixing element is used, because the fixing element can be used directly after the panel has been clamped in the groove of the profile by means of the at least one projection, which is for example completely different from the method of anchoring the panel in the groove by means of the adhesive, in which method the fixing element must be used until the adhesive has completely set. Thus, the fixation element may be manufactured on-site, e.g. before the fixation element is used to fix the patient's body part on the support surface. Thus, the mould surface and the plate made of thermoplastic material can be stored separately by the user of the fixing element, which makes the packaging and storage more compact, for example. More compact packaging and storage means: for example, the production and use process is more environmentally friendly and economically advantageous, for example because the fixing element can be transported more efficiently, and for example because a smaller number of packages have to be used. Furthermore, this means that the user of the fixing element can firstly store on site a batch of plates of various sizes (for example a child or a fat person) and types (for example a fixing mask or an arm splint), respectively, and secondly a batch of different types of profiles, for example according to the type of support surface. The user can then determine on site which type of plate should be anchored on which type of profile, depending on the patient and the body part to be fixated, so that the user does not have to stock in advance the exact plate and profile combination.

In one embodiment of the invention, the steps involved in the method for manufacturing the fixation element are consecutive steps. This has the following advantages: the protrusions are formed when the plate is placed in the grooves of the mould surface, whereby a better anchorage of the plate in the grooves is obtained. More specifically, in this embodiment the profiled surface may be made of a rigid material, but it is not necessary to pull the contact surfaces apart to place the plate in the recess, which is necessary if the contact surfaces are already provided with protrusions. The firm connection between the panels and the mould surface is partly due to the use of projections to form the rivets. The inventors have found that forming at least one protrusion in at least one contact surface by deep drawing a small portion of the contact surface results in a protrusion having a thin wall and a relatively thick head. Thus, the resulting protrusion has a relatively stiff and rigid protrusion head as compared to the relatively soft protrusion wall. The sheet made of thermoplastic material is elastically stretched by the protruding penetration, whereby the sheet will have a tendency to spring back elastically. Because the projecting walls are relatively flexible compared to the projecting heads, the panel is elastically sprung back by compression of the projecting walls. Thus, at least a portion of the plate is sandwiched between the protruding head and the contact surface, thereby forming a rivet joint.

In one embodiment of the method according to the invention, the step of forming at least one protrusion in at least one of the first contact surface and the second contact surface is performed by pressing the mould and the mould surface together, for example by pressing the mould around the mould surface, such that the mould surface can be plastically deformed until the first contact surface and the second contact surface are provided with at least one protrusion. In one embodiment of the method of the invention, the mould is provided with teeth or pins which press at least one protrusion into the mould surface. The embodiment in which the protrusions are formed by pressing the mould and the mould surface has the following advantages: repeatable results are obtained because each profile is compressed in the same manner using the same die.

Furthermore, the invention provides a fixing element, wherein at least one of the first and second contact surfaces of the profiled surface is provided with at least one projection, wherein the projection penetrates into the plate made of thermoplastic material in the thickness direction of the plate to anchor the plate made of thermoplastic material within the groove. Preferably, the invention provides a fixing element obtained by carrying out the method. The invention has the following advantages: by providing at least one protrusion in at least one of the first contact surface and the second contact surface, the sheet made of thermoplastic material is anchored in the recess of the mould surface, so that the sheet made of thermoplastic material can be attached to the mould surface in a stable and firm manner for a long time. For example, the profile can resist separation of the sheet from the grooves of the profile.

In one embodiment of the invention, the plate made of thermoplastic material is anchored in the recess mainly by clamping the plate with at least one protrusion. This embodiment shows that no auxiliary fixing means are required for anchoring the plate in the groove of the profile. Since the anchoring takes place in fact by clamping the plate in the recess by means of the projections penetrating into the plate, there is no need to use secondary material, which does not increase the cost, extend the manufacturing time and hinder the use. The term "penetrating" of the projection into the plate means that the projection forms a depression in the plate relative to a point where no projection is provided, whereby, for example, the frictional resistance between the plate and the contact surface is increased, and/or whereby, for example, the plate is clamped onto the projection, and/or whereby, for example, the projection forms a rivet joint.

In one embodiment of the invention, the groove has an elongation direction (in the following referred to as the longitudinal direction of the groove), a shorter transverse direction substantially perpendicular to the contact surface and a depth direction perpendicular to the longitudinal and transverse directions of the groove. In one embodiment of the invention, the width of the groove, measured in the transverse direction of the groove, is substantially constant throughout the groove. In one embodiment of the invention, the width of the groove, measured in the transverse direction of the groove, is between 1mm and 5 mm. In one embodiment of the invention, the plate made of thermoplastic material in the groove has a thickness d1 in the thickness direction of the plate. More specifically, the plastic plate in the groove has a thickness dl without protrusions in the plate. More specifically, the plastic plate in the recess has a thickness dl before the plate is deformed over the body part to be immobilized. In one embodiment of the invention, the thickness dl of the plate is between 0.5mm and 5.0 mm. In one embodiment of the invention, the width of the groove is greater than the thickness dl of the plate within the groove. This has the following advantages: the thermoplastic sheet can be installed simply, quickly, and manually during manufacture. In an alternative embodiment of the invention, the width of the groove is equal to the thickness dl of the plate in the groove, for example because the contact face of the groove presses against the plate, thereby making the thickness of the plate outside the groove greater than or equal to the thickness dl of the plate in the groove. An advantage of this embodiment is that the plate made of thermoplastic material can be anchored more firmly in the recess, for example by friction forces generated between the contact surface and the plate by protruding the clamping plate.

