WO2013048978A1 - Implant en silicone texturé - Google Patents

Implant en silicone texturé Download PDF

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Publication number
WO2013048978A1
WO2013048978A1 PCT/US2012/056984 US2012056984W WO2013048978A1 WO 2013048978 A1 WO2013048978 A1 WO 2013048978A1 US 2012056984 W US2012056984 W US 2012056984W WO 2013048978 A1 WO2013048978 A1 WO 2013048978A1
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WO
WIPO (PCT)
Prior art keywords
silicone
sock
mesh
implant
poly
Prior art date
Application number
PCT/US2012/056984
Other languages
English (en)
Inventor
Nicholas J. Manesis
Futian Liu
Original Assignee
Allergan, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/245,518 external-priority patent/US20120041555A1/en
Application filed by Allergan, Inc. filed Critical Allergan, Inc.
Priority to AU2012316320A priority Critical patent/AU2012316320A1/en
Priority to CA2850132A priority patent/CA2850132A1/fr
Priority to EP12769851.2A priority patent/EP2760491A1/fr
Publication of WO2013048978A1 publication Critical patent/WO2013048978A1/fr

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Classifications

    • 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
    • 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
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/08—Methods for forming porous structures using a negative form which is filled and then removed by pyrolysis or dissolution
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
    • 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
    • A61L2420/00—Materials or methods for coatings medical devices
    • A61L2420/02—Methods for coating medical devices
    • 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
    • A61L2430/04—Materials or treatment for tissue regeneration for mammary reconstruction

Definitions

  • a natural part of that healing process includes the formation of a capsule surrounding the implant.
  • the capsule is formed when fibroblasts, fibrous cells, grow around the surface of the implant, forming a tissue layer similar to scar tissue. Over time, the body naturally shrinks this capsule tissue. Although part of the healing process, complications may arise when the capsule tissue shrinks, known as capsule contracture. In particular, the capsule tissue may tighten around the implant deforming it, and possibly causing patient pain or discomfort.
  • Such complications are particularly problematic in the case of breast implants.
  • Such implants which may be introduced into a patient's body during cosmetic or reconstructive surgery, are typically constructed of silicone (a flexible material) and are designed to provide a natural shape, appearance, and feel. Capsule contracture may significantly alter the properties of the implant, however, compressing the implant and altering its appearance, and possibly causing significant discomfort. Accordingly, some example embodiments provide improved implants and processes for making implants which may reduce the severity and likelihood of complications arising from capsule contracture.
  • Some embodiments described herein provide procedures for making an implant having a textured silicone surface. Such example procedures may include forming a component having a silicone surface; pressing a plurality of polymer fibers at least partially into the silicone surface, before the silicone has completely cured; allowing the silicone to at least partially cure with the polymer fibers in the silicone surface; and after the silicone is at least partially cured, removing the polymer fibers from the silicone surface.
  • Some example procedures may also include forming a mesh from the polymer fibers before pressing the polymer fibers at least partially into the silicone surface. In some example embodiments, forming the mesh may further include weaving the polymer fibers in a repeating pattern. In some example embodiments, the mesh may be made of a plurality of layers. And in some example procedures the mesh may include a plurality of eyes having an average size between about 100 m x 100 ⁇ to about 2000 ⁇ x 2000 ⁇ .
  • Some example procedures may also include forming a felt from the polymer fibers before pressing the polymer fibers at least partially into the silicone surface.
  • the polymer fibers may be made of at least one of Vicryl 910, poly (L-lactic acid-co-trimethylcarbonate), polycaprolactone, poly(methyl methacrylate), poly(L-lactic acid), poly(lactic-co-glycolic acid) or combinations thereof.
  • removing the polymer fibers may include dissolving the polymer fibers in a solvent.
  • the polymer fibers may not be soluble in at least one of xylene and toluene; but the polymer fibers may be soluble in at least one other organic solvent.
  • the organic solvent may be one of methylene chloride, chloroform, acetone, and tetrahydrofuran.
  • removing the polymer fibers may further include removing the polymer fibers by hydrolytic degradation.
  • the polymer fibers themselves may have an average thickness between about 100 ⁇ and about 1000 ⁇ .
  • Some example embodiments provide silicone medical devices produced according to any of the procedures disclosed in the present application. Such medical devices may be breast implants.
  • breast implants which may include a silicone shell having an inner surface, defining a cavity configured to be filled with a filler material, and an outer surface, the outer surface having a texture comprised of a plurality of protrusions and a plurality of interconnected recessed areas.
  • the texture may be an imprint of a plurality of polymer fibers pressed into the outer surface of the silicone shell before the silicone shell is completely cured and removed after the silicone shell has at least partially cured.
  • the imprint may be of a mesh woven from the polymer fibers.
  • the imprint may be of a felt formed from the polymer fibers.
