WO2014097212A1

WO2014097212A1 - Cranial protection

Info

Publication number: WO2014097212A1
Application number: PCT/IB2013/061145
Authority: WO
Inventors: Martina BONOMELLI
Original assignee: Mako Shark S.R.L.
Priority date: 2012-12-21
Filing date: 2013-12-19
Publication date: 2014-06-26
Also published as: ITMI20122224A1

Abstract

The present invention relates to a cranial protection comprising a shell (11) substantially semi-spherical in shape defining a bottom edge (12), said shell (1 1) comprising at least two layers (13, 14) made of a material that is not completely rigid, superimposed on and positioned next to one another, each layer (13, 14) being provided with a plurality of openings (15) that extend from said bottom edge (12) toward the top part of the shell (1 1), there being provided fastening means (16) adapted to maintain said layers (13, 14) positioned next to one another and arranged in such a manner that the openings (14) of at least two layers (13, 14) are mutually staggered.

Description

TITLE

"CRANIAL PROTECTION"

DESCRIPTION

The present invention relates to a cranial protection and in particular to a universal cranial protection for people who require to protect the skull from knocks, impacts and the like, such as patients who have undergone surgery, or people who suffer from epilepsy.

In the field of surgery, in several situations it is necessary to perform a craniotomy or a cranial resection, i.e. the removal of a smaller or larger portion of the cranial bone, for example to operate on tumors or aneurysms in the brain.

At times it is also necessary to remove a piece of cranial bone following an accident in order to reduce the excessive pressure that the neurocranium can generate on parts of the brain with hematomas or hemorrhages.

However, it has recently been shown that the neurological conditions of a patient can improve if a cranioplasty is also subsequently performed (i.e. restoration to the natural conditions of the cranial theca), repositioning the previously removed original piece of bone or one made of synthetic material.

This second surgery is generally carried out after a few months, when the patient has fully recovered from the main surgery.

Consequently, during this period (before the reconstruction) and in the period immediately afterwards, the skull must be suitably protected, above all in the area temporarily not protected by bone.

To date there are no known effective devices that are capable of offering the patient both adequate protection and a high level of comfort.

For example, in many cases, cycling helmets are used as postoperative protective helmets, as they are easy to obtain, are available in different sizes and have relatively limited costs. However, although these devices are more that suitable for the use for which they were designed, have numerous limitations when used as postoperative helmets.

Firstly, the external profile has a particularly bulky shape which, besides the aesthetic factor, is particularly awkward when the patient wishes to rest his/her head on a pillow (often the protection must also be worn at night), on a sofa or on a vehicle headrest.

Moreover, this shape mainly offers protection in the frontal and parietal area of the neurocranium, while it leaves the temporal and occipital area partly unprotected; when the craniotomy or cranial resection concerns these second areas, the protection must be worn tilted with respect to the natural position in order to adequately cover the area of the operation.

Finally, these helmets generally have no internal padding (as the shell itself is made of a deformable and shock absorbing material); consequently the whole of the inside of the shell remains substantially in contact with the skull and therefore also with the damaged area, on which instead no loads or pressures should be exerted.

Protective helmets to be used as postoperative helmets are also known on the market.

These are composed of plastic shells, structured to completely surround the neurocranium, provided with internal padding in the form of adhesive foam strips that can be glued to the inside of the shell directly by the physician (or by the patient) in the most suitable areas.

However, also these known protective devices have certain limitations.

In fact, these helmets are only available with a single size of outer shell. This is because, as these are objects with a relatively limited distribution, the production of shells of different sizes (even up to 7 or 8, as is the case for sports helmets) would entail excessive costs (for molds, etc.) which would be difficult to absorb due to the low sales volumes. In these cases, the shell is adapted to the patient's skull by varying the thickness of the internal padding by attaching a varying number of strips superimposed. The problem is that the shell is generally relatively large in size to allow it to be worn by adults with medium-large skulls, while also remaining at a distance of at least one or two centimeters from the surface to avoid contact with the areas involved by surgery.

Besides being unstable for patients with a small skull, due to the high thickness of the padding, a shell with this structure is also awkward when the patient wishes to rest his/her head against something.

Similar problems also occur frequently for people affected by epilepsy, who are obliged to wear protection for several hours a day in order to prevent serious injuries caused by falls occurring during an epileptic fit.

Also in these cases, the improper use of cycling helmets, with all the disadvantages listed above, or of climbing helmets or the like, is resorted to.

In this context, the aim of the present invention is to propose a cranial protection that overcomes the aforementioned problems of the prior art.

In particular, an object of the present invention is to produce a cranial protection that is not too bulky and is comfortable for the wearer.

More in detail, the object of the present invention is to produce a cranial protection provided with a shell that is capable of adapting to different shapes and dimensions of people's skull, reducing the external overall dimensions to a minimum.

Another object of the present invention is to provide a cranial protection of limited weight, which at the same time offers adequate protection to the skull and in particular to the area involved by surgical operations or the like.

