ES1297378U - Cranial orthosis (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

Cranial orthosis, characterized in that it comprises a central body (1) intended for placement between the parietal and occipital bones, padded, with two lateral wings (3), symmetrical that each carry removable and/or thick pads (4). adjustable. (Machine-translation by Google Translate, not legally binding)

Description

DESCRIPTION

cranial orthosis

TECHNIQUE SECTOR

The present invention relates to a semivalve cranial orthosis intended for the correction of malpositioning of the skull bones in babies from 0 to 4 months. It is designed for the prevention and treatment of cranial deformities called positional plagiocephaly, brachycephaly and scaphocephaly.

STATE OF THE ART

The baby's skull is highly moldable in the last months of pregnancy and the first 3-4 months of life. Normally the deformed skull of the newborn recovers the normal oval shape after delivery in a few hours, days or weeks. However, between 10-14% maintain a moderate or severe deformity upon reaching 4 months of age. Without adequate treatment before this age, his deformity will live into adulthood or will need to be treated with a classic cranial orthosis.

Apart from the unsightly effect of a permanent deformity, the deformity may have repercussions on the neurological maturation of affected babies. It can produce mechanical, maxillofacial, cervico-facial and cognitive complications. They also cause a higher frequency of otitis media, response deficits to auditory cognitive evoked potentials, astigmatism, mandibular asymmetries, and language delay.

Until now, the protocols based on the publications of the American Academy of Pediatrics consist of advising the repositioning technique before 4 months of age and treatment with custom-made and personalized cranial orthoses from 4 months of age.

The repositioning technique consists of: 1) homogeneously distributing the weight of the newborn's head during rest in the cradle in the supine position over 180° from right to left, modifying the support area every 3- 4 hours, 2) increase the baby's tummy time during wakefulness and low surveillance and 3) perform neck exercises in case of coincidence with congenital muscular torticollis. This technique is advisable from the first day of life.

The orthopedic treatment of cranial deformities for babies older than 4 months was born in 1986 when the company Cranial Technologies Inc. (Temple, AZ, USA) laid the foundations for the systematized treatment protocol with its dynamic cranial orthosis called DOC Band ® . Despite the high incidence of cases, the US Food and Drug Administration did not approve such treatment until 1998. In 2003, the American Academy of Pediatrics published that the ideal age for treatment with cranial orthosis is between 4 and 12 months. Cranial Technologies introduced the concept of active or dynamic cranial orthoses (which require frequent retouching) and later other manufacturers the concept of passive cranial orthoses that require little correction during wear.

Convinced that there is a gap between birth and 4 months of age in which action should be taken to prevent the appearance of cranial deformities, our invention consists in the use of a passive posterior semi-leaflet orthosis to rest the baby's skull that Avoid or treat the cranial deformity if it has already appeared in order to avoid or reduce as much as possible the need to resort to the use of a classic closed cranial orthosis after 4 months.

The applicant does not know of any orthopedic solution to these mentioned problems and in these ages from 0 to 4 months that can be considered similar to the invention.

BRIEF EXPLANATION OF THE INVENTION

The invention consists of a cranial orthosis according to the claims. Its different embodiments solve the problems of the state of the art and provide notable advantages.

It makes it possible to cover a large gap in terms of advice to be given to parents of newborns and even more so about effective measures to prevent deformities detected between 0 and 4 months from ending up having access to orthopedic treatment.

It is a simple measure to prevent deformities at this age and that, to the repositioning treatment, the use of an orthopedic instrument can be added. invasive, non-dangerous, non-permanent, which helps the baby's skull not to deform or to correct itself if it is already deformed.

For this, a cranial orthosis has been designed for the prevention and non-invasive or permanent treatment of cranial deformities in babies from 0 to 4. It is an open and passive cranial splint that has been designed with a double purpose: to prevent and correct the prenatal and postnatal skull deformities diagnosed in newborns and infants 0 to 4 months.

It is based on the fact that in the first months of life the baby's brain and skull grow very rapidly, about one centimeter per month, and its hemispherical valve shape applied to the back of the skull when the baby is in the crib allows its use in this period in which babies still move little and have not yet learned to tilt and turn.

The effect of the orthosis imitates the shape of the cup of the adult's hand that supports the newborn's head, freeing the back of the skull from any type of pressure. It is not indicated beyond 4 months of age and neither is it in those babies, younger than this age, who already turn frequently or turn over spontaneously.

If a certain degree of posterior flattening of the skull persists beyond 4 months, the use of classic dynamic cranial orthoses already on the market should be considered.