  • the average vertical distance between a high point of a protrusion, in the plurality of protrusions, and a low point of recessed area, in the plurality of recessed areas may be between about 100 ⁇ and about 1000 ⁇ .
  • the texture may include a plurality of tunnels.
  • a medical devices which may include a silicone outer surface having a plurality of projections and a plurality of interconnected recessed areas, the average vertical distance between a high point of a protrusion, in the plurality of protrusions, and a low point of a recessed area, in the plurality of recessed areas, being between about 100 ⁇ and about 1000 ⁇ .
  • the recessed areas may include channels with an average diameter between about 100 ⁇ and about 1000 ⁇ .
  • At least some of the recessed areas may be smooth. In others at least some of the recessed areas may be textured.
  • methods of making a textured component of a breast implant shell are provided.
  • the methods generally comprise the steps of
  • the methods further generally comprise the steps of at least partially curing the silicone dispersion with the sock in contact therewith to form a silicone elastomer, and, after the silicone is at least partially cured, removing the sock from the silicone elastomer to form a textured component of a breast implant shell.
  • One or more additional polymeric mesh socks may be applied to the mandrel to create other, different textures.
  • the step of contacting the sock with the silicone dispersion may be performed after the step of applying the sock to the mandrel. In other embodiments, the step of contacting the sock with the silicone dispersion is performed before the step of applying the sock to the mandrel.
  • the polymeric mesh sock may be comprised of any suitable material that can be dissolved or otherwise removed from the cured silicone elastomer without substantially effecting the structure of the silicone elastomer.
  • the sock comprises a mesh made of at least one of Vicryl 910, poly (L-lactic acid-co- trimethylcarbonate), polycaprolactone, poly(L-lactic acid), poly(methyl methacrylate) and poly(lactic-co-glycolic acid).
  • the polymeric mesh sock comprises a mesh including a plurality of eyes having an average size between about 100 pm x 100 ⁇ to about 2000 ⁇ x 2000 ⁇ .
  • Tthe step of removing the sock from the silicone elastomer comprises contacting the sock with an organic solvent selected from methylene chloride, chloroform, acetone, tetrahydrofuran and combinations thereof.
  • the present invention further provides breast implant shells or components thereof, made by the processes and methods described herein.
  • FIG. 1 illustrates a procedure, in accordance with an example embodiment.
  • FIG. 2 illustrates an example polymer mesh in accordance with an example embodiment.
  • FIG. 3 illustrates an example breast implant in accordance with an example embodiment.
  • FIG. 4 illustrates a close-up, top-down view of an example textured surface.
  • FIG. 5 illustrates a close-up, side view of an example textured surface.
  • FIG. 6 illustrates a close-up, top-down view of an example textured surface.
  • FIG. 7 illustrates a close-up, side view of an example textured surface.
  • FIG. 8A is an optical microscopic image of a silicone texture with mesh over it.
  • FIG. 8B is an optical microscopic image of the silicone texture with mesh removed.
  • FIG. 8C is a scanning electron microscope (SEM) image of the silicone texture.
  • FIG. 9A is an optical microscopic image of a silicone texture with mesh over it.
  • FIG. 9B is an optical microscopic image of the silicone texture with mesh removed.
  • FIG. 9C is an SEM image of the silicone texture.
  • FIG. 10A is an optical microscopic image of an exemplary mesh.
  • FIG. 10B is an SEM image of a silicone texture after the mesh is removed.
  • FIG. 1 1 A is an optical microscopic image of a silicone texture imprinted by multiple mesh layers.
  • FIG. 1 1 B is an SEM image of the same.
  • FIG. 12A is an SEM image of a silicone texture imprinted by multiple polycaprolactone mesh layers.
  • FIG. 12B is a cross sectional view of the same.
  • FIGS. 13A - 13C are perspective views illustrating steps useful in accordance with certain methods of the present invention which include the provision of a three-dimensional mesh sock to thereby form a textured surface in a breast implant shell.
  • FIG. 14 shows images of silicone materials made in accordance with different embodiments of the invention.
  • Figs. 15A - 15D are optical microscopic images and SEM images of a silicone material made in accordance with a method of the invention.
  • Figs. 16A - 16D are optical microscopic images and SEM images of another silicone material made in accordance with a method of the invention.
  • Figs. 17A - 17B are SEM images of yet another silicone material made in accordance with a method of the invention.
  • Figs. 18A - 18B are SEM images of a further silicone material made in accordance with a method of the invention.
  • a number of medical and cosmetic procedures involve the implantation of devices and other objects constructed entirely or partially of silicone, e.g. implants used in breast augmentation and reconstruction procedures, pacemakers, heart valves, artificial joints, etc.
  • medical implants can be made of material such as plastic, metal, etc. and at least a portion of the implant coated with silicone as described herein.
  • implants made of silicone may be safely implanted in the human body, such implants suffer from a number of problems.
  • silicone implants may suffer from a condition known as capsule contracture.