In one embodiment of the invention, the recess of the mould surface is delimited by a first wall and an opposite second wall, while a first contact surface and a second contact surface form part of the first wall and the second wall, respectively, wherein the contact surfaces are part of the walls placed along a plate made of thermoplastic material. In one embodiment of the invention, the first wall and the second wall of the recess are integrally connected together, for example because the first wall and the second wall are constituted by the same component, for example they are formed by folding one sheet or by an injection moulding process or an extrusion process. In an alternative embodiment, the first and second walls of the recess are not integrally connected together, e.g. one of the two walls of the recess is releasably connected to the other wall. The two walls have the following advantages when they are integrally connected to each other: the recess of the profile is integrally formed, which avoids weak points in the profile and, for example, reduces the risk of the two walls accidentally separating during use of the fixing element. Providing two releasable walls has the following advantages: the plate can be easily removed from the recess, which can simplify, for example, the recovery of the plate or the profile after the use of the fixing element. In one embodiment of the invention, the thickness of the wall is between lmm and 5 mm. Providing a wall having a given thickness has the following advantages: during the formation of the projections, for example during deep-drawing of the projections, the projection walls become thinner and more flexible, so that a rivet connection can be formed. Providing a thicker wall may initially result in a protrusion of the relatively rigid protrusion wall, making it difficult to form the rivet, for example because the panel cannot spring back sufficiently strongly, and thus cannot press the rigid protrusion wall sufficiently inward. Providing thinner walls may initially result in the projection having projection walls that are too soft, for example which in turn may result in less accurate riveting, for example because under tension the projection walls may move more than a limited distance in the direction of the tension. In one embodiment of the invention, the thickness of the projecting wall is adapted to the thickness of the plate; preferably, the thickness of the protruding wall is proportional to the thickness of the plate, so that after deep-drawing the protrusion to thin the protruding wall, a sufficiently thick and thus rigid protruding wall is obtained. In one embodiment of the invention, the thickness of the wall is 2mm if the thickness dl of the plate is 2mm, and a thicker wall is provided if a thicker plate is provided. Providing a thicker wall when providing a thicker plate has the following advantages: when forming the protrusion by deep-drawing the wall, sufficient but limited flexibility is given to the protruding wall to enable a firm rivet to be formed. However, providing thicker plates initially requires stretching the walls deeper, thus forming thinner and less rigid projecting walls.

In one embodiment of the invention, the protrusion protrudes from the contact surface on which it is provided by a maximum height h 1. In one embodiment, the height h1 is less than the thickness d1 of the plate. Because the height of the projection projecting from the contact surface is less than the thickness of the plate, the projection cannot drill through the plate. More specifically, this embodiment provides at least one protrusion that penetrates in the thickness direction of the plate but only partially penetrates into the plate made of thermoplastic material. This has the following advantages: the tension is supported by a larger area of thermoplastic material. This has the following advantages: the risk of tearing or accidental deformation of the sheet within the groove of the profile is reduced. In an alternative embodiment, the height h1 of the protrusion is greater than the thickness d1 of the plate, but the protrusion only penetrates partially into the plate. This can be achieved, for example, because the contact surface opposite to the contact surface provided with the projection is deformed during the formation of the projection, and because the plate is deformed in a fleece-like manner and is sandwiched between the projection and the opposite contact surface. Preferably, the method is arranged for forming a protrusion having a height h 1. Preferably, the method for manufacturing a fixing element provides a mould with teeth having a respective height greater than h1, more particularly at least the sum of the height h1 and the thickness of the walls of the groove of the moulding surface. In one embodiment of the invention, the ratio of the maximum height h1 of the protrusions to the thickness d1 of the plate is between 0.5 and 1.25, more preferably between 0.8 and 1.25. The inventors have found that by these proportions, optimum stability is achieved when anchoring the plate in the recess. A higher proportion of fixing elements will result in a higher risk of tearing and accidental deformation of the sheet, while a lower proportion of fixing elements will result in a higher risk of the sheet falling out of the groove of the profile. Preferably, the method is arranged for forming a protrusion having a height h 1.

In one embodiment of the invention, at least one of the first contact surface and the second contact surface has at least one protrusion which penetrates in the thickness direction of the plate but only partially penetrates into the plate made of thermoplastic material to provide a fleece-like thermoplastic material between the protrusion and the contact surface. In one embodiment of the invention, the fleece material has a minimum thickness that is not pierced by the protrusions. Preferably, the ratio of the minimum thickness of the fleece material to the thickness d1 of the plate is between 0.0001 and 0.5, preferably between 0.0001 and 0.2. Preferably, the ratio of the minimum thickness of the fleece material to the width of the groove is between 0.0001 and 0.5, preferably between 0.0001 and 0.2. Preferably, the method is provided for forming a protrusion that penetrates, but only partially penetrates, into a plate made of thermoplastic material. Preferably, the method is arranged for forming a fleece-like thermoplastic material. This embodiment has the advantage that the plate made of thermoplastic material deforms under pressure, forming a fleece-like thermoplastic material between the protrusions and the opposing contact surfaces, and thus better clamping the plate in the groove. Without being bound by a theory, a better clamping effect can be achieved, for example by the flow of the plate made of thermoplastic material under increased pressure, whereby after the pressure is removed, the plate made of thermoplastic material forms a stable and high friction adhesive layer between the protrusions and the opposing contact surfaces, which firmly anchors the plate in the recess. Furthermore, the large deformation of the plate ensures a blocking of the non-stick layer applied to the plate made of thermoplastic material for example to prevent the plates from sticking to each other during storage, thereby improving the bonding properties of the fleece-like thermoplastic material.

