WO2023017297A1 - Method for forming cosmetic and reconstructive facial implants from a cork-based material and material thus constituted - Google Patents

Method for forming cosmetic and reconstructive facial implants from a cork-based material and material thus constituted Download PDF

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Publication number
WO2023017297A1
WO2023017297A1 PCT/IB2021/057424 IB2021057424W WO2023017297A1 WO 2023017297 A1 WO2023017297 A1 WO 2023017297A1 IB 2021057424 W IB2021057424 W IB 2021057424W WO 2023017297 A1 WO2023017297 A1 WO 2023017297A1
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Prior art keywords
cork
proportion
reconstructive
cosmetic
silicone
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PCT/IB2021/057424
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Spanish (es)
French (fr)
Inventor
Adolfo ROSALES MALDONADO
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Rosales Maldonado Adolfo
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Priority to PCT/IB2021/057424 priority Critical patent/WO2023017297A1/en
Publication of WO2023017297A1 publication Critical patent/WO2023017297A1/en
Priority to CONC2023/0002040A priority patent/CO2023002040A2/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B27—WORKING OR PRESERVING WOOD OR SIMILAR MATERIAL; NAILING OR STAPLING MACHINES IN GENERAL
    • B27K—PROCESSES, APPARATUS OR SELECTION OF SUBSTANCES FOR IMPREGNATING, STAINING, DYEING, BLEACHING OF WOOD OR SIMILAR MATERIALS, OR TREATING OF WOOD OR SIMILAR MATERIALS WITH PERMEANT LIQUIDS, NOT OTHERWISE PROVIDED FOR; CHEMICAL OR PHYSICAL TREATMENT OF CORK, CANE, REED, STRAW OR SIMILAR MATERIALS
    • B27K7/00—Chemical or physical treatment of cork

Definitions

  • This invention relates to a process for shaping cosmetic and reconstructive facial implants that includes preliminary stages of firing and laminating the cork, where the process also comprises; granulation of the obtained cork material; mixing the granulated material with an emulsion based on the mixture of cork, polyurethane, silicone and a solvent such as xylene; one pressing step; air injection baking; and, drying of the material and shaping and molding of the implant in addition to a sterilization bath in ethylene oxide.
  • the shaping material for cosmetic and reconstructive facial implants is made from a composition of cork in combination with polyurethane and silicone.
  • the present invention is applicable in the art of facial implants to correct a bone defect, such as face surgery for rhinoplasty, mentoplasty, pomuloplasty and malar surgery.
  • This surgical indication comes within the field of reconstructive and cosmetic plastic surgery.
  • the results are permanent and its structure should not fade over time. BACKGROUND OF THE INVENTION.
  • Polypropylene has a higher melting point (150-173°C), higher tensile strength, and greater stiffness than polyethylene. It is also less permeable than polyethylene to liquids and gases. However, even though polypropylene has acceptable biocompatibility, the art has sought new materials that are lighter and more compatible with human tissue.
  • a first object of the present invention is to avoid the drawbacks of the prior art. More particularly, an object of the present invention is to create a process for shaping facial, cosmetic and reconstructive implants from a cork-based material.
  • the objective of the present invention is to provide a material of natural origin that, due to its chemical composition, allows certain properties that make it a unique material.
  • the present invention meets these needs and provides other related advantages.
  • This invention relates generally to a process for forming cosmetic and reconstructive facial implants from a cork-based material.
  • Cork is a material that cannot be easily studied and has not yet been accurately replicated artificially.
  • the cork has a composition based on table 1.
  • implants are formed in face surgery such as rhinoplasty, mentoplasty, pomuloplasty, malar surgery or in any surgery to correct a bone defect.
  • the cork material is extracted directly from the cork oak to avoid contamination and thus obtain a material without impurities to later be sterilized and used in the composition object of the present invention as an implant.
  • the cork will be stabilized for a minimum of six months, until reaching uniform humidity. Each consignment is labeled and recorded so that it is possible to know the origin of each individual lot. Traceability is very important to obtain Forest Stewardship Council (FSC) certification.
