ES2579305B1 - PROCEDURE FOR OBTAINING AN ACTIVE IMPLANT FOR USE IN THE REGENERATION OF BONE MASS AND CORRESPONDING IMPLANT OBTAINED - Google Patents
PROCEDURE FOR OBTAINING AN ACTIVE IMPLANT FOR USE IN THE REGENERATION OF BONE MASS AND CORRESPONDING IMPLANT OBTAINED Download PDFInfo
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- ES2579305B1 ES2579305B1 ES201630548A ES201630548A ES2579305B1 ES 2579305 B1 ES2579305 B1 ES 2579305B1 ES 201630548 A ES201630548 A ES 201630548A ES 201630548 A ES201630548 A ES 201630548A ES 2579305 B1 ES2579305 B1 ES 2579305B1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/20—Polysaccharides
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
- A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
- A61L27/3645—Connective tissue
- A61L27/365—Bones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/52—Hydrogels or hydrocolloids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Oral & Maxillofacial Surgery (AREA)
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- Transplantation (AREA)
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- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
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- Orthopedic Medicine & Surgery (AREA)
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- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
Procedimiento de obtención de un implante activo de uso en la regeneración de masa ósea y correspondiente implante obtenido.#La invención se refiere a un implante activo utilizado en la regeneración de tejido óseo, de manera que el implante se obtiene a partir de un modelo tridimensional de la zona a recuperar, para imprimir dicho modelo determinando una estructura de soporte a base de un material biocompatible y biodegradable, y cuya estructura está formada por filamentos entre cuyos huecos se deposita de manera isótropa un hidrogel con factores de crecimiento óseo del tipo más apropiado, obteniéndose una capa exterior como capa protectora, membrana o piel, todo ello de manera que una vez implantada la estructura, dicho estructura es degradada y absorbida por el organismo de forma simultánea a como es suplida con el tejido óseo autógeno generado.Procedure for obtaining an active implant for use in bone mass regeneration and corresponding implant obtained. # The invention relates to an active implant used in bone tissue regeneration, so that the implant is obtained from a three-dimensional model of the area to be recovered, in order to print said model by determining a support structure based on a biocompatible and biodegradable material, and whose structure is formed by filaments between whose holes an hydrogel with bone growth factors of the most appropriate type is deposited in an isotropic manner. , obtaining an outer layer as a protective layer, membrane or skin, all this so that once the structure is implanted, said structure is degraded and absorbed by the organism simultaneously as it is supplied with the generated autogenous bone tissue.
Description
OBJETO DE LA INVENCiÓN OBJECT OF THE INVENTION
La presente invención se refiere a un procedimiento de obtención de un implante activo de uso en la regeneración de masa ósea, a partir de un modelo tridimensional de la correspondiente zona del tejido óseo a regenerar, utilizando materiales que permiten proteger el crecimiento del tejido óseo. The present invention relates to a method of obtaining an active implant for use in bone mass regeneration, from a three-dimensional model of the corresponding area of bone tissue to be regenerated, using materials that allow the growth of bone tissue to be protected.
Es igualmente objeto de la invención el implante activo que se absorbe según se regenera la masa ósea del paciente. The active implant that is absorbed as the patient's bone mass is regenerated is likewise object of the invention.
ANTECEDENTES DE LA INVENCiÓN BACKGROUND OF THE INVENTION
Los implantes utilizados en el crecimiento o regeneración de tejidos óseos se basan en la utilización de membranas animales o artificiales, con una estructura mecánica de contención del material precursor osteogénico, con un mecanismo de contención del tejido conjuntivo con el que está en contacto, de manera que de esta forma se evita que el hueso en formación sea colonizado por el tejido blando de más rápido crecimiento. The implants used in the growth or regeneration of bone tissues are based on the use of animal or artificial membranes, with a mechanical containment structure of the osteogenic precursor material, with a mechanism of containment of the connective tissue with which it is in contact, so that in this way prevents the bone in formation from being colonized by the fastest growing soft tissue.