In one embodiment of the invention, the contact surface opposite to the contact surface provided with at least one protrusion has at least one protrusion opposite to the at least one protrusion, wherein the protrusion is directed away from the plate. More specifically, the protrusions are oriented in the same direction as the opposing protrusions. In one embodiment of the invention, the protrusions and the protuberances have an almost symmetrical, e.g. congruent, shape. In one embodiment of the invention, the height h1 of the protrusion is less than the width of the groove. In an alternative embodiment, the height h1 of the protrusion is greater than the thickness of the groove, and at least one wool-like plate is disposed between the protrusion and the protrusion. More generally, this embodiment provides at least one protrusion penetrating in the thickness direction of the plate but only partially into the plate made of thermoplastic material to provide a fleece-like thermoplastic material between the protrusion and the protrusion. Preferably, the method is arranged for forming the protrusions, for example by providing a die with die teeth of a suitable height, or by providing an adjustable depth means. More specifically, the method is provided for forming the protrusion during forming of the protrusion, for example by plastic deformation of a contact surface opposite to the contact surface provided with the protrusion during pressing of the mould with the mould surface. More specifically, during the compression of the mould with the mould surface, the pressure is transmitted from the first contact surface provided with the protrusions to the opposite contact surface by means of a plate made of thermoplastic material. This embodiment has the advantage that the plate made of thermoplastic material deforms under pressure, forming a fleece-like thermoplastic material between the protrusions and the protuberances, and thus better clamping the plate in the groove. Without being bound by a theory, a better clamping effect may be achieved, for example by the flow of the plate made of thermoplastic material under increased pressure, whereby after the pressure is removed, the plate made of thermoplastic material forms a stable adhesive layer between the protrusions and the protuberances, which firmly anchors the plate in the groove. Furthermore, this embodiment has the advantage that a user of the fixing element or a manufacturer of the fixing element can immediately visually determine whether the profile surface is provided with protrusions or whether all protrusions have been applied correctly, for example by visually determining the presence of protrusions on the contact surface. A secondary advantage is that the plate can be clamped more firmly in the groove of the profile.

In one embodiment of the invention, the protrusion has a longitudinal cross-section, in addition to a plane perpendicular to the contact surface on which the protrusion is provided, which is mainly in one of the following shapes: rectangular, at least a part of an oval, at least a part of a circle, triangular, trapezoidal and rectangular with a triangular notch in the side opposite to the side where the contact surface is located. In one embodiment of the invention, the protruding longitudinal section has the shape of a rectangle provided with a triangle or a semicircle at the top of the side opposite to the side where the contact surface is located. The choice of the shape of the longitudinal section can be chosen by the person skilled in the art, depending inter alia on the desired grip of the protrusion in the sheet made of thermoplastic material, the risk of the sheet tearing on any sharp edges of the protrusion, and the deformability of the profile material. Preferably, the method is arranged for forming a protruding cross-sectional shape.

In one embodiment of the invention, the protrusions have one of the following three-dimensional shapes: semi-bowl, bar, pyramid, cone, cylinder with conical indentations in the face opposite the contact surface, cylinder with partially or fully rounded ends. The choice of the three-dimensional shape of the protrusions may be chosen by the person skilled in the art, depending inter alia on the desired clamping of the protrusions in the sheet made of thermoplastic material, the risk of tearing of the sheet on sharp edges of the protrusions, and the deformability of the profile material. Preferably, the method is arranged for forming a protruding cross-sectional shape. Preferably, the method for producing the fixing element provides for this purpose a mold, the teeth of which have a corresponding shape.

In one embodiment of the invention, the protrusion is at least partially hollow, e.g. substantially hollow, e.g. provided with only edge faces delimiting the protrusion. Compared with a solid protrusion, the hollow protrusion has the following advantages: the weight of the profile can be reduced. Another advantage is that profiles provided with hollow protrusions have less influence on radiation, such as X-rays, gamma rays, electron beams, proton beams or ultrasound used during radiotherapy or during medical diagnostics, than do solid protrusions; for example because of the reduced material that absorbs, reflects and deflects these rays within the profile. In one embodiment of the invention, the protrusion is hollow and no edge surface is provided in the contact surface. This embodiment has the advantage that the user of the fixing element or the manufacturer of the fixing element can immediately visually determine whether the profile surface is provided with protrusions or whether all protrusions have been applied correctly, which is difficult to determine from inside the recess, because usually the width is not sufficient to make inspection difficult or whether a plate has been provided in the recess. Furthermore, the hollow protrusions are easier to manufacture than solid protrusions, for example by means of press protrusions, which may save manufacturing costs and time. Preferably, the method is arranged for forming the hollow protrusion, for example by plastic deformation of the contact surface.

In one embodiment of the invention, the at least one projection is made of the same material as the contact surface provided with the at least one projection. This embodiment has the following advantages: the protrusions do not substantially affect radiation, such as X-rays, gamma rays, electron beams, proton beams, or ultrasound used during radiation therapy or during medical diagnosis; this is for example because the at least one protrusion and the other part of the profile have homogeneous material properties, for example both being made of the same material and thus being composed of the same particles having the same proton mass. Preferably, the method of the invention is arranged for forming at least one protrusion in the same material as the contact surface by pressing the contact surface with a die provided with die teeth, so that the contact surface is plastically deformed to form the protrusion.

In one embodiment of the invention, the at least one protrusion is integral with the contact surface, e.g. connected to the contact surface. This embodiment emphasizes that the protrusion is formed by plastic deformation of the contact surface, such that the contact surface is integral with the protrusion. An advantage of this embodiment is that the risk of the protrusions being pulled off together with the sheet under tension between the profile and the sheet is reduced.

In one embodiment of the invention, at least one of the first contact surface and the second contact surface is provided with a set of protrusions. The provision of a set of protrusions has the advantage that the plate can be anchored better, for example in a more stable and powerful manner, in the groove of the profile. Preferably, the method is arranged for forming a set of projections on at least one of the contact surfaces, for example by providing a set of teeth on a mould tool.

