ES2352493B2 - INDIVIDUALIZED TETINA FOR INFANT WITH PALANTINE FISURE - Google Patents

Abstract

The present invention relates to teats specially designed for infants of any species with palatal fissure. The tip of these teats is longer than that of a standard nipple and the palatal face forms a dihedral angle whose vertex is truncated forming an elevated strip that attaches to the fissure of the infant's palate preventing the passage of milk into the airway, thus avoiding aspiration pneumonia and other associated infections. The invention also relates to the method of making these teats by obtaining a mold of the cracked palate and the use of thermoformable plastic sheets and a thermo vacuum machine. The individualized teats can be used in the feeding of babies and offspring of both companion animals and of special economic value as well as experimental animals, allowing to create an animal experimentation model for the study of this complex pathology.

Description

So far, to feed children with confidence

Individualized teat for infants with palatine fats. Technical sector

The invention falls within the sector of the manufacture of teats for infant feeding. More specifically, it refers to teats for feeding infants with palatal friars, 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 fats, adapt to the malformation in each particular case, effectively prevent the passage of milk into the airway and thus prevent aspiration pneumonia and minimize other respiratory infections. State of the art

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 value 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 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, depending on the severity of the defect, different feeding techniques based primarily on infant posture (Kasten EF, Schmidt SP, Zickler CF, Berner E, Damian 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 a lot of sacrifice and attention from breeders to take the puppies forward (Kemp C, Thiele H, 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 The standard teats are used either as standard teats or standardized special teats for furs, wider and flattened than normal teats, which means that rhinitis and otitis media are very frequent, since the milk penetrates very easily into the nasal cavity, requiring administration of antibiotics persistently.

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

The NÜK company sells a special nipple for a fi nal palatine that covers the fi lm and is sold without an outlet (ES207949T3) and Medela also markets a nipple specially indicated for children with a palatine flush, Down syndrome or other neurological disorders.

In other mammals, the animal is frequently 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 a veterinary clinic, if you want to save the puppy's life with palatal fury, 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, tailored for each individual, animal or human, allows high safety against the risk of aspiration during lactation of the fused, as it adapts individually obliterating the communication defect and allows the milk to pass directly To the pharynx. This represents a very important advance in three aspects. In the case of infants, 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 repair surgery of the defect. Finally, the development of this new feeding technique will allow the start-up and standardization of the care of large animal models for the study of the palatine fissure where it is possible 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 infants or the fierce is created surgically (usually in dogs) and then repaired, which generates a new confounding factor and makes interpretation and viability difficult. results derived from the studies. In this sense, a natural model of animal fused and fed in a simple way will be a great advantage. It must be said that the actual surgical closure of the palatine fissure still carries 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 adulthood, 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 refers to an individualized bottle nipple tailored to feed infants with palatal fury, including man, without risk of pulmonary aspiration and minimizing the onset 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 the totality of the infant's palate, when sucking it and pressing the teat with the tongue to obtain the liquid, the fi lter 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 breastfeeding tool can be used in any mammal that presents palatine fats of any type, being more interesting for those with complete confidence, 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 the modifications with respect to a standard nipple are made on the palatal face and on the tip of the nipple while the bottle binding end can be exactly same as a standard nipple.

In the present invention, "palatal face" of the nipple means the surface of the nipple that is in contact with the infant's palate when the nipple is inserted into its mouth. Similarly, in this invention, the "lingual face" of the nipple is the surface of the nipple that is in contact with the infant's tongue when the nipple is inserted into the mouth of the nipple. The term "tip" of the nipple, in the present invention, refers to the end of the nipple opposite the end by which it is attached to 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 of the same in plaster, so that a plaster mold is generated which is the positive one of the fused palate. Preferably “stone” plaster 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. Subsequently, more silicone is added to the tip of this solid filler 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 fused palate, so that the solid filler has a raised stripe that corresponds to the flabby of the infant's palate. Using a thermo-vacuum machine, the teats made of thermo-moldable plastic of fl exible 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 nipple forms a dihedral angle whose vertex is truncated, a vertex that attaches to the flab of the specific infant's palate that it is desired to feed. This truncated vertex forms an elevated strip on the palatine surface of the nipple and, being located longitudinally along two thirds of the palatine face of the nipple from the tip, reproduces the fissure of the palate, so that its width and Their height is irregular and of millimeter dimensions in the teats made for small-sized animal species, while in species such as human and larger they reach dimensions of up to 2-4 cm.

When manufactured specifically for a particular 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 flate of the 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 fi gures

Figure 1. Represents the palate mold (A) of a dog with plaster-shaped palatine 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 flate of the animal's palate 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 flate of the palate of the animal is indicated.

Figure 6. Represents an infant with a palatal palat feeding normally by using the nipple of the invention.

Figure 7. It shows a dog's palate 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

An experimental Pachón Navarro dog with complete palatal fury 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 nipple, first, a silicone impression of the palate was made, thus obtaining its negative. Using plaster, the positive silicone printing was performed. Once the plaster has hardened, the plaster mold (A) represents the puppy's palate (Fig. 1). Letter B in Figure 1 indicates the fi gure 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, Denta fl ux, Madrid, Spain) the nipple was obtained, of soft consistency, on the solid filler previously made of silicone and which has the shape of the animal's palate with the raised stripe (I) that corresponds to the flate of the palate. The process was carried out by operating the machine, first in heat mode, until the iron 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 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 filling 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 fats of the animal.

