WO2011007027A1

WO2011007027A1 - Personalized teat for breast-fed babies with a cleft palate

Info

Publication number: WO2011007027A1
Application number: PCT/ES2010/000308
Authority: WO
Inventors: Concepción MARTÍNEZ ÁLVAREZ; Elena MARTÍNEZ SANZ; Inmaculada CASADO GÓMEZ; Concepción MARTÍN ÁLVARO
Original assignee: Universidad Complutense De Madrid
Priority date: 2009-07-17
Filing date: 2010-07-16
Publication date: 2011-01-20
Also published as: ES2352493A1; ES2352493B2

Abstract

The present invention relates to teats that are specially designed for breast-fed babies, of any species, with a cleft palate. The tip of these teats is longer than that of a standard teat and the palate side forms a dihedral angle, the vertex of which is truncated in order to form a raised band that attaches to the breast-fed babys palate cleft, thereby preventing milk from passing to the airway, thus preventing aspiration pneumonia and other, associated infections. The invention likewise relates to the method for producing these teats by obtaining a mould of the cleft palate and using heat-mouldable plastic sheets and a thermo-vacuum machine. The personalized teats can be used when feeding babies and the young of not only companion animals of particular economic value, but also experimental animals, allowing the creation of an animal-experimentation model for the study of this extremely complex pathology.

Description

TITLE

Individualized teat for infants with palatal fissure.

SECTOR OF THE TECHNIQUE

The invention falls within the sector of the manufacture of teats for feeding infants. More specifically, it refers to teats for feeding infants with palatal fissure, both human and animal.

OBJECT OF THE INVENTION

The teats of the invention are adapted to each palate and are capable of sealing the oronasal communication in each particular case. These teats, used to feed infants with palatal fissure, by adapting to the malformation in each particular case, effectively prevent the passage of milk into the airway and thus avoid aspiration pneumonia and minimize other respiratory infections.

STATE OF THE TECHNIQUE

The palatal fissure is one of the most frequent congenital malformations, described in all mammals (Ferguson MWJ. 1981. Developmental mechanisms in normal and abnormal palate formation with particular reference to the aetiology, pathogenesis and prevention of cleft palate. Br J Orthod 8: 115-137; Ferguson MWJ.

1981. Review: the valué of the American alligator (Alligator mississippiensis) as a model for research in craniofacial development. J Craniofac Genet Dev Biol 1: 123-144). Multifactorial etiology, is caused by a failure in the embryological development of the orofacial area, so that the palatine and / or the premaxilla processes do not develop and / or merge properly and the oral and nasal cavities are abnormally communicated through the opening of the palate (Ferguson MWJ.

1988. Palate Development. Development 103 (Suppl): 41-60). The main risk of this defect is the passage of food into the airway, which can be fatal if aspiration pneumonia occurs and, in the best case, cause respiratory infections of various considerations (Waldron DR, Martin RA. 1991. Cleft palate repair Probl Vet Med 3 (2): 142-152). Currently, the treatment of this pathology is essentially surgical. Thus, although in many cases several surgeries are necessary throughout the life of the individual, the first one is always performed during the first months of life, when the general state of health allows it. For this, it is essential that the newborn is properly fed and has developed the minimum possible infections. Specialists recommend, according to the severity of the defect, different feeding techniques based primarily on the position of the infant (Kasten EF, Schmidt SP, Zickler CF, Berner E, Damián LA, Christian GM, Workman H, Freeman M, Farley MD, Hicks TL 2008. Team care of the patient with cleft lip and palate Curr Probl Pediatr Adolesc Health Care 38 (5): 138-158). However, in the case of non-human mammals, most veterinarians recommend practicing euthanasia, since, in the absence of a reliable feeding method, the risk of death is very high, requiring much sacrifice and attention from breeders to take the puppies forward (Kemp C, Thiele H ₁ Dankof A, Schmidt G, Lauster C, Fernahl G, Lauster R. 2009. Cleft lip and / or palate with monogenic autosomal recessive transmission in Pyrenees shepherd dogs. Cleft Palate Craniofac J 46 (1): 81-88).

So far, to feed children with palatal fissure, standard teats or standardized special teats for cracks, wider and flattened than normal teats are used. This makes rhinitis and otitis media very frequent, since milk penetrates very easily into the nasal cavity, requiring the administration of antibiotics persistently.