Los procesos actuales en los que se aplican implantes activos de regeneración de masa ósea adolecen de una serie de problemas e inconvenientes tales como falta de eficacia, mínimo poder de reabsorción, requiriendo además una intervención quirúrgica posterior. The current processes in which active bone mass regeneration implants are applied suffer from a series of problems and inconveniences such as lack of efficiency, minimum resorption power, further requiring further surgical intervention.
DESCRIPCiÓN DE LA INVENCiÓN DESCRIPTION OF THE INVENTION
El procedimiento de obtención de un implante activo de uso en la regeneración de masa The procedure for obtaining an active implant for use in mass regeneration
ósea consiste en : bone consists of:
- • •
- Obtención de la geometría a recuperar mediante un TAC (tomografía), resonancia magnética, ultrasonidos o cualquier otro medio de escaneo del tejido óseo a regenerar del paciente. Obtaining the geometry to be recovered by CT (tomography), magnetic resonance imaging, ultrasound or any other means of scanning the bone tissue to be regenerated from the patient.
- • •
- Segmentación de dicho geometría escaneada y determinación del tejido óseo actual. Segmentation of said scanned geometry and determination of current bone tissue.
- • •
- Creación de un modelo tridimensional del tejido óseo a reponer. Creation of a three-dimensional model of bone tissue to replace.
- • •
- Modelización de la ruta de extrusión del modelo tridimensional creado, para compatibilizar con rango de supervivencia. Modeling the extrusion path of the three-dimensional model created, to make it compatible with the survival range.
- • •
- Impresión del implante e impregnación ¡sátrapa de una proteína ósea a base de hidrogel con factor de crecimiento óseo y sustancias osteinductoras como hueso liofilizado en polvo. Implant impression and impregnation ¡satrap of a hydrogel-based bone protein with bone growth factor and osteinductive substances such as lyophilized bone powder.
• •
• Fijación del implante obtenido en el paciente. • Implant fixation obtained in the patient.
Es igualmente objeto de la invención el implante obtenido y utilizado para regenerar masa ósea, de manera que dicho implante se obtiene a partir de un modelo tridimensional de la zona del tejido óseo del paciente a recuperar, creándose un modelo tridimensional personalizado para seguidamente imprimir una estructura de soporte a partir de la cual se obtiene el implante en cuestión, a base de un material biocompatible y biodegradable PLLA (Poly-L-Iactide) o similar, que puede estar en combinación con PDLA (Poly-D-Iactide) en una proporción adecuada. The implant obtained and used to regenerate bone mass is likewise object of the invention, so that said implant is obtained from a three-dimensional model of the area of the bone tissue of the patient to be recovered, creating a custom three-dimensional model to then print a structure. of support from which the implant in question is obtained, based on a biocompatible and biodegradable material PLLA (Poly-L-Iactide) or the like, which may be in combination with PDLA (Poly-D-Iactide) in a proportion adequate.
La estructura de soporte se obtiene a base de filamentos del material biocompatible biodegradable anteriormente comentado, con la forma del modelo tridimensional creado, con la particularidad de que en dicha estructura se inyecta, sobre los huecos de la misma, un hidrogel con factores de crecimiento óseo como material orgánico osteoinductor, añadiéndose además un relleno de polvo de hueso liofilizado, con la especial particularidad de que el depositado o aplicación por inyección del hidrogel osteoinductor se realiza de manera isótropa sobre la propia estructura. The support structure is obtained based on filaments of the biodegradable biocompatible material mentioned above, in the form of the three-dimensional model created, with the particularity that a hydrogel with bone growth factors is injected into said structure as an osteoinductive organic material, with a lyophilized bone powder filling being added, with the particular feature that the deposition or application by injection of the osteoinducting hydrogel is done isotropically on the structure itself.
