• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
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  • 优先权
    • 专利摘要:
    Suitable composite material for human body implant, prosthetic implant, and method for implant manufacturing are prosthetic implant material for use in a prosthetic implant, which comprises a gel and optionally a gas.
    公开号:BR112012017536B1
    申请号:R112012017536-0
    申请日:2011-01-18
    公开日:2019-04-09
    发明作者:Haim Dvir；Dael Govreen-Segal
    申请人:G & G Biotechnology Ltd.；
    IPC主号:
    专利说明:

    [001] The present invention relates, in general, to implantable prosthetic devices and, specifically, to implantable low weight prosthetic devices, which have material that has relatively low density.
    BACKGROUND OF THE INVENTION [002] In the past century, plastic and reconstructive surgery has become a common practice. Specifically, breast plastic surgery was developed to allow the reconstruction of the breast of a woman who was affected by procedures such as mastectomy. Plastic breast surgery has also become available to correct the appearance of a woman's breast, for example, by adding an implant to increase the size of the breast, to improve asymmetries, change the shape and correct deformities.
    [003] For plastic and reconstructive surgery, the implant is necessary because it is able to provide a specific three-dimensional shape and maintain the shape for many years, preferably throughout the life of the woman (or man, depending on the type of surgery) in which the implant is installed to prevent the need for additional invasive surgery. The implant is also necessary because it has a specific sensation, preferably imitating the sensation of human tissue, like the sensation of a real breast. The implant also needs to be biodurable in a way that is not destroyed by interaction with the human body; and it must be biocompatible so that the patient's health is not adversely affected
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    2/40 for the implant even in extreme circumstances: for example, the implant must be non-toxic in case of leakage of the implant.
    [004]
    Standard implants used today for breast implant surgery, for example, comprise an outer liner typically formed of vulcanized silicone rubber (elastomer) that can be single or multiple layer, smooth or textured, barrier-coated, or covered with foam polyurethane; and an internal content typically formed by silicone gel or inflated during surgery with saline. An average implant can weigh between 50 and 1,000 grams, or even more. The specific weight of the commonly used padding materials is generally between 0.95 and 1.15 grams per cubic centimeter volume, similar to the specific weight of natural breast tissue.
    [005] Nevertheless, natural breast tissue is living tissue that goes through a common natural life cycle just like any other tissue in the body, while a breast implant is a dead weight added to the breast tissue. Natural breast tissue and breast implants are subjected to the force of gravity. The most common response of natural breast tissue and breast implants to gravity is sagging over time. The rate of flaccidity is increased in the implants since the implants are a dead weight.
    [006]
    Over time, breast implants are known to cause many problems, especially in relation to the weight of the implant, for example: ptosis (ie, flaccidity and deformity), atrophy of breast tissue,
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    3/40 implant prominence through breast tissue, back pain, and stretch marks on the skin. Thus, the weight of the implant is an important factor in post-surgical comfort and appearance.
    [007] Traditionally, the silicone gels used as fillers had silicone oils that have small liquid molecules such as cyclic or linear silicones, silicone oligomers and low molecular weight silicone polymer chains that were drained through the coating over time. Current implants involve using a coating with barrier layers to achieve very low permeability of those chemical portions of liquid. In addition, the silicone gel used in breast implants is considered a cohesive gel. Cohesion ensures that the filling material does not flow easily and spreads in the body in the event of a break in the coating; it also significantly reduces the diffusion of silicone oil through the coating.
    [008] An additional characteristic to be considered when selecting the filling material is the resilience, elasticity and malleability of the implant, which endows it with a specific sensation when it is felt. It is generally desirable to provide an implant that provides a specific shape and mimics the feel of real human tissue in the position of the implant. It is important that the implant maintains its feel and shape for extended periods to prevent the need for additional surgery.
    [009] Gonzales Patent Application Publication No. 2004/0153151 on August 5, 2004 describes a silicone breast prosthesis that is formed as a body
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    4/40 trabecular or microcellular body in order to obtain a lower density prosthesis.
    [010] U.S. Patent No. 4,380,569 to Shaw on April 19, 1983 describes a lightweight breast prosthesis that is used outside the human body or implanted in the human body. The breast prosthesis consists of a mixture of a silicone gel and glass microspheres.
    [011] US Patent No 5,902,335 :: Snyder, Jr. on May 11 , 1999 , describes a reduced - weight breast prosthesis which is used outside the human body. Snyder claims that the use of glass microspheres as described by Shaw results in a rigid product that does not mimic the human breast as well as silicone gel alone. Snyder describes
    a prosthesis breast that has two sections. An first section external filled with gel in silicone what imitates the breast human is second section internal of Weight reduced for reduce the weight prosthesis. [012] The Patent at the U.S. 5,658.33 0, by Carlisle
    et al. on August 19, 1997 describes a molded silicone foam implant and method for producing it.
    SUMMARY OF THE INVENTION [013] The prior art does not teach or suggest a prosthetic implant material that is low enough in density to provide a low weight implant and that also looks and feels real when implanted.
    [014] The present invention overcomes these drawbacks of the prior art by providing an implant material, which can be considered as a material
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    5/40 composite instead of just a mixture, which has low density and real appearance and feel through the implant. The implant material is suitable for use in an encapsulated implant according to at least some embodiments of the present invention, wherein the implant has a coating and the implant material, so that the implant material is contained in the coating.
    [015] In accordance with preferred embodiments of the present invention, the encapsulated implant is adapted for use as a breast implant.
    [016] According to at least some embodiments of the present invention, the implant material comprises a gel, such as silicone gel, and a material of lower density. The density of the silicone gel is ~ 1 gr / cm 3 in the order of densities of other liquids, such as water and organic solvents. The lower density material, therefore, has a density of less than ~ 1 gr / cm3. Optionally and preferably, the lower density material comprises a gas.
    [017] In an exemplary embodiment of the invention, the reduced weight prosthesis can be supplied in various sizes, for example, ranging from 50 cm3 to 1,500 cm3 or greater or less. Optionally, a lightweight prosthesis can be implanted in other areas of the body other than the breast, for example, to replace or enlarge the testicles, pectorals, chin, cheeks, calves, buttocks or other parts of the human or animal body, while exhibiting properties tactiles similar to natural fabric.
    [018] In accordance with at least some embodiments of the present invention, a material is provided
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    6/40 composite suitable for implantation in the human body, comprising a polymeric gel and a plurality of surface-treated additives, wherein the surface-treated additives comprise a surface that has a reactive cross-linking group to cross-link the gel in a manner that surface-treated additives are cross-linked to the gel. Optionally, the polymeric gel comprises a reactive crosslinking group to crosslink the additives and the gel. Optionally, the polymeric gel comprises a polymer that has at least two reactive cross-linking groups per monomer unit of the polymer. Optionally, the additives comprise a plurality of solid capsules.
