Silicone mold for making in line a prosthesis to be applied

Abstract

Described is a mold (100) for prosthesis comprising a first shell (1) and a second shell (2), movable between a closed configuration and an open configuration, wherein the respective edges (1a, 1b) are at least partly spaced from each other. The second shell (2) comprises a deformable portion (4), movable relative to the first shell (1), between a casting position, in which the inner volume has a first value, and a compression position, in which the inner volume has a second value, less than the first value. Further is described a mold (100) for prosthesis being movable between a mold position (PST) and an insertion position (PIN) wherein in the insertion position (PIN): (a) a first access portion (PA1) and a second access portion (PA2) are spaced from each other to define an insertion opening (AIN) where the mold fluid is inserted, and (b) the base edge (2b,) of the second shell remains at least partly in contact with the edge (1 b) of the first shell. Further is described a cranial prosthesis (300) provided with a plurality of flanges along the edge (301b) of its main body (301).

Description

[0001] DESCRIPTION SILICONE MOLD FOR MAKING IN LINE A PROSTHESIS TO BE APPLIED

[0002] Technical field

[0003] This invention relates to a mold for making a prosthesis starting from a mold fluid, such as, for example, a liquid resin.

[0004] Background art

[0005] In other words, this invention applies to the medical sector, in particular to the sector of systems for making implantable prosthetic devices.

[0006] In more detail, the invention addresses the sector of systems for making patient-specific cranial prostheses.

[0007] In detail, following a decompressive craniectomy operation, that is to say, following a removal of a part of the cranial cap, a cranial plastic surgery operation is necessary to replace the removed part of the cranial cap by means of a special prosthetic device.

[0008] It is known to perform a cranial plastic surgery operation by implanting a patient-specific cranial prosthesis, in such a way as to replace the portion of cranial cap removed, at the same time obtaining a homogeneity between the implanted prosthesis and the physiognomy of the remaining cranial cap.

[0009] In this context, a common technique for producing a cranial prosthesis consists of 3D printing, based on CT images of the patient, a suitable mold that can be used intra-operatively to make the prosthesis. In other words, the prior art teaches the production of the mold in a pre-operative stage and the use of the mold to make the prosthesis in an intra-operative stage. Use is known of a mold fluid, such as, for example, a liquid resin, to be cast and left to cure in a gap formed by the mold, in such a way as to obtain a patient-specific prosthesis having a geometry suitable for obtaining a uniformity between the prosthesis and the anatomy of the remaining cranial cap. However, a prosthesis produced starting from a prior art mold has a useful life which is often less than the life expectancy of the patient, causing the patient to have a high probability of having to undergo invasive cranial plastic surgery several times.

[0010] In effect, it is known that air bubbles are formed in the mold during a casting of the mold fluid which, after curing, remain trapped in the body of the prosthesis produced.

[0011] The presence of air bubbles in a prosthesis causes zones of weakness in the body of the prosthesis (at the bubbles), with a consequent decrease in the useful life of the latter.

[0012] In addition, the molds of known type are difficult to re-use if it is necessary to repeat the cranial plastic surgery, determining not only greater waiting times but also higher costs.

[0013] Aim of the invention

[0014] For this reason, the technical purpose which forms the basis of this invention is to propose a mold for prosthesis that overcomes the drawbacks of the prior art.

[0015] In particular, the aim of this invention is to provide a mold for prosthesis which is reusable.

[0016] An aim of this invention is also to provide a mold for prosthesis useful for making a durable prosthesis. In other words, an aim of the invention is to provide a mold for prosthesis having a useful life equal to or greater than a patient's life expectancy.

[0017] Another aim of the invention is to provide a mold for prosthesis which allows an prosthesis to be obtained without or with a reduced number of zones of weakness in such a way as to be structurally resistant.

[0018] The technical purpose indicated and the aims specified are substantially achieved by a mold for prosthesis comprising the technical features described in one or more of the accompanying claims.

[0019] The dependent claims correspond to possible embodiments of the invention.

[0020] In particular, this invention provides a mold for prosthesis comprising a first shell, having a respective wall and a respective edge, and a second shell, having a respective wall and a respective edge.

[0021] The mold is movable between a closed configuration, to allow casting and subsequent curing of the mold fluid in such a way as to produce a prosthesis, and an open configuration, for extracting the prosthesis produced.

[0022] Preferably, the mold (that is, at least one between the first shell or the second shell) has the shape of a spherical or semi-spherical cap.

[0023] Preferably, the prosthesis produced is a cranial prosthesis, however this invention can also be used for prostheses of another type.

[0024] In the closed configuration, the first and the second shells are connected to each other at the respective edges to define an inner volume, configured for containing a mold fluid.

[0025] More in detail, the mold comprises a mold opening to allow, in the closed configuration of the mold, casting of the mold fluid in the inner volume.

[0026] In the open configuration, the edges, respectively, of the first and second shell are at least partly spaced from each other.

[0027] Advantageously, the open configuration provides a mold which can facilitate extraction of an prosthesis from the mold and which avoids the need for incision or failure of the first shell or the second shell.

[0028] The mold also comprises a deformable portion, movable to define a variation of the inner volume of the mold when in the closed configuration. Advantageously, the variation of the inner volume of the mold is required both for its filling with a mold fluid and for evacuating any air bubbles contained in the mold fluid cast inside the inner volume.

[0029] According to an aspect of this invention, the deformable portion is movable between a casting position, wherein the inner volume has a first value, and a compression position, wherein the inner volume has a second value, less than the first value. For this reason, the deformable portion is in direct contact with the mold fluid and is movable to define a movement of the mold fluid inside the inner volume of the mold.

[0030] Advantageously, the casting position allows a mold fluid to be cast preventing any escape of the latter from the mold.

[0031] Advantageously, moreover, the compression position allows the cast mold fluid, and thus contained, to be compressed in the inner volume the mold, favouring an escape of any air bubbles.

[0032] Thus, the mold allows the production of a prosthesis which is durable and without areas of weakness.

[0033] According to an embodiment, the mold comprises a mold opening passing through the wall of the first shell, whilst the deformable portion is positioned at the second shell and is movable relative to the first shell.

[0034] More preferably, the mold opening and the deformable portion face each other.

[0035] Advantageously, this embodiment determines an optimisation of the compression of the mold fluid cast and therefore contained in the inner volume, favouring in a significant manner an escape of any air bubbles. For this reason, this embodiment of the mold is able to produce a prosthesis which is durable as well as free of areas of weakness.

[0036] According to further embodiments of this invention, the mold opening and the deformable portion are both positioned at the first shell or at the second shell, or one between the mold opening and the deformable portion is positioned on the first shell, whilst the other is positioned on the second shell.

[0037] According to one aspect of the invention, the mold comprises a gripping element.