  • breast implants or any other objects whether constructed of silicone or another material, are implanted in a patient's body, the body naturally forms a lining surrounding the implant.
  • the formation of this lining, or capsule, is a natural response to the introduction of a foreign object, and the fibrous tissue which forms is similar to scar tissue.
  • the formation of this capsule may lead to significant complications.
  • the body may shrink the fibrous tissue that makes up the capsule, causing the capsule to tighten around the implant.
  • this tightening may be significant, altering the implant's shape, appearance, and feel.
  • the implant may appear to become firmer or harder and may take on a compressed or deformed shape.
  • capsule contracture may cause problems beyond aesthetic considerations. In some cases, capsule contracture may cause significant pain and discomfort to the patient.
  • example embodiments may provide implants designed to prevent complications due to capsule contracture, and procedures for the manufacture of such implants.
  • some example embodiments may relate to breast implants which may include a silicone shell textured to deter such complications.
  • implants having an external surface texture as opposed to a traditional smooth surface. This is because, the fibroblasts, cells which grow to form the fibrous tissue of the capsule, easily adopt a planar configuration on a flat, smooth surface.
  • planar configurations are particularly subject to capsule contracture, and, accordingly, implants which employ a smooth outer shell experience increased rates of problematic contracture.
  • textured surfaces may prevent the fibroblasts from forming a planar configuration. Accordingly, in order to prevent the problems associated with contracture, some breast implants, therefore, provide textured external surfaces. For instance, some breast implants have been manufactured which are coated in a polyurethane foam. Such textured surfaces, however, are not ideal as the surface pits which make up the texture are largely isolated from one another, in turn isolating the fibroblasts, and hindering their penetration into the recessed areas of the surface.
  • Example embodiments described herein provide implants, and procedures for making implants, with interconnected surface pores.
  • surface textures are provided with features, e.g. pores and protrusions, which measure in the hundreds of micrometers. Such features are much larger than the cells which form the capsule surrounding the implant. Accordingly, the cells are able to infiltrate the pores of the textured surface, interrupting the formation of a planar capsule configuration. The resulting capsule which does form may be thinner and may be less subject to complicating contracture.
  • example embodiments may also provide textures with interconnections between the pores formed on the surface. Such interconnections may facilitate the infiltration of cells into the pores furthering the disruption of the planar configuration.
  • interconnections may allow cells to penetrate deep within the surface of the implant by creating an environment in which those penetrating cells are able to easily exchange nutrients and waste.
  • the cells of the capsule may penetrate deeper into the features of the surface than possible in traditional implants.
  • the interconnected nature of the texture may encourage tissue adhesion to the implant, which may prevent the implant from shifting.
  • some example embodiments may provide procedures for making implants comprising at least a portion coated or formed of silicone with textures such as those described above. It is noted that, in the description that follows, example embodiments are described with reference to silicone breast implants. It is to be understood that the scope is not so limited, and other example embodiments apply to other types of implants or devices and to other materials.
  • example procedures may be used to form other implantable silicone devices, and components of such devices, e.g. pacemakers, artificial joint implants, implants for use in surgical reconstructive surgery, heart valves, coverings for implanted devices, insulation for implanted electrical elements such as pacemaker leads, graft points for implantable devices, etc.
  • example procedures may be used to create other silicone devices for medical or non-medical purposes, e.g. balloon catheters, tubing, ear plugs and hearing aids, etc.
  • some example embodiments may be used in the creation of devices made of other materials such as, but not limited to plastic or metal coated at least partially coated with silicone.
  • strand and filament refer to a single, unitary, elongated structure.
  • fiber may refer to either a single strand or filament, or to multiple strands or filaments that are braided, coiled, twisted, or otherwise formed into an elongated structure.
  • example embodiments may provide processes for creating a silicone shell of a breast implant with a textured outer surface, by imprinting a texture using an assemblage of polymer fibers, e.g. a woven cloth, a tangle, a felt, an attached or unattached mesh, or any other structure formed of fibers.
  • example embodiments may provide a process in which an assemblage of polymer fibers is impressed into an uncured, or partially cured silicone surface.
  • the silicone may be allowed to cure either fully or partially, after which the fibers may be removed, leaving an imprint of the fibers as a texture on the silicone surface (the silicone need only cure enough to maintain the imprinted structure when the fibers are removed).
  • Such example processes may be capable of providing silicone implants with desirable surface textures without sacrificing the mechanical properties of the silicone, e.g., the hardness, tensile strength, elongation, tear strength, and abrasion resistance of the material.
  • an assemblage of polymer fibers may be formed which will be used to imprint a texture on a silicone surface of an implant.
  • the fibers may be constructed of any material with suitable mechanical strength and flexibility.
  • the polymer employed may need to be relatively insoluble in either xylene or toluene, but may be soluble in other organic solvents such as methylene chloride and chloroform.