    [019] Optionally, the additives comprise a plurality of hollow lumens. Optionally, the plurality of lumens comprises a macrolumen. Optionally, the plurality of lumens comprises a combination of at least one macrolumen and a plurality of microlumens. Optionally, the plurality of lumens comprises a plurality of layered macrolumens.
    [020] Optionally, the additives comprise a plurality of hollow microlumens. Optionally, the microlumens contain a gas. Optionally, the microlumens contain at least a partial vacuum up to 0.9 atm (91.2 kPa).
    [021] Optionally, microlumens withstand pressures of more than 300 psi (20 MPa) (> 20 atm) (> 2,026.5 kPa) without breaking or collapsing.
    [022] Optionally, microlumens are made of ceramic, plastic, glass, PMMA (polymethylmethacrylate), polyacrylonitrile, polybutadiene, natural or synthetic rubber.
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    7/40
    [023] Optionally, the microlumens no are rigid then the material comprises up to 90% in v / v in microlumens. [024] Optionally, the microlumens has one diameter from 1 micron to 500 microns.[025] Optionally, the microlumens has an
    plurality of different diameters.
    [026] Optionally, the surface has a molecule selected from the group consisting of a long chain fatty acid, another long organic chain, a polymer brush; polystyrenes, organofunctional silanes, zirconates, and titanates. Optionally, the polymeric gel comprises silicone gel. Optionally, the silicone gel comprises PDMS or a derivative thereof.
    [027]
    Optionally, the additives are evenly dispersed in the gel.
    [028]
    Optionally, the composite material is adapted to mask the additives of a fabric by the polymeric gel.
    [029] In accordance with at least some embodiments of the present invention, a prosthetic implant is provided, comprising a coating and the composite material, as described in this document.
    Optionally, the composite material comprises up to 60% by volume / volume of microlumens in relation to the polymeric gel.
    Optionally, the implant has a volume of 50 cm 3 to 1,500 cm 3 .
    [030]
    Optionally, the coating comprises a plurality of layers.
    [031]
    Optionally, the coating comprises
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    8/40 a silicone elastomer.
    [032] Optionally, the coating also comprises polyurethane foam superimposed on an external coating surface.
    [033] Optionally, the implant comprises a plurality of coatings, including at least one inner liner and at least one outer liner, wherein the at least one inner liner is at least partially surrounded by the outer liner, in which the outer liner is filled with the composite material that has a first percentage of microlumens, and the inner lining is filled with the composite material that has a second percentage of microlumens, where the first and second percentages are different.
    [034] Optionally, a ratio between the first and second percentages is in the range of 1: 1 to 1: 5.
    [035] Optionally, the first percentage is 30% by volume / volume, and the second percentage is 50% by volume / volume.
    [036] In accordance with at least some embodiments, a method is provided for making an implant as described in this document, which comprises mixing the polymeric gel and the additives, filling the coating with the polymeric gel and the additives, and rotating the coating for the cure.
    [037] Optionally, the polymeric gel comprises silicone, and in which the silicone is prepared from a plurality of components, the method further comprising mixing the plurality of silicone components before mixing in the additives.
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    9/40 [038] Optionally, the method also comprises drying the additives before mixing the additives in the silicone.
    [039] According to at least some modalities, a therapeutic, aesthetic and / or cosmetic treatment method is provided, which comprises implanting the prosthetic implant, as described in this document, in an individual.
    [040] Optionally, the method comprises implanting the implant to replace or enlarge a breast,
    testicle, chest, chin, cheek, calf, or gluteus.[041] According with at minus some modalities, is provided one implant prosthetic, which comprises one coating, one polymeric gel and a plurality in hollow microlumens, on what the microlumens understand an surface, in what the surface comprises a
    treatment to interact with the polymeric gel to form a covalent or non-covalent bond, in which the polymeric gel and microlumens are contained in the coating.
    [042] Optionally, the covalent or non-covalent bond increases the adhesion of the microlumens to the polymeric gel.
    [043] Optionally, the treatment comprises the attachment of a plurality of molecules to the surface.
    [044] Optionally, the plurality of molecules is selected from the group consisting of a long chain fatty acid, another long organic chain, a polymer brush; polystyrenes, organofunctional silanes, zirconates, titanates, and a molecule to increase electrostatic interactions.
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    10/40 [045]
    Optionally, the plurality of molecules comprises n-propyltrimethoxysilane.
    [046]
    Optionally, polymeric gel comprises a silicone gel.
    [047]
    Optionally, the silicone gel comprises PDMS or a derivative thereof.
    [048]
    Optionally, the plurality of molecules comprise n-propyltrimethoxysilane, npropyltrimethoxysilane and the silicone gel are subjected to a catalyzed curing reaction to crosslink the npropyltrimethoxysilane to the silicone gel.
    [049]
    Optionally, treatment comprises roughening the surface.
    [050]
    Optionally, it comprises up to 60% by volume / volume of microlumens composite material in relation to the polymeric gel.
    [051]
    Optionally, a prosthetic implant has a volume of 50 cm 3 to 1,500 cm3.
    [052]
    Optionally, the coating comprises a plurality of layers.
    [053]
    Optionally, the coating comprises a silicone elastomer.
    [054]
    Optionally, the coating further comprises polyurethane foam superimposed on an external coating surface.
    [055] Optionally, the implant comprises a plurality of coatings, including at least one inner lining and at least one outer lining, wherein the at least one inner lining is at least partially surrounded by the outer lining, where the
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    11/40 outer lining is filled with the composite material that has a first percentage of microlumens, and the inner lining is filled with the composite material that has a second percentage of microlumens, where the first and second percentages are different.
    [056] Optionally, a ratio between the first and second percentages is in the range of 1: 1 to 1: 5.
    [057] Optionally, the first percentage is 30% by volume / volume, and the second percentage is 50% by volume / volume.
    [058] Optionally, the microlumens are homogeneously dispersed in the gel.
    [059] According to at least some modalities, the use of a surface treatment on a microlumen surface in a polymeric gel is provided to mask the microlumen of a biological tissue, where the surface treatment comprises a reactive crosslinking group fixed to the surface, where the reactive crosslinker group forms a covalent crosslinker with the polymeric gel.
    [060] According to at least some modalities, the use of a surface treatment on a microlumen surface in a polymeric gel is provided to provide a more radiolucent implant (permeable to x-ray), where the surface treatment comprises a reactive crosslinking group attached to the surface, in which the reactive crosslinking group forms a covalent crosslinking link with the polymeric gel, and where the use further comprises preparing an implant with the crosslinked polymeric gel / microlumen.
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    12/40 [061] It should be noted that the composite material, as described in this document, can optionally be implanted as an external prosthesis and / or other usable external elements, which includes, but is not limited to shoe soles, a bulletproof vest or other clothing items.