[0038] The gripping element is configured for determining a movement of the deformable portion between the casting position and the compression position. In other words, a movement of the gripping element corresponds to a movement of the deformable portion. According to an aspect of the invention, the gripping element is associated with the deformable portion.

[0039] The gripping element is positioned outside the inner volume in the closed configuration, in such a way as to be grippable by an operator.

[0040] In other words, the gripping element can be grasped for moving the deformable portion between the casting position and the compression position.

[0041] Preferably, the deformable portion is positioned at the second shell and the gripping element is associated with the second shell.

[0042] The gripping element which can be grasped allows an operator to grip the mold securely and independently, for example for casting a mold fluid into its inner volume.

[0043] The gripping element which can be grasped allows an operator to move the deformable portion between the casting position and the compression position in a facilitated, autonomous and manually modular manner.

[0044] Advantageously, therefore, the gripping element contributes to an intraoperative production speed of a prosthesis starting from the mold, thus guaranteeing a shorter surgical time. In addition, the gripping element which can be gripped allows an operator to handle and fill the mold even without the need for help by an assistant.

[0045] According to an aspect of this invention, the mold comprises a bottom wall facing the deformable portion and defining with the deformable portion an inner cavity of the mold.

[0046] The inner chamber can be depressurised and pressurised for moving the deformable portion, respectively, between the casting position and the compression position.

[0047] For this reason, according to an aspect of this invention, the mold comprises an inner cavity at least partly facing the deformable portion, wherein the inner cavity can be pressurised and depressurised. A pressurization of the inner cavity corresponds to the compression position of the deformable portion, and a depressurization of the inner cavity corresponds to the casting position of the deformable portion.

[0048] A pressurization and a depressurization of the inner cavity causes a modulation of the movement between the casting position and the compression position of the deformable portion.

[0049] According to one aspect of this invention, the inner cavity can be connected to a pumping element for receiving pressurised air.

[0050] Preferably, the pumping element can be controlled by an operator, advantageously allowing a facilitated and immediate modulation of the movement between the casting position and the compression position of the deformable portion.

[0051] According to an aspect of this invention, the bottom wall has a first hardness value, and the deformable portion has a second hardness value, less than the first hardness value.

[0052] In other words, the deformable portion has a capacity of deforming greater than that of the bottom wall.

[0053] Advantageously, the bottom wall having a hardness greater than the hardness of the deformable portion guarantees that a pressurisation or depressurisation of the inner cavity corresponds to a significant deformation of only the deformable portion (in direct contact with the mold fluid) and, if necessary, to a minimum deformation of the bottom wall, optimising an evacuation of air bubbles contained in the inner volume of the mold.

[0054] According to an aspect of the invention, the first shell and the second shell have a thickness of between 0.4 mm and 6 mm.

[0055] According to an aspect of this invention, the distance between the inner surface of the first shell and the inner surface of the second shell is between 0.4 mm and 6 mm, thus defining a corresponding thickness of the cranial prosthesis which is determined from said distance.

[0056] This thickness is customisable on the basis of the requests of an operator, for example a surgeon.

[0057] According to an aspect of the invention, the edge of one between the first and the second shell comprises a lip, defining a housing cavity, configured to receive the edge of the other shell, in such a way as to define a closed end of the mold in the closed configuration.

[0058] Preferably, both the first and the second shell comprise a respective lip, wherein the lip of one between the first and the second shell defines a housing cavity configured to receive the lip of the other shell.

[0059] Advantageously, the lip prevents leaks of mold fluid from the mold, consequently resulting in savings in terms of material used as well as facilitating production of the prosthesis, which is also achieved intra- operatively.

[0060] Preferably, the edge of the second shell comprises the lip, which defines a housing cavity configured to receive the edge of the first shell.

[0061] According to an aspect of the invention, the lip has a respective hardness value and the remaining part of the shell comprising the lip has a respective hardness value less than the hardness value of the lip.

[0062] Advantageously, a lip having a hardness value greater than the hardness value of the shell in which it is comprised determines a closed end which has a greater hardness than the rest of the mold, optimising a saving in terms of material used.

[0063] According to an aspect of the invention, one between the first shell and the second shell comprises a protuberance proximal to the respective edge and facing towards the inner volume in the closed configuration.

[0064] The protuberance allows a prosthesis to be obtained starting from the mold, having, at a relative end edge, flanges which are useful for positioning and directing the prosthesis.

[0065] Advantageously, therefore, the mold comprising the protuberance is able to produce a prosthesis such as to facilitate an operator in the performance of cranial plastic surgery.

[0066] According to an aspect of the invention, the first shell and the second shell comprise respective reference profiles facing each other in the closed configuration. Advantageously, the reference profiles allow the first and the second shells to be correctly positioned to obtain the closed configuration of the mold, consequently facilitating an operator and preventing an incorrect use of the mold.

[0067] According to an aspect of the invention, the first shell and the second shell are made of a transparent material.

[0068] Advantageously, the transparent material allows an operator to inspect the mold fluid contained in the inner volume of the mold, in such a way as to identify any air bubbles and check their ejection by moving the deformable portion between the casting position and the compression position.

[0069] According to an aspect of the invention, the first shell and the second shell are made of high consistency silicone rubber.

[0070] Advantageously, this material allows a re-use and subsequent sterilisation of the mold, for example if it is necessary to repeat a cranial plastic surgery on a same patient, or if it is necessary to reject a prosthesis produced and produce a new one.

[0071] Moreover, advantageously, the high consistency silicone rubber, as it is deformable by manual pressure (which can be applied, for example, with the fingers) allows a variation in the inner volume to be determined in predetermined zones, facilitating an expulsion of air bubbles from a mold fluid positioned inside the inner volume. The above-mentioned material is particularly functional for expelling air bubbles if the latter are located in a peripheral portion, that is to say, proximal to the closed end, of the inner volume of the mold.

[0072] Preferably, the first shell and the second shell are made of dimethyl-vinyl- siloxane with reinforcing silica.

[0073] According to an aspect of this invention, the mold comprises a support portion, which can be rested on a work surface and configured to define a stable support of the mold on the work surface.

[0074] Preferably, the second shell comprises the support portion and the deformable portion. This invention also provides a kit comprising the mold having the inner cavity, and a pumping element, connectable to the inner cavity of the mold.

[0075] The pumping element is configured to define a depressurisation and a pressurisation of the inner cavity of the mold, in such a way as to move the deformable portion between the casting and compression positions.

[0076] According to an aspect of the invention, the pumping element comprises a respective chamber which can be manually depressurised and pressurised, to define, respectively, a depressurisation and a pressurisation of the inner cavity.

[0077] Advantageously, the cavity which can be manually depressurised and pressurised allows a manual and intuitive modulation of the depressurization and pressurization of the cavity inside the mold, facilitating an operator in production of the prosthesis and in the evacuation of air bubbles from the mold fluid cast inside the mold.