These objects are substantially achieved by a cranial protection comprising a shell substantially semi-spherical in shape defining a bottom edge, said shell comprising at least two layers made of a material that is not completely rigid, superimposed on and positioned next to one another, each layer being provided with a plurality of openings that extend from said bottom edge toward the top part of the shell, there being provided fastening means adapted to maintain said layers positioned next to one another and arranged in such a manner that the openings of at least two layers are mutually staggered.

In practice, the layers of the shell are arranged so that each opening of one layer is covered by the material of another layer; in this way, the shell has, as a whole, a substantially continuous surface without slits or the like.

The function of said openings is that of enabling the shell to deform easily in radial direction, thereby varying the extension of the bottom edge or the internal volume of this shell.

The protection thus structured, with the same shell, can therefore be worn by patients with skulls of different dimensions, each time assuming the smallest dimension necessary, limiting the overall dimensions to a minimum.

In detail, said openings can have the form of a spherical semi-lune. In practice, said openings can comprise slits with a width decreasing from the bottom edge toward the top part of the shell.

The shell thus configured therefore has high elasticity in radial direction, i.e. on the plane on which the base perimeter lies, while maintaining adequate crush resistance in the other directions.

According to a preferred variant, each layer comprises at least four of said openings. These preferably extend for a height comprised between 50 % and 90% of the height of the shell, with a total surface comprised between 20% and 50% of the surface of the shell.

Said openings thus contribute to lightening the shell, without invalidating its strength, further improving the comfort of the wearer.

Further characteristics and advantages of the present invention will become more apparent from the following indicative, and therefore non-limiting, description of an example of a preferred but not exclusive embodiment of a cranial protection, as illustrated in the accompanying drawings, in which: • Fig. 1 is a perspective view of a cranial protection according to an embodiment of the invention;

• Fig. 2 is an exploded view of the cranial protection of Fig. 1 ;

• Fig. 3 is a sectional view of the cranial protection of Fig. 1 ;

With reference to the accompanying figures, the cranial protection, indicated as a whole with 10, comprises a shell 1 1 substantially semi-spherical in shape delimited by a bottom edge 12, adapted to be positioned on a person's skull to protect it from impacts, knocks, crushing or the like.

Said bottom edge 12 can have different shapes according to the requirements and to the application of the cranial protection (postoperative, for epilepsy sufferers, etc.). For example, the bottom edge 12 can have a substantially circular shape or can be shaped so that said shell 1 1 covers, or leaves uncovered, given areas of the skull.

In the embodiment illustrated in Fig. 1, said shell 11 has the shape of a helmet that substantially covers the top and back (frontal, parietal and occipital) cranial bones and partly covers the temporal bones.

More in detail, the shell 1 1 comprises at least two layers 13 and 14, made of a material that is not completely rigid, superimposed on one another. Even more in detail, said layers 13, 14 are positioned next to one another so that their surfaces are mutually in contact but are not joined for the whole of the extension thereof (Fig. 3).

According to the invention, said layers 13, 14 of the shell 1 1 are provided with a plurality of openings 15 that extend from said bottom edge 12 toward the upper part of said shell.

Said openings 15 can comprise, for example, slits with a width that is substantially constant or, preferably, decreasing from the bottom edge 12 toward the top part of the shell.

In a preferred variant, said openings 15 can have the form of a spherical semi-lune delimited by two lateral edges 15a and a lower edge 15b that lies on the bottom edge 12 (Fig. 2).

However, according to the invention, said layers 13, 14 are arranged so that an opening 15 of one layer is covered by at least a portion of another layer of material.

In practice, said layers 13 and 14 are positioned so that said openings 15 are mutually staggered and the shell 1 1 , as a whole, has a substantially closed surface with no slits, as can be seen in Fig. 1.

For this purpose, the shell 1 1 is provided with fastening means 16 configured to maintain said layers 13, 14 positioned next to one another and to prevent rotation of one layer with respect to the another.

According to a variant of embodiment, said fastening means 16 can be of removable type to allow detachment and maintenance of the protection, such as tear off devices, press studs, screws or the like, or of fixed type, such as adhesives, rivets or the like. Preferably, said fastening means 16 are positioned in the top part of the shell 1 1, i.e. in an area of the layers 13, 14 not affected by the openings 15.

According to the principle of the invention, said openings 15, being positioned at the bottom edge 12, interrupt it, significantly reducing the crush and expansion resistance of the shell 1 1 in radial direction. In practice, said openings 15 enable the shell to deform, more or less freely, in radial direction, varying the extension of the bottom edge 12, i.e. the inner volume of the shell.

Consequently, the cranial protection thus structured can be worn by anyone, as it can expand from a non-deformed condition, in which it defines a minimum inner volume, to a condition of use in which it expands to a greater or lesser degree to cover skulls of different dimensions.

Moreover, the partial elasticity of the material means that, in expanded condition, the shell 1 1 exerts a light pressure on the skull, enabling the protection both to adhere and adapt perfectly to skulls of different shapes and dimensions, and to reduce the external overall dimensions of the cranial protection to a minimum.

The greater or lesser ability to deform of the shell 11 (expansion) depends on the number, the shape and the dimension of the openings 15 provided in the layers 13, 14, and on the material with which these latter are made.