    [062] Unless otherwise defined, all technical and scientific terms used in this document have the same meaning as commonly understood by someone with common skill in the technique to which this invention belongs. The materials, methods and examples provided in this document are illustrative only and are not intended to be limiting.
    [063] The implementation of the method and system of the present invention involves performing or completing certain tasks or steps selected manually, automatically, or a combination of them.
    BRIEF DESCRIPTION OF THE DRAWINGS [064] The invention is described in this document, by way of example only, with reference to the attached drawings. With specific reference now to the drawings in detail, it is emphasized that the particulars are shown by way of example and only for the purpose of illustrative discussion of the preferred modalities of the present invention, and are presented in order to provide what is believed to be the more useful and readily understood description of the principles and conceptual aspects of the invention. In this context, it is not intended to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description considered
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    13/40 with the drawings makes it apparent to those versed in
    technique like the various forms of the invention can be incorporated into practice. [065] In the drawings: [066] Figure 1 shows an example not
    limitation of an illustrative prosthetic encapsulated implant,
    according at least some modalities of this
    invention;
    [067] Figure 2 shows another example not
    limitation of an illustrative prosthetic encapsulated implant,
    according at least some modalities of this
    invention;
    [068] Figure 3 shows yet another example not
    limitation of an illustrative prosthetic encapsulated implant,
    according at least some modalities of this
    invention;
    [069] Figure 4 shows yet another example not
    limitation of an illustrative prosthetic encapsulated implant,
    according at least some modalities of this
    invention;
    [070] Figures 5 A and 5B show another willingness to yet another non-limiting example of a
    illustrative prosthetic encapsulated implant, in accordance with at least some embodiments of the present invention; and
    [071] Figure 6 shows the results of a experiment of dynamic simple shear flow
    (sinusoidal) where a small cyclic strain is imposed on the sample and the stress response is measured.
    DESCRIPTION OF PREFERENTIAL MODALITIES
    [072] The present invention provides a material
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    14/40 implant that has low density and real appearance and sensation through the implant, which, according to at least some modalities, comprises a composite material that presents a gel, such as silicone gel, for example, and an additive, which can optionally contain a gas. The implant material is preferably contained in a coating to form a prosthetic encapsulated implant. At least the coating, but preferably all materials of the implant, is biologically compatible and safe for therapeutic and / or cosmetic use internal to the human body. The additive may optionally comprise any three-dimensional object, be it solid or hollow, and may, for example, comprise at least one lumen, which may optionally be a macrolumen or a microlumen, or a combination thereof. As described in this document, microlumens can optionally take any suitable form, which includes, but is not limited to, microspheres, microlumens or micron sized particles such as porous particles to form a composite material.
    MICROLUMS [073] According to some modalities, the gas comprises microlumens sized in microns, which can optionally, for example, be implanted as hollow microlumens. Microlumens can optionally be made of rigid materials, which include, but are not limited to glass, ceramics, etc. However, rigid materials can optionally have a lower concentration in the gel due to a low packaging factor where the microlumens are in contact with each other. The packing factor can be increased to some extent using polydispersity of
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    Therefore, according to at least some embodiments of the present invention, the microlumens comprise particles of a plurality of different sizes, preferably of at least 20% difference between them. In any case, the microlumens can optionally have a diameter that is, more preferably, from 1 micron to 500 microns.
    [074] According to at least some embodiments of the present invention, the microlumen comprises one or more soft or flexible materials such as polymers, such as PMMA (polymethylmethacrylate), polyacrylonitrile, polybutadiene (or any other natural or synthetic rubber or similar materials), for example example, or any other amorphous or semi-crystalline polymer. Materials can optionally be determined according to their relative flexibility. For example, for PMMA, the yield strength is preferably 52 to 71 megapascals and the tensile modulus is preferably 2.2 to 3.1 gigapascals. For these more flexible polymers, the packing factor can be increased to an order of ~ 0.9 and above, so that the boundaries between two adjacent microlumens are in surface contact like soap bubbles, as opposed to the tangent contact in rigid spheres. More preferably, a mixture of polymers is used, for example, a mixture of a polymer such as PMMA and a rubber material such as polybutadiene, for example.
    [075] The terms microlumen and microsphere are used interchangeably throughout the text.
    MACROLUMS [076] According to at least some other
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    16/40 modalities, the gas is supplied in the form of at least one macroscopic lumen containing the gas. The lumen may optionally comprise a single lumen in different geometries, including one or more within a semisphere, a disc or other shape attached to a portion of the coating, for example, on the back of the coating; a lumen that floats on the gel.
    [077] The at least one macrolumen can optionally comprise a plurality of lumens; however, preferably, the total volume of the plurality of macrolumens has the same or similar volume as that of the single largest macrolumen. The shapes can be small spheres or spaghetti-like rods that float in the gel. The shaped lumens can optionally comprise a plurality of stacked layers, whether flat or curved; in the latter case, the curvature is preferably determined according to the shape of the implant. Each macrolumen can optionally have one (some) internal or external structural element (s), or a combination of them, to maintain the three-dimensional shape of the lumen, which includes, but is not limited to, a hive, etc.
    COMBINATIONS OF LUMENS [078] In order to further decrease the weight of the implant, according to at least some embodiments of the present invention, combinations of a gel with microspheres and macroscopic lumens filled with gas can be incorporated. In such an arrangement, preferably, the gel containing microspheres, preferably at least partly surrounds the macroscopic lumen (s), more preferably, in a portion of the coating that is
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    17/40 located closer to the skin or is otherwise closer to a portion of tissue that can be felt through external touch. For example, the interior of the prosthesis lining could optionally be arranged with an external layer of 50% in v / v of microspheres, an average layer of 30% in v / v of microspheres and an external macrolumen filled with gas.
    COMPOSITE MATERIALS [079] According to at least some embodiments of the present invention, the implant comprises a composite material formed through a combination of, and interaction between, additives such as microlumens and gel (or optionally between one or more macrolumens and gel). The term additive can optionally comprise any three-dimensional shape that has a treatable surface.
    [080] A polymeric composite can be seen as a mixture of several additives that have different and distinct functionalities, and a polymeric matrix that agglomerates and bonds them together for the purpose of forming a polymer based material with enhanced properties well above the intrinsic properties of the polymer or to ensure new properties therein, so that the composite material described herein can be clearly contrasted with prior art gel / glass microsphere mixtures.
    [081] According to the prior art, the glass microspheres are added to a silicone gel which is a cross-linked polymeric network to form a simple mixture, where the gel is the continuous phase and the microspheres are the dispersed phase. In such a simple mixture, each component
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    18/40 maintains its own properties, so that the density of the mixture is reduced according to a simple linear combination of the two materials.