  • FSC Forest Stewardship Council
  • the next step is cooking.
  • the objective is to eliminate the organic solids lodged in the pores, and allow the cork to reach the correct humidity to be processed.
  • CONVEX® The special system implemented by Amorim, called CONVEX®, also captures and removes volatile organic compounds from the cooking water.
  • Each batch is cooked for one hour in a high-tech treatment tank. When leaving, the plates have increased their volume by almost 20% and are more regular and easier to manipulate.
  • the plates After firing, the plates are too wet to be processed, so they must rest stacked and stabilized in a sterile area with good ventilation for at least days to be processed.
  • the ends are prepared by smoothing the edges and forming sheets.
  • the sheets are classified by categories based on their appearance, thickness and porosity.
  • the implant composition manufacturing process comprises:
  • the emulsion of the second step (ii) is made with different dilutions according to the use that is going to be given to the cork and once it has reacted it makes it completely inert and irreversible.
  • xylene, xylene or dimethylbenzene is a dimethylated derivative of benzene and is an effective solvent for the treatment of the material.
  • a composition is formed that includes cork in combination with polyurethane and silicone.
  • Polyurethane is a polymer obtained from hydroxyl bases combined with diisocyanates.
  • Silicone is an inorganic polymer derived from polysiloxane. The addition amount of the xylol solvent is in a proportion of the mass of material at 2.96%.
  • the shaping material for cosmetic and reconstructive facial implants made with the process comprises a cork composition in a proportion of between 70% and 90%, preferably 85.5% in combination with polyurethane in a proportion between 5 and 9%, preferably 7.69% and silicone in a proportion between 2 and 5%, preferably 3.85%.
  • the chemical composition of the material made from the present invention comprises:
  • the material comprises a density and lightness less than silicone, avoiding bone resorption.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • Forests & Forestry (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention relates to a method for forming cosmetic and reconstructive facial implants, which includes preliminary steps of cooking and laminating cork. The method also comprises: carrying out a sterilisation bath in ethylene oxide; granulating the sterile cork material obtained; mixing the granulated material with an emulsion based on cork, polyurethane, silicone and xylol; a step of pressing; baking with injected air; and drying the material, and forming and moulding the implant. The material for forming cosmetic and reconstructive facial implants is produced from a composition of cork combined with polyurethane and silicone. The present invention can be used in the technique of facial implants to correct a bone defect, such as facial surgery for rhinoplasty, mentoplasty, cheekbone surgery and malar surgery. This surgical indication falls within the field of reconstructive and cosmetic plastic surgery. The results are permanent and the structure should not vary over time.

Description

PROCESO DE CONFORMACION DE IMPLANTES FACIALES COSMÉTICOS Y RECONSTRUCTIVOS A PARTIR DE UN MATERIAL BASADO EN CORCHO Y EL MATERIAL ASÍ CONSTITUIDO
Figure imgf000002_0001
PROCESS OF FORMATION OF COSMETIC AND RECONSTRUCTIVE FACIAL IMPLANTS FROM A CORK-BASED MATERIAL AND THE MATERIAL SO CONSTITUATED
Figure imgf000002_0001
CAMPO DE LA INVENCIÓN. FIELD OF THE INVENTION.
Esta invención relaciona con un proceso de conformación de implantes faciales cosméticos y reconstructivos que incluye etapas preliminares de cocción y laminado del corcho, donde el proceso además comprende; granulación del material de corcho obtenido; mezclado del material granulado con una emulsión basada a partir de la mezcla de corcho, poliuretano, silicona y un disolvente tal como xilol; un paso de prensado; horneado con inyección de aire; y, secado del material y conformación y moldeado del implante además de un baño de esterilización en óxido de etileno. This invention relates to a process for shaping cosmetic and reconstructive facial implants that includes preliminary stages of firing and laminating the cork, where the process also comprises; granulation of the obtained cork material; mixing the granulated material with an emulsion based on the mixture of cork, polyurethane, silicone and a solvent such as xylene; one pressing step; air injection baking; and, drying of the material and shaping and molding of the implant in addition to a sterilization bath in ethylene oxide.