  • biodegradable materials such as Vicryl 910, poly (L-lactic acid-co-trimethylcarbonate), polycaprolactone, poly(methyl methacrylate), poly(L-lactic acid), poly(lactic-co-glycolic acid), and the like, may be used to construct the assemblage of polymer fibers. It is noted that the materials listed above as example materials have all been approved by the FDA for use in therapeutic applications.
  • degradable polymers that can be used to form the fibers include, but are not limited to poly(ethylene-vinyl acetate), poly(hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D, L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-esters) (e.g. PEO/PLA), polyalkylene oxalates, polyphosphazenes and biomolecules such as fibrin, fibrinogen, cellulose, starch, collagen and hyaluronic acid or combinations thereof.
  • Such materials may be capable of forming fibers of sufficient strength and may be easily removed from the cured (or partially cured) silicone, e.g., by dissolution in an appropriate solvent or through hydrolytic degradation. Any other materials which may be removed from silicone through a process which does not damage the silicone surface may be used as well. For instance, other materials which are soluble, or otherwise removable, by a substance which does not significantly affect silicone may be used. Materials with melting or sublimation points below that of silicone, or which are otherwise weakened by the application of heat, may also be used. In such cases, the removal process may include heating the silicone surface to a temperature at which the mesh may be removed from the surface. Materials which degrade through other processes may also be used.
  • the assemblage itself may be formed from the polymer fibers in any reasonable manner.
  • one or more polymer fibers may be woven or knit together to form a mesh.
  • fibers may be bundled together and pressed to form a felt or mat structure.
  • fibers may be twisted together before being formed into a mesh, felt, or other structure. Any other combination of fibers may also be used, whether having an intentional structure, or a structure randomly formed.
  • the fibers need not be formed into an assemblage before use. Rather, in some example embodiments, individual fibers may be deposited onto a silicone surface which is to be imprinted (either randomly or according to some pattern).
  • an example mesh is illustrated in FIG. 2.
  • the mesh 200 may be woven into a pattern.
  • the woven mesh 200 may have the form of any traditional woven material.
  • a fiber 201 may be linked together with itself or other fibers to create a mesh 200.
  • fibers 201 in the weave may overlap one another.
  • open spaces (or eyes) 202 may exist between the fibers 201 of the mesh 200.
  • These structures may naturally form a texture of interconnected pores when imprinted in a silicone surface. For instance, where the fibers 201 overlap the thickness of the mesh 200 may be the greatest, ultimately resulting in a pore formed in the imprinted surface.
  • pores may be interconnected, as the fibers 201 that make up the woven mesh may continue beyond each area of overlap.
  • the mesh is open, it will not displace the silicone material, and, therefore, a protrusion may be formed on the surface.
  • other fiber structures e.g. a felt or mat structure, may also be used, as described above.
  • a single polymer filament may form each fiber 201 of the mesh 200 (or other kind of assemblage).
  • the silicone texture which may arise from the mesh 200 may have a smooth channel structure. This channel structure may encourage the growth of fibroblasts within the channels and pores by facilitating the transport of nutrients and waste products into and out of the features of the texture.
  • multiple filaments may be used to form each fiber 201 of the mesh 200. Such embodiments may result in channels having a thread pattern imprinted in the silicone surface of the channel. These thread patterns may facilitate cell attachment.
  • single filament and multiple filament fibers may be used in combination to provide the desired properties.
  • some of the resulting channels formed in the silicone may contain thread patterns while other channels may be smooth.
  • some example meshes, or other fiber structures may be formed using two or more fibers 201 of different widths, compositions, or other properties, which may be woven or otherwise formed together.
  • the mesh 200 may be strengthened before use.
  • the fibers 201 may be woven together into a formed mesh 200, or other structure, the fibers 201 may be joined together, e.g. through the application of heat, pressure, etc., fixing the fibers together.
  • an adhesive may be applied which may cause the fibers 201 to adhere to each other.
  • the mesh 200 may be strengthened and the pattern of the mesh 200 may be made resilient.
  • contact between fibers 201 of the mesh may be important to the removal process, and may be encouraged through application of heat, pressure, adhesive, etc.
  • the physical properties of the mesh 200 itself, or other assemblage of fibers affect the texture that is ultimately formed in the surface, e.g. the pattern of the mesh 200, the thickness of the polymer fibers 201 , the size of the eyes in the mesh 202, etc. These characteristics may be chosen as appropriate for the intended application. For instance, the average thickness of the fibers 201 may be between 100 and 1000 ⁇ . This thickness refers to the diameter of each fiber 201 of the mesh 200, or other assemblage.
  • the average size of the eyes 202, appearing in the mesh may also be chosen. For instance, on average the eyes 202 appearing in the mesh 200 may have a size in the range of approximately 100 x 100 m to 2000 x 2000 ⁇ .
