CRANIAL FIXATION DEVICE FOR DECOMPRESSIVE / AUGMENTATIVE CRANIECTOMY

Abstract

A cranial fixation device for decompressive/augmentative craniectomy is described comprising a lid (4) and a plurality of brackets (3), the device being designed for the treatment of pathologies causing a herniation of the brain with a consequent increase in intracranial pressure, of the type which provides for the creation of an opening in the cranial case, by milling along a craniotomy edge (2), able to allow the expansion of the brain and the application of the lid (4) at a certain vertical distance (d) from said craniotomy rim (2) with functions of protection and containment of the brain, wherein the lid (4) is connected to the craniotomy rim (2) by the plurality of brackets (3) which are fixed simultaneously to the lid (4) and to the craniotomy rim (2).

Claims

1. Cranial fixation device for decompressive/augmentative craniectomy comprising a lid (4) and a plurality of brackets (3), said device being designed for the treatment of pathologies causing herniation of the brain with a consequent increase in intracranial pressure, of the type which provides for the creation of an opening in the cranial case, by milling along a craniotomy edge (2), able to allow the expansion of the brain and the application of said lid (4) to a certain vertical distance (d) from said craniotomy edge (2) with functions of protection and containment of the brain, characterized in that said lid (4) is connected to the craniotomy edge (2) by said plurality of brackets (3) which are fixed simultaneously to the lid (4) and to the craniotomy edge (2), said brackets (3) comprising: a central body (3a), having the function of spacer between the craniotomy edge (2) and the lid (4); and two shelves (3b) which fix said brackets (3) in the anchorage point on the skull and prevent the lid (4) from sinking.

2. Cranial fixation device for decompressive/augmentative craniectomy according to claim 1, characterized in that said cover (4) is made of synthetic material.

3. Cranial fixation device for decompressive/augmentative craniectomy according to claim 2, characterized in that said synthetic material is polymethylmethacrylate (PMMA).

4. Cranial fixation device for decompressive/augmentative craniectomy according to claim 2, characterized in that said lid (4) is made by 3D printing.

5. Cranial fixation device for decompressive/augmentative craniectomy according to claim 1, characterized in that said lid (4) is the same bone operculum taken by means of a craniotomy.

6. Cranial fixation device for decompressive/augmentative craniectomy according to claim 1, characterized in that said brackets (3) are strong enough to guarantee a seal even in the event of trauma to the head and sufficiently malleable with special pliers (5) so that it can adapt when the lid (4) is implanted.

7. Cranial fixation device for decompressive/augmentative craniectomy according to claim 6, characterized in that said brackets (3) are made of titanium.

8. Cranial fixation device for decompressive/augmentative craniectomy according to claim 6, characterized in that said brackets (3) are made of thermoplastic material.

9. Cranial fixation device for decompressive augmentative craniectomy according to claim 8, characterized in that said thermoplastic material is polyether ether ketone (PEEK) or a composite comprising carbon fibres impregnated with PEEK.

Description

[0027] The present invention will be better described by a preferred embodiment thereof, provided by way of non-limiting example, with reference to the attached drawings, in which:

[0028] FIG. 1 shows a simulacrum of the skull case;

[0029] FIG. 2 shows the device according to the invention with the operculum held in position by a plurality of brackets;

[0030] FIGS. 3 and 4 show a bracket for fixing said lid.

[0031] With reference to the attached figures, (1) indicates a simulacrum of a human skull, on which an opening has been made by milling along a craniotomy edge (2). A plurality of brackets (3) are fixed along said edge (2) by means of screws (not referenced) and a cover (4) is fixed on said brackets (3).

[0032] The brackets (3) are fixed to the skull (1) and to the lid (4) by means of screws.

[0033] These brackets (3) are made of titanium and include a central body (3a), with two shelves (31) and (32), which act as spacers, and two further shelves (3b) which fix them at the anchor point on the skull and prevent the cover from sinking (4).

[0034] In FIG. 4, the bracket (3) is shown mounted on the craniotomy edge (2) and it is highlighted how the lower shelf (31) of the central body (3a) rests on the craniotomy edge (2), while the upper shelf (32) is adapted to receive the cover (4). The position of the cover (4) is then defined by the length of the central part (3a) of the bracket (3).

[0035] The brackets (3) are strong enough to guarantee a seal even in the event of trauma to the head and malleable enough with special pliers (5) so as to be able to adapt when the lid is implanted (4).

[0036] According to another preferred embodiment, the brackets (3) are made of thermoplastic material (for example polyether ether ketonePEEK) or in composite material with a thermoplastic matrix (for example carbon fibres impregnated with PEEK or other thermoplastic polymer). In this case, to shape the brackets (3) it is necessary to heat them adequately.

[0037] According to a further preferred embodiment, said lid (4) is the same bone coming from the craniotomy. It can be made in other ways, for example by 3D printing in a biocompatible synthetic material, for example polymethyl methacrylate (PMMA)

[0038] FIG. 1 highlights the part of the braincase on which the opening that allows the brain to herniate has been made, while FIG. 2 shows the skull with the opening to which the lid (4) has been applied, with a protective function of the brain but in a suitable position to provide the brain itself with the space it needs to herniate without exerting any effort.

[0039] As is clear from the preceding description, the fundamental technical problem faced has been completely solved, since the device according to the invention defines a space for free herniation of the brain.

[0040] In summary, the device of the invention serves for a cranial fixation for decompressive/augmentative craniectomy and comprises a lid (4) and a plurality of brackets (3), the device being designed for the treatment of pathologies which cause a herniation of the brain with a consequent increase in intracranial pressure, of the type which provides for the creation of an opening in the cranial case, by means of milling along a craniotomy edge (2), able to allow the expansion of the brain and the application of the lid (4) at a certain distance (d) vertically from the craniotomy edge (2) with functions of protection and containment of the brain, wherein the lid (4) is connected to the craniotomy edge (2) by the plurality of brackets (3) which are fixed simultaneously to the lid (4) and to the craniotomy edge (2), the brackets (3) comprising: [0041] a central body (3a), having the function of spacer between the craniotomy edge (2) and the lid (4); and [0042] two shelves (3b) which fix the brackets (3) in the anchorage point on the skull and prevent the lid from sinking (4).

[0043] Preferably, in the device indicated above, the lid (4) is made of synthetic material, in particular polymethyl methacrylate (PMMA).

[0044] Preferably, the lid (4) is made by 3D printing.

[0045] As a variant, in the device of the invention, the lid (4) can be the same bone operculum taken by means of a craniotomy.

[0046] The brackets (3) are strong enough to guarantee a seal even in the event of trauma to the head and are malleable enough with special pliers (5) so as to be able to adapt when the lid is implanted (4); in particular, the brackets (3) are made of titanium, or of thermoplastic material, again in particular this thermoplastic material is polyether ether ketone (PEEK) or a composite comprising carbon fibres impregnated with PEEK.