Among the special teats for babies with palatal fissure, patent US4632263A refers to a nipple incorporating a convex extension that occludes the cleft palate. In addition, it provides different nipple sizes to adapt to the growth of the baby. US4856663A describes a nipple specially designed for babies with palatal fissure so that they are capable of sucking. It is characterized by the shape of a duckbill and can be used as a bottle nipple, as a pacifier nipple or placed on the mother's chest to facilitate breastfeeding. On the other hand, in patent US6968964B2, to adapt the teat to babies with cleft palate, two similar projections are added to flaps along the teat so that they form an artificial palate.

The NÜK company markets a special nipple for palatal fissure that covers the fissure and is sold without an exit hole (ES207949T3) and Medela also markets a nipple especially suitable for children with palatal fissure, Down syndrome or other neurological disorders.

In other mammals it is common for the animal to be sacrificed, because the chances of survival with oral feeding (syringe introduced directly into the mouth or in a standard nipple in which milk is gradually injected) are minimal and death occurs due to aspiration pneumonia .

In veterinary clinic, if you want to save the life of the puppy with palatal fissure, the best current way to feed it is to perform orogastric intubation for each shot (which in the first days of life must be done every two hours) or, to have a way For permanent feeding, place a probe to the stomach with entry into the pharynx through the neck. This system is removed at the end of breastfeeding. The orogastric intubation in each shot has the difficulty of handling, since it requires a lot of training by the person who does it, with the risk of producing, otherwise, an injury. Probing through the neck requires surgery and is an open door to possible infections (Hennwood Labradors. Cleft Palate Instructions. Available online: http://members.tripod.com/hennwood/id88.htm; accessed January 13 of 2009).

DESCRIPTION OF THE INVENTION

The teat that we present here, made to measure for each individual, animal or human, allows a high security against the risk of aspiration during breastfeeding, as it adapts individually obliterating the communication defect and allows the milk to pass directly towards the pharynx. This represents a very important advance in three aspects. In the case of cracked babies, it will greatly facilitate the work of breastfeeding to parents, increasing their safety in the care of these children. For many animals it will be the difference between life or death, because in this way they will be able to survive what is necessary to perform the palatoplasty or defect repair surgery. Finally, the development of this new feeding technique will allow to start and standardize the care of large animal models of study of the palatal fissure where to investigate and make new advances in the treatment of this malformation, since in humans its consequences Pathological, aesthetic and psychosocial are still a serious problem that conventional surgical techniques have not yet overcome. Currently, to investigate new therapies in relation to the palatal fissure or are performed directly in babies or the fissure is created surgically (usually in dogs) to then repair it, which generates a new confounding factor and hinders the interpretation and feasibility of the results derived from the studies . In this sense, a natural model of cracked and fed animals will be a great advantage. It must be said that the actual surgical closure of the palatal fissure still entails associated complex pathology, such as fistulas, facial growth disorders, ear, nose, throat, dental and aesthetic problems, which cause these patients to suffer the consequences of this malformation until The adult age, so it is necessary to have experimental animals fed safely to investigate new therapeutic options in them and in humans.

One aspect of the present invention relates to an individualized bottle nipple tailored to feed infants with palatal fissure, including man, without risk of pulmonary aspiration and minimizing the appearance of rhinitis and otitis media suffered by these patients. The great advance that involves the development of this nipple is that, because it is made to measure of the entire palate of the infant, when sucking it and pressing with the tongue the teat to obtain the liquid, the fissure is covered and food does not enter The nostrils. Optionally, the orifice or the holes for liquid outflow can be practiced not on the tip of the nipple but on the lingual surface thereof, which makes it much more difficult for a passage to the airway to occur. The nipple is made to measure the infant's palate, and must be replaced periodically, making a new one with different intervals according to the growth of the palate in each species. This new lactation tool can be used in any mammal that has a palatal fissure of any type, being more interesting for those with full fissure, since the chances of pulmonary aspiration are greater in these cases.

Once manufactured, its placement, use and cleaning are identical to those of a normal nipple. The custom teats created with this method are perfectly adapted to a conventional bottle, since modifications with respect to a standard nipple are made in the palatal face and in the tip of the nipple while the end of bottle attachment can be exactly same as a standard nipple.