[0078] According to an aspect of the invention, the pumping element comprises a pair of membranes delimiting the chamber of the pumping element, configured to maintain a depressurisation and / or a pressurisation of the chamber.

[0079] Advantageously, the membranes are able to facilitate an operator in the production of the prosthesis and in the evacuation of air bubbles from the mold fluid cast inside the mold.

[0080] This invention provides a cranial prosthesis made by casting on the mold. By casting a mold fluid on the mold it is also possible to make prostheses of another type.

[0081] The cranial prosthesis comprises a concave main body comprising a respective wall and a respective edge.

[0082] The cranial prosthesis comprises a plurality of flanges arranged along the edge of the main body.

[0083] Advantageously, the flanges allow a facilitated positioning of the prosthesis during an operating step. The prosthesis is preferably made of polymethyl methacrylate (PMMA).

[0084] The invention also allows the drawbacks of the prior art to be overcome by providing a method for making the prosthesis.

[0085] The method comprises preparing a mold comprising a first shell, having a respective wall and a respective edge, and a second shell, having a respective wall and a respective edge.

[0086] Preferably, the method comprises providing a mold according to one or more of the embodiments described in this invention.

[0087] The method comprises a step of closing the mold, in such a way as to define an inner volume of the mold.

[0088] The closing step is performed by constraining the first shell and the second shell along the respective edges, in such a way as to define an inner volume configured to contain a mold fluid.

[0089] The method comprises a step of casting a mold fluid inside the inner volume through a mold opening passing through one between the first and the second shell, preferably the first shell.

[0090] The method comprises a step of curing the mold fluid cast inside the inner volume, to obtain a prosthesis.

[0091] The method comprises a step of opening the mold for extracting the prosthesis obtained.

[0092] The opening step is performed by at least partly spacing the edge of the first shell and the edge of the second shell, in such a way as to extract the prosthesis obtained without damaging the mold or the prosthesis.

[0093] According to an aspect of this invention, the casting step comprises a step of moving a deformable portion of the mold to determine a variation in the inner volume of the mold.

[0094] Preferably, the casting step comprises a step of moving a deformable portion of the second shell relative to the first shell between a casting position, wherein the inner volume of the mold has a first value, and a compression position, wherein the inner volume of the mold has a second value, less than the first value. Advantageously, the movement step allows the cast mold fluid contained in the inner volume to be compressed, favouring in a significant manner an escape of any air bubbles. Therefore, advantageously, the method made available by this invention is designed to produce a prosthesis which is durable as well as free from areas of weakness.

[0095] According to an aspect of the invention, the closing step is performed by placing a reference profile of the first shell facing a corresponding reference profile of the second shell. Advantageously, the method avoids any errors in the application of this method.

[0096] Further features and advantages of this invention are more apparent in the non-limiting description below, with reference to preferred, non-limiting embodiments of a mold for prosthesis and a method for making the prosthesis. A further embodiment of the mold according to this invention is described below. Some of the features described can be combined with the embodiments described above since they are not indissolubly linked to all the aspects of the embodiment described below.

[0097] The mold for prosthesis according to this embodiment comprises the first shell. The first shell comprises an outer surface, facing towards the outside of the mold.

[0098] The first shell comprises the respective edge. The respective edge comprises a first access portion (that is to say, a first access stretch). The first shell has a partly spherical cap shape with a zone which extends outside the spherical cap. Said zone defines the first access portion.

[0099] The mold for prosthesis according to this embodiment comprises the second shell. The second shell comprises a base edge. The second shell comprises a flap which rises from the base edge. The respective flap defines a peripheral edge. The respective base edge comprises a second access portion (that is to say, a second access stretch). The second shell has a partly spherical cap shape with a zone which extends outside the spherical cap. Said zone defines the second access portion. The respective second access portion is defined at the interruption of the flap. The mold for prosthesis according to this embodiment has a closed configuration. The respective closed configuration is made by attaching the first shell and the second shell. The closed configuration defines an inner volume. The respective inner volume is configured to contain a mold fluid.

[0100] The mold for prosthesis according to this embodiment has an open configuration. The respective open configuration is made by spacing at least partly the first shell and the second shell. The open configuration allows the prosthesis to be extracted from the mold. The mold for prosthesis according to this embodiment is movable between the closed configuration and the open configuration.

[0101] In the closed configuration, the mold for prosthesis according to this embodiment is movable between a mold position and an insertion position. In the respective mold position, the first access portion and the second access position are in contact with each other. In the mold position, the contact between the first access position and the second access position prevents access to the inner volume and prevents the mold fluid from escaping from the inner volume. In the mold position, the base edge of the second shell is in contact with the edge of the first shell.

[0102] In the respective insertion position, the first access portion and the second access portion are (at least partly) spaced from each other. In the insertion position, the distance between the first access position and the second access position defines an insertion opening where the mold fluid is inserted. In the insertion position, the base edge of the second shell remains at least partly in contact with the edge of the first shell.

[0103] The presence of the mold position, obtained by constraining the first access position and the second access position, and of the insertion position, obtained by spacing the first access position and the second access position, allows a larger insertion opening to be obtained in which to insert the mold fluid. The respective mold fluid has a very high viscosity which would be very complex to cast in a narrow insertion opening such as that described above. The mold fluid has a viscosity which is high enough to require the use of an instrument as an aid for being inserted in the insertion opening.

[0104] Advantageously, this embodiment allows the mold fluid to be introduced inside the insertion opening by means of an instrument (for example a spatula) allowing the use of mold fluids with very high viscosity. According to an embodiment, in the mold position, the first access portion and the second access portion are in contact with each other but not connected.

[0105] In the closed configuration, the mold for prosthesis according to this embodiment is movable between the mold position and the insertion position under the effect of a pressure applied along a direction at least partly perpendicular to a direction of insertion, perpendicular to the insertion opening.

[0106] Advantageously, the fact that, in the mold position, the first access portion and the second access portion are not connected allows the opening with a single hand due to the pressure applied. Opening the mold with a single hand facilitates the manoeuvrability of the mold.

[0107] According to an embodiment, the flap of the second shell comprises a first portion. The respective first portion has a first thickness. The first portion is connected to the base edge of the second shell.

[0108] According to this embodiment, the flap of the second shell comprises a second portion. The respective second portion has a second thickness. The second portion is connected to the first portion. The second portion culminates in the peripheral edge.

[0109] The respective second thickness is greater than the first thickness, in such a way as to form a housing groove. The respective housing groove faces towards the inner volume.

[0110] According to this embodiment, the first shell comprises a raised portion. The respective raised portion rises from the outer surface of the first shell. The raised portion extends, starting from the edge, towards the inside of the first shell. The raised portion is interrupted at the first access portion. The raised portion is configured to be inserted inside the housing groove in the closed configuration of the mold. Advantageously, this embodiment allows the mold to be closed in a more solid and effective manner.

