WO2011007027A1 - Tétine individualisée pour nouveaux-nés présentant une fissure palatine - Google Patents

Tétine individualisée pour nouveaux-nés présentant une fissure palatine Download PDF

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Publication number
WO2011007027A1
WO2011007027A1 PCT/ES2010/000308 ES2010000308W WO2011007027A1 WO 2011007027 A1 WO2011007027 A1 WO 2011007027A1 ES 2010000308 W ES2010000308 W ES 2010000308W WO 2011007027 A1 WO2011007027 A1 WO 2011007027A1
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WO
WIPO (PCT)
Prior art keywords
palate
nipple
teat
teats
fissure
Prior art date
Application number
PCT/ES2010/000308
Other languages
English (en)
Spanish (es)
Inventor
Concepción MARTÍNEZ ÁLVAREZ
Elena MARTÍNEZ SANZ
Inmaculada CASADO GÓMEZ
Concepción MARTÍN ÁLVARO
Original Assignee
Universidad Complutense De Madrid
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Universidad Complutense De Madrid filed Critical Universidad Complutense De Madrid
Publication of WO2011007027A1 publication Critical patent/WO2011007027A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J11/00—Teats
    • A61J11/007—Teats having orthodontic properties, e.g. for promoting correct teeth development
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J11/00—Teats
    • A61J11/0035—Teats having particular shape or structure

Definitions

  • 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.
  • 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.
  • 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.
  • patent US4632263A refers to a nipple incorporating a convex extension that occludes the cleft palate.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the material of choice can be introduced into a previously manufactured teat with a standard shape.
  • 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.
  • 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.
  • 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.
  • 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.
  • a single infant 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • a thermo-vacuum machine Esy Vac, Ultradent Products Inc., South Jordan, UT
  • 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.
  • 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.
  • FIG. 5 shows 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Dental Preparations (AREA)
  • Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)

Abstract

La présente invention concerne des tétines spécialement conçues pour des nouveaux-nés de n'importe quelle espèce présentant une fissure palatine. La pointe de ces tétines est plus longue que celle d'une tétine standard et la face palatine forme un angle dièdre dont le vertex est tronqué, formant ainsi une bande élevée qui s'accouple à la fissure du palais du nouveau-né, ce qui empêche le passage du lait dans les voies aériennes, évitant ainsi les pneumonies par aspiration et autres infections associées. L'invention concerne également le procédé de fabrication desdites tétines par l'obtention d'un moulage du palais fissuré et l'utilisation de plaques en plastique thermomoulable et d'une machine à vide thermique. Les tétines individualisées peuvent être utilisées dans l'alimentation de bébés et de petits aussi bien d'animaux de compagnie et de valeur économique spéciale que d'animaux d'expérimentation, permettant ainsi de créer un modèle d'expérimentation animale pour l'étude de cette pathologie si complexe.
PCT/ES2010/000308 2009-07-17 2010-07-16 Tétine individualisée pour nouveaux-nés présentant une fissure palatine WO2011007027A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES200901609A ES2352493B2 (es) 2009-07-17 2009-07-17 Tetina individualizada para lactantes con fisura palantina
ESP200901609 2009-07-17

Publications (1)

Publication Number Publication Date
WO2011007027A1 true WO2011007027A1 (fr) 2011-01-20

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Country Status (2)

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ES (1) ES2352493B2 (fr)
WO (1) WO2011007027A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES169785U (es) * 1971-06-09 1971-10-16 Diez Calvo M Luisa Tetina mejorada para bebes.
US4632263A (en) * 1985-01-30 1986-12-30 Gertzman Gloria B Nipple for a baby who has a cleft in its hard palate
US5072842A (en) * 1990-10-15 1991-12-17 White Ray D Artificial nipple construction

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES169785U (es) * 1971-06-09 1971-10-16 Diez Calvo M Luisa Tetina mejorada para bebes.
US4632263A (en) * 1985-01-30 1986-12-30 Gertzman Gloria B Nipple for a baby who has a cleft in its hard palate
US5072842A (en) * 1990-10-15 1991-12-17 White Ray D Artificial nipple construction

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Publication number Publication date
ES2352493B2 (es) 2012-08-02
ES2352493A1 (es) 2011-02-21

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