    [082] In contrast, the composite material, according to at least some embodiments of the present invention, has composite properties that depend not only on additives such as microlumens (e.g., glass microspheres) and their fractional volume, but also on interactions with the gel such as the polymeric network and the interfacial parameters (compatibility, wetting capacity and bonding, collectively described in this document as adhesion). Adhesion is important to achieve improvement in composite properties. Adhesion adjustment also increases the additive's physical-chemical suitability to the polymeric network thereby increasing the dispersion of the additive in the network.
    [083] The modification of the additive surface is a path to increase the adhesion between the polymer and the additive. The adhesion forces between the surface-treated additive and the polymer range from strong chemical bonds or electrical attraction to weak van der Waals (VDW) interactions, as well as combinations thereof.
    [084] The surface treatment supports the chemical reaction and / or physical interaction between the lumen and the gel; optionally, the macrolumen can also be treated on the surface. The reaction preferably prevents the gel and the lumen (s) from separating into two phases. Chemical surface treatment is more preferable, as it induces covalent interactions, which stabilize the lumen (s) in the gel and prevent slipping or separation in two phases. Also the
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    19/40 binding of microlumens to the gel causes the gel to surround the microlumens; in the event of rupture or leakage, without limitation to a single hypothesis, it is expected that the gel will continue to cover the microlumens, so that the body would be exposed only to the cohesive gel.
    [085] Without limitation to a closed list, some non-limiting examples of surface treatment are provided below. A type of interaction of silicone polymer (in the silicone gel) and the surface of the microlumens can optionally be obtained through the use of long molecular weight chains anchored on the surface. These chains can favor non-covalent molecular entanglements, with the gel polymer surrounding the microlumen, particularly when the chain is chemically and sterically similar to the polymer. A non-limiting example of such a surface modification is a microlumen treated on the surface with any long-chain fatty acid, such as stearic acid, for example (18-carbon chain length), or any other long organic chain, hydrophobic or hydrophilic molecules depending on the type of interaction favored, which includes, but is not limited to, the polymer brush; and / or polystyrenes and other molecules of the type. The term polymer brush refers to an assembly of polymeric chains that are attached (grafted, anchored) by one end to a surface or interface. Holding the chains too close together forces the chains to be oriented away from the surface to avoid overlap due to the volume exclusion effect.
    [086] Another type of surface treatment is the creation of a charged surface that favors attraction
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    20/40 electrostatic. The forces of attraction between opposing groups
    loaded in surface and on jail polymeric are responsible for this interaction. Such interaction is common in acid-base interactions or bonding in ions. This type in treatment of precise surface in an modification of gel polymer surrounding, for example, the addition of one polyelectrolyte to the silicone gel. [087] Yet another type in treatment in
    surface involves increasing the roughness or physical variability of the microlumens surface, so that parts of the surface protrude outward into the gel and thus can interact with the gel.
    [088] Yet another type of interaction is the chemical bond between the surface and the polymeric matrix molecules obtained by the use of coupling agents. Most cases of surface treatment by organofunctional silanes, zirconates, titanates and other coupling agents result in this type of polymer-surface interaction. The type of coupling agent is selected according to the surface chemistry of the additive, in this case, the chemical composition of the surface of the microlumens and, therefore, the material that is suitable for use with the microlumens.
    [089] Organofunctional silanes are mainly used to improve mechanical properties and to maintain them by protecting the surface from moisture and heat that cause property deterioration. During storage, use and processing of the composite, the surrounding water diffuses through the matrix. This moisture affects the glass's wetting capacity by reducing the surface energy from ~ 500 mJ / m for pure glass to ~ 10 to 20 mJ / m for
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    21/40 wet glass, and promotes corrosion at specific sites on the surface. In order to ensure good wetting of a solid by a liquid, the liquid phase must have a surface energy lower than that of the solid surface. The low value for wet glass is well below that of the polymeric matrix, which results in reduced wetting capacity, increased adhesion failure and enhanced general property deterioration. Thus, the use of glass microlumens without cover is inappropriate for long-term implants; such problems are overcome through the use of functional derivation of the microlumen surface, as described in this document.
    [090] The most common chemical structure of silane is R-S1-X3, where X is an alkoxy group that can hydrolyze to reactive groups on the surface and R is an organofunctional group that can react with the polymeric matrix. There are two main techniques for silane insertion:
    [091] a. Pre-treatment - the direct application of pure silane or its solution in an organic solvent diluted with water that speeds up the reaction, to the additive. This technique is usually completed by spraying or immersing the additive with the silane agent (surface finish).
    [092] b. The addition of silane to the polymer followed by the untreated additive. This technique is used less frequently, but is still covered by at least some
    embodiments of the present invention. of such treatment in [093] The result surface is the formation of a network polysiloxane in multilayer in cross-linked silane thick three-dimensional. THE
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    22/40 silane monolayer, obtained, for example, through the use of vapor phase silylation techniques, can also optionally be used.
    [094] For example, silanes are used to form chemical bonds to the glass surface and can then optionally be used with glass microlumens. The organofunctional group of silane is selected according to the type of interaction that is favorable between the polymer and the additive. The interaction can be of the order of weak VDW forces, hydrophilic-hydrophobic interactions and even chemical covalent bonds. There is a wide variety of possible R groups and the specific species is selected for its affinity to the polymeric matrix. It should be noted that more than one type of silane can be effectively used with a given polymer. Thus, for a specific polymer, the most suitable organofunctional silane coupling agent selected must result in chemical bonding and interdiffusion through the matrix to form the network with the polymer.
    [095] For example, surface treatment with a silane such as n-propyltrimethoxysilane can increase the affinity of the hydrophobic silicone gel to the glass; a non-limiting example of such a silicone gel is a gel with polydimethylsiloxane (PDMS) chains. It can also take part in the chemical reaction that occurs during the gel's curing stage and thus form a better bond with the silicone gel. The humidification angle of a glass surface coated with n-Propyltrimethoxysilane is in the range of 80 degrees and above, compared to the humidification angle of the uncoated glass which is below 20 degrees; as previously mentioned, increased humidification angle leads to increased
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    23/40 of glass / gel interactions and better distribution of microlumens.
    [096] A non-limiting example of a suitable curing mechanism is a platinum-catalyzed addition reaction between silane and glass. It consists of vinyl-substituted PDMS which is cross-linked with hydrogen-substituted PDMS as the crosslinker. Hydrogen substitution means that some silicon atoms in the PDMS chain have a vinyl group instead of a methyl group. The vinyl group is susceptible to binding to a neighboring chain with some PDMS silicon atoms that have a hydride group instead of a methyl group, creating a crosslink. Each silicon hydride group is added via a double vinyl bond (CH2 = CH-), thereby converting the vinyl group to an ethylene bridge (-CH2-CH2-) that connects two polymeric silicone molecules to each other .