  • the eyes 202 may have any reasonable shape, and the sizes suggested represent areas rather than dimensions of the boundaries of the eyes 202. It is also noted that not all of the eyes 202 need to have the same size. Rather, the pattern of the mesh 200 may form eyes 202 of differing sizes. Other characteristics of the mesh of other assemblage may also be chosen.
  • multiple layers of mesh 200 may be joined together to form a single mesh 200 or structure used to imprint a silicon surface.
  • a mesh 200 may be formed which is itself formed of two or more polymer meshes 200 stacked together.
  • the layers may employ the same mesh pattern and other characteristics, or different mesh 200 layers may have different properties.
  • Further different combinations of fiber structures may be used.
  • a woven mesh structure may be layered with a felt layer, or two felt layers may be used, etc.
  • the final assemblage may be formed through a strengthening process.
  • layers of mesh 200 may be stacked together, and together be subjected to a strengthening process (e.g. the application of heat, pressure, adhesive, etc.), interconnecting the meshes 200, to form a single final structure.
  • a silicone shell, or a portion of the shell (e.g. one half of the final shell) or a silicone coating may be formed from uncured or partially cured silicone.
  • any other object which will be imprinted may also be formed at this point. Any traditional process, e.g. a molding process, may be used to form the silicone into an appropriate shape for the implant.
  • the entire silicone object need not be constructed at once.
  • the shell, or other silicone surface may be constructed in layers, e.g. a silicone layer may be formed and allowed to at least partially cure, after which another layer of silicone material may be applied, etc. In such a case, less than the total number of layers may be imprinted.
  • an assemblage of fibers may be pressed into the surface of the silicone (or individual fibers may be deposited on and pressed into the surface).
  • the assemblage may be placed onto the silicone surface, in a location on the surface that is to be imprinted with a texture. Because the silicone is uncured or partially cured, the fibers may penetrate into the silicone layer.
  • external pressure may be applied tending to push the fibers into the silicone layer.
  • a mechanical press may be used to force the fibers into the uncured or partially cured silicone layer.
  • the fiber assemblage may not be completely submerged in the silicone, because if the assemblage were to become completely submerged the silicone might form a smooth surface over the submerged assemblage (embedding the assemblage in the silicone object). Rather, at least a portion of the fiber structure may remain unsubmerged in the silicone.
  • pressure is not applied to the assemblage once it has been pushed partially into the silicone surface. By discontinuing the applied pressure before the assemblage is settled entirely into the silicone layer, the process may ensure that the final surface is textured, e.g. that the surface has openings reflecting the structure of the assemblage of fibers.
  • the assemblage may be pressed entirely into the silicone material.
  • the process of creating a texture may include removing a portion of the silicone material after it has cured in order to expose the assemblage.
  • portions of the assemblage of fibers may be completely submerged in the silicone. In such cases, tubes may form in the resulting texture.
  • a single, unitary assemblage of fibers need not be used to imprint the silicone object.
  • multiple patches may be used to imprint the silicone surface.
  • more than one individual assemblage may be pressed into the uncured or partially cured silicone surface.
  • These patches may have the same characteristics as each other, or different patches may have different characteristics.
  • the patches may be applied in an overlapping or a non-overlapping manner.
  • the patches may be pressed into the silicone surface independently such that at least some of the patches used partially overlap along an edge of the patch (although the patches need not overlap at all). In such examples, the patches may remain entirely distinct throughout the imprinting process. In other examples, however, the overlapping sections of the patches may be joined together. For instance, some example embodiments may include heating, or applying pressure to, the patches, causing the patches to join together where they overlap. Alternatively, example embodiments may include applying an adhesive which may join the patches to each other, or may include stitching the patches together.
  • the silicone may be allowed to cure, in block 150.
  • the curing processes may be a traditional curing process. During this curing process the silicone may harden into its final form. Because the assemblage of fibers is imbedded in the silicone during the curing process, the silicone may harden into a form accommodating the shape of the imbedded fibers.
  • the silicone may be allowed to cure until the curing process is complete. Alternatively, the silicone may be allowed to partially cure before continuing the process. In some embodiments, the silicone is cured using constant heating or a particular ramping temperature program.
  • the assemblage of fibers may be removed from the silicone surface.
  • the fibers may be removed using any reasonable process which does not damage the silicone structure. Such processes may depend on the choice of polymer used for the fibers. For instance, in some example embodiments, a solvent may be applied to the surface, in which the polymer of the fibers is soluble, while the silicone is insoluble. In such embodiments the fibers may be dissolved entirely away, leaving behind the silicone object. In other example embodiments, other processes may be used to remove the fibers. For instance, the fibers may be removed hydrolytic degradation in some example embodiments. In other embodiments, the fibers may be removed through the application of heat, melting the polymer, or through the use of a physical retracting force.
  • the silicone surface which remains may be imprinted with a texture, e.g. the pattern of a mesh used.
  • the texture of the surface may have a structure which is a negative of the structure of the imprinting fibers.