El material de conformación de implantes faciales cosméticos y reconstructivos está elaborado a partir de una composición de corcho en combinación con poliuretano y silicona. The shaping material for cosmetic and reconstructive facial implants is made from a composition of cork in combination with polyurethane and silicone.
La presente invención es aplicable en la técnica de los implantes faciales para corregir un defecto óseo, tales como cirugía de cara para rinoplastias, mentoplastias, pomuloplastia y cirugía de malar. Esta indicación quirúrgica viene dentro del campo de cirugía reconstructiva y plástica cosmética. Los resultados son permanentes y su estructura no debe vahar con el tiempo. ANTECEDENTES DE LA INVENCION. The present invention is applicable in the art of facial implants to correct a bone defect, such as face surgery for rhinoplasty, mentoplasty, pomuloplasty and malar surgery. This surgical indication comes within the field of reconstructive and cosmetic plastic surgery. The results are permanent and its structure should not fade over time. BACKGROUND OF THE INVENTION.
Para cirugías estéticas y reconstructivas se han usado diversos materiales aloplásticos biocompatibles algunos como, Gorotex, Medpore (polietileno de alta densidad) y algunos materiales inyectables como colágeno, hidroxiapatita, polimetilmetacrilato y ácido hialurónico que se han desarrollado para ser usados en procedimientos quirúrgicos y no quirúrgicos desde 1930. Tienen la ventaja de menor morbilidad, acortar tiempos de reconstrucción por encontrarse en cantidades ilimitadas, con propiedades específicamente diseñadas. Dentro de sus desventajas se encuentra el riesgo de incompatibilidad, incluso años después de la cirugía, riesgo de infección, migración, extrusión y la posibilidad de cambios en sus propiedades físicas luego de su colocación. No existen estudios en humanos que muestren malignización inducida en resultado de implantes a la fecha. La utilización de estos biomateriales continúa siendo materia de debate y controversia, habiéndose introducido en plástica nasal. For aesthetic and reconstructive surgeries, various biocompatible alloplastic materials have been used, such as Gorotex, Medpore (high-density polyethylene) and some injectable materials such as collagen, hydroxyapatite, polymethylmethacrylate and hyaluronic acid that have been developed for use in surgical and non-surgical procedures. since 1930. They have the advantage of lower morbidity, shorten reconstruction times because they are in unlimited quantities, with specifically designed properties. Among its disadvantages is the risk of incompatibility, even years after surgery, risk of infection, migration, extrusion, and the possibility of changes in its physical properties after placement. There are no human studies showing induced malignancy as a result of implants to date. The use of these biomaterials continues to be a matter of debate and controversy, having been introduced in nasal plastics.
El estado de la técnica ha revelado algunos desarrollos como el pretendido en la patente de Estados Unidos, US20060217813 de Posnick, revela implantes faciales cosméticos y reconstructivos fabricados a partir de polietileno lineal de baja densidad. Los implantes de polietileno pueden ser porosos para permitir el crecimiento de tejido. Las formas de los implantes se pueden fabricar en una variedad de formas y volúmenes para aumentar o restaurar el contorno del esqueleto cráneo-maxilofacial y para reemplazar un volumen de tejido blando deficiente (por ejemplo, globo ocular). Si bien el polietileno ha demostrado ser un plástico versátil y útil, sus propiedades no son ideales para todas las aplicaciones. Por esta razón, los químicos han investigado la polimerización de otros monomeros olefinicos, particularmente monomeros que poseen un grupo sustituyente distinto al hidrógeno en uno de los átomos de carbono olefinicos. Los polímeros que resultan de estas reacciones poseen propiedades físicas diferentes a las del polietileno y han encontrado importantes aplicaciones. El polipropileno tiene un punto de fusión más alto (150-173 °C), mayor resistencia a la tracción y mayor rigidez que el polietileno. También es menos permeable que el polietileno a líquidos y gases. No obstante, aun cuando el polipropileno comprende una biocompatibilidad aceptable, el arte ha buscado nuevos materiales que sean más livianos y compatibles con el tejido humano. The state of the art has revealed some developments such as the one claimed in the United States patent, US20060217813 by Posnick, which reveals cosmetic and reconstructive facial implants made from linear low-density polyethylene. Polyethylene implants can be porous to allow for tissue growth. Implant shapes can be fabricated in a variety of shapes and volumes to augment or restore the contour of the craniomaxillofacial skeleton and to replace deficient soft tissue volume (eg, eyeball). While polyethylene has proven to be a versatile and useful plastic, its properties are not ideal for all applications. For this reason, chemists have investigated the polymerization of other olefinic monomers, particularly monomers having a non-hydrogen substituent group on one of the olefinic carbon atoms. The polymers resulting from these reactions have physical properties different from those of polyethylene and have found important applications. Polypropylene has a higher melting point (150-173°C), higher tensile strength, and greater stiffness than polyethylene. It is also less permeable than polyethylene to liquids and gases. However, even though polypropylene has acceptable biocompatibility, the art has sought new materials that are lighter and more compatible with human tissue.