    [097] Since at least some of the polymeric silicone molecules are expected to have more than two reactive groups per molecule, but without limitation to a single hypothesis, it is expected that the reaction will result in a reticulated system without the addition of any new ones soluble or drainable components. This healing reaction is known as hydrolyzation and forms a very slightly crosslinked gel that provides the desired softness and complacency or resilience (ie - the desired look and feel of the current fabric). The chemical propyl portion of nPropyltrimethoxysilane can take on the role of the hydrogen-substituted PDMS and act as a crosslinker. Thus, the hydrolyzation cure reaction also occurs in the surface treated microlumens and results in a system
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    24/40 crosslinked without adding any new drainable or soluble components.
    [098] Another possibility is 3Glicidoxypropyltrimethoxysilane which can participate in the chemical reaction that occurs during the curing phase of the gel that results in better bonding to the silicone gel. Epoxy functional silane is less hydrophobic than propyl functional silane, but it is more reactive under the same reaction conditions. Again, the surface treatment can act as a crosslinker.
    [099] Through such chemical cross-linking and other interactions, the gel polymer is accumulated at the polymer / microlumen interface, adsorbed on the surface of the surface treated additive, involves the formation of physical interactions and chemical bonds, denoted as physisorption and chemisorption, respectively. Without limitation to a single hypothesis, it is reasonable to assume that the most strongly attached polymeric chains remain on the surface and that the adsorption is irreversible and permanent, so that the chains initially in contact are retained and adsorbed on the surface, covering the entire microlumen. Thus, even if the implant were to rupture, no direct contact between the tissue and the additive would occur. The surrounding tissue would only come in contact with the outer gel coating layer on the surface of the additive. The microlumen, therefore, would form an intrinsic part of the gel network, acting as a crosslinking site in the network.
    [0100] Additionally, because combination gives physical attraction on the surface and at reactions covalent, without limitation to a only hypothesis, is likely that strength in
    Petition 870180124340, of 08/31/2018, p. 32/53
    25/40 general adhesion between the treated glass surface and the gel is higher than the cohesive strength in the gel. Thus, the failure of the composite material due to the applied external force, such as a physical blow, would result in loss of integrity in the gel and not in the gel-additive interface. This is not true for untreated or improperly treated additives because this failure can occur at the interface, as mentioned above, since the gel / additive combination is a mixture rather than a composite.
    [0101] Also, for a composite material, the mechanical properties such as the modulus of elasticity can be controlled, for example, by being increased above the expected level for untreated or improperly treated microspheres and gel mixing, optionally from at least about twice the elasticity to about ten times the elasticity. There is an increase in certain mechanical properties in such a mixture due to the addition of high modulus microspheres that can mask the harmful effect of microlumens in reducing the continuity of the gel network. On the contrary, there is an additional increase in certain mechanical properties such as the modulus of elasticity due to the fact that the treated microlumens integrate with the polymeric network. As described in more detail below, this effect has been demonstrated experimentally (see Figure 6).
    [0102] Optionally, the additives can be coated with the gel which is then quickly cured, after which the gel / additive combination can optionally be mixed with other materials, including gel, for example.
    GEL MATERIAL [0103] The polymeric gel described above is
    Petition 870180124340, of 08/31/2018, p. 33/53
    26/40 preferably a silicone gel as is known in the art, such as PDMS and derivatives thereof, for example, and / or any other suitable polymeric gel; in the case of implanted composite material, the gel is biocompatible.
    COATING MATERIAL [0104] The implant is preferably encapsulated by a coating, constructed from a material as is known in the art, to contain the composite material described above. A non-limiting example of a suitable coating material is a silicone elastomer, optionally with a material such as polyurethane foam superimposed on the coating.
    [0105] The principles and operation of the present invention can be better understood with reference to the drawings and the accompanying description.
    EXAMPLE 1 - PHYSICAL STRUCTURES OF IMPLANTS [0106] Figures 1 to 5 show several exemplary non-limiting modalities of implants according to the present invention. Any of the coating material modalities described above, gel material and microlumens / macrolumen (s) (or combinations thereof) can optionally be used with the structures described below.
    [0107] Figure 1 shows a non-limiting example of an illustrative encapsulated prosthetic implant according to at least some embodiments of the present invention. As shown, an implantable prosthesis 100 comprises a low penetrable coating 110 which optionally comprises a biocompatible silicone, polyurethane or other material as is commonly used for implants. The coating 110 may comprise a layer
    Petition 870180124340, of 08/31/2018, p. 34/53
    27/40 single or multiple layers, where some layers can be of one material and others, of another. Additionally, coating 110 can be smooth or textured, with various patterns. The variable coating. The coating
    110 may have areas of elasticity
    110 may have a different thickness in different areas.
    Optionally, the coating material 110 can be a combination of several materials. In general, the liner 110 serves as a wrapper to prevent the contents of the prosthesis
    100 leaks.
    Optionally, the coating 110 can be supplied in various formats, for example, round, oval, anatomical, personalized or other.
    [0108] The coating 110 contains a gel 120 and at least one lumen 140. In this non-limiting example, the coating 110 contains a plurality of microlumens 140, which can optionally be flexible or soft, or rigid or hard. Microlumens 140 can optionally, for example, be implanted as hollow microlumens.
    [0109] Figure 2 shows another non-limiting example of an illustrative encapsulated prosthetic implant 200, according to at least some embodiments of the present invention. In this example, coating 100 again contains gel 120; however, the at least one lumen comprises a macrolumen 130 as shown.
    [0110] Figure 3 shows yet another non-limiting example of an illustrative encapsulated prosthetic implant 300, according to at least some embodiments of the present invention. In this example, coating 110 again contains gel 120; however, the at least one lumen comprises a macrolumen 130 as shown, on top of which a
    Petition 870180124340, of 08/31/2018, p. 35/53
    28/40 layer 318, comprising gel 120 mixed with a plurality of microlumens 314. Top preferably means a location closer to the skin.
    [0111] Various other provisions of the 110/210/310 coating and / or other components, which are taught in US Patent Application No. 20090299473, filed on April 24, 2006, the entire amount of which is incorporated herein by way of reference, which has co-ownership in common with the present application and has at least one inventor in common, can also optionally be used, in an additional or alternative way.
    [0112] If the lumen comprises a rigid microlumen or a plurality thereof, such as rigid microspheres, for example, the relative amount of such rigid microlumens is preferably less than 60% in v / v in the gel. For example, since the concentration of microspheres increased by up to 60% in v / v in silicone gel, the gel's firmness increased and the elongation property decreased. Above 60% in v / v of microspheres, the mixture behaves like a paste.