[0111] Moreover, this embodiment gives a connection between the first shell and the second shell which is more stable.

[0112] In this embodiment, too, the mold for prosthesis comprises the gripping element. The relative gripping element is positioned on the outer surface of the second shell. The gripping element is proximal to the second access portion.

[0113] Advantageously, the gripping element facilitates the spacing between the first access portion and the second access portion.

[0114] Advantageously, the gripping element facilitates the opening of the mold with a single hand.

[0115] Brief description of the drawings

[0116] The description is set out below with reference to the accompanying drawings which are provided solely for purposes of illustration without restricting the scope of the invention and in which:

[0117] - Figure 1 is a schematic view of a mold for prosthesis in the open configuration;

[0118] - Figures 2 to 5 show respective schematic cross-sections of the mold of Figure 1 in a relative first embodiment during respective operating configurations;

[0119] - Figure 6 shows a schematic view of a kit for making a prosthesis comprising the mold of Figure 1 according to a relative second embodiment;

[0120] - Figure 7 shows a schematic view of the mold according to a further embodiment;

[0121] - Figure 8 shows a patient-specific cranial prosthesis obtained using the mold of Figures 1-7; - Figure 9 shows a schematic view of the first and second shells for mold for prosthesis according to another embodiment;

[0122] - Figures 10 shows a schematic cross section view of the mold of Figure 9 during the closed configuration;

[0123] - Figure 11 shows a schematic cross section view of the mold of Figure 9 during the open configuration;

[0124] - Figures 12 and 13 show respective schematic cross sections of the mold of Figure 9, during the respective operating positions. The respective operating positions, as shown in the drawings, are the insertion position and the mold position.

[0125] - Figure 14 shows a schematic view of the first and second shells for mold for prosthesis of Figure 9 in the mold position;

[0126] - Figure 15 shows a schematic view of the first and second shells for mold for prosthesis of Figure 9 in the insertion position.

[0127] Detailed description of preferred embodiments of the invention

[0128] In this description, the reference numeral 100 has been used to denote in its entirety a mold for prosthesis, hereinafter referred to for simplicity as “mold 100”.

[0129] With reference to Figure 1 , the mold 100 comprises a first shell 1 , having a respective wall 1 a and a respective edge 1 b delimiting the wall 1 a.

[0130] The mold 100 also comprises a second shell 2, having a respective wall 2a and a respective edge 2b delimiting the wall 2a.

[0131] According to an aspect of the invention, the mold 100 is made from a master, made of polyactic acid (PLA) by 3D FDM printing starting from TAC images of a patient. In other words, the mold 100 is patient-specific.

[0132] With reference to Figures 2 to 5, the mold 100 is movable between a closed configuration (illustrated in Figures 2 and 3), wherein the first shell 1 and the second shell 2 are connected to each other at the respective edges 1b, 2b to define an inner volume “V” configured to contain a mold fluid, and an open configuration (illustrated in Figures 4 and 5), wherein the edges 1 b, 2b of the first shell 1 and second shell 2 are at least partly spaced from each other.

[0133] According to an aspect of the invention, during a production step of the mold 100 starting from the respective master, the edges 1 b and 2b are reshaped in such a way as to determine a precise coupling between the first and the second shells 1 and 2 in the closed configuration, advantageously facilitating the closing of the mold. In this way it is possible to prevent an escape of mold fluid from the mold 100.

[0134] Preferably, in the open configuration, the first shell 1 is completely separated from the second shell 2.

[0135] Advantageously, the open configuration allows a prosthesis to be easily extracted from the mold 100 without incision or damage to the mold 100. In other words, the mold 100 is reusable. For example, the mold 100 is deformable to facilitate extraction of the prosthesis. In particular, an operator who intends to extract the prosthesis can grip two portions of the edge 2b of the second shell 2, moving them away from each other without the second shell 2 being damaged, allowing the easy extraction of the first shell 1 , that is, of the prosthesis from the second shell 2.

[0136] Preferably, the edge 2b of the second shell 2 comprises a lip 20, defining a housing cavity 21 , configured to receive the edge 1 b of the first shell 1 , in such a way as to define a closed end “E” of the mold 100 in the closed configuration.

[0137] Advantageously, the lip 20 prevents an escape of the mold fluid from the mold 100 when in the closed configuration.

[0138] More preferably, the lip 20 has a respective hardness value and the remaining part of the second shell 2 has a respective hardness value less than the hardness value of the lip 20, thus defining a reinforced closed end

[0139] A hardness of the lip 20 greater than a hardness of the rest of the second shell 2 advantageously guarantees a hermetic seal of the mold 100 at the closed end “E”. The mold 100 comprises a mold opening 3, passing through the wall of the first shell 1 to allow, in the closed configuration of the mold 100, a casting of the mold fluid in the inner volume ‘V’, as schematically illustrated in Figure 2.

[0140] The mold opening 3 preferably has a circular profile with a diameter of between 0.5 cm and 2 cm, preferably the circular profile of the mold opening is equal to 1 .55 cm.

[0141] Preferably, the mold 100 comprises, at the mold opening 3, a funnel- shaped portion (not illustrated in the accompanying drawings) which is able to facilitate a casting of mold fluid through the mold opening 3.

[0142] The second shell 2 comprises a deformable portion 4, movable (as schematically identified by the arrow “F” of Figure 3) relative to the first shell 1 and preferably facing the mold opening 3.

[0143] A movement of the deformable portion corresponds to a variation of the inner volume “V” identified by the mold 100 when in the closed configuration.

[0144] In detail, the deformable portion 4 is movable between a casting position, wherein the inner volume “V” has a first value, and a compression position, wherein the inner volume “V” has a second value, less than the first value.

[0145] In other words, the deformable portion is movable towards the mold opening 3 for determining (in the compression position) a reduction in the inner volume “V” identified by the mold 100 when in the closed configuration.

[0146] The deformable portion 4 is in contact with the inner volume “V”, and consequently with the mold fluid inside it, allowing both a mold fluid to be cast into the mold opening 3 in such a way as to prevent any escape by the latter from the mold 100 (thanks to the casting configuration), and to compress the mold fluid cast, and therefore contained, into the inner volume “V” in such a way as to favour escape of any air bubbles, which would cause zones of weakness of the prosthesis obtained using the mold 100. For this reason, the deformable portion 4 advantageously guarantees a saving in material and the obtaining of a resistant prosthesis (that is to say, with a minimum content of air bubbles, if not entirely absent).