In the present invention, "palatal face" of the teat means the surface of the teat that is in contact with the infant's palate when the teat is introduced into its mouth. Similarly, in this invention, the "lingual face" of the nipple It is the surface of the nipple that is in contact with the infant's tongue when the nipple is introduced into the mouth thereof. The term "tip" of the nipple, in the present invention, refers to the end of the nipple opposite the end by which it joins the bottle.

For the manufacture of the individualized teats an impression of the palate of the patient is made in a material for printing for dental use, such as addition silicones, alginates for dental use, condensation silicones or polyethers. These materials preferably use addition silicones or heavy silicones. This impression is used to obtain an emptying thereof in plaster, so that a plaster mold is generated that is the positive of the cracked palate. Preferably "stone" casts (types III, IV and V) are used due to their hardness. On the other hand, a solid mold is obtained that reproduces the shape of a standard nipple in a suitable material, such as heavy silicone. In the present invention we will call this solid mold as "solid filling" to differentiate it from other molds used in the same invention. To easily prepare the solid filling, the material of choice can be introduced into a previously manufactured teat with a standard shape. Next, more silicone is added to the tip of this solid filling to obtain a prolonged tip, and it is molded so that this prolonged tip adapts to the plaster mold that is the positive of the cracked palate, so that the solid filling has a elevated strip that corresponds to the fissure of the infant's palate. Using a thermo vacuum machine, the teats made of thermoformable plastic of flexible consistency on the mold made by molding the elongated tip of the solid filling with the plaster mold are obtained.

These teats have a longer tip than standard teats; In this way, when introduced into the mouth of the infant, the tip reaches to cover the previous three quarters of the hard palate. On the other hand, the palatine face of the teat forms a dihedral angle whose vertex is truncated, a vertex that is coupled to the cleft of the palate of the specific infant to be fed. This truncated vertex forms an elevated strip on the palatal surface of the nipple and, being located longitudinally along two thirds of the palatine face of the nipple from the tip, reproduces the cleft palate, so that its width and their height is irregular and of millimeter dimensions in the teats manufactured for the animal species of reduced size, while in species such as human and larger they reach dimensions of up to 2-4 cm.

When manufactured specifically for a specific palate, a single infant needs more than one nipple throughout its lactation period so that, at all times, the raised fringe of the nipple corresponds to the cleft palate. In general, at least three teats of increasing size will be necessary to cover the period of breastfeeding, the size of the teats being adapted to the increase in the size of the oral cavity.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1. Represents the palate mold (A) of a dog with a palatal fissure made in plaster from the impression of the palate in silicone. The letter B indicates the position of the palatal fissure.

Figure 2. Represents the next step in the elaboration of the nipple from the use of a standard nipple (C), the solid filling of the standard nipple in silicone (D) and the expansion of the solid nipple by adding more silicone to the tip (E).

Figure 3. Indicates the use of the mold made in plaster (A) to mold the elongated tip of the solid silicone filling (E).

Figure 4. It shows three teats of increasing size (F, G, H) in palatine vision and the elevated strip (I) that corresponds to the fissure of the palate of the animal is indicated.

Figure 5. It shows three teats of increasing size (F, G, H) in lateral vision and the elevated strip (I) that corresponds to the fissure of the palate of the animal is indicated.

Figure 6. Represents an infant with palatal fissure feeding normally through the use of the teat of the invention.

Figure 7. It shows a cracked palate of a dog with a month of life that performed all the lactation with the teats object of the invention. The underlying nasal septum (B ') is appreciated. EMBODIMENT OF THE INVENTION

A Pachón Navarro dog with a full palatal fissure was used as an experimental model. During the four and a half weeks of lactation three teats of increasing size (F, G, H) were manufactured. In addition, during this period only 6 days of antibiotics had to be used to treat mild rhinitis.

To make the teat, first, a silicone impression of the palate was made, thus obtaining the negative thereof. Using plaster, the positive of the silicone printing was performed. Once the plaster is hardened, the plaster mold (A) represents the palate of the puppy (Fig. 1). Letter B of Figure 1 indicates the crack in the plaster mold.