El implante así constituido tiene una capa definida como exterior que contiene una serie de filamentos más estrechamente depositados, configurando una capa protectora que puede The implant thus constituted has an outer defined layer that contains a series of more closely deposited filaments, configuring a protective layer that can
denominarse "piel" o "membrana". be called "skin" or "membrane".
De esta forma todo el material de la estructura será degradado y absorbido por el organismo, según aumente el tejido óseo inducido o regenerado, creciendo a un ritmo acelerado por las señales químicas del factor de crecimiento óseo con el que se ha impregnado los filamentos. In this way all the structure material will be degraded and absorbed by the organism, as the induced or regenerated bone tissue increases, growing at an accelerated rate by the chemical signals of the bone growth factor with which the filaments have been impregnated.
La capa exterior del implante protege el crecimiento del tejido óseo de la agresión del epitelial mucho más rápido, y que en los procesos actuales se realiza con membranas animales o artificiales. The outer layer of the implant protects the growth of bone tissue from aggression of the epithelial much faster, and that in current processes is performed with animal or artificial membranes.
El proceso de impresión en 3D se realiza mediante fusión del material biocompatible con deposición de material biológico, de manera que la temperatura de fusión del material biocompatible que es entre 175-240°C. The 3D printing process is carried out by fusion of the biocompatible material with deposition of biological material, so that the melting temperature of the biocompatible material is between 175-240 ° C.
El procedimiento modula la cantidad de material dispuesto por unidad de volumen para permitir que la inercia térmica del hidrogel osteoinductor, donde está disuelto el espécimen biológico, se mantenga en un rango de temperaturas que permita una alta supervivencia al proceso. The procedure modulates the amount of material arranged per unit volume to allow the thermal inertia of the osteoinducting hydrogel, where the biological specimen is dissolved, to be maintained in a temperature range that allows high process survival.
Tal y como se ha comentado anteriormente, la integración del hidrogel osteoinductor sobre la estructura se realiza de forma isótropa de manera que dado el pequeño tamaño de los huecos creados (300 micras aproximadamente) en la estructura resultará óptimo para el crecimiento de los osteocitos, resultando incompatible con procesos de impregnación posteriores, dada la alta viscosidad del hidrogel a la temperatura de trabajo, no siendo práctiCOS los procesos de capilaridad para un relleno óptimo de la estructura. As previously mentioned, the integration of the osteoinducting hydrogel on the structure is carried out in an isotropic way so that given the small size of the holes created (approximately 300 microns) in the structure it will be optimal for the growth of the osteocytes, resulting Incompatible with subsequent impregnation processes, given the high viscosity of the hydrogel at the working temperature, capillarity processes are not practical for optimal filling of the structure.
En definitiva, se trata de un solo elemento del material precursor de regeneración ósea con una estructura rígida de contención y membrana protectora, añadida esta como membrana adicional para conseguir una aplicación más sencilla y fácil. In short, it is a single element of the bone regeneration precursor material with a rigid containment structure and protective membrane, added as an additional membrane to achieve a simpler and easier application.
Solo resta señalar por último que el material biocompatible y biodegradable PLLA es un ácido poliláctico, tipo PURALACT® o similar, mientras que el hidrogel es en una It only remains to point out finally that the biocompatible and biodegradable material PLLA is a polylactic acid, type PURALACT® or similar, while the hydrogel is in a
combinación de materiales orgánicos y no orgánicos entre os cuales incluye el factor de crecimiento óseo BMP2 en proporción entre el 0,25 y 2.5 mg/mL y hueso en polvo liofilizado además de otros componentes. combination of organic and non-organic materials among which includes BMP2 bone growth factor in proportion between 0.25 and 2.5 mg / mL and lyophilized bone powder in addition to other components.