[0147] Preferably, the deformable portion 4 is also movable in such a way as to allow a facilitated extraction of the first shell 1 , that is, of the prosthesis. In other words, an operator who intends to extract the prosthesis from the mold 100 can deform the deformable portion 4 so as to obtain a thrust effect on the first shell 1 , that is to say, on the prosthesis, which allows a safe extraction and which does not damage the mold 100, that is to say, the prosthesis.

[0148] Preferably, the first shell 1 and the second shell 2 have a thickness of between 0.4 mm and 6 mm, customisable according to instructions from an operator.

[0149] According to a first embodiment illustrated schematically in Figures 2 to 5, the mold 100 comprises a gripping element 5 positioned outside the inner volume “V” in the closed configuration.

[0150] Preferably, the gripping element 5 is made of the same material with which the mold 100 is made.

[0151] The gripping element 5 is associated with the second shell 2 and can be grasped for moving the deformable portion 4 between the casting position and the compression position.

[0152] Advantageously, the gripping element 5 allows an operator, for example a surgeon, to support the mold 100 with a single hand, therefore making the operator independent in the casting of mold fluid through the mold opening 3.

[0153] Advantageously, the gripping element 5 also guarantees a control of an escape of the residual air bubbles in the mold fluid cast, allowing the deformable portion 4 to be moved, even intermittently, between the casting position and the compression position.

[0154] The gripping element 5 can be made in the form of a knob, or a ring, or other devices suitable for being gripped manually by an operator. According to a second embodiment, illustrated schematically in Figure 6, the second shell 2 comprises a bottom wall 6 facing the deformable portion 4 and defining, with the deformable portion 4, an inner cavity 7.

[0155] In other words, the mold 100 according to the second embodiment, in the closed configuration comprises a first gap, defining the inner volume “V”, and a second gap, defining the inner cavity 7 and separated from the first gap by the deformable portion 4.

[0156] The inner cavity 7 can be depressurised and pressurised for moving the deformable portion 4, respectively, between the casting position and the compression position. In other words, a depressurisation of the inner cavity 7 corresponds to the casting configuration, whilst the pressurisation of the inner cavity 7 corresponds to a reduction of the inner volume “V” and therefore to the compression position.

[0157] Preferably, the pressurisation and depressurisation of the inner cavity 7 can be performed by means of a suitable pumping element 200 which can be connected to the inner cavity 7. In other words, the inner cavity 7 is connectable to the pumping element 200 for receiving pressurised air.

[0158] Advantageously, the inner cavity 7 guarantees a facilitated manual control of an escape of the residual air bubbles in the mold fluid cast, allowing movement, even intermittently, of the deformable portion between the casting position and the compression position. In fact, in order to move the deformable portion 4, an operator must only operate the pumping element 200 connected to the inner cavity 7 (facing the deformable portion 4).

[0159] Preferably, the bottom wall 6 has a first hardness value and the deformable portion 4 has a second hardness value, less than the first hardness value. In other words, the bottom wall 6 is less deformable than the deformable portion 4, advantageously guaranteeing that a pressurisation / depressurisation of the inner cavity 7 corresponds to a deformation of the deformable portion 4, and, if necessary, a minimum deformation of the bottom wall 6, optimising an escape of air bubbles from the inner volume “V”. In accordance with one aspect of this invention, the mold 100 comprises a support portion 10.

[0160] The support portion 10 can be rested on a work surface and is configured to define a stable support of the mold 100 on the work surface.

[0161] Advantageously, the support portion 10 allows the mold 100 to be placed in a firm manner, preventing it from oscillating.

[0162] More in detail, according to the second embodiment, the support portion 10 advantageously prevents oscillations of the mold 100 resting on a work surface during a movement (performed by the pumping element 200) of the deformable portion 4 between the compression and casting positions. According to an aspect of the invention and with reference to Figure 7, the second shell comprises a protuberance 8 proximal to the respective edge 2b and facing towards the inner volume “V” in the closed configuration.

[0163] Advantageously, the protuberance 8 allows a prosthesis to be obtained starting from the mold 100 comprising flanges useful for its positioning (the protuberance 8 is in effect configured to define a flange of the prosthesis having a thickness less than a thickness of the prosthesis).

[0164] According to an aspect of the invention, and with reference to Figure 1 , the first shell 1 and the second shell 2 comprise respective reference profiles 9 facing each other in the closed configuration.

[0165] Advantageously, the reference profiles 9 allow a correct coupling (to define the closed configuration) between the first shell 1 and the second shell 2, preventing any errors in use of the mold 100 for making a prosthesis.

[0166] According to an aspect of the invention, the first shell 1 and the second shell 2 are made of a sterilizable material. Preferably, the first shell 1 and the second shell 2 are made of a material which can be sterilized several times, thus increasing the number of uses of the mold 100.

[0167] According to an aspect of the invention, the first shell 1 and the second shell 2 are made of a transparent material.

[0168] Advantageously, the transparent material allows an operator to control a casting of the mold fluid and to locate any residual air bubbles in the mold fluid cast, as well as to guide them more easily towards the mold opening 3.

[0169] In other words, the transparent material facilitates an operator in obtaining a prosthesis of satisfactory quality.

[0170] More in detail, the first and the second shells 1 , 2 are made of high consistency silicone rubber.

[0171] The silicone rubber is deformable also by applying low pressures, so the first and the second shell 1 , 2 are deformable manually by an operator. Consequently, in conjunction with the deformable portion 4, the silicone rubber allows an operator to perform a facilitated evacuation of air bubbles from the mold fluid cast in the inner volume “V” of the mold 100.

[0172] Preferably, the first shell 1 and the second shell 2 are made of dimethyl- vinyl-siloxane with reinforcing silica.

[0173] The invention also provides a kit for making a prosthesis illustrated schematically in Figure 6.

[0174] The kit comprises a mold 100 having the bottom wall 6 facing the deformable portion 4 and defining, with the deformable portion 4, the inner cavity 7.

[0175] The kit also comprises the pumping element 200 illustrated schematically in Figure 6.

[0176] According to an aspect of the invention, the mold 100 and the pumping element 200 are movable between a separated configuration, wherein the mold 100 and the pumping element 200 are separate from each other, and an operating configuration, wherein the mold 100 and the pumping element 200 are in fluid communication with each other.

[0177] In detail, the pumping element 200 comprises a chamber 201 which can be manually pressurised and depressurised, which can be connected to the inner cavity 7 of the mold 100 for pressurising and depressurising it, in such a way as to move the deformable portion 4, respectively, between the compression position and the casting position. In more detail, the pumping element 200 comprises a connecting portion 200c, configured for placing in fluid communication the chamber 201 of the pumping element 200 with the inner cavity 7 of the mold 100.

[0178] In other words, in the operating configuration, the chamber 201 of the pumping element 200 is put in fluid communication with the inner cavity 7 of the mold 100.