In one embodiment of the invention, the set of protrusions comprises at least one row of protrusions, wherein the centre point of the cross-section of the protrusions within the at least one row of protrusions and the contact surface provided with the protrusions are arranged to be substantially on the same line, preferably directed in the longitudinal direction of the groove. The direction in which the straight lines of protrusions in the rows of protrusions are provided is referred to as the longitudinal direction of the rows. The advantage of having protruding rows is that the plate can be clamped in different directions, thereby achieving a better anchorage. The advantage of providing a row of protrusions directed in the longitudinal direction of the groove is that the tension on the plate is absorbed by the plurality of protrusions, thereby allowing the tension to be spread and reduced evenly over a larger surface area and thus reducing the risk of the plate tearing or falling off or being accidentally deformed. In one embodiment of the invention, the set of protrusions comprises a first row of protrusions and at least one further second row of protrusions. Preferably, the first row of projections and the at least one further second row of projections are parallel to each other. The advantage of providing at least two rows of protrusions parallel to each other is that the plates can be better anchored in the grooves of the profile, for example because the friction between the plates and the profile increases. Preferably, the method is arranged for forming at least one row of protrusions. Preferably, the method for producing the fastening element provides for this purpose at least one die provided with at least one row of die teeth.

In one embodiment of the invention, the centre point of the cross-section of each protrusion provided in at least one row of protrusions on a contact surface provided with at least one row of protrusions (hereinafter referred to as the transverse cross-section of the protrusion in the contact surface) is at an inward protrusion distance from the centre point of at least one adjacent protrusion in the row of protrusions. In one embodiment of the invention, the inter-projection spacing between each projection in at least one row of projections is substantially equal, thereby forming a regular row. The advantage of providing at least one regular row, for example directed in the longitudinal direction of the groove, is that the tension on the panel is absorbed by the plurality of protrusions and is evenly distributed, thereby distributing the tension more evenly over a larger area and thus reducing the risk of the panel tearing or falling off or being accidentally deformed. Preferably, the method is arranged for forming at least one regular projection row.

In one embodiment of the invention, the first row of protrusions and the at least one further second row of protrusions of a set of protrusions are regular rows and have the same inter-protrusion spacing. In one embodiment of the invention, the two regular rows are parallel to each other. In one embodiment of the invention, at least two regular rows are offset with respect to each other in the longitudinal direction of the rows by a distance which is smaller than the distance of the inward projections of the rows. The advantage of having at least two regular rows is that the plate can be better anchored in the groove of the profile. Furthermore, the first regular row of projections penetrates in turn in the longitudinal direction of the contact surface into the sheet made of thermoplastic material with at least one further second regular row of projections, thereby spreading the tensile forces more uniformly within the sheet. Preferably, the method is arranged for forming two regular rows of projections offset from each other, for example by providing the mould with corresponding teeth.

In one embodiment of the invention, the first contact surface and the second contact surface are each provided with at least one protrusion. The provision of at least one projection on both the first contact surface and the second contact surface has the advantage that the plate is better anchored in the groove of the profile. Preferably, the method is arranged for forming protrusions on both contact surfaces. Preferably, the method for manufacturing the fixing element provides for this purpose a die apparatus equipped with counter dies provided with die teeth.

In one embodiment of the invention, both the first contact surface and the second contact surface are provided with a set of protrusions. This provides the following advantages: the plate can be better anchored in the groove of the profile. Furthermore, this provides another advantage: there is more opportunity to obtain a straight profile after the formation of the protrusion, since both contact surfaces are deformed to form the protrusion. Preferably, the method is arranged for forming a set of protrusions on both contact surfaces, for example by providing a corresponding set of die teeth on both dies of the die apparatus.

In one embodiment of the invention, at least some of the set of protrusions provided on the first contact surface and at least some of the set of protrusions provided on the second contact surface are located at an extension of each other, thereby forming overlapping protrusions. This has the following advantages: during the formation of the protrusions, the sheet made of thermoplastic material is compressed between the overlapping protrusions, which may ensure a better adhesion between the protrusions and the sheet made of thermoplastic material, e.g. a higher friction. For example, the compression may cause local heating and plasticization of the sheet made of thermoplastic material between the overlapping protrusions, whereby the material more easily encapsulates and bonds with the protrusions, e.g. when the thermoplastic material cools and hardens. Preferably, the method is arranged for forming the overlapping projections on both contact surfaces, for example by providing both dies of the die apparatus with overlapping die teeth. This has another advantage: the projections can be formed in a simple manner, since the pressing of the mould with the contact surfaces does not lead to a folding of the sheet of thermoplastic material between the non-overlapping projections. In one embodiment of the invention, the plate made of thermoplastic material in the groove has a thickness d1 in the thickness direction of the plate, while the maximum height of the overlapping projections of the first contact surface and the second contact surface, relative to the contact surface provided with the projections, is h2 and h3, respectively, and the height h2+ h3 is smaller than said thickness d 1. More specifically, the plate in the groove has a thickness dl without providing a protruding point in the plate. Because the overlapping projections project together from the contact surface to a height less than the thickness of the plate, the projections cannot drill through the plate. This has the following advantages: the tensile forces are absorbed by a larger area of the thermoplastic material. This has the following advantages: the risk of tearing or accidental deformation or detachment of the sheet within the groove of the profile is reduced. Preferably, the method is arranged for forming overlapping protrusions of respective maximum heights h2 and h 3. In one embodiment of the invention, the ratio of the height h2+ h3 of the overlapping protrusions in a set of protrusions to the thickness d1 of the plate made of thermoplastic material is between 0.5 and 0.999, preferably between 0.8 and 0.999. The inventors have found that by this ratio an optimum anchoring is achieved when anchoring the plate into the groove. A larger proportion reduces the risk of the plate falling out of the groove partly because of the increased frictional resistance between the plate and the groove of the profile, but in turn increases the risk of the plate deforming and tearing partly because of the reduced remaining cross-sectional area in the plate during the extension of the projection. A smaller ratio reduces the risk of tearing and deformation of the sheet, but in turn increases the risk of the sheet falling out of the groove of the profile. Preferably, the method is arranged for forming the overlapping protrusions with a specific height ratio.