5 De esta forma, el material que constituye el implante, se desintegrará en contacto con los fluidos de los tejidos circundantes, siendo metabolizado por el organismo y generando un volumen vacío que es ocupado por el tejido óseo regenerado, de manera tal que la utilización de los factores de crecimiento óseo acelera la generación del tejido óseo en un orden del 30%-40% respecto del ritmo normal según el caso. 5 In this way, the material that constitutes the implant will disintegrate in contact with the fluids of the surrounding tissues, being metabolized by the organism and generating an empty volume that is occupied by the regenerated bone tissue, so that the use of Bone growth factors accelerates the generation of bone tissue in an order of 30% -40% with respect to the normal rhythm as appropriate.
DESCRIPCiÓN DE LOS DIBUJOS DESCRIPTION OF THE DRAWINGS
Para complementar la descripción que seguidamente se va a realizar y con objeto de ayudar To complement the description that will then be made and in order to help
15 a una mejor comprensión de las características del invento, de acuerdo con un ejemplo preferente de realización práctica del mismo, se acompaña como parte integrante de dicha descripción, un juego de planos en donde con carácter ilustrativo y no limitativo, se ha representado lo siguiente: 15 to a better understanding of the features of the invention, in accordance with a preferred example of practical realization thereof, is attached as an integral part of said description, a set of drawings in which with the illustrative and non-limiting nature, the following has been represented :
20 La figura 1.-Muestra una vista en perspectiva de un modelo tridimensional de una zona de tejido óseo a recuperar con un implante realizado de acuerdo con el objeto de la presente invención. Figure 1.- Shows a perspective view of a three-dimensional model of an area of bone tissue to be recovered with an implant made in accordance with the object of the present invention.
La figura 2.-Muestra una vista en sección de otro implante, y en el que aparece 25 representada la membrana exterior que se dispone recubriendo el implante. Figure 2 shows a sectional view of another implant, and in which the outer membrane that is arranged covering the implant is shown.
REALIZACiÓN PREFERENTE DE LA INVENCiÓN PREFERRED EMBODIMENT OF THE INVENTION
30 A la vista de las figuras reseñadas, puede observarse como el implante de la invención, previsto para su utilización en la regeneración de una zona de tejido óseo a recuperar (1), está constituido por una estructura (2) a base de filamentos, obtenida a partir de la creación de un modelo tridimensional personalizado, de manera que esa estructura (2) de soporte está formada por filamentos de sección cilíndrica que generan unos huecos de entre 100 a 350 micras, teniendo la forma del modelo creado y estando materializada en un material biocompatible y biodegradable, depositando en la estructura (2), de forma inyectada y entre In view of the figures outlined, it can be seen how the implant of the invention, intended for use in the regeneration of an area of bone tissue to be recovered (1), is constituted by a structure (2) based on filaments, obtained from the creation of a custom three-dimensional model, so that support structure (2) is formed by cylindrical filaments that generate gaps between 100 to 350 microns, having the shape of the model created and being materialized in a biocompatible and biodegradable material, depositing in the structure (2), injected and between
5 los huecos que forman los filamentos de la misma, una proteína ósea o hidrogel, con material orgánico osteoinductor, efectuándose ese proceso de una manera ¡sátrapa, constituyendo la capa exterior una capa protectora o piel (3), siendo esa estructura (2) degradada y absorbida por el organismo, según aumente y se regenere el tejido óseo inducido. 5 the holes that form the filaments thereof, a bone protein or hydrogel, with osteoinductive organic material, this process being carried out in a satrap manner, the outer layer constituting a protective layer or skin (3), that structure (2) being degraded and absorbed by the organism, as the induced bone tissue is increased and regenerated.
10 Dicha piel (3) que no entra en contacto con el hueso, está obtenida a base de filamentos adyacentes o superpuestos conformando una lámina porosa. Said skin (3) that does not come into contact with the bone, is obtained based on adjacent or superimposed filaments forming a porous sheet.
Claims (4)
- • •
- Segmentación de dicha geometría y determinación del tejido óseo actual. Segmentation of said geometry and determination of current bone tissue.