Por tanto, la búsqueda de materiales eficaces para la construcción de implantes siempre ha estado presente en la técnica. Therefore, the search for effective materials for the construction of implants has always been present in the art.
OBJETO DE LA INVENCIÓN. OBJECT OF THE INVENTION.
Por consiguiente, un primer objeto de la presente invención es evitar las desventajas del arte previo. Más particularmente, un objeto de la presente invención es el crear un proceso de conformación de implantes faciales, cosméticos y reconstructivos a partir en un material basado en corcho. Therefore, a first object of the present invention is to avoid the drawbacks of the prior art. More particularly, an object of the present invention is to create a process for shaping facial, cosmetic and reconstructive implants from a cork-based material.
El objetivo de la presente invención es proporcionar un material de origen natural que por su composición química, le permite ciertas propiedades que lo hacen un material único. The objective of the present invention is to provide a material of natural origin that, due to its chemical composition, allows certain properties that make it a unique material.
Un objeto no menos importante del arreglo de un proceso para conformar un material para un implante que garantice su inmovilidad y se fije de manera eficaz. A no less important object of the arrangement of a process to form a material for an implant that guarantees its immobility and is fixed effectively.
Adicionalmente otro objeto importante, existe en la necesidad de crear un material para implantes con características eficaces para evitar reacciones no deseadas, como la reabsorción de tejido debido a la presión. In addition to another important object, there is a need to create a material for implants with effective characteristics to avoid unwanted reactions, such as tissue resorption due to pressure.
La presente invención cumple estas necesidades y proporciona otras ventajas relacionadas. The present invention meets these needs and provides other related advantages.
Las características novedosas que se consideran como fundamento de la invención son expuestas en particular en las reivindicaciones adjuntas y las ventajas adicionales del mismo, se entenderán mejor sobre la descripción detallada siguiente con las modalidades preferidas. The novel features which are considered to be the basis of the invention are set forth in particular in the appended claims and the additional advantages thereof, will be better understood from the following detailed description with the preferred embodiments.
DESCRIPCIÓN DETALLADA DE LA INVENCIÓN DETAILED DESCRIPTION OF THE INVENTION
Esta invención se relaciona generalmente con un proceso de conformación de implantes faciales cosméticos y reconstructivos a partir en un material basado en corcho. This invention relates generally to a process for forming cosmetic and reconstructive facial implants from a cork-based material.
Las características del corcho hicieron pensar a los inventores como una alternativa de material eficaz para implantes faciales cosméticos y reconstructivos. Cork's characteristics led the inventors to think of it as an effective material alternative for cosmetic and reconstructive facial implants.
El corcho es un material que no se deja estudiar fácilmente y aun no se ha podido replicar artificialmente con exactitud. Cork is a material that cannot be easily studied and has not yet been accurately replicated artificially.
El corcho tienen una composición con base en la tabla 1. The cork has a composition based on table 1.