In an alternative embodiment of the invention, at least some, e.g. all, of the protrusions provided on the first contact surface and at least some, e.g. all, of the protrusions provided on the second contact surface are not overlapping protrusions, e.g. belonging to non-overlapping protrusions. This has the following advantages: the protrusions of the set of protrusions provided on the first and second contact surfaces may form protrusions on the respective opposing second and first contact surfaces. Preferably, the method is arranged for forming the non-overlapping projections, for example by providing non-overlapping teeth on two opposing dies.

In one embodiment of the invention, the set of protrusions provided on the first contact surface and the set of protrusions provided on the second contact surface form at least one regular row. In one embodiment of the invention, at least one regular row on the first contact surface and on the second contact surface has the same distance between the protrusions. In one embodiment of the invention, the at least one regular projection row provided on the first contact surface and the at least one regular projection row provided on the second contact surface are parallel to each other, for example in the longitudinal direction of the groove. In one embodiment of the invention, at least one regular row of protrusions of the set of protrusions arranged on the first contact surface and at least one regular row of protrusions of the set of protrusions arranged on the second contact surface are offset with respect to each other in the longitudinal direction of the rows by a distance which is smaller than the distance between the protrusions of the rows. The advantages of these embodiments are: a more uniform spreading of the tension on the sheet made of thermoplastic material is achieved, avoiding deformations or tears due to excessive concentrations of stress. Preferably, the method is arranged for forming at least one regular projecting row on both contact surfaces, for example by providing two dies of the die apparatus with respective regular rows of die teeth.

In one embodiment of the invention, the material used for the plate made of thermoplastic material for receiving the body part to be immobilized is selected from the group comprising: thermoplastic elastomers, thermoplastic polyurethanes, thermoplastic polyisoprenes, thermoplastic polyesters, thermoplastic polyolefins, polyvinyl chlorides, polystyrenes or mixtures of two or more of these materials. In one embodiment of the invention, the deformation temperature of the plate made of thermoplastic material for receiving the body part to be immobilized is between 65 ℃ and 70 ℃, wherein the deformation temperature refers to the temperature at which the plate is pulled onto the body part to be immobilized, such that the shape of the body part to be immobilized is maintained after cooling of the plate made of thermoplastic material. The advantage of the materials used in these embodiments is that they are easily deformable at the deformation temperatures that can be tolerated by the patient's skin, so that the initial deformation of the plate can be achieved by stretching it onto the body part of the patient to be fastened in as comfortable a manner as possible. Furthermore, these materials may provide the desired spring force to the plate when forming the protrusions, for example to form a rivet and/or to form a fleece-like thermoplastic material that is extruded around the protrusions.

In one embodiment of the invention, the at least one protrusion clamps the sheet at the deformation temperature with a clamping force of at least 100N per profile. In one embodiment of the invention, the at least one protrusion clamps the plate with a clamping force of at least 130N per profile at room temperature, more specifically at a temperature (more precisely, about 21 ℃) when the fixation element is used, for example during treatment. The inventors have found that under this clamping force, the fixing element is not damaged, for example by tearing of the plate, by falling of the plate out of the recess, or by accidental plastic deformation of the plate. The inventors have further found that in most common use cases, this clamping force at the deformation temperature is sufficient to resist the clamping force generated by the plate made of plastic material during the initial deformation, thereby forming the shape of the body part to be immobilized. The inventors have also found that in most common use cases this clamping force at room temperature is sufficient to resist the clamping force generated by the fixation element during actual use, e.g. during treatment of a patient.

In one embodiment of the invention, the sheet made of thermoplastic material comprises a single sheet. In an alternative embodiment of the invention, the plate made of thermoplastic material comprises several plates glued together to form a unitary structure. In one embodiment of the invention, the plate made of thermoplastic material has homogeneous material properties throughout the plate, such as a uniform modulus of elasticity, a uniform melting temperature and a uniform toughness. In an alternative embodiment of the invention, the plates made of thermoplastic material have non-uniform material properties, such as a non-uniform distribution of the thickness of the plates or a non-uniform distribution of the area of the plates. For example, a plate made of thermoplastic material may be composed of a plurality of plates having different material properties, or may be hardened in different amounts, for example by exposing different parts of the plate to UV under different process parameters.

In one embodiment of the invention, the plate made of thermoplastic material is perforated, for example to allow evaporation through the skin, and/or to allow visual inspection of the skin underneath the plate, and/or to minimize the damping effect of the plate. Preferably, the portion of the sheet made of thermoplastic material within the groove of the profile is not perforated to reduce the risk of deformation or tearing of the sheet within the groove. Preferably, the method is provided for perforating a sheet made of thermoplastic material. Preferably the method is arranged for perforating the sheet to clamp the sheet in the recess of the profiled surface.

In one embodiment of the invention, the plate made of thermoplastic material is permanently anchored in the groove of the profile, more particularly, to make it difficult to release. An advantage of this embodiment is that once the fixing element is assembled, the plate can no longer easily fall out of the mould surface. This may reduce the risk of accidental removal of the plate from the profile by the user of the fixation element, which may be troublesome, for example if the same patient has to use the same fixation element again in subsequent treatments.