[0179] According to an aspect of the invention, the kit comprises a tubular element 203, associated with the connecting portion 200c, and the mold 100 comprises a connecting hole “B”, facing the inner cavity 7 and configured for forming a connection with the tubular element 203, in such a way as to place in fluid communication the inner cavity 7 with the chamber 201.

[0180] According to an aspect of the invention, the pumping element 200 comprises a support portion 200a, which can be rested on a work surface in such a way as to define a firm and stable support of the pumping element 200 on the work surface, and an activation portion 200b which is manually deformable and opposite the support portion 200a.

[0181] The chamber 201 of the pumping element 200 is delimited by the support portion 200a and by the activation portion 200b.

[0182] For this reason, a manual compression and decompression of the activation portion 200b correspond to a pressurising and depressurising of the chamber 201 and, consequently, of the inner cavity 7 (in the operating configuration).

[0183] Advantageously, the activation portion 200b thus allows an operator to pressurise and depressurise the chamber 201 and, consequently, in the operating configuration, the inner cavity 7 of the mold 100 in a controlled manner, manually imposing a compression and a decompression of the activation portion 200b.

[0184] The pumping element 200, thanks to the activation portion 200b, therefore allows an operator a better control and modulation of the deformation of the deformable portion 4, thus allowing a better control of an escape of air bubbles from the mold fluid contained in the inner volume “V” of the mold 100.

[0185] According to an aspect of the invention, the pumping element 200 comprises a pair of membranes 202 delimiting the chamber and 201 , preferably, a relief hole “S” facing the chamber 202 and distal from the connecting portion 200c.

[0186] A first membrane 202a of the pair of membranes 200 is positioned close to the connecting portion 200c and is movable between an open position, wherein it places the chamber 201 in fluid communication with the inner cavity 7, and a closed position, wherein it occludes the connecting portion 200c.

[0187] A second membrane 200b of the pair of membranes is positioned in an opposite position relative to the first membrane 202a and facing the relief hole “S” in such a way as to delimit the chamber 201 .

[0188] The second membrane 202b is movable between an open position, wherein it places the chamber 201 in fluid communication with the outside environment relative to the pumping element 200 through the relief hole “S”, and a closed position, wherein it occludes the relief hole “S”.

[0189] For this reason, a movement of the first membrane 202a and / or of the second membrane 202b between the open position and the closed position determines a maintaining of a depressurisation and / or a pressurisation of the chamber 201 of the pumping element 200 and, consequently, of the inner cavity 7 of the mold 100.

[0190] Advantageously, the pumping element 200, thanks to the pair of membranes 202, makes it possible to keep the deformable portion 4 in the casting and / or compression position, facilitating an operator both in a casting of mold fluid inside the inner volume “V” and in the escape of air bubbles from the mold fluid contained in the inner volume “V” (moving the deformable portion 4 between the casting and compression positions).

[0191] Preferably, the kit comprises a mold 100 having the support portion 10 which, defining a firm and stable support of the mold 100 on a work surface, allow an operator to perform a deformation of the deformable portion 4 interacting only with the pumping element 200.

[0192] With reference to Figure 8, this invention provides a prosthesis 300, preferably a cranial prosthesis.

[0193] In accordance with one aspect of it, the prosthesis 300 is made by casting on the mold 100 described above.

[0194] The prosthesis 300 comprises a concave main body 301 , comprising a respective wall 301a and a respective edge 301 b.

[0195] Preferably, the main body 301 has the shape of a spherical or semi- spherical cap.

[0196] In accordance with one aspect of this invention, the prosthesis 300 comprises a plurality of flanges 302 positioned along the edge 301b of the main body 301 .

[0197] Advantageously, the flanges 302 facilitate an operator in the positioning of the prosthesis 300.

[0198] Preferably, the flanges 302 comprise holes (not illustrated in the accompanying drawings) passing through the flanges themselves, intended to house a suture wire.

[0199] Preferably, the flanges 302 have a thickness less than a thickness of the prosthesis 300 and are positioned in continuity with a surface of the prosthesis 300.

[0200] The prosthesis is preferably made of polymethyl methacrylate (PMMA).

[0201] This invention also provides a method for making a prosthesis, for example the prosthesis 300.

[0202] The method comprises a step of preparing a mold for prosthesis.

[0203] According to one aspect of this invention, the step of preparing a mold is performed by preparing the mold 100 described above.

[0204] The method comprises a step of closing the mold 100, by constraining the first shell 1 and the second shell 2 along the respective edges 1b, 2b, in such a way as to define an inner volume “V”, configured to contain a mold fluid. In other words, the closing step is performed by placing the first shell 1 and the second shell 2 in the closed configuration.

[0205] Preferably, the closing step is performed by placing at least one reference profile 9 of the first shell 1 facing a corresponding reference profile 9 of the second shell 2. In this way, the method ensures a correct execution of the closing step by an operator, avoiding any human errors.

[0206] The method also comprises a step of casting a mold fluid inside the inner volume ‘V’, illustrated schematically in Figure 3.

[0207] More in detail, the casting step is performed by casting the mold fluid through the opening of the mold 3.

[0208] The method also comprises a step (illustrated schematically in Figure 3) of curing the mold fluid cast into the inner volume “V” to obtain a prosthesis 300.

[0209] Upon completion of the curing of the mold fluid, the method comprises a step of opening the mold 100 (illustrated schematically in Figure 4), by at least partly spacing apart the edge 1 b of the first shell 1 and the edge 2b of the second shell 2, in such a way as to extract the prosthesis 300 obtained.

[0210] The opening step allows the prosthesis 300 to be extracted from the mold 100 without making incisions and / or without damaging the mold 100. Advantageously, the opening step favours a re-usability of the mold 100.

[0211] According to one aspect of this invention, the casting step comprises a step of moving the deformable portion 4, between the casting position, wherein the inner volume “V” has a first value, and the compression position, wherein the inner volume “V” has a second value, less than the first value.

[0212] In other words, the casting step is performed by moving the deformable portion 4 for varying the inner volume “V”,

[0213] Advantageously, the step of moving the deformable portion 4 allows the mold fluid contained in the inner volume “V” to be moved, compressing it (in the compression position) and releasing it (in the casting position); in this way an operator is able to direct any air bubbles contained in the mold fluid inside the inner volume “V” towards the mold opening 3. In other words, the step of moving the deformable portion 4 makes it possible to evacuate air bubbles from the inner volume “V” to the outside environment (relative to the inner volume “V”).

[0214] Preferably, the casting step comprises a sequence of movements of the deformable portion 4 between the casting position and the compression position.

[0215] In accordance with one aspect of this invention, the method comprises, before the casting step, a preliminary casting step. The preliminary casting step is performed by casting through the mold opening 3 in the inner volume “V”.

[0216] The preliminary casting step makes it possible to make an estimate of a quantity of mold fluid necessary for filling the inner volume “V” of the mold 100.