- • •
- Creación de un modelo tridimensional del tejido a regenerar. Creation of a three-dimensional model of the tissue to regenerate.
- • •
- Modelización de la ruta de extrusión del modelo 3D para compatibilizar durante el Modeling of the 3D model extrusion path to make it compatible during
- • •
- Impresión del modelo 3D e impregnación isótropa sobre el mismo de un hidrogel con factor de crecimiento óseo-como material orgánico osteoinductor. 3D model printing and isotropic impregnation on it of a hydrogel with bone growth factor-like osteoinducting organic material.
- 28 ._ Implante activo de uso en la regeneración de masa ósea, obtenido a partir del procedimiento de la reivindicación 18, caracterizado porque consiste en una estructura 3D de un material biocompatible y biodegradable, con la forma del modelo tridimensional creado, con una impregnación de un hidrogel con factor de crecimiento óseo, incorporando un relleno de polvo de hueso liofilizado. 28 ._ Active implant for use in bone mass regeneration, obtained from the method of claim 18, characterized in that it consists of a 3D structure of a biocompatible and biodegradable material, in the form of the created three-dimensional model, with an impregnation of a hydrogel with bone growth factor, incorporating a lyophilized bone powder filler.
- 38 ._ Implante activo de uso en la regeneración de masa ósea, según reivindicación 28, caracterizado porque los filamentos interiores de la estructura 3D son de sección cilíndrica y definen huevos vacíos del orden de entre 100 Y 350 micras. 38 ._ Active implant for use in bone mass regeneration, according to claim 28, characterized in that the inner filaments of the 3D structure are cylindrical in section and define empty eggs of the order of between 100 and 350 microns.
- 48 ._ Implante activo de uso en la regeneración de masa ósea, según reivindicación 28, caracterizado porque en el mismo se rellenan los huecos de la estructura con un hidrogel osteinductor durante el proceso de impresión de la estructura. 48 ._ Active implant for use in bone mass regeneration, according to claim 28, characterized in that the holes in the structure are filled with an osteinductor hydrogel during the printing process of the structure.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES201630548A ES2579305B1 (en) | 2016-04-29 | 2016-04-29 | PROCEDURE FOR OBTAINING AN ACTIVE IMPLANT FOR USE IN THE REGENERATION OF BONE MASS AND CORRESPONDING IMPLANT OBTAINED |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES201630548A ES2579305B1 (en) | 2016-04-29 | 2016-04-29 | PROCEDURE FOR OBTAINING AN ACTIVE IMPLANT FOR USE IN THE REGENERATION OF BONE MASS AND CORRESPONDING IMPLANT OBTAINED |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| ES2579305A1 ES2579305A1 (en) | 2016-08-09 |
| ES2579305B1 true ES2579305B1 (en) | 2017-03-24 |
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| Application Number | Title | Priority Date | Filing Date |
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| ES201630548A Expired - Fee Related ES2579305B1 (en) | 2016-04-29 | 2016-04-29 | PROCEDURE FOR OBTAINING AN ACTIVE IMPLANT FOR USE IN THE REGENERATION OF BONE MASS AND CORRESPONDING IMPLANT OBTAINED |
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Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6294187B1 (en) * | 1999-02-23 | 2001-09-25 | Osteotech, Inc. | Load-bearing osteoimplant, method for its manufacture and method of repairing bone using same |
| WO2014144488A1 (en) * | 2013-03-15 | 2014-09-18 | The George Washington University, A Congressionally Chartered Not-For-Profit Corporation | 3d biomimetic, bi-phasic key featured scaffold for osteochondral repair |
| US20150037385A1 (en) * | 2013-08-02 | 2015-02-05 | Northwestern University | Ceramic-containing bioactive inks and printing methods for tissue engineering applications |
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| ES2579305A1 (en) | 2016-08-09 |
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