In one embodiment of the invention the profile comprises first fixing means at a first side for fixing the profile to the panel and second fixing means at a second side different from the first side for releasably fixing the profile to the supporting surface. In one embodiment of the invention the first and second fixing means are arranged at opposite ends of the mould surface. In one embodiment of the invention the second fixing means are adapted to the type of support surface to which the mould surface is releasably connected. Examples of different types of second fixing means can be found in patent publications WO 9832402 and WO 2016050275.

In one embodiment of the invention, the mould surface is made of a plastic material selected from the group of: POM (polyoxymethylene), ABS (acrylonitrile butadiene styrene), PVC (polyvinyl chloride), polystyrene, polyamide, polypropylene, polycarbonate, (thermoplastic) polyurethane or equivalent materials. Preferably, the material of the profile has a higher impact hardness than the plate, e.g. a higher mohs hardness. Preferably, the profile has an indentation hardness higher than the plate, for example a higher vickers or rockwell hardness. Providing a profile made of these materials has the following advantages: the protrusions provided in the profiles are easier to attach, the profiles maintain their stiffness during heating of the panel and the risk of the panel damaging the protrusions under tension is reduced. Providing a profile made of said material and thus providing profile walls constituting the contact surfaces has the following advantages: during the formation of the projections, for example during deep-drawing of the projections, the projection walls become thinner and more flexible, so that a rivet connection can be formed. Providing a wall made of a harder material results in the protruding projecting wall being relatively hard, which makes it difficult to form the rivet. Providing a wall made of a softer material results in the protruding stub being relatively soft, which makes it difficult to form the rivet.

The invention further provides the use of the fixing element. More specifically, the present invention provides for the first use of a fixation element, wherein,

the fixing element is heated;

the plate made of thermoplastic material is pulled onto the body part to be immobilized, and

after the plate made of thermoplastic material has cooled down, it retains the shape of the body part to be immobilized. During the first use of the fixing element according to the invention, a tensile force is generated between the plate and the profile, which tensile force can be optimally absorbed by the fixing element according to the invention.

In one embodiment of the invention, the use of the immobilization element further comprises the immobilization element being used for immobilizing the patient's body part on the support surface after the plate made of thermoplastic material has cooled. During use of the fixing element according to the invention, a tensile force is generated between the plate and the mould surface, for example by the movement of the patient, which tensile force can be optimally absorbed by the fixing element according to the invention. In one embodiment of the invention, the use of the fixation element further comprises the use of the fixation element for medical diagnosis and/or radiotherapy, such as photon therapy, proton therapy, 3D conformal radiotherapy, IMRT (intensity modulated radiotherapy), IGRT (image guided radiotherapy) or stereotactic radiotherapy. In these embodiments, the body part of the patient must be fixed particularly accurately on the support surface, and this fixing usually requires repeated positioning of the body part to be fixed throughout the treatment, with little change in the fixing position. For example, it is well known that even a few millimeters of deviation in the positioning of a body part between simulated treatment and actual treatment or between repeated actual treatments can have an effect on the treatment success of proton radiation therapy. Thus, a deviation of, for example, a few millimetres may result in irradiation of not the tumour but the surrounding healthy tissue, which is unacceptable. In one embodiment of the invention, the fixation element is used as a fixation mask for fixing the head of a patient on a support surface, for example for irradiating or imaging cranial indications such as brain tumors.

Furthermore, the invention provides a machine for performing the method of the invention. In one embodiment of the invention, the machine comprises:

-a clamping device for receiving the profile and the plate;

a die provided with teeth for pressing at least one projection under pressure into the moulding surface; and

-a pressing device for pressing the mould surface and the mould to elastically deform the mould surface to form a first contact surface and a second contact surface provided with at least one protrusion.

The machine provided for carrying out the method of the invention has the following advantages: repeatable results are obtained because each profile is compressed in the same manner using the same die.

In one embodiment of the invention, the mould is provided with movable teeth which can be pressed out of the mould and into the mould surface under the influence of the pressing means until the desired height of the protrusion produced is h 1. In an alternative embodiment of the invention, the mould is provided with fixed die teeth which are pressed against the mould surface by the pressing means.

In one embodiment of the invention clamping means are provided for clamping the mould surface provided with the sheet in a groove of the mould surface. The clamping means are arranged for clamping the mould surface during pressing of the mould surface and the mould by the pressing means such that the mould surface does not move during pressing. Furthermore, the clamping device is arranged for clamping the mould surface during retraction of the teeth of the mould after compression of the mould surface and the mould, so that the mould surface is not displaced by the retraction of the teeth of the mould.

In one embodiment of the invention, the mould provided in the machine is replaceable. The replaceability of the mold offers the advantages of: the machine can be easily matched to another mould, for example in the event of wear of the mould. It is also possible, for example, that if a particular type of profile and plate requires protrusions of different shapes or arrangements, it is easy to install another die with other die teeth in the machine.

Drawings

In the following, the invention will be explained in more detail with reference to the following description and the attached drawings.

Fig. 1 shows a perspective view of a part of a fixing element.

Fig. 2 shows a fixing element for fixing a body part of a patient to a support surface.

Figure 3 shows the steps of the method of application of the profiles and plates.

Fig. 4 shows the step of placing a plate made of thermoplastic material in a recess of a first fixture of the mould surface.

Figure 5 shows the step of providing a machine for forming protrusions in the mould surface.

Figure 6 shows the use of the machine during the formation of the protrusion in the mould surface.

Fig. 7 shows the fixing element after removal of the machine for forming the protrusions.

Detailed Description

The present invention will be described with respect to well-defined embodiments and specific figures, but the invention is not limited thereto but only by the claims. The drawings described herein are for illustration purposes only and are not intended to be limiting. In the figures, the dimensions of some of the elements may be exaggerated, meaning that the elements discussed are not shown to scale, but are for illustrative purposes only. The dimensions and relative dimensions do not necessarily correspond to actual embodiments of the invention.