The low economic cost of using the invention must also be assessed, compared to the cost in time, money and displacement of babies over four months treated with classic orthopedic methods. In some cases of mild cranial deformities, simple repositioning of the baby, avoiding support on the flattened occiput, may be effective, but this conservative option loses effectiveness in asymmetries greater than 10 mm or with a cranial index greater than 90 and in babies approaching 3-4 months of age.

The invention does not exert any active pressure on the developing skull. On the contrary, it leaves the posterior area of the skull free as it remains in complete bilateral suspension (brachycephaly) or incomplete unilateral suspension (plagiocephaly). In these cases A large part of the weight of the head rests on the lateral areas of the invention, on which the two temporal regions of the skull that are not deformable are supported.

Only in the case of scaphocephaly the entire weight of the skull rests at the occipital level, but this pressure is the same natural pressure experienced by any other baby who sleeps on the neck and which is none other than that dictated by Newton's law.

The invention does not limit any growth by direct pressure but distributes the weight of the head so that the areas to grow are completely free of pressure. The only negative effect to be considered is the possible increased perspiration and creation of heat rashes in the area where perspiration accumulates.

The proposed cranial orthosis comprises a central body intended for placement between the parietal and occipital bones, padded with a removable cushion. It has two symmetrical side wings that each carry removable pads and/or adjustable thickness to ensure the stability of the system. The central body is normally semi-rigid, for example, made of biocompatible plastic (HDPE, PET...). For example, the pad may be a pocket into which sheets or soft discs of different thickness are inserted for lateral adjustment on the baby's head. The discs can all be the same or of different widths.

Preferably, the pads have an insert for coupling to the wing that provides the necessary rigidity to prevent accidental disassembly.

Other variants will show up in the rest of the memory.

DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, the following figures are included.

Figure 1: Schematic side view of the central body, according to one embodiment.

Figure 2: Schematic bottom view of the orthosis according to the previous embodiment.

Figure 3: Side view of the example of figure 1 attached to the head of a child. The pads have been removed to better appreciate the position.

MODES OF CARRYING OUT THE INVENTION

An embodiment of the invention is briefly described below, as an illustrative and non-limiting example of the invention, applied to the field of ceramic components.

Figures 1 and 2 show an example of a cranial orthosis formed by a central body (1) intended for placement between the parietal and occipital bones, at the rear of the skull. This central body (1) is padded, preferably with a removable cushion (2). Two symmetrical wings (3) are arranged on the sides. On each wing (3) a pad (4) or protection of the temporal region can be removably fixed. The pads (4) can be fixed, but their thickness can be adjusted, for example by removing or inserting discs or sheets inside. Each pad (4) normally has an inner insert for coupling with the respective wing (3). The pads (4) will be adjusted according to the age, the cranial perimeter and the type of deformation of the baby and its evolution. In this way, as the baby grows and the deformation is corrected, the pad (4) is changed for another more suitable for the baby's condition. It also allows cleaning of the pad (4).

Figure 1 shows a way of making the wings (3), with a lateral notch (31) to fit the corresponding pad (4). It can also be seen that the central body (1) has a curved recess (11) for the baby's neck.

Depending on the pads (4) and cushion (2) used, the three basic types of positional cranial deformities can be corrected: plagiocephaly, brachycephaly and scaphocephaly. It is only necessary to adapt them based on the baby's deformity, based on the instructions of the medical staff and the product.

In use, the infant's head is placed within the orthosis during rest in the supine position, both day and night. This allows for a suspension of the back of the skull and a significant correction of positional and other plagiocephaly. With a single orthosis, adapted, for 45-90 days and 12-18 hours a day, any deformation will be corrected.

Claims (1)

1- Cranial orthosis, characterized in that it comprises a central body (1) intended for placement between the parietal and occipital bones, padded, with two lateral wings (3), symmetrical that each carry removable and/or thick pads (4). adjustable. 2- Cranial orthosis, according to claim 1, characterized in that the central body (1) is padded with a removable cushion (2). 3- Cranial orthosis, according to claim 1, characterized in that the pads (4) have an insert for coupling to the wing (3). 4- Cranial orthosis, according to claim 1, characterized in that the wings (3) have a lateral notch (31) to fit the corresponding pad (4). 5- Cranial orthosis, according to claim 1, characterized in that the central body (1) has a curved recess (11) for the neck. 6- Cranial orthosis, according to claim 1, characterized in that the pads (4) comprise removable discs to adjust the thickness.