A partir del proceso de la invención, se conforman implantes en cirugía de cara tales como rinoplastias, mentoplastias, pomuloplastia, cirugía de malar o en cualquier cirugía para corregir un defecto óseo.
Figure imgf000006_0001
From the process of the invention, implants are formed in face surgery such as rhinoplasty, mentoplasty, pomuloplasty, malar surgery or in any surgery to correct a bone defect.
Figure imgf000006_0001
Tabla :L Composición del corcho Table :L Composition of cork
Según el proceso de la invención, el material de corcho se extrae directamente del alcornoque para evitar contaminación y así obtener un material sin impurezas para luego ser esterilizado y usado en la composición objeto de la presente invención como implante. According to the process of the invention, the cork material is extracted directly from the cork oak to avoid contamination and thus obtain a material without impurities to later be sterilized and used in the composition object of the present invention as an implant.
Para la invención, el corcho se estabilizará durante un mínimo de seis meses, hasta alcanzar una humedad uniforme. Cada remesa se etiqueta y registra para que sea posible conocer el origen de cada lote individual. La trazabilidad es muy importante para obtener la certificación del Forest Stewardship Council (FSC). Las planchas de corcho se apilan sobre estructuras de acero inoxidable en grandes superficies cementadas construidas en un plano ligeramente inclinado, para evitar la contaminación microbiana y maximizar la circulación del aire. For the invention, the cork will be stabilized for a minimum of six months, until reaching uniform humidity. Each consignment is labeled and recorded so that it is possible to know the origin of each individual lot. Traceability is very important to obtain Forest Stewardship Council (FSC) certification. The cork sheets are stacked on stainless steel structures on large cemented surfaces built on a slightly inclined plane, to avoid microbial contamination and maximize air circulation.
Tras el periodo de reposo, las planchas son clasificadas. After the rest period, the plates are classified.
El siguiente paso es la cocción. El objetivo es eliminar los sólidos orgánicos alojados en los poros, y permitir que el corcho alcance la humedad correcta para ser procesado. El sistema especial implementado por Amorim, denominado CONVEX®, también captura y elimina los compuestos orgánicos volátiles del agua de cocción. Cada lote se cuece durante una hora en un tanque de tratamiento de alta tecnología. Al salir, las planchas han aumentado casi un 20% su volumen y son más regulares y fáciles de manipular. The next step is cooking. The objective is to eliminate the organic solids lodged in the pores, and allow the cork to reach the correct humidity to be processed. The special system implemented by Amorim, called CONVEX®, also captures and removes volatile organic compounds from the cooking water. Each batch is cooked for one hour in a high-tech treatment tank. When leaving, the plates have increased their volume by almost 20% and are more regular and easier to manipulate.
Tras la cocción, las planchas están demasiado húmedas para ser procesadas, por lo que deben reposar apiladas y estabilizadas en una zona estéril y con buena ventilación durante por lo menos días para ser procesadas. After firing, the plates are too wet to be processed, so they must rest stacked and stabilized in a sterile area with good ventilation for at least days to be processed.
Una vez comprende la humedad necesaria, se preparan los extremos alisando los cantos y conformando láminas. Las láminas se clasifican por categorías en función de su aspecto, grosor y porosidad. Once it includes the necessary humidity, the ends are prepared by smoothing the edges and forming sheets. The sheets are classified by categories based on their appearance, thickness and porosity.