Furthermore, terms such as "first," "second," "third," or the like in the description and in the claims are used for distinguishing between similar elements and not necessarily for describing a sequential or chronological order. The terms so used are interchangeable under appropriate circumstances and the embodiments of the invention can occur in other sequences than described or illustrated herein.

The term "comprising" and derivatives as used in the claims should not be construed as limited to the means specified therein; the term does not exclude other elements or steps. The terms should be interpreted as specifying the indicated property, number, step or characteristic of the referenced component, but does not preclude the presence or addition of one or more secondary properties, numbers, steps or components, or groups thereof. Expressions such as "a device comprising means a and B" are not limited in scope to only devices consisting of only components a and B. Rather, in the context of the present invention, it means that the only relevant components are A and B.

Fig. 1 shows a perspective view of a part of a fixing element 1. The fixing element 1 comprises a plate 8 made of thermoplastic material and a mould surface 3. As shown in fig. 2, the fixing element 1 is used for fixing a body part of a patient (for example, the head of a patient) to a support surface 2. The plate 8 is intended to receive a body part to be immobilized. This is achieved as follows: the plate 8 may first be heated, for example in a warm water bath or oven or, for example, by electromagnetic radiation, so that the plate 8 is deformable and can be pulled onto the body part to be immobilized. After the plate 8 has cooled, for example after the plate has hardened further, the plate 8 is hardened and rigid, so that the body part can be fixed during the actual treatment. For this purpose, during the actual treatment, the body part to be immobilized is placed on the support surface 2 and the immobilization element 1 is connected to the support surface 2 via the profile 3, while the initially deformed plate 8 is placed on the body part to be immobilized. As shown in fig. 1, to this end the profile 3 comprises on a first side first fixing means 4 for fixing the profile 3 to a plate 8, and the profile 3 further comprises on a second side opposite to the first side second fixing means 5 for releasably fixing the profile 3 to the support surface 2. Since the second fixation means 5 releasably attach the profile 3 to the support surface 2, the fixation element 1 can be used for repeated actual treatments of a patient, preferably the same patient. As shown in fig. 1 and 2, the fixation element 1 is generally used for medical diagnosis and/or radiotherapy, in which fixation (e.g., repeated fixation) of a body part of a patient during diagnosis or treatment is crucial. Despite the high tension forces generated between the plate 8 and the profile 3 during the initial deformation of the plate 8 and during the actual use of the fixation element 1 in therapy, the plate 8 can be firmly and permanently fixed to the profile 3, for example during repeated treatments, by anchoring the plate 8 to the profile 3 with at least one protrusion 10 penetrating into the plate 8. As shown in fig. 1, the fixing element 1 is provided with a set of protrusions 10 which penetrate into the plate 8 to attach the plate 8 to the mould surface 3.

The method for manufacturing the fixation element 1 is further discussed below with reference to fig. 3 to 7. The method for manufacturing the fixation element 1 provides a plurality of successive steps, which may be carried out by the end user of the fixation element 1, for example by a caregiver prior to the initial deformation of the plate 8, or by the supplier of the fixation element 1 prior to delivery of the fixation element 1 to the end user.

As shown in fig. 3, the method for manufacturing the fixing element 1 comprises as a first step providing the mould surface 3. The profile provided comprises, on a first side, first fixing means 4 for fixing the profile 3 to a plate 8 and, on a second side opposite the first side, second fixing means 5 for releasably fixing the profile 3 to the support surface 2. The user of the fixing element 1 provides a profile 3 provided with second fixing means 5 of the correct type corresponding to the support surface 2 of the user and fixes it to the support surface 2 as required. The first fixing means 4 of the profile 3 comprise a groove 9 delimited by two opposite groove walls 15, wherein the two opposite groove walls are connected to each other in one piece. The groove 9 has an elongate direction parallel to the support surface 2, which direction is referred to as the longitudinal direction of the groove 9, a shorter transverse direction substantially perpendicular to the opposing groove walls 15, and a depth direction perpendicular to the longitudinal and transverse directions of the groove 9. The entire profile 3 is integrally formed, in other words the first fixing means 4 are integrally connected with the second fixing means 5. Fig. 3 also shows the step of providing a plate 8 made of thermoplastic material. The user of the fixation element 1 provides the plate 8 with the correct properties, e.g. the plate has the appropriate plate size and thickness, the appropriate material and the appropriate shape corresponding to the intended use of the fixation element 1. Thus, for example, when securing the same body part, the user provides a fat person with a larger and thicker plate 8 than a non-fat person, because providing a fat person with a plate 8 that is too small and too thin can result in overstretching the plate 8 upon initial deformation of the plate, which increases the risk of failure of the fixation element 1. Thus, for example, the user also provides a plate 8 shaped to fit the body part to be immobilized, for example as shown in fig. 2, the plate having a shape suitable for immobilizing the head of a patient. The plate 8 made of thermoplastic material as shown in fig. 3 is perforated, for example to allow evaporation through the skin, or to allow visual inspection of the skin underneath the plate, or to minimize the attenuation of the plate 8. The portion of the sheet 8 made of thermoplastic material that is to be placed in the recess 9 of the profiled surface 3 is not perforated in order to reduce the risk of the sheet 8 deforming or tearing in the recess 9 during use of the fixing element 1.