    [0113] To reduce the adverse effect of firmness and lack of flexibility of the resulting gel mixture, different layers of gel with different concentrations of microsphere are preferably provided, more preferably, with an increased concentration of microspheres in a portion of the coating that is the more distant from the skin or that is otherwise less likely to be felt, with decreasing concentrations of microspheres far from that location, and optionally, even a layer with no microspheres. A non-limiting example of
    Petition 870180124340, of 08/31/2018, p. 36/53
    29/40 such a layer arrangement is as follows: 40% by volume of the implant filled with 50% in v / v of microspheres in an internal lumen and the rest of the implant filled with 30% in v / v of microspheres.
    [0114] Figure 4 shows another arrangement of another additional non-limiting example of an illustrative encapsulated prosthetic implant 400, in accordance with at least some embodiments of the present invention. In this example, coating 110 again contains gel 120. In gel 120, there is a first macrolumen 402 as shown, which preferably has a plurality of microlumens mixed with the gel (not shown), surrounded by another coating 404. In the first macrolumen 402 there is preferably a second macrolumen 406 which has only air, as the innermost layer, which is again encapsulated by yet another coating 408. Each of the coatings 110, 404 and 408 can optionally be made of similar or different materials. In addition, any of the modalities mentioned above can optionally be combined with that modality.
    [0115] Figures 5A and 5B show yet another arrangement of yet another non-limiting example of an illustrative encapsulated prosthetic implant 500 according to at least some embodiments of the present invention. Figure 5A shows a partial sectional view of the implant, while Figure 5B shows the entire implant with transparent borders. In this example, an outer sheath 502 contains an outer composite material 504, while an inner sheath 506 contains an inner composite material 508. Each of outer sheath 502 and sheath
    Petition 870180124340, of 08/31/2018, p. 37/53
    Internal 30/40 506 can optionally be constructed of an elastomeric silicone material as described in this document, optionally with a plurality of layers and also optionally with the barrier layer. The outer coating 502 can optionally have either a smooth, non-textured surface; a textured surface; or a surface covered with micro polyurethane foam. Surface texturing has been shown to reduce the incidence and severity of capsular contraction. The inner coating 506 is preferably smooth, but can also optionally be textured.
    [0116] The external composite material 504 preferably has a lower volume / volume percentage of microlumens in a gel, such as glass microspheres, for example, than in the internal composite material 508. Smaller means that the volume / volume percentage ratio of microlumens in the external composite material 504 to that of the internal composite material 508 optionally ranges from 1: 5 to 1: 1. As a non-limiting example, the external composite material 504 can optionally comprise 30% by volume / volume of microspheres while the internal composite material 504 can optionally comprise 50% by volume / volume of microspheres.
    [0117] Each of the outer shell 502 and the inner shell 506 is closed with a plaster made of the same silicone elastomers as the respective shell 502 and 506, and glued using an adhesion component, with the small silicone cap 510 on the inner side of the posterior lumen plaster 512, used for gel filling. The internal coating 506 is located concentrically on the
    Petition 870180124340, of 08/31/2018, p. 38/53
    31/40 external coating 502 and glued to it on a base 514.
    EXAMPLE 2 - SURFACE TREATMENT OF MICROLUMS [0118] This example refers to an illustrative, non-limiting method for treating the surface of microlumens. In this example, the microlumens are assumed to have a glass surface and are treated with a silane, which can optionally be any suitable silane, as described. In terms of the actual materials used to prepare the glass microspheres of Example 3, the hollow borosilicate glass microspheres were coated with npropyltrimethoxysilane. The average size of the microspheres was approximately 60 pm (20 pm to 140 pm) in diameter.
    [0119] Specifically, the glass in the microspheres showed 1% sodium; 2% boron; 96.5% silica; and 0.5% of trace (mainly calcium oxide, and other common earth oxides).
    [0120] The gas mixture inside the microspheres was composed of approximately: 55% nitrogen; 37% carbon dioxide; 7.6% oxygen; and 0.4% argon. The pressure of the gas mixture in the microspheres is 50.66 kPa (0.5 atm). Of course, other gas mixtures can be used as an alternative.
    [0121] At used microspheres in way feature resist pressures above 2.07 MPa (300 psi) (> 20 ATM (2,026 kPa) ) without breaking or collapsing as a
    non-limiting, but preferred example.
    [0122] The microspheres were subjected to a procedure similar to those described below to treat and derive the glass surface.
    PROCEDURE FOR SURFACE TREATMENT OF
    Petition 870180124340, of 08/31/2018, p. 39/53
    32/40
    SILANO
    1. PREPARATION FOR GLASS CLEANING SOLUTION:
    [0123] - 35 ml of saturated solution of potassium dichromate (K2Cr207) is added slowly to 1l of concentrated sulfuric acid solution (H2SO4) in a temperature controlled environment due to a highly exothermic response. The entire sulfochromic solution is stirred for approximately 15 minutes in which a brownish solution appears. The use of fresh solution is recommended for each cleaning procedure.
    [0124] - The piranha solution is used to clean organic waste from the glass and make it more hydrophilic by hydroxylating the surface, thus increasing the number of silanol groups on the surface. The traditional piranha solution is a mixture of 3: 1 sulfuric acid (H2SO4) and 30% hydrogen peroxide (H2O2). Other ratios were used ranging from 1: 1 to 7: 1. The solution can be mixed before application or directly applied to the glass, applying sulfuric acid first, followed by hydrogen peroxide. H2O2 is added very slowly to H2SO4. The solution should begin to bubble vigorously and heat up due to the highly exothermic response. Due to the self-decomposition of hydrogen peroxide, the piranha solution should be used when freshly prepared.
    2. GLASS CLEANING:
    [0125] The glass microspheres are placed and left in the sulfochromic cleaning solution for a period of 1.5 hours. Subsequently, the glass microspheres are rinsed for 5 minutes in distilled water twice and subsequently twice in methanol to remove excess
    Petition 870180124340, of 08/31/2018, p. 40/53
    33/40 of the cleaning solution. The glass is air-dried.
    [0126] The glass is placed and left in the piranha cleaning solution for a period of 10 minutes. Subsequently, the glass microspheres are rinsed for 5 minutes in distilled water twice to remove excess cleaning solution. The glass is air-dried.
    3. PREPARATION OF SILANO TREATMENT SOLUTION (2% SILANO IN TOTAL VOLUME):
    [0127] 93.25% by volume of methanol are mixed with 3.93% by volume of distilled water. 0.81% by volume of acetic acid is added to the solution buffer at a pH of 4.5 to 5.5. 2% by volume of the functional silane is added to the solution.
    4. TREATMENT OF SILANO:
    [0128] The solution is stirred for 10 minutes and during that time, silanol groups are formed in the solution. The clean glass is introduced into the solution for approximately 5 minutes. Then, the glass is rinsed twice in pure methanol and inserted in a 105 ° C oven for 10 minutes to cure and finish the procedure to form the silane layer.