Luego del proceso de cocción y laminado del corcho, el proceso de fabricación de la composición de los implantes comprende: After the cork firing and laminating process, the implant composition manufacturing process comprises:
(i) un primer paso de granulación del material corcho; (i) a first step of granulating the cork material;
(¡i) un segundo paso de mezclado del material corcho en una proporción de 1000gr con 90gr de poliuretano y 45gr de silicona, mezclado con un disolvente tal como xilol en una proporción de 400ml hasta obtener una emulsión; (ii) a second step of mixing the cork material in a proportion of 1000gr with 90gr of polyurethane and 45gr of silicone, mixed with a solvent such as xylol in a proportion of 400ml until an emulsion is obtained;
(iii) un tercer paso de prensado de la masa obtenida de entre 150 a 220 T/m2 para la obtención del material con una densidad de 360 kg/m3; (iii) a third step of pressing the mass obtained between 150 and 220 T/m 2 to obtain the material with a density of 360 kg/m 3 ;
(iv) un cuarto paso de horneado por un término de 6 a 8 horas a un temperatura de entre 180 y 240°C con inyección de aire de hasta 4,531 m3/min (160 fP/min); (iv) a fourth baking step for a period of 6 to 8 hours at a temperature between 180 and 240°C with air injection of up to 4,531 m 3 /min (160 fP/min);
(v) un quinto paso de secado del material, seguido de la conformación y moldeado del implante; y, (vi) un sexto paso donde el implante moldeado pasa por un baño de esterilización en oxido de etileno para eliminar cualquier microorganismo. (v) a fifth step of drying the material, followed by the shaping and molding of the implant; and, (vi) a sixth step where the molded implant passes through a sterilization bath in ethylene oxide to eliminate any microorganisms.
Una vez se ha elaborado el paso sexto (vi) de esterilización se comprueba la presencia o trazas de oxido de etileno en el material estéril para poderle dar uso. Once the sixth step (vi) of sterilization has been carried out, the presence or traces of ethylene oxide in the sterile material is checked so that it can be used.
Según la invención, la emulsión del segundo paso (¡i) se hace con diferentes diluciones de acuerdo al uso que se le vaya a dar al corcho y una vez haya reaccionado lo hace completamente inerte e irreversible. According to the invention, the emulsion of the second step (ii) is made with different dilutions according to the use that is going to be given to the cork and once it has reacted it makes it completely inert and irreversible.
Para la conformación de la emulsión, el xileno, xilol o dimetilbenceno, C6H4(CH3)2 es un derivado dimetilado del benceno y es un disolvente eficaz para el tratamiento del material. A partir de dicho disolvente, se conforma una composición que incluye corcho en combinación con poliuretano y silicona. El poliuretano es un polímero que se obtiene de bases hidroxílicas combinadas con diisocianatos. La silicona es un polímero inorgánico derivado del polisiloxano. La cantidad de adición del disolvente xilol está en una proporción de la masa de material en el 2,96%. For the formation of the emulsion, xylene, xylene or dimethylbenzene, C 6 H 4 (CH 3 ) 2 is a dimethylated derivative of benzene and is an effective solvent for the treatment of the material. From said solvent, a composition is formed that includes cork in combination with polyurethane and silicone. Polyurethane is a polymer obtained from hydroxyl bases combined with diisocyanates. Silicone is an inorganic polymer derived from polysiloxane. The addition amount of the xylol solvent is in a proportion of the mass of material at 2.96%.
Particularmente según la presente invención, el material de conformación de implantes faciales cosméticos y reconstructivos elaborado con el proceso, comprende una composición de corcho en una proporción de entre 70% y 90%, preferiblemente de 85,5% en combinación con poliuretano en una proporción de entre 5 y 9%, preferiblemente de 7,69% y silicona en una proporción de entre 2 y 5%, preferiblemente de 3,85%. Particularly according to the present invention, the shaping material for cosmetic and reconstructive facial implants made with the process comprises a cork composition in a proportion of between 70% and 90%, preferably 85.5% in combination with polyurethane in a proportion between 5 and 9%, preferably 7.69% and silicone in a proportion between 2 and 5%, preferably 3.85%.