  • the fibers of the assemblage used may leave pores and channels in the silicone surface, while other areas of the assemblage, e.g. the eyes of a mesh, may leave surface protrusions.
  • a silicone surface may be formed with channels, pores, and other structures which may together form a texture which effectively prevents the cells, which will eventually grow over the surface when implanted, from taking a planar configuration.
  • FIG. 3 illustrates an example breast implant 300.
  • the implant 300 may include an outer shell 301.
  • This outer shell 301 may be formed of any suitable material, for instance, silicone. Any other suitable material may also be used, however.
  • the outer shell 301 may have both an inner 302 and an outer surface 303.
  • the outer surface 303 may be a surface which is exposed to a patient's body when the implant 300 is in use.
  • the inner surface 302 may define an internal cavity 304 which does not come into contact with the patient's body.
  • This outer shell 301 may be constructed of a single piece of silicone material, or multiple pieces.
  • the shell 301 may be constructed out of two halves, which may be attached to each other to form a single shell 301 during the manufacturing process, using any reasonable connection technique (such as the application of additional silicone material).
  • each of the pieces may be individually textured (or partially textured), for example using the imprinting technique described above. In other embodiments, however, the pieces need not all have an imprinted texture.
  • the implant 300 may also include a filler material 305.
  • the shell 301 may form an internal cavity 304.
  • the shell 301 may be shaped as a closed bag.
  • This cavity 304 may be filled with a filler material 305 which may give the implant 300 volume and shape.
  • the filler material 305 may be any suitable material.
  • the filler material 305 may be a saline solution, or a silicone gel, or some other suitable material.
  • all or part of the outer surface 303 of the shell 301 may be imprinted with a texture 306 designed to alleviate the complications associated with capsule contracture.
  • FIG. 4 provides a close-up, top- down, illustration of the outer surface 303 of an example implant 300.
  • the surface 303 may be textured, rather than smooth.
  • a repeating pattern may be formed in the silicone surface 303.
  • the pattern may be formed in the silicone material of the surface itself, for example using an imprinting technique like that described above (e.g. employing a mesh of fibers).
  • the pattern formed in the silicone material of the surface need not have a repeating pattern.
  • the pattern may have a random structure, having been imprinted with an assemblage of fibers having a felt like structure.
  • the surface may include a number of structures, including pores 401 , protrusions 402, and channels 403.
  • such structures may be formed by the pattern of an assemblage of fibers used to imprint the surface 303.
  • the pores 401 and channels 403 may represent the portions of the surface which cured around a polymer fiber, while the protrusions 402 may represent areas of the surface where no fiber was present during the curing process, e.g. inside an eye of a mesh.
  • Such a pattern may provide a series of interconnected pores 401 , which may serve to prevent the formation of a planar configuration of capsule cells when the implant 300 is in use.
  • the interconnectedness of the channels 403 and pores 401 may enhance the disruption of such a planar configuration by encouraging cell growth in the recessed areas of the textured surface 303.
  • the texture pattern may have any configuration, e.g. size, pattern shape, etc., and may be a repeating pattern or may have a changing structure.
  • pores and channels need not be distinct features. Rather the pores and channels may simply refer to recessed features formed on a surface.
  • FIG. 5 provides a view of an example surface 303 from the side.
  • the surface pattern has both high and low points.
  • the raised areas may reflect the open areas of an assemblage of fibers (e.g. eyes of a mesh) which was used to imprint the surface, while the lower features may reflect places in which the fibers were pressed into the surface material during the curing process.
  • the relative difference in elevations of the various features may be determined by the thickness of the assemblage used, the thickness of the polymer fibers, the number of fibers, whether multiple layers were used, how deeply into the surface the assemblage was pressed, etc.
  • the average distance between the highest and lowest points in the pattern may be in the range of about 100 ⁇ to about 500 ⁇ , or about 100 ⁇ to about 1000 ⁇ . Such elevation changes may be sufficient to disrupt the formation of a planar capsule cell configuration.
  • FIGs. 6-7 illustrate an example surface imprinted with three layers of mesh.
  • FIG. 6 provides a top-down view of the pattern formed by the layers of mesh, and
  • FIG. 7 shows the corresponding side view.
  • the pattern imprinted in the silicone may again include a series of pores 401 , protrusions 402, and channels 403.
  • the structures may be of a size sufficient to discourage formation of a planar cell configuration in the capsule.
  • the pattern may be more complicated than in the case of a single mesh (or other assemblage of fibers).
  • structures may be formed on the surface 303 at an intermediate height.
  • portions of the imprinting fibers may become completely submerged in the silicone surface during the imprinting process.
  • tubes may be formed in the surface.
  • Such tubes may have openings to the surface where the polymer fibers entered and exited the silicone during the curing process.
  • implants 300 may have textured surfaces 303 including tubes formed through the surface 303.
  • a osteoprene mesh (poly(L-lactic acid)-co-trimethylenecarbonate mesh) is provided.