    EXAMPLE 3 - PREPARATION OF AN EXAMPLE IMPLANT [0129] This illustrative example refers to a method of preparing an implant, according to at least some embodiments of the present invention. For description purposes only and without the desire to be limited, the process refers to the preparation of an implant according to Figure 5 above, which has an external compartment with 30% by volume / volume of microspheres / gel and a internal compartment with 50% by volume / volume of microspheres / gel. The microspheres
    Petition 870180124340, of 08/31/2018, p. 41/53
    34/40 used are those described in Example 2 above, which have undergone surface treatment as described above. In the procedure described below, 390 cm 3 in implant volume with a posterior lumen of 175 cm 3 in volume and an anterior lumen of 215 cm 3 in volume is addressed as an example.
    [0130] The implant features a plurality of standard silicone linings that are currently used in the breast implant industry. In this example, the coatings were MED-6640 (NuSil Technology), with a barrier layer - MED-6600 (NuSil Technology) that has PDMS derived from phenyl.
    [0131] The adhesion between the coating and plaster was provided with MED-4750 (NuSil Technology); the plaster seals the opening to the lining and in this example, it has a septum to allow the lining to fill.
    [0132] The filling material was a mixture of an unrestricted degree of silicone gel used in the breast implant industry (MED3-6300 (NuSil Technology)) and especially, custom hollow glass microspheres, prepared as described in Example 2 of hollow borosilicate glass microspheres coated with npropyltrimethoxysilane.
    [0133] For preparing the posterior / anterior (internal / external) lumens, the amounts of microspheres below and Part A and Part B of Silicon were used, as shown in Tables 1 and 2.
    TABLE 1: COMPOSITION DISPERSION, FURTHER, 175 CM3 Compo Count Cont Preci
    Petition 870180124340, of 08/31/2018, p. 42/53
    35/40
    nente wet (% in v) ee (grass) are (± gram) Silic 37.5 63.6 0.01 one, Part A6Silic 12.5 21.2 0.01 one, Part B2Micro 50 14.0 0.01 spheres0
    TABLE 2: DISPERSION COMPOSITION, PREVIOUS, 215
    CM 3
    ponent With Countwet (% in v) Cont are Preci(± gram) ee (grass) icon,THE SilPart 52.5 1 78.20.01 icon,B SilPart 17.5 7 26.00.01 Micspheres 30 2 10.30.01
    [0134] The silicone gel is composed of a two-part kit in a two-component system that cross-links only under mixing (for example, one part will have the polymer with hydride functionality and the other will have the polymer with vinyl functionality) . The two parts, A and B, are mixed in 3: 1 by weight, respectively.
    [0135] 50% v / v dispersion of microspheres (posterior) were prepared as follows. In a 200 cm 3 glass beaker, the following chemicals were added:
    [0136] - 63.66 grams of MED3-6300, Part A.
    Petition 870180124340, of 08/31/2018, p. 43/53
    36/40 [0137] - 21.22 grams of MED3-6300, Part B.
    [0138] All components were mixed by complete magnetic stirring until a homogeneous solution was obtained. The obtained solution was sonicated for 4 to 8 minutes in a bath sonicator to increase the efficiency of the mixture, to avoid agglomeration and to degass the solution. During sonication, the solution was mixed. The obtained solution was degassed using a desiccant vessel with a vacuum of less than 10 KPa (0.01 bar).
    [0139] The amount of 14 grams of microspheres was dried in an oven at 150 ° C for 20 to 30 minutes. During the drying operation, the microspheres were periodically stirred.
    [0140] The dried microspheres were added to the silicone solution immediately after drying. Drying the microspheres immediately before use helps to reduce any moisture on the surface of the microspheres and allows the microsphere / gel interface to have the most complete contact possible with the surface of the microspheres. All components were mixed by magnetic stirring completely until a homogeneous solution was obtained.
    [0141] The resulting solution was sonicated to increase the efficiency of the mixture, avoiding agglomeration and degassing the solution. During sonication, the solution was mixed.
    [0142] THE resulting solution was degassed under less vacuum of that 10 kPa (0.01 bar). [0143] THE amount 30% in v / v in dispersal in microspheres (previous) was prepared in way
    similar, except that a composition of
    Petition 870180124340, of 08/31/2018, p. 44/53
    37/40 different silicone was used as follows, to adjust to the lower percentage of microspheres:
    [0144] - 78.21 grams of MED3-6300, Part A.
    [0145] - 26.07 grams of MED3-6300, Part B.
    [0146] In addition, only 10.32 grams of microspheres were used to obtain the lower percentage of microspheres in the final composite material.
    [0147] Each of the above composite materials was then immediately filled in their respective coatings (lumens). The posterior lumen was prepared with a 175 cm 3 sealed coating (coating and plaster part) and was filled with the 50% v / v dispersion of microspheres described above using a syringe. The excess air in the coating was then removed with a syringe. The sonication and degassing of the solution in the filled liner was performed to allow more air to be removed.
    [0148] The filled lumen was then placed in an oven and rotated along a geometry axis for about ~ 2 rpm during curing at 150 ° C for 5 hours. For this example, a skewer was used to allow rotation of the lumen fixed on the surface. The delay between filling and curing was avoided to prevent phase separation.
    [0149] The anterior lumen was prepared in a similar manner, except that a 390 cm3 open coating (coating without a complete external plaster, with access to the inside) was used. The posterior lumen cured by gel was fixed to the anterior lumen in the center of the radial geometric axes of the anterior lumen so that the two lumens were concentric. The anterior lumen was filled
    Petition 870180124340, of 08/31/2018, p. 45/53
    38/40 with the 30% v / v dispersion of microspheres using a syringe and the process was performed as described for the posterior lumen, which includes curing.
    [0150] Test quantities of the gel containing 30% and 50% of microspheres were cured (outside the coating) and were tested for the storage module (G ') as an indication of cohesion and elastic module, through the performance of a simple dynamic (sinusoidal) shear flow experiment in which a small cyclic strain is imposed under the sample and the stress response is measured.
    Viscoelastic properties (ie storage module (G ') and loss module (G)) are determined using this type of dynamic test. The storage module (G ') is indicative of the resistance of the elastic module and therefore, gel cohesion.
    Figure 6 shows the results of such tests, in which the lowest line (diamonds) refers to the gel alone, without microspheres; the middle line (squares) shows the gel with 30% microspheres; and the top line (triangles) shows the gel with 50% microspheres. As shown, as the percentage of microspheres increases, the composite gel / microsphere material shows the increasing storage module. Such increased resistance also increases the likelihood of the composite material maintaining its coherence if trauma occurs (such as a physical blow to the material, or to the tissue containing the material) and also means that the gel / microsphere bond is stronger than the gel / microsphere bond. gel, so that even if the composite material is cleaved, the surrounding tissue will be protected from exposure of the microspheres by itself.