[0217] The preliminary casting step therefore makes it possible to avoid waste of material, as well as speed up the casting step.

[0218] Preferably, the casting step and the preliminary casting step are assisted by a funnel (not illustrated in the accompanying drawings) associated with or integrated in the mold opening 3.

[0219] According to one aspect of this invention, the method comprises a milling step after the opening step. The milling step comprises milling the prosthesis 300 obtained in such a way as to define a profile of its wall 301a.

[0220] Preferably, the milling step is carried out for levelling the surface of the wall 301a so as to make the wall free of comers.

[0221] In effect, the prosthesis obtained by a casting of resin in the mold 100 comprises a zone of irregularities “Z” (illustrated in Figure 5) located at the mold opening 3; the milling step allows the zone of irregularities “Z” to be eliminated, or at least reduced. For this reason, the milling step makes it possible to obtain a prosthesis which facilitates healing of a patient subjected cranial plastic surgery.

[0222] According to an aspect of this invention, the method comprises a step of sterilising the mold 100, carried out before the step of closing the mold 100.

[0223] This invention achieves the preset aims, overcoming the drawbacks of the prior art.

[0224] In particular, thanks to the deformable portion 4, it is possible to vary the inner volume “V” of the mold 100, in such a way as to move the mold fluid contained therein and direct any air bubbles (contained in the mold fluid) towards the mold opening 3.

[0225] Moreover, thanks to the gripping element 5, as well as thanks to the pumping element 200 and the inner cavity 7, it is possible to manually modulate a variation in the inner volume “V” of the mold 100 to control the escape of air bubbles in a easy, intuitive and facilitated manner.

[0226] A further embodiment of the mold according to the invention, as illustrated in Figures 9 to 15, is described below. It should be noted that, for the sake of brevity, the features which are common with the embodiments illustrated above will not be repeated but also extend to the embodiment described below.

[0227] With reference to Figure 9, the mold for prosthesis 100 comprises a first shell 1 , having a respective outer surface 11a and a respective edge 1 b comprising a first access portion PA1. The first shell 1 comprises a raised portion 12, which rises from the outer surface 11a. The raised portion 12 extends, starting from the edge 1b, towards the inside of the first shell 1. The raised portion 12 is interrupted at the first access portion PA1 .

[0228] The mold for prosthesis 100 comprises a second shell 2, having a base edge 2b’ and a flap 22, which rises on the peripheral edge 2b” to define a peripheral edge 2b”. The base edge 2b’ comprises a second access portion PA2. The flap 22 is interrupted at the second access position PA2. The flap 22 comprises a first portion 221 , having a first thickness and connected to the base edge 2b’, and a second portion 222, having a second thickness, connected to the first portion 221 and culminating in the peripheral edge 2b”.

[0229] Advantageously, the second thickness of the second portion 222 is greater than the first thickness of the first portion 221 . The difference in thickness between the first portion 221 and the second portion 222 defines a housing groove SA facing towards the inner volume V.

[0230] With reference to Figures 10 and 11 , the mold for prosthesis 100 is movable between a closed configuration, wherein the first shell 1 and the second shell 2 are connected to each other to define an inner volume V, configured to contain a mold fluid, and an open configuration, wherein said first shell 1 and second shell 2 are at least partly spaced from each other. In the closed configuration shown in Figure 10, the raised portion 12 is inserted inside the housing groove SA in such a way as to constrain the first shell 1 to the second shell 2.

[0231] In the open configuration shown in Figure 11 , the raised portion 12 is free from the housing groove SA.

[0232] With reference to Figures 10 and 11 , the second shell 2 comprises a gripping element 5, positioned on the outer surface 21a of the second shell 2, and is proximal to the second access portion PA2.

[0233] With reference to Figures 12 and 13, in the closed configuration of the mold, the mold 100 is movable between an insertion position PIN and a mold position PST.

[0234] With reference to Figure 12, in the mold position PST, the first access portion PA1 and the second access portion PA2 are in contact with each other to obstruct access to the inner volume V. In the mold position PST, the first access portion PA1 and the second access portion PA2 are in contact with each other but free to move relative to each other. In the mold position PST, the base edge 2b’ of the second shell 2 is in contact with the edge 1 b of the first shell 1. With reference to Figure 13, in the insertion position PIN, the first access portion PA1 and the second access portion PA2 are spaced from each other, to define an insertion opening AIN where the mold fluid is inserted. In the insertion position PIN, the base edge 2b’ of the second shell 2 remains at least partly in contact with the edge 1 b of the first shell 1 .

[0235] In the closed configuration of the mold 100, a insertion direction DIN is defined perpendicular to the insertion opening AIN.

[0236] With reference to Figures 14 and 15, the mold 100 is movable between the mold position PST and the insertion position PIN by the effect of a pressure exerted along a direction at least partly perpendicular to the insertion direction DIN, perpendicular to the insertion opening AIN. The pressure applied allows the mold to be configured in the insertion position

[0237] PIN, thereby obtaining the insertion opening AIN. The respective insertion opening AIN allows the introduction of the mold fluid inside the inner volume V, by means of an instrument (for example a spatula).

[0238] Advantageously, the insertion opening AIN is large enough that it allows the introduction of mold fluids which are viscous enough as to require the use of an instrument.

Claims

CLAIMS1. Mold (100) for prosthesis comprising:- a first shell (1 ), having a respective wall (1a) and a respective edge (1 b);- a second shell (2), having a respective wall (2a) and a respective edge (2b), wherein the mold (100) is movable between a closed configuration, wherein the first and second shells (1 , 2) are constrained to each other at respective edges (1 b, 2b) to define an inner volume (V), configured to contain a mold fluid, and an open configuration, wherein the respective edges (1 b, 2b) of said first and second shells (1 , 2) are at least partially spaced apart;- a mold opening (3) passing the wall of the first shell (1 ) to permit, in the closed mold configuration (100), a pouring of mold fluid into the inner volume (V), wherein the second shell (2) comprises a deformable portion (4), movable with respect to the first shell (1), between a casting position, wherein the inner volume (V) has a first value, and a compression position, wherein the inner volume (V) has a second value, less than the first value.

2. Mold (100) according to claim 1 comprising a gripping element (5) disposed externally to the inner volume (V) in the closed configuration, wherein the gripping element (5) is associated with the second shell (2) and is grippable to move the deformable portion (4) between the casting position and the compression position.

3. Mold (100) according to claim 1 , wherein the second shell (2) comprises a bottom wall (6) facing the deformable portion (4) and defining, with the deformable portion (4), an inner cavity (7) depressurizable and pressurizable for moving the deformable portion (4) between the casting position and the compression position, respectively.

4. Mold (100) according to claim 3, wherein the inner cavity (7) is connectable to a pumping element (200) to receive pressurized air.