  • the mesh was custom-made by Poly Med Inc. (Anderson, South Carolina). It had an open hole, or pore size, of 485 X 195 m and a filament thickness of 285 ⁇ .
  • MED 6400 is a high temperature vulcanization (HTV) silicone available in 36 wt% of xylene (Nusil Technology, Santa Barbara, CA). Then, the mold with silicone dispersion was placed into a fume hood for 8 hrs to allow the xylene to evaporate. A 2"X2" osteoprene mesh was then placed on the surface of the above mentioned uncured silicone. A flat spatula was used to push the mesh to uncured silicone.
  • HTV high temperature vulcanization
  • FIG. 8A is an optical microscopic image of the silicone texture with the osteoprene mesh.
  • FIG. 8B is optical microscopic image of the silicone surface texture after the osteoprene mesh was removed.
  • FIG. 8C is an SEM image of the resulting silicone surface texture.
  • FIGs. 9A, 9B and 9C are optical microscopic and SEM images of silicone texture imprinted by two layers of osteoprene mesh (open hole, 485 X 195 ⁇ ; thickness, 285 ⁇ ).
  • FIG. 9A is an optical microscopic image of the silicone texture with osteoprene mesh present.
  • FIG. 9B is an optical microscopic image of the silicone surface texture after osteoprene mesh was removed.
  • FIG. 9C is an SEM image of a cross section of the resulting silicone texture.
  • FIG 10A is an optical microscopic image of the silicone texture imprinted by the osteoprene mesh.
  • FIG. 10B is an SEM image of the silicone surface texture after the osteoprene mesh was removed.
  • FIG. 1 1A is an optical microscopic image of the silicone texture imprinted by multi layers of the osteoprene mesh and FIG 1 1 B is an SEM image of the same.
  • FIG. 12A is an SEM image of the top of the silicone texture imprinted by two layers of the polycaprolactone mesh.
  • FIG. 12B is a cross-sectional SEM image of the same.
  • a method of making a porous material in a contoured shape generally comprises the steps of a) applying a matrix material to a contoured mold, applying a fibrous covering to the matrix material on the mold, treating the matrix material having the fibrous covering to cure or harden the matrix material on the mold, and removing the fibrous covering from the cured or hardened matrix material, wherein fibrous covering removal results in a porous material.
  • the fibrous covering may comprise a fiber assemblage that is generally in the shape of a three-dimensional covering, for example, shape having an open end for fitting onto a mold, and a closed end.
  • the fibrous covering may be in the form of, for example, a tube, or a sock, or other shape corresponding to the shape of a contoured mold.
  • the fibrous covering 1200 may be in the form of a mesh "sock" with a string 1202 or other suitable means for cinching or tightening the sock onto a contoured mold surface 1224 of a mold assembly 1230.
  • a relatively less fitted sock 1240 may be simply wrapped around the mold surface 1224 as shown in Fig. 13C.
  • the fiber assemblage can be a woven structure made of any of the materials described elsewhere herein which can be removed from the matrix material.
  • porous materials for example, silicone materials with porous structures
  • porous materials are created by using one or more layers, for example, multilayers, of removable polymeric socks.
  • the process for making porous silicone, with a base layer involves: 1 ) wrap multilayers of polymer socks onto a mandrel with a silicone base layer, 2) dip the mandrel, with wrapped socks, with silicone dispersion, 3) cure silicone, and 4) remove socks by solvent dissolution.
  • This process allows creation of an integral 3D silicone shell with the characteristics such as being relatively easy to fabricate in a desired shape without involving any lamination or adhesion process.
  • Breast implant shells may be made on a mandrel, using multilayers of polymer socks , e.g. socks comprising woven fibers of poly(L-Lactic acid), PLLA.
  • the bare mandrel, prior to any application of silicone dispersion, is wrapped with a layer of PLLA sock, which is tightened by a thread at the neck of the sock.
  • a second layer of PLLA sock is put onto the first layer of sock and tightened. The wrapping of socks is repeated until multilayer of socks are assembled.
  • the socks are applied to a bare mandrel, in other embodiments, the mandrel may first be contacted with or coated with a silicone dispersion prior to application of the socks.
  • the mandrel which is assembled with multilayer of PLLA socks is then dipped into silicone dispersion, e.g. 25 wt% of PN-3206-1 in xylene, and placed on a mandrel stand to allow xylene to evaporate.
  • silicone dispersion e.g. 25 wt% of PN-3206-1 in xylene
  • the mandrel with silicone-coated multilayer socks is placed into an oven at a certain temperature for predetermined time to cure the silicone.
  • the socks are then removed by soaking the cured silicone-socks composite into an organic solvent, e.g. methylene chloride, chloroform, acetone, or tetrahydrofuran.
  • the porosity, pore size, and pore interconnections are controlled by the parameters of meshes or socks, e.g. mesh open pore size and filament thickness, and the means of stacking meshes.