Three perforations with a 0.5 mm gauge 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 flabby palatine with the nipple whose raised strip specifically obliterates the flabby palatine 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 breastfeeding, to adapt its shape and size to the real growth of the puppy's palate. 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 it indicates in them the elevated strip (I) that corresponds to the flate of the animal's palate. 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 palatine fissure and the underlying nasal septum (B ') can be seen, as well as a dentition corresponding to its age (six incisors, two canines and Temporary molar tips 2nd and 3rd). With three months of life the dog was in perfect state of health, its weight being comparable to that of its brothers in the same bait.

Claims (12)

1. Individualized teat for infants with a palatine profile characterized in that the tip of said nipple is longer than the tip of a standard nipple so that, once inserted into the infant's mouth, it reaches the anterior three quarters of the hard palate and 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 engaging (I) to the flate of the palate of the specific infant to be fed.

2.

Teat according to claim 1 in which the orifice or the exit holes of the milk are made on the lingual surface of the nipple.

3.

Teat according to claim 2 in which three milk outlets are made on the lingual surface of the nipple.

Four.

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 because the infant is a human being.

6.

Method for making an individualized nipple for infants with palatal flush, according to claims 1-5, comprising:

a) obtaining a negative impression of the palate fi ed on a material for printing for dental use; b) use of the impression obtained in step a) to make a positive mold of the palate fi riated in plaster (A); c) obtaining a solid filling of bottle nipple in a dental impression material with the prolonged tip by adding more impression material 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.

Method according to any one of claims 6 to 9 where the thermoformable material is ethylene / vinyl acetate.

eleven.

Individualized teat for infants with palatine fi rm obtainable by a method according to any of claims 6 to 10.

SPANISH PATENTS AND BRANDS OFFICE Application no .: 200901609 SPAIN Date of submission of the application: 07.17.2009

REPORT ON THE STATE OF THE TECHNIQUE

Priority Date:    

51 Int. Cl.:

A61J 11/00 (2006.01)

 RELEVANT DOCUMENTS  

Category

56 Documents cited Claims Affected

A A A

US 4632263 A (GERTZMAN) 30.12.1986, the whole document. US 5072842 A (WHITE) 17.12.1991, the entire document. EN 169785 U (MARIA LUISA DIEZ CALVO) 09.12.1972, the whole document. 1.4 1 1

Category of the documents cited X: of particular relevance Y: of particular relevance combined with other / s of the same category A: reflects the state of the art O: refers to unwritten disclosure P: published between the priority date and the date of priority submission of the application E: previous document, but published after the date of submission of the application

This report has been prepared • for all claims • for claims no:

Date of realization of the report 06.17.2010

Examiner A. Amaro Roldán Page 1/4

Application number: 200901609 REPORT ON THE STATE OF THE TECHNIQUE Minimum documentation sought (classification system followed by classification symbols) A61J Electronic databases consulted during the search (name of the database and, if possible, search terms used) INVENES, EPODOC, WPI, NPL, EMBASE State of the Art Report (additional sheet) Page 2/4  WRITTEN OPINION Application number: 200901609 Date of Completion of Written Opinion: 06.17.2010

Statement

Novelty (Art. 6.1 LP 11/1986)

Claims 1-11 Claims _____________________________________ IF NOT

Inventive activity

Claims 1-11 YES

(Art. 8.1 LP11 / 1986)

Claims _____________________________________ NO

The application is considered to comply with the industrial application requirement. This requirement was evaluated during the formal and technical examination phase of the application (Article 31.2 Law 11/1986).  Opinion Base.- This opinion has been made on the basis of the patent application as published.  Considerations: The present invention relates to an individualized nipple for infants with palatal fissure, both human and animal. The tip of these teats is longer than that of a traditional nipple and the palatal face forms a dihedral angle whose vertex is truncated forming an elevated strip that attaches to the fissure of the infant's palate preventing the passage of milk into the airway . The invention also relates to the method for making said teats by obtaining a mold of the cracked palate and the use of thermoformable plastic sheets and a thermo vacuum machine (Figure 3). The exit holes are made in the lingual surface of the nipple. A series of teats can be made whose size increases as the infant's oral cavity increases (Figure 4). Report on the State of the Art (Written Opinion) Page 3/4  WRITTEN OPINION Application number: 200901609 1. Documents considered.- The documents belonging to the state of the art taken into consideration for the realization of this opinion are listed below.

Document

Publication or Identification Number publication date

D01

US 4632263 A 12-30-1998

D02

US 5072842 A 17.12.1991

D03

ES 169785 U 09.12.1972

2. Statement motivated according to articles 29.6 and 29.7 of the Regulations for the execution of Law 11/1986, of March 20, on Patents on novelty and inventive activity; quotes and explanations in support of this statement D01 refers to a nipple comprising a hollow flexible tube. At one end the tube is attached to the bottle of the bottle and at the other end it incorporates a convex extension that occludes the cleft palate (Figure 1). Claim 3 includes a series of teats adapted to accommodate the growth of the baby's mouth, comprising at least four teats with extensions that are gradually larger. D02 refers to an artificial nipple and its manufacture, in which the nipple includes concave hyperbolic lateral surfaces directed upward between a first and second tip, with a U-shaped fissure located in the middle between the first and second tip (Figures 1 and 8). D03 refers to a nipple for babies, characterized by the fact that the nipple is perforated by two or more lateral holes whose axes are located in a medium plan of the nipple and form an angle of about 80º, of such that divergent jets are formed that oppose the direct entry of the liquid into the creature's throat (Figure 1). NEW AND INVENTIVE ACTIVITY The documents cited only show the general state of the art and are not considered of particular relevance, since for a person skilled in the art, it would not be obvious to apply the characteristics of the cited documents and arrive at the invention as mentioned in claims 1-11. Therefore, the purpose of this application meets the requirements of novelty and inventive activity in accordance with Articles 6 and 8 of Patent Law 11/1986. Report on the State of the Art (Written Opinion) Page 4/4