Advantageously, the layers 13, 14 can be made of a composite material, such as carbon fiber, Kevlar, fiberglass or the like, which ensures high strength despite the very limited specific weight.

To ensure both high resistance to impacts and low weight, said layers 13, 14, if made of one of the aforementioned fibers, can have a thickness comprised between 0.2 mm and 3 mm.

The cranial protection thus configured is particularly light and comfortable to wear with respect to prior art protections.

For good functionality of the protection, each layer 13, 14 is preferably provided with at least three openings 15 and more preferably with at least four openings 15. Advantageously, to provide uniform flexibility throughout the shell 1 1 , said openings 15 can be spaced substantially equidistant from one another.

In particular, a good compromise between high expansion capacity of the shell 1 1 and adequate pressure exerted by the shell on the skull is obtained with openings 15 that can extend for a height comprised between 50% and 98% of the height of the shell.

Improved performances are obtained with openings 15 that extend for a height comprised between 75% and 98% of the height of the shell.

The same performances are achieved with openings 15 that occupy a total surface comprised between 20% and 50% of the surface of the shell.

Preferably, to ensure even greater comfort for the wearer, pads 17 made of soft material are applied to the inner surface of the shell 1 1. Advantageously said pads 17 are connected to the surface by means of removable connection means 18; in this way it is possible to remove one or more pads in areas of the skull to which no pressure is to be applied, such as areas involved by cranial resection or cranioplasty operations,

Said removable connection means 18 can be selected from tear-off devices, press studs, magnets or the like.

According to a variant, at least one hole 19 is provided in the upper part of the shell 1 1 to create air recirculation in the gap 20 between the inner surface of the shell, which is slightly spaced from the skull by pads 17, and the skull itself. In this way, fresh air can enter the shell from the bottom edge 12 and can exit through said hole 19.

For the same purpose, according to a further variant, said shell 11, i.e. the related layers, can be partially perforated to ensure greater breathability, useful when the protection must be worn for several hours a day.

Optionally, the cranial protection can also be provided with retaining means 20, such as a strap or the like, useful for preventing the protection from detaching from the skull in the case of falls or violent knocks.

According to another variant, the outer surface of the shell 1 1 can be covered externally with a coating made of an elastic and breathable material (not shown in the figure), such as a fabric or the like. This coating makes it possible to give the protection a less conspicuous appearance, in the case in which it is desirable for it to he less visible, or to personalize it with designs and colors when the protection is to be worn by children or youths.

The present invention, as described and illustrated, may be subject to various modifications and variants, all of which fall within the scope of the invention; furthermore, all the details may be replaced with other technically equivalent elements.

Claims

1. A cranial protection comprising a shell (1 1) substantially semi-spherical in shape defining a bottom edge (12), said shell (11) comprising at least two layers (13, 14) made of a material that is not completely rigid, superimposed on and positioned next to one another, each layer (13, 14) being provided with a plurality of openings (15) that extend from said bottom edge (12) toward the top part of the shell (1 1), there being provided fastening means (16) adapted to maintain said layers (13, 14) positioned next to one another and arranged in such a manner that the openings (14) of at least two layers (13, 14) are mutually staggered. .

2. The cranial protection according to claim 1, characterized in that said openings (15) comprise slits with a width decreasing from the bottom edge (12) toward the top part of the shell (1 1).

3. The cranial protection according to claim 1 or 2, characterized in that said openings (15) extend for a height comprised between 50% and 90% of the height of the shell (11).

4. The cranial protection according to any one of the preceding claims, characterized in that said openings (15) occupy a total surface comprised between 20% and 50% of the surface of the shell (11).

5. The cranial protection according to any one of the preceding claims, characterized in that each layer (13, 14) is provided with at least four of said openings (15) spaced substantially equidistant from one another.

6. The cranial protection according to any one of the preceding claims, characterized in that said fastening means (16) adapted to maintain the layers (13, 14) of the shell (1 1) positioned next to one another and in position are selected from tear off devices, press studs, screws, adhesives or rivets.

7. The cranial protection according to any one of the preceding claims, characterized in that said layers (13, 14) have at least one hole (19) in the upper part of the shell (1 1).

8. The cranial protection according to any one of the preceding claims, characterized in that said layers (13, 14) are partly perforated.

9. The cranial protection according to any one of the preceding claims, characterized in that there are provided pads (17) of soft material on the inner surface of the shell (11), said pads ( 17) being connected by means of removable connection means (18).

10. The cranial protection according to claim 9, characterized in that said connection means (18) are selected from tear-off devices, press studs or magnets.

11. The cranial protection according to any one of the preceding claims, characterized in that the outside of said shell (11), is covered at least partly with a coating of an elastic and breathable material.

12. The cranial protection according to any one of the preceding claims, characterized in that said layers (13, 14) are made of a material selected from carbon fiber, Kevlar or fiberglass.

13. The cranial protection according to any one of the preceding claims, characterized in that said layers (13, 14) have a thickness comprised between 0.2 mm and 3 mm.