Fig. 4 shows the step of placing the plate 8 made of thermoplastic material in the recess 9 of the first fixation device 4. Fig. 4 shows the profile 3 arranged on a cross section perpendicular to the longitudinal direction of the groove 9. The recess 9 of the first fastening device 4 receives a plate 8 made of thermoplastic material therein. The opposing groove walls 15 describe the first contact surface 6 and the second contact surface 7, respectively, opposite the first contact surface 6, as the portions of the groove walls 15 lying along the plate 8. The plate 8 has a plate thickness dl approximately equal to the width of the groove 9.

In order to firmly and durably anchor the plate 8 in the groove 9 of the profile 3, a set of protrusions must be formed in the contact surfaces 6 and 7 of the profile 3, such that the protrusions penetrate into the plate 8. Fig. 5 to 7 show exemplary embodiments of forming the protrusions. As shown in fig. 5, a machine is provided for the above purpose. The machine comprises gripping means 13, for example grippers, for receiving the profile 3 and the plate 8. The machine furthermore comprises two dies 11 provided with teeth 12 for pressing at least one protrusion under pressure into the contact surface of the mould surface 3. In fig. 5, two molds 11 are placed next to the groove wall 15. Alternatively, there may be only one mould placed next to one of the groove walls, so that a protrusion is provided in only one of the groove walls 15. Furthermore, fig. 5 shows only one die 11 with a tooth 12, wherein fig. 5 shows a transverse cross section of the machine and the tooth 12 of the machine shown is aligned in the longitudinal direction on one opposing die 11 opposite to the die 11. Furthermore, the machine comprises a pressing device 14 for pressing the mould surface 3 and the teeth 12 of the mould 11 to plastically deform the mould surface 3 until at least one protrusion is provided in the first contact surface 6 and the second contact surface 7. In order to press the die teeth 12 and the mould surface 3 together, the die teeth 12 are first movably arranged in the mould 11, wherein the pressing means 14 push the die teeth 12 out of the mould 11; or secondly, the die teeth 12 are integrally connected with the die 11, wherein the entire die 11 provided with the die teeth 12 is pressed against the mould surface 3 by the pressing means 14. Fig. 5 shows a mold 11 with movable teeth 12. The transverse cross-section shown in fig. 5 describes only one tooth 12 in the depth direction of the groove 9. Preferably, the machine comprises a set of die teeth 12 corresponding to the pattern of projections to be applied, for example by providing a plurality of die teeth 12 in the depth direction of the groove 9. The gripping device 13 is further provided with an adjusting device 18, which adjusting device 18 is arranged for moving the moulds 11 towards or away from each other. This ensures in particular that the mould surfaces 3 are firmly clamped during the formation of the projection and during the removal of the teeth 12 from the projection if the moulds 11 are directed towards each other.

Figure 6 shows the use of the machine during the formation of the protrusions 10 in the mould surface 3. More specifically, fig. 6 shows the teeth 12 of the die 11 which plastically deform the contact surface 6 of the mould surface 3 to form the protrusions 10. The teeth 12 of the die 11 penetrate maximally into the plate 8. In this case, the plate 8 is not penetrated, but only partially. In one embodiment (not shown in fig. 6), the protrusion 10 is formed to protrude from the contact surface 6 provided with the protrusion by a maximum height h1, and the height h1 is smaller than the width of the groove, which is for example equal to the thickness dl of the plate 8, so that the protrusion cannot drill through the plate, for example cannot penetrate completely through the plate. Thus, a portion of the plate 8 is clamped between the projection 10 and the contact surface 7 opposite the contact surface 6 provided with the projection 10. The clamped plate 8 is formed with a fleece-like shape which ensures a firm adhesion of the plate 8 to the protrusions 10 and the contact surface 7 opposite the contact surface 6 provided with the protrusions 10. It is also possible that: when the die teeth 12 penetrate the mould surface 3 to the greatest extent, the height h1 is greater than the width of the groove, which is for example equal to the thickness d1 of the plate 8, provided that the plate 8 is only partially penetrated to form a fleece. This situation is illustrated in fig. 6. Fig. 6 further shows that the contact surface 7 opposite to the contact surface 6 provided with at least one protrusion 10 is provided with at least one protrusion 19, the protrusion 19 being opposite to the at least one protrusion 10, wherein the protrusion 19 faces outwards away from the plate 8. More specifically, the protrusions 19 are oriented in the same direction as the opposite protrusions 10. The clamped plate 8 is formed with a fleece-like shape which ensures that the plate 8 is firmly adhered to the protrusions 10 and the projections 19.

Fig. 7 shows the fixing element 1 after removal of the machine for forming the projections 10. After the teeth 12 of the machine are removed from the profile 3 and the plate 8, the hollow projections 10 remain. In the example described herein, the material properties and dimensions of the groove walls 15 and the plate 8 made of thermoplastic material are chosen such that the formed projections 10 can form a rivet joint. If the projection 10 is formed by deep-drawing a small area of the contact surface 6, the projection is formed such that the projection wall 16 is thin and the projection head 17 is relatively thick. The resulting protrusion 10 thus has a relatively hard and rigid protrusion head 17 compared to the relatively soft protrusion wall 16. As shown in fig. 6, the plate 8, which is made of thermoplastic material, is elastically stretched after penetration of the teeth 12, and the plate 8 tends to elastically spring back after removal of the teeth 12. Since the projecting wall 16 is relatively flexible compared to the projecting head 17, the plate 8 will spring back elastically under the compression of the projecting wall 16, while the projecting head 17 remains almost unchanged. At this point, at least a portion of the plate 8 is clamped between the projecting head 17 and the contact surface 6 provided with the projections 10, namely: forming a rivet joint. The riveting thus formed ensures optimum anchoring of the plate 8 in the groove 9 of the profile 3. The anchoring provides a strong and durable plate connection without the use of external materials to form the rivets. Furthermore, the rivet thus formed is hardly affected by atmospheric effects, since it is not necessary to use secondary glue, such as glue or the like.