    [0151] Although the invention has been described in
    Petition 870180124340, of 08/31/2018, p. 46/53
    39/40 in relation to a limited number of modalities, it must be realized that the optimal dimensional relationships for the parts of the invention, to include variations in size, materials, shape, shape, function and manner of operation, assembly and use, are readily considered apparent and obvious to elements skilled in the art, and all relationships equivalent to those illustrated in the drawings and those described in the specification are intended to be encompassed by the present invention.
    [0152] Thus, the precedent is considered only as an illustrative form of the principles of the invention. Furthermore, since numerous modifications and alterations will readily occur to elements skilled in the art, it has not been described to limit the invention to the exact
    construction and operation shown and described, and consequently, all modifications appropriate and equivalents can appeal To to fit in in scope gives invention. [0153] By having described an modality preferential specific to invention with reference to attached drawings, it will be appreciated that the gift invention no
    it is limited to such precise modality and that several changes and modifications can be made to it by elements versed in the technique, without departing from the scope and spirit of the invention defined by the attached claims.
    [0154] Additional modifications of the invention will also occur to elements skilled in the art and they are considered to fit the spirit and scope of the invention, as defined in the attached claims.
    [0155] Although the invention has been described in
    Petition 870180124340, of 08/31/2018, p. 47/53
    In relation to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention can be made.
    权利要求:
    Claims (12)
    [1]
    1. SUITABLE COMPOSITE MATERIAL FOR IMPLANTATION FOR THE
    HUMAN BODY, characterized by understanding:
    (i) a polymeric gel and microlumens treated with fatty acids; or (ii) in which the composite is obtained by mixing surface-treated microlumens with a polymeric gel and wherein said polymeric gel comprises a reactive cross-linking group for cross-linking to said microlumens; and in which surface-treated microlumens are obtained by surface treatment with organofunctional silanes, titanates and zirconates.
    [2]
    2. COMPOSITE MATERIAL, according to claim 1, characterized in that said microlumens are constructed of ceramic, plastic, glass, PMMA (polymethylmethacrylate), polyacrylonitrile, polybutadiene, natural or synthetic rubber.
    [3]
    3. COMPOSITE MATERIAL according to claim 1 or 2, characterized in that said polymeric gel comprises a silicone gel.
    [4]
    4. COMPOSITE MATERIAL according to any one of claims 1 to 3, characterized in that said organofunctional silanes include n-propyltrimethoxysilane.
    [5]
    5. PROSTHETIC IMPLANT, suitable for implantation into the human body, characterized in that it comprises a coating and the composite material, as defined in any one of claims 1 to 4.
    [6]
    6. IMPLANT according to claim 5, characterized in that it comprises a plurality of coatings, including at least one internal coating and at least one
    Petition 870190002638, of 01/09/2019, p. 5/9
    2/3 external coating.
    [7]
    7. IMPLANT according to claim 6, characterized in that said at least one internal coating is partially surrounded by said external coating, wherein said external coating is filled with said composite material which has a first percentage of microlumens and in which said inner lining is filled with said composite material which has a second percentage of microlumens, wherein said first and second percentages are different.
    [8]
    8. IMPLANT according to claim 7, characterized by a ratio between said first and second percentages being in the range of 1: 1 to 1: 5.
    [9]
    9. IMPLANT, according to claim 8, characterized in that said first percentage is 30% in volume / volume and in which said second percentage is 50% in volume / volume.
    [10]
    10. PROSTHETIC IMPLANT, according to any one of claims 5 to 9, characterized in that the composite is obtained by mixing surface-treated microlumens with a polymeric gel and wherein said polymeric gel comprises a reactive cross-linking group for cross-linking to said microlumens; and where the surface-treated microlumens are obtained by a surface treatment by organofunctional silanes, titanates and zirconates;
    wherein the crosslinking of said microlúments to the crosslinking groups causes the gel to surround the microlumens; and if the implant is broken, the gel will continue to cover the microlumens, such that the body would only be
    Petition 870190002638, of 01/09/2019, p. 6/9
    3/3 exposed to said gel.
    [11]
    11. METHOD FOR MANUFACTURING IMPLANTS, as defined in any one of claims 5 to 10, characterized by:
    i. mixing a polymeric gel and a plurality of additives to form a composite material, wherein said additives comprise a plurality of surface treated microlumens with fatty acids; or ii. surface treated microlumens with organofunctional silanes, titanates and zirconates;
    mixing the surface-treated microlumens with a polymeric gel to form a composite material, wherein said polymeric gel comprises a reactive crosslinking group for crosslinking to said microlumens; and encapsulating the composite material of i. or ii. inside a coating.
    [12]
    METHOD, according to claim 11, characterized in that it comprises dispensing said microlumens in said gel by rotating said coating during curing.
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    同族专利:
    公开号 | 公开日
    WO2011086537A3|2011-09-22|
    US9775703B2|2017-10-03|
    RU2583888C9|2016-08-27|
    US20180036116A1|2018-02-08|
    ES2691279T3|2018-11-26|
    IL220915A|2015-03-31|
    WO2011086537A2|2011-07-21|
    RU2012132949A|2014-02-27|
    TR201815113T4|2018-11-21|
    US10213293B2|2019-02-26|
    LT2525839T|2018-11-12|
    KR101925152B1|2018-12-04|
    PL2525839T3|2019-02-28|
    MX2012008200A|2012-11-06|
    CN203107780U|2013-08-07|
    MX353561B|2018-01-17|
    RU2583888C2|2016-05-10|
    US20120277860A1|2012-11-01|
    US20160175486A1|2016-06-23|
    CA2786279C|2018-02-20|
    US9339371B2|2016-05-17|
    BR112012017536A2|2018-06-05|
    EP2525839A2|2012-11-28|
    KR20120123093A|2012-11-07|
    CA2786279A1|2011-07-21|
    EP2525839B1|2018-07-18|
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    法律状态:
    2018-06-19| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2018-07-10| B06T| Formal requirements before examination|
    2018-10-16| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|
    2019-02-05| B09A| Decision: intention to grant|
    2019-04-09| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 18/01/2011, OBSERVADAS AS CONDICOES LEGAIS. (CO) 20 (VINTE) ANOS CONTADOS A PARTIR DE 18/01/2011, OBSERVADAS AS CONDICOES LEGAIS |
    优先权:
    申请号 | 申请日 | 专利标题
    US29578810P| true| 2010-01-18|2010-01-18|
    US61/295,788|2010-01-18|
    PCT/IB2011/050217|WO2011086537A2|2010-01-18|2011-01-18|Lightweight breast implant material|
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