专利摘要:
Procedure for obtaining an active implant for use in the regeneration of bone mass and corresponding implant obtained. The invention relates to an active implant used in the regeneration of bone tissue, so that the implant is obtained from a three-dimensional model of the area to be recovered, to print said model determining a support structure based on a biocompatible material and biodegradable, and whose structure is formed by filaments between whose holes isotropically deposited a hydrogel with bone growth factors of the most appropriate type, obtaining an outer layer as a protective layer, membrane or skin, all this so that once implanted the structure, said structure is degraded and absorbed by the organism simultaneously as it is supplied with the generated autogenous bone tissue. (Machine-translation by Google Translate, not legally binding)
公开号:ES2579305A1
申请号:ES201630548
申请日:2016-04-29
公开日:2016-08-09
发明作者:Luis Alberto RUIZ DE OLANO APODACA
申请人:Optimus 3D SL;
IPC主号:
专利说明:

PROCEDURE FOR OBTAINING AN ACTIVE IMPLANT FOR USE IN THEBONE AND CORRESPONDING MASS REGENERATION IMPLANT OBTAINED
OBJECT OF THE INVENTION
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.
The active implant that is absorbed as the patient's bone mass is regenerated is likewise object of the invention. BACKGROUND OF THE INVENTION
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.
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.
DESCRIPTION OF THE INVENTION
The procedure for obtaining an active implant for use in mass regeneration


bone consists of:
 Obtaining the geometry to be recovered by CT (tomography), resonance
magnetic, ultrasound or any other means of scanning bone tissue at
Regenerate from the patient.
 Segmentation of said scanned geometry and determination of current bone tissue.
 Creation of a three-dimensional model of bone tissue to replace.
 Modeling of the extrusion path of the three-dimensional model created, for
make compatible with survival range.
 Implant impression and isotropic impregnation of a bone protein based on
hydrogel with bone growth factor and osteinductive substances such as bone
freeze dried powder.

 Implant fixation obtained in the patient.
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-lactide) or the like, which may be in combination with PDLA (Poly-D-lactide) in a proportion adequate.
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.
The implant thus constituted has an outer defined layer that contains a series of more closely deposited filaments, configuring a protective layer that can


be called "skin" or "membrane."
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.
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.
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.
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.
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, the capillary processes being not practical for an optimal filling of the structure.
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.
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


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.
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 the Bone growth factors accelerates the generation of bone tissue in an order of 30% -40% with respect to the normal rhythm as appropriate. DESCRIPTION OF THE DRAWINGS
To complement the description that will then be made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of practical implementation thereof, a set of drawings is attached as an integral part of said description. where, for illustrative and non-limiting purposes, the following has been represented:
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.
Figure 2.- Shows a sectional view of another implant, and in which the outer membrane that is arranged covering the implant is represented. PREFERRED EMBODIMENT OF THE INVENTION
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 the holes that form the filaments thereof, a bone protein or hydrogel, with osteoinductive organic material, this process being carried out in an isotropic 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 increases and regenerates.
Said skin (3) that does not come into contact with the bone, is obtained based on adjacent or superimposed filaments forming a porous sheet.

权利要求:
Claims (1)
[1]

1st.- Procedure for obtaining an active implant for use in bone mass regeneration, based on a geometry to be retrieved by means of a CT (tomography) / Magnetic resonance imaging, ultrasound or any other means of scanning the bone tissue to be regenerated. patient, it is characterized in that the following operational phases are defined in it:
 Segmentation of said geometry and determination of current bone tissue.
 Creation of a three-dimensional model of the tissue to regenerate.
 Modeling of the 3D model extrusion path to make it compatible during the
manufacturing process a survival range of suitable organic material
for use
 3D model printing and isotropic impregnation on it of a hydrogel with
bone growth factor as an osteoinductive organic material.
2nd.- Active implant for use in bone mass regeneration, obtained from the procedure of claim 1, characterized in that it consists of a 3D structure of a biocompatible and biodegradable material, in the form of the three-dimensional model created, with an impregnation of a hydrogel with bone growth factor, incorporating a lyophilized bone powder filler.
3rd.- Active implant for use in bone mass regeneration, according to claim 2, 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.
4th.- Active implant for use in bone mass regeneration, according to claim 2, characterized in that the holes in the structure are filled with an osteinductor hydrogel during the printing process of the structure.
5th.- Active implant for use in bone mass regeneration, according to claim 2, characterized in that an outer layer of the structure is defined, which does not enter

in contact with the bone, based on adjacent or superimposed filaments forming a porous sheet.
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同族专利:
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引用文献:
公开号 | 申请日 | 公开日 | 申请人 | 专利标题
ES2261191T3|1999-02-23|2006-11-16|Osteotech, Inc.|MANUFACTURING PROCEDURE OF A OSEO IMPLANT.|
US20160067375A1|2013-03-15|2016-03-10|The George Washington University, A Congressionally Chartered Not-For-Profit Corporati|3d biomimetic, bi-phasic key featured scaffold for osteochondral repair|
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法律状态:
2021-10-01| FD2A| Announcement of lapse in spain|Effective date: 20211001 |
优先权:
申请号 | 申请日 | 专利标题
ES201630548A|ES2579305B1|2016-04-29|2016-04-29|PROCEDURE FOR OBTAINING AN ACTIVE IMPLANT FOR USE IN THE REGENERATION OF BONE MASS AND CORRESPONDING IMPLANT OBTAINED|ES201630548A| ES2579305B1|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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