5. Mold (100) according to claim 3 or 4, wherein the bottom wall (6) has a first hardness value and wherein the deformable portion (4) has a second hardness value, lower than the first hardness value.

6. Mold (100) according to any one of the preceding claims, wherein the edge (2b) of the second shell (2) comprises a lip (20), defining a housing cavity (21 ), configured to receive the edge (1 b) of the first shell (1 ) so as to define a closed end (E) of the mold (100) in the closed configuration.

7. Mold (100) according to any one of the preceding claims, wherein one between the first shell (1 ) and the second shell (2) comprises a protuberance (8) proximal to the respective edge (1 b, 2b) and facing toward the inner volume (V) in the closed configuration.

8. Mold (100) according to any of the preceding claims, wherein the first shell (1 ) and the second shell (2) comprise respective reference templates (9) facing each other in the closed configuration.

9. Mold (100) according to any one of the preceding claims, wherein the first shell (1 ) and the second shell (2) are made of high consistency silicone rubber.

10. Mold (100) according to any one of the preceding claims, wherein the first shell (1 ) and the second shell (2) are made of dimethyl-vinyl-siloxane with reinforcing silica.11 . Mold (100) according to any one of the preceding claims, comprising a support portion (10), resting on a work surface and configured to define astable support of the mold (100) on the work surface.

12. Mold (100) for prosthesis comprising:- a first shell (1 ), including an outer surface (11a), facing towards the outside of the mold (100), and a respective edge (1 b), comprising a first access portion (PA1 );- a second shell (2), comprising a base edge (2b’) and a flap (22), which rises from the base edge (2b’) to define a peripheral edge (2b”), wherein the base edge (2b’) comprises a second access portion (PA2), at which the flap (22) is interrupted, wherein the mold (100) is movable between a closed configuration, wherein the first and the second shells (1 , 2) are connected to each other to define an inner volume (V), configured to contain a mold fluid, and an open configuration, wherein said first and second shells (1 , 2) are at least partly spaced, wherein, in the closed configuration of the mold, the mold is movable between a mold position (PST) and an insertion position (PIN), wherein in the mold position (PST):(a) the first access portion (PA1 ) and the second access portion (PA2) are in contact with each other to prevent access to the inner volume (V) and;(b) the base edge (2b’) of the second shell is in contact with the edge (1b) of the first shell, and wherein in the insertion position (PIN):(a) the first access portion (PA1 ) and the second access portion (PA2) are spaced from each other to define an insertion opening (AIN) where the mold fluid is inserted, and(b) the base edge (2b’) of the second shell remains at least partly in contact with the edge (1 b) of the first shell.

13. The mold according to claim 12, wherein the first and second access portions (PA1 , PA2) are, in the mold position, in contact with each otherbut free to move relative to each other, wherein, in the closed configuration of the mold (100), the mold is movable from the mold position (PST) to the insertion position (PIN) due to a pressure exerted along a direction at least partly perpendicular to an insertion direction (DIN), perpendicular to the insertion opening (AIN).

14. The mold (100) according to claim 12 or 13, wherein the flap (22) comprises a first portion (221 ), having a first thickness and connected to the base edge (2b’), and a second portion (222), having a second thickness, connected to the first portion (221 ) and culminating in the peripheral edge (2b”), wherein the second thickness is greater than the first thickness, in such a way as to form a housing groove (SA) facing towards the inner volume, wherein the first shell (1 ) comprises a raised portion (12), which:(a) it rises from the outer surface (11a);(b) it extends, starting from the edge (1b), towards the inside of the first shell (1 ), and(c) is interrupted at the first access portion (PA1 ), said raised portion (12) being configured to be inserted inside the housing groove (SA) in the closed configuration of the mold.

15. The mold (100) according to any one of the preceding claims, comprising a gripping element (5), positioned on an outer surface (21a) of the second shell (2) and proximal to the second access portion (PA2).

16. Kit for making a prosthesis comprising:- a mold (100) according to any one of the claims from 1 to 15;- a pumping element (200), connectable to the inner cavity (7) and comprising a manually depressurizable and pressurizable chamber (201 ) to define a depressurization and pressurization of the inner cavity (7), respectively, and a pair of membranes (202) delimiting the chamber (201),configured to maintain a depressurization and / or pressurization of the chamber (201 ).

17. A cranial prosthesis (300) made by casting on the mold (100) according to any of the preceding claims, comprising:- a concave main body (301 ) comprising a respective wall (301a) and a respective edge (301 b);- a plurality of flanges (302) arranged along the edge (301 b) of the main body (301 ).

18. Method of making a prosthesis comprising the steps of:- preparing a mold (100) comprising a first shell (1 ), having a respective wall (1a) and a respective edge (1 b), and a second shell (2), having a respective wall (2a) and a respective edge (2b);- closing the mold (100), constraining the first shell (1 ) and the second shell (2) along their respective edges (1 b, 2b) in such a way as to define an inner volume (V), configured to contain a mold fluid;- casting of a mold fluid within the inner volume (V) through a mold opening (3) passing the first shell (1 );- curing of the cast mold fluid within the inner volume (V) to obtain a prosthesis (300);- opening of the mold (100) by at least partially spacing the edge (1 b) of the first shell (1 ) and the edge (2b) of the second shell (2), so as to extract the prosthesis (300) obtained; in which the casting step includes a step of moving a deformable portion (4) of the second shell (2) relative to the first shell (1 ) between a casting position, in which the inner volume (V) has a first value, and a compression position, in which the inner volume (V) has a second value, less than the first value.

19. Method of making a prosthesis comprising the steps of:- preparing a mold (100) comprising: a first shell (1 ), including an outer surface (11a), facing towards the outside of the mold (100), and a respective edge (1 b), comprising a first access portion (PA1 ); a second shell (2), comprising a base edge (2b’) and a flap, which rises from the base edge (2b’) to define a peripheral edge (2b”), wherein the base edge comprises a second access portion (PA2), at which the flap (22) is interrupted,- closing the mold (100), constraining the first shell (1 ) and the second shell (2) in such a way as to define an inner volume (V), configured to contain a mold fluid, wherein when the mold is closed, the first and the second access portions (PA1 , PA2) are in contact to prevent access to the inner volume (V1 );- spacing between the first and second access portions (PA1 , PA2), to define an insertion opening (AIN);- inserting a mold fluid into the inner volume (V) through the insertion opening (AIN);- curing of the cast mold fluid within the inner volume (V) to obtain a prosthesis (300);- opening the mold (100) by spacing at least the first shell (1 ) from the second shell (2), in such a way as to extract the prosthesis (300) obtained; wherein the step of spacing between the first and second access portions (PA1 , PA2) is performed by applying a pressure on the mold in the closed configuration along a direction perpendicular to the insertion opening (AIN).

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