Una vez conformado el implante de material con base en corcho, silicona y poliuretano, es posible su uso como implantes óptimos para las reconstrucciones nasales y faciales. La composición química del material elaborado a partir de la presente invención comprende: Once the cork, silicone and polyurethane-based material implant is formed, it is possible to use it as optimal implants for nasal and facial reconstructions. The chemical composition of the material made from the present invention comprises:
-baja densidad y ligereza donde las células del material comprenden un 90% ocupado por aire; -low density and lightness where the cells of the material comprise 90% occupied by air;
-impermeabilidad, donde la suberina y ceras presentes en la pared celular hacen que sea prácticamente impermeable a líquidos y gases de manera que los poros en forma hexagonal de su pared están llenos de aire inaccesible a otros compuestos; -impermeability, where the suberin and waxes present in the cell wall make it practically impermeable to liquids and gases so that the hexagonal-shaped pores of its wall are filled with air inaccessible to other compounds;
-baja transmisión de calor y buen aislante térmico basado en el elevado contenido de gas, el tamaño de las células y el bajo poder de adsorción; -low heat transmission and good thermal insulation based on the high gas content, the size of the cells and the low adsorption power;
-aislante acústico y baja transmisión del sonido donde la baja densidad y elevada porosidad hacen que las ondas del sonido adsorben y se transformen en energía calorífica; -Acoustic insulation and low sound transmission where the low density and high porosity cause sound waves to be absorbed and transformed into heat energy;
-elevada resistencia al movimiento o elevado coeficiente de fricción donde el efecto de ventosa provoca que la superficie de las células mejore la adherencia a superficies; -high resistance to movement or high coefficient of friction where the suction cup effect causes the surface of the cells to improve adherence to surfaces;
-capacidad de amortiguación ofrecida por la deformación por flexión de las paredes celulares; - damping capacity offered by the bending deformation of the cell walls;
-compresibilidad, elasticidad y flexibilidad; -compressibility, elasticity and flexibility;
-durabilidad, estabilidad y rigidez con base en la lignina y taninos donde los polisacáhdos de su pared celular le proporcionan rigidez y lo hacen resistente al paso del tiempo; e, -durability, stability and rigidity based on lignin and tannins where the polysaccharides of its cell wall provide rigidity and make it resistant to the passage of time; and,
-higroscópico, de manera que hidrata en función de las condiciones ambientales; Algunas de sus propiedades físicas y mecánicas son debidas a las características estructurales a nivel celular y la estructura química de la pared vegetal que incluye una densidad de 120 a 200kg m3. -hygroscopic, so that it hydrates depending on the environmental conditions; Some of its physical and mechanical properties are due to the structural characteristics at the cellular level and the chemical structure of the plant wall, which includes a density of 120 to 200 kg m 3 .
Según la composición de la invención, el material comprende una densidad y ligereza menor a la silicona evitando la reabsorción ósea. According to the composition of the invention, the material comprises a density and lightness less than silicone, avoiding bone resorption.
EJEMPLO 1. EXAMPLE 1.
A partir del material conformado mediante el proceso de la presente invención, se ha implantado en la apófisis mastoide de un paciente sin rechazo alguno, más allá de una ligera inflamación normal presentada durante su implantación, proceso inflamatorio que ya cedió completamente después del día 60 y que finalmente se tornó inerte. From the material formed by means of the process of the present invention, it has been implanted in the mastoid process of a patient without any rejection, beyond a slight normal inflammation presented during its implantation, an inflammatory process that completely subsided after day 60 and that finally became inert.
Antes de implantarlo se le hicieron estudios de control de calidad físico-químico en Laboratorios STERINOVA S.A.S con registro ISO al igual que la esterilización del material. Before implanting it, physical-chemical quality control studies were carried out at Laboratorios STERINOVA S.A.S with ISO registration, as well as the sterilization of the material.
Sólo se han ¡lustrado a manera de ejemplo algunas modalidades preferidas de la invención. En este respecto, se apreciará que el proceso de conformación de implantes faciales cosméticos y reconstructivos a partir en un material basado en corcho, así como los arreglos en su configuración particular se puede escoger de una pluralidad de alternativas sin apartarse del espíritu de la invención según las siguientes reivindicaciones. Only some preferred embodiments of the invention have been illustrated by way of example. In this regard, it will be appreciated that the process of forming cosmetic and reconstructive facial implants from a cork-based material, as well as the arrangements in its particular configuration, can be chosen from a plurality of alternatives without departing from the spirit of the invention according to the following claims.