  • meshes or socks e.g. mesh open pore size and filament thickness
  • Parallel stacking socks will create a channel-like porous structure, random stacking, however, will create a more randomly interconnected porous material.
  • Figure 14 shows Optical Microscope and SEM images of porous silicone based materials made using a method of the invention as described herein.
  • a three dimensional elastomeric textured device useful as a component of a breast implant, was made as follows.
  • a conventional mandrel for forming a breast implant shell was dipped with 35% silicone and cured at 126 °C for 1 hour and 25 minutes.
  • the mandrel with cured silicone was dipped again with 35 wt% silicone, then placed into a fume hood to allow xylene to evaporate.
  • PLLA socks Three layers of PLLA socks are applied, one-by-one, onto the mandrel with silicone base layer.
  • the PLLA socks had open pore size of about 500 ⁇ X 500 ⁇ and filament thickness of about 500 ⁇ .
  • the mandrel with the multilayer of PLLA socks was dipped with 25% 3206 silicone, followed by cured at 126 °C for one hour and 25 minutes. The mandrel was allowed to cool to room temperature. Then it was dipped with 15% 3206 silicone, and cured at 126 °C for 1 hour and 25 minutes.
  • Silicone PN-3206-1 is available in available in 35 wt% of xylene dispersions from Nusil Technology, Carpinteria, USA. The dispersion of silicone is diluted with xylene to get a concentration of 25 wt%, 20 wt%, and 15 wt% respectively.
  • Optical microscopic images of the resulting silicone porous material are shown in Figs. 15A and 15B.
  • SEM images of the porous material are shown in Figs 15C and 15D, top view and cross section respectively.
  • Example 6 The same materials and procedure are followed as in Example 6, except instead of three layers of PLLA socks, 6 layers of PLLA socks are applied to the mandrel.
  • Optical microscopic images of the resulting silicone porous material are shown in Figs. 16A and 16B.
  • SEM images of the porous material are shown in Figs 16C and 16D, top view and cross section respectively.
  • Osteoprene mesh poly(L-lactic acid)-co-trimethylene carbonate mesh having pore size 484 X 508 ⁇ ; filament thickness, 335 ⁇ was made by Poly_Med Inc. 6309 Highway 187, Anderson, South Carolina 29625.
  • Silicone PN-3206-1 is available in 35 wt% of xylene dispersions from Nusil Technology, Carpinteria, USA. The dispersion of silicone is diluted with xylene to get a concentration of 25 wt%, 20 wt%, and 15 wt% respectively.
  • a few round pieces of osteoprene mesh (485X195) with a diameter of 1 10 mm were cut, stacked, layer by layer, and placed into a positive pressure filter. About ml of 35% PN-3206-1 was poured onto the top layer of the stacked meshes. Positive air pressure to remove excessive amount of silicone was applied. The silicone-coated meshes were placed onto an uncured silicone base layer and placed into an oven.
  • the silicone was cured at 80 °C for 4 hrs and 126 °C for 1 hour and 25 minutes to get silicone-mesh composite.
  • the mesh was removed by soaking the composite into methylene chloride, with solvent change for three times.
  • the silicone foams were dried in a fume hood.
  • Figs. 17 A and 17 B are SEM images, top view and cross sectional view, respectively, of the resulting porous silicone material made as described in this example, the materials having a thickness of about 600 ⁇ .
  • Example 9
  • Figs. 18A and 18B are SEM images, top view and cross sectional view, respectively, of the resulting porous silicone material, the material having a thickness of about 1500 ⁇ .

Abstract

Cette invention concerne un procédé permettant de fabriquer un implant en silicone à surface texturée. Le procédé consiste à fournir une matrice classique et à la recouvrir d'un manchon préformé en maille polymère. Le manchon est mis en contact avec une dispersion de silicone qui est ensuite au moins partiellement soumise à une vulcanisation. Une fois la vulcanisation terminée, le manchon est retiré par dissolution et laisse place à une matière élastomère texturée utilisée comme composant d'une coque pour implant mammaire.
PCT/US2012/056984 2011-09-26 2012-09-25 Implant en silicone texturé WO2013048978A1 (fr)

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CA2850132A CA2850132A1 (fr) 2011-09-26 2012-09-25 Implant en silicone texture
EP12769851.2A EP2760491A1 (fr) 2011-09-26 2012-09-25 Implant en silicone texturé

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Cited By (29)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3700380A (en) * 1970-10-01 1972-10-24 Tecna Corp Surface or lining compatible with blood or other tissue
US20110093069A1 (en) * 2009-10-16 2011-04-21 Allergan, Inc. Implants and methdos for manufacturing same

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3700380A (en) * 1970-10-01 1972-10-24 Tecna Corp Surface or lining compatible with blood or other tissue
US20110093069A1 (en) * 2009-10-16 2011-04-21 Allergan, Inc. Implants and methdos for manufacturing same

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