Next (Fig. 2), from a standard bottle nipple (C), a solid silicone filling (D) was obtained, to which tip more silicone was added obtaining the filling (E), which was molded accordingly with the shape of the palate of the animal based on the plaster model (A) previously obtained (Fig. 3). With a thermo-vacuum machine (Easy Vac, Ultradent Products Inc., South Jordan, UT) and thermoformable plates of ethylene / vinyl acetate 1.5 mm thick (Mouthguard 060, Dentaflux, Madrid, Spain) the teat was obtained, of soft consistency, on the solid filler previously made of silicone and that has the shape of the animal's palate with the elevated strip (I) that corresponds to the cleft palate. The process was carried out by operating the machine, first in heat mode, until the plate had partially melted and was placed approximately one centimeter from the silicone mold made of the nipple. Immediately, the vacuum function of the machine was activated and the plate where the thermoformable plate was placed was lowered, so that it was perfectly adapted to the solid silicone filling with the shape of the animal's palate. This operation only took a few seconds so, once the solid silicone filling in accordance with the shape of the animal's palate was coated with the thermoformable iron, it was removed from the machine and placed under a tap of running water to cool it. Once cold, the teat was separated from the solid filler and the leftovers were cut from the plastic to achieve the final adaptation to a standard bottle. In this way, a nipple was obtained whose palatal face forms a dihedral angle with the truncated vertex. This vertex forms an elevated strip (I) that runs two thirds of the palatine face of the nipple starting from the tip, said elevated strip corresponding to the palatal fissure of the animal.

Three perforations with a 0.5 mm needle were made in the lingual area of the tip of the nipple to allow the milk to flow out. In this way, the infant, when performing the suction movements, covers the palatal fissure with the nipple whose elevated strip specifically obliterates the palatal fissure and the milk, which comes out of the lingual face, does not enter the nasal cavity. In the experimental model used, the process of obtaining the nipple was repeated three times during lactation, to adapt its shape and size to the real growth of the palate of the puppy. Figures 4 and 5 show the three successive teats (F, G, H) that were performed for the dog in which the method was tested, in palatine vision (Fig. 4) and in lateral vision (Fig. 5) and indicates in them the elevated strip (I) that corresponds to the fissure of the palate of the animal. Figure 6 shows the puppy of the experiment with three weeks of life sucking with the custom-made nipple of his palate. Figure 7 shows the palate of the puppy of the experiment at the month of life, where the presence of the palatal fissure and the underlying nasal septum (B ') can be seen, as well as a dentition corresponding to its age (six incisors, two canines and tips of the molars 2 and 3 ^o). With three months of life, the dog was in perfect health, its weight being comparable to that of its brothers in the same bait.

Claims

1. Individualized teat for infants with palatal fissure characterized in that the tip of said nipple is longer than the tip of a standard nipple so that, once introduced into the infant's mouth, it reaches the previous three quarters of the hard palate and the face palatal of said nipple forms a dihedral angle with the truncated vertex, vertex that forms an elevated strip (I) of irregular width and height located longitudinally along two thirds of said palatine face, said raised strip (I) being coupled to the fissure of the palate of the specific infant that you want to feed.

2. Teat according to claim 1 wherein the orifice or the exit orifices of the milk are made in the lingual surface of the teat.

3. Teat according to claim 2 in which three exit holes of the milk are made in the lingual surface of the teat.

4. Series of teats according to any of claims 1 to 3 that adapt to the growth of the oral cavity of the infant, said series comprising at least three teats whose size increases according to the increase in size of the oral cavity of the infant.

5. Teat according to any of claims 1 to 4 in which the infant is a human being.

6. Method for making an individualized nipple for infants with palatal fissure comprising:

a) obtaining a negative impression of the cracked palate in a dental impression material; b) use of the impression obtained in step a) to make a positive mold of the plaster cracked palate (A);

c) obtaining a solid filling of bottle nipple in a material for printing for dental use with the prolonged tip by adding more material for printing for dental use (E);

d) modeling the tip of the solid filling (E) adapting it to the mold (A) obtained in step b);

e) modeling of a thermoformable plate, by means of a thermo vacuum machine, using the one obtained in step d) as a mold.

7. Method according to claim 6 wherein a step f) is added in which between 1 and 3 holes are made in the lingual face of the nipple.

8. Method according to any of claims 6 or 7 in which a standard nipple is used to obtain the solid filling of step c).

9. Method according to any of claims 6 to 8 in which the material for printing for dental use is silicone.

10. A method according to any of claims 6 to 9 wherein the thermoformable material is ethylene / vinyl acetate.

11. Individualized teat for infants with palatal fissure obtainable by a method according to any of claims 6 to 10.