Claims

REIVINDICACIONES
1. Proceso de conformación de implantes faciales cosméticos y reconstructivos que incluye etapas preliminares de cocción y laminado del material corcho, donde el proceso además está caracterizado porque comprende: 1. Process for shaping cosmetic and reconstructive facial implants that includes preliminary stages of firing and laminating the cork material, where the process is also characterized in that it comprises:
(i) un primer paso de granulación del material corcho; (i) a first step of granulating the cork material;
(ii) un segundo paso de mezclado del material corcho en una proporción de 1000gr con 90gr de poliuretano y 45gr de silicona, mezclado con un disolvente tal como xilol en una proporción de 400ml hasta obtener una emulsión; (ii) a second step of mixing the cork material in a proportion of 1000gr with 90gr of polyurethane and 45gr of silicone, mixed with a solvent such as xylol in a proportion of 400ml until an emulsion is obtained;
(iii) un tercer paso de prensado de la masa obtenida en el segundo paso (ii), de entre 150 a 220 T/m2 para la obtención del material con una densidad de 360 kg/m3; (iii) a third step of pressing the mass obtained in the second step (ii), of between 150 to 220 T/m 2 to obtain the material with a density of 360 kg/m 3 ;
(iv) un cuarto paso de horneado del material prensado del tercer paso (iii) por un término de 6 a 8 horas a un temperatura de entre 180 y 240°C con inyección de aire de hasta 4,531 m3/min (160 ft3/min); (iv) a fourth step of firing the pressed material from the third step (iii) for a period of 6 to 8 hours at a temperature between 180 and 240°C with air injection of up to 4,531 m 3 /min (160 ft 3 /min);
(v) un quinto paso de secado del material, seguido de la conformación y moldeado del implante; y, (v) a fifth step of drying the material, followed by the shaping and molding of the implant; and,
(vi) un sexto paso donde el implante moldeado pasa por un baño de esterilización en oxido de etileno. (vi) a sixth step where the molded implant passes through an ethylene oxide sterilization bath.
2. Material de conformación de implantes faciales cosméticos y reconstructivos elaborado con el proceso según la reivindicación 1 , donde el material está caracterizado porque comprende una composición de corcho en una proporción de 70% y 90% en combinación con poliuretano en una proporción de 5 a 9% y silicona en una proporción de 2 a 5%. 2. Conformation material for cosmetic and reconstructive facial implants made with the process according to claim 1, wherein the material is characterized in that it comprises a cork composition in a proportion of 70% and 90% in combination with polyurethane in a proportion of 5 to 9% and silicone in a proportion of 2 to 5%.
3. Material de conformación de implantes según la reivindicación 2, caracterizado porque la composición de corcho tiene una proporción de 85,5%, poliuretano en una proporción de 7,69% y silicona en una proporción de 3,85%. Implant shaping material according to claim 2, characterized in that the cork composition has a proportion of 85.5%, polyurethane in a proportion of 7.69% and silicone in a proportion of 3.85%.
PCT/IB2021/057424 2021-08-12 2021-08-12 Method for forming cosmetic and reconstructive facial implants from a cork-based material and material thus constituted WO2023017297A1 (en)

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PCT/IB2021/057424 WO2023017297A1 (en) 2021-08-12 2021-08-12 Method for forming cosmetic and reconstructive facial implants from a cork-based material and material thus constituted
CONC2023/0002040A CO2023002040A2 (en) 2021-08-12 2023-02-23 Conformation process of cosmetic and reconstructive facial implants from a cork-based material and the material thus constituted

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA16907A1 (en) * 1987-04-07 1997-08-29 Інститут Монокристалів Ан України Dental implant
US20060217813A1 (en) * 2005-03-22 2006-09-28 Posnick Jeffrey C Facial implant

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA16907A1 (en) * 1987-04-07 1997-08-29 Інститут Монокристалів Ан України Dental implant
US20060217813A1 (en) * 2005-03-22 2006-09-28 Posnick Jeffrey C Facial implant

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